U.S. GOVERNMENT PRINTING OFFICE

65–548 CC WASHINGTON : 2000

THE PERSIAN GULF VETERANS ACT OF 1998

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

FIRST SESSION

APRIL 22, 1999

Serial No. 106–129

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

JOHN T. DOOLITTLE, California

HELEN CHENOWETH, Idaho

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

CARLA J. MARTIN, 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, 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

SAMANTHA SHERMAN, Professional Staff Member

JONATHAN WHARTON, Clerk

MICHAEL YEAGER, Minority Professional Staff Member

(III)

C O N T E N T S

Page

Hearing held on April 21, 1999 .............................................................................. 1

Statement of:

Byrd, Robert C., a U.S. Senator from the State of West Virginia ................ 7

Mather, Dr. Susan, Chief Public Health and Environmental Hazards

Officer, Department of Veterans Affairs; Dr. Frances Murphy, Chief

Consultant, Occupational and Environmental Health; John Thompson,

Deputy General Counsel; Robert Epley, Director, Compensation and

Benefits; Susan Stoiber, Executive Officer, Institute of Medicine; Dr.

Carolyn Fulco; and Dr. David Tollerud ....................................................... 15

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

Byrd, Robert C., a U.S. Senator from the State of West Virginia, prepared

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

Mather, Dr. Susan, Chief Public Health and Environmental Hazards

Officer, Department of Veterans Affairs, prepared statement of .............. 20

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

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

Stoiber, Susan, Executive Officer, Institute of Medicine, prepared statement of ........................................................................................................... 29

Tollerud, Dr. David, prepared statement of ................................................... 40

(1)

THE PERSIAN GULF VETERANS ACT OF 1998

THURSDAY, APRIL 22, 1999

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 2 p.m., in room

2247, Rayburn House Office Building, Christopher Shays (chairman of the subcommittee) presiding.

Present: Representatives Wise, Sanders, and Schakowsky.

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

Newman, Wharton, Raphael, and Gosa.

Mr. SHAYS. I would like to call this hearing to order and to welcome Senator Byrd. Senator Byrd, I am just going to read a very

short statement. Then we are going to get right to you.

Last month, witnesses from national veterans service organizations urged this subcommittee to keep close watch on the Department of Veterans Affairs [VA] as the Secretary and his staff implement new statutory mandates to meet the needs of sick Gulf war

veterans. Today we heed their advice.

Legislation enacted in 1998 contains clear directives and fixed

deadlines to create a presumption in favor of those seeking to connect toxic war exposures to chronic health effects. But veterans’ advocates warned that bureaucratic resistance and scientific uncertainty threatened more delays in their 9-year struggle for recognition their illnesses are real, their wounds war-related. They were

right.

Under the Persian Gulf War Veterans Act of 1998, April 21,

1999, yesterday, was the deadline for submission of an interim report from the National Academy of Science [NAS] to VA on the toxins to be studied for links to illnesses. But because VA waited 3

months for the Department of Justice to interpret overlapping but

by no means contradictory provisions of two statutes, that deadline

has already been missed.

The good news: VA contracted with NAS in late 1997 for a study

of exposure-related illnesses that may meet most, but not all, the

requirements of the laws. This hearing is to determine more precisely, and more publicly, how the VA and NAS plan to go forward

to meet the spirit, if not always the letter, of the statutes.

The process we oversee today is the culmination of a 3-year effort

by this subcommittee. We held 13 hearings and adopted a report

containing 18 specific recommendations, the first two of which were

that: Congress should enact a Gulf war toxic exposure act estabVerDate 11-MAY-2000 11:36 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\65548.TXT HGOVREF1 PsN: HGOVREF1
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lishing the presumption, as a matter of law, that veterans were exposed to hazardous materials known to have been present in the

Gulf war theater; and the VA should contract with an independent

scientific body composed of non-government scientific experts for

the purposes of identifying those diseases and illnesses associated

in peer-reviewed literature with singular, sustained or combined

exposures to the hazardous materials to which Gulf war veterans

are presumed to have been exposed.

We are very honored to be joined this morning by the author of

the Persian Gulf War Veterans Act, Senator Robert Byrd of West

Virginia. While this subcommittee’s hearings and recommendations

may have helped keep the cause alive, it was his vision and determination, and that of his staff that, in the end, enacted them and

put the law on the side of the sick Gulf war veteran.

Mr. Byrd, we welcome you. We welcome all our witnesses. I ask

if Mr. Wise has any comment that he would like to make and obviously welcome him to this hearing.

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

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Mr. WISE. Thank you Mr. Chairman. Mr. Chairman, thank you

for conducting this hearing. You have been one of the leaders as

well in this fight for the Persian Gulf war veterans. I just wanted

to say, Mr. Chairman that it is a privilege to be able to participate

in the same hearing with Senator Byrd.

Senator Byrd knows well that our State of West Virginia has historically the highest number of veterans per capita. It has for

many, many years. West Virginians, as well as those across the

country always answer the call. When word first began to develop,

and symptoms and problems began to develop, Senator Byrd cut

through a lot of the talk about what could be done and got something done.

We are delighted now to have the Senator here, and also to find

out what it is that needs to be done to make the promise of the

Congress into reality. Thank you very much.

Mr. SHAYS. Senator Byrd, I am just going to get two bookkeeping

things out of the way. I would first ask unanimous consent that all

members of this subcommittee be permitted to place an opening

statement into the record and that the record will 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 statement in the record. Without objection;

so ordered. Senator, I know that Senators are legendary for having

quite a lot to say. With no reluctance at all, we do not have a clock

for you. You are welcome to speak as long as you would like.

STATEMENT OF ROBERT C. BYRD, A U.S. SENATOR FROM THE

STATE OF WEST VIRGINIA

Senator BYRD. Mr. Chairman, I appreciate that consideration. I

thank you for inviting my comments on the implementation of the

Persian Gulf War Veterans Act of 1998. I am extremely grateful for

the opportunity to appear before this committee today. I am especially happy to see my colleague, Robert Wise, here as well.

I think of Bob Wise sometimes as a steam engine in britches. He

is so blessed with energy and drive. He is a very hard worker for

his District. I am sure he works well with his colleagues here. I

consider it a privilege to have the opportunity to be introduced by

him.

Chairman Shays, I have especially enjoyed the way that you and

I have been able to work across a sometimes deep divide that can

separate our Houses and our parties in order to do what is right

and long over-due for the veterans of the Persian Gulf war. Concern for our Nation’s veterans should be non-partisan in the sense

of political parties, but wholly and completely partisan in our

hearts.

Today as we watch daily reports of bombing runs over Yugoslavia, it is easy to recall the eerie precision of the video war that

was Operation Desert Storm. Many Americans’ initial impression

of Desert Storm was of a technically precise, almost bloodless operation in which bombs dove to their targets with such deadly accuracy that Iraq’s much feared military might seemed to evaporate

before our eyes.

As allied pilots assailed Iraq’s chemical and biological warfare industry, military planners crowed that Iraqi military commanders

8

could not bring themselves to use the weapons that we had feared

most, the chemical and biological warfare agents that we suspected

Iraq of possessing.

Chemical alarms blared incessantly. To protect troops, vaccines

unproved for military use were employed and other preventative

medical measures were widely taken. To combat disease, pesticides

and repellents were sprayed, adding to the foul smog created by

burning oil wells set alight by retreating Iraqi forces.

Soldiers quite literally operated in a fog of war for weeks on end.

In retrospect, it is hardly surprising that so many veterans of the

Gulf war have been in ill health as the result of their service. The

official response has been slow; slow to recognize the prevalence of

illness; slow to react; slow to organize; slow to respond.

Until the admission in June 1997 that United States forces had

in March 1991 blown up large amounts of Iraqi chemical warfare

agents at more than one site, no serious effort has been made to

investigate the role that exposure to chemical or biological warfare

agents may have played in injuring soldiers’ health.

The Persian Gulf Veterans Act of 1998 attempts to make up for

lost time by requiring the National Academy of Sciences [NAS] to

review exposure to many potential hazardous agents during the

war and determine what illnesses may be linked to those exposures.

The NAS is also required to recommend further studies where

needed in order to resolve questions. With the NAS study in hand,

the Persian Gulf War Veterans Act gives the Secretary of Veterans

Affairs the ability to administratively make a determination that

the illness is service connected for the purposes of providing health

care and benefits to the affected veterans.

The most critical element of the Persian Gulf War Veterans Act

is that no intervening act of Congress is required to make a determination of service connection happen. I know that I am preaching

to the choir here when I observe that requiring an act of Congress

to make something happen in a timely manner is perhaps more difficult than requiring an act of God to happen.

I am far more confident, far more confident, that any Secretary

of Veterans Affairs will exercise undue restraint than I am, that

he or she will be excessively generous in making such a determination of service connection.

I can only urge this and all future Secretaries of Veterans Affairs

to act in a just and reasonable manner, ensuring that, to paraphrase President Theodore Roosevelt, veterans get a square deal.

I am getting a bit ahead of myself, however. Before those determinations can be made, the reviews have to be conducted.

The first deadline in the act requires the Secretary to seek to

enter into an agreement with the NAS not later than 2 months

after the date of enactment of this act. That would have been December 21st, Chairman Shays, 1998. However, the VA delayed,

seeking a legal opinion from the Justice Department that was received on March 12, 1999.

It basically told the VA to proceed. The second deadline in the

act called for an interim report from the NAS specifying the agents,

the hazards, the medicines, and vaccines to be considered. That reVerDate 11-MAY-2000 11:36 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCS\65548.TXT HGOVREF1 PsN: HGOVREF1
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port should have been delivered on April 21st, which was yesterday, 6 months after the date of enactment.

The next and first full report should be delivered on April 21st

of next year, with the Secretary’s determination of service connection made by June 21, 2000. Even if lost time is made up, no veteran will receive any benefit from this act before November 21,

2000—10 years, 3 months, and 20 days after Iraq invaded Kuwait.

I know that the intent of this hearing is to press the Department

of Veterans Affairs to move out swiftly to implement this act. I applaud you for your diligence in conducting this kind of oversight.

On the other side of the Capitol, I have joined the subcommittee

on VA, HUD, and Independent Agencies of the Senate Committee

on Appropriations in order to better oversee the implementation of

this and other programs designed to help our Nation’s veterans.

Together, then, we can maintain the same vigilant defense of our

Nation’s veterans that they have provided to us for so long and so

well. So, I thank you again for this opportunity to testify, Mr.

Chairman. Thank you and all of the members of the committee.

[The prepared statement of Hon. Robert C. Byrd follows:]

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Mr. SHAYS. Senator Byrd, thank you for your willingness to come

today and for your very strong statement. Also, thank you for not

just putting this legislation in and then doing the next good deed,

but making sure that the intent of the legislation is fulfilled.

Thank you as well for serving on that subcommittee to be a little

bit more of an oversight directly with the VA, which will be extraordinarily helpful.

Senator BYRD. Thank you.

Mr. SHAYS. We are joined by Bernard Sanders who has been

frankly as strong as any member on this subcommittee in focusing

on this issue. I welcome him as well. I do not have any questions

to ask you, Senator. I do not know if either of my colleagues would

like to make a comment or ask a question.

Mr. SANDERS. I just want to echo your thoughts, Senator Byrd.

We knew at the end of this last session when this legislation was

somewhat up in the air, you played a very important and pivotal

role in making sure that it got through. We appreciate that very

much. I agree with you.

After all of these years, these Gulf war veterans deserve a fair

shake and you helped make it happen. We are very appreciative for

your efforts.

Senator BYRD. Thank you, sir. Let me thank on the record my

very able assistant, Lisa Tuite, who is here seated just behind me.

She followed that legislation through its journey, even into the conference. I cannot over-estimate or over-state the contribution that

she made in the enactment of that legislation. I thank you, Mr.

Sanders.

Mr. SHAYS. Thank you. Bob, any closing comment?

Mr. WISE. Simply just thank you very much, Senator, for coming

and making us aware, and prompting all of us to make sure that

this legislation is implemented as enacted.

Senator BYRD. Thank you. Mr. Chairman, I served in the House

47 years ago. You did not have this beautiful building then. I first

served in the House when Speaker Martin, a Republican from Massachusetts I believe.

Mr. SHAYS. So, is it a little nostalgic or are you just happy not

to be here?

Senator BYRD. I started in the Longworth Building, I believe it

was and then the Cannon Building. This building was I guess, not

even in the plans, but it is a beautiful building. I congratulate you

on having such a beautiful edifice in which to serve.

Mr. SHAYS. Senator, thank you again for being here. It has really

been a pleasure. You have honored our committee and thank you.

Senator BYRD. Thank you. Thank you very much.

Mr. SHAYS. We are going to have our second panel.

We welcome Dr. Susan Mather, Chief Public Health and Environmental Hazards Officer, Department of Veterans Affairs. I only

hesitated a bit because I went to Mather Junior High School. It is

spelled the same way.

She is accompanied by Dr. Frances Murphy, Mr. John Thompson,

and Mr. Robert Epley. Our second testimony will be from Susan

Stoiber, Executive Officer, Institute of Medicine. She is accompanied by Dr. Carolyn Fulco. Also, our third testimony is from

David Tollerud, professor.

14

We welcome all testimony, as well as those witnesses who are accompanying those who are giving testimony.

[Pause]

Mr. SHAYS. While we are setting up the cards and so on, I would

just preface your testimony by saying that this is not a hearing on

whether there are Gulf war illnesses or not. It is really a hearing

on getting a sense of where the VA and you all are in terms of following the legislation that is passed.

I do not anticipate that this has to be a particularly long hearing.

We just want to be monitoring what is happening. We want to

know what your thoughts are about how you implement the legislation.

Now, some of the people who are accompanying, are they just sitting behind? What I will do is, I would like everyone whose name

I called—are we missing some people here? Now, I read seven people off and I see five. Are two sitting behind?

Dr. MATHER. Dr. Tollerud is on his way from Philadelphia.

Mr. SHAYS. OK. We will have to swear him in separately then.

If I could invite you all to stand. Let me just say that we did not

swear in Senator Byrd because he was giving a statement and we

were not going to ask him questions, but we swear in all of our witnesses. Thank you very much.

Do you solemnly swear or affirm that the testimony you will give

before this subcommittee will be the truth, the whole truth, and

nothing but the truth?

[Chorus of ayes.]

Mr. SHAYS. Thank you very much.

For what it is worth, I would just like to tell you that my state

of mind is one, that this is a new year. I am just interested in getting this legislation moving forward. So, I am not as focused as to

why it has taken us to this point to get here, but just really what

do we do from here to move forward. You are welcome to talk about

anything you want.

We are going to have the 5-minute clock, but we are going to roll

it over. Hopefully within 10 we can cover what each of you want.

I do not want any of you to leave today if you did not say something that you felt needed to be said.

So, I will tell you that you will be able to end if you did not have

it in your testimony and we did not ask the question; have you

make sure to make it a part of the record. All set.

Mr. SANDERS. Do you want to do opening statements?

Mr. SHAYS. We did opening statements before, but if you have an

opening statement you would like to give, I would welcome it.

Mr. SANDERS. Yes. Let me make a brief opening.

Mr. SHAYS. That is fine.

Mr. SANDERS. Thank you for holding this important hearing. We

have worked hard on this issue. I think we are making some

progress. Today’s hearing is very important to make sure that we

continue to go forward. As all of you know, last year at the end of

the last sessions, Chairman Shays and myself, along with 211 others in a bipartisan way introduced the Persian Gulf War Veterans

Health Act of 1998.

The bill would have established in law a presumption of service

connection for illnesses associated with exposure to toxins present

15

in the war. The VA’s Secretary, under the proposed legislation,

would be required to accept the findings of an independent scientific body as to the illness’ link with actual and presumed toxic

exposures.

By establishing a rebuttal presumption of exposure, and the presumption of service connection to exposure affects, the bill places

the burden of proof on the VA where it belongs and not on the sick

veteran. That is precisely what we wanted to do and that is important. Senator Byrd introduced a similar bill in the Senate.

As we all know, this bill was then concluded in the Omnibus Appropriations bill and was enacted into law in October 1998. The

presumption of exposure law is critical for our Gulf war veterans

as it requires that they be provided medical care for Gulf war illness, as well as disability benefits for any illness that they may

have received as a result of toxic exposure in the Gulf.

The law mentions 31 specific ‘‘biological, chemical, or other toxic

agents, environmental, or wartime hazards, or preventative medicines, or vaccines to which members of the Armed Forces who

served in the theater of operations during the Persian Gulf war

may have been exposed.’’

We are here today to determine if the VA and the National Academy of Sciences have been doing their work. According to the law

passed last October, the NAS should be delivering an interim report on the review and evaluation of the 31 toxic agents, environmental, or wartime hazards, or preventative medicines, or vaccines

associated with Gulf war service that were enumerated in the legislation. Of course, the NAS cannot accomplish its duties without the

cooperation of the VA.

So, we are here to see if that cooperation is taking place and if

not why not and where do we go from here. The interim NAS report is the first step in the process of diagnosing the treating of

Gulf war veterans. As I have said, this has been a long time coming.

Some of us are very mindful of what happened to Vietnam veterans with regard to Agent Orange. We are very determined, very determined not to see that happen again. Mr. Chairman, I look forward to hearing our first report from the VA on the implementation of this very important new piece of legislation that you were

so active in getting passed. Thank you.

Mr. SHAYS. Thank you Mr. Sanders. Thank you very much. This

is a team effort; hopefully a bigger team here. Dr. Mather, we welcome you. Thank you.

STATEMENTS OF DR. SUSAN MATHER, CHIEF PUBLIC HEALTH

AND ENVIRONMENTAL HAZARDS OFFICER, DEPARTMENT OF

VETERANS AFFAIRS; DR. FRANCES MURPHY, CHIEF CONSULTANT, OCCUPATIONAL AND ENVIRONMENTAL HEALTH;

JOHN THOMPSON, DEPUTY GENERAL COUNSEL; ROBERT

EPLEY, DIRECTOR, COMPENSATION AND BENEFITS; SUSAN

STOIBER, EXECUTIVE OFFICER, INSTITUTE OF MEDICINE;

DR. CAROLYN FULCO; AND DR. DAVID TOLLERUD

Dr. MATHER. Thank you. Mr. Chairman and members of this

subcommittee, it is a pleasure to appear before you to describe and

discuss implementation of the Persian Gulf War Veterans Act of

16

1998, which was enacted on October 21, 1998 as a part of the Omnibus consolidated appropriations legislation.

Accompanying me today are Mr. John Thompson, Deputy General Counsel; Dr. Frances Murphy, Chief Consultant, Occupational

and Environmental Health; and Mr. Bob Epley, Director of the

Compensation and Pension Service. Although the letter inviting us

today refers to VA’s implementation of the Persian Gulf War Veterans Act of 1998, VA is also charged with simultaneously implementing the provisions of Section 101 of the Veterans Program Enhancement Act of 1998, which established an overlapping frame

work for addressing issues related to the health status of Persian

Gulf veterans.

Thus, our implementation of the former statute must take into

account our responsibilities under the later. The Program Enhancement Act was passed by the House of Representatives on October

10, 1998 and subsequently passed without amendment by the Senate and cleared for the President on October 21, 1998.

Passage by the Senate occurred only hours after its final action

on an Omnibus appropriation measure, which included the Gulf

War Veterans Act provisions based on the adoption of an amendment offered by Senator Byrd. The Omnibus appropriation measure was signed into law that day. The Program Enhancement Act

was signed into law on Veterans Day, November 11, 1998.

Thus, VA was presented with the unusual situation of interpreting and implementing two similar purpose acts that were passed

within hours of each other. Although similar in purpose, there are

several instances in which these measures take seemingly inconsistent approaches to the study of health risks associated with

service in the Gulf war and the provision of compensation to veterans who may have incurred disability as a result of Gulf war service.

In addition, the Gulf War Veterans Act contains a provision to

nullify Section 101 of the Veterans Program Enhancement Act of

1998 or ‘‘any similar provision of law enacted during the second

session of the 105th Congress requiring an agreement with the National Academy of Sciences regarding an evaluation of health consequences of service in Southwest Asia during the Persian Gulf

War.’’

In view of the inconsistencies in the two statutes and the purported nullification provision in the Gulf War Veterans Act, on December 8, 1998, VA’s General Counsel asked the Department of

Justice’s Office of Legal Counsel for an opinion regarding VA’s implementation of the two statutes.

The Justice Department responded to the General Counsel’s letter on March 12, 1999. In brief, the Justice Department opines at

Section 1604 of the Gulf War Veterans Act is constitutionally invalid and ineffective in so far as it purports to nullify certain described legislation, including Section 101 of the Program Enhancement Act that might be enacted in the future.

The respective provisions of the two laws, although redundant

and burdensome in some respects, if both laws are given effect, are

not inherently conflicting or mutually exclusive. Therefore, the provisions of both laws must be treated as valid and effective.

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With respect to the areas of conflict between the two statutes,

the Justice Department found the most significant variation between the two bills to be the action required to be taken by the

Secretary after receiving a report from the NAS.

Following receipt of the opinion, VA’s General Counsel conducted

an intensive review of the provisions of each statute in order to ensure proper implementation of both statutes by all concerned parties. As a result of this review, the General Counsel has advised

VA’s program officials as to the measures needed to fulfill VA’s duties under the two laws.

I understand that you are particularly interested in the contract

with the NAS, including its status, terms, conditions, and time

lines. I will briefly summarize this information and will be happy

to provide a copy of the full contract to you.

Because of the real concerns and fears of Gulf war veterans and

their families about the health consequences of military service in

the Gulf war, the Under Secretary for Health sent a letter to NAS

on October 31, 1997 requesting that NAS comprehensively review,

evaluate, and summarize the available scientific and medical information regarding the association between exposures during the

Gulf war and adverse health effects experienced by some Gulf war

veterans.

The National Academy of Sciences’ proposal was accepted and

the contract was signed on June 24, 1998, which was 4 months

prior to the enactment of Public Law 105–277. An NAS committee

will provide a comprehensive review, evaluation, and summary of

available scientific and medical information regarding the association between exposures during the Gulf war and adverse health effects experienced by Gulf war veterans.

This review will include an assessment of biologic plausibility

that exposures or synergistic effects of combined exposures are associated with illnesses experienced by Gulf war veterans. The NAS

will make recommendations for additional scientific studies to resolve areas of continued scientific uncertainty related to health consequences.

The total estimated cost of this review is $1,250,000 over a 27-

month period from June 1, 1998 through August 31, 2000. The initial year funding was established at $500,000. The project is being

conducted in three phases. In the initial phase, the NAS is identifying health outcomes of interested and selected exposures to be examined.

Exposures may include, but are not limited to depleted uranium,

pesticides, insecticides, chemical and biological warfare agents, vaccines, pyridostigmine bromide, health stress, solvents, paints, fuels,

smoke from oil well fires, and sand.

A review of the literature regarding some prototypic exposures

and associated health effects is being conducted to develop methods

to be used for analysis and synthesis of different types of research

findings.

For example, animal toxicology data, occupational exposure data,

and epidemiology data. Latency periods between exposures and

manifestation of illnesses will also be assessed.

The analysis will take into account the strength of scientific evidence and the appropriateness of the methods used to identify asVerDate 11-MAY-2000 11:36 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCS\65548.TXT HGOVREF1 PsN: HGOVREF1
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sociation; whether the evidence indicates the levels of exposure

were comparable to the exposures of Gulf war veterans, and whether there exist a plausible biological mechanism or other evidence

for an association.

A report of the activities and finds of the committee will be produced. During phase II the remaining exposures will be subject to

similar review and analysis. Finally, VA will seek to enter into a

contract with NAS for a series of updated reviews to be conducted

every 2 or 3 years. The committee plans to meet 6 or 7 times during the 27 months.

Meetings were held in January and February 1999. The third is

scheduled for April 27th and 28th. A report will be prepared and

issued which describes the framework by which association is to be

determined, criteria by which specific exposures and adverse health

outcomes are to be considered for study, a list of exposures and outcomes to be considered in the first two phases, and language to be

used to categorize the associations under study.

The report will include a literature review of the association between specific health effects and three to six exposures experienced

during Gulf war deployment, and directions for future scientific research to resolve continued scientific uncertainty for the exposures

assessed within the report. The exposures covered in this first report will be chosen to reflect a variety of data sources and methodology problems.

For example, a review of associations which depend most heavily

on biologic plausibility in animal toxicology data will differ from associations dependent upon occupational exposure and populations

other than Gulf war veterans, and from associations dependent on

exposure data and epidemiology data from Gulf war veterans.

Because this effort predated the enactment of Public Law 105–

277, it does not conform precisely to the legislative language. The

study has been designed by the NAS to be of high scientific merit

and to be completed in the shortest timeframe deemed feasible.

Therefore, we feel that it fully meets the intent of Public Law 105–

277 and the similar Public Law 105–368. More importantly, this

study will provide a thorough review of the scientific literature by

an expert committee. Their conclusions are of utmost importance

because they will form the basis for compensation decisions.

We are certain that the current contract sets out the minimum

time required to provide a high quality, comprehensive literature

review. This genuine effort responds to the concerns of Gulf war

veterans and their families and the intent of Public Law 105–277.

The Persian Gulf Veterans Act of 1998 also asked VA to enter into

an agreement with the NAS to review and identify empirically

valid models of treatment for various chronic illnesses that employ

success treatment modalities for populations with similar symptoms.

Under this review the NAS would make recommendations for additional scientific studies and treatment trials. In 1998 VA contracted with the NAS to provide advice on the optimal methods to

assess the health status of Gulf war veterans and the effectiveness

of treatments being delivered by the Department. The NAS will

complete this project in June 1999. After the final report is comVerDate 11-MAY-2000 11:36 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 C:\DOCS\65548.TXT HGOVREF1 PsN: HGOVREF1
19

pleted, the committee will continue and expand its study to address

the mandate of Public Law 105–277 concerning treatment models.

I understand that some observers have expressed concerns about

delays in research and the negative impact on medical care and

other benefits and services that Gulf war veterans have earned

through their military service. Please be assured that research efforts and other important efforts on behalf of Gulf war veterans are

continuing uninterrupted. Large numbers of Gulf war veterans are

receiving medical attention from VA. Over 230,000 Gulf war veterans have received health care services at VA facilities. More than

74,000 Gulf war veterans have completed the VA Gulf War Registry Examination Program.

Gulf war veterans with difficult to diagnose illnesses are still

being transferred to our four national Gulf war referral centers for

intensive in-patient examinations and special consultation. Gulf

war veterans with chronic undiagnosed illness, as well as those

with diagnosed service connected illnesses are receiving disability

compensation.

VA has granted claims for service connection for more than

128,000 Gulf war theater veterans have. We are totally committed

to providing the benefits and services to which these veterans are

entitled. Mr. Chairman, we were recently advised of the committee’s interest in the status of the number of Gulf war veterans disability claims for which additional review was determined to be

warranted.

On July 16, 1996 our Compensation and Pension Service mandated a review of all previously disallowed Gulf war disability

claims. The purpose of the review was to assure that all necessary

development had been completed, and to assure that all evidence

had been properly considered in reaching the decision.

At that time, 10,736 claims were developed for readjudication.

The results of that readjudication are as follows: service connected

was granted in 2,802 claims. Compensation for undiagnosed illness

was granted in 1,348 claims. That figure includes 1,044 previously

denied undiagnosed conditions, and 304 newly considered

undiagnosed conditions. Diagnosed conditions were granted service

connection in 1,454 claims. That figure includes 597 previously denied undiagnosed conditions and 857 newly considered diagnosed

conditions. In 5,264 claims there were no changes on review, but

service connection had already been granted for another condition.

In the remaining claims, service connection could not be granted

for any condition and denial of service connection was confirmed.

There are four cases for which action has yet to be completed under

this review. That concludes my statement. My colleagues and I

would be happy to answer any questions that you have.

[The prepared statement of Dr. Mather follows:]

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Mr. SHAYS. Thank you very much, Dr. Mather.

We did not swear in two witnesses. Dr. Tollerud, we need to

swear you in and we also need to swear in Dr. Carolyn Fulco. If

you do not mind standing up and I will administer the oath. Thank

you.

Do you solemnly swear or affirm that the testimony you will give

before this subcommittee will be the truth, the whole truth, and

nothing but the truth?

[Chorus of ayes.]

Mr. SHAYS. Thank you very much. Thank you Dr. Mather. Now,

we will go to Dr. Susanne Stoiber.

Ms. STOIBER. Good afternoon Mr. Chairman. I am Susanne

Stoiber. I am executive officer of the National Academy of Sciences

Institute of Medicine. My colleagues and I are here today to provide testimony and answer questions about the current IOM study

related to the health effects associated with exposures experienced

during the Persian Gulf war, and the IOM contract with the Department of Veterans Affairs, sponsors of that study. I am accompanied today by Dr. David Tollerud who is professor at the School

of Public Health at the Medical College of Pennsylvania, Hahnemann University in Philadelphia. Dr. Tollerud has served on three

Institute of Medicine committees to review the health effects of

Vietnam veterans’ exposure to herbicides. He chaired two of those

committees. Has indicated, also present are two senior IOM colleagues, Carolyn Fulco, Director of the Gulf war study and Dr.

Kathleen Stratton who oversees our general work in this area. My

testimony summarizes the National Academy of Sciences Institute

of Medicine procedures for conducting studies and the history and

status of our current project on the health effects of Persian Gulf

war exposures. I will not repeat that testimony.

The credibility and value of our reports rest on the processes that

we follow to ensure that the work of our committees is independent

and is scientifically rigorous. To that end, we enlist the Nation’s

leading scientists to conduct the studies. These scientists serve

without compensation and do the work for us in addition to their

regular jobs. We protect against bias and conflict of interest and

have very rigorous procedures for ensuring that end.

We require a comprehensive and rigorous review of the evidence.

Following the completion of the committee’s work, we have an

equally difficult, rigorous peer review of the committee’s work by

a second group of leading scientists who mirror the expertise on the

original committee.

This is a time consuming process, and especially so when the

subject is complex and the evidence to be examined extensive. The

resulting reports however provide accurate and conclusive answers.

That is our commitment. We believe that nowhere is this more important than in the work we conduct on behalf of the Nation’s veterans.

The IOM is especially pleased to have the opportunity to work

on studies that shed light on the nature of illnesses experienced by

our country’s veterans. I will now turn to Dr. Tollerud who will

provide more extensive information on the way our study committees have conducted their work on Agent Orange.

28

Our work on Agent Orange provided the model, the blue print for

how we propose to conduct the work on Persian Gulf exposures.

Therefore, I think knowing slightly more detail about how they proceeded and the difficulties they encountered will help in our discussion on how quickly work can be completed on Persian Gulf.

[The prepared statement of Ms. Stoiber follows:]

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Mr. SHAYS. Can I interrupt you? I feel a little guilty taking off

my coat without inviting any of you to do this. It is kind of hot in

here. Please feel welcome to do so.

Dr. TOLLERUD. Good morning, Mr. Chairman, and members of

the committee. My name is David Tollerud. I am a professor in the

school of public health at MCP Hahnemann University in Philadelphia. I also have the unique distinction of having served as co-chair

of the original IOM Committee to review the health effects in Vietnam veterans of exposures to herbicides, and as chair of the two

followup committees.

In total, I have served on these committees for some 8 years. I

appreciate the opportunity to provide testimony to you today based

on my experience from the veterans and Agent Orange studies. I

was requested to provide testimony because the Vietnam veterans

studies are very similar to the Persian Gulf veterans study that is

the subject of this hearing.

The Gulf war committee will use the Veterans and Agent Orange

reports as their model. However, I must point out an important difference between these efforts. The Veterans and Agent Orange

studies examined only one category of exposures: the major herbicides used in Vietnam and the herbicide contaminant dioxin.

Within this category of exposures, the committee focused primarily on a single compound dioxin; more specifically 2378,

tetrachlorodibenzo-p-dioxin, because of the vast number of scientific

studies suggesting adverse health outcomes that might be associated with exposure to it.

Each of the Veterans and Agent Orange studies took approximately 18 months to 2 years to complete. The Gulf war study will

include at least 12 categories of exposures each comprised of multiple chemicals. I am told there are approximate 34 specific chemicals or chemical compounds listed in Section 1603 of Public Law

105–277; a list similar to that specified in the Department of Veteran Affairs contract with the Institute of Medicine.

Given the far larger number of categories of exposure proposed

for the Gulf war study, it is my opinion that the timeframe developed by the IOM and the Department of Veterans Affairs, and delineated to you today by Ms. Stoiber, is reasonable.

I do not believe that the time table stipulated in the Persian Gulf

Veterans Act of 1998, which requires a final report addressing all

12 categories in 18 months would allow an Institute of Medicine

committee to complete its tasks with he scientific rigor and attention to the interest of veterans that this work demands.

In support of these opinions, I would like to relate to you the elements that went into making the Veterans and Agent Orange series of reports and that are proposed for the Persian Gulf veterans

study. Almost all National Academy of Sciences reports are written

by committees of scientists. Committee members are individuals

who serve on a volunteer basis and receive no compensation for

their work.

Assembling a committee for an effort like the Veterans and

Agent Orange studies and this Gulf war study is a time consuming

task because IOM holds the members of its veterans health committees to its highest standards for participation. Committee members must not have any research grants from the Department of

38

Veterans Affairs because in conducting its work the committee

must operate independently of DVA.

They must also have no research or consulting involvement with

businesses that might have an economic stake in matters under the

committee’s consideration. Staff must find scientists who are willing to devote considerable time and energy to a project that is not

directly related to their own research because committee members

must not have had prior direct involvement with the issues before

them, nor have taken a public position on them.

Committee members are thus required to learn and comprehend

a new topic; a process that necessarily takes time. The Veterans

and Agent Orange Committee realized from the beginning that it

could not conduct a credible scientific review without a full understanding of the experiences and perspective of the veterans.

Therefore, to supplement its standard scientific process, the committee opened several of its meetings to the public to allow veterans and other interest individuals to voice their concerns and opinions, to provide personal information about their exposures and associated health effects, and to educate the committee on recent research results and studies still underway.

While it takes time for the committee to gather this type of information, it provides a meaningful backdrop for the numerous scientific articles that the committee reviewed and evaluated. I am

pleased to hear that the IOM proposes to conduct the Gulf war

study in a similar manner. I believe it is important that they be

given the time to do so.

The Veterans and Agent Orange Committee gathered information from multiple sources, always with the goal of seeking the

most accurate information and advice from the widest possible

range of knowledgeable sources.

Consistent with the procedures of the IOM, the committee met

in a series of closed sessions and working group meetings in which

members could freely examine, characterize, and weigh the

strengths and limitations of the vast array of scientific evidence.

In addition to these formal meetings, the committee actively and

continually sought information from a broad array of individuals

and organizations with interest or expertise in assessing the effects

of exposures to herbicides, just as the Gulf war committee has

planned. These interactions include frequent meetings with representatives of veteran service organizations, congressional committees, Federal agencies, and scientific organizations. One of the

many ways the Vietnam Veterans Committee heard from the public was through several hundred telephone calls, letters, and emails, each of which received a response from IOM staff, just as

the Gulf war committee and staff are doing.

This important part of the process takes a great deal of time.

During the course of the first Agent Orange study, which I would

again remind you focused on one exposure, the committee or staff

read approximately 6,400 abstracts of scientific and medical articles which were all entered into a computerized bibliographic data

base.

I am told that the Gulf war committee and its staff have already

reviewed and cataloged over 10,000 abstracts and their work is just

beginning. As time consuming as the beginning efforts are in such

39

studies, the real work is in evaluating the articles, determining the

strength of the findings, and discussing the outcomes among the

committee members.

The value of the iterative and deliberate processes that are the

hallmark of such studies is that the result is a comprehensive, unbiased, scientific review of all of the available evidence regarding

the potential health effects of an exposure. More importantly, the

document that is produced is a consensus of the collective knowledge of that committee. Each committee member is able to defend

the findings, conclusions, and recommendations in the final report

because each has been through a lengthy committee process that

has built a bond of trust among all participants.

In my opinion, it is simply not possible to substantially shorten

the period of time necessary for this confidence to develop. All of

the evidence from multiple sources must ultimately be assembled

into coherent chapters. The draft chapters are discussed, written,

and rewritten multiple times before they accurately reflect the committee’s findings and conclusions.

The chapters must be organized into a document that characterizes the committee’s thinking and conclusions, and represent a consensus of the committee’s collective recommendations. This process

is also iterative and deliberative and represents an additional investment of time.

Finally, the IOM requires an extensive and lengthy peer review

process for the document in order to assure its scientific integrity

and the appropriateness of its conclusions. The review process requires identifying and nominating a panel of external reviewers

who are also volunteers. There is also an internal academy review

committee.

These external and internal reviewers provide feedback which

strengthen and enhances the scientific integrity and effectiveness

of the committee’s product. This independent review is regarded as

an essential safeguard in maintaining a high standard for all academy reports and lends credibility to each approved manuscript.

This process which takes several months to complete is a hallmark that distinguishes the academy from many other organizations offering the Federal Government scientific and technical advice. It is one of the primary reasons that academy reports are

often the final word on issues of importance to the Government and

others.

The review process, like each step in conducting an academy

study, is thoughtful, deliberative, and requires time. I hope I have

been able to provide you with insight into why academy studies of

veterans health issues take time and need to take time, and to lend

support to the time line in the current Department of Veteran Affairs’ contract with the IOM to study the health effects associated

with exposures experienced during the Persian Gulf war.

Thank you for your attention. I will be happy to answer any

questions.

[The prepared statement of Dr. Tollerud follows:]

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Mr. SHAYS. Thank you very much, Doctor. I would just like to

first acknowledge the presence of Janice Schakowsky who is from

Illinois. It is nice to have you here. She is a new Member and a

very effective Member of Congress. I am trying to get a sense of

where we are headed here.

One of the things that I take as given, and I would ask the three

witnesses to respond in the order of their testimony; my general

understanding is that the VA accepts the fact that they have two

mandates of Congress that while having some differences clearly

are not incompatible and that the VA intends to abide by the law

and the language. I guess, Dr. Mather, that is your question.

Dr. MATHER. Yes, sir. That is the case.

Mr. SHAYS. I do not care, given the other things I am interested

in to figure out whether the lawsuit made sense or, excuse me, the

request made sense to the Justice Department or not. It may have

or it may not have. I am less concerned with that. I am more concerned with getting a sense of the effort to live by the spirit of the

law. I wanted to know what that means.

You clearly had a contract the year before to begin this process.

Is there any inability on the part of the VA to renegotiate the contract to try to have it conform as closely as possible to the law?

Dr. MATHER. No, sir. We feel though that the contract that we

have now is a good approach and is the best approach. We certainly agree that the law is firm in the interim report. After the

meeting on the 27th of this month, we expect that there will be a

report from the committee that will talk about where they are so

far.

It will be a brief report. We get quarterly reports on contracts

anyway. I think this would be a reasonable point at which to expect a report. We have already talked informally with the National

Academy about the points of the law which do not appear to be covered in our current contracts and how we can expand those contracts.

I think what we have now is basically a very sound approach to

a very, very complex problem. I think the current contract will

stand, should stand, and will need to be amended to take care of

the other items within the laws.

Mr. SHAYS. If something cannot be done, even if the law requires

it, it will not get done, or if it can get done but it is absurd to try

to do it, then there are some issues that have to be dealt with.

What flexibility does a Department have in deciding, and I am

not even talking the merits of this particular issue, to basically live

by the spirit and not the letter? How does that work? Maybe Mr.

Thompson you could tell me.

Mr. THOMPSON. That is a fascinating question. What we are trying to do is to execute the law as faithfully as we can. Now, if it

appears that there is an area that is just not feasible to do or cannot be done within the time constraints that Congress has ordained, we would attempt to come as close as we can. We would

notify the committees of interest of what difficulties we were having.

Mr. SHAYS. Congress could try to mandate that an elephant can

fly, but it is not going to fly even though I sometimes think the 747

is kind of like that and it does fly. Dr. Tollerud, you make it very

45

clear from your testimony that there is a process that you feel has

to be followed and it is going to take a certain amount of time.

I am going to make an assumption that there is some time you

wanted to take to fit into your schedule and the schedule of everyone else that is involved in this research. There is the schedule

that Congress wants and they conflict. But I make an assumption

that to the best of your ability, if you can speed up a process the

law requires it, you will do it as long as it does not create bad scientific results. Is that a fair assumption?

Dr. TOLLERUD. I guess I would like to have the IOM answer from

their perspective.

Mr. SHAYS. Yes. I think that would be more appropriate.

Dr. TOLLERUD. I will be happy to give you my personal view

based on 8 years of experience.

Mr. SHAYS. Ms. Stoiber, I am sorry. I should have asked you to

do that question.

Ms. STOIBER. That is fine. Our commitment and our interest in

the IOM is in doing this work as rapidly as we can possibly do it

and still produce scientifically valid and complete answers. So, we

actually have spent a substantial amount of time with our Persian

Gulf Committee.

Dr. Tollerud is not on that committee. He was on the Agent Orange Committees; talking about whether or not we could devise a

way to do the work faster, given the large number of exposures to

be considered.

After very extensive discussions with the volunteers who will be

doing the analysis on the Persian Gulf Committee, we concluded

that we really could not figure out a way to speed up the process

and still feel confident that we would be able to deliver accurate

and valid results.

We have given it a great deal of thought. It is not just a matter

of the volunteers trying to fit it in with the rest of their obligations.

There is simply an enormous amount of literature to be absorbed

in this and a need to make sure that we are treating it consistently

across the different exposures. So, our belief is there is not a way

to speed up this particular analysis.

Mr. SHAYS. Let me do this. Mr. Sanders has to be at another

hearing. So, why do I not give him the floor. I am going to be here.

Mr. SANDERS. Thank you very much. I will do my best to come

back. I think I will be able to do that. Just two questions, Mr.

Chairman. I think Dr. Mather might be the right one to answer,

if not, whoever can answer it. The Persian Gulf War Veterans Act

of 1998 provides the Secretary of Veterans Affairs with the authority to administratively determine and issue regulations, determining a presumption of service connection between the disease, illness

condition, and an exposure to a hazardous material or combination

of materials, et cetera, during service in the Gulf based on the recommendations of the NAS study.

That is what the Persian Gulf War Veterans Act does. The Veterans Program Enhancement Act of 1998 requires the Secretary

merely, here is the difference, to review the NAS recommendations

and subsequently forward his recommendations regarding determination of service connection to Congress.

46

I know what you are trying to do is implement to the best degree

that you can both laws. You have a conflict over here to some degree. So, my question is what assurances can you give us that NAS

findings will be reflected completely and accurately in the regulations called for in the Persian Gulf War Veterans Act to actually

provide assistance to deserving Gulf war veterans?

In other words, the bottom line of this and the reason that Chris,

others, and I worked so hard on this was not some academic reason

or scientific reason. Essentially we want to make sure that those

people who are hurting were sick as the result of exposure actually

get benefits. Could you, Dr. Mather, or Mr. Thompson, or whoever

else answer that?

Dr. MATHER. I can certainly answer from my understanding. My

understanding is that the scientific associations will be reflected in

the Secretary’s action on presumptions of service connection when

they are received. He will both report to Congress and he will use

that information to establish presumption.

This is certainly the way it has happened with the Agent Orange

reports. As the scientific evidence of an association was sufficient,

either the presumption was established or in the case of birth defects, VA sought legislation to provide that.

Mr. SANDERS. So, if the presumption is established, if we find the

cause and effect——

Dr. MATHER. It does not have to be a cause and effect, only that

there is a significant association.

Mr. SANDERS. Yes, OK, right. That will then result in regulations

being drawn up. Somebody has the illness and that person will

then get the benefits to which they are entitled.

Dr. MATHER. That is my understanding.

Mr. SANDERS. OK. The second question; maybe for Dr. Tollerud.

You mentioned using Agent Orange as perhaps a basis of how we

are proceeding here. You referred to Agent Orange quite often.

Would you comment on the fact that if you talk to the Vietnam

Veterans of America, for example, they will suggest, as many other

Vietnam era veterans, that they are not happy with the status of

the Agent Orange work with Operation Ranch Hand.

The fact that unless I am mistaken, and I do not think I am, that

the vast majority of requests for benefits that go forward are denied. So, I get a little bit nervous. I am happy with Dr. Mather’s

answer, but I get a little bit nervous if you say, hey, we did Agent

Orange pretty well and now we are going to continue along that

path. Some of us have real concerns with that. Comment on that.

Dr. TOLLERUD. My comments about the Agent Orange Committee

had to do with process. I do not think that this is the forum to further debate the findings of the committee. Each of these committees were made up of, I do not know, 15 to 18 independent scientists. A part of the reason why it takes time to get there is that

if you take 18 scientists and you put them in a room, you will get

at least 21 opinions about any given question.

It takes time to resolve that. Our commitment was to have a consensus report that every single committee member could stand behind. Sometimes that meant going back to the literature, bringing

in others, et cetera. My comparison of Agent Orange to the Persian

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Gulf was not dealing with the findings but was dealing with the

process.

When we started that committee, there really was no template.

I mean this was the first, at least in our view, it was the first time

that a committee like this had taken on quite this kind of an effort,

and particularly looking at such a large number of individuals who

were exposed at such a long time in the past.

So, we took models from other organizations in terms of how they

weighed the evidence. We looked into the process and we had veterans and other interested parties come and give testimony. All of

that testimony was considered. So, that is what I was referring to.

Mr. SANDERS. That is fair enough. I will just state that in fact,

one of the things that motivated me, and I will not speak for Chris,

is my knowledge that in Vermont and throughout this country,

there are a whole lot of veterans who today are very upset about

how the Government responded to Agent Orange and their health

problems.

In fact, the reason that I played my role in pushing this thing

forward is I did not want to see that happen again. I wanted the

assumption to be that if scientists believe there is an association

between an illness and an exposure to a chemical or environmental

hazard, we are going to give the benefit of the doubt to the veteran

this time and give them the benefits and the health care they need,

rather than fighting them as we had for so many years with Agent

Orange.

Mr. SHAYS. Ms. Schakowsky, did you have any questions?

Ms. SCHAKOWSKY. Yes. Thank you Mr. Chairman.

I am new to this issue. So, you will forgive me if I ask a silly

question. You talked about the time line, Dr. Tollerud and as you

did, Ms. Stoiber, about how long the committee takes to deliberate.

Of course, we want good scientific data.

Why do we just have one committee? Why cannot we have more

committees to look at more substances so that we can move a bit

faster? I mean if one committee is good, why is not two committees

better or three committees better?

Ms. STOIBER. It is a very reasonable question and it is one we

asked ourselves because as we looked at the requirements of the

legislation and understood what the Congress wanted and obviously what the veterans wanted, we brought together our core committee for the Persian Gulf study and examined the question of

whether or not we could divide the work and consider more exposures more rapidly.

I will let Carolyn Fulco comment on this in more detail. The conclusion was we need first of all to make sure that the methodology

we are using for these exposures is one that will meet the committee’s standards in terms of assessing the scientific literature.

That phase I of this study in which we will be looking at five exposures is the process by which we will know that our approach to

this is going to yield the results that we think it should. Phase II

of our study will in fact, in a shorter period of time, enable us to

complete analysis of the remaining exposures.

Our committee members felt that until phase I is completed, we

simply cannot be certain that it could be divided into multiple

groups and essentially run in parallel. There is an enormous need

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to make sure that we keep consistency in the analysis of the different exposures and also a need to make certain that we have

carefully looked at all of the available literature.

If we hurry it, we may end up missing some critical evidence

that would establish a conclusion that may be missed otherwise.

Ms. SCHAKOWSKY. Let me just ask you a question then based on

what you have said. After Phase I it would seem to me possible,

unless a methodology is established, that one could have more committees; could one not?

Ms. STOIBER. We do not believe that multiple committees are the

right approach. We believe that you have to maintain consistency

across all of these. The remaining exposures can be analyzed as we

have proposed more quickly because we have the methodology in

place and we are confident of it.

Dividing the work among independent committees who will then

have to confer with each other and review each other’s work to

make certain that everything is being treated consistently would

not shorten the process. It might in fact lengthen it as we go into

the overall review. If I could ask, Carolyn, do you have anything

to add to that?

Mr. TOLLERUD. Can I add a comment?

Ms. STOIBER. Sure.

Mr. TOLLERUD. I think from the standpoint of a committee member, and we have not had any discussions related to that particular

question or issue. I have not been involved with any of the IOM’s

internal deliberations. So, this is just off the cuff from me. First of

all, there are no silly questions. There are only silly answers.

From a committee’s standpoint, I guess I would second the notion

that adding manpower essentially and dividing into small groups

is not likely to shorten the process and in fact may well lengthen

the process.

What I observed in three consecutive IOM Committees where

each subsequent committee was made up about 50 percent old

members and 50 percent new members in order to have a new infusion was this.

The first third or so of the second committee’s process or the subsequent committee’s process was heavily involved with understanding what the first committee had done so that they could either disagree and do something differently and then explain it or carry on

that process with some consistency.

We as scientists reviewing other scientists’ work are extraordinarily skeptical people. You start with the premise that you probably screwed up and let us see if we can make it better. It takes

a long time to work through that and make a decision about

whether or not in fact the process did work or did not work.

Each committee came to the conclusion that the process in fact

did work. By the end of their deliberations all were confident that

the process has worked very well. My concern is that if you have

several committees or two committees going on in parallel, they are

going to be divergent.

You will end up at the end with either a conflict in the reports

or some inconsistency in the reports which I think is the last message that anybody wants to send to the veterans, that after all of

that amount of time and effort, they still did not get it right.

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I appreciate the committee members’ comments that there continue to be veterans who are dissatisfied with the sum total of

what has been done with Agent Orange. I fully understand those.

As a physician I understand those concerns. Nonetheless, It has

been my sense in talking with veterans’ organizations and my scientific colleagues that virtually nobody agrees with everything in

the report. That is fine. At a minimum, I think virtually everyone

agrees that the process was sound. That the work has integrity.

That it has stood the test of time.

The last committee in fact found very little to tinker with in

terms of the levels of evidence. Each of the conclusions of the prior

committee were found to be strengthened by the dozen or 2 dozen

major new studies that have come out in the last 2 years.

So, that gives us a lot of confidence that we in fact did it right

and that the documents are there and they will stand the test of

time. They will not have to be second- guessed in the future. I

think that is important.

I understand the difference between 18 months and 3 years,

whatever the time difference is, for somebody who is suffering, for

somebody who has a condition, for somebody who is waiting for

compensation, or for somebody’s spouse who is waiting for compensation, or children. It seems like an eternity.

I think it is just critical that we do it right. If you rush the process and do it wrong, or do it substandard, or do it in a way that

can be challenged, then that difference in time span will, I think,

I mean any level of conflict about the results, any challenge to the

results in my view will absorb much more time than the marginal

amount of time commitment to do it right the first time. This was

just a personal opinion.

Ms. SCHAKOWSKY. Can I ask one more?

Mr. SHAYS. One of the advantages of having less members is that

we do not have a clock.

Ms. SCHAKOWSKY. OK. Again, I feel disadvantaged by not being

a scientist. My understanding is the committee is reviewing these

sets of exposures. If there is a certain methodology that has been

established to do it that clearly if we are talking about 13 groups

or 30 different chemicals or whatever it is, if you have to repeat

the same thing over, and over, and over again, that dividing it up

again, explain to me why once you have established what the scientific method is, the methodology, why you have to have it all

done by the same group.

Mr. TOLLERUD. Well, the reason is because the methodology is

not unfortunately a numerical approach where a board or a group

of people can rank different papers or whatever and at the end of

the day count it up and it comes down. I mean the exposures are

complex. The levels of exposures are complex.

The studies to evaluate them are complex. They are rarely, if

ever, sort of direct measurements. There are a lot of assumptions

that go into that. In the end, the reason the IOM I believe chose

to bring together independent scientists who did not have prior experience is because in the end these are judgment calls.

There are very few, with Agent Orange for example, there were

a few conditions, which seemed apparent from the beginning, and

they were in the sufficient evidence category. Frankly, we did not

50

spend a great deal of time looking at those. If the evidence was

clear, if the evidence seemed to be overwhelming, the evidence was

reviewed and it was cataloged, but that went very quickly.

Unfortunately, for most of the conditions of concern to veterans,

I would say the vast majority of conditions that are of concern to

veterans do not fall into those sort of clean evidence categories for

a variety of reasons, not the least of which has met most of the concerns that I have heard relate to conditions that are relatively common in the general public.

The current theme for Agent Orange, for example, one of the biggest concerns that is sort of on the scientific horizon is whether or

not diabetes might be associated with Agent Orange exposure.

There is an enormous amount of scientific evidence to go into it.

This is something that is so prevalent in society that it becomes

a very complex question and a lot of judgment to understand

whether in fact this is diabetes in and of itself or diabetes that

might have been related to a specific exposure.

The answer to the question is that it is a difficult process with

a lot of judgment. We say methodology and it sounds clear cut. The

methodology in this that ultimately decides where conditions are

placed in the categories of evidence which ultimately influences

VA’s reaction, in terms of the legislation, if you read those categories of evidence, and we can provide them if you want, but if

you read those categories of evidence, they are judgmental.

The sufficient evidence means that one or more studies are evaluated as being high quality without bias and a whole bunch of

other things that can cripple the value of a study. All of those are

judgment calls. For the conditions that are of most concern there

are studies on one side and studies on another side. It takes a lot

of weighing of that evidence to come forward.

Ultimately what a single committee does is they will make up

their mind in the first part of the study, phase A if you will or

whatever the beginning is. They will make up their mind. Everybody will sort of lock into it. The committee will lock into sort of

an understanding of where they are going to make the cuts. What

is going to be the standard that this committee is going to evaluate

in terms of strength of evidence?

It will be a judgment. There is always a gray zone there. The

committee will say that this is going to be our standard that we

are going to stand by. Once you do that, then you can begin

clicking through the various exposures much more quickly than

starting up other committees that have to go through that whole

process, lock into a certain way they are going to make their divisions between the categories, and pray that, that committee’s divisions are the same as the first.

I think what we all would not like to see is to have veterans who

were exposed to depleted uranium treated differently than veterans

who were exposed to biologicals, for example, because one committee thought differently from another committee. Again, I think that

the time consuming part of this process and the gelling of a committee are a real phenomenon.

It is not artificial. It takes time for those independent thinkers

to come to a consensus. Once you have done that, once you have

got that committee gelled, then you can move fairly quickly

51

through the other exposures. I think that at that point adding

manpower simply dilutes the process.

Mr. SHAYS. Thank you very much. They were excellent questions.

That was very helpful to the committee and I appreciate the responses. I know that this committee is going to attempt to monitor

this process, but I am really unclear right at the moment how we

are going to do that.

Jim Toote had given us his reading of the act and the time line.

I believe that the VA has given us their kind of sense of what the

time line is. I think that maybe I need to understand something

pretty basic. The VA has asked you to do this study.

So, this issue is, I mean through Congress, but this issue, you

have a contract with the VA. So, the whole issue of time lines is

an issue that I need to address more with you than with the VA?

Ms. STOIBER. Our contract has certain time lines specified in it.

In terms of what we are able to do and deliverables at a certain

date, then we need to discuss it. Obviously, any matters that are

at issue with the VA we cannot speak to.

Mr. SHAYS. Well, let me just cut through some of this as I see

it. If this is an issue that the contract allows you a certain process,

then that is one thing. If it is an issue that is that science simply

does not enable you to do it differently, then that is another.

As I listened to your questions the gentle lady from Illinois, I am

struck by the fact that says—well, my understanding is, for instance, the bill requires a list of 34 toxins. It is my sense that we

are going to begin with five, give or take.

Ms. STOIBER. That is correct.

Mr. SHAYS. You have attempted logically to identify the five that

the veterans were most concerned with and what scientists as well

thought might be the most serious. Is that correct?

Ms. STOIBER. The scientists felt there were any number of ways

you could begin the analysis and that the proposed exposures favored by the veterans groups are as good scientifically as any other

approach. There was no difference in terms of thinking about priorities.

Mr. SHAYS. Well tell me why, other than resources, you could not

do a study of the five, a study of another five, a study of another

five, and a study of another five all at the same time, other than

resources?

Ms. STOIBER. Right. Let me first answer the question that was

implicit in your preface to the question, and that is was the contract the constraint for us? When the VA approached us initially

about doing this study, they did not have a specific timetable specified in their approach to us. They asked us basically to give them

a proposal for how we could approach this work.

Therefore, the timeline that is provided in our contract is really

a timeline that we recommended to the VA for assessing the 34 exposures. So, the constraints are not artificial from the VA to us.

They really are reflective of what we thought it would take to do

the job in terms of our committee process. There are some obviously ancillary issues of interim reports and so forth that I think

can be dealt with. So, that is not what I am addressing.

Mr. SHAYS. Let me just tell you. I take a bit of a bias here and

I am going to be really candid. I would always want to be candid,

52

but I am going to say what I think about that. I can ask someone

to build my house. I am going to tell him what I want built. He

is going to tell me how it fits in with his schedule of other houses

he is building.

I need you to be a little more precise about the timetable because

the law is clear. It would be really misleading for us to leave today

thinking that the only restraint would be good science. If in fact

we put more resources into this, then could it be done sooner? Were

you, for instance, given a specific contract with a certain amount

of money allocated?

Ms. STOIBER. I was not a part of that negotiation. I think my colleagues could answer that, that was not a part of the discussion.

Mr. SHAYS. I need you to come up. Let me say to you that I

would think that you had been given some kind of budget. So, it

is not a criticism. I just want to know the score.

Ms. STRATTON. Actually, Mr. Chairman, we proposed a budget to

them. So, VA did not tell us how much they have in their pot to

pay for this study. Rather we decide what it will take to do the

project in the best interest of the science and develop a budget

based on our experience from doing many studies similarly. Then

we submit a proposal with a budget to the VA, which they accepted

in full with no modifications. So, in fact it really was what we proposed to them.

Mr. SHAYS. This is basically allowing, in a sense, the consultants

to write their own contract. You are going to write it, in my judgment, to fit your needs as well as the needs of the person providing

the request.

Dr. MURPHY. I do not know that you got a sense of the kind of

process we go through in developing contracts with the National

Academy of Science. They are an independent organization. We

sent a letter to the NAS on October 31, 1997 requesting that they

consider doing this committee work for us with a specific set of criteria that we would like to see the committee include in their

study.

Also, I think that it would be fair to say that the IOM and the

VA had lengthy informal discussions about how to proceed. They

developed a process, developed a budget, gave the proposal back to

us then Kathleen Stratton and I discussed in detail whether there

was any way, knowing the urgency and the concerns of the Gulf

war veterans and their families, whether this process could be

shortened.

From the very beginning, VA recognized that Gulf war veterans

do not want answers 2 years from now or 5 years from now. They

wanted answers back in 1992 when they first returned from the

Gulf.

Mr. SHAYS. I think that is accurate.

Dr. MURPHY. So, we recognized that from the very beginning and

discussed at length about how the process might be shortened. We

came to the conclusion jointly that NAS had developed the best

proposal that would produce valid scientific answers.

Mr. SHAYS. Let me just say to you that I was with you until that

last point. It is just hard for me to imagine that it is only one way

and one way only. I cannot believe that. I cannot believe that with

additional resources that it could not be done more quickly, unless

53

you are telling me that you have to allocate your resources somewhere else.

Ms. MURPHY. The resources that are scarce for us are not those

that we could buy with additional money in the contract. The core

of our work is our ability to identify and engage the volunteer time

of a diverse range of scientists who not only have to be the leading

experts in the given areas on a committee, but also are precluded

as we indicated in the beginning from holding contracts with the

sponsoring agency, of having any kind of consulting or other financial or personal relationships with businesses that could benefit or

suffer from the findings of the committee.

So, you start with a relatively small pool of experts who would

be suitable to serve on the committee. You diminish that pool further by the exclusion of those who might bring bias or conflict of

interest to it. Then you have to find people who can fit this in their

otherwise busy schedules.

The quality and the authority of our work depend entirely upon

our ability to get people to volunteer their time for this. It is a very

significant amount of time that they have to devote to it. In just

the first exposures that we will look at in the study that we have

commenced, the committee members will be expected to review

probably 12,000 to 15,000 articles that yield information of different quality and different perspectives on these exposures.

That means a great deal of not only of the literature, but then

coming together to deliberate and argue about the value of different studies. So, it is an enormous time commitment for them to

make.

So, our constraints are not those of the IOM. I would gladly go

higher several additional staff people and wrap up a process if that

could enable us to give accurate and conclusive results. Our limitations really are those of finding the scientists who can meet our

standards and participate.

Second, what Dr. Tollerud said of assuring that you do not create

a process in which multiple activities end up giving you a lesser

quality product and one in which different groups of veterans, depending on the exposure and the committee, might have different

levels of consideration. So, if we could do it faster, we certainly

would and would not hesitate to ask for the resources to do it.

I want to assure you that we spent a great deal of time internally trying to figure out if there was a way to create parallel committees and not diminish the authority of the work that we provide.

Dr. TOLLERUD. Could I.

Mr. SHAYS. Sure.

Dr. TOLLERUD. I need to follow that up. I am glad you jumped

in front of me. I do consulting for industry. I do consulting for the

city of Philadelphia in dealing with some of their environmental

concerns. I know how consultants work. There is no question in my

mind that VA could find a consultant to get this done in half the

time that is even asked for in the law and to come up with a document that gave all of the looks of integrity.

You could not pay me enough to be on this committee, if it were

a matter of resources. I have been at this for 8 years because it is

the Institute of Medicine. There are very, very few other organizaVerDate 11-MAY-2000 11:36 Aug 23, 2000 Jkt 000000 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 C:\DOCS\65548.TXT HGOVREF1 PsN: HGOVREF1
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tions that I would put this level of effort into. I belong to a dozen

or so professional organizations. I do not give any of them any comparison level of time that got me to the first committee.

Mr. SHAYS. How does that relate to my question?

Dr. TOLLERUD. Because the whole key to why this takes time is

that the scientific process of those of us who participate is the limiting factor. It is not staff. It is not anything you can buy with more

money. The fact of the matter is I have been a part of the selection

process of choosing or at least recommending colleagues of mine to

be on the second committee and the third committee for Agent Orange. There are not very many of us out there.

Mr. SHAYS. None of this is intended to be disrespectful or to anything other than to just try to understand this, but why do you

have to be the only person?

Mr. TOLLERUD. I do not, but the pool of people who fulfill the

particular criteria that the IOM have taken with respect to veterans studies, which is a different set of criteria than for some of the

IOM studies I believe. It is one that eliminates the vast majority

of potential candidates for participation.

Mr. SHAYS. I respect your organization, Ms. Stoiber, more than

you can imagine. So, I kind of give deference to it, especially since

I do not have the expertise and since I would be a generalist in this

issue. I have this analogy. I can understand that if I plant a seed,

then I cannot mandate by law that this grows into a beautiful

plant in 1 month when it is going to take 3 months. I can wonder

why we do not plant more seeds.

If I have a sense that we are going to do five and then we are

going to wait until that plant grows, then we are going to study

it, and then we are going to plant another seed and wait until that

plant grows and then we are going to study it, you know, way off

in the distance we are going to be able to collect all of this information, and that is what I am wondering. Why can’t we plant more

seeds?

Let me say this to you. Whether you recommend it or not, I am

talking about the cannot. I am talking about that first. I want to

understand if it is resources, if it is that there are only a few good

men and women to do this study, and I do not mean that sarcastically.

I sounded that way, but I do not. I truly do not; whether there

truly are only a few good people to do it. I want to understand that.

Then I am going to have a better sense of the timeline.

Ms. STOIBER. It truly is not a question of resources that are

money dependent. It is a question of whether or not we can first

of all conduct the study in a way that meets your expectations and

our expectations for the accuracy and the conclusiveness of the answers that we give you.

I assure you that the IOM would be very willing to speed up this

process if we believed there were a way to do it without compromising the final report. Based on the strong need of the veterans community to have answers to this, and the interest of the Congress

and speeding up those answers, we can certainly revisit the question with our committee at the conclusion of phase I in which we

have worked through the first exposures. We will then have a level

of experience in whether or not there is any feasible way to expand

55

the committee, operate with sub-panels, or in any other way get

the process moving faster.

I assure you that until the conclusion of phase I, it is not possible

to even have that conversation, but that we would have not the

slightest hesitation in coming back to you and coming back to the

VA and saying that we could cut this by months or longer if we

were able to accelerate phase II. At this stage, I do not want to

hold out the possibility that we could do that because we have consulted extensively and do not think that is possible.

Mr. SHAYS. Phase I will be done when?

Ms. STOIBER. Phase I is August of the year 2000.

Mr. SHAYS. We required it to be done when?

Ms. STOIBER. April 2000, but you required that the entire set of

exposures be done by April 2000. We are delivering a sub-set of exposures by August 2000.

Mr. SHAYS. Have up to five, give or take?

Ms. STOIBER. Seven, I am sorry. I misspoke.

Mr. SHAYS. Let me just say this to you. I am not convinced about

this one part. I am not convinced of that, and I could be just totally

off base, but I will tell you. My mind says that you can do more

than or maybe I do not understand this. Does the same group of

people have to do each one of these phases in order for there to

have this common knowledge or can different people do each one

of the toxins? You could have a group of toxins here and toxins

here?

Ms. STOIBER. Let me let my more scientifically qualified colleagues answer that.

Ms. STRATTON. I think it is a little bit of both. The answer is a

little bit of both. Basically, the committees tend to break into working groups who have primary responsibility for specific compounds

or health outcomes. That is most likely the way that this Persian

Gulf Committee will choose to operate. We believe that they will.

They will firm that up next week when they have their committee meeting. That does not mean that they do not need to spend

a great deal of time together explaining to each other what the primaries for that particular compound have read, have studied, and

the questions. They need to be able to test each other back and

forth and make sure that everyone is in the agreement and the full

breadth of the scientific questions have been evaluated.

So, they are in small groups. There is a great deal of time spent

as a whole sharing the information back and forth. This is the consistency and consensus requirement that Dr. Tollerud referred to

that, by experience with veterans and Agent Orange, we understand to be critical to the quality of the work that we have done.

Mr. SHAYS. Let me allow other Members to ask some questions.

I will just say, Ms. Schakowsky, your question really generates an

answer that I am not, well I guess I will ask you to come back to

the subcommittee and just let us know what truly is a financial restraint and what is a resource restraint. In other words, there are

only so many people that you can turn to.

If in the end a good faith effort to live by the statute, which will

not be abided by, by the letter it seems fairly clear by the statements here, but the spirit could be respected even more. I would

love to know if this committee of 18 can be expanded a bit; if you

56

can be looking at more toxins at the same time by allowing others

to be involved in this process and still be able to tie it together in

a package.

I am going to just conclude at the end, when my colleagues are

done, to go through the timeline with you just a little bit. Maybe

you could start to look at it now and tell me which ones tend to

be the biggest hurdles. That would be very helpful to me. Mr.

Sanders.

Mr. SANDERS. Thank you and my apologies to everybody. I had

to run out to another hearing. Let me concur with the chairman’s

concerns. I hope I am not repeating and if I am, please stop me.

I do not want to go over the stuff that you may have gone over.

Very briefly, I became involved in this whole issue, not only because of concerns with veterans and so forth, but of a prior experience. That is people in my District were becoming ill because of exposure to certain types of carbons and so forth and so on. I became

then more involved. I got kind of sucked into the whole issue of

multiple chemical sensitivity.

I do not want to speak for the chairman, but I think one of the

frustrations we have in this whole process is we saw veterans who

came before us who were very terribly ill and the VA was saying

we do not know what the cause of the problem is, and they do a

study, and the study does not show. It proves that of everything

out there, nothing causes the problem.

In my own State of Vermont, I had a meeting. We are a small

State. We did not send a whole lot of folks over to the Gulf. A couple of months ago I had a meeting in Burlington, VT. We had 120

people who were at the meeting who are ill from Gulf war illness.

Every time we ask the VA what is the cause of the DOD, there is

no cause. We do not know. Where there is a problem, we do not

know. We do not know.

Sometimes I am wondering if they are looking in the right direction to start with. The bottom line is I, personally, believe in a phenomenon called multiple chemical sensitivity. I believe we live in

a toxic society. I believe the Gulf war theater was an enormously

toxic environment combined with pyridostigmine bromide, combined with the possibility that some of these guys absorbed depleted uranium, combined with the fact that nerve gas was out

there when we blew up a depot.

We are looking at a real toxic environment. Now, my concern is

that there are very honest, decent, intelligent, hard working scientists who just do not believe this. They do not believe this. I

know the AMA is split on this. I have in my District guys who

when they walk down a supermarket aisle, if they are exposed to

detergents, they get sick.

Their wives cannot wear perfume. They have short-term memory

loss. These are hard working guys who have never experienced this

phenomenon until they went over to the Gulf. So, my concern is

and maybe Dr. Tollerud if you could begin this discussion, do we

have people, and are we going to have people looking at this who

are sympathetic to the concept who believe in the concept of multiple chemical sensitivity, or do we have folks that say hey, that is

really quackery and fraud as some believe and there is nothing

there?

57

Dr. TOLLERUD. I cannot give you a direct answer because actually I know nothing about the make up of the Gulf war committee.

I can speak from the makeup of the Agent Orange Committees. I

would guess since the process is the same that the choice of scientists would be similar.

I do not recall in the committee process ever actually having a

discussion about multiple chemical sensitivity. I think if we had, it

would have been set aside right away because we relied on what

the scientific literature said.

For somebody to say I am not going to look at that scientific article because I do not believe in MCS would be the same as saying

I am not going to look at that article because I do not believe in

leukemia, because I do not believe in brain cancer, or because I do

not believe in diabetes. The fact of the matter is that the peer review literature, which is what we relied on, and I mean there is

the point.

Mr. SANDERS. Who reviews peer review literature? In other

words, if you do not believe in it, and I have seen this many times,

I have talked to several hundred physicians who inform me that

they are treating people who are made ill by carpets. I am telling

you a fact.

I can go to other physicians who say that is all nonsense. That

does not exist. There is no illness made by toxic carpets. Who is

right and who is wrong? If you have as your peer review those people who do not believe it, then you are going to have all, and I have

seen this. There is a wall between these guys. Is that true or is

that not true?

Dr. TOLLERUD. That is true. There are similar disagreements in

the scientific community as there is in the therapeutic community.

What I would say with respect to the peer review literature, which

is why we in a scientific sense we always go back to the peer review literature. That process is one that is supposed to not allow

for opinion to be an overriding consideration.

In fact, there is a whole appeal process for scientific journals. If

a scientist believes that their article was crossed out of the journal

or prevented from coming into the journal because of an opinion

rather than scientific fact, then there is an appeal process.

Recently, there has actually been much more use of a different

process where when you submit an article to a scientific journal,

to a high quality journal, you submit the names of several reviewers who you would suggest as the writer of the article would have

the scientific integrity and opinions and knowledge to be able to

judge that article.

By and large, at least one of those people ends up being reviewers. The second list that I submit is a list of people that I believe

are conflicted and have a conflict of interest. I do not have to specify what that conflict is. As in any other thing, there are scientific

people who believe in cold fusion and who do not believe in cold fusion.

If you are going to submit an article to a scientific journal, you

can list people who you believe have already made a stance who

are closed-minded. Ultimately, it is the editors of the journal and

the editorial boards of the journal who make that final decision

about how exclusionary you can be. That is the process we use. We

58

needed to rely on that because otherwise, frankly, we would be

faced and we were faced in testimony, for example, where we would

have testimony from veterans who were clearly affected by disease

and who were explaining the exposures and stuff to us.

Then we would get testimony from somebody else who might

have been a veteran, who might have been a contractor, who might

have been a politician who would have given equally strong testimony in the other. We did not feel that it was possible for us to

judge the absolute validity of either of them.

We believe that people were telling us what they thought. Ultimately, what we could do as scientists, if we wanted to have something that the VA and Congress could use on which to base their

policy judgment, we simply had to stick by the science.

Mr. SANDERS. All that I would say, and I will conclude in a moment, is this. There is some good news out there. The good news

out there is that there are a number of scientists and physicians

who I think are making some breakthroughs in Gulf war illness in

terms of understanding the problem and in treating the problem.

There is right now through the Veterans Administration two

clinical trials for $20 million testing a thesis by Nicholson who was

here from California. There is another trial based on some of the

work done at Walter Reed Hospital for disease management. That

is good news.

The bad news is that, and I would love to be corrected, as of

today, I do not think the Veterans Administration or the DOD, I

think their official position is, yes, there is a problem. If you were

to say to them what is the cause of the problem? We do not know.

We have done this study; nothing. We have done that study; nothing. Please correct me if I am wrong. Dr. Mather, am I right or

wrong? What is the cause of Gulf war illness?

Dr. MATHER. Gulf war illness, I do not think we know.

Mr. SANDERS. That is the answer we have been getting for 8

years, after spending many millions of dollars in studies. Now, does

that mean to say that they have bad scientists, or scientists who

do not want to help the veterans? That is not what we are saying.

I think there is a mindset.

I think what Chris and I, do you remember that; that whole

week over, and over, and over again? There are people who are approaching these problems in a different way. The VA and the DOD

have been pretty conservative. There are some folks who are making breakthroughs out there.

So, if all that happens after all of this stuff comes back that say,

well, you know, we know there are 100,000 or 50,000 people who

are hurting, they are in my State. I talk to them every day. They

are hurting.

Mr. SHAYS. Not everyday.

Mr. SANDERS. Not everyday. I talk to them often. They are hurting. We are failing them if all we say is, yes, we know you have

a problem, but after 8 years and tens of millions of dollars we do

not know the cause. We are not doing a good job. I would hope that

you, in whatever capacity you approach this problem, are more

open-minded. Go out to people who you may think are eccentric.

Every time I hear peer review I get a little nauseous because it

always says to me it is the same old folks saying this is a crazy

59

idea. It does not work. We do not know what is going on but this

is a crazy idea. Are you following what I am saying? Does it make

any sense to anybody?

Dr. TOLLERUD. I think that the process that is so difficult in finding participants for the committees and why in fact as the problems get more complex and more serious it becomes more and more

difficult to find qualified scientists who have not already taken a

stand. That is one of the resource issues we are talking about for

the reason that popping up several other committees is just not

feasible.

What you do not want is to have those people who have already

made their decisions on the committee. I mean it is like a jury

process where they have already made up their mind before they

are on the committee.

The whole intent of gathering the scientists the way the IOM is

doing it is to have people whom in fact have not made up their

mind. In fact, they have not even spent a great deal of time thinking about it. Sometimes a fresh look will, you know.

Students do that all of the time. Students ask the damnedest

questions because they are not smart enough to keep their mouth

shut and to not look in a different way. The committee members

are very much like that. They will say, you know, well why? Why?

Why? Why? Why?

Mr. SANDERS. The VA has just told us, and please correct me if

I am wrong, that after 8 years and tens of millions of dollars, they

do not know the cause of Gulf war illness. I do not mean to be critical. I have been critical in the past. I do not mean to be critical

today. It is not a personal thing.

I do not think they are going to get it, not because they do not

want to but for whatever reason. I am asking you to get it. That

means do not continue doing what has failed in the past. Do not

come back 5 years from now say, gee, everybody is ill. We do not

know the cause. Tell us what the cause is.

Go to people you think are a little bit strange who may not be

peer reviewed by the folks who do not know the answer. That is

what I really beg of you because I do talk. We had a conference.

Chris was not there, but some folks were. In Atlanta, veterans are

very frustrated. They are angry. They are bitter. They do not think

they are getting a fair shake. They are right. They are not getting

a fair shake. So, let us break the model. Let us talk to some different people. Thank you Mr. Chairman.

Mr. SHAYS. We are going to conclude very soon. That is not to

say, Ms. Schakowsky, feel free to ask any question.

Ms. SCHAKOWSKY. I just have a short comment. I really want to

thank my colleagues, Congressmen Shays and Sanders, for the

years of work that you have done on this. I find with my very short

exposure to this that maybe I understand now why I am not a scientist. I am not a patient person. What it sounds like you are saying is that this is going to take a long time.

I think that a part of what is missing in this whole process, and

I do not feel it so correct me if I am wrong, is a sense of urgency

about this. Mr. Sanders has been talking about the last 8 years.

What I do not hear back from this panel is that an acknowledgment that, you know what, the fact that these committee members

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are busy people is not a real good answer for veterans who are

really suffering and looking for an answer.

That may be part of the reality. I think then maybe we have to

figure out how to coordinate schedules better, or whatever it is

going to take, or find more people who are experts. I would hope

that with all of the work that has been done and the legislation

that has been passed, and the crying in the Districts of the people

who are suffering that this will move quickly.

Mr. SANDERS. May I, Mr. Chairman?

Mr. SHAYS. Sure.

Mr. SANDER. Just let me ask one question. Dr. Murphy, Dr.

Mather, after 8 or 9 years of this issue do you in fact believe that

there is such a thing called Gulf war illness? Dr. Murphy, do you

believe it in your heart?

Dr. MURPHY. I believe that there are veterans who are ill and

they have multiple different kinds of illnesses. We have talked

about that before. I do not think that everybody was exposed to the

same thing. I do not believe that everyone has the same symptoms

or the same illness. We treat veterans for the illness that they

have.

We have 120 research projects going on. There are additional requests for proposals out to study this problem. I think the IOM

Committee that has been setup will help us look at the scientific

literature and determine from the available evidence whether there

are associations between the exposures and any adverse health

outcomes.

That will help us in making compensation decisions. We also

have another committee that the IOM will be starting up soon that

will look at the issue of effective and valid treatment models. That

is a separate process. So, we have done the best we can to try to

address this issue as quickly as possible.

What you need to recognize is that sometimes science does not

always give us answers as quickly as we would like. Sometimes

there needs to be a public policy decision about how to handle these

things.

Mr. SHAYS. Let me just say, that is really a good lead in though

in one sense because that is really why the legislation took place.

Eventually, the VA has gone to the IOM to do what we would have

liked them to have done years ago, but that is water over the dam

as far as I am concerned; somewhat over the dam.

Mr. Epley, I just want to say I think your presence here today

would have been to address issues dealing with the presumption

issue. I do not want to open a whole door that we go in for a long

time.

I made this assumption and I need to know, we have a presumption that a veteran who is ill, who served in the Gulf, that their

illness will be related to their service and to the Gulf, and that

they then become eligible for certain compensation and benefits depending on their illness and so on. Is that a false assumption that

I am making?

Mr. EPLEY. No, sir. If I understand you correctly it is not. If

under this law, through this study, or under another law where a

presumption is legislated that says exposure to a toxin creates an

association or a presumption that, that veteran who subsequently

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comes down with a disease, if that presumption is legislated or if

the scientific community comes through this study and says there

is a significant association, we can create the regulatory frame

work. We can pay compensation benefits under that.

Mr. SHAYS. OK. I just want to be a little clearer. It is not waiting

for the results of this study though. We make a presumption now;

correct?

Mr. EPLEY. Not under the legislative framework we have now.

We have the undiagnosed illnesses and we do pay veterans under

that legislation from a couple of years back. If a veteran presents

himself to us today and says he was in the Persian Gulf, in the theater of operations, and he is ill, then based on medical examination

we determine that symptomatology does exist. They cannot diagnose the illness. We will pay compensation for that undiagnosed illness. We are.

Mr. SHAYS. We are making the assumption, the presumption that

their illness was service related. I am missing a fine point here

though that you seem to want to make.

Mr. EPLEY. I am not trying to.

Mr. SHAYS. No, no, no. Mr. Thompson, do you want to enter in

here? My sense was that the whole issue of presumption would be

that a person who was clearly ill would be presumed to have had

his illness, who served in the Gulf, would be presumed to have it

be service connected.

Mr. THOMPSON. No, sir. Current law requires that VA be able to

tie a disability to a period of service. Congress, at the administration’s urging a few years ago, legislated a presumption only for

undiagnosed illnesses.

Mr. SHAYS. Right.

Mr. THOMPSON. That is, those illnesses which defy medical

science’s ability to diagnose. Because of the uncertainty, the policy

was to give the benefit of the doubt with respect to claimants.

Mr. SHAYS. The issue though relates to NAS making certain findings on presumption. I need to have a sense as to—I did not think

it had to be the final package before that assumption or that presumption kicks in. So, maybe I need to be clear as to what you all

think.

Mr. THOMPSON. The law requires that as the reports come back

from the Institute of Medicine, the Secretary reviews those reports

and within a specified period, 60 days, make determinations based

upon the IOM report, as well as any other available evidence, as

to whether the level of proof rises to the levels specified in the law

to trigger the administrative creation of a presumption by regulation.

Mr. EPLEY. Excuse me, sir, may I add to that?

Mr. SHAYS. Right.

Mr. EPLEY. We have done that under the Agent Orange legislation. It is a tight timeframe, but it is something administratively

we can do.

Mr. SHAYS. How tight is this timeframe?

Mr. EPLEY. It is 60 days to make the report and then 60 days

to write a regulation.

Mr. SHAYS. A report after you have a finding?

Mr. EPLEY. Yes, sir.

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Mr. SANDERS. Chris, can I jump in and ask a question on this

issue?

Mr. SHAYS. Yes.

Mr. SANDERS. Help me out here. I am a police officer in Burlington, VT. I have blinding headaches that affect my ability to do

work. I served in the Gulf. I believe it is associated with service

in the Gulf. I walk into the hospital and I say I really cannot work

right now. I am in trouble.

What help and what benefits do I get? Is there any other category other than Post Traumatic Stress that I can receive benefits

on? What happens if I do not think it is stress? I do not want that

on my record. Can I get a benefit? How many of those benefits are

being given? Who wants to answer that?

Mr. EPLEY. Let me attempt to. If you present that way and are

examined by a physician, if they diagnose you for a condition, first

of all, and that diagnosis either is within a year of your separation

from service or if it can be demonstrated.

Mr. SANDERS. Can it be demonstrated? I will give you an example. I served many years ago.

Mr. EPLEY. Right. If it can be demonstrated that there is continuity; those symptoms have been in existence since service we

could provide service connected disability.

Mr. SANDERS. How often do you? I mean, I gave you an example.

A guy has blinding headaches. It has gotten worse. He served over

in the Gulf. I mean are you going to say, hey fellow, we cannot tell

you that this was cause by service in the Gulf? We do not know

what the cause of it is?

Mr. EPLEY. In that instance, if there we are not able to diagnose,

the physician examined and said yes, we understand your symptoms. You have one or more symptoms. We cannot diagnose that

condition. We acknowledge that you have the symptomology and it

is disabling to you. That is a situation that we would consider for

service connection under the undiagnosed illness rule.

Mr. SANDERS. How many people are receiving benefits who

served in the Gulf?

Mr. EPLEY. People who served in the Gulf, in the conflict itself,

within the theater of operations and when the conflict was going

on, our records show a little over 86,000 veterans are receiving

benefits. That represents 15 percent of the veterans who served in

the Gulf war conflict.

Mr. SANDERS. Are these health-related benefits?

Mr. EPLEY. Yes, sir; service-connected disability or disabilities

that they received coincident with service.

Mr. SANDERS. It is 85,000?

Mr. EPLEY. A little over that, yes, sir.

Dr. MURPHY. Any Gulf war veteran can receive health care from

VA if the condition might be related to Gulf war service. There

does not have to be a proven relationship with their service in the

Gulf. If they are a Gulf war veteran, meaning they served between

August 1990 and present day, they can get healthcare benefits.

Mr. SANDERS. What you are saying is that 85,000 does not necessarily include people that we would consider have Gulf war illness.

Dr. MURPHY. No.

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Mr. EPLEY. That is correct.

Mr. SANDERS. All right.

Mr. EPLEY. May I elaborate on that, sir?

Mr. SHAYS. Yes, and then I want to claim back my time.

Mr. EPLEY. Going back to undiagnosed illness, under that rule

the number of people that we are paying service connected benefits

for is 2,800 and a few over that. So, that is a very much smaller

population.

Mr. SANDERS. Is it fair to assume that under that rule we would

consider those people to be suffering from Gulf war illness; that

2,800?

Ms. STOIBER. They have a lot of different things.

Mr. SHAYS. Dr. Tollerud, what are the toxins? I made a gigantic

assumption that I am having to come to grips with here. What are

the toxins that you intend to be in your first report?

Mr. TOLLERUD. I am not on the Gulf war committee.

Mr. SHAYS. I am sorry.

Mr. TOLLERUD. I think the IOM could answer that.

Mr. SHAYS. Right.

Ms. STOIBER. Those to be covered in the initial phase are nerve

agents, including serine and cycleserine; vaccines anthrax and botulism. I always stumble on this one, pyridostigmine bromide and

depleted uranium; uranium and depleted uranium.

Mr. SHAYS. When do we anticipate a finding will be made on

those?

Ms. STOIBER. That is August of the year 2000. As I understand

it then the VA would act on those findings within 60 days of that

period. So, for these seven there would not be an extension beyond

that 60 days after the August report delivery.

Mr. SHAYS. Basically, by the presumption we are giving the benefit of the doubt to the veteran; that the VA would have to prove

that the illness was not service related. Now, you are shaking your

head, Dr. Murphy. I want to be clear. It is all right to shake your

head. I just want you to straighten me out here.

Dr. MURPHY. After the presumption.

Mr. SHAYS. You shook your head and I made a comment. Speak

in the mic and tell me the facts.

Dr. MURPHY. The IOM Committee will produce its reports. Based

on the scientific evidence that they find, VA will establish a process

to weigh the evidence in that report and makes recommendations

to the Secretary about what presumption should be created for particular disease entities. People who are then diagnosed with those

diseases are presumed to have disabilities related to Gulf war service and can be compensated.

Mr. SHAYS. Let me just conclude then by asking is there any determination, for instance, the law requires that there be an interim

report? I would prefer when we are given documents to have somebody’s name that is attached to them. Are these from the VA or

IOM? How would I know this is from the IOM?

Ms. STOIBER. We sent it to your staff with a cover letter.

Mr. SHAYS. So, it was a part of a cover letter.

Ms. STOIBER. Right.

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Mr. SHAYS. I apologize; my fault. An interim report was required.

That was not done on April 21 for obvious reasons. When will an

interim report be provided?

Ms. STOIBER. We can provide interim report very quickly and

will be happy to do so. It was not called for in our contract. So, we

did not, but we will be happy to do it.

Mr. SHAYS. This is what I am going to end up then with my request. I would like very much for the VA to negotiate a new contract attempting to respect the legislation that passed. If you feel

that the legislation requires something that is not to the benefit of

the veterans, not feasible, or whatever, just tell me that in a paragraph or two. We will have a dialog about whether we need to

amend the law or we need to somehow close our eyes to the law,

but I would like that stated.

I cannot imagine why an interim report would not be helpful. I

cannot imagine why it cannot be honored. I would think that we

would go out of our way to honor the law as it is passed.

Dr. MURPHY. I think that the IOM, sir, has already testified that

we have an informal agreement without having to go back and

amend or renegotiate this contract.

Mr. SHAYS. I am just responding to this. I am responding to what

you have provided us. I do not see an interim report here.

Ms. STOIBER. What your staff asked us to do is to compare what

our contract with the VA required versus what the law requires.

So, there is no implication that we would not try to deal with

things that are not in the contract, but just that is the comparison

of fact.

Certainly, we are happy to provide a progress report, an interim

report on where we are. In the other areas, the VA shortly expects

to award the study on treatment models. So, even though that is

not a part of our original contract, we expect to begin that shortly.

We did not mean to imply there that these were not doable, but

just not in the original contract.

Mr. SHAYS. Finally, just to conclude again, the first report is due

when?

Ms. STOIBER. On August 2000. The interim report will obviously

come quickly. The first stage report is August 2000. That will include the seven exposures that I indicated.

Mr. SHAYS. What I am coming to grips with is the fact that I

made a gigantic assumption. That presumption took place now either affirmed or not affirmed by the report, which is a gigantic flaw

in my knowledge of the bill. So, I have to take the blame for that

one. It is a shocker for me. I cannot understand why the VA fought

this given that I do not even see the cost because we do not make

a presumption for so damn long.

Dr. MURPHY. I would disagree with the assumption that VA ever

tried not to implement this legislation or ‘‘fought’’ this. We established the process back in 1997.

Mr. SHAYS. Then that was done by Congress then. When we were

voting on this last year, Dr. Murphy. When we were voting on this

last year, we had tremendous opposition from the VA on this bill.

That is a fact. Now, I am going to have to find whom that one person is, but we cannot hide from the fact that we had to fight tooth

and nail to get that bill in.

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We were told it was going to cost a horrendous amount of money.

So, I will establish what my opinion was and yours on the record.

So, we have, once again, a gigantic disagreement. I do not recall

your asking that we pass this legislation. I recall that the VA was

not supportive. Mr. Thompson, you can respond. Dr. Mather, you

can respond.

Mr. THOMPSON. I would be glad to respond. The Department of

Veterans Affairs never opposed such legislation. In fact, 4 months

before this legislation was enacted, we had an agreement with the

IOM to get started on the very thing that would create the sort of

evidence that would allow us——

Mr. SHAYS. Is this your testimony that we had presumption; that

you had anything to deal with presumption? Are you saying to us

that you began the study with a presumption in it?

Mr. THOMPSON. Has IOM began a study?

Mr. SHAYS. Right.

Mr. THOMPSON. Hoping to get information.

Mr. SHAYS. Right.

Mr. THOMPSON. With which to create presumptions if the evidence dictated that presumptions were needed in order to give veterans a fair shake.

Dr. MURPHY. I think I understand how we are not communicating. Are you asking if VA wanted legislation to establish presumption of exposure? Is that your question?

Mr. SHAYS. Yes. That is one of the questions.

Dr. MURPHY. No. VA did not ask for that particular provision.

Mr. SHAYS. It opposed it. Maybe I am splitting hair here but my

sense is that you were taking a stand against presumption.

Dr. MURPHY. I think perhaps our difficulty in communicating is

due to our different understanding of ‘‘presumption.’’ I mean I

think when somebody says there is a presumption of an association, I would interpret that to mean that anyone who is sick today

who served in the Gulf war we would presume that, that illness is

due to their service in the Gulf war.

I do not think we have any scientific evidence that says that everyone who is sick today is ill due to Gulf war service, and we are

not saying that there are not people who are sick. There are people

who are sick. There are some people who are sick that we do not

understand why.

Mr. SHAYS. The whole point of presumption was that even if 50

percent of those who are ill got it from the Gulf war, we were willing to cover the other 50 percent who were not, who were sick, who

did not get it because we could not wait for science to catch up to

the sickness.

I am slightly embarrassed and I put it on the record that my

sense of presumption is different than evidently the law is written.

I am embarrassed about that. That was my assumption. It was

very clear to me that we took a lot of heat by my colleagues when

this passed because the testimony from the sources that they were

doing on the VA was that this was going to cost a phenomenal

amount of money.

I do not see the cost because we are going to be waiting for each

of these interim reports to happen before we are willing to make

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the presumption. By then, I wonder why we even call it presumption?

So, that is my embarrassment. Fortunately, I am doing it on a

Thursday afternoon. I do not feel that the VA was at all supportive

of this legislation. Let me say something. I did not intend that we

would end this way.

Mr. THOMPSON. Let me just say that the pattern for both the

Senate bill and the House bill was the recommendation of the Presidential Advisory Committee on Gulf War Illnesses. Based upon

their recommendation, the Department first drafted the prototype

legislation that was then picked up by advocates in both the House

and Senate and introduced.

That is the reason we got bills that do not look very different

from what the administration first floated and which were enacted

almost simultaneously the same day. So, I can say with certainty

there was not legislation that would have just proposed that any

illness suffered by a Persian Gulf veteran would be presumed to be

service connected. The Department certainly therefore was not on

record as opposing anything like that.

Mr. SHAYS. Any other comments? I will be happy to hear from

any of you before we conclude.

Ms. STOIBER. I would just like to say on behalf of the IOIM that

although this has been a calm discussion, it should not reflect any

lack of commitment and real energy on our part to respond to what

we do understand to be urgent needs and problems on behalf of

veterans.

Our committee members and our staff have been working as rapidly as they could on this, including having a large amount of time

for our committees actually devoted to hearing directly from the

veterans and their representatives for exactly the reasons Mr.

Sanders suggested. That is, you need to hear directly and not filtered through research what people are experiencing and their perspectives on it.

Please know that our commitment is to do this as quickly as we

can possibly do it and maintain the integrity of the work. We will

go back and reexamine whether or not there is any speeding up

that can occur. We will discuss it with our committee when they

meet next week or the week after next. If there is, then we will

certainly do it.

Mr. SHAYS. Thank you. Anyone else?

[No response.]

Mr. SHAYS. OK. I will let the record note that the VA feels that

they were very supportive of this legislation and that was not my

understanding, but I respect the fact the VA feels that way.

Thank you. This hearing is adjourned.

[Whereupon, at 4:15 p.m., the committee was adjourned.]

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