U.S. GOVERNMENT PRINTING OFFICE

74–864 DTP WASHINGTON : 2001

GULF WAR VETERANS: LINKING EXPOSURES TO

ILLNESSES

HEARING

BEFORE THE

SUBCOMMITTEE ON NATIONAL SECURITY,

VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

SEPTEMBER 27, 2000

Serial No. 106–270

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

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: (202) 512–1800 Fax: (202) 512–2250

Mail: Stop SSOP, Washington, DC 20402–0001

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

JAMES C. WILSON, Chief Counsel

ROBERT A. BRIGGS, Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

MARK E. SOUDER, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH-HAGE, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

ROBERT NEWMAN, Professional Staff Member

JASON CHUNG, Clerk

DAVID RAPALLO, Minority Counsel

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C O N T E N T S

Page

Hearing held on September 27, 2000 ..................................................................... 1

Statement of:

Feussner, Dr. John, Chief Research and Development Officer, Department of Veterans Affairs, accompanied by Mark Brown, Ph.D., Director,

Environmental Agents Service, Department of Veterans Affairs ............. 49

Sox, Harold, M.D., professor and chair, Department of Medicine, Dartmouth-Hitchcock Medical Center, accompanied by Samuel Potolicchio,

M.D., professor, Department of Neurology, the George Washington University Medical Center ................................................................................. 27

Letters, statements, etc., submitted for the record by:

Feussner, Dr. John, Chief Research and Development Officer, Department of Veterans Affairs:

Followup questions and answers ............................................................. 75

Prepared statement of ............................................................................... 52

Metcalf, Hon. Jack, a Representative in Congress from the State of Washington, prepared statement of ...................................................................... 4

Sanders, Hon. Bernard, a Representative in Congress from the State

of Vermont, prepared statement of .............................................................. 24

Sox, Harold, M.D., professor and chair, Department of Medicine, Dartmouth-Hitchcock Medical Center, prepared statement of ......................... 31

(1)

GULF WAR VETERANS: LINKING EXPOSURES

TO ILLNESSES

WEDNESDAY, SEPTEMBER 27, 2000

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS

AFFAIRS, AND INTERNATIONAL RELATIONS,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

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

2247, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Sanders, and Schakowsky.

Also present: Representative Metcalf.

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

J. Vincent Chase, chief investigator; R. Nicholas Palarino, senior

policy advisor; Robert Newman and Kristine McElroy, professional

staff members; Alex Moore, fellow; Jason M. Chung, clerk; David

Rapallo, minority counsel; and Earley Green, minority assistant

clerk.

Mr. SHAYS. I’d like to call this hearing to order, this hearing of

the Subcommittee on National Security, Veterans Affairs, and

International Relations of the Government Reform Committee,

which is conducting a hearing entitled, ‘‘Gulf War Veterans Linking

Exposures to Illnesses.’’ Doubts remain, and may always remain, about the role of battlefield toxins and medicines in causing Gulf war veterans’ illnesses.

Today, we continue our oversight of the statutory process established to resolve those doubts in favor of sick veterans seeking

proper diagnosis, effective treatment and fair compensation for

their war-related injuries.

Embodying a recommendation made by this subcommittee, the

Gulf War Veterans Act of 1998 directs the Department of Veterans

Affairs [VA], not to wait for scientific certainty, but to look for any

plausible association between presumed exposures and subsequent

ill health. If credible evidence for the association is equal to or outweighs the credible evidence against, the VA Secretary is authorized to presume the illness is service related for purposes of health

care eligibility and compensation determinations.

The National Academy of Sciences’ Institute of Medicine [IOM],

recently completed a study of peer-reviewed research on four of the

agents of concern to Gulf war veterans: Sarin, pyridostigmine bromide [PB], depleted uranium [DU], and vaccines against anthrax

and botulinum toxin. The IOM report now under review by the VA

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suggests the difficulty and the urgency of linking presumed toxic

exposures with chronic health effects.

Not surprisingly, medical literature to date contains little evidence to support any association between low doses of the agents

in question and long term illnesses.

Those findings say far more about the stunted scope of scientific

inquiry over the past decade than about the likely weight of scientific evidence. The significance of the report lies in the fact the

IOM found virtually no evidence that would rebut a presumption

of a causal association between these agents and many of the maladies suffered by Gulf war veterans.

As the IOM panel noted, the task of establishing plausible doseresponse relationships was made more difficult by the lack of hard

data on wartime exposures and by the lack of adequate military

medical records.

Based primarily on studies following the Tokyo subway attack,

the committee did conclude sarin exposures inducing immediate, if

moderate, symptoms could also cause longer term health effects

similar to those observed in many Gulf war veterans. But veterans’ illnesses could not be more firmly associated with sarin because

battlefield medical surveillance did not distinguish between the

acute symptoms of mild sarin toxicity and the myriad of other environmental and stress-related health effects suffered by U.S. service

personnel.

The IOM committee was also hampered by lack of access to classified information held by the Department of Defense [DOD], on

toxic agents in the war theater. In the course of our oversight,

many have called for full access to DOD records on chemical and

biological detections. Given the statutory mandate that VA search

broadly for information on toxic exposures, the VA should join us

in pressing for declassification of all records relevant to the health

of Gulf war veterans.

Doubts remain. But our obligation to act now on behalf of those

willing to make a certain and timeless sacrifice can be subject to

no doubt, no delay. They earned the benefit of any doubt about the

extent of our debt to them. They should not be asked to wait for

certainty that might come too late, if at all.

Mr. Metcalf is joining us from the great State of Washington, and

I’d welcome any comment you’d like to make.

Mr. METCALF. Thank you very much. I do have a statement. Mr.

Chairman, I want to thank you for the opportunity to once again

be a small part of your courageous effort to answer questions regarding Gulf war illnesses and the vaccines used by our military

personnel. Your determination to move forward and find answers

has provided vital leadership for Congress on this critically important issue.

Indeed, we have an obligation to pursue the truth, wherever it

may lead us. To do less would be to act dishonorably toward the

dedicated men and women who stand between us and a still dangerous world.

For that reason, I have issued a report I would like to present

to you and to the IOM committee culminating a 3-year investigation into the conduct of the Department of Defense with regard to

the possibility that squalene, a substance in vaccine adjuvant forVerDate 11-MAY-2000 09:13 Sep 25, 2001 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\74864.TXT HGOVREF1 PsN: HGOVREF1
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mulations not approved by the FDA, was used in inoculations given

to Gulf war era service personnel. According to the GAO, General

Accounting Office, scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including

squalene.

The report reveals that the FDA has found trace amounts of

squalene in the anthrax vaccine. The amounts recorded are enough

to boost immune response, according to immunology professor, Dr.

Dorothy Lewis of Baylor University. Therefore, my report concludes

that, Mr. Chairman, you are absolutely correct in demanding an

immediate halt to the current Anthrax Vaccination Immunization

Program.

My report further states that an aggressive investigation must be

undertaken to determine the source of the squalene and the potential health consequences to those who have been vaccinated, both

during and after the Gulf war.

The report also documents at length DOD, Department of Defense, stonewalling attempts to resolve the squalene issue, which

GAO investigators characterized as a pattern of deception. I think

that’s very significant. The GAO stated that the Department of Defense denied, denied conducting extensive squalene testing before

the Gulf war, then admitted it after being confronted with the public record.

The DOD denied conducting extensive squalene testing before

the Gulf war and then admitted to it after being confronted with

the public record. I think that’s significant. The GAO revealed that

Department of Defense officials deliberating deployment of the anthrax vaccine expressed a ‘‘willingness to jump out and use everything,’’ that’s a quote, in discussing the experimental vaccines containing adjuvants not approved by the FDA.

GAO also found Peter Collis, Department of Defense official, who

headed vaccine efforts, refused to cooperate with them. The report

states that the Department of Defense has refused to act in good

faith upon the GAO recommendations to replicate the findings of

a test developed by renowned virologist, Dr. Robert Garry of

Tulane University, although Department of Defense admitted that

they could easily do so. The work of the Tulane researchers has

been peer reviewed in a scientific publication of high standing.

Finally, my report states that Congress should take immediate

action to review the findings of the GAO and the Armed Services

Epidemiological Board and provide independent oversight for the

immediate implementation of their recommendations. The board

called upon the DOD to engage in close cooperation with the

Tulane researchers.

Congress must get to the bottom of the labyrinth that has become known as Gulf war illnesses. Mr. Chairman, you have been

in the forefront of this effort. As I am about to leave the Congress,

I just want to once again commend you for your courage in this

leadership role. Please stay the course. Veterans, active service

members and their families deployed around the world are counting on you.

Thank you very much.

[The prepared statement of Hon. Jack Metcalf follows:]

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Mr. SHAYS. Thank you, Mr. Metcalf, and I was just going to comment that you will be very missed. We have appreciated your interest not only in this issue but in so many others, and I was sorry

when you announced you weren’t running again and I just know

whoever gets to return next year, they will certainly miss you, and

I will just say whatever this committee has done on this issue, and

they have done, has been shared equally with Mr. Sanders on this

issue. He has been truly at the forefront, and I welcome him here

and I welcome any statement he’d like to make.

Mr. SANDERS. Thank you very much. And as Jack Metcalf just

said, you have played an outstanding role in keeping this issue

alive on behalf of tens and tens of thousands of men and women

who are suffering from Gulf war illness, and it has been a pleasure

to work with you and I applaud you for your leadership.

Over the past 5 years you have worked diligently to hold members of the military establishment accountable for their actions

and, most importantly, their inaction. You and I and others have

worked closely to try to get the Congress and the administration

to fund serious research into potential causes and cures for the diseases known as Gulf war illness and to push for compensation for

those veterans who have contracted these diseases. I am sad to say

that despite our efforts we have up to this date only had limited

success. The findings of the IOM study that we are examining

today only serves to remind us how far we have yet to go on this

issue.

Some good news is that Chairman Shays and I worked very hard

this year to secure 1.6 million in the defense appropriations bill for

research into whether Gulf war illnesses is the result of low level

multiple toxin exposures which manifests itself as a condition

known as multiple chemical sensitivity. We will be playing an active role in making sure that this money goes for serious research

into this area.

I notice that Dr. John Feussner is here and he’ll be speaking

later, and I look forward to his discussion, the clinical study done

with doxycycline and what the status is of that report, which is

also an area we’ve worked on.

Let me begin by stating how I approach the issue of Gulf war illness, and that is when this country asks men and women to serve

in the Armed Forces and those men and women are injured, whether in body or in mind or in spirit, the Federal Government has an

absolute, unquestionable obligation to make those people whole to

the maximum medical and scientific extent possible. In addition,

the Federal Government has an obligation to compensate those veterans fairly, not to argue with them every single day, but to give

them the benefit of the doubt, and when it is clear that veterans

have been injured during their service, we should not deny them

compensation just because we cannot say which particular exposure or combination of exposures caused that injury. In my view,

on all counts the Federal Government has failed and failed miserably with respect to Gulf war illness.

You know, one of the unanswered questions of our time, and I

certainly don’t have the answer, Mr. Chairman, is that this turning

one’s back on veterans has gone on in this country for so very long.

It started at the very least in World War II when for years we igVerDate 11-MAY-2000 09:13 Sep 25, 2001 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 C:\DOCS\74864.TXT HGOVREF1 PsN: HGOVREF1
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nored the impact of radiation illness. It went to Vietnam, where

veterans organizations had to struggle for years and years to get

the VA to acknowledge the horrendous impact that Agent Orange

had, and we’re still struggling with that fight today, and look what

we have to do with Gulf war illness. I don’t understand it. I really

do not understand why when we ask men and women to put their

lives on the line, when they come home we fight them. We become

the enemy that they—similar to the enemy they fought in battle.

Over 100,000 veterans have reported suffering from some combination of symptoms associated with the syndrome we call Gulf

war illness. Certainly it is important that we exhaust every possible research avenue to find the cause and the cure but we should

not hold up compensation of Persian Gulf war veterans who have

very real illnesses, because we have failed either through incompetence, insufficient resources or lack of dedication, or just lack of

scientific knowledge, to identify the specific toxic compound or compounds that are responsible. This is particularly true because the

Pentagon’s negligence in keeping adequate records of exposures in

the Gulf theater may prevent us from ever finding a definitive answer.

As for the IOM study that we are reviewing today, I say with all

due respect to the IOM that this study only confirms what most of

us already knew. There is a dearth of research in peer-reviewed

scientific literature on the long-term health effects of exposure to

various toxins that our soldiers encountered in the Gulf war theater.

Let me just add something to that. When I used to hear the word

‘‘peer-reviewed’’ I thought that was the right thing. But since I

have been involved in this issue, you know when I hear ‘‘peer-reviewed’’ what it often connotes to me is the people who do not know

much about an issue who cannot come up with an answer in an

issue will always tell us what other people are doing, cutting edge

research, that it’s not peer reviewed and the peer-reviewed research that we hear tells us we don’t know anything, that’s the

good research, we don’t know anything when people are doing

breakthroughs, who are doing cutting edge stuff, is not peer reviewed, and that’s a problem I have seen for many years in this

issue, in this area.

As the IOM reported, the peer-reviewed literature contains inadequate or insufficient information to determine whether there is an

association between Gulf war illness and exposure to depleted uranium, between Gulf war illness and pyridostigmine bromide, between Gulf war illness and low level exposure to sarin gas, between

Gulf war illness and anthrax vaccine or other vaccines or combinations of vaccines. These findings do not come as a shock to me or

anyone else who has followed this issue.

The reason we do not have this research is that the Federal Government and, in particular, the Pentagon has failed to keep faith

with the men and women who served in the Gulf. They have

dragged their feet and, were it not for the efforts of people like

Chairman Shays and the Gulf war veterans themselves, the military long ago would have forgotten about this issue. There would

not have been—there would not be a Gulf war problem today.

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I do want to commend the IOM on their research recommendations. These track the approach Chairman Shays and I have been

advocating. Instead of looking for one single toxin as the cause of

Gulf war illness, we need to investigate the impact of the multiple,

often low level exposures that Gulf war veterans experienced. As

the IOM report states, this, ‘‘may provide a more realistic approach

toward understanding veterans’ health issues and may provide insights for preventing illnesses in future deployments.’’ Finally, Mr. Chairman, I want to express my concern that there

is still not the will within the military to get to the bottom of this

very real health emergency. In my view, it is time for the military

to make available to properly cleared independent researchers— you know, if you go back to somebody who year after year tells you,

gee, I don’t understand the problem, gee, I don’t have a cure for

the problem, what do you do? You go to a doctor that says, well,

I’m not 100 percent sure that I have it, but this is a breakthrough,

we’re working on this. And the good news is you and I know, because you have brought every serious researcher in the United

States to this committee, there are some good people out there

doing some breakthrough research. Let’s put more emphasis on

some of those people.

So I want to just applaud you, Mr. Chairman, and commend the

veterans organizations for their persistence, and you and I will continue to work on this issue, I’m sure.

Jack, thank you very much for your work over the years.

[The prepared statement of Hon. Bernard Sanders follows:]

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Mr. SHAYS. Thank you, Mr. Sanders. Just before going on with

our panel, I ask unanimous consent that all members in the subcommittee be permitted to place an opening statement in the

record and the record remain open for that purpose. Without objection so ordered.

I ask further unanimous consent that all witnesses be permitted

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

And I also without objection ask that the gentleman’s statement,

Mr. Metcalf’s statement, and report be included in the hearing

record, and I will move to include it in the full committee hearing

on anthrax next Thursday.

You have been patient. Thank you very much. We will call on

Mr. Harold Sox—Dr. Harold Sox, excuse me—professor and chair,

Department of Medicine, Dartmouth-HitchCock Medical Center, accompanied by Samuel Potolicchio, who is professor, Department of

Neurology, the George Washington University Medical Center. As

you know, gentlemen, we swear you in and then we will take your

testimony. If you would please stand.

[Witnesses sworn.]

Please be seated. I thank our other two staff for standing up in

case you’re required to make a statement. Thank you for anticipating that. It’s very thoughtful.

Dr. Sox.

STATEMENT OF HAROLD SOX, M.D., PROFESSOR AND CHAIR,

DEPARTMENT OF MEDICINE, DARTMOUTH-HITCHCOCK

MEDICAL CENTER, ACCOMPANIED BY SAMUEL

POTOLICCHIO, M.D., PROFESSOR, DEPARTMENT OF NEUROLOGY, THE GEORGE WASHINGTON UNIVERSITY MEDICAL

CENTER

Dr. SOX. Good morning, Mr. Chairman and members of the committee. My name is Harold Sox. I chair the Institute of Medicine

Committee on Health Effects Associated with Exposures During

the Gulf War, which released its report about 31⁄2 weeks ago. I appreciate the opportunity to provide testimony to you today based on

the findings of our report. And I am accompanied by Dr. Samuel

Potolicchio, also a member of the IOM committee.

The genesis of our report was a request from the Department of

Veterans Affairs asking the Institute of Medicine to study the

available scientific evidence on potentially harmful agents to which

Gulf war veterans may have been exposed. Congress subsequently

mandated a similar study specifying 33 specific agents. Before

going further, I want to clarify the scope of the committee’s work

lest there be any misunderstanding.

The committee, IOM committee, was charged with assessing the

scientific literature about potential health effects of chemical and

biological agents present in the Gulf war theater. The Department

of Veterans Affairs will use the findings of the report as it sees fit

as a scientific basis for developing a compensation program for Gulf

war veterans. Our committee was not asked to examine whether a

unique Gulf war syndrome exists or to evaluate the literature on

Gulf war syndrome or illnesses. The committee was not asked to

make judgments about individual veterans’ level of exposure to the

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putative agents, as there is a presumption of exposure for everyone

who served in the Persian Gulf theater.

For the first study of the series, the Institute of Medicine chose

to study the agents of most concern to the veterans who advised

us: Sarin, pyridostigmine bromide [PB], depleted uranium, and the

vaccines to prevent anthrax and botulism.

Because there had been very few published studies of Gulf war

veterans, most of the studies that we examined were about exposures in occupational, clinical and healthy volunteer settings. The

committee members carefully assessed each study’s quality, limitations and applicability, but it relied upon the peer review system

that precedes publication in scientific journals as well.

Let me begin with the nerve agent sarin. Relatively high doses

of sarin can cause overstimulation of nerves and muscles within

seconds or hours, creating symptoms such as severe cramping, difficulty breathing, twitching and heavy sweating.

All of these short-term effects are well-documented and our committee ranked the evidence as sufficient to establish causality, the

highest level of evidence. The long-term effects of sarin are a very

different story. The evidence is far more limited in quantity and is

weaker.

Studies describing three different populations exposed to sarin,

two involving victims of terrorist attacks in Japan and one involving industrial accidents in the United States, establish possible

links to neurological and psychological symptoms that persisted for

6 months or longer after exposure. In one of these studies some

symptoms were still present up to 3 years after exposure. In all

three studied populations, however, the patients all had an immediate, intense, widespread acute reaction, typical of high levels of

exposure to sarin. Among the symptoms that persisted over the

long term in these individuals were fatigue, headache, blurred vision and symptoms of post-traumatic stress disorder. It’s important

to remember that people who had long-term symptoms had all experienced intense symptoms immediately.

Because we are dealing with only three studies and because we

could not rule out explanations, other explanations for the effects,

the committee categorized these findings as limited or suggestive

of an association well shy of the evidence needed to establish a

strong link, but clearly warranting further investigation. We recommend long-term research to track the health of victims of the

sarin attacks in Japan, since controlled studies of them offer the

best opportunity to see if sarin has long-term health effects.

Few, if any, veterans reported symptoms of acute exposure to

sarin in the Persian Gulf theater. Therefore we concerned ourselves

with possible effects of sarin in doses too low to cause the acute reaction.

Based on available evidence, we could not form a conclusion

about an association between the long-term health effects and exposure to doses of sarin that are low enough so that immediate

signs and symptoms did not occur. Yet research with nonhuman

primates gives us a hint that low doses of sarin over a period of

several days may create delayed neurological reactions. More research is needed to substantiate this single finding.

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The second agent that we considered was the drug

pyridostigmine bromide [PB]. There have been many studies of the

short-term effects of PB. The committee judged this evidence to be

sufficiently strong to demonstrate an association between exposure

and the immediate onset of mild transient symptoms, a link seen

consistently in many studies. Long-term side effects of PB are another story. There simply was not enough evidence to draw any

conclusion about PB’s long-term effects. In other words, we don’t

know if they occur and we can’t be certain that they don’t occur.

The author of one series of studies has suggested that PB, either

alone or in combination with other chemicals, may be related to

some chronic changes in nerve function reported by Gulf war veterans. However, weaknesses in the design of these studies, which include uncertainty about whether exposures occurred and a small

number of affected subjects, made it impossible for us to decide if

exposure to PB is associated with long-term nerve damage. We recommend further investigation of this issue using an improved

study design.

The third agent was depleted uranium. Health effects of natural

uranium have been widely investigated, mostly in occupational settings, principally workers in uranium processing mills. While these

studies have shown that uranium either has no effect or only a

small effect, our committee found weaknesses in many of these

studies. We could not draw conclusions about exposure to uranium

and death from a number of diseases, including lymphatic or bone

cancer, nonmalignant respiratory disease and diseases of the liver

and gastrointestinal tract.

We were able to arrive at more certain conclusions regarding two

diseases, kidney disease and lung cancer. We concluded that there

is limited evidence of no association between kidney disease and

exposure to uranium. We based this conclusion on adequate consistent studies that showed good kidney function despite continuous exposure to uranium as it dissolved from uranium fragments

embedded in body tissues.

Similarly, at low levels of exposure to uranium, we found limited

evidence of no association between—with death from lung cancer.

At higher levels of exposure, though, the evidence did not permit

any conclusion about a relationship between uranium and lung

cancer. We recommend followup research on veterans with embedded fragments of depleted uranium and other long-term studies.

Finally, our committee considered the vaccines given to prevent

anthrax and botulism. Based on our review of the scientific literature, we concluded that the evidence is sufficient to demonstrate

an association between these vaccines and subsequent short-term

local and systemic effects similar to those associated with any vaccination. But when we sought evidence for more lasting effects, we

didn’t find any published, peer-reviewed studies that systematically

followed subjects over the long term. This situation is not unusual

as vaccines are seldom monitored for adverse effects over long periods of time.

Since troops usually receive several vaccines, often within a short

span of time, some have questioned whether several vaccines in

combination may have created a cumulative effect that would not

occur with any single injection. Although we did find some research

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on cumulative effects of combinations of vaccines, the shortcomings

in these studies made it impossible for us to form a strong conclusion. We did decide that this evidence was inadequate to determine

whether an association with long-term effects exist.

I have provided a brief overview of our report’s findings. The

IOM is beginning the second phase of the study, in which it will

examine the literature on health effects of pesticides and solvents.

This study is scheduled to be completed in 2002, as the committee

must review a vast body of literature on these compounds. Plans

for future IOM studies include completion of the studies of the remaining agents listed in the legislation. In addition, the IOM will

update its studies and reports as new studies become available in

the published literature.

Thank you. Dr. Potolicchio and I will be happy to respond to your

questions.

[The prepared statement of Dr. Sox follows:]

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Mr. SHAYS. You needed a cheat sheet like I had, Potolicchio, correct?

Dr. POTOLICCHIO. It’s an Italian name. Just follow all the vowels.

Dr. SOX. Sorry, Sam.

Mr. SHAYS. Just trying to get back at all those tough medical

names that you guys have. What we’re going to do is we’re going

to start out with Mr. Sanders, I’m going to ask some questions, and

then we’ve been joined—Ms. Schakowsky is here. I will recognize

her third and then we’ll go to Mr. Metcalf, who’s not an official

member of this committee, though he has all the rights to ask the

same questions we will, but just then at the end. Mr. Sanders. And

we’re going to go 10 minutes. We’ll do 5 and 5, roll over 5.

Mr. SANDERS. Thank you very much, Mr. Chairman. Let me start

off by asking you the question. You say in your statement, Dr. Sox,

that for the first study of the series the Institute of Medicine chose

to study the agents of most concern to the veterans, sarin,

pyridostigmine bromide, depleted uranium and the vaccines to prevent anthrax and botulism. Now isn’t one of the problems that we

have is that we’re sitting in a lovely room here in Washington, DC,

but the reality of life, when you’re at war, is that it may not be

just one—there may not be just one agent that impacts on you. For

example, 23, you’re sitting there, you’re scared to death, sitting in

the heat, that the next day there may be a nerve gas attack on you.

Psychologically what does that do to you? Meanwhile, at some

point during the theater you may have been exposed to sarin, you

may have been given a pyridostigmine vaccine, you may have had

anthrax, you may have been exposed to burning oil wells, you may

have a genetic disposition, you may have come from a place in your

whole life you didn’t absorb a lot of chemicals, so you’re more susceptible to multiple chemical sensitivity. So my life history going

into that battle is very different say than Mr. Shays. And so you

add all of those things together, isn’t there a problem that we’re

not looking at the totality and the synergistic impact rather than

sarin here, depleted uranium here? Isn’t there more to it than just

one possible agent, and isn’t that lacking in the way we’re approaching this problem?

Dr. SOX. Well, our—the answer to your question is yes. We need

to be aware of the potential for interactions between different

agents as well as potentially a person’s past history of exposure

and, in an ideal study, to try to look at the links between agents

and combinations of agents. We would have a clear understanding

of an individual’s personal exposure history, both before and after

service in a theater of war and then reliable information about subsequent health experiences, and then we would try to link those together and see if we can detect effects that would not be seen looking at a single agent. Most of the research on the health effects of

the agents that we studied were on single agents. In fact, we found

only one study in our search which suggested a possible link between two agents, one in which mice that were injected with PB

were subjected to the stress of having to swim.

Mr. SANDERS. All that I am saying, and I have got a number of

other questions, in the real world it is not just sarin, she’s in the

military, she’s suffering trauma being there, and so forth and so

37

on, that’s the reality. It’s not just we’re sitting in a laboratory and

we give somebody some sarin.

No. 2, I want to make sure I understand exactly what your report says. Am I correct that you have not ruled out, not ruled out

depleted uranium, pyridostigmine bromide, sarin gas, anthrax vaccine or multiple vaccines or some combination of these as the cause

of Gulf war illness, you have not ruled them out?

Dr. SOX. Our study was to look at the linkage between these four

exposures and health effects, both diseases that are in textbooks as

well as diseases that are not in textbooks because they’re not well

understood, such as Gulf war illnesses, and while we didn’t find

any compelling evidence that these exposures do cause health effects, neither was the evidence strong enough to conclusively rule

out that they were not present. The closest we came was kidney

disease and lung cancer with depleted uranium.

Mr. SANDERS. OK. I know that your mandate was only to review

the peer-reviewed scientific literature on links between certain toxins and the symptoms that many Gulf war veterans are experiencing. Clearly, though, you had to undertake some background research into the types of symptoms these veterans are experiencing

and the extent of those symptoms in order to do this analysis, is

that correct?

Dr. SOX. Yes, sir.

Mr. SANDERS. OK. Based on that background review, is it your

medical opinion that in general Gulf war veterans are suffering

from a physical illness or illnesses as opposed to what might be

termed a psychological condition?

Dr. SOX. Again, our committee charge was not to establish existence of a Gulf war syndrome. We read the published literature on

this subject in order to provide background for our study of these

compounds and their possible health effects, both on unexplained

Gulf war illnesses as well as other illnesses. So if you want my personal opinion as a physician, I would say that ever since the Civil

War, veterans of combat have experienced unexplained symptoms,

and there’s a great deal of overlap as you look at the symptoms

that they experience in war after war coming right down to the

present. So there’s no question in my mind but what veterans do

suffer unexplained illnesses, but this is a personal opinion. It was

not a judgment of our committee. We didn’t look at that question.

Mr. SANDERS. In your medical opinion, based on the background

research you did, in your own experience does the fact that over

100,000 Gulf war veterans out of a total of less than 700,000 soldiers who served in the Gulf war have some combination of these

symptoms suggest to you that these conditions we refer to as Gulf

war illness have a connection to service in the Gulf war? In other

words, if you have 100,000 or more folks out of 700,000 who have

come down with a variety of illnesses now, it could be absolutely

coincidental?

Dr. SOX. Well, again you’re asking me to express a personal opinion, which is somewhat more informed than the average physician,

but I am not expressing an opinion based on the findings of our

committee, and based on my personal reading of those articles, I

think that there’s a relationship between service in the Gulf war

38

and these unexplained illnesses, but that was not a subject of the

study.

Mr. SANDERS. Based on your own personal experience.

Dr. SOX. My own personal reading of those articles.

Mr. SANDERS. I appreciate that. In your view, is it possible that

we will never establish the precise cause of Gulf war illness other

than to conclude that it has some connection to service in the Gulf

war.

Dr. SOX. I don’t know how to answer that, sir. We have a number

of exposures still to study and I would not want to form a judgment

about what those studies might find. I don’t have an opinion on

that.

Mr. SANDERS. My last question is: Would you please explain

what steps you took, if any, to obtain data from the DOD? Were

they cooperative; were they not cooperative? You apparently did

not get to review the classified materials. Did you request to and

do you have staff who have security clearances?

Dr. SOX. Well, we did not actively seek DOD documents. Our

charge was to study the published peer-reviewed literature, and

there’s a history of several hundred years that states that reliance

upon scientific reports that have undergone peer review forms a

credible basis for forming scientific judgments. And DOD documents, they are not scientific reports and so—but to answer your

question briefly, we did not seek them. We were not interested in

the level of exposure of individual veterans because that’s something that because of presumption of exposure exists.

So it wasn’t part of our charge to study DOD documents, and we

did not request them.

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

Mr. SHAYS. Let me, if you don’t mind, not on anybody’s time, but

just ask Mr. Potolicchio if he would want to respond to any of those

questions that you asked. Is that all right?

Mr. SANDERS. Sure.

Mr. SHAYS. And then you can followup.

Dr. POTOLICCHIO. I think Dr. Sox has answered the questions appropriately.

Dr. SOX. If you think I am not doing a good job, you will interrupt.

Mr. SHAYS. Let me say because you’re both partners here, you

had one statement, but I don’t mind if a question is directed to one

of you to have the other jump in either with a qualifier or with

whatever. I’d like either one of you to respond to—first, I’d like to

just make a point. I wrestle with the fact that in terms of criminal

law you’re presumed innocent until guilt is proven and not, at least

in the United States, presumed guilty until proven innocent. But

I have the feeling that veterans are basically sentenced guilty because they’re ill and they’re guilty with no help in sight, and I have

this general view that’s come about through so many hearings that

because there isn’t a proven study or something that documents,

therefore they’re not going to have the presumption of an illness

caused by their experience in the Gulf and therefore they are not

going to get the help, not because there isn’t that connection but

because we can’t illustrate that in fact there is that connection.

And I understand where you come from as doctors and I think you

39

understand where we come from as people who actually sent them

off to war. And so I’m troubled by the fact that we still have a system that is not going to help our veterans and that maybe 20 years

from now they will prove there was this connection but by then it

will be too late.

So I don’t have the same kind of patience that I think some people have. My understanding is that you have looked at sarin,

you’ve looked at pyridostigmine bromide, you’ve looked at depleted

uranium, and you’re looking at vaccines that were intended to prevent, deal with anthrax and botulism, and it’s my understanding

that the committee—let me say this to you before I ask the specific

question. It’s also my sense that the bill we passed makes the presumption of exposure to 33 agents; in other words, that at least

we’re not going to debate about it and then allow—that is the keyword, ‘‘allow’’—the VA to establish a presumption that the exposures are related to illness and they’re going to look at what you

all have done and they are going to come to some conclusion. It allows but does not require.

Now when you tried to establish the categories of association

from previous IOM studies, you would first agree that in some

cases you were hampered by the fact there weren’t enough studies,

is that correct?

Dr. SOX. Enough studies.

Mr. SHAYS. I’ll start with you, Dr. Sox.

Dr. SOX. Well, there were not enough studies of a quality that

allowed you to make a scientific conclusion, yes, sir.

Mr. SHAYS. But not necessarily related to war experience?

Dr. SOX. Well, there were very few studies related to war experience. Most of them are in other settings, yes, sir.

Mr. SHAYS. And none of these studies would enable you to deal

with the isolated—all things being equal, you look at a particular

agent and then you’ve come up with some conclusions, is that correct? In other words, everything else is frozen?

Dr. SOX. Most of them are isolated studies in which you looked

at one exposure in isolation of others.

Mr. SHAYS. And so you would certainly acknowledge, as I think

Mr. Sanders has pointed out, that all things aren’t equal, all things

aren’t held constant, there’s exposure potentially to something but

there’s also exposure to others?

Dr. SOX. Yes, sir.

Mr. SHAYS. Would you make any comment, Dr. Potolicchio?

Dr. POTOLICCHIO. Maybe just one brief comment and that is, for

instance, if you take two of the agents that we’re considering here,

pyridostigmine and sarin, actually one of them is given in order to

protect the individual from exposure to the other. So they are

given, they’re sort of given simultaneously, but one hopefully is

going to be protective and there’s scientific evidence to prove that’s

the case.

Mr. SHAYS. Did you look at any studies that tried to determine

what would happen if someone took more than the required allotment of PB? For instance, I have this tendency if I am putting fertilizer on my lawn, at least I did, that if one bag was good, two

bags was better and three bags would be really terrific and I ended

up with a lawn that was totally dead, and I know for a fact from

40

our witnesses that we had some who took the pill far in excess of

what was recommended, far in excess. They went through that

same logic. Did you look at any study that would have helped you

determine that?

Dr. POTOLICCHIO. There were, we know from—and there’s clinical evidence that if you take a whole bunch of pyridostigmine, let’s

say hundreds of pills, that you’re going to really get sick, vomit and

know that you have taken it, and I think that clinical response at

least, tells you that we better not take anymore.

Mr. SHAYS. You know that from just observation, but did you

look at any studies? In your peer review that dealt with taking too

many pills, not your intuitive sense. But did you, was that part of

your reviews and what reviews did you do? I’d like to know specifically.

Dr. POTOLICCHIO. Well, there are case reports of people being

overexposed to certain agents, particularly pyridostigmine, and

they will have clinical signs. But were studies taken in a double

blind fashion that, you know, we were going to see how much can

a person take of the drug, just to see what the side effects are

going to be? No.

Mr. SHAYS. No. The view—we have had extensive testimony from

MDs that have said that once you’ve taken so many you open yourself up to exposures that you wouldn’t have been opened up to before, and the question I’m asking you is have you looked at anything in that regard?

Dr. POTOLICCHIO. The only studies that look at large doses of

pyridostigmine are those confined to myasthenics; in other words,

myasthenics have taken relatively large doses of pyridostigmine

over a long period of time and there really haven’t been any longterm health consequences of that. But as far as acute exposure to

very large doses, will pyridostigmine kill you basically? We know

well that sarin in little drops will kill you, but pyridostigmine will

not kill you.

Mr. SHAYS. That’s not what I’m asking. See, if you had been on

this side you would have been, you would have been exposed to

what we were, and that was that we had—we’d start our hearings

from sick veterans who would explain to us that they were given

really no instructions on what to do with these pills and that they

didn’t take them for days and then they took a lot of them, and

then we had researchers come in and say that the impact on your

brain and what it does in terms of it opens up the potential for

other illnesses, so—do you want to just jump in?

Mr. SANDERS. Mr. Chairman, perhaps you have a better memory

than I do, but I recall that we had the pharmacologist from Maryland, Dr. Teet, I believe his name was, who if I remember correctly

said that that there is evidence if you are—it’s one thing to take

PB before exposure to sarin, which is the goal of presumably what

that benefit was, but that if you take PB after the exposure to

sarin it has an extremely negative impact. That’s my memory, and

I was wondering if they had looked at that.

Dr. POTOLICCHIO. There is, there is evidence that that’s true because, you know, sarin, remember sarin is an agent that irreversibly blocks your cholinesterase. So in other words, once you’re exposed to it and that cholinesterase is basically crippled, therefore

41

if you take another anticholinesterase on top of it after having that

acute exposure, obviously you’re going to amplify that. That’s true.

I don’t disagree with that.

Mr. SHAYS. The question I’m asking is was that part of your peer

review?

Dr. POTOLICCHIO. The study that you’re referring to is done only

in animals. There is no evidence in humans that that kind of after

exposure is going to lead to further compromise.

Mr. SHAYS. I still want an answer, though. It wasn’t part of your

peer review because there were no studies?

Dr. POTOLICCHIO. In animals.

Mr. SHAYS. But there were no studies in humans?

Dr. POTOLICCHIO. There are no studies in humans.

Mr. SHAYS. So it’s not part of your peer review?

Dr. POTOLICCHIO. Correct.

Mr. SHAYS. So what am I supposed to conclude in that? And

what I conclude, I think, is that it kind of relates to your observation about peer review, there’s no peer review there, but I’ll tell you

what happened when your report came out. The press said there’s

no linkage, you’ve discounted and—but it’s like not having all the

facts, and this is what—you know, I know you’re doing your best

but the bottom line is what are we supposed to conclude.

Dr. SOX. Well, no evidence isn’t the same as evidence of no effect.

Mr. SHAYS. Say that again.

Dr. SOX. No evidence is not the same as evidence of no effect. So

clearly the press, if they concluded there was no effect, made a mistake.

Mr. SHAYS. I understand, but that’s the reality.

Dr. SOX. Yeah.

Mr. SHAYS. Would you walk me through, and then I will go to

my colleague, on the concept of sufficient evidence of a causal relationship, sufficient evidence of an association, limited suggested

evidence of an association, inadequate, insufficient evidence to determine whether an association does or does not exist, and then

limited suggested evidence of no association, so there are five categories. If you would walk me through those.

Dr. SOX. It will just take me a minute to find them.

Mr. SHAYS. Yeah, take your time.

Dr. SOX. First of all, the causal relationship. The evidence fulfills

the criteria for sufficient evidence of an association; that is to say,

all of the other levels of evidence, and satisfies several of the criteria that have been used to assess causality.

Mr. SHAYS. So that would be the most certain, you would have

very little doubt there’s evidence of a relationship?

Dr. SOX. Yeah, it is very hard to——

Mr. SHAYS. The causal relationship.

Dr. SOX. Yes, sir.

Mr. SHAYS. The cause and effect. The second one is sufficient evidence of an association.

Dr. SOX. And that states that there’s been a positive association

between an exposure and a health outcome in studies where other

factors that might confuse the interpretation of that relationship

can be ruled out with reasonable confidence, so that you think you

42

can focus just on the exposure and not on other factors that might

lead to the same result.

Mr. SHAYS. The next one is limited suggestive evidence of an association.

Dr. SOX. Here there’s, there is evidence of an association between

an agent and health outcomes, but the strength of the conclusion

that you can draw is limited because you can’t be sure that other

factors that might explain the results aren’t present. So you might

have four or five things that could account for the result, one of

which is the exposure. You can’t be sure that the other ones aren’t

there and accounting for at least part of the effect.

Mr. SHAYS. We have two more. Inadequate, insufficient evidence

to determine whether an association does or does not exist, and I

would assume that’s neutral, you can’t go either direction?

Dr. SOX. It doesn’t change your thinking one way or the other.

It’s like there isn’t any information.

Mr. SHAYS. But the first three lead you toward——

Dr. SOX. Uh-huh.

Mr. SHAYS. The last one is limited suggested evidence of no association. So we have those five. If you would just quickly tell me,

sarin fit which category again?

Dr. SOX. Well, the acute effects of sarin were a causal relationship.

Mr. SHAYS. So that’s the strongest you could have.

Dr. SOX. Yes, sir. And then there were long-term effects in people

who experienced the acute effects and that came in the limited suggestive category.

Mr. SHAYS. OK. That was just one higher than neutral?

Dr. SOX. Inadequate, yes, sir, and then——

Mr. SHAYS. PB.

Dr. SOX. Just to finish on sarin, evidence for long-term effects in

people who did not experience any short-term effects of sarin, there

was just no information except the one study in primates, which

obviously requires a lot of followup.

Mr. SHAYS. OK. And PB.

Dr. SOX. In PB, the evidence was sufficient of an association between PB and acute effects lasting pretty much during the day that

you took it.

Mr. SHAYS. No long-term harm?

Dr. SOX. But in terms of long-term effects the evidence was inadequate to determine whether there was or was not an association.

Mr. SHAYS. But you didn’t look at whether PB then opened the

door for other illnesses with other agents? I mean, that’s on the

record, correct?

Dr. SOX. There wasn’t, there weren’t any studies that showed us

that PB opens the door to other exposures causing, leading to illness, yes, sir.

Mr. SHAYS. Thank you, and depleted uranium.

Dr. SOX. Depleted uranium, with two exceptions, the evidence

was inadequate to determine whether an association does or does

not exist. The two exceptions were lung cancer and kidney disease

and in those cases there was limited or suggestive evidence of no

association.

43

Mr. SHAYS. OK. And then finally, vaccines to prevent anthrax

and botulism?

Dr. SOX. There was sufficient evidence of an association between

immunization or vaccination and acute effects lasting a day or two,

the sort of thing that many of us in this room have experienced.

But the evidence was insufficient, similarly, just wasn’t there. The

studies weren’t there——

Mr. SHAYS. You couldn’t determine one way or the other?

Dr. SOX [continuing]. To determine any long-term effects.

Mr. SHAYS. So that’s a neutral issue?

Dr. SOX. Yes, sir.

Mr. SHAYS. Thank you very much, and, Ms. Schakowsky, I do appreciate your patience. Thank you.

Ms. SCHAKOWSKY. Thank you very much, Mr. Chairman. I

haven’t been here as long as the chairman or Mr. Sanders, but I

have to tell you that in the hearings we have had regarding issues

where we put our people in the Armed Services in harm’s way and

the kind of information we had, it has been very, very frustrating.

It seems in some ways that the policy of our government is no news

is good news or no findings are good findings or no studies are good

studies. And I’m looking through your testimony, Dr. Sox, and I see

words like ‘‘limited studies.’’ Because of the limited studies in Gulf

war veterans, when it comes to long-term health effects of these

substances, the bottom line is we simply don’t know enough on PB.

There simply was not enough evidence to draw any conclusion

about PB. In other words, we don’t know long-term effects, if they

occur, and we can’t be certain if they don’t occur. Weaknesses in

the design of these studies made it impossible for us to decide.

When it came to anthrax and botulism, we’ve had lots of hearings on anthrax. When it came to evaluating more lasting effects,

we didn’t find any published peer review study. I’m saying pretty

much what everybody has said already. This is not unusual. As few

vaccines have been monitored for adverse effects over long periods

of time. When it comes to combinations, you say the shortcomings

in these studies made it impossible for us to form a strong conclusion, and I am wondering if we’re going to go on for another 10

years, and I realize this isn’t your fault.

I’m just trying to ask you what we can do about this. We come

and say, well, someone studied your study and what they found

was there wasn’t enough information. We keep doing studies of

studies that have been done that say there hasn’t been enough

study. So I’m wondering when we get down to doing some real

study and what your recommendations would be so that next time

we have a study we can come back with some real reports.

Dr. SOX. Well, the wheels of research grind slowly.

Ms. SCHAKOWSKY. Are they in process?

Dr. SOX. Pardon me.

Ms. SCHAKOWSKY. Are they in process?

Dr. SOX. Basically physicians have known about postwar syndromes, as I said, since the Civil War and, from my understanding,

serious research into the cause of those syndromes really has only

begun after the Persian Gulf war. So we’re, in my opinion, at the

beginning of serious, careful study of an important group of illVerDate 11-MAY-2000 09:13 Sep 25, 2001 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 C:\DOCS\74864.TXT HGOVREF1 PsN: HGOVREF1
44

nesses that have existed for 100, nearly 140 years and it’s going

to take a while to accumulate good evidence.

LBJ declared war on cancer in 1968 and we have made a lot of

progress in understanding the biology of cancer, but actually we’re

only now beginning to see some results or promise of some results

from that research 30, 35 years later. I’m optimistic that we’re

starting on a process that’s going to lead us to answers, but I don’t

expect the answers to come quickly.

Ms. SCHAKOWSKY. Well, inconclusive results of real clinical studies that happen, that’s one thing, and research that’s being done,

but I’m just wondering what the protocols are, for example, if we

had—we made a decision about how many anthrax vaccines, how

many dosages we should give and etc., and then when we come

back and say well, based on what, what is your knowledge of this,

how do we know about its effectiveness and its side effects, short

and, well, mostly long term, so at what point should we be doing

these studies and I would say that, that with agent orange, I mean,

we have known about these symptoms that result from exposures

during wartime, but are we engaged directly in the kind of research right now, and if that’s the case, I haven’t really heard

about it.

I mean, we heard when it came to anthrax all kinds of these voluntary reporting systems and no real answer as to how are we

going to determine the effects.

Dr. SOX. Well I am not an expert on the current state of research

on Persian Gulf-related illnesses. Dr. Feussner, who will be speaking to you shortly, I am sure can tell you what studies are being

done.

Ms. SCHAKOWSKY. Thank you.

Mr. SHAYS. Thank you. Mr. Metcalf does not have any questions.

Mr. Sanders.

Mr. SANDERS. Thank you very much Mr. Chairman. As I indicated earlier because of the diligence of the chairman and his staff,

we have had the opportunity on this committee to hear from, seems

to me, some extraordinary researchers all over this country who

have been doing breakthrough work, and there are a number of

them, and I don’t recall all of them, but I just was kind of curious,

two names come to my mind, and I wonder if you can give me your

views having reviewed their works.

Dr. Robert Hayley is with the University of Texas, and as I recall, not having his work in front of me, he is not ambiguous about

his belief that exposures in the Gulf have resulted in brain damage, which are causing severe physical problems for Gulf war veterans, no ifs, ands, buts and maybes, that is his belief. What’s your

view on that?

Dr. SOX. Well, the committee carefully examined Dr. Hayley’s

work and had the opportunity to talk with Dr. Hayley about his

work at one of our open sessions, and the committee ultimately

concluded that there were difficulties with the design of Dr.

Hayley’s work that made it impossible to draw any conclusions at

this point.

I think our bottom line would be that in a small population of

veterans, Dr. Hayley has done some studies that generate interesting ideas and hypotheses about the biological basis for some of the

45

symptoms that people are experiencing, but until those studies are

replicated by other investigators and larger more representative

populations, the evidence that Dr. Hayley has produced is too weak

for us to draw any conclusions upon which to base in our report.

Mr. SANDERS. Too weak in the sense that the number of veterans, the sampling was too small.

Dr. SOX. Well, the sampling was too small. He studied basically

a group of symptomatic veterans, and he, using some statistical

techniques, put them in the subgroups which seemed to have different combinations of symptoms, and then he looked at different

measures of brain function comparing one group of sick veterans to

another group of sick veterans. It’s a pretty basic principle of epidemiologic research to include an unexposed control, somebody who

never went into the Persian Gulf theater, and with the exception

of a couple of more recent studies, he has not had unexposed controls, but even putting that aside, the history of science is that you

don’t rely on one study. You, somebody does a study, and then several people try to replicate it. Sometimes they succeed and then it

becomes part of the body of scientific understanding, and sometimes they don’t and it falls by the wayside and right now, I think

Dr. Hayley’s work is in the category of remains to be repeated by

other investigators.

Mr. SANDERS. Are other people, to your knowledge, trying to replicate that?

Dr. SOX. I will have to ask Dr. Feussner to respond to that, I

don’t know.

Mr. SANDERS. What about Dr. Urnovitz.

Dr. SOX. Doctor who?

Mr. SANDERS. Urnovitz.

Dr. SOX. I don’t know about his work. Sam, do you remember

anything.

Dr. POTOLICCHIO. By name, I don’t.

Mr. SANDERS. Don’t know his name, no?

Dr. SOX. None of us.

Mr. SANDERS. Dr. Claudia Miller, peer review.

Dr. POTOLICCHIO. Claudia Miller I think—we know we’ve had exposure to Claudia Miller.

Dr. SOX. If I remember.

Mr. SANDERS. She’s involved in multiple chemical sensitivity.

Dr. SOX. She gave us a presentation. We did not review the literature on multiple clinical sensitivities and really don’t have a

basis upon which to judge her work.

Mr. SANDERS. See Mr. Chairman, may I repeat a point I made

earlier, what seems to happen, and I think Ms. Schakowsky was

making this point, we review people who say I don’t know the

cause of Gulf war illness, I don’t have a cure to Gulf war illness,

that’s peer review. The people like Hayley or Urnovitz or Miller

who say, you know, I think we’re on to something, I think there’s

something real here, those are rejected because apparently not

enough people have peer-reviewed that, we push them aside. It

would seem to me, and correct me if I’m wrong, given the fact that

after—and I don’t mean to be critical of you. I know you’re just one

part. We’ve had 100 people up here who keep telling us the same

thing.

46

So we get a little bit frustrated, but when people come up here

and they say I think we’re on to something, it would seem to me

that the logical reaction for Hayley’s work or Urnovitz’s work or

Miller’s work would be for people to jump up and down and say,

thank God, we may have a breakthrough, why are we—are you recommending for example that resources now be devoted to replicate

Hayley’s work so that 5 years from now, we don’t have people coming before us saying Hayley’s work was interesting, but nobody’s

replicated it, so why don’t we replicate it? Tell us that Hayley is

wrong or he is right, or Urnovitz is wrong or is right.

Dr. SOX. You know the history of scientific enterprise is somebody comes up with a finding and then somebody funds studies to

try to replicate that study. So the answer to your question is yes,

if somebody comes in here and makes a claim of an important result, the answer should be to fund other investigators to replicate

the result.

Mr. SANDERS. I agree with you but based on that I mean all that

you told me about Hayley, Urnovitz, you’ve never heard of Hayley.

You said there is nobody, you know, he’s out there, we don’t have

enough evidence to suggest that he is right or wrong, but you

should be coming in here and saying this guy is saying something

that’s significant, it’s different to other people, he’s claiming some

results, either he’s crazy or he’s not, let’s find out; true?

Dr. SOX. Well, yes and in our research recommendations, we

called for work to replicate Dr. Hayley’s findings.

Mr. SANDERS. One of the things that we can use—we have gone

through this for 10 years, so what we would like people to say is

look, there are some breakthroughs here, we cannot tell you at this

moment whether these people are right or wrong, maybe they’re

wrong, let’s find out and say that they’re wrong, or if they are

right, let’s devote a whole lot of money to moving forward so we

can use their research to develop a cure for Gulf war illness. I

didn’t hear you say that.

Dr. SOX. Did you hear me say it?

Mr. SANDERS. No, I didn’t hear you say it.

Dr. SOX. Well—— Mr. SANDERS. For example, tell me now, based on all of your research, if you were the President of the United States, or better

yet, if you were going to recommend to the President of the United

States, Mr. President, we have got a problem and I, based on all

of my research, advocate to you that you spend X dollars in the following areas because we have some promising breakthroughs, but

we just don’t know about it. What would you recommend to the

President?

Dr. SOX. Well, I would recommend to the President a program

of research to try to replicate some of the interesting results of investigators like Dr. Hayley, but I probably also call upon the President to establish a committee, to establish research priorities so we

don’t just focus on the areas where some scientists are working, but

also going out and looking at areas where nobody has looked yet,

perhaps for lack of funding, so in other words, we need a comprehensive approach to the study of postwar illnesses, and part of

that approach is to followup on promising results of investigators

like Dr. Hayley.

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Mr. SANDERS. But that’s where we were 10 years ago. You’ve

studied all of the literature. So I am asking you, all right, give me,

at this point, if you can, who are the people out there that you see

are doing breakthrough work that, in fact, need help right now for

additional funding so that we can determine whether they’re right

or whether they are wrong. Is Hayley one of them?

Dr. SOX. I don’t know anything about Dr. Hayley’s funding, but

clearly, Dr. Hayley is studying veterans and coming up with some

interesting results, but I’m not sure it’s Dr.—that Dr. Hayley needs

more money. It may be that other people need more money to followup on his studies and to take it to the next step.

Mr. SANDERS. That’s fine I am not here defending Dr. Hayley. All

I am saying is you’ve done a lot of research; you’re a scientist we

are not. You have studied the literature. Can you just tell us who

are the people out there you are thinking that you think are doing

breakthrough work that we should try to give more support to?

Dr. SOX. Well, the only name that comes to mind is Dr. Hayley.

I do believe that the Baltimore group has been studying the veterans with depleted uranium fragments needs continued support but

if—but I really don’t think that I should be the person to tell you

who ought to be funded. I think that’s something for more deliberation.

Mr. SANDERS. In all due respect, I disagree with that. We need

guidance. We are not scientists, you are, and what we need help

on is for somebody to come before us and say look these guys have

been doing this stuff for 10 years. It’s going nowhere in a hurry,

this is possible, this is potential we do need that kind of help Mr.

Chairman.

Mr. SHAYS. The other place we need help is when you’re looking

at what studies are available and you realize there just aren’t any

peer review studies in certain areas. I’d like to—in general, I’d like

to read one paragraph, then we’re going to get on to the next panel,

unless Ms. Schakowsky has any questions. But this is the paragraph on page 3. It’s a fairly long one, but I am going to read it

all to you. It starts out—it’s kind of in the middle of the page.

All these short term effects are well documented, and we rank

the evidence as sufficient to establish causation, the highest level

of evidence. In part, this means—and we’re talking about nerve

agent sarin—in part, this means many studies have strongly repeatedly and consistently linked these acute health effects and exposures to sarin, and that the greater the exposure, the greater the

effect, but the long-term effects of sarin are a very different story.

The evidence is far more limited and much weaker.

Studies describing three different populations, two involving victims of terrorist attacks in Japan and one involving industrial accidents in the United States, link neurological and psychological

symptoms that persisted for 6 months or longer. In one of these

studies, some symptoms persisted for up to 3 years, the longest

that any of the subjects were followed.

In all three studied populations, however, the doses of sarin were

high enough to trigger an immediate, intense widespread and acute

reaction. Among the conditions that persisted over the long term

were fatigue, headaches, blurred vision and symptoms of post traumatic stress disorder. I might just say parenthetically, that’s a very

48

common symptom for our veterans who have come before our committee. In other words, people who had long-term symptoms were

the ones who had experienced intense symptoms immediately.

Now, I want—the keyword here is ‘‘intense.’’ How did you define ‘‘intense?’’ Was it walking intense or drop dead intense? I mean,

fall down intense? What defines ‘‘intense?’’ Dr. POTOLICCHIO. The level of exposure was based only on clinical findings, and maybe one laboratory test when it was available.

You know, there is no real exposure data on sarin in any of the

Japanese populations. We don’t know how much any individual got

at any time. If you look at the reports and the way they were written up, there was a man that was 100 feet from the release of the

gas in Matsumoto, Japan, and he opened the window of his room

and that man eventually died in convulsions and respiratory arrest, and he was just a few hundred feet away, but he probably had

a maximum exposure but nobody knows exactly how much.

Mr. SHAYS. I am just trying to understand.

Dr. POTOLICCHIO. The thing is that when you get to the clinical

findings, you say, well, there has to be an intense—in other words,

someone’s had an exposure, he, at least, had some symptoms of exposure that we recognize and that would be the acute cholinergic

syndrome.

Mr. SHAYS. I understand that.

Dr. POTOLICCHIO. Or the enzyme that you measure in the blood

is depressed to such a degree—— Mr. SHAYS. Let me not get to that. Let me just get to your concept of ‘‘intense,’’ and I want to relate ‘‘intense’’ into war. I mean,

I can remember when I was being chased by some older kids who

wanted to beat me up, I’ve never run so fast. I didn’t even know

that I was exhausted. I was so damn afraid. I ran across a highway

without looking either direction, and as far as I was concerned, I

was pretty healthy, but later I realized I was just, I was just totally—I was sore, I was always these things and I was sore when

I was running, but I didn’t know that. I didn’t have people shooting

at me. So I guess what I’m trying to determine is are you making

an assumption that there was not an intense exposure in the Gulf

because people didn’t fall down or something?

Dr. POTOLICCHIO. We’re not making an assumption about anything that happened in the Gulf war theater. We’re saying if you

have an exposure to sarin, you will have acute symptoms. Now

whether or not you can identify those—— Mr. SHAYS. Describe those acute symptoms, please.

Dr. POTOLICCHIO. Well, your acute symptoms would be——

Mr. SHAYS. Would be fatigue, headaches, blurred vision, what?

Dr. POTOLICCHIO. No.

Mr. SHAYS. What would they be?

Dr. POTOLICCHIO. Your acute symptoms would be difficulty

breathing, watery eyes, probably GI upset, in other words, gastrointestinal upset, your muscles might start to twitch, and you can

actually go into a convulsion if the exposure is intense enough.

Mr. SHAYS. But not necessarily. All those symptoms I would

wager our veterans have experienced in the Gulf, not all of them

but a good number, blurred vision.

Dr. POTOLICCHIO. You wager they have been exposed to that?

49

Mr. SHAYS. We had testimony of people describing those very

symptoms, not after but during. OK. So the symptoms you have described, just for the record I will state, was statements to us by veterans that they experienced in the theater, clearly. I think we’re

all set unless you have any, Ms. Schakowsky, any questions. Thank

you all very much.

Our next witnesses are John Feussner, Dr. John Feussner sorry,

chief research and development officer Department of Veterans Affairs accompanied by mark brown Ph.D. director environmental

agents study, department of Veterans Affairs. Do you all have anybody else that would help you in any testimony? If so I would ask

them to stand up. Thank you and if you’re asked to then respond,

we would check out the names. I ask you to raise your right hands

please.

[Witnesses sworn.]

Mr. SHAYS. Note for the record that our witnesses have responded in the affirmative and Dr. Feussner, you will be making

the statement, and Dr. Brown you would also be responding to

questions. Thank you very much. Appreciate your patience.

STATEMENTS OF DR. JOHN FEUSSNER, CHIEF RESEARCH AND

DEVELOPMENT OFFICER, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY MARK BROWN, Ph.D., DIRECTOR,

ENVIRONMENTAL AGENTS SERVICE, DEPARTMENT OF VETERANS AFFAIRS

Dr. FEUSSNER. Mr. Chairman and members of the subcommittee,

thank you for this opportunity to discuss the status of the current

Federal research program on Gulf war veterans illnesses. Accompanying me today is Dr. Mark Brown, who is the director of the

VA’s Environmental Agents Service.

In your invitation letter, you indicated that the purpose of the

hearing was to review the findings and recommendations of the recent Institute of Medicine report. You also requested a discussion

of the plans for additional research by the IOM and a status report

on other research on Gulf war veterans illnesses.

To date, the Federal Government is projecting cumulative expenditures of $151 million of Gulf war research from fiscal year

1994 through fiscal year 2000. There are over 192 projects at various stages of completion in the research portfolio on these veterans

illnesses.

For the sake of brevity, Mr. Chairman, I will only summarize the

research recommendation of the Institute of Medicine report and

the response of the research working group.

With regards to sarin specifically, the IOM has recommended

long-term followup of populations exposed to sarin in the

Matsumoto and Tokyo terrorist attacks. The research working

group concurs with the IOM recommendation.

The IOM recommends studies in experimental animals to investigate the long-term effects of acute, short-term exposures to sarin

at doses that do not cause overt cholinergic effects. Since 1996, the

DOD has funded nine toxicology studies focusing on the effects of

sarin, alone or in combination.

In addition to the IOM recommendations on animal studies on

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logical studies that are focusing on the health of veterans potentially exposed to low level sarin due to the Khamisiyah demolitions,

one at the Navy Health Research Center, a second at the Oregon

Health Sciences University, and a third by the Medical Followup

Agency of the Institute of Medicine.

In addition to the IOM recommendation on animal studies on

sarin, the research working group also is coordinating a contract to

the medical followup agency to perform an epidemiologic study of

the long-term effects of short-term exposure to nerve agents in

human volunteers in experiments conducted at the Aberdeen Proving Ground in the 1950’s to 1970’s.

With regard to pyridostigmine bromide, the IOM recommends research on chemical interactions between PB and other agents, such

as stressful stimuli and certain insecticides. Since 1994, VA and

DOD have funded 30 projects related to PB alone or in combination

with other chemicals or stressful stimuli. One important and consistent result of recent studies is that stressful stimuli such as

swimming, heat or restraint stress do not cause an increase in the

permeability of the blood brain barrier or cause pyridostigmine bromide to cross the blood brain barrier into the brain.

The IOM recommends research on differences in genetic susceptibility that may contribute to increased risk of disease. VA and

DOD have funded eight projects on genetic factors that may alter

the susceptibility to the effects of PB or sarin.

Concerning vaccines, the IOM has recommended long-term systematic research to examine potential adverse effects of anthrax

and botulinum toxoid vaccination in multiple species and strains of

animals. The research working group concurs that long-term research is needed to examine potential adverse effects. Such research is underway in DOD laboratories. Also, the CDC, the Centers for Disease Control and Prevention, plans to fund nonhuman

primate studies of the health effects and efficacy of the anthrax

vaccine later this year.

The IOM has recommended identification of cohorts of Gulf war

veterans and Gulf war era veterans for whom vaccination records

exist. The CDC published a study of Air Force Gulf war veterans

in 1998 which included measuring antibodies to anthrax and botulinum to determine which individuals had received the vaccines.

The CDC found no relationship between the vaccinations and development of multisymptom illnesses.

Similarly, researchers in the United Kingdom have also published a study this year on a cohort of nearly 1,000 Gulf war veterans for whom vaccination records exist. There was no association

between having received the anthrax vaccine and the development

of multisystem illness.

The IOM has also recommended long-term longitudinal studies of

the participants in the anthrax vaccine immunization program. In

1999, DOD funded a long-term longitudinal study of participants in

the anthrax vaccine immunization program study located at the

Naval Health Research Center.

Finally with regard to depleted uranium, the IOM recommended

continued followup of the Baltimore cohort of Gulf war veterans

with DU exposure. The research working group concurs with the

recommendation. While the Baltimore clinicians have seen no deVerDate 11-MAY-2000 09:13 Sep 25, 2001 Jkt 000000 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 C:\DOCS\74864.TXT HGOVREF1 PsN: HGOVREF1
51

finitive evidence of adverse clinical outcomes associated with uranium exposure to date, the veterans who were involved in the

friendly fire incidents will remain under continuing medical surveillance.

The IOM has recommended continued followup of the cohorts of

uranium processing workers. The research working group concurs

with this recommendation.

The IOM has recommended additional studies of the effects of

depleted uranium in animals. DOD has funded five toxicology

projects that are investigating the health effects of DU in experimental animals. For example, there was no detectable kidney toxicity in rats embedded with DU pellets, even at very high concentrations of urinary uranium.

Mr. Chairman, we know that combat casualties do not always result in obvious wounds and that some veterans from all conflicts

return with debilitating health problems. VA recognizes its responsibility for developing effective treatments and prevention strategies for such illnesses.

Studies clearly show that some Gulf war veterans report chronic

and ill-defined symptoms including fatigue, neurocognitive problems and musculoskeletal symptoms at rates that are significantly

greater than nondeployed veterans.

Mr. Chairman, thank you again for permitting me this opportunity to summarize our work. You have my assurance that we will

continue this effort to resolve, or at least ameliorate health problems in our patients to the greatest extent possible.

Mr. Chairman, I will conclude my testimony here and ask that

you enter the entire written testimony into the record. I actually

think you did that.

[The prepared statement of Dr. Feussner follows:]

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Mr. SHAYS. Already covered, but it doesn’t hurt to ask. Let me

just, before recognizing Mr. Sanders, say they wish a lot of these

studies had begun 10 years ago. I think that many of them are

very important and valuable. I think that it’s good they’re happening. I wish they could have happened sooner, but I guess we call

that progress, and Mr. Sanders.

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

know, I have been very critical of the DOD and the VA for many

years in this area, but I do want to single out Jack Feussner as

somebody who I think for many, many years has been trying to do

the right thing, Jack and I appreciate the work you have done.

Let me just ask you, you remember, Dr. Feussner, a couple of

years ago at a hearing, I had indicated to you that I was distressed

that there was some apparently breakthrough work being done

around the country, and I asked you if the VA had begun the process of trying to replicate some of that work, tell us whether it was

right or wrong, and I think out of that discussion with Chairman

Shays’ help and so forth, you began a clinical trial based on I think

the work of Dr. Nicholson in California dealing with doxycycline,

and I know that clinical trial is going on in a hospital in White

River Junction in Vermont, hospitals all over this country, and the

thesis was that large doses of doxycycline over a long period than

had previously been given seemed to indicate that there would be

some alleviation of symptoms.

That was Nicholson’s hypothesis. You were testing it. Do you

have anything to report to us today about the progress of that

study?

Dr. FEUSSNER. Yes, sir, I have progress to report. You’re quite

correct, the study continues. You’re also quite correct to assert that

the treatment was doxycycline and the duration of the doxycycline

was quite long, 1 year. Because this is a—while tetracycline is not

an experimental or novel therapy, the use of tetracycline—— Mr. SANDERS. Doxycycline is what we’re talking about.

Dr. FEUSSNER. Yes, sir.

Mr. SANDERS. Tetracycline is the same?

Dr. FEUSSNER. Doxycycline is a specific brand of tetracycline. I

will try to keep it straight. At any rate, this trial, as you recall,

was planned as a collaborative effort between VA and DOD, went

through a very rigorous scientific review process that actually included a formal request for an FDA IND, an investigational new

drug not because the drug is investigational, but because the condition for which the drug is being used is not approved by the FDA.

We initiated the trial formally in May 1999. The goal was to

study—enroll up to 450 Gulf war veterans at 28 sites throughout

the United States. We have achieved that goal. As a matter of fact,

as we intended to close enrollment in the trial, we had a number

of veterans who wished to participate, despite the fact that we had

met our patient sample size quota. Nonetheless, we included an additional 41 veterans into the trial. The total sample size now is

491. The patient recruitment period is done and the patients are

currently in the process of going through that 1-year treatment.

Mr. SANDERS. Does that include, that 491, is that some of

those—half of those people are getting placebos?

Dr. FEUSSNER. Correct, yes, approximately 50/50.

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So the patients are all enrolled in the trial and are all now being

treated with the active agent doxycycline, or placebo, are in the

process of being followed on that treatment over the course of 1

year. I expect the study to be complete, the followup to be complete

next summer, approximately June or so, and that we will have the

final result some time after that, some time probably within the

next 90 days of completion of the trial. So the trial has been a success.

Mr. SANDERS. In the sense of organizing it?

Dr. FEUSSNER. In the sense of organizing, recruiting patients, but

I can’t tell you what the results are yet.

Mr. SANDERS. So in June you will be beginning the process— you’ll be completing the study and beginning the process of analyzing the results?

Dr. FEUSSNER. That is correct. You may recall, Congressman, we

also started another major trial, that one much more difficult. We

call it exercise and behavioral therapy, organizationally more complex for treatment groups. Similarly, we have closed the patient recruitment for the EBT trial. There are four treatment groups,

usual care, exercise only, cognitive behavioral therapy only or both

interventions. We did not quite meet our goal for patient inclusion.

We’d hope to have approximately 1,300 patients enrolled. We have

succeeded, however, in enrolling 1,100 patients in the trial and the

trial, whatever the result, will be statistically robust. So while we

had hoped to have a few more patients, we are very gratified that

1,100 Gulf war veterans have volunteered to help us with the trial.

That trial, as you recall, is a little later in the process than the

ABT. I don’t expect the final end point of that trial until the fall

of 2001, and probably around September or so with the same issue

that at that point, we will begin the analysis and should have the

results—pretty good result within a 90-day period.

Mr. SANDERS. And I presume—is my time up, Mr. Chairman?

Mr. SHAYS. No, no.

Mr. SANDERS. I presume that if one or both of those studies indicate that approach alleviates symptoms—that approach will become recommended form of treatment throughout the VA system.

Dr. FEUSSNER. Yes, I would say the answer to that question

would be yes, that the trials, as you know, the trials are large,

they’re very expensive and they are constructed to be definitive. So

that if the result is positive, then the treatment is known to work,

and if the result is negative, then the treatment is known not to

work.

Mr. SANDERS. Dr. Feussner, I am, as you know, not a scientist,

and the way my mind works, as I mentioned to you before, and I

appreciate you moving with that type of approach, is that if somebody is doing interesting work, we test the hypothesis, and frankly,

this work was based on what Nicholson had indicated out in California, is that correct? More or less through other people?

Dr. FEUSSNER. As you recall, sir, Dr. Nicholson’s work was quite

controversial.

Mr. SANDERS. I sure do.

Dr. FEUSSNER. There were two observations. While his results

were controversial, one of our own physicians Dr. Gordon had anecdotal experience——

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Mr. SANDERS. That’s right.

Dr. FEUSSNER [continuing]. On his own in a significant number,

not two or three, but perhaps several dozens of patients where he

had observed clinically that he had tried the therapy and believed

that the therapy worked.

Mr. SANDERS. Dr. Gordon from Manchester, New Hampshire?

Dr. FEUSSNER. Yes, sir.

Mr. SANDERS. That’s right. And it seems to me that a good administrator, such as yourself, listens to those people, who may only

have anecdotal evidence of some success. OK. So I am applauding

you for this, but let me ask you this, getting back to the question

I asked Dr. Sox a moment ago, if there appears to be some breakthroughs, what you’re saying is if Dr. Gordon came to you and said

listen, I’m applying this treatment, it appears to be working, let’s

go further with it and you said yeah, let’s go further with it, Nicholson did his work, and I think you did exactly the right thing,

what about the work that people like Hayley or Urnovitz or Miller

are doing out there? There is also anecdotal evidence that there

may be some breakthroughs. Are you prepared to say come on in,

let’s work together, let’s see, in fact, to answer the question that

Dr. Sox raised with Hayley’s work that the sampling was too small,

there hasn’t been enough replication, are you going to help us—tell

us whether or not Hayley is on to something or whether he’s not?

Dr. FEUSSNER. Well, before we get to Dr. Hayley’s work specifically, Congressman Sanders, you will recall that some years ago,

I believe in 1998, that VA announced an open-ended what we call

RFP, request for proposals, DOD calls BAA, broad area announcement, indicating our receptivity to treatment trials of any novel

therapy agent. That RFP is still active, but I will concede that we

perhaps should reannounce it just to make sure that those that

need to know are reminded that that is still active.

Mr. SANDERS. What I am asking, Dr. Feussner, you know what

I’m asking, are we welcoming in the door people who have controversial ideas who are not quote unquote, peer reviewed by folks

who have not given us any information in 10 years? Are you having

the courage to go out and say, look, people may—I may be attacked

for going to somebody who is controversial, but I’d rather be attacked for going to somebody who is controversial and may contribute something to our knowledge rather than go back to the same

old folks who 20 years from now tell us we don’t know the cause.

Are you prepared to do that, to take the heat?

Mr. SHAYS. You recognize that’s a loaded question, don’t you?

Mr. SANDERS. You understand where I am coming from?

Dr. FEUSSNER. Sir, I certainly do understand where you’re coming from, and what I would say is I think our actions do speak to

that issue, and that is, that we have followed up with larger scale

research, looking at reasonable testable hypotheses, specifically

with regard to Dr. Hayley. Dr. Hayley published preliminary work

in the Journal of the American Medical Association exploring possible definition for a number of Gulf war syndromes. You will recall

that very early on after that work is published, I had the opportunity to testify before the committee. I think that Dr. Sox’s point

is well taken. Dr. Hayley studied a small number of study subjects.

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His response rate in the initial study, even in a highly selected patient population, was only 40 percent. There were no controls.

But the observation bore attention, OK. I mean, he put something on the table. Now, the follow-on to that is it’s—as you know,

because we’ve talked about this a lot, scientific process. It’s not important for the initial investigator to replicate his or her own work

but for other scientists to do that.

We have supported four follow-on studies looking at those syndromes, three in the United States and one in the United Kingdom.

The United Kingdom was published in the Journal Lancet by Dr.

Wesley. We have the Naval Health Research Center in San Diego.

We have the CDC study of Fukuda and colleagues, and we have

the Iowa study just recently published this year in the American

Journal of Medicine. None of those studies is able to replicate Dr.

Hayley’s initial observations in terms of finding the kinds of unique

syndromes that Dr. Hayley found in his preliminary hypothesisgenerating research.

What we are left with in that effort is, one, we have followed on

the effort to replicate the work. We have not been able to replicate

the work at this point in time. But actually, there is yet another

study that we are supporting in collaboration with researchers at

GW using the same analytical strategy, etc.

Mr. SANDERS. What you’re saying is you’ve taken Hayley’s work

seriously, you’re putting money and resources into trying to replicate it, at this point that has not happened.

Dr. FEUSSNER. In that particular one we have not been able to

replicate the work.

With regard to the work on the structural brain disease, we have

talked about that at the hearing in February, and we have a number of studies ongoing that are looking also at structural brain disease. The most—and so, an effort is underway to try to explain,

replicate, extend that observation. The most recent observation, actually I haven’t had an opportunity to go over in detail myself. It

is quite recent, within the last week or so, looking at

neurotransmitters, chemicals in the brain that tell other parts of

the brain what to do, and since the brain tells the rest of the body

everything to do, very important, called—dopamine is the chemical.

We haven’t taken a hard look at that yet, but what I will tell

you, the worry here has to do with Parkinson’s disease, and independent of this issue with Hayley, VA is currently reviewing, as a

result of another RFP VA is currently reviewing, and hopefully

later this calendar year will fund up to six major centers, research

centers devoted to the study of Parkinson’s disease and movement

disorders. We call them PADRECC’s, Parkinson’s Disease, Research Education and Clinical Centers, modelled after the VA-funded geriatric centers. So that we will have the capacity, I believe,

within—at least within VA, certainly within the broader scientific

community, to follow on those observations.

So I think what I’m doing, Congressman, is giving you a long answer to a short question.

Mr. SANDERS. It’s a good answer. Let me ask you this and I’ll

give the mic back to the chairman. I remember, sometimes there

are instances where things occur and you never forget them, but

I remember meeting with many Vermont veterans who are sufferVerDate 11-MAY-2000 09:13 Sep 25, 2001 Jkt 000000 PO 00000 Frm 00075 Fmt 6633 Sfmt 6633 C:\DOCS\74864.TXT HGOVREF1 PsN: HGOVREF1
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ing from Gulf war illness, and one of the symptoms, many of them

relayed to me is when they were exposed to perfume or detergent

smells or other chemical presence, gasoline fuels, they would become sick, which suggested to me that we’re looking perhaps at

what might be called multiple chemical sensitivity, and as you

know, I am sympathetic to the work that Dr. Claudia Miller and

others are doing. Can you tell us a little bit about some of the research the VA may or may not be doing in following up on the

issue of multiple chemical sensitivity in Gulf war illness?

Dr. FEUSSNER. I think what I would have to say, Congressman

Sanders, is that the last time you asked that question, I don’t have

much of a different answer to give you this time. We have about

half a dozen or so research projects looking at the issue of multiple

chemical sensitivity. They’re currently active. In a response to a

meeting that we had with you in your chambers some time ago, we

invested a considerable amount of energy trying to forge a collaboration between Dr. Miller and VA investigators, both in San Antonio and, as I recall, in Tucson with Dr. Iris Bell, who’s testified before you in the past.

We have also indicated, as you know, the interest in explicitly

looking at prospective treatment trials and also, as you know, some

of the difficulty in pursuing those ideas aggressively relate to the

infrastructure that is required in order to do the research. It’s not

as——

Mr. SANDERS. Let me just jump in and bring this to the point.

To the best of my knowledge the U.S. Government, despite the

widespread feeling of many physicians, certainly not all, that multiple chemical sensitivity is a serious disease not only facing Gulf

war veterans but the American population. Correct me if I’m

wrong, Dr. Feussner, but I don’t know that the Veterans Administration or DOD owns what is called an environmental chamber

where we can do scientific studies regarding treatment of multiple

chemical sensitivity. Is that a fair statement? I know we’re trying

to get funding for it, but it’s beyond my comprehension that the

U.S. Government doesn’t own one of those units quite yet.

Dr. FEUSSNER. I think I answered that question the last time

and said yes, the U.S. Government does own these facilities. I am

searching my hard drive to find those data, sir. What I can tell you

is the VA does not. I can’t recollect about DOD. I do recollect that

EPA has such laboratories in the research triangle in North Carolina, and I do believe that DOD has several of these facilities, but

I cannot remember the last time I looked this up. I’ll have to—— Mr. SANDERS. Short term memory loss, multiple chemical sensitivity, there it is. Thank you very much, Mr. Chairman.

Mr. SHAYS. I’m just going to have a slight advertisement for a

committee meeting that we’re having next week on Gulf war illnesses. The Royal British legion formed a Gulf veterans group

some years ago to provide a focus for Gulf veterans issues. It is

made up of Gulf veterans, parliamentarians, representatives of

VSOs and service welfare organizations and medical and scientific

advisers. A delegation from the Gulf war veterans group visited the

United States in July 1995 and similar group intend to visit Washington, DC, from October 2nd to 6th. We will be meeting with a

group on Wednesday, October 4th from 10 a.m. in room 2154 with

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Lord Morris, the distinguished parliamentarian, with a background

in trades and union members; Colonel Terry English, director of

welfare at the Royal British legion; Kathy Walker, director of welfare, the Soldiers, Sailors and the Airmen Families Association; Dr.

Norman Jones, medical adviser, Royal British Legion; Mr. John

Nichol, author, Gulf war veteran and ex-POW; Professor Malcolm

Hooper, scientific adviser, Gulf Veterans Association.

Let me first ask you, Dr. Brown, is there anything that you

would want to respond to Mr. Sanders, any comment or observation?

Dr. BROWN. No. When it comes to research issues, Jack is your

man.

Mr. SHAYS. OK. Well, I’ll ask either one of you, how many of the

83 research projects—there are 192 research projects in Gulf war

veterans illnesses at various stages of completion, 83 have been

completed, and I want to know of the 83 projects completed, how

many have been published and peer reviewed?

Dr. FEUSSNER. I’ll have to get that information for you, Congressman Shays.

Mr. SHAYS. Could someone else give us that?

Dr. FEUSSNER. We don’t have that off the top of our heads.

Mr. SHAYS. How many completed projects involve sarin and have

been published and peer reviewed?

Dr. FEUSSNER. I will have to get those data for you as well.

Mr. SHAYS. How many involving PB?

Dr. FEUSSNER. How many are already finished and published?

Mr. SHAYS. Published and peer reviewed.

Dr. FEUSSNER. I think it’s approximately six to eight.

Mr. SHAYS. OK. How many as relates to DU, depleted uranium?

Dr. FEUSSNER. I would say, again, probably six or seven.

Mr. SHAYS. And how many involving vaccines?

Dr. FEUSSNER. I don’t know the answer to that question. I’ll have

to get you those data.

Mr. SHAYS. I know you will do that. I do want to ask the questions though. What yet unpublished studies are underway which

would address the long-term effects of exposure to these toxic

agents?

Dr. FEUSSNER. Well, there are quite a large number of projects

that are still ongoing. For example, in PB, the total number of

funded projects is about 30. With regard to chemical weapons,

there are about 22. The DU focus at the moment in humans is

pretty much limited to followup of the friendly fire soldiers in Baltimore, and there are a small number of probably four or five animal studies in DU.

Mr. SHAYS. OK.

Dr. FEUSSNER. Did I answer all the parts?

Mr. SHAYS. Well, it’s a pretty extensive question. You said there

are many. Do you think, in fact, there are many?

Dr. FEUSSNER. Yes.

Mr. SHAYS. OK. And by ‘‘many,’’ you would give a number of

what approximately?

Dr. FEUSSNER. For which issue?

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Mr. SHAYS. I just asked what yet unpublished studies are underway which address the long-term effects of exposure to these toxic

agents which involve those four agents.

Dr. FEUSSNER. Yes, I could do the math real quick.

Mr. SHAYS. Some you don’t know. You said many. Are we talking

20, are we talking 80? I mean, what are we talking about?

Dr. FEUSSNER. In terms of total number of projects I think we’re

talking about in the ballpark of perhaps 100.

Mr. SHAYS. And you will get back to us and document those?

Dr. FEUSSNER. You not only want the number of projects, you

want the number of projects, those finished and the publication?

Mr. SHAYS. Right.

Dr. FEUSSNER. Yes, sir, I’ll have to get you that data.

[The information referred to follows:]

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Mr. SHAYS. I understand. According to a January 2000 General

Accounting Office report on Gulf war illnesses, the Department of

Veterans Affairs stated that the research working group, which I’ll

refer to as RWG, would, ‘‘establish a date in fiscal year 1999 or fiscal year 2000 for publishing its assessment of progress toward addressing the 21 research objectives that’s identified in 1995.’’ When

will the research group assessment’s of progress toward addressing

the 21 research objectives be published?

Dr. FEUSSNER. We’ve actually made a substantial progress in

this area, Congressman. We discussed this at our last hearing, and

the majority, 11 of the 15 papers that we had commissioned at that

time are in draft form. We have worked with a very prestigious

medical journal, and the editor of that journal to not only produce

these papers for the Congress, but to produce these papers for the

larger community. We have a commitment from—— Mr. SHAYS. Isn’t that the key? The larger community is complaining to us that they’re not getting access to this research.

Dr. FEUSSNER. Yes, I think that is the issue.

Mr. SHAYS. To date, we don’t really have any published.

Dr. FEUSSNER. The papers have received preliminary review by

the editor of the journal already, but the next step for the manuscripts will be to go out to independent experts to get an additional

episode of review. I would hope that the manuscripts would be published electronically after the 1st of the year, perhaps the second

quarter of fiscal year 2001. We have discussed with the editor the

possibility of publishing the manuscripts electronically while we

await for the manuscripts to appear in print. It is my hope that

we can have the manuscripts in electronic format between January

and March and in print as a special supplement, probably between

March and May.

Mr. SHAYS. So basically you’re in fiscal year—— Dr. FEUSSNER. I am in fiscal year 2001.

Mr. SHAYS. Right. You’re really at the end of that fiscal year— well, it starts in September.

Dr. FEUSSNER. Yes.

Mr. SHAYS. Not in the end. You’re kind of in the middle. What

is the research working group’s role with the Military and Veterans

Health Coordinating Board?

Dr. FEUSSNER. Well, the research working group, the Military

and Veterans Health Coordinating Board has three subcomponents

underneath the executive, the executive leader. The research is one

of those three subgroups. Within the research group, there will

really be two primary foci. The first will be the Gulf war research

activities, since 60 percent of these projects are incomplete. As a

matter of fact, I think just in fiscal year 1999 and 2000, we have

launched 42 additional studies.

The second component of the research activity within the military and veterans coordinating board will deal more specifically

with the generic issue of post deployment health and three major,

at least three major interests within that area will include an effort

to improve the situation with regards to systematically obtaining

baseline data so that after subsequent deployments, we will systematically have baseline data; systematically collect data through

time on the soldiers which would also require an integration and

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a merging of the VA and DOD data bases; and then increasingly

apply research activities or research results became available that

could document exposures.

Mr. SHAYS. To what extent will the absorption of the RWG into

the new Military and Veterans’ Health Coordinating Board diminish the RWG’s focus on Gulf war illnesses, veterans illness research?

Dr. FEUSSNER. Well, it is my intent that it not diminish the focus

on Gulf war veterans’ illness, and given the incomplete status of

the formal research and the emerging research that is going to be

initiated with regards to post deployment health issues, I would

imagine over the next period of time, say the next 3 or 4 years,

that the dominant research effort within that larger group will continue to be Gulf war research projects.

Mr. SHAYS. I’m going to try to finish because Mr. Sanders and

I need to vote, but to what extent is the new board fully operational?

Dr. FEUSSNER. The new board has already engaged in a series

of meetings several weeks ago. All leaders of the boards and a larger community of involved participants had a 2-day retreat at Andrews Air Force Base. We are completing the formal strategic planning process for the coordinating board and have identified the

three leaders of the three major subgroups.

Mr. SHAYS. So you haven’t started being operational yet but

you’re at that point?

Dr. FEUSSNER. I think that’s fair.

Mr. SHAYS. According to a General Accounting Office, GAO, January 2000 report on Gulf war illnesses, questions remain regarding, ‘‘how many veterans have unexplained symptoms and whether

those who have received care in VA facilities are getting better or

worse.’’ What progress has been made toward developing a system

of tracking clinical efforts and treatment outcomes among sick Gulf

war veterans?

Dr. BROWN. I’ll take a stab at that. We have a number of ways

in which we track the health of Gulf war veterans. The Institute

of Medicine recently released a report that I’m sure you’re aware

of which made the point that if we really want to study the longterm health consequences of service in the Gulf war, that is, your

question whether veterans are getting better or worse are staying

the same, that you need to set up appropriate longitudinal studies

to follow those populations.

We have a couple of studies already underway that are looking

at subgroups of veterans. Dr. Feussner mentioned the Iowa study.

I also want to make this committee aware, we just published a report just last April on a study that was looking at the health of all

Gulf war veterans, called National Veterans Health Survey, looked

at the health of all Gulf war veterans across the board. I can provide the committee with a copy of the report. It found similarly to

other studies that when you look at a national survey of all Gulf

war veterans, that you find greater rates of symptoms, greater

rates of illnesses in terms of self-reported symptoms, and a number

of other findings. It is unique in that it’s the only study that looks

across the board at all veterans, and it’s our intention—it’s my office’s intention to follow that study up in a longitudinal sense.

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Mr. SHAYS. Basically though what I am hearing you say, we really don’t have a system yet to track.

Dr. BROWN. I think we do have some initial data.

Mr. SHAYS. You have data but you don’t have a system, you are

not tracking all these.

Dr. BROWN. The system that would do that for us would be a longitudinal study.

Mr. SHAYS. ‘‘Would be’’ is not—— Dr. BROWN. We don’t have that in place yet.

Mr. SHAYS. This is all. And finally, what is the Department of

Veterans Affairs doing about obtaining access to classified information? This really galls me that we don’t have information. I mean

we had the DOD who said our troops weren’t exposed to offensive

chemical exposure, and yet they were exposed to defensive chemical exposure. So I want to know what the VA’s doing. Are we just

lying back or are we trying to get this information?

Dr. FEUSSNER. In the research mode, we have not made efforts

to get classified information. Two comments. The first is that my

understanding is that the IOM will gain access at least to unpublished information about anthrax research in a new study that is

being undertaken by them, and that with regard to CW, chemical

weapons, issues that both the Presidential Advisory Commission

and the Senate Veterans Affairs Investigating Committee had access to that classified information.

Mr. SHAYS. The challenge we do have is the IOM did not have

access to certain information.

Dr. FEUSSNER. That is correct.

Mr. SHAYS. And I think it galls both me and Congressman Sanders that that’s not made available, and it would strike me that anybody who’s worked with our veterans would demand the same, so

I just plead with you to be a little more aggressive. We will. We’d

like you to be as well. I think what we’ll do, I usually invite comments, if you have a 30 second comment either one of you, I’d welcome that, but we need to get voting. Any comment?

Dr. FEUSSNER. No, sir.

Mr. SHAYS. Thank you both for being here.

[Whereupon, at 12:05 p.m., the subcommittee was adjourned.]

[Additional information submitted for the hearing record follows:]

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