U.S. GOVERNMENT PRINTING OFFICE

67–151 CC WASHINGTON : 2000

GULF WAR VETERANS’ ILLNESSES: THE CURRENT

RESEARCH AGENDA

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

FEBRUARY 2, 2000

Serial No. 106–147

Printed for the use of the Committee on Government Reform

(

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

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

LISA SMITH ARAFUNE, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL

RELATIONS

CHRISTOPHER SHAYS, Connecticut, Chairman

MARK E. SOUDER, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH-HAGE, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

LAWRENCE J. HALLORAN, Staff Director and Counsel

ROBERT NEWMAN, Professional Staff Member

JASON CHUNG, Clerk

DAVID RAPALLO, Minority Counsel

(III)

C O N T E N T S

Page

Hearing held on February 2, 2000 ......................................................................... 1

Statement of:

Bell, Iris, M.D., Ph.D., associate professor, program in integrative medicine, University of Arizona College of Medicine; Claudia Miller, M.D.,

M.S., assistant professor, environmental and occupational medicine,

University of Texas Health Science Center; Howard Urnovitz, Ph.D.,

scientific director, Chronic Illness Research Foundation .......................... 107

Chan, Kwai, Director, Special Studies and Evaluations Group, General

Accounting Office, accompanied by Sushil Sharma, Ph.D., Assistant

Director, and Betty Ward-Zukerman, National Security and International Affairs Division .............................................................................. 7

Feussner, John, M.D., Chief Research & Development Officer, Department of Veterans Affairs; John Mazzuchi, Ph.D., Deputy Assistant

Secretary for Health Affairs, Department of Defense; Robert Foster,

Ph.D., Director, Biosystems, Department of Defense; Lt. Gen. Dale

Vesser, USA (Ret.), Deputy to the Special Assistant for Gulf War Illnesses, Department of Defense; and Drue Barrett, Ph.D., Chief, Veterans’ Health Activity Working Group, Centers for Disease Control &

Prevention ..................................................................................................... 34

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

Barrett, Drue, Ph.D., Chief, Veterans’ Health Activity Working Group,

Centers for Disease Control & Prevention, prepared statement of .......... 79

Bell, Iris, M.D., Ph.D., associate professor, program in integrative medicine, University of Arizona College of Medicine, prepared statement

of ..................................................................................................................... 111

Chan, Kwai, Director, Special Studies and Evaluations Group, General

Accounting Office, prepared statement of ................................................... 9

Chenoweth-Hage, Hon. Helen, a Representative in Congress from the

State of Idaho, prepared statement of ......................................................... 6

Feussner, John, M.D., Chief Research & Development Officer, Department of Veterans Affairs, prepared statement of ....................................... 37

Foster, Robert, Ph.D., Director, Biosystems, Department of Defense, prepared statement of ........................................................................................ 58

Mazzuchi, John, Ph.D., Deputy Assistant Secretary for Health Affairs,

Department of Defense, prepared statement of ......................................... 50

Miller, Claudia, M.D., M.S., assistant professor, environmental and occupational medicine, University of Texas Health Science Center, prepared

statement of ................................................................................................... 123

Urnovitz, Howard, Ph.D., scientific director, Chronic Illness Research

Foundation, prepared statement of ............................................................. 136

Vesser, Lt. Gen. Dale, USA (Ret.), Deputy to the Special Assistant for

Gulf War Illnesses, Department of Defense, prepared statement of ........ 74

(1)

GULF WAR VETERANS’ ILLNESSES: THE

CURRENT RESEARCH AGENDA

WEDNESDAY, FEBRUARY 2, 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

2154, Rayburn House Office Building, Hon. Christopher Shays

(chairman of the subcommittee) presiding.

Present: Representatives Shays, Blagojevich, Tierney, Allen,

Sanders, and Schakowsky.

Also present: Representative Metcalf.

Staff present: Lawrence Halloran, staff director and counsel;

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

David Rapallo, minority counsel; Earley Green, minority assistant

clerk; and Chris Traci, minority staff assistant.

Mr. SHAYS. I would like to call this hearing to order.

In November 1997, after extensive hearings on Gulf war veterans’ illnesses, this committee found, quote, current approaches to

research, diagnosis and treatment unlikely to yield answers to veterans’ life-or-death questions in the foreseeable, or even far distant,

future. We called for an aggressive, well-coordinated research effort, independent from constitutional inertia and bureaucratic selfinterest, to support the goals of accurate diagnosis, effective treatment and fair compensation for all Gulf war veterans.

Since 1997, the Departments of Defense, Veterans Affairs, and Health and Human Services, have spent more than $121 million

trying to meet basic research goals to better understand the extent,

the causes and the cures of Gulf war veterans’ illnesses. More than

150 studies have been funded. The Office of the Special Assistant

for Gulf War Illnesses contracted for additional studies and surveys.

To assess the productivity of this substantial research program,

we asked the General Accounting Office, GAO, to examine the extent to which the agenda is being managed effectively, efficiently

and with an appropriate sense of urgency. Their findings validate

our initial assessment and confirm our worst fears about the pace

and prospects of the search for answers for sick Gulf war veterans.

The group charged to coordinate the research effort has not even

assessed how well the current portfolio is meeting established objectives. More than half of DOD’s total expenditures took place outside the multi-agency coordination framework designed to focus reVerDate 11-MAY-2000 08:58 Dec 27, 2000 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCS\67151.TXT HGOVREF1 PsN: HGOVREF1
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search and avoid costly duplication. Nine years after the Persian

Gulf war, basic questions remain unanswered. We still don’t know

how many veterans are suffering unexplained illnesses. We still

don’t know how their illnesses progress, and we still don’t know if

they’re getting any better.

We are, of course, mindful of the incremental nature of scientific

inquiry. Many Gulf war veterans’ illnesses are difficult to diagnose,

can only be treated symptomatically, and may be impossible to associate with a wartime exposure or event. But patience is no excuse

for a lack of vigilance. We must be certain all Federal research into

Gulf war illnesses is well designed, vigorously pursued, and keenly

focused on the most promising hypotheses.

Our witnesses today represent the GAO, the Federal departments and agencies conducting Gulf war studies, and private researchers who have made some of the most significant findings in

this area, often without Federal funding. We look forward to their

testimony. And I might say, given the number of witnesses, it will

be more testimony than questions.

Mr. SHAYS. My colleague, Mr. Sanders.

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

you for all of your efforts over the last several years.

I will be brief. I think there’s some good news, and I think there

is some bad news out there. The good news is that when you and

I and others began bringing this issue to the floor because we were

responding to the pleas of thousands of Gulf war veterans all over

this country who told us they were hurting, who told us when they

walked into the VA hospital they were ignored or at best told they

had a psychological problem, I think we can say fairly that, since

that point, we have made some progress. That’s the good news.

The bad news, as you’ve just indicated, that after all the large

amounts of money that the government has spent on Gulf war research, the truth of the matter is that today we do not have a

treatment for the close to 100,000 veterans who are hurting. We do

not fully understand the cause of the problem.

What is the good news? The good news is that, over the last

number of years, there have in fact been a number of studies which

we hope are bringing us closer to the truth. And I will just point

out a few.

Right now—and I see Dr. Jack Feussner here, and I’m glad he

is here—there is an important study being conducted at the VA

hospitals throughout this country testing a hypothesis. Microplasma infection may in fact be one of the causes of Gulf war illness, and a treatment protocol is being developed. That is a step

forward.

Just the other day, we read in the papers that at Tulane University it appears that Gulf war veterans who are suffering from a variety of illnesses have antibodies to squalene in their blood. This

may tell us something.

A couple of months ago, we heard from the Veterans’ Administration. Despite, Mr. Chairman, all that we had heard in the past that

pyridostigmine was ever so benevolent, it turns out that a study

came out from them that says that may not be the case, and

they’re not going to rule that out as a cause of Gulf war illness.

We have studies that suggest that veterans who are susceptible for

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multiple chemical sensitivity may in fact have higher incidences of

Gulf war illness than others. There are studies coming out of Texas

that suggest that people who are suffering from Gulf war illness

now have determinable brain damage that can be objectified and

seen. There are a number of other studies out there as well.

Now, my conclusion is that some serious scientists in this country are making some serious progress. I am pleased to see that the

VA is beginning, in terms of the microplasmic study, to begin to

move forward, but clearly they are not doing it enough and fast

enough.

My own hope, Mr. Chairman, is that we will be supportive of

those people in academia who have begun to make some breakthroughs and give them the support that they need. The truth of

the matter is that, from World War II to today, whether it is radiation illness, whether it is Agent Orange, whether it is Gulf war

illness, the sad truth is that the U.S. Government has not treated

veterans with the dignity and the care that they deserve. And I

would hope that we support those men and women who put their

lives on the line who are hurting today by supporting that research

out there which is leading us closer to understanding the cause of

this terrible problem and developing an effective treatment.

Mr. SHAYS. Thanks.

Before calling on the first panel, I would also like to welcome Mr.

Metcalf, who has been very interested and active in this issue and

welcome any statement you would like to make for the committee

and also appreciate your participation in the hearing.

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

Thank you, Congressman Sanders, for signing my letter and for

your testimony today.

I would like to thank the other members of the subcommittee for

allowing me to participate in this hearing and express my concerns

regarding the Federal Government’s research efforts into the

causes and treatment also of Gulf war illnesses. I am deeply grateful that you have remained steadfast in your efforts to try to find

the truth and to require accountability.

This hearing is focused on the fact that the Federal Government

has spent more than $133 million in research to determine the

causes of Gulf war illnesses and to find treatments. I applaud this

committee for asking what American taxpayers got for their money,

$133 million. Sadly, however, I must state that, in my mind, far

too little has been accomplished to actually help veterans suffering

from Gulf war illnesses.

I would like to draw the subcommittee’s attention to a new piece

of research that could make a significant contribution in addressing

the health issues of those suffering from Gulf war illnesses. The

paper is ‘‘Antibodies to Squalene in Gulf War Syndrome,’’ is an article that has just been published in the February 2000, issue of

Experimental and Molecular Pathology. Today, I am providing copies of this important study for members of the subcommittee.

Joined by several colleagues, yesterday I wrote to Secretary of Defense William Cohen asking for an objective analysis of this research.

This peer-reviewed article found anti-squalene antibodies in a

very high percentage of sick Gulf war-era veterans. As a biomarker

4

for the disease process involved in Gulf war illnesses, the assay/

blood test cited in the study could provide a vital diagnostic tool.

I hope this will quickly lead to improved medical treatments for

many who are suffering.

Many who have heard about this issue are anxious to understand

the ramifications, especially those veterans and their families

whose lives sadly have been directly affected. We certainly acknowledge the need for further research. However, that should not

preclude a vigorous examination of the immediate benefits this

study may provide medical practitioners treating those who suffer

from Gulf war illnesses.

The House-passed version of the fiscal year 2000 defense appropriations bill included report language instructing the Department

of Defense to develop and/or validate the assay to test for the presence of squalene antibodies. This action was taken in response to

DOD unwillingness to cooperate with the March 1999, General Accounting Office recommendation. It is my firm belief that the integrity of the assay was the first step in finding answers.

Now that this study has been peer-reviewed and published, we

need to take the next step and build on established science. An internal review by the same individuals within the DOD who were

unwilling to cooperate for months does not constitute the kind of

science that those who sacrificed for this Nation deserve. Given the

published article, it seems prudent to use the assay if it could help

sick Gulf war veterans. At this critical juncture, I fervently hope

that Secretary Cohen agrees. All agencies charged with helping our

Gulf war era veterans should closely review this now peer-reviewed

study.

Mr. Chairman, I want to thank you again for your leadership

and look forward to continuing to work with you to find answers

and the best in medical treatment for our Gulf war era veterans.

Thank you.

Mr. SHAYS. Thank you.

We’ve been joined by two other Members—Ms. Schakowsky from

Illinois—and welcome any statement you would like to make.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

I just wanted to say that it was my honor to join Congressman

Metcalf in that letter to Secretary Cohen asking for an objective

analysis of the article, the study, the Antibodies to Squalene in

Gulf War Syndrome, and certainly hope that we can do everything

possible to quickly lead to improved medical treatments for the

many, many who are suffering.

Mr. SHAYS. Thank you.

Mr. Allen, nice to have you here.

Mr. ALLEN. Mr. Chairman, I’m happy to be here. I want to thank

you for holding these hearings. If I have other comments, I’ll add

them later. Thank you.

Mr. SHAYS. Thank you.

We have three panels. The first panel we have one speaker accompanied by someone else as well, and we have on the second

panel five speakers and in the third panel four. The staff will pay

for this later. But we will be very attentive; and it will, in fact, be

helpful. There’s really no way to get around it. We do need to hear

5

from each and every one of you, but we will have to give deference

to the testimony more than to the questions.

Our first panel is Mr. Kwai Chan, Director of Special Studies

and Evaluations Group, General Accounting Office, accompanied by

Dr. Sushil Sharma, Assistant Director from the same group. And

we are also going to have someone else as well, Dr. Betty WardZukerman from the GAO National Security and International Affairs Division.

If you would all three stand and I’ll swear you in.

[Witnesses sworn.]

Mr. SHAYS. The answer is yes on the part of all four.

Would you identify yourself for the record as well?

Mr. WOODS. My name is William Woods. I’m with the Office of

the General Counsel of the General Accounting Office.

Mr. SHAYS. I appreciate your being sworn in in case we need to

rely on you for an answer to a question. Thank you.

I ask unanimous consent that all members of the subcommittee

be permitted to place an opening statement in the record and that

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

[The prepared statement of Hon. Helen Chenoweth-Hage follows:]

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Mr. SHAYS. I ask further unanimous consent that all witnesses

be permitted to include their written statement in the record. Without objection, so ordered.

Mr. Chan, you have the floor.

STATEMENT OF KWAI CHAN, DIRECTOR, SPECIAL STUDIES

AND EVALUATIONS GROUP, GENERAL ACCOUNTING OFFICE,

ACCOMPANIED BY SUSHIL SHARMA, PH.D., ASSISTANT DIRECTOR, AND BETTY WARD-ZUKERMAN, NATIONAL SECURITY AND INTERNATIONAL AFFAIRS DIVISION

Mr. CHAN. Mr. Chairman and members of the subcommittee, it

is my pleasure to be here today—— Mr. SHAYS. I’m going to remind you to put that mic down a little

bit farther and turn it that way a little bit.

Great, thanks.

Mr. CHAN. It’s my pleasure to be here today to discuss the results of our work evaluating the outcome of Federal investment on

Gulf war illnesses research conducted by VA, DOD, and HHS.

Before I begin, Mr. Chairman, I would like to go back to our

June 1997, report and repeat two of our major findings. First, we

found that neither DOD nor VA knew whether ill Gulf war veterans had gotten better or worse since they were first examined. Second, we reported that the ongoing epidemiological research would

not provide any meaningful information regarding the causes of

veterans’ illnesses.

Today I regret to report that little has changed. In spite of considerable additional expenditures, we still do not know whether our

Gulf war veterans are any better or worse off since they were first

examined. Basic questions about the causes and treatment of their

illnesses still remain unanswered, and these agencies still have not

adopted one or more case definitions that might focus Federal research efforts.

Let me discuss our results. I have four findings to report.

First, DOD, VA, and HHS spent over $121 million on research

investigations in fiscal year 1997 and 1998. DOD efforts account for

over 90 percent of that total. Over half was spent by DOD’s Office

of the Special Assistant for Gulf War Illnesses, which I will refer

to as OSAGWI.

Our second finding concerned the results of these expenditures.

In this regard, we have three observations.

No. 1, the Persian Gulf Veterans’ Coordinating Board’s Research

Working Group has not published any assessment of the extent to

which its specific research objectives have been satisfied. We recommended and the agency agreed that such an assessment should

be published by the end of this year.

No. 2, most research is still ongoing. By mid 1999, of the 151

projects funded by the Federal Government, 30 percent had been

completed. While OSAGWI has received 19 of the 20 reports due

from its contractors, it has publicly released only 6 of them. Of

these reports, 14 had remained in draft or in review status for a

year or longer.

No. 3, even basic questions regarding the number of veterans

with unexplained symptoms and the causes and progression of the

illnesses remain unanswered. In addition, the Research Working

8

Group has not endorsed any case definitions that might focus Federal research efforts. Most of the federally funded epidemiologic

studies have been descriptive and not designed to test specific

hypotheses about causes of veterans’ illnesses.

Our third finding pertains to the activity of OSAGWI. We found

its research activities were not effectively coordinated with the Research Working Group. The rationale given to us was based on semantic distinctions. Both VA and DOD tell us OSAGWI’s activities

involve investigations rather than research and therefore are not

subject to oversight or monitoring by the Research Working Group.

This weak coordination resulted in some duplication of effort. For

instance, OSAGWI, VA, and HHS commissioned separate reviews

of the literature on the health effects of depleted uranium. In addition, OSAGWI and VA have funded RAND and the National Academy of Sciences respectively to perform literature reviews regarding potential Gulf war exposures.

Finally, with regard to the management of contracts supporting OSAGWI, we found that task orders worth over $20 million were

awarded improperly, and the office discouraged competition for another task order by specifying a preferred vendor. Because

OSAGWI is likely to continue to spend a significant part of its

budget on support contracts, it needs to ensure that its contracts

fully comply with applicable laws and regulations.

Mr. Chairman, this concludes my statement; and I would be

happy to answer any questions you may have.

Mr. SHAYS. Thank you.

[The prepared statement of Mr. Chan follows:]

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Mr. SHAYS. The chair recognizes Mr. Sanders.

Mr. SANDERS. Thank you, Mr. Chairman.

Mr. SHAYS. I’m sorry. I do want to recognize Mr. Blagojevich.

Mr. SANDERS. Mr. Chan, thank you for your testimony.

Let me ask you a question. What concerns me is that a number

of studies have been done, a lot of money has been spent. In your

judgment does—do the people who are funding these studies now

in the VA and the DOD and the relevant committees, can they

come before us today and say, look, the good news is that we are

making some progress here. We are looking at this. This theory has

now been disregarded. We know this, we know that. Or are we

going to continue to see a myriad of studies all over the place leading us nowhere?

The question is, 9 years later, where are we? Where are we going

to go? I’ll ask representatives of the VA and DOD this question in

a little while.

But what have we learned? It doesn’t do us any good to have a

million studies if we don’t have any conclusions. What have we

learned? It sometimes sounds nice or it is a good press release. We

are spending $5 million for another study. What have we learned?

Where are we going? What are we trying to prove?

So what I’m asking you is, what hypotheses are out there based

on all of these studies? Where do you recommend that we continue

to go? What theories should we be pursuing?

It seems to me that in recent years, as I said a moment ago,

there have been what appears to those of us who are laymen some

breakthroughs. Are those being pursued?

Now, a couple of years ago, before this committee, we were told

by many of the VA and the DOD people that the problem was

‘‘stress.’’ Is that still a hypothesis that is being advanced or have

we gone beyond that?

Bottom line is, after all of this money, where are we today?

Where do you think we should be going?

Mr. CHAN. Should I answer question one or two?

Mr. SANDERS. Both.

Mr. CHAN. We said that there are over 151 of these projects and

that Federal research began back in 1994, so if you look at it from

that perspective, we are generating probably two projects a month

over this period. So we have lots of work in progress.

And, initially, I think, we started very slowly. I’m talking about

the agencies’ acceptance that in fact the illnesses are out there. By

the time they accepted it, I think they had attached to a specific

hypothesis, which was stress, to the exclusion of any other kinds

of hypotheses. When Khamisiyah came along, then it became another set of hypotheses about low-level exposure to chemicals and

then suddenly have a whole set of different possible causes or

agents. And so now what you see is really almost like fruit trees

with lots of fruit hanging and we are picking one or the other.

I think you’re right that, in a certain way, we reached a certain

stage. Now there are, in fact, some scientific results that show

promise; and we are beginning to find that—in fact, I think CDC

had found that, through its Pennsylvania study—that there are potentially some broad case definitions to allow people to at least

focus on where the efforts should be.

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But generally, I think, a different way to answer your question,

is that the impression from the outside is that the agencies are

very slow in accepting that, in fact, they need to investigate in this

area, that the pursuit of science is the end goal of this research,

not treating the soldiers. So in 1997 when we testified before you,

our comment was that in fact a lot of projects are focused on

epidemiolog study and there are potential problems in gathering

that information because of difficulty in recall and specifying locations and exposure and the problem of not having a case definition.

Mr. SANDERS. Let me just reiterate, Mr. Chan, and I’ll end at

that.

If we had before us today a panel of experts dealing with AIDS,

for example, they could tell us over the last 10 years what has been

discarded, what has been accepted, and where they are going and

where they hope to be in the next 5 years. I have the unfortunate

feeling, the unpleasant feeling that that is not the case with Gulf

war illness, that we may well hear the same testimony, well, we’re

not quite sure. It may be stress. It may be not. Blah, blah, blah.

And after $120 million there will not be somebody from the VA or

DOD to say, well, we have discarded this theory. It is not stress,

that is for sure, because of a, b, and c. We’re narrowing in on this.

We’ve made some progress on that. We’re going to put more money

into that, but that’s no longer relevant.

Is my statement a fair statement?

Mr. CHAN. I believe so. I think initially DOD basically stated

that there were no problems out there; and when we found there

were some problems, they said, well, they are not unique. When we

found there are unique things have been found then DOD says we

need more research. That’s the paradigm you have.

If I step back from it, my question would be not so much are

these successful research projects but rather ‘‘now what?’’ Where do

we go from here? At what point do we decide to emphasize moving

on to diagnosis and treatment because the research really doesn’t

touch the soldiers in the way you intended.

Mr. SANDERS. I’m concluding by saying we hope the result—one

clinical test that is out there is testing the mycoplasmic theory. The

VA is doing that. We hope if that test turns out to be positive, we

will in fact have a treatment. Other than that, I’m not quite sure

I know what the VA and DOD are doing.

Mr. Chairman, thank you; and, Mr. Chan, thank you.

Mr. SHAYS. Ms. Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

Being new to this panel, I learn things every day that astonish

me. That of the nearly 700,000 veterans of the Gulf war, I understand from our committee memo, 100,000 or more have been complaining of illnesses. And we hear about $121 million and all of

these committees and 9 years. And so let me ask a couple of I think

pretty obvious questions that come to mind.

In one part of your testimony, you said there is no government

research specifically directed toward understanding the progress of

these illnesses over time. What do you mean by that?

And in another part of this, the testimony, you mentioned an

HHS project to assess the persistence and stability of veterans’

21

symptoms over time. What’s the difference? On the one hand you

say there isn’t one and there’s an HHS study.

Mr. SHARMA. I think what we said before in 1997, that since we

cannot conclude what may have caused their illnesses because of

the absence of precise and accurate information about how many

agents they were exposed to for how long, et cetera, a different way

of approaching this issue would be to understand the natural history of the disease by following these individuals over time and

monitor the progression of the disease.

At the same time, you take a look at what kind of symptomatic

treatment physicians are currently providing because they are

being treated by a number of physicians all over the country. Some

of those treatments may or may not be effective, and therefore you

take a look at what works, what doesn’t work, and then you share

this information with the rest of the physician community.

That type of research was not being done and after a considerable amount of time, VA has now reluctantly agreed to do this type

of work. The CDC report that we are referring to is a survey in

which they looked at two points in time but this is the kind of work

that should be systematically done.

Ms. SCHAKOWSKY. To followup on something that Mr. Sanders

was saying, it seems like there’s a lot of data and none of it fits

together and none of it leads anywhere and none of it seems to

make any sense in the end. You talk a good deal on the report

about coordination. What can we do to get better coordination?

You have, for example, lack of coordination which could result in

duplication as in the literature review contracts from the VA and

DOD. The VA responded in comments to your draft report that

these two projects used different methods, have different goals and

are not duplicative. Do you agree?

Mr. CHAN. No. I think that example is symptomatic of the problem in the approach being taken toward research.

You know, literature review is great if the literature includes relevant cases, but basically they are not really there. The problems

with pyridostigmine bromide have been known for a long time. I

said, so what? What do we do from here?

I think there’s a disconnect here basically between science and

policy. And I really hate to bring it up at this stage like that, but,

generally, the public wants answers to questions like who is sick,

how many are sick, are they being treated, are they being taken

care of, how well are they being treated, are they getting better,

are they worse, is there something that is helpful, that can be

shared with others? Those are the kind of questions people are asking.

The inside researchers are focused on testing specific hypotheses.

Is it this agent, is it that agent, is it chemical, is it PB, is it Leishmaniasis, is it oil well fires, and so on. They focus on very specific

agents and toxins that can affect the body. So the two types of

questions are disconnected in a sense. Then when you find out that

one agenct is an unlikely cause, the other one is also unlikely and

so on, it doesn’t satisfy the people who are left suffering.

I’m trying to look for an analogy. It’s almost like if someone tells

you we have reduced the sulfur level in the air by X percent, the

22

question that you want to ask is, can I breathe? We’re not answering that. That’s the disconnect I see.

So I agree that, in a way, we’re advancing through hypotheses

and find some interesting stuff. But in the end you find the people

who are suffering just want treatment and attention.

Ms. SCHAKOWSKY. Thank you.

Mr. SHAYS. Mr. Allen.

Mr. ALLEN. Thank you, Mr. Chairman.

Forgive me for groping on this issue a little bit, because, obviously, there are those of you who spent a good deal more time trying to understand this than I have, but I am struck by a couple

of your comments, Mr. Chan, and some other things that I have

been through. I am just going to talk for a moment and then I

would like your reaction to what I say. Because though I’m obviously in a field that is not my field, there are a couple of things

that strike me about how this research might be going based on

what you said and how it might be redirected.

It strikes me that to the extent—you just said that a lot of the

research focuses on specific toxins as if the analogy were to find the

particular virus that was causing a particular illness that basically

acts the same way on all human beings and that, it strikes me, is

a path of the research that may not be particularly productive because we may be dealing with something that is different.

And I’m going to mention now a woman in my district has just

put together this collection called Casualties of Progress: Personal

Histories from the Chemically Sensitive. Her name is Allison Johnson. And what she’s done—she’s published this at her own expense—is a series of stories. Six of them are stories of Gulf war

veterans, but they are stories about people who are afflicted with

multiple chemical sensitivity. And though I would not pretend to

have read this, I only got this 2 days ago, what I would say is this.

It strikes me that you have very individual reactions of the multiple chemically sensitive to a wide variety of different kinds of—

and I hesitate even to use the word toxins—chemicals of different

kinds. But what’s striking is the reaction. The symptoms may be

different for different individuals; and, in fact, the causation, the

chemicals, the agents that are causing a human being to react this

way are different for different people. So to the extent we do research pursuing is it PB, is it the oil, whatever, that research is

not as likely to lead anywhere productive.

What I am struck with from just glancing this moment at your

report is appendix III and the failure and the effort to reach a

working definition and, in particular, Mr. Haley’s definition saying

the three primary syndromes are impaired cognition, confusionataxia, this is page 31 of the report, and arthro-myo-neuropathy.

I guess that’s how you pronounce it. Isn’t it the case that if we’re

going to get a grip on this problem that there needs to be sort of

some consensus about how to go at it, what kind of problem we’re

dealing with?

To me, that’s not so much a problem of research. It’s a problem

of conceptualizing what it is we’re talking about.

And so what I guess what I’m asking is, is any of the research

directed, first of all, specifically to the multiply chemically sensitive

23

to this sort of area and, second, is there in your opinion a focus of

the research that is off track or needs to be changed or whatever?

That’s a long, rambling statement, but I trust you can do something with it.

Mr. CHAN. Let me try.

I think the approach that’s been taken over the past 9 years is

the classic scientific approach one would take. That is, you look for

possible agents and then determine potentially what’s the exposure

level, are there responses to it, are there potential causes and effects. If there is something, then what the diagnosis should be and

then the treatment and measure outcome. That can be done if it’s

merely a single exposure, particularly if we’re talking about a virus

or other things of that kind.

I think that worked well in the past as a model that I’ve seen,

and certainly there are lots of success stories from that. But I

think—I tend to agree with you that this model may not work here,

that a different model may be needed—not so much because scientists cannot arrive at conclusions but rather because you’re talking about multifactorial effects.

The approach basically they have done is to take out the possible

potential causes individually rather than accepting multifunctional

causation as a possibility. That is, if you have one agent and find

it can cause a 1 percent change and that’s not significant, then you

withdraw that and try another one. But putting them together may

identify synergisms that occur. So I don’t think the model used

starts out looking at it that way.

Back in 1997, we felt that reliance on the traditional model of

those responses and exposures which we didn’t know much about

for this particular war, then why not begin to diagnose the problem

of the illness and then look for treatment that may turn out to be

successful or even failure, to learn from that. That’s how we ended

up with our recommendations.

So I agree that you have to look at it differently.

Mr. SHAYS. Mr. Blagojevich.

Mr. BLAGOJEVICH. Thank you, Mr. Chairman.

First of all, Mr. Chan, let me just reiterate what Congressman

Schakowsky said about 700,000 Gulf war veterans across the country. Of them, over 100,000 nationwide—in our State of Illinois,

3,500 of them are sick due to possible toxic exposure during the

Gulf war, yet we have no diagnosis or a cure. My question to you,

sir, is are we getting any closer to understanding the causes of the

Gulf war illness? That’s my first question.

Mr. SHARMA. I think there are several testable hypotheses that

have been proposed in the published research that was done outside the Federal Government funded research.

One way to approach this issue is to test those hypotheses and

see if indeed these individuals could get better.

The second approach is that if you’re not going to do a

hypotheses testing research, then you monitor these individuals

over time because these individuals are experiencing symptoms

which we may not be able to explain why, such as headaches or

arthritis, but there are certainly some symptomatic treatments

available. If those symptomatic treatments are effective and working and different people have different approaches for treating the

24

same thing, then that kind of information should be systematically

collected, evaluated and then disseminated to others. This is currently not being done. Specifically, there are several testable

hypotheses. They are not being proactively and vigorously pursued.

Mr. BLAGOJEVICH. You’ve mentioned that researchers face persistent problems in ascertaining veterans’ specific exposures. What

do you mean when you say that?

Mr. CHAN. Well, most of the data that’s gathered through the

registries and the studies, through telephone interviews, are based

on recall. They ask questions not only on where you were. It’s very

difficult for a soldier to say I think I have been exposed to, let’s

say, chemical agents without knowing it’s ever been used. That’s

the difficulty about it and that’s what I meant by the need to know

what you’ve been exposed to.

And even tracking who got what type of vaccine was difficult because the records weren’t clear as well as how many PB pills that

you would take and could you be affected by radiation because

when we start bombing Iraq the radiation could leak out and so on.

The soldiers have no idea about what they were exposed to. All

they know is they’re feeling bad, and these are the kinds of symptoms that they have. So it’s hard to reconstruct. And I think the

example one would go back to is how difficult it was for us to track

the use of dioxins such as Agent Orange back in Vietnam.

Mr. BLAGOJEVICH. Thank you.

Mr. SHAYS. Mr. Chan, we want our troops properly diagnosed.

We want them effectively treated, and we want them fairly compensated. That’s the bottom line. Do we know who is sick? Answering this way doesn’t allow the recorder to respond. Do we know

who is sick?

Mr. CHAN. We know some people who are sick. We don’t know

how many are sick and whether they are coming through the system or going to private physicians.

Mr. SHAYS. Do we know how sick they are?

Mr. CHAN. No.

Mr. SHAYS. Do we know if they are getting any better or any

worse?

Mr. CHAN. We don’t know.

Mr. SHAYS. Has there been any progress in GAO’s 1997 recommendations to the research board?

Mr. CHAN. Well, there were a few more studies done, but generally I would say that concerning the progress to the end goal or

treatment, no, there hasn’t been any progress toward that.

Mr. SHAYS. To what extent does the Federal research effort on

Gulf war illnesses include the development of a system to track, diagnose, and treatment outcomes of veterans?

Mr. SHARMA. I don’t think there has been any systematic approach to following up these individuals over time. These agencies

have not shared with us any such plan.

Mr. SHAYS. To what extent have the 21 major research questions

set by the Research Working Group in 1995 been answered?

Ms. ZUKERMAN. The Research Working Group hasn’t published

an assessment of the extent to which those questions have been answered. They told us last year that some of them had been answered more completely than others.

25

Mr. SHAYS. So there have been—there’s been none, correct?

Ms. ZUKERMAN. No assessment, that’s right.

Mr. SHAYS. In what ways was OSAGWI’s support contracts improperly awarded?

Mr. CHAN. I can answer in general. I think we looked at the contract and we found a problem with three of the contracts that were

made. The problem with one was the statement of work was too

broad. The second was that it was outside of the scope of the contract for what the contractor was doing. And, finally, OSAGWI

made known up front that they have a preferred vendor so, as a

result, they are the only one who actually compete for it. But the

general principle we go by is that these contracts should be there

to enhance competition, and by these actions we find that it did not

enhance competition.

Mr. SHAYS. The President established a Research Working Group

which was to get the DOD and the VA and HHS to work together.

What are the consequences of OSAGWI’s decision to avoid coordination of its activities with the Research Working Group?

Mr. CHAN. Well, the consequences that you end up having duplication. We have two examples of that, particularly with depleted

uranium and PB.

Ms. ZUKERMAN. The review of literature.

Mr. CHAN. Right, the review of literature and so on. I think those

were the examples. And I think the issue is really not so much of

the costs involved but rather the lost opportunity to address other

more important issues that need to be addressed.

Mr. SHAYS. In your four findings—obviously, we spent $121 million in 2 years. You said that the Persian Gulf War Coordinating

Board’s research group has not published any assessment to the extent of to which its specific research objectives has been satisfied.

That’s just a devastating finding. You said research is ongoing, and

then you said OSAGWI has received 19 of the 20 reports due from

its contractors. It has published only six. Of these reports, 14 remained in draft or review status for a year or longer. That to me

is unbelievable. I’d like to know what the heck is going on as it relates to that point.

Mr. CHAN. Well, when we initiated our study at your request one

of the purposes was to examine the contracts—particularly the

ones with RAND—and at that time OSAGWI had six of the draft

reports to review. And the review, that they’re talking about, occurred when the contractor had delivered the product to DOD and

then it was reviewed internally.

Mr. SHAYS. But it sounds like, one, you don’t like the results or

you’re trying to change the results. But the bottom line is you paid

for a study. Show us the study.

Mr. Metcalf, you have the floor.

Mr. METCALF. Thank you, Mr. Chairman.

Yes, Mr. Chan, I would like to ask you and your colleagues to

comment on this new peer review study, if you will. Since it has

now met the criteria that the Department of Defense had set forth,

that is, peer review publication, and the antibodies to squalene and

Gulf War Syndrome appears to me to meet that request, how

should we best use what we now know to date?

26

Mr. CHAN. Well, at your request, we did a study and published

it back in March of last year; and at that time I think we did not

really evaluate the science of developing an assay to the squalene.

We did find it’s plausible that it could be done but certainly we did

not examine the possible cause and effect in terms of the health of

the veterans. But, nevertheless, I think the title of our report stated that questions about presence of squalene antibody in veterans,

can be resolved.

I want to emphasize the words ‘‘can be resolved’’. At the time,

the Department of Defense, particularly in the Office of Health Affairs, said we never gave them the squalene, and it’s not our problem, and if indeed it’s a case, it’s important for the research to publish their results through a peer-reviewed journal.

At that time we also said that we disagreed with DOD in regard

to that issue, because we felt that DOD should take the opportunity to begin addressing the potential and possibly resolving the

question of whether or not the squalene antibody could be contributing to the illness of Gulf war veterans. And what we suggested

was a very small step. The small step is, well, if it takes too much

effort internally to develop such an assay and develop it, why don’t

we just go and ask the researchers at Tulane and try it out if in

fact the researcher is willing to share their own assay. And DOD

did not do that. And so, as a result, I think finally this article has

been published; and I hope DOD would consider this thing seriously.

Mr. METCALF. Has there been a serious examination of the role

that vaccinations may have played in Gulf war illnesses and should

there be a serious examination in your view by the DOD?

Mr. CHAN. I think the answer is yes, but I would like to raise

it in light of—unfortunately, I’m trying to recall.

I think it’s important to understand—not just to focus on the Anthrax vaccine per se but also that the soldiers received over a

dozen and a half different vaccines during that period because they

are being deployed into areas where it’s unclear how well they are

prepared to meet the environmental conditions. So not only did

they have the normal type of vaccines but also vaccines against biological agents and even countermeasures against chemical agents

such as PB pills and so on. So there are a lot of things that the

soldiers received. There’s no study as to whether the combination

of these things the soldiers received could have any effect on them

in general.

Mr. METCALF. Thank you.

Mr. SHAYS. We will go back to other committee members and see

if they have a followup question, but I want to just ask you how

many peer review studies has Federal research spending produced

in the last 2 years?

Ms. ZUKERMAN. We looked at those projects that had been completed by the end of 1998 to see what portion of the completed

projects had resulted in one or more peer reviewed reports, and we

found that about two-thirds of them had. I think Dr. Feussner can

probably provide current information on the total number of publications.

Mr. SHAYS. Thank you.

Mr. Sanders.

27

Mr. SANDERS. Thank you, Mr. Chairman.

Let me get back to a point that I tried to raise before. During

World War II, the U.S. Government wanted to build an atomic

bomb, and they developed—that was the end goal. For better or

worse, they wanted an atomic bomb.

The President then put together a project called the Manhattan

Project. They assembled the best minds in the country. They went

forward in a relatively short time. They got their goal. My thought

had been from the very beginning that, to solve the problem of Gulf

war illness, that is something that we had to do as well. What I

am stunned and distressed about is the absolute lack of direction.

Now, the military knows something about winning wars. It

doesn’t matter if you win a battle over here or if you do something

over there. The goal is to win the war.

Our goal is to understand the cause of Gulf war illness and to

develop an effective treatment. That’s clearly what we want to do.

We don’t want to scatter over a million different directions. We

need a general, somebody who is ultimately saying this is good research. We’re gaining on it. This is useless, forget it. Let’s keep

going. We’re putting our money in here.

Clearly, it seems to me that has not been the case, at least from

the U.S. Government. That’s the bad news.

The good news, it seems to me, is that, as I think Dr. Sharma

indicated, outside of Federal funded research, there appears to

have been some breakthroughs. None of us to the best of my knowledge here are scientists. That’s our problem. We have to rely on

you and others to tell us the truth and the validity of some of the

studies that we’re seeing.

This is my question. Mr. Metcalf raised this a moment ago. Just

the other day at Tulane a study comes out that says that it is, in

layman’s terms, if somebody has squalene antibodies in them, it is

likely that they are suffering from Gulf war illness. If they do not,

it is likely they are not suffering. From a layman’s point of view,

this seems to be a breakthrough done outside, I guess, of federally

funded research. Simple question. After 9 years, has the U.S. Government itself, the VA, the DOD, been doing research on this

issue?

Mr. CHAN. Not in terms of the effect of squalene on individuals,

but they have done research using squalene in other vaccines.

Mr. SANDERS. Let me again, as a layman, if it turns out that he

has squalene antibodies, he does not have squalene antibodies, he

has Gulf war illness, he does not. Am I wrong in suggesting that

is a significant breakthrough, that we have learned something?

Mr. CHAN. Potentially, yes.

Mr. SANDERS. Potentially, yes. It stuns me that we need Tulane

to come up with this, and where was the VA?

Dr. James Fleckensteen from the Texas Southwestern Medical

Center says, according to the AP, brain scans of soldiers who believe they suffer from Gulf war illness indicate evidence of brain

damage. Now, again, I don’t know whether it’s true or not. That’s

what Dr. Fleckensteen says.

If I go to the VA or the DOD, what are they going to tell me

about those studies? Have they tested that hypothesis? Has the VA

or the DOD said, yeah, we’ve done a brain scan. There’s brain damVerDate 11-MAY-2000 08:58 Dec 27, 2000 Jkt 000000 PO 00000 Frm 00031 Fmt 6633 Sfmt 6633 C:\DOCS\67151.TXT HGOVREF1 PsN: HGOVREF1
28

age. He was in the Gulf war. We have learned something. He may

have a treatment.

What has the U.S. Government done with that? Anything?

No, OK. Multiple chemical sensitivity, Tom Allen talked to that,

and I talked to that particular woman on the phone. I have talked

to hundreds of veterans in the State of Vermont who are suffering

from Gulf war illness. Some of them tell me when they are around

perfume, they get sick. If they walk through a grocery store and

detergent smell comes up, they become sick. What studies have

been done to say are these guys crazy or have they been exposed

to chemicals and do more chemicals impact them?

If I am suffering from multiple chemical sensitivity, the last

thing that I want is to be eating certain foods that make me ill.

What does the U.S. Government have to say about the truth about

that hypothesis? Does the Government say we are going to pursue

that? Are there any studies to help me with whether these people

are crazy or not?

No.

You remember years ago we heard shocking testimony about the

potential of pyridostigmine bromide. I gather a number of months

ago the VA said yeah, we cannot rule that out.

I mean, we cannot rule that out.

What studies have been done to tell us if in fact pyridostigmine is part of the problem? Have they told us after $120 million that

we cannot rule it out?

Dr. Robert Haley said that a genetic trait can predispose people

to Gulf War Syndrome. People can have the same exposure, but

with a genetic trait, you are more likely to get sick. Is Haley right

or wrong?

In other words, there is some important research taking place

out there. We are not scientists. We can’t judge the validity of that.

Some people are making important statements which if they are

correct sounds to me like we are going in the right direction. Who

in the Government is making the judgment no, this is wrong, we

have tested that. That is nonsense, this is right. Who is the general

in charge of telling us what direction we should go?

There is some good news, Garth Nicolson out in California had

a hypothesis that mycoplasma infection might be a cause. The VA

is testing that hypothesis. The VA is doing the right thing.

But where else is the VA doing the right thing to validate or not

these and other hypotheses. That is my question?

Mr. CHAN. Well, I think what you’ve said describes the basic

frustration that we hear from the veterans about the process. They

don’t feel that the agencies are hearing them, representing them,

responding to them to address those issues in a vigorous way. They

raise all kinds of questions and those are pretty well known questions that you brought up. It requires an extraordinary effort to

have the agency to initiate something that is coming from the outside.

So I think there is a natural distrust of the agency as a result.

Therefore, even when vigorous research done by the Federal Government comes out as saying that there are really no problems out

there with this particular exposure, it is difficult to make it believable because I don’t think if you look at the structure that is made,

29

the veterans are not represented in terms of the voices within the

VA, DOD and HHS.

So that is what I meant that there is a real disconnect here in

terms of science and policy. I am not questioning the science and

the research done, let me make sure that you understand that. But

at the same time, veterans are saying, ‘‘That is not what is happening to me and who is listening to me?’’ First they say, you know,

the diseases you mentioned are not in ICD–9 code; and, therefore,

we don’t consider those. Then we go to the next thing.

Yet then you come out and say even though there is a higher

prevalence of this kind of disease, it is not unique. So then you

begin to say, what do I have to do to prove to you—and I am speaking from the veterans’ point of view—that I am sick?

You see what I am saying? We keep on raising the bar to a different level.

Mr. SANDERS. Let me jump in and conclude my remarks. Mr.

Chairman, what I have concluded and what Mr. Chan has said,

what we are dealing with is a new type of illness. If someone was

wounded in battle with shrapnel or gunshot wounds, I suspect the

VA and the DOD is best to treat those problems. But we are dealing with something which is new and different. There is not familiarity or an openness to understanding that new type of illness

which may have been caused by environmental degradation and

toxicity and so forth and so on.

It seems to me, Mr. Chairman, that we have got to conclude that

while there is some important research going on around this country, the Federal Government is not taking advantage, it is not trying to grapple with that research and give us a direction where to

go, and I think we have got to conclude that ultimately we should

be taking the responsibility for going forward out of the Federal

Government and giving it to those people who believe that there

is an illness and who know how to manage the research so we finally will understand the cause of this problem and develop a

treatment. I think you will agree, Mr. Chairman, 5 years from now

we don’t want to go through a similar hearing.

Mr. SHAYS. Thank you. Ms. Schakowsky.

Ms. SCHAKOWSKY. I have to say I was stunned once again when

the chairman asked a series of obvious and very simple questions,

the response to which was we don’t know.

When I look at the research objectives identified by the Research

Working Group of the Persian Gulf Coordinating Board, the 21

questions that were asked, 11 of those questions would indicate to

me that you have to go to the veterans themselves.

The first question, what is the prevalence of symptoms, illnesses

in the Persian Gulf veteran population? Questions like do Persian

Gulf veterans have a greater prevalence of altered immune functions? There are 11 questions that deal specifically with the veterans themselves.

Then I look at the reports received and released, the research

which has been done, the many studies which have been done, and

what I, in looking through these, and again I am not a scientist,

what I see is two which would address themselves specifically to

the veterans. One that says birth defects among children of Gulf

war veterans and potential nerve agent exposure, a report which

30

was completed in draft of 1998 and has not been released, and a

comprehensive clinical evaluation, reports on findings from a telephone survey of Persian Gulf war veterans, a draft submitted in

1997 and not released, so when you talk about a disconnect, it

seems like all of the money, and it is clearly considerable, $121 million, not all on research, but why is it that the studies which have

been done seem not to connect with the research questions that

have been asked? And why do so few of them actually focus on the

veterans?

Mr. SHARMA. I think you have really hit on a very important

issue. Questions have been raised about the credibility of the Federal research in this arena. When we went out and talked to the

veterans, there was an overwhelming perception that the Federal

Government is only interested in demonstrating that their illness

is not unique or it is psychological. And if much of the findings of

the federally funded research shows there is no difference. No difference does not imply that they are no illness. We still need to

provide them some treatment, and we also must pay attention to

what may have caused their illnesses.

Our in depth examination of that research showed that because

there are some significant methodological problems with that research that would question the conclusions that have been reached.

One in particular that I will discuss with you is the birth defect

studies. In that study they looked at—— Ms. SCHAKOWSKY. I’m sorry, which study?

Mr. SHARMA. The birth defects.

Ms. SCHAKOWSKY. Thank you.

Mr. SHARMA. First of all, they only looked at the military hospitals in that study, and we know that if you are going to have a

complicated pregnancy, that you are more likely to be referred out.

Second, they only looked at those who were on active duty so it

wasn’t a very comprehensive, well-designed study which would

allow you to conclude definitively on this issue, but the way that

the study was presented, case closed. That brings some question

into the minds of some of the veterans who are experiencing these

illnesses.

Ms. SCHAKOWSKY. Why was that study not released? It says here

no.

Ms. WARD-ZUKERMAN. The report that was done for us, we

looked at the rates of release among products due from OSAGWI’s

research contracts just to see how productive their expenditures in

that direction had been. We didn’t draw any conclusions about why

they were not released.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

Mr. SHAYS. Thank you, Ms. Schakowsky. Mr. Blagojevich.

Mr. BLAGOJEVICH. First of all, Congressman Sanders, the last

time anyone suggested I had brain damage was the last election.

Let me followup on what Congressman Sanders and Congresswoman Schakowsky asked the panel. What exactly is the Research

Working Group charged with coordinating?

Ms. WARD-ZUKERMAN. They are charged with coordinating research in general. There is nothing in the law to prevent them from

coordinating other things. They are just to organize the Federal research effort.

31

Mr. BLAGOJEVICH. And that includes only medical research or

other things as well? What would you say that their jurisdiction is,

or where is it established?

Ms. WARD-ZUKERMAN. There is no reason that they could not coordinate with, for example, the Office of the Special Assistant and

its work on exposures.

Mr. BLAGOJEVICH. Let me be more specific. Which agencies are

currently operating projects that are coordinated through the Research Working Group?

Ms. WARD-ZUKERMAN. The Department of Defense, Health and

Human Services, Veterans Affairs. At one point they had a representative from the Environmental Protection Agency.

Mr. BLAGOJEVICH. Is there anything that you can tell us about

what we might need to go forward to make serious progress in

these research efforts, something positive to suggest here about the

future on this?

Mr. SHARMA. As Mr. Chan mentioned earlier, we need to be

proactive. We have several testable hypotheses out there. They

have been published in peer reviewed journals, and we must have

an open mind and aggressively pursue those hypotheses.

When we look at the portfolio of the existing research, we still

see that those researchers from the private sector that have come

out with some testable hypotheses are still not being funded by the

Federal Government. A couple of them initially did get funded

through OSAGWI’s efforts, but later on the funds were withdrawn

so they still are not receiving any Federal support. It is very difficult to explain why or why not. When they come, you can ask

them and they will be able to address this issue better.

Mr. CHAN. Let me answer the question a different way.

I believe what I said earlier about the mismatch between public

policy and the science side, particularly in the questions that Mr.

Allen had asked. When I mention things such as disconnect, to me

it needs to be a totally different way to look at science and how to

approach it.

To me it seems like science has a tendency to look at research

as an end goal rather than treating people as an end goal, and I

am not denigrating science in any sense, but each time you find

some findings such as what was done in the RAND study, what is

the bottom line. The bottom line is we need to do more research.

So you find from the general public’s point of view there is a

great finding, we got something after a long time of reviews and

so on, but let’s look some more. Let us be sure. I think we can

never reach that stage where we are so certain about cause and effect even on a single agent.

So to keep on pursuing it to the nth degree I think it is fine from

the science point of view in terms of research, but from the health

side, I don’t think that model is the best way. I am not taking a

position and discussing this in terms of what one would question

in terms of where does one go from here, but I think the kind of

research that Mr. Sanders talked about are people with expertise

out there who say hey, based on the description of these patients,

I have similar kinds of experience with them. Let me try that out.

It is more from that direction than to say I need to know exactly

what they are exposed to and what the dose is and what kind of

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response are they having. Are they common to a single person, is

it only applied to women versus men and all of that stuff. They just

say hey, this looks like something that I am aware of, and they

talk a long time before the agency would accept putting money in,

and it is usually through congressional pressure.

So in that sense I am talking about the process itself. It needs

to be examined from that light because otherwise we can never

solve the problem. Maybe we will never know what caused these

illnesses, but at the very least, we try our very best to take care

of the soldiers, and they are indeed sick; and meanwhile science

can march on on its own.

Mr. SANDERS. Mr. Chan, isn’t really what you are saying is that

in one sense we are looking at theory, and in the other sense we

have a soldier who is sick and after 9 years of research, what is

the treatment? Is that what you are really saying?

Mr. CHAN. Yes.

Mr. SHAYS. Mr. Allen.

Mr. ALLEN. Mr. Chan, thank you. I think what you were saying

just now is the heart of the matter. It comes back to what I was

saying earlier about there needs to be a conceptual shift here in

terms of the objectives. While the conversation has been going on,

I looked back at the research objectives identified by the Research

Working Group, and it is interesting. You add up the number of

questions that are about specific exposures, and then you add up

the number of questions about specific symptoms in this group as

opposed to the control group, and you have pretty much exhausted

the entire list.

If our focus were on the veterans, and you just said that certainty in determining cause and effect, you said in so many words,

is not achievable perhaps in this area. Or at least if it is achievable

in some measure, it will take us some period of time to get there.

And the focus really should be dealing with the veterans’ problems

as they exist and figuring out how to help them. There needs to

be I would say a new focus to the research.

I have to say while I am here looking through this report, I was

struck by appendix 6, the comments from the Centers for Disease

Control and Prevention because they refer to two studies, one a

health assessment of Gulf war veterans from Iowa and a CDC-Air

Force study, and I want to mention that CDC-Air Force study. On

page 54 they defined a case as having one or more chronic symptoms from at least two of three categories, fatigue, mood cognition

and musculoskeletal. So they are not requiring that each case be

exactly the same, but are saying two of these three categories you

would have to have a symptom. And it is categorized as mild to

moderate or severe. The prevalence of mild to moderate and severe

cases were 39 percent and 6 percent respectively among 1,155 Gulf

war veterans. Versus 14 percent compared to 39 percent and 0.7

percent compared to 6 percent among 29 nondeployed veterans.

The interesting thing about this is that they found no association

between the chronic multi-symptom illness and a variety of factors

involving service in the Gulf war. They also found these symptoms

were prevalent in 15 percent of the control group. Think about

that.

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That means that the Gulf War Syndrome is a subset of a larger

problem. And so to the extent we are focused on specific chemicals

in the Gulf war, we are going to miss the point in part, that if it

is something like multiple chemical sensitivity, it is prevalent in

the rest of the population, too, and we would advance our research

about Gulf war if we looked at the rest of the population that has

these symptoms and if we refocused the research on trying to deal

with the symptoms and with the veterans and not the particular

chemical that may or may not have been present in the Gulf war.

I guess there is not a question buried in there, but is that a direction that we ought to move in?

Mr. CHAN. I think, you know, I would agree with you that we

should look at it in a different way and see if we can really resolve

some of these issues. I agree with you, yes.

Mr. SANDERS. Tom, if I can interject, and I agree with everything

that you have said, after years of discussion about multiple chemical sensitivity, to the best of my knowledge the U.S. Government

does not own one what we call environmental chamber by which

you can begin to treat and better understand multiple chemical

sensitivity. A few million dollars, and we still don’t own that.

Mr. SHAYS. I would share with you the observation that Henry

Kissinger made of Jimmy Carter’s foreign policy and say that I

think it applies to the Research Working Group. He said when you

don’t know where you are going, any road will get you there.

We will go to our next panel. It is comprised of five people: Dr.

John Feussner, Chief Research & Development Officer, Department of Veterans Affairs; Dr. John Mazzuchi, Deputy Assistant

Secretary for Health Affairs, Department of Defense; Dr. Robert

Foster, Director of BioSystems, Department of Defense; General

Dale Vesser, U.S. Army (Ret.), Deputy to Special Assistant for Gulf

War Illnesses, Department of Defense; and Dr. Drue Barrett, Chief

Veterans Health Activity Working Group, Centers for Disease Control & Prevention, DHHS. I invite all our witnesses to stand, and

I will swear them in.

[Witnesses sworn.]

Mr. SHAYS. I note for the record that all five witnesses have responded in the affirmative.

We will do it in the order that I called you. Let me just say that

any comments that you want to make about observations about the

first panel are welcome. This is your opportunity to make your

points.

Dr. Feussner.

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STATEMENTS OF JOHN FEUSSNER, M.D., CHIEF RESEARCH &

DEVELOPMENT OFFICER, DEPARTMENT OF VETERANS AFFAIRS; JOHN MAZZUCHI, PH.D., DEPUTY ASSISTANT SECRETARY FOR HEALTH AFFAIRS, DEPARTMENT OF DEFENSE;

ROBERT FOSTER, PH.D., DIRECTOR, BIOSYSTEMS, DEPARTMENT OF DEFENSE; LT. GEN. DALE VESSER, USA (RET.), DEPUTY TO THE SPECIAL ASSISTANT FOR GULF WAR ILLNESSES, DEPARTMENT OF DEFENSE; AND DRUE BARRETT,

PH.D., CHIEF, VETERANS’ HEALTH ACTIVITY WORKING

GROUP, CENTERS FOR DISEASE CONTROL & PREVENTION

Dr. FEUSSNER. Thank you, sir. Mr. Chairman and members of

the subcommittee, thank you for the opportunity to discuss research in Gulf war veterans’ illnesses today. I do request that my

formal statement be entered into the record as if read.

Mr. Chairman, at the outset let me say that as a physician and

scientist with over 25 years experience I believe that the research

challenge posed by Gulf war illnesses represents one of the greatest

recently faced by the medical research community. These veterans’ illnesses, their fears about their current and future health, their

frustrations with a paucity of hard answers and ready treatments

motivate all of us to persist in our efforts to understand the nature

of their illnesses, to explore new treatment strategies, and to be responsive when new concerns or potential illnesses arise. In my

opinion these veterans earned and in fact deserve every consideration and every effort that we can muster on their behalf.

Mr. Chairman, by year’s end the Federal Government will have

expended approximately $159 million for health research in the

Gulf war. Right now there are over 150 projects in a research portfolio. To date 47 projects have been completed, resulting in 98 peer

reviewed publications in the scientific literature. There are currently 116 principal investigators from DOD, VA, HHS, universities and other nongovernment organizations engaged in this effort.

Because of the obvious importance of our ensuring appropriate

effective treatment of Gulf war veterans’ illnesses, my office invited

proposals for multi-center trials for candidate treatments of medical syndromes or illnesses among Gulf war veterans. The VA Cooperative Studies Program is conducting two treatment trials known

as the ABT, for antibiotic treatment, and EBT, for exercise and behavioral treatment. Patient characteristics for entry into both of

these trials are similar. All Gulf war veterans who served in the

Gulf between August 1990 and 1991 may participate. Patients are

considered eligible for enrollment into the trial if they have at least

two of three symptoms: Fatiguing illness, musculoskeletal pain and

neurocognitive dysfunction.

The ABT trial, the antibiotic trial, seeks to study 450 Gulf war

veterans at 28 sites throughout the United States. The hypothesis

of this study is antibiotic treatment directed against mycoplasma

species would improve functional status of patients with Gulf war

veterans illness who are tested as mycoplasma positive at baseline.

Early demographic information from the study shows that 15 percent of the participants are women, nearly 20 percent are minority

groups, and about 70 percent are currently employed. Nearly 85

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percent currently enrolled in this study have all three symptoms

that I mentioned earlier.

The EBT trial seeks to study about 1,350 Gulf war veterans at

20 sites throughout the United States. The primary hypothesis is

that aerobic exercise and cognitive behavioral therapy will significantly improve physical function in veterans with Gulf war illnesses and that the combination of CBT and exercise will be more

beneficial than either treatment alone. So far nearly 500 veterans

have joined this study.

Mr. Chairman, I now want to update you on a national survey

of Gulf war veterans authorized by public law. The survey has been

conducted in three phases. My office awarded funds for Phase III

of the National Health Survey in November 1998. Currently 16

sites are participating in this nationwide study, which involves special examinations, including neurologic, rheumatologic, psychologic

and pulmonary or lung evaluations. To date over 1,000 veterans

have participated in this study and 1,230 spouses and children of

these veterans have been examined.

Our broad research partnership has yielded important new information about our veterans and their health problems. Mr. Chairman, I would like to share some of these with you today.

The Iowa study of Gulf war veterans indicates that nearly 90

percent of veterans rated their health status as good to excellent

while the remainder rated their health status as fair to poor. Of

Gulf war veterans, 14 percent said they experienced a significant

decline in their health status. Based on VA and DOD mortality

studies it appears that there are not more deaths from disease-related causes among Gulf war veterans, but we continue with this

study.

From a DOD study, infants of Gulf war veterans have not experienced a greater prevalence of birth defects but studies here also

continue.

The Baltimore VA is following 33 United States soldiers wounded

by DU during the Gulf war. The team recently demonstrated elevated urine uranium excretion by these soldiers who have retained

DU shrapnel. Importantly, there is no evidence of a relationship

yet between the uranium excretion and kidney function. While we

have no evidence of adverse outcomes from the uranium exposure,

these veterans remain under close surveillance.

One chemical study in mice indicated, for example, that swimming stress increased penetration of pyridostigmine bromide across

the blood-brain barrier. We had discussed that study in our February 1998 hearing. However, other studies in Guinea pigs exposed

to extreme heat stress suggested that PB does not cross the bloodbrain barrier. Yet another research project recently reported that

the effects of low-dose PB on the neuromuscular junction were fully

reversible following cessation of PB treatment.

The Research Working Group will continue its research on the

toxicology of such chemicals. Veterans of the Gulf war have voiced

concerns about possible association between ALS, amyotrophic lateral sclerosis, and service in the war. Although there is no indication of an excess rate of ALS, available data may underestimate

the true rate. The VA is leading an effort to identify all cases of

ALS among Gulf war veterans. This case finding effort will take

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about 1 year and will provide definitive information about the rate

of ALS among Gulf war veterans.

Mr. Chairman, thank you for giving me the opportunity to appear before your subcommittee. My written testimony covers in

more detail these and other matters of concern to the subcommittee. I conclude my remarks now and will await your questions.

[The prepared statement of Dr. Feussner follows:]

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Mr. SHAYS. Thank you. Mr. Mazzuchi.

Dr. MAZZUCHI. Thank you, Mr. Chairman, and members of the

subcommittee, I am pleased to be here today to provide testimony

on our current clinical and research efforts to understand and treat

illnesses among Gulf war veterans. I too would ask that my formal

statement be entered for the record. This is a summation of it in

the interest of time.

The Office of the Assistant Secretary of Defense for Health Affairs has a primary interface in the Department’s biomedical research program and that derives primarily from our role as cochair along with the Director of the Department of Defense Research and Engineering of the Armed Services Biomedical Research

Evaluation and Management Committee, which facilitates consideration of DOD biomedical research. The Assistant Secretary of Defense for Health Affairs also serves as the primary alternate member and primary DOD liaison official with the Military and Veterans Health Coordinating Board and is a voting member of the

board’s research working group which Dr. Feussner chairs.

Through many years of research and progress in military medicine, tremendous strides have been made in medical protection and

care provided to our soldiers, sailors, airmen and marines. The

medical consequences of the Gulf war made it clear, however, that

threats remain—some threats remain poorly understood and inadequately addressed. Despite few combat casualties and low rates of

disease in nonbattle injuries in both the buildup to the war and the

war itself, many veterans have since reported health problems, including medically unexplained symptoms which followed their service in the Gulf war. These unexplained illnesses have proven to be

both frustrating to diagnose and frustrating to treat. Efforts within

the Department of Defense to care for Gulf war veterans have reinforced our appreciation of the seriousness of their health problems,

and military physicians fully recognize that these veterans require

compassionate evaluation and care.

The lack of predeployment health and deployment exposure data

is recognized as a chief limitation in the evaluation of Gulf war veterans illnesses. Numerous improvements are being made to gain

and analyze such data regarding future U.S. military deployments.

These efforts include capturing better service entry health data,

pre and post-deployment health data, environmental and morbidity

data during deployment, improved communication with troops regarding deployment health risks, and focused clinical evaluation

and epidemiologic research programs of our deployed populations.

In the 1998 report to Congress, Effectiveness of Medical Research

Initiatives Regarding Gulf War Illnesses, the Department of Defense identified the need for a coordinated capability to apply epidemiologic research to determine whether deployment related exposures are associated with post-deployment health problems. Subsequent to this report, Congress authorized the Secretary of Defense

to establish a center devoted to ‘‘longitudinal study to evaluate

data on the health conditions of members of the armed forces upon

their return from deployment.’’

On September 30, 1999 Dr. Sue Bailey, the Assistant Secretary

of Defense for Health Affairs, directed the establishment of DOD

Centers for Deployment Health, creating a research center at the

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Naval Health Research Center, San Diego, CA with the mission of

longitudinal study to evaluate data on the health conditions of

members of the armed forces upon their return from deployment.

A clinical center was also established at the Walter Reed Army

Medical Center to oversee the Department’s clinical evaluation program for deployed service personnel.

One of the many lessons learned of the Gulf war is that the lack

of ongoing population based longitudinal health studies has limited

our capability to identify deployment-related health outcomes. Additionally, the only way to determine health status change is

through a prospective monitoring of health. Recognizing the challenges of conducting such studies, DOD and VA asked the National

Academy of Sciences Institute of Medicine to suggest appropriate

scientific and practical methodologies to do this. In response the Institute of Medicine recommended in its report, Gulf War Veterans

Measuring Health, that DOD and VA institute longitudinal cohort

studies of both Gulf war and other deployed veterans. DOD and VA

have initiated planning to develop a research program of ongoing

longitudinal studies with a specific aim of determining how the

health of U.S. military veterans changes over time. This study, entitled the Millennium Cohort Study, will focus on U.S. military cohorts of the future yet be constructed so as to enable comparison

to military cohorts of the recent past. A concurrent program will

use similar data collection methods to study a comparable Gulf war

veteran population. The goal for these two comprehensive studies

is to determine how the health of several veterans’ cohorts changes

over time. The specific goal of the Millennium Cohort Study is to

identify and prospectively follow health outcomes of future U.S.

military cohorts beginning in the year 2001. In this study we intend to guide the development of DOD medical information programs so that future investigators will not have to rely so much on

special investigative studies to determine the effects on health of

military deployments.

We appreciate the interest this committee has shown in the

health of our men and women who have served their Nation in the

armed forces. The military health system wants to achieve its goal

to care for those men and women and their families and to protect

their health. We also recognize that our commitment to veterans’

health cannot end when they leave active service. We will maintain

a strong post-deployment evaluation and care program in coordination with the VA and move forward to strengthen our force health

protection program.

Again we appreciated the opportunity to testify before the subcommittee, and look forward to receiving your questions. Thank

you, Mr. Chairman.

[The prepared statement of Mr. Mazzuchi follows:]

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Mr. SHAYS. Thank you, Dr. Mazzuchi. Dr. Foster.

Dr. FOSTER. Thank you, Mr. Chairman, and members of the subcommittee. Thank you for the opportunity to briefly discuss the Department’s science and technology program addressing Gulf war

veterans’ illnesses and general deployment health concerns. I too

request that my formal testimony be entered for the record, and I

will be abstracting some of the information from that formal testimony.

In my remarks today, I will focus on a research program that

was initiated with the fiscal year 1999 defense appropriation in the

research development test and evaluation account. With that appropriation, the Department established the dedicated program element to support basic research into Gulf war illnesses and related

deployment health concerns.

The Department’s research program has three overarching research objectives in mind. We want to further the understanding

of illnesses relevant to service during conflict, including the Gulf

war deployments, we want to provide enhanced diagnostic capabilities and effective treatments for these illnesses, and we want to

support the establishment of policies and preventive measures that

minimize the risk for such illnesses during future military operations. This research program will be of the highest quality.

In this enterprise we are pleased to have the Army’s Medical Research and Materiel Command at Fort Detrick as the program

management agency. They have an exemplary record of achievement in managing medical research. The Army’s program manager

for this effort, Lieutenant Colonel Karl Friedl, is seated just behind

me. We should all thank him for his untiring efforts on behalf of

our veterans.

Turning to the funding associated with research in this area,

from 1994 to 1998 there were ‘‘special appropriations’’ for Gulf war

illnesses issues and research, and we have gained numerous insights from research projects initiated with that funding.

We have now transitioned to a formal defense research program.

This occurred with the fiscal year 1999 defense appropriation. The

funding is in the basic research account. This provides more stable

funding for systematically tackling research gaps in our understanding of Gulf war veterans’ illnesses and in force protection

issues. The program will be addressing issues in five research

thrust areas, and will support any continuation of promising leads

from the previous program.

Our program management approach includes periodic evaluation

of progress resulting in an annual tailored solicitation for research

proposals from anyone anywhere who is willing to propose to do research. This annual investment plan is carefully developed in coordination with the interagency Research Working Group. An important characteristic of this new dedicated program is the ability

to plan and implement a long term strategy of deployment health

research in support of the Department’s force health protection initiative. Indeed, establishment of a dedicated research program is a

key enabler for this initiative. The 1999 program, the first year of

our program, had four solicitations. We received 81 proposals and

we will probably make about 17 awards from those proposals. I

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have provided the current statistics and examples of the research

covered in the written testimony.

With fiscal year 2000 funding, new research solicitations will be

developed and issued. We are also initiating an investment in the

longitudinal cohort study that Dr. Mazzuchi mentioned that addresses the recommendations of the IOM’s assessment entitled, ‘‘Gulf War Veterans Measuring Health.’’ I think that the program is proving highly effective in providing

new information on the impact of Gulf war service on health-related problems and identifying new areas to explore with research,

and in prompting new force protection initiatives that provide for

medical surveillance during future operations.

Although the investment in Gulf war veterans’ illness research

has already provided meaningful results, we must be cautious in

anticipating the true impact of this research. That impact may not

be fully assessed and realized for years after this early stage of the

program and the awards have been made.

In conclusion, I believe that the organizations testifying before

you today that are engaged in research share a genuine concern for

and a recognition of the magnitude and consequences of the medical and scientific challenges before us. While there may be no quick

solutions to the health problems experienced with Gulf war veterans, the participants in our interagency Research Working Group

and our research program are genuinely committed to a responsible

and aggressive pursuit of reasonable hypotheses and to the prevention of similar illnesses following future deployments.

This concludes my remarks, Mr. Chairman, and I am pleased to

answer your questions.

[The prepared statement of Mr. Foster follows:]

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Mr. SHAYS. Thank you, Dr. Foster. General Vesser.

General VESSER. Mr. Chairman, I appreciate the opportunity to

appear before your subcommittee to review with you and its members the support the Office of the Special Assistant for Gulf War

Illnesses, referred to earlier as OSAGWI, provides to the ongoing

research into the potential causes of Gulf war illnesses.

As you know, the Office of the Special Assistant for Gulf War Illnesses does not directly undertake medical research and, with a

few exceptions, does not directly sponsor medical research. Our primary tasking when established was to find out what happened on

the battlefield. Dr. Rostker was specifically tasked to find out what

the problems are and to fix them. When the office was established

the then Deputy Secretary of Defense, Dr. John White, reconfirmed

the Department’s policy that the Assistant Secretary of Defense for

Health Affairs was responsible for the Department’s medical programs. In that regard, the Assistant Secretary of Defense for

Health Affairs and the Deputy Under Secretary of Defense for

Science and Technology represented the Department on the Research Working Group of the Persian Gulf Veterans Coordinating

Board, which coordinates pertinent medical research for DOD, Veterans Affairs, and Health and Human Services. We do have an observer who also sits with that group.

Over the last 3 years, the Office of the Special Assistant has

been instrumental, however, in funding or impacting the funds of

several medical research programs that, for one reason or another,

were not being supported by the traditional medical research funding process. Generally speaking, these did not receive sufficiently

high evaluation scores in the competitive medical review process,

but had become a great concern with a significant number of Gulf

war veterans. Our work in OSAGWI begins and ends with the veterans. We recognize, therefore, that sometimes exceptions need to

be made to the competitive medical review process. Specifically, we

believe that in the case of Gulf war illnesses, it is important to listen to our veterans and provide any assistance we can by researching claims to the potential cause and cures for unexplained illnesses that are affecting many of them.

Frankly, we have a credibility problem with some veterans who

believe that we are not funding promising research because we either don’t care about their health or that we have something to

hide. In such cases, we can demonstrate that neither is the case.

We owe it to our veterans to apply accepted medical research

standards to determine if the theory being proposed can help either

explain why veterans are ill or help in their treatment.

Let me highlight for you the projects that we have either directly

funded or have been instrumental in making sure that funds were

provided. This is in addition to the general work of our office.

Specifically, we have funded or impacted the funding of the work

of Dr. Garth Nicolson, tests for mycoplasma fermentans incognitus

strain in human blood, and Dr. Robert Haley, multi-disciplinary

pathophysiologic studies of neurotoxic Gulf war-related syndromes.

We have also funded a review of the medical records of the Saudi

Arabian National Guard by the Uniformed Services University of

the Health Sciences and the Naval Health Research Center.

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As you know, we have commissioned a number of medical literature review papers prepared by the RAND Corp. These papers

are not medical research in the traditional sense, but were important to inform and direct the work of our office. These papers, case

narratives, information papers, and our environmental exposure reports are available on the Internet at GulfLINK, and have been reviewed by the Presidential Special Oversight Board headed by

former Senator Warren Rudman.

We also helped to coordinate for DOD funds to be provided to the

Department of Veterans Affairs program in Baltimore to monitor

the health of veterans exposed to depleted uranium. I am pleased

to say that the last published results for this program, ‘‘show no

evidence of adverse clinical outcomes associated with uranium exposures at this time in these individuals.’’ Again, thank you, Mr. Chairman, for giving me the opportunity

to put the work of the Office of the Special Assistant into the proper context. I stand ready to answer any questions you or the subcommittee may have, and I ask that my remarks be made part of

the record.

[The prepared statement of General Vesser follows:]

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Mr. SHAYS. Thank you, General Vesser. Dr. Barrett.

Dr. BARRETT. Thank you, Mr. Chairman. Thank you for the opportunity to update the subcommittee on the Centers for Disease

Control and Prevention’s research programs pertaining to Gulf war

veterans’ illnesses, and to discuss the General Accounting Office’s

report.

I am Dr. Drue Barrett of the National Center for Environmental

Health. I serve as CDC’s liaison to the Department of Health and

Human Services on Gulf war issues, and I am a member of the Research Working Group of the Persian Gulf Veterans Coordinating

Board.

Our research efforts on Gulf war veterans’ health concerns date

back to 1991, with the larger epidemiologic studies beginning in

1994. I would like to briefly mention our most recent Gulf war activities and refer you to my written testimony for further details.

Two completed CDC-funded studies directly pertain to questions

raised by the GAO regarding the success of the Federal Government in documenting the symptoms of Gulf war veterans.

The Iowa study conducted in collaboration with the Iowa Department of Public Health and the University of Iowa was one of the

first population-based epidemiologic studies to document that Gulf

war veterans are reporting more medical and psychiatric conditions

than their nondeployed military peers. In fact, the study was recently described by the Institute of Medicine as perhaps ‘‘the

strongest study on Gulf veterans’ experience of symptoms related

to deployment in the Gulf.’’ The Iowa study found that the Gulf war military personnel were

more likely than those who did not serve in the Gulf war to report

symptoms suggestive of cognitive dysfunction, depression, chronic

fatigue, post-traumatic stress disorder and respiratory illness. The

conditions identified in the study appeared to have had a measurable impact on the functional activity and daily lives of these Gulf

war veterans.

Likewise, the CDC-Air Force study has significantly contributed

to our understanding of the health consequences of the Gulf war.

This study organized symptoms into a case definition, characterized clinical features, and evaluated risk factors. The key observation of the study was that Air Force Gulf war veterans were significantly more likely to meet our case definition of illness than were

nondeployed personnel. However, there was no association between

this chronic multisymptom illness and risk factors specific to combat in the Gulf war, such as month or season of deployment, duration of deployment, duties in the Gulf war, direct participation in

combat, or locality of Gulf war service.

We found that nondeployed veterans also met our case definition,

suggesting that the illness observed in this population is not

unique to Gulf war service. The clinical evaluation component

found that ill Gulf war veterans did not have clinically significant

abnormalities on physical examination or routine laboratory tests.

However, they did report a significant decrease in functioning and

well-being.

The results from both the Iowa study and the Air Force study

were published in the Journal of the American Medical Association.

In addition, both of these studies have resulted in a number of

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other articles which have been published or about to be published.

CDC is currently funding a followup to the Iowa study focusing on

evaluating self-reported symptoms of asthma. We are also funding

the Boston University School of Public Health to conduct a study

examining the relationship between cognitive function and symptom patterns among Gulf war veterans, and we are funding the

University of Medicine and Dentistry of New Jersey to conduct a

study examining case definition issues.

In addition to these current research projects, in 1999 CDC sponsored a conference to develop future Gulf war research recommendations. We brought together scientists, clinicians, veterans,

veteran service organizations, congressional staff and other interested parties to discuss and make recommendations regarding the

direction of future research of undiagnosed illnesses among Gulf

war veterans and their links with multiple chemical and environmental exposures.

The conference highlighted the importance of including veterans

in the process of planning and implementing research. A report is

soon to be released that summarizes the outcome of the conference.

Finally, I would like to briefly address the issue of coordination

of Federal research efforts. There has been HHS representation on

the Research Working Group since its inception. In addition to

CDC, the Office of the Secretary, the National Institutes of Health,

and the Agency for Toxic Substances and Disease Registry are represented. Through its membership, HHS has been involved in providing guidance and coordination for DOD, VA and the HHS research activities relating to Gulf war veterans.

In conclusion, an intensive research effort to address Gulf war

veterans’ health concerns has been mounted by Federal agencies.

The research projects funded to date represent a broad spectrum

of efforts ranging from small pilot studies to large scale epidemiology studies. In addition, numerous review panels and expert committees have evaluated the available data on Gulf war veterans’ illnesses.

As noted in the GAO report, despite these extensive research and

review efforts, many questions remain regarding the health impact

of the Gulf war. These remaining questions reflect the complexity

of assessing and predicting the health impact of military deployments.

Mr. Chairman, this concludes my oral remarks, and I would be

happy to answer any questions the subcommittee may have.

[The prepared statement of Dr. Barrett follows:]

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Mr. SHAYS. I would just make the observation it is almost like

we have two separate hearings. We had the GAO who was basically commenting on your work and had some extraordinarily significant statements, and you didn’t address any of them. You just

had your statements.

Mr. Sanders.

Mr. SANDERS. Thank you, Mr. Chairman.

Let me start off with General. Thank you very much for being

with us. Let me call on your military background, General, to ask

you a question. If the U.S. military were engaged in a major military operation with unlimited resources befitting the wealthiest

Nation on Earth, and we were fighting that war for 9 years and

at the end of those 9 years the military objectives were not one step

closer to being obtained in the sense of winning the war, would it

be fair to say that it would be in the country’s best interests to remove the generals who are in charge of that military operation?

General VESSER. Of course it would be appropriate, but one has

to ask what the objectives are.

Mr. SANDERS. If the objectives here are quite clear, they are not

complicated, the objectives that we have close to 100,000 men and

women who are ill, and the objective is we want an understanding

of their illness and we want an effective treatment, and it seems

to me 9 years later we have zero in that regard from the U.S. Government, tell me why given that rather sad track record the chairman and I and Members of Congress should not say thank you

very much for your well-meaning efforts, you have failed, we need

other people to take up the battle?

General VESSER. I would say to you what have we done. I can

speak only for my office. My office was charged to discover what

happened on the battlefield. I am not a medical person. I was a line

officer, and I am both a Vietnam vet and also served as a civilian

during Desert Storm in the desert.

I would say to you that we have developed models to estimate

who was exposed to the low levels of chemical warfare agent. We

have target notified over 157,000 veterans by letter of their potential exposure to that and to other hazards that we have looked at.

Mr. SANDERS. General, we don’t have unlimited time, and I don’t

mean to be rude in interrupting you. I am aware of that. I am not

saying that is insignificant, but using the analogy of a military conflict, we are not winning this battle. We are losing it. We have tens

and tens of thousands of people who are ill. Let us see our eyes on

the prize. What are we talking about. We are talking about treating sick veterans. We are zero step closer today it seems to me.

And I think the record on the part of the VA and the DOD has not

been a good one.

Let me speak to Dr. Foster, if I might.

I notice on page 5 and on you comment on some of the research.

Let’s deal with that.

It seems to me that in fact there have been some breakthroughs.

What concerns me in terms of the last panel, the words that we

keep hearing is lack of focus, disconnect, a lack of sense of urgency.

In other words, it appears that there have been some studies which

are making some breakthroughs and it seems to me that we have

got to put our resources into those studies. I am not happy to hear

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from Dr. Barrett that after 9 years we have concluded that some

people are ill or are not ill. We are starting with the assumption

that there are tens of thousands of people who are ill. That was

a 9-year-old discussion.

What we want to know now is what are you doing to discover the

cause of illness and what treatments have you developed.

Now on page 5 you mention Dr. Garth Nicolson’s study, and I

will be talking to Dr. Feussner about this. We have put a significant amount of money into Nicolson’s hypothesis. Is Nicolson right

or wrong. If he is wrong, we have learned something. If he is right

we may have a treatment model. Thank God we have something,

good.

Haley has come before this committee on several occasions. He

has impressed some of us as being a vigorous and intelligent researcher. He has suggested, among other things, that a genetic

trait can predispose people to Gulf War Syndrome. In other words,

what he has suggested is two people with the same exposure will

react differently. What are we doing? That is an important step forward.

He and his researchers have suggested that we can now objectively look at a brain scan and maybe tell us who has Gulf war illness and who does not. As a layman, that seems to me to be a

breakthrough. It objectifies. It ends the discussion whether somebody is ill or not ill. If we can see changes in the brain, we know

something. What are we doing to go forward on that particular

study?

Dr. FOSTER. I believe Dr. Feussner would like to speak to that

rather than me.

Dr. FEUSSNER. Yes, I would like to speak to that, Congressman.

Before I do, we have had numerous discussions in the past that

I would characterize as straightforward.

Mr. SANDERS. Yes.

And I would say that, as you know, I agree with you that we

have tens of thousands of veterans who are sick. We are treating

hundreds of thousands of veterans in VA hospitals. I believe last

year almost 300,000 Gulf war veterans received care in VA making

in excess of 31⁄2 million outpatient visits to VA.

I think there’s no question that Gulf war veterans are being

treated. I think the difficulty that we have is that they’re not being

fixed; that is, they are not being cured. And you are quite correct

that we have no cure for Gulf war veterans’ illness. That is absolutely, unequivocally correct. It’s also absolutely, unequivocally correct that we have no cure for AIDS.

Mr. SANDERS. John, let me interrupt you. We have no cure for

AIDS?

Dr. FEUSSNER. But we have treatments.

Mr. SANDERS. Here is an important distinction if you want to

make an analogy between Gulf war illness and AIDS. Researchers

today have made significant progress. If you or I had AIDS, we’d

be better treated today, have a longer life-span than was the case

10 years ago. Research has resulted in improved treatment.

What I asked General Vesser and Dr. Foster is, has research in

Gulf war illness resulted in better treatment in terms of curing

people who are sick? I think the answer is no.

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Dr. FEUSSNER. I concur.

The issue about the brain—the brain issue, I think, is quite a

pertinent one, and in my lengthier testimony—I apologize in my effort to beat the red light—I omitted my comments about our brain

imaging studies. But what I would like to say is, yes, these imaging

studies are highly important. The research portfolio at the moment

includes seven studies using sophisticated brain imaging technologies ranging from the typical one that you would encounter in

a hospital—traditional, conventional magnetic resonance imaging,

which looks at issues of anatomy; functional magnetic imaging,

that tends to look at issues of function; magnetic resonance spectroscopy and SPECT scanning, which can actually look at chemical

reactions in the brain without invading the skull.

Mr. SANDERS. Let me interrupt you and ask you this question.

Again, I’m a layman.

What seemed to me important about Haley’s work is we are beginning—I don’t know what the scientific word is, but looking at— in an objective way, if you’re looking—you can show me on a piece

of paper the brain damage of somebody and say, this person has

Gulf war illness, it seems to me to be a significant breakthrough.

Are your studies confirming what Haley has shown or are you

not?

Dr. FEUSSNER. The studies haven’t been completed yet, unfortunately. What—but I can tell you what the studies are focused on.

The studies are somewhat different than Dr. Haley’s. Dr. Haley focused on a general chemical in the brain that’s dispersed throughout the brain and is a potentially general marker for nerve cell

damage.

The studies that we have looked at focus on parts of the brain

that are known to be associated with memory processing called a

hippocampus and others, since many of the patients complain of

having memory dysfunction, et cetera.

The other major focus of the research is looking at chemical

neurotransmitters; that is, chemicals in the brain that allow cells

within the brain to communicate among themselves and with other

parts of the brain.

But there is research in the pipeline, yes, sir, that will confirm,

advance, et cetera, the results of Haley’s work.

Mr. SANDERS. I want to say something that while I have been

very critical, and I think quite rightly, of the DOD and VA, I think

Dr. Feussner is a bright light and probably will get you fired. But

nonetheless I think he is at least one person trying to get forward.

Here is the point; let’s get back to the treatment aspect. Presumably, if Haley is right, maybe—I don’t know this, but if he is

right—there might be a treatment that can be built around that

understanding. I mean, don’t we want to develop a treatment? How

close are we developing a treatment based on the brain research

that you’re doing?

Dr. FEUSSNER. We’re not close to developing treatment based on

brain research that anyone has done to date. But I think your assertion is fundamentally correct; that is, you don’t want to give a

patient with hypertension insulin, because you’ll do much more

harm than good. And one of the conundrums of the research process is, fundamental understanding about some of the mechanisms

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might allow you to make better judgments about treatments that

are likely to provide more benefit than treatments that are likely

to do more harm. And that’s the pathway we have taken, as you

asserted earlier, with the mycoplasma idea. Those are the pathways we are taking as a matter of fact with the EBT trial.

Congressman Allen commented on the fact that the working case

definitions could actually be useful, and I would like to point out

that that is, in fact, correct; and in both our treatment trials those

working-case definitions are being used to select subgroup of patients for treatment, and what we have observed is that those patients are quite sick, based on the measures we’re making of their

health status.

Mr. SANDERS. Let me ask you this. Let me shift gears a little bit

and go to the issue which Mr. Allen, among others, has raised; that

is the issue of multiple chemical sensitivity. Again, you’re talking

to a Member of Congress for whom this is not an abstract issue.

I have talked to hundreds of veterans in the State of Vermont. As

you know, I think Vermont probably ranks the highest in the country in terms of participation in the mycoplasmic study. We have

worked very hard to involve people in that study and to work with

veterans.

A veteran in Springfield, VT, tells me if he is exposed to his

wife’s perfume or walks into a grocery store, he becomes ill. It

sounds to me like this is a reasonably conventional symptom of

what we call ‘‘multichemical sensitivity.’’ What are you doing to

treat, to acknowledge that problem and to treat that problem?

I have a nightmarish feeling that there are thousands of veterans who are walking around today who probably have a lot of toxicity within their systems or damage in their systems as a result

of exposure to toxicity, who continue to get exposed to the food they

eat, the air they breath, the work that they do, to toxic elements

that perhaps make them iller than they otherwise should be if they

avoid that type of environment and yet they are not told about

that.

What are we doing to understand and treat multiple chemical

sensitivity? There are a number of studies—perhaps we’ll hear

from Dr. Miller in a little while—that suggest that what we’re seeing in some of our Gulf war veterans are not dissimilar from what

doctors are seeing from civilians who have been exposed to excessive amounts of chemicals. Now, this is an issue not just for Gulf

war veterans but for the population at large. What are we, in fact,

doing on that issue?

Dr. FEUSSNER. The research that’s ongoing in low-level chemical

exposures and low-level chemical toxicity is small. I think probably

fewer than a dozen projects that look at efforts to understand how

exposures to various chemicals, low doses of chemicals might affect

various body systems. We have no treatment trials at the moment.

Mr. SANDERS. It seems to me, Dr. Feussner, that is a great lack.

That is one of the important hypotheses out there.

Why is the VA not going forward on it?

Dr. FEUSSNER. Well, in part, I think you already know the answer to this question, but let me try to answer it nonetheless. I

think there are two issues. One of the issues is that some of the

treatment strategies that are proposed require unique environVerDate 11-MAY-2000 08:58 Dec 27, 2000 Jkt 000000 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 C:\DOCS\67151.TXT HGOVREF1 PsN: HGOVREF1
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mental chambers, and the Department has no or virtually no such

facilities at the moment. So it doesn’t permit any research that one

would want to do—— Mr. SANDERS. Let me interrupt. I don’t mean to be rude. I’m a

fan of yours. I’m not being rude here, but let’s stop for a moment.

You’ve spent, gentlemen, how much, $130 million? Almost everybody is of the opinion that one of the causes of Gulf war illness

may be the fact that our veterans were exposed to a very toxic environment. There’s no doubt about it. We, generally speaking, call

that type of process multiple chemical sensitivity. How could it be

that when an environmental chamber costs a few million dollars

and you need that environmental chamber to do the work that

needs to be done to fully understand multiple chemical sensitivity,

that after spending $120 million-plus, we still do not have that

chamber.

Doctor.

Dr. FEUSSNER. Well, I don’t know the answer to that question,

Congressman. What I would say is that in—with regards to our

Environmental Hazard Research Center in East Orange, in East

Orange, that the low-level exposure research that’s going on there

avails itself of the collaboration with the Robert Wood Johnson

Medical School, which does have access to such chambers, and

MCS research is going on there using the university-based chamber.

Mr. SANDERS. Let me interrupt you again.

Dr. FEUSSNER. Now, the other issue, however—— Mr. SANDERS. Sorry. Let me interrupt you again. I open it up to

any of the five people up there.

Tell me why if exposure to chemicals is considered to be one of

the important causes, what might be one of the important causes

of Gulf war illness. If an environmental chamber is absolutely

needed to better understand this problem, tell me why for a few

million dollars the U.S. Government does not own one environmental chamber? Can anybody answer me that question?

Mr. Chairman, I must tell you I put in the last——

Dr. FEUSSNER. Congressman, if I may say, I believe the Federal

Government does own such chambers. I’m not specifically aware of

DOD, but I’m quite aware that the EPA site at the University of

North Carolina in the Research Triangle has, I believe, such facilities.

Mr. SANDERS. I am not aware of that. I may be wrong on this.

I will——

Dr. FEUSSNER. But I think in terms of——

Mr. SANDERS. Even if they do, where is the collaboration? Why

are you not availing yourself of that chamber if, in fact, it does

exist? How many years do we have to go through the routine of

talking about multiple chemical sensitivity and understanding it?

Now, I do understand it.

Here’s the root of the problem, I think—I know I’m taking up

much too much time—multiple chemical sensitivity or multiple

chemical illness is a controversial definition, right? There are some

people in the medical world who simply do not agree with it, I understand that, but it seems to me in fairness to Gulf war veterans

who are ill, we have got to pursue every avenue that is out there.

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Dr. Feussner, what you are telling me is, you think there may

be a chamber, but certainly it is not a chamber that I gather any

of the research here has worked with.

I would mention, Mr. Chairman, in the last military appropriations bill, I put in some language—I guess, calls for the need for

a chamber, but I would hope very much that with all of the money

we are spending, we will build a chamber so we can better understand multiple chemical sensitivity. I think it’s an outrage that we

don’t have one.

Dr. Feussner, let me give it back to you. Do you agree?

Dr. FEUSSNER. Well, I think there’s no question that having a facility available certainly would facilitate use of that and subsequent research. You also are aware that that problem confounding

us, we are receptive to research in this area that specifically focuses on treatment trials, I think, all of us that are receptive to

that research—NIH, DOD, and VA.

Mr. SANDERS. Tell me about the research—all right. He gets

sick—I keep pointing to my colleagues here—if his wife has perfume. I don’t know if you talked to them, but in Vermont we have

veterans. Dr. Vesser, he is nodding his head. That is a symptom

that you picked up, right?

General VESSER. I have talked to over 3,000 veterans in our town

halls that come to tell us what their problem is, and probably another—my teams have probably talked to another 20,000. And this

is one of the symptoms that we hear, sir.

Mr. SANDERS. Good. So we’re in agreement. What are we doing

to better understand that and treat that so a man can be with his

wife who wears perfume? What have we learned from that all of

these years?

Dr. Vesser, you want to help me with what we’ve learned? I’ve

heard it; you’ve heard it; what have we learned? If a guy gets sick

exposed to detergent or perfume, what have we learned?

Who wants to tell me what we have learned? What are we doing

to treat that?

Dr. FEUSSNER. I don’t know that we’ve learned very much, but

what I would say on the other hand is that this issue suffers from

some of the same problems that Gulf war veterans’ illnesses have,

vis-a-vis sharply defining the patient population, defining interventions that are testable and that can be given homogeneously across

populations and then having explicit outcome measures.

Mr. SANDERS. John, will you promise me this—and you’ve been

a man of your word: It sounds to me like we’re really lacking going

forward, and I understand that it’s controversial, and I understand

that some of the researchers in this area get criticized and they

don’t have all the peer reviews and everybody else—millions of

Americans.

Dr. Vesser, you have heard the same thing that I have heard,

right?

General VESSER. That’s correct, but it’s General Vesser, sir, not

doctor, with all due respect.

Mr. SANDERS. I’m sorry. You’ve heard the same thing and you

have just told me by your silence that we’re not doing very much

in responding to those concerns that the veterans have?

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General VESSER. Well, my own office is trying to do some environmental reports. One of them will deal with pesticides, because

we know that all soldiers who served in the Gulf war were exposed

to pesticides, one chemical that we are concerned about, so we’re

trying to get some information about potential dosage.

Mr. SANDERS. Dr. Feussner, can you make a promise to this committee today that you will make multiple chemical sensitivity a top

priority, that you will work with us for an environmental chamber

so that we can begin to treat and understand that problem better?

Can you make that promise or commitment to us?

Dr. FEUSSNER. Yes, I think that I will—I think, sir, I have tried

to work with you on this effort in the past and, yes, I will continue

to work with you on this effort.

Mr. SANDERS. You have worked with us, and I applaud you for

that. But we have not worked effectively—you have worked very

well on the mycoplasmic theory. I applaud you.

We have not worked effectively on MCS.

Dr. FEUSSNER. Which we have not gotten to, yes, yet.

Mr. SANDERS. You will make that commitment to us?

Dr. FEUSSNER. Yes, sir, I will certainly continue to work with

you.

Mr. SANDERS. Will you support our effort to fund an environmental chamber?

Dr. FEUSSNER. I believe I’ve made that commitment to you in the

past, that if there was a way to find the money, I would be with

you.

Mr. SANDERS. But this is what is a little bit crazy. We’re talking about spending $130 million. The Congress has not been cheap.

We’ve allocated a lot of money. There is money out there; you can

make that happen if you want.

Mr. Chairman, you’ve been very gracious here. I’ve gone three

times over my limit here. I thank you.

Mr. SHAYS. I will try to get you all out before we have to vote,

so you don’t have to wait for us.

You are all parts of various departments who are part of the coordinating working group, and not only do I feel like the GAO’s report before yours was ignored by your statements; but I also don’t

have a sense of comfort that you are part of one group.

Who is in charge right now of the working group? Dr. Feussner.

Dr. FEUSSNER. I am sir.

Mr. SHAYS. How does the system work? It rotates every 3 months

or what?

Dr. FEUSSNER. No, sir. I became chairman of the Research Working Group in 1996, and I have been chair of the Research Working

Group through the entire subsequent time.

Mr. SHAYS. I get the feeling that OSAGWI is basically the

10,000-pound gorilla in this group though. Hearing from you, General Vesser, it’s like you’re just getting an assessment of where our

soldiers are coming from and that’s the extent of it. Isn’t your agency basically doing most of the funding?

General VESSER. We have spent a lot of money on our investigations and all that work hasn’t gone solely on investigations. The

Research Working Group, as we understand it, is concerned primarily with medical research and research, scientific research.

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Mr. SHAYS. Is it your testimony that you don’t do 90 percent of

the research projects?

General VESSER. Ninety percent of the research projects?

Mr. SHAYS. Of the $121 million, how much are you spending?

General VESSER. OSAGWI isn’t spending any of that, sir. That

money is in a separate account.

Mr. SHAYS. You’re in charge of coordinating DOD’s effort, correct?

General VESSER. Dr. Rostker is in charge of coordinating DOD’s

efforts, but they do not extend, as I said in my prepared statement,

to the conduct of medical research, the research that the Research

Working Group is responsible for.

Mr. SHAYS. I just want to pursue that. You work as the Deputy

to the Special Assistant for Gulf War Illnesses; your office does

this?

General VESSER. That’s my office, yes, sir.

Mr. SHAYS. Are you telling me that your office makes no determination on who gets funded and who doesn’t get funded?

General VESSER. That’s correct. We’re not voting members of the Research Working Group in terms of funding these $121 million of

projects you’ve heard about. We’re concerned with modeling to find

out what soldiers who served in the Gulf might have been exposed

to in terms of low levels of chemicals, funding the experiments at

Dugway, funding the chemical rocket warheads that had to be

made, trying to define the hazards that people—— Mr. SHAYS. How much money do you spend on research and

studies?

General VESSER. Research per se? I don’t have the figure right

in front of me, but I’ll provide an answer for the record, sir.

Mr. SHAYS. Give me an idea.

General VESSER. I’d say all together, thus far, on the subjects

we’re talking about, we’ve probably spent something on the order of $10 to $13 million, including the travel for people to come in and

help us determine where our soldiers were, on declassification

of——

Mr. SHAYS. Let me say this to you. I’m going to say this to each

and every one of you.

Every accusation that the GAO made about the working group

or your participation in the working group stands as fact unless

you refute it—stands as fact. Now, one of the statements they said was, first, DOD, VA, and HHS spent over $121 million in research

investigation in fiscal 1997 and 1998. DOD’s efforts account for 90

percent of the total.

Now, you are my representative of DOD. Dr. Foster and Dr.

Vesser, do you guys coordinate? I mean, who is in charge here?

Dr. FOSTER. The research account that I have oversight for is the

investments coordinated through the Research Working Group, and

we actively solicit as part of the research strategy the input from

the VA and Health and Human Services and from OSAGWI, and

the actual investment is tailored to their advice.

Mr. SHAYS. Does that constitute 90 percent of the funding?

Dr. FOSTER. No.

Mr. SHAYS. You were here. You heard this statement. If this

statement is inaccurate, tell me it’s inaccurate.

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General VESSER. I believe that statement is inaccurate, Mr.

Chairman, because it includes all the money that we spent on investigations, on other types of scientific efforts that are not medical

research that comes under the Research Working Group.

Mr. SHAYS. I’m sorry, I’m going to have to hold you over. I’ll go

vote and I’ll come back. I thought I could get us done.

I’m sorry. We’ll stand in recess.

Why don’t we do this? Why don’t you—I’ll be back here in 20

minutes.

[Recess.]

Mr. SHAYS. I’d like to call the hearing to order. When I was gone,

I was just trying to think what my frustration is, and I don’t like

to use that word often. One of the things I realize is that I can be

up here in the chair, and I can yell at witnesses and I have tried

not to do that. I have tried not to do that for the many years I’ve

been chairman. I’ve tried to realize that I have a special advantage

up here, and I can just throw stones and I don’t have to answer.

But it does strike me as not unreasonable that if you had the

GAO that basically tore apart the working group and each of you

had your own statements that somehow are self-contained, that

there would be some recognition that it deserves to be responded

to. And so I do think it’s fair to say that GAO tore apart the working group, and now I think the working group needs to respond.

And I began to realize that I think for instance, Dr. Feussner,

you’re speaking from the perspective of the VA; and you’re speaking, Dr. Mazzuchi, from the DOD’s perspective; and Dr. Foster

from DOD’s perspective; and General Vesser’s from DOD’s perspective; and Dr. Barrett from HHS’s perspective. But you’re part of a

working team that just got clobbered this morning, and I want, before we end, to know where you agree or disagree. And, for instance, in the document that they provided, they share with us the

fact that you had certain objectives and you haven’t responded to

any of them that told us where you are on them.

So I want to know, Dr. Feussner—I’m going to go right down the

list—I want to know where you agree and disagree with GAO.

Dr. FEUSSNER. Sir, I haven’t seen the final GAO report, but I

have seen the GAO report that they shared with our group 6

months ago, and VA did respond to the criticisms of the GAO.

One of the criticisms—— Mr. SHAYS. Let me back up a second, Doctor. You were here this

morning. You did hear what they said today.

Dr. FEUSSNER. That is correct.

Mr. SHAYS. OK.

Dr. FEUSSNER. My full statement does refer to comments that

the GAO made earlier.

Let me say we did concur with the GAO criticism that we have

not summarized perhaps optimally the status of the research that

has been going on in the Research Working Group on the one hand.

On the other hand, GAO has noticed correctly that most of the research is ongoing and not complete. And it’s really been only recently that a series of research products have become available.

One of the reasons for not synthesizing comments about the

original working plan is that the research results are just now becoming available. We have given updates in the annual report to

97

Congress, that says what has gone on recently; and we have concurred with the GAO recommendation that we develop this synthesis during the course of this fiscal year, and we will do that.

Now, several of the activities that are going on in the research

arena have had, I think, important results, and several of those important results I alluded to in my testimony. Unlike the GAO, I

think that the epidemiological research has been quite important

and quite beneficial. It sets the context for Gulf war veterans’ illnesses. It shows preliminary information about mortality, birth defects. It shows preliminary information about health status, and

that’s very valuable information.

When the GAO criticizes us for saying that the research work

needs—that we need to continue the work, they don’t seem to appreciate that many of these exposures have long latencies, so that

while I can say today that the mortality study has shown no increase in disease-specific mortality, that’s not a completed statement. That’s—that mortality observation needs to be made for 5,

10, 15 more years.

Similarly, with depleted uranium, we can say that for patients

known to have embedded DU shrapnel, that they are mobilizing radioactive urine—excuse me, sir, radioactive uranium. They are excreting it in their urine. At this point in time, it has caused no ill

effects on the kidneys and it has caused no other ill health effects,

but it’s too early to say that the depleted uranium is harmless. We

need to keep those patients under surveillance.

The situation with the oil well fires and the measures of the hydrocarbon, potential hydrocarbon toxicity is very helpful. The National Cancer Institute study, a small study of soldiers from Germany to the Gulf, immediately after the war back to Germany,

showing more toxicity while in Germany than in theater—a very

useful observation.

The pyridostigmine bromide, we were concerned 2 years ago

about penetration of the blood brain barrier. GAO might say that

we are duplicating this research. We are not duplicating this research; we are replicating the research.

I can’t tell Congressman Sanders if the result from Dr. Haley is

a breakthrough. It could be. But if two, three other investigators

make the same observation, if this looks like it’s a reproducible observation, then it could be a breakthrough. So I feel like, in many

areas we’ve made substantial progress.

In the infectious disease area, this research plan that we put together is organized by exposures, yes, but it’s also organized by research strategies; and it provides guidance, but it also provides

flexibility. We, in essence, have diminished the research commitment to infectious disease research because it seemed to be going

nowhere beyond the issue of leishmaniasis. Well, we have changed

that with the business being raised about mycoplasma, with a

question that chronic antibiotic therapy might be able to affect

that. We revisited that issue.

So in my sense, we have difficulty because the research portfolio

is complex. It’s not just one virus causing one illness. There’s a long

latency with many of these exposures and the spectrum of research

goes from animal research, basic research, to population-based epidemiology to patient-based treatment trials.

98

Now, we’ve talked with GAO about that and we are working

now. I think the criticism about the synthesis is fair with the caveat that much of the work is just now being finished, so we actually now have some things to synthesize. We will produce that this

fiscal year, no later than September 30.

The other responses with regards to the coordination, I do disagree with and we disagreed for the record. All of these groups are

represented on the Research Working Group. We discuss the research products; we discuss new research directions.

Mr. SHAYS. In DOD, we have three people from DOD. Who on

DOD is on that board? So both of you serve?

General VESSER. We have an observer.

Dr. FEUSSNER. Dr. Kilpatrick was on the board as an observer.

Mr. SHAYS. How does it work? Is it one from VA, one from HHS

and four or five from DOD? How does it work?

Dr. FEUSSNER. No. There are several from DOD. There are three

from VA. There are representation from EPA and ATSD, the toxic

substances and disease registry. There is NIH, the Secretary’s office, CDC. So there are multiple representatives on the Research

Working Group from each of the departments.

Mr. SHAYS. Before I’m concluded, I have to have a better comfort

level of the coordination between OSAGWI and the working group,

because I really feel that OSAGWI is basically kind of outside in

a tremendous capacity to dominate and just do some on their own.

But that’s my feeling and your response is helpful. Thank you.

Dr. Barrett, I would like to know where you agree and disagree

with the GAO findings.

Dr. BARRETT. I think the criticism that we haven’t provided any

information that addresses the objectives is unfair criticism. I think

there is—there’s been numerous publications that have addressed

many of the objectives. It may not—like Dr. Feussner has said, it’s

not synthesized in such a way that it’s—specifically states objective

one and ‘‘this is what we found,’’ but certainly an example is the

objective regarding prevalence of symptoms and understanding the

conditions.

Now, there is a criticism that we should be beyond that. Well,

we do have current projects that are trying to move us beyond that.

The New Jersey study is looking at the issue of stability of symptoms over time, how have the veterans’ health conditions changed

over time? The Boston study is trying to look at the issue of brain

functioning and how brain function relates to this complex of symptoms.

Mr. SANDERS. May I interrupt for 1 brief second, Mr. Chairman.

What I’m hearing from both Dr. Feussner and Dr. Barrett is interesting, but it is missing one point and that is one word called

‘‘treatment.’’ What you’re working for is to help close to 100,000

people who are ill. It is interesting and it is important to know

prevalence, et cetera, but if there is somebody over there who tells

you that they have short-term memory loss or blinding headaches,

what are we doing?

Now, I know—I would hope that Dr. Feussner would say that if

the clinical trial with doxycycline goes well, you may in fact have

a treatment for some of the symptoms. That is good news.

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Tell me one other example where you’re ready to have a treatment, based on $121 million of research. Do I hear any other?

Dr. FEUSSNER. The EBT trial.

Mr. SANDERS. But that’s more disease management in fairness.

General VESSER. I think, sir, that it’s useful to talk about outreach, which is one of our activities. The nearly 30 town halls we

have conducted, we bring together representatives of the VA, of the

military hospital or treatment facility in the area so that they can

answer veterans’ questions directly in terms of referring veterans

who have had difficulty getting treatment. Now, that’s not funded,

as I said earlier, through research funding, but rather through

O&M funding.

Mr. SANDERS. General, we can refer people all we want, but if

there is no treatment, there are rather limits in terms of what

we’re referring.

Now, it’s not complicated. If Dr. Feussner’s clinical trial is successful, as I understand it, we will have a treatment for some veterans. That is good influences. What I’m asking you is, what other

treatments are you developing right now? All the research you’re

doing is important, it’s good, but it’s not going to help make one

veteran better tomorrow; and that’s what they want and that’s

what our job is.

Mr. SHAYS. We’re going on two tracks here, so I’m going to suspend that. I’m going to suspend the answer to that question and

you’ll have time to think about how you further want to answer it

but I just want to be clear as to, in your mind, where you agree

with GAO and where you disagree. And I’m getting a better sense

of it.

Dr. Barrett, had you concluded your response?

Dr. BARRETT. I think regarding the question about whether we

have information of how veterans are currently faring, I think

again there is research going on in that area. Again, the projects

are starting to get to the end of their funding period, so hopefully

some results will be coming out soon on that regard; but again, this

research takes time.

Mr. SHAYS. Now, among DOD, first let me be clear as to your office, General Vesser. My view is that you are basically—your office

was established to coordinate DOD’s effort in dealing with Gulf war

illnesses. If I’m incorrect, which I could be, I want it explained to

me.

Is that accurate or not?

General VESSER. We are the single point of contact for the Department for Gulf war issues, sir, but in effect, as I said in my

opening statement, the tasking order that came from the then-Deputy Secretary of Defense John White gave us that authority in all

areas except medical programs, and that was seen at the time to

include programs for medical research which lies specifically with

health affairs and with the, as I indicated in my opening statement, with Mr. Foster’s office or Dr. Foster’s office.

I would go on to note that our person on their board who coordinates has made available the results of all our investigations as

they became available and kept the Research Working Group apprised of the areas that we were working in, but we are not voting

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members on the Research Working Group, so consequently we have

no direct say in the award of the contracts for medical research.

Mr. SHAYS. But DOD has votes in there?

General VESSER. Dr. Foster and Dr. Mazzuchi.

Mr. SHAYS. But you basically oversee their activities. Is that not

true?

General VESSER. We do not oversee that activity because that activity is overseen by the Assistant Secretary of Defense for Health

Affairs, according to the tasking division that was made by the

Deputy Secretary of Defense.

Mr. SHAYS. I have no vested interest one way or the other on

whether what the GAO says is accurate or inaccurate. I’m not trying to prove they’re accurate. I just want to know whether they are

accurate or not. I want to know if this statement is accurate.

First, DOD, VA, and HHS spent over $121 million in research

and investigation in fiscal year 1997 and 1998. DOD’s efforts account for 90 percent of the total. That’s the statement that Mr.

Chan made. Over half was spent by DOD’s Office of the Special Assistant for Gulf War Illnesses, which I will refer to as OSAGWI,

which is your office.

Now, is that accurate?

General VESSER. That statement is accurate, but it overlooks the

fact that there are two different kinds of money. One is R&D

money and second is operations and maintenance money. When OSAGWI was established, initially we received $4 million

from Health Affairs in O&M money. Subsequently all our funding

has been from Defense-wide O&M. We pointed this out to the GAO

in additional Department of Defense comments when we commented on their draft report. This is a distinction that they do not

recognize evidently.

Mr. SHAYS. Now, in that report, on page 15, it says OSAGWI’s

activities have not been effectively coordinated with those of the

Research Working Group in order to maximize the efficient use of

resources. We found conflicting information about the nature of

OSAGWI’s work and whether it should be coordinated; specifically,

the Research Working Group and OSAGWI’s officials told us that

OSAGWI’s activities involve investigation, not research, and therefore are not subject to coordination. Is that something that basically I should leave on the table? Is that what you’re telling me?

General VESSER. I’m telling you, sir, that we have done very little medical research other than the people we have responded to

veterans thinking they had things that might provide some insight

into what was making them ill, that our work has primarily been

investigations.

Mr. SHAYS. How much money have you spent on investigations?

General VESSER. Investigations and scientific work done associated with that, the creation of meteorological models, the use of diffusion models, bringing people together for conferences to find out

where our troops were located. Those are the kinds of things we’ve

been doing, sir.

Mr. SHAYS. Those are very important things to do, General. I am

just trying to assess if that is part of the $121 million or not.

General VESSER. That is part of the $121 million that they’re reporting to you, yes.

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Mr. SHAYS. And it is your view that all of that effort does not

have to go before the Research Working Group?

General VESSER. That is correct, because it is a different science.

It is focused on trying to understand and make sense of what happened on the battlefield.

Mr. SHAYS. I’m going to release the floor in just a second, but Mr.

Chan’s No. 2 point that he wanted to make was, most research is

ongoing in mid-1999. Of the 151 research projects funded by the

Federal Government, 30 percent have been completed while

OSAGWI had received 19 of the 21 reports due from its contractors. It had publicly released only six of them. Of these reports, 14

had remained in draft or review status for a year or longer.

Now I want to know, are those investigative reports or research

reports?

General VESSER. I believe that some of them are investigative reports and some are research reports. The Presidential Advisory

Committee told us to use risk communication in communicating

with veterans. This is how one communicates bad news essentially

without frightening the individual who is receiving that news.

All of the work we do goes through a risk communication specialist to make certain that it has been looked at from that perspective. In addition, we often receive reports from contractors which

are currently undergoing thorough scientific review, and we get a

draft; and until the thorough scientific review by other like experts

is complete, there’s no way that those reports can be released.

In addition, we—— Mr. SHAYS. Why not?

General VESSER. Because they may lack credibility, take our first

report on the Khamisiyah plume. We were told by the Congress we

had to have that work peer reviewed by the Senate investigation

unit, because they felt that it was not properly peer reviewed.

We’re refining that work now and when the work is refined, it will

have been peer reviewed and those things take time, sir.

Mr. SHAYS. General, you just touched a real sensitive chord. We

had a witness years ago who was going to come in on a Tuesday

to point out that the DOD had not been telling the truth that our

troops had been exposed to defensive chemicals in Khamisiyah. We

had this individual with his video and at 12 noon on Friday before

our Tuesday hearing, DOD announces at 4 p.m. they will have a

press conference in which they announce that our troops were exposed. And that’s why you just touched a real sensitive chord.

So when you talk about how you want to deal with Khamisiyah

and everything else, you lost me.

General VESSER. I’m sorry I wasn’t in the business then, sir, but

I wouldn’t have done that. I think that’s not the way to behave.

Mr. SHAYS. Thank you for saying that.

I will just conclude by asking you this. Of these 14 reports that

are in draft or review status for over a year, how many of them

relate to your investigative and how many relate to the medical research side?

Dr. Foster, can you answer that?

Dr. FOSTER. If the 14 reports were commissioned by OSAGWI,

then none of them would be medical research.

Mr. SHAYS. So these are all relating to the investigative side?

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General VESSER. We’d have to get you an answer for the record

by identifying the reports that the GAO has identified and giving

you their exact status, sir.

Mr. SHAYS. Thank you, General. Dr. Foster, I’m going to give you

an opportunity to then clarify the issue of these reports. Are all the

medical research investigations, all medical research, that goes

through your office?

Dr. FOSTER. Medical research funded by the Defense research appropriation go through my office, yes. If there are clinical studies

done in the health care side of the House, that is managed and

monitored by the Assistant Secretary for Health Affairs.

Mr. SHAYS. Which is not OSAGWI?

Dr. FOSTER. Not OSAGWI, no. So the medical community is together through the ASBREM Committee but they would fund clinical type investigations with operations and maintenance money. I

fund primary research science from the research appropriation, and

the appropriations that we received specific to Gulf war illness are

summarized on page 4 and those are the—those, up through 1998,

are——

Mr. SHAYS. Four of——

Dr. FOSTER. Of my written testimony. Those are research and development test evaluation funds that we oversee.

Now, all those were special appropriations. They weren’t part of

the President’s budget request. So they were added to the research

account in those fiscal years.

Mr. SHAYS. If I were you, Dr. Mazzuchi, or even General Vesser,

I think my response to—if I’m hearing you correctly, and I want

you to correct me if I’m stating it incorrectly, I would say that GAO

is crazy if they are implying that these 14 studies referred to anything dealing with the working effort of this Research Working

Group; that all the medical research we have disclosed, we are not

waiting for draft review status, that is, something dealing with investigations of OSAGWI which are not being or should be—I won’t

say ‘‘should be,’’ but are not coordinated.

Is that—are not part of the research effort. Is that accurate or

not accurate?

Dr. FOSTER. That is correct, and I would say if you ask the question coming down the line, that I feel that the GAO has just basically confused the issue in the title of the report having to do with

research because we have mixed together research and what is normally termed ‘‘general medical operations’’ into one lump, and it’s

very difficult for you all to separate the two in your minds.

Mr. SHAYS. What stands is all of your comments that their recommendation that we need a better assessment of where we’re at,

and that will be done this year, will be done?

Dr. FEUSSNER. Yes, sir, this fiscal year.

Mr. SHAYS. Fiscal year by the end of September?

Dr. FEUSSNER. Yes, sir.

Mr. SHAYS. Thank you.

Dr. FOSTER. If I could leap in for one other thing, I would say

the other area that I have a disagreement with the GAO is their

assertion that the epidemiology studies are not useful. They’re absolutely essential to the scientific community.

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We have to understand what the medical conditions are out there

so we can formulate hypotheses to be tested. And they were going

down an argument line that the investment by the VA and by the

health care part of DOD was not very helpful to us, and I fundamentally disagree; and that’s why the Research Working Group

is so important because you have the medical practitioners, basic

scientists and other folks, including the studies folks from

OSAGWI, working together to try to define the set of problems so

that we can bring to bear research clinical studies, and health care

type of approaches to helping the veterans, in order to understand

the fundamental phenomynology.

And it’s a good team. I’ve only been together with this 11⁄2 years,

and coming from the outside of into it, I thought, great, this is really going to help me in overseeing the medical research account and

the investment strategies that will develop. I can’t imagine another

venue since these folks see the patients that I could imagine that

would allow me the insight to help focus the research.

Dr. MAZZUCHI. If I might followup on that, one of the pieces I

mentioned in my oral testimony, as well as my written testimony,

was the Millennium Cohort Study. I think that is a very pivotal

piece for the Department.

One of the issues that has occurred over and over—and we agree

with the committee—is, it’s very difficult to assess someone’s

health status or to understand what happened to a person in a deployment if you don’t have good baseline data and if you don’t follow them. What we do not know and what we are—this cohort

study which we believe will give us the information—going to do

is to follow a cohort of both deployed and nondeployed military personnel and then to follow people who come into the military in

2001 and follow their health status noting their different deployments because one of the issues that epidemiologic research has

shown us is that while there seems to be no new disease entity,

clearly people who have gone to the Persian Gulf have suffered conditions and symptoms and diseases at different rates. What we

need to know is, is it deployment itself or a combination of deployments or multiple deployments that adds to that? We don’t have

the answer to that.

The epidemiologic research that is being funded and very well coordinated with the Research Working Group, I think it seems will

be able to give us those answers.

In addition, I think one of the major lessons learned from the

health community from the Persian Gulf experience is that we

need not only to get baseline data, but we need to follow groups

over time and then we need to find if there are interventions that

work. As Mr. Sanders has said, we need to apply them.

We are working very hard with the VA to develop a practice

guideline which will help our primary care providers both diagnose

and recognize early symptoms of—I’ll lump them into chronic fatigue syndrome-type symptoms so that treatments can be effected

earlier, which ought to mitigate against chronicity of chronic disease symptoms. All of these things flow from the epidemiologic research.

The other thing I want to say is, I agree with Dr. Foster. I believe that the General Accounting Office confused—because they

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used the word ‘‘research’’ in a broad sense, confused the effort I believe, and I’ve been with the Department for almost 30 years, that

the research effort under Dr. Feussner’s guidance has been unbelievably well coordinated and well thought through.

There are other efforts that are complementary, not contradictory

to these that are being led by the OSAGWI group to look at veterans’ complaints to find out what actually did happen on the battlefield. You could certainly call that research, but when we speak of

research, we’re talking about R&D dollars, research and development dollars, that are used in the scientific process for medical research. I think that’s where some of the confusion has come in.

That’s why you have two very different stories from our group versus the GAO group, because we’re talking more narrowly.

Mr. SHAYS. Can I—just for the record, I am getting a little uneasy. Some of the RAND studies were medical studies; they weren’t

investigative studies.

General VESSER. All of our studies were reviews of medical literature in the sense that although—in some sense they could be

characterized as medical. They were an effort to inform the veterans. The Presidential Advisory Committee had about one paragraph on a number of topics.

Mr. SHAYS. But the problem is that some of these are not even

out. So if the effort is to inform the veterans, they are not even out.

General VESSER. Five of the eight that we have commissioned

from RAND are out. And the others are slow. The reason some of

these are slow—and I didn’t go into that—is that some of the authors are very elderly and one is fighting cancer. This has slowed

down release of some of the reports.

In addition, some of the authors are doing more than a single report. So they are switching from one report to another, but essentially what they are doing is compiling medical literature so that

veterans have an idea what it is that the medical community says

about stress or PB or oil well fires or depleted uranium; so there

are facts that are available.

Mr. SHAYS. Let me just say that just introduces a whole new

level of discomfort that I have because you have responded that

some of these are medical. Their purposes are to inform our soldiers, but it would strike me that they would be coordinated with

this working group. I am just going to share with you I have some

real discomfort.

In other words, in my judgment there is enough truth to the

GAO’s concern, and maybe technically I can agree with you that

one is medical research and one is slightly different. They do come

perilously close and do seem to invite that there would be some coordination.

We could go on longer. I am going to suspend my time with you

to get to the third panel. I will concur with you and recognize you,

Mr. Sanders. You may have as much time as you want.

General VESSER. May I make one comment.

You asked what we disagreed with in the GAO report.

We in OSAGWI do not feel that the GAO has demonstrated that

our contract awards were in fact improper. We have made every effort to comply with the law, to use the system that is established,

and contracting officers award contracts, not the sponsoring office.

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On the other hand, the GAO points out we have the responsibility in their comments on the material we submitted to them for determining its requirements for support, a process that in one instance resulted in naming a preferred contractor and in another led

to an overly broad statement of work. I would say that the guidance on this systemic process says that the contracting officer will

review your requirements package for scope, accuracy, and completeness. Corrections and/or clarifications may be required.

So we did everything we could at the time. I would also note that

with respect to the preferred contractor, we had a little bit of difficulty figuring that out because the contractor that they cited had

four task orders, tasks to be performed. We believe that they are

referring to the requirement that we get a risk communication

service provided. That contract was posted. We had one inquiry.

Others couldn’t provide the expertise. There was only one contractor who could provide the expertise.

Last, I would say that we are sensitive to the GAO recommendations that we use a different contract vehicle for the BDM-TRW

task. Consequently, we are currently working with Defense Supply

Services and BDM-TRW on the creation of a blanket purchase

agreement that will combine several GAO schedules to provide the

services that we currently obtained through the MOBIS vehicle

which they are critical of.

By creating this blanket purchase agreement, we are attempting

to comply with the provisions of the audit while still continuing to

fulfill our mandate to seek out potential sources of the illnesses

being experienced by our veterans without interruption. We have

also met with OSD space management personnel to discuss bringing our current lease space under a GSA lease to better meet the

concerns of the GSA contract managers.

Mr. SHAYS. The bottom line is that the contract method is wrong,

but you are going to change it in the future?

General VESSER. We have tried to work within the system. We

have tried to point the GAO when they raised the issue with us

toward those parts of the system. We are not contract specialists.

We don’t know the philosophy of differences in contracting approach, but we are for competition and for getting the best price

on the work that is done.

Mr. SHAYS. Let me tell you where I think we are at, and then

I am going to recognize Mr. Sanders.

I am going to leave with the confidence that you all are going to

be making a heroic effort to assess where we are at and do it before

the end of the budget year, and we can have another hearing and

know where you are at.

I am going to share with you that I am uneasy with the outside

investigative effort of OSAGWI’s efforts and say to you that as we

got more into it, I felt that there could be better coordination and

sharing even though it is outside your technical definition of medical research; and I would also say to you that I think after 9 years

we have got to get to some kind of treatment and that has ultimately got to be our goal, that we want to properly diagnose and

effectively treat and fairly compensate. And so Mr. Sanders’ ultimate goal to treatment, I think, stares us in the face. With that,

Mr. Sanders, you have the floor.

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Mr. SANDERS. Thank you. I will be brief. You have been very

generous in allocating time.

I think it is very important as General Vesser said that we adequately inform veterans and keep them abreast what is happening.

I think understanding what happened on the battlefield is absolutely important. I happen to believe very strongly in epidemiologic

research and the National Cancer Registry Act, which is one of the

important epidemiological tools being used by cancer researchers.

No argument.

But after all is said and done, as the chairman just indicated,

what 100,000 veterans want to know is how are they going to get

better? That is what they want to know.

And in that respect, in all honesty I must say that given the fact that we have spent $120 million so far, we have done a rather poor

job.

It seems to me, and let me—and Dr. Feussner, jump in if you

think I am wrong. Where we are right now, I hope within a year

we will know whether or not the use of doxycycline can treat some

symptoms. We will know that and if it turns out positive, we will

have a treatment; is that correct?

Dr. FEUSSNER. Approximately a year, yes, sir.

Mr. SANDERS. What I think—and I don’t think that the U.S. Congress should be micromanaging, but I think we should be saying

right now within another year we want five different treatments

from you. We want treatments. That is what the veterans want.

Now, you have breakthroughs that are going on. I don’t know

what this squalene means, I don’t know what you can learn from

it, but I want you to translate that research into a treatment.

I don’t know what Haley’s brain scan implications are, but if it

can be translated into a treatment, do it.

Multiple chemical sensitivity, we know that there are treatments

out there. Start testing it. It is beyond comprehension that after 9

years we have not developed one treatment through the VA to treat

those people who may have been made ill as a result of exposure

to chemicals.

I don’t know the possibility. You are studying pyridostigmine bromide. That is very important, and I know that relates to a treatment. Why don’t we start. I think that I speak for veterans who

say look, we recognize you don’t have the magic bullet. But try to

do something. If it fails, I will support you in saying we tried it.

It failed; do something.

So I would hope, and we will be working together, Dr. Feussner,

you will be hearing from me. I want treatments. That is what I

want. I think I speak for the veterans’ community in stating that.

Mr. SHAYS. We are going to get to our next panel, but I am very

willing to have any of you make a closing statement.

Dr. FEUSSNER. If I may, sir, I would just like to agree with Congressman Sanders. As I think he knows, we are quite interested in

identifying treatments that are likely to benefit patients.

The only caveat, the squalene story is not associated with a

treatment option at this point, but we will keep an eye on it.

The observation of the brain is not associated with a treatment

option yet; but again we will be attentive to that, just like there

are efforts to treat other brain diseases, Alzheimer’s, et cetera. We

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will be very attentive to that. I think that the only caveat that the

Congressman agrees with, the treatment trials involve human

studies and the human studies are justly due the dual protections

under the common rule of scientific review and informed consent.

That is the only caveat. I know that Congressman Sanders concurs

with that.

Mr. SHAYS. Thank you all very much. We appreciate your patience.

We will conclude with our third panel comprised of Dr. Iris Bell,

associate professor, Program in Integrative Medicine, University of

Arizona College of Medicine; Dr. Claudia Miller, assistant professor, Environmental & Occupational Medicine, University of Texas

Health Science Center; and Dr. Mohamed Abou-Donia, professor,

Department of Pharmacology and Cancer Biology, Duke University

Medical Center; and Howard Urnovitz, scientific director, Chronic

Illness Foundation. If you will remain standing, I will swear you

in.

[Witnesses sworn.]

Mr. SHAYS. We have three witnesses, Dr. Bell, Dr. Miller and Dr.

Urnovitz. I really appreciate your patience. It is toward the end of

the day rather than the beginning of the day; but your testimony

is very important, and we are grateful that you are here.

Dr. Bell, we will start with you.

STATEMENT OF IRIS BELL, M.D., PH.D., ASSOCIATE PROFESSOR, PROGRAM IN INTEGRATIVE MEDICINE, UNIVERSITY OF

ARIZONA COLLEGE OF MEDICINE; CLAUDIA MILLER, M.D.,

M.S., ASSISTANT PROFESSOR, ENVIRONMENTAL AND OCCUPATIONAL MEDICINE, UNIVERSITY OF TEXAS HEALTH

SCIENCE CENTER; HOWARD URNOVITZ, PH.D., SCIENTIFIC

DIRECTOR, CHRONIC ILLNESS RESEARCH FOUNDATION

Dr. BELL. Thank you, Mr. Chairman. I am speaking today as

both a VA-funded researcher and as an independent researcher in

the sense that I have funding from the VA; but at this point I am

speaking primarily as an individual researcher who has been involved in multiple chemical sensitivity research for many, many

years.

As the GAO report noted, the data from several studies in Gulf

veterans with unexplained illness really converges on the likelihood

that a large number of these individuals may have conditions that

fall in the broad spectrum of chronic fatigue syndrome,

fibromyalgia and chemical sensitivity.

However, in addition to that, from the data available, there appear to be a number of Gulf veterans who are suffering from something that falls along a continuum that may not reach a level of

case definition criteria from an epidemiologic point of view. This

creates methologic issues in terms of identifying people who are

sick versus not sick but certainly does not eliminate the high likelihood that a number of people have this problem to a degree.

The trouble is that when a problem is so clinical in nature or is

polysymptomatic, as in these conditions, generally conventional

medicine has very little to offer for these difficulties. Most of these

in fact are not specifically associated in a clear linked way with the

toxicity with specific toxins in the environment, which again has

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made it difficult in terms of prior research to identify specific

causes.

Unfortunately, assuming even if the medical profession were to

accept the validity of these polysymptomatic conditions, which they

at this point frequently do not, conventional psychiatry in medicine

has very few tools to treat them. Typically, medicine labels these

individuals as having some form of, ‘‘somatoform disorder,’’ which

is basically a nonetiological label for having multiple symptoms in

multiple systems with no known treatment and no other known diagnosis that can be identified.

This has led, I believe, to the unusual emphasis on stress research specifically within the Gulf war work, but this has indicated

also that there may be more things to examine. Many Gulf veterans with these problems, such as chronic fatigue and chemical sensitivity, do have psychiatric issues as comorbidities. A definitely

large number of them have no psychiatric problems; and yet in this

area, the area of psychiatry has been emphasized to the exclusion

of other possible mechanisms.

In the civilian population, a large proportion of affected individuals have given up on what conventional medicine may have to

offer and have chosen to resort to various forms of what is called

complementary and alternative medicine. The field of environmental medicine within which multiple chemical sensitivity does

fall within the definition of the National Center for Complementary

and Alternative Medicine at NIH is an area that could be researched but in general has not been at this point. However, because of the controversy around both the illnesses and the treatments, there are significant difficulties in people having addressed

these issues up to this point.

My recommendation is that we take a patient-centered rather

than a disease-centered approach to treatment research. That involves, as Congressman Sanders indicated, focusing on what the

veterans are telling us they have tried and what they think helps

them. That is a very pragmatic approach, but it appears to be time

to do so; and it is quite possible that at this point this would be

quite an appropriate time to pursue aggressive research on chemical sensitivity and related syndromes.

In my own research I have been looking at patient-centered

mechanisms that have not been as specifically focused on specific

toxins as on vulnerable individuals. In our own work in a very

small but random sample at the Tucson VA, we found that 86 percent of ill Gulf veterans versus 30 percent of healthy Gulf veterans

and 30 percent of healthy area veterans were reporting that they

considered themselves especially sensitive to certain chemicals.

We have used this screening question in literally thousands of civilians, and we get a rate in answer to this particular screening

question of about 30 percent in the general population. And so indeed we see it in veterans who were not in the Gulf, but we see

it in a much higher rate by self-report in the ill Gulf war veterans.

At this point from the standpoint of looking at this issue, the

Gulf veterans also reported without attributing particular cause

that they had multiple chemical exposures, including oil well spills,

pesticides, diesel fuel, et cetera, that they had these exposures at

higher rates than the people who were healthy.

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They particularly focused in this situation on insect repellants

and pesticides. Conventional toxicology has no easy explanation for

a diversity of eliciting factors, or for this enhanced low dose reactivity at this point. They are pursuing certain avenues, but this has

not been overly fruitful to date. The field of pharmacology does

offer a phenomenon which has been studied extensively for other

purposes and can accommodate this diversity and enhanced reactivity. It is called neurosensitization.

Sensitization is a progressive amplification of response in the

host to repeated intermittent exposures to an initiating stimulus.

It is not seen when the exposure is continuous, which is a model

frequently used in toxicology research. Once the sensitization is initiated, reexposures to the same or other cross-sensitizing stimuli

can elicit a heightened response.

This amplification process probably reflects changes in cell functioning rather than structure and does not necessarily require the

immune system, although it can be affected by a similar process.

Our own research in this area in civilians has shown that, even

though these people are psychologically distressed, they differ in

their brain wave status even at baseline from individuals who are

depressed but do not have chemical sensitivity by self-report and

from normal people.

We have found also that when tested over repeated sessions with

extremely low level exposures, persons with chemical intolerance

exhibit sensitization to whatever they are exposed to in the session,

in brain waves, heart rate and their blood pressure. These effects

are not seen in controls of various types.

We have found also evidence for individual difference susceptibility factors in civilians that parallel those in sensitizable animals

who have been studied the most in these areas. These factors of

vulnerability include being female, having certain genetic characteristics. In our human research this has been converging on information that they may have family histories of substance abuse

even though they themselves cannot tolerate alcohol. We also see

spontaneous preference for sucrose, both in animals who are more

sensitizable and in the civilians who are reporting this problem,

and a baseline hyperreactivity to novel environments.

This kind of work has been pursued in animals and there are

animal models demonstrating sensitization to chemicals. And this

work is still ongoing, but to my knowledge it has not been directly

pursued in terms of Gulf war. Our sense is that sensitization and

cross-sensitization could help account for the fact that some veterans have different exposure histories and stress histories during

military service, but they end up with similar polysymptomatic

conditions.

The mechanism could allow us to explain that multiple interventions could in fact be helpful, coming at this problem from different

directions because by removing any eliciting stimulus of any class,

be it chemical, stress or otherwise, we might reduce the frequency

and severity of the currently sensitized symptoms, but this would

not necessarily prove a role for any specific etiologic factor.

In our VA funded study, we are testing the possibility that the

chronically ill Gulf veterans are persons who are at least now more

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sensitizable than our healthy veterans. We are using extremely low

levels of exposure that are not detectable by smell.

In our preliminary analyses of our initial data set, we have found

some evidence for sensitization looking at the heartbeat itself during repeated sessions over a period of weeks. These individuals

have been receiving, in order to do the sensitization, undetectable

levels of jet fuel JP8 versus clean compressed air. We have much

further research to do and many other analyses to do before we can

say with certainty that this finding will be validated; but we are

very encouraged that it has been there from the start of our work

when we began to look at our interim analyses.

In conclusion, the phenomenon of sensitization is well documented in basic neuroscience research. It depends on time-related

changes in functioning, not structure of nerve cells in response to

repeated intermittent stimuli and could help explain the emergence

of problems in veterans after they return from the Gulf and the difficulty in identifying particular causes because this phenomenon

has both an initiation and an elicitation phase which can be essentially separated.

The stimuli capable of initiating and eliciting sensitized responses are diverse in nature, and they range from chemicals to

stress which can cross-sensitize with each other. Some people do

sensitize more readily than others. This mechanism deserves further evaluation as a possible mechanism by which a number of

Gulf war veterans may have become ill.

Thank you.

Mr. SHAYS. Thank you, Dr. Bell.

[The prepared statement of Dr. Bell follows:]

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Mr. SHAYS. Dr. Miller.

Dr. MILLER. Thank you. There is an old parable: for want of a

nail, the horseshoe was lost; for want of a shoe, the horse was lost;

for want of a horse the rider was lost; then the battle, the war and

finally the kingdom all for the want of a nail.

This is precisely the situation we find ourselves in today. For

want of a paradigm, our veterans are lost in a sea of inconclusive

reports, redundant studies, expanding budgets and programs and

committees and cries of conspiracy all for want of a paradigm,

something to explain the relationship between the exposures they

experienced during the Gulf war and the multisystem symptoms

that now plague them.

We have veterans seeing different specialists who apply different

monikers to their symptoms. The rheumatologist sees them and diagnoses myalgias based on diffuse muscle pain; the neurologist

hears head pain and nausea and diagnoses migraine headaches.

The pulmonologist finds airway reactivity and diagnoses asthma.

The psychiatrist seeing chronic malaise diagnoses depression. The

gastroenterologist notes GI complaints and diagnoses irritable

bowel syndrome.

Most ill veterans have symptoms involving several organ systems

simultaneously. For them there is no unifying diagnosis, no known

etiology and no identified disease process. This is not the first time

doctors have found themselves baffled by wartime disease. 130

years ago during the Civil War, doctors were faced with a similarly

mysterious syndrome characterized by fever. Hundreds of thousands of soldiers died. The doctors did what good epidemiologists

do today, they classified the cases. Since the hallmark symptom

was fever, they classified the cases by fever type: remittent, intermittent, relapsing.

In doing so, they unknowingly lumped together dozens of unrelated illnesses, everything from typhus and typhoid to malaria and

tuberculosis and other diseases. Who would have dreamed it at the

time, the germ theory of disease. This war going on between invisible invaders and the body’s immune defenses with the only outward sign being literally the heat of battle.

Today, we face this same situation with Gulf war veterans; only

this time the hallmark symptom is not as simple as fever. It’s the

newly acquired intolerances these veterans have been experiencing

since the war. Like the mechanic who before the war used to bathe

in solvents and now becomes ill after one whiff of gasoline. Or the

young woman soldier who recalls how she used to be able to drink

any man in her company under the table, but since the war she

can’t take even one drink without becoming violently ill. The vast

majority of sick veterans report these newly acquired intolerances

which date from their experiences in the Persian Gulf.

During the past 7 years, I have served as the environmental

medical consultant to the Houston VA’s regional referral center.

Approximately 90 percent of the veterans interviewed described

new onset intolerances to everyday chemical exposures which set

off their symptoms; 78 percent were intolerant of fragrances, tobacco smoke, gasoline vapors and other chemical inhalants; 78 percent also described food intolerances; 66 percent reported alcohol

intolerance; 25 percent were intolerant of caffeine; and nearly 40

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percent reported adverse reactions to medications—all since the

Gulf war. These intolerances, resulting in flare-ups of symptoms,

including fatigue, headaches, GI problems, mood changes, cognitive

impairment and diffuse musculoskeletal pain are like the fevers experienced by the Civil War soldiers. They are the outward manifestation of the underlying disease process.

This is not the first time this illness pattern has appeared on the

medical landscape. Researchers have described these same new

onset intolerances and multisystem symptoms in demographically

diverse groups in more than a dozen countries—sheep dippers in

the United Kingdom exposed to organophosphate pesticides; radiography workers exposed to x-ray developing chemicals; including

glutaraldehyde in New Zealand and other countries; aerospace

workers on the West Coast of our country exposed to solvents and

plasticizers; and environmental scientists exposed to indoor air contaminants during remodeling at the EPA’s own headquarters building in Washington, DC, to name a few.

What ties all these groups together is the common experience of

an initiating toxic exposure followed by newly acquired intolerances

and multisystem symptoms. These observations provide compelling

scientific evidence for a shared underlying disease mechanism, one

involving a fundamental breakdown in natural tolerance. This twostep mechanism an initiating toxic exposure followed by newly acquired intolerances that trigger multisystem symptoms has been

referred to by the acronym TILT, or toxicant-induced loss of tolerance.

This two-step process is the key to understanding Gulf war illness. It doesn’t matter so much which exposure caused the breakdown intolerance, whether it is pesticides, smoke from oil well

fires, pyridostigmine bromide or indoor air contaminants. Those

things have long since left these veterans’ bodies. It is the aftermath of those exposures, the new onset intolerances to low-level

chemical exposures which appear to be perpetuating their symptoms. In some cases, it may be difficult to sort out what individual

intolerances or triggers may be operating because of a phenomenon

called ‘‘masking.’’ This occurs when individuals are reacting to so

many different exposures that they become a confusion of symptoms.

But the confusion clears for both the patient and the physician

when the underlying paradigm is understood, and questions that

could not be answered are now answered.

Like why some veterans became ill and others didn’t—because

individuals react differently to toxic exposures and some have no

response at all. Or why researchers have been unable to isolate a

single culprit exposure—because the answer to the question, what

caused the Gulf war illness, is more likely to be all of the above.

It explains why veterans remain sick almost a decade after the

war, long after their initiating exposures. It explains why symptoms wax and wane unpredictably—as their daily exposures are

waxing and waning. What can be done to diagnose and treat the

chemically intolerant? There is evidence that removing them from

the exposures that are affecting them now by putting them in an

environmental medical unit will cause their symptoms to subside.

The EMU is designed to help patients avoid common low-level exVerDate 11-MAY-2000 08:58 Dec 27, 2000 Jkt 000000 PO 00000 Frm 00125 Fmt 6633 Sfmt 6633 C:\DOCS\67151.TXT HGOVREF1 PsN: HGOVREF1
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posures. Previous experience shows that within days of entering a

facility of this kind, patients will arrive at a clean baseline and

their exposure-related symptoms will disappear. During the next 2

weeks, each patient is exposed to potential triggers, such as caffeine, gasoline, perfumes, various foods, medications, and tobacco

smoke, one at a time, to determine what is setting them off.

Epidemiological data and literature reviews can only go so far in

determining the nature of a new disease process. New paradigms

require new approaches and new tools. EMU studies will enable

doctors to witness this disease mechanism firsthand and understand Gulf war illness for what it is, while providing a built-in

treatment component—one that enables the veterans to understand

their disease and emerge less confused, less hopeless, and more in

control of their lives.

A validated questionnaire about chemical intolerance is available

in the medical literature, and I have enclosed it in this testimony,

which the VA and military doctors could use as a first step toward

introducing physicians and patients to this paradigm so they can

begin to see it for themselves. If we are going to help these veterans what is needed is not more epidemiologic studies and literature

reviews, but rather to use a term that Congressman Sanders has

used in the past, a Manhattan Project-style approach consisting of

EMU studies and other patient-oriented diagnostic and treatment

studies.

Mr. SHAYS. Thank you, Dr. Miller.

[The prepared statement of Dr. Miller follows:]

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Mr. SHAYS. Dr. Urnovitz.

Dr. URNOVITZ. Thank you. I am grateful to the committee for allowing me the opportunity to review the GAO report and for inviting me to present my views and recommendations on research directions for Persian Gulf war-related illnesses, or Gulf War Syndrome.

My name is Dr. Howard Urnovitz. I received my doctorate degree

in microbiology and immunology from the University of Michigan

in 1979. My entire CV is submitted with my written testimony. I

currently hold the position of scientific director of the Chronic Illness Research Foundation as well as my current position as the

chief science officer of a publicly traded biomedical company.

With respect to my views on government research programs concerning Gulf War Syndrome, I concur with the GAO report that

many of the research objectives identified by the research working

group of the Persian Gulf veterans coordinating board have not

been reached. Some of the government-funded epidemiological studies, particularly those of the Centers for Disease Control and Prevention and the University of Texas Southwestern have been very

meaningful.

Most of the government-funded research conducted thus far has

focused on trying to quantify exposures with little or no data, identifying single exposure agents as the sole causative factor, or summarizing the research of others. The identification of the range of

toxic exposures would assist greatly in determining the array of

causative factors associated with Gulf War Syndrome. Today we

are already have a great deal of information on the potential exposures during the Gulf war. Unfortunately, since a significant

amount of the data was not collected, we will never know with any

degree of certainty what the extent and combination of the exposures were in the case of each individual patient.

Further, identification of these exposures alone will not reveal

the disease mechanisms involved in the progression of these illnesses. Identifying the disease mechanism has been the focus of

our research. I recommend that Congress strongly encourage the

Department of Defense, the department of Veterans Affairs and the

department of Health and Human Services to fully acknowledge

nongovernment-funded published peer-reviewed independent research to further expand the total information base on Gulf War

Syndrome. I am concerned that we in the independent research

community do not have a structure for free dialog with government

agencies and researchers. To exclude these contributions to science

is not productive.

The GAO report recognizes medical science’s conventional approach to chronic illnesses. The paradigm continues to be a search

for a single causative agent. The weakness in this conceptual approach is that most chronic diseases are multi-factorial. The single

causative agent approach was formulated long before science recognized that the human body can sustain damage at the cellular and

molecular level from a variety of physical, chemical, and biological

insults and long before we determine the vast arrays of hazardous

materials to which these veterans were exposed. Assigning any one

entity as the causative agent will impede any progress in designing

medical control or treatment of a chronic disorder.

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I thank the subcommittee for recognizing the contributions my

colleagues and I have made to the Gulf War Syndrome medical literature. It is my hope that our unique approach to understanding

Gulf war illnesses may serve as a platform for research into other

chronic ailments. My colleagues and I approach Gulf War Syndrome like most other chronic illnesses by asking the follow question: What is common among people who suffer from chronic diseases? For brevity, I will summarize our research findings published in six peer-reviewed papers in 1999 on four different diseases. One of these papers is attached to my written testimony.

It would appear that the human body has a mechanism for confronting toxic exposures. We all know that we are given our physical characteristics from genetic material, or genes, one set of genes

received from each parent. What we learned by simultaneously

studying Gulf War Syndrome, cancer, AIDS and multiple sclerosis

is that genes have the ability to reshuffle and create new genes.

We reasoned that these new genes are used to adapt to the toxic

environment in which we live. It seems that there are confounding

events that turns this reshuffling mechanism from a normal protective process to a disease state.

One of the next phases in our research plans is to determine

what events trigger these reshuffled genes to convert from helpful

to harmful. Through a research blood test we recently developed,

we have been able to identify material in the sera of patients suffering from chronic illnesses that likely play a critical role both as

a marker of the illness and as a mechanism for the reshuffling.

This discovery of the reshuffling process resulted from the identification and analysis of a type of nucleic acid, RNA, found in the

serum or plasma of Gulf war veterans. It took us several years to

break the code on just one RNA molecule that we were able to isolate. It has been our goal to collect RNA from as many veterans

with Gulf War Syndrome and control and clone, decode and catalog

the reshuffled genes with respect to patient symptomology. This

approach should allow us to group ailments according to the pattern of each gene sequence.

The modern marvel of mapping the normal human genome is

close to completion. We plan to initiate our own program, mapping

the detours that the human genome takes with respect to toxic exposure and chronic disease. The ensuing catalog of reshuffled genes

should assist in establishing diagnostic protocols and tailoring

treatments for each patient. The single greatest obstacle to achieving this goal with respect to veterans has been the lack of sufficient

private-sector funding for research into an issue that most people

believe is the responsibility of the government.

I include supporting testimony from my colleague, Professor Luc

Montagnier, whose laboratories with 4 decades’ experience of evaluating the biomedical and medical significance of RNA, led the research effort into discovering the AIDS-associated viruses: HIV–1,

2, and group O. We jointly concur that to understand the origin of

diseases associated with RNAs in Gulf War Syndrome, a major effort must be launched on understanding a family of genes referred

to as retroelements. Retroelements make up over 6 percent of the

genes in the human body and appear to be central to the origin of

disease-associated RNA.

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I would like to state for the record that it is my professional

opinion that the clues to solving significant medical problems in

the world today, cancers, AIDS, heart and liver diseases, autoimmune and neurologic disorders, vaccine safety, chemical injuries

and military-associated ailments lie in the blood of these veterans

who suffer from Gulf War Syndrome and possibly in the blood of

their families. Once we break and catalog the code of reshuffled

RNA, we may finally have a clear direction on how to treat chronic

illnesses in general. The Gulf war veterans will become heroes

again for a second time.

I ask that the full text of my statement along with the prepared

statement from my colleague, Professor Montagnier, be submitted

for inclusion in the hearing.

[The prepared statement of Mr. Urnovitz follows:]

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Mr. SHAYS. Before I ask my questions, I want to thank Mr. Chan

for staying and hearing other witnesses and also Dr. Feussner and

Dr. Mazzuchi and Dr. Foster. It is appreciated that you listen to

the other witnesses.

I am struck by the fact that if you had testified 4 years ago, it

would almost seem like you were speaking a foreign language, and

it doesn’t seem so foreign to us today so there is some kind of

progress here.

I think the thing that I recognized, the most astounding thing

that I felt was beginning to understand why our veterans were

faced with this kind of lack of sympathy and lack of receptivity to

their illnesses. We had no doctors in VA except a few occupational

therapy-types that were thinking the way that you are thinking.

They are competent doctors, but they weren’t involved in occupational hazards.

So I guess what I would ask, it seems to me what you are suggesting is we are making some progress. You are here and there

are others who have testified before you, but that the paradigm

that we are using is still wrong.

Dr. URNOVITZ. That’s correct.

Mr. SHAYS. And all three of you have been able to make your

case, some who sit on the board.

Where do you all disagree with each other?

Dr. MILLER. Can I say maybe what the context here is?

Mr. SHAYS. Yes.

Dr. MILLER. There are some very specific mechanisms that can

relate to the continuing symptoms that the veterans are having,

and it might be on the basis of genetic changes or

neurosensitization. There are many specific mechanisms including

inflammation that people have proposed to explain some of these

ongoing health problems.

With respect to the intolerances that people have now, we don’t

understand the underlying mechanism any more than we did back

when people had the germ theory of disease. They didn’t know how

cholera, for example, operated; but they had a particular concept

which could be tested.

I think it is important to keep in mind if there were this initial

event, exposure, and people develop intolerances, we can intervene

without knowing the specific mechanisms. In fact, when people recognized if you washed your hands or wore gloves going from one

child-bearing to the next, one birth to the next, you wouldn’t transmit child bed fever; but people didn’t know about the germs that

caused child bed fever. They had this crude theory of disease, but

it allowed them to operate in a way that prevented the transmission of disease.

If we have in mind there is a toxic exposure for at least some

people, and they lose tolerance for other common exposures, what

we can do is minimize the exposures that they are having currently

and start to prevent any unnecessary exposures in future wars,

and maybe identify early some of the susceptible people that I

think both Dr. Bell and Dr. Urnovitz alluded to.

Mr. SHAYS. One of the things that I concluded over time was that

there was no incentive to get into the field that you are getting into

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for a variety of reasons. Economically there didn’t seem to be an

incentive. How did each of you get into this area?

Dr. URNOVITZ. I actually tried to tell you 4 years ago, and I ran

out of time then.

I got involved because my mom died 30 years ago of cancer, and

I have been trying to figure out why. There is no single causative

agent.

We were born in Detroit, which I love dearly. However, it was

a toxic exposure. We were exposed to many chemicals getting rid

of Japanese beetles. We were given 26 monkey viruses in vaccines.

We were living in one of the greatest economic growth centers of

the world in manufacturing. There is no single cause.

I have been trying to figure out how cancer works. I have been

trying to do that for 3 decades and the germ theory I reject for

chronic illnesses. It is great for the acute bugs; we can cure them.

We can cure them with doxycycline, no problem. We are talking

about chronic diseases. These take decades to develop.

You must reject the germ theory. Just like we had to reject the

single atomic theory and go to quantum mechanics to understand

relativity, you have to start a new paradigm.

You can’t start the Manhattan Project until some Einstein writes

some Roosevelt a letter saying we just split the atom. That letter

has never been written; that is why we don’t have the Manhattan

project for these chronic diseases. We are trying to write that letter

to you.

You asked originally what is the difference between our testimonies, nothing. There is nothing mutually exclusive here. What

Dr. Miller said, I agree completely. She describes the different

phases of these diseases. They are multiphasic as well as multifactorial. Throw out the book. Start over again and start with the

fact that we are living in a toxic environment. We are trying to

keep up with a toxic environment. We love the modern marvels of

science. I love them, faster computers. But the thing is, we are not

going to give them up. We love our modern marvels, and we are

not going to give them up. Medicine has to keep up. We have to

figure out how we can keep up with the changes in the toxic environment that we live in, and we are going to constantly add pollutants to our environment, and we are going to constantly have our

genes rearranged.

The treatments that we come up with for Gulf War Syndrome

will be used throughout all aspects of medicine. I am sending this

message out to the private sector, because that is where we get

money from. We can build products, both diagnostic and pharmaceuticals, to help us keep up with modern medicine if we all recognize as a medical and scientific community that our genes do rearrange in response to toxic exposures.

That is what Gulf War Syndrome taught us. We gave 28-yearolds the biggest whopping dose of toxic exposures I can think any

human ever got, and that is Gulf War Syndrome.

Mr. SHAYS. How did you get in this field?

Dr. MILLER. First, to amplify on one statement and that is about

the different theories of disease. The importance of rejecting what

we have in the past and what we are seeing, these characteristics

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in these individuals, does not fit the germ theory. It does not fit

the immune theory of disease, our classic theories of disease.

So just as when the germ theory came along, we need to have

a new model that does fit observations by physicians and others,

what is going on with the patients. I want to say that is absolutely

right, you have to reject what you have right now. The problem is

with epidemiology. Classically, it developed out of looking at infectious diseases and looking at patterns of illness, and it doesn’t

work as well in this situation.

The paradigm here is in-depth talking with patients, 4 to 6 hours

with a patient, trying to figure out what they are saying and they

are all reporting these intolerances. There is a thread of a hallmark symptom and you can make sense if you spend the time. But

veterans are shuttled from specialty clinic to specialty clinic, and

no one has time to put together what is really going on with them,

and it takes time to get these kinds of histories, and the VA has

not had the physicians to do that.

If I could just say how, I worked before I went to medical school

as what is called an industrial hygienist looking at people in work

places who got ill and noticed that there was a subset that continued to be sick, whether it was in a sick building or after pesticide

exposure and out of interest in that went to medical school and

trained in allergy and immunology and found that I had gone into

the wrong specialty. I don’t know what specialty this is any more

but—and this led me into research, writing the New Jersey report

on multiple chemical sensitivity and some other—many papers on

the subject, and finally the Gulf war veterans came along years

after we were seeing this in civilians and the pattern looks the

same. It looks identical.

Mr. SHAYS. With Dr. Kaiser and the VA, basically we were being

told that low exposure did not lead to injury or death and yet in

my own environment as a State legislator, I was passing laws right

and left to prevent there being exposure to low-level chemicals because we ultimately felt like it would lead to injury or death. I

spent so many years of my life trying to protect workers from a bad

environment.

Dr. MILLER. There is a reason. When you talk about low-level exposures in terms of a toxicologist’s view of it and what would affect

people that were healthy to begin with, that is one thing. When

you attack people who had been exposed and lost normal tolerance,

now they can’t tolerate—one alcoholic drink, they can’t tolerate.

They can’t tolerate medications they took for years. Remember the

guys who took decongestants many times before the Gulf war, and

now one tablet makes them feel strung out for many days. There

is a fundamental loss of tolerance, and now you have thrown into

something that is orders of magniture less tolerant than what you

started with. So when EPA talks about low levels of exposure, they

are talking in the average general population, and these people are

on a different scale.

Dr. BELL. Before I address the question of how I got into it, I

would like to amplify on some of the other comments. I believe that

part of the issue is that science in general has taken a very productive direction toward reductionism, which means finding as simple

an answer as one can control all of the variables for. This is an

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issue where we have been forced by the nature of the phenomenon

to deal with multiple variables in interaction. There are statistical

techniques for doing this and methodological approaches in science

for doing it, but it is not the prevailing way science has been done

and certainly not medical research. It is not easy to do, and it is

very expensive frequently because when there are multiple variables, you require even more subjects than you would for other

kinds of studies, and you have less absolute certainty that what

you have found is the answer because frequently it is in fact a

multifactorial answer.

This means that in terms of us all saying these various points

that factors such as nutrition, factors such as genetics and factors

such as environment all interplay and you will hear people in

science adamantly proclaiming that any one factor is a major issue

having controlled for all of these other variables, and in fact that

is valuable information. But the whole picture in terms of what

happened to the individual requires an understanding that they

can interplay and interact, and that is not something that is typically looked at in a lot of research.

In terms of my own interest, as Dr. Miller was alluding to, the

kind of things I did as a graduate student in neuroscience, I was

working with a group of patients who have narcolepsy, a sleep disorder where they fall asleep against their will at undesirable times;

and I listened to what they said. And what they told me is when

they ate certain foods, they fell asleep. And that led me to meet

with doctors who were working in food and chemical sensitivity,

and I became fascinated by its potential usefulness as an area to

study within clinical neuroscience; and I pursued it from that perspective for many years.

Mr. SHAYS. Thank you. Thank you for your patience. You have

the floor.

Mr. SANDERS. Thank you, Mr. Chairman. I just want to thank

and congratulate all three of you for the extraordinarily important

work you are doing. Some day I think you will get the recognition

that you deserve. Maybe not tomorrow, but it will come. What you

are doing is extremely important.

It seems to me—I got into this, Mr. Chairman, because a constituent of mine in Montpelier, VT, was made ill by exposure to a

coffin, and her children were made ill. I didn’t believe her, and we

investigated it and so forth and so on, and I think the coffin industry has perhaps changed how they manufacture the product.

I have met with hundreds of Gulf war veterans in the State of

Vermont who, as I said before, cannot tolerate being around perfume. Mechanics, just as you described, Dr. Miller, used to work as

mechanics, they no longer can do their job. They suffer short-term

memory loss, nausea, et cetera.

Let me—and I happen to accept the paradigm that you are

throwing out. We are living in an increasingly toxic environment,

and it is hard not to believe that all of us have suffered as a result

of that and those folks over in the Gulf suffered even more, and

I want to underline the statement that all of you made that the research taking place on Gulf war illness will have an enormous impact on the general society as well.

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I remember in my office there was a woman who actually was

a nurse. She was visiting a patient. She went into the bathroom

and the woman had used heavy duty detergents, and she was ill

as a result. I have heard this a dozen different times, and I cannot

believe but that these anecdotes are true.

Mr. Chairman, you will remember the major from Connecticut,

the pilot, who became ill after jogging at a military base after they

had sprayed with some pesticide.

Dr. URNOVITZ. Dr. Donnelly came down with Lou Gehrig’s disease.

Mr. SANDERS. His feeling is that he was hit right after they had

sprayed. That is a coincidence, perhaps; but I have heard too many

of these stories.

Let me ask some specific questions, if I might. Before I do, let

me tell you a story. The story was that I took one researcher, one

gentleman whose views are not different from yours because I felt

so strongly about this about 5 or 6 years ago, I took him up to

Jesse Brown, who was then head of the VA. He made his case and

Brown was interested. I urged him to submit a grant for funding,

and he said they will never fund me. I said please do it. He did

it. And not only was he rejected, he got a letter back which he sent

to me which basically said are you crazy. You are a quack and a

fraud. You don’t have any peer reviews, and they insulted him. Not

a rejection, but an insult.

It seems to me that one of the problems is that people are living

in different paradigms. You can have a scientist coming here and

people saying you are crazy; we don’t accept what you are doing.

In fact, many of the definitions that you are using are not accepted

by large numbers of physicians and scientists in this country. We

are living in two different worlds, and I think honest people are rejecting you because they think you are crazy.

I think our challenge is how do we introduce in the Congress an

acceptance or at least a willingness to fund and take seriously this

research. Let me start off with a question to all three of you—and

I know the answer will be different—but basically what kind of response have you gotten from the government in terms of requests

for funding the research that you all are doing?

Dr. URNOVITZ. Congressman Sanders, I only play in the sandbox

with people that like me. I don’t bother going to places that don’t

understand the theory. We have gone to the private sector for funding. I can’t tell you the great honor I have by having Dr.

Montagnier submit a written testimony, knowing the ramifications.

This is probably one of the greater scientists in the world today.

I think that we should recognize an important factor of how discovery is made in the world. I have thought about this for 3 decades.

Discovery is made in small groups of people, 5, 10 people just

passionate, living, breathing new ideas. I come from the San Francisco Bay area where the standard issue is a Diet Coke, cheeseburger and working at your computer for 3 days in a row; and

those are the kinds of people who make discoveries.

I just don’t know what the wisdom is in asking agencies that collect data, regulate data and disseminate information, to do discovery and that is Health and Human Services and they do the first

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part very well. I don’t know if it is really proper for us to do discovery and legislate to make discoveries. Maybe if we thought about

it from the terms of who is successful and gets up in Sweden and

gets these little Nobel Prizes, it is people in small discovery groups

and academia, private research, occasionally a federally funded

agency; but it is the small groups.

And I ask Congress to think about maybe the resource management is where we need to think about this. How can you create an

environment for discovery that we then take that information and

the CDC has to verify it and the FDA has to regulate and the NIH

has to vet it.

I think discovery should be made in small groups and we should

find some way to do that and maybe we should take it out of the

executive branch and put it in Congress so we separate that power

and balance it a little bit more. That’s the short answer.

Mr. SANDERS. Have you particularly gone to the government for

funding?

Dr. URNOVITZ. I have not because it just doesn’t make sense to

me to think outside the box and then ask the box to fund it. So

I’ve gone to the private sector it’s just an observation of a few

years.

Mr. SANDERS. Basically you’ve given up, and you don’t think—— Dr. URNOVITZ. I never started. I go where the money goes. The

money is in biotechnology. The money is in venture capitals. And

venture capitalists have a long view that they’ll wait 10 years for

a product. I’ve successfully taken three products to the FDA. A

urine test for AIDS which is exciting. It’s an epidemiologic tool. It’s

unfortunate the People’s Republic of China will adopt it first as

their mainstream AIDS test because—well, that’s another hearing.

Let’s just talk about the fact that the—we were proud we have our

co-author Jim Fuite, whom the committee knows very well has

handed out our papers to everybody. We know that they’re there.

We’re just waiting every day with bated breath to hear how we can

work with the VA and DOD to introduce these tests.

You know, what’s going to happen—may I predict on the record

under oath what’s going to happen with your mycoplasma study?

I don’t need data to tell me how things are going to happen. You’re

going to find out it’s worse than you thought because some veterans are going to do very well on this doxycycline program but it

may be the fact is we know that the doxycycline also inhibits RNA

formation.

What’s going to happen is a year from now you’re going to sit

here going well why are only 25 percent of the people responding?

Are they the only ones who have mycoplasma. I hope I put a little

seed in your brain under oath that there are other ways that

doxycycline works.

So I ask that you look at the bigger picture here and that we

take control of it. The problem is I have no way of getting that dialog except every 4 years sitting here and telling you my thoughts

on things of how to tell the Federal Government about other research programs that are out there, a vast array of literature we’re

not quoting at all. So there are two different worlds. There is the

greatest physicians in the world and they are probably in this

country and they’re doing medicine and health care better than

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anywhere else in the world, but I never expected them to read the

literature and do the discovery work. That’s what I do. How do I

get my work into their hands. There’s only one way I know to do

that and that’s put it in the peer review journals.

Mr. SANDERS. Thank you.

Dr. MILLER. The kind of research we talked about with using an

environmental medical unit doesn’t have the same commercial potential. So going to a private donor for this is virtually impossible.

So we’ve turned to various Federal agencies. I’ve testified to Congress not 4 years ago but probably 7 or 8 years ago going forward.

I think I testified to different groups including the Presidential

committee, IOM, CDC, all kinds of groups 10 times in the last 8

years.

And it’s been on the same thing, just looking what are the observations in these veterans, look at the common thread, the new

onset of intolerances is an important clue just as fever is an important clue to infectious diseases, let’s pursue the clue. But it doesn’t

go any further than that. In fact, Congress not only has heard

about this but they actually authorized funding for an environmental medical unit in 1993.

And then it went through a series of a progression. And in the

long run the funds were diverted elsewhere. And I know Congressman Sanders has done some things even more recently, and he can

describe those better than I in terms of trying to get agencies perhaps to work together to find funding for this kind of treatment.

And it’s actually dual-research, treatment, and diagnosis—three

things in one, in trying to sort out what is getting on with the Gulf

war veterans.

There was a time when some of the Federal agencies like NIEHS

had an interest in supporting research but there was no facility

and they couldn’t fund a facility. And so there was this effort, initial effort to get the funding just for the facility. But as you know,

there isn’t an environmental medical unit yet. We’ve submitted, I

think, three or four times through VA and DOD, and the kinds of

reviews that you get back are confused.

People don’t understand it. They are operating out of old paradigms, and they will say this is still controversial. That’s the purpose of the study. Yes, it’s controversial. We have to study to settle

the controversy because it’s one that is costing not only veterans

but civilians huge sums of money. And they’ll say it’s too costly.

And of course when I found out how much money has been spent

on research in reviewing literature, I’m very sad to hear that this

is not worthy of funding.

I think it’s going to take this kind of Manhattan-style project to

make this area happen, and I’m also worried about playing in the

sandbox with people that don’t like me, that it’s very difficult having worked closely with a number of Federal agencies on this issue

trying to get them to use questionnaires and so on. It has not happened yet after this long a period of time. And I don’t see the willingness yet to have it transpire, and I don’t see a home for this

right now. I wish I did.

Dr. BELL. I have tried for many years to be funded through Federal agencies. I started with NIH and so on. When the Office of Alternative Medicine was originally set up, I was very enthusiastic

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and thought that this would be a particular opportunity; and when

I spoke with them at that time early in their existence, they basically said this isn’t controversial enough. And they discouraged me

from applying because I wasn’t studying some of the even more

controversial areas within the area of a complementary and alternative medicine. I don’t know where they would stand at this point.

I have not made any further attempts to apply through that agency.

Generally the reviews that come back are ‘‘I don’t like this area.

I don’t like multiple chemical sensitivity.’’ Frequently I do not get

thoughtful scientific critiques of the actual work. That’s what happens when I get rejected.

I have to say that after several attempts of being funded by VA,

we were—we did attempt to be funded for an environmental hazard center that had a focus on chemical sensitivity; and we were

not funded. It was the time when the VA was very much emphasizing or at least the overall research effort was emphasizing epidemiology, and that was not our strength. Our strength was in the

chemical sensitivity question.

I applied twice for the funding that I currently have through a

merit review at the VA and got very favorable reviews both times

and eventually did get the funding. I have applied to the DOD because I feel that my EEG work while not specific and not as elegant as some of the work with functional MRI and so on, would

allow us to find some biomarker that’s very inexpensive and noninvasive to identify people who might be at risk for chemical sensitivity. This might be a way of identifying personnel before they

are put in harm’s way. That was favorably reviewed but not funded.

And one of the issues often is any of this is my reading of the

way the reviews go at this point in time. This is an interesting

area. They’re beginning to take us a little more seriously scientifically, but it’s not a priority topic to them because there are so

many other areas that they feel are stronger scientifically. And so

as the way the field is going, they don’t feel that they want to invest the limited resources that are available in that particular direction.

Mr. SANDERS. My last question, Mr. Chairman. As you heard

from previous panels, I’ve been concerned that we have not developed treatment protocols, and that’s what the veterans want. If you

had the money and the resources, what treatments—could you develop treatments that actually might improve life for veterans who

are ill right now? Dr. Miller, why don’t you start on that.

Dr. MILLER. The approach would be straightforward. It would be

using a controlled environment to take patients, have them go into

this controlled hospital environment, spend the first week getting

to baseline, a clean baseline. This is not—I want to draw a bright

line here between an environmental medical unit and exposure

chamber. This is not a chamber like they have in North Carolina

or at Robert Wood Johnson. Those are strictly for maybe a few

hours exposing people to a substance.

I’m talking about an inpatient hospital facility sort of a treatment progression. Patients will stay in there for about 3 weeks, the

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first week getting to clean baseline, the next couple of weeks testing them to single foods and common low level chemical exposures.

Mr. SHAYS. Would you define clean baseline?

Dr. MILLER. Clean baseline means you’ve gotten them away from

all the usual low level fragrances, disinfectants, other things that

might be present in the air.

Mr. SHAYS. It takes a week to go through their system?

Dr. MILLER. That’s right. It takes about a week. This is by reports by many, many physicians now that they’ll get to a clean

baseline after about a week. So that any exposure related symptoms from volatile organic chemicals for example would decrease at

that point to the point where you get them so they’re feeling better,

and this is what patients report and then you can challenge.

Mr. SHAYS. Your second week is?

Dr. MILLER. The second and third weeks would be reintroducing

foods and then very judicious low-level exposures.

Mr. SANDERS. What we would have learned about that is to say

to that patient you better stay away from A, B, and C.

Dr. MILLER. That’s right. They would have identified their specific triggers and the information we have now is the people that

avoid exposures that set off their symptoms gradually regain tolerance, and then they can—— Mr. SANDERS. Do you have the concern that there may be tens

of thousands of veterans who every day are sticking their heads

into things that are simply making their illness recur?

Dr. MILLER. This is what the veterans tell me. Many of them

have gone off—tried to get away from these things, but it’s been

difficult. I had a call only the week before I came to testify from

a mother whose son was at the San Antonio VA and he’s extremely

ill, multiple, multiple diagnoses; and she was begging to get into

the environmental medical unit. I had to tell her there is no environmental medical unit right now. There just isn’t one. So veterans

and their families have heard about this idea. They recognize these

intolerances in themselves; and yet they have no recourse, nowhere

to go.

Mr. SANDERS. You’re telling us that you have a treatment that

you think certainly deserves to be reviewed and you think could be

successful?

Dr. MILLER. That’s correct. It would give you insight not only to

the underlying mechanisms but it would provide treatment and diagnosis.

Mr. SANDERS. To the best of our knowledge that is not being

done by the government right now?

Dr. MILLER. There is no place in the government or any research

center doing this work.

Mr. SANDERS. Dr. Urnovitz and Dr. Bell.

Dr. URNOVITZ. This is what I’m doing from the funding source

we’re raising right now. It’s a parallel track. What we’re going to

do—you’ve alluded to it. The AIDS deaths have dropped. We’re all

very excited about it. It’s been a very, very hard road to go and

we’re excited about it but let’s look at how that worked. It worked

because of the fact that we had drugs that could knock out the

virus in tissue culture, what’s called AZT. Didn’t work. The AIDS

deaths weren’t dropping.

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What was the single event that got the AIDS deaths to drop?

They had a marker to shoot for. Remember I said outside the box,

this is out of the box thinking that some very clever physicians did

about 10 years ago by having a marker called the viral load test

which by the way measures RNA in the blood except this RNA is

the virus HIV–1.

All of a sudden they realized that AZT alone in mono therapy

isn’t bringing the virus load down. That’s when they said maybe if

we combine a bunch of therapies together, throw in some protease

inhibitors, guess what happened. The viral load went undetectable.

Guess what one of the by-products of that was. The AIDS deaths

dropped.

In other words, you’ve got to find a viable marker. The squalene

antibody is solid work. Professor Bob Garry, I know him personally.

He’s a world class scientist. We talked privately about this. This

is an antibody that may also be an autoimmune antibody. It’s a

marker. It’s not going to be the cause of Gulf War Syndrome. It is

a marker and should be put into the panel of things that we test

for to see if it includes or not includes certain patterns.

You need a biomarker first. Before you go out and you start

treating Gulf war vets, you’re going to need a biomarker. I can’t

tell you at this point whether this RNA in the blood is the biomarker. We’re going to proceed in that way.

I will tell you we have submitted a paper in multiple myeloma,

a cancer, based on what we found in Gulf War Syndrome. Out of

30, 20 who have active disease have the marker, and 1 out of 30

who are in remission do not have the marker. This doctor then

started to prescribe a drug called Biaxin, a different type of antibiotic and those people that responded lost the marker in their

blood. Those who did not—— Mr. SANDERS. What you’re saying when you have a marker you

know what you’re shooting for.

Dr. URNOVITZ. When you have a marker, you know what to shoot

for. Right now we’re flying a plane with no windows on it. We have

no idea where we’re going and all roads get us there to reiterate

what Congressman Shays said. You have a marker you know now

how to tailor the treatment, and it’s not going to be the same. My

recommendation is—well, let me tell you what I’m doing and then

if you wish to work with us, we’d be happy to do so.

We’re going to use combination therapies to knock the RNA expression out. We’re going to use things that are antibiotics which,

by the way, evolved or co-evolved with RNA. We’re going to use

those. We’re going to use things that induce things called

interferons in the cell. We’re going to add interferons, and we’re

going to physically remove the RNA from the body. We’re looking

at combination therapies right now to remove this marker.

I personally know that things like doxycycline in some cases was

a miracle. Some people are alive and working and paying taxes

today because of that. Lots of people are not. So what does that

mean? It means that this individual responded to the therapy.

That’s all it means.

Why? That’s where we need to get at the root of this. It will require what we learned in the AIDS epidemic which by the way is

exciting but it’s not done. No one is cured. The reason why is we’ve

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got to get rid of the other RNA in the blood of people with AIDS.

That’s what we found and will be publishing this summer. We need

to take an approach that gets rid of all of these markers to get people back on the health track so they can start living their lives all

over again. We need to find those markers.

Mr. SANDERS. Are you optimistic that some day we will?

Dr. URNOVITZ. It will happen.

Mr. SANDERS. Dr. Miller.

Dr. BELL. I would agree with what the other two speakers have

said in general. However, one can also take the point of view as

one would in complementary and alternative medicine that indeed

the patient’s vulnerability is what has to be focused on.

One can take a very innovative approach, such as Dr. Urnovitz

has done, but we can also be concerned that when we intervene in

any particular mechanism, that we may imbalance other mechanisms. There are long-standing systems of alternative medicine

that are available starting with the work that’s been done more recently in environmental medicine.

Again, the controversial work that’s available, it provides a foundation for giving the patient a way to begin rebuilding their health.

In reality, in clinical practice when you work with people over

many years, you find they need more than avoidance. They have

to start with avoidance. The patients will identify that as the central thing that helps them.

However, as I said in terms of the multiple vulnerabilities, frequently they go after other things in alternative medicine to the extent they can tolerate them. And that’s one of the advantages of

the avoidance technique, that gradually over time there’s a certain

amount of ability to regain the ability to tolerate things because

these are individuals where even if they’re found, for example, to

have a nutritional deficiency, they can’t tolerate the vitamins no

matter how cleanly prepared they are and how few contaminants

and other problems or source problems they might have.

But eventually it’s a sequential treatment process and so what

one starts with is the foundation and then one builds from there.

When they get the nutrition, when they get some of these other

kinds of interventions, then they begin to again handle more and

more things. At that point I’ve also—in the early stages of treatment, I’ve also referred patients successfully for treatment such as

acupuncture which can be used without the use of any chemicals

and so on and which is frequently capable of being titrated to the

sensitivity of the patient.

These kinds of approaches are in themselves controversial. I

haven’t heard of them necessarily being studied in Gulf war, but

I wouldn’t be surprised if we had many roads to the same answers

and there would be ways of strengthening the individual.

Dr. MILLER. I just want to point to Allison Johnson’s book that

was handed out earlier that she surveyed and other people have

surveyed many chemically intolerant patients and as Dr. Bell mentioned, sort of the fundamental, the basis of their improvement

starts with avoiding things that set off symptoms—chemicals,

foods, medications, and so on and hopefully they get to a point

where they can regain some tolerance and try other things.

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I also want to say in terms of biomarkers, biomarkers are very

important. We don’t have them yet. We don’t know how many

years right now they are away. I hope it’s next month, frankly, that

we have biomarkers. But when we don’t have biomarkers, we still

have the ability to put people in a controlled environmental, get

them to a clean baseline, challenge them in a blind way to see if

symptoms recur.

It’s just like again with the germ theory, at first we could do prevention and had not identified the first germ, the first microorganism. Cholera was being treated in London by shutting off certain

water sources that were contaminated, 30 years before Koch discovered the bacterium that causes cholera.

Mr. SANDERS. I would just conclude, Mr. Chairman. I have to run

upstairs. Once again, I feel refreshed having listened to this testimony. And I think we should be embarrassed, frankly, that after

the expenditure of over $120 million, that we are not doing more

to support this entire line of research which I think is breathtaking

and just enormously important for not only Gulf war veterans but

for the American people in general. And I just would hope that

we’re going to work together to support folks like this and just

thank you again very much for your testimony.

Mr. SHAYS. Thank you. I concur with his remarks. I think it’s

been a fascinating three panels and with the three of you. And

thank you very much. I have a feeling though, it won’t be another

4 years before we meet again. Thank you. This hearing is adjourned.

[Whereupon, at 2:40 p.m., the subcommittee was adjourned.]

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