U.S. GOVERNMENT PRINTING OFFICE

67–153 CC WASHINGTON : 2000

AGENT ORANGE: STATUS OF THE AIR FORCE

RANCH HAND STUDY

HEARING

BEFORE THE

SUBCOMMITTEE ON NATIONAL SECURITY,

VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

MARCH 15, 2000

Serial No. 106–163

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

LISA SMITH ARAFUNE, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

MARK E. SOUDER, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH-HAGE, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

ROBERT NEWMAN, Professional Staff Member

JASON CHUNG, Clerk

DAVID RAPALLO, Minority Counsel

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C O N T E N T S

Page

Hearing held on March 15, 2000 ............................................................................ 1

Statement of:

Albanese, Dr. Richard, Senior Medical Research Officer, U.S. Air Force,

former Ranch Hand Principal Investigator; Dr. Linda Schwartz, associate research scientist, Yale University School of Nursing, consultant,

Veterans Health Care; and Dr. Ronald Trewyn, dean of graduate school

and vice provost of research, Kansas State University, former member

Ranch Hand Advisory Committee ............................................................... 92

Chan, Kwai-Cheung, Director, Special Studies and Evaluations, National

Security and International Affairs Division, General Accounting Office,

accompanied by Dr. John Oppenheim, Assistant Director, National Security International Affairs Division, General Accounting Office; and

Dr. Weihsueh Chiu, Project Manager, Agent Orange Study, National

Security and International Affairs Division, General Accounting Office . 7

Michalek, Dr. Joel, Senior Principal Investigator, Air Force Health Study

on Exposure to Herbicides, Department of Defense; Robert J. Epley,

Director, Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, accompanied by Dr. Susan

Mather, Chief Public Health and Environmental Hazards Officer, Department of Veterans Affairs; Ronald Coene, Executive Secretary,

Ranch Hand Advisory Committee, Food and Drug Administration; and

Dr. David Butler, Senior Program Officer, Veterans and Agent Orange

Reports, Institute of Medicine, National Academy of Sciences ................. 39

Letters, statements, et cetera, submitted for the record by:

Albanese, Dr. Richard, Senior Medical Research Officer, U.S. Air Force,

former Ranch Hand Principal Investigator, prepared statement of ......... 95

Butler, Dr. David, Senior Program Officer, Veterans and Agent Orange

Reports, Institute of Medicine, National Academy of Sciences, prepared

statement of ................................................................................................... 70

Chan, Kwai-Cheung, Director, Special Studies and Evaluations, National

Security and International Affairs Division, General Accounting Office,

prepared statement of ................................................................................... 10

Coene, Ronald, Executive Secretary, Ranch Hand Advisory Committee,

Food and Drug Administration, prepared statement of ............................ 60

Epley, Robert J., Director, Compensation and Pension Service, Veterans

Benefits Administration, Department of Veterans Affairs, prepared

statement of ................................................................................................... 47

Evans, Hon. Lane, a Representative in Congress from the State of Illinois:

Letters dated January 21 and March 9, 2000 ........................................ 30

Prepared statement of ............................................................................... 26

Michalek, Dr. Joel, Senior Principal Investigator, Air Force Health Study

on Exposure to Herbicides, Department of Defense, prepared statement

of ..................................................................................................................... 42

Schwartz, Dr. Linda, associate research scientist, Yale University School

of Nursing, consultant, Veterans Health Care, prepared statement of .... 100

Shays, Hon. Christopher, a Representative in Congress from the State

of Connecticut, prepared statement of ........................................................ 3

Trewyn, Dr. Ronald, dean of graduate school and vice provost of research,

Kansas State University, former member Ranch Hand Advisory Committee, prepared statement of ...................................................................... 112

(1)

AGENT ORANGE: STATUS OF THE AIR FORCE

RANCH HAND STUDY

WEDNESDAY, MARCH 15, 2000

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS

AFFAIRS, AND INTERNATIONAL RELATIONS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:05 a.m., in room

2247, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Lee, and Sanders.

Also present: Representative Evans.

Staff present: Lawrence J. Halloran, staff director and counsel;

Robert Newman, professional staff member; Jason M. Chung, clerk;

David Rapallo, minority counsel; Ellen Rayner, minority chief

clerk; and Earley Green, minority assistant clerk.

Mr. SHAYS. Good morning, I would like to call this hearing to

order.

This week saw the first visit to Vietnam by a U.S. Secretary of

Defense since the war ended. While there, Secretary Cohen cited

our ‘‘absolute, sacred obligation’’ to persist in the search for those

still missing in action, those long remembered but too long unaccounted for.

The same obligation to those who fought brings us here this

morning. The search for long latent illnesses associated with exposure to herbicides in Vietnam demands the same persistence, the

same integrity, the same willingness to confront hard truths. Eighteen years ago, the Air Force began a 25-year, $140 million

research program to assess the relative health of 1,300 ranch

hands, air and ground crew members who handled and sprayed

Agent Orange and other defoliants in Vietnam. The Ranch Hand

Study was designed to generate significant scientific data and analysis to be used by the Department of Veterans Affairs [VA], and

others in making health care and compensation decisions regarding

Vietnam veterans.

But according to a recent study by the General Accounting Office

[GAO], requested by our colleague, Representative Lane Evans

from Illinois, ranking member on the House Veterans’ Affairs Committee, Ranch Hand has been slow to publish findings, unwilling

to share data, inconsistent in conveying design limitations, and resistant to congressionally mandated participation by independent

parties.

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Controversial from the outset, the Ranch Hand study has been

consistently criticized for both scientific and administrative shortcomings. Many believe Ranch Hand has so far failed to fulfill its

promise as the pivotal longitudinal study of herbicide toxicity.

Some conclude it never will. Others believe this research was designed to fail, or manipulated to avoid controversial findings.

Vigilance and independence are needed to resist institutional biases and sustain the pace and rigor of long term research. Today,

we ask if the Ranch Hand study meets that test.

It has been said history teaches us the mistakes we are about to

make. The history of the Ranch Hand study has much to teach

about the mistakes that should not be repeated as the research

proceeds, and similar studies are designed for gulf war veterans,

anthrax vaccine recipients, and the veterans of future toxic conflicts.

Our witnesses this morning bring a great deal of experience, expertise, and passion to this important discussion. We look forward

to their testimony. And we welcome everyone who is here today.

[The prepared statement of Hon. Christopher Shays follows:]

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Mr. SHAYS. At this time, I would like to recognize Mr. Sanders,

who has really been at the cutting edge of this issue and gulf war

illnesses, as well as anthrax. Mr. Sanders.

Mr. SANDERS. Thank you very much, Mr. Chairman.

Let me begin by applauding the chairman for holding this hearing and for saying that he and I and others have been working for

a number of years on gulf war illness and on other veteran issues.

And for people who think that we are going to disappear and go

away and give up the fight, they are wrong. We are going to stay

with it, no matter how long it takes to get justice for American veterans.

Agent Orange, as I think everybody knows, is one of the most

toxic chemical compounds that has ever been invented. According

to Jacqueline Veret of the FDA, it is ‘‘100,000 times more potent

than thalidomide as a cause of birth defects in some species.’’ There are many veterans, there are many Members of Congress,

there are many Americans who believe the Department of Defense

and the Veterans Administration have been less than candid about

the health effects that Agent Orange has had on them and on veterans’ children. While the Government has acknowledged that

some illnesses the Vietnam veterans developed are associated with

Agent Orange exposure, and that these vets can receive disability

benefits, many veterans believe that the health problems associated with Agent Orange are far more serious and widespread than

the Government has acknowledged up to this point.

Also, many veterans believe that the VA and the DOD have been

less than effective in developing an outreach program which informs veterans about what benefits they might be entitled to from

VA relating to Agent Orange exposure and how they might access

those benefits.

In other words, there are two issues. One is the scientific study

to determine what health problems are associated with Agent Orange exposure. But the next issue, equally important, is that once

you have developed those conclusions, we have the moral obligation

to reach out to the veterans and tell them that if they are suffering

from this or that disease, they are entitled to benefits.

And I believe that the record that the VA has established in that

regard, of reaching out to veterans, of making them aware of what

they are entitled to, has been very, very poor.

Some of you may have noticed recently there was an article in

the papers throughout this country where the Government of Vietnam has indicated that approximately 1 million people in Vietnam

have been hit with health effects as a result of exposure to Agent

Orange. And that should wake us up, in terms of the damage that

was done to American soldiers who were over there.

The Ranch Hand study, about which the subcommittee will hear

today, was supposed to answer many of the questions and concerns

that veterans and those of us who support veterans have about the

health effects of Agent Orange. This epidemiological study, which

was begun by the Air Force in 1982, has been criticized by many

years by scientists, Members of Congress, and the veterans community.

So far the study has cost some $100 million, an astronomical

sum of money. And while the study looked at the health effects of

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Agent Orange on Air Force personnel who sprayed the herbicide,

it will not answer the questions about the health effects of Agent

Orange on soldiers on the ground in Vietnam who were exposed to

Agent Orange differently, including through the ingestion of it in

food, swimming in it in the water, or drinking.

So we are not quite convinced that even that those people, who

were most exposed to Agent Orange have been fully studied. It is

beyond my comprehension that with all the resources of the U.S.

Government, we have not been able to track down those people

who are most exposed and take an objective look at the health

problems that they have suffered.

I would point out that in 1984 a lawsuit was settled, and that

it was a very controversial settlement, between Vietnam veterans

and the wartime manufacturers of Agent Orange, Dow Chemical,

Monsanto, Uniroyal, Diamond Shamrock, et al. What was interesting about that settlement, as many of you know, is that over

200,000 veterans received compensation from the chemical companies for harm resulting from Agent Orange exposure. Meanwhile,

and this is an important point, to date according to the VA’s own

figures only about 7,500 veterans have received service-connected

disability compensation from the U.S. Government.

While we acknowledge that the standards were different, I think

it should give us some pause for thought as to how 200,000 veterans could get some compensation from the chemical companies, and

after all of these years only 7,500 veterans have gotten disability

benefits from the Government.

Mr. Chairman, let me conclude by once again thanking you. I

look forward to hearing the testimony of our witnesses.

Mr. SHAYS. I thank the gentleman very much.

At this time, I would ask if Lee Terry from Nebraska would have

any comments he would like to make?

Mr. TERRY. No, thank you.

Mr. SHAYS. Let me take care of some housekeeping first, and ask

unanimous consent that all members of the subcommittee be permitted to place an opening statement in the record and the record

remain open for 3 days for that purpose. Without objection, so ordered.

I ask further unanimous consent that all witnesses be permitted

to include their written statements in the record. Without objection, so ordered.

I would ask unanimous consent to insert a statement from James

G. Zumwalt, son of the late Admiral Elmo Zumwalt, who long advocated Agent Orange research. He has eight points to make, and we

will insert that in the record. We might share some of it later

today. Without objection, so ordered.

I will recognize our first panel. It is wonderful to have you gentlemen here. We have Kwai Chan, Director, Special Studies and

Evaluations Group, General Accounting Office; accompanied by Mr.

John Oppenheim, Assistant Director, National Security International Affairs Division, General Accounting Office; and Dr.

Weisueh Chiu, Project Manager, Agent Orange Study, National Security International Affairs Division from the same office.

Gentleman, I would ask you to rise to swear you in, as we always

do.

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[Witnesses sworn.]

Mr. SHAYS. I would like the record to note that all three of our

witnesses have responded in the affirmative.

It is my understanding, Mr. Chan, that you will have the testimony and that you will be assisted by your able colleagues in responding to questions. Thank you.

STATEMENTS OF KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL

STUDIES AND EVALUATIONS, NATIONAL SECURITY AND

INTERNATIONAL AFFAIRS DIVISION, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY DR. JOHN OPPENHEIM, ASSISTANT DIRECTOR, NATIONAL SECURITY INTERNATIONAL

AFFAIRS DIVISION, GENERAL ACCOUNTING OFFICE; AND

DR. WEIHSUEH CHIU, PROJECT MANAGER, AGENT ORANGE

STUDY, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS

DIVISION, GENERAL ACCOUNTING OFFICE

Mr. CHAN. Thank you. Mr. Chairman, members of the subcommittee, it is my pleasure to be here today to discuss the findings of our report examining the Air Force’s ongoing Ranch Hand

study. This study is one of the most expensive and in depth studies

of the long-term health of a small group of Vietnam veterans. Many

have described the Ranch Hand study as the definitive health

study of Vietnam veterans exposed to herbicides such as Agent Orange.

Before I discuss our findings, let me first provide some background and context surrounding this study. During the Vietnam

war, the United States sprayed millions of gallons of herbicide, including Agent Orange, over Vietnam. In the late 1970’s, concerns

began to emerge over the long-term health problems of the veterans. Although they could have been exposed to many potential hazards, including herbicides, pesticides and infectious diseases, attention focused on herbicides. Several herbicides, including Agent Orange, contain the chemical dioxin. This chemical is known to cause

a variety of adverse health effects in animals, but its effects in humans remain controversial.

The Ranch Hand study follows the health and mortality of the

so-called Ranch Hands, the almost 1,300 Air Force personnel who

sprayed herbicide from the air in Vietnam. The 25-year study

began in 1982 and is scheduled to end in fiscal year 2006. It costs

over $100 million in then-year dollars to date, and it’s projected to

cost a total of $140 million by its conclusion.

Since its inception, the Ranch Hand study has been very controversial. Initially, many reviewers expressed concern that the

public would not consider this study credible. This was because the

Air Force, which conducted the spraying of herbicides in Vietnam,

was also given the responsibility to conduct the study. These concerns about the appearance of conflict of interest led to the inclusion of several safeguards intended to ensure scientific rigor and

objectivity. Among these measures was the establishment of an advisory committee of outside experts who were responsible for providing independent scientific review.

The Ranch Hand study is one of the few ongoing studies of the

health effects of herbicides in human populations. This is of particular importance with regards to the process for determining

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whether Vietnam veterans can receive disability compensation for

health conditions associated with herbicide exposure. Because,

when making compensation decisions, the Department of Veterans

Affairs places primary importance on evidence of adverse health

from human studies, not on evidence from animal or laboratory

studies.

Let me now discuss our key findings. First, though there were

high expectations that the Ranch Hand study would help resolve

health questions surrounding herbicide exposure, we found that the

study has had limited impact on veterans compensation decisions.

The most significant impact of the Ranch Hand study so far has

been on a decision in 1996 to provide compensation to Vietnam veterans’ children born with the birth defect spina bifida. The study

has not contributed either positively or negatively to decisions to

compensate for any other diseases.

Currently, the Department of Veterans Affairs has recognized a

total of 10 diseases, including spina bifida, for which Vietnam veterans can receive compensation.

The study has also led to increased discussion and further study

of the association between herbicide exposure and diabetes. This

was first reported by the Ranch Hand study in 1991, but currently

Vietnam veterans with diabetes are not eligible for compensation.

Let me turn to the implementation of the study. Although the

Air Force has conducted many aspects of the study vigorously, we

found several past and ongoing problems. Though many of these

problems have been resolved, they have led critics to raise questions about the openness and credibility of the study. The problems

we found are as follows.

First, delays have occurred in the dissemination of some important study results. For example, although the Ranch Hand study

has reported its results periodically in official Air Force reports

starting in 1983, publications of the study’s health findings in peerreviewed scientific journals did not begin until 1990.

Also, a key update to the study findings on reproductive outcomes and birth defects was delayed for 8 years and not released

until 1992. This was because the Air Force conducted additional

data verification and analysis without releasing any interim information. We found that the degree of verification was highly unusual and virtually unprecedented for a study of its size.

Second, public access to data remains limited. Currently, the

public can only access the 1987 physical examination data which

was released in 1995. Data from 1982, 1985, 1992, and 1997 have

not been released.

We recommended in our report that the Air Force establish and

publicize a timetable for the release of all study data and release

the data through a medium that is easily accessible to the general

public. The Air Force concurred with our recommendation. They

have since posed a timetable for the release of study data on their

website. In addition, they are investigating ways to release the

data in a more accessible format.

Third, communication of key study limitations by the Air Force

has been inadequate. The study has difficulty detecting increased

risk of rare diseases, including many forms of cancer. This is because of the relatively small size of the Ranch Hand population.

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Furthermore, the study’s findings cannot be generalized to all

Vietnam veterans. This is because the Ranch Hands and ground

troops were exposed to different levels of herbicide in Vietnam in

different ways. For instance, while Ranch Hand appear to have

been exposed to herbicide primarily through skin contact, ground

troops report exposure through contaminated food and water, as

well as contaminated clothing worn for extended periods of time.

Little is known about the potential impact of these differences.

Despite these limitations, early study press releases and executive summaries contained language that may have been misinterpreted to mean that the study showed herbicide were safe. More

recent press releases and executive summaries still do not clearly

communicate the study limitations to the public.

We recommended in our report that the Air Force include more

information on the study’s limitations in its press releases and executive summary. The Air Force concurred with our recommendation.

Fourth, in the early years of the study, two measures intended

to ensure that it was conducted independently and without appearance of bias were not carried out as planned. One of these measures, specified in the study’s protocol, was that the Air Force scientists in charge of conducting the study have primary responsibility over the scientific aspects of the study. However, in 1984 and

1985 the Air Force management and the White House tried to direct certain aspects of the Air Force scientists’ research.

In addition, the protocol specified that the study’s advisory committee include scientists nominated by veterans organizations.

However, the committee did not include veterans’ representatives

until 1989.

Finally, the advisory committee’s outreach to veterans is still an

issue. Better notification of committee meetings and vacancies

would help ensure that veterans groups perceive the committee as

fulfilling its role as an independent and unbiased oversight body.

The Food and Drug Administration concurred with our recommendation and stated that it has begun to work to ensure that

veterans organizations are notified of the committee’s activities in

a timely manner.

Mr. Chairman, this concludes my statement. Thank you.

[The prepared statement of Mr. Chan follows:]

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Mr. SHAYS. Mr. Chan, thank you.

At this time, I would ask Lee Terry if he has any questions.

Mr. TERRY. Thank you, Mr. Chairman.

I want you to expand on the third point of the credibility issues,

which was the limitations of the study. And the reason I want to

focus on that is because obviously this is an oversight committee.

We need to make informed opinions as to the credibility of the

study. And obviously, if the limitations are such that the credibility

is questioned, then I think we have to ask the question should we

continue.

So let us go back to the study and the limitations. You raised a

couple of points, but I would appreciate it if you would go over

those limitations to the Ranch Hand study and discuss them in a

little bit more detail and then I am going to ask some of the followup questions.

Mr. CHAN. We raised two points in terms of the—one is that of

the sample size and the second is the representativeness of the

Ranch Hands themselves. Let me talk about the sample size first.

Basically, the Ranch Hands consist of about 1,300 people, and

that’s all you have. You are limited by this small population.

Mr. TERRY. And who are those folks?

Mr. CHAN. They are Air Force pilots and ground crews where

they handle and sprayed the herbicides in Vietnam. The majority

of the spraying was done by this group of people. So in the early

stage, it was believed that this is a likely group of people who

might be exposed to the herbicide in the greatest quantity-wise, in

terms of exposure. The opportunity for exposure is much greater.

That is the belief they have.

But the sample size itself, basically what they did is they picked

the entire population of the Ranch Hands. And then, because it

was a study looking for Agent Orange, the effect of Agent Orange,

they picked the control group in various sizes as a ratio of one to

five to as many, so that they can replace those people. So currently

we have about 1,200 Ranch Hands versus about 1,800 of the control size for comparison.

These people were also in Vietnam doing—in the war, but they

were not supposedly exposed to Agent Orange. So the control group

is not really sort of like the Vietnam-era veterans who did not go

to Vietnam who were never exposed to anything.

Let me clarify that point right away. That’s how the comparison

is being done.

Mr. TERRY. Is there difficulty, from a scientific point of view, of

that being a credible control group for a scientific study?

Mr. CHAN. Let me give you my own opinion then, since we did

not address that in our report. In a way, you would love to have

three groups. One is those supposedly exposed to the Agent Orange, those who were there and supposedly have not been exposed,

and those who never went. Because that one actually would not

have any exposure to pesticide, to drinking the water, to taking

showers, to eating food and all those things that possibly could affect them, as well.

But the intent of the study is really to look for the affect of Agent

Orange, not on anything else. This is not a general health study,

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per se. So therefore, the third group was not included in that

study. That’s the first point.

Now when you have a comparison of 1,300 as the treatment

group, it’s statistically extraordinary to detect any kind of rare disease where let’s say it happens 1 out of 100,000 subjects, once in

100,000 and so on. Because statistically, out of these 1,300, it’s

very difficult to find these rare diseases, as we stated.

So as a result of that, since you cannot expand the size of this

group like an accordion, it’s difficult to have rare disease showing

up for comparison purposes because of the sample size. I mean, we

can go through a statistical way to analyze this, but clearly the

larger the sample size, the more likely you would find people with

those rare diseases. So that’s one problem with it.

The second problem is really that of representativeness. I think

in our statement we did say that this is solely represented by the

Air Force personnel. They are not the people who were on the

ground, such as the Marines, exposed to the spray at the time

when they’re out in the open as the spraying is being done, or

maybe exposed to the dioxin in a different manner than this. There

are different medium by which they may have been exposed.

So those are two major problems that we note.

Mr. TERRY. Can you help me work through the latter part, because I am having difficulty understanding. The representatives in

this group are just Air Force. You said others that may have been

exposed, Marines, are not part of the representative group?

Mr. CHAN. That’s true.

Mr. TERRY. But talking about the credibility of the study, whether it is scientifically based, explain to me how that may create

some issues of its credibility? Do you understand what I am saying? Just because some of the Marines were excluded, to me it is

not clicking why I should be concerned.

Mr. CHAN. It is really the medium of exposure. One clearly is the

following, I think, to think of logically. The spraying is done

through an aircraft so therefore, the handling of the dioxin of itself,

the herbicide. The other way is the soldier may have been exposed

while the spraying is going on by our own people. And water could

be contaminated where they may be drinking from it or taking

showers and so on and intake of food, and so on.

So what I’m saying as well as the possibility of the soldiers, particularly some of them told us they were out there in the jungles

for a long period of time where their clothing may be contaminated

and they couldn’t wash, unlike the pilots. They can finish spraying,

go back to their place, and then take a shower and have clean

clothing and so on. So there are different ways that you might be

exposed to the herbicide. That’s what we’re saying.

Mr. TERRY. So in this representative group, has the Air Force at

least identified the types of exposure that the sample size, the

group would have, whether it has been on clothes, from the ground,

water, drinking? Have they gone through the steps that you just

laid out?

Mr. CHIU. They have investigated, through surveys, different

ways in which the ground crew and the pilots were exposed. And

they were able to correlate that with measurements of dioxin in

those people’s blood. They found that most of the exposure from the

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Ranch Hands was through handling, bare skin contact, being

sprayed in the face when a valve was opened.

I guess my feeling is that the problem with credibility is more

in the communication of those limitations not necessarily the fact

that they exist. Because all studies will have limitations. Just making sure that you have a balanced communication of what the

study can tell you and what it can’t tell you. If for instance, we did

find some adverse health effect, then you need to make clear

whether the finding is more or less representative of other veterans. Especially of negative results. If they don’t find anything, then

there are limitations as to what that says. That doesn’t necessarily

mean that something isn’t happening in other veterans.

Mr. TERRY. And that is a great point, and that is ultimately the

goal of this study. So my question to you is based on the sample

size and the representatives in this group. Can we scientifically

make conclusions that we can communicate the details that you

just stated, Doctor? Or do we question whether we can credibly

communicate specifics to various veterans groups or types of representatives that are involved?

Mr. CHIU. I think it is possible to effectively communicate the

study’s findings and its limitations.

Mr. TERRY. Well, can we rely on those? Reliably? We can communicate anything. It doesn’t have to be reliable, as I’m learning in

my first 13 months in Congress.

Mr. OPPENHEIM. Mr. Terry, part of the problem, too, is in the

early reports that came out of the study. There are some statements in there that, as Mr. Chan mentioned, had the potential to

be misinterpreted. Terms such as reassuring were used in one report when no adverse health effects were found.

And I think that gets to the communication issue. The limitations weren’t communicated to the public in particular. I think the

scientific community recognized the limitations.

Mr. TERRY. And that goes to another issue of how people are

going to perceive the study and whether they believe it. That is the

next phase, I think, for us. But right now, we have to determine

if we find it to be a credible study.

Thank you, Mr. Chairman.

Mr. SHAYS. I thank the gentleman.

Mr. Sanders, you have the floor for 10 minutes.

Mr. SANDERS. Thank you, Mr. Chairman.

Let me begin by asking the panelists, I think most lay people,

most citizens, would say spending $100 million to study 1,300 people, and then coming up with the conclusion that the study has not

contributed either positively or negatively to the decisions to compensate for any other diseases, that is a hell of a lot of money to

be spent. How did they manage to spend so much money with so

little results, Mr. Chan?

Mr. CHAN. First of all, it’s a 25 year longitudinal study. So if

each year you spend an average of a few million dollars, it adds

up. And also, the actual physical examination of individuals was

extraordinarily detailed and very complete, and it costs money to

do that.

Mr. SANDERS. I appreciate that, but $100 million. Do you think

that that is—that sounds to me like it is quite inflated. It seems

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to me you could do a heart transplant for each of these people for

probably less money.

Mr. CHAN. $100 million averages what, about $5 million a year?

Mr. SHAYS. $5.6 million each year.

Mr. CHAN. And these are in then-year dollars, let me say that,

too. It’s a very detailed scientific endeavor and we are quite impressed with what they’ve done. But you’re right, also, it’s very expensive but they expected up front that it would cost this amount

of money.

Mr. SANDERS. Let me just switch gears and pick up on a point

that Mr. Terry was making, and tell me what I am missing here.

Common sense would suggest that those people who were most exposed to Agent Orange might suffer the most serious consequences.

That is what common sense would suggest.

We know that there were groups of soldiers who were really in

the midst of this thing, who were in the areas that were sprayed

for week after week, wearing the same clothes, drinking water. I

talked to guys in Vermont, they were drinking the water from the

rivers. They were eating food in the area. They were really living

in this stuff.

How did the Department of Defense manage not to take a hard

look at those people? Would not common sense have suggested let

us look at those people who were most exposed and see the health

impact that that exposure might have had on them. What is wrong

with that approach?

Mr. CHAN. I believe they did consider the other possible candidates for this study and they ultimately dismissed them. I might

add that as far back as 1979 GAO issued a report that basically

said that the United States ground troops in South Vietnam were

an area sprayed with herbicide Orange where we found that Marines to units in sprayed areas can be identified.

Mr. SANDERS. Can be?

Mr. CHAN. Yes, but the Army personnel in the sprayed areas

cannot be identified because Army records are incomplete. But 10

of 13 major Army units reviewed, report having Agent Orange in

their area of operation. So we do have some ideas of those exposed

from our previous studies that we have done, back in 1979. But

they did consider and they found that this is the most credible

group to study.

Mr. SANDERS. What do you think? Why would we not look at

those folks who were most exposed and just, I would be curious to

see. I mean, we hear anecdotally what people tell us, my child was

born with birth defects, this one died of cancer. That is anecdotal.

Why was it so difficult, if we are prepared to spend so much

money, why was it so hard to get better information on the epidemiology of those people most exposed, in your judgment?

Mr. OPPENHEIM. Mr. Sanders, when they started planning the

study back in the late 1970’s, I think there was the belief that this

Ranch Hand population was a heavily exposed population. Second,

I think there was some logistical concerns. One issue was that the

Ranch Hand group was a very defined population and it was a very

reachable population. So it was an easy study to—not an easy

study, but it was a study which could be developed without too

much difficulty and you could reach that population.

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Mr. SANDERS. I appreciate that and that is not unreasonable. But

tell me your views if somebody would argue that the life experiences and the type of exposure of somebody on the ground, who

was wearing the same clothing week after week, was swimming in

this stuff, is a different type of exposure. I am not opposed to looking at a group of Air Force people, but it seems to me to be somewhat incorrect to ignore those who were most exposed.

What am I missing in that analysis?

Mr. OPPENHEIM. I think that the other piece of it was that when

the Ranch Hand study was started, there was an understanding

that there would be other studies conducted at the same time.

Mr. SANDERS. Has that happened?

Mr. OPPENHEIM. Which may have covered the ground troops.

Mr. SANDERS. Has that happened?

Mr. OPPENHEIM. There’s been some to a limited extent. There’s

a Chemical Corps study that the VA is conducting, but it’s much

smaller and a much less in-depth study, I would say, than the

Ranch Hand study.

Mr. SANDERS. Is there any study being done right now involving

the health of those people who were most exposed to Agent Orange,

to your knowledge?

Mr. OPPENHEIM. I think this Chemical Corps population was another population believed to be heavily exposed, so that’s one study.

Mr. SANDERS. What are the results? Do we have any published

results on that?

Mr. OPPENHEIM. Help me out a little bit here, Weihsueh.

Mr. CHIU. Not to my knowledge.

Mr. SANDERS. So what kind of study is it, that we do not have

any results. The war did not end yesterday, we are a few years

down the line.

Mr. CHIU. The Chemical Corps study, Mr. Sanders, was initiated

after the National Academy of Sciences recommended that such a

study be done in 1993. In the 1980’s, there were several other studies done, one of which was the Vietnam Experience study, which

studied—basically compared people who went to Vietnam to people

who didn’t go to Vietnam. There was an attempt to conduct a study

relating to exposure to Agent Orange, but the CDC decided, after

conducting a pilot study, that they couldn’t develop a methodology

for exposure assessment. There was some hearings in the late

1980’s on that study.

Mr. SANDERS. Mr. Chairman, I would just say, and I am going

to get to another question in a moment, that after so many years

it really seems to me that the kind of information that we would

like is sorely lacking. We have spent a hell of a lot of money, a lot

of years have gone by, and I think that we do not have the kind

of information that we need.

Let me ask our panelists one other question. Mr. Chan, your report indicates that the VA asked the National Academy of Sciences

to evaluate the scientific literature on the association between exposure to herbicides and adult onset diabetes. Based on your review, what do you think the likely result of that review be? Will

diabetes be one of the diseases listed as having been caused by

Agent Orange?

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Mr. CHAN. Let me say that the Air Force Ranch Hand study

issued a report in 1991, I believe, and observed this finding in

terms of high risk of diabetes for the Ranch Hands. And we were

quite impressed that, in fact, it’s a rather strong study, if anything,

I thought.

But as we stated in our statement, it’s still being considered by

VA as of today. I really don’t know how it’s going to come out, to

be honest with you. But they plan to issue a report next month,

in the year 2000. So I think—— Mr. SANDERS. So in other words, what you are saying is the

Ranch Hand study suggested that diabetes might be caused by exposure to Agent Orange but the VA has not done anything with

that information?

Mr. CHAN. They’ve been asked to further review, obtain more information, and so on. The decision has not been made as of today,

as to whether the veterans should be compensated for diabetes.

Mr. SANDERS. Just say a word or two on a point that you made,

and that is that veterans were concerned that for many years the

scientific community and their representatives were not able to get

the information. Why did that occur? And what would be the effect

of opening up that information to the general population?

Mr. CHAN. As we stated, the only available data that has been

given to the public is the 1987 data, and there were total of five

sets of data, I think. The Air Force is planning to release the information hopefully by this year, but it’s taking a long time. Even the

1987 data was not released until 1995, so it’s taking them quite a

while.

Mr. SANDERS. Maybe they need more money. Maybe $100 million

was not enough.

My last question is recently, on March 3rd, the Vietnamese Government released a report that an estimated 1 million victims of

Agent Orange exist in Vietnam. Obviously, that is an unscientific

statement, I am sure. But that is a heck of a lot of people in a fairly small country. What might that do to our whole discussion about

Agent Orange and the problems that some of our own soldiers have

had?

Mr. CHAN. Well, I think from a science point of view, more information is needed to understand this relationship between herbicide

and health. I do not know, as you said, it’s a very large number

of people exposed and with health problems. So whether in fact one

can verify that or not. I still see it as a very promising area.

Mr. SANDERS. Then my last question leads us to this point. It

would seem that if, in fact, so many Vietnamese are suffering

health effects from exposure to Agent Orange, then that is something the United States Government would want to learn about, if

for no other reason than to see how it affects American soldiers.

Has the U.S. Government done enough to understand the impact

of Agent Orange on the Vietnamese people?

Mr. CHAN. I think some private efforts have been devoted to that.

Mr. SANDERS. There was a study done by some Canadians, and

the Vietnam Veterans of America have been interested. What

about the U.S. Government. Is that not an area that we should be

studying, in your judgment?

Mr. CHAN. Yes, I believe so.

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Mr. SANDERS. Thank you, Mr. Chairman.

Mr. SHAYS. I thank the gentleman. In my opening statement, I

made reference to Lane Evans, who had requested this study, the

ranking member on the House Veterans’ Affairs Committee, and

someone I deeply respect, and a very good friend.

I would like to invite you to make a statement that you would

like to make for the record, and this time would be very appropriate.

Mr. EVANS. Thank you, Mr. Chairman. I appreciate your leadership on this issue and I am glad we are holding a joint hearing.

I think this is a more economical use of our time, our witnesses’ times, so I appreciate that. This may be a rare occurrence in Congress, but I am following my tenant. I am Bernie’s landlord, so I

hope to do as well as you did, Bernie.

I have had a longstanding interest in the effects of herbicide exposure on veterans and their dependents. I introduced legislation

that served as the catalyst for providing compensation to America’s

veterans from the Vietnam era for conditions arising from herbicide

exposure.

I also have worked to ensure that the DOD and the VA make use

of existing medical evidence to make the right decisions about what

conditions should be service-connected and compensated. We must

remain vigilant and your scheduling this important subcommittee

hearing, Mr. Chairman, assures me that you are willing to join on

this watch.

25 years after the official end of the Vietnam war, veterans are

still questioning the effect of their exposure to herbicides, including

Agent Orange, which contains the contaminant dioxin on their

health. The Ranch Hand study was to lay a scientific groundwork

that the Government would use to identify conditions to which veterans might be compensated. It has been the target of much of the

criticism in the veterans community and they have been very vocal

about it.

Because of the new and ongoing allegations, in the fall of 1998,

I requested GAO to examine the Ranch Hand study. As Mr. Chan

will attest, GAO found that there are continuing problems with effective communications with our veterans. In addition, many of the

valid concerns veterans initially had about the Ranch Hand study

still remain.

This January, Senator Tom Daschle and I sent letters to Secretary Shalala of the Department of Health and Human Services,

and to Defense Secretary Cohen. I requested that they provide detailed plans to address the problems reported in the GAO report.

Secretary Cohen has indicated that Brooks Air Force Base would

make the newest data from the Ranch Hand study available to the

Government Printing Office on CD-ROM for a nominal fee, as GAO

has recommended. I am happy to provide a copy of this letter,

along with Secretary Cohen’s response, to your hearing, Mr. Chairman.

I will certainly continue to monitor this issue to assure that interested parties can make use of the complete information. I understand a response from Secretary Shalala is forthcoming.

While I believe that the Ranch Hand study should continue, the

long-standing concerns about its integrity must also be quickly and

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fully addressed. The bottom line is that veterans want and deserve

to be informed about the process and the results of an important

study.

Chairman Shays, Ranking Member Blagojevich, I appreciate the

opportunity to be with you this morning. Again, thank you for asking me to attend.

[The prepared statement of Hon. Lane Evans follows:]

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Mr. EVANS. I would like to ask that those letters be part of the

record.

Mr. SHAYS. Without objection, so ordered.

[The information referred to follows:]

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Mr. SHAYS. Again, thank you for requesting the study and thank

you for all the work you have done over all the years.

I would like to use some of my time to just put on the record and

ask Mr. Chan, Mr. Oppenheim and Dr. Chiu, if you have any response to this. This is a statement from James G. Zumwalt, the son

of Admiral Zumwalt. I will just read his eight points but not the

details.

He said I believe Agent Orange research should not be undertaken by the U.S. Government, especially when research on humans is involved.

He said I believe the Air Force Ranch Hand study contains several major methodological flaws.

He then says data such as the reproduction and development

data collected by the Ranch Hand researchers must be turned over

to trained university-based researchers for evaluation.

He then says published studies, when negative, should always

point out their weaknesses, such as small sample size where rare

events would not be expected to be found because of the limited

numbers, i.e., a group of only 600 exposed men or their children.

He says to be balanced, a scientific study should include a wide

range of expertise.

Point six, the issues raised by the recent GAO report conclude

communications is not good between the Ranch Hand researchers

on the one hand, and the veterans community, the general public,

and other dioxin research on the other. It must be addressed.

We now know dioxins cause increases in the number of various

cancers and cancer related deaths, heart disease related deaths, diabetes, even at general population levels, health problems in children whose mothers experience high dioxin levels, et cetera.

And finally he said, as my father did before his death, I too support dioxin research in other countries where Agent Orange was

sprayed and populations have been exposed, including Vietnam,

Cambodia, and Laos.

I would like you to respond to any of those points that he made.

Mr. CHAN. Generally, I think I have very little disagreement

with what he said. Basically, the only issue he raised is the first

one, which is research should not be done by the Government. I

can certainly understand this perspective, given the past history of

the so-called lack of trust.

I am not quite sure what he’s talking about in terms of the methodological flaw. Maybe it’s because of the generalizability, sample

size issues, and so on. But I don’t—we didn’t address that part.

But certainly, the others I would agree with him. And if indeed,

the last point that’s made about supporting dioxin research, particularly in humans, I think that’s a very important area because,

quite frankly, industry has basically used less and less dioxins for

industrial use. So as a result, you really don’t have a lot of data

out there, people who have been exposed to dioxins, per se, except

our Vietnam veterans, as well as the Vietnamese people.

Mr. SHAYS. Thank you. Dr. Chiu, or Mr. Oppenheim, would you

like to make any comments on anything?

I wrote next to your point one, Mr. Chan, unbelievable. Particularly this statement, also a key update to this study’s findings on

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reproductive outcomes and birth defects was delayed for 8 years

and not released until 1992.

I am going to read it again. Also, a key update to the study’s

findings on reproductive outcomes and birth defects was delayed

for 8 years and not released until 1992. I mean, if you had said 8

months, I would have said that is pretty bad.

Would you comment on why you think that happened?

Mr. CHAN. For various reasons, I think. If you look at it on a

case-by-case, that seems to be a rather egregious problem, in terms

of issuing it. At the time, I think, there were a lot of reasons why

they felt they shouldn’t release the information from the Air Force

perspective. One is because it was not part of the protocol, they

were not required to release the information. They were asked to

look into it more carefully, verify in fact that the birth defects, in

fact, were true because the data collection instrument they used

was basically collected through a questionnaire.

At the same time, given the sensitivity of this information and

the high level of interest there’s really a need to communicate to

the veterans in a timely manner.

So we sort of look at it and wish the interim report was released.

Let me say it in a very different way.

If one designed a research study to gather information in this

manner, then it seems to me that once one receives the results and

determine that where the study requires further examination, suggests that the study itself wasn’t designed well up front. Because

either you have a good study or you don’t have a good study. But

by having a study out there, releasing some of the information, I

think was important.

And indeed, as we said, the checking and verification of the reported birth defects was extraordinary at that time. And in our report, we list a couple of examples where, similar studies did not go

through that kind of checking. We were surprised by it, but it’s also

a very solid way to approach it if you’re interested in research

methods.

Mr. SHAYS. What did we gain? Tell me one thing we gained by

waiting 8 years?

Mr. CHAN. You gain by having a much more solid scientific

study. What you lose is basically, in a different way, the people, the

veterans, if they knew about it, they can in fact use the information in preventive ways, to make sure that their health is OK and

if they plan to have children to take steps to provide the right kind

of care before the child is born. So there is the positive and negative.

I think in here this is pursing the study as an end rather than

pursuing the study as the means toward an end, if I may say it

that way.

Mr. SHAYS. Say that last sentence again.

Mr. CHAN. I said this appears to be a study that becomes an end

in itself. That is, we want to make sure we’re right. We want to

make sure we check everything. First we check the people who

have live births and then you want to make sure that those kids

are OK up to the year 18 years old, and so on. All those are really

the right thing to do.

37

But in a different way, as I said, it’s an end in itself rather than

the means toward and end. The means toward the end is to allow

the veterans to know that—— Mr. SHAYS. It strikes me as somewhat arrogant to think that you

could not release this information and put qualifiers on it, and then

let other people, who happen to be intelligent, and happen to have

knowledge, to look at this information. It strikes me as extraordinarily arrogant that somehow adults could not deal with this information and recognize there was some limits to it.

Mr. CHIU. If I might comment, the advisory committee at that

time was one that pressed for the Air Force not to release their

draft update until they had done the additional verification. So it

wasn’t solely an Air Force—— Mr. SHAYS. You know, additional research, another year, another

2 years. Another 8 years?

One thing we are going to do is we are going to be paying close

attention on what data is being released and so on. I mean, that

is your biggest objection. I think there are others there, and I realize you were not asked to do everything we might have wanted you

to do, but this has been helpful.

Does any other Member have a question, before we get to the

next panel? Do any of the three of you? And Mr. Oppenheim, you

do not lose your job by responding. I can guarantee you, Mr. Chan

is a very good man.

I sometimes believe that the people who accompany the person

who gives the testimony sometimes have more enlightened comments to make. No offense, Mr. Chan. Any other comments?

Mr. OPPENHEIM. I would just add the one comment that I think

Kwai has sort of touched on. And that seems to be this conflict that

exists between the needs to do really credible in-depth research

versus what the needs of the public and the veterans community

are. I think there are a number of steps along the whole sequence

of this research study in which there could have been greater effort

on the part of the Air Force to really communicate what was going

on and to create a really more open kind of research environment

that would engage outside input into the research itself, either

through putting data out that’s accessible to the public, providing

greater opportunities for the veterans to participate in the advisory

committee, and so forth.

So I don’t know how you really deal with that conflict, but it’s

just something that’s existed in this study, and I’m sure it exists

in other studies like this, as well.

Mr. SHAYS. I think we should expunge from the record my comment more enlightened, just additional great comments, in addition

to what Mr. Chan has said.

Mr. CHAN. I would like to raise an issue which I always felt all

along, in doing this study and the work that we’ve done in gulf war

illnesses, is that to me there’s a fundamental problem between the

gathering of the scientific evidence and research in general, versus

policymakers in terms of their intent.

On one hand in science we really want to understand if there’s

a relationship, an association, or correlation. If we find there’s a

correlation, we then want to make sure that there is a statistically

significant relationship. Once we have that, we want to make sure

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there’s a linear dose response. That means the more stuff you have

the worse you get, in terms of your physical well-being. And ultimately, we want to establish cause-and-effect.

Now what we do here, is keep on raising the bar to achieve that

end goal and it’s a very, very important part of science to pursue

in research.

Over time the science wants to establish sort of a beyond a reasonable doubt we are doing the right thing.

On the other hand, I think, Congress, through various legislation

including Public Law 102–4, basically suggests that we wanted to

give the benefit of the doubt to the veterans. That is, if they are

sick, but we can’t clearly establish cause and—— Mr. SHAYS. We just do not want to wait until they die before we

help them.

Mr. CHAN. I understand.

But my point is that the science doesn’t quite support that approach. Giving them the benefit of the doubt means that the risk

for the people exposed is higher for than the normal population. So

the risk means that the percentage of people who are exposed sick,

versus those who were not exposed but sick of the same illness, is

greater than one.

Science doesn’t work that way. It emphasizes in a statistical significance of I want to make sure that 19 out of 20 times I’m correct

in this decision. So as a result then what happens is that scientific

information that—— Mr. SHAYS. I would feel more comfortable though, Mr. Chan, if

this scientific research was being done by a party that was not a

major player, and I would have a greater comfort level. And I believe that, as a policymaker, I have the right to determine that

even there’s not a shadow of a doubt, there’s every indication that,

I’m happy to move forward and commit dollars to helping people.

I just think you give the benefit of the doubt.

I hear your point.

Mr. CHAN. Then what happens is that when the Academy looks

at scientific information what they’re seeing are so-called the——

Mr. SHAYS. They found flaws in the—— Mr. CHAN [continuing]. Beyond a shadow of a doubt. Because if

you have a piece of paper that actually shows that the risk is only

a little higher, you can’t publish that article. It’s not even in the

data base for consideration. Do you see the problem?

Mr. SHAYS. You do not think that information can be shared

without certain caveats that there may have been a flaw here or

there? That they cannot let other researchers look at it and come

to certain conclusions?

Mr. CHAN. I agree with that.

Mr. SHAYS. I need to move on here. Did you want to make a comment, Dr. Chiu?

Mr. CHIU. I just have one short comment and this has to go back

to the very beginning, the inception of this study. It has to do with

scientific credibility versus public and veterans credibility, credibility to the public and veterans.

In 1980, no one questioned the Air Force’s scientific ability to

carry out the science of the study. All the questions were about

whether they could maintain public credibility. What we found, in

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sum, in our report is that many small actions, each of them justifiable in itself. But when you add them all up, it erodes the credibility of the study.

And so I guess, as a lesson for future studies, especially if the

decision is for the Government to conduct them, is to have constant

attention over the lens of public credibility that is going to be focused on every decision in the conduct of that study.

Mr. SHAYS. Thank you. I would like the record to show we are spending $140 million. That is an average of $5.6 million a year.

We are not seeing much to show for this at this point.

I would like to call the next panel. Thank you.

Dr. Joel Michalek, who is Senior Principal Investigator, Ranch

Hand Study, Department of Defense; Robert J. Epley, Director,

Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, accompanied by Susan

Mather, Chief Public Health and Environmental Hazards Officer,

Department of Veterans Affairs; Ronald Coene, Executive Secretary, Ranch Hand Advisory Committee, Food and Drug Administration; and Dr. David Butler, Study Director, Veterans and Agent

Orange Reports, Institute of Medicine.

If you would stand, I would like to swear you all in.

[Witnesses sworn.]

Mr. SHAYS. I would note for the record that our five witnesses

have responded in the affirmative. We have four testimonies and

we will start as I called you and go down the row. Dr. Michalek.

STATEMENTS OF DR. JOEL MICHALEK, SENIOR PRINCIPAL INVESTIGATOR, AIR FORCE HEALTH STUDY ON EXPOSURE TO

HERBICIDES, DEPARTMENT OF DEFENSE; ROBERT J. EPLEY,

DIRECTOR, COMPENSATION AND PENSION SERVICE, VETERANS BENEFITS ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY DR. SUSAN MATHER, CHIEF

PUBLIC HEALTH AND ENVIRONMENTAL HAZARDS OFFICER,

DEPARTMENT OF VETERANS AFFAIRS; RONALD COENE, EXECUTIVE SECRETARY, RANCH HAND ADVISORY COMMITTEE,

FOOD AND DRUG ADMINISTRATION; AND DR. DAVID BUTLER, SENIOR PROGRAM OFFICER, VETERANS AND AGENT

ORANGE REPORTS, INSTITUTE OF MEDICINE, NATIONAL

ACADEMY OF SCIENCES

Dr. MICHALEK. Members of the committee, panel members and

guests, thank you very much for inviting us here today. I’m Joel

Michalek, principal investigator of the Ranch Hand study. I’m always pleased to have an opportunity to tell people about the study.

I want to emphasize that our first concern is the veterans. I’ve

been a part of the study since 1978. We have spent countless hours

with over 2,000 veterans during the physical exam cycles in San

Diego and Houston. We have developed close relationships with

many veterans who risked their lives for their country in an unpopular war. So believe me, we will leave no stone unturned to find

any connection between exposure to Agent Orange and adverse

health effects.

For that reason, we welcome the GAO study and we welcome any

recommendations you may have to help us toward that goal.

40

As our reviewers have described it, due to its size, scope, data

quality, and the use of a biomarker, the Ranch Hand study is one

of the best epidemiological studies ever conducted. Every effort has

been made to adhere to the protocol, collect complete and accurate

data, and obtain unbiased interpretations of the results.

By design, the study has benefited from an independently administered advisory committee of experts in medicine, toxicology and

statistics, biannual review by the National Academy of Sciences,

and submission of all results to peer-reviewed scientific journals.

Peer-reviewed articles in the areas of birth defects and

immunological function have resulted from collaboration with national experts from the Centers for Disease Control and Prevention

and Northwestern University and Evanston Hospital in Illinois.

Research in diabetes, peripheral neuropathy, cardiovascular disease and fertility is being co-authored with faculty from the University of California at Davis, the University of Arkansas, the University of Michigan, Yeshiva University of New York, the University of Southern California and the University of Texas.

My point is that interpretations are made by individuals outside

of the study recognized as experts in their fields. The peer-review

process itself provides an additional level of quality assurance and

rigor. The publication process is long but the effort is focused and

the end result is the best achievable.

In November 1998 an article appeared in the San Diego Union

Tribune that was critical of the study alleging management interference and coverup. I wrote a rebuttal and presented it to the professional staff of the Senate and House Veterans’ Affairs Committee that same month. At the end of the presentation a House staff

member asked me if we would be willing to undergo a GAO audit.

I said yes. Personally, I’m always happy to invite review and critique because I know that is the best way to display the quality

and thoroughness of our work.

Subsequently, through most of last year we gave GAO investigators unlimited access to all documents, including medical records,

electronic data, correspondence, reports and articles. We hosted

them twice at our facility. We produced a randomized and blinded

sampling plan for their review of medical records in their check of

our files against our electronic data bases.

The end result was what we regard as a comprehensive and positive report. The GAO report recommended that we improve our

communication of the limitations of the study and establish a time

table for the release of data to the public. We concur with their

conclusions and have made their recommendations our No. 1 priority.

We now highlight study limitations in our reports, report summaries, and press releases, and have established a timeline for the

release of all data to the public by the end of this calendar year.

We are planning to provide data in easily accessible formats on

compact disks. In an effort to increase communication and available information with veterans and the public we have already

placed executive summaries of morbidity reports, abstracts of our

published articles, all annual reports to Congress and target dates

for the release of our data on our webpage.

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This ends my prepared statement. We would be happy to answer

any questions you may have.

[The prepared statement of Dr. Michalek follows:]

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Mr. SHAYS. Thank you. Mr. Epley.

Mr. EPLEY. Mr. Chairman and members of the subcommittee,

thank you for the opportunity to testify today on the Air Force

Ranch Hand study and its impact on veterans benefits.

The VA agrees with the recent assessment by the General Accounting Office that the Ranch Hand study has had limited impact

on benefits determinations. Our written statement summarizes

VA’s past use of Ranch Hand study data and the general framework within which we make determinations for service-connected

compensation benefits, so I won’t repeat that information verbally

right now.

Public Law 102–4 directed the Secretary of Veterans Affairs to

seek to enter into an agreement with the National Academy of

Sciences to review and summarize the scientific evidence concerning the association between the exposure to herbicides used in support of military operations in Vietnam and specific diseases. The

NAS has submitted three reports as a result of Public Law 102– 4. Those three reports have resulted in a determination that several diseases are associated with exposure to herbicides in Vietnam.

The Ranch Hand study has been considered in each of the NAS

reviews but numerous other studies have also been considered and

have minimized the impact of Ranch Hand findings.

The recent GAO report concluded that the Ranch Hand study

has had almost no impact on VA determinations on which diseases

warrant presumptive service connection because of the small size

of the Ranch Hand population and the relative rarity of the many

cancers. The Department agrees that these and other limitations in

the Ranch Hand study noted by NAS over the years have made its

impact on our determinations very limited.

We believe the review process outlined in Public Law 102–4 has

provided an effective basis for identifying diseases associated with

herbicide exposure. Clearly, the work in this area is not done.

We understand that this committee is concerned about information dissemination to Vietnam veterans and we’re working to improve our outreach efforts.

We look forward to working with NAS and with this committee

to assure that we provide the best possible service, the most informed decisions, and all appropriate benefits to the veterans of our

Nation.

This concludes my statement. Dr. Mather and I will be pleased

to answer any questions.

[The prepared statement of Mr. Epley follows:]

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Mr. SHAYS. Thank you, your statement was concise and right to

the issue, and I thank you for that. I also wanted to thank Dr.

Michalek. Your statement was helpful, as well, and it will enable

us to have a good dialog.

I just want to clarify one thing and then we will get right to you,

Mr. Coene. Did you say you started this study in 1968, Dr.

Michalek? When did you start?

Dr. MICHALEK. Actually, talk about the protocol and its design

stage began, I think, in 1976, was when I was originally hired at

Brooks Air Force Base.

Mr. SHAYS. So you started in 1976?

Dr. MICHALEK. Yes, sir.

Mr. SHAYS. So this is something that you have worked long and

hard on, and I thank you for that work. I know you have been very

devoted.

Whatever else happens in this hearing, I want that to be part of

the record. Mr. Coene.

Mr. COENE. Mr. Chairman, members of the committee, my name

is Ron Coene and I’m the Deputy Director for Washington Operations of the National Center for Toxicological Research. I serve as

the executive secretary to the advisory committee known as the

Ranch Hand Advisory Committee. I’m pleased to be here to discuss

my role as executive secretary to that committee.

The committee, as chartered, advises the Secretary and the Assistant Secretary for Health concerning its oversight of the Ranch

Hand study being conducted by the Air Force, as well as providing

oversight to the Department of Veterans Affairs Army Chemical

Corps Vietnam Veterans Health Study. The committee is made up

of nine members, including the chair, and members are appointed

for overlapping 4 year terms.

My written testimony, which has been submitted for the record,

describes in more detail my role as executive secretary. Let me get

to the substance of the GAO report and concerns of this oversight.

The General Accounting Office report on Agent Orange examined

the Ranch Hand study and recommended that improvements be

made in communication between the advisory committee and veterans organizations. In managing the committee, we utilize the Federal Register the legal requirement to notify the public, including

veterans organizations, of its activities, namely meeting times,

dates, places and preliminary agendas.

In maintaining and assuring the proper mix of committee appointees among veterans organizations, we utilize the Secretary’s

Office of Veterans Affairs to obtain nominations of qualified veterans to fill vacancies on the committee. But we acknowledge that

these informal practices could possibly lead to the perception that

the committee was not fulfilling its role as an independent, unbiased oversight body.

I would like to discuss the steps the Department has taken to ensure that, both in perception and practice, veterans organizations

are being involved in the conduct of the advisory committee’s activities. While the GAO investigation was underway this past summer, these issues became known to us. We took steps to use the

Department’s Office of Veterans Affairs and Military Liaison to

identify and intensify outreach and contact the veterans organizaVerDate 11-MAY-2000 14:16 Dec 28, 2000 Jkt 000000 PO 00000 Frm 00062 Fmt 6633 Sfmt 6633 C:\DOCS\67153.TXT HGOVREF1 PsN: HGOVREF1
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tions concerning the committee’s planned meeting in October of

this past year.

In January of this year, that office began sending letters requesting nominations for vacancies that currently exist on the committee. To date 13 veterans service organizations have been contacted.

Six organizations have expressed a desire to participate in the

nomination process. The Department has received two nominations

each from the American Veterans Committee, the Ranch Hand

Vietnam Association, one nomination from the American Legion,

and three draft nominations from the Vietnam Veterans of America. The Veterans of Foreign Wars also has indicated an intention

to submit nominations.

Additionally, the Disabled Americans Veterans have expressed

the desire to participate by reviewing the list of nominees and providing their endorsement. The Vietnam Era Veterans Association

did not make a nomination but indicated they planned to send observers to the advisory committee meetings. Finally, the American

Ex-Prisoners of War also responded to our outreach but did not

make a nomination.

The Department is continuing to followup with the remaining organizations, seeking their input to this process.

I foresee closing out the nomination process by veterans representatives by early next month and, in consultation with the

chairperson of the committee, we will select two individuals from

each of the three veterans organization vacancies that exist from

the nominations that we have received from the VSOs and forward

them to the Secretary for a final selection. The new members

should be on board in 90 days from the time the Secretary selects

the panel members.

We also are beginning to recruit for other vacancy positions that

exist on the panel. We expect the next meeting of the full advisory

committee will be in late summer to discuss the scope of work of

the contract for the physical examinations of the Ranch Hand

study which will occur in 2002.

Similarly to what we have done for the nomination process, we

will also ensure the veterans organizations are provided, by letter,

logistical and agenda information of advisory committee meetings.

These letters should go out around the time we place the meeting

notice in the Federal Register.

This ends my testimony, Mr. Chairman, and I look forward to

answering any of your questions.

[The prepared statement of Mr. Coene follows:]

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Mr. SHAYS. Dr. Butler.

Mr. BUTLER. Good morning, Mr. Chairman, Mr. Sanders. My

name is David Butler. I am Senior Program Office in the Institute

of Medicine, a private non-profit organization that provides health

policy advice under a congressional charter granted to the National

Academy of Sciences. The Institute of Medicine has three ongoing

studies related to the evaluation of the health impacts of herbicide

and dioxin exposure on Vietnam veterans.

I serve as study director for all three studies, which include the

third biannual update of the ‘‘Review of the Health Effects in Vietnam Veterans of Exposure to Herbicides;’’ the ‘‘Review of Evidence

Regarding a Link Between Exposure to Agent Orange and Diabetes; and Phase Three of the Historic Exposure Reconstruction

Model for Herbicides in Vietnam.’’

In response to the request of the subcommittee, I will review the

status of these studies, what’s been learned to date, and future

study plans.

As Mr. Epley stated, the Agent Orange Act of 1991 directed the

Secretary of Veterans Affairs to request the National Academy of

Sciences to do an independent comprehensive review and critical

evaluation of the scientific studies and medical evidence concerning

the health effects of herbicide exposure. This act prompted the first

of the three research efforts I will briefly review.

A committee convened by the Institute of Medicine conducted an

initial investigation and in 1994 published the report ‘‘Veterans

and Agent Orange.’’ The Agent Orange Act also called for subsequent reviews every 2 years for a period of 10 years from the date

of the first report.

The committees responsible for these studies evaluate epidemiologic and toxicologic data on exposures to the types of herbicides

used in Vietnam and the contaminant dioxin. The epidemiologic

studies comprised three primary categories: occupational studies,

such as those conducted by NIOSH; environmental studies, like

those conducted in the aftermath of an industrial accident in

Seveso, Italy; and veterans studies, including the Ranch Hand

studies. Information from all of these sources is considered in

drawing conclusions.

Based on their evaluation of the scientific literature for Update

1998, the committee found sufficient evidence of a statistical association between exposure to herbicides and dioxin and four conditions: chloracne, soft tissue sarcoma, non-Hodgkin’s lymphoma and

Hodgkin’s disease. The committee found limited or suggestive evidence of an association with respiratory cancers, prostate cancer,

and multiple myeloma. They also found limited or suggestive evidence that exposure may be associated with porphyria cutanea

tarda, the acute transient form of peripheral neuropathy, and the

congenital birth defect known as spina bifida in the children of fathers who were exposed to herbicides.

For most of the other cancers, diseases and conditions reviewed

by the committee, the scientific data were not sufficient to determine whether an association exists.

The third biannual update is presently underway and is scheduled to be completed by the end of this year. The future plans for

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this research effort are to complete the mandate specified by the

act.

A second Agent Orange research effort being conducted by the

National Academies was prompted by the 1999 request from the

Department of Veterans Affairs to call together a committee to conduct an interim review of the scientific evidence regarding one of

the conditions addressed in the ‘‘Veterans and Agent Orange’’ series of reports, Type II diabetes.

The committee convened for this review examined studies published since the deliberations of the Update 1998 committee in

light of the whole of the literature on the subject. Their draft report

is presently under review. It is expected to be released in May of

this year.

The third research effort underway addresses one of the greatest

problems encountered by the Agent Orange committees in their

work, a severe lack of information about the exposure of Vietnam

veterans to herbicides. In response to this information gap, the Department of Veterans Affairs requested that the National Academies help facilitate the development and evaluation of models of

herbicide exposure for use in studies of Vietnam veterans.

For this effort, a committee developed a request for proposals for

research and invited interested individuals and organizations to

submit responses. Committee members thoroughly evaluated the

technical and scientific merit of these responses and unanimously

concluded that a proposal submitted by Professor Jeanne Stellman

of the Columbia University School of Public Health and colleagues

merited funding.

In the present phase of the project, the research proposed by the

Columbia University group is being conducted with the continuing

oversight of the committee. Most recently, in December 1999, the

researchers reported on the progress in developing a data base of

military units that served in Vietnam, improving the data base of

herbicide spraying missions, developing models of troop movement

and otherwise establishing the information foundation for their

modeling work. Present plans call for this research to be completed

by the end of 2001.

These three research efforts comprise the work on the Agent Orange issues presently being supported at the National Academies.

Thank you.

[The prepared statement of Mr. Butler follows:]

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Mr. SHAYS. Thank you very much. Again, I want to say that I

know that every one of you is a dedicated public employee and

wants only the best for our veterans. I just want to establish that

for the record. And I know that you all have lots of responsibilities

and you are doing your best to fulfill them well.

When I ask some of these questions, they are going to basically

relate to my sense that you are players in a bigger picture. And

you may play out your part, but in the end, do we get what we

need from what happens?

I also acknowledge that this study basically was fairly limited

and that there is a general consensus that the GAO findings are

accurate and there will be efforts to comply with their recommendations. Frankly, their recommendations are fairly limited

and center primarily on communications.

But let me first ask you, Mr. Coene, I am unclear. This study has

gone on from 1982 and it will be concluded in the year 2006. It is

a 25 year study.

Mr. COENE. Correct.

Mr. SHAYS. You became the director of the advisory group when?

Mr. COENE. In 1989.

Mr. SHAYS. In 1989, and you work for the Food and Drug Administration?

Mr. COENE. Correct.

Mr. SHAYS. This is, in a sense, one of your assignments?

Mr. COENE. It is.

Mr. SHAYS. This is not your primary assignment?

Mr. COENE. No, sir. I’m the deputy director of NCTR, National

Center for Toxicological Research. It was an assignment that the

Secretary asked us to take on.

Mr. SHAYS. I get the sense that the facts support, and you kind

of concede, that this advisory group has not been all that active

and that it has had vacancies?

Mr. COENE. We have vacancies at the moment, but we have always had a quorum at any of our meeting?

Mr. SHAYS. What is a quorum?

Mr. COENE. A quorum would be five, sir.

Mr. SHAYS. And how large is the committee?

Mr. COENE. Nine.

Mr. SHAYS. How often have you met?

Mr. COENE. We have met 12 times over the period since 1989,

since I have taken the responsibility.

Mr. SHAYS. Just say that again and then tell me what you think

about that?

Mr. COENE. We have had 12 meetings over the last 10 years, approximately one a year. And we responded to the need to review

information that the Air Force was producing and also oversighting

the scope of work for the next round.

Mr. SHAYS. The sense I get is that you view yourself more as a

responder rather than a catalyst.

Mr. COENE. That would be a correct characterization. We responded to the need to oversight information and, at least during

the period that I have been executive secretary to the committee.

Mr. SHAYS. I do not want to dwell on this, sir, too much but I

will tell you that I find that sad because it would strike me that

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veterans deserve a catalyst in an advisory group. I think your view

of your responsibility is very different than mine or most veterans.

And I think it points out to some of the reason we are in this mess.

Dr. Michalek, you have been working, the reason I interrupted

the flow is I just thought I was not hearing right and I wanted to

ponder. You have been working on this project since when?

Dr. MICHALEK. Actually, I was hired at the School of Aerospace

Medicine in 1976. I was, prior to that, an assistant professor at

Syracuse University in upstate New York.

Talk about the Agent Orange issue and the possibility of writing

a protocol began in 1977, shortly after I was hired. I co-authored

the protocol. I was involved with the planning stages and during

the protocol review. The protocol was reviewed by the Armed

Forces Epidemiologic Board, for example, the National Academy of

Sciences, the Air Force Scientific Advisory Board during the period

1978 roughly to 1980.

During that period, all of the issues that we have talked about

today were talked about in great detail. For example, should the

Air Force do the study at all? What about this limited sample size

and the limited power? What about this possibility of using other

control groups? What about the exposure metric? All of those

things were discussed in great detail. And there’s an audit trail

showing all of these discussions in minutes of the meetings.

Many of the resolutions of those discussions were described in

the protocol. All of the concerns that we mentioned today actually

are discussed in the protocol. So we have visited these issues many

times.

Mr. SHAYS. Which is to say we were forewarned?

Dr. MICHALEK. We ourselves were faced with a daunting scientific issue, as to how to study—how to apply an epidemiologic

template in an unprecedented setting, where we did not know the

disease outcome and we did not know clearly who was exposed

among the Ranch Hand unit. We knew that the best scientific

method was to isolate that group which we could identify and

which we could be reasonably assumed to be heavily exposed,

namely the Ranch Hand unit.

The prerequisites were already satisfied. We had military records

to show us who was in the Ranch Hand unit. We could identify

them. And we believed, from standard epidemiologic and industrial

hygiene concepts, that this group would be candidates for the most

exposed cohort in the entire Vietnam—or one of the most exposed

in the entire Vietnam population. Not that there are not others. In

fact, we’ve talked about those today already. For example, the

Army Chemical Corps veterans.

So yes indeed, all of the principles that we’ve talked about today

were mentioned and clearly argued out back in the late 1970’s.

Mr. SHAYS. So would it be your conclusion that this was a mistake for us to begin this study?

Dr. MICHALEK. It was not a mistake to begin the study. In fact,

it has been an unprecedented and noble effort on the part of the

Government to launch a study of this magnitude in a situation

where there was widespread fear about the possible consequences

of exposures.

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We launched a study without knowing what we were going to

find. We committed funds, we committed resources, and we committed people to a long-term epidemiologic effort, not knowing what

the outcome was going to be. That was a very noble effort on the

part of our Government and I’m proud of it.

Mr. SHAYS. But what do you think the outcome is?

Dr. MICHALEK. The outcome is that we have an unprecedented

wide data base and collection of data of unprecedented scope and

quality to address the issue. If you’re asking me about findings,

that’s a different question.

Mr. SHAYS. So right now the outcome so far is that we have a

data base and the data base is not being shared very willingly with

the rest of the scientific community.

Dr. MICHALEK. I’d like to address that, for a minute. You’re talking about data release.

Certainly, the concept of data release has evolved over the last

25 years. In fact, 1977–1978 the issue of data release was never

mentioned by any of our review bodies during the time that we

were writing the protocol. Data release was not mentioned in the

protocol specifically.

In fact, the idea of data release has evolved in the entire scientific community since the middle 1970’s, to the current time

where I actually attended a National Academy workshop in December on the gulf war. The prevailing attitude there is that in all federally funded studies from this point forward, data will be released

to the public immediately. That’s an unprecedented decision. And

that illustrates the evolution of attitude and philosophy that has

taken place since the middle 1970’s.

So to take you back to the middle 1970’s, in 1978, 1979, certainly

the intent of the study and of the principal investigators and of the

advisory committee was to conduct a credible and scientifically defensible effort in this direction, although data release itself was not

specifically mentioned.

Among the principal investigators, of which I am one, and by the

way I was appointed principal investigator in 1985, our attitude

has been No. 1, we will release to the public that data which we

are sure is correct. And No. 2, we will not change any data. When

we receive data from the clinics, such as in Houston or in San

Diego, the data bases remain untouched. If we find mistakes, data

in the computer which doesn’t match with data on the records, we

make fixes or corrections in our computer code. So that our attitude

there was that this was as much a legal investigation as it is a

medical investigation.

So with those two constraints that we had self-imposed ourselves

back in the early 1980’s, we have already made data release very

difficult. It can’t be done quickly.

On top of that, we have privacy concerns with the veterans themselves. The immediate release of data, if not carefully done, would

certainly violate privacy because names and Social Security numbers and other private information are in many of these datasets.

And when you speak about data you need to realize that there

are many different kinds of data that are in our possession at

Brooks Air Force base, not just computer data files. We have approximately 4 million documents collected on the medical records

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from the men themselves, their children, and their wives. And we

have approximately 50,000 specimens of biological materials such

as serum, adipose tissue, urine, and semen in our institutional

freezers. We have an archive of information on these individuals

that’s very extensive. Data release has to be done very carefully.

Another constraint on data release that you may not be aware

of is that when this study began our emphasis was on carefully auditing data release such that it could be made official. That meant

we would release data through the National Technical Information

Service in Virginia. At that time, in 1978, 1979 and early 1980’s,

the prevailing computer technology was far different from what it

is today. Computers were—datasets were in very crude what are

called flat file format, where they had to be individually documented. That was the requirement for the National Technical Information Service, that they receive what are called flat files.

The other constraint is that once an agency such as us releases

data to the National Technical Information Service, it can never be

retrieved. Meaning that whatever we give out, we can never get

back. That puts a constraint on what we release, because we want

to release data that contains no mistake. In other words, data that

can be item-by-item verified as being the same as what is in the

medical record.

So the data release concept is as difficult and perplexing for us

as it is for you.

Mr. SHAYS. I want to be clear for the record. The record is I want

to be clear that I am understanding, Mr. Epley, what you said. Basically, your testimony is to date the Ranch Hand study has not

been a factor one way or the other in decisions made on compensation to veterans, in terms of their general health care? That is the

essence of what I got.

Mr. EPLEY. That’s correct.

Mr. SHAYS. So really where we are right now, in my judgment

is——

Mr. EPLEY. With one exception, Congressman, if I may. In the

issue of spina bifida, that was material.

Mr. SHAYS. OK. Dr. Michalek, what I still wrestle is you are basically saying that we were told things would turn out the way

they have. I am not quite sure I am comfortable with that. In other

words, everything we are talking about now was talked about when

we began this study. All the concerns about data release and so on.

I get the sense that, in a way, that this is turning out to be a

study that will be great for scientists and great for someone who

follows maybe years from now, so I do not belittle that part in that

sense, our solders to come. But in terms of the Vietnam veterans,

by the time we are going to get some solid information from the

data that is still not being disseminated and still being developed,

that they are almost—I do not want to say guinea pigs in a bad

sense, but they have provided all of this information but they may

not benefit from it. That is the sense I am getting.

Dr. MICHALEK. I think the conflict has been described already by

Dr. Chan from the GAO. There’s definitely a conflict here between

expectations and reality, as far as science is concerned.

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When we say, for example, that our first published article occurred in 1990, you need to know that work on that paper began

in 1986, only 1 year after the second physical.

Mr. SANDERS. Excuse me for interrupting, you are really not answering the Congressman’s question. I think basically what he was

saying is we are spending $120 million. There are a whole lot of

interesting scientific questions out there. Although neither of us

were in Congress when this process began, we presumed that what

Congress wanted to know and wanted to learn was how Agent Orange affected the men and women who served in Vietnam. That is

what they wanted to learn.

And what Mr. Epley has just told us, what Mr. Chan has told

us, is basically we have learned very, very little from Operation

Ranch Hand in terms of how that affects our soldiers who were

over there and how we can provide compensation to them.

So it may be the world’s greatest scientific and epidemiological

study, but in terms of what the U.S. Congress wanted, I would

agree with the chairman that apparently we have not gotten a

whole lot for that.

Mr. SHAYS. I am going to give you a chance to respond. I guess

the bottom line is my sense is that that was what, an unrealistic

hope? An unrealistic expectation?

Dr. MICHALEK. All I am saying is that the timelines in science

are much longer than the timelines in public health policy. It takes

up to 7 years to get an article published in a peer-reviewed journal,

for example. It took us——

Mr. SANDERS. Let me jump in and say something. You know, we

are talking about people who believe that they are dying, that their

kids are being affected. And it takes 7 years to get a peer-reviewed

article accepted? Well, do something about it.

In other words, this gets back to the point. We are not dealing

with some academic exercise. You are dealing with the lives of

Americans who suffered in that war. And to say well, it takes 7

years for us to get it peer-reviewed is unacceptable.

Can you respond to that?

Dr. MICHALEK. Yes, I can. Of course, we have two different kinds

of products from the study. We have un-peer-reviewed Government

reports that we put out subsequent to every physical examination,

each numbering in the thousands of pages. We’ve produced approximately 20,000 pages of reports, all of them available through

the Government Printing Office. They’re all official Government reports summarizing every single physical examination.

So that all of the data you’ve just mentioned has been described

already in those reports. Separately, we intend and are publishing

the data from those reports in a distilled form in research articles

published in scientific journals. So that the immediate timelines

you’re talking about are met by the Government reports, not by the

journal articles themselves which come out many years later.

Mr. SHAYS. Go ahead, Mr. Sanders.

Mr. SANDERS. Thank you, Mr. Chairman.

The advantage, in some respects, for scientists testifying before

a congressional hearing is that Congressman do not necessarily

know a whole lot about science. But you know what we do know

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about? Do you know what we are the world’s greatest experts

about? It is outreach.

Because if we were not good in outreach, we would not be here.

Whether it is Mr. Shays, myself, Mr. Bush and Mr. Gore, they have

to reach out to the people or else they do not get elected. Right?

That is what politics is all about.

So we know a whole lot about outreach. We spend a whole lot

of money on outreach, et cetera.

Now I would like to ask Mr. Epley to describe, and I want to

thank him and Dr. Mather for joining me last week in my office

to go over some of these issues. After all is said and done, we have

about 7,585 men and women who are receiving benefits for health

effects due to Agent Orange. Is that a correct number? That is the

number you gave me, and I am presuming it is.

Mr. EPLEY. That number is accurate in reflecting the Vietnam

vets who are receiving service-connected compensation due to the

presumptive conditions.

Mr. SANDERS. I have nine diseases listed, I guess spina bifida is

not here, so maybe there are some more.

We had approximately 3 million men and women over there; is

that correct? And probably nobody in the world knows how many

of them were exposed to Agent Orange and so forth?

Mr. EPLEY. That is the best number I’ve heard, sir.

Mr. SANDERS. Off the top of my head, would you agree with me

or disagree with me, Mr. Epley, it would seem to me that 7,585

folks receiving compensation is a pretty small number. Would you

agree or not agree?

Mr. EPLEY. Relative to the number of veterans that served in

Vietnam, it is a low number. If I may, I would add to that, though,

the number of people who are receiving compensation who asserted

disability from Agent Orange is higher. Let me explain that, if I

may.

We have about 99,000 vets, a few more than 99,000 veterans

from Vietnam who have claimed service-connected benefits and asserted that their disability related to Agent Orange.

Mr. SANDERS. 99,000.

Mr. EPLEY. Right. The 7,500 comes out of that population. But

also out of that population, about 65,000 of those veterans are service-connected for one or more disabilities. They’re not the disabilities on the presumptive list. But that number certainly is a more

representative figure.

Mr. SANDERS. So 99,000 came forward requesting benefits?

Mr. EPLEY. Yes, sir.

Mr. SANDERS. 66,000 are receiving benefits?

Mr. EPLEY. About, yes.

Mr. SANDERS. And 7,500 are getting——

Mr. EPLEY. I need to add to that. Some of those veterans may

be service-connected and at the zero percent. We did a data run to

determine how many of the 99,000 have one or more service-connected conditions. That’s the 65,000-plus. Some of those could be

zero, so they may not all be receiving money, but certainly the vast

majority of the 66,000 are receiving compensation.

Mr. SANDERS. Explain to us why, if 99,000 came forward, understanding that people are receiving benefits for other things, only

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7,500 approximately are receiving benefits from exposure to Agent

Orange?

Mr. EPLEY. That 7,500 represents the number of Vietnam veterans who have one of the presumption conditions, the 9 or 10 on

your list. It is a low number, but we did a quick check based on

the Agent Orange studies and our informal discussion on expectations. And the 1993 study, the Agent Orange study did do some estimations of what populations they would expect to see by the year

2000 to have contracted the conditions.

The numbers are not that different from what we have in our

7,500 list. By example, the 1993 study said the expected cancer

cases among male Vietnam vets in the year 2000 for non-Hodgkins

lymphoma would be 494. We’re paying 1,464. For prostate cancer,

their expectation in 1993 was 855 and we’re paying 1,441.

Mr. SANDERS. But if I can interrupt you, that’s an interesting

statement. But in fact, these prostate cancer and the other illnesses are on this list because we have concluded that exposure to

Agent Orange causes these problems. And so the real question to

be ask is, given the fact that X numbers of people were exposed,

is the numbers that you have here a reasonable response to those

numbers? Do you understand what I am saying?

Mr. EPLEY. Yes, sir.

Mr. SANDERS. So we are not talking about the general population, we’re talking about those who, in fact, have been exposed

to Agent Orange, which is a cause of these illnesses.

Off the top of my head, I would say that is not a particularly

high number.

Mr. EPLEY. I understand.

Mr. SANDERS. Mr. Epley, let me ask you this, we held a town

meeting in Vermont a couple of weeks ago and the question I asked

the veterans who were there is they really have not heard a whole

lot about this issue. They do not know what they are entitled to.

And you can disagree with me if you want, please.

I would say if we did a poll of Vietnam vets and we said to them

do you know what particular illnesses the Government has determined were caused by exposure to Agent Orange, of which you are

entitled to benefits, would you think a large number of the vets

would know that?

Mr. EPLEY. I think that a large number would not be able to recite the conditions.

Mr. SANDERS. I know that. I do not mean as an exam. But I

mean to say if I was a Vietnam vet, which I am not, and if I had

prostate cancer, do you think I would automatically say geez, I

read something and I know that that is something that might be

caused by Agent Orange? Do you think the average vet would know

that?

Mr. EPLEY. I think there is a general understanding that it’s an

issue to be pursued and I think that’s indicated by the number of

vets who have filed claims. It’s indicated by the number of vets

who, at least initially, applied to the Agent Orange lawsuit that

you referred to earlier.

I think there’s a sense that hey, I can go somewhere and pursue

this. Maybe not much more than that.

83

Mr. SANDERS. Would you be willing to guess, and we do not have

the information, that there are perhaps thousands of veterans who

served in Vietnam who were exposed to Agent Orange who have

prostate cancer and have no idea that they are entitled to benefits

from the United States Government? Would I be right or wrong, do

you think?

Mr. EPLEY. I think there are some.

Mr. SANDERS. Some?

Mr. EPLEY. Yes.

Mr. SANDERS. Do you want to broaden that; 1, 2, 5,000, how

many? I know you do not know.

Mr. EPLEY. I don’t know.

Mr. SANDERS. Let me ask you this question, and we discussed

this last week. You gave me, and I appreciate you giving me this,

some pretty good publications. How many of these do you publish,

and who reads them?

These are publications, for the record, Agent Orange: Information

For Veterans Who Served in Vietnam, general information. And

also, there is an ongoing publication called Agent Orange Review.

How many of these do you publish? Does the average veteran get

this? Or is this really for the scientific community or the veterans

organizations?

Ms. MATHER. The Agent Orange Review, which is the newsletter

that comes out several times a year, goes to all of the veterans who

have signed up for the Agent Orange registry exam. And as of February 24th, that was 298,234 veterans. So that many goes out.

Also, copies go to the veterans service organizations who are our

strongest ally in outreaching to veterans. The Vietnam Veterans of

America do a wonderful job of outreaching, as does the American

Legion and the VFW and the DAV.

Mr. SANDERS. So approximately 300,000 of these go out.

Ms. MATHER. Those go out to individuals.

Mr. SANDERS. Right, that is a lot, and that is good. The problem

is we had about 3 million men and women over there. What effort

are you making to reach out to the others, A. And B, I am a great

fan of the service organizations, and I think they do a very good

job, and obviously they must be involved. The Vietnam Veterans of

America, VFW, American Legion, DAV must be involved in this effort.

But the fact of the matter is that we have 27 million veterans

in the United States and less than 3 million of them belong to the

service organizations. And some of them belong to more than one

organization. That leaves about 25 million veterans who are not in

contact with the service organizations.

What effort is being made to reach out to those people? For example, and you and I discussed it, how many town meetings have

you had on this issue? How many PSAs have gone out? How many

press conferences have you had around the country? How would

the average veteran, who is not associated with the VSO, know

what he or she might be entitled to?

Mr. EPLEY. We do do regular town meetings through the regional

office system that we have. This year we have scheduled 59 standdowns, which is a process that we do at various locations around

the country to provide general benefits dissemination. It’s not

84

geared specifically to Agent Orange, but general benefits dissemination, general medical——

Mr. SANDERS. How do you advertise those meetings? How many

people come to those meetings? How do you advertise them?

Mr. EPLEY. They’re advertised locally, basically through the medical system.

Mr. SANDERS. How many folks might attend those meetings?

Mr. EPLEY. At the ones that I’ve attended, it has ranged from

150 to 300.

Mr. SANDERS. And you are explaining the benefits that veterans

are entitled to?

Mr. EPLEY. Yes, in a very informal way, but it’s set up to allow

the vets to come in and look for what they need.

Mr. SANDERS. I am going to invite you to Vermont to do that.

Mr. EPLEY. I think I knew that was coming.

Mr. SANDERS. But in addition, I have to tell you something. I

have been working on an issue of prescription drugs and veterans.

As you know, of course, that if a doctor examines a veteran, that

veteran is entitled to prescription drugs at, I think, $2 a prescription which is an enormous saving for many veterans.

Do you know what? In the State of Vermont many, many veterans did not know that that benefit existed. I am sure that that is

true all over America. I sent out a newsletter. We probably had 300

veterans respond to it.

If veterans do not know that they are entitled, going through the

VA, to get inexpensive drugs, I have my doubts about how many

of them are going to know about the benefits that they are entitled

to through Agent Orange. Would you agree with me?

Mr. EPLEY. It’s hard to know. If you don’t know, you just don’t

know. You don’t know where to go.

Mr. SANDERS. I heard Mr. Coene talk about the service organizations, but I am concerned about your being overly dependent on the

service organizations. In other words, how are you going to get to

the vast majority of the veterans who are not members of service

organizations? What is your plan?

Mr. EPLEY. We do have a toll-free number available to veterans,

on which we receive about 10 million phone calls a year for general

benefits information.

Mr. SANDERS. When people call what do they get? A human

being? Do they get a tape recorder? What do they get?

Mr. EPLEY. They get a human being. They get an opportunity to

go to the team that manages their case, if they have an active case.

They do, in some instances, get an interactive voice response if

they’re looking for general information. They can do that automatically.

Mr. SANDERS. You got 10 million calls.

Mr. EPLEY. About 10 million a year is what we respond to.

Mr. SANDERS. For information about veterans benefits?

Mr. EPLEY. We do the stand-downs, as I mentioned. As Dr.

Mather mentioned, we do the newsletters. We also notify veterans

on the registry when there are results from the NAS reviews. We

let them know that there’s potential change in the benefits, and

those are to the 300,000.

85

Mr. SANDERS. Would you agree with me that if we have about

10 percent of the folks who were over there on the registry, yes?

That is not a particularly high number is it?

Mr. EPLEY. No.

Mr. SANDERS. What are we doing to increase the number of people? I mean, it sounds to me like you are trying. Dr. Mather indicated that you are trying to do a good job in communicating with

the folks who are on the registry. The concern is the 90 percent of

the vets that are not on the registry.

Mr. EPLEY. One of our main focuses or foci recently, in terms of

outreach, has been to separating servicemen. I know that that does

not apply directly to this population. But we have initiated a

project under transition assistance where we are trying to reach

out and give full orientation of benefits to departing servicemen before they leave the service, so they get an understanding of the full

range of benefits.

Last year we conducted about 80,000 personal interviews in that

effort and we’re expanding to the point now where we have VA personnel either permanently or itinerantly at about 60 of the major

separationsites.

Mr. SANDERS. I think that that is, by the way, a very good idea.

I was told by at least one veteran so I do not know if it is the

God’s truth or not, that this information is not often seen at VA

hospitals. Are these publications available? Are they on the racks?

Ms. MATHER. They are sent out. They have been very popular.

I think the fact that they may not always be available is just our

inability to keep up with the demand. That just did come out this

year, however.

Mr. SANDERS. But what I mean is do you make, in terms of trying to get the word out, do you send this to every VA hospital in

the country?

Ms. MATHER. We do send these, yes.

Mr. SANDERS. And you will insist that they put in a place where

veterans can pick it up?

Ms. MATHER. Yes.

Mr. SANDERS. Let me just ask Dr. Michalek a question. How do

you respond to the recent information that came out from the Vietnamese Government that they estimate that there are 1 million

victims of Agent Orange in Vietnam, suggesting that it is a very

serious health problem over there. They suggest they have a million victims, and I know that that is totally unscientific and an estimate. And we have 7,500 men and women who are collecting Federal benefits from exposure to Agent Orange.

What do we learn from the serious problems that may be existing

in Vietnam? Does that mean anything to you?

Dr. MICHALEK. Yes, it’s meaningful to me because, of course, if

you’re going to look for people who were exposed, that would be the

place to go. And to see evidence of concern over there and a counting of individuals with adverse effects should motivate more research. In my opinion, I’m not saying agency policy here.

Mr. SANDERS. But you said that might be the place to go?

Dr. MICHALEK. Yes.

Mr. SANDERS. Have we gone?

86

Dr. MICHALEK. I understand that certain individuals have visited. We’ve seen video of Dr. Arnold Schecter, for example, visiting

Vietnam. We know the Canadians are there, taking very systematic sampling.

Mr. SANDERS. But what about the U.S. Government?

Dr. MICHALEK. I have not seen any official—personally, I haven’t

seen any official evidence of United States involvement in Vietnam.

Mr. SANDERS. Again, I am not a scientist but it would seem to

me that if I wanted to learn about the impact that exposure to

Agent Orange might have on human health, I might want to go to

that place where people were most exposed.

Now whether the Vietnamese Government is right or not that

there are 1 million victims, I do not know. We have heard, and I

am sure you have heard anecdotally and probably seen photographs, of children who were born with birth defects and other

problems.

I do not quite understand how people who are studying the impact on Agent Orange on human health have not quite made it

over to the country where the exposure seems to be most great.

Anyone want to comment?

Dr. MICHALEK. Personally, I agree with you completely.

Mr. SANDERS. Thank you.

Mr. SHAYS. Dr. Butler, I would like to draw you in here a bit,

and I think that Congressman Sanders has made an obvious statement. This is not our expertise, but the value of this is that if you

can explain it to us, then the rest of the world can understand it.

Mr. Chan kind of introduced this in talking about the certainty

of scientific research versus our needs and policy. In your testimony, you talked about how you are basically in charge of three

epidemiological studies in three areas: the occupational studies, environmental studies, and veterans studies.

Excuse me, you are doing three studies: the review of the health

effects of Vietnam veterans exposure to herbicides; review of evidence regarding link between exposure to Agent Orange and diabetes; and phase III of the historic exposure reconstruction model for

herbicides in Vietnam?

Mr. BUTLER. That’s correct.

Mr. SHAYS. You are looking at the occupational studies, environmental studies, and veterans studies?

Mr. BUTLER. Yes, sir.

Mr. SHAYS. You then make the point, you say the committees

have found a common approach established by the first committee

to summarize their evaluation of the evidence. They have classified

disease into four categories. The first category, sufficient evidence

of a statistical association between the disease and exposure to herbicides or dioxins. The second, limited or suggested evidence. The

third, inadequate and insufficient evidence to determine whether

an association exists. And the fourth category, limited suggested

evidence of no association.

Mr. BUTLER. That’s correct.

Mr. SHAYS. When we have to look at what you do to determine

compensation, what level should we be at?

Mr. BUTLER. That’s a policy rather than a scientific decision.

What the committees were tasked with doing was doing a comVerDate 11-MAY-2000 14:16 Dec 28, 2000 Jkt 000000 PO 00000 Frm 00090 Fmt 6633 Sfmt 6633 C:\DOCS\67153.TXT HGOVREF1 PsN: HGOVREF1
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prehensive review of the scientific information and presenting a

consensus opinion, if you will, looking at—— Mr. SHAYS. That it would be one of the four categories you described?

Mr. BUTLER. That’s right. In trying to summarize a vast amount

of scientific literature on this subject, scientific groups in the past

have used general categories like this to try to give a general feel

for where the consensus of the science is.

This particular set of categorizations was one that was first used

by the International Agency for Research on Cancer and was subsequently borrowed by this committee.

Mr. SHAYS. Well, you did not really answer the question, but I

will come back to it because this is helpful. I guess what I am trying to come to grips with is, in your work, have you relied on data

from Ranch Hands? Are you basically waiting for information?

Tell me how you would like to utilize the information from this

25 year study.

Mr. BUTLER. Ranch Hands is one of the studies that is carefully

examined by National Academy of Sciences committees when they

reach their conclusions. It isn’t the only piece of information,

though.

For example, there is also information available from the Australian Commonwealth Department of Veterans Affairs on their

Vietnam veterans population.

Mr. SHAYS. I understand you are not going to just wait for this, but we are spending on an average $5.6 million a year. We are hoping that this study has more than just outcomes on more than just

data. I am just trying to ask you, it has not been very helpful to

date to the Department of Veterans Affairs.

I guess we could do the inverse and say well, it could be helpful

in one sense, we could take the inverse and say well, we are not

feeling we have to compensate anyone yet, or many people. So it

has not put many people on our list. And some could interpret it

to say that so far there is nothing that has caused us a proactive

effort to do that.

Now from my standpoint I may not be pleased with that, but

that would be one potential result. But I guess what I am asking

you is has this been very helpful to you?

Mr. BUTLER. The Ranch Hand study is a helpful study as part

of our examination of the whole of the literature. There’s no one

study that’s going to be determinative.

Mr. SHAYS. I accept that, but my sense is, and correct me if I am

wrong, but my sense is there has not been much information disseminated.

Mr. BUTLER. We have reviewed a number of reports over the

years in the three Veterans and Agent Orange studies. I’m afraid

I don’t have an exact number, but we carefully examine any information that is published by the Ranch Hand researchers.

Mr. SHAYS. I feel like I am playing chess with you here. The reality is we have got a fairly concise comment from VA that, to date,

it has not resulted in their finding many people to compensate as

a basis of this report. I am asking you if you have gotten much information here? And did you expect that you would get more sooner?

88

Let me just say, I do not want you to carefully consider your

words here. Just as you do not rely on this for the total basis for

all your studies, your answer is not going to be the total on my conclusions. I just need to get an answer.

Mr. BUTLER. It is a helpful study. I can tell you that Dr.

Michalek has always been forthcoming in providing information requested by the National Academy of Sciences committees, and has

been mindful of the observations committee members have made,

the suggestions for future work, and for ways to improve the study.

Mr. SHAYS. Let me ask you this question. Did you have an expectation that you would get more information and you would get that

information sooner?

Mr. BUTLER. The Academy does not form any expectations of any

study of this sort.

Mr. SHAYS. That is not what I asked. They have information that

has not been released, they have studies that have not yet been released. Did you expect you would get information and studies sooner? It is a simple question.

Mr. BUTLER. We expect that we will get the information from the

studies, yes, as quickly as it’s available. We want as much information as possible to consider in making our decisions.

Mr. SHAYS. I am going to ask it again and we will have a long

time here, because it is really a simple question and it is a waste

of time for you to be here if you are not going to answer basic simple questions. It is a yes or no.

Am I am not saying I am going to like your answer. Did you expect that you would get information sooner? And did you expect to

get more information than you have received to date?

Mr. BUTLER. Did we expect to get information sooner?

Mr. SHAYS. And did you expect to get more information than you

have received to date?

Mr. BUTLER. No, I don’t believe we expected to get information

sooner and no, we don’t have any expectation about getting specific

information in the future, except that we are hoping to get as much

as possible as soon as possible.

Mr. SHAYS. So your expectations were pretty low, frankly. They

certainly were lower than our expectation.

Mr. BUTLER. In our job, in reviewing all the information, we can

only deal with what’s out there. We don’t have the ability to initiate specific studies or to drive the pace at which others provide information for the committee’s consideration.

Mr. SHAYS. I understand that. That is not really what I said. I

know you cannot force the information sooner, but you might have

had an expectation you would get it sooner. And your answer is no.

You had really no expectation that you would get it any sooner

than you have. And that is helpful information, and I thank you

for finally answering the question.

I am going to ask you the first question again. You shared the

fact that you classify diseases into four categories. I am asking you

to give me your opinion, and that is the way I accept it, as your

opinion.

At what level do you think Government should consider compensation? Should we have a no shadow of a doubt? The reason

why I am asking the question is I have come to the conclusion,

89

based on our work that we have done on gulf war illnesses, based

on our review of Agent Orange, that I have to be honest with our

veterans. By the time we will know the scientific data, you are

dead. You will either have died early or you will have died in your

old age in pain, but you will not get help from the Federal Government.

That is the honest answer that I have to give people, if in fact

we have to wait until we have 99 percent certainty. What Mr.

Chan said in the beginning, I think, is very helpful to me and it

explains, Dr. Michalek, your approach. You are a statistician and

an expert in your field and you are doing your job as best you see.

And you have already said that a lot of these questions we have

raised were discussed early on.

But it is an eye-opener to me because my view is that I do not

want to wait until you have 99—maybe I would like to be 70 percent certain and then I am willing to go to my taxpayers and say

you are going to pay more to help veterans who were sent to war.

And maybe I am saying it because when my colleagues were in

Vietnam I was in the Peace Corps. Maybe a whole host of factors

are coming into play.

You are a scientist, I am a politician. I am asking you to step

aside from your position as a scientist now and say is there some

solution short of being 99 percent certain where we can say it trips

over and, you know, the odds are, and why do we not compensate?

Is there any solution to this mess I find myself in, of having to wait

until we are 99 percent certain?

Mr. BUTLER. The Academy gives its opinions on the scientific information.

Mr. SHAYS. I understand that.

Mr. BUTLER. The policy decisions are very clearly outside of the

mandate for the committees, and the committees have never offered an opinion on the policy decisions which are made on the

basis of that.

Mr. SHAYS. And so you choose not to offer an opinion?

Mr. BUTLER. I don’t feel it’s my role as a study director to offer

a policy opinion.

Mr. SHAYS. Now you have an opportunity to make a contribution

separate. That is not unusual. We get witnesses here and we say

my God, you have worked on this for years. You are restrained by

your science and you are going to follow that, you have an opportunity.

And you refuse to give an opinion?

Mr. BUTLER. I appreciate the opportunity, Mr. Shays. In my role

as the person who facilitates this study, it’s my belief that I do that

job best if I act as a neutral, unbiased conduit of information to the

expert committees that are formed by the National Academy of

Sciences who come to the decisions that are made in these reports.

Mr. SHAYS. And therefore, you have decided not to answer that

question?

Mr. BUTLER. That’s correct.

Mr. SHAYS. So who do we turn to? Let us go to the VA. What

I am trying to do is I am not going to wait until we are 99 percent

certain. You are going to do your science and you will be in your

nice rooms and you will do it and the veterans will be guinea pigs

90

because they will be there and they will provide all your wonderful

data. And we have this outcome, all this data, and they literally

grow older. Some of their children are raised and they are not well.

And maybe they should have been compensated by us, but we

are not 99 percent certain. Is there any scientific level that we

could turn to, short of 99 percent, that would give us some way to

come to a conclusion here?

Ms. MATHER. I believe that the Congress gave the Secretary of

Veterans Affairs that charge in the legislation, in which he took

the reports that the National Academy of Science and Institute of

Medicine gave him, and then made a policy decision as to what diseases should be service-connected.

In reality, we’ve accepted all the diseases for which the National

Academy of Sciences found there was sufficient evidence of an association, and limited or suggestive evidence of an association.

Mr. SHAYS. That is the top category, is it not?

Ms. MATHER. The top two categories.

Mr. SHAYS. So you have to meet sufficient evidence of a statistical association or limited or suggested evidence? I do not think

that is true.

Ms. MATHER. That is, in fact, what the Secretary has decided

over time, over the 3 years.

Mr. SHAYS. Now do you release reports, Dr. Michalek, that would

come to a conclusion? Do you grade according to these four categories?

Dr. MICHALEK. No, sir, and I’m not aware of any other study that

does. That’s an activity carried out by the National Academy of

Sciences for reviewing all studies.

Mr. SHAYS. So when you release your studies, what do you have

to be certain of?

Dr. MICHALEK. We’re not really certain of anything when we release a study, except for the fact that we’ve done the best job we

can. We render an opinion at the end of any article or report suggesting an interpretation of the data, as to whether we think this

indicates a relation between exposure and disease or whether it

does not. Those interpretations are read by the National Academy

of Sciences and all of our reviewers.

So yes, we do offer an opinion about whether or not there is a

relation between herbicides and exposure in every article and every

report.

Mr. SHAYS. And how do you grade those opinions? What are the

levels? How do you grade them? Do you say yes, no, or maybe?

Dr. MICHALEK. Well, the language that’s used in these reports is

not conversational. For example, a statement in an article or report

that the data suggests an adverse relation between herbicides and

health is, in the scientific literature, a very strong statement. And

that’s about as strong as it gets in any scientific article or report.

Mr. SHAYS. Suggested evidence?

Dr. MICHALEK. Yes, suggested. And that’s the material that the

NAS uses to render an opinion that’s ultimately used by the VA.

Mr. SHAYS. And is suggested evidence one level below, in your

opinion, sufficient evidence?

Dr. MICHALEK. I think it’s—yes, second level up.

Mr. SHAYS. Do you have any questions you want to ask?

91

Mr. SANDERS. Mr. Chairman, one thing occurs to me, based on

this discussion, especially with Mr. Epley, that we as a committee—and it is your decision of course—but at some point we, as a

committee, might want to take a look, a general look, at how well

the VA does in terms of its outreach for veterans benefits in general, beyond Agent Orange.

Mr. Epley, veterans have told me that it is sometimes a very difficult process, in terms of filing a claim for a service-connected compensation regarding Agent Orange, in terms of not receiving a fair

hearing. Is that true, in your judgment?

Mr. EPLEY. No, I don’t think so. The filing of the application is

a fairly simple procedure. The adjudication of the claims for the

presumptive conditions should be very simple. That is the intent of

it. If the veteran served in Vietnam and if the veteran has contracted one of the diseases on the presumptive list, they should be

service-connected. Then we’re only dealing with the level of evaluation.

Mr. SANDERS. But I am told by some knowledgeable people that,

in fact, that is the case in some of the offices. But in fact, in other

offices there is a great deal of foot dragging, denying claims, and

making spurious requests. Do you think you have an across-theboard process where all of your offices are responding well?

Mr. EPLEY. I think we have a process that is clear and understood. I would suggest that there is not a level of consistency that

we need in the administration of it day-to-day.

Mr. SANDERS. Doctor, you indicated a moment ago what I think

is common sense, that you think that the U.S. Government should

probably go to Vietnam to start studying the situation. When will

we expect that study to be done?

Dr. MICHALEK. First of all, I’ve offered to go myself and that’s

still under discussion in our group. As to when it should begin, that

will require a mandate on the part of the Government to provide

the resources and the apparatus to get something started. I would

say as soon as possible, because the longer we wait, the more difficult it would be.

Mr. SANDERS. Require a mandate. Small groups without a whole

lot of money, like the Vietnam Veterans of America could send over

a group of people.

Dr. MICHALEK. It’s not enough.

Mr. SANDERS. I agree with you. So what kind of mandate? That

is your job, is it not? You are studying this issue.

Dr. MICHALEK. The mandate would be similar to the mandate

that established this study, to set up an advisory panel, to write

a protocol, to define the concepts.

Mr. SANDERS. Let me tell you something, based on what I have

heard about this study, that would be precisely the last thing that

I would suggest that we do. It would be another 20 years before

anyone got there.

Dr. MICHALEK. It does not have to be a 20 year study.

Mr. SANDERS. Mr. Epley, maybe you and I could speak later.

Mr. EPLEY. May I add one comment? You mentioned outreach

and we are undertaking a study of the outreach efforts in VA, VBA

specifically, to determine whether or not we’re meeting the statutory intents for outreach and if there are gaps what we need to do

92

to pursue them. As soon as they’re available, we’ll be glad to talk

with anyone who’s interested.

Mr. SANDERS. I would be very curious to see that. Thank you,

Mr. Chairman.

Mr. SHAYS. Thank you very much. I appreciate all of the witnesses. Your testimony was helpful, very helpful, and very educational. So that was appreciated.

At this time, I would like to call the next panel. Thank you.

Our first witness is Dr. Richard Albanese, Senior Medical Research Officer, U.S. Air Force; Dr. Linda Schwartz, associate research scientist, Yale University School of Nursing, consultant,

Veterans Health Care; and Dr. Ronald Trewyn, dean of graduate

school and vice provost of research, Kansas State University,

former member, Ranch Hand Advisory Committee.

I would invite the panel to stand and I will swear you in.

[Witnesses sworn.]

Mr. SHAYS. I appreciate all of you being here for the other panels. It helps us because you have heard from them and you can

make comments.

For the record, all three of our witnesses have responded in the

affirmative and we will start with you, Dr. Albanese.

STATEMENTS OF DR. RICHARD ALBANESE, SENIOR MEDICAL

RESEARCH OFFICER, U.S. AIR FORCE, FORMER RANCH

HAND PRINCIPAL INVESTIGATOR; DR. LINDA SCHWARTZ, ASSOCIATE RESEARCH SCIENTIST, YALE UNIVERSITY SCHOOL

OF NURSING, CONSULTANT, VETERANS HEALTH CARE; AND

DR. RONALD TREWYN, DEAN OF GRADUATE SCHOOL AND

VICE PROVOST OF RESEARCH, KANSAS STATE UNIVERSITY,

FORMER MEMBER RANCH HAND ADVISORY COMMITTEE

Dr. ALBANESE. Thank you. I am an Air Force medical research

officer whose travel here has been funded by the Air Force. However, my testimony does not necessarily reflect Air Force policy.

I was a principal investigator in the U.States . Force health

study, the Ranch Hand study, from 1978 through 1984. I am one

of four authors of record primarily responsible for writing the protocol, with Colonel George Lathrop, Colonel William Wolfe, Colonel

Patricia Moynahan and myself. We’re the four authors of record of

the study protocol.

During my time with the Ranch Hand program, I observed two

protocol violations. These were the lack of veteran representation

in the science review process and command influence.

Mr. SHAYS. What was the second?

Dr. ALBANESE. Command influence.

In my opinion, the lack of Vietnam veteran representation denied

veterans and their families a fair assessment of health effects associated with Vietnam service. Important on-the-ground operational

dimensions, and critical study limitations were missed.

The command influence directly altered report content. In my

opinion, this also denied veterans a fair assessment of their health

status.

Protocol violations, in my opinion, are quite serious. We advertised to the veterans who came and allowed themselves to be examined that they would have their interests protected by representaVerDate 11-MAY-2000 14:16 Dec 28, 2000 Jkt 000000 PO 00000 Frm 00096 Fmt 6633 Sfmt 6633 C:\DOCS\67153.TXT HGOVREF1 PsN: HGOVREF1
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tives in the science review process. We violated their right of informed consent when we failed to do that. And command influence

is effectively scientific misconduct.

These issues were addressed in the 1980’s. The legislation passed

after the 1988 hearings apparently did not fully correct the problems in the Air Force health study. Public Law 100–687 requires

the study monitoring group to conform to the study protocol with

one-third veterans representation.

The December 1999 GAO report to the Honorable Lane Evans relates that veterans participation has been incomplete or erratic, despite the public law. As you read in the report, there were individuals who were representing veterans who didn’t know they were

representing veterans. Similarly, the December 1999 GAO report

indicates that study limitations have not been fully and clearly

communicated to the public.

In my opinion, the effects of limited veterans representation and

poor communication are apparent in the scientific reports issued by

the Ranch Hand study. Of very great concern to me are birth defects and cancer in this group involved with spraying herbicides.

Also, I perceive seriously inadequate data flow to veterans concerning heart disease, vascular disease, neurological ailments, endocrine disturbances and hematological difficulties.

Timely full clear reporting can assist medical personnel to better

care for veterans. And it is my definite medical opinion that the

men in this study need care today. And what they need today relates also to what other veterans need today.

The hierarchical structure of the military organization, which is

excellent to conduct war, can compromise scientific and medical research. I am concerned that the recent failures to report the Ranch

Hand study properly are institutionally influenced. I recommend

that the Air Force adapt integrity programs such as the Office of

Scientific Integrity in the NIH and the FDA program to improve

the way they clear research and other papers for publication.

I personally have experienced management changing a concluding sentence in an article even after that article was cleared by the

Air Force and accepted in the open literature. This is not an every

day matter, but there are no protections, that I’m aware of. About

10 percent of my medical articles have been thus changed. How can

I view Dr. Michalek and his people as free, intellectually free, when

I know that I am not and my other senior colleagues are not?

Clearance processes may be OK when you’re building missiles,

but it makes no sense in medical research. It makes no sense in

medical research.

For nearly 20 years, the Ranch Hand study has been unable to

properly include veterans in the scientific review process. And for

nearly 20 years this study has only reported part of the truth. Real

veterans’ representation can occur and reporting can improve in

this effort if GAO recommendations are energetically and scrupulously followed.

I concur with the GAO recommendation on data release to the

general public, but I advocate full, full, full data release to individuals who are qualified to protect subject confidentiality, individuals

at medical schools and university who would sign a document

agreement to protect confidentiality.

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And there’s no issue about letting data go that has error. You

publish the data that you’ve used to write your report and you earmark it as such, and every scientist knows the limitations of such

data. I am concerned that full data publication will not occur.

I strongly advocate funded replication and analysis of Ranch

Hand work by independent and qualified individuals. I would like

to think the data itself will attract professors, but if it doesn’t I

think funded studies to replicate are necessary.

If integrity programs are not strengthened and if veterans are

not included, and if data are not really shared, then at the risk of

loss of time and data—and remember, my medical judgment is

these men are ill—I recommend study transition to another agency.

Thank you.

[The prepared statement of Dr. Albanese follows:]

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Mr. SHAYS. Thank you very much. Dr. Schwartz.

I am assuming that you work at the West Haven Hospital as a

consultant? But you are at that facility or not?

Ms. SCHWARTZ. No, I am not attached to the VA. I am a consultant to the Secretary of Veterans Affairs in several areas, mostly

women veterans. And I am myself, of course, a veteran. And my

work, my research has been—— Mr. SHAYS. But the important thing is you come from Connecticut.

Ms. SCHWARTZ. But I do not come from your district, I’m sorry.

Mr. SHAYS. That is all right. I am magnanimous, it is a great

State. Welcome. I was trying to be positive.

Ms. SCHWARTZ. First of all, you are positive. By having this hearing you are positive. You and Mr. Sanders have done an excellent

job and you have done a service for the veterans of our Nation.

Let me explain that yes, I am retired from the U.S. Air Force

Nurse Corps. I have had the opportunity to several times speak to

the National Academy of Science groups when they were considering their reports. I have completed a study on women veterans, the

health needs of women veterans who were stationed in Vietnam.

And I have just returned from Vietnam and can address some of

the issues that you have raised about research in that country.

I would first of all like to say that one of the issues that has been

raised earlier this morning, the cost of this study, is somewhat

ironic given the fact that it costs approximately $140 million. And

when you talk about the class action suit which was done to help

the veterans, the cost of that suit was $180 million. That’s how

much chemical companies gave veterans to assist them with the

needs that they had.

I would also add that the Vietnam Experience study, which has been noted earlier today, was 8 years in the making and $43 million. And at the end of all that time and all that money, they decided they could not do the study. So that’s what we’re dealing with

here.

I would just like to refer to some of the more important issues

that I brought out in my written testimony.

There is no doubt that the dioxin TCCD, which was very evident

in Agent Orange is a carcinogen. In a recent discovery of a case in

New Brunswick, Canada, evidence made public during the litigations between the Sprayers of Dioxin Association and Dow Chemical Co. and Uniroyal clearly shows that in 1965 the manufacturers

of TCCD knew that it was dangerous, it was a potent carcinogen,

but decided to make a pact to keep that information secret not only

from our Government but from any people that purchased the

chemicals.

In the GAO report, the one thing that I would like to stress is

the fact that we have paid a great deal for this study and we have

used very little of the data. And although the GAO report refers

to the fact that we could be looking at what Air Force has already

done, from a scientific point of view I say that this is a very rich

field of information that has not completely been analyzed.

And so, with that in mind, and to build on my own work of looking at women veterans, the Yale School of Nursing, where I am an

associate in the research department, has become a repository for

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information on the Ranch Hand study acquired from several

sources. I would just like to say that while Dr. Michalek said that

these reports are available, you indeed can get those reports that

he has talked about. But it will cost you about $1,500 to get them.

So that’s the cost of getting those reports. And they are not readily

available, nor are they easily understood by the average veteran.

However, we did go ahead and try to—we did acquire the 1987

dataset which was the variables from the physical examination

which was made available in the public domain. The cost was $454.

At the time we made the order, it was for the cartridge format.

When we got the cartridge format at Yale, we took it to all of our

computer laboratories and we even went to some of the commercial

sources in the area, and some of the businesses in the area to try

to access that data.

So yes, you can buy it. You can’t read it. When we made that

order, I would like you to know that when we made the order we

said well, we’ll have to make a copy, we don’t keep this in stock.

How would you like it? We said we would like it on CD-ROM. But

that was denied. And so we got these rather antiquated formats for

the information. And now, we are going to try a second try at an

additional fund to that.

I also would like to say that when I read the GAO report and

it talked about the reporting in 1992 of the study of birth defects,

I checked the U.S. Air Force Health Study Internet and found

that—I said how did I miss that, 1992? Well, it was published in

Helsinki, Finland. And if I wanted a copy of that article, I would

have had to write to the Health Institute of Finland. Not knowing

that, I was not aware until the summer of 1998, when the Air

Force actually did put forth that report, that there was a report on

the birth defects that were studied in 1984.

One of the greatest limitations that has escaped the public and

many veterans are the fact that findings from the Ranch Hand

study are not applicable to all Vietnam veterans. The stated purpose of this study was to determine of Ranch Hand personnel were

adversely affected by their proximity and handling of Agent Orange. And I have heard Dr. Michalek on several occasions at the

advisory committee meetings reiterate that.

In other words, the question was are Ranch Handers sicker than

other Air Force personnel who served in Vietnam? If you look at

the study from that aspect, then some of this falls into place. However, many of us did not know this, and I did not know this until

I heard Dr. Michalek say that for sure.

However, the stature of the U.S. Air Force and the fact that very

few other studies could afford to perform serum dioxin levels—and

just so you know, if you want to have a serum dioxin level done

by our CDC it costs $1,000 per person. So you can see right away

that there are many studies that could not afford, and many would

not be funded if they asked for funding for this. So Air Force had

the gold standard in many respects, because they had the capacity

to access serum dioxin levels.

Another point of potential bias is the fact that all the subjects

and the controls in this study were in Vietnam at one time. And

although the control group did not actually handle and spray Agent

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tionately larger exposure to the dioxin than other military personnel.

As I said, I have just returned from Vietnam where we received

a briefing from the Hatfield Consultants of Vancouver, British Columbia. The Hatfield Consultants have been working in Vietnam

since 1969, specializing in environmental assessments of the

human and ecological consequences of large dioxin contaminations.

I want to tell you that they really shocked us. They reported

that, and I am going to tell you that my statement must be amended at this juncture where I referred to this. Because in my statement I say some of the most barren spots the dioxin level was

1,000 points per trillion. That was not true. It was on the site of

a former United States base, military base in Vietnam that the

1,000 points per trillion soil dioxin 25 years later was obtained.

And so you must realize that that is not a barren spot. That is

where our troops were working on a daily basis.

In addition, I wish to also amend my statement after talking

with Mr. Hatfield last night. What they found in the food that people eat, even to this day, in a place called the Aloui Valley, which

many Marines will remember, is their finding that in the food it’s

65 points per trillion in the ducks and the fish that they are getting from there. And it’s 30 points per trillion these many years in

the blood and breast milk of people who live in the Aloui Valley.

Another point of potential bias that is not widely known is the

fact that in this study limited confidentiality extended to the active

duty personnel that participated in the study. Unlike most research, confidentiality of answers and information obtained during

the study is a sacred covenant between the researcher and the subject. However, in this particular instance, the Ranch Hand protocol

stated that active duty personnel would not be given complete confidentiality. Instead, they were told that the DOD would be notified

if any of the information they provided was a risk to public safety

or national defense.

In essence, this limited confidentiality proviso could have threatened the promotion potential, the flying status, and retention in

the Air Force of the active duty personnel who participated in the

study and should challenge the validity of the responses given by

these individuals.

Last year, in addressing the issue of the study’s conduct to prevent improper influences, last year I attended two meetings of the

Ranch Hand Advisory Committee which reviewed the findings prior

to the publication of the findings of the last round of examinations.

The notice of the first meeting was indeed published in the Federal

Register, under the FDA, probably the last place a veteran would

look for a meeting about the Ranch Hand study.

Thoughtful suggestions for improvements in presentation of the

data, concerns about the interpretations of the findings, and suggestions about the protocol were made by members of the advisory

committee. However, I have to say that one of the things that came

up over and over again was Air Force researchers repeatedly countered that it would be difficult and costly to carry some of these

suggestions out.

Mr. SHAYS. If you could bring it to a close.

Ms. SCHWARTZ. I will. Let me just say this.

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The Agent Orange Act of 1991 authorizes presumed service connection disability for diseases from certain herbicides. One of the

things it says, and maybe you don’t have to fix this, is that an association of a disease in human and exposure to herbicide is considered to be positive of the credible evidence of an association is

equal to or outweighs the credible evidence against the association.

With these parameters in mind you can see that the fact that the

Ranch Hand data has not completely been made available, and not

all of their associations, only the statistically significant associations. This means that there may be data there that could help us

understand more about what the exposure is about.

I just would like to say, in closing, that war, like any other

human catastrophe, must be acknowledged as an important occupational epidemiological event. And you, Mr. Shays, has certainly

pioneered the way for gulf war veterans and Vietnam veterans.

And I would just like to say that by continuing to have Government entities with a vested interest in the outcome of science to be

allowed to continue to do research is not the way to go because

there are too many questions about the credibility.

And the idea has been put forth as a freestanding institute of

military medicine and I think it is something that as we progress

we must take a very good look at and consider for the future.

I thank you for your time.

[The prepared statement of Dr. Schwartz follows:]

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Mr. SHAYS. Thank you very much. We have a vote. I am going

to go vote and we are going to come right back and, Dr. Trewyn,

you will get to have your say.

You were kind to your comments to me at the end. I just want

to say that Mr. Sanders has actually done more than I have in this

area, and it has been wonderful to work with him.

I will convene you all and I will be right back after I vote.

[Recess.]

Mr. SHAYS. I will call the hearing back to order.

Mr. Trewyn, you have the floor. Doctor, excuse me. You spent

many years getting that doctor, did you not?

Mr. TREWYN. I did, more than I would like to talk about, sir.

I want to thank you for the opportunity to provide a few brief

comments here today. I will try to be brief. I know this has been

a long day.

Most of my comments are in my written testimony. It gets into

a lot of science but I was sort of inspired by Representative Sanders to maybe try a couple of common sense sorts of arguments here.

Mr. SHAYS. Common sense is not allowed.

Mr. TREWYN. OK, I will rethink that and go back to the other

thoughts.

Mr. SHAYS. No, common sense is allowed, we will take it.

Mr. TREWYN. What I’d like to talk about are briefly scientific

problems, administrative problems which have been alluded to before. To just let you know how I got involved in this, I did spend

4 years on the Ranch Hand Advisory Committee from 1995 through

1999.

Mr. SHAYS. As a doctor not a veteran? No, you said you were on

the advisory committee. Were you appointed as a veteran or as a

doctor?

Mr. TREWYN. Well, I’ve never been quite sure. It was, in fact, Admiral Zumwalt who got me appointed.

Mr. SHAYS. I am not looking for a long answer, I am looking for

the short answer.

Mr. TREWYN. And I don’t know the true answer.

Mr. SHAYS. That tells me something.

Mr. TREWYN. I was asked that by the GAO and I didn’t know the

answer and I don’t know if they ever found it when they went

through the paperwork.

But I did spend 20 years of my life doing cancer research and

most of that with a focus on chemical carcinogenesis, so I do have

some scientific background in the area.

What I want to just briefly mention, and this is outlined in my

written material, are three scientific hypotheses that one can look

at here. The first one that started this whole thing is that Vietnam

veterans are suffering from excessive health problems and those

health problems are service-connected, connected to their service in

Vietnam. That is what launched all of this, and that really remains

the most important question or the questions that underpin that

remain the most important ones to answer.

But somebody figured out that, you know, we sprayed a lot of

herbicides in Vietnam. Those have some nasty things in them, so

maybe the herbicides sprayed in Vietnam caused adverse health

outcomes in veterans who served there. And that, in fact, is more

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the question that the Ranch Hand study is designed to test, is that

it was a causal relationship of herbicides.

But because Agent Orange, the major herbicide sprayed in Vietnam, contains dioxin—and we’ve heard a lot about that today,

TCDD, it moved to a third hypothesis and that is that dioxin, a

minor contaminant found in some of the herbicides sprayed in Vietnam, caused adverse health outcomes in the veterans exposed to

herbicides.

If I could just give a quick example that will maybe illustrate I

think where our problem is with this whole thing right now, and

it’s a forest and trees argument. If you were standing in the middle

of a redwood forest and some of the trees are sick. We’ve gotten to

the point where it’s no longer an issue that you can’t see the forest

for the trees. People aren’t even seeing the trees anymore in this

study.

We’ve focused down on, in my hypothetical, a small beetle burrowing into the bark of some of those sick trees. We’ll call it a

dioxinite beetle, just for something novel. And you invest 25 years,

$140 million and come up with the assessment at the end, you

know, that little beetle caused some problems for those trees.

But when you step back and look around, you realize there are

no more trees. There’s no more forest. We have lost sight of what

the original issue here was, which was health effects, and sir, some

of your predecessors in Congress have to bear some of the blame

here, because I truly believe the Air Force is doing what they were

mandated to do, what they were charged to do, to study a possible,

at the point in time, a probable cause.

Now because they may not be finding as many adverse health

outcomes as we would like to see doesn’t mean if we were examining the right population, the veterans who were there on the

ground in general, this might not show up.

I could go into a lot of discussions about synergy, something

you’ve probably encountered in your discussions of the Persian Gulf

situation, mixtures of chemicals, biological agents. I spent a lot of

time in my career studying those things. Where a couple of small

effects can become a huge effect when you put things together.

There are lots of suspects in Vietnam beyond dioxin, that may

have caused adverse health outcomes.

To just mention briefly a couple of administrative items, from my

role as a member of the oversight committee. In my view, the advisory committee lacks authority, it lacks appropriate reporting lines.

For example, the committee never files a report with the Secretary

of Health and Human Services which is then provided to Congress.

There’s nothing like that. We talked to the Air Force and for the

most part, or did when I was involved and it still goes on. And for

the most part, they listened to our comments and recommendations

on that committee.

But also, I believe the advisory committee lacks sufficient resources to function properly. The first meeting I attended after

being appointed in 1995, the committee voted, as a body, very busy

people, a number of MDs and other experts on this committee,

voted as a body that we needed to meet every 6 months to really

monitor this effectively, both the Ranch Hand study and the later

congressionally mandated Army Chemical Corps study.

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When we next got together 3 years later, we were informed that

well, you know, there really is no budget. The FDA does not have

a budget to do this job. It’s just been passed down, an unfunded

mandate. They’re supposed to call this group together as need be

and well, we didn’t have the money and there weren’t pressing

issues.

And I don’t blame Ron Coene or the other people in the FDA. It’s

a fact of life. They don’t have—he has a job, a regular job, and this

has been passed down without the resources to get the group together to adequately monitor the study.

I do believe that there are studies going on that could be fixed

and made better. The Army Chemical Corps study has some great

potential to yield positive results, hopefully in a relatively short period of time. I’d be a lot more comfortable with that if the VA

wasn’t involved in it. I’m a combat wounded veteran with a serviceconnected disability. I stay as far away from the VA as possible.

I’m not on the registry for exposure.

The Vietnam Experience study, that group, if the study was

structured properly, the records are there, could still be looked at.

And this is more than a veterans affairs issue. It is, in fact, a

national security issue. Because if the country continues to treat

their veterans poorly and, in some cases, abominably as has been

the case with the veterans suffering from adverse health outcomes

from Vietnam, from the Persian Gulf, we’re not going to meet the

recruitment and retention needs in this new era of needing highly

educated, highly technically proficient people. They aren’t going to

stay in because why should they, when they know what’s going to

happen going out the other end?

So I really do believe this is an opportunity for Governmental reform and some oversight on this, and trying to tie it to, at least

as I read the mission of this group, of looking at how to address

these needs. And hopefully, something can be done about this.

Thank you for this opportunity.

[The prepared statement of Dr. Trewyn follows:]

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Mr. SHAYS. Thank you. I think you were more than generous to

the advisory committee because frankly, there are people who

would serve at their own expense. They would come at their own

expense. And the fact that you do not know whether you were a

veteran appointee or appointed in terms of your medical expertise

tells me something. I suspect you were not a veterans appointee.

And it raises questions in my own mind, and I should have asked

Dr. Coene, when he said he had a quorum of five, can I make an

assumption that the five who were usually there were not veterans

because we had not been filling the spots with veterans? Which

also says somethings to me about the veterans organizations, that

they were not pushing this organization.

But I chose not to dwell on that, because I think it is pretty evident.

Mr. TREWYN. I was told that it was the American Legion who

recommended my name, but I do not believe the GAO ever found

any record of it, and I never had anything official that indicated

that.

Mr. SHAYS. Then you may have been an appointee of the veterans. The bottom line is not to meet for 3 years just boggles the

mind. It certainly was different than what we anticipated.

Dr. Albanese, would you elaborate on your concerns about the

1992 IOM reports on birth defects and cancers?

Dr. ALBANESE. Yes, sir. When you compare the Ranch Hand

sprayers with their control group, there’s a more than 50 percent

excess in the group that has sprayed. Now that birth defects excess, using current analytical techniques, does not regress linearly

on dioxin. But that group difference exists.

I am one of four authors of that protocol. The purpose of this

study was to determine whether Agent Orange is associated with

problems. There’s also a portion in the protocol which says we’re

concerned about the Vietnam experience.

We have sitting on the table a greater than 50 percent increase

in the birth defects. And because it doesn’t have a linear regression

with dioxin, which is not the only dangerous contaminant in Agent

Orange, we’ve ruled it out. And in the IOM report we have a statement which says let there be an independent analysis of this data

because they severely criticized this.

Mr. SHAYS. Does this relate to, Dr. Trewyn, your comment on

your first page on the bottom, with multiple agents and the potential for synergistic activities among them, there may be no way to

sort out the relative importance of different levels of exposure to

individual components in veterans with different genetic backgrounds and susceptibilities. And synergy is a well-known phenomenon in chemical carcinogenesis and other disease progressions?

Mr. TREWYN. That is correct. And in Agent Orange, 2,4-D being

essentially 50 percent of the mixture, which has been shown to

cause problems. Weed-B-Gone is how it’s currently marketed. But

that has problems. You put dioxin, which came in in the other component, 2,4,5-T, you put those together and I don’t know that anyone has ever scientifically studied the potential for synergy that

these two things together could cause a much greater effect than

either alone.

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And those are just a couple of possibilities.

Mr. SHAYS. Ms. Schwartz, do you have any comment?

Ms. SCHWARTZ. I think the thing is that Ranch Hand was designed to look at Ranch Handers. What happened was because they

honed in on the ability to be able to measure dioxin, that became

the coin of the realm when indeed it should not be the coin of the

realm. And statistical significance should not be the way in which

you decide what things are compensable disabilities.

So that’s why I’m saying if you could look into the Ranch Hand

data, you could probably see if there were any other things that

had a greater than 50 percent chance—— Mr. SHAYS. Do you have access to that data?

Ms. SCHWARTZ. There is no access to the data at this time. As

I said, we have the tapes. We just don’t have—we cannot read the

data.

Mr. SHAYS. If we spent an average of $5.6 million a year, and

I should probably ask this to others, but it would strike me that

the relative cost of transferring that onto manageable equipment

would allow so many people to look at this data and we might come

up with some other conclusions.

Ms. SCHWARTZ. That was the intention of the Yale School of

Nursing, to transfer it to CD-ROM and then to say if anybody

wants this data, you have to pay for the CDs but we’ll make the

copies for you.

Mr. SHAYS. So one thing that this committee could do that would

make a contribution would be what would the cost be to convert

this data to a consumable?

Ms. SCHWARTZ. Right.

Mr. SHAYS. You know, Doctor, if you do not mind coming up now,

you could just respond to that. There me things and you are more

than welcome to come down.

One, I appreciate you staying here. It is appreciated.

Ms. SCHWARTZ. I think, just to answer and I probably shouldn’t

steal Dr. Michalek’s thunder, but the idea of making that data

available and something that can be used has been on the Internet

for quite some time. The delay, we don’t see that.

Mr. SHAYS. Doctor.

Dr. MICHALEK. I understand your frustration. We are preparing

a series of CD-ROMs to be released to the public this year. Each

CD-ROM will contain the full report and all supporting data bases

and they will be in there as both flat files and as sass files. We

promise to have all this out by the end of calendar year 2000.

Mr. SHAYS. Thank you. Will that be a help, Dr. Schwartz?

Ms. SCHWARTZ. I will be eagerly awaiting this, especially if it’s

in a sass file.

Dr. MICHALEK. Absolutely. For example, we’ve already released

the birth defect data. Everything that has been published is now

released. The dataset itself is out there at NTIS. I would invite

anyone who wants to have access to the data and it’s inconveniently formatted, just send me a message and I’ll send you a sass

dataset.

Ms. SCHWARTZ. I don’t think that the birth defect data is there.

If you sent it there, it’s not there and it is not available to the public.

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Mr. SHAYS. This dialog is helpful because we can, by the fact that

we have a public dialog about this, we can do our job as a committee and just make sure it happens the way it should.

Ms. SCHWARTZ. I would just like to say, as a way of informing

everyone, that the VA did complete a study of the birth defects associated with women veterans. Agent Orange was not in the—was

not considered in that because of the presumption that if you

served in Vietnam you would be eligible for this, and that the Secretary of Veterans Affairs found that the high rates of birth defects

in women and the children of women who served in Vietnam was

so high that he did make an announcement that they would be

making efforts to compensate these women and their children.

And as much of a women’s advocate as I am, I see that we really

need to proceed as soon as we possibly can—— Mr. SHAYS. Do you think that is happening?

Ms. SCHWARTZ. Yes, it is happening.

Dr. ALBANESE. Congressman Shays, I think it’s very important

for me to say, based on what Dr. Schwartz just said, I studied that

report on the birth defects to female veterans. The pattern in the

Ranch Handers is nearly identical to the pattern in that study. But

because they didn’t meet the standard of a linear increase with

dioxin, the fact of that difference hasn’t been further pursued.

That’s the tragedy of it.

Mr. SHAYS. Let me just say, Doctor, you might be tempted to

jump in. I will just ask questions of the three panelists, but I do

want to give you the opportunity to come back to the panel here

and respond to anything that you have heard. We like everything

out on the record, and again I thank you for being here. Let me

just focus on the three of you a second and then we will conclude.

Dr. Albanese, I would like you to give me examples of the Ranch

Hand study of how the hierarchical structure of the military organization can compromise the work. Tell me how it becomes compromised, in your judgment?

Dr. ALBANESE. I’m not going to give you a hypothesis. I’m going

to report on what happened.

Perhaps the most overt effect was a letter from Commander

Mosher who wrote in the name of the Surgeon General Chesney.

And in the mortality report we were directed to use five controls

for every exposed Ranch Hand instead of the 8 to 10 that we had

available. We were to put that as a secondary analysis.

Mr. SHAYS. You would do that based on what? On someone’s directive?

Dr. ALBANESE. Surgeon General Chesney perceived that to be in

the peer-review’s interest. We had no way of verifying that. And I

want to remind you that this was an improperly constituted peerreview at that time. There were no scientists representing veterans.

So we received this letter saying highlight the one to five analysis, not the stronger, more powerful statistical one to eight analysis. And report percentages, mortality percentages rather than

numbers.

Now I was the lead statistician at the time. My desire was to go

with the strongest statistical analysis, one to eight, and feature

that. I felt that there were some indications of a mortality blip.

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And furthermore, when men and women are young, in their 40’s

and early 50’s, percentages are small. But numbers are people,

numbers are real. And the thing to do is actually publish both.

General Chesney intervened directly and changed our report.

Now we have a very small sample size. Very small. A 1 in 1,000

disease is not a rare disease, as the GAO claimed. That’s like leukemia and I wouldn’t view leukemia as a rare disease. If we have

1 in 1,000 extra leukemias, we have 25,000 of them in the Vietnam

veterans. Ranch Hand can’t detect 1 in 1,000. It can’t detect 2 in

1,000 excesses. These are the limitations that haven’t been described.

So how can you amplify the size of the study? You can understand how dioxin affects the metabolism. You can augment your

analysis with models of the toxicology. Now that’s what I was doing

as a statistician. And there’s a letter in the record, which the GAO

has, which absolutely terminates that line of research, written by

Commander Mosher.

Mr. SHAYS. Let me ask you, though, it sounds to me that you

were making a determination that you were going to go beyond the

size of the study. Was that your prerogative?

Dr. ALBANESE. No, no, I was going to augment.

Mr. SHAYS. Now in your judgment, that is your professional license to be able to do that?

Dr. ALBANESE. No, that was part of the protocol, sir, to use toxicological data. I wrote that protocol and that protocol says—with

Moynahan, Lathrop and Wolfe. And that protocol says we were

going to look at the relationship of Agent Orange to disease. Not

dioxin, Agent Orange to disease.

And we were going to look at the Vietnam experience. There are

two other aspects of the protocol that haven’t been fulfilled. There’s

an entire time in-country analysis that has not been featured in

any publication that I’ve been able to time. And there’s been a second analysis. I was just fulfilling the protocol.

Mr. SHAYS. I hear you. Thank you.

Dr. Schwartz, would you expand on your testimony that results

of the Ranch Hand study are used to determine health effects on

all Vietnam veterans, especially women?

Ms. SCHWARTZ. The statement is that it does not, it should not

be applicable to all veterans because, first of all, there aren’t any

women and that’s not the Ranch Handers fault nor the Air Force’s

fault. Women just weren’t in that.

Mr. SHAYS. Thank goodness. Thank goodness that they were not

part of Ranch Hand.

Ms. SCHWARTZ. But I think some of the recent findings about the

levels of dioxin in the soil of our bases really casts another challenge to us about what happened to the folks that were on those

bases, and there were women.

There has not been, to this date, a health study of the women

who served in Vietnam. My own dissertation, it was the beginning.

And the reproductive outcomes has been done by the VA. But what

I am saying is this, that I have heard Dr. Michalek say, and I understand perfectly, that this study was about Air Force Ranch

Handers and that’s the way we should look at it.

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And perhaps it has been too convenient to lean on the results of

this study, to cast the wide net and say that this involves all of the

veterans who served in Vietnam.

Mr. SHAYS. Just based on that comment, do you think that the

study should continue? One, should the study continue? And second, should it continue in the Air Force’s hands? Should it be given

independently?

Ms. SCHWARTZ. This is a hard question but I feel that if we put

it in the correct perspective, that the work that Dr. Michalek and

all the others have done, that this is probably the longest longitudinal picture we have of men who were in the military and the

after effects. If we want at that and looked at that as a way in

which we could use the data which has already been collected, then

I say yes, the study should be continued.

But for us to continue to hang our hat on the fact that this is

the absolute gold standard of what is happening to the health of

veterans who served in Vietnam, no.

Mr. SHAYS. Do you think it being held up as the gold standard?

Ms. SCHWARTZ. Yes, it is. I think that when the National Academy of Science reviews, even though they do mention in their reports some of the things about Ranch Hand’s protocol and study design, that if it’s not statistically significant, Ranch Hand does not

publish it. Therefore, we are not getting all of the information.

If Ranch Hand is publishing, crafting their reports to fit into professional journals, then we are not seeing the things that probably

are greater than a 50 percent chance. So we are denying veterans,

or maybe we are denying veterans some compensation and disability for the facts that we have not really looked at all.

And also, I think the thing is that the subjects who have participated in the Ranch Hand study deserve, deserve to know if there

is anything else. Dr. Albanese raised an excellent point, that the

study is of herbicides. There were 15 herbicides used in Vietnam.

Agent Orange was one of them.

Mr. SHAYS. Thank you. Dr. Trewyn, if you were to take the study

out of the hands of the Air Force, the DOD, who would you give

it to?

Mr. TREWYN. I’m not sure that I would take this study out of the

hands of the Air Force, to be honest. During the 4 years I was on

the advisory committee, I found the personnel involved to be very

responsive to any questions, any materials that we asked for. In

their reports they use a number of different statistical models,

some of which provide useful information, more useful information

for making some of the determinations that this group is interested

in here, the health things that may not sustain the scientific scrutiny that a publication in a peer-review journal would.

But those things are in the report. And I think the material is

there.

Dioxin, and some of the associations that they’re finding with

that, truthfully it’s—well, it’s not found in chemical processes like

it used to be. There is an environmental burden of dioxin that we

all have to deal with. I used to live in Columbus, OH and if you

were anywhere near the trash-burning power plant there, your

dioxin levels were going to be very high because they were putting

a lot of it out the stack. And that was not that many years ago.

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So there are sources of dioxin. I think as a study of effects of

dioxin, granted this is a herbicide study and the data is there for

that. There’s going to be valuable information that’s going to come

out of this. But negative findings in this study mean nothing for

any other Vietnam veteran because of all of these other possible

routes of exposure, other things involved in everything.

And so this really should not be held up for a cure-all thing,

solve-all answer for Vietnam veterans. This isn’t the study to do

that. And I believe at the time they started it, the belief was that

it was going to be. It hasn’t turned out that way and I don’t think

it’s necessarily through the fault of the people involved.

New studies I would put elsewhere.

Mr. SHAYS. Your analogy of the forest and the trees, and the description that a lot of the trees are dying, it implies that even if

we cannot identify the cause to Agent Orange, we know that there

are sick veterans who need help.

Do the other two of you agree with that analogy? Are the trees

dying?

Ms. SCHWARTZ. I would just like to say that the fact that we have

not been able to come to conclusions about the rare diseases and

the cancers that are suffered by the veterans, about the birth defects that they are seeing in their children and their grandchildren

is a great sorrow. It’s a great sorrow.

But the fact is that the lag time between the exposure to Agent

Orange and the appearance of symptoms is upon us now. And I

have buried too many friends in the last few years, women especially, who had never even thought that they had been exposed to

Agent Orange. But I will tell you this, that the only comfort they

got about hearing that their diseases might be related to Agent Orange is the fact that they could consider that they were dying for

their country.

Mr. SHAYS. That is a pretty powerful statement. My general feeling is if I were to ask the VA, they would tell me, and I would be

happy to have them disagree, but they would tell me that it has

not been established that more people are dying who served in

Vietnam.

Mr. TREWYN. I would agree with that, that it has not been established. And that’s one of the flaws in the system. That’s the study,

long-term studies of outcomes, morbidity and mortality, are the

sorts of things, tracking a group of individuals who were involved

in the conflict. And so I’m using this in terms of Vietnam, Persian

Gulf, Kosovo, wherever. Tracking the long-term outcomes to a normal population, a group that was not subject to the same levels of

exposure——

Mr. SHAYS. You have made your case, I think clearly, that to

compare our soldiers who fought in Vietnam who may not have had

direct contact with Agent Orange to those who had direct contact

would be flawed, because they would have indirect contact.

But it would seem to me, and I do want to complete here, but

from my simple-minded approach to this, I would want to determine are more people dying who served in Vietnam, are more people suffering illness and birth defects. I would want to know that

kind of information, and whether or not we knew the exact cause—

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I mean, obviously we want to know the cause for cures and so on.

But at least we could reach out and lend a helping hand to them.

And I would make an assumption that some would have gotten

this illness for other reasons or died for other reasons. But so

what? We gave them additional help. They did serve in Vietnam.

That is kind of the way my simple mind works.

If you all can help steer me in that direction, I would love some

help.

Dr. ALBANESE. May I respond to your first question? I think it’s

beyond a reasonable doubt that there is a birth defects excess in

the Ranch Hand group. I think the preponderance of the evidence

is that there has been an excess of cancer. I think it’s beyond a reasonable doubt that there are some neurological effects. And I think

there’s a preponderance of the evidence that there are

endocrinological effects in the Ranch Hand group.

Having said that, the issue of how these extrapolate or if they

extrapolate to the veterans as a whole is an open and interesting

question.

Ms. SCHWARTZ. I would just like to address that. In my particular study we had three groups. We had women who served in Vietnam. We had women who were in the military but never served in

Vietnam. And we had a cohort of civilian women who were

matched for age and occupation, being nurses. I find that that design has a lot of strengths to it, because you are then able to see,

because there are other exposures to dioxin now in our atmosphere.

My data came from the National Vietnam Veterans Readjustment Study, which was commissioned by the Congress to look at

the readjustment problems of Vietnam veterans. I know that there

has been several proposals that we go revisit this same group that

we studied in 1985, because you have the three groups and you can

see where they are now.

Mr. SHAYS. Dr. Michalek, would you like to make any comments?

Dr. MICHALEK. Just a couple of things. They are fairly technical

and I feel inadequate to respond to some of the statements

that——

Mr. SHAYS. Let me just say this to you, I am not suggesting that

you have the burden of responding to every testimony here. So if

something is said here and you have not responded, I will not assume your silence means you agree.

Dr. MICHALEK. Thank you. I just feel sorry and sorrowful myself,

after listening to Linda talk, and I hate to talk technicalities after

hearing her statements.

Mr. SHAYS. I understand.

Dr. MICHALEK. In the area of mortality, we mentioned the one

to five and the one to eight design. You should know that those

analyses were carried out many different ways and in duplicate in

many of our reports. For example, in 1987, we used a reduced mortality cohort and then we used all mortality study subjects, up to

19,000. And we showed the results side-by-side.

In fact, every step of the way in this study, whenever we’ve

changed our models or changed our ideas about statistics, we do everything twice or three or four times. And so everything is there,

it just takes time to find it.

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In the area of data release, yes, we have released the birth defect

data and I’m sorry about its format. That has to do with NTIS and

the way they handle data and we’ll certainly fix that with CDROMs. With anybody who would approach me for that, I’d certainly

hand it out right away.

On the birth defect issue, as we’ve said, we have the most comprehensive data available. It’s been analyzed independently by the

Centers for Disease Control, and that led to the published article

in 1995. That conclusions in that article were drawn by the Birth

Defects and Developmental Disabilities Branch at CDC. They received the data from us, they interpreted it, and they wrote the

conclusions to that paper.

So what you’re seeing here today is a disagreement between

medical doctors on how to interpret data. That would be Dr.

Albanese against the physicians at CDC. The data is now available

and I would encourage anyone who has any ideas on reanalyzing

that to go ahead. And if you need extra help, call me and I’ll send

you what you need.

Mr. SHAYS. Thank you. Thank you very much.

Good things can happen from the effort of the GAO and there

will be some blessings in this and there will be some silver lining.

And I think when you have devoted as much of your life, Doctor,

as you have, it is tough to have this kind of dialog. I am sure we

could have witnesses that would say things are not exactly this

way, so I understand we can also do it that way.

But I think we are all people of good will and I am absolutely

convinced that you care as much as anyone else about the welfare

of our veterans.

So I thank all of you. You all have made a contribution here.

Let me just allow anyone to make a completing comment if they

want.

Dr. ALBANESE. One concluding comment would be, I believe,

since you are the Government Reform Committee, that a reform is

needed in the Air Force with respect to medical research. Medical

researchers need the opportunity to compete in the open literature

without having a policy review on their papers.

Mr. SHAYS. I think that is fair. Dr. Schwartz?

Ms. SCHWARTZ. I would just reiterate that as the technology of

the battlefield becomes more complex and that the idea that VA

may have to look at compensation, that the military may have to

validate or not validate what’s going on with their soldiers that

they send to war, that thought should be given to a freestanding

institute of military medicine.

Mr. SHAYS. Very good, thank you. Dr. Trewyn.

Mr. TREWYN. I would just say that I do think that in the future,

using the existing sort of NIH peer-review process, a lot of these

studies could be done long-term in a mechanism involving the medical schools and experts around the country to do this. And I do

think that the Congress can have an impact on some of these existing studies.

Because Congress did not mandate, in the Chemical Corps study

and the National Academy did not mandate in that study that

there be a non-chemically exposed group included, a normal control

baseline, there is no normal control baseline. There are Chemical

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Corps workers in Vietnam compared to Chemical Corps workers in

other parts of the world. So you don’t have, you have probably already set the baseline too high.

And there are other studies out there. The old Vietnam Experience study, whether there are things that could be—if that could

be pulled back in and analyzed and the group studied at this point

to see if there are now significant difference, could be an important

thing to do.

Mr. SHAYS. Thank you. I appreciate the VA still having representatives here. Dr. Mather, do you have any, or anyone else? Or

are we all set?

Ms. MATHER. Only that I would hate for people to go away from

the hearing feeling that VA doesn’t do anything for Vietnam veterans who don’t have service connection. In fact, Vietnam veterans

who think their illnesses are due to exposures or service in Vietnam can get treatment in VA hospitals, and they have a priority

for that.

Mr. SHAYS. Dr. Michalek?

Dr. MICHALEK. Just one more thing. I think one thing that we’ve

all heard today, and we’ve said many times, is the committee itself,

the advisory committee, I wish you could find funding to strengthen the committee, to make it proactive instead of reactive, and to

encourage more frequent meetings.

Mr. SHAYS. I honestly think if they had been more proactive,

they would have been a help to you rather than a hindrance, because they would have been coming from the perspective that

would be important. I think that that will be one of the findings

of this committee, and we will try to come out soon with that, and

you have made some suggestions on how we proceed.

So we have learned a lot and you have all been very helpful. I

thank you so much. I have to run off to a budget hearing, so I will

just say thank you.

This hearing is closed.

[Whereupon, at 1:37 p.m., the subcommittee was adjourned.]

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