S. HRG. 107–404

Senate Hearings

Before the Committee on Appropriations

Departments of Labor,

Health and Human Services,

and Education, and Related

Agencies Appropriations

Fiscal Year 2002

107th CONGRESS, FIRST SESSION

H.R. 3061/S. 1536

DEPARTMENT OF EDUCATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

DEPARTMENT OF LABOR

NONDEPARTMENTAL WITNESSES

Labor-HHS-Education Appropriations, 2002 (H.R. 3061/S. 1536)

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70–756 PDF 2002

S. HRG. 107–404

DEPARTMENTS OF LABOR, HEALTH AND HUMAN

SERVICES, AND EDUCATION, AND RELATED

AGENCIES APPROPRIATIONS FOR FISCAL YEAR

2002

HEARINGS

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON APPROPRIATIONS

UNITED STATES SENATE

ONE HUNDRED SEVENTH CONGRESS

FIRST SESSION

ON

H.R. 3061/S. 1536

AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR,

HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED

AGENCIES, FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2002, AND

FOR OTHER PURPOSES

Department of Education

Department of Health and Human Services

Department of Labor

Nondepartmental witnesses

Printed for the use of the Committee on Appropriations

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
(II)

COMMITTEE ON APPROPRIATIONS

TED STEVENS, Alaska, Chairman

THAD COCHRAN, Mississippi

ARLEN SPECTER, Pennsylvania

PETE V. DOMENICI, New Mexico

CHRISTOPHER S. BOND, Missouri

MITCH MCCONNELL, Kentucky

CONRAD BURNS, Montana

RICHARD C. SHELBY, Alabama

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

MIKE DEWINE, Ohio

ROBERT C. BYRD, West Virginia

DANIEL K. INOUYE, Hawaii

ERNEST F. HOLLINGS, South Carolina

PATRICK J. LEAHY, Vermont

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

BYRON L. DORGAN, North Dakota

DIANNE FEINSTEIN, California

RICHARD J. DURBIN, Illinois

TIM JOHNSON, South Dakota

MARY L. LANDRIEU, Louisiana

STEVEN J. CORTESE, Staff Director

LISA SUTHERLAND, Deputy Staff Director

TERRENCE E. SAUVAIN, Minority Staff Director

SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

EDUCATION, AND RELATED AGENCIES

ARLEN SPECTER, Pennsylvania, Chairman

THAD COCHRAN, Mississippi

JUDD GREGG, New Hampshire

LARRY E. CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

TED STEVENS, Alaska

MIKE DEWINE, Ohio

TOM HARKIN, Iowa

ERNEST F. HOLLINGS, South Carolina

DANIEL K. INOUYE, Hawaii

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

MARY L. LANDRIEU, Louisiana

ROBERT C. BYRD, West Virginia

(Ex officio)

Professional Staff

BETTILOU TAYLOR

MARY DIETRICH

JIM SOURWINE

MARK LAISCH

ELLEN MURRAY (Minority)

ADRIENNE HALLETT (Minority)

ERIK FATEMI (Minority)

Administrative Support

CORREY DIVINEY

CAROLE GEAGLEY (Minority)
(III)

CONTENTS

TUESDAY, MARCH 6, 2001

Page

Work Safety and the Ergonomics Rule .................................................................. 1

WEDNESDAY, APRIL 25, 2001

Department of Health and Human Services: Office of the Secretary ................. 27

THURSDAY, APRIL 26, 2001

Ergonomics ............................................................................................................... 65

WEDNESDAY, MAY 2, 2001

Department of Labor: Office of the Secretary ....................................................... 201

THURSDAY, MAY 10, 2001

Department of Education: Office of the Secretary ................................................ 251

WEDNESDAY, MAY 23, 2001

Department of Health and Human Services: Office of the Secretary ................. 293

NONDEPARTMENTAL WITNESSES

Department of Education ........................................................................................ 417

Department of Health and Human Services ......................................................... 448

Related agencies/general testimony ....................................................................... 684

(1)

DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

TUESDAY, MARCH 6, 2001

U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC.

The subcommittee met at 9:39 a.m., in room SD–192, Dirksen

Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senator Specter.

WORK SAFETY AND THE ERGONOMICS RULE

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. Good morning, ladies and gentlemen. The Appropriations Subcommittee on Labor, Health and Human Services,

and Education will now proceed.

The hearing on ergonomics has been convened on very short notice, as we have not had much notice that the issue would be on

the Senate floor, which it is today, and I thought it would be useful

to hear from parties in the field, the representatives of the factions

which are in opposition to the current ergonomics regulation, representatives in favor of the regulation, and from the Associate Solicitor of Labor for OSHA, the Agency which had the responsibility

for promulgating the regulation.

I had a brief informal meeting with the parties in my office. We

will proceed now to try to address a number of the critical issues.

I would start with the question as to the views of the witnesses,

and I welcome Mr. Joseph M. Woodward, Esq., who is Associate Solicitor of Labor for OSHA, and Baruch Fellner, Esq., a partner at

Gibson, Dunn & Crutcher, practicing employment law with emphasis on occupational safety and health, and Lynn Rhinehart, Esq.,

associate counsel of the AFL–CIO. We will start with the baseline

question as to whether there ought to be any regulation at all. Mr.

Fellner, let me start with you on that first.

STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON, DUNN

& CRUTCHER, LLP

Mr. FELLNER. Based upon the science, the law, and medicine as

we presently know it, the regulation which OSHA has promulgated

is beyond the mark and is fatally flawed.
2

Whether there should be any regulation of ergonomics will and

should depend on the proper nonrush to judgment evaluation of

this extraordinarily complex area, and Secretary Chao in her confirmation hearings has emphasized precisely that, and that is,

these are issues which are inordinately complicated, both from an

economic as well as a scientific and medical perspective, and given

that, given the time frame that it took between proposal to final

in this instance, a time frame which the head of the OSHA effort,

Marthe Kent, referred to as a miracle if OSHA could promulgate

this standard in time—and by in time, we all know that that

meant before the close of the last administration.

Senator SPECTER. Then you are essentially saying there could be

a regulation, but it has to be properly formulated. What would you

recommend as the course to formulate such a regulation?

Mr. FELLNER. We would recommend what we recommended to

OSHA during the course of the hearings, and it was a recommendation that was echoed by the Chief Administrative Judge,

Judge Vittone, and that was, first, given the complexity of the

issues involved, the medical and scientific issues, it would be appropriate, it would be absolutely necessary to get into the same

room the major medical and scientific minds on both sides and let

them have, over a period of 2 or 3 days, or however long it took,

with appropriate overview from the Department of Labor, a full

and free discussion of what the science shows.

Senator SPECTER. Who should those people be?

Mr. FELLNER. We represent the National Coalition on

Ergonomics and a number of other petitioners in the lawsuit

against this litigation, or against this regulation. As part of that

lawsuit, we submitted statements from 21 of the world’s greatest

experts, amongst whom is Alf Nachemson. Alf Nachemson from

Sweden, is viewed as the greatest authority on low back pain, period, full stop. He has submitted a statement into the OSHA record

indicating that this standard is so ill-advised from an economic, a

medical and a scientific perspective, that it should not be promulgated. Alf Nachemson, N-a-c-h-e-m-s-o-n, and there are many others.

Senator SPECTER. How many such experts would you recommend

representing your side of the issue?

Mr. FELLNER. I would suggest, Senator Specter, that it might be

slightly premature to get into those specifics, but at least a halfa-dozen, half-a-dozen to a dozen experts from our side I would suggest, respectfully, from the appropriate medical side, and I would

also remind the chairman that two august medical bodies, the

American College of Occupational and Environmental Medicine,

representing over 100,000 occupational doctors, supporters of ergonomic principles from day 1, have written a specific letter opposing

this final standard. They should be represented. Two, the American

Academy of Orthopedic Surgeons submitted a comment into the

record opposing this proposed regulation. They should be represented, and if the other side wants to bring in their ergonomists

to represent their position insofar as what the medical and scientific issues reflect, by all means let them do so, but if I might

add, when we made that suggestion of a full and free discussion
3

with regard to these issues, OSHA declined, and declined in writing. That issue has to be redressed.

STATEMENT OF LYNN RHINEHART, AMERICAN FEDERATION OF

LABOR-CONGRESS OF INDUSTRIAL ORGANIZATIONS

Senator SPECTER. Before taking up, Mr. Fellner, with your specific objections to the regulation, let me ask Ms. Rhinehart what

her view is of such an interchange among experts.

Ms. RHINEHART. Well, Senator, I think that is a fine idea, but in

fact it has already happened. It has already happened a number

of times, the most recently the National Academy of Sciences recently issued a comprehensive report, and that was ordered by

Congress as part of the appropriations process 2 years ago.

The NAS issued a comprehensive report after reviewing all of the

literature on ergonomics, and this was a gathering of major scientific minds. As Mr. Fellner put it, this was a gathering of major

scientific minds, the National Academy of Sciences, and they came

out with a comprehensive report in January that found not only is

there a strong association between worker exposure to ergonomic

risk factors in the workplace, and development of ergonomic injuries, but also that interventions reducing those exposures was effective at reducing worker injuries.

Senator SPECTER. Did the National Academy of Sciences support

this regulation?

Ms. RHINEHART. The NAS, their job was to look at the science

and to make conclusions about what the science says at this point.

They were very explicit that they were not making policy recommendations, that their job was to look at science, not policy, so

they did not take a specific position on the ergonomics regulation.

However, their findings clearly support an ergonomics regulation.

They found that, as I said——

Senator SPECTER. Well, they clearly support regulation, but the

focused question is whether they support this regulation.

Ms. RHINEHART. They were not asked to support this regulation,

so they did not comment on this regulation.

Senator SPECTER. They were not asked to comment about this

regulation?

Ms. RHINEHART. Correct. They were asked to look at the science,

and they did, and they found the science supports ergonomic interventions.

STATEMENT OF JOSEPH M. WOODWARD, ASSOCIATE SOLICITOR OF

LABOR, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION,

DEPARTMENT OF LABOR

Senator SPECTER. Mr. Woodward, is it true, as Mr. Fellner says,

that OSHA specifically rejected a convocation of experts on both

sides?

Mr. WOODWARD. I believe he is referring to a letter that was

written during the course of the rulemaking proceedings for this

standard. In order to promulgate a standard, we have to follow certain procedures, which include public hearings and an opportunity

for comment. We were engaged in following those proceedings at

that time, which are all on the record and subject to certain requirements, so I believe it is correct that at that time we did not

take up that opportunity.
4

If I could make a few other points, first of all, I am here in a

technical capacity to try to help describe the rule and the issues in

the rule. I am not here to advocate a particular policy solution

here.

Senator SPECTER. Well, are you here to advocate the rule?

Mr. WOODWARD. I would like to note that the Agency has finalized a rulemaking, and that it found on the record that the criteria

for issuing an OSHA standard, in the agency’s view, as of last November, were satisfied. Those criteria are: is there a significant

risk of harm; is the harm material; and is there a feasible way to

reduce the harm. That was the finding that was made in November.

Any approach to ergonomics, if it is in a regulatory approach,

would have to follow the criteria that Congress has laid down, and

also the procedures. Since we issued the rule, a number of people

have filed lawsuits. Thirty-one lawsuits have been filed. A lot of objections have been raised to the rule. The Secretary has said that

these are very complicated issues that she wants to study carefully.

We are aware of the fact that many people have objected to the

provisions of the rule.

Senator SPECTER. Well, you give the reasons why you rejected

the idea of having experts on both sides come in, because, as you

describe it, you are in the middle of a rulemaking process. Do you

think that Mr. Fellner’s suggestion is a good one, if you are going

back to the start again?

Mr. WOODWARD. We always think it is a good idea to meet with

different people who have different viewpoints, and hear what they

have to say, because certainly you can learn something that way.

Senator SPECTER. Is that a yes answer?

Mr. WOODWARD. Yes. A meeting or a discussion is a good thing.

If the idea is to do a rulemaking, eventually you have to go through

the procedures I mentioned, and you have to make your decision

on the basis of the evidence.

Senator SPECTER. Do those procedures allow at some stage to

have the expertise that Mr. Fellner described convened and discuss

the matter?

Mr. WOODWARD. Certainly. There are public hearings where people can come in and say what they want and question each other.

Senator SPECTER. I do not think he is talking about a public

hearing, although it could be open to the public. Well, you can call

it a public hearing.

Mr. Fellner, coming to the substance of this regulation, what, in

your view, is wrong with it?

Mr. FELLNER. If I may be given a couple of minutes to address

that, Senator Specter, rather than a relatively brief period of time.

Senator SPECTER. Take whatever time you need, Mr. Fellner.

Mr. FELLNER. I appreciate it immensely. It is important to reflect, obviously, the perspective from which I come. I am an attorney. I represent the National Coalition on Ergonomics, and some

106 out of 136 petitioners in this matter and, in the interest of an

open record, it is important to recognize that I am an attorney reflecting those clients.

Having said that, and if you would allow me a personal digression, I have been practicing occupational safety and health law for
5

30 years. In my formative years as a lawyer I was in charge of

OSHA enforcement for a period of approximately 10 years, and it

is with a great deal of sadness and mixed emotion that I am here

today, speaking against a regulation from an agency for which I

have enormous respect and an agency which I believe has a very,

very important task in this country. It has gone too far insofar as

this particular regulation is concerned.

And let me emphasize, Senator Specter, what we are not opposed

to. We are not opposed to the voluntary application of ergonomic

principles in the workplace. Ever since the wheel was invented,

man has understood that it is preferable to use a wheelbarrow to

move rocks than it is to do it on his back. That is pure, sensible,

logical, you want to make the job as comfortable——

Senator SPECTER. Mr. Fellner, it does not advance the issue

much to say that you are in favor of voluntary compliance. Of

course, if it is voluntary, who would have any objection to that. The

issue moves from that as to whether you need something more.

Mr. FELLNER. That is right, and the question is whether this—

not whether you need, with all due respect, whether you need

something more, in the context of your first question to me, any

regulation. The issue before us this morning, with respect, is this

midnight regulation that we are talking about.

Senator SPECTER. Precisely. That is why I am asking you what

is wrong with it, in your view.

Mr. FELLNER. It is the most intrusive, most far-reaching micromanagement of American industry in the history of the Department of Labor. It is, to put it bluntly, bad law, bad economics, bad

science, and bad medicine, and if I could touch on all of those four

briefly this morning, I can give what I would think would be a complete response.

Senator SPECTER. That is fine. To the extent you can be specific

as to what there is in the regulation which is costly, which is inefficient, and which does not move to protect worker safety, we would

appreciate it.

Mr. FELLNER. Thank you. The final standard we are talking

about, Senator Specter, does a 180 from the proposal. The proposal

as a result of 21⁄2 months of hearings in which I participated, crossexamined OSHA’s witnesses. That proposal, I dare say the agency

concluded was vague to the point of being unconstitutional and, instead of going with the proposal, they went with a final standard

which was not the logical outgrowth, could not be anticipated from

that which was proposed, and let me give you one or two examples,

if I may.

The final standard contains nine mathematical formulas which

include basic screening tools and hazard identification tools to tell

the employer how to act, how to lift, what to move, what constitutes repetition. The final standard defines repetition as two motions performed within 1 minute over a 2-hour period of time. One

minute is interminable. I would challenge——

Senator SPECTER. Two motions?

Mr. FELLNER. Within 1 minute, which are repetitive. A repetitive

cycle is two motions within 1 minute over 2 hours.

We do not have the time this morning to take out a stop-watch,

and if you take out a stop-watch and determine how slow 1 minute
6

is, and how few two motions are, that is the stately pace that

OSHA would want American business to function at.

Senator SPECTER. I would like to have Ms. Rhinehart’s comment.

We will come right back to you.

Ms. RHINEHART. Thank you, Senator. I hesitate to guess exactly

what Mr. Fellner is talking about, but I believe he is talking about

the triggers that OSHA included in its final rule, triggers which

simply tell an employer, hey, your worker may be exposed to a hazard here, and you need to do a job analysis, fully analyze the job,

and see if your worker is exposed to a hazard.

Nowhere in this rule does it say that workers, or that employers

have to restrict workers to doing a motion less than two times a

minute. That simply does not appear anywhere in this rule.

Senator SPECTER. Mr. Fellner.

Mr. FELLNER. Yes. I would like to read page 68848 of the Federal

Register document.

Senator SPECTER. We will include that page in the record at this

point.

[The information follows:]
7

Mr. FELLNER. This is table W–1, which is the basic screening

tool. The left-hand column reads, ‘‘risk factors this standard covers.’’ The first one is repetition. In that first definition it says, repeating the same motions every few seconds, or repeating a cycle

of motions involving the affected body part more than twice a

minute for more than 2 consecutive hours in a work day. That is

OSHA’s definition of what it calls a risk factor this standard covers, which is repetition.

We always wanted during the course of this hearing for OSHA

to tell us how much is too much. They have, in their own words.

This is their definition of repetition, and while we are on this page,
8

Senator Specter, it also contains a definition of lifting 75 pounds

once. It also contains definitions which say, if you lift 25 pounds

below the knee, above the shoulders, or at arm’s length more than

25 times per day—25 pounds, 25 times a day—that constitutes

force, and on and on.

These are OSHA’s definitions of its risk factors. I would suggest

that economically the impact of these risk factors, were these to

trigger the kinds of job hazard analyses that Ms. Rhinehart indicates, the impact of these risk factors on our retrenching economy

would be devastating.

Moreover, there is not a scintilla of scientific evidence or medical

evidence to support these exercises in false precision.

Senator SPECTER. Mr. Woodward, how about it? What is your

view of what Mr. Fellner is arguing?

Mr. WOODWARD. I would like to clarify a couple of things here.

This table here, which we refer to as a screen, its only function is

to tell an employer whether it needs to take a look at a job. There

are no limits in here of the kind that would say you have to have

fewer repetitions than what is in the table.

The function of this table is, if an employee is injured, and you,

the employer, determine that that injury was because of work, then

look at this table and determine if there is at least that much exposure to risk factors here. The next step is to do a job hazard analysis to try to figure out whether there is a hazard. You can use any

reasonable method to do the hazard analysis.

In other words, if your employee is injured and he has acquired,

say, carpal tunnel, and you look at the job and yes, he does have

2 consecutive hours of repeating the same motion over and over

again, then you have to go further and look at the job in more detail to see whether or not it is actually a hazardous job. Put another way, if it is less than that, you stop. You do not even inquire.

You say, well, if there is less than 2 hours of exposure, I clearly

do not need to worry about this.

Now, let me qualify that. There are certain provisions of the

standard, not the control provisions, that are triggered when you

exceed this amount of exposure. A medical referral for a medical

evaluation and then possible work restrictions is triggered, and

training is triggered, but in terms of whether controls are triggered: no, the only requirement is to perform an analysis to try to

determine whether there is a hazard.

Just to clarify one other point, the definition is not twice per

minute. It says, repeating the same motions every few seconds, or

repeating a cycle of motions involving the affected body part more

than twice per minute, so there are two concepts in here. One is,

you are doing the same thing every few seconds for 2 hours in a

row without stopping. The other is a cycle that is a combination of

body motions, and whether you complete that cycle, go through the

full cycle more than twice a minute.

To go back to the other issue that was raised as to whether people have an opportunity to comment on this, that is one of the

issues that will be in the litigation. What the proposal said was

that if somebody was injured and if they were working, if they

were exposed for a significant amount of time to repetition, for example, then you should look at the job, but that phrase, significant
9

amount of time, was not defined in the text of the proposal, so I

think that is the point he is referring to.

There was some discussion in the preamble about scientific evidence indicating that the 2- and 4-hour level is something worth

looking at, but there was not anything particular in the text of the

proposal.

Senator SPECTER. Let me come back to the basic point here on

what this means. Risk factors this standard covers, and then we

have the specifics. Are you saying, Mr. Woodward, that even if the

employee’s activities fall within those definitions, that there is not

necessarily a violation?

Mr. WOODWARD. Correct. This is a tool that is part of a process.

Senator SPECTER. It is a tool as part of the process, but that triggers an inquiry as to whether there is inappropriate work required

of the person?

Mr. WOODWARD. That is correct, whether there is a hazard.

Senator SPECTER. Then what comes next to make a determination as to whether, if that is done, there is a hazard?

Mr. WOODWARD. Then what the standard says is that the employer should do a hazard analysis.

Senator SPECTER. What about a hazard analysis?

Mr. WOODWARD. It says if these levels are exceeded, the employer must do a hazard analysis, and it says that there are several

different methods an employer could use to do a hazard analysis.

One method is to hire a professional, a safety and health person

who is knowledgeable in the area and knows something about ergonomic principles. Another method is to use one of the enumerated

tools that are listed in the standard, and I think Mr. Fellner was

referring to these tools as well as something that he believes the

public needed more opportunity to comment on, but these are tools

that are in the nature of safe harbors. If you want to use any one

of these tools to conduct a hazard analysis you can do that, that

is allowed. Finally, you can do any other approach that is reasonable.

Senator SPECTER. Mr. Fellner, your point is that these factors

occur, then a hazard analysis is triggered, and there has to be a

determination as to whether there is a hazard which is unacceptable, is that your point?

Mr. FELLNER. Yes, in part. If I could expand on that a bit, Senator Specter, and that is, first of all let me address one of the

things that Mr. Woodward said insofar as this screening out injuries. The word injury is not used in the standard. It is a musculoskeletal disorder incident.

That term is defined in the context of a list in the standard of

subjective symptoms, including pain, simply pain, tingling, cramps.

That constitutes an MSD incident. Then question is whether any

of these screening criteria which we refer to in table WD–1 screen

anything out. The answer is no. That, in turn, triggers a job hazard

analysis.

The job hazard analysis and its consequences, which is the mandated use of nine tools that have not been associated in any way,

shape, or form scientifically with eliminating ergonomic risk factors

or eliminating MSD incidents, those nine tools have to be used, and

you have to constantly implement engineering controls, reengineer
10

your workplace in compliance with these mandated tools, so the

process, soup to nuts, is the identification of these hazard screens,

these action triggers, which in turn——

Senator SPECTER. I am going to come back to that. Ms.

Rhinehart has not had a chance to respond, and I see her anxiously

edging forward toward the microphone. Ms. Rhinehart, what is

your view?

Ms. RHINEHART. Thank you. I would just like to back up, if I

could, and put some of this in a little bit of context. OSHA in this

ergonomics rule essentially codified an approach to ergonomics that

many companies are already following, that the General Accounting Office has recommended as an effective approach to

ergonomics, that NIOSH recommends as an effective approach to

ergonomics, that the NAS in its recent report suggests is an effective approach to ergonomics.

It is a very broad and very flexible approach to ergonomics that

has employers follow very basic program elements of job hazard

analysis, hazard identification and control, involves their workers

in that process, provides some basic training. These are elements

that have been out there and in use ever since at least the 1990’s,

the late 1980’s, the 1990’s, when the Department of Labor put out

its guidelines for addressing ergonomic problems in meat-packing

plants.

These basic elements that are in the final rule were part of those

red meat guidelines. They have been part of settlement agreements

that OSHA has reached with many companies. Many companies

have voluntarily adopted ergonomics programs centered around

these principles, and there is a reason why they have, because they

work.

There are countless examples in the rulemaking record, Senator

Specter, where companies that have implemented ergonomic programs centered around these principles have found that not only

are they able to reduce worker exposure to hazards, they have reduced worker injuries, and they have reduced the costs associated

with those injuries in terms of Workers Comp costs, lost productivity, other health costs, not to mention the sparing workers and

their families the impact that these injuries have.

These are serious, debilitating injuries that occur at a rate of

about 600,000 serious injuries per year, and the impact of these injuries on workers and their families is simply devastating.

There are effective, known measures centered around these

broad principles contained in the final rule to address this problem

and to reduce that suffering, and save employers money in the

process, and that is why we think that it is important that we have

a final ergonomics standard on the books that frankly has been—

it has been 10 years in the making. It has been a long time coming.

It is no rush to judgment. But fortunately, finally the time has

come, and we do have these ergonomics protections on the books

that we strongly support.

Senator SPECTER. Mr. Fellner, your position is what? What about

Ms. Rhinehart’s statement that these standards represent a great

many practices which have been accepted in the industry and by

these other agencies?
11

Mr. FELLNER. This standard did not receive 10 years of scrutiny.

It did not receive 10 minutes of scrutiny insofar as notice and comment is concerned. This standard as a regulatory requirement,

which on pain of penalty from compliance officers, taking this

standard out and enforcing it has not been part of anybody’s

ergonomics program.

Senator SPECTER. Is there a pain of penalty if somebody has the

repetitive motion of more than twice per minute for more than 2

consecutive hours in a work day? Is there a pain of penalty for

some employer who permits that kind of work to go forward?

Mr. FELLNER. If some employer permits that kind of work to go

forward without undertaking the job hazard analysis and the mandated tools, in Appendix D–1 the answer is absolutely yes. It is

those action triggers that start the ball rolling.

Senator SPECTER. Now, the job-mandated analysis on specified

tools, elaborate as to what that means exactly, and why you are opposed.

Mr. FELLNER. Job hazard analysis—and we are opposed to that

because we have seen this in the context of OSHA having issued

over 550 general duty clauses—citations under its omnibus authority for ergonomics issues.

The job hazard analysis and what OSHA has required pursuant

to those citations have involved everything from reengineering the

workplace, slowing the pace of the workplace, hiring more workers,

reducing the weight, changing the entire configuration of conveyer

systems.

There are comments in the record, Senator Specter——

Senator SPECTER. Mr. Fellner, what would you recommend, or

the ancillary question is, do you believe that there is not a problem

if someone has to do more than twice a minute the same activity

more than two consecutive hours in the work day? Do you think

that is not a problem, or an indicator of a problem which requires

further analysis to decide whether it is a hazard?

Mr. FELLNER. That is correct.

Senator SPECTER. You do not think that means anything?

Mr. FELLNER. I would suggest, with all due respect, that that indicates how far OSHA has gone if they honestly believe that repetition is doing something twice a minute, twice a minute for 2 hours,

and that that triggers—the word they use is action trigger, that

that triggers action, including the worker removal protection,

which is independently triggered by that.

Senator SPECTER. What is the worker removal test?

Mr. FELLNER. The worker removal protection is 90 days at 90-

percent pay if one has a subjective MSD incident that I described

earlier.

Senator SPECTER. 90 days at 90-percent pay in some other job?

Mr. FELLNER. No, sitting at home doing no other job. 90 days at

90-percent pay. We are talking about the most favored injury

clause. If you compare this with any other injury, an amputation

would not yield the same——

Senator SPECTER. Okay, I understand your point.

What kind of repetitive activity do your experts think would be

hazardous?
12

Mr. FELLNER. That is an extraordinarily complex question, as

complicated as the human being is, and I would respond——

Senator SPECTER. It is up to a man of your experience to answer.

Mr. FELLNER. I would respond by saying, with respect, look at

the answer of sports medicine. Sports medicine teaches you that

repetition is not bad, but good. Repetition strengthens the human

body. The basic medical premise on which ergonomists have based

this standard is that we are a series of ball-bearings, we human

beings, and that we are going to wear out over time.

If anyone has an aged parent, if anyone is dealing with recovery

from injury, we know that motion is not bad, but repetitive motion,

and difficult repetitive motion, is good for the human body, striking

that balance. It is a difficult balance.

Senator SPECTER. Mr. Fellner I am trying to zero in on issues

which I think will be of concern not only to me but to my colleagues. Are you saying that there is no problem with repetition no

matter how much repetition there is?

Mr. FELLNER. I am saying that that is a question for free and

open debate amongst the experts.

Senator SPECTER. What do your experts say? You must know

what they say on the subject. If you are disagreeing with the standard, what is the standard?

Mr. FELLNER. Again, we are not in the position to draft a standard in this hearing room, and I would not be in a position to condense the experts’ views in this hearing room.

Senator SPECTER. I was thinking of providing 6 to 12 persons on

each side to come into this room and have a discussion about it.

Mr. FELLNER. That is not a bad idea.

Senator SPECTER. When you come down to this next one, lifting

more than 75 pounds at any one time, or more than 55 pounds

more than 10 times a day, or more than 25 pounds below the knees

or above the shoulders or at arm’s length more than 25 times a

day, I think about my experience in my father’s junkyard. At 17,

I could lift 100 pounds, but it was tough, and we had joints of 2-

inch casing, tubing, 25 feet long, which three of us threw on a

truck, and more than 100 pounds was tough.

What happens with women? Are women called upon to lift 75

pounds in their jobs? Are they, Ms. Rhinehart?

Ms. RHINEHART. Absolutely, Senator. One of the industries with

the highest rate of back injuries and other ergonomic injuries is

nursing homes. Nurses’ aides and other workers in nursing homes

are required to lift patients who often weigh more than 100

pounds, and often they are required to lift these patients on their

own, and as a result of that, the rate of injuries in that industry

is rampant.

Can I just go back for 1 second to the repetitions?

Senator SPECTER. Stay with nursing homes for a second. What

is to be done? Is someone to be with the employee at all times to

help them lift the patient?

Ms. RHINEHART. There are a couple of things that were discussed

extensively in the rulemaking hearings, either that you have somebody assist you in lifting a patient, or there are actually mechanical devices that are out there and in use in hospitals and in nursing homes and in other settings that assist a worker in moving a
13

patient, and which takes some of the weight and some of the load

off of the worker while still permitting the patient-handling that

needs to be done to occur. So those devices are out there.

Senator SPECTER. You had another point you wanted to make.

Ms. RHINEHART. I just wanted to, on the point of repetition and

how much repetition is too much, I would just refer you—and I

would be happy to provide this for the record—to some of the very

compelling testimony during the OSHA rulemaking hearings from

poultry workers, who have birds coming past them on a line at a

rate of 70 birds per minute, and they have to pull these birds down

and make motions and cuts on those birds, 70 birds a minute,

every minute, every hour, and I would suggest that when you take

that repetition and combine it with the effect of that repetition on

workers, the skyrocketing rates of injuries, that is too much.

Senator SPECTER. I am trying to figure out how to get there from

here. I do not know what the repetition standard ought to be, and

I do not know what the weight-lifting standard ought to be, but the

question, Mr. Fellner, is how we get there, and you do not like

what is being done here, and if you convened experts in all of these

fields who give their testimony, then you would leave it up to

OSHA to make a judgment as to which expert testimony was correct, and they would then make up a chart like this one on risk

factors this standard covers. Then there would be an opportunity

for the parties to comment, and then OSHA would consider those

comments and come to a final conclusion. That is what you are

suggesting, Mr. Fellner?

Mr. FELLNER. That is—definitely, assuming that the new OSHA

concludes that one can segregate the physical factors, which is

what we have talked about, and limited our discussion this morning, from the myriad of other factors acknowledged by the World

Health Organization, the National Academy of Sciences, and others, including psychosocial factors, social factors, cultural factors,

gender, genetics, and a variety of other factors, all of which contribute to these MSD incidents that we talked about before.

And assuming that the new OSHA concludes, as well, that it is

in a position to distinguish that which takes place in the workplace

from that which is caused outside of the workplace, especially since

there is so much of a conglomeration, if you will, of these factors

together.

Assume that all of these pieces can be appropriately understood

by the new OSHA, and assume that physical factors can be segregated from all of the rest which have been acknowledged even by

the experts that Ms. Rhinehart relies on. Then what you have described is an entirely appropriate way of approaching the issue, but

the assumptions are not yet well understood.

Senator SPECTER. Let us go to the issue of cost. What has OSHA

estimated the cost to be, Mr. Woodward?

Mr. WOODWARD. OSHA estimated the cost of this standard at

roughly $4.5 billion per year. This is an annualized cost; there are

several components to that estimate. There is the cost of the program elements. In other words, you have to train employees according to this standard. That takes time. That is a cost. There is the

cost of the controls that you would have to put in if you find that

there is a hazard that needs to be controlled. There is also the cost
14

of the work restriction protection, maintaining an employee’s earnings, if you determine the employee is injured and that he cannot

perform his normal duties.

Senator SPECTER. How do you come to the figure? What is your

methodology?

Mr. WOODWARD. The biggest single part of it, according to OSHA, is the program cost. Those were roughly $2 billion, a little more

than that.

Senator SPECTER. How do you determine that?

Mr. WOODWARD. The current standards requires employers to do

various things. They have to set up a system by which employees

can report their injuries to them. They have to give employees information about these type of injuries. They have to train them.

They have to do hazard analysis. What OSHA did is to list those

activities and then try to figure out how much time it typically

would take an employer to do that. That computation was in the

final rule largely based on testimony about existing ergonomics

programs.

People testified about their ergonomics programs. For example,

it takes us x hours to train our employees, and other people had

a different estimate, and they said, it takes us y hours. The agency

reviewed those estimates and came out in the middle. Basically,

that was how OSHA calculated the program part of the cost.

For the work restriction protection part, OSHA received from

BLS an estimate of how many workers are currently off work due

to this type of injury. Then OSHA made an adjustment because

they think there is underreporting, and that the real number, after

this standard goes into effect would be greater since more people

would be reporting their injuries.

Then OSHA looked at what BLS says is the median amount of

time people are out of work because of these injuries. I think it is

7 days for musculoskeletal disorders as a whole, although it varies

depending on which type of disorder you are talking about.

That was how OSHA calculated the number of days, and then

they looked at the earnings in different industries and occupations

and made an adjustment for the fact that some of this is currently

being covered by Workers’ Compensation. OSHA subtracted that

amount from the cost, since that was already being borne, and from

that they obtained an estimate of $600 or $700 million a year. I

believe it was an estimated $630 million a year.

Then there was the control cost presented, what OSHA termed

it, difficult issues related to costing. What OSHA did was convene

a panel of practicing ergonomists and asked them to estimate what

they thought, based on their experience, on average, it would cost

to fix a hazardous job in a particular occupational grouping. Based

on that, the experts then tried to estimate, how many people are

in that occupational grouping in different industries and obtained

an estimate.

Senator SPECTER. Was there a calculation as to benefit as a result of the regs to offset the cost?

Mr. WOODWARD. Yes.

Senator SPECTER. What was that figure?

Mr. WOODWARD. OSHA estimated 4.6 million disorders would be

prevented over the first 10 years, and there was a partial monetary
15

value assigned to that. In other words, OSHA did not try to cost

pain and suffering, but they did estimate that there was about $9.1

billion of other value from the rule.

Senator SPECTER. What is the total value, Mr. Woodward, calculated by OSHA?

Mr. WOODWARD. $9.1 billion, I believe.

Senator SPECTER. What do you think about those figures, Mr.

Fellner?

Mr. FELLNER. Those figures make this the most expensive regulation in OSHA’s history, and those figures are minuscule compared to what the real figures are. The litmus test for what this

standard will cost American industry lies in the citations that

OSHA has issued over the last 10 years on ergonomics. These are

citations that will be issued by the same compliance officers using

the same measures, the same tools, and the same requirements for

fixes.

We have for a number of clients taken a look at the specific recommendations that OSHA has made to fix these risk factors that

we have talked about earlier, and we put a price tag on them. That

price tag is anywhere between $100 billion and $1 trillion, and lest

that be viewed as an exaggeration, we must continue, we in industry, under this standard which is the subject of this hearing, we

must continue to experiment and force technology until we are

down to the screening tools, so that the action triggers are no

longer activated, because we know we are going to get those MSD

incidents. We know we are going to get complaints with regard to

back pain.

So consequently the process by which—for example, there is a

comment filed by Federal Express in the record which, simply put,

states that next-day delivery will cease if the OSHA standard is

promulgated. There is testimony in the record, as you can well

imagine, from funeral directors indicating that burials will no

longer take place if the precise kinds of requirements in this standard are, in fact, effectuated.

Senator SPECTER. When you say burials will not take place, do

you mean they will be delayed?

Mr. FELLNER. No. I am suggesting to you, Senator Specter, you

cannot lift a human body, unless it is wasted down to below 75

pounds, and that is what I am suggesting, and that is what the testimony in an uncontradicted fashion indicates in the record.

Senator SPECTER. What about that, Mr. Woodward?

Mr. WOODWARD. There is nothing in the rule that says you cannot lift a person who is more than 75 pounds. I do want to acknowledge that, as the Secretary has said, these are very complicated issues. Many issues have been raised about the way the

current rule is structured, and we acknowledge that, and we are

in litigation. No briefing schedule has been set, no oral argument

set, but we acknowledge that a number of issues have been raised

about it.

Senator SPECTER. Mr. Fellner, how do you get to your calculation of $100 billion to $1 trillion in cost?

Mr. FELLNER. If one were to take across the vast array of American industry the specific requirements, and we are not talking

about the hours it would take to absorb. I am not sure whether Mr.
16

Woodward said it takes 1 hour or 2 to absorb this 608-page standard, together with its preamble.

We are not talking about the number of hours that it takes to

study and understand an incomprehensible regulation. We are

talking about the nuts and bolts, as I indicated to you earlier, that

it would take to comply, after the job hazard analysis, with this

regulation. This is not a matter of putting a phone book under a

desk, which some of our union friends have indicated.

This is not simply a matter of simple, quick fixes. This is experimenting with pace, with employees, with automation, and the bottom line here, the great irony here is that our friends in the labor

movement, who are very, very much behind this standard—and I

acknowledge the good faith with which they approach the arguments favoring this standard, as I did 2 weeks ago when Lynn and

I were on an ABA/OSHA subcommittee panel together discussing

the very same issues.

The issue is not that good faith. The great irony is that this

standard will push two things, one, jobs going abroad, and two,

automating employees out of jobs, because robots do not complain

about low back pain.

Senator SPECTER. Mr. Fellner, can you come to grips a little more directly with the way you come to the computation of cost of $100

billion to $1 trillion?

Mr. FELLNER. The Employment Policy Foundation has submitted a detailed document indicating that the range is $100 billion without relying on the specific numbers for implementing these 5(a)1,

these general duty clause citations.

Senator SPECTER. What is the basis of that computation?

Mr. FELLNER. The basis of that computation is using a more realistic analysis of the hours, the time, and the implementation of job

hazard controls.

Senator SPECTER. They say $100 billion?

Mr. FELLNER. They say in excess of $100 billion, and that is part

of the record.

Senator SPECTER. Do they say as much as $1 trillion?

Mr. FELLNER. They do not say as much as a trillion. That reflects

an extrapolation from specific 5(a)(1) citations, which I indicated

earlier.

Senator SPECTER. Who made that extrapolation?

Mr. FELLNER. We did, in the context of our submissions to the

OSHA record.

Senator SPECTER. Mr. Woodward, what do you think about that?

Your $4.5 billion compared to their $100 billion?

Mr. WOODWARD. OSHA explained its reason in some detail, and

OSHA concluded that most of these fixes were relatively inexpensive, more in the range of $800 to $1,000, to fix a hazardous job.

That was based largely on testimony of what people currently do

to abate a hazard. There is a huge range, so we are talking about

an average. Some people disagreed with that.

One reason some of the other estimates are so high is because

they interpreted the provisions of the standard differently than

OSHA interpreted them. For example, one requirement is to provide your employees information about musculoskeletal disorders—

what are they, what they should be aware of—so they can report.
17

One of the cost estimates was based on the idea that it would

take 60 hours with each employee to convey that information,

whereas OSHA’s interpretation of the requirement, was that you

could simply provide a written explanation to the employee of what

to look for. So I think there are some differences in how the standard was interpreted. That is one of the factors.

Because we were in rulemaking, the estimates were directed toward the proposed rule, and there were some differences with the

final rule. I think that also is a factor here.

Senator SPECTER. Mr. Fellner, did your computations take into

account a benefit contrasted or similar to what Mr. Woodward has

testified to? When he says there were $4.5 billion in cost, he says

there were $9.1 billion in benefits. Did your analysis take into account the benefit factor?

Mr. FELLNER. In point of fact, our analysis indicates that the

benefits are largely overdrawn. The BLS statistics upon which they

are based are roundly criticized by the National Academy of

Sciences, which is seeking properly a much more sophisticated

analysis of the so-called MSD incidents. The BLS statistics are

much too rough a tool.

Senator SPECTER. Is there no benefit?

Mr. FELLNER. As a matter of fact, the initial—as OSHA concedes,

the initial stage of this ergonomics standard will be iatrogenic, and

by that I mean it will increase the number of MSD incidents that

are reported in the workplace, because to a certain extent we are

teaching employees how to be sick, and in the context of heretofore

having coped with musculoskeletal pain and discomfort, and overcome it, as all of us do, OSHA would turn the tables on that particular point, and so in many respects the benefits that OSHA has

indicated are illusory, and if I may further add, Senator——

Senator SPECTER. Is that a no answer?

Mr. FELLNER. No, it is not a no answer. We do acknowledge that

there may be some benefits, as there would in the so-called Hawthorne effect. Turning your attention to any problem will, from a

variety of different perspectives, potentially ameliorate those problems, and that is a psychosocial aspect of that amelioration.

But let me, if I may——

Senator SPECTER. You may, but first tell me if you have a figure

on benefits. You say that there may be benefits. Do you have a figure on benefits?

Mr. FELLNER. I do not.

Senator SPECTER. You were pretty fast on $100 billion to $1 trillion, but no figure on benefits?

Mr. FELLNER. If I were to accept, which I do not, the $9 billion

number that OSHA has put forth in the context of the standard,

it is swallowed up by the costs, so as we see them and as they are

demonstrated clearly in the record, i.e., $9 billion in benefits, even

assuming that were accurate, is more than swallowed up by their

$100 billion to $1 trillion in costs.

So under the circumstances benefits is a negligible factor in this

equation, particularly, if I may, if one looks at what Mr. Woodward

has indicated is one of the methodologies of determining benefits,

which is getting their selected ergonomists in a room with a huge

range, insofar as the benefits and the costs that they determine of
18

this standard, a huge, inconsistent, subjective range, if their way

of coming up with benefits of interventions is, as one of the case

studies, quote-unquote, which they rely on, which is a Continental

Air magazine——

Senator SPECTER. I think I have your point.

Mr. FELLNER [continuing]. Which was taken out of a seat. That

is the way they determine benefits.

Senator SPECTER. With $4.5 billion in costs and $9.1 billion benefits estimated by OSHA, and your figures of $100 billion in costs

ranging up to $1 trillion. I am trying to find some basis for rational

congressional evaluation of what is going on here and it is a swirl.

It is an absolute swirl.

I do not understand much of what Mr. Woodward says as to his

$4.5 billion in costs, and I understand less from what you have said

of the range of $100 billion to $1 trillion. That is a pretty big range,

and if we go through the rulemaking process again, how is there

going to be an evaluation?

One of the things I asked in a meeting that I held informally

that you did not attend, Mr. Fellner, was the possibility of bringing

the contestants together to see if something could be worked out,

to see if there could be some agreement.

When the telecommunications bill was passed with all its complexities, the parties finally got together, and we do facilitate that

from time to time. Is there any possibility of doing that, Mr.

Fellner, so that experts can draw the lines of disagreement and

compromise?

Mr. FELLNER. In the context of this regulation the answer is no.

Senator SPECTER. How about the next regulation, if there is one?

Mr. FELLNER. The answer is yes, obviously, if there is one.

Senator SPECTER. This massive regulation, which I have heard

described as 300 pages, and then I have heard it further described,

and correct me if I am wrong, Mr. Woodward, as nine pages of regulations, 16 pages of fact sheets in support, and the balance of public comments, is that accurate, Mr. Woodward?

Mr. WOODWARD. That is correct.

Senator SPECTER. Is that accurate, Mr. Fellner?

Mr. FELLNER. That is inaccurate.

Mr. WOODWARD. The rest of the package is what we call the preamble. It is an explanation of the rule, and it is a justification in

terms of the evidence, the scientific evidence that was presented,

and the economics.

Senator SPECTER. But you are saying there are only nine pages

of regulation.

Mr. WOODWARD. The regulatory text, yes, that is correct.

Mr. FELLNER. Any employer, if I may interrupt, any employer

who would attempt to take action based upon 9 pages of standard

and 16 pages of fact sheets without knowing what is in the preamble, given my experience insofar as OSHA standards are concerned, with much shorter preambles than this, is engaged in a

very risky business.

To understand the standard is to understand OSHA’s interpretations in its preamble. Indeed, we will not know what OSHA means

by this standard until it comes out with its enforcement directive,
19

which it has declined to do up until now, because there is extraordinary confusion as to what this standard means.

Senator SPECTER. How about that, Mr. Woodward? How about

the enforcement directives?

Mr. WOODWARD. We normally do issue what we call a compliance

directive. As I said, the Secretary has noted that these are complicated issues, and that the entire standard has been under review. We have not issued a compliance directive yet. The compliance directive does not change the meaning of the nine pages of

text. It cannot do that. But any of these materials can interpret the

rule and, to that extent, provide guidance.

Senator SPECTER. The issue has been raised as to whether any

new regulation, if this one falls under the Congressional Review

Act, will be fatally inhibited by the provision in the statute which

precludes a new rule, if it is reissued in substantially the same

form. Is there any problem at all, as you see it, Mr. Fellner, in having a new regulation which will be permitted under the Congressional Review Act, and not prohibited by being substantially in the

same form by the rule prohibiting a regulation: ‘‘reissued in substantially the same form’’?

Mr. FELLNER. This being the first time that the CRA will be tested, we are clearly in uncharted waters as to what substantially the

same form means, so let me very carefully and very gingerly respond to your question, Senator Specter, and suggest that a standard that contains the kind of very specifically mandated formulae

and definitions that this standard contains, and would hold employers to those definitions and to those requirements, and I am

specifically talking about W–1, which we talked about earlier, as

well as appendix D–1, that that kind of standard may very well fall

in the substantially similar rubric, as outlined by the CRA, but we

do not know that, and we will not until good lawyers like Lynn and

hopefully myself test it in the courts.

Senator SPECTER. So there is some possibility that there might

be some litigation?

Mr. FELLNER. After the next standard comes out, that is correct,

there may very well be.

Senator SPECTER. Do you think there is any conceivable possibility there would not be enormous litigation?

Ms. RHINEHART. Two years ago at an ABA meeting I

promised——

Senator SPECTER. Wait a minute. I want to hear his answer.

Mr. FELLNER. Do I think it is——

Senator SPECTER. Do you think there is any possibility at all, any

remote, contingent possibility that there would not be litigation

that a new regulation is barred by the substantiality requirement

I just read?

Mr. FELLNER. The answer is, if we all do our jobs, and we come

up with a consensus, there is a good chance that litigation could

be avoided.

Senator SPECTER. Ms. Rhinehart, you wanted to say something.

Ms. RHINEHART. I did. I just wanted to——

Senator SPECTER. I did not want to let you come in before Mr.

Fellner had a chance to answer.
20

Ms. RHINEHART. And the fact that they may not sue OSHA over

a subsequent standard is welcome news indeed. I just wanted to

say that the AFL–CIO is very concerned about the impact of passage of a resolution of disapproval under the Congressional Review

Act on the agency’s ability to issue a standard in this area in the

future, and I think what we have just heard from Mr. Fellner is

evidence as to why we are right to be concerned.

OSHA made some modifications in this final rule to be a little

more specific, and to give employers some more guidance because

the employers asked for it. Now we are hearing from Mr. Fellner

that they do not like that specificity, and they want to go back to

a broad, more general standard. Well, that is what they had, and

they did not like that, either.

The fact of the matter is that many trade associations and a

large part of the employer community has vociferously opposed any

ergonomics regulation, so the notion that if Congress were to pass

this resolution of disapproval and send OSHA back to the drawing

board, that there would be a change of heart and all of a sudden

we would all be collaborating and embracing a new rule in the future seems a bit far-fetched, in our view, and so we are very concerned about the effect of passage of a resolution on OSHA’s future

ability to act.

We would like to believe they could act. We obviously are very

interested in there being a good, strong ergonomics standard to

protect workers, and we will do everything we can toward that end,

but we are very concerned.

Thank you.

Senator SPECTER. Does anybody care to comment any further?

Additional statements for the record will be included at this point,

including a letter from Secretary Chao.

[The statements follow:]

PREPARED STATEMENT OF LPA, INC.

Mr. Chairman and Members of the Subcommittee: LPA is pleased to submit testimony opposing the Occupational Safety and Health Administration’s (OSHA’s) final

ergonomics standard, which has been estimated by the Employment Policy Foundation to impose annual costs on employers of as high as $126 billion, probably making it the most expensive workplace regulation in history. The final standard, which

OSHA completed in less than 11 months, was less an attempt to promulgate a

sound workplace regulation than the fulfillment of a political promise by President

Clinton to organized labor. Politics should give way to reasonable regulation, and

thus Congress should invalidate the standard using the Congressional Review Act,

allowing OSHA to try again.

LPA, Inc., is an association of the senior human resource executives of more than

200 leading corporations in the United States. LPA’s purpose is to ensure that U.S.

employment policy supports the competitive goals of its member companies and

their employees. LPA member companies employ more than 12 million employees,

or 12 percent of the private sector workforce. If the final ergonomics standard remains in effect, it will cover nearly all of our member companies and virtually all

of their employees.

In short, LPA supports the application of ergonomic principles to the workplace.

However, it opposes the final ergonomics standard because it covers ergonomics disorders caused by non-work activities, is not based on sound science, ensures that

most employers will be required to set up ergonomics programs, and creates unacceptable conflicts with state workers’ compensation laws. Instead, LPA supports the

Senate joint resolution of disapproval sponsored by Sen. Don Nickles (R-OK), S.J.

Res. 6, which would invalidate the final standard and allow OSHA to regulate workplace ergonomics in a more reasonable manner.
21

Final standard covers non-work-related disorders

OSHA’s final ergonomics standard fails to substantially narrow the definition of

work-related musculoskeletal disorder (MSD). The final standard purports to cover

workrelated MSDs, but broadly defines that term as those that work caused, contributed to, or for pre-existing MSDs, significantly aggravated. The Preamble defines ‘‘significantly aggravated’’ as having an injury already ‘‘but because of the employee’s exposure to identified risk factors in the workplace, the MSD has progressed to the extent that medical treatment is now necessary.’’ Reading between

the lines, this means that if work exposure played any role in an employee-reported

MSD, then the MSD is work-related.

NAS study shows that final standard not based on sound science

One of the key arguments in opposition to the final ergonomics standard is that

OSHA has failed to conclusively prove that work factors cause MSDs. The National

Academy of Sciences (NAS) study completed in January 2001 was intended to solve

this debate. The study reviewed existing scientific literature in order to determine

whether science has affirmatively linked injuries to workplace exposures. However,

it only demonstrated that more research was required in this complex area.

The NAS panel concluded that ‘‘[n]one of the common musculoskeletal disorders

is uniquely caused by work exposures,’’ that there are no comprehensive national

data on medically defined MSDs, and that the available data is mostly based on employee reporting, not a diagnosis from a health care provider. It cautioned that often

it is difficult to scientifically distinguish work exposures that may cause MSDs from

other life exposures that cause them because 80 percent of the population works,

further complicating research on the issue. The panel concluded that significant additional research is needed in this area.

The NAS panel also noted that MSDs are affected by many non-work factors, such

as age, gender, healthy lifestyles, and the effect of other diseases such as diabetes.

The panel spent a considerable amount of time discussing how psychosocial factors,

such as high perceived stress, low job satisfaction, monotony, and low social support

increase the chances of developing an MSD in the lower back.

Despite the unspoken preference for unanimity in such reports, the NAS panel

drew a rare dissent from panel member Dr. Robert Szabo. Dr. Szabo criticized the

panel for using inaccurate scientific literature, particularly regarding carpal tunnel

syndrome. He highlighted the studies that indicated that personal factors, age, lifestyle and sex as more predictive of carpal tunnel syndrome than job exposure. He

also noted that the cited studies only demonstrate that job controls reduce the

symptoms of disease but do not address whether they reduce the underlying soft tissue disease. Taken as a whole, the evidence cited by Dr. Szabo with respect to carpal tunnel syndrome casts doubt on the remainder of the NAS conclusions.

Triggers easily met

Once an employee has reported a work-related MSD, an employer must set up a

full ergonomics program if the reported MSD meets two ‘‘triggers’’ or tests set under

the standard. The first stage of the trigger is met if the MSD involves days away

from work, work restrictions (such as the inability to work scheduled or mandatory

overtime) or medical treatment beyond first aid. It is also met if an employee feels

tingling or other MSD symptoms in his or her arm for seven consecutive calendar

days. Given that it in not unusual for employees to experience symptoms or to request work restrictions occasionally, the first trigger is often met.

Once the first stage of the trigger is met, the employer must determine whether

the employee’s job exceeds certain action thresholds. In many cases these thresholds

are also easy to meet. For example, an administrative employee who regularly

works steadily at his or her keyboard for four hours or more per day would trigger

a full ergonomics program for all people performing similar jobs, if he or she reported a work-related MSD and was unable to work overtime for one day.

Taken together, the overbroad definition of work-related and the low job task

thresholds mean that the standard will cause most jobs to be covered by the

ergonomics standard.

Standard interferes with State workers’ compensation laws

The final ergonomics standard would require employers to provide 90 days paid

leave at 90 percent of an employee’s gross earnings to any employee who has been

determined unable to work by a health care professional. This requirement, called

‘‘work restriction protection,’’ is a blatant violation of section 4(b)(4) of the Occupational Safety and Health

Act (OSH Act), which states that an OSHA standard may not ‘‘supercede or in

any manner affect’’ any state workers’ compensation law.
22

The ergonomics standard will interfere substantially with state workers’ compensation laws in several ways, including:

—preempting the exclusive remedy provisions;

—invalidating state standards on injury and causation;

—undermining the return-to-work incentive; and

—increasing state costs because of increased claims and benefit duration.

Although OSHA has proposed and enforced work restriction protection provisions

in other, narrower standards, it has never attempted to apply it in a wide-ranging

standard that applied to virtually all general industry employees. Because the

ergonomics standard would apply to most employees of most employers, significant

conflict between the work restriction protection requirement in the OSHA standard

and state workers’ compensation laws is a virtually certain, and thus, illegal.

LPA urges support for congressional resolution of disapproval

Mr. Chairman, because OSHA’s final ergonomics standard is fundamentally

flawed, LPA recommends that Congress invalidate the current standard by passing

S.J. Res. 6, the joint resolution of disapproval introduced by Sen. Nickles. If the

Senate and the House of Representatives both approve the resolution by a simple

majority vote, and it becomes law, the ergonomics standard is invalidated.

Contrary to the assertions of organized labor and other opponents of the resolution, a successful resolution would not prevent OSHA from issuing an ergonomics

standard. Rather it would preclude OSHA from re-issuing the current standard or

one that is substantially similar. LPA believes this is a reasonable and measured

step to take given the great costs to the economy, employers, employees and states

imposed by the existing standard.

CONCLUSION

OSHA’s final ergonomics standard is unworkable because it applies to disorders

that are not related to work, is based on inadequate science and would cause a substantial conflict with state workers’ compensation laws. LPA endorses the attempt

to pass a congressional resolution of disapproval to rid the country of this flawed

standard and to allow OSHA to pursue a more reasonable approach.

Thank you for the opportunity to present our views.

PREPARED STATEMENT OF THE AFL–CIO

NATIONAL ACADEMY OF SCIENCES/INSTITUTE OF MEDICINE REPORT SUPPORTS THE OSHA

ERGONOMICS STANDARD

The National Academy of Sciences and the Institute of Medicine recently released

their long awaited report on Musculoskeletal Disorders and the Workplace. The report, requested by industry groups and conservative Republicans who opposed an

OSHA ergonomics standard, finds that there is strong scientific evidence showing

that exposure to ergonomic hazards in the workplace causes musculoskeletal disorders and that these injuries can be prevented. Prepared by some of the world’s

top scientific and medical experts in ergonomics, the report calls MSDs an important national problem and strongly supports the approach that OSHA took in its

final Ergonomics Program Standard, released November 14, 2000.

This is the third comprehensive review of the scientific literature over the past

four years that has come to the same conclusions. The National Institute for Occupational Safety and Health (NIOSH) published a comprehensive review of the data

on the relationship between MSDs and the workplace in 1997. The NAS also came

to similar conclusion in an earlier report published in 1998.

The NAS report puts to rest, once and for all, the claims by some industry groups

and conservative Republicans that there is no scientific evidence that workplace exposures cause musculoskeletal disorders. It shows without question that OSHA’s

new ergonomics standard is needed and justified.

Musculoskeletal disorders are an important national health problem

The NAS report confirms OSHA’s estimates of the scope of the problem, citing an

even larger number of workers losing time from work than OSHA. The NAS estimates that one million people lose time from work each year due to these disabling

injuries, compared with OSHA’s more conservative estimate of 600,000. The NAS

also confirms OSHA’s estimate that ergonomic problems cost the economy around

$50 billion each year. The report warns that MSD-related problems are expected to

increase in the future due to the changing nature of work, the aging of the workforce and rising numbers of women entering material handling and computer jobs.
23

The report also finds that existing national data sources conclude that construction and agricultural workers, who were not covered in the OSHA standard, also

suffer higher rates of work-related MSDs than overall industry.

‘‘There is no doubt that musculoskeletal disorders of the low back and upper extremities are an important and costly national health problem . . . In 1999, nearly

1 million people took time away from work to treat and recover from work-related

musculoskeletal pain or impairment of function in the low back or upper extremities. Conservative estimates of the economic burden imposed, as measured by compensation costs, lost wages, and lost productivity, are between $45 and $54 billion

annually.’’ (Page ES–1)

‘‘The consequences of musculoskeletal disorders to individuals and society and the

evidence that these disorders are to some degree preventable justify a broad, coherent effort to encourage the institution or extension of ergonomic and other preventive strategies.’’ (Page ES–6)

‘‘As the workforce ages and as more women enter the workforce, particularly in

material handling and computer jobs, evaluation of work tasks, especially lifting,

lowering, carrying, prolonged static posture, and repetitive motion, will be required

to guide the further design of appropriate interventions.’’ (Page 11–2)

Science strongly supports the fact that there is a strong relationship between workplace physical tasks and the risk of MSDs

The NAS found a strong and consistent pattern of evidence from both epidemiologic studies (studies of groups of people experiencing similar exposures), as well as

‘‘biomechanical’’ evidence (the actual damage that ergonomic stress does to muscles,

tendons and nerves.) The report cites the same workplace risk factors that OSHA

cites in its standard—heavy lifting, repetition, force, frequent bending and twisting

(awkward postures) and vibration. The report actually goes beyond the OSHA

standard, including whole body vibration as a risk factor for back injuries, where

OSHA only regulates hand-arm vibration.

While more research and better quality studies are clearly desirable, the NAS report finds that the consistent overall pattern of evidence from existing studies clearly confirms the relationship between workplace physical exposures and MSDs.

‘‘The basic biology and biomechanics literatures provide evidence of plausible

mechanisms for the association between musculoskeletal disorders and workplace

physical exposures.’’ (Page ES–6)

‘‘The panel’s review of the research literature in epidemiology, biomechanics, tissue mechanobiology, and workplace intervention strategies has identified a rich and

consistent pattern of evidence that supports a relationship between the workplace

and the occurrence of MSDs of the low back and upper extremities.’’ (Page ES–3)

‘‘The panel concludes that there is a clear relationship between back disorders and

physical load; that is, manual material handling, load movement, frequent bending

and twisting, heavy physical work, and whole-body vibration. For disorders of the

upper extremities, repetition, force and vibration are particularly important workrelated factors.’’ (Page 11–10)

‘‘Occupations that involve repetitive lifting, e.g. warehouse work, construction and

pipe fitting, particularly when that activity involves twisting postures, are associated with an increased risk for the complaint of low back pain and, in a few studies,

an increased risk for lumbar disc hemiation.’’ (App. A–6)

‘‘Low back disorder risk has been established through epidemiologic studies of

work that involves heavy lifting, frequent bending and twisting and whole body vibration, as well as other risk factors . . . . Biomechanical studies reinforce the epidemiologic findings.’’ (Page ES–3)

‘‘The pattern of evidence for upper extremity disorders, as for the low back, also

supports an important role for physical factors, particularly repetition, force and vibration. The most dramatic physical exposures occur in manufacturing, food processing, lumber, transportation and other heavy industries, and these industries

have the highest rates of upper extremity disorder reported as work related.’’ (Page

ES–4.)

‘‘There is strong support across these bodies of work that high force and repetition

are associated with musculoskeletal disorder of the upper extremities; basic biology

data provide evidence of alteration in tissue structure.’’ (Page ES–4)

‘‘These exposure-response associations persist when adjusted for individual factors

that may increase vulnerability, such as age, gender and body mass index.’’ (Page

ES–4)

‘‘The BLS and workers’ compensation data are sufficient to (1) confirm that the

magnitude of the work-related musculoskeletal disorder problem is very large; (2)

demonstrate that rates differ substantially between industries and occupations con-
24

sistent with the assumption that work related risks are important predictors of

musculoskeletal disorders.’’ (Page 2–17)

Science strongly supports the fact that workplace interventions based on ergonomic

principles can reduce the risk of MSDs

The report also confirms the fact that using ergonomic principles to reduce exposure to risk factors reduces the risk of MSDs. Changing the design of tools and

workstations, rotating jobs and other ergonomics interventions such as lift tables

and vibration dampening seating devices that reduce ergonomic risk factors have

been shown to reduce the risk of MSDs of the low back and upper extremities.

‘‘The weight of the evidence justifies the introduction of appropriate and selected

interventions to reduce the risk of musculoskeletal disorders of the low back and

upper extremities.’’ (Page 11–2)

‘‘The intervention literature supports the efficacy of tool and workstation design

changes, job rotation, and other interventions that directly address these risk factors with regard to upper extremity symptomology.’’ (Page ES–4)

‘‘Intervention studies have shown how lift tables and lifting hoists are effective

in mediating the risk of low back pain in industrial settings. Since risk is lowered

when the load is changed from a heavy lift to a light lift, this finding is also consistent with the rigorous epidemiologic finding.’’ (Page ES–3)

‘‘Based on the current evidence, modification of the lifting can reduce symptoms

and complaints. Specific successful strategies, which include ergonomic interventions (such as the use of lift tables and other devices and matching the worker’s capacity to the lifting tasks), administrative controls (such as job rotation), and team

lifting, appear successful. Despite enthusiasm for their use, there is marginal or

conflict evidence about lifting belts and education programs in reducing low back

pain in the population with heavy lifting requirements.’’ (Page App. A)

The NAS report supports the main elements included in the OSHA standard

The NAS Report found that employers with effective-ergonomics programs use a

programmatic approach that OSHA adopted in its standard. The OSHA standard

requires employers to include several basic program elements in approaching ergonomic problems: Management Leadership and Employee Participation, Job Hazard

Analysis and Control, Training, Medical Management and Program Evaluation.

These are the same common elements that the NAS report found in successful

ergonomics programs. This programmatic approach provides a framework for employers; it does not dictate how employers are to address the problems. The standard fully allows and anticipates that employers will tailor their programs to meet

the own specific needs of their workplace and work organization. The NAS report

found this approach to be effective in small and large companies from a variety of

industries.

‘‘To be effective, intervention programs should include employee involvement, employer commitment and the development of integrated programs that address equipment design work procedures and organizational characteristics.’’ (Page ES–6 and

11–2)

‘‘The complexity of musculoskeletal disorders in the workplace requires a variety

of strategies that may involve the worker, the workforce, and management. These

strategies fall within the categories of engineering controls, administrative controls,

and worker-focused modifiers. The literature shows that no single strategy is or will

be effective for all types of industry; interventions are best tailored to the individual

situation. However, there are some program elements that consistent recur in successful programs:

‘‘1. Interventions must mediate physical stressors, largely through the application

of ergonomic principles.

‘‘2. Employee involvement is essential to successful implementation.

‘‘3. Employer commitment, demonstrated by an integrated program and supported

by best practices review, is important for success.’’ (Page App. A–6)

‘‘These findings are based on a research and development process that tailors

interventions to specific work and workers conditions and evaluates, on a continuing

basis, the effectiveness of these interventions in the face of changing workplace and

worker factors. It is therefore neither feasible nor desirable to propose a generic solution.’’ (Page ES–5)
25

PREPARED STATEMENT OF THE AMERICAN HEALTH CARE ASSOCIATION

AHCA PRAISES USE OF CONGRESSIONAL REVIEW ACT TO RESCIND ERGONOMICS

REGULATION

WASHINGTON, DC.—The American Health Care Association (AHCA) today praised

Senator Don Nickles (R-OK) and Senator Mike Enzi (R-WY) for invoking the Congressional Review Act in their effort to rescind a 600-page ergonomics regulation

due to become law unless quick action is taken by Congress.

‘‘Our membership is actively working to help ensure this excessively burdensome

regulation does not become law, and we’re pleased to work with Senators Nickles

and Enzi on this critical issue,’’ stated Charles H. Roadman II, M.D., President and

CEO of AHCA. ‘‘This ergonomics rule would impose yet another crushing financial

burden costing long term care providers $1.2 billion at a time when we are being

squeezed on many different fronts. We have to be strong advocates for our patients

by being zealous guardians of the scarce resources allocated by the government for

long term care.’’

Late last week, Nickles, Enzi and several other Senators introduced a ‘‘resolution

of disapproval’’ under the Congressional Review Act. If the resolution is approved

by a simple majority in the Senate and House, and is signed by the President, the

ergonomics rule will not become law.

Dr. Roadman reiterated AHCA’s position that reducing work-related injuries and

protecting employees is best accomplished not through costly new federal regulations, but through ongoing voluntary efforts that are already working. AHCA has

supported, created and promoted ergonomic programs to improve workplace safety

for the caregivers in long term care for nearly a decade.

‘‘We believe the proposed rule will actually reverse the positive trend toward

lower rates of workrelated injuries because it will divert limited resources away

from further improvements,’’ said Dr. Roadman. ‘‘Just as the federal government

has started to correct the errors made in the implementation of federal Medicare

cuts, the last thing providers need is a new federal regulation that will drain $1.2

billion of scarce resources out of facilities to implement on a nationwide basis.’’

COPY OF THE LETTER SENT TO ALL U.S. SENATORS AND HOUSE MEMBERS

March 1, 2001.

[Each Letter was Personally Addressed and Signed to Individual Members of Congress]

On behalf of the American Health Care Association (AHCA), a federation representing over 12,000 non-profit and for profit nursing home, assisted living,

subacute and ICFMR providers of long term care nationwide, I am writing to urge

your strong support of the Congressional Review Act and your vote for the resolution of disapproval of the OSHA Ergonomic regulation.

Let me state up front that AHCA has supported, created and promoted ergonomic

programs to improve workplace safety for the caregivers in long term care for a decade. As caregivers our primary mission is to treat our patients and provide them

with a high quality of life. This can only be successfully accomplished if our employees work in a safe, secure, and healthy environment.

The fact of the matter is that the incidences of musculoskeletal disorder (MSD)

injuries in long term care have been in decline, and continue to decline. Bureau of

Labor Statistics (BLS) data show that from 1993 to 1997 sprains and strains numbers (the number one problem for health care employees) declined by 16.7 percent.

BLS data released in December 1999 shows the decline to be continuing. Clearly,

current programs and voluntary efforts to reduce MSDs are working. Indeed, AHCA

believes that the ergonomics final rule will actually retard and even reverse this

positive trend toward lower rates of work-related injuries.

Long term care employers are in a box with no way out with respect to the resources available to them to help pay for this new standard. Medicaid or Medicare

pays for the medical care for nearly 80 percent of residents in nursing facilities

today. AHCA has estimated that the first year’s cost for long term care facilities is

almost $1.2 billion. The reality is that there is no way to increase prices to pay for

the costs of this standard. The $1.2 billion will have to come from existing patient

care resources, with questionable employee safety benefit from the rule’s implementation.
26

We strongly urge you to prevent this regulatory attack on caregiver resources, and

allow a more reasoned approach to intelligent safety programs. Thank you for your

attention to this critical vote.

Sincerely yours,

CHARLES H. ROADMAN II, MD,

President and CEO.

LETTER FROM SECRETARY ELAINE L. CHAO

SECRETARY OF LABOR,

Washington, March 6, 2001.

Hon. ARLEN SPECTER,

Chairman, Subcommittee on Labor, Health and Human Services, Education, Committee on Appropriations, U.S. Senate, Washington, DC.

DEAR CHAIRMAN SPECTER: It is my understanding that the Senate will soon consider a Joint Resolution of Disapproval pertaining to the Occupational Safety and

Health Administration’s (OSHA) ergonomics standard. As you are aware, the Congressional Review Act of 1996 gives Congress the authority to vitiate this standard

and permanently prevent OSHA from promulgating a rule in substantially the same

form.

Let me assure you that, in the event a Joint Resolution of Disapproval becomes

law, I intend to pursue a comprehensive approach to ergonomics, which may include

new rulemaking, that addresses the concerns levied against the current standard.

This approach will provide employers with achievable measures that protect their

employees before injuries occur. Repetitive stress injuries in the workplace are an

important problem. I recognize this critical challenge and want you to understand

that the safety and health of our nation’s workforce will always be a priority during

my tenure as Secretary.

I look forward to working with you throughout the entire 107th Congress.

Sincerely,

ELAINE L. CHAO,

Secretary of Labor.

SUBCOMMITTEE RECESS

Senator SPECTER. Thank you very much, Mr. Woodward. Thank

you, Mr. Fellner. Thank you, Ms. Rhinehart.

Thank you very much, that concludes the hearing. The subcommittee will stand in recess until 9 a.m., Wednesday, April 25,

when we will meet in room SD–192 to hear from HHS Secretary

Thompson.

[Whereupon, at 12:15 p.m., Thursday, March 6, the subcommittee was recessed, to reconvene at 9 a.m., Wednesday, April 25.]
(27)

DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

WEDNESDAY, APRIL 25, 2001

U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC.

The subcommittee met at 9 a.m., in room SD–192, Dirksen Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Stevens, Specter, Harkin, Kohl, Murray, and

Landrieu.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

OFFICE OF THE SECRETARY

STATEMENT OF TOMMY G. THOMPSON, SECRETARY OF HEALTH AND

HUMAN SERVICES

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. This meeting of the Subcommittee for Labor,

Health, Human Services and Education will now convene.

We are pleased to have the distinguished Secretary of the Department of Health and Human Services, former Governor of Wisconsin, the Honorable Tommy Thompson. This is your first appearance before our subcommittee on a formal basis, but both Senator

Harkin, the distinguished ranking member, and I have had opportunities to meet with you and talk about priorities, your plans, and

our inputs into the very very important Department which you are

heading.

The Department has discretionary funding under the administra- tion’s budget this year for $51.5 billion, which is approximately

$2.5 billion above the fiscal year discretionary allowance for the

year we are in now. There are a great many very, very, important

programs which your Department is administering. You have come

up with increases in some very important areas, and there have

been some decreases in some important areas which we will want

to discuss with you.

In the interest of time, I am going to ask that my full statement

be included in the record. As I told the Governor yesterday and

again this morning, these days are all busy, and we appreciate you

coming over early for a 9 a.m. session. The judiciary committee has

a session at 10 a.m., which I expect to Chair shortly after it is con-
28

vened for Senator Hatch, and I know Senator Harkin has commitments, so we will move right along. I am now delighted to yield to

my partner, Senator Tom Harkin.

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. Thank you very much, Mr. Chairman, and

again, it is always a pleasure to work with you in your capacity as

chairman of this very important subcommittee. It is my pleasure

also to welcome Secretary Thompson today to testify about the

2002 budget.

First of all, Mr. Secretary, I am pleased to see that both NIH and

community health centers have received significant increases in the

budget. Kudos to you and to the President for that.

I am also glad that you have continued funding for the construction of new laboratories at the Center for Disease Control and Prevention, Atlanta. I understand you visited there yourself and saw

how important this work is and how those old buildings need to be

upgraded——

Secretary THOMPSON. Thank you very much, Senator.

Senator HARKIN. So I am really happy that you did that.

I am also encouraged that the administration has shown strong

support for the real choice system change grants by including them

in the President’s new freedom initiative for people with disabilities. The chairman and I worked hard to include funds for these

grants in last year’s bill, and we look forward to working with you

on this and other Medicaid reforms that will allow people with disabilities and the elderly to live at home in the community.

I might just paraphrase as an aside here, Mr. Secretary, when

the President came and met with the Democratic caucus, we had

a Democratic group meeting here a month or two ago or something,

and he came and visited us. He said that money ought to follow

an individual, not a program. You ought to focus on the individual,

and the President is right on that.

When it comes to people with disabilities, that the money——

Secretary THOMPSON. That’s true.

Senator HARKIN [continuing]. Ought to follow the person with

the disability rather than a program, and if the person wants to

live in the community, they ought to be able to do that. And so I

said, we need some changes in Medicaid. He took notes on that, so

I know that it registered with him. I am glad to see that you are

continuing this program and hopefully we will be able to help get

the funds for it.

On a little other down note, though, I am disappointed that there

are some other public health programs and a number of programs

for children that did not fare as well, Mr. Secretary. A few weeks

ago on the budget debate, Senator Specter and I worked on an

amendment that was passed, that shifted money from the tax cut,

mostly to education, but there was also money in there to make

sure that kids could get ready to learn.

In 1989, President Bush, then Governor Bush and the Nation’s

Governors met in Charlottesville, West Virginia.

Secretary THOMPSON. That is correct.

Senator HARKIN. And they came up with some national goals for

schools, education. The first goal was that every child should be
29

ready and able to learn by the year 2000. Last year has come and

gone and we have not gotten there. Well, I do not think that we

ought to give up on it, we ought to just recommit ourselves to it.

So I guess what I’m talking about is Head Start, an early learning

fund, and quality child care, programs that come under your purview at your department. There were monies in the amendment to

fully fund the Head Start program, and to fund the early learning

fund at the authorized level.

Now I have got to tell you that I am disappointed that the budget eliminates the early learning fund, and I hope we can work to

get that back in, Mr. Secretary.

The budget also cuts child care funding for infants and toddlers,

and there is no expansion for Head Start. Now I am not going to

say that this is absolutely certain, but from our initial read of the

Head Start funding for next year, it looks as though about 2,500

kids are going to be cut out of Head Start under the budget. Now,

if I am wrong, I would like to be proven wrong on that, but from

the initial run that we have seen on that, with all of the quality

programs and stuff built in there, the discretionary money that is

left over will actually serve 2,500 kids less next year.

Take a look at that please. I am not certain that is true, but that

is the first kind of run we took. If that is the direction we are

going, we have to do more under your purview on that.

So these are priorities that I hope to work with you and other

members of the subcommittee on, to do.

Now, one last note, Mr. Secretary.

Secretary THOMPSON. Yes.

Senator HARKIN. In Iowa and in Wisconsin and in a lot of other

States, our people are paying as much in for Medicare as any other

State in the Nation, but what we get back, our reimbursement rate

in Iowa is $2,900, and in Louisiana it is $7,000. I do not know

where Alaska falls, but I bet it is down there somewhere.

And so, what I am saying, there is such a huge disparity in our

reimbursement rates, I think Wisconsin is probably right down

there with us someplace too, I think, so it is unfair to seniors in

Iowa and those who live in rural States. If we just looked at the

average for the United States and take where Iowa is in that average, we are losing a billion dollars a year that we have by rights

coming in to take care of our elderly.

Secretary THOMPSON. Senator, when I was Governor of Wisconsin, I would have changed our reimbursement rate for Iowa. We

got treated even worse.

Senator HARKIN. You were worse than Iowa? Well, we are next

to last, and I know you are not the last now, so you must be up

above us somewhere right now, but you know what I am talking

about.

Secretary THOMPSON. I know.

Senator HARKIN. And we are going to introduce legislation to address this and try to get a better national average, and I hope to

work with you on this issue. Thank you, Mr. Secretary.

Secretary THOMPSON. Thank you, Senator.

Senator SPECTER. Thank you very much, Senator Harkin. We are

joined today by our distinguished chairman of the full committee,

Senator Stevens.
30

OPENING STATEMENT OF SENATOR TED STEVENS

Senator STEVENS. Thank you very much, Mr. Chairman. Mr. Secretary, we are delighted you are taking on this task and with your

background we are even more delighted, because we know what

you have done in your own State. I am really pleased that you have

stopped by to visit me, and I am sure you are visiting everyone else

to talk over the future of your area.

I want you to know that I am concerned about the progress of

keeping our commitment to double NIH funding. I really commend

Senator Specter and Senator Harkin for their initiative in carrying

this forward. Baby boomers are coming at us fast and if we do not

get this science completed in order to deal with their problems in

a different way than we have dealt with our generation, I think it

is going to be extremely costly for the United States. The investment that we are going to make in health care research I think will

pay off great dividends.

I do support your efforts and the administration’s efforts—I think

Senator Bond has been the leader up here on this concept—to double funding for community health centers. However, I have to tell

you that until this year, my state received only $7 million out of

the total of $1.1 billion for community health centers. I found that

the authorizing legislation and the regulations in your department

hinder smaller rural isolated communities like those we have in

our state from participating in that program. I hope that the community health center legislation that we develop to reauthorize this

program will eliminate those barriers to the participation of frontier communities in America in the community health center program.

Your budget eliminates the funding for what we call our Denali

Commission, to build clinics in remote Bush communities in Alaska. There are 271 of those, Mr. Secretary. I hope to get you up to

see our state soon, not just to the capital and our major city, but

out to the Hooper Bays and the Scammon Bays, and the various

areas that have tremendous problems.

Forty percent of the 271 native villages do not have water and

sewer systems. And these are communities that have no tax base,

they are completely surrounded by federal property. They have unemployment rates in excess of 80 percent on a structural basis.

There is no way that they can develop their own funds for health

services.

We developed the Denali commission so it could handle funds

from several different agencies, merge them together, and do a

comprehensive development in each village, instead of going into

one village with water and sewer one year, and into another one

the next year, and having different concepts coming in from HUD

or from EPA. We have tried to put them all together so that when

they go to the village, they do a comprehensive job that is less expensive and more productive in terms of producing good benefits.

It is one of the things I hope you really look at, because we put

an overhead ceiling of 5 percent on the Denali commission. The

overhead at your department is 30-plus percent on monies that go

to rural areas. There is just no reason to handle money that way,
31

particularly when several departments are needed to deal with the

problems of one single small rural village.

I think if you take the time to come up, we can show you how

you can be of great help and save money in the long run.

The one really sad thing I want to discuss with you, and Senator

Harkin has already mentioned that, and that’s the initiative I developed which was called the Early Learning initiative. Your budget eliminates $20 million for that. It is not a lot of money, and I

do support the first lady’s reading program. There is no reason not

to have them both.

But the early learning initiative is a comprehensive approach to

preparing children for school and I think it is absolutely essential

in these times. We listened to the Secretary of Education yesterday

concerning the problems of reading throughout the country, and it

seems that no matter how much money we put into the Department of Education, the reading levels are not going up. This is one

small amount that will, we believe, bring those reading skills up

more rapidly than much of the billions of dollars that have been

spent in the past, so I urge you to take a look at that.

But again, I welcome you and look forward to working with you,

and I am sure that it is going to be an interesting time for you.

I appreciate your service. Thank you very much.

Secretary THOMPSON. Thank you very much, Senator Stevens.

Senator SPECTER. Thank you very much, Senator Stevens.

Our practice, Mr. Secretary, is to put your full statement in the

record and ask you to hit the highlights and summarize it as you

see fit, so the floor is yours.

Secretary THOMPSON. Senator Stevens, before you leave, I would

just like to say thank you, and I will be looking forward to traveling to Alaska this summer and discussing it with you, and I hope

to be working with you on the Denali Commission.

Senator STEVENS. Let me see if I can develop some of your other

skills.

SUMMARY STATEMENT OF HON. TOMMY G. THOMPSON

Secretary THOMPSON. I am not very good at it but I will certainly

try, and if the chairman asks me to do it, I will do it.

Good morning, Chairman Specter, and thank you for your kind

introduction and your friendship for many years and I appreciate

that. And Senator Harkin, thank you for doing the wonderful job

you do in the neighboring State of my home State. I have watched

you with a great deal of interest and support for many years, and

I apologize to you for not being able to get to see you personally,

but I will be making every attempt to do so very quickly. I want

to meet all the Senators in their office, and I look forward to that.

I am honored, Senators, to appear before you today to discuss the

President’s fiscal year 2002 budget for the Department of Health

and Human Services. I will make this very short, because I know

both of you have to leave and I know you want to ask questions

and I want to answer them.

But several weeks ago I appeared before the colleagues of the

Senate Budget Committee to discuss the President’s fiscal year

2002 budget framework. Since that time, much has been written

and said about selected portions of our budget. Some unfair and
32

some inaccurate charges have been leveled against it. That is why

I am so very pleased today to have this opportunity to appear before you to discuss our detailed budget proposal. I am confident

that a review of the full details of our budget will demonstrate that

we are proposing a balanced responsible approach to building a

strong and healthy America.

The budget before you today keeps the promises the President

has made. It proposes new and innovative solutions for meeting the

challenges that face the nation. Our proposal increases support for

America’s children and families, enhances the ground breaking research being sponsored by the National Institutes of Health, and

I want to thank both senators for being so supportive of the NIH.

Again, the modernization of Medicare expands access to health

care and reforms the way the department operations are managed.

Mr. Chairman, the total HHS request for fiscal year 2002 is $468

billion. The discretionary component totals $55.5 billion, and the

amount before this committee totals $300 billion in budget authority, of which $52 billion is discretionary.

I know, Mr. Chairman, you have been very interested in NIH, as

I have. I want to tell you that there is just some wonderful things

going on up at NIH. And as you know, and you have been up there

several times, and we are so close in so many areas, it is truly an

exciting time to be Secretary of this Department and be involved.

Senator Harkin, I appreciate your support of CDC. I have been

down there. I do not know if you know this, but we are currently

renting 22 buildings all over the city of Atlanta. I went down there

and looked at it, and it is a crazy way to run it. We have land

there, we have got an opportunity to build something that everybody in America can be proud of. And I pushed very hard to get

the money of $150 million for new laboratories there. I would like

to consolidate the 22 areas into one beautiful college campus that

is going to do the things necessary for CDC, and I appreciate your

support.

Senator HARKIN. I will back you any way I can.

Secretary THOMPSON. I know that, and I appreciate that.

In regards to women’s health, we have put in a great deal of additional money for women’s health because it is so important. We

also have put a lot of money into children.

PREPARED STATEMENT

I could go on, but I think I would much rather stop at this time,

Senators, and Senator Murray, it is a pleasure to be in front of you

as well. I know you have lots of questions, and I would just as soon

answer your questions, and I will leave the rest of my written remarks for you to put in the record if that would be okay.

Senator SPECTER. That is fine, Mr. Secretary. We appreciate

that.

[The statement follows:]

PREPARED STATEMENT OF HON. TOMMY G. THOMPSON

Good Morning, Chairman Specter, Senator Harkin, and members of the Subcommittee. I am honored to appear before you today to discuss the President’s fiscal

year 2002 budget for the Department of Health and Human Services.

Several weeks ago, I appeared before your colleagues on the Senate Budget Committee to discuss the President’s fiscal year 2002 budget framework. Since that
33

time, much has been written and said about selected portions of our budget, and

some unfair and inaccurate charges have been leveled against it. This is why I am

so pleased to have the opportunity to appear here today to discuss our detailed

budget proposal. I am confident that a review of the full details of our budget—not

selected pieces of it—will demonstrate to one and all that we are proposing a balanced, responsible approach to building a strong and healthy America.

Part of this approach involves taking another look at the way we do things on

the national level. We must no longer be content to do things a certain way because

‘‘that’s how we’ve always done it’’; but must instead be willing to reform our business practices and seek innovative ways to manage our programs. And while we

know that the Federal Government has an important role to play, we must also recognize that we must look to others—to State, local, and tribal governments, to community and faith-based organizations, to the private sector, and to academic institutions—for new and creative approaches to solving public problems. The President

and I share this view, and I am proud to say that it is manifested in the budget

he has put forward.

The budget I present to you today keeps the promises the President has made and

proposes new and innovative solutions for meeting the challenges that face the nation. Our proposal increases support for America’s children and families; enhances

the groundbreaking research being sponsored by the National Institutes of Health

and protects public health; begins the modernization of Medicare and expands access to health care; and, invests in infrastructure and reforms the way the Department’s operations are managed. The HHS budget also reflects the President’s commitment to a balanced fiscal framework that puts discretionary spending on a more

reasonable and sustainable growth path; protects Social Security, Medicare, and

other priority programs; continues to pay down the national debt; and, provides tax

relief for all Americans.

Mr. Chairman, the total HHS request for fiscal year 2002 is $468.8 billion (out- lays). The discretionary component totals $55.5 billion (budget authority). The

amount before this Committee totals $300.7 billion in budget authority, of which

$51.4 billion is discretionary. Let me now discuss some of the highlights of the HHS

budget.

INCREASING SUPPORT FOR AMERICA’S CHILDREN AND FAMILIES

The HHS budget substantially increases our investment in children. Overall, the

President’s budget provides nearly $3 billion in increased spending for children’s

programs in this Department. The budget includes both increases for existing programs and investments in a number of new programs designed to fulfill President

Bush’s commitment to making sure that no child is left behind. This administration

recognizes that America’s children and families are its strength, and this budget reflects our commitment to helping them thrive and prosper. Our budget also increases support for the charitable organizations that can make such a difference in

people’s lives.

After School Certificates

One of the lessons I learned during my years as Governor of Wisconsin was that

for people to move from dependency to success in the workforce, you had to be willing to invest in programs that support working families. One of the most important

things that we as a government can do to help working families is to assist them

in obtaining high-quality child care. Last year the Congress voted to provide a substantial increase in child care funding, and this year we are asking you to take another step to help working parents and their children be successful. The President

has requested a total of $2.2 billion for the Child Care and Development Block

Grant and has proposed to specifically dedicate $400 million for After School Certificates within the block grant. These certificates would help low-income working parents to pay for the costs of after school care for up to 500,000 children who are less

than 19 years old. We expect these after school activities to also have a strong educational component, helping children to achieve success in school.

Promoting Safe and Stable Families and Independent Living

Our budget takes a number of steps to help protect our most vulnerable and atrisk children and to help them live safe and productive lives. First, we propose to

create a new $67 million discretionary program within the Promoting Safe and Stable Families program to mentor children of prisoners. This initiative will provide

grants through States, to assist faith and community-based groups in providing a

range of activities to assist children of prisoners and probationers, including familyrebuilding programs that will help to reunite children and parents once the parent

is released from prison if it is in the best interests of the child. Our budget also
34

proposes a $200 million increase in mandatory funding for the Promoting Safe and

Stable Families program, which supports State and Tribal child welfare agencies in

carrying out family preservation and support services and adoption promotion and

support programs. We also propose an additional $60 million for the Independent

Living program. These funds would be used to provide vouchers, worth up to $5,000,

to youths who are aging out of foster care so that they can obtain the education and

training they need to lead productive lives. Funds could be used to pay for either

college tuition or vocational training.

Maternity Group Homes

One of the toughest problems we face in trying to end the cycle of dependency

is children having children. These teenage mothers have often suffered abuse or neglect and may not have a safe and supportive family environment in which to raise

their babies. To begin removing the obstacles to success that these mothers and

their children face, we are proposing $33 million for a new Maternity Group Homes

program. This program will support efforts to work with organizations that operate

community-based, adult-supervised group homes for teenage mothers and their children, as well as to provide certificates to young mothers to obtain supportive services. These homes will provide a safe and nurturing environment for young mothers

while offering the support necessary to help them and their children to improve

their lives.

Promoting Responsible Fatherhood

Helping young mothers is an important part of our program to assist America’s

families, but it is also important that we recognize the critical role that fathers play

in the lives of their families. The unfortunate reality is that nearly 25 million children do not live with their fathers, and studies show that these children are far

more likely to experience poverty and suffer problems in school than children who

live with both parents. Our budget framework includes $64 million to begin an initiative to promote responsible fatherhood by providing competitive grants to faithbased and community-based organizations that work to strengthen the role that fathers play in their families’ lives. These funds will be used to support programs that

help low-income and unemployed fathers and their families to avoid dependence on

welfare, and to fund programs that promote successful parenting and marriage. Of

these funds, $4 million will be used for special projects of national significance.

Compassion and Charitable Giving

The President has been a leader in recognizing the important role that charitable

organizations play in delivering services to the public, and we are proposing a number of steps to increase Federal support for these groups. First, we are requesting

$89 million to establish a Compassion Capital Fund. Through public and private

partnerships, these resources will be used to provide start-up capital and operating

funds to qualified charitable organizations so that they can expand or emulate

model social services programs. Funds will also support research on ‘‘best practices’’

among charitable organizations. Our budget also includes $3 million to establish a

Center for Faith-Based and Community Initiatives in the Department in accordance

with the President’s recent Executive Order. Finally, we have included a proposal

to encourage States to provide tax credits for contributions to designated charities

that work to address poverty. Under this proposal, States would be allowed to use

Federal funds provided through the Temporary Assistance for Needy Families program to partially offset revenue losses that resulted from the tax credits.

Head Start

Head Start is the Nation’s largest early childhood education program. The Head

Start program helps to ensure that low-income children start school ready to learn

and, to that end, provides a range of comprehensive child development and health

services. The President proposes to revitalize Head Start by making school readiness skills such as pre-reading and numeracy the program’s top priorities. For fiscal

year 2002, the budget proposes a total of $6.3 billion for Head Start, an increase

of $125 million. These funds will allow Head Start to serve 916,000 children, including 55,000 in Early Head Start, and to maintain a competitive salary for teachers.

ENHANCING SCIENTIFIC AND HEALTH CARE QUALITY RESEARCH

Advances in scientific knowledge have provided the foundation for improvements

in public health and have led to enhanced health and quality of life for all Americans. Our fiscal year 2002 budget enhances support for scientific research as well

as for research to improve the quality of the Nation’s health care system.
35

Biomedical Research Sponsored by the National Institutes of Health

The National Institutes of Health (NIH) is the largest and most distinguished biomedical research organization in the world. The research that is conducted and supported by the NIH, from the most basic research on biological systems to the successful mapping of the human genome, offers the promise of breakthroughs in preventing and treating any number of diseases. A top priority for this Administration

is ensuring that the NIH continues to have the resources necessary to help turn

these promises into a reality.

This budget keeps the President’s commitment to double NIH’s fiscal year 1998

funding level by fiscal year 2003. For fiscal year 2002, we are proposing an increase

of $2.75 billion, which will be the largest dollar increase ever for NIH. This funding

level will enable NIH to support over 34,000 research project grants, the highest

level in the agency’s history. NIH will expand its focus on four research areas that

show the greatest potential for yielding new scientific breakthroughs: genetic medicine, clinical research, interdisciplinary research, and health disparities.

With any large increase in resources, there also comes the increased challenge of

making sure that those resources are managed properly. I take this responsibility

very seriously, and NIH will be working to develop strategies to ensure that we are

managing taxpayer dollars in the most efficient and effective way.

Patient Safety and Health Care Quality

The Agency for Healthcare Research and Quality (AHRQ) is the Federal agency

with primary responsibility for research on the Nation’s health care system and is

HHS’s lead agency for improving patient safety and the quality of everyday health

care. The fiscal year 2002 budget provides a total program level of $306 million for

AHRQ, an increase of $36 million or 13.5 percent over fiscal year 2001. AHRQ will devote a total of $53 million to continue the work this Committee first

funded in fiscal year 2001 to identify ways to reduce medical errors. These funds

will support activities to research the causes of medical errors, develop and test new

technologies to reduce medical errors, test reporting strategies, and improve training. Earlier this week, I announced the establishment of a new Patient Safety Task

Force within the Department in which AHRQ will collaborate with FDA, CDC, and

HCFA to improve existing reporting systems on patient safety. HHS seeks to develop a robust, anonymous database of information on errors and adverse events

that can be used to find new and better ways to improve patient safety. Our request includes a $26 million increase for research on health care quality

and cost-effectiveness. Like you and many others, we are reviewing the recent recommendations by the Institute of Medicine for research to improve the quality of

health care. Once that review is complete, I expect that an appropriate portion of

these resources will be directed toward the recommendations that we conclude

should be given the highest priority. I also expect the findings of this and other research on patient safety, which have emphasized the importance of encouraging and

rewarding the development of health care systems that encourage safer and higherquality care, to guide our efforts to improve Medicare, Medicaid, and other government health programs.

IMPROVING MEDICARE AND EXPANDING ACCESS TO QUALITY HEALTH CARE

Of all the issues confronting this Department, none has a more direct effect on

the well-being of our citizens than the quality of health care. Our budget proposes

to improve the health of the American people by taking important steps to improve

Medicare, including the addition of a prescription drug benefit, and by directing

funds to various initiatives aimed at expanding access to health care.

Modernizing Medicare

The Medicare program has been the center of our society’s commitment for ensuring that all of our seniors enjoy a healthy and secure retirement. Honoring this commitment means not only making sure that the program is financially prepared for

the wave of new beneficiaries that the aging of the baby-boom generation will bring,

but also ensuring that current beneficiaries have access to the highest quality care.

As an interim step, the President has put forward an Immediate Helping Hand

(IHH) prescription drug proposal. This proposal provides $46 billion over 5 years to

help States provide prescription drug coverage immediately to beneficiaries with

limited incomes or high drug expenses. This proposal, which will sunset in fiscal

year 2005 or as soon as legislation to strengthen Medicare including a prescription

drug benefit is enacted, would provide immediate coverage for up to 9.5 million

beneficiaries.

We also believe, along with many members of Congress who have supported and

continue to support bipartisan efforts to strengthen Medicare, that we must take
36

steps to improve Medicare as soon as possible. Inadequate prescription drug coverage is only the most obvious gap in Medicare benefits. Today, Medicare covers

only 53 percent of the average senior’s annual medical expenses, and the options

available to seniors to help them limit these expenditures are declining. In addition,

Medicare is facing a looming fiscal crisis. A full assessment of the health of both

the Part A and Part B Trust Funds reveals that spending exceeds the total of tax

receipts and premiums dedicated to Medicare and that financing gap is expected to

widen dramatically. Even without the financing problem, Medicare modernization

would be necessary to ensure beneficiaries get high quality health care. President

Bush proposes to devote $156 billion (including funding for Immediate Helping

Hand) over the next 10 years to a set of improvements in Medicare that are urgently needed. These Medicare modernizations include taking steps to make better

coverage options available, to assure that all seniors have affordable access to prescription drugs, to provide better options for high out-of-pocket expenses, particularly for low-income seniors, and to ensure that Medicare has greater overall financial security.

Expanding Community Health Centers

Our budget also proposes steps to strengthen the health care safety net for those

most in need. Community Health Centers provide high quality, community based

care to approximately 11 million patients, 4.4 million of whom are uninsured,

through a network of over 3,000 centers in rural and urban areas. The President

has proposed to expand and increase the number of health center sites by 1,200 by

fiscal year 2006, and to double the number of individuals without alternative coverage who are served by the centers. As a first installment of this multi-year initiative, we propose to increase funding for Community Health Centers by $124 million.

We will also be looking at ways to reform the National Health Service Corps so as

to better target placement of providers in areas experiencing the greatest shortages

of health professionals.

Increasing Access to Drug Treatment

The problems caused by substance abuse affect not only the physical and mental

condition of the individual, but also the well-being of society as a whole. Nationwide,

approximately 2.9 million people with serious substance abuse problems are not receiving the treatment they desperately need. To help close this treatment gap, we

propose to increase funding for substance abuse treatment by $100 million. Of these

funds, $60 million will be used to increase the Substance Abuse Block Grant, the

primary vehicle for funding State substance abuse efforts, and $40 million will go

to increase the number of Targeted Capacity Expansion grants, which seek to address the treatment gap by supporting strategic and rapid responses to emerging

areas of need, including grants to organizations that provide residential treatment

to teenagers.

Organ Donation

Our budget supports an initiative very close to my heart. Approximately 75,000

patients are awaiting organ transplants, far above the number of available donors.

In fact, organ transplants in 2000 totaled 22,827, an increase of 1,172 over the

21,655 transplants that occurred in 1999. The number of living donors rose from

4,747 in 1999 to 5,532 in 2000, an increase of 16.5 percent, the largest 1-year jump

ever recorded. While I am encouraged by the progress that has been made in the

last year, there is still a very long way to go. To tackle this problem, I launched

a new national initiative, on April 17th, to encourage and enable Americans to ‘‘Donate the Gift of Life’’. I am beginning a national ‘‘Workplace Partnership for Life’’,

in which employers, unions and other employee organizations can join in a nationwide network to promote donation. I released a model organ and tissue donor card,

incorporating proven elements from today’s donor cards and have ordered an immediate review of the potential of organ and tissue registries where donors’ wishes

could be recorded electronically and made available to families and hospitals when

needed. I have also made a pledge to create a national medal to honor the families

of organ donors and will create a model curriculum on donation for use in driver

education courses, to be offered to states and counties nationwide. And, let me tell

you, this is just the beginning. I intend to do everything I can to increase organ

donation throughout America and to create the most comprehensive effort ever in

our nation regarding donation and transplantation.

INVESTING IN INFRASTRUCTURE AND REFORMING MANAGEMENT

For any organization to succeed, it must never stop asking how it can do things

better, and I am committed to seeking new and innovative ways to improve the
37

management of our programs. But we must also recognize that we do a disservice

to all who rely on this Department if we do not provide the resources necessary to

effectively administer our programs. In preparing our budget, we began the process

of evaluating the programs and business practices of this Department and identifying the areas where we can do a better job of managing taxpayer resources, as

well as those areas where new investments are required if we are to successfully

administer our operations.

HCFA Management Reform

One of the most important management reforms we will pursue is the improvement of the Health Care Financing Administration (HCFA). I have often referred

to HCFA as the agency people love to hate; and I recognize that patients, providers,

and States have legitimate complaints about the scope and complexity of the regulations and paperwork that govern the Medicare, Medicaid, and State Children’s

Health Insurance programs. At the same time, we must recognize that in the last

few years HCFA has been tasked with implementing several pieces of major legislation and its responsibilities have grown more complex with each new major

healthcare law or budget reconciliation.

Concerns about HCFA’s management capabilities have been raised in several

General Accounting Office reports, including the High Risk Series: An Update (January 2001) and Financial Management: Billion in Improper Payments Continue to

Require Attention (October 2000). HCFA management reform is an Administration

priority. HCFA will undertake a major effort to modernize and streamline its operations to effectively manage current programs and implement new legislation. In

particular, HCFA’s role in a modernized Medicare program needs to be carefully

considered. This may require substantial changes in HCFA’s mission and structure.

My goal is to assure that HCFA’s resources are focused as effectively as possible

on improving quality and limiting costs for Medicare beneficiaries, limiting burden

for providers, and increasing efficiency for taxpayers.

The budget proposes an increase of $109 million, or 5 percent, for HCFA program

management. Included in the HCFA program management budget is an increase of

$36 million, for a total of $53 million, to support the development of the HCFA Integrated General Ledger Accounting System (HIGLAS). HCFA currently relies on several financial management systems to account for the hundreds of billions of dollars

spent on Medicare benefits, and most contractors do not use double entry accounting

methods or claims processing systems with general ledger capabilities. This system

requires financial statements to be imputed manually, increasing the risk of administrative and operational errors and misstatements. HIGLAS will provide a uniform

Medicare accounting system that will help to detect and collect money owed to the

Medicare Trust Funds, retain a clean opinion on financial statements without more

expensive, alternative efforts, and comply with financial management statutory requirements.

I am also committed to reforming HCFA’s antiquated and inefficient contracting

system. We are considering a number of options in this area including: allowing carriers who are not health insurance organizations to become Medicare contractors;

allowing the Secretary (as opposed to the Part A provider) to contract for and assign

fiscal intermediaries to perform claims processing, claims payment, communications,

audit functions, renewing contracts, and transferring functions; and replacing current special provisions for terminating contracts with more standard terms and conditions embodied in the Federal Acquisition Regulation (FAR). In addition, I am including in the budget $115 million in new proposed user fees for duplicate and

paper claims processing. We will work hard to enact these fees, which will help to

improve the efficiency and lower the cost of processing Medicare claims.

Revitalizing Laboratories and Scientific Facilities

It is critical that we invest in the modernization of the laboratories and scientific

facilities, for obsolete facilities affect our scientific readiness and compromise our

ability to retain the top scientists. Our budget includes funds to continue the revitalization of key facilities at the Centers for Disease Control and Prevention and the

National Institutes of Health. We are requesting $150 million for buildings and facilities at the Centers for Disease Control and Prevention, which will support construction of a laboratory facility dedicated to handling the most highly infectious

pathogens, such as Ebola, and construction of an Environmental Toxicology Lab.

The budget also requests $307 million for intramural buildings and facilities at the

National Institutes of Health to support projects such as the construction of the

John Edward Porter Neuroscience Research Center and a centralized, multi-level

animal facility.
38

Enhancing Coordination and Reducing Duplication of Operating Systems

The only way that this Department can effectively serve its many clients is if we

commit to making the necessary investments in our management and infrastructure. One of the challenges in a large, decentralized Department such as HHS is

finding ways to bring together diverse activities and to develop coordinated systems

for managing our programs. Our budget provides the resources necessary to begin

the process of streamlining our financial management and information technology

systems so that we can enhance coordination across the Department and eliminate

unnecessary and duplicate systems.

For financial management, we propose to invest $50 million, which includes funding for the new HCFA accounting system, to move toward a unified financial accounting system. The Office of Inspector General has cited problems with the Department’s current system structure, which involves five separate accounting systems operated by multiple agencies. We plan to replace these antiquated systems

with unified financial management systems that will increase standardization, reduce security risks, allow HHS to produce timely and reliable financial information

needed for management decision-making, and provide accountability to our external

customers.

In the information technology arena, we are proposing $30 million for a new Information Technology Security and Innovation fund. Currently, the Department’s information technology systems are highly decentralized, heterogeneous, and vulnerable

to exploitation. Funds would be used to implement an Enterprise Infrastructure

Management approach across the Department that would minimize our

vulnerabilities and maximize our cost savings and ability to share information. With

this approach, we will be able to reduce duplication of equipment and services and

be better able to secure our systems against viruses and network intrusion.

As the largest grant-making agency in the Federal Government, this Department

will also continue to play a lead role in the government-wide effort to streamline,

simplify, and provide electronic options for the grants management processes. As

part of the Federal Grant Streamlining Program, we will work with our colleagues

across the government to identify unnecessary redundancies and duplication in the

more than 600 Federal grant programs and to implement electronic options for all

grant recipients who would prefer to apply for, receive, and close out their Federal

grant electronically.

Redirecting Resources and Enhancing Flexibility

Being a wise steward of taxpayer resources means not only recognizing where you

need to invest but also where resources can be redeployed to more effective uses.

In preparing our budget, we carefully reviewed each agency, identified areas where

funding could be redirected, and made targeted reductions in selected programs. The

fiscal year 2002 budget eliminates $475 million in earmarked projects and $155 million in funding for activities that were funded for the first time in fiscal year 2001.

In addition, the budget shifts $597 million from programs that are duplicative, or

whose goals are better met through other avenues, to higher priority activities. And,

to assist in financing other high priority activities, the budget expands the use of

Public Health Service Evaluation funds. These decisions helped to meet our goal of

moderating the large increases in discretionary spending that have occurred over

the last few years and putting the budget on a more sustainable growth path for

the future.

This Administration is also committed to giving States greater flexibility to manage public health grant programs. Our budget proposes to give States expanded authority to transfer funds among public health grants, thereby enabling them to

make more efficient and effective use of Federal resources and to target and reallocate funds to public health priorities identified at the State and local levels.

In addition to giving the States greater flexibility, I am seeking to increase my

transfer authority from one percent to six percent, to eliminate the restriction that

the transfer may not increase an appropriation by more than three percent, and to

make it Department-wide. I believe this transfer authority is a valuable tool for

managing the Department’s resources and will allow me to respond to emergency

needs or unforeseen events that would otherwise adversely effect a program or agency.

Continuously Evaluating and Improving Program Performance

The Government Performance and Results Act serves as an important tool for

making sure that this Department is not only doing the right things but that we

are doing them well. As in previous years, our budget request is accompanied by

the annual performance plans and reports. The performance measures and targets
39

in these reports touch nearly every aspect of the Department’s multi-faceted mission

and detail a number of notable achievements, including:

—HCFA met its fiscal year 2000 target of reducing the Medicare error rate to 7

percent. Auditors estimated improper payments at $11.9 billion, compared with $13.5

billion in fiscal year 1999. The error rate has fallen to roughly half of what it

was in fiscal year 1996, and HCFA is pursuing increasingly rigorous goals for

fiscal year 2001 and fiscal year 2002.

—The Administration for Children and Families (ACF) reported that 42.9 percent

of adult recipients of TANF became employed in fiscal year 1999. This is a primary indicator of success in moving families toward self-sufficiency. It improves

on the fiscal year 1998 baseline of 38.7 percent and exceeds the target of 42

percent.

—CDC reported a reduction of perinatal Group B streptococcal disease—the most

common cause of severe infections in newborns—by 70 percent from 1995 to

1999, exceeding the goal.

These are just a few of the dozens of impressive success stories found in the 13

performance plans and reports. GPRA has been and will continue to be an important part of our effort to improve the management and performance of our programs.

WORKING TOGETHER TO BUILD A STRONG AND HEALTHY AMERICA

Mr. Chairman, the budget I bring before you today contains many different proposals; but, the common thread that binds them all together is the desire to build

a strong and healthy America and to improve the lives of the American people. All

of our proposals, from enhancing scientific research to modernizing Medicare, from

expanding access to care to increasing support for the Nation’s children and families, are put forward with these simple goals in mind. I know these are goals we

all share.

As you begin to consider our proposals, let me leave you with one final thought.

Senator Everett Dirksen said of the legislative process: ‘‘You start from the broad

premise that all of us have a common duty to the country to perform. Legislation

is always the art of the possible. You could, of course, follow a course of solid opposition, of stalemate, but that is not in the interest of the country.’’ Starting from this

premise, I am prepared to work with each of you to ensure that we develop a budget

for this Department that effectively serves the national interest. I would be happy

to address any questions you may have.

CENTERS FOR DISEASE CONTROL PREVENTION

Senator SPECTER. As is our practice, we will commence with 5-

minute rounds for each Senator.

I begin, Mr. Secretary, with the issue of the Centers for Disease

Control. The Centers have deteriorated just tremendously, and it

is a matter of some concern to me that there had not been action

by the last administration and a very competent Secretary of

Health and Human Services in alerting this subcommittee to the

deplorable conditions. I made a trip down there about a year ago,

and this subcommittee took the lead in putting in $170 million because the situation was so catastrophic.

My recent meeting with the representatives of the Center found

that they want $240 million. You have——

Secretary THOMPSON. $150 million.

Senator SPECTER [continuing]. $150 million, which is $25 million

down from our figure last year. And my question to you is, how do

you calculate $150 million, and is that really enough, or are the

people at the Center really on the right track in asking for about

$240 million?

Secretary THOMPSON. Well, I think you can make that argument,

Senator, but the truth of the matter is, there are 22 buildings that

we’re renting, and I think it makes very good fiscal sense as well

as scientific sense to be able to consolidate those into one campus.
40

Senator SPECTER. I went down there, and there is no doubt about

the consolidation. Let me ask you to do this. Let me ask you to

have your department take a look at the overall program, which is

a big one, in excess of a billion dollars as I understand it, and give

us a projection as to what we are going to have to spend next year,

the year after, so that we can make an evaluation of priorities as

to whether we think we need to shift some money.

Secretary THOMPSON. Okay. Well, Senator, I have already done that, and that is why we put in $150 million. It is going to have

to be an ongoing $150 million in order to modernize and do it correct. If you want to accelerate it, you could do it at $175 million.

We cut back on some planning for the next building and we felt we

could do that in the next fiscal year, and we put some labs and so

on in this year.

Senator SPECTER. Let us take a look at your specific projections

and compare that with what the Center has in mind.

Secretary THOMPSON. Fine.

Senator SPECTER. And with what the other advocates have in

mind.

Secretary THOMPSON. My projections are not much different than

the Center’s.

Senator SPECTER. Well, the figures are a fair amount lower, but

let us take a look at the specifics.

Secretary THOMPSON. Absolutely.

STEM CELL RESEARCH

Senator SPECTER. There is not a whole lot of time, so let me

move to the issue of stem cells, which is a very important topic,

and note just very briefly for the record that when this issue broke

in November of 1998, this subcommittee had a hearing within a

couple of weeks. We have had seven hearings on the subject and

I think it is a fair assessment that the subcommittee, I know that

Senator Harkin and I are convinced that the stem cells which come

from embryos are vital for medical research.

A point which I think has to be emphasized, and you and I have

talked about this informally but just a word or two on the record,

is that these embryos are created for in vitro fertilization, there are

more created than necessary, and they are going to be discarded.

If there were any possibility that these embryos would turn into

human life, I would be the last to countenance using them for stem

cells. But when they are going to be destroyed, then the alternative

is to use them or lose them, in effect.

I know that there is another evaluation of the legal opinion

issued by general counsel for the Department of Health and

Human Services, which concluded that Federal funds may be used

for research on the stem cells, once they are extracted, but Federal

funds may not be used to extract the stem cells from the embryos.

And speaking as one lawyer to another, lawyers’ opinions are not

too hard to obtain on any given proposition.

My yellow light is up and so I will conclude the issue by asking

you for your perspective and what your plans are on handling this

stem cell matter.

Secretary THOMPSON. Thank you very much, Senator. You know

this is a very contentious issue and one in which I have been very
41

much involved in from my prior life as the Governor of the State

of Wisconsin.

Stem cells are being evaluated by the Department, both by the

general counsel, and other legal opinions are being discussed, but

also scientific review is being done by NIH. Both of those reviews

will be to me, hopefully, by the first week in June. And as regards

to the process that is already in place, there are two applications,

and those applications are being reviewed, even if the hearing was

not postponed in April, they would not have been able to be funded

until next April. That still is possible, if in fact both reviews come

back consistent with your point of view, or if in fact Congress decides to change the law, Senator.

Senator SPECTER. My red light is on, so we turn now to Senator

Harkin.

REGULATION OF TOBACCO BY FDA

Senator HARKIN. Thank you very much, Mr. Chairman.

Mr. Secretary, I have been pleased to hear your comments about

the need for FDA to regulate tobacco. Stick with it.

Secretary THOMPSON. I notice when I looked around, there were

not too many people behind me, except you, Senator.

Senator HARKIN. Well, stay out there, you are right on that issue

and you are going to get a lot of support because people are on your

side on this issue.

The tobacco companies, for example, you know that nitrosamines

for example, are highly carcinogenic. They have the technology to

reduce that, they are not doing that. That is one of the things that

FDA could do. But, I just want to say that, you know, we had—

the FDA issued in 1996 these regulations, and the Supreme Court

said they didn’t have the legislative authority with which to do

that.

But they said, the tobacco companies said they were going to voluntarily not market to kids, that they were going to not do that.

Well, they have been saying that for a long time. A recent Federal

Trade Commission report showed that in the first year after the

settlement, tobacco marketing expenditures went up 22 percent to

a record $8.24 billion per year, and much of the increase was in

marketing efforts that reached kids. Two for one discounts that reduced cigarette prices, payments to stores for high visibility shelf

displays, et cetera.

So I tell you, I personally believe the FDA needs to have the ability to rein in the industry and protect our kids. That is what FDA

is supposed to do, supposed to protect us are from unwarranted

drugs, unsafe foods, and cigarettes.

The regulations that FDA issued included a number of restrictions, including banning of outdoor advertising within a thousand

feet of schools, it would have allowed only black and white text appearing in publications with youth readership.

TOBACCO ADVERTISEMENTS

Senator HARKIN. I am going to ask Sabrina to hold this up. This

was in Cosmopolitan. 1,463,000 teenagers, they say mostly girls

read it, and that is the ad for Virginia Slims, and that is what

these young girls are reading. There is no question in my mind now
42

why lung cancer now has overtaken breast cancer as the most pervasive cause of death among women in America today.

Secretary THOMPSON. Very true.

Senator HARKIN. It is true. And we are finding out more and

more that the tobacco companies have been targeting women and

young girls, getting them hooked young.

Well, I do not know that I have so much of a question, except

just to say, Mr. Secretary, I urge you to continue your efforts, and

I do not mean to put you on the spot or anything like that, but I

just want to know how you feel about the FDA having that kind

of authority to restrict this kind of advertising, to restrict where

they can put tobacco on store shelves, all the things that were in

the regulations that FDA issued in 1996 which the Supreme Court

took out, and which I hope we in Congress are going to address.

Secretary THOMPSON. This is a big issue, Senator Harkin, for me

and obviously for you, and I appreciate that. It is amazing that

165,000 women died last year which was directly caused by tobacco

smoking, and 30 percent of our teenagers in high school have tried

cigarettes—32 percent of our teenagers have tried a cigarette or tobacco in the last 30 days.

Senator HARKIN. How many?

Secretary THOMPSON. Thirty two percent. And the record shows

that if in fact you are able to prevent teenagers from smoking, that

there is an 80 percent chance that people will not smoke after they

reach age 21. So it is obvious that we have to address this problem.

In regards to regulation, really it is going to be up to Congress

if they can pass the bill. FDA should have some regulation, should

be able to do it, and I would welcome that opportunity, Senator.

Senator HARKIN. I appreciate your forthright statement.

Secretary THOMPSON. Thank you.

Senator HARKIN. My yellow light is on too. I have one question

about Medicaid and managed care for disabled, but I guess I will

have to wait for my second round.

Senator SPECTER. Senator Murray.

Senator MURRAY. Thank you very much, Mr. Chairman, and

thank you, Mr. Secretary.

Secretary THOMPSON. How are you, Senator?

Senator MURRAY. I am doing great. Good to see you here at our

committee, and I look forward to working with you on this very

very important piece of our budget.

I have a first question today about the nursing shortage, and I

think everyone of us have heard——

Secretary THOMPSON. It is a real problem.

NURSING SHORTAGE

Senator MURRAY. There is a real shortage, I am very concerned

about it, and I see that the President proposed to redirect health

profession funds from physician education to professions like nursing, which is one step, but in talking to a number of our technical

schools and community colleges that do a lot of the initial training

on this, they are telling me that the impact has come from welfare

reform, which has changed the emphasis and only gives 1 year

credit for education, so that there is not an incentive for women

and men on welfare to go into nursing, because they don’t get the
43

exemption long enough to get the training that they need. I think

it is really important to have some flexibility in the welfare program to provide that education and training, and I just wanted to

find out if you would support extending that current 12-month education work standard in order to meet the growing nursing needs

in our hospitals and nursing homes.

Secretary THOMPSON. If I could just broaden the question a little

bit, I would appreciate it, Senator Murray. Nursing shortage is a

severe problem in America and it is going to get worse, especially

for the nursing home industry.

Currently, we are 90,000 short for registered nurses, 250,000

short on CDNs, and it is very important that we address it, and

I applaud you for your leadership. It is also a big concern of mine

and the Department so we want to do something about it.

In regards to welfare reform, TANF is not going to be reauthorized until next year, and I will be more than happy to work with

you to find ways on how we can encourage it, but I do not think

welfare reform is the cause for the nursing shortage. The nursing

shortage is caused by long hours and shortage, in the fact that the

working conditions have not been the best for nurses. What we

have to do as a Congress, and as an administration, we have to

look at ways to encourage that.

I think we also have to consider the possibility, and I know this

is not popular, but you are asking my opinion, so I think we are

also going to have to look at seeing how we might be able to encourage immigration avenues to encourage people that want to

come to the United States to go into the health professions.

I am very concerned about the future of nursing home industries

unless we get more CNAs. Projections are that the CNA shortage

is going to go from 250,000 possibility up to 400,000 in the near

future and that’s going to be a very serious problem for you, for me,

and for America.

Senator MURRAY. Well, I really appreciate the fact that you understand this and I want to work with you on this.

Secretary THOMPSON. I really want to work with you too. It is an

issue that is very near and dear to me.

Senator MURRAY. I agree that wages, long hours is a contributing

factor, but in talking to many of the facilities in my home State

that train and educate, particularly women obviously, into these

professions, there are not women applying, and one of the——

Secretary THOMPSON. They are not, and we have to encourage

people to do that.

Senator MURRAY. And I think one way to encourage that and

help promote that would be to extend that education work standard

for 2 years specifically for a nursing program.

Secretary THOMPSON. I would be more than happy to work with

you on that, and I am very supportive of issues like that, and how

we can encourage more young people to go into the nursing profession.

CHILD CARE

Senator MURRAY. Very good, okay.

Another quick question. In the President’s budget he increases

funds for child care for older children, which I am pleased to see,
44

but I also notice that he cuts Federal support for child care for

younger children by $200 million, which seems to go against the

welfare reform standards that have been advocated, which require

that even women with young children need to be in the work force

earning wages. Was there a study that showed that there was a

drop in the national needs for child care for younger children?

Secretary THOMPSON. No, but I have to dispute your conclusion.

I do not want to be in a position of being confrontational, but the

baseline was $2 billion, and the discretionary money. We are putting in 200 million more, or a 10 percent increase, to $2.2 billion

for child care in the discretionary fund. And out of that discretionary fund of $2.2 billion, the President says instead of just having a block grant going back to the State, he wants to earmark

$400 million of that $2.2 billion, or the 10 percent increase plus the

additional $200 million, to allow for children between the ages of

13 and 19 to be able to have after school care. He thinks it is a

real serious problem. Instead of a cut, it is going to allow for

500,000 additional students to be taken care of under the program.

The second thing is, there also is the mandatory side of child care, and that is a $150 million increase. So instead of a cut, there

has been a $350 increase in child care, a 10 percent, and a total

of $4.9 billion totally, and that is $350 million over what it was last

fiscal year 2001.

Senator MURRAY. Thank you for that, and I know my time is up.

I do want to talk to you at some point about the SCHIP program.

SCHIP

Secretary THOMPSON. Sure, I would love to talk about it.

Senator MURRAY. My question is one that is penalized for where

we have gone with that, and I would like to talk to you about some

flexibility in that program so my state and others that have been

trying to do the right thing are able to fall into that program.

Secretary THOMPSON. Your Governor, I think, has been in to see

me on it.

Senator MURRAY. Good, thank you.

Senator SPECTER. Thank you, Senator Murray. Senator

Landrieu.

HEALTH CARE

Senator LANDRIEU. Thank you. And Mr. Chairman, this is my

first meeting and I want to tell you how pleased I am to be on the

committee and to serve with our ranking member and my wonderful friend and colleague, and Mr. Secretary, it is a pleasure to be

with you this morning.

Secretary THOMPSON. Thank you, Mrs. Landrieu.

Senator LANDRIEU. Let me follow up on what Senator Murray

was highlighting and just associate myself with her remarks, because the issue of health care and child health and the nursing

shortage is on everyone’s mind and really is at the heart of our efforts to deliver a quality health care system for this nation.

Secretary THOMPSON. Absolutely.

Senator LANDRIEU. I mean, without nurses it cannot be done,

with all due respect to doctors and the other health

professionals——
45

Secretary THOMPSON. You are absolutely correct.

Senator LANDRIEU [continuing]. That nurses are really the heart

of that whole enterprise, and we have a real, I would almost say

crisis in this Nation regarding that, and it is going to take a bipartisan sort of multifaceted effort to try to come up with some immediate solutions.

But, I want to follow up on this additional child care piece that

Senator Murray brought out, because I was looking at the numbers

too, and want to work with you to increase our investment in child

care, recognizing that the current budget underserves millions and

millions of communities. And without the child care dollars, particularly for young children, but of course as you mentioned, there

are needs for children of all ages after school, targeted to those

communities of working families where both spouses are usually

having to work not one job but two jobs, child care becomes essential to that family being able to work their way out of poverty, and

to build the wealth and assets necessary to provide for their children.

So if the Government fails to meet them halfway on this issue,

we are really not living up to, I would say, the minimum that we

should do. And I wanted just to point out that the way we have

added the numbers, it does seem like there is a cut in this area

as opposed to a real increase, because although you are increasing

the overall number, you are earmarking a certain percentage for

older children, and the only place it can come is from the younger

children’s discretionary portion.

So, I do not want to argue those numbers this morning, but just

to say that I would like to try to get some clarification at a later

date if that is not the case, then, because it seems to us that that

most certainly is the case.

The second point is the area of foster care and stable families.

I want to work with you on that.

Secretary THOMPSON. So do I.

FOSTER CARE

Senator LANDRIEU. Because as you know, governments do a lot

of things well, but one thing we do not do very well is raise children, and children are best raised in families, in permanent stable

relationships with either one responsible caring adult, preferably

two parents, but one responsible adult can and in many instances

do beautiful jobs. So we need to try to support children in the biological families to which they are born but if that cannot take

place, to try then to find them a real family, not an orphanage, not

an institution, not a group home, but a real family.

And so I would just say that throughout the budget, I am going

to be focused on all of the programs that encourage reunification

where possible, but then a permanency for children to be placed

into a family. So with your prisoners initiative, I just wanted to ask

and make a point that we want to make sure some of these children can be reunited with parents who spent long time in prison,

but if it is not possible for the reuniting, that we should really

work to provide another home for children and not take that opportunity away from them to have a family.
46

I just want to raise that and look forward to working with you

on adoption and foster care issues particularly.

Secretary THOMPSON. You have raised several things and I would

like to respond to all of them, if I might, Senator Landrieu.

NURSING SHORTAGE

It is really heartening for me to hear, both from you and Senator

Murray, about your passion for increasing nursing. It is something,

we really have a problem facing us as a country, and if we are

going to have a quality health care, we are going to have to find

ways to increase the number of people applying for nursing school.

I do not know how much more I can tell you than I want to work

with you.

It is a very important thing for the department because with all

the additional rules and regulations we are imposing upon nursing

homes for more nursing care, and we do not have the nurses to

staff it, we are going to cause severe problems to that industry as

well as taking care of our elderly citizens, our mothers and our fathers, so it is a problem we have to take care of.

CHILD CARE

In regards to the dollars, there is a block grant of $2 billion in

discretionary funds for fiscal year 2001. We put an additional $200

million, which is a 10 percent increase; it goes from $2 billion to

$2.2 billion.

Now we earmarked $400 million for after school children, because we found, and I found as a governor that we could not use

this money to take care of a real serious problem. And those are

the freshmen and sophomores, and juniors, seniors could care less,

but they should be taken care of as well, but they were not as interested. But the boys and girls schools, the clubs, the opportunities to have athletic programs and educational programs after

school is so important. And that’s why the President felt that this

was something really needed.

So there is a 10 percent increase in it, but $400 million has been

earmarked, there is no question about that, I am not trying to hide

that. So, I mean, it is a block grant.

Then on top of that, we added an additional $150 million on the

mandatory side for child care. You are talking to somebody, you

know, when I was a Governor, I went from $12 million to $300 million my last year for child care. And I have told this Senate and

I have told the House many times when I was a governor, if you

are going to have welfare reform, you have to take care of the children, you have to be able to have child care. We did not have any

waiting lists when I left as governor in the state of Wisconsin.

Senator LANDRIEU. You did an excellent job.

Secretary THOMPSON. And so that is a passion of mine, and I

want to work with you in the reauthorization of TANF on that, but

I really think the figures speak for themselves. There is an increase of $350 million for child care, and there is an attachment,

that the money goes for that, but it actually takes care of 500,000

additional children.
47

FOSTER CARE

In regards to foster care and adoption, all I can say is I agree

with you. I mean, we need to do it. But the President has also recognized that the fathers are very important. That is why we have

a fatherhood initiative, and you know that. We have to have fathers being reintegrated back into the family, and that is why we

put an additional, a new program, $67 million, for fathers to come

back in, also $64 million for prisoners to be reintegrated. And prisoners are going to get out of jail, and we want them somehow to

have the skills necessary to be reintegrated back into that family.

And so those are two new programs that I think and hope that

you would support.

Senator LANDRIEU. Well, I know my red light is on, but let me

just say that you have been really one of the leaders in this area,

and I want to applaud you. If our Federal budget would reflect the

kind of priorities and investments that you made as Governor, we

would be a heck of a lot better off in this nation, so God bless you

and thank you for all your good work.

Secretary THOMPSON. Thank you, ma’am.

YOUTH VIOLENCE

Senator SPECTER. Mr. Secretary, moving to a number of other

subjects, this subcommittee took the lead 2 years ago in allocating

almost a billion dollars to the subject of youth violence from existing programs, and we did it in not a low key way, but a no key

way, just had working sessions with the three Departments for

which we provide appropriations, yours, Labor, and Education, and

also the Department of Justice was involved.

I call this program to your attention specifically, although I know

you’re aware of it. The administration’s funding reduced the programs which we have designated here by more than $250 million.

I had called Miss Margaret Lamontaine, the domestic counselor,

and I mention it at this time for the purpose of asking for your

staff review and your review with a view to implementing this program. It has a lot of facets and what we really need to do is to see

that these monies are being well spent in the areas to which they

are directed, and we will be following up with you.

Secretary THOMPSON. I appreciate that, Senator. As a new Secretary that has been here for 75 days, how can we interact with

your office better to develop a coordinated effort in regards to this

thing? How can we use your abilities and intellect in this, Senator

Specter, as a prosecutor and as a Senator, to do something in the

area of youth values and to make sure that the dollars are being

well spent to accomplish what you and the other Members of Congress have rightly set up?

Senator SPECTER. Mr. Secretary, I believe that we ought to do it

at the highest level with our chiefs of staff and Bettilou Taylor,

who is my key executive on the subcommittee, and who is very very

experienced, and have a monitoring program. We have to include

the domestic advisor to the President, Miss Lamontaine, and what

I think we really ought to do is have the three Secretaries and Senator Harkin and myself sit down, and perhaps invite the Attorney

General, because the Department of Justice is involved, and really
48

give it that kind of high level treatment. Because as you well know,

when youth violence breaks, then everybody is aghast, and we have

not——

Secretary THOMPSON. We have not had a coordinated effort.

Senator SPECTER. There is, as I say, no publicity, it is very quiet,

with working sessions, but the way to carry forward would be at

the top level and devise monitoring programs with very high ranking people in our offices.

Secretary THOMPSON. Could you call a meeting such as that?

Senator SPECTER. I will. I want to work through, as I say, Miss

Lamontaine to get the White House involved in it.

Secretary THOMPSON. Fine.

FAITH-BASED INITIATIVES

Senator SPECTER. Because there is going to have to be a fair

amount of their oversight and supervision on it ultimately.

With respect to the faith-based initiatives, Mr. Secretary, with some $89 million for the compassion capital fund in your department, $67 million for supporting children of prisoners and $64 million to promote responsible fatherhood, how do we carry these programs forward respecting the important separation of church and

state?

Secretary THOMPSON. We just have to be very diligent, we have

to make sure that our programs are set up in such a way that they

will not violate the Constitution, and that we have to monitor them

on a regular basis to make sure that that doesn’t happen. I think

Head Start is a prime example. I do not think many people realize

this, but almost two-thirds of the funds in Head Start go into faith

based organizations, and they do a wonderful job and I do not

think there has been any criticism of the Head Start program of

money going into faith based organizations. I use that only as an

example of one that really is working, and that is the kind of model

that I think we should probably try to emulate.

Senator SPECTER. Do you anticipate issuing any regulations to

establish the guidelines?

Secretary THOMPSON. Absolutely, sir.

ALTERNATIVE MEDICINES

Senator SPECTER. All right. We will look forward to seeing those.

On the subject of alternative medicine, that is a matter where

Senator Harkin and I have been keenly interested and have had

a number of hearings on over the course of the past decade. The

funding has been increased from $7 million to about $100 million,

and I would like to call your attention this morning to a specific

program by Dr. Herbert Benson, who is the president of the Mind

Body Medical Institute. He has developed some really remarkable

research on the benefits of releasing stress through medication and

other approaches, and the impact on children.

The red light is on, so I will conclude my portion now by just saying that I am going to be sending over some material to you from

Dr. Benson because I think this is worthy of consideration at your

level.

Secretary THOMPSON. Fine, thank you. I will be looking forward

to receiving it and reading it.
49

Senator SPECTER. Good. Senator Harkin.

Senator HARKIN. Thank you, Mr. Chairman. I ask a point of personal privilege to ask a question that Senator Byrd wanted to ask,

and not be deducted from my time.

Senator SPECTER. Certainly.

Senator HARKIN. Senator Byrd apologizes that he could not be

here, but he wanted me to ask this question, Mr. Secretary.

Secretary THOMPSON. Yes.

OBESITY RATES

Senator HARKIN. Why at a time when obesity rates are skyrocketing to the point that two-thirds of adults and a quarter of

children are overweight or obese, is the administration cutting

funding to the Centers for Disease Control and Prevention’s nutrition, physical activity and obesity program by 10 percent, when you

should be expanding the program, and what specifically does the

administration plan to do to help reduce obesity rates among

adults and children?

Secretary THOMPSON. I wish I had an answer to that, and I really do not. It is a problem facing America but it is also a problem

facing the whole world. People down at CDC, I went down there

to talk to them about diabetes, which is a growing problem, skyrocketing. And the people at CDC tell me, Senator, that 75 to 80

percent of the diabetic conditions can be challenged or changed by

two things, watching our diet and exercising.

And I am going to make prevention a real cause for the Department of Health and Human Services, and we are already putting

in place and I hope you pass that on to Senator Byrd, and people

tell me that diabetes impacts on the Medicare budget by about 4.9

percent. And I do not know if that is correct, and I do not know

of the 75 to 80 percent, those were the figures given to me, I think

they are both very high, but even if they are close, what we could

do for health care, health budgets, and improved quality of life by

doing this is something that I want to address.

Now I did not get involved in the budget until very late, and prevention is a cause that I want to pursue, and I am not going to

make any other apologies other than I think we have to address

it, we have to address obesity because it is a growing concern in

America, and I think the Department of Health should be the real

model of trying to change that and improve it, and I would solicit

your help and that of Senator Byrd in accomplishing that, and

hopefully we can.

Finally, I would like to say that the Department is going to do

everything possible to put in an initiative, hopefully with the cochairmen, Senator Specter and you, Senator Harkin, on this sometime this year. We have no ideas yet, but we are working on it, and

we would like to come to you after we bring something together

and talk to you about it.

Senator SPECTER. Senator Harkin, I think Senator Byrd’s time is

up.

Senator HARKIN. I am going to take off on that now with my

time. But Mr. Secretary, one thing I suggest, or I hope that you

will work with us on, putting on another hat, I am also ranking

on the Agriculture Committee of Senator Lugar.
50

Secretary THOMPSON. Yes, sir.

NUTRITION PROGRAMS

Senator HARKIN. Our farm bill is up next year. One big part of

that is the nutrition program, school lunch, school breakfast, all

the feeding programs. And quite frankly, we have to do something

about our school lunch programs out there. These kids are getting

too much fat in their diets, and the difference between that and the

school breakfast program is like night and day.

Secretary THOMPSON. I think we need to add more milk, cheese,

and corn.

Senator HARKIN. Skim milk, low fat cheese, and Soy, do not forget Soy, you have to get Soy in there, healthy for the heart and

all that.

Also the vending machines problems that we have in schools,

things like that. Now that may be out of your purview, but you are

a leader in this area, and I thought we had it fixed before about

keeping the vending machines off until after the last meal is served

in school, but we have to address that problem too, so I hope we

can work with you in sort of a cross-track on this with the Agriculture Department on this too in the feeding and the food programs, but I didn’t mean to go off on that.

Secretary THOMPSON. No, no, I appreciate it. I think it is something we should do.

Senator HARKIN. We should work together on that.

Secretary THOMPSON. Absolutely. I do not think there is enough

cooperation in the Federal Government in regards to this thing,

and I would like to see what I can do as a leader.

Senator HARKIN. That is one area where you and Ann Veneman

could really work together on that nutrition program.

Secretary THOMPSON. Appreciate that.

MEDICAID PROGRAM

Senator HARKIN. In 1997 Congress made changes to the Medicaid

program allowing States to mandate that Medicaid beneficiaries be

enrolled in managed care plans, and they included people with disabilities. But we also required that there is a basic set of protections. As a result, HCFA issued guidelines and the guidelines went

out, they are critical, especially for people with disabilities, to get

the quality of care that they deserve. These regulations lay out

standards, continuity of care, all that kind of stuff. In February,

the administration announced the delay of this regulation.

I know it was caught up in all these things they delayed. I do

not know about the other ones, but on this one I think it is unwarranted. President Bush has called for a patient’s bill of rights for

those who have private health insurance. How about the Medicaid

people that are being put into the managed care plans, especially

those people with disabilities, and I just hope that you will push

to get this regulation out and get the delay off. I think it was just

caught up in all those, but I am asking you to look at it.

Secretary THOMPSON. I appreciate that, and I will. I will look at

it before the end of the week and get back to you, Senator.

Senator HARKIN. I would really appreciate that very much.
51

Lastly, on restraints. We have all these studies that show that

a lot of adults and children with disabilities have died as a result

of restraints, there have been lots of stories on it. We just had recently two deaths in Iowa of young people being restrained, and

these are now being investigated of course, but there are some regulations, again regulations that were supposed to have come out,

to provide guidelines for the appropriate use of restraints in Medicaid funded facilities. They were supposed to be effective by March

23, and they are not there yet. The regulations were going to prevent the types of deaths that I just described, the two that just

happened in Iowa.

The GAO in September 1999 reported on restraint and seclusion

and found conclusively that children are especially vulnerable to

this unsafe practice. What is done, it is being used a lot of times

just as a means of the caretakers in those facilities, if some kids

act up and they do not have time to take care of it, put them in

restraints, and it is used as punishment a lot of times too, and

those regulations would address that.

And again, second, I hope you take a look at it and see why they

are not getting out there.

Secretary THOMPSON. You know, there was an order put out that

all these rules and regulations were going to be delayed for 60 days

and the one on Medicaid is all wrapped up in the 60-day review

period, Senator.

Senator HARKIN. Have all these people that work for you take a

look at them.

Secretary THOMPSON. I will, thank you.

Senator HARKIN. Thank you, Mr. Secretary.

FAMILY PLANNING

Senator SPECTER. Mr. Secretary, one final subject, and that is

the issue of family planning, birth control, and abstinence only education. This subcommittee has taken the lead in appropriating

funds in the past for abstinence only education. The controversy exists that to talk about abstinence only is unrealistic, because facts

of life being what they are, unless birth control devices are provided simultaneously, that the abstinence education will not work.

My own view has been that there is room in our budget, room

in our society, for both efforts, family planning with their approach,

which may include birth control as they protect their programs, but

separate programs for abstinence only education, where a large

part of our society which feels so strongly that birth control ought

not be made available, and ought to have an opportunity with abstinence only education to see if that will provide an answer.

Obviously, this is one of the most contentious issues facing our

society with all the ramifications that come from these issues, and

I would be interested, the subcommittee would be interested, to

know what the administrations plans and your Departments’ plans

are on family planning and abstinence only education.

Secretary THOMPSON. The President has taken a very strong position that they should be treated equally, and currently there is

an underfunding on the abstinence side, about $93 million compared to $135 million on the birth control side. And there is a

movement afoot to evaluate our programs to try and make them
52

equal, and this is something that the President feels very strong

about, Senator, and we are working on that.

Senator SPECTER. Mr. Secretary, that is a fair amount of ground,

that cannot be comprehensive. And I was just about to sound the

gavel until our very distinguished colleague, Senator Herb Kohl arrived.

Secretary THOMPSON. You can never sound the gavel when the

distinguished Senator from Wisconsin is here, plus the fact that his

Bucks are doing a great job in the championship, and we are pulling for them, and I hope the people in Iowa and Pennsylvania are

as well.

Senator SPECTER. I see the ruling of the Chair has been challenged?

And the ruling of the Chair has been defeated, so we will hear

from you, Senator, as we always do.

Senator KOHL. What do you want?

Thank you very much, Senator Specter.

Senator SPECTER. Senator Kohl and I have worked together very

closely, most noteworthy on the Ruby Ridge hearings, and I have

been trying to get him to autograph my copy for 5 years. That is

what I want.

Senator KOHL. Done.

Well, it is good to see you.

Secretary THOMPSON. Good seeing you, my friend.

Senator KOHL. Mr. Secretary, Governor.

Secretary THOMPSON. Thank you.

CHILD SUPPORT REFORM

Senator KOHL. Mr. Secretary, you visited my office before your

confirmation hearing and we talked about our shared interest in

reforming the child support distribution system.

Secretary THOMPSON. Right.

Senator KOHL. At that time you were just beginning your current

job, but now that you have had a few months and a budget under

your belt, I would like to discuss it just a little bit further. As you

know, under current law, a lot of child support money never actually reaches the child. Instead, the state and Federal Governments

keep it as reimbursement for their expenses. In Wisconsin, thanks

to your leadership, Mr. Secretary, our State——

Secretary THOMPSON. And your support, Senator.

Senator KOHL. That is right. We have a successful waiver program to send more child support money directly to families. I have

introduced legislation to give all states the option to follow Wisconsin’s example. The bill is included in the bipartisan Strengthening

Working Families Act, which includes several other administration

supported initiatives to help families succeed.

Given your long history on this issue and the bipartisan support

that we have had, can you tell us if the administration will support

this initiative?

Secretary THOMPSON. I know I do. I have not talked to the President about it, I am confident that he will, and if you want me to

find out how the administration feels, I will be more than happy

to, but I strongly support it because it is the right thing to do.
53

We pioneered that in Wisconsin, and the beauty of it is it gets

more money to the mother and to the children and it just makes,

you know, common sense. And so I am, I cannot say 100 percent

that the administration is in favor of it, but I am, and I will do

everything I possibly can to convince them if they are not, but I

would dare to say if we can get your bill introduced, you are going

to find this administration fully behind you support of it, Senator,

and I hope that you push it hard and I would love to be able to

be called to testify on it if and when there is a hearing on it.

Senator KOHL. Thank you, that is very encouraging.

Secretary THOMPSON. And I also want to thank you again for the

great job you are doing with the Bucks. It is great.

NURSING HOME INITIATIVE

Senator KOHL. Thank you very much, Mr. Secretary. I would like

to ask a question on nursing home enforcement. I have been fighting for several years to increase funding for nursing home inspections. Although most nursing homes do a good job, we still have

way too many nursing homes with serious problems, including malnutrition, dehydration and bed sores.

In response to these problems, the Clinton administration

launched a nursing home initiative which has had bipartisan support. This included mandates on State inspecters to make their inspections less predictable, to respond more quickly to complaints,

and to refer deficiencies for immediate sanctions.

The Federal Government is the primary source of funding to the

states to carry out these duties. Unfortunately, the President’s

budget flat lines this funding. If we know that substandard care is

a serious problem in our country and if we are all serious about

improving care, and I am sure you are, then we really have to invest in the inspection process. We have to give states the money

they need to protect their residents. How do you expect States to

carry out these critical duties if we do not have an increase in

funding? In other words, as you well know, the inspections often

times get nursing homes to do a better job, and if we do not increase our ability to do inspections, how can we expect nursing

homes to do a better job?

Secretary THOMPSON. We are reviewing all those rules and regulations, Senator. I have no definite answer for you at this point in

time. I think that sometimes we waste money and time continuing

to inspect the good homes, and should be spending more time on

the ones that have had violations in the past, got complaints, and

so on and so forth, and accentuate the surveys and inspections

there, and also do them at different time intervals so that nobody

knows that they are coming, and see if in fact we can improve the

quality of nursing care for our senior citizens all over.

And so, we are looking at that, and that is the best answer I

have for you at this point in time, but I will be more than happy

to sit down with you in the future to discuss it in further detail.

Senator KOHL. Okay. Again, I would just make the comment

which, I would like to hope you would at least partially agree with,

that to the extent that we inspect, we can expect to have some improvement; to the extent that we inspect less, we are in greater

peril. And as I said, the money for the inspections comes from us
54

here in Washington, so I think it is something that deserves attention.

Secretary THOMPSON. Okay.

Senator KOHL. Last question. As you know, Mr. Secretary, for

the past 7 years, Wisconsin’s nursing homes have been using

trained single task workers to help feed residents during busy

mealtime hours. This frees up more time for other nurse aides to

provide other critical services. Unfortunately, last year HCFA informed Wisconsin that this practice does not comply with federal

law. I am concerned that the immediate removal of all single task

workers would only worsen the staffing shortages that our nursing

homes are already facing.

I have introduced legislation to allow Wisconsin to continue

using single task workers as part of an eight-state demonstration

project. These workers would have to be trained and supervised at

all times, and a thorough evaluation of the project would be done

to determine their impact on quality of care.

Would the administration support this kind of demonstration

project, Mr. Secretary?

Secretary THOMPSON. Without a doubt, yes, and enthusiastically,

I might add, and it is a problem, and I think the rules that were

interpreted, the law needs to be changed, so that HCFA can make

the right interpretation. And I will be very supportive of it. I know

exactly what you are talking about. It is causing a problem not

only in Wisconsin, but nursing homes, especially in the midwest

and I presume across America, and it is something that needs to

be changed, the law needs to be changed, and let us push forward

with it as fast as we possibly can.

Senator KOHL. Well, I thank you, that is great to hear, and you

are a great guy and I have always felt that way, and since you

have been here in Washington, I increasingly feel that way and I

look forward to working with you.

Secretary THOMPSON. My privilege, sir, and thank you very much

for your kind words, and I feel the same about you.

Senator KOHL. Thank you, Mr. Secretary.

Senator SPECTER. Mr. Secretary, I have been involved in a few

of these hearings, none has surpassed all of the complimentary

comments about you. You got a lot of praise and a very high standard to live up to.

Secretary THOMPSON. I certainly do.

ADDITIONAL COMMITTEE QUESTIONS

Senator SPECTER. And I join all of the complimenters in saying

that we are confident that you will do it.

Secretary THOMPSON. Thank you very much, Senator.

[The following questions were not asked at the hearing, but were

submitted to the Department for response subsequent to the hearing:]

QUESTION SUBMITTED BY SENATOR ARLEN SPECTER

FAITH-BASED INITIATIVES

Question. President Bush’s Faith-Based plan created five faith-based centers. One

of the centers in located in HHS. What will be the role of the center? How will this
55

center be funded? How will this center interact with the White House Office of Faith

Based Programs?

Answer. Established by Executive Order on January 29th, 2001, the Center for

Faith-Based and Community Initiatives within the Department of Health and

Human Services will coordinate departmental efforts to eliminate regulatory, contracting, and other programmatic obstacles to the participation of faith-based and

other community organizations in the provision of social services. To maintain coordination with the White House Office of Faith Based and Community Initiatives

(OFBCI), HHS has designated a Center employee to serve as the liaison and point

of contact with the White House OFBCI, cooperate with the White House OFBCI,

and provide such information, support, and assistance to the White House OFBCI

as it may request, to the extent permitted by law. The President’s budget includes $3 million within the Administration for Children

and Families to fund the Center for Faith-Based and Community Initiatives in

2002.

Question. President Bush’s Faith-Based initiative calls for the expansion of Charitable Choice. What areas of Health and Human Services would benefit from this

proposed action?

Answer. Beginning in 2001, the HHS Center for Faith-Based and Community Initiatives will (a) conduct a comprehensive review of policies and practices affecting

existing funding streams governed by so-called ‘‘Charitable Choice’’ legislation to assess the department’s compliance with the requirements of Charitable Choice; and

(b) promote and ensure compliance with existing Charitable Choice legislation by

the department, as well as its partners in State and local government, and their

contractors.

Question. How will this expansion comport with the Constitutions Establishment

clause?

Answer. Charitable choice is often portrayed as a source of new federal financial

assistance made available to—indeed earmarked for—religious charities. It is not.

Rather, charitable choice is a set of grant rules altering the terms by which federal

funds are disbursed under existing programs of aid. As such, charitable choice interweaves three fundamental principles, and each principle receives prominence in the

legislation.

First, charitable choice imposes on both government and participating FBOs the

duty to not abridge certain enumerated rights of the ultimate beneficiaries of these

welfare programs. The statute rightly protects these individuals from religious discrimination by FBOs, as well as from compulsion to engage in sectarian practices

against their will.

Second, the statute imposes on government the duty to not intrude into the institutional autonomy of faith-based providers. Charitable choice extends a guarantee

to each participating faith-based organization [FBO] that, notwithstanding the receipt of federal grant monies, the organization ‘‘shall retain its independence from

Federal, State, and local governments, including such organization’s control over the

definition, development, practice, and expression of its religious beliefs.’’ In addition

to this broadly worded safeguard, there are more focused prohibitions on specific

types of governmental interference such as demands to strip religious symbols from

the walls of FBOs and directives to remake the governing boards of these providers.

A private right of action gives ready means of enforcement to these protections of

institutional autonomy.

Third, the statute reinforces the government’s duty to not discriminate with respect to religion when determining the eligibility of private-sector providers to deliver social services. In the past, an organization’s ‘‘religiosity,’’ obviously a matter

of degree not reducible to bright-lines, was said to disqualify providers found to be

‘‘pervasively sectarian.’’ That inquiry was always fraught with difficulties. Now,

rather than probing into whether a service provider is thought to be ‘‘too religious’’

as opposed to ‘‘secular enough,’’ charitable choice focuses on the nature of the desired services and the means by which they are to be provided. Accordingly, the relevant question is no longer ‘‘Who are you?’’ but ‘‘What can you do?’’ So long as a

provider is prepared to operate in line with all statutory and constitutional parameters, then an organization’s degree of ‘‘religiosity’’ is no longer relevant.

When discussing Establishment Clause restraints on a government’s program of

aid, a rule of equal-treatment or nondiscrimination among providers, be they secular

or religious, is termed ‘‘neutrality’’ or the ‘‘neutrality principle.’’ Charitable choice

is consistent with neutrality, but courts need not wholly embrace the neutrality

principle to sustain the constitutionality of charitable choice.

The U.S. Supreme Court distinguishes, as a threshold matter, between direct and

indirect aid. For any given program, charitable choice allows, at the government’s

option, for direct or indirect forms of funding, or both. Indirect aid is where the ulti-
56

mate beneficiary is given a coupon, or other means of free agency, such that he or

she has the power to select from among qualified providers at which the coupon may

be ‘‘redeemed’’ and the services rendered. In a series of cases, and in more recent

commentary contrasting indirect aid with direct-aid cases, the Supreme Court has

consistently upheld the constitutionality of mechanisms providing for indirect means

of aid distributed without regard to religion. The Child Care and Development Block

Grant Program of 1990, for example, has been providing low income parents indirect

aid for child care via ‘‘certificates’’ redeemable at, inter alia, churches and other

FBOs. The act has never been so much as even challenged in the courts as unconstitutional.

In the context of direct aid, the Supreme Court decision that has most recently

addressed the neutrality principle is Mitchell v. Helms. The four-Justice plurality,

written by Justice Thomas, and joined by the Chief Justice, and Justices Scalia and

Kennedy, embraced, without reservation, the neutrality principle. In the sense of

positive law, however, Justice O’Connor’s opinion concurring in the judgment is controlling in the lower courts and on legislative bodies.

Before proceeding in greater detail, the controlling principle coming from Mitchell

v. Helms can be briefly stated: A government program of aid that directly assists

the delivery of social services at a faith-based provider, one selected by the government without regard to religion, is constitutional, but real and meaningful controls

must be built into the program so that the aid is not diverted and spent on religious

indoctrination.

Based on Justice O’Connor’s opinion, when combined with the four Justices comprising the plurality, it can be said that: (1) neutral, indirect aid to a religious organization does not violate the Establishment Clause; and (2) neutral, direct aid to a

religious organization does not, without more, violate the Establishment Clause.

Question. The President’s budget shows new faith-based budget items under

Health and Human Services and proposes the expansion of others. Please share

with the subcommittee the details of the following policy items:

—Compassion Capital Fund

—Supporting Children of Prisoners

—Promoting Responsible Fatherhood

Will these programs need new authorization? If not, what is the existing authorization?

Answer. The new proposed discretionary initiatives represent a new Federal commitment in providing social services to those in need. Through these initiatives, the

Administration wants to spur new community-level approaches to working with lowincome families. The Administration will look to all successful sources of support for

those in need—faith-based organizations, charities, and community groups. These

groups do not replace Government, but partner with it.

The Compassion Capital Fund will provide start-up capital and operating funds

to qualified charitable organizations that wish to expand or emulate model social

service programs. The program will also promote research on ‘‘best practices’’ among

charitable organizations. Another new program, Mentoring Children of Prisoners,

will help children through the time their parents are imprisoned, including efforts

to keep children connected to a parent in prison, and increase the chances that the

family can come together successfully when the parent is released. The President

also proposes a program to Promote Responsible Fatherhood. To strengthen the role

of fathers in the lives of families, this initiative will provide competitive grants to

faith-based and community organizations that help unemployed or low-income fathers and their families avoid or leave cash welfare, as well as to programs that

promote successful parenting and strengthen marriage.

The President’s fiscal year 2002 budget proposes to fund both the Compassion

Capital Fund and the Mentoring Children of Prisoners program under existing authority within the Administration for Children and Families. The Administration is

proposing new legislation for the Responsible Fatherhood Initiative, and looks forward to working with the Congress on how to best structure this new program.

COMMUNITY HEALTH CENTERS

Question. You propose an increase of $124 million for community health centers.

This is less than the increase Congress provided last year, yet the budget justification says that this is the first step in a multi-year strategy that will eventually double the number of patients seen at community health centers. Could you explain

your strategy?

Answer. The President’s fiscal year 2002 budget for HRSA includes nearly $1.3

billion for Health Centers program, an increase of $124 million above the fiscal year

2001 appropriation. These additional funds in fiscal year 2002 will allow Health
57

Centers to create 200 new and expanded access points and serve up to 1 million

additional patients, almost half of them uninsured. The added funds represent the

first installment of the Administration’s multi-year initiative, which will eventually

increase or expand health center access points by 1,200 over five years and eventually double the number of people served.

RYAN WHITE PROGRAMS

Question. Why are there no increases for the Ryan White programs, not even for

inflation?

Answer. The President’s fiscal year 2002 budget includes over $1.8 billion for

Ryan White activities, the same level as fiscal year 2001. Ryan White activities have

increased by over 81 percent, or $812 million, in the last 5 years. By maintaining

funding at this level, grantees will be able to manage these significant increases and

address the changes included in the reauthorization of the Ryan White CARE Act.

HEAD START

Question. The President’s budget increases for Head Start is $125 million—an increase that only accounts for inflation. Last year’s budget increase allowed Head

Start to serve 60,000 additional children. This year’s budget will not allow any additional children to receive Head Start services. Can you explain the rational for this

budget?

Answer. The President’s budget provides $6.3 billion for Head Start in fiscal year

2002, $125 million increase above the fiscal year 2001 funding level. This funding

level will serve 916,000 children, the same number that was served in fiscal year

2001. The program has received significant funding increases in the past few years

and has undergone considerable expansion. In fiscal year 2002 we will work to ensure that the program has the opportunity to absorb this dramatic growth while focusing on strengthening pre-literacy and reading skills of the children.

Question. With the Head Start increase only accounting for inflation, can you tell

us how many eligible children will not be served in fiscal year 1902?

Answer. In 2002, Head Start will provide preschool services to 916,000 children

(including 55,000 children in Early Head Start), or approximately 60 percent of the

eligible population of 1.425 million 3- and 4-year old children nationwide.

CHILD CARE AND DEVELOPMENT BLOCK GRANT

Question. You have set-aside $400 million for use by the States to provide certificates for low-income parents to help defray the costs of after-school programs with

an educational focus. With only a $200 million increase in the child care block

grant, isn’t this an effective cut of $200 million in the block grant? Can you explain

how this program differs from the Department of Education’s 21st Century Learning

Centers.

Answer. The President’s budget supports child care services for 2.6 million children. This includes child care services for approximately 2.1 million children—the

same number supported in 2001—and certificates for up to 500,000 additional children to help parents defray the costs of after school child care programs which have

a high-quality educational focus. The certificates will be available for children who

are less than 19 years of age.

The block grant is only one portion of the total funds for the Child Care Development Fund. The fiscal year 2002 ACF budget includes $4.917 billion in Federal resources for the child care services. This funding represents a $350 million increase

to the fiscal year 2001 level of $4.567 billion.

The After School Child Care Certificate set-aside is designed to help pay the costs

of high-quality after school child care by putting money in the hands of parents who

need it. As we understand it, the 21st Century Learning Center program provides

funds to support after school programs at schools. The After School Child Care Certificate set-aside is directed to assist parents in paying for after school care, whether

in a school or other settings.

YOUTH VIOLENCE

Question. In January the Surgeon General issued a report on youth violence

which this subcommittee funded. The report was basically a review of existing literature and contained no new research. I continue to be concerned with the troubling outbreaks of violence by our teenagers. Do you plan to conduct new research

to help us understand the causes of violent behaviors and ways to prevent and treat

it?
58

Answer. The National Institute for Child and Human Development (NICHD) will

support research to understand how interactions between the brain, hormones, and

environmental stimuli lead to changes in teen behavior, including youth violence.

Researchers will also examine how these processes interact with external factors as

peers, family and the community.

The National Institute of Mental Health (NIMH) has learned that prevention programs must target multiple risk factors for youth violence, for example, poor adult

supervision, associations with deviant peers, lower verbal intelligence, family conflict, impulsive behavior, depression, social isolation, school failure, and substance

abuse. NIMH will continue and expand etiological and risk factor studies and will

expand research on youth violence interventions.

Question. Does the Administration have plans to address the role of media in contributing to youth violence?

Answer. From a public health perspective, the Surgeon General’s Report on youth

violence noted that the role of the media in contributing to youth violence is largely

uncharted territory. Few preventive efforts have been studied systematically. Furthermore, not enough research has been done to form a basis for the design of many

experimental interventions. Although many violence prevention programs address a

complex array of risk and protective factors in the lives of young people, they have

not yet addressed the role of the media.

Question. Mr. Secretary, given the unacceptably high rate of youth violence in the

United States and the reductions proposed in the budget, how will the HHS fiscal

year 2002 budget request support programs that address youth violence?

Answer. The fiscal year 2002 request for HHS Youth Violence activities totals

$103 million. Of this amount $90 million is for the Substance Abuse and Mental

Health Services Administration (SAMHSA). With these funds SAMHSA will provide

grants to schools and community organizations with the goal of building coalitions,

establishing prevention programs, and developing curriculum. Also included in the

fiscal year 2002 request is $11.6 million for the Centers for Disease Control (CDC).

This funding will allow CDC to develop and implement multi-disciplinary research,

develop and evaluate collaborative prevention interventions, and develop a training

curriculum. Funding in the amount of $1 million for the Office of Minority Health

will be used to expand the Family and Community Violence Prevention Program

and $400,000 for the Office of Surgeon General will fund a series of community listening sessions on topics highlighted in the Surgeon General’s Report.

QUESTION SUBMITTED BY SENATOR TED STEVENS

SPECIAL HEALTH NEEDS OF CHILDREN WITH MENTAL RETARDATION

Question. On March 5, 2001, at the hearing in Anchorage, the Special Olympics

officially released the special report on The Health Status and Needs of Persons

with Mental Retardation. Specifically, the Health Report found that (1) Although

persons with mental retardation need health and health financing programs that

are responsive to their particular needs, too often they are forced into general programs that actually can compromise their health. People with mental retardation

may not be receiving health services because they are under-insured; (2) The majority of health professional who are otherwise qualified to treat persons with mental

retardation fail to do so. This is largely the result of a lack of appropriate, specific

training, inadequate reimbursement policies, fear, and prejudice; (3) Existing federal, state and voluntary programs to meet the health needs of persons with mental

retardation are inadequate.

Mr. Secretary, what role can you play in training health professionals to address

the needs of person with mental retardation?

The report states that the health care system in this nation provides financial disincentives for physicians and other health care providers to work with patients with

mental retardation. What can be done to rectify this situation?

Answer. People with special health care needs have been of particular concern to

the Department for decades. Within HRSA’s Maternal and Child Health Bureau,

our concern with mental retardation has been a heightened priority for 50 years.

Currently, the MCH Leadership Education in Neurodevelopmental and Related Disabilities (LEND) program improves the health and quality of life of children who

have, or who are at risk for developing neurodevelopmental or related disabilities

by preparing trainees from a wide variety of professional disciplines to assume leadership roles to ensure high levels of clinical competence. By providing interdisciplinary long-term training, by developing exemplary clinical service models, and by

reaching out to the community through consultation, technical assistance, and con-
59

tinuing education, the LEND program has made and will continue to make significant strides towards developing comprehensive, coordinated services for infants and

children with the potential to have, or having developmental disabilities and for

their families. For fiscal year 2001, MCHB is providing $18.3 million through 35

grants in support of the LEND program.

In addition, the Administration on Developmental Disabilities, ACF, administers

a national network of University Centers for Excellence in Developmental Disabilities Education, Research, and Service (formerly known as University Affiliated Programs). There are 61 Centers that receive 5-year grant awards, for fiscal year 2001

the level of funding for each Center is $347,000. These Centers provide for interdisciplinary training, community services, research and technical assistance and information/dissemination activities. The University Centers are affiliated with medical schools, health care centers and hospitals. They are committed in furthering the

health care needs of this population. For example, University Centers must now report on the progress they have made on increasing the number of health care providers trained to meet the needs of people with developmental disabilities as a result of program intervention. The interdisciplinary training programs cover such

areas as: medicine, nursing, nutrition, physical therapy, speech pathology, social

work, audiology, bio-statistics, psychology and education. They also provide community services on behalf of persons with developmental disabilities, including individual assessments through clinical service programs and physician referral programs.

QUESTIONS SUBMITTED BY SENATOR TOM HARKIN

FEDERAL MENTAL HEALTH FUNDING

Question. Secretary Thompson, President Bush has expressed his interest in increasing Federal support for people with disabilities, including those with mental

illness, with the announcement earlier this year of his New Freedom Initiative. How

do you reconcile those expressed good intentions with a budget proposal that levelfunds and even cuts Federal mental health funding?

Answer. The Department of Health and Human Services is just one of several

agencies participating in the New Freedom Initiative, which will help increase access for and integrate individuals with disabilities into the community through assistive technologies, expanded educational opportunities, greater opportunities to

enter the workforce, increased access to community-based care and housing, and

other strategies. Increasing support for mental health services by leveraging federal

mental health dollars through better coordination is one of many components of this

initiative.

Other investments in HHS are also furthering the goals of the New Freedom Initiative. For example, the fiscal year 2002 budget for the Office for Civil Rights

(OCR) will support an increase in its efforts to work cooperatively with states to implement the Supreme Court’s Olmstead decision. OCR, the Health Care Financing

Administration (HCFA), the Administration on Aging, the Assistant Secretary for

Planning and Evaluation, the Substance Abuse and Mental Health Services Administration, the Administration for Developmental Disabilities and other components

within HHS are working together with states to help them ensure that individuals

with disabilities, including persons with mental disabilities, are provided with services in the most integrated setting appropriate to their needs. As states implement

plans to provide such services, they will be offering individuals with disabilities

more opportunities to move from institutional settings to community-based options

when community-based care is appropriate.

We are also encouraging States to consider special initiatives for persons with

mental illness as they take full advantage of some of the new opportunities from

HCFA. These include the grants and the Medicaid Buy-In newly available under the

Ticket to Work legislation. They also include the $70 million new ‘‘Systems Change’’

grants announced on May 18, 2001 that Senators Harkin and Specter were instrumental in crafting.

As you know, Medicaid is one of the most important programs for people with a

mental illness. As an entitlement program, Medicaid continues to expand as more

people need assistance. We look forward to working with you and focusing the attention of the President’s National Commission on Mental Health to determine if there

are additional things we could do to make Medicaid even more responsive to people

with mental illnesses.

The Substance Abuse and Mental Health Services Administration budget includes

$766 million for mental health services, a reduction of $16 million primarily for one-
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time projects which will end in fiscal year 2001. Even with this reduction, the Programs of Regional and National Significance will have $39 million available for

‘‘new activities’’ as other projects conclude in fiscal year 2001. In addition, twothirds of the individuals with substance use problems also have a mental illness and

many of these individuals will benefit from the President’s budget request for an

additional $100 million to support a Drug Treatment initiative.

CENTER FOR MENTAL HEALTH SERVICES

Question. The $16 million cut in funding for the Center for Mental Health Services would significantly impact the agency’s Best Practices or Knowledge, Development, and Application activities. Could you discuss how the Administration is proposing to address the need to disseminate research findings on best practices in

mental health service delivery to practitioners and providers in the field so that the

federal dollars devoted to this very important research are not squandered? Answer. The President’s budget includes $55 million in the Center for Mental

Health Services to support Best Practices or Knowledge, Development, and Application activities. Within this amount, SAMHSA will have $39 million to award in new

and competing grants and contracts for Programs of Regional and National Significance for mental health best practices in fiscal year 2002. The Center for Mental

Health Services has a strong commitment to disseminating to state and local communities, providers, consumers and other key stakeholders findings from the evaluation of its knowledge development programs. The Center is also dedicated to encouraging the adoption of those practices that will benefit persons with serious mental and emotional health and substance abuse problems. To achieve this mission,

the Center has funded several grant programs and contracts that use health communication and other social marketing strategies that increase awareness of evidence-based practices and encourage the incorporation of these practices into everyday service delivery. Specific activities include national training conferences, workshops, reports, technical assistance meetings, toolkits, mentorship programs, policy

and leadership academies and the use of advanced computer technology for dissemination and education.

PRESIDENT’S FISCAL YEAR 2002 BUDGET PROPOSAL

Question. The Community Access Program would be eliminated under the President’s budget. This program was designed to link uninsured and low-income individuals with health care services in their communities, including mental health services. The budget summary document points to increases in funding for community

health centers (CHCs) as a more efficient approach to the problem of the low-income

and uninsured not receiving services for which they are eligible. However, the budget dedicates this increased funding for CHCs to increasing the number of facilities

in existence, with a goal of 1,200 new centers. How much of this funding increase

will actually be used to address the fragmentation of public health services for the

uninsured and under insured and to help providers link their uninsured patients

with the services they need. Through the Community Access Program, 76 communities received assistance with improving coordination of care for the uninsured and

under insured. How many communities will receive this kind of assistance under

the President’s proposal?

Answer. The Administration is committed to identifying programs that are carefully designed and proven to bring more Americans who may not have good access

to care into the health care safety net. HHS will focus on the President’s commitment to expand direct health care services to the uninsured through Community

Health Centers (CHC), to which we are adding $124 million, for a total request of

approximately $1.3 billion. This multi- year Presidential Initiative will increase or

expand Community Health Center and Migrant access points by 1,200 over 5 years

and eventually double the number of people served. By targeting our resources to

expand CHCs, millions more Americans will have access to high quality health care.

The CAP program was created to provide short term assistance to local communities in order to transition to innovative service delivery approaches in order to ultimately be competitive within their own markets. Grantees were required to demonstrate that they were able to sustain the delivery of services and funding through

other public and private sources on a longer term basis. There are existing funding

resources that would enable communities to achieve similar goals as CAP. For example, CHC funding already supports the Integrated Service Delivery Initiative,

which provides funding to CHCs to support their efforts to integrate functions with

other centers and safety net providers in their community. The budget also includes

$15 million to support grants to States to develop designs for providing access to

health insurance coverage to all citizens of the State.
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NATIONAL HEALTH SERVICE CORPS

Question. The Administration has proposed no funding increases for the National

Health Service Corps (NHSC), citing that there is no longer a physician shortage.

Instead, the proposal is for target reforms to better address the mail distribution

and to increase available funds by eliminating the tax on scholarships and loan repayments. Eliminating the taxation and working on better distribution is all well

and good, but the Administration appears to have overlooked the fact that the Corps

provides funds for nurse practitioners, physicians assistants, dentists, psychologists

and other mental health provider. The nation, especially Iowa and the other rural

states continue to experience shortages of all of these providers. In Iowa, there remains a shortage of all of these providers. For example, the Corps is only able to

meet less than 7 percent of the dental and mental health care needs in Iowa. Furthermore, the nurses in Iowa are going out into the communities to deliver primary

care, but we need more of them.

How can the Administration rationalize not proposing a substantial increase in

funding for the National Health Service Corps by citing the lack of a physician

workforce? How are the Administration’s reforms going to meet the needs of the uninsured and most vulnerable Americans?

Answer. The National Health Service Corp Presidential Management Reform Initiative will improve the NHSC’s service to America’s neediest communities. The initiative will examine several issues, including the ratio of scholarships to loan repayments and other set-asides, and will consider amending the Health Professional

Shortage Area definition to include non-physician providers and J–1 and H–1C visa

providers practicing in communities. These efforts will enable the NHSC to more accurately define shortage areas and target placements to areas of greatest need. The

NHSC reform initiative will also encourage more primary health care professionals

to participate in the NHSC by making scholarship funds tax free.

The President’s budget includes a request of $126 million, in increase of $1.05 million over fiscal year 2001. These funds support NHSC clinicians serving communities, as well as outreach and development efforts in these communities. The funds

will also provide for recruitment efforts: 265 Federal Scholarships, 286 Federal Loan

Repayment agreements, 350 Federal Loan Repayment extensions, and 217 State

Loan Repayment agreements. Since the program’s inception, more than 22,000 clinicians have been providing services to millions of people in underserved areas. Currently, there are nearly 2,400 NHSC clinicians practicing in Health Professional

Shortage Areas.

COMMUNITY HEALTH CENTERS

Question. On April 12, 2000, Governor Bush toured the Grace Hill Community

Health Center in St. Louis. He used that occasion to propose increasing the number

of new community and migrant health centers by 1,200 over 5 years in an effort

to double the number of people served by these centers. The administration budget

proposal, however, calls for 1,200 new ‘‘and expanded’’ centers and there is no longer

a mention of doubling the number of people served. Moreover, the proposed increase

of $125 million for fiscal year 2002 falls well short of the mark needed to increase

funding by $3.6 billion over 5 years.

Is the Administration still committed to caring for the uninsured and most vulnerable Americans? How is the Administration proposing to reach its budget goal of

$3.6 billion over 5 years?

Answer. The President’s fiscal year 2002 budget for HRSA includes nearly $1.3

billion for the Health Centers program, an increase of $124 million above the fiscal

year 2001 appropriation. These additional funds will allow Health Centers to create

200 new and expanded access points and serve up to 1 million additional patients,

almost half of them uninsured. The added funds represent the first installment of

the Administration’s multi-year initiative, which will eventually increase or expand

health center access points by 1,200 over five years and eventually double the number of people served.

The Administration has also proposed a refundable tax credit to make health insurance more affordable for individuals and families not covered by an employer

plan nor eligible for public programs.

Finally, the Administration is developing ideas to improve the insurance options

available to lower-income individuals. We are working with States to more efficiently utilize Medicaid and SCHIP funding to increase the number of individuals

with access to affordable insurance, encouraging the availability of private group

health plan insurance coverage where possible.
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REAL CHOICE SYSTEMS CHANGE GRANTS

Question. Last year, the Appropriations bill included $50 million for Real Choice

Systems Change Grants. These grants had originally been included in MiCASSA

(Medicaid Community Attendant Services and Supports Act) to help states reform

their long term care systems to allow people with disabilities to live in their own

homes and communities. In addition, another $20 million for demonstration projects

to achieve this same goal.

HCFA announced the Real Choice funds should be used to develop public-private

partnerships to increase services and supports to people with disabilities. Will

HCFA ensure that people with disabilities, their representatives and their families

are members of the grant-funded state task forces? Answer. We have tried to be

very clear that Congress expressed its intent for States to develop their proposals

jointly with a consumer task force of broad representation. We will honor that intent, while simultaneously affording states with sufficient flexibility in the methods

of involvement that they can get the job done. For example, some states have asked

if their existing ADA/Olmstead planning committee could be used. Where such committees include broad-based consumer representation, we have answered affirmatively. HCFA also made the involvement of consumers an important aspect of its

review criteria for the grants. Finally, we made $50,000 ‘‘Starter Grants’’ available

to states in February in order to help defer some of their initial planning expenses,

particularly expenses associated with stronger efforts to involve people with a disability. We hope these efforts are successful in helping states achieve a robust level

of consumer involvement.

Question. Would you endorse the continuation of these dollars for the purpose of

funding similar grants -and demonstration projects in 2002?

Answer. No. These grants were designed to be one-time grants to assist States

in their effort to allow people with disabilities to live in their own homes and communities. We believe that the funding provided in fiscal year 2000 is sufficient to

achieve this goal.

COMMUNITY ATTENDANT SERVICES AND SUPPORTS

Question. Secretary Thompson expressed strong support for community-based

services for people with disabilities and the elderly during his confirmation hearing.

In Wisconsin, he championed the FamilyCare program to provide comprehensive

long term care services to people with disabilities and the elderly. In Iowa there has

also been an effort to provide more community-based services to people with disabilities and the elderly. Just last week, the Iowa Department of Human Services released a draft of the State’s Olmstead plan. And, the state is implementing the Ticket to Work and Work Incentives Improvement Act.

Both of these initiatives reflect a strong policy consensus—both nationally and in

Iowa—that people with disabilities should have the opportunity to live in the community and go to work.

In order to provide people with a real choice to live in the community, however,

many individuals with disabilities and the elderly need access to attendant services

and supports. Many states provide such services through waiver programs, but they

are often not Statewide or comprehensive in coverage. As a result, people remain

inside institutions or are on long waiting lists for appropriate community services.

There is a strong policy consensus that our long term care system is in need of

reform. Senator Specter and I are in the process of drafting a revised version of

Medicaid Community Attendant Services and Supports Act that would provide

states increased resources for community attendant services and other activities

that would ultimately remove the institutional bias of the current Medicaid program.

Is HCFA willing to work with us on this issue? How can the federal government

help states create a Medicaid long term care system that allows people with disabilities and the elderly the opportunity to live at home and in the community? Answer.

We believe that the stimulus provided by the Congress in the form of ‘‘Systems

Change’’ grants to States in fiscal year 2001, coupled with Department’s work to

more expeditiously process and approve waiver applications, will allow States the

opportunity to make additional investments in home and community-based services.

Additionally, we anticipate that this work will support the emergence of effectively

working systems that provide States the ability to provide cost-effective long-term

supports.
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QUESTIONS SUBMITTED BY SENATOR HARRY REID

CHRONIC DISEASE TRACKING SYSTEM

Question. Fallon, a small town in my home State of Nevada, is facing a terrible

tragedy. In the last 4 years, 12 children have been diagnosed with leukemia, eight

of them in a single year (2000), significantly more than would be expected in this

small community. The families are angry and scared and have very real concerns

that there may be some connection between this cluster of cancer and the environment, but currently neither the Environmental Protection Agency nor the Centers

for Disease Control or other involved Agencies in the Department of Health and

Human Services can offer any answers. Two weeks ago the Committee on Environment and Public Works held a field hearing in Fallon, and the witnesses, including

representatives of the Centers for Disease Control, Agency for Toxic Substances and

Disease Control and Environmental Protection Agency, and many State officials,

supported my call for comprehensive disease tracking and rapid response capability.

We had report language in last year’s bill that requested CDC put together a plan

for a chronic disease tracking system that looked at environmental factors. I look

forward to receiving and considering CDC’s report on this in the near future. And,

I especially want to ensure that, as CDC moves toward implementation of its plan,

it will do so in an integrated manner, not parcel the disease tracking network up

into separate silos. I do not want this to become a battle between fiefdoms, but rather a comprehensive health tracking system to protect the nation’s health.

How are you going to make sure that this tracking system is put together in a

strategic way and establishes a coordinated and comprehensive network?

Answer. In the fiscal year 2001 appropriations report, CDC was asked to report

back to this committee on plans to respond to the findings of the Pew Commission.

In response, CDC’s National Center for Environmental Health formed three CDC

workgroups with membership from across CDC. The workgroups are in the midst

of their work. One important next step is to begin a dialogue with our federal, state,

local and public partners to further define the core functions of what a tracking system would do and how it would be implemented. A second step would be to begin

planning to develop guidance and protocols for responding to disease clusters that

may be related to the environment. CDC will work closely with State and Local

Health Departments, professional organizations, e.g. CSTE, ASTHO, to develop

these protocols and guidance.

Question. Is this a priority? I heard at the hearing last week that Fallon is not

alone, that there are many other communities in the country that are facing unexplained disease clusters.

Answer. CDC is working diligently with existing funds to define core functions

and develop guidelines so that CDC can provide leadership to the main organizations who would be involved in this effort.

SUBCOMMITTEE RECESS

Senator SPECTER. Thank you very much, that concludes the hearing. The subcommittee will stand in recess until 9:30 a.m., Thursday, April 26, when we will meet in room SH–216 to hear from the

Secretary, Department of Labor, Elaine L. Chao.

[Whereupon, at 10:08 a.m., Wednesday, April 25, the subcommittee was recessed, to reconvene at 9:30 a.m., Thursday, April 26.]

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DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

THURSDAY, APRIL 26, 2001

U.S. SENATE,

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS,

Washington, DC.

The subcommittee met at 9:30 a.m., in room SH–216, Hart Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Harkin, and Landrieu.

ERGONOMICS

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. Good morning, ladies and gentlemen. The

Hearing of the Appropriations Subcommittee on Labor, Health,

Human Services and Education will convene. This special hearing

has been set on the subject of ergonomics.

Preliminarily, I want to note that we had an enormous group in

the corridor. I have not seen a line that extends so far to Constitution Avenue since Bill Gates Junior came to a hearing here a couple of years ago. And I was a little mystified to walk in and see

the seats empty here and all of the taxpayers in the corridor.

And I asked why people hadn’t come in and I was told you were

looking for an invitation. Well, let the record show you don’t need

an invitation to come to a public hearing. You don’t even have to

show your tax receipts.

I’ll just take judicial notice or senatorial notice that you are all

taxpayers.

Today’s hearing is on a very complicated subject. It has been convened to try to move the process forward as expeditiously as possible. I had thought that the issue of ergonomics was resolved in

our conferences on this subject, which go back many years where

we delayed the promulgation of a regulation and had an enormous

number of arguments until the regulation was supposed to have

been final.

But as George Schultz once said, nothing is final in Washington.

And we have what I consider to be an area of necessary governmental action.

We held an ergonomics hearing when the matter was listed for

revocation. Those Senate floor proceedings came up on short notice,

so we had a hearing with a number of witnesses and found that
66

the subject was very, very complicated and required a lot more inquiry.

We have a great many witnesses today. What we are going to try

to do is focus in on questions, with concise testimony from panelists. We welcome the new Secretary of Labor, Secretary Elaine

Chao. My distinguished colleague Senator Harkin has arrived, so

I will turn to him for an opening statement.

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. Thank you very much, Mr. Chairman and Secretary. It is good to see you again. I am glad to see we have a good

turnout here today for this hearing because this is an extremely

important hearing. And I thank you, Mr. Chairman, for holding

this hearing.

I want to thank also AFL–CIO and the National Academy of

Sciences and all who are here from the science and labor community for coming to testify today.

First, I want to make as clear as I possibly can how disappointed

I was that Congress and the President took the extreme action of

repealing this very important worker safety standard.

More than 2 million American workers each year report work-related MSDs and half of them lose time because of these injuries.

The ergonomic standards would have cut those numbers drastically. And we are talking about cashiers, nurses, cleaning staff,

assembly workers in manufacturing and processing plants, computer users, clerical staff, truck drivers, and meat cutters.

And this is not just a labor issue, it is a women’s issue because

women are the hardest hit. Women make up 47 percent of the

workforce. But in 1998, they accounted for 64 percent of the repetitive motion injuries and 71 percent of reported carpal tunnel syndrome cases.

A good example is Gloria Boyd from Waterloo. She worked 9

years on the assembly line in a pork processing plant. She has got

carpal tunnel so bad she can hardly pick up anything heavier than

a cup of coffee. Tell her, tell her that we do not need an ergonomic

standard. Someone tell her and tell her family that, would they.

This is a 15-page rule. And I have seen pictures of people waving

huge stacks of paper around. I have seen pictures of them holding

up big stacks of paper saying, Oh, this is how burdensome this

was; when this is it, 15 pages; 15 pages, not 200.

Second, this was a complaint-based rule and very flexible according to each workplace and job as a result of exhaustive studies we

know of over a decade. Some of my colleagues kept calling for more

studies of ergonomics and repetitive stress disorders.

What did we do? We kept authorizing more studies. Another National Academy of Science has studies in 1997, after two more before that. Then we continued to want to delay the rule. Well, the

NAS study of the studies, the study of the studies came out in January.

Once again, the National Academy of Science has found there is

strong scientific evidence that workplace exposures cause musculoskeletal disorders and they can be prevented. So I am glad that the

National Academy of Science is here today to present these findings.
67

What more do we have to do to prove that America’s workers are

suffering from these repetitive stress disorders and that there are

reasonable ways to prevent them.

With the attitude that seems to be prevalent around this town

today, I doubt if we could get a hard hat rule through like we did

30 years ago, no, 40 years ago, 30-something years ago, get a hard

hat rule through. Probably could not even get that today.

Well, yesterday, Madame Secretary, I understand you received a

petition signed by labor unions, civil rights organizations, women’s

groups, occupational health and safety groups, that urged the Administration to make it a priority to issue a new ergonomics standard.

It should not be that hard. We have studied it for over a decade.

We have got all the scientific basis on it. The work has been done.

Madame Secretary, I am told that you yourself said that workrelated repetitive strain injuries account for more than a third of

job injuries. And I think this is a quote from you. I did not hear

it but I read it, that we need a solid comprehensive approach to

new ergonomics rules.

Well, that is an encouraging statement. I want to know why the

standard that was issued was not solid and was not comprehensive.

And I would like to know what you are going to do and how soon

you are going to do it.

It is not enough, I do not think, to say that we are going to look

at this some more. I would like to know a deadline. I would like

to know when. And that is a question I am going to be asking you

is when are you going to set a deadline for having a new rule.

We have gone long enough. Many of our women, our workers, are

suffering lifetime injuries because we delay and we delay and we

delay and we delay. And we shove it under the carpet, refuse to

deal with it.

So if there are some things wrong with the last rule, I am more

than willing to listen, more than willing to take into account any

problems that may have been in it. But I do not want to see this

as an excuse to delay and delay and delay longer.

If things need to be fixed, let us fix them. I know the chairman.

He believes in worker health and safety as much as anyone around

here. And I know that we would work together. I think we could

work bipartisanly up here, but not if it just means we are just

going to dribble along year after year after year and not get anything done.

If we have a deadline and you have got solid suggestions, we are

more than willing to take a look at it. It is 2001. It is time to put

this sad chapter, this very sad chapter in ignoring the legitimate

rights of our people to have a rule that will protect them, that will

encourage businesses to make the modest minor changes necessary

to cut down on repetitive motion disorders, musculoskeletal disorders in the workplace.

With that, I thank you very much, Mr. Chairman.

Senator SPECTER. Thank you, Senator Harkin.

Let us refrain from applause. Let us not have any displays here.

Let us approach this hearing on a scientific basis and try to figure

out what the facts are and what the public policy ought to be.
68

Let us not have any teams on one side or another. Secretary

Chao, we welcome you here. We are going to limit very strictly the

witnesses because we have enough to occupy more than the day.

Our general rules are 5 minutes. We look forward to what you have

to say.

STATEMENT OF ELAINE L. CHAO, SECRETARY, DEPARTMENT OF

LABOR

ACCOMPANIED BY JOSEPH WOODWARD, ASSOCIATE SOLICITOR, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

Secretary CHAO. Thank you, Mr. Chairman and Senator Harkin,

and other members of the subcommittee. Thank you for inviting me

to testify about the need to reduce musculoskeletal disorders in

America’s workforce.

With me today is Joseph Woodward. He is the Associate Solicitor

for OSHA, the Occupational Safety and Health Administration.

When I testified before the Senate Health, Education, Labor, and

Pensions Committee at my confirmation hearing about 3 months

ago, I spoke about the challenges of preparing America’s workforce

for the emerging realities of the 21st century workplace.

The Department of Labor must remain in step with the dramatic

changes in our economy to fulfill its responsibilities to our workforce. And to meet this goal, I have established five priorities for

the Department.

One, is to ensure the safety of every workplace; Two, to guarantee an honest day’s pay for an honest day’s work; Three, to fight

discrimination; Four, to protect workers from coercion and intimidation; and Five, to make sure that workers’ compensation and

pensions are protected.

That first goal listed above, to ensure the safety and health of

every workplace, is my top priority. And it will remain so throughout my tenure as Secretary of Labor.

But I am also committed to bringing the workforce of the 21st

century in step with the needs and realities of our modern economy. And it is clear that the workplace of today is very different

from the workplace as it existed when the Department of Labor

was created in 1913.

Today’s employees are better compensated, better treated and

work fewer hours. They are also better trained, more productive

and more knowledgeable. And we must continue training a more

productive workforce in order to continue producing a better compensated workforce.

And so in that vein, I cannot resist a brief commercial for the Department’s upcoming 21st Century Workforce summit to be held at

the MCI Center on Wednesday, June 20 of this year. You are all

invited to join us as what is supposed to be and what promises to

be an extremely productive and rewarding day to talk about training and development for the 21st century workforce.

The workforce of the 21st century today is not only better off financially than it was a century ago, it is also far better off from

a safety perspective. In 1913, the year the Department was founded, the Bureau of Labor Statistics, part of the Department of

Labor, documented 23,000 industrial deaths among a workforce of

38 million people. This is equivalent to a shocking 61 deaths per

100,000 workers.
69

In 1999, the latest year for which figures are available, the Bureau of Labor Statistics reported 6,023 deaths among a workforce

of 134 million people or fewer than 5 deaths per 100,000; fewer but

still too many.

These numbers demonstrate that we have made great strides in

improving worker safety over the last century. And the Department

of Labor as well as our Nation as a whole should be commended

for its commitment to improving worker safety.

But these improvements also demonstrate that the new century

and the new workforce require a new approach to the safety needs

of the American workforce, an approach based on collaboration and

prevention rather than the antiquated adversarial approach of

years past. OSHA has a finite budget of $425.4 million in fiscal year 2001.

Securing the cooperation of employers and employees can help us

to leverage the effectiveness of our resources.

For example, several employers recently shared with us how they

have implemented their own ergonomics programs in collaboration

with their workers, and some with the assistance of OSHA’s consultative services.

The administration asks that OSHA place a greater emphasis on

preventing injuries through compliance, assistance and cooperation,

such as education, training and technical assistance programs,

rather than relying on command-and-control enforcement.

Because we are in a new century and facing a new kind of workforce issue, it is very important that the Department of Labor proceed carefully on the ergonomics question. As we begin this new

century, it is important to bring the stakeholders together, work on

creating a common knowledge base and a clear recognition of the

need for a consensus approach to this issue.

Since the Department has seemingly been looking into this issue

for so long, I think it might be helpful to lay out some of the history to give everyone a sense of the time line, and the controversy.

Senator SPECTER. Madame Secretary, we are interested in the

history but the time is very short. The red light has been on. Could

you summarize. Your full statement will be made a part of the

record.

PREPARED STATEMENT

Secretary CHAO. My full statement will be made a part of the

record, as you requested. And I will be more than happy to answer

any questions you have.

[The statement follows:]

PREPARED STATEMENT OF HON. ELAINE L. CHAO

Mr. Chairman, Members of the Subcommittee, thank you for inviting me to testify

about the need to reduce musculoskeletal disorders in America’s workforce. With me

today is Joseph Woodward, Associate Solicitor for Occupational Safety and Health.

When I testified before the Senate Health, Education, Labor, and Pensions Committee at my confirmation hearing three months ago, I spoke about the challenges

of preparing America’s workforce for the emerging realities of the 21st Century

workplace. The Department of Labor must remain in step with the dramatic

changes in our economy to fulfill its responsibilities to our workforce.

To meet this goal I have established five priorities for the Department:

—to ensure the safety of every workplace;

—to guarantee an honest day’s pay for an honest day’s work;
70

—to fight discrimination;

—to protect workers from coercion and intimidation; and

—to make sure workers’ pensions are protected.

That first goal listed above, to ensure the safety and health of every workplace,

is my top priority; it will remain so throughout my tenure as Secretary of Labor.

But I am also committed to bringing the workforce of the 21st century in step with

the needs and the realities of our modern economy. It is clear that the workplace

of today is so very different from the workplace as it existed when the Department

of Labor was created in 1913. Today’s employees are better compensated, better

treated, and work fewer hours. They are also better trained, more productive, and

more knowledgeable. We must continue training a more productive workforce in

order to continue producing a better-compensated workforce. In that vein, I cannot

resist a brief commercial for the Department’s upcoming 21st Century Workforce

summit, to be held at the MCI Center on Wednesday, June 20 of this year. You are

all invited to join us at what promises to be an extremely productive and rewarding

day.

The workforce of the 21st century is not only better off financially today than it

was a century ago; it is also far better off from a safety perspective. In 1913, the

year the Department was founded, BLS documented 23,000 industrial deaths among

a workforce of 38 million people—equivalent to a shocking 61 deaths per 100,000

workers. In 1999, the latest year for which figure are available, BLS reported 6,023

deaths, among a workforce of 134 million people, or fewer than 5 deaths per

100,000. Fewer, but still too many.

These numbers demonstrate that we have made great strides in improving worker

safety over the last century. The Department of Labor, as well as our nation as a

whole, should be commended for its commitment to improving worker safety. But

these improvements also demonstrate that the new century, and the new workforce,

require a new approach to the safety needs of the American labor force, an approach

based on cooperation and prevention, rather than the antiquated, adversarial approach of years past.

OSHA has a finite budget of $425.4 million in fiscal year 2001. Securing the cooperation of employers and employees can help us to realize a substantial return

on our resources. For example, several employers recently shared with me how they

have implemented their own ergonomics program—some with the assistance of

OSHA’s consultative services. The Administration asks that OSHA place a greater

emphasis on preventing injuries through compliance assistance and cooperation,

such as education, training and technical assistance programs, rather than relying

on command-and-control enforcement.

Because we are in a new century and facing new kinds of workforce issues, it is

very important that the Department of Labor proceed very carefully on the

ergonomics question. As we begin this new century, it is important to bring the

stakeholders together, work on creating a common knowledge base and a clear recognition of the need for a consensus approach to this issue.

TIMELINE

Since the Department has seemingly been looking into this issue for so long, it

might be useful to lay out some of the history, to give everyone, the Congress and

the American people a sense of the timeline, the controversy, and the activities over

the last twenty years. As you all know, last month, under the Congressional Review

Act, Congress repealed OSHA’s ergonomics standard. In signing the repeal, the

President emphasized that this Administration supports activities that will address

the critical challenge of reducing musculoskeletal disorders.

The repeal is only the latest action in the Department’s two-decade history with

this issue, dating back to the hiring of the Department’s first ergonomics specialist

back in 1979. You may be interested to know that that individual remains a valued

Department of Labor employee.

Since then, OSHA has been working steadily to determine the best possible position for the Department of Labor to adopt in order to ensure the health and safety

of the American worker. As the history shows, the Department and Congress have

been operating on a collision course for a number of years now, and this movement

forward without a consensus has put us in the predicament we are in today. At this

point it would be appropriate to submit into the record a timeline covering some of

this history.

The timeline I have just submitted is very useful in laying out the history of the

ergonomics standard. This history helps demonstrate why the original standard

failed—the rush to action, the lack of consensus, and the continual forward movement despite repeated congressional expressions of disapproval. This history makes
71

it clear why we need to take our time and to achieve a greater level of consensus

before proceeding.

WHY ERGONOMICS FAILED

It is vitally important that we avoid a repeat of the last ergonomics standard. It

would be wise to consider the factors that preceded last month’s vote by Congress

before charting a new course. OSHA should not rush when producing a new, comprehensive approach to ergonomics.

Last year, OSHA was asked to complete promulgation of the previous standard

in an unreasonable period of time. Many have stated that this was a standard that

began in the late 1980’s under former Secretary of Labor Elizabeth Dole. Now, we

know that the Department actually began looking at this issue in 1979. We also

know, however, that the new proposed rulemaking was announced in November

1999 and made final in November 2000. Within that same 12-month period, OSHA

received over 11,000 written comments on this rule, making up 188,547 pages. Piled

on top of each other, these comments and supporting documents would be 78 and

a half feet high. In fact, standing on top of this stack without a safety harness

would probably constitute an OSHA violation.

These thousands of pages of documents include complex scientific and mathematical analyses that only experts can understand. As you can see, this display illustrates just how complex this issue really is, and how much interest was generated by the last proposal. The rush to make the standard final, however, forced

OSHA to rely heavily on contractors to assist in the review of these documents. The

government has a responsibility to listen to the people, especially the regulated community.

Cost, scope of coverage and state jurisdiction were also concerns of the previous

standard. The disparity between OSHA and private sector cost estimates approached $100 billion. As a result, the Department will consider having future cost

estimates reviewed by an independent entity. The previous standard attempted to

cover a large number of businesses. The Department could help lower the overall

cost by focusing on high-risk occupations. State jurisdiction should also be preserved

by permitting States to administer workers’ compensation programs without Federal

intervention by OSHA.

DEPARTMENT ACTIVITIES SINCE CRA

In determining how best to proceed from this point, it is best to take advantage

of the expertise and experience of all parties involved in the issue. Since becoming

Secretary, representatives of unions, employers, safety and health professionals,

Congress, and members of the medical and scientific communities have all come to

the Department to share their thoughts on how to develop an effective strategy to

further reduce—and eventually eliminate—these injuries. The OSHA career staff

also provided a brief on the tools currently available under the Occupational Safety

and Health Act. I look forward to continuing discussions about the best method for

balancing the needs and concerns of management and labor while improving the

health and safety of America’s workers.

Some of the groups with whom we have met regarding this issue during my short

tenure as Secretary of Labor include:

—The president & workers from the United Commercial and Food Workers Union

—The AFL–CIO

—The Service Employees International Union

—The United Brotherhood of Carpenters & Joiners

—The United Brotherhood of Teamsters

—The Hotel Employees & Restaurant Employees International Union

—The Frozen Food Association

—The American Occupational Therapy Association

—The Food Marketing Institute

—The American College of Occupational and Environmental Medicine

—The American Society of Safety Engineers

In addition, we have also had extensive and multiple briefings with the dedicated

career staff at OSHA to discuss the Department’s activities and options on

ergonomics.

Finally, I would add that I am especially pleased to appear here before you today.

I consider meeting with Congress to be an important part of listening and learning

process on this subject.

One thing is clear from these meetings: there is no consensus on the ergonomics

issue. The stakeholders who have come to the Department of Labor to discuss

ergonomics are coming from completely different positions, ranging from those who
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want no action to those who thought that the previous rule did not go far enough.

In fact, after my testimony, you will hear from a number of other witnesses who

I expect will demonstrate the full range of these widely divergent points of view.

And therein lies the problem. This diversity of opinion suggests that precipitous action is not the wisest course at this time. If we want to find more common ground

on this issue, we will need to engage in more discussion and analysis, and we will

need more data.

PRINCIPLES

That said, we still do know a lot, and enough to begin thinking about the kinds

of approaches that could work, and more importantly, the starting point from which

we want to launch further activities. If we are to find common ground, it is important that there is at least general agreement on certain facts and philosophies before we reengage in the process that was reversed last month with the passage of

the CRA resolution. A great deal of resources, both in and outside the Department,

went into creating the ergonomics standard. Under the CRA, the Department is now

precluded from producing any standard that would be ‘‘substantially the same.’’ Before we expend valuable—and limited—resources on a new effort, we should agree

on general principles that the Department will follow in creating a new ergonomics

approach that fits the new 21st century workforce. These principles will provide a

vital starting point for common understanding, a point from which we can hope to

find common ground:

1. Prevention.—Everyone can agree that reducing occupational injuries is our top

priority. Fortunately, there is good news on this front. Recently, the Bureau of

Labor Statistics (BLS) released new data on job-related injuries and illnesses for

1999. The data show that there has been a continuing decline in musculoskeletal

disorders that result in employees missing time from work. Employers reported

582,300 such injuries in 1999, down from 592,500 in 1998 and from more than

763,000 in 1993. This 25 percent decline has occurred even though more Americans

were in the workforce. While I’m encouraged by this progress, I also recognize that

musculoskeletal disorders remain nearly one-third of all work-related injuries. The

Department should examine why these rates continue to decline, even in the absence of a specific ergonomics standard and while the number of annual OSHA inspections remains steady.

Clearly, more needs to be done to address the hazards that cause these injuries.

My goal is for the Department to develop an approach that will focus efforts on preventing injuries before they occur, rather than simply reacting after workers are

hurt. We would much rather prevent an injury than fine an employer in the aftermath of that injury.

OSHA has a finite budget of $425.4 million in fiscal year 2001. It is impossible

to inspect every workplace with this limited budget. This money is more effectively

spent, and protects more workers, if it is focused on prevention efforts. Prevention,

education and training are the most effective methods for providing the maximum

amount of protection to the greatest number of workers.

2. Sound Science.—Any Departmental action should be based on the best available science and research. In the previous Administration’s rush to issue an

ergonomics standard, they acted before the completion of a National Academy of

Science study that would have provided all stakeholders with more information on

the ergonomics standard. In the future, the Department should make sure that it

makes determinations based on the best available science.

3. Incentive-Driven.—OSHA has stated that 95 percent of employers are acting in

good faith. Employers understand that best safety practices are good for business

and are in the best interests of their workers. Any approach should be centered on

cooperation between OSHA and employers, rather than an adversarial relationship.

OSHA’s efforts with the meatpacking industry over the last 10 years demonstrate

how successful a voluntary approach to ergonomics can be. In 1990, OSHA published ergonomics guidelines for the red meat industry, ‘‘Ergonomics Program Management Guidelines for Meatpacking Plants.’’ One of the reasons the Agency chose

to publish guidelines for this industry was the unacceptably high injury rate to its

workers—20.2 cases per 100 employees. Many of these injuries were musculoskeletal disorders.

Many firms in the meatpacking industry used these guidelines and voluntarily

implemented programs in an attempt to decrease ergonomic injuries and lower their

annual workers’ compensation premiums. Over the last 10 years, the case rate of

total recordable injury cases dropped 39 percent, from 20.2 cases per 100 full time

workers in 1989 to 12.3 per 100 full-time workers in 1999. The case rate for injuries
73

involving days away from work also dropped substantially over this period, from 6.5

per 100 full-time workers to 2.0—a decrease of 70 percent.

Although these guidelines initially arose from an OSHA enforcement action, this

experience does demonstrate the potential effectiveness of voluntary, industry-specific ergonomics suggestions, especially in industries where the prevalence of musculoskeletal disorders is greatest.

4. Flexibility.—We must recognize the unique nature of individual workplaces—

avoiding an unworkable one-size-fits-all approach. The comments DOL has received

demonstrate that one of the biggest weaknesses of the failed standard was its universal nature. Every workplace is different and will need different tools and approaches to prevent ergonomic injuries.

5. Feasibility.—Small businesses complained that the cost of the previous stand- ard, estimated by the Department at upwards of $4 billion, and by private sources

at up to $100 billion, would have imposed a crushing burden on them. Small businesses need the Department to recognize the costs of compliance and the economic

constraints faced by small business.

6. Clarity.—The ergonomics standard took up over 600 pages, including preambles

and appendices in the Federal Register. While the standard represented only a portion of these, small business owners faced with the entire 600 pages of supporting

documents were understandably frightened. Small business owners lack the legal

resources to understand what is required to comply with complex regulations. As

a result, any approach to ergonomics must include short, simple, and common sense

instructions for employers and their employees.

WHAT’S NEXT?

The Department of Labor understands that there is some Congressional interest

in addressing ergonomic injuries through legislation. We ask for your patience. This

is a new Administration. We have made it our priority to review and understand

this issue by taking the time to meet with stakeholders, listen carefully to their concerns and construct principles that guide us to a comprehensive resolution. While

the Department is making significant progress, it will take time for us to effectively

complete our goal.

Defining the best, comprehensive approach for ergonomic injuries is not a simple

process. Occupational physicians explain that ergonomics involves soft tissue—including tears, scarring or inflammations, which can all be generated in places other

than the workplace. While the Department is focused on addressing ergonomic injuries acquired on the job, determining where a worker developed a tissue strain is

still subject to much debate. There is no set formula. No table exists. There is no

equation that permits us to simply plug in a worker’s injury and instantly determine its history. Because of the great difficulty of identifying many ergonomic injuries and establishing causality, these kinds of cases can require more investigative

resources than traditional workplace injury cases.

The Department of Labor wants to work with Congress in charting the best

course of action. The Department is here today because it is committed to providing

necessary protections to workers against ergonomic injuries. We applaud you, Mr.

Chairman, for holding this hearing, and look forward to working with you and hearing any suggestions you have for providing a sufficient remedy.

Senator SPECTER. Well, in the interest of brevity and to move on

to the substantive witnesses, I am just going to ask you one question with two parts. When do you anticipate having a regulation

finished, and what are the appropriate monitoring steps during the

course of the time line from now until the date you expect to conclude?

Secretary CHAO. Mr. Chairman, I would love to give you a time

line and a deadline. A time line we have a better handle over. A

deadline I do not think would do any one of us any particular good

in trying to accomplish the goal of reducing ergonomic injuries.

We have seen in the past an artificial deadline unreasonably imposed would in fact not bring about the result that we all share.

We are all in favor of reducing injuries. I totally agree with

you——

Senator SPECTER. Well, can you give us a time line? You say you

have a handle on a time line but cannot give a deadline.
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Secretary CHAO. Well, I think any regulation that goes through

OSHA depending on the scope, the complexity, whatever the

particular——

Senator SPECTER. Secretary Chao, would you take a look at the

scope and complexity and the history and give us a deadline or a

time line.

Secretary CHAO. I am not able to do that, sir. I am sorry. I am

unable to do that. I don’t think that is a responsible way to proceed.

Senator SPECTER. Senator Harkin?

Senator HARKIN. Madame Secretary, I guess what I am hearing

is that this is just going dribble on for another 10 years. Is it going

to be 10 years or 5 years?

Secretary CHAO. No, I do not have that kind of plan in mind.

Senator HARKIN. 2 years?

Secretary CHAO. Sir, with all due respect, I know that you would

like for me to say a specific deadline. I would be more than glad

to do that if that were a responsible course of action.

Unfortunately, that is not a responsible course of action in my

eyes. I want to do what is right. And the Department is unable to

come to a definitive deadline. And maybe what we can do is I will

ask, if I could, and I hate to put him on the spot, but Mr. Joe

Woodward is the Associate Solicitor.

Senator SPECTER. We do not want to put anybody on the spot

and we do not want to have a protracted debate about it.

Secretary CHAO. Fine.

Senator SPECTER. There is a deadline on my term. It is 6 years.

There is a deadline on the President’s term. It is 4 years. And I

do not think it is asking too much when this subcommittee asks

you for a deadline.

What I want you to do, if you will not interrupt me, Madame

Secretary, is to go back to the drawing boards and see if you can

give us some estimate as to when it is going to be concluded.

Secretary CHAO. I will do that. May I just add a few words

please?

Senator SPECTER. Of course.

Secretary CHAO. In my testimony, and I wish that people would

read the testimony, because the testimony was put together with

a great deal of thought and care, not for the purpose of delaying.

Because this testimony really lays out in depth our concern with

the subject, our desire to move forward in a responsible fashion.

I think one of the problems that has occurred in the past is that

there has not been consensus. And despite repeated appeals from

Congress to the Department on acting in a way that is responsible

to them, those steps have not been taken. And I am not saying anything bad about the department professionals. I am saying that

there were other forces at work.

And so I think if we were to proceed again without due consideration of all the various interest groups that are involved, I do not

think we are going to be crafting something that will be sustainable and that will be longstanding.

Senator SPECTER. Madame Secretary.
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Secretary CHAO. We are going to end up exactly where we were

prior to March 20. And that is not what I want. I want to do what

is right.

But I think a consensus of some sort has to be brought together.

I have met with all different kinds of groups. And the diversity of

opinions is truly vast. We have people on one spectrum who do not

want to do anything.

Senator SPECTER. Madame Secretary.

Secretary CHAO. I do not agree with that.

Senator SPECTER. You are repeating yourself. And we do not

have time for that. Consensus is fine, if you can get it. Consultation is what you have to do. That can be accomplished in a time

frame.

Around here, we all work under time pressures. We work on a

budget under a time pressure, and we work late, and we have a

vote-a-rama, and we have a schedule on appropriations, and we

have a fiscal year, and we have to meet deadlines.

And consensus is great if you can get it, but there are many regulations. Most regulations are issued without consensus. If you

could come to consensus, you would not need to have a Department

of Labor or a subcommittee or proceed with these hearings.

I want to proceed to call the first panel of witnesses. Senator

Harkin, you want one more question. OK.

Senator HARKIN. Madame Secretary, since you say you are going

to pursue this——

Secretary CHAO. Yes, of course.

Senator HARKIN. I had my staff look at your budget.

Secretary CHAO. Yes.

Senator HARKIN. How much is in your budget that you have devoted to this effort?

Secretary CHAO. We have a total OSHA budget of $425 million.

Senator HARKIN. I know what your total budget is. I want to

know how much you have devoted to an expeditious review of and

culmination of the effort to issue a new standard.

Secretary CHAO. I do not have that number with me. I will be

more than glad to get it for you.

Senator HARKIN. And would you submit that to this Appropriations Committee.

Secretary CHAO. I certainly will.

Senator HARKIN. I would like to see how much money and resources you are devoting to this specific effort.

Second, I have read your statement over. And what I do not see

in your statement, I do not see anything in your statement that

says here is what was really wrong with the rule that was promulgated, point by point, and here is how we fix it.

Now, could you submit that also for the record. I want to know

precisely what it is in this 15 pages of rules that you think are

wrong and that need to be corrected. Could you submit that for the

record?

Secretary CHAO. The Congressional Review Act was the action

that nullified the rule making.

Senator HARKIN. I understand that. I understand that.

Secretary CHAO. That is not our department. We did not nullify

the rule making. In fact——
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Senator HARKIN. But you are supporting that. And you are saying that that was the correct course of action to take. You are saying it was correct to have thrown this rule out. That is what you

are saying.

Secretary CHAO. Well, the rule has been deemed null and void.

Senator HARKIN. Yes.

Secretary CHAO. That does not mean that a new rule——

Senator HARKIN. But you are saying you support that, do you

not? You support that.

Secretary CHAO. The administration supports that and I support

that. Yes. Because I think a consensus, some kind of consensus is

necessary for us to be able to move forward. Because if we do not

find some commonality of interests, the Congressional Review Act

will once again be invoked. And any new rule will be void and nullified.

Senator HARKIN. I think——

Secretary CHAO. I am concerned about the workers. If we want

to really find a solution to reduce the injuries, we have to be able

to find——

Senator SPECTER. I regret interrupting but we have a lot of witnesses. And I think you have asked an appropriate question as to

what the Secretary disagrees with in the regulations.

We all know what the Congress did. If you would care to respond

to that, we would appreciate it. But we are not going to have a political debate here.

Secretary CHAO. You are right.

Senator SPECTER. That is what we are not going to do. What we

are going to do is try to identify what can be done to protect workers. And we have experts here on a wide variety of subjects that

is just staggering, including: work-related musculoskeletal disorders, work-related MSDs and interventions, cost benefits and feasibility of economic standards and options for new ergonomics

standards.

You have expressed yourself on consensus, Madame Secretary.

We understand that. Speaking only for myself, if you can get consensus, that is wonderful. If you cannot, you are going to have to

make a decision as the Secretary of Labor, and then Congress is

going to review that. Those are our procedures.

I would like to call the second panel now: Mr. Fellner, Dr. Bigos,

Dr. Hadler, Miss Seminario, Mr. Evanoff and Ms. Eberhardt.

Let us begin, Mr. Fellner, with a question as to what are musculoskeletal disorders, if any, which require Department of Labor

regulation.

STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON, DUNN

& CRUTCHER, LLP

Mr. FELLNER. Senator Specter, it is a pleasure to be before the

committee this morning and to participate in this important hearing. If I may, before I get to your question, may I put it in the context of the 5-minute statement that it was my impression we all

had an opportunity to give this morning. And with respect——

Senator SPECTER. Yes, you may.

Mr. FELLNER. I will certainly respond.
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Senator SPECTER. It would be the committee’s preference that

you focus on the subject matter for Panel 1 which I have just articulated.

Mr. FELLNER. And with pleasure. I will focus on that, but I

would like to put it in the context of my statement with your kind

permission, sir.

Senator SPECTER. I have already given you that. Proceed.

Mr. FELLNER. On March 6, the distinguished chairman convened

a special hearing to examine the issues surrounding OSHA’s now

rescinded ergonomics standard.

During the course of that hearing, I suggested that the next step

in determining what course the Department of Labor should take

should be an open and honest and exhaustive debate on the science

and economics, a course of action rejected by OSHA in the prior administration.

We are delighted, we are honored to participate in the beginning

of that process and to be part of such a distinguished panel of experts.

Given the scope of the issues, this process obviously cannot begin

and end in a single day. We expect that this open dialogue and

hopefully consensus will continue in the Department of Labor

under the able leadership of Secretary Chao. We do not expect the

answers to be easy.

The more one becomes familiar with these issues and their complexity, the more difficult it becomes to find areas of common

ground.

And I would like to introduce this debate, Mr. Chairman, by outlining some of the many issues about which there is considerable

disagreement first.

The nature of the problem broadly referred to as musculoskeletal

disorders or MSDs is poorly defined. And Senator Specter, if I may,

the problem and its definition runs the gamut from the definition

of the National Academy of Sciences of disorder, and that is what

we are talking about today, Senator, musculoskeletal disorders

which is an alteration in an individual’s usual sense of wellness.

That is the NAS definition. That is their amorphous definition.

OSHA, on the other hand, has defined musculoskeletal disorders

as injuries and illnesses that affect muscles, nerves, tendons, ligaments, joints or spinal disks. There is not even an agreement on

how to define the problem much less to cure it.

Number 2, you will hear extraordinary numbers today from the

non-medical witnesses representing the other side, 1.8 million,

650,000 annually. I agree with those numbers, Senator.

If we are talking about an alteration in a sense of wellness, there

are millions of those. If we are talking about illnesses, injuries,

there are very, very few of those.

Number 3, even the strongest proponents of ergonomics recognize

that work and non-work factors contribute to MSDs. Let me suggest in the interest of time that if a picture is worth a thousand

words, then I invite the attention of this committee to two pictures,

once again from the National Academy of Sciences; two pictures

which describe the complexity of the factors and the risk factors

that go into musculoskeletal disorders that include the physiology

of the human being, the psychology of the human being, the me-
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chanical factors to which he is exposed, the socioeconomic factors

that the human being finds himself into.

And to suggest that one can pluck one factor, the physical factor

out of this kaleidoscope of shards and regulate that one factor is

with all respect, Senator Specter, an impossible task based upon

the science that we presently know.

And speaking of that science, we do indeed have a distinguished

panel. We have brought four eminent medical doctors and researchers, not representatives of the National Association of Manufacturers, not representatives of the Chamber of Commerce, not individuals who are after sound bytes, but rather the folks that know the

science and will address the science. And the science is insufficient

to support an ergonomic standard as we presently sit.

PREPARED STATEMENT

Moreover, and with this I will conclude, when one is dealing with

the single-most expensive regulation in the history of the Department of Labor, and may I suggest with respect the greatest example of microengineering of the workplace in the history of this republic, the science better be sound before we proceed.

Senator SPECTER. Thank you very much.

Mr. FELLNER. With that, Senator Specter, I will conclude.

[The statement follows:]

PREPARED STATEMENT OF BARUCH A. FELLNER

Distinguished Chairman and members of the Subcommittee, I am a partner with

the firm of Gibson Dunn & Crutcher. Since OSHA’s inception almost 30 years ago,

I have practiced safety and health law, having shaped OSHA’s enforcement policy

in the Solicitor’s Office for its first decade and settled over 1,000 OSHA citations

in private practice. I am firmly committed to a strong OSHA—one which is actively

engaged in preventing accidents, illnesses and injuries in the workplace. On March

6, the Chairman convened a special hearing to examine the issues surrounding

OSHA’s now-rescinded ergonomics standard. During the course of that hearing, I

suggested that the next step in determining what course of action the Department

of Labor should take should be an open, honest and exhaustive debate on the

science and economics—a course of action rejected by OSHA under the prior administration. We are delighted and honored to participate in the beginning of that process and to be part of such a distinguished panel of experts.

For the past eight years, OSHA has committed enormous resources with a predisposition toward promulgating an ergonomics standard and without objectively

evaluating the underlying science, the costs, or the benefits of such a standard. In

the recent rulemaking, OSHA hired more than 20 outside consultants to aggressively advocate its position and to criticize dissenting comments. The resulting

ergonomics standard was perhaps single greatest experiment in social engineering

in the history of the Department of Labor. The costs of the rule would have been

staggering, and it had no clear scientific support. That standard is now rescinded.

But now we look to the future. This hearing is the first time there has been open

and honest dialogue regarding the scientific foundations and economic implications

of an ergonomics rule. Given the scope of these issues, this process obviously cannot

begin and end in a single day. We expect that this open dialogue will continue in

the Department of Labor under the able leadership of Secretary Chao.

We do not expect that answers will be easy to find. The more one becomes familiar with these issues and their complexity, the more difficult it becomes to find

‘‘areas of common ground.’’ I will introduce this debate by outlining some of the

many issues about which there is considerable disagreement.

—The nature of the problem—broadly referred to as musculoskeletal disorders or

MSDs—is poorly defined. MSDs encompass a variety of perceived maladies and

complaints that are not even described with consistent medical terminology.

Some define MSDs as objectively diagnosed ‘‘injury.’’ The National Academy of

Sciences characterizes MSDs as ‘‘disorders’’ that result in ‘‘an alteration in an

individual’s usual sense of wellness or ability to function.’’
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—Efforts to quantify the problem are hampered by the inherent difficulty of categorizing such diverse conditions and complaints. According to the Bureau of

Labor Statistics, the bedrock of the claims that an MSD epidemic exists are

principally based on 6 million employers interpreting one amorphous category:

‘‘sprains, strains and tears.’’ That is a category that encompasses the traumatic

and the cumulative, the objective and subjective symptoms, the disabling preexisting condition that has nothing to do with the workplace and the workplace

incident that aggravates but does not injure. And almost all of these judgments

are made by laymen. This is the stuff of soundbites, not science, as to the catastrophic state of ergonomic injuries.

—Even the strongest proponents of a standard agree that work and non-work factors contribute to MSDs. This NAS table is particularly helpful in showing the

complex web of suspected influences. There is sharp disagreement, however,

about the relative importance and contribution of these factors. The conclusions

of scientific studies are inconsistent and difficult to assimilate because they involve so many different aspects of this multi-faceted issue.

—No single, scientifically validated ‘‘exposure-response’’ relationship exists to provide a quantitative basis for a standard. This is not lead or asbestos, where relative scientific certainty suggests a permissible exposure limit. Without this

grounding, would-be regulators struggle between two equally unpalatable alternatives: a vague standard based on general goals such as a ‘‘material reduction’’

or making sure MSDs are not ‘‘reasonably likely to occur,’’ and a more specific

standard based on quantitative goals that lack scientific support.

—Those who espouse the benefits of ergonomics rely largely on anecdotal evidence. However, there is a dearth of scientifically supportable evidence—particularly scientifically reliable randomized controlled trials—on the effectiveness

of ergonomics programs. When we were all in fifth grade, we learned the importance of the scientific method; we seem to abandon that method when we are

engaged in social policy or social engineering. Anecdotal evidence of employee

complaints is unreliable because it may be tainted by factors unrelated to safety

or health. Research must focus on objectively diagnosed medical outcomes.

—Although the benefits of ergonomic controls are speculative, the costs are very

real. Even the prior Administration estimated annual costs of more than $4.5

billion, making ergonomics the second most expensive regulation since OMB

began its systematic review of regulatory impact. OSHA’s estimate, moreover,

was based on broad-brush estimates that ergonomic interventions will cost

around $150 per job, when the agency had a long track record of seeking interventions costing many times that amount. Industry estimates suggested that

the true total cost may exceed $100 billion, perhaps by many multiples.

As we set about for the first time to conduct an objective analysis of the science

and economics of ergonomics, it is necessary to proceed without pre-formed notions

as to the proper outcome. We hope that the Department of Labor will produce a detailed formal agency analysis that objectively and thoroughly considers all the evidence and comes to a conclusion about the appropriate government response, whether that be a comprehensive standard, a more narrowly targeted enforcement structure, a set of guidelines, or no action at all. The complete analysis and determination could then be published in the Federal Register and subjected to the open notice and comment process necessary to establish it as final agency action. When this

process is complete, we believe that OSHA will find the current state of scientific

knowledge woefully inadequate to support anything approaching the type of comprehensive standard-setting exercise recently rejected by Congress.

Senator SPECTER. Thank you very much Mr. Fellner. Proceed

now to Dr. Stanley Bigos, Professor of Orthopedics, University of

Washington. Dr. Bigos, the floor is yours.

STATEMENT OF DR. STANLEY BIGOS, PROFESSOR OF ORTHOPEDICS,

UNIVERSITY OF WASHINGTON

Dr. BIGOS. Thank you. It is an honor to be here today to participate in an open examination of a federally mandated ergonomics

rule. As a practicing orthopedic surgeon who deals with pain, a researcher and medical school professor, I have studied musculoskeletal problems for years and have engineered some of the principle studies regarding their causes.
80

Simply, I believe there is no scientific basis for a mandatory

ergonomic intervention at the workplace to prevent these nebulous

things that have been termed musculoskeletal disorders and we

refer to them as MSDs.

The best science regarding musculoskeletal disorders suggests

ergonomic proposals would actually be detrimental to the health of

American workers by medicalizing many of the undiagnosable

things that we in medicine cannot treat specifically. And if you cannot diagnose it, how do you prevent it.

Problems at work are a concern for all of us. We would all like

to make them go away. Unfortunately, there is very little consensus about how to define these MSDs and have virtually no reliable data regarding the prevalence.

If we were to rely upon the statistics that OSHA cited in the

final ergonomics rule, we would find that the vast majority of

MSDs consist of discomfort or pain, generally unavoidable back

pain that is a part of life.

I am not saying that this discomfort is imaginary. It is real. It

is very real for the people who experience it. I am merely pointing

out that when we speak about MSDs we generally are not referring

to physical injuries that are associated with tissue damage that can

be prevented or medically altered.

This point was recognized in the World Health Organization

meeting on January 14, 2000, in a scientific group where all the

participants agreed that we cannot continue to include aches and

pains as categorized as injury, arthritis or disease because it keeps

us away from the real goal of helping our patients.

My point is that many MSDs are nothing more than symptoms

without observable tissue damage. We are limited in medicine. And

because there is no reliable data regarding the prevalence, it is not

at all clear exactly what problem it is we are trying to regulate.

Even if we could identify the nature and scope of the problem,

there is no clear-cut science to support an ergonomics intervention.

The ergonomics hypothesis is that many MSDs are caused by certain kinds of repetitive motions in the workplace and this can be

alleviated by ergonomic controls alone. The problem with this hypothesis is that it is contrary to the best science available today.

The ergonomic hypothesis relies heavily upon studies that only

generate clues of association without actually studying the clues to

see if there can be an effective mechanism by which the problem

can be prevented.

In light of the overwhelming potential cost of an ergonomic intervention, no rule should proceed without some evidence of successful

intervention such as based on randomized control trials. No prospective RCTs at this point can guide us in altering the physical

work conditions as an ergonomic remedy to the problem.

In fact, the best science available does not support an ergonomic

hypothesis. This is especially true for back problems.

I directed the award-winning Boeing study that was summarized

in the publications in 1991 and 1992. The study was of 3,020 aircraft workers at the Boeing factory over a 4-year period to look at

the report of back problems.

We started with a retrospective study that provided us with

clues, and then we studied those clues to see about their impact on
81

the reported back problems. The non-physical factors outweighed

the physical factors in predicting back problems. The study found

no correlation between heavy lifting and work activities increasing

the report of problems.

In fact, the study found that some employees who routinely performed heavy lifting jobs in the paint shop, lifting 50 pounds with

their arms outstretched like this, totally against everybody’s ergonomic recommendation, and actually found that because of their—

probably because of their high job satisfaction, they were among

the least likely to report problems.

I also chaired the HCPR Guideline Panel which found no data

through a methodologic process that would support what is being

recommended in the rule.

In conclusion, I believe it is imperative for regulators to recognize

the past ergonomic proposals are not supported by the best science

available.

Let us pretend for a moment that the Food and Drug Administration has suddenly prescribed a specific drug mandatory for the

treatment of all patients with a particular problem. Further imagine that the FDA did not know the correct dosage of the drug as

we are stuck with, and does not know what side effects it might

have, and never subjected it to a single randomized trial. Doctors

would then guess the dose or just accept the strong data——

PREPARED STATEMENT

Senator SPECTER. Dr. Bigos, your full statement will be made a

part of the record. If you summarize the conclusion, we would appreciate it.

Dr. BIGOS. My point is I doubt that we would do that in medicine. And the whole point is why should an expensive, unproven,

potentially damaging approach be permitted simply based upon

unfound hypotheses because we are dealing with OSHA science

about the work site rather than the FDA science about our clinics

and our hospitals.

If we had the solutions, they would already be taken.

[The statement follows:]

PREPARED STATEMENT OF DR. STANLEY J. BIGOS

It is a pleasure to be here today to participate in an open examination of the scientific basis for a federally mandated ergonomics rule. An open discussion of this

nature is long overdue. As a practicing orthopedic surgeon, a researcher, and a medical school professor, I have studied musculoskeletal disorders for many years and

have engineered some of the principal studies regarding their causes. Based on my

extensive experience in this area, I believe that there is no scientific basis for mandatory ergonomic interventions in the workplace. To the contrary, the best science

regarding musculoskeletal disorders suggests that the ergonomic proposals we have

seen in the past would actually be detrimental to the health of American workers.

Presumably, ergonomics regulation in the workplace is intended to prevent musculoskeletal disorders (MSDs). Unfortunately, there is very little consensus about

how to define MSDs, and as a result there is virtually no reliable data regarding

the prevalence of MSDs in this country. If we were to rely on the statistics that

OSHA cited in its final ergonomics rule, we would find that the vast majority of

MSDs consist of discomfort or pain—generally unavoidable back pain—that is a part

of life and not accompanied by any observable tissue damage. I am not saying that

this discomfort is imaginary; it is very real to the people who are experiencing it.

I am merely pointing out that when we speak about MSDs, we generally are not

referring to physical ‘‘injuries’’ that are associated with tissue damage.
82

This point was recognized at the January 14, 2000 ‘‘Scientific Group’’ meeting of

the World Health Organization, when the whole conference of 450 participants

agreed that musculoskeletal pain is not equivalent to injury, arthritis or disease.

Because many MSDs are nothing more than symptoms rather than observable tissue damage, and because there is no reliable data regarding the prevalence of

MSDs, it is not at all clear exactly what the problem is that we are trying to regulate.

Even if we could identify the nature and scope of the problem, there is no clear

scientific support for ergonomic interventions. The ergonomics hypothesis is that

many MSDs are caused by certain kinds of repetitive motion in the workplace, and

thus can be alleviated by ergonomic controls alone. The problem with this hypothesis is that it is directly contrary to the best science that is available today.

The proponents of the ergonomics hypothesis generally rely on studies that are

useful in generating clues about associations, but that cannot establish the causes

of MSDs sufficiently to prevent it. In light of the overwhelming potential costs of

ergonomic intervention, no rule should proceed without some true evidence of successful intervention such as a based on randomized controlled tests (RCTs). No prospective RCTs have ever been conducted to assess the effectiveness of altering physical work conditions as an ergonomic remedy.

In fact, the best science available regarding the causes of MSDs suggests that the

ergonomics hypothesis is wrong. I directed The award winning Boeing Study,

‘‘termed sentinel science’’ that was summarized in publications in 1991 and 1992.

The Boeing study was a prospective cohort study of the reporting of back injury

claims (not merely complaints) among 3020 aircraft workers at the Boeing facility

over 4 years following a retrospective analysis of back injury claims. That study

found that non-physical factors outweighed physical factors in predicting the report

of back problems at work. The study found no correlation between heavy-lifting

work activities and increased reporting of back problems at work. In fact, the study

found that some of the employees who routinely performed heavy lifting (paint shop)

but who had high job satisfaction were among the least likely to report back problems at work.

I also chaired the panel of experts that produced the Agency for Health Care Policy & Research (AHCPR) Guidelines for Low Back Problems, which was published

in 1994. The AHCPR Guidelines were produced by a panel of experts brought together under the direction of the U.S. Department of Health and Human Services

to conduct an exhaustive methodological review of the existing literature on the

back problems. The panel evaluated more than 10,000 abstracts and obtained more

than 4,600 studies for methodological evaluation. Based on that review, the evidence

suggested that continued activity rather than decreased activity would be helpful in

alleviating many types of back problems—a finding that is directly contrary to the

ergonomics hypothesis—and the panel found no valid evidentiary support for the

use of ergonomics interventions to treat or prevent back pain. The AHCPR Guidelines have since been followed and updated in over 45 countries, including the

United Kingdom, Australia, and Israel. Subsequent research has only strengthened

many of the key findings of the AHCPR panel.

In conclusion, I believe it is imperative for regulators to recognize that the ergonomic interventions that have been proposed in the past are not supported by the

best science available, and there is a considerable body of evidence which suggests

that certain ergonomic interventions may actually be physically harmful to American workers and slow their return to productive life.

Let us consider for a moment the Food and Drug Administration, which is explicitly charged with evaluating healthcare interventions. Imagine that evidence-based

medicine had demonstrated no support for an expensive experimental class of drugs

designed to treat heart disease. Imagine that, nevertheless, the FDA suddenly prescribed a specific drug as the mandatory treatment for all patients. Further imagine

that the FDA did not know the correct dosage of the drug, did not know what side

effects it might have, and never subjected it to a single randomized control trial.

Doctors would guess the dose and accept opinion that strongest data about the issue

is wrong? I doubt it! The medical community would never be permitted to do this.

Why should an expensive unproven and potentially damaging approach be permitted simply based upon unfounded hypotheses because we are dealing with

OSHA’s science about the worksite rather than the FDA’s science about the clinic

or hospital?

Senator SPECTER. Thank you very much, Dr. Bigos. Dr. Nortin

Hadler, Professor of Medicine and Microbiology/Immunology, University of North Carolina, Chapel Hill.
83

STATEMENT OF DR. NORTIN M. HADLER, PROFESSOR OF MEDICINE

AND MICROBIOLOGY/IMMUNOLOGY, UNIVERSITY OF NORTH

CAROLINA, CHAPEL HILL

Dr. HADLER. Good morning. I want to express my gratitude to

the members of the subcommittee for the opportunity to address

you today on issues with which I have grappled as a clinician and

clinical investigator for over 25 years.

I am a rheumatologist and therefore committed to caring for patients with musculoskeletal disorders. As an academician and clinical investigator, I was drawn early on to improve our understanding of the plight of those amongst us who are otherwise well

but in the course of our usual life activities face compromised function because a particular anatomical region such as our low back

or arm is painful to move.

I coined the term ‘‘regional musculoskeletal disorders’’ to denote

this morbidity nearly 20 years ago. Gainful employment is one

realm in which function is placed at risk by a regional disorder.

That is the so-called MSD in OSHA’s terminology.

But the illness of work incapacity is not the only morbidity, nor

is the workplace the only context relevant to the regional disorders.

The fact the working capacity from the regional disorders has engendered ergonomic-based regulatory efforts is a social construction

that bears very close scrutiny.

We have access to a compelling science that suggests such a social construction deprives the hurting worker of insights that could

lead to substantive relief. Hopefully, such an understanding will

emerge during the course of today’s hearing.

In this, the first of my two presentations, I will focus on the following aspects of the epidemiology of the regional disorders: Who

is at risk, how common is the morbidity, what are the options for

coping, and what drives the choice amongst the options.

Notice that I continue to use the term regional musculoskeletal

disorder. I am willing to specify the region, the knee or low back

or neck or shoulder and the like, but seldom am I willing to apply

a label that suggests I know what is hurting.

For nearly all the regional disorders, there is no way today to

general confidence that any anatomically exact label is valid. Nearly always there is nothing to see or feel. All our wonderful techniques for imaging anatomy seldom shed any light. Either no pathology is demonstrated or that which is demonstrable is nonspecific.

It is commonly found in age matched individuals who are not

hurting, is likely to have been present in the person who is hurting

before the onset of pain, and likely to persist when the pain has

remitted.

Regional musculoskeletal pain is an intermittent and remittent

predicament of life for all of us. It is distinctly unusual to live a

year without having had to cope with a backache or 3 years without having to cope with arm pain.

We know this from surveys where volunteers keep diaries of the

morbidity they experience each day and from surveys where recall

of the disorders is elicited. The response varies depending on how

the questions are asked, but the message is inescapable. Regional
84

musculoskeletal pain is an intermittent and remittent predicament

of life.

In the past decade, there have been a number of investigations

which explore the fashion in which people cope with these episodes.

Coping does not occur in a vacuum. Common wisdom and advice

abounds, as do many purveyors of putative remedies.

For most of us, most of the time, we can and do cope according

to our fashion. For most of us, most of the time, the predicament

passes and it is not even memorable. What makes it memorable.

What causes us to seek care from a provider. If you think the answer relates simply to the severity of the pain, you need to be disabused.

Aspects of life that confound coping render the musculoskeletal

disorders more memorable and less tolerable. Measures of feeling

undervalued, of being undervalued, of feeling disaffected, and of

self-reported health status associate with the likelihood of remembering and seeking care for back, knee or arm pain. We have

known for decades the measures of the severity of the pain itself

correlates less well or not at all.

No doubt there is the exceptional person who is faced with a regional disorder of such intensity and persistence that it overwhelms all attempts to cope. Such a person deserves the empathetic care that we would offer anyone with any other of life’s morbid challenges such as a severe case of the flu. But these are unusual circumstances.

Most people either on their own or with guidance discover ways

to circumvent the painful use of the region that is hurting until in

days, occasionally weeks, rarely months, the disorder remits sufficiently that life goes on and the episode is soon to be forgotten.

When someone finds the disorder insurmountable or even unforgettable, it is likely that coping was confounded by the psychosocial

context in which the morbidity was suffered. These psychosocial aspects of life operate to render the episode memorable, to cause one

to register the complaint to a health officer inside or outside the

workplace.

This is not to dismiss the backache or the regional arm pain as

trivial or to belittle the effort involved in coping. We will all face

such challenges and hopefully we will all have the wherewithal to

cope effectively. But I can assure you, if you are trying to cope with

a backache and your life is not in order, if there are coincident

challenges at home or work, then the backache will seem the last

straw.

PREPARED STATEMENT

Senator SPECTER. Dr. Hadler, your full statement will be made

a part of the record. Can you summarize in conclusion please.

Dr. HADLER. Yes. The conclusion will come in my second statement. There is absolutely no information as to whether we can

alter the likelihood that we will suffer our regional disorder. There

have been attempts to alter the likelihood that we will not cope on

our own. And the best data we have say such attempts are ineffective. Thank you for your attention.

[The statement follows:]
85

1 Hadler, NM. Workers with disabling back pain. N Engl J Med 1997;337:341–3.

2 Hadler, NM. Comments on the ‘‘Ergonomics Program Standard’’ proposed by the Occupational Safety and Health Administration. J Occup Environ Med 2000;42:951–969. 3 Hadler NM. Arm pain in the workplace: a small area analysis. J Occup Med 1992;34:113–

9. 4 Hales RR, Sauter SL, Peterson M, et al. NIOSH health hazard evaluation report (HETA

1989–299–2230, U.S. West Communications). Washington, DC: Department HSS, PHS, CDCP,

NIOSH. 5 Hales T, Sauter SL, Peterson MR, et al. Musculoskeletal disorders among visual display terminal users in a telecommunications company. Ergonomics 1994;37:1603–21.

PREPARED STATEMENT OF DR. NORTIN M. HADLER

When I was a medical student, epidemiologists observed that the risk for Down’s

Syndrome, trisomy 21, was not uniform in sibships. The youngest child was more

likely to be afflicted with this congenital disorder. That lead to hypotheses and research as to what was it about the multiparous uterus that caused the fertilized egg

to divide abnormally.

Several years later, epidemiologists returned to this issue to test whether they

had missed the real association. The younger the child, the older the mother. Could

it be that the likelihood of bearing a child with Downs’s syndrome associated more

with maternal age than birth rank? The answer proved to be yes. The old hypothesis was superseded and research shifted to the biology of the aging ovary.

Several years after that, epidemiologists again returned to this issue to test

whether they had missed the real association. The older the mother, the older the

father. Could it be? The answer was yes and no. The likelihood of bearing a child

with Down’s syndrome associated with both maternal and paternal age. The old hypothesis was superseded and research shifted to the biology of the aging ovary and

testis.

Such is the scientific method. We learn from the old hypotheses and the old false

starts. And we move on. Today, no one would consider studies of the microenvironment of the multiparous uterus as relevant to the pathogenesis of Down’s syndrome.

For over 60 years science has sought associations between the physical demands

of tasks and the likelihood of suffering disabling regional back pain. For 30 years,

there have been parallel studies between physical demands of tasks and disabling

arm pain. Associations have been found, but they are inconsistent and weak. There

were hints 30 years ago,1 but science has really risen to the challenge in the past

decade, the challenge of asking whether a more important association was being ignored. I have reviewed this transition in a lengthy editorial in the Journal of Occupational and Environmental Medicine last fall 2 titled ‘‘Comments on the

‘‘Ergonomics Program Standard’’ proposed by the Occupational Safety and Health

Administration’’ which I have submitted with the written version of this statement.

I review the number of cross-sectional and longitudinal studies that have attempted

to probe for associations between disabling regional back or arm pain and aspects

of BOTH the physical content of tasks and psychosocial context of work. Designing

such studies is demanding. How do you measure either physical or psychosocial exposures given the enormous temporal variability and individual differences? You do

the best you can. The result of these multivariate studies is that the associations

with the physical content of tasks are weaker and even more inconsistent. The associations with the psychosocial context of work are also weak, but they are more consistent and generally subsume the associations with the physical content of tasks.

I could belabor this new literature; it deserves scrutiny. However, I can not applaud the insistence on relying on the older literature in the systematic reviews that

are promulgated by NIOSH and the NRC. Any study that considers only the association between the physical demands of tasks and the likelihood of a disabling regional musculoskeletal disorder is out of date, even if it is on-going or proposed. The

state-of-the-science has moved beyond the testing of that hypothesis to newer

hypotheses that promise to be more informative.

Let me illustrate first with two small area analyses. There are large companies

that have multiple work sites each with similar facilities and similar demographics

of the workforce. The incidence of disabling back or arm pain varies from site to

site, sometimes dramatically. That offers the opportunity to explore whether measurable differences in task content, demographics or psychosocial context associate

best with the variability in the incidence of disabling regional musculoskeletal disorders. Independently, investigators from NIOSH and I performed such a small area

analysis in US West directory assistance operations.345 Neither the NIOSH investigators nor I could explain the site-to-site variability in the incidence of disabling

arm pain by any aspect of task content. However, multiple aspects of the psychosocial context of work did associate, fear of redundancy, work pressure, and lack of
86

6Linton SJ. A review of psychological risk factors in back and neck pain. Spine 2000;25:1148–

56.7Marmot M. Importance of the psychosocial environment in epidemiologic studies. Scand J

Work Environ Health 1999;25(suppl 4):49–53. 8 Helio ̈vaara M. Work load and back pain. Scand J Work Environ Health 1999;25:385–6. 9Krause N, Ragland DR, Fisher JM, Syme SL. Psychosocial job factors, physical workload,

and incidence of work-related spinal injury: a 5-year prospective study of urban transit operators. Spine 1998;23:2507–16. 10 Burton AK. Back injury and work loss. Biomechanical and psychosocial influences. Spine

1997;22:2575–80. 11Papageorgiou AC, Macfarlane GJ, Thomas E, Croft PR, Jayson MIV, Silman JA. Psychosocial factors in the workplace—do they predict new episodes of low back pain? Spine

1997;22:1117–1142. 12 Hansson TH, Hansson EK. The effects of common medical interventions on pain, back function, and work resumption in patients with chronic low back pain. Spine 2000;25:3055–64. 13 Van Tulder MV, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common

interventions. Spine 1997;22:2128–56. 14Davis KG, Heaney CA. The relationship between psychosocial work characteristics and low

back pain: underlying methodological issues. Clin Biomechanics 2000;15:389–406. 15 Israel BA, Baker EA, Goldenhar LM, Heaney CA. Occupational stress, safety and health:

conceptual framework and principles for effective prevention interventions. J Occup Health

Psychol 1996;1:261–86. 16Karasek RA, Theorell T. Healthy Work. New York:Basic Books, 1990. 17Guastello SJ, Johnson EA, Rieke ML. Nonlinear dynamics of motivational flow. Nonlinear

Dynamics, Psychology, and Life Sciences 1999;3:259–73. 18 Vahtera J, Kivima ̈kl M, Pentti J. Effect of organisational downsizing on health of employees. Lancet 1997;350:1124–8.

decision authority to mention a few. Interestingly, the more overtime and the more

hours spent at the computer, the LESS likely the operator was to have found arm

pain disabling.

Another small area analysis was performed by UPS. The results were submitted

as part of the rules making process regarding OSHA’s ‘‘Ergonomics Proposed Standard’’ last year. A detailed ergonometric analysis was performed at a number of UPS

hubs where the tasks involve the sorting of parcels. There is not even a hint of an

association between physical task demands and the likelihood of recorded disabling

arm or back pain.

What do I mean by impugning the psychosocial context of work? What is the

human implication of these small area analyses and nearly all multivariate crosssectional and longitudinal studies that detect associations with the psychosocial context of working 6 7 8 9 10 11 and the likelihood of reporting to a health officer in the

workplace that your regional arm or back pain is disabling? I do not mean to impugn the veracity or the motivation of any worker so afflicted. Nor am I suggesting

that the inflammatory social construction, ‘‘It’s in your head’’ pertains. I believe they

hurt and I am saddened that their pain is insurmountable. I know that the remedies offered by the providers of today are no matches for this dilemma; 12 13 at best

they are minimally helpful, most are useless and offer the specter of iatrogenesis.

However, the science of today forces me to conclude that their back or arm pain is

rendered incapacitating because elements of the psychosocial context in which they

work impede coping. The frontier for epidemiology is to further define ‘‘psychosocial

context.’’ That’s a daunting exercise.14 Some of the common threads emerging from

studies in the workplace include aspects of job ‘‘stress,’’ 15 ‘‘strain,’’ 16 ‘‘allostatic

load’’ and motivational ‘‘flow.’’ 17 These measures are sampling such complex psychological functions as satisfaction, autonomy and security on the job as well as perceived psychological demand, motivation, collegiality, and the like. No wonder, associations with ‘‘psychosocial’’ variables are weak, even inconsistent. There may be

much that is idiosyncratic. However, that does not diminish the implications. The

sad fate of the hurting worker(s) is predetermined if he or she, or they are trapped

in a malignant psychosocial milieu.

There are 4 cohort studies that bear witness. Two are ‘‘natural’’ experiments in

that a captive workforce was followed through an interval when the psychosocial environment was purposely perturbed: In the early 1990’s, the Finnish economy suffered a considerable setback lasting several years. Many workers were dismissed.

The effect of impending downsizing on the local-government employees in one small

city was monitored.18 The rate of absenteeism escalated, most markedly for sick

leave ascribed to regional musculoskeletal disorders, particularly among employees

over the age of 50.

The ‘‘Whitehall’’ studies are cohort studies of British civil servants that long ago

documented an inverse relationship between civil service grade and mortality rate,

particularly mortality from cardiovascular disease. In recent years it has become
87

19 Bosma H, Peter R, Siegrist J, Marmot M. Two alternative job stress models and risk of coronary heart disease. Am J Public Health 1998;88:68–74. 20 Hemingway H, Shipley MJ, Stansfeld S, Marmot M. Sickness absence from back pain, psychosocial work characteristics and employment grade among office workers. Scand J Work Environ Health 1997;23:121–9. 21Ferrie JE, Shipley MJ, Marmot MG, Stansfeld SA, Davey Smith G. An uncertain future:

the health effects of threats to employment security in white-collar men and women. Am J Public Health 1998;88:1030–6. 22 Reissman DB, Orris P, Lacey R, Hartman DE. Downsizing, role demands, and job stress.

J Occup Environ Med 1999;41:289–93. 23 Croft P, Schollum J, Silman A. Population study of tender point counts and pain as evidence

of fibromyalgia. BMJ 1994;309:696–9. 24 Borg V, Kristensen TS, Burr H. Work environment and changes in self-rated health: a five

year follow-up study. Stress Med 2000;16:37–47. 25 Cheng Y, Kawachi I, Coakley EH, Schwartz J, Colditz G. Association between psychosocial

work characteristics and health functioning in American women: prospective study. BMJ

2000;320:1432–6. 26 Hadler NM. Laboring for longevity. An annotated poem. J Occup Environ Med. 1999;

41:617–21. 27 Hadler NM. Occupational Musculoskeletal Disorders. Second Edition. Philadelphia,

Lippincott Williams & Wilkins. 1999. Pp. 1–433.

clear that the association with grade paled next to the association with psychosocial

job ‘‘stress’’, particularly job ‘‘control’’, regardless of grade.19 Similar relationships

with job ‘‘stress’’ pertain to sickness absence from disabling regional back pain.20

The ongoing nature of Whitehall studies made it possible to take scientific advantage of a natural experiment.21 In 1988, the British government announced a major

restructuring. The Property Services Agency was to be ‘‘privatized’’ to which end its

function was ‘‘outsourced’’ in 1992. These Orwellian terms fool no one, particularly

the thousands of bureaucrats whose jobs were at risk. They realized that many of

them would be without jobs, as was the fate of 41 percent in 1992, and that employment in the private sector was predictably insecure. What they couldn’t have

foretold was that their health would deteriorate during the 3 years anticipating

‘‘downsizing’’ and sick leave would escalate. None of the trends could be ascribed

to health-adverse behavior. Impending downsizing wreaks havoc on the psychosocial

context of work inflicting ‘‘stress’’ and ‘‘strain’’ on all.22 Downsizing accelerates that

noxious, insalubrious, and lethal process we are denoting as an adverse ‘‘psychosocial’’ work context. And it does so without regard for prior station in life.

Even without the inflammatory influences of downsizing, an adverse psychosocial

context works its harm. Slowly it will deprive one of favorable ‘‘self-rated health’’

(SRH). Like socioeconomic status, SRH is a powerful predictor of all-cause mortality,

let alone the likelihood that one will seek care for regional musculoskeletal disorders.23 In a cohort of 5,001 Danish workers, adverse ‘‘psychosocial’’ work context

was shown to erode SRH over the 5 years of observation.24 A similar association

has emerged from analysis of the nurses’ health study; a perception that psychosocial work conditions were unfavorable predicted declining functional status among

some 21,000 nurses followed for 4 years.25

There are many lessons from the century of disabling regional backache.26 27 Most

germane to our discussion today, there is no ergonomic solution. Ergonomics has a

role in designing workplaces that are comfortable when we are well and accommodating when we are ill or aging. But ergonomic interventions will not decrease the

likelihood that a worker will find his or her next episode of regional musculoskeletal

pain disabling. And an ergonomic regulation of the kind recently proposed by OSHA

will certainly prove harmful: Such a regulation will medicalize the workforce; no

longer will it seem reasonable to cope with back or arm pain without demanding

remedies that, for the moment, do not exist. It will perpetuate the sophism that task

content is the culprit, and thereby inflame resentment. It will lead to task modifications that have never been shown to be helpful. And most importantly, the regulations enforce a sophistical social construction so that progress in science or policy

is impeded.

We know better.

Thank you for your attention.

Senator SPECTER. Thank you, Doctor. Turn now to Ms. Peg

Seminario, Director of the Department of Occupational Safety and

Health, AFL–CIO.
88

STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF OCCUPATIONAL SAFETY AND HEALTH, AFL–CIO

Ms. SEMINARIO. Good morning, Mr. Chairman and Senator

Landrieu. Thank you for the invitation to testify today. I am Peg

Seminario, Director of Safety and Health for the AFL–CIO.

A couple of points. Work-related musculoskeletal disorders are a

huge problem in the workplace today. We have heard the statistics

referred to earlier today, one-third of all serious workplace injuries.

The latest Bureau of Labor Statistics’ survey showed 582,000 of

these cases that were serious enough to result in time off the job.

Those come from employer reports. Those are not the AFL–CIO’s

numbers. Those are not even the Department of Labor’s numbers.

Those come from employer reports.

And I think if you talk to individual employers, they would confirm that is what they see. I believe a statement was submitted to

the record of this hearing by ALCOA by the steelworkers in

ALCOA which said that for ALCOA that one third of all of their

workplace injuries are musculoskeletal disorders. And in some sectors such as the auto industry and meat packing, it is even greater.

And what we have also found is that these numbers really underestimate the problem.

We did a comparison looking at Workers’ Compensation data and

Bureau of Labor Statistics’ data thinking that we would find more

cases on the OSHA log. What we found is there were more cases

compensable, even though the criteria for compensation are much

greater. We found twice as many cases in compensation than even

under OSHA.

So this is a huge problem for workers across the United States.

It is a huge problem for employers. And I am always struck by

coming to a forum such as this and all the work we have done over

the last 10 years that what I hear from Mr. Fellner, Dr. Bigos and

Dr. Hadler, it does not bear any relationship to the world that we

know, the workplaces we know.

There are a number of workers who have come to this hearing

today who were with us yesterday as well. These people love their

jobs. I mean, they really care about their jobs.

Cindy Wright is a nurse’s aid who was with us yesterday, suffered a very, very serious injury, rotator cuff problem, neck problem, from lifting a very heavy patient in a nursing home.

She is crushed that she cannot go back to work. This is not about

coping. She is injured. She is in pain. She needs help.

This injury could have been prevented if they had used a mechanical lifting device. But Dr. Hadler would have you believe that,

no, she just needs to cope better or she needs to like her job better.

This is not the case. These are very significant serious injuries

to workers. Again, they occur throughout all sectors of the economy. They are upper extremity problems, which as you have heard

are a particular problem for women workers.

They are problems of the low back, heavy lifting, repetition, awkward postures, vibration. We know the exposures that cause these

problems. And what we have seen is that when employers put in

place programs that evaluate these hazards, reduce exposure, yes,

indeed, we see reductions in injuries. That is what we see. That is

the real world.
89

You can talk about whether there is consensus on this. Clearly

as you have heard this morning there is not. But we would agree

with Senator Specter that if we had waited for consensus on

whether asbestos caused cancer, whether benzine caused leukemia,

whether cotton dust caused byssinosis, we would still have workers

in this country dying and being exposed today of these very, very

serious hazards. And so there may not be consensus but there is

evidence.

I think if the committee looks at the reports of the National

Academy of Sciences done in 1998, the recent report concluded in

2001, you will see that they are very comprehensive documents

that involved a lot of folks, a lot of experts. The experts in the

country, over 50 experts involved in the developments of those reports, they came to some very firm conclusions. And we would encourage you to look at those conclusions.

Let me just say that there are approaches to dealing with these

problems which we will talk about later today, but just to make the

point that these are very real injuries. They are significant injuries.

They disable a lot of workers in this country.

PREPARED STATEMENT

This problem really needs a national response. And we are glad

that Senator Specter is having this hearing to examine this issue

so completely and that both Senator Landrieu and Senator Specter

are on legislation directing the Department of Labor to issue a

standard. Thank you.

[The statement follows:]

PREPARED STATEMENT OF PEG SEMINARIO

Mr. Chairman, members of the committee, my name is Peg Seminario. I am Director of Safety and Health for the AFL-CIO, a federation of 65 national and international unions representing 13 million working men and women and their families.

I appreciate the opportunity to testify at this special hearing on ergonomics and to

present our views on why an OSHA ergonomics standard is urgently needed to protect workers in this country.

The AFL–CIO has a long and deep interest and involvement in the ergonomics

issue. Musculoskeletal disorders (MSDs) caused by exposure to ergonomic hazards

are a major safety and health problem for our members and for all workers. In all

economic sectors and in most industries, musculoskeletal disorders are the major

source of workplace injury and illness. Workers in meatpacking, poultry, auto assembly, nursing homes, transportation, warehousing, construction, agriculture and

data entry are among those at risk.

For more than two decades, unions have been working hard to prevent these injuries through research, joint efforts with employers, union training programs, and by

requesting OSHA enforcement actions under the general duty clause.

Since the late 1980’s, we have been seeking an OSHA standard to prevent unnecessary musculoskeletal disorders and to control ergonomic hazards. It has been ten

years since former Secretary of Labor Elizabeth Dole committed the Department of

Labor to ‘‘taking the most effective steps necessary to address the problem of ergonomic hazards on an industry-wide basis’’ and to develop an ergonomics standard.

But, due to fierce industry and political opposition to any mandatory ergonomics

standard, today workers have no legal protection against these hazards. During the

past decade millions of workers have suffered unnecessary injury, illness and disability while an ergonomics standard has been delayed. More than 4,900 workers

are injured each day that protections are further delayed. Since the OSHA

ergonomics standard was repealed on March 21, 2001, more than 170,000 workers

have suffered work-related musculoskeletal disorders.
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WORK-RELATED MUSCULOSKELETAL DISORDERS ARE THE NATION’S LEADING JOB SAFETY

PROBLEM

Work-related musculoskeletal disorders are the leading type of occupational injury

and illness in America today. These disorders include upper extremity disorders

such as carpal tunnel syndrome, tendinitis, tenosynovitis, and rotator cuff injuries,

and disorders of the low back.

The Bureau of Labor Statistics (BLS) reports that over 582,000 musculoskeletal

disorders involving days away from work were reported by private sector employers

in1999, accounting for more than one in three of all injuries and illnesses involving

recuperation away from work. (Appendix A) The National Academy of Sciences, in

its January 2001 report, found that approximately one million people lose time from

work each year due to musculoskeletal disorders.

While the total number of lost-time MSDs reported by the Bureau of Labor Statistics has declined since 1992, the problem of workplace MSDs is still great. Despite

the downward trend in total numbers of reported cases, MSDs have consistently accounted for more than one-third of total lost worktime cases since 1992. More disturbing, the downward trend seems to be reversing in some areas. According to the

most recent BLS survey, the rate of injuries associated with repetitive motion rose

from 1998 to 1999 in every industrial sector except finance, and increased over 9

percent nationally. The rate of injuries caused by overexertion increased in construction and mining in 1999, and the rate of illnesses caused by repeated trauma increased from 14.8/10,000 workers to 17.6/10,000 workers in transportation.

These large numbers of injuries reported by the BLS and NAS, however, do not

represent the total scope of the problem. These cases represent only those injuries

and illnesses which result in more than one day of lost time from work. Based upon

the ratio of non-lost work-time injuries to lost work-time injuries which occur in the

workplace, (2 to 1), the Department of Labor has estimated that a total of 1.8 million MSDs are reported by employers to the Bureau of Labor Statistics each year.

But even this number understates the magnitude of the problem. The BLS survey

only reports injury and illness data for the private sector. The injury experience of

the more than 16 million state, county and local public sector workers, and 2.8 million Federal sector workers, including postal workers, is not reflected in the survey

(Employment and Wage Annual Averages, 1997, BLS, 1998). While comprehensive

and detailed injury data for these groups of workers is not collected, the data that

is available shows that MSDs are a major problem for these workers as well. For

the 28 states and territories where injury and illness data is collected for state and

local public employees, in 1998, the BLS reported 63,374 musculoskeletal disorders

that resulted in lost work days.

There is also extensive evidence that the BLS survey understates the extent of

the MSD problem for private sector workers. More than 16 studies submitted to the

record of OSHA’s rulemaking on ergonomics demonstrated significant under recording and under reporting of workplace injuries. Based on this evidence OSHA found

that ‘‘that for every reported MSD, another MSD goes unreported. Thus, the total

number of work-related MSDs estimated by OSHA to occur in the United States annually is 3.6 million.’’ (OSHA, 2000) This estimate does not include MSDs suffered

by state, local or Federal employees.

A comparison of data from the BLS survey, workers’ compensation data and surveillance data for several states confirms that the BLS data under-represents the

extent of work-related MSDs. A review by the AFL-CIO of available BLS data and

state workers’ compensation data on musculoskeletal disorders for three states—

Massachusetts, Oregon and Washington—for a several year period in the 1990’s

found that the numbers of cases of MSDs reported to BLS were significantly less

than the number of MSD cases accepted for workers’ compensation—in many instances 50 percent less. These differences are even more significant since the criteria for compensation are much more restrictive than the recording and reporting

criteria under the BLS survey (i.e. compensation for MSDs required 4 or 5 days off

the job, compared to one day of lost time for reporting to BLS). See Appendix B.

Recent studies have demonstrated that only a small percentage of workers suffering from work-related back injuries, carpal tunnel syndrome and other musculoskeletal disorders are filing workers’ compensation claims for these injuries. A study

published in the January 2000 ‘‘Journal of Occupational and Environmental Medicine’’ found that only 25 percent of the group of Michigan auto workers studied with

diagnosed work-related musculoskeletal disorders filed for workers’ compensation

(Rosenman et al, 2000). A similar study of Connecticut workers found that only 10

percent of workers with musculoskeletal disorders filed workers’ compensation

claims (Morse et al, 1999).
91

Based upon these studies, it appears that the under reporting of MSDs may be

far greater than found by OSHA in its ergonomics rulemaking and the true magnitude of work related MSDs far greater than 3.6 million cases a year.

Work-related MSDs are among the most severe injuries facing American workers.

The BLS reports that among major disabling injuries and illnesses, median days

away from work are highest for carpal tunnel syndrome (27 days). This is significantly higher than the median days away from work for fractures or amputations.

While MSDs occur in every sector and industry across the economy, some sectors

have been hit harder than others. Over one quarter of all MSDs involving time

away from work occur in the service sector and over one quarter in manufacturing.

Nursing aides, orderlies, and attendants, along with registered nurses, accounted for

almost 10 percent of all lost time work-related MSDs in the U.S. in 1999. Sixty-five

percent of injuries and illnesses involving days away from work for nursing aides,

orderlies and attendants are due to sprains and strains, while 60 percent of Registered Nurses’ injuries and illnesses are due to sprains and strains.

BLS data show that for many types of MSDs involving the upper extremities, including carpal tunnel syndrome, women workers suffer a disproportionate number

of injuries. In 1999, women suffered 67 percent of reported carpal tunnel syndrome

cases (18,651) and 61 percent of reported tendinitis cases (10,127) even though

women comprise about 46 percent of the workforce and accounted for 33 percent of

total workplace injuries (BLS, 1999). As with other musculoskeletal disorders, the

number of cases of carpal tunnel syndrome, tendinitis and other repetitive motion

injuries reported by BLS understates the extent of the problem found among these

workers.

Workers in meat packing plants have a repetitive trauma disorder incidence rate

of 912 per 10,000 full time workers. Motor vehicle and car bodies have a rate of

685.5 and numerous textile and apparel sectors have rates exceeding 200.

Ergonomic hazards are also a significant problem for workers in construction,

maritime and agriculture. These sectors should be covered by an OSHA ergonomics

standard just as they are currently covered by standards in the states of California

and Washington. According to the BLS survey, in 1999 there were 52,800 reported

cases of lost-time injuries resulting from overexertion and repetitive motion in these

sectors. These types of injuries accounted for 23 percent of all reported lost worktime injuries in construction, 21 percent of reported lost time injuries in maritime

(SIC Codes 44 and 373), and 18 percent of reported lost work-time injuries in agriculture. A large percentage of construction workers suffer from back injuries, shoulder injuries and other musculoskeletal disorders.

THE TOLL OF MUSCULOSKELETAL DISORDERS ON WORKERS AND THE ECONOMY IS GREAT

Musculoskeletal disorders are painful, disabling, costly injuries. According to the

National Academy of Sciences, a conservative estimate of the costs imposed by

MSDs on the American economy is between $45 and $54 billion every year (NRC/

IOM, 2001). These figures only include the actual monetary losses that result from

MSDs, but do not account for the enormous pain, suffering and disability that these

preventable disorders cause.

The pain and toll of these injuries was described by dozens of injured workers who

testified at OSHA’s ergonomic hearings on why a standard was so important—workers like Ron Kline, an auto worker from Maryland, Carol Py, a clerk typist from

Pennsylvania and Nancy Foley a newspaper reporter from Massachusetts, all who

developed serious work-related MSDs.

‘‘Starting with my right elbow, the illness became so severe, I could not lift the

air gun. As this was occurring, my reaction was to start using my left hand to complete my assignment.

‘‘As the pain worsened, even with local treatment from the dispensary, it required

surgery.

‘‘The time away from work for my right arm required 13 weeks away from work

with less than complete recovery, leaving me with 15 percent permanent loss of full

use of my right arm.

‘‘I also endured one year of physical therapy for my right arm.

‘‘Subsequently, I required surgery on my left arm with seven weeks away from

work.’’ (Oral testimony of Ron Kline at OSHA Ergonomics Hearings, Tr. 7950)

‘‘I developed cumulative trauma disorder which is like multiple muscular injuries

due to repetitive motion, DeQuervains disease in my thumb here, cubital tunnel

syndrome which is the ulnar nerve, compression of the ulnar nerve the elbow and

trigger finger.
92

‘‘During the next 12 months, the pain in my hand was so unbearable that I had

to have repeat surgery on my right hand. I have trouble turning the pages. I never

returned to work as my medical restrictions were so limited that my company could

not find me a job.

‘‘Last year, I had surgery on my other hand because my thumb would not move.

‘‘Today, I have difficulty driving, cleaning, cooking, and food shopping. And my

husband, he mostly does all my shopping for me. And my grandchildren do a lot

of the cleaning for me, too. The yard work is out of the question since I cannot rake

or mow the lawn. I had to give up the things that I used to love like sewing and

gardening. Before I was injured, I even had a green belt in karate. My arms are

so weak now that I can barely take care of my three grandchildren.’’ (Oral testimony

of Carol Py at OSHA Ergonomics Hearings, Tr. 6321–6322).

‘‘By the time I left the newspaper I was so severely injured that my recovery has

been very slow. I may never fully recover. I live with chronic pain every day. Sitting

still triggers pain. I have trouble carrying groceries into my house and doing simple

housekeeping tasks. I am trying to retrain to be a school teacher, but my injuries

make the retraining difficult. I do my school work by lying in bed and talking into

a voice-activated computer.

‘‘I loved my job. I remember thinking how lucky I was to have a job that was so

much fun. It was a great disappointment to me to have to give it up...I have suffered

from severe depression as a result of losing my career and living with chronic pain.

I have lost thousands of dollars in income. I had hoped to have children some day,

but I cannot pick up and carry my eight-month old niece.’’ (Oral testimony of Nancy

Foley at OSHA Ergonomics Hearings, Tr. 7321–22).

The pain and disability caused by musculoskeletal disorders is widespread. Dr.

Robin Herbert of the Mt. Sinai Medical Center, an occupational physician who testified at the OSHA’s ergonomics hearings reported that 25 percent of her patients

with musculoskeletal disorders have permanent disabilities, and of those 25 percent,

ten percent are never able to return to work (Oral testimony at OSHA Ergonomics

Hearings, Tr. 1736–37). Preliminary results of one study showed that 15 percent of

all patients with MSDs of the upper extremities are characterized as disabled (Oral

testimony at OSHA Ergonomics Hearings, Tr. 1738). In New York State, between

1993–1995, 86 percent of workers with carpal tunnel syndrome were deemed to be

permanently disabled by workers’ compensation judges (Herbert, 1999). A study of

workers’ compensation claims for ergonomic injuries in North Carolina found that

19.4 percent of the injuries resulted in permanent partial disability; 22 percent of

the claimants were unable to return to work (Waldorf and Snow, 1996).

The financial and social consequences of these injuries on workers are significant.

Many injured workers receive no workers’ compensation. Their injuries and disabilities destroy or severely limit their ability to make a living. Financial burdens created by these injuries result in workers losing their homes, cars and health insurance. Injured workers are often unable to lead a normal life experiencing great difficulty performing routine activities such as writing, cleaning, caring for children,

bathing and driving a car. The effects of these injuries on injured workers’ wellbeing is also significant. Workers suffering MSDs report higher levels of depression,

anxiety and stress at home.

THE SCIENTIFIC EVIDENCE IN SUPPORT OF AN ERGONOMICS STANDARD IS EXTENSIVE

AND STRONG

A broad, extensive, and overwhelming body of scientific evidence firmly establishes that musculoskeletal disorders are caused by exposures to workplace ergonomic risk factors—force, repetition, awkward postures and vibration. This conclusion is strongly supported by evidence obtained from epidemiological studies of

worker populations, laboratory findings, and the clinical experience of physicians

and health care professionals.

Three recent authoritative and comprehensive reviews of the scientific literature

conclude that exposure to ergonomic hazards in the workplace causes musculoskeletal disorders. These are a 1997 report by the National Institute for Occupational Safety and Health, ‘‘Musculoskeletal Disorders and Workplace Factors,’’ and

two congressionally-mandated reports by the National Academy of Sciences, ‘‘WorkRelated Musculoskeletal Disorders,’’ completed in 1999, and ‘‘Musculoskeletal Disorders and the Workplace,’’ completed in 2001.

In evaluating the extensive body of scientific literature, comprising over 800 research studies and references, the January 2001 NAS report concluded that:
93

—‘‘The panel’s review of the research literature in epidemiology, biomechanics,

tissue mechanobiology, and workplace intervention strategies has identified a

rich and consistent pattern of evidence that support a relationship between the

workplace and the occurrence of MSDs of the lower back and upper extremities.’’

—‘‘The basic biology and biomechanics literatures provide evidence of plausible

mechanisms for the association between musculoskeletal disorders and workplace physical exposures.’’

The research literature has identified the biomechanical risk factors in the workplace that pose a hazard to workers of developing a musculoskeletal disorder affecting the lower back and upper extremities. Workplace biomechanical risk factors that

can cause MSDs include force, repetition, vibration, awkward postures, and heavy

lifting. As the 2001 NAS report summarized:

—‘‘The panel concludes that there is a clear relationship between back disorders

and physical load; that is, material handling, load movement, frequent bending

and twisting, heavy physical work, and whole-body vibration. For disorders of

the upper extremities, repetition, force and vibration are particularly important

work-related factors.’’

—‘‘Low back disorder risk has been established through epidemiological studies

of work that involves heavy lifting, frequent bending and twisting, and whole

body vibration, as well as other risk factors.’’

—‘‘The pattern of evidence for upper extremity disorders, as for the low back, also

supports an important role for physical factors, particularly repetition, force and

vibration.’’

As noted above, the 1998 and 2001 National Academy of Sciences studies on workrelated musculoskeletal disorders were the result of Congressional requests for a review of the scientific evidence on work-related musculoskeletal disorders. Both of

these reviews concluded that there is a strong body of evidence that musculoskeletal

disorders are associated with exposure to workplace ergonomic risk factors and that

there are effective interventions to reduce the risk of these disorders. The Congress

and the Bush Administration should endorse these findings and support the

issuance of a new ergonomics standard to protect workers.

AN OSHA ERGONOMICS STANDARD IS NEEDED TO PROTECT WORKERS FROM

MUSCULOSKELETAL DISORDERS

The key finding motivating Congress to enact the Occupational Safety and Health

Act in 1970 was the fact that ‘‘personal injuries and illnesses arising out of work

situations impose a substantial burden upon, and are a hindrance to, interstate

commerce in terms of lost production, wage loss, medical expenses, and disability

compensation payments,’’ 29 U.S.C. § 651(a). The purpose of the Act was to assure

so far as possible every working man and woman in the nation safe and healthful

working conditions and to preserve the country’s human resources.

As the major source of job injury and illness in the nation today costing more than

$45–$50 billion a year, work-related musculoskeletal disorders are precisely the type

of problem that the Act was intended to address. Just as the Congress acted in 1970

and passed the Occupational Safety and Health Act to address the high toll and cost

of workplace injuries and illnesses, it is imperative that OSHA promulgate an

ergonomics standard to address the toll and cost of musculoskeletal disorders.

The severity of the problem of MSDs and the need for government action was recognized more than 10 years ago by Secretary of Labor Elizabeth Dole when she committed to taking the most effective steps necessary to address the problem of ergonomic hazards. The need for such action was reaffirmed in 1992 by Secretary of

Labor Lynn Martin when she initiated rulemaking on an OSHA ergonomics standard in response to a petition from the United Food and Commercial Workers, AFL–

CIO and many unions.

Unfortunately ideological opposition to government action by industry groups and

some in Congress has delayed and blocked these needed protections. More than 10

years after government action was promised, workers still lack legal protection

against ergonomic hazards.

In the aftermath of the recent action by Congress and the Bush Administration

to repeal OSHA’s November 2000 ergonomics standard, Secretary of Labor Elaine

Chao committed the Department of Labor to developing a comprehensive approach

to address musculoskeletal disorders. The AFL-CIO supports and has long advocated a comprehensive approach to addressing MSDs. But any approach to addressing MSDs must have as its core and foundation a mandatory protective OSHA

standard. Voluntary compliance assistance, outreach, education and further research can and should complement and supplement regulatory action. But voluntary
94

approaches alone are insufficient to provide workers the protection they need and

deserve.

Indeed, the major advances in protecting workers from MSDs and implementation

of workplace ergonomic programs have come as a result of mandatory action required by OSHA enforcement under the general duty clause. Ergonomic programs

in auto manufacturing, meatpacking, poultry, and garment industries all have their

roots in the settlement agreements that stemmed from OSHA enforcement actions.

It is necessary and appropriate to extend these same protections by regulation to

all sectors and workplaces where workers face a significant risk of musculoskeletal

disorders.

The AFL–CIO has long advocated that an OSHA ergonomics standard be based

on the good employer practices that have been demonstrated to be effective at reducing the incidence and severity of work-related MSDs. As the National Academy of

Sciences (NRC/IOM, 2001) and General Accounting Office (GAO, 1997) have both reported, these effective practices implement ergonomic principles and follow a programmatic approach which includes employer commitment and employee participation, job analyses and control, training and medical management.

These basic elements form the foundation of OSHA’s 1990 Meatpacking Guidelines and settlement agreements that have been implemented successfully in key industries. These basic elements also form the basis of many employer ergonomic programs that have been effective at reducing MSDs. They also form the basis of the

voluntary standard on MSDs which is being developed by the Z 365 ANSI standard

setting committee. These basic elements were also the backbone of the November

2000 ergonomics standard issued by OSHA.

To be effective at preventing injuries and consistent with the OSHAct, the AFL–

CIO believes that an OSHA ergonomics standard should also do the following:

—Cover all sectors and all workers at significant risk of injury. OSHA’s November

2000 ergonomic standard was limited to general industry and excluded construction, maritime, agriculture and railroads. MSDs are a major source of injury and illness for workers in all sectors. State ergonomic standards in California and Washington apply to all employers and workers. Any Federal OSHA

ergonomics standard should cover workers in all sectors as well.

—Be pro-active and preventive. OSHA’s November 2000 standard was triggered

only in response to worker reports of MSD injuries or persistent symptoms,

when workers also had significant exposure to identified ergonomic risk factors.

In the absence of any injury, no action was required, even if the employer had

knowledge that serious hazards were present. All other OSHA standards are

triggered by worker exposure to hazards, not reports of injuries. To be preventive an ergonomics standard should respond to hazardous exposure, whether or

not an injury has occurred.

—Provide for early detection of MSDs and early intervention. MSDs are cumulative progressive injuries that become more serious, disabling and costly with

continued exposure. One of the keys to a successful ergonomics program is the

early detection of these injuries, so interventions can be made before damage

is serious and permanent. Early detection and intervention is also key to reducing the cost of these injuries.

—Encourage reporting of MSDs and hazards and participation by workers and

their representatives. The early detection of MSDs is only possible if workers

feel free to report MSDs and MSD hazards. Any standard must prohibit discrimination and retaliation against workers who make such reports and prohibit practices or policies that discourage worker reports. Such provisions were

appropriately included in OSHA’s ergonomics standard. To encourage early reporting and participation in any medical management program, employees

should not have to face loss of wages for making these reports. This was the

purpose of the work restriction protection provision of OSHA’s ergonomics rule.

The standard mandated that an employer follow a health care provider’s medical determination for job restriction of injured workers. It also provided that

on a temporary basis when such restrictions were required, workers should not

have to lose wages or benefits.

This work restriction protection was not a workers’ compensation system. It’s

purpose was to encourage early reporting, not after the fact compensation. It,

in no way changed or altered workers’ compensation laws or benefits. Similar

provisions have been included in OSHA standards since 1978 when medical removal protection was included in OSHA’s lead standard. Such provisions have

been upheld by reviewing courts as permissible and appropriate protective

measures under the OSHAct. Such a provision should be included in an OSHA’s

ergonomics standard.
95

—Provide for the reduction of exposure to ergonomic hazards to the extent feasible. The reduction of exposure to ergonomic risk factors—force, repetition,

awkward posture, and vibration—must be the heart of any ergonomics standard, just as it is the heart of all OSHA standards. An ergonomics standard must

require employers to reduce exposures to ergonomic risk factors so they no

longer pose a hazard, or if that is not possible, reduce them to the extent feasible.

As stated earlier, some employers have already taken action and implemented

measures similar to those outlined above to protect workers. Many countries around

the globe have implemented ergonomic standards or manual handling standards.

These include British Columbia, Canada, Australia, Sweden and the member states

of the European Community which have adopted regulations to implement the European Community directive on manual handling (Council Directive 90/269/EEC,

May 29, 1990) and directive on video display terminal use (Council Directive 90/270/

EEC, May 29, 1990).

The only reason why a mandatory ergonomics standard is not in place in the

United States today is because of the fierce ideological opposition by some business

groups, including the U.S. Chamber of Commerce and the National Association of

Manufacturers, and others to any government intervention on this issue.

For 10 years these business groups have opposed any and every attempt to regulate ergonomics at the state and Federal level. They opposed state standards in

California, North Carolina and Washington. They opposed efforts by states and Federal OSHA to enforce against ergonomic hazards under the general duty clause.

They are now challenging longstanding OSHA regulations that require musculoskeletal disorders to be recorded on the OSHA log. They are even trying to block

a voluntary ANSI standard on MSDs that is now close to being finalized.

The misrepresentation by these groups of the facts and the science and their

fierce opposition to any ergonomic protections is directly responsible for the serious

and preventable injury to millions of workers in this country. Unfortunately this

past March, a majority in the Congress and President Bush decided to side with

these opponents of protections and acted to repeal OSHA’s ergonomics standard.

We believe that it is time that Congress, elected to be the people’s representatives,

and the Bush Administration started doing the people’s business. The Department

of Labor should act immediately to issue—and the Congress should support—a new

ergonomics standard to protect the working men and women of this country.
96
97

APPENDIX B—MSD DATA COMPARISON FROM THREE STATES

WORK-RELATED CARPAL TUNNEL SYNDROME IN MASSACHUSETTS

[Massachusetts SENSOR Program vs. Massachusetts BLS, 1993–1996]

Year

Massachusetts SENSOR

CTS cases reported by

Massachusetts BLS

All workers

compensation

cases

Additional

physician reported only

cases

Total unique

SENSOR cases

1993 ............................................................................................... 1,076 281 1,357 379

1994 ............................................................................................... 1,156 185 1,341 627

1995 ............................................................................................... 885 86 971 321

1996 ............................................................................................... 915 104 1,019 431

Source: The Commonwealth of Massachusetts, Executive Office of Health and Human Services, Department of Public Health, January 20,

1999.

MUSCULOSKELETAL DISORDERS IN OREGON

[Number of Injuries by Event that Caused the Injury, 1992–1994]

1992 1993 1994

WC 1 BLS 2 WC BLS WC BLS

Repetitive Motion .......................................................................... 545 950 1,038 857 1,521 1,156

Overexertion .................................................................................. 12,325 7,966 11,786 7,752 11,697 7,315

Total ................................................................................ 12,870 8,916 12,824 8,609 13,218 8,471

1 There are time-loss-claims with 4 or more days away from work. Private insurers accounted for 49 percent of the claims, the SAIF Cor- poration for 31 percent, and self-insured companies for 20 percent. 2 Number of private industry nonfatal occupational injuries and illnesses involving three or more days away from work. Days-away-from-work cases include those which result in days away from work with or without restricted work activity.

Source: BLS State data for 1992, 1993, 1994 and ‘‘Oregon Workers’ Compensation Characteristics Calendar Year 1995,’’ Research & Analysis Section, Oregon Department of Consumer & Business Services, June 1997.

MUSCULOSKELETAL DISORDERS RESULTING FROM OVEREXERTION IN WASHINGTON STATE

[Industrial Insurance Claims vs. BLS Data, 1992–1994]

Year

BLS data 1 Industrial insurance claims 2

1 or more

days away—

overexertion

3 or more

days away—

overexertion

Total # MSD 3

claims—overexertion

Total # timeloss MSD

Claims 4—

overexertion

1992 ............................................................................................... 17,107 13,258 48,019 21,575

1993 ............................................................................................... 16,488 12,514 46,970 20,578

1994 ............................................................................................... 14,345 11,046 45,747 19,768

1 Reflects both State fund and Self Insured employers.

2 The term claims refers to accepted claims only. Data reflects both State fund and Self Insured employers.

3MSDs can include strains/sprains, joint inflammation, lower back pain and nerve compression syndromes. 93 percent of all MSD claims were coded overexertion. 4Washington State defines time loss claims as those claims with 4 or more days away from work and includes claims where the employee is kept on salary, has loss of earning power or provisional time loss.

Source: ‘‘Work-Related Musculoskeletal Disorders: Washington State Summary 1992–1994,’’ State of Washington Dept. of Labor and Industries, Oct. 1996 and data from the State of Washington Dept. of Labor and Industries, Jan/Feb 1999.

Senator SPECTER. Thank you very much. Dr. Bradley Evanoff of

Washington University School of Medicine.

STATEMENT OF DR. BRADLEY EVANOFF, ASSISTANT PROFESSOR OF

MEDICINE, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

Dr. EVANOFF. Mr. Chairman, Senator Landrieu, as a general internist and occupational health physician, I diagnose and treat patients with both work-related and nonwork-related illnesses and

carry out research on musculoskeletal disorders. Thank you for the
98

opportunity to address the committee today. I will attempt to answer the specific questions which are posed to our panel.

What types of injuries occur? The term musculoskeletal disease

is not a single diagnosis but represents a group of well-recognized

injuries and diseases which affect the bones, joints, muscles, tendons, and nerves. Examples of these conditions include hand/wrist

tendonitis, epicondylitis, low back pain, and carpal tunnel syndrome.

Specific objective criteria exists for the diagnosis of these musculoskeletal disorders. For example, the American College of Occupational and Environmental Medicine has issued practice guidelines containing specific diagnostic criteria from more than 50 distinct musculoskeletal disorders which may be related to work.

These diagnoses are based on patients’ symptoms and on physical examination findings by a treating clinician, and when appropriate, laboratory and radiographic tests. Musculoskeletal disorders

are routinely diagnosed by physicians all over the world.

Who suffers these injuries? Musculoskeletal disorders are seen in

a variety of patients and have a variety of causes. Factors such as

age, gender, and coexisting diseases all influence the probability

that a person will suffer from an MSD. However, workplace exposures are among the most important determinants of musculoskeletal disorders in many working populations.

Physicians who evaluate working people with a musculoskeletal

disorder routinely evaluate whether their patient’s condition is

work-related or not by considering both work- and nonwork-related

factors. In evaluating work relatedness, physicians can rely on a

large body of literature showing that certain musculoskeletal disorders are seen much more frequently in workers whose jobs involved repeated forceful use of the hands and arms, repeated heavy

lifting or bending of the back, or exposure to vibration.

When taken as a whole, the medical literature shows that increased exposure to these physical factors is associated with a

greater risk of an injury.

Worker groups at increased risk include nurses and nurses’ aids,

garment workers, construction workers, meat packers and other

food processing workers, and workers in manufacturing and agriculture.

How many suffer MSDs and what is their severity? Musculoskeletal disorders are clearly the most common group of occupational diseases and injuries and account for the majority of lost

time, lost productivity and workers’ compensation costs.

Data from the Bureau of Labor Statistics indicate that there are

almost 600,000 lost workday cases due to repetitive trauma and

overexertion annually. The National Academy of Sciences estimates

that almost 1 million lost workday cases occur annually.

It is important to know that these figures are underestimates.

They do not include cases for which no lost workdays occurred. And

a number of studies show that employers and workers routinely

under report the occurrence of these disorders.

Musculoskeletal disorders represent an enormous burden to our

country in terms of lost productivity and personal suffering. Conservative estimates of national costs for musculoskeletal disorders

are around $50 billion annually.
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The National Academy of Sciences estimated that the cost may

exceed 1 percent of our gross domestic product.

The personal cost to workers are much harder to quantify. Many

of my patients are unable to perform not only work duties but simple daily activities such as carrying groceries, opening a jar or lifting a child. While many patients recover quickly from these disorders, others have prolonged disabilities.

PREPARED STATEMENT

In summary, musculoskeletal disorders are commonly accepted

conditions which can be confidently diagnosed. The personal and

economic costs of this disorders are high, and workplace physical

exposures are a prominent and preventable risk factor.

In my opinion, an adequate scientific basis exists to support a

standard. Thank you.

[The statement follows:]

PREPARED STATEMENT OF DR. BRADLEY EVANOFF

My qualifications to testify: I am a physician and researcher with over ten years

of experience in treating and studying occupational musculoskeletal disorders

(MSDs). I am currently an Assistant Professor of Medicine at Washington University School of Medicine, where I am Chief of the Division of General Medical

Sciences and the Richard and Elizabeth Henby Sutter Chair of Occupational, Industrial, and Environmental Medicine. As a medical researcher, I have published more

than two dozen peer-reviewed journal articles, dealing primarily with the diagnosis

and treatment of musculoskeletal disorders and the prevention of work-related injuries. I have also presented findings of my research at numerous scientific meetings,

and have served as the chairperson of sessions at scientific meetings devoted to the

prevention of occupational musculoskeletal disorders. I serve as a reviewer for several medical and public health journals. I have been involved in the national debate

concerning ergonomics and work-related musculoskeletal disorders through my participation as an invited speaker at the 1998 National Academy of Sciences meeting

on ‘‘Work-Related Musculoskeletal Disorders: A Review of the Evidence.’’ I have also

served as a member of the American National Standards Institute, Accredited

Standards Committee on Control of Cumulative Trauma Disorders.

My interests in musculoskeletal disorders were shaped by my clinical experiences

in treating injured workers. I was originally interested in occupational cancer research, but as I spent more time in the field of occupational health, I realized that

musculoskeletal disorders were by far the largest preventable cause of morbidity

and disability among the working populations which I treated. As a treating physician, I diagnose and treat patients every week who have work-related musculoskeletal problems such as back pain, tendonitis, and carpal tunnel syndrome. Over

the course of my career, I have treated several thousand workers with musculoskeletal disorders related to their work. Many of these disorders could have been

prevented or subsequent disability reduced through better job design and more

timely medical treatment which took work factors into account.

I feel that I am fortunate to be involved in many aspects of work-related musculoskeletal problems—I treat individual workers, I advise employers on programs to

prevent musculoskeletal problems, and I engage in research on the causes of these

disorders and the effectiveness of interventions aimed at reducing their number and

severity. There is no question that a great deal of suffering, job displacement, and

economic loss is due to musculoskeletal disorders. It is also clear that many of these

disorders are preventable, and that appropriate action can reduce this disease burden.

I have based my opinions on my professional background and training, which includes clinical experience treating patients with MSDs, research experience in performing and analyzing studies of work-related MSDs, and work on intervention programs to reduce MSDs in working populations. Based on the existing scientific evidence and my own professional experiences, I conclude that there is strong evidence

that certain work exposures are causally related to carpal tunnel syndrome,

tendonitis, back pain, and other MSDs among workers. This conclusion takes into

account the strengths and limitations of existing studies, including issues of confounding, bias, and research design. The existing research base is also consistent
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with my clinical experience, where I have seen thousands of workers with clinically

diagnosed musculoskeletal disorders associated with the same physical risk factors

described in the scientific literature. Existing research and my own clinical and administrative experiences have demonstrated that ergonomic interventions can prevent injuries in a cost-efficient manner, and that improved medical treatment programs can prevent disability from work-related MSDs.

ADEQUATE SCIENTIFIC AND CLINICAL BASIS EXISTS TO SUPPORT AN ERGONOMICS

STANDARD

The workforce of our nation incurs a large number of musculoskeletal illnesses

and injuries which are caused by or related to workplace exposures. Many of these

disorders are preventable. Both my academic and my clinical experiences indicate

that MSDs can be reliably diagnosed using accepted clinical guidelines, that a substantial proportion of MSDs are related to exposure to workplace physical factors,

and that a significant part of this burden is preventable.

Acute and chronic work-related musculoskeletal disorders (MSDs) affect an estimated 19 million persons per year in the United States and account for the majority

of workers’ compensation costs nationwide (Bernard 1997, Webster and Snook 1994).

Over the past two decades, there has been considerable evidence presented in the

scientific and medical literature which supports a causal relationship between work

activities and musculoskeletal disorders, including back pain, carpal tunnel syndrome, and tendonitis. The available literature when taken as a whole strongly supports the presence of a causal association between exposure to certain workplace

physical activities and the development of specific MSDs. The actions of health and

safety professionals all over the country reflect the knowledge that workplace exposures should be reduced in order to reduce injuries and disability.

The evidence for a causal association between work exposures and musculoskeletal disorders has been well summarized by researchers at the National Institute for Occupational Safety and Health (Bernard 1997) as well as by international

scientific panels and by regulatory agencies in other countries. (Kourinka and

Forcier 1995) The National Academy of Sciences convened a multidisciplinary international expert panel in 1998 to review available evidence on work-related musculoskeletal disorders. I was one of the invited participants in this process. After thorough review of available scientific evidence, including conflicting points of view, the

National Academy of Sciences concluded that musculoskeletal disorders were a

major source of disability and economic loss, that workplace physical exposures were

an important cause of these disorders, and that interventions to reduce workplace

physical exposures could reduce the number of musculoskeletal disorders. Multiple

expert panels and individual scientists reviewing the scientific evidence have arrived at these same conclusions, as has a second review completed by the National

Academy of Sciences, released earlier this year.

The conclusions of this second panel report by the National Academy of Sciences

unambiguously support important arguments in favor of an ergonomics standard.

The panel found strong and consistent evidence from both epidemiologic studies and

biomechanical studies to support a relationship between workplace physical exposures and the occurrence of MSDs of the low back and upper extremities. The panel

found that existing research demonstrated the effectiveness of appropriate ergonomic interventions in reducing the risk of low back pain and upper extremity

symptoms. The panel found that work-related musculoskeletal disorders are a major

source of costs and morbidity, and that some of this burden to society and to individuals is preventable.

A number of non-governmental groups have taken actions based on the evidence

available. After concluding that sufficient evidence existed to promote a standard intended to protect worker health and safety, the American Conference of Governmental Industrial Hygienists (ACGIH) recently announced exposure limits for physical exposures in order to reduce musculoskeletal disorders. The ACGIH is a respected and authoritative non-governmental body which publishes exposure limits

for chemical and physical hazards which are widely used in industry. The American

College of Occupational and Environmental Medicine has published practice guidelines which clearly link workplace physical exposures to musculoskeletal disorders.

The American National Standards Institute has a committee charged with creating

a national industrial standard to reduce work-related musculoskeletal disorders.

These and other groups have acted because of the scientific evidence showing that

MSDs are a serious problem, that workplace exposures are related to many MSDs,

and that the risk of harm to employees can be diminished by reduction in physical

exposures.
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My own reviews of the scientific literature (Evanoff 1999, Evanoff and Rempel

1998) have found that musculoskeletal disorders have been studied in a variety of

work settings. Numerous studies have shown that higher rates of these disorders

are seen among workers whose jobs demand repetitive or forceful movements, or

who are subject to vibration or prolonged awkward postures. Systematic review of

the medical and scientific literature shows that there is evidence of a causal relationship between work factors and carpal tunnel syndrome, tendonitis of the hand

and wrist, epicondylitis, neck disorders, shoulder disorders, and low back disorders.

Opponents of an ergonomics standard have attacked the scientific basis of the

standard by suggesting that MSDs do not represent ‘‘objectively’’ diagnosed entities,

and consist only of worker-reported aches and pains. On the contrary, most MSDs

fall into well recognized and commonly accepted diagnostic classifications which utilize both symptoms and specific signs detected on physical examination by a health

care provider. It must be recognized that ‘‘MSD’’ is not a diagnosis itself, but a term

used to group many different diagnoses affecting different body parts. For example,

the practice guidelines promulgated by the American College of Occupational and

Environmental Medicine list ‘‘Diagnostic Criteria’’ for more than fifty separate musculoskeletal disorders. These conditions include such diagnoses as lateral and medial epicondylitis, ulnar and radial nerve entrapment, shoulder impingement, rotator cuff tear, wrist tendonitis/tenosynovitis, DeQuervain’s tenosynovitis, trigger finger, and carpal tunnel syndrome. These diagnostic criteria include mechanism of injury, patient symptoms, physical examination maneuvers, and for some disorders,

diagnostic test results. The described mechanisms of injury for over two dozen listed

disorders include repetitive use, chronic overuse, or repeated trauma.

Good quality epidemiologic studies have used definitions of MSDs which require

combinations of symptoms and physical examination findings which are similar or

identical to the information used to diagnose patients in clinical practice. Many of

the MSD definitions used in the epidemiologic studies are the same definitions of

MSDs described in medical textbooks and in practice guidelines. The work exposures described in the scientific literature are reflected in the work exposures reported by my patients with musculoskeletal disorders, and by the work exposures

which I have observed on visits to workplaces with high rates of musculoskeletal

disorders. These same work exposures are the ones cited by the American College

of Occupational and Environmental Medicine in their practice guidelines and by the

ACGIH in their threshold limit values for physical exposures.

THE IMPORTANCE OF EARLY RECOGNITION AND APPROPRIATE TREATMENT OF MSDS

The proposed OSHA ergonomics standard required early access to appropriate

medical treatment, evaluation of workers’ jobs when there has been a MSD, and the

provision of limited or modified work duties when necessary, including when recommended by a health care provider. Each of these individual provisions is supported by current research and clinical practice. In addition, there is good evidence

that comprehensive programs which integrate ergonomic changes and medical treatment are effective in reducing the incidence and severity of work-related musculoskeletal disorders.

Early recognition and treatment of musculoskeletal disorders is essential because

it allows earlier treatment of affected workers, at a time when treatment can prevent progression to a more severe condition. Workers who are treated in the early

stages of a disorder have a better prognosis, and are less likely to have prolonged

disability, than workers who receive appropriate medical attention only after prolonged duration of symptoms. The medical literature consistently supports the observation that conservative management is most effective when begun in the early

stages of these disorders, and that patients who are treated only after a prolonged

symptomatic period are less likely to respond favorably than those treated earlier

(Gelberman et al., 1980; Dellon, 1989; Stern, 1990; Rystrom & Eversman, 1991).

With some disorders, such as carpal tunnel syndrome, patients can often be treated

conservatively in the early stages of disease, while surgery is often necessary when

patients present with advanced disease. Early detection is necessary to ensure that

signs and symptoms of work-related MSDs are recognized and treated appropriately

through medical management, administrative controls, and job evaluation.

Both healthy and injured workers can potentially benefit from evaluation of their

workplace for identification of physical stressors that can be eliminated. Simple

modifications can often be made to a workplace which enable the work to be done

with less effort on the part of the worker. Such modifications, where possible, can

prevent injury and can enable injured workers to safely return to their usual jobs

more quickly. Clinical experience demonstrates that ergonomic evaluation and intervention is effective in the treatment of workers being treated for a work-related
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MSD, since earlier safe return to work is facilitated when clinicians have more information about a patient’s job demands and exposures, and when worksite modifications reduce physical exposures. A number of authors have advocated the importance of ergonomic changes in treating workers with work-related musculoskeletal

disorders (Melhorn 1996, Higgs and Mackinnon 1995, Norris 1993, Feuerstein et. al.

1993, Halpern 1992, Travers 1992, Herbert 2000).

Comprehensive ergonomic programs which incorporate primary prevention of

MSDs through ergonomic changes in jobs, early detection of MSDs through surveillance, and early treatment of MSDs with an emphasis on early return to modified

work have been endorsed by many corporations and by medical professionals. The

American College of Occupational and Environmental Medicine, the world’s largest

group of Occupational Health physicians, has recently released ‘‘Occupational Medicine Practice Guidelines’’ which describe what the College recommends as best medical practice in the diagnosis and treatment of work-related disorders. These practice guidelines explicitly recommend many of the elements which are contained in

OSHA’s proposed regulation as representing best medical practice. These include endorsement of the application of ergonomic principles to job design in order to prevent MSDs, and the use of workstation or tool adjustment to avoid further aggravation of a disorder once it has begun. Return of workers to modified work which has

reduced physical exposures is strongly recommended as part of treatment—the

guidelines note that the best success with return to work is seen when workers go

back to their original job with modifications to reduce physical exposures. The

guidelines list ‘‘substantive associations’’ between physical risk factors and a variety

of MSDs including shoulder tendonitis, hand/wrist tendonitis, carpal tunnel syndrome, neck muscle tension, and low back pain. Specific job modifications are recommended for these and other disorders. The guidelines also note that delayed presentation (not receiving early recognition and treatment) is a risk factor for delayed

functional recovery in patients with a MSD.

My own experiences from over ten years of treating injured workers have shown

me the importance of early treatment and the importance of modifying job duties

to facilitate return to work. The proposed ergonomics standard addressed these important aspects of disability prevention. While the main focus of prevention efforts

should be on primary prevention—the reduction or elimination of workplace risk

factors—it is also important to ensure that workers have access to appropriate and

timely medical care if they do become injured. The goals of a medical management

program should be to reduce or eliminate symptoms, prevent progression of MSDs,

reduce the duration and severity of functional impairment, and prevent or reduce

the severity of disability. Important elements to such a program include surveillance, timely access to appropriate health care providers, job evaluation of injured

workers, and the availability of appropriate job modification. Follow-up of treated

workers and coordination with primary prevention efforts are also important.

My clinical experience clearly indicates that effective treatment of work-related

musculoskeletal disorders frequently requires a reduction in workplace physical exposures for the affected employee. The vast majority of injured employees are able

to return to productive work very quickly, as long as their work is modified to reduce physical exposures to the affected body part. Job modifications which reduce

physical exposures are frequently inexpensive and simple, and can help an employee

safely return to work sooner, as well as preventing risk of future injury. Examples

of job modifications include training or retraining, simple job changes to prevent

awkward postures (such as a step stool or tilted work surface), changes in tool design or maintenance, or changes in procedures (such as job rotation). Where there

is no simple fix for a physical exposure which is causing or exacerbating a musculoskeletal condition, temporary job transfer or restrictions are important to allow the

patient’s injury to heal. Examples of temporary restrictions include reduction in

pace or quantity of work, restriction of certain tasks, or limitation of hours worked.

If an employee is to be transferred to a different job, the new job should be assessed

by the employer and the healthcare provider to be sure that the employee will not

be exposed to relevant physical risk factors When this cannot be accomplished, temporary removal from work will allow time for healing. In most cases, I feel that

keeping an injured employee at work in an appropriate modified position is preferable to time loss. What OSHA is requiring in the standard is common medical

practice among occupational health professionals.

In my experiences of treating patients and advising the administration of employee health programs, I have found that choice of a healthcare provider for injured

workers is important. Ideally, healthcare providers should have training or experience in ergonomics and the role of work modifications in the treatment of work-related musculoskeletal disorders. Effective diagnosis and treatment requires knowledge of specific job duties. The best way for a healthcare provider to get knowledge
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of job duties is through a worksite visit. Since this is impractical in some clinical

settings, information about exposures and job duties can also be obtained through

a written work description, or a videotape of the job task. Employers should have

a contact person with knowledge of job activities and the ability to coordinate appropriate job placement during a recovery period. Working knowledge of the industry

and the specific workplace is also needed in order to make appropriate recommendations regarding temporary or permanent job modifications. In my experience, some

employers readily provide detailed information about job duties and physical exposures to the treating physician. It is more difficult to provide optimal care for injured workers when this information is not available.

The medical literature has examples of successful programs which have decreased

the length or severity of disability resulting from injuries through integrating ergonomic interventions as part of medical treatment of injured workers. One such study

evaluated work-related back pain among workers from a variety of industries who

had been away from work for more than four weeks due to their back injuries.

(Loisel et. al. 1997). Workers were randomly assigned to receive an ergonomics

intervention, an intensive clinical and rehabilitation intervention, neither, or both.

The ergonomics intervention consisted of a worksite ergonomics evaluation that included labor and employer representatives in determining the need for job modification. After observation of a worker’s tasks in conjunction with a trained ergonomist,

these parties determined the need for modifications to improve the worksite. Implementation of the recommended solutions remained the employer’s responsibility.

The clinical and rehabilitation intervention consisted of patient education (‘‘back

school’’), referral to a back pain specialist, and a multidisciplinary work rehabilitation intervention. Combination of the rehabilitation intervention along with the

ergonomics intervention was the most successful in returning injured workers to

work. The ergonomics intervention was the most successful element of this program,

resulting in more than a two-fold increase in the rate of return to usual work. By

facilitating return to usual work, the ergonomics intervention appeared to reduce

progression to long term disability. In this study, the intensive clinical and rehabilitation intervention did not significantly reduce the time of absence from regular

work when applied separately from the ergonomics intervention.

Another example of an integrated program was reported among sheet metal workers at an aircraft manufacturer. This program combined pre-placement evaluations

of workers with ongoing surveillance for symptoms and signs of upper extremity

musculoskeletal disorders in order to ensure early medical evaluation of affected

workers. Job modification was implemented for those with signs of early disorders,

through restriction of work hours and restriction of use of vibrating hand tools. This

program reported decreased workers’ compensation costs, decreased time loss, and

decreased severity of injury following the implementation of this program for screening, surveillance, early medical evaluation, and job modification. (Melhorn JM 1999)

Other authors have described comprehensive initiatives to manage the incidence

and cost of occupational injuries that included an ergonomics component directed

specifically toward injured workers. One such program has been described among

hospital employees at an academic health center (McGrail et. al. 1995). This study

showed decreases in musculoskeletal injuries, time loss (change from 10.4 days to

6.6 days average time loss), and total case costs (18 percent reduction) following the

implementation of a comprehensive intervention that included case management,

treatment by physicians experienced with work injuries, and the use of ergonomic

worksite evaluation and modification. A later report from this group described elements of the program aimed at the early diagnosis and treatment of work-related

upper extremity MSDs. The program included ergonomic assessment and abatement

of the affected employees’ work areas, and close coordination between the treating

physicians and the ergonomists. The program resulted in pronounced decrease in

the number of work-related upper extremity MSDs and a virtual elimination of

cases which required surgery. The authors concluded that a coordinated program of

medical care, ergonomic assessment, and intervention can be effective in the prevention of MSDs. (Bernacki 1999)

These and other peer-reviewed studies clearly indicate that a multi-element program can reduce the cost and burden of MSDs in different working populations.

There are also numerous industry case reports where the introduction of ergonomic

or medical management interventions have reduced costs and injury rates. Most

major corporations have ergonomics programs, in recognition that such programs

are effective in reducing injuries. Successful approaches have most often used a

combination of ergonomic principles for prevention, as well as improved recognition

and management of those disorders which have occurred.

I have also studied the effects of ergonomic assessments and interventions as part

of the care of workers with WRMSD. As the result of a ‘‘natural experiment,’’ we
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have collected pilot data on cost outcomes of ergonomic intervention in active workers’ compensation patients employed by a local educational institution. Prior to September of 1996, ergonomic evaluations requested by the treating physician were not

covered by the workers’ compensation insurance carrier and requests for this service

were denied. This policy changed, and ergonomics evaluation and intervention was

then allowed under workers’ compensation when ordered by the treating physician.

These cases were predominantly neck and upper extremity disorders among office

employees; the ergonomic interventions consisted of changes in workstation layout.

We compared 11 consecutive cases referred by the treating physician to the

ergonomist prior to the administrative change with 20 consecutive cases after coverage was allowed. These cases were all ones in which the treating physician

thought that work factors were important in causing disease or retarding healing.

Comparison of total workers’ compensation costs for these cases showed a median

cost of $5,130 among the patients referred for ergonomic evaluation who did not receive it, compared to a median of $4,082 among patients who did receive the physician recommended ergonomic evaluation. Costs included medical treatment, time

loss, and permanent disability payments. Cost in the intervention group included

the cost of the ergonomic evaluation and intervention, which averaged $280. Although these data do not come from a randomized study, they represent a series

of cases from the same workplace referred by the same group of treating physicians,

differing only in the fact that the ergonomic intervention was denied to the first

group and given to the second. Based in part on this study, we are currently conducting a randomized trial funded by NIOSH to assess the effectiveness of an integrated ergonomics and case management intervention on cost and disability outcomes among injured workers.

THE EFFECTIVENESS OF ERGONOMIC INTERVENTIONS

Review of the scientific literature demonstrates that workplace ergonomic interventions can prevent injuries and reduce days lost due to injuries. This evidence

comes from a number of studies published in the peer-reviewed literature which

show the effectiveness of ergonomic interventions at various worksites and employers. The 1998 report by the National Research Council stated that ‘‘The literature

provides evidence that interventions, of various types and complexity, can prevent

the development of musculoskeletal disorders in specific industries and occupational

groups.’’ The NRC report concluded that ‘‘Research clearly demonstrates that specific interventions can reduce the reported rate of musculoskeletal disorders for

workers who perform high-risk tasks. No known single intervention is universally

effective. Successful interventions require attention to individual, organizational,

and job characteristics, tailoring the corrective actions to those characteristics.’’ Examples of published intervention studies familiar to me are given below; the background information provided by OSHA gives over 100 examples of successful ergonomic interventions.

The effectiveness of ergonomic interventions in the prevention of musculoskeletal

disorders was shown by a study in a telecommunications equipment manufacturing

plant, where workstations were re-designed to reduce postural stress on workers.

Following this intervention, time loss was reduced by over 40 percent and employee

turn-over was reduced by 75 percent. Cost-benefit analysis showed that the return

on investment for the ergonomic interventions was 9 to 1. (Aaras 1994). Another

study in telecommunications manufacturing sought to control the incidence and severity of repetitive trauma disorders associated with hand tool operations in a manufacturing facility with 6,600 employees. Repetitive trauma disorders were the leading cause of lost time and workers’ compensation expenses at this plant. The incidence rate of OSHA reportable repetitive trauma disorders was 2.2 cases per 100

full-time equivalent workers (FTE) and resulted in 1,001 lost workdays in 1979. In

the spring of 1981, the plant safety and health committee undertook a control program that included creation of a task force, a training program, improvements in

the design of workstations and tooling, and management of restricted workers. During 1982, the incidence rate of repetitive motion disorders has decreased to 0.53

cases per 100 FTE and resulted in only 129 lost workdays. (McKenzie 1985)

A study at Gold Kist poultry (Jones 1997) reported results of an intervention undertaken due to high rates of upper extremity MSDs—47.7 per 1,000 workers in

1990. This plant instituted a corporate ergonomics program which utilized ergonomic committees at each facility. Key program elements included training, worksite analysis and task design, and the implementation of medical management procedures. This combination of worksite task analysis and medical management is

similar to the program elements proposed by OSHA. This program resulted in a 46

percent decrease in upper extremity MSD rates over a five year period.
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Another study evaluated a back injury prevention program undertaken in municipal workers in California. The program consisted of a combination of worker education, training in safer work practices, physical fitness activities, and ergonomic

interventions including making safety equipment more available and improving the

design of work facilities (through such measures as safety flooring, improved furniture, and rearranging storage space to minimize transport distances). Comparison

of an intervention group and a control group of employees who did not receive the

intervention showed a decline in back pain prevalence and a reduction in injuries

among the intervention group. This study evaluated cost savings due to the intervention as well as documenting the reduction in back pain and injuries. Cost-benefit

analysis showed a net savings of over $160,000 resulting from decreased workers’

compensation and medical claims, and reduction in sick days. Return on investment

was estimated at 179 percent. (Shi 1993)

One of my own studies (Evanoff 1999) examined work injuries and other outcomes

before and after the implementation of a participatory ergonomics team among hospital orderlies, a group at high risk for injuries of the back, shoulder, and knee. This

team designed and implemented changes in training and work practices, which included standardization of lifting procedures, an apprenticeship program for new

workers, and use of mechanical lifting and transfer aids. The two year post-intervention period was marked by a 50 percent decrease in OSHA recordable work injury, a 74 percent decrease in lost time injury, and an 81 percent decrease in injuries with three or more days of time loss. Total lost days declined from 136.2 to 23.0

annually per 100 full-time worker equivalents (FTE). Annual workers’ compensation

costs declined from $237/FTE to $139/FTE. The proportion of workers with musculoskeletal symptoms declined as well. Other researchers using participatory

ergonomics teams have demonstrated the abilities of such teams to work effectively

to address musculoskeletal hazards (Moore and Garg 1996, Moore and Garg 1997).

I have directed a second study which has been presented as an abstract but not

yet published. This was an ergonomics intervention among 117 workers employed

in a hospital billing office, who were offered an educational session and individual

workstation evaluations, with changes in workstation layout where appropriate.

Changes included adjustments in computer keyboard and monitor setup, adjustments in seating, and changes in desk layout. Lost work days and total costs for

workers compensation decreased dramatically in the two years following this intervention, compared to the two preceding years. Annual lost work days declined from

a rate of 51 days per 100 full-time equivalents (FTE) to a rate of 25 days per 100

FTE. Annual workers’ compensation costs declined from a high of $578 per FTE to

a low of $120 per FTE. The total cost of the intervention was $255 per FTE; return

on investment over 18 months following the intervention was over 2 to 1.

Other studies (Kukkonen 1983, Ohara 1976, Parenmark 1988, Oxenburgh 1985,

Lutz 1987) have also demonstrated reductions in symptoms, signs, or lost time following the implementation of interventions to reduce exposure risk factors for musculoskeletal disorders. Ergonomic job design clearly offers great potential for preventing musculoskeletal disorders of the low back and upper extremities. (Garg &

Moore 1992).

My personal experience agrees with the literature cited above. I am personally

aware of many local worksites where ergonomic analysis and job changes have led

to improvements in symptoms or reductions in injury rates among workers. I have

seen dozens of case reports of industries where the implementation of ergonomics

programs have resulted in reductions in injury rates or lost time. These industry

case reports offer important additional information to the peer-reviewed scientific

literature, given the daunting logistical and other barriers to performing true ‘‘experimental’’ studies of workplace ergonomic interventions. I have served as the medical director of an ergonomics program aimed at reducing injuries among the 23,000

employees of a large health system. Musculoskeletal injuries and lost days have declined since the implementation three years ago of a system-wide ergonomics program. A NIOSH funded project within five nursing homes in our health system has

demonstrated a marked decline in lifting injuries following an ergonomics intervention which consisted of training and the purchase of mechanical patient hoists.

My personal experiences with research studies of ergonomic interventions, as well

as my experience with ergonomic programs in industry, have convinced me that appropriately designed ergonomics programs can reduce injuries and disability in

many workplace settings.

SUMMARY

Based on my knowledge of the relevant scientific literature, my observations of

best practices among employers and physician groups, and my own clinical and ad-
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ministrative experiences, I conclude that there is ample evidence to support specific

program elements proposed by OSHA. Physical exposures in the workplace are

clearly a significant cause of musculoskeletal disorders. Reduction in physical exposures through training, workplace design, or change in practices can reduce disability due to musculoskeletal disorders. Appropriate medical treatment early in the

course of work-related musculoskeletal disorders can lead to better functional outcomes and reduced disability. Though future research findings will no doubt refine

and better inform our actions, we need not wait to begin action. Effective solutions

are available now, and a large burden of disability can be prevented by using what

we currently know.

APPENDIX—REFUTATION OF SOME COMMON ARGUMENTS AGAINST AN ERGONOMICS

STANDARD

Critics of the conclusion that work activities are causally related to musculoskeletal disorders raise a number of arguments which are not convincing on closer

examination. Four common arguments are addressed below.

Argument 1: Epidemiology or observational studies cannot demonstrate causation;

only randomized prospective studies can do this.—While experimental studies where

humans are randomly assigned to receive or not receive some treatment provide the

strongest evidence for a health effect, it is obviously impossible to perform this type

of study for exposures we think may cause harm. There are well-established ways

to link observational data to a decision about causation of illness which can be valid

in the absence of experiemental data. For example, the vast majority of the scientific

community concluded that tobacco smoking caused a number of health problems

based on observational studies which showed much higher rates of some diseases

among smokers. It was not necessary to do an experiment where people were randomly assigned to smoke or not smoke. Data on the health effects of most occupational exposures such as lead or asbestos also rely on observational studies, which

can demonstrate causality in a scientifically acceptable fashion.

Argument 2: Work can’t be the cause of MSDs since some workers get these disorders and other workers doing the same job don’t have any problems.—This argument is specious. People vary in their susceptibility and resistance to disease and

injury, and people with identical exposures frequently have different health effects.

Exposures clearly interact with personal factors to produce disease in some but not

others—this does not change the importance of the exposure in causing the disease.

A minority of heavy smokers die from lung cancer, yet we readily accept that smoking causes lung cancer because heavy smokers are much more likely to get this disease than non-smokers. Though genetic makeup and other personal factors are

clearly important in determining which smokers die from lung cancer, in the absence of smoking the vast majority of these cancers would never have occurred.

Argument 3: Work can’t be a major cause of MSD since there are so many other

conditions which contribute to MSD risk.—As with most diseases, MSDs are multifactorial in origin. It is nonetheless possible to study the effects of risk factors in

isolation. Consider, for example, heart disease. There are many risk factors for heart

disease which cannot be changed, including age, gender, and genetic makeup. There

are other risk factors that can be changed, such as high blood pressure, blood lipids,

exercise, and smoking. Most individuals have more than one risk factor, yet we can

study the amount of heart disease that is caused by smoking, or hypertension, or

lack of exercise. We can also direct interventions at reducing heart disease risk by

targeting one or more of these risk factors. Changes (positive or negative) in one

risk factor can significantly alter the risk of disease, even if other risks do not

change. Similarly, in MSDs, personal risk factors such as obesity, age, gender, and

other medical conditions account for some fraction of the total disease burden. In

many workers, however, workplace exposures are the primary determinant or cause

of the disorder. Comparisons of working populations which do not differ substantially in non-work risk factors have shown substantial differences in MSD rates

linked to workplace exposures. The intervention studies cited above show that prevention efforts targeted at workplace physical exposures can reduce the risk of

MSDs.

Argument 4: Research shows only that work may cause some symptoms of discomfort, but does not show that work causes diagnosable diseases.—High quality studies

of work-related MSDs have defined these disorders through the same methods used

by clinicians to diagnose MSDs—a combination of history, physical examination

findings, and, in some cases, nerve conduction studies. The NIOSH review (Bernard

1997) only considered studies where clinical case definitions included the use of

physical examinations as well as symptoms. The case definitions used in much of
107

the research on musculoskeletal disorders are similar to the diagnostic methods

used every day by clinicians.

Senator SPECTER. Thank you very much, Dr. Evanoff. Turn now

to Ms. Heidi Eberhardt, international trade specialist.

STATEMENT OF HEIDI EBERHARDT, INTERNATIONAL TRADE SPECIALIST

Ms. EBERHARDT. Good morning. My name is Heidi Eberhardt. I

am from Boston, Massachusetts, and I want to thank you for inviting me to testify today.

Two and a half years ago, when I was 30 years old, I was injured

at my job from working on the computer. I was working 40 hours

a week at a dot com internet publishing company. I was an international trade specialist and my job consisted of using the computer keyboard most 8 hours a day for writing, editing and researching about Latin American countries, surfing the web and emailing with foreign officials.

As an undergraduate at Dartmouth College, I majored in Spanish and studied in Latin America. When I started this job 6 years

ago, I was thrilled to have found work where I could put my education to use. I was excited to be working in a cutting-edge industry with the advanced computer technology that allowed me to be

more productive and perform my job more efficiently.

I had never heard about repetitive strain injuries. I did not know

I could be injured from working on the computer. I did not know

what workers’ compensation was.

I was a healthy and happy individual in all respects and exercised regularly. I had no hobbies that were repetitive in nature.

My company provided no education or training about ergonomics

or working safely on a computer. Our computer work stations were

not set up properly.

There was another young employee in our department who after

only working 3 months with us had already begun to experience

symptoms of repetitive strain injury from working at the computer.

I was diagnosed with bilateral tendonitis, tenosynivitis, thoracic

outlet syndrome and De Quervain’s thumb.

At first, my symptoms were merely annoying. My wrists would

ache and my hands felt clumsy. Then I started to notice tingling

and pain that persisted even at rest, even on the weekends.

My pain and loss of dexterity became so severe that I could no

longer type or do anything on the computer, let alone perform any

hand-related tasks outside of work.

My doctor sent me out of work for 4 months, and I had to file

for workers’ compensation. I was returned to light duty for 12

hours a week, but my symptoms had not completely gone away and

I was still working in pain.

I since have switched to a job where I do not use a computer,

but even writing, looking through files or even holding the phone

still hurts my hands. So now at age 32, 21⁄2 years after being injured, I am still on workers’ compensation and still working only

12 hours per week. I am greatly hindered in my ability to contribute in a productive way to the workforce and am not paying

taxes.
108

After college, I had spent several years mastering research and

writing skills. I was building a career, one that was satisfying, productive and seemed to be full of potential.

I am now sitting before you, a young person faced with having

to find a new career that does not require a computer or even much

use of my hands. I am faced with reduced income and increased

medical expenses. I am faced with chronic pain which affects my

work productivity.

I have a restricted personal life and am unable to perform daily

chores outside of work without pain. I have had to endure the stigma of being injured and on workers’ compensation.

Doctors can tell me what my injury is. My tendons and ligaments

are damaged because of repetitive hand use of the computer. No

doctor can tell me if I will fully recover.

I am worried about my future and about whether I will ever regain complete use of my hands. I am a single person and do not

have anyone to assist me with daily living, nor do I have the financial resources to pay someone to help me.

I would like to get married and have children some day and am

worried about not being able to physically raise children.

Here are a few simple things I used to take for granted but I now

have difficulty with: Squeezing shampoo bottles, toothpaste tubes,

turning on and off faucets, clipping finger and toe nails, driving,

shifting gears, holding the steering wheel, carrying groceries, cooking, carrying heavy pots, opening cans, cutting things, putting

away dishes, cutting my food, opening milk cartons, making coffee,

holding coffee, getting ice cubes out of the ice tray, dressing myself,

buttoning my pants and my shirts, pulling things on, hanging up

clothes, doing laundry, carrying clothes to the laundromat, pulling

clothes in and out of the washer and dryer, folding clothes, cleaning

house, writing letters, writing checks for bills, opening mail, opening doors and windows, turning my house key in the lock or my

car key in the ignition; in short, almost anything you need your

hands to do. And this list does not include anything I might want

to do for fun.

In March of last year, I testified at the public hearings that

OSHA held on its then proposed ergonomics standard. When the

ergonomics standard was issued last November, I was proud of our

government for recognizing and acting to prevent what I now know

is the Number 1 injury in the workplace, an injury that I know

about firsthand and have been trying to recover from for 21⁄2 years,

an injury that has profoundly altered my life and left me unable

to work on the computer.

So when both houses of Congress voted to repeal the very standard that would have prevented millions of devastating injuries, I

was deeply dismayed.

What was most disturbing was the manner in which it was done.

The votes were rushed through without any input from the workers

it would have protected. This action seemed only to put the interests of corporations above the safety and health of workers in this

country. Millions of workers have suffered ergonomic injuries over

the past decade while waiting for protections.

Senator SPECTER. Ms. Eberhardt, I have to remind you that the

time is up. If you could summarize, we would appreciate it.
109

PREPARED STATEMENT

Ms. EBERHARDT. I know that companies who have put into place

ergonomic programs have been successful. They have reduced costs.

And I know that these ergonomics programs which include simple

education and training can prevent the kind of injury that I have

sustained and I strongly urge you to continue your hard work.

[The statement follows:]

PREPARED STATEMENT OF HEIDI EBERHARDT

My name is Heidi Eberhardt. I am an international trade specialist from Somerville, Massachusetts. I am here today to tell you about an injury that has changed

my life.

In the Fall of 1998, when I was 30 years old, I was injured at my job from working on the computer. I was working 40 hours a week at a .com Internet publishing

company. There were 8 employees in the company, and I was working in the department responsible for researching and writing about international trade issues.

My job as an international trade specialist consisted of writing, researching, and

editing which was performed 8 hours a days, 5 days a week on the computer using

a keyboard and a mouse. This included typing, cutting and pasting, formatting,

scrolling through 20 page documents, surfing the web and corresponding via email

with customers and information providers. We had a heavy workload with weekly,

sometimes daily, deadlines. We were always behind. There was so much to do, I

stopped only for breaks to go to the restroom and to get my lunch to eat at my desk

while I was working.

As an undergraduate at Dartmouth College, I majored in Spanish and studied in

Latin America. When I started this job six years ago, I was thrilled to have found

work writing about Latin American countries where I could put my education to

use. I had never heard about repetitive strain injuries. I did not know I could be

injured from working on the computer. I did not know what worker’s compensation

was. I was a healthy and happy individual in all respects and exercised regularly.

I had no hobbies that were repetitive in nature.

In January of the same year I was injured, my company had switched from Windows 3.1, with no internet or e-mail access, to Windows 1995 and a direct connection to the Internet, internal and external email, and websurfing capabilities. I was

happy that we could work faster and perform more job tasks on the computer at

once. With these new computer programs there is no need to pause between tasks.

My company provided no education or training about ergonomics or working safely on a computer. I’ve since learned that our computer workstations were not set

up properly. There was another young employee in our department who, after working only three months with us, had already begun to experience symptoms of repetitive strain injury from working at the computer. Since being injured, I have received extensive ergonomics education from occupational therapists. This education

came too late to prevent my injury, and it is information that most workers will

never hear without the types of workplace programs that OSHA tried to put in

place.

At first my symptoms were merely annoying. My wrists would ache and my hands

felt clumsy. Then I started to notice tingling, and pain that persisted even at rest,

even on the weekends. My pain and loss of dexterity became so severe that I could

no longer type or do anything on the computer, let alone perform any hand-related

tasks outside of work.

At my doctor’s and occupational therapists’ insistence, I filed for Worker’s Compensation. My doctor, who had diagnosed me with bilateral tendonitis, tenosynivitis

and DeQuervain’s syndrome, prescribed rest and abstaining from work. After being

out of work for 4 months, I returned to light duty for 12-hours a week. But, my

symptoms had not completely gone away, and I was still working in pain. I since

have switched to a job where I do not use the computer, but even writing, looking

through files, or even holding the phone, still hurts my hands. Now, at age 32, two

and a half years after being injured, I am still on worker’s compensation, and still

working only 12 hours per week. I am greatly hindered in my ability to contribute

in a productive way to the workforce, and I am not paying taxes.

After college, I spent several years mastering research and writing skills. I was

building a career, one that was satisfying and productive and seemed to be full of

potential. I am now sitting before you, a young person faced with having to find a

new career that does not require a computer or even much use of my hands—please

imagine that if you can. I am faced with reduced income and increased medical ex-
110

penses. I am faced with chronic pain which affects my work productivity. I have a

restricted personal life and am unable to perform daily chores outside of work without pain. I have had to endure the stigma of being injured and on worker’s compensation. And I have suffered depression as a result of dealing with the pain and

uncertainties about my future.

Doctors can tell me what my injury is—my tendons and ligaments are damaged

because of repetitive hand use at the computer. No doctor, however, can tell me

when I will be fully recovered. I am worried about my future and about whether

I will ever regain complete use of my hands. I am a single person and do not have

anyone to assist me with daily living, nor do I have the financial resources to pay

someone to help me. I would like to get married and have children someday and

am worried about not being able to physically raise children.

Here are a few simple things that I used to take for granted, but I now have difficulty with:

—squeezing shampoo bottles, dishwashing detergent and toothpaste tubes

—turning on and off faucets

—clipping finger and toe nails

—driving, shifting gears, holding the steering wheel

—carrying groceries

—cooking, carrying heavy pots, opening cans, cutting things, putting away dishes

—cutting my food

—opening milk cartons, bottles, cans

—making coffee, holding coffee

—getting ice cubes out of the ice tray

—moving anything heavy

—dressing myself (buttoning pants and shirts and pulling things on)

—hanging up clothes

—doing laundry (carrying clothes to laundromat, pulling clothes in and out of

washer/dryer, folding clothes)

—cleaning house (washing counters, bathrooms, vacuuming)

—writing letters, grocery lists, etc.

—writing checks for bills

—opening mail

—opening doors and windows

—turning my house key in the lock, or my car key in the ignition

—picking up my 2-yr old nephew

In short, almost anything you need your hands to do, and this list does not include anything I might want to do for fun, nor does it include computer or work

activities.

In March of last year I testified at the public hearings that OSHA held on its then

proposed ergonomics standard. When the ergonomics standard was issued last November, I was proud of our government for recognizing and acting to prevent what

I know is the number one injury in the workplace today. An injury that I know

about first hand and have been trying to recover from for two and a half years. An

injury that has profoundly altered my life and left me unable to work on the computer. So when both houses of Congress voted to repeal the very standard that

would have prevented hundreds of thousands of serious injuries, I was appalled.

What was most outrageous was the manner in which it was done. The votes were

rushed through without any input from the workers it would have protected. The

action taken by Congress and the President seemed only to put the interests of corporations above the safety and health of workers in this country.

Millions of workers have suffered ergonomic injuries over the past decade while

waiting for protections. How many more workers need to suffer these crippling injuries before this problem is addressed?

When I was first injured, I went to the Massachusetts Coalition on New Office

Technology (CNOT) because they offer resources to injured workers. Now I work for

CNOT part time, providing training on ergonomics and injury prevention. Part of

my work involves evaluating employees’ workstations. What I see in my work validates the overwhelming need for a Federal ergonomics standard. More often than

not, workers are sitting in improperly set up workstations, with little knowledge of

the impact that this can have on their health, and as I know first hand, their entire

lives. What is even more frightening is that close to 25 percent of the people I see

already have symptoms of injury.

These injuries can be prevented with programs that include appropriate

workstations and training for workers. Once an injury sets in it is difficult, if not

impossible, to reverse the damage. I implore you to pass legislation that requires

OSHA to issue a strong ergonomics standard that covers workers in all industries

and emphasizes prevention of repetitive strain injuries. I am only 32, but I know
111

people who are in their early twenties, working in Internet companies or as software

engineers, who are injured.

Workers in this country desperately need an ergonomics standard to prevent even

more debilitating injuries from occurring. Too many companies will not act to protect their employees unless required to by law. I sincerely hope that my testimony

today gives you a better idea of what can happen to workers, including very young

workers, in today’s computer-driven workplaces and how these injuries are affecting

our lives. Your work to pass this bill can prevent this story from being told over

and over again, by injured worker after injured worker. Thank you for this opportunity to tell you my story.

Senator SPECTER. Thank you very much, Miss Eberhardt.

Mr. Fellner, do you think that it is realistic to expect a consensus

on the issues that are involved in ergonomics based on the testimony we have heard here in this first panel?

Mr. FELLNER. I think that we will not know the answer to that

question until a much more exhaustive analysis of the issues that

are touched on this morning has been had at the Department of

Labor.

Senator SPECTER. Dr. Bigos, you say there is no scientific basis.

You cannot diagnose and you cannot prevent. In the absence of a

scientific basis, your testimony is pretty plain that from your professional expertise and in the absence of a scientific basis and the

cost of a regulation simply cannot have one. Isn’t that right?

Dr. BIGOS. Well, I guess I am not sure I understand the question

you are asking me.

Senator SPECTER. Well, let me repeat the question. You testified

that there was no scientific basis for an ergonomics regulation, did

you not?

Dr. BIGOS. Yes, I did.

Senator SPECTER. So how can you have an ergonomics regulation

without a scientific basis as you view this entire issue?

Dr. BIGOS. I do not think you can.

Senator SPECTER. That is my point. You do not think we can.

Dr. BIGOS. No. Without knowing the dose and without knowing

how high or how much or some guidance in some way, I do not see

any way that we can really do that.

Senator SPECTER. Well, I understand your point. I was just making sure that I understand it. You cannot have an ergonomics regulation. Ms. Seminario?

Ms. SEMINARIO. Seminario.

Senator SPECTER. In the absence of a scientific basis, which Dr.

Bigos testifies to, what basis do you have for postulating a regulation besides, if anything, all of these reports of work-related injuries?

Ms. SEMINARIO. A couple of things, Senator. First, we do think

there is a scientific basis that is fairly extensive and quite strong

and certainly sufficient to regulate. There is also the experience

that employers and unions and others have had dealing with these

problems in the workplace which again is quite extensive.

And we had encouraged the Labor Department and we would

still encourage the Labor Department to look to that experience of

employers in addressing these problems as the approach that they

should take to regulation.

I would also point out that this issue has been regulated. There

are regulations on manual handling, ergonomics, video display terminal use that have been in place in the European community for
112

more than a decade. Many of the same employers that obviously

operate——

Senator SPECTER. Are they in place in Workman’s Compensation

laws in the State level?

Ms. SEMINARIO. Not the preventative aspects. Obviously these injuries are——

Senator SPECTER. The diagnosed aspects?

Ms. SEMINARIO. Yes. The diagnosed aspects certainly are and the

criteria in some of the states are quite similar to the criteria and

definitions laid out by OSHA.

Senator SPECTER. When I listened to the testimony of Dr.

Evanoff and Dr. Hadler, diametrically opposed, we have quite a

number of witnesses to hear, and I will reserve judgment; but from

what I have heard on this panel, Mr. Fellner, I do not see a consensus emerging at all.

When you talk about, as Dr. Bigos does about nonphysical factors

outweighing physical factors on back pain, we have all had some

experience with lifting and pack pain.

My dad had a junk yard in Russell, Kansas. And it did not take

me a whole lot of time to figure out that lifting a 30-foot joint of

3-inch tubing that weighed 300 pounds, and I was lifting half of it,

and maybe we do not need an ergonomics regulation when my

older brother one day told me to throw a rock bed on top of a load

of junk which weighed about 80 pounds, and I simply refused, having in mind the sciatica nerve which he had injured and could not

lift junk anymore.

He was smart enough to sustain an injury so he could avoid the

lifting. But we will wrestle through the problems. I would like to

call the second panel now. Dr. Burton, Dr. Punnett and Dr. Mirer.

I am sorry. Before the panel leaves, Miss Landrieu.

Senator LANDRIEU. The panel can go. The new panel can come.

But I will just make a brief statement, if I could.

Senator SPECTER. Okay. Fine. Pardon me Senator Landrieu, for

not noticing you.

You took a seat so far to the right.

There are at least two attributes about your appearance I should

have noted, and I will not specify them for the record.

Senator LANDRIEU. And I wore this bright red jacket so it is hard

to not notice me today. But I thank you, Mr. Chairman.

Senator SPECTER. It is hard not to notice you in the absence of

a red jacket.

Senator LANDRIEU. Thank you, Mr. Chairman. If the new panel

would just come forward, I do not want to stop you all from moving

forward. I do want to just make a couple of comments though.

Senator SPECTER. Senator Landrieu, while you are making the

comments, I am going to excuse myself for a moment. We have Secretary Manetta testifying in Transportation. I am going to be gone

for a very brief period of time. Senator Landrieu has the floor and

I shall return momentarily.

OPENING STATEMENT OF SENATOR MARY L. LANDRIEU

Senator LANDRIEU. Thank you, Mr. Chairman. I have a statement I would like to submit to the record. And I would like to ask
113

unanimous consent. Since I am the only one here, I am going to

give myself unanimous consent to submit this to the record.

But I would just want to make a few points, and then unfortunately I am going to have to slip out for another meeting myself,

and some responsibilities on the floor.

I want to thank the chairman first of all for calling this very important hearing because we need the chairman and our ranking

member to help us stay focused on this very important issue so it

does not slip off the radar screen.

I was briefed at some of the comments earlier made about how

important it is to develop a consensus. And we try very hard to do

that here in Washington on a number of different issues, whether

it has to do with health or transportation, environmental issues. It

is always desirable I think to build consensus, but it is not necessary. What is necessary is a majority, a majority to vote, to take

an action.

We do not need a unanimous vote. We do not need always a consensus. And many of the most important issues that have moved

through Congress in the history of this Nation have not necessarily

moved by consensus but they have in fact moved by a majority.

And I wanted to just show up this morning to say to the labor

and business leaders and to the workers here that I believe there

is a majority of Republicans and Democrats today that recognize

that this is a serious problem in the United States, that in fact

these injuries are real. They are affecting real people in real ways.

And we heard some of that testimony.

With all due respect to the scientists and to those academics that

would argue otherwise, I think we have passed that point; that this

is real and that there are a majority. We do not have everyone. We

do not need everyone. But there is a majority of votes in the Senate

and in the House to actually produce a rule that will work to prevent, to try to prevent these injuries.

What the challenge is, and I think what the question is which

is reflected in the vote that was cast just last week, is that the rule

that was presented before us either basically had to be completely

adopted or none of it could be adopted. The procedure did not allow

for us to sort of reshape that rule.

And so the vote occurred to reject it. But I hope there is no one

here in this room or around the country that would interpret that

vote as meaning that there are not a large number of Republicans

and Democrats, the majority here, to have a rule that will help prevent these injuries and to address it.

There is a majority that agrees that this cannot be voluntary,

that while voluntary actions can in fact help, that this needs to be,

it is proper rule for government. It needs to be mandatory. Workers

have a responsibility themselves in this regard as well as employers.

And so I want to commend the chairman for calling this hearing

to say that the challenge is now about how to present to the country a new rule, one that will address some of the concerns that

were raised. But we are not going to go backwards. We are going

to continue to move forward.

And I hope because of the bill that I have introduced with Senator Breaux and Senator Specter that that time frame could be
114

short, perhaps coming back with something in about 18 months for

the Congress to act on.

And let me say although I missed your testimony and I have the

greatest respect for our new Secretary and think that she most certainly can do a wonderful job, I was somewhat disappointed to hear

that she was not more enthusiastic about moving forward with a

new rule.

And I hope that this bill that we have introduced is going to encourage her in very direct ways to move forward with a new rule

within a short period of time, one that many employers could embrace and many workers. We do not need all employers but we

need many of them.

And many that came to my office against the old rule said, Senator, we are not opposed to the Government having mandatory

rules. We just want to make sure that we can understand it, we

can comply with it, that the workers have responsibilities as well

as we have responsibilities.

So I am going on their word, all the employers that came into

my office to testify to me in that regard. And I am going to do everything I can as a Senator to insist that we move forward way

past the discussions about whether this is true or not.

The American people understand these injuries are happening.

They are happening to them and their own families. We can hear

all the scientific testimony. We are past that point. We are now

about how to draft a good rule that works for big employers, for

small employers, that prevents these injuries and gives real relief

without perhaps overlapping too much with what some states are

doing to recognize the specific role of States.

So I am sorry I do not have a whole list of questions. I do, but

I do not have the time for them. But I wanted to get that statement into the record. And I thank you all.

If the staff will help me to continue to conduct this meeting while

the chairman is going, because I am going to have to slip out in

just a moment. But on behalf of Senator Murray who could not be

here, she did want me to recognize Dr. Bigos from Washington,

from the University of Washington, and to welcome you in her absence because you are a constituent of hers and she wanted me to

mention that this morning.

But whoever would like to proceed with their testimony, and

then I think if other members show up they will have questions or

comments. Who should we begin with?

It has been recommended that we just take a 5-minute recess

until the chairman comes back. Thank you.

Senator SPECTER. We’ll resume the hearing now with Dr. Kim

Burton, director of Spinal Research Unit, University of

Hudderfield, United Kingdom. Welcome.

STATEMENT OF DR. KIM BURTON, DIRECTOR, SPINAL RESEARCH

UNIT, UNIVERSITY OF HUDDERFIELD, UNITED KINGDOM

Dr. BURTON. Thank you, chairman. It is indeed a pleasure and

an honor to address this body on the controversial topic of

ergonomics. Recently in the United Kingdom, experts giving evidence in litigation cases need to sign declaration that their duty is
115

to the Court rather than to the party instructing them. It is in that

spirit that I address my views to you.

My background encompasses both clinical science and ergonomics. And as you said, currently I am the director of the Spinal

Research Unit at the University of Huddersfield. I am also a registered European Ergonomist, and have prepared reports and guidance for the Health and Safety Executive in the United Kingdom.

It is vitally important to distinguish between the various manifestations of musculoskeletal disorders. That is, they may present

as reports of symptoms, the filing of an injury claim, the need for

sick leave, the development of chronicity and irreparable damage.

Each of these components is unique. And it is somewhat

unhelpful to talk about them as if they are fully interchangeable.

Because low back pain is the area of my expertise and is such

a prominent target of OSHA’s recent regulation, I will use this as

an example. Low back pain is not a discrete disease entity or even

a single clinical syndrome. It is a symptom, a symptom experienced

by most people during their lifetimes, irrespective of employment.

General adult population surveys find a lifetime prevalence of

low back pain of around 60 percent, a 12-month prevalence of over

40 percent, and a point prevalence of approximately 20 percent.

The lifetime prevalence in adolescents, at just over 50 percent, is

only slightly lower than that for working-age adults. In the face of

such figures, attribution of the bulk of the symptoms to work, in

my view, is untenable.

Nonspecific low back pain can be occupational in a sense that it

is common in adults of working age, frequently affects capacity for

work, and often prompts referral for occupational health care. The

common assumption that this means that low back pain is necessarily caused by work, however, overlooks the complex and inconsistent relationship between physical and other influences.

The review that I coauthored with Professor Waddell last year

concluded that on the balance of the scientific evidence that it

showed physical demands of work can precipitate individual attacks of back pain. Certain individuals may be more susceptible

and certain jobs may be at higher risk. But viewed overall, physical

demands of work only account for a modest proportion of the total

impact of back pain.

The development of chronic pain and disability, however, depends more on individual or work-related psychosocial issues than

on physical or clinical features. People with physically or psychologically demanding jobs may have more difficulty working when

they have low back pain and so lose more time from work. But that

can be the effect rather than the cause of their back pain.

It is unrealistic to think that we can expect to prevent all low

back pain. What I understand to be OSHA’s apparent concept of

making all work physically undemanding is not only unsupported

but may well have adverse effects. There is strong chance of raising

the profile of the attribution concept among workers, their advisors

and managers, which in turn could lead to an exacerbation of the

overall impact of low back pain on society, rather than a reduction.

The state-of-the-art evidence assessing reductions in physical exposures as a prescription for ergonomic concerns is a comprehensive review from Linton and van Tulder. These authors systemati-
116

1Occupational Health Guidelines for the Management of Low Back Pain at Work, Evidence

Review and Recommendations (March 2000) (available at www.facoccmed.ac.uk).

cally searched the literature for studies involving subjects not seeking treatment. One third of the studies considered educational approaches, often including training in lifting techniques, finding

strong evidence that they were ineffective. Much of the remaining

literature studied lumbar supports and back belts, again, negative

findings.

The most telling finding of this review, however, is the lack of

control trials that consider job controls modifying so-called risk factors such as force of repetition. We simply do not have the scientific

evidence yet that these measures are effective.

I am not convinced that there is reliable evidence supporting

blanket ergonomics programs as a remedy for musculoskeletal disorders. In fact, a regulation not dissimilar to the issued proposal

was introduced in Europe in the early 1990s.

This has had no discernible influence on disability due to back

pain. It may well be better to target our resources towards appropriate management of the symptomatic worker, taking steps to remove obstacles to recovery, both physical and psychosocial, thus facilitating that worker’s continued comfortable performance of normal job duties.

PREPARED STATEMENT

Senator SPECTER. Dr. Burton, your time has expired and we have

to be very close on that with so many witnesses. Your full statement will be made part of the record. And if you would summarize,

we would appreciate it.

Dr. BURTON. That was it. I have finished, sir.

[The statement follows:]

PREPARED STATEMENT OF DR. KIM BURTON

It is a pleasure to address this body on the very controversial topic of ergonomics.

Recently in the United Kingdom, experts giving evidence in litigation cases need to

sign a declaration that their duty is to the Court rather than to the party instructing them. It is in this spirit that I present my views to you. My background encompasses both biomedical science and ergonomics. Currently, I am Director of the Spinal Research Unit at the University of Huddersfield in the United Kingdom and I

serve as Editor-in-Chief of Clinical Biomechanics, a biomedical journal listed in

Index Medicus. I am also a registered European Ergonomist, and have prepared reports and guidance for the Health & Safety Executive in the United Kingdom. Last

year, in collaboration with Professor Gordon Waddell, I produced what commentators have called the most comprehensive and current review of the evidence related

to occupational aspects of low back pain.1

The first question posed in this hearing is the nature of the problem, including:

‘‘What types of injuries?’’ and ‘‘Who suffers these injuries?’’ This very articulation,

however, oversimplifies the enquiry. It is vitally important to distinguish between

reports of symptoms, reports of alleged but medically untested ‘‘injuries’’ such as filing an injury claim, sick leave, chronicity, and irreparable damage—all of which are

brought together under the same umbrella. It is also important to recognize that

the term ‘‘musculoskeletal disorders’’ or ‘‘MSDs,’’ as discussed by OSHA, includes a

nearly innumerable body of reported conditions, some of which involve a discrete pathology whilst others are characterized only by their symptoms. Each of these components is unique, and it is somewhat unhelpful to talk about them as if they are

fully interchangeable. There is one common thread, however, and that is the compelling evidence of multifactorial influences, including those which are unrelated to

work.
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2 Institute for Research in Extramural Medicine, Free University, Amsterdam, Netherlands.

Because low back pain is the area of my expertise and is such a prominent target

of OSHA’s recent regulation, I will use this as an example. Low back pain is not

a discrete disease entity or even a single clinical syndrome; it is a symptom. Low

back pain, in fact, is a symptom experienced by most people during their lifetimes,

irrespective of employment. General adult population surveys find a lifetime prevalence of low back pain of around 60 percent, a 12-month prevalence of over 40 percent and a point prevalence of approximately 20 percent. The lifetime prevalence in

adolescents, at just over 50 percent, is only slightly lower than that for workingage adults. In the face of such figures, attribution of the bulk of the symptoms to

work is, in my view, untenable. It becomes exceedingly difficult to identify any specific causative agents.

Non-specific low back pain can be occupational in the sense that it is common in

adults of working age, frequently affects capacity for work and often prompts referral to occupational health care. The common assumption that this means low back

pain is caused by work, however, overlooks the complex and inconsistent relationship of physical and other influences. Workers in heavy manual jobs do report somewhat more low back symptoms and jobs with greater physical demands commonly

have a higher rate of reported low back injuries, but most of these ‘‘injuries’’ are

associated with normal everyday activities such as bending and lifting and there is

usually little if any objective evidence of tissue damage. The review I coauthored

with Professor Waddell, which considered 34 existing systematic reviews, 28 narrative reviews, 52 individual scientific studies, 22 additional weaker scientific studies and 17 previous guidelines. We concluded that the balance of the evidence

showed that physical demands of work can precipitate individual attacks of back

pain, certain individuals may be more susceptible and certain jobs may be higher

risk but, viewed overall, physical demands of work only account for a modest proportion of the total impact of back pain occurring in workers.

Whether low back symptoms are attributed to work, are reported as ‘‘injuries,’’ or

lead to requests for health care or time off of work depends upon a complex combination of individual psychosocial and work organisational factors. The development of chronic pain and disability depends more on individual and work-related

psychosocial issues than on physical or clinical features. People with physically or

psychologically demanding jobs may have more difficulty working when they have

low back pain and so lose more time from work, but that can be the effect rather

than the cause of their pain.

It is unrealistic to think, therefore, that we are even close to the point at which

we can expect to prevent low back pain. What I understand to be OSHA’s apparent

concept of making all work physically undemanding is not only unsupported, but

may well have adverse effects by exacerbating the psychosocial influences that are

now known to be important determinants of MSDs in the workplace. There is a

strong chance of raising the profile of the ‘‘attribution’’ concept among workers, their

advisors and managers, which in turn would likely lead to an exacerbation of the

overall impact of low back pain on society rather than a reduction.

The state-of-the-art evidence assessing reductions in physical exposures as a prescription for ergonomic concerns is a comprehensive review from Steven J. Linton

and Maurits van Tulder entitled ‘‘Preventive Interventions for Back and Neck Pain

Problems: What is the Evidence?’’ 2 The authors of this review systematically

searched the literature for investigations that specifically considered a preventative

intervention using randomized or non-randomized controlled trials involving subjects not seeking treatment. Twenty-seven such studies were found, none of which

focused on the physical workplace environment. One-third of the studies considered

educational approaches (often including training in lifting techniques), finding

‘‘strong evidence’’ that these ‘‘back schools’’ are ineffective. Much of the remaining

literature studied lumbar supports such as back belts, yielding consistently negative

findings. Exercise programs aimed at improving conditioning showed stable positive

evidence of relatively moderate utility, but issues such as compliance and individual

need suggest they are not justified for use as a universal remedy. The most telling

finding, however, is the lack of any controlled trials—randomized or otherwise—that

consider ‘‘job controls’’ modifying so-called ‘‘risk factors’’ such as force or repetition.

We simply do not have the scientific evidence yet that these measures are effective.

Such evidence, in my opinion, is essential. Anecdotal evidence of ergonomic ‘‘successes’’ is often cited, but these claims raise more questions than they answer. It

is difficult to determine in many cases exactly what the employer has done and how

that can be translated into a regulation. Another important issue is that such studies have used different measurements by which ‘‘success’’ is claimed (e.g. absence,

injury reports, prevalence rates). Interventions may be said to have some effect on
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absence rates, but in most cases these appear to be the outcome of organisationallybased factors such getting all the players on one side, rather than the product of

reductions in physical demands. Without any way to separate out and test these influences, which requires carefully designed controlled trials, it becomes impossible

to determine the optimal strategy.

Scientists have likewise been unable to develop any reliable quantified relationships between exposure to ‘‘risk factors’’ and negative health outcomes. We are simply not at the point yet where we can offer a legitimate work-damage model to guide

employer conduct, and we are unlikely to reach that point anytime soon. Ergonomics

researchers face particularly difficult challenges: measuring exposures in diverse

workplaces, accurately diagnosing the response for outcomes such as low back pain

that do not manifest objective tissue damage, and selecting interventions that might

offer benefit for substantial numbers of workers. Science, after considerable effort,

has failed to identify any instances where exposure-response relationships are universally agreed to be positively and accurately quantified. It is difficult to conceive

how a workable standard could be applied in the absence of such guidance.

I am not convinced that there is reliable evidence supporting blanket ergonomics

programs as a remedy for ‘‘MSDs.’’ It may well be proper to target resources toward

appropriate management of the symptomatic worker, taking steps to remove obstacles to recovery (both physical and psychosocial) by facilitating that worker’s continued comfortable performance of normal job duties. Even then, it is imperative that

physical measures be temporary and not a permanent crutch that will impede the

worker’s return to full function. Helping a worker get back to the job in this fashion,

however, is a far cry from using mandatory and potentially permanent job modifications to prevent injuries. The latter alternative, in my opinion, is scientifically unsupported and dangerously counterproductive. Whatever OSHA does as a next step,

therefore, I would hope it will not fall into the trap of continued fixation on physical

exposures as the key to solving the problem.

Senator SPECTER. Thank you. We should have begun with Dr.

Jeremiah Barondess, chairman of the MSD Panel, National Research Council, IOM, and president of the New York Academy of

Medicine. Thank you for joining us, Dr. Barondess. And the floor

is yours.

STATEMENT OF DR. JEREMIAH A. BARONDESS, CHAIRMAN, PANEL ON

MUSCULOSKELATAL DISORDERS AND THE WORKPLACE, AND

PRESIDENT OF THE NEW YORK ACADEMY OF MEDICINE

Dr. BARONDESS. Thank you very much, Senator. It is a privilege

to be here. On behalf of the panel, my statement is before you and

it will be included in the record. And I wish to emphasize a few

points in it in the course of this presentation.

This study was conducted by a panel put together by the National Academy of Sciences and it consisted of 19 nationally-recognized experts in the relevant scientific fields. The study took 2

years and was requested. It was requested of us at the outset that

it take 2 years. We had then ample opportunity to be comprehensive.

I wish to emphasize that what is presented in this report is not

the personal opinion of anyone.

Senator SPECTER. They gave you a deadline?

Dr. BARONDESS. They requested that we not hurry. I would put

it that way. Two years was the request.

Senator SPECTER. But they gave you a deadline?

Dr. BARONDESS. Yes, sir. Yes, sir. Once again, this report represents the synthesis of the best thinking of people expert in the

relevant fields. We were essentially asked to look only at the

science, not policy, and to answer two questions. The first is, does

the scientific evidence support the contention that the workplace

adds incremental risk of musculoskeletal disorders of the low back
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and upper extremities; not is it the entire cause of all such syndromes but is there incremental risk.

The second question was: Is there a scientific basis for the contention that interventions of some sorts and some circumstances

are effective. The answer to both questions is yes, in the view of

the committee.

I would like to emphasize that this review was rigorous, as it had

to be. A lot of the literature in this field is weak. Some of it is easy

to dismiss on scientific grounds.

The Commission reviewed more than 3,600 studies and reviews

relevant to the fields of mechanobiology, biomechanics and epidemiology as well as some clinical literature, and culled from those

papers some 25 percent so that there was a significant filter in the

literature that was reviewed.

In addition to the literature reviews, we had numerous informed

presentations by representatives of industry, of labor, and various

others.

The committee went to two heavy industry plants, kindly given

access by the Ford Motor Company, and visited those for a full day.

And finally, there were open fora for the expression of opinions by

industry, labor and professional bodies.

The conclusions of the 2-year study of the scientific basis that we

were asked to review can be very quickly summarized.

The first conclusion is as you have heard this is a very important

national health problem. It accounts for some 70 million office visits to physicians annually, not all of it obviously specifically workrelated. And it costs something of the order of 1 percent of the

gross domestic product of the nation.

Second, the question of whether it is possible to compare the incidents in the workforce to the incidents in the general population

cannot be approached. Because more than 80 percent of American

adults are in the workforce.

Third, the committee took the position that workplace disorders

and individual risk and outcomes are inextricably bound, and

therefore these disorders should be approached in the context of

the whole person rather than strictly the injured structure. It is

the structure that gets injured, it is person who gets disabled.

Additionally, the committee concluded that the weight of the evidence does justify the evidence, the identification of certain workrelated risk factors for the occurrence of musculoskeletal disorders.

For the low back these include heavy lifting, that is significant

physical loads, load moment, which is the distance from the person

at which the load to be lifted is positioned, frequent bending, twisting and whole body vibration; and for the upper extremity, repetition, force and vibration.

The committee concluded that psychosocial factors are in fact

also very important in addition to the physical factors. I appreciate

Mr. Fellner putting up two of our illustrations demonstrating the

complexity of human beings. The complexity of humans in these regards does not mean, however, that the problem cannot or should

not be approached.

The committee concluded also that the weight of the evidence

justifies the introduction of appropriate and selected interventions,
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that the scientific basis is there. It is not as robust as we would

like but it is sufficient for action.

Some of these interventions should apply ergonomic principles to

reduce physical as well as psychosocial stressors. These things have

to be applied carefully in a sharply selective manner, should be scientifically based and should be periodically evaluated.

There is no generic solution to these problems. They must be tailored to the specifics of the workplace and the tasks involved in the

job.

PREPARED STATEMENT

The committee also concluded that the entire field would benefit

from an enhanced information base. There is no science base anywhere that is complete. That includes this one. And additional research would help in the nuancing of responses. I thank you for

your attention, Mr. Chairman.

[The statement follows:]

PREPARED STATEMENT OF DR. JEREMIAH A. BARONDESS

Good morning, Mr. Chairman and members of the Committee. My name is Dr.

Jeremiah Baroness. I am the President of the New York Academy of Medicine and

Chairman of the Panel on Musculoskeletal Disorders and the Workplace. I am accompanied by committee member Dr. David Wegman, Professor and Chair of the

Department of Work Environment at the University of Massachusetts at Lowell.

PANEL COMPOSITION

The Panel on Musculoskeletal Disorders and the Workplace was established by

the National Research Council (NRC) and the Institute of Medicine (IOM) in January, 1999, to conduct a two-year study of the contribution of workplace physical and

psychosocial factors to the occurrence of musculoskeletal disorders of the low back

and upper extremities and to examine the effectiveness of various prevention strategies. The panel is composed of 19 experts representing the fields of biomechanics,

epidemiology, hand surgery, human factors engineering, internal medicine, nursing,

occupational medicine, orthopedics, physical medicine and rehabilitation, physiology,

psychology, quantitative analysis, and rheumatology.

IMPETUS

The impetus for the study was a request from Congress (including your subcommittee) to examine the causation, diagnosis, and prevention of musculoskeletal

disorders (House Report 105–635). The congressional request was presented in the

form of seven questions. The charge to the panel, prepared by the NRC and the

IOM, was stated as a series of tasks designed to provide a comprehensive review

of the science base and to address the issues outlined in the congressional questions.

A complete statement of the panel’s charge, approach, conclusions, and recommendations is found in the first attachment: the Executive Summary of the final

report. Attachment App. A provides the panel’s response to the congressional questions.

APPROACH

The panel approached the complex of factors bearing on the risk of musculoskeletal injury in the work setting from a whole-person perspective, that is, from

a point of view that does not isolate disorders of the low back and upper extremities

from physical and psychosocial factors in the workplace, from the context of the

overall texture of the worker’s life, including social support systems at work and in

the community and physical and psychosocial stresses outside the workplace, or

from personal responses to pain and individual coping mechanisms. The focus of the

study was on work-related factors. Individual factors and activities outside of the

workplace were considered as context and were accounted for in the literature reviews. Our task was to determine the incremental effect of work-related factors on

the occurrence of musculoskeletal disorders.
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The panel applied a set of rigorous scientific criteria in selecting the research

studies for its review. Because the literature includes both empirical and theoretical

approaches and covers a wide variety of research designs, measurement instruments, and methods of analysis, the quality selection criteria varied somewhat

among disciplines. At one level, there are highly controlled studies of soft tissue responses to specific exposures using cadavers, animal models, and human subjects.

At another level, there are surveys and other observational epidemiologic studies

that examine the association among musculoskeletal disorders and work, organizational, social, and individual factors. At yet another level, there are experimental

and quasi-experimental studies of human populations designed to examine the effects of workplace interventions. Studies at each level have attendant individual

strengths; each also has limitations when considered in isolation. When taken together however, they provide a rich basis for understanding the causes and prevention of musculoskeletal disorders.

DIMENSIONS OF THE PROBLEM

The first conclusion reached by the panel is that musculoskeletal disorders of the

low back and upper extremities are an important national health problem, resulting

in approximately 1 million people losing time from work each year. These disorders

impose a substantial economic burden in compensation costs, lost wages, and productivity. Conservative cost estimates vary, but a reasonable figure is about $50 billion annually in work-related costs—a figure representing approximately 1 percent

of GDP.

The panel found that estimates of incidence in the general population, as contrasted with the working population, are unreliable because more than 80 percent

of the adult population in the United States is in the workforce. Nevertheless, the

magnitude of the problem of work-related musculoskeletal disorders can be gleaned

from the Bureau of Labor Statistics data. These data suggest that musculoskeletal

disorders are a problem in multiple industrial sectors; they are not limited to the

traditional heavy labor environments represented by agriculture, mining, and manufacturing. It was reported, for example, that the service sector is also importantly

involved, accounting for 26 percent of sprains/strains, carpal tunnel syndrome, or

tendinitis; the manufacturing sector accounted for 22 percent. Another data base,

National Center for Health Statistics, using self reports, provided estimates for back

pain among those whose pain occurred at work (approximately 11.7 million) and for

those who specifically reported that their pain was work-related (5.6 million). In this

survey, the highest-risk occupations among men were construction laborers, carpenters, and industrial truck and tractor equipment operators; among women, the

highest-risk occupations were nursing aides/orderlies/attendants, licensed practical

nurses, maids, and janitor/cleaners. Other high-risk occupations were hairdressers

and automobile mechanics.

RELATIONSHIP AMONG WORK FACTORS AND MUSCULOSKELETAL DISORDERS

A second major conclusion is that the weight of the evidence justifies the identification of certain work-related risk factors for the occurrence of musculoskeletal disorders of the low back and upper extremities.

—The panel concludes that there is a clear relationship between back disorders

and physical load; that is, manual material handling, load moment, frequent

bending and twisting, heavy physical work, and whole-body vibration. For disorders of the upper extremities, repetition, force, and vibration are particularly

important work-related factors. That is, physical workplace activities have been

shown to be responsible for a significant increment in the occurrence of musculoskeletal disorders of the low back and upper extremities.

—Work-related psychosocial factors recognized by the panel to be associated with

low back disorders include rapid work pace, monotonous work, low job satisfaction, low decision latitude, and job stress. High job demands and high job stress

are work-related psychosocial factors that are associated with the occurrence of

upper extremity disorders.

THE VALUE OF WORKPLACE INTERVENTIONS

A third major conclusion is that the weight of the evidence justifies the introduction of appropriate and selected interventions in the workplace to reduce the risk

of musculoskeletal disorders of the low back and upper extremities. These include,

but are not confined to, the application of ergonomic principles to reduce physical

as well as psychosocial stressors. To be effective, intervention programs should include employee involvement, employer commitment, and the development of inte-
122

grated programs that address equipment design, work procedures, and organizational characteristics.

There is no generic solution. To be effective interventions must be tailored to the

specific work and worker conditions and must be evaluated on a continuing basis

to account for changing workplace and worker factors.

Cost and effectiveness of various intervention strategies are a major concern for

public and private policy makers, managers, and other leaders facing the practical

challenges of allocating limited resources. Despite the availability of cost benefit

analysis techniques they have not been systematically applied to the study of workplace interventions designed to relieve or prevent musculoskeletal disorders. Outcome measures generally include relief from pain and loss of function and reductions

in worker’s compensation claims and time away from work. Although there are individual studies that demonstrate favorable outcomes following the introduction of an

intervention, the conditions under which the data are collected make it difficult to

determine which of several specific factors are responsible for the outcome. On the

other side of the equation are the costs associated with the design and implementation of the interventions. Some interventions require minor changes in procedures

or layouts for specific work spaces while others may involve developing large-scale

design modifications or instituting new work practices or ways to organize work.

Here again, some scattered individual studies exist. What is needed to resolve these

issues is careful research to develop a methodology to facilitate both cost and benefit

comparisons across alternative interventions in a range of workplaces.

THE NEED FOR DATA COLLECTION AND REPORTING SYSTEMS

To extend the current knowledge base relating both to risk and effective interventions, the Bureau of Labor Statistics should continue to revise its current data collection and reporting system to provide more comprehensive surveillance of workrelated musculoskeletal disorders. Specific attention should be given to revising the

illness and injury coding system, refining the quantification of risk, and developing

denominator data for job-specific demographic features. Reporting should also be enhanced to include details on musculoskeletal disorders that do not involve lost workdays. Enhanced resources are needed to address these recommendations.

The National Center for Health Statistics and the National Institute for Occupational Safety and Health should include measures of work exposures and musculoskeletal disorder outcomes in ongoing Federal surveys (e.g., the National Health

Interview Surveys, the National Health and Nutritional Examinations), and NIOSH

should repeat, at least decennially, the National Occupational Exposure Survey.

NIOSH should develop both a passive surveillance packages for use by a broad

range of employees and a model for an active surveillance program for interested

employers.

The National Institute for Occupational Safety and Health should take the lead

in developing uniform definitions of musculoskeletal disorders for use in clinical diagnosis, epidemiologic research, and data collection for surveillance systems. These

definitions should (1) include clear and consistent endpoint measures, (2) agree with

consensus codification of clinically relevant classification systems, and (3) have a biological and clinical basis.

A RESEARCH AGENDA

The panel recommends a research agenda that includes developing (1) improved

tools for exposure assessment, (2) improved measures of outcomes and case definitions for use in epidemiologic and intervention studies, and (3) further quantification of the relationship between exposures and outcomes. Also included are suggestions for studies in each topic area: tissue mechanobiology, biomechanics, psychosocial stressors, epidemiology, and workplace interventions. In addition, the panel

recommends (1) expanding research and research training, (2) promoting collaboration among industry, labor, and academia, and (3) expanding education and training

in utilizing workplace interventions to employers. In order to accomplish these objectives, the panel recognized that funding for NIOSH would have to be significantly

increased. Broader support for these research programs should also be sought from

relevant NIH Institutes.

THE DISSENT

The conclusions and recommendations provided in the panel’s report were supported by 18 of the 19 panel members. The dissenting member, a hand surgeon, prepared a statement that was limited to a very narrow concern—the relationship between carpal tunnel syndrome and keyboarding. Unfortunately, he uses this case to

question the scientific basis for the panel’s review and interpretation of all of the
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literature. Essentially, he asserts that because the relationship between low force,

high repetition activities and muscusloskeletal disorders is weak, the relationship

between any work and the occurrence of a musculoskeletal disorder may not be

sound.

Some key points in the dissent assert that the panel used an unscientific approach to the literature review, that it over-reached in interpreting the literature

on the relationship between keyboarding and carpal tunnel syndrome, and that it

recommends ergonomics as an exclusive remedy for musculoskeletal disorders. All

of these assertions are countered in the panel’s response to the dissent (see Attachment App. C). It is important to note that many of the research studies cited by

the dissenting member in his discussion of the epidemiology of carpal tunnel syndrome and work did not meet the rigorous review criteria established by the panel

and were rejected for inclusion in the full report. Furthermore, one of the 18 panel

members is a leading and highly regarded hand surgeon and an enthusiastic supporter of the panel’s conclusions and recommendations.

Mr. Chairman, I want to thank you for the opportunity to provide testimony on

this important topic. I will be happy to answer any questions.

MUSCULOSKELETAL DISORDERS AND THE WORKPLACE—LOW BACK AND UPPER

EXTREMITIES

EXECUTIVE SUMMARY

There is no doubt that musculoskeletal disorders of the low back and upper extremities are an important and costly national health problem. Musculoskeletal disorders account for nearly 70 million physician office visits in the United States annually and an estimated 130 million total health care encounters including outpatient, hospital, and emergency room visits. In 1999, nearly 1 million people took

time away from work to treat and recover from work-related musculoskeletal pain

or impairment of function in the low back or upper extremities. Conservative estimates of the economic burden imposed, as measured by compensation costs, lost

wages, and lost productivity, are between $45 and $54 billion annually. There is

some variation in estimates of occurrence and cost as a result of inconsistencies

within and across existing databases. The ability to better characterize the magnitude of the problem and formulate targeted prevention strategies rests on improved surveillance and more rigorous data collection.

There is also debate concerning sources of risk, mechanisms of injury, and the potential for intervention strategies to reduce these risks. The debate focuses on the

causes, nature, severity, and degrees of work-relatedness of musculoskeletal disorders as well as the effectiveness and cost-related benefits of various interventions.

None of the common musculoskeletal disorders is uniquely caused by work exposures. They are what the World Health Organization calls ‘‘work-related conditions’’

because they can be caused by work exposures as well as non-work factors. There

are a number of factors to be considered: (1) physical, organizational, and social aspects of work and the workplace, (2) physical and social aspects of life outside the

workplace, including physical activities (e.g., household work, sports, exercise programs), economic incentives, and cultural values, and (3) the physical and psychological characteristics of the individual. The most important of the latter include

age, gender, body mass index, personal habits including smoking, comorbidities, and

probably some aspects of genetically determined predispositions. In addition, physical activities away from the workplace may also cause musculoskeletal syndromes;

the interaction of such factors with physical and psychosocial stresses in the workplace is a further consideration. The task herein is to evaluate the significance of

the risk factors that result from work exposure while taking into account the different types of individual and non-work factors. The complexity of the problem is

further increased because all of these factors interact and vary over time and from

one situation to another. Research is needed to clarify such relationships, but research is complicated by the fact that estimates of incidence in the general population, as contrasted with the working population, are unreliable because the two

overlap: more than 80 percent of the adult population is in the workforce.

The panel approached the complex of factors bearing on the risk of musculoskeletal injury in the work setting from a whole-person perspective, that is, from

a point of view that does not isolate disorders of the low back and upper extremities

from physical and psychosocial factors in the workplace, from the context of the

overall texture of the worker’s life, including social support systems and physical

and psychosocial stresses outside the workplace, or from personal responses to pain

and individual coping mechanisms (see Figure ES.1). The size and complexity of the

problem and the diversity of interests and perspectives—including those of medical
124

and public policy professionals, behavioral researchers, ergonomists, large and small

businesses, labor, and government agencies—have led to differing interpretations of

the evidence regarding the work-relatedness of musculoskeletal disorders of the low

back and upper extremities and the impact of interventions. As a result, Congress

requested a study by the National Research Council and the Institute of Medicine

covering the scientific literature on the causation and prevention of these disorders.

The congressional request was presented in the form of seven questions, which are

addressed in Appendix A of this report. The funding for the study was provided by

the National Institute for Occupational Safety and Health (NIOSH) and by the National Institutes of Health (NIH).

Figure ES.1.—A conceptual model of the possible roles and influences that various factors may

play in the development of musculoskeletal disorders. The dotted box outline on the right indicate the possible pathways and processes that could occur within the person, including the biomechanical load-tolerance relationship and the factors that may mediate the load-tolerance relationship, such as individual factors and adaptation. Outcomes may be a result of this relationship and may be influenced by individual factors, such as conditioning or psychological state.

The dotted box on the left indicates the possible influences of the workplace on the sequence

of events that can lead to musculoskeletal disorders in the person. Arrows between ‘‘the workplace’’ factors and ‘‘the person’’ box indicate the various research disciplines (epidemiology, biomechanics, physiology, etc.) that have attempted to explain the relationship. For example, epidemiology typically searches for associations between external loading characteristics and reported

outcomes, whereas the relationship between external loads and biomechanical loading are usually explored via biomechanical studies (adapted from National Research Council, 1999b).
125

PANEL CHARGE, COMPOSITION, AND APPROACH

The charge to the panel from NIOSH and NIH, which appears in Box ES.1, was

to undertake a series of tasks that would lead to a detailed analysis of the complex

set of factors contributing to the occurrence in the workplace of musculoskeletal disorders of the low back and upper extremities and that would provide the information necessary to address the questions posed by Congress. The panel viewed this

charge as an opportunity to conduct a comprehensive review and interpretation of

the scientific literature, with the goal of clarifying the state of existing knowledge

concerning the roles of various risk factors and the basis for various efforts bearing

on prevention. The focus of the study was on work-related factors. In this context,

individual risk factors, such as age, body mass index, gender, smoking, and activities outside the workplace, were considered as sources of confounding and were accounted for in the research reviews.

The panel was composed of 19 experts representing the fields of biomechanics, epidemiology, hand surgery, human factors engineering, internal medicine, nursing,

occupational medicine, orthopedics, physical medicine and rehabilitation, physiology,

psychology, quantitative analysis, and rheumatology. The panel’s work was guided

by two underlying principles. The first, noted above, was to approach musculoskeletal disorders in the context of the whole person rather than focusing on body

regions in isolation. The second was to draw appropriate scientific inferences from

basic tissue biology, biomechanics, epidemiology, and intervention strategies in

order to develop patterns of evidence concerning the strength of the relationship between musculoskeletal disorders and the multiplicity of work and individual factors.

The panel applied a set of rigorous scientific criteria in selecting the research

studies for its review. Because the literature includes both empirical and theoretical

approaches and covers a wide variety of research designs, measurement instruments, and methods of analysis, the quality selection criteria varied somewhat

among disciplines (see Chapter 1 for details). At one level, there are highly con-
126

trolled studies of soft tissue responses to specific exposures using cadavers, animal

models, and human subjects. At another level, there are surveys and other observational epidemiologic studies that examine the association among musculoskeletal

disorders and work, organizational, social, and individual factors. At yet another

level, there are experimental and quasi-experimental studies of human populations

designed to examine the effects of workplace interventions. Each level provides a

different perspective; together they provide a complementary picture of how various

workplace exposures may contribute to the occurrence of musculoskeletal disorders.

Although each level has its attendant strengths and limitations when considered

alone, together they provide a rich understanding of the causes and prevention of

musculoskeletal disorders.

The wide and diverse body of literature addressing the work-relatedness of musculoskeletal disorders suggests various pathways to injury. Figure ES.1 summarizes

the analytic framework used by the panel to organize and interpret these various

strands of research. This framework is central to the panel’s assessment, and it is

used to orient and structure the panel’s report. The factors are organized into two

broad categories: workplace factors and characteristics of the person that may affect

the development of musculoskeletal disorders. Workplace factors include the external physical loads associated with job performance, as well as organizational factors

and social context variables. A person is the central biological entity, subject to biomechanical loading with various physical, psychological, and social features that

may influence the biological, clinical, and disability responses. The rationale underlying the figure is that there may be many pathways to injury, and the presence

of one pathway does not negate nor suggest that another pathway does not play an

important role. The various pathways simply represent different aspects of the

workplace-person system.

PATTERNS OF EVIDENCE

The panel’s review of the research literature in epidemiology, biomechanics, tissue

mechanobiology, and workplace intervention strategies has identified a rich and consistent pattern of evidence that supports a relationship between the workplace and

the occurrence of musculoskeletal disorders of the low back and upper extremities.

This evidence suggests a strong role for both the physical and psychosocial aspects

of work. There is also evidence that individual factors, such as age, gender, and

physical condition, are important in mediating the individual’s response to work factors associated with biomechanical loading.

Back disorders and the workplace

Low back disorder risk has been established through epidemiologic studies of

work that involves heavy lifting, frequent bending and twisting, and whole body vibration, as well as other risk factors. The relative risks have been derived from a

rigorous evaluation of the literature and have been found to be strong and consistent. Strong points in this research include control for confounding, temporal association, and characterization of dose-response relationships; the principal limitation is that a number of the studies are based on self-reports of injury. The epidemiologic literature that specifically quantifies heavy lifting shows the greatest

risk for injury when loads are lifted from low heights, when the distance of the load

from the body (moment) is great, and when the torso assumes a flexed, asymmetric

posture. Biomechanical studies reinforce the epidemiologic findings. Studies in basic

biology also describe the mechanisms involved in the translation of spinal loading

to tissue injury within the intervertebral disc. In addition, the basic science literature has described pathways for the perception of pain when specific structures

in the spine are stressed. Intervention studies have shown how lift tables and lifting

hoists are effective in mediating the risk of low back pain in industrial settings.

Since risk is lowered when the load is changed from a heavy lift to a light lift, this

finding is also consistent with the rigorous epidemiologic findings.

In epidemiologic studies, psychosocial factors in the workplace have also been

found to play a role. Specifically, there is evidence for a relationship between low

back disorders and job satisfaction, monotonous work, work pace, interpersonal relations in the workplace, work demand stress, and the worker’s perceived ability to

work. In addition, recent evidence from biomechanics studies points to a mechanism

whereby psychosocial stress contributes to increases in spine loading. There is also

evidence that exposure to psychosocial stressors may result in greater trunk muscle

activity independent of biomechanical load. Some part of the variance in response

described in the biological and biomechanical literature appears to be explained by

individual host factors, such as age, gender, and body mass index. For example, age

and gender appear to play a role in determining the magnitude of load to which a

person’s spine may be exposed before damage would be expected.
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Upper extremity disorders and the workplace

The pattern of evidence for upper extremity disorders, as for the low back, also

supports an important role for physical factors, particularly repetition, force, and vibration. The most dramatic physical exposures occur in manufacturing, food processing, lumber, transportation, and other heavy industries, and these industries

have the highest rates of upper extremity disorders reported as work related. Psychosocial factors were found to play a role in upper extremity disorders as well, particularly high job stress and high job demands. In addition, several epidemiologic

studies of physical exposures (force, repetition) and psychosocial exposure (perceived

stress, job demands) have documented an elevated risk of upper extremity disorders

among computer users. Nonwork-related anxiety, tension, and psychological distress

are also associated with upper extremity symptoms. Biomechanical studies have

shown that extraneural pressure in the carpal tunnel is increased with hand loading

and nonneutral wrist postures. Basic science studies demonstrate that extraneural

pressures may lead to intraneural edema and fibrosis, demyelination, and axon degeneration. These changes in nerve structure may cause impairment of nerve function. The findings in the intervention literature are congruent with those in the

basic biology and epidemiology literatures. There is strong support across these bodies of work that high force and repetition are associated with musculoskeletal disorders of the upper extremities; basic biology data provide evidence of alteration in

tissue structure. The intervention literature supports the efficacy of tool and

workstation design changes, job rotation, and other interventions that directly address these risk factors with regard to upper extremity symptomology.

Although the upper extremity literature is less well developed than the literature

on low back pain, an analogous set of themes emerges, lending further support to

the conclusion that external loads and psychosocial factors associated with work influence outcomes. These exposure-response associations persist when adjusted for

individual factors that may increase vulnerability, such as age, gender, and body

mass index. The basic biology and biomechanics studies provide a plausible basis

for the exposure-response relationships. The evidence related to the efficacy of ergonomic interventions further supports these relationships.

Interventions

Data from scientific studies of primary and secondary interventions indicate that

low back pain can be reduced under certain conditions by engineering controls (e.g.,

ergonomic workplace redesign), administrative controls (specifically, adjusting organizational culture), programs designed to modify individual factors (specifically, employee exercise), and combinations of these approaches. Multiple interventions that

actively involve workers in medical management, physical training, and work technique education can also be effective in controlling risk. Similarly, with respect to

interventions for musculoskeletal disorders of the upper extremities, some studies

of engineering controls for computer-related work (reducing static postural loads,

sustained posture extremes, and rapid motions, and changing the designs of

workstations and tools) have resulted in a decrease in upper extremity pain reports.

Studies of administrative controls (modifying organizational culture by an emphasis

on participatory team involvement) have also reported success. For such interventions, the commitment of management and the involvement of employees have been

important to success.

These findings are based on a research and development process that tailors

interventions to specific work and worker conditions and evaluates, on a continuing

basis, the effectiveness of these interventions in the face of changing workplace and

worker factors. It is therefore neither feasible nor desirable to propose a generic solution. The development and application of effective interventions requires an infrastructure that supports (1) gathering data, through surveillance and research, about

the engineering, administrative, and worker factors that affect the effectiveness of

interventions; (2) using these data to refine, implement, and assess alternative

interventions; and (3) translating knowledge from research to practice. These efforts

will benefit from cooperation and information exchange among researchers, practitioners, and workers and managers in industry and labor, government, and academia. These practices should be encouraged and extended.

CONCLUSIONS

Based on a comprehensive review and analysis of the evidence, as described

above, the panel has reached the following conclusions:

1. Musculoskeletal disorders of the low back and upper extremities are an important national health problem, resulting in approximately 1 million people losing

time from work each year. These disorders impose a substantial economic burden
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in compensation costs, lost wages, and productivity. Conservative cost estimates

vary, but a reasonable figure is about $50 billion annually in work-related costs.

2. Estimates of incidence in the general population, as contrasted with the working population, are unreliable because more than 80 percent of the adult population

in the United States is in the workforce.

3. Because workplace disorders and individual risk and outcomes are inextricably

bound, musculoskeletal disorders should be approached in the context of the whole

person rather than focusing on body regions in isolation.

4. The weight of the evidence justifies the identification of certain work-related

risk factors for the occurrence of musculoskeletal disorders of the low back and

upper extremities.

—The panel concludes that there is a clear relationship between back disorders

and physical load; that is, manual material handling, load moment, frequent

bending and twisting, heavy physical work, and whole-body vibration. For disorders of the upper extremities, repetition, force, and vibration are particularly

important work-related factors.

—Work-related psychosocial factors recognized by the panel to be associated with

low back disorders include rapid work pace, monotonous work, low job satisfaction, low decision latitude, and job stress. High job demands and high job stress

are work-related psychosocial factors that are associated with the occurrence of

upper extremity disorders.

5. A number of characteristics of the individual appear to affect vulnerability to

work-related musculoskeletal disorders, including increasing age, gender, body mass

index, and a number of individual psychosocial factors. These factors are important

as contributing and modifying influences in the development of pain and disability

and in the transition from acute to chronic pain.

6. Modification of the various physical factors and psychosocial factors could reduce substantially the risk of symptoms for low back and upper extremity disorders.

7. The basic biology and biomechanics literatures provide evidence of plausible

mechanisms for the association between musculoskeletal disorders and workplace

physical exposures.

8. The weight of the evidence justifies the introduction of appropriate and selected

interventions to reduce the risk of musculoskeletal disorders of the low back and

upper extremities. These include, but are not confined to, the application of ergonomic principles to reduce physical as well as psychosocial stressors. To be effective,

intervention programs should include employee involvement, employer commitment,

and the development of integrated programs that address equipment design, work

procedures, and organizational characteristics.

9. As the nature of work changes in the future, the central thematic alterations

will revolve around the diversity of jobs and of workers. Although automation and

the introduction of a wide variety of technologies will characterize work in the future, manual labor will remain important. As the workforce ages and as more

women enter the workforce, particularly in material handling and computer jobs,

evaluation of work tasks, especially lifting, lowering, carrying, prolonged static posture, and repetitive motion, will be required to guide the further design of appropriate interventions.

RECOMMENDATIONS

1. The consequences of musculoskeletal disorders to individuals and society and

the evidence that these disorders are to some degree preventable justify a broad,

coherent effort to encourage the institution or extension of ergonomic and other preventive strategies. Such strategies should be science based and evaluated in an ongoing manner.

2. To extend the current knowledge base relating both to risk and effective interventions, the Bureau of Labor Statistics should continue to revise its current data

collection and reporting system to provide more comprehensive surveillance of workrelated musculoskeletal disorders.

—The injury or illness coding system designed by the Bureau of Labor Statistics

should be revised to make comparisons possible with health survey data that

are based on the widely accepted ICD–9 and ICD–10 coding systems.

—The characterization of exposures associated with musculoskeletal disorders

should be refined, including enhanced quantification of risk factors. Currently,

exposure is based only on characterization of sources of injury (e.g., tools, instruments, equipment) and type of event (e.g., repetitive use of tools) derived

from injury narratives.
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—Information collected from each employer should contribute to specificity in denominators for jobs including job-specific demographic features in the workplace, such as age, gender, race, time on the job and occupation.

—Injury and illness information should include, in addition to the foregoing demographic variables, other critical variables, such as event, source, nature, body

part involved, time on job, and rotation schedule. Combining these with the

foregoing variables would, with appropriate denominator information, allow calculation of rates rather than merely counts or proportions, as is now the case

for all lost-workday events.

—Resources should be allocated to include details on non-lost-workday injuries or

illnesses (as currently provided on lost-workday injuries) to permit tracking of

these events in terms of the variables now collected only for lost-workday injuries (age, gender, race, occupation, event, source, nature, body part, time on

job).

3. The National Center for Health Statistics and the National Institute for Occupational Safety and Health should include measures of work exposures and musculoskeletal disorder outcomes in ongoing Federal surveys (e.g., the National Health

Interview Surveys, the National Health and Nutritional Examinations), and NIOSH

should repeat, at least decennially, the National Occupational Exposure Survey.

—To upgrade and improve passive industry surveillance of musculoskeletal disorders and workplace exposures, the National Institute for Occupational Safety

and Health should develop adaptable surveillance packages with associated

training and disseminate these to interested industries.

—To provide more active surveillance opportunity, the National Institute for Occupational Safety and Health should develop a model surveillance program that

provides ongoing and advanced technical assistance with timely, confidential

feedback to participating industries.

4. The National Institute for Occupational Safety and Health should take the lead

in developing uniform definitions of musculoskeletal disorders for use in clinical diagnosis, epidemiologic research, and data collection for surveillance systems. These

definitions should (1) include clear and consistent endpoint measures, (2) agree with

consensus codification of clinically relevant classification systems, and (3) have a biological and clinical basis.

5. In addition to these recommendations, the panel recommends a research agenda that includes developing (1) improved tools for exposure assessment, (2) improved

measures of outcomes and case definitions for use in epidemiologic and intervention

studies, and (3) further quantification of the relationship between exposures and

outcomes. Also included are suggestions for studies in each topic area: tissue

mechanobiology, biomechanics, psychosocial stressors, epidemiology, and workplace

interventions. The research agenda is presented in Chapter 12.

ADDITIONAL CONSIDERATIONS

Because of the importance of continued data collection and research to further

elucidate the causes and prevention of musculoskeletal disorders of the low back

and upper extremities, the panel believes it would be useful for relevant government

agencies, including the National Institute for Occupational Safety and Health, the

Occupational Safety and Health Administration, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases to consider the following program initiatives.

1. Expanding research support and mechanisms to study musculoskeletal disorders in terms of risk factors at work, early detection, and effective methods of prevention and their cost effectiveness. Some examples include:

—Developing new mechanisms and linkages among funding agencies (e.g., the National Institute for Occupational Safety and Health, the National Institute of

Arthritis and Musculoskeletal and Skin Diseases) to expand ongoing basic research on relevant tissues (e.g., skeletal muscle, tendon, peripheral nerve) to

promote study of those parameters that are directly relevant to work-related

musculoskeletal disorders.

—Creating mechanisms to stimulate collaboration and cross-training of researchers in the basic and applied sciences directly relevant to work-related musculoskeletal disorders.

—Developing mechanisms to promote research jointly conducted by industry and

the relevant academic disciplines on work-related musculoskeletal disorders.

2. Expanding considerably research training relevant to musculoskeletal disorders, particularly with relation to graduate programs in epidemiology, occupational health, occupational psychology, and ergonomics, to produce additional individuals with research training.
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3. Expanding education and training programs to assist workers and employers

(particularly small employers) in understanding and utilizing the range of possible

workplace interventions designed to reduce musculoskeletal disorders. In addition,

consideration should be given to expanding continuing education (e.g., NIOSH Education and Research and Training Projects) for a broad range of professionals concerning risk factors that contribute to musculoskeletal disorders inside and outside

the workplace.

4. Developing mechanisms for cooperative studies among industry, labor unions,

and academia, including:

—Establishing a database of and mechanism for communicating ‘‘best practices.’’

—Providing incentives for industry and union cooperation with due regard for proprietary considerations and administrative barriers.

—Encouraging funding for such studies from industry, labor, academia, and government sources.

5. Revising administrative procedures to promote joint research funding among

agencies.

6. Encouraging the exchange of scientific information among researchers interested in intervention research through a variety of mechanisms. Areas that could

benefit include the development of (1) research methodologies, especially improved

measurement of outcomes and exposures, covariates, and costs and (2) uniform approaches, allowing findings to be compared across studies. In addition, periodic

meetings should be considered to bring together individuals with scientific and ‘‘best

practices’’ experience.

In order to implement these suggestions, the scope of research and training activities of the National Institute for Occupational Safety and Health would have to be

expanded and funding significantly increased. In addition, other Federal agencies

(e.g., the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the

National Institute of Mental Health) would have to broaden their support of research programs examining musculoskeletal disorders and the workplace. In the

panel’s view these steps deserve serious consideration.

APPENDIX A.—ANSWERS TO QUESTIONS POSED BY CONGRESS

The questions below provided the impetus for the study. The charge to the panel,

prepared by the NRC and the IOM was to conduct a comprehensive review of the

science base and to address the issues outlined in the questions. The panel’s responses to the questions follow.

Question. What are the conditions affecting humans that are considered to be

work-related musculoskeletal disorders?

Answer. The disorders of particular interest to the panel, in light of its charge,

focus on the low back and upper extremities. With regard to the upper extremities,

these include rotator cuff injuries (lateral and medial) epicondylitis, carpal tunnel

syndrome, tendinitis, tenosynovitis of the hand and wrist (including DeQuervains’

stenosing tenosynovitis, trigger finger, and others) and a variety of nonspecific wrist

complaints, syndromes, and regional discomforts lacking clinical specificity. With regard to the low back, there are many disabling syndromes that occur in the absence

of defined radiographic abnormalities or commonly occur in the presence of unrelated radiographic abnormalities. Thus, the most common syndrome is nonspecific

backache. Other disorders of interest include back pain and sciatica due to displacement and degeneration of lumbar intervertebral discs with radiculopathy,

spondylolysis, and spondylolisthesis, and spinal stenosis (ICD 9 categories 353–357,

722–724, and 726–729).

Question. What is the status of medical science with respect to the diagnosis and

classification of such conditions?

Answer. Diagnostic criteria for some of the musculoskeletal disorders considered

to be work-related and considered in this report are clear-cut, especially those that

can be supported by objective ancillary diagnostic tests, such as carpal tunnel syndrome. Others, such as work-related low back pain, are in some instances supported

by objective change, which must be considered in concert with the history and physical findings. In the case of radicular syndromes associated with lumbar

intervertebral disc herniation, for example, clinical and X-ray findings tend to support each other. In other instances, in the absence of objective support for a specific

clinical entity, diagnostic certainty varies but may nevertheless be substantial. The

clinical picture of low back strain, for example, while varying to some degree, is reasonably characteristic.

Epidemiologic definitions for musculoskeletal disorders, as for infectious and other

reportable diseases, are based on simple, unambiguous criteria. While these are

suitable for data collection and analysis of disease occurrence and patterns, they are
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not appropriate for clinical decisions, which must also take into account personal,

patient-specific information, which is not routinely available in epidemiologic databases.

Question. What is the state of scientific knowledge, characterized by the degree

of certainty or lack thereof, with regard to occupational and nonoccupational activities causing such conditions?

Answer. The panel has considered the contributions of occupational and nonoccupational activities to the development of musculoskeletal disorders via independent literature reviews based in observational epidemiology, biomechanics, and

basic science. As noted in the chapter on epidemiology, when studies meeting stringent quality criteria are used, there are significant data to show that both low back

and upper extremity musculoskeletal disorders can be attributed to workplace exposures. Across the epidemiologic studies, the review has shown both consistency and

strength of association. Concerns about whether the associations might be spurious

have been considered and reviewed. Biological plausibility for the work-relatedness

of these disorders has been demonstrated in biomechanical and basic science studies, and further evidence to build causal inferences has been demonstrated in intervention studies that show reduction in occurrence of musculoskeletal disorders following implementation of interventions. The findings suggest strongly that there is

an occupational component to musculoskeletal disorders. Each set of studies has inherent strengths and limitations that affect confidence in the conclusions; as discussed in Chapter 3 (methodology), when the pattern of evidence is considered

across the various types of studies, complementary strengths are demonstrated.

These findings were considered collectively through integration of the information

across the relevant bodies of scientific evidence. Based on this approach, the panel

concludes, with a high degree of confidence, that there is a strong relationship between certain work tasks and the risk of musculoskeletal disorders.

Question. What is the relative contribution of any causal factors identified in the

literature to the development of such conditions in (a) the general population, (b)

specific industries, and (c) specific occupational groups?

Anwer.

Individual Risk Factors

Because 80 percent of the American adult population works, it is difficult to define

a ‘‘general population’’ that is different from the working population as a whole. The

known risk factors for musculoskeletal disorders include the following:

Age.—Advancing age is associated with more spinal complaints, hand pain, and

other upper extremity pain, e.g., shoulder pain. Beyond the age of 60, these complaints increase more rapidly in women than men. The explanation for spinal pain

is probably the greater frequency of osteoporosis in women than in men. The explanation for hand pain is probably the greater prevalence of osteoarthritis affecting

women. However, other specific musculoskeletal syndromes do not show this trend.

For example, the mean age for symptomatic presentation of lumbar disc herniation

is 42 years; thereafter, there is a fairly rapid decline in symptoms of that disorder.

Gender.—As noted above, there are gender differences in some musculoskeletal

disorders, most particularly spinal pain due to osteoporosis, which is more commonly found in women than in men, and hand pain due to osteoarthritis, for which

there appears to be a genetic determinant with increased incidence in daughters of

affected mothers.

Healthy lifestyles.—There is a general belief that the physically fit are at lower

risk for musculoskeletal disorders; there are few studies, however, that have shown

a scientific basis for that assertion. There is evidence that reduced aerobic capacity

is associated with some musculoskeletal disorders, specifically low back pain and,

possibly, lumbar disc herniations are more common in cigarette smokers. Obesity,

defined as the top fifth quintile of weight, is also associated with a greater risk of

back pain. There currently is little evidence that reduction of smoking or weight reduction reduces the risk.

Other exposures.—Whole-body vibration from motor vehicles has been associated

with an increase in risk for low back pain and lumbar disc herniation. There is also

evidence that suboptimal body posture in the seated position can increase back pain.

Some evidence suggests that altering vibrational exposure through seating and improved seating designs to optimize body posture (i.e., reduce intradiscal pressure)

can be beneficial.

Other diseases.—There is a variety of specific diseases found in the population

that predispose to certain musculoskeletal disorders. Among the more common are

diabetes and hypothyroidism, both associated with carpal tunnel syndrome.
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Work-Related Risk Factors

Chapter 4 of this report explores the enormous body of peer-reviewed data on epidemiologic studies relevant to this question. Detailed reviews were conducted of

those studies judged to be of the highest quality based on the panel’s screening criteria (presented in the introduction and in Chapter 4). The vast majority of these

studies have been performed on populations of workers in particular industries in

which workers exposed to various biomechanical factors were compared with those

not exposed for evidence of symptoms, signs, laboratory abnormalities, or clinical diagnoses of musculoskeletal disorders. A small number of studies have been performed in sample groups in the general population, comparing individuals who report various exposures with those who do not.

The principal findings with regard to the roles of work and physical risk factors

are:

—Lifting, bending and twisting and whole-body vibration have been consistently

associated with excess risk for low back disorders, with relative risks of 1.2 to

9.0 compared with workers in the same industries without these factors.

—Awkward static postures and frequent repetitive movements have been less consistently associated with excess risk. For disorders of the upper extremity, vibration, force, and repetition have been most strongly and consistently associated with relative risks ranging from 2.3 to 84.5.

The principal findings with regard to the roles of work and psychosocial risk factors are:

—High job demand, low job satisfaction, monotony, low social support, and high

perceived stress are important predictors of low back musculoskeletal disorders.

—High job demand and low decision latitude are the most consistent of these factors associated with increased risk for musculoskeletal disorders of the upper

extremities.

—In addition, in well-studied workforces, there is evidence that individual psychological factors may also predispose to risk, including anxiety and depression,

psychological distress, and certain coping styles. Relative risks for these factors

have been generally less than 2.0.

Question. What is the incidence of such conditions in (a) the general population,

(b) specific industries, and (c) specific occupational groups?

Answer. There are no comprehensive national data sources capturing medically

defined musculoskeletal disorders, and data available regarding them are based on

individual self-reports in surveys. Explicitly, these reports include work as well as

nonwork-related musculoskeletal disorders without distinction; therefore, rates derived from these general population sources cannot be considered in any sense

equivalent to rates for background, reference, or unexposed groups, nor conversely,

as rates for musculoskeletal disorders associated with any specific work or activity.

There are no comprehensive data available on occupationally unexposed groups and,

given the proportion of adults now in the active U.S. workforce, any such nonemployed group would be unrepresentative of the general adult population. According the 1997 report from the National Arthritis Data Workgroup (Lawrence, 1998),

a working group of the National Institute of Arthritis and Musculoskeletal and Skin

Diseases, 37.9 million Americans, or 15 percent of the entire U.S. population, suffered from one or more chronic musculoskeletal disorders in 1990 (these data cover

all musculoskeletal disorders). Moreover, given the increase in disease rates and the

projected demographic shifts, they estimate a rate of 18.4 percent or 59.4 million

by the year 2020. In summary, data from the general population of workers and

nonworkers together suggest that the musculoskeletal disorders problem is a major

source of short- and long-term disability, with economic losses in the range of 1 percent of gross domestic product. A substantial portion of these are disorders of the

low back and upper extremities.

The Bureau of Labor Statistics (BLS) data, while suffering a number of limitations, are sufficient to confirm that the magnitude of work-related musculoskeletal

disorders is very large and that rates differ substantially among industries and occupations, consistent with the assumption that work-related risks are important

predictors of musculoskeletal disorders. BLS recently estimated 846,000 lost-workday cases of musculoskeletal disorders in private industry. Manufacturing was responsible for 22 percent of sprains/strains, carpal tunnel syndrome, or tendinitis,

while the service industry accounted for 26 percent. Examining carpal tunnel syndrome alone, manufacturing, transportation, and finance all exceeded the national

average, while for the most common but less specific sprains and strains, the transportation sector was highest, with construction, mining, agriculture, and wholesale

trade all higher than average. These data suggest that musculoskeletal disorders

are a problem in several industrial sectors, that is, the problems are not limited to
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the traditional heavy labor environments represented by agriculture, mining, and

manufacturing.

The National Center for Health Statistics (NCHS) survey data provide added information on self-reported health conditions of the back and the hand. This survey

presents estimates for back pain among those whose pain occurred at work (approximately 11.7 million) and for those who specifically reported that their pain was

work-related back pain (5.6 million).

The highest-risk occupations among men were construction laborers, carpenters,

and industrial truck and tractor equipment operators, and among women the highest-risk occupations were nursing aides/orderlies/attendants, licensed practical

nurses, maids, and janitor/cleaners. Other high-risk occupations were hairdressers

and automobile mechanics, often employed in small businesses or self-employed.

Among men, the highest-risk industries were lumber and building material retailing, crude petroleum and natural gas extraction, and sawmills/planing mills/millwork. Among women, the highest-risk industries were nursing and personal care facilities, beauty shops, and motor vehicle equipment manufacturing.

Questions from the NCHS survey on upper-extremity discomfort elicited information about carpal tunnel syndrome, tendinitis and related syndromes, and arthritis.

Carpal tunnel syndrome was reported by 1.87 million people; over one-third of these

were diagnosed as carpal tunnel syndrome by a health care provider and half were

believed to be work-related. Tendinitis was reported by 588,00 people, and 28 percent of these were determined to be work-related by a health care provider. Over

2 million active or recent workers were estimated to have hand/wrist arthritis. The

survey did not report these conditions by either occupation or industry.

Question. Does the literature reveal any specific guidance to prevent the development of such conditions in (a) the general population, (b) specific industries, and (c)

specific occupational groups?

Answer.

Development and Prevention in Working Populations

Because the majority of the U.S. population works, the data for the population

as a whole apply to the 80 percent who are working. There is substantial evidence

that psychosocial factors, in addition to the physical factors cited above (see response to Question 4), are significant contributors to musculoskeletal disorders. Relevant factors are repetitive, boring jobs, a high degree of perceived psychosocial

stress, and suboptimal relationships between worker and supervisor.

The weight and pattern of both the scientific evidence and the very practical quality improvement data support the conclusion that primary and secondary prevention

interventions to reduce the incidence, severity, and consequences of musculoskeletal

injuries in the workplace are effective when properly implemented. The evidence

suggests that the most effective strategies involve a combined approach that takes

into account the complex interplay between physical stressors and the policies and

procedures of industries.

The complexity of musculoskeletal disorders in the workplace requires a variety

of strategies that may involve the worker, the workforce, and management. These

strategies fall within the categories of engineering controls, administrative controls,

and worker-focused modifiers. The literature shows that no single strategy is or will

be effective for all types of industry; interventions are best tailored to the individual

situation. However, there are some program elements that consistently recur in successful programs:

1. Interventions must mediate physical stressors, largely through the application

of ergonomic principles.

2. Employee involvement is essential to successful implementation.

3. Employer commitment, demonstrated by an integrated program and supported

by best practices review, is important for success.

Although generic guidelines have been developed and successfully applied in

intervention programs, no single specific design, restriction, or practice for universal

application is supported by the existing scientific literature. Because of limitations

in the scientific literature, a comprehensive and systematic research program is

needed to further clarify and distinguish the features that make interventions effective for specific musculoskeletal disorders.

Development and Prevention in Specific Occupations

Occupations that involve repetitive lifting, e.g., warehouse work, construction, and

pipe fitting, particularly when that activity involves twisting postures, are associated with an increased risk for the complaint of low back pain and, in a few studies,

an increased risk for lumbar disc herniation.
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The prevalence of osteoarthritic changes in the lumbar spine (disc space narrowing and spinal osteophytes) is significantly greater in those whose occupations

require heavy and repetitive lifting compared with age-matched controls whose occupations are more sedentary. Despite these radiographical differences, most of the

studies show little or no difference in the prevalence of low back pain or sciatica

between those with radiological changes of osteoarthritis and those with no radiological changes. Based on the current evidence, modification of the lifting can reduce

symptoms and complaints. Specific successful strategies, which include ergonomic

interventions (such as the use of lift tables and other devices and matching the

worker’s capacity to the lifting tasks), administrative controls (such as job rotation),

and team lifting, appear successful. Despite enthusiasm for their use, there is marginal or conflicting evidence about lifting belts and educational programs in reducing low back pain in the population with heavy lifting requirements. Some examples

of positive interventions include:

Truck drivers.—Vibration exposure is thought to be the dominant cause for the

increased risk for low back pain and lumbar disc herniation. There are some data

to support the efficacy of vibrational dampening seating devices.

Hand-held tool operators.—Occupations that involve the use of hand-held tools,

particularly those with vibration, are associated with the general complaints of hand

pain, a greater risk of carpal tunnel syndrome, and some tenosynovitis. Redesign

of tools is associated with reduced risks.

Food processing.—Food processing, e.g., meat cutting, is associated with a greater

risk of shoulder and elbow complaints. Job redesign appears to reduce this risk, but

this information is largely based on best practices and case reports.

Question. What scientific questions remain unanswered, and may require further

research, to determine which occupational activities in which specific industries

cause or contribute to work-related musculoskeletal disorders?

Answer. The panel’s recommended research agenda is provided in Chapter 12 of

the report.

APPENDIX C.—PANEL RESPONSE TO DISSENT

Dr. Szabo’s dissent focuses on whether the panel was consistent in evaluating the

literature relevant to this report. His dissent deals almost exclusively with only one

of the musculoskeletal disorders considered in the report; specifically he ascribes to

the panel overstatements about the research findings relating carpal tunnel syndrome to work exposures of a variety of types.

Dr. Szabo states correctly that criteria for the inclusion of studies in the report

differed for the analysis of biomechanical exposures and for the analysis of epidemiologic associations. The four bodies of literature reviewed-tissue mechanobiology, biomechanics, epidemiology, and workplace interventions-have differing study

designs, measurement techniques, and outcome variables. The selection criteria

used in determining the quality of particular studies necessarily varied among these

literatures (see Chapter 1, pp. 22). These criteria were set early in the panel’s deliberations. Specifically, the biomechanics papers required detailed measures of biomechanical exposure, while the epidemiologic studies did not require that same kind

of detail. Similarly, the epidemiologic papers had to meet criteria for epidemiologic

inference that were not required of the biomechanics papers. The panel discussed

the distinction carefully before agreeing to adopt it. The distinction would be problematic only if the panel made epidemiologic inferences from studies included in the

biomechanics section that failed to meet criteria for epidemiologic studies. We did

not do that.

Dr. Szabo contends that the panel concluded that interventions examined in this

study prevented carpal tunnel syndrome; this misstates our report, which clearly

states otherwise (see Chapter 8, pp. 313). The report states that interventions influenced pain reports and not the occurrence of specifically defined disorders of the

upper extremities. The studies are summarized in Table 8.3. The report does not

state that interventions prevent carpal tunnel syndrome or, indeed, any other

upper-extremity disorder. The emphasis, rather, is on amelioration of symptoms,

which is the end point in the relevant literature. Furthermore, the comments on

upper extremity interventions carefully state that interventions influence symptoms,

not the incidence of specific disorders (Chapter 8, p. 313):

‘‘Studies of engineering interventions for computer-related work that reduce static

postural loads, sustained posture extremes, and rapid motions have demonstrated

decreases in upper extremity pain reports. Further study of these interventions is

needed to determine the amount of pain reduction possible, the duration of salutary

effect, and which upper extremity clinical conditions could benefit from these interventions.’’
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Dr. Szabo uses the case of carpal tunnel syndrome with regard to low-force, highrepetition exposures (primarily the use of computer keyboards) as the causal factor

to suggest that the relationship of musculoskeletal disorders to work exposure may

not be sound. The panel has recognized that the evidence for low-force, high-repetition exposures is weaker than for other relationships among risk factors and musculoskeletal outcomes; however, strong evidence for causal relationships between

physical work and musculoskeletal disorders is provided throughout the report.

The epidemiology section as it relates to the upper extremity was carefully written. We discuss the cross-sectional designs of most studies and possible implications

for causal inference, including the potential for the ‘‘healthy worker’’ effect. In 9

studies, carpal tunnel syndrome was defined by a combination of a history of symptoms and physical examination or nerve conduction testing. In these studies there

were 18 estimates of risk based on various specificities of carpal tunnel syndrome

diagnosis and varying degrees of work exposure. Of these, 12 showed significant

odds ratios greater than 2.0 (range 2.3 to 39.8), 4 showed nonsignificant odds ratios

of greater than 2.0 and 2 showed nonsignificant odds ratios of between 1.7 and 2.0.

The epidemiology section, however, does not draw specific conclusions regarding carpal tunnel syndrome. The report points out that just three articles dealt with keyboard work; indeed, keyboard work is not a major consideration or focus in the report.

Dr. Szabo’s dissent provides an incomplete view of a study published in the ‘‘Journal of the American Medical Association’’ (Atroshi, 1999). He states: ‘‘In the general

population the prevalence of Carpal Tunnel Syndrome is the same whether people

perform repetitive activities or not.’’ In the panel’s view, the nature of the design

in that study and its survey instruments were such that the power to demonstrate

this association was not high. The study, however, did show a significant risk for

carpal tunnel syndrome for blue-collar work, use of excessive force of the hands,

working with excessively flexed or extended wrist, or the use of hand-held vibratory

tools; these findings are not mentioned by Dr. Szabo.

Dr. Szabo cites the paper of Greenland and Robins (1988) to suggest that without

knowledge of cofactors which contribute to carpal tunnel syndrome, ‘‘estimates offered by Hagberg as well as the ones used in the NAS report must be interpreted

with caution.’’ In fact, the thrust of the Greenland and Robins argument is that

such attributable risk calculations may severely underestimate (not overestimate, as

implied by Dr. Szabo) the proportion of cases in which the etiologic factor is important because of possible interactions between that factor and the cofactors. Greenland and Robins cite numerous examples in which a small excess risk masks a

much larger effect of a primary study factor.

Several articles cited by Dr. Szabo in his discussion of the epidemiology literature

on carpal tunnel syndrome did not meet the quality criteria (insufficient participation and inadequate exposure measures were common problems) used by the panel

in selecting articles for the epidemiology review and so are not included in the report.

In his dissent, Dr. Szabo states, ‘‘More importantly, reliance on ergonomics to the

exclusion of medical and health risk factors can have adverse consequences for the

patient.’’ Nowhere in its report does the panel suggest the exclusive use of ergonomic interventions.

It is important to reemphasize the fact that we made a major effort to base our

conclusions on literature that met accepted scientific criteria and that the report

represents consensus of all of the panel members except for Dr. Szabo. At the same

time, the report makes plain the panel’s view that the literature about musculoskeletal disorders is incomplete, as all clinical and scientific literatures are, and also

emphasizes the importance of continuing research on a variety of fronts. There is,

however, sufficient basis in the research to date to support our conclusions and recommendations.

Jeremiah A. Barondess, Chair

Mark R. Cullen

Barbara de Lateur

Richard A. Deyo

Sue K. Donaldson

Colin G. Drury

Michael Feuerstein

Baruch Fischhoff

John W. Frymoyer

Jeffrey N. Katz

Kurt Kroenke

Jeffrey C. Lotz

Susan E. Mackinnon

William S. Marras

Robert G. Radwin

David Rempel

David Vlahov

David H. Wegman

Senator SPECTER. Thank you very much. Dr. Jane Derebery, occupational physician, Concentra Medical Services.
136

STATEMENT OF DR. JANE DEREBERY, VICE PRESIDENT OF MEDICAL

AFFAIRS, CONCENTRA MEDICAL SERVICES

Dr. DEREBERY. Thank you, Mr. Chairman. I am an occupational

medicine physician. I serve as the vice president of Medical Affairs

of Concentra Health Services which is the largest occupational

health group in the country. We treat over 500,000 injured workers

each year.

I am neither an academician nor a researcher, and had not met

Drs. Bigos, Hadler and Burton prior to this, but know them very

well through their work, which has aided me in my own practice

for many, many years. It also aids me in physician training with

my company.

In my early training in occupational medicine, of all the courses

I took I was most excited by the ergonomic courses. It made logical

sense to me that repetitive, awkward and forceful activities of my

patients could potentially cause them problems. And it also made

sense to apply the principles of ergonomics as a solution.

However, once I got into private practice, I quickly saw that

there was no consistency between the amount and type of activities

that my patients were performing and whether or not they developed musculoskeletal problems.

Those ailments that are believed to be caused by repetitive motion such as tendonitis and carpal tunnel can and do occur with no

provocation, no known cause; are also associated and even caused

by many, many medical conditions.

What in actual practice the ergonomics standards simply do not

help me with those patients. Instead, I found that dealing with external factors such as underlying medical conditions or health problems and psychosocial stressors coupled with the sports medicine

approach seemed to be more effective.

In my concern about the ergonomic standard as it was proposed,

was that it is asking me as a physician to treat my patients as if

the primary and only cause of their complaint was due to their

physical activities at work. To wrongly classify something as workrelated not only increases disability likelihood, it misdirects medical care, and it can inappropriately exclude a patient from a job.

In addition, it is an unnecessary drain to the workers’ comp system.

At my company we have the largest clinical outcome database in

the country. And that has facilitated our ability to study and improve our outcomes. In an analysis of work-related, nontraumatic

musculoskeletal disorders, we have demonstrated that the treatment strategy when it is focused predominantly on patient issues

rather than the physical job factors, that we get substantially improved outcomes.

In one regional analysis, the physicians were given training that

promoted demedicalization and early activation in patients that

had musculoskeletal problems. And in most of the cases the patients were kept at full duty during treatment.

In the treatment, the extraneous contributing health problems

and psychosocial stressors were investigated for, and when appropriate, addressed. A conditioning exercise program as well as stress

management principles generally predominated as treatment recommendations. While appropriate job problem-solving and ergo-
137

nomics suggestions were given, they were very seldom a primary

part of our treatment.

And what we found was the clinical outcomes comparing this

treatment strategy with other regional providers substantially reduced the lost time, restricted duty, disability and cost with no increase in recurrences and with high patient satisfaction.

We found similar findings with our low back pain change strategy and in which our physicians were encouraged to adhere to the

evidence-based treatment guidelines such as those of the Agency

for Health Care Policy Research in the United Kingdom.

And once again, we found with those patients the majority were

kept at full duty. And with that strategy, we had a substantial improvement over those patients who were treated the traditional

way.

The cause of musculoskeletal disorders are multifactorial involving as many psychosocial and medical and health conditions as

physical. And my concern as a physician is if we focus on the physical and the ergonomics, it may result in increased morbidity and

in disability for my patients and at great cost to industry as well.

PREPARED STATEMENT

Dr. Evanoff in the last panel mentioned the American College of

Occupational Medicine Guidelines in his endorsement of the

ergonomics standard. I am a fellow of the American College of Occupational Environmental Medicine. And for the record, we did not

come out, we did not endorse the ergonomic standards for the same

reason that I did not. Thank you.

[The statement follows:]

PREPARED STATEMENT OF DR. JANE DEREBERY

I am Dr. Jane Derebery, a board certified occupational medicine physician and the

vice president of medical operations for the Southern Region of Concentra Health

Services, the largest occupational medicine group in the United States. Each year

over five million patients are seen at our clinics, and 500,000 new patients with

work-related injuries are treated.

I am neither an academician nor a researcher, but rather a practicing clinician

within the private sector. Although I had not met Drs. Bigos, Hadler and Burton

previously, I know them through their work and publications, which have aided me

in my own practice as well as in physician training. Their work is especially appreciated, as there are widespread misinformation, half-truths, and even myths on the

subject in both medical and lay literature.

Since the advent of OSHA in 1970, work places have become safer, material handling reduced, and improved ergonomics implemented in many industries—yet low

back disability has continued to escalate, as have complaints of musculoskeletal

pain in general. This trend would support what the few high quality studies performed have demonstated: there is not evidence that ergonomic job design will prevent musculoskeletal disorders and pain.

When I first began in occupational medicine in the eighties, I found that the

ergonomics courses were the most exciting ones that I took. It made logical sense

that the more a worker was exposed to repetitive, awkward or forceful activity, the

more likely he was to incur injury. Learning and applying principles of ergonomics

seemed like the logical solution for my patients.

Once I was in actual clinical practice, however, I quickly discovered that there appeared to be little consistency regarding amount and type of activity of patients and

whether or not they developed musculoskeletal problems. The principles of

ergonomics that I had been taught didn’t seem to aid me in the real world, particularly with my more difficult patients—instead, identifying external contributors

such as underlying medical conditions and psychosocial stressors, and using a sports

medicine approach seemed to be more effective.
138

There are inherent risks in allowing politics and public policy rather than science

to decide what causes disease. Musculoskeletal aches and pains are common among

all of us regardless of our work and leisure activities. Many ailments attributed to

repetitive, forceful or awkward activity can and do occur with no identifiable provoking cause and can also be caused by systemic medical conditions. In the workers

compensation arena, physicians are being asked to treat muscloskeletal pain as if

the predominant and only cause is the physical aspect of work. Musculoskeletal disorders generally are multifactoral in origin, just as are many other medical maladies

such as heart disease or headaches. To wrongly classify a musculoskeletal illness

as work-related increases the likelihood of disability developing, misdirects medical

care, can inappropriately exclude an individual from his regular job, and places an

unnecessary drain on the workers compensation system.

Concentra has the largest clinical outcome database of any medical organization

in the country, and having outcome data has greatly facilitated our ability to study

and improve clinical outcomes. Analysis of Concentra outcome data has indicated

that when dealing with nontraumatic musculoskeletal disorders, a treatment strategy focusing predominantly on patient issues rather than physical job factors results

in substantially improved outcomes.

In one Concentra study, seven physicians in Austin were given training that promoted keeping most patients with upper extremity non-traumatic complaints at

their regular jobs during treatment, under the presumption that since the job had

caused no problems for the worker previously, it was likely that non-work factors

were predominant causes of the symptoms.

The physicians are advised to give the patient reassurance that the problem isn’t

serious, and to prescribe an appropriate program to increase strength, flexibility and

endurance. Stress reduction techniques such as regular aerobic exercise, relaxation,

etc. are also prescribed. Extraneous contributions such as underlying health problems and psychosocial stressors are investigated and when necessary addressed.

While appropriate job problem solving and ergonomic suggestions are made, these

are usually not a primary focus of the treatment.

The clinical outcomes of these providers have been followed and compared to 92

other providers in other cities in the southern region. The change in treatment

strategy have resulted in substantial, statistically significant improvements in cost

of care and disability with no reduction in patient satisfaction. Interestingly, as physicians have experienced good outcomes among their patients, they have gradually

become even more assertive in their management of patients, as evidenced by continued improvement from 1997 through 2000.

Between 1997 and 1999, the seven providers had reduced their percentage of patients on restricted duty from 74 percent to 30 percent for an average of 22 days,

as compared to the other 92 providers, who placed 82 percent on restricted duty for

26 days. In addition, in 1999, the 367 Austin patients had no lost time, compared

to a lost time rate of 3 percent in other cities. Only 6.5 percent of the Austin patients required specialty referral, compared to 21 percent by the other cities’ providers. The cost of care in Austin dropped substantially because the patients required fewer physical therapy visits and doctor visits, with the average cost in Austin being $730 per case compared to $959 per case among the other providers.

We have also had similar findings regarding low back pain by encouraging our

physicians to adhere to evidence-based low back pain treatment guidelines such as

those from the Agency for Health Care Policy and Research and from the United

Kingdom. Specifically, the guidelines encourage maintenance or resumption of normal activity, including work, in patients with low back pain. The physicians achieving the best outcomes typically and consistently place only 15–35 percent of their

back pain patients on restricted duty during the treatment course, compared to an

overall national average approaching 90 percent.

There are strong cultural beliefs and influences that play predominant roles in

shaping expectations about the ability of repetitive physical activity to cause musculoskeletal disorders. This has rendered us susceptible to the misinformation and

myths being widely published not only in the lay literature but even in the medical

literature.

For example, there is no scientific evidence to support that carpal tunnel syndrome can be caused or aggravated by prolonged keyboard use; yet I have repeatedly seen that reported as fact in such widely read periodicals as TIME, Newsweek,

and the New York Times. Two years ago, when a hand surgeon from Columbia University testified as an expert witness in a products liability class action suit against

a keyboard manufacturer, he rendered his medical opinion that keyboarding caused

the claimants’ carpal tunnel syndrome. When pressed to cite what scientific article

he had read to justify his opinion, he finally stated that he had read it in TIME

magazine! In actuality in the almost fifty cases of products liability suits against
139

keyboard manufacturers not one claimant has ever been awarded a cent, so strong

is the scientific evidence that use of a keyboard does not cause carpal tunnel syndrome. Yet, the myth that it does prevails in our society—with profound influence.

The cause of the current spate of CTD disorders is multifactoral, involving as

many psychosocial and medical factors as job-related ones. To focus exclusively on

the physical and ergonomic aspects of the problem may result in increased morbidity and disability at great cost to the patient and to society. Addressing the problem as it is perceived by the patient or the public, contributes to the problem rather

than to its resolution.

Senator SPECTER. Thank you very much, Dr. Derebery. We now

turn to Dr. Laura Punnett.

STATEMENT OF DR. LAURA PUNNETT, PROFESSOR, DEPARTMENT

OF WORK ENVIRONMENT, UNIVERSITY OF MASSACHUSETTS

LOWELL

Dr. PUNNETT. Thank you very much, Senator. I think perhaps

there are a few things that almost everyone in this room could

agree upon. One is that some musculoskeletal disorders are not

work-related. Some I think the rest we may be in disagreement

about, but certainly there is an important amount of morbidity

which arises in relation to non-occupational factors is really not in

dispute by anyone.

Another important point is that some amount of physical activity

is essential to maintaining good health. And the key question then

for us is how much activity or effort or motion is too much. And

I would add what kind and under what conditions.

People who are employed full-time spend——

Senator SPECTER. So where there is agreement is that some ailments are not related to work and some exercise is good?

Dr. PUNNETT. Yes, Senator.

Senator SPECTER. And that is where you stop your testimony on

the area of agreement?

Dr. PUNNETT. Correct. I am not sure I am going to be able to

offer you much more——

Senator SPECTER. That is not a whole lot of agreement, Dr.

Punnett, but it is not inaccurate from what I have heard. Go

ahead.

Dr. PUNNETT. I am trying to help you find some consensus.

Senator SPECTER. Trying to help me find what?

Dr. PUNNETT. Some consensus.

Senator SPECTER. I would not call it consensus to say that it is

11:15, which is about what you have said. Go ahead.

Dr. PUNNETT. People who are employed full-time spend more

waking hours at our jobs than anywhere else. But I think of equal

importance to the hours we spend at work is that while we are at

work we do not have the same freedom to choose how we spend our

time as we do for example when we are gardening or playing tennis.

A stenographer in a courtroom has to keep up with an expert

witness who is giving testimony. A mail carrier has to complete a

route and return to the post office within a specified period of time.

A nurse’s aid has to move a disabled patient from the wheelchair

to the commode when the patient’s needs dictate, even if there is

no one else nearby to help.

So the way the work is organized, the tasks designated to each

individual, the equipment or tools provided determine both the
140

physical load, how fast you are working, how hard, what body postures are necessary, as well as what we call the psychosocial factors, meaning psychological demands such as time pressure, opportunity to decide what to do when, factors that are generally under

the employer’s control as well as the physical load factors are.

These psychosocial factors are established to be associated with

the subjective experience of stress. They are related to risks of

some diseases such as cardiovascular disorders.

The scientific literature on their effect on musculoskeletal disorders is quite more recent and still very limited, while in contrast

the literature on physical factors is voluminous.

And we have already heard from the NAS that there are literally

hundreds of studies with a variety of study designs and methods,

different samples of the population conducted in many different

countries all showing risk of musculoskeletal disorders to be proportionate to the level of exposure to physical load.

These kinds of exposure response examples are numerous. Just

two very quick examples, a German study showing that new back

pain among male construction workers was associated with the

amount of handling of concrete blocks and other heavy paving

items, and a British study of nurses showing that the incidence of

new back pain was proportionate to the number of patients handled per day.

So the literature is voluminous. There have been dozens of reviews of this literature as well. Like both of the NAS reports, virtually all of the reviews, not all but the vast majority, agree that

some studies are better than others, that not every question has

been answered yet but that there is a very substantial evidence

showing the relationship of physical workload to musculoskeletal

disorders.

The better studies include a variety of, meet a variety of scientific and methodologic criteria including the fact that they address the role of non-occupational factors. If someone has a history

of a wrist injury or goes bowling every Thursday night or has been

diagnosed with diabetes, we have statistical methods of removing

the influence of these individual factors and making sure that or

evaluating whether the association is still there when they are

taken out of the picture.

If we limit ourselves to the cream of the crop, the few dozen studies rather than the few hundred which are most rigorous, we still

have at least ten times as many studies as OSHA had to rely on

in rule making on benzine for example or setting a permissible exposure limit for lead in air or rule making on formaldehyde.

PREPARED STATEMENT

Of course not every question has been answered, but again

standards have been passed without every ‘‘I’’ being dotted and

every ‘‘T’’ crossed. We had no animal model for asbestos or for benzine effects at the time that those OSHA standards were passed.

And I respectfully submit that while we need more research, we

also have ample evidence in hand now to begin to prevent the

many unnecessary disorders that are occurring.

[The statement follows:]
141

PREPARED STATEMENT OF DR. LAURA PUNNETT

Qualifications and experience

I am an occupational epidemiologist and ergonomist with a Doctor of Science degree in epidemiology and occupational health and safety from the Harvard School

of Public Health and two years of specialized post-doctoral training in occupational

ergonomics at the Center for Ergonomics, The University of Michigan (Ann Arbor).

I am a founding faculty member of the Department of Work Environment at the

University of Massachusetts Lowell (UML), where I now hold the rank of Professor.

The Department combines a traditional occupational health and safety approach to

the identification of workplace hazards with a more innovative focus on the development and evaluation of engineering control measures for those hazards. I am also

Co-Director of the Lorin Kerr Ergonomics Institute for Occupational Injury Prevention at UML. The Institute conducts research and provides technical assistance

throughout the region on the health, safety, and productivity consequences of the

failure to design jobs to fit human needs. We take a multi-disciplinary approach to

the study of work-related musculoskeletal disorders, injuries and psychosocial

stress, their impact on employers, workers, and society, and their prevention

through changes in work organization and equipment.

My primary research areas are the epidemiology of work-related musculoskeletal

disorders; the effect of ergonomic stressors on other health endpoints, such as pregnancy outcomes and acute injury; and methods for workplace measurement of ergonomic exposures, including the validity of worker self-assessments. Since 1981, I

have investigated these issues in a wide variety of manufacturing and service occupations, including the automobile industry, garment assembly and other light manufacturing, clerical work, retail food stores, hospitals, small farms, sawmills and wood

products processing, and highway construction. I have also studied the factors influencing the effectiveness of ergonomic intervention programs and joint labor-management health and safety committees in industry. I am the author or co-author of

about 40 articles in peer-reviewed scientific journals, as well as numerous book

chapters, technical reports, and papers and abstracts in peer-reviewed conference

proceedings. My research has been funded by the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control Center on Injury

Prevention, the UAW-Chrysler Joint National Committee on Health and Safety, the

March of Dimes, and the Massachusetts Centers of Excellence Corporation.

Since 1993 I have been a Visiting Lecturer in Occupational Health at the Harvard

School of Public Health, in Boston. I am a member of the Research Committee on

Musculoskeletal Disorders of the International Commission on Occupational Health.

In 1996, I was in residence as a Visiting Scientist in the Division of Ergonomics,

National Institute of Working Life, Sweden; since that time I have had continuing

collaborations with several researchers at the Institute and have returned for several working visits. I have served by invitation on the NIOSH Mine Health Research Advisory Committee (U.S. DHHS), two NIOSH research review panels, and

advisory boards for the Massachusetts Department of Public Health Occupational

Disease Surveillance (SENSOR) Project, the Center for VDT and Health Research,

Johns Hopkins School of Hygiene and Public Health, the Occupational and Industrial Orthopedics Center (Hospital for Joint Diseases, New York NY), and the

Ergonomics Technology Center of the University of Connecticut (Farmington CT). I

have consulted on environmental and occupational epidemiology to the World

Health Organization. I serve on the Editorial Boards of the peer-reviewed journals,

Applied Ergonomics, New Solutions: A Journal of Environmental and Occupational

Health Policy, and Salud de los Trabajadores (‘‘Workers’ Health,’’ published in Venezuela). I have served as a peer reviewer to 12 scientific journals and several private

and public research funding agencies.

Both as an individual consultant and through the Kerr Ergonomics Institute, I

have conducted training programs in occupational ergonomics for engineers, supervisors, medical and safety personnel, and labor representatives in a wide variety of

workplaces. Consulting clients have included General Motors, Ford Motor Company,

Digital Equipment Corporation, General Electric, Millipore, Herman Miller, Jim

Walters Paper, CBS/Fox Video, and the U.S. Army Environmental Hygiene Agency.

I have lectured internationally on occupational health, ergonomics and epidemiology

and presented seminars and professional short courses for professional associations

(e.g., American Industrial Hygiene Association, American Society of Safety Engineers, Nordic Institute for Advanced Training in Occupational Health and Safety,

International Commission on Occupational Health, Israeli Ergonomics Society) as

well as at institutions of higher education in the United States, Canada, The Netherlands, Spain, Chile, and Sweden.
142

In 1998, I was invited to participate on the panel that reviewed the epidemiologic

evidence on work-related musculoskeletal disorders for the National Academy of

Sciences (National Research Council), in response to a mandate from the U.S. Congress. In 1999, I was a member of the committee that drafted the new Threshold

Limit Values (TLVsR) on Hand Activity Level of the American Conference of Governmental Industrial Hygienists—a set of quantitative exposure limits intended to

aid in preventing or reducing the occurrence of upper extremity musculoskeletal disorders.

Issues addressed in this testimony

This testimony primarily addresses the epidemiologic literature on work-related

MSDs, including the basis for concluding that there is a causal relationship with

occupational physical ergonomic stressors and that reductions in harm to workers

can be anticipated by reductions in exposure to these stressors. Exposure-response

relationships have repeatedly been demonstrated, and the evidence is at least qualitatively consistent across sectors of the economy and around the world, wherever

the problem has come to light. There are unresolved questions regarding the nature

and role of psychosocial factors and more research is needed to clarify diagnostic dilemmas and to elucidate pathomechanisms. There is striking evidence that MSDs

are greatly under-reported in many workplaces and that therefore, however high the

frequency and costs of MSDs may seem, the true magnitude is undoubtedly greater

than statistics show. Although formal intervention studies are difficult to conduct

successfully, there is substantial experience of the feasibility and benefits of workplace ergonomics interventions (training and engineering controls) implemented by

employers.

Scientific evidence regarding physical exposures and the occurrence of MSDs

There is an extensive scientific literature documenting that physical job features

can cause musculoskeletal disorders. These hazards can occur in a multitude of

forms, depending on the specific nature of the work; the characterization of

ergonomics exposures thus often depends on the sector of employment and even the

specific occupation. Nevertheless, a common set of occupational exposures has been

associated generically with adverse musculoskeletal health effects.

The scientific evidence for the work-related occurrence of musculoskeletal disorders among occupationally exposed individuals includes both epidemiologic studies

and basic science (biomechanical and patho-physiological laboratory experiments).

The combination of the two is important because together they demonstrate the biological plausibility of the epidemiology and the coherence and complementarity of

the findings. For example, tendon strain and cell damage have been shown to occur

experimentally as a function of work pace (the frequency and duration of mechanical

loading), the level of muscular effort, and recovery time between exertions.

The basic science pertaining to mechanisms by which physical load, in its various

forms, can damage soft tissues was reviewed by Rempel et al., Ashton-Miller, and

Radwin and Lavender for the National Academy of Sciences (NAS) in 1998 (1), as

well as by others (e.g., 2–7). The preamble to the OSHA Ergonomics Standard (Section V., ‘‘Health Effects’’) also summarized the literature, illustrating how repeated

or forceful efforts, sustained static loading, anatomically non-neutral postures, accelerated movements, externally applied compressive forces, and vibration are understood to affect musculoskeletal, nerve, and circulatory tissues.

NIOSH REVIEW OF MSD EPIDEMIOLOGY IN 1997

The authoritative review of the epidemiology in this field is that published by the

National Institute for Occupational Safety and Health (NIOSH) in 1997 (8). This literature review was conducted according to standard, accepted epidemiologic principles and gave greatest weight to studies in which the results could be shown to

be relatively unaffected by selection bias or information bias. Almost all of the studies considered in the review had been published in peer-reviewed scientific journals,

meaning that they already had been through the standard quality control process

and found to be scientifically valid prior to their publication. The review document

itself was evaluated prior to publication by 27 scientists with research, teaching,

and consulting expertise in the field of occupational ergonomics.

The NIOSH review concluded that there is ‘‘a consistent relationship between

MSDs and certain physical factors, especially at higher exposure levels.’’ Although

some specific exposure-response relationships have not been demonstrated and more

research is needed in several areas, there is evidence that exposure to each of these

ergonomic factors causes MSDs in one or more body regions: repetitive upper extremity motion patterns; forceful exertions, whether manual only or whole-body

(e.g., heavy lifting); non-neutral body postures; and vibration. The risk is especially
143

pronounced when a job includes exposure to a combination of two or more of these

risk factors.

The odds of finding so many positive studies, using so many variations on study

design and methods, in so many countries, would be extremely small if ergonomic

exposures were not truly hazardous to the musculoskeletal system. Even were we

to restrict ourselves to the 13 investigations that were the most rigorous and convincing, these would represent a larger body of evidence than has been used for

OSHA rule-making on many other workplace hazards.

These strongest studies also demonstrate that physical job factors cause MSDs

independently of any other factors, such as medical history, age, or psychosocial

strain, that might also be associated with MSDs in the general population. In other

words, while MSDs have a background rate in the general population that is above

zero, there is a marked additional increase among people whose jobs expose them

to excessive physical demands.

EPIDEMIOLOGIC EVIDENCE SINCE 1997

In addition to those studies relied upon by NIOSH in the 1997 review, other investigations are continuously being carried out. The studies published since 1997

are too numerous to catalogue them all here; some notable examples have been selected to highlight the ever-expanding knowledge base. These are chosen, in particular, to fill in gaps that NIOSH identified with regard to particular exposure-response combinations, and to illustrate how newer studies, many of them longitudinal, are adding to the evidence confirming earlier conclusions that were based primarily on cross-sectional studies. Longitudinal investigations are particularly important because they are less ambiguous with regard to cause preceding effect than

other study designs, so the resulting evidence is inherently stronger. In addition,

they can provide evidence regarding the progression (‘‘natural history’’) of MSDs, the

latency period from exposure to effect, and the factors affecting prognosis or outcomes after MSD onset.

For example, the NIOSH review concluded that there was ‘‘evidence,’’ but not

‘‘strong evidence,’’ that postural stress and repetitive work cause shoulder disorders,

and ‘‘insufficient evidence’’ to draw conclusions about the effects of forceful work or

vibration on the shoulder. More recently, at least two new studies have provided

new evidence regarding the effects of these exposures on the shoulder. Frost and

Andersen (9) followed a closed cohort of 1,591 workers from a slaughterhouse and

a chemical factory over a seven-year period. The slaughtering and meat processing

tasks were videotaped and analyzed in detail and shown to involve pronounced postural stress, with the upper arms elevated to an included angle of 30 degrees or

more for about one-half of the work day. Shoulder impingement syndrome, defined

as a combination of shoulder symptoms lasting at least 3 months within the past

year plus a positive sign of impingement on clinical examination, was more common

among slaughterhouse workers than among the chemical workers. The risk increased with number of years of exposure to meat processing work and was particularly high among former slaughterhouse workers. The age-adjusted prevalence ratio

showed a steep slope in the first 5 to 6 years of exposure and then another steep

increase after about 25 years of cumulative exposure, providing evidence that risk

increases with duration of exposure to postural stress and heavy work, even after

many years of employment.

My colleagues and I conducted a case-control study of shoulder disorders reported

to the in-house medical department of an automobile assembly plant (10). All cases

and a random sample of non-case workers from the same production departments

were evaluated by interview and physical examination. Shoulder disorders (on combination of medical report and interview) were associated with severe flexion/abduction (above 90 degrees) of the shoulder. The risk of incurring a shoulder MSD increased with the proportion of the work cycle that workers were exposed to severe

flexion/abduction. The exposure-response relationships were similar for cases with

and without physical findings. Forces exerted through the shoulder did not confound

these results; peak torques at the shoulder were rather low for all workers. Use of

hand-held tools further increased the risk and also interacted with postural stress.

Relevant evidence regarding the effect of ergonomic exposures on the neck is also

found in a report on persistent neck disorders associated with use of a now obsolete

grinding machine in a Swedish steelworks (11). Use of this machine had ‘‘caused

heavy static load to the arms, shoulders, and neck, vigorous impacts and vibrational

forces being transmitted upwards via the out-stretched arms.’’ The authors located

the last 15 workers who had performed this work, all of whom had left the occupation 11–29 years earlier because of continuous neck-shoulder pain, and 6 of whom

were on total disability pension. Even after so many years, all still had persistent
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neck pain, stiffness, reduced range of motion, joint degeneration, widespread numbness and tingling and reduced sensation.

A number of new studies have addressed the effects of repetitive manual work

on upper extremity disorders (12–15). Nordander et al. (16) examined a set of fish

processing jobs that were all highly repetitive, with fast, restricted movements and

only light lifting demands. Compared with people with more varied jobs, the fish

processing workers had triple the risk of neck/shoulder and elbow/hand diagnoses

by physical examination. There were 5 cases each of wrist tendonitis and carpal tunnel syndrome (CTS) among the fish processing workers, compared with 0 and 1, respectively, in the other workers. Work processes changes in another fish processing

plant increased the repetitiveness and stereotypy of the physical motion patterns,

which led to increased risk of elbow, wrist and finger symptoms (17). In a study of

CTS patients and prognosis after medical treatment, the performance of hand-intensive work prior to onset was associated with less complete relief of CTS symptoms

after surgery, which in turn predicted failure to return to work due to CTS (18).

Thus, NIOSH’s findings of ‘‘evidence,’’ but not ‘‘strong evidence,’’ that repetitive and

forceful work cause CTS can also be updated from these more recent findings.

A series of papers by Nathan and colleagues on median nerve neuropathy (MNN),

an indicator of CTS, has purported to show that the only ‘‘important’’ causes are

individual, non-occupational factors such as age and obesity (e.g., 19–22). This ongoing cohort study suffers from a number of serious methodologic flaws, as noted

by NIOSH (see summary in Table 5a–5 of (8)) and others (23). However, it should

also be noted that the authors’ ranking scheme for physical work demands (repetition and force) was cross-sectionally associated with MNN (19) and predicted the 5-

year incidence of slowed nerve function (20). Other reviewers of this paper have concurred in finding these data to show a positive association (24). The question as

posed by Nathan and colleagues, whether occupational or non-occupational causes

of CTS are ‘‘more important,’’ is misleading (and is not appropriately answered by

statistical testing such as p-values). Rather, the appropriate policy question is

whether, among persons exposed to ergonomic stressors at work, an important proportion of CTS (and other disorders) could be prevented by workplace improvements.

The data published by Nathan et al., in fact, support rather than argue against this

conclusion.

With regard to back disorders, the NIOSH document also concluded that there

was evidence, but not strong evidence, regarding the effect of ‘‘heavy physical work’’

on back disorders. Since then, a German research group published a three-year prospective study of 571 male construction workers, who participated in ‘‘comprehensive interview and physical examination surveys’’ at baseline and again at followup (25). The proportion of the population followed up was 86 percent, and only exposure information shown to be reproducible was used in the analyses. After adjustment for age, height, and body mass index, the risk of new low back pain was increased among workers whose work tasks included scaffolding, sawing, erecting roof

structures and laying large sandstones. After further adjustment for trade, to account for tasks performed only by carpenters or bricklayers, for example, additional

exposure-response relationships were found for two different indices of cumulative

exposure to handling heavy stones or concrete blocks.

A prospective investigation of nurses in Great Britain (26) was remarkable for the

intensity of its follow-up procedures; the nurses were asked to complete a standardized questionnaire every 3 months for a two-year period. Among those who had been

free from low back pain for at least one month at baseline, the risk of new pain

was predicted by the frequency of manual transfer of nurses’ patients under various

conditions. The authors noted, as have others previously, the additional effect of

prior back pain, which in itself may be a marker for prior occupational loading on

the back. Another recent study of heavy work and back disorders involved a fiveyear follow-up of a random sample from the general population in Finland (27), in

which the outcome was defined as moderate or severe back pain with functional impairment. The study concluded that, ‘‘heavy occupational musculoskeletal loading

and high general occupational physical demands predicted future back pain.’’ A sixyear follow-up of dock workers showed that very heavy work was associated with

a higher rate of increase in musculoskeletal disorders on examination of the back,

neck, shoulders, hands and feet (28).

Other cohort studies have examined the risk of disorders in the musculoskeletal

system overall. A Dutch study reported increased frequency of musculoskeletal

symptoms among male employees who performed heavy physically demanding work,

especially in the young and middle-aged subjects (29). Long-term disability, especially that due to musculoskeletal disorders, was predicted by the number of years

worked in piece-rate garment manufacturing in Canada (30). In a sample of the

French population after retirement, the cumulative incidence of disorders of the
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back, upper or lower limb joints was higher among those who had performed heavy

physical work for longer than ten years (31). Another recent study of my own found

a strong cross-sectional relationship between upper extremity disorders and combined ergonomic exposures, with the same exposure index prospectively predicting

both the incidence of new disorders after one year and the persistence of upper extremity problems from baseline (32, 33).

OTHER LITERATURE REVIEWS

Other epidemiologic reviews of workplace exposures and MSDs, by experts in various countries, have been published in the peer-reviewed scientific literature. Although they have varied somewhat in their inclusion and exclusion criteria and review procedures, the majority of these reviews have drawn similar conclusions regarding the causal importance of repetitive motion, forceful manual exertions, nonneutral postures, and segmental vibration for upper extremity disorders and of

heavy lifting, non-neutral trunk postures and whole-body vibration for disorders of

the back and lower limbs (2, 24, 34–60).

NIOSH’s review and basis for these conclusions was itself subsequently endorsed,

both methodologically and substantively, by the National Academy of Sciences in

1998. The first NAS study was publicly discussed by about 75 scientists and other

workshop participants, the overwhelming majority of whom agreed that ‘‘There is

a higher incidence of . . . injury . . . and disability among individuals who are employed in occupations where there is a high level of exposure to physical loading

than for those employed in occupations with lower levels of exposure’’ (page 23 in

(1)). (The second NAS study is not described here because it will be discussed separately at this hearing.)

In 1997, the Swedish National Institute of Working Life (NIWL) commissioned a

review of the epidemiologic literature specifically limited to occupational use of video

display units (VDU) and upper extremity musculoskeletal disorders. This review

covered 72 reports from 56 different epidemiologic studies, primarily peer-reviewed

scientific journal articles (61). The NIWL endorsed the conclusion that use of a VDU

was a direct causative agent of hand and wrist disorders, mediated primarily

through repetitive finger motion and sustained muscle loading across the forearm

and wrist. The risk was particularly pronounced for those in more keyboard-intensive jobs, such as data entry, which are more stereotyped and involve more continuous exposure with fewer alternative tasks or rest breaks.

In 1999, Dr. Barbara Silverstein and I re-considered the epidemiologic literature

on work-related MSDs, at the request of the American Conference of Governmental

Industrial Hygienists (ACGIH), in order to assess the nature of the guidance that

could be obtained as a basis for establishing one or more Threshold Limit Values

(TLV) for occupational exposure to physical ergonomic stressors (62). From the most

rigorous epidemiologic studies, we extracted data on dose-response relationships and

on exposure levels at which there was a significant increase in risk of upper extremity MSDs and which could be operationalized in the form of a TLV; for example,

there was quantitative evidence to justify a TLV of 1–2 hours per day of exposure

to repetitive wrist bending or twisting, 1 hour per day of highly forceful manual

work, and 1 hour per day of shoulder flexion or abduction (work with the arm above

shoulder height). Four different studies showed an increased risk of shoulder disorders when such postural stress is experienced for only 1 to 2 hours per day (see

Table 6). We also confirmed the findings of Bernard et al. (8) that exposure to multiple ergonomic risk factors in the same job has at least an additive effect, if not

much greater, and recommended that a TLV for any one dimension of physical load

should take account of whether other forms of exposure are also present in the job.

A new report by the European Agency for Safety and Health at Work (63), an office

of the European Union, has concluded that, ‘‘The scientific reports, using defined criteria for causality, established a strong positive relationship between the occurrence

of some WRULDs [work-related neck and upper limb musculoskeletal disorders] and

the performance of work, especially where workers were highly exposed to workplace risk factors.’’ The risk factors identified as particularly requiring preventive

reductions by the European Agency were a familiar list: non-neutral postures of the

shoulder and wrist, force applications at the hand, hand-arm exposure to vibration,

direct mechanical pressure on body tissues, cold, and work organization factors.

EXPOSURE-RESPONSE RELATIONSHIPS

A large number of investigations have demonstrated exposure-response relationships between physical ergonomic exposures and the risk of MSDs, and a number

of reviewers have cited this evidence in concluding that there were causal relationships (e.g., 2, 8, 41, 43, 58, 64). An exposure-response relationship means, in general
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terms, that as the amount (intensity, frequency or duration) of a risk factor increases, so does the probability, or risk, of an adverse health effect. An exposureresponse relationship, when present, is considered to strengthen the evidence of a

causal relationship because it is believed to be a characteristic of cause-effect situations, in general, absent evidence to the contrary. In addition, it is thought that it

would be more difficult for many or most forms of bias or confounding to produce

an artifactual exposure-response relationship than to bias a simple association such

as an odds ratio.

Some have argued that the lack of comprehensive exposure-response data represents a level of scientific ignorance that prohibits any preventive action. However,

it is not a sine qua non, in that an epidemiologic study can provide valuable information even if both exposure and outcome are dichotomous. Furthermore, the lack

of an exposure-response relationship is not necessarily evidence against a causal effect, since not all pathomechanisms would produce such trends.

More importantly, there is substantial evidence of interactions among physical exposures, so that (for example) jobs requiring both repetitive and forceful motions

have a higher risk than jobs requiring either exposure alone (65–67). The multifactorial nature of these relationships must be taken into account in interpreting research findings. A ‘‘low’’ level of muscular exertion would seem to be safer than a

‘‘high’’ level of force, everything else being equal; but if the low force must be sustained for an excessive period of time, then the prolonged duration of the exertion

may render it as hazardous as a brief but more strenuous exertion (6). Thus, the

exposure-response curve for each exposure should ideally be described as a function

of the level of each other exposure that might also be present in the same job. There

are obviously an enormous number of possible exposure combinations, and not all

have yet been rigorously studied by epidemiologic methods.

Two misconceptions that have arisen during debate on this literature are that (1)

if an exposure-response relationship existed, it would necessarily be linear or

monotonic; and (2) that it would necessarily indicate an exposure level that could

be used to differentiate between background risk of MSDs and an occupationally elevated risk. First, an exposure-response relationship need not take the form of a

straight line through all data points; it may conceivably be better described as a logistic curve, or as a step-function, or as any other of a variety of mathematical functions. As only one example, the analyses described above by Frost et al. (9) clearly

showed a non-linear exposure-response trend with cumulative exposure to repetitive

and loaded shoulder flexion. A non-linear relationship specifically accommodates the

likelihood that some physical activity is beneficial and that only at more extreme

levels do adverse health effects occur, another point advanced in supposed disagreement with the evidence summarized here.

Secondly, an exposure-response trend does not necessarily indicate a single exposure level that unambiguously differentiates risk from no risk. On the contrary, a

perfectly linear relationship would by definition not provide a clear threshold level.

This is especially true if exposure is treated as continuous and the relationship fits

a straight line through the origin, in which case each small increment in exposure

increases the probability of an adverse health outcome and, extrapolated downward,

there may be no discernable point without excess risk above the zero exposure level.

When epidemiologic data indicate a good fit with a continuous exposure-response

relationship (rather than a step function, for example), the designation of a permissible exposure level is a policy decision rather than a judgment following inevitably

from the scientific data. Several authors have called attention to the complexity of

this process of utilizing exposure-response data for quantitative risk assessment in

the multi-dimensional domain of physical ergonomics (e.g., 2, 58, 64, 68, 69). It is

reasonable to conclude, as these experts have done, that there is a need for continuing study of those relationships and interactions, and at the same time that it

is appropriate to implement the scientific knowledge in hand in order to prevent at

least part of the work-related morbidity that is presently occurring within the American workforce.

PSYCHOSOCIAL FACTORS AND MSDS

Another type of stressor that has received increasing interest with respect to

MSDs is that of psychosocial factors. The term ‘‘psychosocial’’ is used in a variety

of ways by different authors, which has led to tremendous confusion both in the scientific literature and in public discussion. It is critical to distinguish between psychological attributes of individuals—such as personality, coping skills, motivation or

mood states—and the strain imposed on individuals by features of their work environment resulting from the organization of production activities. Work organization

factors—task structure, the division of labor, and skill utilization—are partial deter-
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minants of physical load as well as of psychological job content and constraints that

may cause workers to experience ‘‘stress.’’

According to one widely used, internationally standardized measurement approach (Job Content Questionnaire), there are three key measures of psychosocial

job characteristics: psychological job demands, decision latitude, and social support

(70–72). Decision latitude is based on the worker’s decision authority and the worker’s discretion over skill use, i.e., the worker’s ability to control his/her own work

process and to decide which skills to utilize to accomplish the job. Psychological job

demands reflect both physical pace of work and mental work load, especially time

pressure in processing or responding to information. In this model, high psychological job demands in combination with low decision latitude result in residual job

strain and, over time, chronic adverse health effects such as cardiovascular disease.

Clearly, these psychosocial features of the work environment are under the control of the employer just as much as are physical factors such as work pace and tool

attributes. In fact, there is a recognized overlap between some physical and psychosocial exposures; the experience of performing a repetitive, monotonous task on a

machine-paced assembly line can be described equally well in terms of stereotyped,

repetitive motion patterns with rigid pacing and few rest breaks, and as ‘‘poor’’ psychological job content, with few opportunities to make decisions, work collaboratively with coworkers, utilize existing skills or learn new ones. The relationship

of work organization factors with psychosocial strain has also been demonstrated by

intervention studies showing that increasing worker participation in decision-making can resolve physiological strain linked to high levels of demands over which the

worker had no control (72).

The occupational psychosocial stressor most consistently associated to date with

musculoskeletal disorders is lack of decision latitude or autonomy (73). However, the

evidence regarding a causal relationship with MSDs is still quite limited, and several reviews have concluded that the epidemiologic evidence is relatively weak. On

the other hand, the known physiological effects of psychosocial strain at work include several plausible mechanisms by which the musculoskeletal system could also

be affected: adverse circulatory patterns; high levels of sympathetic nervous symptom arousal with general central nervous system consequences as well as endocrine

system impacts on circulating hormones; tonic activation or ‘‘psychogenic’’ muscular

tension; and interference with normal muscle and tendon repair processes (e.g., 74–

79). These postulated mechanisms deserve further study, but in the meantime the

literature on these associations should not be regarded less critically than the literature on physical risk factors.

SUMMARY OF THE EPIDEMIOLOGY

In summary, the epidemiologic evidence linking physical ergonomic exposures at

work with risk of MSDs is extensive, biologically plausible, and methodologically

adequate to inform primary prevention. Numerous reviewers have concluded that

ergonomic exposures such as repetitive work, heavy lifting, forceful manual exertions, vibration, and postural stress are causally related to the occurrence of musculoskeletal disorders affecting neck, shoulder, hand/wrist, and back. New research

has strengthened the evidence supporting these conclusions. There is substantial

evidence of increasing risk with increasing exposure, and of interactions among

physical exposures. These relationships have been found in studies of specific workplaces as well as in samples of the general population. The available longitudinal

evidence generally confirms, in general terms, the conclusions previously drawn

from cross-sectional studies regarding the etiologic association between working conditions and UE MSDs. The impact of physical exposures at work cannot be explained away by demographics (e.g., age or gender), medical history, or other attributes of individuals.

There is an international near-consensus that effective prevention of these disorders necessarily involves, among other measures, reduction of workplace exposure

to ergonomic risk factors, and several eminent scientific reviewers have specifically

called for regulatory action, even given imperfect epidemiology and understanding

of pathomechanisms to date (e.g., 57, 69). Research agencies of the European Union

have endorsed ergonomics standards and presumptive rules for identifying work-related MSD cases (63, 80). Among the U.S. organizations reaching similar conclusions are NIOSH (1997), the National Academy of Sciences (1998, 2001), and

ACGIH (1999).

Costs of work-related MSDs

In addition to the human pain and suffering associated with MSDs, other losses

are externalized to workers, with adverse financial and psychosocial impacts. There

are also costs to employers through workers’ compensation claims, scrap and de-
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creased production quality, medical insurance premiums, labor turnover, and adverse impacts on labor relations, although many of these are not linked by traditional accounting methods to ergonomic problems per se. The proportion of these injuries and illnesses that are work-related are by definition preventable, as are their

costs to employers, to workers, and to society. Several have estimated that the real

costs to employers, including ‘‘indirect’’ or ‘‘hidden’’ costs, of workplace injuries and

MSDs can range from 2 to 3.5 times the amount paid in workers’ compensation

cases (81–84).

However, it cannot be assumed that market-driven cost-benefit calculations will

be sufficient to motivate worker protection, because firms typically emphasize shortterm costs over long-term and because a large proportion of these costs are not identified by traditional accounting methods as due to ergonomic problems in the work

process (82). Furthermore, fundamental work organization features are rarely questioned; on the contrary, modifications to increase productivity and profitability, such

as just-in-time systems, lean production and total quality management or continuous improvement, appear to have intensified job demands for workers (85).

Workers experience other financial losses—some covered by compensation and

others not—including the cost of medical care and lost work time, lost future earnings and fringe benefits, reduced job security and career advancement, lost home

production and child care, and home care costs provided by family members (81, 86).

Non-monetary losses include pain and suffering, family relations, sense of self-worth

and identity, social and community relationships, and recreational activities (84,

87). These costs may accrue for many years, because of the long duration of many

MSDs; the 5-year rate of increase in joint pain after retirement was higher among

French subjects who had held jobs with heavy physical work load (31). More generally, disability retirement is disproportionately likely when people work in

ergonomically stressful jobs such as heavy physical labor or repetitive tasks (30, 88).

Underreporting of MSDs in the workplace

The magnitude of MSD under-reporting through administrative data bases has

been noted repeatedly. For example, in one automobile assembly plant, more than

one-half of workers selected at random had unreported back or shoulder disorders

on interview or examination (10, 89). However, only about 20 percent of workers

with a serious episode of musculoskeletal pain appear to have sought in-plant medical attention (83). Less than one percent of medical visits for MSDs were flagged

as workers’ compensation cases, although 17 percent had work restrictions, almost

8 percent resulted in lost work time, and 5 percent required outside medical treatment. Many workers reported seeking medical care from outside providers.

Others have also shown that the frequency (and therefore the cost) of work-related MSDs is severely underestimated, by as much as 60 percent, when relying on

traditional administrative data sources such as workers’ compensation records and

OSHA logs of recordable injury and illness (90, 91). Even among unionized auto

manufacturing employees, who should perceive higher job security than many other

workers, only 25 percent of those with work-related MSDs filed a compensation

claim or applied for benefits (92). The reasons for under-reporting by employers and

by workers likely include failure to recognize work-relatedness; concern about job

security; workplace incentives for supervisors to discourage reporting; employee

preference to avoid the workers’ compensation system and obtain medical care coverage through private insurance, anticipated rejection of the claim, and even denial

of the injury itself because of financial need or a sense of self-worth contingent on

providing for oneself and one’s family (92–98).

Under-estimation of MSD frequency also results from injured workers leaving the

workplace, i.e., the ‘‘healthy worker effect,’’ also referred to as a survivor or selection

bias. Not surprisingly, workers who develop musculoskeletal disorders in

ergonomically stressful jobs are disproportionately more likely to transfer to less exposed positions or to leave the workplace altogether (18, 99–103). In the automobile

assembly plant studies cited above (10, 89), almost 75 percent of both the back and

shoulder cases reported difficulty in doing their current or past jobs, and about onethird had voluntarily transferred out of previous job assignments because of pain

and impaired performance.

The significance of this survivor effect is that it artificially reduces the risk measures that can be determined from the population, because the most exposed and affected individuals are missing from the data set. Such a bias masks evidence of exposure-response relationships, meaning that positive associations found in these

studies would likely have been even stronger if those subjects could have been included.
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Effectiveness of Ergonomics Intervention Programs

The potential to reduce MSD occurrence by reductions in occupational ergonomic

exposures is demonstrated in principle by the occurrence of attributable morbidity

itself. The proportion of musculo-skeletal injuries and illnesses that are work-related are by definition preventable, as are their costs to employers, to workers, and

to society. For example, it has been estimated that at least 50 percent of all workrelated musculoskeletal disorders among the working population could be prevented

by appropriate ergonomic job design (104, 105). Policy-making on other occupational

hazards has not required separate intervention studies; if higher exposures lead to

higher prevalence or incidence, then it follows that reductions in exposure would

lead to reductions in morbidity.

Some scientific evaluations of ergonomic programs have been undertaken, and

these have shown mixed results. A key problem is that any workplace is a highly

dynamic institution. Rather large and expensive studies are needed to address all

possible risk factors for MSDs in a rigorous manner, and yet the scientific investigator has no control over external or internal events that might occur during the

study period. After the study has been initiated, the employer might reverse a decision to implement fully a set of ergonomics recommendations, or a facility might be

closed or downsized, or new national legislation on disease reporting might be introduced (106).

Nevertheless, the scientific literature contains numerous examples of intervention

studies that document the practical and economic feasibility of workplace ergonomic

programs. Effective abatement measures range from well-designed training programs to workstation redesign (107). Reductions in frequency and/or severity of

work-related MSDs have been demonstrated in manufacturing as well as in other

economic sectors. For example, in motor vehicle manufacturing, ergonomic control

measures have been effectively implemented both at the level of the job and in the

organization of the production process (e.g., 108–110). Decreases in MSDs among

VDU operators can similarly be achieved by provision of adjustable furniture, training sessions to facilitate workers’ knowledgeable adjustment of workstations and

work schedules, and early reporting systems that aided employers in assisting individual workers before they became too severely injured to benefit from workplace

measures (61).

The most effective ergonomics programs appear to be those with multiple, coordinated activities, including workstation improvements, provision of adjustable furniture, training to facilitate workers’ knowledgeable adjustment of workstations and

work schedules, and enhanced medical surveillance and management systems that

aid employers in assisting individual workers before they became too severely injured to benefit (111–120). Shannon et al. found that, in general, lower injury rates

are consistently associated with workplace characteristics such as workforce empowerment and top management’s active leadership plus delegation of decision-making authority regarding occupational safety (121).

The economic benefits of such improvements should be taken into account when

attempting to estimate the cost of ergonomic interventions. It has been reported

that tasks identified by workers as having the highest physical demands were far

more likely than other tasks to result in quality defects that were not detected until

the final inspection stage (122), and that an automobile assembly system designed

on the basis of ergonomic principles reduced through-put and idle time, improved

car quality, enhanced production flexibility and operator competence in handling a

varied mix of vehicle options, and reduced production space requirements (109).

Pay-back periods could be substantially less than one year if full-cost accounting

methods were used to assess comprehensively both the costs and benefits of ergonomic programs (123).

Conclusions

Many employers voluntarily utilize ergonomic principles to improve working conditions, and they often report economic and other benefits from such programs. Nevertheless, work-related musculoskeletal disorders still occur with high frequency.

Thus we must conclude that existing incentives are not sufficient.

Not all MSDs occur in relation to work demands, but individuals with high exposures to ergonomic stresses are at substantially increased risk. The considered opinion of many scientists, internationally, is that the scientific literature on work-related MSDs overwhelmingly demonstrates a causal relationship between occupational physical ergonomic stressors and musculoskeletal disorders.

The fundamental principles of public health practice emphasize the prevention of

injury and illness. While there may be debate about the specifics of what an ergonomic standard should contain, there should no longer be any debate that some

MSDs can be prevented. Workplace ergonomic programs, including early reporting,
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training, and job redesign, are a feasible and effective means for reducing the occurrence and severity of MSDs. Public policy measures are required to ensure prevention of unnecessary injury, illness and disability.

Senator SPECTER. Thank you very much, Dr. Punnett. We turn

now to Dr. Franklin Mirer, Director of Health and Safety, United

Auto Workers.

STATEMENT OF DR. FRANKLIN E. MIRER, DIRECTOR, HEALTH AND

SAFETY, UNITED AUTO WORKERS

Dr. MIRER. Thank you very much, Senator, for the privilege of

testifying here. And I can tell you that in the auto industry we do

have a consensus. We have a consensus that there are work-related

musculoskeletal problems. It is our leading cause of injury and illness.

Senator SPECTER. Employers agree with that?

Dr. MIRER. Yes, they do. And we have consensus on how to measure it using pretty much the same measures across three auto companies. We have consensus on how the program ought to be structured. That is our ergonomics program. And we arrive at that

under a deadline which is the end of the auto contract.

Each round of auto bargaining, we improve the ergonomics program. Now, we do not have a consensus that a standard is needed,

although I think we would be pretty close to a consensus that the

rest of the industry, including our parts suppliers, ought to be

doing a better job. And we are continuing in the effort to do that,

both the UAW and with some limited support from management.

So this is kind of a—some of this argument is alien to us.

Now, yesterday, I was called by one of our several hundred hourly ergonomics reps, local union reps, this one from a parts plant in

Flint. She was preparing an invited presentation to a symposium

at the American Industrial Hygiene Association in New Orleans.

She is their local expert on the workings of government, having

been one of 20 UAW local union witnesses who testified on the

standard in Washington, Chicago and Portland. And she had the

pleasure of being cross-examined by Mr. Fellner at time to clarify

her answers. She told me as recently as——

Senator SPECTER. I’m sorry. I didn’t hear that. She had the

what?

Dr. MIRER. She had the pleasure of being cross-examined by Mr.

Fellner.

Senator SPECTER. I thought that is what you said.

Dr. MIRER. She told me that as recently—never laid a glove on

her.

She told me that as recently as this Tuesday, a member approached her on the plant floor to ask if they were going to lose

ergonomics because of the vote in Congress. She says that fear has

been raised in local union meetings repeatedly on the plant floor

the day after the Senate vote.

And I submit that as evidence that the real experts, the hourly

people doing ergonomics in the plant, the engineers, the shop floor

workers all know what it is about and all think it is needed.

And her answer was, do not worry, we have ergonomics in the

contract with UAW. We are never going backwards.

But her problem is, and everyone’s problem is it is hard to get

upfront money to fix problems in good economic times, in the re-
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cent good economic times. Now that it is getting harder, preventive

maintenance even to keep production running smoothly is hard to

come by.

I am afraid we are going to be doing some sideways stepping.

Our major employers foresaw no changes required in their

ergonomics programs as a result of the new standard. And we are

moving to enhance it.

But we all know that we sought that standard as a safety net

against future cutbacks and as a floor for building on in other facilities. So we fear that we might end up with the safety net gone

in free-fall or climbing on air.

Now, very quickly in terms of effectiveness of programs, 60 percent of the injuries in the auto sector are musculoskeletal disorders. Practical ergonomics programs became fully effective in

1994 really, and since then we have shown a 35 percent reduction

averaged over the whole three sectors in injuries.

But that is an average. Some places are doing better than others.

Our methods for relieving ergonomic stresses and procedures for

carrying out practical ergonomics are established. We teach that

scientific basis using some of these researchers to local union representatives.

We have funded research. A lot of this research has been conducted in the auto industry including some joint funding and

NIOSH funding of Dr. Punnett’s work. It is pretty straightforward.

So the consensus in manufacturing, on how to go forward, how

to design equipment, how to measure stresses, how to retrofit problems, some of this information is on open web sites of the industry.

Where we do not have consensus and where as you have heard

here, actually, it might be close to consensus but they are demanding unanimity, we do not have consensus on the need for a standard or some of the fine details of the standard.

PREPARED STATEMENT

But everybody is doing this more or less the same way than are

trying to take care of their workers and get a product out the door,

a quality product out the door on time. And we need that codified,

the practices of the industry leaders codified so we can pull along

the followers, the laggards and the outlaws. Thank you very much.

[The statement follows:]

PREPARED STATEMENT OF DR. FRANKLIN E. MIRER

This testimony is on behalf of the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America, UAW and its 1.3 million active and retired members. Equally importantly, this testimony is on behalf of tens

of millions of American workers exposed to ergonomic hazards who are not represented by a labor union.

UAW members assemble vehicles and make parts for the Big 3 auto makers, and

also produce 18-wheelers, construction equipment, locomotives and the Space Shuttle. Their employers are industrial giants. We also represent nearly 300,000 employees of 1,500 private and public employers in 2,800 bargaining units whose average

size is 100. In addition, our units include warehouses, schools, cafeteria workers,

health care and social service agencies. These statistics demonstrate the depth and

range of the UAW’s experience with ergonomics programs in both manufacturing

and non-manufacturing sectors.

The UAW’s extensive experience with ergonomics programs holds answers to all

the questions the members of this Subcommittee pose: Is an OSHA ergonomics

standard needed? Is there sound science to support an ergonomics standard? Is an
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1Most recent detailed industry data available are for 1998. These analyses are for the 1997

database, which is not materially different.

ergonomics standard consistent with industry practice? Is an ergonomics standard

feasible? Is an ergonomics standard applicable and feasible in all sectors of the economy? The answer to each of these questions is a resounding ‘‘yes.’’ The actions such

a standard would require are not only feasible, they are already commonplace in

hundreds of UAW-represented workplaces.

The UAW appreciates that this Subcommittee is interested in hearing the current

state of the debate on ergonomics. We would have preferred that this debate had

been more fully aired before the Senate voted on, and the President signed, the Resolution of Disapproval of OSHA’s ergonomics program standard.

The UAW strongly supported OSHA’s ergonomics program standard as a modest,

but critical, first step toward abating the largest single cause of injury and disability

among American workers generally, and UAW members in particular. The OSHA

rulemaking provided an oasis of science amid a desert of lobbying and sound bites.

Then, the logic of power overwhelmed the power of logic, and the rule in place was

repealed. We are not here to re-debate the disapproval resolution, however. We are

here to argue that Congress, having eliminated the protections afforded by the

ergonomics standard, should mandate that OSHA issue another enforceable

ergonomics standard regulation by a time certain.

The purpose of Federal standards is to codify the practices of industry leaders so

that industry followers can adopt those practices while exposing industry laggards

and outlaws for what they are. There are literally thousands of consensus safety

standards, set by industry to regulate itself. The large majority of OSHA standards

are actually outdated, 1970’s vintage consensus standards. OSHA standards, adopted through an open, evidence-rich process, may stretch the industry leaders, but

they are particularly hated by the laggards because management has to comply,

rather than merely being invited to comply.

The UAW testimony today will emphasize the following key points:

1. Ergonomics programs are the only means to prevent the majority of injuries

suffered by American workers in the automobile industry, and the manufacturing

sector generally. Approximately 60 percent of injuries in the auto sector are

muskuloskeletal disorders.

2. Practical ergonomics programs are in place in hundreds of worksites and have

set the stage for major progress.

3. The Bureau of Labor Statistics 1998 and 1999 surveys show the effectiveness

of UAW-negotiated ergonomics programs.

4. Methods for measuring and relieving ergonomic stresses and procedures for carrying out practical ergonomics programs have been developed and verified over the

last decade. The science is well established.

5. The principal need over the next decade is accelerating abatement of exposure

to physical stresses.

6. The UAW has developed and implemented an ergonomics model for small manufacturing suppliers and office and professional facilities which demonstrates that

ergonomics is necessary and feasible in such facilities. These programs also establish industry recognition of MSD risk factors and the elements of a program needed

to protect employees.

7. The OSHA rulemaking process was itself a massive data collection and analysis

effort that collected information not previously available to support an ergonomics

standard.

8. Both the second National Academy of Sciences 2001 review and the new

ACGIH standard for Hand Activity Level limit demonstrate a scientific consensus

in support of ergonomics interventions.

9. In conclusion, the ergonomics standard is necessary, feasible and appropriate.

Each of these points is discussed in detail below:

1. Ergonomics programs are the only means to prevent the majority of injuries

suffered by American workers in the automobile industry, and the manufacturing

sector generally. Approximately 60 percent of injuries in the auto sector are

muskuloskeletal disorders.

The need for ergonomics abatement is most clearly shown in the Bureau of Labor

Statistics (BLS) Disabling Injury reports.1 These studies compile employer-supplied

data on the types and causes of injuries and illnesses that result in days away from

work. The employer data are a sample of OSHA 101 forms for cases with days away

from work.

OSHA relied on this same database. We concur with OSHA that these employersupplied data probably under-report musculoskeletal disorders. However, the data

portray the full extent of the problem.
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In the motor vehicle parts sector (SIC 3714), the employment category of in the

auto industry with processes most common to other manufacturing industry and

with the most small establishments, 54 percent of disabling conditions are identified

by management as strain or sprain injuries and various cumulative trauma diagnoses which are properly grouped as MSD’s. In addition, about 20 percent of disabling injuries were in the ‘‘other’’ category, which includes some MSD’s. Therefore,

the large majority of disabling conditions are MSD’s. For auto parts, 40 percent of

injuries were coded as arising from repetitive motion or overexertion, with an additional 11 percent in the ‘‘other’’ category. Back injuries are the largest single diagnosis in this sector, 22 percent, and shoulder injuries are 7 percent. Back and shoulder injuries are almost entirely of ergonomic origin. In short, injuries preventable

by ergonomics programs dominate the disabling injuries in the motor vehicle parts

sector, and manufacturing in general.

These data demonstrate that the biggest problems now faced by safety specialists

and suffered by workers are hazards that can be abated only by ergonomics programs.

2. Practical ergonomics programs are in place in hundreds of worksites and have

set the stage for major progress.

Every UAW-represented location in the Big 3 auto companies has a labor-management ergonomics committee in addition to a labor-management health and safety

committee. These approximately 300 facilities employ about 350,000 hourly workers

and additional salaried personnel, and represent a substantial fraction of the U.S.

Gross National Product. The two UAW-represented international transplant assembly plants use the same structure. Labor and management representatives on these

committees are trained to analyze injury and illness data to identify high injury

jobs; to conduct risk factor analyses; and to identify solutions to reduce ergonomic

stresses. Dozens, if not hundreds, of smaller UAW-represented parts suppliers have

adopted this model as well. UAW members in the service, clerical and public sectors

have been able to implement similar programs. These programs are described in

more detail below.
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The common ergonomic abatement process used by these committees is shown in

the accompanying flowchart. Ergonomics is a continuous improvement process with

no clear endpoint. In fact, participants believe that ergonomics improvement is integral to a high performance manufacturing system, just as quality improvement is.

Initially, these UAW ergonomic programs grew from massive penalty OSHA citations for failure to record injuries and illnesses, and from citations under the General Duty Clause. The programs were later codified in labor contracts. Labor and

management representatives argue about the best way to do things and whether

change is fast enough, but the need for an ergonomics process on this model is no

longer in dispute. Our ergonomics programs have been shown to reduce worker injuries and to increase productivity.

Ergonomics program activity goes well beyond the vehicle assembly, stamping,

parts manufacturing and parts distribution facilities of the Big 3 auto makers. Similar but less elaborate programs following the same model, including job analysis

methods and labor management structure, have been implemented in many smaller

UAW represented workplaces. Ergonomics committees at these facilities are often

trained by UAW professionals. We have done this in parts plants, bicycle plants, a

health maintenance organization, in clerical settings and among public employees.
155

3. The Bureau of Labor Statistics 1998 and 1999 surveys show the effectiveness

of UAW-negotiated ergonomics programs.

Analysis by the UAW of the most recent government statistics shows that safety

and ergonomics programs prevented over 69,000 occupational injuries and illnesses

in 1998 in the vehicle assembly and parts sectors. Of these, at least 41,000 were

musculoskeletal problems prevented by ergonomics programs.

These data are derived from the Bureau of Labor Statistics’ annual injury and illness survey data for 1998, released in December 1999. Reductions in injury rates

reported for key UAW workplaces give strong evidence for the effectiveness of UAW

safety and health programs generally, and especially for the value of our ergonomics

programs.

The UAW believes that the motor vehicle assembly (SIC 3711), motor vehicle

parts (SIC 3714) and automotive stamping (SIC 3465) sectors have gone farther

than most others in implementing ergonomics programs. My testimony concentrates

on the auto parts sector. We selected 1994 as the baseline, because that is when

ergonomics programs were first likely to be fully implemented, and also to obtain

a five year period. For the auto parts sector, the total case rate dropped 12 percent

over one year and 33 percent over five years, while the occupational illness rate fell

17 percent over one year and 34 percent over five years. Cumulative trauma disorders declined 13 percent and 24 percent respectively.

Over this same period the total case rate, injury rate and CTD rate fell slightly

for all private employment, while the illness rate increased by a small amount. The

vehicle assembly rate however, dropped 5.5 times as fast as the national average

over five years, while auto parts dropped 4.5 times as fast. Percentage reductions

were 40 percent greater in vehicle assembly and 70 percent greater in parts manufacturing compared to all employers combined.

The 1999 data, which did not become available until December 2000, show an additional 5 percent drop in total rate across the three main auto-related sectors. This

evidence of continuing improvement was not included in the record of the OSHA

hearings.

These data show that ergonomics programs decrease the number of worker injuries, with attendant savings to employers as well.

4. Methods for measuring and relieving ergonomic stresses and procedures for carrying out practical ergonomics programs have been developed and verified over the

last decade. The science is well established.

The important technical developments for effective ergonomics programs emerged

two decades ago, and the broad outline is now largely in place. The driving force

was combining the engineering and biomechanics disciplines with medical science

and epidemiology. The University of Michigan and NIOSH are the key institutions
156

2The NAS ergonomics report responds to seven questions posed by Congressman Livingston:

1. What are the conditions affecting humans that are considered to be work-related musculoskeletal disorders? 2. What is the status of medical science with respect to the diagnosis and

classification of such conditions? 3. What is the state of scientific knowledge, characterized by

the degree of certainty or lack thereof, with regard to occupational and non-occupational activities causing such conditions? 4. What is the relative contribution of any causal factors identified

in the literature to the development of such conditions in (a) the general population; (b) specific

industries; and (c) specific occupational groups? 5. What is the incidence of such conditions in

(a) the general population; (b) specific industries; and (c) specific occupational groups? 6. Does

the literature reveal any specific guidance to prevent the development of such conditions in (a)

the general population; (b) specific industries; and (c) specific occupational groups? 7. What scientific questions remain unanswered, and may require further research, to determine which occupational activities in which specific industries cause or contribute to work-related musculoskeletal disorders? 3Lida Orta-Anes, Ph.D., ergonomist, UAW Health and Safety Department, was invited to

present a discussion paper on UAW experiences and her views of the scientific evidence.

that have established the United States at the forefront of the science of ergonomics.

The technical developments include:

—Development of consistent methods to measure the physical stresses on the

human body. Stress is determined by the force exerted on a body part, the frequency of the motion, and the posture of the joint. The Force-Frequency-Posture

paradigm is common to both expert and checklist approaches to ergonomic analysis;

—Acceptance of expert ergonomic analysis for measurement of risk factors according to these methods;

—Development of simplified non-expert approaches to measurement of risk factors

(checklists);

—Formulation of the NIOSH lifting guide and related biomechanical models

which take into account the weight of an object, distance from the body, and

motion of the body in lifting;

—Validated semi-quantitative risk factor checklists for hand, arm and shoulder

(upper extremity) cumulative trauma disorders;

—Diagnostic criteria for upper extremity CTD’s;

—Standardized physical examination protocols for upper extremity CTD’s;

—Validation of symptom surveys and discomfort surveys (psychophysical measures) as risk factor identification tools;

—Validation of risk factor checklist and symptom survey by workforce personnel

to identify high risk jobs and propose abatement methods;

—Acceptance of the plant ergonomics committee model, especially lay analysis of

risk factors using standardized checklists.

These scientific developments rest on an enormous body of published work as well

as practical experience. In 1997, NIOSH published a massive compilation of

ergonomics studies. The UAW believes that the NIOSH compilation and analysis of

virtually all available studies of work-related musculoskeletal disorders settles the

question whether there is sufficient science underlying ergonomics. The studies

show exposure-response relationships for ergonomic stress factors and musculoskeletal disorders of each body part. NIOSH did an excellent evaluation of hundreds

of reports to show the weight and strength of the evidence for cause and effect relationships, and conclusively confirmed that increased stress causes increased injury.

Nonetheless, Congress subsequently funded a review of this issue by the National

Academy of Sciences.2 A steering committee was established in May 1998, under the

auspices of the NAS Committee on Human Factors.

NAS studies typically consist of literature reviews and presentations at open

meetings, followed by a report drafted by the expert committee and reviewed by the

Academy members and other peer reviewers. The ergonomics study involved an

open workshop attended by 66 leading technical experts. The UAW participated in

this workshop 3, presenting evidence of our experiences with ergonomics programs.

The NAS issued a report on the study in 1999. The summary conclusion was: ‘‘Scientific research clearly demonstrates that effective work place interventions are

available which can reduce ergonomic hazards and prevent musculoskeletal disorders. There is evidence that interventions are cost-beneficial for employers.’’ The

report thus validated the scientific conclusions cited by OSHA as the basis for its

decision to move forward with an ergonomic standard.

In 1998, Congress commissioned a second NAS study of the same issues.

This section has summarized the state of knowledge when the ergonomics standard was proposed and the hearings began. Below we discuss subsequent scientific

developments that further support the need for an ergonomics standard.
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5. The principal need over the next decade is accelerating abatement of exposure

to physical stresses.

Many case histories show improved health outcomes on jobs where risk factors

had been reduced. Many facilities report reduced injury rates after implementing

ergonomics programs. Scientific studies show reduced injury rates and symptom

complaints after job changes. These case studies were reported in the NIOSH conference and are regularly presented at professional meetings. The data presented

above show sector-wide reductions in MSD rates in the sector with the most advanced ergonomics activities. These successes are reasons for government to keep

pressure on employers to abate ergonomic hazards.

The principal problem plant ergonomics committees report is not being able to get

high-risk jobs fixed in a timely fashion. High-risk jobs are jobs where injuries have

already been recorded. Solutions are usually identified directly from the risk factor

analysis: the job task must be changed to reduce the force, limit the number of repetitions of the same motion, or allow the worker to do the job in a neutral posture.

Routine solutions include raising loads off the floor with lift tables, adjusting the

height of work, reducing the reach to get or place parts, damping vibration, placing

the tool or the work in a fixture, reducing or counterbalancing tool weight. Many

tricks of the trade are known to engineers and workers alike. People from the workplace know job changes that will allow the work to be done and reduce the stresses.

Virtually all these solutions improve quality and efficiency and therefore increase

productivity.

Nevertheless, to solve ergonomics problems and to reduce injury rates in the long

term, an employer has to invest time and money up front. Unless pressure for job

improvement is maintained, employers will resist accepting their responsibility.

The principal improvement in ergonomics programs achieved in the 1999 round

of auto contract negotiations was adoption of specific time limits for the job improvement cycle. In all three auto agreements, management committed that a job will be

analyzed within two months of the report of a work-related musculoskeletal disorder

and modified to abate identified risk factors within six months of completion of the

analysis. In addition, design criteria for new equipment are incorporated into the

joint new equipment safety reviews. Some of these criteria are available to suppliers

over the internet.

6. The UAW has developed and implemented an ergonomics model for small manufacturing suppliers and office and professional facilities that demonstrates that

ergonomics is necessary and feasible in such facilities. These programs also establish industry recognition of MSD risk factors and the elements of a program needed

to protect employees.

The UAW has implemented ergonomic interventions at approximately 45 smaller

UAW-represented worksites over the past five years. The optimal intervention involves all the elements of the OSHA standard, except that MSD management typically falls short of the OSHA proposal.

The essential element of the intervention is training a worksite ergonomics committee to analyze jobs and suggest interventions. In UAW-represented facilities, this

training is primarily conducted by peer trainers, called Local Union Discussion

Leaders (LUDL’s). LUDL’s are full-time employees at UAW-represented facilities.

They are shop floor employees who move into a trainer position because of their interest and demonstrated training skills. These persons are released from work on

union leave at UAW request to conduct training-related activities. LUDLs assigned

to ergonomics training are usually ergonomics committee members at their home facility. They have all taken at least a 40-hour course, conducted job analyses, received training technique instruction and been fully evaluated by UAW Staff and

University of Michigan training evaluation staff.

Our experience with this training method indicates that because it is based on

hands-on activities, it ensures retention of information. The small group discussion

and problem-solving allows for direct learning from peers with experience in the

topic. The training includes extensive case studies through the use of videos. In addition, it is delivered at the site. It includes a component where participants evaluate real jobs on the shop floor, in real time.

The UAW has implemented successful ergonomics programs using this training

at numerous small businesses, including Jaquith Industries (Local Union 1128) in

Syracuse, New York. With the completion of a recent 40-hour Practical Ergonomics

Training (PET) program, Jaquith workers are now able to evaluate problem jobs

and develop solutions. Some jobs in this shop are presently being re-engineered to

eliminate job hazards. In a recent letter to the UAW Health and Safety Department

from Jaquith’s owners, they praised and credited UAW’s Health & Safety Department grant staff for a professional job in helping them to assess their ergonomics

concerns and offering solutions to the problems they faced.
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Other small employers who have worked with the UAW to establish successful

ergonomics programs include: Recycle Ann Arbor (Local Union 157) in Ann Arbor,

Michigan; Bosch Braking Systems (Local Union 2155) in Johnson City, Tennessee;

United Defense Systems (Local Union 683) in Minneapolis, Minnesota; Sidler Corporation (Local Union 417) in Madison Heights, Michigan; and AP Parts (Local

Union 12) in Toledo, Ohio.

7. The OSHA rulemaking process was itself a massive data collection and analysis

effort that collected information not previously available to support an ergonomics

standard.

The Subcommittee should take note of the remarkably open nature of an OSHA

standard hearing. Prior to a hearing, OSHA issues the proposal and explanation,

and invites written comments. The hearing starts with the OSHA team that wrote

the standard appearing on stage taking questions from all comers, industry and

labor, explaining and defending the proposal on the record. Then, OSHA presents

experts who appear and face questioning by all parties under the same ground

rules.

After OSHA has laid out its proposal and its evidence, anyone with an opinion

can submit evidence and present oral testimony. However, the price of appearing

before the team that will write the standard is taking questions from participants

from industry, labor and OSHA, also on the record. For questioning of witnesses

during the ergonomics hearings, labor and OSHA relied principally on subject matter experts rather than on lawyers. United Parcel Service, the main opponent of the

ergonomics rule, requested two and a half days of testimony, then dropped nearly

all its witnesses and took just a couple of hours, thereby crowding out other evidence and limiting the time of other witnesses.

The ergonomics standard had been under consideration for ten years, initiated by

then-Secretary of Labor Elizabeth Dole. OSHA invited stakeholders to participate

in many meetings to discuss key issues in the rule before a proposed standard was

issued. NIOSH held an open invitation national conference to present best practices.

OSHA held a series of regional open invitation best practices conferences. There was

every opportunity for pre-proposal input to all interested parties. The UAW participated in many of these events. Participation included several joint labor-management presentations of facility experiences.

A working draft of the ergonomics standard was reviewed by small business representatives under the SBREFA process, beginning in February, 1999. OSHA, together with the Office of Management and Budget and the Small Business Administration created a panel to review and comment on a working draft of the standard.

The panel sought the advice and recommendations of potentially-affected small entity representatives, consulting with 21 persons. This included a face-to-face meeting

on March 24–26, 1999. The UAW notes with concern that small business representatives were given special status and access to rulemakers to ask questions and

make comments before workers and the public had an opportunity for similar input.

Nevertheless, in accordance with law, the SBREFA panel submitted a report to

OSHA on April 30, 1999.

The SEBREFA panel made 36 recommendations to OSHA concerning the

ergonomics standard. OSHA responded to each one of them, as detailed in the preamble of the proposed rule. Some comments resulted in modifications to the cost estimates of the standard. Others resulted in clarifications or changes to the explanation of the regulatory text. Finally, several changes in the regulatory text were

made in response to recommendations. These changes included: removing a provision that employers must analyze jobs with ‘‘known hazards;’’ providing a step-bystep incremental abatement process; and modifying the medical management program to reduce potential cost to employers.

The UAW notes that some of the changes made in response to small business recommendations—in particular the incremental abatement process—later became the

basis for criticism by business representatives.

The OSHA hearings spanned 44 full days of testimony and questioning in Washington, Chicago, Portland, and Atlanta, involved about 900 witnesses, and generated

18,833 pages of transcript. The full transcripts were posted on OSHA’s website to

be downloaded and reviewed, as well as lists of exhibits. This open access to the

complete record had no precedent in previous rulemaking.

The UAW presented testimony at three sites. Presenters included 11 local union

representatives from automobile industry facilities; nine local union representatives

from other sectors, including parts suppliers, agricultural implement, truck, appliances, joint ventures, private sector clerical and public employees; the UAW coproject manager for ergonomics from each of the three auto collective bargaining departments presenting the joint program at that company; and three Health and

Safety Department representatives. The UAW also submitted about 200 pages of
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4Dr. Bradley Joseph and Dr. Gordon Reeve, Ford Motor Company, and Dr. Franklin E. Mirer,

UAW Health and Safety Department. 5Ford Livonia Transmission Plant and UAW Local 182, and Ford Michigan Truck Plant and

UAW Local Union 900.

written testimony and commentary as well as training materials and ergonomics

manuals developed by the joint UAW-company programs. (The UAW notes that the

jointly developed and validated UAW-GM Risk Factor Checklist was recognized by

OSHA as a valid means of evaluating ergonomic risk factors.)

The UAW points out that the experiential data presented by local union representatives and staff are rarely available to an agency or to the public through the

published literature. Yet, this evidence is crucial to the practical validation and application of biomechanical and epidemiological analyses in the real world. The

OSHA process thus created a large and valuable new base of data.

Additionally, OSHA presented several panels of leaders in occupational medicine,

ergonomic analysis, engineering and regulatory analysis applied to ergonomics programs. These were all published authorities whose work was available in the open

literature. However, the invited testimony made these persons available for questioning on the specific points that management and labor stakeholders thought to

be material to a standard. The dialogue in the hearing transcripts provides an additional large new base of data on which to develop ergonomic knowledge.

The OSHA team that had drafted the proposed standard sat through each of these

hearings, as did the key labor and management representatives.

8. Both the second National Academy of Sciences 2001 review and the new

ACGIH standard for Hand Activity Level limit demonstrate a scientific consensus

in support of ergonomics interventions.

On January 18, 2001, the National Academy of Sciences (NAS) and Institute of

Medicine (IOM) released their long-awaited report on Musculoskeletal Disorders and

the Workplace (‘‘NAS II’’). The report, requested by Congress, confirms yet again

that there is strong scientific evidence that exposure to ergonomic hazards in the

workplace causes musculoskeletal disorders and that these injuries can be prevented by ergonomic interventions.

The study was not an ivory tower effort. The study committee traveled to Detroit,

heard a presentation on the state of the art in the auto industry, toured auto plants

accompanied by UAW and Ford staff,4 and heard from local ergonomics committee

members, labor and management, who do the work every day.5

The NAS II report confirms that the exposures addressed by the OSHA standard—heavy lifting, awkward postures, repetition, force and vibration—cause back

injuries and/or upper extremity injuries like carpal tunnel syndrome. It also found

that a programmatic approach tailored to individual workplaces, such as that set

forth in the OSHA standard, is the most effective means to reduce MSDs. Specific

major findings of the study include the following:

‘‘There is no doubt that musculoskeletal disorders of the low back and upper extremities are an important and costly national health problem . . . In 1999, nearly

1 million people took time away from work to treat and recover from work-related

musculoskeletal pain or impairment of function in the low back or upper extremities. Conservative estimates of the economic burden imposed, as measured by compensation costs, lost wages, and lost productivity, are between $45 and $54 billion

annually.’’ (Page ES–1)

‘‘The panel’s review of the research literature in epidemiology, biomechanics, tissue mechanobiology, and workplace intervention strategies has identified a rich and

consistent pattern of evidence that support a relationship between the workplace

and the occurrence of MSDs of the low back and upper extremities.’’ (Page ES–3)

‘‘The panel concludes that there is a clear relationship between back disorders and

physical load; that is, manual material handling, load movement, frequent bending

and twisting, heavy physical work, and whole-body vibration. For disorders of the

upper extremities, repetition, force and vibration are particularly important workrelated factors.’’ (Conclusion 3, Page 11–10)

‘‘The weight of the evidence justifies the introduction of appropriate and selected

interventions to reduce the risk of musculoskeletal disorders of the low back and

upper extremities.’’ (Page 11–2)

‘‘To be effective, intervention programs should include employee involvement, employer commitment and the development of integrated programs that address equipment design work procedures and organizational characteristics.’’ (Conclusion 8,

Page ES–6 and 11–2)
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Opponents of an ergonomics regulation promptly issued press releases stating

that this report discredited the scientific basis for the OSHA standard. We ask the

members of this Subcommittee to judge for yourselves.

Equally compelling was action by the American Conference of Governmental Industrial Hygienists (ACGIH) on December 10, 2000. The ACGIH is the dominant

private entity that issues occupational health standards. ACGIH standards are

internationally recognized and given deference by many governmental authorities

outside of the United States.

The ACGIH preface states:

‘‘ACGIH recognizes work related musculoskeletal disorders (MSDs) as an important occupational health problem that can be managed using an ergonomics health

and safety program—Some of these disorders fit established diagnostic criteria such

as carpal tunnel syndrome or tendinitis. Other musculoskeletal disorders may be

manifested by nonspecific pain. Some transient discomfort is a normal consequence

of work and is unavoidable, but discomfort that persists from day to day or interferes with activities of work or daily living should not be considered an acceptable

outcome of work.’’

The ACGIH adopted a Threshold Limit Value (TLV) for hand activity level and

issued a notice of intended change to adopt a TLV for lifting.

Hand Activity Level is a numerical function of peak hand force, frequency and duration of exposure. The TLV includes an action level, below the exposure limit. The

standard notes that:

‘‘Professional judgment should be used to reduce exposures below the action limits

recommended in the HAL TLV’s if one or more of the following factors are present:

‘‘—Sustained non-neutral postures such as wrist flexion, wrist extension, wrist deviation, or forearm rotation;

‘‘—Contact stresses;

‘‘—Low temperatures; or

‘‘—Vibration.

‘‘Employ appropriate control measures anytime the TLV’s are exceeded or an elevated incidence of work-related musculoskeletal disorders is detected.’’

9. In conclusion, the ergonomics standard is necessary, feasible and appropriate.

The underlying premise of any OSHA standard is that an employer who knows

a job has injured an employee must take feasible steps to make the job safer. Few

would disagree with the propriety of this premise. This applies equally to

ergonomics. The UAW, our auto industry employers, and many smaller employers

have demonstrated that ergonomics programs are a ‘‘win-win’’ for both management

and employees. In many of our worksites, ergonomic risk assessment techniques are

applied predominantly by hourly workers who, in turn, have been trained by other

rank-and-file workers. These methods both measure hazard and validate abatement.

Ergonomics programs works. It is time to get down to the business of applying

ergonomics.

Senator SPECTER. Dr. Mirer, from what you have said, then, does

the auto industry, UAW and manufacturers need an ergonomics

regulation or have you not pretty much solved the problem yourself?

Dr. MIRER. No. The problem is never solved and we bargain over

it actually every 3 years. It is a continuous improvement process.

And we need the standard as a safety net for when times get hard.

Senator SPECTER. The standard as a safety net. But on an ongoing basis you are pretty well working it out from what I hear in

your testimony.

Dr. MIRER. We have been making progress in good times. We are

going into bad times now and things——

Senator SPECTER. Well, your experience is obviously not determined in there for all of the industry. You have a very mature industry in automobiles. And you have good bargaining power. And

the UAW and the employers, when you say consensus, that is nice

to hear, even though it is limited. But you would still like to have

an ergonomics regulation from a Federal Government, but as you

say from a safety net.
161

Dr. MIRER. For the three car companies, for the IPS sector, for

the supplier sector, the small plants sector, we absolutely need that

standard as a floor that we can build on and move forward.

Senator SPECTER. You need a standard forum from some of the

suppliers. Well, has the UAW not been successful on your bargaining strength to get a reasonable result from that group?

Dr. MIRER. We are far from where we ought to be in that group.

Senator SPECTER. How do you account for the difference being far

from where you ought to be in that group in contrast to where you

are in the industry generally?

Dr. MIRER. It is a contrast of combination of collective bargaining, technical resources and the ability of suppliers to turn

over their workforce and run away.

Senator SPECTER. Well, I think that the model that you have described though from the most of the industry of the UAW is a good

one to be followed. Maybe it needs some sharpening up on it, but

it is a lot better to hear that you need a safety standard than you

are on each other’s throats and cannot agree to anything.

Dr. MIRER. Absolutely.

Senator SPECTER. Dr. Hadler, what do you think of Dr. Punnett’s

testimony that musculoskeletal pain is proportionate to physical

work? I do not have her exact words. They were too complicated

and too long and I could not write them all down but that is the

thrust of it.

Dr. HADLER. When I was a medical student, epidemiologists observed that the risk for Down’s Syndrome, trisomy 21, was not uniform in sibships. The youngest child was more likely to be afflicted

with this congenital disorder.

Senator SPECTER. Does this turn out to be responsive to my question?

Dr. HADLER. It is a direct response.

Senator SPECTER. I am not sure about that. I disagree with that

already.

But if it is indirect, I will take it.

Dr. HADLER. We are working on consensus. Give me about another two paragraphs.

Senator SPECTER. Okay.

Dr. HADLER. That leads to the hypothesis and research——

Senator SPECTER. Chairman gets very impatient when you have

got about 40 witnesses.

Dr. HADLER. I hear you. I will be within my 5 minutes.

Senator SPECTER. I am not necessarily giving you 5 minutes, Dr.

Hadler. I want you to respond to my question. You have had 5 minutes.

Dr. HADLER. The answer is, if I need to respond directly, and the

analogy would help understand it, is that——

Senator SPECTER. Go ahead with your analogy. It will be shorter

than my interruptions.

Dr. HADLER. That lead to hypotheses and research as to what

was it about the multiparous uterus that caused the fertilized egg

to divide abnormally.

Several years later, epidemiologists returned to this issue to test

whether they had missed the real association. The younger the

child in the sibship, the older the mother. Could it be that the like-
162

lihood of bearing a child with Down’s Syndrome associated more

with the mother’s age than the birth rank. The answer proved to

be yes. The old hypothesis was superseded and research shifted to

the biology of the aging ovary.

Several years later, epidemiologists returned to this issue to test

whether they had missed the real association. The older the mother, the older the father. Could it be? The answer was yes and no.

The likelihood of bearing a child with Down’s Syndrome was associated with both maternal and paternal age. The old hypothesis was

superseded and research shifted yet again.

That is the scientific method. We learn from the old hypotheses

and the old false starts and we move on. Today no one would consider studies of the microenvironment of the multiparous uterus as

relevant to the pathogenesis of Down’s. For 60 years, science has

sought associations between physical demands of tasks and the

likelihood of suffering——

Senator SPECTER. Which paragraph are you on now?

Dr. HADLER. That is the direct answer. The physical demands of

task and the likelihood of suffering disabling regional back pain.

For 30 years, there have been parallel studies between physical demands of tasks and disabling arm pain.

Associations have been found, but they are inconsistent and

weak. There were hints 30 years ago, but science has really risen

to the challenge in the past decade, the challenge of asking whether a more important association was being ignored.

A number of cross-sectional and longitudinal studies have attempted to probe for associations between disabling regional back

or arm pain and aspects of both, the physical content of tasks and

the psychosocial context of work.

The result of these multivariate studies is that the associations

with the wide range of physical content of tasks that has been

studied are weaker and even more inconsistent. The associations

with the psychosocial context of work are also weak but they are

more consistent and generally subsume the associations with the

physical content of tasks.

I could belabor this new literature. It deserves scrutiny. However, I cannot applaud the insistence on relying on the older literature in the systematic reviews that are promulgated by NIOSH

and the NRC and Dr. Punnett in her statement.

Any study that considers only the association between the physical demands of tasks and likelihood of a disabling regional musculoskeletal disorder is out of date, even if it is ongoing or proposed. The state-of-the-science has moved beyond the testing of

that hypothesis to newer hypotheses that promise to be more informative.

That is my direct answer, sir. Can I elaborate on it? Because I

had planned to.

Senator SPECTER. I do not know whether it is possible to elaborate on it.

I have just been reading the six paragraphs and I would have to

study and dissect it to understand it. Dr. Punnett, there are two

questions for you. First, did you understand the analogy to Down’s

Syndrome?

Dr. PUNNETT. Well, Senator, I think what Dr.——
163

Senator SPECTER. I have not asked the second question yet. But

go ahead.

Dr. PUNNETT. I think I guess the very short answer is I think

I might have understood it.

Senator SPECTER. Well, when Dr. Hadler disagrees with your

conclusion of muscular pain proportionate to physical work, I am

going to have to study his statement so that I can understand his

reasoning on it.

Dr. HADLER. Can I illustrate with an example?

Senator SPECTER. No. No. You cannot. All right. Go ahead.

Dr. HADLER. Let me tell you briefly about two small area analyses, since they are very easy to follow. There are large companies

that have multiple work sites, each with similar facilities and similar demographics of the workforce. The incidence of disabling back

or arm pain varies from site to site, sometimes dramatically.

That offers the opportunity to explore whether measurable differences in task content, demographics, or psychosocial context associate best with the variability in the incidence of the disabling regional disorders.

Independently, investigators from NIOSH and myself perform

such a small area analysis in U.S. West directory assistance operators. Neither NIOSH nor I could explain the site-to-site variability

in the incidence of disabling arm pain by any aspect of the content

of the task.

However, multiple aspects of the psychosocial context of the work

did associate: Fear of redundancy, work pressure, lack of decision

authority, to mention a few.

Dr. MIRER. That will go over real well in Flint.

Senator SPECTER. Well, I have the statement and I am going to

have to study it candidly to understand it.

Dr. PUNNETT. Senator Specter, could I just elaborate a little bit

on my earlier very quick response?

Senator SPECTER. Just a little bit.

Dr. PUNNETT. I believe that what Dr. Hadler was trying to say

was that he thinks that the hypothesis regarding physical load factors is out of date. He just actually cited a rather old study himself.

But I think that the reviewing process which has gone on in the

scientific peer-reviewed literature, Dutch reviewers, British reviewers, German reviewers, Japanese investigators really are increasingly coming together very much in line with the NAS conclusions.

And the evidence is in fact that even taking account of psychosocial

factors, the evidence in favor of physical load factors is consistent

and continues to be strong.

Senator SPECTER. Dr. Bigos, have you had an opportunity to examine this report that Dr. Barondess referred to?

Dr. BIGOS. Yes, I have.

Senator SPECTER. And Dr. Barondess articulated the issue better

than I had, which would not necessarily take a whole lot, when he

said it adds incremental risk. So it is not a causative factor but an

incremental factor. Do you disagree with that?

Dr. BIGOS. I think that the data is not strong enough to make

that particular association in a way that we can act on it specifically. I think incremental risk is kind of like cardiovascular dis-
164

ease. It is a U-shaped phenomena that we see all throughout the

physical aspects of nature.

That is, people who do not and people who do participate in

something seem to do poorer than people who do things in moderation, whether it be exercise or alcohol as we are finding out.

What I would like to talk about a little bit is the science because

that is what this session is about. And if I could just have a second,

I think that I can make clearer——

Senator SPECTER. Well, if you would be brief. We have two more

panels and it is 11:35.

Dr. BIGOS. No problem. I chaired the HCPR guideline panel for

back problems. That was under the direction of the U.S. Department of Health and Human Services. Because of the recent Dopper

decision at that time, we decided we had to do it not on consensus

or opinions but based on the actual data that was available in the

literature.

We went through a methodologic process of more than 10,000 abstracts and 4,600 studies putting them on paper so that you could

solve for x; better, no better, the same, with different aspects.

The long and short of it is we also applied that within the same

process to the occupational literature as it relates to back problems.

The conclusions are that we found no evidence in the reliable literature, not the literature that gives you a hint that something

might be there but the reliable literature that lets you act.

Senator SPECTER. How did you determine what was reliable? A

little bit of subjective determination there?

Dr. BIGOS. No, sir. I refer to Holly and Cummings who basically

have laid out there are certain studies that provide you with evidence because you have looked at clues. There are certain studies

that only provide you with clues.

Retrospective cross-sectional studies provide you with clues that

have to be studied to see if the clues are correct. Standing on top

of a building and doing a 360 in Kansas would lead you to the determination that the world is flat. But you have to have a better

measuring tool and it has to be subjected to some scientific rigor.

Senator SPECTER. Dr. Bigos, do you disagree with what Dr.

Barondess said also, that there is, well, I know the answer to this

but I will ask it anyway, scientific basis for intervention?

Dr. BIGOS. I thought I saw that there was a call for more research because we didn’t have enough information to be able to be

specific, especially on the back pain——

Senator SPECTER. Did I quote you incorrectly, Dr. Barondess?

You said there was a scientific basis for intervention?

Dr. BARONDESS. I did say that.

Dr. BIGOS. I think that was for the upper extremity. I do not

think it was there for the back, was it?

Dr. BARONDESS. Yes, it was. In fact it is stronger for the back.

Senator SPECTER. Dr. Barondess, when you say it is a 1 percent

issue on the gross national product, I want to be sure I have got

my zeroes in order here, on a $10 trillion gross domestic product,

that would be $100 billion in losses?

Dr. BARONDESS. There have been estimates that high, Senator.

Actually, I wrestled with the zeroes myself and was operating from
165

a smaller estimate of the gross domestic product when these figures were put together.

Senator SPECTER. What estimate were you working on?

Dr. BARONDESS. $5 trillion.

Senator SPECTER. $5 trillion. Looks like the tax cut is going to

have to be reduced then.

Dr. BARONDESS. That is the difference between a scientist and an

economist. We are here to help.

Senator SPECTER. This hearing I think has reached a new milestone in very heavy competition on disagreement. The economists

go over the gross national product and the tax cut and the surplus

and cannot agree on anything. And notwithstanding Dr. Punnett’s

testimony, I think witnesses today have agreed on less.

I guess that is impossible but that is the way it seems to me listening. Dr. Barondess, do you have a formula beyond your conclusions on adding incremental risk and a scientific basis for intervention as to what the intervention ought to be and how you ought to

tackle these various lines?

Dr. BARONDESS. Yes, sir. This is complex territory and the committee’s view is that multiple interventions need to be applied

when interventions are applied. They need to include not alone efforts to ameliorate physical load but need to involve also the workforce in their design, need to involve a commitment from management, need to have something to do with administrative alterations

as well as mechanical alterations.

When Dr. Hadler says something about physical factors as exclusive causes, that is not at all the conclusion the group came to. And

I agree with him that psychosocial factors are extremely important.

As I said earlier, humans are complex and reactive on a number

of levels.

Senator SPECTER. Thank you all very much. We are going to

move to Panel 4, Cost Benefits and Feasibility of Ergonomic Programs. Mr. Dean Sparlin, Dr. Burton, Dr. Derebery, Mr. David Alexander, Mr. Eric Frumin and Mr. Doug Bonacum.

Let me start with you, Mr. Sparlin, if we may. And thank you

for joining us and look forward to your testimony.

STATEMENT OF DEAN SPARLIN, ESQ., GIBSON, DUNN & CRUTCHER,

LLP

Mr. SPARLIN. Thank you, Mr. Chairman. We are here today to

discuss economic issues with six panelists, none of whom is an

economist. I am a lawyer having represented clients in safety and

health matters during more than 14 years of practice.

The reason we do not have an economist here is that we have

not reached the point where one would be useful. So far we have

had a battle between big numbers and mind-numbingly huges

ones.

OSHA told us last year that its ergonomic standard would cost

$4.5 billion per year. Employers countered with cost estimates exceeding $100 billion. Any disagreement of that magnitude has to be

more than mathematics.

What we have here is a basic different vision between the two

sides. The key to resolving that difference is a clear understanding
166

of what a standard would entail, educated by OSHA’s own history

of enforcing similar requirements.

With all due respect, I do not believe that testimonials from

ergonomists and safety and health personnel provide the answer.

These individuals work on ergonomics programs all the time and

they freely offer reports of their success.

The extent to which these claims represent hard facts as opposed

to salesmanship from people who make their living promoting

ergonomics is open to debate, but that debate is largely academic.

The question is not what employers spend on ergonomics under

the status quo, but what they would be forced to spend under a

standard that would change the status quo.

My distinguished co-panelist, David Alexander, is an articulate

and passionate proponent of the mantra that ergonomic controls

are inexpensive. He has written numerous books that promote the

cost justification of ergonomics. And he testified at the hearing that

ergonomic interventions almost always pay for themselves by ratios

approaching 10 to 1.

His views and similar opinions from two other ergonomic consultants were the sole basis for OSHA’s cost estimate. OSHA’s role,

however, is not to tell employers how to improve productivity and

save money but to protect safety and health.

If those two goals were as closely aligned as some like to claim,

then a standard would be unnecessary because employers would be

rushing to get their 10-to-1 pay backs.

But more than a decade of OSHA ergonomics activity pursued on

the advice of many of these same ergonomists, paints a very different picture. There is a reason employers are almost universally

resisting OSHA regulation. And that reason is not ignorance of economic benefits. It is the reality of what an ergonomic standard

would entail.

This stack of paper beside me, which is very high, is just a partial compilation of more than 550 ergonomic citation issued under

the so-called General Duty Clause. Each of these citations lists

measures that OSHA believed to be necessary abatements of alleged recognized hazards.

Over and over again, OSHA sought burdensome and costly job

controls such as the ones you see on the board that was just posted. When employers argued that these citations should be used as

a measure to measure a final standards cost, OSHA could not have

backpedaled any faster.

OSHA claimed that its new standard would not necessarily be

enforced in the same way, even though the standard described

what was expected in language that was basically indistinguishable

from the citations. All the while, OSHA refused to reveal exactly

what its new enforcement policy would be.

The agency also asserted that the abatements were merely recommendations. But the one employer who actually litigated in

favor of a less expensive alternative was greeted with a parade of

OSHA experts insisting on the listed measures.

The reason OSHA is so afraid of its own history is that the cost

of these measures are an entirely different universe. Many employers use these same citations to produce their own cost estimates

which added up to more than $179 billion. Taking into account the
167

1Transcript, Mar. 20, 2000, at 2183.

employers who were not even represented, the projection of more

than $100 billion in total costs is not at all unreasonable.

Now, if OSHA decides to try again, regardless of its chosen approach, it will need to do a far better job of confronting the most

fundamental question in any cost analysis.

What does the standard actually require. In the last round,

OSHA’s entire estimate of cost per job control was developed before

the proposed standard was even drafted. And that estimate was

never revisited even after major changes in the final standard.

Now, I will not repeat OSHA’s mistake of estimating a new

standards cost before I have seen the new standard. But I will tell

you that any future cost analysis must begin from a very different

base line.

PREPARED STATEMENT

OSHA should either use its own enforcement history as a guide

or should identify exactly what is different about the new approach. If the agency continues to ignore its own history, it will be

doomed to repeat it, once again producing cost estimates that seriously misrepresent reality.

[The statement follows:]

PREPARED STATEMENT OF DEAN SPARLIN

Mr. Chairman and members of the Subcommittee: We are here today to discuss

the economics of an ergonomics standard with an engineer, a health and safety director, a spine surgeon, and a lawyer. I am the lawyer, having represented clients

in occupational safety and health matters, including ergonomics, during more than

14 years of practice with Gibson, Dunn & Crutcher LLP.

The economic discussion to date has been characterized by a battle between big

numbers and mind-numbingly huge ones. OSHA told us last year that its ergonomic

standard would cost $4.5 billion per year but would save approximately twice that

amount. Employers countered with analyses showing that costs could easily exceed

$100 billion. When there is a disagreement of that magnitude, it is safe to say that

the discrepancy is more than mathematical. There is a very basic difference in vision between the two sides performing the calculations.

That, more than anything, explains why it is just as well that an economist is

not here to address these issues. Before anyone can opine on the economic impact

of a standard, there must be a clear understanding as to what the standard would

entail. The key to that question lies not in economic theory, but in a practical understanding of burdens that would be imposed in light of OSHA’s own history of enforcing similar requirements.

With all due respect, I do not believe that testimonials from ergonomists and safety and health personnel provide an appropriate perspective. It is true that these individuals work together on ergonomics programs all the time, and they freely offer

reports of their successes. The extent to which these claims represent hard facts,

as opposed to salesmanship from people who make their living promoting ergonomic

interventions, is open to debate—but that debate is largely academic. The question

before us is not what employers spend on ergonomics under the status quo, but

what they would be forced to spend under a standard that presumably would

change the status quo.

My distinguished co-panelist, David Alexander, is an articulate and passionate

proponent of the mantra that ergonomic controls are inexpensive. He has written

numerous books on the subject, including one entitled Selling Ergonomics To Management, which teaches readers how to convince skeptical bosses to sign off on

ergonomics programs. He testified at the hearing that ergonomic interventions almost always pay for themselves, by ratios that in his opinion can exceed 10 to 1.1

He supported that view with descriptions of his experience advising clients and

anecdotes he has heard from colleagues in his profession. His views, and similar
168

opinions from just two other ergonomic consultants, were the sole basis for OSHA’s

cost estimate.

It is not OSHA’s role, however, to tell employers how to improve productivity and

save money. OSHA’s role is to protect safety and health. If the agency’s safety and

health vision were as closely aligned with productivity as some like to claim, then

a standard would be unnecessary because employers would voluntarily rush to get

their 10-to-1 paybacks. But more than a decade of OSHA ergonomics activity, pursued on the advice of the same ergonomists who testified in favor of a standard,

paints a very different picture. There is a reason employers are almost universally

resisting OSHA regulation, and that reason is not ignorance of the economic benefits. It is the reality of what an ergonomics standard would entail.

The impressive stack of paper beside me is just a partial compilation of more than

550 ergonomics citations that OSHA has issued under the so-called ‘‘general duty

clause.’’ Each of these citations lists measures that OSHA believed to be necessary

abatements of alleged ‘‘recognized hazards.’’ Most of these recommendations never

show up on ergonomists’ lists of ‘‘inexpensive’’ controls. Over and over again, OSHA

compliance officers cited safety and health concerns as a justification for slowing

work pace, mandating rest breaks, adding expensive hoists or automated devices,

and micro-managing work processes.

When employers argued during the rulemaking that these citations should be

used to measure a final standard’s cost, OSHA could not have backpedaled any faster. OSHA claimed that a standard would not necessarily be enforced the same way,

even though the standard described what was expected of employers in language

that was basically indistinguishable from the citations. All the while, OSHA refused

to discuss exactly what its new enforcement policy would be. The agency also asserted that the abatements were mere recommendations from which employers

could vary. But the one employer who actually litigated in favor of a less expensive

alternative approach in response to a general duty clause citation—Pepperidge

Farm—was greeted with a parade of OSHA experts insisting that the agency’s ‘‘recommendations’’ were gospel.

The reason OSHA is so afraid of these general duty clause citations is not hard

to figure out. The costs they entail are in an entirely different universe from

OSHA’s official estimate. Abatement measures from these citations formed the essence of many employer estimates submitted during the hearings, which added up

to more than $179 billion in anticipated costs. There is some overlap in the employer estimates and some differences in their assumptions, but it is also true that

a very large portion of affected industry is not represented. It is not at all unreasonable to expect, in light of this evidence, that costs could exceed $100 billion—perhaps by a very wide margin.

Theoretically, OSHA could design a new standard or guideline—assuming appropriate scientific support—that meaningfully departs from past general duty clause

excesses. This, however, will require more than hollow assurances that enforcement

will concentrate on inexpensive remedies. Unfortunately, it is extraordinarily difficult to draft concrete limitations that would enforceably confine control obligations.

Certainly the proposed standard’s vague language does not meet this objective. Nor

does the final standard, whose ‘‘action triggers’’ and ‘‘hazard identification tools’’

serve primarily to underscore just how far OSHA expected employers to go in retooling their workplaces.

If OSHA does decide to try again, regardless of its chosen approach, it will need

to do a far better job of confronting the most fundamental question in any cost analysis: What does the standard actually require? In the last round, OSHA’s entire estimate of cost per job control was developed before the proposed standard was drafted—by individuals who afterwards could still not describe the standard’s provisions.

The estimate was never revisited, even after major changes in the final standard.

I will not repeat the mistake of estimating a new standard’s cost before I have

seen it. But I will tell you that any future cost analysis must begin from a different

baseline. OSHA should either use its own enforcement history as a guide or should

identify exactly what is different about the new approach. If the agency continues

to ignore its own history, it will be doomed to repeat it, once again producing cost

estimates that seriously misrepresent the true picture.

Senator SPECTER. Thank you very much, Mr. Sparlin. Mr. David

Alexander, certified professional ergonomist.
169

STATEMENT OF DAVID C. ALEXANDER, PRESIDENT, AUBURN ENGINEERS, INC.

Mr. ALEXANDER. Thank you very much. Good morning. I welcome

the opportunity to join the panel and share my experience on

ergonomics. My name is David Alexander. I am president of Auburn Engineers, a leading applied ergonomics consulting company.

My 25 years of private sector ergonomics experience spans a

range from small employers to the largest companies in the world.

I want to address the feasibility of ergonomic solutions and the cost

benefits of their interventions.

It has been widely stated that ergonomic problems are not solvable or that the solutions are simply too expensive. That information is wrong. With 25 years of professional experience, I have yet

to see a job that could not be improved with the application of ergonomic principles.

I personally developed thousands of solutions to ergonomic problems and my colleagues have told me of many more. The solutions

range from simple workplace changes to complex factory redesigns.

For window and door manufacture I was able to reduce ergonomic

risk factors by 90 percent while increasing productivity by 300 percent. For chemical manufacture I was able to reduce ergonomic

risks by 80 percent while increasing productivity by 50 percent. For

an auto components manufacture I reduced loss time by 80 percent

while saving a million dollars in operating cost. For a telecommunications company, reduced lost time cases by 80 percent and demonstrated productivity savings as high as 15 percent. These ergonomic projects, while notable, are not uncommon. Similar results

have been reported by other practicing ergonomists.

The practice of ergonomics is not limited to experts, however.

Many organizations are using employee teams to resolve problems

and necessarily this drives the cost down rapidly. Fifty percent of

ergonomic problems in my opinion can be solved locally using local

resources and local workers and their supervisors.

Many trade associations have developed solution databases for

ergonomic problems. They’ve shared these widely. I’ve participated

and worked with those in textiles, apparel, food distribution, paper

chemicals, petroleum, and I know other industries have done the

same.

These guidelines get passed from plant to plant. They become

more refined, they become more effective and they become cheaper

to implement, thus some of the cost from yesteryear do not reflect

the cost of tomorrow.

There are thousands and thousands of good examples of interventions out there. OSHA has developed lists of these and shared

them, as have insurance companies and many universities. In summary, I find that ergonomic problems are typically easy to identify

and rarely require sophisticated techniques to resolve. I have a promotional poster, if I could put that up, that illustrates a simple

case of ergonomics. It involves some visiting dignitaries we White

House during the last Bush administration as a story. Could you

put the—it is a cartoon poster, I am sorry.

As the story unfolds, several shorter dignitaries have difficulty

speaking from a podium adjusted for a much taller President Bush.

After several near falls, this team of ergonauts uses our simple
170

problem solving process to develop a cost-effective solution to the

problem. As the story illustrates, ergonomics works.

Now, let me turn to the topic the cost benefits. Cost of a dollar

spent to implement solutions, benefits were the savings that the organization achieves. The benefits are attained by controlling worker injuries and saving the dollars currently being lost from medical

treatment, workers compensation, lost time, replacement workers,

overtime, lost production, reduced quality.

All of these have benefits or a number of these have been outlined by OSHA. But that is not the whole story. There are substantial benefits which are not reflected by the OSHA cost calculations.

These are the business level improvements that typically result

from ergonomic projects. Mr. Sparlin referred to these.

Here gains can be made that increase the operating performance

above baseline performance and these are substantial, in some

cases approaching ten times the cost. A common problem with cost

calculations is under-reporting. People do not do a good job. Common problem with benefits is under-reporting. We do not calculate

those well. In one case in the printing industry we were able to

document ten times more benefits than what had been initially perceived.

Project costs are frequently inflated. Overdesign is a common

problem with an emerging industry and that is what it is with

ergonomics. As we gain more experience, cost go down. I also find

that some industries have not modernized. They are using out of

date processes and unfortunately they lump the cost of modernization along with the cost of ergonomic compliance, thus grossly inflating prices.

PREPARED STATEMENT

When we look at ergonomics, we have to recognize that costs will

drop as experience goes on. I’ve chaired in a flight ergonomics——

Senator SPECTER. Mr. Alexander, your time is up. If you would

summarize your full statement, it will be made a part of the record.

Mr. ALEXANDER. Thank you very much. Ergonomics works. Good

ergonomics is good business.

[The statement follows:]

PREPARED STATEMENT OF DAVID C. ALEXANDER

CREDENTIALS AND QUALIFICATIONS

Good morning. My name is David Alexander. I have been practicing ergonomics

in the private sector for over a quarter of a century. I hold two degrees in engineering, the second a Masters degree with a specialty in ergonomics. I have continued

my professional development throughout my career with extensive academic work,

short courses, conferences, peer discussions, and professional exchanges.

I am licensed to practice engineering as a registered Professional Engineer in Alabama and Tennessee, and have been for more than two decades. Furthermore, I

have authored many questions on ergonomics used to test professional engineering

candidates. The exam is required for registration as a Professional Engineer.

I am a Certified Professional Ergonomist, and have been for many years. For the

past 4 years, I have served as an officer on and member of the Board of Certification

in Professional Ergonomics (BCPE). I assist with the CPE test development process,

and have worked to increase the number of Certified Professional Ergonomists in

the United States and the world. I am currently Vice-President of BCPE.

My peers in the field of industrial ergonomics have recognized me as one of their

outstanding practitioners. I received the Ergonomics Award from the IIE in 1986.

I was awarded Fellow status in the Institute of Industrial Engineers in 1990. I re-
171

ceived the Industrial Ergonomics Award from the Industrial Ergonomics Technical

Group of the Human Factors and Ergonomics Society in 1993. I am the only

ergonomics professional to be recognized by both of these two leading professional

societies.

I hold two patents for the design of ergonomics inventions. The first is a revolutionary new tool handle design, and the second is for an ergonomically designed

piece of equipment used for decorating cakes and other baked goods.

I speak routinely on ergonomics and its application in industry. I have been invited to speak for groups in engineering, health care, safety, health, legal and all

other professions related to ergonomics. My presentations have included invited keynote speeches as well of papers, workshops and tutorials. I have taught thousands

of people my techniques and practices.

Currently, I am President of Auburn Engineers, Inc., an ergonomics consulting

company. I have many Fortune 100 companies as clients. My staff and I provide a

wide range of ergonomics services and have since 1988. During my tenure in

ergonomics, I have worked with many organizations, both large and small, representing many different industries. I have worked with labor unions and with management, with safety and health professionals, with engineers and health care practitioners, with production workers and their supervision.

Prior to my work with Auburn Engineers, Inc., I was an engineer, an ergonomist,

and an ergonomics program manager for Eastman Kodak Company, and performed

hundreds of ergonomics projects in all facets of their operations.

During my quarter century of professional ergonomics practice, I have worked in

many different industries. A listing of recent clients includes: Chemicals, Forest

Products, Petroleum, Food Production, Health Care, Medical Equipment, Hospitality, Government, Food Service, Electronics, Plastics, Aerospace, Paper and Pulp,

Metals Refining, Distribution and Delivery, Printing, Auto Assembly, Metal Processing, Consumer Products, Telecommunications, Missiles and Space, Textiles, Apparel, Appliances, Auto Parts, and Mining. Over the years, I have worked with more

industries, provided training for their staffs, visited and toured others, and have

spoken with ergonomists and engineers from yet even more.

DOES ERGONOMICS WORK?

During my years of experience with ergonomics, I have yet to find a job that cannot be improved with the application of ergonomics principles. I would like to share

some examples of the outcomes of ergonomics when it is applied in business:

—This company builds automotive equipment for a major auto assembly manufacturer. It must provide components in a just-in-time environment to an assembly

plant a few miles away. We were initially identified as a source of assistance

by a state agency whose mission it is to help state manufacturers that are in

distress or are having significant problems with productivity, environment, safety or other major issues. This company employs approximately 300 people at

this site. When we were first introduced to this company, they told us that their

injury rate was overwhelming, that their costs from these injuries were approaching $1,000,000 annually, and that they felt an OSHA citation was possible since OSHA was investigating other issues at the plant. We worked collaboratively with them to plan, then implement, an effective ergonomics program. The work included identification of jobs with risks, development and implementation of engineering and administrative controls, training, and the use

of job hazard analysis for all jobs. Within a 6-month period, there was an 83-

percent reduction in workers compensation costs, and a drop in the OSHA recordable rate from over 50 to less than 4. There was also a 100-percent placement of workers with restrictions into normal production jobs with no ‘‘make

work’’ jobs being performed. This company was recently awarded the PACE

award in the automotive industry for innovation management practice. So not

only have they made substantial gains in business performance, they have been

recognized by their peers for this accomplishment and the way in which it was

made.

—This company produces wood products in the mid-West, and had a significant

ergonomics problem. We helped reduce their compensation costs from over

$720,000 per year to $25,000 per year, and dropped their injury rate from 180

per year to less than 5 per year. We did this with a combination of engineering

and administrative controls, training, management support, and other

ergonomics program measures.

—This company produces pre-hung doors and windows. It was experiencing excessive back injuries from manually handling the doors and from poor work positions. We reviewed their jobs, and developed a number of job enhancements in-
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cluding supported tools, better work tables, guides and fixtures, and a new conveyor line. When we were done, the result was a 300 percent increase in productivity and a 90-percent reduction in ergonomics risk. The plant was now able

to produce 900 doors rather than 300 doors per shift with no additional personnel.

—On a chemical bag filling operation, we were asked to provide improvements for

a bag filling and sealing operation. We did a careful analysis and made recommendations that permitted a 50-percent increase in productivity along with

an 82-percent reduction in ergonomics risk. The number of bags that could be

filled went from 960 per shift to 1,400. The changes included an alternate method of moving bags on a conveyor, changing work heights, and altering the methods of feeding bags into a heat sealer.

I share these with you because they make the point I wish to leave with you—

Ergonomics works!

There are hundreds and thousands of successful ergonomics interventions out

there. Ergonomics works, and works well. These successes range from simple

changes to work methods to complete reorganizations of factories and workplaces.

Many of these successes can be found by talking with practitioners in industry and

business, or by reviewing the many case studies found in the scientific and trade

press publications.

WHAT ARE THE TANGIBLE BENEFITS TO THE APPLICATION OF ERGONOMICS?

To answer this question, it is helpful to understand the types of benefits one can

expect from ergonomics applications. They fall into several categories: avoided costs,

and performance improvements.

Avoided costs begin with the avoidance of direct injury/illness costs by controlling

or eliminating the injury/illness. As this occurs, then one also avoids the indirect

costs of injury/illness such as replacement workers, the manufacture of off-quality

products, time for the investigation of incidents, implementation of necessary corrective actions, and so on. Essentially these are unplanned losses, or costs, or expenses,

which take profits away from the bottom line of the organization.

Besides avoiding losses, there is a great opportunity to achieve performance improvements. Performance improvements occur when ergonomics improvements permit one to achieve breakthrough performance that exceeds the current baseline.

These improvements are most often reflected as traditional business measurements

such as enhanced productivity, less downtime, product quality, delivery, fewer bottlenecks, and so on. They may also include lower costs for workers’ training or employment as jobs become less stressful. The best way to think of these items is that

they improve upon your expected level of operation and permit you to operate better

than planned. The result is increased profits to the business.

Ergonomics benefits are measured in at least 17 different ways, according to my

research, but one of the most common is benefit/cost ratios. These calculate a ratio

of the benefits associated with an ergonomics project relative to the costs required

for implementing the project. The benefit/cost ratio should be greater than 1.0 for

an economical, value added project. The benefit/cost ratio can be impacted in two

ways: one, increase the level of benefits for the project, or, two, decreases the costs

associated with the project.

The benefits can be increased by identifying and reporting more benefits (a common problem with cost justification is that economic benefits are chronically underreported). The costs can be reduced by lowering the cost of the project, perhaps by

using administrative controls or with less sophisticated engineering controls.

The cost of ergonomics projects is highly variable. Solutions range from low cost

administrative controls (work methods, job redesign) to very expensive mechanical

equipment. Often, for a single set of risk factors, as many as 5–10 different solutions

can be developed and implemented. The choice of the solution has a great impact

on the overall cost of the project. For many projects that report high costs, the problem is that an overly expensive solution has been chosen, when in fact, a lower cost

solution would work just as well.

In my work, I found that about half of the ergonomics projects cost less than $500,

and can be done on a standard work order without the need for detailed justification. And only a third of the projects cost more than $1,000. In other words, an

ergonomics project is likely (two times out of three) to cost less than $1,000, and

usually can fit within most operating budgets. Hugh budgets for the implementation

of widely expensive ergonomics program simply do not occur.

At the request of one of our clients, we examined these benefits with the goal of

developing ‘‘multipliers’’ which could be used to determine the value of the benefits

relative to workers compensation costs. For ergonomics, the benefits multiplier was
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found to be from 0.5 to 2.0 for the ratio of direct to indirect costs. We also looked

at the benefits attained from improved performance, and found them to be very

large. This multiplier was found to range from 2 to 10 times the cost of workers

compensation.

One real opportunity, and one that is commonly overlooked, is the savings that

can occur from better design practices. We have measured the costs associated with

design for ergonomics, and find them to be a highly attractive investment. In fact,

this is how we characterize these costs. They are an investment in the design, which

should provide a payback later on. The cost of design goes up substantially as the

project progresses. The difference between ‘‘doing it right the first time’’ at the initial design stage and waiting until injuries occur during normal operations, is tenfold. The costs will be ten times higher when retrofits are utilized rather than having ergonomics designed in from the start. Similar figures have been reported by

others practitioners, especially those in the auto industry. What this means is that

costs for ergonomics interventions for current operations cannot and should not be

extrapolated into the future. When workplaces, tools, equipment, vehicles, assembly

lines, and factories are designed properly from the start, the ergonomics costs

should be one-tenth of the current estimates.

TRENDS IN APPLIED ERGONOMICS

I founded the Applied Ergonomics Conference Series and last month we held our

4th Annual Conference, with almost 800 people in attendance. They represented industry and business from virtually every employment sector, as well as organized

labor, trade and professional groups, and government. We heard 100 presentations

on ergonomics programs and interventions.

There is widespread use of ergonomics in the private sector for both injury/illness

control and business performance improvements. During the four conferences I have

chaired since 1998, we have had some 300 presentations on successful applications

of ergonomics, dozens of workshops and seminars, and keynote speakers from industry, labor and government. Many of these presentations are documented in our

printed volumes of ergonomics case studies, and more recently in electronic form on

the internet.

And we have had 2,500 attendees representing virtually every state in the union,

our NAFTA partners Mexico and Canada, and a number of European countries. The

attendees represent 500 companies, universities and Federal and State governments.

The Applied Ergonomics Conferences have been sponsored by a diverse list of professional organizations and agencies including:

—Institute of Industrial Engineers

—Department of Labor Occupational Health & Safety Administration

—National Institute for Occupational Safety and Health

—American Association of Occupational Health Nurses

—American Industrial Hygiene Association

—American Society of Safety Engineers

—Association of Canadian Ergonomists/L’Association Canadienne d’Ergonomie

(ACE)

—Board of Certified Safety Professionals

—Board of Certification in Professional Ergonomics

—Ergonomic Assist Systems and Equipment—a product council of Material Handling Industry of America

—International Labour Organization

—Risk and Insurance Management Society

—Society for Risk Analysis

—Society for Work Science

—Voluntary Protection Programs Participants’ Association

At these conferences, I have been able to listen to many presentations and to talk

with dozens of participants about their on-going work on ergonomics. I found the

following trends:

—Ergonomics is being applied in increasingly diverse settings. We have examples

of ergonomics in food distribution, health care, government, petroleum,

meatpacking, retail, construction, agriculture, distribution, and other industries.

—More and more people are involved with the application of ergonomics. We have

many examples of shop-floor teams, most including supervision or staff, but

some with just production workers. There is normally involvement with nurses

and health care providers for root cause determination, and with maintenance

and engineering for equipment alteration.
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—There are many examples of shop floor improvements leading to injury/illness

reduction and to productivity and quality improvements. Most teams will report

benefits for both safety and health, and for productivity or quality.

—Training is becoming more commonplace and less burdensome. Some teams develop skills with a few hours of training, and then are ready to develop and implement successful ergonomics improvements.

—There is extensive sharing of solution ideas. This sharing is occurring within

companies, within industries, and even across industry sectors.

—There is a clear trend toward the use of design to prevent problems rather than

just to fix problems. Several major auto manufacturer touted their successful

work in the design of manufacturing cells, production lines, and even in vehicle

design in order to prevent ergonomics injuries and illnesses before they occur.

A couple of important points about this:

—They use risk factors as their guide, not injuries. This indicates a high level

of maturity with the surveillance and ergonomics problem identification part

of their programs.

—They do this design work for business reasons. Ergonomics is good business,

and it is economical to spend millions of dollars in this way. For a new model

change-over, the costs may run into the millions of dollars, yet create savings

equal to 10 times that number.

—They report that the majority of these changes result in other positive business improvements like productivity (77 percent of the time), quality (50 percent of the time) and reduced vehicle weight (10–15 percent of the time).

—Many who originally opposed ergonomics now support it! There are many examples of companies who came to learn about ergonomics from an OSHA citation,

but who now tout its benefits. Originally, they bemoaned ergonomics as a burden to their business and unnecessary for the protection of their workers. How

time and experience can dramatically alter one’s viewpoint.

IF YOU GO FORWARD

I have worked with industry for many years, and I find that ergonomics programs

are more effective when they include the following:

—Involve employees in solving ergonomics problems. Ergonomics solutions are not

usually difficult to identify. In my experience, 50 percent can be handled at the

worker/supervisor level, and most of the others are resolved with an in-plant

team.

—Use trade groups, sister plants and other organizations to both identify and resolve ergonomics problems.

—Have a sound health care program and treat injuries both quickly and with respect.

—Have management leadership on ergonomics, just like it provides leadership on

safety, health, production and quality issues.

—Provide training where necessary to ensure effective performance. JHAs are

necessary in modern industry.

—Prevent ergonomics problems by reviewing new jobs, tools, and equipment.

—Review the ergonomics program to ensure its effectiveness.

There are clear differences between effective programs and ineffective ones. Effective programs contain certain elements and work in certain ways.

IN CLOSING

Finally, in closing, let me say that ergonomics is tool that is already used in industry. It is not a new tool, it is not difficult to use, and it is not burdensome. It

is part of continuous improvement programs used in many organizations to improve

safety and health, quality, productivity, and cost.

Thank you for your attention. I look forward to providing additional clarification

with your questions and on-going deliberation on ergonomics.

Senator SPECTER. Thank you. We turn now to Mr. Eric Frumin,

director of Safety and Health, Union of Needle Trades, Industrial

and Textile Employees Mr. Frumin.
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STATEMENT OF ERIC FRUMIN, DIRECTOR, SAFETY AND HEALTH,

UNION OF NEEDLE TRADES INDUSTRIAL AND TEXTILE EMPLOYEES

Mr. FRUMIN. Good morning, Senator. First I just want to submit

for the record a slightly corrected version of the written testimony

I submitted.

Senator SPECTER. It will be made a part of the record in full.

My name is Eric Frumin. I am the health and safety director of

UNITE. On behalf of our members in Pennsylvania and Philadelphia and throughout the Nation, we very much appreciate the opportunity to testify here today.

The arguments about costs and benefits have generated much

sound and fury and from some quarters like Mr. Alexander, actual

enlightenment. From other quarters, however, there’s been nothing

but fury and active disinformation. Today UNITE is confident in

stating the following. First, the cost of these injuries are huge to

employers, workers and taxpayers alike.

Second, the requirements of the OSHA ergonomic standard are

eminently feasible. The potential cost of those requirements are

sensible in business investments, and the benefits of ergonomic

programs to workers, employers and society are substantial.

The arguments you have heard today and before about the feasibility, costs and benefits have degenerated into a virtual warfare

and as the saying goes, the first casualty of war is the truth. It is

been obstructed, the argument, has by what we would call a big lie

campaign orchestrated by the most rabid opponents of reasonable

worker safety rules who misled and frightened employers large and

small.

The Stanley company, as you know, is one of the nations largest

makers of tools. Their sales of ergonomically designed tools depend

heavily on employer confidence that ergonomics works. But as one

of their senior managers told Business Week magazine, we’re competing against ignorance. How much do these injuries cost? As Dr.

Barondess pointed out, between $45 and $54 billion annually,

about 1 percent of the gross domestic product.

The cost of these injuries is the very reason why this Congress

passed the Occupational Safety and Health Act. But actual industrial experience shows that ergonomics programs are technically

feasible and are cost-effective and I want to take you, Senator, to

Lewistown, Pennsylvania to the Leer Corporation.

Repeatedly before both the Senate Labor Committee and the

OSHA rulemaking record local union officers have testified about

the OSHA citation at that plant, about the benefits of the

ergonomics program which the management implemented as a result of that citation. That citation and the program the employer

implemented did exactly the same things that Mr. Sparlin is listing

on his chart here this morning and I am curious why Mr. Sparlin

hasn’t pointed to the Leer Corporation. That company came out

strongly in support of OSHA enforcement of the general duty

clause and we know that that ergonomic injuries in that plant have

been seriously reduced to virtually no disabling injuries anymore in

that plant. And Senator, we would invite you to come and visit that

plant.
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The auto parts industry is highly competitive. Good jobs like this

in central Pennsylvania are not easy to find. But the management

and these workers have nothing to fear from ergonomics and everything to gain.

The OSHA rulemaking record is replete with examples like this

from large and small employers alike. The Xerox Corporation submitted, Mr. Senator, a formal cost benefit analysis to the OSHA

rulemaking record. They spent $3.4 million on the ergonomics program in 1999. They said the resulting savings was $7 million in

that year for avoided workers compensation claims. These kinds of

benefits are achievable throughout the economy and OSHA reviewed hundreds of studies and scientific evaluations and case

studies which came to the same conclusion.

Senator SPECTER. What company was the last one you referred

to?

Mr. FRUMIN. Xerox Corporation and that is in my prepared statement.

Unfortunately, Senator, with rare exception it appears that these

and other well-meaning companies were not present at the OSHA

hearing. They did not show up to testify. You’ve heard about the

auto companies. Where were the Big Three companies at the OSHA

hearings. Where were the individual grocery chains, where were

the nursing homes? Seems like they were all in hiding to avoid admitting the truth about their actual investments in ergonomics and

the returns that they enjoyed.

What OSHA did here instead largely with speculation about possible compliance problems but the testimony of one participant was

most revealing, the United Parcel Service, the single most active

employer never showed up at the hearing to testify. None of their

managers came. Only later did OSHA receive a corporate memo

from UPS, UPS corporate memo, March 10th, the year 2000, from

the corporate industrial engineering department entitled Ergonomic Endeavors clearly identifies the capital investments and operating investments they’ve made to improve the ergonomics in

their work force.

Never once did any of their representatives at that hearing provide this kind of information to OSHA or identify the cost that—

the investments that UPS was making or the savings that UPS

was enjoying. Why? We cannot answer for them. Maybe they can

answer for themselves. But the real question to UPS and to the

other employers who have opposed this in the way that they have,

what are you now spending on it? Why don’t you tell us what the

truth is, how much are you saving and why are you making these

investments.

PREPARED STATEMENT

Senator SPECTER. Mr. Frumin, your time has expired, your full

statement will be made a part of the record so if you would now

summarize, please.

Mr. FRUMIN. We have heard, and as Congress unfortunately has

heard, a figure of $120 billion as the cost of this standard. We reject that as a total fabrication. We call upon the Congress to look

at the findings of previous OSHA rulemaking such as the OTA, the

Congressional Office of Technology Assessment has shown OSHA’s
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rulemakings to be feasible, to be economically achievable and we

urge the Congress to immediately compel the Secretary to issue a

new standard forthwith. Thank you very much.

[The statement follows:]

PREPARED STATEMENT OF ERIC FRUMIN

Good morning. Mr. Chairman, members of the Committee, my name is Eric

Frumin. I am Health and Safety Director of the UNITE. I am also the chairman

of the Advisory Committee on Occupational Safety and Health Statistics to the U.S.

Bureau of Labor Statistics, and a member of the Board of Scientific Counselors to

NIOSH.

I am here to address several key questions regarding the OSHA standard on

ergonomics:

—the actual feasibility of the standard’s requirements

—potential costs of those requirements, and

—likely benefits to employers, workers and society.

THE FIRST CASUALTY OF WAR IS THE TRUTH

I want to state initially, however, that as with the so-called debate about the underlying science of ergonomics, the discussion of feasibility, costs and benefits has

been obstructed by a Big Lie campaign. This campaign was orchestrated by the

most rabid opponents of reasonable worker safety rules, who misled and frightened

employers large and small with their fabrications. This of course contributed to the

misinformation feeding the Congressional debate earlier this year, and adds another

unfortunate chapter at today’s hearing.

This campaign of lies and distortion is truly shameful. Not only has it irreparably

harmed OSHA’s ability to issue cost-effective standards to prevent the biggest jobsafety problem in the American economy. It has also sowed confusion and fear of

essential preventive activities in the minds of America’s managers and workers—

the very people who must understand clearly that ergonomics works, that

ergonomics both protects workers and saves money for employers and workers alike.

ACTUAL INDUSTRIAL EXPERIENCE SHOWS THAT ERGONOMICS PROGRAMS ARE

TECHNICALLY FEASIBLE AND ARE COST-EFFECTIVE

On June 21, 1995, President Rick Treaster of UNITE Local Union 2400 from

Lewistown, PA, testified before the Senate Committee on Labor and Human Resources. About OSHA’s intervention at his plant—the Masland Co. auto carpet plant

in (now owned by the Lear Corp.), which employs 200 workers. Mr. Treaster described in detail how OSHA’s strict enforcement of the general duty clause for ergonomic hazards accomplished two things: first, it helped both the management and

the workers focus on real solutions to a serious safety problem. And second, it

prompted the company and the union to work together on new joint efforts to improve wages, quality and productivity. At that hearing, the management wrote to

Chairman Kassebaum stressing its strong support for strict enforcement of OSHA

rules.

Attached to my testimony are the actual numbers of worker injuries at the

Lewistown, PA plant as of 1995.

During the OSHA rulemaking hearing on the proposed standard, Rick’s successor

Greg Wakefield testified again about the continuing success of the ergonomics program in the plant. Wakefield reported, as was confirmed by the management, that

serious ergonomically-related injuries had been virtually eliminated in the plant due

to an aggressive comprehensive program which virtually mirrored the core elements

of the OSHA standard: worker education, early reporting, job interventions and

when needed intensive job and equipment redesign. This resulted in substantially

lower costs to the company, which accompanied substantial boosts in productivity

and quality. The auto parts supply industry is highly competitive, and good jobs like

these in central Pennsylvania are not easy to find. But this management, and these

workers, have nothing to fear from ergonomics, and everything to gain.

Mr. Chairman, as is revealed in both OSHA’s final standard and the testimony

today of Dr. David Alexander, the OSHA rulemaking record is replete with similar

examples from large and small companies alike.

One company—Xerox Corp.—actually submitted a formal cost-benefit analyses regarding its ergonomics program (Exh.#30–1963). According to Xerox, their total

1999 ergonomics program investment of $3.4 million yielded a
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‘‘. . . resulting benefit . . . of more than a $7 million reduction in the annual

cost of ergonomic-related workers compensation claims from the 1992 peak.’’

In other words, it shows that a corporate ergonomics program is a net cost-savings

measure when accounting even if one relies solely on workers compensation costs.

Moreover, such an analysis does not begin to take into account the many other ergorelated cost types (such as other disability and Human Resource costs, reduced productivity from poor job design, limited quality due to bad job engineering, etc.).

A few other industry groups, such as the textile and apparel industry associations,

acknowledged that ergonomics programs were cost-effective and a necessary part of

a competitive business strategy in today’s economy.

Indeed, whenever anyone has looked seriously at actual industrial experience with

ergonomic principles and interventions, for those few cases of failure or frustration

there are many more cases of clear and cost-effective success.

This includes the hundreds of detailed case studies reported previously by corporate personnel, OSHA, NIOSH, labor unions and ergonomics consultants. Others

were performed directly by OSHA’s expert witnesses, including Dr. Alexander and

others. These reports and studies were done at the most recognizable names in

American industry: General Motors, Ford and Chrysler; Compaq Computer Co.; Allied Signal, Coca-Cola, Kellogg Foods, Nabisco, Proctor and Gamble, Scott Paper,

and literally hundreds of other companies large and small.

Not surprisingly, in its Final Economic Analysis, OSHA specifically cited 7 examples from the rulemaking record of well-documented, cost-effective comprehensive

ergonomics programs, including, Dow Chemical, Consolidated Edison, US Defense

Department, and Levi Strauss, in addition to the company-specific programs in both

large and small businesses provided by three labor unions in the auto, food and apparel sectors.

OSHA also cited in its Final Economic Analysis the large number of both scientifically-designed evaluations of ergonomic interventions and individual ‘‘case studies’’

on specific workplaces or occupations, some of which clearly identified the employers

in question.

Some of the same hundreds of companies which were also undoubtedly included

in the last-minute, biased survey by the Employment Policy Foundation (EPF). This

so-called claimed to indicate that the annual costs to employers would approach

$120 billion. Notwithstanding the fact that this ridiculous estimate was submitted

too late to be subject to serious critical evaluation by OSHA or anyone else, it is

instructive how vastly different are the EPF estimates from those of the real-world

experiences of America’s employers and workers.

Indeed, what surprised many observers at OSHA’s hearing last year was the utter

absence of significant reports of actual ‘‘bad’’ employer experience with ergonomics

program, especially from the multiple companies which had implemented

ergonomics programs in the past.

Unfortunately, with rare exception, it appeared that these otherwise well-meaning

employers—companies which knew that ergonomics works and saves money—were

avoiding the OSHA hearing like the plague.

Where were the representatives from the Big Three auto companies who had invested millions of dollars in ergonomics program far beyond anything OSHA had required in its ergonomic citations?

Where were the individual grocery chains who had already spent millions on improved checkstands?

Where were the nursing homes chains which are grappling with unsupportable

workers compensation costs and turnover rates because of the epidemic of disabling

back injuries among nurses aides?

They were all in hiding. We can only assume that they were avoiding the prospect

of embarrassing or frankly undermining their customers or the know-nothing companies in the same industries. It seems they had to avoid admitting the truth about

their actual investments in ergonomics activities, and about the returns they enjoyed on those investments through the reduced costs for workers compensation or

the improved productivity of their operations.

Those skeptical or pessimistic estimates which OSHA did hear, instead, was almost exclusively speculation about possible compliance problems. Much of this speculation came from companies which had not made serious efforts to prevent ergonomic injuries among their employees. And given the campaign of fear which emanated from the National Association of Manufacturers and Chamber of Commerce,

it is not surprising that the uninformed would attack ergonomics programs in this

way.

But the testimony of one participant was most revealing. Judging by the number

of lawyers present at any moment, the United Parcel Service was the single most
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active participant in the entire rulemaking. They initially requested an opportunity

for over 20 witnesses to appear. Most were supposedly independent medical personnel, but several UPS managers were included. However, when UPS’ turn came,

almost all their witnesses disappeared, including all participation by their corporate

managers.

Only later did OSHA receive—from the Teamsters union—the actual evidence of

UPS’ views on the feasibility of ergonomics programs. Attached to my testimony is

the March 10, 2000 internal UPS memorandum from the Corporate Industrial Engineering Department entitled ‘‘Ergonomic Endeavors’’. This memo clearly identifies

substantial capital and operating investments which UPS has made to implement

an ergonomics program throughout the company. It reveals that UPS has invested

significantly in new trucks, ergonomic tools for drivers, new warehouse equipment,

new computer software and hardware, new office equipment and extensive training

of management personnel.

This is the company which claims there is no science underlying ergonomics, but

that under the heading ‘‘Comprehensive Self Evaluation’’ apparently has ‘‘trained

over 500 UPS people (including some hourly) in ergonomic principles . . .’’

This is the company that claims that ergonomics interventions do not prevent lifting-related injuries, but that under the heading ‘‘Ergonomics Awareness’’ had run

‘‘over 20 workshops . . . at districts, regions across the country to convey importance of ergonomic principles, job set-up and methods, and workplace design. . . .’’

Mr. Chairman, UPS’ lawyers attended the OSHA hearing virtually day, and never

once did they give OSHA any inkling of the extensive nature of UPS’ activities on

ergonomics. Never once did they admit to UPS having spent significant corporate

resources to established an ergonomics program. Never did they offer an actual UPS

manager with the authority to speak or answer questions about the company’s engineering investments in labor-saving equipment or the savings which UPS enjoyed

from that investment.

It is easy to understand why: because if UPS managers had revealed officially the

company’s activities comparable to the very same measures included in the proposed

standard, OSHA or someone else might have challenged them to say how UPS ever

justified that investment. What were the costs of the injuries that these investments

were designed to prevent? How large was the company’s savings by the avoidance

of these costs? And how much more did the company save in productivity improvements as a result of these investments?

$120 BILLION: A FIGURE VIRTUALLY FROM THIN AIR

Mr. Chairman, those questions linger today even as the Employment Policy Foundation’s phony $120 billion cost figure continues to reverberate around the Congress

and throughout the media.

We completely reject this absurd, trumped-up fabrication. Notwithstanding their

complaints about OSHA’s rush to judgment, EPF and their presumptive allies at the

NAM and UPS waited until March 2000 to begin to collect data about employers’

costs of compliance. They did not make any of their data available until June 26,

well after their witnesses appeared at OSHA’s actual hearing to answer questions.

They then reported the summary version of their actual economic estimates on August 9, including their reference to their computer modeling which generated the infamous $129.5 billion first-year cost figure.

This estimate purportedly relies on survey data from an unspecific number of Fortune 500 companies with about 1.7 million workers in nearly 20,000 separate establishments (averaging over 500 establishments per company).

However, despite that extensive direct line of communication with the largest corporate entities in the entire world, the EPF survey did not identify the actual compliance costs for a single specific high-risk job or operation. Not for a single truck

driver, or grocery warehouse or retail checkstand, or nursing home, or paint booth,

or parts assembler.

Furthermore, their survey itself was not submitted for the record, only portions

of it dealing with the employers’ estimates of time allotments. And the actual methodology for the conduct of the survey was never revealed—only the summary results.

(At the same time, they acknowledged that the benefits would be significant—albeit less than OSHA estimated in the proposed rule. But they failed utterly to provide any accounting of the derivation of the benefits, nor to report the experiences

of individual employers regarding the returns on ergonomic investments which such

employers have enjoyed.)

We may contrast this with the extensive and detailed examination which OSHA

gave to specific industry sectors in both the proposed and final standards, as re-
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quired by the OSH Act and the Regulatory Flexibility Act. OSHA made multiple

analyses to confirm the legitimacy of its approach. OSHA ultimately derived a costestimate which began with job-specific estimates covering nearly half the reported

MSD’s in the entire economy. In addition, OSHA dealt specifically in the final

standard with the criticisms of its opponents, including UPS and EPF, regarding

OSHA’s cost estimates for individual jobs or operations.

All of this analysis would be reviewable by the Court of Appeals. As in the past,

OSHA’s opponents would have detailed opportunities to challenge OSHA’s methods

and conclusions, and request a stay of the proceedings if needed.

But OSHA’s opponents had no sincere interest in legitimate analysis or discussion. Their only interest, it is now evident, was to quash any real evaluation of the

facts about workplace injury or effective job safety investments, and destroy OSHA’s

ability to ever regulate these hazards.

HISTORY OF INDUSTRY MISREPRESENTATIONS ABOUT COSTS

But this is by no means the first time that an industry coalition or trade association has sought to undermine the basic functioning of the Occupational Safety and

Health Act by vastly overestimating the potential technological or economic problems of compliance with a proposed OSHA standard. Virtually every time that

OSHA has proposed to substantially improve worker, the affected industries have

cried wolf about the supposed costs, and threatened to close up shop. And time after

time, the actual costs have been within OSHA’s estimate—or indeed far less.

In 1995, the Congressional Office of Technology Assessment reviewed this sordid

history of industry obstructionism, and tried to identify the actual costs. OTA, no

captive of the labor unions or environmental activists, concluded, among other

things:

1. The agency’s findings and estimates on hazard control options and regulatory

impacts are often the subject of vigorous review and challenge by stakeholders and

various experts on all sides of rulemaking issues. But this reaction does not generally indicate underlying agency analytical neglect. The agency’s rulemakings are

often lightning rods for controversy and are conducted in a politically polarized setting.

2. The agency’s findings and estimates on hazard has generally performed this

task with workable accuracy—that is, standards determined by OSHA to be ‘‘feasible’’ in the course of its analytical deliberations have usually proved to be so when

industries took the necessary steps to comply. Nonetheless, the agency’s demonstrations of feasibility are often based on conservative assumptions about what compliance responses will predominate across affected industries. As a result, there are

often sizable disparities between OSHA’s rulemaking projections of control technology adoption patterns, compliance spending, and other economic impacts, and

what actually happens when affected industries respond to an enacted standard. In

a good number of the cases that OTA examined, the actual compliance response that

was observed included advanced or innovative control measures that had not been

emphasized in the rulemaking analyses, and the actual cost burden proved to be

considerably less than what OSHA had estimated.

3. . . . OSHA’s rulemakings are not generally imposing unworkable compliance

burden on industry. In six of the eight cases considered industry stakeholders and

their representatives argued in the course of the rulemaking (modestly to vigorously, depending on the case) that compliance would pose unworkable problems....

For the most part, the post-promulgation reality observed in this project’s case

study standards proved much the opposite of these representations. [footnote omitted] In almost all these cases . . ., the industries that were most affected achieved

compliance straightforwardly, and largely avoided the destructive economic effects

invoked by their rulemaking arguments. Very few companies left the industry chiefly because of the new compliance requirements. And, in a good many of the cases,

the actual cost burden of compliance proved considerably less than OSHA’s final estimate—about one-quarter the estimate in Vinyl Chloride, one-third in Cotton Dust,

and one-half in Formaldehyde (metal foundries). Furthermore, in half of the eight

cases examined, the standard stimulated changes in the production technology of affected industries that yielded benefits beyond a means for health and safety hazard

compliance.

In Vinyl Chloride, several of the principal industry members capitalized on the

altered business and regulatory setting to commercialize innovative processes for

polyvinyl chloride polymerization, which enhanced manufacturing productivity, better rationalization of material inputs, largely eliminated the need for manual reac-
181

tor cleaning (a prime source of high exposures for the workforce), and provided a

new source of income to the technology’s developers through licensing arrangements.

In Cotton Dust, OSHA’s mandate for greater dust control, combined with a strong

need for more competitive production capacity, drove much of the textile industry

to accelerate investments in modern production equipment—this modernization

yielded improvements in manufacturing productivity and product quality while providing a more cost-effective means to bring dust levels within the terms of compliance. Other aspects of this persistent problem are described in the attached analysis of

the OTA report from the New York Times.

We have witnessed this year probably the most catastrophic example of this unscrupulous behavior. It remains up to the Congress heed the conclusions of the Office of Technology Assessment, and to set the record straight: OSHA’s work has benefited the American people, and deserves our support even in the face of an

hysterical political juggernaut like that opposed to the ergonomics standard. To do

otherwise is to tell America’s workers that they are simply expendable.

COST OF INJURIES

American workers are currently paying the price for these injuries, and the costs

to them, their employers and society are immense. The recent review by the National Academy of Sciences concluded that the total bill to the U.S. economy for

Workers Compensation and other medical/disability costs, and for lost productivity,

amounts to between $45 and $54 billion annually, or about 1 percent of our Gross

Domestic Product. This is an immense sum.

The Liberty Mutual company, the nation’s largest workers compensation insurance carrier, has repeatedly called attention to the high costs of back injuries and

other disabilities related to ergonomic hazards. Their data on disability costs figured

prominently in OSHA’s estimate that each disabling injury prevented by a reasonable ergonomics program would yield injury-related cost savings averaging $22,000.

Who is paying these costs now? Billions of dollars of these costs are now paid by

employers. Many of these employers should know better—and invest in the simple

equipment to prevent injuries. But they unfortunately are not willing to make even

these small investments for worker safety and require an OSHA standard to simply

get their attention.

Other costs—often great than employers pay—are paid by workers and their families. The daily pain and agony of back pain or carpal tunnel syndrome. The inability

to pick up a child or a frying pan. The depression from severe disability and the

fear of family economic survival.

Other costs are paid by the taxpayer, as workers tossed overboard are washed

ashore as recipients of Social Security Disability benefits and Medicaid.

In addition there are substantial benefits to employer from ergonomic investments

that improve productivity. Whether it is a simple shelf or conveyor in a warehouse,

or redesigning an entire assembly line to reduce lifting of parts and tools, the improvements in productivity which OSHA identified during the rulemaking hearing

are common, sensible and often quite impressive.

CONCLUSION

These costs—and benefits—are immense. They are the very reasons that the Congress passed the OSHAct in the first place.

The benefits are achievable, and are exactly what’s needed to preserve real jobs

for working families in a period when so many working families are left behind.

We urge the Congress to immediately restore OSHA’s authority to adopt an

Ergonomics Program Standard, and to compel OSHA to issue such a standard with

all deliberate speed.

UNION OF NEEDLE TRADES INDUSTRIAL AND TEXTILE EMPLOYEES, DISABLING WORKER INJURIES

AND ILLNESSES, 1987–1994, LEAR CORP. (FORMERLY MASLAND INDUSTRIES INC.),

LEWISTOWN, PA

Injuries Repetitive motion cases

Number Lost days Number Lost days

Pre-OSHA inspection:

1987 ...................................................................................... 76 460 37 462

1988 ...................................................................................... 110 955 31 608

1989 ...................................................................................... 49 887 35 527
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UNION OF NEEDLE TRADES INDUSTRIAL AND TEXTILE EMPLOYEES, DISABLING WORKER INJURIES

AND ILLNESSES, 1987–1994, LEAR CORP. (FORMERLY MASLAND INDUSTRIES INC.),

LEWISTOWN, PA—Continued

Injuries Repetitive motion cases

Number Lost days Number Lost days

Post-OSHA:

1990 ...................................................................................... 48 473 17 324

1991 ...................................................................................... 21 33 15 206

1992 ...................................................................................... 20 202 9 1

1993 ...................................................................................... 29 209 9 188

1994 ...................................................................................... 29 64 19 75

Senator SPECTER. Thank you. Mr. Doug Bonacum, director of Patient Safety, Kaiser Permanente.

STATEMENT OF DOUG BONACUM, DIRECTOR, PATIENT SAFETY, KAISER PERMANENTE

Mr. BONACUM. Thank you for the opportunity to testify here

today. I am the director of Patient Safety and Environmental Safety for Kaiser Permanente, the largest private nonprofit provider of

health care services in the United States, with approximately 8.2

million members in 9 States and the District of Columbia.

Our mission is to provide high quality health care services to improve the health status of our members in the communities we

serve. In support of this mission, the organization strives to provide

a safe, healthy and supportive work environment for our employees, our physicians and our members. We believe an important

component of this objective is to identify, evaluate and mitigate

ergonomic risk factors that challenge our work force.

I am here today to discuss strategies for minimizing and preventing work injuries and illnesses related to risks associated with

musculoskeletal disorder and will highlight one particular

ergonomics-based application of this approach at Kaiser

Permanente. Kaiser Permanente’s occupational injure and illness

reduction strategy is based upon a multifaceted approach that begins far upstream of worker injury illness and ends with the safe

and efficient return to work program.

Our focus is on engineering controls, safe work practices and injury response and recovery in that order while our current OSHA

recordable case rate is about average for our industry, we are confident that the program elements we have put in place will measurably improve our safety record.

We are initially focusing our energies in two primary areas,

housekeeping and patient handling. For injuries occurring during

2000 alone this constituted approximately 30 percent of our workers compensation cases and costs. The majority of injuries in both

areas result from overexertion.

As our nursing work force is aging with the demand for new

nurses exceeding the current supply, our inpatient population is becoming sicker and often heavier. As a result, we are particularly

concerned about the back safety of our nursing staff. For this reason we have begun implementing an aggressive back safety program, targeted patient handling, that is now in its second year of

a 2 year project to demonstrate the efficacy of patient handling
183

equipment, training and monitoring in significantly reducing back

injuries to our patient care staff.

There are, of course, numerous reasons for lifting and transferring patients in the course of care. For example, ambulating a patient after surgery may be a significant part of the healing and recovery process or lifting a wheelchair dependent patient to an exam

table provides the caregiver with an appropriate opportunity to facilitate a more through and complete physical examination. Without the right equipment, training and patient—without the right

equipment and training, patient repositioning, lifting and transfer

tasks that seem to go without hitch on TV can result in musculoskeletal strains resulting in painful, life-changing injuries to our

precious work force.

With 27 of our 29 owned and operated hospitals located in the

State of California, we are currently focusing our patient handling

ergonomic interventions there first. At the core of this program is

patient handling equipment.

The patient handling equipment we have selected includes

vertical lifts, pivot transfer aids, special patient chairs and lateral

transfer devices. The selection process was performed with input

and hands on evaluation from employee user groups, expert advice

from consultants and discussions with other health care organizations using similar equipment.

There are three primary methods for utilizing the patient handling equipment with the most preferred option being full time

staff dedicated to the use of the equipment and associated tasks.

The dedicated patient handling lift team is recruited, trained and

assigned accountability for identified high-risk tasks. On average,

there may be two patient lift teams per 250 hospital beds. They

generally conduct lifts in pairs and depending upon the hospital’s

accident experience and resources, may be staffed during one shift

or around the clock.

Prior to joining Kaiser Permanente the individual leading our

program implemented a patient handling lift team in another

health system in California and achieved a reduction of back injuries of over 80 percent during a 3 year period. We are looking to

do the same.

Employee participation has taken place on all back safety interventions and many are sponsored by local management partnership

committees that typically include employee representation. Kaiser

Permanente’s labor management partnership is about engaging our

work force from problem solving through strategic planning in

order to attain our mission of providing high quality care to our

members. In short, worker safety is part and parcel to our partnership.

While the primary focus of our early efforts on back safety have

been on the worker, we recognize there are linkages to and

synergies with other critical performance areas including patient

safety, facilitating adequate path for our members with disabilities

and compliance with state OSHA requirements.

PREPARED STATEMENT

In other words, we feel the appropriate application of ergonomic

interventions at Kaiser Permanente will have far-reaching, positive
184

impact well beyond our primary goal of ensuring worker safety. For

Kaiser Permanente, a healthy work force operating in a safe workplace is part of our commitment to providing high quality affordable care. Thank you.

[The statement follows:]

PREPARED STATEMENT OF DOUG BONACUM

Chairman Specter and Committee Members: Thank you for the opportunity to testify here today on the very important issue of ergonomics. I am Doug Bonacum, the

National Director of Patient Safety and Environmental Health and Safety for Kaiser

Permanente in Oakland, California. I would like to take a few minutes to discuss

some of the efforts Kaiser Permanente is undertaking to improve ergonomics in our

workplaces.

KAISER PERMANENTE

The Kaiser Permanente Medical Care Program is a predominantly prepaid, group

practice health maintenance organization that is committed to providing excellence

in both quality of care and quality of service. In each region in which it operates,

Kaiser Permanente is composed of three closely cooperating organizations: Kaiser

Foundation Health Plan, Inc., a California nonprofit corporation that is a federally

qualified HMO; or one of its regional health plan subsidiaries; Kaiser Foundation

Hospitals, a California public benefit corporation, which provides or arranges for

hospital services to our members; and the Permanente Medical Groups, which are

multi-specialty physician group practices organized as partnerships or professional

corporations and which provide or arrange for all medical services our members require.

Founded in 1945, Kaiser Permanente is the largest private, non-profit provider of

health care services in the United States, with approximately 8.2 million members

in 9 states and the District of Columbia. We operate 29 acute care medical centers

and 423 medical offices in which we employ approximately 90,000 people. More than

11,000 physicians practice within the Permanente Medical Groups.

The mission of Kaiser Permanente is to provide affordable, high quality health

care services to improve the health status of our members and the communities we

serve. In support of this mission, the organization strives to provide a safe, healthy,

and supportive work environment for our employees, physicians, and members. We

believe an important component of this objective is to identify, evaluate, and mitigate ergonomic risk factors that challenge our workforce.

ADDRESSING ERGONOMIC ISSUES IN THE HEALTH CARE WORKPLACE

While significant media attention has more recently been focused on patient safety, the healthcare industry is not without its fair share of worker health and safety

risks as well. These include potential exposures to bloodborne pathogens and infectious diseases, high-level disinfectants, sterilants, anesthetic gases, and laboratory

chemicals, and occupational injury and illness from such activities as patient lifting

and transport. I am here today to discuss strategies for minimizing and preventing

worker injuries and illnesses related to risks associated with musculoskeletal disorders, and will highlight one particular ergonomics-based application of this approach at Kaiser Permanente.

For the purposes of this discussion, ergonomics means the practice of adapting the

physical environment and implementing safe work practices consistent with a

human being’s capabilities and limitations, resulting in optimal individual health

and productivity. While the overall goal of an ergonomics program should be to ultimately eliminate occupational injuries and illnesses caused by ergonomic stressors,

our guiding principles include trying to put the least amount of stress on the body’s

framework, requiring the least amount of physical work by tissues and joints to

maintain safe postures and positions while providing high quality care. We look to

minimize or prevent the cumulative application of biomechanical stress to tissues

and joints by identifying and controlling the following risks: (a) The frequency of

specific physical motion or exertion known or believed to potentially cause harm, (b)

The force or physical exertion /pressure applied to vulnerable parts of the body during specific motions, and (c) The duration or length of period in which an activity

occurs that leads to the risk of an ergonomic injury.

Kaiser Permanente’s occupational injury and illness reduction strategy is based

upon a multi-faceted approach that begins far upstream of worker injury or illness,

and ends, in the event of an injury or illness despite best efforts to avoid it, with
185

a safe and efficient return-to-work program. It is based on a safety hierarchy that

addresses risk in the following fashion: (1) Eliminate, (2) Mitigate, (3) Administrate,

(4) Educate, and when necessary, (5) Remediate. In other words, the focus is on engineering controls, safe work practices, and injury response and recovery, in that

order. While our current OSHA Recordable Case Rate is about average for our industry, we are confident that the program elements we have put in place will measurably improve our safety record. These elements include:

(1) Mandatory design and construction standards for casework, furnishings, and

the work environment, as well as mandatory purchasing requirements for ergonomic

accessories. Multi-functional teams develop these standards with representatives for

our physicians, nursing staff, other caregivers, and administrators. Because Kaiser

Permanente is an Integrated Delivery System, we can ensure that each of our newly

constructed or renovated facilities is designed with adherence to our internal standards, and products and materials are purchased from contracts that include

ergonomically correct equipment.

(2) Training and education efforts that include new employee orientation, an online refresher course addressing basic ergonomic principles and procedures, and task

or job specific training for high risk areas (e.g., patient handling).

(3) The application of on-the-job hazard recognition and control principles principally applied to patient handling and housekeeping operations, as well as repetitive laboratory and back-office procedures.

(4) An active medical management program that has been instrumental in getting

injured employees back to the workforce in a safe and efficient manner.

(5) Performance monitoring and internal reporting systems based upon workers’

compensation case rates, as well as program evaluation to assess and report compliance with internal standards, best management practices, and various State regulations.

We are initially focusing our energies in two primary areas: Housekeeping and

Patient Handling. For injuries occurring during 2000, these two areas alone constituted approximately 30 percent of our workers’ compensation cases and costs. The

majority of injuries in both areas result from overexertion. As our nursing workforce

is aging, with the demand for new nurses exceeding the current supply, our in-patient population is becoming sicker and often heavier. As a result, we are particularly concerned about the back safety of our nursing staff. For this reason, we have

begun implementing an aggressive back safety program targeted at patient handling.

We are currently in the second year of a two-year project to demonstrate the efficacy of patient handling equipment, training, and monitoring in significantly reducing back injuries to our patient care staff. We have benchmarked with other

healthcare organizations and partnered with a recognized industry expert in formulating our approach and expect to achieve significant reductions of back injuries in

targeted areas well in excess of 50 percent.

Anyone who watches one or more of the popular television hospital dramas will

often see a team of people manually, and seemingly, comfortably transferring a patient from gurney to bed or bed to wheelchair, for example. These types of lifts or

transfers occur repeatedly in the course of diagnosis, treatment, and recovery, both

in the hospital environment, and across the continuum of care. Unfortunately, patient handling is seldom comfortable and often done without the aid of a large team

of people. This has resulted in significant back issues for nursing workforces.

There are numerous reasons for lifting and transferring patients in the course of

care. For example, ambulating a patient after surgery may be a significant part of

the healing and recovery process; transferring a patient from gurney to procedure,

exam or radiology table may be required to ensure the patient receives the appropriate examination or follow-up care; and aiding patients in unexpected situations

such as assisting a patient who has fallen to the floor. Lifting a temporarily disabled

or disabled wheelchair-dependent patient from a wheelchair to an exam table provides the caregiver with an opportunity to facilitate a more thorough and complete

physical examination. Without appropriate equipment, training, and feedback, these

patient repositioning, lifting and transfer tasks that go without hitch on TV, can result in musculoskeletal strains, resulting in painful, life changing injuries to the

workforce.

With 27 of our 29 owned and operated hospitals located in the State of California,

we are focusing our patient handling ergonomic interventions here first. We are piloting an approach which provides flexibility in individual hospital implementation,

but, at its core, consists of the following four main elements:

—The identification, selection, and implementation of lift equipment to take

strain off the backs and shoulders of our workforce and place it instead on the

mechanical arms of engineering controls.
186

—Development of expected practices and protocols for utilizing the equipment and

lifting patients.

—Training and education for the affected work force on basic ergonomic principles, the mechanics of safe lifting, utilization of the equipment, and the application of safe work-practices.

—Program monitoring, modification, and back-injury reduction tracking and reporting.

The patient handling equipment we have selected includes vertical lifts, pivot

transfer aids, special patient chairs, and lateral transfer devices. The selection process was performed with input and hands-on evaluation from employee user groups,

expert advice from consultants, and discussions with other healthcare organizations

using similar equipment. The patient care team develops consensus on the application and utilization of the lift equipment including who will use the equipment, how

to use it, and when it will be used.

There are three primary methods for utilizing the patient handling equipment, including: (1) Training current staff how and when to use the equipment, (2) Designating select staff members to use the equipment as patient handling specialists,

or (3) Hiring full time staff dedicated to the use of the patient handling equipment

and associated tasks (preferred strategy). The dedicated staff patient handling ‘‘liftteam’’ is recruited, trained, and assigned accountability for identified high-risk

tasks. On average, there may be 2 patient lift team members per 250 hospital beds

for any eight hours of hospital coverage. They generally conduct lifts in pairs, and,

depending upon the hospital’s accident experience and resources, may be staffed

during one shift or around-the-clock. Prior to joining Kaiser Permanente, the individual leading our program implemented a patient handling lift-team in another

health system in California and achieved a reduction of back injuries of over 80 percent during a 3 year period. We are looking to do the same at Kaiser Permanente.

The initial estimated cost for purchasing the lift equipment averages approximately

$100,000 per center. At an estimated average cost of $20,000 per back injury, even

the strictly financial return on investment from the appropriate selection and implementation of lift equipment can be as short as one year.

To date, we have fully implemented patient handling projects in 9 medical centers, three of which are piloting the lift team intervention, and we are on track to

have full implementation in the remaining medical centers by year-end. We will

monitor the Program’s success through quarterly workers’ compensation case rate

reports, as well as using an internal audit program to ensure compliance with relevant Kaiser Permanente Standards and Federal and State regulatory requirements.

Employee participation has taken place on all back-safety interventions and many

are sponsored by local Labor-Management Partnership committees or Local Safety

Committees that typically include employee representation. Kaiser Permanente’s

Labor Management Partnership is about engaging our workforce, from problem solving through strategic planning, in order to attain our mission of providing high

quality care to our members. The objective of the Partnership is to create a culture

of consultation within the organization, in which labor and management routinely

collaborate to address issues of operations, the quality of patient care, and the quality of work life at Kaiser Permanente. In short, worker safety is part and parcel

to our Partnership.

While the primary focus of our early efforts on back safety have been on the worker, we recognize there are linkages to and synergies with other critical performance

areas including Patient Safety, facilitating adequate care for our members with disabilities, and complying with California OSHA requirements for reducing occupational injuries and illnesses. An example of the Patient Safety connection is recognition that a member who is routinely and safely ambulated after surgery has potentially less chance of falling, acquiring bed sores, contracting a respiratory illness,

or suffering an increased hospital length of stay due to slower than expected recovery. The linkage to providing appropriate care for our disabled community is as simple as ensuring that a wheel chair bound patient can be safely transferred from

their wheel chair to an exam table for a complete and thorough examination. In

other words, we feel the appropriate application of ergonomic interventions at Kaiser Permanente will have far reaching, positive impact well beyond our primary goal

of ensuring worker safety. In short, a healthy workforce, operating in a safe workplace is part of our commitment to provide easier access and delivering high quality,

affordable care.

Thank you for your time. I would be happy to answer any questions you may

have.
187

Senator SPECTER. Thank you, Mr. Bonacum. I had hoped that

Secretary Chao will stay for the entire hearing. She was unable to

do that. I know she has representatives here and I think that there

have been some illustrations here where employers and employees

have come very close and I am impressed with what you said, Mr.

Bonacum, as to what Kaiser Permanente has done. And the testimony of the auto industry is also a model where they are getting

pretty close. And I think what Mr. Sparlin said about the OSHA

bureaucratic response is understandable too. May not be so much

the regulations, but the way OSHA enforces them or interprets

them which really requires a lot more supervision so that you get

to the important spots but you do not create a climate where

there’s so much resistance because of excesses.

So Mr. Fruman’s testimony I think is important in identifying

companies which have gone along a way and I’d be interested to

find out why some of those companies didn’t come in to testify.

I have a lot of questions but it is now past noon and we have

another panel, so I am going to thank you all very much.

Mr. SPARLIN. Mr. Chairman, before we adjourn it is unfortunate

that this forum was used as a means to impugn this particular

company, UPS, but may I be afforded an opportunity to briefly respond.

Senator SPECTER. Sure. I do not know that we’ve impugned

them, but go ahead.

Mr. SPARLIN. Well, there was an accusation about UPS and——

Senator SPECTER. Well, it was said they didn’t come in to testify.

Mr. SPARLIN. Well, it was said that they—I believe it was a little

stronger, but the record will speak for itself.

Senator SPECTER. That is okay, if you want to reply, go ahead.

Mr. SPARLIN. Yes. UPS has never made a secret from anyone

that it is engaged in ergonomic programs and having a great deal

of success. But what Mr. Frumin and many others seem to fail to

appreciate is that any time you use the E word, it doesn’t necessarily mean the same thing.

UPS does not vigorously oppose an ergonomic standard simply

because it likes to pay lawyers to engage in a big battle. It is opposing the ergonomic standard because it does not believe, and I

believe your observations are very much on point, that the direction that OSHA is taking is a proper one and moreover, it is very

concerned that this is not frankly something that can be articulated. I mean, you’ve articulated the goals as to what we might

want to accomplish.

But frankly you have two paradigms. One is the proposed standard where OSHA basically went to employers and said if you find

a problem, go forth and fix it and they didn’t give much guidance.

And so employers didn’t know what to do. So they complained

about that and OSHA gave us a final standard which they didn’t

give us a right to comment on which gave eight specific hazard

identification tools.

Senator SPECTER. They did not give you a right to comment——

Mr. SPARLIN. On the final standard, that is correct. And the

problem there was those particular tools lacked scientific support,

were inconsistent with one another, and frankly did not achieve the

goal of backing away from the excesses that we believe are appar-
188

ent here. So that is the problem we’re faced with and frankly, it

is a very difficult challenge but from the economic perspective what

we need to do is get away from just the notion of coming up with

anecdotes and, you know, anything that we can label ergonomic we

make claims about it and we put a price tag on and even as we

change the standard we do not change the price tag. We have got

to be very specific about what it is we are expecting from employers, what we expect to gain from it, what we expect it to cost, be

honest about doing the calculations and do them very carefully and

with hard data support.

Senator SPECTER. Well, Mr. Sparlin, you made some valid points.

It may be that the input from a lot of companies which have had

success will be very helpful in formulating a standard and then it

may be that the application and supervision of the standard really

ought to have representatives of all sides, business and labor, so

that you do not have just OSHA doing it. Too often, and this is not

a reflection on the Federal work force, the agencies become excessive in their application. Happens all the time. Lots of lawsuits go

up on the administrative process. Maybe we need some umpires

from business, from labor, to take a look at it and try to put some

balance in the implementation of the regulations.

Mr. Frumin, I see you moving forward in your chair. Having had

a reply to you, would you like a surrebuttal?

Mr. FRUMIN. I would appreciate the opportunity, Senator.

Senator SPECTER. Go ahead.

Mr. FRUMIN. Mr. Sparlin’s comments regarding a good faith effort by UPS flies in the face of their lack of participation in any

constructive form in this process. We did not, OSHA did not, receive the benefit of UPS’s detailed cost analysis of their own

ergonomics program during the rulemaking hearing or during the

years and years and years of earlier discussions, debates, stakeholder meetings, committee meetings, et cetera, et cetera.

What are the actual costs of the employers who have implemented ergonomics programs? OSHA begged industry and their

representatives to provide that information repeatedly since 1991

and companies like UPS and others preferred to sit on the sidelines, withhold their real world information and shoot at OSHA for

doing the wrong thing. Other companies which had spent the

money, most of them unfortunately did not provide that information.

Senator SPECTER. Mr. Frumin, the subcommittees will make an

inquiry on the UPS, what you’ve suggested. If you have other companies, let me know.

Mr. FRUMIN. Well, we invite you to come to Lewistown and meet

one.

Senator SPECTER. Okay, I go to Lewistown with some frequency.

I’ll do my best to stop in.

We’re moving now to panel five. It says Mr. Fellner again. It

couldn’t be true that it is Mr. Fellner again, could it?

Mr. Sparlin, we have Ms. Seminario again and Jacquelin Nowell

and Jerry Wood. Ms. Nowell, let’s begin with you, if we may.
189

STATEMENT OF JACQUELINE NOWELL, DIRECTOR, SAFETY AND

HEALTH, UNITED FOOD AND COMMERCIAL WORKERS INTERNATIONAL UNION

Ms. NOWELL. Thank you very much.

Senator SPECTER. Director of Safety and Health, United Food

and Commercial Workers International Union.

Ms. NOWELL. Thank you Mr. Chairman. United Food and Commercial Workers represents 1.4 million workers in the United

States and Canada, primarily in the retail trades and food processing industries.

The UFCW strongly supported the repealed OSHA ergonomic

standard because it contained the basic core elements that we

helped develop with our companies over the last 10 years, 12 years,

the same elements that OSHA saw was working in companies,

those of medical management, job analysis and control, worker involvement, training and surveillance. We had hoped that a standard would get this beyond just our industries and the industries

that other panelists have talked about where this is working so

that all workers would be protected.

We have been involved in this issue for 20 years. We know that

controlling exposure to ergonomic hazards worked. We’ve seen it

happen. Our members were being hurt in record numbers.

Ergonomics really was the answer.

I want to raise a couple of issues, one is the issue of guidelines.

I brought with me a copy of the red meat guidelines that Secretary

Chao has referred to in her submitted testimony.

Contrary to her testimony, these must be taken in context. These

came out in 1990 right in the middle of intense enforcement activity by the agency in this industry. There were record numbers of

injuries in here, rampant medical mismanagement of workers.

There was major enforcement activity, very high fines for lack of

record keeping, for example, for not treating workers medically.

In that context, these guidelines were developed and they were

developed in the context of OSHA moving forward on a standard.

They would not work in a vacuum. They only were successful because they were part of that whole picture, so that needs to be in

this record. We have participated in these types of programs over

the years, including the corporate-wide settlement agreements that

came out of this massive enforcement effort that was done in the

meat packing industry.

Let me get at a few of the statistics which are very real, not only

from the Bureau of Labor Statistics but from the industries themselves. The Bureau of Labor Statistics, if you look at their statistics

from 1991 to 1996 there was a 38 percent reduction in the rate of

MSDs, right at the heart of again, enforcement, the red meat

guidelines and a push for a standard from the agency and the department itself.

The AMI itself testified during the hearings that there was in 10

years since the enforcement and guidelines reduced levels of injuries and illnesses by a third and half of the lost time injuries had

been reduced.

The Food Marketing Institute, one of the trade groups that was

foremost in trying to trash this whole process of a standard states

that there was a 30—there has been a 33 percent reduction in the
190

number of injuries and illnesses caused by ergonomic hazards in

the course of their work trying to reduce them.

One meat packing plant reports a 75 percent reduction in turnover and having recouped all of their investment, economic investment over a 2-year period of first putting in this program. Another

over 10 years reports a 78 percent reduction in MSDs.

PREPARED STATEMENT

I want to speak to the injuries themselves. Senator Harkins

spoke of Gloria Boyd this morning. Not only was she injured on the

job but when she had to move off a job that the company refused

to fix, so that all workers could work it, she lost about $100 a

week. That is not only a physical injury but a financial injury to

these workers. Workers need protection programs that—programs

work but only in the context of enforcement. We must have a

standard for all workers. Thank you.

[The statement follows:]

PREPARED STATEMENT OF JACQUELINE NOWELL

Good morning, my name is Jacqueline Nowell and I’m the Director of the Occupational Safety and Health Office, the United Food and Commercial Workers International Union, UFCW.

The UFCW is the largest private sector union in North America, representing 1.4

million workers in the retail food, warehousing, healthcare, garment and textile,

footwear and chemical industries. We are the largest organization of food processing

workers in the United States. We put breakfast, lunch and dinner on the table for

America’s families. To feed America’s families, thousands of food processing workers

are needlessly crippled and maimed each year. Meatpacking and poultry processing

have some of the highest incidences of repetitive motion injuries in the country.

The UFCW strongly supported OSHA’s ergonomics program standard. We have

been actively involved in this issue for nearly 20 years, since the early 1980s. Our

members were being hurt in record numbers. We began by educating them about

the problems of musculoskeletal disorders, MSDs, and the lack of programs and

fixes for them in our industries. We filed OSHA complaints in the meatpacking,

poultry and cat fish industries. We pressed Labor Secretary Elizabeth Dole for a

standard to address the workplace hazards causing MSDs. We worked closely with

the Department of Labor and Secretary Dole in developing the Red Meat Guidelines,

issued in 1990. In 1991, the UFCW, AFL–CIO and 29 other unions petitioned OSHA

for an Emergency Temporary Standard. In 1992, under Secretary Lynn Martin, the

Department of Labor agreed with the unions that available information supported

initiation of Section 6(b)(5) rulemaking under the OSH Act to address ergonomic

hazards. The OSHA ergonomics standard was 10 years in the making, begun by a

Republican administration, and long overdue. This standard that was designed to

prevent crippling MSDs, the nation’s number one job safety problem, was debated

in the Senate for 10 hours, while the House gave the issue one hour of consideration. It was finally killed when the President signed the repeal on March 20, 2001,

two months after it had gone into effect.

My testimony today will focus on why a standard is needed, through worker stories and successful ergonomics programs in our industries. I would be remiss, however, if I did not take this opportunity to let you know how disappointed our members were with the elimination of the ergonomic standard. By using the Congressional Review Act, a previously unused and untested legislative tool, the ergonomic

standard was obliterated. Workers now feel, with some justification, that the Federal government has turned it’s back on their ergonomic injuries. I would like to

submit for the record a copy of a letter that was sent by our International President,

Doug Dority, to Members who killed the worker safety standard. At the same time,

we feel nothing but gratitude to those who stood up when workers needed it most.

MSDs are real injuries—they often lead to disability and can have a lifetime affect

on workers lives. Caroline Shebora is a cashier in a grocery store in Alexandria, Virginia. She’s had bilateral carpal tunnel surgeries and is fearful that it’s coming

back. Her company fought her worker’s compensation claim for over 11⁄2 years, and

she feels devastated by that after working for this one company for 27 years. Jan
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Garrett works in a poultry plant in Kentucky, where she worked salvage, until she

started having problems with her hands. She’s also had bilateral carpal tunnel surgeries. Her job, at a line speed of 140 birds per minute, was to cut off broken wings,

broken legs, cut skin off that had gall stains, cut tail gland if the machine missed

it, anything USDA sent down because they knew Jan would wash, cut, trim and

vacuum trying to salvage any of the bird at all. Her life has been completely

changed, both at work and home. She can’t hang out her laundry, can’t clean her

house, especially using cleaners that come in spray bottles. Her family bought their

first home last summer and her husband and sister had to clean it. To this day,

she still hasn’t been able to wash the windows. She is afraid, now that she’s back

on a knife job at the plant, that she won’t be able to keep up, and the plant will

tell her they have no work for her. Gloria Boyd has worked at the IBP pork processing plant in Waterloo, Iowa for nine years. She was diagnosed with carpal tunnel

syndrome as a result of the job she did, cutting bone from picnic hams. She couldn’t

do anything, couldn’t especially grip a knife. She was off the job, on light duty for

six months. Getting injured was a real financial as well as physical hardship. She

lost her incentive, her pay was reduced $100 a week. She was never able to go back

to the higher paying knife job, because every time she tried, the CTS would come

back.

The UFCW has many ergonomics programs with full union participation in our

represented industries that are working to reduce MSDs. Many industries we represent have recognized the problem for more than 15 years, and have developed

ergonomics programs. These include meat, cat fish, retail and boot and shoe. One

meatpacking company reduced its worker’s compensation costs by nearly 60 percent,

reduced turnover by 75 percent and recouped all of their investment in the first two

years of the program. In the first two years of the program, the number of diagnosed cases of MSDs was halved and the number of surgeries in the plant fell by

40 percent. Another collectively-bargained ergonomics program in meatpacking has

a worker doing most of the ergonomic changes in the plant. That plant has reduced

the number of MSD cases in the 10 years of the program by over 78 percent! In

a boot and shoe plant, MSD cases were reduced by 70 percent in two high-hazard

departments after the company began an ergonomics program. The standard was

programmatic rather than specification-based, meaning it was a flexible set of requirements that business would have been able to adapt to its establishments. And

it was based on the experience of companies like our, ones that have developed and

implemented successful ergonomic programs.

The retail industries have recognized the problem of poor ergonomic design for

years. One chain, Stop and Shop Supermarket Company, has a joint program with

the UFCW that addresses the high hazard areas of the stores and provides training

for the Safety and Ergonomics Committees in each store. The Food Marketing Institute, a trade group for the industry, has educated themselves and their members

about the issue of MSDs and back injuries related to job design as well as commissioned and gathered scientific data on the issue. As well, they claim that the injury

rate has declined 33 percent in 10 years of voluntary grocery industry efforts to reduce worker injuries. Unfortunately, this same trade group made exaggerated

claims about the ergonomics standard, telling its members that they would suffer

greatly from a mandatory standard, including that they would have to hire baggers,

that customers would have to bag their own groceries and that the price of groceries

would increase as a result of the standard. They also claimed that baggers, according to the standard, would be prevented from lifting more than 15 pounds. These

scare tactics we believe aimed at generating opposition to the standard rather than

concrete criticism of the standard itself, which would have been far more useful for

all parties.

Workers are being hurt—Jan, Gloria and Caroline are but examples of the hundreds of thousands of workers—you can see these workers when you go into your

own neighborhood grocery store—in the United States who are developing MSDs.

They come from small plants and large ones; union ones and non-union ones. The

point is it doesn’t matter where they work, they need protection. We’ve been working to get those protections for them. We think an ergonomic standard is the answer.

Thank you for the opportunity to speak to you about this important issue for

workers.

Attachment:
192

UNITED FOOD & COMMERICAL WORKERS

INTERNATIONAL UNION, AFL–CIO & CLC,

Washington, DC, April 12, 2001.

Hon. ,

U.S. Senate, Senate Office Building, Washington DC.

DEAR SENATOR : The more than 600,000 workers who are injured and crippled

each year from ergonomic hazards in the workplace feel betrayed by the congressional vote on the ergonomics standard. Hundreds of thousands more workers will

now suffer preventable pain and injury as well as needless job and income loss. In

addition, thousands of employers will face additional costs in health care, workers’

compensation, and reduced productivity.

The campaign waged against the ergonomics standard was marked by

misstatements, distortions, and lies. There were no congressional hearings, no public forums, and no opportunities for workers to share their real-life experiences either as casualties of ergonomic hazards or as participants in programs that have

successfully eliminated such hazards. We believe that many votes against the standard were the direct result of the misinformation campaign.

On behalf of the 1.4 million members of the United Food and Commercial Workers International Union (UFCW), I extend to you an invitation to meet with workers, and to visit workplaces that will give you a broader understanding, and allow

you to make a more informed judgement of both the problems and solutions regarding ergonomic hazards. UFCW has nationally recognized model programs that have

both significantly reduced injuries and decreased costs for employers.

UFCW is happy to arrange the meetings with workers and the workplace visits

to meet your schedule.

Secretary of Labor Elaine Chao took the opportunity to meet with workers on

March 14, 2001, at UFCW headquarters. We believe that her willingness to hear

from workers can be an important step in building a consensus on a solution to

ergonomic hazards. As Secretary Chao noted, Congress must be part of the consensus-building process.

We hope you wilt take this opportunity to gain a firsthand understanding of this

issue, and to see the devastation of workers’ lives that comes with ergonomic hazards. Please contact the UFCW Legislative and Political Affairs Department at your

earliest possible convenience to discuss a workplace visit.

America’s workers are counting on you to hear their concerns and act on their

needs for safe workplaces. We hope to hear from you soon.

Sincerely,

DOUGLAS H. DORITY,

International President.

Senator SPECTER. Thank you Ms. Nowell. We now turn to Jerry

Wood, legislative chairman, Local 7800, Communication Workers of

America.

STATEMENT OF JERRI WOOD, LEGISLATIVE CHAIRMAN, LOCAL 7800,

COMMUNICATION WORKERS OF AMERICA

Ms. WOOD. Good afternoon, Senator Specter, Mr. Chair. I am

Jerry Wood, the legislative chair for the Communication Workers

of America Local 7800 in Seattle and I am also a customer communications technician with over 28 years of service for Qwest Communications, formerly US West and Pacific Northwest Bell.

I really appreciate the opportunity to testify before you and your

committee today. I would like to address two important issues regarding workplace ergonomics, the first involves achieving economic—excuse me, ergonomic changes in the workplace. I will illustrate this concern by presenting a success story between my union,

the Communication Workers of America and our employer of record

at that time, US West which is now known as Qwest. The second

deals with what still needs to be accomplished regarding workplace

ergonomics.

Mr. Chairman, in 1990 when our company was US West, we had

a work group known as the centralized mail remittance center that
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processed all incoming payments for our—from our company’s customers. The job entailed the following procedures: workers loading

mail into a machine that sliced the envelopes open, removing the

mail like the bills, checks, cash from the envelopes, keying in the

payment information and processing the received checks and cash

and then finally collecting and bundling the paper documents.

The performance of this work involved extensive repetitive motions performed in very hot and extremely dusty and dirty working

conditions. In turn, these conditions laid to the occurrence of a high

rate of employee repetitive motion illnesses, cases of skin rash and

resultant Workers Compensation claims and awards. In addition,

worker morale and productivity were extremely low. It was not a

very pretty picture.

Initially my union attempted to resolve these issues with US

West through our collective bargaining process. For an extended

period of time, affected employees complained to the management

and to the local union stewards of the inadequate ergonomic working conditions and the related health problems.

In turn without success, the union utilized the contract’s grievance process. However, lacking—excuse me—lacking agreement

from the employer to provide safe and healthful working conditions

necessary to minimize or eliminate the identified repetitive motion

problems, CWA filed a complaint with WISHA, which is our Washington State Industrial Safety and Health Administration for relief.

In 1992 after citing the company under the general duty clause

of the Occupational Safety and Healthy Act for violations regarding

inadequate ergonomic working conditions, WISHA and the employer negotiated a settlement agreement intended to resolve the

identified areas of concern.

Mr. Chairman, the settlement agreement resulted in US West

providing ergonomic and safe and helpful working conditions for all

affected employees in that workroom. Components of the settlement agreement included the establishment an ergonomic task

force, the development of a workplace ergonomics training program—excuse me—program. Subsequently initial and refresher

training was provided to all current and new employees. Training

topics included the principles of ergonomics, appropriate body postures, the proper positioning of your hands, your wrists, your legs,

illumination and glare, and the use of physical exercises and

stretch breaks and the reporting of occupational injuries and illness.

The creation of an ergonomics program. This program included

the conducting of periodic work site inspections. In turn, short and

long-term recommendations for improvements in working conditions remains. The implementation of lighting fixtures and the provision of appropriate workplace illumination. The provision of appropriate physical workplace accommodation such as foot rests,

wrist rests and back supports and I’ll hurry up as I see the yellow

light is lit.

All of these topics are important components of a comprehensive

ergonomics program and standard and since the negotiation and

implementation of this settlement agreement, our members have

not experienced any complaints of pain, discomfort or illness associated with repetitive motion or cumulative trauma and that is been
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for almost 8, 9 years now. No one has had a problem in this work

group.

Mr. Chairman, when this problem was identified nearly everyone

in this work group had suffered some form of musculoskeletal or

cumulative stress disorder. And what does that mean? For business

it means money. The return on investment is great. With fewer illnesses and injuries the productivity is up. Less money is spent on

medical management and Workmans Compensation. For the employees, they can come to work and not worry about being injured.

There is no loss of earnings and they are able to have a pain free

life both on and off the job.

It is a dollars and cents issue. Unfortunately this is not the——

Senator SPECTER. The time is up. If you could summarize, please.

PREPARED STATEMENT

Ms. WOOD. What I would like to say is that we need a Federal

standard. In our State, in Washington State where I live and work,

we have a proactive ergonomics work rule that was adopted in May

of 2000 and we’re in the process of that now. But US West, Qwest

as we’re now known, we do not have an ergonomic standard that

is a 14 state wide standard. We have individual work groups that

negotiate agreements with managers based on personal relationships or, you know, how the business is in that area.

Senator SPECTER. I think we have your point.

Ms. WOOD. The point is we really do need this standard. Once

the pain starts, it doesn’t stop.

[The statement follows:]

PREPARED STATEMENT OF JERRI WOOD

Good Morning Mister Chairman. I am Jerri Wood, the legislative chair for the

Communications Workers of America, Local 7800 in Seattle, Washington and a customer communications technician with over 28 years of service for Qwest Communications, formerly US WEST and Pacific Northwest Bell Telephone.

I appreciate the opportunity to present testimony before the Subcommittee on

Labor, Health and Human Services, Education of the Senate Appropriations Committee. I would like to address two important issues regarding workplace

ergonomics. The first involves achieving ergonomic changes in the workplace. I will

illustrate this concern by presenting a success story between my union, the Communications Workers of America, and Qwest. The second deals with what still needs

to be accomplished regarding workplace ergonomics.

Mr. Chairman, in 1990, when our company was US West, we had a work group,

known as the Centralized Mail Remittance Center, that processed all incoming payments from the company’s customers. The job entailed the following procedures:

—workers loading mail into a machine that sliced the envelopes open,

—removing the mail, i.e., bills, checks, and/or cash, from the envelopes,

—keying in the payment information,

—processing received checks and cash, and, finally,

—collecting and bundling the paper documents.

The performance of this work involved extensive repetitive motions performed in

very hot and extremely dusty and dirty working conditions. In turn, these working

conditions led to the occurrence of a high rate of employee repetitive motion illnesses, cases of skin rash, and resultant workers’ compensation claims and awards.

In addition worker morale and productivity were extremely low. It was not a pretty

picture. Initially my Union attempted to resolve these issues with US West through

the collective bargaining process. For an extended period of time, affected employees

complained to management and Local union stewards of inadequate ergonomic

working conditions and related health problems. In turn, without success, the Union

utilized the contract’s grievance process. However, lacking agreement from the employer to provide safe and healthful working conditions necessary to minimize or

eliminate the identified repetitive motion health problems, CWA Local 7800 filed a
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complaint with WISHA (i.e., the Washington State Industrial Safety and Health Administration) for relief. In 1992, after citing the company under the General Duty

Clause of the Occupational Safety and Health Act for violations regarding inadequate ergonomic working conditions, WISHA and the employer negotiated a settlement agreement intended to resolve the identified areas of concern.

Mr. Chairman, the settlement agreement resulted in US West providing ergonomic and safe and healthful working conditions for all affected employees. Components of the settlement agreement included:

—The establishment of an ergonomics task force;

—The development of a workplace ergonomics training program. Subsequently,

initial and refresher training was provided to all current and new employees.

Training topics included the principles of ergonomics; appropriate body postures; the proper positioning of hands, wrists, arms, and legs; illumination (and

glare); the use of physical exercises and stretch breaks; and the reporting of occupational injuries and illnesses;

—The creation of an ergonomics program. This program included the conducting

of periodic worksite inspections. In turn, short and long-term recommendations

for improvements in working conditions were made;

—The implementation of appropriate lighting fixtures and the provision of appropriate workplace illumination levels;

—The provision of appropriate physical workplace accommodations such as foot

rests, wrist rests, and back supports. (US West made sure to have an ample

supply of these items so as to eliminate delays in providing them to affected

employees);

—The development of procedures that called for the rotation of job functions within affected work groups;

—The establishment of a medical management program. In part, this involved the

medical surveillance of workers and a review of ongoing employee cumulative

trauma disorders. In addition, affected occupational and management employees were provided education materials regarding the causes and early symptoms of repetitive motion illnesses; and

—The introduction of equipment that would eliminate or significantly minimize

the amount of paper dust within the workplace.

All of these topics are important components of a comprehensive ergonomics program and standard.

Since the negotiation and implementation of the settlement agreement, our members have not experienced any complaints of pain, discomfort, or illness associated

with repetitive motion or cumulative trauma. In addition, exposure to paper dust

has been greatly minimized.

Mr. Chairman, when this problem was identified, nearly every employee in the

centralized mail remittance center work group suffered from some form of musculoskeletal or cumulative trauma disorder. Today, there are no reported cases of repetitive motion illness. What does that mean?

For the business it means money. The return on investment is great. With fewer

illnesses and injuries, productivity is up. Less money is spent on medical management and workers’ compensation. For the employees, they can come to work and not

worry about being injured. There is no loss of earnings. They are able to have a

pain free life both on and off the job. They can participate fully in their family life,

without limitations. These things cannot be measured in dollars and cents. This is

a success story that CWA and US WEST learned a lot from.

Unfortunately, this is not the case in all corporations, and even at Qwest, some

lessons need to be revisited. We still have work groups where ergonomics and work

place safety are unheard of. As we sit here today, many of our members will be hurt

and continue hurting after their workday is finished because the emphasis is on the

bottom line, the all-mighty dollar. For some reason, we as a nation are willing to

play the game of chicken, pitting the financial health of our businesses and the

physical, emotional and financial well being of their employees against this mighty

bottom line.

If you can prevent an injury from happening, you save money in lost time wages,

doctors and therapy visits, prescriptions, hospitalization and so on. Dollars spent in

this manner produce no positive return on the employer’s investment. In fact, they

actually take money away from the bottom line. If employers spend money, as US

WEST did in 1992, creating a safer work place, educating their employees to work

safer and smarter, and providing the necessary accommodations to lessen the impacts of repetitive motion, the employer will experience an increase in productivity,

morale, and employee and customer retention. These are items necessary for successful employers and a healthy, thriving, and growing economy.
196

Mr. Chairman, why do we need a Federal OSHA ergonomics standard? This question is particularly important for employers with multi-state operations, such as

Qwest. A Federal standard would provide for consistent policies and procedures

within all states. On the other hand, the establishment of different standards

among different states such as Washington, California, and others would present

employers with burdensome policy and economic scenarios. In addition, with the establishment of consistent workplace ergonomics policies and procedures, workers

would prefer a Federal standard knowing that they have a greater opportunity to

be provided ergonomic and safe and healthful working conditions.

As stated in the success story that I described, US WEST was not fully motivated

by a collective bargaining agreement or by some sense of doing the right thing in

correcting their problems. An outside governmental agency, i.e., the Washington Industrial Safety and Health Administration, with the authority to inspect, issue citations, and levy disciplinary action was needed to convince the company to take the

necessary protective action. However, WISHA was limited insofar as they could only

use the OSHA General Duty Clause to investigate, issue citations, and take the necessary corrective action. The establishment of a Federal OSHA ergonomics standard

would allow state OSHA plans that do not have an ergonomics standard to more

efficiently and effectively respond to complaints and resolve inadequate workplace

ergonomics.

Mr. Chairman, I have first hand knowledge of the ergonomics and repetitive motion illness problem. I suffer from carpal tunnel and tendonitis in both of my arms

due to my job function at Qwest. I know that if my manager had accommodated

my need for an ergonomic keyboard, I would not be suffering to the extent that I

am today. For the lack of this $25 keyboard, my employer spent over $45,000 in

lost time wages, orthopedic and therapy appointments, prescriptions and braces and

independent medical examinations, not to mention significant administrative costs.

My family lost my ability to help them at some crucial times in their development.

My customers lost my service to them. I am a great technician. However, due to

my repetitive motion illnesses, my co-workers had to work harder; some working

overtime to cover for my absence. My company lost money, because I wasn’t there

to help them make money.

Unfortunately, once the pain and suffering associated with inadequate workplace

ergonomics and the occurrence of repetitive motion illness starts, it never stops.

Mr. Chairman, I urge you to help ease the pain and suffering of millions of American workers who, as a result of inadequate workplace ergonomics, have developed

repetitive motion illnesses by working to have a comprehensive Federal OSHA Ergonomic Standard established.

Thank you for your consideration of this matter.

Senator SPECTER. Thank you. Thank you very much. Going now

to panel number five, Mr. Fellner, Mr. Sparlin, Ms. Seminario.

When you have 26 witnesses, you get sort of repetitive.

Mr. Fellner, it is your turn. I see you are marked down here for

3 minutes, I do not suppose you will need that long, will you?

STATEMENT OF BARUCH A. FELLNER

Mr. FELLNER. Well, as a matter of fact, I may surprise you, Senator Specter, and during the course of my——

Senator SPECTER. I am just kidding, Mr. Fellner, take all 3 minutes.

Mr. FELLNER. I appreciate that, but during the course of—the

reason that I may surprise you is because I think that the search

for the Holy Grail of consensus this morning may breed more success than you had initially predicted or thought. But before I indicate to you where that consensus might be I’d like to correct the

record.

In response to the distinguished chairman’s question directed to

Dr. Barondess as to whether interventions are effective in addressing MSDs and to the NAS’s conclusion with regard to that, he said

yes. Dr. Barondess misrepresented his report. In Appendix C,

which is the panel response to the single descent, the NAS reports
197

states, and I quote in its entirety, this is at page 458, the report

states that interventions influenced pain reports and not the occurrence of specifically defined disorders of the upper extremities. The

studies are summarized in table 8.3. The report does not state that

interventions prevent carpal tunnel syndrome or indeed any other

upper extremity disorder. The emphasis rather is on the amelioration of symptoms which is the end point in the relevant literature.

Furthermore, the comments on upper extremity interventions

carefully state that interventions influence symptoms, not the incidence of specific disorders. With that proposition we agree, and

that means if we return, Senator Specter to where I began, the

NAS defines disorders as an interruption in a human being’s sense

of wellness. If that is what this morning’s hearing is about, Senator

Specter, we can all agree that the workplace does have some influence on individual sense of wellness. Come Monday morning I suspect even you, Senator Specter, are reluctant to come to the Senate. I know I am today.

If that is what ergonomics regulation is about, if OSHA has the

authority, if we are entering 1984 Orwellian period where a Federal agency has the authority to regulate an individual’s sense of

wellness, then we have come very far. Before we do so, Senator, I

think that the Department of Labor must take a good, long look at

the process and at the science and I appreciate it.

Senator SPECTER. We’ll take a close look at the voluminous report and contrast Dr. Barondess statement with your challenge and

see if your challenge is well-founded.

Ms. Seminario, I have you down for 3 more minutes.

STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF OCCUPATIONAL SAFETY AND HEALTH, AFL–CIO

Ms. SEMINARIO. Just to make a couple of points, Mr. Chairman,

as I’ve said earlier we’ve long advocated an OSHA standard. We

have recommended that such a standard be based on the good employer practices that have worked. Those practices are the ones

that are incorporated into the red meat guidelines. They are the

practices that are in place in the UAW program, they are the practices that were in the settlement agreement at Qwest. They are the

practices that are in the settlement agreements in meat packing.

If you line up all of these documents and all of these programs,

they have very common elements. Most of them take a programmatic approach that include employer commitment, employee

involvement, identification of problem jobs, development of controls, training and education, and appropriate medical management, and that is the practice. And the risk factors that are addressed, the exposures that are addressed again are the similar

common exposures that workers have with respect to the development of MSDs.

They are exposure to excessive reputation, force, awkward postures, vibration, jobs involving a lot of manual handling as Dr.

Barondess indicated. So there is commonality when you look at the

practice in the workplace and our advice to the Department of

Labor in developing their rule is to look at that practice and to codify that into a regulation.
198

Does that mean that every employer do exactly what the UAW

does or what’s done at Qwest or, you know, in the meat packing

industry? No, there are, you know, obviously real differences in

risk. There are real differences in operations, but the programmatic

approach, the basic elements are the same and then within that,

the control measures are obviously ones that are tailored to a particular workplace.

But at the heart of all this has got to be the reduction in exposure. If you just have a program on paper, if you have a program

and a process that is not resulting in reductions and exposure, you

are still going to have injury.

Now, much has been said about the fact that there are not only

physical factors but psychosocial and organizational factors and we

agree with that. But when you look at OSHA’s authority to regulate, the physical factors resulting from the jobs are the ones that

they are best able to deal with. If OSHA got into trying to deal

with management structures in the workplace, they got into dealing with management relationships that have—that are at the

heart of the psychosocial work organizational factors in the workplace, you would hear much greater screams from the employers

than you have already heard. And when we asked them about this

at the hearing, should OSHA then address the work organization

and psychosocial factors, they said no.

So OSHA tried to deal with what was in its purview and what

really was the focus of its effort. Was dealing with all risk factors?

No. It was attempting through the standard to deal with those risk

factors that they felt could be regulated related to the workplace

and related to hazards.

So that is our recommendation is to look at these practices and

then to codify them into a regulatory approach to reduce injuries.

Senator SPECTER. Thank you very much, Ms. Seminario and

thank you all. In my experience having been here for some time,

this has been a very unusual hearing and the subcommittee has

gone into a lot more detail to try to understand this problem because of our determination to see something done.

We labored long hours on conferences on this issue, year after

year after year after year and the process that has brought us to

where we are today with the regulation having been rescinded and

we have a statement by the new Secretary of Labor that, quote, I

intend to pursue a comprehensive approach to ergonomics which

may include a new rulemaking that addresses the concern levied

against the current standard. The word may leaves latitude for not.

We intend to press on the time frame. What I hear today is not

likely to lead to consensus but is very adversarial and I am not unused to the adversarial process and I can see the adversarial process at work to try to influence the decision maker. That is not unusual either.

You take an extreme position, you may end up closer to where

you want to be than if you take a conciliatory position. That is sort

of par for the course in adversarial litigation which I think we have

here. But through all of it there’s been a lot of progress through

ergonomics with the companies and we’ve heard employers who

have come to terms.
199

And a big part of the problem is the administration by OSHA of

which we hear complaints everywhere and this subcommittee has

defended OSHA’s budget trying to look more for reconciliation and

prevention than for adjudication and punishment and what is going

to have to happen really in the long run is that the OSHA administration is going to have to be populated by people who understand

the concerns on both sides.

Business is going to have to put one of your high, your really

well qualified people into a key OSHA position to see to it that

OSHA doesn’t overstep the bounds.

The employees at OSHA do not earn what some of the witnesses

do have testified here today and there has to be a safety check

from labor having someone there who will see to it that they do not

go too far in either direction. But the governmental administration

is a monumental task. But this is a really very—I do not have to

say this, it is been said by everybody, an extraordinarily important

program this and this subcommittee intends to pursue it and it is

my hope that we can find some information from some of these

companies which haven’t come forward and try to find some standard to address the concerns on all sides because I think at bottom

there is a good faith effort to try to deal with workers problems,

biggest impacts on corporate profits, we know that. We all have to

live together on the planet earth.

It is exactly 12:30. That is the longest hearing this subcommittee

has had. It is over.

SUBCOMMITTEE RECESS

Thank you all very much for being here. The subcommittee will

stand in recess until 9:30 a.m., on Wednesday, May 2, when we

will meet in room SH–216 to hear from Department of Labor Secretary Elaine L. Chao.

[Whereupon, at 12:30 p.m., Thursday, April 26, the hearing was

concluded and the subcommittee was recessed, to reconvene at 9:30

a.m., Wednesday, May 2.]

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DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

WEDNESDAY, MAY 2, 2001

U.S. SENATE,

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS,

Washington, DC.

The subcommittee met at 9:33 a.m., in room SH–216, Hart Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Harkin, and Murray.

DEPARTMENT OF LABOR

OFFICE OF THE SECRETARY

STATEMENT OF ELAINE L. CHAO, SECRETARY OF LABOR

ACCOMPANIED BY JAMES McMULLEN, DEPUTY ASSISTANT SECRETARY, BUDGET

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. The Subcommittee, of the Appropriations Committee on Labor, Health and Human Services, and Education will

now proceed.

We welcome Secretary of Labor, Elaine Chao, to this first hearing on her Department’s budget.

I note at the outset that the administration’s discretionary budget request for fiscal year 2002 for the Department of Labor is

$11.338 billion, which is a decrease of some $562 million below the

current budget, noting that the total funding for the Department

including mandatory programs is $44.4 billion.

There are some increases including funding for the disability em- ployment policy, somewhat in excess of $20 million; for the consumer price index improvements, a little over $8 million; and for

the unemployment insurance work load program, an increase of

$65 million.

But there are some major decreases in the area of youth activities, dislocated workers, training programs for incumbent workers,

the safe schools healthy students program, youth offenders, and

international labor affairs.

In preliminary staff inquiries, we have been advised that some

of these cuts, may be accommodated by the fact that States have

spending levels at a lower rate than expected.
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But there is a real concern here. Earlier this week, I visited a

Healthy Start Center in Harrisburg, which is devoted to trying to

deal with youngsters who are at risk and may be predisposed to

criminal activity.

I was really startled to hear that the time for dealing with atrisk children is when they are 16 months old. It seemed fanciful

to me until I heard their approach.

They say that at 16 months, children start to learn which space

is theirs, not to be aggressive and pushing other children, learn

scheduling so they have some structure in their life. And that conduct begins at that age.

And they were very much concerned about the programs in

Healthy Start, which has had enormous improvement. Although it

is not funded by this Department, but funded by the subcommittee,

the Healthy Start staff were concerned as to what is going to happen in the summer programs. That is a question which the Congress has faced repeatedly and this subcommittee has taken a very

strong position trying to provide for summer jobs for young people.

And the issue was raised as to daycare. What is going to happen

to daycare in the summer. So when I look at these cuts, I am really

concerned.

I talk about 16-month-olds, because I think that is a bit of information which is sufficiently startling to take just a few minutes

this morning to tell you what the avant garde thinking is on this

subject.

Well, Madam Secretary, we do not have 25 witnesses behind you

today, which will give us a little more of a chance to discuss matters. And we look forward to—I was about to say we look forward

to your statement, but timing is everything.

And, Senator Harkin, among his many, many talents, has a way

of arriving at precisely the right moment.

My distinguished partner, Senator Harkin.

Senator HARKIN. Thank you very much, Mr. Chairman. And I

will just ask my statement be made a part of the record. You are

so gracious. I will just put it in the record and let us move ahead.

Senator SPECTER. Oh, I see that statement. It is too long. We

cannot afford all of that on the record. We are going to have—you

will have to summarize that for——

Senator HARKIN. We will have to get a new appropriation just to

print all this stuff, right?

Senator SPECTER. By the time we finish talking, I think we will

need several new appropriations.

[The statement follows:]

PREPARED STATEMENT OF SENATOR TOM HARKIN

Thank you, Mr. Chairman. And thank you Secretary Chao for coming here today.

It’s nice to see you again so soon. Now you know that when this Committee says

that we want to work closely with you, we’re not kidding!

Budgets are about priorities. In America, where we spend our money reveals a

great deal about what we value. The discretionary funding in this year’s Department of Labor budget is down $600 million. In a year of unprecedented surplus, it

is shocking that we are sitting here discussing deep cuts to an agency whose mission is to protect our Nation’s workers—the very people who worked so hard to

produce a surplus.

Before I get into the concerns I have, I do want to note a positive step made in

this budget. I am pleased to see that the Department has requested a doubling in
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the funding for the Office of Disability Employment Policy, which we created last

year. This office will focus on integrating individuals with disabilities into worker

training programs, improving access to one-stop centers and coordinating with other

agencies to ensure that people with disabilities have transportation and communitybased attendant services. In many cases, a small amount of assistance is all that

is required to give these individuals the independence that a job affords.

Aside from that shining star, I believe this budget is simply short-sighted. First

and foremost, I am confounded by the logic of making large cuts in worker training

programs just as the country experiences rising unemployment rates. Week after

week, we see news reports about lay-offs at major companies, yet your budget calls

for a $200 million cut from training programs for dislocated workers.

If we are to encourage innovation in the marketplace, industry NEEDS highly

skilled workers and it is in our best interests to provide those workers here in

America. I am disappointed to see that, out of the $600 million cut in overall Department of Labor funding, $473.9 million of that comes from Employment and

Training Programs. That is 79 percent of the total decrease in the Department!

Another example of the short-sightedness of this budget is this Administration’s

proposal to cut the Bureau of International Labor Affairs by 65–75 percent. In this

era of globalization, American workers are now pitted against workers throughout

the global economy in tough, hard-nosed competition as never before. Their jobs and

living standards are at unprecedented risk.

Now I am not worried about the productivity of American workers to compete and

win on a level playing field. But the sad truth is there are many trading countries

that deliberately refuse to enforce their own national laws to respect basic worker

rights and labor standards, let alone meet their international legal obligations.

I am deeply concerned that this administration is proposing such drastic cuts in

the part of the Federal Government which has the greatest expertise in labor standards and international worker rights issues, such as abusive child labor. These cuts

could not come at a worse time: U.S. policy-makers need ILAB help more than ever

including President Bush, who says there are legitimate trade-related worker rights

issues that must be addressed in the impending fast-track debate.

Finally, I am disturbed by the reductions in worker safety and health standards.

In the last year, workforce data has illustrated that Americans are working more

hours than ever before. There is a $1.2 million reduction in safety and health standards, a $3 million cut in training grants, cuts in state programs, technical support

and a reduction of 94 full-time staff!

Cutting support for worker training, global workforce and basic safety and health

standards for our workers—these actions are classic examples of cutting off your

nose to spite your face. The surplus was built on the backs of America’s workers

and if we as a Nation want to prosper in the 21st century, we will need a workforce

that is well-trained, highly-skilled, and does not have to fear being injured due to

hazardous working conditions. To do any less is to put America’s prosperity in danger.

SUMMARY STATEMENT OF HON. ELAINE L. CHAO

Senator SPECTER. Well, in a very unusual move, Secretary Chao,

Senator Harkin has deferred to you. I do not think he would have

done it to anybody else.

Senator HARKIN. You are in rare form this morning.

Senator SPECTER. The floor is yours.

Secretary CHAO. Thank you very much. And, of course, to the

ranking member, I appreciate that courtesy.

Mr. Chairman, now that I know what the lights are for, I have

made my statements very short to fit into the time frame. And I

do have a written record—statement that I would like to be submitted for the record.

Senator SPECTER. The full statement will be made a part of the

record. Madam Secretary, with only one witness, we do not use the

lights.

Secretary CHAO. Oh, okay. Thank you.

I do want to address your issues because they are important as

well. I do have a little summary.
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As you mentioned, the Department’s overall fiscal year 2002 budget request is $44.4 billion. It is up from $39.2 billion from the

previous year. It is about a 13.27 percent increase. The FTE’s is approximately 17,483. The discretionary request is $11.3 billion.

I think it is important to point out here that the Department of

Labor’s budget is part of the entire administration’s budget, prepared with the assistance of all the Cabinet Secretaries and under

the guidance of the President and the Office of Management and

Budget.

The President’s budget, which will grow about 4.1 percent per

year, protects Social Security and Medicare, pays down the national debt and provides working families with meaningful, needed

tax relief.

At my confirmation hearing 3 months ago, I identified five key

areas for the Department that are reflected in the budget that we

have submitted today.

And these priorities are obviously: One, to ensure the safety and

health of every workplace; to guarantee an honest day’s pay for an

honest day’s work; to fight discrimination; to protect workers from

coercion and intimidation; and to make sure workers’ pensions are

protected.

And, of course, there is the overriding theme that I have worked

a great deal on, and that is workforce training and development.

The Department of Labor has done a great deal to protect workers, but needs to do more to prepare workers for the new economy,

for dislocations that result from trade, and for changes in skill

needs.

And so to bring focus and drive to this mission, a new Office of

the 21st Century Workforce has been created within the Department. It is funded out of existing resources.

The Department will hold a summit on the 21st Century Workforce on June 20 of this year, where leaders from business, labor

unions, government, and academia will address the fundamental

changes affecting our country’s workforce and economy.

Let me comment a bit about the five goals. The first goal is to

ensure the safety and health of every workplace. There is no question that the Department needs to be in the business of assisting

workers through employers before an accident occurs.

Enforcement is a critical part of the Department’s job. I am fully

committed to that. And OSHA, indeed, has issued about 38 fines

of over $100,000 in the last year. But what I have tried to emphasize also is that after-the-fact enforcement is not going to ease a

family’s grief when a loved one is injured or killed.

And so I would like to put more emphasis on compliance assistance, so that we can truly help workers, to protect them before an

accident occurs. OSHA’s budget request is $426 million for the

2002 fiscal year. MSHA’s is $246 million.

The second goal, of course, is to guarantee an honest day’s pay

for an honest day’s work. And the Department needs to enforce our

common sense laws about labor practices, and not just a reflexive

one-size-fits-all approach.

The Department’s request maintains our worker protection agencies at 2001 levels. We are expanding our efforts in 2002 on compliance assistance activities. And if I can just point out, since 1996,
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the Department has realized a 36 percent increase in worker protection programs.

The Employment Standards Administration, which includes the Wage and Hour division, has a fiscal year 2002 budget of $284 million.

The third goal was to fight discrimination. And we are thankful

to the ranking member to have helped in the establishment of the

Office of Disability Employment Policy.

Mr. Harkin, I know how strongly you feel about that, and we

look very much forward to working with you in making sure that

the mission of this office is totally fulfilled. We have allotted $20 million extra on top of last year’s. And we

expect to have ten FTE’s for this office in 2001. And as you well

know, the President feels strongly about this as well, because of his

new freedom initiative.

The Department also has an important role in worker protection

abroad. And as the chairman mentioned, we do have the Department’s Bureau of International Labor Affairs.

This Department’s program has increased 77 percent over fiscal

year 1999. And for fiscal year 2002, the Department is requesting

a smaller amount of $72 million, but 100 FTE’s for international

labor activities. And I will speak more to that, I am sure, as we

go on this.

The fifth goal is to make sure that workers’ pensions are protected. And I have recently met with Attorney General Ashcroft to

ensure that the Departments of Justice and Labor will work together and to protect our workers’ pension funds. And Pension Welfare Benefits Administration, which guards the integrity of our Nation’s pension funds has a budget request of $108 million.

This pretty much is an overview of the plans for the Department

of Labor. I emphasize once again how important it is for the Department not just to react to change, but try to anticipate them.

We want to help workers adjust to a 21st Century workforce.

And that is why we are spending a great deal of time on training

and development.

There are concerns about the 5 percent reduction in the budget.

And as the chairman has pointed out, a great deal of that decision

was based on the overhang of unexpended funds. We do have an unexpended fund balance of $1.7 billion. Usually, the unexpended funds balance is about $1 billion. So this year, we

have well over $700,000,000.

So while the budget has been cut back, $542 million, that, again,

is more than taken care of by the larger than usual excess from

the previous year.

We are also spending $80 million on new technology to ensure

that the Department is up to speed. We are spending another, I believe, $40 million on BLS to ensure that the Bureau of Labor Statistics is providing up-to-date and truly relevant information. And

it is a wonderful organization.

PREPARED STATEMENT

But I am kind of rambling on, so I will stop here and be happy

to answer any questions.

Senator SPECTER. Thank you very much, Secretary Chao.
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[The statement follows:]

PREPARED STATEMENT OF HON. ELAINE L. CHAO

Mr. Chairman, and distinguished Members of the Subcommittee, thank you for

the opportunity to appear before you today to present the Department of Labor’s fiscal year 2002 Budget.

The President’s 2002 budget moderates the Federal Government’s recent rapid

growth in spending while funding national priorities, paying down the debt, and

providing tax relief. The Department of Labor’s budget request for 2002 follows this

responsible approach and will serve as the foundation for us to become a 21st Century Department of Labor.

Before I discuss the specifics of the Department’s 2002 request, I would like to

highlight a new addition to the Department of Labor. We at the Department of

Labor need to provide a beacon of hope, finding solutions for the problems facing

our Nation’s workers and the economy as a whole. Thanks to the bipartisan work

of Congress, we have a new road map—the Workforce Investment Act—to lead us

toward this goal. Along with states and localities, the professionals in our Employment and Training Administration are diligently implementing this new legislation.

But we need even more fresh ideas, fresh approaches, and new partnerships to help

us succeed in this journey. That is why I am creating within the Department a new

Office of the 21st Century Workforce to bring focus and drive to this mission.

This Office will be funded out of existing resources and its first responsibility will

be to hold a Summit on the 21st Century Workforce on June 20, 2001. At the Summit, I will call on leaders from business, labor unions, government, and academia

to address the structural changes affecting our workforce and our economy.

We need to review every aspect of this Department’s work to ensure that we are

helping, not hindering, the development of a workforce that is ready for the future.

We want to give workers the flexibility to custom-design their work to fit their

lives—and not the other way around. But I want to make clear that this focus on

the 21st Century workforce is about a lot more than just making sure Silicon Valley

has enough engineers. Every worker should have the opportunity for a fulfilling and

financially rewarding career.

Given everything we are setting into motion with our 2002 budget request, our

mission at the Department of Labor must not be just to react to changes, but to

anticipate them and help the Nation’s workforce adapt to them. Better yet, the

workforce should be able to take advantage of those changes. We need to recognize

that the 21st Century economy is not the same one we grew up with and that America’s 21st Century workforce has to adjust. To help people do that—to give workers

constant hope in a changing world—we need to become a 21st Century Department

of Labor.

At the Department of Labor, it is about making sure that no worker is left behind—like those who have been laid off from jobs because their company could not

keep up with technological changes or foreign competition, those who did not get

a full education, or those who made a wrong turn at some point in their lives and

are trying to make it back. And, as the President has insisted, we must reach out

to those who have been denied the opportunity for a productive, meaningful work

life because of a disability. At the Department of Labor, we are prepared to do just

that.

As for our fiscal year 2002 budget, the Department’s overall request is 17,483

Full-Time Equivalents (FTE) and $44.4 billion in budget authority, of which $13.6

billion is subject to the annual appropriations process and is now pending, Mr.

Chairman, before your Subcommittee. The request for discretionary programs is

$11.3 billion in budget authority, which is $564 million less than 2001—with a net

reduction of 184 FTE. In a country experiencing a current skills gap and a longterm worker shortage, this is a budget request that will allow America to achieve

its full potential while still maintaining a responsible fiscal approach with precious

taxpayer resources.

EMPLOYMENT AND TRAINING PROGRAMS

The Department’s fiscal year 2002 budget for Employment and Training Programs

is $6.8 billion. Included in this total is $2.3 billion, which is targeted for employment and training programs for adults—including $1.4 billion for employment and

training activities for dislocated workers. In addition, $2.7 billion is requested for

youth employment and training programs—including $1.4 billion for Job Corps—to

help young people make a successful transition to the world of work and family responsibility.
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This budget represents a net decrease of $474 million from 2001, which is largely due to decreases of $359 million in formula grants related to the availability of large

amounts of State unexpended carryover which can be used in lieu of new budget

authority. I want to be clear, Mr. Chairman: there will be no diminution of service.

We are prepared to serve the same number of participants as in 2001. It is estimated that $1.6 billion in unexpended youth, adult, and dislocated worker funds

will be carried into 2002—approximately $600 million more than what is typically

realized, which is due largely to the implementation of the Workforce Investment

Act.

DISABILITY EMPLOYMENT POLICY

The 2002 budget provides $43.2 million and 67 FTE to fund the Department’s

work toward eliminating policy barriers that impede the employment of people with

disabilities.

A particular highlight for the Department is the new Office of Disability Employ- ment Policy (ODEP). The 2002 budget includes $40.6 million and 57 FTE for ODEP,

an increase of $20.3 million and 10 FTE over 2001, to support key elements of the

President’s New Freedom Initiative in areas that focus on integrating Americans

with disabilities into the workforce.

The increase includes $6 million and 3 FTE to expand one-stop accessibility

grants and support the process of ticket-to-work through One-Stop Career Centers;

an additional $6 million and 3 FTE to build on the Youth-to-Work Grant program

and ensure that young people with disabilities benefit from youth programs under

the Workforce Investment Act; and $8.3 million and 4 FTE for an Olmstead grant

program to assist persons with significant disabilities in making the transition from

institutional settings to the community and employment.

The Task Force on the Employment of Adults with Disabilities will continue its

efforts to create a coordinated and aggressive national policy to bring adults with

disabilities into gainful employment. The Task Force will deliver its fourth and final

report to President Bush by July 26, 2002, the twelfth anniversary of the Americans

with Disabilities Act. The 2002 budget includes $2.6 million and 10 FTE for the

Task Force to complete its mission.

WORKER PROTECTION/COMPLIANCE ASSISTANCE

The Department’s 2002 request maintains our worker protection agencies at 2001

levels, and we are expanding our efforts in 2002 for compliance assistance activities.

An example of prior rapid growth in spending can be found in our worker protection

programs. Since 1996, the Department has realized a 36 percent increase for worker

protection programs, which significantly outpaced inflation. From providing for the

safety of every worker’s pension, to ensuring the safety of every workplace, and from

ensuring that Federal contractors provide equal opportunities to their workers, to

ensuring that all employers comply with the Nation’s wage and hour laws, a responsible fiscal approach will allow us to moderate recent growth in Federal spending

while still realizing the same levels of worker protection.

I want to be clear on what we wish to achieve: we will continue to make administration of labor laws a top priority, but with an eye toward a common sense, flexible

approach that aims to protect workers and help employers comply with the law. To

more effectively and efficiently administer our laws, our worker protection agencies

will be emphasizing more—and better—compliance assistance as our initial strategy

in preventing workplace injuries and illnesses and violations of labor laws.

One example of more and better compliance assistance is the Occupational Safety

and Health Administration’s approach to implementing its new ‘‘Needlestick’’ rule.

We have a proactive strategy to ensure that employers understand this new rule—

which includes extensive outreach and educational efforts before rule enforcement.

This approach will allow everyone involved—the Department, employers, and workers—to focus on the prevention of needlesticks and other similar injuries to workers.

Worker protection laws are only as effective as the degree to which they are understood and followed. By emphasizing compliance assistance, we help both employers and workers understand not only a rule’s requirements but also how best to

avoid the injury or illness the rule is designed to prevent. Each time I hear about

safety violations that were discovered after an accident that cost the life of an employee, I cannot help but feel great sadness. After-the-fact enforcement cannot ease

a family’s grief when a loved one is injured or killed on the job. If we really are

going to protect workers, we must put more emphasis on prevention. By enforcing

laws before injuries or illnesses occur, and by helping employers provide the necessary levels of protection and meet their compliance obligations, we can and will

save workers’ lives.
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LABOR STATISTICS

The 2002 request includes $25 million in additional funding for the Bureau of Labor Statistics, including $8.1 million and 40 FTE for a key step in fundamentally

changing the manner in which the Consumer Price Index (CPI) is revised and updated. For some time, the Bureau has worked to improve the accuracy and timeliness of the CPI. The additional funds requested in 2002 are critical to the continuation of this effort, which has as its goal the production of a more up-to-date CPI

and should substantially reduce the need for large periodic increases like those historically requested.

INTERNATIONAL LABOR AFFAIRS

The Department requests $71.6 million and 100 FTE for international labor activities in 2002. This request recognizes the importance of promoting international

labor standards and reducing abusive child labor throughout the world. I believe the

Administration’s request helps us to effectively balance our priorities on these critical issues while maintaining sensible spending policies.

Our 2002 request preserves the Bureau of International Labor Affairs’ (ILAB) core

responsibilities and allows the Department to integrate activities in ILAB with the

overall foreign policy of the Administration. In this budget, ILAB continues its work

on the global HIV/AIDS initiative begun in fiscal year 2001 and continues bilateral

and multilateral projects to assist developing countries in establishing basic labor

protections, enabling more and more workers to enjoy fundamental employee rights.

UNEMPLOYMENT INSURANCE

The fiscal year 2002 budget includes a request of $2.4 billion for Unemployment Insurance administration. This is an additional $50 million above the fiscal year

2001 appropriation level, to reflect the increased unemployment insurance claims

workload under the President’s economic assumptions. The increase reflects an average weekly insured unemployment (AWIU) rate of 2.622 million compared with

the 2.396 million level set in the fiscal year 2001 appropriations.

ENERGY EMPLOYEES’ OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT

The Department’s budget includes $136 million and 413 FTE for administration

of the Energy Employees’ Occupational Illness Compensation Program. In addition,

$597 million will provide compensation and medical benefits to eligible workers and

survivors.

ADVANCE APPROPRIATION

The Administration proposes to reverse the budget practice of using advance appropriations simply to avoid spending limitations. Accordingly, the amount requested to be appropriated for the 2002 budget is sufficient to provide normal funding, and no advance appropriation is requested. In order to avoid overstating discretionary budget authority in fiscal year 2002, language is proposed to designate the

Department’s advance appropriation budget authority of $2.463 billion as direct

spending. The Administration is committed to resolving this issue in the fiscal year

2002 Budget.

VETERANS’ EMPLOYMENT AND TRAINING SERVICE

For 2002, the Department requests $211.7 million for the Veterans’ Employment

and Training Service (VETS), the same funding level as for 2001. This request includes 250 FTE to accomplish the VETS mission of providing employment and training opportunities for veterans through the public employment service and other employment and training programs, as well as protecting veterans’ employment and

re-employment rights. The 2002 request continues the funding of the Homeless Veterans Reintegration Project at $17.5 million. This program, as authorized by the

Stewart B. McKinney Homeless Assistance Act and title 38, will provide employment and training assistance to homeless veterans, with expected job placements of

approximately 10,000.

INFORMATION TECHNOLOGY

A total of $80 million—an increase of $43 million over 2001—is requested for the

centralized Information Technology (IT) account to fund the Department’s IT investments within four cross-cutting areas: $40.5 million for Enterprise Architecture;

$10.6 million for a Common Office Automation Suite; $19.7 million for Security and

Privacy; and $9.1 million for Common Administrative Systems. This request will
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support the second year of our efforts to replace duplicative and disparate systems

with a coordinated approach to provide centralized information technology investments managed by the Department’s Chief Information Officer. These IT resources

will help ensure program effectiveness among DOL programs and are key to my renewed commitment to compliance assistance through maximum use of technology.

GOVERNMENT PERFORMANCE AND RESULTS ACT

There is a small—but important—amount of $5 million in our 2002 request for

a centralized fund to finance program evaluations, primarily in the Department’s

worker protection agencies. These funds will be used to improve overall program effectiveness and data quality pursuant to the Government Performance and Results

Act (GPRA) of 1993. The Department has made significant strides in implementing

the provisions of GPRA and we believe that funding for program evaluations will

provide data that can be used to further evaluate and improve program effectiveness

and data quality. In addition, the Budget request for the Employment and Training

Administration includes $9 million to evaluate job training programs, including an

evaluation of the Workforce Investment Act’s performance management system.

GRANT ACCOUNTABILITY

$1.8 million is requested to improve the Department’s administration of grant

funds to improve the timeliness, accuracy, and usefulness of financial and performance information. $1.5 million of this increase would go to the Employment and

Training Administration to increase its financial management capacity and

strengthen program management through specialized oversight and assistance to

states and other grantees. The Office of the Chief Financial Officer will use the remaining $300 thousand to develop financial tools for grant programs and provide

added oversight to grantee cost reporting.

FEDERAL EMPLOYEES’ COMPENSATION ACT SURCHARGE

The President’s 2002 budget includes a proposal to amend the Federal Employees’

Compensation Act (FECA) to provide for a surcharge, to be paid by each agency,

to finance the administration of the FECA program. The surcharge will replace the

$80.3 million in budget authority to finance fiscal year 2002 program administrative

costs and will be based on the amount of the workers’ compensation benefits paid

by each agency. The purpose of this surcharge is to boost Federal agency incentives

for improving safety in their respective workplaces.

TRADE ADJUSTMENT ASSISTANCE (TAA)/NORTH AMERICAN FREE TRADE AGREEMENTTRANSITIONAL ADJUSTMENT ASSISTANCE (NAFTA-TAA)

For fiscal year 2002, $415.7 million is requested for the Employment and Training

Administration’s Federal Unemployment Benefits and Allowances. Legislation will

be proposed at a later date to reauthorize the TAA and NAFTA–TAA programs,

which expire on September 30, 2001.

Mr. Chairman, this is an overview of what we have planned at the Department

of Labor for fiscal year 2002. While the President’s 2002 budget presents a responsible approach to meet the needs of America’s workers—including funding national

priorities, paying down the debt, and providing tax relief—it will also ensure that

our Nation’s workers are prepared for the 21st Century workplace.

I will be happy to answer any questions you may have about the Department of

Labor’s budget request.

Senator SPECTER. The balances, which are higher than expected,

would not cover—or would it cover the Youth Offenders, where

there is a reduction of $55 million?

Secretary CHAO. The Youth Offenders has been combined with

another program. And I have Jim McMullen, and Jim is the Deputy Assistant Secretary for Budget and——

Senator SPECTER. That would be fine. We would be glad to hear

his response.

Secretary CHAO. Okay. Basically $20 million has been injected.

The whole program is $75 million over 2 years. That is the short

answer.

Senator SPECTER. Well, to sharpen my question——
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Secretary CHAO. I was afraid of that.

Senator SPECTER. Will the Youth Offenders—we have 5 minutes

for Senators. We do have lights for Senators. That is true.

Secretary CHAO. It is an important program.

Senator SPECTER. Will the program have less money for fiscal

year 2002 than 2001?

Secretary CHAO. Yes.

Senator SPECTER. And——

Secretary CHAO. But over a 2-year period, there will be more. So

this has been—the Youth Offender program has been consolidated

with another program, so that over a 2-year period, there will be

more money and there will be no compromise in the quality of the

program.

Senator SPECTER. What is the other program with which it is

consolidated?

Secretary CHAO. May I ask Jim McMullen to take it?

Senator SPECTER. Yes. That is fine. If——

Secretary CHAO. Okay. Jim.

Senator SPECTER. We are moving into a lot of technical information and we would be glad to have Mr. McMullen supplement your

answers, Madam Secretary.

Mr. MCMULLEN. What we have pending before you right now,

Mr. Chairman, is a reprogramming request in fiscal year 2001 to

move $20 million out of the Incumbent Worker program into the

Youth Offender program, to make it a program totaling $75 million

over the 2-year period, between 2001 and 2002.

Senator SPECTER. Well, so are you saying that with the reprogramming, if it is approved, that there will, in fact, be no cut

in the Youth Offender program for fiscal year 2002?

Mr. MCMULLEN. No. That is not what we are saying. What we

are saying is that we are proposing to increase the amount that

you appropriated in 2001 to spread it over a 2-year period. But

there is no new budget authority request for the Youth Offenders

in 2002. That is correct.

Senator SPECTER. Well, is the program eliminated or simply cut by $55 million in 2002?

Mr. MCMULLEN. It is not eliminated. It is continued through

2002 by this reprogramming request.

Senator SPECTER. And what happens after 2002?

Mr. MCMULLEN. We will address that in the 2003 budget.

Secretary CHAO. I understand your concern.

Senator SPECTER. Well—so I am not following. Will the Youth

Offender program have less money in 2002 than in 2001?

Mr. MCMULLEN. Yes.

Senator SPECTER. How much?

Mr. MCMULLEN. Well, the $75 million is for a 2-year period. So

you had appropriated $55 million. So if you——

Senator SPECTER. Could you skip the——

Mr. MCMULLEN. If you assume——

Senator SPECTER [continuing]. The reasons and tell me how

much?

Mr. MCMULLEN. If you assume the $75 million equally spread over 2 years, it would be $37.5 million.

Senator SPECTER. It’s $37.5 million less?
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Mr. MCMULLEN. No. That is a total——

Secretary CHAO. No. That is a total——

Senator SPECTER. Well——

Mr. MCMULLEN. No. That is a total over——

Secretary CHAO. Right.

Mr. MCMULLEN. $37.5 million each year——

Secretary CHAO. Right.

Mr. MCMULLEN. [continuing]. 2001 and 2002. So——

Senator SPECTER. Is that the appropriation, or is that the reduction?

Mr. MCMULLEN. That——

Senator SPECTER. This is the sixth time I have asked the question.

Mr. MCMULLEN. The appropriation was $55 million in 2001. And

we are proposing to move $20 million more into it to make it a $75

million program to be operated over a 2-year period. If you assumed even——

Senator SPECTER. So $75 million divided by two is $37.5

million——

Mr. MCMULLEN. $37.5 million, right.

Senator SPECTER [continuing]. And if it had been at $55 million, that is a $17.5 million cut.

Mr. MCMULLEN. That would be about a—that is correct.

Senator SPECTER. Which is about a third.

Mr. MCMULLEN. That is correct.

Senator SPECTER. Well, okay. We have the standing to make

some modifications in it, obviously, but——

Mr. MCMULLEN. That is correct.

Senator SPECTER [continuing]. That is a danger signal.

And how about the youth activities at $102 million, which is

being reduced in 2002 compared to 2001?

Secretary CHAO. If I can ask Mr. McMullen to take a look at that

also.

Mr. MCMULLEN. Yes, sir. We are proposing a reduction in the

youth area, assuming that the reprogramming that we have pending before you be reduced by about 13 percent from 2001 to 2002.

Senator SPECTER. So is the figure accurate as provided by my

staff to me, that youth activities will be decreased—second time I

am asking this question—by $102 million in 2002, less than 2001?

Mr. MCMULLEN. Yes.

Senator SPECTER. Well, Madam Secretary, on a priority public

policy matter, what is the justification for that?

Secretary CHAO. I think the President was trying to ensure a

budget that had fiscal discipline, that was able to meet the key priorities of our Nation, protect Social Security and Medicare, and

hopefully also put some money back into the pockets of working

men and women in—of America.

Senator SPECTER. You are not going to tell me that the tax cut

is taking this money. That is going to very materially weaken the

case for the tax cut.

Secretary CHAO. Well, this is the beginning of a dialogue that I

am having with the committee. And so what I am learning, obviously, is the concerns and the priorities of the committee. And so

I appreciate the opportunity to learn about this.
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Senator SPECTER. Well, I really do not think that these cuts do

impact on the tax cut. I just made that comment, when you say

putting money back into the pockets of the taxpayers, which I

think is a good idea.

And we are really looking at an overall budget. And my red light

is on, so I will just make this brief comment and turn to my colleague Senator Harkin.

We are looking at a decrease in budget which is very material, $562 million, and when you have an overall increase that the

President has proposed by four percent—and that may be adjusted

upward.

I do not know what is going to happen. The Budget Committee

has not yet concluded its work. And I realize that you have to negotiate with the Office of Management and Budget. And that is the

executive branch and these figures have to be worked out.

Our interest on the subcommittee level is to try to get, to the extent we can, the administration’s thinking, as we try to establish

a total budget for our subcommittee, which was at about $108 billion last year; and then how we make the allocations to all the departments.

But as I take a look at some of these cuts, I think we will have

some suggestions for you.

Senator Harkin.

Senator HARKIN. Thank you, Mr. Chairman.

Madam Secretary, several years ago, the Department of Labor,

at my urging and Senator Specter’s, began to—began a process of

taking a look at the use of child labor around the globe and how

that was impacting our country and impacting world trade.

The Department of Labor, U.S. Department of Labor, has put out

five volumes. I recommend them to you. You do not have to read

every one of them, but I recommend you at least take a cursory

look at those.

Five volumes over the last—how many years? Seven years,

maybe—about 7 years, on various aspects of child labor around the

globe, including child labor in this country. As that process moved

forward, we began on this committee to take a look at our obligations in the international labor organization and what we might do

to help a program called IPEC, the International Program for the

Elimination of Child Labor.

I felt at that time, and I think a lot of people felt that the United

States ought to stand as a leader, as a beacon to the rest of the

world in terms of eliminating child labor, that we should not just

get along and go along, but that we ought to take concrete action

to help reduce the incidents of child labor around the globe.

To that extent, this committee and, along with the House, began

to increase funding for that program that is called the IPEC, the

International Program for the Elimination of Child Labor. And so

we started putting money into it. And that went up to—the final

appropriation last year was $45 million for that, up from $30 million the year before.

Concurrently, along with that, one of the problems that I have

seen as I have traveled around the world and looked at the issue

of child labor in other countries, is the problem of education, that

you cannot just take these kids and take them out of some of these
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factories and plants and—surgical instruments and clothing and

things like this, most of whom are girls, women, young girls, and

dump them out.

So the—there is a program that was started that was an educational aspect of this program to provide support for educational

programs for these children who were taken out of these plants and

out of these factories in some of these countries.

And so we began a bilateral program with other countries for

education. Now, I have, on my own, seen the results of this in some

other countries and what has happened.

And it really has been startling to see these young girls, some

of them 10, 11, 12 years old, and they have been working in these

plants for 2, 3, or 4 years, since they have been 8 years old. They

do not know how to read. They do not know how to write. They do

not know basic arithmetic.

They have been taken out of these plants. They have been sent

to school. They have been given materials. The families have been

given a little bit of a stipend to replace some of the lost wages.

And if you ever want to have an uplifting experience, go to one

of these countries—I do not need to name them all here—and just

see some of these young girls, who are now 13 years old. And they

can read. And they can write. And they can do basic arithmetic and

math. What has happened to them just in the last 2 or 3 years has

been remarkable.

And so the United States is now taking a lead in this; and I

think for good cause and for good outcomes and to help end the discrimination that we see around the globe on child labor.

Well, we put $45 million in it last year, into IPEC. We added $37

million for the education program. Your budget cuts the IPEC program by, considerably, from $45 million to $30 million, and you

eliminate the educational aspect that we put $37 million in last

year. And it cuts 17 FTE’s in that program.

Well, Madam Secretary, I think this is a vitally important program. It is one that we have been making slow progress on over

the last several years through the Department of Labor. I think the

Department of Labor has moved to the forefront of this.

I believe in the international community, as I have met with

international labor organizations and others, they are now looking

upon the United States as being a leader in the elimination of child

labor and the promotion of educational benefits for these kids.

I think it really is a step backward for us to try to zero this out

and to reduce the funding for it. And I would just like to have your

comments on it.

Secretary CHAO. I would be pleased to. You mentioned visiting

countries in which these child labor practices occur. I have visited

them. I have been with the Peace Corps, and I have visited many

countries. There is no doubt that this is a serious issue, and we all

care deeply about it.

I think the larger issue is whether an office such as International

Labor Affairs Bureau, is able to absorb the money because in 1996,

the budget of the ILAB was about $9 million. In 2000, the funding

was increased to about $76 million. And in 2001, the funding was

increased to about $147 million.
214

That is beyond the capacity of one office to absorb. And one way obviously to absorb that money is to contract out $70 million of it.

I do not know whether that, indeed, is a responsive way of doing it, and certainly you can contract out $170 million or whatever to

organizations overseas.

So please be assured that we are not differing at all in terms of

the goal. We want to work with you on this. The issue is how best

to do so, and how we can work and how ILAB can absorb all this

money in such a short period of time. But the commitment, I assure you, is absolutely there. And we look forward to working with

you on that.

Senator HARKIN. Well, I will work with you on it.

All the indications I have is that this money is well utilized and

they could absorb this increase.

I would be delighted if you want to give me some written documents to show that this money is not being utilized well.

Every indication I got was that it was well utilized and that they

were able to handle this. If you are telling me it was not, I would

like to have some information on that.

I just think to go from $37 million to zero is really turning it—

I mean, obviously they could do more than zero on education.

Secretary CHAO. But the budget of the whole office is the International Labor Affairs Bureau. I think I was asking for clarification

as to the difference between ILAB and IPEC.

ILAB, itself, under which this program falls, has a budget of $74 million that went up to about $140 million. So that is a lot. And

I think that was the absorption issue.

Senator HARKIN. Over 3 years. That is because of IPEC and the

education.

Secretary CHAO. Yes.

Senator HARKIN. So——

Secretary CHAO. And so a large part of that was just contracted

out. And if you want to build the infrastructure, internally, that

will take some time.

Senator HARKIN. But my staff just said—you are talking about

ILAB, but the IPEC program is something that has been going on

for years.

Secretary CHAO. Yes.

Senator HARKIN. This is not something new. It has been going

on for many years.

Secretary CHAO. This is part of ILAB though. And the funds are

fungible.

Senator HARKIN. The program, IPEC——

Secretary CHAO. Yes.

Senator HARKIN [continuing]. International Program for the

Elimination of Child Labor has been going on for a long time. This

is not something new.

Secretary CHAO. I have been told it is new. Let me look into it

for you, and clarify that.

Senator HARKIN. Well, okay. Just——

STAFF. The education part is——

Senator HARKIN. Yes. The education part was new. That is what

we started. I look forward to working with you. I just think it is

not right to be backing off on that right now.
215

Let us see. I just had one other area. According to the OSHA

strategic plan, you specifically cite the Susan Harwood training

grants as one of the main tools your Department intends to use in

OSHA’s mission, which is improving workplace safety and—and

health.

These grants provide funding to non-profit organizations to conduct safety and health training and education in the workplace.

Yet on March 29, you sent a letter to the 2001 awardees, informing them that you rescinded the funding, citing budgetary reasons.

One of the grantees, Kirkwood College in Cedar Rapids, Iowa, had

received a $381,000 award. These grants were funded through the

fiscal year 2001 money that this committee appropriated last year.

Secretary CHAO. Yes.

Senator HARKIN. So, again, I wonder: What are the budgetary

circumstances that necessitated taking this funding away? If, in

fact—you also said that you specifically cited the Susan Harwood

training grants as one of the main tools. Then you send a letter out

saying that you are going to rescind the funding.

Secretary CHAO. Let me backtrack a little bit. These grants were

given on a 3- to 5-year basis. And so the grants were given basically on the basis of an old budget. In our going through the budget

this time, we found that there was not enough money.

So let me just also say I have heard a great deal of concern expressed on this, not only from you, but from other people. I have

received lots of letters. And so that is another area that I will be

looking at.

These grants will not be terminated. We are asking for new solicitations for a 1-year term. So those grants will go forward. Instead of the 3- to 5-year time frame that was being talked about,

we are going to go for 1-year grants and take a look at receiving

applications for 1 year.

We are encouraging people, in fact, to reapply. Although, it will

be a 1-year term instead of 3 to 5 years.

Senator HARKIN. These grants that went out were not 1-year

grants.

Secretary CHAO. No. They were not. They were 3 to 5 years. And

we did not have the funding at that time, which is why we are

going out with a new process.

Senator HARKIN. Okay, explain—let’s take Kirkwood College in Cedar Rapids. They had received a $381,000 award. We put the

money into it. We appropriated the money for that program there.

Now, you write a letter saying ‘‘We are rescinding that money.’’

Why?

Secretary CHAO. Yes. Because it was for a commitment of 3 to

5 years that this administration was not ready to commit to at this

point. So we would like to start the program anew and go out with

a 1-year application process.

Senator HARKIN. But I mean at least the money that went

out——

Secretary CHAO. Yes.

Senator HARKIN [continuing]. Why did you rescind that money?

If you want to do something else next year, come in and do something this year. But as I understand it, you are trying to rescind

this money.
216

Secretary CHAO. Well, people are just restructuring the program

from a commitment of 3 to 5 years to 1 year.

Senator HARKIN. So——

Secretary CHAO. We are encouraging people to apply.

Senator HARKIN. So Kirkwood is going to receive their $381,000

then?

Secretary CHAO. I do not know whether that is a 1-year or a 3-

to 5-year commitment, but we encourage them to apply again for

a 1-year grant. And I certainly would understand your concern

with that.

Senator HARKIN. My staff tells me that Kirkwood got 1-year

money with the possibility that it could be extended beyond that.

Secretary CHAO. Well, they are, again, invited to apply again for

the 1-year grant.

Senator HARKIN. Well, I do not really understand that.

Secretary CHAO. Instead of making a commitment for 3 to 5

years, we are saying: This is a new administration. We would like

to have the opportunity to review some of these grants. But please

apply for a 1-year timetable, instead of a 3 to 5. So that gives us

some time to evaluate some of these grants.

And it is not a political process. I mean, the same people will be

going through it, the same career professionals. So we, in fact,

would like people to apply for a new grant, but just a 1-year grant.

Senator HARKIN. Well, I will take a look at that. I do not know.

I——

Secretary CHAO. And I appreciate your bringing that up to me.

Clearly, you are concerned about that one.

Senator HARKIN. Yes. We have got to take a——

Secretary CHAO. I am very much aware of that.

Senator HARKIN. We have to take a look at that.

Can we go back to ergonomics here for a second?

Secretary CHAO. Yes.

Senator HARKIN. Last week, I asked how much of the budget

would be dedicated to reviewing the—this whole issue of

ergonomics with this—I—and as I understand, what you are doing

is you are moving ahead to develop a new standard.

You said that there was some problems in the rule. It needed to

be more thoroughly reviewed. Okay. Fine. That is certainly that is

your power to do that as Secretary and this administration, because the old rule was done away with.

But as I understand from your statements that you want to move

ahead with a new rule, with looking at a new rule and—and getting information on looking at the problems of the old one.

Okay. If you are going to do that, then it is my understanding

that the budget for the development and evaluation of Occupational

safety standards is cut by $1.2 million. So, again, given your statements that, ‘‘The rule was problematic. We need to thoroughly review it and come up with a new rule,’’ how can we cut the budget

by $1.2 million?

I was asking you also last week how much funding does your

budget allow for review of this issue?

Secretary CHAO. Right. The OSHA standards budget is approximately $14 million. Now, not all of that will be for ergonomics, be-
217

cause it has not been earmarked. But potentially all of that can be

available. So that is the—the overall pot. We have an overlay—you know, an overhang of $1.7 billion. So

a lot of that overlay is going to be funding. Because the cut in the

budget is only $562 million, the larger-than-usual increase in the

overhang of unexpended funds is over $700 million.

So that is why I was saying that enforcement will not be compromised, that none of these programs will be compromised, because, again, we have this overhang of unexpended funds.

Senator HARKIN. My staff informs me that all of that unspent

money is in training, not in OSHA.

Secretary CHAO. You are right. I stand corrected.

Senator HARKIN. So what—okay. Then we come back to OSHA

again.

Secretary CHAO. The OSHA also—some of the decrease also is

because of the cost of living adjustments in terms of FTE’s.

Senator HARKIN. Well——

Secretary CHAO. So that took up some parts of the budget.

Senator HARKIN. Again, Madam Secretary, I want to ask you

again, with all due respect, you know, if we are moving—I am taking you at your word. And I am taking the administration at its

word, since you represent the administration, that you had problems with the old ergonomics rule, that you want to look at the

problems that were in it, and you want to come up with a new rule.

Is that my understanding, or am I wrong in understanding that?

Secretary CHAO. No. I have not committed to any course of action. So I have not committed to a rule.

Senator HARKIN. Well——

Secretary CHAO. I wanted the opportunity to take a comprehensive look at this whole issue.

Senator HARKIN. So you are not committed to coming up with—

because I—we got into a little bit of a debate a week ago about a

time frame. So now you are telling me you are just going to look

at it.

Secretary CHAO. No. I never said that I was coming up with a

rule.

Senator HARKIN. So you are not coming up with a rule.

Secretary CHAO. I am not dismissing it either. But I have never

said that I was going to come out with a rule.

We have been in office basically since February—or January 20.

The C.R.A. did not occur until March 20. So until the C.R.A., there

was an existing rule. So we have had less than a month.

Senator HARKIN. Well, I just—your statement here on March 28

said—you say in your own statement is that, ‘‘However, musculoskeletal injuries accounted for nearly one-third of all the injuries.

This finding demonstrates the need for a solid comprehensive approach to ergonomics.’’

Secretary CHAO. I totally agree with that.

Senator HARKIN. But that does not mean a rule?

Secretary CHAO. Well, I have not decided yet. I am not saying

there will not be a rule either. I think the responsible way to approach it is that there is a new team in town. And I think we have

to feel comfortable with taking the appropriate course of action.

And we need to talk with the administration.
218

Senator HARKIN. Well, unfortunately, I wish I knew what that

course of action was going to be. I mean, I have just——

Secretary CHAO. Well, I cannot——

Senator HARKIN. I mean——

Secretary CHAO. I wish I knew as well. But if I did, I would be

working out of a preconceived position. And I said that I would

keep an open mind and that I would talk to stakeholders, that we

would review the past record, that we would talk to all different

groups.

And, in fact, in my previous testimony, I had talked about certain principles that we would have going forward. And that was basically to go from a basis of prevention. We all agree that reducing

occupational injuries and musculoskeletal injuries is our goal. And

the question is how best to do that.

And I listed six principles. One is prevention. Two is some program based on sound science. Three that it be incentive driven, so

employers would really embrace it as well. Four, some flexibility.

Senator HARKIN. Well——

Secretary CHAO. ‘‘One size fits all,’’ I do not think does it. Five

is feasibility; and six, clarity. So at this point we have not made

a decision.

Senator HARKIN. Well, that is fine, but——

Secretary CHAO. We are proceeding in good faith to address this

issue.

Senator HARKIN. Fine. And every time you are here, I am going

to ask you the same question.

Secretary CHAO. I understand that.

Senator HARKIN. I am going to try to find out when we are going

to start moving on this.

And, fine, if you do not have a timetable now, well, we will ask

it the next time. And we will see when we are going to get some

timetable and move ahead on this.

Secretary CHAO. I understand, yes. I would love to have a timetable. I think that would be very comforting.

But what we have seen on this issue is that when artificial time

lines are imposed, workers do not benefit. None of us benefit

because——

Senator HARKIN. Well, Madam——

Secretary CHAO. I——

Senator HARKIN. Madam Secretary, also workers do not benefit

when this dribbles along year after year after year, and nothing is

ever done.

Secretary CHAO. But we are not talking about years, obviously.

Senator HARKIN. More injuries continue to happen. More people

suffer. And so if I get my druthers, I would rather have a time line

because it forces people to do something and get something done

by a certain time. But if you do not have time lines, it just dribbles

on year after year after year.

Secretary CHAO. I understand exactly what you are saying. I am

very concerned about it. If I may just add one last thing, we had

a time line before with the previous administration and it did not

work. So I want to make sure there is not a repeat of any action

that can be reversed.

Senator HARKIN. Mr. Chairman.
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Senator SPECTER. Thank you very much, Senator Harkin.

Madam Secretary, on the worker protection line, the President’s

budget maintains the activities at last year’s dollar level, but as a

result of inflation, there will be a reduction in staff enforcement.

That leaves less staffing than is in effect for this fiscal year for

OSHA enforcement, mine, safety and health administration, and

employment standards administration.

Is it not, simply stated, a bad idea to reduce staff on those very

important lines of enforcement?

Secretary CHAO. I said before—I am trying to answer the question directly. There is no question that we are for enforcement. And

in looking over this budget, there is no compromise to the quality

nor the intensity of enforcement. We are going through all of these

reductions through attrition.

And also I think one has to make the assumption—one has to

look at whether these positions were the right numbers to begin

with. And so we are committed to going through, looking at the

numbers to see whether this, indeed, is the enforcement that we

need, but there is no lack at all in commitment—in backing down

in commitment on enforcement.

Senator SPECTER. Well, Madam Secretary, when you say you are

committed to enforcement, there is no showing that there are too

many people in these enforcement lines. And if you reduce the

number, the enforcement is, simply stated, going to suffer. Well, we

will take a look at that too, but that is a big problem.

We have already gone over the cuts in the job training programs,

the youth program, the Workforce Investment Act, and the dislocated worker programs. We will review those here.

Let me take up a different subject with you on medical resident

work hours. The Federal Government limits the number of hours

that truck drivers and airplane pilots can work, among others. And

there is a big issue on medical resident work hours, where physicians work up to 80 hours a week, without a day off, and sometimes more than that.

And there is a good bit of evidence accumulating about sleep deprivation associated with these long hours resulting in automobile

accidents, depression, and giving birth to premature infants. I am

reading a list of the factors, which have been called to the subcommittee’s attention.

And then you have the basic problem of people who are being

treated by these residents who are, simply stated, groggy, and simply cannot perform.

There was a petition filed on April 30 to OSHA from healthcare

professionals seeking a Federal limit on the number of hours medical residents can work. What do you think?

Secretary CHAO. I just learned about the petition on Monday, so

I have not had an opportunity to review it. Obviously, if the Chairman is concerned about it, I am concerned about it. And I will take

a——

Senator SPECTER. Well, perhaps we ought to have a hearing on

that specifically. I realize that it has just been filed and there is

always a reluctance to increase Federal jurisdiction. Especially

when you talk about hospitals with the Balanced Budget Act, their

economies and sort of an unwritten code that if you want to be a
220

high and mighty doctor, you have got to suffer a lot going through

on the resident process, and the argument is made that they make

up for it later.

But this is a real problem for those who are going through it.

And it is a real problem for people who are in hospitals that received their services.

Secretary CHAO. I might also add, probably we have to talk to

HHS about this as well.

Senator SPECTER. Turning to still another subject, there has been

a long-standing problem with the Amish—a good many of whom

are in Lancaster County and are constituents of mine—on an effort

to have Amish youth, 14 to 18, work in sawmills.

The House of Representatives has twice passed legislation to

allow that. We have had legislation pending in the Senate, which

I have introduced. What I would like you to do is to take a look

at that.

It is a fairly involved and fairly technical subject, unless you already have a view on it. Tell us what you think about that.

Secretary CHAO. I am very sympathetic. And, obviously, as I

have said before, concerns by members resonates strongly with me.

I will take another look, but the preliminary response that I have

gotten from Wage and Hour is that this has to be a legislative fix.

Senator SPECTER. It has to have a legislative fix?

Secretary CHAO. Yes, and that they do not have very much flexibility in reinterpreting that.

But on the other hand, I do not have my solicitor in place or lots

of other people in place. I will take another look.

Senator SPECTER. Well, take a look. It is a little early for you to

really be expected to have a comprehensive view of that, but it

would not be unkind to say that it may be a bureaucratic response

to say there has to be a legislative fix.

Secretary CHAO. Well, I am hoping that, you know, as I get my

team staffed up, that we will be more responsive, and we will be

able to answer a whole host of questions.

Senator SPECTER. The President has a lot of discretion. And he

has delegated that discretion to the Secretary of Labor, so let us

take a look.

Secretary CHAO. I will do so.

Senator SPECTER. I think administratively would be a much better way to handle that.

My red light is on again. So I am going to yield to my colleague.

Senator Murray.

Senator MURRAY. Thank you very much, Mr. Chairman.

And, Secretary Chao. Welcome. It is good to have you here, and

I am—let me just say at the beginning, I am encouraged by what

I see in your Department’s proposed budget.

Increasing funding for the Department by $5.2 billion, I think, is

a positive sign in providing adequate resources for programs like

Job Corps and funding for the Office of Disability Employment Policy and other critical assistance programs, I think, is essential.

I am concerned, however, about some of the decreased investments for job programs that help at-risk youth and funds employment and training activities for dislocated workers.
221

And let me start by asking you about at-risk youth. I think we

all know that the job requirements, the education requirements,

the training requirements for our work force have changed dramatically in the last decade. And today, more than ever, our workers need more education and training to develop the skills they

need for the—the jobs that are out there today. And I am really very concerned that your budget provides $222

million less for youth employment and training programs. We cannot leave young people out of our country as we move forward. And

I would appreciate it if you would address that cut in your budget.

Secretary CHAO. There is no commitment, obviously, to backing

away from helping youths at risk. It is an issue that I feel strongly

about, and I have worked with in the past. I mentioned before that there was about $1.7 billion in unexpended funds. And the usual carryover is about $1 billion. So we

have an extra $700 million. The cuts from the budget is only about

$562 million. So the carryover still takes care of the overall reduction.

The youth carryover is about $480 million, so we can maintain

the service levels.

Senator MURRAY. The carryover from last year’s budget?

Secretary CHAO. So we, again, do not expect any diminution of

service or commitment, obviously. But that we believe that we can

maintain the service levels.

Senator MURRAY. Were those funds that were appropriated and

not spent?

Secretary CHAO. Yes.

Senator MURRAY. I hope then that you have a commitment to

make sure that those grants and opportunities move out there for

our young people. There is a high increasing demand for that.

Secretary CHAO. We will do so.

Senator MURRAY. Okay.

Secretary CHAO. And there is also a reprogramming request of $20 million that makes for a 2-year budget request of $75 million.

So we went over that a little earlier. But participants will not go

down because, again, the number of participants will not go down

and the quality of the program will remain undiminished.

Senator MURRAY. I think it is—good. Yes. I think it is really important that we emphasize that we do not want to see our kids on

the street with no skills.

Secretary CHAO. Yes.

Senator MURRAY. Second, I am very concerned about dislocated

workers. In my end of the country, we have seen a lot of dislocation, unexpected, in the last year or two, particularly with the current energy crisis that has shut down some of our mills and aluminum companies and threatens more, very—in the very near future. We have seen over 2,000 layoffs at this point and we will be

seeing more.

Boeing has had some layoffs. Our high-tech industries are not

employing and—and having layoffs. And I am very concerned that

your budget has decreased adult employment and training programs by $257 million.

I think the demands for these dislocated workers are increasing.

And if you could address that, I would appreciate it.
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Secretary CHAO. There is also some talk about a softening economy, so this is obviously an area that we are concerned about. We

want people to be able to find assistance.

The dislocated workers program, again, is one of those programs

that we do not expect any diminution of service nor quality, because of excess funds from the previous years.

I know that in your particular State, you have got special concerns. And I will be more than glad to work with you on those concerns, as well.

Senator MURRAY. Okay. I would really appreciate your doing

that, because we are seeing a lot of dislocation. We are going to see

more. And we want to make sure that these people land. So I

would very much like to work with you on that.

In a place where we are seeing a lack of workers is the nursing

shortage that we are currently seeing that I am very concerned

about. Our healthcare facilities, our long-term facilities are very

concerned about the lack of healthcare workers that are coming

into—into that.

And we are currently working in the Senate now on legislation to provide $500 million a year for the next 3 years in grants to

States to promote the nursing profession and to help long-term care

providers, to recruit and train and retain caregivers at all levels.

Would you be supportive of that kind of an approach?

Secretary CHAO. I have talked a lot about the skills gap. I think

this is clearly one example. So I have set up a new office called the

21st Century Workforce. And this is one of the areas that we are

going to address, for example, at the summit that we are holding

on June 20, and as we go forward as well.

Senator HARKIN. Okay. Well, Secretary Thompson testified before the committee last week that part of the solution might be tied

to allowing more foreign nurses and healthcare workers to immigrate to the United States to help fill that void.

Would you be willing to work your Agency with his to talk to the

Department of Justice and Immigration and Natural Service to try

and enact something like that?

Secretary CHAO. We would be interested in exploring this option

further with him.

Senator MURRAY. Okay. I think it is important that we look at

all ways to meet that need.

Secretary CHAO. Right.

Senator MURRAY. So I encourage you to do that.

On an entirely different topic, I want to talk about asbestos for

a minute. Most people in this country think that asbestos has been

banned and they do not have to worry about it. But asbestos has

not been banned in this country and in some cases, it is still being

used to manufacture automotive brakes and roofing materials.

And we are seeing it show up in consumer products like crayons,

garden fertilizers and insulation. Because asbestos is a contaminant found in deposits of other minerals, that is why we are seeing

that.

Evidence has suggested that workers have died from exposure.

The case in Libby, Montana, where 192 people have died has been

very prominent in the news. And 375 people are currently suffering

from fatal diseases caused by that exposure.
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I was curious whether you were familiar with the Inspector General’s report on MSHA’s handling of inspections in the mine in

Libby and with the recommendations that are in that report.

Secretary CHAO. The I.G. has handed that report to me about, I

would say, 3 weeks ago. We are in the process of going through

that.

I do not have an MSHA administrator yet. He has been announced and nominated. We hope that he will be confirmed soon,

so that he can tackle this issue as well.

Senator MURRAY. Well, when he is in place or even before, I

would like to work with your Agency to make sure that we address

that and implement the recommendations that require rule—rulemaking as quickly as possible.

And I see that my time is up. Thank you.

Senator SPECTER. Thank you very much, Senator Murray.

Senator Harkin, do you have one more question or——

Senator HARKIN. Just one more question.

Just picking up on what Senator Murray was talking about on

the employment and training money that you said there was this

carryover. First of all, I understand that the amount—that even

though you have a large carryover, the amount varies per State.

Secretary CHAO. Yes.

Senator HARKIN. And so dislocated worker funds go to States on

a formula basis.

Secretary CHAO. Right.

Senator HARKIN. Therefore, every State will take the same percentage cut even though some States may have a big carryover and

some States may not have much carryover.

Well, here is the point I am getting to: My staff at my direction

requested an analysis, because I wanted to know what was happening in Iowa, obviously, my State. I wanted an analysis of the

unexpended carryover funds in employment training programs by

State. About a month ago, my staff requested this breakdown by

State.

They were told by your staff that a table—there was a table. We

have asked repeatedly as late—as late as yesterday to get this, but

your Department will not release it. So I am asking: Will you release to me the information that will allow us to understand the

impact on the cut to my State—and our States?

Secretary CHAO. I see no reason why you cannot have that at all.

So I am not aware of that request. But you will have it.

Senator HARKIN. If you can get that, because I would like to see,

because it does vary State by State.

Secretary CHAO. Sure.

Senator HARKIN. And if you are going to take a cut that is percentage, some States may be fine. Some States may not be fine.

And I think we, as appropriators, need to take a look at that. And

I would appreciate it.

Secretary CHAO. I think that is a very reasonable request.

Senator HARKIN. I appreciate it. Thank you very much, Madam

Secretary.

Thank you.

Senator SPECTER. Thank you. Thank you, Senator Harkin.
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Madam Secretary, the hearing that we had on last Thursday on

ergonomics showed a very, very deep split between some segments

of the business community and those representing the workers.

And I know your schedule precluded you from attending the full

hearing, but we have given you the transcript. We ordered expedited transcripts so that we could take it up today.

Do you think that there is any realistic likelihood that there can

be a consensus on an ergonomics rule?

Secretary CHAO. No, I do not; 100 percent consensus, no. But I

think there has to be some critical mass upon which to move forward because without that critical mass, I do not think any program is going to be successful.

So I am keeping an open mind and I do not have any preconceived notions. I am keeping all options open. As I mentioned

in my letter, it may include rulemaking. I have not ruled anything

out. I have not made a final decision.

We have only had since March 20 when the C.R.A. was pleased

to take a look at this. And I can assure you that we are proceeding

with full speed and with absolute seriousness and intent to try to

address the ergonomics and musculoskeletal injuries.

Senator SPECTER. When you say that you are proceeding at full

speed, precisely what are you doing?

Secretary CHAO. We are meeting with—well, this is a new team

also. And I think we need to be given time to, No. 1, meet with

the shareholders, and go through the past record.

In terms of making up a new rulemaking, we cannot go back to

the previous record and draw—well, there is some question as to

whether—and you know better than me. There is some question as

to whether we can go back to the previous record and just utilize

the information of the previous record, because there were issues

expressed about, not only the substance, but also the process.

So I think at the very start, we need to go back and talk with

all the stakeholders. I think we have done a good job. We have met

with multiple groups in an effort to listen to everyone, first of all,

and then try to craft some program for moving forward that will

not be stymied right from the outset.

Senator SPECTER. Well, Madam Secretary, I think it is reasonably clear that you can go back and look at the information which

was compiled before.

Secretary CHAO. Yes.

Senator SPECTER. You are going to have to satisfy yourself as to

an evaluation of it and to have an opportunity for people to comment about it. But you can take a look at what has been presented

in the past.

Secretary CHAO. That is true.

Senator SPECTER. This subcommittee wants to, in its oversight

capacity, monitor what you are doing on a time line.

I take it from your response to Senator Harkin’s question that

when I asked you to go back and take a look to see if you could

give us a time line or a concluding date, that you have thought

about that but do not think you can give us a target date.

Secretary CHAO. I would love to, if I could, but I just do not think

I can. I do not think that is a responsible way to approach it. I am
225

not going to drag this out. I can assure you of that. But I think

for me to come out with a deadline would be very irresponsible.

Just to let you know, we have met with United Commercial Food

Workers. This was in my testimony last time. We have met with

the AFL–CIO, Service Employees International Union, United

Brotherhood of Carpenters and Joiners. We met with a lot of labor

groups, a lot of—American Occupational Therapy Association, Food

Marketing Institute, certainly on the other side, American College

of Occupational Environmental Medicine.

So we are conducting our due diligence in meeting with these

various groups. We are going back to the record. There were 11,000

comments on the old rule in just a 12-month period. We are not

obviously going to go through the whole thing, but there have been

criticisms of the process.

And while we can go back, obviously, and take a look at the previous record, there has been some criticism as to whether that

record is inclusive of other types of information.

And also there have been concerns about—comments were submitted by citizens, you know, that were farmed out, paid outside

consultants. I mean, this is pretty—this is a very complicated

issue. It is very complex.

I am not interested in slowing it down, but I do want to do it

right. And, again, I want to do it right because we have got to do

the right thing; otherwise, another overturned action can occur.

And I am not so sure that benefits anyone.

Senator SPECTER. Well, I daresay that something that the Bush

administration comes up with is not likely to be overturned. The

action by the Congress was highly unusual. And I supported overturning the regulation, because I thought it was excessive and others did too, where there were some expressed commitments made

by legislators, by Senators that there would be a new rule.

Now, they do not bind you, but this is something we will be talking about within the Senate, where we have a lot of experience on

this issue. And the people who were strenuously opposed the rule

were able to persuade a number of us to vote to overturn that rule

on the representation that there would be a new rule.

Now, I understand the articulation you have made. And they do

not bind you, but we are all players in the process, and we all have

a role in the process. And those who made those representations

to secure votes on the Senate floor have some impact and some

weight.

Let me raise a question as to your use of the term ‘‘irresponsible’’

to come up with a——

Secretary CHAO. Well, let me answer the previous point. If other

people have made representations, then those are the people that

should—that should be—that this matter should be discussed with.

I stated very plainly in my letter that I was not ruling out rulemaking, but I was not committed to it either. So, again, if there

are other people who made other representations, then they should

be talked to.

Senator SPECTER. Well, you can bet they are being talked to. You

can be sure of that.

I have already made it abundantly clear that I understand they

do not bind you. There is this doctrine called separation——
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Secretary CHAO. I am very interested in having a good relationship with this committee and especially with the chairman and the

ranking, so I hope you will realize that I will—I am looking at this

from a long-term point of view. I would never play any short-term

games or anything like that. And I hope that you understand that.

Senator SPECTER. Well, I was about to say I understand the doctrine of separation of powers and that you are an Article II officer,

and we are Article I officers. And we do not really rate very high

anyway.

Secretary CHAO. That is not true at all, not——

Senator SPECTER. Since——

Secretary CHAO. You rate very high in my book.

Senator SPECTER. Since Marbury v. Madison, neither Article I

nor Article II officers rate very high. The Court decides everything

these days.

But I was starting to raise a question about the use of the word

‘‘irresponsible.’’ To say that it would be irresponsible to accept a

time line when the subcommittee is pressing for a time line, I question that characterization.

I do not think we are asking for something which is irresponsible. There is——

Secretary CHAO. I think that it is irresponsible on my part. It is

not to say that there is any—that is not to attribute that to anybody else but me.

Senator SPECTER. Well—but if the subcommittee is asking for a

time line, and a time line is irresponsible, somebody might raise

the inference that we are asking for something which is irresponsible. So I just——

Secretary CHAO. And I certainly did not imply—I did not mean

to imply that.

Senator SPECTER. I just question the use of the word ‘‘irresponsible.’’ Unrealistic, impossible, difficult—‘‘irresponsible’’ is a word

that has a lot of——

Secretary CHAO. I will use one of the other words from now on.

Senator SPECTER. I know you are familiar with Senate bill 598,

which proposes legislation to establish a time limit of 2 years for

the enactment of a rule. What do you think about Congress telling

you that you have 2 years to make a rule?

Secretary CHAO. I know that you are a co-sponsor of that.

Senator SPECTER. Senator Harkin is not, though. He is still safe.

Secretary CHAO. I know that you are a co-sponsor of that and,

obviously, we are very cognizant of the amendment. We are working with—we would like to work with Senator Breaux and the

sponsors on this.

A 2-year time frame, as told to me by the career professionals in

the Department, is unrealistic. It is very hard to say pro forma how

long a particular rulemaking would take. But 2 years for this kind

of rule seems overly ambitious. But, again, we want to be in discussion on this issue.

Senator SPECTER. Well, okay. I mentioned the bill, because the

Breaux bill does set a time limit. And it is possible that bill could

be enacted.
227

And my preference would be not to have the time limit come

from the Congress. My preference would be to have the time limit

come from the Secretary.

So I would ask you, on behalf of the subcommittee and the committee and the Senate and the Congress to take another look at

this issue to see if you cannot give us some idea as to how long

it is all going to take.

Secretary CHAO. I will certainly do that. Let me also say, you

know, given all the pressure that I am under, it would be a lot

easier for me just to give a deadline. It would make my life a lot

easier. It would make a lot of—certainly, would make my life a lot

easier.

But I have been there for, again, for 3 months. I want to do the

right thing. I do not have an OSHA administrator yet. I have only

got two people that are confirmed in the Department.

You know, Mr. Harkin was talking about responsiveness from

the Department. The career professionals are wonderful. I devote

a great deal of time cultivating the relationship with them. But we

are a new team. We want to be responsive. We are not there yet.

I fully understand that.

But as we get staffed up, as we get more familiar with some of

these issues, I hope that you will think that we are responsive as

well.

But, again, let me say, from a personal pressure point of view,

it would be so much easier for me to say, ‘‘I can give you a deadline.’’ But, again, I do not think that that is something that will

benefit any one of us in promulgating a truly good program.

So let—and as I have said before, I want to work with you and

also Senator Breaux on this amendment. And so my staff, I believe,

has been talking to all of you. And I would hope that that will continue.

Senator SPECTER. Madam Secretary, we have taken a look at the

plans at Levi Strauss, Xerox, Consolidated Edison, United Auto

Workers, all of which have put ergonomics programs into effect

with very beneficial results.

One of them, Xerox, had a 24 percent decline in the number of

worker’s compensation cases. So we would commend to you what

is going on in the private sector as a model.

Secretary CHAO. Yes.

Senator SPECTER. And we understand UPS also has done some

good work. And we have written to UPS. And the point was made

that some of the companies have not responded to the Department

of Labor, like UPS, on giving them the benefit of their thinking and

their successes. And this subcommittee is in a position to help you.

Do you——

Secretary CHAO. Well, I appreciate that.

Senator SPECTER. Do you know if you have the subpoena power

to compel, say, a company to come forward and tell you what their

experience has been?

Secretary CHAO. No, I do not. But I think that is a pretty bad

example, if we have to compel them. I am not so sure their results

were—what—are ones that I want to hear.

Senator SPECTER. Well——
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Secretary CHAO. We are looking at best practices and we are interested obviously in finding out what the private——

Senator SPECTER. Well, if a company does not respond to what

their experience has been, the Congress is not reluctant to issue

subpoenas. And I do not know what——

Secretary CHAO. I will certainly find out if we do have the authority to do that.

Senator SPECTER. I do not know whether you do, but this subcommittee would have no reluctance to find out what companies

are doing.

Secretary CHAO. I have no reluctance either. I was making a little bit of a—of levity, which was probably not appropriate. But I

was going to say that if they did not want to share their results,

I am not so sure they are worthy to be shared. But your point is

a very good one about the subpoena.

Senator SPECTER. Well——

Secretary CHAO. And I will find that out.

Senator SPECTER. Well, I do not know that UPS has not responded. That representation was made. Whether it is so or not,

I do not know. We are making an inquiry.

Secretary CHAO. And we are talking to other companies on best

practices.

Senator SPECTER. Okay. But these companies which have experience, which would be useful to the Department of Labor, I expect

them to make it available.

Secretary CHAO. Yes.

Senator SPECTER. And if they do not, this subcommittee has subpoena power. And I have had some experience at issuing

subpoenas——

Secretary CHAO. Yes.

Senator SPECTER [continuing]. And effectively. So I want to help

you.

Secretary CHAO. Thank you.

Senator SPECTER. Madam Secretary, we are going to give you

some questions from Senator Stevens for response in the record.

My final question to you—or let me not put it in the form of a

question.

I would like for you to give this subcommittee a periodic report

as to what you are doing, since we have not gotten to the point of

a time line. I would like you to let us know every 90 days, if that

is not too burdensome. I was thinking about 60 days, but let us

make it 90 days, if you could give us a brief summary as to what

you have done on the ergonomics issue.

Secretary CHAO. I would be delighted to.

Senator SPECTER. Okay.

Secretary CHAO. Let me—may I also add one last thing?

Senator SPECTER. Sure.

Secretary CHAO. Going back to the Youth Offenders program, let

me also take another look at that, because my understanding was

that the participants would not go down because of the carryover

funds. And so if that is not the case, then I will take a look.

But that—my understanding was that the quality of the program

was not going to be diminished, and number of participants will
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not go down—again, because we had this excess funds. But if that

is not the case, I will get——

Senator SPECTER. Well, that is an especially important——

Secretary CHAO. I will get back to you on that.

Senator SPECTER [continuing]. Important program. When you

talk about rehabilitation, if we do not do it with the Youth Offenders, it is just a revolving door and recidivism. And that is a critical

point of intervention.

Secretary CHAO. Right.

Senator SPECTER. So I appreciate your taking another look at it.

Anything you care to add, Secretary Chao?

Secretary CHAO. I think that is it. Thank you for having me.

Senator SPECTER. Mr. McMullen, I will give you more of a speaking part here.

Mr. McMULLEN. Nothing to add, sir.

ADDITIONAL COMMITTEE QUESTIONS

Senator SPECTER. Thank you very much. There will be some additional questions which will be submitted for your response in the

record.

[The following questions were not asked at the hearing, but were

submitted to the Department for response subsequent to the hearing:]

QUESTIONS SUBMITTED BY SENATOR ARLEN SPECTER

COMPANIONSHIP SERVICES

Question. What is the Labor Department’s plan regarding the Clinton Administration proposal to change the rule on ‘‘companionship services’’ under the Fair Labor

Standards Act, specifically regarding an analysis as to the impact on the elderly and

the disabled?

Answer. The rulemaking proposal was published on January 19, inviting comments for 60 days. Because of the continuing interest expressed in the proposal and

in response to requests, on April 23 the Department reopened and extended the

public comment period for 90 additional days (until July 23). The background and

history to the statutory provisions covered by this rulemaking, as well as its perceived impact on recipients of companionship services, will be carefully reviewed. In

addition, all public comments received on the proposal during the extended comment period will be given very careful consideration before reaching any final decision in this matter.

Question. Regarding the proposed rule on companionship services, has the Department given full consideration to the impact of the change on Federal and State programs that pay for much of the care that will be affected by the proposal? If the

costs to provide the care go up, will the costs go up to the Federal and State programs that pay for these services?

Answer. HCFA previously estimated that the proposed rule would have a negligible effect on Medicare costs, as this service is not a significant component of

Medicare. Annual Medicaid program expenditures may increase somewhere within

a $30 million to $40 million range, of which 57 percent would be the Federal share.

Assuming an equivalent magnitude of increase in the private sector would suggest

the maximum possible combined (public and private) increase of no greater than $75

million. (See preamble of regulatory proposal, at 66 Fed. Reg. 5486, January 19,

2001.)

Question. If this rule is implemented, will it exacerbate the shortage of this workforce as workers may be restricted to less than 40 hours per week to avoid obligations for overtime compensation?

Answer. Implementing the proposed rule is not expected to exacerbate any workforce shortage in this industry. To the contrary, improving the wage structure to include minimum wage and overtime protections may contribute to attracting additional workers to this industry.
230

Estimates from the home care industry indicate that most workers in this industry are not working overtime hours, on the average. The data also indicate that

there are many low-wage workers in this industry.

HARWOOD GRANTS

Question. I am troubled by your Department’s recent decision to withdraw a number of OSHA’s ‘‘Susan Harwood’’ Grants. This action will have a significant negative

impact upon efforts nationwide to curb devastating workplace injuries. Particularly,

I am advised that the Graphic Communications International Union Locals within

Pennsylvania will lose a grant for $296,000 per year for five years and would be

forced to stop offering their members training via the safety and health program

that is now being funded by this grant. Please provide me with your justification

for withdrawing these grants.

Answer. I can appreciate that there are disappointed groups in your State. The

Pennsylvania Foundry Association in Plymouth Meeting, Pennsylvania, was affected

by the decision to rescind the grants. However, the funding for the Graphic Communications International Union Locals is unaffected. They were not one of the 19

groups whose grants were rescinded.

In reference to the decision affecting the 19 groups: we did not believe that we

should commit to higher cost long-term grants of 3 to 5 years. These grants, which

were approved during the last month of the previous Administration, are larger and

longer-term grants than have typically been awarded under this Program. In choosing among many competing priorities for funding, the Department concluded that

it was preferable to provide targeted, short-term grants and maintain Departmental

flexibility to respond to emerging safety and health issues. Therefore, OSHA will revert back to one-year grants in targeted subject areas.

We published a new solicitation under the Susan Harwood Training Grants program on April 18, 2001. Grants will be tailored to provide short-term targeted training in: (1) construction; (2) bloodborne pathogens; (3) ergonomics; (4) electrical power

generation; and (5) training programs for hard to reach workers. We have specifically asked prior applicants to reapply for grants under the new solicitation. I will

ensure that, in fiscal year 2001, OSHA awards fully the $11.2 million available for

training and education grants. These grants will be geared to our team’s strategic

plan and new approach to safety and health of the Nation’s workers.

As I stated when I was sworn in, ‘‘If we are going to protect workers, we must

put more emphasis than ever before on prevention and compliance assistance—rather than just after-the-fact enforcement.’’ As you know, the Harwood Training grants

are but one of many compliance assistance tools used by OSHA. Others include onsite consultation, training provided by the OSHA Training Institute and its affiliates, and easy-to-use interactive electronic tools to help employers and workers understand and comply with OSHA standards.

OFFICE OF THE 21ST CENTURY WORKFORCE

Question. Tell us about your plans to create, with existing funds, a new ‘‘Office

of the 21st Century Workforce’’. Where will the funds come from to create this new

office? What do you anticipate this new office will accomplish?

Answer. The mission of the Office of the 21st Century Workforce is to ensure that

every worker has the opportunity to pursue fulfilling and financially rewarding careers and to make sure that no worker becomes a casualty of the global economy

of this new millennium. Its initial mission is to address our current skills gap and

worker shortage. Funding for the permanent staff of the Office is from the Office

of the Secretary’s Departmental Management account.

TRANSITIONAL LIVING PROGRAM

Question. You are requesting $8.3 million for a new grant program to assist persons with significant disabilities in making the transition from institutional settings

to the community and employment. This sounds very much like the $50 million program of the Health Care Financing Administration at the Department of Health and

Human Services. Are there are any differences?

Answer. Yes, the two programs are different in that they would be focused on providing different types of services even though they are focused on the same target

group—individuals with disabilities who are making the transition from institutional settings to the community. The two programs would be designed to complement, not duplicate, each other.

The Department of Health and Human Services’ (HHS) $50 million grant program

is for support services. These grants will promote the design and delivery of home

and community-based services that support people with a disability or long-term ill-
231

ness to live and participate in their communities. The HHS grants will focus on

meeting housing needs, personal assistance, expanding public-private partnerships

to meet long-term needs, technology, and technical assistance. The United States

Supreme Court’s Olmstead decision, which is the basis for the HHS grants, clearly

holds many implications and opportunities with respect to employment opportunities for people with disabilities. However, the HHS grants do not specifically target

the employment and vocational needs of individuals transitioning from institutions

to their communities.

The proposed $8.3 million for a DOL Olmstead grant program would support the

educational and professional development of individuals with disabilities. The grant

program would provide funds to build professional competence within the workforce

system to be able to effectively partner with other systems so that movement of people from institutions to the community includes planning for their employment. We

plan to work closely with HHS and other relevant agencies, such as the Department

of Education and the Department of Housing and Urban Development, to coordinate

with and complement their efforts.

INFORMATION TECHNOLOGY (IT) CROSS-CUT BUDGET

Question. You have requested more than double the funding of information technology at the Department of Labor from $37 million to $80 million. What do you

anticipate that increase in funding will accomplish? Is this increase in funding to

be expected in subsequent budgets?

Answer. The central IT fund comprises cross-cutting initiatives to comply with

laws like the Clinger-Cohen Act and which benefit the entire Department. These initiatives fall into four categories:

Security and Privacy.—This necessary component includes security planning and

plan implementation, risk management and mitigation, contingency planning, installing firewalls and intrusion detection systems, and related support contracts.

Enterprise Architecture.—This focuses on upgrading the Department’s outdated

core infrastructure, a necessary step to implement the Department’s IT Architecture. Investments will be made in Local Area Networks (LANs), software, cabling,

and telecommunications equipment.

Common Office Automation Suite.—This moves the Department to a single suite

of office automation tools (word processing, spreadsheet, graphics, e-mail, database)

to permit full interoperability among DOL agencies.

Common Administrative Systems.—We must also address applications that are

used by most or all DOL agencies, such as Human Resources, Payroll, Travel, and

inventory management functions.

Together, these initiatives are designed to ensure an integrated, Department-wide

approach to IT investments in support of the Department’s missions, goals, and objectives. Compliance with Section 508 of the Rehabilitation Act also has been built

into the IT cross-cut budget. The initiatives are managed in accordance with DOL’s

IT capital planning and investment control process.

The increase in funding will support an IT infrastructure capable of supporting

E-government objectives, the implementation of our common office automation suite

strategy, a more secure IT environment in accordance with the Government Information Security Reform Act, and implementation of applications supporting enterprise-wide administrative functions such as financial and human resources. The

only department-wide IT fund, this approach has been identified as a ‘‘best practice’’

by the Office of Management and Budget (OMB).

These IT improvements are ongoing initiatives and are essential to help the Department be as responsive as possible to the needs of workers and to secure its data

and IT resources. We have not, however, made decisions on future budgets.

OSHA, MSHA AND ESA STAFF REDUCTIONS

Question. Your budget request would maintain funding for OSHA, the Mine Safety and Health Administration, and the Employment Standards Administration at

essentially current levels. Due to the impact of inflation, this would reduce staffing

at OSHA by 94 full-time equivalent positions, 47 mine safety positions, and 93 jobs

at the Employment Standards Administration. Is this justifiable? Are these agencies

currently overstaffed? Is it your intention not to hire the additional enforcement

staff approved by Congress for fiscal year 2001?

Answer. Worker protection budgets have increased significantly during the last 5

years. While worker protection continues to be a high priority for the Department,

we have, in the interest of responsible budgeting, carefully reviewed each agency’s

FTE needs with an eye to eliminating unnecessary management layers and ineffi-
232

cient work processes. The budget proposes to redirect these resources to higher priority areas like front-line service delivery.

OSHA, for example, has reviewed its current organizational structure to look for

completed activities or those functions which are better integrated into the frontline work of the agency. Overall, the fiscal year 2002 budget reflects a reduction of

94 FTE—42 management FTE and 52 FTE associated with the previous Administration’s re-invention initiatives. Since OSHA is not reducing safety and health compliance officer staffing, the agency plans on hiring all of the additional enforcement

staff approved by Congress in fiscal year 2001.

The three ESA enforcement programs anticipate a slight reduction in enforcement

staff in fiscal year 2002. Approximately 60 percent of the reduction in the enforcement programs will be taken in overhead staff, which comprises about one-third of

the total enforcement program staffing. A reduction of 93 FTE amounts to approximately a 2 percent reduction in staffing and most, if not all, of that can be absorbed

without negative consequences for enforcement. Within ESA, the Office of Workers’

Compensation Programs anticipates employing the same number of claims examiners in fiscal year 2002 as in fiscal year 2001 for the Federal Employees’ Compensation, Longshore and Harbor Workers’ Compensation, and the Black Lung

Compensation Programs.

With respect to MSHA, during the past five years, the number of coal mine enforcement FTE remained roughly level even as the number of coal mines decreased

by 19 percent. Given this situation, the Agency believes that it can absorb the 47

position reduction in FTE in the coal program without compromising worker safety.

MSHA fully intends to hire the additional 40 FTE approved by Congress for the

metal and nonmetal enforcement program in fiscal year 2001.

CUTS IN WORKFORCE PROGRAMS

Question. You have proposed reductions for programs authorized under the Workforce Investment Act due to the slow expenditure of funds in the first year of implementation. Do you think it is possible that demand for those funds may increase

in the next fiscal year since many States and communities are now planning and

implementing programs based on that funding? If so, is it wise to scale back these

programs at this time?

Answer. In projecting expenditures for the remainder of Program Year (PY) 2000

and PY 2001, and budget needs for PY 2002, DOL assumed that State Workforce

Investment Act (WIA) programs would be fully implemented by June 30, 2001. DOL

also projects State expenditures in succeeding years will be greater than would have

been possible had unexpended balances not increased last year and during the first

six months of this year. There will be no scaling down of programs nationally as

a result of the reduced request for PY 2002. In fact, total spending for WIA State

programs is estimated to be $174 million more in PY 2001 and in PY 2002 than

the PY 2001 budget authority.

Question. How would the proposed cuts affect those States and communities that

are fully spending their funding allocation? Have you heard from any of these

groups since your budget proposal was released?

Answer. DOL staff regularly and routinely speak with States, local communities

and their representatives. There is widespread acknowledgment that spending has

been lower than expected and that the causes are many. In fact, through mid PY

2000, only two States (Delaware and Vermont) had spent more than 50 percent of

the funds available to them in PY 2000. Federal, State and local partners have

joined forces to review the causes and work together to propose policy changes and

assistance that would address the issues.

A few communities might find themselves with fewer resources as allotments are

reduced and they do not have as large an unspent balance as others have. However,

we believe that underspending is widespread and the number of communities that

are fully using funding are few. Most communities will find themselves with sufficient carry-over from earlier years to offset reduced allocations. For those few that

do not have substantial carry-in, we would hope the impact of the proposed reductions can be ameliorated, in part, through reprogrammed monies to the youth formula program in 2001, State reallocation of funds among local areas, State targeting of funds available for Statewide activities, and Federal award of National

Emergency Grants.

With respect to the latter, Dislocated Worker funding is provided to States and

local communities by formula; the Secretary maintains a reserve of 20 percent of

total Dislocated Worker funding, most of which is used for National Emergency

Grants. These grants are available to States and local communities which have fully

spent their formula funds and find themselves needing additional allocations for
233

Dislocated Worker assistance. As a result, we do not expect dislocated workers to

be denied services as a result of the small reduction requested for the program.

WORKER LAYOFFS

Question. In light of the recent sluggish economy, what kinds of worker layoffs

do you expect in the next fiscal year?

Answer. There were 1,445 mass layoff actions in April 2001 as measured by new

filings for unemployment insurance benefits during the month, according to data

from the Bureau of Labor Statistics. Each action involved at least 50 persons from

a single establishment, and the number of workers involved totaled 175,064. In January 2001 through April 2001, the total number of events, at 5,995, and initial

claims, at 719,781, were higher than in January–April 2000 (4,889 and 535,327, respectively).

In April 2001, manufacturing industries accounted for 42 percent of all mass layoff events and 44 percent of all initial claims filed. A year earlier, layoffs in manufacturing accounted for 34 percent of events and 32 percent of initial claims. Manufacturing industries with the highest number of initial claimants were transportation equipment (12,583, mostly in motor vehicles and car bodies), electronic and

other electrical equipment (11,552, largely in semiconductors), and industrial machinery and equipment (11,312, primarily in farm machinery and equipment). Services accounted for 25 percent of events and 28 percent of initial claims filed during

the month. Layoffs in services were highly concentrated in business services (particularly in help supply services, which accounted for 12 percent of the total number

of initial claimants). We also have seen a significant upswing in trade petitions for

last five months.

With the slow economy, we expect this trend to continue through part of the next

fiscal year.

However, the unemployment rate remains low, meaning that many dislocated

workers are able to find new employment with little or no governmental assistance

because they have transferrable job skills. Those who are permanently laid off with

little opportunity to return to their previous occupation or industry often need assistance to find or prepare for new jobs.

Under the Workforce Investment Act, Dislocated Worker services are provided

through the One-Stop system. Dislocated workers who require assistance in finding

new jobs can access a range of services at their local One-Stop Career Centers, ranging from job search assistance to assessment, counseling and retraining.

Question. In your opinion, will a $207 million reduction in the Dislocated Worker

program hurt the chances of those dislocated workers finding new jobs?

Answer. The requested level for the Dislocated Worker program will allow our

State and local partners to meet the employment and training needs of the affected

workers. As a result of efficiencies in administration and service delivery as well as

carry-in funds from prior years’ appropriations, Dislocated Worker programs will

have levels of resources comparable to previous levels. States and local areas whose

needs exceed available resources may request assistance through National Emergency Grants to provide additional Dislocated Worker funding for workers affected

by economic downturns.

ONE-STOP COORDINATION

Question. One of the cornerstones of the Workforce Investment Act was the coordination of resources at the One-Stop, particularly those provided under that Act and

the Wagner-Peyser Act. Are the One-Stops coordinating resources with the State

Employment Service? Are those two offices often located in the same building? If

not, what are your thoughts on how we could improve that coordination?

Answer. The clear intent of WIA is that State employment services authorized by

the Wagner-Peyser Act be delivered solely as part of the locally designed One-Stop

systems. In addition, Wagner-Peyser employment and information services, including labor exchange services, employment statistics and labor market information,

are critical core services that make One-Stop systems responsive to the universal

population. Wagner-Peyser re-employment services are also critical to the linkage

of unemployment insurance claimants to both employment services and more specialized services available within One-Stop centers/systems.

Nationwide, State employment services are entering into memoranda of understanding regarding how services will be delivered in One-Stop systems. WIA allows

for different physical configurations within a One-Stop system. Each local area must

have at least one physical location, a comprehensive One-Stop center, which provides core services and where access to all ‘‘required’’ One-Stop partner services is

available. In addition, the law permits affiliated sites with specialized services as
234

long as the sites are part of the broader One-Stop system. The design of One-Stop

systems varies as it relates to Wagner-Peyser employment services. There are three

primary options for configuring how employment services fit in a One-Stop system:

(1) the employment service office is the location of the comprehensive One-Stop center; (2) employment service staff are fully integrated into the comprehensive OneStop center which is operated by another entity; or (3) an employment service office

is an affiliated office with staff assigned to the comprehensive center.

It is the position of the Department of Labor that Wagner-Peyser services must

be integrated as closely as possible within a One-Stop system. Therefore, we are

working with our State partners to promote integration in a number of ways including, but not limited to:

—developing policy guidance flowing from WIA and the regulations on the role

and ‘‘fit’’ of Wagner-Peyser employment services within One-Stop systems;

—developing and providing technical assistance to State employment service

agencies, local boards, and One-Stop operators to help facilitate the integration

of Wagner-Peyser employment services; and

—identifying best and promising practices and models for integration to share

among the States and local areas.

Question. The justification for flat-funding Job Corps assumes that costs in the

Job Corps program may have risen at the economy-wide rate of inflation in the 2001

budget year, and that substantial funds will be carried over into 2002. However, Job

Corps centers are currently experiencing inflation rates that are significantly higher

than the economy-wide rate of 2.1 percent. If, as a result of higher costs in 2001,

the carryover anticipated for 2002 were not available, what would be the impact on

the quality of Job Corps operations?

Answer. Job Corps’ ability to continue current services without an inflationary increase is due primarily to savings from unplanned delays in new center openings.

These savings, combined with some cost containment efforts, will adequately address our resource needs in PY 2003. Flat funding Job Corps in fiscal year 2002 will

not impact the quality of Job Corps operations.

Question. What would be the impact on the three new centers scheduled to open

in 2002? Would Job Corps have to close centers or reduce the number of students

served?

Answer. As indicated above, Job Corps’ ability to continue current services without an inflationary increase is due primarily to savings from unplanned delays in

new center openings. We will submit a report to Congress detailing the status of

those center openings and the reasons for the current delays. Let us be clear that

these center opening delays are the result of a variety of unplanned events that are

in no way related to the fiscal year 2002 Budget level. Job Corps will not close centers or reduce the number of students served.

ADDITIONAL YOUTH PROGRAM FUNDING

Question. DOL proposes to revise the fiscal year 2001 appropriation for the youth

program by adding $45 million to it from funds reprogrammed from other WIA programs. What is the rationale for adding funds for 2001, then cutting funding in fiscal year 2002?

Answer. For fiscal year 2001, DOL proposes to reprogram the $25 million increase

in 2001 from Youth Opportunity Grants and the initial $20 million from the Safe

Schools/Healthy Students initiative to move funds from targeted programs to core

job training programs, as described in President Bush’s Blueprint for New Beginnings. The Workforce Investment Act was enacted to establish the core youth, adult,

and Dislocated Worker programs, and we believe our emphasis should be on ensuring the success of these programs. The increase in Youth Opportunity Grants in

2001 would have resulted in additional sites that our fiscal year 2002 budget would

not be able to sustain, as would also be the case for the Safe Schools/Healthy Students initiative. We are confident that, with the unexpended funds available from

previous years, our fiscal year 2002 request of $1 billion for Youth Activities will

be sufficient to serve the same number of young people in need of WIA services as

are projected to be served in 2001.

FISCAL YEAR 2002 FUNDING LEVEL

Question. Does the fiscal year 2002 request reflect a one time adjustment in funding as a result of lower than expected levels of expenditures (due to the amount of

time it is taking States to implement WIA)? If so, does the Administration expect

to request funds in fiscal year 2003 to restore the cuts it is proposing in fiscal year

2002?
235

Answer. Yes, our fiscal year 2002 request does take into consideration the fact

that unexpended balances are roughly $600 million greater than the traditional

level. Any fiscal year 2003 request will consider expenditure data between now and

when PY 2003 funding levels are finalized, as well as the Administration’s assessment of the relative size of unspent balances carried into PY 2003.

STATE FLEXIBILITY FOR TRAINING NEEDS

Question. By decreasing funds, which effectively will decrease carry over, is the

Administration reducing the flexibility States have to meet unexpected training

needs that might occur if the economy continues to weaken and more laid off workers need training to obtain jobs?

Answer. As previously indicated, the Department and its State partners will continue to address the needs of laid off workers through awards of formula funds, supplemented, where necessary, by National Emergency Grants.

FUNDS REVERTING TO THE TREASURY

Question. Given the level of spending by States, would you expect any fiscal year

2000 funds to revert to the Treasury if funding were not reduced for the formula

grant programs in fiscal year 2002?

Answer. States have the Program year of Federal award and the two succeeding

Program years to spend funds under WIA. Because of this, we do not expect that

these unspent funds will revert to the Treasury. They will remain in the grant and

carried over for use in future years.

UNSPENT FUNDS LISTED BY STATE AND BY GRANT

Question. Could you please provide to this committee a list of the amount of

unspent grants expected for fiscal year 2000 and fiscal year 2001 for each State by

formula grant program? If you have information on projected unspent funds based

on data more recent than December 2000, would you provide them to this committee?

Answer. The Department does not have projected end of year carryover by State

or program; the attached table shows aggregate estimates by State for expenditures

through December 2000 and is submitted for the record. Our assumptions about expenditures for PY 2001 and PY 2002 are not State-by-State. Estimates may not be

accurate if applied to individual States given differences in State plans and spending rates.
236

EMPLOYMENT AND TRAINING ADMINISTRATION STATE REPORTING OF FORMULA SPENDING WIA YOUTH ADULTS AND DISLOCATED WORKERS PROGRAMS COMBINED

State

Unexpended

carry-in

to PY 2000

PY 2000 allotments

Total available

7/1/00–12/31/00

(& PY 2000 Youth:

4/1/00–6/30/00)

Expenditures 7/1/00–12/31/00

(& PY 2000 Youth:

4/1/00¥6/30/00)

Unexpended balance as of 1/1/01

PY 2000 portion

excluding advance

funding

FY 2001 advance

funding

Total allotments

(includes advance

funding available

beginning

FY 2001)

Total % of al- lotments % of avail- able Total % of al- lotments % of avail- able

Alabama .................................................. $7,204,025 $21,569,576 $18,435,358 $40,004,934 $47,208,959 $12,944,260 32.4 27.4 $34,264,699 85.7 72.6Alaska ...................................................... 453,000 6,220,665 6,804,719 13,025,384 13,478,384 2,734,243 21.0 20.3 10,744,141 82.5 79.7Arizona ..................................................... 6,170,133 22,265,696 18,050,796 40,316,492 46,486,625 10,087,539 25.0 21.7 36,399,086 90.3 78.3Arkansas .................................................. 8,941,265 17,060,263 15,813,292 32,873,555 41,814,820 7,910,502 24.1 18.9 33,904,318 103.1 81.1California ................................................. 50,370,517 310,532,858 319,358,288 629,891,146 680,261,663 136,440,050 21.7 20.1 543,821,613 86.3 79.9Colorado .................................................. 3,804,877 11,133,399 10,794,033 21,927,432 25,732,309 5,900,041 26.9 22.9 19,832,268 90.4 77.1Connecticut ............................................. 3,620,292 12,391,413 11,276,123 23,667,536 27,287,828 7,063,815 29.8 25.9 20,224,013 85.5 74.1Delaware .................................................. 1,694,396 3,603,138 2,887,440 6,490,578 8,184,974 4,167,507 64.2 50.9 4,017,467 61.9 49.1District of Columbia ................................ 1,384,000 9,011,879 10,103,668 19,115,547 20,499,547 6,051,585 31.7 29.5 14,447,962 75.6 70.5Florida 1 ................................................... 65,279,463 62,533,829 56,846,081 119,379,910 184,659,373 86,121,969 72.1 46.6 98,537,404 82.5 53.4

Georgia .................................................... 11,966,905 32,680,141 29,305,954 61,986,095 73,953,000 13,874,807 22.4 18.8 60,078,193 96.9 81.2Hawaii ..................................................... 5,462,399 11,851,140 13,166,154 25,017,294 30,479,693 5,058,091 20.2 16.6 25,421,602 101.6 83.4Idaho ....................................................... 3,697,810 7,068,503 6,933,051 14,001,554 17,699,364 4,665,156 33.3 26.4 13,034,208 93.1 73.6Illinois ...................................................... 6,425,117 62,507,353 54,649,207 117,156,560 123,581,677 28,274,929 24.1 22.9 95,306,748 81.3 77.1Indiana .................................................... 7,134,777 17,145,854 14,928,500 32,074,354 39,209,131 16,609,855 51.8 42.4 22,599,276 70.5 57.6Iowa ......................................................... 2,717,190 5,718,570 5,734,756 11,453,326 14,170,516 3,501,904 30.6 24.7 10,668,612 93.1 75.3Kansas ..................................................... 2,346,659 6,217,232 6,430,585 12,647,817 14,994,476 4,065,239 32.1 27.1 10,929,237 86.4 72.9Kentucky .................................................. 34,811,212 23,190,724 19,259,988 42,450,712 77,261,924 18,029,020 42.5 23.3 59,232,904 139.5 76.7Louisiana ................................................. 12,202,135 34,855,558 31,745,279 66,600,837 78,802,972 13,427,930 20.2 17.0 65,375,042 98.2 83.0Maine ....................................................... 100,000 5,918,650 5,323,098 11,241,748 11,341,748 3,940,588 35.1 34.7 7,401,160 65.8 65.3Maryland .................................................. 11,977,850 22,762,126 21,383,922 44,146,048 56,123,898 14,054,255 31.8 25.0 42,069,643 95.3 75.0Massachusetts ........................................ 3,070,000 20,596,131 18,433,727 39,029,858 42,099,858 15,477,068 39.7 36.8 26,622,790 68.2 63.2Michigan .................................................. 10,625,065 43,150,489 35,227,909 78,378,398 89,003,463 25,246,367 32.2 28.4 63,757,096 81.3 71.6Minnesota ................................................ 4,862,114 12,661,947 11,192,310 23,854,257 28,716,371 11,136,597 46.7 38.8 17,579,774 73.7 61.2Mississippi .............................................. 7,545,109 19,849,458 17,445,585 37,295,043 44,840,152 8,407,897 22.5 18.8 36,432,255 97.7 81.2Missouri ................................................... 9,220,801 22,537,168 20,531,057 43,068,225 52,289,026 11,812,901 27.4 22.6 40,476,125 94.0 77.4Montana .................................................. 874,719 7,330,069 7,429,328 14,759,397 15,634,116 4,751,724 32.2 30.4 10,882,392 73.7 69.6Nebraska ................................................. 1,562,920 3,843,427 3,370,955 7,214,382 8,777,302 1,593,856 22.1 18.2 7,183,446 99.6 81.8Nevada .................................................... 1,023,781 6,236,289 6,052,345 12,288,634 13,312,415 3,126,560 25.4 23.5 10,185,855 82.9 76.5New Hampshire ....................................... 352,571 3,796,677 3,276,886 7,073,563 7,426,134 1,695,816 24.0 22.8 5,730,318 81.0 77.2New Jersey ............................................... 18,918,820 39,764,126 38,034,164 77,798,290 96,717,110 27,749,286 35.7 28.7 68,967,824 88.6 71.3New Mexico .............................................. 888,554 16,388,725 21,437,086 37,825,811 38,714,365 9,060,603 24.0 23.4 29,653,762 78.4 76.6
237

New York ................................................. 163,730,964 148,728,129 156,225,476 304,953,605 468,684,569 42,802,149 14.0 9.1 425,882,420 139.7 90.9North Carolina ......................................... 13,648,284 23,561,472 21,935,374 45,496,846 59,145,130 15,529,729 34.1 26.3 43,615,401 95.9 73.7North Dakota ........................................... 735,455 3,522,617 2,725,413 6,248,030 6,983,485 2,234,580 35.8 32.0 4,748,905 76.0 68.0Ohio ......................................................... 18,566,094 61,982,728 50,847,933 112,830,661 131,396,755 15,795,680 14.0 12.0 115,601,075 102.5 88.0Oklahoma ................................................ 3,965,403 15,582,047 13,092,549 28,674,596 32,639,999 5,553,484 19.4 17.0 27,086,515 94.5 83.0Oregon ..................................................... 7,288,406 28,275,038 30,992,014 59,267,052 66,555,458 14,705,981 24.8 22.1 51,849,477 87.5 77.9Pennsylvania 1 ......................................... 43,473,437 55,552,160 51,169,069 106,721,229 150,194,666 39,674,951 37.2 26.4 110,519,715 103.6 73.6

Puerto Rico .............................................. 82,022,985 103,556,318 111,940,940 215,497,258 297,520,243 51,195,386 23.8 17.2 246,324,857 114.3 82.8Rhode Island ........................................... 732,708 4,082,645 3,811,684 7,894,329 8,627,037 2,536,074 32.1 29.4 6,090,963 77.2 70.6South Carolina ........................................ 5,651,400 18,242,679 15,239,431 33,482,110 39,133,510 8,681,128 25.9 22.2 30,452,382 91.0 77.8South Dakota ........................................... 1,524,676 3,541,195 2,762,797 6,303,992 7,828,668 2,434,662 38.6 31.1 5,394,006 85.6 68.9Tennessee ................................................ 11,326,551 27,717,111 23,061,871 50,778,982 62,105,533 12,670,648 25.0 20.4 49,434,885 97.4 79.6Texas ....................................................... 67,300,071 134,094,193 111,733,955 245,828,148 313,128,219 119,541,113 48.6 38.2 193,587,106 78.7 61.8Utah ......................................................... 3,219,027 5,433,280 4,965,519 10,398,799 13,617,826 3,497,324 33.6 25.7 10,120,502 97.3 74.3Vermont 1 ................................................. 590,542 3,455,742 2,590,847 6,046,589 6,637,131 4,657,829 77.0 70.2 1,979,302 32.7 29.8

Virginia .................................................... 7,300,000 20,744,067 17,994,165 38,738,232 46,038,232 8,246,066 21.3 17.9 37,792,166 97.6 82.1

Washington .............................................. 12,731,724 35,864,208 34,182,597 70,046,805 82,778,529 20,479,984 29.2 24.7 62,298,545 88.9 75.3West Virginia ........................................... 10,000,000 20,886,759 23,332,050 44,218,809 54,218,809 13,094,672 29.6 24.2 41,124,137 93.0 75.8Wisconsin ................................................ 2,688,907 15,799,916 14,706,901 30,506,817 33,195,724 14,471,966 47.4 43.6 18,723,758 61.4 56.4Wyoming .................................................. 2,688,907 3,688,545 3,059,298 6,747,843 9,436,750 2,819,580 41.8 29.9 6,617,170 98.1 70.1

Total Formula ............................. 765,894,017 1,636,703,922 1,558,031,527 3,194,735,449 3,960,629,466 925,604,946 29.0 23.4 3,035,024,520 95.0 76.6

1 Revised/corrected expenditures for Florida and Vermont; corrected carry-in for Pennsylvania.
238

QUESTIONS SUBMITTED BY SENATOR TOM HARKIN

ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM (EEOICPA)

Question. In a televised interview (McLaughlin’s ‘‘One on One’’ from 3/23/01) I understand you said the DOL has ‘‘no capability, no infrastructure’’ to carry out the

nuclear workers compensation program. I am surprised at this statement given the

history of Office of Workers’ Compensation Programs in administering the Federal

Employees’ Compensation Act, as well as compensation for coal mine workers and

longshore and harbor workers. What capability and infrastructure do you need to

build?

Answer. My comments centered on the statutory deadline for the Department to

implement this large new program. This reality poses significant challenges, thus

warranting my public concern. While the Energy Employees Occupational Illness

Compensation Program bears some resemblance to ESA’s other compensation programs, its size, covered population, and unique requirements have necessitated the

establishment of a new claims processing and adjudication infrastructure. The Department has created a unit within ESA, with its own dedicated staff, to handle the

large number of expected claims. This unit will be responsible for accepting and adjudicating claims under the program, which will include such tasks as determining

the probability that an individual’s cancer was as likely as not due to radiation exposures and adjudicating all disputes arising from the claims process.

Question. Given your concerns, what are your plans to bring in expertise to start

the program?

Answer. Since EEOICPA’s enactment, the Department has been working with the

Departments of Energy, Health and Human Services, and Justice to implement this

program in a fair and equitable manner. We have utilized private-sector contractors

to a great extent. In our efforts to build the organizational structure to administer

this program, we are reaching out in a very broad way to recruit the staff necessary

to operate this program. This will include staff to adjudicate claims and those with

technical expertise in areas such as radiation measurements and exposures. Simply

put, we are utilizing every available resource to assure the timely and effective implementation of this program.

Question. Would you consider setting up an outside advisory committee to help

address some of the issues? Could you use the Department of Energy’s Office of Environment, Safety and Health Public Advisory Committee, which already has dealt

with this program, for this purpose?

Answer. As you know, the EEOICPA established an Advisory Board on Radiation

and Worker Health. In addition, as you note, the Department of Energy’s Office of

Workers’ Advocacy has also established an advisory committee. We have been engaged with, and will continue to participate in, the DOE Advisory Committee and

will participate in the Advisory Board on Radiation and Worker Health when it is

established. We will use these forums as well as continuing to meet with stakeholders in a variety of other settings to get input on administering this program.

These avenues for obtaining input have seemed most beneficial at this point, especially given the July 31 implementation deadline the Department must meet. In

light of this deadline, we have had to focus our efforts on ensuring that eligible

claimants receive benefits as soon as possible after this date. At a later date, we

will consider whether there is a need to establish another advisory body.

Question. Last year the DOL proposed some amendments to the EEOICPA, including adding an option of providing a sick worker with lost wages. Do you support

these proposed changes?

Answer. In January of this year, the previous Administration forwarded a set of

proposed amendments to the EEOICPA to Congress. The extremely short deadlines

for publishing regulations and implementing this program have required DOL to

focus exclusively since then on efforts to promulgate regulations and create procedures and systems necessary to undertake our responsibilities under EEOICPA and

Executive Order 13179. Thus, consideration of possible legislation must await our

completion of the initial implementation of the program. We will consult with the

Office of Management and Budget and other agencies with responsibility under

EEOICPA to assess the need for a legislative proposal.

Question. I understand you recently recommended to OMB that ‘‘the Administration support technical legislation that will soon be introduced to remedy some of the

remaining deficiencies in the EEOICPA.’’ What are these deficiencies, what amendments to EEOICPA will you recommend, and when you do expect the legislative

proposal to be introduced?

Answer. EEOICPA contains virtually no provisions concerning administration of

the program or review of decisions made on claims for benefits. In drafting
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EEOICPA, Congress recognized that the statute did not create a comprehensive

compensation system when it directed submission of further legislation to implement the program. In addition to the almost total lack of administrative and review

provisions, it also contains ambiguous or unclear provisions and certain provisions

that appear to have adverse consequences that may not have been intended. As

noted in the previous response, however, extremely short deadlines for implementing EEOICPA have required DOL to focus on that task. We do intend, however, to further review this legislation and consult with the Office of Management

and Budget and other agencies with responsibility under EEOICPA to determine

the appropriate nature and timing of a legislative proposal.

Question. I understand you said that DOL could not meet the statutory deadline

to begin accepting applications. When do you expect to be ready to accept applications, and when should workers who qualify expect to begin receiving compensation?

Answer. As a result of the extraordinary effort and dedication of DOL’s career

staff, interim final regulations were published on May 25, 2001 and will take effect

60 days thereafter. This will allow us to begin officially accepting applications on

July 31, 2001, the date that the legislation provides for the statute to take effect.

For straightforward cases, we expect to begin paying EEOICPA benefits by early

fall.

However, it must be recognized that there will be a surge of claims filed in the

first days of this program for illnesses and deaths occurring over more than a half

century. While we are making every effort to address this up-front claims workload,

it will be very difficult to process this volume of cases immediately. Based on our

knowledge of this population, we expect that many claims will require significant

work on the part of DOL, DOE, and HHS to piece together decades-old work history

and exposure data. Claimants whose cases will require complex adjudication—especially of those for whom HHS must complete an individual radiation dose reconstruction—will need to realize that it may take many months for all aspects of their

case to be fully reviewed.

Question. How do you expect to handle workers with covered radiogenic cancers

for whom dosimetry records do not exist? How will they be considered for inclusion

in a Special Exposure Cohort?

Answer. The Department of Health and Human Services’ National Institute on

Occupational Safety and Health (NIOSH) has been assigned responsibility for developing methodologies for ‘‘reconstructing’’ reasonable estimates of radiation doses received by individuals, and for carrying out individual dose reconstructions in each

case where the claimant is determined by DOL to be a covered employee, but is not

a member of a Special Exposure Cohort. In the absence of complete dosimetry data,

these estimates will be used by DOL to determine the probability that an individual’s cancer was as likely as not due to occupational radiation exposure. In addition,

HHS is developing a process for designating additional members to the Special Exposure Cohort, with the advice of the Advisory Board on Radiation and Worker

Health. These issues will be addressed in the regulations being developed for

EEOICPA by HHS.

Question. How do you expect to coordinate with the Department of Energy for

workers whose illnesses may have been caused by radiation or by hazardous substances?

Answer. The EEOICPA does not preclude filing for benefits under both EEOICPA

and State workers’ compensation. EEOICPA provides for assisting workers in obtaining State workers’ compensation benefits through the DOE Office of Worker Advocacy. We anticipate that individuals who were exposed to both radiation and other

toxic substances will file claims under both programs. We are coordinating with

DOE in many areas, but particularly through the establishment of joint DOE/DOL

resource centers near nine major DOE nuclear sites, where claimants will be able

to get direct assistance in filing under either, or both, programs.

Question. Does the budget include sufficient funds for timely implementation of

the program?

Answer. The funding for EEOICPA is sufficient and will not affect our ability to

meet the established time frames. The difficulties in meeting the time frames are

related to the tremendous amount of work to be done, and the lack of lead time

available to acquire and gear up the staff and other resources necessary to be at

peak capacity at the inception of the program. Establishing the organization structure, acquiring office space, purchasing equipment, hiring and training staff, developing essential data, communications, and financial systems, and developing detailed procedures for administering such a complex program these are all major undertakings. I assure you that we are doing everything possible to stay on schedule.
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STAFFING SHORTAGES

Question. What is the Labor Department’s strategy in addressing the existing

shortage of female-dominated jobs, such as nursing, day care and teaching?

Answer. Within a few decades, some demographic experts believe the American

workforce simply will not be large enough to meet the demands of a continually

growing economy. Nurses, day care providers, and teachers are a large part of this

‘‘incredibly shrinking workforce.’’

These professions are of tremendous value to our communities. Every day they

care for our neighbors and educate our children. The President has begun the process of elevating the appreciation for the individuals in these careers. We must show

consideration for the value of these professions not only in dollars and benefits, but

also in respect.

The Department will continue to evaluate the Nation’s current skills gap and

worker shortage and identify methods, including those that cross Departmental

lines, that allow us to address this problem—both short- and long-term. We are, in

fact, already working to address some of these shortages. For example, under the

Workforce Investment Act of 1998, our locally-driven workforce investment boards

may certify occupations that are in demand in their area in which an eligible individual may select training. For example, Certified Nursing Assistants (CNAs) represent an occupation that is very much in demand in most local areas. Therefore,

an individual who goes to a One-Stop Career Center and becomes eligible for training will likely see CNA training offered as a response to one of the occupational

choices. Many One-Stop Career Centers also offer access to training in advanced

skills that require certification, such as medical laboratory technicians, operating

room technicians, and inhalation therapists.

BUREAU OF INTERNATIONAL LABOR AFFAIRS (ILAB)

Question. Madame Secretary, in this era of globalization, American workers are

now pitted against workers throughout the global economy in tough, hard-nosed

competition as never before. Their jobs and living standards are at unprecedented

risk. Why are you proposing such drastic cuts in the Bureau of International Labor

Affairs? This is the office of the Federal Government that has the greatest expertise

in international worker rights issues (i.e. abusive child labor), and labor standards

at a time when President Bush is requesting trade authority and even says there

are legitimate trade-related worker rights issues that must be addressed in the impending fast-track debate.

Answer. The President’s fiscal year 2002 request for ILAB preserves the Bureau’s

core responsibilities and recognizes the importance of eradicating all forms of abusive child labor and promoting international labor standards throughout the world.

Funding for these programs has multiplied dramatically over the past years. The

proposed spending levels help us to effectively balance our priorities while maintaining management controls and sensible spending policies that are crucial to our domestic well-being.

The budget request includes funding for ILAB’s core mission, and provides

$30,000,000 to support projects that remove children from exploitative work and

provide them with an education and their families with viable economic alternatives; $10,000,000 to support work on an HIV/AIDS through workplace-based prevention and education programs and technical assistance to improve the working

environment of employees living with AIDS; and approximately $19,000,000 to continue multilateral and bilateral projects to help developing countries establish labor

protections so that workers everywhere can enjoy fundamental rights and principles

at work and help strengthen the ability of developing countries’ to implement social

safety net policies and programs to foster economic growth.

Question. Madame Secretary, I am troubled by reports I’ve heard that no appointment for the position of Deputy Undersecretary of Labor for International Affairs

is expected before this coming fall. Is this true and, if so, how can you leave this

important position vacant for so long and still claim to be giving priority treatment

to child labor, enforcing worker rights law on the books, advancing trade-linked

worker rights issues and promoting greater respect for internationally-recognized

worker rights?

Answer. We plan to fill this position as soon as we have identified a person with

the qualifications and expertise we seek. In the meantime, the Bureau is in the capable hands of experienced career professionals.
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PENSION AND WELFARE BENEFITS ADMINISTRATION

Question. Last year, I worked with the Pension and Welfare Benefits Administration to expand the assistance program through which they help retirees understand

their rights under the Employee Retirement Income Security Act of 1974 (ERISA).

I am disappointed to see that your budget for this activity under the Policy, Regulation and Public Services Account is cut by $1 million.

The retirement of the baby boom generation doesn’t just affect Social Security, it

also creates a large influx of retirees that need to understand their pension rights.

In addition, the volatility of the stock market rightly has all concerned, acutely affects retirees with defined contribution and 401K plans. Given the increasing demand for retiree assistance and the increasing importance of that assistance in light

of the changing economy, how do you justify cutting the one Federal service that

counsels retirees about their pension rights?

Answer. We have not reduced the request levels for benefit advisors that counsel

retirees and other participants about their pension rights, nor have we reduced the

levels of advisors that provide assistance to employers in plan operations. The Pension and Welfare Benefits Administration (PWBA) is committed to providing participant assistance. There are currently 105 FTE dedicated to participant assistance—

16 in the national office and 89 in the field offices. In fiscal year 2000, these Benefit

Advisors assisted over 150,000 participants. Also in fiscal year 2000, PWBA adopted—for the first time—a Strategic Plan for Outreach, Education and Assistance. The

plan includes specific performance measurements. PWBA also is beginning a pilot

project to implement an 800 number. Assisting participants in health and retirement plans to make sure they understand their rights and receive the benefits to

which they are entitled is a priority for me and the Department. PWBA will continue to fulfill this mission to the fullest extent possible.

DISPARITY IN WIA BUDGET REQUEST REDUCTIONS

Question. This budget requests a $473.9 million cut in employment and training

programs, claiming that unexpended carryover funds from last year will allow

States to maintain service levels while taking that large of a cut. Madame Secretary, although large amounts of carryover may exist in some States, the amount

varies per State. Dislocated Worker funds go to States on a formula basis. Therefore, every State will take the same percentage cut in funding, regardless of the

amount of carryover they have.

First, how do you deal with the disparity between States with small amounts of

carryover and large cuts in fiscal year 2002 funds? Doesn’t this method of cuts actually punish States who have implemented the new Workforce Investment Act quickly and efficiently?

Answer. Information received to date indicates very few States are without significant carry-over available to maintain 2001 projected service levels through 2002.

The Department is prepared to assist these States however possible. For example,

the Department maintains a sizable reserve for National Emergency Grants where

Dislocated Worker formula funds are insufficient to meet worker needs. As always,

we will move quickly to make these awards where the need is demonstrated.

Question. Second, these cuts will not go into effect until July of 2002 and your

analysis of unexpended carryover is as of January 1, 2001. Do you not expect WIA

to be fully implemented and working as planned in the next 18 months?

Answer. The Department expects WIA to be fully implemented by June 30, 2001,

and program spending to have resumed to levels commensurate with amounts appropriated. As you indicate, the spending projections are based on unspent balances

as available December 31, 2000 and what we believe to be reasonable estimates of

increased spending through the remainder of this program year. Based on these estimates and our expectation that the WIA implementation issues that limited program spending will be resolved and the program fully implemented, we have projected an amount available on June 30, 2001 that, when added to available PY 2001

funds and the amounts requested for PY 2002, will allow spending, nationally, at

levels greater that what was provided by the Congress for 2001.

PERSONAL PROTECTIVE EQUIPMENT

Question. Another important standard has been developed that clarifies who pays

for personal protective equipment that is required by the employer. Some employers

actually charge workers for ear plugs, rubber boots and protective gloves, even

though this is the primary means of protection that the workers have, for example,

from the hazards of noise, slippery floors, and sharp knives. The OSH Act requires

the employer to pay for engineering controls, such as ventilation and machine
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guards. When employers require workers to pay for PPE, they are passing along the

economic burden of controls to workers, often those in the lowest paying jobs, such

as poultry processing. It is our hope that you would examine this issue, look at the

regulatory record, and urge final approval. This is not a major regulation, and it

is not a major issue to most employers. However, it is a major cost to many lowwage workers who have to spend an additional portion of their hard won paychecks

in order to do their jobs.

Can you tell me the status of the proposed regulation? Can you give me a timetable on when it might be completed?

Answer. As discussed below, the new Administration has not completed its review

of OSHA’s regulatory agenda. Until that review is completed, I am unable to give

you a timetable for this proposal.

LUMP SUM PENSION DISTRIBUTIONS

Question. Please provide me with a detailed explanation of where DOL and Treasury are regarding taking actions on the lump sum issue discussed [in my request]

and what the Pension and Welfare Benefits Administration is doing to improve its

ability to ferret out significant broad failures of plans to properly inform plan participants of their rights or to properly provide benefits.

Answer. I am familiar with the concerns raised in your January 2000 letter to

Secretary of Labor Herman and Secretary of the Treasury Summers concerning the

information disclosed to pension plan participants about their benefit distribution

options. I believe that pension plan participants need and deserve sufficient information about their plan and benefits, including distribution options, to make informed decisions about their retirement. We are reviewing this issue and will respond more comprehensively when we have reached any conclusions.

FAIR LABOR STANDARDS ACT (FLSA)

Question. As you know, the Fair Labor Standards Act provides the most basic

labor standards for working Americans, including child labor, minimum wage and

overtime protections. In recent years, enforcement of the Act has suffered from lack

of funding for investigators that are far too few in number to adequately enforce

the law in the many thousands of workplaces across the country.

Will you ensure that wage-hour enforcement gets the priority, and the funding

that it needs to protect the workers’ wages?

Answer. I am committed to enforcement of worker protection laws. One of my

goals is to ensure an honest day’s pay for an honest day’s work. While it is true

that the number of investigators in the Wage and Hour Division declined throughout the early 1990s, the number of investigators steadily increased beginning in

1996 and is now at its highest level. There is sufficient funding in the fiscal year

2002 budget to maintain the current level of investigators. In addition to enforcement, compliance education is another strategy for protecting workers’ wages. I am

encouraging the Department’s enforcement agencies to undertake a renewed emphasis on compliance assistance.

Question. While there have been slight increases, there are still significantly fewer

investigators than 15 years ago for more workplaces. Will you press for and will you

support funding for more investigators?

Answer. At the end of fiscal year 2000, the number of investigators in the Wage

and Hour Division was equal to the number of investigators in fiscal year 1985.

Wage and Hour currently has 21 percent more investigators than at the end of fiscal

year 1996. While I appreciate the fact that there are now more employers covered

by the laws administered by the Wage and Hour Division than there were 15 years

ago, I am not at this point seeking additional funding for investigators. Rather, I

believe that providing compliance assistance to this increased number of employers

is an important factor in the equation to improve compliance with worker protection

laws.

Question. In September 1999, the General Accounting Office issued a report to the

House of Representatives which found that many of the nation’s low-income workers

were being illegally misclassified as exempt from overtime, often by conferring on

those workers fancy titles that disguise the true nature of their work. For example,

a cook paid a salary of $200 per week may be called an Executive Chef and

misclassified as exempt from overtime.

Are you willing to use the resources of your office to stop this kind of illegal exploitation of low-income workers by (a) increasing enforcement, and (b) providing

education to employers about their responsibilities and providing information to

workers about their rights?
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Answer. The primary goal of the Wage and Hour Division is to increase compliance with labor standards laws and regulations, including those affecting young

workers, and workers in low-wage industries. To increase compliance, Wage and

Hour has adopted a multi-prong strategy of compliance education, enforcement and

partnerships.

Compliance education includes such activities as seminars for employers and employer associations; town hall meetings for workers; and distribution of a variety of

compliance materials, including fact sheets, compliance manuals and wallet-sized

cards. In addition, the Department has developed Elaws Advisors, an interactive

internet-based tool which provides easy-to-understand expert advice on the basic requirements of the Fair Labor Standards Act and the Family and Medical Leave Act.

A separate module covers the Federal child labor requirements. In September 2000,

Wage and Hour began operation of the first phase of the Technology for Excellent

Customer Service program, a national toll-free number to answer questions and

refer callers to the appropriate office for service.

The enforcement component of the strategy includes the use of traditional enforcement tools like investigations; the assessment of civil money penalties; targeted

strike forces, particularly in low-wage industries; and the use of the ‘‘hot goods’’ provision of the FLSA that prohibits the shipment in interstate commerce of goods produced in violation of the Act.

Establishing various partnerships leverages Wage and Hour’s limited resources

and broadens the impact of the other strategies. Wage and Hour enters into partnerships with employers and employer associations to urge proactive steps to help

ensure current and future compliance, as well as with non-profit and communitybased organizations, and States and other Federal agencies to help reach low-wage

employees and make them aware of their rights.

Question. The GAO Report also found that the primary cause of this type of exploitation was that regulatory minimum salary levels for workers to qualify for overtime-exempt status had not kept pace with inflation since they were last adjusted

in 1975, a quarter of a century ago. For example, in 1975 about 30 percent of the

full-time work force would have been automatically entitled to overtime because

their pay did not exceed these minimum salary levels. However, in 1998, because

of the failure of these levels to keep pace with inflation, only 1 percent of this workforce would be automatically entitled to overtime.

Will you support raising the minimum salary levels to account for the effects of

inflation over the last 25 years?

Answer. In May 2000 the House Subcommittee on Workforce Protections of the

Committee on Education and the Workforce, U.S. House of Representatives, held a

hearing in connection with the GAO’s report and received testimony from business

and labor representatives, as well as from the Department of Labor. Witnesses at

the hearing confirmed GAO’s assessment that the ability to move forward with constructive and appropriate changes to the regulations has proven extremely difficult

because of the strongly-held views of the many affected and interested parties and

the significant impact of possible changes. After that hearing, the Department of

Labor began a modest research effort to identify areas in which we would need additional information to analyze the evolution of the overtime-exempt categories of

workers and how they are classified by their employers. The regulations are currently scheduled on the Department of Labor’s regulatory agenda for upcoming review and possible future revisions. However, there is much more to be learned before we will be fully positioned to offer specific regulatory changes.

OSHA ERGONOMISTS

Question. How many ergonomists does OSHA currently employ? Do you have

plans to hire more?

Answer. There is no Federal job classification titled ‘‘ergonomist.’’ However, OSHA

currently has two certified professional ergonomists; approximately six field compliance officers with advanced degrees in disciplines in industrial engineering, with

concentration in ergonomics; between 20 and 30 field people who have extensive

training in ergonomic intervention in specific industries, such as meat packing and

textiles; and three individuals with extensive ergonomics expertise with the Salt

Lake City Health Response Team.

UNDERREPORTING OF INJURIES

Question. OSHA’s research and the information collected at the recent hearings

show that there is extensive underreporting of MSDs. In fact, based on the record

compiled in the recent rulemaking process, OSHA concluded ‘‘that for every reported

MSD, another MSD goes unreported.’’
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What do you plan to do to correct this problem of underreporting? Are you dedicating any additional resources to addressing this problem?

Answer. The Department is developing a comprehensive approach to addressing

ergonomics. One of the many issues we will investigate is the underreporting of

MSDs that OSHA asserted during the recent rulemaking. While it is too early to

say for certain, I believe that lack of awareness of MSDs and an inability to universally define such injuries are plausible reasons for underreporting. Furthermore, I

believe raising awareness of MSDs on the part of both employers and employees will

help to prevent MSDs before they occur. I intend to use what I find from looking

at the reasons for underreporting to create systems that will disseminate information to employers and employees on the best ways of preventing MSDs.

During the month of July, the Department will hold three forums to address,

among other issues, the definition of what constitutes an ergonomics injury. The Department plans to publish a report, based on the information collected from the forums, that will address the issue of underreporting.

ERGO II

Question. You have repeatedly asserted that ergonomics is a priority for this Administration’s Department of Labor. Yet, the Administration has indicated that it

will nominate Mr. Eugene Scalia for Solicitor General. As Solicitor General, Mr.

Scalia would oversee all standard setting or enforcement of ergonomics, yet Mr.

Scalia has repeatedly opposed any ergonomics standard, going so far as to call

ergonomics, ‘‘a questionable science.’’ In fact, Mr. Scalia has written extensively in

opposition to any ergonomics standard setting or enforcement by OSHA.

Have you discussed with him the importance of ergonomics in this Administration

and is it your sense that he will actively pursue a new ergonomics rule?

Answer. As Secretary, I have pledged to take a comprehensive approach toward

ergonomics. I have met with numerous stakeholders and experts to discuss the issue

during my short tenure, including representatives of workers, industry, and safety

and health professional, and I have outlined certain key principles that will guide

the Department’s approach toward ergonomics under my leadership. Eugene Scalia,

the President’s nominee for Solicitor of Labor, has a broad range of experience in

labor and employment law and a distinguished record of service in past administrations. I have emphasized to him the importance of the issue of ergonomics to this

Administration and to the Congress. I am confident that, as Solicitor, he will faithfully discharge his responsibility to legally represent whatever ergonomics policy we

establish.

OSHA ENFORCEMENT BUDGET

Question. There is a $3 million increase for OSHA’s enforcement budget, there is

also a cut of 64 FTEs. The budget indicates that OSHA will conduct 36,400 Federal

enforcement inspections in fiscal year 2002, the same as fiscal year 2001. How will

the agency conduct the same number of inspections with fewer enforcement officers?

Answer. None of the FTE being cut are compliance safety and health officers. As

a result, the agency will be able to conduct the same level of inspections as in fiscal

year 2001. The staffing cuts reflect reductions in management and FTE associated

with reinvention, not front line inspector positions.

OSHA STANDARDS

Question. You have laid out a very ambitious health and safety standard setting

program and I commend you for that. OSHA expects to issue 15 proposed standards

in fiscal year 2002, versus only one in fiscal year 2001, and 6 final standards in

fiscal year 2002, versus 5 in fiscal year 2001. Can you give me the status of the

following standards and whether you will publish them in final form in fiscal year

2002?

—Tuberculosis

—Employer payment for personal protective equipment

—Glycol ethers

—Signs, signals and barricades

—Exit routes update

—Personal fall protection systems

Answer. The new Administration is still reviewing the regulatory agendas of the

Federal agencies, including OSHA. Until that review is complete, it would be premature to specify OSHA’s regulatory priorities or timetables for specific projects.
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WIA BUDGET REQUEST REDUCTIONS

Question. We are currently in the midst of the first year of implementation of the

Workforce Investment Act, and people throughout the country are working hard to

change our systems to accommodate the new Act. Many areas have had slow rates

of expenditures over the first 6 months of the program, but as they get their systems up and running, the expenditure rates are increasing every day.

However, the effect of these proposed cuts will not be felt until July 2002, when

all systems should be running smoothly.

I am concerned about making cuts which are based on projections made only 6

months into the new Act. Can you discuss the implementation of the Act and reassure me that these cuts will not result in cuts in service?

Answer. The transition from the Job Training Partnership Act structure to the

new Workforce Investment Act has resulted in much slower spending than originally projected. While many jurisdictions jump started partnership- and systembuilding activities during PY 1999, July 1, 2000 marked States’ and local communities’ transition to WIA and its many reforms. Because of the nature of these reforms, full implementation of WIA by States and local communities is taking longer

than originally expected, and the current lower than expected expenditures reflect

this one-time phenomenon. While fewer participants will be served in PY 2000 than

were served in PY 1999, States and local communities will be able to serve many

more participants in PY 2001 and PY 2002 because of the availability of the carry

over funds.

Major reasons for slower than anticipated activity include:

Implementing Fundamental WIA Changes Takes Time.—WIA requires fundamental system-wide changes in service delivery, the make-up of eligible service providers, and new customer service requirements. In addition, there also were major

changes to State and local governance structures.

Workforce Investment System Access to Other Funds.—State and Local Workforce

Investment Boards are encouraged to think strategically about how to use WIA and

other funds most effectively in order to address labor market needs of the broad

population served by WIA. They have used other funds available such as JTPA

carry in dollars or Pell grants for low-income, college-ready adults before drawing

down PY 2000 WIA funds.

More Emphasis on Universal Labor Exchange.—States and local communities

have spent much energy and time on making the One-Stop Center networks under

WIA work so that customers can access information about core job training, education, and employment services at a single location.

QUESTIONS SUBMITTED BY SENATOR TED STEVENS

Question. I am concerned that the Labor Department budget proposes a workers’

compensation surcharge that would cost the Defense Department an additional

$36.7 million—and all Federal agencies a total of $80.3 million. What is the rationale for including this legislative proposal in an appropriations bill? If Congress denied this request, where would you suggest making cuts elsewhere in your budget

to restore the funds needed to administer workers’ compensation programs?

Answer. Ensuring the safety of American workers is a priority of the Department

of Labor. In the Federal arena, we see an urgent need to focus the actions of the

employing agencies on increasing worker safety, in part, by highlighting for them

the full cost of worker injuries, including the cost of administering the Federal Employees’ Compensation Act (FECA) program. As you know, Federal agencies are

billed each year for cash and medical benefits that have been paid to their employees under FECA, while DOL bears the cost of administering the program. The fiscal

year 2002 Budget proposes to integrate benefit and administrative costs by allowing

DOL to add an administrative surcharge to the annual bill DOL now sends to Federal agencies for FECA benefits. Because the surcharge is based on an agency’s

FECA benefits, we believe this proposal would provide an additional incentive for

agencies to control FECA costs by preventing injuries and cooperating in return-towork efforts.

We believe that an appropriations bill is the most efficient vehicle for establishing

an appropriate funding mechanism that both ensures adequate funding for the administration of the FECA and enhances the safety of Federal workers by demonstrating the real cost of injuries. Our budget proposal provides for a surcharge

that accomplishes this purpose and establishes guidelines and limitations for its

use. Further, as the cost of Federal workers’ compensation is a budget issue for the

Federal agencies, we believe an appropriations bill is the best vehicle for addressing

the issue.
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Clearly DOL cannot administer FECA absent Federal resources. If Congress decides not to enact this proposal, the Administration will work with Congress to identify alternative resources for the administrative costs of the FECA program.

MASS LAYOFFS

Question. Mass layoffs are increasing. In January alone, employers announced

1,522 mass layoffs, involving the projected loss of more than 200,000 jobs. In the

last year, 647,000 workers who lost their jobs due to mass layoffs filed for unemployment compensation. Wouldn’t it be better to increase funding for Dislocated

Worker training, instead of paying out longer unemployment benefits?

Answer. Under the Workforce Investment Act, dislocated workers receive services

designed to meet their individual needs for assistance to help them return to work

as quickly as possible. Individualized assessment of worker needs in One-Stop Career Centers helps to distinguish those dislocated workers who might return to work

with minimal reemployment assistance from those who require more extensive help.

Workers in the latter category include those with obsolete skills, with limited

English proficiency, and workers in some communities that lack a diverse economic

base.

Services for dislocated workers include a full range of activities, beginning with

computerized job matching and resume posting, and extending to in-depth assessment and occupational skill training. Although many workers’ training costs can be

supported through Pell Grants and other resources, adequate funding for Dislocated

Worker training is critical to meeting basic program goals. Our fiscal year 2002

budget request, combined with State unspent funds, will ensure that services to dislocated workers will not decrease from PY 2001.

For Dislocated Worker programs to achieve their goals of timely reemployment at

good wages, the choice is not necessarily between longer unemployment benefits and

increased funding for Dislocated Worker programs. Because workers who need additional skills to achieve quality reemployment must devote time to acquiring those

skills in lieu of working, training for dislocated workers cannot stand alone. It must

be supplemented by Unemployment Insurance (UI) benefits which provide needed

partial wage replacement so that individuals can meet current living expenses while

receiving training. The UI benefit helps reduce the financial hardship caused by loss

of employment for individuals while at the same time helping to automatically stabilize the economy. For those workers who continue in training after their UI benefits are exhausted, needs-related payments are an available resource.

QUESTIONS SUBMITTED BY SENATOR PATTY MURRAY

Question. Secretary Chao, what is the Administration prepared to do for aluminum workers and other workers in the Pacific Northwest who lose their jobs due

to the energy crisis?

Will your budget request provide sufficient resources to help workers who find

themselves suddenly unemployed given the Administration’s expressed concerns

about a potential recession?

Answer. The Department’s discretionary National Emergency Grant (NEG) program is designed to provide reemployment services, supportive services and retraining activities in response to mass layoffs and plant closures affecting large numbers

of aluminum workers and other industries. Additionally, all communities have funds

available to them through formula grants to serve dislocated workers. For example,

in PY 2000 the State of Washington received $28.2 million in formula funds to assist communities in the State in serving dislocated workers, a 103 percent increase

over the previous year’s funding under the Job Training Partnership Act. Oregon

received $30.4 million, a 72 percent increase.

EXPOSURE OF MINERS TO ASBESTOS IN LIBBY, MONTANA

Question. Are you familiar with the Inspector General’s recent report on MSHA’s

handling of inspections of the mine in Libby, and with the recommendations contained in the report? Do I have your commitment that the Department will make

it a top priority to implement the recommendations that require rulemaking as

quickly as possible?

Answer. Yes, I am familiar with the Office of the Inspector General’s (OIG’s) report of March 22, 2001, Evaluation of MSHA’s Handling of Inspections at the

W.R.Grace & Company Mine in Libby, Montana. We are extremely pleased that the

Senate has confirmed Mr. David Lauriski as the new Assistant Secretary of Labor

for Mine Safety and Health. Both he and I are committed to protecting miners’ safe-
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ty and health, including preventing their exposure to harmful contaminants such as

asbestos.

I have asked Mr. Lauriski to review the facts and the OIG’s recommendations and

consult with the affected parties to develop a course of action.

ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT (EEOICPA)

Question. Secretary, I believe you have said (McLaughlin’s ‘‘One on One’’ taped on

March 23, 2001) the Labor Department has ‘‘no capability, no infrastructure’’ to

carry out the nuclear workers compensation program.

What are your plans to develop the infrastructure so you can get this program

running?

Answer. My comments centered on the statutory deadline for the Department to

implement this large new program. This reality poses significant challenges, thus

warranting my public concern. We have been working diligently to develop the necessary regulations, organization, systems, and procedures for carrying out the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) in as

timely a manner as possible. In doing this, we have been utilizing our experiences

in administering the workers’ compensation systems for Federal employees,

longshore and harbor workers, and miners suffering from black lung. As I have explained in response to questions from other members of the Subcommittee, while

the EEOICPA has some features similar to parts of each of the programs mentioned, its provisions are sufficiently different from any of those programs that is

necessary for us to develop a separate infrastructure. Furthermore, the substantial

number of claims that we expect to be filed in the first few years also requires a

separate organizational unit, with dedicated staffing. This unit will be responsible

for accepting and adjudicating claims under the program, a responsibility which will

include determining the probability that an individual’s cancer was as likely as not

due to radiation exposures and adjudicating disputes. We have been working with

the Departments of Energy, Health and Human Services, and Justice to implement

this program in a fair and equitable manner. We will be utilizing private sector contractors as well as reaching out in a very broad way to recruit the necessary staff

to adjudicate claims and supply the necessary technical expertise in areas such as

radiation measurements and exposures.

Question. On March 9, you wrote to Mitchell Daniels, Director of OMB, that you

recommended that ‘‘the administration support technical legislation that will soon

be introduced to remedy some of the remaining deficiencies in the EEOICPA.’’ What

are these deficiencies and how do you see them remedied? What is the status of this

legislative proposal?

Answer. As enacted, the EEOICPA contains few provisions concerning administration of the program or review of decisions made on claims for benefits. In addition,

the Act also contains ambiguous or unclear provisions, some of which may have unintended consequences. The extremely short deadlines for implementing this program have required DOL to focus exclusively on efforts to promulgate regulations

and create procedures and systems necessary to undertake our responsibilities

under EEOICPA and Executive Order 13179. Thus, consideration of possible legislation must await our completion of the steps needed for the initial implementation

of the program. We do intend, however, to further review this legislation and consult with the Office of Management and Budget and other agencies with responsibility under EEOICPA to determine whether and what type of legislative proposal

is warranted.

WOMEN’S BUREAU EQUAL PAY

Question. The previous administration make bridging the wage gap a priority.

What specific steps will the Bush Administration take to solve this serious problem?

Answer. In 1963 the Equal Pay Act was passed, and since then women have continued to make tremendous advancements in the labor force. Today, women earn

more than half of all college degrees, and nearly half of all graduate degrees. With

this increased education comes increased earning power for women, and the pay gap

has narrowed significantly over time.

The Department of Labor, through the Women’s Bureau, will continue to pursue

a vigorous program of outreach to increase women’s awareness of new opportunities

for education, training, and employment. In addition, we will continue to inform employers of their responsibilities under the Equal Pay Act and to fight gender discrimination.
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YOUTH PROGRAMS

Question. The 21st Century is rapidly approaching and the skills that will be most

valuable in our country are ever changing. The workforce must, therefore, have the

ability to adjust to the times. Currently, too many Americans are left behind in this

sweeping change. The days when one could easily earn a living wage with a high

school education are rapidly diminishing. Today, workers need more education and

training to develop skills that reflect our changing economy. I am concerned that

your budget provides $222 million less for youth employment and training programs. We should be increasing not decreasing our investments that focus on one

of our most vulnerable sectors of the workforce, young people.

Fewer resources for programs like the Youth Opportunity Grants program will ensure less children are making productive transitions from school to work.

I must point out that your proposed funding request for the Rewarding Youth

Achievement Program is on the right track by focusing on children in high poverty

areas and providing them with employment opportunities they wouldn’t normally

receive. It is very important that the Department of Labor is a valued partner in

providing young people opportunities to receive needed job skills to be competitive

in the modern workforce.

Secretary Chao, what specific measures will you take to ensure these youth are

provided with opportunities to learn needed job skills? Answer. Although the fiscal year 2002 budget request provides $222 million less

for youth employment and training programs, this request does not diminish our investment in one of the country’s most valuable resources, America’s youth. In fact,

the request for WIA youth activities allows the Department to serve the same level

of youth as will be served in 2001—721,000 youth. The transition from the Job

Training Partnership Act has resulted in significant underspending as State and

local programs gear up to fully implement the numerous structural changes in the

workforce investment system under WIA. As these unspent funds are carried forward and States become fully operational, service levels will increase creating more

opportunities for America’s young people. The Department will work vigorously with

State and local communities to ensure that systems are in place to provide opportunities for young people to learn the needed job skills and receive the necessary support to achieve academic success.

SHORTAGE OF CAREGIVERS

Question. This past week, HHS Secretary Thompson testified before this Subcommittee on the need to address the current shortage of caregivers nationwide,

particularly in our Nation’s nursing homes and assisted living facilities where

there’s a shortage of 250,000 CNAs and 60,000 RNs. This Subcommittee would like

to work closely with you in the effort to address this serious problem to ensure that

the nation’s frail elderly receive quality care.

I am interested in your thoughts on ways to address this shortage of caregivers?

Answer. The Department of Labor is cognizant of the need for more caregivers

at all skill levels and is working to address this issue. For example, under the Workforce Investment Act of 1998, an eligible individual may select training in high-demand occupations certified by their local workforce investment board. Certified

Nursing Assistants (CNAs) represent an occupation that is very much in demand

in most local areas. Therefore, an individual who goes to a One-Stop Career Center

and becomes eligible for training will likely see CNA training offered as a response

to one of the occupational choices. Many One-Stop Career Centers also offer access

to training in advanced skills that require certification, such as medical laboratory

technicians, operating room technicians, and inhalation therapists.

In addition, a substantial number of the 190 Welfare-to-Work competitive grantees (representing an investment of nearly $700 million dollars over six years) offer

welfare recipients and other low-income individuals training and work experience

opportunities to gain employment as a CNA or in other health occupations.

Finally, the H–1B Technical Skills grant program provides specialized, high skill

training to American workers desiring to upgrade their skills to fill occupations that

are now filled temporarily by foreign workers. In 2001, we expect to have approximately $180 million available for the H–1B Technical Skills grants. Through this

program, the Department has recognized health care occupations, particularly registered nursing, as a specialty occupational area in high demand.

Some H–1B Technical Skills grants have focused specifically on health care training, in particular nursing training. In New York, the League/Service Employees

International Union (SEIU) 1199 Training and Upgrading Fund received an award

that proposed to train 675 employed and unemployed health care workers for high

demand nursing positions. Under another grant, the State of Vermont and the
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Vermont Human Resources Investment Council will work together to provide a mix

of on-the-job training and on-site instruction for critical care nurses to place workers

in 16 hospitals. Workforce Essentials, an H–1B Technical Skills grantee in Clarksville, Tennessee is training registered nurses.

LEGISLATION FOR LONG-TERM CARE GIVERS

Question. In the Senate, work is now underway on legislation that would provide

$500 million a year for the next three years, in grants to States, to promote the

nursing profession and to help long term care providers recruit, train, and retrain

caregivers at all levels. Would you be supportive of this approach to addressing the

caregiving shortage?

Answer. The Department of Labor is very interested in efforts to address employers’ demand for skilled workers while also providing opportunities for unemployed

and underemployed individuals to increase their skills and advance in their careers.

The Administration is particularly concerned about communities that lack access to

care and plans to reform the National Health Service Corps to better define shortage areas and target placements of non-physician providers practicing in communities.

The Administration will carefully review and consider legislation to address this

issue. Once the legislation has been reviewed, we will be happy to share our views

with you.

IMMIGRATION OF HEALTH CARE PROFESSIONALS

Question. HHS Secretary Thompson testified before this committee last week that

part of the solution might be tied to allowing more foreign nurses and health care

workers to immigrate to the United States to help fill the void. Would the Labor

Department be willing to work directly with HHS, the Department of Justice, and

the Immigration and Naturalization Service to create an immigration program that

can help meet this need?

Answer. The Department currently is administering the H–1C nonimmigrant

nurses program, which is intended to address nursing shortages in areas where

there are spot shortages. It previously administered the now-expired H–1A nonimmigrant nurses program. The Department of Labor would be, of course, willing

to work directly with HHS, the Department of Justice, and the Immigration and

Naturalization Service to develop creative ways to address this problem over the

long-term.

QUESTION SUBMITTED BY SENATOR THAD COCHRAN

MIGRANT AND SEASONAL FARMWORKER HOUSING PROGRAM

Question. In the past, this subcommittee has included appropriations report language directing the continuation of a small, but important program that assists

farmworkers in gaining better housing. Since at least 1983, I have worked with the

Department to ensure a network of local organizations, including one in my State,

receives funding to plan, develop, and manage housing for migrant and seasonal

farmworkers. There is a well established network of local housing organizations that

receive these funds.

In the fiscal year 2001 Labor Appropriations report, language was included to provide $4 million in funding for this network. This amount was an increase of $1 million over the fiscal year 2000 level. I am hopeful that the Department of Labor will

continue to support increased funding for this important program.

I look forward to working with you and the Department in the future. Thank you.

Answer. The Department of Labor will provide a total of $4 million for competitive

and non-competitive farmworker housing grant activities in Program Year (PY)

2001. Grants totaling $3.6 million will be awarded competitively to fund housing

and housing development activities for migrant and seasonal farmworkers. The Department is also funding on a non-competitive basis the Hope Migrant Rest Center

for $333,000. The Center provides overnight and temporary lodging to over 40,000

migrant farmworkers and their families who criss-cross the country in search of and

en route to seasonal agricultural jobs.

Grants to the National Farmworkers Jobs Program authorized under WIA section

167 will total $72 million for PY 2001. These programs also provide for direct assistance to eligible farmworkers for transitional, temporary, or emergency housing in

support of job training activities, or agricultural employment.

Senator SPECTER. Okay. Thank you all very much.
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Secretary CHAO. Thank you.

SUBCOMMITTEE RECESS

Senator SPECTER. The subcommittee will stand in recess to reconvene at 9:30 a.m., Thursday, May 10, in room SD–192. At that

time we will hear testimony from Dr. Roderick Paige, Secretary,

Department of Education.

[Whereupon, at 10:47 a.m., Wednesday, May 2, the subcommittee

was recessed, to reconvene at 9:30 a.m., Thursday, May 10.]
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DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

THURSDAY, MAY 10, 2001

U.S. SENATE,

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS,

Washington, DC.

The subcommittee met at 9:37 a.m., in room SD–192, Dirksen

Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Harkin, Reid, and Murray.

DEPARTMENT OF EDUCATION

OFFICE OF THE SECRETARY

STATEMENT OF DR. RODERICK R. PAIGE, SECRETARY OF EDUCATION

ACCOMPANIED BY THOMAS P. SKELLY, DIRECTOR, BUDGET SERVICE

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. Good morning, ladies and gentlemen of the

subcommittee on Labor, Health, Human Services and Education.

The Appropriations Committee will now proceed.

This is the first hearing where we have an opportunity to welcome the distinguished Secretary of Education, Dr. Paige. He

brings to this Cabinet position a very distinguished record; a bachelor of science from Jackson State University; a master and Ph.D.

degrees from the University of Indiana. He had been the superintendent of the Houston Independent School District, a job of

enormous responsibility, where he was innovative and very accomplished. He previously served as Dean of Education and Athletic

Director at Texas Southern University.

In addition to the widespread praise and reputation, he has been

awarded the 1999 Richard R. Green Award by the Council of Great

City Schools, the 2000 Harold W. McGraw, Jr. Prize in Education

from the McGraw-Hill Companies, and the 2001 National Superintendent of the Year Award from the American Association of

School Administrators.

EDUCATION BUDGET ISSUES

Dr. Paige, you come to present the administration’s budget request on a day when, as you know, the Senate is considering the

Education bill.
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Secretary PAIGE. Right.

Senator SPECTER. A very complicated matter. We have set it

aside, briefly, to take up the budget. There are nine pending

amendments. To say it is a quagmire would be an understatement.

But I have seen, in the time I have been here, that institutionally

the Senators are a lot smarter than any of the individual Senators.

I would not say that for secretaries, but for Senators and—and the

Senate has a way of working through the problems.

There are a great many subjects that we want to ask you about

today; the allocations, some of the additional programs, some of the

programs which have been cut, the problem of campus crime, the

Youth Violence Initiative which this subcommittee put into operation, the issues on class size, more teachers, and the school construction.

And I turn now for an opening statement from my distinguished

colleague, Senator Harkin.

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. Thank you very much, Mr. Chairman. And I

cannot think of a more timely time to have this hearing than right

now, when we are involved in a debate on the Senate floor on the

Elementary and Secondary Education Act reauthorization.

We welcome you, Mr. Secretary, for this very important budget

hearing. We can talk all we want to about education and how we

all love it and how we want to make education better, but if the

resources are not there, it is just more of the same old rhetoric.

Now, Mr. Secretary, I have a great deal of admiration for you

and for your background and what you have done for education. So,

I hope that what I am about to say you do not take personally——

Secretary PAIGE. I will not take it personally.

Senator HARKIN [continuing]. But take it policy-wise.

Secretary PAIGE. Yes. Thank you.

Senator HARKIN. And I had great hopes earlier this year when

President Bush was talking about leaving no child behind. When

he picked you to be his Secretary of Education, I thought we are

going to be on our way. And quite frankly, my hopes, I think, have

been dashed. The budget this year is just incredibly inadequate, in

terms of education.

SPECIAL EDUCATION FUNDING

Now, I am going to just start, first of all, by reading an article

that was in the paper this morning. Now, I do not know if it is true

or not, but I am going to read it to you.

It said—it is talking about the education plan. It said, ‘‘The administration indicated it was particularly upset—particularly

upset—by a vote last week to increase funding for schooling disabled students and to lock it into the Federal budget for the next

10 years by shielding it from the annual appropriations process. Officials described the proposal as ‘costly and unwarranted.’’’

I hope that official was not you, Mr. Secretary.

Well, after all these years, on both sides of the aisle, talking

about getting the Federal Government up to its 40 percent of the

average per pupil expenditure for kids with disabilities—and you

and I have talked about this personally in my office—the Senate
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finally, on a unanimous vote—unanimous, which means when we

offered the amendment, we did not even ask for a vote; it was

unanimous, because no one objected—unanimously said, ‘‘We are

going to appropriate, not just authorize, but we are going to appropriate about $181 billion over 10 years to meet this need.’’

And now, the administration says they are upset about it; that

it is costly and unwarranted. I beg to differ.

TAX CUT PACKAGE AND EDUCATION FUNDING

Second—or third, I guess, Mr. Secretary, the Senate adopted an

amendment that both of us supported, that would have shifted

$250 billion out of the $1.6 trillion tax cut, and put it into education. Well, the House had passed the administration’s $21.3 billion for 10 years.

Well, you would think, when it went to conference, they might

have compromised someplace in the middle. The budget we got

back is zero. The budget that we have, that we are going to vote

on today on the Senate floor, has zero increase above baseline for

education for the next 10 years. They did not even put in the President’s $21.3 billion, let alone the $250 billion that we had supported in the Senate.

And so, I would like to have your thoughts on that and find out,

well, why is not the administration saying something?

SCHOOL RENOVATION FUNDING

I am disappointed that they have eliminated the $1.2 billion fund

for school modernizations.

The American Society for Civil Engineers recently issued a report—they gave our schools a D-minus. The lowest grade of all of

the facility infrastructure in America was our schools.

Finally, the Senate and the House, last year, began the process

of reaching out to help modernize our schools, and the administration has zeroed that out.

Well, I know that money alone will not improve schools. I have

heard that all the time, but tell me how you are going to repair

a roof, if you do not have some money; how you are going to build

an extra classroom, if you do not have some money.

Sure, we want accountability, testing—I can work my way

through all of those, but if we do not have the resources in there

to build decent schools for kids, I am sorry, I am out of here. And

I just do not understand where the administration is on this.

STRATEGIC REVIEW OF EDUCATION BUDGET

Well, lastly, I just say this: Next week Defense Secretary Donald

Rumsfeld will announce the results of a strategic review of the Defense budget. And then, the President plans to submit a new budget request based on those results. And the rumors I am hearing

around here were on Defense appropriations, we are going to commit an additional $20 billion to $30 billion per year.

Why can we not do that for schools? Why would not the President have a strategic review of the education budget, and ask the

question, are all our kids ready to learn when they enter school?
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In 1989, President Bush, the Governors, we all decided on Goals

2000. We are going to meet Goals 2000 in education. First goal,

every child ready and able to learn by the time they enter school.

2000 was last year, and we are not even anywhere near it.

Are our classes small enough to promote learning? Are our

schools in good repair? Are teachers well trained?

Well, if the answers are no, why do we not have a strategic review and come back with a budget that will meet these needs? But

no, what I read is they cannot even support what we finally decided on a bipartisan basis to do. And that was to meet the needs

of special education.

So, Mr. Secretary, I have great respect for you.

Secretary PAIGE. Thank you.

Senator HARKIN. And I mean that, personally. Your background

speaks well. But I am telling you, this budget is awful, when it

comes to education. And I just hope that you will speak up and

fight as hard as you can, as a Secretary, to say that this is unacceptable to everyone.

I am sorry to be so emotional about it, but my gosh, we have got

to do something about this education budget.

Thank you, Mr. Chairman. I am sorry.

Senator SPECTER. Well, so much for the level playing field, Mr.

Secretary.

Well, Senator Harkin never minces words. We know exactly

where he stands.

In the end, we have had a record for coming together in a collegial way. And I am optimistic we will do the same thing here.

EDUCATION 302(B) CONGRESSIONAL BUDGET ALLOCATION

I might just add one more word before you begin your testimony.

We are trying to get an allocation for this subcommittee which will

accommodate the points that all sides are making, the points the

President is making, the points the Secretary is making, what Senator Harkin has in mind, what his caucus has in mind.

Without giving you the bitter experience of last year, this subcommittee set a mark at $106 billion, which was President Clinton’s figure, which was candidly more than my caucus wanted to

set, but with a lot of effort, that was established. And we re-allocated some of the priorities. And then we had a dispute, and at one

point it looked like we were going to $114 billion instead of $106

billion. And we finally ended up at a little over $107 billion.

And this year I am concerned that when we go to the floor, there

will be add-on amendments. And 13 republicans, last year, voted

with the democrats to add the funds. And as the manager of the

bill, I stuck with the figure and cast more bad votes in 3 days than

I passed in the past 19 years on my own preferences for allocations.

So, if we get an allocation which can accommodate at the start,

I think we will make some headway. Some in my caucus say, ‘‘Well,

the President will veto a bill which is too high.’’ Okay. But then

it comes back to the Congress. And what do you do from there?

With a 50–50 split, my very strong conviction is we ought to come

to terms at the outset on a total figure, and then work on the priorities as to how we meet it, as opposed to taking one amendment
255

after another, which will ultimately run the severe risk of leading

to gridlock.

With that overly long introduction, Mr. Secretary, we look forward to your testimony.

SUMMARY STATEMENT OF DR. RODERICK R. PAIGE

Secretary PAIGE. Mr. Chairman, thank you so much. And I actually benefitted from those comments. And I appreciate them. I even

appreciate the comments of Senator Harkin. I especially appreciate

his passion because I know he means that very deeply. We have

some points of disagreement on emphasis, but I assure you that I

really respect your interests in the children of America, as I do the

other members of this fine committee.

Thank you for the opportunity to testify on behalf of President

Bush’s 2002 budget for the Department of Education. As you know,

the President has made education his highest priority, and has reflected that in his budget request.

EXCELLENCE IN EDUCATION MUST BE NATIONWIDE

The reason for this is simple. There is no part of our interest

more important to the future of our Nation than the education of

our children. And fortunately, in pockets and corners around the

country, dedicated teachers in our exceptional schools are safeguarding our future by fixing and giving children rich and exciting

experiences in learning. And we congratulate them, because we

know of their dedication and commitment. And the children who

attend those schools are not being left behind.

Those schools do not represent the norm. Basically, our system

is going to be required to be fixed in order to achieve the goal of

educating all of our children. And no society has ever attempted

that before.

Most societies have even gone so far as to assign or designate

those children who should be educated and those who should not.

To say that no child should be left behind is a pretty aggressive

goal. That requires the system to work. So pockets of excellence

will not work here.

And even as we congratulate those schools that are great and

those teachers and principals and parents and PTA members who

are causing that greatness, we congratulate them, we say it is insufficient and we need to fix the system.

EXCELLENCE REQUIRES CHANGE

And so, the emphasis in the President’s budget is about reform,

about changing things. We do not think continuing on in the way

we are going will accomplish this. If things do not change, they

stay the same. And we know that the same is not satisfactory.

NAEP TESTING RESULTS—4TH GRADE READING SCORES

Last month I had the dubious distinction of participating in the

announcement of the latest results from the National Assessment

of Educational Progress in reading for our 4th grade students. And

any caring person who heard those results will agree that we cannot keep doing the same. I call it dubious, because the only news
256

that I had to comment on after the press conference was that the

average reading performance of our fourth graders had been flat.

This is shown in this chart showing NAEP reading test scores for

4th graders from 1984–1999.

FLAT READING PERFORMANCE

Now, if you bear down inside that statement that the average

performance is flat, you find that that result is from the better students getting better and the worst students getting worse. The net

result being flat reading scores.

But if you look at it from a deeper perspective, even, the students

who are doing worse are exactly the students who this bill was created to help. That is even more devastating.

So, flat performance is not good enough. And so, it requires

change.

The results of that reading assessment are even more disconcerting when we look at it from the point of view of our disadvantaged students.

I am sorry to tell you that among students taking the 4th grade

reading exam, ethnically, they are dividing themselves; economically, they are dividing themselves. Despite Federal programs designed to help the disadvantaged students, that is exactly the

group that is doing worst.

There is a decade of historic increases in funding that supports

this. We are not doing the right things or we are not doing things

right.
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ESEA SPENDING AND 4TH GRADE READING ACHIEVEMENT

The story of our investment in education can be illustrated by

this graph which shows 4th grade NAEP reading test scores for

1984–1999 and the Federal ESEA investment over the same period. It speaks for itself. Now, promoting the continuation of that

seems to me to be inappropriate.

ESEA SPENDING AND 4TH GRADE MATH ACHIEVEMENT

The story of our student performance in mathematics can be illustrated by this graph.
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FEDERAL ESEA INVESTMENT AND STUDENT ACHIEVEMENT

The charts make powerful arguments to stopping, to pausing. Let

us stop and take a look at what kind of results we are getting and

think about doing something different.

I want to say here that I know that everybody shares my passion, the Senators’ passion, and all our passion about fixing these

things, but I am just trying to call your attention to what is happening.

The story of our students’ performance tells the story. Perhaps

the most powerful one is the chart showing reading achievement

for the 4th graders as measured by NAEP test scores and compared to the Federal ESEA investment. The blue is the spending.

The red is the performance. The connection between those points

do not seem to connect. It argues, for me, to let us take another

look.

CREATING A CULTURE OF ACHIEVEMENT

I give everybody credit for wanting to do things to improve student performance. Federal funds have been forthcoming. To understand this better, I went back and read the arguments for and

against the ESEA bill in 1965 and each reauthorization thereafter.

I read the Congressional Records, the reports and looked at those

who argued for and against various points of views. I can tell you,

from that reading, that we are circling and making the same arguments and getting the same results.

While Federal funds have been forthcoming, student performance

has stagnated on the average and declined among the hardest to

reach students. The students who we are supposed to be reaching

through Title I and other Federal programs are precisely the kids

that are hurting.
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Our system is a system that has allowed elementary and secondary student performance to stagnate, while in the last few

years, the spending increase has averaged 17 percent. And when

we spend, we think that we have conquered. When we spend, we

think we have had victory. And we measure success by how much

we spend.

And I am not telling you things that are new. These things have

been said before. The General Accounting Office in 1998 said, and

I quote, ‘‘The clearest evidence about a lack of positive effect from

Federal expenditures comes from one of the largest programs, Title

I. Title I of the Elementary and Secondary Education Act is the

largest Federal elementary and secondary education grant program. Children in high-poverty schools began school academically

behind their peers in low performance schools and could not close

these gaps as they progressed through school. In addition, when assessed according to high academic standards, most Title I students

failed to exhibit the reading and mathematics skills expected of

their respective grade levels.’’

This is the goal we said we were going to accomplish in 1965. I

can say that from reading the history.

Now, what should we take away from this lesson? Simply put,

we know that spending more on the same thing is not the answer.

We need to do things differently to adopt a culture of achieving in

our schools and school systems, and to demand results from our

growing investment. We also need to continue to invest in those enterprises that work.

GUIDING PRINCIPLES OF EDUCATION CHANGE

And I am proud to appear before you on behalf of the administration’s budget to make the point about some principles that work.

I know they work. I personally participated in them.

HOUSTON INDEPENDENT SCHOOL SYSTEM

I used them to improve the seventh largest public school system

in the United States that resides in the fourth largest city in the

United States that is populated by poor children. The school district that has converted itself from a district with minorities to a

district of minorities; a district with 73 percent free and reduced

lunch eligible students. These simple principles——

Senator REID. I did not understand that. Seventy-three percent

of what?

Secretary PAIGE. Seventy-three percent of the 210,000 to 215,000

students are eligible for free and reduced priced lunches, which is

a criterion or indication of being poor.

And by the way, it is probably higher than that, because we

know that middle school students and high school students, traditionally, do not register for free and reduced priced lunches, even

though they are eligible in many cases.

ESEA REAUTHORIZATION

You and your colleagues are in the midst of a critical debate over

the reauthorization of the Elementary and Secondary Education

Act and the substitute to be offered by Senator Jeffords, the Better
260

Education of Students and Teachers Act. That is pending before us,

now.

PRINCIPLES OF EDUCATIONAL CHANGE

I will not bore you with these principles, because I know that you

have heard them before. I will just briefly list them—accountability, flexibility, allowing the principals at the—the principal and

the other people, not just the leader of the school—but all the people at the site to make decisions and to have control over matters,

doing things that work, not funding failure.

Many people are doing the same thing over and over again.

When I became superintendent of the Houston Independent School

District and looked at the Title I programs, we had to call a moratorium on doing the same thing, and to say, ‘‘If you did this last

year and this is your results, we are not going to allow you to do

it this year.’’

And so the momentum of this continue-to-do-the-same-thing is so

powerful, that it takes effort to stop it and put something new

there. And this is not about money. It is okay to spend all the

money in the world we have got, but it is about our children, who

are not gaining with this principle. That is the point.

The budget is the argument, but the point is our students are not

growing. And we need to figure out a way to deal with that.

Reading is a particularly difficult problem. It is the foundation

of learning. And when students cannot read, the rest of it is all of

no value.

Expanded parental options. We could argue politically about this.

And there is no reason to beat a dead horse, but nobody has answered the question, what do you intend to do with students who

are failing in a failing school? If a school has failed and failed and

failed, what do you intend to do about the students?

The only answer I have heard is: Continue to fix the school.

Favor the system over those kids. I argue passionately against

that—I do not think any principle is more important than fixing

the kids.

FAILING SCHOOLS—CUMULATIVE EFFECT OF ACHIEVEMENT GAPS

When we look at the Sanders’ study, it tells us that these kinds

of gaps are cumulative, which means the student who has an ineffective teacher for 1 year, and then the second year has a very effective teacher, still the gaps created by the ineffective teachers

cannot be covered up. This gap is continuing. So, we go through 2,

3 years of ineffectiveness? What do we intend—what do we do with

the students who are not growing in this environment? It seems to

be the most important question we could ask.

You know the numbers better than I. So, I will not bore you with

these numbers. I will quickly bypass them and go to the end of this

presentation.

DEBATE REFORM AND PRINCIPLES OF REFORM, NOT BUDGET

I know the President has provided in his budget expanded funds.

And I believe that he is amenable to increasing the spending of

funds, but the question is not allowing the discussion to be
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switched from reform. Reform is the issue. Funding is not the

issue. If funding were the issue, we would not be arguing now. Reform is the issue. The debate is about reform, not about funding.

I am about finished. Overall, you know the numbers in the President’s budget better than I, but I do want to emphasize that the

President has put terrific emphasis on the critical skill of reading.

And we intend to make that work.

I referred, already, to the charts that you saw before you, but I

want to do so, again, because I want to underscore that if money

alone were the answer to our education dilemma, we would not be

here today.

You are considering this budget in the context of a debate about

reform. And that will make all the difference in the world for our

children. The same is not true for other Department of Education

programs, other than elementary and secondary programs. Money

alone will not result in a system change. And no matter how much

we spend, we cannot measure success that way.

I urge you to give the President’s reform proposals very careful

consideration. And I will end by making this observation—and I

apologize, at first, for continuing to refer to myself as a Houston

public school administrator. I was drafted for that job. I did not ask

for it. But once I had accepted the responsibility for the management of that system, the seventh largest public school system in

the world, I was intent on making it work.

And it was disconnected from the public. By that, I mean the

public had very little confidence in this system. And for 3—no, 4

straight years, we did not go back to the public, we decided not to

ask the public for additional funds. So, there was no tax increase

at all, although we grew, the public schools student population

grew.

I want to make the point that we can reform the system without

going back for additional dollars; using inside funds; redistributing

these funds, and using them in a more effective way.

And after 4 years of that—each year, coming back and showing

improvement as we went—when we did have to go back to the public to build buildings, we were successful in raising the funds. The

public had turned down a $391 million bond issue 3 years earlier,

which was the greatest lesson in my life, because if they had

passed that bond issue, I would have spent 3 years building buildings.

They defeated that bond issue and I spent that next 3 years

building the confidence of the public in the public school system.

I spent 3 years building relationships. And I spent 3 years building

productivity and efficiency inside the system.

And 3 years later, I went back to the public with a bond issue

twice that size, with $678 million, the largest ever in the history

of our State, and said, up front, ‘‘It will cost you 5.5 cents on the

tax rate.’’ And in Texas, you do not say ‘‘taxes.’’ We stood out, publicly, and said it loud.

Seventy-three percent of the public voted to support that bond

issue. All segments of the public; people who did not have children

in our schools; from both sides of the political spectrum; from labor

and from management, every segment supported it, because they

had confidence in what we were doing.
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HOUSTON SCHOOL SYSTEM REFORMS AND PUBLIC OPINION

Senator SPECTER. Mr. Secretary, what reforms did you initiate in

the interim to lead to that change in the public attitude?

Secretary PAIGE. The first reform, Senator, was to accept responsibility for student learning. It was to hold people accountable and

to administratively arrange a relationship between the leaders of

our schools—the managers, the principals—and connect in that

way to increase their productivity; rearranging their contracts, so

each had contracts just like I had, which almost was a public service—a public sector contract, because the board could change it at

any moment. They did not have the political cover of going to their

board members or other people like that. That was the first one.

The second one was to set real clear, crisp standards and continue to remind them of those standards. In every school that you

went to, there was a graph on the wall saying, ‘‘Here is where you

are, now. And here is where you are going to be 4 years from now.

And here is what annual progress means, where you will be next

year.’’

So, we listened to the public, talking to the community groups,

the business community, the faith-based community, the ethnic

groups, NAACP, LULAC, all of those, getting all of these people involved.

I do not mean to imply that we licked this thing. I am just saying

that we had progress and the progress was built on the common

practice of listening. We stopped talking about money, started talking about productivity, and showed the results to the public.

And by the way, even when we made mistakes, we would go to

the public and say, ‘‘We made this mistake.’’ We stopped making

excuses about mistakes. When something went wrong, we stood up

in front of them and said, ‘‘We did this wrong. We will do it better.’’

We did a lot of different things, like simply taking responsibility,

setting high standards, measuring results, reporting those results

to the public, calling our administrators in and letting them know

feedback on how they were performing.

PREPARED STATEMENT

Senator SPECTER. Mr. Secretary, your full statement has been received by the committee and has been studied and fully made a

part of the record, if it is acceptable to you.

Secretary PAIGE. It is.

[The statement follows:]

PREPARED STATEMENT OF DR. RODERICK R. PAIGE

Mr. Chairman and Members of the Committee: Thank you for this opportunity to

testify on behalf of President Bush’s 2002 budget for the Department of Education.

As you know, the President has made education his highest priority, and this priority is reflected in his 2002 budget request.

The reason for this is simple: there is nothing more important for the future of

this great Nation than the education of our children. Unfortunately, our system of

education is failing too many of those children. Earlier this month, the latest results

of the National Assessment of Educational Progress (NAEP) showed that the average reading performance among our fourth graders has not improved since 1992.

And when 37 percent of our 4th-graders—and nearly half of inner-city 4th-graders—

are unable to read at even the NAEP Basic level, our education system is broken

and needs repair urgently.
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President Bush and I are especially concerned about the persistent gaps in

achievement between poor and minority students and their more advantaged peers.

For example, the NAEP results showed that in 4th grade reading, 73 percent of

white students performed at or above the basic level, compared with just 42 percent

of Hispanic students and only 37 percent of African American students.

This disappointing performance comes after nearly two decades of national attention on education reform and a dozen years of rapidly increasing Federal spending

on elementary and secondary education. Simply spending more money in the same

way is not the answer. We need to do things differently, to adopt a culture of

achievement in our schools and school systems, and to demand results for our growing investment in education.

That’s why I’m especially proud of the President’s 2002 budget request for education. It provides a budget authority increase of $4.6 billion, or 11.5 percent—the

largest increase of any cabinet-level agency—and a $2.5 billion or almost 6 percent

increase over the 2001 program level. This increase is particularly impressive in the

context of the President’s overall effort to restore discipline to discretionary spending over the next decade while delivering an across-the-board tax cut benefiting all

American families.

Even more important, these new dollars are focused on changing the culture of

our education system and closing the achievement gap. Our budget reflects the principles put forward in No Child Left Behind: high standards; annual testing of all

students in grades 3–8 in reading and math; increased accountability for student

performance; a focus on research-based practices—particularly in teaching reading;

reduced bureaucracy and greater flexibility for States, school districts, and schools;

and expanded options for parents to make choices for their children’s education.

CLOSING THE ACHIEVEMENT GAP

President Bush believes that the Federal government can, and must, help close

the achievement gap between disadvantaged students and their peers. The primary

means toward this goal is the Title I Grants to Local Educational Agencies program.

We are requesting $9.1 billion for this program, an increase of $459 million, to give

States and school districts financial support to turn around failing schools, improve

teacher quality, and ensure that all students meet State academic standards before

advancing to the next grade.

No Child Left Behind provides a new framework of accountability for ensuring

that the Federal investment in Title I is well-spent and delivers the results intended

when it was first authorized 36 years ago: closing the achievement gap between poor

children and their more advantaged peers. The foundation of this new accountability

framework is annual State assessments in reading and math for all students in

grades 3–8, instead of the current law requirement for testing only twice during

these critical formative years. The President’s budget provides $320 million to help

States develop and implement these additional assessments.

I know many in Congress have concerns about these new assessments, but I can

tell you from my own experience that there is no substitute for annual information

on how well students and schools are performing. Children in good schools make

remarkable progress during these early grades, and we cannot afford to wait three

or four years to find out that some students have fallen behind. Where there are

problems, they must be discovered and addressed immediately, an approach that

can only be accomplished with the information provided by annual testing.

Moreover, these tests are essential if we are to set clear goals for performance and

help our schools get the job done. The alternative is to continue to rob millions of

poor and disadvantaged young Americans of their futures by failing to provide them

an effective education.

The important thing about testing, of course, is what we do with the results. We

would start by helping teachers learn to use data effectively. Secondly, we would

require schools to report assessment results for all students to parents and the public. School districts would use these results to make sure that all schools and students are making adequate yearly progress toward State content and performance

standards, and that no groups of students are left behind.

Under No Child Left Behind, schools would be identified for improvement after

just one year of failing to meet State standards. And unlike the current system,

where about half of schools identified for improvement receive no additional assistance from their State or district, we would require States and school districts to provide these schools with technical assistance grounded in scientifically-based research. The $9.1 billion request for Title I Grants to Local Educational Agencies includes $400 million, an increase of $175 million or 78 percent, to help pay for these

efforts to turn around low-performing schools.
264

If the school still has not improved after two years, it would be identified for corrective action and subjected to more comprehensive measures, such as implementation of a new curriculum, intensive professional development, or reconstitution as

a public charter school. While such measures are underway, students would be

given the option of attending another public school not identified for improvement

or corrective action.

Only after all these efforts, and following three full years of poor performance—

during which time a student may well have fallen behind a grade or two—would

we use Federal funds to help that student find a better education at a private

school. We are proposing to permit the use of Title I funds to help students transfer

to a higher performing public or private school, or to obtain supplemental educational services from a public- or private-sector provider. I know there are disagreements about methods of reform, but surely everyone can agree that no child should

be trapped in a persistently failing school.

Taken as a whole, these proposals reflect what I believe is a strong consensus,

both within the Congress and among the American people, that States, school districts, and schools must be accountable for ensuring that all students, including disadvantaged students, meet high academic standards. At the same time, we recognize that it is unfair to demand accountability without enabling success. This is why

the 2002 budget supports other proposals in No Child Left Behind that would give

States, school districts, schools, teachers, and parents the tools and flexibility to

help all students succeed.

For example, the President’s Reading First program would help States and school

districts implement comprehensive reading instruction grounded in scientificallybased reading research for children in kindergarten through third grade. The budget

includes $900 million for Reading First State grants, more than triple the 2001 level

for reading instruction. The request also would provide $75 million for Early Reading First, an initiative that would complement Reading First State Grants by supporting model programs to develop the academic readiness of preschool-aged children. Over 5 years, the President would invest more than $5 billion to ensure that

every child in America can read by the 3rd grade.

We also are requesting $846 million for 21st Century Community Learning Centers to support a State formula program that provides high-quality extended learning opportunities after school and during the summer, particularly for children in

high-poverty and low-performing schools. And a $30 million request for our Transition to Teaching proposal would help school districts recruit, prepare, and support

a wide range of talented career-changing professionals as teachers, particularly in

high-poverty schools and in high-need subject areas.

EMPOWERING PARENTS WITH CHOICES

President Bush and I believe that one of the best ways to improve accountability

in our schools is to give parents the information and options needed to make the

right choices for their children’s education. This is why, for example, the accountability proposals in No Child Left Behind include school-by-school report cards and

give students in failing schools the option of transferring to a better school. In addition, the 2002 budget request includes the following:

The President is proposing to increase the choices available to parents through

a new $175 million Charter Schools Homestead Fund. The program dollars will be

used to provide grants to leverage funds to build, lease, purchase, or renovate facilities for use by charter schools. A $200 million request for the regular Charter

Schools programs, an increase of $10 million, would support approximately 1,780

new and existing charter schools that offer enhanced public school choice and have

the flexibility to offer innovative educational programs in exchange for greater accountability for student achievement.

The President is also proposing a tenfold increase in the annual contribution limit

for education savings accounts, from $500 to $5,000. Parents would be able to make

tax-free withdrawals from these accounts to pay for elementary, secondary, college,

and after-school program expenses at both public and private schools.

EXPANDING FLEXIBILITY AND REDUCING BUREAUCRACY

The Administration believes that it is possible to achieve better results by reducing regulations, paperwork, and bureaucracy and giving States and communities the

flexibility to create their own innovative solutions to challenges in education.

For example, the $2.6 billion State Grants for Improving Teacher Quality proposal

would combine funding from several existing education programs, including the

Class Size Reduction and Eisenhower Professional Development State Grants programs, into performance-based grants. The proposal would provide a $375 million
265

or 17 percent increase over the antecedent programs to help States and local educational agencies (LEAs) fund their own needs and priorities in developing and supporting a high-quality teaching force. Similarly, the $817 million Educational Technology State grants proposal would

consolidate all of the Department’s current educational technology programs into a

single, performance-based grant program to ensure that schools use technology effectively to improve teaching and learning. And our $472 million request for Choice

and Innovation State grants would combine overlapping and duplicative programs

into one flexible grant program to help States and school districts implement their

own innovative strategies, including school choice, for improving student achievement.

OTHER KEY ELEMENTARY AND SECONDARY PROPOSALS

The President’s budget includes a $1 billion increase for the Special Education Grants to States program, for a total of $7.3 billion. This is the largest increase in

this program ever requested by a President, and would provide an estimated $1,133

for each child with a disability. That is approximately 17 percent of the national

average per-pupil expenditure—the highest level of Federal support ever under the

Individuals with Disabilities Education Act.

We also are requesting $644 million for Safe and Drug-Free Schools State grants

to provide students with more effective drug- and violence-prevention programs and

to implement strategies to improve school safety. No Child Left Behind includes proposals designed to strengthen the ability of schools and teachers to prevent violence

in our schools, and our budget proposal would provide flexible Federal resources to

help make our schools safe and drug-free.

The President’s Budget also supports a significant increase in the Impact Aid program, which provides financial assistance to school districts afffected by Federal activities. The $137 million increase for Impact Aid Construction would greatly expand support for the renovation and repair of schools that serve large proportions

of military dependent students and students residing on Indian lands.

In addition to our discretionary request, the President’s budget includes tax proposals that would significantly benefit elementary and secondary education. I have

already mentioned our plan to expand tax-free Education Savings Accounts to increase the educational choices available to parents. Another key proposal would

allow States to issue tax-exempt private activity bonds for constructing public elementary and secondary schools. Current law does not exclude from income the interest on such bonds used to finance school construction. Private entities would construct, own, and maintain the schools.

We also would allow teachers and other elementary and secondary school professionals to treat up to $400 in out-of-pocket classroom expenses as a non-itemized,

above-the-line deduction beginning in 2002. Expenditures for books, supplies and

equipment related to classroom instruction and for professional training programs

would qualify for this deduction.

POSTSECONDARY EDUCATION

No Child Left Behind is focused on elementary and secondary education, but the

2002 request also demonstrates the President’s commitment to preparing low-income and minority students for postsecondary education, strengthening financial aid

programs that help students and families pay rising college costs, and building the

capacity of postsecondary institutions serving large proportions of minority students.

For example, we are proposing a $1 billion increase for Pell Grants to support a

maximum grant of $3,850—the highest ever—and to improve access to postsecondary education for economically disadvantaged students. Overall, the President’s

budget would support a total of more than $49 billion in student financial aid, an

increase of $2.2 billion or 4.6 percent over the 2001 level, for an estimated 8.2 million students and parents.

To help low-income students prepare for, enroll in, and complete a college education, we are requesting a $50 million increase for TRIO outreach and support

services. We also are seeking a $15 million increase for Historically Black Colleges

and Universities and a $4 million increase for postsecondary institutions that serve

largely Hispanic populations.

We would encourage more college students to pursue teaching careers in highneed areas by expanding loan forgiveness for math and science teachers serving lowincome communities from $5,000 to a maximum of $17,500.

We also would permit tax-free distributions from Qualified State Tuition Plans

(QSTPs) to pay higher education expenses, including room and board, tuition and

fees, and certain expenses for books, supplies, and equipment. In addition, private
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educational institutions would be permitted to establish qualified prepaid tuition

plans, provided they are eligible to participate in Federal financial aid programs

under Title IV of the Higher Education Act of 1965.

CONCLUSION

The President’s 2002 budget request for education, in tandem with the education

reform proposals contained in No Child Left Behind, support a comprehensive vision

for closing the achievement gap and improving the quality of education for all Americans. I urge you to give these proposals careful consideration, and I stand ready

to answer any questions you may have.

Senator SPECTER. I would like to begin, now, the round of questioning by the Senators.

Secretary PAIGE. Thank you.

Senator REID. Mr. Chairman, if the chairman yields, I would ask

consent of the subcommittee that I be allowed to submit my statement for the record and questions. I am going to have to depart for

other places.

Senator SPECTER. Your statement will, without objection, be

made a part of the record. Are you asking to question out of turn?

Senator REID. No. I do not want to question out of turn. I will

submit some questions in writing.

Senator SPECTER. Of course. Of course, Senator Reid. That will

be acceptable. And I am sure the Secretary will respond in writing.

[The statement follows:]

PREPARED STATEMENT OF SENATOR HARRY REID

I want to thank Chairman Specter and our distinguished Ranking Member, Senator Harkin for holding this hearing on the Department of Education’s budget.

Education is so vitally important—it impacts every aspect of our lives. There are,

therefore, many issues I could discuss with you today, but I will focus on only a few.

I am troubled by the fact that the budget that President Bush sent to us—and

the budget that he has asked Secretary Paige to defend—

—has nothing for school construction,

—has no increase for after school programs,

—has no targeted class size reduction funding, and

—has nothing for dropout prevention.

Senator Bingaman and I have long supported a national dropout prevention program. Last year, Congress recognized the importance for such a program and we

included funding in the appropriations bill. This year, we have again introduced our

bill, S. 102, the Dropout Prevention Act.

The aim of this bill is to encourage innovative thinking by the States and local

school districts regarding dropout prevention, and to provide the funds if schools

wish to start a similar program in their school. To help restructure the schools with

the highest dropout rates in each State, this legislation would create a coordinated

national dropout prevention program.

Over half a million high school students drop out each year, joining almost 4 million young Americans who lack a high school degree and are not in the process of

getting one. Unemployment rates of high school dropouts are more than twice those

of high school graduates.

—The probability of falling into poverty is three times higher for high school dropouts than for those who have finished high school.

—If we do not address the dropout problem in this country now, we will be faced

in the future with a weak and uneducated workforce.

—By keeping kids in school, we are attacking much larger social and economic

issues.

Earlier this year, I was pleased to learn from Secretary Paige that he supported

a similar program when he was in Houston.

The Education bill that we have on the floor right now authorizes $250 million

for the dropout prevention program. I urge the Committee to fund this program and

I urge the Secretary and the President to support such funding.

Thank you.
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SCHOOL CONSTRUCTION FUNDING

Senator SPECTER. Mr. Secretary, let me begin the round of questions. We do not have the lights on, which is a little difficult, because—not for you, Mr. Secretary, but for the members that cannot

see when it is turning to yellow and when it turns to red. So, we

will hand members slips when we come to 4 minutes and when we

come to the end of the time. And as is our practice, I, as Chair,

will begin the round of questioning.

And let me start with the issue of school construction, which is

going to be a matter to be voted upon by the Senate. And there are

differences of opinion, different gradations. And the National Center for Education and Statistics, in a 1999 study, found that $127

billion was needed for repairs, renovation, and modernization of

America’s schools.

Now it is true that the lion’s share of responsibility is on the

State and local government, but the prior administration had a

program for school construction. It ended up, last year, differently

from my preference. My preference was to direct the funds, about

$1.3 billion, for school construction, but if the local boards met certain standards, then to have flexibility and allow the local boards

to do what they chose with that money and not use it for school

construction.

FEDERAL ROLE AND SCHOOL CONSTRUCTION

Now, I have a two-point question for you, Mr. Secretary, on this

subject. If the Federal Government is not to take a leadership role

in school construction, and knowing that the States and local governments have allowed the school buildings to deteriorate, where

will we find some relief? Let me start with that question, without

adding a second.

Secretary PAIGE. Mr. Chairman, I have to agree with you that

the condition of our buildings across the United States is really deplorable in the main. And I guess at some point we would be benefited by a great debate about what the Federal role is in public

education. I am not taking any particular position on that, now.

In fact, when President Kennedy—I mean, President Clinton proposed the legislation on school construction several years ago, as a

big city superintendent I came to testify in favor of the bill, because

that——

Senator SPECTER. Is that still your position?

Secretary PAIGE. No, it is not. And it was because I had a construction problem in Houston. And we had calculated that we

would get somewhere in the neighborhood of $200 million, or something like that which would have been there to help us. We needed

it badly. And it was my position, then, that that was something

that we should do.

So, I can understand, clearly, people arguing both sides of this,

but——

Senator REID. Mr. Chairman, but he is not for or against it at

this stage. Is that what he said?

Senator SPECTER. He is against it. He had been for it, as superintendent of the schools of Houston, but as Secretary of Education,

he is against it.
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Now, why, Mr. Secretary? Because you think it is not the Federal

role?

Secretary PAIGE. Well, that is—that is one thing, Mr. Chairman.

I think that we need to examine to determine where the Federal

role starts and ends, because I do not know if the Federal Government is capable of managing this one.

Here is my rationale. The $1.2 billion that was allocated for this

purpose, under the previous administration, would not have repaired the buildings in the Houston Independent School District 3

years ago. So, today, it would cover, maybe, 75 percent of them.

Senator SPECTER. Well, how about the leadership role of the Federal Government, Mr. Secretary? If we—my idea in the current bill

is to have an allocation for school construction, but if the local

boards decide that they have some greater need, to give them the

flexibility.

So, in effect, it is a rebuttable presumption. And it provides some

continuity, even though we do not have the Clinton administration,

we have the Bush administration, but to meld the two on some central ground and say, ‘‘We would like to continue this, but it is up

to you, if you think you need the money somewhere else more urgently.’’ Why not that approach, Mr. Secretary?

Secretary PAIGE. Well, Mr. Chairman, I am not prepared to debate that approach, because I think there is some thought behind

that. And I think there is great merit there. However, it differs a

little bit from my point of view, because my point of view is about

managing the construction issue from this level. And it is going to

be extremely difficult.

How do we choose among these great needs all the way across

the United States?

Senator SPECTER. Well, we certainly have the—let me move to

the other question, because I have got 20 seconds left, and that will

be time for me to state the question and you can give the answer,

but not on my time.

FLEXIBLE TEACHER FUND AND CLASS SIZE REDUCTION

Teachers. The same thing. $1.3 billion last year. Class size. Senator Murray has offered an amendment. And I have made what we

call a second-degree amendment to make it presumptive, yes, for

teachers, but again, if the districts decide something else, they can

do as they choose.

My red light is on. I am nine seconds over. Now, we will listen

to your answer, Mr. Secretary.

Secretary PAIGE. Okay. Was that last point about the teachers?

Class size reduction was to increase more teachers?

Senator SPECTER. Yes.

Secretary PAIGE. Allow me, once again, to rely on my experience.

Okay. When we looked at that from Houston’s point of view, the

first thing we found out was that we had no space to add additional classrooms for the additional teachers.

The next thing we found out was the funds would only pay salaries of first-year teachers. So, that further handicapped us. The district and the State had already reduced class sizes. So, we were

handicapped in that regard.
269

We wanted to use those dollars to ensure improved student

achievement, but the regulations were so stringent that the flexibility to do that was difficult.

Now, I will confess, now, that we got around it, but the way we

got around it, I would say, was dubious. We went around by using

a very crisp understanding of what the regulations said and getting

ready to debate that at some point, because we thought that we

might get it done that way, but the regulations tied our hands. We

found a way to use the money, but the regulations tied our hands.

We would have been better off if it had come to us the way that it is packaged in the President’s budget now, with $2.6 billion for

teacher quality, which allows the district to make decisions about

how to increase teacher quality. We should not just take the concrete, specific, limited concept that if you have more teachers, the

situation is better.

It is much more complicated than that. And it is tied almost exclusively with teacher quality. Are the additional teachers better,

or are they worse? Can you get better teachers?

We would like to use the money, maybe, to take the teachers we

have and send them off to be trained. Or we may like to take some

of the money to go to Mexico and to recruit more teachers who

have dual language capabilities. You cannot know that. Only we

could know that.

So, the flexibility to use those dollars, as it is packaged in the

President’s budget, is much preferable to all of the big city superintendents that I have talked to and all of the rural superintendents that I have talked to.

Senator SPECTER. Senator Harkin.

SCHOOL CONSTRUCTION FUNDING

Senator HARKIN. Thank you very much, Mr. Chairman.

Mr. Secretary, permit me, a little, to tarry along the construction

situation.

Secretary PAIGE. Okay.

Senator HARKIN. I first started proposing this in 1991, and then

in 1992, and then in 1993. And finally, in 1994, when I held the

chair that Senator Specter does now, and he was ranking member,

I got through $100 million in appropriations to put out a pilot program for construction. That was 1994.

In 1995, the Clinton administration rescinded it. So, there you

go. You can say now you agree with the Clinton administration. He

rescinded it. I was furious. Furious. It was not the Republicans

that did it. It was the Clinton administration that rescinded it. You

know that as well as I do.

So, I tried again, year after year, to get this thing going again.

Finally, dragging, kicking and screaming, we got the administration to support it last year. And we got $1.2 billion into school construction. And I have got a list of how much has gone out to the

States.

That is just a little bit of the background for you, where this is

coming from.

In the meantime, after the President rescinded that in 1995, I

said, ‘‘Well, I believe this will work. There is a great need, and it

will work.’’
270

So, for 3 years in a row, we got money through the Appropriations Committee to go to my State of Iowa for construction grants.

It went to the State Department of Education with broad guidelines. We did not give them every jot and tell them exactly how to

do it.

We just said, ‘‘Here is the money. Broad guidelines. Target the

poorest school districts.’’ That is all we said. So, it went out to the

Iowa State Department of Education.

LEVERAGING FEDERAL FUNDS—SCHOOL CONSTRUCTION IN IOWA

Now, Mr. Secretary, $28 million has gone out to Iowa for that.

Now, hang on to your hat. That $28 million leveraged $311 million

on the State and local level.

One of the things that we know about the Federal Government

is, sometimes money can leverage money. And anytime you get 10

to 1 leverage on Federal dollars, something is happening out there.

What the State Department of Education said was, ‘‘We will do

matching on it. And you can raise money through a bond issue,

sales tax.’’ We have local option sales tax for plant and equipment,

the different things that local units of government can do in the

State of Iowa.

With that little bit of money—with that little bit of money, they

stepped forward and did it, and leveraged it over 10 to 1. And I

have got the data to prove it.

You said two things. The Federal Government is not capable of

administering this.

Secretary PAIGE. No. I mean——

Senator HARKIN. Well, I wrote it down.

Secretary PAIGE. Yes. I probably did say that, but I mean solving

this problem. I did not mean administering.

Senator HARKIN. Oh, well, you said ‘‘administering.’’ I just want

you to know, we did not administer it in Iowa. We let the State

Department of Education in Iowa do it.

Secretary PAIGE. Yes.

Senator HARKIN. And the legislation that we have now, the same

thing; that would be our guideline. It is going to go out to the State

Departments of Education in Pennsylvania and Washington and

every other place. And we are just going to give them a broad

guideline, target it to the poorest districts——

Secretary PAIGE. Yes.

Senator HARKIN [continuing]. And let each State do it in their

own way. So, we do not have a problem of administering it. It is

administered in Iowa by the Iowa Department of Education. And

it has made a huge difference. Go out and ask those school districts

out there what it has done in terms of leveraging that money.

So, when you talk about $1.2 billion will not repair three of your

schools in Houston, when it all factors out, that is probably true,

if you are talking about the totality, but think about it in terms

of how much it leverages out there. If we can just get two-thirds

of that leveraging nationwide, from $1.2 billion, you are talking

about $7 billion, $8 billion, $9 billion. Now that makes an impact.

So, there is a history here to this. And there is some proof of concept out there that we have gone through. And that is why I hope
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that your initial support of this, you would revisit, and come back

again, Mr. Secretary.

Secretary PAIGE. Well, that is what I want to do, Senator, to put

emphasis on our education situation.

And by the way, I would like the record to show that, if I am

permitted to, I do not mean administering. I used the wrong word

there. What I mean was solve it. I meant that this problem is so

vast it is going to need the locals to address it, as you have indicated that they are doing.

Senator HARKIN. They do have to address it, obviously, but we

are going to give them a little bit of help to move them along. That

is the leveraging aspect of that money that goes out there.

IMPACT AID CONSTRUCTION

Secretary PAIGE. But there is a place where we have the direct

responsibility. And I think the Federal Government has a direct responsibility for school districts that are impacted by military enrollment of our students. I think that is a primary direct responsibility

of the Federal Government in terms of construction.

And when we look at the conditions of the buildings in those

locales, I think that we find that we have an even greater problem

there.

And the second one would be on Indian reservations. It is those

areas, where I would agree that we need to have a specific Federal

focus on the construction of buildings.

So, there is not that much difference here in the argument.

There are places where we have direct responsibility that I think

we should take care of first.

Senator HARKIN. Well, I agree that we need to do something in

those areas, but—on the school districts in the military and stuff,

why should that not also come out of the Defense budget? Why do

we have to take that out of the Education budget? Put it in the Defense budget. That is where it ought to be done. That is my response to that.

We have got an obligation. You are right. But I think this is a

military obligation that they have.

Thank you, Mr. Secretary.

Secretary PAIGE. Thank you.

Senator SPECTER. Thank you very much, Senator Harkin.

Secretary PAIGE. Thank you for your passion in this matter. I

know it is important to you.

Senator HARKIN. Yours, too. Yours, too. You have got good passion, too.

Senator SPECTER. Senator Murray.

Senator MURRAY. Thank you, Mr. Chairman.

And clearly, Secretary Paige, you have a passion for making sure

that all of our students get a good education. And I really commend

you on that. And I have spoken to you a number times on this,

both in my capacity on this committee and on the Authorizing

Committee. And I appreciate your being here today and showing

us, once again, your passion.

I have to just quickly add on school construction—that I am delighted to hear you say that we should be funding military impacted schools, because I have been fighting to help some impacted
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schools in my State and cannot get anything from the Defense Department on this. They absolutely say it is hands-off. And I agree

with Senator Harkin that this is an issue we need to deal with, but

it is an issue we need to deal with for all children.

Let me go back to the issue of class size. The Chairman began

this hearing with a question on this, and I heard your response

about hiring only first-year teachers. The only requirements within

the class size bill is that teachers hired are fully qualified, not that

they are first-year teachers.

So, I am not certain where you were coming from on that, but

I can certainly tell you if there is a misunderstanding with that,

then we need to deal with the language. Let us not throw the program out. Let us figure out what the language needs to be.

And second, we have worked very hard with Senator Specter,

Senator Harkin, and a number of people on both sides of the aisle

to develop language for the very successful class size program, to

assure that it is flexible; that if a school district has met their class

size goals in first, second and third grade, then the money can be

used for teacher training and for other purposes.

And I want to thank Senator Specter, publicly, for his interest

in this. I have seen his second-degree amendment. And I hope we

can work something out on this, because I think that as we see the

studies that come to us, we see the progress that has been made

on class size, we see that this is a way to leverage Federal taxpayer

dollars to actually make a difference in students’ achievement; in

their math, in their science, in their reading scores.

We have seen, through various studies, that smaller classes

make a difference in dropout rates and the number of students

going on to college, and even teen pregnancy rates, even if it is just

in those first, second and third grades, where our kids are just beginning to learn the basics, that they get the individual attention

they need. And yes, it is the responsibility of the Federal Government to be a partner, to make sure that our local school districts

have the ability to create smaller classes.

In fact—I have to say, I am sort of baffled by your conversion,

as Secretary of Education, from where you stood on this issue were

as Superintendent of Houston schools, because I know that in presentations by your advisor, Susan Sclafani, about how Houston

closed the achievement gap, certainly setting out the goals and

where you wanted kids to be—and telling people they had to be accountable was part of it.

But clearly, she has said that targeting assistance to low-performing schools was important—and she specifically has said, that

adding teachers to lower pupil-teacher ratio was a critical part of

making sure that those students achieve.

We believe that closing the achievement gap is a laudable goal,

and one that many districts are struggling to reach. The class size

dollars that we have put in place over the last 3 years have come

back to us, triple-, quadruple-fold from results in districts where

teachers and parents and students are saying what a tremendous

difference smaller classes have made for them.

Because I have been on a school board, I know how hard it is

to find the funds for long-term commitments like hiring more
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teachers. I know how many demands there are when it comes to

budget time.

The Federal class size dollars go directly to these school districts

with the least amount of paperwork and the most flexibility, ensuring that students are able to get the kind of help they need. And

we want to continue to leverage that. And we want to continue to

build on that success. And I hope that I can work with you to make

that happen, because I think it is absolutely critical to our children’s success.

And I hope you can comment on that really quickly, because I

do have a very important question about the chart that you have.

Secretary PAIGE. Well, Senator, you make a very powerful argument. I find very little in your comments to disagree with. My only

point is the categorical nature of the way the dollars are provided

for the system.

I believe the people on the scene should be able to make the decision on how those dollars are used. And we should provide them

with the total flexibility to——

Senator MURRAY. I know you have said that before. And I appreciate that, but I would remind all of us that there are a number

of targeted funding streams in the President’s education reform

proposal, including Reading First, Technology, After School Programs, and Charter Schools. This is where the Administration has

said, ‘‘We do believe targeted funds make a difference.’’

I am passionately telling you I believe that there are other areas,

as well, including class size.

Secretary PAIGE. That I think has an important role to play. We

are talking about how broad or how narrow it is. And I thought

that the teacher class size reduction legislation, the previous legislation, was too narrow.

I thought that it was too restrictive. And I would have preferred,

as an administrator, the flexibility of using my judgment on the

scene, on determining how I could improve teacher quality. But the

broadness of the teacher quality is——

Senator MURRAY. We would disagree on that.

Secretary PAIGE [continuing]. What we are talking about. I think

that, clearly, you know that I agree with the—that smaller is better, given just that—if you just think of that. But it is not that narrow. It is much more complicated than that.

Senator MURRAY. Well, I disagree.

Secretary PAIGE. So, I am just arguing about the narrowness of

the legislation. I’m arguing for a broader teacher quality package

that will allow the people on the scene to make those decisions.

Senator MURRAY. Well, I agree. Teacher quality is important, too,

but so is class size.

And before I yield my time, I just want to ask you a question

about the chart that you have here, because you show that between

1984 and 2002, the increase in funding has gone up significantly

and the red line representing NAEP reading scores, age nine, has

been level.

But is it not true that since 1984, when we had a little over 39

million students, our public schools have grown to serve 47 million

students? And that chart is a little bit misleading, because we are

actually educating a lot more kids in our public schools than we
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were in 1984. And those demands on the school system are not considered in that chart.

Secretary PAIGE. Yes.

Senator MURRAY. I just wanted to make that clear.

Secretary PAIGE. You are correct. That is correct. What that says

is our challenge is broader, our task is more difficult, but the——

Senator MURRAY. Sure.

Secretary PAIGE [continuing]. But the scores are still flat.

Senator MURRAY. But you cannot say that we have increased

funding and test scores have stayed the same to make the correlation that individual students are getting more money, because we

are clearly educating more students in our schools.

I understand my time is up. And I would yield back to the Chair.

Secretary PAIGE. Yes.

Senator SPECTER. Thank you very much, Senator Murray. We

are sticking very close to the time. There is a Judiciary Committee

meeting. And I have just been informed that they have nine Senators and need a tenth for a quorum.

So, we are going to take Solomon’s approach and split the Senator down the center, so he can be in two places at one time.

Let me proceed to ask you a number of questions, Mr. Secretary,

and either to have abbreviated answers, so I can cover them rapidly, or you can put them in writing. And then I am going to defer

to Senator Harkin, who has one more question. And then I am

going to excuse myself.

VOUCHERS AND SCHOOL CHOICE

On the question of vouchers, the President’s program provides

that if certain standards are not met within a third-year point,

there will be vouchers issued.

As I understand it, in the past, you have opposed vouchers to private schools.

Secretary PAIGE. Well, no, I have not.

Senator SPECTER. That is not so?

Secretary PAIGE. I have been a passionate supporter of cooperating with private schools and had a very broad private school program in Houston I operated for 4 years.

Senator SPECTER. Well, there is considerable concern in the Congress about vouchers. As you know, they were defeated in the

House and——

Secretary PAIGE. I am aware of that.

Senator SPECTER [continuing]. My instinct is that while it will be

a close vote, it will probably not succeed. And I would like for you

to submit, in writing to the committee, because it is a complicated

subject——

Secretary PAIGE. Yes, it is.

Senator SPECTER [continuing]. And you cannot deal with it——

Secretary PAIGE. Right.

Senator SPECTER [continuing]. In a few minutes, your philosophical grounding. We have great respect for your views, because

of your experience. Also, please deal with the question which is

raised so consistently about what will happen to the public school

system if vouchers do become the order of the day. And also, to
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comment on the amendment to be offered by Senator Carper,

vouchers for use in public schools.

Secretary PAIGE. Yes, sir.

Senator SPECTER. The program of Youth Violence was adopted by

this subcommittee 2 years ago, really utilizing the same philosophy

that you have approached, and that is by taking $1.45 billion from

other programs and directing it to Youth Violence. And I would appreciate it if you would take a look at the program we have coordinated with the Department of Health, Human Services and Labor

and Department of Justice, and give us your evaluation of that.

It is my hope to have a meeting coordinated with the President’s

domestic advisor. We would be interested in your evaluation there,

and your further suggestions on how we deal with youth violence.

We have made this proposal without any news conferences, any

public attention, but with a whole series of workshops where Senator Harkin and I personally participated for hours on end, bringing in the people who really know—the technicians in the field.

And we would appreciate it if you would take a look at it——

Secretary PAIGE. I will.

Senator SPECTER [continuing]. And give us your advice.

CAMPUS CRIME

Next, there is the issue of campus crime, where legislation was

enacted more than a decade ago, after a brutal rape-murder at a

Pennsylvania college, and the parents, Mr. Howard and Mrs.

Connie Clery, came forward.

Now, there has been a problem with respect to the Department’s

implementation of the Clery Act. The guidance from the Department on reporting standards has been hard to get. And when there

are violations, it is difficult to secure investigation and corrective

action. I had introduced that legislation and later produced amendments to toughen it up.

And this is something which is very, very important; the essence

of which is to tell people what is happening on the campus, so they

know what the risks are. And that has the therapeutic effect of colleges and universities not wanting to report campus crime, so acting to prevent it and a great many efforts to circumvent it by not

counting the sidewalks through the university campus as part of

the university or not counting university leased premises as part

of the university.

So, we would appreciate your review and comment on that.

Secretary PAIGE. I thank you for that legislation, Mr. Chairman.

And I will tell you, you have my commitment that we are going to

have a strong look at this, because this is the right thing to do. You

have our support.

BUDGET INCREASES TO BE TIED TO REFORM AND RESULTS

Senator SPECTER. Well, I appreciate that comment. I only want

to ask you one question for the record. I wrote down what you said,

when you said, ‘‘I think that the President is ‘amenable to increasing the spending of funds.’’’

By that, do you mean that if the Congress comes in somewhat

higher or a little higher or reasonably higher than the President’s

budget, we might get him to sign the bill?
276

Secretary PAIGE. I meant by that, that the President appears to

me, from my interaction with him, willing to fund reform. And dollars that are tied to making things work better, he seems to be

more willing to support.

So, the connection would be funding reform. What he objects to

is funding failure.

Senator SPECTER. Well——

Secretary PAIGE. I think he would be willing to spend whatever

amount is necessary to reform the system, assuming those two

things are connected.

Senator SPECTER. Well, that is a fair challenge. If we tie our

spending to reform, we may then look for the President’s concurrence.

Mr. Secretary, thank you very much for coming in.

Secretary PAIGE. Thank you.

Senator SPECTER. Again, I think we have covered the subject

matter, although we have subverted on you to respond in writing,

because of limitations of time. And I am going to turn the gavel

over to Senator Harkin, who says he has one more subject matter.

It is that hot newspaper article that he is indifferent to that he

wants to ask you about.

Thank you, Mr. Secretary.

Secretary PAIGE. Thank you. And thank you, Mr. Chairman, for

your leadership.

Senator HARKIN. Thank you. I have actually got two questions,

but one basically that covers——

Senator SPECTER. You can answer only one of them. You take

your source. He said he only had one question.

Senator HARKIN. Then I will adjourn it, Mr. Chairman.

Senator SPECTER. Thank you.

Senator HARKIN [presiding]. Mr. Secretary, again, back to the

construction thing. Again, it is my understanding that your department has written a new guidance, alerting States that they might

be able to spend school renovation grants in a way that Congress

did not intend.

Under current law, 75 percent of this money had to be used for

school renovation; 25 percent could be, if they wanted to, used for

IDEA, Individual Disabilities—doing things that meet their needs

for special education and technology for special education.

I am understanding that your new guidance is telling the States

they do not have to do this, because Congress might eliminate the

fund. First of all, what is the status of this guidance?

Secretary PAIGE. Mr. Chairman, let me find out more about that.

I am not equipped to answer that question, but I promise this——

Senator HARKIN. Yes.

Secretary PAIGE [continuing]. Administration supports administering it so that congressional intent is carried out. So, I will look

into it and get right back to you on that one.

Senator HARKIN. I would like to know that, because I just heard

this, and I was just going to urge you to not issue this guidance,

because——

Mr. SKELLY. Well, Senator Harkin, we have not issued the guidance, yet. We have drafted it. And we shared the content of the
277

guidance with some of the staff on your committee just to see what

they would think about it.

PRESIDENT’S PROPOSAL AND USE OF SCHOOL CONSTRUCTION FUNDS

What it says is that although the current law does allow States

considerable flexibility in using money for IDEA or technology, in

addition to school renovation, the President’s budget has made a

proposal that would allow them even more flexibility to use that;

not just 25 percent, but maybe 50 or 100 percent for special education or technology, if they chose to do that.

It is a proposal that was in the President’s budget. The Congress

would have to accept that proposal, pass it, and the President

would have to sign it into law for that to take effect. And the guidance merely reiterates that the President’s budget made that proposal.

Senator HARKIN. I understand what you are saying is that you

would take the 2001 money, the money we already appropriated,

and change how they could spend it, but you cannot do that on

your own. You have to get us to do that.

Mr. SKELLY. That is exactly right. The guidance says——

Senator HARKIN. Well, I can tell you right now, forget it.

Mr. SKELLY. All right.

Senator HARKIN. Forget it. It is not going to happen. I cannot

speak for the Chairman, but I think I can on this one. Forget it.

Mr. SKELLY. Okay.

Senator HARKIN. Because what that would do, I think, would create a lot of turmoil out there. We will fight the other battles next

year and beyond, but on this one, I think it might confuse a lot of

school districts out there and say, ‘‘Well, we want to apply for the

money. Why apply for it, if we cannot use it and they are going to

change it?’’

As long as it is there, the money is—goes out July 1st. School

districts, I know, all over the country, are thinking about applying

for this. There are State Departments of Education. I do not think

it would be fair to confuse them on it at this point.

FUNDING FOR SPECIAL EDUCATION AND IDEA REAUTHORIZATION

But what I really wanted to ask—now I am going to run out of

time here—is that the administration indicated it was particularly

upset by a vote last week to increase funding for schooling disabled

students and lock it into the Federal budget for the next 10 years

by shielding it from the annual appropriations process, which is exactly what we did.

We put it on the mandatory side. It had broad-based bipartisan

support. Senator Hagel was my co-sponsor on it; Senator Jeffords,

Senator Specter. I mean, broad. It passed by unanimous consent

and no one objected to it. And officials described the proposal as

costly and unwarranted.

Can you please respond to that, because this is very, very disturbing?

Secretary PAIGE. Well, Senator, I have not read that. This is the

first time I have heard that language. I do not have anything to

add to what is written there, because I have not ever seen the article.
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Senator HARKIN. Okay. So, it did not come out of your shop,

then.

Secretary PAIGE. I do not know.

Mr. SKELLY. That is from the Statement of Administration Policy, which is issued by the Office of Management and Budget. It

was part of a longer piece. And it mentioned the IDEA amendment.

Senator HARKIN. Is that a correct quote, then, from it; that it is

costly and unwarranted?

Mr. SKELLY. Those are adjectives used in the statement, yes.

Senator HARKIN. By OMB. That meeting our 40 percent obligation was costly and unwarranted.

Mr. SKELLY. I think the argument is that the—making it mandatory at this time, as a floor amendment to the ESEA, without a

longer review of the IDEA—the IDEA, you know, was reauthorized

in 1997. It will come up again in another 18 months.

It would be good to have a more thorough review of the IDEA,

I think, is what the administration’s position is, rather than making a change now as part of a floor amendment on ESEA.

Senator HARKIN. Well, okay. I can accept that as an argument.

I just would point out that we are not changing any of the underlying law in IDEA. We are not—we are not changing it. We just

simply are appropriating money to meet the underlying 40 percent

requirement. That is all.

I do not—I cannot see any—any indication out there at all that

we want to reduce that 40 percent. I think that would run into a

firestorm around here.

Mr. SKELLY. I think there is one other change in the basic law

that would change the fiscal relief provision from 20 percent, which

was enacted in 1997, to 55 percent. In other words, of the additional funds that are made available for IDEA, Part B, State

grants, some of the—if States are providing services to children

with disabilities already, they could use some of that money for fiscal relief, use it for other purposes. So——

Senator HARKIN. But we can do that when we reauthorize IDEA.

What we did, putting it on the mandatory side, has no effect on

that. I mean, we can—we can do that. If that is the will of the Congress and the administration to do that, we can do that at that

time.

Mr. SKELLY. It was in—it was just in the same amendment.

Senator HARKIN. Well, I understand, but—but I do not—reauthorizing IDEA does not have anything to do with the funding. We

are just funding it. If we want to change the mix and stuff, we can

do that any time we want on the reauthorization end of it, 2 years

from now.

But I just think—the choice of words as being costly and unwarranted, I think, is a poor choice of words from OMB on that. And

I hope that there might be some clarification put out from the administration on this.

Mr. Secretary, do you have anything else to add before I——

Secretary PAIGE. I would just like to thank you for the opportunity to come and for the stimulating discussion about that. And

although we have some differences in point of view, I have great

respect for your interests in improving education in America.
279

TESTING AND ACCOUNTABILITY

Senator HARKIN. Well, we will work together on this. I know that

there are a lot of things we have got to do together. See, I want

to—just for the record, make it clear, I am not opposed to what you

are trying to do, in terms of testing and accountability and to try

to model what you did in the Houston school system. I have no

problem with that.

COST OF ANNUAL TESTING

I think there has got to be a broader approach and other things

that we have got to do beyond that. And fine. I can support your

proposals on that, but funding, I guess, maybe we look at it, as appropriators—the National State Boards of Education estimated

that all this additional testing would cost $2.7 to $7 billion extra.

Now, I cannot verify that. That is what I heard from the State

Boards of Education.

Well, if we are going to require them to test, we ought to help

them with some of the funding, too. I mean, I do not know if that

is a proper amount of money or not. But somehow we are going to

have to think about getting some additional funds out there for

helping them with this testing and stuff.

Secretary PAIGE. May I just make one observation about that,

Mr. Chairman? The President is proposing $320 million to help

States with the development of tests. The actual implementation of

tests, the cost of that varies with the effectiveness of the management of the various test implementors.

In Houston, it cost—we had to spend—for nine administered

grades, 1 through 11, we implemented that at the cost of about $10

per child. And that was because it was very finely managed and

carefully controlled. That cost could vary from what I think to be

our very effective cost of $10 per child to $50 a child. It would depend on the effectiveness of the organization and how much the

people who administer it want to save dollars there.

So, it is a figure that we really cannot get our arms around. And

besides, the 1994 reauthorization required administering tests to

all the students at least three times through the pipeline. And

there was no argument, then, about paying for those tests that

they imposed on school districts at that time.

So, what we are talking about is simply just adding tests, but we

do see a need to help with the development of these tests. We know

that this is going to be a process, not an event. And we will grow,

in terms of learning about the costs.

CLOSING REMARKS

Senator HARKIN. Fair enough. Well, thank you very much, Mr.

Secretary——

Secretary PAIGE. Thank you.

Senator HARKIN [continuing]. For your dedication to education. I

am sure we will have an opportunity to meet repeatedly, between

now and whenever we get our budget through and our appropriations bills through, to work out our problems on this.

Secretary PAIGE. Thank you, Senator.
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ADDITIONAL COMMITTEE QUESTIONS

Senator HARKIN. Thank you very much. There will be some additional questions which will be submitted for your response in the

record.

[The following questions were not asked at the hearing, but were

submitted to the Department for response subsequent to the hearing:]

QUESTIONS SUBMITTED BY SENATOR ARLEN SPECTER

PRIVATE SCHOOL VOUCHERS

Question. Please provide your philosophical grounding for your support of vouchers and explain what you think happens to the public school system. Also, please

provide your view of Senator Carper’s bill and its impact on the public school system.

Answer. In the broadest sense, we believe that just as market-based competition

works throughout our economy to maximize the efficient use of resources and provide high-quality goods and services at low cost, greater competition is good for our

system of public education. This is why, for example, the President is such a strong

supporter of charter schools, which encourage innovation that not only leads to better options for parents and students, but also brings pressure on regular public

schools to improve their own educational offerings.

We also support the limited use of vouchers because we believe that parents and

students alike benefit greatly from the ability to choose the school that best meets

their educational needs. And when parents choose the school their child attends,

they are more likely to actively support the school. I can tell you from personal experience that when parents get involved in our schools, good things happen.

More specifically, it cannot be denied that there are too many schools that are

failing our children, denying them the opportunity to reach their full potential as

citizens and human beings. Vouchers and other forms of choice can help ensure that

no child is trapped in a failing school—one of the central goals of No Child Left Behind.

As for the impact of vouchers on our public schools, I have two answers. One is

that for the foreseeable future the vast majority of our children will continue to attend public schools, even if in limited circumstances vouchers are available. In my

view, vouchers present very little in the way of a threat to our long tradition of public education. In large part this is because of my second answer, which is that in

general public schools compete very well with private schools. This was my experience in Houston, and I believe it would be the experience nationwide if voucher systems were more widely adopted.

AMENDMENT PROPOSED BY SENATOR THOMAS R. CARPER

Senator Carper’s proposed amendment would authorize competitive grants to

States or school districts to support the implementation of universal public school

choice programs. As you know, President Bush and I support the expansion of

choice and educational options for parents and students, and I believe Senator Carper’s proposal would be a step in the right direction in this area. In particular, the

Carper proposal would support the creation of meaningful choice by helping to pay

for the cost of transporting students to the schools they choose to attend, and by

helping to expand capacity at the high-quality, high-demand schools that students

will want to attend.

YOUTH VIOLENCE

Question. Please look at the programs included in the youth violence prevention

initiative that we have coordinated with other agencies and evaluate what has been

done and provide further suggestions on how to deal with the issue of youth violence.

Answer. A number of the programs included in this initiative are demonstrating

an impact on fostering youth violence prevention activities in communities across

the country. For example, the Safe Schools/Healthy Students initiative the Department of Education has funded jointly with the Departments of Justice and Health

and Human Services is supporting collaborations between schools, mental health

providers, and law enforcement that promote healthy child and youth development

and safer schools. In fiscal year 2000, some Safe Schools/Healthy Students commu-
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nities reported decreases in arrests and detentions for violent acts at school. They

also reported increases in the provision of mental health assessment and treatment

services to students.

The Department’s 21st Century Community Learning Centers program is helping

to provide safe and stimulating after-school environments for students in supervised

settings in which they can receive homework support, mentoring, drug and violence

prevention counseling, and college preparation services. One grantee has reported

a 40 percent drop in juvenile crime in the neighborhood surrounding the Learning

Center’s after-school program. Another has reported that the program led to a substantial drop in student use of drugs, alcohol, and tobacco.

Several States are reporting that their Character Education programs are having

a positive influence on student behavior. For example, an independent evaluation

of the first year of Maryland’s program found that students were perceived to be

more likely to solve conflicts without fighting, insults or threats; to respect others’

personal rights; and to treat classmates with respect. In Utah, participating schools

reported a decrease in discipline referrals, fewer student fights and confrontations,

decreased vandalism, less tardiness, and an increase in positive behaviors such as

interacting more kindly and respectfully with students and teachers, better attendance, improved achievement, and greater student involvement in extracurricular activities.

One of the strongest suggestions I can offer for addressing the problem of youth

violence is to hold schools accountable for school safety. That is why the Administration’s No Child Left Behind proposal would require States to develop a definition

for a ‘‘persistently dangerous school’’ and to provide victims of serious, schoolbased

crimes and students trapped in persistently dangerous schools the option to transfer

to a safe alternative.

CLERY ACT IMPLEMENTATION

Question. I have some concerns about the Department of Education’s implementation of the Clery Act. Please review and comment on the implementation of this Act.

Answer. The Department has made a good faith effort to implement the Clery Act.

Last year, for example, the Department collected crime statistics as required by the

Act. In collecting these statistics, the Department used a web-based data collection

tool through which statistics were publicly available as the data were collected. This

approach—combined with the Department’s aggressive enforcement of the requirement—resulted in a 100 percent response rate to this data collection.

In addition to collecting the campus crime statistics, the Department has successfully investigated allegations that institutions were misrepresenting their crime statistics. Generally, we have been successful in bringing institutions into compliance

with the requirements of the Act. When appropriate, the Department has imposed

fines for non-compliance.

EDUCATION FUNDS FOR REFORM

Question. You stated during your oral remarks that you believe the President

would be ‘‘amenable to increased funding.’’ Please elaborate on this remark.

Answer. As I said earlier, the question is really not about funding, but reform.

I believe the President is willing to fund serious reform efforts, such as those proposed in No Child Left Behind and included in our 2002 budget request. He is not

willing to continue funding failure in our education system.

SCHOOL RENOVATION GRANTS—GUIDANCE FOR IMPLEMENTATION

Question. What is the status of the Department’s guidance for implementation of

the School Renovation grants program enacted in the fiscal year 2001 Labor-HHS

Education appropriations conference report?

Answer. The Department distributed guidance for the School Renovation grants

program to State coordinators on May 17, 2001.

Question. What statutes, rules or regulations (internal Department or government-wide) govern when and how the guidance may be issued?

Answer. The School Renovation program guidance is non-regulatory. Nonregulatory guidance is not subject to the Administrative Procedures Act, as is the case

with regulations. Furthermore, other statutes or regulations do not generally govern

the issuance of guidance.

The guidance for the school renovation program is designed to explain, using plain

language, the provisions of the legislation to help grant recipients understand the

requirements in the legislation. The Department conducts an internal review of

guidance to ensure consistency with legislation before it is issued.
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Question. Will the guidance package be wholly consistent with congressional intent as expressed in the fiscal year 2001 Act, and will the purpose of the program

be reflected throughout the document (including cover notes, supplemental material,

guidance, etc.)?

Answer. Yes, the guidance package is wholly consistent with the congressional intent expressed in the Fiscal Year 2001 Department of Education Appropriations Act.

As you know, the Administration’s 2002 budget submission proposed to amend the

2001 appropriations act to provide States with additional flexibility in how they may

spend their portion of the $1.2 billion in fiscal year 2001 school renovation funds.

The Administration proposes to allow States to choose how much of the funds may

be spent on any of the three currently allowable activities: school renovation, activities under Part B of the IDEA, and technology activities associated with school renovation.

If Congress enacted the Administration’s proposal, we would communicate the enactment to the States. The Administration remains committed to securing this flexibility for the States whether congressional action occurs before or after July 1 of

this year.

21ST CENTURY COMMUNITY LEARNING CENTERS

Question. The budget request proposes to consolidate the 21st Century Community Learning Centers and Safe and Drug-Free Schools programs in a formula driven State grant program so that school districts can support drug and violence prevention activities as well as after school activities. How will this help improve student safety given the findings in the Department’s ‘‘Progress in Prevention’’ national

evaluation of the Safe and Drug Free Schools program that 46 percent of districts

would lose their prevention programming without its funding and more than 75 percent would reduce them to a great extent?

Answer. The Administration’s fiscal year 2002 budget request does not propose to

consolidate the 21st Century Community Learning Centers and Safe and Drug-Free

Schools programs into a single formula grant program. The request would maintain

separate funding streams for the two programs.

The Administration is requesting $644 million in fiscal year 2002, the same as

2001, for the Safe and Drug-Free Schools program. However, a greater proportion

of total funds would flow to States under the President’s proposal (as compared to

the 2001 funding level for State Grants) to help ensure that children receive a highquality education in a safe and drug-free environment. The President’s No Child

Left Behind proposal for reform of elementary and secondary education would hold

States accountable for school safety by requiring States, as a condition of receiving

a performance-based grant for safe and drug-free schools, to: (1) develop a definition

for a ‘‘persistently dangerous school’’ and to report on school safety on a school-byschool basis; (2) provide victims of serious, school-based crimes and students trapped

in persistently dangerous schools the option to transfer to a safe alternative; and

(3) adopt a ‘‘zero-tolerance’’ policy that empowers teachers to remove violent or persistently disruptive students from the classroom.

The Administration is also requesting $845.6 million, the same as fiscal year

2001, for the 21st Century Community Learning Centers program. Program funds

would be used to provide students, particularly students who attend high-poverty

or low performing schools, with high-quality extended learning opportunities to help

them meet challenging academic standards.

UNMET NEED AND ACCESS TO HIGHER EDUCATION

Question. ‘‘Access Denied’’, a report of the Advisory Committee on Student Financial Assistance was released in February 2001 and identified three interrelated factors that conspired to produce what is fast becoming an access crisis. The first is

the increasing cost of higher education as a relative percentage of family income

only for low-income families and the shifting focus of Federal, State, and institutional policies toward merit-based programs. Second, is the steep rise in unmet need

of low-income students. On average, the very lowest income students face $3,200 of

unmet need at 2-year public institutions and $3,800 at 4-year public institutions,

even after factoring in loans. Third, students, motivated by rational financial considerations, make choices that lower the probability of their persistence and degree

completion significantly. In addition, dramatic demographic changes will produce an

increase in college enrollment of 18 to 24 year olds of 1.6 million by 2015.

Last year’s final appropriation included resources to increase the maximum Pell

Grant by $450. How does this budget reduce the opportunity barrier of unmet need

and increase access to postsecondary education for low-income students?
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Answer. The fiscal year 2002 President’s Budget includes a three-pronged approach to enhancing access to postsecondary education among low-income students,

which provides: (1) $1 billion in additional Pell Grant funding, increasing the maximum grant to a record $3,850 (under this proposal, the maximum grant will have

grown by nearly 43 percent over the five years through 2002, significantly faster

than tuition and fee increases over the same period); (2) continued support for supplemental grant assistance under the TRIO Student Support Services program, as

well as increased funding for TRIO academic support and counseling services to lowincome students to better prepare them for higher education; and, (3) additional

funds to strengthen institutions that serve large numbers of minority and low-income students, including Historically Black Colleges and Universities and Historically Black Graduate Schools, and for Hispanic Serving Institutions.

PERSISTENCE IN COLLEGE

Question. What does this budget propose to increase persistence for students saddled with high levels of debt and significant work responsibilities while attending

school on a full- or part-time basis?

Answer. Research on the relationship between persistence and work and persistence and debt on several occasions has yielded mixed results. Many analysts believe

that the decision to depart from postsecondary education is related to a student’s

specific short- and long-term plans, the strength of the student’s desire to finish,

and the difficulties associated with adapting to the challenges of college life. In this

area, the Department’s budget includes increased assistance to institutions of higher

education that serve large populations of low-income and minority students to help

them meet the needs of their students, as well as to programs that directly respond

to the needs of low-income and first-generation college students. For example, the

budget includes additional support for Historically Black Colleges and Universities

(HBCUs) under Title III and Hispanic-Serving Institutions (HSIs) under Title V to

help these institutions meet the growing demand for their services. The budget also

includes an increase for the TRIO programs, which help to prepare low-income students for college and help improve retention and success rates among these students

once they enter college.

GROWTH IN COLLEGE POPULATION

Question. How is the Administration planning to support the increasingly diverse

needs of the additional 1.6 million college students expected by 2015?

Answer. The fiscal year 2002 budget proposal addresses the short-term needs for

funding for postsecondary education. The Administration’s long-term strategy for

supporting the diverse needs of students enrolled in postsecondary education will be

developed as we prepare for the reauthorization of the Higher Education Act in

2003.

QUESTION SUBMITTED BY SENATOR LARRY E. CRAIG

TRIO PROGRAMS

Question. Mr. Secretary, in my State, I know that TRIO’s Upward Bound and Talent Search programs have been very successful in serving middle and high school

students. These programs are enabling students attending under-performing schools

to raise their aspirations and develop the skills to achieve those goals. How are you

including TRIO in your Department’s overall plan to meet the educational needs of

all children?

Answer. TRIO plays an important role in our overall plan by ensuring that the

needs of students are met all the way through college. In particular, the Upward

Bound and Talent Search programs target disadvantaged middle and high school

students, providing tutoring, mentoring, counseling, and other services to adequately prepare them for success in college. The Student Support Services program

provides similar services once these students are in college, helping them to achieve

their higher education goals. The $50 million increase requested for the TRIO programs would significantly expand these services and increase the number of students who would benefit.
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QUESTIONS SUBMITTED BY SENATOR TOM HARKIN

ACCESS TO A COLLEGE EDUCATION

Question. The President’s budget would increase the maximum award for Pell Grants by just $100, to $3,850. That’s $355 less, in real dollars, than 25 years ago.

In the meantime, college tuition costs have skyrocketed. If we really want to leave

no child behind, shouldn’t we do more to help our poorest high school graduates get

a college education?

Answer. To help the poorest students and families pay the rising cost of attending college, the Administration is proposing an additional $1 billion in Pell Grants to

increase the Pell Grant maximum award to $3,850, the highest award ever. Under

this proposal, the maximum grant will have grown by nearly 43 percent over the

five years through 2002, significantly faster than tuition and fee increases over the

same period. The Pell Grant program is the foundation of the Federal student assistance effort and is designed to help low- and middle-income students attend college.

Helping the poorest high school graduates get a college education requires more

than just providing financial assistance, however, since a disproportionate number

of low-income and minority students who do enter college do so without the academic preparation needed for success. The Administration’s budget would increase

support for the Federal TRIO programs to help prepare low-income and minority

students for postsecondary education. In addition, the Administration is proposing

to increase assistance to institutions of higher education that serve large populations of low-income and minority students to help them meet the needs of these

students.

ELEMENTARY SCHOOL COUNSELING DEMONSTRATION PROGRAM

Question. Most people agree that school mental health and prevention services are

critical to creating a healthy and safe learning environment. But the President’s

budget would eliminate $30 million for the Elementary School Counseling Demonstration Program, which provides assistance for hiring school counselors, school

social workers, and school psychologists. Why does the President oppose this program?

Answer. Neither the President nor I oppose the provision of counseling and mental health services for students; we just oppose the proliferation of small, categorical

Federal programs with narrow purposes that limit State and local flexibility to address State and local needs. Under the President’s 2002 budget request, funding for

the Elementary School Counseling Demonstration program is consolidated under

the $471.5 million proposed Choice and Innovation State Grants program. School

districts would be permitted to use funds under this flexible grant program to hire

school counselors, social workers, and psychologists if they choose. School districts

may also use their Safe and Drug-Free Schools and Communities State (SDFSC)

Grant funds to provide counseling and related services for students. The President’s

2002 budget request includes $547.3 million for SDFSC State Grants, a $108 million

increase over 2001.

SPECIAL EDUCATION TEACHER SHORTAGES

Question. There is a tremendous shortage of special education personnel throughout the country—second only to math/science. Currently there are over 35,000 individuals teaching students with disabilities who are not qualified to do so. The Department of Labor estimates that schools will need more than 200,000 new special

education teachers over the next five years. Yet our colleges and universities prepare only half that number. We are even beginning to document increasing shortages of special education faculty in our Nation’s universities.

In addition, with new programs, such as the President’s Reading First and Early

Reading First, there will be even a greater need for special education professionals

with skills in communications disorders and early literacy interventions. The President’s budget calls for level funding for Personnel Preparation for the Individuals

with Disabilities Education Act (IDEA). This account has not received an increase

in over a decade despite these critical shortages. We are working hard to fully fund

Part B of IDEA, but without qualified teachers, we will not get the results we want.

What is your plan to address these critical personnel shortages, and why didn’t you

request an increase in funding for Personnel Preparation?

Answer. We believe that if large increases in funding are provided over a short

period of time for the Grants to States program under Part B of IDEA, they may

not be used to achieve the improved results we all want for children with disabilities. For example, with large increases local educational agencies may have more
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resources to hire special education teachers, but may be unable to do so because the

supply of such teachers is relatively inelastic in the short term. However, more gradual increases, such as the $1 billion increase proposed in the

President’s budget, may be used effectively to promote improved working conditions,

smaller class sizes, retention incentives, inservice training, and other activities as

well as increased salaries that will create greater incentives for college students to

enter and remain in the field of special education. We believe that the best way to

recruit and retain special education personnel is through enhancing the value of

working in that field and not necessarily through providing additional funds to institutions of higher education, which is the primary activity under the Special Education Personnel Preparation program.

In addition to the funds requested for the Grants to States program, funds to address personnel needs are also provided through the Special Education State Improvement program, which was authorized by the IDEA Amendments of 1997. This

program awards grants to States to help them to address their particular needs.

States must use at least 75 percent of their grants under this program to address

their special education personnel needs. Our fiscal year 2002 request for this program is $49.2 million, and there was a $14 million increase in funding for the program in fiscal year 2001.

We believe that the combination of increased funding provided for the Grants to

States program, support for the new State Improvement program, and maintenance

of support for the Personnel Preparation program will begin to effectively address

our needs for special education personnel.

MATH AND SCIENCE BUDGET SUPPORT

Question. The President’s budget calls for tripling the spending on reading to improve instruction and student achievement in the early grades. His education reform

plan would require annual testing in reading and mathematics. Given that teacher

shortages put math and science at the top of the list, why is a similar investment

in the preparation and professional development of teachers in those key fields not

similarly recommended in the budget for the Department of Education?

Answer. No Child Left Behind reflects the President’s commitment to improving

the quality of our teaching force in all subject areas, including mathematics and

science, because teacher excellence is vital to achieving improvement in student

achievement. The Administration’s fiscal year 2002 budget request reflects this commitment because it includes $2.6 billion for the Department of Education for the

State Grants for Improving Teacher Quality program and $200 million for the National Science Foundation for the Math-Science Partnership program.

The State Grants for Improving Teacher Quality program would combine funding

from several existing education programs, including Class Size Reduction and Eisenhower Professional Development State Grants, into performance-based grants

that provide sufficient flexibility for States and local educational agencies (LEAs) to

meet their particular needs and to strengthen the skills and improve the knowledge

of teachers and administrators. Because of the flexibility that the President is proposing for this program, States and LEAs would be able to use program funds to

improve the quality of their mathematics and science teaching force, if they believe

that would best address their needs.

In return for this flexibility, States and LEAs would be required to ensure that

program funds are used for professional development that is grounded in scientifically based research. States would be held accountable for ensuring that all children are taught by effective teachers and improving student academic achievement.

Professional development programs also would be tied to State or local standards,

of sufficient intensity and duration to affect teaching performance, and directly related to the subjects taught by the teachers who are participating in the professional

development.

In addition, the Math-Science Partnership program, which the President is proposing as a National Science Foundation program, would provide funds for States

to join with institutions of higher education to strengthen mathematics and science

K–12 education. These partnerships, which could also include LEAs, would provide

highquality teacher preparation and professional development for mathematics and

science teachers, help to implement high standards in mathematics and science education, and address gaps between the education of advantaged and disadvantaged

students.

ASSISTIVE TECHNOLOGY ACT, TITLE I STATE GRANTS PROGRAM

Question. The State Grants program under Title I of the Assistive Technology Act

is slated to sunset beginning this year. And the President’s budget calls for an in-
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crease of $25 million for the Title III Assistive Technology Loan program. To date,

all of the grants that have been awarded under Title III have been awarded to the

Title I State projects. Who will run these loan programs if the Title I projects sunset?

Answer. Under Title III of the Assistive Technology (AT) Act, the Secretary is authorized to make grants to States for the administration of alternative financing

programs. In order for a State to be eligible for funding under the Title III Alternative Financing Program, the State must receive or have received Title I funding.

Therefore, the AT Act clearly contemplates that when States apply for Title III

funds they may no longer be participating in the Title I program. In addition, the

State is required to enter into a contract with an experienced community-based organization to administer the Alternative Financing Program.

GAANN AND JAVITS FELLOWSHIPS

Question. The Department proposes level funding of the Graduate Assistance in

Areas of National Need (GAANN) and Jacob Javits program at $31 million and $10

million, respectively. These programs support graduate students who will become

the teachers, scholars and researchers of tomorrow. Since the stipend level for these

two programs is tied by statute to the stipend level for the Graduate Research Fellowship program at the National Science Foundation (NSF), the stipend for both

these programs will increase to $18,000 per student in the 2001–2002 academic year

and to $20,500 in 2002–2003. Because of this, the number of new fellowships in the

Javits program will decrease significantly and there will be no resources available

for a GAANN competition or new awards this coming year. Knowing that an increase in funding, to keep pace with statutory obligations to increase stipends, was

the only way program integrity could remain intact, why did the Administration decide to level-fund both programs?

Answer. At the time we submitted our fiscal year 2002 budget request, the approved NSF stipend level was $18,000. Unfortunately, we had no way of knowing

that it would be increased for the second time in two years to $20,500 for the 2002–

2003 academic year. However, knowing that it is difficult to predict the average fellow’s level of need and the maximum stipend level that will be in effect at the time

we make awards, our estimates were based on all fellows receiving the maximum

stipend that was in effect at the time we submitted the budget. As such, our estimates reflect the minimum number of fellows that would have been supported with

a maximum stipend of $18,000.

Under the Administration’s request for the Javits Fellowships program, even with

a stipend level of $20,500, a minimum of 60 new fellows would be supported in fiscal

year 2002. The request for GAANN, even though it would not support a new competition, would maintain support for approximately 1,070 continuing fellows. A new

competition would be held again in fiscal year 2003.

Question. What will the Administration do in the future to support these two

small, yet vitally important programs in graduate education?

Answer. The Administration will continue to work to ensure that all low-income

students have the resources necessary to complete their postsecondary education.

The Javits Fellowships and GAANN programs play an important role in preparing

students for scholarly careers and careers in areas of national need, which will remain a critical part of our goal to strengthen America’s workforce.

VOCATIONAL EDUCATION PROGRAMS SUPPORT

Question. Career technical education funding has declined 19 percent, in real dollars, in the past decade. At a time when the Labor Department is reporting increasing unemployment, why has President Bush level funded and, in some cases, cut

programs in the Carl D. Perkins Vocational Technical Education Act, a law whose

sole purpose is to prepare America’s students with the skills, education and training

they will need to pursue employment or higher education? Please address the proposed level funding of Basic State Grants, the cut to National Programs, and the

elimination of the Tech Prep Demonstration Program.

Answer. The Department’s 2002 budget received the largest percentage increase

of any Cabinet-level domestic agency. The budget reflects major increases for the

Administration’s highest priority areas, including $1 billion for Special Education

Grants to States, $1 billion for Pell Grants, and substantial new funding to implement changes proposed in No Child Left Behind, the President’s framework for reauthorization of the Elementary and Secondary Education Act. Under the proposal,

many programs are eliminated or consolidated, but none of the consolidations affect

the Vocational Education appropriation. The Administration recognizes the impor-
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tance of the Vocational Education State Grants by maintaining level funding for the

program. The fiscal year 2002 request includes $12 million for National Programs, a reduc- tion of $5.5 million. In past years, National Programs provided funds to assist in

the implementation of new accountability requirements and other provisions of the

1998 reauthorization. Now the implementation is well underway, and many national

activities have been, or will be, completed by fiscal year 2002. The request provides

sufficient funding to support major national initiatives.

The Administration requests zero funding for the Tech-Prep demonstration program, which is consistent with the effort to redirect resources to high-priority areas

and to eliminate small programs whose activities can be funded from other sources.

Currently, States can use funds they receive from the Tech-Prep State grant program to support this kind of activity. In fact, some States are already developing

and implementing Tech-Prep programs that locate secondary schools on community

college campuses and that can be disseminated and adopted by other States. The

Department does not believe that a separate, more prescriptively structured, program that specifically focuses on this area is needed.

QUESTION SUBMITTED BY SENATOR HARRY REID

ADDRESSING THE DROPOUT PROBLEM

Question. Secretary Paige, how do you plan to address the dropout problem our

nation faces? Please provide the specific, measurable steps you plan to implement

to address the problem.

Answer. Research has shown that poor academic performance is the best predictor

of who will drop out of school. Students who receive low grades, perform poorly on

tests, are retained in grade, or are absent frequently are more likely to drop out

before completing high school than are their peers. No Child Left Behind, the President’s framework for reforming elementary and secondary education, would apply

proven strategies—high State standards, annual testing of students in grades three

through eight in at least reading and mathematics, increased accountability for student performance, reduced bureaucracy and greater flexibility for States, school districts, and schools, and expanded options for parents to make choices for their children’s education—to strengthen Federal support for State and local efforts to help

improve student achievement.

The most effective strategy for preventing students from dropping out is to ensure

that they are successful and engaged at school. The strategies proposed by the

President would help ensure that all students have the opportunity to succeed in

school. For example, research has shown that early intervention for students who

show signs of academic difficulty or disengagement from school is very important.

The President’s proposal for annual testing of students in at least reading and

mathematics would provide teachers with current information on a child’s progress

in school, including specific strengths and weaknesses, and enable teachers to arrange for the types of support and remediation that are most likely to help that

child succeed academically.

In addition, research shows that students who fail to read well by the fourth

grade have a greater likelihood of dropping out and a lifetime of diminished success.

The Administration’s proposed Reading First State Grants and Early Reading First

programs will help States and school districts implement comprehensive reading instruction, grounded in scientifically based reading research, to enhance the prereading skills and school readiness of school-aged children and to ensure that all

children can read well by the end of third grade.

QUESTIONS SUBMITTED BY SENATOR MARY LANDRIEU

TITLE I BUDGET REQUEST

Question. Like you, I strongly believe that the targeted investments we make

through Title I Grants are key if we hope to turn around low performing schools,

improve teacher quality and ensure that all students achieve high standards. Although I am extremely pleased by the fact that all of the excess dollars included

under this section are to be allocated through the targeted grants formula, I still

have grave concerns about how little the President’s budget invests in increasing

Title I.

In my own State of Louisiana last year, their overall Title I allocation was reduced by $16 million because of insufficient funds at the Federal level. This year’s
288

increase, even if targeted, would bring only $2 million in new money for these purposes. This is in a State where over 20 percent of the school age kids are in poverty.

As a Superintendent, you know accountability and reform cost money. Do you honestly believe that this amount is sufficient to help achieve the goals the President

has laid out?

Answer. I agree that resources are important, but my experience as Superintendent showed that how money is spent can be just as important as how much

is available, and that improving management and accountability allow more funds

to be used for the instruction of students. In any case, the President’s budget does

include $400 million, an increase of $175 million or 78 percent, to support State and

local efforts to turn around low-performing Title I schools. Your State of Louisiana

will share in these funds in proportion to its overall Title I allocation.

I must point out, however, that Louisiana received a lower Title I allocation last year not because of insufficient funding—the Title I appropriation rose $660 million

or more than 8 percent from 2000 to 2001—but because its child poverty rate has

been declining in recent years. It is certainly true that Louisiana remains a poor

State, but according to Census estimates its percentage of school-age kids in poverty

fell from almost 29 percent in 1995 to a little over 24 percent in 1997. Other States

experienced growing poverty rates over the same period. The Title I funding formulas are designed to target funds to States and school districts that have a growing population of poor children, so this shift in poverty rates resulted in lower allocations for Louisiana and other States with declining relative shares of poor children, and higher allocations for States with rising proportions of poor children.

TRANSITION TO TEACHING

Question. I am glad to see that the budget includes additional resources to address the teacher shortage. I am particularly interested in two of the programs you

include. First, the Transition to Teaching program. Currently, this money is used

to support the Troops to Teachers Program, which is a wonderful program. I understand that this budget gives you the authority to expand on that program to recruit

other mid-career professionals. Can you tell me what efforts you hope to include?

Answer. For fiscal year 2002, the President is requesting $30 million for a Transition to Teaching initiative. In addition to funding the Troops to Teachers program

under this initiative, the Secretary would have the authority to reserve some of

these funds for a program that would be similar to the Transition to Teaching program for which Congress appropriated $31 million in fiscal year 2001. Funds could

support efforts to recruit, prepare, and support a wide range of talented careerchanging professionals as teachers, particularly in high-poverty schools and in highneed subject areas.

In fiscal year 2001, the appropriation for the Eisenhower National Activities program included $3 million to be transferred to the Department of Defense for the

Troops to Teachers program and $31 million for Transition to Teaching activities

to recruit and support mid-career professionals and recent college graduates to become teachers.

The Department has already transferred the $3 million in fiscal year 2001 funds

to the Department of Defense for the Troops to Teachers program. With these funds,

the Department of Defense will be able to support and expand the highly effective

Troops to Teachers program by providing high-quality teachers for more students

in high-poverty schools.

Also, the Department’s competition for the fiscal year 2001 Transition to Teaching

program is underway; applications became available in April and must be returned

to the Department by June 15, 2001. The fiscal year 2001 Transition to Teaching

program will provide support for recent college graduates with outstanding academic records to become licensed and successful teachers. The program would also

provide assistance for mid-career professionals with work experience in high-need

areas to become successful teachers.

TEACHER RETENTION AND RECRUITMENT GRANTS

Question. I am also concerned by your decision not to increase your efforts in the

area of higher education for teachers. In my own State, it has been the institutions

of higher education that have led the efforts to recruit and retain qualified teachers.

They also are crucial in preparing teachers for the challenges they will face. The

budget mentions that Title II Teacher Quality money is also available for these efforts, but that money is barely enough for professional development, recruitment

and retention of existing teachers. Would you care to comment?

Answer. The Administration’s budget includes $2.6 billion to support a new program, State Grants for Improving Teacher Quality, which is an increase of $375 mil-
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lion over funding provided in fiscal year 2001 for consolidating programs like the

Class Size Reduction and Eisenhower Professional Development State Grants.

Under the President’s proposal, States may choose to use these performance-based

grants for the kinds of activities authorized under the Title II program, including

changes to teacher certification or licensure requirements, alternative certification,

tenure reform, pre-service teacher preparation, professional development, and recruitment and retention initiatives.

PELL GRANT PROGRAM COSTS

Question. In the area of higher education, this budget includes an additional $1 billion to increase the Pell Grants by $100 to a maximum of $3,850. Recent program

data show that more students are applying for Pell Grants, and more of those applying are eligible for these awards, than was previously expected. Will some of this

money be used to address that issue as well, and, if so, how much of the billion will

be left for the increases in awards?

Answer. As you note, recent program data indicate that more students are applying for Pell Grants, and more of those applying are eligible to receive aid, than was

previously forecast. This has increased the cost of funding awards for the 2001–2002

award year by $117 million; this additional prior-year need would be funded from

the proposed $1 billion increase. In addition, the fiscal year 2001 appropriation used

$319 million in surplus funds from prior years to fully fund the maximum award

level of $3,750. In the absence of these supplemental and surplus funds, $436 million of the proposed $1 billion increase for fiscal year 2002 is needed to maintain

the previous year’s funding level, replacing the $117 million and $319 million used

in fiscal year 2001. An additional $78 million is needed to fully fund a $3,750 maximum award in fiscal year 2002. Increasing the maximum award by $100, to $3,850,

for academic year 2002–2003 requires $312 million, with the remaining $57 million

of the proposed $1 billion set aside to account for possible further growth in program

costs.

TRIO PROGRAMS

Question. Mr. Secretary, there are almost 9.6 million low-income students (from

middle school to college) currently eligible for the TRIO programs. In the next decade, demographic trends show that this number will grow considerably as more lowincome students move through the education pipeline.

Although TRIO has a demonstrated record of success, the current funding level

only allows approximately 6 percent of the eligible population to be served. Understanding the importance of these programs, many members on both sides of the

aisle have voiced their support of expanding TRIO so it can serve 10 percent of

those eligible. Is this a goal you think the Administration will support?

Answer. The Administration does support an expansion of the Federal TRIO Programs. In fact, our fiscal year 2002 budget request would expand TRIO to serve

785,000 low-income students, approximately 8 percent of the eligible population you

mention. The $50 million increase requested for TRIO would support more than 40

new projects and provide a greater intensity of services, high school work-study opportunities, and college scholarships to thousands of additional students. However,

TRIO is just one of many programs in the Administration’s ‘‘No Child Left Behind’’

proposal that reach out to low-income and minority students.

Under our budget request, Gaining Early Awareness and Readiness for Undergraduate Programs would provide academic and support services and scholarships

to more than 1 million students in high-poverty middle and high schools. Additionally, substantial increases would be provided for Historically Black Colleges and

Universities and Hispanic-serving Institutions that serve thousands of minority and

low-income college students. The President’s budget also includes an increase of $1.9

billion for the Department’s elementary and secondary education programs.

QUESTIONS SUBMITTED BY SENATOR ROBERT C. BYRD

AMERICAN HISTORY INSTRUCTION SUPPORT

Question. President Bush has stated that he wishes to strengthen and reform education, and he has presented Congress and the American people with an education

proposal that calls for renewed diligence in math, science, and reading. History education, however, is ignored. History, and specifically, American history, have become

stealth subjects, transformed and disguised under the labels ‘‘Social Studies’’ or

‘‘Civics,’’ or disregarded. Consequently, our children’s knowledge of American history

is shameful. What do you intend to do to address this question?
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Answer. The 2002 budget request for education, in tandem with the education reform proposals contained in No Child Left Behind, supports the President’s comprehensive vision for closing the achievement gap and improving the quality of education for all children. It is clear that Federal education policy is not accomplishing

its goals, despite the investment of more than $130 billion and the creation of hundreds of categorical programs over the past three decades. The President proposes

to eliminate many categorical programs to give States and communities greater

flexibility to use Federal resources for their own priorities. While the Administration’s proposals do not include a separate Federal program to improve history instruction, American history is clearly an important part of the overall curriculum.

We believe that States and school districts are in the best position to determine how

best to improve history instruction, and our proposals provide them with the flexibility to accomplish this improvement.

TEACHING AMERICAN HISTORY GRANT PROGRAM

Question. On a related subject, Congress appropriated $50 million in fiscal year

2001 to create the Teaching American History Grant program, a national program

intended to help put the study of U.S. history back into the classroom. Apparently,

however, the Administration intends to save millions of dollars in your Department’s budget by discontinuing all one-time projects, including the Teaching American History Grant program. Is it true that the Administration intends to eliminate

this program despite our education system’s glaring failure to teach the history of

our Nation?

Answer. The Administration’s budget request supports No Child Left Behind, the

President’s framework for reform of elementary and secondary education which proposes to eliminate or consolidate many categorical programs to give States and localities greater flexibility to use Federal resources for their own priorities. As you are

aware, the Department is proceeding to use the $50 million Congress appropriated

in 2001 to make awards under the Teaching American History grant program. Department staff have worked with your office, the National Endowment for the Humanities, and a variety of organizations dedicated to improving the teaching of

American history in order to ensure that this program is successful.

So that grantees have sufficient time and resources to implement high-quality

projects, the Teaching American History Grant program will make awards for up

to three years from the 2001 appropriation. Grants will support programs to raise

student achievement by improving teachers’ knowledge, understanding, and appreciation of American history. They will assist local educational agencies, in partnership with entities that have extensive content expertise, to develop, document,

evaluate and disseminate innovative, cohesive models of professional development.

These grants will offer models that can be adopted by other communities to help

improve the teaching of American history in U.S. schools.

As noted in response to the previous question, the budget does not include funding

to continue a separate American history program, but States and school districts

would have the flexibility to use other Federal funds to continue this type of activity.

CLASS-SIZE REDUCTION FUNDING

Question. The President proposed consolidating the Eisenhower Professional Development program and the Class Size Reduction program into a new teacher quality title under the Elementary and Secondary Education Act. Accordingly, his budget provides $2.6 billion for this new title. This would be a $375 million increase over

the combined fiscal year 2001 funding level of these programs. The Class Size Reduction program, which has been working to reduce kindergarten through thirdgrade classes nationwide from 25 to 18 students, supports the salaries of 37,000

highly qualified new teachers. If we are to stay on this program’s schedule to hire

an additional 13,000 new teachers in fiscal year 2002, while also fulfilling our obligation to pay the salaries of the 37,000 teachers already hired via this program, we

must provide additional funding for this program alone in the amount of $700 million. This is a shortfall of $325 million. At what level does the President intend to

meet the funding requirements of the Class Size Reduction program?

Answer. The fiscal year 2002 budget supports the Administration’s proposal, to

combine the Class Size Reduction program with the Eisenhower Professional Development State Grants program and a few other programs into a single, flexible State

grant program that supports State and local efforts to improve the quality of instruction. States and districts would use their funds for such activities as high-quality professional development, reforming teacher certification or licensure requirements, and alternative certification of teachers and administrators. In addition, a
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district that believes that reducing class size would be the most effective strategy

for improving student achievement within the district would be free to use its funds

to hire teachers to reduce class size, but no district would be compelled to use their

Federal funds in a manner that is not appropriate for its students and teachers.

This proposal is one of several consolidation proposals in No Child Left Behind,

the President’s framework for reform of elementary and secondary education. The

President believes that schools will work best when administrators, teachers, parents, and other interested parties, are given the latitude and support to implement

the educational reforms that best meet their needs, and then are held accountable

for producing results. The Administration recognizes that the same strategy is not

appropriate for all communities, and that is why we are proposing to give States

and districts greater flexibility in using their Federal resources.

Question. Does the President intend to fulfill the obligation of this program to hire

13,000 new teachers and to support the salaries of the 37,000 teachers previously

hired via this program, or does he intend to place the burdens of these teachers’

salaries on the local school districts, therefore, jeopardizing their continued employment and the Federal, State, and local efforts to reduce class sizes in grades K–3

to reasonable levels?

Answer. The Administration believes that every child in America deserves to be

taught by a high-quality teacher. The $2.6 billion requested by the Administration

in fiscal year 2002 for the State Grants for Improving Teacher Quality program is

sufficient to enable districts to retain the teachers that were hired previously under

the Class Size Reduction program and hire additional teachers to reduce class size

if a district believes that reducing class size would be the most effective strategy

for improving student achievement.

As I stated earlier, the Administration believes that schools will work best when

administrators, teachers, parents, and other interested parties, are given the latitude and support to implement the educational reforms that best meet their needs,

and then are held accountable for producing results. Under the Administration’s

proposal for the State Grants for Improving Teacher Quality program, Federal funds

would be available to support the research-based strategy for improving the quality

of instruction and student achievement that best meets the needs of the district.

However, no district would be compelled to use its Federal funds in a manner that

is not appropriate for its students and teachers.

QUESTIONS SUBMITTED BY SENATOR DIANNE FEINSTEIN

TITLE I ‘‘SHORTFALL’’

Question. The U.S. Department of Education has concluded that the fiscal year

2001 appropriations for Title I may fall short by about $165 million, and that States’

allocations will have to be reduced as a result. Do you support a supplemental fiscal

year 2001 appropriations bill to cover the shortfall?

Answer. The Administration completed a budget review earlier this year that resulted in a government-wide decision to ‘‘live within our means’’ and oppose additional requests for funding. This is part of our overall emphasis on supporting a

more sustainable rate of increase in domestic discretionary spending.

TITLE I ALLOCATIONS—USE OF UPDATED DATA

Question. Title I was created to target funds and provide supplemental services

to disadvantaged, poor children, and the law requires the Department to use updated counts of poor children in an effort to ensure that funding reflects changes

in the poor student population. Do you support funding for this program that is targeted to poor children by using the most recent count of poor children possible?

Answer. Yes, we do support the use of biennially updated Census poverty estimates in making allocations under the Title I Grants to Local Educational Agencies

program.

TITLE I HOLD-HARMLESS

Question. Do you oppose a Title I hold-harmless provision that ‘‘freezes in’’ funding levels to States despite changes in the poor student population?

Answer. Yes; the President’s 2002 budget request for Title I assumes the application of statutory hold-harmless provisions and not the 100-percent hold-harmless included in appropriations language in recent years.
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SUBCOMMITTEE RECESS

Senator HARKIN. Thank you very much, that concludes the hearing. The subcommittee will stand in recess until 9 a.m., Wednesday, May 23, when we will meet in room SD–138 to hear from the

Acting Director, National Institutes of Health, Dr. Ruth L.

Kirschstein.

[Whereupon, at 10:45 a.m., Thursday, May 10, the subcommittee

was recessed, to reconvene at 9 a.m., Wednesday, May 23.]
(293)

DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

WEDNESDAY, MAY 23, 2001

U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC.

The subcommittee met at 9:04 a.m., in room SD–138, Dirksen

Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Cochran, and Harkin.

DEPARTMENT OF HEALTH AND HUMAN SRVICES

NATIONAL INSTITUTES OF HEALTH

STATEMENT OF RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR

ACCOMPANIED BY:

DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE

DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG AND

BLOOD INSTITUTE

DR. AUDREY S. PENN, ACTING DIRECTOR, NATIONAL INSTITUTE

OF NEUROLOGICAL DISORDERS AND STROKE

DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON

AGING

DR. ALLEN M. SPIEGEL, NATIONAL INSTITUTE OF DIABETES AND

DIGESTIVE AND KIDNEY DISEASES

DR. JACK A. McLAUGHLIN, ACTING DIRECTOR, NATIONAL EYE INSTITUTE

DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. The Appropriations Subcommittee on Labor,

Health and Human Services, and Education will now proceed. This

hearing has been advanced from 9:30 to 9:00 o’clock, because of

other conflicting hearings. We are scheduled to have nominees for

key positions in the Justice Department and also Secretary of

Treasury O’Neil will be testifying before the Foreign Operations

Subcommittee. Since the scheduling was undertaken, we have been

considering the tax bill, and there has been what is called the Filibuster by Amendments.
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We came in at 6 a.m. o’clock expecting on Monday to complete

the action on the bill fairly promptly. We had 17 votes, and adjourned shortly after midnight. Yesterday we had 27 votes, and we

are scheduled to reconvene at 9:30 today, so we will not have as

much time as I would like for this important session. We thought

it important to proceed with this hearing, because we wanted to

finish our subcommittee’s agency hearings to be thorough on examining the Administrations Budget requests

Now, last year, this subcommittee tied a record going back to

1976, completing our work on June 30th, and we had the conference finished on July 27th, and in an effort to get there early

when you divide up $2 trillion, it is good to be at the head of the

line. One of the key reasons that I wanted to be at the head of the

line was to keep the funding going for the National Institutes of

Health.

All of you know what Senator Harkin and I have done in the

leadership role in increasing the funding for NIH. It has been very

difficult. When we appeared before the budget committee 5 years

ago and asked for an extra $1 billion, we were turned down, so we

got a sharp pencil out and established the priority for this unit at

NIH over many, many others.

So the next year we went back to the budget committee and asked for $2 billion, since we got turned down on $1 billion. We

were turned down again and we lost many votes, but finally this

year we won by a very decisive margin. The administration has

come forward with an increase in funding in excess of $2.7 billion,

but Senator Harkin and I are targeting an increase of $3.4 billion

for fiscal year 2002.

We have spent a good deal of our time on the issue of stem cells

as a potential answer to a great many of the maladies, which all

of you know. It has candidly been quite an experience to chair this

subcommittee and to have people come in who are devastated by

their illnesses or the illnesses of their family or friends. No family

in the world is untouched by the maladies. This room has been

overflowing, and we have consistent requests from groups to publicize their own particular problem, and to prevail on NIH to give

them a larger share.

We have had Michael J. Fox coming in on Parkinson’s, and we

have had Jerry Lewis coming in on muscular dystrophy, and the

breast cancer group, and the amyotrophic lateral sclerosis group,

the Alzheimer’s group and children with Juvenile diabetes.

So we have looked to this committee really almost for miracles.

Prime Minister David Ben Gurion of Israel, said, ‘‘If you do not believe in miracles, you are not a realist,’’ and I believe that the potential is unlimited for what you can do.

So that is why I am committed to staying here. It is fairly well

known that I wanted to move on to another subcommittee after

battling the Congress for the budget. I thought it would be easier

to chair foreign operations and deal with the Israeli-Palestinian

conflict than with the Conference Committee on NIH, but then, realized that people were so interested in a continued service, so here

I am.

I do not want to focus on the issue of the response to the letters

that I sent on May 4 on stem cells, but candidly, I am very con-
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cerned about not getting the answers until yesterday. The responses totalled some 70 pages, and we hardly had time to digest

them. I am even more concerned about what I understand may

have been rewriting of the letters. I am going to come to that in

due course, but first, I want to touch on affirmative or substantive

issues, and we welcome Dr. Kirschstein here today, the Acting Director of the National Institutes of Health, having served as deputy

director from July, 1993, until she took over as acting.

She had served as Director of the National Institute of General

Medical Sciences, the first woman to hold the position at NIH. She

came to NIH in 1956 as a medical officer in clinical pathology, with

a BA magna cum laude from Long Island University, and a M.D.

from Tulane University.

Let me express on a personal note to Dr. Kirschstein how appreciative I am of your work, and your cooperation, and your devotion

to your job. So the floor is yours for up to 5 minutes.

SUMMARY STATEMENT OF DR. RUTH L. KIRSCHSTEIN

Dr. KIRSCHSTEIN. Thank you, Mr. Chairman, for those very kind

words. Today, I appear before the subcommittee with my colleagues, the directors of the NIH’s 27 institutes and centers. As you

said, the President’s budget for fiscal year 2002 reflects the administration’s commitment to doubling the NIH budget by fiscal year

2003, and requests $23.04 billion, an increase of $2.8 billion, or

13.5 percent above the 2002 level.

NIH is deeply gratified by the support of the American public

and the Congress, and recently, of the administration. Because of

this unprecedented growth in our budget, we are gaining new

knowledge and translating it into new treatments, diagnostics, and

prevention strategies at a remarkable pace. This is a time of extraordinary scientific opportunity.

As you know, this year we celebrated the mapping of the human

genome, a remarkable accomplishment, but as we look toward next

year, and on to the next decade, our work has only just begun. The

greatest challenges are before us, as are the greatest rewards.

Turning what we know about genes into new approaches for prevention and management of disease will require even more intense

efforts, and the dedication of our best and brightest scientists, as

well as the continued support of the Congress and the nation.

To this end, NIH is expanding and developing a variety of new

initiatives and programs aimed at seizing these new opportunities

in all aspects of biology and medicine, from animal and human molecular studies, and stem cell biology, to clinical studies. We are expanding our clinical research programs in an effort to attract new

young physicians into careers in research, so we are supporting

several new loan repayment programs.

We are expanding our training programs and research efforts in

bioinformatics and computational biology, so that we have the expert tools and personnel to get the most out of a landslide of information emerging from genomics, proteinomics, and imaging technologies, and we are using this new technology and this new

knowledge to reach out to the public and to the health-care providers to help ensure that state-of-the-art information regarding
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the prevention, diagnosis, and treatment of disease is incorporated

into the delivery of care.

As you know, in this regard, just last week, the National Heart,

Lung, and Blood Institute issued major new practice guidelines on

the prevention and management of high cholesterol levels in

adults, the first major update in almost 10 years, and as reported

just last Sunday in The Washington Post, the statins, originally developed to lower cholesterol levels appear to lower the risk of

stroke, diabetes, and Alzheimer’s Disease, as well as the rejection

of certain transplants, and to affect many other disorders as well.

PREPARED STATEMENTS

Mr. Chairman, I have kept my remarks brief, but I and the Institutes directors are here to answer your questions, and to elaborate,

and to assure you that the accomplishments made as a result of

the research will go on in the future. Thank you.

Senator SPECTER. Thank you very much, Dr. Kirschstein.

[The statements follow:]

PREPARED STATEMENT OF DR. RUTH L. KIRSCHSTEIN

Mr. Chairman and Members of the Committee: I am Ruth Kirschstein, the Acting

Director of the National Institutes of Health. I am honored to appear before the

Subcommittee, representing my colleagues, the Directors of the 27 Institutes and

Centers who each have presented a written statement related to the President’s

budget for fiscal year 2002. I shall present an overall view of the total Administration budget for NIH in fiscal year 2002.

The NIH is deeply gratified that, beginning in fiscal year 1999, the support of the

American public, the Congress, and the Administration produced a commitment to

double its funding by 2003. Because of that additional funding, progress in the medical sciences is advancing at a speed we only dreamed of a few years ago. This is

a time of extraordinary scientific opportunity.

Last June, the International Human Genome Consortium completed a working

draft of the human genome sequence. More than 30 genes for human diseases and

disorders, including various cancers, deafness, and birth defects, have already been

identified using this working draft, and scientists are now using the information to

design better means of diagnosing and treating these disorders and of identifying

other genes. New insights and knowledge in biology and new tools, including advanced imaging techniques, computing power, and robotics, allow scientists to move

from studying a single gene and protein to studying entire sets of genes and proteins and understanding their interactions. In all fields of medical research, we are

now ready to move even more rapidly into clinical studies, the means of bringing

advances directly to the patient.

The NIH Institutes and Centers have strategically invested the increases provided

since 1999 to take advantage of the enormous scientific opportunities and to address

essential health needs. Although scientific accomplishments often take many years

to unfold into new diagnostic tools, treatments, and ways to prevent disease before

it strikes, we can already see progress stemming directly from the increased funding. I will cite a few examples that Institute and Center Directors have recorded.

A new project funded by the National Cancer Institute (NCI) supports scientists

who are developing detailed profiles, at the molecular level, of tumors and cancers

of the lymphatic and blood system. The scientists used microarray technology to

look at how thousands of genes are expressed at once, a scale previously unimaginable. This new project, looking at approximately 1.8 million measurements of gene

expression from 96 different samples, revealed that there are two distinct subtypes

of a malignancy called diffuse large B-cell lymphoma (DLBCL). Before this finding,

clinical researchers had been unable to account for the fact that 40 percent of patients with DLBCL respond well to current treatment, yet the remainder die of the

disease. This is just the first demonstration of a technique that promises to revolutionize diagnosis and treatment for lymphoma as well as for other cancers.

The National Institute on Drug Abuse (NIDA) was able, in fiscal year 1999, to

use its increased funds to jump-start the establishment of what has now become a

national clinical research infrastructure for testing treatments for drug addiction.
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From past research, we know that treatment of drug abuse can be effective, but

these treatments had not been adequately applied in community treatment centers.

The National Drug Abuse Treatment Clinical Trials Network (CTN), which was expanded in fiscal year 2000, now provides the infrastructure to bring new treatments

to diverse populations of patients across the country. Since the inception of the

CTN, rapidly and systematically it has grown to include 14 research centers across

the country working in partnership with over 80 community treatment providers.

Patients are already participating in the first seven treatment protocols, which use

both medications that counter addiction and behavioral approaches. Patient brochures have been published in English and Spanish, and an additional 17 new protocol concepts have been submitted to NIDA for review.

Language impairment is a serious problem that affects about 7 percent of all

school-age children in the United States. It has significant consequences for families

and for society as a whole, particularly in regard to cost of education and vocational

training. There has never been a good evaluation of the effectiveness of the usual

interventions for language impairment. A recently developed computerized method

called Fast For Word has received national attention. Scientists supported by the

National Institute of Deafness and Other Communication Disorders (NIDCD) are

conducting a randomized clinical study to compare this intervention, which uses

acoustically modified speech with computer assistance, to computer assistance alone

and to other individualized interventions. The goal is to determine which intervention leads to the greatest improvement in language, the greatest gains in being able

to converse, and the greatest gains in auditory perception, as well as being the most

cost effective.

These examples illustrate some of the ways the Institutes and Centers have invested the budget increases since fiscal year 1999. They not only show great

progress over the short-term, but also illustrate what is required today, in terms

of technology and infrastructure, to take advantage of scientific opportunity and

move basic findings into the practice of medicine.

The President’s fiscal year 2002 budget reflects the continuing commitment to

doubling the NIH budget by fiscal year 2003, requesting $23.04 billion, an increase

of $2.8 billion, or 13.5 percent more than for fiscal year 2001.

Investments have already expanded our knowledge and the practice of medicine

as they have pushed back frontiers. They have also revealed new frontiers-new opportunities to understand diseases, to treat them, to prevent them, and even to cure

them. As a result, the Institutes and Centers have many new research projects underway, all of which will continue well beyond 2003. And given the accelerating rate

of progress and discovery, it is clear that more opportunities will present themselves. We must seize these future opportunities. To illustrate, I will present examples from four areas of research offering particular promise to yield enormous benefits in the form of new knowledge, new treatments, and new strategies for prevention of disease and disability.

GENOMICS AND GENETIC MEDICINE

Now that a draft of the human genome sequence has been completed and is available to all scientists in a public database maintained by the NIH, opportunities

abound. For example, future large-scale sequencing will be aimed at developing data

to help scientists interpret the human sequence. One of the most efficient ways to

do this is to obtain the genetic sequences from related organisms. A comparison between the genomes of the human and other organisms such as the non-human primates, mouse, rat, fruit fly, and yeast will help identify important features which

point scientists toward genes likely to cause human disease.

There are a number of disorders that are primarily due to alterations in a single

gene. How that disease manifests itself is complex and varies greatly among patients. These differences, thought to be caused by other genes that influence the disease-causing genes, will be a focus of research. Studying these so-called modifier

genes will help us understand variations in the rate at which disease progresses and

how individuals respond to therapy. In addition, these studies will enable earlier diagnosis and more accurate prognosis, and may even provide novel targets for therapy that are more useful than the gene primarily involved in causing a disease.

Together these approaches will help us identify genes involved in, for example,

heart, lung, and blood disorders; cancer; mental and developmental disorders, including Alzheimer’s disease and autism; diabetes; kidney disease; the muscular dystrophies; and the causes of aging; adverse reactions to drugs; and babies born fullterm but with low weight.
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CLINICAL RESEARCH: TAKING BASIC DISCOVERIES INTO MEDICAL PRACTICE

The NIH will continue to expand its emphasis in fiscal year 2002 on clinical research, the means by which basic findings relating to behavior, to molecules, and

to genes, can be tested and translated into medical practice and improvements in

public health.

Several Institutes will begin or will expand their clinical trials networks located

nation-wide, ready to evaluate new prevention strategies, drugs, and vaccines in

large numbers of patients. Other initiatives in clinical research planned for fiscal

year 2002 include regional centers of excellence for research on rare diseases, research on care at the end of life, and the self-management of the chronic illnesses

which plague our society.

The NIH is expanding its programs aimed at building the capacity to conduct clinical research. For example, the 106th Congress authorized several new Loan Repayment Programs (LRPs), which we regard as vitally important in recruiting new clinical researchers. Two of these new programs, the Extramural Clinical Research and

the Pediatric Research LRPs will be trans-NIH programs that will be supported by

nearly all the Institutes and Centers in the fiscal year 2002 President’s request. In

addition, we will support the Clinical Research LRP for Individuals from Disadvantaged Backgrounds and the LRP for Minority Health Disparities Research. Two programs started in fiscal year 1999, the Mentored Patient-oriented Research Career

Awards and the Mid-Career Investigator Awards in Patient-oriented Research, will

be expanded to meet the increasing demand for clinical investigators of high quality.

Participation of patients and other volunteers in clinical research is critical to

progress. The NIH’s national clinical trials database, called ClinicalTrials.gov, continues to provide the public with enhanced access to new information about clinical

trials. In addition to learning about NIH-supported clinical trials, the public can

gain access to information about such trials for serious or life-threatening conditions

sponsored by other Federal agencies as well as by industry. This expanded capacity

provides an even greater array of facts about which clinical trials are being conducted and whom to contact about participating in them.

INFRASTRUCTURE AND ENABLING TECHNOLOGIES

As medical research generates more and more data, there is a pressing need for

scientists with expertise in biocomputing and bioinformatics. To meet this need, the

NIH will significantly expand its current program in bioinformatics and computational biology. New research initiatives will include: Centers of Excellence in Biocomputing and Bioinformatics, grants to institutions to train people in these areas

of science, and a joint NIH/National Science Foundation program to support research in mathematical biology.

Rapid progress in medical research is more and more dependent upon the availability of advanced instruments and other devices that often cost well in excess of

half a million dollars each. The fiscal year 2002 President’s budget request provides

funds so that the NIH can support high-end instrumentation for basic and clinical

scientists. Such instrumentation includes very high-field NMR spectrometers, extremely sophisticated imaging systems and electron microscopes, high-resolution

mass spectrometers, and high-performance supercomputers.

The fiscal year 2002 President’s budget also requests $40.2 million for the newly

legislated National Institute of Biomedical Imaging and Bioengineering (NIBIB), the

focus of which is to develop new knowledge, create new technologies, and train researchers able to integrate fully the quantitative sciences with medical research.

The programs described above are over and above the $1.2 billion the Institutes and

Centers currently devote extramurally to the physical sciences, including mathematics, chemistry and other physical sciences.

ELIMINATING HEALTH DISPARITIES

We are expanding our commitment to programs focused on the health needs of

minorities and the medically underserved, as well as programs designed to increase

the number of minority scientists.

The new National Center on Minority Health and Health Disparities (NCMHD)

was established in December 2000 and is leading NIH’s efforts to plan and coordinate research focused initially on racial and ethnic disparities. The Center’s mission

will expand to include studies related to medically underserved populations, including people who live in rural settings remote from medical care. The President’s

budget for fiscal year 2002 requests a 20 percent increase to $158.4 million for the

new Center over the fiscal year 2001 estimate. In addition, the budget for the Office

of Research on Women’s Health would increase by about $28 million, to nearly $50
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million in total, to support new research and career development for women in

science.

The other Institutes and Centers will continue to expand their emphasis on health

disparities as well. For example, a major clinical trial involving African-Americans

is designed to identify ways to slow the progression of kidney disease due to hypertension. The study compares two major classes of drugs used to treat high blood

pressure—beta blockers and ACE inhibitors and, when completed, will enable the

NIH to provide and disseminate information about the optimal treatment of hypertension to prevent end-stage kidney disease in this minority group. NIH will also

award grants to establish formal partnerships between NIH-designated cancer centers and minority-serving institutions such as historically black, Hispanic, and tribal

colleges and universities. These partnerships will support research projects and research training in the minority-serving institutions, foster long-term collaborations

between scientists and faculty that examine the disproportionate incidence and mortality from cancer in minority populations, and improve the effectiveness of cancer

research, education, and outreach activities.

This is, Mr. Chairman, only a small sampling of our present and future research

portfolios. The fiscal year 2002 budget request enables the NIH to sustain momentum of research already in progress, to open the way to new research opportunities,

and to augment both our research infrastructure and our human capital. In fiscal

year 2002, the NIH will fund 36,143 research grant awards, the highest annual

total ever awarded.

The budget request includes a total of $135 million for the Institutional Development Award (IDeA) program, an increase of $35 million over fiscal year 2001. This

increase will bring our support to a total of $75 million for the Biomedical Research

Infrastructure Network (BRIN) subcomponent of the IDeA program, which has been

developed to enhance the capacity of institutions located in States that have not

fully participated in medical research, and are eligible for participation in the IDeA

program.

Research and development contracts increase by 20 percent. The larger increase

in R&D contracts, as compared to other extramural mechanisms, includes $28 million to support the two new loan repayment programs I described earlier.

The fiscal year 2002 President’s budget also includes an increase of 12.5 percent

for Research Management and Support (RM&S). As the NIH research budget grows,

it is important to increase activities under the RM&S, so that we can effectively

manage our programs. The RM&S includes support for the NIH professional staff

who guide and monitor research activities of the Institutes, for example, those who

oversee protections for volunteers participating in research, and who design and

conduct programs to disseminate the results of NIH research to the public and to

health care professionals.

This request will provide a 10 percent stipend increase for pre-doctoral and postdoctoral trainees and will permit us to recruit and retain the best and brightest scientists in careers in medical research. In the fiscal year 2002 President’s budget,

Buildings and Facilities (B&F) would be funded at $306.6 million. Three projects are

particularly important to our research plans: The John Edward Porter Neuroscience

Research Center, the Central Vivarium/Animal Research Center, and the Building

10 Revitalization Program to repair and renovate the aging facility used for clinical

studies. The budget request also includes an increase from $75 million in fiscal year

2001 to $97 million in fiscal year 2002 in programs for construction and renovation

of extramural research facilities through the National Center for Research Resources.

Consistent with the Administration’s initiatives to combat drug abuse, the National Institute on Drug Abuse (NIDA) received an increase of 16.2 percent in the

fiscal year 2002 President’s budget request. In addition, the request includes funds

for the Oravax smallpox vaccine contract managed by the Centers for Disease Control and Prevention ($32 million) and for intra-governmental support for development of anthrax vaccine ($5 million) and a vaccine production facility ($5 million).

Also included in the budget request is $10 million to begin the establishment of

a system of sanctuaries for chimpanzees to provide lifetime care when they are no

longer needed in research supported by Federal agencies. This system of sanctuaries

was authorized by law in 2000.

Mr. Chairman, this concludes my opening statement. I would be glad to respond

to any questions.
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PREPARED STATEMENT OF DUANE ALEXANDER, M.D., DIRECTOR, NATIONAL INSTITUTE

OF CHILD HEALTH AND HUMAN DEVELOPMENT

Mr. Chairman and Members of the Committee: I am pleased to present the fiscal

year 2002 President’s budget request for the National Institute of Child Health and

Human Development (NICHD) of $1,096,650,000, which reflects an increase of

$117,744,000 over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

The mission of the NICHD extends over much of the human life span, from the

time a single egg is fertilized and develops into an infant, through the childhood

and teenage years, through the young adult and reproductive years, to the health

concerns of mature men and women. Our research seeks to answer questions important to everyone: How can parents have children at the times they want them? How

can all children be born healthy and mothers avoid the adverse consequences of

pregnancy? How can every child reach adulthood free of disease and disability, able

to achieve his or her full potential? How can we ease the burden of physical or mental disability to enable all individuals to participate in society as fully as possible?

Since the Institute was established almost 40 years ago, we have made enormous

strides in answering these questions and improving the lives of millions of Americans. Through research, we have identified, and eliminated or reduced, many of the

causes of mental retardation and as a result, far fewer children and adults have

mental disabilities. Through research, we have reduced infant mortality and as a

result, many more infants have grown into healthy children and adults. Through

research, we have found ways to reduce the transmission of the HIV virus from

mother-to-infant and as a result, AIDS in children has markedly declined in this

country. And through research, we have demonstrated cost-effective methods of significantly reducing the rate of HIV transmission in developing countries.

We faced formidable scientific challenges in achieving these advances, and we face

many challenges today. Yet these challenges are dwarfed by the excitement and

hope of soon finding answers to questions we have wondered about for decades.

NEW TECHNOLOGY TO HELP ANSWER A FUNDAMENTAL QUESTION

For many years the answer to a critical scientific question has eluded us: what

actually triggers labor in a pregnant woman, at term or at preterm? We know many

things that correlate with a woman going into labor, but we have never identified

the mechanism that triggers labor. This is an important question. Preterm birth is

the leading cause of infant sickness and death among African American babies and

the second leading cause of infant death among all races. Despite some wonderful

and heartwarming stories that occasionally appear in the media about a premature

infant surviving, the long-term outlook faced by very premature infants can be

bleak.

Now, for the first time, the human genome project has provided us with the basis

for a new technology called microarrays that will allow us to compare the active

genes from pregnant women who begin labor prematurely with active genes from

those who are not in labor or who deliver their babies after the full nine months.

This comparison will help us to identify the gene products that are responsible for

initiating labor. Armed with this knowledge, we can learn how to stop, postpone,

or, if needed, induce labor. So we have within our reach the hope of addressing the

single biggest cause of infant mortality, premature birth. And in the process of answering this important question, we can help eliminate the significant racial disparity in infant mortality.

NEW COLLABORATIONS TO ELIMINATE RACIAL DISPARITIES IN SIDS

As you know, we have had extraordinary success in reducing another cause of infant mortality, Sudden Infant Death Syndrome or SIDS. Since the Institute initiated

the Back to Sleep campaign in 1994 to reduce the risk of SIDS, the death rate from

SIDS has declined by 40 percent. Yet this decline has been less pronounced among

African American infants. In fact, the SIDS rate among African American infants

is greater than twice that of white infants. So in collaboration with several national

African American organizations, we have initiated an outreach program to reduce

the risk of SIDS among African American infants. The organizations, which include

the National Black Child Development Institute, the Women of the NAACP, the
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Alpha Kappa Alpha sorority, and 100 Black Women, among others, are conducting

one-to-one training sessions in communities throughout the country to inform African American parents and care givers about back sleeping and other ways to reduce

the risks of SIDS.

BEHAVIORAL INTERVENTIONS TO IMPROVE LEARNING

Education is a cornerstone of healthy behavior and reading provides the foundation for education. Children who have difficulty reading are at risk for failure in

school, failure at work, and failure at the many activities required to navigate successfully as an adult in our society. NICHD research has demonstrated that using

teaching techniques based on phonemic awareness results in most children being

able to read by the end of the third grade. As you recall, in collaboration with the

Department of Education, as directed by Congress, the Institute convened a National Reading Panel in 1998 to review the evidence from reading research and

make recommendations for the most effective methods of teaching children to read.

In the largest and most comprehensive evidence-based review of research on how

children learn reading ever conducted, the Panel reviewed more than 100,000 experimental and quasi-experimental research studies. The Panel report strongly endorsed the findings and instructional approaches from NICHD’s research. We are

now collaborating with the National Institute for Literacy to disseminate the Panel’s

findings to administrators, teachers, and parents.

IMPROVING THE ENVIRONMENT FOR CHILDREN TO GROW

Compared to adults, children are at increased risk from environmental influences.

Children are not just small adults. Yet their developing bodies are often exposed to

the same level of contaminants as are adults. In some instances, such as ingesting

lead from peeling lead-based paints, children may be exposed to greater contaminants than are adults. What happens to a child before birth and early in life will

affect the child’s subsequent growth, development, and well being

For this reason, the President’s Task Force on Environmental Health and Safety

Risks to Children recommended a longitudinal cohort study of environmental impacts on children to identify and quantify the risks that children face. Several Federal agencies, among them, the NICHD, the National Center for Environmental

Health of the CDC, and the Environmental Protection Agency, are participating in

planning this study. The study will enroll 100,000 children, beginning from before

birth, and will gather information on environmental influences and outcomes until

the children reach at least age 21. Methodological and pilot studies are planned for

fiscal year 2001 to 2003 and the full study will be initiated in 2004. This planning

phase will also allow us to answer key questions about the administration of the

study. This is the largest such prospective study ever undertaken in this country

and we look forward to working with this committee in addressing these exciting

and challenging issues.

REDUCING HIV AND AIDS AMONG ADOLESCENTS

The advent of highly active antiretroviral therapy, or HAART, in the mid 1990s

dramatically improved the outlook for many people living with HIV infection. But

for adolescents infected with HIV, HAART posed a great promise and a greater challenge. The therapy holds the promise of converting HIV infection into a chronic but

manageable condition that gives young people time to benefit from emerging therapies. The challenge is that many HIV positive adolescents have little experience

with medications, therapeutic regimens, or adherence to therapy. In the absence of

a strong social support system, many HIV positive adolescents on HAART do not

recognize the importance of taking medications consistently, on time, every day,

without fail. The stakes are high because if the drugs are taken for short bursts

or erratically over long periods, the probability of drug resistance increases. To help

treat HIV positive adolescents and to develop effective prevention strategies, the

NICHD established the Adolescent Medicine HIV/AIDS Research Network. By providing training, reinforcement, and a strong social support system, the Network has

demonstrated that adolescents can be motivated to remain on an exacting medication regimen. Moreover, the adolescents have been trained in peer counseling techniques and they are providing a strong prevention message to friends and classmates in their social network.

AUTISM RESEARCH

In our autism research, we continue to make important discoveries that help us

understand this condition in the hope of finding more effective treatments. Recently
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researchers funded by NICHD and other NIH Institutes identified a gene that may

predispose people to developing autism. The gene, known as HOXA1, plays a crucial

role in early brain development. This finding strongly suggests that a gene controlling early brain formation may underlie the development of autism in a large number of cases. Together with other NIH Institutes, we are also actively implementing

the provision of the Children’s Health Act of 2000 that calls for the establishment

of the Centers of Excellence on Autism Program. As an initial step toward establishing the Centers, we are issuing Requests for Applications for Center Development grants which will allow potential Centers of Excellence to marshal the resources necessary to submit strong proposals when we request applications for the

actual centers.

WOMEN’S HEALTH

Research in women’s health continues to be a high priority for the Institute. We

are supporting research to develop effective treatments for uterine fibroids, the

number one reason for hysterectomies and a leading cause of infertility, particularly

among African American women. With the Office of Research on Women’s Health,

we are conducting research to understand, treat, and reduce conditions such as pelvic organ prolapse and incontinence that can develop as a result of childbirth or the

aging process. We are also conducting research to diagnose and treat vulvodynia,

a particularly painful condition that affects the reproductive, sexual, and physical

health of women. We have also initiated gender specific-research to understand how

women’s unique reproductive physiology influences the transmission and progression of HIV–1. This research will lay the foundation for new prevention and treatment strategies to reduce AIDS among women. And because some conditions such

as uterine fibroids, ectopic pregnancies, and preterm births disproportionately affect

African American women, NICHD has helped establish a collaborative partnership

between reproductive scientists at minority institutions and NICHD-funded programs. The new Reproductive Science Centers at Minority Institutions are designed

to increase the number of minority investigators trained to study reproductive

health issues, particularly those relevant to racial and ethnic populations.

In closing Mr. Chairman, I look forward to working with you and the subcommittee and will be happy to provide answers to any questions you have.

PREPARED STATEMENT OF DR. JAMES F. BATTEY, JR. DIRECTOR, NATIONAL INSTITUTE

ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

Mr. Chairman and Members of the Committee, I am pleased to present the President’s budget request for the National Institute on Deafness and Other Communication Disorders (NIDCD) for fiscal year 2002, a sum of $336,757,000 which reflects

an increase of $35,631,000 over the comparable fiscal year 2001 appropriation. The

NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance

data is NIH’s second annual performance report which compares our fiscal year

2000 results to the goals in our fiscal year 2000 performance plan. As performance

trends on research outcomes emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.

The United States recently celebrated the 10th Anniversary of the signing of the

Americans with Disabilities Act, a law enacted in 1990 to promote integration, equal

opportunity, and inclusion of millions of Americans with a disability. Even with this

legislation, individuals affected by a communication disability may still find it difficult to enter the labor force and live a productive life because of the daily challenges they face. It is often impossible for them to perform the simple acts of speaking, listening, or otherwise making their wants and needs understood. Disorders of

hearing, balance, smell, taste, voice, speech, and language exact a significant economic, social, and personal cost for many individuals. The NIDCD supports and conducts research and research training in the normal processes and the disorders of

human communication that affect approximately 46 million Americans. Human

communication research now has more potential for productive exploration than at

any time in history. With substantive investigations conducted over the past decades, the advent of exciting new research tools and new highly trained scientists,

the NIDCD is pursuing a more complete understanding of the scientific mechanisms

underlying normal communication and the etiology of human communication disorders. Examples of this research are highlighted in this statement for the record.

The Speed of Sound: Rapid Motor Protein of Inner Ear Identified.—Millions of

Americans, especially middle-aged and older individuals, suffer from mild to moderate hearing loss. It is likely that a defect in the most sensitive cell types in the
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inner ear, the hair cells, causes this type of hearing deficit. The hair cells of the

inner ear are sensory receptor cells that give humans and other mammals the remarkable ability to hear. As sound travels to the ears, down the ear canal, through

the bones of the middle ear and into the inner ear, the outer hair cells amplify the

mechanical vibrations produced by the sound through a process known as

electromotility. These electrical changes in the cell allow it to rapidly change its

length and stiffness. The length changes amplify the vibrations, which are sensed

by the other hair cells (inner hair cells) that send auditory information to the brain.

NIDCD-supported scientists have recently identified the gene that codes for the

motor protein responsible for outer hair cell electromotility as well. Prestin (from the

musical term presto, indicating a rapid tempo) was selected as the name of the gene

to emphasize one of the most interesting features in the cellular motor process, its

speed in changing the length of outer hair cells. Outer hair cells can elongate and

contract at rates close to 100,000 times a second! Future research on Prestin should

lead to significant advances in understanding the auditory system, and may lead to

the development of new therapeutic measures for hearing impairment.

Genes Responsible for Hereditary Hearing Impairment.—NIDCD-supported scientists continue to make impressive scientific progress in mapping and cloning

genes responsible for hereditary hearing impairment. Over the past few years, the

chromosomal location of over 60 genes whose mutation results in hereditary hearing

impairment have been identified. In the past three years, nearly 20 genes have been

identified whose mutations cause hereditary hearing impairment. The identification

of these genes enables scientists or clinicians to rapidly identify individuals carrying

the defective gene even if the hearing loss has a delayed onset and is not yet evident. In addition, the identification and isolation of genes responsible for hereditary

hearing impairment immediately provide a powerful tool to determine how the mutation results in deafness by targeted gene mutations or deletions in an animal

model. The animal model can provide information on which structures of the ear

are affected, as well as the molecular and physiological defects that result in hearing impairment, and provide a system to test potential new therapies.

Gene Cloned for Syndrome That Causes Deafness and Blindness.—Usher syndrome type 1 is an inherited sensory defect involving profound deafness, balance

disorders and eventual progression to blindness. It is the most common genetic

cause of a syndrome leading to blindness and deafness in Americans. Studies of affected families in the U.S. and abroad indicate that there are more than six distinct

genes whose mutations result in this devastating inherited disease. NIDCD-supported scientists are collaborating with researchers from France, Germany, Lebanon, and Japan to identify the defective gene responsible for one form of this disorder, USHER1C. They identified the defective USHER1C gene in unrelated families in the U.S., Lebanon, and Europe. The finding will allow for genetic-based diagnosis of Usher syndrome before a deaf individual begins to lose sight. Early diagnosis will permit the study of the complete progression of retinal degeneration and

provide opportunities in the future for possible treatment before the retinal degeneration begins.

An Animal Model for Pendred Syndrome.—Individuals with Pendred syndrome

have sensorineural deafness and goiter (enlargement of the thyroid gland). In a collaboration between National Human Genome Research Institute and NIDCD intramural scientists, genetic analysis revealed that mutations in the Pendrin gene occur

in deaf individuals without thyroid disease, indicating that the gene is responsible

for a much broader spectrum of deafness than only those individuals with Pendred

syndrome. To determine the cause of this disorder, the Pendrin gene was deleted

in mice and analysis of this mouse model was conducted. The mutant mice were

found to be deaf and have a variable spectrum of balance problems similar to symptoms of individuals with the syndrome. The scientists observed swelling in parts of

the developing inner ear in the mutant mouse embryos. The resulting fluid imbalance within the inner ear subsequently leads to the destruction of the sensory hair

cells necessary for hearing. This mutant mouse model provides important clues

about inner ear pathology associated with the human syndrome.

Otitis Media is Linked to a Strong Genetic Component. Otitis media (OM), or middle ear infection, is the most common reason why a sick child visits a physician,

and is the most common reason that children receive antibiotics or undergo surgery.

Previous anatomical, physiological, and epidemiological studies have raised the

question of whether the likelihood of having multiple bouts of this common disease

has a hereditary component. Studying twins and triplets to determine the extent to

which this common disease might be due to genetic factors, NIDCD-supported scientists have determined that there is a strong genetic component to the rate of occurrence of otitis media in children. The implications of these findings are numerous

for both immediate and future improvements in treatment of OM. For example, pri-
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mary care physicians can follow siblings and offspring of affected children as potentially high-risk cases. These children could be monitored more closely for early detection and treatment of disease, reducing the risk of hearing loss. In addition, identification of the genetic factors that cause this disease could eventually result in genetic diagnostic tests to identify individuals with enhanced risk. Finally, studies of

the molecular basis for the increased risk and frequency of otitis media could lead

to new approaches for intervention and treatment of this disease.

Molecular Biology of Taste Signal Transduction.—A long history of NIDCD-supported research has shown that taste perception involves four basic taste qualities:

sweet, sour, salty, and bitter. In a recent study, a fifth taste has been recognized

and its taste receptor identified—umami—the taste of monosodium glutamate or the

taste associated with protein-rich foods. From this finding, scientists have determined that each taste quality appears to be mediated by a distinct biochemical

pathway. Salty and sour substances activate specialized ion channels in the membrane of the taste receptor cells in the taste buds in the tongue. In contrast, umami-

, sweet-, and bitter-tasting substances activate another pathway involving G-protein-coupled receptors. Scientists recently characterized the diverse structure, function and expression of a large family of mammalian G-protein-coupled receptors,

called T2Rs, which are selectively expressed in a subset of taste receptor cells of the

tongue and palate. T2R receptors were shown to mediate bitter taste perception in

humans and mice.

The Genetics of Stuttering.—Stuttering is a speech disorder in which the normal

flow of speech is disrupted by frequent repetitions or prolongations of speech sounds,

syllables or words. Currently, there is no cure for the 3 million Americans who stutter. The precise causes of stuttering have not been identified but there is evidence

that it is genetically determined. NIDCD intramural scientists have been conducting

a large study that involves individuals who stutter and their families. From this

group, the scientists have recently identified a single region of the genome that may

contain one or more genes involved in stuttering. Understanding the genetic causes

of stuttering will eventually lead to treatment for this age-old disorder.

Language Impairment in Autism.—NIDCD-supported scientists were the first to

investigate the language profiles on a large sample of children with autism. One

cardinal feature of autism is the delay or absence of spoken language. In the study,

the researchers found significant differences in language skills, although articulation skills (or how the sounds of the language are produced) remained normal in

all the children. Different subgroups of children with autism were identified on the

basis of their performance on the language measures. Some children with autism

have normal language skills, while others have language skills significantly below

their age expectations. The scientists also observed that the performance profile

across the standardized measures for the language-impaired children with autism

was similar to the profile of children with specific language impairment (SLI). These

findings suggest that there may be overlapping or shared characteristics among

families with SLI and autism. Future studies will need to investigate the mechanisms underlying language processing in children with SLI, autism and perhaps

other disorders, in order to advance the understanding of language disorders in children.

Expanding Efforts to Identify Hearing Impairment in Newborns.—As efforts increase in many States to screen all newborn infants for hearing impairment before

discharge from the hospital, more infants will be identified with hearing impairment

at an early age when appropriate intervention can be started that will optimize

their long-term speech and language skills. NIDCD-supported scientists have examined the importance of age at enrollment in intervention programs and subsequent

language outcomes for a group of deaf and hard-of-hearing children. Significantly

better language scores were associated with early enrollment, and high levels of

family involvement correlated with positive language outcomes. These results provide further evidence that children will benefit when early identification of hearing

loss is combined with an early intervention strategy that actively involves family

participation.

Advances in the genetics of hereditary hearing impairment and in the early identification of hearing impairment have now converged, leading some clinicians to suggest genetic testing/evaluation be performed on all infants who are identified with

a hearing loss at birth. In consideration of these developments, the NIDCD is planning a study to address the clinical relationship between genetic and audiologic/

otologic information, as well as to assess the clinical validity, value and utility of

genetic testing in the diagnosis, treatment and management of hearing impairment.

Cochlear Implants Are Cost Effective.—Over 20,000 Americans with profound

hearing impairment have received cochlear implants with approximately one-half of

the recipients being children. This device converts sound into electrical impulses on
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an array of electrodes surgically inserted into the inner ear, bypassing the hair cells

and stimulating the auditory nerve directly. NIDCD-supported studies have shown

that children with cochlear implants exhibit improvements in speech perception,

speech production, and better language and reading performance. In addition, a recent analysis showed that cochlear implants improve the children’s quality of life,

and result in a net saving to society. The cost benefit is in the form of fewer demands on special education and greater wage-earning opportunities for implant recipients.

PREPARED STATEMENT OF DR. MARVIN CASSMAN, PH.D., DIRECTOR, NATIONAL

INSTITUTE OF GENERAL MEDICAL SCIENCES

Mr. Chairman and Members of the Committee, good morning. I am pleased to

present the President’s budget request for the National Institute of General Medical

Sciences (NIGMS) for fiscal year 2002, a sum of $1.720 billion, which reflects an increase of $180 million over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second performance report, which compares our fiscal year

2000 results to the goals in our fiscal year 2000 performance plan. As performance

trends on research outcomes emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.

The NIGMS mission is to support basic biomedical research in disciplines ranging

from genetics, chemistry, and cell biology to trauma and burn research. These studies, often carried out in organisms such as yeast, fruit flies, and bacteria, yield a

fundamental understanding of the biological processes that underlie all of the functions of life. Insights into the basic behavior of living systems provide the underpinning for subsequent discoveries regarding the way these processes go awry and lead

to disease.

It is becoming increasingly clear that research started with the goal of understanding unknown or poorly understood processes can immediately lead to insights

about the mechanisms underlying diseases. One example is a research effort focused

on a rather esoteric protein that is involved in the way cells process the instructions

from DNA. As part of this study, the NIGMS-supported investigators closely examined the makeup of the protein. From its somewhat unique structure, they inferred

that the protein could trigger diseases that result from the body’s reaction to its own

materials, a process known as autoimmunity. Interestingly, this discovery was entirely incidental to the original investigations. When the scientists tested this hypothesis, they found a strong correlation between high levels of immune response

to this protein and the occurrence of a disease called systemic lupus erythematosus.

This suggests that the occurrence of lupus is a consequence of some aberrant event

that results in the accumulation of this protein or in the body’s response, or both.

We anticipate that this discovery will provide a major tool to allow accurate diagnosis of lupus as well as a clue to possible cures.

Another example of the rapid conversion of a basic understanding of biology to

an understanding of disease processes is found in studies being done on copper. Although copper is most often associated with pennies or the pipes used in plumbing,

the metal is also an essential component of biological systems. However, when free

in cells and organisms, even a small amount of copper can be very toxic. How does

the body process copper in a way that does not cause irreversible damage? NIGMS

grantees discovered proteins that ‘‘chaperone’’ copper and protect it from interacting

with other cellular components until it reaches its proper destination. These proteins are called ‘‘metallochaperones.’’ Some are specific for transporting copper, and

some are specific for transporting other essential metals. There are several known

hereditary diseases that are the result of defective copper metabolism, and these

diseases frequently cause neurodegenerative disorders. It is important to understand just what is going wrong in individuals with these problems. Recent detailed

studies on the mechanism of copper transport have shown how the chaperones that

carry copper are implicated in the events leading to these diseases.

Finally, a major thrust in modern medicine is the attempt to understand individual responses to drugs based on a person’s genetic make-up. For example, certain

drugs used to treat cancer can have widely variable effects in patients, and many

of these treatments have serious toxicities. On occasion, patients are literally

poisoned because their bodies cannot get rid of, or ‘‘clear,’’ a drug. For example, patients given the same dose of a commonly used chemotherapy drug, docetaxel, can

have wide variations in the amount of time it takes to clear the medication. A solution to this problem may come from many years of basic studies on the behavior
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of a drug-metabolizing protein nicknamed ‘‘CYP3A4.’’ This protein chews up many

different drugs, including docetaxel. An NIGMS grantee has developed a simple

breath test to measure the activity of CYP3A4, and a small clinical study has shown

that patients who exhibit low activity of the protein suffer the greatest docetaxel

toxicity. Since blood tests have previously failed to predict docetaxel toxicity, the

breath test may offer a promising tool to help physicians administer this drug more

safely.

RECENT RESEARCH INITIATIVES

NIGMS has recently begun a number of major research initiatives, and I would

like to describe our progress in three of them. The first is in the area of

pharmacogenetics, an example of which is the docetaxel toxicity research I just described. The goal of this research initiative is to identify the genetic basis of individual variations in drug response, and ultimately to develop tools that will allow

individual differences to be determined before drugs are prescribed. We have funded

9 research groups for a total of $12.8 million in the first year. NIGMS leads the

research initiative, and five other NIH components are cofunding projects. The other

NIH components are the National Heart, Lung, and Blood Institute; the National

Cancer Institute; the National Human Genome Research Institute; the National Library of Medicine; and the National Institute of Environmental Health Sciences.

The centerpiece of the program is the development of a database that will link gene

variations to their cellular and molecular consequences, and ultimately to their

physiological outcomes. Because many of these studies will initially be on defined

populations we have established a Populations Advisory Group to provide advice on

how to best proceed with such research. We established a second advisory group to

provide a liaison to the pharmaceutical industry. Although this industry is doing a

great deal of work in pharmacogenetics, much of it is proprietary. However, there

are opportunities for mutually beneficial interactions, and this advisory group has

been established to identify those areas.

The second major research initiative is in the area of structural genomics. The

goal is to determine the three-dimensional structures of all proteins in nature,

through a combination of direct experiments and theoretical analysis. Proteins are

the worker molecules in every living thing. By determining the structures of proteins, we are better able to understand how each protein functions normally and

how faulty protein structures can cause disease. Scientists can use the structures

of disease-related proteins to help develop new medicines and diagnostic techniques.

The project was begun in September 2000 through funding nearly $30 million

worth of awards to seven consortia that total 41 participating institutions. These are

pilot programs to determine the most effective approaches that will result in rapid

production of detailed protein structures. It is important to note that the NIGMS

research initiative is part of a world-wide activity in structural genomics that also

includes several industrial participants. Together with the Wellcome Trust in the

United Kingdom, NIGMS organized an international structural genomics meeting

that was held in England in April 2000. A second international meeting was held

in the Washington, DC area in April 2001.

The third Institute research initiative provides support to ‘‘glue together’’ groups

of investigators working on significant problems that could not be solved if the scientists worked independently. Like the other two research initiatives, it involves the

formation of a network of researchers who collaborate and share their results to

speed progress toward a major goal. All of these projects reflect changes in how biomedical research is done today. There is an increased emphasis on large-scale and

collaborative approaches to important scientific questions. These include studies of

complex systems that involve the interaction of many components, such as all of the

activities that go on within a single cell and the ways that cells and organs ‘‘talk’’

to each other.

Studying complex systems requires the contributions of more than just biological

scientists. It requires the expertise and approaches of physicists, mathematicians,

computer scientists and engineers, all of whom are in a unique position to organize

and analyze the vast amounts of data generated by studies of complex systems. To

address this need, NIGMS has started programs to encourage these scientists to join

their expertise and interests with those of biomedical researchers.

RESEARCH TRAINING

NIGMS remains committed to preparing ‘‘a cadre of versatile scientists and engineers for research and teaching careers,’’ investing in ‘‘an educational system that

creates a reservoir of flexible talent for the work force,’’ and ensuring ‘‘opportunities

for the participation of all groups in science and engineering.’’ These goals, which
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are quoted from a 1998 Office of Technology Assessment report on the objectives of

Federal training programs, mirror the Institute’s interests. We accomplish these

goals through a variety of mechanisms, two of which I will mention. The first is our

predoctoral training programs, which have been widely recognized as a means of

identifying, stimulating, and rewarding quality research training. They encourage

interdisciplinary training, which is a central requirement of all of our training programs. Two recent reports, one by the National Academy of Sciences and one an

internal NIH study tracking the career progression of former trainees, have noted

the value of these programs in generating a highly qualified group of investigators.

In order to encourage ‘‘opportunities for the participation of all groups in science

and engineering,’’ we require that our training programs make active efforts to recruit and retain underrepresented minorities. Additionally, our Minority Access to

Research Careers (MARC) Program has a strong focus on research training, primarily at the undergraduate level. In fiscal year 2000, we supported 644 students

at 62 institutions through this program. Although this is a program of very long

standing, since 1975, we have several other programs focusing on the training of

underrepresented minorities in science, a number of which have been initiated in

the past few years. These programs are coupled to intensive outreach efforts that

are designed to improve the capabilities of institutions to participate in Federal programs and to identify new approaches to bring underrepresented minorities into biomedical research.

HEALTH DISPARITIES

NIGMS has several special activities in the area of health disparities. One is a

new collaboration with the Indian Health Service to enhance the capacity and skills

of tribal organizations and Native American researchers to conduct high-quality biomedical and behavioral health research and to apply successfully for competitive research grants.

By its very nature, our pharmacogenetics research initiative will likely reveal new

information linking differences in response to medicines with genes that are more

common in certain population groups. Such knowledge could contribute to a reduction in health disparities by improving doctors’ ability to identify and treat individuals who have these genes. Beyond these general benefits, we are planning to offer

research grant supplements for studies that are specifically related to health disparities in response to medicines.

Finally, a proposed NIGMS health disparities initiative would focus on differences

between various population groups in the physiological response to traumatic injury.

New information about such differences could improve doctors’ ability to anticipate

how trauma patients are likely to fare, especially which patients are at higher risk

of developing a potentially fatal complication called systemic inflammatory response

syndrome.

CONCLUSION

In conclusion, NIGMS sustains and develops programs that provide the research

and research personnel required to ensure the continued progress of biomedical research. Our many accomplishments attest to our success in this endeavor, and our

recent research initiatives should help us make even more significant contributions

to the biomedical research enterprise in the years ahead.

Thank you, Mr. Chairman. I would be pleased to answer any questions that you

may have.

PREPARED STATEMENT OF DR. FRANCIS S. COLLINS, M.D., PH.D., DIRECTOR,

NATIONAL HUMAN GENOME RESEARCH INSTITUTE

Mr. Chairman and Members of the Committee: During fiscal year 2000, Human

Genome Project scientists capped the achievements of the last decade with a historic

milestone—the complete initial reading of the text of our genetic instruction book.

At present, roughly 93 percent of the 3.1 billion bases of the human genome are

freely available in public databases. This is an awesome step toward a comprehensive view of the essential elements of human life, a perspective that inaugurates a

new era in medicine where we will have a more profound understanding of the biological basis of disease and develop more effective ways to diagnose, treat, and prevent illness.

Between March 1999 and June 2000, the production of human genome sequence

skyrocketed. During this time, the international collaborators in the Human Genome Project sequenced DNA at a rate of 1000 bases per second, 7 days a week,
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24 hours a day. After completing the working draft of the human genome sequence

in June of 2000, Human Genome Project scientists and computational experts began

to scour the sequence for insights. They reported the first key discoveries in the

February 15, 2001 issue of the journal Nature. Among the findings were the following:

—Humans are likely to have only 30,000 to 35,000 genes, just twice as many as

a fruit fly, and far fewer than the 80,000 to 150,000 that had been widely predicted.

—Genes are unevenly distributed across the genomic landscape; they are crowded

in some regions and spread out widely in others.

—Individual human genes are commonly able to produce several different proteins.

—More than 200 human genes arrived to the genome of some ancestor directly

from bacteria.

—The repetitive DNA sequences that make up much of our genome, and commonly regarded as ‘‘junk,’’ have been important for evolutionary flexibility, allowing genes to be shuffled and new ones to be created. The repetitive DNA

may also perform other important functions.

FINISHING THE HUMAN GENOME SEQUENCE

Because of the enormous value of DNA sequence information to researchers

around the world, in academia and industry, NHGRI has always been committed

to the principle of free, rapid access to genomic information through well-organized,

annotated databases. Databases housing the human genome sequence are being visited an average of more than 50,000 times a day. In fiscal year 2002, NHGRI will

increase the usefulness of the human genome sequence to the world’s researchers

by finishing the sequencing to match the project’s long-standing goals for completeness and stringent accuracy. More than a third of the draft sequence already has

been finished into a highly accurate form—containing no more than 1 error per

10,000 bases. Finished sequence for the entire genome is expected by 2003. Finished

sequence is already available for the entire lengths of chromosomes 21 and 22.

Genes on chromosome 21 are involved in Down syndrome, Alzheimer disease, certain cancers, and manic depressive illness, while those on chromosome 22 are implicated in the workings of the immune system, in congenital heart disease, schizophrenia, mental retardation, and several cancers, including leukemia. Researchers

can now study the molecular bases of the conditions linked to these chromosomes

systematically and comprehensively, and the same high standard of completeness

will be achieved for the other 22 human chromosomes over the next two years.

GENOME SEQUENCES OF NON-HUMAN SPECIES

In the coming year, NHGRI and its partners will sequence the genomes of important model organisms, including the mouse and rat. The Human Genome Project’s

goals always included the analysis of the genomes of species that have been important to laboratory research. Having genome sequence from additional species is one

of the most efficient tools for interpreting the human sequence, because many of the

most important elements in our genome—including genes and the regions that regulate their expression—are conserved in the genomes of other species. Genome sequences from the well-studied laboratory mouse and rat will be especially useful because, as mammals, their genomes are relatively similar to the human genome and

because they have long provided insights into the molecular basis of disease.

The Mouse Sequencing Consortium formed in October 2000 and in April 2001 produced a publicly accessible draft sequence covering 95 percent of the mouse genome,

a result of the collaborative efforts of three private companies, six institutes of the

NIH, and a British charity, the Wellcome Trust. The Consortium will now go

through the more arduous process of filling in gaps in the draft and will produce

high-quality finished sequence no later than 2005. Already, the mouse data is saving researchers a great deal of time. For example, researchers at Merck recently

found a mouse relative of a human gene implicated in schizophrenia by scanning

the newly available mouse genome sequence. Alterations in the human gene were

found in a large Scottish family where schizophrenia correlates with a chromosomal

rearrangement. Researchers had searched without success for years for the related

gene in mouse, but the mouse genome sequence readily revealed the corresponding

mouse gene in a computer search taking only seconds. The researchers can now test

the effects of inactivating the gene on the mouse brain, perhaps giving clues to the

molecular basis of schizophrenia in humans.

Meanwhile, the laboratory rat, long used for a wide range of medical research, including studies on high blood pressure, cancer, and drug metabolism, is getting its
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share of attention. In February, NHGRI and the National Heart, Lung and Blood

Institute announced a plan for sequencing the rat genome. The institutes will fund

private companies as well as academic labs; all have agreed to release data weekly

into public databases.

Other model organisms’ genomes are undergoing study as well. NHGRI is funding

scientists at the University of California at Berkeley and the Baylor College of Medicine to close the gaps in the fruit fly genome sequence and to ensure that the finished sequence meets quality standards for finished sequence data. In fiscal year

1999, NHGRI and the National Cancer Institute, leading 15 other NIH institutes,

launched the Mammalian Gene Collection, whose goals are to develop analysis tools

and to produce a collection of full-length copies of genes, which can be sent to researchers on demand. So far, nearly 20,000 full-length gene copies have been identified and are slated for sequencing.

HUMAN GENETIC VARIATION

For understanding the basis of common diseases with complex origins, like heart

disease, Alzheimer disease, and diabetes, it is important to catalog genetic variations and how they correlate with disease risk. Among any two people, an average

of one DNA spelling variation—or SNP—exists in every 1000 bases. With a draft

of the human genome sequence in hand, the pace of SNP discovery has increased

dramatically. In fiscal year 1999, NHGRI organized the DNA Polymorphism Discovery Resource consisting of 450 DNA samples collected from anonymous American

donors with diverse ethnic backgrounds. NHGRI has funded studies looking for

SNPs in these samples. The non-profit SNP Consortium came into being in April

1999, with the goal of developing a high-quality SNP map of the human genome and

of releasing the information freely. Consortium members include the Wellcome

Trust, a dozen companies (mostly pharmaceutical companies), and three academic

centers; they have looked for SNPs in DNA from a subset of the samples in the DNA

Polymorphism Discovery Resource. In July 2000, the NHGRI and The SNP Consortium announced a collaboration that has allowed the contribution of 5 times more

SNPs to the public domain than the consortium originally planned. As of March 28,

the public database that serves as a central repository for SNPs has received

2,840,707 SNP submissions.

With the increased knowledge about human variation, the genetic underpinnings

of various diseases, including diabetes, are being discovered. The recent discovery

of a gene, calpain–10, whose disruption contributes to diabetes, resulted from studies linking diabetes with genetic variations across the whole genome and then in

a specific part of chromosome 2. The newly-discovered gene suggests that a previously unknown biochemical process is involved in the regulation of blood sugar

levels. Diabetes is also one of the areas of focus for intramural research at NHGRI.

Investigators from Howard University and NHGRI are engaged in a project looking for genetic risk factors for diabetes in West Africans. This is part of a wider collaboration between the two institutions to study the genetic basis of diseases that

disproportionately affect African-Americans. The diabetes study focuses on West Africans since they are thought to be the population from which modern AfricanAmericans are largely descended, and the Africans are not exposed to the same dietary risk factors as Americans. Study recruitment centers were opened in Nigeria

and Ghana; in the fall of 2000, researchers met their goal of recruiting 400 pairs

of siblings affected with diabetes. Genetic typing of the collected tissue samples is

in progress at NHGRI’s Center for Inherited Disease Research in Baltimore to

search for genetic variations that increase susceptibility to diabetes.

Meanwhile, other intramural investigators are part of a consortium where researchers pool a wide range of data about the genetic factors underlying diabetes.

One of the studies, called FUSION (Finnish U.S. Investigation Of Non-insulin dependent diabetes mellitus) has collected DNA samples and clinical data from 5000

Finnish people who have diabetes; many of the individuals are related. A genomewide search among these people for genes related to diabetes risk has so far identified two areas on chromosome 20 that are likely to contain crucial genes.

GENE EXPRESSION

The new-found abundance of genomic information and technology is propelling scientists out of the pattern of studying individual genes and into studying thousands

at a time. Large-scale analyses of when genes are on or off (gene expression) can

be used, for example, to study the molecular changes in tumor cells. This exciting

new approach combines recombinant DNA and computer chip technologies to

produce microarrays or DNA chips. Classifying cancer on a molecular level offers

the possibility of more accurate and precise diagnosis and treatment. Intramural re-
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searchers at NHGRI have used large-scale expression studies to discover genetic signatures that can distinguish the danger from different skin cancers and that can

distinguish between hereditary and sporadic forms of breast cancer.

PROTEIN STRUCTURE, FUNCTION, AND INTERACTION

With a global view of human genes now possible, scientists are eager to obtain

a similarly comprehensive view of human proteins, a field called proteomics in analogy to genomics. Researchers want to know the functions of proteins and how the

proteins work together in cells. Only a subset of all possible proteins are present

in any given cells at any given time. To study protein function on a wide scale, various groups of researchers plan to identify the locations of proteins, their levels in

different cells, their structures, the interactions among different proteins, and how

they are modified. NHGRI is contributing to this field by developing technologies

for efficient, large-scale analyses, particularly for determining protein interactions

and measuring protein abundance in different cells.

CENTERS OF EXCELLENCE IN GENOMIC SCIENCE

In fiscal year 2001, NHGRI will award the first grants under a new program to

bring cross-disciplinary teams of researchers together with shared resources and a

unified goal. The Centers of Excellence in Genomic Science are designed to develop

new genomic approaches for analyzing the molecules of life systematically, to integrate technical developments into biomedical research, and to expand training opportunities. Additional centers will be funded in fiscal year 2002 to develop new

ways of undertaking genome-wide analyses in areas like the regulation of gene expression, protein expression and interaction, human genetic variation, and the storage and analysis of the flood of new data. These centers are expected to be a source

of creative approaches addressing previously unanticipated questions. As training

centers, they will give high priority to the training of people from racial or ethnic

minority groups, women, and people with disabilities.

PROMISE FOR NEW TREATMENTS AND PREVENTION

Genetic testing will become increasingly important for assessing individual risk

of disease and prompting programs of prevention. An example of how this may work

involves the disease hereditary hemochromatosis (HH), a disorder of iron metabolism affecting about one in 200 to 400 Americans. Those with the condition accumulate too much iron in their bodies, leading to problems like heart and liver disease

and diabetes. The gene causing the condition has been identified, allowing early

identification of those in whom HH may develop. Once people at risk are identified,

they can easily be treated by periodically removing some blood.

Genetic testing is also being used to tailor medicines to fit individual genetic profiles, since drugs that are effective in some people are less effective in others and,

in some, cause severe side effects. These differences in drug response are largely genetically determined. Customizing medicine to a patient’s likely response is a promising new field known as pharmacogenomics. A recent publication in the journal Hypertension showed how pharmacogenomics applies to high blood pressure. Researchers found a variation in a particular gene that affects how patients respond to a

commonly used high blood pressure drug, hydrochlorothiazide. Other recent studies

reveal that doctors should avoid using high doses of a common chemotherapy treatment (6-mercaptopurine) in a small proportion of children with leukemia. Children

with a particular form of a gene (TPMT) suffer serious, sometimes fatal, side effects

from the drug.

Genomics is also fueling the development of new medicines. Several drugs now

showing promising results in clinical trials grew out of genomics-related studies.

One example is Glivec (previously called STI571), produced by Novartis for treating

chronic myelogenous leukemia (CML). In CML, an abnormal gene fusion creates an

abnormally activated protein. Novartis designed a small molecule that specifically

inactivates the protein. In phase I clinical trials, this drug caused favorable responses in 53 of 54 patients, while side effects were minimal no matter how high

the dosage. Meanwhile, Bayer and Millennium announced the development of another cancer drug born of genomics in January 2001. GlaxoSmithKline is testing a

new genomics-derived heart disease drug that targets a protein involved in fat metabolism. Johnson & Johnson is testing a drug targeting a brain receptor involved

with memory and attention. Human Genome Sciences has four clinical trials in

progress to test gene-based drug candidates.
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ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS

From its inception, NHGRI recognized its responsibility to address the broader

implications of having access to genetic information and technology. Since 1991, it

has committed 5 percent of its budget to studying the ethical, legal, and social implications (ELSI) of genome research. Study of human genetic variations raises many

ELSI issues. The case of hemochromatosis brings up some of these issues. Given the

devastating complications from HH and the simple treatment, some have proposed

widespread genetic testing to find those predisposed to HH. But considerable uncertainty remains about how strong the link is between particular gene variants and

the presence and severity of HH disease. In fiscal year 2000, NHGRI and the National Heart, Lung and Blood Institute began a 5-year, $30 million epidemiological

study among 100,000 adults to gauge, among other things, the prevalence and the

genetic and environmental causes of HH. NHGRI is funding an examination of the

ethical, legal, and social issues related to implementing a widespread screening program. Information from the study should yield insights not only for HH but also for

other treatable adult-onset genetic disorders.

Many ELSI issues raise policy implications; one is how to deal with potential employment discrimination. Two years ago, a Time/CNN poll showed that 95 percent

of those polled thought employers should not have access to genetic information

about employees without their permission. A recent case, involving the BurlingtonNorthern Santa Fe railroad, shows what can happen. In March 2000, BNSF added

testing for a gene (PMP22), which may be the cause of carpal tunnel syndrome in

a small population of people with the disorder, to the medical evaluation of employees who file workers’ compensation claims for carpal tunnel syndrome, to test

whether the carpal tunnel syndrome was ‘‘work-related.’’ Employees were not told

that their blood would be submitted for a genetic test. In February, the Equal Employment Opportunity Commission and the workers’ union filed suit against BNSF.

The company has now stopped genetic testing and agreed to seek approval from the

union before doing any genetic testing in the future. While this is a happy ending

for this particular case, comprehensive public policy will be required as genetic tools

become more widespread. The ELSI program at NHGRI will continue to form policy

recommendations that balance the need to protect individuals with the needs of the

research community and the healthcare industry.

Finally, as part of its mission of education, NHGRI produced a free educational

kit, ‘‘The Human Genome Project: Exploring our Molecular Selves,’’ that was released when the human sequence analysis was published in February. The kit includes a multimedia CD–ROM, an award-winning video documentary, and an informational brochure. The kit is designed to give science teachers and classrooms, particularly at the high school level, better access to the latest information about genome science and its implications, but it is expected to be used more broadly, by

college students, voluntary health organizations, and the general public. Backing

from Howard Hughes Medical Institute and Pharmaceutical Research and Manufacturers of America (PhRMA) insured that the kit, sponsored by the NIH and DOE,

would be available for free. Nearly 40,000 kits have been requested in just two

months.

I am pleased to present the President’s budget request for the National Human Genome Research Institute (NHGRI) for fiscal year 2002, a sum of $426,739,000,

which reflects an increase of $44,627,000 over the comparable fiscal year 2001 appropriation. The NIH budget request includes the performance information required

by the Government Performance and Results Act (GPRA) of 1993. Prominent in the

performance data is NIH’s second annual performance report which compares our

fiscal year 2000 results to the goals in our fiscal year 2000 performance plan. As

performance trends on research outcomes emerge, the GPRA data will help NIH to

identify strategies and objectives to continuously improve its programs.

PREPARED STATEMENT OF DONNA J. DEAN, PH.D., ACTING DIRECTOR, NATIONAL

INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Biomedical Imaging and Bioengineering (NIBIB) for fiscal year 2002, a sum of $40,206,000, which reflects an

increase of $38,231,000 over the comparable fiscal year 2001 appropriation.

At the outset, I should note that the NIBIB is the newest of NIH’s Institutes, having been established on December 29, 2000 by Public Law 106–580, the National

Institute of Biomedical Imaging and Bioengineering Establishment Act of 2000. I

am excited by the challenge afforded me to help guide the formation and early development of this newest member of the NIH family. In the past four months, we
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have begun to consider the new opportunities in biomedical research that NIBIB

can foster and have articulated the basic principles upon which we will build NIBIB.

It is my privilege to share with you the philosophy under which the NIBIB will operate and our initial steps toward fulfilling the promises embodied in the legislation.

A MISSION OF PROMISE

The foundations of tomorrow’s medicine will continue to be built on the emergence

of discoveries in basic science and development of new technologies. The mission of

NIBIB is to apply the principles of engineering and imaging science to biological

systems. Advances in the imaging sciences could change the face of medicine, making it possible to non-invasively detect, diagnose, and guide therapy for a large variety of diseases. Bioengineering is unique in its ability to integrate principles from

diverse fields, and to cross the boundaries of academia, science, medicine and industry. The focus of NIBIB will be on developing fundamental new knowledge, creating

potent new technologies, and nurturing researchers to be able to fully integrate the

quantitative sciences with biomedical research.

Bioengineering and the imaging sciences are rooted in physics, mathematics,

chemistry, materials sciences, computer sciences and the life sciences. The application of these systematic, quantitative, and integrative ways of thinking about and

approaching the solutions to problems will be important to biology and medical research. The biological scientist often seeks to answer such questions as ‘‘Why do

things work the way they do?’’ and ‘‘How do these organisms function?’’ The engineer or imaging scientist may ask questions such as ‘‘How can I create something

that has never existed before?’’ or ‘‘Can I develop a solution to this seemingly intractable problem?’’ The excitement of bringing together new research constituencies,

perspectives and collaborations is a particular challenge and a unique opportunity

for NIBIB.

In support of its mission, NIBIB will support an integrated and coordinated program of research and research training that can be applied to a broad spectrum of

biological processes, disorders and diseases and across multiple organ systems.

Strong coordination will be fostered with biomedical imaging and bioengineering

programs of other NIH Institutes and other agencies so as to support imaging and

engineering research with potential medical applications. These partnerships will

facilitate the translation of fundamental discoveries into research on and applications for specific diseases, disorders, or biological processes.

Most of the revolutionary changes in biology and medicine over the past decades

were rooted in fundamental discoveries in many different fields, such as the role of

nuclear physics in producing radioisotopes essential for much of modern medical

science. Engineering and physics were central in the development of key tools of

common clinical practice today—x-rays, computed tomography (CT) scanning, fiber

optic viewing, laser surgery, echocardiography and fetal sonograms. Materials

science is helping to develop new joints, heart valves, and other tissue mimetics.

Understanding of nuclear magnetic resonance and positron emissions was required

for the imaging study of the location and timing of brain activities that accompany

thought, motion, sensation, speech, or drug use. Now, as never before, the boundaries are disappearing between biology and biomedical engineering, resulting in increasing and expanding opportunities for new scientific and technological approaches and new clinical tools and devices.

IDENTIFYING PRODUCTIVE NEW RESEARCH DIRECTIONS

The creation of programs on the cutting edge of research and innovation will pose

complex scientific challenges and require multidisciplinary strategies. A critical component of the Institute’s inaugural year will be the formulation of a strategic plan

for research in biomedical imaging and bioengineering. This activity will be undertaken in cooperation with the NIBIB Advisory Council and with broad representation from the research community. An outstanding opportunity exists to recruit scientists, engineers and physicians to new areas of biomedical research through the

research programs to be developed by NIBIB.

NIH has provided important groundwork that is of invaluable aid to NIBIB as it

formulates an emerging research agenda. Key areas of future research in biomedical

imaging and bioengineering have been highlighted by four symposia sponsored by

NIH in the last three and a half years. At these meetings, the country’s leading engineers, scientists, and physician-scientists have addressed areas of opportunity in

bioengineering, biomedical imaging, nanotechnology, and reparative medicine or tissue engineering.

Since one of NIH’s highest priorities is the funding of medical research through

research project grants, NIBIB will emphasize this mechanism to promote funda-
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mental discoveries, design and development, and translation of technological capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics, materials science, and computer

sciences. The research supported by NIBIB will be multidisciplinary in nature and

strongly synergistic with NIH’s other research Institutes and Centers. NIBIB will

expand the principles embodied in NIH’s development of the Bioengineering Research Partnerships and Bioengineering Research Grants—that creation, development, and implementation of technology are worthy goals.

DEVELOPING A NEW GENERATION OF RESEARCHERS

NIBIB will meet the challenge of training a new generation of investigators with

a vision transcending narrow disciplines. Training and career development programs will be central to NIBIB’s approach to its mission. Increasing the pool of individuals uniquely positioned to bring innovative concepts and approaches to research

in biomedicine and health will benefit the entire NIH. The changing nature of biomedical research in the future points strongly toward the need to train our young

physicians and engineers to succeed in facets of biomedical research that are not

yet imagined.

CONCLUSION

NIBIB’s leadership in developing crosscutting research and training in biomedical

imaging and bioengineering will be fostered by strong partnerships and collaborations with other Institutes and Centers of NIH, all with the ultimate goal of improvement in human health and well-being. NIBIB is poised to identify challenges

in biomedical research that can benefit from bioengineering approaches, facilitate

interinstitute cooperation, and promote transdisciplinary training. NIBIB will

strengthen and complement, not substitute for or subtract from, the already robust

research programs of NIH’s other Institutes and Centers. We look forward to the

challenges of the next year in creating a new and enriched focus at NIH for bioengineering and imaging sciences.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

The budget request for fiscal year 2002 for the National Institute of Biomedical

Imaging and Bioengineering is $40.2 million.

Mr. Chairman, I will be happy to answer your questions.

PREPARED STATEMENT OF ANTHONY S. FAUCI

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Allergy and Infectious Diseases

(NIAID) for fiscal year (FY) 2002. Including the estimated allocation for the acquired immunodeficiency syndrome (AIDS) of $1,192,855,000, total support requested for NIAID is $2,355,325,000, an increase of $292,317,000 over the fiscal

year 2001 appropriation. The portion of the budget not related to AIDS is

$1,162,470,000, which reflects an increase of $162,054,000 over the comparable fiscal year 2001 appropriation. The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of

1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal year 2000 results to the goals in our fiscal year 2000

performance plan. As performance trends on research outcomes emerge, the GPRA

data will help NIH to identify strategies and objectives to continuously improve its

programs.

OVERVIEW OF NIAID

NIAID, the third largest NIH Institute, supports and conducts research to better

understand, treat and prevent infectious, immunologic, and allergic diseases. The

scope of the NIAID research portfolio is expanding continually in response to new

challenges, such as the emergence of AIDS and other newly recognized diseases, and

because of scientific opportunities facilitated by new technologies and progress in

the core NIAID scientific disciplines of microbiology, immunology, and infectious diseases. Advances in these key fields, including progress in relatively new areas such

as pathogen and human genomics, are driving the development of new treatments,
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vaccines, diagnostic tests, and technologies that improve the health of people in the

United States and around the world.

In order to meet the many health challenges of the new millennium and take advantage of unprecedented scientific opportunities, the Institute has developed a strategic research plan for the 21st century centered around four major areas: (1) Global

health and emerging infectious diseases; (2) HIV/AIDS; (3) Immune-mediated diseases, including allergy and asthma; and (4) Vaccines. The complete NIAID Strategic Plan is available on the World Wide Web at http://www.niaid.nih.gov/

strategicplan2000.

GLOBAL HEALTH AND EMERGING INFECTIOUS DISEASES

NIAID has a long history of supporting research into diseases that transcend national boundaries and hence fall under the rubric of global health. Examples of such

diseases include newly recognized conditions such as AIDS and liver disease due to

hepatitis C virus; diseases that have spread to new geographical settings, such as

West Nile fever and dengue; and resurgent endemic diseases such as malaria and

tuberculosis, which are increasingly resistant to antimicrobial drugs. In addition, we

now face the specter of a new kind of emerging disease: one deliberately spread by

bioterrorists. These emerging and re-emerging diseases are superimposed on other

major health problems such as acute respiratory infections, diarrheal diseases, and

measles, which remain leading causes of illness and death worldwide.

To mitigate the burden of these diseases, NIAID supports numerous laboratory,

field-based, and clinical research projects related to global health, both domestically

and abroad. Among many projects, NIAID-supported studies on malaria in Mali,

pneumococcal disease in the Gambia, tropical diseases in the International Centers

for Tropical Disease Research, and HIV prevention through the HIV Prevention

Trials Network, have achieved important results through coordinated partnerships

with local governments and other agencies and organizations. Building on NIAID’s

longstanding commitment in global health, the Institute this month released a new

‘‘Global Health Research Plan for HIV/AIDS, Malaria, and Tuberculosis’’, which outlines NIAID goals and plans for fighting infectious diseases by building sustained

research capability domestically and internationally and enhancing international

partnerships.

Many of the challenges posed by emerging infectious diseases lend themselves to

research in a relatively new field: genomics. The sequencing of the entire human

genome and the anticipated assignment, over the next few years, of function to the

estimated 30,000 to 60,000 human genes will have an enormous impact on all of

medicine, including our understanding of the host response to microbial pathogens.

In addition, the genomic sequencing of microbial pathogens will be a critical component of 21st century strategies for the development of diagnostics, therapeutics, and

vaccines for infectious diseases. NIAID has funded projects to sequence the genomes

of more than 50 medically important pathogens, a dozen of which have been completed. These include the bacteria that cause tuberculosis, gonorrhea, chlamydia,

and cholera, as well as individual chromosomes of the malaria parasite, Plasmodium falciparum. Most recently, investigators have reported the complete genomic

sequence of Streptococcus pyogenes, a bacterium that causes diseases ranging from

strep throat to the flesh eating disease known as necrotizing fasciitis, as well as

that of Escherichia coli O157:H7, a worldwide public health threat that has triggered scores of recent outbreaks of hemorrhagic colitis and numerous fatalities from

kidney failure. In the interest of global scientific cooperation, NIAID-supported scientists deposit pathogen sequence data in specialized public databases such as

GenBank, where investigators around the world can access it via the World Wide

Web.

HIV/AIDS

AIDS, caused by the human immunodeficiency virus (HIV), has claimed 22 million

lives since the disease was recognized 20 years ago. More than 36 million people

are living with HIV infection, including approximately 800,000 to 900,000 individuals in the United States. In the United States and other western countries, potent

combinations of anti-HIV drugs (highly active antiretroviral therapy or ‘‘HAART’’)

have dramatically reduced the numbers of new AIDS cases and AIDS deaths.

NIAID-supported investigators conducted research that was pivotal to the development of these drugs, and have helped define how best to use these medications in

different clinical settings. Ongoing research promises to yield a new generation of

drugs that may improve upon existing medications in terms of cost, effectiveness,

and tolerability.
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Until recently, expensive HAART regimens were considered to be beyond the

reach of developing countries, where 95 percent of the world’s HIV-infected people

live. Now, with dramatic reductions in the price of antiretroviral drugs for developing nations and the commitment of world leaders to address the AIDS problem

in southern Africa and other poor regions of the world, AIDS therapies will begin

to reach more of the people in poor countries who could benefit from them. Building

on the research infrastructure that NIAID has helped establish in Africa and elsewhere in the developing world, we intend to work with our international colleagues

to link the provision of anti-HIV therapy to ongoing efforts in prevention research,

with the goal of facilitating a comprehensive approach to the AIDS pandemic in poor

countries. Two recently launched NIAID programs will be key to this effort: the HIV

Prevention Trials Network (HPTN) and the HIV Vaccine Trials Network (HVTN),

which have research sites in the United States, Latin America, Europe, Africa, Asia

and the Caribbean.

The HPTN focuses on several key areas of prevention research, including behavioral modification, interventions to prevent mother-to infant transmission of HIV,

and the development of topically applied microbicides that women could use to protect themselves against HIV and other sexually transmitted pathogens. The HVTN

will conduct all phases of clinical vaccine trials, from evaluating candidate vaccines

for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

In pre-clinical and clinical studies, NIAID-supported investigators are testing a diverse range of vaccine strategies, several of which in recent months have shown remarkable promise in tests in non-human primates. The best candidates will be

moved rapidly into HVTN trials. We remain optimistic that a safe and effective vaccine can be found that will prevent HIV infection and/or slow the progression of disease in people who are already infected with the virus.

IMMUNE-MEDIATED DISEASES

Immunologic diseases cause a considerable burden of illness and death and lead

to medical costs that exceed $100 billion annually in the United States. Many immune-mediated diseases disproportionately affect women and members of minority

groups. Autoimmune diseases such as type-one diabetes, rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis collectively afflict approximately

five per cent of the U.S. population. More than seven percent of American children

are asthmatic, with poor children in inner city areas disproportionately affected by

this serious disease. In addition, immune-mediated graft rejection remains a significant obstacle to the successful transplantation of potentially life-saving organs.

NIAID-funded research in basic and clinical immunology has led to many promising approaches for treating individuals with these and other immunologic conditions. For example, researchers are developing novel ways of selectively blocking inappropriate or destructive immune responses, while leaving protective immune responses intact. This approach, called tolerance induction, holds great promise for the

treatment of many immune-mediated conditions, including autoimmune diseases

and asthma and allergic diseases. The induction of tolerance to transplanted organs

or tissues ultimately may allow transplant patients to forego long-term regimens of

broadly immunosuppressive drugs. These drug regimens are costly and dampen not

only destructive immune responses, but protective ones as well, thereby increasing

a patient’s risk of malignancies and infections. Among many projects in the field of

immune tolerance, the Institute established the Immune Tolerance Network (ITN),

an international consortium of more than 70 research groups. The ITN is implementing clinical trials in four areas: transplantation of islets (the insulin-producing

cells of the pancreas), kidney transplantation, autoimmune diseases, and asthma

and allergic diseases. The first ITN trial is testing a new approach to transplanting

islets in diabetics who are unable to properly control their blood sugar levels. This

international study builds on groundbreaking research at the University of Alberta

that has resulted in long-term insulin independence for nearly 20 patients.

For more than a decade, NIAID has worked to reduce the burden of asthma, particularly among inner-city children. Investigators of NIAID’s National Cooperative

Inner-City Asthma Study developed a successful behavioral and educational intervention that substantially reduced asthma severity in these pediatric populations.

Building on this success, NIAID and the Centers for Disease Control and Prevention

(CDC) are collaborating to implement this proven intervention in a new four-year

program that will reach 6,000 children in 23 inner-city health care delivery sites

throughout the U.S. An ongoing NIAID intervention study, involving approximately

1,000 children nationwide, is testing the effectiveness of environmental control

measures and physician education in reducing the burden of asthma. Preliminary

results are showing substantial reductions in asthma symptoms and emergency
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room visits. In both of these studies, recruitment has exceeded the targeted levels

and retention of patients has been extraordinarily high compared to other studies

of other inner-city pediatric populations. Because of these successes, NIAID-supported inner-city asthma programs are now recognized as models for conducting

clinical research in the inner city and have attracted partners in the public and private sectors to collaborate with NIH-funded researchers. These collaborations promise to bring new asthma interventions to minority populations whose access to such

therapies might otherwise be diminished or delayed.

VACCINE DEVELOPMENT

Vaccination has been recognized as the greatest public health achievement of the

20th century, and vaccine research has long been a cornerstone of the NIAID research portfolio. NIAID-supported research has led to the development of many new

and improved vaccines now widely used, such as those against Haemophilus

influenzae type b, pertussis, chickenpox, pneumococcal disease, and hepatitis A and

B. The rapidly evolving science base in pathogen genomics, immunology and microbiology will facilitate further progress in developing new and improved vaccines. In

particular, the availability of the genomic sequences of major microbial pathogens

will facilitate the identification of a wide array of new antigens for vaccines. Because many pathogens gain entry to the body via mucosal sites, NIAID-supported

scientists are developing new vaccines that target mucosal surfaces such as those

in the intestine or respiratory tract. Vaccines that are easy to administer—orally,

nasally, or trans-dermally—will have great utility in resource-poor setting and for

mass immunization programs. In addition to the development of vaccines against

classic infectious diseases, NIAID is working to develop vaccines against chronic diseases with infectious origins, as well as potential agents of bioterrorism, and autoimmune diseases and other immune-mediated conditions.

CONCLUSION

In the 21st century, NIAID is poised to exploit unprecedented scientific opportunities in immunology, microbiology and infectious diseases. As has been the case for

more than 50 years, a commitment to the best possible research—basic science as

well as clinical trials—will drive our efforts to improve health in this country and

abroad. With a strong research base, the commitment of talented investigators, and

the availability of powerful new research tools, we are confident that our initiatives

will help solve seemingly intractable clinical and public health problems and improve global health in the 21st century.

PREPARED STATEMENT OF STEPHEN A. FICCA, ASSOCIATE DIRECTOR FOR RESEARCH

SERVICES

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the Buildings and Facilities (B&F) Program for fiscal year

2002, a sum of $306,600,000, which reflects an increase of $152,810,000 over the

comparable fiscal year 2001 appropriation.

ROLE IN THE RESEARCH MISSION

The annual Buildings and Facilities (B&F) Appropriation is the only means by

which the public supports the crucial physical infrastructure required to carry out

the in-house component of the biomedical research mission of the National Institutes of Health (NIH). As approaches to basic and clinical research evolve, the demands for, and on, research facilities change as well. Properly planned and

equipped, safe, and flexible research facilities are important resources in the formula for achieving the next scientific advance or biomedical breakthrough.

The fiscal year 2002 Buildings and Facilities budget request is the product of a

deliberate, corporate facilities planning process that addresses the NIH’s immediate

and longer range facility requirements of the entire agency. The goal of the planning

process is to optimally meet the changing facility needs of the NIH research programs in the Washington, D.C., region and across the NIH field stations with a mix

of owned and leased facilities.

The B&F appropriation funds a continuing, multi-year program that supports

NIH facilities throughout their life-cycles. The construction program supported by

the proposed fiscal year 2002 request strikes a balance among three critical facility

priorities: the creation of new facilities for new and expanding scientific opportunities, the upgrading of existing facilities to keep pace with the changing requirements of ongoing NIH programs, and the responsible stewardship of the entire NIH
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real estate portfolio. The specific projects included in the proposed fiscal year 2002

request are on the critical path of a larger rolling five-year plan. Thus, the investments in fiscal year 2002 are predicated on previous investments and the timely investment in the future. For example, the Building 6 modernization is the last

project in a series of projects that began in the 1980’s to renovate the original NIH

research buildings. The upgrade of the mechanical system at the National Institute

of Environmental Health Sciences is the first phase of a two-phase modernization

of the mechanical and electrical systems at the Research Triangle, North Carolina,

field station.

Safe, modern facilities, including the appropriate building systems and utility infrastructure, are a basic requirement to effectively carry out NIH’s intramural research program, as well as stewardship of the extramural research programs. For

the intramural research program, they are necessary to enable NIH’s expansion into

new areas of investigation, to house an expanding cadre of researchers and trainees,

to attract the best and the brightest investigators, and to help retain staff who are

being courted by the burgeoning biomedical industry.

The B&F request for each budget year strives to optimize the distribution of resources among the programs activities so that, year to year, the continuity of the

individual projects and the B&F Program as a whole is maintained.. Within this

balanced mix of new construction, essential safety and health improvements, repair

and improvement projects, renovations, and equipment and system upgrades, three

projects are particularly important to the NIH’s research plans: the John Edward

Porter Neuroscience Research Center, the Central Vivarium/Animal Research Center, and the Building 10 Revitalization Program.

The John Edward Porter Neuroscience Research Center will enable the integration of the neuroscience research community at the NIH. The Center is conceived

as a place where the best and brightest scientists from many disciplines will collaborate in state-of-the-art laboratories to develop and evaluate therapies for some of the

most complex problems in biomedical research. The Center will house researchers

from nine institutes and multiple disciplines under one roof. It will be designed to

support high priority research initiatives using innovative strategies in cell biology,

neuroimaging and bio-informatics to better describe the link between biochemistry

and behavior, to elucidate the nerve cell degenerative processes, and to explore

other lines of inquiry that are emerging from the genetic mapping of the brain.

New facilities are needed to support this vision because nearly all of the space

that houses NIH neuroscience research is substandard. Current facilities for cellular

and molecular neuroscience on campus are inadequate to meet the challenges of

high-quality, high-risk research projects.

The Central Vivarium/Animal Research Center is a vital part of the NIH research

infrastructure. Animal models continue to be one of the most valuable means of elucidating basic biology and more complex mechanisms of disease. The multi-level facility will include state-of-the-art animal holding, receiving and quarantine areas;

procedures and specialized laboratories and administrative support spaces. It will

replace facilities that are crowded and only marginally suitable to the support of

many of the most promising animal models with AAALAC-compliant facilities specifically designed to humanely house non-mammalian species, genetically altered rodents, chimeras, and non-human primates.

The soon to be completed Mark O. Hatfield Clinical Research Center (CRC) will

be one major milestone in a continuing effort to maintain the physical research infrastructure of the Agency. It will house state-of-the-art patient-related research and

laboratory research facilities for the clinical programs. The Building 10 Revitalization Program is the next phase in the renaissance of the critical infrastructure for

the clinical research program at the NIH described in the 1994 Marks-Cassell report. The Building 10 Revitalization Program is a multi-phased approach that will

renovate and renew the portions of the clinical program that remain in Building 10

when the CRC is occupied. The purpose of this effort when completed, is to accommodate all the research programs in the entire Clinical Center Complex in modern,

safe, state-of-the-art hospital, research and support facilities. The fiscal year 2002

request for the Building 10 Revitalization Program consists of three program activities. The Building 10 Transition Program includes projects required to sustain

functionality between the old and new buildings. The Building 10 Interim Renovation provides the necessary space and infrastructure reconfiguration to allow continued operation of the building during the phased renewal. Finally, the Phase I Renovation of Building 10 includes the renovation of the central core as clinical research

space and the renovation and interconnections of the hospital and facilities support

systems between the buildings.
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1 Updated figures from Lewin Group, 1998.

2 IAAA epidemiology data.

FISCAL YEAR 2002 BUDGET SUMMARY

As in prior and future years, the funding request for fiscal year 2002 is a part

of a long range plan. The fiscal year 2002 request for Buildings and Facilities is

$306.6 million. The B&F request totals $105.1 million for new construction composed of $26 million for the continued construction of the John E. Porter Neuroscience Research Center; $10.6 million to fund the design of the second phase of the

Center; $53 million to complete the design and start the construction of the Central

Vivarium/Animal Research Center; $14 million to design and construct the Northwest Parking Facility; and $1.5 million to initiate the Concept Development Studies

program. There is a total of $99.9 million for essential safety and health improvements composed of a combined sum of $36 million to begin the Building 10 Revitalization Program through a plan of Interim Renovations to provide temporary space,

and the initiation of the Phase I Renovation; $19.7 million in funding to complete

the modernization of Building 6; $10 million for the continued support of the rehabilitation of animal research facilities; $10 million for the continuing upgrade of fire

and life safety deficiencies of NIH buildings; $3 million for the phased removal of

asbestos from NIH buildings; $1 million to systematically remove existing barriers,

to persons with disabilities, from the interior of NIH buildings; $2 million to address

indoor air quality concerns and requirements at NIH facilities; $12.2 million as a

second phase to improve and upgrade utilities at the NIH Animal Center; $7.2 million to replace the mechanical systems in Building 6B; $5 million to initiate a fouryear program to upgrade elevators in various buildings on the Bethesda and satellite campuses; and $1 million to allow for environmental remediation activities at

NIH sites. In addition, the fiscal year 2002 request includes $65 million for the continuing program of repairs, improvements, and maintenance that is the core of the

B&F program. The fiscal year 2002 request also includes: $14.1 million for the

Building 10 transition program; $3.6 million to upgrade mechanical systems at

NIEHS; and $11.7 million to complete the construction and installation of Boiler 7

on the NIH campus in Bethesda.

GOVERNMENT PERFORMANCE AND RESULTS ACT (GPRA)

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

My colleagues and I will be happy to respond to any questions you may have.

PREPARED STATEMENT OF ENOCH GORDIS, M.D. DIRECTOR, NATIONAL INSTITUTE ON

ALCOHOL ABUSE AND ALCOHOLISM

I am pleased to present the President’s budget request for the National Institute

on Alcohol Abuse and Alcoholism (NIAAA) for fiscal year 2002, a sum of

$381,966,000, which reflects an increase of $41,288,000 over the comparable fiscal

year 2001 appropriation.

Alcohol-use disorders impose an enormous toll on society. They cost the Nation $185 billion each year, one-and-one-half times as much as all illegal drugs combined,1 and 100,000 people die of alcohol-related causes annually.2 These figures reflect only the toll imposed by the 14 million adult Americans who are physically dependent on alcohol or who abuse it to the point that it disrupts their lives, but who

aren’t dependent on it.2 Still others add to the burden when they occasionally drink

to excess and, temporarily impaired, injure or kill themselves or others, or damage

property.

ALCOHOL IS UNIQUE

Among substances of abuse, alcohol is unique in a number of ways. It is a toxin

that can cause damage to any tissue in the body. The resulting diseases range from

certain kinds of cancer to liver and heart disease. Alcohol also is unique in the pervasiveness of its actions in the nervous system, the body’s command center, through

which alcohol exerts its behavioral effects. Rather than affecting only one or a few

neurotransmitter systems—that is, the crucial chemical systems through which

components of the nervous system communicate with each other and with the out-
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side world—alcohol affects every neurotransmitter system that we have studied to

date.

Alcohol also affects parts of the membrane that surrounds nerve cells, the ‘‘point

of entry’’ for substances of abuse, that illegal drugs do not appear to affect. These

factors greatly complicate the search for alcohol’s sites of action in the nervous system.

Policy and legal issues—as well as social ones—also confer unique status on alcohol. For example, alcohol raises the need for laws on minimum drinking age, maximum allowable blood levels for driving, and zoning and licensing. Alcohol raises the

issue of revenue, since it is associated with a tax-paying industry, an industry that

promotes alcohol’s use through advertising. Alcohol also raises the issue of warning

labels on beverage containers.

Another of the ways in which alcohol is unique among substances of abuse is that

it is a food, since it has caloric value. The brain regulates appetite for food through

neuropeptides, pieces of protein. Evidence suggests that, to some extent, craving for

alcohol might be driven by the same or similar biochemical pathways that drive appetite for food.

NEUROSCIENCE HOLDS THE KEY TO BEHAVIORS OF ALCOHOLISM

Some people can drink lightly and occasionally and never develop problems with

alcohol, while at the opposite end of the spectrum of alcohol use, it takes over people’s lives and they become physically dependent on it. Between these two scenarios

lie varying degrees of use and misuse. What accounts for these differences in how

people respond to alcohol, differences that may decide whether or not it destroys

their lives?

Environmental factors—family and peers, for example—play a role, but variations

in our nervous systems constitute the largest part of the differences in our behaviors

toward alcohol. It is here that alcohol affects a multitude of biologic events that determine our propensity for drinking and our vulnerability to the biologic process of

becoming dependent on alcohol. Before we have taken our first drink, the genetic

and molecular make-up of our brains influences, largely, how we will respond to alcohol once we are exposed to it.

Substances ultimately stimulate the same major reward pathways of the brain.

However, various substances first stimulate other, different biochemical pathways

before they ‘‘light up’’ these major reward pathways. Thus, substances differ in the

mechanisms, and in the complexity of those mechanisms, that lead to reward. The

routes of alcohol’s actions appear to be particularly pervasive.

Alcohol’s effects on the nervous system vary throughout the life-span, from the

uniquely devastating damage it causes in the fetus, to disruptions in development

of the adolescent brain, to the patterns of biologic risk and damage we see in adults.

Among substances of abuse, alcohol is, by far, the greatest inducer of neurologic and

other birth defects.

THE ANSWERS WE SEEK

Alcohol research seeks to answer these questions: What are the genetic and molecular factors in the brain that determine these differences in how we respond to

alcohol? How does alcohol change ‘‘hardwired’’ functions of the brain to cause physical dependence? What role do environmental factors play in alcohol dependence?

Can we design interventions that disrupt these biologic and environmental pathways, to prevent alcohol’s harmful effects? In each of these areas and others, we are

making advances.

ADVANCES IN ALCOHOL RESEARCH

Our neuroscience research is aimed at understanding how a multitude of biologic

factors combine to form neural circuits—networks of nerve cells and the thousands

of biochemical activities associated with them—that mediate alcohol’s actions. Our

research links these biologic events with alcohol-related behaviors and the impact

that environmental influences have on them.

We have made major advances. For example, we are closing in on specific regions

of the nerve-cell membrane where alcohol initiates its effects. This kind of information raises possibilities for design of medications that block such sites. Among our

priorities is to develop medications that will be effective in a wider range of people

with alcoholism than are current medications. For example, our research on a nervous-system protein (protein kinase Cε) has resulted in a treatment-development

project by a pharmaceutical company.

Animal and clinical neuroscience findings are guiding our efforts to develop medications for alcoholism that target optimal molecular sites in the nervous system. For
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example, naltrexone, approved for alcoholism treatment by the FDA in recent years,

targets a specific neurotransmitter system—the opioid system—and is among the

more promising pharmaceuticals currently in use.

In the genetics arena, we have found several chromosomal regions likely to contain genes that influence our susceptibility to alcoholism. Our challenge is to pinpoint their exact locations. Because alcoholism is a genetically complex disease—

that is, multiple genes influence it—the search for these genes is complex. Our Collaborative Study on the Genetics of Alcoholism addresses this issue and has generated data used by other disciplines with an interest in addiction and by the scientific community.

We are conducting studies in rodents in which we either ‘‘knock out’’ or enhance

the activities of genes, to see how this affects behaviors toward alcohol. These studies are providing us with information about biologic mechanisms that contribute to

the risk of becoming alcoholic. Another genetics technology (microarray technology)

is telling us which genes appear to be active under various scenarios of alcohol use.

This technology enables us to scan much of the human genome for changes in gene

activity that occur with physiologic states associated with alcohol; for example, alcohol dependence.

Our research is revealing mechanisms that mediate alcohol’s damage to the fetus

and evidence that adolescent brains are vulnerable to alcohol-induced damage. New

NIAAA research also links stress-induced hormonal changes in infancy with risk of

alcohol problems later in life.

Ultimately, these kinds of studies can guide us to points for pharmaceutical intervention in the biochemical pathways through which alcohol exerts its effects. We are

capturing the potential of neuroscience through collaboration. Alcohol research covers the spectrum from genetics to behavior and all of the intricate molecular biology

that lies between. However, so many areas of expertise now exist in neuroscience

that integrating research and results relevant to alcohol investigations is difficult.

To ensure that we do not miss opportunities, our Integrative Neuroscience Initiative

on Alcoholism is encouraging investigators from different fields to integrate their

work and their findings. We expect this major initiative to speed the translation of

new findings into clinically useful data.

BEYOND BASIC SCIENCE

Our research on social and policy issues extend far beyond questions of legislation.

For example, drinking among college students is a complex problem entrenched in

campuses and communities. Evidence suggests that intentional and unintentional

injury, including death, associated with this problem is much greater than previously suspected. Our investigators are pursuing estimates of alcohol-related death

rates among this vulnerable age group, and avenues for prevention. Minority groups

provide another example. Certain minority groups appear to respond differently to

alcohol, physically and behaviorally, than does the general population. Our epidemiology research identifies these kinds of public-health issues, and these findings lead

to basic and behavioral research that investigates root causes and potential interventions.

We bring our research findings to the public in a variety of ways. Our Research

to Practice Initiative is an excellent example. In collaboration with the Substance

Abuse and Mental Health Services Administration’s Center for Substance Abuse

Treatment, we arrange with States to meet with treatment providers and administrators. After exchanging information about our current research findings and the

practitioners’ obstacles to providing treatment, we place experts in temporary

residencies in treatment programs that have identified specific areas of need.

We bring our findings to the public via Alcohol Screening Day, a nationwide event

that enables people to receive free screening for alcohol problems and, if needed, referrals. Last year, almost 1,500 sites across the country participated, more than 370

of them college campuses. We also are dealing with the difficult issue of college

drinking through our Advisory Council’s Subcommittee on College Drinking. The

Subcommittee, a collaboration between researchers and college presidents, has been

meeting since 1998 and has commissioned major papers and panel reports to guide

efforts to prevent drinking by students.

Drinking by youth is not limited to college students, and we are reaching children

and adolescents through our Governors’ Spouses Initiative. Spouses of governors in

28 States have joined this project to reduce drinking by young people; a crucial effort, given our findings that early initiation of drinking portends dramatically higher risk of alcoholism later in life. These efforts will be accompanied by public service

announcements on underage drinking.
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GOVERNMENT PERFORMANCE AND RESULTS ACT

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report, which compares our fiscal year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to

identify strategies and objectives to continuously improve its programs.

PREPARED STATEMENT OF DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE

OF NURSING RESEARCH

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Nursing Research (NINR) for fiscal year 2002, a sum of $117,686,000, which reflects an increase of $12,508,000 over

the comparable fiscal year 2001 appropriation.

This year, as NINR celebrates its 15th anniversary, it is encouraging to reflect

on the progress made so far. Nursing research on a broad range of issues has been

stimulated, developed, funded, published, and integrated into practice, where patients and the public are already reaping the benefits of improved health care. Studies include improving management of symptoms and quality of life for the increasing population of patients with longstanding chronic illnesses; smoothing the transition of advanced technologies into people’s lives, such as genetic screening and telehealth; reducing health disparities among minorities and those without adequate access to the healthcare system; and improving care at the end of life. Yet nursing

research is a young science. It must continue to grow to help meet urgent national

health needs, expectations of our nation’s people, and requirements of 2.7 million

registered nurses for well-tested, effective interventions. NINR research is central

in supplying empirical evidence that expands the scientific base for care affecting

people’s physical, psychosocial, and cultural needs.

TRANSLATING RESEARCH FINDINGS INTO PRACTICE AT THE COMMUNITY LEVEL

Let me illustrate how nursing research can influence public and private organizations at the community level—and in so doing, help eliminate health disparities.

NINR study findings addressed an important health issue—low birthweight and

preterm births—and supported research that promoted lower incidence while decreasing costs to the healthcare system. According to the National Center for Health

Statistics, the United States is a disappointing 26th among industrialized nations

in the number of babies per 1000 dying before their first birthday. The national rate

is over 7 deaths per thousand. For African-Americans it is over 14 per thousand.

In North Carolina, where the study took place, investigators targeted low-income African American pregnant women and Caucasian women at particular risk for low

birthweight, including pregnant teens. This five-year project involved a home visit

followed by low-cost, low-tech phone calls by registered nurses to monitor health and

address problems of the women. Results showed that the low birthweight rate for

the treatment group was 10.9 percent, compared with 14 percent for controls. For

African Americans 19 years and older, the results were even more pronounced—11

percent in the treatment group versus 17 percent for controls. For this group, cost

savings to the hospital were $277 per pregnancy. Extended savings also resulted

from a reduction in long-term problems related to low-birthweight.

Investigators expanded the intervention to four programs that included Hispanics,

African-Americans and Caucasians—three programs focusing on low-income women

and one on women of all income levels nationwide. The results equaled or bettered

the original study findings. All four programs are continuing today without Federal

research funding—having been adopted by private sector organizations, including a

national HMO.

IMPROVING DAILY LIVING FOR ALZHEIMER’S DISEASE PATIENTS

This anniversary year presents the opportunity to recognize some notable nursing

science advances. For example, with respect to Alzheimer’s disease patients, an important goal is preserving their functional capacity as long as possible so that they

can bathe, dress and feed themselves. Researchers studied nursing home residents

with Alzheimer’s disease—the most disabled group in these establishments. Their

disabilities were found to be caused by cognitive deficits, but also by the staff’s inability to encourage independence. This can cause disability beyond what can be expected of cognitive impairment alone. The study involved nursing home staff instituting one-to-one interventions to improve the residents’ abilities to bathe and dress.
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First, the residents were examined to determine which skills they retained. Then

the physical and social environment was restructured to reactivate those skills.

Findings indicate that the intervention improved residents’ bathing and particularly

dressing capabilities, and disruptive behaviors were reduced. Improvements were realized within five days’ time and were maintained by the end of three weeks. To

achieve this, however, staff time with each resident increased. Investigators hypothesize that the amount of time can be reduced if the goal is to maintain the residents’

skill levels, rather than to raise them.

END-OF-LIFE/PALLIATIVE CARE RESEARCH

Another issue predominantly affecting seniors, but also affecting people of all

ages, is how to retain quality of living during life’s final phase. NINR has a special

interest in this area and is the Institute that coordinates end-of-life research at the

NIH. A major issue is that, while capable of enhancing life, technologies and treatments can also involve burdensome procedures that may be futile and prolong discomfort and pain. The decision whether or not to withdraw life support, usually

made by family members or friends on behalf of the dying patient, is a difficult decision to make. NINR researchers measured family member stress levels and found

them to be twice as high as those due to other serious crises, such as construction

disasters, or losing a home to fire. This study is one of the first to show that existence of an advance directive eases stress on the family when life-sustaining treatment is withdrawn. When an advance directive existed to guide decisions, the families were better able to focus on patients’ quality of life and less likely to choose

prolonging life at all costs.

FACTORS INFLUENCING OBESITY IN ADOLESCENTS

Obesity can decrease quality of life and shorten life span. According to the Centers for Disease Control and Prevention, 13 percent of children and 14 percent of

adolescents are overweight, continuing the pattern of the past two decades. These

young people are at risk for cardiovascular disease later in life. In a study of 2000

adolescents, a nurse investigator found that for both males and females, the influence on obesity of ethnicity and socioeconomic status was greater than the influence

of watching TV or playing video games. African-American teens and low-income female teens were at special risk, which suggests where the emphases of prevention

programs should be placed. The study also indicated that participation in high-intensity exercises, such as basketball or swimming, may protect boys against obesity.

School physical education and community recreation programs that feature high-intensity physical activities could help lower the obesity rate. Further research is

needed, however, before programs can be developed for girls.

NEW AND EXPANDED INITIATIVES

Turning to the immediate future, next year NINR plans an increased emphasis

on chronic illness. The rise in chronic illness creates an escalating demand for strategies that enable people to live as normal lives as possible, even while they are dealing with chronic illness. Another key factor is caregiving for family members at

home. This practice is increasing in importance as an essential ingredient of the Nation’s healthcare system.

The chronic disease of cancer has special urgency for minorities, because it is they

who bear an unequal burden for this disease. The Healthy People 2010 report states

that African Americans are 34 percent more likely to die of cancer than are Caucasians. New ways must be found to reverse this disturbing trend. NINR plans to concentrate on culturally-sensitive prevention research that focuses on lifestyle factors,

such as alcohol, poor diet, and exposure to environmental toxins. We will also develop and test innovative approaches to increase screening for cancers in minorities,

which should help reduce disease or bring balance to the present unevenness of disease expression among populations.

Chronic pain, prevalent throughout our society, is frequently the reason people

visit doctors and hospitals, and it can significantly influence recovery from illness.

Imagine, however, being in severe pain but not able to tell the nurse or doctor about

it. Many people are in this position, which makes pain treatment all the more difficult. Examples include those who may be cognitively impaired, or cannot speak

English, or are infants unable to talk yet. Next year NINR plans a new emphasis

on pain. Researchers must discover cues that indicate the presence and degree of

pain so that adequate treatment can be provided for those who cannot speak for

themselves. Research is also needed to address other barriers to the effective treatment of chronic pain, including under-reporting of pain and underutilization of analgesics.
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Frequently accompanying chronic illness is cachexia, a condition signaled by muscle wasting and weight loss. Patients with cancer, cystic fibrosis, AIDS, and chronic

lung disease are at risk for cachexia. The impact on quality of life stems from fatigue, weakness and susceptibility to other complications. Despite promising opportunities, there has been limited research attention to this condition. The urgent

needs of patients with long-standing illnesses dictate that cachexia must be addressed.

Those who care for ill family members are sometimes overlooked in the overall

battle against chronic illness. Yet according to the Center for Advancement of

Health, nearly one in four families in our country are involved not only with physical care of their relatives, but also in dealing with behavioral or cognitive problems.

Yet many caregivers must still shoulder their other responsibilities of daily life. The

combination of these demands can put them at risk for poor health, caused in part

by the stress of caregiving and perhaps their own advanced years. NINR plans to

increase research in this area, including studies to promote learning and refining

caregiving skills to benefit the patient, and strategies to safeguard caregivers’ own

health and quality of life.

BUILDING THE CAPACITY TO DO NURSING RESEARCH

NINR must also ensure that the nation maintains a sufficient, well-prepared supply of nurse researchers to provide the empirical evidence necessary for clinical

nursing practice. NINR offers a variety of NIH training opportunities, including

those emphasizing patient-oriented research and research conducted by and involving minorities. We must also address the concerns of the recent report of the National Research Council on the needs for biomedical and behavioral scientists. The

report recommended that NINR emphasize research training that facilitates earlier

entry into research careers. To address this concern, NINR has designed several innovative programs to attract students to early research careers and to shorten the

entry time into research. We also plan to continue our successful Summer Genetics

Institute to fill the need for expert nurses prepared to address the many issues

raised by genetic advances.

In closing, contemporary and future biomedical and behavioral research will continue to emphasize many aspects of what nurses do well—such as ethnic and culturally sensitive approaches, health promotion, and symptom management—all

strong research emphases of NINR. NINR must continue to build good science in

these critical areas.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compared our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

I would be pleased to answer any questions the Committee may have.
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1 National Center for Health Statistics, National Vital Statistics Report, United States Life

Tables, 1998, February 2001.

PREPARED STATEMENT OF RICHARD J. HODES

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute on Aging (NIA) for fiscal year 2002,

a sum of $879,961,000, which reflects an increase of $93,509,000 over the comparable fiscal year 2001 appropriation. The NIH budget request includes the performance information required by the Government Performance and Results Act

(GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes

emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.

Evidence suggests that older Americans are living longer, healthier lives. Life expectancy in the United States has dramatically improved from an average of 49

years in 1900 to 76 years at the turn of the 21st century.1The results of several

national surveys also suggest that older Americans are experiencing better health

and a declining rate of disability. Despite this promising news, we know that good

health is not a universal reality for all older Americans -especially for aging minority groups. Thus, the NIA is committed to supporting high quality research to address the conditions and diseases affecting the elderly population, such as Alzheimer’s disease (AD), osteoporosis, cardiovascular disease, cancer, diabetes, and

physical frailty.

CONQUERING ALZHEIMER’S DISEASE

AD, the most common cause of dementia among older persons, tragically affects

as many as four million Americans who are predominately 65 years and older.

There has been an explosion of recent findings that are yielding important clues

about AD risk factors and disease pathology and, as a result, are suggesting targets

for treatment and prevention.
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In the past year, scientists have identified a number of genetic and non-genetic

AD risk factors. Separate studies concluded that a gene or genes on chromosome 10

may be risk factors for late onset AD-the most common form of AD. Prior to these

findings, the apolipoprotein E (APOE) gene was the only widely recognized genetic

risk factor in late onset AD. Examples of possible non-genetic risk factors uncovered

recently include poor socioeconomic status, low-educational level, absence of extensive social networks, and history of serious head trauma. Evidence from these and

other studies suggests that early life course events may play a role in AD development and could lead to novel interventions.

While research is ongoing to explain how AD develops, scientists are also working

to translate information about risk factors and underlying disease mechanisms into

effective AD treatments. The public and scientific community are particularly excited about an emerging, potentially promising AD vaccine. In a breakthrough experiment last year, which was based upon NIH-supported advances in basic research, pharmaceutical company scientists announced they had developed a vaccine

that in mice appears to slow production of amyloid. Amyloid is the substance, or

peptide, that forms the senile plaques in the brains of AD patients. Their research

showed that repeated long-term injections of an amyloid vaccine can stimulate an

immune response in test mice, nearly eliminating amyloid plaques and associated

neuropathology. (Chart#1) A number of NIH-funded scientists have since confirmed

and extended these observations. Other NIA-supported studies have shown that the

vaccine is effective in preventing cognitive decline in mice. Human trials being conducted by pharmaceutical company researchers are now beginning to test both the

safety and efficacy of these vaccines as a possible therapy for AD. The NIA is discussing potential ways in which the public and private sectors can collaborate to facilitate the success of these critical trials.

The NIA is currently supporting 17 AD clinical trials, seven of which are largescale cognitive impairment and AD prevention trials. These trials are testing

agents, such as estrogen, anti-inflammatory drugs, and anti-oxidants, for their effects on slowing progress of the disease, delaying AD’s onset, or preventing the disease altogether. Other intervention trials being supported by the Institute are assessing the effects of various compounds on the behavioral symptoms (agitation, aggression and sleep disorders) in people with AD. The NIA is also supporting studies

that are testing interventions for improving AD patient care delivery and alleviating

caregiver burden.

REDUCING DISEASE AND DISABILITY

Besides AD, many other chronic diseases and disabling conditions can compromise

the quality of life for older people. Osteoporosis, a skeletal disorder characterized

by compromised bone strength, is one of the seven most common causes of disability

in older people, especially older women. According to the National Institute of Arthritis and Musuloskeletal and Skin Diseases, one out of every two women (as opposed to one in eight men) over 50 will have an osteoporosis-related fracture in her

lifetime. Large observational studies have determined that the use of thiazide

diuretics, an inexpensive treatment for high blood pressure, is associated with higher bone density and about a 30 percent lower risk of hip fracture. To directly test

the effects of low-dose hydrochlorothiazide on bone density in men and women with

normal blood pressure, investigators completed a recent clinical trial. The trial

found that the agent preserved bone density at the hip and spine. The modest effects observed over three years, if accumulated over 10–20 years, may explain the

30 percent reduction in hip fracture risk associated with thiazides in the earlier observational studies. The results of this trial suggest that low-dose thiazide therapy

may have a role in preventing osteoporosis.

Diabetes is another one of the seven major debilitating diseases affecting older

people. Adult onset diabetes, or type 2 diabetes mellitus (DM), is caused by an inability of the beta cells of the pancreas to compensate for increasing insulin demands; consequently, blood glucose levels rise. GLP–1, a glucagon-like gut peptide,

can stimulate beta cells to produce more insulin even in type 2 DM; however, its

biologic half-life is short and its effects quickly diminish. Exendin–4, a newly studied peptide analog of GLP–1, is long-lived and more potent than GLP–1, and has

been shown to reduce blood glucose levels in rodents. A recent study with small

numbers of diabetic and non-diabetic humans demonstrated Exendin–4’s efficacy in

inducing insulin and normalizing blood sugar, even in diabetics. (Chart#2) In the

near future, an exendin-like drug possibly may become an effective treatment for

type 2 DM.

Research has shown that many of the disabling conditions affecting older people

could be diminished through regular exercise. The evidence was enhanced this year
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2 National Long Term Care Survey 1982–1994 (Kenneth Manton, Ph.D.)

by findings that found fitness affects mortality risk regardless of an individual’s

body fat. One study, which followed men 30–83 years of age for an average of eight

years, found that within each category of body fatness,’’fit’’ men (as measured by exercise testing) were at a lower risk of death. In addition, among fit men, obesity was

not significantly related to risk of death. In another study, low fitness increased

mortality risk in men approximately fivefold for cardiovascular disease and threefold for all-cause mortality. Low fitness was associated with higher mortality in all

weight groups. Findings like these motivate the NIA to continue its ongoing campaign to encourage older people to exercise. Since the campaign was launched in

1998, the NIA has distributed over 350,000 copies of its exercise guide and over

15,000 copies of its companion video to the public.

BIOLOGY OF AGING

In keeping with its mission, the NIA supports research on diseases and conditions

affecting the elderly as well as on the normal aging process. To understand the

aging process, it is important to identify those factors that affect the overall life

span of an organism. Toward this end, NIA supports and promotes research on the

biochemical, genetic, and physiological mechanisms of aging and the onset of agerelated disease. Experiments in a number of animal models, such as mice, fruit flies,

and nematodes (roundworms), are providing valuable insights.

Understanding factors that contribute to longevity in animal models, and how

these factors may apply to humans, are of major interest to the NIA. The role that

oxidative stress, for example, may play in the aging process continues to be explored. In the last year, investigators announced that they had extended the average life span of nematodes via pharmacological intervention targeting oxidative

stress. Using an artificial compound, EUK–134, which mimics enzymes that reduce

oxidative damage, researchers extended the life span of nematodes by about 50 percent. The intervention also reversed premature aging in a nematode strain subject

to elevated damage. These results strongly suggest that oxidative stress is a major

factor in the rate of aging in the nematode and may be slowed by pharmacological

intervention. It may be that similar compounds could lessen oxidative stress in humans and delay or reduce age-related pathology.

Caloric restriction, which entails a diet that includes all of the necessary nutrients

but fewer calories, has been shown to slow the intrinsic rate of aging and to delay

and reduce the onset of diseases, such as cancer. In rodents, it was demonstrated

recently that caloric restriction can also increase resistance of neurons to age-related and disease-specific stresses, suggesting that it may be an effective approach

for reducing neuronal damage and neurodegenerative disorders in aging. Although

the effects of caloric restriction on humans have not been evaluated, this year, the

NIA announced an initiative to begin studying the effects in humans of sustained

caloric restriction on physiology, metabolism, body composition, risk factors for agerelated pathologies, progression of age-related changes (where feasible), and its potential adverse effects. Results of these studies could be valuable in the development

of better methods of preventing multiple age-related diseases.

BEHAVIORAL AND SOCIAL RESEARCH

Behavioral and lifestyle factors have a profound impact on health throughout the

life span. Thus, the NIA supports behavioral and social research, including demographic research, to elicit information about the health of older people, their socioeconomic status and the social and behavioral influences that affect their lives.

Demographers reported some of the most promising news of the last decade related to the health status of older Americans. In a landmark study, researchers used

the 1982 disability rates from the National Long Term Care Survey (NLTCS) for

people aged 65 and older to estimate the numbers of disabled persons in each future

year using census bureau projections. They then used subsequent waves of the

NLTCS to determine the actual numbers of disabled persons and compared that to

their estimates. Using this method, they observed 1.6 million fewer disabled older

people in the U.S. in 1998 than there would have been if the disability rate had

not changed since 1982.2 (Chart #3) These decreases in disability have been confirmed using several independent databases and have been shown to benefit both

men and women, and minority as well as non-minority populations. The latest preliminary findings from the 1999 NLTCS suggest that the rate of decline in chronic

disability is continuing and may even be accelerating. Research is ongoing to understand the potentially significant long-term economic and social consequences of disability decline, including its effect on health care costs and the American workforce.
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Importantly, research has also begun to identify the factors contributing to the decline so that specific interventions and behavioral changes can be designed that

might sustain or accelerate trends in improved function and quality of life among

older Americans.

NIA encourages research with the aim of not only extending life, but also improving the quality of life. One factor contributing to a higher quality of life in later

years may be a positive outlook. A recent study demonstrated that emotional vitality is associated with decreased mortality and is correlated with slower progression

of disability in disabled older women (aged 65 years and older). Using data from

the Women’s Health and Aging Study, a longitudinal study of disabled women, researchers found that women who were classified as emotionally vital (i.e. upbeat

and positive) at the beginning of the study maintained better physical function over

time than women who were not emotionally vital. Although more research is necessary to elucidate the possible role of emotions in protecting against health decline,

these results suggest that helping older people maintain a high level of emotional

vitality may help prevent or slow physical decline.

CONCLUSION

Many people have assumed that old age is always associated with increased disability. As little as five years ago, researchers could not conceive of an approach to

preventing Alzheimer’s disease (AD). However, through research advances, the nation has renewed hope that scourges, like AD, may be treated or prevented one day.

Americans can also foresee the possibility of living a long, satisfying life free of

major disability. To continue its trajectory of recent success, the NIA recently released its five-year strategic plans for aging research and research into health disparities. The goals are ambitious. However, these documents provide a framework

that the Institute will be using to continue the tremendous progress made in the

last century. By continuing and intensifying research, NIA can move forward in

meeting the promise of extended life by improving the health and well-being of older

people in America.
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PREPARED STATEMENT OF STEVEN E. HYMAN, M.D., DIRECTOR, NATIONAL INSTITUTE

OF MENTAL HEALTH

Mr. Chairman and Members of the Committee, I am pleased to present the President’s budget request for the National Institute of Mental Health (NIMH) for fiscal

year 2002, a sum of $1,238,305,000, which reflects an increase of $131,576,000 over

the comparable fiscal year 2001 appropriation.

MENTAL DISORDERS ARE ENORMOUSLY DISABLING

Mr. Chairman, mental disorders constitute extraordinarily significant causes of

disease burden in the United States and worldwide, with their greatest contribution

to that burden resulting from their disproportionate impact on disability. According

to the World Health Organization (WHO), major depression is the leading cause of

disability in the United States and, indeed, throughout the developed world, and

four mental illnesses rank among the top ten causes of disability. In recognition of

this fact, the WHO has designated mental health as the topic of the World Health

Assembly to be held in May in Geneva, which will be attended by Secretary Thompson and health ministers from all member nations within the U.N. In addition, mental health will be the sole topic of WHO’s World Health Report for 2001, which

should provide a significant platform for improved understanding worldwide. The

World Health Report will complement the extremely well-received Surgeon General’s Report on Mental Health issued by Surgeon General David Satcher in December 1999 in the United States. The NIMH takes great pride in having served as the

critical advisor to both the United States and World reports.

CO-OCCURRING MENTAL AND GENERAL MEDICAL DISORDERS

The impact of mental illness on disability is well known. Less well known, but

increasingly well documented, is the fact that mental illness can have a significant

impact on the incidence and course of general medical disorders. In March, NIMH

sponsored a conference in Pittsburgh that was attended by a member of this panel,

Congressman Kennedy, and a member of the Senate, Senator Arlen Specter, which

focused on this issue of co-occurrence, or comorbidity. Scientists presented overwhelming evidence for a physiologic role of depression in the progression of heart

disease, including a contribution to heart attacks and death. Of course, depression

may interfere with a person’s ability to engage in rehabilitation or to adhere to diets

and complex medical regimens. But that is far from the whole story. Depression

causes excessive release of stress hormones, such as cortisol and adrenaline that can

have negative effects on metabolism and on the heart. Depression may also make

the heart more prone to abnormal rhythms, and may alter the stickiness of platelets. There is strong evidence that the fundamental pathologic processes leading to

Parkinson’s disease often also lead to severe depression, which, in turn, can markedly exacerbate this disabling and tragic disorder. And research points to the role

of depression as a contributor to mortality in cancer and AIDS. Some treatments

for general medical illnesses may also cause depression by altering brain chemistry.

Treatment of cancer with high dose interferon—is often limited—indeed, often terminated—as a result of interferon-induced depression. Early treatment with

antidepressant medication was shown this year to minimize depression and facilitate cancer treatment. Separation of ‘‘mind’’ and ‘‘body’’ in medicine is folly. Mental

disorders are illnesses of the brain. By themselves these disorders cause enormous

suffering and disability, but in addition, by altering hormone release, appetite,

sleep, and other somatic systems, mental illnesses have a deleterious—and often

preventable—impact on organs outside the brain.

STRATEGIC RESEARCH PLANNING TARGETS MOOD DISORDERS

The conference on depression co-occurring with other medical illnesses was held

in conjunction with an exciting effort to engage the Nation’s leading mood disorder

researchers in our ongoing strategic planning process. The effort, entitled ‘‘Breaking

Ground, Breaking Through: A Strategic Plan for Depression and Bipolar Disorder

Research,’’ will identify scientific areas that offer significant opportunities for

progress or in which there are currently significant gaps. Participants analyzed the

state-of-the-science in nine areas, ranging from genetics, to the neural and behavioral substrates of mood regulation, to an assessment of barriers to care for patients

at all points across the lifespan and in all of our racial and ethnic minority groups.

These reports will be published in a leading scientific journal later this summer,

and will provide the grist for updates to our NIMH Strategic Plan. This plan, which

is publicly discussed by our National Advisory Council on a regular basis, plays a

critical role in our engagement with the scientific community as well as with other
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stakeholders. We believe that accountability to the Congress and to the American

people demands that we publicly state our goals for the advancement of diagnosis,

treatment, and ultimately cure and even prevention of mental illnesses.

MOLECULAR GENETICS TOOLS BENEFIT MENTAL ILLNESS RESEARCH

In the foregoing, I have highlighted the enormous public health need created by

the current realities of mental illness, and have alluded to the way in which NIMH

plans to address that need. Of course the best intentions in research can go nowhere

without scientific opportunities—opportunities based in a well-trained scientific

community, powerful technologies, and good scientific leads. Fortunately for individuals with mental illness and their families, there are now unprecedented scientific

opportunities to address these terrible disorders , and it is this conjunction of public

health need with exciting and forward-looking science that truly justifies our budget

request.

At NIMH, a critically important use for new funds is for research that can capitalize on the fruits of the genome project. As with most of the serious chronic illnesses that affect humanity, the major mental disorders have a substantial genetic

component. For some of the most disabling disorders, including autism, schizophrenia, and bipolar disorder, the genetic aspects of risk are extremely potent,

greater than those observed, for example, for most forms of coronary artery disease,

type II diabetes, or hypertension. Finding the genes implicated in mental disorders

is critical to accurate diagnosis, the discovery of effective new drugs, and fundamental understanding of the disease processes. Mental disorders do not result from

the deterministic action of a single gene, but rather result from the interplay of multiple genes each exerting a small increment of risk, together with environmental

risk factors. Prior to the human genome project it was hard to see how we would

succeed in piecing these difficult puzzles together. That is all changed now. With

the tools of the genome project in the offing, NIMH-funded investigators are engaged in large-scale collection of DNA samples from people with schizophrenia, bipolar disorder, autism, early-onset major depression, and other disorders. In addition,

in the coming year, NIMH plans to begin to collect DNA samples from the well-characterized participants in our large-scale clinical trials. In addition to providing information about the causes of mental illness, genetics can help us to understand why

some individuals respond to one treatment and not another, helping to usher in an

age of individualized treatment. The result will be appropriate treatment selection

for an individual to maximize efficacy and minimize unwanted side effects.

Modern molecular tools are changing not only genetics, but also brain biology. The

last 3 years have seen steady progress in the development of technologies in which

very dense arrays of DNA or protein samples are printed on a glass slide or other

support. These functional genomic and proteomic ‘‘microarrays’’ permit us to ask, for

example, whether a gene or protein is expressed at a higher or lower level in diseased tissue versus healthy or in a drug treated sample versus a control comparison.

With a few such slides we can now look for patterns of change in thousands of genes

at once. Promising research with such microarrays supported by NIMH is underway. In the past year we saw the first application of these technologies to postmortem brain tissue from individuals who had suffered with schizophrenia and

other serious mental disorders. In brains from people with schizophrenia, a class of

genes governing the function of synapses in the brain were expressed at clearly different levels than those observed in the comparison brains. This research, published

in leading journals, has opened a new window on the causation of mental illnesses

and the effects of treatment on the brain.

ANIMAL MODELS CAN PROVIDE MENTAL DISORDER PHENOTYPES

It is often not recognized that genetics creates new opportunities, not only for biologists, but for behavioral scientists. Using the tools of genetics well demands that

we have a greater understanding of the symptom clusters and course of illness in

people who constitute individual diagnostic groupings. At the same time, we recognize that the need to understand the precise mechanisms that cause disease require

animal models. The ability to alter the mouse genome, almost at will, with the resulting production of animals with altered behavior has revealed a shortage of scientists who can analyze animal behavior and who can relate it to its neural or genetic substrates. The need for interdisciplinary scientists, individuals who bridge genetics, neuroscience, and behavioral science, was highlighted in a report released in

the past year by the Institute of Medicine. Their thoughtful recommendations on

training the next generation of scientists, scientists who can marshal our new technologies to solve critical problems related to mental disorders, are currently being

implemented.
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In the specific area of animal models aimed at understanding disease, we have

collaborated with other NIH institutes that support brain research to develop centers around the country that will make novel mouse mutations and identify neural

and behavioral abnormalities. An important aspect of this program is that all useful

models will be shared throughout the research community. While no one expects to

derive a perfect mouse model of schizophrenia or bipolar disorder, there is a great

likelihood of finding mutations that model significant aspects of mental illnesses.

These will be used to understand what goes wrong in the brain to produce such disorders, and most important, as screening tools to develop new treatments. These

powerful approaches to biology—large-scale mouse mutagenesis, and high throughput screening for behavioral and nervous system phenotypes of interest—span the

interests of multiple neuroscience-based NIH institutes.

CLINICAL TRIALS, INCLUDING CHILD MENTAL DISORDER STUDIES

We have also carried out a major expansion of our efforts in clinical trials. This

expansion relates not only to the numbers of needed trials, but also to their intellectual basis. We have expanded our trials beyond their usual endpoint-answering the

question of whether a medication or psychotherapy was safe and effective-to questions of whether our treatments will work for ‘‘real world’’ patients in diverse ‘‘real

world’’ treatment settings such as primary care clinics and neighborhood health centers.

One important aspect of our clinical trials program is our network of Research

Units in Pediatric Psychopharmacology (RUPPs). In the last month, these units

have produced an important result, published in the New England Journal of Medicine, showing substantial efficacy and also safety of a selective serotonin inhibitor

(SSRI) drug in the treatment of children with serious anxiety disorders who had not

improved with behavioral therapy. Given the dire need to establish the safety and

efficacy of treatments for children with depression, bipolar disorder, anxiety disorders, autism, and many other mental disorders, and given the initial success of

these units, we are delighted that the fiscal year 2002 budget request should permit

an expansion from 7 to 10 units within the network in the coming year.

The NIH Autism Coordinating Committee (ACC) will work to increase emphasis

in the area of autism research, including more rapid implementation of the centers

program mandated under the Children’s Health Act of 2000.

Later this month, the National Advisory Mental Health Council Child Workgroup

is expected to issue a report recommending that NIMH strengthen research in this

area, including acceleration of interdisciplinary and multi-site research to develop

new interventions—both psychosocial and pharmacologic—for child and adolescent

disorders and to deploy these treatment strategies to front-line clinicians. We already are developing fiscal year 2002 initiatives that will lay the groundwork for

a series of child treatment research networks designed to develop new treatments

over the next decade. The expanded networks will direct resources to research on

bipolar disorder, autism, depression in prepubertal children, and comorbid conditions that adversely affect child development. A parallel research network will address the critical question of how we can effectively disseminate evidence-based care

within different provider practices, communities, and service systems.

JOHN EDWARD PORTER NEUROSCIENCE RESEARCH CENTER

In collaboration with the National Institute of Neurological Disorders and Stroke

and seven other NIH institutes, we are moving ahead with development of a national Neuroscience Research Center (NRC) on the NIH campus, a bold initiative

that is essentially dictated by the pace of progress in integrative neuroscience. The

new center builds on the recognition that progress in our science demands that we

overcome any balkanization that has occurred. Specialized investigators working on

discrete facets of brain disease have advanced our field enormously over the past

decade. Now, however, the challenge before us is to reintegrate the information we

have accumulated: to look at single neurons in the context of larger neuronal ensembles, and those in the context of brain circuits and systems, all the way up to the

level of the behavior of living organisms. Throughout this testimony I have described the need to build bridges across disciplines. The Neuroscience Research Center will serve as a wonderful model for such collaborations, which can capitalize rapidly on our exciting new ideas and technologies, and translate as rapidly as possible

basic discoveries into the clinical arena.

Mr. Chairman, the NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) Of 1993. Prominent

in the performance data is NIH’s second annual performance report which compares

our fiscal year 2000 results to the goals in our fiscal year 2000 performance plan.
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As performance trends on research outcomes emerge, the GPRA data will help NIH

to identify strategies and objectives to continuously improve its programs. I will be

pleased to answer any questions.

PREPARED STATEMENT OF STEPHEN I. KATZ

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Arthritis and Musculoskeletal

and Skin Diseases for fiscal year 2002, a sum of $443,565,000, which reflects an increase of $46,962,000 over the comparable fiscal year 2001 appropriation.

It is an honor for me to have this opportunity to share stories of progress and

opportunity in the research within our mission areas. Improving daily life is the

driving force for the research that we support and conduct at the National Institute

of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Virtually every home

in America is touched by diseases affecting bones, joints, muscles, and skin. We are

committed to better understanding, diagnosis, treatment, and prevention of these

diseases and disorders that are often chronic and disabling, many of which disproportionately affect women and minority populations.

HEALTH DISPARITIES

Research has revealed that many of the diseases within our mandate affect

groups such as African Americans, Hispanic Americans, American Indians, Alaskan

Natives, and Asian Americans both in increased numbers and increased severity.

For example, the prevalence of lupus is higher among African Americans and Hispanic Americans, and these groups also experience more complications of lupus; African Americans also have higher rates of hip and knee osteoarthritis; scleroderma

occurs with greater frequency in Choctaw American Indians; and African American

people are also disproportionately affected by overgrowth of scar tissue (keloids) and

by loss of pigmentation (vitiligo), both of which may be severely disfiguring.

Health Partnership Program. The health of a nation depends on the health of its

communities. Recognizing this, the NIAMS is launching the first phase of its Health

Partnership Program—A NIAMS Diversity Outreach Initiative, a new program to

address the health disparities in joint, muscle, bone and skin diseases that exist in

minority communities. The initial phase of this Program has begun as a model community-based program in the African American community in the metropolitan

Washington, D.C., area, with the focus on rheumatic diseases. As a component of

this partnership, plans are also underway for a new rheumatology clinic to be located in a centrally accessible area of Washington, D.C.

Recruitment to Research Careers. Specific strategies are underway and planned

to increase the number of underrepresented minority investigators in the biomedical

research fields related to the diseases within our mandate. The Institute, along with

many other NIH Institutes, has recently issued a Request for Applications for planning grants for clinical research training in minority institutions as a first phase

of this initiative. The second phase will be a five-year grant to assist in the actual

development of clinical research curricula. A successful program will produce welltrained clinical researchers who can lead clinical research projects.

RESEARCH IN CHILDREN

The NIAMS has undertaken a number of programs and activities focused on children to enhance our understanding of childhood diseases and to develop improved

treatments for our younger generation. For example, the NIAMS Intramural Research Program launched an exciting and promising initiative in the fall of 2000 at

the NIH research hospital—the new NIH Pediatric Rheumatology Clinic. The clinic

offers diagnosis, evaluation, and treatments for children with arthritis and other

rheumatic diseases. The clinic will provide children with a place where they can be

diagnosed and treated in a state-of-the-art facility, and researchers can learn much

more about rheumatic diseases. In addition, treatment for juvenile rheumatoid arthritis has been significantly improved with the results of a recent clinical trial that

showed Enbrel (etanercept) is a safe and effective drug in the treatment of children and teenagers with juvenile rheumatoid arthritis (JRA). This clinical trial was

conducted by researchers at one of the NIAMS Multipurpose Arthritis and Musculoskeletal Diseases Centers and investigators in the Pediatric Rheumatology Collaborative Study Group. The success of this clinical trial is also the culmination of many

years of basic research supported by the NIAMS and other NIH components. These

findings offer hope for children with juvenile rheumatoid arthritis, hope that they

may live their lives as active children. In other research involving children, we now
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understand that osteoporosis may actually start in childhood. Research studies in

young girls revealed that minor variations in a gene for the bone protein collagen

can lead to lower bone density. These minor variations in this gene, while not causing apparent disease, may define a high susceptibility group for osteoporosis later

in life. Identifying and understanding genetic susceptibility to osteoporosis early in

life may facilitate the targeting of interventions to those who will most profit from

them.

BONE BIOLOGY AND BONE DISEASES

Bone is metabolically a very active tissue, constantly undergoing build up of new

bone and resorption of old bone. Bone remodeling is a normal, but carefully balanced process. Bone diseases like osteoporosis can result from an imbalance in this

process and osteogenesis imperfecta can result from the mutation of bone-producing

genes, and both diseases result in low bone density, fragile bones, and increased

susceptibility to fracture. Research has taught us that many factors affect bone density and strength, including genetic, nutritional, environmental, and others. Basic

research has provided the foundation for our understanding of bone and has revealed some intriguing and potentially important scientific opportunities. For example, researchers found that statins, drugs that lower serum cholesterol, increase the

production of a bone-enhancing molecule. This is leading to work on the development of similar drugs that can be directly delivered to the bone for maximum effect.

Other studies showed us that a protein called leptin, which has an established role

in controlling food intake and other aspects of behavior and physiology, seems to inhibit bone formation in animal models. Researchers will pursue this finding with

the goal of designing drugs to specifically block leptin’s action on bone and restore

lost bone.

MUSCLE BIOLOGY AND MUSCLE DISEASES

There are many forms of muscular dystrophy, and the NIAMS has teamed with

our colleagues in other components of the NIH, particularly the National Institute

of Neurological Disorders and Stroke, to bring a strong focus to basic and clinical

studies of muscular dystrophy. Last year we sponsored major scientific conferences

in both Duchenne Muscular Dystrophy (DMD) and Facioscapulohumeral dystrophy

(FSHD), issued research solicitations signaling our strong interest in the submission

of high quality research applications in understanding and treating muscular dystrophy, and have funded a research registry for FSHD and myotonic dystrophy that

will facilitate research by serving as a liaison between families affected by these diseases, and researchers who want to study these disorders.

SKIN BIOLOGY AND SKIN DISEASES

This has been a particular productive year in research on skin biology as well as

skin diseases. Highlights of progress include: (1) ground-breaking research on impetigo, a common infection among children aged 2 to 6. The bacterium Staphylococcus

aureus, cause of the common skin infection bullous impetigo, produces a toxin that

attacks a protein highly specific for cell-to-cell binding in the outermost layer of the

skin. Researchers have reported that breakup of this protein not only brings about

the characteristic blistering, but also gives the bacterium a specific mechanism to

circumvent the skin’s protective barrier and spread further. (2) The gene causing

Pseudoxanthoma Elasticum has been identified. Pseudoxanthoma elasticum is an

inherited disorder characterized by progressive calcification of elastic fibers in the

skin, eye and cardiovascular system. This disease is inherited and can have severe

manifestations in these organ systems. Work is continuing to determine the function

of the gene and how mutations in the gene result in the clinical disease. This discovery should allow for the eventual determination of the cause and, ultimately,

allow the design of therapeutic interventions for the treatment of this disease. (3)

Advances in understanding hair development and treating hair diseases have been

reported. A number of skin diseases affect hair cycle resulting in various abnormal

types of hair loss as well as the hair loss normally associated with aging. An understanding of the events in hair development, cycling, and the mechanism of hair loss

in various diseases will allow for the development of treatments to correct these abnormalities. Knowledge of the molecular mechanisms involved in the continuously

repeated cycle of resting, shedding, and regrowth means that hair biology is useful

not only as a way to understand hair diseases such as alopecia areata, but also for

understanding of other cycling and regenerating tissues. The research advances that

have increased our understanding of the hair follicle system and the chemicals and

signaling molecules involved in its cycling will allow the development of specific
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interventions to treat hair diseases, both naturally occurring, such as alopecia

areata, and those induced by certain cancer chemotherapeutic treatments.

CONCLUSION

The vitality of our bones, joints, muscles, and skin is key to the length and quality

of our lives. Basic research has taught us much about how these components of our

bodies function normally and what goes awry and causes the enormous number of

diseases and disorders affecting bones, joints, muscles, and skin. Clinical research

helps us to understand the nature of disease, and improves our ability to diagnose,

treat, and prevent disease. Medical research supported by the NIAMS has made significant strides in improving health and quality of life, and we are committed to

pursuing promising research opportunities that will continue to improve the health

of the American people. We are investing in the future health of our nation, and

American people of all ages and population groups will benefit from these investments.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is the NIH’s second annual performance report which compares our

fiscal year 2000 results to the goals in our fiscal year 2000 performance plan. As

performance trends on research outcomes emerge, the GPRA data will help NIH to

identify strategies and objectives to continuously improve its programs.

I will be happy to answer any questions that you may have.

PREPARED STATEMENT OF GERALD T. KEUSCH, M.D., DIRECTOR, JOHN E. FOGARTY

INTERNATIONAL CENTER FOR ADVANCED STUDY IN THE HEALTH SCIENCES

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the Fogarty International Center for fiscal year 2002, a

sum of $56,449,000, which reflects an increase of $5,967,000 over the comparable

fiscal year 2001 appropriation.

The Fogarty International Center (FIC) plays a unique role in the efforts of the

United States to improve the health of the American people and of those who live

in developing regions in Africa, Eastern Europe, Asia, and Latin America. The

wealth of nations depends upon the health of people. A healthy world is a safer

world, for our nation and for those less fortunate with whom we share this amazing

and beautiful planet. Virtually all FIC research and training efforts are aimed at

reducing the disparities in health that exist between the peoples of the developing

world and those who live in countries that enjoy the vast advantages of prosperity.

FIC was established in 1968 to honor Congressman John E. Fogarty of Rhode Island. The Center embodies his vision that because ‘‘disease knows no boundaries,

so also the benefits of medical research and indeed research itself can know no

boundaries.’’ FIC is carrying this vision into the 21st Century. Through its leadership role, program initiatives, and analysis of global science and health policy, FIC

plays a central role in NIH efforts to harness the fruits of science for global health.

Research advances made abroad often contribute to improvements in health in the

United States. For example, research in Bangladesh establishing the physiological

basis and practical use of oral rehydration therapy for cholera has led to adoption

in the United States of this simple and inexpensive treatment of diarrheal disease,

particularly frequent in infants and children. Research to develop diagnostic tests,

new drugs, and other therapeutic strategies for HIV/AIDS, tuberculosis, and other

diseases present both in the United States and abroad, is beneficial to all, no matter

where it is undertaken. Adapting biomedical research advances to populations at

home and elsewhere in the world requires a continuing commitment to basic science

as well as rigorous clinical research by both American and foreign collaborating scientists. Success in these endeavors requires the creation of a vibrant research infrastructure and trained research staff in collaborating centers internationally. This is

what FIC does best.

In carrying out its mandate, FIC supports medical investigators in over one hundred twenty U.S. institutions who collaborate with medical scientists in more than

ninety nations. These efforts are multidisciplinary, embracing clinical, epidemiological, basic biomedical, and behavioral research. Although FIC acts to foster collaborative efforts in all parts of the world, it has placed special emphasis on training

medical research personnel in those nations with the least resources. Such countries

bear a disproportionate burden of illness and premature death, not only from communicable diseases but from non-communicable chronic diseases as well.
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CHALLENGES IN GLOBAL HEALTH

FIC efforts to address the challenges in global health research are carried out

through 20 research and research capacity building programs, as well as through

policy and coordination efforts. With more than 35 million persons worldwide infected with HIV, AIDS is a global emergency and has been identified as a threat

to our national security. In addition to individual tragedy, one person at a time,

there are profound societal consequences including economic loss, social disintegration, and political instability. ‘‘Each man’s death diminishes me,’’ wrote John Donne

centuries ago, ‘‘because I am involved with mankind.’’ AIDS prevention, treatment,

care, and ultimately cure are universal concerns because the people of the world are

increasingly connected by trade, travel, and, unfortunately, threats to health.

To address the burgeoning pandemic, FIC launched the AIDS International Training and Research Program (AITRP), now in its 13th year. AITRP has provided research training for more scientists and health professionals from developing countries than any other program, fostering collaborative links between research institutions in the most affected areas in Africa, Asia, and South America and leaders of

American medicine. AITRP trainees have been in the vanguard of the most successful efforts to reduce new infection and to keep infection rates low. Their efforts have

contributed to numerous scientific discoveries and implementation of programs to

reduce HIV transmission. Now that antiretroviral therapy may be within the reach

of the highly stricken poor nations, a massive effort to build organizational infrastructure and train the large number of professionals required to assure the safe

and appropriate use of these complex drugs is the critical bottleneck to success.

Having developed extensive HIV research and training networks among U.S.

Schools of Medicine and Public Health and counterparts in developing nations, FIC

is in a unique position to enlarge the pool of professionals necessary to support such

an effort. We cannot afford not to succeed.

Malaria, once rampant in the United States, including this capital city, has resurged and spread in endemic regions in Latin America, Africa and Asia. An added

complication is that the malaria parasite has developed drug resistance. For these

reasons, Americans remain at risk when they travel to endemic regions of the world,

each year in increasing numbers. New strategies are needed to meet this global

challenge that claims approximately 2.7 million lives annually, largely in tropical

countries. FIC has implemented a new malaria research and training program to

link research to control. In addition, FIC efforts to create a global coalition to address malaria have resulted in the Multilateral Initiative on Malaria (MIM), a new

type of international collaboration designed to create research capacity among African scientists and to generate information in the field. As the current MIM Secretariat, FIC has overseen the enlargement of the MIM research portfolio, expanded

its training activities, and increased the number of sponsoring partners. Today,

MIM is the essential research counterpart for Roll Back Malaria at WHO and together these two initiatives represent the major global collaborations to combat malaria.

Well over ten million people in the United States and 2.1 billion people worldwide

are infected with the tubercle bacillus. This ancient infection still results in more

than 2 million deaths annually. One third of tuberculosis in the United States is

attributed to infection contracted elsewhere and effective treatment is thwarted by

the global emergence of TB strains with multiple drug resistance. To meet this

threat, FIC started the Tuberculosis International Training and Research Program

that focuses on improving clinical and laboratory practices and the training of medical research scientists. Now in its 5th year, it is an essential component of the global strategy to contain the tuberculosis epidemic and has led to important new control measures. One product of this research is a rapid, reliable, simple and inexpensive diagnostic test, which can be adapted to determine drug susceptibility.

Loss of plant and animal biodiversity is a worldwide phenomenon. The medical

consequences, though less obvious, are just as serious as the effects on ecology. With

the loss of plant biodiversity there is an irrevocable loss of natural products that

have traditionally been the source of front line drugs such as quinine for malaria

and digitalis for heart disease. The FIC-led International Cooperative Biodiversity

Groups Program is a model for ethical bioprospecting in the search for new drugs

while it promotes high quality science through multi-purpose partnerships between

U.S. and developing country universities, major pharmaceutical companies, and

non-governmental organizations. More than 6,000 species have been examined for

biological activity in 13 therapeutic areas. Fifty substances of interest have been

found and 15 have been selected for further research because initial studies indicate

they may prove useful to treat malaria, leishmaniasis, and tuberculosis.
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In response to the increasingly complex questions concerning the social and ethical dimensions of international research, FIC initiated and organized the Global

Forum on Bioethics in Research, the first international effort to address critical

issues related to the bioethics of conducting research in developing countries. FIC

also established the first international bioethics training and research program to

develop a cadre of qualified ethicists and health professionals from the developing

world who can work in partnership with clinical investigators. They will shape and

implement research programs and ethical research policies in their home countries

to insure that human subjects receive equal protection from research risks, as do

participants in research in the United States.

In collaboration with the National Science Foundation, FIC initiated a research

program to study the role of ecological factors that influence the emergence of infectious diseases. This program addresses a critical need, to predict and prevent an infection from emerging rather than confront it after the problem appears. It brings

together unique research teams composed of climatologists, epidemiologists, ecologists, vector biologists, entomologists, and microbiologists to develop predictive models of emerging infections. For example, the last El Nino preceded an upsurge in

diarrheal disease in Latin America and malaria in Africa. To be forewarned is to

be forearmed.

Under FIC leadership, innovative research is being initiated to investigate linkages between investments to improve health and economic performance in developing countries. Healthier people living better lives remains an elusive dream and

the Alma Ata declaration has fallen far short of its lofty goal of ‘‘Health for All by

2000.’’ Research results from FIC’s International Studies in Health and Economic

Development Program will help the U.S. and other nations working to enhance economic development in the poor countries of the world understand how best to

achieve, at lowest cost, the goals of healthier, better educated people living better

in politically stable nations around the world.

As we look to the future, FIC will both strengthen existing programs and respond

to needs and opportunities with innovative new initiatives.

FISCAL YEAR 2002 INITIATIVES

To address the growing pandemic of tobacco-related illness and death, now shifting from the developed to the developing nations, FIC will explore how to diminish

the initiation of smoking by youth and adolescents. The objective of the International Tobacco and Health Research and Capacity Building Program is to generate scientific information on biological, behavioral, and policy factors that will lead

to effective control measures to reduce smoking initiation and enhance cessation.

The results of these efforts will be applicable in the U.S.

New advances in clinical research are needed to translate basic research into clinical practice and to develop effective public health policy and programs. There are

too few well-trained clinical researchers in low- and middle-income countries. Even

fewer have policy experience to deal with research and health care. Clinical researchers are needed to address multi-dimensional medical care needs for AIDS patients, and the prudent use of antibiotics to deter the further emergence of antibiotic

resistance. Travelers, refugees, and pilgrims spread resistant microbes worldwide

with shocking speed. The International Clinical, Operational, and Health Services

Research and Training in Communicable Diseases program will train new clinical

researchers in developing countries who understand how to translate their research

into practice.

Since Biblical times, those afflicted with disfiguring illnesses of body and distortions of mind have been shunned and cast aside. Such stigma is a burden both to

the afflicted and the social compact. Stigma, acting through prejudice, diminishes

patients’ access to care and even their participation in research designed to alleviate

suffering. The Stigma Research Initiative will examine the causes of and response

to stigmatization of patients with such diseases as HIV, mental illness, epilepsy,

drug or alcohol addiction, and physical disabilities, in the U.S. and abroad. Through

epidemiological and social science studies on the roots of stigma, its expression and

outcomes, new strategies can be identified and tested to relieve its effects and to

enhance the well being of patients, communities, and nations.

Publication of the human genome is an extraordinary achievement that creates

a wealth of opportunities to identify genetic determinants of susceptibility and resistance to disease. New discoveries to prevent and treat infectious diseases will

stem from this knowledge, aided especially by new information on the genomes of

microbial pathogens (most recently Strep pyogenes, the cause of ‘‘strep throat’’,

rheumatic fever, ‘‘flesh eating’’ necrotizing fasciitis, and toxic shock) and insect vectors. Now for the first time, scientists can target with precision the development of
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a drug or a vaccine for a specific microbe. For example, over a dozen genes have

been identified that relate to the susceptibility to malaria. Efforts in malaria vaccine

and drug development are now utilizing this new information.

From the very beginning of research on the human genome there has been concern about ethical issues that relate to medical applications and the protection of

the individual. To permit the expansion of genetics research in developing countries,

a new program, Incorporating New Genetic Tools into Global Health Strategies, will

foster the development of ethically responsible international research and training

in the use of modern genetic technologies. U.S. and foreign scientists will forge collaborations to define the genetic influences on conditions that affect both populations, and to discover the ways and means to improve health and reduce disparities at home and abroad.

CONCLUSION

The pursuit of health through international scientific cooperation is an inherently

global enterprise and one that ultimately improves the public health of our nation.

Just as trade and communications have tied the world together, advances in biology

have demonstrated our social and global interdependence. ‘‘Science knows no country’’, said Louis Pasteur ‘‘because it is the light that illuminates the world.’’ The genome project, the recognition that improved health is a determinant of economic development, and the impact of ecological changes on the emergence of infectious diseases all contribute to a deepening consensus that individuals and nations share

common interests and responsibilities. The programs of the FIC advance this vision

though their support of research and training focused on global health disparities

and enabling effective collaborations between American and foreign scientists. FIC

leadership and accomplishments enhance our national efforts to achieve better

health for Americans and for those less fortunate in the developing world.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

Thank you Mr. Chairman. I will be pleased to answer any questions.

PREPARED STATEMENT OF RICHARD D. KLAUSNER

Mr. Chairman and Members of the Subcommittee: I am Richard Klausner, the Director of the National Cancer Institute (NCI). I am pleased to appear before you to

present a brief review of some of the activities supported by the NCI and to present

the President’s budget proposal for fiscal year 2002. The significant budget increases

over the past several years have allowed the NCI to aggressively implement its strategic plans to:

—Support a broad-based portfolio of superb research to increase our knowledge

about all aspects of cancer.

—Translate basic science to transform all aspects of cancer prevention and care

—Train the next generation of cancer researchers

—Address both the quality of cancer care and the disparate burden of cancer experienced in America across the cancer continuum.

CANCER TRENDS

Four years ago, the NCI initiated an annual report to the Nation on the burden

of cancer. This report is developed in collaboration with the American Cancer Society, the Centers for Disease Control and Prevention and its National Center for

Health Statistics. This spring, we will report the latest cancer statistics for the

country through 1998. Total cancer death rates are falling now by 1.1 percent per

year with black males showing the largest drop of 2 percent per year. For breast

and prostate cancer, death rates are now falling by 3.5 percent per year. Despite

overall progress, incidence and/or death rates for some cancers are rising. These

cancers, which include esophageal cancer, liver cancer, non-Hodgkin’s lymphoma,

acute myelogenous leukemia and melanoma, account for about 13 percent of the

total cancer burden in the U.S. The NCI has convened task forces and directed new

research to understand these trends.

The full and accurate assessment of the U.S. cancer rates is at the foundation of

our ability to define the cancer burden, detect trends and pinpoint geographic and

demographic variables and disparities. For 30 years, the NCI’s Surveillance, Epide-
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miology and End Results (SEER) Program has been the gold standard for cancer

registration worldwide. This year, we announced a major expansion including California, Louisiana, Kentucky and New Jersey, and SEER now covers 26 percent of

the U.S. population. We will increase the coverage of the rural population by 150

percent, of the population below the poverty line by 200 percent, of Asian Americans

by 200 percent, of non-Mexican Hispanics by 70 percent and of Native Americans

by 36 percent.

We have expanded and will continue to expand what we call Rapid Response

Studies which allow researchers and NCI staff to rapidly respond to urgent issues

that are revealed by cancer surveillance. We have greatly expanded our capacity to

monitor, report and evaluate geographic differences in cancer burden. This involves

a three-pronged approach. First, we are continually improving our analyses and dissemination of cancer mortality maps so that they are useful to researchers, local officials and policy makers. Second, we have provided a fund to encourage researchers

to propose hypothesis-testing studies associated with geographic variations in cancer. Third, we are greatly expanding the funding for and management of Geographic

Information Systems (GISs) to create computer systems that allow examination and

tracking over time and space of cancer rates with any geographically defined factor

that might contribute to the cancer burden. About 30 applications have been received in response to this new initiative.

EARLY DETECTION RESEARCH

New approaches, based on genomics, proteomics and other emerging technologies,

are being systematically pursued to reach the goal of developing effective and reliable tests for the earliest possible detection of all cancers and even of pre-cancers.

The Early Detection Research Network (EDRN) is a major new initiative of the NCI

to create, for the first time, a national R&D enterprise to discover biomarkers of

cancer, develop reliable tests and validate them with clinical studies. The EDRN is

a partnership between NCI, other government agencies, industry and academics; in

its first year, dozens of potential markers are being studied and three are moving

towards validation studies. The need to develop effective early detection for lung

cancer aimed at current and former smokers at risk for this deadly disease is clear.

We are actively pursuing the possibility that low dose, helical Computed Tomography might provide a new method to detect early and potentially curable lung cancers. A randomized trial to compare standard screening mammography with digital

mammography for the detection of breast cancer is being initiated and we continue

to closely monitor the results of NCI’s large randomized trial to finally determine

the clinical value of PSA in prostate cancer screening. Even our most successful cancer detection tool, the Pap smear, can use improvement. A recent NCI study has

addressed ways to make the test more predictive of serious findings for the large

number of Pap smears that are currently read as being of uncertain significance and

whose evaluation is estimated to cost as much as $1 billion per year. A DNA test

looking for the virus that causes cervical cancer can successfully predict which of

these Pap smears can be safely ignored and which require follow-up.

DIAGNOSIS

Two years ago, the NCI announced a major new program aimed at utilizing the

emerging knowledge of the genome to create new approaches to the diagnosis of cancer, indeed to potentially change the very names and classifications being applied

to human cancer. This program, called the Director’s Challenge, has been responded

to by a consortium of researchers from around the country who will attempt to redefine the classification of leukemia, lymphoma, lung, prostate, breast, colorectal,

brain, ovarian, childhood and other cancers. Results have begun to emerge demonstrating that cancers currently lumped under one diagnosis are actually multiple

molecularly distinct diseases. For at least one group of cancers called diffuse large

cell lymphoma, this previously hidden heterogeneity may explain why only 50 percent of patients can be cured with current therapy. Rather, it now appears that this

cancer is actually at least two different diseases, one of which is almost always

cured by current therapy and the other of which is almost never cured. This program will accelerate progress towards achieving a long-held dream of being able to

correctly classify human cancer.

MOLECULAR TARGETS: A NEW ERA IN THE DISCOVERY AND DEVELOPMENT OF

PREVENTIVE AND THERAPEUTIC AGENTS FOR CANCER

Revealing the actual molecular machinery of cancer has long promised to bring

a new, highly selective approach to both prevention and treatment. Examples of molecularly targeted therapy for cancer are beginning to emerge. For example, chronic
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myelogenous leukemia (CML) is known to be the result of the breaking and recombination of two chromosomes. The fused chromosomes produce a new gene which

tells the cell to produce a protein called bcr-abl whose uncontrolled activity is responsible for the growth of the leukemia cell. A new drug, called STI571, developed

as a collaboration between Novartis Pharmaceuticals and NCI-funded investigators,

is highly effective at turning off the activity of bcr-abl. In recently published studies,

virtually every patient with the chronic phase of CML, the disease expressing the

molecular target, has shown a complete correction of their blood abnormalities. This

is an oral drug with apparently few and mild side effects. We now know that this

same drug has activity against two other distinct molecular machines present in a

variety of cancers. As a result, the NCI in collaboration with Novartis is rapidly developing numerous clinical trials to test STI571, alone or in combination with other

drugs, in leukemia, gastrointestinal sarcomas (in which dramatic responses have already been seen), brain tumors, lung, prostate, breast, ovary and pediatric cancers.

To expand the discovery, validation and development of more molecular targets

in cancer, the NCI has initiated a series of funding programs including:

1. Molecular Targets Drug Discovery (MTDD) grants—four new grant programs

to discover and validate molecular targets for cancer for which we have received

over 170 applications.

2. Interdisciplinary Research Teams for Molecular Target Assessment (IRT/

MTA)—a new approach to the development of clinically useful assays to measure

and monitor cancer in patients according to the actual molecular targets where

treatment is directed.

3. Chemistry/Biology Centers—we have funded six centers of excellence to bring

chemists and biologists together to discover chemicals that report on and can perturb the molecular machinery of cancer.

This year we hope to establish one to three large contract efforts called National

Molecular Target Laboratories (MTLs). These are envisioned as genomic-scale efforts to discover molecular probes for all potential cancer relevant molecular targets.

We hope to expand the Rapid Access to Interventional Development (RAID) program, which was established two years ago to take potential therapeutics from academic or small business laboratories and turn them into drugs ready to be tested

in phase I clinical trials. In its first two years, RAID is supporting 51 novel agents

and we hope that 11 will reach the clinic by the end of this year.

The way scientific discovery eventually leads to advances in medical practice is

through the clinical trial. Currently, the NCI is actively accruing patients (about

25,000 a year) to over 840 clinical trials including about 700 early phase trials

where we can test the safety and possible effectiveness of new agents. In fiscal year

2000, 261 new trials were opened compared to 177 in fiscal year 1999. Our goal is

to double the number of new agents entering such clinical testing over the next two

years. Over the past year, completed clinical trials have demonstrated new treatment regimens that show a 50 percent increase in survival for resectable gastric

cancer and a 40 percent increase in survival rates for metastatic renal cancer, to

cite just two examples.

Over the past year, we have been implementing our strategic plan to address the

pressing question of cancer disparities through our Quality of Cancer Care initiatives, our newly formed Center to Reduce Cancer Health Disparities and our Comprehensive Minority Biomedical Programs. Eighteen Special Population Networks

for Cancer Awareness, Research and Training have been launched as have 12 new

partnership programs between NCI-funded Cancer Centers and Minority Serving

Institutions. These and other activities are aimed at increasing our understanding

of cancer disparities, increasing the participation of minority and underserved communities in the cancer research enterprise and finding ways to address the disparities in cancer burden.

I am pleased to present the President’s budget request for the National Cancer

Institute for fiscal year 2002, a sum of $4,177,203,000, which reflects an increase

of $439,275,000 over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.
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PREPARED STATEMENT OF CLAUDE LENFANT

Mr. Chairman and Members of the Committee: I am delighted to address this

Committee once again on behalf of the National Heart, Lung, and Blood Institute

(NHLBI). Let me begin by thanking you for your longstanding and generous support

of our research programs and activities, and highlighting two examples of the benefits that have accrued to the American public.

SICKLE CELL DISEASE

As the following illustration indicates, we have made tremendous progress in our

battle against sickle cell disease since our programs began about 30 years ago.

Patients with sickle cell anemia now live, on average, into their mid-forties, and

average life expectancy for patients with a related condition, SC-hemoglobin disease,

has climbed to the mid-sixties. These dramatic increases are highly correlated with

the development and fruition of key NHLBI research programs that have provided

an array of treatments and preventive regimens for the patients. Care that was once

fragmented and often administered in an emergency setting is now coordinated, beginning with screening of newborns, provision of appropriate control of infections,

and prevention of stroke in high-risk children through transfusion therapy.

Continued progress can be expected as we capitalize on new opportunities made

feasible by recent increases in the NHLBI budget. For instance, we have funded

studies of bone marrow transplantation in children with sickle cell disease. At least

50 children have undergone successful transplants, leading the way for further studies of this curative process. We have expanded our studies on the drug hydroxyurea,

which has been shown to decrease painful crises in adult patients by 50 percent,

to determine whether this may prove safe and effective in children, as well. Additional trials are also being initiated to determine how best to manage the long-term

care of children with sickle cell disease who are receiving chronic transfusions.

CONGENITAL CARDIOVASCULAR MALFORMATIONS

Congenital cardiovascular malformations are the most common birth defect in the

United States, affecting nearly one of 100 newborns, or about 40,000 infants each

year. While these malformations remain leading contributors to infant mortality,

the chances that an affected baby will live to celebrate a first birthday are far better

today than they were several decades ago. This progress, illustrated in the following

chart, is testimony to the success of research that has greatly improved our ability

to diagnose and treat congenital heart disease. Whereas a half-century ago, an accurate diagnosis could be made only at autopsy, nowadays many heart defects can be
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diagnosed in utero. Doctors no longer sit by helplessly as babies weaken and die,

because they now have an armamentarium of surgical and medical approaches, as

well as reliable and effective methods for monitoring and supporting these infants.

Nonetheless, many challenges remain, and we have expanded our research programs to meet them. Although we have enjoyed much success in treating congenital

cardiovascular malformations, their incidence has remained quite high and their appearance is often unexpected and unpredictable. Effective preventive strategies

await a better understanding of the genetic and environmental factors that influence heart development. In that regard, we are very pleased to have been able to

increase our program of Specialized Centers of Research (SCORs) in Pediatric Cardiovascular Diseases, which provides opportunities for basic and clinical scientists

to collaborate in unraveling complex problems such as this. During fiscal year 1999-

the initial year of the major expansion in our appropriations-we added two centers,

bringing us to a total of five.

During the current fiscal year, we are establishing a Pediatric Heart Disease Clinical Research Network to facilitate development and refinement of new treatment

protocols. This program will allow for rigorous evaluation of therapeutic regimens

for a wide variety of cardiovascular malformations, and promote rapid dissemination

of the findings to the medical community.

UNDERSTANDING HEALTH AND DISEASE

Over the years, I have emphasized the importance of a comprehensive approach

that looks at health and disease from a variety of perspectives. Good (or ill) health

rests on a tripod of genes, environment, and behavior. Let me provide some examples of NHLBI activities that address each of these issues.

GENETICS AND GENOMICS

The much-publicized sequencing of the human genome has brought with it tremendous excitement and opportunity. Coordinated efforts are already under way to

extend the range of fully sequenced animal models so that comparative genomics

can be used to identify human genes and to determine their functions. In this regard, the NHLBI has made a major investment in sequencing the genome of the

rat, which has great applicability to many of the diseases under our mandate. In

addition, intensive efforts are already under way to begin translating our knowledge

of the structure of the genome into a working knowledge of its functions. The new
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NHLBI Programs of Genomic Application, the largest Institute initiative in our history, are pursuing this goal with vigor and creativity.

The notion of using gene therapy to cure inherited diseases has long been a dream

of scientists, and in some areas such as hemophilia, we have every reason to believe

that it may soon become a reality. Our research in this area is gaining additional

momentum with funding of new Centers of Excellence in Gene Therapy, which are

designed to move these studies rapidly into the clinical arena within the context of

careful and appropriate safeguards for patient safety and welfare. Although gene

therapy is certain to continue to attract considerable interest, it is our belief that

the biggest public health payoff of our emerging genomic knowledge may lie in the

ability to understand individual differences in disease prognosis and treatment. We

are already seeing exciting reports of genetic variations that account for differences

in the manifestations and course of heart failure and differences in the effectiveness

of asthma medications. The ability to predict, for a given patient, whether disease

will be benign or severe and whether a drug will have beneficial or adverse consequences would truly revolutionize the practice of medicine.

EXTERNAL INFLUENCES

It has been said that one’s genes load the gun, but the environment pulls the trigger; that is certainly true in the case of many chronic diseases. Consider, for example, chronic obstructive pulmonary disease (COPD). Some smokers develop COPD

but many others do not, which suggests that genes influence individual susceptibility. However, the observation that very few nonsmokers ever develop COPD suggests that whether or not the genetic gun is loaded is irrelevant in the absence of

the environmental trigger-cigarette smoke.

In the area of asthma we are looking to environmental factors as a possible explanation for the startling increases in asthma prevalence, which have occurred over

too short a period of time for genetic factors to be the culprits. Research has produced some evidence that a more Westernized lifestyle that includes increased

household furnishings, humidity, and temperatures; decreased ventilation; and increased time spent indoors may result in greater allergic sensitization. A number

of studies have linked obesity with asthma in both adults and children, and burgeoning levels of overweight in the U.S. population are thought to be due, in part,

to decreased physical activity. Still other work has advanced the somewhat

counterintuitive hypothesis that modern lack of exposure to infections-because of

immunization, antibiotic use, or generally improved hygiene-may adversely affect

immune system development and lead to heightened susceptibility to asthma. We

are avidly pursuing these and other leads in the hope of uncovering some means

of stemming this rising public health problem.

BEHAVIOR

Understanding and changing health-related behaviors is critical if we are to make

the most of the new discoveries of the research enterprise. Behavior is, of course,

intimately connected with environmental exposure; inhaling smoke, consuming food,

and taking prescription drugs are all behaviors.

Our national education programs have been quite successful in increasing public

awareness and control of hypertension and high blood cholesterol, for example, but

there is still considerable room for improvement, especially in certain vulnerable

subsets of the population. To address this issue, the NHLBI recently established Enhanced Dissemination and Utilization Centers (EDUCs) as a means of extending the

health benefits associated with current clinical guidelines and medical information.

A total of 13 EDUCs have been established in communities at high risk for asthma

or cardiovascular disease. They are using information generated by the Institute’s

education programs to inform their communities of the public health burdens of

asthma and cardiovascular disease and to develop, implement, and evaluate educational strategies to reduce the burden. We believe this new approach will provide

a solid foundation for our efforts to address Healthy People 2010 performance objectives of eliminating racial/ethnic and geographic disparities in underserved high-risk

populations.

Our interest in this area encompasses not only the behavior of patients and the

general public, but also the behavior of health care providers who dispense advice

and prescribe medications. We are placing enormous emphasis on translation of new

research results into clinical practice. It is of great concern that the results of definitive clinical trials indicating, for instance, the proven benefits of lipid-lowering therapy in patients with high cholesterol or beta-blocker therapy for heart attack survivors have not been widely applied to patients. We are committed to using every
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avenue at our disposal to close this gap between bench and bedside and reap the

greatest public health return on our research.

AMOUNT OF PRESIDENT’S REQUEST

I am pleased to present the President’s budget request for the NHLBI for fiscal

year 2002, a sum of $2,567,429,000, which reflects an increase of $268,329,000 over

the comparable fiscal year 2001 appropriation.

GOVERNMENT PERFORMANCE AND RESULTS ACT

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

I would be pleased to respond to any questions that the Committee may have.

PREPARED STATEMENT OF DR. DONALD A. B. LINDBERG, DIRECTOR, NATIONAL

LIBRARY OF MEDICINE

I am pleased to present the President’s budget request for the National Library

of Medicine (NLM) for fiscal year 2002, a sum of $275,725,000, which reflects an

increase of $29,374,000 over the comparable fiscal year 2001 appropriation.

The Library is a key element in the foundation of the biomedical research enterprise. It is said that scientific research begins and ends in the library: from learning

about the latest that has been published before embarking on an experiment, to

publishing the results of that experiment in a journal that finds its way into an online database and onto the library shelf. In the health sciences, the institution that

plays the role of information collector, organizer, and disseminator is the National

Library of Medicine. The NLM not only maintains two buildings in Bethesda to

house this unparalleled resource (with treasures dating to the 11th century), but the

Library is the creator of immense electronic data resources that may be used, free,

by anyone in the world.

There is a second aspect of the NLM’s infrastructure role as creator, nurturer, and

backup for national and international medical information networks. The U.S. National Network of Libraries of Medicine, created by NLM in the sixties, is an organization of 4,500 member institutions that provide vital information services to American health professionals and, increasingly, to the public. NLM is encouraging medical libraries to work closely with public libraries and other community organizations to provide the public with access to high quality health information. The NLM

sponsors special programs within the network to support improving information

services in areas that disproportionately affect minority groups, such as HIV/AIDS

and toxicology and environmental health. There are also special outreach programs

within the network for Native Americans and Spanish-speaking minorities. The Library supports an international medical information-sharing network so that it can

both receive scientific information from foreign institutions and also provide their

researchers and health professionals with access to NLM’s electronic information resources.

Primary among these electronic resources is MEDLINE, the Library’s immense

database of references and abstracts to journal articles. With current usage of more

than 250 million searches a year, it is the world’s most-used medical literature resource. An easy-to-use Web-based program, known as PubMed, is the popular route

of access. It takes only a few seconds to search through an ever-expanding collection

of 11 million references and abstracts culled from more than 4,000 journals, covering the world-wide literature from 1966 to the present. The PubMed system also

has links to 1800 participating publishers Web sites so that users can retrieve full

text versions of articles identified in a MEDLINE search. A new feature, introduced

in 2001 by the NLM and the National Center for Complementary and Alternative

Medicine because of widespread public interest in the subject, is the ability to

search a database limited to the literature of alternative medicine ( CAM on

PubMed ). One unforeseen outcome of making MEDLINE available free on the Web

was that the database was discovered by the general public and quickly became a

favorite source of medical information. Today, the Library estimates that one third

of MEDLINE searching is done by consumers.
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BROADENING THE MANDATE

The enthusiasm with which the public embraced MEDLINE on the Web has altered the traditional role of the NLM, which was to serve the nation’s health by providing information services through health professionals, scientists, educators, and

practitioners. The Library maintains those time-honored services, but now also

serves the public directly with information products created specifically for consumers. MEDLINEplus and ClinicalTrials.gov are examples of Web-based services

that the public can access directly. The most broad-based of these is MEDLINEplus.

With help from members of the National Network of Libraries of Medicine across

the country, the information specialists who maintain MEDLINEplus select and organize a variety of consumer health information issued by the National Institutes

of Health, professional medical societies, and voluntary health agencies.

MEDLINEplus not only has extensive information on more than 425 diseases and

health conditions, but an extensive medical encyclopedia, detailed information about

prescription drugs, directories of health professionals and hospitals, health-related

articles from the daily news media, patient education modules, and links to a variety of organizations that disseminate information on various health problems.

MEDLINEplus also makes it easy for the consumer to search MEDLINE for up-todate information from the scientific literature. The Library is working with the National Institute on Aging to introduce more information related to the health of seniors, such as Alzheimer’s disease, and to put the information into a format that is

easily accessible by that segment of our population.

MEDLINEplus has become tremendously popular and now logs about 5 million

page hits per month. The NLM has also learned that health professionals of all

kinds are finding it to be an excellent source of information. Many physicians use

it to keep up-to-date on medical subjects outside of their specialty. Others are referring their patients to MEDLINEplus for up-to-date and authoritative information

about their health conditions.

One of the most useful features of MEDLINEplus is the ability to learn about

clinical trials. The Web site ClinicalTrials.gov, developed by NLM, became publicly

available in February 2000 and has already proved to be of great help to physicians,

patients, and their families. ClinicalTrials.gov is a registry of more than 5,000 federally and privately funded trials of experimental treatments for serious or life-threatening diseases or conditions. It is being expanded to include more clinical trials

sponsored by private companies and some performed in other countries. The database includes a statement of purpose for each clinical research study, together with

the recruiting status, the criteria for patient participation in the trial, the location

of the trial, and contact information. ClinicalTrials.gov is linked closely with

MEDLINEplus, so that anyone looking for information about a particular disease

or condition can easily tell it is the subject of any clinical trials. There is no registration for either MEDLINEplus or ClinicalTrials.gov, and complete privacy is assured

to all users.

SCIENCE ADVANCES

The National Library of Medicine’s involvement with the infrastructure of medicine extends far beyond its collection and the services built upon it. NLM is also

a leader in providing crucial components of medical infrastructure for the 21st century. One aspect of this is ensuring that the nation’s biomedical research enterprise

has the trained professionals it needs in computational biology, including mathematical modeling in the life sciences, advanced imaging, and molecular biology. This

role was brought into focus in the NIH report, The Biomedical Information Science

and Technology Initiative (BISTI), which recommends that the NIH invest heavily

in computer and information technology. As a result of BISTI, the NLM is expanding the 12 medical informatics training programs it supports at major universities

to carry out research in general informatics and in Medical Genomics.

The Library also has internationally recognized program in medical genomics, organized within the National Center for Biotechnology Information (NCBI). The

NCBI plays a pivotal role in coordinating, integrating, and disseminating the growing body of data currently being generated by the sequencing and mapping initiatives of the Human Genome Project. These efforts are complemented by the inclusion of individual genomic sequences, from over 75,000 organisms, submitted to

NCBI from scientists worldwide, as well as the data generated through the collaborative projects aimed at sequencing the genomes of other model organisms. NCBI

has also designed a novel system for linking its genomic resources to the biomedical

literature, a necessary step for providing quality assurance, as well as for providing

a framework for associating the most current and comprehensive biological information about a genomic sequence. Hence, NCBI’s readily accessible genomic and lit-
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erature databases, as well as their publicly available data analysis tools, represent

a true international information infrastructure designed to facilitate and propel the

biomedical research advances that will ultimately lead to better health for the

American public.

Because the NLM depends to a great extent on the Internet for disseminating its

many health information services, it is a supporter of the infrastructure initiative

known as the Next Generation Internet. This is a cooperative effort among industry,

academia, and government agencies that seeks to provide affordable, secure information delivery at rates thousands of times faster than today. Some NLM health

applications, for example those involving the Visible Humans and telemedicine, require more bandwidth and more reliable service than are currently available. The

Visible Human male and female data sets, consisting of MRI, CT, and photographic

cryosection images, are huge, totaling some 50 gigabytes. They are being used by

scientists around the world in a wide range of educational, diagnostic, treatment

planning, virtual reality, artistic, mathematical, and industrial uses. Projects run

the gamut from teaching anatomy to practicing endoscopic procedures to rehearsing

surgery. One new project, being carried out by NLM scientists, is AnatLine, a webbased image delivery system that provides retrieval access to large anatomical

image files of the Visible Human male thoracic region, including 3D images. Another is the collaborative project with other NIH Institutes to develop a super-detailed atlas of the head and neck. The Visible Human Project is an example of a

program that requires both advanced computing techniques and the capability of

the Next Generation Internet if it is to be maximally useful.

The Library also funds innovative medical projects that demonstrate the application and use of the capabilities of the Next Generation Internet. These projects span

the spectrum of medical disciplines, geographic areas, and target audiences. One example is to evaluate the potential of telemedicine applications on the health care

system in rural Alaska as a way of improving the quality of health care while at

the same time containing costs. Another project, in rural Iowa, is measuring the effectiveness of video consultations for patients with special needs, including children

with disabilities and persons with mental illness. In addition to supporting such advanced applications, the NLM continues its research on evaluating the performance

of today’s Internet pathways between and among health institutions and users. This

research gives us a glimpse into what the future holds.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to our goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

PREPARED STATEMENT OF ALAN I. LESHNER, PH.D., DIRECTOR, NATIONAL INSTITUTE

ON DRUG ABUSE

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute on Drug Abuse, a sum of

$907,369,000, which reflects an increase of $126,394,000 over the comparable fiscal

year 2001 appropriation.

NIDA’S COMPREHENSIVE PORTFOLIO

New scientific discoveries are fundamentally changing how this Nation approaches drug abuse and addiction. As we speak, more and more diverse patient

populations are receiving the best treatments that science has to offer as a result

of the work of our National Drug Abuse Treatment Clinical Trials Network. Promising new medications for treating addiction to nicotine, methamphetamine, cocaine,

heroin, and other drugs are being tested and developed further. And, our increasing

knowledge about the health and developmental consequences of drugs of abuse, particularly emerging drugs like Ecstasy (MDMA), is allowing us to rapidly provide

communities with the science-based tools to prevent and treat drug problems at the

local level. It is the tremendous advances from science, fueled in part by the very

generous increases in the past several budget cycles, that have allowed the National

Institute on Drug Abuse (NIDA) to accomplish these momentous achievements and

are providing us with renewed hope for a safe and healthy drug-free citizenry.

NIDA supports more than 85 percent of the world’s research on the health aspects

of drug abuse and addiction, including the impact that drugs have on other diseases

such as AIDS, hepatitis C, and tuberculosis. Because NIDA is so central to the entire research enterprise, the Institute maintains a very comprehensive research
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portfolio. We focus on all drugs abuse, both legal and illegal, including nicotine, with

the exception of a primary focus on alcohol. NIDA also rapidly translates all of its

new findings into formats that will be useful and used by a variety of audiences.

I will highlight some recent accomplishments and mention a few promising directions.

NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK

One of the best examples of the impact that science can have on local communities is in the treatment arena. Thanks to recent treatment advances, NIDA was

able in fiscal year 1999 to jump-start and then in fiscal year 2000 to greatly expand

what has quickly become a national clinical research infrastructure for testing

science-based drug addiction treatments in real-life community-based treatment settings. The result is that science-based treatments are now more accessible to diverse

groups of patients suffering from various addictions. Patients from across the country can now participate in the 7 research protocols that are already being run

through the National Drug Abuse Treatment Clinical Trials Network (CTN) with

another set of trials nearing the implementation stage. Until the establishment of

the CTN, researchers and treatment providers had to rely on treatment results from

studies conducted in specialized settings with much restricted subject populations.

Through this present network of 14 research centers and over 80 community treatment programs on the front lines of clinical practice across the country, the CTN

is engaging much of the drug abuse community in a national effort against addiction

and its consequences.

Additionally, the CTN provides a much needed infrastructure to more efficiently

and rapidly disseminate other kinds of research findings to practitioners and patients across the country. The CTN is a major step toward achieving NIDA’s millennial goal of improving the quality of drug addiction treatment in this country using

science as the vehicle. The network is still not complete, however. Many areas of

the country are yet to be brought into its auspices. Future plans call for the CTN

to spread out geographically which will better serve the more than 5 million individuals that the Office of National Drug Control Policy reports are currently in need

of treatment. The CTN will also serve as a natural vehicle to reach segments of the

population that have traditionally been the least likely to access medical help, such

as minority populations, disadvantaged populations, urban and rural communities,

and others whose health care needs are unmet.

RESPONDING TO EVER-EMERGING NEW DRUG PROBLEMS

Unfortunately, the overall picture of drug abuse in the United States is constantly

changing. As soon as we get a clear understanding of drug use patterns and gain

some control over existing drug problems, new dangerous substances seem to

emerge. Similar to the way a virus mutates, both regional and national drug abuse

patterns are constantly reshaping and rarely remain static. Tried and true prevention and treatment approaches may not work with many of the new drugs that are

emerging on the scene today. For example, newly emergent drugs like

methylenedioxymethamphetamine (MDMA or ‘‘Ecstasy’’), which acts as both a

hallucinogen and a stimulant, require new prevention and treatment approaches, as

does the unique stimulant methamphetamine. By having our pulse on these constantly changing drug trends, NIDA is poised to use the power of scientific research

and its application to avert emerging drug problems before they become national

epidemics. Nowhere is this proactive approach better exemplified than with the role

that science continues to play as our Nation discusses and responds to menacing

drugs like MDMA and methamphetamine. Because these club drugs were identified

early on by NIDA as potential health problems, we were able to launch our Club

Drug Research Initiative, and dissemination effort to rapidly inform communities

about these drugs. The fact that over 700,000 people have visited our dedicated

website on this topic (http://www.clubdrugs.gov/) since we launched it in late 1999

demonstrates the interest that people have in receiving science based information.

Not only have we come a great distance in educating the public about these drugs,

but our science has revealed some ground-breaking findings.

Research shows that ‘‘club drugs’’ such as MDMA are far from benign substances.

MDMA has been found in animals and most recently in humans to be neurotoxic,

resulting in long-lasting or possibly permanent damage to the neurons that release

serotonin. MDMA has also been found to impair an individual’s learning and memory abilities. Accumulating evidence shows that chronic heavy use of MDMA is associated with sleep disorders, depressed mood, anxiety, impulsiveness and hostility,

and memory loss. These cognitive effects have been found to last even up to six to

12 months after abstinence from the drug. Because of the abundance of research
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findings that continue to emerge on this topic, NIDA will bring leading researchers

from across the globe to the NIH campus this summer to discuss the myriad of findings and determine the best future research directions to answer important remaining questions about the causes and consequences of MDMA use and how best to deal

with them.

Methamphetamine, another popular club drug, has also been found to cause

neuronal damage to an individual’s brain cells, similar to some of the damage that

occurs from stroke or Alzheimer’s. Again, the abnormal brain function persists well

after drug use has stopped. For example, methamphetamine abusers who were

drug-free for up to eleven months still had significant memory and coordination deficiencies that were directly linked to brain changes produced by their prior drug use.

These alarming results have led NIDA to expand its portfolio in all areas, with a

special emphasis to look more closely at the potential health and developmental consequences that methamphetamine use by women of child-bearing years might have

on the developing child.

NEUROSCIENCE PORTFOLIO SETS STAGE FOR NEW TREATMENTS

The convergence and application of powerful new tools and emerging technologies

are accelerating the pace of neurobiological advances and allowing researchers to

ask and answer questions that were not even imaginable five years ago. NIDA has

nearly doubled the breadth and depth of its basic and clinical neuroscience portfolios. It has also allowed us to use basic research as the foundation for the entire

NIDA portfolio, from prevention efforts to medications development.

One of the major new areas that NIDA will exploit in the neuroscience arena is

to build on our knowledge about how specific brain circuits are affected by drugs

of abuse, so that we can more precisely determine how these brain pathways are

impacted by chronic exposure of drugs and how this can ultimately result in addiction. We have learned much, but still do not completely understand what causes an

individual to make the critical transition from being able to voluntarily use and

then abstain from drugs to the uncontrollable compulsive drug-seeking State that

has become the hallmark of addiction. An array of new technologies, such as microarrays, which can simultaneously analyze the activity of thousands of genes, is allowing us to better elucidate the molecular and cellular mechanisms by which voluntary drug use can evolve over time into addiction. We will be better able to determine what genes are being turned on and off by drug exposure and to identify patterns of gene expression that make some individuals more vulnerable to addiction

than others. For example, researchers found that individuals with a genetic deficiency in an enzyme that metabolizes nicotine (CYP2A6) are less likely to start

smoking, and smoke less if they do start, than individuals with normal CYP2A6 activity. Building on this knowledge, researchers tested more than 200 compounds to

decrease CYP2A6 activity and found that one compound (methoxsalen) commonly

used to treat skin disorders may be helpful to people who want to quit smoking.

This is just one example of the role that genetic research can play in helping us

to develop even more novel therapeutic approaches to prevention and treatment of

tobacco smoking.

Developing new approaches for treating addiction to nicotine is an important research endeavor for NIDA. NIDA will work both independently and collaboratively

to bring more pharmacological and behavioral therapies for nicotine addiction to fruition. NIDA is especially interested in developing treatments that are specifically

tailored to adolescent populations. At our Teen Tobacco Treatment Research Center

in Baltimore, for example, over 60 adolescent patients are participating in a 3-

month outpatient study that is helping to determine the most effective methods for

treating tobacco dependence in this population. These findings will be used to improve treatment for teens across the country.

SCIENCE-BASED PRINCIPLES FOR DRUG ABUSE PREVENTION

Just as NIDA has declared as our millennial goal to improve the quality of drug

abuse treatment nationwide using science as the vehicle, we are working to do the

same in the prevention arena. To ensure that science-based prevention principles

and protocols can be effectively used by a wide variety of populations across the

country NIDA plans to launch a National Drug Abuse Prevention Trials System in

fiscal year 2002. Leading prevention researchers will be brought together at NIDA’s

2nd National Conference on Drug Abuse to discuss the latest prevention findings

and to help NIDA prioritize the most promising prevention programs that should

be initially tested in the new System.
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BLENDING PUBLIC HEALTH AND PUBLIC SAFETY APPROACHES

In the same way that we have developed and sent to the field general principles

that define effective prevention and treatment strategies, we are working to lay out

standardized principles about duration, setting, and detailed protocols that should

be used to more effectively treat individuals while they are under criminal justice

control. Given the fact that untreated addicted criminal offenders have extremely

high rates of post-release recidivism both to drug use and to criminality, NIDA’s research can play a pivotal role in helping to address this public health and public

safety issue. As we continue to learn about how to improve treatment outcomes and

how to reduce the risk of relapse for patients undergoing treatment, NIDA will use

this knowledge to work with the Department of Justice and others to improve the

treatment of addicted criminals, particularly those with co-occurring mental disorders.

SCIENCE LEADS OUR NATIONAL DISCOURSE

Scientific advances continue to come at a tremendous pace and are not only improving the health and quality of life for our citizens, but are changing how we as

a Nation view and approach addiction. Understanding initial drug use as a voluntary, and thus preventable, behavior; and understanding addiction to be a treatable, often chronic and relapsing disease of the brain, forces us as a Nation to adopt

an even more sophisticated approach to dealing with this nation’s drug problems.

Having science set the stage for our course of action, including furthering the blending of public health and public safety approaches, is clearly the best way to reduce

the enormous financial and social burden of drugs on our society. There are indicators at all levels, Federal, State and local, that this is in fact occurring. NIDA will

continue to provide the latest science-based information to ensure the national discourse on this topic proceeds. We will also continue to ensure that new findings rapidly reach local communities. Science brings us all renewed hope and confidence for

a healthy and prosperous future. It is NIDA’s role to ensure that this hope for the

future is fully realized.

GOVERNMENT PERFORMANCE AND RESULTS ACT (GPRA)

NIH Budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

PREPARED STATEMENT OF DR. YVONNE T. MADDOX, ACTING DEPUTY DIRECTOR,

OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH

Mr. Chairman, Members of the Committee: I am pleased to present the President’s budget request for the Office of the Director (OD) for fiscal year 2002, a sum

of $232,098,000, which reflects an increase of $44,552,000 over the comparable fiscal

year 2001 appropriation. The OD provides leadership and coordination for the research activities of NIH, both extramural and intramural. The OD also is responsible for a number of special programs and for management of centralized support

services essential to the operation of the entire NIH.

The OD guides and supports research by setting priorities; allocating funding

among these priorities; developing policies based on scientific opportunities and ethical and legal considerations; maintaining peer review processes; providing oversight

of grant and contract award functions and of intramural research; communicating

health information to the public; facilitating the transfer of technology to the private

sector; and providing fundamental management and administrative services such as

budget and financial accounting, and personnel, property, and procurement management, administration of equal employment practices, and plant management services, including environmental and public safety regulations of facilities. The principal OD offices providing these activities include the Office of Extramural Research

(OER), the Office of Intramural Research (OIR), and the Offices of: Science Policy;

Communications and Public Liaison; Legislative Policy and Analysis; Equal Opportunity; Budget; and Management. This request contains funds to support the functions of these Offices.

The OD also maintains several trans-NIH offices and programs to foster and encourage research on specific, important health needs; I will now discuss the budget

requests for each of these trans-NIH offices in greater detail.
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THE OFFICE OF AIDS RESEARCH

The Office of AIDS Research (OAR) plans, coordinates and evaluates the NIH

HIV/AIDS research activities; serves as the focal point for AIDS policy and budget

development; and coordinates NIH involvement in international AIDS research activities.

OAR develops an annual comprehensive AIDS research plan and budget for all

NIH sponsored AIDS research, based on the most compelling scientific priorities

that will lead to better therapies and prevention of HIV infection and AIDS. These

priorities are determined through a unique and collaborative process involving the

NIH Institutes and non-government experts from academia and industry, with the

full participation of AIDS community representatives.

The OAR also administers a discretionary fund and supports the Intramural

AIDS Targeted Antiviral Program (IATAP) and the AIDS Research Loan Repayment

Program (LRP). The budget request includes $53.5 million for OAR activities in fiscal year 2002.

THE OFFICE OF RESEARCH ON WOMEN’S HEALTH

The Office of Research on Women’s Health (ORWH) is the focal point for women’s

health research at NIH and strives to ensure that research supported by NIH addresses the health concerns of women, that women are appropriately included as

subjects in research protocols and clinical trials, and that women are encouraged to

pursue careers in medical research. The science-based activities of ORWH are determined by the Agenda for Research on Women’s Health for the 21st Century, an

agenda developed following public hearings and scientific workshops involving some

1,500 representatives dedicated to improving the health of women. In fiscal year

2002, the OD budget request includes an increase of $28 million for ORWH to pursue the recommendations within this agenda including research on chronic diseases

in women, support for reproductive health research, research to aid in the prevention and detection of cervical cancer and ovarian cancer, studies to develop genderbased treatments for diabetes and kidney disease, and studies that address prevention and elimination of lung cancer in women. In addition, the ORWH, with NIH

Institutes and the Agency for Health Research and Quality (AHRQ), will support

career development programs that encourage the pursuit of interdisciplinary research careers relevant to women’s health and encourage patient-oriented or population-based clinical research careers. Finally, ORWH will continue to monitor compliance with established policies for the inclusion of women and minorities in clinical research.

THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

As NIH continues its efforts to improve health outcomes, there is increasing

awareness that many of our most serious health concerns are related to individual

behaviors and social context. The Office of Behavioral and Social Sciences Research

(OBSSR) furthers the mission of NIH by emphasizing the role that behavioral and

social factors play in health. The fiscal year 2002 OD budget includes $23.7 million

for OBSSR, an increase of $3 million, or 15.7 percent, over fiscal year 2000. OBSSR

works to integrate a psychological and social perspective across all research programs at NIH and to increase the support for behavioral and social science research

and training.

One strategy that OBSSR uses to increase support for behavioral and social

sciences research is the development of broad trans-NIH initiatives that address

issues relevant to many Institutes and Centers (ICs). OBSSR has addressed one of

the Nation’s most troubling health concerns—youth violence. A special panel of experts found that there is a need for interventions to prevent and treat youth violence, as well as for studies that would improve service delivery and maintain behavioral change. OBSSR, with four Institutes, initiated a Request for Applications

(RFA) entitled, ‘‘Research on the Development of Interventions for Youth Violence,’’

to focus on these needed areas of research.

Child neglect is one of the most critical areas of research when focusing on the

well-being of children, and a topic about which little is known. OBSSR authored

both a RFA and a Program Announcement (PA) for this activity along with six NIH

Institutes; the Agency for Children, Youth, and Families (ACYF); The Department

of Justice (DOJ), and the Department of Education. Both the RFA and the PA encourage research to enhance understanding of the causes, extent, treatment, management, and prevention of child neglect.

Enhancing opportunities to collaborate and form partnerships is an important

component of the OBSSR strategic plan. OBSSR is currently collaborating with the
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Association of American Medical Colleges (AAMC) to explore the development of a

curriculum for behavioral and social sciences relevant for medical schools. The

OBSSR, with several ICs, also supports centers to investigate aspects of the interactions between mind and body in health and disease. In addition, OBSSR has

joined with 12 Institutes to address the problem of inadequate adherence to prescribed medications and therapies.

THE OFFICE OF DISEASE PREVENTION

The Office of Disease Prevention (ODP) has several specific programs/offices that

strive to place new emphasis on the prevention and treatment of disease:

—In fiscal year 2002, the Office of Dietary Supplements (ODS) will continue to

promote the scientific study of the use of dietary supplements. The Office will

continue to support investigator-initiated research through the Research Enhancement Awards Program (REAP) and through PAs with other ICs at NIH.

The Office will also stimulate research through conduct of conferences, workshops, and presentations at national and international meetings.

—In continuing efforts to inform the public about the benefits and risks of dietary

supplements, the ODS expanded the International Bibliographic Information on

Dietary Supplements (IBIDS) database to include a consumer-oriented search

strategy.

—ODS is nearing completion of public-oriented information pages (Fact Sheets)

about specific vitamin and mineral dietary supplements for wide dissemination

in print and on the Internet. These are to be followed by a series of Fact Sheets

for botanical and herbal supplements which are being developed in conjunction

with the National Center for Complementary and Alternative Medicine

(NCCAM).

—To determine the effects and safety of dietary supplements containing ephedra,

ODS, with other Federal partners, will conduct an evidence-based review of

ephedra efficacy and safety; and will nominate ephedra for study by the National Toxicology Program of the National Institute of Environmental Health

Sciences.

Another component of ODP, the Office of Rare Diseases (ORD), supports research

activities on rare diseases and conditions, develops and disseminates information to

health care providers and patient support groups, and forges links among investigators with ongoing research activities in this area. The ORD continues to support

workshops and symposia to stimulate research and to identify research opportunities related to rare diseases.

The ORD, with the National Human Genome Research Institute (NHGRI), plans

to release a Request for Proposals (RFP) to establish an information center to respond to requests received by the NIH for information about rare and genetic disorders.

The ORD is also planning to respond to the critical needs of patients with rare,

life-threatening diseases by establishing a diagnostic center of excellence for patients whose previous diagnoses have been elusive despite extensive prior efforts to

determine the exact nature of their illnesses. The center would foster research on

rare diseases, develop facilities designed specifically for rare diseases research, and

would eventually support investigator training focusing on rare diseases.

OTHER OD ACTIVITIES

The OD also supports a number of additional NIH programs that promote research and enhance research career development:

—The NIH, through the OIR maintains intramural loan repayment and scholarship programs as important instruments for recruiting high quality candidates

in basic and clinical research positions. The request contains funds for the NIH

Clinical Research Loan Repayment Program and the Undergraduate Scholarship Program, both for individuals from disadvantaged backgrounds, and for the

General Research Loan Repayment Program. Each program provides for the

payment of educational costs in return for specific commitments of service in

NIH’s intramural research facilities. The request also contains funds for the implementation and administration of two new NIH clinical loan repayment programs, the Extramural Clinical Research Loan Repayment Program and the Pediatric Research Loan Repayment Program.

—The Office of Science Policy (OSP) has a role in addressing science policy issues

on behalf of NIH and in coordinating NIH’s approach to the Government Performance and Results Act (GPRA). In addition, the OSP has developed, with the

ICs, curriculum supplements to complement existing science curricula in grades
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K–12 that benefit both students and teachers and encourage students to consider careers in research.

—The request also reflects several functional transfers, including the transfer of

funding for bioengineering and bioimaging activities to the National Institute

of Biomedical Imaging and Bioengineering (NIBIB); funding for the Extramural

Loan Repayment Program transferred to the National Center for Minority

Health and Health Disparities (NCMHD); funding for the Extramural Associates Program (EAP) and the Extramural Associates Research Development

Award (EARDA) Program to the National Institute of Child Health and Human

Development (NICHD); and the transfer of the Academic Research Enhancement Award (AREA) funding to the several ICs supporting these awards.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

Thank you for giving me the opportunity to present this statement; I will be

pleased to answer questions.

PREPARED STATEMENT OF DR. JACK A. MCLAUGHLIN

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request of the National Eye Institute (NEI) for fiscal year 2002, a sum

of $571.1 million, which reflects an increase of $60.5 million over the comparable

fiscal year 2001 appropriation.

Diseases of the eye and disorders of vision can have a profound affect on the quality of our lives. Many of them are chronic, disabling diseases and conditions that

may ultimately lead to visual impairment or blindness. The National Eye Institute

and the scientists it supports are committed to improving the visual health of our

citizens. The research that they perform in this pursuit touches upon every area of

scientific endeavor and every facet of the visual system.

RETINAL DISEASE RESEARCH

The retina is the transparent, light-sensitive tissue that lines the back of the eye.

Diseases and disorders of the retina and its blood supply account for much of the

blindness and visual disability in this country. The most important of these include

macular degeneration, diabetic retinopathy, retinitis pigmentosa and related disorders, retinal detachment, uveitis, and cancer (choroidal melanoma and

retinoblastoma).

NEI-sponsored scientists are actively pursuing laboratory and clinical studies on

the development, molecular and cell biology, molecular genetics, and metabolism of

the photoreceptor cells that capture light; the initial neural processing of information that is transmitted to the visual centers of the brain; the pathogenesis of diabetic retinopathy; the fundamental causes of and etiologic factors responsible for

uveitis; the identification of the genes and neurodegenerative mechanisms for

macular degeneration, retinitis pigmentosa, and related disorders; and the cellular

and molecular events that accompany retinal detachment. The ultimate goal of

these studies is to develop effective therapeutic or preventive measures where none

currently exist or to improve those treatments that are currently available.

CORNEAL DISEASE RESEARCH

The cornea is the transparent tissue at the front of the eye that plays an important role in refracting or bending light to focus visual images sharply on the retina.

Because the cornea is the most exposed surface of the eye, it is especially vulnerable

to damage from injury or infection. The leading causes of corneal blindness are herpes and other infections, corneal opacification or clouding, and inherited and degenerative diseases. The NEI supports laboratory and clinical studies on a wide range

of research topics, including: the regulation of genes that express proteins unique

to corneal tissue; the characterization of specific proteins and cell surface receptors

that interact with corneal cells, pathogens, and blood-borne cells; the mechanisms

that maintain corneal hydration and transparency; the physiologic basis for immune

privilege in the cornea; corneal wound healing; the cellular and molecular mechanisms by which corneal transplants are rejected; and the role of specific viral genes

in the establishment and reactivation of corneal herpetic infections. These studies
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should ultimately improve our ability to limit or prevent damage to corneal clarity

caused by injury, infection, or other disease processes.

CATARACT RESEARCH

A cataract is an opacity of the eye’s normally clear lens that interferes with vision. Cataract may develop at any time during life, although it is most often associated with advancing age. In addition to aging, cataract may be a consequence of diabetes and other metabolic disorders, trauma, exposure to ionizing radiation, or it

may be inherited or congenital in nature. Cataract treatment in this country is one

of the most successful of all surgical procedures. At this time, surgery to remove the

opaque lens is the only effective way of treating cataract.

The NEI-sponsored research includes: studies of the development and aging of the

normal lens of the eye; the identification, at the cellular and molecular level, of

those components that maintain the transparency and proper shape of the lens; the

control of lens cell division and differentiation; the delineation of the structural and

regulatory sequences of crystallin and noncrystallin lens genes; and the impact of

continual oxidative insult on the lens. The aim of this research is to develop the

means to delay or prevent cataract formation.

GLAUCOMA RESEARCH

Glaucoma is a group of disorders that share a distinct type of optic nerve damage

that can lead to blindness. Glaucoma is often associated with increased pressure

within the eye caused by inadequate drainage of aqueous humor, the fluid within

the eye that nourishes the cornea and lens. Researchers once thought that glaucoma

resulted solely from increased pressure, but they now know that the elevation in

the pressure within the eye is only one of the risk factors for the disease. Although

glaucoma is primarily a chronic disease of aging, it may occur at any age. It can

occur as a primary disorder or it can be secondary to other ocular or systemic conditions. Because glaucoma is a major health problem and the number one cause of

blindness in African-Americans, it is a primary focus for NEI’s research on health

disparities. Approximately three million Americans have glaucoma, with about half

of these unaware that they have the disease. As many as 120,000 are blind from

this disease.

The NEI supports clinical trials that assess the role of medical and surgical therapy in the treatment of the disease. One study, the Ocular Hypertension Treatment

Study, is attempting to determine the benefit of treating people with elevated pressure in their eyes who are at moderate risk for developing glaucoma with pressure

lowering medications to prevent or delay sight-threatening damage to the eye from

glaucoma. The NEI also supports studies on the identification and characterization

of genes that are involved in the development of glaucoma and the basic mechanisms that control fluid secretion and outflow and the design of methods to control

these processes and to protect the optic nerve from damage.

STRABISMUS, AMBLYOPIA, AND VISUAL PROCESSING RESEARCH

Research on strabismus and amblyopia encompasses a broad range of clinical and

laboratory studies on the structure and function of the neural pathways from the

retina to the brain, the central processing of visual information, visual perception,

the control of ocular muscles, and refraction. A large number of congenital, developmental, and degenerative abnormalities affect the visual sensorimotor system, but

three disorders are of primary concern: strabismus or the misalignment of the eyes;

amblyopia, or lazy eye, in which one eye has reduced vision due to misalignment

or unequal refraction; and refractive errors, especially myopia (nearsightedness), hyperopia (farsightedness), and presbyopia (difficulty focusing on near objects with advancing age).

As a means of improving the visual health of those afflicted with these conditions,

the NEI supports a broad range of laboratory, therapeutic, and preventative studies

that are concerned with the development and function of the neural pathways from

the eye to the brain; the central processing of visual information; visual perception;

optical properties of the eye; oculomotor function; functioning of the pupil; and control of the ocular muscles. Additional emphasis is on research on optic neuropathies,

eye movement disorders, and the development of myopia.

VISUAL IMPAIRMENT AND ITS REHABILITATION

Each of the chronic diseases and disorders previously described can cause blindness and lesser degrees of visual impairment that may also be disabling. As a

means of addressing the special needs of those with uncorrectable visual impair-
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ment or low vision, the NEI supports a program of research on visual impairment

and its rehabilitation. Some individuals require simple optical or mechanical aids

to perform daily functions adequately, while others may need more specialized devices or modifications to their environment. Many face depression as they deal with

their loss of vision and potentially their loss of independence.

The NEI supports research to understand the origins of visual impairment and

assist in the rehabilitation of those who have such disabilities. The NEI supports

projects aimed at improving the methods of specifying, measuring, and categorizing

loss of visual function; devising strategies to help visually impaired people maximize

the use of their residual vision; systematically evaluating new and existing visual

aids; developing an adequate epidemiological base to understand the causes of blindness, partial loss of sight, and visual anomalies; and studying the optical, electronic,

and other rehabilitative needs of people with visual impairments.

HEALTH EDUCATION AND COMMUNICATION

The NEI’s National Eye Health Education Program (NEHEP) was developed to

increase awareness among health care professionals and the public of scientifically

based health information that can be applied to preserving sight and preventing

blindness. Working through its partnership of over 50 professional and voluntary organizations, which includes some of the other NIH Institutes, the NEHEP attempts

to reach select target audiences, informing them of the importance of early detection

and treatment of eye diseases, particularly glaucoma and diabetic retinopathy, and

persuading them to make an appropriate change in behavior.

To increase awareness of low vision and its impact on quality of life, NEHEP developed the Low Vision Education Program. This program is directed toward people

with low vision, their families and friends, and the health care and service professionals who care for them. It takes particular note of the growing population of people over age 65 and other high risk populations, including Hispanics and African

Americans who are likely to develop low vision at an earlier age. As part of this

education effort, the NEI has developed a public service campaign and a mobile exhibit on low vision that is currently traveling to shopping malls and centers

throughout the United States. The exhibit consists of five colorful kiosks designed

to attract a cross section of the population. It contains an interactive multimedia

touchscreen program; provides information on low vision services and resources; and

displays aids and devices that help people with low vision, all available in Spanish

as well as English. The exhibit and touchscreen program explain the causes of low

vision; offer personal accounts of people living with low vision; and provide a selfassessment to help people determine if they or someone they know may have low

vision.

GOVERNMENT PERFORMANCE AND RESULTS ACT

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

Mr. Chairman that concludes my prepared statement. I would be pleased to respond to any questions you or other members of the committee may have.

PREPARED STATEMENT OF KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF

ENVIRONMENTAL HEALTH SCIENCES

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Environmental Health Sciences

(NIEHS) for fiscal year 2002, a sum of $561,750,000, which reflects an increase of

$58,668,000 over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.
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GENES AND THE ENVIRONMENT

Over the past 100 years, advances in biomedical research have led to remarkable

improvements in the prevention, diagnosis, and treatment of human illness. Life expectancy has increased from an average age of 49 years at the turn of the century

to the current average of 76. Continued improvements in quality of life and longevity will require a better understanding of the development and progression of

common diseases. Identification of the major determinants of human health is one

of the major challenges of the 2lst century.

Scientists in biomedicine, environmental health, and public health are working to

understand and prevent human diseases. Most chronic diseases in humans arise

from a complex array of factors which could include several genes, environmental

conditions or exposures, the age, nutritional status or stage of development of a person, and other predisposing factors. The relationship between genes and the environment can be compared to a loaded gun and its trigger. A loaded gun by itself

causes no harm; it is only when the trigger is pulled that the potential for harm

is released. Genetic susceptibility creates an analogous situation where the loaded

gun is one or a combination of susceptibility genes and the trigger is an environmental exposure. One can inherit a predisposition to have a disease, but never have

the disease unless exposed to the environmental trigger. Therefore, most chronic

diseases will not be fully understood until both the genetic and environmental contributions to their etiology are elucidated. Unfortunately, the relationship between

genes and the environment is neither well understood nor extensively studied at the

present time. Until recently, limited and inadequate knowledge of human genetics

had hampered progress in this area and had limited scientists to relatively simplistic models-models that assume that diseases are caused by mutations in a single

gene or by exposure to a single environmental agent. Interactions between multiple

genes, or between genes and several environmental agents, have only been rarely

considered as the cause of human illness. So our knowledge has many information

gaps.

To develop the framework that will allow us to accurately assess environmental

threats to human health-threats that affect us from conception to death-we need to

fill in the missing information in at least three areas. We need:

—information relating to toxicity for environmentally significant compounds from

well-characterized animal models tested at biologically relevant doses;

—a comprehensive catalogue of human gene variation that can influence susceptibility to environmental exposures;

—extensive epidemiological and other population-based studies that can definitely

link human disease to environmental exposure.

ASSESSMENT OF TOXICITY/CARCINOGENICITY

Estimates are that 70–75 percent of the high-volume, high-use chemicals (15,000)

in commercial use in the United States have not been assessed for human toxicity

or carcinogenicity (National Academy of Sciences, 1980; Environmental Defense

Fund, 1993). While many, if not most, of these may not require testing since they

are very similar to chemicals already tested, several do need testing. But, given the

sheer magnitude of the problem, we can never satisfy this testing requirement using

traditional technologies. For example, the National Toxicology Program only recently celebrated the completion of carcinogenicity assessments of 500 chemicals

after 30 years of operation. The time-honored way of determining which of the thousands of environmental agents are toxic to humans is to expose hundreds of animals

to the suspected product and observe them for adverse health outcomes (e.g., cancer

or developmental anomalies). These studies take years to complete, cost millions of

dollars, use hundreds of animals, and are not sufficiently informative.

Now, however, we have new tools generated by advancements in the science of

genomics; that is, the study of our genes and what they do. These tools offer unprecedented ways to understand biological and disease processes at the molecular level.

The NIEHS is merging the field of toxicology with genomics, creating a science of

toxicogenomics that identifies toxicant activity at the genetic and molecular level.

Last November, the NIEHS developed a National Center for Toxicogenomics to promote a genomics-based approach for assessing the toxic or carcinogenic potential of

environmental agents. Using this approach, one can survey the entire human genome in just a few days to determine the response of various tissues or organ systems to specific environmental exposures. Rather than using pathology to identify

illness, the toxicogenomics approach relies on gene expression profiles or signature

patterns to determine which agents are toxic or carcinogenic. Current experience

with this rapidly evolving technology has validated its potential usefulness in that
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various classes of toxic agents give rise to unique signature patterns (i.e., gene expression profiles) characteristic of specific disease pathways.

To promote the development and validation of the gene expression profiling approach, the NIEHS has established five university-based regional centers with the

NIEHS intramural program serving as a data repository and coordinating center.

SEARCH FOR ENVIRONMENTAL SUSCEPTIBILITY GENES

Organisms and species are exposed to hazardous agents in the environment on

a continual basis. As a result, sophisticated metabolic pathways have evolved that

can minimize the biological consequences of hazardous environmental agents. These

pathways constitute the so-called ‘‘environmental response machinery.’’ All human

genes, including those that encode components of the environmental response machinery, are subject to genetic variability, which can be associated with altered efficiency of a biological pathway. So a person’s risk for developing an illness as a result

of an environmental exposure might be dependent on the efficiency of his or her own

unique set of environmental response genes. These genes, for example, might determine how a person responds to and metabolizes drugs or carcinogenic compounds

after exposure.

The Environmental Genome Project was initiated in 1997 to stimulate populationbased and other research into the role of genetic variation in response to environmental exposure. The key objective is to identify all the genes in the human genome

that confer susceptibility to environmental agents. The NIEHS is supporting five

university-based centers to resequence suspected or candidate environmental susceptibility genes to identify genetic variations responsible for differences in response

to environmental agents leading to specific diseases.

Presently, environmental health regulatory agencies craft rules as if ‘‘one-size-fitsall.’’ However, we know that individuals can vary by more than two-thousand fold

in their capacity to repair or prevent damage following exposure to toxic agents in

the environment. For example, several people died after members of the Aum

Shinrikya cult released potent nerve gas called sarin in a Tokyo subway station

about six years ago; not all those exposed, however, died. We now know that some

humans are much more vulnerable to sarin poisoning than others. Circulating in

the blood of 25 percent of Asians and 10 percent of Caucasians is a version of an

enzyme called paraoxonase that converts sarin to a less toxic chemical about 10

times more quickly than the enzyme found in most people. The gene that produces

paraoxonase is one of dozens that toxicologists think make some individuals more

or less susceptible to the effects of pollutants and other environmental chemicals

(e.g., organophosphate pesticides), contributing to adverse health outcomes such as

cancer, asthma, birth defects, diabetes, cardiovascular disease, Parkinson’s and Alzheimer’s. So, scoring for variations in a person’s genetic code can help determine the

likelihood that an individual will have an adverse response from exposure to sarin

or other environmental agents. Knowledge of the prevalence of susceptibility genes

would take much of the guesswork out of environmental health decision-making.

GENETIC VARIABILITY, EXPOSURE, AND DISEASE ASSOCIATION

To study the functional implications of genetic polymorphism or variation relative

to specific environmental exposures and disease development, better exposure data

will be required. Exposure monitoring is a ‘‘right-to-know’’ issue for citizens who are

involuntarily exposed to environmental pollutants. However, little is known about

actual human exposure and body burdens of environmental pollutants. This knowledge gap hampers regulatory decision making and introduces uncertainties in setting exposure limits. It also limits our understanding of dose-response relationships

and capacity to develop effective prevention strategies. Exposure is typically estimated using indirect surrogates of environmental quality, such as toxic release and

production inventories and environmental monitoring. Actual exposure is highly

variable for individuals and subpopulations. It is really a function of individual uptake, metabolism, excretion and behavior. So the assumption that all men, women

and children living in the same geographic area have similar exposure is seriously

flawed. What we need are direct measures of exposure based on tissue analysis or

deposition. The NIEHS is spearheading an interagency effort to intensify exposure

assessment research. We have been working with Centers for Disease Control and

Prevention to expand the types of toxicants measured in samples collected thru National Health and Nutrition Examination Survey (NHANES) such as those recently

reported in the National Report on Human Exposure to Environmental Chemicals.

These and future efforts are expected to strengthen what is often viewed as the

weakest link in the risk assessment process.
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The effects of exposure are not just limited to individual chemicals. Typically, toxicity and carcinogenicity are assessed in animals one chemical at a time, and the

risk for each chemical in the mixture is added up to get a total risk. Implicit in summing up the risks is the assumption of independent, not interactive but additive,

effects. This assumption is controversial. Also, this contrasts with the ‘‘real world’’

where humans are exposed to multiple agents-chemical, physical and biological-at

any given time in the form of mixtures. We are aware of situations where current

assumptions do not hold in that components of mixtures behave synergistically. We

now have the capacity to develop technology to assess the toxicity of mixtures. One

promising technology being developed with the NIEHS support is the DNA

microarray gene expression profiling approach described above.

SUMMARY

Much of 20th century medicine focused on managing endstage diseases rather

than preventing them at the outset. Yet prevention is the most cost-effective and

life-enhancing means we have to protect human health at every life stage. In the

past, the environmental health sciences, where prevention is the goal, lacked the

necessary tools to identify important disease triggers. Now, however, the Nation’s

long-term investment in the basic sciences has put us in the position to fill the

knowledge gaps. We are poised to more efficiently and more precisely identify the

environmental components that set the stage for disease initiation and progression.

PREPARED STATEMENT OF AUDREY S. PENN

Mr. Chairman and Members of the Committee: I am Audrey Penn, Acting Director of the National Institute of Neurological Disorders and Stroke. I am pleased to

present the President’s budget request for NINDS for fiscal year 2002, a sum of

$1,316,448,000, which reflects an increase of $139,428,000 over the comparable fiscal year 2001 appropriation. The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) Of

1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal year 2000 results to the goals in our fiscal year 2000

performance plan. As performance trends on research outcomes emerge, the GPRA

data will help NIH to identify strategies and objectives to continuously improve its

programs.

The mission of NINDS is to reduce the burden of neurological disorders. Today

I will speak briefly about that burden. I will also say a few words about the progress

so far in treating these diseases and the remarkable opportunities presented by recent scientific advances. However, I will spend most of my limited time telling you

what NINDS is doing to ensure that science is translated as quickly as possible into

help for people with neurological disorders.

THE BURDEN OF NEUROLOGICAL DISORDERS

Disorders that affect the brain, spinal cord, nerves of the body, muscles and their

control impose an enormous toll on society. Neurological disorders can compromise

the complex thinking and emotions that make us human, the routine perception and

movement that we take for granted, and even the control of bodily systems that are

normally beneath our conscious awareness. Trauma, infections, toxic exposure, birth

defects, degenerative diseases, tumors, gene mutations, systemic illness, vascular

events, nutritional deficiencies, and adverse effects of essential treatments for diseases like AIDS and cancer can all disrupt the functions of the nervous system.

We often think first of neurological disorders that afflict older Americans-stroke,

Alzheimer’s, Parkinson’s. But problems like multiple sclerosis, brain and spinal

trauma usually strike young adults, and the list of childhood disorders is enormousautism, cerebral palsy, Duchenne muscular dystrophy, Batten disease, Canavan disease, to name just a few. Disorders like epilepsy and brain tumors, which can strike

at any age, also occur frequently.

Some neurological disorders are very common. NINDS and American Heart Association studies show that more than 700,000 Americans suffer strokes each year.

The Centers for Disease Control and Prevention estimates that head trauma kills

more than 50,000 people each year and more than five million survivors suffer disabilities. Physicians tell us that pain is the most common symptom that brings people to a doctor. A recent journal from the American Academy of Neurology, for example, suggests that migraine headaches affect about twenty percent of women. Diabetic neuropathy commonly accompanies diabetes. Epilepsy, autism, cerebral palsy,
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dystonia, the neurological aspects of AIDS and several other disorders also affect

many people.

Collectively the hundreds of rare disorders of the nervous system also affect many

people and their families. The history of medicine teaches us that studying rare diseases often has wide repercussions. Creutzfeldt-Jakob disease (CJD) is a terrible

disorder that strikes about one in a million people. The long tradition of NINDS research on this formerly obscure disease is now coming to the forefront because of

the public health concerns raised by the related bovine spongiform encephalopathy

(BSE or ‘‘mad cow disease’’). In the last year NINDS initiated a contract program

to develop tests needed for confronting the public health and economic threats from

BSE. Rare disorders often provide clues to more common diseases, and CJD is a

good example here too. Abnormal aggregation of proteins called prions are at the

crux of CJD. Abnormal clumps of other proteins have also been implicated in common diseases such as Parkinson’s, Huntington’s, and Alzheimer’s.

PROGRESS AND PROMISE IN NEUROLOGICAL DISEASES

Perhaps because the brain is so complex and inaccessible, neurological disorders

have always been among the most difficult to treat of all medical problems, but we

are making progress. The American Heart Association estimates that the death rate

from stroke went down by 14 percent from 1987 to 1997. NIH is continuing prevention trials that have contributed to that decline. In the 1990’s NINDS clinical trials

demonstrated the first acute treatment that improves outcome from stroke, the drug

t-PA, and the first emergency drug treatment that can reduce the disability from

spinal cord injury, high dose methyprednisolone. Neurosurgeons have developed

guidelines that can improve outcome from head trauma. The first treatments that

reduce symptoms and even slow progression of multiple sclerosis have emerged from

studies of the nervous and immune systems. Several new drugs for epilepsy are now

available, partly through efforts of the NINDS drug development programs. New

surgical treatments, such as chronic deep brain stimulation, show promise for Parkinson’s and other disorders. We have new genetic tests that help diagnose inherited neurological disorders. Clearly we are making progress, and much of that

progress rests on the stream of advances from basic neuroscientists which is continuing. But each example represents only the first steps toward adequate treatments and prevention. We have a long way to go.

What is most encouraging is the range of new therapeutic strategies on the horizon. It may seem peculiar, but one important step in learning how to prevent or

cure a disease is to first learn how to cause it. The striking progress in understanding the nervous system and its diseases at the level of genes, proteins, cells

and brain circuits, is bringing us long sought after animal models of human disorders. Animal models enable scientists to follow the course of disease progression,

refine understanding of causes, and develop therapies. Discovery of the genes responsible for inherited disorders such as Batten disease, ataxias, spinal muscular

atrophy, and muscular dystrophy often leads to animal models of these disorders.

Finding the genes responsible for uncommon inherited forms of Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS) has led to animal models that will foster progress against the more common non-inherited versions of these disorders.

Genes are not the only route to developing animal models. This year brought new

models for neurodegeneration in Parkinson’s disease through use of a pesticide, rotenone, as well as through manipulation of genes; surgical techniques have always

been important for developing animal models of stroke and trauma; and

immunological approaches are important in diseases such as multiple sclerosis.

Using animal models, researchers are exploring the potential of cell transplantation, gene transfer, natural biochemicals, electrical stimulation, and new approaches to drug therapy for treating neurological disorders. Researchers using gene

transfer vectors to deliver the natural neurotrophic (growth and survival) chemical

GDNF were able to counter some Parkinson’s-like effects in animals. Gene transfer

also has shown promise in mice with the same gene defect as boys with Duchenne

muscular dystrophy, and strategies to repair defective genes also now appear plausible for this disease. Cell transplantation in animals has helped repair damage

from spinal cord injury, restore the myelin insulation of nerve fibers that is lost in

multiple sclerosis, provide missing enzymes in inherited disorders like Tay-Sachs

disease, and replenish the chemical dopamine in Parkinson’s disease. Study of the

steps in ‘‘cell suicide’’ that occurs as the simple nervous system of the worm develops led to the recognition that similar cell death mechanisms play out in several

neurological disorders. Blocking steps in this cell death program has shown benefits

in animal models of stroke, trauma, Huntington’s disease and ALS. This is only a
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sampling, but shows that not far over the horizon are possibilities for treating many

neurological disorders.

WHAT IS NINDS DOING TO MOVE TOWARD CURES?

The genius of the NIH system is its power to engage the collective wisdom and

ingenuity of the nation’s scientific community. We must continue to nourish those

ongoing efforts and position ourselves prudently to continue to support that base

upon which all our efforts rest. At the same time, the scientific progress compels

us to target efforts toward translating the scientific potential into real help for people as quickly as possible, and the recent funding increases empower us to do so.

The key is again to rely upon the distributed insight of the medical and scientific

community.

NINDS has a multi-tiered planning process to harness that collective wisdom to

meet our mission. The planning process brings together scientists, physicians, the

advocacy community, industry, and NIH staff in several complementary ways. We

began, about two years ago, by convening more than 100 leaders from the scientific

community, together with patient-advocates and NINDS staff, to assess needs, opportunities and priorities in several cross-cutting areas, each relevant to progress

against many disorders. Seven panels focused on Neurogenetics; Neurodegeneration;

Channels, Synapses, and Circuits; Cognition and Behavior; Neurodevelopment; Plasticity and Repair; the Neural Environment; and Experimental Therapeutics and

Clinical Trials. NINDS posted draft panel reports on the internet and solicited comments from more than 250 patient advocacy groups and professional scientific organizations. This input helped shape the NINDS strategic plan ‘‘Neuroscience at the

New Millenium.’’ which serves as a foundation for all our planning efforts.

Building on the strategic goals, we have begun a series of disease specific planning efforts, beginning with Parkinson’s disease. A January 2000 workshop brought

together intramural, extramural, and industry scientists, Parkinson’s disease advocates, and ethicists, forming the basis for the ‘‘NIH Parkinson’s Disease Research

Agenda,’’ submitted to Congress in March of last year. NIH is vigorously implementing the Agenda. We held several workshops focused on specific aspects of Parkinson’s disease research, such as drug therapies, gene therapies, cognitive and

emotional aspects, and environmental influences. Including solicitations issued

shortly prior to the Agenda or nearing release, NIH has developed more than a

dozen requests for grants or contracts that target specific Agenda priorities. Targets

of opportunity include deep brain stimulation, clinical trials for neuroprotective

drugs, and proteins implicated in the disease. We have supplemented existing

grants to expedite work on high throughput drug screening, bringing new investigators to the field, and genetics of Parkinson’s in minority ethnic groups. Working

groups or consortia have formed in critical areas, such as deep brain stimulation.

NINDS is also continuing to support the eleven Udall Parkinson’s disease research

centers. The Institute will soon launch a website that will set the standard for informing the public about progress in implementing a disease specific research plan,

and also serve as a resource for researchers and caregivers.

Several other disease specific planning efforts are also underway. As a joint undertaking NCI and NINDS brought together a Progress Review Group on Brain Tumors. More than 100 experts in several scientific and medical disciplines with a

bearing on brain tumors presented assessments of current understanding and future

needs in 14 critical areas. NINDS and NCI are working to implement these recommendations. A Progress Review Group in Stroke is following a similar process.

Last spring’s landmark conference ‘‘Curing Epilepsy: Focus on the Future’’ launched

efforts that developed ‘‘benchmarks’’ for epilepsy research which are the first step

towards a research agenda. This spring the Institute of Medicine of the National

Academy of Sciences released an assessment of current status of research on multiple sclerosis with recommendations for future research. This effort, which included

NIH researchers, will inform future efforts on this disease. Disease specific planning

efforts dovetail with the NINDS strategic plan, revealing elements in common for

many diseases and those unique to each disorder.

Health disparities has also been a focus of specific planning efforts at NINDS.

Since fiscal year 1999 NINDS, working together with NCRR, the ORMH and other

Institutes, has expanded its original center at Morehouse School of Medicine to

eight specialized neuroscience research programs at minority institutions and a network of research consortia at 28 leading neuroscience research programs. NINDS

is expanding activities of this program with a parallel development of other research

as an integral part of the Institute plan for addressing health disparities.

Another aspect of NINDS planning efforts is an active agenda of scientific workshops, often held in cooperation with private groups and with other components of
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NIH, such as the Office of Rare Diseases. NINDS holds about 40 of these meetings

each year. Some focus on specific therapeutic strategies or technologies, such as neural prostheses, gene therapy, optical imaging, computational neuroscience and high

throughput drug screening. Others target specific diseases. Recent workshops focused on Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy,

hereditary spastic paraplegias, spinal cord injury, ALS and spinal muscular atrophy,

channelopathies, neurofibromatosis, and pediatric stroke. At these workshops, in addition to the scientific discussions, NINDS solicits advice on how to eliminate bottlenecks and encourage progress.

I could describe many other planned and ongoing activities, and certainly more

exciting science, but I want to conclude with a simple message. Because NINDS has

an ‘‘acting’’ director does not mean the Institute will be less active until a permanent director is appointed. Given the burden of neurological disorders, the scientific

opportunities, and the favorable funding environment, it would be unconscionable

for the Institute to become passive. I assure you we are doing everything we can

to move aggressively toward better ways to treat and prevent neurological disorders.

Thank you. I would be happy to answer questions.

PREPARED STATEMENT OF JOHN RUFFIN, PH.D., DIRECTOR, NATIONAL CENTER ON

MINORITY HEALTH AND HEALTH DISPARITIES

Mr. Chairman and Members of the Committee: I am honored to appear before you

as the new Director of the National Center on Minority Health and Health Disparities (NCMHD) to present the President’s budget request for fiscal year 2002, a sum

of $158.425 million, which reflects an increase of $26.356 million over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

The Secretary for Health and Human Services approved the NCMHD on January

16, 2001, as called for in Public Law 106–525. Within the National Institutes of

Health, the NCMHD serves as the focal point for planning and coordinating minority health and other health disparities research. The Center coordinates the development of a comprehensive health disparity research agenda that identifies and establishes priorities, budgets, and policy that govern the conduct and support of all NIHsponsored minority health and other health disparities research and training activities. Significant progress has been made since the establishment of the Center; however, considerable work remains to be done as the Center transitions from an Office

to a Center and assumes grant review, funding and financial management functions. The development of a comprehensive research portfolio began with the NIH

Office of Research on Minority Health and will be expanded to include the medically

underserved and other health disparity groups as designated by the Agency for

Health Care Research and Quality. As a part of its mandate to build capacity for

minority health and health disparities research, the Center also will expand it’s support of training and the development of research infrastructure at Minority Serving

Institutions.

The complexity of the disparity in health status relates to convergence of multiple

factors in unsuspecting ways to cause differences in disease progression and in

health outcomes. If one tried to identify a priori all of the factors that could potentially impact the overall health of an individual, the results would look something

like the attached schema. Accordingly, the Center will promote and increase participation in minority health and health disparities research by expanding the number

of investigators involved in such research and by providing sustained funding for

a wide breadth of studies—basic, clinical, and population research; studies on the

influences of health processes; and research on the societal, cultural, and environmental dimensions of health—all aimed at identifying potential risk factors for disparate health outcomes.

LEVERAGING RESOURCES WITH THE NIH INSTITUTES AND CENTERS

The NCMHD will continue to provide funding support to assist the NIH Institutes

and Centers (ICs) in the following ways: piloting new health disparities programs,

improving recruitment and retention in clinical trials, and in providing competitive

supplements to expand the focus of existing programs. The Center also will share

in the support of selected targeted studies that are supported by the NIH ICs. Se-
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lected examples of the ways in which the Center leverages its funds with the NIH

ICs are provided below.

The Jackson Heart Study (JHS), a targeted study co-supported by the National

Heart, Lung, and Blood Institute and the NCMHD, is an investigation of the causes

of the high rate of cardiovascular disease in the State of Mississippi. The objectives

of the JHS are to: identify risk factors for the development and progression of CVD;

build research capacity in a minority serving institution; and expand minority participation in CVD epidemiology research. Initial examinations among the JHS cohort began in the fall of 2000 and will take 3 years to complete. Some of the newer

areas of focus will include early indicators of disease, genetics, sociocultural influences such as socioeconomic status and discrimination, and physiological relations

between common disorders such as high blood pressure, obesity, and diabetes and

their influence on CVD.

The Diabetes Genes, Treatment, and Prevention in Minorities Research program,

supported by the National Institute on Diabetes, Digestive, and Kidney diseases and

the NCMHD, focuses on the following groups: Hispanic diabetic adults residing in

a rural Texas-Mexico border community; centrally obese African-Americans with impaired glucose tolerance; obese Hispanic high school students in Colorado; African

American children, adolescents, and adults with diabetes; and Caribbean Latinos

with non-insulin dependent diabetes. Its objectives include the development of treatment and prevention interventions that specifically address diabetes in a range of

minority populations and elucidation of the genetic basis of diabetes in minority

populations and the underlying mechanisms controlled by gene expression.

The National Institute for Nursing Research (NINR) and the NCMHD will pilot

planning activities for a new partnership initiative in NINR’s extramural research

program. The focus will be on decreasing disparities in the burden of illness and

mortality experienced by racial and ethnic populations and the medically underserved through a variety of approaches, which include basic, epidemiological, clinical

and prevention, control and population research. Cultural and ethnic considerations,

genetic diversity, and social and economic influences on health and health outcomes

are potential areas of emphasis. The activity will include partnership research,

training, and other activities between Minority Serving Institutions and researchintensive majority institutions in institutions that provide services to the rural and

urban poor.

Other potential areas where the NCMHD will leverage its funds with the NIH

ICs include: the intersection of non-genetic factors and genes in health disparities,

infectious origins of chronic diseases and research training.

AN INDEPENDENT RESEARCH GRANT PORTFOLIO

Independent grant-making authority not only increases the Center’s flexibility in

leveraging its funds with the NIH ICs, but it also enables the Center to: focus on

‘‘gap areas’’ where such research is not conducted or supported by the NIH ICs;

more effectively build research capacity in minority health and health disparities research, address barriers to the participation of minority serving institutions in the

research enterprise, and to develop research capacity among community-based organizations.

With respect to research, the NCMHD recognizes several pressing priorities. Our

new Division of Research will develop programs to fund interdisciplinary teams of

biomedical, clinical, and social science investigators—teams that are crucial to developing strategies and tools for eliminating health disparities. Another priority of

the Division of Research is to ensure that the power of bioinformatics and genomics

research, including pharmacogenomics, is brought to bear on the health disparity

program.

Our new Division of Community-Based Research and Outreach will identify and

implement through research, effective and generalizable models of health care delivery, disease prevention and intervention, and communication that will improve community health outcomes in racial and ethnic minority and other health disparities

populations. The Division will utilize available data generated by other Federal and

State agencies to identify affected communities and to measure progress in outcomes associated with specific interventions. Key areas of focus will be to promote

research on investigation of health behaviors, cultural health beliefs and environmental factors in community health. Validated findings will be utilized and incorporated by the Division to develop culturally sensitive and appropriate communitybased prevention messages.
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CENTERS OF EXCELLENCE PROGRAM

As mandated in its statutory authorities, the NCMHD also will develop and implement a Centers of Excellence Program to support minority health research and

other health disparities research and research training for members of health disparity populations. The exploratory grant mechanism will be used to plan for and

promote interdisciplinary biomedical and behavioral research and to plan for the establishment of stable research and training programs. Center planning strategies

may focus on a specific research theme (e.g., diagnosis, therapy, epidemiology) or integrate a broad spectrum of research to include the basic, clinical, prevention, and

population sciences. Partnerships between minority institutions and majority institutions will be encouraged.

RESEARCH ENDOWMENT PROGRAM

The Center also will develop and implement a Centers of Excellence Endowments

Program for certain designated centers and those centers at Institutions of Emerging Excellence. Potentially a pilot initiative could begin in 2001. The purpose of the

program is to provide enduring, forward-looking, sustainable support for the Center’s minority health and health disparities research programs and to provide continuing research infrastructure support.

LOAN REPAYMENT PROGRAM

In fiscal year 2001, the NCMHD will develop and implement two distinct extramural loan repayment programs recently authorized by the Congress: the Clinical

Research Loan Repayment Program (LRP) and the Health Disparities Loan Repayment Program (HD–LRP). The emphasis of the LRP on ‘‘clinical research’’ and on

individuals from ‘‘disadvantaged’’ backgrounds is consistent with the objective of

building a culturally competent cadre of clinical investigators. Such a cadre of clinical investigators not only will have the potential of having an influence on the medical processes within their communities but can also engage in and promote the development of clinical research programs that reflect an understanding of the variety

of issues and problems associated with disparities in health status. The focus of the

health disparities LRP is specifically on clinical research related to diseases and

conditions having an increased prevalence among racial and ethnic minorities and

other designated health disparity groups.

OTHER CAPACITY BUILDING PROGRAMS

To expand the number of investigators participating in minority health and health

disparities research the NCMHD will promote, assist, and support research capacity

building activities in the minority and medically underserved communities. These

activities will focus on research infrastructure development, faculty career development, and increasing the number of under-represented minority students and students from health disparity groups with an interest in careers in biomedical and behavioral research.

HEALTH INFORMATION DISSEMINATION

Our health information dissemination activities will be multifaceted since professionals and the lay-public obtain information from very dissimilar sources. Information will be transmitted to professional medical and scientific organizations for dissemination among their membership, and also will be made available to the public

through media that are most likely to reach racial and ethnic minority groups.

CONCLUSION

Recognizing that the process of medical discovery occurs in stages, the Congress

has provided many new opportunities to build upon the previous efforts of the Office

of Research on Minority Health. Our commitment to the research needed to ultimately eliminate health disparities will be steadfast and enduring, and we will be

ever vigilant in our efforts. We are excited about these opportunities and greatly encouraged by the strong support the Center has received from the Congress, the Administration, our fellow NIH IC Directors and from groups and individuals across

the Nation.
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PREPARED STATEMENT OF STEPHEN E. STRAUS, M.D., DIRECTOR, NATIONAL CENTER

FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Center for Complementary and Alternative

Medicine for fiscal year 2002, a sum of $100,063,000, which reflects an increase of

$10,925,000 over the comparable fiscal year 2001 appropriation.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

The past year, NCCAM’s second, has been exciting and productive. With your generous support we continued to build a new research enterprise dedicated to defining

the effectiveness and safety of diverse complementary and alternative medical

(CAM) practices. Many Americans turn to these practices to relieve or prevent disease symptoms or the side effects of their treatment, despite a lack of clear and compelling data about them. We have the scientific tools, the commitment, and the resources to begin to guide their decisions regarding these practices. Consistent with

our mandate, we have identified priority areas that warrant more immediate action

due to pressing public health needs and either a dearth of valid scientific information or sufficient maturation of the science. Allow me to provide some examples of

our approach.

MECHANISMS OF CAM INTERVENTIONS

Among NCCAM’s highest priorities is the conduct of Phase III clinical trials of

CAM modalities. NCCAM’s Phase III clinical trials are built upon a substantial

body of scientific evidence concerning a given modality. While complex enough in design and ambitious enough in scope to address critical scientific issues and patient

safety concerns, these pivotal trials are also well poised to address the central question: ‘‘Does this therapy work?’’ In collaboration with other NIH Institutes and Centers (ICs), NCCAM supports the following multiyear, multicenter phase III clinical

trials: St. John’s wort for depression, with the National Institute of Mental Health

(NIMH); shark cartilage for lung cancer, the National Cancer Institute (NCI); Gingko biloba for dementia, the National Institute on Aging (NIA), the National Heart,

Lung and Blood Institute (NHLBI), and the National Institute of Neurological Disorders and Stroke (NINDS); acupuncture for osteoarthritis pain, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); and glucosamine/

chondroitin sulfate for osteoarthritis, NIAMS.

NCCAM also funds 15 specialty research centers, completing the research infrastructure platform on which to investigate the mechanisms underlying CAM treatments and their health effects. NCCAM-funded centers cover CAM approaches for

many areas of major public health need, including drug addictions, aging and women’s health, arthritis, craniofacial disorders, cardiovascular diseases, neurological

disorders, pediatrics, and chiropractic research. These centers constitute a major investment of NCCAM’s resources and serve as the focal point for initiating and maintaining state-of-the art multidisciplinary CAM research. They develop core research

resources, train new CAM investigators, provide community outreach and education,

and expand the research base through collaborative research and outreach to scientists and clinicians.

While CAM remedies have been employed for centuries, we still understand little

about them. By studying their underlying mechanisms, we could better monitor

their actions and develop biomarkers whose changes would correlate with beneficial

clinical outcomes. Thus, we would be better positioned to reveal which CAM modalities work and which do not, and inform the public accordingly.

One prospect is acupuncture, which, after millennia of empiric development and

widespread use in Asia, has emerged as an exciting but still poorly understood tool

for pain management. The ancients imagined pain as a result of imbalances in energy flow through defined body channels, or meridians. By inserting needles at precise points, practitioners attempted to correct the pain-provoking energies. In contemporary neurobiological terms we understand chronic pain as a result of abnormal

actions within key nerve-signaling pathways from the periphery to the central

brain. NCCAM grantees are testing the value of acupuncture for pain relief and

learning more about its mechanisms of action. Studies using remarkably sensitive

imaging techniques have pinpointed pain processing centers in the brain and

showed that the activity of these centers is altered when needles are inserted at the

body sites defined by the ancient Chinese practitioners as affording pain control.
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Acupuncture-mediated analgesia is not imagined, it is real. Our clinical trials are

exploring the range of conditions for which acupuncture may provide effective pain

relief. Our largest such study of acupuncture involves the pain of osteoarthritis.

In the largest and most rigorous trial of acupuncture to date, cosponsored by the

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the

short- and long-term safety and efficacy of acupuncture for the pain of osteoarthritis

of the knee are being evaluated. In this six-week study, 570 aging Americans are

being randomly assigned to: (1) true acupuncture; (2) sham acupuncture; or (3)

standard education and attention. The goal is to determine whether patients receiving true acupuncture experience significantly less pain and fewer limitation than

patients in the other groups. A separate follow-up of the patients in this study will

evaluate the long-term outcomes and cost-effectiveness of the acupuncture intervention.

Another key area of interest is the use of CAM to treat coronary artery disease

(CAD), which is the leading cause of mortality for both men and women in the U.S.

Despite increasingly effective conventional treatments for CAD, many turn to alternative approaches including the use of ethylenediaminetetraacetate (EDTA) chelation therapy, a popular but controversial approach. To date, however, studies of chelation therapy for CAD have been few, very small in size, and poorly designed, affording few conclusions concerning its true safety and effectiveness. To address this

important public health issue, NCCAM plans, in collaboration with the National

Heart, Lung and Blood Institute (NHLBI), to fund the first major, multi-site, clinical

trial to investigate the efficacy and safety of EDTA chelation therapy in individuals

suffering from CAD, using rigorous trial design and validated outcomes measures:

a solicitation (RFA) has been released.

CANCER

NCCAM is applying this same energy and commitment to studies of cancer. Our

rapidly growing research portfolio encompasses both the study of CAM cancer interventions and palliative care. In fiscal year 2000 NCCAM funded two new Specialty

Research Centers dedicated to studying the safety and effectiveness of several popular CAM cancer therapies. One center is evaluating the mechanisms of action, safety, and clinical efficacy of hyperbaric oxygen (oxygen at greater-than-atmospheric

pressures) treatment for head and neck cancers. The other center conducts studies

of breast cancer as well as the first randomized, placebo-controlled clinical trial of

a popular mixture of eight Chinese herbs, known as PC-SPES, in men with hormone-refractory prostate cancer. This latter study will evaluate PC-SPES for disease

progression, bone pain, and quality-of-life issues, such as changes in sexual function,

that so often accompany prostate cancers and their treatment. (The name PC-SPES

means hope for prostate cancer.)

Some menopausal and postmenopausal women find symptom relief through conventional estrogen replacement therapy (ERT). Research has also shown that ERT

benefits cardiovascular, skeletal, genitourinary, and cognitive health. Despite these

benefits, less than 20 percent of American women use ERT, in part because it seems

to be associated with an increased risk of breast cancer. This dissuades some women

from using it and excludes its use for breast cancer survivors. Many women explore

alternative approaches to estrogen replacement to eliminate the risks of conventional ERT, with the hope of reaping its benefits while avoiding its potential hazards. Soybeans are rich in naturally occurring compounds with estrogen-like activity. Several preliminary studies of popular soy-derived phytoestrogens (PEs) yielded

unclear and contradictory results, leaving open the question of whether soy may

protect against breast cancer or, like conventional ERT, promote its emergence.

NCCAM intends to conduct Phase II clinical trials to assess the impact of PE supplementation on women’s health after a breast cancer diagnosis.

Cancer patients for whom a cure is not an option face not only the prospect of

death, but also the diminution of quality of life and dignity, and intractable pain.

Perhaps as many as 70 percent of these cancer patients seek complementary and

alternative therapies to expand options for end-of-life care. NCCAM is soliciting

Phase I and II clinical trials of CAM modalities for: the prevention and management

of symptoms associated with the end of life, including secondary side effects of

chemotherapy and radiotherapy; and the enhancement of the patient’s well-being.

BOTANICALS

Botanicals, among the most popular CAM therapeutics, are relied upon for treatment and prevention of a number of conditions. In collaboration with the NIH Office

of Dietary Supplements (ODS), NCCAM funds four Centers for Dietary Supplement

Research with an emphasis on botanicals. The Centers identify and characterize
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botanicals, assess their bioavailability and activity, explore mechanisms of action,

conduct preclinical and clinical evaluations, establish training and career development, and help select the products to be tested in randomized controlled clinical

trials. Our plans include studying botanical-drug interactions, the developing standardized botanical products, and examining the safety and effectiveness of cranberry

products in preventing urinary tract infections.

HEALTH DISPARITIES

In conjunction with the trans-NIH effort to address U.S. health disparities, we

have recruited a director for the NCCAM Office of Special Populations and charged

him to expand our own research plan in this area. We plan to: identify the extent

and nature of CAM use among special populations; studying the application of CAM

therapies to reduce disparities; increase participation of underrepresented populations in NCCAM-supported clinical trials; and enhance the ability of minority institutions to support CAM research. This plan will serve through fiscal year 2005

as a guide for developing new initiatives to address minority health and health disparities. In the near term, NCCAM intends to determine the prevalence of CAM use

by different minority and underserved populations, initiate studies on the use of

magnesium sulfate in the treatment of acute asthma, and use the National Research Training Award (T32) mechanism to support pre- and post-doctoral trainees

in CAM research at minority and minority-serving institutions.

INTEGRATIVE MEDICINE AND RESEARCH TRAINING

NCCAM has initiated a series of specific activities to facilitate the successful integration of safe and effective CAM modalities into mainstream medical practice. We

conduct research that provides compelling evidence of efficacy and safety and publishing these findings in peer-reviewed journals, study factors that promote or impede integration, support the development of model curricula for medical and allied

health schools and continuing medical education programs, and inform the public

in a clear and definitive manner. In fiscal year 2001, we launched a new integration

initiative to study factors that promote or impede integration, determine whether

CAM research results can be translated to real-world settings, and support the evaluation of programs that integrate CAM and conventional care. Integrative medicine

is also a key component of NCCAM’s Intramural Research Program and a component of NCCAM’s Specialized Research Centers.

NCCAM’s ability to achieve its research goals depends on the availability of a critical mass of skilled investigators in both CAM and conventional communities. It is

our goal to increase the knowledge, experience, and capacity of CAM practitioners

to conduct or participate in rigorous research. We also intend to enhance conventional practitioners’ and researchers’ knowledge and experience in specific CAM

areas. We actively support research training by making awards to both institutions

and individuals. Likewise, NCCAM supports mentored and independent trainees,

from the pre-doctoral level through mid-career and senior faculty members. The research spectrum of these trainees is broad, covering the continuum of basic through

clinical studies. NCCAM supports all of the major training mechanisms offered by

NIH.

CONCLUSION

As the graying of America progresses, more of our citizens are choosing CAM approaches when conventional medicine fails to provide complete satisfaction. It is,

therefore, imperative that we continue to expand our research portfolio, train researchers, and fund research studies to scientifically establish critical safety and efficacy information for dissemination to healthcare providers and consumers. I am

confident that the results of our rigorous research will further enhance the successful integration of safe and effective CAM modalities into mainstream medical practice.

I am now happy to take your questions about these or any other of NCCAM’s activities and plans.

PREPARED STATEMENT OF ALLEN M. SPIEGEL

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for fiscal year 2002, a sum of $1,457,915,000, which reflects

an increase of $154,098,000 over the comparable fiscal year 2001 appropriation. The

NIH budget request includes the performance information required by the Govern-
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ment Performance and Results Act (GPRA) of 1993. Prominent in the performance

data is NIH’s second annual performance report which compares our fiscal year

2000 results to the goals in our fiscal year 2000 performance plan. As performance

trends on research outcomes emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.

The NIDDK supports research on a wide range of chronic, debilitating diseases

including diabetes; hepatitis and other liver diseases; inflammatory bowel disease;

interstitial cystitis and other bladder conditions; prostatitis and benign prostate enlargement; several anemias; and polycystic kidney disease and other causes of endstage kidney failure. The economic burden of these diseases accounts for a major

portion of U.S. health care expenditures. Advances in biomedical research are critical if we are to mitigate the human and economic burden of these diseases. With

the generous support Congress has provided, NIDDK-supported scientists are well

positioned to identify the causes of the diseases within our mission, to help identify

people at risk for development of these diseases, and, ultimately, to provide novel

approaches to prevention and treatment.

DIABETES

One of the most important health care issues facing our Nation is the increasing

burden of diabetes. According to the Centers for Disease Control and Prevention

(CDC), diabetes affects an estimated 16 million Americans, one-third of whom are

unaware they have the disease and are therefore untreated. An estimated 30 million

additional Americans have a pre-diabetic condition known as impaired glucose tolerance. Within the last year, scientists have made tremendous progress in understanding and treating both type 1 and type 2 diabetes. Type 1, or juvenile diabetes,

occurs when the body’s immune system destroys the insulin-producing beta cells in

the islets of the pancreas. Type 2 diabetes, previously called non-insulin dependent

or adult-onset diabetes, results from the body’s inability to respond to insulin effectively—a condition known as insulin resistance—followed by a failure of the beta

cells to produce sufficient insulin.

People with type 1 diabetes must take regular insulin injections to survive. However, insulin represents only a treatment for type 1 diabetes, not a cure. Recent advances have created new hope for a cure for type 1 diabetes through pancreatic islet

transplantation. The NIDDK is supporting several clinical trials to expand upon a

promising study in which islet transplantation permitted a small number of people

with type 1 diabetes to remain healthy for over a year without daily insulin injections. We are also supporting research on many aspects of beta cell development

and function so that we can address the problem of the inadequate supplies of donor

pancreatic tissue for transplantation, possibly by developing alternative sources of

islet beta cells. In addition, we are supporting research on alternatives to lifelong

immunosuppressive drug treatment currently required to prevent rejection of transplanted islets. One innovative approach uses a short course of therapy to teach the

immune system to accept a transplant as ‘‘self,’’ avoiding tissue rejection without

global immunosuppression. Not only do these novel approaches to educating the immune system increase the likelihood of achieving a true cure for type 1 diabetes,

they also offer hope of preventing the disease in those at risk. Trials of innovative

prevention measures will be performed as part of our newly-created type 1 diabetes

TrialNet.

Type 2 diabetes is a ‘‘complex genetic disease’’ with subtle changes in the function

of several genes contributing to disease susceptibility. Despite the technical difficulties in identifying such gene changes, researchers studying a population of Mexican

Americans who are particularly prone to type 2 diabetes identified changes in a

gene—NIDDM1—that correlate with development of the disease. The product of this

gene—calpain 10—is present in pancreatic islets, muscle, and liver—all tissues that

are involved in insulin and glucose processing. Scientists have identified at least

three other chromosomal regions whose products may interact with NIDDM1 to increase susceptibility to type 2 diabetes. Knowledge of the genetic basis for diabetes

susceptibility paves the way to improved prevention and diagnosis by identifying individuals at risk, and to improved treatment by providing new targets for therapy.

Obesity is a major risk factor for type 2 diabetes. The alarming increase in the

number of people who are overweight or obese in the U.S. population has led to a

coincident increase in type 2 diabetes in adults, and even in children and adolescents. Successful control of body weight could therefore profoundly diminish the incidence of type 2 diabetes. In just the past few years, there have been major advances

in our understanding of how weight is regulated. Scientists have identified many

of the steps in a complex pathway that controls both appetite and metabolic rate.

An imbalance in this regulation can lead to the accumulation of excessive body fat.
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Until recently, the precise mechanism by which excess fat led to insulin resistance

and type 2 diabetes was unclear. However, several recent advances have changed

the way scientists view fat, and have underscored that fat—far from being an idle

repository of excess energy—is in fact a dynamic tissue that produces a number of

hormones with the potential to influence appetite and metabolism.

Leptin, a protein produced by fat cells that acts on the brain to suppress appetite,

was discovered just six years ago, but has already entered clinical trials in humans.

More recently, by ‘‘mining’’ mouse and human genome sequences, scientists have

identified other hormones produced by fat cells that act on muscle and liver—the

primary sites in the body of glucose metabolism and insulin action. For example,

NIDDK grantees identified a protein produced by fat cells they termed ‘‘resistin,’’

because it promotes insulin resistance. Obesity causes increased levels of resistin in

blood, thus providing a direct link between excess body weight and the diminished

insulin sensitivity often seen in overweight individuals. Another group of NIDDKsupported investigators identified another protein produced by fat cells—called

Acrp30—that acts to increase fat metabolism in muscle, thereby promoting weight

loss. Together, these studies indicate that fat cells produce hormones that may either promote or inhibit insulin responsiveness. Under normal circumstances, these

two opposing signals keep each other in check. However, in obese individuals, this

balance may be perturbed, and drugs that block or mimic these hormones may

prove useful in both prevention and treatment of obesity and type 2 diabetes.

In addition to genetic susceptibility, the environment exerts an influence on the

development of obesity and type 2 diabetes. The NIDDK is therefore supporting initiatives on environmental approaches to obesity prevention, including educational

efforts. We are launching a major initiative aimed at prevention and treatment of

type 2 diabetes in children and adolescents. A major multi-center clinical trial, the

Diabetes Prevention Program (DPP), is testing the ability of lifestyle and drug intervention strategies to prevent type 2 diabetes in individuals with impaired glucose

tolerance who are at high risk for the disease. The results of this trial, slated for

completion in 2002, may have major public health implications for the prevention

of type 2 diabetes.

Diabetes is the leading cause of end-stage kidney failure, new cases of blindness

in adults, and non-traumatic lower limb amputations. It also causes increased susceptibility to urinary tract infections and a progressive form of fatty liver disease

known as non-alcoholic steatohepatitis (NASH). Heart disease is the leading cause

of death in diabetics, and the NIDDK is sponsoring a clinical trial—Look AHEAD—

that will determine whether sustained weight loss in obese people with type 2 diabetes can reduce the incidence of cardiovascular complications. According to the American Diabetes Association, diabetes cost the country $98 billion in 1997, and over

half of this expense was related to the disability, lost productivity, and early mortality associated with the disease. We know that prevention of diabetes, and where

prevention is not possible, optimal management of the disease, not only alleviates

human suffering but is cost-effective. For this reason, the NIDDK is exploring many

avenues of prevention and treatment for diabetes and its complications, including

basic genetic and molecular studies, development of animal models to facilitate testing of new drugs, therapeutic gene transfer techniques, and drug intervention trials.

We are also increasing the resources available to our Diabetes Research and Training Centers to enhance efforts in diabetes prevention and treatment, and are expanding the National Diabetes Education Program (NDEP), which supports community-based multi-cultural efforts to increase diabetes awareness, to improve care of

people with diabetes.

HEPATITIS C AND OTHER CHRONIC LIVER DISEASES

The NIDDK supports research on many other serious diseases, including liver disease arising from a range of causes. In the U.S., infection with the hepatitis C virus

is a leading cause of liver failure and can lead to liver cancer. The newly-initiated

HALT–C trial is testing whether long-term antiviral treatment can eliminate the

hepatitis C virus in patients who fail to respond to conventional treatment. We are

also initiating a trial of interferon treatment for hepatitis C in African Americans,

whose disease is often resistant to the standard treatment regimen.

The NIDDK is also studying NASH, a disease characterized by fat deposition in

the liver that can lead to inflammation, fibrosis, and cirrhosis. NASH is most often

seen in overweight individuals and is associated with diabetes and insulin resistance. NIDDK plans a clinical research network to study the natural history, complications, and possible therapies for NASH. Whatever the precipitating cause, liver

failure is ultimately only treatable currently through liver transplantation. Unfortunately, the need for donor livers far outstrips the supply of available organs. The
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NIDDK organized a workshop in December 2000 to assess recent advances in adultto-adult living donor liver transplantation. An important outcome of this meeting is

the development of a research initiative for a prospective database to further knowledge about the consequences of living donor liver transplantation, both for the donor

and the recipient.

INFLAMMATORY BOWEL DISEASE AND OTHER DIGESTIVE DISEASES

The NIDDK sponsors studies on the inflammatory bowel diseases (IBDs), ulcerative colitis and Crohn’s disease, including efforts to identify their genetic and environmental causes. A contributing factor to both conditions is believed to be an inappropriate reaction by the body’s immune system to the bacterial flora normally

present in the gut. Previous research on mouse models of IBD led to the discovery

of a factor responsible for gut inflammation, and ultimately to development of an

antibody to neutralize this factor that has been shown to be effective in treatment

of Crohn’s disease. In recent studies, NIDDK-supported investigators have identified

a strain of mice that spontaneously develop intestinal inflammation remarkably

similar to Crohn’s disease. They have shown that these mice can be efficiently used

to test new treatments for the disease. In the future, the NIDDK plans an IBD Genetics Consortium to facilitate identification of susceptibility genes, and a clinical

network to accelerate studies of prevention and treatment of IBD.

END–STAGE RENAL DISEASE AND POLYCYSTIC KIDNEY DISEASE

According to the United States Renal Data System, individuals with diabetes account for approximately 45 percent of patients with end-stage kidney disease. Because of this, the NIDDK is concentrating its efforts on preventing diabetic kidney

disease and slowing its progression. The Institute is expanding the FIND (Family

Investigation of Nephropathy and Diabetes) consortium to identify genetic loci and,

ultimately, the specific genes that influence susceptibility to, and severity of, diabetic nephropathy. The Institute is also investigating the causes and possible new

treatments for FSGS (Focal Segmental Glomerular Sclerosis), an important cause of

kidney failure in children and young adults. The Institute plans a multi-center clinical trial to study treatment approaches for FSGS.

NIDDK support is also making a difference in understanding other important

causes of irreversible kidney failure such as polycystic kidney disease (PKD).

NIDDK-funded researchers are studying non-invasive means of assessing PKD progression, which will facilitate a planned clinical trial of drug intervention to slow

progression. A new prospective observational study is aimed at understanding the

factors responsible for the high incidence of heart disease in patients with end-stage

kidney disease. Because folate lowers levels of homocysteine, a known risk factor for

heart disease, we are also planning a clinical trial on the use of high doses of this

vitamin in the prevention of heart disease in renal transplant recipients. We are

also launching a National Kidney Disease Education Program to address the rising

incidence of end-stage kidney disease, particularly in various minority groups.

UROLOGIC DISEASES

The NIDDK is sponsoring initiatives to promote understanding of a range of urologic diseases, including interstitial cystitis, benign prostatic hyperplasia (BPH), and

chronic prostatitis. The Institute is working to organize a compendium of ‘‘Urologic

Diseases in America’’ that will describe the changes in the epidemiology, health economic impact, and practice patterns for each of the diseases currently included within the scope of urology. The Institute has recently organized a Progress Review

Group for Bladder Research to develop a future research agenda. We are also building on our Medical Therapy of Prostatic Symptoms (MTOPS) Trial with a national

registry of prostate tissue samples that will allow urology investigators to harness

genomic technology to study BPH and prostate cancer.

The NIDDK continues to pursue many approaches to combat the serious diseases

within its mission in order to relieve the burden they place on individuals, families,

and the Nation. I appreciate the opportunity to address the Committee, and I thank

you for your attention. I look forward to answering any questions you might have.

PREPARED STATEMENT OF LAWRENCE A. TABAK, DIRECTOR, NATIONAL INSTITUTE OF

DENTAL AND CRANIOFACIAL RESEARCH

I am pleased to present the President’s budget request for the National Institute

of Dental and Craniofacial Research (NIDCR) for fiscal year 2002, a sum of
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1 Brown, L.J., T. Beazoglou and D. Heffley. ‘‘Estimated Savings in U.S. Dental Expenditures,

1979–1989’’. Public Health Reports, 1994, 109, 195–203. 2Miller, B.A. et al, editors. Racial/Ethnic Patterns of Cancer in the United States, 1988–1992.

National Cancer Institute, National Institutes of Health. NIH pub. No. 96–4104. Bethesda (MD):

National Institutes of Health, 1996. 3 National Center for Health Statistics 9NCHS). Third National Health and Nutrition Examination Survey (NHANES III) reference manuals and reports. Hyattsville, MD: NCHS, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control

and Prevention, 1996. 4 Albandar JM, Brown LJ, Loe H. Clinical features of early-onset periodontitis. Journal of the

American Dental Association 1997 Oct;128(10): 1303–9.

$341,898,000, which reflects an increase of $35,687,000 over the comparable fiscal

year 2001 appropriation.

The first-ever Surgeon General’s report on oral health was released last year, and

the good news was that Americans as a whole have benefitted greatly from advances in disease prevention and health promotion in recent decades. Improvements

in oral health because of research have saved the nation an estimated $5 billion a

year in dental bills-an annual savings amounting to more than the cumulative funding for NIDCR since its inception in 1948.1 Our work is not finished, however. Millions of Americans still experience pain and suffering from complex diseases affecting the mouth and face, including oral cancer, cleft lip and palate, dental caries

(tooth decay), periodontal (gum) diseases, and temporomandibular disorders. More

research is needed to understand the associations between oral infections and conditions such as diabetes and low birth weight. We also need new studies to help us

understand and eliminate oral health disparities in this country. By funding cutting

edge biomedical and behavioral research, NIDCR strives to fulfill our mission of improving oral health for all Americans.

REDUCING ORAL HEALTH DISPARITIES TO IMPROVE QUALITY OF LIFE FOR ALL

AMERICANS

Scientific advances have led to substantial gains in the nation’s oral health, but

not all Americans have shared equally in these gains. Disparities in oral health

exist at all ages and in many different population groups within our society. For

example:

—Cancers of the mouth and throat, which kill about 8,000 Americans a year, take

a disproportionate toll on African Americans, particularly men. African American men are one-third more likely than whites to be diagnosed with oral cancer, and their 5-year survival rate is only 28 percent, compared to a 53 percent

survival rate for white men.2

—Dental caries, or tooth decay, is the most common chronic disease of childhood—

five times more common than asthma and seven times more common than hay

fever. Children from low-income families suffer twice as much dental decay as

their better-off peers, and their disease is more likely to go untreated.3

—African American adolescents are 10 times more likely than white teens to suffer from early-onset periodontitis, a severe and rapidly progressive form of gum

disease that destroys the bone supporting the teeth.4

The causes of these and other oral health disparities are not fully understood, but

genetic, environmental, and behavioral factors all likely play a role. This year,

NIDCR will establish Centers for Research To Reduce Oral Health Disparities. The

centers will conduct a broad range of interdisciplinary research aimed at reducing

health disparities. Much of this work will be focused on, and conducted in, the communities where the disproportionate disease burden is evident. The centers will provide ideal environments for training new scientists, particularly those from minority

groups underrepresented in the scientific workforce. Because cross cutting research

is essential for reducing health disparities, we are using mechanisms designed to

encourage training in multidisciplinary research. Recognizing the need to establish

the effectiveness of interventions for different population groups, we are also taking

steps to ensure that all population groups are appropriately represented in clinical

trials. These steps include providing investigators with the tools to facilitate community-based linkages for research. One advance with potential for application in community settings is the use of saliva-based diagnostic tests. Saliva, which is easier

and less invasive to collect than blood, is already being used in a number of tests,

and may provide a means of detecting diseases such as oral cancer at an earlier,

more curable stage.
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5Langer, R. and Vacanti, J.P. ‘‘Tissue Engineering’’, Science, May 14, 1993, 260. 92.

CHRONIC INFECTIOUS DISEASES: DENTAL CARIES AND PERIODONTAL DISEASES

The most common oral diseases, and among the most prevalent of all chronic infectious diseases, are dental caries (tooth decay) and periodontal (gum) diseases.

These diseases affect people throughout the life span, requiring lifelong attention by

both the individual and health care providers. The Health Care Financing Administration estimates that dental expenditures by 2000 approached $60 billion, most of

which was spent repairing teeth and periodontal tissues.

Dental caries and periodontal diseases are infections caused by bacteria that accumulate in the form of a ‘‘biofilm’’ on the surfaces of teeth and soft tissues. NIH and

NIDCR recently sponsored a Consensus Development Conference on the diagnosis

and management of dental caries that pointed to the need for earlier detection of

dental decay to allow for more conservative intervention.

Long considered localized infections, periodontal diseases are now linked to a

number of systemic diseases and conditions. For example, periodontal disease in

pregnant women may contribute to the risk of delivering pre-term, low birth weight

babies. The destructive inflammatory processes that define periodontal disease are

also intertwined with diabetes. Periodontal diseases are exacerbated in individuals

with uncontrolled diabetes, and researchers are examining the effects of periodontal

infections on blood sugar control. These and other interrelationships were highlighted at a recent symposium co-sponsored by the NIDCR entitled ‘‘The Periodontal-Systemic Diseases Connection.’’

RESEARCH CREATES NEW MATERIALS FOR REPLACING AND RESTORING DAMAGED

TISSUES

As people continue to live longer, the demand increases for ‘‘new parts’’ to repair

or replace those lost to disease, injury, and wear-and-tear. Each year, millions of

Americans suffer some type of tissue loss or end-stage organ failure, at a cost of

more than $400 billion annually.5 Included in these figures are millions of dental,

oral, and craniofacial procedures, ranging from tooth restorations to major reconstruction of facial tissues.

Biomimetics (literally, to mimic biology) and tissue engineering are new disciplines that have emerged to meet the challenge of rebuilding the body. In the

same way that Velcro inventor George de Mestral imitated the natural adhesion of

burrs, biomimetics researchers take cues from nature to design ‘‘bio-inspired’’ materials. For example, NIDCR-supported scientists have created a biomimetic material

that promotes bonding of bone-forming cells to artificial surfaces, an achievement

with tremendous potential for improving dental and orthopedic implants. Poor bonding to surrounding bone is one of the biggest reasons for dental implant failure. The

researchers synthesized a material that mimics a natural binding site for bone-forming cells; when an artificial surface is coated with the material, bone-forming cells

respond by building new bone around the surface, creating a strong bond.

Using the new technology of tissue engineering, NIDCR researchers are developing an artificial salivary gland that could restore salivary flow to patients whose

own glands are destroyed by disease or radiation therapy for head and neck cancers.

Currently no effective treatments exist for these patients, whose quality of life is

severely compromised by difficulties in chewing, swallowing, and speaking and by

an increased risk of rampant tooth decay and other oral infections. The NIDCR scientists are creating a small tube that could be implanted in a patient’s cheek. The

tube will be lined with cells engineered to secrete a saliva-like fluid. The artificial

salivary gland could be ready for clinical testing within 5 to 7 years.

GENETIC RESEARCH IS KEY TO UNDERSTANDING CRANIOFACIAL DISORDERS

Genetic research by NIDCR scientists is revealing the basis for a number of

craniofacial birth defects, offering hope to thousands of Americans who suffer pain,

dysfunction, and emotional consequences from malformations of the mouth and face.

Cleft lip, with or without cleft palate, is among the most common of human birth

defects, affecting 1 in 1,000–2,500 newborns. Most cleft disorders-in which the lip

or palate fail to fuse properly-occur alone, although they may also be part of birth

defect syndromes that affect many organs and tissues. Many cleft disorders are

caused by single gene mutations. NIDCR-supported scientists recently identified a

gene called PVRL1 as the cause of one form of cleft lip/palate. The gene codes for

a cell surface adhesion protein called nectin–1. In mice, this protein aids in the development of the palate, teeth, and skin—the same tissues that are malformed in

humans with a mutation in PVRL1. Other NIDCR-funded researchers have found
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that a mutation in a gene called PAX9 results in missing molar teeth. Their work

may lead to a better understanding of congenital disorders in which teeth fail to develop. Approximately 20 percent of the population is born unable to develop a full

set of permanent teeth.

INVESTIGATING THE ORAL CAVITY’S CONTRIBUTION TO DEFENDING THE BODY AGAINST

HIV INFECTION

The specific factors that result in relatively high rates of HIV–1 transmission by

breast milk but minimal rates of transmission by saliva are not known. Therefore,

studies of oral defense systems may prove instructive for development of new preventive strategies for HIV infection. One intriguing finding is that saliva consistently exhibits anti-retroviral activity, whereas breast milk only displays this property when collected during the first three weeks after childbirth. The potentially important anti-retroviral activity appears to be lost three weeks postpartum. While

many factors likely contribute to the anti-retroviral activities observed in saliva and

breast milk, one factor, called secretory leukocyte protease inhibitor (SLPI), is found

at high levels in saliva. While SLPI levels are high in breast milk at birth, this antimicrobial substance virtually disappears from the milk three weeks after delivery.

Despite the risk of HIV–1 transmission from breast-feeding, the risk of death from

malnutrition for nonbreast-fed children in many parts of the world has resulted in

controversial recommendations about breast-feeding. Studies on the timing of postnatal transmission of HIV–1 and the innate protective correlates may provide a better understanding of a ‘‘safer’’ window of breast-feeding and the specific roles of

anti-retroviral substances in natural secretions that could be exploited as future

therapies.

NEW METHODS NEEDED TO TREAT CHRONIC PAIN AND TEMPOROMANDIBULAR

DISORDERS

Most people have experienced some form of oral-facial pain. A variety of painful

facial conditions may interfere with vital functions such as eating or speaking.

NIDCR scientists are continuing to develop novel approaches to selectively block

pain receptors in the body. A recent study in an animal model makes use of gene

therapy to deliver a message to cells that ‘‘tricks’’ them into producing reduced levels of pain receptors on their surfaces. If similar techniques can be designed to work

in humans, this approach may benefit chronic pain patients.

Various factors, including trauma, can give rise to pain and dysfunction in the

temporomandibular joints and surrounding muscles—conditions collectively called

TMD. The multiplicity of factors that may cause or contribute to TMD has unfortunately led to an even greater number of treatments that have not been validated.

NIDCR is conducting clinical trials looking at the effects of conservative versus surgical interventions, with preliminary findings indicating that surgical interventions

offer no increased benefits. To address the needs of patients who require joint replacement, NIDCR is conducting basic research on engineering more biocompatible

implants. Given the complexity of TMD and the need to approach this condition in

a multidisciplinary manner, the Institute established the TMD Interagency Working

Group to facilitate progress in dealing with these disorders through cooperation,

communication, and collaboration among the many Federal agencies that conduct or

support TMD-related research and direct provision of health care services.

GOVERNMENT PERFORMANCE AND RESULTS ACT

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) Of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

I became Director of NIDCR eight months ago with great enthusiasm about the

opportunities to make a difference in improving the nation’s oral health through biomedical research. As NIDCR Director, one of my main goals is to accelerate our

progress toward relieving the burden of the many chronic and costly diseases that

affect the mouth and face. Having been an NIDCR grantee for many years, I knew

before arriving how important the Institute is to the scientists who conduct oral,

dental, and craniofacial research and to the well being of the people of this country.

Seeing it work from the inside has given me a new appreciation for the organization, its talented and dedicated staff, and the role of the Institute nationally and

internationally.
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Thank you for the opportunity to provide you with information on NIDCR’s research efforts.

PREPARED STATEMENT OF DR. JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER

FOR RESEARCH RESOURCES

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the National Center for Research Resources (NCRR) for

fiscal year 2002, a sum of $974,038,000, which reflects an increase of $156,785,000

over the fiscal year 2001 appropriation.

It is a pleasure once again to have the opportunity to present the accomplishments of NCRR-supported research and future directions for NCRR programs. With

the human genome and several others essentially sequenced, biomedical research is

entering a new age. Up until now, biomedical science has benefitted greatly from

a reductionist perspective which examines single genes or their encoded

macromolecules to determine the cause of disease. But today, new research technologies enable scientists to pry ever deeper into the cell to uncover the structural

and functional secrets of the ribosome which serves as the cell’s protein factory and

also to find hundreds of disease-associated proteins. With advanced technologies investigators have discovered defective membrane potassium channels responsible for

some forms of epilepsy or abnormal heart rhythms that may be fatal if the genetic

abnormalities resulting in altered potassium channel function are not detected and

treated.

Sophisticated biomedical research now frequently requires a multidisciplinary approach with teams that include physician-investigators, physicists, bioinformaticists,

physical chemists, structural biologists, and others. The research team must not

only take full advantage of existing novel research tools but must also develop novel

ones to solve new complex research problems.

To facilitate this new paradigm for research, NCRR’s programs need to modify or

generate new, more sophisticated resources to enable research in the 21st century.

NCRR provides the critical research infrastructure that enables all lines of biomedical inquiry, from the molecular level to the whole organism. Specially adapted

clinical research facilities assure that the fruits of bench research reach the patient.

The network of NCRR’s General Clinical Research Centers (GCRCs) require sophisticated core laboratories and bioinformatics tools to facilitate research. To foster

multisite research collaborations, NCRR supports development of web-based research networks for clinical trials and research on the molecular and other causes

of disease.

To enhance access to costly technologies, NCRR works in partnership with other

Federal agencies, such as the Department of Energy and the National Science Foundation (NSF). For decades, NCRR has funded a substantial research effort to improve x-ray crystallography techniques. NCRR has been a pivotal player in developing very high intensity x-ray sources for biological research at the national synchrotron facilities, through cooperative approaches with DOE and NSF staff. The

nation’s synchrotron facilities are critical for ascertaining the structures of biological

molecules encoded by thousands of genes. With the incorporation of robotics, newer

imaging technologies along with methods to automate data collection and processing, an appropriately equipped research resource may conduct more than one

hundred thousand crystallization experiments per day! Using NCRR research resources, studies in the past required years of effort, will be accomplished in a week!

NCRR also supports programs to enhance the research capabilities of minorityserving graduate institutions through the Research Centers in Minority Institutions

(RCMI) program. Separately, through the Institutional Development Award (IDeA)

program, NCRR provides funding for capacity building for biomedical research in

those States which have not previously participated fully in the research programs

of the NIH. The current cohort of 23 IDeA-eligible States and Puerto Rico receives

about five percent of NIH grant funds annually.

GENOMICS AND GENETIC MEDICINE

To determine the genetic causes of diseases, large numbers of patients must be

screened for specific gene variants. NCRR proposes to support national genotyping

laboratories to provide a cost-effective, high throughput approach. Genotyping attempts to find nucleotide substitutions at specific points, or loci, within a gene that

may be defective and cause disease. In addition, NCRR proposes to expand the capacities of its mouse mutant regional resource centers network to accommodate a

rapidly expanding pool of mouse mutants and to support a web-based catalog of

their genetic variants and physical characteristics or phenotype. The mutant mouse
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network’s catalog will facilitate investigator access to mouse mutants needed for

their research.

Scientists today urgently need improved or new technologies to study the thousands of proteins that interact with one another to make a cell function as a tightly

controlled unit. This complex research requires an integrated or systems approach.

In response, NCRR proposes to develop and support comprehensive Integrated Biomedical Technology Resource Centers, where multiple complementary technologies

examine the inner workings of both healthy and diseased cells. Research areas that

can be facilitated through integrative approaches include those for proteomics, imaging, structural biology and glycobiology.

NCRR proposes to develop the rhesus macaque as an nonhuman primate model

of genetic disease in humans. In collaboration with the National Human Genome

Research Institute, NCRR will provide support for the development of BAC (Bacterial Artificial Chromosome) libraries as well as for genetic and radiation hybrid

maps. New technologies have made it theoretically possible to selectively modify

genes of nonhuman primates to create defects that mimic human diseases, such as

cystic fibrosis. Studies will also address how risk factors modulate gene function in

polygenic disorders such as type 2 diabetes mellitus and hypertension.

BIOENGINEERING, BIOIMAGING, AND BIOINFORMATICS

Today’s biomedical research depends on sophisticated research technologies more

so than in the past. NCRR proposes to increase support for instruments in the

$100,000 to $500,000 range through its Shared Instrumentation Grant (SIG) Program. The off-the-shelf instruments in greatest demand through the SIG program

include confocal microscopes, NMR spectrometers, cell sorters, mass spectrometers

and protein/DNA sequencers. To address the broad research community needs of the

instrumentation that costs between $500,000 and several million dollars, NCRR proposes to initiate a new program to provide advanced instrumentation that includes

very-high-field NMR spectrometers, synchrotron facilities, mass spectrometers,

cryoelectron microscopes, and high-performance supercomputers.

To further enhance the national infrastructure for biomedical research, NCRR will

establish a biomedical imaging research network (BIRN) test bed for development

of hardware, software, and protocols to effectively share and mine data in a siteindependent manner for both basic and clinical research. For this undertaking,

NCRR has teamed up with the San Diego Supercomputer Center, one of three National Science Foundation-supported centers for advanced computational infrastructure, to provide biomedical investigators access to sophisticated modeling and computational tools. Other partners include the NSF, University of California at San

Diego and several NIH Institutes along with seven institutions with NCRR-supported general clinical research centers, co-located with imaging technology centers.

The BIRN will include image data with high-bandwidth requirements, as well as

genomic, structural, and gene expression data. The BIRN will be designed so that

it can be readily expanded to meet the evolving needs of basic and clinical investigators across a network of resource centers that provide access to specialized research

facilities, repositories and regional core facilities to enable research nationwide.

NEW PREVENTIVE STRATEGIES AGAINST DISEASE

Not all research advances lie in medical genetics. Scientists have observed recently that transplantation of insulin-producing human pancreas cells, called islet

cells, to patients with type I diabetes can free them from the need for insulin injections. But to get a sufficient supply of these scarce and difficult-to-isolate cells, cellharvesting efficiency and islet cell stability need to be optimized. To pursue these

very promising results, which eventually may provide a cure for type I diabetes,

NCRR—together with the National Institute of Diabetes and Digestive and Kidney

Diseases and the Juvenile Diabetes Research Foundation International-will establish several Islet Cell Resource Centers to optimize the isolation, purification, and

function of islet cells for transplantation into patients with type I diabetes.

As clinical research becomes more complex and promising new therapies are evaluated, more attention to the safety of research subjects must be taken. The NCRR

will provide support for a Research Subject Ombudsman (RSO) at each General

Clinical Research Center (GCRC) and RCMI Clinical Research Center to ensure that

the research subject monitoring plan at these resources is fully implemented and

carried out according to the Institutional Review Board-approved protocol. The Ombudsman will also ensure that investigators report serious adverse events within a

required time frame to appropriate agencies, offices or Boards. Th RSO will also

keep patients and volunteers informed about the research projects and clinical trials

in which they participate.
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HEALTH DISPARITIES

To address the health concerns of minority populations, NCRR proposes to establish Comprehensive Centers for Health Disparities Research at minority-serving

medical schools associated with the NCRR-funded Research Centers in Minorities

Institutions. These Centers will further develop their medical schools’ capacities to

conduct basic and clinical research on type II diabetes and cardiovascular disease,

which disproportionately affect minority populations. The Centers will support further development of the host institution’s research infrastructure, including laboratories, faculty recruitment of established clinical investigators and development of

promising junior faculty. Collaboration with nearby research-intensive universities

will be strongly encouraged. To further strengthen these minority institutions,

NCRR also proposes to establish a Web-based clinical trials network for minorityserving institutions. This new network will better position minority-serving medical

schools to more fully participate in NIH-supported research, including multi-site

clinical trials that address diseases that disproportionately affect minorities and underserved populations.

RESEARCH TRAINING AND CAREER DEVELOPMENT

Proper training in research methodology is essential for young scientists. NCRR

proposes to initiate new mentored programs for medical and veterinary students to

develop their research skills and pique their interests in research careers to enhance

the pool of well-trained young physicians and veterinarians who will become the

independent investigators for tomorrow’s health-related research.

In addition to expanding support for the Mentored Patient-Oriented Research Career Development Award (K23), NCRR proposes to initiate a new career development program for physicians and dentists through a mentored institutional Clinical

Research Scholars (CRS) program. That CRS pilot program will be phased in over

several years at approximately ten institutions. The flexible program will provide

tuition support for didactic courses, leading to an M.S., Ph.D. or M.P.H. degree. The

CRS program support for candidate development of clinical and bench patient-oriented research skills in a mentored setting is central to this new program. The long

term CRS program goal is to enhance the pool of high quality independent clinical

investigators.

RESEARCH CAPACITY

Adequate, up-to-date facilities are indispensable for biomedical research, but according to a 1998 NSF survey, biomedical research institutions had to defer $5.6 billion for needed construction and renovation projects. The greater biocomplexity of

modern research requires state-of-the-art research facilities. The NSF survey estimated that less than half of existing research facilities could conduct sophisticated

biomedical research. Through the NIH Research Facilities Improvement Program,

NCRR will expand its support to help address this need.

Modern research facilities are also needed to provide care and housing for chimpanzees that were originally bred for AIDS research. So far, chimpanzees have not

proven to be suitable models for studies of AIDS pathogenesis, but they are essential for studies of respiratory syncytial virus, hepatitis, malaria, and possibly for

AIDS vaccine and gene vector development. To consolidate the NIH-supported

chimps into just two or three sites, animal housing must be constructed to provide

cost-effective facilities that will assure the well-being and safety of the animals and

people who work with them. Funding to construct a chimpanzee sanctuary system

is also needed to accommodate chimpanzees no longer eligible or required for research.

NCRR proposes to increase the level of support for the Animal Facilities Improvement Program. About half of all NIH research grants include animal research models and institutions need to build specially adapted, modern research facilities to accommodate these genetically altered rodents. A special initiative to upgrade the research animal facilities of minority graduate and health profession schools will be

continued to help those institutions meet PHS standards and receive accreditation

by the Association for Assessment and Accreditation of Laboratory Animal Care

(International).

Through the Biomedical Research Infrastructure Network (BRIN), the NIH’s Institutional Development Award program enhances the educational infrastructure

and research capacities of institutions within 23 eligible States and Puerto Rico. The

BRINs provide support for laboratory renovation and scientific equipment, as well

as the recruitment and support of faculty at eligible institutions. In fiscal year 2002,

NCRR proposes to further develop the BRINs that were initially established in fiscal
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year 2001. In addition, those States that did not receive a BRIN award in fiscal year

2001 will have a special opportunity to compete for this award in fiscal year 2002.

The NIH budget request includes the performance information required by the

Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal

year 2000 results to the goals in our fiscal year 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify

strategies and objectives to continuously improve its programs.

My colleagues and I will be happy to respond to any questions you may have.

PREPARED STATEMENT OF JACK WHITESCARVER, PH.D. ACTING DIRECTOR, OFFICE OF

AIDS RESEARCH

Mr. Chairman and Members of the Committee: I am pleased to present the President’s budget request for the AIDS research programs of the NIH for fiscal year

2002, a sum of $2,501 million, an increase of $258 million above the comparable fiscal year 2001 appropriation. The NIH budget request includes the performance information required by the Government Performance and Results Act (GPRA) of

1993. Prominent in the performance data is NIH’s second annual performance report which compares our fiscal year 2000 results to the goals in our fiscal year 2000

performance plan. As performance trends on research outcomes emerge, the GPRA

data will help NIH to identify strategies and objectives to continuously improve its

programs.

The National Institutes of Health (NIH) represents the largest and most significant single public investment in AIDS research in the world. It supports a comprehensive program of basic, clinical, and behavioral research on HIV infection and

its associated opportunistic infections and malignancies to better understand the

basic biology of HIV, develop effective therapies to treat it, and design interventions

to prevent new infections from occurring. This research is conducted through intramural and extramural studies in the U.S. and around the world, sponsored by nearly all of the NIH Institutes and Centers. Each NIH component supports HIV/AIDSrelated research activities, consistent with its individual mission. It is the role of

the Office of AIDS Research (OAR) to plan and coordinate this research, setting the

scientific agenda and the budget necessary for this large and diverse NIH AIDS research program.

THE EXPLODING PANDEMIC

The AIDS pandemic is the greatest international challenge of our generation. HIV

has infected more than 50 million people around the world. AIDS already has killed

more than 21 million people, surpassing tuberculosis and malaria as the leading infectious cause of death worldwide, according to data released by the Joint United

Nations Programme on HIV/AIDS (UNAIDS) in the ‘‘AIDS Epidemic Update: December 2000’’ and the World Health Report 2000 of the World Health Organization

(WHO). (Chart 1)

The impact of AIDS on developing nations and many former communist countries

is staggering, with even greater potential disaster to come. AIDS is reversing decades of progress from important public health efforts, lowering life expectancy, and

significantly affecting education, food supplies, and international businesses. Lost

productivity and profitability, the cost of sickness and death benefits, and the decline in a skilled workforce in the developing world will have economic effects worldwide. AIDS is affecting the military capabilities of some countries as well as the

international peacekeeping forces. In Africa, the epicenter of the pandemic, AIDS is

killing ten times as many people as war, sabotaging economic development, leading

to massive social breakdown, and creating a generation of orphans. (Chart 2)

If the global spread of HIV/AIDS continues unchecked, South and Southeast Asia,

and perhaps China will follow the disastrous course of sub-Saharan Africa. Rapid

increases also are occurring in Eastern Europe and Central Asia, and AIDS remains

a serious threat in Latin America and the Caribbean. During the year 2000, more

new HIV infections were registered in the Russian Federation than in all previous

years of the epidemic combined.

THE EVOLVING EPIDEMIC IN THE UNITED STATES

In the United States, the HIV/AIDS epidemic continues to evolve. Although the

incidence of new AIDS cases has declined, attributed largely to expanded use of new

antiretroviral therapies that prevent progression of HIV infection to AIDS, the decline in death rates observed in the late 1990s has leveled off. Further, according
375

to the Centers for Disease Control and Prevention (CDC), the rate of new HIV infections has been constant at approximately 40,000 new cases each year since 1990,

meaning that the overall epidemic is continuing to expand. In fact, HIV infection

rates are continuing to climb in a number of subpopulation groups, such as women,

racial and ethnic minorities, young homosexual men, individuals with addictive disorders, and people over 50 years of age. The appearance of multi-drug resistant

strains of HIV presents a serious public health concern. These data forebode an epidemic of even greater magnitude in the coming years, and they shape our most urgent research priorities.

COMPREHENSIVE AIDS RESEARCH PLAN AND BUDGET

The OAR develops an annual comprehensive trans-NIH AIDS research plan and

budget to address these priorities, based on the most compelling scientific opportunities that will lead to better therapies and prevention for HIV infection and AIDS.

The planning process is inclusive and collaborative, involving the NIH institutes as

well as non-government experts from academia, foundations, and industry, with the

full participation of AIDS community representatives. The plan provides objectives

and strategies for the five Scientific Areas of Emphasis of AIDS research: Natural

History and Epidemiology; Etiology and Pathogenesis; Therapeutics; Vaccines; and

Behavioral and Social Science; as well as for key Areas of Special Interest, which

cross-cut all of the scientific areas: Racial and Ethnic Minorities; International Research Priorities; Training, Infrastructure, and Capacity Building; and Information

Dissemination. This year, the OAR also led an NIH effort to develop a strategic plan

for microbicide research, which will become an integral part of the overall plan. In

addition, the fiscal year 2003 plan, now underway, will include a new section devoted to research priorities for AIDS in Women and Girls. The Plan serves as the

framework for developing the NIH AIDS budget for each Institute and Center, for

determining the use of NIH AIDS-designated dollars, and for tracking and monitoring those expenditures.

Four major themes frame the fiscal year 2002 NIH Plan for HIV-Related Research: prevention research to reduce HIV transmission here in the United States

and around the world; therapeutic research to treat those who are already infected;

international research priorities, particularly to address the critical needs in developing countries; and research targeting the disproportionate impact of AIDS on minority populations in the United States. All of these efforts require a strong foundation of basic science, the bedrock of our research endeavor.

PRIORITY: PREVENTION RESEARCH

The transmissible nature of HIV makes it radically different from non-transmissible diseases such as heart disease and cancer. The transmissibility of HIV—

between individuals and across borders and populations—is what most defines the

global pandemic and makes it imperative that the U.S. help address prevention and

treatment needs worldwide. The transmissibility of the infection means that there

is the potential for unlimited global spread. But it also means that, with the development of appropriate biomedical and behavioral interventions, there is the possibility for dramatic reductions in new infections—and ultimate control of the pandemic—in a way that will not be possible for noninfectious diseases.

NIH supports a comprehensive approach to HIV prevention research that includes

contributions from the biomedical, behavioral, and social sciences. The OAR prevention science research agenda targets interventions to both infected and uninfected

at-risk individuals to reduce HIV transmission. Our biomedical prevention research

priorities include the development of topical microbicides, strategies to prevent

perinatal transmission-including a better understanding of risk associated breastfeeding-and management of sexually transmitted diseases. NIH also supports behavioral research strategies, including prevention interventions related to drug and alcohol use and risky sexual behaviors. Efforts continue to identify the most appropriate intervention strategies for different populations and sub-epidemics in the U.S.

and around the world.

PRIORITY: VACCINE RESEARCH

A safe and effective HIV preventive vaccine is essential for the global control of

the AIDS pandemic. NIH funding for HIV vaccine research increased by more than

170 percent between fiscal year 1997 and fiscal year 2002, resulting in the award

of new grants to foster innovative research on HIV vaccines, including vaccine design and development, and the invigoration and reorganization of the NIH vaccine

clinical trials effort. (Chart 3) Construction of the new intramural Vaccine Research

Center has been completed. In February 1999, NIH-supported investigators initiated
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the first AIDS vaccine trial in Africa. The investment in this area over the past few

years will have enormous significance, not only for AIDS research but for other diseases as well, as progress made in the development of an AIDS vaccine will have

implications for vaccines against other life-threatening illnesses.

PRIORITY: TREATMENT RESEARCH

Today, many HIV-infected people are living with the benefits resulting from NIHsupported research in this area. The development of combination regimens including

protease inhibitors has extended the length and quality of life for many HIV-infected individuals in the United States and Western Europe. Unfortunately, however, highly active antiretroviral therapy (HAART) has failed to eradicate HIV, and

a growing proportion of patients receiving therapy experience treatment failure.

Some patients find it difficult or impossible to comply with arduous treatment regimens, develop toxicities and side-effects, or cannot afford their high cost of approximately $15,000 per year. Others fail to obtain a satisfactory reduction in viral load

even while adhering to treatment regimens. In addition, metabolic complications, including insulin resistance, and body composition changes such as deforming deposits

of abdominal adipose tissue, have emerged in individuals who have been on longterm antiretroviral regimens. Finally, an increasing number of treatment failures

are linked to the increasing emergence of drug-resistant HIV. Thus, the need for

simpler, less toxic, and cheaper drugs and drug regimens to treat HIV infection and

its associated opportunistic infections (OIs), malignancies, and other complications,

continues to be a high priority. (Chart 4)

PRIORITY: INTERNATIONAL RESEARCH

To address the increasing urgency of the global AIDS pandemic, the OAR has established a new initiative and strategic plan for global research on HIV/AIDS aimed

at slowing the disaster and reversing its destruction of communities, economies and

nations worldwide. The Global AIDS Research Initiative and Strategic Plan reaffirms NIH’s long-standing commitment to international AIDS research and will significantly increase research efforts in the coming year to benefit resource- and infrastructure-poor nations. NIH supports a growing portfolio of research conducted in

collaboration with investigators in developing countries. Results of this research

benefit the people in the country where the research is conducted as well as people

affected by HIV/AIDS worldwide. It is critical to the success of international studies

that foreign scientists be full and equal partners in the design and conduct of collaborative studies and that they have full responsibility for the conduct of studies

in-country. To that end, NIH supports international training programs and initiatives that help to build infrastructure and laboratory capacity in developing countries where the research is conducted.

PRIORITY: RACIAL AND ETHNIC MINORITIES

Research to address the disproportionate impact of the HIV/AIDS epidemic on

U.S. racial and ethnic minority communities (Chart 5) continues to be a high priority. We are directing increased resources toward new interventions that will have

the greatest impact on these groups. These include interventions that address the

co-occurrence of other STDs, hepatitis, drug abuse, and mental illness; and interventions that consider the role of culture, family, and other social factors in the transmission and prevention of these disorders in minority communities. NIH is making

significant investments to improve research infrastructure and training opportunities for minorities, and we will continue to assure the participation of minority subjects in AIDS clinical trials as well as in natural history, epidemiologic, and prevention studies. OAR has provided additional funds to projects aimed at: increasing the

number of minority investigators conducting behavioral and clinical research; targeting the links between substance abuse, sexual behaviors and HIV infection; increasing outreach education programs targeting minority physicians and at-risk

populations; and expanding our portfolio of population-based research. One of these

projects is a series of Training and Career Development Workshops for racial and

ethnic minority investigators.

PRIORITY: BASIC SCIENCE

Of paramount importance in our fight against HIV/AIDS is maintaining a strong

commitment to basic research. Tremendous progress has been made in understanding the fundamental steps in the life-cycle of HIV, the host-virus relationship

and the clinical manifestations attending HIV infection and AIDS. Groundbreaking

research on basic HIV biology and AIDS pathogenesis has revolutionized the design
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of drugs, the methodologies for diagnosis, and the monitoring for efficacy of antiviral

therapies. Thus, OAR will continue to devote a substantial portion of NIH AIDSrelated research funds to fundamental biomedical, behavioral, and social science research.

SUMMARY

The worldwide human and economic toll of this insidious disease is profound, and

we will never solve the problem of AIDS for our own citizens without controlling

the epidemic in the rest of the world. The nation’s investment in AIDS research is

reaping even greater dividends, as AIDS research is unraveling the mysteries surrounding many other infectious, malignant, neurologic, autoimmune and metabolic

diseases. We deeply appreciate the support of this Committee for our efforts.

THE EXPLODING GLOBAL HIV/AIDS PANDEMIC

[In millions]

Group

People

newly infected in

2000

People living with

HIV/AIDS

AIDS

deaths in

2000

Total AIDS

deaths

Adults .................................................................................... 4.7 34.7 2.5 17.5

Women .................................................................................. 2.2 16.4 1.3 9.0

Children ................................................................................ .6 1.4 .5 4.3

Total ........................................................................ 5.3 36.1 3.0 21.8

Source: UNAIDS
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Senator SPECTER. We have been joined by my distinguished colleague, Senator Thad Cochran.

Senator Cochran, do you care to make an opening statement?

OPENING STATEMENT OF SENATOR THAD COCHRAN

Senator COCHRAN. Well, Mr. Chairman, thank you. I join you in

welcoming Dr. Kirschstein thanking her in joining us for this discussion of the budget for the fiscal year 2002 for NIH.

I think she deserves our commendation, too, for her service to

the National Institutes of Health, particularly during this recent

transition period, but this budget is a very important step toward

our goal of doubling the NIH budget by the year 2003. It addresses

very oppressing health needs in our country, and around the world,

as a matter of fact.

There are two areas I hope to see the Institutes address during

this year. We have to deal with the disparities in under-served

areas of our country, as well as funding disparities. The IDeA program is one way of enhancing research effort in my part of the

country, where NIH research has not traditionally been conducted.

It is interesting to note that these are also some of the same areas

with glaring health disparities. The IDeA program has the potential to improve the health of millions of needy patients in these

areas.

An additional area of concern for me is bio-imaging and radiology

research. The newly authorized National Institute of Bio-Imaging

and Bio-Engineering will require a transfer of existing radiology

and bio-engineering research to this new institute. We are looking

forward to working with you and helping to provide you the benefit
380

of our counsel and advice. Thank you again for being here, and for

your dedicated work for millions of Americans.

Thanks, Mr. Chairman.

Senator SPECTER. Thank you very much, Senator Cochran.

Dr. Kirschstein, a question which is repeatedly posed to me by

my colleagues is, are we providing too much money too fast to the

National Institutes of Health. What are your best assurances, as

specific as you can be, that this rapid increase in your budget is

being put to good use?

Dr. KIRSCHSTEIN. Mr. Chairman, the scientific opportunities are

immense, and they have been for some time. The increases that the

Congress has provided to the National Institutes of Health have

been put to extraordinarily good use over the last several years.

Programs in clinical research that could not possibly be started

before have been begun, in drug abuse, in heart disease, new testing of vaccines, new testing of therapies for HIV AIDS, new studies

in cancer. Dr. Klausner can describe several new drugs that have

been developed, as can all my colleagues.

The momentum is there. What is needed is to continue to make

progress, because every question that is answered leads to several

more questions that need to be answered, and this is a moment of

enormous opportunity.

Senator SPECTER. Is $3.4 billion sufficient to utilize and follow all

of the existing leads?

Dr. KIRSCHSTEIN. Mr. Chairman, I think that the increase that

the administration has given us is very fine, indeed. It is 13.5 percent, $3.4 billion would be even more, clearly, but I think we could

use those funds extremely well. We have investigators who are full

of burgeoning ideas. We have clinical trials that we want to do.

We need to do some work in the states that Senator Cochran is

talking about. Our BRIN program has been started, and the Senator knows. I came down and saw him last week, and we have all

sort of wonderful opportunities. I would like to give my colleagues

a chance to tell you about them, if possible.

Senator SPECTER. You pick the first colleague to give us as specific an illustration as he or she can as to what this additional

funding has meant.

Dr. KIRSCHSTEIN. Dr. Klausner.

Senator SPECTER. We heard from Dr. Klausner 10 days ago, and

we know his answers.

Dr. KIRSCHSTEIN. In that case, I will go to Dr. Lenfant. Either

way.

Senator SPECTER. Go ahead, Dr. Klausner.

Dr. KLAUSNER. Senator, just in case you forgot, over the last couple of years, with the increase in funding, we have been able to do

a variety of things, including beginning to change the entire way

cancer is diagnosed, as we talked about a few weeks ago, switching

from a hundred years of pathologic diagnosis alone, to the new molecular diagnosis.

We are suddenly discovering rapidly that there are new types of

cancers that we only imagined exist, we now see exist. For the first

time, with that, we can align therapies to the appropriate diagnosis.
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Senator SPECTER. Dr. Klausner, you testified at the hearing on

breast cancer about the impact of stem cells. I think it would be

good for you to summarize that here this morning.

Dr. KLAUSNER. Yes. What I pointed out is that in cancer we believe that there are two types of opportunities in stem cells. Of

course, in cancer research we have been using stem cells to replace

organs, generally, the bone marrow, that are damaged, either because of disease, or, more commonly, therapy.

The two areas of promise with stem cell research for cancer are,

one, understanding the fundamental biology which underlies cancer, and that is, how do cells make the decision to either keep proliferating, or to differentiate. That fundamental switch which

underlies stem cell biology is, we believe, fundamental to understanding the switches that lead to cancer cells.

The other issue in cancer is the fact that until we have better

therapies currently, cancer itself, or the therapies, are often quite

destructive of tissues, or particular organs, and stem cells, as they

have been used successfully in cancer therapy, hold the promise of

regenerative approaches to deal with the damage due to therapy or

the disease.

ADULT STEM CELL EXPERIMENT

Senator SPECTER. Dr. Lenfant, I am turning to you next. As Dr.

Kirschstein suggested. Thank you for the response to my letter, in

which you had pointed out that in the next 5 years it’s projected

that there will be an ability to engineer tissues for damage heart

valves, muscles, and blood vessels, and the delivery of therapeutic

genes, and in 10 years, projecting complete heart ventricles, regeneration of cardiac tissue, and organ growth in infants born with

cardiovascular malformations. That is very good news, indeed. To

what extent do the stem cells play a part in that?

Dr. LENFANT. Well, so far, Mr. Chairman, we have been developing a fairly significant experiment in the use of adult stem cells

and the results have been extraordinarily exciting and significant,

as to what you were mentioning, the recreation of tissues which

have been damaged, and quite successfully in the formation of new

valves, new blood vessels. And in the case of, say, heart failure,

which is the ultimate complication, so to speak, of the repeated

heart attack, we can now regenerate some heart cells, and restore

some of the functionality of the myocardium, which has been damaged by a repeated heart attack.

Senator SPECTER. Why do you particularize adult stem cells, Dr.

Lenfant?

Dr. LENFANT. Excuse me?

Senator SPECTER. Why did you specify adult stem cells?

Dr. LENFANT. Because so far that is the only experience that we

have, Mr. Chairman.

Senator SPECTER. Have you not had stem cells available from

embryos?

Dr. LENFANT. No. No. Not in our areas of research. They have

not been used.
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EMBRYONIC STEM CELL POTENTIAL

Senator SPECTER. We have had expert testimony that embryonic

stem cells offer a great deal more flexibility and ability to differentiate that is much superior to adult stem cells. Would you agree

with that?

Dr. LENFANT. Yes, I would agree with that. In my scientific opinion, it is something that needs to be explored, but so far it has not

been done, and all the comments that I can make are on the basis

of what we have learned from other stem cells.

Senator SPECTER. Well, I think it is very good news, indeed, to

people who have heart disease what you have accomplished, and

what you have the prospects to accomplish beyond.

My red light went on, so I will turn to my colleague, Senator

Cochran.

Senator COCHRAN. Mr. Chairman, I have some specific questions

about the IDEA program, and some other issues, which I am prepared to submit for the record, and let you move along. You have

a lot of people here, and I have another commitment that requires

me to leave now, but I appreciate your conducting the hearing, and

having everyone here for the committee.

Senator SPECTER. Thank you very much for joining us, Senator

Cochran. I appreciate it.

The issue of stem cells, I know, has been very much in the forefront of Parkinson’s. Dr. Audrey Penn, a question that I have asked

in each of our previous sessions has been ‘‘When,’’ and we had an

estimate within 5 years to conquer Parkinson’s. In light of all of

the money you have gotten for research, how far can you advance

that completion date?

That is what you call a leading loaded question, Dr. Penn. You

can handle it any way you like.

Dr. PENN. I hope we can advance it. There are two responses to

your question on record. One was 5 years and one was 10 years,

I will not claim either one, but we feel that we are moving very

quickly on measures that will control this disease much better than

we have ever done before. A cure is going to be harder, as we know,

and it will take a little longer. There are several issues.

In terms of the stem cell question, we have evidence already

using stem cells or precursor cells in mouse models that we can

really impact the types of models of Parkinson’s Disease that we

already have, these are chemically induced models, but the response is tremendous.

We have not yet moved beyond that, and there may be another

way. There may be a way of using the cells already resident in the

brain to mobilize them. There is already evidence that that can be

done. We hope that we can do this, because it solves things like

gene therapy, it solves things like putting special factors in that

could help those cells that are left to work. We very much think

that this is a way of approaching the problems we are having in

really curing this disease.

Senator SPECTER. Let me move quickly to a couple of other

questions——

Dr. PENN. Yes, sir.
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Senator SPECTER [continuing]. Dr. Penn. Amyotrophic lateral

sclerosis, what is the progress there, and to what extent are the

stem cells implicated there?

Dr. PENN. I would say, sir, that there is a group organized by private donors that are very much involved in doing just this, and

they are making progress working with some of the best investigators in the country.

Senator SPECTER. On stem cells——

Dr. PENN. They are monitoring this. They are working with stem

cells.

Senator SPECTER. And they are private donors?

Dr. PENN. They are private donors, and they have a very specific

target, as you can well imagine.

Senator SPECTER. What are the prospects for delaying the onset

of ALS?

Dr. PENN. I do not know that this approach will delay the onset,

but it certainly could put back working motor neurons, so that this

disease could be slowed way down. The whole group in the

amyotrophic sclerosis community is very much involved in doing

clinical trials.

They want to do clinical trials as soon as possible with almost

anything that will work, so they are organized and mobilized. We

are still trying to put pertinent factors back in the spinal cord, but

there is some very interesting evidence that stem cells may work.

Senator SPECTER. And Alzheimer’s comes within your branch as

well.

Dr. PENN. Yes, it does. Again, Dr. Hodes and NIA is the primary

institute dealing with Alzheimer’s disease.

ALZHEIMER’S DISEASE RESEARCH

Senator SPECTER. Well, let me turn to him then, sort of spend

around the speaking parts, and ask you, Dr. Hodes, for your evaluation as to what progress we are making on Alzheimer’s, and to

what extent the research is moving ahead, and if stem cells factor

in there.

Dr. HODES. Thank you for the opportunity. If you will remember,

we had the chance to speak with you before a hearing here not so

long ago, during which there was a summary of the very dramatic

progress in Alzheimer’s research over the past years. The identification of genetic and molecular underpinnings of the disease has

very directly been translated now into new approaches to treatment.

They include attempts to actually interfere with some of the molecules, enzymes that cause some of the toxic products in the disease. You heard in particular about an approach to immune therapy, or vaccination, against Alzheimer’s peptide, that is very exciting.

In terms of the role of stem cells, there has been very exciting

news over the past year indicating that in some of the areas of the

brain that are affected by Alzheimer’s, there is, indeed, stem cell

activity, the sort Dr. Penn referred to, that is stem cell activity

resident within the brain. One approach is to try to trigger differentiation of these very cells in the brains of individuals affected,

and repair damage caused.
384

In addition, there is work that has been occurring in animal

models in which cells from a variety of sources unexpectedly have

been shown to have the capacity, for example, bone marrow stem

cells, to differentiate into stem cells for neurons, which can, indeed,

repopulate the brain. So these are some very recent and exciting

findings, which suggest that stem cells from a variety of sources

may be capable of differentiating into functional neurons in the

brain, and provide relief, or even prevention for Alzheimer’s disease.

Senator SPECTER. Let me turn now to Dr. Allen Spiegel, Diabetes

Institute. The question is: I understand that the stem cells have

been very instrumental in moving ahead on diabetes. Can you

bring us up to date on that, please?

ISLET TRANSPLANTS IN TYPE 1 DIABETES

Dr. SPIEGEL. I would be happy to, Chairman Specter. As you

know, and as we discussed with your colleague, Senator Harkin,

the Edmonton trial in Canada has demonstrated that islet transplantation can be a successful potential cure for type 1 diabetes.

The follow-up for this trial was updated just in April in a paper

published in the journal Diabetes, which indicated that 11 of the

12 people receiving these islet transplants are still insulin independent. This is very promising.

This protocol is being replicated in NIH-supported studies

around the country, and at the NIH Clinical Center there has already been experience with four such patients, again, showing

some success.

INADEQUATE SUPPLY OF ISLETS

This is the good news. However, roughly 1,000 donor cadaveric

pancreases, from which these islets are harvested, are insufficient

to ever meet the need for the roughly million type 1 diabetics. This

is why we are working intensively on many, many approaches to

providing the supply of islets. Stem cell work is very important in

this regard.

STEM CELL RESEARCH

I will summarize briefly some of the progress to date of which

I am aware. Mouse adult stem cells, derived from the pancreatic

ducts, have been used in an experimental study published in Nature Medicine to reverse type 1 diabetes in the mouse model. That

has not been replicated, and there have been some concerns as to

whether there are really adequate amounts of insulin produced.

In human efforts for adult stem cells coming from the pancreatic

duct, investigators at the Joslin Clinic, whom we support, have isolated such adult stem cells that can turn into islets, but unfortunately, the amounts, to date, are inadequate.

Senator SPECTER. The amount of what is inadequate?

Dr. SPIEGEL. These cells are precursors in the pancreatic ducts

from adult pancreases that are cadaveric pancreases, grown into

islet-like clusters, and unfortunately, the amounts generated, according to the investigators in that paper, are as yet inadequate to

be useful.
385

Senator SPECTER. The amount of adult stem cells?

Dr. SPIEGEL. That is correct, according to those investigators.

Senator SPECTER. Do you concur with Dr. Lenfant that the embryonic stem cells would be superior?

Dr. SPIEGEL. I cannot give you a simple answer to that, but I can

tell you about work on mouse embryonic stem cells, which is what

I was coming to.

The mouse embryonic stem cell work, which can be supported by

NIH, was actually done intramurally in the National Institute of

Neurological Disorders and Stroke. Researchers demonstrated in a

very, very exciting fashion that they could differentiate these

mouse embryonic stem cells into islet-like clusters. Unfortunately,

these cells made about a fiftieth of the amount of insulin of a normal beta cell, and they were inadequate to be able to cure diabetes

in a mouse model. This is work of Dr. Ron McKay and colleagues,

published in Science.

As far as human embryonic stem cell work, undoubtedly it is

going on in the private sector, perhaps in foreign countries, but because there are no publications that I am aware of, I cannot really

comment.

Finally, I would comment on the work with bone marrow stem

cells. We have heard so much about their plasticity—the fact that

they can turn into so many other kinds of stem cells. However as

yet, to my knowledge, there is no evidence that they turn into islet

cells—liver cells, possibly, but not islets.

In summary, we just do not know at this very early stage of investigation which of the two types of cells—adult stem cells or embryonic stem cells—would be superior. I think, as a scientist, that

one has to be cautious and not make pronouncements when there

is no sort of adequate data yet.

Senator SPECTER. Would you like to have the availability of embryonic stem cells to at least find out?

Dr. SPIEGEL. That is something that is under review by the Administration, and I think we will have to see how that works out.

Senator SPECTER. Excuse me, but what does that have to do with

my question, what the administration wants to do? I am asking

you as a scientist, would you like to have embryonic stem cells

available.

Dr. SPIEGEL. What I can certainly say is that a number of scientists, I think there were 80 Nobel Laureates, that I am aware

of, have articulated the desire to be able to compare these. I think

scientists around the country in the various centers have said exactly that. As a scientist, yes, I think we would like to be able to

do this.

Senator SPECTER. That is what I was looking for, as a scientist.

Dr. SPIEGEL. Yes, absolutely, as a scientist, that is absolutely the

case.

USE OF STEM CELL IN VISION RESEARCH

Senator SPECTER. Let me move quickly before yielding to Senator

Harkin and get some comments from Dr. McLaughlin, of the Eye

Institute, with the focus on new cornea studies showing promise

with stem cells. Dr. McLaughlin, how about that?
386

Dr. MCLAUGHLIN. Yes, sir. That is probably, in the eye, field the

most advanced situation for stem cell transplantation. In conditions

such as alkaline burns, where the normal cells that would lead to

the clear cover——

Senator SPECTER. Speak more directly into the microphone,

please, Dr. McLaughlin.

Dr. MCLAUGHLIN. The cornea of your eye is covered by a single

layer of cells, and this is very important. If those cells are

unhealthy, your cornea will cloud, and you will not be able to see.

In situations, for example, like an alkaline burn, the cells that normally would produce those, that single layer of cornea cells, they

are destroyed.

So what investigators are doing, they are taking cells—this is

from adults—that are stem cells, or precursors to those cornea

cells, growing them up in culture, and then transferring them to

patients who have these various corneal problems, and so far the

results are very promising.

Senator SPECTER. Let me turn now to Dr. Stephen Katz, National Institute of Arthritis, Musculoskeletal and Skin Disease,

with respect to the stem cell treatment on arthritis, which, as I understand it, shows promise on pre-growth of skin, what is your

view of that, Dr. Katz?

Dr. KATZ. Thank you, Senator. In all of the areas of the interest

of the National Institute of Arthritis and Musculoskeletal and Skin

Diseases stem cells have shown promise including regenerating

cartilage cells in the joint in osteoarthritis, which is the most common form of arthritis. In the area of osteogenesis imperfecta, stem

cells have been shown to be effective in regenerating some of the

bone-forming cells.

In the muscular dystrophies, stem cells in work that has been

supported by the Neurology Institute, as well as our institute, have

shown promise in what are called satellite cells, which are thought

to be stem cells of muscle, to regenerate those muscle cells. We

know also that in skin, stem cells are very important, as Dr.

McLaughlin said, to regenerate epithelium that covers the skin.

Senator SPECTER. Let me turn now to Dr. Anthony Fauci, Allergy

and Infectious Diseases, with respect to the stem cell treatment on

AIDS.

Dr. FAUCI. Senator—thank you for the question.

One of the characteristics of HIV/AIDS disease is a rather dramatic and catastrophic depletion of immune system functions, specifically a very important cell of the immune system. Similar to the

reconstitution of bone marrow that Dr. Klausner alluded to just a

few moments ago in patients who are treated for cancer, the same

would hold true with regard to the reconstitution of the human immune system by stem cells. Stem cell research is very much at the

forefront of the ideas of individuals who are planning strategies.

Once you get the virus under control with anti-retroviral therapy,

to help the immune system, which might not be able to spontaneously regenerate itself, it may be possible to help the immune system to regenerate itself by providing it with these precursor cells.

Senator SPECTER. Dr. Kirschstein, let me come to this question

about their letters and the late arrival, and then I will turn to my

distinguished colleague, Senator Harkin.
387

We did not get the responses until yesterday afternoon at 3:45.

There were 42 pages, as I understand it, instead of 70. Why such

a late return?

Dr. KIRSCHSTEIN. Mr. Chairman, the Institute directors received

your letter on May 4th, and they were assigned for completion to

the various institutes, to be returned to the central focus, the Executive Secretariat of NIH, by May 9th. I met you at the event for

the Society for Women’s Health, and told you, as I had told Ms.

Taylor, that I was going to send those letters for clearance, which

is the policy, to the department.

Our responses, except one, which was delayed, were sent to the

department for clearance on May 14th, and we did it—by the way,

we always send such responses through the NIH Executive Secretariat, from our Executive Secretariat. At that point, the work was

to be done, whatever, in the department for clearance.

Senator SPECTER. Well, I am told that the letters were rewritten

in the department, is that true?

Dr. KIRSCHSTEIN. Yesterday, I was called, and asked whether the

letters, which had been reviewed, when there was an issue as to

whether letters from individual Institute directors raised issues

more broadly than the mission of that institute, would the Institute

directors consider narrowing their focus to their own mission, and

talking strictly about the scientific aspects, which is what I think

we always address.

I had a meeting with the Institute directors, and asked each of

them to review what they had said, and see whether they wished

to, in any way, modify the letters, based on whether they thought

their letters were more broad ranging. The letters were then——

Senator SPECTER. Whether their letters were what?

Dr. KIRSCHSTEIN. More broad ranging than focusing on the particular mission of the Institute. Each of the Institute directors then

reviewed their letters, and some made changes, and some did not.

Senator SPECTER. Well, this subcommittee would like to get copies of the original letters and a copy of the modifications. It has

been reported to me that the instructions were given, quote, ‘‘The

answers and questions based on science, and not on political speculation or personal views,’’ closed quote. Is that accurate?

Dr. KIRSCHSTEIN. It was not on speculation, but it was on following the mission of the Institute. The term ‘‘personal views’’ was

never told to me; it was never mentioned to me.

Senator SPECTER. Mr. Whitaker, Assistant Secretary for Legislative Affairs, I understand, is present. Would he step forward,

please?

Come up front. We can make a place for you at the head table.

Mr. WHITAKER. Okay.

Senator SPECTER. Why the long delay, Mr. Whitaker?

Mr. WHITAKER. Honestly, Mr. Chairman, first of all, I want to

apologize to you for the delay, but I also want to assure you that

there was in no way an attempt on the Office of the Secretary’s

part to withhold information or control the information that was

sent to you.

[CLERK’S NOTE.—Page 27–32—Mr. Whitaker’s office, Assistant Secretary for Legislation, informed ASMB that the letters and an explanation concerning the distribu-
388

tion of the letters were sent to the Committee the end of May, we were not informed

of the exact date.]

Senator SPECTER. Well, I am interested in your conclusions—

Mr. WHITAKER. It was simply——

Senator SPECTER [continuing]. But only a little. Let me find out

what the facts are here. Why the delay? What happened? Were

those letters submitted on May 14th, as Dr. Kirschstein testified?

Why the delay?

Mr. WHITAKER. I was told by our Executive Secretariat, which is

the part of the Department that controls correspondence for the entire department——

Senator SPECTER. And who is that?

Mr. WHITAKER. Anne Agnew is our executive secretary. Some of

the letters were received on the 14th, but not all the letters, and

that she——

Senator SPECTER. But not what?

Mr. WHITAKER. Not all of the letters were received on the 14th

from the Institute directors.

Senator SPECTER. Is that true, Dr. Kirschstein?

Dr. KIRSCHSTEIN. I believe, from what I know, that all of the letters, except one, were received on the 14th. The National Cancer

Institute was working on its letter, and it came in 1 day later.

Senator SPECTER. So one letter was 1 day late, is that so, Mr.

Whitaker?

Mr. WHITAKER. That is not what I have been told by the Executive Secretariat. I do not control that information. The information

is only passed on to me. I am told that the final letter did not come

in until——

Senator SPECTER. I want you to pursue that and find out whether Dr. Kirschstein is correct or not——

Mr. WHITAKER. Yes.

Senator SPECTER [continuing]. And submit a written response

within a week, please.

Mr. WHITAKER. I will do that, sir.

Senator SPECTER. So how about the letters that were submitted?

Why were they not transmitted to the subcommittee?

Mr. WHITAKER. As a matter of policy, the Secretary has asked for

the right to review correspondence to Congress, as well as testimony to Congress, and those letters were received in the Office of

Legislation on Thursday night, and on my desk on Friday evening.

Senator SPECTER. Which Thursday and which Friday?

Mr. WHITAKER. This past Thursday. The date would have been

the 17th. Then I saw the letters the following Friday evening.

Senator SPECTER. What happened to them between Monday and

Friday?

Mr. WHITAKER. I do not know, sir. The letters were——

Senator SPECTER. Would you find out for me?

Mr. WHITAKER. I will find out. My assumption is that the letters

were at the Executive Secretariat’s office, and they were probably

being compiled so that they had a complete package to forward to

the Office of Legislation. That is my guess as to——

Senator SPECTER. Were there any requests made for modification

by——
389

Mr. WHITAKER. We made no specific requests to modify any of

the letters. We simply asked——

Senator SPECTER. Aside from a specific request, did you make a

generalized request?

Mr. WHITAKER. We made a generalized request that we thought

it would be best that the letters be focused on the science, and the

science only, and that——

Senator SPECTER. Well, what were the letters focused on, that

these scientists were not writing the letters based on science?

Mr. WHITAKER. I believe, and Dr. Kirschstein talked to me about

this, and to our chief of staff, and Dr. Kirschstein agreed, that

some of the letters may have gone beyond exactly what the mission

of each institute was, and based on some non-scientific speculation,

and Dr. Kirschstein——

Senator SPECTER. These letters had non-scientific speculation.

Mr. WHITAKER. That was my understanding from my conversation with Dr. Kirschstein.

Senator SPECTER. Would you make available to this subcommittee the specifics as to what you are talking about, what letters you received, and what you considered non-scientific speculation?

Mr. WHITAKER. As a general rule, sir, we receive draft letters

from all agencies, from HCFA, to AOA, to NIH, to CDC, for review.

These come to us in the form of draft letters for us to review, and

that is general policy——

Senator SPECTER. I am not so much interested in that as I am

in response to my question. Will you submit to this subcommittee

the letters which you concluded were based on speculation?

Mr. WHITAKER. I will go back and look at those letters, sir, and

I will get a response to you.

Senator SPECTER. Will you submit those letters to this subcommittee?

Mr. WHITAKER. I would be happy to do that, sir. I obviously

would have to clear that with the Secretary.

Senator SPECTER. Well, let me be direct in my concerns here.

This subcommittee is interested in what the potential for stem cells

may be, and we want the scientific facts. When I get a report that

the answers to my questions are based not on science, but on political speculation and personal views, closed quote, I am more than

a little concerned. This would be an indication of the kind of scientists which we have here, if the responses were not based on

science.

If you, top-flight men and women, do not respond to the subcommittee based on science, I have a hard time understanding why

we are appropriating $24 billion for you. You are scientists, and I

would expect you to submit answers based on science, and I would

be shocked if you did not, because I know your caliber and your

qualifications.

So I want to see what those responses are, whether they are

based on science, or maybe some of you did not like the answers.

Then when it goes on to say not on political speculation, well there

is no place for politics in the work in your unit, and I want to know

what the facts are on stem cells.
390

I have had a discussion with the President of the United States

on this subject, and he wants to know what the facts are, too, and

we want them unvarnished. I talked twice to the Secretary of

Health and Human Services about this matter. I was not very

happy, at mid-day, the day before this hearing, not to have those

letters.

There are other things on my agenda between yesterday afternoon and this morning, like voting in the United States Senate on

the tax bill. So I intend to get to the bottom as to what is going

on here. Really the basic consideration is what is the potential for

stem cells.

There is a political fight brewing over this matter, and it is going

to be decided in the Congress and by the President. When we have

these extra embryos created for in vitro fertilization, and they create more embryos than necessary. Some are going to be destroyed,

and there is an argument, a theological, philosophical, political argument about whether life is in existence. If life were to be created,

I would be the last one to say let us use these embryos for stem

cell research, but if they are going to be destroyed, it is another

matter. But that is something to be decided in the Congress and

by the President in accordance with our laws.

We can pass a bill, he can sign it or veto it, and we can override

the veto, if there are two-thirds necessary. That is the way these

judgments are made, but from you we would expect the facts and

the scientific evaluation. And from you, Mr. Whitaker, and your department, we would expect the transmission without editing and

alteration, but we will get the details as to what was originally

submitted, and whatever objections you had, and we will make our

own evaluation of that.

Senator Harkin.

Senator HARKIN. Thank you very much, Mr. Chairman. I will

just ask that my statement be made a part of the record.

[The statement follows:]

PREPARED STATEMENT OF SENATOR TOM HARKIN

Thank you, Mr. Chairman. You’ve been a great champion for medical research

over the years, and I thank you for holding this hearing.

Dr. Kirschstein, it’s a pleasure to welcome back you and your colleagues to testify

before this subcommittee. Most people probably don’t realize how important your

work is to their daily lives, and how lucky they are that you do it so well. But all

of us on this subcommittee are grateful for your extraordinary dedication and service.

A lot has happened since we met last spring to discuss the NIH budget for fiscal

year 2001. Two months after that hearing, NIH scientists announced the completion

of a draft sequence of the human genome—without a doubt, one of the most significant events of our lifetime.

And just two weeks ago, the NIH made another exciting announcement: the FDA

approval of the most promising cancer drug ever developed. This drug, called

Gleevec, was given to 54 patients with chronic myelogenous leukemia (CML), a disease in which too many white blood cells are made in the bone marrow. In 53 of

those patients, the disease basically disappeared. A year later, 51 of those patients

still had a normal blood count.

One thing that’s so exciting about this drug is its potential for fighting other diseases as well. As I understand it, Gleevec turns off the same molecular targets that

also cause some forms of cancer in the abdomen and brain. It’s hard to believe that

a single drug could work against three cancers that seem so different on the surface,

but that seems to be a real possibility.

And if it’s true, we might have to re-evaluate the way we think about the nature

of disease itself. Instead of describing a disease by where it shows up in the body—
391

the liver or the brain or the lung—the key issue is really what part of the molecule

is causing the problem.

This is exactly the kind of discovery that the NIH is all about. First, scientists

did basic research about how molecules work; then they translated it into a direct

application that could save thousands of lives.

And it’s an encouraging sign to those of us on this subcommittee who have supported the NIH over the years. When I first started talking about doubling NIH’s

budget back in the early 1990s, most people didn’t take that idea very seriously.

Now, thanks to the work of Chairman Specter and many others, it’s on the verge

of happening. Next year, fiscal year 2002, will be Year 4 of our five-year effort to

reach that goal.

The president has called for a $2.7 billion increase, but Chairman Specter and I

would like to boost that figure up to $3.4 billion. Of course, our ability to do that

will depend greatly on what kind of appropriations allocation we get; we certainly

weren’t helped by the budget resolution that Congress adopted earlier this month.

But I’m hopeful we’ll prevail.

And if we do, Dr. Kirschstein, I don’t need to remind you that the additional

money will bring added responsibilities—$3.4 billion means a lot more grants to

award, a lot more clinics to staff, and a lot more employees to manage. It will take

a great deal of vigilance to ensure that the money is spent wisely.

Again, Mr. Chairman, I want to thank you for holding this hearing, and I look

forward to Dr. Kirschstein’s testimony.

Senator HARKIN. I want to welcome Dr. Kirschstein and all of the

other directors, the scientists and administrators who are here

today.

First of all, let me just say for the record, Mr. Chairman, you

have been one of the great leaders in the entire Congress in pushing for medical research all the time I have known you, and all

these years, and I just want you to know that I appreciate that,

and I thank you for that, and I thank you for holding this hearing,

and for your strong support of unbiased, non-political interference

in scientific pursuits, and I want to thank you for that.

I just want you to know, I have just been listening to this, and

I know a little bit about this. If at any time that you would like

to issue a subpoena to go back and get those, you will have my

name on it.

Senator SPECTER. Thank you.

Senator HARKIN. I would be glad to support you in that, if you

would like to do that, if that becomes necessary. If that becomes

necessary, I will support you.

I was just thinking, again, Mr. Chairman, that years ago we had

a lot of political interference in terms of the budget coming up, especially from the National Cancer Institute. This is a number of

years ago, preceding me. So the Congress passed a law mandating

a by-pass budget. So every year we get a by-pass budget that we

get our hands on directly from the Institutes.

Well, maybe, Mr. Chairman, what we need to do is to ensure

that any requests for letters from any of the heads of any of the

Institutes that we request that comes to this appropriation subcommittee also has a by-pass that comes here, just like the by-pass

budget.

Now, if the political people, in whatever department, and whatever administration, want to tinker with it, that is their own business, but at least we should get the unvarnished truth without

going through it, so maybe we ought to think about how we—if we

ask, if this committee, you as chairman, me ranking member,

whatever, asks for information from an institute, that ought to be

transmitted, and it should not have to go through other kinds of
392

departments, just like a by-pass budget, and maybe we ought to

think about——

Senator SPECTER. Good point.

Senator HARKIN [continuing]. Changing the law in that regard.

We have a vote on, and I am sorry, I apologize, we are going to

have all these votes, and so I assume we are going to have to go,

right?

I just want to thank all of you for all of the tremendous work

you are doing in scientific research, the great leadership you have

shown. I wish we could have more time to go into a lot of these

things. I have as much support for stem cell research as my chairman does, and we are pretty much in lock step on this one.

A couple of things, and you do not even have to answer this, but

I perhaps need it in writing, Dr. Kirschstein, is, we have been

working hard to double the budget, we are going to get it done, it

is going to happen over the next couple of years, but the President’s budget, looking in the forward years, calls for a 2.2 percent

increase in 2004 and a 2.2 percent increase in 2005.

Now, that has important implications, because research grants

run about 4 years, and we want them to run longer than shorter

periods of time, so new grants that are awarded now will require

commitments through 2005. But if we come to a ledge and we drop

off, what is going to happen if, in fact, there will not be any money

left over for anything new?

In other words, if we use all that money for all the old grants,

what happens to the new grants that we want to start funding in

those out years? I am really concerned about that, and I do not—

we have to go. I do not know if you can respond to that shortly,

and——

Dr. KIRSCHSTEIN. I can give you a short answer, Mr. Harkin. We

are concerned, also, and so we are beginning to look at this, and,

indeed, I am putting together a committee of Institute directors.

Dr. Lenfant will chair the committee. We will have other Institute

directors. We will have Dr. Baldwin, who handles the day-to-day

activities of our extramural research program, and we will be working on this steadily, and we will have some plans sometime by the

summer.

Senator HARKIN. Okay. Two other quick things: The status of our

labs out there and extramural research. I will not go into all of the

studies and all of that data, but I am just going to say that right

now it is authorized at $250 million, and given the current situation, would it make sense for the NIH to spend more than $97 million out of that $250 million that is authorized? So take a look at

that, will you, for me?

Dr. KIRSCHSTEIN. We will, Senator.

Senator HARKIN. I think we need to look at that a little bit

longer, closer.

The last thing is—there are a lot of things I would like to get

into. Gleevec, what a great breakthrough on cancer research on

this drug, it seems to me. We have talked about it before, but the

question I have is: How much of NIH’s research went into that,

supported, NIH-supported research went into that?
393

Dr. KLAUSNER. The reality is, that a larger amount of the underlying research that led to understanding the drug target has been

supported by NIH-funded research, starting back in about 1960.

Senator HARKIN. Now, Rick, you know what my next question is.

When I talked about—I was in my home state, and we were talking

about this new drug, and this new candidate, and it looks like it

has maybe applications for other types of cancers, too——

Dr. KLAUSNER. It does.

Senator HARKIN [continuing]. But then the news reports carried

the report that it would come in at around $2,000 or $3,000 a

month, to which one person said, ‘‘That is wonderful. I cannot use

it. How are you going to pay for it?’’

So I am just wondering about the pricing of this, and whether

or not there is some recapture, or something like that. We have to

figure this one out, about what we do about the pricing, and if it

is that expensive, how much comes back into NIH to help us out.

I do not know, but I—that is coming down the road. If you want

to respond to that, fine.

Dr. KLAUSNER. We, of course, are not involved in the pricing of

a particular drug.

Senator HARKIN. I understand that. I understand that.

Dr. KLAUSNER. But we really are very concerned about making

sure—that individuals, individuals that need drugs, have access to

those drugs.

Senator HARKIN. Yes. Well, this is something I think we, up

here, are going to have to figure out on what we want to do on

that, but I just wanted to mention it. We have 4 minutes left.

Thank you, Mr. Chairman. Three minutes.

Senator SPECTER. Thank you all very much for coming. I am always reluctant to take the time of this many distinguished scientists who could be back in the laboratory moving ahead. America

is very fortunate to have such an extraordinary organization like

the National Institutes of Health.

You have heard me say on many, many occasions that you are

the crown jewel of the Federal Government. I stopped saying you

are the only jewel of the Federal Government—I have had too

many complaints about that—but we thank you for what you are

doing.

Senator Harkin and I will continue to fight hard to bring you

more resources, and I think you will have the backing of the Congress and the President.

Thank you.

Dr. KIRSCHSTEIN. Thank you, Mr. Chairman.

ADDITIONAL COMMITTEE QUESTIONS

Senator SPECTER. Thank you very much. There will be some additional questions which will be submitted for your response in the

record.

[The following questions were not asked at the hearing, but were

submitted to the Department for response subsequent to the hearing:]
394

QUESTIONS SUBMITTED BY SENATOR ARLEN SPECTER

NDRI EXPANSION

Question. What have you done to expand NIH support for NDRI?

Answer. Approximately two-thirds of the National Disease Research Interchange

(NDRI) enterprise activity is supported by private foundations and fees charged to

for-profit corporations. The remaining one-third of the activity is supported by an

NCRR/NIH cooperative agreement, now in its tenth year. The National Center for

Research Resources (NCRR) provided sole support during the first eight years of the

grant. Currently, four additional NIH components (the National Eye Institute (NEI),

the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Office of

Rare Diseases (ORD), also provide co-funding for the grant.

Question. More specifically, have you met with each Institute Director and encouraged them to work with NDRI to access its human tissue resources to meet the special needs and initiatives of each Institute?

Answer. A memorandum was sent to the directors of the various Institutes in July

of 1999, inviting them to participate with NCRR in support of this endeavor. The

scope of the NDRI service to the biomedical research community has been reviewed

by a committee of experts and NCRR’s National Advisory Council. The level of support provided for NDRI reflects the recommendations of the peer review process.

The total level of NDRI funding would be the same whether NCRR alone or NCRR

along with several other NIH components supported the NDRI award.

Question. If not, why not?

Answer. The NDRI user (investigator) list and the NIH institutes or Centers relevant to the research areas were systematically reviewed. As a result of that analysis, four additional NIH components were invited to cofund the NDRI application

and all four agreed to participate. The other NIH components supported only a very

small percent of the user activity.

Question. If so, please report what next steps have been taken by each Institute

Director.

Answer. As noted above, the NEI, the NIAID, the NIDDK, and the ORD have

joined NCRR in cofunding the cooperative agreement entitled ‘‘Human Tissue and

Organ Research Resource (HTOR).’’

Question. When will you begin providing NDRI with supplementary funding

through the Multi-Institute Initiative?

Answer. Cofunding by the above-mentioned Institutes and Centers is currently in

place. As noted above, the total level of funding for the NDRI application is independent of the number of NIH components which cofund the application. The peer

review process provides recommendations to NIH staff as to the scientifically and

technically meritorious aspects of the NDRI application and the applicant provides

estimated costs for those costs. These same principles hold for the peer review and

subsequent funding of other meritorious research or resource grant applications.

Question. How much direct supplementary funding will NIH provide NDRI through

the Multi-Institute Initiative beginning July 1, 2001?

Answer. The Notice of Grant Award will be augmented by $300,000 from NIAID

in support of the second year of the demonstration pilot project to obtain HIV positive tissues. The increased level of support reflects additional NDRI activity related

solely to NIAID.

Question. What is your plan to secure supplementary Multi-Institute Initiative

funding for NDRI beyond June 30, 2003?

Answer. A memorandum will be sent again to the Institute Directors inviting

them to support the Human Tissue and Organ Research Resource (HTOR) cooperative agreement.

NINDS STROKE STRATEGIC PLAN

Question. Dr. Penn, I am concerned that stroke remains a leading cause of permanent disability and the third largest killer of men and women in the United States.

Last year this Committee encouraged the National Institute of Neurological Disorders and Stroke, as part of your strategic planning, to work with the research

community, clinicians, voluntary health organizations, and patient advocacy groups

to discuss new avenues of basic and clinical stroke research opportunities. Please

provide us with an update on this activity.

Answer. Stroke research is a high priority of NINDS because this neurological disorder is the most common cause of disability, and the opportunities for progress in

both prevention and treatment of stroke are very great. The Institute’s overall strategic plan, Neuroscience at the New Millennium, addresses research questions of
395

importance to stroke in its discussion of neural environment, experimental therapeutics, funding of research in this area and clinical trials. Evidence of the importance of stroke to our Institute’s efforts, funding of research in this area is supported in both ‘‘Clinical Trials’’ and ‘‘Neural Environment’’ extramural program

groups.

TRANS-AGENCY CONFERENCE ON HEART DISEASE AND STROKE

Question. Dr. Lenfant, several years ago this Subcommittee encouraged the National Heart, Lung, and Blood Institute to hold a trans-agency conference on heart

disease and stroke to obtain an assessment of progress and opportunities and develop a comprehensive research and prevention agenda on heart disease and stroke

for the 21st Century. I have heard that the report on this conference was released

in December of 2000. What was the conclusion in the report and how do you plan

to implement the findings?

Answer. The report of this conference was published in the December 19/26, 2000

issue of the journal Circulation. Among the conclusions were that, for the United

States as a whole, the coronary heart disease (CHD) death rate is still declining,

but more slowly than it did between 1970 and 1990; stroke mortality rates have declined little since 1990; striking differences exist in levels and trends of cardiovascular disease (CVD) by race/ethnicity, socioeconomic status, and geography (for

example, rates of CHD death have declined more slowly among black men than

among white men); and trends in levels of risk factors are consistent with the slowing in the decline in the death rate (little change since 1990 in smoking prevalence,

physical inactivity, and hypertension control and striking increases in prevalence of

obesity and type 2 diabetes). The conference also concluded that although there is

considerable activity in prevention and treatment of CVD, much more needs to be

done with respect to assessing risk factors and applying proven approaches to treat

them. A number of recommendations were made with respect to application of current knowledge and further research.

Concerned about data presented at the conference that some Americans are not

enjoying the improvements in health that can be realized by applying existing clinical guidelines and other medical information, the NHLBI recently developed and

implemented several new programs. One, an education initiative, entails Enhanced

Dissemination and Utilization Centers (EDUCs) in communities with heart disease

and stroke death rates that far exceed the national average. These centers will become the foundation of a network of Healthy People 2010 performance partners

committed to eliminating of racial/ethnic and geographic health disparities in underserved high-risk populations. Funded centers are using information generated by

the national education programs of the NHLBI to inform their communities of the

public heath burden of CVD and are developing, implementing, and evaluating educational strategies to reduce the burden through changes in behavior of health care

providers, patients, and the general public related to the prevention and control of

CVD. The six current centers are located in Arkansas, North Carolina, Virginia,

West Virginia (two), and Texas. One of the EDUCs, West Virginia Health Right,

Inc., in Charleston, is a free primary care clinic that serves the uninsured and

under-insured poor. At the North Carolina EDUC, Wake Forest University School

of Medicine will collaborate with the Robeson County Partnership for Community

Health, Columbus County Hospital, and Columbus County Healthy Carolinians to

reach low-income blacks and Native Americans with CVD screening and cardiovascular health education activities. The University of North Texas Salud para su

Corazo ́n Outreach Initiative EDUC is a collaboration among the University, the

Dallas Concilio, Northside Clinic, Hispanic Health Coalition of Fort Worth, and Harris Methodist Hospital to use lay health educators to reach Hispanics with cardiovascular health promotion and disease prevention activities.

EDUCs are one element of a larger heart-health agenda that the NHLBI launched

as part of its efforts to meet the cardiovascular health goals and objectives in the

federal government’s Healthy People 2010 Report. On February 1, the NHLBI, several other federal health agencies, and the American Heart Association (AHA)

signed a Memorandum of Understanding (MOU) to speed progress toward heart disease and stroke goals set forth in Healthy People 2010. This historic MOU has created a working partnership that promises to improve greatly the nation’s cardiovascular health by the year 2010. The federal agencies and the AHA will work to

accomplish four cooperative knowledge application goals for heart disease and

stroke: prevent the development of risk factors; detect and treat risk factors; achieve

early identification and treatment, especially in the acute phases of disease; and

prevent recurrence and complications. The NHLBI also sponsored a workshop in

March as the first step in developing an ambitious agenda for a new women’s heart
396

health education effort. It brought together a group of about 60 key researchers,

public health leaders, women’s and minority health advocates, health communicators, health care delivery experts, patients, and others who have a stake in improving women’s cardiovascular health to develop a science-based blueprint for a comprehensive health education effort for patients, health professionals, and the public.

Late this summer an award will be made for program support to launch the nationwide education effort. In addition, the NHLBI is continuing to collaborate with the

National Recreation and Park Association to develop and implement a nationwide,

community-based program to reduce the growing trend of obesity and the risk of

CHD in the U.S. by encouraging Americans of all ages to aim for a healthy weight,

follow a heart-healthy eating plan, and engage in regular physical activity. The program targets high-risk and underserved neighborhoods through community park

and recreation programs.

The NHLBI will continue its ongoing projects in African American and Latino

communities and is now taking steps to implement strategies to improve the health

behavior of several underserved Asian American/Pacific Islander (AAPI) groups, including those of Philippine, Vietnamese, Native Hawaiian, Samoan, Cambodian,

Hmong, and Laotian heritage. To begin formulating culturally and linguistically

sensitive heart health education materials for these AAPI ethnic groups, consumer

interviews and discussions with community leaders are being conducted and efforts

to build community-based networks in these underserved AAPI communities have

begun. So far, 15 community-based network partners across the country have been

enlisted to assist in the implementation of outreach activities in underserved AAPI

communities. The NHLBI is also beginning the second phase of its three CVD

projects in American Indian and Alaska Native (AI/AN) communities to develop and

implement community-based interventions to increase awareness and to expand

adoption of heart-healthy behaviors and thereby reduce health disparities. The three

communities are the (1) Ponca Tribe of Oklahoma with about 2,500 members, (2)

Bristol Bay Area Corporation with 32 villages in Southwestern Alaska, and (3) Laguna Pueblo in New Mexico with about 4,000 members. The NHLBI has joined

forces with the Indian Health Service to use the tools and materials developed during the first phase of the project to implement community-based outreach and education activities in the three communities over the next 3 years.

To continue the dialogue regarding the issues and recommendations put forth at

the CVD Trends Conference, the NHLBI is sponsoring a National Cardiovascular

Health Conference, ‘‘Cardiovascular Health for All-Meeting the Challenge of

Healthy People 2010,’’ to be held in April, 2002 in Washington, D.C. We expect an

onsite attendance of 2,000 health professionals committed to eliminating the racial/

ethnic, gender, and geographic disparities reported at the CVD Trends Conference.

Conference cosponsors include the AHA, the CDC, HCFA, and HRSA. The Institute

has also developed an innovative NHLBI Healthy People 2010 Gateway Web site

and integrated Health Information Network (HIN) at http://hin.nhlbi.nih.gov. Visitors to the Gateway are offered quick access to a wide range of resources that can

be used for planning and implementing community-based Healthy People (HP) 2010

activities. The current NHLBI HP 2010 performance projects are defined, and ongoing activities and progress of performance teams are reported through a variety of

means including Webcasts of major meetings, electronic communication memos, and

special Web pages that provide details about performance partners, major project

events, pilot project results, and access to the latest NHLBI-developed resources.

Visitors are encouraged to complete an electronic application to become a HIN partner. Partners receive electronic notifications of new NHLBI educational products

and services, late-breaking news of NHLBI-funded research findings, notification of

NHLBI conference Webcasts, distance learning opportunities, and special Web-based

applications such as interactive disease mortality maps to assess the magnitude of

the public health burden of disease by state and Health Service Area. Network

membership has been increasing on a daily basis-it currently numbers over 11,000

health care providers, public health practitioners, patients, and other interested consumers nationwide as well as a growing international representation.

The Institute is also funding a program of grants to evaluate interventions in clinical care settings that are designed to improve adherence to medically prescribed

lifestyle changes used to treat heart disease. This program targets racial and ethnic

minorities and/or persons living in poverty. In addition, the NHLBI is initiating an

evaluation of innovative strategies that can be used in clinical practice to improve

implementation of evidence-based guidelines for treatment of heart disease.
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NEW CHOLESTEROL GUIDELINES

Question. Dr. Lenfant, I am a staunch proponent of prevention. Cholesterol is a

major risk factor for heart disease, the leading cause of death of Americans, and

for stroke, the No. 3 killer in the United States. The National Heart, Lung, and

Blood Institute’s new cholesterol guidelines have received a lot of attention. These

guidelines are the first major revision in about 10 years. Please explain to this Committee how these guidelines have changed from the ones published nearly a decade

ago and how well can you insure that these new cholesterol guidelines are implemented.

Answer. The new cholesterol guidelines developed by the Institute’s National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) are evidence-based. The ATP III report states explicitly the nature and strength of the evidence, derived from a rigorous and systematic review, that forms the basis for its

conclusions and recommendations. Compared with the previous guidelines, which

were released in 1993, the ATP III guidelines have several new features. First, they

call for more aggressive lowering of LDL (bad) cholesterol, the primary target of

therapy, in individuals at high risk for a heart attack or death from coronary heart

disease (CHD). This high-risk group includes those who have CHD itself, diabetes,

or multiple (2 or more) CHD risk factors and a 10-year risk for CHD greater than

20 percent. These high-risk people have the most stringent LDL goal: <100 mg/dL.

Individuals with multiple risk factors and a 10-year CHD risk of 10–20 percent are

also at substantially elevated risk and often require aggressive therapy, but their

LDL goal is somewhat less stringent: <130 mg/dL. The ATP III report provides a

risk assessment tool to identify individuals who require intensive cholesterol-lowering treatment; based on data from the NHLBI Framingham Heart Study, it enables calculation of 10-year CHD risk. A second new feature is a more intensive set

of Therapeutic Lifestyle Changes (TLC) that constitute the mainstay of cholesterollowering therapy and offer greater potential to lower LDL than the previous guidelines. Third, the new guidelines define and recommend treatment for a cluster of

CHD risk factors known as ‘‘the metabolic syndrome,’’ which is related to the increasing prevalence of obesity and overweight in the United States. Fourth, the ATP

III report urges greater clinical attention to high triglycerides and low HDL (good)

cholesterol, both of which are linked to increased risk for CHD. Fifth, the guidelines

recommend a complete lipoprotein profile (total, LDL, and HDL cholesterol and

triglycerides) as the preferred initial test for detecting cholesterol problems. Sixth,

ATP III sets a new level at which low HDL becomes a major CHD risk factor (<40

mg/dL, as compared with <35 mg/dL in ATP II). Seventh, ATP III recommends ways

of improving professional and patient adherence to the guidelines and to appropriate

therapy.

The new guidelines identify many people who are at higher risk for CHD than

had previously been recognized and, thus, their application will increase the number

of people who need cholesterol-lowering lifestyle therapy from about 52 million to

about 65 million. Of these, about 36 million will need to combine drug treatment

with lifestyle changes to achieve an adequate reduction in CHD risk; the vast majority (80 percent) of them are in the two highest categories of CHD risk.

The results of cholesterol-lowering clinical trials suggest that full implementation

of ATP III guidelines could produce approximately a 30 percent reduction in the rate

of CHD, which continues to be the leading cause of death of women and men in this

country and currently accounts for almost 500,000 deaths annually. To help ensure

implementation of the ATP III guidelines, the NCEP has developed an array of new

products and tools. For professionals, the aids include an Executive Summary of the

evidence and recommendations that was published in the Journal of the American

Medical Association (JAMA) together with a patient page on cholesterol and an editorial from the JAMA editors urging physicians to implement the guidelines. Other

tools include a PowerPoint slide show for teaching the guidelines to professional audiences; an ATP III At-A-Glance Desk Reference that outlines the basic action steps

in management of LDL, HDL, and triglycerides; a Palm OS interactive tool that

puts the guidelines at the fingertips of physicians for use at the point of care; and

a 10-year CHD risk calculator in online and downloadable (Excel spreadsheet)

versions. To empower patients to be active partners in their care, the NCEP has

developed a new patient brochure entitled ‘‘High Blood Cholesterol—What You Need

to Know,’’ a 10-year CHD risk calculator for lay audiences, and an updated Web site

(‘‘Live Healthier, Live Longer’’) that reflects the new information in the ATP III report. All of these tools are available on the ATP III Web page, which can be accessed

by going to the NHLBI Web site (www.nhlbi.nih.gov). In addition to developing and

distributing these new products the NHLBI, through the NCEP, has established a

strategic partnership with the National Committee for Quality Assurance (NCQA)
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1 National Vital Statistics Reports, Vol. 48, No. 11, July 24, 2000. Table 7.

to promote adoption of the new guidelines. The NCQA and the NHLBI cosponsored

a national conference for professionals on ATP III implementation June 3–5, 2001.

The HEDIS (Health-plan Employer Data and Information Set) performance measures of the NCQA can help ensure implementation of ATP III, and NCQA involvement will extend the reach of the new recommendations into managed care. By

these various means, the NHLBI and the NCEP are seeking to speed adoption of

the ATP III guidelines.

RETURN ON INVESTMENTS

Question. As you know I believe that NIH is the crown jewel of the federal government and an institution that deserves our highest priority. I am always concerned,

however, about the returns we see from our investment.

I realize that establishing deadlines in science such as predicting when a certain

disease will have a cure is difficult to do, however, how do you propose that we

measure the return we are getting from our investment in NIH?

Answer. As required by the Departments of Labor, Health and Human Services,

and Education, and Related Agencies Appropriations Act, 2001, the NIH will be addressing the issue of return on NIH investments by submitting a report by July

2001 that includes a listing of therapeutic drugs which are FDA approved, have

reached $500 million per year in U.S. sales, and have received NIH funding.

POPULATION MORBIDITY AND MORTALITY RATES

Question. Do we see an improvement in morbidity and mortality rates as a result

of government funded research?

Answer. It is difficult to attribute the exact share of improvements in population

morbidity and mortality rates that is due to government funded research. Historically, we know that health and longevity are influenced by increases in income, education, public sanitation and access to care. Of course NIH does not control access

to care or participate directly in the delivery to care. However, there is much evidence from clinical trials that new research-based technologies can reduce mortality

and morbidity rates when applied appropriately. And recent declines in population

morbidity and mortality rates for specific conditions and disorders can be attributed,

at least partially, to research-based diagnostic screens, vaccines and other

preventives and therapies.

The age-adjusted death rate for all causes fell from 577.0 per 100,000 in 1979 to

471.7 in 1998 (Use of the age-adjusted rate adjusts for increases in deaths due to

growth and aging of the population).1 The corresponding rate for Diseases of the

Heart, the leading cause of death, fell from 199.5, to 126.6. over the same period.

The recent data on age-adjusted decline in heart attacks and deaths due to heart

disease is based on years of research to identify and refine our ability to control risk

factors for heart disease such as hypertension and high blood cholesterol levels. Research confirmed the effectiveness of diet and exercise in controlling risk factors and

conditions such as high cholesterol levels, hypertension, obesity and diabetes. Preliminary, unpublished analysis suggests that the majority of the reduction in the

Cardiovascular Disease mortality rate from 1950 to 1990 may be attributable to providing this information to the public. Information about risk of hypertension, smoking, and high cholesterol levels was made available and diffused widely to individuals and to physicians throughout the country. In response, people modified their

diets and exercise patterns, and physicians changed their testing protocols and medical advice, according to a Harvard University study.

The use of the common aspirin, to reduce the risk of heart attack and as part of

the immediate post heart-attack treatment, is another example of an application of

research which, at small expense, reduces health care costs.

Another example comes from research on the prevention of stroke patients who

suffer from atrial fibrillation. The two million Americans who have atrial fibrillation

are six times more likely to have a stroke than people who do not, and this accounts

for as many as 80,000 strokes a year. A decade long study, by NINDS, carefully examined the best strategy for balancing prevention of strokes versus the risk of adverse side effects among such individuals. Aspirin was recommended for patients

with atrial fibrillation in the low risk category and warfarin for those with more risk

factors for a stroke. This is another significant example of careful research to provide a tailored, low-tech strategy to prevent a high cost disease.

Another example of a low-tech alternative therapy was provided when research,

supported by NIDDK, confirmed the efficacy of a new therapy for peptic ulcers using

already available pharmaceuticals. Treatment of the cause of these ulcers, a bac-
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2MMWR. ‘‘HIV and AIDS in the United States’’ June 1, 2001/Vol. 50/No. 21. Figure 1, page

432.

terium (Helicobacter Pylori), using a ‘‘triple therapy’’ of available drugs—tetracycline, metronidazole, and bismuth subsalicylate (Pepto-Bismol)—speeds the cure

and cuts the recurrence rate of ulcers. Research found the recurrence rate for peptic

ulcer fell to the 12 percent to 13 percent range, compared to the 74 percent to 95

percent recurrence rate with the previous conventional treatment using antacid

preparations and surgery. The resulting annual savings in treatment costs are estimated in the hundreds of millions of dollars. Cataract surgery is another example

of an intervention which extends working life and enhances functioning and independence of the retired. Intervention to restore sight is essential for human wellbeing. What once required a long hospital stay including days in intensive care, is

now performed on an outpatient basis. Meanwhile, the National Eye Institute continues to support research aimed at understanding and preventing cataracts, as well

as other vision disorders.

Another evidence of advance is the reduction in infant deaths from all causes from

just less than 5 per 100 live births in 1940 to less than one per 100 today. The

causes are multiple, but many are research based. Infant mortality rates from congenital cardiovascular malformations, for example, have declined as a result of rapid

advances in the field of infant heart surgery. Several research projects have contributed to improved evaluation and treatment guidelines, the development of 3-D imaging techniques, echocardiography, and deep hyperthermia surgical technique.

HIV/AIDS remains a national and international epidemic, but there has been research based progress in this area as well. In the U.S. the incidence rate of new

cases dropped for the first time in 1993 and deaths among people with AIDS declined for the first time in 1996, dropping 25 percent.2 As a result of new, more effective combination therapies, people are living longer with HIV and development

of opportunistic infections are being delayed.

These are but a few examples of where medical research has improved health and

reduced morbidity and mortality.

NEW TECHNOLOGIES IN NIBIB

Question. I note that you are requesting $40.2 million for a new National Institute

of Biomedical Imaging and Bioengineering for creating new technologies. Is there

any thought given by yourself or your staff about the cost-effectiveness of these new

technologies?

Answer. We are excited about the new opportunities that the new National Institute of Biomedical Imaging and Bioengineering (NIBIB) will create for support of

fundamental research that applies principles of engineering, mathematics, computer

science and the physical sciences to biological processes, disorders and diseases.

NIBIB has great potential to promote innovation and discovery that could have a

significant impact on virtually every area of medical science. We have just begun

to constitute our research portfolio and identify programmatic gaps and prioritize

the many scientific opportunities before us. As the application of these scientific disciplines to medicine is still relatively new, it would be premature to make ironclad

promises as to their cost-effectiveness. However, we plan to conduct technology assessment and outcome studies as authorized by legislation. As the science and the

NIBIB research portfolio mature, we will plan to conduct such evaluations to answer the question you propose.

Question. Are we at risk of developing technology that is unaffordable to many

people as we are seeing with some of the AIDS antiviral drugs?

Answer. NIBIB will support fundamental research that applies principles of engineering, mathematics, computer science and the physical sciences to biological processes, disorders and diseases. In some respects, such an approach to human health

is still relatively new. We will support studies that examine incremental changes

from technologies as they are applied today, as well as new and innovative approaches that reject current technologies in favor of completely new paradigms. The

studies that NIBIB will support will add to biomedicine’s knowledge base. At this

juncture, there is no way to tell which as yet undeveloped technologies may make

the largest impact on health and what the cost of these technologies would be.

NIBIB’s is authorized to conduct technology assessments and outcome studies, and

such evaluations will address these key issues.

RESEARCH PROJECT GRANTS

Question. I also note that the funding rate for grant applications has remained

at around 1 in 3. Are the remaining two-thirds of significant less quality?
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Answer. Success rates for Research Project Grants (RPGs) represent a complex set

of factors. They represent the ratio of RPG awards to the total RPG applications

received for that fiscal year. Success rates vary among Institutes, among RPG activities such as single-investigator initiated traditional (R01s) grants and multiple

investigator program projects (P01). Success rates and submission of applications

also vary among types of grants, such as new grants, first time awardees, and competing renewals which depend on the cycling of grants from noncompeting to competing status. Furthermore, there is not a linear relationship between budget level,

number of applications, and number of awards. That is, an increase of twice the current budget levels will not result in an increase in twice the number of applications

or twice the number of grants awarded. This is because institute portfolios are

based on a number of interrelated mechanisms and factors, including the balance

between intramural and extramural research, investigator initiated projects, contracts, centers, as well as the number of grant applications, the size of grants, the

length of project periods.

With the recent increases in the NIH budget, we have funded research project

grants that typically have larger budgets, such as clinical trials, epidemiologic studies and various genomic projects. We have also witnessed an increase in the number

of applications, but not to the extent that has significantly affected our success.

There are always some projects that would ordinarily remain unfunded, but which

have some particular value and for which we might make a modest award. However, our experience is that those applications that are in the lower half of all applications received are generally in need of significant revision before we would consider funding.

MERITORIOUS RESEARCH

Question. Are we shutting out the majority of meritorious research with our current budget?

Answer. No, we are not shutting out the majority of meritorious research with the

current NIH budget. While peer review remains a highly competitive process, the

NIH is firmly committed to funding meritorious research. The Institutes and Centers (ICs) have developed various strategies to fund applications that are of particular significance or importance to public health, e.g., through selective pay or

bridge grants. In some cases it may be desirable to fund a portion of an application

or provide seed money to help an applicant develop a fuller research plan for resubmission and review at a later date.

CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS

Question. Are the programs in place at the NIH to attract clinical researchers sufficient?

Answer. The NIH launched three new clinical research career development programs in fiscal year 1999—Clinical Research Curriculum Award (K30), Mentored

Patient-Oriented Career Development Award (K23) and Mid-Career Investigator in

Patient-Oriented Research Award (K24). These programs have been successful and

continue to attract enthusiastic response from the community. Since their inception,

NIH has funded 278 K23, 158 K24, and 55 K30 awards.

In addition to these programs, the NIH is currently developing a program announcement to provide support to institutions to develop degree-granting programs

in clinical research. It is anticipated that the National Center for Research Resources will take the lead in this initiative and launch it in fiscal year 2002. We

believe that these new programs, along with the other existing clinical career development awards, e.g., K08, K12, etc, have gone a long way in addressing the need

for training more qualified physician scientists.

Question. Are you seeing an adequate number of clinical research grant applications in comparison to basic science?

Answer. In fiscal year 2000, the NIH funded over 11, 000 clinical research awards

out of a total of 44,363 awards (26 percent), both new and continuing projects. This

number of awards includes all types of NIH-supported extramural awards, including

training grants, fellowship awards, construction grants, NLM resource awards, and

research and development contracts. The percentage of clinical research awards has

remained relatively stable for the last five years.

STEM CELL

Question. I asked for detailed responses from each of your institute directors on

the role of stem cells in the mission of their respective institute. Most of these reports give overwhelming support to the potential of stem cells in their field. I also
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understand that you have only received 3 applications for stem cell grants this year.

Is this surprising to you?

Answer. Still in review. Will provide an answer upon completion.

CANAVAN’S RESEARCH

Question. Please explain to the Committee what research is currently being conducted at the NIH on Canavan’s Disease.

Answer. Canavan’s disease is one of a very large number of childhood brain diseases, each caused by inherited defects in a different enzyme. In this case, the enzyme affected is called aspartoacylase and the disease is very severe. About a decade ago, scientists identified the enzyme that was at fault. About five or six years

ago, the gene causing the defect was identified. Just last year, an NIH-funded scientist succeeded in creating a genetically engineered mouse model of Canavan’s disease. The mouse model of the disease will enable researchers to study precisely how

the gene defect harm the brain and to develop and test possible therapies. More

generally, NIH supports considerable efforts to develop therapeutic interventions for

the many inherited enzyme disorders, such as Canavan’s, for which the gene is now

known, but no therapy is available. These potential interventions include conventional drugs, gene therapy, use of stem cells, and enzyme replacement. NIH is encouraging more research concerning these diseases through workshops, solicitations

and other efforts.

A recent report indicated that an application that was pending before the NINDS

was not funded because of the lack of a control group.

Question. Please provide a detailed description of the problems involved in funding a safety trial for persons with Canavan’s Disease.

Answer. As you have noted, an application to study the transfer of the

aspartoacylase gene to children with Canavan’s disease is pending. As you can well

imagine, the issues and considerations involved in the design of a clinical trial to

establish the safety of a gene-based intervention for children with Canavan’s disease

are extensive. Such a study involves not only gene transfer, but gene transfer to the

brain by neurosurgical procedures in children. First, the grant application must ensure that the preclinical and preliminary clinical data are of sufficient strength to

support proposing such a trial in children. Then, the study design presented must

thoroughly address numerous safety and ethical issues including concerns about the

establishment of outcome measures; the use of anesthesia during diagnostic MRIs

and surgery; safety controls in production of the vector, that is, the agent being used

to transfer the genetic material; potential immune responses to the vector; safety

of administration of the vector including the number and location of injection sites

in the brain and the rate of administration; the risks of the neurosurgery itself; the

plans for post-operative care; the adequacy of the informed consent process; the procedures established for the monitoring and reporting of adverse events; and the

overall plan for data and safety monitoring. In addition, the NINDS must ensure

that all required reviews and approvals for a trial of this nature have been received.

These would include not only approval of the investigational new drug (IND) application by the Food and Drug Administration, but protocol submission to the NIH

Recombinant DNA Advisory Committee (RAC), and approvals of the research protocol, including the informed consent and safety monitoring processes, by the local

institutional review boards (IRBs).

I can assure you that members of the NINDS staff have been working closely and

intensely with the principal investigator of the proposed study to which you refer,

so that the pending application can be given every consideration in accordance with

applicable policies and procedures. The Institute is committed to advancing research

on Canavan’s disease as well as the other childhood brain diseases caused by enzyme deficiencies that result from inherited genetic defects.

QUESTIONS SUBMITTED BY SENATOR TED STEVENS

VARIANT vCJD THREAT

Question. As you may be aware, Senate Subcommittee on Consumer Affairs, Foreign Commerce and Tourism held a hearing on April 4 of this year on transmissible

spongiform encephalopathies, also known as TSEs. One type of this TSE called variant Creutzfeldt-Jakob Disease (vCJD), has been a particular problem for our friends

in Britain where 97 people have died from vCJD, presumably from the consumption

of prion infected beef. In your opinion is vCJD a threat to the United States?

Answer. We should keep proper perspective since there has not been a case of the

human disease, vCJD, in the United States, but we must remain vigilant to ensure
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that we take the proper steps to make sure that vCJD does not affect people in this

country. There is strong evidence that the distinctive biological and molecular features of the infectious agent isolated from cattle infected with BSE, or mad cow disease, are identical to that in the human cases of vCJD, so that prevention of the

animal disease, BSE, is important for prevention of the human disease, vCJD. BSE

has not been detected in the U.S., but it would be unwise to assume that it can’t

happen here. We still don’t know for sure how BSE first arose in Britain-it might

have been from ‘‘rendered’’ cattle feed containing remnants from sheep with the related disease scrapie, or perhaps BSE arose spontaneously as the form of CJD in

humans can do. We do have sheep with scrapie in this country, as well as other

animals such as deer with a closely related disorder, chronic wasting disease (CWD).

Furthermore, most cattle are slaughtered at an age too young to show obvious

symptoms of BSE or to be detected as infected on currently available tests, so a

spontaneous case capable of harboring and transmitting the disease could go undetected. So, the important thing is that we must make sure that we have procedures

in place to prevent an isolated case of BSE from spreading if it does occur.

As discussed at the hearing you noted, the U.S. Department of Agriculture, the

Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention CDC) have imposed a series of safeguards to protect human and animal

health. In Britain, it was later learned that the spread of BSE was greatly increased

because carcasses of BSE-infected cattle were used to make animal feed (meat and

bone meal), resulting in contaminated product that was fed to other cattle. The FDA

in 1997 published a regulation to prevent this type of spread of BSE, should BSE

occur in this country. The FDA regulation prohibits the use of most mammalian protein to make feed for cattle or other ruminant animals. We should also keep brains

and spinal cords, which are most likely to carry the disease, out of the human food

chain.

We must continue to examine whether our practices are adequate and update

these measures as new evidence or better scientific understanding dictates. Congress has charged the General Accounting Office to do just that, and we have

briefed the GAO on TSE science and research. NIH has played an important role

since the 1950’s in laying the scientific foundation for confronting the public health

and economic threats from the group of diseases that includes CJD and BSE. In the

past year, we have increased our efforts, especially those towards developing practical tests for early detection that are badly needed. We will continue to work with

other agencies to make sure vCJD does not become a problem in the United States.

vCJD ON THE RISE?

Question. Have we seen the worst of this disease yet?

Answer. The unsettling truth is that we just don’t know. The British are monitoring the incidence of vCJD closely. This class of diseases has an incubation time

that can be as long as decades, so it is too early to tell. The numbers of vCJD cases

in Britain each year from 1995 through 2000 have been 3, 10, 10, 18, 15, and 27.

Three additional cases have occurred in France and one in Ireland. Great Britain,

France, and Ireland all have BSE among cattle, unlike the United States. The small

numbers don’t allow any reliable prediction of a trend, so we don’t know whether

2001 will show the incidence is still on the rise, leveling off, or starting to decline.

In this country, the CDC monitors cases of classical CJD and conducts disease surveillance to detect the possible ocurrence of vCJD. So far, no cases of vCJD have

been detected in this country.

ROLE OF NIH IN vCJD RESEARCH

Question. What do you perceive the role of the NIH to be in researching and finding a cure for a disease such as vCJD that has yet to infect a single American?

Answer. Although variant of Creutzfeldt-Jacob disease (vCJD) has not affected a

single American, the conventional form of CJD kills about 250 to 300 Americans

each year. We should not forget that if BSE were to occur in the United States, it

could potentially devastate the cattle industry as it did in Britain. This would have

major economic consequences. We are also quite concerned about the prevalence of

related diseases such as the spontaneously occurring chronic wasting disease (CWD)

in deer and elk in the United States.

NIH has supported pioneering research on CJD and other TSEs since the 1950’s.

This research that has been recognized by the award, to U.S. scientists, of two

Nobel prizes because of its significance to science and medicine. The scientific foundation of the work supported by NINDS has been essential for confronting the public health threat of vCJD with appropriate safeguards and without panic.
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These are unusual diseases. We would not have been able to detect the disease,

how it is transmitted, where to focus our future work, and what precautions to take,

without those years of scientific investigation supported by NINDS before BSE and

vCJD appeared. We are actively engaged in strengthening our broad program of investigation into these disorders, including work towards developing diagnostic tests

and treatments. Last year, we awarded major contracts focused on developing tests

capable of detecting early stages of the disease, tests that at this point, are critical

to confront the public health and economic threats.

Finally, rare diseases often show us the way toward understanding common diseases, and there are some intriguing suggestions this may be so in this case, too.

Many scientists, including the Nobel winners I noted, believe that the study of CJD

may offer clues to more common neurodegenerative disorders such as Alzheimer’s

and Parkinson’s.

VIRAL SIMILARITIES

Question. Do you see any similarities between vCJD and the West Nile Virus or

the AIDS virus?

Answer. The most significant feature shared by all three of these viruses is that

they all originated as an infection of a non-human species and humans were, or still

are, the ‘‘accidental’’ hosts. Infections such as these are known as ‘‘zoonosis.’’ The

origin of variant Creutzfeld Jacob Disease (vCJD) is thought to be bovine

spongiform encephalopathy (BSE) or mad cow disease. The mechanism of transmission to man is still not understood. Ironically, cows may also be an ‘‘accidental’’

host probably acquiring the infection from sheep infected with scrapie, another related disease.

West Nile Virus (WNV) is only spread to humans by the bite of a female mosquito, usually Culex pipiens. Humans are considered to be ‘‘accidental hosts’’ in a

cycle of transmission of WNV, that is normally from mosquito to bird and then back

to mosquito, when it feeds on infected birds. Unfortunately, infected mosquitoes can

also spread disease to man, horses, cats and dogs.

Although HIV is now most commonly spread by sexual transmission or contact

with blood from another infected human, the origin of HIV was likely the accidental

transmission to humans of a related non-human primate virus.

While the HIV virus, vCJD, and WNV also share certain biological properties

such as the ability to affect the brain, they are caused by different agents, take different paths to infect man, produce different symptoms, and differ in other important ways. The agent that causes vCJD is believed to be a ‘‘prion’’, agent containing

protein only and without a genome. Its pathology results from a chain reaction

when the prion initiates a series of repetitive improper folding of a normal brain

protein. Classic CJD is a ‘‘slow’’ disease that may take many years between exposure and disease and the course of the disease itself is slow, in the range of four

to five years. One of the frightening features of the new variant vCJD is that the

course of disease is more rapid, and patients progress from first symptoms to death

in about a year.

The West Nile virus is a flavivirus. This is a family of viruses whose genome is

single-stranded RNA. Unlike vCJD, WNV causes an acute infection in that both the

incubation period and the time of symptomatic infection are short. Most infections

are mild but the severe form of the infection, encephalitis, may occur if the virus

is able to migrate from the blood to the brain.

The genome of HIV is also RNA, but during replication it is transformed to a double-stranded DNA copy which integrates into host cellular DNA. HIV, like vCJD,

causes a chronic infection with disease developing long after initial exposure, although some individuals may have mild flu-like symptoms within a few weeks of

infection.

These three diseases taken together serve as reminder that we must take a global

perspective on research and public health. Each of these diseases has its origin outside of the United States. Vector-borne diseases, such as West Nile Virus infection,

which have a complex life cycle in nature that involves an animal host that amplifies the infection and the mosquitoes that transmit virus, have never respected borders, and the reality of commerce and air travel today accelerates the spread of such

diseases. With modern transportation, a person or other carrier with an infectious

disease can travel to the United States from any part of the world, often during the

incubation period of a disease—that is after infection begins but before any symptoms are apparent. In the future, we will certainly confront other new or ‘‘emergent’’

diseases, like AIDS HIV infection or vCJD, diseases previously unseen or rare in

the United States, like West Nile or Hantavirus, and drug resistant forms of old

diseases, like tuberculosis and malaria. Thus, we must maintain a broad research
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base and a responsive public health infrastructure so we can deal with the unexpected. NIAID has a long-standing commitment to research directed toward understanding, identifying, preventing and controlling emerging and re-emerging infections (for more information see the website, www.niaid.nih.gov/dmid/eid).

vCJD AND PRION INFECTED BEEF

Question. To your knowledge, is the consumption of prion infected beef the only

way for humans to contact vCJD?

Answer. The evidence is quite compelling that vCJD is linked to BSE, or ‘‘mad

cow disease,’’ but we are not certain exactly how people acquired the disorder from

cows. Consumption of beef, especially beef products that contain spinal cord and

brain tissue, is the most likely route. However, the FDA has also been considering

potential risks posed by the use of drugs, dietary supplements, cosmetics, and processed foods derived from cattle. The agent of CJD cannot be destroyed by sterilization. Thus, while CJD cannot be transmitted from human to human by casual contact, it can be transmitted by brain material on contaminated surgical instruments,

or by drugs derived from certain tissues, so this presents another range of possibilities, though probably quite limited if the number of vCJD cases remains low. There

is a theoretical possibility that CJD might be transmissible by blood products, but

there is no evidence that this has ever occurred, despite several ongoing investigations of blood donors, and specifically, of people who received blood or blood products

from donors later diagnosed with CJD, and hemophiliacs, who are exposed to products derived from pooled blood from large numbers of donors. So, in short, there are

other possibilities through which vCJD might be transmitted, but consumption of

products from cattle infected with BSE seems the most likely.

PRION RESEARCH

Question. Are you aware of any other diseases that may be better understood as

a result of research in prion diseases like vCJD?

Answer. Rare disorders often provide clues to more common diseases, and scientists have certainly argued that this is the case for prion diseases. In particular,

prion diseases seem to involve the formation of abnormal aggregates of proteins in

the brain. Abnormal clumps of proteins are also strongly associated with several

more common neurodegenerative diseases, including Alzheimer’s, Parkinson’s, Huntington’s, and the spinocerebellar ataxias. For all of these diseases, scientists are actively studying just how the abnormal processing of proteins leads to aggregates and

how that relates to the progression of the disease. All human brains have a normal

prion protein but we do not know what its function is nor how it becomes abnormal

and possibly can cause disease. We are beginning to learn that, when the normal

prion protein and closely related proteins are not present, brain dysfunction occurs,

and this might be an important clue. At this point, it is too soon to speculate as

to where such research will lead.

NIH SUPPORT OF PRION RESEARCH

Question. If so, does increasing our NIH investment in prion disease make sense

to you?

Answer. We are increasing our investment in this area, especially in critical areas

like the development of diagnostic tests. The Department has been coordinating the

NIH efforts with those in the FDA and CDC. The issues of BSE in cattle and prevention of an vCSD infections in the U.S. are of public health significance and the

need for a useful, reproducible diagnostic test is essential. However, scientists with

specialized training in prion diseases are needed to do productive work in this area.

Much of this research requires very expensive, high level safety containment facilities, and we are working on enhancing that aspect as well. We must also maintain

close communication with the considerable efforts underway in Europe, so we learn

from their experience and work together toward the same ends.

QUESTIONS SUBMITTED BY SENATOR TOM HARKIN

PANCREATIC CANCER

Question. Pancreatic cancer is the fourth leading cause of death from cancer for

men and women, but the amount of research funding per mortality that’s devoted

to it is among the lowest of all cancers. What’s more, the NCI’s Progress Review

Group on Pancreatic Cancer found that there are only about 9 principal investigators in the United States who are focused on this terrible disease. What can be done
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to increase funding for research in pancreatic cancer and to get more scientists involved?

Answer. The NCI is committed to increased resources for pancreatic cancer research. The aim of this increase is to catalyze implementation of the research priorities recommended in the Pancreatic Cancer Progress Review Group (PRG) report.

The NCI has always funded outstanding research, including research focused on

pancreatic cancer. The low level of NCI funding for pancreatic cancer research, and

the limited number of researchers focused on this disease, largely reflects the difficulty in studying it. For example, pancreatic cancer exhibits a diversity of biological properties, and patients exhibit a variety of nonspecific symptoms. In addition,

as noted in the PRG Report, pancreatic cancer care is complicated, and outcomes

are nearly always disappointing. Nevertheless, the NCI is committed to a leadership

role in surmounting these difficulties.

In response to the PRG Report, the NCI is undertaking a comprehensive review

of its initiatives, activities, and funded projects, as they relate to the PRG’s recommendations. In July, the NCI Director and other NCI staff will meet with the

PRG members to identify gaps in the NCI research portfolio and discuss strategies

for filling them. After the conclusion of this meeting, the NCI will prepare a plan

for implementing the PRG’s recommendations. This plan will include strategies for

addressing recommendations that haven’t been addressed adequately. It also will include information about ongoing NCI activities that address the PRG’s other recommendations. The NCI will reconvene a meeting of some or all of the members

of the PRG in 2–3 years to discuss and assess progress in advancing scientific

knowledge and implementing the PRG’s recommendations.

In summary, the NCI will aggressively increase resources for pancreatic cancer

research, and it will address and implement the PRG’s recommendations thoroughly

and comprehensively. Through these efforts, the Institute hopes to increase the

number of researchers focused on pancreatic cancer, and more importantly, to alleviate the burden of pancreatic cancer on U.S. citizens.

Last August, the general counsel for the Department of Health and Human Services said federal funding could be used for research on embryonic stem cells as long

as the cells met certain NIH guidelines. But it’s unclear whether any such cells

exist. The only group that is known to be distributing stem cells in the United

States is WiCell, and their cells do not meet NIH guidelines. There’s an Australian

researcher who says his cells do meet the guidelines, but this claim has not been

verified.

STEM CELL FUNDING

Question. Do you know whether there are any stem cells today that are eligible

for federal funding?

Answer. Still in review. Will provide an answer upon completion.

BIOMEDICAL RESEARCH INFRASTRUCTURE

Question. The president has requested a nearly 30 percent increase in funding for

construction of extramural NIH research facilities, for a total of $97 million. Even

that increase, however, is significantly below what’s needed to address the current

backlog, let alone provide adequate lab space for the influx of new research. A 1998

National Science Foundation study on the status of scientific research facilities at

U.S. college and universities identified an estimated $11.4 billion in deferred construction and renovation projects, as well as a decrease in new construction of

health research facilities across an array of institutions. Has the NIH collected any

data on the extent of this problem?

Answer. In general, the Nation’s research infrastructure has served the biomedical community well to date, allowing the United States to remain a world leader in biomedical science. There is some data that suggests that the Nation’s biomedical research infrastructure is fast becoming outdated or insufficient, for example the NSF report. NIH has not collected any data itself on the extent of the problem.

The need for modern research facilities will become increasingly urgent in the

coming years. As research becomes more complex, which in turn, requires a multidisciplinary research team with complementary scientific expertise there are even

greater demands on the nation’s already overburdened research facilities. In addition, entirely new types of research facilities are needed to keep pace with today’s

rapid rate of change in the biomedical sciences and the need to accommodate high

through-put technologies. Many emerging disciplines and technologies require new

types of specialized facilities, such as biocontainment laboratories for handling infectious agents or clean rooms for producing clinical-grade gene vectors. As a result,
406

facilities once expected to last for two or three decades can become technologically

obsolete in less than half that time.

The Acting Director of NIH, Dr. Ruth Kirschstein, appointed a Working Group of

the Advisory Committee to the Director, NIH, to identify some of the factors that

limit the construction and renovation of biomedical research facilities. The Working

Group’s primary charge was two-fold: (1) To examine the adequacy of current funding mechanisms for enhancing the infrastructure of research facilities in the biomedical sciences, and (2) To propose Federal actions that might bolster needed construction and renovation of such facilities at a variety of institutions. The Report

of the Working Group was presented at the meeting of the Advisory Committee to

the Director at the meeting this June. Dr. Kirschstein requested that the members

of the ACD further discuss the recommendations in the Report with colleagues at

their institutions; the report may be modified as a result of that process before the

ACD accepts the Report. Question. Extramural NIH construction is authorized at

$250 million. Given the current situation, would it make sense for the NIH to spend

more than $97 million?

Answer. The fiscal year 2002 Budget provides $100 million for extramural construction, a $22 million increase (∂28 percent) over fiscal year 2001. This funding

level will enable the NIH to continue to support infrastructure upgrades at biomedical research facilities through the Research Facilities Construction grant program.

NCCAM SUCCESS RATE

Question. The success rate for research project grants in the National Center for

Complementary and Alternative Medicine is projected to be just 16 percent in fiscal

year 2002, compared with an NIH average of 30 percent. Why is it so low? What

can we do to bring that number up?

Answer. Success rates for Research Project Grants (RPGs), the ratio of RPG

awards to the total number of RPG applications received for a given fiscal year, represent a complex set of factors. Success rates typically vary among Institutes and

Centers, among RPG activities, such as single-investigator initiated traditional

grants (R01s) and multiple-investigator program projects (P01s), and among types

of grants, such as new grants, first time awardees, and competing renewals which

depend on the cycling of grants from noncompeting to competing status.

Furthermore, there is not a linear relationship between budget level, number of

applications, and number of awards. That is, an increase of twice the current budget

levels will not result in an increase in twice the number of applications or twice the

number of grants awarded. This is because the NCCAM portfolio is based on a number of interrelated mechanisms and factors, including the balance between intramural and extramural research, investigator initiated projects, contracts, and centers, as well as the number of grant applications, the size of grants, and the length

of project periods.

For the fiscal year 2002 President’s Budget submission prepared in early April,

NCCAM estimated it would receive 220 applications in fiscal year 2001, and 245 applications in fiscal year 2002, for an estimated success rate of 17 percent and 16

percent respectively.

It is difficult, however, for NCCAM to predict with certainty the number of applications it will receive. Investigator-initiated applications reflect the state of a particular arena of science, public health need, the maturity of a scientific field, and

even the morale of the scientific community. While the detailed outcomes of scientific discovery cannot be predicted, the current level of enthusiasm demonstrated

by the research community is expected to continue, and the potential of current scientific opportunities and the successes of the past lead us to predict that NCCAM’s

continuing investment in all mechanisms of research support will be easily repaid

in discoveries that will benefit the U.S. public.

Question. The President’s proposed NIH budget for fiscal year 2002 calls for an

increase of $2.74 billion, for a total of $23 billion. But he also wants to double the

fee for evaluation activities from 1 percent to 2 percent. Wouldn’t that change effectively reduce the NIH increase by $230 million?

Answer. As with most of the Department’s other public health agencies, NIH contributes its fair share of funds to the Public Health Service Evaluation Fund, as authorized under Section 241 of the PHS Act. NIH traditionally, provides about 70–

75 percent of these funds, reflecting the relative size of the NIH budget. These funds

have always been used to support health statistics surveys by CDC/NCHS, health

care services and health care quality research by AHRQ, and, as proposed for fiscal

year 2002, national data collection surveys by SAMHSA and policy research by

ASPE. NIH receives significant benefits from the projects supported through theses
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funds. By financing them through the PHS Evaluation Fund, the President’s Budget

proposes to more fully reflect the cross-cutting value of these health surveys and

health care research activities of NCHS, AHRQ, SAMHSA, and ASPE. Under the

fiscal year 2002 request, NIH’s evaluation fund share would increase by $189 million over its fiscal year 2001 contribution. Excluding the evaluation fund assessments in the base, as well as in the request, NIH’s proposed budget would still increase by nearly $2.6 billion, or ∂12.7 percent in fiscal year 2002.

QUESTIONS SUBMITTED BY SENATOR ERNEST F. HOLLINGS

RETINAL DEGENERATIVE DISEASES

Question. Macular degeneration is a major and growing public health problem.

Macular degeneration, Retinitis Pigmentosa and other retinal degenerative diseases

can lead to blindness. How is the National Eye Institute responding to this challenge?

Answer. Macular degeneration belongs to a group of retinal degenerative diseases

that includes retinitis pigmentosa (RP), Usher syndrome, Leber Congenital

Amaurosis, and allied diseases. As a group, these diseases are a major cause of

blindness and therefore a priority area of research focus for the intramural and extramural programs of the National Eye Institute (NEI). Macular degeneration affects the part of the retina responsible for sharp central vision. One form of the disease, age-related macular degeneration (AMD), is the leading cause of irreversible

vision loss in the United States among persons over 65 years of age, the fastest

growing segment of the US population. In spite of the public health significance of

AMD, there is no proven treatment for most affected persons and information about

its clinical course and the factors that predispose to it is limited. NEI-supported research on the identification of risk factors for AMD can help provide clues about the

etiology of the condition and help to develop possible strategies for intervention. Two

potentially modifiable risk factors, smoking and hypertension, have already been associated with the most severe form of AMD. The Age-Related Eye Disease Study

(AREDS) is an ongoing multi-center study of the clinical course of AMD to identify

additional risk factors for the development of high risk characteristics associated

with severe vision loss. Another part of this study is investigating the effect of antioxidants and zinc on the progression of AMD. A major clinical trial is also underway

to determine whether low intensity laser treatment can prevent the development of

advanced complications of AMD.

NEI-sponsored scientists recently reported the results of a gene transfer study

that restored sight in an animal model of the inherited retinal degeneration—Leber

Congenital Amaurosis. Continuation and expansion of this line of research offers

hope for children who are afflicted with this blinding condition and may lead to development of gene transfer therapy applications for other inherited retinal degenerations. Other scientists are actively pursuing laboratory and clinical studies on the

rescue and regeneration of deteriorating neurons; the identification of genes and

neurodegenerative mechanisms for macular degeneration, RP, and related disorders;

and the use of growth factors and transplantation, as well as gene therapy, as potential therapeutic measures. The goals of these studies are to increase understanding of the causes and mechanisms of cell death in retinal degenerative diseases, and to accelerate the development of innovative strategies to prevent, treat,

and cure these diseases.

LOW VISION

Question. Also, many eye diseases leave people with severely impaired vision. Is

the NEI doing anything to help them cope with their impairment and to improve

these individuals’ quality of life?

Answer. To address the special needs of those with uncorrectable visual impairment or low vision, the NEI supports a program of research on visual impairment

and its rehabilitation. Some individuals require simple optical or mechanical aids

to perform daily functions adequately, while others may need more specialized devices or environmental modifications. The NEI supports research to understand the

origins of visual impairment and assist in the rehabilitation of those who have such

disabilities. The NEI supports projects aimed at improving the methods of specifying, measuring, and categorizing loss of visual function; devising strategies to help

visually impaired people maximize the use of their residual vision; systematically

evaluating new and existing visual aids; developing an adequate epidemiological

base to understand the causes of blindness, partial loss of sight, and visual anoma-
408

lies; and studying the optical, electronic, and other rehabilitative needs of people

with visual impairments.

Additionally, the NEI established a Low Vision Education Program as a part of

its National Eye Health Education Program to increase awareness of low vision and

its impact on quality of life. This program is directed toward people with low vision,

their families and friends, and the health care and service professionals who care

for them. It takes particular note of the growing population of people over age 65

and other high risk populations, including Hispanics and African Americans who

are likely to develop low vision at an earlier age. As part of this education effort,

the NEI has developed a public service campaign and a mobile exhibit on low vision

that is currently traveling to shopping malls and centers throughout the United

States. It contains an interactive multimedia touch screen program; provides information on low vision services and resources; and displays aids and devices that help

people with low vision, all available in Spanish as well as English. The exhibit and

touch screen program explain the causes of low vision; offer personal accounts of

people living with low vision; and provide a self-assessment to help people determine if they or someone they know may have low vision.

QUESTIONS SUBMITTED BY SENATOR KAY BAILEY HUTCHISON

FUNDING COLLABORATION

Question. U.S./Israel Cancer Collaboration. I understand that the National Cancer

Institute recently funded a workshop to explore the feasibility of a U.S.-Israel collaboration on research projects related to cancer genetics. Please describe the intention of the NIH/NCI with respect to pursuing and funding this collaboration.

Answer. NCI staff participated in the workshop and related meetings in Houston

last fall to discuss this topic. The NCI was impressed with the list of areas of mutual interest for potential collaborations.

Since that meeting, the joint group has identified priorities for such collaborations. The goal is to facilitate collaborations that result in competitive research proposals that succeed in peer review.

Building toward this goal, NCI is working on two possible collaborations, both of

which are very preliminary at this time:

—Ovarian cancer screening study.—Researchers from the Hadassah Medical Organization in Jerusalem have expressed interest in collaborating in a trial of a

new screening strategy for women at high risk for ovarian cancer based in the

NCI’s Cancer Genetics Network (CGN). Israeli collaborators could contribute to

this trial through partnership with M.D. Anderson Cancer Center. A pilot study

to evaluate the feasibility of this trial is underway.

—Behavioral research.—Initial discussions between NCI staff and representatives

of Hadassah Medical Organization have identified areas of mutual interest in

research on the implications of testing individuals and families for genetic risk

factors. NCI is inviting Israeli investigators to participate in the CGN Behavioral Research Working Group to develop competitive grant applications for submission in the near future.

NCI has a strong, continuing interest in facilitating international research collaborations to meet research objectives that would be otherwise difficult to address

using only domestic resources. One high priority area is research on the implications

for the prevention and treatment of cancer posed by interactions between genes and

environmental exposures. The scarcity of appropriate high-risk individuals and families who have a genetic susceptibility and the costs associated with the necessary

studies has made it clear that national and international collaborations will be crucial to the success of our research enterprise.

Existing studies at the Weizmann Institute of Science, Rehovot, are aimed at understanding the mechanism of action of the p53 tumor-suppressor gene in its normal

(wild type) and mutated forms. Inactivation of the endogenous wild-type p53 gene

is associated with more than one-half of all cases of human cancer. Studies are focusing on the identification and characterization of genes involved in p53 regulation.

Other NCI-supported projects at the Weizmann Institute address (a) use of magnetic resonance imaging and spectroscopy as noninvasive procedures for early evaluation of breast cancer response to hormonal therapy and (b) investigation of molecular mechanisms through which the ErbB–2/HER2 oncoprotein contributes to

tumorigenesis in various adenocarcinomas.

At Tel Aviv University, NCI currently supports research on the neuroendocrine

and immunologic mechanisms underlying the modulatory effects of the estrous
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cycle, gonadal hormones, and gender on immune competence and tumor development.

NCI is also supporting an epidemiologic study of ovarian cancer at the Chaim

Sheba Medical Center, Tel Hashomer, to evaluate a broad range of potential risk

factors (e.g., reproductive, hormonal, nutritional, genetic, and occupational factors).

Genetic analysis is also being added to the study. Scientists are pursuing the possibility of performing a study to assess the role of the BRCA1 and BRCA2 genes in

prostate cancer risk, and a study of BRCA1 and BRCA2 gene mutations in male

breast cancer is also under way. In addition, a feasibility project is being conducted

to ascertain whether ataxia-telangiectasia is hereditary in approximately 24 candidate families and to determine procedures for a population-based study of cancer

risk in these families.

Mutations in the BRCA1 or BRCA2 gene are thought to account for about 90 percent of familial forms of breast cancer and ovarian cancer. In a study involving more

than 5,000 Ashkenazi Jewish volunteers from the Washington, DC area, mutations

in either BRCA1 or BRCA2 occurred in nearly 1 in 40. Collaborators on this project

included scientists from the Chaim Sheba Medical Center in Israel.

INTERNATIONAL COLLABORATIONS BY INSTITUTES

Question. Considering the success of international cooperation on the Human Genome Project, do you see advantages to similar collaboration with other nations, like

Israel, in other research areas, like cancer?

Answer. The NIH participates in a broad range of international collaborations

with many of the Institutes striving to develop and maintain a strong and diverse

selection of international collaborations and initiatives. For example:

National Cancer Institute (NCI)

NCI, in cooperation with extramural institutions and the Fogarty International

Center of the NIH, supports international health research through bilateral agreements, grants, and contracts. NCI supports some 1,000 Visiting Scientists and Exchange Scientists. The work of outstanding scientists throughout the world is supported through fellowships, cooperative projects, exchanges of personnel and materials, workshops and international dissemination of cancer information.

NCI’s international effort, coordinated by the Office of International Affairs (OIA)

within the Office of the NCI Director, works in conjunction with programs within

NCI’s divisions, at other NIH Institutes and the Fogarty International Center. Advances in cancer research result from NCI support and from support by other U.S.

and foreign government agencies, industries, private nonprofit institutes, and individual philanthropists.

One way in which NCI fosters joint research between U.S. and foreign scientists

is by cosponsoring international workshops. The NCI workshops program brings together small groups of U.S. and foreign scientists who are at the forefront of their

fields of research, to discuss their newest research that has not yet been published.

NCI is supporting several projects that are collaborative efforts with other countries:

—NCI supports the work of investigators at Tata Memorial Hospital, Bombay,

India, in a community-based randomized-control evaluation of low-cost methods

for early detection of common cancers in women. Breast and cervical cancers account for about 50 percent of cancer deaths in women in India. Among the diagnostic methods being evaluated are clinical breast examination without mammography, self-examination, and visual inspection of the cervix by trained female health workers. The goal is to reduce mortality by detection and diagnosis

of breast and cervical cancer at an early stage. This trial is one of the first of

its kind to be conducted in a developing country, and findings may be relevant

to other countries and populations with limited resources (e.g., underserved populations in developed countries).

National Institute of Allergy and Infectious Diseases (NIAID)

NIAID supports a broad research portfolio that encompasses multiple infectious

diseases including malaria, tuberculosis and HIV/AIDS. Because so many of these

diseases occur primarily or solely outside the United States but have the capacity

to emerge as public health threats in the U.S., NIH and NIAID have long recognized

that programs promoting international research efforts and other disease control

measures in the developing world can help to protect the health of Americans as

well as the health of people living in countries where these diseases have long been

endemic. Therefore, strengthening the research capability of scientists in their own

countries is an important focus of NIAID efforts. One of the cores of our international programs is the rich network of partnerships—a set of alliances for con-
410

ducting cutting-edge research, fostering good will, and transferring technical knowledge and know-how to research institutes and hospitals in regions of the world

where tropical diseases are endemic. The alliances encourage U.S. scientists to work

in and obtain expertise on disease issues in those regions. They also enable investigators from those areas to collaborate on research projects on site and to visit U.S.

laboratories and attend scientific conferences and workshops to discuss with global

experts the challenges of studying and combating these diseases.

International Centers of Excellence:

An important component of the NIAID Strategic Plan is a focus on addressing

global health disparities. In order to address the disproportionate burden of infectious diseases on third world countries, NIAID is in the process of setting up International Centers of Excellence (ICERs). These research centers will be joint ventures between NIAID’s intramural and extramural divisions and host nations. Extensive infrastructure improvements, equipment procurement and personnel and financial resources will be crucial to the success of these endeavors. Three sites have

been identified by the NIAID:

—The Tuberculosis Research Center (TRC) in Chennai, India will be the base for

an ICER to expand research on tuberculosis, lymphatic filariasis and HIV. Research will initially focus on the interaction between pre-existing helminth infection and mycobacterial infection, studies of chemotherapy of TB in HIV infected patients and the influence of non-HIV infections on HIV expression.

Longer term goals include understanding the interaction between allergic disease and helminth infection, the genetics of asthma in a tropical setting, drug

resistance in both helminth infection and TB, and possible assessments of vaccines for Plasmodium vivax, TB, HIV or group A streptococcus.

—The Rakai District in southwestern Uganda will be a base for an ICER to focus

on HIV and STDs, including the effects on pregnancy, fertility, infant survival,

placental pathology and mother-to-child HIV transmission.

—The Papua New Guinea Institute of Medical Research will be the site of an

ICER to conduct malaria vaccine studies. The development and testing of asexual blood stage malaria vaccines will be the primary focus.

HIV Networks:

MAID supports two global research networks, the HIV Vaccine Trials Network

(HVTN) and the HIV Prevention Trials Network (HPTN). The HVTN is a network

of clinical sites in the United States and abroad that is dedicated to the development of an HIV vaccine through testing and evaluating candidate vaccines in clinical trials. The network includes 11 sites in the United States and eight sites overseas, including sites in Africa, Asia, South America, and the Caribbean. The HVTN’s

global capacity will allow for rapid expansion as more vaccine candidates enter the

pipeline for testing and development, and for carrying out larger scale studies of

suitable vaccines.

—The HPTN evaluates the safety and efficacy of non-vaccine prevention interventions, alone or in combination, using HIV incidence as the primary endpoint.

Because HIV is transmitted via different routes in different populations, developing a variety of HIV prevention strategies will have a significant impact on

reducing transmission rates and slowing the spread of HIV worldwide. Research

through the HPTN is carried out through HIV Prevention Trials Units (HPTUs)

located at nine sites in the United States and 16 sites overseas in Africa, Asia,

Europe and South America.

—More recently, NIAID released a new grant program called the Comprehensive

International Program of Research on AIDS (CIPRA). The goals of CIPRA are

to provide long-term support to researchers and institutes in developing countries to (1) plan and implement a comprehensive HIV/AIDS prevention and

treatment research agenda relevant to their populations; and (2) enhance the

infrastructure necessary to conduct such research.

International Histocompatibility Working Group (IHWG):

NIAID is the primary sponsor of IHWG, a multi-national collaboration of more

than 400 laboratories in 79 countries. The collective goal of this large group is to

study the tremendous diversity of the human leukocyte antigen (HLA) gene complex, the most variable region of the human genome, and how this diversity affects

human health. Genes of the HLA complex control immune responses and therefore

determine an individual’s resistance or susceptibility to autoimmune and infectious

diseases. The HLA gene complex contains over 220 identified genes. Each gene may

be present in several different forms (alleles), and there are over 1,000 different

alleles of HLA genes. This degree of sequence variability makes the HLA complex

a uniquely valuable tool in analyzing human diversity and measuring the related-
411

ness of distinct geographic, ethnic, and racial populations. Another feature of the

IHWG that will facilitate its efforts is access to large cohorts of diverse ethnic and

geographic origins. This provides tremendous statistical power for the populationbased studies of HLA genetics in human diversity, transplantation, autoimmune diseases, and immune responses to infectious agents.

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIDCD continues to support an international consortium with the purpose of expediting the discovery of genes responsible for hereditary hearing impairment. The

consortium encompasses research on nonsyndromic and syndromic forms of hereditary hearing loss, such as Waardenburg syndrome and Usher syndrome. Scientists

from countries including Belgium, Colombia, Finland, France, Germany, Israel,

Japan, Norway, South Africa, and the United Kingdom, as well as scientists

throughout the United States, continue their efforts to map the genes responsible

for syndromic and nonsyndromic hereditary hearing impairment. Almost 60 genes

have been identified for recessive and dominant nonsyndromic hereditary hearing

impairment in families from Colombia, India, Indonesia, Israel, Lebanon, Newfoundland, Pakistan, Tunisia, and the United States, including Puerto Rico. The collaborative efforts fostered by the consortium have been instrumental in identifying a

large number of the genes responsible for hereditary hearing impairment and in advancing the understanding of these disorders.

The Laboratory of Molecular Genetics established a collaboration with the University of Toronto on a study of hereditary deafness in Ashkenazi Jews and is actively

working on the genetic mapping and identification of a novel deafness gene in a

large Ashkenazi Jewish family. This has already resulted in one publication about

the hearing status associated with a particular allele (variant) of a known deafness

gene called connexin 26 (GJB2).

NIDCD is also collaborating with the Instituto di Genetica Molecolare of the

Consiglio Nazional delle Recerche (Institute of Molecular Genetics, National Research Council), Alghero, Sardinia, Italy in a study of inherited deficits in the sense

of bitter taste. This laboratory has developed a unique study population in the

Ogliastra region of Sardinia, consisting of a number of genetically isolated villages.

Such populations provide important experimental advantages of the study of common recessive genes, such as those that cause deficits in the sense of bitter taste

in individuals of European origin. The goal of this research is to identify the genes

which cause this deficit to better understand the molecular mechanisms involved in

the sense of bitter taste in humans.

In another collaboration between NIDCD’s Laboratory of Cellular Biology and the

faculty at the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel an

attempt is underway to determine the pattern of expression and biological effects

of Myosin VI during development of the auditory system. Myosin VI has been shown

to be required for development of hair cells and for hearing, however the specific

effects of this protein have not been determined.

National Center for Complementary and Alternative Medicine (NCCAM)

The National Center for Complementary and Alternative Medicine, in collaboration with Johns Hopkins University, Johns Hopkins Singapore and the National

University of Singapore, is co-sponsoring a research symposium on traditional Chinese medicine and a workshop on clinical methodology and grantsmanship in November 2001. The symposium will present state of the art research in traditional

Chinese medicine from investigators in the region. The goal of the workshop is to

train potential scientific collaborators in the necessary skills to successfully compete

for National Institutes of Health grants. Scientific data and conclusions from grantees in Southeast Asia, where traditional medicine is widely practiced and accepted,

will broaden the knowledge base of complementary and alternative medicine interventions while providing important information on chronic diseases such as cancer

and cardiovascular disease that can be targeted to reduce health disparities in

Asian populations in the U.S.

Fogarty International Center (FIC)

The Fogarty International Center (FIC), the international arm of the NIH, promotes and supports international collaborations to advance medical research in virtually every area of science on behalf of the NIH. In addition, FIC focuses attention

on the scientific opportunities and needs of low- and middle-income countries and

works to reduce disparities in global health. Working through over 20 programs and

in partnership with other NIH components, U.S. agencies and foreign counterparts,

the FIC tackles global health challenges such as AIDS, mental illness, tuberculosis

and maternal and children’s health. FIC works through bilateral and multilateral

arrangements, at times involving formal intergovernmental discussions and agree-
412

ments, and more frequently through scientist-to-scientist exchanges. Illustrative examples of FIC-led programs include:

Multilateral Initiative on Malaria (MIM):

Launched in 1997, the MIM brings together countries from around the world in

an effort to speed discoveries in malaria research while at the same time building

capacity in countries most affected to employ state-of-the-art prevention and control

technologies. Among its partners are public and private science funding agencies in

Great Britain, France, Japan and Norway, as well as the World Health Organization and the World Bank. Since 1999, FIC has served as the MIM Secretariat, and

has advanced the MIM agenda in partnership with other NIH ICs including NIAID

and NLM by: increasing malaria research funding, increasing internet access for

malaria researchers, expanding the numbers of MIM sponsors, improving the sharing of research resources for malaria, and establishing new opportunities for the

training of African scientists in this critical field. In addition, MIM has just recently

initiated and supported the development of new estimates of malaria mortality, now

known to be close to 3 million deaths per year, primarily in sub-Saharan Africa and

in children under the age of five, in addition to significant disability and morbidity

in Africa, Latin America and Asia.

AIDS International Training and Research Program:

Working primarily through U.S. universities, FIC supports training of scientists

and health professionals from the developing world as part of international collaborative research programs. This training includes Ph.D. or Master’s level degrees and

is the largest program contributing to capacity to confront the AIDS epidemic in

countries hardest hit. Graduates of this training are now the leaders in their country, reaching senior level positions in Ministries of Health, including the Minister

of Health position. They will be essential to the design and conduct of clinical trials

to test new AIDS prevention, vaccines, and treatment technologies and to ensure

that such trials are conducted with scientific rigor as well as in accordance with

international and local ethical norms. FIC’s program, which works closely with all

relevant NIH components, has led to the development of scientific infrastructure in

countries such as Uganda and Senegal where HIV infection rates have been reduced

dramatically or held at a low level, respectively.

Pan American Fellowship Program:

Begun with NIH counterparts in Mexico in 1995, the Pan American Fellowship

Program brings post-doctoral scientists to the NIH laboratories in Bethesda for advanced training in a range of scientific areas. Building on mutual strengths and interests, fellows receive training under the mentorship of chief NIH scientists in

areas such as neurobiology, infectious disease, genetics and maternal and children’s

health. Every year, fifteen to twenty trainees participate in this program, which is

sponsored on a cost-shared basis by both countries. Based on the success of the effort with Mexico, FIC expanded the program recently to include other Latin American countries such as Argentina, Colombia, Chile, Costa Rica, and Uruguay, with

additional support from the Pan American Health Organization to co-sponsor from

other countries in the Latin American and Caribbean region.

National Institute of Neurological Disorders and Stroke (NINDS)

In November 2000, NINDS, on behalf of the United States, signed a Memorandum

of Understanding (MOU) with the National Institute for Physiological Sciences at

Okazaki, representing Japan. The purposes of this cooperative program are to stimulate studies of the molecular, cellular, and integrative mechanisms of mammalian—including human—brain function. The MOU will establish a cooperative program that will be open to all neuroscientists in both countries. Associated activities

may include collaborative research projects, information sharing through workshops

and seminars, short-term exchanges of scientists and other relevant activities. We

believe that new knowledge about the brain and the nervous system gained through

this agreement will favorably impact the health of all populations.

National Institute of Dental and Craniofacial Research (NIDCR)

Genetics of Cleft Lip and Palate:

NIDCR supports a project with the World Health Organization to serve as the

umbrella organization for the development and maintenance of a global research

network in the area of craniofacial anomalies (CFA). Such a network links U.S. and

NIH-funded researchers with other researchers, and provides access to populations

in other parts of the world for studies regarding the genetic and environmental

causes of CFA, the health care systems and treatment methodologies which lead to
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the best outcomes for those children born with CFA, and ways to reduce the incidence or prevent these birth defects.

As a result of this collaboration, significant progress has recently been achieved

in understanding the genetics of cleft lip and palate. An NIDCR-supported research

team reported the discovery of the gene responsible for cleft lip and palate when

it occurs as part of a syndrome that also includes defects in the skin, teeth, and

hands. The gene, called PVRL1, codes for a molecule that is important for cell adhesion. Mutations in the PVRL1 gene are responsible for a recessive cleft lip and palate syndrome, called CLPED1, which occurs with a high frequency among the population of Margarita Island. More recently, this research team has found preliminary

evidence that individuals carrying one copy of the mutated gene have an increased

risk for cleft lip and palate that is not associated with the other defects of the syndrome. These results may lead to the development of early diagnostic tools and prevention strategies for cleft lip and palate.

National Institute Drug Abuse (NIDA)

Pandemics such as drug abuse and HIV/AIDS require that we bring the full power

of science to bear on these complex public health problems. Toward this end, NIDA

has several collaborative efforts underway with the nations of Thailand and South

Africa that will likely have advantages to enhance both the U.S. and the participating country’s research agenda.

For example, given the extremely high rates of methamphetamine abuse in Thailand, and as a follow-up to the Pacific Regional Research Conference on Methamphetamine and Amphetamine-Type Stimulants, held in November 2000 in Bangkok, Thailand, NIDA has been working with the Thai government to determine

ways to best prevent and treat addiction to this powerful stimulant. Thailand presents some unique opportunities for collaborative efforts. For one, the government

in Thailand is very enthusiastic and committed to focusing on its methamphetamine

problem. The population of methamphetamine abusers is also unique because of the

age and symptoms of those who are abusing. Use begins at a very early age in Thailand, typically before the teen years. By the age of 12, some of these children are

being diagnosed with long-term psychosis. There is much we can learn by studying

this population, especially as the drug continues to spread in our own country. Also

given that there are currently no medications available in the U.S. or elsewhere to

combat this addiction, there is a behavioral treatment model (MATRIX) that has

proven successful in the United States. This model is now being used in Thailand

to help deal with their methamphetamine epidemic.

A second example of a collaborative research effort that will likely directly benefit

the citizens of both nations is the efforts that NIDA has underway with South Africa. NIDA has been working with South Africa on an informal basis for over a year,

but is interested in stimulating more formalized bi-national collaborative drug abuse

research between the United States and South Africa. South Africa has one of the

fastest growing rates of the HIV infections in the world. Although we have learned

much about preventing and treating HIV/AIDS in the United States, very little is

known about the potential for replicating science-based prevention and treatment

approaches in settings outside of the U.S. Given the many similarities between the

two countries transmission patterns and the cultural diverse populations of its citizenship, there is much the U.S. can learn from South Africa as it attempts to prevent HIV/AIDS with lessons learned from the U.S.

Finally, NIDA has also begun a collaborative research initiative with the Dutch

government that includes efforts to explore areas of mutual interest. One important

area is the growing use of MDMA, or ecstasy, and its short and long term effects

on the brain. NIDA is hosting a workshop this fall with U.S. and Dutch researchers

to review the current science and to plan for future collaborative research projects.

National Institute of Mental Health (NIMH)

As the world leader in research on effective behavioral strategies to decrease and

prevent the spread of AIDS, the National Institute of Mental Health is involved in

a number of international collaborative efforts that provide the opportunity to disseminate and build upon the knowledge gained, ease the burden of disease and prevent the international spread of a devastating disease. NIMH is supporting the first

international trial of a U.S. tested model of community-level HIV/STD behavioral

prevention program. The NIMH Collaborative HIV/STD Prevention Trial is a twoarm randomized, community-level trial being conducted in six countries—China,

India, Peru, Russia, Uganda, and Zimbabwe. In addition, research collaborative

agreements with the research ministries of the governments of India and South Africa have resulted in increasing the quality of the HIV behavioral prevention studies

and helping to develop the research capacity of these countries.
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With mental illnesses occupying such a prominent place in the global burden produced by disease, the NIMH also supports mental health research in over three

dozen foreign countries.

National Institute of Child Health and Human Development (NICHD)

NICHD, in partnership with both other NIH Institutes and the Gates Foundation,

has developed and implemented a Global Network for Women’s and Children’s

Health Research. This large, international collaborative effort is essential to addressing the leading causes of morbidity and mortality in children and women of

child-bearing age in resource-poor settings. Through partnerships between leading

U.S. researchers and senior foreign investigators, interventions to reduce maternal

and child morbidity and mortality will be tested for efficacy with advance planning

that will permit the rapid and sustainable implementation of interventions judged

by rigorous research to be successful.

The NICHD-sponsored study, The Hyperglycemia and Adverse Pregnancy Outcome Study is an epidemiologic investigation to clarify the association of various levels of glucose intolerance during the third trimester of pregnancy and the risk of

adverse outcomes. This international collaborative study will enroll 25,000 women

in the U.S., Australia, Canada, China, Israel, the Netherlands, the Republic of

Singapore, Thailand, the United Kingdom and the West Indies. The study is examining glucose intolerance in a large heterogeneous, multinational ethnically diverse

cohort of women in the third trimester of gestation. This international collaboration

has been carefully planned and will generate robust data on the global incidence

of gestational diabetes that will provide definitive international reference standards.

This cooperative study makes use of state-of-the-art laboratory and measurement

techniques and, via frequent steering committee meetings, facilitates the sharing of

creative and innovative scientific thinking from around the globe. NICHD and

NIDDK are acting jointly to support this important investigation.

The Trial to Reduce the Incidence of Type I Diabetes Mellitus in the Genetically

at Risk will test the hypothesis that a nutritional intervention during infancy will

reduce the incidence of type I diabetes in genetically susceptible infants. This randomized, prospective controlled clinical trial will enroll a total of 2,370 infants in

the United States, Australia, Canada, Estonia, Finland, France, Germany, Hungary,

Italy, Netherlands, Poland, Russia, Spain, Sweden, and Switzerland. The public

health implications of this nutritional intervention will be enormous if proven successful. This study represents a collaborative international effort involving funds

from the NICHD, other NIH Institutes, the Juvenile Diabetes Research Foundation,

the Canadian Institutes of Health Research, and the European Foundation for the

Study of Diabetes. Thus, financial contributions from both the U.S. and abroad, innovative collaborative scientific thought from an international group of

diabetologists and pediatricians from the nations noted above, and enrollment of a

large and diverse population will synergistically act to answer a critical public

health question.

The NICHD is developing a potentially very promising research initiative with

India. This initiative will foster joint research on the leading causes of morbidity

and mortality among women of child bearing age and children. It also will support

joint HIV/AIDS research, particularly on the prevention of HIV transmission from

mothers to their children, and research on reproductive health and sexual behavior.

Pursuing these lines of research in India offers great opportunities to U.S. scientists

because Indian biomedical and behavioral scientists are well trained and supported

by relatively strong scientific institutions. Also, because of the growing AIDS epidemic in India and the prevalence of many diseases and conditions in Indian populations of women and children, India offers unique opportunities to study new ways

to improve health in large populations. Furthermore, the Government of India is

committed to research co-funding so U.S. Government funding can be multiplied.

NICHD also sees important opportunities for research collaboration in Africa,

which has the greatest burden of maternal and child morbidity and mortality. Research on HIV/AIDS, infectious diseases including sepsis, upper-respiratory diseases

and nutrition-related disorders are a few examples of areas where research in Africa

holds great potential for new discoveries. In Africa it also is most cost-effective to

mount programs on a regional basis to maximize the use of trained investigators

and to assure lessons learned are applied to the greatest benefit. Through the Global Network for Women’s and Children’s Health Research, which is co-funded by the

Gates Foundation, NICHD plans to expand joint research in Africa on critical maternal and child health interventions specifically developed for developing countries.

This promising program is a model for public-private partnership as well as international research collaboration.
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National Institute of Environmental Health Sciences (NIEHS)

Among the many reasons for pursuing international collaborations are that some

phenomena—both tools and conditions—exist in other countries that do not exist in

the U.S. One is the availability of information. NIEHS is initiating a collaborative

cohort study with scientists and health officials in Norway to study pregnant women

and their children; this study takes advantage of that country’s system of socialized

medicine both to enroll the women (a very high percentage of women obtain early

prenatal care) and to follow them and their children. Other studies, particularly in

the field of environmental health, cast a global net to find populations and regions

with higher exposure levels to pollutants of interest, in which the divisions between

exposed and unexposed populations are more clearly delineated and epidemiological

studies are more likely to provide clear information of either an association or a lack

of an association with disease. For instance, most of the information we have used

in the U.S. to assess risks from mercury exposure have come from studies in the

Faroe Islands in the North Atlantic and from the Seychelles Islands off the coast

of Africa, where the people eat a great deal of fish and their mercury exposure

comes through that route.

SUCCESS RATE FOR GRANT SUBMISSIONS

Question. Mental Health/National Institute of Mental Health. Where does the National Institute of Mental Health (NIMH) stand relative to other NIH institutes on

the rate of grants submitted and funded?

Answer. In fiscal year 2000 the average success rate (awarded grants as a percentage of total grant applications) for research project grants was 32 percent NIHwide. Success rates across the 21 NIH Institutes and Centers ranged from a high

of 43 percent to a low of 18 percent. The NIMH ranked 13th from the highest with

a success rate of 29 percent.

QUALITY OF SCIENCE IN GRANT SUBMISSIONS

Question. Is the relative quality of science in the grant submissions and proposals

received by NIMH rising or declining?

Answer. The striking growth and scientific development of the field of neuroscience over the last decade has served to drive a rapid, sustained expansion of the

number of very high quality research programs in the areas of basic and clinical

neuroscience. This expansion of excellent research programs has meant that the

pool of outstanding NIH grant applications has grown at a corresponding rate.

NIMH has ‘‘turned the corner’’ in substantially upgrading its research portfolio and

retargeting research opportunities. This has resulted in a much larger pool for these

areas of outstanding applications that are truly significant for NIMH’s mission.

Similar NIMH efforts in the areas of services and intervention research have been

successful in producing and expanding a high-quality pool of better-targeted applications.

BUDGETARY INCREASES

Question. Can NIMH efficiently spend the increases enacted by Congress in fiscal

year 2000 and fiscal year 2001 again in fiscal year 2002, i.e. will good science continue to keep pace with budgetary increases?

Answer. Yes. The science related to the brain and to behavior is at the frontier

that now attracts the most talented investigators in the country. With the recent

budget increases, NIMH has undertaken new initiatives in several scientific areas—

basic and clinical neuroscience, and behavioral science—that are poised for rapid development because of technological innovation and dramatic growth in our understanding of brain function. In addition, NIMH has targeted a significant portion of

its funding to initiatives deemed by the public and Congress to be health emergencies including research on the use of psychotropic medications in children, youth

violence in our schools and communities, and suicide prevention. Also of note, NIMH

recently launched several large clinical treatment trials to determine the most effective treatments for people with some of the most disabling mental illnesses (schizophrenia, bipolar disorder and depression). These are areas in which unprecedented

advances in our understanding have emerged coincident with critical public health

needs.

Judging from peer review ratings and programmatic relevance, the quality of the

grant applications received in response to the majority of these initiatives has been

outstanding. The fiscal year 2002 Budget level would allow additional initiatives,

determined by a selective NIMH planning process, to come on-line expeditiously.

Initiatives recently implemented, and those planned for fiscal year 2002, are focused
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on topics such as development of therapeutics, training investigators for clinical research, and genetic/molecular neuroanatomy of the brain. Special emphasis is being

placed on severe mental disorders, including, for example, a major new centers program for autism research.

INFORMATION DISSEMINATION

Question. In the last decade, many new treatments and services have been developed and proven for severe mental illnesses such as schizophrenia. Yet most individuals with these illnesses receive less than optimal care. What steps can the NIH/

NIMH take to ensure that improvements in treatments and therapies can be effectively disseminated to providers and patients?

Answer. NIMH focuses on research that helps to reduce the burden of mental disorders for the American public. The Institute’s research program aims to translate

the understanding of basic biological and genetic processes, including knowledge of

mechanisms underlying thought, emotion, and behavior, into effective treatments

that reach patients with mental illness. NIMH’s new generation of ‘‘real-world’’

treatment effectiveness studies will raise the standard of care for several major

mental disorders, including schizophrenia and bipolar disorder (manic-depressive illness), by determining the best existing treatments in thousands of patients across

the U.S. The National Advisory Mental Health Council (NAMHC) did a study of the

effects of parity for mental health benefits which helps policymakers and the public

to have the appropriate information about the costs of providing mental health insurance coverage.

Through its Office of Communications and Public Liaison (OCPL), NIMH publishes and disseminates research-based information on mental disorders and their

treatment for diverse audiences including the general public, people with mental

disorders and their families, health care providers, mental health professionals, scientists, advocates, and the media. Materials that cover the wide range of disorders

and research areas funded by the Institute are available both in print and on the

Web. At this time, the NIMH Web site (http://www.nimh.nih.gov) is receiving approximately 7 million hits each month; and recently it received commendation for

the quality of its information, especially on depression.

NIMH also supports a continuing Dissemination Research Program dedicated to

improving communication of research evidence to providers, patients, and other

stakeholders. A program highlight in the latest funding cycle is a new study evaluating a web-based information system for families and patients dealing with schizophrenia. Furthermore, through the Small Business Innovation Research contract

program, NIMH is reviewing proposals to develop dissemination tools for schools

and other community settings. The Institute is collaborating with the National Association of State Mental Health Program Directors to organize workshops in the coming months to raise the profile of dissemination and evidence based treatment for

mental health in children. NIMH/NIH is also partnering with other HHS agencies

(ASPE, AHRQ, CDC, HRSA) in an initiative to examine dissemination and diffusion

of research findings and to focus on dissemination efforts. In April 2001 NIMH

sponsored a workshop on Implementing Evidence-Based Practice in the Public Mental Health Sector.

CONCLUSION OF HEARINGS

Senator SPECTER. Thank you all very much for being here. That

concludes our hearing.

[Whereupon, at 9:55 a.m., Wednesday, May 23, the hearings was

concluded, and the subcommittee was recessed, to reconvene subject to the call of the Chair.]
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1The Tribal Colleges and Universities are accredited by regional accreditation agencies and

must undergo stringent performance review on a periodic basis. The higher education division

of the respective regional accreditation agency accredits twenty-seven of the TCUs. Two new

TCUs are at the Pre-candidate stage as they complete work to attain Candidate status; one TCU

is at Candidate status. Two TCUs are accredited as ‘‘Vocational/Adult Schools by the ‘‘schools’’

division of the respective regional accreditation agency.

DEPARTMENTS OF LABOR, HEALTH AND

HUMAN SERVICES, AND EDUCATION, AND

RELATED AGENCIES APPROPRIATIONS FOR

FISCAL YEAR 2002

U.S. SENATE,

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS,

Washington, DC.

NONDEPARTMENTAL WITNESSES

[CLERK’S NOTE.—The subcommittee was unable to hold hearings

on nondepartmental witnesses. The statements and letters of those

submitting written testimony are as follows:]

DEPARTMENT OF EDUCATION

PREPARED STATEMENT OF THE AMERICAN INDIAN HIGHER EDUCATION CONSORTIUM

Mr. Chairman and Members of the Subcommittee, on behalf of this nation’s 32

Tribal Colleges and Universities, which comprise the American Indian Higher Education Consortium (AIHEC), we thank you for the opportunity to share our fiscal

year 2002 funding requests for programs within the Department of Education.

This statement will cover two areas (a) background on the tribal colleges, and (b)

justifications for our funding requests.

BACKGROUND ON TRIBAL COLLEGES

The Tribal College Movement was launched in 1968 with the establishment of

Navajo Community College, now Dine ́ College, in Tsaile, Arizona. A succession of

tribal colleges soon followed, primarily in the Northern Plains region. In 1972, the

first six tribally controlled colleges established AIHEC to provide a support network

for member institutions. Today, AIHEC represents 32 Tribal Colleges and Universities in 12 states and one in Canada, created specifically to serve the higher education needs of American Indian students. Collectively, they serve 25,000 students

from over 250 federally recognized tribes.

Tribal colleges offer primarily 2-year degrees, although in recent years some institutions have begun to offer baccalaureate and graduate-level degrees. The vast majority of the tribal colleges are fully accredited by independent, regional accreditation agencies.1 In addition to college level programming, tribal colleges provide

much needed high school completion (GED), basic remediation, job training, college

preparatory courses, and adult education. Tribal colleges fulfill additional roles

within their respective communities functioning as community centers, libraries,

tribal archives, career and business centers, economic development centers, publicmeeting places, and child care centers. An underlying goal of tribal colleges is to

improve the lives of students through higher education and to move American Indians toward self-sufficiency.
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Tribal colleges provide needed access to higher education for American Indians

and others living in mostly remote, economically depressed areas of the country.

These institutions are chartered by their respective tribal governments and were established in response to the recognition by tribal leaders that local, culturally-based

education institutions are best suited to help American Indians succeed in higher

education. Tribal colleges combine traditional teachings with conventional postsecondary courses and curricula. They have devised innovative means to address the

needs of tribal populations in economically depressed regions and are successful in

overcoming long-standing barriers to Indian higher education. Since the first tribal

college was established on the Navajo reservation, these vital institutions have come

to represent the most significant development in the history of American Indian

higher education, providing access to under-represented students and promoting

achievement among students who may otherwise never have known post-secondary

education success.

Funding of tribal colleges is grossly inadequate. While these institutions have successfully negotiated many challenges in the history of the Tribal College Movement,

adequate funding remains the most significant barrier to their ongoing success. Core

operational funding for 25 tribal colleges is provided through the Tribally-Controlled

College or University Assistance Act (TCCUAA), Public Law 95–471. Funding was

first appropriated through the Act in 1981, and is still less than two-thirds of its

Congressionally authorized level of $6,000 per full-time Indian student. In fiscal

year 2001, the Colleges received $3,849 per full-time Indian student. Moreover, this

amount is less than two-thirds of the estimated $6,089 per full-time student received by mainstream community colleges. While mainstream institutions have a

foundation of stable state support, tribal colleges must rely on the Federal government for operational funding. Because tribal colleges are located on federal trust

territories, states have no obligation to fund them. In fact, most states do not even

fund our colleges for the non-Indian state-resident students who account for approximately 20 percent of our enrollments.

Since their inception, tribal colleges have achieved exceptional growth and success, yet they are the most poorly funded higher education institutions in America.

Although conditions at some have improved substantially, many colleges still operate in trailers; cast-off buildings; and facilities with crumbling foundations, faulty

wiring, and leaking roofs. Sustaining quality academic programs is a challenge without a reliable source of facilities maintenance and construction funds.

Today, one in five American Indians live on reservations. As a result of 200 years

of Federal Indian policy—including policies of termination, assimilation and relocation—many reservation residents live in abject poverty comparable to poverty found

in Third World nations. Through the efforts of tribal colleges, American Indian communities receive services they need to reestablish themselves as responsible, productive, and self-reliant citizens.

JUSTIFICATIONS

Higher Education Act requests.—The Higher Education Act Amendments of 1998

created a separate section within Title III, Part A, specifically for the nation’s tribal

colleges (Section 316). The Aid for Institutional Development programs, commonly

known as the Title III programs, support minority institutions and other institutions that enroll large proportions of financially disadvantaged students and have

low per-student expenditures. Tribal colleges clearly fit this definition. Tribal colleges are among the most poorly funded institutions in America, yet they serve some

of the most impoverished areas of the country. They fulfill a vital role of providing

access to quality higher education programs, which are specifically designed to focus

on the critical, unmet needs of their American Indian students and communities.

This funding will help the tribal colleges effectively prepare their students for the

workforce of the 21st Century in a safe environment. The President’s budget recommendation included increases for the Historically Black Colleges and Universities

programs, and the Hispanic Serving Institutions line item under this program,

while the tribal colleges’ account was level funded. We strongly urge the Subcommittee to correct this oversight and fund this section—which is critical to the

tribal colleges—at $25 million. We ask that $10 million of these funds be specifically

designated for the competitive facilities and infrastructure improvement program

created in fiscal year 2001, also administered under this section.

The importance of Pell grants to our students cannot be overstated. Department

of Education figures show that at least half of all Tribal College students receive

Pell grants, primarily because student income levels are so low and our students

have less access to other sources of aid than students at mainstream institutions.

Within the Tribal College system, Pell grants are doing exactly what they were in-
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tended to do—they are serving the needs of the lowest income students by helping

people gain access to higher education and become active, productive members of

the workforce. We urge you to build upon increase recommended in the President’s

fiscal year 2002 budget.

Perkins Vocational Education Act.—Section 117 (addressing Tribally-Controlled

Postsecondary Vocational Institutions) of the Carl D. Perkins Vocational and Applied Technology Education Act provides core funding for two of our member institutions: United Tribes Technical College in Bismarck, North Dakota, and Crownpoint

Institute of Technology in Crownpoint, New Mexico. We support the $5.6 million included in the President’s budget request for the Tribally-Controlled Postsecondary

Vocational Institutions under Section 117. We request report language reaffirming

that this funding remain specific to these two Tribally Controlled Postsecondary Vocational Institutions.

Greater Support of Indian Education Programs Under ESEA

American Indian Adult and Basic Education.—This section supports adult education programs for American Indians that are offered by tribal colleges, state and

local education agencies, Indian tribes, institutions, and agencies. Unfortunately,

the section has not been funded since fiscal year 1995. The Tribal College Act does

not include funding for remediation and adult basic education, as it only supports

those students enrolled in postsecondary programs. Yet, the tribal colleges must

continue to provide basic adult education classes for their communities. Before many

individuals can even begin the course work needed to learn a productive skill, they

first must earn a GED or, in some cases, learn to read. According to a 1995 survey

conducted by the Carnegie Foundation for the Advancement of Teaching, 20 percent

of the participating students had completed a tribal college GED program before beginning formal classes at the tribal college. At some schools, the percentage is even

higher. Lac Courte Oreilles Ojibwa Community College in Hayward, Wisconsin, for

example, reports that nearly one-third of its students had earned a GED through

its tutoring and testing center. Clearly, the need for basic educational programs is

tremendous, and tribal colleges need funding to support these crucial activities.

Tribal colleges need a minimum of $5 million to meet the ever-increasing demand

for basic adult education services. Without this minimum commitment, vitally needed services for our adult student population cannot be sustained, much less increased to address the full need. It is our hope that Congress will rectify this serious

oversight in fiscal year 2002.

American Indian Teacher Corps.—American Indians are severely under-represented in the teaching ranks nationally. This program, aimed at producing 1,000

new teachers for schools serving American Indian students, would provide for fellowships to college students majoring in education programs and for professional development programs in Indian Country to support current teachers. We believe that

the tribal colleges are the ideal catalysts for this initiative because of our current

work in this area and the existing articulation agreements tribal colleges hold with

4-year higher education institutions. We request Congress continue to support this

$10 million program, included in the President’s fiscal year 2002 budget request, to

increase the number of qualified American Indian teachers in Indian Country.

American Indian Administrator Corps.—In fiscal year 2001, a new program was

funded to establish the American Indian Administrator Corps. Like teachers, American Indian school administrators are severely under-represented in the profession

nationally. This program will support the recruitment, training, and in-service professional development of 500 American Indians and Alaska Natives to become effective school administrators in schools with large Native American populations. We

request Congress continue to support this $5 million program, included in the President’s fiscal year 2002 budget request, to increase the number of American Indian

school Administrators in Indian Country.

CONCLUSION

Fulfillment of AIHEC’s fiscal year 2002 request will strengthen the mission of the

Tribal Colleges and Universities, and contribute to the enormous, positive impact

they have on their respective communities. Moreover, it will help ensure that American Indians will be properly educated and prepared for the workforce of the 21st

Century. As the 1997 Carnegie Report on tribal colleges stated:
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2Paul Boyer, Native American Colleges: Progress and Prospects. Princeton, NJ: Carnegie

Foundation for the Advancement of Teaching, 1997.

‘‘Now, as strongly as ever, we repeat our conviction that tribal colleges deserve

continued support. Their value has been proven, but their vision is not yet fulfilled.’’ 2

Tribal colleges have been extremely responsible with the Federal support they

have received over the last 20 years, and have proven themselves to be a sound federal investment.

Thank you again for this opportunity to present our funding requests before this

Subcommittee. We respectfully ask the Members of this Subcommittee for their continued support and full consideration of our fiscal year 2002 appropriations request.

PREPARED STATEMENT OF THE AMERICAN MUSEUM OF NATURAL HISTORY

ABOUT THE AMERICAN MUSEUM OF NATURAL HISTORY

The American Museum of Natural History [AMNH] is one of the nation’s preeminent institutions for scientific research and public education. Since its founding

in 1869, the Museum has pursued its mission to ‘‘discover, interpret, and disseminate—through scientific research and education—knowledge about human cultures,

the natural world, and the universe.’’ It is renowned for its exhibitions and collections of more than 32 million specimens and cultural artifacts. With nearly five million annual visitors—approximately half of them children—its audience is one of the

largest, fastest growing, and most diverse of any museum in the country. Museum

scientists conduct groundbreaking research in fields ranging from all branches of zoology, comparative genomics, and paleontology to earth, space, and environmental

sciences and biodiversity conservation. Their work forms the basis for all the Museum’s activities that seek to explain complex issues and help people to understand

the events and processes that created and continue to shape the Earth, life and civilization on this planet, and the universe beyond.

Today more than 200 Museum scientists with internationally recognized expertise, led by 47 curators, conduct laboratory and collections—based research programs as well as fieldwork and training. Scientists in five divisions (Anthropology;

Earth, Planetary, and Space Sciences; Invertebrate Zoology; Paleontology; and

Vertebrate Zoology) are sequencing DNA and creating new computational tools to

retrace the evolutionary tree, documenting changes in the environment, making new

discoveries in the fossil record, and describing human culture in all its variety. The

Museum also conducts graduate training programs in conjunction with a host of distinguished universities, supports doctoral and postdoctoral scientists with highly

competitive research fellowships, and offers talented undergraduates an opportunity

to work with Museum scientists.

The AMNH collections of some 32 million natural specimens and cultural artifacts

are a major scientific resource, providing the foundation for the Museum’s interrelated research, education, and exhibition missions. They often include endangered

and extinct species as well as many of the only known ‘‘type specimens,’’ or examples of species by which all other finds are compared. Within the collections are

many spectacular individual collections, including the world’s most comprehensive

collections of dinosaurs; fossil mammals, Northwest Coast and Siberian cultural artifacts, North American butterflies, spiders, Australian and Chinese amphibians,

reptiles, fishes outside of their home countries, and one of the most important bird

collections. Collections such as these are historical libraries of expertly identified

and documented examples of species and artifacts, providing an irreplaceable record

of life on earth. They provide vital data for Museum scientists as well as more than

250 national and international visiting scientists each year.

In the exhibition halls AMNH scientific knowledge and discovery are translated

into three dimensions. One of the most exciting chapters in the Museum’s history

culminated just over 1 year ago with the opening of the Rose Center for Earth and

Space in February 2000. Greeted with critical and popular acclaim and record-setting attendance surpassing all projections, the Rose Center includes a rebuilt Hayden Planetarium, Hall of the Universe, and Hall of Planet Earth. It leads to the

Hall of Biodiversity, which reveals the variety of Earth’s living things and expands

the Museum’s efforts to alert the public to the critical role biodiversity plays in sustaining life as we know it. Together, the new planetarium and halls provide visitors

with a seamless educational journey from the universe’s beginnings to the formation

and processes of Earth to the extraordinary diversity of life on our planet.
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The Education Department builds on the Museum’s unique research, collections,

and exhibition resources to offer rich programming dedicated to increasing scientific

literacy, to encouraging students to pursue science and museum careers, and to providing a forum for exploring the world’s cultures. Each year hundreds of thousands

of students, teachers, and schools participate in workshops, courses for college credit, and Museum visits; more than 500,000 students and teachers come on school visits, prepared and supported by curriculum resources and workshops. The Museum

is also reaching beyond its walls: through its National Center for Science Literacy,

Education, and Technology, launched in 1997 in partnership with NASA, it is exploiting new technologies to bring learning and discovery, materials, and programs

into homes, schools, museums, and community organizations around the nation.

SUPPORT FOR DEPARTMENT OF HEALTH AND HUMAN SERVICES MISSION AND GOALS

The American Museum shares with DHHS and HRSA a fundamental commitment

to improving the nation’s health and advancing the research, training, and facilities

that support it. The Museum seeks a partnership with the agency to leverage our

complementary resources and mutually strengthen our abilities to advance shared

goals.

Genomic Science

DHHS is a leader in health-related research and genome science, advanced sequencing technologies, instrumentation, and facilities. The American Museum, in

turn, is home to a preeminent molecular research effort. Indeed, natural history and

genomic science are intricately related. The AMNH molecular systematics program

is at the forefront of comparative genomics and the analysis of DNA sequences for

evolutionary research. In its molecular laboratories, in operation now for 10 years,

more than 40 researchers in molecular systematics, conservation genetics, and developmental biology conduct genetic research on a variety of study organisms.

The Museum is also expanding its collection techniques to include the preservation of biological tissues and molecular libraries in a super-cold storage facility for

current and future genetic study. This collection is an invaluable resource for worldwide research in fields including genetics, comparative genomics, and medicine.

Such a tissue collection will preserve genetic material and gene products from rare

and endangered organisms that may become extinct before science fully exploits

their potential. With nearly 40,000 samples already collected, it will be the largest

super-cold tissue collection in the world and will increase the possibilities for DNA

research exponentially.

Parallel Cluster Computing

Parallel computing is an essential enabling technology for phylogenetic (evolutionary) analysis and intensive, efficient sampling of a wide array of study organisms.

A 256-processor cluster recently constructed in-house by Museum scientists is the

fastest parallel computing cluster in an evolutionary biology laboratory and one of

the fastest installed in a non-defense environment. It allows Museum scientists to

examine the effectiveness and computational behavior for large real-world data sets,

and will be central to all Museum projects in evolutionary and genomics research.

INSTITUTE OF COMPARATIVE GENOMICS

The Museum proposes to establish, in partnership with DHHS, an Institute of

Comparative Genomics so as to contribute its unique resources and expertise to the

nation’s genomic research enterprise. A full understanding of the impact of the

knowledge we have gained from genomics and molecular biology can come from

placing genomic data in a natural history perspective; comparative work in

genomics will enrich our knowledge not only of biodiversity, but also of humans,

medicine, and life itself. The Museum intends to establish the Institute with funds

from federal as well as nonfederal sources.

With the advent of DNA sequencing, museum collections have become critical

baseline resources for the assessment of the genetic diversity of natural populations.

Genomes, especially those of the simplest organisms, provide a window into the fundamental mechanics of life. One of the goals of the nation’s genomic science research

programs is to learn about the relevance to humans of nonhuman organisms’ DNA

sequences. This research can yield information that can be applied in solving critical

challenges in health care. The AMNH comparative genomics program could provide

vital tools in these endeavors.

The Museum has already established its parallel computing facility, enhanced the

molecular labs with state-of-the-art DNA sequencers, and built the super cold storage facility. Thus initially equipped, the Institute will be one of the world’s premier
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research facilities for mapping the genome across a comprehensive spectrum of life

forms, drawing on comparative methods and biological collections.

Working cooperatively with New York’s outstanding biomedical research and educational institutions, the Institute will focus on molecular and microbial systematics,

expanding our understanding of the evolution of life on earth through analysis of

the genomes of selected microbes and other non-human organisms, and constructing

large genomic databases for conservation biology applications. Research programs

may include the study of the utility of genomic information on organismal form and

function, microbial systematics, the construction of large genomic databases for conservation biology applications, and the use of broad scale comparative genomic studies to understand the function of important biomolecules.

The Institute’s scope of activities will include: an expansion of the molecular laboratory program that now trains dozens of graduate students every year; the utilization of the latest sequencing technologies; employment of parallel computing applications that allow scientists to examine the effectiveness and computational behavior of large real world datasets; and operation of the frozen tissue collection as a

worldwide scientific resource, with at least 500,000 samples accessioned in the first

phase alone, an active loan program, and ready public on-line access.

In addition to research, the Museum has already launched an ambitious agenda

of genomics-related exhibition, conference, and public education programming, including the landmark exhibition, ‘‘The Genomic Revolution,’’ which opens in May

2001. The exhibition, the most comprehensive ever presented on genomics, will examine the revolution taking place in molecular biology and its impact on modern

science and technology, natural history, biodiversity, and our everyday lives. In conjunction with the exhibition, the Museum may also display a video bulletin on

genomics in the Hall of Human Biology. The bulletin would be modeled after the

popular Earth, Bio, and AstroBulletins in the newest exhibit halls that display

changing science news and link to computer kiosks and websites.

In fall 2000 the Museum hosted ‘‘Sequencing the Human Genome: New Frontiers

in Science and Technology,’’ an international conference featuring leading scientists

and policymakers. Spring conferences will include: ‘‘Conservation Genetics in the

Age of Genomics,’’ co-sponsored by AMNH’s Center for Biodiversity and Conservation and the Wildlife Conservation Society; and ‘‘New Directions in Supercomputing,’’ which will explore how parallel computing can make sense of the huge complex data sets that genomic science and other fields generate. In September, the

Museum will convene ‘‘Assembling the Tree of Life: Science, Relevance, and Challenges.’’

In establishing the Institute, the Museum plans to expand its curatorial range in

microbial work; grow the super-cold tissue collection; and draw on our exhibition

and educational expertise to offer enhanced public education and outreach. Plans

entail expanding and renovating lab space and facilities to accommodate additional

curators and students. By renovating an area adjacent to one of the existing molecular labs and possibly building new space, the Museum will add lab and associated

office and maintenance space to accommodate the new Institute’s needs.

We seek $5 million in fiscal year 2002 to partner with DHHS/HRSA in establishing the Institute for Comparative Genomics at the Museum. In partnership, the

two organizations will be positioned to leverage their unparalleled resources to advance shared goals for improving the nation’s health through research and facilities,

education and training.

PREPARED STATEMENT OF THE BUSHNELL CENTER FOR THE PERFORMING ARTS

Mr. Chairman of Members of the Subcommittee, my name is Ronna Reynolds, and

I am the Interim Executive Director of The Bushnell Center for the Performing

Arts, located in Hartford, Connecticut. I am pleased to have this opportunity to

share with you the exciting and successful arts-in-education programs being conducted at The Bushnell and to urge your support for funding for additional educational programs in fiscal year 2002.

The Horace Bushnell Memorial Hall is an historic and nationally recognized performing arts center. After a $34 million renovation and expansion project, the 71-

year-old Hall has been renamed ‘‘The Bushnell Center for the Performing Arts.’’ We

believe it’s an appropriate name to describe a center for the arts, a center for the

community, and a center for education that will all come together—and bring people

together—at The Bushnell.

The new Bushnell is more than just a building. It is a facility that will enhance

Hartford’s position as a premier performing arts destination. The 90,000 square-foot

facility being built adjacent to the current Mortensen Hall will include the Belding
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Theater, a Great Hall for receptions and smaller performances, and such amenities

as a cafe ́, gift shop, classroom space and more rest rooms and elevators. With the

current Hall booked to capacity, the expansion will enable The Bushnell to present

new arts and entertainment options and better accommodate local arts organizations in multiple performance spaces. It will also give an economic boost by bringing

more people to downtown Hartford.

The new Bushnell facility presents the opportunity to link the Hall’s artistic programming to education and learning. For most of the 20th Century, education and

serving the community has been the central focus for The Bushnell as it has dedicated considerable resources and leadership to create powerful tools for learning and

building community. Our educational programs serve as the stable and sustainable

base from which The Bushnell can continue to expand and deepen its education,

community service and programming. The result is a performing arts center which

serves as a classroom without walls; a stage ‘‘in and of’’ the community.

The strongest and most visible manifestation of this commitment can be found in

the The Bushnell’s arts education programs. The Bushnell Center for Learning is

the organization-wide structure through which The Bushnell will promote and cause

the arts to advance education in communities and schools through direct services,

training, advocacy, and convening. This new Center represents a coalescing of all

educational activities of The Bushnell under one umbrella. With a focus on direct

services through classroom programs, teacher and artist training, public policy and

advocacy and community and educational convener, The Bushnell Center for Learning places educational programming as central to the organization’s day-to-day activities.

Several programs comprise The Bushnell Center for Learning, including direct

services and programs for grade school and high school students, as well as training

programs and teaching seminars. The Bushnell has over ten years of experience operating arts-in-education programs that use the arts to improve literacy and to increase the understanding of diverse cultures for over 6,000 public school students

in four school districts in Connecticut.

THE PARTNERS PROGRAM

PARTNERS (Partners in Arts and Education Revitalizing Schools) is a nationally

recognized arts-in-education program that strengthens language arts skills and fosters multi-cultural competence in the Hartford area schools. Implemented in 1993

in eight schools in Hartford, West Hartford and Bloomfield, PARTNERS uses the

visual and performing arts to spark learning and generate excitement in the classroom. Participating in the program provides not only a foundation for artistic literacy, but more importantly, it strengthens the core educational curriculum while

bringing together a great diversity of students in a unique educational experience.

Since 1996, PARTNERS has been active in the Plainville Community Schools in

partnership with GE Fund of Fairfield and GE Industrial Systems of Plainville.

The PARTNERS program is made up of five interlocking components: curriculum

and assessment, artistic resources, staff development, The Bushnell Children’s Theatre and family events. Curriculum and assessment are at the core of all PARTNERS program components. Curriculum resources ensure that cross-cultural,

hands-on arts experiences are integrated into a child’s classroom experience through

multi-cultural children’s literature, book-based activity guides, and other pertinent

materials. Program assessment has been carried out each year in an attempt to review and test program components and the goals set forth in the initial program

design.

In the PARTNERS program, professional artists take on the role of teaching artists who develop and lead classroom-based arts activities. Presenting artists who

conduct grade level assembly presentation further students’ understanding of these

areas through performances delivered at the school site. Classroom and performance

experiences are also enriched by museum, theatre, and science center field trips

throughout the year. Through the professional development component, PARTNERS

provides participating classroom, art and music teachers with exposure and handson access to the arts-integrated units of study. These sessions, held at The Bushnell,

offer educators the opportunity to use the arts as tools to enhance the learning process for their students.

OTHER EDUCATIONAL PROGRAMS

In addition to the PARTNERS program, The Bushnell offers other educational

programs and services, including:

—Professional development and support services to educators, artists, contributors, and organizations;
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—Replication and dissemination of the PARTNERS technique and curriculum

through building the capacities of institutions, communities and schools; and

—Integration of programming and education through a collaborative planning

process and marketing strategy to be known as ‘‘Great Works’’.

These combined activities enrich the lives of students who are involved in the

many different Bushnell educational programs, including:

—Living Laboratories in Schools

—Parent Enpowerment through Early Literacy and Read Aloud

—The Bushnell Children’s Theatre

—Pre and post performance lectures

—Arts camps

—High School lecture series

—Teachers institutes and seminars and other professional development programs

—Artist training

Mr. Chairman, in order to support the expansion of arts-in-education programs

at The Bushnell Center for Learning, we respectfully request $1 million through the

Department of Education’s Fund for the Improvement of Education (FIE) account

in the Fiscal 2002 Labor/HHS/Education Appropriations bill. Thank you for your attention to this request, and for your support of programs which benefit the children

of Connecticut and children across the nation.

PREPARED STATEMENT OF THE AMERICAN COUNCIL ON EDUCATION COALITION FOR

INTERNATIONAL EDUCATION

Mr. Chairman and Members of the Subcommittee: We are pleased to have the opportunity to present the views of the Coalition for International Education on the

fiscal year 2002 appropriations for the Higher Education Act, Title VI and the Mutual Educational and Cultural Exchange Act, Section 102(b)(6), commonly known as

Fulbright-Hays. The Coalition for International Education is an ad hoc group of 28

national higher education organizations with principal focus on the aforementioned

international education, foreign language and exchange programs. Together they

represent the nation’s 3,300 colleges and universities, and numerous disciplinary,

international exchange groups and other international education organizations.

Over the history of Title VI and Fulbright-Hays, many different groups have come

to the Federal Government to make their case for these programs. This usually has

taken the form of small coalitions or separate voices arguing for their particular interests. However, the sense of urgency about the United States’ declining international competence against a backdrop of enormous international challenges is so

strong within the higher education community, that it has drawn our different perspectives into a single consensus position.

We express our appreciation for the Subcommittee’s support for these programs.

Title VI has grown over the last decade, and Fulbright-Hays in the last year.

To address new and expanding challenges to the nation’s leadership capabilities

in foreign policy, national security, economic competitiveness, and solving global

problems, the Coalition recommends a 3-year strategic plan for Title VI and Fulbright-Hays. The plan proposes increasing the number of experts with in-depth

international knowledge and highly proficient foreign language skills, as well as the

number of U.S. citizens with global competence. Our proposed funding levels for fiscal year 2002, more fully described below, would be the first installment of this

plan.

PROGRAM OVERVIEW

At the height of the Cold War, Congress created Title VI in the National Defense

Education Act of 1958, and Section 102 (b)(6) of the Mutual Educational and Cultural Exchange Act of 1961 out of a sense of crisis about U.S. ignorance of other

countries and cultures. Spanning more than four decades, these programs still remain the Federal Government’s most comprehensive mechanisms for supporting the

development and maintenance of a higher education infrastructure that produces

the nation’s expertise in foreign languages, and area and other international studies, including international business. The programs have grown and evolved over

this time in response to the changing global environment. The fourteen funded Title

VI and Fulbright-Hays programs support activities to improve our educational capabilities, from K–12 through the graduate levels and advanced research, with emphasis on the less commonly-taught languages and areas of the world. Title VI largely

supports the domestic side of training and research, while Fulbright-Hays supports

an essential overseas component.
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FEDERAL ROLE

The Federal Government plays a critical role in international and foreign language education because of the clear relevance of international competence to the

conduct of U.S. foreign policy, to the national security of the U.S., and to the health

and vitality of the U.S. economy in a global marketplace. Informed decisions in

these areas by public and private sectors depend on citizens who have the skills and

understanding of other nations’ languages, cultures and systems to function effectively within them. U.S. global leadership depends on persons who know how the

people of other cultures think and work and who can competently assess the political, economic, or social implications of decisions and actions. In short, it is a critical

federal role to ensure the nation is successfully prepared to respond to the challenges presented by its relationships with other nations.

Through Title VI and Fulbright-Hays programs, the Federal Government shares

this responsibility with institutions of higher education, in partnership with the corporate and state/local government sectors. State and local governments and the private sector, including foundations, will not by themselves focus on long-term national needs for international expertise. While these sectors support short-term

projects from time to time, they do not provide the long-term, sustained support for

the 10–12 years of study and research needed to produce an expert on the Middle

East fluent in Arabic, for example. Moreover, universities could not bear this responsibility alone. Outside resources are essential incentives for developing and sustaining interdisciplinary programs, underwriting high cost programs in the less

common-taught languages and areas, and providing extensive outreach and collaboration among education institutions, government agencies, and corporations.

EXPANDING NATIONAL NEEDS

There is fresh evidence that the nation’s needs for international competence continue to expand in the global era, and that the government, corporate and education

sectors face a dangerously short supply of qualified personnel.

Responding to new demands to protect national security in a broad range of arenas throughout the U.S. and the world, virtually every federal agency now is engaged globally. One estimate is that over 80 federal agencies and offices rely on

human resources with foreign language proficiency and international knowledge and

experience. Hearings last fall of the Senate Subcommittee on International Security,

Proliferation, and Federal Services revealed the shortage of personnel with the foreign language and area skills required to meet national security needs across the

defense, intelligence, and foreign policy agencies. These agencies report shortfalls in

hiring, deficits in readiness, and adverse impacts on operations. One federal agency

estimated its total needs to be 30,000 employees dealing with over 80 languages,

while another identified key shortfalls in Central Eurasian, East Asian, and Middle

Eastern languages.

Title VI and Fulbright-Hays are among the few programs the Federal Government supports that provide the necessary long-term investment in building the language and foreign area capacity that responds to national strategic requirements.

Regional expertise and language ability related to less commonly-taught areas are

offered primarily through higher education institutions receiving Title VI funding.

In fact, a recent study funded by the U.S. Department of Education revealed that

81 percent of the graduate language enrollments in the least commonly taught languages are located at Title VI-funded institutions. Because of the high cost per student, these programs would not exist without Title VI support.

National security is increasingly linked to commerce, and U.S. business is widely

engaged around the world with joint ventures, partnerships, and economic linkages

that require its employees to have international expertise both at home and abroad.

A recent study on the internationalization of American business education found

that knowledge of other cultures, cross-cultural communications skills, experience in

international business, and fluency in a foreign language ranked among the top

skills sought by corporations involved in international business. Despite new efforts

to internationalize business education in the last decade, U.S. business schools continue to fall short of fulfilling the need of businesses for personnel who can think

and act in a global context.

Title VI supports important programs that internationalize business education

and help small and medium-sized U.S. businesses access emerging markets, a boost

toward reducing the trade deficit and creating U.S. jobs. The U.S. Department of

Commerce reports that 97 percent of all U.S. export growth in the 1990s was contributed by small and medium-sized companies, and yet only 10 percent of these

companies are exporting. The most common reason cited by U.S. businesses for not
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pursuing export opportunities is a lack of knowledge and understanding of how to

function in the global business environment.

In addition to business, the ubiquitous nature of globalization also is driving new

demands for globally competent citizens and international knowledge in almost all

fields of endeavor, such as health, the environment, and law. Whether it be in the

culturally diverse U.S. workplace or on assignment abroad, employers increasingly

look for candidates who have cross-cultural skills, foreign language proficiency, and

the ability to meet the international challenges of their field. Increasing the pool of

underrepresented minorities who pursue international careers is a critical dimension as well.

Title VI and Fulbright-Hays programs support projects to infuse foreign language,

area and other international studies into the curriculum and across disciplines, from

K–12 through professional education. They support increasing the capacity of predominantly minority-serving institutions to produce globally competent graduates

who enter the international service. Extensive outreach programs serve government,

education and corporate needs for international knowledge.

Finally, it does not appear that our education system is positioned to produce the

increasing numbers of international experts needed, or even ordinary citizens who

are globally competent. Recent studies and surveys suggest that overall our education institutions are falling behind in international education:

—The vast majority of students is being provided with only rudimentary levels

of international skills and competencies;

—Foreign language enrollments in United States higher education fell from 16

percent in 1960 to just 8 percent today and the number of 4-year colleges with

foreign language entrance and graduation requirements also declined. On the

positive side, foreign language enrollments in community colleges and at the K–

12 levels are increasing;

—There is a shortage of trained teachers and faculty in foreign languages, especially the less commonly-taught languages, and in area and international studies; and

—Only about 3 percent of United States students enrolled in United States colleges and universities study abroad.

Title VI and Fulbright-Hays programs support the training of teachers and faculty

in foreign languages and international education. They support overseas research,

the development of study abroad programs in underrepresented areas, research in

the teaching and learning of foreign languages, and the application of new technologies to all of these efforts.

FISCAL YEAR 2002 FUNDING PROPOSAL

Funding for this account during President Clinton’s Administration did not keep

up with increased national needs for global competence or with increases in overall

federal education funding. When adjusted for inflation, the Department of Education’s budget for discretionary programs grew by about 50 percent since fiscal year

1994, while these programs combined increased by only 14 percent. Despite the increase, Title VI and Fulbright-Hays continue to be funded below their constant dollar level of the late 1960s. (For example, only half as many Foreign Language and

Area Studies fellowships are being awarded today, compared with fiscal year 1967.)

Moreover, funding for the Institute for International Public Policy has not been increased since its inception in fiscal year 1994.

Our 3-year strategic plan proposes three policy goals to meet the growing national

needs described above:

—Increase the production of the nation’s international expertise and knowledge

to meet national strategic needs;

—Enhance the knowledge and skills of our citizens for a global workplace; and

—Expand education, government and private sector access to international expertise and knowledge (outreach and dissemination)

To address these goals, we recommend as a first year installment, a total of

$96.32 million for the International Education and Foreign Languages Studies account. This represents an $18.3 million increase over fiscal year 2001.

We recommend our proposed increase be allocated as follows:

—A $13.5 million increase in Title VI–A & B domestic programs ($80.5 million

in total). Title VI–A & B programs ensure a national capacity of expertise and

knowledge in foreign languages, area and other international studies, including

international business education. The proposed increase would strengthen activities addressing national strategic needs and shortfalls in capacity: (1) training the next generation of experts and producing research on the foreign languages, world areas and global/regional issues of emerging economic and secu-
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rity importance; (2) infusing foreign languages and area studies into the professional disciplines; (3) increasing outreach and linkage activities to government

agencies, business, the media, and education institutions; (4) accessing and

making widely available expensive foreign information resources using innovative applications of technology; and (5) enhancing the knowledge, understanding

and skills of our citizens for a global workplace. —A $3.3 million increase in Fulbright-Hays ($13.3 million in total). FulbrightHays complements Title VI programs by providing U.S. students, faculty and

teachers a vital overseas research and training dimension in foreign languages

and area studies. For example, in a recent survey of former doctoral dissertation

research abroad grantees, nearly all indicated they could not have achieved

their level of expertise without this support, and that they utilized the skills

gained abroad in teaching and research. Yet under this program in fiscal year

2000, only 88 fellowships could be awarded out of an applicant pool of 417. In

recent years the average number of fundable applications for all four Fulbright

programs has been roughly double the number actually awarded with available

funds. An additional $3.3 million would enable about 75 more awards for doctoral dissertation, faculty research, group projects and seminars abroad. —A $1.5 million increase for the Title VI–C Institute for International Public Policy ($2.52 million in total). The IIPP responds to the national need for a diverse

pool of well-trained, language-proficient professionals to enter the foreign service and related careers. Students completing this program have earned the distinction of passing the foreign service oral exam on the first attempt. Level

funding for the IIPP since fiscal year 1994 has caused a scaling back of several

program components. An additional $1.5 million will enable full funding of the

graduate fellowships and reinstatement of the institutional capacity—building

grants to HBCUs, HSIs, and other minority institutions, in keeping with the

program’s statutory mandate.

We consider our request to be a modest one for programs vital to our nation’s

long-term security and economic well being. Thank you for your consideration and

for the opportunity to express our views.

PREPARED STATEMENT OF THE COLONIAL WILLIAMSBURG FOUNDATION

Dear Mr. Chairman: Colonial Williamsburg Foundation hereby submits for the

record, testimony regarding an electronic field trip project called the ‘‘Outreach Education Initiative.’’

SUMMARY

Colonial Williamsburg, the nation’s oldest and largest living history museum, continues to inspire Americans. Our national history is a dramatic story that continues

to influence the present. The story of America’s colonial history and the coming of

the American Revolution are the heritage of every American. Colonial Williamsburg

explores the history behind the critical issues that still challenge American society—

how diverse people, holding different and sometimes conflicting personal ambitions,

evolved into a union that valued both liberty and equality.

This history that defines us as a nation should be understood by all school children. Technology is the means by which this message can be clearly delivered to

schools across America.

Each year, one million adults and children from all fifty states and several foreign

countries, visit Colonial Williamsburg’s Historic Area in person, including over

160,000 students on school study trips.

For most students, however, a personal visit to the Historic Area is not a realistic

option.

To reach students and teachers throughout the country, Colonial Williamsburg

launched its Educational Outreach Initiative with the electronic field trip project in

the fall of 1996. This initiative takes the museum’s dynamic methods of history education beyond the streets and buildings of Williamsburg and transports them directly into the nation’s classrooms. Electronic field trips replicate, to the greatest extent possible, an actual visit to Colonial Williamsburg and create a palpable excitement for learning.

With the best technological communication resources at our command, Colonial

Williamsburg reaches millions of students and teachers throughout the country.

Through electronic field trips, this experience is taken directly to the nation’s classrooms. These programs currently reach an estimated one million registered students

in forty-six States with a total viewing audience of more than five million unregistered students and home viewers.
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Colonial Williamsburg’s Electronic Field Trips—‘‘lightspeed learning’’ experiences—are live, interactive television programs, linked to comprehensive teacher’s

guides, and Internet activities and discussion groups. Several weeks before each program airs, registered schools receive a teacher’s packet, which includes an instructional videotape and short introduction to Colonial Williamsburg, a comprehensive

teacher’s guide, full-color classroom poster, and links to national standards of learning. The teacher’s guide includes historical background materials, facsimiles of historical documents and prints, photographs of Colonial Williamsburg and its costumed interpreters, glossaries, timelines, and several suggested lesson plans written

by classroom teachers.

Electronic field trips are eight live broadcast events each school year. Each field

trip consists of two or three historical dramas depicting aspects of eighteenth-century life, ranging from a young recruit’s view of military preparations for the Revolution to a free black man’s efforts to buy his wife’s and children’s freedom from

their owner.

After each dramatic vignette, students from registered schools can speak directly

to the historical interpreters on live television, asking questions and expressing

opinions about the issues presented in the programs. Those students that do not

make it on air can speak via the telephone and the Internet to more than thirty

interpreters and historians behind the scenes. During an electronic field trip, Colonial Williamsburg staff will respond to over 1,300 phone calls in four hours and

reply to as many as 1,000 email and Internet bulletin board inquiries. Students can

also vote on issues raised during the program to see how their votes compare with

others across the country.

The field trips are also much more than history lessons. History is just a starting

point for high-tech interdisciplinary learning in civics, mathematics, science, art,

and government, and an excellent venue for honing critical thinking skills—so necessary for creating a job-ready work force.

Through the electronic field trips Colonial Williamsburg is able to teach our country’s history and encourage the use of technology in the classroom for a wider audience. Here’s what one California teacher had to say about the impact of an electronic field trip on her classroom and on one ‘‘at-risk’’ student in particular:

‘‘One of my boys, who is an at-risk student and who has had lots of problems,

was able to get on the air with his question and was so excited! He was the fifth

grade star because the other fifth grade classes were also watching the program to

hear his question.... The kids are now primed for our study of the American

Revolution.’’——Sally White, Teacher, George White Elementary School, Laguna

Niguel, California

AUDIENCE SERVED

The target audience for Colonial Williamsburg’s electronic field trips includes the

nation’s entire student population, generally students from fourth through twelfth

grade.

Extrapolating information from registered schools and the number of students

asking questions and voting via telephone and the Internet, Colonial Williamsburg

estimates that at least 500,000 registered students actively participated in the

1996–1997 electronic field trips. Current estimates predict that approximately 1 million registered students will have participated in the 1999–2000 electronic field

trips, with a total viewing audience of more than 5 million.

Communities across the country are concerned about studies showing the erosion

of young people’s American history knowledge and the need for teacher and student

training in the use of educational technology. Last year Congress made additional

funds available for history education programs. Colonial Williamsburg’s electronic

field trips are an important contribution to improving history education and helping

students become more knowledgeable and excited about the past while relating it

to their current environment.

Electronic field trips help students discover positive role models from history to

which all young people, from gifted to at-risk students, can relate. They increase

teacher familiarity with technology and their understanding of appropriate methods

for utilizing it. These programs are standards—based in multiple disciplines, providing opportunities to engage students in cross-discipline learning. They are very

low cost and accessible through almost any level of technology available to the classrooms. In addition, Colonial Williamsburg staff members work with teachers independently to help them get the most out of the programs.

Colonial Williamsburg’s electronic field trips provide opportunities to integrate

technology in the classroom and enhance technical skills. Teachers and students in
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less-advantaged communities might have access to communication hardware but

don’t have the training to use those technology resources. Because information tools

and familiarity in using them are increasingly important to individual success, it

is essential to correct this imbalance. Technical competence is integral to the success

of today’s students and tomorrow’s adults and, without such competence, a large

portion of the nation’s citizens will be left behind, unable to compete, and increasingly distanced from the means by which many people are receiving information,

producing work, and participating in their communities.

METHODS

Begun in the fall of 1996, Colonial Williamsburg’s Electronic Field Trips craft

comprehensive teacher materials, live interactive broadcasts, and Internet activities

into an interactive learning experience for students. Each field trip follows a similar

format combining production, educational material, and new media components.

Production

The main component of each field trip is a live, one-hour, interactive broadcast,

offered twice on the broadcast day so that students in all United States time zones

can participate. Each program is of broadcast quality and is sent via satellite, as

well as via public and educational broadcasters, to schools across the United States.

Colonial Williamsburg historical interpreters host each program, introduce students to life in colonial America, and are available for questions from registered

viewers.

Interaction—the exchange of ideas and opinions—is the heart of a Colonial Williamsburg electronic field trip. The intent is to make students feel as if they have

traveled back to the eighteenth century and are active participants in the process

of history. Based on the responses from teachers and students, this format works

extraordinarily well.

Traditional Educational Material

The teacher’s guide includes historical background materials, facsimiles of historical documents and prints, photographs of Colonial Williamsburg and its costumed

interpreters, and several suggested lesson plans. Colonial Williamsburg’s teacher

advisors develop these teacher guides and lesson plans. Because classroom teachers

create them, they are practical and useful. Feedback from educators indicates that

the teacher’s guides are excellent resources, particularly the primary source documents, which are often difficult for educators to find.

Media Components

The Internet component of the field trips provides another venue for the students

to engage in interactive, distance learning. Each field trip provides a forum that allows students to discuss issues and ask questions of each other and of Colonial Williamsburg’s historians. The forum remains available throughout the school year so

those educators who wish to revisit the material later in the school year can still

interact with Colonial Williamsburg. Also, the teacher’s guide is available on-line

along with several participatory student activities. Student on-line activities provide

an opportunity to explore topics in-depth, and to extend and amplify the classroom

and broadcast lessons.

PROJECT NEED

Colonial Williamsburg believes that Thomas Jefferson was correct: an educated

populace is essential for the maintenance of a free democracy. The fundamental

premise of our government is that political power derives from the informed consent

of the people, which, we believe, can come only from knowledge and understanding

of the people and events that shaped American society. Through historical knowledge, Americans come to appreciate their pluralistic society and see other racial,

ethnic, and religious groups as part of the nation’s genius and strength. An understanding of the principles on which this country was founded is indispensable in the

development of an informed citizenry. Furthermore, the study of history promotes

the critical thinking skills that are so necessary for a job-ready work force.

An increasingly disturbing portrait of American education is emerging from research on schools; parents and educators alike are concerned about students’ lack

of knowledge and preparation. Often, in the efforts to address deficiencies in language arts and math skills, history is virtually left out of the curriculum. Many elementary school teachers do not receive enough exposure to the subject during their

classroom training. Students who can keep pace with state-of-the-art computer technology may find little to capture their imagination in events that took place decades
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or centuries ago. As a result, youngsters simply do not form a basic understanding

of American history and, therefore, are not interested in the subject.

Schools nationwide are finding that resolving the crisis in education calls for a

new pedagogy. Many schools, particularly those that and present the classic profile

of a student population at risk, are struggling to make instruction both meaningful

and effective and fun.

The confluence of several successful Colonial Williamsburg programs and the

needs of the schools suggests that now is the time to create a comprehensive program targeting both teachers and students in our nation’s school system and promote a renewal of history education.

REQUEST

While Colonial Williamsburg currently reaches over one million registered students with innovative, state-of-the-art programs, we feel we have an obligation to

help more schools and students better understand the history of our nation. Recently, Colonial Williamsburg received a private donation of $5 million to endow the

Electronic Field Trip programming.

As stewards of an important segment of our American heritage, we are asking for a one-time appropriation of $5 million to leverage with the $5 million private endowment. Federal money would allow Colonial Williamsburg to do the following:

—Support distribution of the video program across the country.

—Support the further development of web casting.

—Support coordination with the various state standards of learning.

—Support disadvantaged schools to integrate technology and education in their

schools.

The Colonial Williamsburg Foundation wishes to express its deep appreciation to

this Committee for permitting us to submit this presentation on the ‘‘Outreach Education Initiative.’’ Your positive response for Colonial Williamsburg’s request for

support will have a positive impact on our nation’s education crisis by teaching history to our children.

PREPARED STATEMENT OF FLORIDA STATE UNIVERSITY

Mr. Chairman, I would like to thank you and the Members of the Subcommittee

for this opportunity to present testimony before this Committee. I would like to take

a moment to briefly acquaint you with Florida State University.

Located in Tallahassee, the capitol of Florida, FSU is a comprehensive Research

I university with a rapidly growing research base. The University serves as a center

for advanced graduate and professional studies, exemplary research and top quality

undergraduate programs. Faculty members at FSU maintain a strong commitment

to quality in teaching, to performance of research and creative activities and have

a strong commitment to public service. Among the faculty are numerous recipients

of national and international honors, including Nobel laureates, Pulitzer Prize winners as well as several members of the National Academy of Sciences. Our scientists

and engineers do excellent research, have strong interdisciplinary interests, and

often work closely with industrial partners in the commercialization of the results

of their research. Having been designated as a Carnegie Research I University several years ago, Florida State University currently is approaching $125 million per

year in research awards.

Florida State attracts students from every county in Florida, every state in the

nation, and more than 100 foreign countries. The University is committed to high

admission standards that ensure quality in its student body, which currently includes some 192 National Merit and National Achievement scholars, as well as students with superior creative talent. We consistently rank in the top 25 among U.S.

colleges and universities in attracting National Merit Scholars to our campus.

At Florida State University, we are very proud of our successes as well as our

emerging reputation as one of the nation’s top public universities.

Mr. Chairman, let me tell you about a project we are pursuing this year involving

the U.S. Department of Education and distance learning. Florida State University

is pioneering the use of distance education to provide access to baccalaureate degrees for students with Associate of Arts degrees who, due to family or work situations, may not be able to relocate to a college or university to complete their degree

work. FSU is currently offering upper-division programs entirely online for students

to receive their baccalaureate degree in Computer Science, Information Studies, and

Software Engineering—all areas central to our economy. An essential part of this

program is the use of mentors, who take a proactive stance toward the students,

contacting them on a regular basis to provide assistance, and are available electroni-
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cally to students as needed. Student mentoring is key to insuring successful outcomes in distance courses.

This program is a model of effective distance learning that can be used anywhere

at the undergraduate level. Our focus has been on Florida, though we have a small

number of out-of-state students in our distance degree programs. With additional

support, additional majors can be added and the program can be expanded to serve

a wider range of students geographically. Front-end development activities are essential for quality courses and require significant expenditures to add majors, train

mentors and offer degree programs on a larger scale.

Additionally this year, we plan to address the issue of preparing students to become K–12 teachers. Governor Bush has stated that he would like to see teachers

trained both by traditional and alternative means and wants skills of current teachers to include the use of technology. We will utilize the same articulation we have

between the AA and the bachelor’s degree in Florida to offer first the general teacher certification courses online, then begin placing specific areas of certification online. In addition, we plan to build on our ‘‘Troop-to-Teachers’’ project and have a robust alternative certification program available online. Many qualified people in

mid-life or retires who may want to become teachers are discouraged by the typical

format for teacher certification which requires then to return to a campus to take

undergraduate courses. The state of Florida is pioneering with an alternative certification program that allows the local school board to certify teacher if they go

through a process while employed at the school. Florida State has take the first

steps in developing an online curriculum for alternative certification that could be

used by any of Florida’s 67 school districts, and for that matter anywhere else in

the country where the alternative certification model is employed. It is being piloted

in two school districts this year. We will service students in Florida and will expand

to draw students from other states that plan to relocate to Florida. Further, this

can serve as a demonstration project which if successful could be adopted across the

nation to help alleviate our teacher shortage. We will do this with the guidance of

the recent reports—the first, Investing in Teaching, which was prepared by a consortium composed of The Business Roundtable, the National Alliance of Business,

the National Association of Manufactures, and the US Chamber of Commerce. The

other report, Professional Standards for the Accreditation of Schools, Colleges and

Departments of Education, has been published by the National Council for Accreditation of Teacher Education (NCATE).

Florida State University is heavily invested in new technologies and learning and

is ideally positioned to provide further leadership in student supported high quality

distance learning. Last year, FSU received $170,000 in fiscal year 2001 to begin its

efforts. We are seeking an appropriation of $3 million within the Department of

Education’s Fund for the Improvement of Post-Secondary Education account to continue and expand this activity in fiscal year 2002.

Finally Mr. Chairman, I would like to discuss construction needs of the FSU College of Medicine. Last year, the State of Florida approved the establishment a Medical School at Florida State University. The FSU College of Medicine is the first

medical school to be established in the United States in a quarter of a century. This

initiative is a major opportunity for FSU and will be a tremendous asset to the

State of Florida. By establishing this medical education program in a unique fashion, which is our plan, we are convinced that its creation can have a national impact

on medical education. The University is seeking to implement this new approach to

medical education in extremely innovative and nontraditional ways, and we will be

doing so in an efficient fashion that will meet today’s and tomorrow’s challenges to

the practice of primary care matched with Florida’s unique demographics. The College’s focus will not be on centralized campus clinical care facilities. We intend to

maximize the University’s statewide visibility to create networks of collaborative relationships with public health clinics, hospitals, and other primary health care delivery systems throughout the State. We will employ approaches that include unique

and extensive distance learning technologies, telecommunications and telemedicine

capabilities; we will focus on public, community, and rural health; we will develop

expertise and interest in health policy issues, health statistics, and demographic research; we will focus on an aging population; and we will emphasize health professions development. The University will build upon existing strengths in many of

these areas to create a truly unique medical resource of the State of Florida and

the nation.

Florida State University has already received $30 million from the Florida legislature over the past two years for a new basic sciences building to be used for the

College of Medicine. There is another $15 million requested in Governor Bush’s

budget pending with the legislature at this time. The estimated cost of the medical

building is $60 million. We are requesting the remaining funding, $15 million, to
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be secured from HRSA, which will allow us move forward with the building of this

facility, and will ultimately allow FSU’s new College of Medicine to becomes a reality. This investment will have lasting results that will greatly benefit both Florida

and the nation.

Mr. Chairman, these are just a few of the many exciting activities going on at

Florida State University that will make important contributions to solving some key

problems and concerns our Nation faces today. Your support would be appreciated,

and, again, thank you for an opportunity to present these views for your consideration.

PREPARED STATEMENT OF THE NATIONAL MILITARY FAMILY ASSOCIATION, INC.

Mr. Chairman, the National Military Family Association and the families we represent are grateful to this Subcommittee and to the United States Senate for its actions on behalf of military children and the Impact Aid Program. We thank all Congressional supporters of Impact Aid, especially the Members of the House and Senate Impact Aid Coalitions, for securing another increased appropriation for the program for fiscal year 2001. Your continued support of this program translates into

better education for approximately 550,000 military children and several million of

their civilian classmates in school districts across the country.

THE MILITARY CHILD

NMFA presents this statement on behalf of military families, or more specifically

on behalf of military children:

—Military families move an average of every 2.9 years, three times the rate of

their civilian counterparts. Military children attend an average of six different

schools during their K–12 education. Less than 20 percent of these children attend Department of Defense schools; the overwhelming majority of military children attend civilian schools dependent on Impact Aid.

—Military children bring a wealth of cultural experiences gained from living in

many parts of the world to their new schools. They also frequently come with

gaps in their education that their new teachers must quickly fill while moving

the rest of the class ahead. Sometimes they are far ahead of their new classmates, adding boredom to the list of reasons why they hate moving to yet another new school.

—Because of varying course standards, school schedules, and state graduation requirements, military children sometimes lose credits needed for graduation.

Currently 18 states have graduation requirements linked to performance on

state exit exams; 6 more states are developing exit exams. With the rise of exit

exams and increased graduation requirements, transfers in the last year or two

of high school are becoming more problematic. A change of schools at any time

is traumatic, but a change in the middle of the school year is especially so. A

midyear transfer can place some children so far behind that they cannot catch

up the rest of the school year.

—Because of the high operations tempo of today’s military, the military child

often has to adjust to the new school, face that week of standardized tests, fight

for the spot on the newspaper staff, and play the basketball game before a

crowd of strangers, all without the support of their military parent. Worry

about the safety of a parent in a place far from home where people are shooting

at each other makes for a powerful distraction from the business of education.

Today’s military force is an educated force and military members have high expectations for their children’s education. More are accepting or rejecting assignments,

or even deciding to leave the military, based on perceptions about the quality of education their children will receive at prospective duty stations.

WHY IMPACT AID? THE FEDERAL RESPONSIBILITY

Military families understand that the Impact Aid program supports basic education services provided by their local school districts. They understand the impact

the federal presence has on the tax base of these local districts and their states.

They understand the impact their children and the transient military lifestyle can

have on their local schools. What they do not understand is that Impact Aid funds

fall short of the levels intended by the creators of the program or of the amount

needed by their children’s schools.

Military families hold the Government, and the citizens they have sworn to serve

and protect, accountable for living up to their promise to provide a quality education

for their children. The districts have accepted the responsibility to educate military
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children; the Federal Government must provide the resources it has promised to

support that education. The intent of the original Impact Aid legislation (Public Law

81–874) was ‘‘to provide financial assistance for those local educational agencies

upon which the United States has placed the financial burden.’’ It originally provided an ‘‘in-lieu-of-tax’’ payment equal to the local per-pupil costs for students

whose military parent both lived and worked on a federal installation (these students were termed ‘‘military A’’ students) and one-half of the local per-pupil cost for

students whose military parent worked on a federal installation but lived in the civilian community (termed ‘‘military B’’ students).

NMFA thanks this Subcommittee and the Congress for its continued funding of

Impact Aid for the military children who live off the installation, the military Bs.

Two-thirds of military families live off-base. Although military families living in the

civilian community pay property taxes to help support local schools, they often do

not contribute to other sources of education funding. States provide an increasingly

larger share of local districts’ funding. Many military members pay no state tax on

their military income. They also shop in military exchanges and commissaries, thus

paying no sales tax. Under the provisions of the Soldiers’ and Sailors’ Relief Act,

they are often exempt from paying personal property taxes or license fees for automobiles if they are on military orders away from their home state. Military children,

whether living on- or off-base, impose costs on the district as they move in and out:

records must be prepared, evaluations and testing must be done for special programs, transition labs or remedial programs may be needed.

NMFA is grateful to the Congress for recognizing the costs imposed on school districts by the military B students and the inadequacy of the B’s weighting at only

one-tenth of the payment made for on-base students. The increased weight to twotenths of the on-base payment included in last year’s reauthorization of the Impact

Aid program was an important step in providing districts that serve these children

with the funding necessary to meet their responsibility for educating them. Funding

for these children will become even more crucial for school districts as the military

Services increasingly look to the civilian community to provide more housing for

military families. Funding for military Bs will also be important to districts serving

installations building privatized housing in civilian communities off-base rather

than on the installations. Although developers may be paying some taxes, these revenues may be inadequate, especially during the early years of the privatization contracts.

The administration’s fiscal year 2002 budget proposal included a request for Impact Aid basic support at the fiscal year 2001 funding level rather than the smaller

request we had come to expect from previous administrations. We note, however,

that the increased weight now provided for off-base students will result in smaller

payments for some districts unless more money is provided for basic support. We

would hate to see that a much-needed change to help districts educating many offbase children would be paid for by districts supporting large numbers of on-base

military children.

A well-funded Impact Aid program enables districts serving large numbers of military children to approach the level of educational opportunity available in neighboring, non-impacted school districts even though they do not have access to the

same kind of tax base. Impact Aid dollars are targeted to districts where the Federal responsibility is the greatest under the law. The dollars go directly to school

districts with no strings attached. The local community, the people with the greatest

stake in the quality of education in their schools, decides how Impact Aid funds will

best serve the basic education needs of all students.

FAMILY HOUSING PRIVATIZATION: A CAUTIONARY NOTE ON EDUCATION FUNDING

NMFA has supported the concept of privatization of military family housing as

essential for increasing the amount of capital available to eliminate the backlog in

substandard housing. However, we caution installation leaders and wish to inform

policymakers of privatization’s unintended consequences on both family budgets and

school district funding. The law requires that servicemembers living in privatized

housing be paid Basic Allowance for Housing (BAH), which is then turned over to

the developer as rent. Eligibility for safety net programs administered by the U.S.

Department of Agriculture such as food stamps; the Women, Infants, and Children

(WIC) nutrition program; and free and reduced price school lunches is based on a

family’s total income. When an installation’s housing is privatized and servicemembers start receiving BAH—which is immediately passed to the developer via

an allotment—the total income as indicated on the member’s Leave and Earnings

Statement (LES) seems to have increased. Many servicemembers then lose eligibility for safety net programs. Press reports state, for example, that two-thirds of
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the families receiving food stamps on Fort Carson, CO, lost their eligibility once the

housing was privatized. When families lose eligibility for free and reduced school

lunches, their local school can also lose other funding. Federal Title 1 and E-rate

technology funding as well as some state funding is based on a school’s poverty rate,

which in turn is based on the percentage of children receiving free and reduced

lunches. Fountain-Fort Carson District 8, a district of approximately 4,900 children,

reports that it received $400,000 less in funding from these sources in the year after

installation housing was privatized and servicemembers on Fort Carson began receiving BAH. NMFA urges the Departments of Defense, Agriculture, and Education

to examine how school funding can be protected during the implementation of privatization projects.

FIX THE SCHOOLHOUSE

For a newly-arrived family in a military community, the sight of a well-maintained, safe, child-friendly school building can calm many anxieties about the latest

move. Unfortunately, too many military children must deal with those anxieties in

a school facility that has seen better days. Their military parents see the deteriorating school building as perhaps a symbol of a deteriorating respect for their service to the country. Although Impact Aid provides much of a heavily-impacted district’s working capital, a district’s payment cannot usually be stretched to fund the

facility maintenance and improvements old school buildings need. Military families

at many installations voice concerns about the repairs needed for these buildings

and the lack of available funds. Obtaining funding to construct and renovate school

buildings is a challenge for school districts across the country, not just districts receiving Impact Aid; many U.S. school buildings were built in the fifties and sixties

and need major work to meet handicapped accessibility standards and to be able

to handle modern technology. The reduced tax base of districts dependent on Impact

Aid often makes it difficult for these districts to float the necessary bond issues to

construct new schools or renovate existing buildings.

NMFA remains concerned about the inadequate funding to upgrade and maintain

buildings owned by the Department of Education. The co-terminous districts—those

civilian districts whose boundaries are the same as the military installations they

serve—have received funds in recent years out of the Department of Defense budget

to help with repair and renovation projects. Some of these districts have school

buildings owned by the Department of Education. Even with the DOD funding,

these districts still face difficult prioritization decisions on how to address facility

shortfalls. Randolph Independent School District, serving Randolph Air Force Base

in San Antonio, TX, estimates that it needs $14 million to meet the facility needs

in its Department of Education-owned buildings. The district must address safety

and structural needs before addressing a priority of many military families: renovating a room that is too small to accommodate the district’s award-winning band.

Other districts, with a mix of schools owned by the district and by the Department of Education, have not received the funding they have needed to take care of

these buildings. They have been forced to use district funds to bring the Department

of Education-owned buildings up to district standards so that the military children

attending these schools will not fall behind their peers in district-owned buildings.

NMFA is pleased to note the increased amount requested for construction in the administration’s budget proposal and urges Congress to allocate adequate construction

funding in the Impact Aid budget for districts that do not have other funding alternatives available.

ONE CHILD, MANY SCHOOLS

The education of a military child is a continuum. As the military child moves from

school district to district—from a school receiving Impact Aid in California, to another Impact Aid school in Texas, to a Department of Defense school in Japan, to

an Impact Aid school in Kansas—the quality of education she receives in one school

may well affect the education she and her classmates receive in the next. Children

whose schools are unable to provide the necessary educational services could easily

fall behind their peers in other districts. Schools serving these children could face

difficulties in maintaining accreditation as tough new standards are implemented

in many states. A smooth transition into their next school, whether across the state

or around the world, benefits military children, their classmates, and their communities. The Impact Aid program enables districts affected by the presence of a military installation to offer not only a quality basic education program, but also the

support services needed by military children as they transition from school to school.

Recognizing that servicemembers view quality education as an important quality

of life factor and a retention issue, the military services have stepped up their ef-
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1The college is owned and operated by five federally-recognized tribes situated wholly or in

part in North Dakota—Spirit Lake Sioux Tribe, Sisseton-Wahpeton Sioux Tribe, Standing Rock

Sioux Tribe, Three Affiliated Tribes of the Fort Berthold Reservation, and Turtle Mountain

Band of Chippewa. Control of the institution is vested in a ten-member board of directors comprised of elected Tribal Chairpersons and Tribal council members.

forts to establish partnership programs with local schools, to train installation

school liaison officers, to provide better information to families about local schools,

and to study the problems faced by military children as they move. The Services

are adopting proposals to facilitate parent involvement in schools, such as the policy

at Fort Hood, TX and other installations that states a servicemember’s place of duty

is the scheduled parent-teacher conference. The Army has addressed the difficulties

students’ face when moving in their senior year by recently instituting a Senior Stabilization Policy that enables the soldier to request a delay in PCS orders so that

a rising senior can finish high school at the current location. Personnel are working

across the Services on common issues and are reaching out to military-related and

education organizations. NMFA applauds DOD’s creation of the Educational Opportunities Directorate to address the needs of all military children wherever they go

to school. The Directorate has established a Special Needs Website

(www.mfrc.calib.com/snn) as a resource for military as well as for schools and service providers. The Directorate is currently conducting a series of roundtables in

states with high military populations to raise awareness of issues affecting the mobile child among parents, state and local education policymakers, and installation

officials.

School districts are responding to military families’ concerns about quality education and to the military Services’ desire to develop partnerships by devoting resources to training their personnel on transition issues and to setting up more transition programs. They recognize their interdependence and their shared responsibility for the education of military children and are increasing their communication

with each other to ease children’s transition in and out of different school systems.

Military parents view the partnerships between their schools and the military

Services—from the unit adopting the local elementary school to the presence of

Service and DOD leadership at educational conferences on the military child—as

progress toward relieving some of the anxieties about their children’s education. The

educational focus of these efforts is a legacy of a successful, well-funded Impact Aid

program. When the Federal Government fulfills its responsibility to provide funding

for basic education to districts serving military children, the schools can concentrate

on providing a high-quality education program for all students. We thank you, the

Members of this Subcommittee, for your leadership in this partnership for the education of military children. We ask you to continue this role by meeting the Federal

obligation to fully fund Impact Aid.

PREPARED STATEMENT OF THE UNITED TRIBES TECHNICAL COLLEGE

SUMMARY OF REQUEST

For 32 years United Tribes Technical College 1 (UTTC) has been providing postsecondary vocational education, job training and family services to Indian students

from the Great Plains and throughout the nation. Our request for fiscal year 2002

funding for tribally controlled postsecondary vocational institutions as authorized

under Carl Perkins Vocational and Applied Technology Act is:

—$6 million, or $400,000 over the fiscal year 2001 enacted level. This funding is

essential to our survival as we receive no state-appropriated vocational education monies.

In addition we request:

—Funding for renovation of our facilities, many of which are original to the Fort

Abraham Lincoln army installation and are on the National Register of Historic

Places. A recent study commissioned by the Department of Education and submitted to Congress shows a facility need for UTTC of $49 million.

FUNDING AUTHORITY

Section 117 of the Carl Perkins Vocational Education and Applied Technology

Education Act Amendments of 1998 authorizes funding for tribally controlled postsecondary vocational technical institutions. Under this authority funding is currently provided to UTTC and one other tribally controlled postsecondary vocational

institution, the Crownpoint Institute of Technology. We do not receive funding

through the Tribally Controlled Community Colleges Act.
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A UNIQUE INTER-TRIBAL EDUCATIONAL ORGANIZATION

United Tribes Technical College is the only inter-tribally controlled, campusbased, postsecondary vocational institution for Indian people. Our campus is the site

of the Fort Lincoln Amy Post, an 110-acre area near Bismarck, North Dakota. We

currently enroll 371 students from 32 tribes and 14 states. And we serve 155 children in our pre-school programs and 175 children in our elementary school, for a

direct services population of 701.

EDUCATING STUDENTS AND CONTRIBUTING TO THE ECONOMY

We are proud of the education, skills and services provided by UTTC for our students and their families. And we are proud that this education is taking place in

a setting they where can maintain and strengthen their tribal heritage. The average

age of our students is 28. 68 percent of our students are female, and 45 percent of

student are single parents with an average number of dependents of 2.5. We have

had a sustained job placement rate exceeding 80 percent over the last 10 years. This

success is all the more gratifying in light of the background of our students, most

of whom come from tribal areas where poverty and unemployment are the norm.

Many of our students are from the 14 tribes in the Dakotas, where unemployment

among Indian people is chronic. BIA Labor Force data reports the percentage of potential Indian labor force on and near reservations in the Aberdeen Area who are

jobless is 71 percent. Of those persons who are employed 33 percent are still living

below the poverty guidelines. (Source: Interior Department 1999 Labor Market Information On the Indian Labor Force.)

We believe that a primary reason for UTTC student success is that we serve the

students’ social, academic and cultural needs. Many of our students are the first

generation in their family to attend college, and for many it is their first experience

in living away from home. Many students are on public assistance and many have

families of their own. Some of our services are:

—Early childhood services for 145 children, ages birth to 5 years and an additional 12 elementary children for extended care.

—Theodore Jamerson Elementary School serving 148 Indian students;

—A health clinic whose services includes immunization, health education, eye and

dental exams, and referrals to other health care providers;

—Family housing and dormitories for solo parents and for students without children;

—A local transportation system for students for school activities and necessary

appointment e.g., (doctor appointments) outside the campus. Most UTTC students do not have cars.

UTTC is a major business contributor to the state of North Dakota. We undertook

a study of the economic impact for 1999 of our institution on the state of North Dakota, and found, using only four key dollar impact areas, the economic impact created by UTTC was $34 million. This study did not encompass all the meetings and

conferences that UTTC was directly or indirectly responsible for bringing to Bismarck. Thus, the economic impact in 1999 was even greater than indicated in our

study (‘‘Economic Impact by United Tribes Technical College on the BismarckMandan Community and North Dakota—January 2001’’)

UTTC NEW COURSE OFFERINGS

We offer 9 Certificate and 15 Associate of Applied Science degree programs. We

are very excited about the recent additions to our course offerings, and the particular relevance they hold for Indian communities. The modest increases in our Department of Education funding has helped make these new programs possible.

These new programs are:

—Injury Prevention

—Food and Nutrition

—Tribal management, including gaming management

—Computer Support Technician

—Distance Learning programs

Food and Nutrition/Diabetes.—UTTC will meet the challenge of fighting diabetes

through education. As this Subcommittee knows, the rate of diabetes is very high

in Indian county, and with some tribal areas experiencing the highest incidence of

diabetes in the world. About half of Indian adults have diabetes (‘‘Diabetes in American Indians and Alaska Natives, NIH Publication 99–4567, October, 1999).

The College currently offers a Food and Nutrition Associates to increase the number of American Indians with expertise in human nutrition and dietetics. Currently,

there are only a handful of Indian professionals in the country with training in
437

these areas. Future improvement plans include offering a Nutrition and Dietary

Management degree with a strong emphasis on diabetes education and traditional

food preparation.

United Tribes Technical College has also established the United Tribes Diabetes

Education Center to assist local Tribal communities and UTTC students and staff

in decreasing the prevalence of diabetes by providing diabetes educational programs,

materials, and training.

Injury Prevention.—Through our Injury Prevention Program we are addressing

the injury death rate among Indians which is 2.8 times that of the U.S. population

(Source: IHS fiscal year 1999 Budget Justification). We received assistance through

the IHS to establish the only degree-granting Injury Prevention program in the nation.

Computer Support Technician.—High demand exists for computer technicians. In

the first year of implementation, the program is at maximum student capacity. In

order to keep up with student demand, UTTC will need more classroom space, computers and associated equipment, and instructors. Our program includes all of the

Microsoft Systems certifications which translates into high income potential.

Distance Learning.—We are bridging the ‘‘digital divide’’ by providing web-based

education from our North Dakota campus to American Indians residing at other remote sites, including the Denver Indian community. Training is currently provided

in the areas of Early Childhood Education and Computer Literacy. By the year

2005, students will be able to access full degree programs in Computer Technology,

Injury Prevention, Health Information Technology, Early Childhood Education, and

Office Technology, and others from these remote sites. Online education allows all

American Indians an opportunity to overcome barriers such as geographic isolation

and access to culturally relevant education. Through partnership programs, UTTC

is meeting the challenge of providing technology skills and training to Indian country.

In addition, UTTC has been a member of the Interactive Video Network of North

Dakota’s colleges, universities, and tribal colleges. This allows for collaborative arrangements with other colleges and universities, expanding the educational opportunities for our students.

OTHER UTTC INITIATIVES

Northern Plains Bison Research.—UTTC is coordinating reservation-based field

research under the Northern Plains 1862/1994 Land Grant Institutions Bison Research Collaborative. The overall project goal is to enhance the quality of prairie

rangeland conditions that will sustain the spiritual and physical well being of Tribal

bison herds. Research activities are focused on the habitat and nutrition needs of

bison herds on North and South Dakota reservations.

Job Training and Economic Development.—UTTC is a designated Indian Minority

Business Center serving Montana and the Dakotas. We also administer a Workforce

Investment Act program and an internship program with private employers. And we

are assisting tribes and tribal members in the Aberdeen Area with rebuilding their

economies and buffalo herds.

Coordination with State Welfare-to-Work Efforts.—UTTC is working in cooperation

with the state of North Dakota and Tribal JOBS programs on addressing the effects

of welfare reform. The campus Child Development Center provides early childhood

services for 91 families. This includes an Extended Care program so that students

are able to complete TANF work requirements, complete Cooperative Education internships with private employers, and complete other work activities.

In North Dakota, only 33 percent of state TANF recipients are allowed schooling

as a work activity. The 12-month statutory limit on length of time a TANF recipient

can be enrolled in a vocational education course of study presents additional barriers for single parent families. This limits TANF recipients to taking 1-year certificate courses at UTTC. Our experience shows that the students who graduate from

a 2-year, rather than a 1-year, course of study have significantly higher earning

power. Many of our students come to UTTC planning to take a 1-year course, and

then, finding themselves in a supportive environment and seeing the economic benefit of the longer course, decide to work for the 2-year degree.

NEW STUDY DOCUMENTS OUR FACILITY NEEDS

The 1998 Perkins Act required the Department of Education to study the facilities, housing and training needs our institution. That report, conducted for the Department of Education by the American Institutes for Research, was published in

November 2000 (‘‘Assessment of Training and Housing needs within Tribally Controlled Postsecondary Vocational Institutions, November 2000, American Institute of
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Research’’) The report identified the need for $16,575,300 for the renovation of existing housing and instructional buildings ($8 million if some existing facilities are

converted to student housing) and $30,475,000 for the construction of housing and

instructional facilities. Our core facilities range from 90 to 100 years in age. Originally the site was a military post built as Fort Abraham Lincoln. UTTC acquired

its use and eventual ownership in 1968.

If not adequately addressed, these costs will inevitably continue to grow as the

buildings age and inflation rises. The following needs must be addressed if the College is to remain in existence and increase its capacity.

Housing.—UTTC continues to identify housing as its greatest need. UTTC has a

huge waiting list of students—some wait from one to 3 years for arrival. New housing must be built to accommodate those on the waiting list as well as to increase

enrollment. Existing housing must be renovated to meet local, state, and federal

safety codes. In the very near future, some homes will have to be condemned which

will mean lower enrollments and fewer opportunities for those seeking a quality

education. Single student housing must also be built and expanded to meet the College’s needs.

Classrooms & Offices.—This type of space is at a premium. The College has literally run out of space. This means that the UTTC cannot expand its course offerings to keep up with job market demands. Most offices and classrooms that are

being used are quite old and are not adequate for student learning and success.

OTHER AREAS OF NEED

Devastating Utility Increases.—Utility costs have skyrocketed due to increases in

natural gas. UTTC’s utility costs have increased by 65 percent. This has put a major

added burden on the school and is causing a funding dilemma, since we do not have

the option of relying on state appropriated resources or other fixed cost revenues.

Inadequate Salaries.—We were able to provide a cost-of-living increase for our employees last year. However, our faculty and staff still receive salaries that are lower

than any state college system in the 50 states. (Source: Integrated Postsecondary

Education Data Systems Report of the U.S. Bureau of the Census and the Department of Education Office of Education Statistics.)

Course Offerings/Student Services.—We hope to change some of our courses to

better meet new market demands, e.g. training to increase the number of students

in the allied health professions, updating of technology. We also need to expand our

diagnostic capabilities in tribal-specific areas and in the areas of literacy and mathscience background. And, we want to make improvements in our student follow up,

career development, and job market research efforts.

Thank you for your consideration of our request.

PREPARED STATEMENT OF THE UNIVERSITY OF TULSA

It is proposed that the Department of Education support an information technology center for the University of Tulsa. We are seeking $13 million for building

and equipment needs.

THE UNIVERSITY OF TULSA CENTER FOR INFORMATION TECHNOLOGY

It is a reality that economies are increasingly linked to technology. In February

2000, Oklahoma Governor Keating hosted a round table discussion of technology,

educational, and commerce leaders in Tulsa. As a result of that meeting, a Center

of Excellence in Information Technology and Telecommunications was formed. Participants in the Center include the University of Tulsa, Oklahoma State UniversityTulsa, the University of Oklahoma’s Tulsa operations, Oral Roberts University,

Tulsa Community College and Tulsa Technology Center.

The University of Tulsa is poised to help ensure that the Center of Excellence in

Information Technology and Telecommunications meets the needs of industry and

fulfills its mission of advancing the industry through research and educational programs. However, we are in need of a state of the art technology center to optimize

our educational and research opportunities.

There are a number of significant benefits that will flow to the State of Oklahoma

and the Tulsa community from an investment in a TU Center for Information Technology (IT). These include:

—Attracting and retaining quality students

—Enhanced educational opportunities

—Research opportunities for both faculty and students
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Attracting and Retaining Quality Students

TU is committed to quality education. The University of Tulsa faculty is nationally recognized. For example, last year the Carnegie Foundation honored two University of Tulsa professors for the Advancement of Teaching and Learning. One was

named a Carnegie Professor of the Year and one was named a Pew Scholar. In the

past five years, The University of Tulsa, MIT and Stanford produced an equal number of Goldwater Scholars, tying for seventh place in the nation. The TU Center for

IT would provide the infrastructure to maximize the potential of integrating these

quality students with quality faculty. However, the Center would prove beneficial

even before students arrive on campus. The recruiting competition for quality students is fierce. Students judge the technology infrastructure of a college or university when selecting an institution of higher learning. Students often make the decision to stay at a college or university based on opportunities for access to state of

the art technology. TU wants to educate the technology knowledge workers to enter

the digital economy work force and the Center would allow us to nationally recruit

quality students to Oklahoma.

Enhanced Educational Opportunities

The TU Center for Information Technology will enhance educational opportunities

in three areas:

—by providing tools/resources to enhance learning in all academic areas and disciplines,

—by providing an infrastructure for technology based program students (such as

management information systems, computer information systems, and computer

science) students to complement in class learning by applying their classroom

learning, and

—by enabling TU to deliver education to a broader range of constituents—students in divers geographic regions. It will also enable TU to reinforce the lifelong learning we encourage our alumni to pursue.

Research Opportunities

The TU Center for Information Technology will provide resource opportunities for

both University of Tulsa faculty, and graduate/undergraduate students. Due to the

number of industry leaders located in Tulsa, TU researchers have access to a significant volume of relevant subjects and data. TU’s research program for undergraduate

students (known as TURC—the Tulsa Undergraduate Research Challenge) is nationally recognized and acclaimed. Students have won a variety of national scholarships and grants from prestigious organizations such as the National Science Foundation and the Department of Energy. The enhanced research labs available in the

TU Center for IT would further enhance the success of this program.

In summary, the combination of quality professor, students, and technology infrastructure will result in a win-win proposition for students of higher education in

Oklahoma and the Oklahoma economy.

PREPARED STATEMENT OF THE CROWNPOINT INSTITUTE OF TECHNOLOGY

This testimony addresses appropriations under The Carl D. Perkins Vocational

Education Act, Section 117 ‘‘Tribally Controlled Vocational and Technical Institutions.’’ On behalf of the Crownpoint Institute of Technology, (CIT), I thank this Subcommittee for providing very necessary and deeply appreciated appropriations to

Section 117 for tribally controlled vocational educational institutions. CIT is aware

of only two such institutions in the nation. Funding to the U.S. Department of Education by this Appropriations Subcommittee for Section 117 has enabled CIT to provide vocational and technical education and training to over 400 students annually.

CIT graduates enter our nation’s workforce with highly marketable employment

skills.

While this appropriation has been greatly appreciated and extremely well-utilized

for the education of Native American young adults, CIT believes the most significant

situation relevant to Section 117 appropriations is that on March 27, 2001 the U.S.

Department of Education unexpectedly issued new regulations and application

guidelines that drastically redirect this appropriation. The Department ruled that

minor changes in the 1998 reauthorization to Section 117 constituted a ‘‘substantial

revision,’’ and therefore expanded eligibility to tribal institutions already supported

under other statutes. CIT does not agree that Section 117 of the reauthorization law

was revised. Attached with this testimony is a side-by-side comparison of the 1990

and 1998 ‘‘Tribally Controlled Postsecondary Vocational Institutions’’ definitions

demonstrating that there are no substantial revisions to the definitions of eligible
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institutions. Our most important request to this Subcommittee is for assistance and

intervention in ensuring that the intent of the Congress is carried out in the Department’s awarding of funds under Section 117 beginning with fiscal year 2001 appropriations which this Department of Education March 27, 2001 Notice redirects effective May 29, 2001.

The Title for Tribally Controlled Postsecondary Vocational Institutions was enacted to create a stable base of operational support for those tribal colleges that

were not eligible for the ‘‘Tribally-controlled Community Colleges Assistance Act.’’

That 1978 act followed the U.S. Congress policy of Indian Self-Determination, which

allowed tribes to manage their own institutions, and provides basic operational support for tribal colleges through Interior appropriations into the present time. The

Tribal Colleges Act supports all but two of the nation’s tribally controlled colleges.

The Crownpoint Institute of Technology (CIT) is one of these two excluded tribal colleges. The reason for the exclusion is a provision in the Tribal Colleges Act that limits each Tribe to one college. On its surface this statutory limitation may seem reasonable. The average population of tribes having tribal colleges ranges between

3,000 and 10,000 members. The Navajo tribe is a population anomaly among Indian

tribes with 225,298 members as verified by the most recent U.S. Census. Dine College, Tsaile, Arizona, is the Navajo Tribal College funded under Interior’s Tribal

Colleges Act. Founded in 1969, Dine is the first of the nation’s tribal colleges. CIT

was founded in 1979, one year after enactment of the Tribal Colleges Act and even

then was originally created as a job skills center. The ensuing decade saw CIT’s evolution from a job-training center to a full-fledged vocational technical college. Skilled

employment opportunities expanded for students graduating with credentialed degrees, and CIT earned full institutional accreditation from North Central Association of Colleges and Schools in 1987. CIT’s outstanding success at providing its students with highly marketable career skills has enabled over 4,000 Navajo adults to

leave the welfare roles behind forever. This is how the Navajo Nation came to have

a second college.

The size of the Navajo population warrants a second college. Throughout our nation, colleges are created to serve population bases. The number of tribes is irrelevant. There are sixteen Indian tribes in the three States of Montana, North Dakota

and South Dakota. Each of these tribes has a tribal college supported by Congressional appropriations. Yet the combined population of on-reservation, all-ages of

these sixteen tribes is 72,835. An enrollment base establishes the need for any educational institution. It is illogical by any standard to erect sixteen colleges for a

73,000 population, while simultaneously limiting a 225,000 population to only one

college. However inadvertently, this is exactly what the Congress did in 1978 with

enactment of Public Law 95–471, ‘‘The Tribally Controlled Community Colleges

Act.’’

Geographic access to postsecondary education is another significant factor in establishing the need for a college, and was a primary consideration for most tribes

in founding their own colleges. The Navajo Nation is 26,897 square miles extending

into three States: Arizona, New Mexico and Utah. The Navajo Nation reservation

is 2,810 square miles larger than the State of West Virginia, and only slightly smaller than the five New England States of Vermont, New Hampshire, Massachusetts,

Connecticut and Rhode Island combined. The driving distance across this reservation is approximately nine hours. In the remote vastness of this reservation in

America’s Southwest, geographic access to postsecondary education for Native people would not exist for most citizens without these two tribal colleges.

The existing tribal colleges adamantly opposed many years of CIT’s efforts to

amend the Tribal Colleges Act to allow a second college in a situation of exceptional

population. In 1990, Congress enacted the ‘‘Tribally Controlled Postsecondary Vocational Institutions’’ provisions to provide federal assistance to tribal colleges not eligible for Interior appropriations under the Tribal Colleges Act. At that time there

were only two such colleges in the nation, and their primary mission was and remains vocational/technical education. Thus, the provision was included in the Carl

D. Perkins Vocational Education Act. The second of these anomaly tribal vocational

colleges is United Tribes Technical College (UTTC) located in Bismarck, North Dakota. The four tribes of North Dakota charter UTTC that each already had an onreservation tribal college funded under the Tribal Colleges Act. More than two decades after their founding, there remain only two tribal vocational colleges in the nation, although during these same years several new tribal community colleges have

been added under the Tribal Colleges Act. Each of those colleges is the only college

that the sponsoring tribe has chartered. The vast majority of tribes have never

founded a first tribal college. Due to the small populations of most tribes, it is highly unlikely that any tribe other than the Navajo will ever found a second tribal college. In the situation of the Navajo people, remote geography and population
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uniquely combined to predicate this unusual need for a second postsecondary institution.

The 1998 Reauthorization of the Carl D. Perkins Vocational Education Act saw

some major revision, but the Tribally Controlled Postsecondary Vocational and

Technical Institutions provision remained essentially intact because the situation it

addressed remained essentially the same. Because Section 117 contained only minor

changes, Congressional sponsors did not accompany enactment with a statement of

the intent of the Congress. The absence of such statement of the intent of Congress

served as the Department of Education’s justification to abruptly proclaim on March

27, 2001, more than two and one half years after 1998 enactment, that Section 117

definition of eligibility was ‘‘substantially revised.’’ In response, a colloquy by the authorizers reiterating the intent of the Congress as to this provision was published

in the April 26, 2001 Congressional Record and provided to the Department. Upon

receipt of the requested clarification, the Department declined to withdraw the competition, which expands eligibility for appropriations to all tribal colleges, which already receive their basic operational support under Interior’s Tribal Colleges Act.

A technical amendment is in process. However, it is unlikely that this amendment

can be enacted in time to affect awards under fiscal year 2001 appropriation because the Department’s unretracted grant application deadline is May 29, 2001 with

the fiscal year 2001 program year beginning the following month. This Subcommittee increased the fiscal year 2001 appropriation from $4.6 to $5.6 Million,

under which CIT’s student count allocation is desperately needed to remain in operation. Under the Department’s new guidelines, CIT would lose at least 70 percent

of its operational funding, and in a worst case, would not even be one of the institutions selected in the competition by the Department at all. In either case, CIT would

not be able to open its doors for classes in August 2001, and will be forced to furlough employees beginning June 2001. Presently, CIT is only able to renew faculty

contracts provisionally, subject to continued Section 117 funding. The potential loss

of faculty to other more secure employment would have a devastating effect on CIT.

We urge this Subcommittee to do all in its power to intervene and ensure that its

fiscal year 2001 Section 117 appropriation is spent according to the law and the intent of the United States Congress.

CIT believes it has established its merit as a tribal institution worthy of federal

assistance. CIT has an eight-year average student retention rate of 95 percent, and

an average job placement rate of 86 percent over the same period. CIT’s current enrollment is 492 headcount or 423 Full Time Equivalency/Indian Student Count, an

increase of thirty students over academic year 1999–2000. Through tribal HUD assistance, CIT has expanded married/family on-campus housing to accommodate

those students possibly most in need of jobs, students with dependant children. CIT

is a dormitory-based institution and off-campus housing in scarce. Each year, student applications continue to surpass capacity and CIT has a waiting list of over

200 otherwise qualified applicants.

CIT offers fully-accredited two year Associate of Applied Science degrees and/or

one year certificates in high employment demand fields including Accounting, Administrative Assistant, Applied Computer Technology, Automotive Technology,

Building Maintenance, Carpentry, Culinary Arts, Electrical Trades, Environmental

Technology and Natural Resources, Law Advocate, Legal Assistant, Nursing Assistant and Veterinary Assistant. For academic year 2001–2002, CIT has prepared to

offer Dental Assistant and Health Technician in response to a high employment demand and shortage of skilled workers in these fields. CIT has already secured donated dental training equipment enabling it to maximize its use of federal assistance in this program.

Over 10,000 young adults graduate from Navajo area high schools each year. The

decennial Indian population increase is 14 percent as compared to only 8 percent

for mainstream America. Median Native American population age is now 27.4 years,

8 years younger than the median age for mainstream America. CIT’s average student age is 26, although the actual range has been 18–64. CIT is open to and welcomes all qualified Indian and non-Indian applicants, and as just one example has

retrained displaced non-Indian uranium workers from neighboring towns. However,

the primary mission for this institution is to rectify the joblessness and hopelessness

so prevalent among too many of the more than 200,000 on-reservation people. CIT

graduates earn an average $15,075 average entry-level annual wage upon graduation. Each employed graduate pays an average of $2,261 of their earnings to federal

taxes in the first year of employment alone. While tax contributions vary according

to number of dependents and other factors, in general wages and tax contributions

over an average thirty years of employment and tax paying. CIT lacks institutional

resources to track all of its more than 4,000 graduates of the past two decades, but

of those tracked, 61 percent are employed in private industry and do not rely on
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federal appropriations for jobs. In an average lifetime of employment, CIT graduates

will return to the federal government the cost of its investment many times over

through tax contributions as well as through remaining off the welfare rolls.

It will have been a tragic loss of the investment of two decades that brought CIT

to the educational institution it is today if federal operational assistance is so

abruptly withdrawn. Over the past decade, a significant investment of tribal and

federal funding has brought CIT facilities up to the standards that ultimately result

in CIT graduates’ abilities to succeed in the mainstream American economy. CIT

opened its state-of-the art Veterinary teaching clinic last year. This teaching clinic

will greatly enhance the way of life that remains traditional for most Navajo people,

which relies on livestock yield. Over three years, a more than $4 Million EDA grant

enabled the replacement of trailers with actual classrooms. In addition, this same

EDA funding repaired dormitories damaged by years of soil contraction, an unforeseen construction problem endemic to the Southwest when CIT was originally built

by the Federal Government. CIT Administrative buildings, also damaged beyond repair by this same problem, were replaced with new mobile units in order steer maximum facilities improvements directly to the students. The Navajo Nation invested

their HUD funding to increase housing capacity for students with dependent children. Sixteen of a projected thirty-two units now have resident student families on

their way to acquiring life-long employment skills to support these families. The

Navajo Nation sacrificed much to ensure that CIT provides education equal to that

provided in mainstream America so that our graduates can compete on a level playing field. It will be a tragic waste of this investment if federal assistance to CIT

is withdrawn by the Department’s radical new funding interpretations. We deeply

thank this Subcommittee for all its assistance and urge that it take all action possible to ensure that its appropriations reach the recipients that the law specifies and

that the Congress intended.

PREPARED STATEMENT OF THE ALPHA ONE FOUNDATION

Mr. Chairman and members of the Committee thank you for the opportunity to

submit testimony for the record on behalf of the Alpha One Foundation.

THE ALPHA ONE FOUNDATION

The Alpha One Foundation is a national not-for-profit organization dedicated to

providing the leadership and resources that will result in increased research, improved health, worldwide detection and a cure for Alpha1-Antitrypsin (Alpha-1) Deficiency.

ALPHA-1 IS SERIOUS AND LIFE THREATENING

Alpha-1 is a genetic disorder that can result in devastating and fatal lung and

or liver disease that is often misdiagnosed as asthma or Chronic Obstructive Pulmonary Disease (COPD). Alpha-1 afflicts an estimated 100,000 individuals in the

United States with fewer than 6,000 accurately diagnosed. Alpha-1 is a major cause

for lung transplantation in adults.

The pulmonary impairment of Alpha-1 causes disability and loss of employment

during the prime of life, frequent hospitalizations, family disorganization, and the

suffering known only to those unable to catch their breath. Lung transplantation,

with all its associated risks and costs, is the most common final therapeutic option.

Alpha-1 is the primary cause of liver transplantation in infants and an increasing

cause in adults. Untreated individuals can have their life expectancy reduced by 20

or more years.

Alpha-1 is a progressive and devastating disorder that in the absence of proper

diagnosis and therapy leads to premature death; in spite of the availability of therapeutics and preventative health measures that can be life prolonging.

THE MEDICAL NEEDS OF THE ALPHA-1 COMMUNITY HAVE GONE UNMET

Alpha1-Antitrypsin Deficiency is a hidden killer that desperately needs new therapies. It masquerades as asthma, chronic usual obstructive lung disease and

bronchiectasis. There is a lack of awareness of the insidious nature of the early

symptoms of the lung disease associated with this genetic condition by both medical

care providers and the public.

Currently, the only specific therapy for Alpha-1 is intravenous augmentation therapy produced from pooled human plasma at an average annual cost of $50,000.00.

This single source therapy, initially marketed through the Orphan Drug Act, increases the plasma levels of the deficient protein and appears to slow or halt the
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progression of the pulmonary disease described above. Unfortunately, this therapy

has been in short supply over the past several years. During prolonged shortages,

individuals on therapy were forced to reduce the dosage of drug being administered

or prolong the duration of time between treatments. No data is available concerning

the potential efficacy of these untested treatment regimens. As new patients were

identified, they were unable to obtain drug during these periods.

SUPPORT FOR RESEARCH

The Alpha One Foundation believes that significant federal investments in medical research are critical to improving the health of the American people and specifically those affected with Alpha-1. The Foundation is supportive of the goal set by

Congress of doubling the National Institutes of Health (NIH) budget by fiscal year

2003. At the proposed funding level NIH will be able to support the highest level

of new and competing research project grants, and the highest level of total grants

in NIH history.

It is fair to state that the support of this Subcommittee has made a substantial

difference in improving the public’s health and well-being. The Foundation requests

that the increase in the NIH budget will reflect an increase in the Alpha1- Antitrypsin Deficiency research portfolio to achieve the following goals:

—The Promotion of basic science and clinical research related to the AAT protein

and AAT Deficiency.

—The funding to attract and train the best young clinicians for the care of individuals with AAT Deficiency.

—The support for outstanding established scientists to work on problems within

the field of AAT research.

—The Development of effective therapies for the clinical manifestations of AAT

Deficiency.

10 SPECIFIC AREAS OF CONCERN

1. Increase the level of funding for investigator-initiated research.—Our best ideas

to cure and prevent Alpha-1 come from individual scientists working in the laboratory and with patients. We recommend that the NIH budget be increased to allow

an increased number of scientifically meritorious grant proposals that are investigator initiated be funded.

2. Provide significant increases in federal funding to attract, educate, and train

more clinical and translational researchers.—We need continued replenishment of

leaders to bring findings from the laboratory bench to the bedside. We must recruit

new clinicians to become involved in clinical research. This is becoming more and

more difficult as managed care tightens budgets and allows little if any time for

physicians to engage in research. We must address this issue if we are to have the

trained personnel needed to prevent and cure Alpha-1 in the next 5 to 10 years.

3. Increase individual grants for scientific conferences and workshops.—Increase

the number and amount of grants available to sponsor scientific conferences and

workshops in order to increase the promotion and participation in these forums.

4. Fund targeted screening and detection.—In 1989 the HHS National Commission

on Orphan Diseases estimated that only 30 percent of the 25 million patients suffering with rare diseases receive a diagnosis in three to five years after the onset

of symptoms. That works out to about 7.5 million patients who are shuffled from

specialist to specialist, year after year. Fifteen percent, or 3.7 million people, wait

seven years or more. The average patient with Alpha-1 sees 5 physicians over 7

years before they are properly diagnosed. In addition only 6 percent of those estimated to have Alpha-1 have been identified. A targeted screening and detection plan

should follow the recommendations of the World Health Organization’s report on

Alpha-1 and promote appropriate treatment and positive health interventions. Research has shown that early diagnosis and treatment leads to fewer long term

health complications and a better quality of life.

5. Establish ‘‘centers of excellence’’ to support proactive initiatives in Alpha-1 treatment.—We must focus our efforts to further reduce smoking, understand and improve dietary habits and undertake a national effort to identify and test potential

Alpha-1 patients in an effort to offer the best therapies and life prolonging preventative health strategies.

6. Initiate health surveillance for frequent plasma recipients.—Blood carries inherent risks that increase for life-long recipients. Although all plasma-derived products

are virally inactivated, there are concerns about new and emerging pathogens and

their ability to be transmitted through blood. Targeted surveillance of the Alpha1 community would allow for an early warning system should such a threat be

present in the blood supply. Specifically, the Foundation welcomes an evaluation of
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the experience of this long term and frequent recipient cohort of pooled plasma derivatives.

7. Capitalize on the unprecedented number of opportunities to create new therapeutics through increased funding and public-private partnerships.—The medical

needs of the Alpha-1 community will go unmet without the development of new

therapies. The final delivery of new therapies depends on the overall process of drug

development and clinical trials, and in the case of therapies for orphan disease this

process is often burdensome and prohibitively expensive. Academic institutions and

the private sector carry out these expensive processes. To fully leverage the

strengths of these sectors and validate new therapies there must be resources to

fund the expedited development of unprecedented and novel public-private partnerships.

8. Fund programs to improve the quality of life.—Alpha-1 is a tragic disease that

extracts a great deal in terms of human suffering from its victims and their families. We must provide programs that address critical issues such as pain and fatigue

and end-of-life issues for patients and families. Preventative measures, environmental effects, psychosocial, economic and ethical issues related to Alpha-1 should

be fully explored.

9. Fund initiatives that will address research questions dealing with disparities in

minority, and underserved populations, and accelerate programs to ensure early detection, and treatment.—We must make every effort to reduce and equalize disease

rates across all populations. The Foundation supports increased funding for programs that ensure that all populations receive the benefit of research and that

health disparities do not continue among minority populations.

10. Adequately fund the Office of Rare Diseases.—Finally, the NIH needs to ensure

that all Americans, not just a select few, have access to the incredible work being

done at the NIH. Today, only ten cents for each and every person suffering with

a rare disease is dedicated to ORD. We request a significant increase in this funding

amount.

CONCLUSION

The Alpha One Foundation supports an increase of $3.4 billion for fiscal year

2002, in the hope that this increased investment in the National Institutes of

Health will translate into an increase in the resources dedicate to research and

awareness of the devastating disorder: Alpha1 Antitrypsin Deficiency.

PREPARED STATEMENT OF THE ASSOCIATION OF SCHOOLS OF PUBLIC HEALTH

The Association of Schools of Public Health (ASPH) is the only national organization representing the deans, faculty, and students of this nation’s 29 accredited

schools of public health and graduate programs seeking accreditation as schools of

public health in the United States and Puerto Rico. These schools have a combined

faculty of over 2,500 and educate more than 15,000 students annually from every

state in the U.S. and most countries throughout the world. The schools graduate approximately 5,000 professionals each year. The 29 schools of public health constitute

a primary source of comprehensively trained public health professionals and specialists in short supply to serve the Federal Government, the 50 states and the private

sector. Yet according to the DHHS, public health professionals are in short supply.

On behalf of the 29 graduate schools of public health in the U.S. and Puerto Rico,

the Association of Schools of Public Health (ASPH) hereby submits a statement for

the hearing record on the association’s fiscal year 2002 appropriations requests for

programs of primary concern in the U.S. Public Health Service. There is a chart on

page five that outlines these recommendations. Consideration of these requests by

the Subcommittee is appreciated.

PREVENTION RESEARCH CENTERS (CDC)

The Congress established the CDC prevention research centers program in 1985

to provide grants to academic institutions to fund applied research programs designed to develop new and innovative strategies in health promotion and disease

prevention. Through this program, faculty expertise of schools of public health is

made available to federal, state and local health officials, community-based organizations and nonprofit organizations. Additionally, the centers serve as sources of

education and training for America’s next generation of public health professionals.

Unfortunately, the funding level for the program has never reached the level that

Congress intended when authorizing the program.
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1There is a large under-trained public health workforce of more than 400,000 who have no

public health degree, certificate, or education in public health. This represents roughly four of

every five employees in public health. Without well-trained public health professionals in various shortage disciplines, communities are left vulnerable to increased infectious diseases, toxic

environmental situations, contaminated food, and other threats to public health. Training for

public health professionals is critically important in medically underserved communities, where

serving disadvantaged populations is critical. There are only 2,755 physicians trained in general

preventive medicine and public health in the nation. The number of physicians completing a

preventive medicine residency has declined by 25 percent during the last 5 years leading to

major gaps in preventive medicine expertise need for clinical prevention, community public

health, and health services organization/delivery. DHHS programs are designed to address the

problems identified above. The public health traineeships provide support for students in shortage disciplines including epidemiology, biostatistics, environmental health, toxicology, public

health nursing, public health nutrition, preventive medicine, behavioral sciences and mental

health. The preventive medicine and dental public health programs support planning, development or maintenance of residency programs and provide financial assistance to residency trainees enrolled in these programs.

ASPH REQUEST

CDC currently funds 24 prevention research centers at schools of public health

and schools of medicine across the country. Each center has a specific prevention

research focus, based largely upon its faculty expertise and geographic location.

However, core funding for prevention centers has been decreasing since the program

was first funded in 1986 from an average of approximately $800,000 per center to

the current year average of approximately $715,000 per center. ASPH requests that

the Congress increase the funding for this important program from the current year

level of $25 million to $40 million. These funds will be used for the following purposes: to increase the core funding of centers such that the average core award is

$1 million (as intended by the Congress) which would allow CDC the flexibility to

provide additional funding to centers which have undertaken a more aggressive program; to provide sufficient resources to permit not more than six new, competitivelyselected centers; and to provide the necessary resources for administration of an expanded program at CDC.

Each prevention research center (PRCs) taps into the long-standing links that

schools of public health have with their communities and regions. Schools of public

health faculty work closely with community leaders in designing and applying prevention strategies and programs that address the public health challenges facing

these communities.

From Appalachia, Harlem, the Deep South, the Midwest, the Northwest and the

Southwest, the PRCs link diverse and geographically distinct areas through a national network that tracks and translates prevention research and best practices to

applications in community-based public health and disease prevention programs. Increasing funds for prevention research centers in fiscal year 2002 will enable them

to expand community-based interventions further into communities, allowing wider

access to lifesaving research and interventions.

HEALTH PROFESSIONS TRAINING (HRSA/BHPR)

The Association of Schools of Public Health respectfully requests that Congress provide at least $20 million for public health training programs and preventive medicine residencies in the fiscal year 2002 appropriations bill. Of this amount, $10 million should support public health traineeships and preventive medicine residencies

and $10 million should be dedicated to public health training centers at schools of

public health.

The Pew Health Professions Commission, in its 1995 report entitled Critical Challenges: Revitalizing the Health Professions for the Twenty-First Century, concluded

that the demand-driven system in health care will result in increased demand for

public health professionals as managed care organizations seek to hold health care

costs down by employing public health solutions to community problems.

Several public health workforce experts in both government and academia estimate that as many as 80 percent of individuals currently working in state or local

health departments have no formal education in pubic health. Furthermore, those

same experts estimate that less than 50 percent of the directors of the local health

departments, many of whom are MDs, have no public health training. There is a

critical need to provide these professionals with the most up-to-date public health

training available.

DHHS has listed personnel shortages in several public health occupations.1 Many

state/local health department directors have reported that the lack of practical

knowledge and skills in the core sciences of public health and preventive medicine

have restricted the effectiveness of their agencies. In order to improve the quality
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of the American public health infrastructure, we must provide adequate training,

education and continuing education to the public health workforce.

Many national health groups—especially the maternal and child health agencies

and state/local health officials—agree that regional shortages of adequately trained

professionals present the most significant barrier to providing population-based prevention initiatives, in general, and ensuring the delivery of quality health care to

underserved individuals and underrepresented populations, in particular. Health

professionals trained to handle the unique demands of rural and inner-city public

health issues are in the shortest supply.

ASPH REQUEST

The Association of Schools of Public Health (ASPH) is requesting that the fiscal

year 2002 HRSA budget include $20 million for public health workforce training.

Specifically, funding should be targeted to:

—Make public health/preventive medicine education more accessible;

—Create links between public health/preventive medicine education and future

trends in the practice of public health;

—Continued efforts to promote diversity in student populations;

—Provide education or training for students and preventive medicine residents in

practice-based sites instead of solely in the classroom; and

—Develop educational methods and distance-based learning technologies that ensure the ability of public health workers to reach underserved populations.

RESPONDING TO BIOTERRORIST ATTACK

Public Health Preparedness Centers

Building upon an fiscal year 2000 investment of $2 million and report language

urging continuation of the program in fiscal year 2001 to conduct training for current state and local health department employees, the Congress should include $10

million in CDC’s budget to continue public health education programs using distributed learning technologies with the goal of training employees of state and local departments of public health and community-based organizations to detect, contain

and respond to a bioterrorist attack. Such an action would also provide critically

needed training in the area of infectious diseases as well.

The recent focus on a bioterrorist attack on the United States has led many to

question the ability of the current public health workforce to deal with such an

emergency. There has not been a case of smallpox, for example, since the early

1970s—and few public health professionals are trained to recognize the symptoms

of this deadly disease. This lack of formal training in infectious diseases extends to

other biological agents such as anthrax, tularemia, botulinin toxin and plague. In

order to detect and respond to a bioterrorist attack, the U.S. needs public health

professionals who:

—Can conduct epidemiological surveillance;

—Can design and use the tools to detect terrorist biological attacks; and

—Understand the principles of containment.

ASPH REQUEST

We respectfully request that the Subcommittee include a total of $10 million in

the fiscal year 2002 CDC budget to provide for professional workforce development

services to public health and community-based organization employees in order to

detect and respond to a bioterrorist attack. It is proposed that CDC select not more

than ten public health preparedness centers based at accredited schools of public

health to conduct distance learning and professional workforce development activities. Outcomes of these programs would include:

—Offering high-level, in-depth biodefense and infectious disease training to approximately 500 public health professionals in state and local leadership positions (including large cities and state departments of health) using the Internet

and other distance learning technologies;

—Offering basic biodefense and infectious disease training to roughly 1,000 stafflevel public health officers (such as surveillance officers) through distance learning;

—Assessing the skills and readiness of public health workers to respond to bioterrorist and other public health threats;

—Developing a comprehensive public health training curriculum focused on detection and response to bioterrorist attacks to be delivered through the Internet,

or other appropriate mass communication technology.
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PREVENTION RESEARCH INITIATIVE (PRI)

Prevention research plays a critical role in reducing the human and economic

costs of disease. For example, the CDC has estimated that the annual cost of cardiovascular disease in the U.S. is approximately $259 billion, cancer is estimated to

cost $104 billion, diabetes is estimated at $92 billion, Alzheimer’s disease—approximately $80 billion, and arthritis about $65 billion. However, these costs can be reduced through prevention.

The benefits of population-based prevention are astounding. The Journal of the

American Medical Association published a widely accepted article in 1993 that estimates that ten percent of all early deaths in this country can be prevented by medical treatment. By contrast, the study found that population-wide public health approaches have the potential to prevent up to 70 percent of these early deaths

through measures that target underlying risks, such as tobacco, drug and alcohol

use, diet and sedentary lifestyle, and environmental factors.

ASPH REQUEST

The Association of Schools of Public Health respectfully requests that the Congress increase the funding for the CDC prevention research initiative to $25 million

in the fiscal year 2002 Labor, HHS and Education appropriations bill. Such a program should focus on conducting priority research in the following areas:

—Investigations into the epidemiology of disease, including identification of social

and behavioral determinants of illness;

—Studies of means to ameliorate personal, social and environmental factors contributing to disease onset or exacerbation;

—Investigations into the disproportionate disease burden among underserved populations;

—Studies of vulnerable populations with a high disease burden;

—Studies on immunization strategies and of methods for and the cost-effectiveness of population screening programs; and

—Studies into the means by which further decline in physical or social functioning can be prevented in people already ill.

Finally, the program would serve to expand the capacity of CDC to bring the benefits of prevention to the millions of Americans at risk for unnecessary early death.

SUMMARY

In closing, we are spending billions of dollars on treatment of chronic diseases

and/or research to find cures for such diseases, while at the same time using pennies of our health care dollars to find ways to prevent them. For example, the U.S.

Government spends approximately $50,000 per year/per capita to train medical

graduates; by contrast, the federal share per year to train graduate public health

students in the United States is less than ten dollars per student.

Our training programs in schools of public health are focused on prevention of disease and disability; our programs are steeped in the basic public health sciences of

epidemiology and biostatistics; and our curricula have a population-based perspective. In short, our graduates will be more likely to approach their jobs with a better

understanding of disease in populations and with keener sense of a whole spectrum

of interventions aimed at the environment, human behavior and lifestyle. Federal

support of these programs is a wise investment in the health of the American people.

In addition to our requests, the ASPH wishes to go on record in support of the

fiscal year 2002 appropriations recommendations of the following groups and coalitions that have or will submit testimony before the Subcommittee:

—Ad Hoc Group for Medical Research Funding

—CDC Coalition

—Coalition for Health Funding

—Friends of AHRQ

—Friends of NIOSH

—Friends of Title V (MCH Block Grant)

—Health Professions and Nursing Education Coalition

—Injury Control and Research Centers Coalition

—Friends of NCHS

In addition, we want to express the support of ASPH for providing $250 million

to upgrade laboratory facilities at CDC. These facilities are in desperate need of renovation.

ASPH requests, and those outlined by these coalitions, represent needs assessments that were derived from the views and expert opinions of this country’s most
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respected administrators, scholars, scientists and leaders in the public health sector.

We know that the Subcommittee members will take them into serious consideration

when marking-up the fiscal year 2002 appropriations bill.

Listed below are the ASPH fiscal year 2002 funding recommendations for programs of primary concern to the academic public health community:

[In millions of dollars]

CENTERS FOR DISEASE CONTROL AND PREVENTION:

Prevention Research Centers (PRCs) ............................................................ 40

Prevention Research Initiative (PRI) ............................................................ 25

Preparedness Centers (PHPCs) ..................................................................... 10

HEALTH RESOURCES AND SERVICES ADMINISTRATION:

Public Health Training Centers, Traineeships, Preventive Medicine and

Dental Public Health .................................................................................. 20

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PREPARED STATEMENT OF THE UNIVERSITY OF CINCINNATI

Mr. Chairman and Members of the Subcommittee, my name is Dr. Donald Harrison, and I am the Senior Vice President and Provost for Health Affairs at the University of Cincinnati. As CEO of the Medical Center, I am also administratively responsible for the University’s participation in the Health Alliance of Greater Cincinnati and for the academic programs of the Colleges of Medicine, Nursing, Pharmacy, and Allied Health Sciences. I am a practicing cardiologist with an international patient base, and I have served as national president of the American

Heart Association and Vice President of the American College of Cardiology.

I am here today on behalf of a coalition of 20 academic health centers across the

nation to highlight issues of concern to all academic health centers in the United

States. We are the institutions which conduct a significant portion of the extramural

biomedical and behavioral research funded through the National Institutes of

Health, and I welcome this opportunity to comment on the programs and policies

which seek to strengthen the nation’s extramural research enterprise.

First, I would like to thank all of the Members of this Subcommittee for the outstanding support provided to the NIH over the past several years. The additional

funds clearly have a significant impact the causes, prevention and treatment of

health problems which afflict the citizens of our nation and the world.

Second, I would like to thank the Subcommittee for successfully raising the salary

cap imposed on extramural NIH researchers to Level One of the Executive Pay

Scale, or $161,200 per year. This higher salary level allows academic medical centers to attract and retain the most talented individuals to biomedical and behavioral

research, especially clinician-investigators. Further, the higher salary cap assures

equity between intramural and extramural scientists. Because of your leadership,

extramural salaries will now be equal to the maximum salary level which the NIH

can pay its own senior scientists under the Senior Biomedical Research Service.

I would like to take this opportunity to request your support for further enhancing

the extraordinary partnership that was established with great foresight years ago

between academic institutions and the Federal Government. This partnership has

spawned remarkable scientific developments over decades. These advances position

us—academia, industry, and the government—to work together to exploit the golden

era of biology. Academic institutions across the nation are proud to be major players

in this partnership.

INCREASED FUNDING FOR NIH

As we look ahead to fiscal year 2002, I would like to begin by expressing the support of academic medical centers, and the extramural research community, to seek

a $3.4 billion or 16.5 percent increase for the NIH this year to bring the agency’s

budget to $23.7 billion for fiscal year 2002. This level of support will keep efforts

on track to double the NIH’s budget by fiscal year 2003. This is an incredible time

in biomedical history as the mapping of the human genome has been successfully

completed just last month. This extraordinary accomplishment presents an exponential number of additional opportunities to investigate the causes of disease and

will lead to new roads of inquiry to developing cures. In addition—and I will repeat

a statistic that I am sure you are all very aware—the NIH currently funds fewer

than four of every 10 approved research grants. All of these are judged by peer-review to merit funding because of their potential for biomedical advance. For these
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reasons, I urge you to continue efforts to increase the NIH’s budget toward the goal

of doubling the agency’s budget by fiscal year 2003.

Having raised the need to continue to increase funding for the NIH, I would like

to bring to your attention several factors that impact the ability of our institutions

to carry out the extramural component of our nation’s expanding and thriving biomedical research enterprise. Our institutions bear certain costs for conducting NIH

research that are not supported by the federal research dollar. In fact, all institutions, either public or private, bear a portion of the research expense. I am here

today to advocate that we further strengthen the academic/federal partnership so

that the extramural biomedical and behavioral research community can operate at

optimal capacity and efficiency: Specifically, I urge you to:

—Increase extramural construction funding so that NIH investigators can utilize

state-of-the-art facilities to carry out the increasing volume of federally-supported biomedical and behavioral research; and

—Provide resources to research institutions in order to comply with the increasing

costs of federal regulation.

In addition, I seek your support for increased funding through the Agency for

Healthcare Research and Quality for technological support to combat medical errors.

This problem has been highlighted in a review by the Institute of Medicine and in

numerous media reports.

INCREASE FUNDING FOR FACILITIES CONSTRUCTION, RENOVATION, AND EQUIPMENT

For the past two years, the NIH has included $75 million in extramural construction funding through the NIH’s National Center for Research Resources (NCRR).

These funds are necessary for extramural researchers to have adequate laboratories

in which to conduct this important research. It is vitally important that we have

the facilities and equipment to fully exploit research opportunities and utilize the

increased project grant funding. Exciting developments in genomics, chemical biology, neurosciences, cancer, and many other fields require new kinds of equipment

and facilities. Even the best minds cannot compensate for outdated equipment and

facilities.

The National Science Foundation (NSF) completed a study in 1998 on the status

of scientific research facilities at U.S. colleges and universities. This analysis generated an estimate of $11.4 billion in deferred biomedical research construction and

repair or renovation projects. In a March 1998 report, the Association of American

Medical College (AAMC) stated that ‘‘The government should reestablish and fund

an NIH construction authority, consistent with the general recommendations of the

Wyngaarden Committee report of 1988, which projected at that time the need for

a 10-year spending plan of $5 billion for new facilities and renovation.’’ In June

1998, the Federation of American Societies of Experimental Biology (FASEB) reported that ‘‘Laboratories must be built and equipped for the science of the 21st

Century. Infrastructure investments should include renovation of existing space as

well as new construction, where appropriate.’’ We have reached a period where the

useful life of our research facilities fail to meet the needs of modern technology and

in many instances do not meet regulatory standards.

While the research community commends the Subcommittee for providing $75

million for extramural facility construction last year, there is a clear and documented need for several billion dollars to rectify this situation. For this reason, we

urge the Subcommittee to provide a funding level of $250 million for extramural

construction in fiscal year 2002. The funds would be awarded on a peer-reviewed,

competitive basis—requiring institutional matching funds to leverage NIH resources.

INCREASING COSTS OF COMPLYING WITH FEDERAL REGULATIONS

Another issue of significant concern to academic medical centers is the increased

costs to research institutions for complying with research-related federal regulations. While extramural researchers have always been subjected to certain federal

regulations, the increasing number of administrative requirements imposed on institutions has resulted in escalating costs. In recent years, institutions have been required to take additional measures to comply with more frequent institutional review boards, privacy regulations, human subject and animal protections—to name

just a few. Let me reiterate that researchers are not opposed to providing these safeguards and do not question the necessity of these measures. We are, however, concerned about the costs of complying with these mandates, many of which are constantly changing. Last year the nonprofit RAND institute published a report titled

‘‘Paying for University Research Facilities and Administration.’’ The report notes

that compliance costs affect both facilities and administrative components, and fur-
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ther states ‘‘increasingly sophisticated regulations have required new specialized

personnel.’’ The RAND report further provided the following impact on an unnamed

institution:

‘‘. . . compliance with facilities requirements necessitates so many improvement

projects for existing facilities that is infeasible to undertake them all at once. This

university has committed $1.2 million per year, indefinitely, for facilities improvements to enhance compliance with hazardous waste, occupational safety, animal

care, and other facilities regulations . . . This is only a partial estimate of the costs

of compliance. This estimate does not include the costs of compliance associated

with major building renewal of new construction projects that the university undertakes. Neither does it include the costs of administrative oversight each year to

track compliance, train people, and make reports’’.

FASEB, in its recommendations for federal funding for biomedical and related life

sciences funding for fiscal year 2002, specifically advocates ‘‘that NIH, other federal

agencies and the biomedical research community address growing administrative

costs associated with increased regulation, such as for human subjects protection

and animal care. These costs should be fully funded by the sponsoring agency.’’

Researchers at academic medical centers join reiterate the concern raised by our

colleagues in FASEB that federal agencies sponsoring biomedical and behavioral research should provide adequate funds for institutions to comply with the necessary

regulations associated with conducting federal research. In my own institution, we

have had to add more than five new staff to meet recently enacted regulations. Our

interaction with federal agencies responsible for these has increased several-fold.

TECHNOLOGICAL INFRASTRUCTURE TO ADDRESS MEDICAL ERRORS

Lastly, I would like to commend the Subcommittee for providing $50 million in

last year’s Labor/HHS Appropriations bill through the Agency for Healthcare Research and Quality to determine ways to reduce medical errors. This funding was

provided consistent with S. 2038, the medical Error Reduction Act of 2000, which

was introduced by Senators Arlen Specter, Tom Harkin and Daniel Inouye. This legislation sought to establish a competitive demonstration program for health care facilities and organizations to test best practices for reducing errors. As institutions

with large clinical programs, we are, of course, interested in reducing the incidents

of medical errors within our institutions. We seek additional funding for this program to provide our institutions with adequate resources to utilize or upgrade technological infrastructure to reduce the incidence of medical errors.

CONCLUDING REMARKS

Mr. Chairman, polls conducted by Research!America—including polls in my State

of Ohio—reflect the fact that the American public strongly supports our federal investments in biomedical and behavioral research. We believe that NIH’s extramural

research enterprise would significantly benefit if institutions were provided with additional resources, including $250 million to upgrade extramural laboratory space

and instrumentation, and additional funding to address the increased administrative costs associated with regulatory compliance. In addition, we support additional

funding through the Agency for Healthcare Research and Quality for technological

infrastructure so that our institutions can reduce medical errors.

Each of these steps will increase the productivity and efficiency of the academic/

government partnership in biomedical and behavioral research and research training. On behalf of academic health centers across the nation, I thank you for your

attention to these needs and recommendations. Best wishes to each of you.

PREPARED STATEMENT OF THE AMERICAN ACADEMY OF FAMILY PHYSICIANS

The 93,000 member American Academy of Family Physicians is pleased to submit

this statement for the record on three issues of critical importance to family physicians in the United States: (1) funding for family medicine training in Section 747

of the Public Health Service Act; (2) funding for the Agency for Healthcare Research

and Quality (AHRQ); and (3) funding for rural health programs. The Academy is

the professional organization representing practicing family physicians, residents

and medical students.
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FAMILY MEDICINE TRAINING PROGRAMS

Recommendation

The American Academy of Family Physicians supports appropriations of $158 million for Section 747 of Title VII of the Public Health Service Act for fiscal year 2002.

Section 747 authorizes the Primary Care and Dentistry cluster, which includes support for family medicine, general internal medicine and general pediatrics, physician

assistants and general and pediatric dentistry. This figure includes $96 million for

family medicine programs. In fiscal year 2001, Section 747 received $91 million, a

17 percent increase over last year’s funding level of $78.3 million.

Section 747 is the only program at the federal level that supports four family

medicine training programs at both the undergraduate and graduate level: residency training; academic departments; predoctoral programs and faculty development. Section 747 is crucial to training the physicians that America needs most; it

is the engine that powers the growth of this nation’s supply of family physicians.

Title VII Grants to Medical Schools Induces Physicians to go into Primary Care

A recent, unpublished study by the Robert Graham Policy Center for Policy Studies showed that the receipt of Section 747 family medicine funds by a medical school

made a significant difference on whether medical students ultimately (1) practiced

in family medicine or primary care (defined as family physicians, general practitioners, general internists or general pediatricians), (2) practiced in a rural area, or

(3) practiced in a whole county primary care health professions shortage area.

—All three types of grants (departments of family medicine, predoctoral medical

education programs, and faculty development programs) made a difference in

producing more family physicians, and more primary care doctors.

—Predoctoral and department development grants made a difference in producing

more primary care doctors serving in rural areas, and more primary care doctors serving in primary care health professional shortage areas.

—Sustained funding during the years of medical school training had more positive

impact than intermittent funding.

Due to Section 747 funding, thousands of physicians are making career choices

to go into primary care and family medicine and to serve millions of patients. Without Section 747 funding, fewer students would be making these career choices.

The United States Relies on Family Physicians Unlike any other Physicians

Another recent study by the Robert Graham Center showed that the United

States relies on family physicians more than any other physician specialty. Specifically, the study looked at counties designated as Primary Care Health Professions

Shortage Areas, those counties that have inadequate numbers of family physicians,

general pediatricians, general internists or obstetrician/gynecologists. Currently,

there are 3,082 counties in the United States; 784 qualify as Primary Care HPSAs.

The study found that:

—If family physicians were to be withdrawn from all 3,082 counties, an additional

1,332 counties would become Primary Care HPSAs.

—In contrast, if all internists, pediatricians and obstetrician-gynecologists were to

be taken out of the nation’s counties, only another 176 would become shortage

areas. Without family physicians, counties around the United States would not receive

essential primary care services.

Turning Around the Shortage of Family Physicians

There is a shortage of family physicians and other primary care physicians (general internists and general pediatricians) in the United States. Numerous experts,

including the Physician Payment Review Commission; the Council on Graduate

Medical Education; the Robert Wood Johnson Foundation; the Pew Health Professions Commission; the American Medical Association and the Association of American Medical Colleges have called for increasing the supply of primary care physicians for quality, access and cost reasons. Most experts believe a physician workforce with a 50/50 ratio between primary care physicians and subspecialists would

best meet America’s health care needs; the ratio is currently approximately 30/70.

Section 747 family medicine grants have helped establish an infrastructure

throughout the country that has reversed the downward trend in primary care.

While at one time, the United States physician workforce was comprised of more

than 50 percent primary care physicians, it declined after World War II to approximately 30 percent today. The Section 747 family medicine training programs provided funds to establish family medicine departments in medical schools; to increase

the number of faculty to both teach and act as role models, and to set up new

residencies throughout the country.
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Market Demand for More Family Physicians

The demand for family physicians in the market is greater than our nation’s current training capacity. Medicare payment policies have contributed to the increase

in subspecialist physicians and have fundamentally skewed the market. These policies have promoted training in the expensive inpatient specialties—rather than in

family medicine and other primary care fields. Moreover, NIH grants, totaling billions of dollars, go primarily to subspecialist research in the nation’s medical education complexes.

Primary Care Doctors are Cost Effective

Numerous studies show that primary care physicians are more cost-effective due

to their prudent use of hospital services, tests and procedures. A September, 1995,

study conducted by KPMG Peat Marwick, The Role of Primary Care Physicians in

Controlling Health Care Costs: Evidence and Effects, indicated that Medicare spending could be cut by at least $48.9 billion and as much as $271.5 billion over the

next six years if primary care physicians were 50 percent of the total physician

workforce.

Community Training Requires Support

In contrast to other specialties, 80 percent of family practice residencies are located in community settings rather than in major tertiary care teaching hospitals.

These residencies provide more ambulatory training than any other residencies. As

a result, family practice programs do not have access to the considerable resources

that flow to teaching hospitals. Further, 25 percent of family practice residencies are

located in public hospitals. These hospitals receive a low reimbursement for patient

care services, and treat fewer Medicare patients. As a result, they do not receive

substantial Medicare graduate medical education dollars.

Acute Shortage of Faculty

There is an acute shortage of faculty for family medicine residency programs and

family medicine departments. The discipline has been successful at placing its graduates in practice settings serving communities of need rather than in full-time faculty positions. Without adequate funding, there is a risk that even the progress that

has been made so far will be compromised for lack of faculty.

Title VII and Graduate Medical Education

Title VII health professions programs are separate and distinct from graduate

medical education (GME). Title VII is a Public Health Service program and funding

goes to medical schools, universities and residency programs to develop a primary

care infrastructure. Graduate medical education is part of the Medicare program

and funds go primarily to hospitals to support residency training.

The Academy has had a long-standing interest in graduate medical education because of our commitment to a rational physician workforce policy that both discourages an oversupply of physicians and encourages increased training of those physician specialties in short supply. Our organization has produced and updated a number of policies on physician workforce issues, as well as specific GME recommendations. However, without a major overhaul of the physician workforce in the United

States that would address the primary care issues targeted by Title VII funding, it

is imperative to support these programs.

Innovative Programs

Title VII funds are used to support innovative new programs that help training

and teaching programs simply get better, a goal that often involves new technologies. Innovative programs can include web-based technologies to evaluate training programs, or even establish links to primary care research networks. Grant recipients are using Title VII dollars to leverage dollars not only to meet the traditional goals of diversity, outreach to the underserved and rural populations, but also

to new programs that use key technologies.

Additional Outcomes Data

There have been several articles that have specifically described the value of Title

VII family medicine programs.

—An October, 1994 General Accounting Office (GAO) report indicated that ‘‘students who attended medical schools with family medicine departments were 57

percent more likely to pursue all three primary care disciplines (italics added).’’

In addition, the 1994 GAO report indicated that ‘‘students who attended schools

requiring a third-year family practice clerkship were 18 percent more likely to

pursue primary care.’’
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—A November/December, 1997, article in the Archives of Family Medicine found

a strong relationship between continued Title VII funding and the presence of

family medicine departments, which is associated with greater rates of primary

care production. (The Impact of Title VII Departmental and Predoctoral Support

on the Production of Generalist Physicians in Private Medical Schools, Robert

M. Politzer, ScD, et. al.)

—Family physicians have deep roots in rural communities, where 25 percent of

all Americans live. About one-quarter of family physicians locate there, as well.

The February, 1998, Tenth Report of the Council on Graduate Medical Education (COGME) stated that, ‘‘Programs authorized under Title VII of the Public

Health Service Act support family medicine programs with a successful record

of training physicians who choose to practice in rural and underserved areas.

These efforts should be continued and increased.’’

The goals stipulated by Congress in the Title VII reauthorization bill emphasize

both the delivery of health services to underserved populations and the geographic

distribution of health professionals to underserved, particularly rural, areas. These

congressionally mandated goals are fully addressed by the Title VII programs, and

for family medicine, all four program areas have been extremely successful.

In addition, another Congressional priority is to enhance the diversity of our medical workforce. In 1978, the first year for which we have data, the number of minority residents in training in family practice residency programs was 9.5 percent. By

1997, that rate had increased to 24 percent.

Finally, over 90 percent of physicians who complete family practice residency programs work in direct primary patient care and are able to handle a high percentage

of their patient’s problems.

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

Recommendation

The American Academy of Family Physicians recommends appropriations of $400

million for the Agency for Healthcare Research and Quality (ARHQ) in fiscal year

2002. We strongly support the Agency because of its emphasis on primary care and

practice-oriented research. It is the only federal agency with this charge. In fiscal

year 2001, the Agency for Healthcare Research and Quality (AHRQ), received

$269.9 million, a 36 percent increase above the current funding level of $198.76 million.

What is Primary Care Research?

Primary care research includes (1) research on the conditions that affect the majority of the population, and (2) translating biomedical research into practice.

Additional research is needed on conditions that affect most Americans. Most

medical care is provided in outpatient settings. However, ambulatory medicine is

the least researched mode of patient care. While over 95 percent of all medical conditions have been evaluated and treated outside of hospitals over the last 30 years,

physicians are educated and trained using research that has been derived mainly

from hospitalized patients, or patients with rare conditions. Primary care physicians

who diagnose and treat patients before they need hospital care operate without the

level of research available to their subspecialist colleagues.

It is not enough to develop new treatments; they must also be implemented and

result in better patient outcomes. American medicine is praised worldwide for its

excellence in biomedical research. However, while we have invested heavily in new

technologies, drugs and procedures, they are seen increasingly as costly advances

for potentially modest gains. Greater gains may be possible if we can invest more

heavily in finding ways to bring state-of-the art medicine to community medical

practices.

Primary Care Research Agenda

A primary care research agenda should include at least six basic categories for

study. (The agenda is further described in the AHRQ report, Putting Research into

Practice: Report of the Task Force on Building Capacity in Primary Care, 1993.) Included in this agenda should be research on:

—the origin of disease and the loss of health;

—improvements in diagnostic accuracy;

—appropriate treatments;

—improvements in the physician-patient relationship;

—improvements in health care delivery;

—improvements in patient satisfaction.
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Examples of Primary Care Research Needs

Primary care research is needed to provide information to physicians on the most

effective treatment plans for patients with numerous, serious conditions. An example of this situation is a single patient with diabetes, hypertension, depression, low

back pain and heart disease. Traditional, disease-specific treatment is not useful in

this situation; treatment for one disease may exacerbate the other conditions.

Research is also needed on differentiating the common headache that affects 20

million Americans from one with serious implications. While headaches afflict millions of individuals, the primary care physician has little information on how to

identify the few who suffer from life-threatening illness.

IOM Recommendation on Funding Needed for Primary Care Research

According to the 1996 Institute of Medicine (IOM) report on primary care, Primary Care: America’s Health in a New Era, federal investments in primary care research today total between $15 and $20 million annually. The IOM report recommended an immediate fourfold increase in primary care research.

RURAL HEALTH PROGRAMS

Finally, the Academy supports continued funding for several rural health programs. In particular, we support the programs of the Federal Office of Rural Health

Policy; Area Health Education Centers, two programs that are equally important to

health care in rural areas and in our inner cities; the Community and Migrant

Health Center Program and the National Health Services Corps. State rural health

offices, funded through the National Health Services Corps budget, help States implement such programs so that they benefit rural residents as much as urban dwellers. Continued funding for these rural programs is vital if we wish to provide adequate health care services to America’s rural citizens.

CONCLUSION

Thank you for your consideration of these important requests.

PREPARED STATEMENT OF THE AMERICAN ACADEMY OF PHYSICIAN ASSISTANTS

On behalf of the 41,000 clinically practicing physician assistants in the United

States, the American Academy of Physician Assistants is pleased to submit comments on fiscal year 2002 appropriations for Physician Assistant (PA) education programs that are authorized through Title VII of the Public Health Service Act.

A member of the Coalition for Health Funding (CHF), the American Academy of

Physician Assistants supports the CHF recommendation to appropriate $44.285 billion for the Public Health Service in fiscal year 2002. The Academy is also a member of the Health Professions and Nursing Coalition (HPNEC) and supports the

HPNEC recommendation to provide at least $440 million to support the Titles VII

and VIII programs in fiscal year 2002. The Academy believes that the recommended

increase in funding for the Title VII health professions programs is well justified.

The programs are essential to the development and training of primary health care

professionals and contribute to the nation’s overall efforts to increase access to care

by promoting health care delivery in medically underserved communities.

The Academy is very concerned with the Administration’s proposal to reduce fiscal

year 2002 funding for the Titles VII and VIII programs. As Members of the Subcommittee are aware, these programs are designed to help meet the health care delivery needs of the nation’s Health Professional Shortage Areas (HPSAs). By definition, the nation’s 2,800 HPSAs experience shortages in the primary care workforce

that the market alone can’t address. We wish to thank the Members of this Subcommittee for your historical role in supporting funding for the health professions

programs, and we hope that we can count on your support for these important programs in fiscal year 2002.

OVERVIEW OF PHYSICIAN ASSISTANT (PA) EDUCATION

PA programs provide students with a primary care education that prepares them

to practice medicine with physician supervision. Physician assistant programs are

located at schools of medicine or health sciences, universities, teaching hospitals,

and the Armed Services. All PA educational programs are intensive education programs that are accredited by the Accreditation Review Commission on Education for

the Physician Assistant.

The typical PA program consists of 111 weeks of instruction. The first phase of

the program consists of intensive classroom and laboratory study, providing stu-
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dents with an in-depth understanding of the medical sciences. More than 400 hours

in classroom and laboratory instruction are devoted to the basic sciences, with over

70 hours in pharmacology, more than 149 hours in behavioral sciences, and more

than 535 hours of clinical medicine.

The second year of PA education consists of clinical rotations. On average, students devote more than 2,000 hours or 50–55 weeks to clinical education, divided

between primary care medicine and various specialties, including family medicine,

internal medicine, pediatrics, obstetrics and gynecology, surgery and surgical specialties, internal medicine subspecialties, emergency medicine, and psychiatry. During clinical rotations, PA students work directly under the supervision of physician

preceptors, participating in the full range of patient care activities, including patient

assessment and diagnosis, development of treatment plans, patient education, and

counseling.

Physician assistant education is competency based. After graduation from an accredited PA program, the physician assistant must pass a national certifying examination jointly developed by the National Board of Medical Examiners and the independent National Commission on Certification of Physician Assistants. To maintain

certification, PAs must log 100 continuing medical education credits over a 2-year

cycle and reregister every two years. Also to maintain certification, PAs must take

a recertification exam every six years.

PHYSICIAN ASSISTANT PRACTICE

Physician assistants are licensed health care professionals educated to practice

medicine as delegated by and with the supervision of a physician. In all states, physicians may delegate to PAs those medical duties that are within the physician’s

scope of practice and the PA’s training and experience, and are allowed by law.

Forty-seven States, the District of Columbia, and Guam authorize physicians to delegate prescriptive privileges to the PAs they supervise.

PAs are located in almost all health care settings and in every medical and surgical specialty. Fourteen percent of all PAs practice in rural areas where they may

be the only full-time providers of care (state laws stipulate the conditions for remote

supervision by a physician). Approximately twenty percent of PAs work in urban

and inner city areas. The majority of PAs are in primary care. Nearly one-quarter

practice in surgical specialties. Seventy percent of PAs practice in outpatient settings. In 2000, an estimated 161 million patient visits were made to PAs and approximately 202 million medications were prescribed or recommended by PAs.

CRITICAL ROLE OF THE TITLE VII, PUBLIC HEALTH SERVICE ACT, PROGRAMS

A growing number of Americans lack access to primary care, either because they

are uninsured, underinsured, or they live in a community with an inadequate supply or distribution of providers. The growth in the uninsured U.S. population increased from approximately 32 million in the early 1990s to over 42 million today.

Simultaneously, the number of medically underserved communities continues to

rise, from 1,949 in 1986 to 2,800 today.

The role of the Title VII programs is to alleviate these problems by supporting

access to quality, affordable, and cost-effective care in areas of our country that are

most in need of health care services, specifically rural and urban underserved communities. This is accomplished through the support of educational programs that

train more health professionals in fields experiencing shortages, improve the geographic distribution of health professionals, and increase access to care in underserved communities.

The Title VII programs are the only federal education programs that are designed

to address the supply and distribution imbalances in the health professions. Since

the establishment of Medicare, the costs of physician residencies, nurses and some

allied health professions training has been paid through Graduate Medical Education (GME) funding. However, GME has never been available to support PA education. More importantly, GME was not intended to generate a supply of providers

who are willing to work in the nation’s medically underserved communities. That

is the purpose of the Title VII Public Health Service Act Programs, which support

such initiatives as loans and scholarships for disadvantaged students, scholarships

for students with exceptional financial need, centers of excellence to recruit and

train minority and disadvantaged students, and interdisciplinary initiatives in geriatric care and rural health care.

TITLE VII SUPPORT OF PA EDUCATION PROGRAMS

Targeted federal support for PA education programs is currently authorized

through section 747 of the Public Health Service Act. The program was reauthorized
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in the 105th Congress through the Health Professions Education Partnerships Act

of 1998, Public Law 105–392, which streamlined and consolidated the federal health

professions education programs. Support for PA education is now considered within

the broader context of training in primary care medicine and dentistry.

Public Law 105–392 reauthorized awards and grants to schools of medicine and

osteopathic medicine, as well as colleges and universities, to plan, develop, and operate accredited programs for the education of physician assistants and faculty, with

priority given to training individuals from disadvantaged communities. The funds

ensure that PA students from all backgrounds have continued access to an affordable education and encourage PAs, upon graduation, to practice in underserved communities. These goals are accomplished by funding PA education programs that

have a demonstrated track record of: (1) placing PA students in health professional

shortage areas; (2) exposing PA students to medically underserved communities during the clinical rotation portion of their training; and (3) recruiting and retaining

students who are indigenous to communities with unmet health care needs.

The program works. A review of PA graduates from 1991–1999 reveals that 16.5

percent of students graduating from PA programs supported by Title VII are from

underrepresented minorities, compared to 7.7 percent of graduates from programs

that did not receive Title VII support. Similarly, 13.5 percent of the graduates who

attended PA programs receiving Title VII support during the 8-year period practice

in underserved communities, compared to 10.1 percent of graduates of programs not

receiving such support during the same period.

The PA programs’ success in recruiting and retaining underrepresented minority

and disadvantaged students is linked to their ability to creatively use Title VII

funds to enhance existing educational programs. For example, a PA educational program in Iowa uses Title VII funds to target recruitment efforts to disadvantaged

students, providing shadowing and mentoring opportunities for prospective students, increasing training in cultural competency, and identifying new family medicine preceptors in underserved areas. PA programs in Texas use Title VII funds to

create new clinical rotation sites in rural and undersered areas, including new sites

in border communities, and to establish non-clinical rural rotations to help students

understand the challenges faced by rural communities. A PA program in Kansas has

used Title VII funds to provide a significant portion of the training for 500 PA students in remote, medically underserved communities in the state. Several other PA

programs have been able to use Title VII grants to leverage additional resources to

assist students with the added costs of housing and travel that occur during relocation to rural areas for clinical training.

Without Title VII funding, many of these special PA training initiatives would not

be possible. Institutional budgets and student tuition fees simply do not provide sufficient funding to meet the special, unmet needs of medically underserved areas or

disadvantaged students. Nevertheless, the need is very real, and Title VII is critical

in meeting it.

NEED FOR INCREASED TITLE VII SUPPORT FOR PA EDUCATION PROGRAMS

Increased Title VII support for educating PAs to practice in underserved communities is particularly important given the market demand for physician assistants.

Without the Title VII funding to expose students to underserved sites during their

training, PA students are far more likely to practice in the communities where they

were raised or the communities in which they attended school. Title VII funding is

a critical link in addressing the natural geographic maldistribution of health care

providers by exposing students to underserved sites during their training, where

they frequently choose to practice following graduation.

The supply of physician assistants is inadequate to meet the needs of society, and

the demand for PAs is expected to increase. A 1994 report of a workgroup of the

Council on Graduate Medical Education (COGME), ‘‘Physician Assistants in the

Health Workforce,’’ estimated that the anticipated medical market demand and the

estimated workforce requirements for PAs would exceed demand. Additionally, the

Bureau of Labor Statistics projects that the number of available PA jobs will increase 48 percent between 1998 and 2008.

Despite the increased demand for PAs, funding has not proportionately increased

for the Title VII programs that are designed to educate and place physician assistants in underserved communities. Nor has the Title VII support for PA education

kept pace with increases in the cost of educating PAs. A review of PA program budgets from 1984 through 1999 indicates an average annual increase of 7.2 percent, a

total increase of 173 percent over the past sixteen years; yet, federal support has

remained relatively static. The fiscal year 2001 increase in appropriations for Title

VII’s Cluster on Training in Primary Care Medicine and Dentistry, which includes
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funding for PA education, represented the first real increase in funding in nearly

a decade.

RECOMMENDATIONS ON FISCAL YEAR 2002 FUNDING

The American Academy of Physician Assistants urges members of the Appropriations Committee to consider the inter-dependency of all the public health agencies

and programs when determining funding for fiscal year 2002. For instance, while

it is important to fund clinical research at the National Institutes of Health (NIH)

and to have an infrastructure at the Centers for Disease Control (CDC) that ensures

a prompt response to an infectious disease outbreak, the good work of both of these

agencies will go unrealized if the Health Resources and Services Administration

(HRSA) is inadequately funded. HRSA administers the ‘‘people’’ programs, such as

Title VII, that bring the cutting edge research discovered at NIH to the patients—

through providers such as PAs who have been educated in Title VII-funded programs. Likewise, CDC is heavily dependent upon an adequate supply of health care

providers to be sure that disease outbreaks are reported, tracked, and contained.

The critically important programs administered by NIH, HRSA, and CDC are integral components within the nation’s public health continuum. One component is

not more important than another, and no one component can succeed without adequate support from each of the other elements. The Academy is particularly concerned that any increase for the NIH not be made at the expense of the health professions education program or other public health programs, as recommended this

year by the Senate Budget Committee.

The American Academy of Physician Assistants is particularly appreciative of the

increase in funding for PA education programs that was appropriated for fiscal year

2001. Yet, the increase is not sufficient to meet the increasing demand for PA graduates in the growing number of medically underserved communities. Accordingly,

the Academy respectfully requests that the Title VII health professions programs receive a 15 percent funding increase in fiscal year 2002, including $10 million to support PA educational programs.

Thank you for the opportunity to present the American Academy of Physician Assistants’ views on fiscal year 2002 appropriations.

PREPARED STATEMENT OF THE AMERICAN ASSOCIATION FOR GERIATRIC PSYCHIATRY

The American Association for Geriatric Psychiatry (AAGP) appreciates this opportunity to present its recommendations on issues related to fiscal year 2002 appropriations for mental health research and services. AAGP is a professional membership organization dedicated to promoting the mental health and well being of older

Americans and improving the care of those with late-life mental disorders. AAGP’s

membership consists of over 2000 geriatric psychiatrists as well as other health professionals who focus on the mental health problems faced by senior citizens.

AAGP would like to thank the Subcommittee for its continued strong support for

increased funding for the National Institutes of Health (NIH) over the last several

years, particularly the additional funding you have provided for the National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA). Although

we generally agree with others in the mental health community about the importance of sustained and adequate Federal funding for mental health research and

treatment, AAGP brings a somewhat unique perspective to these issues because of

the aged patient population served by our members.

There are serious concerns, shared by AAGP and researchers, clinicians, and consumers that there exists a critical disparity between appropriations for research,

training, and health services and the projected mental health needs of older Americans. This disparity is evident in the convergence of several key factors:

—demographic projections inform us that, with the aging of the U.S. population,

there will be an unprecedented increase in burden of mental illness among

aging persons, especially among the baby boom generation;

—this growth in the proportion of older adults and the prevalence of mental illness is expected to have a major direct and indirect impact on general health

service use and costs;

—despite the fact that effective treatment exists, the mental health needs of many

older adults remain unmet;

—a major gap exists between research and service delivery; and

—despite recent significant increases in appropriations for support of research in

mental health, the allocation of NIMH and the Center for Mental Health Services (CMHS) funds for research that focuses on mental health and aging is dis-
458

proportionately low, and woefully inadequate to deal with the impending crisis

of mental health in older Americans.

DEMOGRAPHIC PROJECTIONS AND THE DISPARITY IN RESEARCH FUNDING FOR MENTAL

DISORDERS OF AGING

As shown in Figure 1 (attached), the increase in the number of people over 65

years of age, combined with the increasing prevalence of psychiatric problems in

that segment of the U.S. population, will dramatically increase the proportion of

older adults with mental health disorders relative to younger adults. Furthermore,

older adults account for health care costs that are disproportionately greater than

their numbers. This figure also illustrates that the projected proportion of NIMH

funding for aging research (based on current funding trends) is drastically below

what will be needed to address the projected increase in mental health problems

among older persons over the coming decades.

With the ‘‘baby boom’’ generation nearing retirement, the number of older Americans experiencing mental problems is certain to increase in the future. By the year

2010, there will be approximately 40 million people in the United States over the

age of 65. Over 20 percent of those people will experience mental disorders. A national crisis in geriatric mental health care is emerging and has received recent attention in the medical literature. Action must be taken now to avert serious problems in the near future. While many forms of mental and behavioral disorders can

occur late in life, they are not an inevitable part of the aging process, and continued

research holds the promise of improving the mental health and quality of life for

older Americans.

Current and projected economic costs of mental disorders alone are staggering.

For example, the direct medical costs of caring for patients with Alzheimer’s disease

(many of whom are treated by geriatric psychiatrists) ranges from $18,000 to

$36,000 a year per patient, depending on the severity of the disease. In addition,

there are other expenses associated with caring for an Alzheimer’s disease patient

including social support, care giving, and often nursing home care. It is estimated

that total costs associated with caring for patients with Alzheimer’s disease is over

$100 billion per year. Psychiatric symptoms (including depression, agitation, and

psychotic symptoms affect 30 to 40 percent of people with Alzheimer’s and are associated with increased hospitalization, nursing home placement, family burden, and

over 20 percent greater costs over and above Alzheimer’s alone. Although NIA has

supported extensive research on the cause and treatment of Alzheimer’s, treatment
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of these behavioral and psychiatric symptoms has been neglected and should be supported through NIMH.

Depression is another example of a common problem among older persons. Of the

approximately 32 million Americans who have attained age 65, about five million

suffer from depression, resulting in increased disability, general health care service

use and costs, and increased risk of suicide. Approximately 30 percent of older persons in primary care settings have significant symptoms of depression; and depression is associated with greater health care costs, poorer health outcomes, and increased mortality. Older adults have the highest rate of suicide rate compared to

any other age group.

The enormous and widely underestimated costs of late life mental illnesses justifies major new investments. The personal and societal costs of mental illness and

addictive disorders are high, but advances in research and treatment will help save

lives, strengthen families, and save taxpayer dollars. While the funding increases

supported by this Subcommittee in recent years have been essential first steps to

a better future, a serious and sustained investment in research is necessary to allow

continuous progress on the many research advances we made to date. Toward that

end, we support the professional judgment of the mental health research advocacy

community that a 16.5 percent across-the-board increase in fiscal year 2002 funding

for NIH is warranted.

Commendable as recent funding increases for NIH and NIMH have been, AAGP

would like to call the Subcommittee’s attention to the fact that these increases have

not always translated into comparable increases in funding for extramural research

on mental health of the elderly. Data supplied to AAGP by NIMH indicates that

while extramural research grants by NIMH increased 59 percent during the 5-year

period from fiscal year 1995 through fiscal year 2000 (from $485,140,000 in fiscal

year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for aging research increased at less than half that rate: only 27.2 percent during the same period (from

$46,989,000 to $59,771,000).

Figure 2 (attached) shows that funding for aging mental health research is not

keeping pace with that of other adult mental health research, and is actually decreasing proportionally when considered in the context of anticipated projections in

growth of mental disorders in older persons. For example, the proportion of total

NIMH newly funded extramural research grant funding devoted to aging research

declined from an average of eight percent from fiscal years 1995 to 1999 to a low

of six percent in fiscal year 2000. It is likely that one reason for the decline in funding of new grants is due to the lack of grant review committees at NIMH with specific expertise in aging. Grant review committees with specialized expertise in geriatrics are needed to assure fair review of research proposals that take into account

knowledge of the unique biological factors associated with the aging brain, the universal presence of co-occurring medical disorders, and different nature of financing

and health service delivery for older Americans.
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THE BENEFITS OF RESEARCH ON PUBLIC HEALTH

The U.S. Surgeon General’s Report on Mental Health (1999) and the Administration on Aging Report on Older Adults and Mental Health (2001) underscore the

prevalence of mental disorders in older persons and provide evidence that research

supports the development of effective treatments. These publications by the Federal

Government recognize the increasing importance of late life mental illness on our

society. In addition, these reports summarize research findings showing that treatments are being developed and tested that are effective in relieving symptoms, improving functioning, enhancing quality of life, including preliminary findings suggesting that these interventions reduce the need for expensive and intensive acute

and long-term services. However, it is also well demonstrated that there is a pronounced gap between research findings on the most effective treatment interventions and implementation by health care providers. These reports stress the need

for translational and health services research focusing on identifying the most costeffective interventions, as well as creating effective methods for improving the quality of health care practice in usual care settings. A major priority (neglected to date)

is the development of a research agenda focusing on health services research on

mental health and aging that examines the effectiveness and costs of effective models of mental health service delivery for older persons.

Special attention also needs to be paid to investigations of inadequate, or poorly

studied, serious late-life mental disorders since illnesses such as schizophrenia, anxiety disorders, alcohol dependence and personality disorders have been largely ignored by both the research community and the funding agencies despite the fact

that these conditions take a major toll on patients, their care givers, and society at

large. Many of AAGP’s members are at the forefront of groundbreaking research on

Alzheimer’s disease, depression, and psychosis among the elderly, and we strongly

believe that more research funds must be focused in these areas. Improving the

treatment of late-life mental health problems will benefit not only the elderly, but

also their children, whose lives are often profoundly affected by those of their parents.

Perhaps one of the greatest costs of late-life mental illness is the physical and

emotional toll on family members, caregivers, and friends. AAGP would like to express its appreciation to Congress for a new program established and funded for the

first time this year: the Family Care Givers Program of the Older Americans Act.

This new program provides funding to the States so that they may assist family

care givers in obtaining the best, most appropriate care for their loved ones, as well

as offering care givers limited, but badly needed respite from their care-giving re-
461

sponsibilities. First year funding of $125,000,000 was authorized and appropriated

for fiscal year 2001. AAGP expects the need for these services to grow rapidly in

the future and urges the members of the Subcommittee to be responsive to this need

as it develops. In addition to caregiver programs and support services, research is

needed to fill in the gaps in our understanding of the psychiatric responses of caregivers to the chronic stresses of taking care of older adults with mental illnesses.

In addition to supporting research activities at the NIMH, AAGP supports increased funding for the other institutes at the NIH that have some jurisdiction over

geriatric mental health, including the NIA and the National Institute of Neurological Disorders and Stroke.

It is also critical that there be adequate funding increases for the mental health

initiatives under the jurisdiction of the CMHS within the Substance Abuse and

Mental Health Services Administration (SAMHSA). While research is of critical importance to a better future, the patients of today must also receive appropriate

treatment for their mental health problems. SAMHSA provides funding to State and

local mental health departments, which in turn provide community-based mental

health services to Americans of all ages, without regard to the ability to pay. The

Labor-HHS conference agreement for fiscal year 2001 increased funding for

SAMHSA by about 11.5 percent (from $2,651,342,000 to $2,958,001). AAGP urges

the Subcommittee to increase the funds available to SAMHSA for these purposes

to keep pace with this demand.

Furthermore, a top priority should be funding for the dissemination and implementation of evidence-based practices in ‘‘real world’’ usual care settings. Despite

significant advances in research on the causes and treatment of mental disorders

in older persons, there is a major gap between these research advances and clinical

practice in usual care settings. The greatest challenge for the future of mental

health care for older Americans is to bridge this gap between established research

findings and clinical practice in the community. A specific geriatric mental health

services initiative is needed to disseminate and implement evidence-based practices

in routine clinical settings across the states.

CONCLUSION

Based on AAGP’s assessment of the current need and future challenges of late life

mental disorders, we submit the following recommendations:

—The current rate of funding for aging grants at NIMH and CMHS is inadequate.

Funding for NIMH and CMHS aging research grants should be increased to be

commensurate with current need (approximately three times the current funding level). In addition, the anticipated projected future increase in mental disorders among our aging population in terms of dollar amount of grants and absolute number of new grants should be built into the budget process;

—A fair grant review process will be enhanced by committees with specific expertise and dedication to mental health and aging; and

—Infrastructure within NIMH and CMHS is needed that supports the development of initiatives in aging research, monitors the quality and number of applicants for aging research grants, and management of those grants. Specifically,

AAGP believes that individuals should be designated in the Office of the Director of NIMH and in the Office of the Director of CMHS to oversee the aging

research agendas and initiatives for these two agencies.

AAGP strongly believes that the present research infrastructure, health care financing, and healthcare personnel with appropriate geriatric training, and the mental health delivery systems are grossly inadequate to meet the challenges posed by

the expected increase in the number of elderly with mental disorders. The economic

impact of the aging baby boom generation on the Medicare and Social Security systems has already become a focus of national dialogue, but that there is another challenge that has not received attention. Because of reduced mortality in older adults

with chronic medical disorders, we can expect an unprecedented explosion in the

number of people over age 65 with potentially disabling chronic mental illnesses.

Congress must continue to support funding for research that addresses the identification, diagnosis, and treatment of mental illnesses, as well as support programs

that increase the quality of life for those with late life mental illness.

The American Association for Geriatric Psychiatry looks forward to working with

the members of this Subcommittee and others in Congress to establish aging research as a priority at NIMH and at CMHS.
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PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF IMMUNOLOGISTS

The American Association of Immunologists (AAI) is a professional association of

six thousand research scientists and physicians dedicated to understanding the immune system, resulting in the prevention, treatment, and cure of disease. We appreciate this opportunity to submit written testimony for the Hearing Record regarding

the fiscal year 2002 appropriations bill for the Departments of Labor, Health and

Human Services, and Education. Our comments will be confined to issues involving

the Department of Health and Human Services, and specifically, the National Institutes of Health (NIH).

FISCAL YEAR 2002 APPROPRIATIONS FOR THE NATIONAL INSTITUTES OF HEALTH

AAI is grateful for this subcommittee’s and the Congress’s strong commitment to

biomedical research through the ongoing effort to double the budget of the National

Institutes of Health. In addition to the sheer purchasing power of the increased appropriations—allowing for the funding of more quality research grants, better lab

equipment, and training for the next generation of scientists—this national commitment has energized researchers around the world who realize that many of the scientific achievements and discoveries of recent years—including the sequencing of

the human genome—are just the first essential steps toward unraveling the mysteries of the human body and the treatments that may prevent or even cure deadly

diseases. We urge this subcommittee, therefore, to support rapidly unfolding biological discoveries by continuing the process of doubling the NIH budget with additional

appropriations of $3.4 billion for fiscal year 2002, for a total budget of $23.7 billion.

IMMUNOLOGY AND ITS PROMISING RESEARCH

While ‘‘immunology’’ may not be a discipline that Americans contemplate in their

daily lives, AAI’s members’ life’s work affects every person throughout the world

every day. Immunologists study both the immune system that helps protect the

body from harm and the maladies—from the common cold or flu to cancer and

AIDS—which can invade it. Many of us work to discover the cause of a particular

immune response—which can range from successfully destroying an invading virus

or bacteria to fighting one’s own body tissues (resulting in an ‘‘autoimmune’’ response and possibly causing an autoimmune disease). Others work to find a way to

prevent an undesirable immune response, i.e., an allergic response to a vaccine or

drug treatment. And others of us work to find a treatment for a known immune response that leads to illness or disease (such as diabetes). So when you read the

newspaper and see stories about scientists working to develop effective vaccines for

HIV/AIDS and influenza; to discover new defenses against re-emerging infections

such as tuberculosis and drug-resistant bacterial infections; to regulate autoimmune

diseases such as diabetes and lupus; to develop treatments to prevent the rejection

of transplanted organs and bone marrow; and to discover the causes of cancer and

promising new treatments, you are reading about immunology and the budget of the

National Institutes of Health.

To give you an example of the type of research conducted by immunologists, let

us cite a few examples of some exciting work now being done.

—On March 9, 2001, the Washington Post reported on a new study by immunologists that supports the prospect of an AIDS vaccine. According to the article,

‘‘[i]n a study offering new evidence that AIDS can be controlled by vaccine, inoculated monkeys stayed healthy despite exposure to high levels of virus....

The new vaccine is being fast-tracked toward human testing.’’ The study was

reported in the March 9 issue of the journal Science.

—Immunologists are studying responses of the fortunate few people who are repeatedly exposed to HIV but don’t get the virus, to determine how their immune

system appears to fend off active infection of HIV-crucial information for the design of an effective vaccine.

—Immunologists are also working at understanding how the immune system can

recognize cells infected with viruses. Here mice, genetically modified to have

only a very simple immune system—but one which can recognize a lethal virus

infection—are critical to understanding how an immune response is initiated,

how the immune system remembers past infection, and therefore how it will respond to future infection. These studies, originally made for a virus infection in

mice, have led to clinical trials in cancer immunotherapy (see Time Magazine,

January 15, 2001).

—Immunologists are studying the role of cytokines (hormone-like substances

made by cells that regulate immune and other biological functions) in mice to

discover their role in protecting their hosts from intestinal parasites such as
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worms and also to determine their deleterious role in asthma, allergy, rheumatoid arthritis, and lupus. This research might help determine the best way

to reduce or prevent the overproduction of cytokines, to prevent these diseases,

and to identify and reduce side effects from potential treatments. Earlier research by this same team of scientists helped to determine that cytokines play

a critical role in causing asthma.

—Immunologists are studying how cytokines affect the immune response to selfantigens (molecules already in the body) in the insulin secreting cells in the

pancreas. Understanding the immune response is critical because we know that

autoimmune destruction of the pancreas is the cause of Type I diabetes, a disease which classically attacks young people. A recent paper has shown that by

changing the way the self-antigen is exposed to the immune system, the disease

can be prevented in mice genetically predisposed to develop diabetes.

—Immunologists are studying periodontal disease (gum disease), which is the

major cause of tooth loss in the United States. Current work is seeking to understand how the two major bacterial species cause this disease. This involves

cloning the bacterial genes necessary for allowing the bacteria to cause disease,

and understanding the body’s response to the bacteria. Both the bacteria and

the response are necessary to cause tooth loss.

—Immunologists are studying the effect of aging and environmental factors on the

development of autoimmune disorders, with a special focus on myasthenia

gravis—a disease that causes muscle weakness. In this disease, the immune

system responds to a critical molecule necessary for nerve signal conduction. Because this molecule is present only in very low amounts, people (and animals)

are able to develop an immune response since immune tolerance was never produced. Immunologists have created a transgenic mouse in which this tolerance

does occur. This allows the identification of the major mechanisms of disease

to be discovered and ultimately controlled.

—Immunologists have identified a novel DNA binding protein that is produced

only in the thymus and appears to play a role the production of the antigen receptor gene rearrangement. Because aberrant rearrangement of certain genes

(oncogenes) has been seen in many lymphomas and leukemias, immunologists

are studying the regulatory processes involved. Such studies may offer critical

insight into both diseases.

—Immunologists are studying systemic lupus erythematosus (lupus), an autoimmune rheumatic disorder which can cause arthritis, rashes, kidney failure,

central nervous system disease, and other serious medical problems. In studying

the antibodies that are made in the disease and the substances to which they

bind, a team of immunologists has theorized that the Epstein Barr virus may

play a role in causing this disease and is now testing this theory. These immunologists are also working to identify the genes which they believe may predispose people to develop lupus.

As the above examples show, the work of immunologists is varied and relevant

to the everyday lives of many American families. Our members devote their professional lives to painstaking work that may one day cure a disease or contribute on

some smaller but significant level to better scientific understanding of complex

human physiological reaction.

MAKING SCARCE DOLLARS GO FURTHER

As this subcommittee struggles with difficult decisions regarding the funding level

for NIH and other important government agencies and programs for fiscal year

2002, we would like to suggest two ways that we believe that dollars allocated to

biomedical research could be stretched further. First, our researchers have found an

increasing regulatory burden placed on them by various rules and regulations promulgated by a variety of government agencies. While our scientists appreciate that

their work is funded by taxpayer dollars and respect their duty to account for the

use of those funds, they have often found these regulations burdensome and lacking

any measurable benefit, taking valuable time (and money) away from the research

at hand.

Reducing paperwork and streamlining and simplifying rules would certainly help

obtain the greatest value from every research dollar.

Second, as our work described above makes clear, immunologists depend heavily

on the use of animal models in their research. Without the use of animals, theories

about immune system function and treatments that might cure or prevent disease

would have to be tested first on human subjects, something our society—and our

scientists—would never countenance. Despite the clear necessity for animal research, people and organizations that oppose such research are threatening sci-
464

entists who use animal models. The legal and extra-legal methods used by these

groups to further an animal-rights/anti-medical research agenda is diverting precious resources from our work, threatening the personal safety and security of scientists, and delaying the progress of important research that is already underway.

Addressing this ongoing problem is an additional cost that—were it relieved—would

enable NIH dollars to go further.

NIH BUDGET PLANS FOR SUPPORTING YOUNG SCIENTISTS

AAI would like to call to the subcommittee’s attention NIH’s announced plans to

increase the level of stipends for post-doctoral recipients. AAI has been deeply concerned about the future supply of biomedical researchers, and in particular, the

plight of post-doctoral fellows who are significantly underpaid and under-compensated for their work. In early March, the National Academy of Sciences (NAS)

held a Convocation on Enhancing the Postdoctoral Experience For Scientists and

Engineers to discuss post-doctoral issues and a report recently issued by its Committee on Science, Engineering, and Public Policy (COSEPUP). Among the many

recommendations of the COSEPUP committee was the need for better compensation

and employment benefits for post-doctoral fellows. NIH responded by releasing on

March 22 a statement in response to the NAS report (Notice NOT–OD–01–027), in

which it indicates its plans to increase the stipends for National Research Service

Award (NRSA) recipients over a period of five years. While AAI believes that the

urgency of the situation requires a phase-in of higher stipends and the offering of

basic employment benefits in considerably less than five years, AAI applauds NIH

for responding to the COSEPUP report promptly and greatly appreciates NIH’s

leadership in beginning to address the need for better compensation for post-doctoral fellows. We urge this subcommittee and the Congress to support efforts to address the immediate need for better compensation and benefits for our nation’s future biomedical research leaders.

NIH BUDGET ON RESEARCH MANAGEMENT AND SUPPORT (RMS) FUNDING

Current funding for management and oversight at NIH is $693 million, or 3.3 percent of the NIH budget. As funding for NIH has increased, allowing for large new

numbers of increasingly complex grants, there has been an inadequate increase in

support for oversight to ensure that the funds are used wisely and well. As Congress

has increasingly asked questions—rightfully so—about what NIH and the nation’s

researchers are doing with these additional funds, NIH is hampered by insufficient

staff to either answer those questions or to ensure fully the proper management and

oversight of existing grants.

Between 1984 and 2000, there was little if any increase in RMS funding. In fiscal

year 2000 and fiscal year 2001, there were increases of 8 percent and 10 percent

respectively, raising the RMS to its current level. But if NIH is to properly manage

taxpayer dollars, ensure the continuation of its excellent and highly regarded peer

review process, provide professional development to staff, manage its facilities, provide public education, and undertake the multitude of activities supported by the

RMS budget, AAI believes that an increase in the RMS budget to 4.5 percent of the

NIH budget—a level that is the historical average—is required. We urge this subcommittee to review this important budget category again this year, recognizing

that for NIH to use well—and account for—the generous funding increases you have

provided, the RMS budget needs your active support.

On behalf of AAI, may I express our appreciation for having this opportunity to

submit our remarks and invite any members of the subcommittee who have questions to feel free to contact me for further information.

PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF COLLEGES OF NURSING

The American Association of Colleges of Nursing (AACN) respectfully submits this

testimony to the Subcommittee with our requested funding priorities for nursing research and education programs. This federal support will be a critical piece in the

nation’s effort to overcome the nursing shortage. AACN represents over 550 baccalaureate and graduate nursing education programs in senior colleges and universities across the United States.

The country is in the midst of an emerging nursing shortage unlike any that the

nation has experienced over the past 30 years. Since 1994, AACN has noted declining enrollments in baccalaureate nursing programs. Increasingly, employers are reporting dramatic and crisis level shortages of nurses in their health care settings.

Hospitals are forced to close entire patient care units; ambulances are being di-
465

verted to other overcrowded facilities; and surgeries are being canceled due to the

lack of appropriately educated and skilled registered nurses (RNs). Nurse vacancy

rates are noted in all practice settings including long-term care, home care, and

public health. In addition, an aging workforce, with the average age of RNs up to

45.2 years, compounds the shortage.

Although employers are seeking a more highly educated nursing workforce for today’s complex health care environment, only 41 percent of nurses have a baccalaureate or higher degree. The growing shortage and the decline in enrollments are

accompanied by a number of other factors that will affect the ability of the nursing

profession to meet the demand for professional nursing care. The longitudinal American Freshman Study indicates that an extremely small percentage of freshman college students are choosing a nursing career. A recent national assessment of children’s career aspirations by the J. W. Thompson Company has found that young

children, particularly those who plan to seek a college education, also do not see

nursing as an attractive career option.

A lack of nursing faculty has had an impact on the shortage. The majority of

AACN member nursing programs report great difficulty filling budgeted faculty positions. The small one percent of doctorally prepared nurses in this country and the

lengthy completion time of a doctoral degree have limited the availability of nurses

prepared to function in a faculty role. Doctoral nursing students also are more often

part-time students and have maintained their full-time clinical or other positions.

Expansion of doctoral enrollments as full-time students would facilitate greatly the

production of available faculty. AACN members also report difficulty recruiting master’s prepared nursing personnel for faculty roles because of the great disparity between clinical salaries and the salaries available as a faculty member. Schools

would benefit from support initiatives that provide resources to augment salaries for

specialized faculty needed to support the entire program.

AACN recognizes that strategies to meet the growing nursing shortage must encompass private and public sector initiatives. Local communities and health care

employers are utilizing creative programs to recruit middle school students into the

nursing profession. States are introducing legislation funding scholarships and studies to assess statewide workforce need. We are asking the Subcommittee to graciously consider these requests and the effect that an unresolved RN shortage of

this magnitude will have on the future of health care in America.

NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)

We thank you and respectfully request a fiscal year 2002 funding level of $144.37

million, which reflects an increase of $40 million for the National Institute of Nursing Research. At this funding level, NINR will support significant new research on

health disparities in diseases such as diabetes and cardiovascular disease, self management of chronic pain, end-of-life research to address weight loss, muscle wasting,

fatigue, and caregiver issues. Most critical to enhancing research within the nursing

profession is infrastructure development that increases the pool of nurse investigators, expands programs to develop partnerships between research-intensive environments and smaller colleges and universities, and promotes career development for

minority researchers.

In an effort to develop the pool of nurse faculty and researchers, NINR directs

8 percent of its budget to research training. Research training dollars supported approximately 190 pre-doctoral nurse researchers and 70 post-doctoral researchers this

year. These numbers must be increased in the future to address recent recommendations of the National Research Council. Additionally, AACN’s 2000 Survey

of Institutional Data Systems claims 3,338 nurses in doctoral programs, indicating

that NINR supports less than 6 percent of those nurses in doctoral study. In view

of the national nurse faculty shortage of 500 unfilled positions in teaching and research, we recommend this significant increase in appropriations for additional stipends and training for pre- and post-doctoral researchers.

NINR provides research findings for the nation’s largest profession of health care

providers: 2.7 million RNs. In light of the increasing shortage of qualified professional nurses, the NINR requires a significant funding increase for the following

reasons:

—To provide clinically-based research findings that make a difference in the lives

of all Americans, from our youth whose health needs must be addressed to our

nation’s aging population of which many experience chronic, debilitating diseases.

—To establish the role of nurse researcher, which attracts bright young women

and men into a field that provides opportunities to both conduct meaningful re-
466

search and use important research findings that make a difference in people’s

lives.

NINR’s fiscal year 2001 funding is at $104.37 million. This is $14.83 million or

16.6 percent more than the fiscal year 2000 level. Nurses from across the nation

are thankful for this increase. It has provided resources for 81 new multi-year research grants beginning in fiscal year 2000 and an estimated 60 new studies, which

begin in fiscal year 2001.

The increase in appropriation for fiscal year 2000 enabled NINR’s success rate to

reach the NIH mean success rate of 32 percent for competing research projects for

the first time in its 15-year history. This is a significant improvement over fiscal

year 1999 when the success rate was only 14.4 percent. Because of NINR’s ability

to attract important applications for research studies, the success rate for fiscal year

2001, despite a good increase in appropriation, is estimated to be only 20 percent.

The fiscal year 2000 research findings from NINR-funded studies include 17 reports related to aging, long-term care, or Alzheimer’s and care giving. More studies

are reported in dozens of scientific articles in: HIV/AIDS patient care, cardiovascular disease prevention and care, child and adolescent health, critical care, diabetes, mental health, and the utilization of nurses in the health care system. In addition, NINR-funded investigators across the country produced scientific advances in

maternal-infant care, pain and other symptom management, and women’s health.

These findings together form the research base to establish evidence-based practice

for registered nurses providing direct patient care 24-hours a day, seven days a

week, all across the country.

In addition, NINR is the lead institute at NIH to coordinate research on end-oflife care, addressing the public’s disappointment with the current status of care at

the end of life. Other groups such as the Institute of Medicine, the Robert Wood

Johnson Foundation, and the Hartford Foundation recognizing this need especially

in light of our aging population. End-of-life care utilizes many of the skills of nurses

such as pain and other symptom management, clinical management to promote

quality of life, and family teaching and counseling. This focus helps families to identify and use resources to better cope with the stresses at this critical time.

The Subcommittee investment in NINR is well justified as nursing research contributes extensively to wellness and health choices that prevent disease. The NINR

supports investigators who conduct a broad range of clinical research, developing

and testing interventions to improve patient care, treat disease, manage chronic

conditions and address the physical and emotional concerns that are important to

the diverse American public. There is growing evidence of advances made possible

by NINR research, but I will highlight just four recent success stories. AACN believes that based on these and numerous other examples, it is clear that nursing

research is making a difference in health outcomes. For example, NINR research

has made a difference by identifying interventions or other studies to:

—Enhance the independence and reduce signs of distress among severely cognitively impaired nursing home residents.

—Develop new methodologies for investigating ways to reduce breast cancer risk

in women who have a genetic predisposition.

—Reduce the extremely high stress levels experienced by family members who

were involved with decisions to stop life-sustaining support for a terminally ill

loved.

—Reduce the risk of cardiovascular disease in children from minority backgrounds

who are living in rural areas.

THE NURSE EDUCATION ACT (NEA)

We also ask for increased funding of $25 million for the Nurse Education Act and

additional funding for the nursing student loan programs. AACN recommends an

increase in the NEA for fiscal year 2002 to $103.1 million for the NEA and $an additional $20 million directed to student loan programs. NEA appropriations for fiscal

year 2001 were $78.1 million. Central to increasing the availability of a well-trained

nursing workforce is the availability of educational grants and scholarships. Current

demand for nursing student loan support exceeds significantly the resources available. In addition, scholarship support is a major incentive to enter the profession

and facilitates full-time study.

Title VIII of the Public Health Service Act (PHSA), the NEA, is the major federal

statute providing authority for the Department of Health and Human Services to

fund initiatives to expand or improve nursing education. Authorities under Title

VIII provide for support of advanced practice nursing education, special initiatives

for nursing clinics, support of innovations in the delivery of nursing care, expansion

of enrollments in baccalaureate nursing programs, and development of initiatives to
467

expand minority nursing enrollments. Several of the programs assist schools with

their efforts to bring more students into baccalaureate nursing programs. In addition, the program for loans to nursing students allows students to acquire low interest rate loans that can be repaid through service in high need areas.

—Advanced Education Nursing Grants (Sec. 811).—The initiative provides grants

to schools to train advanced practice primary care nurse practitioners and nurse

midwives. It also provides grants to educate master’s and doctoral students as

clinical nurse specialists, public health nurses, nurse administrators, faculty,

nurse anesthetists, and non-primary care nurse practitioners. It includes

traineeships for master’s and doctoral students with a limit of 10 percent of appropriations for doctoral traineeships.

—Nursing Workforce Diversity Grants (Sec. 821).—To increase opportunities for

nursing education for disadvantaged students, including underrepresented minorities, this initiative furnishes scholarships, stipends, pre-entry preparation,

and retention activities. Grantees are responsible for accomplishing the objectives of their grants.

—Basic Nurse Education and Practice Grants (Sec. 831).—This initiative disseminates grants to schools of nursing to strengthen basic nurse education and practice with seven priority areas. The areas are: expanding nursing practice in noninstitutional settings to increase access to primary health care, training for care

of underserved and high risk populations, education for managed care, developing cultural competency, expanding baccalaureate enrollments, increasing

nursing career mobility, and nursing education in informatics and use of distance learning.

—Nursing Student Loan Program (NSLP) (Sec. 836).—AACN recommends an appropriation of at least $10.3 million for the NSLP for fiscal year 2002. Administered by the Division of Student Assistance, this program was created to address nursing workforce shortages. Academic institutions select students enrolled in nursing programs for participation in the program based on financial

need. The program operates on revolving funds received through student loan

paybacks and returned funding received from nursing schools that closedown.

In fiscal year 2001, only 291 out of 1,500 eligible collegiate schools of nursing

participate in the program because of reluctance to compete for the limited

funding. This loan program has received no new funding since 1983.

—Nursing Education Loan Repayment Program (NELRP) (Sec. 846).—AACN requests at least an additional $10 million for this program in fiscal year 2002.

The NELRP, administered by the Bureau of Primary Health Care, provides

loans to registered nurses, nurse anesthetists, and nurse practitioners in exchange for practicing in designated Health Profession Shortage Areas. Due to

funding limitations in fiscal year 2000, the Bureau provided loans of 60 percent

of the amount authorized to only 50 percent of the nurses applying for program

participation. The NELRP has $2 million in fiscal year 2001 funding.

SCHOLARSHIPS FOR DISADVANTAGED STUDENTS (SDS)

AACN recommends that SDS be funded at $55.63 million for fiscal year 2002, a

25 percent increase. Fiscal year 2001 funding is at $44.5 million. Scholarships for

Disadvantaged Students is a PHSA Title VII Program (Sec .737) that provides funds

to disadvantaged and minority health professions students. The statute directs 16

percent of the funds appropriated to nursing students. This program is the major

federal scholarship source for undergraduate nursing students and eliminates or reduces the financial barriers that may prevent these students from enrolling. The

majority of SDS recipients are minority students.

NATIONAL HEALTH SERVICE CORPS (NHSC)

AACN recommends maintaining the 10 percent set aside and increasing funds for

the NHSC to $300 million. The National Health Service Corps Scholarship and Loan

Repayment programs (PHSA Title III) seek to attract health professionals to practice in Health Professional Shortage Areas that lack such providers. Many of those

areas are rural, and have difficulty attracting and retaining caregivers. Nursing has

a 10 percent set aside that provides funding for certified nurse midwives, nurse

practitioners, and psychiatric clinical nurses specialists.

CONCLUSION

In summary, AACN respectfully recommends the following appropriations for fiscal year 2002:
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[In millions of dollars]

Amount

National Institute of Nursing Research ............................................................... 144.37

Nurse Education Act .............................................................................................. 103.1

Nursing Student Loan Program ........................................................................... 10.3

Nursing Education Loan Repayment Program ................................................... 12

Scholarships for Disadvantaged Students ........................................................... 55.63

National Health Service Corps Scholarship/Loan ............................................... 300

PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF COLLEGES OF

OSTEOPATHIC MEDICINE

As President of the Philadelphia College of Osteopathic Medicine and Chairman

of the Board of Governors of the American Association of Colleges of Osteopathic

Medicine (AACOM), I am pleased to present the views of our nineteen colleges on

fiscal year 2002 appropriations for health professions education assistance programs

under Titles VII and VIII of the Public Health Service Act. First, I would like to

express the American Association of Colleges of Osteopathic Medicine’s appreciation

for the past efforts of this Subcommittee to maintain a commitment to health professions education. The Subcommittee’s vision has enabled health professions schools

in general and colleges of osteopathic medicine in particular to address the physician workforce needs dictated by a rapidly changing health care delivery system.

However, we are not yet able to say we are in a position to completely meet these

workforce needs. ‘‘Healthy People 2010,’’ a document that serves as a blueprint for

health care delivery, has articulated two overarching goals: Increase Quality and

Years of Healthy Life; and Eliminate Health Disparities. To achieve these goals by

2010, we must begin now to train health professionals who have the necessary skills

and commitment. More than ever, institutions need the support of Titles VII and

VIII programs to develop the kind of workforce consistent with ‘‘Healthy People

2010.’’

At the same time we recognize the responsibility of the Subcommittee to examine

all programs in light of their cost effectiveness in meeting the health care needs of

all Americans. We believe colleges of osteopathic medicine measure particularly well

under such scrutiny. By training and by tradition, osteopathic physicians practice

‘‘hands on,’’ holistic medicine and value the highly close and interactive physicianpatient relationship that is characteristic of our profession. This philosophy has

driven a unique educational model in our medical schools. The American Association

of Colleges of Osteopathic Medicine is especially proud that the model of osteopathic

medical education is entirely consistent with the Federal objectives of addressing

physician geographic maldistribution in the United States and increasing access to

primary care services. Mr. Chairman and Members of the Subcommittee, it is important to note that this model has not been developed recently in response to Federal funding requirements. Rather, it has been at the core of our osteopathic medical

education for over 100 years.

The principal vehicle for addressing the specialty and geographic maldistribution

of physicians has been through primary care education and training. The American

Association of Colleges of Osteopathic Medicine member schools have a long history

of dedication to training primary care physicians to work in America’s smaller communities, rural areas and underserved urban areas. Osteopathic physicians represent 5.5 percent of the U.S. physician workforce, but constitute 15 percent of the

physicians practicing in communities of fewer than 2,500 population.

The mission statement of my own institution reflects this commitment: ‘‘ Philadelphia College of Osteopathic Medicine is dedicated to providing programs of study to

educate skilled professionals in health and science fields and competent and caring

osteopathic physicians. The programs of study are built on the foundations of primary care, an orientation to the needs of the community and are guided by osteopathic tradition, concept and practice. The college is committed to the advancement

of knowledge and encouragement of intellectual growth through research and leadership and to the advancement of the community through health promotion, education and service.’’

Mr. Chairman and Members of the Subcommittee, all of our osteopathic medical

schools share similar missions. These missions are reflected in the profile of our

medical students. Our latest data show that over 40 percent of our entering students come from small towns and rural areas (i.e. towns of fewer than 50,000).

The health professions assistance programs under Titles VII and VIII of the Public Health Service Act have been valuable in our efforts to continue to ensure this
469

commitment. In Public Law 105–392, the Health Professions Education Partnership

Act of 1998, 44 different Federal health professions training programs were consolidated into seven clusters. These clusters provide support for training of underrepresented minority and disadvantaged students; training of primary care and dental

providers; the establishment and operation of interdisciplinary community-based

training activities; health professions workforce and analysis; public health workforce development; nursing education; and student financial assistance. These programs are designed to meet the health care delivery needs of the over 2,800 Health

Professions Shortage Areas in the country. Many rural and disadvantaged populations depend on the health professionals trained by these programs as their only

source of health care. For example, without the practicing family physicians who are

currently in place, an additional 1,332 of the United States’ 3,082 urban and rural

counties would qualify for designation as primary care Health Professions Shortage

Areas.

Titles VII and VIII programs have had a significant impact in reducing the nation’s Health Professions Shortage Areas. Indeed, a recent study estimated that if

funding for Title VII programs were doubled the effect would be to eliminate the

nation’s Health Professions Shortage Areas in as little as 6 years (Politzer, RM,

Hardwick KS, Cultice JM, Bazell, C. Eliminating Primary Care Health Professions

Shortage Areas: The Impact of Title VII Generalist Physician Education, The Journal of Rural Health, 1999: 15(1): 11–19).

A study by the Robert Graham Center showed that the receipt of Title VII family

medicine grants by medical schools produced more family physicians and more primary care doctors serving in rural areas and health professionals shortage areas.

Over 69 percent of Title VII funded internal medical graduates practice primary

care after graduation. This rate is nearly twice that of programs not receiving Title

VII funding.

Among the programs within these clusters that have been especially important to

enhancing osteopathic medical schools’ ability to train the highest quality physicians

are: General Internal Medicine residencies; General Pediatric Residencies; Family

Medicine Training; Preventive Medicine Residencies; Area Health Education Centers; Health Education and Training Centers; Health Careers Opportunities Programs; Centers of Excellence Programs; and Geriatric Training Authority.

Let me give you examples of how Title VII programs have benefited not only the

osteopathic medical schools receiving the support, but also the citizens in the communities and states they serve.

The Philadelphia College of Osteopathic Medicine (PCOM) received a 3 year

grant, now in its final year, from the Health Resources and Services Administration

to develop a predoctoral curriculum which places significant emphasis on a comprehensive and integrative approach to providing health care to medically underserved persons. The three major curriculum goals are:

—To develop, implement and evaluate a teaching module which focuses on preventive medicine for the medically underserved in a managed care environment.

—To develop, implement and evaluate a teaching module which focuses on understanding the roles of family and community in health care delivery.

—To develop, implement and evaluate a teaching module which focuses on the application of evidence-based medicine in patient care and on becoming a self-directed learner.

This program will serve as a model for medical institutions that, like the Philadelphia College of Osteopathic Medicine, are interested in reaching out to medically underserved populations by training doctors to understand the socioeconomic aspects

of patients’ lives in order to provide them with the most appropriate, comprehensive,

and integrative health care.

Nova Southeastern University College of Osteopathic Medicine has a Model Area

Health Education Center (AHEC) Program Grant that serves underserved rural and

inner-city communities throughout South and Central Florida. Nearly 500,000 people reside in the many Health Professions Shortage Areas in this nineteen county

region served by this AHEC program. Among the many special initiatives have been

an active AHEC Rural Medicine Program, an AHEC Health Careers Camp, a Library Without Walls Program, A Practice Opportunities Program, and Distance

Learning Teleconferences. This AHEC Program has also worked closely with three

other medical schools in Florida to develop a Statewide Florida AHEC Network to

cultivate and leverage additional state support to maximize overall program scope

and effectiveness. In 1997, this Florida AHEC Network was recognized by its peers

across the nation for its program excellence in developing an innovative and collaborative statewide network of community/academic partnerships, and for significantly

improving the supply and distribution of primary care health professionals in underserved communities of Florida.
470

The Chicago College of Osteopathic Medicine of Midwestern University is in their

third year of funding with an Establishment of Family Medicine grant. This grant

has allowed for the establishment of a new course ‘‘Topics in Family Medicine’’ for

MSII students. The Chicago College of Osteopathic Medicine took material that was

historically taught the last eight week of the MSII year and developed it into a full

year course focusing on topics in medicine normally seen by primary care physicians

and including issues in managed care and practice management. A simulated patient program has been incorporated that allows students to practice dealing with

difficult patient situations such as death and dying. Community medicine sites have

been enhanced and approximately 50 new preceptors have been added. This spring,

the Chicago College of Osteopathic Medicine will sponsor a faculty development program for all new preceptors. There have also been great strides in the area of technology and on-line capabilities for things such as distance learning with the students.

Title VII also authorizes student assistance programs that are especially important to osteopathic medical students. Our students have the highest average debt

upon graduation among health professions. Congress should be concerned with

minimizing the debt load of graduates of health professions schools, if they, in turn,

can be expected to hold down medical costs, practice in primary care, and locate in

underserved areas.

Title VII grants have been a crucial factor in the establishment and growth of primary care departments and have enabled them to develop innovative curricula.

These grants represent the only Federal initiative that has specifically encouraged

students to consider careers in primary care, a clearly identified national priority.

With the exception of fiscal year 2001, appropriations for Titles VII and VIII programs have remained relatively flat for a number of years. Thus, the ability to meet

the workforce needs mentioned earlier becomes more difficult.

Accordingly, Mr. Chairman and Members of the Subcommittee, AACOM recommends that the fiscal year 2002 funding level for Titles VII and VIII be $440 million. These figures do not include funding for the children’s hospitals graduate medical education program, which is an amount separate from Titles VII and VIII funding. This funding level would provide a much needed boost toward ensuring the

training of a workforce who will be delivering the types of services and providing

the full access to these services identified in Healthy People 2010.

Finally, Mr. Chairman and Members of the Subcommittee, the American Association of Colleges of Osteopathic Medicine supports the Ad Hoc Group for Medical Research Funding request of $23.7 billion for the National Institutes of Health for fiscal year 2002. This $3.4 billion (16.5 percent) increase represents the fourth step

toward the bipartisan goal of doubling NIH funding over the 5-year period from fiscal year 1999 to fiscal year 2003. Although osteopathic medical schools in the past

have not engaged in research activities nearly to the extent of our allopathic brethren, we have been steadily increasing the research capabilities of our institutions.

Again, I appreciate the opportunity to present our views to the Subcommittee. If

I can provide you with any additional information, you may contact either me at

the Philadelphia College of Osteopathic Medicine or Michael Dyer, Vice President

for Government Relations at AACOM (301) 968–4152.

PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF COLLEGES OF PHARMACY

RECOMMENDATIONS FOR FISCAL YEAR 2002

[In thousands of dollars]

Public Health Service Act Title VII Programs

Fiscal year

2001 2002

recommendation

Health Careers Opportunity Program .............................................................................. 32,800 35,000

Scholarships for Disadvantaged Students ...................................................................... 44,500 48,000

Faculty Loan Repayment ................................................................................................. 1,300 2,300

Health Professions Workforce Information and Analysis ................................................ 826 1,200

Your past support of the Title VII of the Public Health Service Act programs

means improved access to care for all Americans. The health professions students

and schools supported by these programs are the mostly likely to offer their services

to underserved communities and practice in sites like community health centers.
471

With Title VII programs facing substantial reductions in the President’s fiscal year

2002 budget, your support for these programs is important again this year.

The leadership and faculty of our nation’s colleges and schools of pharmacy are

committed to educating professional pharmacists capable of and comfortable with

providing comprehensive pharmacy services to the diverse populations they serve.

A recent survey of the pharmacy services provided at community health centers,

conducted by the University of Texas at Austin under a grant from the Health Resources and Services Administration’s (HRSA) Bureau of Primary Care, found that

the culturally diverse patient populations served by the CHCs benefit from improved health promotion counseling by pharmacists with similar cultural background.

Individuals considering pharmacy as a career choice and their teachers (pharmaceutical education faculty, and colleges and schools) all benefit from the Title VII

programs such as:

—Health Career Opportunities Program (HCOP);

—scholarships for disadvantaged students (SLD);

—faculty loan repayment and faculty training fellowships (FLRP); and

—Centers of Excellence programs (COE).

Your support of critical Title VII programs is needed since the diversity of the current pharmacist workforce, or any other health professions workforce, does not mirror the diversity of our society in general.

The fact that we need to educate more pharmacists, in general, is supported by

a congressionally mandated study that the Department of Health and Human Services (HHS) released last December. The Pharmacist Workforce: A Study of the Supply and Demand for Pharmacists indicates that the demand for pharmacists will remain strong for the foreseeable future. Improving the opportunity for students from

culturally diverse backgrounds is more important than ever. In light of the study,

targeting funds to pharmacy students and colleges and schools of pharmacy could

prove beneficial. The health workforce data HRSA currently collects through the National Center for Health Workforce Information and Analysis (NCHWIA) within the

Bureau of Health Professions is insufficient to assist policy makers to determine

how many active pharmacists there are. With increased appropriations NCHWIA

could establish a health professions database, including pharmacists, that is

verifiable, reliable, indicative of health professions numbers at the state, county and

local level, and not merely a repository of statistics from professional associations

and societies. This database could also be used to improve the decision making process for placement of National Health Service Corps personnel.

Your consideration of our recommendations is greatly appreciated. Please do not

hesitate to contact our office should you require additional information.

PREPARED STATEMENT OF THE AMERICAN ASSOCIATION OF PHARMACEUTICAL

SCIENTISTS

SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS

AAPS supports the continual efforts to double the National Institutes of Health

(NIH) budget by providing a 16.5 percent increase for fiscal year 2002, to $23.7 billion.

Basic scientific research conducted at the National Institutes of Health or sponsored by NIH has resulted in a better understanding of new therapies for many diseases. The American Association of Pharmaceutical Scientists (AAPS) represents

scientists in academia, industry and government. While NIH funding does not support all of our members, the impact of scientific discoveries derived from NIH sponsored research has broad implications for all who are developing new treatments.

Pharmaceutical scientists trained in academic institutions under the auspices of

NIH often become noted academic, industrial or governmental researchers. Many of

these scientists create knowledge in the pharmaceutical sciences that forms the

basis for new approaches in the treatment of the diseases that bedevil mankind.

AAPS members develop new methods of drug discovery, drug delivery and related

technologies, pharmaceutical analysis, new information regarding drug metabolism

and disposition, clinical evaluation, pharmacoepidemiology, and pharmacoeconomics.

All areas are important in ensuring the safety, efficacy, and availability of new

therapeutic modalities.

Currently, pharmaceutical scientists advise the NIH in direct collaborations and

by participating in many study section review boards. Many pharmaceutical scientists have been involved with ‘‘start-up’’ biotechnology companies. A few of these

entities are enormously successful and have changed the way that some diseases are
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treated. Others are involved in innovative research that may lead to the next big

breakthrough in the treatment of a number of diseases. With the proposed reorganization of the NIH review process, this may be an appropriate time for our 11,000

members to expand their involvement in the evaluation of research related to the

pharmaceutical sciences and we stand ready to do so. Because of the importance of

the discoveries by NIH, AAPS urges Congressional support for funding at or above

the proposed levels. Continued NIH funding is necessary to continue the leadership

and reputation of the United States in the fields of biomedical research and pharmaceutical sciences. There has been an explosion of biomedical and pharmaceutical

knowledge in the last few years and it is crucial that this knowledge now be used

to develop new therapies for those in need.

PREPARED STATEMENT OF THE AMERICAN COLLEGE OF CARDIOLOGY

INTRODUCTION

The American College of Cardiology (ACC) is a 25,000-member, professional medical society and educational institution whose mission is to foster optimal cardiovascular care and disease prevention through professional education, promotion of

research, and leadership in the development of standards and guidelines and the

formulation of health policy. The ACC submits for the record this statement in support of fiscal year 2002 funding for the National Heart, Lung, and Blood Institute

(NHLBI).

Thanks to the research support of the NHLBI, patients have benefited from the

emergence of advanced technologies, devices, and pharmaceuticals. Medical research

has played a major role in a notable decline in the number of deaths from cardiovascular disease over the past three decades. Yet, cardiovascular disease continues

to claim more lives each year than the next seven leading causes of death combined.

This year, it is estimated that nearly one million Americans will die as a result of

heart and blood vessel/vascular disease. More than 60 million Americans are living

with one or more types of cardiovascular disease. Fortunately, many of these individuals are living better and more productive lives as a result of new drug and device therapies, surgical innovations, prevention initiatives, and educational programs—all made possible in part through NHLBI-sponsored research.

Because cardiovascular disease continues to affect the lives and productivity of

millions of Americans, and because researchers are on the brink of many new and

exciting medical discoveries, it is critical that the subcommittee maintain its longstanding support for the NHLBI, specifically heart-related research.

THE COST OF HEART DISEASE

In 1999, the total economic impact—direct and indirect costs—of heart disease was $183 billion, of which $81 billion is attributed to lost productivity—people unable to work or care for their families. According to the National Institutes of Health

(NIH), 450,000 Americans age 65 and older require home or hospice care due to cardiovascular disease, and congestive heart failure is the largest cause of hospitalization for aging Americans. Investments in cardiovascular research today will result

in future savings to the health care system and to society. According to a report

issued in May 2000 by the congressional Joint Economic Committee, it is estimated

that the average American has gained a value of $85,000 in increased longevity

from medical advances in heart disease since 1950, at a cost of $35,000 per person

in research spending—a gross investment return of about 240 percent of costs.

Last year, Congress demonstrated its commitment to medical research by providing a 15 percent increase in funding to the NIH. The ACC recognizes this commitment and hopes Congress will continue to work toward doubling the NIH’s budget by 2003.

GROUND-BREAKING HEART RESEARCH ADVANCEMENTS

In 1991, the NIH launched the Human Genome Project. Innovative research in

human genetics holds great promise for the prevention, diagnosis, and treatment of

cardiovascular disease. Today, the NHLBI is a leader among other NIH institutes

in gene research.

In September 2000, the NHLBI launched the Programs for Genomic Applications.

This $37 million initiative is designed to advance genomic research in the areas of

heart, lung, blood, and sleep disorders by deciphering individual genes and functions

and then applying those findings to what is already known about the mapping and

sequence of the human genome. The initiative will accelerate progress in heart,

lung, blood, and sleep research by stimulating investigator-initiated research and by
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making information immediately available to the research community, thereby allowing other scientists to develop separate relevant studies cost effectively. Ensuring investigators have the tools necessary to conduct genomic analysis expands the

potential for medical discovery.

NHLBI-funded researchers recently grew heart valves in laboratories using new

tissue-engineering techniques. More than 60,000 patients in the United States receive replacement heart valves each year. Although the valves’ performance has

been excellent, problems such as abnormal clotting or poor durability limit their effectiveness. Further research efforts are needed to improve these new tissue-engineering techniques so that heart valves of higher durability and quality can be produced. Scientists are hopeful that someday laboratory-grown implantable valves will

last an entire lifetime, actually growing and maturing with the patient.

With the help of NHLBI research funding, scientists are seeking ways for patients

to grow blood vessels in the heart to replace the ones they have lost as a result of

a heart attack. During a heart attack, blockage in coronary arteries leaves a portion

of the victim’s heart tissue without oxygen. When this happens, part of the heart

tissue begins to die. Research has indicated that it is possible to grow new blood

vessels in the heart; however, this research is still in its infancy, necessitating continued funding. This research may yield hope that heart attack victims will someday

be able to regenerate blood vessels and keep damaged tissue alive.

SUPPORT FOR CLINICAL TRIALS

All scientific developments in biomedicine must pass through clinical research before they can benefit patients. A critical component of clinical research is trials that

allow physicians to apply the results of research in practice. Clinical trials can also

be an important tool in identifying early on therapeutic strategies and pharmacological agents that have the potential to reduce health care costs.

To alter clinical practice, large-scale randomized trials are usually necessary to

demonstrate unequivocally the effectiveness of a new drug or device or a new application for an existing drug or device. Some of these trials require thousands of patients to be studied over several years. For example, funding is needed to conduct

large-scale clinical trials to study heart failure in the elderly. Large trials are also

needed to examine ways in which heart disease can be treated once it is detected.

While large-scale clinical trials require a significant financial commitment, they

hold the potential to improve patient well-being and to reduce health care spending

over time. The ACC believes that continued funding increases are needed to significantly increase clinical research overall, and large-scale clinical trials specifically,

while also increasing funding levels for basic research. Funding for basic science and

clinical trials must go hand-in-hand, and there cannot be increased funding for one

at the expense of decreased funding for the other.

The ACC asks the subcommittee to ensure that increased funding be made available for the training of clinical investigators. Clinical investigators, or physician-scientists, are quickly becoming a ‘‘dying breed.’’ Critical to the advancement of medical science, clinical investigators bridge scientific discoveries and their application

at the patient bedside. Today, young physicians are being forced to choose between

performing research or practicing medicine. The demands of managed care and

other health insurance programs have further precluded physicians from performing

basic research and supervising patient care at the same time. Incentives are needed

to attract physicians to the important field of clinical investigation. Increased resources must also be dedicated to train a new generation of clinical investigators

who are well trained in biostatistics, research protocol designs, bioethics, and outcomes analysis. So many of the advances in patient care in the last 30 years have

come from the research efforts of these investigators who bridge the basic and clinical domains. They are a vital link in our battle against premature death and disability from heart and vascular disease, and their training must be supported.

HEART RESEARCH INITIATIVES AND OPPORTUNITIES

Congestive Heart Failure Clinical Network

It is estimated that 4.8 million Americans suffer from congestive heart failure and

that approximately 400,000 new cases are diagnosed every year. Health care costs

associated with heart failure are estimated at $40 billion annually. More effective

treatments are needed to address this growing public health problem. The NHLBI

plans to establish a collaborative network of clinical research centers and a data coordinating center to conduct clinical studies in heart failure. Clinical networks have

been shown to be an effective method for translating promising basic research findings into clinical research and practice. This initiative will allow for investigations
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focused on women and minorities and on programs to train physicians in clinical

research.

Bone Formation and Calcification in Cardiovascular Disease

Evidence suggests that a relationship exists between bones and blood vessels. Research, however, is needed to determine whether there is a link between bone formation, repair, and breakdown (e.g., osteoporosis) and the development of cardiovascular disease. Scientists already know that patients who take statin drugs to

lower cholesterol levels are at a decreased risk of bone fractures. Conversely, studies

have found that people with low bone mass may have an increased risk of developing or dying from cardiovascular disease. Further research in this area may lead

to strategies to prevent both cardiovascular disease and osteoporosis.

Lifestyle Intervention With Stress Management After Heart Attack

Mental stress has been shown to trigger myocardial ischemia. Patients with coronary artery disease who experienced myocardial ischemia following mental stress

tests had higher than expected rates of subsequent cardiac events. Results from rehabilitation and prevention programs that included stress management interventions have shown that behavioral interventions may improve quality of life and reduce morbidity and mortality of patients with coronary artery disease. However, because those trials used small sample sizes, it has been difficult to accurately assess

the effect of stress management interventions. The NHLBI has suggested the need

for a pilot study of behavioral interventions to determine the feasibility of recruiting

patients, delivering interventions, ascertaining the effects on adherence, and assessing the progression of coronary artery disease and other clinical outcomes.

Public Access to Defibrillation

About one fourth of the 300,000 annual deaths from sudden cardiac arrest occur

outside the home—in public areas. In August 2000, the NHLBI launched a nationwide pilot program to test public access to automated external defibrillators (AEDs).

AEDs are devices that automatically analyze heart rhythms and deliver an electric

current to the heart of a cardiac arrest victim. Survival rates after cardiac arrest

are low, averaging 4 percent. However, survival rates can be increased by shortening the time to defibrillation. The study will place AEDs in 24 communities across

the Unites States and Canada. Researchers already know that AEDs save lives. The

purpose of this study is to look at the life-saving potential and cost effectiveness of

AEDs when used by trained lay-individuals. When the study, which will be conducted over 30 months, is complete, 1,000 sites will be equipped with AEDs. As of

March, 850 of those sites had been approved for the placement of AEDs.

Recognizing the critical importance of early defibrillation, the ACC asks the subcommittee to support $12.5 million in funding for implementation of the Rural Access to Emergency Devices Act, Public Law 106–505, the Public Health Improvement Act. The funding will be used to help rural communities buy AEDs and to

train rural emergency responders in the use of AEDs.

PREVENTION, EDUCATION, AND PRACTICE

Efforts must be strengthened to prevent the incidence of heart attacks, coronary

heart disease, heart failure, and high blood pressure through increased patient and

physician education if we are to win the war against heart disease. We know that

heart disease is linked definitively to hypertension, high cholesterol, obesity, diabetes, smoking, and physical inactivity. The NHLBI’s public education programs—the

National High Blood Pressure Education Program, the National Cholesterol Education Program, the Obesity Education Initiative, and the National Heart Attack

Alert Program—make information readily available to patients, families, and health

professionals.

The earlier that heart disease is detected, the better it can be treated to prevent

its development. In September 2000, the NHLBI launched a 10-year, multi-center

study to find new ways of detecting heart disease early, before it produces symptoms. The $68 million Multi-Ethnic Study of Atherosclerosis involves six centers,

which will recruit 6,500 participants. The hope is that the study will yield more specific predictors of heart disease and will determine which factors best predict heart

disease in men and woman and in different ethnic groups.

One of the fastest growing public health problems in this country is adult and

childhood obesity. People who are overweight or obese are at greater risk for several

major diseases, including heart disease and stroke. More than 108 million adults in

the United States are overweight or obese. Even more startling, an estimated 5 million children in this country between age six and 17 are considered overweight.
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Just recently, the NHLBI unveiled a new tool for health care providers and the

public to combat obesity. A ‘‘practical guide’’ is now available to physicians and

other health care professionals. The guide includes a 10-step plan and a quick reference tool to help physicians assess, classify, and treat patients who are overweight

and obese. The guide also includes information for patients on diet, physical activity,

and tools for behavioral change.

The NHLBI has also funded research targeted at the prevention and treatment

of obesity. NHLBI-funded researchers have found that in overweight individuals,

high dietary sodium intake is strongly associated with an increased death rate, particularly from cardiovascular disease. The average adult in the United States consumes well above the recommended daily sodium level of 2,400 milligrams. Knowing

this, physicians and other health care providers can suggest reducing sodium intake

as a low-cost intervention for those who have difficulty losing weight as a way to

help lower their risk of death from cardiovascular disease.

Another NHLBI study has shed new light on genetic predisposition to obesity. Additional research is needed to gain a better understanding of the leptin receptor

gene, the gene linked to fat accumulation. Researchers have found that a variation

in the leptin receptor gene is associated with higher fat levels in middle-age white

males, but not in black males or in women of either race. This suggests that leptin

therapy may be effective only in middle-age white males, and that other genetic factors influence excess fat accumulation in women and blacks. Understanding the

leptin receptor gene will be an important step in developing effective preventive and

therapeutic strategies to fight obesity.

There is much to be done to ensure that preventive and therapeutic measures

proven effective in the fight against cardiovascular disease are adopted by physicians. Cardiovascular drugs, such as anti-hypertensives and beta-blockers, have

played a key role in the decline of heart disease-related deaths. Beta-blockers, drugs

that are used to slow the rate and force of the heart’s contractions and to stabilize

the heart’s rhythm, are still underused in treating heart attack patients in the

emergency room. Funding is needed to gather evidence-based information that can

be used to improve health care practices by physicians and other health care providers. The ACC supports increased funding to the Agency for Healthcare Research

and Quality for the purposes of improving health care quality.

CONCLUSION

Beyond better public awareness and the incorporation of research advances into

practice, reducing the number of cardiovascular-related deaths is greatly dependent

upon research sponsored by the NHLBI. We must intensify our cardiovascular disease research efforts now in an effort to prevent an increase in the prevalence of

cardiovascular disease that will otherwise accompany the aging of the so-called

‘‘baby-boomer’’ generation. The ACC hopes the subcommittee shares its optimism

about the unique opportunities scientists and clinical investigators now have to

achieve their long-standing goal of conquering this nation’s number-one killer. In

summary, the ACC encourages the subcommittee to provide a funding level of at

least $2.679 billion for the NHLBI in fiscal year 2002. Furthermore, the ACC asks

that at least $1.650 billion of that amount be devoted to heart- and stroke-related

research.

The ACC hopes the subcommittee will consider this request. It is a wise investment in the future health of our nation.

PREPARED STATEMENT OF THE AMERICAN DENTAL HYGIENISTS’ ASSOCIATION

On behalf of the American Dental Hygienists’ Association (ADHA), thank you for

the opportunity to present testimony regarding fiscal year 2002 appropriations for

the Department of Health and Human Services. I am Stan Peck, ADHA’s Executive

Director.

ADHA is the largest national organization representing the more than 100,000

dental hygienists across the country. Dental hygienists are preventive oral health

professionals who are licensed in each of the fifty States. As prevention specialists,

dental hygienists understand that recognizing the connection between oral health

and total health can prevent disease, treat problems while they are still manageable, and conserve critical health care dollars. Dental hygienists are committed to

improving the nation’s oral health, a fundamental part of total health. Please visit

the ADHA web site at <<www.adha.org>>.
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U.S. SURGEON GENERAL’S MAY 2000 REPORT ON ORAL HEALTH IN AMERICA

Last May, U.S. Surgeon General David Satcher issued ‘‘Oral Health in America:

A Report of the Surgeon General.’’ This landmark report confirms what dental hygienists have long known: that oral health is an integral part of total health and

that good oral health can be achieved. Key findings enumerated in the Report include:

—Oral diseases and disorders in and of themselves affect health and well-being

throughout life.

—Safe and effective measures exist to prevent the most common dental diseases—

dental caries (tooth decay) and periodontal diseases.

—Lifestyle behaviors that affect general health such as tobacco use, excessive alcohol use, and poor dietary choices affect oral and craniofacial health as well.

—There are profound and consequential oral health disparities within the U.S.

population.

—More information is needed to improve America’s oral health and eliminate

health disparities.

—The mouth reflects general health and well-being.

—Oral diseases and conditions are associated with other health problems.

—Scientific research is key to further reduction in the burden of diseases and disorders that affect the face, mouth and teeth.

The Surgeon General’s Report on Oral Health challenges all of us—in both the

public and private sectors—to address the compelling evidence that not all Americans have achieved the same level of oral health and well-being. The Report describes a ‘‘silent epidemic’’ of oral diseases, which affect our most vulnerable citizens—poor children, the elderly and many members of racial and ethnic minority

groups. The Surgeon General insists that additional steps be taken to address these

disparities in oral health status.

ADHA suggests that one such step is to improve access to the preventive oral

health care services provided by dental hygienists. This is important because unlike

most medical conditions, the three most common oral diseases—dental caries (tooth

decay), gingivitis (gum disease) and periodontitis (advanced gum and bone disease)—are proven to be preventable with the provision of regular oral health care.

Despite this prevention capability, tooth decay—which is an infectious transmissible

disease—still affects more than half of all children by second grade. Clearly, more

must be done to increase children’s access to oral health care services.

While the profession of dental hygiene was founded in 1923 as a school-based profession, today the provision of dental hygiene services is largely tied to the private

dental office. Increased utilization of dental hygienists in schools, nursing homes,

and other sites—with appropriate referral mechanisms in place to dentists—will improve access to needed preventive oral health services. This increased access to preventive oral health services will likely result in decreased oral health care costs per

capita and, more importantly, improvements in oral and total health.

ADHA is committed to working with the Congress to improve access to oral health

care services, particularly for children eligible for Medicaid and the State Children’s

Health Insurance Program (SCHIP).

NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

As the Surgeon General’s Report on Oral Health so clearly demonstrates, the nation’s oral health can and must be further improved. The National Institute of Dental and Craniofacial Research (NIDCR) is the nation’s focal point for oral health research and NIDCR’s work has yielded significant advancements in oral health.

Moreover, NIDCR’s work in dental research has not only resulted in better oral

health for the nation, it has also helped curb increases in oral health care costs.

Americans save nearly $4 billion annually in dental bills because of advances in

dental research and an increased emphasis on preventive oral health care. To enable NIDCR to continue and to build upon its important research mission, ADHA

joins with other groups in the oral health community to recommend $370 million

for NIDCR.

ORAL HEALTH INITIATIVE

ADHA is pleased to see the increasing recognition among federal Policymakers of

the importance of oral health to overall health and well-being. A primary illustration of this appreciation for the link between oral health and general health is the

Oral Health Initiative at the Health Resources and Services Administration (HRSA).

The goals of HRSA’s Oral Health Initiative are to work toward the elimination of

disparities in oral health status and to improve access to oral health services. Re-
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gretfully, much work needs to be done in both of these areas to help assure that

children enrolled in Medicaid and the State Children’s Health Insurance Program

(SCHIP) are provided access to necessary oral health services.

As the General Accounting Office (GAO) confirmed last year in two separate reports to Congress, ‘‘dental disease is a chronic problem among many low-income and

vulnerable populations’’ and ‘‘poor children have five times more untreated dental

caries (cavities) than children in higher-income families.’’ The GAO further found

that the major factor contributing to the low use of dental services among low-income persons who have coverage for dental services is ‘‘finding dentists to treat

them.’’ ADHA pledges to work with HRSA to achieve the goals of the Oral Health

Initiative. Increased utilization of dental hygiene services—appropriately linked to

the services of dentists—is critical to addressing the nation’s crisis in access to oral

health care for vulnerable populations.

Because access to preventive oral health services is vital to children’s health and

wellbeing, ADHA urges a minimum of $20 million for HRSA’s Oral Health Initiative

so that access to oral health services for Medicaid and SCHIP children will improve

and disparities in oral health status will be lessened. A portion of these monies

would be used to fund important children’s health projects authorized in the ‘‘Children’s Health Act of 2000.’’

ADHA further urges that the Oral Health Initiative receive a separate line item

in the budget. This consolidation into a line item will vastly improve coordination

of HRSA’s various oral health activities.

CENTERS FOR DISEASE-CONTROL DIVISION OF ORAL HEALTH

ADHA would also like to lend its support to the Division of Oral Health within

the Centers for Disease Control (CDC). Specifically, ADHA joins with other dental

groups in urging a budget of $17 million for the Division of Oral Health at CDC.

This funding level will enable the Division of Oral Health to continue its vital work

to control and prevent oral disease, including its important work in the area of community water fluoridation and school-based dental sealant programs as authorized

in the ‘‘Children’s Health Act of 2000.’’

RYAN WHITE HIVAIDS DENTAL REIMBURSEMENT PROGRAM

Included in the Ryan White CARE Act is a dental reimbursement program that

assists in meeting the oral health needs of people living with HIV/AIDS, most of

whose care is not covered under existing federal and state assistance programs. The

dental reimbursement program provides participating institutions with partial reimbursement for the cost of providing oral health care services to low income people

living with HIV and AIDS. In 1999, oral health care was provided to more than

65,000 patients under the program.

The ‘‘Ryan White CARE Act Amendments of 2000’’ would—for the first time—

render dental hygiene programs eligible for the dental reimbursement program.

There are presently 255 accredited dental hygiene education programs in the United

States. In fact, all States, with the exception of Montana, have at least one dental

hygiene education program. Currently, there are 55 dental schools.

Federal support for the provision of oral health services through dental hygiene

programs to HIV positive individuals will not only provide greatly needed oral

health services, but will also afford dental hygiene students important education opportunities. ADHA joins with the American Dental Education Association in recommending $15 million for this important program.

CHIEF DENTAL OFFICER

ADHA further urges that the position of Chief Dental Officer at the Health Care

Financing Administration (HCFA) be made permanent. While this vital position has

historically received funding, it is not now permanent. Given the increasing recognition of the importance of oral health and the key role of HCFA’s Chief Dental Officer, it is imperative that this position be institutionalized.

ALLIED HEALTH

ADHA joins the Allied Health Roundtable in supporting the important work of

Title VII of the Public Health Service Act and recommends 521 million for Allied

Health Project Grants. Allied health disciplines constitute fully 60 percent of the

health care work force. With the acknowledged need for cost-effective health care

providers, it is time to augment funding for and recognition of these important allied health programs. ADHA further encourages funding for federal programs in
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HRSA’s Minority and Disadvantaged Health Professionals Training Cluster. These

important programs recruit and retain minority and disadvantaged students.

MATERNAL AND CHILD HEALTH PROGRAM

Title V Maternal and Child Health (MCH)/Children with Special Health Care

Needs programs have had a history of supporting the public oral health infrastructure, for providing the population-based prevention programs, such as water fluoridation or dental screenings, and for providing direct and enabling oral health services when necessary. Despite this important work, the Maternal and Child Health

program has not enjoyed the level of spending growth over the last ten years that

many other public health programs have realized. ADHA strongly supports the

MCH programs and urges $850 million for fiscal year 2002, which is full funding

at the level authorized last year.

CLOSE

In closing, the American Dental Hygienists’ Association appreciates the important

contributions this Subcommittee has made in improving the quality and availability

of oral health services throughout the country. ADHA is committed to working with

this Subcommittee—and all Members of Congress—to improve the nation’s oral

health which, as Oral Health in America: A Report of the Surgeon General so rightly recognizes, is a vital part of overall health and well-being.

Thank you for this opportunity to submit the views of the American Dental Hygienists’ Association.

PREPARED STATEMENT OF THE AMERICAN LUNG ASSOCIATION (ALA) AND THE

AMERICAN THORACIC SOCIETY (ATS)

The American Lung Association (ALA) and the American Thoracic Society (ATS)

are very pleased that President Bush has committed his Administration to doubling

the NIH budget by fiscal year 2002. To keep the NIH budget on course towards doubling the budget in 2003 will require a 16.5 percent increase in fiscal year 2002.

We look forward to working with this committee to bring the campaign pledges of

President Bush to fruition. Mr. Chairman, while our comments today will focus on

selected parts of the Public Health Service, the American Lung Association and the

American Thoracic Society are firmly committed to appropriate funding for all parts

of our nation’s public health infrastructure.

There are 3 specific issues that ALA/ATS would like to bring to your attention.

SHORTAGE OF PHYSICIAN-INVESTIGATORS

Mr. Chairman while investments in biomedical research at NIH will make tremendous strides in the health of our nation, the ALA/ATS feel there is a fundamental flaw in the research enterprise. That flaw is the shortage of physician-investigators. Physician-investigators are MDs or MD/PhDs who devote a significant

share of their time to conducting research.

Physician-investigators are essential to the research enterprise because they link

the worlds of patient care and bench research. Physician-investigators are best

equipped to translate the needs of the patients they serve into research questions.

The active presence of physician-investigators is essential to keep biomedical research focused on the needs of the patient.

In recent years, the number of new physician-investigators applying for NIH

grants has diminished. NIH must take action to ensure new physician-investigators

are entering the field of research.

Last year, Congress enacted the Clinical Research Enhancement Act. This legislation will take a number of steps to address the shortage of physician-investigators

involved in clinical research. While the legislation is an excellent first step, we feel

the shortage of physician-investigators is not limited to just clinical research but extends to shortages of physician-investigators in all disciplines of biomedical research.

The ALA/ATS recommends Congress continue to support activities called for in

the Clinical Research Enhancement Act, but consider extending the support mechanisms to all physician-investigators. We also recommend NIH raise the low training

stipends paid to students. The $35,000 paid to fifth year post-doctoral students is

extremely low considering the $95,000 average debt physicians have after medical

school.
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National Heart, Lung, and Blood Institute AIDS Budget

Last year, the Administration’s budget proposed to flat fund the AIDS Budget at

the National Heart, Lung, and Blood Institute. Mr. Chairman, as you may know,

opportunistic pulmonary illnesses (like tuberculosis, pneumonia and influenza) are

the leading cause of death for people with AIDS. Adequate funding is needed for

the NHLBI to continue to study the interaction of these illnesses in the lungs of

people with HIV. We are pleased to report that, with the good help of this subcommittee, the National Heart Lung and Blood Institute has increased its investment in investigating the interactions between tuberculosis and HIV.

The ALA/ATS want to thank the committee for its help in bringing attention to

the valuable work done at NHLBI on tuberculosis and AIDS. We hope we can count

on the Subcommittee to continue that interest in this small, but important program.

Fogarty International Center TB Training Programs

The Fogarty International Center at NIH provides training grants to U.S. universities to teach international physicians and researchers AIDS treatment and research techniques. The goal of the program is to develop a cadre of health professionals in the developing world to begin to control the global AIDS epidemic.

Because of the linkage between AIDS and TB infection, FIC has created supplemental TB training grants for these institutions to train international health care

professionals in the area TB treatment and research. This supplemental program

has been highly successful in beginning to create the human infrastructure to treat

the nearly 2 billion people who have TB worldwide.

However, we believe TB training grants should not be offered exclusively to institutions that have received AIDS training grants. The TB grants program should be

expanded and open to competition from all institutions. The ALA/ATS recommend

Congress provide an additional $3 million for FIC to expand the TB training grant

program from a supplemental grant to an open competition grant.

MAGNITUDE OF LUNG DISEASE

This year over 350,000 Americans will die of lung disease. Lung disease is third

leading cause of death in the U.S., responsible for one in every seven deaths. More

than 25 million Americans suffer from a chronic lung disease. Lung diseases cost

the U.S. economy an estimated $89.1 billion annually.

Lung diseases represent a spectrum of chronic and acute conditions that interfere

with the lung’s ability to extract oxygen from the atmosphere, protect against environmental or biological challenges and regulate a number of metabolic processes.

Lung diseases include: chronic obstructive pulmonary disease, lung cancers, tuberculosis, pneumonia, influenza, sleep disordered breathing, pediatric lung disorders,

occupational lung disease, sarcoidosis, and asthma. While lung disease encompasses

many illnesses, these comments will focus on two illness, asthma and tuberculosis.

ASTHMA

Asthma is a chronic lung disease in which the bronchial tubes of the lungs become

swollen and constrict, preventing air from getting into or out of the lung. These obstructive spasms of the bronchi are caused by a broad range of environmental triggers that vary from one asthma-sufferer to another.

Asthma is on the rise. A 1998 survey found that an estimated 26 million Americans (8.6 million children under the age of 18) have been told by their doctor they

have asthma. Rates are increasing for all ethnic groups and especially for African

American and Hispanic children. While some children appear to out grow their asthma when they reach adulthood, 75 percent will require life-long treatment and monitoring of their condition.

Asthma is expensive. The growth in the prevalence of asthma will have significant

impact on our nation’s health expenditures, especially Medicaid. Currently, asthma

costs the United States over $8.1 billion in direct medical expenditures. Hospital inpatient visits account for $3.2 billion in asthma expenses. Asthma attacks bring 1.9

million people to the emergency room each year.

Asthma kills. In 1998, 5,438 people in the U.S. died as a result of an asthma attack. That is a 209 percent increase from 1979. A disproportionate share of these

deaths occurred in African American families.

Federal Response to Asthma

The federal response to asthma has three components; research, programs and

planning. We are pleased to report that, with support from the Subcommittee, we

are making progress on all three fronts.
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FEDERAL RESPONSE TO ASTHMA—RESEARCH

As the prevalence of asthma has grown, so has asthma research. Researchers are

developing better ways to treat and manage chronic asthma. Research supported by

National Heart, Lung and Blood Institute (NHLBI) has shown that using

corticosteroids to treat children with mild to moderate asthma is safe and effective.

For several years there had been concern that corticosteriods would stunt the

growth of children who used them. The five-year study showed that children had

a one-year small reduction in their growth rate. But they had normal growth rates

compared with children who did not use corticosteriods for the following 4 years.

Children who used corticosteroids did suffer fewer asthma attacks and fewer trips

to the emergency room.

Genetic research is also providing insights into asthma. Physicians have noticed

that while most people respond well to inhaled beta-agonists—a commonly prescribed drug to treat asthma—some patients do not response or have worse asthma

using inhaled beta-agonists. Researchers in the NHLBI supported Asthma Clinical

Research Network have discovered that a genetic variation in the beta-adrenegric

receptor determines how well asthma patients will respond to inhaled beta-agonists.

This discovery will enable physicians to better target the drugs they proscribe to

treat asthma.

Basic research is also learning more about asthma. Researchers supported by

NHLBI have developed better animal models to allow expression of selected asthmatic genetic traits. This will allow researchers to develop a greater understanding

of how genes and environmental triggers influence asthma’s onset, severity and

long-term consequences.

FEDERAL RESPONSE TO ASTHMA—PROGRAMS

Last year, Congress provided approximately $27 million for CDC to conduct asthma program and tracking activities. CDC will use these funds to conduct asthma

outreach, education and tracking activities. In Ohio, Case Western University and

Rainbow Babies and Children’s Hospital have been awarded funds to conduct an

asthma intervention program. However, at the current level of funding, less than

half the states have funds to respond to asthma. The ALA/ATS recommend that

CDC be provided $50 million to expand its asthma programs.

FEDERAL RESPONSE TO ASTHMA—PLANNING

Last year, Congress enacted legislation that directs the National Asthma Education and Prevention Program (NAEPP) at NHBLI to develop a plan for the federal

government to respond to the growing asthma epidemic in the U.S. The plan will

include recommendations on research, public health, tracking, education and treatment activities. The ALA/ATS supports this planning process and looks forward

sharing the recommendations of the NAEPP Federal Asthma Plan with this Subcommittee in the near future.

IOM Report: Ending Neglect—the Elimination of Tuberculosis in the United States

Mr. Chairman, tuberculosis has been with us since the dawn of time. Tuberculosis

is an airborne infection caused by a bacterium, Mycobacterium tuberculosis (TB). TB

primarily affects the lungs but can also affect other parts of the body, such as the

brain, kidneys or spine.

TB is spread through coughs, sneezes, speech and close proximity to someone with

active tuberculosis. People with active tuberculosis are most likely to spread TB to

others they spend a lot of time with, such as family members or coworkers. It cannot be spread by touch or sharing utensils used by an infected person.

There are an estimated 10 to 15 million Americans infected with latent TB, with

the potential to develop active TB in the future. About 10 percent of these individuals will develop active TB disease at some point in their lives. In 1998, over 18,000

cases of active TB were reported in the United States.

The Institute of Medicine (IOM) recently published a report on how the United

States has responded to tuberculosis. The IOM report documents the cycles of attention and progress toward TB elimination, the periods of insufficient funding and the

re-emergence of TB. The ALA/ATS is pleased to report that, at the moment, TB

rates in the U.S. are on the decline. From a high in 1992 of 26,673 new cases, we

have seen 7 straight years of decline in TB rates.

While declining TB rates is good news, the emergence and spread of multi-drug

resistant TB poses a significant threat to the public health of our nation. Continued

support is need if the U.S. is going to continue progress toward the elimination of

TB.
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The IOM report provides the United States with a road map of recommendations

on how to eliminate TB in the United States. The IOM report identifies needed detection, treatment, prevention and research activities. The American Lung Association and the American Thoracic Society endorse the IOM report and its recommendations. We estimate it will cost $528 million for the CDC Tuberculosis

Elimination Program to implement the IOM report recommendations.

The National Institutes of Health also has a prominent role to play in the elimination of TB. Currently there is no highly effective vaccine to prevent TB transmission. However, the recent sequencing of the TB genome and other research advances have put the goal of an effective TB vaccine within reach. The National Institutes of Allergy and Infectious Disease have developed a Blueprint for Tuberculosis Vaccine Development. ALA/ATS encourage the Subcommittee to fully fund

the TB vaccine effort.

NIOSH—Researching and Preventing Occupational Lung Disease

In 1998, approximately 66,000 Americans died from work-related injuries or illnesses; 392,000 newly diagnosed cases of occupational illnesses and 5.5 million nonfatal work injuries were reported. Workplace illness and injury will cost the U.S.

economy $171 billion this year.

To protect the health of our nation’s workforce will require research, training,

tracking and new technologies. The ALA/ATS recommend that the Subcommittee

provide a $50 million increase for the NIOSH budget including $25 million for the

NIOSH National Occupational Research Agenda (NORA). NORA represents a partnership research plan for occupational disease. The NORA agenda was developed

with input from labor, business and the health community.

A recent IOM Report—‘‘Safe Work in the 21st Century: Education and Training

Needs for the Next Decades Occupational Safety and Health Personnel,’’ identified

a growing shortage of trained occupational health professionals in the United

States. Unlike the majority of medical subspecialties, occupational health professionals do not receive Medicare training support. We recommend $10 million to increase training opportunities for occupational health professionals. The ALA/ATS

believe more funds are needed to track the incidence of serious work-related illnesses and injury. We recommend $10 million for surveillance data on workplace

safety.

LUNG-DISEASE OPPORTUNITIES AND ADVANCES

Previously, the ALA/ATS reported that NHLBI-supported researchers found that

retinoic acid can reverse the effects of emphysema in laboratory rats. The ALA/ATS

is pleased to report that studies have gone from rats to non-human primates and

that results continue to be encouraging. NHLBI is taking steps to test retinoic acid

treatment in people. We appear to be one step closer to finding a way to reverse

the effects of emphysema—what was once considered an irreversible, debilitating

disease.

NHLBI and Medicare are continuing to investigate the efficacy of the Lung Volume Reduction surgery in the National Emphysema Trial (NET). This clinical trial

will help evaluate the best combination of surgical and rehabilitation therapy for

people with emphysema.

NHLBI is continuing its support for sleep-related research. It has been observed

that people who suffer from inadequate sleep appear to recover more slowly from

infections. NHLBI is supporting research to better understand the genetic basis of

sleep-immune interactions.

NHLBI-supported researchers have made strides in understanding the health effects sleep apnea and have identified genes in dogs that cause narcolepsy. The discovery of the narcolepsy gene in dogs will help guide further research in humans.

Researchers have discovered a genetic defect that may cause familial primary pulmonary hypertension (PPH) in humans. PPH is a rare but serious disease in which

blood pressure in the pulmonary artery becomes extremely high. Discovering the

gene for familial PPH will help researchers discover the cause of this rare and fatal

disease and should lead to improved treatments for PPH.

In conclusion, Mr. Chairman, lung disease is a growing problem in the United

States. It is America’s number three killer, responsible for one in seven deaths. The

lung disease death rate continues to climb. Overall, lung disease and breathing

problems constitute the number one killer of babies under the age of one year.

Worldwide, TB kills 3 million people each year, more people than any other single

infectious agent. Mr. Chairman, the level of support this committee approves for

lung disease programs should reflect the urgency illustrated by these numbers.
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PREPARED STATEMENT OF THE AMERICAN GASTROTENTEROLOGICAL ASSOCIATION

SUMMARY OF RECOMMENDATIONS

The American Gastroenterological Association (‘‘AGA’’) urges Congress to increase

funding for medical research on digestive diseases and disorders through budgetary

increases to the National Institutes of Health (‘‘NIH’’), the Centers for Disease Control and Prevention (‘‘CDC’’), and the Agency for Healthcare Research and Quality

(‘‘AHRQ’’).

Specifically, AGA encourages Congress to provide at least a 16.5 percent increase over fiscal year 2001 for NIH, raising the funding levels from $20.3 billion to $23.7

billion, as recommended by the Ad Hoc Group for Medical Research Funding. Within NIH, AGA recommends at least a commensurate increase for the National Institute of Diabetes and Digestive and Kidney Diseases (‘‘NIDDK’’), the National Cancer

Institute (‘‘NCI’’), and the National Institute of Allergy and Infectious Diseases

(‘‘NIAID’’), each of which support a considerable portfolio of gastrointestinal research. These increases would allow for further research on the diagnosis, treatment

and cure for debilitating and devastating digestive diseases.

AGA also urges Congress to increase funding over fiscal year 2001 by 29 percent to $5.0 billion for the CDC as recommended by the CDC Coalition, and by 40 percent to $400 million for AHRQ as recommended by the Friends of AHRQ.

MEDICAL RESEARCH RECOMMENDATIONS

AGA is the nation’s oldest, not-for-profit specialty medical society, consisting of

over 11,000 gastroenterologic physicians and scientists who are involved in research,

clinical practice, and education on disorders of the digestive system. As the nation’s

leading voice on gastrointestinal research, AGA is uniquely qualified to advise Congress on the current status of federally-supported digestive disease research programs and the areas in need of further research.

Each year more than 62 million Americans are diagnosed with digestive disorders.

Among the more common are obesity, gastrointestinal cancers, inflammatory bowel

disease, motility disorders and foodborne illness. This testimony focuses on these serious health problems and makes recommendations on how Congress should allocate

this country’s precious medical research dollars to combat digestive diseases.

Nutrition and Obesity

110 million adults in this country are either overweight (61 million) or obese (49

million); 31.3 percent of men and 34.7 percent of women are considered to be clinically obese; one in five children are clinically obese. The number of obese adults in

the United States has doubled in the last 25 years.

The costs to society are both direct and indirect, and include increased medical

expenses, loss of productivity in the workplace, disability claims and job discrimination. Approximately 300,000 adult deaths in the United States each year are attributable to obesity.

Obesity is a major health problem in the United States because of its marked

prevalence, causal relationship with serious medical diseases and considerable economic impact. Obesity is a major cause of gastrointestinal diseases such as gall

bladder disease, liver disease (including cirrhosis of the liver), and colorectal cancer.

Treatment of obesity and diseases directly related to it accounts for 5 percent to 7

percent of total health care costs annually.

Despite the fact that obesity is gaining more recent attention, a significant

amount of ground must be covered before medical research catches up with the need

to address the problem in a comprehensive manner. There are a growing, but inadequate, number of grants being funded to examine this disease.

AGA recommends that Congress urge NIDDK, the National Institute of Child

Health and Human Development, the Office of Research on Women’s Health and the

Center for Research on Minority Health to increase RO1 funding for obesity research by 15 percent for fiscal year 2002 and to encourage the institutes to consider

RFA’s on the effects of obesity on gene expression, particularly as it relates to GI

cancers, including colon cancer. Additionally, research into the effect of diet and nutrient intake on mucosal function, metabolism and gene function will provide insight

into how nutrients affect gut function. Furthermore, the institutes should increase

advanced research training at the basic level (KO8) and clinical level (K23) by 25

percent in fiscal year 2002.

Gastrointestinal Cancers

Approximately 226,600 new cases of gastrointestinal cancers will be diagnosed

this year. Sadly, 129,800 Americans will die from these cancers. The most common

cancers involve the colon/rectum, stomach/esophagus, and pancreas.
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—Colorectal cancer is the second leading cause of cancer-related deaths in the

United States and ranks fourth as the most common cancer.—70 percent to 80

percent of colorectal cancer cases involve average-risk individuals. If diagnosed

early, this cancer is highly curable. As such, research and early detection

through screening remains the key to preventing, treating, and curing this disease. We encourage Congress to require coverage for screening for all Americans. Further, we urge Congress to support additional research on colorectal

cancer. —Pancreatic cancer will be diagnosed in 28,300 Americans in 2001 with 28,200

people projected to die from this disease.—It is a highly lethal form of cancer

with the lowest survival rate among all major malignancies. —Of increased concern to AGA are esophageal and stomach cancers. These are the

second most common gastrointestinal cancers.—It is projected that nearly 34,000

Americans will be diagnosed and more than 25,100 will die in 2001 from these

cancers. Of heightened concern to AGA is Barrett’s esophagus, a precursor to

esophageal cancer, and the relationship between Barrett’s and chronic

gastroesophageal reflux disease (‘‘GERD’’).

AGA applauds the NCI for its commitment to improving the understanding of,

and seeking cures to, these and other gastrointestinal cancers. However, more research is needed. Congress should encourage the NCI to likewise establish a

Progress Review Group on espohgeal and stomach cancers. Congress also should

urge the NIDDK to augment its efforts in these areas, and to particularly focus resources on the genetic aspects of these cancers, diagnostic tests for genetic abnormalities and prevention of these cancers, the modulation and understanding of

epithelial injury and repair the environmental factors relating to the development

of these diseases, and the development and treatment of Barrett’s Syndrome in patients with GERD.

Most cases of these cancers are detected too late to be effectively treated. However, CDC’s National Colorectal Cancer Screening Awareness program is helping to

inform the public that early detection through regular screening is important. Congress should support CDC’s Colorectal Cancer Screening Awareness program with

$15 million in fiscal year 2002, an increase of $6 million over fiscal year 2001.

Inflammatory Bowel Disease

It is estimated that 1 million Americans have inflammatory bowel disease (‘‘IBD’’).

Although older and younger people may also develop this disease, IBD usually begins between the ages of 15 and 40 and persists throughout life with remissions.

People with IBD experience abdominal pain, fever, bowel sores, intestinal bleeding,

anorexia, weight loss, fullness, diarrhea, constipation, and vomiting. In severe cases,

the patient can hemorrhage or contract sepsis/toxemia resulting in death.

Studies on the cause of IBD are desperately needed in order to have a better understanding of the disease and work towards more effective management and treatment. Specifically, AGA recommends that NIDDK support genomic research aimed

at identifying abnormal genes in persons with IBD and finding the causes of IBD.

Motility Disorders

It is estimated that up to 30 percent of all Americans may be affected at some

time during their lives by motility disorders. Irritable bowel syndrome (‘‘IBS’’), the

most common motility disorder, is especially troubling because a patient does not

present with any pathognomonic symptoms or laboratory findings of the disease,

making diagnosis and treatment extremely difficult.

Further research is needed in this area both due to the high prevalence of this

disease as well as the lack of knowledge on how to identify, diagnose, and cure the

disease. AGA urges Congress to direct the NIDDK to focus additional resources on

IBS. Specifically, AGA recommends that NIDDK support research into the development of physiologic tests to characterize the phenotypic subgroups of functional gastrointestinal disorders, including non-ulcer (functional) dyspepsia, functional constipation, and irritable bowel syndrome (motility). Additionally, AGA urges Congress

to also encourage the Office of Research on Women’s Health to devote more of its

attention to these areas of research in light of the high incidence of IBS among

women.

Foodborne Illness

Foodborne illnesses are estimated to cost annually $5 to $6 billion in direct medical costs and productivity losses. Due to poor reporting of foodborne incidents, experts vary on the number of Americans affected annually from a conservative 6 million to over 80 million.

AGA recommends that Congress encourage the NIH, including NIDDK and

NIAID, and others conducting foodborne illness research like the United States De-
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partment of Agriculture (‘‘USDA’’) and the CDC to concentrate more intensively on

research into treatments for foodborne illness. AGA thus urges NIDDK and NIAID

to support research on (1) intestinal diseases caused by combination of luminal (including bacterial), environmental, and genetic factors with an emphasis on inflammatory bowel diseases, and (2) the reaction of the gut to foodborne pathogens, including research on the pathogenesis of the disease, the reaction of the gut to infections, the development of animal models to test therapies, and the invention of vaccines or substances that bind with the toxins to prevent the illness.

MEDICAL RESEARCH INFRASTRUCTURE

Digestive Disease Research Centers

Digestive Diseases Research Core Centers are key to establishing strong research

networks and advancing medical knowledge. Currently, fourteen fully funded centers exist which conduct basic and clinical research on a variety of digestive disorders. They have been highly successful in expanding medical knowledge on a variety of GI diseases and disorders. AGA urges Congress to instruct NIDDK to expand

the number of centers by adding one new 5-year center in each of the next 2 years

such that sixteen centers are fully supported. These new centers should focus on

genomic and proteomic approaches to gastrointestinal research. Moreover, NIDDK

should maintain full funding for those centers already in existence.

Small Equipment Grants

As technology continues to evolve, laboratory research equipment is becoming

more expensive to purchase and maintain. NIH’s current Shared Instrumentation

Grant Program offers equipment grants for which researchers can apply for equipment with a minimum cost of $100,000; appropriate for use in replacing pieces of

large equipment. However, a similar grant program does not exist to assist researchers in replacing less expensive ($50,000–$100,000), often highly utilized,

pieces of equipment. Researchers’ small equipment needs are just as critical as larger pieces of equipment and the cost of replacing such instrumentation can be prohibitively expensive to support on a single grant application. Therefore, AGA urges

Congress to suggest that NIH study the need for a small equipment grant program

comparable to the existing Shared Instrumentation Grant Program.

Training of Physician-Scientists

While research has expanded our medical knowledge and enabled physicians and

other providers to better prevent diseases, diagnose disorders, and treat people,

there is growing concern that the number of physician-scientists (e.g., investigators

who have medical degrees) is declining and that this decline will negatively impact

many key future research endeavors. A recent study documenting this decline points

to the tremendous debt incurred by medical school graduates who have more lucrative options outside of research as a primary cause. See Tamara R. Zemlo et al.,

The Physician-Scientist: Career Issues and Challenges at the Year 2000, 14 The

FASEB Journal 221–230 (2000).

AGA views this problem as an immediate and serious threat to the future of biomedical research generally, and gastrointestinal research in particular. To alleviate

this growing problem, AGA urges Congress to increase funding for the continued expansion of clinical research and clinical research training opportunities. To achieve

this Congress should take the following steps: career support for established clinical

investigators, especially to enable them to mentor new investigators; and appropriate funding to NIH for the implementation of the loan repayment provisions of

the Clinical Research Enhancement Act.

NIH Budget Doubling Initiative

Medical research endeavors and America’s patients have benefited tremendously

from the 5-year effort to double the NIH budget. However, researchers recognize

that there may be ramifications once the NIH budget has been doubled, and annual

funding increases return to pre-initiative levels. It is imperative that Congress not

permit NIH funding to stagnate upon achieving the goal doubling the NIH budget.

Therefore, in order to prevent a funding crisis that results in a retreat from the significant progress that has been made, AGA recommends that Congress plan for the

post-doubling period accordingly. Additionally, Congress should applaud NIH for

working to develop a funding strategy for post-fiscal year 2003, encourage further

budget modeling exercises at NIH, and afford NIH the maximum amount of flexibility to address post-budget doubling funding levels.
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CONCLUSION

The diseases described above continue to take a huge toll on America’s health and

economy. Congress must keep up the momentum it has started, and in some cases,

devote even more resources. AGA appreciates the opportunity to present its views

on the fiscal year 2002 appropriations. Please call Michael Roberts, Vice President

of Public and Government Relations at AGA, at (301) 941–2618 if you have further

questions.

PREPARED STATEMENT OF THE AMERICAN HEART ASSOCIATION

It is highly likely that heart attack or stroke will cause your death or disability

or that of a loved one. Heart attack, stroke and other cardiovascular diseases remain America’s leading cause of death and a major cause of disability. Cardiovascular diseases account for nearly 1 of every 3 deaths in the United States.

The American Heart Association works to reduce death and disability from heart

attack, stroke and other cardiovascular diseases. We commend this Committee for

making fiscal year 2001 funding for the National Institutes of Health and for the

Centers for Disease Control and Prevention a priority. But, we are concerned that

our government is still not devoting sufficient resources for research and prevention

to America’s No. 1 killer—heart disease—and to our country’s No. 3 killer and a

leading disabler—stroke.

STILL NUMBER ONE

Heart attack, stroke and other cardiovascular diseases have been America’s No.

1 killer since 1919. Nearly 61 million Americans—1 in 5—suffer from one or more

of these diseases. Americans of all ages! Also, hundreds of millions of Americans

have major risk factors for these diseases—about 50 million have high blood pressure, 41 million adults have elevated blood cholesterol (240 mg/dL), 49 million

adults smoke, 107 million adults are overweight or obese and 10 million have physician-diagnosed diabetes. As the baby boomers age, the number of Americans afflicted by these lethal and disabling diseases will increase substantially. Cardiovascular disease costs Americans more than any other disease. Americans will pay

an estimated $300 billion for cardiovascular-related medical costs and lost productivity in 2001. These diseases constitute 4 of the top 5 hospital costs for all payers,

excluding childbirth and its complications, and 4 of the top 5 Medicare hospital

costs. Heart disease is also the major cause of premature, permanent disability of

American workers, accounting for nearly 20 percent of Social Security disability payments.

HOW YOU CAN MAKE A DIFFERENCE

Now is the time to capitalize on a century of progress in understanding heart attack, stroke and other cardiovascular diseases. According to an expert panel supported by this Committee, America’s progress in reducing the death rate from cardiovascular disease has slowed, suggesting that new strategies against these killers

are needed. The panel also reported that there are striking differences in cardiovascular death rates by race/ethnicity, socioeconomic status and geography. But

promising, cost-effective breakthroughs in treatment and prevention are on the horizon. If you stay the course to double NIH funding by fiscal year 2003, the support

of heart and stroke research and of the translation of that research into effective

clinical and community initiatives will cut health care costs and improve the quality

of life. For fiscal year 2002, we urge you to do the following:

—Appropriate $23.7 billion (a 16.5 percent increase over fiscal year 2001 funding)

for the NIH—the fourth step toward the bipartisan goal of doubling NIH’s budget by fiscal year 2003.—NIH research provides new treatment and prevention

strategies, cuts health care costs, creates jobs and maintains America’s status

as the world leader in the biotechnology and pharmaceutical industries.

—Provide at least a 16.5 percent increase over fiscal year 2001 funding for NIH

heart and stroke research.—Researchers are on the brink of advances to greatly

enhance prevention and to provide new treatments so you and your loved ones

can be spared the pain and suffering of heart disease and stroke.

—Allot $50 million for CDC’s Cardiovascular Health Program to expand this initiative to 35 states.—Science must be made applicable through community programs that encourage Americans to make healthful lifestyle choices to prevent

heart disease and stroke.

—Support $12.5 million to continue to help rural communities buy automated external defibrillators (AEDs) and to train rural emergency responders, including
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police and fire personnel, to use them.—Rural Access to Emergency Devices Act

is part of Public Law 106–505, Public Health Improvement Act.

HEART AND STROKE RESEARCH BENEFITS ALL AMERICANS

Thanks to advances in addressing risk factors and in treating cardiovascular diseases, more Americans are surviving heart disease and stroke. Heart disease and

stroke research and prevention breakthroughs are saving and improving lives. Several examples follow. —Stents.—Each year nearly 1 million Americans undergo angioplasty to widen

their narrowed arteries to the heart. But, within six months, 35 percent of

angioplasties must be repeated because the artery narrows again. In a major

change in patient care, stents (wire mesh tubes used to prop open an artery)

are now used in nearly 80 percent of angioplasties. The use of stents along with

angioplasty has significantly reduced the incidence of artery renarrowing within

six months. —Surgery to Reduce Risk for Stroke.—In many cases, surgeons can prevent stroke

by removing the buildup of plaque when one of the main arteries to the brain

is severely narrowed. Research has better defined the group of patients in

whom this surgery is most helpful. About 121,000 such procedures are performed each year. —State-of-the-Art Life-Extending Drugs.—Research has produced amazing new

drugs to help prevent and treat heart disease and stroke. Cutting-edge drugs

to control blood pressure and cholesterol are more effective than ever in saving

lives and enhancing life quality of millions of Americans. Some of these drugs

can prevent both heart attack and stroke. When prevention fails, revolutionary

‘‘clotbuster’’ drugs, such as tPA, can reduce disability from heart attack by dissolving blood clots causing the attack. In stroke, the use of tPA, within 3 hours

of the onset of symptoms, can restore blood flow and reduce chances of permanent disability by 33 percent, saving health care costs. TPA offers hope for the

estimated 1.1 million Americans who will suffer a heart attack and the 450,000

who will have a clot-based stroke this year.

So Americans can continue to benefit from these types of breakthroughs, it is critical that we proceed toward doubling the overall NIH budget by fiscal year 2003.

We advocate an fiscal year 2002 appropriation of $23.7 billion for the NIH, the

fourth step toward the doubling goal. We have a particular interest in individual

NIH components that relate directly to our mission of reducing heart attack, stroke

and other cardiovascular diseases. Our funding recommendations for these institutes, centers and programs follow.

HEART RESEARCH CHALLENGES AND OPPORTUNITIES FOR NHLBI

The above and other advances have been made possible by more than 50 years

of American Heart Association-sponsored research and more than a half-century of

investment by Congress in the National Heart, Lung, and Blood Institute. Thanks

to research, more of our patients, our families, and our friends survive their heart

attack or stroke and with a better quality of life. However, while more Americans

are surviving, heart attack and stroke are still our No. 1 and No. 3 killers, respectively, and can cause permanent disability, requiring costly medical care and loss

of productivity and quality of life. Clearly more work is needed if we are to win the

fight against heart disease and stroke.

We urge this Committee to double the NHLBI budget, including heart initiatives,

by fiscal year 2003. As the next step toward reaching this goal, we advocate an fiscal year 2002 appropriation of $2.679 billion for the NHLBI, with $1.650 billion for

heart and stroke-related research. A funding level of this amount will allow NHLBI

to expand existing programs and invest in promising new initiatives. Several challenges and opportunities to advance the battle against heart disease are highlighted

below.

—Advanced Imaging.—Research has revolutionized imaging technology to diagnose heart disease. About 1.3 million Americans in 1998 were hospitalized for

an angiogram, an X-ray picture of blood vessels that can demonstrate

narrowings in arteries that can lead to heart attacks or strokes. Because

angiograms are associated with some discomfort, the risk of infection and bleeding, and in rare cases, heart attack or stroke; there is strong motivation to replace them with easier, safer and cheaper imaging procedures. Considerable

progress has been made. The high speed CT scan takes pictures that produce

a measure of blockages in arteries to the heart, and helps doctors better tailor

treatments. Three-dimensional coronary magnetic resonance angiography uses

strong magnets to provide detailed images of the arteries to the heart. In less
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than an hour, an MRA evaluates heart anatomy and other heart functions, providing an accurate and thorough, non-invasive examination.

—Bone Formation and Calcification in Cardiovascular Diseases.—Calcium is an

early marker of atherosclerosis involving the arterial wall. Evidence suggests an

association between bone formation, repair and breakdown (e.g. osteoporosis)

and development of heart disease and other cardiovascular diseases. For instance, patients who take statin drugs—effective in lowering cholesterol levels

and in reducing cardiovascular disease risk—are at decreased risk for bone fractures. Conversely, several studies have reported that people with low bone mass

may have an increased risk of developing or dying from cardiovascular diseases.

These results indicate that basic research in this area may result in strategies

to prevent osteoporosis and cardiovascular diseases.

—Heart Attack, Stroke and Other Cardiovascular Diseases in Women.—Cardiovascular diseases are a major cause of disability and the No. 1 killer of American women, killing more women than the next 14 causes of death combined.

About 1 in 5 women live with effects of cardiovascular diseases. The clinical

course of cardiovascular disease is different in women than in men and our diagnostic capabilities are less accurate in women than in men. After a woman

develops cardiovascular disease, she is more likely than a man to have continuing health problems and is more likely to die. But these diseases are largely

unrecognized by both women and their doctors. Extra funding is needed to allow

NHLBI to expand cardiovascular disease research in women and to create more

educational programs for patients and health care providers on cardiovascular

diseases risk factors, as authorized under Public Law 105–340, Women’s Health

Research and Prevention Amendments.

—Resuscitation Research.—Some 1,000 Americans die each day from unsuccessful

cardiopulmonary and trauma resuscitation. The National Heart, Lung, and

Blood Institute, the National Institute of Neurological Disorders and Stroke, the

National Institute of Child Health and Human Development, the National Institute of General Medical Sciences, the Department of Defense, and the Food and

Drug Administration sponsored a forum to set a broad research agenda on

promising and novel life-saving therapies and to identify promising new directions in CPR and trauma resuscitation research.

STROKE RESEARCH CHALLENGES AND OPPORTUNITIES FOR NINDS

A major cause of permanent disability and a key contributor to late-life dementia,

stroke is America’s No. 3 killer. Many of our 4.5 million stroke survivors face debilitating physical and mental impairment, emotional distress and huge medical costs.

About 600,000 Americans will suffer a stroke this year. Considered a disease of the

elderly, stroke also strikes newborns, children and young adults.

We urge a doubling of the NINDS stroke budget by fiscal year 2003. An fiscal

year 2002 appropriation of $1.371 billion for NINDS, with $151 million for stroke

initiatives, would be the next step toward the goal. This will allow the NINDS to

expand studies and start new initiatives to prevent stroke, protect the brain during

stroke and enhance rehabilitation. Some challenges and opportunities follow.

—Strategic Stroke Research Plan.—As a result of report language provided by this

Committee during the fiscal year 2001 appropriations process, NINDS is developing a 5-year strategic stroke research plan. Researchers, clinicians, pertinent

organizations and advocacy groups will identify existing gaps in knowledge and

areas ripe for advances. Expected to be released in fall 2001, the plan will

strongly stimulate stroke research.

—Emerging Stroke Risk Factors.—More Americans are controlling major stroke

risk factors, such as high blood pressure and smoking, yet the number of people

falling victim to stroke continues to rise. Scientists are defining new stroke risk

factors, re-examining existing ones and reconsidering the long-held belief that

no difference exists in risk between young and older patients with similar risk

factors. Researchers are studying heart valve disease, irregular heartbeats, the

role of inflammation in clogging of arteries, and the long-term effects of previous high blood pressure. Increased funding to study these areas may lead to

new ways to prevent stroke.

—Therapeutic Strategies for Stroke.—Several major clinical trials have identified

new methods for preventing and treating stroke in high-risk populations. However, with the increased number of strokes, and with the disparities evident in

the treatment of stroke, new ways to prevent strokes, to raise awareness, and

to better treat strokes need to be developed and evaluated. Funding for new

clinical studies is crucial for developing cutting-edge stroke treatment and prevention.
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—Stroke Education.—Less than 5 percent of those eligible for tPa—the only approved emergency treatment for clot-based stroke—receive it. As a member of

the Brain Attack Coalition, comprised of organizations committed to fighting

stroke, we work with the NINDS to increase public awareness of stroke symptoms and to call 9–1–1. Together, we sponsor and distribute a televised public

service announcement and are striving to develop systems to make tPA readily

available to appropriate patients. When these measures are fully implemented,

stroke treatment will change from supportive care to early brain-saving intervention. More funding is needed to educate the public and health professionals

about stroke.

RESEARCH IN OTHER NIH INSTITUTES BENEFIT HEART & STROKE

The National Institute on Aging defines how the aging process contributes to cardiovascular diseases, a main disabler and No. 1 killer of older Americans. An fiscal

year 2002 appropriation of $80.675 million for cardiovascular research will allow

continuation of studies and expansion into promising areas of investigation.

The National Institute of Diabetes and Digestive and Kidney Diseases studies

help in reducing cardiovascular disease death and disability. We advocate an fiscal

year 2002 appropriation of $1.548 billion for the NIDDK to advance research to help

diabetics, 2/3 of whom die from heart disease or stroke.

The National Institute of Nursing Research studies play a key role in promoting

self-care and patient education. NINR research is key to primary and secondary prevention of heart attack, stroke and other cardiovascular diseases. We advocate an

fiscal year 2002 appropriation of $121.591 million for NINR.

Animal research and nationally-supported clinical research at the local level are critical for heart and stroke research. We support an appropriation of $952.358 million for the National Center for Research Resources. Increased resources will fortify

animal research, help correct deficiencies in animal research resources and

strengthen nationwide General Clinical Research Centers and Biomedical Technology and Infrastructure Areas.

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

The lead health care quality agency, AHRQ acts as a ‘‘science partner’’ with public

and private health care sectors in improving health care quality, reducing health

care costs and broadening access to essential services. AHRQ is an active participant in developing evidence-based information needed by consumers, providers,

health plans and policymakers to improve health care decision making. We advocate

an appropriation of $400 million for the AHRQ to improve health care quality, reduce medical errors and expand the availability of health outcomes information.

CENTERS FOR DISEASE CONTROL AND PREVENTION

Prevention is the best way to protect Americans’ heath and ease the huge financial burden of disease. Commitment cannot stop at the laboratory door. Resources

must be made available to bring research to places where heart disease and stroke

live—the towns and neighborhoods of America.

CDC sets the pace on prevention. It builds a bridge between what we learn in

the lab and how we live in communities. We advocate an fiscal year 2002 appropriation of $5 billion for CDC, with a $350 million increase for chronic disease prevention.

As a result of this Committee’s support since fiscal year 1998, CDC’s Cardiovascular Health Program now covers 25 states. It allows states to design and/or implement programs to meet local needs to prevent and control heart disease and

stroke. CDC’s 1997 report Unrealized Prevention Opportunities: Reducing the

Health and Economic Burden of Chronic Disease states ‘‘strong chronic disease prevention programs should be in place in every state to target the leading causes of

death and disability—and their risk factors.’’ Until this Committee started the Cardiovascular Health Program, CDC’s Preventive Health and Health Services Block

Grant was the only source of federal funding to states for targeting cardiovascular

diseases, the No. 1 killer in each state. An fiscal year 2002 appropriation of $50 million for the Cardiovascular Health Program will allow CDC to expand it to 10 more

states, to total 35 states.

The Paul Coverdell National Acute Stroke Registry is designed to track and improve delivery of care to stroke patients. CDC is working with an expert panel to

define data points for the registry prototypes. An appropriation of $5 million for the

registry will allow CDC to continue this initiative.

WISEWOMAN builds on CDC’s National Breast and Cervical Cancer Early Detection Program to also screen uninsured and low-income women ages 40–64 for heart
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disease and stroke risk factors. We laud this Committee for providing funding to expand this program up to 15 states. An appropriation of $20 million will allow CDC

to support up to a total of 20 states in WISEWOMAN.

Also, we recommend the following fiscal year 2002 funding levels for the following

CDC programs:

—$210 million for the Preventive Health and Health Services Block Grant;

—$50 million for an extensive nutrition, physical activity and obesity program;

—$35 million for a comprehensive school health education program; and

—$130 million for CDC’s Office of Smoking and Health to build a national program to prevent tobacco use, including a public education campaign to reduce

youth access to tobacco products.

Coupled with a nationwide comprehensive Cardiovascular Health Program, these

initiatives will help the fight against heart disease and stroke. We urge you to make

cardiovascular health a priority.

HEALTH RESOURCES AND SERVICES ADMINISTRATION

About 220,000 Americans die each year from sudden cardiac death—when a

heart’s electrical rhythms malfunction, causing the heart to suddenly stop beating.

Only about 5 percent of the victims live. Small, easy-to-use devices, AEDs can shock

a heart back into normal rhythm and restore life. For each minute the heart beat

is not restored to its normal rhythm, the victim’s chance of survival drops as much

as 10 percent. The first responder to a cardiac arrest may not be a medical responder, so the Rural Access to Emergency Devices Act, part of Public Law 106–

505, Public Health Improvement Act, authorizes up to $25 million over 3 years to

help rural communities buy AEDs and to train emergency responders to use them.

An appropriation of $12.5 million is needed to further implement the rural AED

component.

DEPARTMENT OF EDUCATION

Physical inactivity is a major risk factor for heart disease and stroke. So the grim

decline in daily enrollment in physical education (PE) classes is a key concern. To

address this matter, in fiscal year 2001 Congress appropriated $5 million for the

Physical Education for Progress Act. Under PEP, the Education Secretary can

award grants to start, expand and improve PE for kindergarten through grade 12.

Funds can be used to buy equipment, develop curriculum, hire and/or train staff and

support other efforts so students can participate in PE. We advocate an appropriation of $70 million for PEP in fiscal year 2002.

ACTION NEEDED

Significantly increasing funding for research and community programs will allow

us to continue making strides in the battle against heart disease and stroke. Our

government’s response to this challenge will help define the health and well being

of Americans in this new millennium.

PREPARED STATEMENT OF THE AMERICAN PSYCHOLOGICAL SOCIETY

SUMMARY OF RECOMMENDATIONS

As a member of the Ad Hoc Group for Medical Research Funding, APS recommends $23.7 billion for NIH in fiscal year 2002 as the 4th installment of the 5-

year doubling plan.

APS requests Committee support for increased behavioral and social science research and training at NIH in order: to better meet the Nation’s health needs—

many of which are behavioral in nature; to realize the exciting scientific opportunities in the fields of behavioral and social science research; and to accommodate the

changing nature of science, in which new fields and new frontiers of inquiry are rapidly emerging. Specifically, we ask that you help make behavioral research more of

a priority at NIH, both by providing maximum funding for those institutes where

behavioral science is a core activity, and by encouraging NIH to advance a model

of health that includes behavior in deciding its scientific priorities.

Specific Committee support is requested for behavioral science activities at a number of individual institutes and examples are provided to illustrate the exciting and

important behavioral and social science work being supported at NIH.

Mr. Chairman, Members of the Committee: On behalf of our members, I want to

thank this committee for your leadership in the bipartisan effort to double the NIH

budget. As a member of the Ad Hoc Group for Medical Research Funding, the Amer-
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ican Psychological Society recommends $23.7 billion for NIH in fiscal year 2002 as

the 4th installment of the 5-year doubling plan. The rationale for these aggressive

increases remains as compelling today as it was in fiscal year 1999, the first year

that you and your colleagues in the House embarked on this path. Our Nation’s

health needs, scientific opportunities, and the changing nature of health research

all warrant this expansion. I will talk about these three areas in terms of the field

that I represent, which is behavioral and social science research—specifically, psychological science research.

Health Needs.—The effects of behavior on health have been widely documented.

Behavior is as threatening as any genetic or biological condition. When you look at

what determines health, you can’t help but notice behavior. Smoking, drinking, taking drugs—all begin as behaviors. And many other leading health concerns are behavioral in origin or in their manifestation: Heart disease, lung disease, diabetes,

mental illness, developmental disabilities, brain injury, AIDS, and so many more

cannot be fully understood without studying the behavioral and psychological factors

involved in causing, treating and preventing them.

Scientific Opportunities.—Many of the 15,000 people who belong to APS are scientists at our Nation’s leading universities and colleges, conducting research and

training supported by NIH. The behavioral research enterprise at NIH spans from

theoretical to applied, from basic to clinical. Virtually every institute at NIH supports some amount of psychological science. Examples include investigations into:

The connections between the brain and behavior; the basic processes of cognition

and memory; social interaction in people of all ages; the interactions of such things

as emotion, stress, and psychophysiology and their impact on health; research into

how children grow and develop; management of debilitating chronic conditions such

as diabetes and arthritis as well as depression and other mental disorders; and the

behavioral aspects of smoking and drug and alcohol abuse, to find ways people can

escape addiction. These topics represent some of the most exciting research frontiers

today, and our field is poised to make significant strides in a number of scientific

areas that a few years ago didn’t even exist.

Changes in the Nature of Research.—If we didn’t know it before, the recent publicity surrounding the sequencing of the human genome has hit home the notion

that we are in a new era of science. In the flurry of interviews and opinion pieces

that followed the recent publication of human genome research articles, leaders of

the human genome projects and other scientists have repeatedly stressed that genes

alone cannot explain complex behavior or account for all risks for developing a particular physical or mental illness or for behavioral problems. They consistently caution against the notion that genes determine behavior. As noted by Robert Plomin,

a distinguished APS Fellow and pioneer in the field of behavioral genetics, the influence of genes on behavior is ‘‘probabilistic, not deterministic.’’

The implications of mapping the human genome are enormous for psychological

research. Psychologists and other behavioral scientists already are asking such

questions as: How do the effects of specific genes unfold in behavioral development?

How do they interact with experience and other environmental factors? In other

words, now that we have genes, how do they work?

As just one example of what I mean, psychologists soon may be able to use genes

to better target behavioral interventions to the people who need them most—to tailor our interventions to those at highest genetic risk. For example, if we learn that

certain genes put children at risk for behavioral disorders, say anorexia, depression,

or even for diabetes, then those are the children for whom we need to develop specific prevention strategies. For diabetes, this may mean a much more aggressive approach to diet, weight control, and a program to maintain compliance with taking

medication, an often-ignored but critically important and totally behavioral part of

managing a disease. What this requires, however, is that at the same time we are

trying to understand how genes influence behavior, we need to more systematically

study the behavior itself and use that information to develop more targeted interventions.

The emergence of fields such as behavioral genetics draws from the progress made

both in genetics and behavioral research, and illustrates the seamless connection between behavior and biology—a continuum we would like to see NIH promote more

than it does now. Cognitive neuroscience, the combined approach of mapping the

brain’s psychological functioning onto its physical and biological functioning, is another such area. Unfortunately, NIH’s research and training policies sometimes

make it appear as if there is an artificial distinction between the behavior and biology. There is excellent behavioral science work being done at NIH, producing quality knowledge and breakthroughs that should be a source of enormous pride for

NIH. But too often in the NIH model, behavior is ignored, particularly basic behavioral research. It isn’t until a person gets lung cancer, emphysema, heart disease,
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liver damage, brain damage, that behavior is thought of. As important as the molecular and cellular origins of these problems are, the behavioral origins are equally

important. For example, how do the basics of learning, memory, perception, emotion,

or even social development interact with the biology of various diseases? The answer

is, there is a great deal of interaction among these factors. Almost none of the disorders NIH addresses can be fully understood without also understanding their behavioral dimensions.

Mr. Chairman, I ask you and the Committee to give your fullest consideration to

these concerns as part of your deliberations on the fiscal year 2002 budget for NIH.

Specifically, we ask that you help make behavioral research more of a priority at

NIH, both by providing maximum funding for those institutes where behavioral

science is a core activity, and by encouraging NIH to advance a model of health that

includes behavior in deciding its scientific priorities.

Training: A Return on the Investment.—When discussing the budget for NIH and

other federally-funded science agencies, we often talk in terms of investment—putting money into activities where the return will be realized somewhere down the

road. In providing research grants, sometimes we don’t know when or even whether

there will be a significant payoff—we have an extensive review system that helps

minimize the likelihood of a washout, but still, the outcomes of science are unpredictable.

One part of science where the investment is almost guaranteed to payoff is in the

area of training. We know that if we provide support now for a young investigator,

we will have a well-trained, highly-qualified scientist as a result. We also know that

without training, we will not have an adequate pool of researchers to pick up where

preceding generations leave off. Supply is a critical issue in behavioral science at

NIH. Right now, NIH institutes are competing for a comparatively small pool of behavioral science researchers. In fact, we are seeing some institutes with new or expanding behavioral science programs enticing senior behavioral grantees from sister

institutes, leaving the ‘‘old’’ institutes with critical gaps in their portfolios.

To address this problem, institutes need to ‘‘grow their own’’—the responsibility

for training behavioral scientists should be shared across all of the institutes because of the role of behavior in virtually all of the major health issues being addressed by NIH. Toward this end, several institutes have established B/START (Behavioral Science Track Awards for Rapid Transition) programs of small grants to

encourage newer behavioral science investigators. This has proved to be an effective

mechanism and should be used across NIH.

But training shouldn’t be just an issue of supply and demand. As I noted earlier,

health needs should be the most important factor in determining our research and

training priorities. In behavioral and social science research, training is essential

not only to ensure future supply of scientists, but also to ensure that our Nation’s

best minds are working on the issues that are most directly linked to health.

Dozens of reports from the National Research Council and the Institute of Medicine have recommended increased training for health and behavior research. One

such report, Bridging Disciplines in the Brain, Behavioral and Clinical Sciences,

notes that ‘‘newly emerging health problems, as well as those that have plagued us

over time, are proving to be surprisingly complex as scientists and health care providers begin to recognize the intricate interplay among environment, behavior and

disease.’’ The report adds that this is ‘‘driving disciplines toward each other’’ and

that ‘‘the next generation of scientists must be prepared to integrate the advances

of rapidly progressing disciplines.’’ The report nicely complements the changes in

the nature of research that I highlighted above.

Meeting the future needs of research in health and behavior means NIH must

have a comprehensive training strategy today, a strategy that focuses on training

young investigators in the core disciplines of behavioral and social science research

as well as in the multidisciplinary perspectives alluded to in the NRC report and

elsewhere. In addition to encouraging behavioral science training at individual institutes, NIH needs an overall plan that will minimize unnecessary duplication and

will establish an appropriate behavioral science training enterprise that can serve

the needs that exist throughout NIH’s institutes and offices.

We ask the Committee to support the development, in consultation with the relevant scientific community, of a comprehensive training strategy for behavioral and

social science research at NIH. This strategy should include all training mechanisms, and should be balanced between interdisciplinary research and traditional

core disciplines in the behavioral sciences.

National Institute of Mental Health (NIMH).—Translational Research—In an effort to more closely link basic and clinical research in behavioral science, NIMH is

implementing an institute-wide plan to expand its ‘‘translational research’’ activities

that are intended to bring knowledge from the lab into practice, and for practice to
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influence what occurs in the laboratory. Responding to recommendations from a report conducted under the auspices of its national advisory council, NIMH is stimulating new connections between basic and clinical research through such mechanisms as: Requests for Application (RFAs); providing greater access to clinical populations and collaborators; workshops connecting basic researchers with public health

and clinical investigators; and new peer review procedures that draw on experts

from both clinical and basic perspectives. NIMH is also considering support for

translational research centers in behavioral science.

Basic Behavioral Research.—We applaud NIMH for its efforts to promote the

transfer of knowledge into application. But basic behavioral research at NIMH must

continue to receive the same strong support it traditionally receives there. This is

important not only to ensure the foundation of basic knowledge in mental health,

but also because NIMH is a de facto source of basic behavioral knowledge that is

tapped by many other institutes. Until other institutes begin to support larger

amounts of basic behavioral science research connected to their mission, it is essential that NIMH’s programs of research into behavioral phenomena such as cognition,

emotion, psychopathology, perception, development, and others continues to flourish.

We ask the Committee to encourage NIMH’s continued efforts to strengthen the

ties between basic and clinical behavioral research, and to encourage NIMH’s basic

behavioral science portfolio in order to ensure continued progress in our understanding of the causes, treatment, and prevention of mental illness and the promotion of mental health.

National Institute on Drug Abuse (NIDA).—NIDA’s dramatic progress in addressing the Nation’s drug problems (many of which are behavioral in nature) has been

accompanied by a broadening of its behavioral science portfolio. Under the leadership of psychologist Alan I. Leshner, NIDA has launched a widescale Clinical Trials

Network (CTN) to test drug treatment strategies that have proven effective under

controlled research conditions. Most of the interventions currently being tested are

based on behavioral treatments, since those have been found to be effective. The

CTN was recommended by the 1998 Institute of Medicine report, Bridging the Gap

Between Research and Practice, as the single mechanism most likely to improve

drug abuse treatment in this country. Given the enormous promise of this initiative

to improve the Nation’s drug treatment programs and the urgency of the Nation’s

public health problems associated with drug abuse and addiction, we ask the Committee to increase funds for NIDA’s Clinical Trials Network in fiscal year 2002.

In addition to the Clinical Trials Network, NIDA’s basic behavioral research helps

treatment providers better understand and address the dynamics of addiction. NIDA

is placing special emphasis on cognitive research because processes such as learning, memory, decision-making, and other cognitive factors play a central role in virtually every aspect of drug abuse and addiction, including vulnerability, craving, relapse, self-regulation, and treatment. The knowledge from NIDA’s basic behavioral

science research has enormous potential for reducing demand for drugs at the individual, family and community levels. We ask this Committee to increase NIDA’s

budget as part of an overall policy of creating a more balanced and effective drug

control strategy for the Nation.

National Institute on Alcohol Abuse and Alcoholism (NIAAA).—College-age drinking and underage drinking are two behavioral topics of enormous concern to the Nation’s universities, parents, and communities. A subcommittee of the NIAAA national advisory council is completing a report addressing various aspects of campus

drinking. The report, being developed jointly by alcohol researchers and college

presidents, describes the scope of the problem, examines the effectiveness of current

interventions, and will recommend priorities for developing effective, science-based

interventions to reduce college drinking.

NIAAA has made substantial efforts to broaden its behavioral science portfolio to

understand the underlying psychological and cognitive processes that lead people to

drink, and the impact of chronic alcohol abuse on those processes. As one example,

NIAAA convened a workshop of national experts on social identification and alcohol

research to examine ways that peer pressure in groups and group norms concerning

drinking may influence drinking behaviors. More recently, the institute convened a

group of experts in cognitive research to explore the effects of alcohol abuse on memory, decision-making, cognitive development, in order to begin looking at issues of

cognitive rehabilitation.

Understanding the behavioral origins and manifestations of problem drinking and

addiction is the key to addressing the Nation’s epidemic of alcohol-related behavioral health problems, which range from brain disease to drunk driving. We ask

Congress to increase NIAAA’s budget in fiscal year 2002 in order to reduce the Nation’s alcohol-related health problems.
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National Institute of General Medical Sciences (NIGMS).—NIGMS is the only national institute specifically mandated to support research not targeted to specific

diseases or disorders. NIGMS does not now support basic behavioral science research, despite the wide range of fundamental behavioral topics with relevance to

a variety of diseases and health conditions. The lack of behavioral science research

at NIGMS represents is an enormous gap, given the basic behavioral research and

training that NIGMS should be supporting. Congress addressed this issue for the

past two years in appropriations reports on the fiscal year 2000 and fiscal year 2001

budgets for NIH. Specifically, you said: ‘‘There is a range of basic behavioral research and training that the Institute could support, such as the fundamental relationships between the brain and behavior, basic cognitive processes such as motivation, learning and information processing, and the connections between mental processes and health. The Committee encourages NIGMS to support basic behavioral research and training, and to consult with the behavioral science research community

and other Institutes to identify priority research and training areas.’’ NIGMS has

not responded to your requests. We continue to believe strongly that NIGMS should

develop a basic behavioral science research program. Accordingly, we ask the Committee to direct NIGMS to develop a plan for basic behavioral science research at

NIGMS.

National Cancer Institute (NCI).—NCI has expanded its commitment to behavioral research in a comprehensive program that ranges from basic behavioral science

to research on the development, testing and dissemination of disease prevention and

health promotion interventions in areas such as tobacco use, diet, and even sun protection. Recognizing the central role of effective communication in addressing issues

of health and behavior, NCI has also undertaken a major effort to develop sciencebased communications strategies for disseminating information and persuasive messages about cancer prevention and treatment to the public. These messages draw

from a foundation of basic behavioral and social science research into such issues

as how people learn and remember health information, how they perceive health

risks, and how they are persuaded to adopt healthy behaviors.

One of NCI’s scientific priorities in fiscal year 2002 is tobacco-related research.

A significant portion of this initiative is devoted to behavioral and social science research into such topics as identifying populations at risk for tobacco use, formulating effective prevention and quitting strategies, and capitalizing on legal, social

and public policy developments on tobacco use and addiction.

Other basic behavioral research programs include research to develop theoretical

models, identify underlying mechanisms of behavior change, and to develop and test

science-based interventions. For example, NCI supports research that examines how

stress and psychosocial influences on behavior, the central nervous system, the immune system, and CNS-immune system interactions affect the progression and remission of cancer. Other examples include research into the psychophysiological and

genetic processes involved in health behaviors, and the psychosocial and behavioral

consequences of cancer risk assessment, including the impact of genetic testing on

the individual and the family.

NCI’s behavioral research program also supports health promotion research, including behavioral science relating to cancer prevention and program evaluation. We

ask Congress to support NCI’s expanded behavioral science research and training

initiatives.

National Institute on Aging (NIA).—NIA is a major supporter of behavioral and

social science research. NIA has reorganized its behavioral and social science programs in order to respond to—and create—new opportunities in the study of aging

processes, how older people function in society, and how people change with aging.

NIA also looks at the social institutions such as family and the health care system

in terms of their impact on the health of older people. Areas of emphasis in NIA’s

behavioral and social science programs include health disparities, aging minds,

health expectancy, health, work and retirement, behavior change, and the interplay

among genetics, behavior, and social environment. NIA also supports a significant

amount of research in cognitive functioning in its neuroscience and neuropsychology

program, which looks at the effects of aging on memory and other brain-based behavioral functioning. We ask the Committee to support NIA’s commitment to behavioral and social science research on aging.

National Institute on Child Health and Human Development.—Child development

involves some of the most complex and important questions facing behavioral and

social science researchers. Understanding the interplay among behavior, social and

physical environment, and biology is central to discovering ways to prevent behavior-based health problems ranging from fetal alcohol syndrome to teen pregnancy to

violence. NICHD’s Child Development and Behavior Branch supports research on

the cognitive, social, and emotional development of children from newborns to ado-
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lescents. We are concerned that NICHD has received a below-average share of

NIH’s budget increases in the past few years; what this conveys, whether intended

or not, is that children’s issues have lower priority in health research. We hope you

will send a strong counter-message this year, and allow NICHD to enhance its child

development portfolio. We ask the Committee to allocate the necessary resources in

fiscal year 2002 to allow NICHD to fulfill its mission in these areas.

On a related topic, NICHD has been supporting the Study of Early Child Care

and Youth Development, the most comprehensive study to date of child care experiences and characteristics and developmental outcomes. NICHD is now sharing the

rich body of data from the study with other qualified researchers in order to allow

an even greater number of researchers to explore issues around child care, including

those that may affect child development. We ask the Committee to support this

study and NICHD’s data-sharing initiative.

NIH Office of Behavioral and Social Sciences Research (OBSSR).—We ask the

Committee to welcome Raynard Kington as the new director of OBSSR, and to encourage him, as he contributes his expertise to NIH’s ‘‘Health Disparities’’ initiative,

to ensure that the full spectrum of behavioral and social science research be brought

to bear on this important topic as well as on the other initiatives that are within

OBSSR’s purview.

Communication Disorders, Visual Perception, Diabetes, Brain and Behavior.—Although space doesn’t permit me to describe fully some of the other behavioral

science activities across NIH, I want to note the impressive behavioral science work

being done in such areas as communication disorders, visual perception, diabetes,

and brain research, all of which merits the encouragement and support of this Committee. We ask that in fiscal year 2002, support be given to expanding the behavioral science research and training programs at institutes where this important

work is being done.

This concludes my testimony—I would be pleased to answer your questions or provide additional information.

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY

The American Society of Clinical Oncology (ASCO) represents more than 16,000

physicians involved in cancer research and treatment. ASCO is the leading voice

among medical professional societies concerning issues of cancer clinical research.

The Society is pleased to have the opportunity to comment on fiscal year 2002 appropriations for the National Institutes of Health (NIH) and the National Cancer

Institute (NCI), as well as other issues related to the missions of NIH and NCI.

These matters are of great importance to clinical researchers, physicians, and their

patients.

FISCAL YEAR 2002 APPROPRIATIONS FOR NIH AND NCI

ASCO applauds the commitment of this Subcommittee and the outstanding leadership of Chairman Arlen Specter and Ranking Member Tom Harkin to doubling

the budget for NIH between 1999 and 2003. This panel’s commitment has been essential to ensuring predictability and stability in NIH funding and allowing scientists to pursue exciting new research endeavors. We believe the biomedical research effort of this country is so strong largely because of the unwavering support

of Congress.

As you know, sustaining progress toward the goal of doubling the NIH budget by

2003 requires a funding boost of 16.5 percent in 2002. We greatly appreciate the

budget amendment sponsored by the Chairman and Ranking Member to achieve

this effort. We strongly support a 16.5 percent increase for NIH and will work with

you toward that goal.

In addition, we recommend that funding for NCI be enhanced in accordance with

the Institute’s plan and budget proposal for fiscal year 2002 ( the ‘‘Bypass Budget’’).

As directed by Congress in the National Cancer Act of 1971, each year the NCI delivers a ‘‘bypass’’ budget directly to the President. This process was implemented to

ensure that the President and Congress directly receive NCI’s scientific recommendations on the best way to appropriate funds to build on research successes,

support the cancer research workforce, and ensure that recent discoveries are translated into improved patient care. For fiscal year 2002, the NCI recommends funding

of $5.03 billion, an increase of $1.27 billion. Funding NCI at this level will allow

the Institute to fund promising and innovative investigator-initiated research proposals and facilitate research that capitalizes on important advances in molecular

biology. ASCO believes the bypass budget includes a persuasive rationale for boost-
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ing the NCI budget to $5.03 billion, and we urge the Subcommittee to begin the new

millennium by implementing this carefully considered budget proposal.

FUNDING FOR CLINICAL TRIALS OPERATION

If promising basic research advances are to have meaning for Americans, they

must be translated into medical practice. This translation process can only be accomplished through clinical research. NCI provides essential support for cancer clinical research. NCI-sponsored trials represent at least half of all cancer trials. Unfortunately, NCI does not provide adequate funding to support the grants they award.

ASCO funded three surveys in September 1998 to examine (1) oncologists’ experiences and perceptions associated with clinical trial participation; (2) pharmaceutical

industry participation in clinical trials; and (3) the costs associated with conducting

clinical trials. The surveys indicated that physicians prefer to participate in NCI

trials, especially those conducted through the cooperative cancer groups. They report

that these trials are exceptionally well designed, respond to the critical goals of oncology, and are intellectually challenging. Participating in these trials, however,

amounts to an act of good will, since physicians lose money on every NCI trial they

conduct.

Conducting a clinical trial requires tremendous resources for a physician practice.

These resources include trained research nurses and data managers and the computer equipment needed to compile and analyze the data. In fact, it takes 15 separate activities to enroll patients and conduct a clinical trial. The most time-consuming of these activities include recruiting patients, seeing patients in the physician’s office, and completing forms. Overall, 200 hours of work are required to see

one patient through the clinical trial process. Our 1998 survey found that the average cost to enroll a patient in a clinical trial is $2,000 per patient. Current NCI reimbursement is $1,500 per patient.

Our ability to find better cancer treatments and improved understanding of this

dreadful disease are inextricably linked to a thriving clinical research network.

Without proper reimbursement, physicians will be pressed to devote less time to

clinical research—especially with the pressure that managed care is placing on practices to seek higher reimbursements. If trials are adequately funded and supported,

we could shorten the length of time it takes to complete patient accrual—thus quickening the time it takes to complete research and improve patient care. We will not

reap the full rewards of our increased investment in NIH and NCI unless we provide adequate support to the physicians who are conducting clinical trials.

CLINICAL RESEARCH STUDY SECTION

Investigator-initiated clinical research proposals have not fared well historically

at NIH because they have been reviewed by basic researchers who are not well

versed in patient-oriented research. ASCO has maintained that allowing the proportion of reviewers for such patient-oriented research proposals to be dominated by

basic researchers is inequitable, a position endorsed by several blue ribbon panels

charged with oversight of the NIH peer review process. Furthermore, physician scientists’ success in obtaining NIH funding for investigator-initiated research has a

significant impact on their willingness to remain in the field, according to reports.

Therefore, the research review process has a significant impact on today’s clinical

research and on the future of patient care.

ASCO has previously brought the issue of peer review of cancer clinical research

to the attention of this Subcommittee, and the panel has supported efforts to improve the grants evaluation process. As a result of Subcommittee directives to the

NIH, the Center for Scientific Review (CSR) appointed a special emphasis panel

(SEP) to review clinical oncology research proposals. The Clinical Oncology (CONC)

SEP is composed of clinical researchers who have the expertise and experience to

evaluate cancer clinical research proposals. We are pleased that a number of clinical

oncologists sit on the CONC SEP, and reports on its work have been positive. We

are also pleased that CSR is currently in the process of making the CONC SEP into

a permanent study section. We believe this will result in a system of fair and informed review of clinical oncology research.

Through this transition and the larger CSR transformation of the Integrative Review Group (IRG) system, we remain chiefly concerned that clinical oncology research proposals are reviewed by committee members with expertise in patient-oriented research. External NIH advisors have consistently recommended that NIH

avoid a review process where basic researchers dominate the review of patient-oriented research proposals. A majority of the membership of panels reviewing clinical

research should have experience in reviewing and/or conducting patient-oriented research. ASCO urges the Subcommittee to renew its directive to NIH officials to
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maintain a peer review system that has researchers with patient-oriented research

expertise making up the majority of researchers reviewing cancer clinical research

proposals. The Subcommittee’s involvement will be particularly timely, as CSR is

currently in the process of appointing steering committees and study teams to begin

work on organizing the Oncological Sciences IRG in the coming months. ASCO believes that a rigorous peer review system is fundamental to a strong clinical research effort.

CLINICAL TRIALS COVERAGE

ASCO has worked for several years for enactment of the Medicare Cancer Clinical

Trials Coverage Act, which would require Medicare to reimburse the routine patient

care costs for those enrolled in cancer clinical trials. We are pleased that President

Clinton responded to our decade-long legislative effort by issuing an Executive

Memorandum last year that provides Medicare coverage of the routine patient care

costs of those enrolled in trials. The new Medicare policy lays the groundwork for

increasing seniors’ participation in clinical trials—thereby improving their access to

state-of-the-art care and speeding the translation of research discoveries into effective patient treatments.

We are continuing our work to ensure that enrollees of private-sector health plans

have access to this same quality cancer care. We have been actively involved in efforts to ensure clinical trials coverage provisions in the Patients’ Bill of Rights. Although coverage for routine patient care costs is not technically a matter for this

Subcommittee, assurance of such coverage is critical to the efficiency of the research

enterprise and is therefore surely a concern for this panel. Only if treatments can

be tested in clinical trials can clinical researchers determine their effectiveness. If

reimbursement denials or the fear of such denials slow accrual to clinical trials, this

will adversely affect the ability of researchers to answer questions about new treatments. ASCO believes it is absolutely necessary that barriers to enrollment in clinical trials, including possible reimbursement uncertainties or denials, be eliminated.

ASCO appreciates the opportunity to submit its views on NIH funding and clinical

research. On behalf of oncologists and their patients, we urge Congress to continue

its strong support of NIH. We also recommend that special attention be paid to the

clinical research enterprise to ensure that basic research findings are promptly

brought to the patient bedside.

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF CLINICAL PATHOLOGISTS

The United States is approaching a serious shortage of medical laboratory personnel. The vacancy rates for seven of ten key laboratory medicine positions is at

an all time high.

Vacancy rates for cytotechnologists, the professionals who interpret cellular material such as Pap smears, and histotechnologists, the individuals who prepare tissue

specimens, are at a disturbing high of over 20 percent. This is a cause for immediate

concern as some laboratories will not have the appropriate personnel available to

evaluate Pap smears or prepare biopsies.

The American Society of Clinical Pathologists’ Board of Registry, in conjunction

with MORPACE International, Inc., Detroit, conducts a biennial wage and vacancy

survey of 2,500 medical laboratory managers. The survey measures the vacancy

rates for 10 medical laboratory positions, and compares and contrasts these data

with that from 1988, 1990, 1992, 1994, 1996, and 1998 studies. The data for 2000

was published in March 2001, and this statement gives a glimpse of what was

found.

Vacancy rates for cytotechnologists in the northeast average 45 percent, 16.7 percent for the east north central, and 33.3 percent for the far west. Rural areas average a 20 percent vacancy rate for cytotechnologists, and large cities a rather surprising 28.3 percent rate.

Private reference laboratories have an average vacancy rate of 20 percent for

histotechnologists, and hospitals have a 37.7 percent shortage of the same profession. The west south central region of the country has a 73.7 percent vacancy rate

for histotechnologists, and the south central Atlantic states have an average vacancy

rate of 16.7 percent.

By comparison, the vacancy rate for medical technologists will not appear to be

of concern, but it too is reason for concern. Medical technologist vacancy rate averages 11.1 percent, but rural areas show 21.1 percent vacancy and hospitals with

100–299 beds have a rate of 17.6 percent.
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MEDICAL LABORATORY PROGRAMS

One of the logical solutions to this vacancy rate problem is to train more students;

however, the number of programs are decreasing.

According to the ‘‘Health Professions Education Directory’’ published by the American Medical Association, the number of medical technology programs decreased

from 383 in 1994 to 273 in 1999. The number of graduates in medical technology

has similarly decreased from 3563 in 1994 to 2491 in 1999, a 30 percent decline in

five years.

ASSESSMENT

There are several reasons why the vacancy rate is increasing and the number of

program enrollees is decreasing. A number of available positions are outside the traditional clinical laboratory. Some program directors have reported that graduates

are gaining employment in laboratory information systems companies, ‘‘dot.coms,’’

and corporations that manufacture or distribute diagnostic reagents, supplies or

equipment. With limited resources, hospitals have merged, thus decreasing the

availability of training sites for medical laboratory programs. Some programs have

responded by increasing access to other laboratory training sites, such as forensics

laboratories, blood centers, physician offices, and outpatient clinics. Yet, with these

shifts, the continued demand for laboratory services is real and is expected to grow.

In Pennsylvania, according to the Bureau of the Census, the population is projected to grow by 3 percent by 2020, and the population over age 65 is projected

to grow by 24 percent in the same time period. In Iowa, the population is projected

to grow by 4 percent by 2020, and the population over age 65 is projected to grow

by 37 percent in the same time period.

Given the country’s aging population, the number and complexity of biopsy specimens and the use of molecular techniques will likely increase during the next decade. Laboratory professionals who entered the workforce in the 1960s and 1970s will

be retiring soon. Also, the threat of bioterrorism calls for trained laboratory professionals to respond. The laboratory-allied health workforce will need to be able to

react accordingly with appropriate numbers of trained and educated personnel.

SOLUTIONS

There are solutions to these problems. There are grants available to help attract

laboratory professionals to the field, especially minorities and individuals in rural

and underserved communities. The Allied Health Project Grants program, administered by the Health Resources and Services Administration, has been successful in

effectively attracting new allied health professionals into the laboratory field.

For example, the University of Nebraska Medical Center established medical technology education sites in four communities in rural Nebraska, including a student

laboratory in central Nebraska, under an Allied Health Project Grant. As of 1999,

of 69 graduates, 99 percent took their first job in a rural community, and 74 percent

took their first job in rural Nebraska.

The grants are also designed to create successful minority recruiting and retention programs for medical technologists. This was the focus of a University of Maryland, Baltimore project initiated by allied health grant funding in 1991. Through

utilizing a four phase design, which begins with career awareness activities for elementary and middle school students, this model provides a continuum of activities

that progressively focuses on identifying, retaining, and advancing interested students to the completion of a baccalaureate degree. Because of this program, the University of Maryland, Baltimore has attained a current 70 percent minority medical

technology student enrollment at a majority institution, and an average 89 percent

student retention rate, placing it among the highest in the country. 95 percent of

the graduates of this program receive immediate placement.

Most allied health grant projects continue after federal funding ends, making

them a long-lasting, worthwhile investment in the future of allied health.

While allied health professionals comprise more than 60 percent of the entire

health care work force, and number more than 3 million individuals, the attention

paid to these health professionals is rather small. Allied health professionals are involved in the prevention, identification, monitoring, and evaluation of diseases, disabilities and disorders. The Allied Health Project Grants program is a relatively

small step in assuring that funding is available to attract allied health professionals

to the professions and to underserved communities, but, given the critical shortages

mentioned, it needs to be taken quite seriously.

We respectfully request funding for the Allied Health Project Grants in the

amount of $21 million.
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The American Society of Clinical Pathologists (ASCP) is a nonprofit medical specialty society organized for educational and scientific purposes. Its 75,000 members

include board certified pathologists, other physicians, clinical scientists, and certified technologists and technicians. These professionals recognize the Society as the

principal source of continuing education in pathology and as the leading organization for the certification of laboratory personnel. ASCP’s certifying board registers

more than 150,000 laboratory professionals annually.

Thank you for this opportunity to submit written testimony for inclusion in the

hearing record.

PREPARED STATEMENT OF THE AMERICAN SOCIETY FOR MICROBIOLOGY

The American Society for Microbiology (ASM) gratefully acknowledges Congress’

increased support for the Centers for Disease Control and Prevention (CDC), particularly for the CDC’s National Center for Infectious Diseases (NCID), which supports programs to address emerging and drug resistant infectious diseases, public

health infrastructure, bioterrorism preparedness and food safety. The CDC is the

primary agency responsible for guarding the public’s health, including protecting the

nation against potentially life threatening infectious diseases. The ASM appreciates

Congressional recognition for CDC’s role in responding to the threats of emerging

infectious diseases and encourages Congress to maintain and renew that support.

The ASM endorses the recommendation of the CDC Coalition to increase the overall CDC budget to $5 billion in fiscal year 2002 to provide additional new resources

for CDC programs focused on national and global health and security. The CDC is

called upon constantly to identify, control, and prevent outbreaks of disease here

and abroad. For the past fifty years, members of the CDC’s Epidemic Intelligence

Service have helped solve microbial mysteries, such as the recent outbreaks of Legionnaire’s disease at a Cleveland automotive plant and the unexpected arrival in

New York of West Nile encephalitis. Despite this nation’s successes against certain

diseases, our public health system continues to be at risk from both new and reemerging infectious diseases, from threats of bioterrorism and antibiotic resistant

pathogens, and from an aging public health infrastructure. These areas are of particular concern to the ASM, which represents more than 42,000 members from a

broad spectrum of microbiology-related professions, including microbiologists who

work in biomedical, clinical, public health, and industrial laboratories.

Prevention strategies promoted by the CDC promise significant rewards in the

form of improved public health. Likewise, strong financial support for the CDC will

give Americans both a healthier society and cost-saving benefits. The multi-billiondollar cost of microbial diseases in this country alarms all of us. Foodborne diseases

alone cost the national health care system more than $3 billion per year, added to

annual lost productivity estimated at $8 billion. On a global scale, the CDC’s participation in eradication campaigns like that against polio also promises high returns:

the United States would save more than $230 million annually in vaccine costs, and

worldwide the estimated savings would exceed $1.5 billion. Investment in a stronger

CDC undoubtedly will yield measurable positive results in the form of disease identification and control, helping to fulfill the CDC’s vision of a healthier 21st Century.

Investment in CDC will also enhance national and global security, both economic

and political. For these reasons, the ASM asks Congress to respond aggressively to

threats from infectious diseases with generous support of the Centers for Disease

Control and Prevention.

INFECTIOUS DISEASES—THREATS TO NATIONAL AND GLOBAL HEALTH AND SECURITY

Microbial pathogens and the diseases they cause persist as a leading cause of

death worldwide and in the United States. In today’s global society, it is possible

for a new disease to spread internationally within days, perhaps hours. It is alarming to realize that infectious diseases would cause even more deaths in this country

if it were not for a persistent federal assault against these pathogens.

The CDC’s vision for the 21st Century is ‘‘healthy people in a healthy world—

through prevention.’’ Toward this goal, the CDC launched a nationwide effort to protect the public from infectious diseases that includes surveillance and response, applied research, infrastructure and training, and prevention and control. In 1998 the

CDC developed a comprehensive plan, ‘‘Preventing Infectious Diseases: A Strategy

for the 21st Century,’’ listing a sobering array of new and re-emerging infectious diseases and the obstacles that make stopping these diseases so difficult. Last year,

Congress passed the Public Health Threats and Emergencies Act to strengthen the

public health infrastructure in the areas of antimicrobial resistance, bioterrorism

and major infectious disease outbreaks.
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New and re-emerging infectious diseases pose unique challenges to the CDC in

its role as the nation’s prevention agency. More than 35 new infectious diseases

have been identified since 1973, among them those caused by HIV, E. coli O157:H7,

and airborne Ebola virus. The ever-changing threats posed by infectious diseases

demonstrate the importance of a public health infrastructure capable of rapid and

accurate disease identification and prevention anywhere in the United States or

abroad. On-call CDC personnel consistently assist local and state health departments across the United States in identifying outbreaks due to such emergent

microorganisms as the West Nile virus.

First described in New York State in 1999, West Nile encephalitis spread to a

wider area during the summer of 2000, carried by mosquitoes and underscoring the

need to rebuild our capability to deal with vector-borne diseases. The CDC’s response illustrates its four-pronged approach—surveillance and response; applied research; infrastructure and training; and prevention and control—to protect the public against infectious diseases. The agency developed a national electronic surveillance system (ArboNet) to track the virus in humans, birds, mosquitoes and horses.

It also helped develop rapid laboratory tests to detect the presence of the virus, as

well as a DNA vaccine that thus far looks promising in animal studies. Funding to

49 state and local health departments and related training sessions and educational

materials enhanced the public health system’s chance of stopping the virus. To prevent spread of the virus, the CDC formulated a large-scale emergency plan for mosquito control in affected areas.

A similar multifaceted CDC program is in place against hepatitis C viral infection

(HCV), a relatively recent problem in the United States. HCV is the most common

chronic bloodborne viral infection in the United States, where it has infected more

than 4 million people, nearly 75 percent of whom remain chronically infected. Persistent infection often leads to serious medical conditions, possibly cirrhosis or liver

cancer; in fact, an estimated 40 to 60 percent of chronic liver disease is due to this

virus. The CDC supports a national survey of blood collection centers and hospital

transfusion services to determine the progress of notifying transfusion recipients

who received blood from donors who later tested positive for HCV, works with state

and local health departments to coordinate activities including viral hepatitis education and counseling, testing, referral, surveillance and vaccination efforts, and coordinates the Hepatitis C Public Information Campaign. CDC will continue to fund

new studies to monitor the transmission of HCV among various populations, enhance support for state and local health department programs, and develop and provide training to healthcare professionals.

New infectious diseases are not the only menace to public health. Historic killers

such as malaria and influenza continue to challenge national and global health systems. Of all the emerging and re-emerging infections, influenza has the greatest potential to cause catastrophic morbidity, mortality, and social disruption both locally

and globally. Three pandemics in the past century were grim reminders of how dangerous influenza can be. The CDC actively supports influenza surveillance in other

countries, to monitor for variant viruses that may cause new pandemics. Agency

mathematical models suggest that an influenza pandemic could result in a five-fold

increase in U.S. deaths, compared with non-pandemic years. In a typical year, the

disease causes an average of 20,000 deaths in the United States, along with more

than 110,000 hospitalizations. Each year brings new influenza viruses and fears of

even more serious U.S. epidemics, during which up to 40,000 deaths and 200,000

hospitalizations can occur. The CDC counters such persistent problems with longterm, year-round surveillance both in the United States and in countries known to

be sources of new viruses. As with other diseases, the agency also works to improve

individual states’ ability to respond to epidemics and to strengthen the international

network of laboratories and personnel able to identify outbreaks. Recognized as a

global leader in responding to any disease outbreak, the CDC must be provided with

sufficient resources to improve its readiness for any future pandemic.

Antibiotic resistance in pathogens and the threat of bioterrorism have further

complicated the current global infectious disease crisis, forcing health officials to

rethink our approach to both old and new infectious disease. Overuse of antibiotics

contributes to a rising incidence of microbial mutants resistant to the traditional

therapeutic-of-choice. In some areas of the United States, more than 30 percent of

pneumococci resist penicillin, a drug once effective against virtually all pneumococcal pneumonia and meningitis. More than 90 percent of strains of Staphylococcus

aureus in U.S. hospitals are resistant to penicillin; these strains now are spreading

into the general community. Other common infections, such as gonorrhea and salmonella, also are becoming more difficult to treat. The cost of resistant diseases is

significant: the U.S. health care system spends an estimated $1.3 billion, annually,

on the treatment of nosocomial infections caused by resistant organisms. It normally
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costs $2,000 to treat a patient for tuberculosis in this country, but if the tubercle

strain is resistant, that cost may be inflated 100 times.

On January 18, the Department of Health and Human Services released its plan

to combat antimicrobial resistance, to be led by the CDC, the Food and Drug Administration (FDA) and the National Institutes of Health. The plan, which provides a

blueprint for coordinated federal action, has four components—surveillance, prevention and control, research, and product development. CDC personnel and collaborators will work with state health departments and others to coordinate and improve surveillance methodologies. The CDC already has begun preparation of clinical guidelines for health professionals on the best use of antimicrobials and on infection control practices, to prevent the spread of drug resistance. With the FDA and

the U.S. Department of Agriculture, the CDC is monitoring resistant nosocomial infections in 300 hospitals in 15 states. This program complements the CDC’s National Nosocomial Infection Surveillance System (NNISS) already in place, a prototype system for preventing adverse health care events. An estimated 44,000 to

98,000 Americans die each year from preventable medical errors, which include

nosocomial infection. In the past decade, hospitals participating in the NNISS have

had a 30 percent decline in targeted infections.

Substantial funding and flexibility is needed to enable CDC to fully implement

the goals set forth in its strategic and comprehensive plan against emerging and reemerging infectious diseases. The ASM recommends an additional $120 million in

fiscal year 2002 to achieve such goals as improving the detection and prevention of

emerging pathogens, communicating among all levels of government health agencies, and integrating laboratory science with on-site epidemiology.

BIOTERRORISM PREPAREDNESS AND RESPONSE

Unfortunately, emerging infectious diseases and drug-resistant pathogens could

also be used in terrorist attacks. The CDC considers bioterrorism as part of its mission against emerging infectious diseases here and abroad. It is worrisome that

there is no guarantee that the nation’s current public health infrastructure could

adequately respond to a bioterrorist event. CDC has joined other federal agencies

in implementing new programs and expanding others to include counterterrorism

capabilities.

To diminish our vulnerability to such attacks, the CDC will continue to focus its

attention on laboratory capabilities at CDC and at State and local health department levels; on the development and implementation of rapid diagnostic tests for

biological agents; on surveillance activities with hospitals, health clinics, private and

commercial laboratories, as well as with veterinary and agriculture partners; on

electronic communication capacity at the local level with the Health Alert Network

(HAN) and the National Electronic Data Surveillance System (NEDSS), designed to

collect, analyze and interpret health-related data in a timely and efficient manner;

and on public health preparedness and readiness activities such as the education

and training of both public and private health care personnel, firefighters, police officers and emergency medical technicians.

In fiscal year 2002, ASM recommends that Congress provide an additional $100

million for CDC to continue and expand these activities to respond to the threat of

bioterrorism.

BUILDINGS AND FACILITIES

In protecting American health and safety, the CDC puts science into action,

shares vital information, and creates partnerships with public and private groups

concerned with public health. But unless the CDC’s buildings and physical infrastructure receive more funding from Congress, its ability to respond to disease anywhere, anytime, could be seriously undermined. The expansion of CDC’s responsibilities around the world and in the United States has stretched thin the agency’s infrastructure. CDC buildings in Atlanta cannot house the current staff and about

half of that workforce labors in nearly two dozen leased offices around Atlanta.

Much of CDC’s laboratory equipment is outdated. According to the agency, at

present 70 percent of its infectious disease scientists and all of its parasitology and

environmental health specialists work in highly inadequate and potentially hazardous laboratories. Last year the CDC began a phased 10-year improvement of its

Atlanta facilities. As a result, phase I of the infectious disease laboratory was completed and opened, and phase II will be completed this fall. In addition, the emerging infectious disease laboratory is currently being designed and construction has

begun on parasitology and environmental health laboratories. The ASM appreciates

Congress’ attention to CDC’s physical infrastructure needs and urges an additional

$175 million in fiscal year 2002, for the construction of the emerging infectious dis-
501

ease laboratory, the design for the environmental toxicology laboratory and routine

maintenance projects nationwide.

Thank you for the opportunity to submit ASM’s recommendations for the hearing

record of the House Appropriations Subcommittee on Labor, Health and Human

Services, and Education, for the CDC’s fiscal year 2002 appropriation.

PREPARED STATEMENT OF THE AMERICAN SOCIETY FOR MICROBIOLOGY

The American Society for Microbiology (ASM) appreciates the continued bipartisan support of Congress for the National Institutes of Health (NIH). Through generous appropriations over the past years, Congress has brought biomedical research

to the forefront of the national agenda and recognized the NIH’s pivotal position in

serving the American public through the support of biomedical research. Increased

support for NIH not only helps to ensure the continued leadership of the United

States in biomedical research, but it will also allow the United States to address

the global health issues in infectious diseases that currently threaten national security. The ASM commends President Bush’s proposal for a record $2.8 billion increase

for the NIH in fiscal year 2002. This proposed increase is a major step toward meeting the bipartisan goal set by Congress of doubling the NIH budget by fiscal year

2003, enabling the Institutes to take greater advantage of the many recent significant discoveries affecting human health.

Within the past few years we have seen exponential advances in knowledge in the

biomedical sciences. The landmark advances of decoding the human genome and sequencing over 30 bacterial genomes, discovering new treatments for AIDS, and developing vaccines that can prevent meningitis and ear infections in children are only

a few of the many accomplishments that have set the stage for an even more explosive growth in the benefits derived from NIH research.

The opportunities for substantial return on investment in biomedical research

have never been greater, and it is essential that the NIH be supported at a level

to take full advantage of promising existing and new areas of basic and clinical research. According to a report of the Joint Economic Committee, public investment

in NIH yields returns to the economy of 25 percent to 40 percent per year. The development of the Hemophilus influenzae vaccine to prevent meningitis in children,

for example, has saved an estimated $400 million yearly in treatment and long-term

care costs.

At the same time, we are being challenged by emerging and existing infectious

diseases, increasing resistance to antibiotics, and accumulating evidence pointing to

an infectious cause for many chronic diseases, such as arthritis, heart disease, and

some forms of cancer. In addition, each year the cost of illness in the United States

totals an estimated $3 trillion in health care and lost productivity, representing 31

percent of the gross domestic product. The entire NIH budget equals less than 1

percent of this annual health-related burden on the national economy.

The ASM, therefore, joins with the Ad Hoc Group for Medical Research in endorsing an fiscal year 2002 budget increase of $3.4 billion (16.5 percent) for NIH to ensure we reach the goal of doubling the NIH budget by fiscal year 2003. Such an

increase will also enable the NIH to increase the total number of research project

grants it supports, thereby pursuing a greater number of scientific opportunities,

and to expand training programs, ensuring an adequate scientific workforce that

can translate research discoveries into significant patient care advances.

PUBLIC HEALTH NEEDS AND INFECTIOUS DISEASES

Past investments in medical research clearly have benefited both the United

States and the world in terms of improved health care and increased understanding

of disease. However, the ASM is concerned about the continuing onslaught of infectious diseases, a threat directly confronted by NIH-sponsored research. In the

United States, infectious diseases remain a leading cause of death, with five of the

top ten killers related to infection (pneumonia, AIDS, chronic liver disease, chronic

obstructive lung disease and cancer). The estimated annual cost of infectious disease

in this country exceeds $120 billion. Worldwide, infections account for more than 13

million deaths each year, potentially undermining both the political and the economic security of nations. Seven of the 20 leading causes of global death and disability are infectious diseases.

We can expect previously unknown infectious diseases—as well as old diseases

with renewed virulence—to continue to imperil public health. Microbial diseases

that appeared just in the last 25 years include legionnaires’ disease, HIV/AIDS,

Lyme disease, human cases linked to mad cow disease, airborne Ebola virus infec-
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tion, and toxic shock syndrome. Medical researchers have identified nearly 40 new

disease agents since 1973, some capable of massive destruction. In 1998, HIV/AIDS

was the fourth leading cause of death worldwide, responsible for an estimated 2.3

million deaths that year. In the United States, pathogens such as hantavirus from

rodents, the West Nile virus, and last year’s new hemorrhagic fever virus (the

Whitewater Arroyo virus) appeared during the past decade without warning, claiming human lives and placing new demands on our health care system. A recently

described hepatitis virus, type C, infects almost 4 million Americans. Although numbers of new infections have decreased due to better public health efforts, about 9,000

die from HCV each year and many more may develop chronic liver disease. HCV

is the leading cause of liver cancer and one of the major reasons for liver transplants.

In recent years there has been a resurgence of several long-time enemies of public

health, historic diseases revitalized by acquired antibiotic resistance and expedited

by global travel and commerce. Increasingly resistant to traditional therapeutics,

malaria continues to ravage the world’s populations, killing an estimated 1.1 million

each year and infecting 275 million new victims. In response to such alarming statistics, the NIH is leading a multilateral initiative against malaria, hoping to maximize research against the disease in Africa. Another long-time threat, tuberculosis

kills about 2 million people each year and persists as the eighth leading cause of

death worldwide, with fully one-third of the global population infected with the tubercle bacterium. Once treated effectively with drug regimens, bacteria causing tuberculosis are developing multiple drug resistance. Not just a problem in developing

countries, this more-virulent form of tuberculosis has now spread to several larger

American cities, a disturbing trend in a health care system where antibiotics have

become the second most commonly prescribed category of drugs.

Other pathogens, such as salmonella, Staphylococcus aureus, enterococci, and the

gonorrhea bacterium, are similarly acquiring drug resistance, becoming more serious problems in our nation’s hospitals. More than 90 percent of S. aureus found in

U.S. hospitals are now resistant to penicillin and beta-lactam antibiotics, for example. In intensive care units, nearly one-third of hospital-acquired nosocomial infections are resistant to the preferred antibiotic treatment. Nosocomial infections

caused by just six of the most common kinds of resistant bacteria cost the United

States at least $1.3 billion annually. In response, the NIH, CDC and FDA just released the Antimicrobial Resistance Action Plan, a comprehensive, multidisciplinary

collaboration with private and public groups to include surveillance, prevention and

control, research, and product development. NIH will lead the research component,

towards new information and technologies and support of clinical studies.

Among newly recognized infectious agents are those now believed linked to chronic disorders heretofore attributed solely to environmental or lifestyle factors, thus

further complicating our efforts to improve the public’s health. This new concept of

infectious diseases will force a reassessment of chronic disease—one example of how

NIH’s focus will change in a new era of medical research. Medical experts estimate

that infectious agents cause 16 to 20 percent of all cancers, and may be the underlying causes of common chronic diseases such as diabetes, multiple sclerosis, chronic

lung conditions, and coronary artery disease. Specific infectious agents already have

been indicted in certain conditions: for instance, Helicobacter pylori in peptic ulcers

and Borrelia burgdorferi in some forms of arthritis and brain disorders. With advances in genomics, it now is possible to identify non-human genetic material in

human diseased tissues, making this new field of medical research feasible. Investment of research dollars promises high returns, as suggested by estimates that more

than 50 percent of stomach and cervical cancers could be avoided by preventing

their suspected infectious disease etiologies.

Not only must the NIH focus on infectious diseases in this country, it also must

address the cumulative burden of disease worldwide. Infectious disease agents easily cross national boundaries, creating a global health interdependence that impacts

the health, economics and foreign policy of the United States. Infectious disease has

become a national security issue, as we become tightly connected to the rest of the

world physically, commercially and culturally. High incidence of mortality and disability can intensify social and political instability in countries where the U.S. has

significant economic and political investments. Infectious diseases also raise the possibility of bioterrorism through deliberate spread of dangerous microorganisms. The

NIH, through its research on diseases that primarily affect other countries—such

as malaria and cholera—accepts a responsibility towards fighting global infectious

disease. The ASM urges Congress to recognize the NIH’s role in national security

when determining the fiscal year 2002 budget.
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THE NEED FOR BASIC MICROBIOLOGY RESEARCH AND NIH FUNDING

Scientific knowledge of microbes and their link with larger life has expanded exponentially in the last half of the 20th century. Scientists studying microbes discovered that DNA was the genetic material of life. Many believe that the future of humankind depends on our ability to understand microbes and how they work and to

take advantage of their abilities to solve some of humanity’s most difficult problems,

including the prevention and treatment of infectious diseases.

The path of scientific investigation will shift in the coming decades, with new

funding needed for a broader scientific base that will require much more multidisciplinary research. Genomics is just one aspect of the increasingly complex research

enterprise needed to combat the diseases that afflict humankind. Conquering disease requires additional emphasis on environment and infectious disease. In particular the physiologies of organisms, that is the actual functioning of organisms

from microbes to humans, requires multidisciplinary inputs. Institutes like the National Institute of Environmental Health Sciences need to do more in areas such as

the environmental reservoirs and transport of pathogens so that we can understand

the epidemiology of many environmentally borne infectious diseases and act judiciously to prevent them. Studies on the interactions of genetics, environment, and

infectious diseases is critical for preventing and treating many human diseases.

Immediate attention is needed to reverse the decline in the field of microbial

physiology or we risk losing ground in medical and environmental research and discovery. The once flourishing field of basic (prokaryotic) microbiology is no longer receiving sufficient attention. The decline in funding devoted by the NIH to bacterial

physiology is compounded by the limited budgetary growth of other agencies, such

as the National Science Foundation, to support the basic cellular biological studies

of prokaryotes. Given that an understanding of bacterial physiology is a critical underpinning to overall cellular studies that are key to the advancement of the broader life and biomedical sciences, the NIH would be well served by coordinating with

other agencies to ensure the adequacy of funding for bacterial physiology. This

would be an important step for overcoming the shortage of qualified scientists with

training in bacterial physiology to fill the employment opportunities available in biotechnology and biomedical research laboratories The ASM recommends that NIH recommit itself to rebuilding support for this critical area and to take steps such as

training grants and requests for proposals to increase the number of laboratories,

institutions, and scientists working in this area.

The ASM emphasizes the importance of providing increased support for the basic,

untargeted research in the biomedical sciences supported by the National Institutes

of General Medical Sciences (NIGMS), which provides the fundamental underpinning for all the disease-oriented research done by other NIH Institutes. If we are

to sustain the momentum of NIH research in the future—and to build upon the notable advances made in recent years—it is important to recognize that basic and

clinical research both are indivisible segments of successful medical science. Basic

science is at the heart of what the NIH and research institutions do best. Basic research is the engine that drives scientific creativity and productivity making sustained funding for new research projects a particularly critical issue when deciding

the fiscal year 2002 budget. There must be a high-quality continuum of not only

new projects, but new scientist training programs, to keep American medical science

of the future as vigorous as it is today. We also need more physician-investigators

trained to translate discoveries into patient care and lives saved.

REQUIREMENTS FOR TODAY’S RESEARCH

Technological innovation may become the most visible hallmark of research in the

21st century, but it is just one aspect of an increasingly complex and expensive system needed to combat infectious diseases and other threats to national and global

health. It is essential that financial support of the NIH includes sufficient funds for

all facets of the research process, whether state-of-the-art DNA sequencing equipment or increased stipends for scientists-in-training.

New pathways to medical discoveries rely upon a complicated, interlocking framework of scientific infrastructure, which needs to be updated with an infusion of federal funding. Skilled personnel and premier research facilities are the foundation of

U.S. research and make medical advances happen. The more the research landscape

changes, the more researchers must have expertise outside the traditional boundaries of their disciplines, and research facilities must make this cross-pollination

possible. The fields of bioinformatics, imaging, and computer science will repeatedly

meld with biology and chemistry. These scientific cross-currents will require new

and creative training programs to produce interdisciplinary scientists, as well as

greater financial incentives to retain the best of these at federal research centers.
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RESEARCH STEWARDSHIP FUNDING

The management and support budget of the NIH is decreasing as a percentage

of the agency’s entire budget, a trend that negatively affects the best administration

of federal research dollars. This deficiency undermines the strength of the NIH and

its promise to the American public to improve health and well-being.

ECONOMIC BENEFITS

Medical advances in the past have directly minimized the cost of specific diseases. The United States spent a total of $32 million over 10 years to support the global

smallpox campaign. Economists estimate that, every 21⁄2 months since the world

was declared smallpox-free in 1977, the entire $32 million has been recouped in

health cost savings. The ongoing anti-polio campaign promises similar results: The

United States will save more than $230 million annually in vaccine costs, while

globally, the annual savings is expected to exceed $1.5 billion. At the NIH’s National

Institute of Allergy and Infectious Diseases, research costing $31.8 million produced

the hepatitis B vaccine, saving our health care system an estimated $73.7 million

to $146.6 million each year. But the price of illness in this country will grow if we

are not prepared to confront all new and costly diseases, such as antibiotic-resistant

infections and the inevitable yet-unknown pathogens. The NIH, and specifically, the

National Institute of Allergy and Infectious Diseases (NIAID), is at the center of a

national mission to stop these diseases, a mission that must be adequately funded

in the fiscal year 2002 budget.

The American Society for Microbiology, the largest single life science society with

over 42,000 scientists, appreciates the opportunity to provide these recommendations to the Senate Subcommittee on Labor, Health and Human Services and Education Appropriations and stands ready to assist the Subcommittee in any way possible.

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF TROPICAL MEDICINE AND

HYGIENE

The American Society of Tropical Medicine and Hygiene (ASTMH) appreciates the

opportunity to submit testimony to present our views on fiscal year 2002 funding

priorities to the Subcommittee.

The ASTMH is a professional society of 3,500 researchers and practitioners dedicated to the prevention and treatment of infectious and tropical diseases. The collective expertise of our members is in the areas of basic science, medicine, vector control, epidemiology, and public health.

The staggering burden of tropical and infectious diseases confronts us on a daily

basis. Poor health and the spread of infectious disease across borders have profound

effects on the social and economic development and stability of nations around the

globe. With the enormous volume of travel and trade today, and with the expanded

deployment of American troops, infectious diseases can affect populations around

the globe within 24 hours. The globalization of infectious disease has brought an increased realization that infectious diseases represent not only a humanitarian concern but also a bona fide threat to the health and national security of the United

States.

Now more than ever, we must be vigilant in our efforts to control and eradicate

infectious diseases. In this new millennium, we must marshal the efforts of government, industry, international organizations and private foundations if we are to protect our national security against biological and chemical attacks and protect Americans against infectious diseases and antimicrobial resistance. Tuberculosis (TB) and

malaria are renewed threats because they are becoming increasingly drug resistant.

Monitoring, preventing, and controlling antimicrobial resistance requires sustained

effort, commitment, and collaboration among public and private sectors, with support and leadership from the Federal Government.

NATIONAL INSTITUTES OF HEALTH (NIH)

The Society thanks the Subcommittee for your strong leadership in the area of

biomedical research and for pursuing budget increases that will effectively double

the NIH budget by fiscal year 2003. Investments in NIH have led to an explosion

of knowledge that promises to advance our understanding of the biological basis of

disease and unlock new strategies for disease prevention, diagnosis, treatment, and

cures. Congress responded to these opportunities by pursuing, in a bipartisan fashion, an effort to double the NIH budget over the five-year period of fiscal year 1999

to fiscal year 2003—and we are now over halfway to that goal. The ASTMH joins
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the Ad Hoc Group for Biomedical Research Funding in urging you to maintain support for the Congressional campaign to double the NIH budget. We seek your support for an appropriation of $23.7 billion for NIH in fiscal year 2002. This $3.4 billion (16.5 percent) increase represents the fourth step toward the bipartisan goal of

doubling the NIH by fiscal year 2003, and will allow promising research avenues

to be pursued, including the development of new vaccines and drug therapies for

diseases such as malaria, TB, dengue fever, cholera and other diarrheal diseases,

HIV/AIDS, and a myriad of other viral bacterial, fungal, and parasitic disease

agents.

As a result of the increased funding of the NIH, new scientific and research opportunities are being pursued that hold the potential to prevent and control tropical

and infectious diseases around the world. Infectious diseases are the second leading

cause of death worldwide, accounting for over 13 million deaths (25 percent of all

deaths worldwide in 1999). Twenty well-known diseases—including TB, malaria,

and cholera—have reemerged or spread geographically since 1973, often in more virulent and drug-resistant forms. At least 30 previously unknown disease agents have

been identified in this period—including HIV, Ebola, and hepatitis C—for which no

cures are available.

Additional support for clinical research is needed to take advantage of existing opportunities and develop new approaches to accelerate efforts to develop vaccines and

drug therapies for HIV/AIDS, malaria, TB, and hepatitis C. Emerging scientific opportunities and recent developments in infectious disease research include sequencing the human genome and recombinant DNA technologies for developing new vaccines, such as the very successful vaccines against hepatitis B that are now given

to all children in the United States. Although it will be a great challenge, we are

optimistic that similar such vaccines can be developed against the big three global

killers: AIDS, TB, and malaria.

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

The National Institute of Allergy and Infectious Diseases (NIAID) is the third

largest institute at the NIH, with a fiscal year 2001 budget of more than $2 billion,

a 15 percent increase from fiscal year 2000. During the past 15 years three factors

have prompted NIAID to grow significantly: the emergence of HIV/AIDS in the early

1980s; results from basic research that are now driving new approaches to solving

clinical and public health problems; and the realization that infectious diseases will

continue to emerge unpredictably and at times explosively. There are several important on-going issues relating to NIAID’s research efforts in tropical and infectious

diseases that we would like to highlight.

Acquired Immunodeficiency Syndrome (AIDS).—In the United States, an estimated 271,000 people are living with HIV, and the rate of the new HIV infections,

approximately 40,000 per year, continues at an unacceptably high level. NIAID-supported basic research identified the HIV protease enzyme as a target for antiviral

drugs, which led to the development of very potent protease inhibitors, that have

prolonged and improved the quality of life for many HIV-infected people. However,

effective, low-cost tools for HIV prevention, such as a vaccine and affordable drug

therapies, are needed urgently to bring the HIV epidemic under control.

Tuberculosis (TB).—TB is the eighth leading cause of death worldwide. One-third

of the world’s population has latent TB, constituting a huge reservoir from which

active TB can surface. Moreover, multidrug-resistant TB is an increasing problem.

Malaria.—Malaria has been undergoing a global resurgence in recent years, partially related to drug resistance, with 275 million cases occurring annually, and a

death toll estimated at 1 to 2 million, primarily children.

Hepatitis.—Hepatitis (liver inflammation) can be caused by several viruses. The

most common are hepatitis A, a food- and water-borne infection that is a particular

risk for travelers, and hepatitis B and hepatitis C, both of which are blood-borne.

We now have excellent vaccines for hepatitis A and B, but none for hepatitis C,

which kills about 9,000 Americans annually.

Emerging Infections.—There are numerous emerging infectious agents among the

viruses, bacteria, protozoa, and fungi that make up the microbial world. Because the

frequency of world travel makes the United States part of a global community, diseases that emerge in foreign countries are also health threats in the United States.

The Society commends the NIH and NIAID for their continued leadership and

focus on tropical and infectious diseases. We urge the Subcommittee to strongly support efforts of the NIAID to develop new and improved methods for treating illness,

controlling outbreaks, and preventing epidemics that continue to challenge global

health.
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Tropical Medicine Research Centers.—The NIH’s tropical disease research program is funded primarily by the NIAID. This year marks the tenth anniversary of

the International Centers for Tropical Disease Research network, established by

NIAID to build new and strengthen established partnerships between U.S. scientists

and investigators from tropical disease endemic areas; NIAID and other government

agencies with interests in tropical disease research; and academic scientists and private industry, to encourage translational and collaborative research. The Society

strongly urges that the Committee express its continued support for these unique

research opportunities.

FOGARTY INTERNATIONAL CENTER (FIC)

The Fogarty International Center (FIC) is a unique component of NIH with a

mandate to support training in biomedical research on behalf of the developing nations of the world. The ASTMH wishes to acknowledge the significant contributions

of the FIC in overall support of tropical disease research, and their efforts to train

scientists in molecular biology and molecular epidemiology techniques of relevance

to developing countries in which research collaborations will be conducted. The new

training program in clinical investigation is a necessary component of new NIH initiatives such as the HIV Prevention and Vaccine Trials Networks and other expanding human research programs in the developing world. The Society supports training local investigators as an investment in the research itself.

TRAINING/CAREER DEVELOPMENTS

It is clear to those of us who have devoted our careers to fighting tropical and

infectious diseases that we need to attract the best and brightest young students

and trainees to our field if we are to take full advantage of advances in science and

technology and to make progress in the global war against infectious diseases.

NIAID and the Fogarty International Center have taken the lead with initiatives

for training students and young scientists and clinicians in tropical medicine and

international health. However, compared to the need, there remains a shortage of

training opportunities and especially support for junior researchers at the point in

their training when they must choose between more mainstream careers in clinical

medicine or other areas or research, or the sometimes more challenging path of

tropical medicine and infectious disease research. We urge you to consider additional support for training and career development programs, which we feel are

most successful when they are integrated with research funding.

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

The ASTMH appreciates the Subcommittee’s past support for the CDC’s infectious

diseases program and requests your continued support for these critically important

public health initiatives. Increased funding will help support the development of a

national electronic disease surveillance network that will enable State and local

health departments to respond to infectious disease outbreaks and share information about infectious disease emergencies and trends. We also urge you to continue

to fund the CDC’s efforts to control global malaria.

CONCLUSION

In the 21st Century we must aggressively pursue the battle against tropical and

infectious diseases, which undoubtedly will intensify in the years ahead. We must

have adequate surveillance systems and modern infrastructure, coupled with scientific expertise in both basic and clinical research, if we are to develop the tools

necessary to rapidly respond to, and control, the threats posed by tropical infectious

diseases. We stand at the threshold of an exciting new era of medical progress, exemplified by the recent completion of the sequencing of the human genome. Opportunities for new treatments, diagnostics, cures, and preventive measures have never

been greater. We must also be prepared to confront the new challenges that will

lie ahead. The path of progress will be different in the coming era, as the demand

increases for a broader science base, more interdisciplinary research, and improved

technology.

REQUEST

The Society greatly appreciates your support for our nation’s investment in infectious disease research, control, and prevention activities. We urge you to continue

your efforts to double the NIH budget over the next five years and towards this end

we support an appropriation of $23.7 billion for the NIH in fiscal year 2002, with
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a corresponding increase for NIAID. We also request that the Committee support

increased funding for the CDC’s infectious disease activities.

The Society of Tropical Medicine and Hygiene appreciates the opportunity to express our views and for your consideration of these requests.

PREPARED STATEMENT OF THE ASSOCIATION FOR PROFESSIONALS IN INFECTION

CONTROL AND EPIDEMIOLOGY, INC.

Good morning. My name is Julie Rish McCord. I am an infection control nurse

for North Mississippi Medical Center, in Tupelo, Mississippi. I am here today representing the Association for Professionals in Infection Control and Epidemiology

(APIC). APIC is a non-profit organization representing nearly 12,000 infection control professionals who work across the continuum of health care.

APIC has long been a strong proponent of science-based programs designed to protect patients and health care workers, such as those of the Centers for Disease Control and Prevention (CDC). We are extremely concerned, however, about regulations

that are not based upon sound science and are unnecessary and costly to implement.

Specifically, I am referring to the proposed OSHA rule to prevent occupational exposure to tuberculosis (TB).

OSHA’s proposed requirements would place additional burdens on health care

providers while failing to add protection for health care workers. We are in dire

need of Congressional assistance in opposing this proposed rule. We greatly appreciate the efforts of Congressman Roger Wicker, who, at our request, sponsored language in the fiscal year 2000 appropriations bill calling for an independent study

of the proposed rule by the Institute of Medicine (IOM). This study culminated in

the publication of the report, ‘‘Tuberculosis in the Workplace,’’ issued by the IOM

on January 16, 2001. We would like to highlight seven of the report’s major findings.

One: health care workers as a group are not at increased risk;

Two: the primary risk to health care, correctional, and other workers now comes

from patients, inmates or clients with unsuspected, undiagnosed infectious TB.

There is no regulatory standard that could ever address this risk, since TB is not

even suspected in these patients;

Three: CDC guidelines for the prevention of occupational exposure to TB have

been implemented, as appropriate, and are working;

Four: OSHA overstated the risks to health care workers by using out-dated information and data from outbreaks to craft a proposed rule that is unnecessary and

would be ineffective and costly;

Five: OSHA vastly overestimated the benefit that could be derived from implementation of its proposed rule;

Six: A respiratory protection program should be tailored to the level of risk within

a facility; and

Seven: the proposed rule will not allow the necessary flexibility for organizations

to adopt the TB control measures that are most appropriate to the level of risk facing their individual workers.

The report states, ‘‘. . . if an OSHA standard follows the 1997 proposed rule it

may not offer sufficient flexibility for organizations to adopt control measures appropriate for the level of risk facing workers. To the extent that an OSHA standard

inflexibly extends requirements to institutions that are at negligible risk of occupational transmission of M. tuberculosis, the standard is unlikely to benefit workers

at the same time that it would impose significant costs and administrative burdens

on covered organizations and absorb institutional resources that could be applied to

other, potentially more beneficial uses.’’

With this information, Congress should take further and stronger action to ensure

that this rule, which will be virtually ineffective and overly burdensome to facilities,

is not issued.

I bring this message to you on behalf of my professional organization, but I am

also speaking to you today as someone who has had direct experience with TB disease. My mother was diagnosed with TB in the 1950s. In the years that followed,

my family and I stood by her side as she experienced many complications as a direct

result of TB, which contributed to her death in 1995. I can tell you from first-hand

experience that TB is a truly devastating disease. APIC cares very much about protecting health care workers (including ourselves) from TB. While the intention behind this rule may be sincere, it does not address the area of true risk.

There is no doubt that in the late 1980s, the public health infrastructure and

health care facilities were not prepared for the devastating combination of HIV/

AIDS and TB, but the incidence of TB in the U.S. is now at its lowest level ever
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recorded. TB is a public health issue, not a facility-specific issue. Health care workers are already protected from patients with known or suspected TB. In fact, the

rate of TB in health care workers is lower than the rate among the general population.

TB is a public health issue because it is in our communities and largely undetected. People with active TB disease, who go undetected, pose a risk to others until

they are identified, isolated and treated. Strengthening our public health programs

will allow us to target prevention and treatment programs to high-risk populations—particularly immigrants—provide directly observed therapy, and thoroughly

investigate all cases for spread to contacts.

With regard to this regulation, I would like to make one final point, as someone

who has lost a family member to the complications of TB. If I believed for one moment that this rule would prevent people from contracting this terrible disease, I

assure you, I would not be testifying before you today. The OSHA TB rule will offer

no added protection for workers and will be logistically and financially burdensome

for facilities nationwide. We would appreciate your assistance in halting the

issuance of a final rule.

Infection control professionals nationwide wish to thank this subcommittee for its

long-standing support of the Centers for Disease Control and Prevention (CDC), particularly with regard to funding for infectious disease programs. Through its efforts

and expertise, the CDC has been instrumental in national as well as international

efforts to control the incidence and spread of infectious disease. Since the CDC is

the primary entity responsible for safeguarding the public’s health, it is imperative

that it be granted adequate resources to perform this monumental task. APIC recommends an fiscal year 2002 funding level of $5 billion and we hope that the subcommittee will take this into consideration during the appropriations process.

APIC believes that the CDC needs more resources in order to adequately address

infection prevention and control at both the national and international levels. Infectious disease is the leading cause of death worldwide and a significant cause of

death here in the United States. APIC members, many of whom work on the front

lines in infection control and in public health capacities, recognize the urgent need

for enhanced prevention measures as well as increased surveillance.

In recent decades, significant progress has been made in the prevention and control of many infectious diseases. Today, our efforts are confounded, despite our many

accomplishments. Changes in human behavior, alterations to the environment, deterioration of our public health infrastructure, widespread antibiotic usage, and dramatic increases in international commerce and travel are factors contributing to the

proliferation of drug resistance and new and resurgent microorganisms.

For this reason, APIC also strongly supports full funding of Public Law 106–505,

the Public Health Improvement Act, which includes authorization language to address public health emergencies such as antimicrobial resistance and bioterrorism.

We are requesting:

—$4 million through fiscal year 2006, to enhance surveillance networks throughout our public health system;

—$95 million through 2006 to establish competitive grants to address core public

health capacity needs to best identify, monitor, and respond to public health

threats;

—$180 million for fiscal year 2002, through 2010, for new facilities construction

and renovating existing facilities at the CDC; and

—$40 million through fiscal year 2006, to establish an Antimicrobial Resistance

Task Force, and to establish competitive grants and demonstration programs to

conduct research and development for new antimicrobial drugs and diagnostics.

Federal funding would enhance surveillance sites, strengthen epidemiological and

laboratory response capabilities and support efforts to address emerging infectious

disease on a global level. We are hopeful that the committee will recognize the absolute necessity of this program and provide the highest possible level of funding.

Thank you for your attention to these concerns.

PREPARED STATEMENT OF THE ASSOCIATION OF MINORITY HEALTH PROFESSIONS

SCHOOLS

Mr. Chairman, thank you for the opportunity to present the views of the Association of Minority Health Professions Schools (AMHPS). I am Ronny B. Lancaster,

Senior Vice President for Management and Policy at Morehouse School of Medicine,

and President of AMHPS.

AMHPS is an organization which represents twelve (12) historically black health

professions schools in the country. Combined, our institutions have graduated 50
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percent of African-American physicians and dentists, 60 percent of all the nation’s

African-American pharmacists, and 75 percent of the African-American veterinarians.

Mr. Chairman, historically black health professions institutions are addressing a

pressing national need in carrying out their mission of training minorities in the

health professions. While African-Americans represent approximately 15 percent of

the U.S. population, only 2–3 percent of the nation’s health professions workforce

is African-American. Studies have demonstrated that when African Americans and

other minorities are trained in minority institutions, they are much more likely to:

(1) serve in medically underserved areas, (2) care for minorities, and (3) accept patients who are Medicaid dependent or otherwise poor. This is important Mr. Chairman because the gap in health status between our nation’s minority and majority

populations continues to widen due in part to the lack of access to quality health

care services in minority communities. As a result, we believe it is imperative that

the federal commitment to training African Americans and other minorities in the

health professions remains strong.

In spite of our proven success in training health professionals, and the important

contribution these professionals make, our institutions continue to face a financial

struggle inherent to our mission. The financial challenges facing the majority of our

students affect our institutions in numerous ways. For example, we are unable to

depend on tuition as a means by which to respond to any discontinuation of federal

support. Moreover, the patient populations served by the AMHPS institutions are

overwhelmingly poor. As a result, our institutions cannot rely on patient care income at a time when the average medical school gets 40–60 percent of its operating

revenue from health care services.

Mr. Chairman, due to the many challenges facing our institutions, AMHPS was

very pleased that the Department of Heath and Human Services made reducing the

health status gap between our nation’s minority and majority populations a top priority in fiscal year 2001. We look forward to continuing to work with all agencies

of the Public Health Service in fiscal year 2002 to make additional progress toward

the goal of eliminating all health status disparities by 2010.

Mr. Chairman, before I present AMHPS’s appropriations recommendations for fiscal year 2002, I would like to state for the record that these programs represent,

quite frankly, the difference between keeping the doors open or closed at many of

our nation’s minority health professions institutions.

FISCAL YEAR 2002 RECOMMENDATIONS FOR FEDERAL PROGRAMS OF INTEREST TO AMHPS

National Institutes of Health

Mr. Chairman, I would like to take this opportunity to thank you for your support

of the establishment of the National Center for Minority Health and Health Disparities at NIH last year. As you know, ethnic minorities and medically underserved

populations suffer disproportionately from virtually every major form of disease. Despite this longstanding public health problem, the former Office of Research on Minority Health at NIH had neither the authority nor the resources to adequately address the challenges in this country with respect to health status disparities.

The new National Center and its leadership now have the authority to:

—Directly support biomedical research, training, and information dissemination

focused on eliminating health status disparities.

—Serve in a leadership capacity in developing a comprehensive plan for minority

health research at NIH.

—Participate as an equal when NIH institute and center directors meet to determine research policy.

—Establish and support research programs at health professions institutions that

are studying diseases which disproportionately impact ethnic minority and

medically underserved populations.

On behalf of the minority health community, I would like to commend the subcommittee for appropriating $130 million for the National Center in fiscal year

2001. Given the immense public health challenge of eliminating health status disparities in this country by 2010, AMHPS is recommending that the National Center

receive an appropriation of $200 million in fiscal year 2002. In addition, AMHPS

strongly supports the goal of doubling the NIH budget by fiscal year 2003 and joins

with the Ad Hoc Group for Medical Research Funding in recommending a 16.5 percent increase ($3.4 billion) for NIH in fiscal year 2002.

Research Centers at Minority Institutions

The Research Centers at Minority Institutions program (RCMI) at the National

Center for Research Resources has a long and distinguished record of helping our
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institutions develop the research infrastructure necessary to be leaders in the area

of health disparities research. Although NIH has received unprecedented budget increases in recent years, funding for the RCMI program has not increased by the

same rate. Therefore, AMHPS recommends that funding for this important program

grow at the same rate as NIH overall in fiscal year 2002.

Animal Research Facilities Improvements

Minority health professions institutions have identified a pressing need to upgrade our animal research facilities in order to remain competitive in the field of

biomedical research. We are grateful for the subcommittee’s support last year of our

‘‘animal facilities improvement initiative’’ and are pleased to report that a majority

of our institutions are working with NCRR to upgrade their animal care infrastructure.

To continue this important initiative we urge the subcommittee to provide an adequate level of funding within the Developing and Improving Institutional Animal

Resources program at NCRR to assist the remaining schools in improving their animal facilities.

Extramural Facilities Construction

The minority health professions community thanks the subcommittee for its support of NCRR’s Extramural Facility Construction program over the past two years.

It is critical that our nation’s research infrastructure remain strong if we are to take

full advantage of the historic increases in biomedical research funding that the Congress has provided to NIH.

Under legislation passed last year, the authorization level for the Extramural Facility Construction program was increased from $150 million to $250 million. Moreover, the new law maintains the 25 percent set-aside for Institutions of Emerging

Excellence (many of which are minority institutions) for funding up to $50 million

and allows the NCRR director to waive the matching requirement.

Current funding for the Extramural Facility Construction program at NCRR is

$75 million. AMHPS encourages the subcommittee to continue its strong support for

this program in fiscal year 2002 by increasing its appropriation by the same percentage as NIH overall.

Research Infrastructure Development

Mr. Chairman, as we review the priorities of our member institutions with respect

to NIH, clearly most of our needs relate to institutional infrastructure, and those

programs which help our schools enhance their capabilities to compete for research

funding on a level playing field. Now that these programs are in place, we believe

there should be an effort to coordinate these infrastructure development programs

so our schools can work with NIH to approach them on a comprehensive, rather

than on a piece-meal basis. It would seem more efficient for NIH to work with our

schools to collaborate on our infrastructure needs, and coordinate efforts to help us

build our infrastructure.

Strengthening Historically Black Graduate Institutions—Department of Education

The Department of Education’s Strengthening Historically Black Graduate Institutions program (Title III, Part B, Section 326) is extremely important to AMHPS

institutions. The funding from this program is used to enhance educational capabilities, establish and strengthen program development offices, initiate endowment

campaigns, and support numerous other institutional development activities.

Mr. Chairman, we applaud the subcommittee’s leadership in securing a funding

level of $45 million (an increase of $14 million) in fiscal year 2001 for this vital program. For fiscal year 2002, AMHPS recommends an appropriation of $60 million to

continue the vital support that this program provides to historically black graduate

institutions.

Health Professions Training for Diversity at the Health Resources and Services Administration

The health professions programs supported by this subcommittee are the only federal initiatives designed to address the longstanding under-representation of minority individuals in health careers. HRSA’s Minority Centers of Excellence, Health Careers Opportunity Program, and Scholarships for Disadvantaged Students, support

those institutions with a historic mission and commitment to increasing the number

of minorities in the health professions.

Mr. Chairman, our schools and students greatly appreciate the consistent support

of this subcommittee for these important programs and recommend the following

funding levels for fiscal year 2002:
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—$40 million for Centers of Excellence (an increase of $9.4 million over fiscal year

2001).

—$40 million for the Health Careers and Opportunities Program (an increase of $7.2 million over fiscal year 2001). —$50 million for the Scholarships for Disadvantaged Students program (an in- crease of $5.5 million over fiscal year 2001).

Finally, we are working with HRSA and Bureau of Health Professions leaders to

ensure that the COE and HCOP programs continue to focus on providing support

to minority serving institutions. Recently proposed changes to the eligibility criteria

for COE, and the process for awarding HCOP grants, have raised some concerns in

the HBCU community. We look forward to working with the subcommittee to ensure

that these programs continue to benefit those institutions with the greatest need.

HHS Office of Minority Health

The HHS Office of Minority Health (OMH) plays a critical role in ensuring that

all Public Health Service agencies focus appropriate resources on improving the

health of our nation’s minority citizens. Although their task is daunting, progress

has been made thanks to the leadership of OMH.

OMH has helped our institutions directly by supporting a comprehensive study

on how our schools can better compete as health care providers and educational entities in the age of managed care. Moreover, we are working to develop a partnership with OMH in support of AMHPS’s Annual Symposium on Careers in the Biomedical Sciences. This unique event brings together over 1,000 minority and other

high school and college students each year to expose them to career and educational

opportunities in the health sciences. Many believe that this is the best program of

its type in the country.

To continue the important mission of the Office of Minority Health, we are recom- mending a funding level of $60 million in fiscal year 2002 (an increase of $11 million over fiscal year 2001).

Centers for Disease Control and Prevention

Minority populations of many ethnic backgrounds are at an increased risk of suffering from low birth weight, infectious disease, sexually transmitted diseases, tuberculosis, and other chronic disorders.

The Centers for Disease Control and Prevention has taken a leadership role in

combating these problems through its various health status disparities initiatives.

Because of the proximity of minority health professions institutions to disadvantaged, medically underserved communities, our institutions frequently partner with

CDC in support of community based, prevention and control initiatives. We encourage the subcommittee to provide CDC with an overall appropriation of $5 billion in

fiscal year 2002 (an increase of $1.1 billion over fiscal year 2001).

Mr. Chairman, once again, thank you and this subcommittee for your longstanding support of these very important programs. I appreciate the opportunity to

present the views of the Association of Minority Health Professions Schools.

PREPARED STATEMENT OF BABYLAND FAMILY SERVICES, INC.

Mr. Chairman: On behalf of Babyland Family Services, Inc. I appreciate the opportunity to submit this written testimony to you on three important initiatives: (1)

a Pediatric Health Center; (2) an Education Technology project; and (3) a Family

Violence and Child Abuse Initiative.

Babyland provides child care and early childhood education services for 750 children (0 to five years old) at eight child care centers and provides emergency shelter

and family support services to 750 other at-risk and low-income children and families. Babyland is currently Newark’s Early Head Start grantee (serving children 0

to 3 years old, pregnant teenagers, young fathers and families living with HIV/

AIDS) and has a partnership with the Newark Public Schools to provide Abbott preschool services to over 250 children. The agency has an extensive partnership with

the New Jersey Department of Human Services for the provision of child welfare,

family violence and child care services. Babyland is a leader in Newark for the promotion of accredited child care centers and has been recognized by The Annie E.

Casey Foundation as a model child and family development organization through

its 2001 Families Count Honors Program.

Babyland is a lead agency for the United Way’s Success By 6 Initiative and the

State’s Family and Children Early Education Services (FACES) Initiative which,

combined, provides early childhood support services to 2,000 children and over 20

other child care agencies and schools. Finally, Babyland and Passaic Beth Israel

Hospital have partnered to implement the Pediatric Asthma Reduction Effort
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(PARE), which is funded by the Robert Wood Johnson Foundation to develop a

model pediatric asthma education and management program for children in Newark

and Passaic.

THE BABYLAND PEDIATRIC HEALTH CENTER: WHERE HEALTHY BEGINNINGS LEAD TO

BRIGHTER FUTURES

Babyland is seeking $1 million for the rehabilitation or construction of a Pediatric

Health Center. Babyland is in a unique position, as the lead agency for several collaborative initiatives that promote the development of young children under six

years old, to launch a pediatric health initiative that will prevent and manage childhood illnesses in Newark. As part of the agency’s new multipurpose building, this

federal funding will enable the agency to include a pediatric and family health center that will directly provide basic health services to over 1,000 families and provide

health education, assessments, screening and follow-up services to 2,000 families

with children under six years old. In addition to the pediatric and family health center, the new multipurpose building will include a child care center for 137 children

(0 to 5 years old), a computer technology center, an employment training and placement center and family resource center. The new health center will particularly

focus on increasing immunizations, screening for lead poisoning, asthma management, preventive dental care services, nutrition, prenatal care, home safety, parent

education and child development, HIV/AIDS prevention and other preventive health

education.

In partnership with over 20 child care agencies, elementary schools and local

health care providers, Babyland will develop a coordinated community-based approach for residents to gain access to health care services. Increased access to health

care services will be achieved through the following methods: training for over 50

Abbott Family Workers who provide case management services for 2,000 preschoolers; parent-to-parent workshops that will be part of a series of parent and

health education workshops; and creative grass-roots efforts that will encourage

families to utilize the health center’s resources. Community outreach workers, parents, nurses and a team of other health professionals will provide health outreach,

education and services. Services will be coordinated with the Newark Department

of Health, the Newark Public Schools and other local health care service providers.

Matching Funds.—$1 million capital funding from the following: The Annie E.

Casey Foundation ($500,000 unrestricted award) and $500,000 from a lender. Operating funds will come from the United Way and the State of New Jersey. Other potential funders could include previous health-related supporters such as the Robert

Wood Johnson Foundation and the Healthcare Foundation of New Jersey.

THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN FAMILIES

The purpose of this initiative is to serve as a model educational program that

closes the digital divide among minority inner city children and families. This technological network links center and home-based child care centers and schools; community resources and service providers; educational, economic and resource information sources; training centers and administrative offices. The establishment of this

network will be a model for educating urban children and serve as a conduit for

comprehensive family support services.

The focus of this initiative is to establish the telecommunications linkages necessary for the educational development of 1,000 preschool and school-age children

and to provide computer and technology training for 2,000 parents, teachers, family

service workers and entry-level employees. As a result, this initiative will strengthen children’s educational skills; promote the self-sufficiency of and enhance the educational skills of parents; enable the agency to better track child and family needs

in order to enhance client services; and link the community to local and national

resource centers.

Computer technology is transforming the economic and social landscape of this

country by offering information and educational opportunities for individual growth

and community development. Inner-city children and residents are inadequately

prepared to take advantage of these growth opportunities. If the gap in information

technology—the digital divide—is not bridged, a large segment of society will be further polarized and left without the tools needed for full participation in society.

This technology initiative will assist clients who have no other tangible means of

becoming computer literate and of acquiring the requisite skills necessary to be informed and self-sufficient.
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Specific Provisions

—Technology Center, as part of a new multi-purpose community resource and

education center, that will provide distance learning, online and network linkages to educational institutions and community resources, professional development and training in basic and advanced computer and technology skills for

low-income parents, neighborhood residents and entry-level employees.

—Technology hardware and software (technical assistance, network installation

and expansion, wiring, modems, printers etc.) for children, parents and residents, and teaching/social service staff in classrooms, homes, family resource

centers and safe havens.

—Technology Training, Curriculum Development and Professional Development

for children, parents and residents, educational and social services staff, as well

as local, State, national and international community-based family service providers.

The initiative will benefit the following

—Children at nine child care centers (850 preschoolers) and 400 school-age children (charter school and after school/summer enrichment programs) at six centers and schools.

—Parents and family members (2,000) at 14 Babyland sites with links to community resources;

—Agency Staff (300), including teachers and family service workers, for client

tracking purposes; training and professional development; and access to community resources to be provided through workstations, wireless technology and/or

palm pilots.

—Parents and children in the home for educational instruction and support, economic and resource information, links to other parents and teachers, parenting

education (child and family health, child behavior and development, cultural

sensitivity, etc.) and professional education (ex. Certifications, GED, etc.).

—Family day care homes with links to community resources, professional education, BFS child care centers and other child and family resource centers.

—Child and family service providers, throughout Newark, New Jersey, the nation

and South Africa, who will receive training in child, family and community development.

Key Outcomes

—Enhanced early childhood development and education for children (three to 13

years old).

—Enhanced ability of inner city residents, especially low-income parents and teenagers, to learn computer and technology skills.

—Enhanced tracking of 1,500 children in center- and home-based child care facilities; teenage parents; victims of domestic violence; homeless families; and children in foster care.

—Enhanced delivery of professional development of teaching and family service

staff.

—Enhance the provision and delivery of parent education programs.

—Enhanced delivery of clinical and therapeutic services to parents and children.

—Enhanced ability to fulfill State and Federal reporting requirements and to provide community development consultation to local, State, national and international family service providers. This project received an allocation of $723,000 in the last fiscal year. But in order

for the system to be fully operational and implemented for the entire target clientele

population, an additional allocation of $2 million is being sought.

MEN FOR PEACE

Babyland is seeking $500,000 under the Administration on Children and Families

Community Services Block Grant to integrate its family violence and child abuse

prevention and crisis intervention services in order to develop a comprehensive program for 500 children and families. Key components of the initiative will include:

Intensive family reunification and permanency planning for children in foster care;

counseling for male batterers; parent education; mental health counseling; substance abuse counseling; and specialized services for at-risk men.

Babyland currently provides prevention and crisis intervention services for 500

abused and neglected children (under five years old) and 200 battered women. The

agency provides foster care services for nearly 300 children (siblings and infants, or

boarder babies). Babyland is also a lead agency for the Responsible Fatherhood Initiative, which utilizes a collaboration of several support service agencies to mentor

young men who have substance abuse problems.
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This project will enable the agency to integrate and build components of its prevention and intervention services that emphasize the utilization of men—fathers

and male role models—toward the reduction of child abuse and domestic violence.

This initiative will draw upon the strengths of specially trained male role models

in providing mentorship and parent education for young fathers, counseling for

batterers and men at risk of abuse or violence as well as outreach to fathers with

children in foster care. The project will employ innovative methods to engage and

educate young men and fathers as well as comprehensive support services that will

promote self-sufficiency and family development.

Matching Funds—$500,000 from the United Way of Essex and West Hudson and

the NJ State Department of Human Services

Thank you for your consideration.

PREPARED STATEMENT OF CANAVAN RESEARCH ILLINOIS

Dear Mr. Chairman: Thank you for hearing my testimony explaining why orphan

diseases, and Canavan disease in particular, are in desperate need of Government

funding for medical research.

Because neurodegenerative diseases are all related, there will be gains in medical

science that reach far beyond these rare diseases. Research for Canavan disease will

have a spill over effect, and ultimately help millions of Americans.

I can personally attest to the impact that Canavan disease has on the family it

affects. Canavan disease develops in early childhood and is 100 percent fatal.

Canavan disease (CD) is progressive; our children lose motor skills until eventually

they can no longer even breath or swallow. As parents, we are forced to become full

time caregivers and fundraisers, which puts a tremendous burden on the family,

both emotionally and financially.

When I found out that my precious little baby, Max, would die I thought that was

the end of the world. But, if anything could possibly be worse, it was when I realized that in addition to living with this disease my family and I would also have

to financially support medical research in order to give Max a chance. Due to the

lack of funding from our Government, we the parents of dying children, have

worked tirelessly raising money to pay for research that may help our children enjoy

a better quality of life, and possibly live longer.

While there are approximately ten families who actively raise money for research,

it is simply not enough to sustain our effort. For example, my family has been aggressively fundraising for over three years and founded a charity, Canavan Research Illinois. We have raised just under a quarter of a million dollars. Though this

may sound like a lot of money, even when combined with funds from other Canavan

foundations, it does not compare to the astronomical costs of both research and clinical trials. Orchestrating a safety trial is both time consuming and costly. Together,

families affected by Canavan disease have raised over two and a half million dollars

in five years, but we will need seven million dollars over the next three years to

continue the research that we have started.

I have dedicated my life to working towards finding a cure for Canavan disease.

My husband, Michael, Max, and I live on one moderate income, so I can work full

time as an unpaid volunteer for the public charity I co-founded. I have chosen this

path because I believe a cure can be found; it is just a matter time, and money.

However, as the mother of a very sick little boy there are many other demands on

my time. Max goes to school and therapy everyday, so I spend a great deal of time

in our van shuttling him from place to place. The time required to be a full time

caregiver for a profoundly handicapped child with multiple disabilities is in itself

a full time job. This is why I am asking for your help. Help us find a cure, but also

help us fund a cure!

Medical research is too expensive to be funded solely by private donations. We can

no longer do it. We have exhausted our resources. Our friends and family have generously donated money when they have been asked, but this has decreased over

time. We are out of resources, and our children are losing precious time. Science

cannot move ahead if it is only supported by dinner dances, raffles, auctions, and

donations from friends. I get extremely discouraged when I work forty to fifty hours

a week fundraising to save my baby and then hear from our privately funded researcher that we are out of money, again. This means we are out of hope. I have

worked too hard to stop now. So I am pleading with you, Mr. Chairman that in addition to granting additional funds to the NIH, that you encourage them to make

a concerted effort to look at granting more research funds towards medical interventions for the young children afflicted with Canavan disease. The children who are

dying now deserve a chance.
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While Canavan disease is rare, and may require millions of dollars for medical

research, the beneficiaries of this research are not limited to the Canavan children.

There are many related diseases that will benefit from this research including: Alzheimer’s, ALS, Parkinson’s, MS, Spinal Cord Injury, and Stroke.

Canavan disease is a very good model for neurodegenerative disease. It is caused

by a single mutated gene, which has been identified. The defective gene in Canavan

children is responsible for making one enzyme, which also has been identified. If

the doctors and scientists had the funds necessary to expand our understanding of

CD, we would be able to develop a treatment or cure for it and apply this knowledge

to the other neurodegenerative diseases.

If you look at all the related diseases it is clear that research in one area, will

spill over and help research in another. But the millions of dollars necessary for this

to happen have simply never been granted to the Canavan researchers who are

working on treatments that are ready to be used in human clinical trials. Testing

mice and rats for ten years will not help the people who are dying today. Because

there is no funding for the disease my son was born with, he does not have access

to any treatment.

I believe that every American is entitled to have access to some course of medical

treatment. The little children dying of Canavan disease deserve a chance. Without

Government funding they will not have that chance. Many of these children are already medical pioneers and have undergone experimental therapies to try and improve their lives, and the lives of children in generations to come but, sadly this

will come to an end. The financial burden of supporting medical research is too

much for the friends and family of a dying child. Without Government grants that

will be used towards medical interventions for the people who need help now, the

science we have all so vigorously supported will come to a screeching halt, and our

children will die.

We need research dollars now. Our children are running out of time, along with

the other people who suffer from degenerative brain diseases. We cannot do this

alone! The millions of dollars necessary to treat and cure Canavan disease will ultimately help millions of people.

Thank you for receiving my testimony.

PREPARED STATEMENT OF THE NATIONAL JEWISH MEDICAL AND RESEARCH CENTER

Mr. Chairman and Members of the Subcommittee, thank you for your support last

year and the opportunity to present this testimony regarding the National Jewish

Medical and Research Center’s proposal to build an integrated Center for Environmental Health Research and Service (CEHRS). This Center will, under one roof,

support research and provide clinical services for patients with respiratory and immune diseases with the mission of controlling or eradicating environmental and occupational illness in the Rocky Mountain Region. It will serve as a regional resource

and national model for the delivery of environmental clinical health services, conduct both basic and field research on environmental illness, and ‘‘translate’’ new

knowledge, to better inform the public and help guide rational environmental policy

by government, at both regional and national levels.

National Jewish Medical and Research Center is known worldwide for the diagnosis and treatment of patients with environmental, respiratory, immune and allergic disorders, and for groundbreaking medical research. For the past 20 years, this

century-old nonsectarian, nonprofit medical center has earned an international reputation for its treatment of environmental illness and for research leading to the

detection and prevention of environmental disorders including asthma, berylliosis,

tuberculosis, and building-related illnesses.

With funding from Federal agencies including the NIEHS, NHLBI, NIAID, EPA,

DOE, and CDC/NIOSH, as well as foundations and private industry, National Jewish has become one of the leaders in the field of environmental health. National

Jewish is deeply committed to providing accessible, affordable and high quality care

for environmentally and occupationally exposed individuals, to consulting for government and industries in the region and nationally, and to educating medical professionals and the public on matters of environmental risk and health.

Our nation faces a significant challenge for the 21st century—how to safeguard

the health of the American public from environmental hazards. We are faced with

the reality that many Americans, particularly the working poor, blue collar middle

class, minorities, children and the elderly, are exposed daily to environmental toxins

that may cause major lung, heart, immune and allergic diseases, disability and untimely death. We must find ways to better diagnose, treat and, most importantly,

prevent environmental disease. In addition, federal agencies and corporations face
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the daunting task of cleaning up environmental ‘‘sins of the past’’—without unduly

endangering the health of today’s hazardous waste workers and the members of

communities that surround them.

The State of Colorado has historically been medically underserved, in environmental health services, with fewer than 40 medical practitioners in Colorado who

are board certified to practice environmental and occupational health. While the Division of Environmental and Occupational Health Sciences at National Jewish provides consultation to industry, agriculture, community groups, and labor, its services

are outstripped by the regional need for expertise. National Jewish is forced to turn

away many patients and groups who have environmental concerns because of physical and staffing limitations at the Center. These needs range from community

groups seeking advice on the hazards of radioactivity and of metal-contaminated

soil, to industries needing help in the control of lead poisoning and biological hazard

exposures, to regional agencies seeking aid in the investigation of disease outbreaks

caused by airborne molds or tuberculosis-like organisms.

National Jewish is uniquely positioned in the Rocky Mountain region to serve as

a model health care institution for implementing innovative environmental health

programs that reduce the risk of respiratory and immune system disease. Regionally

and nationally, the diseases that are treated at National Jewish Medical and Research Center are on the rise, including asthma, diseases due to environmental tobacco smoke, building-related respiratory and allergic illnesses. National Jewish

Medical and Research Center specializes in helping both small and large regional

employers address practical issues of toxic exposure assessment, exposure control,

medical management of occupational illness, and remediation. Employees and their

employers, while aiming to make the workplace safer and more productive, often

lack enough information about the toxic effects of airborne chemicals, metals, and

organic matter that produce disability. Recent studies show that 1 in 10 hospital

admissions is related to a workplace injury or exposure. More than half of all patients seen in general medicine clinics in the central U.S. report past or ongoing exposure to one or more known toxin.

The solutions to these environmental health dilemmas are to prevent exposures

from causing disease and, if environmental exposures have already occurred, to detect disease earlier and to develop more effective treatments for disease.

National Jewish can best increase our effectiveness by housing these major activities in a single, dedicated location. The CEHRS will be a showcase for the application of the most advanced environmental science and directly to the prevention of

disease in groups of Americans at environmental risk. By showing how a multidisciplinary approach can help eradicate environmental respiratory and allergic diseases,

our Center will be a model for other centers around the country who may address

other forms of environmental illness, such as those linked to skin disease, neurologic

disorders, liver disease, and cancer. National Jewish Medical and Research Center

believes that by maintaining a tight focus of both clinical care and research in an

area of great need—the respiratory and immune systems—its Center will be able

to deliver long term solutions to the most important forms of environmental disease.

The CEHRS will meet this need by integrating the following existing and new

program components in the new Center:

The Clinic for Environmental and Occupational Health Care.—A combined adult

and pediatric outpatient clinical practice staffed by experienced environmental and

occupational health physicians and nurses who diagnose and treat environmental

disorders. Annually, this clinical group screens and evaluates more than 2,000 patients with suspected environmental or occupational lung and allergic disorders.

The Environmental Disease Prevention and Research Service.—A multidisciplinary

team of physicians, researchers, epidemiologists, industrial hygienists, and health

educators, who conduct practical research aimed at ‘‘real life’’ problems solving by

measuring airborne exposures to toxins and implementing innovative programs that

detect the effects of chemicals in individuals and in the air. The goal is to devise

practical, cost-effective solutions to reducing risks of cancer, lung fibrosis, and allergic lung disease.

The Environmental Away-Team Consultation Service.—A mobile consultation

service staffed by a team of environmental and occupational health experts who go

anywhere in the country to measure environmental exposures, monitor for disease,

and advise industrial and agricultural employers, labor, and private citizens on the

management and control of environmental hazards. This service has gone on-site to

more than 20 states.

The Respiratory Protection Program.—A mobile service that helps individuals and

corporations to educate and provide appropriate types of masks for people being potentially exposed to airborne hazards. Firefighters, hazardous waste workers, mu-
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nicipal employees, and others who encounter potentially lethal exposures to highly

toxic materials call on this service.

The Environmental Education/Community Outreach Service.—A risk communication service that utilizes the internet as well as more traditional educational approaches to deliver up-to-date, balanced, practical environmental information to

civic groups, labor, industry, and local and federal government agencies.

The Occupational and Environmental Medicine Training Program.—Based at National Jewish and the Department of Preventive Medicine and Biometrics at the

University of Colorado School of Medicine, this is the only training program for environmental medicine in the state of Colorado.

The Environmental Toxicology Section.—A research unit dedicated to understanding oxidative stress which is a natural process that produces disease when undesirable oxidant gases or dusts are inhaled, causing inflammation.

The Environmental Immunology Laboratory.—A research unit dedicated to understanding how environmental toxins cause allergic diseases.

National Jewish is the only academic research facility in Colorado that provides

clinical care for patients with suspected environmental or occupational illnesses. Patients from the region as well as from all 50 states come to National Jewish Medical

and Research Center for medical diagnosis and care. Patients receive superior care

without regard to their ability to pay. Each year $7 to $10 million of free or heavily

subsidized care is provided.

National Jewish was recently ranked as the best hospital in the nation for excellence in treating respiratory diseases in U.S. New and World Report’s ‘‘America’s

Best Hospitals.’’ American Health magazine termed National Jewish one of the finest U.S. hospitals in allergy, immunology and pulmonology for both adult and pediatric patients. The Institute for Science and medicine rated National Jewish among

the top 10 independent biomedical research institutions—of any kind—in the world,

and the only one that also provides patient care. It was ranked as one of the three

most influential research institutions for immunology and as the number one private immunology research institution in the world.

Partnerships with governmental agencies.—In addition to conducting research directly funded by several agencies, National Jewish faculty provide advice and consultation to local, regional and Federal Government offices, including: the Colorado

Department of Health and the Environment, the Governor’s Air Toxics Science Advisory Committee, the U.S. DOE Beryllium Standards Advisory Committee, oversight

Boards for Hanford Reservation in Washington State, the Nevada Test Site, and Los

Alamos National Laboratories, the EPA air pollution research advisory panel, and

the OSHA Metalworking Fluids Standards Advisory Committee, and both CDC/

NIOSH and NIH research advisory committees.

Partnership with community health organizations.—Faculty members conduct

community outreach, speaking at local hospitals on environmental health. Three of

our faculty have served as presidents of the Rocky Mountain Academy for Environmental and Occupational Medicine, the regional society for all physicians practicing

in this field.

Partnership with regional industry and labor.—National Jewish has helped organize and conduct medical education and medical surveillance programs for many regional industries, helping them to protect employees from hazards in the workplace.

National Jewish proposes to continue the public/private partnership with the Federal Government by the establishment of the ‘‘Center for Environmental Health Research and Service.’’ This partnership will cover the cost of the construction of a

new, 113,000 square foot, state-of-the-art facility which will house research in the

fields of asthma, inflammation, immunology, and environmental medicine. These

basic and clinical/translational research programs address issues that are central to

the mission of the Center for Environmental Health Research and Services. The new

research facility will be closely integrated with the clinical care, outpatient services,

and training programs that our Center for Environmental Health Research and

Services uses to translate research to improve clinical services for patients with respiratory and immune diseases such as asthma, lung fibrosis, tuberculosis, and other

lung and skin disorders which often stem from environmental and occupational hazards.

The total cost of the proposed facility and equipment is $39 million. Since fiscal

year 1999, National Jewish has received a total of $3.75 million from the Labor,

Health and Human Services, and Education Appropriations Bill under HRSA to

carry out the initial phases for the construction of the CEHRS and has privately

raised $29 million. National Jewish seeks $5.25 million in HRSA follow-on funding

in fiscal year 2002 to complete the balance of the construction request.
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PREPARED STATEMENT OF THE CHILDREN’S HEART FOUNDATION

Mr. Chairman and Distinguished Subcommittee Members: On behalf of The Children’s Heart Foundation and all who are suffering with congenital heart defects we

enter this testimony for consideration at the fiscal year 2002 budget hearing. The

Children’s Heart Foundation formally requests to be allowed to testify before the

subcommittee during hearings on appropriations for fiscal year 2002 to the National

Institutes of Health.

According to the NIH Guide: PEDIATRIC DISEASE CLINICAL RESEARCH

NETWORK (release date May 24, 2000); about 32,000 babies are born each year in

the U.S. with congenital cardiovascular malformations (CCVM). CCVM is considered

the most common or number one birth defect and a leading cause of death in infants. CCVM occurs at least three times more often than childhood cancers and significantly more often than pediatric AIDS. The mortality rate for these children may

be as high as fifty percent, depending on the condition.

The financial and social impacts on families are staggering. Many children who

survive infancy are forced into a life of dependency on medications, medical procedures, and repeated open-heart surgeries. Parents of these children will struggle

with high medical costs and low productivity when critical care is needed or when

the child dies. This trauma can throw a family into emotional and financial devastation. In 1992 nearly $500 million was spent to pay for 44,000 hospitalized children

who were under fifteen years old.

Because so few of these children live long enough to have children of their own,

it has been difficult to carry out genetic studies of CCVM. However researchers have

now come to the conclusion that most CCVM occurrences are caused by genetic deflects. According to information provided by the NHL&BI, the direct cause for at

leapt eight different structural heart defects may be genetic.

While we at The Children’s Heart Foundation applaud the genetic studies that

have been ongoing at the NIH, we also realize that clinical studies on procedures

and methods of treatment are vital to the future of patients suffering with congenital heart defects. For this reason we urge this distinguished committee to encourage the NHLBI to support more clinical research related to congenital heart defects.

In the next few pages we will present the stories of some of the families who have

lived with these life-threatening conditions. One of these families has lost the battle

while others still live with the daily difficulties that accompany their illness. Please

accept these testimonies and the request to testify before this committee under the

auspices of The Children’s Heart Foundation.

ANDREA

My name is Andrea Piwowar. Twenty-three years ago, I was born with several

congenital heart defects. I was diagnosed with tricuspid atresia with transposition

of the great arteries and a large ventricular septal defect associated with pulmonary

hypertension and an absent pulmonary valve.

When I was three months old, I had a banding of the pulmonary artery. In January of 1982, I had a modified Fontan, a surgical procedure that makes it possible

for blood to enter the lungs without being pumped in by the right ventricle. This

is achieved by connecting the pulmonary artery directly to the right atrium. In my

situation, since I had transposition of the great arteries and a ventricular septal defect along with tricuspid atresia, the underlying need for the Fontan procedure, the

surgeon corrected the transposition and closed the hole between the two atria.

Seven months following the modified Fontan, I had a stroke. In December of the

same year, I had yet another stroke. It was thought that clots were forming in the

pulmonary stump; therefore, after the second stroke, I was operated on again and

the pulmonary stump was removed. The doctors could not find where the clots came

from. As a result of the strokes, which occurred after my corrective heart operations,

I have both orthopedic and speech impairments and require the use of an electric

wheelchair for mobility purposes.

Throughout my childhood, my parents fought for the appropriate accommodations

to be made in the school systems and for my right to be in classes with able-bodied

children. I felt likes was necessary for me to work harder on class assignments just

so I could keep up with the class. I also felt that I had to prove myself to my teachers. I am proud to say I am now an Indiana University/graduate.

Like other patients who have had the Fontan operation, I am beginning to see

some of its side effects. Within two years, I have had atrial fibrillation three times,

each time requiring a cardio version to get back into normal rhythm. I also have

an enlarged atrium, which is causing my blood return to become sluggish. My first

bout with atrial fibrillation occurred during the week of college midterms. I thought
519

it might have been something that I had brought on myself from stress, but I later

found out in the hospital that it was a side effect from the Fontan procedure.

No one had informed me of any possible side effects of the Fontan. Only by speaking with my cardiologist and reading personal experiences of other Fontan patients

I am beginning to understand more about the side effects; however, I have yet to

understand why some people with congenital heart defects have strokes while others

do not. No one can explain why I had two strokes after the Modified Fontan operation.

It is my hope that as more congenital heart research is performed, researchers

may discover why some people are more prone to having a stroke than others and

find a way to prevent them from occurring.

SAM

My name is Teresa Taylor from Skokie, Illinois and I would like to address this

committee on behalf of all the children born with congenital heart defects, those surviving, and in honor of those that have lost their lives including my son, Sam.

My son Sam and countless others that have died prematurely are not forgotten

but remembered. And to be a constant reminder for the need for additional federal

funding for research on congenital heart defects.

Sam was born with hypo plastic left heart syndrome. In other words, his left side

of his heart was underdeveloped. The left side of the heart is the main pumping

chamber of the heart and pumps blood to the rest of the body.

The devastation over our son’s condition has caused us great sorrow and pain. We

knew very little in 1993 of his birth defect. There was little that we could do except

listen to the doctors’ prognosis and go along with the treatment they suggested. In

1993, the options for Sam were immediate open-heart surgery or wait for a heart

transplant. We opted to place Sam on a heart transplant list. We were told that

Sam would probably get a heart within the next 6–9 weeks. We did not receive a

heart when we had thought. The heart for Sam came when he was 5 months old.

He lived in the hospital his whole life on a ventilator. I would not call this life support but assistance so that his heart and lungs would not flood up with blood while

he waited for a heart. Sam died two weeks after transplantation. He died due to

lung and hospital related infections. Because Sam waited only two days short of the

longest wait for an infant heart doctors did not know what to expect of his outcome.

Today doctors know that an infant and most likely any patient waiting for a heart

transplant cannot survive as long as Sam did on a ventilator. Because of Sam, doctors know that it is critical to find better ways to manage a patient waiting for a

heart transplant and open-heart surgery. Today at Children’s Memorial Hospital in

Chicago, doctors have perfected open-heart surgery that would have been used on

Sam instead of transplantation (the procedure is called Norwood). Research helped

in this matter and patients like Sam helped them in their research. Sam and other

children paid with their lives to help doctors understand congenital heart defects

and find ways to better manage and treat their condition.

I have heard countless stories subsequent to our son’s death. Stories of survivors

with the same condition Sam was born with. These children are living today because of research in congenital heart defects.

JESSICA

My name is Jessica Cowin and I am 16 years old. I have had five heart surgeries

since I was four days old because I was born with a hypo plastic left heart. A hypo

plastic left heart is a heart that has no left side; in other words I had no pump.

At four days and 18 months the doctors performed closed heart surgeries on me.

At five years and 13 years, I had open-heart surgeries. All of these surgeries

worked, for a while, but my heart began to fail in the last two years. The doctors

and my parents agreed that I needed a heart transplant. It was very scary to think

that the doctors were going to put someone else’s heart inside of me, but if I wanted

to live longer that’s what I had to do.

On September 25, 1999, my mother got a phone call from the Children’s Memorial

Hospital in Chicago (where I have had all of my surgeries), saying that they had

a heart for me. It has been two months since my transplant and even though I am

on a lot of medication I already feel better. Before the transplant I had no energy

and got sick more often than other children. I have missed a lot of school in the

past three years and I missed my friends, too.

Without the research for congenital heart defects, I would not be here today. I

was born in 1983 at Children’s Memorial Hospital. At that time they were not even

doing heart transplants there. They started doing transplants in 1988, when I was

5 years old. I have personally benefited from the research of all of my five surgeries.
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PREPARED STATEMENT OF THE CITY OF MIAMI BEACH, FL

Mr. Chairman: On behalf of the City of Miami Beach, Florida, I appreciate the

opportunity to submit written testimony on an extremely important program the

City has undertaken to serve its elderly community both now and in the future. The

City is seeking $500,000 in fiscal year 2002 appropriations through the Administration on Aging for the City’s Elder Ready Community Pilot Initiative. We believe that

this pilot project can serve as a national model for aging services programs as the

nation’s population continues to age.

ELDER READY COMMUNITY PILOT INITIATIVE

The Elder Affairs Office is part of the Housing Division of the City of Miami

Beach, a public entity. The office assists the elder population in obtaining appropriate services through its information and referral service. Staff also identifies and

coordinates services available in the community and serves as a liaison with other

governmental and community based organizations. In addition, the Elder Services

Initiative includes a needs and assessment that identifies programs that will enhance senior life on Miami Beach.

As you may know, the City of Miami Beach has traditionally been a destination

for retirees. Over the last decade, the City has been revitalized as a tourist destination and as a business center attracting a younger resident population. At the same

time, from 1990 to 2000, the population group ages 44 to 65 has increased from 19.4

percent to 23.2 percent of the City’s total population. A key component of the Elder

Services Initiative is the Elder Ready Communities Initiative that was developed by

the Florida Department of Elder Affairs and was officially announced during Older

Americans Month, May 2000. It seeks to enhance recognition of both the value of

elders to Florida’s communities and the need to plan for the accelerated demographic changes over the next ten years as the ‘‘baby boomer’’ generation reaches

seniority. In order to seek the designation of the City as an Elder Ready Community, the Elder Affairs Office requests direct funding through the to undertake a

comprehensive assessment of its elder community in regard to housing, transportation, city infrastructure, the business community and the availability of services.

The City of Miami Beach estimates that the cost of implementing an Elder Ready Pilot Program will be $500,000. The City has currently allocated an annual budget

of $65,000 in general funds for its Elder Affairs Programs. In addition, the City has

committed fiscal year 2000/2001 Community Development Block Grant funds in the

amount of $90,000 and $65,000 in general funds to local providers of services to the

elder community.

At this time, the City of Miami Beach is not receiving funding for this pilot program from any other Federal agency.

Florida is at the forefront of elder related issues that will greatly impact the rest

of the country during the next decade. Florida has the largest proportion of elders

of any state in the nation and all projections indicate that this will continue to be

the case for the foreseeable future. The Florida Department of Elder Affairs leads

the country in its creation of the Elder Ready Communities Initiative. The findings

of this pilot project could be replicated in other municipalities across the country

as the population continues to age. Through research, surveys and the ongoing commitment of the community, new and innovative systems can be implemented for the

health and vitality of the entire City as well as for the rest of the country.

We hope you will find this critically important pilot project worthy of your support.

Thank you for your consideration.

PREPARED STATEMENT OF THE CITY OF NEWARK, NJ

Dear Mr. Chairman: The City of Newark, NJ hereby submits for the record, testimony regarding three innovative projects that are of great importance to the State

of New Jersey’s largest City. The projects described below each address an aspect

of the needs of Newark’s low income population. They are: (1) the Emergency Medical Services Demonstration Project, (2) the Children’s Health Care Services and

Outreach Center and (3) Babyland Family Services-A Solution to the Digital Divide

among Urban Families.

NEWARK COORDINATED EMERGENCY MEDICAL SERVICES DEMONSTRATION PROJECT

The objective of Newark’s Coordinated EMS Demonstration Project is to develop

a coordinated model for a City-wide system for efficient patient transportation and

emergency services utilization, tracking and billing. Funding is requested to assist
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in the design and implementation of a system which will assure transportation of

patients to the appropriate specialty hospital or other medical facility. The system

will include a billing and service allocation component to reduce inefficiencies and

deter fraud, waste and abuse. The system will be coordinated with the City’s 911

integrated dispatch, to insure the timely transfer of calls and delivery of services.

The City’s dispatch center handles over 300,000 calls for service per year, and must

efficiently channel calls for medical service to the EMS system in a manner that

allows for tracking of services while transferring operational responsibility. Over

100,000 calls for service per year go to the Emergency Medical Services system in

Newark.

Currently, the City of Newark contracts with the University of Medicine and Dentistry of New Jersey (UMDNJ), through University Hospital, to provide a complete

system of dedicated 911 emergency medical services. These services include: basic

life support units integrated with advanced life support services, emergency treatment and transportation to local area hospitals as defined in an Approved. Hospitals

for Patient Transport policy, heavy rescue and vehicle extrication, and service as the

lead agency in response to mass casualty incidents within the City. UMDNJ provides centralized medical dispatch communications per NJ State requirements, and

the interface with City E911 services is crucial to both efficient and effective dispatching, as well as to securing appropriate and adequate reimbursement for services.

The combination of an increase in the number of calls for service, tremendous advances in available technology, and pressures on the billing system present both a

challenge and an opportunity for a unique demonstration project. The City of Newark’s Police Computer Aided Dispatch system is the central point for 911 emergency

calls, and calls to it for medical assistance are transferred to UMDNJ. However,

calls for assistance can also be placed directly to the emergency medical assistance

provider. There is no integrated system which can track all calls, the disposition of

them, and ultimately, the payment for them. The reimbursements paid by the City,

Medicaid, Medicare, the State’s Charity Care system, and managed care providers

do not cover the cost of capital expenditure for system upgrades. Further, the integration of the City’s E911 system with the UMDNJ system cannot currently be

funded through municipal sources, due to other needs and demands. The City is

now unable to track and verify EMS services and billing to residents and/or third

parties for which it is responsible. Therefore, an allocation of $5 million is requested

to establish a much needed demonstration project for an integrated system for coordinated delivery of emergency medical services.

NEWARK CHILDREN’S HEALTH CARE SERVICES AND OUTREACH CENTER

The objective of the Newark Children’s Health Care Services and Outreach Center

is to positively impact on the health of Newark’s children through the development

of a coordinated health care system that will allow the City to bring health care

services to the community. The Children’s Health Care Services and Outreach Center will provide a coordinated approach to offering health and social services to uninsured/underinsured pregnant women and children between the ages of 0 through

5. The City’s Department of Health and Human Services will partner with other

community organizations and hospitals to provide a full spectrum of health, social

services and mental health services. At minimum, the Center will provide services

that include, pre-conception counseling, early pregnancy testing, pre-natal care, substance abuse counseling and referral services, family counseling, pediatric practice

with related services including WIC, immunization, nutritional counseling and case

management services. Health education will be offered to develop parenting skills

and managing households.

Through the use of focus groups, the DHHS will assess and re-evaluate Newark

residents’ use of existing services. Focus groups will be conducted to analyze barriers to services and residents utilization rates. Based upon the analysis, the DHHS

will design the Children’s Health Services and Outreach Center as a consumer

friendly service center.

The City of Newark has been designated by the Centers for Disease Control and

Prevention as a pocket of need for children. An analysis of trends in the City of

Newark reveals that one-fifth of Newark resident births in 1996 were to teenage

mothers (under age 20). Teenage mothers have accounted for 1 in 5 Newark resident births from 1989 through 1996. Over one-half of Newark resident women who

delivered in 1996 began pre-natal care in the first trimester of pregnancy. In contrast three fourths of all New Jersey mothers giving birth in 1996 began pre-natal

care in the first trimester. Since 1989 the percentage of Newark mothers receiving

pre-natal care in the first trimester has generally declined for all age groups. In
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fact, the rate of mothers giving birth in 1996 who received no pre-natal care was

six times as high for Newark (8.3 percent) as for the State as a whole (1.3 percent).

By race, nearly 12 percent of black mothers in Newark and 3 percent of white mothers received no pre-natal care.

In 1996 the number of Newark resident infant deaths 80, a 14.3 percent increase

over the 70 infant deaths in 1995. Notwithstanding this one year increase, the number of resident infant deaths in Newark decreased from a high of 189 deaths in 1989

to the current level. Neo-natal deaths have been increasing over the past 8 years,

from 52 percent of the total infant deaths in 1989 to 58 percent in 1996. The leading

cause of death for infants in Newark in 1996 is low birth-weight. The second leading

causes of death were congenital anomalies and sudden infant death syndrome.

Other ailments that affect the health of Newark children include pulmonary dysfunctions such as asthma and lead poisoning. As of December 31, 1998, Newark had

a caseload of 1,613 children under age six with blood lead levels over 20 ug/dL. In

1998 an average of 25 percent of nearly 2,000 children tested had blood lead levels

over 20 ug/dL.

In addition to services available at the Center, there will be an outreach team

that will provide Newark residents with a mechanism that will link them to all

services currently provided within the City of Newark, and that are identified

through the focus groups. Teams will be assigned to identified neighborhoods, and

will be comprised of a Public Health Nurse, Social Worker and Outreach worker.

The teams will be responsible for visiting Newark children as well as older residents

and assessing health and service needs. Working in coordination with neighborhood

community based organizations, city-wide faith based agencies and area hospitals,

citizens will be provided with referrals for care and services. There will be specific

emphasis on reaching young mothers and their children who have not been previously involved with the health care system and available services.

Through the centralization of services, we believe that we can increase access to

the array of health and social services needed by Newark residents to raise healthy

children. The City seeks $2.5 million from the Centers for Disease Control (CDC)

to support this initiative.

BABYLAND FAMILY SERVICES, INC.

THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN FAMILIES

The purpose of this initiative is to serve as a model educational program that

closes the ‘‘digital divide’’ among minority inner city children and families. This

technological network links center and home-based child care centers and schools;

community resources and service providers; educational, economic and resource information sources; training centers and administrative offices. The establishment of

this network will be a model for educating urban children and serve as a conduit

for comprehensive family support services.

The focus of this initiative is to establish the telecommunications linkages necessary for the educational development of 1,000 preschool and school-age children

and to provide computer and technology training for 2,000 parents, teachers, family

service workers and entry-level employees. As a result, this initiative will strengthen children’s educational skills; promote the self-sufficiency of and enhance the educational skills of parents; enable the agency to better track child and family needs

in order to enhance client services; and link the community to local and national

resource centers.

Background: Computer technology is transforming the economic and social landscape of this country by offering information and educational opportunities for individual growth and community development. Inner-city children and residents are inadequately prepared to take advantage of these growth opportunities. If the gap in

information technology—the digital divide—is not bridged, a large segment of society will be further polarized and left without the tools needed for full participation

in society.

Babyland has been a major non-profit child and family service organization in

Newark, New Jersey for over 33 years and currently provides comprehensive child

and family development services to 1,500 at-risk children and their families each

year. BFS programs provide a continuum of educational services to individual children from infancy to 18 years old (including teenage mothers and young fathers) as

well as multiple support services for family members. The agency is able to build

extensive relationships with families and to provide follow-up care. As a result,

Babyland is in a unique position to launch and oversee a major computer and technology initiative that will provide extensive training and technology support for individual families. This technology initiative will assist clients who have no other
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tangible means of becoming computer literate and of acquiring the requisite skills

necessary to be informed and self-sufficient.

Specific Provisions

—Technology Center, as part of a new multi-purpose community resource and

education center, that will provide distance learning, online and network linkages to educational institutions and community resources, professional development and training in basic and advanced computer and technology skills for

low-income parents, neighborhood residents and entry-level employees.

—Technology hardware and software (technical assistance, network installation

and expansion, wiring, modems, printers etc.) for children, parents and residents, and teaching/social service staff in classrooms, homes, family resource

centers and safe havens.

—Technology Training, Curriculum Development and Professional Development

for children, parents and residents, educational and social services staff, as well

as local, State, national and international community-based family service providers.

The initiative will benefit the following

—Children at nine child care centers (850 preschoolers) and 400 school-age children (charter school and after school/summer enrichment programs) at six centers and schools.

—Parents and family members (2,000) at 14 Babyland sites with links to community resources;

—Agency Staff (300), including teachers and family service workers, for client

tracking purposes; training and professional development; and access to community resources to be provided through workstations, wireless technology and/or

palm pilots.

—Parents and children in the home for educational instruction and support, economic and resource information, links to other parents and teachers, parenting

education (child and family health, child behavior and development, cultural

sensitivity, etc) and professional education (ex. Certifications, GED, etc.).

—Family day care homes with links to community resources, professional education, BFS child care centers and other child and family resource centers.

—Child and family service providers, throughout Newark, New Jersey, the nation

and South Africa, who will receive training in child, family and community development.

Key Outcomes

—Enhanced early childhood development and education for children (three to 13

years old).

—Enhanced ability of inner city residents, especially low-income parents and teenagers, to learn computer and technology skills.

—Enhanced tracking of 1,500 children in center- and home-based child care facilities; teenage parents; victims of domestic violence; homeless families; and children in foster care.

—Enhanced delivery of professional development of teaching and family service

staff.

—Enhance the provision and delivery of parent education programs.

—Enhanced delivery of clinical and therapeutic services to parents and children.

—Enhanced ability to fulfill State and Federal reporting requirements and to provide community development consultation to local, State, national and international family service providers.

This project received an allocation of $723,000 in the last fiscal year. But in order

for the system to be fully operational and implemented for the entire target clientele

population, an additional allocation of $2 million is being sought.

The City of Newark wishes to express its deep appreciation to this Committee for

permitting the presentation of these important projects. Your positive response for

Newark’s request for support will have a positive impact on the health and wellbeing of Newark’s citizens.

PREPARED STATEMENT OF MISSISSIPPI STATE UNIVERSITY

Mr. Chairman and Members of the Subcommittee, thank you for the opportunity

to submit this testimony regarding the National Institutes of Health Institutional

Development Award (IDeA) program. I am Dr. Robert Altenkirch, and I am VicePresident for Research at Mississippi State University. I also serve as EPSCoR
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1 Alabama, Alaska, Arkansas, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, North Dakota, Oklahoma, Puerto Rico, South Carolina, South Dakota,

Vermont, West Virginia, and Wyoming.

State Project Director in Mississippi. I submit this testimony on behalf of the Coalition of EPSCoR States.1

I would like first to express my gratitude to Senator Cochran for his strong support of the IDeA program and the related Experimental Programs to Stimulate

Competitive Research (EPSCoR) in other federal agencies. Senator Cochran has

been a strong advocate of IDeA because he understands the importance of enhancing our nation’s biomedical research infrastructure by building the research capacity

of Mississippi and the other IDeA states. We Mississippians greatly appreciate his

leadership on IDeA and a whole host of issues important to Mississippi. We are

proud to have him represent us in the United States Senate.

IDeA was authorized by the 1993 NIH Revitalization Act (Public Law 103–43).

IDeA works to improve our nation’s biomedical research capacity by enhancing the

capability of states that have not yet substantially participated in the NIH’s research endeavors. The NIH has identified the following states as eligible for IDeA

funding: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana,

Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico,

North Dakota, Oklahoma, Rhode Island, South Dakota, South Carolina, Vermont,

West Virginia, Wyoming and the Commonwealth of Puerto Rico. IDeA acknowledges

that nearly one-half of the states do not have an adequate R&D infrastructure in

the biomedical sciences. Clearly this is not in the long-term best interest of our nation.

IDeA is important, Mr. Chairman, because NIH research funds are extremely concentrated geographically. The 24 states that participate in IDeA received just 5.3

percent of NIH research funding over the fiscal year 1994-fiscal year 2000 period,

while the top state alone received nearly three times that amount. The five most

successful states combined received 48 percent of NIH funding over the same period.

For example, according to data compiled by the Social Science Research Center

at Mississippi State University, Mississippi received $20 million in NIH research

funding in fiscal year 1999, compared with a national average of nearly $250 million

per state. Alaska received just $2 million, Idaho received $3 million, and New

Hampshire received $50.3 million—all a fraction of the national average.

Our country has embarked on a great endeavor: to increase substantially the NIH

research budget—possibly even doubling research funding over the next five to

seven years. Many scientists and Members of Congress support this worthy goal,

and I applaud this important effort.

While I strongly support efforts to increase biomedical research funding, I think

it crucial that all regions of the country participate in this effort—not just existing

centers of excellence in a small handful of states. If we are to double research funding we need to enhance our research capacity by including a greater portion of the

country in our research endeavors. Every region of the country has talent to contribute to our nation’s biomedical research efforts—and every region of the country

should have the opportunity to nurture and develop their talent pool into individuals and centers that can compete successfully for NIH funding and develop the biomedical R&D base across our nation.

The 24 IDeA states have fine research institutions that are home to many talented researchers. The institutions and researchers in these 24 states should play

a significant role in our nation’s effort to expand research capacity; they are crucial

to any serious effort to improve our nation’s ability to treat, cure and prevent disease.

Mr. Chairman, the Congress provided the NIH with $20.3 billion in fiscal year

2001—an increase of $2.5 billion or 14 percent above the fiscal year 2000 level. It

is the largest increase that NIH has ever received, and I understand the NIH could

receive an increase this year as well. Mr. Chairman, the Subcommittee was helpful

last year in providing IDeA with an increase, and we sincerely appreciate the Subcommittee’s support. While last year’s appropriation for IDeA is definitely a step in

the right direction, we believe IDeA should be funded at $200 million or more.

We ask you to provide $200 million for IDeA in fiscal year 2002—a small fraction

of the likely NIH increase. Building the research capability of the 24 IDeA states

is crucial toward the goal of increasing and enhancing our nation’s research capability. On behalf of the Coalition of EPSCoR States, I thank the Subcommittee for

the opportunity to submit this testimony.
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PREPARED STATEMENT OF THE COALITION FOR HEALTH FUNDING

Mr. Chairman, the Coalition for Health Funding is pleased to provide the Subcommittee with testimony recommending fiscal year 2002 funding levels for the

agencies and programs of the Public Health Service. Since 1970, the Coalition’s

member organizations, representing 40 million health care professionals, researchers, lay volunteers, patients and families, have been advocating for adequate resources for the agencies and programs within the Public Health Service. The Coalition for Health Funding is the nation’s oldest, most broadly based alliance focused

on the breadth of discretionary health spending.

The Coalition sincerely appreciates the strong and continued support that the

Subcommittee has given to health discretionary programs in the past. The Coalition

recognizes the considerable funding limitations that the Subcommittee is likely to

face in fiscal year 2002, but the Coalition urges you to seize every opportunity, as

the process moves forward, to fund increases for critical public health programs.

On the cusp of the second year of the 21st Century, the nation, and the world,

are at an unprecedented nexus of great promise and potential disaster. If we devote

adequate resources to research opportunities at the National Institutes of Health we

have the potential to advance our understanding of the biological basis of disease

and unlock new strategies for disease prevention, diagnosis, treatment and cures.

But we will not fully reap that potential for all Americans if we do not also invest

in the other agencies and programs of the U.S. Public Health Service. We will not

fully reap our investment in biomedical and behavioral research if we do not also

invest in a strong public health infrastructure at the local, state, and federal level;

translate biomedical and behavioral research into community-based prevention

strategies; provide needed services for medically underserved populations; assure a

well-distributed health and public health workforce in adequate numbers; and develop and translate the most cost-effective implementation of biomedical and behavioral research into medical practice. If we do not also do these things we risk disaster in the form of soaring medical care costs as the cohort of baby boomers ages

with a host of preventable chronic diseases and there are not enough nurses, and

other essential health care personnel, to care for them. We risk disaster if we do

not continue to strengthen our seriously weakened public health infrastructure at

the local, state and federal levels to prepare for a bioterrorist attack, a major outbreak of infectious disease such as the world experienced in the 1918 with pandemic

flu, and to curb rapidly growing resistance to antibiotics used to treat serious bacterial infections. We risk disaster if we do not continue to try to meet growing demand for basic health and medical care services, particularly for mothers and children. A community is only as healthy as its weakest members. Failure to fully immunize children, adolescents, and vulnerable adults puts everyone at risk. Failure

to respond to the health, mental health, and substance abuse needs of millions of

uninsured Americans undermines the health of our workforce and undermines the

health of our economy.

These are the major public health challenges ahead in the 21st Century. To address them and reap the potential of enormous positive returns requires adequate

investment across the continuum of public health activity. The coalition’s members

recognize that no one component of the public health continuum can be effective in

achieving the overall goal of improved health outcomes without the strong support

of the components.

Each year, the Coalition for Health Funding works with other health alliances to

determine an appropriate level of federal support for all health discretionary programs. For fiscal year 2002 the Coalition is recommending $44.2 billion be provided

to address the nation’s needs in the areas of biomedical, behavioral, and health services research; disease prevention and health promotion; health services for medically

underserved populations; health professions education; and substance abuse and

mental health services. The Coalition’s recommendation also includes funding for

the Indian Health Service and the Food and Drug Administration, which are not

within the jurisdiction of this Subcommittee, but are important agencies within the

U.S. Public Health Service. The Coalition appreciates that these funding levels, 20

percent over fiscal year 2001, may appear excessive, but they reflect both the professional judgment within the various agencies as well as our own members’ assessment of community and national need. The Coalition presents these recommendations to the Subcommittee in the hope that it will view them as important targets

for optimal health outcomes.

The following is a partial list of the Coalition’s findings and recommendations; the

attached table provides the Coalition’s recommendations for all the public health

agencies:
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NATIONAL INSTITUTES OF HEALTH (NIH)

The Coalition supports an additional $3.4 billion in funding for NIH in fiscal year 2002, for a total of $23.7 billion, as the fourth installment toward doubling the NIH

budget by 2003. But in recognition of the difficulty in achieving this goal, the Coalition cautions that this increase must not come at the expense of other public health

programs.

The Coalition recognizes the critical importance of the research conducted at the

NIH and that increases provided in fiscal year 1999, 2000, and 2001 must be continued in order to fully reap our investment. Three main reasons for continuing on the

path to doubling the NIH budget include the many research challenges still confronting us, the burgeoning scientific opportunities that are now available in this

post-genomic world, and the large economic benefits that accrue as we make

progress against diseases. Examples of past investments in NIH research that have

yielded important benefits include identifying a gene that contributes to susceptibility to type 2 diabetes, developing a vaccine to nearly eliminate infections caused

by Haemophilus influenzae type b, using magnetic resonance imaging (MRI) measurements to predict who will get Alzheimer’s disease, making landmark strides in

the diagnosis and treatment of depression and schizophrenia, uncovering a hormone

involved in the onset of osteoporosis, and growing replacement heart valves in the

laboratory.

The Coalition appreciates that medical research is a vision not a precise blueprint.

It must be flexible enough to respond to society’s changing health care needs and

dynamic enough to open the way to ever more promising frontiers of fundamental

research. Scientific discoveries are the result of a series of incremental steps that

pave the way for future breakthroughs. This process needs sustained support. With

it, and support for other public health partners, we will be ready to meet the challenges of the future.

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

The Coalition for Health Funding recommends an overall funding level of $5 billion for CDC in fiscal year 2002. The Coalition believes this is the amount needed

to enable CDC to carry out its vital mission of disease prevention and health promotion.

The Coalition is very pleased that Congress provided $181 million in fiscal year

2001 to continue the process of re-building the nation’s seriously eroded public

health infrastructure in order to prepare for bioterrorism. The Coalition notes that

landmark legislation passed last year, the Public Health Threats and Emergencies

Act, builds on the three years of bioterrorism funding, to further strengthen public

health infrastructure at all levels of government, but particularly the local and state

levels. The Act authorizes $524 million in fiscal year 2002 to address three major

threats: bioterrorism, antimicrobial resistance and major infectious disease outbreaks. The Coalition urges the Subcommittee to provide full funding for this critical effort; strengthening basic public health capacity also lays a foundation for addressing all disease and disabling conditions.

CDC administers many programs that utilize the research findings of the National Institutes of Health, and other public health agencies and programs, to develop community-based strategies to prevent disease and disabling conditions and

promote improved health. Programs needing increases include those addressing

chronic and environmental diseases such as cardiovascular diseases, diabetes, cancer, and asthma. This program line received a substantial, 40 percent increase in

fiscal year 2001, but because there are over 40 separate programs included, some

received significant increases, others small increases, and some no increases. Chronic diseases combined constitute the nation’s most costly health problem, but we still

do not reach all states with adequate funding to implement cost-saving and life-enhancing prevention efforts.

In the area of infectious diseases, the Coalition believes that significant increases

are needed to enable CDC to fully implement its comprehensive plan, ‘‘ Preventing

Emerging Infectious Diseases: A Strategy for the 21st Century.’’ In today’s global

society, it is possible for a new disease to spread internationally within days, perhaps hours. Since 1973, more than 35 new infectious diseases have been identified,

including E. coli 0157:H7, airborne Ebola virus, and West Nile virus. Serious challenges lie ahead as these newly emerging and re-emerging diseases are identified,

while at the same time, multi-drug resistant organisms, such as Staphylococcus

aureus, proliferate. More than 90 percent of strains of Staphylococcus aureus in U.S.

hospitals are resistant to penicillin. In some areas of the United States, more than

30 percent of the pneumococci resist penicillin, a drug once effective against almost

all pneumococcal pneumonia and meningitis.
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Increases are also needed for prevention of HIV transmission, which is receiving

new focus within CDC. Prevention of HIV transmission is our best defense against

the AIDS epidemic that has already killed over 400,000 U.S. citizens and is devastating the populations of nations around the globe. There are 40,000 new infections every year with one-half occurring in individuals under the age of 25.

Elimination of TB and STDs, especially syphilis, are now within our grasp. These

welcome opportunities, if adequately funded now, will save millions in annual

health care costs in the future.

Finally, also in the area of infectious diseases, significant increases are needed for

immunization. An important IOM report on immunizations published last year entitled, Calling the Shots, stated that unstable funding for state immunization programs threatens coverage for specific populations and age groups. The report recommended an increase of $75 million for CDC’s operations/infrastructure state

grant program. Congress provided $42.5 million of this increase in fiscal year 2001;

the full increase is needed in fiscal year 2002. In addition, significant increases are

also needed for the domestic vaccine purchase program to meet the costs of the

newly recommended pneumococcal conjugate vaccine, as well as the costs of expanding vaccines to the 1 million two-year-olds that are not fully vaccinated, and to adolescents and adults. Finally, increases are also needed for CDC’s global immunization program.

In response to legislation enacted last year, CDC has created a new Center on

Birth Defects and Developmental Disabilities. This exciting, strengthened focus on

many preventable diseases and disabling conditions, as well as on improving the

lives of those who live with disabilities, also needs new resources.

The Preventive Health and Health Services Block Grant is the only source of

flexible funding to enable state public health officials to achieve Healthy People

2010 goals, address health gaps in discretionary funding, and respond to unexpected

crises such as the emergence of West Nile Virus. The Block Grant was cut nearly

$15 million (10 percent) in fiscal year 2000 to $135 million and level funded in fiscal

year 2001. State health officials are requesting a 50 percent increase in the Prevention Block Grant for fiscal year 2002.

Prevention Centers and Prevention Research, important programs in the nation’s

foremost health prevention agency, should receive significant increases reflecting

their importance. Prevention research is mentioned as a priority area in President

Bush’s February budget blueprint.

Other important programs needing increases are: the National Center for Health

Statistics, NIOSH; health disparities demonstration research; and injury control.

HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

The Coalition for Health Funding recommends an overall funding level of $6.7 billion for HRSA in fiscal year 2002. This is the total funding level that the Coalition

believes is needed to provide adequate resources for the important programs that

HRSA administers that address access to needed medical and health care services

for medically underserved populations.

The Coalition is pleased that the President has expressed his support for the effort to double funding for the Consolidated Health Centers program over the next

five years. Last year, Congress provided the first down payment on this goal bringing the current funding levels to $1.169 billion. The Coalition for Health Funding

supports a second down payment in fiscal year 2002 to help reach the goal of building 1,200 new health center sites and doubling the patient capacity of the entire

health center program over the next five years.

The Coalition’s recommendation also includes increases for the programs of the

Ryan White CARE Act. HIV/AIDS is an extremely serious epidemic facing Americans and people throughout the world. The programs of the Ryan White CARE Act

target needed health care, and other support services, including expensive drug

therapies, to Americans suffering from HIV/AIDS.

The Coalition supports an increase for the Title X family planning program in fiscal year 2002. This funding would support 4,600 family planning clinics across the

United States. It would pay for comprehensive services including screenings for cancer, HIV, and other diseases as well as contraception, and teen pregnancy prevention including educational activities that encourage young people to postpone sexuality.

Preliminary information indicates the President’s budget may cut funding for

Graduate Medical Education for free-standing children’s teaching hospitals which

was a new initiative in fiscal year 2000, and received $235 million in funding in

fiscal year 2001. This important program that trains physicians that provide direct

care for children, needs to continue, and needs increased, not decreased, funding.
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The Coalition also supports increased funding for the Children’s Emergency Medical

Services program which ensures that emergency care provided for children is appropriate for their specific needs, and funding at the authorized level for HRSA’s new

trauma care program.

The Coalition is disappointed that the Maternal and Child Health Block Grant has been level funded for the past several years at $710 million. This program provides comprehensive, preventive care for mothers and young children, as well as an

array of coordinated services for children with special needs. MCH programs are facing increased demands for services due largely to two trends: continued growth in

the numbers of uninsured that is outpacing targeted efforts, such as the Child

Health Insurance Program, to cover them; as more eligible children for CHIP are

identified, often by MCH outreach efforts, more children are identified as needing

MCH services. This increased demand, and the findings of a recent Institute of Medicine report entitled, From Neurons to Neighborhoods, which concludes that new

science about early childhood development demonstrates urgent need to expand the

kind of services that the MCH Block Grant provides, the Coalition believes this program should be funded at its fully authorized amount in fiscal year 2002.

The Coalition is also very disappointed that the President’s budget blueprint proposes to cut the Health Professions and Nursing Education Programs. These programs provide support to students, programs, departments and institutions to improve the racial and ethnic diversity, accessibility, and quality of the health and

public healthffff workforce. In particular, these programs help meet the health care

delivery needs of over 2,800 Health Professions Shortage Areas in this country, at

times serving as the only source of health care in many rural and disadvantaged

communities. The Coalition believes this program needs increased, not reduced,

funding in fiscal year 2002.

The Coalition sincerely appreciates this opportunity to provide its fiscal year 2002

funding recommendations to the Subcommittee for the agencies and programs of the

U.S. Public Health Service. The Coalition’s recommendations for all of the public

health agencies is provided in the accompanying table. The Coalition, and its member organizations, look forward to working with the Subcommittee in the weeks

ahead to improve the health of all Americans.

DISCRETIONARY HEALTH PROGRAMS

[B.A. in millions of Dollars]

Fiscal year

Difference Percent 2001

appropriation

2002 CHF

recommendation

CDC ..................................................... $3,868 $5,000 ∂$1.1b ∂29

NIH ...................................................... 20.3b 23.7b ∂3.4b ∂16.7

HRSA ................................................... 5,557 6,700 ∂1.1b ∂20

SAMSHA ............................................... 2,958 4,057 ∂1.1b ∂37

AHRQ ................................................... 270 400 ∂130m ∂48

FDA ...................................................... 1,217 1,399 ∂182m ∂15

IHS ...................................................... 2,598 2,848 ∂250m ∂9

OPHS ................................................... 165 181 ∂16m ∂9

Total Public Health ............... 36,933 44,285 ∂7,352 ∂20

PREPARED STATEMENT OF THE COALITION OF NORTHEASTERN GOVERNORS

The Coalition of Northeastern Governors (CONEG) is pleased to provide testimony for the record to the Senate Appropriations Subcommittee on Labor, Health

and Human Services, Education and Related Agencies as it considers fiscal year

2002 and advance fiscal year 2003 appropriations for the Low Income Home Energy

Assistance Program (LIHEAP). The CONEG Governors appreciate the support provided by the Subcommittee in maintaining this important program, and urge the

Subcommittee to increase funding for both fiscal year 2002 and advance funding for

fiscal year 2003 to the full authorized level. In addition, we are requesting that the

full authorized funding authority be provided for each year to allow for the release

of emergency funds for unforeseen circumstances, such as price spikes in natural

gas or heating oil, severe weather and other potential emergencies.
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During the current fiscal year, LIHEAP has played an essential role in making

home energy affordable for the region’s very low-income households—the elderly and

disabled on fixed incomes, families with young children, and those making the difficult transition from welfare to work. Two-thirds of the region’s LIHEAP recipients

have annual incomes of less than $8,000 per year. For many of these households,

annual income is not sufficient to pay high winter heating bills, even in periods of

economic growth. Many low-income residents are forced to choose between heating

their homes or purchasing food or vital medications.

The recent rise in winter heating fuel prices has hit these vulnerable citizens especially hard. Price volatility adversely affects the low-income households who, without disposable income to purchase fuels off-season, typically enter the market when

demand and price are high. The percentage of household income spent on energy

by low-income residents can be significant. Program funds are targeted to those

households with high energy burdens, averaging 18 percent of household income—

compared with 6.7 percent for all households.

This increase in the price of home heating fuels has created a heightened demand

on the states’ LIHEAP programs. The projected need far outweighs the available

funding. States in the region have seen increases as high as 33 percent in their regular caseloads as well as significant increases in requests for emergency assistance

from those households in imminent danger of a fuel service cut-off.

The $600 million in LIHEAP contingency funding provided by Congress in the fiscal year 2000 supplemental appropriations bill was essential in ensuring that lowincome households could heat their homes this winter, and the states are deeply appreciative of Congress’ action. Even with these contingency funds, the program currently serves less than 20 percent of citizens who qualify for LIHEAP assistance.

While there will always be true crises that call for emergency funding, an increase

in the regular LIHEAP appropriation for fiscal years 2002 and 2003 to the full authorized amount will enable the states to more fully implement cost-effective measures to meet the continuing energy needs of the region’s most vulnerable citizens.

State LIHEAP programs could stabilize heating fuel prices for low-income households and expand the reach of limited program funds if an agency could achieve

some form of price protection through contracting with retailers on a fixed or ceiling

price basis when heating oil prices are most attractive. Today, these ‘‘pre-buys’’ are

difficult to do, since the programs face the constraints of limited or no funds to carry

forward to a new heating season, and the new funds are not available until October

1 of each year. A federal appropriation, and advance funding, to the full authorized

level would allow states to manage the program resources in a manner to better

take advantage of retail contracts.

As you know, the fiscal year 2001 Labor, HHS and Education appropriations bill

did not contain advance fiscal year 2002 funds for LIHEAP. Enactment of advance

funding is vital to the states’ program planning activities for the coming heating

season. In the Northeast, where the heating season begins in early October, states

generally spend up to 70 percent of the LIHEAP funds during the first two quarters

of the fiscal year. States must be prepared to begin their LIHEAP program as soon

as the new fiscal year starts. Advance funding permits them to do this, even when

Congress has not yet enacted the Labor, HHS and Education appropriations bill for

the new fiscal year.

Our states have aggressively planned for a colder winter and higher heating fuel

prices. LIHEAP programs opened early and states undertook aggressive outreach

campaigns urging customers to conserve energy and explore fuel price protection options. States have designed their LIHEAP programs to make the most efficient use

of funds by coordinating with weatherization and leveraging programs. In cooperation with federal officials and the winter fuels industry, CONEG conducted a winter

fuels emergency simulation exercise to ensure that our states, federal agencies and

the industry will be prepared to anticipate and effectively manage winter fuel supply emergencies which may arise.

These preparedness activities, while critical, cannot fully shield our lowest-income

citizens from the impacts of higher heating fuel prices. Your support for increased

LIHEAP appropriations to the full authorized level and the enactment of advance

appropriations is urgently needed to enable our states to help mitigate the potential

life-threatening emergencies and economic hardship that confront the region’s most

vulnerable citizens.

We thank the Subcommittee for this opportunity to share the views of the Coalition of Northeastern Governors, and we stand ready to provide you with any additional information on the importance of the Low Income Home Energy Assistance

Program to the Northeast.
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PREPARED STATEMENT OF COLLEGE ON PROBLEMS OF DRUG DEPENDENCE, INC.

Thank you Mr. Chairman and Members of the Subcommittee for the opportunity

to present written testimony for the record. My name is Charles Schuster and in

addition to being a Professor of Psychiatry and Behavioral Neuroscience and Director of the Wayne State University Addiction Research Institute, I am the President

of the College on Problems of Drug Dependence (CPDD). The CPDD, formerly the

Committee on Problems of Drug Dependence, has been in existence since 1929 and

is the longest standing group in the United States addressing problems of drug dependence and abuse. From 1929 until 1976, the CPDD was associated with the National Academy of Sciences, National Research Council. Now the CPDD functions

as an independent organization with over 600 members representing all of the scientific disciplines and medical specialties concerned with understanding the etiology

and consequences of drug abuse and based upon this understanding the development of effective prevention and treatment interventions.

As part of its function the CPDD serves as an interface among governmental, industrial and academic communities maintaining liaisons with regulatory and research agencies as well as educational, treatment, and prevention facilities in the

drug abuse field. CPDD also serves as a collaborating center for the World Health

Organizations Drug Abuse Advisory Committee and members of the CPDD Board

of Directors have served as an Expert Advisory Group to the Office of National Drug

Control Policy.

Since 1938, a major focus of the CPDD’s activities has been its sponsorship of an

annual scientific meeting. This conference serves as a forum bringing together basic

scientists, clinical investigators from industry, academia, and government. Representatives of regulatory agencies and other policy makers, as well as scientists

and professionals in a number of diverse disciplines interested in the biochemical,

behavioral, and public health aspects of drug dependence participate. This year I am

pleased to note the Center for Substance Abuse Treatment/SAMSHA has supported

the participation of community treatment practitioners. This support will enable us

to bridge the gap between academic researchers and drug abuse treatment practitioners to facilitate the application of new science-based treatment and prevention

interventions in community treatment programs.

The National Institute on Drug Abuse/NIH is a governmental organization that

is very important to CPDD because it supports the overwhelming majority of the

scientific research on the biopsychosocial problems associated with drug abuse and

dependence. These research efforts are rapidly increasing our knowledge about the

etiology and consequences of drug abuse and providing a science base for the development of more effective prevention and treatment interventions. There are a number of areas of NIDA sponsored research ranging from the basic to the applied that

are making a difference. However, time permits me to mention only a few of these

today.

NEUROTOXICITY

Many years ago my colleagues and I at the University of Chicago reported that

high doses of methamphetamine (speed, crack) causes irreversible damage to

dopaminergic and serotonergic neurons in the brains of laboratory animals. Although this uniform finding across diverse-animal species suggests that similar effects would be found in humans it is important to firmly establish this conclusion.

Today, using modern techniques for the non-invasive study of the human brain

(Positron Emission Tomography, functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy) is allowing NIDA sponsored researchers to explore

this premise and definitive answers are imminent. In addition, NIDA sponsored research is currently using these imaging techniques to determine the type of brain

changes that take place when drug abusers are exposed to high doses of other drugs

such as cocaine, MDMA (Ecstasy) and heroin, whether these changes are irreversible and their functional consequences. The recent emergence of the problems of

teen-age abuse of MDMA and other ‘‘Club Drugs’’ exemplifies the ever-changing

challenges which face the NIDA.

BEHAVIORAL TREATMENT INTERVENTIONS

Such basic knowledge informs and improves efforts to develop treatments of drug

dependence. Treatments of all varieties and various combinations are important for

promoting abstinence for the drug abuser and dependent patients. Behavioral treatments are one area of many where NIDA has been very successful and effective in

adding to our ‘‘treatment toolbox’’. Behavioral treatments emphasize that treatment

must address multiple factors in an individual’s life that support drug use and rear-
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range them so that they support abstinence. Such successful treatments have shown

that teaching skills, supporting change, and providing incentives can produce both

immediate and long lasting abstinence in the drug-dependent patient. NIDA sponsored researchers are applying these important innovations to an ever increasing

array of conditions and patients. Among the most important of these is the pregnant

addict. Behavioral treatments that promote abstinence in pregnant mothers not only

help the mother, but prevent a plethora of problems in the developing baby. Such

efforts show the success of developing treatments and exemplify the broad impact

they can have not only today but also in tomorrow’s generation.

NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK (NIDA–CTN)

Developing successful treatments are important, but so is the dissemination and

utilization of those treatments. Over the past two years NIDA has established a network of 14 university-based research centers, each of which are affiliated with 5–

10 community treatment programs (CTP’s). Behavioral and pharmacological treatments, alone and in combination which have been shown to be efficacious in NIDA

sponsored controlled clinical trials will be evaluated for their ‘‘usefulness’’ in these

CTP’s. Those that are found to be useful will be disseminated to treatment programs throughout the United States. In this way the NIDA–CTN will facilitate the

utilization of the most effective treatments for all those seeking to overcome their

drug dependence problems. If funding is available, we understand that NIDA plans

on expanding this system to have an even greater impact on the quality of drug

abuse treatment available throughout the country. The College urges you to support

funding for NIDA at $991.7 million in the fiscal year 2002 Labor, Health and

Human Services Appropriation Bill, which represents a 27.0 percent increase over

current funding.

This increase will allow for the expansion of the CTN while at the same time providing the necessary funding for research which will lead to the development of new

treatment interventions that the CTN will evaluate.

The members of the College on Problems of Drug dependence want to thank this

Subcommittee for your steadfast support of the NIH in general and the National

Institute on Drug Abuse in particular. We believe that the federal governmental investment in drug abuse research is extremely wise. Every individual in this country

is effected either directly or indirectly by the problems associated with drug abuse.

Economists estimate that drug abuse costs our society over $100 billion dollars each

year. But dollars cannot portray the tragedies that drug abuse cause for the individual, their families and the communities in which they live.

I have seen the tragic consequences of my son’s involvement with the criminal justice system because of his illicit drug use. The good news is that research has shown

that drug abuse can be prevented and effectively treated. Clearly there is room for

improvement in our ability to prevent and treat the problems of drug abuse/dependence. This is why additional research is needed. Basic research to better delineate

the social and biological factors that make some young people vulnerable to the addictive properties of drugs of abuse. A thorough understanding of these etiological

risk factors for drug dependence will make it possible to improve our prevention efforts especially for those who are most vulnerable for addiction. Basic research is

essential for understanding what changes in the brain take place in the transition

from sporadic abuse of drugs to the compulsive use characterizing drug dependence.

This knowledge will help us to target the brain neurochemical systems that must

be treated with medications if we are to reverse the addiction process.

Finally, basic research is needed to delineate the long term neurotoxic consequences of exposure to drugs of abuse so that we can develop therapies to assist

individuals so afflicted to function optimally. Hopefully the insights provided by this

basic research will lead clinical researchers in the development of new effective

pharmacological and behavioral interventions for the treatment of all forms of substance abuse/dependence. Research has already shown that currently available empirically based prevention and treatment is the most cost-effective means of curbing

drug abuse. Clearly supporting research that will further improve our ability to prevent and treat the problems of drug abuse will pay handsome dividends both financially and for the morale of our country. CPDD therefore asks this Subcommittee

to seriously consider funding NIDA at $991.7 million for fiscal year 2002. We recognize that there are many competing demands for federal funds but strongly believe

that this area is of the highest priority.

It must also be stated that the membership of the College on Problem of Drug

Dependence is concerned about the adequacy of funding for drug abuse prevention

and treatment services. We therefore request that you provide increased funding for

the Center for Substance Abuse Prevention and the Center for Substance Abuse
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Treatment to insure that they are able to provide the support necessary to provide

all of our citizens the very best services possible.

Thank you for the opportunity to present the views of the membership of the College on Problems of Drug Dependence to this Subcommittee.

PREPARED STATEMENT OF COMMUNITY MEDICAL CENTERS, FRESNO, CA

Mr. Chairman and Members of the Subcommittee: My name is Dr. Philip Hinton

and I am Chief Executive Officer of Community Medical Centers in Fresno, California. Community Medical Centers is a not-for-profit, locally owned healthcare corporation that is committed to improving the health of the community. I am pleased

to provide the subcommittee with a request for assistance in securing federal monies

for a critical project in the Central San Joaquin Valley that would improve

healthcare delivery to the growing Hispanic and minority populations by creating

a network of clinics accessible to the rural areas. These populations in the five county area of Fresno, Madera, Tulare, Kings and Mariposa face some of the most devastating and worst health outcomes in the state of California and in the nation:

—the third highest asthma mortality rate in the nation;

—the highest rates of teen pregnancy in the state;

—the highest incidence of diabetes among the Hispanic population

—late or no prenatal care for pregnant women

—greater likelihood for newborns to be of low birth weight than the rest of the

state

—some of the lowest immunization rates in the nation (62 percent at age 2 versus

79 percent nationally)

—the highest rates of syphilis in the state.

These health outcomes are not acceptable and yet they exist because of the following reasons:

Limited access to care

—Low ratio of primary care providers to population. Fresno County has 178 physicians/100,000 population vs. 235/100,000 in the state.

—Virtually no specialist care located in rural areas

—Isolation of rural communities from urban areas and poor public transportation.

Financial constraints

—Many people are without health insurance

—Accessing healthcare in the urban areas results in a day’s lost wages

—Lack of childcare providers means that patients must bring their entire family

with them when they visit the clinic.

Educational issues concerning health

—Lack of understanding of preventive care

—Cultural barriers to addressing health issues before they become acute crisis

Language barriers

—Over 100 languages are spoken in the area

Coupled with high unemployment rates that are twice the state and three times

the national average, and adults and children living below the poverty line hovering

at 25 percent and 32 percent respectively, the statistics and indicators point to the

need for aggressive action to address the tremendous health care needs of the population in this five county area.

Community Medical Centers proposes to address this health situation with a pilot

project to improve the health of farm workers and residents of the rural communities who make up 41 percent of the population of the region.

Community Medical Centers has proposed developing a collaborative network that

will include local healthcare providers, Federally Qualified Health Centers, county

health and human services agencies, local hospitals, dentists, schools, churches and

local communities. The network will work to aggressively deliver both preventive

and primary health care to the people of the five county region. The new Regional

Health Center on the campus of the Regional Medical Center in downtown Fresno

will be the center for coordinating these activities. The new Regional Health Center

is just one component of a more comprehensive, $210 million medical complex that

will also include a new facility to house Level I burn and trauma services, emergency services, in-patient surgery, cardiac services and intensive care beds as well

as a University of California San Francisco (UCSF) Medical Education and Research

Center to house the teaching program. The Regional Health Center will deliver primary and specialty care, offer easy access to higher level care in an inpatient and
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outpatient setting, and access the faculty and residents of the UCSF-Fresno Medical

Education Program.

This $35 million project will:

—Improve access to the rural areas by partnering with existing centers and local

healthcare providers to provide access for all patients and utilize and coordinate

mobile health care units to go into the areas that are under-served. In addition,

provide trained bilingual personnel to qualify people for health care programs

and educate them about preventive care.

—Focus on preventive care and high prevalence diseases by offering asthma education and management programs; early diagnosis, dietary and medical management of diabetes; teen pregnancy prevention programs; prenatal care;

screenings for cancer, diabetes and high blood pressure; and dental and mental

health services.

—Result in a healthier community by providing primary care to a significant portion of the population and reducing their dependency on hospital emergency

rooms for these services; improve people’s quality of life and health thereby reducing hospital admissions for asthma, diabetes, hypertension and complications associated with these diseases; reduce the number of premature births.

—Realize significant savings in medical costs by focusing on the health needs of

the population and emphasizing prevention and disease management as opposed to depending on hospitalization for primary care. We predict a 20 percent

decrease in emergency room visits and hospitalization that would result in a

significant savings of $18 million per year.

The human statistics point to the need to address this situation now before it progresses to a crisis. Community Medical Centers is working with the County of Fresno to contribute $17.5 million of state and local monies toward this pilot project.

These monies, coupled with an additional $17.5 million from the federal government, would provide key funding support and ensure completion of this critical

health care initiative facing our community.

We have identified the HHS Health, Resources and Services Administration

(HRSA) Buildings and Facilities earmark in the fiscal year 2002 appropriation bill

for Labor/HHS/Education as a source of funds. We understand that this program is

specifically designated for buildings and facilities, and we request your assistance

in securing as much of the needed $17.5 million as possible through this program

account for the Regional Health Center to be housed on the downtown campus in

Fresno. This past year, we were pleased to be the recipients of $851,000 of Federal

support for this project. The funding was provided by the fiscal year 2001 Department of Health and Human Services Appropriation Act (Public Law 106–554).

We appreciate your attention to this matter, and we hope that you will favorably

consider our request to improve healthcare delivery to the Central San Joaquin Valley in California.

PREPARED STATEMENT OF THE COUNCIL OF STATE AND TERRITORIAL

EPIDEMIOLOGISTS

FULL FUNDING FOR THE PUBLIC HEALTH THREATS AND EMERGENCIES ACT

The Public Health Threats and Emergencies Act (PHTEA) is landmark legislation

that was signed into law on November 13, 2000. The PHTEA builds on three years

of funding, provided by Congress, to prepare the nation for bioterrorist attacks by

strengthening the nation’s public health system at the local, state and federal level.

The PHTEA was introduced after a series of bipartisan Congressional forums, Committee hearings and a GAO report all of which established that our public health

system is not prepared to detect or respond effectively to significant public health

threats, including major outbreaks of infectious disease, pathogens resistant to antimicrobial agents, and acts of bioterrorism. CSTE contributed to the development of

the PHTEA at every phase, and strongly supports funding the Act at the authorized

level of $534 million.

The PHTEA has four major components as follows: (1) $100 million for building

public health capacity with this amount expected to rise in future years; (2) $40 million for antimicrobial resistance; (3) $215 million for Bioterrorism preparedness; and

(4) $180 million for CDC’s facilities renovations. I will focus commentary on two

components, building public health capacity and bioterrorism preparedness.

Building Public Health Capacity by Strengthening Infrastructure.—The Public

Health Capacities provision of PHTEA has three main sections. Section 319A requires the Secretary of HHS, by November, 2001, to establish reasonable capacities,

including needed personnel or workforce, that are appropriate for effective response
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to major public health threats. These capacities would include, for instance, the ability of a state or local health department to: recognize the clinical signs and epidemiological signs of significant outbreaks of infectious disease; identify the diseasecausing pathogens rapidly; organize and implement an effective medical response

for those infected and prevention measures for those in danger of exposure; and

communicate relevant information about the threat rapidly to other health departments, the CDC and to the provider community. Section 319B requires the Secretary, by November, 2001, to award grants to states to perform an evaluation of

the extent to which state and local health departments can achieve the needed capacities. Finally, Section 319C provides grants to state and local health departments

to address the identified gaps in their capacities—again with a focus on building capacity to identify, detect, monitor and respond to threats to the public health. Funds

for filling gaps in capacities can be used to train public health personnel; develop,

enhance, coordinate or improve participation in an electronic network for rapid disease information dissemination; develop plans for responding to public health emergencies coordinated with all levels of government; and enhance laboratory capacity

and facilities.

Part of public health capacity building reflects CSTE’s efforts, since 1994, to develop a comprehensive, state-based National Public Health Surveillance System

(NPHSS). Congress has begun to support components of this system through the

Health Alert Network (HAN) and the National Electronic Disease Surveillance System (NEDSS). However, there are other components that address the need for flexible, coordinated, and efficient surveillance (or health tracking) systems and that define the methods of surveillance in a changing health environment. These issues are

discussed more thoroughly in the NPHSS section below.

Bioterrorism Preparedness.—For the past three years, Congress has provided

funding specifically to address the greatest public health threat of all—bioterrorism.

The PHTEA provides a more coherent framework for addressing this very real

threat, one that experts believe will happen, it is just a matter of when. Some national security officials believe the United States will experience a major bioterrorist

incident within the current decade.

The PHTEA ensures federal coordination of bioterrorism preparedness by creating

interdepartmental task forces and working groups. Grants are made available to

state and local health departments, but also to hospitals, clinics and primary care

facilities, for the following purposes: (a) training of health care professionals and

public health personnel to recognize the symptoms and epidemiological characteristics of exposure to a potential bioweapon; (b) rapid and accurate identification of potential bioweapons; (c) coordinating medical care for individuals exposed to bioweapons; (d) facilitating and coordinating rapid communication of data generated

from a bioterrorist attack between national, state, and local health agencies and

health care providers.

BUILDING THE NATIONAL PUBLIC HEALTH SURVEILLANCE SYSTEM

Epidemiologists working in public health agencies are responsible for monitoring

trends in health and devising prevention programs that enable the entire community to be healthy. The science of epidemiology and surveillance, or health tracking,

provide the basis for appropriate public health practice. Public health assessment

includes surveillance, epidemiologic studies, program monitoring of diseases, risk

factors for disease, health hazards, and preventive actions. Surveillance enables

public health officials to:

—Recognize outbreaks and intervene to prevent additional cases;

—Identify priority health problems/needs so that resources can be appropriately

allocated;

—Identify high-risk communities and groups to effectively target programs;

—Monitor the effectiveness of public health programs; and

—Identify issues that need further scientific study to devise preventive strategies.

These core activities of public health agencies are critical to the success of public

health efforts, but have historically had no stable funding source and are often the

first to suffer in state funding cutbacks. Funding restrictions in categorical federal

programs have also contributed to a fragmented approach to surveillance at the

state and local level. CSTE recommends that all federal funding for public health

programs recognize and adequately fund epidemiology, assessment and surveillance

as core required activities for public health programs. States should also be given

flexibility to combine and integrate categorical funds for this purpose. This will help

build the National Public Health Surveillance System (NPHSS) which CSTE conceptualized and has been advocating for among its various local, state, and federal

partners.
535

In addition to support for core public health surveillance, CSTE supports the establishment of a national electronic public health surveillance, or health tracking,

system that encompasses development of standards and criteria from which all programmatic surveillance systems would be built. CSTE views this overarching electronic system (NEDSS) as an important component of a National Public Health Surveillance System. Several CDC programs have well-developed surveillance systems

that meet the needs of the program, but are not easily linked to increase the body

of knowledge of the public’s health. There is critical need for an over-arching model

for integrated public health surveillance that assumes collaboration and integration

of data collection efforts and use of surveillance resources across program and Center lines both at the federal and state levels. More effective integration of surveillance and health information systems could increase the power of public health

agencies to make effective use of available information as economically as possible.

In practical terms, an integrated health tracking system allows the detection and

monitoring of infectious disease outbreaks and environmental hazards that involve

more than one local or state jurisdiction such as the recent West Nile Fever outbreak.

Most importantly, a comprehensive, integrated, electronic surveillance, or health

tracking, system present in every state and operational at the local, state and national level is the nation’s best defense against a serious bioterrorism threat. It is

a critical component of public health infrastructure that will significantly strengthen

core public health capacity.

For the past two years, Congress has provided specific resources to begin implementing the National Electronic Disease Surveillance, or Health Tracking, System

(NEDSS). In fiscal year 2000, $20 million was provided for this project at CDC and,

in fiscal year 2001, $35 million, but since $5 million of this was earmarked for specific projects only $30 million was provided to CDC to continue building NEDSS nationally. Currently, under the fiscal year 2000 extramural grants, the first round to

date, all 50 states have received some NEDSS funding with 42 states receiving Assessment and Planning grants averaging $86,000; 12 states receiving Element Development grants averaging $315,000 and two states, New York and Oregon, receiving Charter Site grants averaging $1,113,000 each. It is important to note that fully

35 states applied for Element Development grants, which include features such as

web browser-based data entry, HL 7 messaging, and integrated data repository, but

in large part due to resource constraints, only 12 received funding. Similarly, CDC

received 12 Charter Site applications, but only had resources to fund two. Clearly

more resources are needed to help states build a national electronic health tracking

system. CSTE strongly supports $50 million in fiscal year 2002 for the NEDSS

project as a critical public health capacity building component as provided within

the Public Health Threats and Emergencies Act.

INCREASED SUPPORT FOR STATE CONDUCTED HIV CASE SURVEILLANCE, OR TRACKING

HIV case surveillance, or tracking, is a critical defense against the spread of

AIDS, but currently depends on under-funded state and local health departments

where funding for on-going AIDS surveillance (tracking) has been level or declining

for several years. CDC estimates 200,000 250,000 persons are living with HIV (not

AIDS) in non-HIV reporting states. Several recent developments have intensified

the need for increased support for state and local health departments to conduct appropriate HIV case surveillance: (1) in December, 1999, CDC issued HIV case surveillance guidelines, but no additional funds were provided to states despite the fact

that HIV case surveillance costs twice as much as AIDS surveillance; (2) the newly

re-authorized Ryan White CARE Act (Public Law 106–345) includes new provisions

that that seek to include HIV data in the formula that determines how many Federal resources each state will receive; (3) the September, 2000 Institute of Medicine

report, ‘‘No Time To Lose: Getting More from HIV Prevention,’’ recommended that

sentinel surveillance also be expanded to provide additional information on HIV incidence. None of these important recommendations and developments can be responded to without additional resources for states.

For the 2000 and 2001 grant cycle for state cooperative agreements with CDC to

conduct HIV surveillance, states requested twice the amount than they were awarded—a 40 percent gap in funding at a time when the need for HIV case surveillance

data is intensifying and its benefit as a tool to target prevention efforts and reduce

transmission of the disease is clear. CSTE strongly supports a $45 million increase

in fiscal year 2002 to strengthen state and local health department HIV surveillance

(tracking) systems.
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ADDRESSING IDENTIFIED STATE AND LOCAL ENVIRONMENTAL HEALTH CAPACITY

DEFICIENCIES

CSTE concurs with the Pew Environmental Health Commission’s findings and

supports their recommendations to commit significant national resources to enhance

the National Public Health Surveillance System (NPHSS) so that, in addition to the

ongoing efforts to monitor infectious diseases, the public health community can

begin to track all chronic diseases and conditions like asthma, birth defects, and

various forms of cancer. To advance the understanding of environmental disease,

the NPHSS needs to include an ability to investigate disease links to environmental

exposures. Much of the NPHSS will need to be based in state and local health departments where the data is generated, but allow aggregation for national assessment of progress toward the 2010 Healthy People goals. However, a comprehensive

data system is not enough. Sufficient public health expertise capacity must also be

present to interpret data, evaluate environmental health problems, and advance solutions. Both data collection and timely local response are a fundamental duty of

state government, but experience has shown value-added benefits from federal partnerships. The scope of environmental public health activities is broad, ranging from

assurance of the quality and integrity of public food, water and waste disposal systems to protecting the environment from manmade pollutants.

As a down payment on implementation of a nationwide health tracking system

which will include chronic disease and its link to environmental exposures, CSTE

urges Congress to provide an additional $20 million in fiscal year 2002 to expand

environmental health capabilities within state health departments. Two agencies

provide the bulk of the federal support for state environmental public health: the

Agency for Toxic Substances and Disease Registry (ATSDR) and the National Center for Environmental Health (NCEH); both are administered by CDC. The Pew

Commission has called for merging ATSDR and the NCEH under HHS at the CDC.

ATSDR provided nearly $9 million in fiscal year 2001 to 28 states to assess environmental threats to communities. This program focus needs additional funding to

reach all states, and provide each state with sufficient support.

The NCEH has been unable to provide core support for state environmental public

health, but does provide substantial technical and laboratory assistance and categorical support to address issues such as childhood lead poisoning and emerging environmental threats such as asthma. CSTE urges the Subcommittee to increase support for CDC’s asthma program from its current funding level of $25 million to $50

million. In spite of significant advances in the diagnosis and treatment of asthma,

an improved understanding of the environmental triggers of asthma attacks, the

health burden of asthma in the United States is increasing at epidemic proportions.

Asthma affects more than 14 million Americans, of which five million are children.

Over 5000 persons died from asthma in 1995, and asthma accounts for nearly

500,000 hospitalizations each year. The health care costs associated with asthma exceeded six billion dollars in 1990, and is currently $11 billion. Experts predict that

those costs could climb to more than $18 billion by the year 2020.

Asthma control and prevention requires a long term, multifaceted approach that

includes patient education, surveillance, and control programs. These programs

have not been available due to a lack of resources at the state level. CDC’s asthma

program needs increased funding.

RESTORING AND INCREASING FUNDING FOR THE PREVENTIVE HEALTH/HEALTH SERVICES

BLOCK GRANT

This program was cut $15 million in fiscal year 2000, a ten percent reduction, and

level funded in fiscal year 2001. State health officials have indicated that $210 million is needed to enable them to respond to identified health problems that gaps in

discretionary program funding prevent them from addressing, and unexpected

health crises, such as West Nile Virus, or an environmental hazard. The PHHS

Block Grant provides the only source of flexible funding for state health departments to address health problems they have specifically targeted under Healthy

People 2010 goals, such as cardiovascular diseases and injury, but do not have sufficient, or sufficiently flexible, discretionary funds, to reach specified goals. In addition, up to five percent of total Prevention Block Grant funding is used to support

basic public health activities including routine epidemiological surveillance, or

health tracking. It seems contradictory to the public health community to support

bioterrorism preparedness including building epidemiological capacity in state and

local health departments and then threaten the net positive effect of this support

by cutting the block grant funding ten percent and then locking in the cut through

level funding.
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SUPPORT FOR THE BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM

The Behavioral Risk Factor Surveillance System (BRFSS) is an essential component of an overarching public health surveillance, or tracking, system. It the only

source of state level behavioral data, but is used at every level of government to

inform intervention programs, policy decisions and budget direction for chronic and

other diseases. It is the source of data for 24 of the 73 chronic disease indicators,

six areas of the Healthy People 2010 leading health indicators and serves as the

core source of surveillance, or health tracking, for multiple public health programs

across the entire CDC. The BRFSS is currently in its 17th year of operation and

is the largest continuous telephone survey in the world. It is flexible, timely and

allows for state-to-state and state-to-nation comparisons of data. The BRFSS is able

to address emerging health issues and fewer resources are required to run BRFSS

than is required to run in-person interviews. The state-based telephone surveys are

used to monitor health behaviors and knowledge regarding tobacco use, physical inactivity, poor diet, alcohol use, violence, risky sexual behaviors, and lack of preventive services (i.e. screening and immunizations).

In spite of all the data that BRFSS provides and the role these data play in the

development of intervention programs and policy decisions, CDC funding for BRFSS

is discretionary and averages $62,000 per state. Although states support a majority

of the costs of BRFSS data collection, few are able to analyze and translate the data

into long-term disease prevention and control programs and policies due to a lack

of resources.

Current funding for BRFSS is $1.9 million. CSTE believes that BRFSS should be

a discrete line item in the CDC budget and that funding should be doubled to $3.8

million in fiscal year 2002 to ensure adequate funding for all states.

The Council of State and Territorial Epidemiologists appreciates the opportunity

to provide its fiscal year 2002 funding recommendations to the Subcommittee. Our

members look forward to working with the Subcommittee to strengthen these areas

of public health activity that CSTE believes are so critical to enhancing and protecting the health of the American public.

PREPARED STATEMENT OF THE CROHN’S AND COLITIS FOUNDATION OF AMERICA

INTRODUCTION

Mr. Chairman, thank you for the opportunity to submit testimony on behalf of the

Crohn’s & Colitis Foundation of America (CCFA). CCFA is a non-profit, voluntary

organization dedicated to finding the cure for Crohn’s disease and ulcerative colitis.

Throughout its 34 year history, CCFA has sponsored basic and clinical research of

the highest quality. The Foundation also offers a wide range of educational programs for patients and healthcare professionals, and provides support services to assist people in coping with these chronic intestinal diseases.

My name is Jean Kouris, I live in Berea, Ohio, a suburb of Cleveland, and I am

honored to represent the people of this country who suffer from Crohn’s disease and

ulcerative colitis. These are serious diseases that affect the gastrointestinal (GI)

tract. Because they behave similarly, Crohn’s and colitis are known as inflammatory

bowel disease, or IBD. They can cause severe diarrhea, cramping abdominal pain,

fever, and rectal bleeding. Complications of IBD can include arthritis, osteoporosis,

anemia, liver disease, and colon cancer. Crohn’s and colitis are not fatal, but they

can be devastating. We do not know their cause, and we have no cure.

I am all too familiar with these diseases because my son Nathan is one of the

up to one million Americans who suffer from IBD. Nathan has the dubious distinction of being among the youngest of children diagnosed with Crohn’s disease. And

while his age at diagnosis is unusual, the manifestation and course of the disease

itself has not been. His nine short years have been a study in endurance, determination, the healing power of medicine and the healing power of prayer.

When Nathan was about seven weeks old, I arrived to pick him up at the end

of a workday. The sitter told me that he had cried inconsolably for most of the day,

drawing his legs up as if he was in pain. ‘‘There’s something wrong with your baby,’’

she said. The dutiful first-time mother, I took him to see the pediatrician that

evening. Admittedly he was smiling and happy on my lap in her office, and her explanation was that some babies just had a harder time separating from their mothers when they went back to work.

Shortly thereafter, when he started passing bloody stools, I was told this was fairly common, and to put him on a ‘‘lactose-free’’ diet. By age six months he had been

referred to a pediatric gastroenterologist, who put him on medication and scheduled
538

him for a colonoscopy. When the biopsy results came back I was told that he had

something ‘‘not usually seen in babies this age.’’

Over the next few months Nathan’s condition continued to deteriorate, and I became increasingly disenchanted with this particular physician. I first saw the words

Crohn’s disease when I picked up Nathan’s biopsy results to take to another doctor

for a second opinion. While waiting for the day of the appointment, Nathan, who

was now eleven months old and otherwise developing normally, became so weak he

could not stand up.

Three months later Nathan was put on ‘‘total parenteral nutrition’’ (TPN). TPN

is a special liquid food mixture administered intravenously. Around this time, I remember saying to the doctor ‘‘I’m afraid he’s going to die,’’ and she responded ‘‘I’m

not saying he won’t, but right now we’re a million miles away from that.’’ That was

the right thing for her to say to me as a mother, but I learned later that she had

cried privately, afraid too that he would not make it.

For the next nine months I kept a bag packed, at the ready to head for the hospital if one of his twice-daily temperature readings was elevated. That was a trip

I made too many times to count, as Nathan spent more than 90 days in the hospital

during that time.

We have endured the comments of unknowing strangers, like the woman who referred to him as ‘‘a baby on a leash’’ and one who scolded my husband for ‘‘overfeeding that poor child.’’ The reality was that he was seriously malnourished, but

so bloated from the TPN and steroids that his eyes had become mere slits.

I took pictures, as every baby book should have the full complement of about a

million and a half photos before age two. I took pictures of Nathan in the hospital,

Nathan with his favorite nurses, Nathan pulling the TPN pack in a little red wagon,

Nathan bare-chested with the Broviac showing. I took pictures because he was a

charming child, always smiling and happy, a fun-loving baby who effervesced with

a joy for life.

Nathan is nine now. He has achieved a measure of medical stability, and last

summer, for the first time in his life, he actually went three months between doctor

visits! He plays baseball and football, and takes piano and horseback riding lessons.

He collects Poke-mon and does all the things most nine-year-old kids do.

I know that throughout his life he will have good times and not so good times.

But Nathan has the spirit of a warrior and that’s what helps him get through the

difficult days. I also know that a cure is possible. I envision a world without Crohn’s

disease and ulcerative colitis. I hope you do too.

If we are to find the cause of, and cure for IBD, we must investigate all of the

exciting possibilities that are being made known to us. To take advantage of these

opportunities, CCFA has developed long-standing partnerships with NIH—specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

and the National Institute of Allergy and Infectious Diseases (NIAID)—and the Centers for Disease Control and Prevention (CDC).

RECOMMENDATIONS FOR FISCAL YEAR 2002

NATIONAL INSTITUTES OF HEALTH

Mr Chairman, together with NIAID, NIDDK supports the majority of IBD research at NIH. We were pleased that the Committee again last year recognized

CCFA’s IBD research agenda, entitled ‘‘Challenges in Inflammatory Bowel Disease,’’

in its report.

Although we have made significant progress in recent years in the fight against

Crohn’s disease and ulcerative colitis, IBD remains among the most challenging disorders affecting the digestive tract. IBD patients and their families are pinning their

hopes for a better life on medical advancements made through NIH and CCFA sponsored research. For this reason, CCFA supports the goal of the doubling the NIH

budget by fiscal year 2002 and joins with the Ad Hoc Group for Medical Research

Funding in recommending a 16.5 percent increase for NIDDK, NIAID, and NIH

overall in fiscal year 2002. Moreover, the CCFA encourages the subcommittee to increase IBD research funding within NIDDK and NIAID at the same rate as NIH

overall.

Throughout its 30-year existence, CCFA has recognized the importance of working

closely with NIH. A primary principal of the Foundation’s research program is to

provide investigators with seed money to generate enough preliminary data to compete for NIH grants. And indeed, at last count, 40 of 57 IBD researchers funded

through NIDDK and NIAID were former CCFA grant recipients.

Some of the most promising IBD research by the NIH has focused on translating

findings from studies conducted on animal models to humans with IBD. These animal models have enabled researchers to form the current hypothesis that Crohn’s
539

disease and ulcerative colitis are caused by a malfunctioning immune system,

wherein components of the patient’s immune system overreact to normal intestinal

bacteria.

We know that people are susceptible to this malfunction because of their genetic

makeup but further research is necessary to determine which bacteria are responsible, how these bacteria interact with the intestine’s immune system, and which

immune system components are involved.

Mr. Chairman, I am pleased to report that due in part to CCFA’s Basic Research

Agenda and our partnerships with NIDDK and NIAID, research findings are being

translated with greater speed into new therapies for IBD patients. According to an

industry report, the total sales of pharmacological therapies to treat IBD is expected

to increase to nearly $1 billion in 2008, and the most dramatic increase will be in

the sale of biologic therapies that target various proteins in the immune system.

By working together we have begun to alleviate the intense pain suffered by people with IBD, but there is a great deal more that needs to be accomplished. Our

progress thus far gives us tremendous hope for the future, however, the study of

new and promising research pathways depends upon increased federal funding for

IBD research at NIH.

Finally, CCFA is excited by NIDDK’s recent announcement that Dr. Stephen

James, a leading IBD researcher, has joined the institute as the deputy director of

its Digestive Diseases and Nutrition Division. We look forward to working with Dr.

James in the search for improved clinical therapies, and a cure for IBD.

CENTERS FOR DISEASE CONTROL AND PREVENTION

IBD Surveillance Program

Mr. Chairman, as I have mentioned previously, CCFA estimates that ‘‘up to one

million’’ people in the United States suffer from IBD. Unfortunately, we do not have

an exact number: Due to the complicated nature of these diseases, patients may remain undiagnosed or misdiagnosed for several years. Given the recent advancements in treatment for these diseases and the increased risk that IBD patients have

for developing colorectal cancer, CCFA is pleased that the Committee again last

year recommended that CDC initiate a nationwide surveillance and epidemiological

program with respect to IBD.

CCFA believes that generating improved epidemiological information on the IBD

population is essential if we are to provide our patient community with the best possible care. We look forward to working with CDC this year on a comprehensive IBD

epidemiological program. We ask that the subcommittee continue to support this important initiative in fiscal year 2002.

Colorectal Cancer Prevention

Finally, Mr. Chairman, in addition to coping with either Crohn’s disease or ulcerative colitis, many IBD patients are at high risk for developing colorectal cancer. As

you may know, colorectal cancer is the third most commonly diagnosed cancer for

both men and women in the United States and the second leading cause of cancerrelated deaths. Because people who have suffered from IBD for more than eight

years are susceptible to this disease, CCFA has a long history of actively promoting

the benefits of colorectal cancer screening.

Although colorectal cancer is almost entirely curable when detected early, studies

have shown a tremendous need to: (1) inform the public about the availability and

advisability of screening and (2) educate healthcare providers about screening guidelines. CDC’s National Colorectal Cancer Roundtable is actively working to address

these challenges by partnering with organizations like CCFA to implement a national public awareness campaign emphasizing the importance of screening and

early detection. CCFA encourages the subcommittee to provide CDC with $15 million in fiscal year 2002 (an increase of $6 million over fiscal year 2001) for this vital

campaign.

IBD RESEARCH AND SURVEILLANCE COORDINATING COMMITTEE

Mr. Chairman, because NIH and CDC are engaged in numerous research and

public health activities related to IBD, CCFA recommends that the Department of

Health and Human Services establish an Inflammatory Bowel Disease Research and

Surveillance Coordinating Committee to ensure that the Federal government has a

focused and coordinated plan for addressing IBD.

CCFA recommends that the Coordinating Committee be comprised of representatives from NIDDK, NIAID, the National Institute of Child Health and Human Development, CDC and other Public Health Service agencies as appropriate. The Committee would be charged with developing and implementing a comprehensive IBD
540

strategy in collaboration with the IBD community. We ask that the subcommittee

join us in supporting the establishment of a Coordinating Committee in fiscal year

2002.

Mr. Chairman, thank you for the opportunity to present the views of the Crohn’s

and Colitis Foundation of America.

PREPARED STATEMENT OF THE CURE FOR LYMPHOMA FOUNDATION

INTRODUCTION

It is my pleasure to submit this statement regarding funding for the National Institutes of Health (NIH) in fiscal year 2002 and priorities for lymphoma research.

I am a volunteer representing the Cure For Lymphoma Foundation (CFL), a nonprofit organization that funds research on Hodgkin’s disease and Non-Hodgkin’s

lymphoma (NHL); provides educational materials and support services to individuals with lymphoma and their families; and engages in advocacy activities to advance a cure and improve the quality of care for those with lymphoma.

In November 1997, two weeks before my 38th birthday, I was diagnosed with follicular non-Hodgkin’s lymphoma, an indolent cancer with a life-expectancy of seven

to ten years. At that time, I was advised that because this disease was incurable,

the best treatment strategy would be to ‘‘watch and wait’’ or defer treatment until

I experienced further progression of my disease. As the mother of two young children, receiving this diagnosis and treatment recommendation certainly sharpened

my focus on the disease and the advances in the treatment of lymphoma. During

the next two years, I became involved in the activities of CFL and became an amateur researcher monitoring each and every advancement in lymphoma research and

treatment. I felt one of my strongest contributions to CFL could be participating in

public policy activities, attempting at every opportunity to create the very best climate for lymphoma research.

By November of 1999, my disease had progressed to the point where treatment

became necessary and I participated in a clinical trial of a vaccine for the treatment

of lymphoma but achieved only a brief remission. Currently, I am preparing to enroll in a second clinical trial, this time hoping to secure a longer remission through

a combination therapy using monoclonal antibodies. It is my hope, in this statement, to convey both the exciting opportunities for lymphoma research and the

sense of urgency that must be brought to this research and its funding. Those of

us living with lymphoma will accept no less.

INCIDENCE OF LYMPHOMA

The Director of the National Cancer Institute (NCI) proudly reported this year

that the incidence of most cancers is declining. This achievement is to be applauded.

However, the situation for lymphoma is different. Since the 1970’s, incidence rates

for NHL have increased dramatically, making it one of the fastest rising cancers in

the United States. The number of persons diagnosed with NHL has doubled since

the 1970’s, and NHL is the second rising cancer in incidence and death rates in the

United States. The reasons for the increased incidence of NHL are not understood.

This is a matter that deserves more attention, and CFL recommends a coordinated

and aggressive research enterprise directed toward strengthening our understanding of the reasons for the increase in incidence of lymphoma.

LYMPHOMA RESEARCH ADVANCES AND OPPORTUNITIES

The nation’s investment in basic research has deepened our understanding of

lymphoma and contributed to enhancements in treatment, with many more therapeutic improvements expected. These advances include:

—Use of genetic analysis techniques to identify subpopulations of lymphoma patients who respond more favorably to chemotherapy. NCI-sponsored researchers

have developed a lymphochip, which utilizes microarray technology and has allowed researchers to identify two subtypes of B-cell lymphoma. This discovery

has significant implications, because further development and commercialization of the lymphochip will allow physicians to accurately diagnose patients and

predict whether they may be effectively treated with chemotherapy or not, depending on their lymphoma subtype.

—Advances in immunology that have led to the development of a monoclonal antibody for the treatment of indolent B-cell NHL and may be the first of a group

of therapies that use the body’s own immune system to fight cancer.

—Cancer vaccines that employ immunotherapy to rally the body’s defense against

the diseases are currently being tested in trials across the country.
541

—New therapies combining different modalities, such as immune therapy and radiation, to fight the disease.

PROGRESS REVIEW GROUP ON LEUKEMIA, LYMPHOMA, AND MYELOMA

The NCI recently convened a meeting of extramural scientists, physicians, and advocates in a Leukemia, Lymphoma, and Myeloma Progress Review Group (LLM–

PRG) that analyzed the current NCI portfolio of research on blood-related cancers

and opportunities and barriers to research on these cancers. The report of the LLM–

PRG is not yet complete, but a preliminary draft summarizing the work of the advisory panel captures the wealth of research opportunities that are available to researchers on blood-related cancers and identifies strategies for capitalizing on all

those research avenues. We believe the unique contribution of the LLM–PRG may

be proposals for innovative cooperative public-private sector research and development endeavors, and we applaud the willingness of the group to consider aggressive

research strategies and structures.

Because advances in the treatment of blood-related cancers often provide insights

into the treatment of all other cancers, the LLM–PRG report should be of particular

importance not only to NCI but also to the Congress.

FISCAL YEAR 2002 RECOMMENDATIONS FROM CFL

CFL believes this is a critically important moment in lymphoma research which

must be maximized by an appropriate federal response. CFL recommendations are

listed below.

—Congress should sustain progress toward doubling the NIH budget in the fiveyear period from fiscal year 1999 to fiscal year 2003. We applaud the commitment of the Congress in providing substantial increases in funding for NIH in

fiscal year 1999, 2000, and 2001 and urge that you provide an increase of 16.5

percent in fiscal year 2002. A boost of this magnitude is necessary to ensure

that the five-year goal can be met.

—The Subcommittee should include language in its report that requires NCI to

respond to the recommendations of the LLM–PRG when it appears before the

Subcommittee to defend its fiscal year 2003 budget. CFL believes the LLM–PRG

report may make a special contribution in identifying opportunities for publicprivate sector cooperation, and NCI should be directed to pay particular attention to these recommendations and its ability to implement collaborative programs of this sort.

—The Subcommittee should also include language in its report that requires NCI

and the National Institute of Environmental Health Sciences to coordinate their

investigations of the possible links between environmental exposures to toxins

and the development of lymphoma.

—The Centers for Disease Control and Prevention (CDC) should be directed to

enter into discussions with lymphoma researchers regarding the collection of

lymphoma incidence and survival data through the CDC cancer registries program. In order to aid the lymphoma research effort, CDC cancer registries

should collect lymphoma data by subtype.

PREPARED STATEMENT OF THE DIGESTIVE DISEASE NATIONAL COALITION

Mr. Chairman, thank you for the opportunity to submit testimony regarding fiscal

year 2002 appropriations for the National Institutes of Health and the Centers for

Disease Control and Prevention. before you today. I am Dr. Maurice Cerulli, a practicing gastroenterologist and Chief of Gastroenterology at The Brooklyn Hospital

Center and president of the Digestive Disease National Coalition (DDNC). Founded

in 1978, the DDNC is a voluntary organization comprised of 25 professional and patient organizations concerned with the many disease of the digestive tract. The Coalition has as its goal a desire to improve the health of the millions of Americans

suffering from both acute and chronic digestive disorders.

Mr. Chairman, the social and economic impact of digestive disease is enormous.

Digestive disorders afflict approximately 62 million Americans, resulting in 50 million visits to physicians, 10 million hospitalization, 230 million days of restricted activity, and nearly 200, deaths annually. The total cost associated with digestive diseases has been conservatively estimated at $60 billion a year.

On behalf of the DDNC, I would like to thank the subcommittee for its past support of digestive disease research and prevention programs at the NIH and CDC.

With respect to the coming fiscal year, the DDNC joins the Ad Hoc Group for Medical Research Funding in recommending a 16.5 percent increase for the National In-
542

stitute of Diabetes and Digestive and Kidney Disease (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID) and the NIH overall. These increases will keep on track, for the final 2 years, the initiative to double the NIH

budget over a 5 year period.

SPECIFIC RECOMMENDATIONS FOR FISCAL YEAR 2002

Inflammatory Bowel Disease.—Up to one million people in the United States suffer from Crohn’s disease and ulcerative colitis, collectively known as inflammatory

bowel disease (IBD). These are serious diseases that affect the gastrointestinal tract

causing bleeding, diarrhea, abdominal pain and fever. Complications of IBD can include anemia, ulcers of the skin, eye disease, colon cancer, liver disease, arthritis,

and osteoporosis. Crohn’s disease and ulcerative colitis are not usually fatal, but

they can be devastating. We do not know the cause, and we have no cure.

In recent years we have made significant progress in the fight against IBD. In

1998, the FDA approved the first drug ever specifically for Crohn’s disease. The

DDNC encourages the subcommittee to continue its support of IBD research at

NIDDK and NIAID at a level commensurate with the overall increase for each institute.

Given the recent advancements in treatment for these diseases and the increased

risk that IBD patients have for developing colorectal cancer, the DDNC believes

that generating improved epidemiological information on the IBD population is essential if we are to provide patients with the best possible care. Therefore, the

DDNC, and its member organization the Crohn’s and Colitis Foundation of America,

encourage the CDC to initiate a nationwide IBD surveillance and epidemiological

program in fiscal year 2002.

Endoscopic Research.—There continues to be tremendous potential for the development of new diagnostic and therapeutic procedures for gastrointestinal disorders.

Without surgery, using endoscopes, we can find bleeding ulcers and stop the bleeding; we can take out stones that are blocking the bile duct; and we can cut out colon

polyps to prevent colorectal cancer. The Clinical Outcomes Research Initiative

(CORI) program is allowing us to link more than 50 centers around the country to

assess the outcomes of endoscopic therapies. The gastroenterology community looks

forward to working with the NIDDK to expand its endoscopic research program and

we encourage the subcommittee to support this important effort.

Hepatitis C: a Looming Threat to Health.—It is estimated that 4 million Americans are infected with the Hepatitis C Virus (HCV). Unfortunately the majority of

infected individuals are unaware that they have contracted the disease. In 1997,

more than 10,000 people died from hepatitis C and the CDC estimates that the

death rate will triple by 2010 unless there is additional research, education and effective public healthy interventions. Moreover, liver failure from HCV now accounts

for more than half of all the liver transplants performed in the United States and

is the leading cause of liver cancer.

The DDNC joins with the liver disease community in recommending an increase

of $15 million in fiscal year 2002 for CDC’s Hepatitis C Prevention Strategy program. This new funding will expand the number of states with CDC sponsored hepatitis C prevention coordinators from 16 to 50. In addition, we recommend an appropriation of $40 million (an increase of $17 million over fiscal year 2001) for CDC’s

Prevention Research Centers program.

Finally, Surgeon General David Satcher drafted a ‘‘Dear Citizen’’ letter last year

warning American about the silent epidemic of HCV. The letter provided important

educational information on HCV as well as action people can take to determine

whether or not they are infected. The DDNC encourages the subcommittee to work

with the Surgeon General’s office in fiscal year 2002 to facilitate the distribution of

this important correspondence to all Americans.

Pancreatic Cancer.—Last year, an estimated 28,300 in the United States were

found to have pancreatic cancer and approximately 28, 200 died from the disease.

Pancreatic cancer is the fourth leading cause of cancer death in men and women.

Only 2 out of 10 patients will live one year after the cancer is found and only a

very few will survive five years. Although we do not know exactly what causes pancreatic cancer, several risk factors linked to the disease have been identified:

—Age: Most people are over 60 years old when the cancer is found;

—Sex: Men have pancreatic cancer more often than women;

—Race: African Americans are more likely to develop pancreatic cancer than are

white or Asian Americans;

—Smoking

—Diet: Increased red meat and fats

—Diabetes
543

The National Cancer Institute has established a Pancreatic Cancer Progress Review Group charged with developing a detailed research agenda for the disease. The

DDNC encourages the subcommittee to provide an increase for pancreatic cancer research at a level commensurate with the overall percentage increase for NCI.

Colorectal Cancer Prevention.—Colorectal cancer is the third most commonly diagnosed cancer for both men and women in the United States and the second leading

cause of cancer-related deaths. Colorectal cancer affects men and women equally.

Although colorectal cancer is preventable and curable when polyps are detected

early, a General Accounting Office report issued in March 2000 documented that

less than 10 percent of Medicare beneficiaries have been screened for colorectal cancer. This report revealed a tremendous need to: (1) inform the public about the

availability and advisability of screening; (2) educate health care providers about

colorectal cancer screening guidelines.

CDC’s National Colorectal Cancer Screening Awareness Program is addressing

these needs by partnering with organizations like the DDNC and its coalition partners (AGA, ASGE, ACG, UOA) to develop an advocacy agenda emphasizing the

value of early detection. The digestive disease community hopes that this relatively

new program will do for colorectal cancer screening rates what the CDC’s Breast

and Cervical Cancer Screening Program has done for mammography and Pap smear

screening compliance.

The DDNC has seen first-hand the ambitious agenda that CDC and its partners

have developed to reduce the incidence of colorectal caner. We are convinced that

we can make a significant impact on screening rates across the country if given adequate resources. Therefore, the Coalition encourages the subcommittee to provide

CDC with $15 million in fiscal year 2002 (an increase of $6 million over last year)

for this important program.

Mr. Chairman, thanks to support provided by this subcommittee in past years the

NIDDK has been able to make important advances in the understanding and treatment of digestive diseases and improve the quality of life of many digestive disease

patients.

One digestive disease that concerns us greatly is irritable bowel syndrome (IBS)

a disorder that affects an estimated 35 million Americans. Many people with IBS

suffer in silence, unable to speak about the disease even to their family members.

The medical community has been slow in recognizing IBS as a legitimate disease

and the burden of illness associated with it. Patients often see several doctors before

they are given an accurate diagnosis.

Once a diagnosis of IBS is made, medical management is limited because the

medical community still does not understand the physiologic mechanism of the disease. Living with IBS is a challenge. Trying to learn how to manage the symptoms

is not easy.

There is a loss of spontaneity when symptoms may intrude at any time. Plans

made often need to be changed. IBS is unpredictable. One can wake up in the morning feeling fine and within a short time encounter abdominal cramping to the point

of being doubled over in pain and unable to function.

The unpredictable bowel symptoms may make it next to impossible to leave home.

It is difficult to ease pain that may repeatedly occur periodically throughout the day.

One becomes reluctant to eat for fear that just eating a meal will trigger symptoms

all over again. IBS has a broad and significant impact on a person’s quality of life.

It strikes individuals from all walks of life and results in a significant toll of human

suffering and disability.

While there is much we don’t understand about the causes and treatment of IBS,

we do know that IBS is a chronic complex of symptoms affecting as many as one

in five adults. In addition;

—It is reported more by women than men.

—It is the most common gastrointestinal diagnosis amonggastroenterology practices in the United States.

—It is a leading cause of worker absenteeism in the United States.

—It costs the U.S. health care system an estimated $8 billion annually.

Mr. Chairman, much more can still be done to address the needs of the nearly

35 million Americans suffering from irritable bowel syndrome and other functional

gastrointestinal disorders. We understand the challenging budgetary constraints

that this subcommittee is operating under, yet we hope you will carefully consider

the tremendous benefits to be gained by supporting a strong research and education

program for irritable bowel syndrome at NIH and CDC. Mr. Chairman, on behalf

of the millions of digestive disease sufferers, we appreciate your consideration of the

views of the Digestive Disease National Coalition.
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PREPARED STATEMENT OF THE DORIS DAY ANIMAL LEAGUE

Mr. Chairman and members of the Subcommittee on Labor, Health and Human

Services, Education and Related Agencies Appropriations, thank you for the opportunity to submit testimony on behalf of the 300,000 members and supporters of the

Doris Day Animal League requesting appropriations for the National Institute of

Environmental Health Sciences’ (NIEHS) National Toxicology Program Interagency

Center for the Evaluation of Alternative Toxicological Test Methods (NICEATM) for

Interagency Coordinating Committee for the Validation of Alternative Methods

(ICCVAM) activities for fiscal year 2002. This entity, ICCVAM, was permanently

authorized in 2000.

FUNCTION OF ICCVAM

The ICCVAM performs an invaluable function for regulatory agencies, industry,

public health, and animal protection organizations by assessing the validation of

new, revised and alternative toxicological test methods that have interagency application. After appropriate independent peer review of the test method, the ICCVAM

recommends the test to the federal regulatory agencies that regulate the particular

endpoint the test measures. In turn, the federal agencies maintain their authority

to incorporate the validated test method as appropriate for the agencies’ regulatory

mandates. This streamlined approach to assessment of validation of new, revised

and alternative test methods has reduced the regulatory burden of individual agencies, provided a ‘‘one-stop shop’’ for industry, animal protection, public health and

environmental advocates for consideration of methods and set uniform criteria for

what constitutes a validated test method. In addition, from the perspective of animal protection advocates, ICCVAM can serve to appropriately assess test methods

that can refine, reduce and replace the use of animals in toxicological testing. This

function will provide credibility to the argument that scientifically validated alternative test methods, which refine, reduce or replace animals, should be expeditiously integrated into federal toxicological regulations, requirements and recommendations.

HISTORY OF ICCVAM

The ICCVAM is currently composed of representatives from the relevant federal

regulatory and research agencies. It was created from an initial mandate in the NIH

Revitalization Act of 1993 for the NIEHS to ‘‘(a) establish criteria for the validation

and regulatory acceptance of alternative testing methods, and (b) recommend a process through which scientifically validated alternative methods can be accepted for

regulatory use.’’ In 1994, NIEHS established the ad hoc ICCVAM to write a report

that would recommend criteria and processes for validation and regulatory acceptance of toxicological testing methods that would be useful to federal agencies and

the scientific community. Through a series of public meetings, interested stakeholders and agency representatives from all 14 regulatory and research agencies, developed the NIH Publication No. 97–3981, ‘‘Validation and Regulatory Acceptance

of Toxicological Test Methods.’’ This report has become the sound science guide for

consideration of new, revised and alternative test methods by the federal agencies

and interested stakeholders.

After publication of the report, the ad hoc ICCVAM moved to standing status

under the NIEHS’ NICEATM. Representatives from federal regulatory and research

agencies and their programs have continued to meet, with advice from the

NICEATM’s Advisory Committee and independent peer review committees, to assess the validation of new, revised and alternative toxicological methods. Since then,

two methods have undergone rigorous assessment and are deemed scientifically

valid and acceptable. The first method, Corrositex, is a replacement for animalbased dermal corrosivity tests for some chemicals. The second, the Local Lymph

Node Assay, is a reduction and refinement of an animal test for the skin irritation

endpoint. The open public comment process, input by interested stakeholders and

the continued commitment by the federal agencies has led to ICCVAM’s success. It

has resulted in a more coordinated review process for rigorous scientific assessment

of the validation of new, revised and alternative test methods.

REQUEST FOR APPROPRIATIONS

On December 19, 2000, the ‘‘ICCVAM Authorization Act’’ which makes the entity

a permanent standing committee, was signed into Public Law No. 106–545. For the

past few years, the NIEHS has provided approximately $1 million per fiscal year

to the NICEATM for ICCVAM’s activities. In order to ensure that federal regulatory

agencies and their stakeholders benefit from the work of the ICCVAM, it is impor-
545

tant to fund it at an appropriate level. I respectfully urge the Subcommittee to support an appropriation for the NIEHS’s NICEATM for ICCVAM’s activities at $3 million for fiscal year 2002. This appropriation request includes all FTEs, funding for

independent peer review assessment of test methods and meetings of the ICCVAM

and other activities as deemed appropriate by the Director of the NIEHS.

REQUEST FOR COMMITTEE REPORT LANGUAGE

I also respectfully request the Subcommittee consider the following report language for the Senate Labor, Health and Human Services, Education and Related

Agencies Appropriations bill:

‘‘The Committee supports the assessment of scientific validation of new, revised

and alternative toxicological test methods by the ICCVAM. The Committee directs

the regulatory and research agencies, including the National Institute of Environmental Health Sciences, Food and Drug Administration and Environmental Protection Agency, to use the expertise and credibility of the ICCVAM for these assessments to streamline their individual consideration of new, revised and alternative

toxicological test methods. The Committee also urges the federal regulatory and research agencies to incorporate scientifically validated new, revised and alternative

test methods into their regulations, requirements and recommendations in an expeditious manner.’’

Thank you for the opportunity to submit this request on behalf of the Doris Day

Animal League.

PREPARED STATEMENT OF THE DYSTONIA MEDICAL RESEARCH FOUNDATION

Chairman Specter, thank you for the opportunity to describe for the Subcommittee how dystonia has affected our lives and our recommendations for fiscal

year 2002 federal funding of dystonia research.

My name is Rosalie Lewis, president of the Dystonia Medical Research Foundation. Three of my four sons have dystonia, and my fourth son is a carrier of the

DYT1 gene which is responsible for generalized dystonia that begins in childhood.

As there is no cure for dystonia, and only in the past thirty years has research given

way to treatments other than brain surgery, my sons have had some benefit from

oral medication and botulinum toxic injections. Although we are fortunate to have

these treatments available, the various drugs have significant cognitive side-effects.

Dystonia is a neurological movement disorder characterized by involuntary muscle

contractions and postures. There are several different types of dystonia, including:

focal dystonias, affecting specific parts of the body, such as the arms, legs, neck,

jaw, eyes, vocal cords; and generalized dystonia, affecting many parts of the body

at the same time. Some forms of dystonia are genetic and others are caused by injury or illness. Dystonia does not affect a person’s consciousness or intellect, but is

a chronic and progressive physical disorder for which, at this time, there is no cure.

We believe that some form of dystonia affects about 300,000 people in North America.

In the past few decades, dystonia researchers have made several exciting scientific

advancements and have been able to rapidly turn laboratory and clinical research

into diagnostic examinations and treatment procedures, directly benefitting those affected. Genetics, in particular, is opening up new understanding into the cause and

pathophysiology of the disorder. Thus far, 12 dystonia related genes have been identified. In 1997, the DYT1 gene for childhood onset dystonia was identified, and we

now have a genetic test available for this particular type of dystonia.

RESEARCH, AWARENESS, AND SUPPORT

It is an exciting time to be involved in dystonia research and awareness. Researchers are becoming more interested in movement disorders and dystonia at the

National Institutes of Health (NIH), and research is yielding promising clues for

better understanding and management of this disorder.

One way the Dystonia Foundation has advocated for more research on dystonia,

is by funding ‘‘seed’’ grants to researchers. Thus far, the Dystonia Foundation has

funded 338 grants, and 3 fellowships, totaling more than $17 million. Due to our

advocacy there is a growing number of talented researchers dedicated to understanding the biochemistry of dystonia, genetic causes, new therapeutics and the

ramifications of an epidemiology study.

Another primary goal of the Dystonia Foundation is education of both lay and

medical audiences. Every year the Foundation conducts several medical workshops

and regional symposiums to present, discuss, and disseminate comprehensive med-
546

ical and research data on dystonia. In January, 2001 NINDS co-sponsored a genetics

and animal models meeting, designed to involve not only prominent researchers but

inviting junior investigators to participate in the discussions. Additionally, in October 1996, the NIH was one of our co-sponsors for an international medical symposium, which featured 60 papers on dystonia and 125 representatives from 24 countries. Our next major international symposium is scheduled for September, where

again we anticipate NINDS to co-sponsor the meeting.

Since 1995, over 3,000 educational medical videos have been distributed to hospitals, medical and nursing schools, and at medical conventions. Now, we have a

children’s video to increase public awareness of this devastating disorder. Media

awareness is conducted throughout the year, and especially during Dystonia Awareness Week, observed nationwide from October 14 through 20, 2001.

The Dystonia Foundation has over 200 chapters, support groups, and area contacts across North America. In addition, there are 15 international chairpersons

whose mission is to increase awareness, children’s advocacy, development, extension, the Internet, leadership, medical education, an on-line news group, and symposiums. Furthermore, patient symposiums are held regionally to provide the latest

information to dystonia patients and others interested in the disorder. Last year we

held over eight regional symposiums reaching approximately 2,000 affected families.

DYSTONIA AND THE NATIONAL INSTITUTES OF HEALTH

The Dystonia Medical Research Foundation recommends an increase to $23.7 billion or 16.5 percent for NIH overall, and a 16.5 percent increase for NINDS and

NIDCD or $1.37 billion and $350 million respectively. This increase reflects a request to double the NIH budget in five years. However, we request that this increase for NIH does not come at the expense of other Public Health Service agencies.

Dystonia is the third most common movement disorder after Parkinson’s and

tremor, and effects six times more people than better known disorders such as Huntington’s, muscular dystrophy and ALS or Lou Gehrig’s Disease. We ask that

NINDS fund dystonia-specific extramural research at the same level that it supports

research for other neurological movement disorders.

We urge the Subcommittee to recommend that NINDS provide the necessary

funding for extramural research and a large scale dystonia epidemiological study

and increase its efforts to educate the public and medical community about dystonia

though cosponsorship of workshops and seminars. We also encourage the Subcommittee to support NIDCD in its efforts to revamp its strategic planning process

by implementing a Strategic Planning Group which will help NIDCD as they: consider applications for high program priority; develop program announcements and

requests for applications; and develop new research areas in the Intramural Research Program.

The ultimate goal of the Dystonia Foundation is a cure for dystonia. Until that

goal is realized, we are hungry for any knowledge about the nature of dystonia and

for more effective treatments with fewer side-effects. We have amassed many exceptional and diligent researchers, committed to our goal, and our top priority is funding their very important research. But the Foundation cannot do it alone. We need

federal support through NIH, NINDS, and NIDCD to continue to fund good research

and eliminate this debilitating disease.

I would like to introduce Mr. Peter Cohen.

Thank you Rosalie, my name is Peter Cohen and I have dystonia. Because of this

neurological disorder, I have difficulty walking, standing, writing, and driving a car,

just to mention a few daily activities I can’t take for granted. Dystonia affected me

first when I was a teenager, I developed muscle spasm and tremors. By my late

twenties it became increasingly difficult to walk, my neck would turn involuntarily,

and the tremors had spread to much of my body.

As these physical changes worsened over time, dystonia began to affect my professional and personal life. It became virtually impossible for me to read, write, type

or sit in a comfortable working position, and I was forced to give up a successful

career as an attorney. Furthermore, it became increasingly difficult to be in social

situations. I felt physically and emotionally awkward because of the challenges presented by dystonia. I started isolating myself because I was ashamed of my appearance.

For the past couple of years I have tried to move beyond this shame. I look forward to a day when there is a cure for this debilitating disorder and I can fully

participate in life.

Thank you Peter, Chairman Specter, we ask that you aggressively support medical research, specifically for movement disorders and brain research. By doing so,
547

you are doing a tremendous service for myself and my family, for Peter, and to the

hundreds of thousands of people and families affected by dystonia.

Thank you very much.

THE DYSTONIA MEDICAL RESEARCH FOUNDATION

The Dystonia Medical Research Foundation was founded 25 years ago and has

been a membership-driven organization since 1993. Since its inception, the goals of

the Foundation have remained the same: to advance research for more effective

treatments of dystonia and ultimately a cure; to promote awareness and education;

and support the needs and well being of affected individuals and their families.

PREPARED STATEMENT OF EASTER SEALS

Easter Seals is a national nonprofit service organization dedicated to helping children and adults with disabilities achieve independence. Collectively, Easter Seals

assists more than one million people annually through a national network of 105

affiliates. Easter Seals appreciates the opportunity to report on the success of ‘‘Early

Childhood Development Project for the Mississippi Delta Region (Delta Project),’’

and to recommend that $1.6 million be allocated in fiscal 2002 to conduct the

project’s fifth and final year.

To date, the Delta Project has provided essential services to 7,000 children with

disabilities who would otherwise have gone without needed evaluation and therapy

services. Hundreds of Delta families have received counseling, training, and support

that helps parents understand and promote their child’s development. Delta Project

staff have provided technical assistance and training to hundreds of child care workers, early intervention and health department professionals, teachers, therapists,

doctors, and others to enhance competencies for better helping children with disabilities develop and learn. The Delta Project is committed to building lasting local capacity for improved service to children with disabilities and associated developmental and educational results. Delta project activities are conducted collaboratively

with state and local health and education agencies and other providers, and do not

duplicate or supplant available services.

DELTA PROJECT RATIONALE AND DESIGN

Children with disabilities in the Mississippi Delta are not receiving the appropriate early intervention and education services that they need to maximize development and learning. Proportionately lower family incomes, fewer public resources,

shortages of pediatric personnel and specialized services, and inadequate support

systems for families and staff are among the factors contributing to this situation.

Geographic isolation, caused by wide dispersal of residents and community resources, poor roads, and lack of transportation, make it difficult for families to access services locally and out-of-region, and impede the ability of service providers

to be available as needed. As a result, increased attention and supports are needed

to promote more effective implementation of the Individuals with Disabilities Education Act (IDEA) in Delta communities, as well as other rural areas across the

country.

The Delta Project is demonstrating strategies for building local capacity to improve early intervention and education services and enhance developmental and

educational results for children with disabilities in the Delta regions of Arkansas,

Louisiana and Mississippi. It offers a nationally-significant, replicable model for

overcoming chronic gaps in local services and addressing parental and personnel

preparation needs.

The Delta Project was officially launched in October 1998, with significant project

activities appearing in targeted Delta communities in Arkansas, Louisiana and Mississippi in January 1999. Project implementation is occurring in phases, reflecting

annual appropriations and U.S. Department of Education funding cycles. To date,

Congress has approved a total of $3.725 million for this five-year initiative. A final

appropriation of $1.6 million is recommended for fiscal 2002, to enable Easter Seals

to provide full-scale services, training, and technical assistance in 45 Delta counties

and parishes, and to report overall project findings. No further requests to earmark

Education Department funds for this initiative will be made after 2002. To the extent necessary, Easter Seals will sustain needed capacity-building efforts using existing public and private funds.

The Delta Project is bringing needed expertise, technical assistance, and support

to local families, educators and service providers, and community decision-makers

that are currently lacking in the Delta. Major goals of the Delta Project are:
548

—Improve child find activities.

—Improve the quality and availability of appropriate early intervention and childhood development services for Delta region children with disabilities.

—Increase parent information and skills to better promote child development and

learning.

—Increase the capacity of local educators and service providers to better serve

children with disabilities and their families.

—Increase the ability of community decision-makers to create solutions to improve access to appropriate services for children with disabilities.

The Delta Project achieves these goals through collaboration with state and local

health and education personnel, parents of children with disabilities, and local decision-makers, by:

—providing training and technical assistance to teachers, other education personnel, public health practitioners, child care workers and others to elevate

their skills and ease in assisting children with disabilities and families;

—providing training and support to families with children with disabilities to promote increased understanding of child development and parent-child activities

that advance child development and learning;

—facilitating collaboration and problem-solving among local agencies, community

resources and decision-makers to improve services and results for children with

disabilities; and,

—offering short-term, otherwise unavailable evaluation and essential services for

children with disabilities.

DELTA PROJECT STATUS & RECENT ACTIVITIES

Although Easter Seals is seeking final year funding for the Delta Project in fiscal

2002, the project is programmatically at its mid-point in terms of implementation

and capacity building effect. A summary of significant accomplishments and selected

activities during the past six months (October 1, 2000 to March 31, 2001) follows.

Over the past two and one-half years, the Delta Project has proven an effective

catalyst for necessary change in Delta communities. Significant accomplishments include:

—Dramatically enhanced child find efforts through capacity building with Head

Start agencies, child care providers, physicians, local health departments and

other service agencies. For example, in East Carroll Parish, Louisiana, these efforts resulted in the identification and referral of ten children with developmental delays for services. This may not seem noteworthy until contrasted with

previous years during which no children with developmental needs were found,

despite the birth of hundreds of children annually in an at-risk environment of

crushing poverty, teen pregnancy, and inadequate pre-natal care. In Bolivar

County, Mississippi, project staff collaborated with Head Start to screen 282

preschool children for developmental delay and other needs, of whom 49 were

referred for additional testing.

—Substantial increase in access to early intervention services in the Delta because of developmental screenings, evaluations, and short-term therapy services

provided by Project staff. A total of 438 children received short-term therapy

services from project staff across the three-state region. It is important to note

that these services meet not only the immediate needs of specific children, but

also address personnel and parent needs as well. In Arkansas, for example, the

majority of children were referred by school personnel triggering direct service

to children, accompanied by consultation on classroom programming, behavioral

issues, and augmentative communications needs. In many instances, parents

were included in these consultations.

—Increased competency of nearly 400 Delta health and education professionals to

better understand and serve children with disabilities through participation in

15 project training sessions that addressed topics of greatest concern. For example, two tri-state training conferences were held in Little Rock; ‘‘Communication

Development with Autistic Spectrum Disorder,’’ held in October 2000 and ‘‘Managing Children’s Behavior in a Positive, Developmentally Appropriate Way’’ in

February 2001. A workshop was held in Greenville, Mississippi in late march

2001 entitled ‘‘Sensory Processing: From Definition to Intervention,’’ which was

attended by 53 professionals and paraprofessionals from the three-state Delta

region.

—Higher level of knowledge and skills development among Delta parents due to

project training and support. For example, three parent workshops on Early

Brain Development were conducted in Morehouse and Richland Parishes, Louisiana, that helped 47 parents understand early brain development and its rel-
549

evance to their child’s abilities and needs. In Arkansas, project staff helped hundreds of families, including 40 parents who received individualized consultations on developmental milestones, home activities to enhance development, positioning techniques, feeding strategies, and effective use of assistive technology.

—Greatly increased awareness of child development needs and services in the

Delta through distribution of materials, participation in agency initiatives, presentations, and use of the media. For example, the project developed and distributed 2,881 copies of a basic child development letter titled ‘‘Is Your Child on

Track,’’ which helps parents, personnel, and others to better understand child

development milestones, recognize potential delays, and to facilitate evaluations, as appropriate. Delta project staff regularly contribute to health and education agency decision-making, such as First Connections in Arkansas, Children’s Coalition in Louisiana, and First Steps in Mississippi, and Interagency

Coordinating Committees in all three states. Community contacts with faith

groups, community groups and the media are a regular part of Delta Project

outreach.

The Delta Project is fully operational in 45 counties and parishes, representing

the entire area originally targeted based on need, as follows:

—Arkansas.—Arkansas, Ashley, Bradley, Chicot, Crittenden, Cross, Desha, Drew,

Lee, Lincoln, Mississippi, Monroe, Phillips, Poinsett, and St. Francis.

—Louisiana.—Avoyelles, Catahoula, Concordia, East Carroll, East Feliciana,

Franklin, Livingston, Point Coupee, Madison, Monroe, Richland, St. Helena,

Tensas, West Carroll, and West Feliciana.

—Mississippi.—Adams, Bolivar, Coahoma, Claborne, De Soto, Humphreys,

Issaquena, Jefferson, Leflore, Sunflower, Sharkey, Tunica, Warren, Washington,

and Wilkerson.

Note.—Project staff are currently conducting a comprehensive needs assessment

in parishes and counties listed in italics. Planning and coordination services will be

available in these targeted areas this fiscal year, and full project services will be

implemented beginning October 2001.

Project offices are located in Little Rock, AR, Monroe, LA, Covington, LA, and

Greenville, MS. Easter Seals Arkansas based in Little Rock serves as project headquarters, coordinating project services in Arkansas and overseeing region-wide

training, technical assistance, evaluation, and reporting activities.

Highlights for the period, by state, characterize the Delta Project’s fundamental

and lasting contribution to addressing chronic needs at the local and national levels.

In Arkansas, selected accomplishments during the past six months include:

—Educated 30 mothers attending a Lee County WIC (Women, Infants and Children) Clinic about developmental milestones and potential indications of developmental delay, and guidance on accessing needed services.

—Assessed 81 children for developmental delay, with one-third being referred to

the early intervention program.

—Initiated 171 contacts with social, health, educational, parenting, and therapy

providers in the Delta to enhance child find efforts; 27 contacts were with physicians and 85 visits were made to Head Start and community child care centers.

—Participated in health fairs in Monroe and Desha counties and provided information to about 375 people on child development and early intervention.

—Surveyed 772 therapists in the three-state Delta region regarding practices and

attitudes on delivering school-based therapy services in the classroom

(inclusionary) versus on a ‘‘pull-out basis. Therapists generally favored services

outside of the classroom, while administrators and teachers supported an

inclusionary approach.

In Louisiana, selected accomplishments during the past six months include:

—Boosted child find results in chronically underserved areas, with 40 percent of

the children assessed by project staff referred to the early intervention program.

—Met with LSU Shreveport medical staff address concerns that children referred

to ChildNet for early intervention services after medical treatment were not entering the system or accessing needed services. Project staff worked out a solution, whereby project staff will facilitate the referral process between LSU and

ChildNet and support ChildNet in reducing service delays.

—Collaborated with Child Search Coordinators to identify and address barriers to

raising awareness among parents regarding the benefits of early intervention.

In Mississippi, selected accomplishments during the past six months include:

—Established a collaborative relationship with the Delta Area Health Education

Centers and Delta Medical Society to schedule presentations by project staff

and disseminate project information.
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—Moved project office from Jackson to Greenville to better access and support

local early intervention and education systems serving children with disabilities.

—Aided development of a proposal by Part C leadership to increase Medicaid payment for early intervention services that has been submitted to the governor for

review.

—Scheduled regional training conferences for therapists, teachers, and parents to

be held in Greenville, MS in spring 2001 on sensory processing, inclusion or intrusion, and therapeutic interventions.

Detailed information on Delta Project activities and findings are described in a

mid-year report to the U.S. Department of Education, submitted May 2001.

Delta Project accomplishments and outcomes are evaluated by the University of

Alabama’s Civitan International Research Center, based in Birmingham, Alabama.

The Civitan International Research Center is a University-Affiliate Program with

research and evaluation expertise in early childhood development and programs

serving children with disabilities in the Mississippi Delta Region. Civitan conducts

an independent evaluation of the Delta Project, including site visits, throughout the

year. During the past six months, evaluation staff conducted project site visits in

Arkansas on January 30–31, 2001; in Mississippi on February 22–23, 2001; and

Louisiana on March 8–9, 2001. Civitan reports its findings to the U.S. Department

of Education on a semi-annual and annual basis. Easter Seals is pleased that evaluation findings to date are favorable.

Easter Seals greatly appreciates the Subcommittee’s strong support for initiating

and continuing the ‘‘Early Childhood Development Project for the Mississippi Delta

Region.’’ The Delta Project is beginning to have a dramatic, positive, and lasting impact in Arkansas, Louisiana, and Mississippi. It is generating valuable lessons and

techniques for use in underserved areas throughout the country. Investment of $1.6

million in fiscal 2002 will support final year operations in the three-state region,

evaluation and reporting, and the dissemination of findings and recommendations.

Proposed statutory and report language for fiscal 2002 is attached for your information and use. Thank you for supporting the Delta Project.

EARLY CHILDHOOD DEVELOPMENT PROJECT FOR THE MISSISSIPPI DELTA REGION

The following statutory and report language is proposed for use in the fiscal 2002

Appropriations Bill for Labor-HHS-Education for the U.S. Department of Education,

Office of Special Education and Rehabilitative Services, Special Education programs

IDEA Research and Innovation.

FISCAL 2002 APPROPRIATIONS STATUTORY LANGUAGE

‘‘Of the funds provided, $1,600,000 shall be available for Easter Seals Arkansas

‘‘Early Childhood Development Project for the Mississippi Delta Region.’’

REPORT LANGUAGE TO ACCOMPANY FISCAL 2002 APPROPRIATIONS BILL

‘‘The Committee continues to be concerned about unmet needs among children

with disabilities in rural areas, particularly the Mississippi River Delta, and the

lack of adequate support in these areas for parents, school personnel, child care

staff, and health providers to overcome chronic barriers to effective local service delivery. The bill addresses these concerns by providing $1,600,000 to continue the

Early Childhood Development Project for the Mississippi River Delta Region to be

carried out by Easter Seals Arkansas in Arkansas, Louisiana and Mississippi. The

Committee recognizes that this multi-year project provides unduplicated early intervention and early childhood services to children with disabilities ages birth through

twelve years, assists parents, and builds lasting local capacity to better provide and

coordinate such services to maximize developmental and educational results. Valuable solutions generated by this project will be available for replication across rural

America.’’
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DELTA PROJECT—SUMMARY OF SERVICES

[October 1, 2000–March 31, 2001]

Arkansas Louisiana Mississippi Total Children Seen For

Period

Total Number

of Visits For

Period Number of Children Seen Number of Visits Number of Children Seen Number of Visits Number of Children Seen Number of Visits

Evaluations ................................................................................................................ 42 52 15 15 11 31 68 92Consultations ............................................................................................................. 29 29 3 3 ...................... ...................... 32 32Screenings ................................................................................................................. 32 1 ...................... ...................... 282 ...................... 314 1Therapy:

OT ...................................................................................................................... ...................... ...................... 13 137 ...................... ...................... 13 137PT ...................................................................................................................... ...................... ...................... ...................... ...................... 1 4 1 ......................SLP .................................................................................................................... ...................... ...................... 20 203 ...................... ...................... 20 203Other ................................................................................................................. ...................... ...................... 4 54 ...................... ...................... 4 54

Total ............................................................................................................. 103 82 41 412 294 35 438 529

Number of

Individuals

Trained

Number of

Trainings

Conducted

Number of

Individuals

Trained

Number of

Trainings

Conducted

Number of

Individuals

Seen

Number of

Trainings

Conducted

Total Trained Total

Trainings

Conducted

Inservice ..................................................................................................................... 205 9 126 5 53 1 384 15Parent Training/Consultations ................................................................................... 38 42 114 114 15 35 167 191

Total ............................................................................................................. 243 51 240 119 68 36 551 206
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PREPARED STATEMENT OF THE EPILEPSY FOUNDATION

The Epilepsy Foundation is the national voluntary organization that works for

people affected by seizures through research, education, advocacy and service.

Founded in 1968, its national office is based in Landover, Maryland. The national

office and its network of more than 60 affiliates across the country provide many

direct services to individuals and families, including: community education; employment assistance; recreation; professional education conferences; assisted living; and

case management and counseling.

The Epilepsy Foundation supports medical research to find better treatment and

an eventual cure for epilepsy, and works with federal government agencies and Congress to advance the interests of people with epilepsy.

Epilepsy is a neurological condition characterized by recurrent, unprovoked seizures. At least 2.3 million people currently have epilepsy; the number of people affected by epilepsy, family members, teachers, care givers, employers is an exponentially far larger number. A recent CDC study in Texas found 1.8 percent of adults

had been diagnosed with epilepsy or seizures. Approximately 181,000 new cases of

epilepsy occur each year; 10 percent of all Americans will experience seizures in

their lifetimes.

MEDICAL RESEARCH ADVANCEMENT

The Epilepsy Foundation actively supports the efforts of Congress to double funding for the National Institutes of Health. We are pleased that NIH maintains strong

bi-partisan support and has enjoyed significant increases in funding. These investments in our nation’s health are paying dividends. In the last decade considerable

progress has been made in identifying genes associated with epilepsy and in developing medications, devices and surgical treatments.

Almost a year ago, participants in a historic scientific conference predicted that

prevention and a cure for epilepsy are only a generation away. Now the scientific

community is working on next steps and ways to measure progress toward those

goals. The conference, ‘‘Curing Epilepsy: Focus on the Future’’, was sponsored by the

National Institute for Neurological Disorders and Stroke (NINDS), which is the primary federal sponsor of epilepsy medical research. The Epilepsy Foundation was

one of the co-sponsors. NINDS, together with scientific experts have developed a set

of benchmarks and priorities to guide future research.

Specifically, the conference and the benchmarks look at how epilepsy begins, ways

of identifying people at risk and how to develop treatments that will prevent epilepsy in those people as well as continuing the search for new therapies, free of side

effects, to prevent seizures. Clearly there are significant opportunities for advancements in epilepsy research.

THE IMPACT OF SEIZURES

Despite this progress and hope for the future, epilepsy remains a chronic condition that usually requires a lifetime of medical treatment. As many as 44 percent

of people with epilepsy continue to have seizures despite treatment; 56 percent have

early or delayed seizure control with treatment. Currently, there is no cure for epilepsy.

A recent cost study estimates that the cost of epilepsy, focussed on its most narrow measures, the direct medical costs, and the indirect costs as identified by the

impact on earning and home production, is $12.5 billion annually.

The consequences of seizures continue to be severe and life altering, even among

people with well-controlled seizures. Their impact spans employability, income levels, education, marriage, fertility, life expectancy and life style. The Texas study

showed high levels of pain, anxiety, poor health, depression, and fatigue among

adults living in the community, to the degree that their quality of life was negatively affected about 40 percent of the time.

Twenty five percent of all people with epilepsy are unemployed; among those who

are partially or poorly controlled, unemployment approaches 50 percent. Marriage

and fertility rates are reduced in people with epilepsy, there is an increased risk

of brain damage and increased mortality and stigma remains a fact of life for too

many people fueling discrimination and isolation from the mainstream of life.

Children with epilepsy are at special risk of learning difficulties. Studies have

documented deficits in language, visual-spatial function, problem solving, and

adaptive behaviors, even in the absence of co-morbidity. Children with epilepsy have

unique difficulties when compared to those with other chronic illnesses such as asthma and diabetes; achievement scores are lower, there are problems with self-concept, depression, and behavior. These studies demonstrate the critical importance of
553

early recognition and treatment, as well as the often unanticipated consequences

that a diagnosis of epilepsy can have.

RESEARCH AND PUBLIC HEALTH RECOMMENDATIONS

The Epilepsy Foundation supports the doubling of the NIH budget. We expect

that the NINDS will update Congress and the epilepsy community on the progress

being made to implement the recommendations from the conference entitled ‘‘Curing

Epilepsy: Focus on the Future.’’ Continuing to invest in basic and clinical research

is crucial to meeting our goal of preventing and curing epilepsy. However much

more needs to be done to address the impact of epilepsy and to improve the quality

of life of those living with the disorder. Experts agree that timely recognition of seizures and effective treatment can reduce the risk of subsequent brain damage, as

well as disability and mortality from injuries incurred during a seizure and from

recurring seizures.

In 1993 Congress recognized this need and directed the Centers for Disease Control and Prevention (CDC) to develop an epilepsy program within the National Center for Chronic Disease Prevention and Health Promotion. As a result, the CDC initiated a number of activities including a public health campaign geared toward teen

awareness and education, a project with the Agency for Healthcare Research and

Quality to develop provider education materials and surveillance and prevention research activities to better analyze trends in access to care, levels of care and other

demographic variables.

In 2000, Congress expanded the program by passing the Children’s Health Act of

2000. The goals for this program include progress in research, epidemeology and

surveillance, early detection, improved treatment, public education and expansion of

interventions to support people with epilepsy and their families in their communities. The Children’s Health Act of 2000 also authorized a new program within the

Health Resources and Services Administration. HRSA is directed to create grants

to improve access to health and other services regarding seizures; and to gear

projects toward encouraging early detection and treatment for those living in medically underserved areas.

This agenda is much larger than current resources for the program. In fiscal year

2001, Congress appropriated $4 million for the CDC epilepsy program. Additional

resources will be needed in order to expand the reach of the program into local communities and to fulfill the legislative intent.

FISCAL 2002 FUNDING RECOMMENDATIONS

Epilepsy research funded by the National Institute of Neurological Disorders and

Stroke is vital to continuing the fight against epilepsy. The promise of future breakthroughs in epilepsy research can only be achieved by increased funding for epilepsy

research and prevention programs. The Foundation urges Congress to increase the

federal commitment to epilepsy research by allocating sufficient funding for the

NINDS, the Centers for Disease Control and the Health Resources Services Administration.

—Epilepsy Program at the Centers for Disease Control and Prevention.—The Epilepsy Foundation supports a $3 million dollar increase in funding for the CDC

epilepsy program.

—Health Resources and Services Administration.—The Epilepsy Foundation supports an initial investment of $3 million in order to create demonstration

projects to improve access to health care for people with epilepsy.

—Doubling the National Institutes of Health Budget.—The Epilepsy Foundation

supports the efforts to double the funding for the NIH, particularly the National

Institute of Neurological Disorders and Stroke (NINDS). In keeping with this

effort, we support an increase to $1,370.6 million for NINDS in fiscal year 2002.

The Foundation urges Congress to support a major expansion of epilepsy research within NINDS. In 1999, NINDS spent $74 million on epilepsy research.

We are seeking a commitment to double that amount by fiscal year 2005.

Thank you for the opportunity to submit testimony to the Subcommittee. We look

forward to working with you in the 107th Congress.

PREPARED STATEMENT OF THE FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY

SOCIETY

Mr. Chairman, it is a great pleasure to submit this testimony to you today.

My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am testifying

today as President & Chief Executive Officer (CEO) of the Facioscapulohumeral
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Muscular Dystrophy Society (FSH Society, Inc.) and as an individual who has this

devastating disorder.

We are excited to report that during the past several months, the National Institutes of Health (NIH) have announced a series of initiatives to accelerate research

on Facioscapulohumeral Muscular Dystrophy (FSHD). For the first time since its inception, the NIH has requested grant applications whose purpose is to explore and

develop research that will broaden the base of knowledge on FSHD. We are indebted to you, Senator Arlen Specter, as well as Representative John Porter, Chairman U.S. House of Representatives Subcommittee on Labor, HHS, Education and

Related Agencies, formerly of U.S. House of Representatives, as well as the directors

and staff of the National Institute of Neurological Disorders and Stroke (NINDS)

and the National Institute of Arthritis and Musculoskeletal and Skin Diseases

(NIAMS) at the NIH for this progress.

The FacioScapuloHumeral (FSH) Society, incorporated in 1991, solely addresses

specific issues and needs regarding facioscapulohumeral muscular dystrophy

(FSHD). We provide public awareness of FSHD by providing information, referral,

education, and advocacy on FSHD. Additionally, the FSH Society offers assistance

and support to patients, families, physicians, and other professionals. The Society

publishes a newsletter with information about advances in research, political action

effecting FSHD research and profiles of people with FSHD. We have awarded

$650,000 in grants toward the prevention, cause and treatment of FSHD for research projects, post-doctoral and research fellowships and provided training support to institutions and fellowships to individuals in the field of FSHD research

worldwide. The FSH Society promotes collaborative research and collects and disseminates research information. The Society organizes and sponsors annual international and national scientific meetings on FSHD as well as annual international

and national patient network day meetings.

FSHD is a neuromuscular disorder that is inherited genetically and has an estimated frequency of one in twenty thousand (1/20,000). FSHD affects 12,500–37,500

persons in the United States. The major consequence of inheriting this disease is

that of a clinically unpredictable and progressive and severe loss of skeletal muscle,

with the usual pattern of initial noticeable weakness of facial, scapular and upper

arm muscles and subsequent developing weaknesses of other skeletal muscles. Retinal and cochlear disease can often be associated with FSHD although the pathogenesis and causative relationship to FSHD remains completely unknown. FSHD

wastes the skeletal muscles and gradually but surely brings weakness and reduced

mobility. Many with FSHD are severely physically disabled and spend the last 30

years of their lives in a wheelchair. The toll and cost of FSHD physically, emotionally and financially is enormous. FSHD is a life long disease that has an enormous

cost-of-disease burden and is a life sentence for the innocent patient and involved

persons and their children and grandchildren as well.

We are in an unprecedented time with the publication of the entire human genome sequence. We have spent an enormous amount of money in genomic research

that is coming to fruition and we hope to begin to realize the payoff for this investment. However, this chapter is not closed and we are not done with understanding

FSHD. FSHD is a complex and difficult disease and the mechanism of this disease

is tightly bound to the next steps for genome research. FSHD is an enormously rich

disease to study with its involvement in telomeres, repeats, chromosomal ‘‘crosstalk’’, new protein and DNA models for transcription of the genome, and many other

new areas outlined for investigation by the entire genome community as critical

areas for the next steps to understanding how the human genome and physiome

works. FSHD may well be the only human disease that can be used as a model for

the next generation of novel genomic inquiry.

A decade of progress in FSHD has led to the discovery of a novel genetic phenomena of crossover of subtelomeric DNA between chromosomes (4 and 10) in both

normal individuals and diseased individuals and to the discovery that

facioscapulohumeral muscular dystrophy may be the only human disease caused by

a deletion-mutation causing a position effect variegation (PEV). PEV causes DNA

in one part of the genome to affect DNA in other parts of the genome. In FSHD,

DNA at the very end of the chromosome (telomere) interferes with DNA upstream

towards the center (proximal) of the chromosome. Despite remarkable genetic insight and immense progress by a small team of scientists worldwide, the nature of

the gene product(s) remain enigmatic and the biochemical mechanism and cause of

this common muscle disease remains absolutely unknown and elusive.

FSHD, in particular, and muscular dystrophy in general appear to be of little interest to the pharmaceutical industry, biotechnology industry and Wall Street. No

privately or publicly owned company is currently pursuing FSHD research. Unlike

Alzheimer’s, Parkinson’s disease or breast cancer with hundreds of millions of re-
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search dollars from the NIH supplemented by the enormous investments from the

pharmaceutical and biotechnology sector, FSHD has nowhere to go in the private

sector. We rely totally on NIH funding and that of voluntary health organizations

which raise research funds from the public, to advance knowledge in this field.

Neuromuscular and muscle disease has one of the highest cost-of-disease burdens in the U.S. economy. Yet, of $20.5 billion annually given to NIH, approximately $19

million is spent on all muscular dystrophy research and, of that amount, conservatively $450,000 is currently being spent on the third most prevalent and third largest dystrophy, FSHD. Clearly, the muscular dystrophies are significantly underfunded by NIH. In last year’s testimony, we reported the NIH had not responded

to the past three years of House and Senate Reports accompanying the appropriations bill Language. We are pleased to report a very different picture this year.

The FSH Society with the NINDS, the NIAMS and the and the NIH Office of

Rare Diseases (ORD) held ‘‘The 3rd International Conference on the Cause and

Treatment of FSHD’’ on Monday, May 8, 2000. The research community, the clinical

community, the observers and the NIH related experts agreed that it was a truly

outstanding, top-rate and excellent meeting. We successfully assembled the leading

FSHD researchers from all over the world at the NIH in Bethesda, Maryland where

they shared their findings with each other and the NIH. The Directors and Staff

at the NIH developed an excellent program to aid in the development of a portfolio

for FSHD. The Research Planning Conference held Tuesday, May 9, 2000 generated

a multitude of ideas on how to move forward on the FSHD agenda.

The May 9, 2000 baseline of recommendations by expert scientific panel on FSHD

for evaluating priorities is as follows and to date the NIH is beginning to accomplish

the sixteen items listed in this set. Recommendations for future directions, organized by topic, are listed as follows:

A. Molecular Processes; 1. Characterize the molecular pathogenesis of FSHD; elucidate the role of the repeats associated with the disease as well as what causes

their deletion; 2. Determine the relationship between repeat length and its effect on

the degree to which disease is manifested (penetrance); 3. Determine the gene sequence and whether the repeats are acting as suppressors or insulating units; 4.

Clarify how similarity of regions on chromosomes 4 and 10 may relate to FSHD.

B. Tissue Changes; 5. Characterize changes in muscle as the disease develops; 6.

Determine basis of differential involvement of muscles; 7. Explore the role of inflammation in FSHD; 8. Study properties of muscle cells derived from affected tissue.

C. Possible Therapies; 9. It was speculated that it may become possible to repair

the disease locus by selected and targeted addition of 3.3 kb repeats to the disease

locus on chromosome 4; 10. The modification of cultured FSHD regenerative muscle

cells that would reverse their higher sensitivity to oxidative stress. Such cultured

cells, with better ability to respond to oxidative stress, might then be used for treatment of patients.

D. Population Based Studies; 11. Establish patient registries and recruit additional families for study; 12. Determine if a nonstandard locus produces FSHD.

E. Resources; 13. Create new animal models; 14. Facilitate use of differential gene

and protein expression techniques; 15. Promote development and use of noninvasive imaging techniques; 16. Enhance formation of clinical and basic research

consortia.

Each year anew the FSH Society defines, at the request of the entire international

and global molecular genetics and clinical research community, the most crucial

issues in FSHD research today and in the coming several years—these following

nine areas represent the majority of efforts to be made given recent advances in

technology, science and understanding of FSHD.

A. An International clinical and molecular data (resource) base. Although a complicated issue for several reasons (homogeneity of clinical and genetic data, access

etc.), presence of such a facility should greatly improve; 1. our insight in the natural

history, and genotype-phenotype relationships as support for patient counseling and

management; 2. the availability of biological material (DNA, cell lines, muscle biopsies etc.) for research purposes; the design of (homogeneous) clinical trials.

B. Non-chromosome 4q families; large enough to allow linkage analysis and gene

isolation. Identification of a second FSHD gene should greatly facilitate the identification of crucial (rate-limiting) molecular pathways. This might help direct our

thinking on (gene) therapy.

C. Large scale profiling of thousands of components to identify molecular pathways leading to FSHD and targets amenable for intervention. Attention should be

given to; 1. RNA (transciptomics). RNA reflects the steady-state transcription situation, but might be only a meager reflection of the true (patho)biology. This work is

ongoing in several centers; 2. Protein (proteomics). The protein components reflect

the real biological executive situation. Proteomics is much more complicated than
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transcriptomics, but may give much more information; 3. Metabolites

(metabolomics). In the near future, we will have technologies at our disposal to identify and quantify metabolites, the individual steps (substrates) of metabolic pathways. These compounds may crucially determine the actual pathology and phenotype.

D. Cellular and animal models. It is very likely that the generation of cellular and

animal models will be pivotal, not only for the generation of therapeutic means, but

also to help identifying the molecular basis of FSHD itself. In all likelihood, several

approaches have to be followed; 1. Transgenic mouse models. Two different approaches can be envisaged: models for individual candidate genes, identified in the

chromosome 4q region or elsewhere and general models in which large genomic regions of chromosome 4q and chromosome 10q, including the telomeres are transferred and integrated, preferably at mouse telomeres. These latter models will approximate the human situation and allow studies on the cause and consequences of

the inter- and intra-chromosomal interactions and rearrangements in relation to

FSHD; 2. Other animal models. For specific questions on position effects variegation

etc., simpler models, like Drosophilia, and yeast may be very useful.

E. Chromatin structure in and adjacent to the region where the FSHD deletions

occur. Including; 1. factors predisposing to illegitimate recombination; 2. abnormally

expressed genes in FSHD.

F. Better understanding of abnormalities of the small blood vessels of the retina

at the back of the eye in FSHD patients. Including; 1. why children with a more

severe or even sporadic form of FSHD are more likely to develop this symptomatic

form of retinal disease; 2. an unidentified additional genetic peculiarity which renders some FSH individuals peculiarly susceptible to symptomatic retinal disease; 3.

whether retinal, cochlear and skeletal muscle abnormalities in FSH represent different effects of the same mutation or otherwise are the results of abnormalities of

adjacent genes; 4. the possibility that such pleitropic effects are mediated by inflammation and/or ‘‘environmental’’ factors.

G. Clinical, molecular genetic study and genotype/phenotype correlation of

facioscapulohumeral muscular dystrophy phenotype and facioscapuloperoneal muscular dystrophy phenotype.

H. Clinical trials. It is likely that new clinical trials will be launched on basis of

hints in other (muscular) disorders. Access to well characterized (e.g. with respect

to clinical phenotype and genetic constitution) patients cohorts is crucial for proper

evaluation.

I. Molecular pathway based therapy. Increasing insight in the molecular pathways

of FSHD, already available and hopefully even more so in the near future, will form

the rationale for novel treatment strategies. It is difficult to predict whether these

efforts will be DNA-based or pharmacological. In any case, such experimental approaches have to be developed in (transgenic) animal models; another argument for

investing in versatile models.

The NIH has the tremendous capacity to quickly enhance research in the above

project areas through its intramural and extramural research programs. The FSH

Society and Congress have been repeatedly informed that the NIAMS has invested

considerable resources into the newly formed Laboratory of Physical Biology (LPB)

at the NIAMS to strengthen its intramural program on muscle diseases and in

FSHD muscular dystrophy research. The LPB mission is to study of biological systems using leading-edge physical approaches, and muscle contraction, regulation,

structure, and function. The NINDS also has a considerable resource to offer with

its intramural research staff and programs. Additionally, the NINDS and NIAMS

staff are currently consulting with members of the extramural community to build

a research portfolio on FSHD. This year should bring a concerted effort by the NIH

NINDS/NIAMS, the National Institute for Human Genome Research (NIGHR) and

its NIH Intramural Sequencing Center (NISC) to accelerate extramural research by

offering and bridging intramural resources with the extramural community of researchers and clinicians thereby making the above research viable. The NIH has

begun to make great progress in its extramural programs covering FSHD and the

immediate proactive inclusion of intramural resources and programs will help rapidly accelerate solutions and understanding of FSHD.

On November 8, 2000, the first of the three major announcements was made by

NIH as ‘‘Exploratory Research on Facioscapulohumeral Muscular Dystrophy’’. On

December 11, 2000, the second announcement was made on the establishment of a

National Patient Registry at the University of Rochester Medical School for FSHD

and Myotonic muscular dystrophy. On January 4, 2001, the third announcement

was made for a three year program ‘‘Therapeutic and Pathogenic Approaches for the

Muscular Dystrophies.’’
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We are delighted with these steps towards finding solutions for FSHD. We note

with cautious optimism that the NIH has begun the process to establish a portfolio

in the causes and treatment of FSHD as called for in the past three years of House

and Senate Report Language. However, we are only beginning the process. Difficult

work lies ahead involving establishing population databases, developing research resources such as a mouse model, understanding the molecular process, understanding tissue changes, the development and clinical trials of possible therapies

and population based studies.

Mr. Chairman, we are watching with interest the response of the scientific community to the announcements of NIH referenced above. We are concerned that, despite these announcements, the exciting scientific questions about this disease and

progress in genomics and the tremendous need of patients for therapies, that the

response of the scientific community will be less than optimal. We hope we are

wrong. We are concerned that there is not an attitude of confidence that FSHD,

muscular dystrophy or muscle biology is of significant importance at NIH over the

long term to justify the investment by researchers in this field. After all it has taken

the FSH Society since 1994 to encourage Congress and NIH to move this far, we

feel the Committee should consider earmarking funding in this area sufficient to encourage researchers to make a commitment to pursue this difficult and often frustrating area of investigation.

We request that the Committee consider earmarking an amount of not less than

fifteen (15) million dollars for FSHD research.

The men, women and children who live with the daily consequences of this devastating disease are your friends, neighbors, fellow taxpayers and contributors to

the American way of life. With an historic 88 percent employment rate and an average educational achievement level of 14 years, we personally bear our burden of the

health care costs and training expenses to prepare for and maintain financial and

personal independence. We appeal to you today to take our hard earned tax dollars

commensurate with our numbers and valuable contributions to American Society

and we urge the United States Government to allocate a proportion of our tax burden toward research on FSHD.

Mr. Chairman, we trust your judgement on the matter before us. Please remember, we need your help to ensure that the sun is rising on FSHD and all other muscular dystrophies.

Mr. Chairman, again, thank you for providing this opportunity to testify before

your Subcommittee.

PREPARED STATEMENT OF THE FOUNDATION FOR ICHTHYOSIS & RELATED SKIN TYPES

Mr. Chairman and members of the Subcommittee: The Foundation for Ichthyosis

& Related Skin Types (F.I.R.S.T.) wishes to thank the members of this subcommittee for your past support of the National Institutes of Health (NIH) and the

National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS). We appreciate the opportunity to provide written testimony regarding funding for skin disease research and the budget for NIAMS. F.I.R.S.T. is requesting that the budget

for the NIH/NIAMS be increased by 16.5 percent, which will keep the NIH on track

to doubling the budget by fiscal year 2003.

In 1992 a member of F.I.R.S.T. testified before this committee regarding the need

for a national registry for ichthyosis and related disorders. Today, as a direct result

of your interest and support, we have the National Registry for Ichthyosis and Related Disorders. The Registry’s funding was just renewed for another four years and

was expanded to include molecular diagnosis. The registry helps generate researcher interest in ichthyosis, and provides investigators with an essential tool—

a pool of affected individuals with a confirmed clinical diagnosis. The availability

of this pool of information results in significant savings in research time and dollars,

which would have normally been spent identifying eligible patient populations.

F.I.R.S.T. is a voluntary organization dedicated to providing support, information,

education and advocacy for individuals and families affected by ichthyosis. F.I.R.S.T.

supports research into causes, treatment and a cure for ichthyosis.

Ichthyosis is a family of genetic skin diseases characterized by dry, thickened,

scaling skin. These diseases are caused by genetic defects that are usually the result

of genetic inheritance. Currently, there is no cure for ichthyosis, and there are no

truly effective treatments.

Some forms of ichthyosis cause the skin to be very fragile and blister easily. Scaling and flaking are continuous. The skin is tight and cracked. The palms and soles

can be thick, making something as simple as holding a pencil or as natural as walk-
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ing difficult and painful. Overheating is dangerous and infections are a constant

threat.

Our children are sometimes hospitalized for infections. Simple medical procedures

are complicated. Days and activities are planned around skin care. Stares and questions from strangers are common. While the physical aspects of ichthyosis are obvious, the blows to ones self-esteem can be even more damaging. Currently, ichthyosis

is a life-long battle. Hopefully, this will change in the future.

We recognize this Subcommittee’s strong history of bipartisan support for medical

research funding and the NIH. Recently new genes have been discovered for several

types of ichthyosis and related skin types. Darier’s disease, although not strictly an

ichthyosis, was found to be caused by mutations involving the ATP2A2 gene. Another ATPase gene, ATP2C1, encoding another calcium pump was found this year

to be the cause of Hailey-Hailey disease. Patients with this condition have more

problems with blistering, but lesser problems with scaly skin than patients with

Darier’s disease.

Two new genetic defects affecting the synthesis of cholesterol have now been

linked to ichthyosis. The affected enzymes, sterol 4 demethylase and sterol 7,8

isomerase, were first shown to cause ichthyosis-like conditions in laboratory mice.

Cholesterol is an essential component of the plasma membrane that surrounds each

cell, and also of the membranes lying between the cells of the stratum corneum. In

these outer skin layers, cholesterol acts to prevent too much evaporative loss of

water from the interior of the body to the drier atmosphere. Subsequently, several

patients with the Conradi-Hunermann-Happle syndrome, a condition that affects

only females and causes an ichthyosiform erythroderma in a swirling pattern during

infancy, along with abnormalities affecting the eye, bones and other tissues, have

mutations in the gene for sterol 7,8 isomerase. And patients with CHILD syndrome,

a condition also only affecting females in a pattern of abnormalities but is limited

to only one side of the body, have had mutations affecting the sterol 4 demethylase

in some cases and the sterol 7,8 isomerase in others.

Several new causes of palmar plantar keratoderma (PPK) (thickened outer skin

mostly restricted to palms and soles) were identified this past year. Striate PPK

(bands of thickened skin along the digits) was linked to mutations affecting two proteins, desmoglein I and desmoplakin, that are constituents of desmosomes. Papillon

Lefevre syndrome is a palmar plantar keratoderma with severe periodontitis (inflammation of the gums). This condition was found to be due deficiency of a protease

(enzyme that digests proteins), Cathepsin. The last of the genetic breakthroughs

this past year were the identification of connexin gene mutations in two scaling skin

disorders. One of the skin diseases caused by a connexin mutation (connexin 31 protein, encoded by the gap junction protein beta-3 gene) is Erythrokeratodermia

vanablis. Not all patients with EKV have been found to have mutations in this gene,

implying that other genes may cause the same disease pattern. Also patients with

different mutations in this same gene do not have skin disease, but instead are deaf.

Mutations affecting another connexin, Connexin 26, also cause deafness and some

of these patients, in addition to deafness, have Vohwinkel’s PPK.

We are excited about this progress, and about the current research into gene therapy. We are hopeful about the possibility for an effective treatment or cure on the

horizon, but at this point it is still just hope. We continue to be frustrated by the

lack of effective treatment options.

Three years ago, this country embarked on a commitment to double the National

Institutes of Health (NIH) budget in five years. F.I.R.S.T. requests that funding to

the NIH continually be increased to stay on track with that plan. It is very important to support this initiative because the NIH is where most of the country’s important research originates. Research that involves any new discovery for any skin disease is beneficial to all skin diseases. Since skin diseases are so closely related,

eventually these advancements will filter across the board and possibly lead to discoveries in our particular disease, ichthyosis. It is critical for fundamental research

to be continued as well. Even though each particular skin disease group wants their

particular disease to be the focus of increased research, it is difficult to study any

of these diseases if the basic function of skin cells is not mastered.

Last year, Congress passed the Clinical Enhancement Act to provide a loan repayment program for medical school graduates. F.I.R.S.T. asks that funding for this

program be supported and increased.

Young doctors are faced with enormous medical school loans after graduation. Because of this debt, many young doctors choose professions that provide higher salaries, which will help them reduce their debt quicker. By supporting and increasing

funding for the Clinical Enhancement Act, this program will become stronger and

encourage young doctors to choose a career path in research. F.I.R.S.T. also requests
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that federal appropriators support funding for a workshop to study and record the

current yearly medical costs related to skin diseases in this country.

If the NIH is to unlock the mysteries of disease, translate the recent research discoveries into new treatments for the bedside, it is necessary that the appropriation

for the NIH be a sizable, sustained and stable effort. We hope that you will keep

the faith with your constituents, and provide the needed funds to the NIH.

On behalf of our members, those with ichthyosis and their families, we thank this

Congressional Subcommittee for their time and attention.

PREPARED STATEMENT OF FAMILIES OF SPINAL MUSCULAR ATROPHY

Mr. Chairman and members of the Senate Appropriations Subcommittee on

Labor, HHS, Education and Related Agencies, Families of Spinal Muscular Atrophy

wishes to thank you for this opportunity to submit written testimony for the record.

Mr. Chairman and Members of the Subcommittee, let me begin by asking a question, what would you do if you were told your 10-week-old son or daughter would

not live to see his/her second birthday? Or, if your child were beginning to walk,

and then for some reason, unknown to you, regressed to only crawling then eventually only sitting? For families who have a child diagnosed with Spinal Muscular Atrophy these are not hypothetical questions, these are real situations faced everyday.

Spinal Muscular Atrophy (SMA) is the number one genetic killer of children under

the age of two. SMA is a vicious, debilitating genetic disease that affects individuals

indiscriminately and is more widespread than anyone realizes. One in every forty

people carries the gene that causes SMA and one in every 6,000 babies is born with

SMA. Due to the various forms of SMA, the disease onset can be at any age.

SMA is a neuromuscular disease that affects the anterior horn cells. Through

great collaborative effort the scientific field has identified the gene that causes SMA

as well as determined the missing protein and are well on their way to replacing

it. By replacing this missing protein it is hopeful that the disease will be eradicated

and that some damage might be repaired. With this knowledge and additional National Institutes of Health (NIH) funding through the National Institute of Neurological Disease and Stroke (NINDS), this information will not only lead to a cure

for SMA, but will also open doors through this new technology to be used for other

motor neuron and neuromuscular diseases.

Families of S.M.A is a 100 percent volunteer organization whose mission is to

fund research, support families and create awareness. Through the efforts of Families of S.M.A. scientists from all over the world meet once a year to discuss and

share the progress made in research. Most recently we have asked that NINDS explore areas of promising research, which were identified at the 2000 Families of

SMA International Workshop. This includes the development of a SMA basic and

clinical research portfolio through all available mechanisms, as appropriate, including clinical trails of drug compounds capable of activating SMN2 expression.

We wish to thank NINDS for their support in the Multi-Center Creatine Study,

but the continued development of a SMA research portfolio is critical. In the very

near future SMA will be involved in drug development and/or stem cell therapy or

gene replacement therapy. The participation of NINDS in this endeavor is most important. We ask the committee to encourage NINDS to explore areas which will be

identified at the 2001 Families of S.M.A. International Workshop which is being

held in June.

Mr. Chairman, on behalf of all the individuals suffering from the various forms

of SMA, thank you for your continued, strong leadership for the bipartisan effort

to double the NIH budget over five years. Providing the NIH with a $3.4 billion increase in funding this year is critical to individuals with SMA.

Thank you.

FACT SHEET ABOUT SPINAL MUSCULAR ATROPHY (SMA)

The Disease

Spinal muscular atrophy (SMA), the number one genetic killer of children under

the age of two, is a group of inherited and often fatal diseases that destroys the

nerves controlling voluntary muscle movement, which affects crawling, walking,

head and neck control, and even swallowing.

Who is Affected

SMA is one of the most prevalent genetic disorders.

—One in every 6,000 babies is born with SMA. Of children diagnosed before age

two, 50 percent will die before their second birthday.

—SMA can strike anyone of any age, race or gender.
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—One in every 40 people carries the gene that causes SMA. The child of two carriers has a one in four chance of developing SMA.

Types of SMA

—Type I, or Werdnig-Hoffman Disease, is the most severe form of SMA. Children

with Type I tend to be weak and lack motor development, rendering movement

difficult. Children afflicted with Type I cannot sit unaided and have trouble

breathing, sucking and swallowing. Type I SMA strikes infants between birth

and six months.

—Type II, is slightly less severe. Type II patients may be able to sit unaided or

even stand with support and usually do not suffer from feeding and swallowing

difficulties. However, they are at increased risk for complications from respiratory infections. Type II SMA affects infants between seven and eighteen

months old.

—Type III, also known as Kugelbert-Welander Disease, is the least deadly form

of childhood-onset SMA. Type III patients are able to stand, but weakness is

prevalent and tends to eventually sentence its victims to a wheelchair. Type III

SMA strikes children after the age of eighteen months, but can surface even in

adulthood.

—Type IV, is the adult form of the disease in which symptoms tend to begin after

age 35. Symptoms usually begin in the hands, feet and tongue, and spread to

other areas of the body.

—Adult Onset X-Linked SMA, also known as Kennedy’s Syndrome or Bulbo-Spinal Muscular Atrophy, occurs only in men. Facial and tongue muscles are noticeably affected. Like all forms of SMA, the course of the disease is variable,

but in general tends to progress slowly.

SMA does not affect sensation and intellectual activity in patients. It commonly

is observed that patients with SMA are unusually bright and sociable.

Testing

Prenatal counseling is available to couples who are carriers of SMA or who have

lost a child to SMA.

PREPARED STATEMENT OF THE HEPATITIS FOUNDATION INTERNATIONAL

Chairman Specter and members of the Committee. I am Thelma King Thiel,

Chairman and Chief Executive Officer of the Hepatitis Foundation International

(HFI), representing the Board of Directors and members of 425 patient support

groups across the nation, the majority of whom suffer from chronic viral hepatitis.

We commend the Committee for allocating initial funds that have enabled CDC

to make tremendous strides in efforts to understand hepatitis and to control it

through universal immunization and education programs.

Although all five types of viral hepatitis are preventable, we are currently dealing

with an ‘‘epidemic of discovery’’, people who are already infected with the hepatitis

C virus because of lack of information about transmission, appropriate vaccines and

effective treatments to stop the spread to others. Hepatitis B has been eclipsed by

hepatitis C even though we have effective tools to eradicate hepatitis B. Lack of

funds and integrated prevention activities contribute to the ongoing transmission of

hepatitis B that claims 5,000 lives each year. If high risk individuals who attended

STD clinics, or those who have been incarcerated had been vaccinated against hepatitis B in the early 1980s when the vaccine was approved, we would not be dealing

with the large numbers of individuals who are chronically infected and in need of

liver transplants today. It is time to make a major investment in immunization and

preventive education to bring these diseases under control. All newborns, young

children, young adults, and especially those who participate in high-risk behaviors

must be a priority for immunization initiatives. We need to provide effective preventive education in our elementary and secondary schools to help children avoid the

ravages of health problems resulting from viral hepatitis infection.

The Hepatitis Foundation International has worked closely with the Centers for

Disease Control and Prevention through cooperative agreements in addition to contributing private funds for specific projects. HFI provided significant independent

support and co-sponsored the Hepatitis C Teleconference for healthcare providers in

1997. Collaboration with CDC has enabled the Foundation to develop and distribute

thousands of award winning videos and innovative, effective educational materials

nationwide dealing with liver wellness, hepatitis and substance abuse prevention.

Many of these items are available in several languages. Teachers, healthcare providers, public health officials, personnel in corrections and juvenile detention centers, governmental and non-governmental agencies all need these tools. Funding is
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needed to duplicate and distribute many more to those on the front line in the battle

against hepatitis and substance abuse.

Prevention can save lives today. We need to train health care professionals in effective communication and counseling techniques. We need public awareness campaigns to alert individuals to assess their own risk behaviors. We need to motivate

them to seek medical advice . . . to encourage them to be immunized against hepatitis A and B . . . and to stop drinking any alcohol if they have participated in risky

behaviors that may have exposed them to hepatitis C.

Mechanisms are in place to provide screening, referral services, medical management, counseling, and prevention education for those who have HIV/AIDS. Funds

must be made available to expand all of these services, including immunization, to

those who are infected by hepatitis viruses. HFI recommends an increase of $15 million for further implementation of CDC’s

Hepatitis C Prevention Strategy. This increase will further the development of

state-based prevention programs by increasing the number of state health departments with CDC funded coordinators from 16 to 51 covering each state and by implementing demonstration projects to evaluate ways to integrate hepatitis C and

hepatitis B prevention efforts into existing public health programs. HFI recommends

that $10 million be added to CDC’s budget to train and maintain hepatitis coordinators in every state to implement prevention and management strategies.

The CDC Prevention Research Centers Program plays a critical role in reducing

the human and economic costs of disease. CDC should be commended for its decision

to fund the most meritorious applications in the fiscal year 2001 competition, regardless of geographic location of the applicants with respect to other Prevention

Research Centers. Preventive education is cost effective. CDC estimates that for

every $1 spent on school-based drug and alcohol, tobacco, and sexuality education,

$14 are saved in avoided health care costs.

CDC currently funds 24 prevention research centers at schools of public health

and schools of medicine across the country. An additional two centers will be selected using a portion of the $23 million the Congress dedicated to the program in

fiscal year 2001. However, core funding for prevention centers has been decreasing

since this program was first funded in 1986 from an average of $800,000 per center

to $580,000 in fiscal year 2000.

In order to continue to build this flagship CDC extramural research program, HFI requests Congress to increase the core funding to $40 million for Prevention Research Centers in fiscal year 2002.

Past investment in NIH has led to an explosion of knowledge that has advanced

understanding of the biological basis of disease and development of strategies for

disease prevention diagnosis, treatment, and cures. Countless medical advances

have resulted in a direct benefit to the lives of all Americans. NIH-supported scientists remain our best hope for sustaining the momentum in the pursuit of scientific opportunities and new health challenges. Research studies to learn why some

HCV infected individuals resolve their infection spontaneously may prove to be life

saving information for many who are currently infected. The answer may provide

a cure for others.

To achieve the proposed doubling of the NIH budget over the five-year period from

fiscal year 1999 to fiscal year 2003, the Hepatitis Foundation International joins

with Congress and the new Administration in supporting an appropriation of $23.7

billion for NIH in fiscal year 2002 representing a 16.5 percent increase. HFI also

recommends a comparable increase of 16.5 percent in hepatitis research funding at

the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Allergy and Infectious Diseases. An additional $4 million is needed to extend and expand the HALT–C to study the pathogenesis and treatment of

hepatitis C and to understand why some patients respond to treatment and others

do not.

A significant portion of increases for these Institutes should be earmarked to conduct studies among groups of patients that have been neglected in overall research

initiatives. They include:

—African Americans—to identify reason why they do not respond to antiviral

agents in the treatment of chronic hepatitis C.

—Children and Adolescents—Pediatric liver research lacks appropriate funding to

address the many diseases, including viral hepatitis, that affect children.

—Renal Dialysis Patients—Many are HCV infected and outcomes of treatment

need more investigation.

—HIV/HCV Positive Patients—Co-infections need special investigation

—Hemophilia Patients—Co-infection with HIV needs further study.

Victims of hepatitis suffer emotionally as well as physically. They experience discrimination in employment, strained personal relationships and severe depression
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when treatments fail to control their illness as well as during their treatment. We

look forward to working in collaboration with CDC, NIH, health departments and

other voluntary organizations to bring viral hepatitis under control.

I would be happy to answer any questions you may have. Thank you for providing

this opportunity to present our testimony.

PREPARED STATEMENT OF THE HUMANE SOCIETY OF THE UNITED STATES

We appreciate the opportunity to provide testimony to the Labor, Health and

Human Services, and Education Subcommittee on two funding items of great importance to The Humane Society of the United States (HSUS) and its 7.7 million supporters nationwide. As the largest animal protection organization in the country,

The HSUS urges the Committee to address these priority issues in the fiscal year

2002 budget: —$6 million for planning and construction to launch the national chimpanzee

sanctuary system authorized by Public Law 106–551; —$3 million to expand the work of the Interagency Coordinating Committee for

the Validation of Alternative Methods (ICCVAM), authorized by Public Law

106–545, coupled with Committee Report language encouraging federal agencies

to avail themselves of ICCVAM’s expertise and efficient review process.

CHIMPANZEE SANCTUARIES

We are very pleased that Congress last year enacted H.R. 3514 (Public Law 106–

551), the Chimpanzee Health Improvement, Maintenance, and Protection Act, which

authorized up to $30 million to establish and operate a federal chimpanzee sanctuary system for chimpanzees no longer used in medical research. Introduced by

Senators Bob Smith (R-NH) and Richard Durbin (D-IL) and Representative Jim

Greenwood (R-PA), this legislation earned the bipartisan support of 24 cosponsors

in the Senate and 143 cosponsors in the House. It had the endorsement of more

than 100 scientists, many of whom are renowned experts in the field of chimpanzee

research. The legislation was approved by unanimous voice vote in both chambers

and was signed into law on December 20, 2000.

This common-sense statute is designed to help animals who are deemed by the

Secretary of Health and Human Services to be ‘‘surplus’’ for medical research, but

who are still being warehoused in expensive federally-supported laboratory cages.

As determined by the Congressional Budget Office (CBO), the sanctuaries envisioned by this law will provide a much higher quality of life for these animals. They

will also serve American taxpayers well, by saving millions of dollars over the

course of the next several years ($4 million annually, after initial construction

costs). These savings are primarily due to the fact that sanctuary facilities, which

offer a more naturalistic environment and opportunities for social interaction, can

be built and operated at significantly lower cost than laboratory facilities. Housing

chimpanzees in sanctuaries is estimated to cost $8–$15 per day per animal, compared to the $20–$30 per day per animal that the federal government currently

spends to house them in lab cages. In addition, the statute creates a public-private

partnership, requiring private sector matching dollars to complement the federal

government’s share (the private match is 10 percent of construction costs and 25

percent of operating costs).

The statute follows the recommendations of a National Research Council (NRC)

report commissioned by the National Institutes of Health (NIH) and released in

1997, ‘‘Chimpanzees in Research: Strategies for Their Ethical Care, Management,

and Use.’’ In 1986, NIH launched an initiative to breed chimpanzees—mistakenly

thought to be useful models for AIDS research—creating a surplus of several hundred chimpanzees who are no longer used in medical research. According to the

NRC report, the government is spending more than $7 million annually on maintenance of chimpanzees. The report recommends a breeding moratorium and opposes

euthanasia of chimpanzees as a means of population control, noting that ‘‘[s]ome of

the best and most caring members of the support staff, such as veterinarians and

technicians would, for personal and emotional reasons, find it impossible to function

effectively in an atmosphere in which euthanasia is a general policy, and might resign.’’ The report also specifically recommends: ‘‘The concept of sanctuaries capable

of providing for the long-term care and well-being of chimpanzees that are no longer

needed for research and breeding should become an integral component of the strategic plan to achieve the best and most cost-effective solutions to the current dilemma.’’

To implement this law in a timely and efficient way, we respectfully request that

the Committee direct NIH to allocate $6 million in fiscal year 2002 for planning and
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construction of the national chimpanzee sanctuary system. In recognition of budget

constraints, this requested funding level falls well below the $11 million outlays

that CBO projected for the first year of the system. But we believe it is enough to

ensure that implementation will move forward quickly, so that the chimpanzees and

taxpayers can begin to benefit as Congress intended.

INTERAGENCY COORDINATING COMMITTEE FOR THE VALIDATION OF ALTERNATIVE

METHODS (ICCVAM)

We are also very pleased that Congress enacted H.R. 4281 (Public Law 106–545)

last year by unanimous voice vote in both chambers. This legislation, introduced by

Senator Mike DeWine (R-OH) and Representatives Ken Calvert (R-CA) and Tom

Lantos (D-CA), earned the bipartisan support of 5 Senate cosponsors and 73 House

cosponsors, and was signed into law on December 19, 2000. This statute strengthens

and makes permanent the Interagency Coordinating Committee for the Validation

of Alternative Methods (ICCVAM). We hope the statute will increase acceptance of

more animal-friendly test methods by streamlining the process by which these

methods are validated and easing institutional barriers within federal agencies that

discourage their use.

ICCVAM performs an invaluable function for regulatory agencies, industry, public

health, and animal protection organizations by assessing the validation of new, revised and alternative toxicological test methods that have interagency application—

including methods that replace, reduce, and refine the use of animals in testing.

After appropriate independent peer review of a test method, ICCVAM provides its

assessment of the test to the federal agencies that regulate the particular endpoint

that the test measures. In turn, the federal agencies maintain their authority to incorporate the validated test method as appropriate for the agencies’ regulatory mandates. This streamlined approach to assessment of validation of new, revised and

alternative test methods has reduced the regulatory burden of individual agencies,

provided ‘‘one-stop shopping’’ for industry, animal protection, public health and environmental advocates to consider test methods, and set uniform criteria for what constitutes a validated test method.

ICCVAM arose from an initial mandate in the NIH Revitalization Act of 1993 for

the National Institute of Environmental Health Sciences (NIEHS) to ‘‘(a) establish

criteria for the validation and regulatory acceptance of alternative testing methods,

and (b) recommend a process through which scientifically validated alternative

methods can be accepted for regulatory use.’’ In 1994, NIEHS established an ad hoc

ICCVAM to write a report that would recommend criteria and processes for validation and regulatory acceptance of toxicological testing methods that would be useful

to federal agencies and the scientific community. Through a series of public meetings, interested stakeholders and agency representatives from 14 regulatory and research agencies developed NIH Publication No. 97–3981, ‘‘Validation and Regulatory

Acceptance of Toxicological Test Methods.’’ This report has become the ‘‘sound

science’’ guide for consideration of new, revised and alternative test methods by the

federal agencies and interested stakeholders. After publication of the report, the ad

hoc ICCVAM moved to standing status under the NIEHS’ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods

(NICEATM). Representatives from federal regulatory and research agencies have

continued to meet, with advice from NICEATM’s Advisory Committee and independent peer review committees, to assess the validation of new, revised and alternative toxicological test methods.

Since then, two methods have undergone rigorous assessment and been deemed

scientifically valid and acceptable. The first method, Corrositex, is a replacement for

animal-based dermal corrosivity tests for some chemicals. The second, the Local

Lymph Node Assay, is a reduction and refinement of an animal test for the skin

irritation endpoint.

The open public comment process, input by interested stakeholders, and the continued commitment by various federal agencies have led to ICCVAM’s success so

far. Now, with enactment of Public Law 106–545, ICCVAM is poised to accomplish

even more in terms of streamlining the validation of other new, revised and alternative test methods. For the past few years, NIEHS has provided approximately $1

million annually to NICEATM for ICCVAM activities. In order to ensure that federal regulatory agencies and their stakeholders can more fully benefit from the work

of ICCVAM, we respectfully urge the Committee to direct NIEHS to allocate $3 million for ICCVAM activities in fiscal year 2002. Funding at this level will cover FTEs,

independent peer review assessment of test methods, meeting expenses, and other

activities as deemed appropriate by the Director of the NIEHS. In addition, we respectfully request inclusion of the following Committee Report language:
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‘‘The Committee directs that $3 million from the National Institute of Environmental Health Sciences budget be allocated to the National Toxicology Program’s

Interagency Center for the Evaluation of Alternative Toxicological Test Methods for

Interagency Coordinating Committee for the Validation of Alternative Methods

(ICCVAM) activities during fiscal year 2002. The Committee supports the assessment of scientific validation of new, revised and alternative toxicological test methods by the ICCVAM. The Committee directs the regulatory and research agencies,

including, but not limited to, the National Institute of Environmental Health

Sciences, Food and Drug Administration and Environmental Protection Agency, to

use the expertise and credibility of the ICCVAM for these assessments to streamline

their individual consideration of new, revised and alternative toxicological test

methods. The Committee also urges the federal regulatory and research agencies to

incorporate scientifically validated new, revised and alternative test methods into

their regulations, requirements and recommendations in an expeditious manner.’’

Again, we appreciate the opportunity to share our views and priorities for the

Labor, Health and Human Services, and Education Appropriation Act of fiscal year

2002. We hope the Committee will be able to accommodate these two requests affecting animals across the United States. Thank you for your consideration.

PREPARED STATEMENT OF THE HUNTINGTON’S DISEASE SOCIETY OF AMERICA

SUMMARY OF RECOMMENDATIONS

The Huntington’s Disease Society of America (‘‘HDSA’’) urges Congress to increase

funding for medical research on neurodegenerative diseases and disorders, especially Huntington’s Disease (‘‘HD’’), through budgetary increases to the National Institutes of Health (‘‘NIH’’).

Specifically, HSDA encourages Congress to provide at least a 16.5 percent increase over fiscal year 2001 for NIH, raising the funding levels from $20.3 billion

to $23.7 billion, as recommended by the Ad Hoc Group for Medical Research Funding. Within NIH, HDSA recommends at least a commensurate increase for the National Institute of Neurological Disorders and Stroke (‘‘NINDS’’), the National Institute of Mental Health (‘‘NIMH’’), and the National Institute on Aging (‘‘NIA’’), each

of which support a modest portfolio of HD research. These increases would allow

for further research on the diagnosis, treatment and cure for HD, a debilitating and

devastating neurodegenerative disease.

HUNTINGTON’S DISEASE SOCIETY OF AMERICA

HDSA is a national voluntary non-profit health organization dedicated to finding

a cure for Huntington’s Disease while providing services and support for those living

with HD and their families. Founded in 1967, HDSA promotes and supports both

basic and clinical HD research, aids families throughout the continuum of HD, and

educates the public and healthcare professionals about HD.

Private donations coupled with the tireless fundraising efforts of HDSA chapters

around the country make the HDSA Research Grants program possible. These

grants help innovative research projects develop sufficiently to attract funding from

other sources, particularly the NIH, which do not provide funds for projects in their

early stages of development.

HUNTINGTON’S DISEASE

HD is an inherited degenerative brain disorder that results in the loss of both

mental faculties and physical control. It is caused by the mutation of a single gene.

The disease afflicts approximately 30,000 Americans, while 150,000–200,000 Americans are at-risk of inheriting it from a parent. Each child of a parent with the HD

gene has a 50/50 chance of inheriting the disease. Every person who inherits the

HD gene will eventually develop the disease. HD does not skip generations; if one

does not inherit the gene, one cannot pass it on. HD affects as many people as

Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) or Cystic Fibrosis.

Symptoms of HD may affect cognitive ability or mobility and include depression,

mood swings, forgetfulness, clumsiness, involuntary twitching and lack of coordination. As the disease progresses, concentration and short-term memory diminish and

involuntary movements of the head, trunk and limbs increase. Walking, speaking

and swallowing abilities deteriorate. Eventually the person is unable to care for him

or herself. Death often results from complications such as choking, infection or heart

failure.
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The costs to society are both direct and indirect, and include medical expenses,

loss of productivity in the workplace by patients and caregivers (oftentimes spouses

or children), disability claims, and long-term care expenses. On an annual basis, the

direct and indirect costs of HD to society total over $2 billion.

RESEARCH RECOMMENDATIONS

Once thought of as a rare disease, HD is now considered to be one of the more

common hereditary diseases. Although HD is classified as a more common hereditary disease, researchers have yet to discover an effective treatment to slow the progression of HD or a cure for this deadly disease. Over the past decade, there have

been breakthroughs in HD research and researchers continue to aggressively build

upon these advancements. The outlook for treating and curing HD has never been

more promising.

In 1993, researchers identified the gene that causes HD. Such a discovery has

made possible a predictive test for HD. Individuals at-risk for HD can now find out

whether they carry the gene before symptoms arise. This discovery has been a

springboard for laboratory research. It has led to the creation of a mouse model of

Huntington’s Disease, referred to as a ‘‘transgenic’’ mouse. The HD gene is inserted

into mouse DNA, thus causing the mouse to develop HD symptoms. Using

transgenic mouse models, researchers have identified and characterized pathogenic

hallmarks; the aberrant events that occur in the brain cells of the subjects with HD.

In an effort to transform basic research data and determine how it can be applied

to treat or cure HD in humans, clinical trials must be established. Patients with

HD and their families are desperately depending on the positive outcomes of these

clinical trials to improve their quality of life. However, prior to commencement of

clinical trials, researchers must employ the technology of high throughput screens

for drug development. This technique rapidly tests a very large number of compounds to see if they have a desired positive effect. Compounds that have a positive

effect then go through more research to determine if they could become a viable

drug therapy for human clinical trials.

HDSA appreciates the commitment that Congress has made to double the NIH

budget by fiscal year 2003. Medical research endeavors and America’s patients are

benefiting tremendously from this five-year effort. This initiative will pay dividends

for decades to come. However, despite the fact that HD is considered one of the

more common hereditary disease, the NIH Office of Budget estimates that only onethird of 1 percent of NIH’s sizeable $20.3 billion budget will be dedicated to HD research in fiscal year 2001. The level of NIH resources allocated to HD research is

inadequate, especially considering the recent substantial increases in the NIH budget. NIH must elevate the priority level of HD research.

HDSA recommends that Congress urge the NINDS, NIMH, and NIA to increase

RO1 funding for HD and other neurodegeneration research by 15 percent for fiscal

year 2002. Using such an increase in resources, researchers will develop more models of HD, including fruit fly models and worm models, and will test compounds and

genes which may ameliorate or prevent HD. Additionally, researchers hope to target

the aberrant events that occur in brain cells of subjects with HD and test approaches to prevent or mitigate these adverse occurrences.

HD serves as a prototype disease caused by the mutation of a single gene. Therefore, advances made in the understanding and treatment of HD will increase scientists’ ability to derive the mechanism and therapeutic approaches for several similar diseases, including Alzheimer’s Disease, ALS and Parkinson’s Disease.

CONCLUSION

HD continues to take a huge emotional and financial toll on America’s families.

HDSA appreciates Congress’ commitment to biomedical research and to the NIH in

recent years. However, more effort is needed. Congress must maintain the momentum, and in some cases, devote even more resources. HDSA is grateful for the opportunity to present its views on fiscal year 2002 appropriations. Please contact Barbara Boyle, HDSA National Executive Director/CEO, at (212) 242–1968, if you have

further questions.

PREPARED STATEMENT OF THE IMMUNE DEFICIENCY FOUNDATION

Mr. Chairman, thank you for the opportunity to submit testimony on primary immune deficiency disorders and the need for continued research and education on

these diseases.
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Primary immune deficiency diseases are inherited disorders in which parts of the

body’s immune system are missing or do not function properly. The World Health

Organization has identified more than 70 different primary immunodeficiency diseases. These disorders are very under diagnosed, but we believe that more than

45,000 Americans, of all races, ages, and gender. Fortunately, most primary immune

deficient patients, once diagnosed, are able to maintain their health through infusions of a pooled plasma derivative known as intravenous immuneglobulin (IGIV)

every three to four weeks for the rest of their life. However, if primary immunodeficiency diseases are not properly diagnosed and treated, they can lead to serious

illness and early death.

The Immune Deficiency Foundation (IDF) is the national non-profit, charitable organization dedicated to improving the health of primary immune deficient patients

through research and education. Headquartered in Towson, Maryland, IDF was

founded in 1980 by a group of parents of primary immune deficient children who

wanted to focus attention on the needs of primary immune deficient patients, physicians, and researchers.

IDF provides a wide variety of patient and family services, medical research and

education, and advocacy for issues related to these diseases. Specifically, the Foundation acts as an information clearinghouse for newly diagnosed patients and provides these individuals with an opportunity to interact with other primary immune

deficient patients and families. Oftentimes, the most reassuring call a parent of a

newly-diagnosed child will make is not to a doctor or hospital, but to one of our local

patient representatives with his or her own children playing loudly in the backyard.

This opportunity to speak directly and frankly to another parent in a similar situation often is the first chance to seek support and results in a level of comfort that

with proper treatment their child can grow up with a near-normal life.

The foundation is also active in medical research to try to better define and diagnose these diseases. While we search for these longer-term answers, we are also

looking to improve current treatment options for patients as well as improve understanding of these diseases within the medical community. Because primary immune

deficiency is a rare disease, we focus on providing educational opportunities such

as visiting professorships and grand rounds for physicians and medical students

who might otherwise not be exposed to this knowledge. The foundation is also working through an NIH grant that I will discuss in more detail later to help better identify the range and occurrence of these diseases.

Finally, IDF has a very active public policy program that focus on blood safety

issues, patient reimbursement for treatment, and advancing scientific knowledge regarding primary immune deficiency diseases.

Mr. Chairman, I am both a patient, a physician, and the newly elected Chairman

of the IDF Board of Trustees. My case is representative of a typical immune deficient patient. I was diagnosed with Common Variable Immunodeficiency 10 years

ago, following years of repeated infections, which were unresponsive to antibiotics,

and undiagnosed by numerous physicians who happened to be colleagues of mine.

This led to numerous unsuccessful surgeries resulting in permanent lung and sinus

damage. Prior to my diagnosis, a day was considered successful if I had enough energy to get out of bed. Following appropriate diagnosis and treatment with IGIV,

I was able to return to my medical practice and developed a new lease on life.

In my testimony, I would like to highlight three areas of importance to the IDF

and the primary immune deficiency community we represent: (1) National Primary

Immune Deficiency Surveillance Program. (2) Primary Immune Deficiency Research

at the National Institutes of Health. (3) Primary Immune Deficiency Registries at

the National Institute of Allergy and Infectious Diseases.

NATIONAL PRIMARY IMMUNE DEFICIENCY SURVEILLANCE PROGRAM

Mr. Chairman, because primary immune deficient patients are the only patient

population that require life-long infusions of IGIV to maintain their health, the Immune Deficiency Foundation has been working to establish a national surveillance

study of this group to evaluate the short and long term effects of IGIV use. The establishment of this surveillance initiative is vitally important because although primary immune patients have been treated with IGIV for over 20 years, a prospective

study on adverse events associated with its use has not been performed.

IDF’s surveillance program would provide valuable epidemiological data on the

potential risks of IGIV therapy, and conditions which might predispose patients to

adverse events. In addition, this initiative would benefit other IGIV users by serving

as an early warning system should study participants be exposed to new and emerging pathogens.

IDF’s proposed surveillance study would focus on the following:
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—Identifying and characterizing adverse events

—Determining their prevalence and incidence

—Determining whether there are specific risk factors for adverse events such as:

(1) Certain primary immunodeficient diseases (e.g., Common Variable Immunodeficiency vs. X-Linked Agammaglobulinemia); (2) Pre-existing medical conditions (e.g., renal and/or cardiac disease); and (3) More common with some preparations than with others (e.g., different brands and different formulations).

Mr. Chairman, IDF has been working with the plasma fractionation industry, the

Food and Drug Administration, and the Centers for Disease Control and Prevention

to establish this new surveillance program, and we are grateful for the subcommittee’s support of this partnership last year as we developed the details of this project.

Now that the program is nearing the end of the planning stage, we ask that you

continue to support this important public health initiative by encouraging CDC to

work with us again in fiscal year 2002. Moreover, we ask that you encourage the

National Institutes of Health to support this effort as well.

PRIMARY IMMUNE DEFICIENCY RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH

Mr. Chairman, I would like to take this opportunity to thank the subcommittee

for its longstanding support of biomedical research at the National Institutes of

Health. IDF remains committed to the goal of the doubling the NIH budget by fiscal

year 2003. Specifically, IDF encourages the subcommittee to continue its support of

primary immune deficiency research at the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), and the National Cancer Institute (NCI).

In recent years, NIAID sponsored research has shed new light on the genetics of

primary immunodeficiencies. NIAID investigators are using this information to develop new gene-based therapies for many primary immune disorders. This cuttingedge research has given patients hope that improved therapies, and eventually a

cure, for these diseases may be on the horizon. Primary immune deficiency research

also benefits people suffering from other disorders, such as autoimmune diseases

and cancer, due to its acute focus on the functions of the immune system.

Recognizing the promise that biomedical research holds for improving the quality

of life for primary immune deficient patients, IDF joins with the Ad Hoc Group for

Medical Research in recommending a 16.5 percent increase for NIAID, NICHD and

NCI in fiscal year 2002.

PRIMARY IMMUNE DEFICIENCY CLINICAL REGISTRIES PROGRAM

Mr. Chairman, since 1997, IDF has contracted with NIAID to construct and maintain registries of 8 primary immunodeficiency diseases including, Chronic

Granulomatous Disease, Common Variable Immunodeficiency, DiGeorge Anomaly,

Hyper IgM Syndrome, Leukocyte Adhesion Defect, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, and X-Linked Agammaglobulinemia. The goal

of these registries is to assemble a comprehensive clinical picture of each disorder,

including estimates of disease prevalence, clinical course, and complications.

This data is an invaluable resource for physicians conducting basic research on

these disorders. For example, information from one registry (chronic granulamatous)

is being used by four institutions to examine six different questions relating to various aspects of the disease. Further expansion of these registries is essential if we

are to increase our understanding of additional primary immune deficiency disorders. IDF appreciates the subcommittee’s longstanding support of the NIAID/IDF

clinical registries partnership and encourages you to continue to support these important programs in fiscal year 2002.

Mr. Chairman, thank you once again for the opportunity to present the views of

the Immune Deficiency Foundation.

PREPARED STATEMENT OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA’S (IDSA)

IDSA appreciates the opportunity to provide testimony to the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education concerning fiscal year 2002 funding for the Centers for Disease Control and Prevention

(CDC), the National Institutes of Health (NIH)—particularly the National Institute

of Allergy and Infectious Diseases (NIAID), the Office of AIDS Research (OAR) and

the Fogarty International Center (FIC)—and for the Health Resources Services Administration (HRSA).

IDSA represents more than 6,000 physicians and scientists devoted to patient

care, education, research, and community health planning in infectious diseases.
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Our members share a common focus on the epidemiology, diagnosis, prevention, investigation and treatment of infectious diseases. The discipline of infectious diseases

is a subspecialty of both internal medicine and pediatrics, typically involving a twoto-three year fellowship and then board certification. Infectious diseases physicians

care for patients with serious infections, including persons with HIV/AIDS, meningitis, heart valve infections, severe bone, joint or wound infections, and those with

cancer or transplants who have life-threatening infections caused by unusual organisms. IDSA is the principal organization representing infectious diseases physicians.

Infectious diseases are the second leading cause of death and the leading cause

of disability-adjusted life years worldwide (one disability-adjusted life year is one

lost year of healthy life) and the third leading cause of death in the United States.

The World Health Organization estimates that 1,500 people die each hour from an

infectious disease. Diseases, such as AIDS, hepatitis, tuberculosis, malaria and

pneumonia, as well as new and emerging infectious diseases, continue to cause

unfathomable human suffering in this country and around the world. The real and

potential implications on human lives and the escalating costs of health care in this

country is staggering. CDC reports that should an influenza pandemic occur in the

United States today with the ferocity of past ones, it would cause an estimated

89,000 to 207,000 deaths, 314,000–734,000 hospitalizations; and the economic impact would range from $71 billion to $167 billion.

Earlier predictions of the elimination of infectious diseases did not take into account changes in demographics and human behaviors and the extraordinary ability

of microbes to adapt, evolve, and develop resistance to drugs. More than 35 newly

emerging infectious diseases were identified between 1973 and 1999, and new infectious disease threats continue to be identified. The continual evolution of emerging

and reemerging diseases, particularly the acceleration of the HIV/AIDS pandemic in

developing countries, will heighten the global impact of infectious diseases in this

century.

But the story is not all bleak. Advances made over the past century in infectious

diseases treatment, prevention and research, particularly related to vaccines’ development, and infection control have demonstrated the many benefits that biomedical

research and public health may have in bringing these diseases under control. As

the physicians who care for patients with serious and often life-threatening infections and as researchers who study drug resistance and are involved in development

of new and better antimicrobial agents, our goal is to ensure that patients have access to state-of-the-art care and that the care provided is the most clinically appropriate for each patient.

We strongly believe that today’s investment in infectious diseases prevention,

treatment, and research will pay significant dividends in the future to the American

people in dramatically reduced health care costs and improved quality of life for millions. As such, the Society has strongly advocated for appropriate funding for biomedical research, public health and infrastructure building. And, as infectious diseases do not recognize nor respect arbitrarily determined national borders, IDSA

also adamantly supports United States’ leadership in funding international collaborative efforts to fight transmission of infectious diseases through international research and infrastructure building in lesser-resourced countries.

NATIONAL INSTITUTES OF HEALTH

It is unlikely that we can overestimate the importance that the National Institutes of Health have had in advancing the continuum of disease knowledge now

available. NIH is largely responsible for orchestrating current efforts in scientific

discovery and for training future scientific leaders. The National Institutes of Allergy and Infectious Diseases (NIAID), NIH’s Office of AIDS Research (OAR) and

the John E. Fogarty International Center (FIC) are largely responsible for fulfilling

those goals in the field of infectious diseases in the United States and around the

world. NIAID-, OAR- and FIC-sponsored research and training in the areas of HIV/

AIDS, sexually transmitted diseases, tuberculosis, malaria, new and emerging infectious diseases, antimicrobial resistance and genomics will significantly and favorable

impact the health of millions of Americans and people of all countries.

We applaud Congress’ and the Administration’s commitment to increase support

for NIH’s programs and to double its budget by 2005. We can think of no more important investment than for the basic and clinical research that NIAID, OAR and

FIC sponsors and conducts. We would note that, although the FIC’s budget has increased substantially over the past several years reaching $50 million in fiscal year

2001, this amount is a small fraction of what is necessary to carry out the increasingly important international research and training that FIC supports around the
569

world. Thus, we recommend that you closely review FIC’s budget with an eye toward providing a significant increase in funding for the Center in fiscal year 2002.

CENTERS FOR DISEASE CONTROL AND PREVENTION

CDC is the nation’s prevention agency. Its important mission is to translate

health information, including the results of NIH-sponsored research, into prevention

programs that are effective in the diversity of our nation’s communities. They do

their work in partnership with state and local public health providers and other

Federal agencies. CDC programs make public health work around the nation.

Increased surveillance and response, applied research, infrastructure building and

training and prevention and control efforts are all necessary if we are to meet the

challenges that infectious diseases will create in the years to come. CDC’s Strategic

Plan Preventing Emerging Infectious Diseases: A Strategy for the 21st Century continues to build domestic and global capacity for recognizing and responding to infectious diseases. Providing health departments with resources for building epidemiology and laboratory capacity has dramatically improved our ability to identify, investigate, and rapidly implement control measures in outbreak situations (such as

with West Nile in the eastern United States and E.Coli, Salmonella and Listeria

in other parts of the country).

Both NIH and CDC’s work are inextricably linked. And, while we strongly support

the Administration’s proposed funding for NIH, we maintain that Congress’ and the

Administration’s commitment to CDC must not waiver. Increased funding for NIH

must not be appropriated at the expense of CDC and/or other public health programs. Thus, we support increased funding to enable CDC to implement the activities envisioned in its Strategic Plan. It is our best professional judgment, given the

many unmet public health needs and missed prevention opportunities, that CDC

funding should be increased to $5 billion, a $1.2 billion increase over fiscal year

2001 levels, to permit the agency to adequately fulfill its mission.

Moreover, the ever-evolving complexity of CDC’s budget structure and the increased practice by Congress to dedicate particular funds for specific projects is a

cause of great concern to the public health community and fiscal planners. A

Pricewaterhouse/Coopers study has determined that CDC’s budget structure is particularly inflexible and that this may have negative implications for public health.

The General Accounting Office has concurred with these findings. We ask that Congress review this analysis and act accordingly to afford CDC the flexibility to effectively and efficiently carry out its public health mission.

HEALTH RESOURCES AND SERVICES ADMINISTRATION

Programs administered through the Health Resources and Services Administration serve as vital components of the nation’s health care safety net. From funding

for health professionals’ training to resources for community health centers and

HIV/AIDS services, HRSA funding provides vital resources that translate into

health care for underserved and disenfranchised populations. Of particular interest

to IDSA is funding for the Ryan White CARE Act, a program that funds medical

care, drug therapy for HIV disease and HIV-related opportunistic infections, and ancillary services for uninsured and underinsured individuals, as well as training for

health care providers. IDSA urges the Subcommittee to support generous funding

for all Titles of the Ryan White Care Act so that biomedical and clinical research

may benefit all Americans living with HIV disease.

SIGNIFICANT FUNDING NEEDS EXIST

Now, we would like to highlight a few specific public health and research areas

where increased funding is needed.

Antimicrobial resistance

In the United States and around the world, many important human infections are

becoming increasingly resistant to the antimicrobial drugs used to treat them. For

example, CDC reports that in some areas of the United States, more than 30 percent of infections with pneumococci, the most common cause of bacterial pneumonia

and meningitis, are no longer susceptible to penicillin. In the 1970s, all were susceptible. Moreover, nearly 30 percent of the bacteria that most frequently cause infections acquired in hospital intensive care units are resistant to the preferred antibiotic.

We must respond to the persistent problem of antimicrobial resistance by increasing research efforts, creating surveillance systems and developing strategies to ensure that newly developed and existing drugs are used effectively. An interagency

task force, co-chaired by CDC, the Food and Drug Administration and NIH recently
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released ‘‘A Public Health Action Plan to Combat Antimicrobial Resistance’’. The

Plan outlines a number of surveillance, prevention and control, research, and product development action items. Increased funding is necessary to permit these agencies to move quickly to implement these critical action items. We also support full

funding to implement the Public Health Improvement Act that was enacted last

year.

Food safety

According to CDC, food-borne diseases cause approximately 76 million illnesses,

325,000 hospitalizations, and 5,000 deaths in the United States each year. Hospital

costs for these illnesses are estimated at more than $3 billion per year. Costs from

lost productivity are estimated at $8 billion per year.

Through the National Food Safety Initiative, Congress has supported increased

funding over the past several years, which has enabled the Department of Health

and Human Services (HHS) and U.S. Department of Agriculture (USDA) to move

aggressively to reduce the impact of food-borne illness in this country. CDC, USDA,

and FDA have developed and implemented critical, new research, surveillance, education and prevention efforts, under this initiative. We encourage Congress to continue to lead the way in this effort by increasing funding for the Food Safety Initiative.

Bioterrorism

The nation’s public health infrastructure is not adequate to detect and respond

to a bioterrorism event in this country. The potential for such an event increases

with each passing day. Timely response to a bioterrorism event will absolutely depend upon a sound monitoring system at the community level. Such a system will

require strong support for state and local public health infrastructure, particularly

adequately equipped and staffed laboratories, and support as well for a program

that cuts across all centers and programs at CDC. To this end, increased funding

is needed to implement the activities authorized last year through the Public Health

Improvement Act. Only through sufficient funding for assessments of local capacities to respond to an event, infrastructure development and training, vaccine research and development at NIH and coordinated response efforts across governments and health care organizations will we be able to anticipate problems,

prioritize resources, and intervene effectively.

Vaccines and immunization

Immunizations are among the greatest public health achievements of the 20th

Century. With the advent of vaccines for chickenpox, measles, whooping cough,

polio, pneumococcal disease, hepatitis B, influenza and other infectious diseases,

thousands of lives have been saved and disability and suffering averted with incredible cost savings achieved. Despite generally high coverage levels in the United

States, pockets of under-immunized children, adolescents and adults remain at increased risk for contracting and transmitting vaccine preventable diseases. The

global picture is much more ominous.

Additional funding is needed to shore up the nation’s immunization infrastructure. In an Institute of Medicine report released last year, entitled Calling the

Shots, experts agreed that unstable funding for state immunization programs

threatens coverage for specific populations and age groups. In addition, according

to CDC, immunization costs for more than 12 million Americans are not covered by

public or private health insurance programs. This is shocking given the level of importance to public health and the demonstrated cost-effectiveness that have been realized as a result of the establishment of the National Immunization Program (NIP).

Increased funding is critical to ensure that every individual may have access to appropriate vaccines.

Sufficient funding for CDC’s programs to eliminate measles in the Western Hemisphere and to eradicate polio worldwide also is critical. The benefits of these programs are not limited to other countries; in the United States alone, the eradication

of polio would result in a yearly cost savings of $230 million.

Finally, new vaccines’ research and development will help us to prevent populations from becoming infected in the first place. Researchers at NIAID are working

to develop vaccines for tuberculosis, HIV and Streptococcus pneumoniae, the leading

cause of morbidity and mortality in infants and young children worldwide. NIHsponsored research has proven successful in the past, most notably with the development of vaccines against Haemophilus influenzae type b (Hib) a bacterium that

can lead to life-threatening meningitis and pneumonia in young children. Thanks

to the work of NIH researchers, this vaccine reduced the number of cases of invasive

Hib disease by 97 percent from 1987 to 1997. In order to repeat this success with
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other diseases, we urge your continued support for vaccine research and development.

HIV/AIDS

A comprehensive funding strategy through NIH’s Office of AIDS Research, CDC’s

prevention programs and HRSA’s primary care services is the only appropriate response to the HIV/AIDS epidemic. Increased funding for AIDS through the Office

of AIDS Research is critical. Through the research that it supports, the Office of

AIDS Research holds the most promise for saving and improving many lives

through the development of improved treatments for people living with HIV/AIDS

and the development of an HIV/AIDS vaccine. CDC plays a key role in the fight

against the spread of HIV/AIDS. With 40,000 new cases of HIV being diagnosed

each year, this is no time for complacency. We strongly encourage increased investment in CDC’s HIV/AIDS programs. These include the HIV/AIDS surveillance program that tracks the disease and informs the development of national and local prevention efforts; funding of community-based programs that design and implement

prevention programs targeted at their communities; and the variety of programs

funded through the Congressional Black Caucus (CBC). The CBC programs deserve

special attention given the alarming increase of HIV/AIDS in minority communities.

To adequately support these and other important programs, CDC funding for HIV/

AIDS programs should be increased substantially. The Ryan White CARE Act administered under HRSA is the heart of the federal response to HIV/AIDS care. Generous funding for all titles of the CARE Act are necessary to maintain the significant reductions in HIV-related morbidity and mortality we have enjoyed in recent

years.

Finally, IDSA strongly supports HHS’ global AIDS efforts. Substantial increases

are warranted for new research, treatment and prevention strategies, and public

health infrastructure building in lesser-resourced countries. Our Society supports a

robust and comprehensive U.S. response to the global HIV/AIDS pandemic. We will

be advocating for increased funding in other federal budget accounts as well.

Thank you again for the opportunity to provide IDSA’s views on these important

matters to the subcommittee. Please let us know if you require any additional information.

PREPARED STATEMENT OF THE JOSLIN DIABETES CENTER

Mr. Chairman and Members of the Subcommittee, I appreciate the opportunity

to appear before you to present Joslin Diabetes Center’s proposal to improve the access to and quality of health care for people with obesity and type 2 diabetes and

to reduce costs and increase savings for these health care outlays by establishing

a new paradigm for the prevention and treatment of obesity and type 2 diabetes.

Obesity is a major risk factor for the development of type 2 diabetes and insulin

resistance and a major cause of morbidity and mortality in the Unites States:

—1 in every 2 Americans is overweight and the prevalence of obesity has increased 57 percent in the last 10 years.

—Obesity disproportionately affects minorities—60 percent of African-American,

Mexican-American, and Native-American women meet the criteria for being

overweight and between 33–37 percent are obese.

—Obesity in children and adolescents is increasing at an alarming rate, leading

to the occurrence of type 2 diabetes in these groups.

Equally foreboding for the future well-being of our country, the startling rise in

obesity is driving an emerging epidemic of diabetes in the United States:

—Diabetes in the United States increased by 6 percent in 1999.

—Over 90 percent of diabetes is type 2 (adult-onset), and 90 percent of people

with type 2 are obese.

—The Centers for Disease Control and Prevention reported that diabetes increased 33 percent nationally to 6.5 percent between 1990 and 1998.

—The rise in diabetes costs increased across all age groups but was most profound—about 70 percent—among people ages 30–39.

— For the rapidly expanding over-50 age group, the incidence of diabetes approaches 20 percent, and diabetes and its complications comprise 25 percent of

Medicare costs.

Obesity is a risk factor for:

—Diabetes

—Cardiovascular disease—heart attack, stroke

—High blood pressure

—Sleep apnea
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—Uterine cancer

—Breast cancer

—Colon cancer

—Gall bladder disease

With over 50 percent of the population obese, these risk factors underscore why

this serious problem is emerging as an epidemic.

As the world’s largest and most comprehensive independent diabetes research and

patient care institution, Joslin Diabetes Center proposes the development of a pilot

program to prevent and treat obesity and type 2 diabetes. Over 80 percent of people

with type 2 diabetes would be ‘‘cured’’ if they could lose 10–20 pounds of weight.

Unfortunately, 90 percent of these people with type 2 diabetes cannot successfully

lose weight because obesity is a medical problem and not a moral fault.

To address the growing epidemic of obesity and type 2 diabetes, Joslin Diabetes

Center would like to share technology, methods and experience through the development of a pilot demonstration project for the prevention and treatment of obesity

and type 2 diabetes:

—To adapt Joslin’s state-of-the-art Diabetes Outpatient Intensive Treatment Program for different ethnic, economic, social and age population groups.

—To demonstrate the effective long-term benefits of Joslin’s Intensive Treatment

and telemedicine protocols.

—To evaluate clinical strategies for prevention and treatment of obesity including

the application of our growing knowledge of molecular mechanisms that increase appetite and of the role of leptin in obesity.

—To analyze different diets of people with type 2 diabetes.

—To advance Joslin’s applied research results in the development of preferences

for alternative food choices and lifestyles and community-level and school interventions to prevent obesity and the onset of diabetes.

Joslin’s pilot project would demonstrate significantly improved prevention and

treatment of obesity and type 2 diabetes, resulting in reduced costs, improved patient access and quality of life.

Specifically, we propose to initiate a pilot project of detection, prevention, and care

of obesity and type 2 diabetes for a three-year period, utilizing training and validation exercises derived from Joslin’s expertise and telemedicine infrastructure. The

cost would be $3.6 million annually.

Through its Diabetes Outpatient Intensive Treatment Program, Joslin applies a

new approach towards patients with diabetes. This approach focuses on two major

areas: improving clinical outcomes in a practical, resource-efficient manner. Clinical

outcomes have demonstrated improved metabolic control (and thus fewer long-term

complications) and reduced patient stress resulting from having to treat their diabetes. The Program is focused on individual flexibility and was developed in a way

to be more efficient in utilization of both patient resources and health-care resources.

Rather than rely on continued intensive involvement of health care providers

throughout a patient’s lifetime, we put the patient through a short, intensive course

of training which not only leads to an immediate improvement in their metabolic

control, but gives the patient the foundation to take care of themselves in the future. The Program also reduces the patient’s diabetes-related stress by training the

patients to care for their own diabetes, seeking other professional input when needed. This is more appealing to the patient, more efficient in the use of resources in

the long-term, and produces good results.

With the proposed pilot project, Joslin is in the process of developing an alternative Outpatient Intensive Treatment Program for people with obesity and type 2

diabetes. The pilot project will establish and validate appropriate criteria, protocols

and outcome guidelines for different ethnic, economic, social and age population

groups.

Utilizing Joslin’s JVN telemedicine infrastructure, Joslin Diabetes Center will design and develop a modularized medical outcomes-based Telemedicine Diabetes Intensive Treatment Program to provide a web-based Comprehensive Diabetes Management System. Integrating Joslin’s JVN telemedicine infrastructure as a component of the CDC can link health care practitioners with the National Diabetes Education Program, targeting the segment of the population that suffers from the epidemic explosion of obesity and diabetes complications. Adaptation of Joslin’s JVN

system for treating obesity and type 2 diabetes can measurably improve patient access, compliance, education and motivation to further increase effective long-term

individual and society health benefits.

Ongoing research at Joslin addresses how complex molecular mechanisms regulate body weight (hormones that control eating and appetite), how the fat cell functions as an endocrine cell, how leptin signaling the brain affects eating, and how
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fat interacts with the beta cell to cause diabetes. Resulting new clinical strategies

for prevention and treatment of obesity and diabetes complications will be incorporated as a component of the pilot project.

The three-year demonstration pilot will additionally provide the opportunity to

broaden the clinical applications of promising bariatric surgery and medical therapy

protocols for alleviating obesity and resulting diabetes complications. Evaluation of

strategies for the prevention and treatment of obesity and type 2 diabetes will analyze long-term effects of gastric by-pass (bariatric) surgery, including clinical evaluation of people with gastric bypass surgery and the clinical evaluation of medical

therapies to further refine Joslin’s new paradigm of intensive treatment of obesity

and type 2 diabetes.

The demonstration project will train health care providers, e.g. nurse educators

and physicians, from and for different ethnic, economic, social and age population

groups. Concurrently, Joslin will provide curriculum-based patient and provider

education modules.

The proposed pilot project will demonstrate significantly improved detection, prevention and care techniques for obesity and type 2 diabetes, resulting in overall reduced costs, improved patient access, and improved quality of life. Furthermore, this

demonstration of Joslin’s new paradigm for obesity and type 2 diabetes health care

will provide better clinical understanding and expertise, which can be effectively extended to benefit all people living with type 2 diabetes.

Thank you for this opportunity to appear before you today. I would be pleased to

answer any questions you might have.

PREPARED STATEMENT OF THE JUVENILE DIABETES RESEARCH FOUNDATION

INTERNATIONAL

Brayton James DiPietro

Before I begin, I would like to thank the Senate Appropriations Subcommittee on

Labor, Health and Human Services, Education and Related Agencies for giving me

the opportunity to share my story. My name is Brayton DiPietro and I am pleased

to testify on behalf of the Juvenile Diabetes Research Foundation. I am in the

eighth grade at St. Paul’s Grade School in North Canton, Ohio. I also have diabetes

and was diagnosed just after my eleventh birthday. I will be fifteen this June, so

this summer will mark four years that I have had the disease.

I broke my leg on December 15 while sledding in my backyard. The doctors were

unable to use any rods or pins in setting my break because people with diabetes

run a high risk of infection. We also heal slower. For a person with diabetes, the

entire process would have taken about one fourth as long.

Many people believe that the life of an individual with diabetes doesn’t change

dramatically once diagnosed. I am here to tell you that that is not true. Three or

four times a day, I have to check my blood sugar by pricking my finger and give

myself an injection of insulin. I have to think about every single thing that I eat

and when I eat it. As a teenager, it won’t surprise you that I would love to sleep

in on a Saturday morning. However, if I do that it would throw of my blood sugar

levels and it could take several days to get back on course.

Those, of course, are the good days. When I have the flu, I have to check my blood

sugar constantly and my urine for ketones to make sure that I don’t go into

Ketoacidosis, a condition that could be fatal in less than 24 hours. When I play

baseball, I have to check my blood sugar level every other inning to make sure I

am maintaining proper blood sugar levels. Even taking these precautions, I have experienced loss of vision, dizziness, and general disorientation during a game.

I don’t really know what I am going to be yet when I grow up. I know that I can’t

be a pilot for the Navy because of my diabetes. Can you imagine what would happen

if I blacked out in a combat situation?

I have approximately 6,000 finger pricks plus an equal amount of insulin injections in the past four years. That doesn’t even count regular drawing of blood tests

at the doctor’s office. While I wait for a cure, which I know will happen if you continue to generously support medical research at the National Health Institute and

help ensure that juvenile diabetes research is adequately funded, the best thing that

I can do is to continue to take proper care of myself, remain disciplined, and try

to lead as normal a life as possible.

Back in Canton, I heard a lot about the not so good things that happen in Washington these days. I am really glad to have the opportunity to be part of a good

thing that is happening in Washington. Your subcommittee’s leadership in doubling

the NIH budget by 2003 could allow me to live a fuller and healthier life. Thank

you.
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Steven DiPietro

Brayton’s story is not unique. In one form or another, it is shared by each of the

16 million Americans who have diabetes. In addition to its personal burden, diabetes carries an extraordinary price tag—one in four Medicare dollars are attributable

to individuals with diabetes, and the disease costs our nation more than $100 billion

annually. If we could cure diabetes it could both solve the Medicare solvency problem and be a major boost to our economy!

As you may imagine, I am very proud of my son, who I witness each day persevere through his daunting, daily regimen of living with diabetes. I do my share

in fighting juvenile diabetes by volunteering with my local chapter of the Juvenile

Diabetes Research Foundation, where I currently serve as Board President. I am

pleased that through our local walks, galas, and special events, JDRF will be able

this year to allocate $120 million for juvenile diabetes research.

However, we can’t do it alone. This is why your continued support for the bipartisan effort to double the NIH budget over five years and provide the NIH with a

$3.4 billion increase in funding this year is critical to individuals with diabetes.

Last year, researchers announced that seven individuals with diabetes had been

‘‘cured’’ of the disease following the successful transplantation of insulin-producing

cells. In my mind, the question is no longer whether we will cure diabetes, but when

will it happen. Your support for doubling the NIH budget will make this happen

sooner, and my family, and the millions of others who have diabetes want to thank

you for making their hopes and dreams possible.

PREPARED STATEMENT OF THE KENNEDY KRIEGER INSTITUTE

Mr. Chairman, Members of the Committee, the Kennedy Krieger Institute in Baltimore, Maryland appreciates the opportunity to present its views on a number of

important programs supported by the U.S. Department of Education; the National

Institutes of Health and the Health Resources and Services Administration at the

U.S. Department of Health and Human Services.

We would like to highlight the efforts of three federal agencies under your jurisdiction and the important work that they do to strengthen the capacity of programs,

such as the Kennedy Krieger Institute, to make progress in the important areas of

education and health.

THE KENNEDY KRIEGER INSTITUTE

The Kennedy Krieger Institute is an independent research institution located adjacent to Johns Hopkins University. The mission of the Institute is to focus solely

on disorders related to the brain and central nervous system. Brain related disorders effect one in four adults and one in ten children at a cost to society of $400

billion per year. The overall goal of research at the Kennedy Krieger Institute is

to understand the developing central nervous system through the study of relationships between genes, the brain and human behavior. Although the Institute has

special expertise with regard to children, the research scope includes studies of

changes in the brain and the central nervous system across the lifespan. The Kennedy Krieger Institute is a comprehensive resource for children with disabilities,

recognized as a research facility and training center for health care professionals

from around the world. The Institute treats a wide array of children with neurological diseases including, but not limited to, Down syndrome; attention deficit hyperactivity disorder; lead poisoning, autism; cerebral palsy; genetic and metabolic

disorders, like fragile X syndrome, neurofibromatosis, tay sachs disease, tourette

syndrome; spina bifida; degenerative brain disorders; mental retardation; and many

others. Our Institute integrates cutting edge neurobiological and behavioral research efforts into a comprehensive program which includes inpatient and day treatment services; outpatient services; home and community services; and school programs for children with disorders of the brain. The Institute is well-known for its

strong interdisciplinary research and care in many fields including medicine, psychology, education, physical and occupational therapy, audiology, speech and language therapy, social work, child development, nutrition and nursing.

BASIC AND CLINICAL RESEARCH

The Board of Directors, the researchers, health professionals and patients and

families at the Kennedy Krieger Institute are all very grateful for the support that

this Committee has provided to the NIH over the past several years. The resources

that Congress has appropriated have enabled the research community to grasp re-
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search opportunities that a decade ago we could not even have dreamed possible.

This is making an incredible difference in the lives of the children that we treat.

We are currently experiencing an unprecedented appreciation of the benefits to

health and life quality that can result from biomedical and behavioral research. Of

particular note is the most welcome present and predicted increase in public sector

funding for basic research and the dramatic, if not explosive, private sector investment in biology. With such appreciation and tangible support comes the responsibility to organize the scientific enterprise so as to produce effective interventions.

And, our challenges are many.

Many children with developmental disabilities and neurological diseases display

severe behavior problems. The mission of our basic and clinical research, clinical

care, and educational programs is to improve the quality of life for these children

and their families through a variety of mechanisms including:

—providing advanced and comprehensive treatment services;

—promoting the widespread dissemination of effective interventions; and

—improving treatment technologies through basic and clinical research.

With that said, we support treatment and research initiatives including but not

limited to behavior programs, pediatric feeding disorders, neuroimaging, basic and

clinical research efforts and training.

The National Institute of Child Health and Human Development (NICHD) and

the National Institute of Neurological Diseases and Stroke support a number of important initiatives with regard to brain biology; neurobehavioral assessment and

protocol development; translation studies related to cognition pathways of learning

disorders from a developmental perspective; molecular sciences to further understand the molecular basis of many developmental disabilities; brain mapping; and

other basic and clinical programs which are at the core of the programs conducted

at the Kennedy Krieger Institute. Further, the National Center for Research Resources (NCRR) supports important neuroimaging studies for neuroscience, metabolic, behavioral, and other research. The Kennedy Krieger Institute receives funding from the NCRR for our neurobehavior research unit through a subcontract from

the Johns Hopkins University General Clinical Research Center (GCRC). The support we receive is used to conduct studies related to functional imaging. We believe

it is important for the Committee to consider an NIH National Imaging Network

for Clinical Research that will enable NCRR to provide the resources to create links

between the GCRC to the imaging center. This sort of infrastructure would be vitally important to facilitate and integrate research networks.

Clearly, multiple programs supported by the National Institutes of Health (NIH)

enrich our capacity to address important basic and clinical research issues in the

population that we serve. The work of this Committee ensuring a sustained commitment to these programs has enabled institutions, such as ours, to move forward at

unprecedented speed. To that end, we urge the Committee to continue its efforts in

support of the NIH.

Request.—The Kennedy Krieger Institute endorses the recommendation of the Ad

Hoc Group for Medical Research Funding for fiscal year 2002 which recommends a

$3.4 billion, or 16.5 percent, increase that will result in a total NIH budget of $23.7

billion in fiscal year 2002. This funding level is necessary to continue the congressional campaign to double the budget of the NIH by 2003.

EDUCATION

Our approach to severe behavioral problems in many children with developmental

disabilities and severe behavior problems is multi-focused. The Severe Behavior Program provides comprehensive diagnostic evaluations, parent training and school

consultative services. The linkage to the child’s school and school district is imperative to develop and effectively implement effective strategies to deal with the behavioral problems many of our patients present with. This initiative is complemented

by inpatient and outpatient behavioral management services for children who display severe destruction behavior.

The Kennedy Krieger Institute’s Lower and Middle Schools, recipients of the US

Department of Education’s National Blue Ribbon Awards in 1996 and 1997, respectively, are recognized models in special education. Their track record includes: innovative models of education based upon current scientific understanding of brain

functioning; creative integration of technology in the classroom; comprehensive curriculum tailored to unique needs of the student; and training in the field of special

education.

Employment data for all youth in the United States are a national concern. Fewer

students are graduating from high school adequately prepared to enter post-secondary program or secure competitive employment. Of particular concern are youth
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with disabilities, who are consistently less successful than their non-disabled peers.

It has been estimated that 70 percent of individuals with disabilities are either unemployed or underemployed.

The Kennedy Krieger high school program, which opened in September, 1999, provides a comprehensive approach to school-to-work transition for youth with serious

learning, emotional, neurological, and developmental disabilities. The school-to-work

curriculum at our Career and Technology High School is unique in that it will be

the only program in the state to make career training the foundation of, and not

merely a supplement to, the school’s core curriculum. All of the students that attend

the Kennedy Krieger Career and Technology High School demonstrate a serious disability, and 50 percent of these students come from families supported by federallyfunded programs for children and families living below the poverty level. As the

school’s student population grows from the current enrollment of 125 to 200 students, it is anticipated that the percentage of students living below poverty will remain current if not increase.

Drawing on the most current educational, work-readiness, and industry standards, the high school staff develop partnerships with business and community

groups to develop a state-of-the-art model that will result in economically and personally rewarding employment for youth with disabilities. The Career and Technology High School will take students challenged by severe learning, emotional,

traumatic brain injury, and developmental disabilities and provide a school-to-work

instructional model that addresses the needs of students with serious disabilities

who have the potential to undertake meaningful employment. Students will graduate with the knowledge and work and social experience they will need for successful postsecondary employment in a specific career clusters including: Information

Technologies; Hospitality; Tourism Construction and Manufacturing; Business and

Finance; Arts and Graphics; and Communications. Programs supported by the Department of Education, including the Technology Innovation Challenge Grant program are critical to enable cutting edge programs such as our to fully develop our

capacity to create model systems which can be applied nationwide. The strong support that this Committee has provided to these programs in the past have been a

worthwhile investment and we urge your continued strong support.

Request.—The Kennedy Krieger Institute respectfully requests $2 million in program funding from the Department of Education’s Technology Innovation Challenge

Grant program to support the expansion of a dynamic performance-based curricula

and instructional delivery options utilizing distance learning that connects educational and research programs. Students, teachers, parents, and other professionals

will receive support through instructional software, performance databases, access

to the Internet, and opportunities for self-directed learning.

MARCUS INSTITUTE, ATLANTA GEORGIA

The Kennedy Krieger Institute has embarked upon a collaboration and formal fiscal affiliation with the Marcus Institute, located in Atlanta, Georgia, to establish a

national network of developmental services for children with disorders of the brain

and their families. The foremost goal of this national initiative is to rally support

and spearhead unified advocacy for individuals with developmental disabilities and

severe and challenging behaviors so that they can experience a greater quality of

life and participate as fully as possible in family, school, and community life.

Currently, the Marcus Institute is housed in leased space within a professional

office park—a location woefully inadequate for the programs and specialized services

provided to the severely disabled children served by the Institute. We are in the

process of developing an 80,000 square foot facility near the Emory University campus and the Centers for Disease Control and Prevention. The new facility will allow

the Institute to expand upon its mission to encourage and facilitate advanced research, training, and programming for children and adolescents with developmental

disabilities and severe and challenging behaviors through the further refinement

and expansion of the Marcus Behavior Center. This behavior center of excellence is

devoted to providing the most advanced clinical treatments, training, and research

so that services for the families of children with severe and challenging behavior

are as effective and as comprehensive as possible.

The new Marcus Institute will include a school with a student population of approximately 50 children. The school will work with those children with the most

acute emotional, behavioral, and psychological challenges to continue their educational process while receiving our specialized services and avoid additional difficulties when they return to their community school. The Marcus Institute school

is designed continue their education while they are here, rather than permanently

removing them from their community school.
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Since 1993, the Marcus Institute has provided clinical services to more than

14,000 individuals, conducted research, and provided education and training programs. These services have been provided by developmental pediatricians, psychiatrists, behavioral, clinical and neuro-psychologists, neurologists, geneticists, nurses,

physical, occupational, and speech therapists, social workers, special educators, and

family support personnel.

The Marcus Institute in Atlanta and Kennedy Krieger Institute (KKI) in Baltimore have developed a partnership in which programmatic, research, and training

expertise is shared to provide community-based treatments for children with developmental disabilities who display the most severe forms of behavior disorders, including aggression, self-injurious behavior, and pediatric feeding disorders. These

behaviors pose a substantial risk to the individual(s), family members, and other

care providers. Without appropriate treatment, these children are at substantial

risk for health problems (and even death) and for lifelong placement in residential

programs, which often costs $100,000 or more per year and millions of dollars over

the individual’s lifetime. The behavior programs at the KKI have been in existence

for over 20 years. All children who receive these services show clear improvement

and over 80 percent meet their primary discharge goals (compared with less than

2 percent for traditional outpatient mental health services).

The Marcus and Kennedy Krieger programs are unique not only in terms of their

success levels, but also because the effectiveness of the treatment protocols used

have been documented through systematic program evaluation data and through

formal research studies published in refereed journals. The Marcus Behavior Center

currently provides a continuum of consultative, outpatient, educational, and day

treatment services for children with severe behavior disorders. Those with the most

severe problems are seen in our intensive day treatment programs. Young children

(usually below age 6) are admitted to the Feeding Day Treatment Program if they

display behaviors such as food refusal or food selectivity (eating one or only a few

foods) that necessitate medical interventions (e.g., gastrostomy tubes) to prevent

malnutrition or death. School-aged children (ages 3 to 21) are admitted to the Severe Behavior Day Treatment Program if they have developmental disabilities and

display severe self-injurious behavior (SIB), aggression, or property destruction that

poses a significant risk to self, others, or the environment, which cannot be safely

managed or effectively treated in a less intensive program.

Less severe cases are served through our outpatient and consultative programs,

whereas the most severe cases are served through our day treatment programs. For

example, SIB consists of repetitive motor responses that produce physical harm to

the individual who displays the behavior. Typical forms of SIB include head banging, self-biting, head hitting, body hitting, scratching, eye poking, pica, and ear poking. SIB is extremely rare among individuals of normal intellectual functioning. It

is seen in approximately 6 percent to 16 percent of individuals with mental retardation and autism.

As part of our collaborative effort, the Kennedy Krieger Institute is working with

the Marcus Institute, the United States Congress, and State and local officials in

Georgia as we establish this state-of-the-art facility in Atlanta.

Request.—We respectfully request $5 million in fiscal year 2002 funding through

the Health Resources and Services Administration (HRSA) Construction account to

provide assistance with the construction of a new, state-of-the-art health facility for

the Marcus Institute. The Marcus Institute was created as a result of a generous

donation by Bernie and Billie Marcus. It is known as a nationally recognized center

for excellence for the provision of coordinated and comprehensive services for children and adolescents with developmental disabilities and severe and challenging behaviors. Our goal is to publicize any Federal grant to leverage additional dollars

throughout the private sector. Funding at the $5 million level would provide 20 percent of the total cost of the campus.

CONCLUSION

The Kennedy Krieger respectfully requests the support of the Committee through

the allocation of fiscal year 2002 funds for the following.

1. A continued commitment to the congressional campaign to double the NIH

budget by 2003 by providing a $3.4 billion, or 16.5 percent, increase for NIH in fiscal year 2002, as advocated by the Ad Hoc Group for Biomedical Research funding.

The continued investment in NIH will support a number of important research initiatives including brain biology, neurobehavioral assessment, and molecular sciences

to further understand the molecular basis of many developmental disabilities.

2. The Kennedy Krieger Institute respectfully requests $2 million in program

funding from the Department of Education’s Technology Innovation Challenge
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Grant program to support the expansion of a dynamic performance-based curricula

and instructional delivery options utilizing distance learning that connect experiences between school and the workplace. This investment will permit severely disabled students to receive support through instructional software, performance databases, access to the Internet, and opportunities for self-directed learning. 3. We respectfully request $5 million through the Health Resources and Services

Administration (HRSA) Construction account to provide assistance with the construction of a new, state-of-the-art health facility for the Marcus Institute in Atlanta

Georgia. It is known as a nationally recognized center for excellence for the provision of coordinated and comprehensive services for children and adolescents with developmental disabilities and severe and challenging behaviors.

The Kennedy Krieger Institute thanks you for the opportunity to present our

views.

PREPARED STATEMENT OF THE DRUG AND ALCOHOL SERVICE PROVIDERS

ORGANIZATION OF PENNSYLVANIA

My name is Deb Beck and I am the President of the Drug and Alcohol Service

Providers Organization of Pennsylvania (DASPOP), a statewide coalition of drug

and alcohol prevention and treatment programs, practitioners, employee assistance

programs, and drug and alcohol associations representing more than 365 organizations, programs and clinics, over 3,000 certified addiction professionals, 1,200 student assistance professionals, and 400 prevention specialists. Thank you for this opportunity to submit testimony in support of increased fiscal year 2002 funding for

alcohol and drug treatment, prevention, and research programs in the Departments

of Health and Human Services and Education.

Today I am representing the views of DASPOP, the State Associations of Addiction Services, which is composed of 27 state-based associations of treatment and prevention providers in 26 states, and the Legal Action Center, a non-profit law and

policy firm that represents individuals in recovery from and struggling with alcohol

and drug problems and AIDS.

Thank you, Mr. Chairman and members of the subcommittee, for last year’s increases for alcohol and drug treatment, prevention, and research programs and your

refusal to cut funding for these services. Funding is even more important in light

of the recent sharp increases in ecstasy use among our youth and in marijuana use

among young adults age 18 to 25. President Bush has recognized the need for expansion of these services through his campaign proposals for large increases in

funding and his encouragement of even greater participation by faith-based organizations that meet appropriate standards. We urge the Congress to dramatically expand funding for the full continuum of drug and alcohol treatment, prevention, and

effectiveness. Providing strong support for alcohol and drug treatment, prevention,

and research is essential to maintaining and improving the health and well being

of our nation. These programs save lives and money by decreasing alcohol and drug

use, crime, health care costs, AIDS and welfare dependence, and by increasing employment.

TREATMENT AND PREVENTION NEEDS IN PENNSYLVANIA

Pennsylvania programs have been leaders in developing effective alcohol and drug

treatment programs for women, youth, criminal justice offenders, and other underserved populations. However, despite the success of these programs, we are faced

with a capacity crisis that needs attention. The annual waiting list for alcohol and

drug treatment services in Pennsylvania is approximately 49,000 individuals, yet

these individuals represent only a small portion of the actual number of persons in

need of treatment services. And in spite of last year’s increases for the Substance

Abuse Prevention and Treatment (SAPT) Block Grant, this year in Pennsylvania we

are expecting that waiting list to continue to grow as pressure on public treatment

funds increases. Some factors that place a strain on these funds include:

—Reduced Medicaid Coverage.—Many individuals with alcohol and drug problems

have lost their Medicaid coverage which helped to pay for their alcohol and drug

treatment. Some individuals lost their coverage due to changes in Pennsylvania

law, while others lost Medicaid coverage because of changes in federal law

which made individuals with a primary diagnosis of alcoholism or drug dependence ineligible for SSI and Medicaid. These changes in eligibility have created

a funding shortfall of more than $80 million.

—Reduced General Support Funding.—Fewer individuals are eligible for Medicaid

coverage that pays for general health care services. When individuals without

Medicaid enter alcohol and drug treatment and require medical care, alcohol
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and drug treatment programs pay for the cost of the client’s medical care by

using general support funds that are not specifically earmarked for alcohol and

drug treatment. This reduction in general support funding results in programs

relying more heavily on funds dedicated expressly to treatment to provide alcohol and drug treatment services. These dedicated funds include the SAPT Block

Grant. —Lack of Managed Care Coverage.—Commercial managed care companies frequently deny coverage for alcohol and drug treatment, forcing individuals and

families to seek treatment in the publicly funded alcohol and drug treatment

system. —Increase in Purity of Heroin and Cocaine.—In the last few years heroin has returned to popularity due in large part to the increased purity of the substance.

This allows drug users that were fearful of injecting chemicals into their bodies

to either smoke or snort the drug. In the past, the average purity of heroin was

between 1 and 10 percent. Now authorities are noticing the percentage as high

as 98 percent in Pennsylvania compared to a national average of 35 percent.

There has also been a significant increase in the purity of cocaine, the most

commonly used drug in Pennsylvania, with an average purity as high as 80 to

90 percent. The substantial increase in the purity of these drugs has put a severe strain on the public drug treatment system, as users of these purer drugs

are more likely to quickly become addicts in need of treatment.

This increase in demand for treatment services, coupled with funding and benefit

reductions, places even more pressure on the SAPT Block Grant to provide support

for alcohol and drug treatment services. Increased fiscal year 2002 funding, especially for the SAPT Block Grant, is necessary in order for Pennsylvania to expand

access to alcohol and drug treatment services, which save both lives and money.

Pennsylvania also has developed effective community-based prevention services

that reduce the onset of alcohol and drug use among youth and other vulnerable

populations. However, decreasing Safe and Drug Free Schools State Grants program

funding will adversely impact many of these programs, requiring cuts in prevention

services for youth. Increasing funding for effective, community-based alcohol and

drug prevention programs is critical, especially in light of the recent sharp increases

in drug use among middle-school youth. The State Grants program in the Safe and

Drug Free Schools and Communities Act is a vital resource for these services.

RECOMMENDATIONS

For providers to supply these essential services in Pennsylvania and throughout

the nation, we need your support. We urge Congress to adopt the following increases

in fiscal year 2002 funding for alcohol and drug treatment, prevention, and research

programs in the Substance Abuse and Mental Health Services Administration

(SAMHSA), Department of Education, and National Institutes of Health. These are

wise investments that will provide desperately needed services in communities

across the country:

—$2.0 billion for the Substance Abuse Prevention and Treatment Block Grant to

continue closing the treatment and prevention gap.

—$350 million for the Center for Substance Abuse Treatment (CSAT) and $350

million for the Center for Substance Abuse Prevention (CSAP), including

CSAP’s High Risk Youth program, to expand Targeted Capacity Expansion programs that provide targeted, gap filling services and infrastructure tailored to

address specific and emerging drug epidemics and/or underserved populations,

and to support the continued translation of research into best practice through

Knowledge Development and Application programs.

—$694 million for the Safe and Drug Free Schools and Communities Act program,

with the increased funding ($50 million) allocated to the State Grants program

to support local, community-based prevention initiatives.

—$341 million for research at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and $991 million for research at the National Institute on Drug

Abuse (NIDA).

TREATMENT AND PREVENTION REDUCE ALCOHOL AND DRUG USE AND HAVE PUBLIC

SUPPORT

Numerous studies have demonstrated the effectiveness of treatment and prevention in reducing alcohol and drug use. As stated above, the National Treatment Improvement Evaluation Study (NTIES) evaluated CSAT’s demonstration programs

and found sustained reductions in drug use. Drug use declined by 51 percent for

crack, 55 percent for cocaine, 47 percent for heroin, and 50 percent for marijuana

for the 5,700 clients studied one year after completing treatment. NTIES also found
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a 78 percent decrease in violent crime, 19 percent increase in employment, and 11

percent decrease in welfare dependence. Prevention has also been shown to be effective in reducing use. A recent study, conducted by the University of Washington’s

Washington Kids Count project, clearly demonstrates that the level of peer substance use in middle schools has a substantial impact on the academic performance

of students across the state. The study found that on average, students whose peers

had little or no involvement with drinking or drugs scored 18 points higher in the

reading portion of the Washington Assessment of Student Learning (WASL) test

and 45 points higher on the math section.

Prevention and treatment have been repeatedly shown to be cost-effective. The Office of National Drug Control Policy estimates that drug abuse and addiction cost

this country at least $277 billion per year in deaths, medical emergencies, spread

of infectious diseases, crime, homelessness, lost productivity, and other social costs.

Expanded access to treatment and prevention would decrease this cost. A 1994 California study found that each $1 invested in drug and alcohol treatment and prevention saves taxpayers $7. These reductions in taxpayer costs were attributed to savings in criminal justice costs (22 percent), victim losses (40 percent), theft losses (69

percent), and health care costs (23 percent).

The public recognizes the value of treatment and prevention services. A 2000 survey found that 84 percent of poll respondents believed that at least half of the funding available to fight the drug problem in local communities should be spent on prevention, education, and treatment. Police have echoed the public’s support for treatment. In a 1996 survey, police chiefs from around the country ranked drug abuse

as the most serious problem in their communities and identified the shortage of

treatment programs as the most serious limitation in their ability to address drug

problems successfully.

CLOSING THE TREATMENT GAP IN OUR COMMUNITIES

Access to alcohol and drug treatment does not meet the current need for services.

While between 13 million and 16 million people need treatment for alcohol and drug

problems in any given year, only 3 million, or 20 percent receive treatment.

The need for treatment will only become greater in the future. A 1999 analysis

of data from the National Household Survey on Drug Abuse (NHSDA) projected that

the need for future treatment is expected to increase 57 percent because of increased marijuana first use and problems among the aging cohort of drug abusers

who first started using illicit drugs during the 1970s.

INCREASED INVESTMENT IN PREVENTION PROGRAMS REQUIRED

To reduce the trend of increased alcohol and drug use by youth, especially middleschool aged youth, Congress must increase its investment in community-based prevention programs. A 1998 study found that drug use jumps 300 percent in the first

year after elementary school. Furthermore, according to data from the Monitoring

the Future Study, ecstasy use has significantly increased in 2000 among all students, with a 45 percent increase in use among 8th graders.

To effectively address this important problem, every adolescent should have access

to alcohol and drug prevention services, but this is not the case nationwide. Providing universal access to effective community and school-based prevention services

requires increased funding.

DRUG AND ALCOHOL TREATMENT, PREVENTION, AND RESEARCH FUNDING MUST BE

EXPANDED

Substance Abuse Prevention and Treatment Block Grant—SAMHSA/CSAT

The majority of SAMHSA’s funding for drug and alcohol treatment and prevention

is sent directly to states through the Substance Abuse Block Grant. The Block

Grant is the primary source of federal funding for alcohol and drug treatment and

prevention services, accounting for over 40 percent of public funding for these services nationwide.

To help meet the pressing need for treatment and prevention services, we urge

Congress to fund the Block Grant at $2.0 billion for an overall increase of $335 million of fiscal year 2002 funding.

SAMHSA/CSAT & CSAP—Balancing the Knowledge Development Application Program with the Need to Target Services to Underserved Populations and Emerging Drug Epidemics

Funding at the Centers for Substance Abuse Treatment and Prevention should be

directed toward two major activities: services capacity expansion for populations at

high risk or which have increased need for treatment and prevention services and
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Knowledge Development and Application (KDA). Targeting service funding allows

CSAT and CSAP to meet the evolving needs of communities by providing targeted,

gap filling services and infrastructure tailored to address specific and emerging drug

epidemics and/or underserved populations (e.g., methamphetamine, heroin, designer

drugs, adolescents, specific racial and ethnic groups, exoffenders, homeless persons,

and women on welfare.)

Investment in the application of research findings is also a key Federal responsibility, and CSAT and CSAP, as the lead Federal agencies in treatment and prevention, are singularly equipped to translate research findings into best practices for

treatment and prevention programs.

For fiscal year 2002 we urge Congress to appropriate $350 million each for CSAT

and CSAP, a $94 million increase for CSAT and a $175 million increase for CSAP.

Safe and Drug Free Schools and Communities Act—Department of Education

Research has demonstrated that school-based prevention programs that focus on

personal and refusal skills development can significantly reduce alcohol and drug

use. The Safe and Drug Free Schools program also provides critical intervention

services by supporting student assistance programs that refer students who are beginning to use alcohol and drugs to appropriate services. These early intervention

programs, which have no other source of federal funding, are critical to reaching

youth at high risk early.

For fiscal year 2002 we urge Congress to appropriate $694 million for the Safe

and Drug Free Schools and Communities Act program, a $50 million increase over

fiscal year 2001, with the entire increase be directed into the States Grants program

which supports local community prevention programs.

We also ask that Congress keep the funding for the Safe and Drug Free Schools

and Communities Act program separate from the 21st Century Program. The combination of these two programs would dilute funding directed toward drug and alcohol prevention efforts.

Basic Research—NIH/NIAAA & NIDA

Research into the causes, costs, and ‘‘cures’’ of alcoholism and drug dependence

is an important component of our field’s continuum. This past year NIDA and

NIAAA have been making great strides in research relative to alcohol and drug dependence. These breakthroughs have demonstrated that alcoholism and drug dependence research hones our knowledge about addiction and improves our ability

to treat and prevent it.

To expand our knowledge of addiction and how best to treat and prevent it, we

urge Congress to appropriate $341 million for NIAAA, a $79 million increase, and

$991 million for NIDA, a $211 million increase.

CONCLUSION

Alcoholism and drug dependence continue to be among our Nation’s most serious

and costly public health problems. The programs I have discussed this afternoon are

the first line of defense to protect our children from developing drug and alcohol

problems, as well as the funding source of last resort to treat Americans who have

already developed these problems. As a society, we must strengthen these programs.

Thank you.

PREPARED STATEMENT OF THE LOVELACE RESPIRATORY RESEARCH INSTITUTE (LRRI)

It is proposed that the Department of Health and Human Services (DHHS)

through its constituent agencies, support the renovation of the LRRI clinical facilities and purchase of necessary equipment to support LRRI maintain its high research and clinical standards, better provide appropriate data security.

LRRI has committed to a building campaign using $10 million in private funds

to improve its laboratory facilities and equipment. LRRI’s clinical study facility is

in need of renovation to better accommodate the thousands of outpatients recruited

for these studies and to better maintain security of their patient information. LRRI

requests $2 million to help renovate this facility.

PROJECT IMPACT

LRRI, as a private non-profit research institute, places top priority on its ability

to translate its basic science findings from animal models, into protocols designed

to evaluate new approaches for treating respiratory disease. These protocols lead to

new innovative techniques and approaches to health care.
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LRRI conducts clinical studies requiring the recruitment of thousands of patients

that provide the basis for making the link between genetic and cellular defects and

clinical disease presentation and demographic characteristics. Currently, LRRI is

conducting population-based genetic studies in:

—Chronic obstructive pulmonary diseases (COPD),

—Early detectors for lung cancer,

—Pulmonary fibrosis, and

—Mechanisms of asthma and other lung diseases in Hispanic and Native American children

Two events have greatly enhanced the ability to better understand the mechanisms of human disease in communities. One is the dramatic advance in molecular

and cellular biology over the last 10 years, especially in human genetics. The other

is the ability to collect and process data using advance computer systems and statistical techniques. This process called ‘‘molecular epidemiology’’ makes the link between genetic and cellular defects and clinical disease. LRRI has formed collaborations with national and local a private health providers to collect and manage patient data to carry out their ‘‘molecular epidemiological’’ studies. These partners include, the:

—Lovelace Health Systems (LHS),

—Albuquerque Veterans Administration Medical Center (VA),

—University of New Mexico School of Medicine (UNM), and the

—University of Miami School of Medicine (UMSM).

Given the nature of the clinical studies performed, LRRI’s facility requires security mechanisms well beyond those of ordinary medical clinics. As one can well

imagine, this facility is the repository of very sensitive personal data, including that

linked to an individual’s DNA. To carry out this responsibility for privacy and confidentiality, there is a need to renovate the facilities and equipment necessary to

be physically and electronically impenetrable to all but those who have specific and

authorized access.

The existing 8,000 sq. ft. facility was constructed in the 1950’s and requires renovation and upgrades to provide a suitable, efficient, functional and secure facility.

The proposed project would require reconfigured space, upgrades to meet current

fire and safety codes, new interior finishes, new plumbing, upgraded electrical and

a new heating, ventilation and air conditioning system.

The current clinical trials facility is occupied in part by other LRRI functions.

Some of these functions will need to be relocated to provide the required additional

space for the clinical studies. Unfinished space is being made available in the new

research facility included as part of the $10 million LRRI campaign. The proposed

project will include the completion of 8,000 square feet of the unfinished space for

this purpose.

Accordingly, to meet this responsibility and to improve LRRI’s ability to conduct

its clinical studies, we respectfully request $2 million. The responsible Federal agency is the Health Resources and Services Administration (HRSA).

PREPARED STATEMENT OF THE LYMPHOMA RESEARCH FOUNDATION OF AMERICA, INC.

Chairman Specter, Ranking Member Harkin and esteemed members of the Subcommittee, thank you for this opportunity to present written testimony before you

on behalf of the over 600,000 Americans living with lymphoma and on behalf of the

Lymphoma Research Foundation of America (LRFA). LRFA is the foremost national

nonprofit organization dedicated to funding lymphoma research and providing information, education and support to lymphoma patients and their loved ones.

The organization was founded in 1991 by Ellen Glesby Cohen, whose own experience battling non-Hodgkin’s lymphoma led her to fully appreciate the pressing need

for better, safer cancer treatments. To date, LRFA has awarded $3 million in support of 93 lymphoma research projects. Tragically, Ms. Cohen’s battle with

lymphoma ended in August of last year.

Lymphoma is a cancer that originates in and affects the body’s immune system.

Lymphoma occurs when cells that normally fight infection abnormally multiply and

form tumors. Lymphoma strikes men, women and children of all ages, races and

socio-economic backgrounds.

Three years ago, after a routine physical, my doctor told me that he was concerned about my white blood cell count. It had been high for a while, and he feared

that I might have a form of cancer called Chronic Lymphocytic Leukemia (CLL). He

calmed me by saying that people sometimes lived up to ten years with CLL without

treatment, and referred me to an oncologist at Mayo Clinic for further evaluation.
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After several days of testing at Mayo, the oncologist told me that I had a disease

called Mantle Cell Lymphoma not CLL. I remember vividly that he could not look

me in the eye when he told me there were no known effective treatments for it. I

asked him how long I had to live. He said that I was in the last stage of the disease,

that lymphoma was in every organ of my body, and I could have as little as six to

18 months to live.

Stunned, my wife and I felt lost. We knew nothing about lymphoma. That evening

we walked to a bookstore and started to read. We learned that lymphoma is a cancer of the lymphatic system, a part of our immune system, and that there are two

main types of lymphoma, Hodgkin’s lymphoma, also known as Hodgkin’s Disease,

and non-Hodgkin’s lymphoma (NHL). We learned that about 80 percent of people

diagnosed with Hodgkin’s disease, with treatment, survive for at least five years.

The prognosis is quite varied for non-Hodgkin’s lymphomas, the category I am in,

for NHL is a more complex group of cancers. There are more than 30 subtypes of

non-Hodgkin’s lymphoma that range from slow growing, or indolent, to highly aggressive. Some non-Hodgkin’s lymphomas are considered curable. The majority are

not curable, but are treatable. With mine, we discovered that statistically, whether

you treat it or not, you live the same amount of time. In the complexity that I have

described lays our challenge. No one knows what causes lymphoma.

According to ‘‘Cancer Facts & Figures’’ published by the American Cancer Society

(ACS), the number of newly diagnosed cases of lymphoid malignancies in 2001 is

estimated to be 89,600 with a 50 percent average mortality rate for all lymphomas.

The ACS also reports that the diagnostic incidence of non-Hodgkin’s lymphoma has

risen a dramatic 80 percent over the last 20 years, making it the second most rapidly rising cancer by rate of incidence in the United States. Furthermore, lymphoma

is the second leading cause of cancer-related deaths. An astonishing 60 percent of

all childhood malignancies are lymphomas, or their cousin, leukemia. According to

the National Cancer Institute (NCI), lymphoma represents the third most frequent

type of cancer in the under 20-age group. Within these statistics, Mr. Chairman, is

an urgent human cry for leadership and focus.

Since receiving my diagnosis three years ago, I have been struck by the almost

academic pace of lymphoma research. The scientists and researchers involved in developing diagnostic and treatment approaches have excellent skills. The federal

budget for cancer research has been increasing, but progress has been too slow, and

there is a notable lack of urgency. To address this situation, Mr. Chairman, the

Lymphoma Research Foundation of America supports the campaign of doubling the

budget of the National Institutes of Health (NIH) by the year 2003.

The National Cancer Institute (NCI) is in the process of completing a Progress

Review Group, or PRG, on lymphoma, leukemia, and myeloma. One purpose of the

PRG is to identify the overlaps in research and where gaps exist. As a participant

in the PRG Roundtable meeting consisting of scientists, clinicians, industry, patient

advocates and federal agencies, it was obvious that cross-disciplinary and multi-institutional research collaboration is needed. This would enable researchers to better

communicate research results and to share resources, reagents, and patients. Ultimately, it would result in quickening the pace of the research itself. The PRG report

produced by this process is designed to create a national prioritized research agenda

for lymphoma and other hematological cancers. But we believe that the recommendations alone will not bring about needed change rapidly enough. Therefore,

we request that a budget plan accompany the report.

In addition, because of the link between lymphoma and environmental, bacterial,

and viral factors, we request the National Institute on Environmental Health

Sciences (NIEHS) to report to Congress on the current state of its research portfolio

on lymphoma and hematological cancers. For fiscal year 2002, we request the Centers for Disease Control and Prevention (CDC) to expand its support in investigating

the possible environmental causes of lymphoma and increase its data collection on

lymphoma to provide accurate statistics on the disease. Both NIEHS and CDC must

also be encouraged to collaborate with NCI and the NIH to avoid overlap in their

research.

Lymphoma is one of the most difficult cancers to diagnose. Indeed, too many people are already in advanced stages of the disease when they receive a diagnosis.

Many people are also misdiagnosed, like I was, as to the type of lymphoma they

have. As a result of the highly complex nature of the disease and the many different

types of lymphoma, we request an outreach campaign by the CDC to educate clinicians and the general public on the symptoms associated with lymphoma and methods to better diagnose this complicated cancer. As you are well aware, early detection and early treatment of cancer increase one’s chance of survival.

I do not believe that the situation for those of us living with lymphoma has to

be bleak. As evidenced by exciting discoveries resulting from the human genome
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project, advances in science and technology have brought us to the brink of an explosion in our understanding of the basic science of human malignancies. We have

also entered into one of the most exciting periods in lymphoma research as more

targeted, nontoxic therapies that attempt to modify the immunologic and genetic abnormalities of lymphomas are developed, such as vaccines, antisense compounds and

gene therapy. Newer technologies will eventually allow physicians to predict more

reliably a patient’s response to treatment and to customize treatment strategies.

I am a beneficiary of this progress. I am currently participating in a clinical trial

at the NCI that involves treatment with a vaccine made from my own cancer cells.

But I am one of only 20 participants, and even if successful, this treatment will take

many, many years to reach the thousands who need it.

Many scientists believe that lymphoma, because of its cellular biology and metastatic presentation, is the perfect malignancy in which to explore new avenues of

treatment. Exciting discoveries resulting from lymphoma research, such as

monoclonal antibodies, have the potential to benefit many other cancers, including

those of the breast, prostate, colon and lung. But the technologies and novel therapies I described above are still early in their development and have to surmount

considerable obstacles before they become available to treat patients. There is still

a critical need for more innovative research and collaborative efforts before our goal

of more effective, safer treatments, and ultimately, cures for lymphoma and other

cancers can be achieved. And that is why I am asking you today to continue to increase your support of lymphoma research and to further the extraordinary research

opportunities and momentum created by this moment.

Lymphoma is the only cancer with an increasing mortality rate, in contrast to the

decreasing mortality rates of many other cancers. I do not believe that we should

consider this statistic as something beyond our control, and therefore, tragic but acceptable. In 1998, LRFA founder, Ellen Glesby Cohen, testified before this subcommittee. At that time, approximately 800 people per week died of lymphoma. This

year, about 1,000 people per week will die. It is my hope that this subcommittee

will provide the leadership and means to reverse these trends.

Thank you for the opportunity to present written testimony and share my story

with you.

PREPARED STATEMENT OF THE MEDICARE PAYMENT ADVISORY COMMISSION

The Medicare Payment Advisory Commission (MedPAC) requests a budget appropriation of $8,250,000 for fiscal year 2002: the same amount as fiscal year 2001,

plus $250,000 to cover the costs of an anticipated mandatory office relocation. This

level of funding will enable the Commission to complete the range of reports assigned to it by the Congress under recent legislation, as well as to provide technical

support on Medicare policies to congressional committees and staff. This testimony

will discuss MedPAC’s statutory mandate, our work in fulfillment of that mandate

during fiscal years 2000 and 2001, the work we have planned in fiscal year 2002,

and the resources we will need to pursue that work.

LEGISLATIVE MANDATE

The Congress established MedPAC in the Balance Budget Act of 1997 (BBA) as

an independent legislative agency to provide analysis of and recommendations on

policies affecting the Medicare program. The Commission consists of 17 Commissioners appointed to three-year terms by the Comptroller General. By law, Commissioners are appointed to represent diverse points of view, including those of health

care providers, payers, consumers, and employers, and to bring expertise in health

economics and biomedical and health services research. (See Table 1 for a listing

of the Commission’s members and their affiliations).

The Commission is assisted in its work by an executive director and professional

research and administrative staff. Our professional staff have expertise in health economics, statistics, public policy, public health, hospital administration, medicine,

and law. When specialized data or expertise are needed, the Commission also contracts with government agencies, trade associations, and private research firms.

Within its broad mandate, MedPAC is directed by law to consider specific issues

relating to the Medicare program. We are charged with considering:

—Medicare payment, risk adjustment, risk selection, quality of care, access to

care, and other major issues relating to the implementation and development

of the Medicare∂Choice program;

—methods to determine and update payments for different types of health services under the traditional fee-for-service Medicare program;
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—the impact of payment policies on access to and quality of care for beneficiaries

in the traditional program;

—the effect of Medicare payment policies on the broader health care system; and

—the effect of developments outside the program on Medicare.

The law directs the Commission to make recommendations to the Congress on

Medicare’s payment policies by March 1 of each year. MedPAC also must submit

a report to the Congress addressing other issues relating to the Medicare program

by June 15 of each year. In addition, the Commission is required to comment on

reports submitted by the Secretary of Health and Human Services to the Congress.

Finally, MedPAC must submit additional reports on specific topics of interest at the

direction of the Congress. Eighteen reports were assigned to the Commission under

the Balanced Budget Refinement Act of 1999 (BBRA), and an additional 11 under

the Medicare, Medicaid, and the SCHIP Benefits Improvement and Protection Act

of 2000 (BIPA).

The Commission meets about eight times a year to review analyses presented by

staff and to develop and discuss its recommendations. These meetings are open to

the public, with time routinely provided for public comment.

ACCOMPLISHMENTS DURING FISCAL YEARS 2000 AND 2001

MedPAC fulfills its mandate to assist the Congress in improving Medicare policy

in a number of ways:

—reports to the Congress required by our authorizing legislation or by other laws,

—formal testimony before the authorizing Committees of the House and the Senate,

—formal comments to the Secretary of Health and Human Services on proposed

regulations, and

—technical analyses and briefings by Commission staff for congressional staff.

Statutorily required reports

The Commission submitted its March 2001 report to the Congress on time. This

report contained the Commission’s recommendations concerning Medicare payment

policy issues and presented supporting analyses and reasoning behind the Commission’s views. The report addressed the following areas:

—evaluating Medicare’s payment policies,

—updating payments for physician services and for care provided in hospital outpatient departments,

—accounting for new technology in hospital prospective payment systems (PPS),

—developing input-price indexes for all health care settings,

—financial performance and inpatient payment issues for PPS hospitals,

—prospective payment for post-acute care,

—reconciling Medicare∂Choice payments and fee-for-service spending,

—end-stage renal disease payment policies in traditional Medicare,

—reducing beneficiary coinsurance under the hospital outpatient prospective payment system, and

—treatment of the initial residency period in Medicare’s direct graduate medical

education payments.

The Commission will submit its second mandated report for the year on June 15,

2001. This report focuses on the Commission’s examination of issues affecting the

Medicare program in rural areas. The June report will include the following topics:

—overview of rural markets and Medicare,

—rural beneficiaries’ access to care,

—prospective payment for hospitals in rural areas,

—home health payment issues,

—prospective payment systems for outpatient hospital services,

—Medicare∂Choice in rural areas, and

—quality of care issues for rural beneficiaries.

This report will address several issues MedPAC was directed to study under the

BBRA, including:

—the appropriateness of prospective payment for home health agencies in rural

areas,

—the adequacy of Medicare’s payment provisions for rural providers,

—the appropriateness of prospective payment for rural psychiatric hospitals, and

—the appropriateness of applying the prospective payment system for hospital

outpatient departments to certain rural hospitals.

The June report will also include MedPAC’s review of the sustainable growth rate

and conversion factor for physician services, as required by the Congress.

The BBRA required that MedPAC review several policies in Medicare∂Choice

and on Medicare payment for post-surgical recovery care centers. In November
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2000, MedPAC fulfilled these requirements by submitting three reports to the Congress: ‘‘Medical Savings Accounts and the Medicare Program, Improving Risk-adjustment in Medicare, and Medicare Payment for Post-surgical Recovery Care Centers.’’ In May 2001, the Commission will submit reports as required under the

BBRA on Medicare payment for clinical training of non-physician health professionals in hospitals and on payment for skilled nursing facilities in Alaska and Hawaii.

During the next fiscal year, Commission staff will continue to prepare and distribute other reports containing information from its analyses and research requested by the Congress or initiated on its own. Some of these reports will result

from analyses undertaken by the Commission staff; others will contain findings

from research and analyses conducted under external research contracts.

Testimony

During fiscal years 2000 and 2001, the chair of the Commission testified before

the House Committee on Ways and Means, Subcommittee on Health and the House

Committee on Commerce. Her testimony before the Ways and Means Subcommittee

focused on the impact of the BBA on patients, providers and Medicare∂Choice

plans and her testimony before the Commerce Committee addressed the impact of

the BBA on patients and providers. During this period, the executive director testified before the House Committee on Commerce and the Senate Committee on Finance. The executive director’s testimony before the Commerce Committee addressed accounting for new technology in the hospital prospective payment system.

Before the Finance Committee he addressed issues surrounding the Medicare∂Choice program.

In addition, the Commission expects to provide further testimony on subjects related to its expertise during fiscal year 2002. Members of the Commission and staff

will continue to provide briefings, technical advice, and other support to members

of the Congress and their staff. The Commission also works with the Health Care

Financing Administration (HCFA) and a number of private sector groups concerning

Medicare payment for facility and physician’s services and Medicare∂Choice, as

well as broader changes in health care financing and delivery.

Comments on proposed regulations

Since enactment of the BBA, the Commission has closely monitored implementation of the law by the Secretary and has commented on proposed rules and interim

final regulations. Although MedPAC is not required by law to comment on proposed

regulations, we do so in cases where we feel that the Congress benefits from having

an independent assessment. Further, making comments as the regulations are developed provides the Congress (and the Secretary) with more timely advice than we

can provide in our March or June reports. In fiscal year 2000, MedPAC submitted

formal comments on the Secretary’s proposal for the prospective payment system for

home health services.

FUTURE WORK

Our priorities for the upcoming fiscal year include working on our two mandated

reports, focusing on access and quality of care, continuing our work on Medicare in

rural areas, and examining the regulatory complexity of the Medicare program. We

also will continue to monitor the impact of changes in payment for ambulatory care

services including hospital outpatient department and physicians, evaluate payment

policies for post-acute care, and examine issues in Medicare∂Choice.

Other topics the Commission will pursue were defined by the Congress under the

BBRA and the BIPA. These include payments to Medicare∂Choice plans, appropriate quality standards, skilled nursing facility payment, use of and payment for

physician services, examining the use of consumer coalitions in marketing of Medicare∂Choice plans, access to and use of the hospice benefit, Medicare coverage of

services provided by certain allied health providers, the shortage of geriatricians,

and the implications of the hospital-specific cap on residents in Medicare’s graduate

medical education payments. The Commission further anticipates that the Congress

will continue to seek its advice and analytic help in monitoring implementation of

the Medicare provisions of the BBA, the BBRA, and the BIPA, and the Congress

continues work on legislation affecting the Medicare program.

MedPAC’s staff is beginning to develop research projects on these and other topics. Commissioners will meet in July to discuss which projects should be given emphasis and we will discuss our analytic agenda at our public meetings.
587

APPROPRIATIONS REQUEST

As noted above, MedPAC is requesting $8,250,000 for fiscal year 2002, the same

amount as fiscal year 2001, plus $250,000 to cover the costs of an anticipated mandatory office relocation. We propose to allocate a large portion of the requested

funds to external research contracts to support the numerous reports request by the

Congress (see Table 2).

We also plan to target funding towards salaries and benefits in an effort to

achieve the staff size needed to fulfill our responsibilities and to provide the maximum support to Congress. Although, the Commission continued to experience staff

turnover during fiscal year 2001 through aggressive recruiting we have attracted

several highly qualified individuals. Despite a tight labor market for health policy

analysts—particularly senior people with extensive knowledge of the Medicare program—we hope to be fully staffed at the beginning of fiscal 2002 to allow us to fully

respond to the many responsibilities given to us by the Congress.

TABLE 1.—MEMBERS OF THE MEDICARE PAYMENT ADVISORY COMMISSION AND THEIR

AFFILIATIONS

Member Affiliation

Gail R. Wilensky, Ph.D., Chair, Bethesda, MD .............................. Project HOPE, Center for Health Affairs

Joseph P. Newhouse, Ph.D., Vice Chair, Boston, MA .................... Harvard University

Beatrice Braun, M.D., Spring Hill, FL ........................................... American Association of Retired Persons

Autry O.V. ‘‘Pete’’ DeBusk, Powell, TN .......................................... DeRoyal

Glenn M. Hackbarth, J.D., Bend, OR ............................................. Independent consultant

Spencer Johnson, Lansing, MI ....................................................... Michigan Health and Hospital Association

Floyd D. Loop, M.D., Cleveland, OH .............................................. The Cleveland Clinic Foundation

Alan R. Nelson, M.D., Washington, DC ......................................... American College of Physicians—American Society of Internal Medicine

Janet G. Newport, Santa Ana, CA ................................................. PacifiCare Health Systems

Carol Raphael, New York, NY ........................................................ Visiting Nurse Service of New York

Robert D. Reischauer, Ph.D., Washington, DC .............................. The Urban Institute

Alice Rosenblatt, F.S.A., M.A.A.A., Thousand Oaks, CA ................ Wellpoint Health Networks

John W. Rowe, M.D., Hartford, CT ................................................. Aetna US Healthcare

David A. Smith, Washington, DC .................................................. AFL–CIO

Ray E. Stowers, D.O., Tulsa, OK .................................................... Oklahoma State University—College of

Osteopathic Medicine

Mary K. Wakefield, Ph.D., Fairfax, VA ........................................... George Mason University

TABLE 2.—BUDGET AUTHORITY, MEDICARE PAYMENT ADVISORY COMMISSION

[In thousands of dollars]

Object classification

Fiscal year

Change

Fiscal

year

2002

request

2002

actual

2001

plan

Salaries:.

Full-time staff ............................................................. $2,439 $2,911 ................ $2,911

Commissioners ............................................................. 152 182 ................ 182

Subtotal ................................................................... 2,591 3,093 ................ 3,093

Benefits ................................................................................. 631 760 ................ 760

Travel:.

Staff ............................................................................. 37 31 ................ 31

Commissioners ............................................................. 77 100 ................ 100

Subtotal ................................................................... 109 131 ................ 131
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TABLE 2.—BUDGET AUTHORITY, MEDICARE PAYMENT ADVISORY COMMISSION—Continued

[In thousands of dollars]

Object classification

Fiscal year

Change

Fiscal

year

2002

request

2002

actual

2001

plan

Standard level user charges ................................................ 349 355 ................ 355

Mainframe computer ............................................................ 941 755 ................ 755

Telephone .............................................................................. 56 50 ................ 50

Postage ................................................................................. 53 90 ................ 90

Subtotal ................................................................... 1,050 895 ................ 895

Printing and reproduction .................................................... 160 250 ¥$32 218

Computer programming ........................................................ 870 900 ................ 900

Research contracts ............................................................... 590 1,230 ¥30 1,200

Commercial contracts ........................................................... 222 230 ∂250 480

Government contracts ........................................................... 1 1 0 1

GSA support .......................................................................... 60 66 ∂2 68

Subtotal ................................................................... 1,743 2,427 ∂222 2,649

Supplies ................................................................................ 38 38 ................ 38

Publications .......................................................................... 34 33 ................ 33

Subtotal ................................................................... 72 71 ................ 71

Equipment and furnishings .................................................. 23 18 ∂60 78

Lapsing ................................................................................. 230 ................ ................ ................

Total ........................................................................ 7,015 8,000 ∂250 8,250

Note.—Numbers may not add to totals because of rounding.

PREPARED STATEMENT OF THE MEDICAL LIBRARY ASSOCIATION AND THE ASSOCIATION

OF ACADEMIC HEALTH SCIENCES LIBRARIES

INTRODUCTION

Mr. Chairman, thank you for the opportunity to submit testimony on behalf of the

Medical Library Association (MLA) and the Association of Academic Health Sciences

Libraries (AAHSL) regarding the fiscal year 2002 budget for the National Library

of Medicine (NLM). I am Marianne Comegys, associate professor of medical library

science at the Louisiana State University Health Sciences Library in Shreveport,

La.

MLA is a professional organization, headquartered in Chicago, representing over

4,000 individuals and 1,200 institutions involved in the management and dissemination of biomedical information to support patient care, education and research. In

1998, the organization celebrated its 100th anniversary.

AAHSL, is comprised of the directors of libraries of 142 accredited United States

and Canadian medical schools belonging to the Association of American Medical Colleges. Together, MLA and AAHSL address health information issues and legislative

matters of importance to the medical library community through a joint legislative

task force.

Mr. Chairman, the National Library of Medicine, on the campus of the National

Institutes of Health in Bethesda, Maryland, is the world’s largest medical library.

The Library collects materials in all areas of biomedicine and health care, as well

as works on biomedical aspects of technology, the humanities, and the physical, life,

and social sciences. The collections stand at 5.8 million items—books, journals, technical reports, manuscripts, microfilms, photographs and images. Housed within the

Library is one of the world’s finest medical history collections of old and rare med-
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ical works. The Library’s collection may be accessed in the reading room or requested on interlibrary loan. NLM is a national resource for all U.S. health science

libraries through a National Network of Libraries of Medicine.

On behalf of the medical library community, I would like to thank the subcommittee for its leadership in securing a 15 percent increase for NLM in fiscal year

2001. With respect to the Library’s budget for the coming fiscal year, I would like

to touch briefly on four issues; (1) NLM’s basic services, (2) NLM’s outreach and

telemedicine activities, (3) NLM’s PubMed Central and clinical trials databases, (4)

and NLM’s facilities needs.

THE GROWING DEMAND FOR NLM SERVICES

Mr. Chairman, it is a tribute to NLM that the demand for its services continues

to steadily increase each year. An average of 250 million Internet searches (30 percent from the general public) are performed annually on NLM’s MEDLINE database, which provides access to the world’s most up to date health care information.

Moreover; medical libraries, academic health centers, hospitals, community health

centers, veterans health care facilities, and private physicians rely heavily on NLM

and its National Network of Libraries of Medicine to deliver quality health care everyday.

NLM also plays a critical role in maintaining the integrity of the world’s largest

collection of medical books and journals. Increasingly, this information is in digital

form, and NLM, as a national library responsible for preserving the scholarly record

of biomedicine, is developing a strategy for selecting, organizing, and ensuring permanent access to digital information. Regardless of the format in which the materials are received, ensuring their availability for future generations remains the

highest priority of the Library.

Mr. Chairman, simply stated, NLM is a national treasure. I can tell you that

without NLM our nation’s medical libraries would be unable to provide the type of

information services that our nation’s health care providers, educators, researchers

and patients have come to expect.

Recognizing the invaluable role that NLM plays in our health care delivery system, the Medical Library Association and the Association of Academic Health

Sciences Libraries join with the Ad Hoc Group for Medical Research Funding in recommending a 16.5 percent increase for NLM and NIH overall in fiscal year 2002.

NLM’S OUTREACH AND TELEMEDICINE ACTIVITIES

Outreach and Education

NLM’s outreach programs are of particular interest to both MLA and AAHSL.

These activities, designed to educate medical librarians, health care professionals

and the general public about NLM’s services, are an essential part of the Library’s

mission.

The need for enhanced outreach activities has grown significantly in recent years

following NLM’s decision to make its MEDLINE database available for free over the

World Wide Web. The Library has taken a leadership role in promoting educational

outreach aimed at public libraries, secondary schools, senior centers and other consumer-based settings. We were pleased that the Committee again last year recognized the need for NLM to coordinate its outreach activities with the medical library

community.

Mr. Chairman, we applaud the success of NLM’s outreach initiatives and look forward to continuing our work with the Library again in fiscal year 2002 on these

important programs.

Telemedicine

Mr. Chairman, telemedicine continues to hold great promise for dramatically increasing the delivery of health care to underserved communities across the country

and throughout the world. NLM has sponsored over 50 telemedicine related projects

in recent years, including 21 multi-year projects located in various rural and urban

medically underserved communities. These sites serve as models for:

—Evaluating the impact of telemedicine on cost, quality, and access to health

care;

—Assessing various approaches to ensuring the confidentiality of health data

transmitted via electronic networks;

—Testing emerging health data standards.

Mr. Chairman, it is clear that telemedicine will play a major role in the delivery

of health care in the 21st Century. Medical librarians and health information specialists have an important role to play in supporting this revolutionary approach to
590

health care and we encourage Congress and NLM to continue their strong support

of telemedicine in our nation’s medically underserved areas.

PUBMED CENTRAL /CLINICAL TRIALS DATABASE

The medical library community applauds NLM for its leadership in establishing

PubMed Central, an online repository for life science articles introduced in early

2000. PubMed Central evolved from an electronic publishing concept proposed by

former NIH Director Dr. Harold Varmus. The site houses articles from the Proceedings of the National Academy of Sciences, the American Society for Cell Biology’s journal Molecular Biology of the Cell, and other publications.

This new online resource will significantly increase access to biomedical information by health care professionals, students, researchers and the general public. The

medical library community believes that health sciences librarians have a key role

to play in the further development of PubMed Central. Because of the high level

of expertise health information specialists have in the organization, collection, and

dissemination of medical literature, we believe our community can assist NLM in

issues related to copyright, fair use, and information classification on the PubMed

Central site. We look forward to collaborating with the Library as this exciting new

project continues to unfold this year.

Mr. Chairman, I also want to comment on another relatively new service offered

by NLM—its clinical trails database (Clinicaltrials.gov). This listing of some 5,200

federal and privately funded trials for serious or life-threatening diseases was

launched in February of 2000. This free service is currently logging more than 2

million page hits a month and is an invaluable resource to patients and families

interested in participating in cutting edge treatments for serious illnesses. The medical library community congratulates NLM for its leadership in creating

ClinicalTrials.gov and looks forward to assisting the Library in anyway possible

to advance this important initiative. This database is a nice compliment to NLM’s

extremely successful consumer web-site MEDLINEplus, which now covers over 450

health topics.

NLM’S FACILITIES NEEDS

Mr. Chairman, over the past two decades NLM has assumed several major new

responsibilities particularly in the areas of biotechnology, health services research,

high performance computing, and consumer health. As a result, the Library has had

tremendous growth in its basic functions related to the acquisition, organization,

and preservation of an ever-expanding body of biomedical literature.

This increase in the volume of biomedical information as well as Library personnel (NLM currently houses over 1,100 people in building built to accommodate

650) has resulted in a serious shortage of space at the Library. In addition, the National Center for Biotechnology Information at NLM builds sophisticated data management tools for processing and analyzing enormous amounts of genetic information critical to advancing the Human Genome Project.

In order for NLM to continue its mission as the world’s premier biomedical library, a new facility is urgently needed. The NLM Board of Regents has assigned

the highest priority to supporting the acquisition of a new facility. The medical library community is pleased that Congress last year appropriated the necessary architectural and engineering funds for facility expansion at NLM. We encourage the

subcommittee to continue to provide the resources necessary to acquire a new facility and to support the Library’s health information programs.

Mr. Chairman, thank you once again for the opportunity to present the views of

the medical library community.

PREPARED STATEMENT OF THE MENDED HEARTS, INC.

I am Robert H. Gelenter, the legal representative for the Mended Hearts Inc, a

national heart disease patient support group of 25,000 members across the country.

We visit patients in about 450 hospitals throughout the United States. I have been

appointed by the group to assist in this lobbying effort—a volunteer position.

More than 25 years ago, I was diagnosed with a rare heart disease. After having

severe chest pains and trouble breathing for more than two years, I was diagnosed

with hypertrophic cardiomyopathy, a disease in which the heart enlarges. The heart

muscle eventually thickens so much that it can’t pump blood effectively and does

not grow in the normal parallel patterns. More than 35 percent of young athletes

who die suddenly die from this disease. But, it affects men and women of all ages.

It is sudden and one of the things known about this disease is sudden cardiac death.
591

There is no cure for this disease. Medication may work and there is surgery that

may or may not alleviate the pain. If that doesn’t work a patient may need a heart

transplant, yet spare organs are scarce. The doctor who made my diagnosis was

trained at the National Heart, Lung, and Blood Institute of the National Institutes

of Health.

Initially, I received several medications which allowed me to engage in most activities. But, some activities, such as walking up hills, gave me problems like shortness of breath and severe chest pains. But, generally I could function normally.

However, after about 10 years, the discomfort was increasing, and it became apparent that I was in serious trouble. I could not walk sixty feet without having to stop

to catch my breath. Sometimes the pain was so great that I would almost double

over in the middle of the street. My wife told me that my face would become gray.

The perspiration would pour off by body. If I was lucky I could find a chair to sit

on. The quality of my life had deteriorated so drastically that I knew I needed some

treatment.

Finally in 1988, I went to Georgetown University Medical Center for an

angiogram—the gold standard for diagnosing heart problems. The cardiologist who

performed the angiogram told me that he had bad news and worse news. The bad

news was that I had a 95 percent blockage in my left anterior descending heart artery—the so-called ‘‘widow makers spot.’’ The worse news was that I had a major

chance of having a major heart attack with a less than a 5 percent chance of surviving that heart attack because of the hypertrophic cardiomyopathy. At this point,

my wife was quietly crying and I was perspiring profusely. Since Georgetown University Medical Center did not have the expertise to operate on me, they called the

NIH to see if they would accept me as a patient. I was sent home pending notice

from the NIH.

My parents begged me to go to New York or San Francisco for second opinions.

But, I knew that I had run out of alternatives. No matter what the result, I needed

treatment and I needed it immediately.

I was accepted by the NIH. After entering the National Heart, Lung, and Blood

Institute on February 6th, I was operated on February 11th, 1988. No matter how

trite the expression—that was the first day of the rest of my life. The surgery, considered drastic and rare, is still considered the gold standard throughout the world

for the treatment of hypertrophic cardiomyopathy. The Murrow Procedure, in honor

of the creator, was developed and improved at the NIH.

Although this surgery is no longer performed at the National Heart, Lung, and

Blood Institute, there is another experimental ongoing protocol in which the same

effect is being attempted by using alcohol to deaden the excessive heart tissue.

Now, I am on medication for the rest of my life. My condition is progressive. Five

years ago, I was fitted with a pacemaker to insure that my heart beats at the correct rate. I am 100 percent dependent on this pacemaker. Without the pacemaker,

there are times when my normal heart beat is so slow that I would die.

I am eternally grateful to the physicians funded by the National Heart, Lung, and

Blood Institute, particularly to Dr. MacIntosh and his staff, for the gift of life. Because of this marvelous research supported by the NHLBI, I have lived 13 years

pain free. I have seen two children graduate from college and three grandchildren

born, I have shared these years with a wonderful wife. I have been able to work

at my profession—an attorney at law.

I have had the gift of life restored to me. So to express my gratitude for that gift,

I visit patients recovering from heart episodes at two hospitals, Washington Hospital Center and Washington Adventist Hospital.

I ask for a doubling of the fiscal year 1998 National Heart, Lung, and Blood Institute budget by fiscal year 2003. As the fourth increment toward reaching that goal,

I advocate a fiscal year 2002 appropriation of $2.679 billion for the NHLBI, including $1.650 billion for its heart disease and stroke-related budget.

My experience is the proof that the research supported by the Institute benefits

not just the patients at the NIH Clinical Center, but throughout the United States.

The benefits go worldwide as well.

Heart attack, stroke and other cardiovascular diseases remain the No. 1 killer and

major cause of disability of men and women in the United States. Nearly 41 percent

of people who die in the United States die from cardiovascular diseases. This year,

nearly 950,000 Americans will die from cardiovascular diseases, including more

than 150,000 under the age of 65.
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PREPARED STATEMENT OF MIAMI CHILDREN’S HOSPITAL

In recognition of the indispensable role that independent children’s hospitals, like

Miami Children’s Hospital, play in children’s health, I urge you to continue the commitment to the Children’s Hospital Graduate Medical Education (‘‘GME’’) program

by calling for and supporting full funding this year.

As President and Chief Executive Officer of Miami Children’s Hospital, I am very

concerned about the cut in funding the Administration is proposing for the GME

program this year. The Children’s Hospital Graduate Medical Education program

provides funding to about 60 independent children’s hospitals that were left out of

a GME financing system that depends on Medicare. Children’s hospitals do not

qualify for Medicare GME support which leaves a gap of $285 million annually. As

you know, Congress passed legislation in 1999 to address this inequity. The $235

million authorized last year takes a big step in the right direction to reaching the

$285 million goal. Achieving an appropriation of $285 million this fiscal year will

make an essential investment in the children’s hospitals’ missions as centers of education and research, and regional centers of excellence.

Instead of moving towards that goal, the Administration has announced that the

President’s budget will propose a 15 percent cut, an equivalent of $35 million, for

GME payments to children’s hospitals. Independent children’s hospitals make up

only one percent of all hospitals, train thirty percent of pediatricians, fifty percent

of specialists, and a larger portion of pediatric researchers. Despite these significant

contributions, the survival of these institutions is contingent upon reaching the $285

million goal and thus closing the gap.

I look forward to your continued support for GME funding.

Miami Children’s Hospital (MCH) hereby submits for the record, testimony regarding the need to develop a significant Ambulatory Care Center at Miami Children’s Hospital.

Miami Children’s Hospital is a private, non-profit entity that offers a full range

of services from birth to age 21 with primary care pediatrics as the cornerstone.

Also, MCH is the largest provider of Pediatric Orthopedics in Miami Dade County.

By percentage of net revenue, Miami Children’s Hospital is the largest Medicaid

provider for children in the state of Florida. The services include preventive medicine, the only children’s hospital in Florida with such a department, and the most

sophisticated medical and surgical tertiary care.

Miami Children’s Hospital is South Florida’s only independent, free-standing licensed specialty hospital exclusively for children. Our mission to provide excellent

family centered health care has helped us pave the way to our continuing success.

Some of the success along our path include: being the only children’s hospital in

Florida to successfully separate conjoined twins; it is the leading child neurological

facility in the region. Furthermore, MCH houses the only pediatric cardiac intensive

care unit in the Southeastern United States. It is one of only 10 centers nationwide

selected to participate in the clinical trial of CardioSEAL, a revolutionary closure

device to be used in treating children with atrial septal defects. It was successfully

completed in its first clinical trial.

The Hospital is also very pleased to have been ranked first in Florida, second in

Southeast and tied 14th in the country as top hospital by Child Magazine. This recognition highlights our dedication to pediatric excellence and focuses on the outstanding work taking place in South Florida. For example, MCH is the first hospital

in the state of Florida to have pediatric Extra Corporeal Membrane Oxygenation

(ECMO) available. This procedure allows children born with certain system failures,

such as renal or cardio-pulmonary, to have an effective oxygenation of blood while

recovering. In addition, Miami Children’s Hospital has been the first in the United

States and in the international arena in spearheading many procedures. For instance, it was the first in the United States to perform a tracheal transplant. It was

first in the Southeastern United States to perform a tracheal transplant. It was first

in the Southeastern United States in performing reconstructive surgery for brachial

plexus injuries as well as in repairing Pectus Excavatus (sunken chest). MCH also

performed the world’s first extracardiac Fontan operation that did not require

cardiopulmonary bypass, i.e., the need of heart lung machine, and the world’s first

endoscopic ventricular thrombectomy, i.e., removal of cardiac clot without surgery.

It also led the world’s first conference on minimally invasive surgery for congenital

heart disease and hosted the first Youth Leadership Conference on Health. MCH

is also credited with developing the first international medical teleconference in pediatrics. It was first in the United States and the Americas to use the Helex Septal

Occluder to treat atrial septal device (ASD), a common heart defect.

Miami Children’s Hospital is dedicated to the development of technology that will

be less invasive to children. Always at the forefront of cutting-edge technology, most
593

recently, MCH created a pediatric brain tumor center. The cornerstone of the new

center will be a powerful new tool for treating brain cancer: an interoperative magnetic resonance imaging (MRI) unit that can be rolled into the operating room to

provide surgeons with real-time scans of the child’s brain. The resulting accuracy

will bring new levels of confidence to parents and doctors that all of the tumor has

been removed.

The demand for pediatric care services has grown enormously, especially in Miami

Dade County, since MCH is the only hospital exclusively for children in the region

and indeed in South Florida. To meet these growing needs, we are presently engaged in the construction of a new Ambulatory Care Center that will serve to meet

the needs of a growing population of our patients. The three story Ambulatory Care

Building would provide patient services for the following pediatric specialties: Orthopedics, Rheumatology, Urology, Nephrology, Urodynamic Laboratory, Enuresis

Center, Dermatology, Neurosciences, Behavioral Health, and Pediatric Dentistry.

Our goal to meet the growing demand for children’s services helped create the

Miami Children’s Hospital Dan Marino Center in South Florida. An extension of

MCH, it is an integrated neuro developmental center specializing in the diagnosis

and treatment of children at risk for developmental and psychological problems.

Even with such innovative technologies and procedures, MCH still finds itself unable to meet the growing needs of children. Miami Children’s Hospital treats more

than 185,000 children each year. The Hospital is faced with severe waiting list challenges, for certain services (i.e. child neurological services) the wait can be up to six

weeks or more. The Hospital has for two decades made investments through its own

services, as well as through community-based contributions.

A major component of Miami Children’s Hospital is its mission and commitment

to early intervention and preventive medicine. Miami Children’s Hospital’s mission

is on track to become a leading pediatric preventive medicine institute in the United

States. For example, Miami Children’s Hospital has established mobile pediatric

health vans called the ‘‘Health-on-Wheels’’ program to reach underserved and disadvantaged areas. Since September 1995, two 40-foot, mobile Health-on-Wheels vehicles carrying state-of-the-art medical and dental facilities, in the hands of boardcertified pediatricians, pediatric nurse practitioners, nurse assistants and paramedics, have served over 22,000 children in Dade and Monroe counties. As of 1998,

the Program has administered 13,510 immunizations, 4,129 tuberculosis screens

and 8,721 hearing and vision tests. Of the 14,000 children evaluated, 11 percent

were diagnosed with an acute medical condition.

The Hospital has a state-of-the-art critical care transport service for patients in

need of specialty care using ground ambulance, helicopter or fixed-wing aircraft

called ‘‘LifeFlight’’. The helicopter is one-of-a-kind in that it can transport two patients, travel up to a 200 mile radius and is configured with state-of-the art medical

technology. LifeFlight is used in conjunction with other transportation to bring patients from Florida, as well as world-wide to the Hospital.

Miami Children’s Hospital has excellent clinical services, medical research and a

comprehensive teaching program for doctors, nurses and medical specialists. The

Hospital has eliminated the need to send Florida’s children elsewhere to get the

medical attention they so desperately need. Additionally, Miami Children’s Hospital

offers array of services that draw children world-wide to the Hospital. Programs

that have been established at Miami Children’s Hospital can be used in other parts

of the United States.

Moreover, area hospitals are sending their patients to Miami Children’s Hospital

because of its focus on early intervention and treatment, especially given their specialization in developmental disabilities, as well as the use of the Hospital’s expansive imaging equipment. There is no need to send Florida’s children elsewhere to

get the medical attention they so desperately need.

As you know, funding to improve health care services and access to health care

facilities for children has been a priority for Congress. Therefore, we would appreciate any assistance you may be able to render to ensure that children in need of

special care receive the quality care they deserve, by including $4 million for the

Miami Children’s Hospital Ambulatory Care Center in the fiscal year 2002 Labor,

Health and Human Services, and Education Appropriations Bill.

The estimated cost of construction for the entire Ambulatory Care Center is $13.2

million. We are requesting that approximately $4 million dollars of this cost be

funded by the federal government, possibly through the Health Resources and Services Administration’s Facilities account. The balance of the funding for the project

will be supported as follows: one-third through philanthropic contributions via the

Miami Children’s Hospital Foundation and one-third through operating money generated by the hospital.
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Miami Children’s Hospital wishes to express its deep appreciation to this Committee for permitting us to submit this presentation on Miami Children’s Hospital’s

Ambulatory Care Center. Your positive response for Miami Children’s Hospital’s request for support will have a positive impact on the health and well-being of our

children in need.

Thank you.

PREPARED STATEMENT OF THE MISSISSIPPI DEPARTMENT OF REHABILITATION

SERVICES

Thank you for the opportunity to present testimony for the record on an issue

vital to Americans with disabilities—the need for adequate funding for every state’s

vocational rehabilitation program.

Established in 1920, the Public Vocational Rehabilitation Program (VR) is the cornerstone of our nation’s commitment to people with disabilities toward becoming

economically independent. Last year, the vocational rehabilitation program assisted

235,000 Americans with disabilities to go to work. The combined income of these

235,000 individuals during their first year of employment was a staggering $3.1 billion. Vocational Rehabilitation works!

However, the current federal funding formula threatens to slam shut the door of

opportunity for a vast number of these citizens. While a mandatory cost-of-living adjustment applies to the entire program, a different formula prescribed in the Rehabilitation Act (as amended by the Workforce Investment Act of 1998) applies to how

funds are allocated to the states. For example, while the national program has received annual two to three percent cost-of-living (COLA) increases from Congress

during the past eight years, many states have gotten less than the COLA during

each of those years. Specifically, in Federal fiscal year 2000, 22 states (including

Mississippi) received less than the 1.24 percent COLA increase, and six actually received fewer dollars during Federal fiscal year 2000 than in Federal fiscal year

1999. A majority of states—29 in all—received less than the Federal fiscal year 2001

COLA of 2.6 percent provided in the Congressional appropriation. Unless the formula is fixed, more will follow.

Compounding this problem is the fiscal pressure exerted on the vocational rehabilitation program. For example:

—The success of the Individuals with Disabilities Education Act (IDEA) means

that more young adults than ever before are entering the vocational rehabilitation program for post-secondary training leading to employment.

—Post-secondary tuition has skyrocketed to 200–300 percent above any COLA increase.

—Medical costs are inflating at an alarming rate and will continue to do so.

—The use of assistive technology (such as computerized wheelchairs) in the rehabilitation of Americans with disabilities involves significant expense.

—Because of Welfare-to-Work, the Ticket to Work/Workforce Incentives Improvement Act and the Workforce Investment Act, a large pool of previously unemployed adults is now entering the workforce.

Americans with disabilities have high expectations for the future. They’re becoming better educated and eagerly expect to work in competitive, skilled jobs. As a nation, we have an obligation to ensure that every citizen is able to attain the dignity

that comes with employment and self-reliance.

With the projected Consumer Price Index (CPI) for Federal fiscal year 2002 at 3.4

percent, and without some language to hold states harmless from the application

formula, more than 20 states will fall short of this CPI and thousands of Americans

with disabilities won’t receive the services they need to go to work.

It was never the intent of Congress that any state should receive less than a

COLA increase. On behalf of Americans with disabilities, I respectfully request that:

—the attached ‘‘Amendment for Appropriations for Vocational Rehabilitation’’ language be adopted;

—every state receive ‘‘hold harmless’’ protection at the actual percentage of the

cost-of-living increase so that no state loses federal dollars, as happened during

fiscal year 2000;

—an additional appropriation of $19.1 million be made to the vocational rehabilitation program to remedy the COLA problem; and

—each state receive a 5 percent increase in new federal funds (above the COLA)

to meet the increasing demands upon its vocational rehabilitation program.

The very future of Americans with disabilities is at stake. Thank you for this opportunity to express my concerns and solutions.
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PREPARED STATEMENT OF THE NATIONAL ALLIANCE TO END HOMELESSNESS

The National Alliance to End Homelessness is a national membership organization with nearly 2,000 members around the country. Most are local nonprofit community-based and faith-based organizations that are doing the hands-on work to

end homelessness for families and individuals. As our name implies, our primary

focus is ending homelessness, not simply making it easier to manage. There is nothing inevitable about homelessness in the United States. We know more about homelessness and how to address it than we ever have before. We know what program

models are effective for what kinds of people. It remains only to bring these solutions to a scale commensurate with the problem, and to focus them on bringing

homelessness to an end.

It is our contention that an end to homelessness is a goal that we can achieve

by the end of the decade. To do so we need to pursue four lines of attack simultaneously. We must:

—Plan for outcomes

—Close the front door in to homelessness

—Open the back door out of homelessness and in to housing

—Build the infrastructure.

PLANNING FOR OUTCOMES

We have an extensive system for dealing with homelessness. Too often, however,

this system focuses only on managing the problem and not on a permanent solution.

To change this focus we need to be sure we have accurate information on who homeless people are, how they become homeless, and what works to allow them to secure

and stay in housing. Most homeless people have some contact with mainstream social services programs; indeed, a 1996 study funded by the Interagency Council on

the Homeless found that 62 percent of currently homeless people in families, and

22 percent of those single, were receiving some type of income-based government assistance.

Recommendation: Encourage all programs to collect information about housing

status among those the program serves.—Over the past few years this subcommittee

has encouraged agencies that oversee large ‘‘mainstream’’ (i.e. not homeless-targeted) programs to pay attention to the amount of homelessness among the populations they serve. This has led to important work by the agencies involved, to examine ways to make these programs more conscious of housing stability as an end

to be achieved. More remains to be done, and the subcommittee should continue its

diligence in this regard. State agencies administering TANF, and recipients of substance abuse and mental health block grants should, at a minimum, be required to

monitor and report on clients’ housing status, as the success of their programs depends greatly on housing stability.

Recommendation: Encourage TANF, Foster Care and Substance Abuse and Mental

Health block grant reporting agencies to include a description of preventing and ending homelessness in their annual State plans.—Many homeless people come from

these systems of care. The homeless assistance system, while it provides temporary

housing services for people while they are homeless, can not stop the flow of people

entering its doors. Rather, the mainstream programs should be aware of the integral role they play in preventing and ending homelessness.

Recommendation: Require recipients of PATH, GBHI, and Healthcare for the

Homeless program funds to implement and participate in homeless management information systems.—Many communities are implementing ‘‘homeless management

information systems’’, and some have integrated data collection across systems of

service (i.e. shelters, criminal justice, psychiatric facilities). Recipients of HUD targeted homeless funds are required to collect data on homelessness in order to prevent duplicate counting of homeless persons, and to analyze their patterns of use

of assistance. PATH, GBHI and Healthcare for the Homeless grantees should also

be collecting the data necessary to properly serve the homeless population, and

therefore more effectively expend limited resources.

CLOSING THE FRONT DOOR IN TO HOMELESSNESS

We need to hold government-funded systems accountable for, at the very least,

ensuring that the Americans they serve do not become homeless. We must treat

homelessness among people with mental illness as sign that the mental health system needs improvement; homelessness among former foster children as a similar

sign for the child protection system; homelessness among people with addiction disorders for the substance abuse treatment system.
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Recommendation: No tolerance for discharge into homelessness from residentiallybased programs in HHS.—No system of care should be discharging people into

homelessness. The homeless assistance system is not large, or well-funded, enough

to accommodate people being shifted out of other systems of care, nor should it be.

We need to make mainstream systems more accountable in order to close the front

door into homelessness. Some localities—after recognizing the cost shifting occurring

between various publicly-funded institutions—have started to implement discharge

planning as requisite and/or part of performance goals. Every locality should be required to follow suit.

OPENING THE BACK DOOR OUT OF HOMELESSNESS AND INTO HOUSING

Most people who become homeless find housing on their own in relatively short

order. We need to speed up that process, and prevent disruptions during the period

of homelessness. A minority, however, remains homeless for a long time. Among this

group, disabilities are prevalent, including mental illness, substance addiction, and

HIV/AIDS. Most of the chronically homeless, therefore, are already being served by,

or are eligible for, services funded by the Department of Health and Human Services.

This subcommittee’s work can have a huge impact on efforts to rehouse people

who are chronically homeless and chronically ill. Besides housing, they need treatment and services:

—Outreach, particularly to long-term homeless people with mental health and

substance abuse problems, to ensure that they make use of the services that

are available.

—Short-term treatment in a residential setting aimed at stabilizing these individuals and transitioning them into permanent housing.

—Treatment and long-term aftercare linked with permanent housing, creating

permanent supportive housing, a powerful model that improves the lives of

long-term homeless people while saving public money that would otherwise be

spent on hospital emergency rooms, emergency detoxification, acute mental

health care, shelters and jails.

—Help with employment, as soon as homeless people are stabilized in a residential setting.

—Case management to ensure that all services are available.

—Preparing people with few skills for success, once their housing situation has

been stabilized.

—Assistance, particularly with children, to avoid disruption of family life during

times of homelessness.

These services are especially urgent given the Department of Housing and Urban

Development’s emphasis on funding the housing, not the services, associated with

homeless assistance programs. 30 percent of the funds in the HUD homeless programs is reserved for permanent housing. This is a unique opportunity to build infrastructure in communities to move the most disabled and chronically homeless

people out of homelessness. But these same housing projects need services in order

to be successful.

Recommendation: Appropriate $100 million for the Grants for the Benefit of Homeless Individuals program.—This program, first authorized in 1992, has the potential

to fill the most gaping hole in the system of supports for chronically homeless people—the lack of effective substance abuse treatment services. The program would

provide competitive grants from the Substance Abuse and Mental Health Services

Administration to local agencies, to provide specific services for homeless people

with addictive disorders and/or mental illnesses. Last year the Committee appropriated $10 million for substance abuse treatment for homeless people. An expansion of this program would supplement the funds committed for housing by HUD,

and greatly increase program success.

Recommendation: Appropriate $75 million for Projects for Assistance in Transition

from Homelessness.—PATH provides formula grants to each state for outreach, case

management and treatment for homeless people with severe mental illnesses, including those with a dual diagnosis of mental illness and drug or alcohol addiction.

PATH is ideal for funding outreach and case management, allowing people with severe mental illness to be brought into the system of care, their treatment stabilized,

and services to continue once they are permanently housed.

Recommendation: Provide $172 million for Health Care for the Homeless (through

a $2 billion appropriation for Consolidated Health Centers).—Health Care for the

Homeless is part of the Consolidated Health Centers line item in the budget for the

Health Resource Services Administration. The program funds clinics that specialize

in the unique treatment challenges presented by people who are homeless, often for
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long periods of time. Clinics provide primary care, as well as diagnostic, preventive,

emergency medical, pharmaceutical, addiction, and mental health services. They

also conduct intensive outreach and case management, linking patients to housing,

income and transportation. HCH projects are ideal to provide outreach and to stabilize the worst-off homeless people.

Recommendation: Appropriate $120 million for the Runaway and Homeless Youth

Programs.—The Administration for Children and Families within HHS operates coordinated competitive grant programs addressing the problems of homeless and runaway youth. Runaway and Homeless Youth programs support cost-effective, community-based services that protect youth from the harms of life on the streets and either reunify them safely with family or find alternative placements. RHYP ends

homelessness by engaging in outreach, and quickly rehouses as many homeless

youth as possible. For others, it provides services that will prepare them to enter

adulthood housed.

BUILD THE INFRASTRUCTURE

In addition to initiatives that focus on homelessness, bringing homelessness to an

end will require larger systemic reforms to improve the incomes of the poorest

Americans, to make housing more affordable, and to make services widely available

to those who need them. This subcommittee’s efforts in areas such as child care,

education and employment are critical in this regard.

Recommendation: Appropriate $1.4 billion for the Low-Income Home Energy Assistance Program.—Inability to pay for utilities is second only to inability to pay

rent as an economic cause of homelessness. LIHEAP has for many years proven an

effective program with bipartisan support, designed to help low-income people afford

these charges and avoid homelessness. We encourage Congress to provide adequate

funding for this important program.

PREPARED STATEMENT OF THE NATIONAL ALLIANCE FOR EYE AND VISION RESEARCH

AND THE FOUNDATION FIGHTING BLINDNESS

The National Alliance for Eye and Vision Research (NAEVR) and the Foundation

Fighting Blindness are pleased to have the opportunity to submit their views to the

Subcommittee. NAEVR is a nonprofit advocacy coalition of 37 eye research organizations dedicated to expanding our national capacity to address eye and vision research opportunities. The Foundation Fighting Blindness is a non-profit research

foundation dedicated to finding treatments and cures for retinal degenerative diseases such as retinitis pigmentosa, macular degeneration and Usher syndrome.

These blinding eye diseases affect over 6 million Americans of every age and ethnicity. The Foundation Fighting Blindness supports 17 interdisciplinary research

centers and over 150 targeted grant programs around the country.

We would like to begin by thanking the Subcommittee for your continuing commitment to biomedical research supported by the National Institutes of Health

(NIH) and the National Eye Institute (NEI). Congress has been tremendously supportive of pushing the frontiers of medical research through support of the NIH. We

know that you have many difficult decisions with regard to funding priorities in

your Appropriations Bill and we appreciate the strong support that you have provided NIH. With this funding, NEI supported researchers have developed several

promising experimental treatments with the potential to halt vision loss and restore

sight for millions of Americans. We are now at a turning point. Clinical trials testing a number of new treatments are within our grasp. To advance these promising

treatments to clinical trials requires even greater financial commitment from organizations like The Foundation Fighting Blindness and the federal government. Currently, only a fraction of the research needed to make treatments and cures a reality

is funded.

FISCAL YEAR 2002 FUNDING REQUEST

We urge your continued commitment to the congressional campaign to double the

NIH budget by fiscal year 2003. We strongly support the recommendation of the Ad

Hoc Group for Biomedical Research Funding calling for a $3.4 billion, or 16.5 percent, increase for NIH in fiscal year 2002. This request represents the necessary

funding level to maintain the course towards the NIH doubling effort.

Within the context of the NIH budget, the National Alliance for Eye and Vision

Research and the Foundation Fighting Blindness request your support for a budget

of $620 million for the NEI in fiscal year 2002. This funding level represents a

$109.4 million, or 21 percent, increase above the current year budget. This level of
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funding for eye and vision research is called for as a result of previous disparities,

which have disadvantaged NEI in the NIH priority setting and funding allocation

process. Historically, the NEI ranks among the lowest Institutes relative to the percentage increase in funding provided by the Congress. A fiscal year 2002 budget of $620 million also reflects the professional judgment

of the vision research community as the funding necessary to continue ongoing research initiatives and pursue new scientific opportunities that have resulted from

the nation’s investment in eye and vision research. We would like to discuss some

of the exciting research opportunities that will be pursued with this level of investment to assure you that an investment in eye and vision research will be a wise

and cost-effective investment.

Genetics and Gene Therapy.—Ongoing genetic studies are revealing the normal

function of genes and how those functions are impaired when genes mutate which

in turn will provide essential insight into many types of vision dysfunction. Gene

therapy holds great potential as a therapeutic strategy to halt the progression of

many forms of blinding eye diseases, including macular degeneration, retinitis

pigmentosa, and glaucoma. Gene therapy has already proven to be successful in preventing vision loss and restoring sight in rodent models of retinitis pigmentosa.

Tissue and Cell Transplantation.—NEI-sponsored scientists are determining

whether transplanting healthy cells into the retina might lead to new treatments

for people with blinding eye diseases, such as diabetic retinopathy, glaucoma and

age-related macular degeneration—the leading cause of blindness in the United

States.

Drug Therapy.—A new therapeutic drug developed may be important in treating

blindness in human caused by diabetic retinopathy or macular degeneration. Vessels

that grow abnormally in the eyes can leak fluid or blood, causing rapid and severe

vision loss. This new drug, PKC 412, blocks new abnormal vessel growth and has

no apparent adverse effects on normal vessels. More tests are needed to determine

whether the drug is a viable, effective alternative in the treatment of diabetic retinopathy.

Neurodegeneration Research.—Research on neurodegeneration and the rescue and

regeneration of neural cells is an area of tremendous opportunity with application

to many neurological diseases and conditions, and to cases of traumatic injury, including:

—Rescue of Photoreceptors in Retinal Degenerative Diseases: A number of research advances now support the development of strategies for preventing or

slowing down photoreceptor degeneration in retinal degenerative diseases.

There are numerous opportunities for basic research in this area, as well as opportunities for translating these research advances to patient care. A number

of approaches show promise, including the use of growth factors, transplantation, and molecular and genetic technologies.

—Survival of Retinal Ganglion Cells: Retinal ganglion cells (RGCs) can be studied

in culture conditions, providing a special opportunity for investigating signaling

mechanisms that normally promote survival and how these mechanisms are altered by injury.

Protection of Nerve Cells in Glaucoma—Researchers have found elevated levels of

nitric oxide synthase in the optic nerve heads from human eyes with glaucoma and

animal models of glaucoma. By pharmacologically inhibiting the production of nitric

oxide in these animals, scientists found that axons of the optic nerve were protected

from neurodegeneration. NEI-supported scientists are also conducting research to

improve the understanding of the nature and course of glaucoma, incorporating

studies of co-morbidity, natural history, and genetics with special emphasis on Hispanic, Native American, and African-American populations.

Resources for Research on the Visual System.—In order to better understand the

molecular and genetic basis for diseases of the eye and disorders of vision, it is essential that research be conducted to identify and sequence genes that are expressed

in the visual system. There are a number of projects which could be pursued much

more aggressively with additional NEI funding. This genetic information will be collected from ocular tissues that are qualitatively and quantitatively representative

of the genes expressed in the visual system and optimized to detect rare or unique

sequences. It is anticipated that this catalogue of genes expressed in the visual system will be publicly available in an easily accessible and retrievable format to facilitate research on eye diseases with the goal of improving treatment or preventing

their occurrence.

Control of Angiogenesis.—Diseases that affect the retinal blood vessels are among

the major causes of visual disability and blindness in this country. These include

diabetic retinopathy, retinopathy of prematurity, neovascular glaucoma, and age-related macular degeneration in which the proliferation of abnormal new blood vessels
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can result in the rapid and irreversible loss of vision. Scientists have discovered that

inhibitors of certain growth factors and enzymes are ideal candidates for the treatment of these diseases.

Bioengineering and Advanced Instrumentation.—NEI is pursuing the development

of advanced assistive devices for the visually impaired, adaptive optics and other imaging techniques to improve non-invasive examination of ocular tissues for both research and disease diagnosis, instruments to analyze the biomechanics of the eye,

and instruments to analyze visual performance. NEI is continuing research on the

further development of laser-targeted dye delivery systems which could revolutionize the visualization of blood vessels in the retina and the treatment of eye disorders; and optical coherence tomography and confocal scanning laser polarimetry

for quantitative measurements of the retinal nerve fiber layer.

Clinical Research and Health Disparities.—Research in this area will enhance our

understanding of glaucoma, diabetic retinopathy, and myopia incorporating studies

of comorbidity, natural history, and genetics with special emphasis on populations

at increased risk. For example, rates of blindness from glaucoma are six times higher in African-Americans than in Caucasians, however age-related macular degeneration is rare for African-Americans as compared to Caucasians.

Low Vision.—A related area of concern is low vision, or vision impairment which

is not correctable by glasses or contact lenses. As many as 12 million Americans suffer from visual impairments which affect their ability to read, drive, work, and perform many everyday activities we all take for granted. The most common eye diseases which cause visual impairment in adults are AMD, cataract, glaucoma, diabetic retinopathy, and optic nerve atrophy. Even more serious are the eye diseases

which cause visual impairment in children. These include retinopathy of prematurity, cortical visual impairment, and coloboma. Low vision in children often affects their development and results in the need for special education, vocational

training, and social services throughout their lives. The cost of these impairments

is more than $22 billion each year.

Under the auspices of the National Eye Health Education Program (NEHEP), NEI

has developed and is initiating a program directed at low vision in order to increase

public awareness about visual impairment and the impact it has on everyday life.

The Low Vision Traveling Exhibit will be displayed in shopping malls around the

country during the next five years and was recently launched in Birmingham. Alabama. The program provides information about low vision services and the devices

which are currently available to assist those with visual impairments. This effort

is directed at those suffering from visual impairments and also to medical professionals, eye care specialists, managed care organizations, and family members.

NAEVR supports this public education partnership and urges the Committee to support it as well.

By the year 2030, the NEI estimates that the elderly population in the United

States will double and more than 66 million Americans will be at risk for blinding

eye diseases. If we do not make significant investments in vision research, we will

have both an economic and health care crisis in this country, given our nation’s demographics. With increased support for the NEI, we can make treatments for many

vision diseases and disorders happen within our lifetime.

Conclusion.—Mr. Chairman, the members of the National Alliance for Eye and Vision Research and the Foundation Fighting Blindness are supportive of an increased

research focus on eye and vision disorders that improves the quality of life for all

Americans by allowing individuals to remain independent and lead productive, fulfilling lives. We urge the Subcommittee to provide a total NEI budget of $620 million, or a 21 percent increase in fiscal year 2002. In this new millennium we must

ensure that we are doing our best to find ways to prevent and treat eye and vision

disorders, and are providing quality eye care services and devices for those who are

already suffering from visual impairment.

Thank you for allowing the National Alliance for Eye and Vision Research and

the Foundation Fighting Blindness to present their views.

PREPARED STATEMENT OF THE NATIONAL ALOPECIA AREATA FOUNDATION

Chairman Specter and Members of the Senate Appropriations Subcommittee on

Labor, Health and Human Services, Education and Related Agencies, I am Vicki

Kalabokes, Chief Executive Officer of the National Alopecia Areata Foundation

(NAAF) for the past fourteen years. Before I begin my testimony, I would first like

to express to you my deep gratitude for the Congress’ on-going bipartisan support

of research at the National Institutes of Health (NIH), and most particularly for

their recent support of increased funding, via passage of the Children’s Public
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Health Act of 2000, for autoimmune disease research-research that might not otherwise have been funded.

As a non-profit voluntary health agency, the National Alopecia Areata Foundation

is the largest organization in the nation dedicated to supporting research and finding a cure or acceptable treatment for alopecia areata, a common but mysterious

and unpredictable autoimmune skin disease resulting in hair loss. The Foundation

also provides emotional support for those with the disease through a publication

program, an annual conference, and support groups. The support groups provide information and direction to thousands of people with alopecia areata. As a lay organization and the nationwide center for those affected by alopecia areata, the Foundation is often the first place, outside of the medical community, that a person turns

to for help and information. Frequently people call who are scared, misinformed,

and afraid. The support groups provide a forum to reach out to others, solve common problems and grow.

The National Alopecia Areata Foundation receives no federal grants or subgrants,

nor do we receive federal contracts or subcontracts. The Foundation is also a member of, and the past headquarters for, the Coalition of Patient Advocates for Skin

Disease Research (CPA–SDR). The Coalition, which operates as a voluntary organization and as such receives no public or private money, provides an umbrella to over

25 ‘‘lay’’ skin groups. These groups represent millions of people who suffer from a

wide range of skin diseases. We work together for two reasons. First, to provide information to others about why research is needed. And secondly, so that we may

push for a wide ranging research agenda. Recent research has demonstrated that

diseases such as alopecia areata, lupus, vitiligo and others are the result of a malfunctioning immune system. When the key is found to one of our diseases, then it

is very likely that many of the other diseases represented in the Coalition will be

cured. By working together we can and will make a difference.

Alopecia areata is an autoimmune skin disease that strikes over 4.5 million Americans. It results in the loss of hair. For the fortunate few it is a quarter-size patch

that can be easily covered, for many others it is the loss of every hair follicle on

their entire body. For over half of the people with alopecia areata, it starts between

the ages of 5 and 9. It strikes members of all ages and ethnic groups; males and

females are equally affected. The loss of hair has several types of impacts. Hair provides significant protection for the body. The loss of eyelashes or nasal hairs means

that even the simple acts of opening and closing one’s eyes, or breathing in or out,

cannot keep dust or foreign particles away. These natural physical acts become a

very difficult process.

However, alopecia is not simply a physical problem, it has surprisingly serious

psychological consequences. For many people, when they first discover their hair

falling out they are devastated. They think that they are the only ones in the world

with the disease. Frequently when they go to their doctors they discover that even

their physicians have little idea of what is happening, why it is happening, or even

if others suffer from it. For some, treatment options stop at that point, while for

others, they begin the long process of finding someone who knows something about

the condition.

Unfortunately in our society the lack of information is not the only problem. Frequently people with alopecia arata believe that they are vulnerable to the stares and

grimaces of those around them. People have lost their jobs. A noted news anchor

lost his on-air job because he was suddenly perceived as being unappealing. This

lack of being appealing (either real or perceived) causes many people to lose confidence in themselves and they begin to withdraw from society.

Recently, the Foundation received a call from a young woman who was denied the

ability to take her GRE (Graduate Record Examination) simply because she arrived

to take the test wearing a head covering. She was sternly reprimanded and, without

prior notification, was informed that absolutely no hats or head coverings were allowed to be worn while taking the exam. Her choice was either to remove her scarf

and suddenly expose her completely bald scalp, or to leave the room immediately

and forfeit taking the test. And in Washington D.C., a young child was deprived of

taking a school field trip simply because others feared his hair loss was contagious.

In the recent past, two parents called about their children. These two girls, one 12

and the other 14 at the time, were in the process of losing their hair. They stayed

inside their homes, fearing that going outside would lead to harassment, cruel

stares, and not-being accepted as normal. Sadly in this image-conscious society, this

is so often the case. It seems to be hardest on the children, who are routinely teased

and even shunted into special education classes.

Fortunately, there are people who can help, and in many of our support groups

people learn how they can help themselves both cosmetically and psychologically.

They learn that they are not alone and that they can do something about their
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sense of vulnerability and isolation. But the real solution will be when we find a

cure for alopecia areata. Over the past fifteen years the Foundation has raised and provided nearly $2.5

million for research studies. Our privately funded research grants have been studying the mechanisms of hair biology; the genetics and functioning of the immune system; the etiology, genetics, clinical presentation and therapies of alopecia areata,

and the development of non-human research studies looking for the cause of and

treatments for alopecia areata. One of NAAF’s recent grant awards resulted in the

scientific demonstration that alopecia areata is indeed an autoimmune disease. In

addition, an association exists between alopecia areata and numerous other autoimmune diseases such as vitiligo, thyroiditis, Addison’s Disease, Type I diabetes,

and others. Obviously the potential benefit from cross-over research is enormous.

Part of our research program is to continue to work with the National Institute

of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) to create a research

agenda. In September 2000, NIAMS announced the awarding of a disease registry

on alopecia areata, a watershed event in the history of alopecia areata research.

This award of more than $2.7 Million over five years will establish a research registry consisting of five sites across the United States. This commitment by NIAMS

to the advancement of alopecia areata research creates an enormous opportunity to

further basic, clinical, and translational studies in alopecia areata. It will provide

an essential resource for all investigators interested in studying alopecia areata and

will stimulate opportunities for additional research support from federal and private

sources. The monies from this grant will not go to NAAF, but directly to the institutions of the investigators overseeing the research at these five centers.

In 1990, 1994, and 1998, NIAMS and NAAF conducted three international research workshops on what is known about alopecia areata. One of the many results

from these joint programs was that NIAMS funded a significant study on the structure of the disease. Another result was the discovery of animals with alopecia-thus

NAAF was able to support the first non-human host of the disease. Recent genetic

studies have revealed unique markers (HLA or histocompatibility leukocyte antigens) on the surface of white blood cells in those with alopecia areata, strongly suggesting the existence of both susceptibility as well as severity genes. These findings

are very similar to what has been noted in HLA marker groups of those with other

autoimmune diseases.

We are now planning the Fourth International Research Workshop on Alopecia

Areata in 2002 in conjunction with NIAMS. This symposium, as with the earlier

meetings, will bring researchers, clinicians, and patients together from around the

world to study what progress has been made and how new studies should be structured. The convening authority of NIAMS is critical for this sharing of knowledge.

Working together in this unique private-public partnership is a significant step

towards finding a cure. We hope to continue this relationship with NIAMS providing

limited funds for critical studies, while we continue to work to support the research

effort as well. With this partnership we have been able to sharpen the research

agenda so that we are looking at questions that are building on a wider and more

informed base of knowledge.

The National Alopecia Areata Foundation asks that you continue to support

NIAMS by increasing the overall budget of the National Institutes of Health (NIH).

The NAAF believes that we must sustain the current level of increased commitment

to the NIH. The NAAF joins the Ad Hoc Group for Medical Research Funding, the

NIAMS Coalition, and the Coalition of Patient Advocates for Skin Disease Research

in asking Congress to support a 16.5 percent ($3.4 Billion) increase in the budget

of the NIH for fiscal year 2002. This increase would allow us to get back on track

to continue the bipartisan effort to double the NIH budget by fiscal year 2003—a

sentiment shared by the President, the Congress and the American people.

Funding biomedical research through the NIH is today’s investment in America’s

future. The economic burden in the United States for musculoskeletal and skin diseases is staggering. The annual cost for medical care and lost wages resulting from

skin diseases alone is estimated to be $22.3 Billion, affecting over 65 million Americans. The research for these diseases falls under the umbrella of NIAMS and today’s

technology, like never before, has enabled us to understand, treat and ultimately

cure many of these devastating, chronic skin diseases. Support for the NIH, and

therefore NIAMS, is particularly instrumental in unlocking the genetic mysteries of

autoimmune skin diseases such as alopecia areata.

Again, we are asking for an increase of 16.5 percent or $3.4 Billion. This increase

would allow NIAMS to increase its ability to continue to fund more research projects

and support more programs that will help these 65 million Americans who are impacted by skin diseases. We also believe that work done in any of the disease areas

represented by the Coalition of Patient Advocates for Skin Disease Research, will
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have a profound impact on the lives of the millions of those who suffer from one

or more of the diseases that NIAMS is charged with investigating. We also believe

that when a cure is found for any of these diseases that there is a good chance that

it will help in finding a cure for many of the other skin diseases.

Again, thank you for your past support of medical research funding. Thank you

so very much for your time and concern.

PREPARED STATEMENT OF THE NATIONAL ASSOCIATION OF ANOREXIA NERVOSA AND

ASSOCIATED DISORDERS

When a young woman starves to death in the midst of plenty; when a young

woman despairs of hope in trying to cope with a deadly illness at age 32 after struggling to survive for 17 years; and when thousands of people all across America

strive to live, but are victims of insurance discrimination, assistance and guidance

are desperately needed. All of these are recent documented cases of eating disorders.

eating disorders is the major illness in our nation which receives totally inadequate

support or funding.

Eating disorders are rampant in our society and have reached epidemic levels. All

segments of society, young and old, rich and poor, both sexes and all races are impacted by eating disorders. These illnesses, which include anorexia nervosa, bulimia

and binge eating disorders, ravage the lives of more than 8 million people in the

United States including seven million women and young girls. An estimated 6 percent of the individuals with severe eating disorders will die; a higher mortality rate

than for any other mental illness. For those who remain ill the constant thoughts

of food, weight, body and behaviors distort body image and their thought processes

to the degree that their lives are centered in a kind of hell rather than in living.

Although eating disorders are so prevalent in society, neither the federal government nor most states in the nation have adequate programs or services to combat

anorexia nervosa, bulimia or binge eating. There are few programs to prevent or

educate children and youths about eating disorders in schools and colleges. Resources that public health agencies and schools devote to the prevention of eating

disorders are negligible in comparison to the resources and attention that they give

to the prevention of other serious health problems such as drug and alcohol abuse.

At all levels, federal, state and local, a significant commitment must be made to the

prevention of these life-destroying illnesses.

Children and adolescents are a critical target of these prevention programs as

eighty-six percent of individuals with eating disorders report the age of onset by 20

years. Of these 43 percent were between 16–20 years; 33 percent between 11–15

years; 10 percent 10 years and younger. Shockingly eating disorders have been

found in children as young as 5 years of age. Something must be done to save these

children.

We request that a minimum of $10,000,000 be appropriated for the development

and implementation of comprehensive education and prevention programs that promote healthy notions about emotional development of self, nutrition, body development and growth through educational wellness for all of America’s school-aged children and early identification of those at risk for eating disorders. The need for the

request is substantial as ANAD estimates that twelve percent of high school students and ten to twenty percent of college students suffer from an eating disorder.

Founded in Illinois in 1976, ANAD is the first national health organization of its

kind. Dedicated to education, awareness, prevention and alleviating the effects of

eating disorders, ANAD helps victims and their families by providing hotline counseling, support groups, referrals to health care professionals, information packets

and newsletters, along with education/prevention programs. The services are offered

free of charge and the programs developed are low cost. ANAD also undertakes and

encourages research, fights insurance discrimination and dangerous advertising,

and organizes advocacy campaigns to protect potential victims of eating disorders.

Prevention and education about eating disorders are pivotal to ANAD’s mission.

Each year our outreach programs touch the lives of tens of thousands of people.

The causes of eating disorders are varied and have not been thoroughly delineated, however issues of identity and self-esteem and other psychological problems

often underlie eating disorders. Societal and cultural influences emphasize thinness

and work simultaneously with media and advertising campaigns to continually reinforce the message to be thin. Unrealistic self-images often result. Individuals feel

vulnerable and powerless in relationship to the world at large and eating disorders

provide the illusion of being in charge of one aspect of their lives, food.

Education and prevention programs which teach children the skills needed to cope

with the emotional complexities of life in a positive and life and self affirming way
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are crucial. ANAD’s theme of ‘‘Accept Yourself, Accept Others’’ encourages people to

make healthy choices, build self-esteem and lead to healthier living practices. Teaching proper nutrition alone is not enough as evidenced by a statement a dietitian

with an eating disorder once made. ‘‘Through my training, I can teach anyone the

right diet for any condition . . . as to myself none of that applies to me.’’

Prevention programs and support services need not be expensive to be effective

as proven by ANAD’s many successful programs and services. Implementation of

these programs will ultimately lead to an enormous financial savings as it will reduce the number of victims who will need expensive and lengthy medical and psychiatric care required to treat serious eating disorders. In monetary terms the cost

savings will be enormous and in human costs, the savings will be immeasurable.

We also request the Senate to increase current funding by an additional $10,000,000 for research into the causes and treatment of eating disorders, and research evaluating the effectiveness of different prevention, treatment and self-help

support strategies. By elucidating the causes of eating disorders the specific at-risk

population can be identified and helped prior to the life-destroying effects of the illnesses taking hold on their lives. Deciphering the role of genetics in determining

who is at-risk for these disorders would also be valuable in prevention and treatment of eating disorders. This funding is essential to the development of truly effective prevention programs and treatment strategies.

Furthermore, improving patients’ access to quality, affordable treatment through

insurance reform and parity bills is vital. High quality treatment is available, however many victims of eating disorders are unable to access this treatment due to

restrictions placed on them by insurance companies. Concurrent medical and psychological services are often necessary when treating people suffering from eating

disorders. Often, because eating disorders are treated solely as a mental illness, patients are both denied the medical treatment that they require and are subjected

to the extremely low caps on benefits for treatment of mental illness.

Action must be taken to change the uphill battle that victims of eating disorders

face when confronting insurance needs. On the legislative front, proposals for insurance reform and health care reform must ensure that patients with eating disorders

can receive reimbursement for both medical and mental health care. Government

funded mental health centers should be encouraged to develop multidisciplinary approaches to the treatment of eating disorders.

We ask the Senate to help safeguard the rights of people with eating disorders

through reforms of the health care and insurance systems. We also ask the members of this subcommittee and the Senate to enact legislation that provides funding

aimed at preventing another generation of youth from developing eating disorders.

This legislation would also fund research into the causes of eating disorders which

would in turn strengthen the effectiveness of eating disorder treatment protocols.

Thank you.

PREPARED STATEMENT OF THE NATIONAL ASSOCIATION OF CHILDREN’S HOSPITALS

Mr. Chairman and Members of the Subcommittee, my name is Dr. Robert Felter,

and I am the Chairman of Pediatrics and Medical Director at Tod Children’s Hospital in Youngstown, Ohio.

I submit this testimony on behalf of the National Association of Children’s Hospitals in Alexandria, VA, in support of the Children’s Hospitals’ Graduate Medical

Education (GME) program in the Health Resources and Services Administration. On

behalf of the nation’s nearly 60 independent children’s teaching hospitals, I urge you

to continue to provide adequate funding for Children’s Hospitals’ GME so that these

institutions will have the resources to continue to train and educate the nation’s pediatric workforce.

BACKGROUND

The National Association of Children’s Hospitals or ‘‘N.A.C.H.’’ is a not-for-profit

trade association, representing more than 100 children’s hospitals across the country. Its members include independent acute care children’s hospitals such as Tod

Children’s Hospital, as well as children’s hospitals in Akron, Cincinnati, Cleveland,

Columbus and Dayton; acute care children’s hospitals organized within larger medical centers, such as Kosair Children’s Hospital in Louisville, KY; and children’s specialty and rehabilitation hospitals, such as the Hospital for Sick Children in Washington, DC.

N.A.C.H. seeks to serve its member hospitals’ ability to fulfill their four-fold missions of clinical care, education, research, and advocacy devoted to the health and

well-being of children. Children’s hospitals are regional and national centers of ex-
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cellence for children with serious and complex conditions. They are centers of biomedical and health services research for children, and they serve as the major training grounds for future pediatric researchers, as well as a significant number of our

children’s doctors. These institutions are advocates for the public health of children,

and they are essential to the health care safety net for children of low-income families.

While they account for less than 1 percent of all hospitals, the independent children’s hospitals train nearly 30 percent of all pediatricians and nearly half of all

pediatric specialists, and they are the major producers of future pediatric researchers.

Independent children’s teaching hospitals are experiencing very serious financial

challenges that affect their ability to sustain their missions. In addition to the challenges of covering the costs of their academic programs, they include challenges in

covering the higher costs of sicker patients in a price competitive marketplace,

meeting the costs of uncovered services such as child protection services and poison

control centers, and assuming the costs of devoting a large portion of their patient

care to children from low-income families.

On average, independent acute care children’s hospitals devote nearly half of their

patient care to children who are assisted by Medicaid or are uninsured. They devote

more than 75 percent of their care for children with one or more chronic or congenital conditions. For children with rare and complex conditions, independent children’s hospitals often provide the majority of care in their region or even nationwide.

Left unresolved, children’s hospitals’ financial challenges will seriously affect not

only their academic programs of education and research but also their clinical care

missions as safety net providers and centers of excellence. In fact, their roles as

safety net providers and centers of excellence are made possible in part by their

having strong academic programs.

ISSUE OF CONCERN

The issue of concern to NACH, which brings me here today, is that independent

children’s hospitals have faced serious financial burdens and competitive disadvantages in recent years, because they receive virtually no GME support through Medicare—the only source of significant and stable GME support available to teaching

hospitals. Because children’s hospitals do not care for the elderly, they have few (if

any) Medicare patients and thus receive less than 0.5 percent or 1/200th of the federal Medicare GME support provided to other teaching hospitals.

In recent years, while the Medicare program was spending about $7 billion annually on GME programs at over 1,000 teaching hospitals across the nation, children’s

hospitals received less than $2 million in federal support for their continuing education programs. The Lewin Group, an independent health policy analysis firm, calculated in 1998 that independent children’s teaching hospitals should receive approximately $285 million in federal GME support for nearly 60 institutions to

achieve parity with the financial compensation provided through Medicare for GME

support to other teaching hospitals.

In the absence of any movement towards broader GME financing reform, Congress enacted the Children’s Hospitals’ GME discretionary grant program to address

the existing inequity and ensure that these institutions could receive equitable federal support to sustain their teaching programs. The pediatric community, including

the American Academy of Pediatrics, Association of Medical School Pediatric Department Chairs, and others, recognize the critical importance of the GME programs

of the independent children’s teaching hospitals, not only to the future of the individuals hospitals and their essential services but also to the future of the nation’s

pediatric workforce and pediatric research overall.

In fact, after three years of work assessing the needs of pediatric education in the

next decades, the leadership of the pediatric education community last year issued

34 recommendations, including a recommendation for equitable GME support for

independent children’s teaching hospitals. The Future of Pediatric II (FOPE II) Task

Force said: ‘‘Pediatric residents and fellows at freestanding children’s hospitals

should receive the same level of federal support as those trained elsewhere.’’

CONGRESSIONAL RESPONSE

The 106th Congress recognized the pressing need to provide independent children’s teaching hospitals with the same federal support for their teaching programs

that they provide to all other teaching hospitals through Medicare by taking action

on two fronts:
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First, Congress has both authorized and reauthorized the program. In November

1999, with broad bipartisan support, Congress authorized $285 million for the Children’s Hospitals’ GME Program in fiscal year 2001 as part of the ‘‘Healthcare Research and Quality Act of 1999.’’ In September 2000, Congress reauthorized the program through fiscal year 2005 at ‘‘such sums as necessary’’ as part of the ‘‘Children’s Health Act of 2000.’’ Congress passed both the authorization and reauthorization bills by unanimous consent.

Second, and more importantly, Congress appropriated $235 million for Children’s

Hospitals’ GME in the Fiscal 2001 Labor/HHS/Education Appropriations bill as a

specific line-item within the Health Resources and Services Administration (HRSA)

account. Last year’s funding was a significant increase over the fiscal year 2000

funding of $40 million—an initial funding level provided for the program before it

was authorized.

The $40 million appropriated in Fiscal 2000 was distributed through HRSA to 57

children’s hospitals according to a formula based on the number and type of fulltime equivalent (FTE) residents trained, as well as the complexity of care and intensity of teaching the hospitals provide. HRSA will soon be finalizing the process of

distributing $235 million in Fiscal 2001 funding to children’s hospitals to cover a

higher percentage of the costs associated with their GME programs.

IMPACT ON TOD CHILDREN’S HOSPITAL

Tod Children’s Hospital, which is part of Forum Health, is a 97 bed-facility that

serves as a regional referral center, delivering care to children in northeastern Ohio

and western Pennsylvania, with more than 30 subspecialties and a number of specialized programs, such as a children’s emergency center and a pediatric inpatient

cancer unit. We serve all children, devoting more than 60 percent of our care to children who are assisted by Medicaid or uninsured.

Tod Children’s Hospital also is a teaching hospital, training 27 resident FTEs, including 24 in pediatrics and three in medicine and pediatrics. Despite the small size

of our training program, it has an enormous impact on the availability and quality

of health care for children in the Youngstown area. The majority of our residents

go on to practice in Ohio, and in the last six years, more than 40 percent went on

to practice in Youngstown. Today, 50 percent of pediatricians practicing in Youngstown were trained at our hospital.

Youngstown is an economically depressed community, which makes it hard to attract strong, clinical talent to come to and stay in our area. Without our training

program, the pediatric workforce of Youngstown would be seriously affected. And

without our training program, our ability to maintain a children’s hospital and its

substantial contribution to the quality of care for all of the children of our region

would also be seriously challenged.

Clinical care and residency training go hand in hand. A strong training program

contributes to a strong clinical program, and a strong clinical program contributes

to a strong training program. Our hospital spends more than $2 million to cover the

direct costs of our GME program, which represents a major expense for our institution. As a consequence, every year our hospital faces difficult financial tradeoffs as

we struggle to balance our commitments to training and clinical care. Even with the

GME funding our hospital received as a result of the fiscal year 2000 appropriation,

Tod Children’s could not sustain is residency training program without cutting our

family-based HIV clinic serving infected children and their mothers and scaling

back our child-life program. These kinds of financial decisions are not easy to make.

However, with equitable GME support from the federal government—comparable to

what other teaching hospitals receive—our hospitals will be able to cover the added

costs that result from their teaching missions while being able to provide other important programs and services that affect the health and well being of the children

of our region.

The significant increase in funding we project to receive from the fiscal year 2001

appropriation is absolutely vital to our residency training program, our hospital, and

our community. Without it, the future of our training program will be in jeopardy,

and that in turn will put in jeopardy the long-term future of our children’s hospital

and the health of the children of our community.

With such a major impact on a small institution like Tod Children’s and our community, you can imagine the magnitude of the impact that Children’s Hospitals’

GME funding will have on much larger institutions and their regions—Children’s

Hospital Boston with 238 resident FTEs, Children’s Hospital of Michigan with 160

resident FTEs in Detroit, or Children’s Hospital Medical Center in Cincinnati with

153 resident FTEs.
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FISCAL 2002 NEED

I am here to impress upon you that adequate funding for Children’s Hospitals’

GME is an ongoing need. Our institutions continue to train new pediatric residents

and researchers every year. While we have appreciated very much the Congressional support—particularly with the funding provided in Fiscal 2001—we have received, the teaching mission carried out by children’s hospitals will not end this

year. Now, we seek to achieve full parity with other teaching hospitals for federal

GME support, which will require the full authorization of $285 million for Fiscal

2002.

In order to make children’s health a top priority for our country, Congress should

appropriate the fully authorized funding level of $285 million for Children’s Hospitals’ GME in Fiscal 2002. These funds will ensure that independent children’s hospitals receive the resources necessary to continue to train and educate the nation’s

pediatric workforce and sustain their core missions, including clinical care and research.

Support for a strong investment in GME at independent children’s teaching hospitals is consistent with the repeated concern the Subcommittee has expressed for

the health and well being of our nation’s children—through education, health, and

social welfare programs. It also is consistent with the Subcommittee’s repeated emphasis on the importance of enhanced investment in the National Institutes of

Health (NIH) overall, and in NIH support for pediatric research in particular, for

which we are very grateful.

Finally, support for this program is a strong investment in cost effective health

care. Please remember that prevention is the core of pediatrics. We train every pediatrician to specialize first in primary and preventive health care, which maximizes

children’s long-term health and reduces the long-term cost of their care, not only

as children but also as adults. As a result, it’s an investment in the future health

of everyone. The children we care for today may be only 25 percent of our population; but tomorrow, they will be 100 percent of all adults.

PREPARED STATEMENT OF THE NATIONAL ASSOCIATION OF DEVELOPMENTAL

DISABILITIES COUNCILS

The National Association of Developmental Disabilities Councils is a national organization representing Developmental Disabilities Councils in thirty-nine states

and territories. Combined with the Councils represented by the Consortium of Developmental Disabilities Councils, there are a total of 55 Councils—one in each

State, the District of Columbia, and the territories of American Samoa, the Commonwealth of the Northern Marianas Islands, Guam and Puerto Rico. NADDC provides leadership to member Councils to support their work for change on behalf of

individuals with developmental disabilities and their families. On the national level

we support policies that enhance the quality of life for all people with developmental

disabilities—individuals who experience a severe, chronic disability which occurs before the age of 22 and results in substantial functional limitation in three or more

areas of major life activity (self-care; receptive and expressive language; learning;

mobility; self-direction; capacity for independent living; and economic self-sufficiency).

Council activities are authorized through the Developmental Disabilities Assistance and Bill of Rights Act (Public Law 106–402). The ‘‘DD Act’’ was originally enacted in 1963 as the Mental Retardation Facilities and Construction Act in response

to the need for alternatives to large institutions. It has been expanded to meet the

growing needs for community supports with each subsequent reauthorization. In addition to the State Councils on Developmental Disabilities (Part B of the Act), the

Act also provides authority for funding in each State and territory for a statewide

Protection and Advocacy System and a University Center for Excellence in Developmental Disabilities Education, Research and Service (formerly the University Affiliated Programs).

The Governor in each State and territory appoints members of State Councils.

Sixty percent of the Council membership must be people with significant disabilities

and their family members. The rest are state agency administrators, private providers, and members of the community. Together this group develops and implements a statewide plan which lays out activities to enhance the lives of people with

developmental disabilities through a variety of systemic change, capacity building

and advocacy activities. The Councils’ plans promote a comprehensive system of

services and supports designed to increase the independence, productivity, inclusion,

integration and self-determination of individuals with developmental disabilities.
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Federal funding for these activities is administered by an agency also designated

by the Governor.

Flexible systems based on individual empowerment and self-determination that

require partnerships between the professional and the consumers have proven to be

the key ingredients for the successful promotion of the goals expressed in the DD

Act. Unfortunately, systems change is difficult and state systems for developmental

disabilities were designed years ago to ‘‘treat’’ rather than partner with the individual receiving the service. The Councils have a key role to play in bringing

changes about in ways that can positively impact individuals with developmental

disabilities.

To assist States, the Act lists a number of ‘‘areas of emphasis’’ for Council activities. Councils can choose to work on issues related to quality assurance, childcare,

housing, transportation, recreation, education, employment, health, and formal and

informal community supports. They are required to strengthen, support and expand

opportunities for individuals with developmental disabilities to receive and provide

leadership training and to work in coalitions. They are also free to establish priorities outside of those prescribed in the Act to meet the unique needs of individuals

with developmental disabilities in their own State or territory.

While Councils are not service providers, one of the ways that we are able to advance change is through direct support of best practice activities. One of the more

recognized activities of the State Councils are grants to public and private agencies

that support system change projects, demonstrating at the local level that there is

a better way to provide services to individuals with disabilities. Because there are

too few quality community services for people with developmental disabilities, the

Councils have taken on the responsibility of assisting grantees seek new State, local,

and private sector funds to support these activities. Preliminary data for fiscal year

2000 indicates that in this way Councils helped leverage far more in state, local and

private funds for services and supports than the taxpayer invested in the four DD

programs combined at the Federal level.

DD Council work goes far beyond service system improvement into new areas of

community development that improve the lives of everyone—including people who

do not have disabilities. Realizing that people are best protected and included in

their communities if their lives are intertwined with families, neighbors, friends and

co-workers, DD Councils also work on community and economic development so that

all citizens share in the resources communities have to offer. It is clear that if we

want people with disabilities to have competitive jobs and life-long careers, we must

invest in the economic vitality of our communities: poverty-stricken communities result in poverty for people with disabilities. If we want people with disabilities to live

safe and healthy lives, we must invest in affordable housing initiatives for them and

their neighbors: slums and homelessness are bad for everyone. If we want children

with disabilities to attend school with their non-disabled peers and become productive, civic-minded adults, there must be quality education for all children. If we

want people with disabilities to be included in our communities, we must have communities that appreciate and believe in the equality of all people.

For all of these reasons, Councils are viewed as invaluable change agents in the

States and have made a significant difference in the lives of individuals and their

families across the nation. Best practices promoted by Councils have resulted in,

among other accomplishments, strong early childhood programs; improvements in

school services; access to real, inclusive jobs through supported employment; small

business ownership; training and empowerment of self-advocates; means to address

the crisis in the shortage of qualified direct care professionals; home ownership; accessible transportation systems; appropriate community activities for individuals

with developmental disabilities as they become older; and tremendously important

supports for families so they can remain healthy and intact. In keeping with changing times, Councils across the country are now called on to address burgeoning community waiting lists; to plan for the huge demands that will be placed on services

by the aging baby boom generation—including the loss of a large percentage of the

service provider population as they reach retirement; and to face the challenges of

abuse and neglect in a wide range of settings.

A sampling of activities across the country should be helpful in understanding the

importance of the Developmental Disabilities Councils in each State. To give the big

picture would take volumes, but the following provides a glimpse into some of the

State Councils list of achievements.

—The DD Council in Ohio developed a self-determination initiative that has proven so successful that it has been adopted by the State Department and has

spread to 30 out of the 88 counties. This effort continues to grow through the

State, resulting in more control for individuals with developmental disabilities

over their own lives.
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—Through a grant with Very Special Arts of Idaho (VSAI) the Idaho Council is

assessing the accessibility of arts, leisure, and recreational facilities and programs across the state.

—In Iowa the DD Council working in coalition with other like-valued groups was

successful securing all of the state’s Tobacco Settlement Fund ($55 million) for

purposes related to health care and the needs of children, adults and families,

with a strong focus on special needs.

—One hundred and sixty individuals with developmental disabilities in Mississippi became employed in their communities as a result of the DD Council’s

activities in that state. One hundred and fifty eight businesses employment people with developmental disabilities, and 630 people were trained in the Person

Centered Planning process.

—Housing shortage issues are tackled head-on by a number of Councils. One initiative in New York uses a low income housing tax credit designed to encourage

private sector investment in the production of low-income housing. The program

allows the owner/developer of a qualified property a dollar-for-dollar credit

claimed over an extended period of time to equal an established share of the

property’s construction costs.

—The Maryland Council has led a statewide, cross-disability initiative to expand

homeownership opportunities to low-income people with significant disabilities.

This work has resulted in the state’s commitment of $8.2 million in mortgage

funds. The program received a HUD ‘‘Best Practice’’ award in 1999.

—In North Dakota public transit services, when available, are not fully accessible.

Thanks to start-up funding provided by the DD Council, the cities of Mandan

and Bismarck have been able to address transportation needs for people with

disabilities in these cities by combining formerly fragmented and autonomous

transit programs into a consolidated, accessible community-wide public transportation system. Without access to this system riders with disabilities would

not be able to realize employment ambitions, shop for necessities, achieve independence or experience general community involvement and participation.

—The South Carolina DD Council is active in developing and monitoring a universal newborn hearing screening program required on all newborns in the

State. The program is designed to detect hearing impairments in infants. With

early detection and intervention children are more likely to experience normal

language development.

—The Community Self-Employment Program in Arkansas resulted in a number

of new entrepreneurs in the state—business owners who experience a disability.

The project was designed to provide loans to assist and support individuals in

ownership and operation of their own business. Businesses included include

Web-site designing, a concession business, a recycle shop for computers and

business machines, legal abstracting, Web marketing, and a pizza store.

—The DD Council has a long history of leading systems change efforts in Hawaii.

Among its accomplishments are the closure of Waimano Training School and

Hospital, the state institution for people with mental retardation, and the successful integration of those residents into the community. The Council also

played a key role in the development of state legislation that created the nation’s first statute codifying self-determination for persons with developmental

disabilities (Act 133, 1998).

—With an initial start-up grant in 1996 of $124,000.00 for the Home of Your Own

Program, the Nevada DD Council has leveraged more than $3 million in nonHOYO funding to provide first time home ownership to 51 Nevadans with disabilities. Through a partnership with Accessible Space, Inc. and the Office of

Community Based Services, the Council with initial funding of $250,000.00 has

leveraged over $24 million in HUD funding to build 4 affordable, accessible assisted living apartment buildings for Nevadans with severe disabilities and has

HUD funding approved to build 2 more such apartments.

—The New Hampshire Council has done significant work in voter access, giving

rise to national attention to voter access issues through work with state and national election officials. The Council published and widely disseminated a voter

manual. The Council in New Hampshire has also taken the lead in work incentives activities in their state. They have facilitated a statewide effort to coordinate the integration of three federal grants to implement the Workforce Investment Act and other employment initiatives with the Governor’s Task Force on

Employment and Economic Opportunities.

Every Council has to set priorities identified at the State level and hard choices

have to be made. Unfortunately, there are many more critically needed infrastructure activities than DD Councils alone can generate funds to address. In our public
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testimony last year we listed some of these needs. Regrettably, they have not

changed.

—Direct Care Staff—The need for additional direct care staff continues to be at

a crisis level in most of our communities. We cannot train front line personnel

rapidly enough. We know that properly trained staff on the day-to-day firing

line can spot abuse and neglect and take immediate action to stop such incidents and prevent any repetition. High turnover rates and poor compensation

are significant challenges to our services system. If these issues are not addressed, we will see individuals with developmental disabilities lose their newfound independence.

—Inclusive Child Care—There is a well-documented shortage of quality childcare

for working parents. This is an even more serious problem for parents of children with disabilities who do not want their children segregated from their nondisabled peers—for parents who want their children in childcare settings that

welcome all children.

—Transportation System Redesign—One of the major blockades for individuals

with disabilities who wish to work but who require special transportation accommodations is the lack of such accommodations. The lack of affordable, accessible transportation is often identified as the single most constant problem faced

by individuals with developmental disabilities in achieving employment and

community life.

These are examples of some of the issues that remain largely untouched by Council advocacy due to the lack of funding. This list will grow as the Councils take on

the new activities Congress included for the DD Councils in the Act last year. The

law now includes a role for the Councils in addressing issues of: (1) aging parents

of adult sons and daughters with developmental disabilities; (2) waiting lists; (3)

abuse and neglect; (4) inappropriate restraints; (5) development of person-centered

quality assurance systems; and (6) increased emphasis on self-advocacy.

There are high expectations of Councils in every State, and DD Councils have

demonstrated that they get results and are a bargain for the federal tax dollar. DD

Councils are taking a significant next step to build communities that work for everyone, including people with developmental disabilities, in addition to their work to

improve the service system. Because they do not provide services and can act independently of the service system, the voice of the DD Council has proven to be critical in each State and territory to the lives of people with developmental disabilities

and their families.

Unfortunately, the current reach of the State Councils is far smaller than it could

be, given adequate funding. The two tables appended to this statement reflect a

seven-year funding history for the DD Councils. It is notable that funding was cut

by 8 percent in fiscal year 1995 and has yet to return to the fiscal year 1995 level.

Councils are not able to keep pace with the growing needs in every State. With the

fiscal year 2001 Federal investment in Council activities of $67.8 million, the smallest 14 states receive $420,000 and the average allocation is less than $1 million,

far less than needed keep pace with the cost of living, let alone to fulfill the promises of the DD Act, including the requirements added in the recent reauthorization.

The lack of adequate funding has made it difficult to advance the independence and

inclusion of individuals with significant disabilities in every State.

To remedy this shortfall, the National Association of Developmental Disabilities

Councils (NADDC) urgently recommends an appropriation of $85 million for DD

Councils. This represents a restoration of the fiscal year 1995 cut, CBO cost of living

percentage increases for the past 5 years, and an additional $3 million for new requirements. Our sister programs, Protection and Advocacy Systems and University

Affiliated Programs have also languished since 1995 with insufficient funding and

NADDC recommends $35 million for P&As and $28.5 for UAPs. For Projects of National Significance, the only national research and development program targeted

especially to individuals with developmental disabilities, including the Family Support Program, we recommend $16 million. This totals $164.5 million the DD Act

programs need to keep up the momentum and to launch the necessary changes in

the new century.

PREPARED STATEMENT OF THE NATIONAL AHEC ORGANIZATION

Mr. Chairman, and members of the subcommittee, I am pleased to present testimony on behalf of the National AHEC Organization.

I am Project Director at the Northeastern Ohio AHEC, located in Rootstown, and

a member of the National AHEC organization. We are a professional organization

representing the Area Health Education Centers (AHECs) and Health Education
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and Training Centers (HETCs). Together, we seek to further the AHEC mission; to

enhance access to quality health care, particularly primary care and preventative

care, by improving the supply and distribution of health care professionals through

community and academic/educational partnerships. Health Education and Training

Centers (HETCs) have a similar mission to AHECs, but are unique in their focus

on public health matters associated with areas found along our nation’s border with

Mexico, the State of Florida, and other extremely underserved areas within our

country.

WHAT AHECS DO

Since our inception almost thirty years ago, AHECs, in partnership with local/

state/federal initiatives and educational institutions, have provided clinical training

opportunities to health professions and nursing students in underserved communities and have extended the resources of academic health centers to these locations.

Currently, there are 40 AHEC programs and more than 160 AHEC centers.

AHEC programs concentrate on four areas:

—Developing health care recruitment/preparation programs in underserved areas

for underrepresented and disadvantaged students. These efforts provide hands

on science and math instruction and exposure to local health professionals. Not

only is this an educational opportunity, but an encouragement for young people

to enter health professions careers.

—Oversee the community based training of primary care health professions students and residents in health professions shortage areas. AHECs are pioneers

in the effort to train residents in a community based setting. The contribution

of this type of training is immense to the healthcare workforce. It allows for individuals to complete their education in the locale they will serve. In 1998,

AHECs provided community based training to approximately 15,000 health professions students in underserved areas.

—Provide information, support, and technical assistance to health care professionals to ensure an opportunity for continuing education. In 1999, AHECs provided Continuing Education Programs for 174,425 participants.

—Promote healthy lifestyles in a manner which is appropriate to specific community and population needs.

AHEC’s play a vital role in integrating community needs, educational resources,

and health professionals. An example of this effort is the Canton Area Regional

Health Education Network, an AHEC Center, which operates a primary care project

in partnership with the Kent State College of Nursing. Primary health care nurse

practitioners, medical students, and allied health students provide a broad range of

care; screening for disease, education, and follow-up care, to migrant workers. Initially, this was limited to adults, but has since expanded to include immunizations

and primary care for children, as well as women’s health services.

THE ROLE OF HEALTH EDUCATION AND TRAINING CENTERS (HETCS)

The HETC programs are a subset of the National AHEC program, created with

the purpose of improving the number and placement of health professionals along

the border between the United States and Mexico, the State of Florida, and other

areas of extraordinary need. Like AHECs, the cooperation between faculty, students,

and communities serve as the base for HETC development.

In the state of Kentucky, in one year, over 6,000 disadvantaged students were involved in programs focusing on healthy lifestyles, violence prevention, and dental

health. This was achieved through partnerships among local schools, community

centers, Boy’s and Girl’s Clubs, and HETCs.

JUSTIFICATION FOR FUNDING RECOMMENDATIONS

Mr. Chairman, I respectfully ask the Subcommittee to support our recommendations of increasing the funding for the health professions and nursing education programs under Title VII and Title VIII of the Public Health Service Act to at least

$440 million. This is consistent with the funding level recommended by the Health

Professions/Nursing Education Coalition.

A 20 percent increase for the AHEC and HETC programs is needed for fiscal year

2002. Last year, no new AHEC programs were started. To enable AHEC programs

to expand service to states that currently have no program and strive towards completing a 50 state network, additional funding is crucial. AHEC programs have a

multitude of responsibilities, from recruitment of minority and disadvantaged students into health professions careers, to enhancing the quality of the health care

workforce through telecommunications training, telemedicine, distance learning, and

providing health career experience to K–16 students.
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1 Rennison, Callie M. (August 2000). Criminal Victimization 1999: Changes 1998–99 with

Trends 1993–99. Washington, D.C.: Bureau of Justice Statistics, U.S. Department of Justice,

Table 1. 2 National Victim Center & Crime Victims Research and Treatment Center. (1992). Rape in

America: A Report to the Nation. Arlington, VA: National Victim Center. P. 4.

HETCs provide training experiences for health professions students and local providers at sites of severe underservice to improve access to health care, diversity and

cultural competence of the healthcare workforce. One out of five U.S. citizens live

in a border HETC county. Within these areas, only 62 primary care physicians per

100,000 reside in border counties compared to 105 per 100,000 nationally. To help

alleviate this situation, each HETC project supports at least one training and education program for physicians and one for nurses so that a portion of the clinical

training for students is in the service area.

Mr. Chairman, thank you for the opportunity to present the views of the National

AHEC Organization. We look forward to working with you and your staff. I would

be happy to answer any questions that you or your colleagues may have.

PREPARED STATEMENT OF THE NATIONAL CENTER FOR VICTIMS OF CRIME

The National Center for Victims of Crime is the nation’s leading nonprofit advocacy and resource organization serving victims of all crime. Since its founding in

1985, the National Center has worked with nearly 10,000 public and private nonprofit organizations and agencies across the country, and has provided information,

support, and technical assistance to hundreds of thousands of victims, victim service

providers, allied professionals, and advocates.

One of the highlights of the Violence Against Women Act of 2000 (VAWA II) was

the increased resources to support rape prevention and education. This money funds

the rape crisis centers nationwide that provide support, counseling, community outreach, and education activities that are the nation’s best hope for making inroads

against this terrible crime.

While advocates cheered to see the increase as part of VAWA II, the President’s

fiscal year 2002 Budget proposes retaining the previous funding levels. Rather than

the $80 million authorized, the Administration proposes funding this important program at $45 million. We call on this Subcommittee to fully fund this important program.

THE IMPORTANCE OF RAPE EDUCATION

The incidence of sexual assault in this country remains high; despite an overall

drop in crime rates, there was a 20 percent increase in rapes, and a 33.3 percent

increase in sexual assaults in 1999.1 Rape prevention and education efforts are key

to ending sexual violence, by changing attitudes about rape and ending the isolation

of victims.

In the National Center’s 1992 landmark study, ‘‘Rape in America: A Report to the

Nation,’’ sexual assault victims were asked about the extent to which they were concerned about issues specific to their personal rape experiences. Rape victims reported that they were concerned about:

—her family knowing about the assault (71 percent);

—people outside her family knowing she had been sexually assaulted (68 percent);

and

—people thinking it was her fault or that she was responsible (69 percent).2

This combination of concerns may explain why so few rape victims report their

assaults. The Rape Prevention and Education Grants represent the best opportunity

for change.

Rape education changes attitudes; it is a direct response to the problem of victim

blaming which allows sexual violence to fester. Victims blame themselves: ‘‘If only

I hadn’t . . .’’ Their friends and family often judge them: ‘‘Why didn’t she . . .?’’ It

is only by education that victims will stop blaming themselves and society will stop

blaming the victims. It is only through education that blame can be shifted back

where it belongs: to the offender.

When that happens, victims will be more willing to reach out to the services they

need. Indeed, rape crisis centers around the country report that following public

awareness and education activities, more victims come forward to seek help. This

serves as a concrete indication of the importance of such education and outreach efforts.
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3 Canada Solicitor Genera. (1998). Multiple victimization (Canadian Urban Victimization Survey Bulletin No. 10). Ottawa: Ministry of the Solicitor General. 4Part of the Victims of Trafficking and Violence Protection Act of 2000 (H.R. 3244).

THE CONNECTION BETWEEN EDUCATION AND PREVENTION

Education about rape can prevent rape. As young people become aware of the frequency of acquaintance rape, they broaden their efforts to protect themselves from

merely locking doors against strangers to taking precautions with those they know.

Education is also key to reducing drug-facilitated sexual assault. As detection and

prosecution remains difficult, the best means to reduce such crimes is prevention

through education. Through education and public awareness efforts, young people

can learn to reduce their risk, and understand the warning signs that they or a

friend may have ingested Rohypnol, GHB, or other drugs commonly used to facilitate sexual assault.

As noted above, education also fosters requests for assistance. This, in turn, leads

to prevention of future assaults by reducing repeat victimization. In 1998, the Canada Solicitor General found that sexual assault victims are thirty-five times more

likely to be re-assaulted than individuals who were never assaulted.3 As education

prompts victims to seek services, they will get the support to reduce their likelihood

of revictimization. As one rape crisis director recently stated, ‘‘We have the opportunity in rape crisis agencies to explain to [victims] their risks and offer support

to help them decrease their vulnerability in a blameless manner.’’ Thus, there is a

direct connection between rape education and rape prevention.

PURPOSES OF FUNDING

As newly expanded under the Violence Against Women Act of 2000,4 rape prevention and education money can be used for:

—educational seminars;

—operation of hotlines;

—training programs for professionals;

—preparation of informational material;

—education and training programs for students and campus personnel designed

to reduce the incidence of sexual assault at colleges and universities;

—education and training to increase awareness about drug-facilitated sexual assault; and

—other efforts to increase awareness about, or to help prevent, sexual assault, including efforts to increase awareness in underserved communities and awareness among individuals with disabilities.

These are important efforts, that deserve to be fully funded. The lack of such full

funding directly impacts the ability of state and local organizations to reduce rape

in America.

From its conversations with sexual assault coalitions nationwide, the National

Center has learned of the dire need that exists for these prevention and education

funds. As examples:

—Approximately one out of six sexual assault programs in the National Center’s

referral database does not have a 24-hour toll-free hotline. In some states, there

is no hotline, and for centers that cover large geographic areas, calling the center may cost the victim and be reflected on the victim’s phone bill, violating her

confidentiality.

—In Alabama, less than half of the 15 rape crisis centers have a full-time outreach staff member. None of the programs have translated materials, and only

two have a bilingual staff member.

—Arkansas has no statewide sexual assault hotline, and no translated materials

or translators in sexual assault programs.

—In California, of 92 rape crisis centers, only 25 have translated materials.

—Of Georgia’s 21 rape crisis centers, only four have translated materials and 4

have a bilingual staff member. Furthermore, while the state has a law mandating sexual assault education in the schools, 50 counties have no rape crisis

program to provide this education, and the programs that do exist consistently

turn away requests for presentations due to lack of staff.

—Mississippi has nine rape crisis centers, but because of a lack of funds, twothirds have no community outreach program. The state coalition has received

requests to provide training regarding drug-facilitated sexual assault, but has

not had the money to develop such training.

—Ohio estimates that of its 40 rape crisis centers, only four have translated materials, and only six have a bi-lingual staff member.
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—The Pennsylvania Coalition Against Rape reports that 25 counties do not have

access to a full-time rape crisis education staff member. Moreover, in the last

year, rape crisis centers have turned down over 7,000 requests for programs/

presentations, largely due to a lack of staff and volunteers. As a result between

129,000 and 206,000 persons were not served.

—Of the 10 rape crisis centers in Utah, only one has translated materials. None

have bilingual staff. Only half have 24-hour hotlines. Three of the programs

have no full-time education staff member. The Utah Coalition Against Sexual

Assault reports they are only reaching 50 percent of the junior high and high

school students in the state through their education efforts.

—In Wisconsin, only three of the state’s 38 rape crisis centers have a full-time

community educator. Between one-half and two-thirds of the centers have only

one staff member.

When Congress increased the authorization for the Rape Prevention and Education Grants as part of VAWA II, it recognized the importance of this program in

reducing sexual victimization. The National Center calls on Congress to honor its

commitment to women by providing full funding for the Rape Prevention and Education Grant Program for fiscal year 2002.

For more information, contact Susan Howley, public policy director, National Center for Victims of Crime, at (703) 276–2880.

PREPARED STATEMENT OF THE NATIONAL COALITION FOR HEART AND STROKE

RESEARCH

My name is Jack Owen Wood. I solicit your support for more aggressive federal

funding for research into prevention and treatment of the sister diseases, stroke and

heart disease. Strokes and heart attacks are occurring at an alarming rate.

I am representing the National Coalition for Heart and Stroke Research. The coalition consists of 14 organizations representing more than 5 million volunteers and

members united in support for increased funding for heart and stroke research.

Members of the Coalition include: American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation; American Association of Neurological

Surgeons; American College of Cardiology; American Heart Association; Americans

for Medical Progress Congress of Neurological Surgeons; American Neurological Association; Association of Black Cardiologists; Citizens for Public Action on Blood

Pressure and Cholesterol, Inc.; Mended Hearts, Inc.; North American Society of Pacing and Electrophysiology; Stroke Connection, Inc.; and the National Stroke Association.

I will deal primarily with one man’s personal experience with stroke and its functional and financial costs—my own. I have only the use of my right arm.

I was born in 1937, raised in Vicksburg, Mississippi, earned an engineering degree at Mississippi State University and currently reside in Port Orchard, Washington.

I worked for the Boeing Company in Seattle, am a former Director of the Washington State Energy Office, served as Director of Cost and Revenue Analysis and

as the Forcasting Manager for a major Northwest Area Natural Gas Utility until

May 1, 1995.

On May 1, 1995, at the age of 57, I was stricken and severely disabled by my

stroke. Two years later I experienced a triple bypass heart operation. You might say

I’ve ‘‘been there and done that’’ for both major cardiovascular diseases. So you see,

I am an expert.

Last year I was offered an exciting and rewarding volunteer opportunity. I was

asked to lead the ‘‘JACK WOOD STROKE VICTOR TOUR’’ for the American Heart

Association.

The JACK WOOD STROKE VICTOR TOUR was a 5-state lobbying tour. Through

it I tried to meet personally with every Northwest Congressional representative on

his or her home turf (in Alaska, Idaho, Montana, Oregon and Washington). In each

meeting I was joined by local people, stroke survivors and their families and medical

professionals. I told my story and asked them to join the Congressional Heart and

Stroke Coalition and to support increased federal heart and stroke research funding.

I am proud to say I traveled to 18 communities and meet personally with 28 members of our delegation or their staff. Nearly half of our congressional delegation is

now members of the Congressional Heart and Stroke Coalition.

One of the most powerful memories for me was the frequency in which Members

of Congress or staff members related their personal experience with stroke. One

member I spoke to lost both parents to stroke. I suspect many of you have stories

too.
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I realize your interest is greater than the physical impact of my stroke. Your concern must include the financial impact, not only on me, but on our country from

increased health care costs and lost productivity and its many implications.

I have confronted the difficult and painful task of calculating that cost to me. Besides being a man whose stroke took his ability to pick up and play with his grandchildren, his livelihood, and marriage, I remain a statistician at heart. I couldn’t resist calculating and telling that part of my story. But please remember my story

is not dissimilar to that of many of the 4.5 million stroke survivors in the United

States. Many of whom were stricken in their prime earning years. Who in a matter

of moments, seemingly without warning, are transformed from a contributor and

provider to a receiver and patient.

My full analysis is on the final page of my written testimony. Allow me to highlight three figures that I feel sum up my data and should be important to you. I

estimate that my stroke at age 57:

—Reduced my earnings before retirement age 65 by over $600,000.

—Subsequently, the cost to the federal government in lost income and other taxes,

early Medicare payments and Social Security disability payments is over

$320,000.

—My HMO spent approximately $150,000 to respond to and treat my stroke.

—One man, over one million dollars.

About 600,000 Americans will suffer a stroke this year costing this nation an estimated $45 billion in medical expenses and lost productivity.

Earlier I described a stroke as occurring seemingly without warning. All too often

as in my case, people either don’t know or ignore the signs of a stroke, even one

in progress. When my stroke hit I denied it. It took me two days after my stroke

to acknowledge it and seek help. Because of research into new treatments, we now

have t-PA, which if administered within 3 hours of the onset of stroke symptoms,

can dramatically reduce the damage of certain kinds of strokes. Had I recognized

and acknowledged my stroke, gone to a hospital with a neurologist on staff and had

there been tPA, the impact of my stroke most certainly would have been lessened.

What is even more painful to me is that my impending stroke could have been

detected. Unfortunately, we need to create easier and less expensive diagnostic techniques so that effective diagnostics can be given routinely as part of regular health

exams. And they must be covered through insurance.

I am not asking for your sympathy. Instead, please think of me as two of the

ghosts in the famous Dickens’ story. Please don’t misunderstand, I’m not casting you

as Scrooge. See me as both the ghosts of things past and things yet to be. I too am

here to tell you, the future, which I represent, needs not be. It is largely up to you.

I hope my story and estimate of the cost of my stroke convinces you that taking

on stroke and heart disease through increased research, leading to better prevention, diagnosis and treatment is fiscally responsible. The human and financial costs

are astronomical.

Thank you for your past support of research and recent decision to eliminate (at

least for now) restrictions on reimbursement for rehabilitation services, essential to

those who have experienced a stroke. Please continue and broaden that support.

PREPARED STATEMENT OF THE NATIONAL FUEL FUNDS NETWORK

INTRODUCTION

The National Fuel Funds Network thanks the members of the Subcommittee for

the opportunity to submit this testimony. We thank the Chairman and other subcommittee members for your efforts in securing $1.86 billion in sorely needed energy

assistance funding for fiscal year 2000.

The National Fuel Funds Network (NFFN) supports funding for the Low-Income

Home Energy Assistance Program (LIHEAP) in the amount of $2 billion in regular

funds plus $300 million in emergency funds, the maximum amount authorized for

fiscal year 2002. NFFN also supports advance funding in the amount of $2 billion

for fiscal year 2003. The Network also supports the Bingamin amendment to the

bankruptcy reform bill, which authorizes $3.4 billion for LIHEAP.

The NFFN is a membership organization comprised of over 200 dues-paying representatives of private fuel and energy assistance funds, community action agencies,

social service organizations, utility companies, local and Tribal governments, trade

associations and private citizens. Our member organizations are located in 44 states

and the District of Columbia.

The NFFN members raise private contributions in their local communities or

states to assist people with low incomes to pay home energy bills. Fuel funds range
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from small church organizations that distribute hundreds of dollars in a single

neighborhood to large independent organizations that distribute millions of dollars

across a state. Fuel funds may be a division of a large social service agency, or a

local utility or energy company may operate them. Some Indian tribes maintain fuel

funds to supplement LIHEAP programs. Since our first steering committee meeting

in 1984, the NFFN and its member organizations have put into action a commitment to help people of limited means, due to chronic poverty and temporary misfortune or illness, meet their basic energy needs.

Whatever their form, all fuel funds raise and distribute private sector monies, and

they all, inevitably, discover that the resources they manage and the resources provided by LIHEAP are inadequate. Therefore, fuel funds are becoming increasingly

involved in attempting to locate or direct even more financial resources to help the

poor meet their energy needs.

Nationally, fuel funds assist almost 1.8 million households to make heating and cooling bill assistance payments of over $102 million this year. These payments,

while vitally needed, are quite small in comparison to the $1.86 billion in fiscal year

2000 LIHEAP funding.

During the 1990’s there was a consistent demand for energy assistance funding

despite the fact it was one of the warmest winter decades on record. The households

assisted during this period were among the poorest of the poor with average household incomes of less than $8,000 per year in most states for a family size of 2.6.

A 1999 NFFN survey revealed that many fuel fund managers reported an increase in their energy assistance caseloads due in part to the 1996 Welfare to Work

legislation.

Fuel Funds have worked vigorously to raise private non-federal funds to assist

needy households during the last decade, raising $74 million in 1994, $88 million

in 1998 and an estimated $100 million this winter.

Despite these valiant efforts, the amount of funds raised by fuel funds is very

small compared to federal LIHEAP funds of $1.86 billion for his winter.

The current 2000/2001 winter has highlighted the need for not only continued but

increased LIHEAP funding.

IMPACT OF RISING ENERGY PRICES

The increases in energy costs this winter, especially natural gas has greatly increased the energy burden i.e. the ratio of energy costs to household income borne

by poor households. As you know, natural gas prices this winter have averaged, at

times, three to four times the prices paid last year. In addition, the weather across

most of the country this winter was not only considerably colder than last winter,

but colder than normal, with records set in some areas.

The combination of colder weather and dramatically higher energy costs have imposed an unbearable energy burden on the poor.

A December 2000 study by Economic Opportunities Studies estimated the energy

burden for poor households this winter would be 19 percent for households with incomes of 125 percent of poverty and 14 percent for households at 60 percent of the

average of the states’ median incomes compared to 3.2 percent for middle-income

households not eligible for assistance.

The above energy burdens were based on a projected natural gas price increase

of 40 percent above the 1999–2000 winter. Current estimates indicate natural gas

prices will average 60 percent more above last winter, thus imposing an even greater burden on the poor.

Moreover, by the time the heating season and cut off moratoria ended, millions

of households faced utility cutoffs because of arrearages amassed during the winter.

Indeed, a recent National Energy Assistance Directors Association study tallies 3.6

million households in only eighteen states.

FUEL FUNDS RESPONSE TO CRISIS

Fuel Funds, in response to the above escalations in energy costs and colder weather have aggressively stepped up their fundraising and service delivery efforts.

For example, the Victorine Q. Adams Fuel fund in Baltimore City anticipates

servicing 50 percent more households this winter compared to last winter or 3,000

vs. 2,000 respectively.

The Dollar-Help program in St. Louis has increased its fundraising from about

$550,000 two years ago to an estimated $800,000 this winter and will serve about

2,500 households this winter as compared to 2,000 in 1999.

KeySpan Energy recently announced a $3 million in grants to fuel funds serving

New York City, Long Island and New England. Entergy—New Orleans donated $1

million to two fuel funds in that city.
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NFFN estimates contributions to fuel funds are up at least $12 million this year for a total of $100 million vs. $88 million raised in 1998–99.

Local and state governments have also increased their funding of energy assistance in their jurisdictions. In Ohio Governor Taft committed $2.5 million in state funds for energy assistance

and challenged the state’s utilities to match the state’s commitment. In response,

Columbia Gas of Ohio formed the Columbia Energy Assistance Fund with $3.5 million, Dominion East Ohio Gas expanded the People Helping People Fund with a $1

million contribution and Cinergy expanded its Heatshare program from $100,000 to

$500,000.

Some cities have used a portion of their increased Gross Receipts tax revenues

to fund energy assistance efforts through Community Action Agencies and fuel

funds.

In the city of St. Louis, the Board of Aldermen and the Mayor appropriated $1.13

million for energy assistance. In western Missouri, several cities either reduced

their Gross Receipts taxes or donated a portion for energy assistance.

The above efforts, while worthy of praise are small when compared to the LIHEAP funding for this winter of $1.86 billion. Therefore, it is clear that the most

ambitious private efforts cannot replace LIHEAP. These private efforts, when used

in partnership with LIHEAP serve as a very helpful safety net supplement to the

very needy.

Most states have experienced dramatic increases in applications for assistance

this winter as a result of the severe weather and energy cost increases. Many of

the agencies responsible for delivering assistance are experiencing large backlogs

due to a shortage of modern computers and electronic capability such as e-mail.

Approximately half way through the 2000–2001 heating season in Colorado, more

than 49,585 households have been approved for energy assistance through the

LIHEAP program. This number exceeds the caseload of 48,417 households served

during the entire 6 month heating season in 1999–2000. Applications for assistance

set records exceeding the number of applications ever to have been accepted by the

state administered federally and privately funded LIHEAP program.

Privately funded non-profits, charities and faith-based organizations have also

seen caseloads up by more than 50 percent from last year serving in excess of an

additional 10,000 households not currently served by LIHEAP.

Call volumes to my agency, Colorado Energy Assistance Foundation show astronomical increases rising from approximately 25 calls a day in January and February

to recorded levels of 543 calls per day. Averages are running in the neighborhood

of 270 calls per day.

To ease the problem of backlogs and to avoid the non-delivery of sorely needed

help, NFFN recommends the use of a portion of LIHEAP appropriation for the purchase of new sorely needed delivery equipment.

The summer of 1995, with its oppressive heat and loss of lives taught us that energy assistance is a year around issue and the need for LIHEAP funding is almost

constant.

As evidenced by this winter, the volatility in energy prices experienced this winter, as well as cold weather can wreak havoc on the lives of the poor.

In St. Louis, for example some lenders are offering to refinance mortgages for people to pay increased heating bills.

CONCLUSION

In conclusion, NFFN strongly supports and urges the approval of a fiscal year

2002 LIHEAP appropriation of $2.3 billion, $2 billion in regular funding and $300

million in emergency funds. We also urge the Subcommittee to provide advance appropriations for fiscal year 2003 at the same level. State and Tribal agencies need

advance funding to insure stability and continuity. This holds especially true in a

time of volatile home energy prices.

Fuel Funds will continue their efforts to serve as a helpful safety net supplement

to LIHEAP but cannot in any way replace the vital role LIHEAP plays in the lives

of the poorest of our neighbors.

NFFN is grateful for this opportunity to submit testimony the Subcommittee.

PREPARED STATEMENT OF THE NATIONAL INDIAN CHILD WELFARE ASSOCIATION

The National Indian Child Welfare Association appreciates the opportunity to

submit testimony regarding fiscal year 2002 funding child welfare and mental

health programs that serve our most precious resource—our children. Our comments will focus on the need for mental health services for Indian children and for
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research and services related to abuse and neglect of Indian children. Specifically,

we need increased resources and/improved access to the following DHHS programs:

(1) Substance Abuse and Mental Health Services Administration (SAMHSA) programs:

—Knowledge, Development and Application category—Circles of Care tribal children’s mental health grant program

—Comprehensive Community Mental Health Services for Children and their

Families grant program—funding for tribal children’s mental health service

sites.

(2) Administration for Children and Families (ACF) Office of Child Abuse and Neglect under the Child Abuse Prevention and Treatment Act (CAPTA) programs:

—National Clearinghouse for Child Abuse and Neglect Information and

—Child Abuse Research and Demonstration.

(3) There are barriers to funding services for Indian children, especially in the

Foster Care and Adoption Assistance programs, the Mental Health Block Grant, and

the Child Abuse Prevention and Treatment Act state grants.

The National Indian Child Welfare Association (NICWA).—NICWA, headquartered in Portland, Oregon, provides a broad range of services to tribes, Indian

organizations, and state and federal agencies that serve Indian children and families throughout the United States. These services are not direct client services such

as counseling or case management. Rather, they are services that strengthen the

programs that serve Indian children and families. Our services include: (1) professional training for tribal and urban Indian child welfare and mental health professionals; (2) technical assistance to improve child welfare and mental health programs that serve Indian children; and, (3) activities to promote improved public policy for Indian children and families. In addition to maintaining a strong network

in Indian country by working closely with the National Congress of American Indians and tribal governments across the nation, we have established mutually beneficial partnerships with organizations including the Federation of Families for Children’s Mental Health, the Child Welfare League of America, and Casey Family Programs.

Program.—Circles of Care tribal grantees under the budget category of Knowledge, Development and Application (last year for this 3-year grant program is fiscal

year 2001).

Fiscal year 2001 Enacted.—$2.4 million (approximately $0.7 million was reserved

for the Circles of Care grant program).

DHHS Division.—Substance Abuse and Mental Health Services Administration.

Recommendation.—$3 million, with $1.1 million for the Circles of Care projects

Justification.—The Circles of Care projects utilize the most current and innovate

thinking in delivering Indian children’s mental health services. The current nine Indian community grantees, which base their efforts in ‘‘a system of care’’ model, are

engaging local communities in partnerships and capacity building for children’s

mental health services. Within the field of children’s mental health, a system of care

is a formal collaboration of the family and community members, professional and

other organizations committed to enhancing the lives of emotionally disturbed children and their families.

All of the Circle of Care Indian projects are subject to rigorous external evaluation

which helps determine the feasibility of project designs and also the potential for

successful replication in other communities.

Historically, American Indians/Alaska Natives have had little access to mental

health services, and funding from Indian Health Service for this purpose has been

minimal. Funding planning efforts is critical to the successful building of systems

of care for American Indian/Alaska Native children with severe emotional disturbances. We ask Congress to provide additional planning grants so that other tribes

and urban Indian organizations can enter into partnerships with Indian and nonIndian agencies to develop community-based mental health programs.

The Circles of Care programs are demonstrating that careful planning combined

with community partnerships can make a positive difference in helping children

with severe emotional disturbances and their families.

Program.—Comprehensive Community Mental Health Services for Children and

their Families grant program (tribal service site funding).

Fiscal year 2001 Enacted.—Approximately $91.7 million.

DHHS Division.—Substance Abuse and Mental Health Services Administration.

Recommendation.—Recommend (1) reserve 10 percent of the total allocation to

this program for tribal applicants and (2) exempt Indian tribes and organizations

from population limits used to allocate these grant funds.

Justification.—Developing systems of care for Indian children with, or at risk of,

emotional and behavioral disorders has been initiated through the Children’s Men-
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tal Health Services tribal service grantees. To date, seven tribal sites have received

grant awards. Information and descriptions of the most ‘‘promising practices’’ of the

full range of the mental health services are being documented in the Promising

Practices monograph series. The monograph devoted to the Native American grantees was released in June 2000. This monograph poignantly illustrates the success

of community-based systems of care when American Indian communities are afforded the advantages of designing systems tailored to their specific needs.

Focusing on cultural and family strengths, parent and community involvement,

and ongoing service evaluation, the service sites yield rich information useful to Indian and non-Indian providers. Substantive data gathering is an integral part of

tracking the success and challenges of implementing new systems of care in Indian

country. The verbal reports of parents and children enrolled in some of the project’s

systems of care suggest a high rate of success and demonstrate high consumer satisfaction by parents and children. A 10 percent allocation would enable funding of additional sites that are in desperate need for children-specific mental health services.

The formula for funding grantees only allows a specified number people to be

served within a given state. If a state becomes a grantee it would almost automatically exclude any American Indian/Alaska Native tribes from being awarded a grant

in that same state even though they would be serving different populations and

using a different service delivery system. Many states have numerous tribes in rural

areas with small populations. We believe that the program should fund tribes in a

way that honors the government-to-government relationships. An allocation of dollars to these Native populations that is unrestricted by state populations addresses

the inordinately high index of need for mental health services of American Indian/

Alaska Native children.

Program.—National Clearinghouse for Child Abuse and Neglect Information,

Child Abuse Research and Demonstration.

Fiscal year 2001 Enacted.—$33 million (no portion of these funds are reserved for

a Tribal grant program, but Tribes receive services from the clearinghouse as well

as a few discretionary grants).

DHHS Division.—Office of Child Abuse and Neglect.

Recommendation.—Recommend an allocation of at least $2 million to support research, information services and demonstration projects in American Indian communities.

Justification.—Beginning with the passage of the Indian Child Welfare Act in

1978, tribes began in earnest to reclaim their responsibility for the protection of

tribal children (Canby, 1998). Today almost every tribe in the nation provides some

form of child welfare services to their children, and approximately two-thirds are directly involved in the investigation of cases of child abuse and/or neglect (Earle,

2000). Efforts to address the problems of abuse/neglect of Indian children living on

tribal lands are hampered by the fact that no one knows how widespread the abuse/

neglect of Native children really is. Although there are various sources of data for

the rates of abuse/neglect of Indian children, the accuracy of these data is suspect

not only due to problems of definition and limited scope but to the inability to collect

accurate data on the known cases of child abuse/neglect.

U.S. Bureau of Justice statistics for 1995 reported a per capita rate of one substantiated report of a child victim of abuse or neglect for every 30 American Indian

children aged 14 or younger. This compares to one report for every 58 children of

any race, approximately half the rate for Native children. It was the highest rate

of abuse or neglect reported for any ethnic group. In addition, American Indians and

Asians were the only racial/ethnic groups to experience increases in the rate of

abuse or neglect of children under age 15 from 1992 to 1995 (Dept. of Justice, 1999).

Data from the National Child Abuse and Neglect Data System (NCANDS) show

that, for child maltreatment victimization rates by race and ethnicity in 1998 (40

states reporting), the rate for Native children was 19.8 cases per 1000 children. This

compares to a rate of 3.8 for Asians/Pacific Islanders, 8.5 for Whites, and 10.6 for

Hispanics (U.S. Dept. of Health and Human Services, Children’s Bureau, 2000).

Tribes and policy makers desperately need research on the extent of the problem

and information about how to combat child about in their communities.

STATUTORY AND REGULATORY BARRIERS TO FUNDING SERVICES FOR INDIAN CHILDREN

While we recognize this Committee does not have the authority to amend language in the authorizing statutes, we feel it is important that the Committee be

aware of the disparity in access to federal funding that exists for Indian children.

Therefore, we are providing information on key programs that have the potential

to fund services for Indian children under tribal jurisdiction, but contain significant
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barriers. The appropriations for these programs, however, do fall under the purview

of this Subcommittee.

Program.—Foster Care and Adoption Assistance (Title IV–E of the Social Security

Act).

Fiscal year 2001 ENACTED.—Entitlement funding $5 billion (foster care) and $1.2 billion (adoption assistance).

DHHS Division.—Children’s Bureau under the ACF.

Recommendation.—Support legislation (to be introduced in the Senate in March)

to include tribal governments as eligible for direct reimbursement for Title IV–E

services they provide to eligible Indian children under their jurisdiction and care.

We point out that the American Public Human Services Association, the organization of state social service agencies, has recently formally endorsed the provision of

direct funding to tribes under the IV–E statute.

Justification.—While Congress intended for the Title IV–E program to serve all

eligible children in the United States, Indian children under the jurisdiction of a

tribal government and living on tribal lands do not have an entitlement to this important program afforded other children. The statute provides services only for income-eligible children placed by states and public agencies with which states have

agreements. While approximately 70 tribes have been able to forge agreements with

a state to access Title IV–E funds, the vast majority of tribes have no access. In

those states where agreements exist, tribes often receive only a portion of the funding available overall to support foster care and adoption related services. With no

stable source of foster care and adoption assistance funding, tribes have struggled

to provide the same level of protection and permanency that other children are

guaranteed under this federal program. By enacting the soon to be introduced legislation in the Senate that would add tribes to Title IV–E, the federal government

can provide a higher level of security and permanence for Indian children than

would be found in any other federal funding source.

Program.—Mental Health Performance Partnership Block Grant.

Fiscal year 2001 Enacted.—$420 million.

DHHS Division.—Substance Abuse and Mental Health Services Administration

Recommendation.—We recommend the authorizing statute be amended to provide

tribal governments direct access to the Mental Health Block Grant. We recommend

that 3 percent of the overall appropriation be reserved for direct allocation to tribal

governments. To fund this recommendation without impacting state allocations, we

also recommend increasing the overall level of appropriation by 3 percent. The specific allocation for individual tribes could be based on a formula that would be similar to the one used for the allocation of tribal funds from the Child Care and Developmental Block Grant. This formula provides a base amount of funding for every

tribe, in addition to a per capita amount based on the tribe’s population.

Justification.—Tribal governments do not have access to the Mental Health Performance Partnerships Block Grant and therefore miss out on funding opportunities

to support mental health services for both Indian adults and children. These monies

are distributed by formula to state and territorial governments, but not to tribal

governments. Additionally, tribes and tribal organizations are eligible applicants for

only some of the discretionary mental health grants under the Substance Abuse and

Mental Health Administration. Mental health block grants not only can address immediate mental health needs, but also support long-term capacity building for tribes

and the communities they represent.

Program.—Promoting Safe and Stable Families Act (Title IV–B , Subpart 2 of the

Social Security Act).

Fiscal year 2001 Enacted.—$305 million capped entitlement.

DHHS Division.—Children’s Bureau under ACF.

Recommendation.—Amend the authorizing legislation to increase the amount of

reserved funds for tribal governments from 1 percent to 3 percent of the overall appropriation. Current levels of funding and the statutory language only allow 66 tribal grantees to be eligible to receive funding under this program.

Justification.—This program is part of an overall federal system of child welfare

funding designed to support a more comprehensive array of program services in

child welfare. Title IV–B, Subpart 2 helps promote services to prevent the removal

of children from their homes, reunify them with their families after removal when

possible and provide services to support adoption when return to the home is not

possible. As an indicator of need, Indian children in the United States are placed

in substitute care at a much higher rate than is the average for all other children

in the nation. 12.5 out of every 1,000 Indian children are placed in substitute care,

compared to 6.9 out of every 1,000 children from all races (Child Welfare League

of America, 1996, with 34 states reporting substitute care data). This funding has

been a good fit for tribes who have been eligible to receive grants. However, with
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only a small portion of the total number of federally recognized tribes eligible, the

program has had little impact on the overall need for these services in tribal communities across the United States. One of the primary purposes of the program was

to stimulate systems change, a goal that is definitely needed in child welfare, but

again, the small amount of funding and restricted eligibility has made it very difficult to create and sustain any meaningful change for tribal governments.

Program.—State grants under the Child Abuse Prevention and Treatment Act

(CAPTA).

Fiscal year 2001 Enacted.—$21 million.

DHHS Division.—Office of Child Abuse and Neglect.

Recommendation.—We recommend that the authorizing statute be amended to

provide tribal governments direct grants for child abuse prevention and treatment

programs. Tribes receive no funding under the state grants.

Justification.—Given sharply increasing reports of maltreatment, (Greenfeld and

Smith, 1999) prevention programming must be expanded in American Indian communities. While Indian people have a heritage for child protection, we also have a

growing problem with child abuse and neglect. If we are to survive as nations, we

must turn this around. It is essential that Tribes build the capacity to conduct comprehensive child abuse and neglect prevention and treatment programs. National attention on this topic is needed. It is our belief that direct tribal grants under

CAPTA will be helpful in shaping future of our children.

PREPARED STATEMENT OF THE NATIONAL LATEX ALLERGY NETWORK

On behalf of the National Latex Allergy Network (formerly ELASTIC Inc.), a nonprofit voluntary health organization, and the 2.3 million Americans estimated to be

sensitized to natural rubber latex. I would like to thank Senator Specter, Ranking

Member Senator Harkin, and Members of the Subcommittee for the opportunity to

provide written testimony.

We are respectfully requesting that the Senate subcommittee allocate federal

funds to facilitate and advance research in the area of latex allergy. Scientists from

all over the country are working very hard to help the growing number of people

who are becoming sensitized to latex. There is a critical need for financial support

in all areas of research, including pathophysiology, existing and unknown causative

factors, occupational asthma, diagnostics, immunotherapy, product and environmental safety standards, treatment standards and prevention strategies.

Increased use of latex, most notably, latex gloves, to prevent infectious diseases

has been followed by an increase in the number of people affected by latex allergy.

In 1991, the FDA issued a medical alert in response to growing reports of allergic

reactions by patients to latex-containing medical devices. At this same time the

CDC was investigating clusters of anaphylactic reactions among young patients undergoing treatment at various children’s hospitals across the country.

The explosion of anaphylaxis and serious allergic reactions to latex gloves and

other medical equipment shocked physicians, researchers and regulatory government agencies because, quite simply, prior to the mid-1980’s, latex allergy was virtually unheard of.

Latex, or more accurately, natural rubber latex, is harvested from the Brazilian

rubber tree found in Africa and Southeast Asia. The culprits are certain allergenic

proteins retained in varying amounts in finished products such as gloves, medical

equipment, balloons, condoms and toys. With the exception of medical gloves and

other medical devices, there are no regulations for content labeling or warnings.

How a product is made determines the amount of latex allergens retained in the

finished item. Currently, there are no federal regulations that limit the amount of

allergenic proteins in finished products. The FDA Center for Medical Devices and

Radiological Health is in the process of finalizing recommendations for maximum

levels of extractable protein and powder per glove for medical exam and surgeon’s

gloves. This has been a lengthy effort and applies only to the medical gloves regulated by this agency.

A joint statement of the American Academy of Allergy, Asthma & Immunology

and the American College of Allergy, Asthma & Immunology published in 1997 defines latex allergy as an IgE-mediated latex allergy that results from cumulative exposure of susceptible individuals to natural latex rubber proteins (allergens) and

identify medical gloves and equipment as the largest single source of exposure to

these potent allergens. Exposure to bio-available latex allergens is by direct contact

with an offending device or by inhalation of allergens carried by cornstarch powder

with which most powdered gloves are coated. The clinical manifestations of latex allergy range from mild contact urticaria to fatal anaphylaxis.
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Latex allergy, an IgE-mediated reaction to proteins retained in finished natural

rubber latex products, has emerged in the 1990s as one of the most pervasive problems in medicine, affecting both patients and health care providers. ‘‘Latex allergy

has resulted in death, progressive asthma, severe food allergy from cross-reactivity,

and disability of health care professionals with the accompanied loss of self-esteem

and income as a result of their inability to work in their chosen profession.’’ (Kelly

KJ, Walsh-Kelly CM—Latex allergy: A patient and health care system emergency.

J Emerg Nursing Dec 1998 24;6:539–545)

While similar to peanut, stinging insects and drug allergies in the risk for lifethreatening anaphylaxis, latex allergy is unique in that the latex gloves and other

medical products used in emergency situations to save a life could cause a fatal

anaphylactic reaction.

Since the early 1990s, the FDA has received over 2,000 adverse event reports describing allergic reactions to medical gloves containing natural rubber latex. These

reports relate both to patients and users of natural rubber latex products. These reports include 16 deaths, 5 caused by latex gloves.

While working as a general dentist, I had never heard of latex allergy, let alone

had any inkling of the enormous burden it would impose on my family, the dilemma

it would pose for my health care providers and the debilitating effect it would have

on my health. That is, not before the summer of 1994 when I was diagnosed with

latex allergy and asthma caused by the latex gloves I wore everyday and the ‘‘second-hand latex’’ from the latex-laden powdered gloves everyone in the office used.

Nor did I think that something so innocuous that I would lose my practice and

become so chronically ill those even day-to-day activities would be nearly if not totally impossible. Who would have thought the very products we used everyday as

health care providers would end my career in dentistry and impose an enormous

physical, emotional and financial burden on my family?

Latex glove use has spilled over to non-medical settings, so much so that a Philadelphia nurse and latex allergy prevention advocate has developed a new spin on

an old nursery rhyme. ‘‘Butcher, baker, beautician, thief, mechanic, chef, fire

chief . . . the common denominator here is routine latex glove use! The list of occupations also wearing gloves for barrier protection includes; farmers, produce pickers,

factory workers, restaurant and food service workers, day care workers, dog

groomers, landscapers, painters, toll collectors, auto factory workers as well as florists, housekeeping and janitorial service workers, students for science, art and shop

classes.

Latex allergy develops primarily because of repeat exposure to significant levels

of allergenic proteins retained in finished products made from natural rubber latex

(NRL), in particular latex gloves and other medical equipment that contact mucosal

tissues.

The transfer of allergenic latex proteins from glove surfaces to food products has

been scientifically documented resulting in an often hidden source of latex exposure

for consumers. Disposable latex gloves, commonly utilized by food handlers, are a

source of indirect food additives violating Section 402(a)(1) of the FDA Food Regulations which state: ‘‘A food is illegal (adulterated) if it bears or contains an added

poisonous or deleterious (harmful) substance which may render it injurious to

health.’’

Health risks to consumers and workers associated with latex glove use in all aspects of food service—from farm to table. As stated in the 1999 Food Code Annex

3 3–3–4.15; 3–304.15—Gloves, Use Limitation—‘‘Natural rubber latex gloves have

been reported to cause allergic reactions in some individuals who wear latex gloves

during food preparation, and even in individuals eating food prepared by food employees wearing latex gloves (refer to Annex 2 for this section).’’ The FDA is currently evaluating safety issues associated with latex glove use in the food industry.

Avoidance of latex allergens is presently the only method to prevent reactions,

latex-related asthma and latex sensitization. Commonplace use of medical and nonmedical latex gloves as well as hundreds of other products encountered in daily life

makes this task extremely difficult. Ironically, the prevalence of latex in gloves and

other life-saving equipment used by first responders, emergency medical service providers, emergency rooms and hospitals, has resulted in a critical public health crisis—access to safe emergency and routine health care for the growing number of

latex allergic patients.

Mr. Chairman, I thank you again for the opportunity to provide the Committee

with information about this newly emerged disease, latex allergy. Government agencies are working hard to provide product and environmental standards and guidelines. Federal funding for medical research would provide the thousands of families

affected by latex allergy a source of hope for universal access to safe health care,

safe school and work environments and especially hope for a cure. Please help us
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advance and expedite treatment and a cure for latex allergy by providing funding

for research.

PREPARED STATEMENT OF THE NATIONAL DOWN SYNDROME SOCIETY

Chairman Stevens, Members of the Committee: The National Down Syndrome Society is pleased to submit written testimony in support of improved health care for

individuals with mental retardation, including people with Down syndrome.

NATIONAL DOWN SYNDROME SOCIETY (NDSS)

The National Down Syndrome Society represents more than 350,000 individuals

with Down syndrome who live in the United States, their families, friends and professionals who serve them. The National Down Syndrome Society was established

in 1979 to ensure that all people with Down syndrome have the opportunity to

achieve their full potential in community life. Since that time, NDSS has become

the largest non-governmental supporter of Down syndrome research in the United

States. Today, NDSS continues to increase public awareness about Down syndrome

and discover its underlying causes through research.

Under the leadership of a Board of Directors, Scientific Advisory Board, Clinical

Advisory Board, Affiliate Advisory Board and Self-Advocate Advisory Board, NDSS

distributes timely and informative materials, supports activities of local parent support groups, sponsors conferences and scientific symposia and undertakes major advocacy efforts—all to help improve lives of people with Down syndrome.

More than 125 parent support groups and related member organizations comprise

the NDSS Affiliate Program. The NDSS affiliate members form the grassroots structure of the organization and represent thousands of individuals with Down syndrome and their families from around the country.

DOWN SYNDROME

Down syndrome is the most commonly occurring chromosomal abnormality, occurring in approximately one in every 800 to 1,000 live births. There are approximately

6,000 people born with Down syndrome in the United States each year and thousands more impacted by this genetic condition. Most people with Down syndrome

have some degree of mental retardation, usually in the mild to moderate range.

Children with Down syndrome are at increased risk for certain health problems.

Congenital heart defects (50 percent), endocrine problems (10 percent), neurological

conditions (10–20 percent), increased susceptibility to infection, respiratory problems, obstructed digestive tracts and childhood leukemia occur with greater frequency among children who have Down syndrome. Adults with Down syndrome are

at a significantly increased risk for Alzheimer’s disease (25 percent), dental problems, thyroid concerns, musculoskeletal problems and depression. These, of course,

do not include the many other kinds of health care problems that everyone in the

population is susceptible to.

Today, the average life expectancy of individuals with Down syndrome is approximately 55 years, with many living even longer. As this population ages, the need

for access to adequate health care and for well-trained professionals to address

these needs, becomes even more critical.

HEALTH CARE PROBLEMS FOR PEOPLE WITH DOWN SYNDROME

While advances in medicine have rendered most of these health problems treatable, some people with Down syndrome do not have access to necessary care. NDSS

has identified the following major health care issues, based on speaking to many

of our constituents:

—Physicians and health care professionals not adequately trained to meet the

medical and health care needs specific to individuals with Down syndrome.

—Access to health care and surgical procedures being denied to individuals with

Down syndrome based on discrimination and attitudes, rather than medical necessity.

—People being denied health insurance on the basis of Down syndrome being considered a ‘‘preexisting condition.’’

These problems with the current systems as they relate to individuals with Down

syndrome represent just some of the issues we hear.

THE CHALLENGE

Throughout the years, NDSS has heard hundreds of stories from parents about

insensitive attitudes on the part of health care professionals, whether in presenting
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a diagnosis of Down syndrome or in treatment, as well as professionals being inadequately prepared with the necessary information and resources to work with their

child. NDSS has also been contacted by numerous physicians, nurses, social workers, genetic counselors and others seeking information and resources that will help

them to better care for their patients who have Down syndrome. There is very limited training available for health care professionals on how to address the specific

needs of people with Down syndrome.

There are many resources available, such as the Down Syndrome Health Care

Guidelines, which are critical in helping to ensure that adequate attention is paid

to particular health care concerns. The challenge has been getting these resources

into the hands of those who need it the most. NDSS works closely with the Down

Syndrome Medical Interest Group, comprised of more than 150 physicians and clinicians worldwide who have an interest in working with this population, to share information and develop resources that will improve the quality of life for individuals

with Down syndrome.

Attached is a summary of Down Syndrome Health Care Guidelines, based on

Health Care Guidelines for Individuals with Down Syndrome: 1999 Revision (Down

Syndrome Preventive Medical Check List), published in Down Syndrome Quarterly

(Volume 4, Number 3, September, 1999, pp. 1–16).

CONCLUSION

The opportunities today for individuals with Down syndrome and mental retardation have never been greater, thanks to the commitment and dedication of many

legislators, organizations, families and agencies. In the past 25 years alone,

groundbreaking legislation has lead to de-institutionalization, inclusion in schools

and a no-tolerance attitude towards discrimination against people with disabilities.

Now that the laws are in place and the opportunities to succeed available, we owe

it to people with mental retardation to ensure they are healthy enough to take advantage of all that is available.

We appreciate your taking the time to read our testimony, and applaud you for

your interest in helping to improve health care for people with mental retardation.

Please do not hesitate to contact us if we may be of any assistance to you in your

efforts.

ATTACHMENT I—ADDRESSING THE HEALTH CARE NEEDS OF PEOPLE WITH DOWN

SYNDROME

The National Down Syndrome has been dedicated to improving health care for individuals with Down syndrome since its inception in 1979. Under the direction of

a Science Advisory Board and Clinical Advisory Board comprised of distinguished,

world-renowned experts on Down syndrome-related issues, NDSS has developed programs and resources to address these needs.

Science Scholar Award Program.—Each year NDSS awards research grants to

promising postdoctoral scientists who have demonstrated extraordinary skill and

achievement in seeking a better understanding of Down syndrome. Since 1983, more

than twenty researchers have received this prestigious salary grant.

Research Partnership.—NDSS, the National Institute of Child Health and Human

Development and the National Institute of Neurological Disorders and Stroke are

engaged in a $3.9 million partnership to further Down syndrome research. The

funding goes to organizations and individual researchers studying Down syndromespecific cognition, behavior and related therapies. The $3.9 million partnership represents the most funding ever earmarked for Down syndrome research.

International Down Syndrome Research Conference.—In an effort to increase communication among the world’s most distinguished scientists working in fields related to Down syndrome, NDSS hosts international scientific conferences on relevant research topics. The proceedings of these conferences are published and distributed worldwide.

Educational Services.—The NDSS Information and Referral Center responds to

over 25,000 requests annually via E-mail and toll-free hotline. A large percentage

of these requests are related to health care issues. NDSS has developed and disseminated a Clinical Care Booklet series to educate parents and professionals about

some of the most commonly occurring health care problems, including the Heart, the

Endocrine System, Neurology, Alternative Therapies, Speech and Language, and

others.

Changing Lives: Down Syndrome & the Health Care Professional Program.—This

new program, still in the pilot phase, is being developed to support health care professionals in the delivery of appropriate care and to help children with Down syndrome get the healthy start they deserve. The program aims to educate health care
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professionals in the community about Down syndrome and how best to treat and

diagnose these patients; educate health care professionals on the medical and developmental needs a baby with Down syndrome may have and the best care practices

to address these needs; provide health care professionals with materials and resources to share with new and expectant parents of children with Down syndrome;

and raise the awareness of health care professionals of how attitudes and beliefs affect the experience of raising a child with Down syndrome.

ATTACHMENT II—NDSS SCIENCE ADVISORY BOARD AND CLINICAL ADVISORY BOARD

SCIENCE ADVISORY BOARD

David Patterson, Ph.D., Chair, Eleanor Roosevelt Cancer Research Institute, CO;

Terry J. Hassold, Ph.D., Department of Genetics, Case Western Reserve University,

OH; Julie R. Korenberg, Ph.D., M.D., Department of Pediatrics, Cedars-Sinai Medical Center, CA; Ira T. Lott, M.D., Department of Pediatrics, Irvine Medical Center,

CA; and Lynn Nadel, Ph.D., Department of Psychology, University of Arizona, AZ.

CLINICAL ADVISORY BOARD

William I. Cohen, M.D., Chair, Down Syndrome Center of Western PA, Children’s

Hospital of Pittsburgh, PA; Joan E. Guthrie Medlen, R.D., Disability Solutions, OR;

Jon F. Miller, Ph.D., Waisman Mental Retardation Center, University of WisconsinMadison, WI; Bonnie Patterson, M.D., Cincinnati Center for Developmental Disorders, University of Cincinnati, OH; Richard A. Villa, Ed.D., Bayridge Consortium,

Inc., CA; Leslie Walker-Hirsch, M.Ed., Moonstone Group, NY; and Patricia C. Winders, PT, Down Syndrome Clinic, Kennedy Krieger Institute, MD.

ATTACHMENT III—SUMMARY OF DOWN SYNDROME HEALTH CARE GUIDELINES

(Based on Health Care Guidelines for Individuals with Down Syndrome: 1999 Revision, Down Syndrome Preventive Medical Check List, published in Down Syndrome Quarterly, Volume 4, Number 3, September, 1999, pp. 1–16)

DOWN SYNDROME—NEONATAL (BIRTH–1 MONTH)

Review parental concerns. Chromosomal karyotype; genetic counseling, if necessary.

If vomiting or absence of stools, check for gastrointestinal tract blockage (duodenal web or atresia, or Hirschsprung disease).

Evaluation by a pediatric cardiologist including echocardiogram. Subacute bacterial endocarditis prophylaxis—SBE, in susceptible children with cardiac disease.

Exam for plethora, thrombocytopenia.

Review feeding history to ensure adequate caloric intake.

Thyroid function test—check on results of state-mandated screening at birth.

Auditory brainstem response (ABR) or otoacoustic emission (OAE) test to assess

congenital sensorineural hearing (at birth or 3 months).

Pediatric ophthalmological evaluation (by 6 months) for screening purposes.

Discuss Early Intervention (infant stimulation) and refer for enrollment in local

program.

Refer to local DS parent group for family support and resources, as indicated.

Refer to NDSS.

DOWN SYNDROME—INFANT (1–12 MONTHS)

General neurological, neuromotor, and musculoskeletal examination.

TSH and T4—Thyroid Function Test (at 6 & 12 months).

Evaluation by a pediatric cardiologist including echocardiogram, if not done at

birth.

Consider progressive pulmonary hypertension in patients with a VSD or atrioventricular septal defect who are having little or no symptoms of heart failure.

Subacute bacterial endocarditis prophylaxis—SBE (as indicated).

Well Child Care—immunizations.

Feeding consult, especially if constipated. Consider Hirschsprung disease.

Auditory brainstem response (ABR) or otoacoustic emission (OAE) test to assess

congenital sensorineural hearing (by 3 months if not performed previously or if results are suspicious).

Ear, nose and throat exam (as needed), especially if suspicious of otitis media.

Vision exam (by 6 months & annually), earlier if nystagmus, strabismus or poor

vision.
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Discuss early intervention and refer for enrollment in local program (if not done

yet).

Application for SSI, depending on family income; consider estate planning/custody

arrangements; continue family support.

DOWN SYNDROME—CHILDHOOD (1–12 YEARS)

TSH and T4—Thyroid Function Test (annually).

Echocardiogram by a pediatric cardiologist if not done previously.

Behavioral Auditory Testing (every 6 months until age 3, annually thereafter).

Lateral cervical spine x-rays (neutral view, flexion, extension) to rule out atlantoaxial instability. Radiologist to measure atlanto-dens distance and neural canal

width (at 3–5 years, then as needed).

General pediatric and neurological exam including evaluation for signs of spinal

cord compression: deep tendon reflexes, gait, Babinski sign.

Use Down syndrome growth charts and head circumference charts, as well as

growth charts for typically developing children.

Eye examination (annually, or more often as indicated).

Screen for celiac disease IgA antiendomysium antibodies and total IgA (between

2–3 years).

Question about obstructive sleep apnea; ear, nose and throat exam (ENT) (as

needed).

Dental Exam (2 years; follow up exams every 6 months after). Twice daily teeth

brushing.

Reinforce need for subacute bacterial endocarditis prophylaxis (SBE) for cardiac

problems (as indicated).

Brief vulvar exam for girls.

Well Child Care—immunizations; administer pneumococcal vaccine (2 years).

Well balanced, high fiber diet. Regular exercise program.

Evaluation by a speech and language pathologist to maximize language development and verbal communication.

Review parental concerns; current level of functioning; monitor for behavior problems.

Complete educational assessment annually, as part of Individualized Family Service Plan (IFSP) for child from birth to 3 years of age, or Individualized Educational

Plan (IEP) from age 4 until the end of formal schooling.

Continue speech therapy and physical therapy (as needed).

DOWN SYNDROME—ADOLESCENCE (12–18 YEARS)

TSH and T4—Thyroid Function Test (annually).

Auditory Testing (annually).

Cervical spine x-ray, if required by Special Olympics.

Monitor for obstructive airway disease and sleep apnea.

General physical and neurological examination (check for atlanto-axial dislocation).

Eye examination (annually).

Dental Exams (every 6 months). Twice daily teeth brushing.

Monitor for obesity by plotting height for weight on the growth charts for typical

children.

Clinical evaluation of the heart to rule out mitral/aortic valve problems. Echocardiogram (ECHO) as indicated by clinical findings.

Reinforce the need for subacute bacterial endocarditis prophylaxis (SBE) in susceptible adolescents.

Adolescent medicine consult for puberty/sexuality issues; health, abuse prevention

and sexuality education. Pelvic exam (only if sexually active).

Low calorie, high fiber diet; regular exercise program.

Smoking, drug and alcohol education.

Psychoeducational evaluations (every two years), for Individualized Educational

Plan (IEP).

Begin functional transition planning (age 16 years).

Consider enrollment for SSI depending on family income; monitor independent

functioning.

Update estate planning and custody arrangements; discuss plans for alternative

long-term living arrangements such as community living arrangements.

DOWN SYNDROME—ADULTHOOD (OVER 18 YEARS)

TSH and T4—Thyroid Function Test (annually).

Auditory testing (every 2 years).
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Cervical spine x-rays as needed for Special Olympics participation (or as indicated).

Opthalmologic examination, looking especially for keratoconus and cataracts

(every 2 years).

Dental Exam (every 6 months). Twice daily teeth brushing.

Clinical evaluation of the heart to rule out mitral/aortic valve problems. Echocardiogram (ECHO) as indicated by clinical exam.

Reinforce need for subacute bacterial endocarditis prophylaxis (SBE) in susceptible adults with cardiac disease.

Baseline Mammography at 40 years. Follow up every other year until 50 years,

then annually.

Pap smear and pelvic exam (every 1–3 years following the age of first intercourse). If not sexually active, single-finger bimanual examination with finger-directed cytology exam. If unable to perform, screen pelvic ultrasound (every 2–3

years). Breast exam (annually).

General physical/neurological exam (atlanto-axial dislocation); routine adult

health care.

Clinical evaluation for sleep apnea.

Low calorie, high fiber diet. Regular exercise. Monitor for obesity.

Health, abuse prevention & sexuality education.

Smoking, drug and alcohol education.

Clinical evaluation of functional abilities (consider accelerated aging); monitor loss

of independent living skills.

Neurological referral for early symptoms of dementia (decline in function, memory

loss, ataxia, seizures and incontinence of urine and/or stool).

Monitor for behavioral/emotional changes, mental health. Psych Referral (as needed).

Continue speech and language therapy, as indicated.

Discuss plans for programming/vocational opportunities at age 21 or end of formal

schooling.

Discuss alternative long-term living arrangements; estate planning/custody arrangements.

PREPARED STATEMENT OF THE NATIONAL MARFAN FOUNDATION

Chairman Specter and members of the Committee, the members of the National

Marfan Foundation (NMF) thank you for the opportunity to provide written testimony in support of the budget of the National Institutes of Health (NIH) and the

National Institute of Arthritis, Musculosketetal and Skin Diseases (NIAMS). This

is the first year that the NMF is submitting written testimony on its own. We have

been previously included in the written and spoken testimony of the Coalition for

Heritable Disorders of Connective Tissue (CHDCT). We would first like to express

our gratitude of the Committee’s ongoing support of NIH research, and most particularly their support for increased funding for research on rare and genetic disorders—research that might not otherwise have been funded.

The NMF believes that we must sustain the current level of commitment to the

NIH. The NMF joins the Ad Hoc Group for Medical Research Funding, the Coalition

of Heritable Disorders of Connective Tissue, the NIAMS Coalition, and the Coalition

of Patient Advocates for Skin Disease Research in asking that Congress support a

16.5 percent increase in the budget of the NIH for fiscal year 2002. This increase

would allow us to get back on track the bipartisan effort to double the NIH budget

by fiscal year 2003—a sentiment shared by the President, the Congress and the

American people.

The Marfan syndrome is a potentially fatal, relatively rare genetic disorder of the

connective tissue. The NMF requests the establishment and support of Scientific Research Centers for Marfan Syndrome and Related Disorders which will allow these

centers to gather significant numbers of Marfan affected people to investigate clinical therapies, which in the case of a rare and multi-system disorder, are the only

way to compile enough individuals to establish well-controlled clinical studies. This

can bring about a comprehensive understanding of the clinical burden of this syndrome and help to predict manifestations of the disease before they occur. In addition, the recruitment of geneticists, molecular and cell biologists who can contribute

their expertise to a common problem, serve to coordinate basic research and enable

these studies to be translated rapidly into advances in patient care. The goal of establishing Scientific Research Centers for the Marfan Syndrome and Related Disorders can only be accomplished through the available mechanisms of the National

Institutes of Health.
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The NMF represents people affected with the Marfan syndrome. Voluntary health

organizations such as ours consistently hear the frustrations, confusion and despair

of people who deal with the daily medical issues associated with genetic disorders.

In multi-systemic disorders such as Marfan syndrome, numerous physicians in specialties such as cardiology and cardiovascular surgery, orthopedics, ophthalmology,

respiratory/pulmonary, neurology, and genetics must be consulted to manage the

manifestations of this syndrome. The families are distraught from the overwhelming

emotional turmoil of dealing with so many doctors and the fear of losing 2 their life

at an early age, not to mention the tremendous monetary burden. These circumstances are multiplied many times over since this genetic disorder can affect

more than one family member and more than one generation.

It is estimated that a quarter of a million people in the United States are affected

by the Marfan syndrome and relate disorders. The Marfan syndrome is a potentially

fatal, genetic disorder of the connective tissue. The Marfan syndrome is a multi-system disorder because the connective tissue is essentially the glue and the scaffolding

of the body, and manifests itself in the heart, eyes, skeleton and blood vessels. Individuals with the Marfan syndrome are uncharacteristically tall, with arms, legs,

toes and fingers that are disproportionately long and thin. Typically, patients also

have poorly developed muscles and abnormally curved spines.

The life-threatening aspect of this disorder is the weakening of the aorta, the largest artery that supplies blood to the heart. In the Marfan syndrome, the abnormalities in the connective tissue place a great deal of stress on the aortic artery and

significantly weaken the walls of this most important blood vessel. Tears form in

the walls of the aorta and death can only be prevented by surgical intervention.

There is no simple diagnosis for the Marfan syndrome. Many patients who present

in emergency rooms fail to receive life-saving treatments. For example Jonathon

Larson, the Tony awardwinning playwright of the hit Broadway musical ‘‘Rent’’,

died at the age of 35 after being misdiagnosed by two different hospital emergency

rooms. In addition, communities across this country often are faced with the premature death of a future basketball star or athlete, because parents, coaches, and

physicians failed to realize that their height, a tremendous asset on the basketball

court or other athletic arena was in reality a sign of the Marfan syndrome. This

was unfortunately the case for Flo Hyman, the captain of the 1984 U.S. Olympic

Women’s Volleyball Team. She was not diagnosed with the Marfan syndrome until

after her death from aortic dissection at the age of 31 on the volleyball court. Similar scenarios are noted in many cases. A woman who lost a brother, a sister and

a son to the Marfan syndrome remembers how she learned about the disorder, ‘‘It

was the first day of school for my three excited sons and the bus was just minutes

from arriving. Suddenly my son fell to the ground in convulsions and extreme pain.

It took the hospital 28 hours to determine the problema four-foot long tear in his

aorta . . .’’ It is stories such as these that move us to advocate for this Committee’s

support for increased research funding. Research is the only hope for Marfan-affected individuals.

To this day ignorance still exists on how to adequately diagnose the Marfan syndrome. Many people die at a young age in the emergency room with a ruptured

aorta because these people were never diagnosed. One of the main problems is that

there is no simple diagnostic test for this multi-system disorder. Because most features of the Marfan syndrome progress with age, the diagnosis is often more obvious

in older persons however, this can turn out to be deadly. Furthermore, those persons who are considered to be candidates of this syndrome but cannot get a precise

diagnosis must also continually monitor themselves since the 3 symptoms manifest

over time. Research is desperately needed in this area. Development of a rapid molecular diagnostic test could save thousand of lives.

Research into the basic mechanisms of the Marfan syndrome has borne fruit. In

1991, scientists discovered the cause of the Marfan syndrome, an alteration of the

gene that encodes the protein fibrillin-1. Although this important finding did not

lead us directly to a cure, it has allowed scientists to focus their research to look

for answers to more specific questions. More research is needed to determine how

this mutant gene actually produces the change in human biology that leads to this

disease and is responsible for variability within the syndrome from mild to extremely severe cases. Additional basic research in molecular studies will also help

us to fully investigate the interaction of the fibrillin-1 gene product with other molecules in the extracellular matrix to better understand pathogenesis of this disease.

The use of this knowledge to develop a genetic manipulation strategy to eventually

cure this disease is becoming technically feasible but is years away. In the meantime, more immediate issues need to be dealt with.

Clinical research is needed to identify strategies and therapies for reducing aortic

enlargement, to determine the optimal time for surgical intervention and to predict
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risk for aortic dissection. This is extremely important to save lives as noted in a

recent letter to the NMF. A young woman writes ‘‘My cousin’s 17 year-old daughter

died with a ruptured aortic aneurysm. She knew she had Marfan syndrome and had

echocardiograms every six months. Her aorta was not large enough for surgery but

she must have not read the book, because she died anyway. She had an echocardiogram just six weeks before she died.’’ It is stories such as these that alert us to the

fact that much more research is needed in this most crucial area. It is imperative

to determine what are the clinical features and presentations of acute aortic dissection in Marfan patients and how is this different from non-Marfan patients.

Clinical research can also offer more solutions to be used immediately to alleviate

some of the pain and disabling effects such as curvature of the spine, dislocated

lenses in the eye, and abnormalities in the heart valves. Clinical research of treatments for back pain due to scoliosis and more specifically for dural ectasia, the enlargement of the membrane that surrounds the brain and spinal cord, are desperately needed to reduce the amount of pain and suffering endured by Marfan-affected individuals.

Funding biomedical research through the NIH is today’s investment in America’s

future. The technology and the science are available to understand and ultimately

cure or eradicate many of these devastating genetic disorders. Support for the NIH

is especially crucial to unlocking the mysteries of rare diseases, such as the Marfan

syndrome. We need your support.

PREPARED STATEMENT OF THE NATIONAL MEDICAL ASSOCIATION

Mr. Chairman and members of the Subcommittee, thank you for the opportunity

to present the views of the National Medical Association (NMA). I am Dr. Rodney

Hood, President of the NMA, and a practicing internist in San Diego, CA.

I am very pleased to have the opportunity to submit NMA’s fiscal year 2002 appropriations priorities to this Subcommittee. Established in 1895, the National Medical Association is the Nation’s largest and oldest professional, educational and scientific organization representing the interests of more than 26,000 African American physicians and their patients, as well as nearly 100 state and local societies.

As such, the NMA has been committed to improving the health status and outcomes

of minority and disadvantaged people for more than 105 years. And while the Association has focused primarily on health issues related to African Americans and

medically underserved populations, NMA’s principles, goals and initiatives benefit

all people.

As the leading force for parity and justice in medicine and the elimination of disparities in health, the NMA’s primary goals include improving the health status and

health outcomes of minorities. In our quest to improve healthcare, we have promoted the increased representation of African Americans and other underrepresented minorities in the health professions; the integration of hospitals and universities; the protection of the rights of our patients involved in—and increased participation in—biomedical research and the promotion of increased access to health

care services for all Americans.

In recent years, there have been considerable discussions about eliminating the

health disparities that pervade our nation’s minority populations, to the extent that

there are now national initiatives to close the gap. In order to understand the critical need to provide increased federal funding for programs established to address

the health status of African Americans and other medically underserved populations, it is important to know that centuries of discrimination against African

Americans have left us with a complicated legacy of poor health outcomes, illness,

disease and death that are widespread and pervasive. This is what authors W. Michael Byrd, M.D., M.P.H. and Linda A. Clayton, M.D., M.P.H. call the Slave Health

Deficit. The programs supported by this Subcommittee are critical to the elimination

of health disparities. NMA looks forward to working closely with the Subcommittee

and relevant federal agencies to ensure that the tremendous advances made

through biomedical research, health professions training and community based public health and disease control are equally available to all Americans, particularly

those who have not fully benefited from these advances.

SUPPORT THE DEVELOPMENT OF A HEALTH POLICY AND RESEARCH INSTITUTE

Recently, NMA joined the Office of the U.S. Surgeon General and the American

Public Health Association, in partnership with the nation’s leading health providers

and business leaders, to issue a Call to the Nation to Eliminate Racial and Ethnic

Health Disparities. In response to this challenge, the National Medical Association

urges Congress to provide $1 million to support the development and implementa-
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tion of a Health Policy and Research Institute focused on achieving health parity

for African Americans. NMA is concerned that historic and current data points to

a modern-day form of ‘‘health care racial profiling’’ that must be addressed if we are

ever going to achieve parity in health care. Recent studies are confirming what minority—particularly African American—physicians, health professionals and caregivers have known for years: there are significant disparities in the quality of

healthcare provided to minority patients across this nation. In addition, there are

disparities in training and professional advancement opportunities for minority

medical students and professors of medicine; and in opportunities for equitable participation by minority physicians in the managed care system. NMA strongly believes that without achieving parity in the health status of African Americans, who

experience disproportionate rates of disease, morbidity and mortality, the goals of

the U.S. Surgeon General’s Healthy People 2010 Initiative will remain unattainable.

NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES, NIH

Mr. Chairman, the disparate health status experienced by African Americans and

other minorities is a serious problem that threatens to increase in complexity as the

Nation, with its growing minority population, proceeds through the 21st century.

The long-term prognosis for the elimination of health disparities among minorities

is largely dependent upon a strong federal commitment to biomedical research and

research training. However, in order to fully realize the benefits of scientific investigation, research and research training, much more needs to be done by the National Institutes of Health (NIH) and policy makers to ensure that those who are

suffering disproportionately, with chronic and debilitating diseases, are able to

share in these advances.

NMA is pleased that Congress supported the elevation of the Office of Research

on Minority Health at NIH to Center status, during the 107th Congress. This effort

is critical to the Nation’s ability to effectively address the disproportionate cancer,

and other disease, mortality rates that exist among minorities and the underserved.

This Center will enable NIH to ensure that research targeted towards minorities is

carefully and strategically coordinated across the Institutes and provide increased

support for important minority focused biomedical research projects. Additionally,

the Center will help NIH to address the, often systematic, oversight of minorities

in clinical trials.

NMA supports fiscal year 2002 budget increase of $3.4 billion (16.5 percent above

the fiscal year 2001 funding level), for the National Institutes of Health, to keep us

on the path toward doubling the NIH budget by fiscal year 2003. NMA sincerely

hopes that as increased funding is made available to NIH, Congress will provide

adequate funding specifically targeted towards programs to improve the status of

minority health. NMA recommends that the National Center for Minority Health

and Health Disparities be funded at a level adequate to support the Center’s expanded agenda as well as the broadened populations it serves.

Funded at an estimated $130 million, in fiscal year 2001, more than $90 million

of the Center’s budget is identified to support specific, longitudinal research efforts

and programs. That provides very little latitude with which the Center can sufficiently support new or expanded functions, such as Research Endowments, Centers

of Excellence and the Loan Repayment program.

Now that there is a greater recognition of the need to make improving the health

status of minority Americans a national priority, the NMA is asking this Subcommittee to make the same commitment to minority health research.

HEALTH PROFESSIONS TRAINING THROUGH THE HEALTH RESOURCES AND SERVICES

ADMINISTRATION (HRSA)

The NMA strongly urges the Subcommittee to substantially provide increased

funding for Health Professions Training Programs at HRSA and supports the

Health Professions and Nursing Education Coalition’s recommendation of at least

$440 million for Title VII and VIII, of the Public Health Service Act, in fiscal year

2002. Each one of the Health Professions Training Programs, including the Training

for Diversity Programs, impact minorities, and other Americans, who reside in

Health Professions Shortage Areas (HPSA’s) where there are shortages of both primary care and specialist physicians. Funding cuts to these programs will negatively

impact the ability of minorities to pursue careers in health, as well as the patients

who benefit from their training.

Nearly all of the Health Professions Training Programs fund a variety of programs that are essential for students and institutions that work to improve the racial and ethnic diversity of the health professions workforce. These programs ensure

that all Americans, regardless of their race or geographic location, have access to
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quality health care services. Narrowing the health status gap that exists between

minorities and non-minorities is a national priority. Thus, increasing the numbers

of minorities in the health professions training pipeline, as well as those serving in

the health professions, is absolutely critical to accomplishing this goal.

Numerous responsible studies demonstrate that, historically, African Americans

and other minorities are more likely than their non-minority counterparts to serve

in medically underserved areas. However, while African-Americans represent approximately 12 percent of the U.S. population, they represent only 2–3 percent of

the Nation’s medical professionals.

Mr. Chairman, this Subcommittee has always been a strong supporter of the

Health Professions Training Programs. Your continued support is vital to ensuring

that bright, capable minority students who want to pursue careers in the health

professions have that opportunity, despite the looming financial burdens and matriculation challenges. We appreciate and recognize all that you have done for health

professions training in the past and urge you to be even more ardent supporters in

fiscal year 2002.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) RACIAL AND ETHNIC HEALTH

DISPARITIES INITIATIVE

The National Medical Association strongly supports increased funding for the

DHHS initiative to reduce racial and ethnic disparities in health [Racial and Ethnic

Approaches to Community Health (REACH) Initiative]. Studies clearly indicate that

there is a connection between race and ethnicity and the growing health disparities

and disease burden among African Americans and other underserved racial and ethnic minorities. With the Nation’s changing demographics, it is anticipated that minorities will comprise nearly 50 percent of the United States population during the

21st Century. Increased support of this initiative is critical to the future health of

this nation and its workforce.

Currently funded at $35 million, the REACH Initiative must be funded at a level

that will allow the CDC, in collaboration with OMH and other appropriate federal

agencies, to intensify its efforts to eliminate health disparities by funding additional

communities for Phase I planning grants, Phase II comprehensive grants, training

activities under national and regional minority organizations, expanded and enhanced technical assistance, research on social and behavioral determinants, distance-based training, effective health interventions and targeted health outcomes.

Additionally, in recognition of the strengths that national/multi-geographical minority organizations can provide this program, NMA urges the Committee to request

that DHHS include such organizations among the entities that are eligible to compete for funding without preventing other applicants from receiving these grants.

Such organizations often have the capacity to influence communities through coalitions and collaborative relationships that have already been established and provide

essential support to local organizations that may lack the infrastructure needed to

implement the full scale of programmatic activities required for this important program.

The REACH Initiative is critical to enhancing efforts geared towards disease prevention, health promotion and the delivery of care to racial and ethnic minorities.

Adequate support of this critical program will enable us to gain a better understanding of the relationship between race and ethnicity and health status, thereby

giving us tools that will help us to eliminate health disparities. The development

of close working relationships with minority communities is critical to ensuring that

programmatic implementation strategies and activities, such as data collection, are

culturally sensitive and appropriate.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) OFFICE OF MINORITY HEALTH

(OMH)

NMA was pleased that, for fiscal year 2001, Congress provided $50 million in

funding for the Office of Minority Health. However, given the additional demands

the DHHS Health Disparities Initiative has placed on this office, such funding remains inadequate to meet the programmatic needs of the Office. NMA strongly supports providing adequate funding for OMH to ensure continued support for the Office’s current programs as well as the expansion of its critical efforts. Significantly

more support is needed to allow OMH to accomplish the goals established by the

Health Disparities Initiative.

STUDY ON ETHNIC BIAS IN MEDICINE

Mr. Chairman, during fiscal year 2000, Congress commissioned an Institute of

Medicine (IOM) Study on ‘‘Ethnic Bias in Medicine.’’ This study will help provide
631

a clear understanding of the extent to which ethnic bias is ingrained in the practice

of medicine and the education of health professions students. Such knowledge is absolutely essential to the effort to eliminate health disparities by 2010. NMA recommends the Subcommittee request that the Institute of Medicine report back to

the Committee regarding the findings and recommendations of the study, upon its

completion, and urges the Committee to convene a hearing to address this important study.

HEALTH CARE INITIATIVE FOR THE UNINSURED

In order to provide medical care to the estimated 46 million uninsured Americans,

physicians and other health care providers, who provide this care, must often waive

payment or provide care on a reduced basis to the uninsured. In fact, studies show

that minority physicians provide disproportionate levels of care for the uninsured.

At the same time, the number of uninsured workers has increased and changes in

managed care have led to reduced Medicaid revenues. The NMA is concerned about

ensuring that uninsured Americans receive health care coverage and that physicians are able to receive an equitable reimbursement for their services. Therefore,

we strongly urge the Subcommittee to provide adequate support for this much-needed initiative to strengthen health services for uninsured workers. This initiative will

provide grants, over five years, to strengthen the ability of public and private entities, in 100 communities, to provide comprehensive care and coordinate health care

for uninsured workers.

MINORITY HIV/AIDS INITIATIVE

While new treatment therapies have led to the recent decline in HIV/AIDS death

rates, African Americans continue to die from this disease at disproportionate rates.

In fact, recent data from the Centers for Disease Control and Prevention shows that

AIDS is the number one killer of African American men between the ages of 25 and

44 and the second leading cause of death among African American women of the

same age. And, while Blacks and Hispanics accounted for 65 percent of AIDS cases,

estimates indicate that by the year 2005, Blacks will account for 60 percent of all

AIDS cases.

Mr. Chairman, the data paints a clear picture of the devastation HIV/AIDS has

brought to minority communities. The NMA thanks the Committee for its support

of the Minority HIV/AIDS initiative during the fiscal year 2001 funding cycle and

recommends full funding in fiscal year 2002 funding for this critical initiative to address HIV/AIDS across the nation’s racial and ethnic minority communities. The Minority AIDS initiative is in the early stages of implementation. Funding for this program needs to be increased to a level that will sustain and expand its current efforts. This program’s infrastructure and capacity to address disparities in AIDS

must be strengthened.

HEALTHY PEOPLE 2010

The National Medical Association views the Healthy People 2010 initiative as one

of great importance. Healthy People 2010 is to be commended for making the health

objectives identical for all Americans, rather than having different (generally lower)

targets for minorities as was the case for the Healthy People 2000 initiative. The

NMA strongly believes that all health status targets should be the same for all

Americans. We urge the Subcommittee to continue to provide the necessary resources to the Department of Health and Human Services to fund this important

initiative.

IN CLOSING

Mr. Chairman, thank you for the opportunity to present the views of the National

Medical Association. I am pleased to respond to any questions that you have. Our

Association looks forward to working with this Subcommittee to address the challenges we have outlined for you today.

PREPARED STATEMENT OF THE NATIONAL MPS SOCIETY INC.

Mr. Chairman and members of the Subcommittee: My name is Les Sheaffer, I

serve on the Board of Directors of the National MPS Society and chair the Committee on Federal Legislation. My daughter Brittany is 8 years old and is suffering

with MPS III. I have submitted this testimony to express the views of the National

MPS Society regarding the budget of the National Institutes of Health.
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I wish to offer my thanks to Chairman Specter and the members of the Subcommittee for their continued support for genetic and biomedical research through

the National Institutes of Health.

The Mucopolysaccharidosis disorders are relatively rare genetically determined

disorders caused by the body’s inability to produce certain enzymes. The lack of production of these vital enzymes results in the interruption of the usual breakdown

of specific normal molecules, which are then stored in every cell in the body. Storage

causes progressive damage including respiratory system, bones, internal organs,

nervous system and brain damage. The most profound effect of these disorders is

the poor quality of life these children eventually endure and a drastically shortened

life span. These disorders manifest themselves in children sometimes at birth and

develop more rapidly with age as cells become more damaged by storage.

The MPS disorders are inherited when both parents are carriers of a recessive

gene that causes enzyme deficiency in the child. The parents maintain a 1 in 4

chance of producing a MPS child with each pregnancy. The exception is MPSII in

which the mother may be the carrier and normally only boys are affected. The occurrence of MPS in the general population is believed to be 1 in 25,000 births.

There are eight types of MPS disorders; Huler Syndrome MPS IH, Scheie Syndrome MPS IS, Huler/Scheie Syndrome MPS IHS, Hunter Syndrome MPS II,

Sanfilippo Syndrome MPS III, Morquio Syndrome MPS IV, Maroteaux-Lamy Syndrome MPSVI, and Sly Syndrome MPS VII. All MPS disorders result in some combination of the affects listed above.

NIH funded research is a cornerstone component in the effort to develop treatments for these deadly diseases. The grants funded by NIH have resulted in a great

deal of important information that is integral in the quest for viable treatments for

the MPS disorders. There is no question that NIH appropriations for genetic and

biomedical research are truly an investment of federal funds.

NIH supported grants relating to MPS over the past few years have included:

bone marrow therapy, animal models, gene therapy, enzyme therapy, molecular

studies, stem cell research and other studies. Through the support of the NIDDK,

NINDS and NICHD these projects are contributing to a better understanding of

MPS disorders as well as narrowing down possible viable treatment options for

MPS. There is still much work to be done, with adequate funding this important

work can continue.

The 14.2 percent increase for NIH in the fiscal year 2001 appropriations bill will

continue to provide the essential federal funds for future advancements. I truly hope

that this commitment continues to hold the highest priority.

Expanded research in MPS disorders is a goal of our organization however we understand the value of basic and clinical research leading to advances in treatments

for all disease sufferers. It is also my view that legislation and funding for programs

supporting pediatric research grant programs, collaborative research in NIH institutes, increased access to clinical trials, training of pediatric research professionals

and multidisciplinary research and other enhancements will contribute to conquering many crippling diseases.

The National MPS Society represents hundreds of children with MPS and their

families across the United States. The support of Congress for genetic and biomedical research is greatly appreciated, without this support we could not hope to

find treatments for MPS and the many other disorders that plague thousands of

American children.

PREPARED STATEMENT OF THE NATIONAL MULTIPLE SCLEROSIS SOCIETY

Mr. Chairman and distinguished members of the subcommittee, we appreciate the

opportunity to submit written testimony on behalf of the National Multiple Sclerosis

Society. The Society is the world’s largest private voluntary health agency devoted

to the concerns of all those affected by MS. Throughout the Society’s 55-year history,

our number one priority has been research to understand MS and apply this knowledge to the development of new treatments and a cure. Our current annual budget

for research is nearly $30 million. This represents the largest privately funded program of basic, applied and clinical research and training related to multiple sclerosis

in the world.

In this statement, we wish to emphasize the importance of NIH basic and clinical

research to all people with chronic illnesses and disabilities and highlight our solid

working relationship with NIH. Indeed, NIH and the National MS Society collaborate to further biomedical research and to end the devastating effects of MS. The

most recent example is the first-ever collaborative research effort between the NIH

and the National MS Society, supporting a multi-year research effort on gender and
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sex-based differences between men and women with MS and other autoimmune diseases. This effort, focused primarily at the NIAID, serves as an outstanding model

for future collaborations between the Society and NIH, which we welcome and look

forward to.

MS is a progressive, degenerative and disabling disease of the central nervous

system, unpredictable in its course, and devastating in its effects. It affects a third

of a million Americans and their families, friends and employers. It can cause spasticity, tremor, abnormal fatigue, bladder and bowel dysfunction, cognitive problems,

visual problems, mobility impairment, and in the worst cases, complete paralysis

and blindness. The disease usually is diagnosed between the ages of 20 and 40—

but is life long. Many people with MS live thirty years or more with constant unpredictability and progressive disability. MS affects more than twice as many women

as men, can result in loss of employment and loss of a place in society and the community. Recent studies sponsored by the National MS Society show that the annual

direct and indirect cost of the disease for each affected individual as a result of MS

averages $44,000—and the total cost can exceed $2.6 million over an individual’s

lifetime. For all people with MS in the United States, the annual cost exceeds $13

billion. Ending the devastating effects of this unpredictable disease is completely dependent upon the discovery of safe and effective treatments that halt progression

of the disease and reverse its symptoms.

RECENT INSTITUTE OF MEDICINE REVIEW OF CURRENT KNOWLEDGE OF MS

In April 1999, the National MS Society’s Board of Directors commissioned the National Academy of Sciences/Institute of Medicine (IOM) to undertake a strategic

analysis of the current state of knowledge of multiple sclerosis and to evaluate strategies for future productive basic and clinical research. The Board commissioned the

$1.2 million study in the hope it would identify promising areas of research and

other strategies that had not previously been exploited, not just for the National MS

Society, but for all agencies and pharmaceutical companies engaged in the battle

against MS around the world.

The IOM assembled a committee of 14 independent scientists and physicians from

basic and clinical academic research and from industry, with expertise in many different fields of science and medicine. Over the course of 18 months, the committee

reviewed the therapeutic frontiers and quality of life issues, and sought comments

from 45 outside consultants. A draft report was prepared, and was reviewed by experts from outside the MS Society.

While underscoring the quality of current MS research worldwide and the

progress that has been made, the committee made 18 recommendations that fall

into three categories: research on the cause, course and treatment of MS; disease

adaptation and management; and building and supporting the MS research ‘‘enterprise’’ (the training and infrastructure to attract and keep the best minds focused

on the problem of MS). Many are strategies already being employed through existing research programs at the National MS Society as well as through research programs related to MS supported by government agencies, including NIH, and other

MS societies around the world.

Recommendations for Research on Causes, Course, and Treatments:

—Research the pathological changes underlying the natural course of MS.

—Investigate how nerve cells are damaged, how that damage can be prevented,

and role of glial cells (such as oligodendrocytes and astrocytes) in damage and

repair.

—Identify the genes that make people susceptible to developing MS.

—Search for a possible pathogen or pathogens that trigger MS.

—Exploit the power of neuroimaging technology (such as MRI and related technologies).

—Continue to investigate the immune system events that lead to MS.

—Develop animal models that better reflect the features of MS.

—Find strategies to protect and repair neurons and oligodendrocytes, including

research into stem cells.

—Investigate more effective ways to manage troubling symptoms of MS.

—Research the effectiveness of combination therapies.

—Develop better strategies to gain the most scientific value from clinical trials.

Recommendations on Disease Adaptation and Management:

—Develop better tools for assessing the health status of individuals with MS to

increase the reliability and power of clinical trials and to improve individual patient care.

—Find ways to improve the ability of those with MS to function and adapt, and

determine the most pressing needs of people with MS.
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Recommendations on Building and Supporting the MS Research Enterprise:

—Recruit new researchers to work in MS, including those from allied fields.

—Stimulate collaborations between scientists from different disciplines.

—Stimulate large-scale, expensive, collaborative studies.

—Increase cross-disciplinary research on ‘‘quality of life’’ issues.

—Organize research to more rapidly assess claims for new candidate MS pathogens.

The National MS Society’s Research Programs Advisory Committee is thoroughly

reviewing the report and will, for our own programs, prioritize the recommendations

that have been made, taking into account work already being done, and develop

strategies for implementing new programs, where appropriate.

To help disseminate the study’s results and plan for the future, the National MS

Society also has asked the NAS/IOM to host, at the Society’s expense, a conference

in April 2001 that will bring together organizations from around the world that fund

MS research. The aim is to maximize the dissemination of information in the IOM

report, to stimulate discussion about important strategies that might be implemented, and to foster collaborations, where possible, in support of MS research. NIH

program officers involved in institutes that support work related to MS will be in

attendance, and it will be an opportunity to work toward a coherent, inter-organizational effort to further MS research.

While the IOM study will be an important reference point for the development

of future strategies in MS research, it also clearly illustrates, through the example

of MS, the need to continue the course of doubling NIH funding over five years (fiscal years 1999–2003).

—MS is an extremely complex disease with no known pathogen or known determinants of its severity and course, and as a consequence, increased understanding of the cause and treatments require research on many fronts. MS is

not alone in this regard. Neurological diseases are among the most difficult to

study. Although beneficial therapies have been developed in the last decades for

Parkinsons’s disease, Epilepsy, and more recently for Alzheimers’ disease, there

is still no cure for any of the degenerative neurological diseases.

—Advances, such as improved ability to create images of the living brain and spinal cord, new understanding of the brain’s capacity for repair, and the overall

accelerated pace of new discoveries about the cellular machinery of the brain,

have renewed the optimism of many investigators about the possibility of developing effective therapeutic strategies for MS and other disorders.

—On the horizon are important new therapeutic strategies: gene therapy, stem

cell transplantation and neuroprotection. Much needs to be done in these areas,

but progress in understanding and treating virtually all degenerative neurological diseases depends on our ability to capitalize on such new research dimensions.

THE NATIONAL MULTIPLE SCLEROSIS SOCIETY AND THE NATIONAL INSTITUTES OF

HEALTH

National Institute of Neurological Disorders and Stroke

The National MS Society has had a long and productive relationship with NIH,

particularly with the National Institute of Neurological Disorders and Stroke

(NINDS). Our founder, Ms. Sylvia Lawry, who passed away on February 24, 2001,

helped spearhead the effort that led to the creation of what is now the NINDS at

NIH in 1950 when President Truman signed the bill into law that established the

former National Institute for Neurological Diseases and Blindness. Since then, the

Society has had a very positive working relationship with the institute—a vital link

for us since NINDS currently is responsible for approximately 75 percent of the MSrelated research at NIH.

The Society works with NINDS to coordinate grant funding. In cases where scientists seek support for projects from both NINDS and the Society, we have had

fruitful negotiations with the agency to assure appropriate levels of funding, without

overlapping support.

Intramural scientists from NINDS serve on our scientific advisory committees and

help the Society make our research project decisions. These outstanding scientist/

physicians dedicate their volunteer time to help the Society make its research funding decisions, and to help ensure that the work of the Society and that of relevant

parts of NIH are in concert, and not in opposition.

National Institute of Allergy and Infectious Diseases

While MS is a neurological disease, the root problem in MS is dysfunction of the

immune system. Therefore, the Society fosters close working relationships with the
635

primary institute charged with studies of the immune system, the National Institute

of Allergy and Infectious Diseases (NIAID). NIAID funds about 25 percent of the

MS-related research at NIH. The Society benefits from a variety of interactions with

NIAID. We have participated in the NIH Autoimmune Disease Coordinating Committee that is assessing federal and non-federal support of autoimmune disease research and is charged with plotting a dynamic future research plan.

But perhaps the most significant aspect of our relationship with NIAID is the

first-ever collaborative initiative to fund research on ‘‘Sex-based Differences in the

Immune Response.’’ This collaboration extends the reach of the Society’s targeted

research initiative on gender differences in MS by encouraging basic and clinical investigation of sex differences in the immune response in MS and related diseases;

forging new collaborations to address existing gaps; providing wider visibility of the

problem and opportunities; and ensuring increased support for high quality and relevant research.

—The objectives are to identify and define differences in immune response between males and females to increase understanding and treatment of immunebased diseases such as MS.

—The Society and NIAID will co-fund research projects relevant to MS, but the

program also will fund projects related to other autoimmune diseases. —Over the course of this agreement, up to $20 million could be spent on this ini- tiative, of which the Society plans to contribute up to $4 million.

—A Request for Applications (RFA) has been released, and the deadline is August

2001.

NIH FUNDING RECOMMENDATIONS

NIH plays the major role in maintaining our country’s preeminence in biotechnology and provides worldwide leadership in health research and discovery. The

National MS Society recognizes that new discoveries and breakthroughs could come

from any area of biomedical research and could apply to the primary concern of our

members: finding new treatments and eventually a cure for MS. Therefore we encourage Congress to focus on NIH as a whole and on agencies of particular relevance to our concern, knowing that a well-funded federal research enterprise will

be of great public benefit.

We would like to express our sincere appreciation, Mr. Chairman, for the work

this subcommittee has done in the past to promote biomedical research funding. The

National Multiple Sclerosis Society believes that in order to take advantage of current opportunities in biomedical and rehabilitation research, Congress must increase funding at NIH by 16.5 percent for fiscal year 2002. This would keep us on

track, and bring us another year closer, to our goal of doubling the NIH budget over

the five-year period fiscal years 1999–2003. In order to pursue cutting edge research, the Society recommends that this translate into parallel increases of 16.5

percent each for the National Institute of Neurological Disorders and Stroke and the

National Institute of Allergy and Infectious Diseases, the primary institutes that

conduct nearly all of the MS-related research at NIH.

NEUROSCIENCE CENTER

Last year, Congress approved $47.3 million in funding to begin the construction

of the John Edward Porter Neuroscience Center at NIH. This year, the National MS

Society asks that Congress provide $26 million to complete Phase I and $10.6 million to start Phase II of construction. The Center will emphasize important cross

cutting themes such as neurodegeneration, regeneration and repair of neurons,

neurogenetics and pain research. Last year’s funding for the Center was incorporated into the NIH Building and Facilities budget, and did not affect funding for

research. Likewise, second-year funding for the Center should come out of the same

budget. Funding for the Porter Neuroscience Center would continue to increase the

pace of discovery in all areas of neuroscience and help translate laboratory discoveries into new and effective treatments.

SUMMARY

The National MS Society recognizes that new discoveries and breakthrough findings could come from almost any area of biomedical research and could apply to the

primary concern of our members: finding a cure for MS. NIH plays the major role

in maintaining our country’s preeminence in the biotechnology industry and provides world-wide leadership in health research and discovery. We thus encourage

Congress to focus on NIH as a whole, and on agencies of particular relevance to our

concern, knowing that a well-funded federal research enterprise will benefit all of

us.
636

Increasing funding at NIH by 16.5 percent will fulfill our fourth annual objective

in the five-year effort to double the biomedical research budget at NIH. We also recommend parallel increases for the two institutes that conduct or fund the majority

of MS-related research at NIH: NINDS and NIAID. In addition, in order to take advantage of potential discoveries in all areas of neuroscience and help translate these

discoveries into new and effective treatments for patients, we recommend funding

the completion of the John Edward Porter Neuroscience Center at NIH. These priorities represent an extraordinarily good use of federal resources that will yield important biomedical and economic benefits.

PREPARED STATEMENT OF THE NATIONAL NEUROFIBROMATOSIS FOUNDATION, INC.

The National Neurofibromatosis Foundation, Inc. (NNFF) is an organization dedicated to improving the health and well-being of individuals and families affected by

neurofibromatosis otherwise known as ‘‘NF.’’ The Foundation is the oldest and by

far largest NF organization in the world. I have been privileged to serve as its President since 1986 and currently serve also as Chairman of the International

Neurofibromatosis Association.

NF is a neurological disorder that causes a variety of problems including learning

disabilities, skeletal abnormalities, disfigurement, deafness, blindness, loss of limbs,

and brain, spinal, and dermal tumors. It also can be fatal. NF does not discriminate.

It is found in every racial and ethnic group throughout the world and affects both

sexes equally.

Neurofibromatosis is a surprisingly common genetic disorder of the nervous system which causes tumors to grow along nerves anywhere on or in the body. In fact,

NF is the most common neurological disorder caused by a single gene. NF is more

prevalent than Cystic Fibrosis, hereditary muscular dystrophy, Huntington’s Disease, and Tay Sachs combined.

—Two distinct forms of NF exist. NF1 is the more familiar form of the disorder

and occurs in one out of every 4,000 births. At least 100,000 Americans of both

sexes and all races have the NF1 gene defect. NF2, which generally involves

more severe symptoms, occurs in one out of every 40,000 births.

—Symptoms of both forms of NF vary greatly but can include curvature of the

spine, enlarged heads, congenital bone defects, blindness, loss of limbs, and tumors of the optic nerves, the brain, and the spinal cord, as well as the vestibular nerves which may cause deafness.

—Recent advances in NF research have linked the disorder to cancer, brain tumors, heart disease, and learning disabilities. In particular, NF causes learning

disabilities at about four to five times the frequency found in the general population.

There is still no way to prevent NF and there is no known cure. But prior federal

funding has helped lead to important advances. Researchers are hopeful that a cure

can be found in the next 10–15 years and believe that this timeframe possibly could

be cut in half if more research dollars are made available. The potential that NF

research holds for cancer, developmental disorders, and learning disabilities is significant for the more than 100,000,000 Americans with these medical problems.

I am pleased and proud that NF research has been recognized as a model for

‘‘Managing Science.’’ It represents an effective partnership between public agencies,

most notably the U.S. Congress and the National Institutes of Health (NIH), private

organizations and The National Neurofibromatosis Foundation, Inc., and scientists

and clinical researchers in the field who have achieved tremendous progress by their

collaboration. NF also has a particularly strong and committed grassroots network

of individuals affected by NF and their families who are united in a common purpose to promote research and decrease the impact of neurofibromatosis.

NF research has been so productive that scientists have moved from cloning the

NF gene to the start of clinical trials within a single decade. Despite these successes, there is still a long way to go to find a cure. The next steps in the

neurofibromatosis research agenda include continuing work in basic research, preparing comprehensive natural history studies for NF, and maintaining the all-important process of clinical trials with innovative approaches. With these goals in

mind, our first priority continues to be directing limited resources to support research activities that will lead to better understanding, diagnosis, and treatment of

neurofibromatosis, and an enhanced quality of life for persons with the disorder.

Congress and the Administration have demonstrated their commitment to scientific advances in this field with funding and directives for improved coordination

at the National Institutes of Health. Funds have been appropriated since fiscal year

1996 as part of the Congressionally Directed Medical Research Programs (CDMRP)
637

1Scientific Opportunities and Public Needs, National Institutes of Health, 1998.

in the Department of Defense (DOD) to support neurofibromatosis research by making grants available to NF scientists worldwide through a meticulous peer review

process. CDMRP is a unique partnership among the public, Congress, and DOD to

mobilize resources and identify untapped opportunities for research that will shape

the future of health care in areas of tremendous need including women’s health,

osteoporosis, and prostate, breast, and ovarian cancer. It is a remarkable testament

to the leadership of our Armed Services. We have requested that a total of

$25,000,000 be appropriated in fiscal year 2002 under the Medical Advanced Technology account of the DOD Research, Development, Test, and Evaluation budget of

the U.S. Army for neurofibromatosis research.

CDMRP is the largest single source of funding for NF1 and NF2 research in the

world. But the support that we have received from other sources is also of great importance to the future well-being of individuals and families with NF. In its fiscal

year 2000 appropriations bill this Subcommittee added language which expressed to

the NIH the commitment of the full Committee and of the Congress to accelerate

research to find a cure for NF. NF research has wide-ranging impact beyond

neurofibromatosis. It has linked the disease to cancer, brain tumors, and developmental disorders. NF research has also documented the involvement of

neurofibromatosis in heart valve formation which may lead to new opportunities

and understanding of the genetic and environmental causes of heart disease. It has

demonstrated significant promise to uncovering a molecular basis for cognitive impairment and will have broad application to learning disabilities in the general population. This Subcommittee has recognized that the wide variety of symptoms of NF

and the significant potential that NF research has for other very large patient populations demands the continued integration of neurofibromatosis research with the

basic and clinical research goals of NIH.

Today, I’m asking that you continue to provide clear directives to the National Institutes of Health to express the continuing commitment of the Congress to NF research conducted at NIH, and to ensure that the level of funding to find a cure for

thousands of individuals with neurofibromatosis continues to grow every year. NF

has been a tremendous research success story for all of those who have invested in

it.

Mr. Chairman and Members of the Subcommittee, on behalf of The National

Neurofibromatosis Foundation, Inc., as well as the thousands of children and adults

with NF, I thank you for your support.

The National Neurofibromatosis Foundation, Inc., a non-profit organization, is the

leading resource on NF. NNFF’s primary goals are:

—To promote and drive research to find the cause(s) and cure for NF;

—To provide support to patients and their families;

—To promote public awareness and understanding of NF; and

—To promote the development of and patient access to high quality medical care

for patients and their families.

PREPARED STATEMENT OF THE NATIONAL ORGANIZATION FOR RARE DISORDERS

Mr. Chairman and members of the Appropriations Subcommittee on Labor, HHS,

Education and Related Agencies, thank you for allowing the National Organization

for Rare Disorders (NORD) to submit testimony regarding funding for the National

Institutes of Health (NIH). We want to express our deep appreciation for all the

Subcommittee has done to ensure increased funding for biomedical research—research that has been used to reduce suffering and save lives.

The rare disease community is asking that the Office of Rare Diseases at the National Institutes of Health (NIH) be adequately funded to ensure that ALL Americans, not just a select few, have access to the incredible work being done at the

NIH. Today, only ten cents for each and every person suffering with a rare disease

or disorder is allocated to the ORD. We are asking for a mere $1 for each man,

woman and child who must sometimes wait years for a diagnosis—$25 million to

‘‘uncover new knowledge that will lead to better health for everyone.’’ 1 We are also

asking that ORD be given permanent status to allow for a diagnostic and research

center, and to expand the authority of the office because it does not currently have

a permanent line item in the NIH budget.

NORD is a federation of approximately 140 voluntary health organizations and

over 70,000 individual patients, healthcare providers and clinical researchers dedicated to helping people with rare ‘‘orphan’’ diseases. An orphan disease is defined
638

2The Orphan Drug Act, Public Law 97–414, January 4, 1983.

3 Red Herring, Adopting Orphan Diseases, by Thomas Maeder, January 16, 2001, p. 130. 4 Ibid.

by statute as any disease or condition impacting less than 200,000 Americans.2 It

makes no difference whether you are male or female, rich or poor, young or old,

white, African-American, Latino, Asian or American Indian. These diseases affect

everyone.

Rare ‘‘orphan’’ diseases include such better known diseases as Sickle Cell anemia,

Tay-Sachs disease, Hemophilia, Fanconi’s anemia, Tourette Syndrome, Lou Gehrig’s

disease, scleroderma, etc. It also includes obscure diseases such as Landau Kleffner

Syndrome, Wilson’s Disease, mastocytosis, Canavan disease, and fibrodysplasia

osssificans progressiva (FOP). In a recent article by Thomas Maeder in the Red Herring, FOP is described ‘‘as one of the strangest and rarest diseases of all, with about

125 patients in the United States.’’ The body mysteriously ‘‘transforms its muscles,

tendons, and ligaments into bone . . .’’ Internal organs are not affected and so patients can live normal life spans unless they ‘‘die from complications secondary to

their immobility, like pneumonia, falls, or choking on aspirated food.’’ 3

Our commitment to those 125 FOP patients and the estimated 25 million other

people suffering with the approximately 6,000 often debilitating and devastating diseases is the identification, treatment and cure of rare disorders. Approximately

5,000 of those conditions are genetic diseases. In fact, no research is being pursued

for most of them. You can imagine the frustration many of these people feel knowing that no one is willing or able to conduct vitally needed clinical studies to develop

new treatments or cures.

The mission of the National Institutes of Health is to ‘‘uncover new knowledge

that will lead to better health for everyone.’’ 4 Yet, millions are being left behind

simply because they lack the knowledge or vast resources available to many larger

disease groups that allow them to exploit the resources of the NIH. In fact, the National Commission on Orphan Diseases (DHHS, 1989) estimated that only 30 percent of the 25 million patients suffering with rare diseases receive a diagnosis in

three to five years after the onset of symptoms. That works out to about 7.5 million

patients who are shuffled from specialist to specialist, year after year. Fifteen percent, or 3.7 million people, wait seven years or more. Those statistics are both

frightening and unacceptable.

To help fill that void, the Office of Rare Diseases at the NIH was created in 1993.

Its mission is to:

—Stimulate and coordinate research on rare diseases

—Compile and provide information on rare diseases to patients and their families,

as well as researchers and physicians interested in conducting clinical research

—Co-fund with NIH Institutes and other organizations approximately 50 scientific workshops a year costing between $35,000 and $75,000 each to

—Stimulate research where none exists

—Establish research priorities

—Develop collaborative research protocols

—Encourage the exchange of ideas among investigators, voluntary patient support groups and NIH Institute staff to stimulate new research, and finally

—Take advantage of scientific opportunities

—Develop and maintain the Rare Disease Clinical Research Database describing

over 1,600 research protocols.

—Develop and maintain the Medical Genetics and Rare Disorders subfile of the

Combined Health Information Database (CHID)

—Provide information collected from voluntary patient support organizations

—Coordinate and provide liaison for the NIH with federal and non-federal national and international organizations concerned with rare disease research and

treatment of rare diseases.

—Identify current needs in the coordination of rare disease research in cooperation with voluntary health organizations, research investigators and the pharmaceutical and biotech industries

—Bridge the gap between basic and translational research

—Discover opportunities to increase research resources

—Develop novel methods of research planning, coordination and collaboration

This small office, funded with little more than $2.2 million for the 2001 fiscal

year, is the only central government resource available to 25 million people. When

you do the math, that $2.2 million works out to be less than ten cents for each and

every American suffering with a rare disease. And while the entire NIH is enjoying

increases of 14 percent and more, the ORD has seen increases of little more than

three percent.
639

5Thomas Maeder, p. 128.

We ask today that this Subcommittee consider the creation of one intramural research and diagnostic center for the study of rare diseases. The center should conduct research on rare diseases and conditions; take advantage of emerging research

opportunities; and, augment NIH Institutes’ research for neglected rare diseases.

We also ask that the responsibilities of the ORD be extended to include:

—Oversight of the intramural research and diagnostic center for the study of rare

diseases

—Recruitment of qualified academic scientists to participate in the grant review

process for rare disease research proposals

—Support of grants for clinical pilot studies

—Collaboration with industry to develop gene vectors for gene therapy experiments

—Expansion of existing programs to provide support for 100 scientific workshops

and symposia annually, and

—Development and maintenance of a central clearinghouse for rare and genetic

disease information, written in understandable language for use by patients and

their families.

Because rare disease patients are particularly impacted by the cost of diagnosis,

treatment and ancillary support services that can reduce a family to poverty, and

because patients must often travel long distances to academic hospitals to see the

few specialists who work on their particular disease, we also ask that this Committee consider the creation of four regional extramural diagnostic and research centers to expand patient outreach activities and facilitate the development of post-doctoral training fellowships.

Mr. Chairman and members of this Subcommittee, we deeply appreciate Congress’

commitment to increase research funding for the NIH by 50 percent over the next

five years because many have benefited from the groundbreaking work already

being done today. But we respectfully request that you appropriate a minimum of

$25 million to the Office of Rare Diseases for the coming fiscal year to help the 25

million Americans who look to you and all members of Congress for help.

Appropriating just one dollar for each rare disease patient in America who is suffering with a rare disease, rather than the current funding level of less than ten

cents, is a win-win situation. Patients win when their symptoms are alleviated or

cured. Families win when their loved ones no longer suffer. Society, as a whole, wins

when patients are able to return to school or work to become productive tax-paying

citizens. Pharmaceutical and biotechnology companies win when they are able to develop new therapeutic products. The scientific community wins when the knowledge

they gain can be applied to more prevalent diseases. And, finally, the government

wins when the drain on healthcare dollars is minimized.

I would like to leave you with a quote from Thomas Maeder’s article—‘‘Yet even

if the worries of the few were laid aside, and one cared only about bringing the biggest benefits to the greatest number of people, it would still make sense to study

rare diseases. We understand health through the observation of illness, and the

more illnesses we survey, the more we are likely to learn.’’ 5

Again, thank you for your continuing commitment to the National Institutes of

Health and your recognition today of the unmet needs of those who suffer with rare

‘‘orphan’’ diseases.

SUPPORTING DOCUMENTS

NATIONAL INSTITUTES OF HEALTH, APPROPRIATIONS—FISCAL YEAR 2001

[in thousands of dollars]

Institute, Center, or Division FY 2000

Estimate

FY 2001

Conference

Percent

Change

Cancer ........................................................................................... 3,310,992 3,757,242 13.5

Heart, Lung, and Blood ................................................................. 2,026,006 2,299,866 13.5

Dental and Craniofacial Research ................................................ 269,129 306,448 13.9

Diabetes and Digestive and Kidney Diseases .............................. 1,141,176 1,303,385 14.2

Neurological Disorders and Stroke ................................................ 1,029,528 1,176,482 14.3

Allergy and Infectious Disease ...................................................... 1,776,571 2,043,208 15.0

General Medical Sciences ............................................................. 1,353,660 1,535,823 13.5

Child Health and Human Development ........................................ 859,079 976,455 13.7
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NATIONAL INSTITUTES OF HEALTH, APPROPRIATIONS—FISCAL YEAR 2001—Continued

[in thousands of dollars]

Institute, Center, or Division FY 2000

Estimate

FY 2001

Conference

Percent

Change

Eye ................................................................................................. 450,007 510,611 13.5

Environmental Health Sciences ..................................................... 442,596 502,549 13.5

Aging ............................................................................................. 687,717 786,039 14.3

Arthritis and Musculoskeletal and Skin Diseases ........................ 349,407 396,687 13.5

Deafness and Other Communication Disorders ............................ 263,606 300,581 14.0

Mental Health ................................................................................ 974,470 1,107,028 13.6

Drug Abuse .................................................................................... 687,232 781,327 13.7

Alcohol Abuse and Alcoholism ...................................................... 293,173 340,678 16.2

Nursing Research .......................................................................... 89,521 104,370 16.6

Human Genome Research ............................................................. 335,792 382,384 13.9

Research Resources ...................................................................... 674,913 817,475 21.1

Complementary and Alternative Medicine .................................... 68,997 89,211 29.3

Fogarty International Center ......................................................... 43,319 50,514 16.6

Library of Medicine ........................................................................ 215,154 246,801 14.7

Office of the Director .................................................................... 281,941 213,5812 ¥24.2

National Center on Minority Health and Health Disparities ......... .................... 130,200 N/A

Buildings and Facilities ................................................................ 165,3501 153,790 ¥7.0

Total ...................................................................................... 17,789,336 20,312,735 14.2

Office of Rare Diseases ................................................................ 2,070 2,153 3.8

1 Includes $40 million in advance funding from the previous year.

2 The Office of the Director shows a significant loss in fiscal year 2001 due to the carve-out of funds for the newly established National Center for Minority Health and Health Disparities.
641

PREPARED STATEMENT OF THE NATIONAL PSORIASIS FOUNDATION

Mr. Chairman and Members of the Appropriations Subcommittee: Thank you for

allowing the National Psoriasis Foundation (NPF) this opportunity to present written testimony to the committee on the subject of NIH appropriations, particularly

as regards skin disease research conducted through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

We write to urge the committee to approve an allocation for NIAMS of $462.2 million for fiscal year 2002, an increase of 16.5 percent over current funding levels.

This increase would further the commitment to double the NIH budget in five years

and critically increase the ability of our nation’s scientists to uncover the secrets of

diseases such as psoriasis and psoriatic arthritis.

We make this request on behalf of more than 7 million American men, women

and children with psoriasis and psoriatic arthritis—chronic, debilitating genetic skin

and joint diseases. Psoriasis is a common disease that affects one person in forty,

and yet it is a disease without a cure and without universally effective treatments.

Until a cure or more effective treatments are found, millions of people with psoriasis

face a lifetime fighting this disease, which costs our nation billions of dollars annually and, immeasurably, in the tragic emotional and physical toll psoriasis can take

on its victims.

Children.—I am 10 years old, and I have psoriasis. It really itches a lot, and I

can’t do gym at school because it cracks open and it hurts really bad. I look at it

and I cry....

Teenagers.—There are many times when I look at myself in the mirror and just

cry because I look so bad. I haven’t gone swimming for years now....

I live in the South, and I wear long sleeves and pants even in the summer to hide

my psoriasis. My best friends have never seen my legs, I’m too ashamed....

The Elderly.—My medicines are so expensive, I often can’t get my prescriptions

filled. Psoriasis has taken such a toll on my life. Many times I’ve had to stand in

the shower to soak my clothes of off my skin.

—More than three billion dollars are spent annually on psoriasis treatment.

—Each year psoriasis patients make approximately 2.4 million visits to dermatologists.

—Each year several hundred people with debilitating psoriasis are granted disability by the Social Security Administration.

—One person in five with psoriasis has disease that interferes with their ability

to perform everyday tasks, including employment and childcare.

Psoriasis is chronic, unpredictable and often unrelenting. Treatments may be successful for only relatively short periods of time for only some people. The thick, red,

scaly patches on any or all parts of the body can limit daily activities and interfere

with physical, occupational and psychological functions. Skin affected by psoriasis

may itch, burn, sting and easily bleed. Physically, psoriasis can range in severity

from mild to disabling. Three-quarters of a million of the people diagnosed with psoriasis are under the age of ten.

As many as 20–30 percent of people with psoriasis—more than one million people—also suffer from an associated arthritic condition, psoriatic arthritis. Psoriatic

arthritis can cause significant disability, disfigurement and impairment of quality

of life. The occupational impact of psoriasis and psoriatic arthritis not only poses

a significant economic burden for this nation but also a significant hardship for the

person with psoriasis.

Moderate-to-severe psoriasis, which affects as many as 2 million American men,

women and children, dramatically inhibits a person’s ability to maintain a normal,

healthy, active lifestyle. Plaques on large areas of their skin may restrict their

movement and the pain and itching often disrupts their sleep and their ability to

work. Psoriasis on the palms of the hands or the soles of the feet can be disabling,

preventing people from grasping a pen, holding their child, walking or standing.

These people have psoriasis that cannot be controlled by simple topical treatments. To manage their disease they require expensive, inconvenient phototherapy

(ultraviolet radiation) treatments in a doctor’s office, or oral systemic medications

that put the patient at risk of serious side effects. Some types of psoriasis require

hospitalization and can even be life threatening.

Emotionally, psoriasis can be devastating. The social rejection and physical suffering of psoriasis can lead people to suicide. Many psoriasis sufferers struggle

throughout their lives with pain, embarrassment, and shattered self-image.

Like diabetes, arthritis and heart disease, psoriasis requires lifelong treatment.

Indeed, a recent survey shows that 48 percent of Americans would actually prefer

to have heart disease, asthma or diabetes, all of which are life threatening, instead

of psoriasis. Unlike diabetes or heart disease, however, psoriasis is not a top priority
642

for many researchers or pharmaceutical companies. But thanks to focus and funding

provided by NIAMS, recent research has identified several possible sites for the

genes that may cause this inherited condition. Scientists tell us that a real cure for

psoriasis will come from these critical genetics studies.

Other research has begun to pinpoint the autoimmune component of the disease,

providing valuable targets for drug development. Many of the same autoimmune

processes that researchers have discovered at work in diseases such as rheumatoid

arthritis and Crohn’s disease are also active in psoriasis. For instance, researchers

are now finding that testing new therapies in psoriasis can be an effective way to

determine both if a new drug is safe and effective for psoriasis, and also if it may

work in these other diseases. This research must be aggressively supported, as research in one disease will very likely benefit others.

Effective treatments and a cure for psoriasis are within reach. Sufficient funding

will enable medical science to find a cure for this chronic, costly and devastating

disease. This not only will benefit the 7 million American children and adults now

suffering with this chronic disease, but also will help the 200,000 people who are

diagnosed each year with new cases of psoriasis.

Better treatments or a cure for psoriasis will result in savings both to the public

and the government in treatment costs, lost workdays and Social Security disability

claims. Beyond these valuable dollar measurements, an increase in federal spending

for such biomedical research will directly result in an immeasurable improvement

in the quality of life for these millions of affected Americans.

Therefore, on behalf of the members of the National Psoriasis Foundation, and the

7 million Americans with psoriasis, we again strongly urge you to approve $462.2

million for NIAMS, an increase of 16.5 percent over current funding levels for fiscal

year 2002. This increase will have significant health and socioeconomic benefits for

the millions of Americans who are affected by psoriasis and by other diseases under

the purview of NIAMS.

Thank you for your time and your support.

PREPARED STATEMENT OF THE NATIONAL SLEEP FOUNDATION

Mr. Chairman, distinguished Members of the Subcommittee, thank you for allowing me to submit testimony for the hearing record on behalf of the National Sleep

Foundation. I am the Medical Director for the Center for Sleep Disorders at Doctor’s

Hospital in Massillon, Ohio. Since 1994, I have also been a coordinator for the Wake

Up America Coalition focusing on reducing drowsy driving crashes in Ohio.

The National Sleep Foundation (NSF) is an independent, non-profit organization.

NSF works with thousands of sleep experts, patients, and drowsy driving victims

throughout the country to prevent health and safety problems related to fatigue and

untreated sleep disorders. The Foundation’s interest in the Subcommittee’s work is

based on NSF’s relationship with the Centers for Disease Control and Prevention

(CDC), and specifically with the National Institute on Occupational Safety and

Heath (NIOSH) and the National Center for Injury Prevention and Control

(NCIPC). NSF is asking the Subcommittee to consider providing an additional $1.5

million in fiscal year 2002 funding between NIOSH and NCIPC to address sleep

deprivation and fatigue-related injury in this country.

SLEEP AND PUBLIC HEALTH

We recognize the many competing priorities that the Subcommittee must consider

as it writes the appropriations legislation for fiscal year 2002. At first glance, sleep

and fatigue issues may not appear to be an immediate concern to the nation’s health

and safety. However, all you need to do is stop and ask yourself, how do I perform

when I am tired? Have I ever driven while drowsy? Do I know someone with a sleep

disorder? Can a child learn when they can’t stay awake in class? As a sleep physician, I can tell you first-hand that insufficient sleep and sleep disorders have a profound impact on millions of people’s lives.

Sleep represents a third of every person’s life, and it has a tremendous impact

on how we live, function, perform, and think during the other two-thirds of their

lives. Sleep is as vital as the air we breathe and the food we eat, yet for many, it

is last on the ‘‘to do list.’’ Too many of us forget that lack of adequate, restful slumber has serious consequences at home, in the workplace, at school, and on the highway. Tragically, drowsy driving claims more than 1,500 lives and accounts for at

least 100,000 crashes in the United States every year. Untreated sleep disorders

and sleep deprivation contribute to accidents, impaired work productivity, academic

performance, reduced quality of life, poor health, and even death.
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FATIGUE AND PREVENTABLE DEATH AND INJURY

We know that tens of thousands of lives are endangered, if not lost, each year

because of fatigue. Some of them are high profile. For instance, fatigue was cited

in disasters such as the Exxon Valdez oil spill in 1989, and the commercial airline

crash in Little Rock, Arkansas in 1999. Some of the losses do not make the evening

news, but they are tragic just the same. Just last year, nine Boy Scouts and two

Troop leaders from New Kensington, Pennsylvania, were hurt when their van

flipped over after the driver simply fell asleep at the wheel when coming back from

a camping trip. People who don’t drive automobiles are not immune from the danger. In 1998, a 6-year-old Kirkwood, Pennsylvania, Amish girl was killed on Route

896 in Bart Township after a driver fell asleep and smashed into the back of a

buggy in which she was riding. These crashes, along with workplace accidents, happen every day throughout America. The tragedy is that these accidents are eminently preventable.

Fatigue or sleep deprivation is an impairment, comparable in effect to alcohol and

drugs. New research tells us that a person who has been awake for 24 consecutive

hours demonstrates the same impairment to judgment and reaction time as an

adult who is legally drunk with a blood alcohol concentration of 0.10 percent. Furthermore, people do not realize that alcohol interacts with sleep deprivation to form

a deadly combination. An adult with only four or five hours of sleep may think he

or she is drinking responsibly when they have one or two drinks after work, but

in this case, what he or she does not know can kill them or someone else. Like drugs

and alcohol, fatigue needs to be addressed as a public health issue.

RAISING AWARENESS ON SLEEP AND FATIGUE IMPLICATIONS

The National Sleep Foundation has worked with volunteers like myself for the

last decade to raise awareness, have people diagnosed and treated, and minimize

fatigue-related injuries. NSF, in cooperation with many partners, has successfully

mounted state programs in New York, Arkansas, California, Washington, Oregon,

and Idaho that target fatigue-related injuries. In New York, NSF worked with state

and federal agencies and other partners to launch the nation’s first statewide public

information and injury prevention program related to the dangers of sleep deprivation. In March, NSF worked with over 80 diverse national organizations, state and

federal agencies and more than 350 sleep centers to hold a National Sleep Awareness Week, prior to Daylight Saving Time, when Americans lose a precious hour of

sleep. This comprehensive, award-winning public education campaign, now in its

fourth year, generates tremendous public awareness of how good sleep contributes

to health, safety, and productivity.

While public awareness is desperately needed, a strong federal partner with the

expertise and ability to disseminate tested and proven education, training, and injury prevention programs to communities like New Kensington and Bart Township

are needed even more. The CDC is the partner that NSF and public health officials

need to help us address the comprehensive and complex health and safety problems

related to sleep issues.

The problem is complex and far-reaching. Complex in that, while there are many

unanswered questions about the relationship between sleep, rest, and physical performance, the sleep research community has established that sufficient sleep is not

optional. The costs are as immediate a disabling farm equipment accident and as

debilitating as mental disorders, seemingly unassociated with sleep patterns. Farreaching in that the NSF has identified several significant steps we need to take

in the public health field. Public education, physician and police training, schoolbased programs, workplace safety—these are some of the obvious program pieces

that the Foundation sees a need to initiate.

We have data telling us that lack of sleep affects the nation on many different

levels—from the airline pilot in the skies to the child in the classroom, from the solider in battle to our farmers in the field. But this research does no good if we cannot

translate it into education and injury prevention programs for the general public.

We believe that the CDC can and should play a vital role, working with the sleep

community, to address these problems by developing a Sleep Action Plan that would

set national priorities around sleep issues in public health and safety. The proposed

plan would better identify the specific public health problems associated with sleep

and sleep deprivation, gather the relevant data to inform policy decisions, and recommend policy direction and plans for implementation.
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AWARENESS IN MEDICAL COMMUNITY

The National Institutes of Health estimates that more than 40 million Americans

suffer from chronic sleep disorders, and millions of others suffer intermittent sleep

problems related to other medical problems like depression, diabetes, Parkinson’s

Disease, arthritis, and cancer. The overwhelming majority of these people are

undiagnosed and untreated due to a lack of public understanding of symptoms and

the training of physicians in medical schools. A Foundation survey found 58 million

Americans report suffering excessive daytime sleepiness at levels that interfere with

day-to-day activities.

We believe increasing awareness on the role of sleep and the prevalence of sleep

disorders in the medical community is a crucial element of addressing the problem.

One example of how a physician education initiative can make a difference in people’s lives is from Walla Walla, Washington. Several primary care physicians in

Walla Walla, Washington, were trained to look for and recognize symptoms of sleep

apnea, one of the more common and subtly debilitating sleep disorders. With this

training, physicians were able to diagnose and ultimately recommend treatment to

hundreds of people for sleep apnea and other sleep disorders. A control group of

physicians without specific training only diagnosed a tiny fraction of these cases.

The moral of the story is not that there are many people with sleep disorders in

Walla Walla, but that countless Americans needlessly suffer from sleep disorders.

These people are one step away from serious tragedy because their physicians have

not been provided with the training they need to diagnose and treat them. Accurate

data from the health care community along with additional training would show the

extent of the problem and allow us to target physicians who are on the front lines

of our health care system to tackle this problem before it gets further out of hand.

The lack of knowledge evident in Walla Walla prior to the community-based intervention by sleep physicians was confirmed in a recent study by the National Sleep

Foundation. The NSF released data in January 2001 that indicated that while 98

percent of primary care physicians believe that questions about a patient’s sleep

should be part of a routine checkup, only half of the doctors stated that they ever

asked such questions. Maybe more telling is that most physicians admitted that

their colleagues were likely to only talk about sleep if the patient initiated the conversation.

VULNERABLE SUB-POPULATIONS

One of the largest groups affected by fatigue is young adults. Twenty years of research shows us that older adolescents require about nine hours of sleep a night

to maintain proper alertness during the day. Sleep specialists also indicate that during puberty, a shift in the biological clock occurs, making it difficult for teenagers

to get to sleep before 10 p.m. In fact, studies have found that the average high

school student does not go to bed until midnight. This pervasive sleepiness creates

what is called a ‘‘sleep debt,’’ which profoundly affects health, safety, productivity,

and learning abilities and makes teens the largest at-risk group for fall-asleep car

crashes. Evidence tells us that America’s ‘‘sleep debt’’ is on the rise, but we, as a

nation, lack the basic resources to address this problem.

Another sub-population at risk for sleep loss is overweight children. As the Members of the Subcommittee may know, America’s children are more obese than ever.

The CDC has stated that this health issue is reaching epidemic proportions. As a

result of this alarming weight gain, my colleagues and I are seeing more and more

children developing obstructive sleep apnea at younger ages. Left untreated, sleep

apnea leads to higher healthcare utilization and is associated with cardiovascular

disease, diabetes, stroke, depression, and other very serious medical conditions. People with untreated sleep apnea also have up to a seven times greater risk of falling

asleep behind the wheel of an automobile.

SUMMARY

Current CDC resources within the National Center for Injury Prevention and

Control and the National Institute on Occupational Safety and Health are allocated

for other projects that are of equal importance to the country. It is with this recognition that we ask the Subcommittee to increase the overall budget at NCIPC and

NIOSH by $1.5 million to allow CDC to act as the coordinating body for the development and implementation of the five-year Sleep Action Plan. This plan will allow

the NSF, CDC, and other federal agencies to develop and distribute accurate, medically sound information and programs to local communities. This information, coupled with training for those involved with public health and safety at the state level,

will begin to turn the tide of injuries, health problems, and costs associated with
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sleepiness and sleep disorders. We are ready and willing to take up this challenge,

but we need your help.

Thank you for consideration of this request.

PREPARED STATEMENT OF THE NEPHCURE FOUNDATION

SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS

Continue the effort to double funding for the National Institutes of Health by pro- viding an increase of 16.5 percent, to $23.7 billion for fiscal year 2002. Increase

funding for the National Institute of Diabetes and Digestive and Kidney Diseases

(NIDDK) by 16.5 percent to $1,518,443,525 for fiscal year 2002.

Prioritize glomerular injury research at NIDDK (including clinical trials), raise

professional and public awareness about glomerular injury, and encourage more aggressive scientific attention to all kidney diseases.

Urge NIDDK to develop programs to attract talented researchers to the field of

glomerular injury.

Mr. Chairman, and members of the subcommittee, I am pleased to present testimony on behalf of the NephCure Foundation (NCF).

We are a relatively new, non-profit organization with a mission of supporting research and public awareness on glomerular injury, which is related to the filtering

mechanism of the kidney. I serve as president of the foundation, and have a son,

who has had a glomerular disease since he was eleven months old. Although he is

now 24 years old and in remission, eighty percent of those in his situation lose their

kidneys or their life by the age of five.

What is glomerular injury?

Mr. Chairman, each kidney contains about one million tiny filtering units called

nephrons. Nephrons are the key to the kidney’s filtering function, processing a constant flow of waste-laden blood, sorting out the vital fluids, from the toxic and unnecessary elements.

When someone suffers from a glomerular disease, this vital process is impaired.

In some instances, an individual will lose protein and sometimes red blood cells in

the urine, have high cholesterol levels, and experience severe swelling in the body

from too much fluid. Incidence of this disruptive Nephrotic Syndrome is increasing,

and this perplexes physicians who cannot identify the cause or cure.

Sometimes damage occurs to the nephrons, specifically, scarring of the glomeruli,

which are microscopic capillaries in the nephron. The severe form of this glomerular

injury is Focal Segmental Glomerulosclerosis (FSGS). Presently, there is no treatment to reverse this damage. FSGS can lead to end stage renal disease—total, or

near total, permanent kidney failure. Costly dialysis treatments become necessary

and kidney transplants may be required for severe cases.

The Toll of Glomerular Injury

Glomerular injury affects tens of thousands of patients in the nation, most of

them young. While it is unclear exactly how many Americans are impacted, the incidence of glomerular injury is on the rise. Severe forms of glomerular injury are costly to diagnose and treat, and at this time the only relief for these patients is with

heavy medication, usually steroids, which have strong and unpleasant side effects

and only work for about 30 percent of patients.

Problems of misdiagnosis often occur with glomerular injury. Most patients and

parents have stories about the unusual length of time between the first symptoms

and diagnosis. The early signs of glomerular injury, swollen eyelids, are often mistaken for allergic reactions. Health care professionals don’t appear to be fully knowledgeable about this disease.

The physical changes, extreme swelling of the face and body, can adversely affect

all aspects of a young person’s life. With a stronger commitment to research and

educational awareness, suffering can be minimalized and hopefully eliminated.

There is hope for scientific breakthroughs

At a meeting co-sponsored by the NephCure Foundation, preeminent scientists

from around the world have shared their findings about the podocyte, a major filtering cell, with tentacle-like feet. The relationship between the podocyte and the

glomerulus may be a key to understanding glomerular injury.

Recently, researchers have discovered certain molecules that are essential to the

podocyte’s function. As this becomes better understood, scientists are hopeful of finding better ways to treat glomerular diseases, and prevent their progression to more

grave conditions.
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This spring, NIDDK will begin to establish clinical trials, which will test various

treatments for hundreds of FSGS patients. But there is a need for more funds to

strengthen the basic science behind these studies. Researchers need to study tissue

and fluids from those patients to advance their knowledge of the molecular causes

of FSGS.

What needs to be done?

Respectfully, Mr. Chairman, the NephCure Foundation urges this subcommittee

to:

—Continue the support for doubling the National Institutes of Health (NIH) and

the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

—Provide the funding and recommendations for the National Institute of Diabetes

and Digestive and Kidney Diseases to aggressively pursue a scientific program

which will advance research into glomerular injury, conduct clinical trials, raise

public awareness, and recruit talented scientists to this field of research.

Thank you for the opportunity to appear before you today.

Mr. Chairman, we hoped to have Melanie Stewart here to testify today, but her

health would not allow her to be here. Her father, Brad Stewart, will read Melanie’s

statement.

My name is Melanie Stewart. I’m 13 years old and have had FSGS since I was

six. Until a year ago I spent most of my life in the hospital or hooked up to a dialysis machine for 8 hours every day. My kidneys finally died last year, so my dad gave

me one of his. I’ve done my best to keep it by taking 20 pills a day, fighting off

infections, hemorrhages, and a blood clot in my heart. The kidney my Dad gave me

is failing.

There are thousands of kids just like me who would like a chance at a normal

life. For all of us, I’m asking for your help in finding a cure for this disease.

Thank you for listening.

PREPARED STATEMENT OF NEW YORK UNIVERSITY

On behalf of New York University, I appreciate the opportunity to speak in support of public investment in basic research and, in particular, to salute the National

Institutes of Health, whose funding of biomedical and biological research is so important to the health and well being of our nation.

The NIH has benefited in recent years from significant budget increases that have

enabled important new NIH initiatives and funded path breaking research conducted by both NIH as well as university-based researchers. NIH supports established as well as junior investigators, funds research as well as facilities and instrumentation, and shapes emerging areas of biomedical research. NIH funding is critical both for its direct support of research, as well as its indirect impact in enabling

extramural (university-based) researchers to attract additional funding from other

federal agencies, private foundations, and industry for research and science infrastructure. We at NYU applaud the national goal of doubling the NIH budget to $30

billion by 2003, and urge Congress and this Committee to support that proposal. A

strong NIH is absolutely essential to meet the new challenges in biology, biomedicine, and health care.

At New York University, NIH funding has supported leading-edge research across

a range of areas from molecular genetics of plants to computer modeling of DNA

structures to neural visual pathways to language comprehension. I would like today

to underscore biomedical genomics, an important and pervasive area of contemporary biomedical research that is a very important priority for NIH and is, as well,

an area in which NYU is well-positioned to make major contributions.

The implications of the NIH National Genome Project for America cannot be overstated. Its scope of investigations and applications encompasses every living thing—

humans, animals, and plants—and has the potential to revolutionize disease

diagnostics and therapy, agricultural applications, environmental conservation, and

indeed, our most cherished notions of life.

ADVANCES IN GENOMICS

The genome is the recipe or blueprint for life. During the last decade—and particularly, during the last few weeks alone—the unraveling of the genetic code has

opened up a vast range of new opportunities for evolutionary and developmental biologists, neurobiologists and chemists to understand what genes are, what they do,

and how they do it. Genomics is revolutionizing biology and is dramatically changing the way we characterize and address biological questions. As a field which straddles biology, chemistry, and mathematics, genomics is growing extraordinarily rap-
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idly and transforming these disciplines, as well as the social and behavioral

sciences.

In its first stage, the revolution in genomics was characterized by a period of intensive development of techniques to analyze DNA, first in simple models, like

yeast, bacteria, the worm, and the fruitfly, then in the mouse, and now in humans.

The structure and function of genes are similar in these models, making comparisons useful. The second phase was characterized by the use of these tools to address

whatever biological question was most easily approached, given the state of technique development. It may be described as structural genomics—which comprises

the mapping and sequencing of genomes and is mainly driven by technology. The

scientific community is now poised to enter the third phase of the genomics revolution in which investigators bring perspectives from other fields, like immunology,

genetics, and neurobiology to pursue investigations that are driven by hypothesis

rather than technique. This third phase is generally termed functional genomics and

uses the map and sequence information already collected to infer the function of

genes. Functional genomics integrates basic and clinical science: the strategy is to

exploit genomics approaches to address the relationship between the genes identified in model organisms—like the worm, or the fruitfly—and the genes responsible

for human disease states.

At New York University, we think the key issues facing genomics today are how

to translate the enormous quantities of gene sequence data into knowledge of gene

function. The answers lie, we believe, in comparative functional genomics, an approach that looks for the occurrence of the same genes in different species that

share certain structures or functions, and provides a powerful method for understanding the function of particular genes. Comparative functional genomics uses two

primary modes of analysis: (1) identifying what has been conserved over long evolutionary distances, and (2) determining crucial differences that distinguish two closely related species. This focus can provide the key to understanding the genetic basis

of disease states that are dependent on numerous genes and to unraveling the complex regulatory networks for crucial biological functions.

STRENGTHS AT NEW YORK UNIVERSITY

New York University and other major research institutions are poised to make

important contributions to the next phase of genomics research.

Studies in comparative functional genomics, the thrust of NYU research, is necessarily multidisciplinary, and indeed, involves multiple institutions. This approach

synergizes medically related research programs, such as those at the NYU School

of Medicine and its affiliated Mount Sinai School of Medicine, with basic science research programs such as those at NYU’s Faculty of Arts and Science. This approach

recognizes that an essential feature of emerging genomics studies is an intimate tie

of biology to computer science. The mass of data involved in genomics strains computational capacity and analytic tools. This has spawned a new scientific discipline,

bioinformatics, whose focus is developing entirely new algorithms for large-scale

database management, alignments, pattern recognition and data processing for application to genomic sequences. Accordingly, genomics studies at NYU are essentially rooted in computational investigations at its Courant Institute of Mathematical Sciences.

NYU has substantial strengths in areas important to genomics, including evolutionary biology, neurobiology, developmental genetics and applied mathematics research, imaging and computation, and extends this expertise through active collaboration and formal affiliations with premier metropolitan area institutions, including

The New York Botanical Garden, which houses the world’s largest collections of

well-characterized specimens from the plant kingdom, and Cold Spring Harbor Laboratory, one of the world’s centers for molecular biology and genomics research.

NYU Medical School has outstanding programs in developmental genetics, molecular neurobiology, pathogenesis and structural biology. And Mount Sinai Medical

School has an internationally acclaimed program in human genetics and has begun

to use genomics approaches to identify the origins of human genetic disorders. The

multidisciplinary perspective that characterizes genomics—particularly comparative

functional genomics—requires this kind of concentration of strengths in biological,

neurobiological, and computational sciences, and established frameworks for interdisciplinary and interschool collaboration.

The nation’s largest private university, with 13 schools and over 49,000 students,

NYU is a leading center of scholarship, teaching and research. It is one of 29 private

institutions constituting the distinguished Association of American Universities, and

is consistently among the top U.S. universities in funds received from foundations

and federal sources. NYU encompasses a pre-eminent science faculty and generates
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substantial external funding from federal and state agencies as well as the private

sector. These investigations have attracted millions of federal dollars from the NIH,

NSF, ONR, and EPA. In addition, NYU has received major funding from the most

prestigious private foundations supporting the sciences, including the Howard

Hughes Medical Institute, the W. M. Keck Foundation, the Alfred M. Sloan Foundation, and the Beatrice and Samuel A. Seaver Foundation. Faculty members have,

as individuals, won prestigious awards, including HHMI Investigator, NSF Presidential Faculty Fellow, NIH Merit Awardee, McKnight Foundation Scholar in Neuroscience, and MacArthur ‘‘Genius’’ Fellow.

RESEARCH APPLICATIONS AND NATIONAL BENEFITS

Concentrated studies in comparative functional genomics can be a major resource

for the research and development activities of academic organizations and commercial firms; can provide a strong framework for direct and indirect economic development in vital, high-tech industries; and can offer benefits to our citizens from improved health care, and technology development. Further investment in state-of-theart equipment, and in facilities where computer scientists, physical chemists, and

geneticists can readily interact with each other is essential for the development of

this field.

Advances in Biomedical and Other Research Fields.—The understanding of the

human genome is a field which is particularly fertile with applications to cell biology, embryology, developmental biology, study of cancers and many other heritable

diseases, immunology, endocrinology, neurology, and population genetics. Genomics

brings together laboratory scientists in all these fields with formerly unrelated disciplines, and can stimulate expansion in key directions in genetics, physical chemistry, evolutionary studies, and diagnostics. Functional genomics research has created a need for information processing structures that efficiently compare multiple

strands of DNA, each represented by thousands of kilobytes of data, and allow

groups of strands to be represented graphically in a way that highlights their common elements and differences. These research challenges overlap with the fields of

machine vision, robotics, and combinatorial mathematics. As an example, computer

scientists at NYU are working closely with molecular geneticists and business entrepreneurs to develop a library of genomics software tools. Some of these tools are already being considered by medical researchers for use in diagnosing tumors, which

have a genetic structure different from healthy tissue.

Biomedical Applications for National Health Needs.—An investment in genomics

research will have a heavy payoff in the nation’s well-being by advancing the frontiers of knowledge, finding new cures and treatments for diseases, and helping to

develop new diagnostic technologies. For example, it is known that heart cells dying

from oxygen deprivation cause heart attacks. It is also known that mice are usually

more susceptible to low-oxygen heart attacks than humans. The hearts of certain

breeds of mice, such as the high-altitude deer mouse, have the surprising genetic

capability to adjust themselves to endure oxygen deprivation. Studies conducted by

genomics researchers at NYU are focused on isolating the gene that allows this adaptation and considering the implications for heart attack prevention. Clinical applications like this hold enormous promise to revolutionize medicine and our understanding of both normal development and disease. Genomics research may lead to

lifesaving technologies for diagnosis, prevention, and cure of diseases and disorders

such as diabetes, heart disease, cancer and infectious disease. In particular,

genomics science has the potential to revolutionize the development of mass screening tests for genetic disorders, ultimately making it possible to identify the hereditary contribution to common diseases, predict individual responses to drug intervention, and design drugs that are customized for individual use.

Economic Development.—In a now familiar dynamic of university-centered economic growth, industry draws on the faculty’s entrepreneurial energies, their expertise in training the personnel needed to staff high-technology firms, and the fundamental scientific research that can translate into practical applications. High-tech

firms spring up near a research university and, in turn, attract or spin off additional

high-tech firms in the same or related fields. The interaction of scientists across

firms makes the spread of information quicker and the development of projects more

rapid. Initial firms and newer firms share a growing pool of highly trained personnel. The expansion of the skilled labor pool makes hiring easier; the existence

of the pool attracts still more firms. Once a core of high-tech industries locates in

an area, venture capitalists identify that area as promising. The flow of capital—

a key ingredient for high-technology growth—increases. Once the process of agglomeration begins, it can be expected to grow on itself and become self-reinforcing.
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1The multiplier is for 1995 and is based on 1987 benchmark input-output accounts for the

U.S. economy and 1994 regional data, adjusted for 1995 inflation. See the latest (March 1997)

edition of the BEA publication Regional Multipliers: A User Handbook for the Regional InputOutput Modeling System (RIMS II). These multipliers are frequently used in studies of the economic impacts of individual universities and colleges.

University funded genomics studies have the potential to identify and characterize

genes of scientific and economic importance in pharmaceutics, biotechnology, industrial processing, and agrigenomics, including those directly applicable to human

health and well-being. New data about the function of genes has widespread commercial applications, including, the development of novel human and veterinary

therapeutics and diagnostics; the generation of data to provide better management

of patient care, such that medicine becomes more ‘‘customized’’ as it becomes possible to determine which individuals will benefit from which therapies; and agricultural applications, including the development of crops with improved characteristics

such as resistance to herbicides, lack of moisture, and other adverse conditions, or

improved growth capabilities.

R&D investment in genomics is already energizing bio-technology, pharmaceutical, biomedicine, agbiotech, computer software, and engineering enterprises. As

the genomics research base expands, there is likely to be a generation of new

commercializable technologies. Genomics studies will meet critical needs of existing

companies for basic research leading to developments in pharmaceuticals, industrial

processing, and bioinformatics, specifically, large scale functional genomics studies

to validate genetic targets and bioinformatics studies to guide drug discovery efforts.

Genomics research is also likely to spawn the growth of new companies, including

bioinformatics and software companies and genomics platform companies that generate specific genomic data for product development.

Research and development funding for genomics will also spur job growth. Academic R&D, although itself not directed towards specific commercial application,

provides the focus for attracting industry and serving as a base for commercial spinoffs. A conservative approximation that uses state employment multipliers maintained by the U.S. Commerce Department’s Bureau of Economic Analysis points to

immediate employment impacts of academic R&D. The BEA calculates that each $1

million in R&D grants supports roughly 34.5 full and part time jobs 1 directly within

the university and indirectly outside the university as the university’s expenditures

ripple through the local and state economy.

Investment in genomic science is a strategic and efficient vehicle for advancing

fundamental studies in a wide variety of scientific fields, facilitating biomedical applications that can greatly enhance the public welfare, and energizing existing and

new industries. The commitment of this committee to support the National Institutes of Health and its genomic initiative is greatly appreciated. We urge Congress

to continue its commitment to doubling the NIH budget. We firmly believe that a

federal investment in these and other biomedical research fields repays itself many

times over.

PREPARED STATEMENT OF JAMES AND MARGARET NYEHOLT

Dear Mr. Chairman: Thank you for allowing us to testify as to why orphan diseases—particularly Canavan disease—desperately need government funding for

medical research. Canavan disease is a model disease for other neurodegenerative

diseases such as Alzheimer’s, Parkinson’s, MS, and ALS. Medical breakthroughs

against Canavan disease have the potential to also benefit so many Americans suffering from other debilitating neurological diseases. In the case of Canavan disease,

we are dealing with a 100 percent fatal illness that affects children. Most Canavan

children do not survive their 10th birthday.

When our precious grandson (Max Randell) was diagnosed with Canavan disease

(CD) at 4 months old, our lives were forever changed. We sat in a room with our

daughter and son-in-law as our family was told that our darling Max would disintegrate before our eyes. We were told that Max had a fatal progressive brain disorder

affecting the formation of myelin or white matter of the brain. We learned that the

childhood victims of CD were among the most profoundly disabled people in the

world. We sat in horror as the doctors went on to tell us that because CD is progressive, the children eventually lose all motor function, becoming blind, paralyzed, and

require feeding tubes. Canavan children’s brains slowly dissolve into a spongy mass,

and even the most elementary signals cannot reach their destination. As respiration

slows to the point where the lungs can longer function, they usually succumb to a
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common illness such as pneumonia. We were also told that there was no treatment

or cure for this devastating illness.

We decided to fight back against this disease. Without government help, our family has tirelessly fundraised for the past three years to fund groundbreaking medical

research for clinical interventions against Canavan disease. During the course of the

past three years, we have formed a public charity devoted to finding a treatment

and cure to give these children a chance. We know there is hope, as our grandson

participated in an experimental therapy (solely supported through fundraising efforts) where four out of fifteen children produced new myelin. These remarkable results were confirmed by MRI’s and additional follow-up tests. Max is one of these

children, and we have personally witnessed his gaining vision (his whole world

opened up) and the great improvements in his quality of life. These improvements

are now fading and we are desperately fundraising to support another trial. We

need our government’s help to fund research to give these children a chance at the

life they so deserve.

The Canavan children love life; they are very loving and social children, although

they are trapped in bodies that can respond only in very limited ways. These children are fighters and we are fighting for them, however without government help,

by granting additional funds to the NIH (with encouragement to grant more research funds towards medical interventions for the children battling CD) we cannot

move forward.

We are in our late fifties. We have spent much of our retirement savings to help

to save Max and the Canavan children, and we are exhausted and reaching out to

our government for help. Both of us have worked all of our lives, never asking for

any type of government help. We both work full time, and are devoted parents and

grandparents. Most evenings we are up until 2 AM writing fundraising letters to

support medical research to treat and cure Canavan disease. Over the past two

years, Jim has lost a kidney due to Kidney Cancer, yet we still devote endless time

to trying to save these precious children. We are fueled by our love for our grandson

(and the other Canavan victims we have met), as well as the knowledge that advancements against Canavan disease will truly aid in developing treatments for

other neurodegenerative diseases.

Medical research is overwhelmingly expensive to be solely funded by private donations. Mr. Chairman, we are hopeful that (coupled with granting additional funds

to the NIH) you will also encourage them to make an effort to grant more research

funds towards therapeutic medical interventions for the little victims of Canavan

disease. Without government grants we cannot raise the millions of dollars necessary to continue to support crucial medical research. The Canavan children are

running out of time. By helping us to save these children’s lives, millions of other

Americans suffering from degenerative brain diseases also stand to benefit from this

promising research.

PREPARED STATEMENT OF DR. CHRISTINA O’CONNOR

My name is Dr. Christina O’Connor from Lake Bluff, Illinois. Dentistry has been

my pursuit and profession for over half of my life. I have become latex allergic by

wearing latex gloves in my dental practice. I started working in dental offices during high school and college. After graduating from Loyola University with a degree

in psychology, I earned a Certificate in Dental Hygiene at Loyola University and

began to work as a dental hygienist. While in a community outreach program in

Newfoundland, Canada, as a hygienist, working with poor children, I knew I could

do more to help people as a dentist. I decided to go to dental school. I graduated

from Loyola Dental School in 1985 and completed a general dentistry residency and

fellowship program at Northwestern Memorial Hospital Dental Center. Later, I became an Assistant Clinical Professor in Dentistry at Northwestern Memorial Hospital Dental Center where I practiced until 1994. In addition to dental patient care,

I was an infection control officer.

During my early years of practice, AIDS emerged as a national health problem.

The Center for Disease Control mandated universal precautions to protect the practitioner and the patient from blood-borne pathogens. The use of latex gloves, glasses,

and masks as well as protective clothing, became the standard of care. Dentists all

over the country washed and gloved their hands between every patient. In the dental center where I practiced, latex gloves were snapping off and on constantly as

dentists, hygienists, and dental assistants moved from patient to patient.

I noticed blister-like formations on the backs of my hand when I used latex gloves.

My hands were always red, and a rash would appear within 24-hours of wearing

latex gloves. The rash forced me to change to non-latex gloves. Even though I had
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no direct contact with latex, I developed labored breathing, wheezing, itchy swollen

eyes, and asthma when others used powdered latex gloves in my presence. My

shortness of breath, coughing, and labored breathing lasted for several hours after

work. I needed inhaled bronchodilators to help me to breathe.

I was forced to retire in June of 1997 when a leading latex allergist diagnosed

me as having Type I Ig–E cell-mediated latex allergy after a skin prick test for latex

allergy was performed. The allergist explained that the skin rashes experienced earlier were evidence of a Type IV allergy to latex. He explained that continued exposure to airborne latex from powdered gloves even after I stopped using latex gloves

myself, caused the conversion to Type I (immediate hypersensitivity) latex allergy.

My choices were very limited. I was to avoid latex and its dust to save my life. With

a deep sense of loss, I retired from my dental profession.

Today, I know I am not alone. There is an epidemic of latex allergy emerging. Scientific literature estimates the prevalence of latex allergy among healthcare workers

to be between 8 percent to 17 percent, and between 1 percent to 6 percent in the

general population. One study sponsored by the American Dental Association

Health Foundation estimated average prevalence among dental professionals to be

6.2 percent based on a health-screening program in 1994 and 1995. The American

Dental Association has not released latex allergy data from this study for the subsequent years 1996, 1997, 1998, and 1999 so it is difficult to ascertain whether the

prevalence is increasing or declining among this group of dental professionals. The

American Dental Association refuses to disclose this current prevalence data on

latex allergy.

Today, I know powdered latex gloves produce ‘‘secondhand latex exposure’’ similar

to the secondhand smoke phenomena seen in the tobacco industry. The Food and

Drug Administration in 1997 issued a report on glove powder stating that the latex

protein can bind with glove powder and become airborne causing respiratory allergic

reactions in latex allergic individuals and ‘‘may represent an important agent sensitizing non-allergic individuals.’’ An article in the Journal of the American Medical

Association in 1997 stated: ‘‘Since the institution of universal precautions, latex

glove protein has emerged as a major allergen in health care facilities. Airborne exposure of health care workers to latex protein allergens may be increased by the

use of powdered gloves compared with non-powdered gloves.’’

The National Institute for Occupational Safety and Health Alert in 1997 and the

Occupational Safety and Health Administration Technical Information Bulletin in

1999 on latex allergy have sought to shed light on this emerging health problem

and to offer preventive strategies in the workplace. The American College of Allergy,

Asthma, and Immunology launched a nationwide campaign to educate healthcare

workers and other high-risk groups like spina bifida patients, individuals who have

had multiple surgical or medical procedures, to the risk inherent in latex.

The Allergy Report from the American Academy of Allergy, Asthma, and Immunology of March 2000 reported: ‘‘The increasing prevalence of latex allergy is related

to more frequent use of latex gloves resulting from universal precautions and

changes in the manufacturing process.’’ The Allergy Report also stated: ‘‘During the

past five years, increasing evidence has accumulated that latex allergy has become

a major occupational health problem, which has become epidemic in scope among

highly exposed healthcare workers, and in others with significant occupational exposure.’’ With all of these people affected with latex allergy, there are still many questions left unanswered. We need research for all areas of latex allergy including its

prevention, immune mechanism, disease progression, and the long-term outcome of

latex allergic patients.

Latex allergy is a life long, life threatening condition. The biggest risk is

anaphylactic shock—a life threatening condition resulting in hives, severe swelling

of the eyes, mouth, lips, and tongue as well as difficulty breathing, severe chest

tightness, and potentially, respiratory failure. Since 1989, the Food and Drug Administration has received reports of 15 deaths due to latex enema cuffs. During the

past ten years, the Food and Drug Administration has received over 2,000 reports

of adverse events involving latex gloves. Five deaths were included in these reports,

in addition to the fifteen deaths previously reported. There is no treatment, no cure

for latex allergy.

I live a life of avoidance. All I can do is avoid all latex products that may be inhaled, ingested, or touched. This presents a sizable challenge for all latex allergic

patients and me since there are over 40,000 products that contain natural rubber

latex. I avoid paramedics, hospitals, doctor’s offices, and dental offices that use latex

gloves and latex medical equipment. An accidental or inadvertent exposure with

latex can push me into anaphylactic shock so I carry with me two epinephrine

injectable pens, latex-free gloves and latex free emergency medical equipment. A

hospital emergency room or an ambulance where latex gloves have been used can
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be a real threat to me. In my community, police officers and paramedics arrive on

an emergency scene already wearing latex gloves.

Access to safe medical care is impossible for the latex allergic patient when latex

gloves and latex medical equipment are all that is available. There is no time in

an emergency medical situation to determine whether a patient is latex allergic.

There are safe and affordable latex alternatives that offer protection from bloodborne pathogens for the patient and the healthcare deliverer. Latex-free products

should be the standard of care for the emergency medical service, fire fighters, and

law enforcement.

I want to ask for your help in financial support for awareness, for education, and

for research into all aspects of latex allergy. Research is desperately needed to formulate a multi-disciplinary approach to latex allergy prevention involving hospitals,

public health departments, emergency medical systems, government regulatory

agencies, and manufacturers. Research is desperately needed to develop treatment

models for those who suffer from this emerging public health problem. Finally, research is desperately needed to determine the best means of educating employers

and employees to phase out latex gloves from work settings and tasks that do not

involve contact with infectious material. There is widespread and indiscriminate use

of latex gloves in non-medical industries such as food handlers, daycare workers,

auto mechanics, housekeeping personnel, and hair stylists.

PREPARED STATEMENT OF THE PANCREATIC CANCER ACTION NETWORK, INC.

Mr. Chairman and Members of the Subcommittee. My name is Paula Kim, I am

the Co-Founder & Chairman of the Board of the Pancreatic Cancer Action Network

or ‘‘PanCAN’’. In March of 1998, my father died from pancreatic cancer—a mere 75

days after diagnosis. Watching the devastation of this disease first hand, and encountering a severe lack of information, scientific progress and advocacy support,

sparked my desire in 1999 to co-found PanCAN. PanCAN is a non-profit organization and the first and only national patient based advocacy group for pancreatic cancer. Our staff of three is also fueled by grass roots volunteers across the country

focused on creating awareness and eradicating pancreatic cancer.

BACKGROUND

Increased emphasis on and awareness about pancreatic cancer is a good idea for

several reasons. First, there is currently no early detection method for pancreatic

cancer. Second, treatment options are severely limited and generally palliative. The

term ‘‘palliative’’ is what doctors say when they try to make someone comfortable

while he or she is dying from a disease. Third, there is an extreme shortage of

trained investigators working specifically on pancreatic cancer research.

Pancreatic cancer is one of the most aggressive cancers and has one of the lowest

survival rates among all cancers. Pancreatic cancer is the 4th leading cause of cancer death for men and women in this country. About 29,000 Americans are diagnosed with it each year, and nearly the same number die each year from this horrible disease. The incidence of the disease among African Americans remains disproportionately high. The typical pancreatic cancer patient has vague symptoms,

presents with metastatic disease and has a life expectancy of less than one year following diagnosis.

Our nation’s experience in dealing with AIDS, breast cancer and prostate cancer

has shown us that a focused effort and targeted funding can have an enormous impact on combating a specific disease. Pancreatic cancer has not attracted much interest because so many of the people most familiar with it are in cemeteries and

because the research funding has been the lowest funded per mortality of all major

cancers.

These facts, along with the recently completed National Cancer Institute (NCI)

Progress Review Group Report for Pancreatic Cancer, clearly identify the overdue

and desperate need to accomplish the following: develop Centers of Excellence, recruit and train investigators, develop public and professional education about the

disease, support research that identifies new methods of detecting and treating pancreatic cancer, and provide patient support and information services.

On behalf of PanCAN and the thousands of pancreatic cancer victims and their

loved ones, I summon your help and seek to impress upon you that ongoing emphasis and action is needed to address the magnitude and urgency of this disease. In

order for the research community to make progress on battling pancreatic cancer,

we must first get them to the starting line. Your consideration of our recommendations will help facilitate this process, and we are extremely grateful for your support.
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FISCAL YEAR 2002 NEED

For fiscal year 2002, we urge your support in promoting the specific actions with

the following Federal agencies:

National Cancer Institute

We commend the National Cancer Institute (NCI) for its report on the Pancreatic

Cancer Progress Review Group. This report is an agenda for action to attack pancreatic cancer. Pancreatic cancer is the 4th leading cause of cancer death for men

and women.

However, we remain concerned that while there are over 29,000 new cases of pancreatic cancer each year, 28,900 people die each year from this disease. It is one

of the most fatal forms of cancer but is one of the lowest funding priorities at NCI.

We seek your support to direct the NCI to develop, and present to the Congress

within six months, a professional judgment budget in line with the NCI Progress

Review Group for pancreatic cancer research for fiscal year 2003–fiscal year 2008.

In addition, we seek your support to direct the NCI to develop an initiative for the

awareness of pancreatic cancer that includes both scientific and lay materials to disseminate, thus helping to increase public and research awareness about this tragic

disease. Also, we would request that NCI consult closely with the research community, clinicians, patient advocacy groups and Congress in the preparation of this report.

National Institute of Diabetes & Digestive & Kidney Diseases

We seek your support to urge the National Institute of Diabetes and Digestive

and Kidney Diseases (NIDDK) to collaborate with the National Cancer Institute on

mutual research areas and awareness programs for the scientific and lay communities. We specifically seek your support in directing the NIDDK to establish

translational research activities to understand the inter-relationships of pancreatitis, diabetes, and pancreas cancer.

Centers for Disease Control and Prevention

We seek your support to encourage the Centers for Disease Control (CDC) to work

with the National Cancer Institute to determine possible areas of collaboration in

epidemiology, translational research, and awareness and registry programs. We

would further request that you direct the CDC to report back to you on initiatives

in these areas when they testify before Congress next year.

It would be most beneficial if the CDC would also plan and implement awareness

programs for orphan cancers for patients and community oncologists. Patients diagnosed with these cancers, such as esophageal, kidney, liver, multiple myeloma, pancreatic, and stomach, currently have lowest life expectancy rates of all diagnosed

cancers, yet community oncologists generally lack specific knowledge about these

malignancies. We suggest that the CDC develop comprehensive community

oncologist education programs to help doctors better identify orphan cancer symptoms and make more accurate, timely diagnoses.

Because pancreatic cancer adversely affect ethnic minorities and the medically

underserved, we suggest that the CDC to determine the feasibility of integrating

hematological (leukemia, lymphoma, multiple myeloma), digestive system (liver,

pancreatic), and genitourinary (kidney, genital) cancers screening and awareness

programs into existing activities.

Lastly, we would encourage the CDC registries program to establish, along with

the states, high-risk registries for the digestive cancers (liver, pancreatic) and other

cancers with significantly low survival rates following diagnosis.

CLOSING REMARKS

Mr. Chairman and Senators on the Subcommittee, thank your for allowing me

this opportunity to outline specific action steps which our Federal agencies may take

to further increase the awareness about pancreatic cancer and accelerate efforts to

eradicate this terrible disease. I have attached draft legislative language for your

consideration so that the recommendations outlined above may be incorporated in

the Fiscal 2002 Labor/HHS/Education Appropriations report.

Best wishes and good health to each of you.

PREPARED STATEMENT OF THE PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS

Chairman Specter and Members of the Subcommittee: People for the Ethical

Treatment of Animals (PETA) is the world’s largest animal rights organization, with

more than 700,000 members. We greatly appreciate this opportunity to submit testi-
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mony regarding fiscal year 2002 appropriations for the National Institutes of

Health. Our testimony will focus on nicotine experiments on animals.

Studies on human beings have documented the effects of smoking on disease processes, organ systems, longevity, and other health issues. Conducting nicotine experiments on animals is duplicative, meaningless, and wasteful.

We would like to request that the subcommittee include report language ensuring

that no funds under the appropriations act shall be used for nicotine or tobacco experiments on non-human animals.

In fiscal year 1996, the National Institutes of Health funded 123 grants totaling

$28,099,418 for research primarily concerned with cigarette smoke or nicotine. Forty

percent of these grants (49 of the 123) involved non-human animals. As you know,

funding is limited for medical research and health programs. Why waste American

tax dollars on nicotine experiments on animals when those funds could be much better spent on prevention programs, public education, or clinical studies?

CURRENT AND ONGOING NICOTINE EXPERIMENTS ON ANIMALS FUNDED BY THE

NATIONAL INSTITUTES OF HEALTH

Pregnancy studies

In his abstract entitled, ‘‘Fetal nicotine exposure effect on primate lung,’’ researcher Eliot R. Spindel writes, ‘‘The deleterious effects of maternal smoking during pregnancy are all too well established,’’ including ‘‘overwhelming evidence that

smoking during pregnancy directly and adversely affects lung development.’’

However, ‘‘overwhelming evidence’’ did not stop Spindel from applying for and receiving a four-year grant from the National Institute of Child Health and Human

Development to conduct nicotine experiments on pregnant rhesus monkeys. In order

to ‘‘characterize the effects of chronic exposure to low levels of nicotine throughout

pregnancy on lung development and subsequent pulmonary function,’’ pregnant

monkeys were given doses of nicotine ‘‘consistent with that of smokers.’’ Afterwards,

the infants’ lungs were examined to determine the effects of chronic nicotine exposure on lung development and function.

Spindel hopes that his study will ‘‘provide an important tool in smoking control

and will begin to better explain the link between maternal smoking and altered neonatal respiratory function,’’ despite the fact that evidence already in existence has

failed to alter the ‘‘unfortunate prevalence of smoking during pregnancy.’’

Eliot Spindel is with the Oregon Regional Primate Research Center in Beaverton,

Ore. His project started in February of 1999 and is scheduled to conclude in January 2004. (Source: NIH Computer Retrieval Information on Scientific Projects, June

2000.)

The public health message that can be gleaned from this experiment—that pregnant women should not smoke—was already well established before these experiments began. From a public health standpoint, it is difficult to avoid the conclusion

that these experiments are, at best, costly and trivial. Experiments like these are

frightening, stressful, and ultimately fatal for the animals involved. If helping

human babies is our goal, such experiments should be replaced with aggressive public health measures.

Addiction studies

In his abstract entitled, ‘‘Stress induced reinstatement of nicotine-seeking behavior,’’ James D. Valentine writes, ‘‘Many believe that stressful life events can contribute to drug use in humans, and, recently, animal models have been developed

for studying this phenomenon.’’

According to Valentine, ‘‘exposure to unavoidable stressors can dramatically affect

drug-seeking behavior, including relapse to drug-seeking in drug-free animals.’’

While a variety of ‘‘drugs of abuse’’ have been used to examine this phenomenon,

the ‘‘effect of unavoidable stress on nicotine-seeking behavior has yet to be examined.’’

As a result, Valentine applied for and received a grant from the National Institute

on Drug Abuse to, ‘‘determine if exposure to unavoidable stress will reinstate nicotine-seeking behavior in rats.’’

Valentine is with the Minneapolis Medical Research Foundation, Inc. His project

started in July of 1998 and was scheduled to conclude in June 1999. (Source: NIH

Computer Retrieval Information on Scientific Projects, June 2000.)

‘‘Unavoidable stressors’’ as mentioned above can involve a wide variety of obstacles, dangers, and painful experiences which the animals are forced to endure before

they are killed. Stressors in past nicotine experiments have included:

—placing animals on a hot plate heated to 126 degrees F;

—starvation until between 15 and 20 percent of the animal’s body weight is lost;
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—placing an animal in a large, deep tank filled with a paint and water mixture

(so that the animal cannot see what is beneath him). The animal’s task is to

struggle to find a clear Plexiglas ‘‘escape platform’’ below the surface on which

he can stand to keep his head above the liquid.

One has to question the value of Valentine’s experiment, as it has already been

well established that nicotine is a highly addictive substance, and there is little

doubt that rats would seek it just as they do cocaine, heroin, and other highly addictive substances. It would have been more helpful to society if this money had

been used to create addiction treatment programs for people for whom stress has

already ‘‘reinstated nicotine-seeking behavior.’’

Other examples

Here are two more examples of the numerous grants that NIH has bestowed for

nicotine experiments on animals.

A grant of $183,628 in 1996 was given to Hakan W. Sundell at Vanderbilt University to use nonsedated, mechanically ventilated lambs to see if ventilation effects of

nicotine exposure relate to SIDS in humans. (This grant was given despite our

knowledge that maternal smoking accounts for about 30 percent of all SIDS cases.)

A grant of $152,166 in 1996 was given to Leonard L. Howell at Emory University

to see how caffeine and nicotine interact in rhesus monkeys. Again, clinical studies

of human beings who smoke and use caffeine would be far more relevant.

SUMMARY

Nicotine experiments on animals cause immeasurable suffering and divert funds

from efforts that benefit human health, such as aggressive prevention, education,

and addiction treatment programs.

Please include language in the report accompanying the fiscal year 2002 LaborHHS-Education Appropriations bill stating that none of the funds under this appropriations act shall be used for nicotine or tobacco experiments on non-human animals.

If you do not feel that that would be possible, please consider including the following stipulations in the report:

If any of the funds under this appropriations act are to be used for nicotine or

tobacco experiments on non-human animals, the following criteria must be met before the experiments can begin:

—The secretary or administrator of the agency responsible for conducting the experiment shall provide a report to Congress with the following information:

—the purpose of the experiment and a description of its anticipated benefits to

human health;

—the number and species of animals required;

—the source from which the animal(s) will be procured;

—an explanation of why the number of animals cannot be reduced;

—a detailed description of what procedures the animal(s) will undergo;

—a rating (none, mild, moderate, or severe) and detailed description of the pain

and distress that the animal(s) will experience;

—a statement of whether or not analgesics or other painkillers will be used

(and if not, an explanation of why not);

—a description of all elements in the experiment considered to be stressors to

the animal(s);

—an explanation of what will happen to the animal(s) after the experiment is

completed;

—a list of all databases that were searched to ensure that the experiment is

not replicating any experiment(s) that has/have already been performed;

—a statement that, in the opinion of the secretary or administrator, there is no

possible way that the topic of the experiment could be researched without

using live animals, and an explanation of why this is, including an explanation of why this experiment would be more relevant to human health effects than human clinical studies or epidemiological studies would be;

—a description of any non-animal research methods that are currently under

development which may be a viable alternative to the experiment, and an explanation of why the experiment cannot be postponed until that non-animal

method becomes available for use;

—this report shall be published in the Federal Register for a 60-day period during

which the public may submit comments;

—this report, along with all public comments submitted during the aforementioned 60-day period, shall be reviewed by the House Appropriations Committee

and by the Senate Appropriations Committee. After reviewing the report and
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the public comments, a two-thirds majority in each committee must vote to approve the use of funds for the experiment.

If the above three criteria are not met, the funds may not be used for the experiment.

Without these stipulations, tax dollars will continue to be wasted on duplicative,

meaningless experiments that cause animals to suffer and that do nothing to benefit

human health.

Thank you for your consideration of our request.

PREPARED STATEMENT OF THE POPULATION ASSOCIATION OF AMERICA AND THE

ASSOCIATION OF POPULATION CENTERS

Thank you, Mr. Chairman for this opportunity to present the position of the Population Association of America (PAA) and the Association of Population Centers

(APC) to the Subcommittee on Labor, Health and Human Services and Education

on fiscal year 2002 funding for the National Institutes of Health (NIH), specifically

the National Institute on Aging (NIA), and the National Institute of Child Health

and Human Development (NICHD). You are a long-standing friend of both organizations. We are grateful to you for your recognition and support of demographic research.

As you know, PAA is a scientific and educational society of professionals working

in demographic research. APC is a consortium of 30 leading American population

research centers. In addition to their academic roles, members of both organizations

provide federal, state and local government agencies, as well as private sector institutions, with data and research to guide decision-making. Two population research

centers are based in Pennsylvania—one in Philadelphia and one in State College.

Demographic research covers many issues important to our nation, such as retirement, health disparities, disability and long term care, child care, immigration,

labor force participation, worker retraining, family formation and dissolution, and

population forecasting. The United States is undergoing far-reaching shifts in its demographic composition and distribution. Such changes are not always recognized or

understood until they confront society with new and immediate needs—often requiring federal and state expenditures. Incorporating demographic, social and behavioral research into long term policy discussions allow such changes to be tracked

and anticipated in a manner that promotes more coherent and efficient planning

and policy implementation.

The National Institute of Child Health and Human Development (NICHD) and

the National Institute on Aging (NIA) provide primary support for demographic research at NIH. We would like to take this opportunity to share with you information

concerning the implications of an aging population, the effects of welfare reform on

children and families, immigration, fatherhood and adolescent health.

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

NICHD has a well-established and successful population research program.

NICHD is currently funded at $977 million with approximately $74.5 million of that

budget dedicated to research funded through the Demographic and Behavioral

Sciences Branch in fiscal year 2000. Among the many areas of demographic research

supported by NICHD are families and household composition; marriage and family

change; fertility and family planning; teen pregnancy; mortality; HIV prevention;

and population movement, distribution and composition. NICHD also funds a highly

regarded population research centers program. Population research centers provide

a critical core of professionals who conduct research in a cost-effective manner. Further, the centers’ training programs are an essential source of population scientists

who bring fresh perspectives, ideas and improved methodologies to demographic research.

NICHD-supported demographic research provides important, ongoing information

critical to policymakers. We are pleased to provide information in this testimony

that focuses on the Fatherhood Initiative, the effects of welfare reform on children

and families, profiles of immigrants, and adolescent health.

Fatherhood

In the past, males were often overlooked in research that focused on family formation and functioning. NICHD, in conjunction with the Federal Interagency Forum

on Child and Family Statistics and the National Center on Fathers and Families,

launched a Fatherhood Initiative to review the capacity of the federal statistical system to conceptualize, measure and gather information from men about how they be-
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came fathers and how they provide economic and emotional support to their children.

Among the results of this effort are the inclusion of men in the National Survey

of Family Growth and the development of a father’s component in the Early Childhood Longitudinal Survey and the inclusion of basic research on fathers in the Early

Head Start Research and Evaluation Project. NICHD is also supporting research to

understand factors leading to stable unions among unmarried fathers and mothers.

The roles fathers play in the lives of their children are strongly affected by the

father’s relationship to the mother: the access of fathers to their children is highest

when parents are living together. The Fragile Families Study has found that unmarried fathers are generally engaged with their children at birth and aspire to be

good fathers, contrary to popular myth. Additionally, in cases of divorce, a NICHD

funded research has shown that many fathers have enormous desire to maintain

contact with their children, and with intervention can continue to be major influences in the lives of their children.

Welfare Reform Effects on Children and Families

The 1996 welfare reform act and the subsequent changes in the welfare programs

of nearly every state constitute the greatest shift in social policy for low-income families with children since the Social Security Act of 1935. Since the passage of welfare

reform legislation, welfare caseloads nationwide have dropped dramatically, yet we

know very little about how these changes affect these children and families. NICHD

supports a wide range of research that examines how communities, families and

children are interrelated and adapting to changes in social policy.

The Fragile Families and Child-Well Being Study started collecting data in 2000

and will continue through 2004. Initial waves of data will inform research on prenatal care, mother-father relationships, expectations about fathers’ rights and responsibilities, attitudes toward marriage, social support and knowledge of local policies and community resources. The Three Cities Study of Welfare Reform and the

Well-Being of Children studies the effects of the 1996 Welfare Reform bill on children in three cities, Boston, San Antonio, and Chicago, over the period 1999–2002.

Research on Immigration

Understanding the trends in immigration and the characteristics of immigrants

is vital for making informed policy decisions. NICHD, the Immigration and Naturalization Service (INS), the National Science Foundation (NSF), and the National

Institute on Aging (NIA) have cooperatively funded a New Immigrant Survey Pilot

Study (NIP). This study will provide immediate policy relevant information on immigrants in the U.S. and serve as the foundation for long-term research on immigrants.

Much of the conventional wisdom on immigrants has been repudiated in recent

NICHD supported studies. For example, legal immigrants are better schooled, on

average, than the native born; the proportion with postgraduate education is almost

three times larger than among the native born, at the same time, there is also a

substantial group without a high school education. Overall, however, the quality of

legal immigrants entering the U.S. is improving. Influenced by changes in immigration laws and changing economic conditions, the skill composition of immigrants to

the U.S. has risen.

Adolescent Health

Our knowledge of adolescent health has been greatly enhanced by the National

Longitudinal Study of Adolescent Health (Add Health), a comprehensive study,

begun in 1994, of adolescent health and well-being funded by NICHD and 17 other

federal agencies. This study provides information that is valuable to parents, educators, researchers and policy makers.

One of the key findings from the Add Health study is that ‘‘family-connectedness’’

plays a central role in protecting adolescent health: adolescents who feel loved and

cared for by their parents and are satisfied with their family relationships are least

likely to smoke, drink or use illegal drugs; least likely to become sexually active at

a young age; least likely to be emotionally distressed or contemplate suicide; and

least likely to engage in violence.

Family and Child Well-Being Research Network

We would also like to bring you up-to-date on NICHD’s Family and Child WellBeing Research Network—an interdisciplinary data system focusing on child- and

family-related research that relies on cross-agency cooperation. The network is comprised of scientists from nine universities collaboratively working with federal officials from NICHD, the Office of the Assistant Secretary for Health, of the Department of Health and Human Services (HHS), the Administration of Children and
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Families of HHS, the Census Bureau and the Department of Education. This network currently addresses a variety of questions about the interrelations between

parent characteristics, family structure and organization, neighborhood attributes

and different forms of social support. The network is committed to increasing the

visibility of basic research findings to those involved in formulating public policy.

Projects such as the Family and Child Well-Being Research Network perform the

important task of helping synthesize research into sensible policy solutions.

The Network, in cooperation with federal statistical agencies and the research

community developed a comprehensive set of indicators of child well-being. The information from these indices are compiled annually in the report ‘‘America’s Children: Key National Indicators of Well Being.’’ This report provides a much improved

information base that summarizes the changes in the overall well-being of American

children and families on an annual basis.

NATIONAL INSTITUTE ON AGING (NIA)

The NIA also has a well established and widely respected demographic research

program, which provides crucial information on the implications of an aging of the

American population for our country. Currently, the NIA is funded at $786 million,

with approximately $115 million of that budget dedicated to the Behavioral and Social Research Program—training, career development, and demographic, economic

and epidemiological research in fiscal year 2000. As the U.S. population ages and

Congress contemplates sweeping changes in Medicare and Social Security, the demography of the elderly steadily becomes more important. The NIA has a strong

history of supporting the collection of data, which allows demographers to study

questions of concern to policymakers. Chief among these is the NIA-supported studies, the Health and Retirement Study (HRS). You have been a solid supporter of

this important prospective panel study since its inception in the early 1990s, Mr.

Chairman, and we would like to express our gratitude for your support.

Health and Retirement Study (HRS)

The Health and Retirement Study (HRS) was launched in 1992 with baseline

interviews for a representative sample of persons born between 1931 and 1941.

These respondents were interviewed again in 1994, 1996 and 1998. Last year HRS

completed its most recent round of data collection, HRS2000 and even now is preparing to go back into the field in 2002.

In 1993, the HRS was augmented by the AHEAD (Asset and Health Dynamics

of the Oldest-Old) which sampled the cohorts born before 1924, individuals who are

the oldest-old segment of our population with high rates of chronic disease, disability, and health care costs. The older AHEAD respondents were interviewed in

1995, 1998 and 2000. In 1998, samples of two other cohorts were added, those born

between 1924 and 1930, the so-called children of the Depression, and those born between 1942 and 1947, or the ‘‘early baby-boomer cohort’’. With the addition of these

cohorts, HRS is nationally representative of the population over age 50. Since 1998,

the entire study is referred to as the HRS.

The original HRS focused on mid-life work and health dynamics. Biennial data

are now available for all respondents on health, disability, work, health insurance,

pensions and retirement plans, and transfers of time and financial help across generations of the family. The HRS has been used by NIA-supported researchers to explore issues related to health, work and retirement; mid-life savings and the prospects for late-life economic security; cognitive changes, health insurance coverage,

and use of health care services. Data provided by very old respondents has been

useful for studying how families redistribute their resources across generations, and

how these flows interact with public sector transfers. These data inform policy decisions on initiatives such as Medicare/Medicaid coverage for long-term care and prescription drug benefits.

Health Status and Health Care

We have long known that Americans are living longer than ever before, and new

research shows that older Americans are living better as well. A recent NIA funded

study showed that while memory problems increase with age, fewer seniors were

identified as having significant memory or cognitive problems in 1998 than in 1993.

Both men and women experienced improvements over the past decade and marked

improvements were seen in those over 80. These preliminary findings suggest that

severe cognitive impairment in the senior population has declined over time. This

study follows earlier studies which demonstrated a similar decline in the rates of

physical disability among the senior population.

The majority of Americans over age 65 rates their health as good or excellent and

report being satisfied with the health care they receive, still, many seniors face
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chronic health conditions or disabilities and utilize home care to help meet their

needs. While most home care is still provided informally and free of charge by family and friends, recent trends have shown a decline in the use of informal home care

as the sole means of help and an increase in the use of combined formal or paid

assistance and informal help. The 1990s saw dramatic increases in paid home

health care for older Americans. There are however a number of disparities in home

care assistance. Research has found that on average, disabled women receive significantly fewer hours of informal care than disabled men, and the dominant provider

is a child rather than the spouse, as it is for men.

Federal Forum on Aging Related Statistics

Finally, PAA and APC are interested in and support the current efforts to

strengthen the Federal Interagency Forum on Aging-Related Statistics. The NIA

leads the forum, which is a consortium of nine federal agencies working together

to improve the quality and usefulness of data on older Americans. The forum is an

example of NIA’s interest in supporting NIH’s innovative endeavor of streamlining

federal databases, making data accessible to the business community as well as academic researchers. Only by allying these two groups can the data produced by the

federal government be brought to bear on the real problems of older Americans.

CONCLUSION

PAA and APC would like to thank you for the opportunity to present this information. Demographic data and research are important tools for policymakers that can

both save public funds and promote more informed decision-making. If this vital research is to continue producing relevant and timely information, adequate funding

and Congressional support are needed.

The Population Association of America and the Association Population Centers

support an increase in the range of 15 percent to sustain the momentum of demographic research in the National Institutes of Health as part of the broadly based

support to continue five year process of doubling of NIH’s by 2003. PAA and APC

continue to support an even distribution of any increase in funding for NIH among

the institutes.

PREPARED STATEMENT OF THE PULMONARY HYPERTENSION ASSOCIATION

INTRODUCTION

Mr. Chairman, thank you for the opportunity to submit written testimony regarding fiscal year 2002 appropriations for the National Institutes of Health (NIH) and

the Centers for Disease Control and Prevention (CDC).

I am Linda Carr, president of the Pulmonary Hypertension Association (PHA).

Pulmonary hypertension is a rare disorder of the lung in which the pressure in the

pulmonary arteries (the blood vessels in the lungs) rises above normal levels and

may become life threatening. Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting.

When pulmonary hypertension occurs in the absence of a known cause, it is referred

to as primary pulmonary hypertension (PPH). This term should not be construed to

mean that because it has a single name it is a single disease. There are likely many

unknown causes of PPH.

Secondary pulmonary hypertension (SPH) means the cause is known. Common

causes of SPH are the breathing disorders emphysema and bronchitis. Other less

frequent causes are the inflammatory or collagen vascular diseases such as

scleroderma, CREST syndrome or systemic lupus erythematosus (SLE). Congenital

heart diseases that cause shunting of extra blood through the lungs like ventricular

and atrial septal defects, chronic pulmonary thromboembolism (old blood clots in the

pulmonary artery), HIV infection, liver disease and diet drugs like fenfluramine and

dexfenfluramine are also causes of pulmonary hypertension.

Pulmonary hypertension is frequently misdiagnosed and has often progressed to

late stage by the time it is accurately diagnosed. Pulmonary hypertension has been

historically chronic and incurable with a poor survival rate. However, new treatments are available which have significantly improved prognosis. Recent data indicate that the length of survival is continuing to improve, with some patients able

to manage the disorder for 15 to 20 years or longer.

As PHA’s new president, I come to this role standing on the shoulders of giants.

Ten years ago when three women with PH founded this organization, there were

less than 50 diagnosed cases of this disease. It’s not that PH wasn’t there, so much

as it was—for the most part—unknown, even in the medical community.
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Today, PHA includes:

—Over 3,600 patients, care givers and medical professionals

—An international network of over 50 support groups

—An active and growing patient hotline

—An new and fast-growing research fund

—A host of numerous electronic and print publications

Centers for Disease Control and Prevention

PHA applauds the subcommittee for its leadership in encouraging CDC to initiate

a professional and public PH awareness campaign in the fiscal year 2001 Labor,

Health and Human Services, and Education (L–HHS) conference report. Currently,

we are working with officials from the CDC to establish this important program

that will better inform health care professionals and the general public about PH,

its symptoms, and treatment options. The following is a description of the specific

initiatives we hope to launch in collaboration with CDC:

(1) Increasing awareness and understanding of PH among primary care physicians is critically important, because these practitioners are usually the first point

of contact for PH patients. If the primary care doctor misses the symptoms, then

the chance for early diagnosis depends upon the intuition and persistence of the patient. They have a chance, if they aggressively pursue diagnosis by trained and

aware specialists. If they are not aggressive, or if they are in a health plan that

requires their general practitioner to prescribe the referral, they are more likely to

go undiagnosed until it is too late to control their illness.

We are in the process of developing and implementing several targeted strategies

for reaching these providers, including:

—Written and video diagnostic tools for placement on the Internet.

—A postcard mailing to be sent to all primary care physicians, medical schools

and medical centers in the United States drawing attention to the new web resources.

—A simplified and visually attractive version of the proper diagnostic procedures,

which will be sent in a second mailing to all primary care physicians, medical

schools and medical centers in the United States.

—Advertising in publications general practitioners are likely to read. The emphasis will be the urgency and ease of early diagnosis and the ease of accessing

diagnostic tools via the Internet.

—A CD–ROM that explains pulmonary hypertension from a variety of angles. We

would like to make 100,000 of these available to the medical community and

patients through our web site on an as requested basis and at conferences and

through targeted mailings.

(2) Due to the advancements in treatment for PH, it is important that we also

focus on educating cardiologists and pulmonologists. Our strategies for reaching cardiovascular specialists include:

—Publication of the first Pulmonary Hypertension Journal focused on educating

a wider population of doctors on issues related to the diagnosis and treatment

of the illness.

—Placement of additional detailed information on the illness on the web. The PH

Journal and other publications will promote this availability.

—Expansion of PHA’s international conference on pulmonary hypertension (the

largest PH conference in the world).

—Expansion of PHA’s Pulmonary Hypertension Resource Network. This program

is focused on increasing awareness of PH among nurses through peer education.

(3) Finally, PHA is committed to increasing PH awareness among the general

public through the development of the following initiatives:

—A series of 10, 15 and 30 second public service announcements on PH. These

PSAs will be in both audio and video form.

—A PH media relations manual.

—An organ donation awareness campaign (unfortunately, many PH patients die

before finding a suitable organ donor).

—Expansion of PHA’s web-site.

We look forward to working with CDC to implement these and other initiatives

aimed at increasing awareness of PH in the United States and throughout the

world. For fiscal year 2002, we encourage the subcommittee to continue to support

the important mission of the CDC with an overall appropriation of $5 billion (an

increase of $1.1 billion over fiscal year 2001) Moreover, we urge you to provide $1

million (level funded from fiscal year 2001) within CDC’s Cardiovascular Disease

program (a division of CDC’s Chronic Disease Prevention program) for the continuation of the PH public and professional awareness initiative.
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National Heart, Lung and Blood Institute

Mr. Chairman, PHA commends the leadership of the National Heart, Lung and

Blood Institute (NHLBI) for its support PH research. Just last year, two separate

groups of scientists funded by NHLBI simultaneously identified a genetic mutation

associated with primary pulmonary hypertension.

The two groups, independently reported that defects in the BMPR2 gene, which

regulates growth and development of the lung, are associated with PPH. The defects

in the gene lead to the abnormal proliferation of cells in the lung characteristic of

PPH.

Although both studies suggest that only one gene is involved in PPH, neither

group identified the defects in BMPR2 as the sole cause of PPH. In addition, since

many people without a known family history of PPH get the disease, both groups

suggested that other factors may interfere with control of tissue growth. Now that

we have pinpointed a gene, we can focus on learning how it works. Hopefully, that

information will enable researchers to devise better treatments and perhaps eventually a preventive therapy or cure.

Mr. Chairman, PHA would like to thank you and the subcommittee for your leadership in support of funding for the National Institutes of Health. Moreover, we

would like to thank the subcommittee for the inclusion of committee recommendations on PH research at NHLBI in the fiscal year 2002 Senate L–HHS report. For

fiscal year 2002, PHA joins with the Ad Hoc Group for Medical Research Funding

in supporting a 16.5 percent increase for NHLBI. Finally, we request that the subcommittee provide $25 million in fiscal year 2002 for PH research at the institute

to enhance basic research, gene therapy and clinical trails of promising new therapies.

CONCLUSION

Mr. Chairman, once again thank you for the opportunity to present the views of

the Pulmonary Hypertension Association. We look forward to continuing to work

with you and the subcommittee to improve the lives of pulmonary hypertension patients. If you have any questions or would like additional information please do not

hesitate to contact me or the PHA National Office in Silver Spring, Maryland (301)

565–3004.

PREPARED STATEMENT OF THE RESEARCH SOCIETY ON ALCOHOLISM

The Research Society on Alcoholism appreciates the opportunity to present its

views about the importance of alcohol research within our nation’s priorities for

health and improving the quality of life. The Research Society on Alcoholism is a

professional society of over 1,200 members who are committed to understanding and

intervening in the negative consequences of alcohol through basic research, clinical

protocols and epidemiological studies.

The cost of alcohol abuse and dependence on American society and individual lives is staggering. The cost to the nation is estimated at approximately $185 billion annually. Not only are the fiscal costs real and powerful, but alcohol misuse is costly

in other ways as well. Specifically, it is associated with 50 percent of all homicides,

40 percent of all motor vehicle fatalities, 30 percent of all suicides and 30 percent

of all accidental deaths. Furthermore, the cost to productive life is astounding. A

recent review of estimates of Disability—Adjusted Life Years (a means of estimating

loss in productive daily living) indicates that alcohol abuse and dependence is the

fifth leading cause of lost life-years in the United States. It follows conditions which

are not unrelated from alcohol abuse and dependence such as ischemic heart disease, traffic collisions, certain cancers and HIV/AIDS. For some subgroups, such as

the American Indians with whom I work, the costs associated with alcohol misuse

may be even higher and may be directly linked to some of the major health problems in this group such as hypertension and diabetes.

Despite, or perhaps because of, the widespread impact and effects of alcohol, it

has been impossible to identify a single cause or solution to alcohol’s negative consequences. There is no doubt that alcohol abuse and dependence are affected by a

number of factors including genetic risk, socio-cultural characteristics, psychiatric

and general health co-morbidity and individual differences in the acute and chronic

effects of alcohol. The only hope for better understanding and thus more effective

education, prevention, intervention, treatment and long-term recovery is through research.

The Research Society on Alcoholism wants to thank the Congress, and this Committee in particular, for the strong support the National Institute on Alcohol Abuse

and Alcoholism (NIAAA) received in current fiscal year. Because of this committee’s
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historic support of the growth of biomedical research, and the investment in NIAAA

more specifically, the alcohol research community has made tremendous strides in

clarifying many of the factors which we now know contribute to risk to alcoholism

and the overall negative consequences of alcohol abuse and dependence. Specifically,

because of this support we have seen significant advances in disentangling the genetic influence and role of family history in alcohol dependence, we have begun to

identify the critical components of effective treatment, and we have begun to explore

effective integrated treatments for those who suffer from the most severe forms of

the disease. Given our scientific understanding of alcoholism only a few decades ago,

this is truly remarkable progress.

While recognizing these advances, we believe the need to continue the effort and

national commitment to this issue. The leadership of the Research Society on Alcoholism has framed a set of priorities which, if adequately supported, will move the

field significantly forward in all areas of NIH priority.

Specifically, we strive to more accurately evaluate risk for alcohol dependence and

measure the effectiveness of early education and primary prevention efforts. In regard to treatment, we are moving toward a systematic evaluation of integrated

treatments which engage more traditional therapies, the use of pharmacotherapies

(such as naltrexone) and the use of support and self-help groups. This focus does

not imply that all alcoholics require this level of treatment, but it is important that

we develop more effective treatments and develop means of identifying those who

are most in need of these interventions. Newer pharmacotherapies are now available which significantly decrease drinking and increase sobriety while still newer

medications (e.g., acamprosate; now under study) appear to reduce craving and thus

enhance the newly recovering person’s ability to sustain abstinence.

Technology has its place in these identified priorities, as well. Imaging and computerized testing will provide the means for understanding the underlying brain

systems and enable a more standard assessment across research protocols. Relatedly, the developing imaging techniques will facilitate our understanding of ‘‘craving’’ and provide the means for its characterization as the ‘‘brain event’’ that it is.

Basic studies of alcohol metabolism with specific subgroups continues to be a critical area for study. Additionally, neuroimaging studies including brain electrophysiology, positron emission tomography and developing technologies will shed

light on new ways of conceptualizing the disease process of alcohol dependence and

facilitate the distinction between alcohol abuse and dependence.

The Human Genome project as well as the Consortium on the Genetics of Alcoholism Study (the latter funded by NIAAA) have turned our nation’s attention to

the role of genes and the possibility of discovery. Alcoholism will not easily lend

itself to a simple genetic application. It can, however, be better described, the

subtypes better identified and the differential risk for various interactions between

alcohol and other medical disorders better clarified through these technologies.

Finally, we endorse the concern regarding health disparities as it is experienced

in the research of substance abuse and dependence. We know that there appears

to be an increased risk within certain ethnic/racial groups, however, it is unclear

why this risk exists and whether or not the risk applies to all members of the group.

For example, the Indian Health Service estimates that the age-adjusted alcoholism

mortality rate for American Indians is 63 percent higher than the rate for all other

races in the U.S. Initial studies with other racial groups have identified specific

strengths and vulnerabilities which are important to further explore if we are to address the needs of all Americans.

Recommendations.—Given the costs of alcohol abuse/dependence as well as the

significant advances over the past decade, we believe that the continued support of

NIH and NIAAA are imperative to our nation’s quality of life. Consistent with the

Ad Hoc Committee for Biomedical Research Funding, the Research Society on Alcoholism is urging that Congress support a $3.4 billion, or 16.5 percent, increase for

NIH in fiscal year 2002 to maintain the congressional campaign to double the NIH

budget by 2003. Within this funding level, the RSA requests a $79.4 million, or 23

percent, increase to NIAAA for fiscal year 2002; this increase would bring the total

NIAAA budget to $420 million. This request represents the professional judgement

of the alcohol research community and is justified on the basis of the historic under

funding of NIAAA, significant advances in recent years, and the promise of opportunity in the present.

The Research Society on Alcoholism thanks you for the opportunity to present our

views.
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PREPARED STATEMENT OF ROTARY INTERNATIONAL

Chairman Specter, Senator Harkin, members of the Subcommittee, thank you for

this opportunity to testify on behalf of Rotary International in support of the polio

eradication activities of the U.S. Centers for Disease Control and Prevention. The

effort to eradicate polio has been likened to a race—a race to reach the last child.

As in any race, discipline, commitment, and endurance are indispensable elements

of success. This race requires the discipline to remain focused on the task at hand.

We cannot allow ourselves to become complacent as we approach the finish line.

Though we sense victory is near, a single misstep could jeopardize all we have accomplished. This race requires the commitment to make the sacrifices necessary to

achieve success. The major partners in the global polio eradication effort have joined

with national governments around the world in an unprecedented demonstration of

commitment to this historic public health goal. As the initiative runs its course,

total victory can only be guaranteed through continued and unwavering commitment to the goal of a polio-free world. This race requires the endurance necessary

to maintain our current activities. We cannot allow the great distance we have traveled to diminish our resolve. Though we may be weary from a race that has now

lasted years, our adversary is weakening. The victory over polio is closer than ever!

I would like to take this opportunity to thank you Chairman Specter, Senator

Harkin, and members of the Subcommittee for your tremendous commitment to this

effort. Without your support of the CDC’s polio eradication activities, the battle

against polio would be impossible.

The global eradication strategy is working. In 1985, when Rotary began its

PolioPlus Program, 125 nations around the world were polio-endemic. At the end

of 2000, only 20 countries remained polio-endemic. The Western Hemisphere has

now been polio-free since 1991, and the Western Pacific region was certified poliofree in October of 2000. Europe will be the next block of countries to be certified

polio-free with the rest of the world anticipated to be certified polio-free not later

than 2005. Today polio is confined only to Sub-Saharan Africa, parts of the Middle

East, and South Asia (Exhibit A).

Thanks to the polio eradication efforts over the last decade, more than three million children who might have been polio victims are walking and playing normally.

Tens of thousands of public health workers have been trained to investigate cases

of acute flaccid paralysis and manage immunization programs. Cold chain, transport

and communications systems for immunization have been strengthened. A network

of 148 polio laboratories has been established.

Significant challenges lie before us. Continued political commitment is essential

in polio endemic countries, to support the acceleration of eradication activities, and

in donor countries, so that the necessary human and financial resources are made

available to polio-endemic countries. Access to children is needed, particularly in

countries affected by conflict. Truces must be negotiated if National Immunization

Days (NIDS) are to proceed in these countries. Polio-free countries must maintain

high levels of routine polio immunization and surveillance. The continued leadership

of the United States is critical if we are to overcome these challenges.

Rotary International is a global association of more than 29,000 Rotary clubs,

with a membership of over 1.1 million business and professional leaders in 163

countries. In the United States today there are some 7,500 Rotary clubs with over

380,000 members. All of our clubs work to promote humanitarian service, high ethical standards in all vocations, and international understanding.

In the United States, Rotary has formed the USA Coalition for the Eradication

of Polio, a group of committed child health advocates that includes Rotary, the

March of Dimes Birth Defects Foundation, the American Academy of Pediatrics, the

Task Force for Child Survival and Development, and the U.S. Fund for UNICEF.

These organizations join us in expressing our gratitude to you for your staunch support of the international program to eradicate polio. Over the past several years, you

have steadily increased your appropriation for the polio eradication activities of the

Centers for Disease Control, and for fiscal year 2001 you appropriated a total of

$91.4 million for the CDC’s overseas polio eradication efforts. This investment has

made the United States the leader among donor nations in the drive to eradicate

this crippling disease.

FISCAL YEAR 2002 BUDGET REQUEST

For fiscal year 2002, we respectfully request that you provide $106.4 million for

the targeted polio eradication efforts of the Centers for Disease Control and Prevention, a $15 million increase from the fiscal year 2001 funding level. This $15 million

increase is necessary to respond to the rising cost of oral polio vaccine, which has

increased to as much as $.096 from $.072 per dose. In addition, we must continue
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to meet the enormous costs of eradicating polio in its final stronghold—sub-Saharan

Africa. The underdeveloped and conflict-torn countries of Africa represent the greatest challenges to the success of the global Polio Eradication Initiative. This appropriation will allow the CDC to help African nations accelerate polio eradication activities, improve surveillance for polio and other diseases, and support peace-building cease-fires for National Immunization Days. Without the additional $15 million,

we may not be able to purchase sufficient levels of oral polio vaccine, prolonging the

need to continue expensive NIDs and routine immunization worldwide. The time for

the final assault against polio is now.

ERADICATING POLIO WILL SAVE THE UNITED STATES AT LEAST $230 MILLION ANNUALLY

In 1998 the Chairman of the House Committee on International Relations commissioned the General Accounting Office to investigate the soundness of WHO cost

estimates for the eradication or elimination of seven infectious diseases. The United

States was a major force behind the successful eradication of the smallpox virus,

and the GAO concluded that the eradication of smallpox has saved the United

States some $17 billion to date. Even greater benefits will result from the eradication of polio.

Although polio-free since 1979, the United States’ public and private sectors cur- rently spend at least $230 million annually to protect its newborns against the

threat of importation of the poliovirus, in addition to its investment in international

polio eradication. Globally, over $1.5 billion U.S. dollars are spent annually to immunize children against polio. This figure does not even include the cost of treatment and rehabilitation of polio victims, nor the immeasurable toll in human suffering which polio exacts from its victims and their families. Once polio is eradicated

and immunization against it can be discontinued, tremendous resources will be unfettered to focus on other health priorities.

PROGRESS IN THE GLOBAL PROGRAM TO ERADICATE POLIO

Thanks to your leadership in appropriating funds, the international effort to

eradicate polio has made tremendous progress.

—Since the global initiative began in 1988, more than 3 million children in the

developing world, who otherwise would have become paralyzed with polio, are

walking because they have been immunized.

—The number of polio cases has fallen from an estimated 350,000 in 1988—of

which 35,000 were reported—to approximately 3,500 reported cases in 2000

(Exhibit B). More than 180 countries are polio-free, including 4 of the 5 most

populous countries in the world (China, U.S., Indonesia and Brazil).

—Almost 2 billion children worldwide have been immunized during NIDs in the

last 5 years, including 150 million in a single day in India.

—Approximately 3,500 confirmed polio cases were reported to WHO for 2000. As

a result of routine polio immunization, NIDs and house-to-house mopping-up activities, there has been a 99 percent decline in reported polio cases since 1998.

—Of the three types of wild poliovirus, Type 2 has not been seen since October

of 1999, and appears to have been eradicated.

—All polio-endemic countries in the world have conducted NIDs. The achievement

of successful NIDs and implementation of APF surveillance in Somalia and

Sudan shows that polio eradication strategies can be implemented even in countries affected by civil unrest.

THE ROLE OF THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION

Rotary commends the CDC for its leadership in the global polio eradication effort,

and greatly appreciates your Subcommittee’s support of the CDC’s polio eradication

activities. For 2001, you appropriated a total of $91.4 million for the CDC’s global

polio eradication activities. Because of Congress’ unprecedented support, in 2001 the

CDC is:

—Supporting the international assignment of more than 110 long-term epidemiologists, virologists, and technical officers to assist the World Health Organization and polio-endemic countries to implement polio eradication strategies,

and 16 technical staff to assist UNICEF and polio-endemic countries. This includes 30 CDC staff provided directly on assignment to WHO and UNICEF.

—Providing nearly $50 million to UNICEF for approximately 530 million doses

of polio vaccine and $9 million for operational costs for NIDs in some 60 countries in Asia, Eastern Europe, the Middle East and Africa. A 33 percent increase in polio vaccine costs in 2001 has reduced the number of doses that can

be procured with CDC funds. Many of these NIDs would not take place without

the assurance of the CDC’s support.
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—Providing over $13 million to WHO for surveillance, technical staff and NIDs’

operational costs, primarily in Africa. As successful NIDs take place, surveillance has emerged as a critical need to determine where polio cases are continuing to occur. Good surveillance can save resources by eliminating the need

for extensive immunization campaigns if it is determined that polio circulation

is limited to a specific locale.

—Training virologists from all over the world in advanced poliovirus research and

public health laboratory support. The CDC’s Atlanta laboratories serve as a

global reference center and training facility.

—Providing the largest volume of both operational (poliovirus isolation) and technologically sophisticated (genetic sequencing of polio viruses) lab support to the

148 laboratories of the global polio laboratory network. CDC has the leading

specialized polio reference lab in the world.

—Serving as the primary technical support agency to WHO on scientific and programmatic issues regarding: (1) laboratory containment of wild poliovirus stocks

following polio eradication, and (2) when and how to stop polio vaccination

worldwide following global certification of polio eradication in 2005.

OTHER BENEFITS OF POLIO ERADICATION

Increased political and financial support for childhood immunization has many

documented long-term benefits. Polio eradication is helping countries to develop

public health and disease surveillance systems useful in the control of other vaccinepreventable infectious diseases. Already, much of Latin America is free of measles,

due in part to improvements in the public health infrastructure implemented during

the war on polio. The disease surveillance system—the network of laboratories and

trained personnel built up during the Polio Eradication Initiative—is now being

used to track measles, Chagas, neonatal tetanus, and other deadly infectious diseases. NIDs have been used as an opportunity to give children essential vitamin A,

as well as polio vaccine. The campaign to eliminate polio from communities has led

to increased public awareness of the benefits of immunization, creating a ‘‘culture

of immunization’’ and resulting in increased usage of primary health care and higher immunization rates for other vaccines. It has improved public health communications and taught nations important lessons about vaccine storage and distribution,

and the logistics of organizing nation-wide health programs. Additionally, the unprecedented cooperation between the public and private sectors serves as a model

for other public health initiatives. Polio eradication is the most cost-effective public

health investment, as its benefits accrue forever. The world will begin to ‘‘break

even’’ on its investment in polio eradication only two years after the virus has been

vanquished.

RESOURCES NEEDED TO FINISH THE JOB OF POLIO ERADICATION

The World Health Organization estimates that $1 billion is needed from donors

for the period 2001–2005 to help polio-endemic countries carry out the polio eradication strategy. Of this total approximately $550 million has been committed, leaving a funding gap of approximately $450 million. In the Americas, some 80 percent

of the cost of polio eradication efforts were borne by the national governments themselves. However, as the battle against polio is taken to the poorest, least-developed

nations on earth, and those in the midst of civil conflict, many of the remaining

polio-endemic nations can contribute only a small percentage of the needed funds.

In some countries, up to 100 percent of the NID and other polio eradication costs

must be met by external donor sources. We are asking that the United States continue to take the leadership role in meeting this funding gap.

The United States’ commitment to polio eradication has stimulated other countries to increase their support (Exhibit C). Belgium, Canada, Germany, and Italy

are among those countries that have followed America’s lead and made special

grants for the global Polio Eradication Initiative. Japan has also expanded its support to polio eradication efforts in Africa. Germany has made major grants that will

help India eradicate polio. In 1999 the United Kingdom announced two grants totaling U.S. $94.6 million for polio eradication efforts in India and Africa. In the last

year, the Netherlands has committed nearly $50 million for global polio eradication.

The Dutch Government pledged $8.4 million for surveillance in India, Pakistan and

the Democratic Republic of the Congo, followed by a year-end allocation of $40 million for surveillance in 2000.

By the time polio has been eradicated, Rotary International expects to have expended approximately $500 million on the effort—the largest private contribution

to a public health initiative ever. Of this, $402 million has already been allocated

for polio vaccine, operational costs, laboratory surveillance, cold chain, training and
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social mobilization in 122 countries. More importantly, we have mobilized tens of

thousands of Rotarians to work together with their national ministries of health,

UNICEF and WHO, and with health providers at the grassroots level in thousands

of communities.

Your discipline, commitment and endurance have brought us to the brink of victory in the great race against this ancient scourge. Polio cripples and kills. It deprives our children of the capacity to run, walk and play. Other great health crises

loom on the horizon. The work you have done and that which we ask you to continue will ensure that today’s children possess the strength and vitality to run the

race on behalf of future generations.

Thank you for this opportunity to present written testimony.
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PREPARED STATEMENT OF THE SCLERODERMA RESEARCH FOUNDATION

The Scleroderma Research Foundation appreciates the opportunity to submit this

written statement urging Congress to provide increased federal support to the National Institutes of Health (NIH) for the aggressive pursuit of basic research programs on scleroderma.

The Scleroderma Research Foundation has, on its own, mobilized and developed

a high quality scientific and medical research program dedicated to the pursuit of

a cure for scleroderma, all without government support. The advances made by the

Scleroderma Research Foundation have led to the identification of several key areas

of investigation that could further focus the path to a cure, if only the research receives the support it deserves. As this progress has developed, significant government help has been sorely lacking. A commitment from Congress and the NIH is

needed to leverage and build upon the key advances that have been achieved, and

to bring us closer to saving lives.

We ask for a commitment by Congress to provide concentrated federal support at

the NIH to aggressively pursue basic research programs on scleroderma. A goal of

$10 million annually would constitute a minute portion of total health research

spending, yet would more than double the current available funds for scleroderma

research. More important, this level of funding would support needed advances in

the current state of knowledge in the field.

The Scleroderma Research Foundation also calls for an appropriation of $23.7 billion for the NIH in fiscal year 2002. This 16.5 percent increase represents the fourth

step toward doubling the NIH budget by fiscal year 2003. This continued growth

will allow the NIH to realize the promise of new technologies and better meet the

challenges of improving the health of the nation’s people.

Scleroderma is a serious, but overlooked and under-funded disease. It is conservatively estimated to afflict at least 350,000 Americans (many organizations estimate

as many as 750,000 scleroderma patients in the United States, given recent advances in diagnostics). More than 80 percent of scleroderma patients are women, between the ages of 30 and 50, but scleroderma is also a disease that strikes—and

kills—children and men. Yet, the NIH is projected to fund scleroderma research this

year at only $4.74 million.

Scleroderma is a chronic, degenerative disorder that leads to vascular deterioration, tissue loss, and fibrosis in the body’s connective tissue. There are different
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types of scleroderma, but even in the disease’s limited forms, scleroderma can be

disfiguring, debilitating, and painful. In its most serious form, systemic sclerosis,

the disease causes severe damage and serious complications for the body’s digestive,

respiratory, circulatory, and immune systems. Almost 70 percent of patients with

systemic sclerosis die in less than seven years after their initial diagnosis.

A diagnosis of scleroderma is all the more chilling for patients when they learn

there are no effective treatments for the vast majority of cases and no cure for the

disease. Scleroderma has a particularly complex phenotype affecting different organs. The failure of a long list of medications in scleroderma patients points to the

critical need for basic scientific research to unlock the mysteries of this disease.

When the Foundation was created in 1987 there were no diagnostic tools for

scleroderma, and research on the disease was almost nonexistent. In a little over

a decade, the Scleroderma Research Foundation has successfully met the challenge

of raising pivotal funds, brought together top scientists to direct and execute cutting

edge, basic research programs and targeted the most direct approach to finding a

cure for scleroderma. The $5 million invested in research by the Scleroderma Research Foundation has all come from private sources, especially scleroderma patients, their friends, families and supporters.

The Foundation’s research programs have made critical discoveries in the three

major areas of pathogenesis of scleroderma: the immune system, blood vessels, and

extracellular matrix.

—Autoantibodies have been found that are unique to scleroderma patients and

are not found in other autoimmune diseases. Further research is needed to understand why and how these antibodies form.

—The study of blood vessel pathology has identified key receptors that mediate

the vascular hypersensitivity known as Raynaud’s phenomenon, a primary feature of scleroderma and a precursor to extensive vascular damage.

—Hardening of the skin, or fibrosis, is another prominent feature of scleroderma.

Investigators have identified a decrease in an inhibitory molecule that may explain the mechanisms leading to excessive hardening of the skin.

—New genetics studies have been initiated to determine if there are host factors

that can influence the onset of scleroderma. Advances in genetics present new

opportunities for scleroderma research, including the development of

scleroderma genotypes and the search for genetic mutations or aberrations.

These discoveries point the way to future investigations that cannot be carried by

the Scleroderma Research Foundation alone. We have made significant progress,

but have far to go in understanding this disease. We have made enough progress,

however, to know that scleroderma is a solvable problem. The Scleroderma Research

Foundation has been successful in bringing together the appropriate scientists in

specialized fields. The advances in molecular and cellular sciences have created tremendous potential, compared to ten years ago, for discovering the triggers of this

disease. Today, the right people and technologies are in place to cure scleroderma.

Your partnership is needed to secure the necessary resources to get the job done

and start saving lives.

Thank you for providing the opportunity to present this statement. The

Scleroderma Research Foundation welcomes any questions or requests for further

information.

PREPARED STATEMENT OF THE NATIONAL TASK FORCE TO END SEXUAL AND

DOMESTIC VIOLENCE AGAINST WOMEN

The Sexual Assault, Rape and Incest Issues Committee of the National Task

Force to End Sexual and Domestic Violence Against Women urges the Senate Appropriations Committee, Labor, Health, and Human Services, Education Subcommittee to appropriate the $80 million for Rape Prevention and Education Grants

authorized under the Victims of Trafficking and Violence Protection Act of 2000,

specifically:

Title IV—Strengthening Education and Training to Combat Violence Against

Women

Sec. 1401 Rape prevention and education.

Congress made a commitment by passing the Violence Against Women Act of

2000 to provide increased resources to sexual assault service providers and to continue and expand rape prevention programs. FULL FUNDING OF THIS GRANT

PROGRAM IS CRITICAL TO CONTINUING THIS IMPORTANT WORK.

The funds authorized under the Act are used for prevention and education programs for the following:

—Educational seminars
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—Operation of hotlines

—Training programs for professionals

—Preparation of informational material

—Education and training programs for students and campus personnel designed

to reduce the incidence of sexual assault at colleges and universities

—Education to increase awareness about drugs used to facilitate rapes or sexual

assaults

—Prevention/education efforts targeting underserved communities and individuals

with disabilities

Rape Prevention and Education funding also supports the National Sexual Violence Resource Center, a project of the Pennsylvania Coalition Against Rape. The

Center is a clearinghouse of information and resources related to all facets of sexual

violence, including stranger and non-stranger rape, drug-facilitated rape, statutory

rape, sexual harassment and child sexual abuse. The Center collects and facilitates

resource-sharing among organizations across the country. Every month, the Center

receives over 100 requests for information from state and territorial sexual assault

coalitions, local rape crisis centers, government entities, allied national organizations and the media.

Sexual violence is a critical social epidemic confronting our Nation:

An estimated 302,100 women and 92,700 men are forcibly raped each year in the

United States (Tjaden, Patricia and Thoennes, Nancy, November 1998).

13.3 percent of college women indicated that they had been forced to have sex in

dating situation (Johnson, I., Sigler, R., 2000. ‘‘Forced Sexual Intercourse Among Intimates’’).

In a 1998 study of which school students, over half of all males and 42 percent

of all females believed that sometimes it is ‘‘acceptable for a male to hold a female

down and physically force her to engage in intercourse’’ (Warshaw, 1998).

The majority of rapes nationwide are perpetrated against young women and girls.

Full funding of the Rape Prevention and Education grants is an indispensable tool

for keeping women and girls safe from sexual violence. Thank you for giving us the

opportunity to present our perspective.

PREPARED STATEMENT OF THE SJOGREN’S SYNDROME FOUNDATION

SJOGREN’S SYNDROME

Sjogren’s (SHOW-grins) syndrome is one of the most common autoimmune disorders, striking 4 million Americans. Ninety percent are women, and most are middle aged and older when diagnosed. However, Sjogren’s crosses all ages, ethnic

groups, and socioeconomic boundaries. Anyone can have this disease. There is no

cure and few treatments beyond palliative measures, yet the suffering and disability

is tremendous, and the potential consequences serious.

In Sjogren’s, the immune system turns against one’s own body. Moisture-producing glands are primary targets, resulting in hallmark symptoms of dry eyes and

dry mouth. These symptoms alone can be devastating. If not treated, dry eyes can

lead to corneal ulcers and abrasions and potential blindness. Untreated dry mouth

can lead to rampant cavities and loss of teeth. Once teeth are lost, those with

Sjogren’s have few options—dentures often don’t work in a mouth that’s dry and

susceptible to infection. Problems with swallowing, digestion, and reflux are also

common in Sjogren’s.

But Sjogren’s syndrome is not confined to symptoms of dryness. Sjogren’s can affect any organ in the body, including the skin, lungs, pancreas, and liver, endocrine

glands, and gastrointestinal, vascular, nervous, and urinary and reproductive systems. Autoimmune thyroid and autoimmune liver disease are not uncommon in one

who has Sjogren’s. Sjogren’s can cause debilitating joint and muscle pain and fatigue, and maternal antibodies associated with Sjogren’s can cause heartblock in babies of mothers who have the disease. Finally, Sjogren’s can result in

lymphoproliferative disorders, or lymphoma, there being a 44 times higher rate of

non-Hodgkins lymphoma in those who have Sjogren’s.

WHAT IS IT LIKE TO LIVE WITH SJOGREN’S SYNDROME

A Sjogren’s syndrome patient, Kim Vaughn, wants to tell you what it’s like for

her to live with the disease. She writes:

‘‘I’m a model, a former Mrs. Georgia America, and the mother of two energetic

boys. I’m a wife, a daughter, a sister. But what I know you can’t see if you were

to look at me is that I have a disease called Sjogren’s syndrome. This disease has

not only affected my life, but it has affected the lives of every member of my family.
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Sjogren’s syndrome is an autoimmune disease. While it can affect any organ in

the body, it targets the moisture producing glands. Can you imagine your eyes being

constantly dry because you can’t produce tears? Can you imagine what it’s like not

to have saliva, so that you can’t eat many common foods? Can you imagine being

so exhausted every night that you collapse at 8:00 p.m.? It’s hard enough to raise

two boisterous boys with a normal energy level.

I live with pain.—Joint and muscle pain are a big part of Sjogren’s syndrome. I

know it’s hard for people to understand the impact of pain and fatigue, and it might

seem minor to have dry eyes and dry mouth, but these symptoms are devastating.

To have your eyes and mouth dry all the time, be susceptible to infection, always

have to carry and use moisturizing eyedrops and drinking water wherever I go . . .

these things greatly affect quality of life.

I live with fear.—Will I be one of the 5 percent with Sjogren’s who gets lymphoma

and leaves a wonderful husband and kids behind, because this disease doesn’t seem

urgent or important enough? Because my symptoms can’t be seen? When I was

pregnant, I had to worry if my child would have fetal heartblock because of my

Sjogren’s. Would I have the energy to take care of an infant, to nurture a baby from

infancy to adulthood? Are my children genetically susceptible to this disease?

I was one of the lucky ones because I was diagnosed quickly—it only took a year

and a half. Sjogren’s might be a common autoimmune disease, but most women suffer for years before being diagnosed. When we’re finally diagnosed, there’s not much

to be done for it but treat the symptoms, many times ineffectively or only for a little

while. Why?

The Sjogren’s Syndrome Foundation greatly appreciates your continued support of

federally funded medical research. Please help us to take advantage, now, of the escalating breakthroughs in medical research to unlock the mysteries of autoimmunity—particularly the mysteries of Sjogren’s syndrome.’’

QUALITY OF LIFE

Quality of life might be hard to measure, but it is critical to one’s well-being, to

the ability to live a full life without potentially crippling psychological and physical

anguish and affecting employment and enjoyment of life.

Quality of life is surely compromised when one is frequently in pain and suffers

from severe fatigue, spends hours in doctors’ offices and undergoing testing, and

when one faces fear of complications. Other quality-of-life issues include having

one’s eyes and mouth hurt all the time and succumb to infection, not always being

able to focus clearly, swallow easily, go out to eat, or talk for long periods or take

a walk because one’s throat and mouth get dry quickly. The incidence of depression

increases when quality of life diminishes.

Most of the palliative treatments to which patient Kim Vaughn refers are overthe-counter medications, which are not reimbursable by insurance. This creates an

additional financial burden on those who suffer from Sjogren’s syndrome. High costs

of medical testing, frequent doctors’ visits to a range of specialists, and prescription

medications, might or might not be largely covered by insurance. Those who are

chronically ill face lifetime insurance caps and often find work options reduced.

Let’s take a look at the impact of just one of the common symptoms of Sjogren’s—

dry eye: A year 2000 study by Dr. David Sullivan of The Schepens Eye Research

Institute, Harvard Medical School, found that more than 37 percent of employed dry

eye patients say their symptoms interfered with their work and more than 60 percent say symptoms interfered with leisure activities. The same 60 percent say their

lifestyle has been adversely affected, and of these, more than 40 percent suffer from

depression. Some 40–45 million Americans, most of them women, have dry eye, and

the numbers double from those in their 50s to those 75 and older.

THE NUMBERS

Autoimmunity is a huge problem. Autoimmune diseases make up the third largest

disease category in the United States, affecting 5 percent of the population, and include some 70 to 80 diseases, many of which overlap and share symptoms. Sjogren’s

syndrome is one of the most prevalent.

The numbers of those with Sjogren’s syndrome are probably higher than scientists

estimate. It is often unrecognized and, thus, underdiagnosed and misdiagnosed.

Among the reasons—the disease crosses many medical specialties, symptoms often

seem unrelated, and Sjogren’s can mimic or co-exist with other autoimmune organspecific disorders. Dryness might be attributed incorrectly to the aging process.

Other complaints of fever, joint and muscle pain, and fatigue, and the waxing and

waning of symptoms are sometimes seen as insignificant to physicians not well informed about Sjogren’s syndrome. It often takes years of seeking help before a diag-
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nosis is made; a recent national health study showed an average of 6.3 years from

onset of symptoms to diagnosis. Add to this the fact that the baby-boomer generation is now entering the age of high risk for Sjogren’s, and the number of patients

will surely increase.

RESEARCH OPPORTUNITIES

Scientists still do not know the cause of Sjogren’s syndrome, but recent developments have taken us a step closer to understanding the disease and finding new

treatments. For example, inflammatory infiltrates have long been believed to cause

decreased tears and saliva in Sjogren’s, but new research shows there might be a

very different reason. The glands that produce moisture might, in fact, be rendered

dysfunctional by specific autoantibodies, antibodies that target one’s own self. These

antibodies targeting muscarinic receptors have been found to cause dry eyes and

mouth in animal models. Similar antibodies have been implicated in other Sjogren’s

complications, such as fetal heartblock in babies born to mothers with Sjogren’s.

Other new developments will enhance both clinical and basic Sjogren’s research.

The first is an agreement by an international committee of scientists working to develop standards for defining the disease, an effort organized and supported by the

Sjogren’s Syndrome Foundation.

Second is the potential for a registry on Sjogren’s and inclusion of Sjogren’s in a

database on autoimmunity. NIDCR is looking into the possibility of starting a database specifically on Sjogren’s, and NIAMS and NIAID already fund one for autoimmune disease, but Sjogren’s was not originally included. They are now working

with us on ways to do just that. If Sjogren’s is included in databases, we’ll be better

able to understand the genetics of Sjogren’s and autoimmune diseases and other aspects of autoimmunity.

We’re in a new information age, and it’s time we gathered data that will answer

the critical need for epidemiological studies on Sjogren’s. We have no statistics!

Finally, as an NIDCR scientific workshop held last fall on Sjogren’s demonstrates,

we can inspire groups of scientists from around the world to work together, develop

the means to share research, and expand our base of knowledge.

There’s a wonderful Sjogren’s Syndrome Clinic housed at NIDCR, and indeed,

most of the research on Sjogren’s is being done at the dental and eye institutes.

Sjogren’s syndrome crosses many specialties and encompasses systemic manifestations, and because of that, we would like to see NIAMS and NIAID become more

actively involved in this disease.

We rely on the National Institutes of Health (NIH) to help educate physicians and

the public. Our foundation and the NIDCR co-hosted a continuing education conference for healthcare providers this fall—the first one ever at NIH. NIDCR held

a scientific workshop at the same time, and NIAMS published its first information

booklet on Sjogren’s this year. These are wonderful, but these are only firsts. We

MUST continue and expand these initiatives.

We’re seeing an explosion in medical and scientific opportunity right now. We

have incredible opportunities ranging from immunology to cell biology, from drug

development to genetic engineering, through which genetic makeup might eventually be changed to actually block autoimmune disease. The human genome project

opens up new avenues for discovering the genetic links in autoimmune disease. We

have unprecedented opportunities for research in the areas of immunomodulation,

gene therapy, and creation of artificial glands. We MUST take advantage of this.

NATIONAL INSTITUTES OF HEALTH AND APPROPRIATIONS

Sjogren’s syndrome is one of the most prevalent autoimmune diseases. Yet, astonishingly, the prevalence does not match the low dollar figure spent on research and

education.

Sjogren’s syndrome ranks ninth when we compare the number of extramural

grants at the National Institutes of Health (NIH) for autoimmune disease. There

are twice as many clinical trials for lupus, another autoimmune disease, as are

being done for Sjogren’s syndrome, but Sjogren’s affects twice as many people.

The most recent figures available from the NIH Autoimmune Diseases Coordinating Committee show that out of an approximately $18 billion budget for NIH,

$398 million was allocated for autoimmunity. Yet autoimmunity is the third largest

disease category in the U.S. Of the total amount for autoimmunity, over 90 percent

went to just three autoimmune diseases—rheumatoid arthritis, juvenile diabetes,

and multiple sclerosis. Lupus received the next largest amount, leaving about $45

million for 76 other autoimmune disorders, including Sjogren’s syndrome.

We ask your committee as it works on the next Appropriations bill, to add the

words ‘‘Sjogren’s syndrome’’ any time another autoimmune disease is mentioned by
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name. Sjogren’s is one of the most prevalent autoimmune diseases, is an ideal scientific model, and yet over and over again it is left out.

We are working to change the visibility of and attention for Sjogren’s syndrome,

and we hope after our testimony, you, as members of the Subcommittee on Labor,

Health and Human Services, Education and Related Agencies, will recognize the importance of this disease.

We applaud you for supporting medical research at the NIH and working towards

doubling the NIH budget over 5 years. We applaud you for your support and allocation of dollars for autoimmunity. We are grateful for your support of the NIH Autoimmune Diseases Coordinating Committee. Finally, we urge you to consider research costs not just in dollars, but the human cost, the tremendous burden of disease on families, and especially the specific burden of a prevalent and devastating

disease—Sjogren’s syndrome.

HOW CAN THE SENATE APPROPRIATIONS SUBCOMMITTEE ON LABOR, HEALTH AND

HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES HELP

A first and important step by Congress was establishing the Autoimmune Diseases Coordinating Committee at the National Institutes of Health. But we would

like to see NIAMS and NIAID take on a larger role in the many systemic aspects

of this disease.

We ask that NIAMS and NIAID recognize that research in Sjogren’s syndrome is

part of their mission and should be included in their portfolio of grants.

PREPARED STATEMENT OF THE SUDDEN INFANT DEATH SYNDROME ALLIANCE

Chairman Specter, thank you for the opportunity to address this subcommittee

and explain what Sudden Infant Death Syndrome and the importance of federal

funding for SIDS programs and research means to me. My wife and I lost our son

Chandler in 1997, and we are compelled to do everything and anything possible to

ensure no one has to suffer the loss of a child again. Mr. Chairman, we need your

help, your commitment, and your support to help solve the mystery that is SIDS.

Despite the fact that SIDS cases have been documented for years, organized scientific research into SIDS only began in the mid 1970’s. Three decades later scientists are now beginning to make significant progress in unraveling the enigma of

SIDS. For instance, we now know that in many SIDS related deaths there is an abnormality in a region of the brain which is thought to control heart and lung functions. In these cases, this irregularity may have hampered normal respiratory activity, and while not the sole cause of SIDS, it may have contributed to a larger respiratory problem leading to death.

As a direct result of SIDS research and the ‘‘Back to Sleep’’ educational and

awareness campaign, SIDS deaths have been reduced by 38 percent since 1992, concurrent with the increase in awareness regarding infants being placed on their

backs to sleep-leading to the greatest decline in infant mortality rates in over 20

years.

However, our research and educational campaign is far from finished. Each year

more than 3,000 infants in the United States die from SIDS and it continues to be

the number one cause of death for children between one month and one year of age.

SIDS is a major component of the United States infant mortality rate. In spite of

this fact, we do not yet understand the causes of SIDS nor do we possess a guaranteed method for its prevention.

The primary federal agency responsible for conducting SIDS research and the

‘‘Back to Sleep’’ public awareness campaign is the National Institute of Child Health

and Human Development (NICHD) at the National Institutes of Health. In addition

to federal funding of SIDS research, there are other federal agencies involved in the

SIDS effort. Since 1975, the Maternal and Child Health Bureau (MCHB) within the

Health Resources and Services Administration (HRSA) has supported specific programs for SIDS family counseling and for public and professional education about

SIDS. The Centers for Disease Control and Prevention (CDC) has established a

standardized death scene investigation protocol for SIDS incidents. Additionally an

Interagency Panel on SIDS has been established, which includes: NIH, HRSA, CDC,

Indian Health Services, Food and Drug Administration, U.S. Consumer Products

Safety Commission, Department of Defense, Administration for Children and Families, and the Department of Justice to help coordinate all federally funded SIDS activities.

The SIDS Alliance is grateful for the Subcommittee’s past support of SIDS activities, especially the support of NICHD. We urge you again to provide the additional

funding necessary for the second year of the third Five Year SIDS Research Plan
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to ensure that NICHD can continue to address critical SIDS research initiatives.

Specifically the SIDS Alliance is supporting a funding increase to $23.7 billion or

16.5 percent for NIH overall, and a 16.5 percent increase for NICHD to $1.137 billion. We ask that the increases for NIH do not come at the expense of other Public

Health Service Agencies. Further research is essential to find the reasons for, and

means of preventing the tragedy of SIDS.

I urge the Subcommittee to support SIDS educational, awareness, and counseling

activities that take place at the MCHB, and the death scene investigation protocol

demonstration projects at the CDC. These programs are a vital ‘‘flip-side’’ to the

good research that NICHD does. Without prevention awareness, counseling, and

standardized investigation procedures, good research does not translate into meaningful advances for SIDS victims and their families.

HIGHLIGHTS OF FEDERALLY FUNDED SIDS ACTIVITIES

National Institute of Child Health and Human Development (NICHD)

Childcare has become increasingly important in the social fabric of the United

States, so have child care centers and homes. To address this issue the NICHD has

initiated the ‘‘Back to Sleep Child Care Project,’’ sending publications and other

‘‘Back to Sleep’’ materials to over 280,000 child care centers and licensed homes

throughout the United States. Response to these mailings has been overwhelming,

resulting in a 20 percent increase in the volume of requests for Back to Sleep materials.

Studies on the risk factors for SIDS among African American and American Indian populations conducted in collaboration with the CDC and the Indian Health

Service have yielded valuable information for targeted interventions to reduce infant

mortality in these communities. SIDS among minority populations continues to be

a top priority for the NICHD. Surveys show that the proportion of African Americans placing their infants to sleep on their stomachs continues to decrease, however,

African Americans are still twice as likely to place infants on their stomachs as compared to other populations. Discussion groups are underway in African American

communities across the country to assess the ‘‘Back to Sleep’’ campaign message,

and to improve message delivery. In addition, during fiscal year 2001, the NICHD

established new initiatives on health disparities in minority populations. SIDS and

related fetal and infant deaths are part of the initiatives targeted at eliminating

health disparities in infant mortality.

A new component of the ‘‘Back to Sleep’’ campaign focusing on reducing SIDS

among African American was launched in late 1999. The goal is to develop and implement a community-based initiative. The National Black Child Development Institute (NBCDI) joined with the NICHD, the campaign sponsors, and several other organizations in the outreach initiative. A culturally appropriate resource kit, which

includes a training guide, has been developed, and the first national training workshops have been held. Plans for fiscal year 2002 include training at the local level

through affiliate African American organizations, and regional infant mortality summits. In addition, discussions have begun for a community partnership campaign

targeted to reducing SIDS among American Indians in fiscal year 2002.

The mechanism of SIDS is still unknown; there are no clinical or biologic tests

to identify a newborn at high risk of succumbing to SIDS; and more work is needed

to increase the implementation of ‘‘Back to Sleep’’ among all caregivers and in communities with high rates of infant death. To address and focus its efforts on these

challenges, the NICHD is in the process of developing and implementing its third

SIDS Research Five-Year Plan. Meetings regarding various aspects of the five-year

plan have been held throughout the past two years and are expected to continue.

The plan will be divided into five parts: Introduction, Etiology/Pathogenesis,

Prognostics/Diagnostics, Prevention, and Health Disparities. A draft of the Introduction and the Etiology/Pathogenesis section will be open for public comment on the

web during the month of March 2001. The remainder of the draft plan will be on

the web for public comment in April.

Plans for research initiatives in fiscal year 2002 include (1) continued research on

mechanisms of pathogenesis through studies in animal models, postmortem tissue,

and high-risk infants. This includes a prospective study to define a battery of physiologic and genetic markers that will predict SIDS and to determine whether SIDS

is part of a larger family of autonomic nervous system disorders; (2) analysis of epidemiological and physiological data collected during the second five year research

plan to improve our understanding of environmental and intrinsic risk factors; (3)

a community-linked health disparities initiative to investigate related aspects of

mortality from late fetal life through early childhood; (4) improve risk reduction and
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efficacy of ‘‘Back to Sleep’’ through continued research, monitoring, and outreach in

at risk communities.

Maternal and Child Health Bureau (MCHB)

The MCHB supports a number of SIDS and Other Infant Death related services

and programs, including the following activities:

—National SIDS Resource Center, a major source of current information about

SIDS.

—Maternal and Child Health Service Block Grant (MCH), which grants funds to

states providing a range of services to SIDS families. Block grant funds support

activities like: contact families immediately after death, discussion of autopsy

results with the family, and support and counseling through the first year of

bereavement. Unfortunately, in many jurisdictions across the country, funds for

these services have been decreased or eliminated due to budgetary difficulties.

—Field training and curriculum to health care providers for case management of

families who have experienced an infant death, and the development of model

programs, particularly for the underserved and minorities. Demonstration

grants have been established in four states to target services for specific populations: California, Massachusetts, Missouri, and New York.

—National SIDS & Infant Death Program Support Center to address SIDS service

issues at the federal level on an ongoing basis. The SIDS Alliance was chosen

to run this center, which opened in 1999, and has experienced notable success.

Centers for Disease Control and Prevention (CDC)

To develop a better statistical figure on SIDS cases, Congress recommended in

1993 the establishment of a standard death scene protocol to offset discrepancies on

unexplained infant deaths between states. It was hoped that this protocol would be

adopted by states not only for statistical measure, but to help avoid awkward and

emotionally charged misunderstandings at the death scene. In 1996, CDC published

the protocol, and since that time several states have adopted the standard. It is

SIDSA’s long term goal to ensure that all states fully adopt the protocol. To help

realize this goal, SIDSA would like CDC to heed Congress’ recommendations for the

past two years and implement demonstration projects that follow these guidelines

in several communities nationwide. We would also encourage CDC to implement a

nationwide survey to measure how many locales have implemented the protocol

independently and to analyze the results thus far.

In conclusion, we are all too painfully aware that SIDS has historically been a

mystery, leaving in its wake devastated families and bewildered physicians. Not

only have there been no answers on the cause of SIDS, but there have been no answers on how to effectively prevent its occurrence. Today we are beginning to find

some of the answers on cause and prevention, and therefore reduce the risk of SIDS.

Because of the ‘‘unknown’’, however, babies are still vulnerable even when parents

and care givers take the cautionary steps to prevent SIDS deaths. This tragedy will

continue if research efforts are stalled or halted, especially when we are at the point

where so much progress has been made. Now is the time for a re-energized effort

against this tragic syndrome.

On behalf of the thousands of families who have been devastated by the loss of

a baby to SIDS, and the millions of concerned and frightened parents, we ask for

your support, and thank you again for allowing us to present this testimony. If you

have any questions, please do not hesitate to contact us.

PREPARED STATEMENT OF THE TRUST FOR AMERICA’S HEALTH

Mr. Chairman, and members of the Committee, I wish to provide a real perspective on our nation’s ability to respond to health emergencies like the pediatric leukemia cluster in Fallon, Nevada and health concerns related to multiple sclerosis

in Wellington, Ohio.

My name is Dr. Shelley Hearne and I serve as the executive director of the Trust

for America’s Health—a new nonprofit health advocacy organization taking action

to prevent disease and protect the health and safety of our communities. I am very

proud to have former Governor Lowell Weicker, Representative Louis Stokes, and

Chairman John Porter along with many other national leaders in public health

serve on our Advisory Council.

By way of background, I am an environmental health scientist—serving for almost

twenty years in government, non-profits, and as a faculty member of the Johns Hopkins School of Public Health. Most recently, I was the executive director of the Pew

Environmental Health Commission.
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Let me be candid. Our public health service is falling short in its duty to watch

over the safety and health of Americans, particularly when it comes to chronic diseases that may be associated with environmental factors.

Chronic diseases such as cancer, asthma, Parkinson’s, birth defects and diabetes

are responsible for 7 out of 10 deaths in this country. More than a third of our population, over 100 million men, women and children, suffer from chronic disease. By

2020, studies estimate that chronic disease will strike 134 million Americans and

cost $1 trillion a year. And the Centers for Disease Control and Prevention (the

‘‘CDC’’) estimates that 70 percent are preventable.

Despite the human and financial toll of chronic diseases on our country, we have

no national approach to track these diseases and respond effectively to cluster crises. Our federal, state, and local agencies only coordinate tracking and responding

to infectious diseases such as polio, yellow fever and typhoid—diseases that a national tracking and response system helped to eradicate back in the late 1800s.

Let me give you some examples of chronic disease clusters and concerns from

around the country and the problems we face in responding to them.

In Fallon, Nevada, twelve children have been stricken with an acute form of leukemia since 1997. This occurrence rate is higher than the expected average of this

disease in a town the size of Fallon. Residents as well as health officials suspect

that this cancer may be linked to environmental factors such as a high level of naturally-occurring arsenic in the water or possibly an infectious virus.

In my home state of New Jersey, between 1993–1997, parents in Brick Township

identified 53 cases of autism out of 6000 children between the ages of 3 and 10

years. For years, parents complained to politicians and health officials about a

feared autism cluster in their community. Health agencies are still trying to determine if this is a problem.

And in Wellington, Ohio, 25 citizens have been diagnosed with multiple sclerosis

(MS) in a town of 4,200. This rate is higher than the national average based on recent studies. Residents worry about the toxic exposures from a local iron foundry

and the nearby landfill.

In each case, our public health officials lacked the disease occurrence data, personnel, training, and lab capacity to detect these health emergencies and respond

to them.

Many chronic diseases are preventable, and each of the above mentioned clusters

and health concerns might have been a preventable tragedy. But, because we have

no coordinated national tracking of chronic disease, we are unable to identify disease clusters and respond quickly to these health emergencies. As a result, we are

hamstringing our scientists from finding solutions and effectively taking action—regardless if it’s childhood leukemia in Fallon or multiple sclerosis in Ohio.

Let me describe the existing status of our fractured state health tracking networks.

—Even though studies have shown that birth defects are the number one cause

of infant mortality, 17 states do not track birth defects—Pennsylvania, Ohio,

Mississippi, New Hampshire, Louisiana, Vermont, Rhode Island, Indiana, Minnesota, South Dakota, North Dakota, Wyoming, Montana, Idaho, Nevada, Oregon, and Washington.

—Only eight states and the District of Columbia track developmental diseases

such as cerebral palsy, autism and mental retardation even though the National

Academy of Science estimates that 25 percent of these diseases in children are

caused by environmental factors—California, Kentucky, Mississippi, Nebraska,

New Jersey, North Carolina, South Carolina, and South Dakota.

—Even though studies have shown autoimmune diseases like Lupus to be increasing, only four states report tracking this disease—Arizona, Massachusetts, New

Mexico, and South Dakota.

—For years most states did not track cancer. Tracking began in the early 1990’s

when the CDC allocated money to the states to start cancer registries. Uniform

standards for the state cancer tracking networks were just established in 1997.

—More than half of the states do not track asthma even though studies have

shown that asthma attacks are the number one cause of school absenteeism and

that asthma has increased 75 percent between 1980 and 1994.

The Pew Environmental Health Commission based out of the Johns Hopkins

School of Public Health studied ways to strengthen our nation’s public health defenses and proposed creating a Nationwide Health Tracking Network.

The Nationwide Health Tracking Network consists of five components:

Coordinating essential data collection systems.—The first component builds on existing health and environmental data collection systems and establishes data collection systems where they do not exist. The Network would coordinate with the local,

state and federal health agencies to collect this critical data.
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In all fifty states, the Network would track:

—Asthma and other respiratory diseases;

—Developmental diseases such as autism, cerebral palsy, and mental retardation;

—Neurological diseases such as Alzheimer’s, multiple sclerosis, and Parkinson’s;

—Birth defects; and

—Cancers, especially in children.

The Network also would track exposures to:

—Heavy metals such as mercury and lead;

—Pesticides such as organophosphates and carbamates;

—Air contaminants such as toluene and carbamates;

—Organic compounds such as PCB’s and dioxins; and

—Drinking water contaminants, including pathogens.

Developing an Early Warning System.—The second component is an Early Warning System that would immediately alert communities to health emergencies such

as lead, pesticide and mercury poisonings. The existing system of local health officials, hospitals and poison centers that alert our communities to outbreaks like food

illness and the West Nile virus would also warn our communities about these health

emergencies.

Creating Rapid Response Teams.—The third component consists of improving our

response time to identified disease clusters and other health emergencies. The Network would coordinate federal, state and local health officials into Rapid Response

Teams to quickly investigate these health emergencies, providing the teams with

the trained personnel and necessary equipment.

Addressing unique local health problems.—The fourth component is a pilot program consisting of twenty regional programs that would investigate local disease

clusters and emergencies outside of the Network. These programs would alert the

public and health officials to new developing disease clusters. These pilots programs

also would serve as possible tracking models to be included in the Network.

Creating community and academic partnerships.—The fifth component creates relationships with our communities and with regional academic centers. Community

relationships would ensure that the tracking data is accessible and useful on a local

level. The academic partners would assist with training the workforce, analyzing

data, and developing links between the tracking results and preventative measures.

[The background and basis for this Network and other Commission findings are

also available on the website at http://healthyamericans.org or http://healthtrack.org]

This Network would provide our communities, scientists, doctors, hospitals and

public health officials with the missing data on where chronic diseases are occurring

and whom they are striking. This basic, but yet critical, information would enable

us to develop effective prevention strategies to protect the health of our citizens.

Data from the Network will also allow us to spend our limited research dollars

more effectively by identifying which chronic diseases are increasing and where they

are clustering. We have doubled our research dollars in the National Institutes of

Health, yet these scientists do not have the most basic information about how often

and where chronic disease occurs. Without a Network, our scientists will remain in

the dark, unable to develop effective prevention strategies.

Developing prevention strategies for chronic diseases is critical to reducing the

$325 billion our country spends on these diseases. In less than fifteen years, the cost

of chronic disease is expected to rise to $1 trillion. The estimated cost of the Network is about $275 million or less than 1 dollar per every man, woman and child.

This is the most cost effective use of tax dollars today—investing in ways to prevent

the leading and most costly diseases in this country.

The public strongly supports the concept of nationwide tracking. A recent public

opinion poll by Princeton Survey Research Associates revealed that nine out of ten

(89 percent) registered voters support the creation of a national health tracking system. The American public is so concerned about this issue that 63 percent feel that

public health spending is more important than cutting taxes. Seven out of ten registered voters (73 percent) feel that public health spending is more important than

spending on a national missile defense system.

Over thirty key health organizations have endorsed the Network, ranging from

Aetna US Health Care to the American Heart Association to the Association of

State and Territorial Health Officers.

The American Chemistry Council supports the concept, noting ‘‘. . . data generated by a national tracking program can shift the focus from debate and speculation about disease trends to intervention and prevention based on scientific evidence.’’

Most local health departments face declining funding, inadequate training for

staff, limited or no laboratory access, and outdated information systems. The CDC,
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the Agency for Toxic Substances and Disease Registry (the ‘‘ATSDR’’) and other federal agencies have not been able to adequately help our local health departments.

For instance, most states do not have a chronic disease investigator. Recently in

Fallon Nevada neither the CDC nor the ATSDR could give Nevada written guidance, standards or protocols on how to investigate their childhood cancer cluster.

Our federal health agencies have never developed a concrete response program to

these growing disease cluster demands.

We are concerned that the Administration’s proposed budget recommends severe

cuts for the nation’s chronic disease prevention programs. Overall, the Administration is recommending $109,000,000 cut from last years budget for the CDC, most

of it coming from the National Center for Chronic Disease Prevention and Health

Promotion. We need to be going in the exact opposite direction. Health defense

should be the country’s number one commitment.

In order for us to identify clusters before they grow, we must take rapid action.

The CDC must be given the direct mandate to aggressively respond to communities’

concerns like those in Fallon and Wellington with modern tools and health tracking.

And Congress must prioritize $275 million per year—just a tenth of one percent of

the overall spending of health care dollars in this country.

Without this type of investment, we will only watch asthma, certain cancers and

other chronic disease rates continue to raise. There will be many more Fallons. And

that will be the greatest tragedy of all.

PREPARED STATEMENT OF THE UNITED FRESH FRUIT & VEGETABLE ASSOCIATION

United Fresh Fruit & Vegetable Association appreciates the opportunity to testify

in strong support of increased funding for nutrition, physical activity, and obesity

at the Centers for Disease Control and Prevention (CDC). As the national trade organization representing the views of producers, wholesalers, distributors, brokers

and processors of fresh fruits and vegetables, United has worked aggressively for

many years to enhance federal programs and policies to address the staggering costs

associated with poor diets and physical inactivity.

According to the U.S. Department of Health & Human Services (HHS), unhealthy

eating habits and physical inactivity are now the nation’s second leading actual

cause of death and are primary factors in the skyrocketing rates of obesity and

number of overweight persons. Unhealthy eating and physical inactivity are also

major causes of heart disease, cancer, stroke, diabetes, high blood pressure, and

osteoporosis. In fact, HHS estimates that unhealthy eating and inactivity contribute

to between 310,000 and 580,000 deaths each year, 13 times more than gun-related

deaths and 20 times higher than deaths due to illicit drug use.

The costs of diseases caused by unhealthy diets and physical inactivity are enormous. Annual costs related to cancer, coronary heart disease, obesity, diabetes,

stroke and osteoporosis now total nearly $550 billion. For Medicare patients alone,

the Health Care Financing Administration (HCFA) estimates that coronary heart

disease costs taxpayers $9.8 billion per year and strokes cost an additional $3.7 billion. Furthermore, when assessing the costs of diet related diseases only, the U.S.

Department of Agriculture (USDA) has estimated that healthier diets could prevent

at least $71 billion per year in medical costs, lost productivity, and lost lives. It is

important to note that this estimate only takes into account diet-related coronary

heart disease, stroke, cancer and diabetes and not other diet-related diseases.

It is obvious that the challenges faced by today’s healthcare delivery system have

changed enormously, and over the past century, the leading causes of death have

shifted from infectious to chronic diseases. These diseases are expensive to treat;

and many of them cannot be cured so they require years of expensive treatments.

The CDC has stated that of the 30-year increase in life expectancy between 1900

and 1999, only five years can be attributed to curative medicine, and the remaining

25 years of the increase represent advances in public health and preventive measures. However, today’s health care system is still geared almost exclusively toward

treatment of disease. Despite the proven success of preventive medicine, spending

by state and federal governments averaged $1,390 per person per year for disease

treatment and only $1.21 per person per year for preventive measures. We are not

advocating that these numbers should be reversed. We are, however, recommending

that the United States begin to make sound investments in preventive measures for

the well-being of all Americans. A modest investment in programs that can change

diet and activity patterns can prevent enormous long-term spending on treatment

in the future.

Leading health experts have asserted their firm belief in the benefits of a nutritious diet and physical activity. The National Academy of Sciences (NAS), CDC,
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USDA, Surgeon General, and others have affirmed that Americans must change

their diets and become more physically active if the rates of illness and premature

death are to be reduced.

With research documenting health benefits of increased fruit and vegetable consumption and increased exercise to reduce the risk of cancer and numerous other

serious illnesses including heart disease, stroke, obesity and high blood pressure, we

support aggressive action to further these important health messages. For example,

studies show that people who eat five or more servings of fruits and vegetables each

day have one-half the cancer risk of those who eat fewer than two servings. In the

area of physical activity, it is documented that a regimen of at least 30–45 minutes

of brisk walking, bicycling, or even working around the house or yard will further

reduce risks of chronic illness including coronary heart disease, hypertension, colon

cancer, and diabetes.

However, only one in four Americans consume five or more servings of fruits and

vegetables per day and children ages six to 12 are eating only two-and-a-half

servings of fruits and vegetables a day, half of the minimum amount recommended

by national guidelines. In the area of physical activity, research indicates that 60

percent—well over half of Americans are not regularly active. Worse yet, 25 percent

of Americans are not active at all. With such statistics and limited funding available

for federal campaigns to change these behaviors, poor diets, physical inactivity and

obesity will soon be the number one cause of preventable deaths and avoidable

health care costs.

Current trends document this assumption with at least one-third of all cancer, 20-

to-40 percent of heart attack and stroke, and as much as 80 percent of Type 2 diabetes being diet-related, and the diet- and exercise-attributable costs of these four conditions nationally are comparable to tobacco. Additionally, obesity which is a primary marker of poor eating and exercise habits, has been declared an epidemic by

CDC. This country desperately needs to attack the problem of poor diet and physical

inactivity with an initiative of similar scope and duration to that mounted against

tobacco over the last decade. The longer we wait to start, the harder it will be to

reverse, and the more we will pay as health care becomes more expensive.

To reverse these dangerous trends and begin to elevate this issue at the federal

level, United Fresh Fruit & Vegetable Association supports multi-year appropriations totaling $350 million for CDC to expand and build upon ongoing national and

state intervention initiatives within the Division of Nutrition and Physical Activity.

This funding level will allow CDC to implement a national coordinated nutrition

and physical activity plan in every state and a corresponding national media education strategy. Only through such aggressive funding increases will CDC in coordination with state departments of health be able to put in place a national strategy

that encourages healthy eating and increased physical activity that is supported by

coordinated communications efforts at the federal level. Presently, nutrition and

physical activity are the only major chronic disease risk factors without dedicated

funding for state intervention programs. While some states do have programs in

place for obesity prevention, nutrition and physical activity, these efforts will remain very limited and ineffective without substantial federal funding. The expertise

of the CDC in the implementation of effective intervention strategies, health communications, education, and prevention research will enhance the success of statebased efforts by providing states with additional federal resources to leverage their

efforts and ensure the implementation of best practices.

We are well aware of budget constraints facing the Committee. However, we

strongly encourage the Committee to carefully examine the need to take aggressive

action to implement a national coordinated nutrition and physical activity strategy

to address the staggering costs of chronic diseases. When you look at the costs associated with heart disease, cancer, diabetes, stroke, high blood pressure, and

osteoporosis which total $405 billion a year, we think that $350 million is a very

small investment to make in the future health of our nation.

We look forward to working with the Committee on this critical issue and hope

that this request can be accommodated to the maximum extent possible during the

coming fiscal year. Thank you for your time and consideration.

PREPARED STATEMENT OF THE UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW

JERSEY

The University of Medicine and Dentistry of New Jersey (UMDNJ) is the largest

public, freestanding health sciences university in the nation. Our statewide system

is located on five academic campuses and consists of eight schools (3 medical, a dental, nursing, public health, health related professions and a graduate school of bio-
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medical sciences). UMDNJ also comprises a University-owned acute care hospital,

three core teaching hospitals, an integrated behavioral health care delivery system,

a statewide system for managed care and affiliations with more than 200 health

care and educational institutions across the state. No other institution in the nation

possesses the resources that match our scope in higher education, research, health

care delivery, and community service initiatives with federal, state and local government entities.

The University’s priority projects are statewide in scope and include collaborations

both within the University system and with our academic and health care partners.

Our mission is focused on building ‘‘Centers of Excellence’’ that will expand our research, enhance our educational programs and provide access to quality health care

services for all New Jerseyans. Our projects also underscore UMDNJ’s commitment

to eliminating racial disparities in health care delivery, which is why our first priority initiative is the Institute for the Elimination of Health Disparities.

The Federal Government has identified striking disparities in the overall health

and life expectancy of racial and ethnic populations in the United States. Despite

dramatic improvements in health care, disparities still exist among racial and ethnic groups. In recognition of the importance of health disparities to the health of

all citizens, UMDNJ supports the efforts of the federal government in a number of

initiatives aimed at eliminating health disparities.

UMDNJ has long been recognized for its leadership in providing educational opportunities and health care services to under-represented communities throughout

our state. We are a leader in minority student education, minority faculty recruitment and patient care services to minority populations through our core and affiliated hospitals, clinics and community-based programs.

UMDNJ is developing an Institute for the Elimination of Health Disparities that

will have statewide impact. The mission of the Institute is to eliminate health disparities through training minority health care providers, improving research on minority health, increasing the number of minority scientists and improving outcomes

in health service delivery to minority populations.

The Institute is based in Newark, the largest city in New Jersey with a diverse

population, socio-economic status and special health care needs. Newark is also

home to UMDNJ-University Hospital, a Level I Trauma Center and the state’s only

public safety net hospital serving the largest number of indigent patients. In addition to Newark, the Institute will provide services in our host communities of Camden and New Brunswick, which also have large diverse populations.

Leadership of the Institute is provided by the UMDNJ-School of Public Health in

partnership with all schools of the University and with our Centers of Excellence

including the Cancer Institute of New Jersey; the Environmental and Occupational

Health Sciences Institute; the National Pediatric & Family HIV Resource Center;

the Hispanic Center of Excellence, the Minority Oral Health Research Center; the

Chandler Health Center (a Federally Qualified Health Center); and the Center for

Healthy Families and Cultural Diversity. The Institute will also collaborate with

state, county, city, community and private organizations to extend its visibility and

outreach.

The Federal Government has identified six broad areas that disproportionately affect racial and ethnic populations including infant mortality, cancer, cardiovascular

disease, diabetes, HIV/AIDS and childhood immunization. The Institute will focus

its research, training and education programs on initiatives related to these areas,

and will work to implement other programs that will improve overall health outcomes.

UMDNJ is ideally positioned to lead New Jersey’s efforts to eliminate racial and

ethnic health disparities. We are requesting $5 million over 5 years to carry out the

mission of the Institute for the Elimination of Health Disparities on behalf of the

citizens of New Jersey and the nation.

Our second priority is the Cancer Institute of New Jersey.

The Cancer Institute of New Jersey was established in 1990 with a $10 million

capital grant from the federal government. Over the past decade, CINJ has grown

to become one of the nation’s most successful cancer institutes and New Jersey’s

only NCI-designated clinical cancer center. New Jersey has been especially devastated by cancer where incidence and mortality rates are high compared to national averages. Since it opened its doors, CINJ is successfully fulfilling its mission

through innovative advances in research and patient care. CINJ’s basic and clinical

research are conducted in collaboration with its clinical partners and other academic

institutions, community physicians and health care professionals. CINJ’s provider

network of 20 hospitals stretches across the state and services reach people in every

county in New Jersey.
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CANCER INSTITUTE OF NEW JERSEY

One of CINJ’s significant accomplishments is the creation of the Dean and Betty

Gallo Prostate Cancer Center established with funding from the federal government.

The Center honors the late Congressman Dean Gallo, who succumbed to prostate

cancer in 1994. The Gallo Prostate Cancer Center has garnered $9 million in federal

appropriations over the past 3 years and is the state’s only specialized prostate

health resource located at an NCI-designated cancer center.

Because African-American males are 2.5 times more likely to die from prostate

cancer than white males, the Gallo Prostate Cancer Center has partnered with the

100 Black Men of New Jersey organization to offer prostate cancer screenings in minority communities throughout the state. A major goal of the Gallo Prostate Cancer

Center is to expand its educational awareness and health screenings to every county

in New Jersey.

Additional resources are needed to accelerate the Gallo Center’s promising research and to expand its services to the community through education and prevention programs. This expansion is hindered by a critical lack of space in CINJ’s New

Brunswick facility. Constructed in 1996 to accommodate 16,000 patient visits, CINJ

is now seeing 37,000 patients per year with more than 3,000 new patients seeking

care. Based on this rate of growth, CINJ anticipates between 50,000 to 60,000 patient visits per year and 5,000 new patients by the year 2003.

UMDNJ has responded to this need for additional space by approving the construction of a 120,000 square foot addition to CINJ’s New Brunswick facility. This

new space will house the Gallo Prostate Cancer Center as well as provide more

space for the treatment of other types of cancer, research, teaching and support

staff. We have commitments of $16 million toward the construction cost of approximately $30 million and request $10 million in federal participation to expand the

Cancer Institute of New Jersey facility to house the Gallo Prostate Cancer Center.

Another priority initiative is the Child Health Institute of New Jersey.

The UMDNJ-Robert Wood Johnson Medical School has developed the Child

Health Institute of New Jersey as a comprehensive biomedical research center focused on the health and wellness of children. The Child Health Institute (CHI) has

garnered close to $5 million in federal funds over the past two years and has been

awarded a $1.9 million facility grant from the National Center for Research Resources of the NIH in fiscal year 2000. The CHI has received $27 million from private foundations, corporations and individuals, as well as from the state and federal

government, to construct a 100,000 square foot research facility in New Brunswick,

NJ. The CHI will grow the current research funding base of the Robert Wood Johnson Medical School and strengthen research efforts with clinical departments at the

Robert Wood Johnson University Hospital, especially those involved with the new

Children’s Hospital.

The Child Health Institute will focus research on molecular genetics that direct

development of human growth and function. Research will serve as the basis for

new treatments, therapies and cures for devastating and debilitating childhood syndromes. Scientists will direct efforts toward the environmental, genetic and cellular

causes of diseases in infants and children in a quest to prevent, treat and cure these

diseases. Some of the disorders that warrant immediate attention include asthma,

muscular dystrophy, diabetes, birth defects and neuro-developmental disorders including autism and spina bifida.

Currently, the Child Health Institute serves as the hub for the New Jersey Governor’s Council on Autism at UMDNJ. The Council distributes grants from the State

to improve the treatment of autistic children, to educate families and physicians and

to investigate causes and possible cures for autism. The Child Health Institute represents the best hope for a sustained campaign against childhood diseases and disorders and provides a unique opportunity to support the health and welfare of this

generation and to protect the health of future generations.

Basic science is the key to the future of medicine. As scientists unravel the human

genetic code, the impact on America’s health is enormous. We are at the brink of

discovering which genes cause birth defects and the root causes for disease so that

prevention and cures can be realized.

The Child Health Institute has the expertise and the infrastructure in place to

achieve major breakthroughs and discoveries that will lead to improvements and

cures in childhood diseases.

We request $5 million in federal participation to cap the development of the Child

Health Institute of New Jersey.

UMDNJ is committed to scientific research that will benefit the elderly as well

as children. That is why our next priority is the Geriatric Research Center.
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The Center for Aging at the UMDNJ-School of Osteopathic Medicine (SOM) is an

inter-disciplinary center of excellence in geriatric education, clinical care and research. The Center is nationally recognized as a leader in quality care for older individuals through an array of services in the field of aging. Attracting more researchers to the Center is critical to achieving national prominence as a Geriatric Research Center of Excellence. The research programs of the Center will focus on the

cellular, biochemical and physiological basis of aging. Research will be directed at

the genetic determinants of both aging and diseases common in the elderly. The Research Center will build on existing programs in nutrition, protein loss, injury, Alzheimer’s disease to expand basic science research programs in support of the established clinical and educational programs at the Center for Aging. A major drawback

is the critical lack of dedicated research space to expand the Center’s research laboratories. We seek $5 million in capital and program funds to support dedicated

space for the Geriatric Research Center at the Center for Aging at SOM.

Our final priority is to implement a statewide medical response system to respond

to catastrophic emergencies as an integral component of the UMDNJ-Center for BioDefense in New Jersey.

UMDNJ has established a Center for BioDefense which achieved $3 million in

federal funding over the past two years. That funding is focused on scientific research to understand and identify infectious biological organisms in order to develop

treatments for victims of bioterrorist attacks.

New Jersey is the most densely populated state in the nation with more than 8

million residents. New Jersey is home to a myriad of high technology companies and

the national headquarters of leading-edge pharmaceutical, radiological and chemical

industries. As such, New Jersey is a prime target for terrorist attacks which employ

weapons of mass destruction including biological and chemical attacks. Successful

mitigation of these events requires a proactive, coordinated effort in planning, training, monitoring and response.

A significant component of the UMDNJ-Center for BioDefense is our expertise in

education and training concerning chemical and biological weapons. While emergency medical technicians and paramedics maintain state certification requirements, this does not include continued education in incident command, EMS mass

casualty response training, and hazardous material training.

The UMDNJ Center for BioDefense will use the expertise at UMDNJ-University

Hospital, the state’s Level I Trauma Center, and University Emergency Medical

Services (EMS) to provide statewide leadership in training of EMS, first responders

and other health professionals and to coordinate a standard regional response to incidents involving weapons of mass destruction, bioterrorism or public health threats.

The Incident Support and Operational Planning (ISOP) team will be responsible for

training, coordinated communications and response. The unit would also provide

technical expertise to assist communities in the development of emergency plans

and procedures.

The team will track and disseminate statewide hospital bed status through technology at University Hospital’s Regional Emergency Medical Communications System dispatch center. Improvements to the system would include implementing a secure internet-based tracking system, upgrading the existing radio system to integrate with the New Jersey State Police, the Office of Emergency Management, and

the Departments of Health and Transportation, as well as implementing an alert

network to provide public health agencies with information on potential public

health threats. We request funding of $2 million for the Center of BioDefense to assist our efforts to develop a statewide Medical Response System that will strengthen

New Jersey’s ability to respond to bioterrorism.

Thank you again for your past support and for the opportunity to present testimony of the University of Medicine and Dentistry of New Jersey (UMDNJ) on its

priority initiatives in cancer, children’s health, geriatrics, biodefense and the elimination of racial and ethnic health disparities.

PREPARED STATEMENT OF DR. WILLIAM H. LIPPY

I would like to express my support for increased funding of Universal Newborn

Hearing Screening (UNHS) programs through the Health Resources and Services

Administration (HRSA) and the Centers for Disease Control (CDC). President

Bush’s proposed budget for fiscal year 2002 cut appropriations for these programs,

despite the fact that deafness is the most common birth defect in the United States.

Each year 12,000 babies—one in 300—are born with some type of hearing impairment. Technologies such as hearing aids and cochlear implants can alleviate the

symptoms of deafness, although these interventions must be made within the first
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24 months of life in order to ensure full learning capabilities and language development.

Currently, only 32 states have enacted some type of newborn screening legislation

and less than half of all infants are screened for hearing impairment at birth. As

a result, deafness is not identified in children until age 30 months, on average, in

the United States. Special education costs an additional $420,000 per deaf child by

high school graduation, and the combined expenses of deaf education and lost productivity result in average lifetime costs of over $1 million per deaf individual. Newborn hearing screenings average $15–50 in price.

In fiscal year 2001, $8 million was appropriated to HRSA for UNHS, and approximately $6 million was appropriated to CDC. In order to sustain the grants of those

states that already receive funding and increase the number of participating states,

however, $10 million must be appropriated to both HRSA and CDC specifically for

UNHS in fiscal year 2002.

I appreciate your attention to this critical issue and request a response to my inquiry.

PREPARED STATEMENT OF THE UNIVERSITY OF MIAMI, CORAL GABLES, FLORIDA

Mr. Chairman and Members of the Subcommittee: I appreciate the opportunity

to appear before you today on behalf of my colleagues at the University of Miami

School of Medicine.

The University of Miami, a private university founded in 1925, has grown to become a major research and educational institution with strong collaborations and affiliations nationally and internationally. The University consists of 14 schools and

colleges with 2,341 faculty and 13,715 undergraduate and graduate students, with

facilities located on five campuses. According to the latest National Science Foundation survey, ‘‘Federally Funded Research and Development Expenditures,’’ the University ranks 40th nationally and 18th of all private universities with medical

schools. Annual expenditures in support of sponsored programs exceeded $194 million during the fiscal year ending May 31, 2000.

The School of Medicine was established in 1952, and was the first accredited medical school in the State of Florida. It has over 1,000 faculty members as well as a

large research, administrative, and support staff. In addition to 619 students enrolled for the M.D. degree, the School of Medicine offers a variety of graduate programs with over 350 enrolled students. With its community partner, Jackson Memorial Hospital, it comprises the second largest medical center in the United States

and is recognized for its excellence in research, teaching, and community service.

The University of Miami/Jackson Memorial Medical Center complex occupies 67

acres and combines facilities in three hospitals, an affiliated Veterans Administration Hospital, the Diabetes Research Institute, the Sylvester Comprehensive Cancer

Center, the Bascom Palmer Eye Institute, and numerous other facilities. Sponsored

program expenditures during the past fiscal year exceeded $142 million. NIH statistics for fiscal year 1999 rank the School of Medicine as 42nd among the 123 medical

schools receiving funding, with over $59 million committed to our programs. There

is an additional $5 million in annual NIH funding at our other campuses. U.S. physicians rank our teaching hospital in the top 10 percent of all teaching hospitals in

the nation.

One of the major objectives of the School of Medicine’s research programs is to

promote interdisciplinary collaboration and translational research. Basic scientists

and clinicians interact regularly through structured programs and disease-oriented

conferences. These have resulted in innovative research and, more importantly, the

translation of our basic laboratory findings to the clinical setting. The University

has invested its own funds in numerous projects and facilities dedicated to advancing this objective.

In this regard, the University of Miami respectfully requests the Subcommittee

to allocate funding that assists in understanding the incidence and causes of disease

among particularly vulnerable populations—children, women, the elderly and ethnic

minorities, and especially among African-American, Hispanic, and Native American

populations.

HIV/AIDS

Miami and the surrounding South Florida region continue to show strong population growth with an unparalleled ethnic diversity. The incidence of HIV and

HTLV infections among this population group is high and requires continuous

health support. In turn, this patient population offers a unique opportunity and
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challenge for the understanding of disease pathogenesis caused by HIV/HTLV, including the progression to neoplasia and immunodeficiency.

Investigators at the University of Miami School of Medicine have played important roles in helping to understand and resolve the HIV/AIDS crisis locally, nationally and internationally. In addition to studies in the United States, we have collaborative HIV programs in the Dominican Republic, Zambia, China, and India. Examples of significant seminal research studies conducted at the University of Miami

produced the following findings: AZT protection of newborns from maternal/fetal

transmission of HIV; transmission of HIV through sharing of needles by drug abusers, discovered here, led to initiatives in interrupting this route of transmission; and

the effectiveness of the combination of Ifn-a with AZT for the treatment of AIDS

related lymphomas was elucidated here recently.

The strong clinical, epidemiological and behavioral research programs at the University continue to attract a high level of competitive funding from the NIH, as evidence of their vitality and strength. However, it has become clear in the research

community that further progress in limiting HIV/HTLV morbidity and mortality requires a broader understanding of HIV/HTLV pathogenesis. It is evident that the

changes during disease onset and progression, both in the virus and in the immune

system of the host, are complex and far from understood. It also is clear that a deeper insight into the virus-host relationship is the only way by which further progress

can be made. Some institutions have significant NIH funding for HIV/AIDS research

in clinical trials and epidemiological studies; however, with modest funded laboratory research programs.

We ask that the Committee provide resources to support programs through the

Health Resources and Services Administration that allow for the enhancement of facilities and equipment that bolster HIV/AIDS basic research and treatment facilities

and equipment especially for children, and particularly in entities with recognized

excellent epidemiological and clinical programs.

MINORITY RESPIRATORY DISEASE RESEARCH

Vulnerable populations in the United States, especially those located in major

metropolitan areas, are experiencing a much higher and more severe level of respiratory disease. Diseases such as asthma, and smoking related diseases such as

lung cancer and emphysema, are rising at unprecedented rates. To address these

critical issues, unique partnerships that bring together existing national research

assets that can focus on developing new treatments and preventative strategies designed to have the maximum impact on vulnerable groups, which include children,

women, the elderly and African-American, Hispanic, and Native American populations.

Respiratory diseases including asthma, chronic bronchitis, emphysema, and lung

cancer are a growing problem in the United States and worldwide. While mortality

from most chronic diseases such as heart disease and cancer has substantially declined over the last few decades, deaths from respiratory diseases have increased

and are projected to continue to increase over the next decade. Although many respiratory diseases are attributable to smoking, asthma, which most commonly afflicts

young non-smokers, has also had a remarkable increase in incidence and mortality.

Respiratory diseases occur most commonly among children and the elderly, and also

tend to have the most impact on these vulnerable populations. Population-based

surveys have suggested that most of the increase in respiratory disease has occurred

among minority populations and children. Also, at equivalent levels of environmental exposure, women are more susceptible to developing respiratory disease

than men.

It is not clear why there has been an increase in respiratory disease. Most respiratory diseases are the consequence of complex interactions between environmental exposures and individual susceptibility factors. The pathway from environmental exposure to the diagnosis of respiratory disease may be affected by multiple

factors at every step that confound or modify the exposure-disease relationship. The

complexity of this system makes it difficult to identify causal relationships or to interpret the significance of these relationships when they are found.

For example, several studies have suggested that exposures that result from

crowded inner-city conditions could be responsible for the increased incidence of

asthma in African-American children; however, others have suggested that a lack

of exposure to common environmental pathogens could result in the immune system

hyper-reactivity that characterizes asthma. However, without a complete understanding and inventory of environmental exposures, it is impossible to know what

contribution inheritance has had to the increased incidence of disease, or how potential new therapies targeted at immune-system defects will help.
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Without a multidisciplinary approach, it is unlikely that researchers ever will be

able to identify the true causes of this increase in respiratory illness, much less design effective solutions. To conquer this problem, it is essential that the resources

and talents of scientists from a broad spectrum of disciplines work cooperatively,

and that the mechanisms of respiratory disease in a variety of regions and ethnic

groups be carefully examined.

We urge the Committee to support initiatives through the CDC and Public Health

Emergency Fund that will advance long-term organized community-based health

utilization studies, especially those that examine the growing incidence of respiratory disease among minority populations. State-of-the-art collaborations with

recognized partners that have traditional affiliations with minority populations and

that will allow the use of innovative research techniques will help elucidate the significance of specific causative factors across different populations in the affected

communities, and beyond.

THE ELDERLY AND ELDER ABUSE

Demographic reports unequivocally document the fact that the fastest growing

segment of the U.S. population is those over the age of 65 years, especially the ‘‘elderly’’ elderly, over the age of 80 years. Florida is in the unique position of having

the fastest growing elderly population, and South Florida, in particular, of having

to deal with the cultural diversity of that population. With the increasing probability of longer life spans, come increasing problems related to chronic diseases and

fewer social and economic resources. Elderly individuals are particularly vulnerable

and require more medical, legal, and social interventions as well as greater dependence on family caregiving where possible. In response to the needs of older Americans the necessity to develop extensive and integrated services is critical. These

services range from assessments of competency and functional capacity and guardianship, to the end of life decision making, to long term care issues, elder abuse,

to resource allocation and the economic impact on the aging population and their

families.

Though not all encompassing, the importance of education and research in this

arena will have significant impact on shaping public policies and on practical approaches to assist the medical and legal fields, including law enforcement, the judiciary, and policy makers.

We urge the Committee to provide funding through the Administration on Aging

and the Health Care Financing Administration for programs and projects that address the specific issues of importance to the aging population, including: abuse and

neglect, management models for unique care requirements, a focus on the role of

families and caregivers, end-of-life care, mental capacity, and research ethics. We

would envision programs and projects that would involve collaborations between

university schools of medicine and law and clinicians and researchers in related university departments and in community agencies.

Mr. Chairman, we understand how difficult a year this will be for you and the

Subcommittee. However, my colleagues and I at the University of Miami respectfully request that you give serious consideration to providing support for initiatives

that assist in understanding the incidence and causes of disease among particularly

vulnerable populations—children, women, the elderly, and ethnic minorities, and especially among African-American, Hispanic, and Native American populations. Vital

initiatives in these areas all have great implications and will provide exceptional

benefits to the well being of the nation.

Thank you for allowing me to appear here today.

RELATED AGENCIES/GENERAL TESTIMONY

PREPARED STATEMENT OF THE AMERICAN LIBRARY ASSOCIATION

The American Library Association appreciates the opportunity to present testimony for the record in support of appropriations for library programs through the

Library Services and Technology Act, administered by the Institute of Museum and

Library Services.

We thank the Subcommittee and you as Chairman for your strong support for libraries in the past and ask for that support again for appropriations for fiscal year

2002.

All Americans benefit from the small, but critical, Federal role that assists libraries to foster an informed citizenry in the service of democracy. Federal support for

libraries is concentrated on two key national goals: outreach to those for whom library service requires extra effort or special materials, (such as individuals with dis-
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abilities); and, mechanisms to identify, preserve and share library and information

resources across institutional or governmental boundaries through technology. The

Federal role has traditionally focused on areas which require incentive funding for

activities that libraries have difficulty initiating independently, which involve coordinated interstate and intrastate efforts, or which benefit from a national policy

initiative.

The library community is capable of astonishing creativity and expertise in support of national goals such as revitalizing the economy, having children start school

ready to learn, and developing literate, informed adults. Oftentimes, one of the few

sources of funding for innovation available to libraries is Federal funding. It is estimated that library programs generate some $3 to $4 dollars for every Federal dollar

invested.

President Bush has said on many occasions in discussing his new education proposals that ‘‘we must leave no child behind.’’ America’s libraries believe that we can

also afford to leave no reader behind. That statement also includes pre-readers such

as very young children, those learning to read, young adult and adult learners. That

is why we feel so strongly that library programs need additional Federal funding.

Within the overarching theme of ‘‘Leaving No Reader Behind,’’ our specific recommendations for fiscal year 2002 are guided by three basic priorities, I am sure

you share our vision that:

—We need to ensure equitable access and participation of our nation’s readers to

library activities and opportunities in their communities. Gaps in access exist

not only in rural areas, but also in cities that lack an advanced telecommunications infrastructure.

—We need to support our libraries’ continuing efforts to keep pace with the rapidly changing information technology environment. Indeed some of our libraries

are at the forefront of the web-based revolution, but many others need to accelerate their initiatives.

—We need to recognize the important contributions that libraries make to the social, civic, and educational health of their communities. Like many schools, libraries often serve as the hubs of their communities and provide important

services, training in technology and opportunities for life-long learning, particularly in traditionally under-served areas.

THE LIBRARY SERVICES AND TECHNOLOGY ACT (LSTA)

I am please to convey ALA’s deep appreciation to the Subcommittee for the support it has provided in the past for libraries and Federal library programs, particularly your support of the Library Services and Technology Act (LSTA) state grant

program; library services to Native Americans; and the national leadership grants

program.

FISCAL YEAR 2002 FUNDING REQUEST: $350 MILLION FOR LIBRARIES

The library community has collaborated on developing a draft for the reauthorization of the Library Services and Technology Act and will be working with the House

and Senate authorizing committees this year on the reauthorization. The current

authorization expires at the end of fiscal year 2002. We are seeking to increase the

authorization level to $500 million. As you know, this represents a significant expansion in the Federal government’s commitment to the support of our nation’s libraries. Today we request your support for fiscal year 2002 for a down-payment of

$350 million for library programs authorized under the Library Services and Technology Act.

Libraries are making great strides in preparing for and introducing technology to

their users. With this increase more libraries could expand their services to include

technology training and access to the world wide web for their users.

It would also enable libraries to provide additional badly needed services to underserved populations in their communities. These outreach efforts can pay off in

terms of literacy programs that enable students to achieve success in education and

programs for families who may not have used libraries before. Library programs for

young children encourage pre-reading skill development and stimulate a love of

reading, but only if funds are available for these programs.

It is important to note that funding for the State grant program for libraries has

not increased significantly in recent years. In fiscal year 1997 it was $136,369,000;

in fiscal year 2001 it is $148,939,000. Library services are not keeping pace with

the increases in populations in most States.

In fiscal year 2001, the total distributed to states was $148,939,000 and of that,

Pennsylvania received $5,964,319. The state library has already received requests

for over $6,892,604, and expects at least requests for $3 million more in the second
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round of grant requests in the fall. An increase in state distribution to $350,000,000

would bring Pennsylvania dollars up to roughly $11 million. This doubling of funds

could enable more outreach to Pennsylvania’s rural areas, more attention to technology, and more resource sharing for all libraries, school, academic and public in

Pennsylvania. State libraries always report that the requests for funds are double

and sometimes triple the amount actually awarded.

$400 MILLION FOR TITLE VI—INNOVATIVE EDUCATION PROGRAM STRATEGIES

We also ask that you fund the Elementary and Secondary Education Act Title VI

block grant at least at the $400 million level. We appreciate your support of Title

VI, particularly since it is the only current funding possibility for school libraries.

As you know, school library materials are only one option of many in the block grant

and less and less of the funds are being used for school library materials.

As a result, many school libraries have old, outdated and inaccurate material on

their shelves. In research done in Alaska, Pennsylvania and Colorado, it was found

that a good school library media program is an excellent predictor of improved student achievement. That is why we feel it is so important to provide adequate funding for school libraries.

21ST CENTURY COMMUNITY LEARNING CENTERS

We support funding for the 21st Century Community Learning Centers program.

School library media centers have the potential to be after-school learning centers.

If properly equipped and adequately staffed by professional library media specialists, school library media centers are a perfect place for after school learning. Currently, public libraries as part of a consortium also can function as after school

learning centers. Many places, particularly in large urban areas like Chicago, Baltimore, New York and Miami, perform that service, however, the bulk of the grants

are used by schools. We support initiatives to allow public libraries and other community organizations to be the lead agency.

IMPACT OF LIBRARIES

No public institution maximizes a modest amount of federal funds to greater public benefit than libraries. Libraries are efficient users of federal dollars. Funds are

leveraged to attract other dollars; to demonstrate new and innovative methods of

providing service; and to bring new users into the library for learning, literacy and

the information needed for more productive daily living.

IMPORTANCE OF TECHNOLOGY

Both school and public libraries have made great strides towards the goal of full

Internet access. However, effective public access is far from complete. We believe

that the E-rate telecommunications discounts are critical to our nation’s libraries.

The library community believes that this program must be continued in its current

form. The first three years of this E-rate fund have created the stimulus for more

schools and libraries to connect to the Internet, particularly in areas where the discounts have been the greatest. The progress has been immense and needs to continue. Over 95 percent of public libraries offer Internet access to their patrons.

Moving the program from its fund status to one supported by the appropriations

process would be difficult and likely result in a strain on other important education

programs and a reduction of the amount available. Telecommunications providers

like BellSouth are so enthusiastic about the program that they are providing training to help schools and libraries apply. Please do not disrupt this program—it

works.

Federal funding supports the continuing investment libraries must make in computer hardware and software, electronic content and training for staff and the public. An increase in LSTA program funding to the $350 million level would allow

more of the 16,047 library outlets to connect to the Internet and begin to provide

training and information access services to families, adult learners, the small business sector and all in the community who need access. Sixty-five percent of all

households use public library services each year, according to data from the National Center for Education Statistics.
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PREPARED STATEMENT OF THE NATIONAL ASSOCIATION OF STATE WORKFORCE

AGENCIES

BUILDING A STRONG WORKFORCE

The members of the National Association of State Workforce Agencies are the

state leaders responsible for building and overseeing workforce development activities through the administration of a one-stop center infrastructure and the implementation of workforce-related programs. These programs include labor exchange

activities, Internet job matching, unemployment insurance administration, labor

market information services, veterans’ employment services, job training and welfare-to-work programs. Several critical components of this publicly administered

workforce development system—unemployment insurance, employment services and

labor market information programs—are financed through taxes on employers.

Thus, a strong connection to the needs of the private sector business community is

critical to the continued viability of the workforce development system.

The primary emphasis of current workforce development efforts in the states is

the connection of employers with job seekers. In each of the states, the workforce

development system plays a vital role in the success of the local economy by providing services that build a stronger workforce, enhance employee skills, and promote economic development by helping attract and retain large and small businesses. In addition, with implementation of the Workforce Investment Act of 1998 (WIA),

the new workforce development infrastructure being developed in each of the states

strives to address the changing needs of the new economy by empowering individuals to make appropriate job choices including enhancing their skills through training opportunities. At the core of this new paradigm is understanding the needs of

business in the new economy and preparing workers who can immediately contribute to the health of a company and allow economic growth to continue.

As state workforce officials strive to marshal the resources within a state and

build this much needed system capacity, their role has become even more important

as they serve as:

—Leaders and change agents in creating a workforce vision and implementing

new services and opportunities for businesses and workers;

—Partners with various federal, state and local officials who each share responsibility for the new workforce development system;

—Overseers of a customer-driven system that focuses on the needs of employers

and job seekers;

—Supporters of the one-stop center system who work closely with local planners

in developing service delivery systems that match customer wants and needs;

and

—Facilitators of systems integration so that services can be provided seamlessly.

While providing leadership and building strong workforce investment systems,

state administrators are facing two unique challenges which come as a result of economic forces and highlight the need for adequate workforce system funding. The

first is company ‘‘churning,’’ where American workers with low skills are displaced

while job growth is occurring in high skills industries, and the second is the pending

economic slowdown that might turn into a recession.

With these two factors as a backdrop, I want to outline the important need to increase funding for (1) unemployment insurance administration to ensure the economic safety net for workers is strong enough to withstand an economic slowdown,

(2) the employment service as the cornerstone of one-stop center systems and the

connection between employers and job seekers, (3) WIA training and labor market

information to assist customers with market-based solutions to their employment

needs, (4) incumbent worker training to assist with business and employer needs

in the changing economy, and (5) veterans’ employment and training. These funding

improvements, along with the system improvements that are occurring, can support

employers and workers who are hardest hit by emerging economic changes.

FIRMS ‘‘CHURN’’

The aggregate economy has seen the largest boom in history, with economic expansion running into its ninth year in 2000. The unemployment rate fell for seven

straight years, from 7.5 percent in 1992 to 4.1 percent in 1999. An unemployment

rate of 4.1 percent was the lowest level in 30 years. After accounting for inflation,

median weekly earnings of full-time wage and salary workers increased last year,

marking a third consecutive year of gains in real earnings.

Yet, workforce system builders have seen unique challenges during the good economic times as firms ‘‘churn’’ employees. In a recent survey, the American Manage-
688

ment Association found that 36 percent of the approximately 2,000 companies contacted created new jobs at the same time that they cut existing jobs.

The demand for skilled labor has forced employers to adapt quickly. Companies

that once engaged in employee retraining or waited for employees to leave voluntarily find that the quickest alternative is to replace these workers with new employees who have skill sets currently in demand. This leaves the workforce development system with the large challenge of retooling a whole set of workers with outdated skills, while serving employers with large gaps in their workforce due to a

lack of qualified workers.

To solve this problem, the workforce development system is actively engaged in

assisting employers with the skills training that workers need to keep updated on

new technologies and new workplace production methods. Workers must adapt to

new technologies in order to remain competitive in the labor market. An important

partner in this effort is the education community, and in many areas of the country,

the workforce development system and the community college system have developed programs that assist workers with on-the-job training and skills retraining.

Technology is playing an ever-increasing role in productivity gains made by businesses and the way workers conduct their jobs. Technology is also becoming a critical tool for job seekers and employers looking to hire. The Internet allows job seekers to sift through a whole host of jobs at their convenience, while employers can

post jobs and also search through resumes. State workforce agency administrators

are proponents of using technology to assist employers and job seekers in making

more informed decisions and have implemented job matching and other workforce

technology into service delivery systems.

AN ECONOMIC SLOWDOWN?

Recent news headlines point to a coming economic slowdown. While it is not

known to what extent the economy will contract, what is known is that the growth

rate of recent years is not sustainable. This means that unemployment will grow

and workers will lose jobs, even in the high tech sector. Efforts at preparing for a

slowdown, and even a potential recession, have been undertaken during the past

year. For example, the states are providing leadership in efforts to strengthen and

improve administration of unemployment insurance and the employment service

system.

UNEMPLOYMENT INSURANCE AND EMPLOYMENT SERVICES

Last year, representatives from the states, United States Department of Labor,

business and labor met to craft a package of reforms that included, among other

things, repeal of the Federal Unemployment Tax Act (FUTA) 0.2 percent surtax and

unemployment insurance and employment services administrative funding improvements.

A hearing was held last September before the House Ways and Means Subcommittee on Human Resources. Because of the short legislative timeframe and the

intense budget negotiations that lasted into fiscal year 2001, no further action on

unemployment insurance and employment services reform was taken in the 106th

Congress.

Because a number of governors have expressed support for this reform, as well

as a number of state business organizations, it is our intent to work on a bill this

year. Meanwhile, until the long-term structural changes are enacted, states are

struggling in the short-term to maintain an essential infrastructure for the unemployment insurance and employment service system that meet the needs of businesses and workers.

These issues get to the core of the success of the nationwide one-stop center system. If unemployment insurance and employment services continue to be neglected,

then the essential ‘‘job connection’’ that has successfully moved unemployed and dislocated workers into meaningful employment and assisted single mothers on welfare

with job skills and job attachment will be lost. States are now closing offices in local

communities and reducing staff—substantially decreasing needed services to employers and job seekers. We urge the Congress to fund fiscal year 2002 unemployment insurance at $2.65 billion, which reflects need based on workload.

We also urge the Congress to fund the Employment Service State Allotments at

$933 million and Reemployment Services at $35 million. Our request for Employment Service State Allotments represents the current appropriation of $761.7 million plus the amount that state legislatures have funded—$135,033,684—through

state appropriations, plus a four-percent growth allowance. It is a travesty that

state legislatures must essentially double tax employers to provide needed employ-
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ment services while FUTA taxes are building excessive balances in the unemployment trust fund.

It is also disheartening that Congress does not provide adequate funds for a program that yields measurable cost savings. A recent study of the public labor exchange in Washington and Oregon indicates that direct placement services conducted through the public employment service return as much as two dollars for

every one dollar spent. This is a result of reduced unemployment insurance payments as unemployed job seekers gain quicker reentry into the labor market. In addition, the employment service assists employers by filling job vacancies more quickly, enhancing companies’ productivity.

This study of Washington and Oregon validates a broader study conducted in

1999 that found similar results:

—Job search assistance participants found a new job more quickly and the duration of unemployment insurance benefit payments was reduced.

—Savings to the government averaged two dollars for every one dollar spent.

—Shorter job searches did not lead to jobs that paid less.

We urge you to address funding shortfalls for the unemployment insurance and

employment service system.

WORKFORCE INVESTMENT ACT

In 1998, Congress passed the Workforce Investment Act, the first major reform

of the nation’s job training system in over 15 years. It was designed to replace the

patchwork federal system that developed over the last sixty years with a locally designed and driven system to improve the quality of the workforce, enhance the productivity and competitiveness of the nation and reduce welfare dependency. The

Workforce Investment Act took effect on July 1, 2000. It passed by a wide bipartisan

majority, in part because it was designed to permit communities and states to build

a workforce investment system that respects individual choices, reflects local conditions, and results in increased employment, retention, and earnings of participants,

and increases occupational skills attained by participants.

The Workforce Investment Act redesigned the nation’s workforce development system to:

—Streamline multiple employment and training programs into an integrated onestop center system, simplifying access to services for job seekers and employers.

—Empower individuals to get the services and skills they need to improve their

employment opportunities through qualified training programs of their choosing.

—Increase accountability of states, localities and training providers for their performance based on job placement rates, earnings, retention in employment, skill

gains, and credentials earned.

—Involve local elected officials and the private sector in business-led boards for

the local areas focusing on strategic planning, policy development and local

oversight.

—Allow state and local flexibility to implement innovative and comprehensive

workforce investment systems to meet the needs of their communities.

—Improve youth programs by creating Youth Councils that are linked more closely to local labor market needs and the community.

Partnerships at all levels—local, state and federal—and across the system are the

hallmark of the new workforce investment system. All levels are required to coordinate and collaborate with agencies and entities that have not been a part of the traditional workforce development system. Accountability and responsibility for outcomes at all levels of the system now exist, with each level having unique and integral roles and responsibilities.

The goal of the Workforce Investment Act is to provide employment and training

services in a one-stop environment. Under the former job training program, the Job

Training Partnership Act, training was limited to eligible populations. Under the

new law, no eligibility criteria exist, and services are universal. We recognize that,

in the first year of implementation, spending on training services is low. However,

the only way to address the growing skills gap between employers’ needs and workers’ skills is through training. We support a fiscal year 2002 appropriation of $988

million for Adult Training, $1.147 billion for Youth Training, and $1.1653 billion for

Dislocated Worker Assistance that is essentially a current services budget for WIA

programs with a four-percent increase over fiscal year 2001 levels.

KEEPING WORKERS ATTACHED TO JOBS

In addition to providing basic employment and training services, we strongly believe that the workforce system must assist incumbent workers as they upgrade
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their skills and keep their individual portfolios viable, while at the same time meeting their company’s evolving labor needs. We support $30 million in Workforce Investment Act funds for incumbent worker training. Our competitive advantage in

the world economy rests in large measure on upgrading our workers’ skills.

LABOR MARKET INFORMATION

Providing labor market statistics for use by job seekers and employers at the local

level, rather than just on the national and state level, is a new service expectation.

In order to provide more localized information as well as program performance information, considerable enhancements to statistical programs and information systems are needed. These enhancements will pay off as local labor market needs will

be more accurately assessed and employment programs can be tailored to meet the

needs of local employers. Therefore we support a four-percent increase for the Bureau of Labor Statistics for a total appropriation of $213 million, and a continued

investment in One-Stop/ALMIS dollars of $150 million. We also ask that report language contained in last year’s appropriation for One-Stop/ALMIS be included as bill

language in this year’s appropriation bill.

The bill language we request reads, ‘‘One-Stop/ALMIS funds will be used to support infrastructure upgrades at the state level for one-stop center system operations,

labor market information, and integrated services to employers and job seeker customers.’’ This will ensure that the dollars go to the states, where infrastructure

needs are most critical.

MEETING COMMITMENTS TO VETERANS

Our society recognizes the important contribution that veterans have made, and

Congress has taken that recognition and turned it into a commitment. Title 38 of

the U.S. Code includes provisions for special employment services for veterans. Priority is given to disabled and Vietnam era veterans, through the Disabled Veterans

Outreach Program (DVOP) and the Local Veterans Employment Representative

(LVER) program, which are administered by state workforce agencies. DVOPs and

LVERs also serve our veterans population by helping to ensure a smooth transition

for people moving from military service into the civilian workforce.

Title 38 provides formulas to determine DVOP and LVER staffing levels. Since

1990, appropriations for DVOPs and LVERs have not supported the number of positions authorized by the statutory formulas. We strongly encourage support for funding at the statutorily-authorized levels of $121 million for the DVOP program and

$102 million for the LVER program. This will help us follow-through on our commitment to the men and women who have served valiantly in the military both in times

of war and peace.

CONCLUSION

I do believe we are making significant strides in building the workforce investment system in each of the states. With a potential slowing of the economy, we cannot afford to wait any longer for the improvements that need to be made so that

families can be served with their workforce development needs. With additional investments by Congress, I know that we are prepared to help those citizens needing

job placement or skills training assistance and those businesses looking for good,

solid workers who can improve their economic prospects. Thank you for your interest and support.

PREPARED STATEMENT OF THE NATIONAL TREASURY EMPLOYEES UNION

Chairman Specter, Members of the Subcommittee: My name is Colleen M. Kelley

and I am the National President of the National Treasury Employees Union

(NTEU). On behalf of the 150,000 federal employees NTEU represents, thank you

for permitting NTEU to share our views concerning the fiscal year 2002 budget.

NTEU represents employees in a number of HHS agencies including the Health

Resources and Services Administration, Indian Health Service, Substance Abuse

and Mental Health Services Administration, Agency for Healthcare Research and

Quality, Administration for Children and Families, Administration on Aging, Office

of the Secretary, Office for Civil Rights, Program Support Center and the National

Center for Health Statistics. NTEU also represents employees in the Social Security

Administration’s Office of Hearings and Appeals.

As the Chairman knows, funding remains severely constrained at federal agencies, leaving agencies with insufficient resources to complete their missions or adequately reward their employees. Funding shortfalls have resulted in hiring restric-
691

tions and delayed and canceled employee training, making it difficult for employees

to do the best job possible. Moreover, with federal salaries continuing to lag well

behind similar private sector salaries, agencies have been unable to hire or keep the

expertise they need.

In fact, the looming crisis in the federal government recently caused the General

Accounting Office to place human capital management on its High Risk List. The

GAO stressed that federal employees are assets to be valued, not costs to be cut.

Adequate and stable agency funding coupled with appropriate pay, benefits and incentives are the keys to insuring that the federal government continues to attract

and retain the right federal employees.

With surpluses predicted for the immediate future, the opportunity exists to provide adequate resources to federal agencies. Doing so will enable federal employees

to carry out their agencies’ missions to the best of their abilities and provide first

class service to agency customers. Unfortunately, the President’s budget calls for an

average 4 percent increase in discretionary agency funding, an amount clearly inadequate to address the crisis the federal government faces and move human capital

management off the high risk list. If there is room in the federal budget for a tax

cut in excess of $1 trillion, clearly there is room to adequately fund federal agencies.

The Administration’s fiscal year 2002 budget request for program management at the Health Resources and Services Administration (HRSA) is $154 million. Although

this figure represents a $9 million increase over program management funding for

fiscal year 2001, the budget also calls for a reduction of 24 FTE in the next fiscal

year. I think this shows quite clearly how inadequate the proposed $9 million increase is. HRSA’s goal is to bring health care services to some of our neediest populations, including those in underserved rural communities, people living with HIV/

AIDS, and those who are uninsured. HRSA provides essential services that are desperately in need of expansion; they cannot accomplish their mission with fewer employees and inadequate resources.

The employees represented by NTEU at the Agency for Healthcare Research and

Quality (AHRQ) strive to improve the quality of patient care in our health care system. This agency’s goal is to both cut the number of medical errors and explore

ways to better use research to improve medical care in our country. The Administration’s fiscal year 2002 budget proposal calls for $3 million for program support at

the AHRQ, the same amount the agency received in fiscal year 2001. AHRQ will

not be able to continue its mission and maintain its current staff without additional

funding.

Likewise, the Administration’s budget proposes no increase in funding for program management at the Substance Abuse and Mental Health Services Administration (SAMHSA). This agency is at the forefront of efforts to provide early intervention programs designed to discourage young people from using drugs. SAMHSA also

plays a critical role in insuring that mental health and drug abuse services are

widely available to populations that would otherwise receive no services. If

SAMHSA is to adequately respond to the substance abuse and mental health needs

in this country, they will require an increase in funding. In fiscal year 2001 the

agency received $67 million and 632 FTE. The President’s budget freezes the agency

at an identical, and insufficient, level for fiscal year 2002.

Under the President’s budget, the Indian Health Service (IHS) is slated to receive

$2.9 billion for its health services programs in fiscal year 2002. This budget request

reflects a small increase of $151 million over the fiscal year 2001 level of $2.8 billion

which NTEU believes fails to recognize and value the important work this agency

does in improving health care for the millions of American Indians and Alaska Natives. A substantial increase is warranted here as well.

The fiscal year 2002 budget request for federal administration at the Administration for Children and Families (ACF) is $182 million, an $8 million increase over

fiscal year 2001 funding. As the Chairman knows, ACF is one of the government’s

premiere agencies for promoting the health and welfare of America’s children. Programs under its jurisdiction include Head Start as well as projects that promote and

support child care, foster care and adoption efforts. The 2002 budget request would

severely hamper ACF’s ability to continue to provide quality services. It envisions

permitting the agency to hire no more than 15 additional staff in the next fiscal

year, a number that does not reflect the importance these employees play in overseeing the critical Head Start Program. Funding restrictions in past years have already hampered ACF’s ability to fulfill its mission and I urge the Subcommittee to

provide additional fiscal year 2002 funding over and above the President’s request.

For fiscal year 2002, $18 million is requested for program administration at the

Administration on Aging (AoA), a $1 million increase over the agency’s fiscal year

2001 funding level. America’s elderly population continues to grow and helping older

Americans remain independent and productive is one of the key goals of AoA. The
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employees of AoA operate nutrition programs and are active in the Alzheimer’s programs. To continue and expand its work, the AoA, too, requires funding increases

that reflect its critical mission.

NTEU also represents employees in the Office of the Secretary of HHS. The President’s budget request for departmental management is $450 million for fiscal year

2002, an increase of $68 million over fiscal year 2001 funding levels that will allow

the agency to hire an additional 107 FTE. As you know, the employees in the Office

of the Secretary help support those activities associated with the overall operation

of the department and NTEU hopes the Subcommittee will support this proposed

increase.

The President’s budget request for the Office for Civil Rights (OCR) for Fiscal

2002 is $32 million, an increase of $4 million over the fiscal year 2001 funding level.

HHS’s Office for Civil Rights enforces the Nation’s civil rights statutes that prohibit

discrimination in social service programs. Moreover, OCR plays a central role in efforts to prohibit discrimination against individuals with disabilities in programs

under HHS’s purview. In past years, the funding levels OCR has received have not

reflected OCR’s critical mission and NTEU urges the Subcommittee to provide the

maximum possible increase to OCR in fiscal year 2002.

For the National Center for Health Statistics (NCHS), the Administration has requested $127 million for fiscal year 2002, an increase of $5 million over the fiscal

year 2001 level. One of NCHS’s primary responsibilities is to follow changes in

health and health care, assess the effectiveness of health care programs and identify

health and disease patterns and risk factors in our country. The NCHS deserves the

maximum possible allocation for fiscal year 2002.

As the name implies, the Department’s Program Support Center (PSC) provides

support services to HHS and other agencies. These services include efforts in three

areas, including human resources, financial management and administrative operations. For fiscal year 2002, the Administration has recommended a funding level

of $308 million for PSC, a small increase over the division’s fiscal year 2001 budget

that NTEU hopes can be increased during Subcommittee deliberations.

NTEU also represents employees in the Office of Hearings and Appeals (OHA),

and as I have brought to this Committee’s attention in past years, OHA is again

the subject of reorganization. The latest, the Hearing Process Improvement (HPI)

plan, is not working.

As you know, disability claimants who have been found ineligible for disability

benefits are entitled to a timely and fair hearing of their cases at the OHA level.

In 1995, the Social Security Administration began an innovative program called the

Senior Attorney Program, which, in every respect, was a resounding success. The

agency’s experienced staff attorneys were given the authority to decide and issue

fully favorable decisions—without the time and expense of a full hearing—in those

cases where the evidence clearly identified an individual as disabled. It materially

improved both the quality and timeliness of service provided to the public. Despite

the success of the Senior Attorney Program, the Hearing Process Improvement Plan

eliminates it, largely due to opposition from Administrative Law Judges.

From 1995 until it was canceled in 2000, nearly 230,000 Senior Attorney decisions

were issued. It is noteworthy that the SSA Appeals Council found no significant difference in the accuracy of Senior Attorney decisions vs. full, on the record decisions

made by the agency’s Administrative Law Judges. Moreover, these Senior Attorney

decisions helped reduce the backlog of cases at OHA to 311,000 by September of

1999. That backlog is now on the rise.

The average processing time for a case favorably decided by a Senior Attorney

was approximately 105 days. This was at a time when processing time for cases at

OHA took approximately 386 days—more than a full year. Senior Attorney decisions

helped deserving claimants receive their benefits in a more timely fashion while simultaneously not wasting valuable agency resources.

Since the Senior Attorney Program was terminated, the backlog of cases has risen

at an alarming rate with almost 390,000 cases awaiting processing today. Without

the Senior Attorney Program these cases will wait about 314 days to be processed.

Even worse, the situation is expected to continue to deteriorate. There can be no

significant reduction in the case backlog or case processing time without reviving

this program. The Senior Attorney Program can help the agency address these problems with current resources and stem the decline in the quality of services nationwide. It does so without hiring new Administrative Law Judges and staff and it presents an immediate solution to a worsening problem. I urge you to question the

agency concerning this matter as soon as possible.

Thank you again for permitting NTEU to share our views on the needs of the

agencies within the jurisdiction of your Subcommittee.
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PREPARED STATEMENT OF THE AMERICAN PUBLIC POWER ASSOCIATION

The American Public Power Association (APPA) is the service organization representing the interests of the more than 2,000 municipal and other state and locally

owned utilities throughout the United States. Collectively, public power utilities deliver electric energy to one of every eight U.S. electric consumers (about 40 million

people) serving some of the nation’s largest cities. The majority of APPA’s member

systems are located in small and medium-sized communities in every state except

Hawaii. APPA member systems appreciate the opportunity to submit this statement

in support of fiscal year 2002 appropriations for the Low-Income Home Energy Assistance Program (LIHEAP).

APPA urges the Committee to support LIHEAP at its maximum funding level of

$2 billion in fiscal year 2002. APPA also supports a minimum of $300 million in

emergency funds in fiscal year 2002 and supports a funding level of at least $2 billion in advanced funding for fiscal year 2003. In addition, APPA supports the numerous amendments being considered in the Senate to increase the current $2 billion funding authorization level of LIHEAP. Because the majority of LIHEAP monies are needed during a short period of time in the winter months, advanced funding

for LIHEAP is critical in enabling states to effectively plan for and administer the

program. Moreover, a severe winter, escalating home heating oil prices in the Midwest and Northeast and higher than expected utility bills in California have depleted fiscal year 2001 emergency funds and highlight the important role LIHEAP

plays for the elderly and working poor during winter months and for all consumers

when energy prices are volatile.

Funding cuts since LIHEAP’s reauthorization in fiscal year 1995 have forced a

tightening of eligibility standards and, in some cases, significant reductions in benefit levels. According to the National Energy Assistance Directors’ Association

(NEADA), the primary educational and policy organization for state LIHEAP directors, the number of recipients has been cut by over one million households during

the recent past and average benefits have declined by about 10 percent. Prior to the

dramatic reduction in LIHEAP funding in fiscal year 1995, the program was serving

20 percent of the eligible population, with one-half of the recipients being elderly

or disabled Americans living on fixed incomes. Without the assistance provided by

LIHEAP, many would be forced to choose between paying their home energy bill or

purchasing other necessities of life, such as food.

As the debate over restructuring of the electric utility industry and the issue of

providing and funding ‘‘public benefits’’ programs continues, some have stated their

belief that electric utilities should assume the entire burden of energy assistance for

low income customers as a cost of doing business. As these restructuring efforts take

place at both the federal and state levels, the risks become greater that bills for residential customers, especially those with low incomes, will increase as retail markets are opened to competition. This prophesy has come true for consumers across

America this winter as we witness price spikes in all areas of fuel production, including natural gas, home heating oil and electricity. The need for full funding of

LIHEAP remains critical in ensuring that all those in need of energy assistance receive help. APPA believes that any public benefits programs should not replace or

supersede existing programs, such as LIHEAP, that are funded by federal appropriations.

APPA is proud of the commitment that its members have made to their low-income customers. Many public power systems have low-income energy assistance programs based on community resources and needs. APPA continues to remind its

members of how important it is to have in place a well designed low-income customer assistance program, in tandem with energy efficiency and weatherization programs, that can help consumers hold down their energy bills and lower their requirements for assistance.

In addition, the impact of welfare reform on energy assistance is just beginning

to be felt and LIHEAP is likely to play an important role in the transition. Persons

leaving the public assistance rolls are entering lower paying jobs and continue to

be confronted with large energy bills. These families remain at risk.

LIHEAP is one of the outstanding examples of a successful state-operated program. The requirements imposed by the federal government are minimal and most

important decisions are left to grantees.

APPA urges this Subcommittee’s favorable consideration of fiscal year 2002 funding for LIHEAP. Again, thank you for this opportunity to present our views.
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PREPARED STATEMENT OF THE ASSOCIATION OF AMERICA’S PUBLIC TELEVISION

STATIONS

The Association of America’s Public Television Stations submits this testimony to

the appropriations subcommittee on Labor Health and Human Services, Education

and Related Agencies. APTS, on behalf of the nation’s 354 local public television stations, urges the committee to support funding for the Corporation for Public Broadcasting and the Ready to Learn and TeacherLine projects within the Department

of Education.

This year APTS is asking Congress to fund the Corporation for Public Broadcasting in fiscal year 2004 at $395 million. This modest $30 million increase will

help pay for increases in system support such as royalties and copyright fees as well

as funds to support projects to develop new content for our increased educational

services and programming. Most significantly, this request would mean an average

increase of $90,000 per station in the form of Community Service Grants. Eighty

nine percent of CPB’s funding goes to local public television and radio stations in

the form of CSGs, which are the seed money for local operations. These federal

funds are leveraged an average of six fold to raise non-federal funds to enable local

stations to serve their local communities.

APTS thanks the committee for its generous past support and for acknowledging

the special needs of public broadcasting in the form of advanced appropriations. The

advance funding provision for CPB allows public broadcasting and local stations a

predictable source of support that can be applied to research and development. It

also provides the important lead time needed to leverage other funding sources necessary to bring programs to the air.

Public television also requests that the subcommittee provide funding for the

Ready to Learn program at $24 million and the TeacherLine project at $8.5 million

in fiscal year 2002. Both of these programs are administered through the Department of Education. The Ready to Learn program provides funding for the development and production of the highest quality children’s educational programming. It

also assists local stations in their outreach efforts to train teachers, parents and day

care providers to effectively use these programs to teach young children.

TeacherLine is an online professional development initiative that helps teachers improve their teaching skills in core subject areas.

Public broadcasting is also seeking equipment funds for the federally mandated

conversion to digital through the Public Telecommunications Facilities Program

(PTFP) within NTIA at the Department of Commerce.

COMMITMENT IN THE DIGITAL AGE

Public broadcasters historically have been the leaders in using new technologies

for education and public service. The nation’s public television stations stand ready

to make an historic commitment to all Americans to provide near universal access

to wireless, high-speed data for education. Specifically, public television stations will

commit the equivalent of one multicast digital channel—a daily average of 4.5

megabits per second (Mbps), among the highest data rates available—for formal

early childhood, K–12, and post-secondary education, as well as workforce training

and professional development. This digital capacity is conservatively valued at $2.4

billion per year.

HARNESSING DIGITAL TECHNOLOGY TO SERVE THE PUBLIC

With roots going back to the earliest days of radio and television, America’s public

broadcasters have played a unique role in a media industry that is otherwise built

on consumer advertising and mass market entertainment. Since the 1960s, publicly

funded noncommercial television has provided a clear alternative to commercial television, focusing on education and culture, public affairs and the performing arts.

While the proliferation of television channels has been driven by market demands,

public television’s core mission has not and will not change in a digital world. We

will build on our track record of providing the best programming and services to

educate and enlighten audiences. We also will continue to be leaders in using new

technology for the public interest. From satellite delivery of broadcast signals, to the

development of stereo broadcasting; from closed captioning and descriptive video

services, to video streaming and cutting edge interactive television trials, public

broadcasters have been inventors, innovators and blenders of technologies to serve

the public.

Public television is committed to use digital technologies to transform the way we

learn—by providing the American public with educational services anytime any-
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where. That means how they want them, when they want them and where they

want them—in homes, schools, childcare facilities, and workplaces across America.

MULTICAST DIGITAL SERVICES—UNLOCKING PUBLIC TELEVISION’S PUBLIC SERVICE

MISSION

Since receiving their digital channels, public television stations have been engaged in systemwide and station level planning. In 1997, public broadcasting put

forward a comprehensive plan for its digital conversion to the Administration and

Congress. We set four broad systemwide goals for the use of digital technology—

goals that are founded on fully utilizing the multicasting capability of the digital

technology to expand and enhance services.

To make the full complement of Ready to Learn services available to every child,

parent and caregiver in America.—The PBS Ready to Learn Service is currently

meeting two national education goals: it teaches basic reading skills and it helps

prepare more children for school success. Its 133 participating stations cover over

94 percent of the country. In the past three years, RTL public television stations

have trained 370,000 parents and 250,000 teachers and caregivers, affecting approximately 6 million children.

To expand the reach of public television’s K–12 educational programs and services

by making them universally available to all schools and home schoolers.—70 percent

of public television licensees provide K–12 programming in math, science, arts and

humanities. These services are enhanced by:

—PBS TeacherSource, an online K–12 teacher resource with online lesson plans,

teacher guides and activities, correlated to more than 90 national and state

standards; and,

—PBS Teacherline, online modules to enhance the learning and teaching of K–

12 mathematics and other core subjects.

To increase the reach of post secondary telecourses so that they are universally

available to all adult learners.—Collectively, public television stations are the largest source of post-secondary telecourses in the nation. PBS Adult Learning Service

(ALS) supports station-college partnerships that offer distance learning credit-bearing telecourses, enrolling more than 500,000 students in 1999–2000. GED on TV has

enabled more than two million adults in five years to earn their high school equivalency from home. The estimated positive economic impact of these more productive

workers exceeds $12 billion.

To expand our commitment to serving the unserved and underserved populations

in our country, those who because of economic, geographic, physical, cultural or language barriers have been left behind by the commercial marketplace.—Public Broadcasting has pioneered the development of open and closed captioning for the deaf

and descriptive video services and reading services for the blind or visually impaired. Stations like WYBE, Philadelphia and WNVC, Fairfax provide programming

in multiple languages serving a variety of different ethnic cultures.

Local public television stations throughout the country have turned those systemwide goals into concrete and very bold and exciting service plans tailored to their

local communities. APTS maintains an interactive clearinghouse of stations’ plans

for digital services. Our data show that virtually every public television station in

the country has developed digital service plans to meet these and other goals. The

centerpiece of virtually every plan is the delivery of multicast services with a strong

focus on education.

—In exchange for federal financial support and favorable cable must carry regulations, the nation’s public television stations stand ready to commit an average

daily rate of 4.5 megabits per second (approximately one channel) of their digital spectrum to education. The value of this capacity is conservatively estimated at $2.4 billion per year

—Three out of every four PTV stations plan to carry at least two formal education

multicast services.

—Approximately 85 percent of PTV stations plan to multicast a children’s channel; 78 percent intend to broadcast university-level or post-secondary telecourses; and 66 percent plan to multicast an instructional programming channel

for students in grades K–12.

—Others plan to multicast channels that focus on local public affairs, teacher

training, foreign language programming, and programming aimed at minority

and under-served audiences.
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PTV DIGITAL SERVICE PLANS—CREATING LOCAL SOLUTIONS FOR NATIONAL PRIORITIES

REALIZING NATIONAL EDUCATIONAL GOALS ON A LOCAL LEVEL

While public television stations plan to deliver one or more formal educational

multicast channel, the specific educational services are tailored to meet local community needs.

Florida public television stations have promised the state legislature that they

will collectively devote a multicasting stream to the Florida Knowledge Network in

return for digital funding. This statewide educational network will serve as a teacher training resource, linking Florida’s classrooms with direct access to the highest

quality programming, electronic field trips, and distance learning.

New York’s public television stations plan to dedicate one of their multicast

streams to an educational service called the Empire State Channel. Developed with

the state Department of Education, the Empire State Channel will feature teacher

training, vocational instruction and public affairs programming.

PROVIDING UNSERVED AND UNDERSERVED WITH ACCESS TO DIGITAL TECHNOLOGY

Today, public television stations, through their nationwide system of transmitters

and translators, serve 99 percent of American households with an over-the-air analog signal. Public television stations that serve rural communities with a network

of analog translators are ideally positioned to bring the benefits of broadband digital

services to the most rural and remote areas of this country.

KAET in Phoenix plans to partner with KUAT in Tucson to dedicate one or two

multicasting channels to feeding math, science, geography and other educational

programming to 300 schools throughout the geographically diverse state. Directed

by the stations and funded by the state Department of Education and Arizona State

University, programming will relate directly to course materials, and teacher training will be accompanied by curriculum guides, instructional materials, and planning

booklets that can be downloaded to computers in the classrooms. These services are

intended to reach students in the farthest corners of Arizona, students who are unable to be linked via telephone and fiber optic lines.

KNME in Albuquerque is considering leasing part of its digital spectrum to the

New Mexico Department of Education to facilitate the delivery of educational materials to the state’s K–12 schools. The station will position itself as the state’s virtual

classroom, providing curricular support and teacher training opportunities for viewers separated by hundreds of miles. This arrangement would allow the Department

of Education to help with the costs of digital conversion.

Public television stations also plan to use the multicast capability to serve populations under-served because of cultural, language or economic barriers.

KBDI in Denver plans to launch a Latino Initiative Channel. This channel would

feature programming for Denver’s Spanish-speaking and bilingual community and

will emphasize news, public affairs, and social and cultural events. Potential partners include local community service organizations, schools, commercial Spanishlanguage broadcasters, and public service agencies.

WNYE in Brooklyn and WYBE in Philadelphia plan to provide multicast foreign

language and international channels to serve the international residents in their respective cities. The WNYE multicast channel will feature programming in at least

12 different languages, including Japanese, Chinese, Italian, Greek, Polish, and

Eastern European languages.

PARTNERING WITH LOCAL INSTITUTIONS TO SOLVE LOCAL COMMUNITY PROBLEMS

A key characteristic of public television’s digital planning is localism. In an age

of increasing media consolidation, public television stations remain the only locally

owned, locally operated television service in many communities. Consequently, several PTV stations are planning ‘‘local’’ channels, focusing on specific community

needs.

Vermont Public Television plans a Vermont Public Service Channel, which would

provide regular coverage of the state legislature, important legislative committee

hearings and other statehouse-related programs, as well as local government town

meetings and debates. Additional programming might include call-in programs with

the Vermont congressional delegation, travel and tourism information, and other

local news and public affairs programming.

The federal government must play its historic leadership role in underwriting a

portion of public broadcasting’s digital transition. The government’s failure to make

this investment will have direct consequences. Millions of Americans may be deprived of the enormous educational promise of digital television. Many of the smaller and rural stations may be unable to make the transition at all.
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The public broadcasting industry has updated its costs for the digital transition.

Balancing reductions for the stations currently on the air against additions for increased costs, public broadcasters estimate the total costs of conversion for both television and radio at $1.8 billion.

CONCLUSION

For more than 30 years Congress has invested wisely in public broadcasting. We

now have a strong system of public television stations that reaches 99 percent of

American households, giving viewers tools to improve and enrich their lives. The

public service promise of new digital technology is enormous:

—for children to provide a dedicated stream of nonviolent, educational and entertaining programs, commercial-free and free-of-charge;

—for parents and schools to better educate children;

—for colleges and universities to reach out beyond their campus walls;

—for students of all ages to have access to lifelong learning;

—for under-served audiences whose income, geography, culture or disability

threatens to cut them off from the digital promise;

—for citizens who feel alienated from their local, state or federal governments;

and

—for public service organizations seeking to build a sense of civic connection and

commitment.

Realizing this potential and remaining a viable service provider in the digital age

is fully dependent on a federal investment to ensure access to all digital services.

Public television stands ready with service plans, matching state and local grants,

and community-based content partners to fully utilize this technology for public

service.

Funding for the Corporation for Public Broadcasting and through the Ready to

Learn and TeacherLine programs at the Department of Education will provide essential financial assistance to stations in order to meet their digital service goals.

PREPARED STATEMENT OF THE MOTION PICTURE & TELEVISION FUND

Funding is requested by the Motion Picture & Television Fund (MPTF), Woodland

Hills, California, in fiscal year 2002 appropriations, for an ‘‘Eden Alternative’’ demonstration project.

Nursing homes and assisted living facilities play a critical role in the delivery of

care to older people with chronic needs. It is expected that over half of the people

who turned 65 in 1990 will enter such a facility before they die. Too often the stay

is characterized by feelings of helplessness, loneliness and boredom. It is presumed,

but untested, that these ultimately add to the cost of care because of an increase

in hospitalizations, medical problems, and the use of psychotropic drugs. Any program that can reduce the frequency of those problems would have major implications through a reduction of Federal expenditures for health programs, including

Medicare and Medicaid.

The Eden Alternative is an innovative approach which was developed as a way

to improve the quality of life of nursing home and assisted living residents. This

approach seeks to overcome the problems of helplessness, loneliness, and boredom.

It is intended to improve quality of life and decrease medical problems and expense

through changes in the physical, psycho-social, and staffing environments. MPTF,

by this proposed demonstration project, seeks to validate that improvement in both

health outcomes and medical cost reductions can be achieved by implementing the

‘‘Eden Alternative’’ concept in its nursing home and assisted living community. A

demonstration project of this type can serve as a model for other similar community

based facilities nationwide.

The Federal Government and the Congress have a significant interest and responsibility in the quality of life and access to long term care by its older adults. This

responsibility is particularly relevant when in the near future the aging baby-boom

generation will substantially increase the number of United States citizens in retirement. By the year 2030, all baby-boomers will be over 65 years old, with the oldest

nearing age 85. Twenty percent of the total United States population will be elderly

in thirty years, compared with 13 percent today, 20 percent of all those over 85

years old will be residing in nursing homes. Since most, if not all, of these nursing

home residents will be on Medicare, the nationwide impact of a program which significantly reduces medical costs should be a priority item of interest and responsibility.

The Eden Alternative offers a paradigm shift that seeks to transform the concept

of institutional care. A central tenet is that the environment should help maximize
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individual potential for personal growth by offering variety, vibrancy and spontaneity. This approach includes homelike furnishings, regular interaction with children and young adults, resident responsibility for the care of companion animals

and plants, and flexibility in residents’ daily activities to encourage spontaneity.

Perhaps most important is staff development which facilitates the replacement of

top down bureaucratic authority with decision making that is closest to the resident,

whenever possible. Staff needs to be provided with the necessary training, skills and

information, in order to assume responsibility for the improved social and medical

outcomes. The change in surroundings results in an enhanced sense of self, a higher

quality of life, and a relief from the problems that frequently affect nursing home

and assisted living residents.

In addition to a plethora of environmental changes, the Eden Alternative also promotes substantive changes in management philosophy and style and organizational

culture. Management principles include:

—Replacing top down bureaucratic authority with decision making that is closest

to the consumer whenever possible. This includes empowering residents and

those who provide the most direct care and transforming the roles of staff to

family-like companions rather than medical care providers.

—Encouraging leadership that embraces change which is focused on improving

residents’ quality of life. To support necessary changes in the physical and work

environment, leaders assume the role of coaches. Leaders and staff are encouraged to reward appropriate risk-taking, promote fundamental fairness, and recognize that mistakes are part of change.

—Organizing work through self-directed work teams in contrast to hierarchy and

strict departmental lines. To ensure informed decision making, team members

are provided with necessary information, resources, training and skills, knowledge, and a supportive environment. Thus empowered, teams are responsible

for making decisions about how to meet their goals including scheduling and organizing their work.

These innovations are believed to create a more desirable environment for residents and staff and to result in improved health status for residents. In addition

to the relief of boredom and helplessness that afflicts residents, preliminary work

suggests that such an enriched habitat improves residents’ quality of life and leads

to such related benefits as reducing prescription mediation use; reduced incidence

of infections, skin breakdowns, and falls; less depression; and improved sense of well

being and control. Studies have also suggested that an enriched environment positively affects staff, resulting in less absenteeism, reduced turnover, and higher levels of job satisfaction.

MPTF goals for this project are two-fold: (1) Implement the environmental and

staff changes necessary to achieve the life style envisioned by the Eden Alternative

(including programmatic changes and staff training); and (2) Measure and report on

specific parameters related to quality of life and decreased medical resource consumption. These parameters would include the use of psychotropic drugs, the presence of skin ulcers, falls, and hospitalizations. In addition, national data on specific

outcomes in nursing homes has been collected for several years. Our experience will

be compared to these national benchmarks. We believe that this demonstration

project will confirm significant financial savings for our residents and that these

savings will be applicable to Medicare and Medicaid if this effort is adopted nationally. Once confirmed, we would share our experience and teach other organizations

how to effectively implement the operating principles of the Eden Alternative.

MPTF is an 80-year old non-profit health and social service organization which

serves the Southern California entertainment community. Among our services are

a 195 bed long-term care facility and a retirement community (independent and assisted living) of 120. In the first quarter of 2002, we will be opening additional retirement housing with a capacity of 95. Our residents are admitted regardless of

their ability to pay. It is because of our history of providing the highest quality of

life in the most cost-effective way possible that we seek support for this transition

in our care model.

PREPARED STATEMENT OF THE NATIONAL FEDERATION OF COMMUNITY BROADCASTERS

Thank you for the opportunity to submit testimony to this Subcommittee regarding the appropriation for the Corporation for Public Broadcasting (CPB). As the

President and CEO of the National Federation of Community Broadcasters I speak

on behalf of 150 community radio stations across the country. NFCB is the sole national organization representing this group of stations which provide service in the

smallest communities of this country as well as the largest metropolitan areas.
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Nearly half of our members are rural stations and half are minority controlled stations.

In summary, the points we wish to make to this Subcommittee are that NFCB:

—Requests $395 million CPB for fiscal year 2004, a $30 million increase over fiscal year 2004 funding;

—Requests that advance funding for CPB is maintained to preserve journalistic

integrity and facilitate planning and local fundraising by public broadcasters;

—Requests report language to ensure that CPB utilizes digital funds it receives

for radio as well as television needs;

—Supports CPB activities in facilitating programming services to Latino and Native American radio stations;

—Supports CPB’s efforts to help public radio stations utilize new distribution

technologies and requests that the Subcommittee ensure that these technologies

are available to all public radio services and not just the ones with the greatest

resources. Community radio fully supports $365 million for the Corporation for Public Broadcasting in fiscal year 2004.—Federal support distributed through the CPB is an essential resource for rural stations and for those stations serving minority communities. These stations provide critical, life-saving information to their listeners. Yet

they are often in communities with very small populations and limited economic

bases so that the ability of the community to financially support the station is insufficient without federal funds.

In larger towns and cities, sustaining grants from CPB enable community radio

stations to provide a reliable source of noncommercial programming about the communities themselves. Local programming is an increasingly rare commodity in a nation that is dominated by national program services and concentrated ownership of

the media.

For the past 25 years, CPB appropriations have been enacted two years in advance. We are grateful for Senators Spector and Steven’s comments in support of

continuing the advance appropriations. This insulation has allowed pubic broadcasting to grow into a respected, independent, national resource that leverages its

federal support with significant local funds. Knowing what funding will be available

in advance has allowed local stations to plan for programming and community service and to explore additional non-governmental support to augment the federal

funds. Most importantly, the insulation that forward-funding provides ‘‘go[es] a long

way toward eliminating both the risk of and the appearance of undue interference

with and control of public broadcasting.’’—House Report 94–245.

In the last two years, CPB has increased support to rural stations and committed

resources to helping public radio take advantage of new technologies such as the

internet and satellite radio. We commend these activities which we feel provide better service to the American people, but want to be sure that the smaller stations

with more limited resources are not left out of this technological transition. We ask

that the Subcommittee include language in the appropriation that will ensure that

funds are available to help the entire public radio system utilize the new technologies, particularly rural and minority stations.

NFCB commends CPB for the leadership it has shown in supporting and fostering

the programming services to Latino stations and to Native American stations.

Sate ́lite Radio Bilingu ̈ e provides 24 hours of programming to stations across the

United States and Puerto Rico addressing issues of particular interest to the Latino

population. In the same way, American Indian Radio on Satellite (AIROS) is distributing programming for the Native American stations, arguably the fastest growing

groups of stations. There are now over 30 stations controlled by and serving Native

Americans, primarily on Indian reservations.

CPB plays a very important role for the public and community radio system. They

are the convener of discussions on critical issues facing us as a system. They support research so that we have a better understanding of how we are serving listeners. And they provide funding to programming, new ventures, expansion to new

listeners, and projects that improve the efficiency of the system. This is particularly

important at a time when there are so many changes in the radio and media environment with new distribution technologies and media consolidation.

Finally, community radio supports funding for conversion to digital broadcasting

by public radio and television.—While public television’s needs are more immediate,

the Federal Communications Commission is now in the process of identifying a

standard for digital radio transmission. We expect that there will be funds available

for radio conversion as well as television conversion. More immediately, the television conversion process is already having an impact on public radio stations. As

television stations increase the space they need on their towers to accommodate

both analog and digital signals, radio stations that rent space on TV towers are los-
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ing their leases and being forced to move to other towers—sometimes with very

short notice. This situation will only get worse over the next year as we approach

the FCC deadline for television conversion. We would like to see emergency funding

to help public radio stations who lose their tower space do the necessary engineering

studies and move to new tower locations.

We appreciate Congress’ direction to CPB that it utilize its digital conversion fund

for both radio and television and ask that you ensure that the funds are used for

both media. Congress stated, with regard to fiscal year 2001 digital conversion

funds:

‘‘The required (digital) conversion will impose enormous costs on both individual

stations and the public broadcasting system as a whole. Because television and

radio infrastructures are closely linked, the conversion of television to digital will

create immediate costs not only for television, but also for public radio stations (emphasis added). Therefore, the Committee has included $15,000,000 to assist radio

stations and television stations in the conversion to digitalization . . .’’ (S. Rpt. 105–

300)

This is a period of tremendous change. Digital is transforming the way we do

things; new distribution avenues like digital satellite broadcasting and the Internet

are changing how we define the business we are in; the concentration of ownership

in commercial radio makes public radio and particularly community radio, more

unique and more important as a local voice than we have ever been. During this

time, the role of CPB as a convener of the system becomes even more important.

And the funding that it provides will allow the smaller stations to participate along

with the larger stations who have more resources, as we move into a new era of

communications.

Thank you for your consideration of our testimony.

PREPARED STATEMENT OF THE NATIONAL MINORITY PUBLIC BROADCASTING

CONSORTIA

The National Minority Public Broadcasting Consortia (Minority Consortia) submits this statement on the fiscal year 2004 appropriation for the Corporation for

Public Broadcasting (CPB). Our primary missions are to bring a significant amount

of programming from our communities into the mainstream of PBS and public

broadcasting. In summary, we ask the Committee to:

—Reject the Administration’s proposal to end forward funding of the Corporation

for Public Broadcasting —Recommend at least $395 million for CPB for fiscal year 2004, a $30 million

increase over fiscal year 2003

—Encourage CPB to increase its efforts for diverse programming with commensurate increases for minority programming and the Minority Consortia —Support the Administration’s request of $20 million for digital conversion

The National Minority Public Broadcasting Consortia consists of the National

Asian American Telecommunications Association, the National Black Programming

Consortium, Native American Public Telecommunications, Pacific Islanders in Communications and the Latino Public Broadcasting Project

Forward Funding.—We strongly oppose the Administration’s proposal that the advance funding for CPB be eliminated, a proposal that would stop CPB funding for

two years. We were pleased to see the colloquy on the Senate floor April 6 between

Senators Stevens and Specter concerning this issue, and we support any efforts to

continue the practice of two years forward funding for CPB. Reasons to continue forward funding for CPB include:

—The production of programming for public broadcasting usually takes several

years and substantial lead time is needed for planning.

—Public broadcasting programs are supported by multiple funding sources, and

two years advance knowledge of the amount of federal funding allows CPB to

better leverage its federal funds to bring in other sources of revenue.

—The Minority Consortia administers a significant amount of CPB programming

monies, and elimination of forward funding would negatively affect our organizations’ planning and fundraising activities.

CPB Appropriation.—We support a fiscal year 2004 federal appropriation for CPB

of at least $395 million. This would be a reasonable, albeit modest, contribution toward our national treasure of public broadcasting. The debate of the past several

years regarding public television and public radio has highlighted the great esteem

in which they are held.

Public broadcasting, including PBS and NPR, is particularly important for minority and ethnic communities. While there is a niche in the commercial broadcast and
701

cable world for quality programming about our communities and our concerns, it is

in the public broadcasting industry where minority communities and producers are

more able to bring quality programming for national audiences. Additionally, public

television and radio is universally available.

Digital Conversion Assistance.—We support the Administration’s request for $20

million for digital conversion funding for CPB. We also urge Congress to enact the

necessary authorizing legislation so that these funds can be distributed.

With stations able to broadcast on multiple channels, there will be a need for a

tremendous amount of new, quality public broadcasting programming. There are

costs involved in the conversion which go beyond the significant equipment and

hardware needs of stations. It will also take additional money to produce programming for digital broadcast. All producers will face these new, higher costs.

Part of the equation in bringing more high quality diverse programming to public

broadcasting is that independent producers be able to transition to digital production. Federal funding for digital conversion should include assistance for independent producers.

The Minority Consortia works closely with CPB. We value our relationship with

President Coonrod and the CPB staff and appreciate the financial and technical assistance provided to us by that organization. We do not doubt CPB’s commitment

to increasing the diversity of programming on public television and radio but also

believe they can do more with the resources at hand. The oft-stated commitment

of CPB and Congress for increased multicultural programming combined with four

years of funding increases make this an ideal time for significant progress.

Thank you for your consideration of our recommendations. We see new opportunities to increase diversity in programming, production, audience, and employment in

the new media environment, and thank you for your long time support of our work

on behalf of our communities.

PREPARED STATEMENT OF THE NATIONAL PUBLIC RADIO

INTRODUCTION

Thank you for the opportunity to submit a statement for the hearing record on

behalf of National Public Radio (NPR) and the hundreds of public radio stations

that air NPR programming across the country. Public radio offers diverse perspectives by airing a combination of local and national public affairs and cultural programming, funded by local and national sources, both public and private. Public

broadcasting raises nearly 85 percent of its funding from non-federal sources, yet

it requires help from federal sources to fully achieve its programming mission.

Public broadcasters seek a $395 million appropriation for CPB in fiscal year 2004

(for the past quarter century, CPB has received appropriations two years in advance).—The CPB was established in 1967 to provide federal support to stations. A

$395 million funding level for the annual CPB appropriation would provide an additional $6.7 million for radio over last year. Of that $6.7 million, $5.2 million would

be available for local public radio stations to keep pace with technological changes

and to produce and to acquire content for a number of technological platforms and,

$1.5 million would allow CPB to fund 10–15 new radio production projects in fiscal

year 2004.

Public broadcasters urge the Subcommittee to maintain advance appropriations for

CPB.—The Administration and the House and Senate budget resolutions have proposed to eliminate this long-standing practice that preserves freedom of expression,

affords program managers more lead time to plan and organize activities, and provides seed money for raising non-federal money.

Public broadcasters support the Bush Administration’s request for $20 million in

fiscal year 2002 for local stations’ transition to digital technology.—The estimated

cost for digital radio is $116 million for transmission only, excluding production

equipment.

Thank you for your commitment to our nation’s public broadcasters, and the citizens and communities they serve.

A COMMITMENT TO LOCAL AND NATIONAL SERVICE

Public radio stations are committed to serving their local communities for philosophical, geographical and financial reasons.

Philosophically, non-profit public radio stations’ missions are to serve their local

communities with a variety of programs and perspectives. For instance, the mission

of WDUQ–FM in Pittsburgh, PA states, ‘‘WDUQ is a noncommercial, educational

public radio station licensed to Duquesne University. As a steward of this license,
702

WDUQ serves Duquesne, listeners and the community with high quality programming and services to inform, educate, enlighten and entertain.’’

As a result of these guiding missions, many public radio stations provide listeners

with more than headlines and traffic reports by building local news departments

that produce in-depth reports on community issues. Moreover, stations air national

and international programming that connects listeners to broader sources of ideas,

cultures and events.

Geographically, stations are licensed locally and make all significant operational

and programming decisions. In fact, stations are often the only locally owned media

outlets in their communities. NPR Members include stations licensed to communities, local school boards and other local institutions, and private and public colleges and universities. Specifically, 78 of NPR’s Member licensees are local communities (including several Native American tribes). In addition, 8 are school boards,

11 are state entities, 27 are private universities, and 146 are state universities.

Public broadcasting has been a grassroots movement, joining diverse regions and

viewpoints around a common purpose of community service and education. Because

public radio’s foundation was built by and is maintained by local decision-makers

and listeners, this local nature preserves accountability to the people in the listening community.

This support is also reflected in the personal support dedicated by listeners and

viewers to their local stations. For instance, according to CPB, replacing the work

that volunteers contribute to public television stations would require nearly an eight

percent increase in full-time staff, and for public radio more than a 14 percent increase.

Financially, public broadcasters are part of a successful public-private partnership. Nearly 85 percent of public radio’s funding comes from non-federal sources.

Stations are supported by a variety of sources, including government, foundations,

businesses and listeners. Currently, local stations’ listeners generally provide the

largest percentage of funding (approximately one third) for local stations.

Nevertheless, federal money is crucial because it helps public radio stations plan,

produce, acquire and air programs that attract these non-federal funding sources.

CPB funding acts as ‘‘seed money’’, raising $6 of non-federal money for every $1 of

federal funding.

A statutory formula governs all federal appropriations distributed through CPB.

Public television receives 75 percent of the CPB appropriation while radio receives

25 percent. 93 percent of the radio designated federal money goes directly to local

communities. The other 7 percent of radio funds remain at CPB to support national

radio programming, which is awarded on a competitive basis. This money is essential to support the unrivaled services public radio stations bring to their communities.

ADVANCE APPROPRIATION FOR CPB

President Bush’s budget document calls for a series of reforms to the federal budget process, one of which is targeted on the ‘‘abusive’’ use of advance appropriations

for short-term budgeting purposes rather than for ‘‘advanced appropriations enacted

for programmatic . . .’’ The President’s policy of limiting advance appropriations is

reflected in the House and Senate budget resolutions. This cap will effectively preclude any advance appropriation to CPB for fiscal year 2004.

During the April 6, 2001 Senate debate of the budget resolution, however, Senate

Appropriations Committee Chairman Ted Stevens (R-AK) and Senate Labor/HHS

Appropriations Subcommittee Chairman Arlen Specter (R-PA) expressed their concerns regarding the elimination of CPB’s advance appropriations. NPR and its Member stations sincerely thank these two Senators and strongly support this effort to

maintain advance funding for CPB.

Advance funding preserves journalistic integrity by insulating CPB from reactions

to programming decisions. Advance appropriations also afford program managers

more lead-time to plan and organize their activities. Moreover, advance appropriations provide seed money for raising non-federal funding. Ordinarily, the decision

to advance fund a program is driven by a desire to insulate that program from the

uncertainties surrounding the annual appropriations process, such as delays in enacting appropriations. Legislative history shows that it was this reasoning that led

Congress—backed by the recommendations of three presidents—to place CPB on an

advance appropriation basis beginning in 1976. In fact, in 1975, President Ford sent

a five-year reauthorization to Congress with a five-year advance funding provision.

Subsequently in 1976, the Congress, in a bipartisan vote, established a three-year

funding practice with two-year advance appropriations that has supported CPB ever

since (Public Law 94–439).
703

DIGITAL RADIO CONVERSION

Like our friends in public television, NPR and its member stations are excited

about the possibilities of digital service and ‘‘new media.’’ Public radio supports

President Bush’s budget proposal that earmarks $20 million in fiscal year 2002 for

CPB to help facilitate public radio and television’s transition to digital broadcasting.

The estimated cost for digital radio is $116 million for transmission only, excluding

production equipment.

Digital radio transmission technology is poised to deliver near compact-disc-quality sound free of interference to listeners. Digital production and transmission conversion will enable public radio stations to produce and deliver programming using

a far more efficient process than currently exists. It may allow listeners and users

to experience a variety of new services such as the ability to search program formats, scan selective programs and read music lyrics and song titles.

U.S. broadcasters are developing a digital technology that works in the existing

AM and FM radio bands named In-Band, On-Channel or ‘‘IBOC.’’ The Federal Communications Commission (FCC) initiated a digital audio broadcasting, or ‘‘DAB,’’

rulemaking in November 1999, placing a high priority on preserving spectrum.

IBOC DAB achieves spectrum preservation by combining digital and analog signals

within the same AM or FM radio channel, thereby avoiding the need for additional

spectrum.

The National Radio Systems Committee (NRSC) will independently test IBOC

DAB in the Summer 2001. At some point after evaluation of the additional testing,

the NRSC is expected to make a recommendation to the FCC on the selection of

a standard. The FCC is awaiting this industry recommendation before it endorses

a digital transmission standard.

NATIONAL SUPPORT FOR LOCAL EFFORTS: CPB FUNDED PROGRAMS

The majority of CPB dollars go to local stations to help sponsor community outreach activities, create local programming and purchase national programming from

a diverse set of content producers. The following are a few of the many examples

of the local and national programming that are supported in part by CPB funding:

KSKA–FM in Anchorage, AK.—Produces Community Forum. Host Robert Howk

and his guests discuss community issues and take listener calls during this live,

call-in broadcast. The station also partners with other Alaskan public radio stations

to produce and broadcast Alaska Edition, an award-winning daily radio magazine.

It is an hour-long mix of news, interviews, music and commentaries written, produced and hosted by Alaskans for Alaskans.

KPBS in San Diego, CA.—Partnered with the California League of Women in the

last election season to offer voters personalized election information. Along with locally produced news stories, the feature contained a sample ballot with candidate

profiles, proposition information, links to voter registration and polling place information. Users could create their own portfolio of election information and stories

that interested them.

WOI Radio in Ames, IA.—Partners with St. John’s Lutheran Church Foundation,

Essman/Associates to produce St. John’s Forum, a series devoted to promoting civil

discourse on ethical questions and other issues facing Iowans. Beginning its third

season on WOI Radio, The Forum is recorded before a live audience at WOI’s studios in the Iowa State University Learning Connection in downtown Des Moines.

WFPL–FM in Louisville, KY.—Broadcasts Louisville Forums, programming that

helps Louisville citizens learn about local issues and ideas from people in the community. WFPL–FM broadcasts presentations at the Downtown Rotary Club, the

Louisville Forum, the University of Louisville, the Louisville Free Public Library

and other local venues. The station also produces State of Affairs, a program offering substantive discussion with an inquisitive host, informed guests and thoughtful

callers covering topics as diverse as politics and economic development, to social

issues, religion and arts.

New Hampshire Public Radio.—Produces Front Porch with John Walters, a program dedicated to hearing from the Granite State’s most interesting people with a

unique, creative approach to their work or their life.

KNPR–FM in Las Vegas, NV.—Produces The Las Vegas I Remember, a series devoted to the history of Las Vegas and Nevada told by those who lived it. For instance, the program featured members of three of Las Vegas’ founding families. Another program examined the history of Las Vegas after the building of the Hoover

Dam.

WVIA–FM in Scranton, PA.—Broadcasts performances of artists who perform and

record in the magnificent space of St. Stephen’s Pro-Cathedral in Wilkes-Barre. Past

performances have included organists, choral groups and chamber music. The sta-
704

tion also produces Art Scene, a unique program bringing attention to the area’s cultural events through interviews, reviews and commentaries on films, books, jazz,

and classical music.

KERA–FM in Dallas, TX.—Airs The People’s Agenda, a call-in show exploring

issues of public concern such as work, family, transportation and crime. The show

defines problems from the public’s perspective, examining how citizens are addressing local matters.

WXPR–FM in Rhinelander, WI.—Produces nearly a dozen programs such as

Northwoods Cafe ́, a mix of music from traditional, new and ethnic folk music, as

well as world music to some blues, cajun and zydeco music.

NPR’s.—Morning Edition is the premier national/local program on public radio,

with 10 million weekly listeners. The program is designed to encourage local stations’ news departments to report on community news and events by inserting these

stories into the national feed.

NPR’s.—Lost & Found Sound is a collection of stories that chronicles, reflects, and

celebrates the changing sounds of this century. Stories explore American life

through sound—endangered sounds, shifting accents, vanishing voices, the merging

of languages, the music of new technologies, and the soundscape of the streets.

NPR.—Distributes Latino USA, a national, English-language news and culture

program produced from a Latino perspective. It is a production partnership of KUT

Radio and the Center for Mexican American Studies at The University of Texas at

Austin.

CONCLUSION

Survey after survey finds that public broadcasting is valued and supported enthusiastically by leaders of both political parties and by Americans from all regions and

walks of life. According to Roper Starch Worldwide, a leading global marketing research and consulting firm, public television and public radio are among the top five

choices for government services that provide excellent or good value for the tax dollar.

Please support a $395 million appropriation for CPB for fiscal year 2004 and

maintain advance appropriations for CPB. Moreover, please support $20 million for

public radio and television’s digital transition that is contained in the President’s

budget.

NPR is a private, nonprofit corporation that produces and distributes award-winning programming such as Morning Edition, All Things Considered, Performance

Today, and Car Talk. NPR is also a membership organization. NPR Member stations are independent entities, licensed to a variety of non-profit organizations, local

communities, colleges, universities and other institutions. Public radio stations independently select and produce community-appropriate programming that best serve

their listening areas rather than having these decisions made by a centralized conglomerate.
(i)

LIST OF WITNESSES, COMMUNICATIONS, AND

PREPARED STATEMENTS

Page

Alexander, David C., president, Auburn Engineers, Inc ...................................... 169

Prepared statement .......................................................................................... 170

Alexander, Hon. Duane, M.D., Director, National Institute of Child Health

and Human Development, National Institutes of Health, Department of

Health and Human Services, prepared statement ............................................ 300

Alpha One Foundation, prepared statement ......................................................... 442

American Academy of:

Family Physicians, prepared statement ......................................................... 450

Physician Assistants, prepared statement ..................................................... 454

American Association of:

Geriatric Psychiatry, prepared statement ...................................................... 457

Colleges of Nursing, prepared statement ....................................................... 464

Colleges of Osteopathic Medicine, prepared statement ................................. 468

Colleges of Pharmacy, prepared statement .................................................... 470

Immunologists, prepared statement ............................................................... 462

Pharmaceutical Scientists, prepared statement ............................................ 471

American:

College of Cardiology, prepared statement ..................................................... 472

Council on Education Coalition for International Education, prepared

statement ....................................................................................................... 424

Dental Hygienists’ Association, prepared statement ..................................... 475

Gastrotenterological Association, prepared statement .................................. 482

Health Care Association, prepared statement ............................................... 25

Heart Association, prepared statement .......................................................... 485

Indian Higher Education Consortium, prepared statement ......................... 417

Library Association, prepared statement ....................................................... 684

Lung Association (ALA), prepared statement ................................................ 478

Museum of Natural History, prepared statement ......................................... 420

Psychological Society, prepared statement ..................................................... 489

Public Power Association, prepared statement .............................................. 693

Society for Microbiology, prepared statements.......................................... 498, 501

Society of Clinical Oncology, prepared statement .......................................... 494

Society of Clinical Pathologists, prepared statement .................................... 496

Society of Tropical Medicine and Hygiene, prepared statement .................. 504

Thoracic Society (ATS), prepared statement .................................................. 478

Association for Professionals in Infection Control and Epidemiology, Inc.,

prepared statement .............................................................................................. 507

Association of:

Academic Health Sciences Libraries, prepared statement ............................ 588

America’s Public Television Stations, prepared statement ........................... 694

Minority Health Professions Schools, prepared statement ........................... 508

Schools of Public Health, prepared statement ............................................... 444

Babyland Family Services, Inc., prepared statement ........................................... 511

Barondess, Dr. Jeremiah A., chairman, panel on Musculoskelatal Disorders

and the Workplace, and president of the New York Academy of Medicine .... 118

Prepared statement .......................................................................................... 120

Battey, Dr. James F., Jr., Director, National Institute on Deafness and Other

Communication Disorders, National Institutes of Health, Department of

Health and Human Services, prepared statement ............................................ 302

Bigos, Dr. Stanley, Professor of Orthopedics, University of Washington ........... 79

Prepared statement .......................................................................................... 81
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ii

Bonacum, Doug, director, Patient Safety, Kaiser Permanente ............................ 182

Prepared statement .......................................................................................... 184

Burton, Dr. Kim, director, Spinal Research Unit, University of Hudderfield,

United Kingdom ................................................................................................... 114

Prepared statement .......................................................................................... 116

Bushnell Center for the Performing Arts, prepared statement ........................... 422

Byrd, Hon. Robert C., U.S. Senator from West Virginia, questions submitted

by ........................................................................................................................... 289

Canavan Research Illinois, prepared statement ................................................... 514

Carper, Senator Thomas R., amendment proposed by ......................................... 280

Cassman, Dr. Marvin, Ph.D., Director, National Institute of General Medical

Sciences, National Institutes of Health, Department of Health and Human

Services, prepared statement .............................................................................. 305

Chao, Hon. Elaine L., Secretary of Labor, Office of the Secretary, Department

of Labor............................................................................................................... 68, 201

Letter from ........................................................................................................ 26

Prepared statements...................................................................................... 69, 206

Summary statement ......................................................................................... 203

Children’s Heart Foundation, prepared statement ............................................... 518

City of:

Miami Beach, FL, prepared statement ........................................................... 520

Newark, NJ, prepared statement .................................................................... 520

Coalition for Health Funding, prepared statement .............................................. 525

Coalition of Northeastern Governors, prepared statement .................................. 528

Cochran, Hon. Thad, U.S. Senator from Montana:

Opening statement ........................................................................................... 379

Question submitted by ..................................................................................... 249

College on Problems of Drug Dependence, Inc., prepared statement .................. 530

Collins, Dr. Francis S., M.D., Ph.D., Director, National Human Genome Research Institute, National Institutes of Health, Department of Health and

Human Services, prepared statement ................................................................ 307

Colonial Williamsburg Foundation, prepared statement ..................................... 427

Community Medical Centers, Fresno, CA, prepared statement .......................... 532

Council of State and Territorial Epidemiologists, prepared statement ............... 533

Craig, Hon. Larry E., U.S. Senator from Idaho, question submitted by ............. 283

Crohn’s and Colitis Foundation of America, prepared statement ....................... 537

Crownpoint Institute of Technology, prepared statement .................................... 439

Cure for Lymphoma Foundation, prepared statement ......................................... 540

Dean, Hon. Donna J., Ph.D., Acting Director, National Institute of Biomedical

Imaging and Bioengineering, National Institutes of Health, Department

of Health and Human Services, prepared statement ........................................ 311

Derebery, Dr. Jane, vice president of Medical Affairs, Concentra Medical

Services ................................................................................................................. 136

Prepared statement .......................................................................................... 137

Digestive Disease National Coalition, prepared statement .................................. 541

Doris Day Animal League, prepared statement .................................................... 544

Drug and Alcohol Service Providers Organization of Pennsylvania, prepared

statement .............................................................................................................. 578

Dystonia Medical Research Foundation, prepared statement ............................. 545

Easter Seals, prepared statement .......................................................................... 547

Eberhardt, Heidi, international trade specialist ................................................... 107

Prepared statement .......................................................................................... 109

Epilepsy Foundation, prepared statement ............................................................. 552

Evanoff, Dr. Bradley, assistant professor of medicine, Washington University

School of Medicine ................................................................................................ 97

Prepared statement .......................................................................................... 99

Facioscapulohumeral Muscular Dystrophy Society, prepared statement ........... 553

Families of Spinal Muscular Atrophy, prepared statement ................................. 559

Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infectious

Diseases, National Institutes of Health, Department of Health and Human

Services ................................................................................................................. 293

Prepared statement .......................................................................................... 313

Feinstein, Hon. Dianne, U.S. Senator from California, questions submitted

by ........................................................................................................................... 291
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Fellner, Baruch A. Esq., Partner, Gibson, Dunn & Crutcher, LLP ............. 1, 76, 196

Prepared statement .......................................................................................... 78

Ficca, Stephen A., Associate Director for Research Services, National Institutes of Health, Department of Health and Human Services, prepared

statement .............................................................................................................. 316

Florida State University, prepared statement ...................................................... 430

Foundation for Ichthyosis & Related Skin Types, prepared statement .............. 557

Frumin, Eric, director, Safety and Health, Union of Needle Trades Industrial

and Textile Employees ......................................................................................... 175

Prepared statement .......................................................................................... 177

Gordis, Hon. Enoch, M.D., Director, National Institute on Alcohol Abuse

and Alcoholism, National Institutes of Health, Department of Health and

Human Services, prepared statement ................................................................ 318

Grady, Dr. Patricia A., Director, National Institute of Nursing Research,

National Institutes of Health, Department of Health and Human Services,

prepared statement .............................................................................................. 321

Hadler, Dr. Nortin M., professor of Medicine and Microbiology/Immunology,

University of North Carolina, Chapel Hill ......................................................... 83

Prepared statement .......................................................................................... 85

Harkin, Hon. Tom, U.S. Senator from Iowa:

Opening statements ................................................................................ 28, 66, 252

Prepared statements.................................................................................. 202, 390

Questions submitted by ............................................................... 59, 238, 284, 404

Hepatitis Foundation International, prepared statement .................................... 560

Hodes, Dr. Richard J., Director, National Institute on Aging, National Institutes of Health, Department of Health and Human Services .......................... 293

Prepared statement .......................................................................................... 324

Hollings, Hon. Ernest F., U.S. Senator from South Carolina, questions submitted by ............................................................................................................... 407

Humane Society of the United States, prepared statement ................................. 562

Huntington’s Disease Society of America, prepared statement ........................... 564

Hutchison, Hon. Kay Bailey, a U.S. Senator from Texas, questions submitted

by ........................................................................................................................... 408

Hyman, Hon. Steven E., M.D., Director, National Institute of Mental Health,

National Institutes of Health, Department of Health and Human Services,

prepared statement .............................................................................................. 329

Immune Deficiency Foundation, prepared statement ........................................... 565

Infectious Diseases Society of America’s (IDSA), prepared statement ................ 567

Joslin Diabetes Center, prepared statement ......................................................... 571

Juvenile Diabetes Research Foundation International, prepared statement ..... 573

Katz, Dr. Stephen I., Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Department of

Health and Human Services ............................................................................... 293

Prepared statement .......................................................................................... 332

Kennedy Krieger Institute, prepared statement ................................................... 574

Keusch, Gerald T., M.D., Director, John E. Fogarty International Center

for Advanced Study in the Health Sciences, National Institutes of Health,

Department of Health and Human Services, prepared statement .................. 334

Kirschstein, Hon. Ruth L., M.D., Acting Director, National Institutes of

Health, Department of Health and Human Services ........................................ 293

Prepared statement .......................................................................................... 296

Summary statement ......................................................................................... 295

Klausner, Dr. Richard D., Director, National Cancer Institute, National Institutes of Health, Department of Health and Human Services .......................... 293

Prepared statement .......................................................................................... 337

Landrieu, Hon. Mary L., U.S. Senator from Louisiana:

Opening statement ........................................................................................... 112

Questions submitted by ................................................................................... 287

Lenfant, Dr. Claude, Director, National Heart, Lung and Blood Institute,

National Institutes of Health, Department of Health and Human Services .. 293

Prepared statement .......................................................................................... 340
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iv

Leshner, Alan I., Ph.D., Director, National Institute on Drug Abuse, National

Institutes of Health, Department of Health and Human Services, prepared

statement .............................................................................................................. 345

Lindberg, Dr. Donald A.B., Director, National Library of Medicine, National

Institutes of Health, Department of Health and Human Services, prepared

statement .............................................................................................................. 343

Lippy, Dr. William H., prepared statement .......................................................... 681

Lovelace Respiratory Research Institute (LRRI), prepared statement ............... 581

LPA, Inc., prepared statement ............................................................................... 20

Lymphoma Research Foundation of America, Inc., prepared statement ............ 582

Maddox, Dr. Yvonne T., Acting Deputy Director, Office of the Director, National Institutes of Health, Department of Health and Human Services,

prepared statement .............................................................................................. 348

McLaughlin, Dr. Jack A., Acting Director, National Eye Institute, National

Institutes of Health, Department of Health and Human Services .................. 293

Prepared statement .......................................................................................... 351

McMullen, James, Deputy Assistant Secretary, Budget, Department of

Labor ..................................................................................................................... 201

Medical Library Association, prepared statement ................................................ 588

Medicare Payment Advisory Commission, prepared statement .......................... 584

Miami Children’s Hospital, prepared statement ................................................... 592

Mirer, Dr. Franklin E., director, Health and Safety, United Auto Workers ...... 150

Prepared statement .......................................................................................... 151

Mississippi:

Department of Rehabilitation Services, prepared statement ........................ 594

State University, prepared statement ............................................................ 523

Motion Picture & Television Fund, prepared statement ...................................... 697

Murray, Hon. Patty, U.S. Senator from Washington, questions submitted

by ........................................................................................................................... 246

National:

AHEC Organization, prepared statement ...................................................... 609

Alliance for Eye and Vision Research and the Foundation Fighting Blindness, prepared statement ............................................................................. 597

Alliance to End Homelessness, prepared statement ...................................... 595

Alopecia Areata Foundation, prepared statement ......................................... 599

Association of Anorexia Nervosa and Associated Disorders, prepared

statement ....................................................................................................... 602

Association of Children’s Hospitals, prepared statement .............................. 603

Association of Developmental Disabilities Councils, prepared statement ... 606

Association of State Workforce Agencies, prepared statement ..................... 687

Center for Victims of Crime, prepared statement ......................................... 611

Coalition for Heart and Stroke Research, prepared statement .................... 613

Down Syndrome Society, prepared statement ............................................... 622

Federation of Community Broadcasters, prepared statement ...................... 698

Fuel Funds Network, prepared statement ..................................................... 614

Indian Child Welfare Association, prepared statement ................................ 616

Jewish Medical and Research Center, prepared statement .......................... 515

Latex Allergy Network, prepared statement .................................................. 620

Marfan Foundation, prepared statement ....................................................... 626

Medical Association, prepared statement ....................................................... 628

Military Family Association, Inc., prepared statement ................................. 432

Minority Public Broadcasting Consortia, prepared statement ..................... 700

MPS Society Inc., prepared statement ........................................................... 631

Multiple Sclerosis Society, prepared statement ............................................. 632

Neurofibromatosis Foundation, Inc., prepared statement ............................ 636

Organization for Rare Disorders, prepared statement .................................. 637

Psoriasis Foundation, prepared statement ..................................................... 641

Public Radio, prepared statement ................................................................... 701

Sleep Foundation, prepared statement ........................................................... 642

Task Force to End Sexual and Domestic Violence Against Women, prepared statement ............................................................................................ 668

Treasury Employees Union, prepared statement .......................................... 690

NephCure Foundation, prepared statement .......................................................... 645

New York University, prepared statement ............................................................ 646
Page

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Nowell, Jacqueline, director, Safety and Health, United Food and Commercial

Workers International Union .............................................................................. 189

Prepared statement .......................................................................................... 190

Nyeholt, James and Margaret, prepared statement ............................................. 649

O’Connor, Dr. Christina, prepared statement ....................................................... 650

Olden, Hon. Kenneth, Director, National Institute of Environmental Health

Sciences, National Institutes of Health, Department of Health and Human

Services, prepared statement .............................................................................. 353

Paige, Dr. Roderick R., Secretary of Education, Office of the Secretary, Department of Education ......................................................................................... 251

Prepared statement .......................................................................................... 262

Summary statement ......................................................................................... 255

Pancreatic Cancer Action Network, Inc., prepared statement ............................. 652

Penn, Dr. Audrey S., Acting Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Department of Health

and Human Services ............................................................................................ 293

Prepared statement .......................................................................................... 356

People for the Ethical Treatment of Animals, prepared statement .................... 653

Population Association of America and the Association of Population Centers,

prepared statement .............................................................................................. 656

Pulmonary Hypertension Association, prepared statement ................................. 659

Punnett, Dr. Laura, professor, Department of Work Environment, University

of Massachusetts Lowell ...................................................................................... 139

Prepared statement .......................................................................................... 141

Reid, Hon. Harry, U.S. Senator from Nevada:

Prepared statement .......................................................................................... 266

Questions submitted by ................................................................................. 63, 287

Research Society on Alcoholism, prepared statement .......................................... 661

Rhinehart, Lynn, American Federation of Labor-Congress of Industrial Organizations ................................................................................................................ 3

Prepared statement .......................................................................................... 22

Rotary International, prepared statement ............................................................ 663

Ruffin, John, Ph.D., Director, National Center on Minority Health and Health

Disparities, National Institutes of Health, Department of Health and

Human Services, prepared statement ................................................................ 359

Scleroderma Research Foundation, prepared statement ...................................... 667

Seminario, Peg, director, Department of Occupational Safety and Health,

AFL–CIO ............................................................................................................ 88, 197

Prepared statement .......................................................................................... 89

Sjogren’s Syndrome Foundation, prepared statement .......................................... 669

Skelly, Thomas P., Director, Budget Service, Department of Education ............ 251

Sparlin, Dean, Esq., Gibson, Dunn & Crutcher, LLP ........................................... 165

Prepared statement .......................................................................................... 167

Specter, Hon. Arlen, U.S. Senator from Pennsylvania:

Opening statements ......................................................... 1, 27, 65, 201, 251, 293

Questions submitted by ............................................................... 54, 229, 280, 394

Spiegel, Dr. Allen M., National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and

Human Services ................................................................................................... 293

Prepared statement .......................................................................................... 364

Stevens, Hon. Ted, U.S. Senator from Alaska:

Opening statement ........................................................................................... 30

Questions submitted by ........................................................................ 58, 245, 401

Straus, Stephen E., M.D., Director, National Center for Complementary and

Alternative Medicine, National Institutes of Health, Department of Health

and Human Services, prepared statement ......................................................... 362

Sudden Infant Death Syndrome Alliance, prepared statement ........................... 672

Tabak, Lawrence A., Director, National Institute of Dental and Craniofacial

Research, National Institutes of Health, Department of Health and Human

Services, prepared statement .............................................................................. 367

The Mended Hearts, Inc., prepared statement ..................................................... 590
Page

vi

Thompson, Hon. Tommy G., Secretary, Office of the Secretary, Department

of Health and Human Services ........................................................................... 27

Prepared statement .......................................................................................... 32

Summary statement ......................................................................................... 31

Trust for America’s Health, prepared statement .................................................. 674

U.S. Senators and House Members, copy of letter sent to ................................... 25

United:

Fresh Fruit & Vegetable Association, prepared statement ........................... 677

Tribes Technical College, prepared statement ............................................... 435

University of:

Cincinnati, prepared statement ....................................................................... 448

Medicine and Dentistry of New Jersey, prepared statement ........................ 678

Miami, Coral Gables, Florida, prepared statement ....................................... 682

Tulsa, prepared statement ............................................................................... 438

Vaitukaitis, Dr. Judith L., Director, National Center for Research Resources,

National Institutes of Health, Department of Health and Human Services,

prepared statement .............................................................................................. 371

Whitescarver, Jack, Ph.D., Acting Director, Office of AIDS Research, National

Institutes of Health, Department of Health and Human Services, prepared

statement .............................................................................................................. 374

Wood, Jerri, legislative chairman, Local 7800, Communication Workers of

America ................................................................................................................. 192

Prepared statement .......................................................................................... 194

Woodward, Joseph M., Associate Solicitor of Labor, Occupational Safety and

Health Administration, Department of Labor..................................................... 3, 68
(vii)

SUBJECT INDEX

ERGONOMICS

Page

Application of ergonomics, what are the tangible benefits to? ............................ 172

Approach ................................................................................................................... 120

Congress, questions posed by, answers to ............................................................. 130

Congressional Review Act to rescind ergonomics regulation, AHCA praises

use of ..................................................................................................................... 25

Considerations, additional ...................................................................................... 129

CRA, Department activities since .......................................................................... 71

Credentials and qualifications ................................................................................ 170

Data collection and reporting systems, the need for ............................................ 122

Dimensions of the problem ..................................................................................... 121

Dissent ...................................................................................................................... 122

Panel response to .............................................................................................. 134

Does ergonomics work? ........................................................................................... 171

Epidemiologic evidence since 1997 ......................................................................... 143

Epidemiology, summary of ...................................................................................... 147

Ergonomic:

Interventions, the effectiveness of ................................................................... 104

Programs are technically feasible and are cost-effective, actual industrial

experience shows that .................................................................................. 177

Sues in the health care workplace, addressing .............................................. 184

Standard, adequate scientific and clinical basis exists to support ............... 100

Standard, refutation of some common arguments against ........................... 106

Trends in applied .............................................................................................. 173

Why failed ......................................................................................................... 71

Evidence, patterns of ............................................................................................... 126

Exposure—response relationships .......................................................................... 145

Impetus ..................................................................................................................... 120

Industry misrepresentations about costs, history of ............................................. 180

Injuries, cost of ......................................................................................................... 181

Literature reviews ................................................................................................... 145

Musculoskeletal disorders:

Epidemiology in 1997, NIOSH review of ........................................................ 142

The importance of early recognition and appropriate treatment of ............. 101

And the workplace—low back and upper extremities ................................... 123

The toll of, on workers and the economy is great .......................................... 91

OSHA ergonomics standard:

National Academy of Sciences/Institute of Medicine report supports .......... 22

Needed to protect workers from musculoskeletal disorders ......................... 93

Panel:

Charge, composition, and approach ................................................................ 125

Composition ....................................................................................................... 120

Principles .................................................................................................................. 72

Psychosocial factors and MSDs .............................................................................. 146

Recommendations .................................................................................................... 128

Research agenda ...................................................................................................... 122

Scientific evidence in support of an ergonomics standard is extensive and

strong .................................................................................................................... 92

Timeline .................................................................................................................... 70

Truth, the first casualty of war is the .................................................................... 177

What’s next? ............................................................................................................. 73

Work factors and musculoskeletal disorders, relationship among ...................... 121

Work-related musculoskeletal disorders are the Nation’s leading job safety

problem ................................................................................................................. 90
Page

viii

Workplace interventions, the value of ................................................................... 121

DEPARTMENT OF EDUCATION

OFFICE OF THE SECRETARY

Achievement:

Creating a culture of ........................................................................................ 258

Gap, closing the ................................................................................................ 263

Additional committee questions ............................................................................. 280

American history instruction support .................................................................... 289

Annual testing, cost of ............................................................................................. 279

Campus crime .......................................................................................................... 275

Choices, empowering parents with ......................................................................... 264

Clery Act implementation ....................................................................................... 281

College:

Education, access to a ...................................................................................... 284

Persistence in .................................................................................................... 283

Population, growth in ....................................................................................... 283

Community Learning Centers, 21st Century ........................................................ 282

Debate reform and principles of reform, not budget ............................................. 260

Dropout problem, addressing the ........................................................................... 287

Education 302(b) congressional budget allocation ................................................ 254

Education budget:

Issues ................................................................................................................. 251

Strategic review of ............................................................................................ 253

Education change:

Guiding principles of ........................................................................................ 259

Principles of ...................................................................................................... 260

Elementary and secondary proposals, other key ................................................... 265

Elementary School Counseling Demonstration Program ..................................... 284

ESEA:

Reauthorization ................................................................................................ 259

Spending and 4th grade math achievement ................................................... 257

Reading achievement ................................................................................ 257

Excellence:

Education must be nationwide ........................................................................ 255

Requires change ................................................................................................ 255

Expanding flexibility and reducing bureaucracy .................................................. 264

Failing schools—cumulative effect of achievement gaps ...................................... 260

Federal:

ESEA investment and student achievement .................................................. 258

Role and school construction ........................................................................... 267

Fellowships, GAANN and Javits ............................................................................ 286

Funding:

Class-size reduction .......................................................................................... 290

For special education and IDEA reauthorization .......................................... 277

School construction ...................................................................................... 267, 269

Renovation ................................................................................................. 253

Special education .............................................................................................. 252

Higher education, unmet need and access to ........................................................ 282

Houston:

Independent school system .............................................................................. 259

School system reforms and public opinion ..................................................... 262

Impact aid construction ........................................................................................... 271

Leveraging Federal funds—school construction in Iowa ...................................... 270

Math and science budget support ........................................................................... 285

NAEP testing results—4th grade reading scores .................................................. 255

Pell Grant Program costs ........................................................................................ 289

Postsecondary education ......................................................................................... 265

President’s proposal and use of school construction funds ................................... 277

Reading performance, flat ....................................................................................... 256

Reform and results, budget increases to be tied to ............................................... 275

Reform, education funds for .................................................................................... 281

School renovation grants—guidance for implementation ..................................... 281

Shortages, special education teacher ..................................................................... 284

Tax cut package and education funding ................................................................ 253

Teacher:

Fund and class size reduction, flexible ........................................................... 268
Page

ix

Teacher—Continued

Retention and recruitment grants .................................................................. 288

Teaching:

American History Grant Program ................................................................... 290

Transition to ..................................................................................................... 288

Testing and accountability ...................................................................................... 279

Title I:

Allocations—use of updated data .................................................................... 291

Budget request .................................................................................................. 287

Hold-harmless ................................................................................................... 291

‘‘Shortfall’’ .......................................................................................................... 291

State Grants Program, Assistive Technology Act .......................................... 285

TRIO programs.................................................................................................... 283, 289

Vocational education programs support ................................................................ 286

Vouchers:

Private school .................................................................................................... 280

School choice ..................................................................................................... 274

Youth violence .......................................................................................................... 280

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

Additional committee questions ............................................................................. 393

Adolescents:

Factors influencing obesity in .......................................................................... 322

Reducing HIV and AIDS among ..................................................................... 301

Adult stem cell experiment ..................................................................................... 381

Aging, biology of ....................................................................................................... 326

AIDS:

Comprehensive research plan and budget ...................................................... 375

Research, Office of ............................................................................................ 349

Alcohol:

Is unique ........................................................................................................... 318

Research, advances in ...................................................................................... 319

Alcoholism, neuroscience holds the key to behaviors of ....................................... 319

Alzheimer’s disease:

Conquering ........................................................................................................ 324

Patients, improving daily living for ................................................................ 321

Research ............................................................................................................ 383

Autism research ....................................................................................................... 301

Basic science, beyond ............................................................................................... 320

Behavior ................................................................................................................... 342

Bioengineering, bioimaging, and bioinformatics ................................................... 372

Biomedical research infrastructure ........................................................................ 405

Bone biology and bone diseases .............................................................................. 333

Botanicals ................................................................................................................. 363

Budget summary, fiscal year 2002 ......................................................................... 318

Budgetary increases ................................................................................................ 415

CAM interventions, mechanisms of ....................................................................... 362

Canavan’s research .................................................................................................. 401

Cancer ....................................................................................................................... 363

Trends ................................................................................................................ 337

Capacity building programs, other ......................................................................... 361

Centers of Excellence Program ............................................................................... 361

Children:

Research in ........................................................................................................ 332

To grow, improving the environment for ........................................................ 301

Cholesterol guidelines, new .................................................................................... 397

Chronic:

Infectious diseases: Dental caries and periodontal diseases ......................... 369

Pain and temporomandibular disorders, new methods needed to treat ...... 370

Clinical Research Career Development programs ................................................ 400

Clinical:

Research: Taking basic discoveries into medical practice ............................. 298

Trials, including child mental disorder studies ............................................. 331

Congenital cardiovascular malformations ............................................................. 340

Diabetes .................................................................................................................... 365
Page

x

Diagnosis .................................................................................................................. 338

Disease:

And disability, reducing ................................................................................... 325

New preventive strategies against .................................................................. 372

Drug:

Abuse prevention, science-based principles for .............................................. 347

Problems, responding to ever-emerging new .................................................. 346

Embryonic stem cell potential ................................................................................ 382

End-of-life/palliative care research ......................................................................... 322

End-stage renal disease and polycystic kidney disease ........................................ 367

Environmental susceptibility genes, search for .................................................... 355

Ethical, legal, and social implications .................................................................... 311

External influences .................................................................................................. 342

Fundamental question, new technology to help answer a ................................... 300

Funding collaboration .............................................................................................. 408

Gene:

And the environment ....................................................................................... 354

Expression ......................................................................................................... 309

Generation of researchers, developing a new ........................................................ 313

Genetic:

And genomics .................................................................................................... 341

Research is key to understanding craniofacial disorders .............................. 369

Variability, exposure, and disease association ............................................... 355

Genome sequences of non-human species .............................................................. 308

Genomic:

And genetic medicine................................................................................... 297, 371

Science, centers of excellence in ...................................................................... 310

Global health:

Challenges in .................................................................................................... 335

Emerging infectious diseases ........................................................................... 314

Government Performance and Results Act ................... 318, 321, 343, 348, 353, 370

Grant submissions:

Quality of science in ......................................................................................... 415

Success rate for ................................................................................................. 415

Health:

And disease, understanding ............................................................................. 341

Disease and stroke, trans-agency conference .................................................

Disparities.......................................................................... 298, 307, 332, 364, 373

Education and communication ........................................................................ 353

Information dissemination ............................................................................... 361on

395

Hepatitis C and other chronic liver diseases ......................................................... 366

HIV infection, investigating the oral cavity’s contribution to defending the

body against .......................................................................................................... 370

HIV/AIDS ................................................................................................................. 314

Human:

Genetic variation .............................................................................................. 309

Genome sequence, finishing the ...................................................................... 308

Immune-mediated diseases ..................................................................................... 315

Inflammatory bowel disease and other digestive diseases ................................... 367

Information dissemination ...................................................................................... 416

Infrastructure and enabling technologies .............................................................. 298

Initiatives:

Fiscal year 2002 ................................................................................................ 336

New and expanded ........................................................................................... 322

Integrative medicine and research training .......................................................... 364

International collaborations by institutes ............................................................. 409

Investments, return on ............................................................................................ 398

Islet:

Inadequate supply of ........................................................................................ 384

Transplants in type 1 diabetes ........................................................................ 384

John Edward Porter Neuroscience Research Center ............................................ 331

Learning, behavioral interventions to improve ..................................................... 301

Loan Repayment Program ...................................................................................... 361

Low vision ................................................................................................................ 407

Mandate, broadening the ........................................................................................ 344

Mental:

And general medical disorders, co-occurring .................................................. 329
Page

xi

Mental—Continued

Disorder phenotypes, animal models can provide .......................................... 330

Disorders are enormously disabling ................................................................ 329

Illness research, molecular genetics tools benefit .......................................... 330

Meritorious research ................................................................................................ 400

Molecular targets: A new era in the discovery and development of preventive

and therapeutic agents for cancer ...................................................................... 338

Mood disorders, strategic research planning targets ............................................ 329

Muscle biology and muscle diseases ....................................................................... 333

National drug abuse treatment clinical trials network ........................................ 346

NCCAM success rate ............................................................................................... 406

NDRI expansion ....................................................................................................... 394

Neurological:

Diseases, progress and promise in .................................................................. 357

Disorders, the burden of .................................................................................. 356

Neuroscience portfolio sets stage for new treatments .......................................... 347

NIAID, overview of .................................................................................................. 313

NIBIB, new technologies in .................................................................................... 399

NIDA’S comprehensive portfolio ............................................................................. 345

NIH institutes and centers, leveraging resources with the ................................. 359

NINDS stroke strategic plan .................................................................................. 394

Nursing research, building the capacity to do ....................................................... 323

OD activities, other .................................................................................................. 350

Pancreatic cancer ..................................................................................................... 404

Pandemic, the exploding ......................................................................................... 374

Population morbidity and mortality rates ............................................................. 398

Practice at the community level, translating research findings into .................. 321

President’s request, amount of ............................................................................... 343

Prion:

NIH support of .................................................................................................. 404

Research ............................................................................................................ 404

Priority:

Basic science ..................................................................................................... 376

International research ...................................................................................... 376

Prevention research .......................................................................................... 375

Racial and ethnic minorities ............................................................................ 376

Treatment research .......................................................................................... 376

Vaccine research ............................................................................................... 375

Promise, mission of .................................................................................................. 312

Protein structure, function, and interaction .......................................................... 310

Public health and public safety approaches, blending .......................................... 348

Quality of life for all Americans, reducing oral health disparities to improve ... 368

Research:

Behavioral and social ....................................................................................... 326

Capacity ............................................................................................................. 373

Cataract ............................................................................................................. 352

Corneal disease ................................................................................................. 351

Creates new materials for replacing and restoring damaged tissues .......... 369

Directions, identifying productive new ........................................................... 312

Early detection .................................................................................................. 338

Endowment Program ........................................................................................ 361

Glaucoma ........................................................................................................... 352

Grant portfolio, an independent ...................................................................... 360

Initiatives, recent ............................................................................................. 306

Mission, role in the ........................................................................................... 316

Project grants .................................................................................................... 399

Retinal disease .................................................................................................. 351

Strabismus, amblyopia, and visual processing .............................................. 352

Training ............................................................................................................. 306

Training and career development ................................................................... 373

Retinal degenerative diseases ................................................................................. 407

Science:

Advances ........................................................................................................... 344

Leads our national discourse ........................................................................... 348

Sickle cell disease .................................................................................................... 340

SIDS, new collaborations to eliminate racial disparities in ................................. 300

Skin biology and skin diseases ............................................................................... 333

Stem cell ................................................................................................................... 400
Page

xii

Stem cell—Continued

Funding ............................................................................................................. 405

In vision research, use of ................................................................................. 385

Research ............................................................................................................ 384

The Office of:

Behavioral and Social Sciences Research ....................................................... 349

Disease Prevention ........................................................................................... 350

Research on Women’s Health .......................................................................... 349

Toxicity/carcinogenicity, assessment of .................................................................. 354

Treatments and prevention, promise for new ....................................................... 310

United States, the evolving epidemic in the .......................................................... 374

Urologic diseases ...................................................................................................... 367

Vaccine development ............................................................................................... 316

Variant ...................................................................................................................... 401

vCJD:

And prion infected beef .................................................................................... 404

On the rise? ....................................................................................................... 402

Research, role of NIH in .................................................................................. 402

Viral similarities ...................................................................................................... 403

Visual impairment and its rehabilitation .............................................................. 352

What is NINDS doing to move toward cures? ....................................................... 358

Women’s health ........................................................................................................ 302

OFFICE OF THE SECRETARY

27

Additional committee questions ............................................................................. 54

Alternative medicines .............................................................................................. 48

America’s children and families, increasing support for ...................................... 33

Budget proposal, President’s fiscal year 2002 ....................................................... 60

Center for Mental Health Services ......................................................................... 60

Child care................................................................................................................. 43, 46

Development block grant ................................................................................. 57

Child support reform ............................................................................................... 52

Children with mental retardation, special health needs of .................................. 58

Chronic disease tracking system ............................................................................ 63

Community:

Attendant services and supports ..................................................................... 62

Health centers .................................................................................................. 56, 61

Disease control prevention, centers for .................................................................. 39

Faith-based initiatives ............................................................................................ 48, 54

Family planning ....................................................................................................... 51

Federal mental health funding ............................................................................... 59

Foster care ............................................................................................................... 45, 47

Head Start ................................................................................................................ 57

Health care ............................................................................................................... 44

Infrastructure and reforming management, investing in ..................................... 36

Medicaid program .................................................................................................... 50

Medicare and expanding access to quality health care, improving ..................... 35

National Health Service Corps ............................................................................... 61

Nursing:

Home initiative ................................................................................................. 53

Shortage............................................................................................................ 42, 46

Nutrition programs .................................................................................................. 50

Obesity rates ............................................................................................................ 49

Real Choice Systems Change grants ...................................................................... 62

Ryan White programs .............................................................................................. 57

SCHIP ....................................................................................................................... 44

Scientific and health care quality research, enhancing ........................................ 34

Stem cell research .................................................................................................... 40

Strong and healthy America, working together to build a ................................... 39

Tobacco, regulation of, by FDA ............................................................................... 41

Advertisements ................................................................................................. 41

Youth violence ......................................................................................................... 47, 57

DEPARTMENT OF LABOR

OFFICE OF THE SECRETARY

Additional committee questions ............................................................................. 229
Page

xiii

Advance appropriation ............................................................................................ 208

Asbestos, exposure of miners to, in Libby, Montana ............................................ 246

Bureau of International Labor Affairs (ILAB) ...................................................... 240

Caregivers, shortage of ............................................................................................ 248

Companionship services .......................................................................................... 229

Coordination, one-stop ............................................................................................. 233

Disability employment policy .................................................................................. 207

Employment and training programs ...................................................................... 206

Energy Employees Occupational Illness Compensation Program Act

(EEOICPA) .............................................................................................. 208, 238, 247

ERGO II .................................................................................................................... 244

Fair Labor Standards Act (FLSA) .......................................................................... 242

Federal Employees’ Compensation Act surcharge ................................................ 209

Funding level, fiscal year 2002 ............................................................................... 234

Government Performance and Results Act ............................................................ 209

Grant accountability ................................................................................................ 209

Harwood grants ....................................................................................................... 230

Health care professionals, immigration of ............................................................. 249

Information technology ............................................................................................ 208

Cross-cut budget ............................................................................................... 231

Injuries, underreporting of ...................................................................................... 243

International labor affairs ...................................................................................... 208

Labor statistics ........................................................................................................ 208

Long-term care givers, legislation for .................................................................... 249

Mass layoffs .............................................................................................................. 246

Migrant and Seasonal Farmworker Housing Program ........................................ 249

Office of the 21st Century Workforce ..................................................................... 230

OSHA:

Enforcement budget ......................................................................................... 244

Ergonomists ...................................................................................................... 243

MSHA and ESA staff reductions ..................................................................... 231

Standards .......................................................................................................... 244

Pension and Welfare Benefits Administration ...................................................... 241

Pension distributions, lump sum ............................................................................ 242

Personal protective equipment ............................................................................... 241

Staffing shortages .................................................................................................... 240

The Treasury, funds reverting to ........................................................................... 235

Trade Adjustment Assistance (TAA)/North American Free Trade AgreementTransitional Adjustment Assistance (NAFTA-TAA) ......................................... 209

Training needs, State flexibility for ....................................................................... 235

Transitional Living Program .................................................................................. 230

Unemployment insurance ....................................................................................... 208

Unspent funds listed by State and by grant ......................................................... 235

Veterans’ Employment and Training Service ........................................................ 208

WIA budget request reductions .............................................................................. 245

Disparity in ....................................................................................................... 241

Women’s Bureau equal pay ..................................................................................... 247

Worker layoffs .......................................................................................................... 233

Worker protection/compliance assistance .............................................................. 207

Workforce programs, cuts in ................................................................................... 232

Youth programs ....................................................................................................... 248

Additional funding ............................................................................................ 234

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