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[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]

           GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON NATIONAL SECURITY,
                  VETERANS AFFAIRS, AND INTERNATIONAL
                               RELATIONS

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 27, 2000

                               __________

                           Serial No. 106-270

                               __________

       Printed for the use of the Committee on Government Reform

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

                               __________

                   U.S. GOVERNMENT PRINTING OFFICE
74-864                     WASHINGTON : 2001

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                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH-HAGE, Idaho              (Independent)
DAVID VITTER, Louisiana

                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                     James C. Wilson, Chief Counsel
                        Robert A. Briggs, Clerk
                 Phil Schiliro, Minority Staff Director
                                 ------                                

Subcommittee on National Security, Veterans Affairs, and International 
                               Relations

                CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida         TOM LANTOS, California
JOHN M. McHUGH, New York             ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida                JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana           THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South     EDOLPHUS TOWNS, New York
    Carolina                         BERNARD SANDERS, Vermont 
LEE TERRY, Nebraska                      (Independent)
JUDY BIGGERT, Illinois               JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH-HAGE, Idaho

                               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

                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on September 27, 2000...............................     1
Statement of:
    Feussner, Dr. John, Chief Research and Development Officer, 
      Department of Veterans Affairs, accompanied by Mark Brown, 
      Ph.D., Director, Environmental Agents Service, Department 
      of Veterans Affairs........................................    49
    Sox, Harold, M.D., professor and chair, Department of 
      Medicine, Dartmouth-Hitchcock Medical Center, accompanied 
      by Samuel Potolicchio, M.D., professor, Department of 
      Neurology, the George Washington University Medical Center.    27
Letters, statements, etc., submitted for the record by:
    Feussner, Dr. John, Chief Research and Development Officer, 
      Department of Veterans Affairs:
        Followup questions and answers...........................    75
        Prepared statement of....................................    52
    Metcalf, Hon. Jack, a Representative in Congress from the 
      State of Washington, prepared statement of.................     4
    Sanders, Hon. Bernard, a Representative in Congress from the 
      State of Vermont, prepared statement of....................    24
    Sox, Harold, M.D., professor and chair, Department of 
      Medicine, Dartmouth-Hitchcock Medical Center, prepared 
      statement of...............................................    31

 
           GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES

                              ----------                              

                     WEDNESDAY, SEPTEMBER 27, 2000

                  House of Representatives,
       Subcommittee on National Security, Veterans 
              Affairs, and International Relations,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m., in 
room 2247, Rayburn House Office Building, Hon. Christopher 
Shays (chairman of the subcommittee) presiding.
    Present: Representatives Shays, Sanders, and Schakowsky.
    Also present: Representative Metcalf.
    Staff present: Lawrence J. Halloran, staff director and 
counsel; J. Vincent Chase, chief investigator; R. Nicholas 
Palarino, senior policy advisor; Robert Newman and Kristine 
McElroy, professional staff members; Alex Moore, fellow; Jason 
M. Chung, clerk; David Rapallo, minority counsel; and Earley 
Green, minority assistant clerk.
    Mr. Shays. I'd like to call this hearing to order, this 
hearing of the Subcommittee on National Security, Veterans 
Affairs, and International Relations of the Government Reform 
Committee, which is conducting a hearing entitled, ``Gulf War 
Veterans Linking Exposures to Illnesses.''
    Doubts remain, and may always remain, about the role of 
battlefield toxins and medicines in causing Gulf war veterans' 
illnesses. Today, we continue our oversight of the statutory 
process established to resolve those doubts in favor of sick 
veterans seeking proper diagnosis, effective treatment and fair 
compensation for their war-related injuries.
    Embodying a recommendation made by this subcommittee, the 
Gulf War Veterans Act of 1998 directs the Department of 
Veterans Affairs [VA], not to wait for scientific certainty, 
but to look for any plausible association between presumed 
exposures and subsequent ill health. If credible evidence for 
the association is equal to or outweighs the credible evidence 
against, the VA Secretary is authorized to presume the illness 
is service related for purposes of health care eligibility and 
compensation determinations.
    The National Academy of Sciences' Institute of Medicine 
[IOM], recently completed a study of peer-reviewed research on 
four of the agents of concern to Gulf war veterans: Sarin, 
pyridostigmine bromide [PB], depleted uranium [DU], and 
vaccines against anthrax and botulinum toxin. The IOM report 
now under review by the VA suggests the difficulty and the 
urgency of linking presumed toxic exposures with chronic health 
effects.
    Not surprisingly, medical literature to date contains 
little evidence to support any association between low doses of 
the agents in question and long term illnesses.
    Those findings say far more about the stunted scope of 
scientific inquiry over the past decade than about the likely 
weight of scientific evidence. The significance of the report 
lies in the fact the IOM found virtually no evidence that would 
rebut a presumption of a causal association between these 
agents and many of the maladies suffered by Gulf war veterans.
    As the IOM panel noted, the task of establishing plausible 
dose-response relationships was made more difficult by the lack 
of hard data on wartime exposures and by the lack of adequate 
military medical records.
    Based primarily on studies following the Tokyo subway 
attack, the committee did conclude sarin exposures inducing 
immediate, if moderate, symptoms could also cause longer term 
health effects similar to those observed in many Gulf war 
veterans. But veterans' illnesses could not be more firmly 
associated with sarin because battlefield medical surveillance 
did not distinguish between the acute symptoms of mild sarin 
toxicity and the myriad of other environmental and stress-
related health effects suffered by U.S. service personnel.
    The IOM committee was also hampered by lack of access to 
classified information held by the Department of Defense [DOD], 
on toxic agents in the war theater. In the course of our 
oversight, many have called for full access to DOD records on 
chemical and biological detections. Given the statutory mandate 
that VA search broadly for information on toxic exposures, the 
VA should join us in pressing for declassification of all 
records relevant to the health of Gulf war veterans.
    Doubts remain. But our obligation to act now on behalf of 
those willing to make a certain and timeless sacrifice can be 
subject to no doubt, no delay. They earned the benefit of any 
doubt about the extent of our debt to them. They should not be 
asked to wait for certainty that might come too late, if at 
all.
    Mr. Metcalf is joining us from the great State of 
Washington, and I'd welcome any comment you'd like to make.
    Mr. Metcalf. Thank you very much. I do have a statement. 
Mr. Chairman, I want to thank you for the opportunity to once 
again be a small part of your courageous effort to answer 
questions regarding Gulf war illnesses and the vaccines used by 
our military personnel. Your determination to move forward and 
find answers has provided vital leadership for Congress on this 
critically important issue.
    Indeed, we have an obligation to pursue the truth, wherever 
it may lead us. To do less would be to act dishonorably toward 
the dedicated men and women who stand between us and a still 
dangerous world.
    For that reason, I have issued a report I would like to 
present to you and to the IOM committee culminating a 3-year 
investigation into the conduct of the Department of Defense 
with regard to the possibility that squalene, a substance in 
vaccine adjuvant formulations not approved by the FDA, was used 
in inoculations given to Gulf war era service personnel. 
According to the GAO, General Accounting Office, scientists 
have expressed safety concerns regarding the use of novel 
adjuvant formulations in vaccines, including squalene.
    The report reveals that the FDA has found trace amounts of 
squalene in the anthrax vaccine. The amounts recorded are 
enough to boost immune response, according to immunology 
professor, Dr. Dorothy Lewis of Baylor University. Therefore, 
my report concludes that, Mr. Chairman, you are absolutely 
correct in demanding an immediate halt to the current Anthrax 
Vaccination Immunization Program.
    My report further states that an aggressive investigation 
must be undertaken to determine the source of the squalene and 
the potential health consequences to those who have been 
vaccinated, both during and after the Gulf war.
    The report also documents at length DOD, Department of 
Defense, stonewalling attempts to resolve the squalene issue, 
which GAO investigators characterized as a pattern of 
deception. I think that's very significant. The GAO stated that 
the Department of Defense denied, denied conducting extensive 
squalene testing before the Gulf war, then admitted it after 
being confronted with the public record.
    The DOD denied conducting extensive squalene testing before 
the Gulf war and then admitted to it after being confronted 
with the public record. I think that's significant. The GAO 
revealed that Department of Defense officials deliberating 
deployment of the anthrax vaccine expressed a ``willingness to 
jump out and use everything,'' that's a quote, in discussing 
the experimental vaccines containing adjuvants not approved by 
the FDA.
    GAO also found Peter Collis, Department of Defense 
official, who headed vaccine efforts, refused to cooperate with 
them. The report states that the Department of Defense has 
refused to act in good faith upon the GAO recommendations to 
replicate the findings of a test developed by renowned 
virologist, Dr. Robert Garry of Tulane University, although 
Department of Defense admitted that they could easily do so. 
The work of the Tulane researchers has been peer reviewed in a 
scientific publication of high standing.
    Finally, my report states that Congress should take 
immediate action to review the findings of the GAO and the 
Armed Services Epidemiological Board and provide independent 
oversight for the immediate implementation of their 
recommendations. The board called upon the DOD to engage in 
close cooperation with the Tulane researchers.
    Congress must get to the bottom of the labyrinth that has 
become known as Gulf war illnesses. Mr. Chairman, you have been 
in the forefront of this effort. As I am about to leave the 
Congress, I just want to once again commend you for your 
courage in this leadership role. Please stay the course. 
Veterans, active service members and their families deployed 
around the world are counting on you.
    Thank you very much.
    [The prepared statement of Hon. Jack Metcalf follows:]

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    Mr. Shays. Thank you, Mr. Metcalf, and I was just going to 
comment that you will be very missed. We have appreciated your 
interest not only in this issue but in so many others, and I 
was sorry when you announced you weren't running again and I 
just know whoever gets to return next year, they will certainly 
miss you, and I will just say whatever this committee has done 
on this issue, and they have done, has been shared equally with 
Mr. Sanders on this issue. He has been truly at the forefront, 
and I welcome him here and I welcome any statement he'd like to 
make.
    Mr. Sanders. Thank you very much. And as Jack Metcalf just 
said, you have played an outstanding role in keeping this issue 
alive on behalf of tens and tens of thousands of men and women 
who are suffering from Gulf war illness, and it has been a 
pleasure to work with you and I applaud you for your 
leadership.
    Over the past 5 years you have worked diligently to hold 
members of the military establishment accountable for their 
actions and, most importantly, their inaction. You and I and 
others have worked closely to try to get the Congress and the 
administration to fund serious research into potential causes 
and cures for the diseases known as Gulf war illness and to 
push for compensation for those veterans who have contracted 
these diseases. I am sad to say that despite our efforts we 
have up to this date only had limited success. The findings of 
the IOM study that we are examining today only serves to remind 
us how far we have yet to go on this issue.
    Some good news is that Chairman Shays and I worked very 
hard this year to secure 1.6 million in the defense 
appropriations bill for research into whether Gulf war 
illnesses is the result of low level multiple toxin exposures 
which manifests itself as a condition known as multiple 
chemical sensitivity. We will be playing an active role in 
making sure that this money goes for serious research into this 
area.
    I notice that Dr. John Feussner is here and he'll be 
speaking later, and I look forward to his discussion, the 
clinical study done with doxycycline and what the status is of 
that report, which is also an area we've worked on.
    Let me begin by stating how I approach the issue of Gulf 
war illness, and that is when this country asks men and women 
to serve in the Armed Forces and those men and women are 
injured, whether in body or in mind or in spirit, the Federal 
Government has an absolute, unquestionable obligation to make 
those people whole to the maximum medical and scientific extent 
possible. In addition, the Federal Government has an obligation 
to compensate those veterans fairly, not to argue with them 
every single day, but to give them the benefit of the doubt, 
and when it is clear that veterans have been injured during 
their service, we should not deny them compensation just 
because we cannot say which particular exposure or combination 
of exposures caused that injury. In my view, on all counts the 
Federal Government has failed and failed miserably with respect 
to Gulf war illness.
    You know, one of the unanswered questions of our time, and 
I certainly don't have the answer, Mr. Chairman, is that this 
turning one's back on veterans has gone on in this country for 
so very long. It started at the very least in World War II when 
for years we ignored the impact of radiation illness. It went 
to Vietnam, where veterans organizations had to struggle for 
years and years to get the VA to acknowledge the horrendous 
impact that Agent Orange had, and we're still struggling with 
that fight today, and look what we have to do with Gulf war 
illness. I don't understand it. I really do not understand why 
when we ask men and women to put their lives on the line, when 
they come home we fight them. We become the enemy that they--
similar to the enemy they fought in battle.
    Over 100,000 veterans have reported suffering from some 
combination of symptoms associated with the syndrome we call 
Gulf war illness. Certainly it is important that we exhaust 
every possible research avenue to find the cause and the cure 
but we should not hold up compensation of Persian Gulf war 
veterans who have very real illnesses, because we have failed 
either through incompetence, insufficient resources or lack of 
dedication, or just lack of scientific knowledge, to identify 
the specific toxic compound or compounds that are responsible. 
This is particularly true because the Pentagon's negligence in 
keeping adequate records of exposures in the Gulf theater may 
prevent us from ever finding a definitive answer.
    As for the IOM study that we are reviewing today, I say 
with all due respect to the IOM that this study only confirms 
what most of us already knew. There is a dearth of research in 
peer-reviewed scientific literature on the long-term health 
effects of exposure to various toxins that our soldiers 
encountered in the Gulf war theater.
    Let me just add something to that. When I used to hear the 
word ``peer-reviewed'' I thought that was the right thing. But 
since I have been involved in this issue, you know when I hear 
``peer-reviewed'' what it often connotes to me is the people 
who do not know much about an issue who cannot come up with an 
answer in an issue will always tell us what other people are 
doing, cutting edge research, that it's not peer reviewed and 
the peer-reviewed research that we hear tells us we don't know 
anything, that's the good research, we don't know anything when 
people are doing breakthroughs, who are doing cutting edge 
stuff, is not peer reviewed, and that's a problem I have seen 
for many years in this issue, in this area.
    As the IOM reported, the peer-reviewed literature contains 
inadequate or insufficient information to determine whether 
there is an association between Gulf war illness and exposure 
to depleted uranium, between Gulf war illness and 
pyridostigmine bromide, between Gulf war illness and low level 
exposure to sarin gas, between Gulf war illness and anthrax 
vaccine or other vaccines or combinations of vaccines. These 
findings do not come as a shock to me or anyone else who has 
followed this issue.
    The reason we do not have this research is that the Federal 
Government and, in particular, the Pentagon has failed to keep 
faith with the men and women who served in the Gulf. They have 
dragged their feet and, were it not for the efforts of people 
like Chairman Shays and the Gulf war veterans themselves, the 
military long ago would have forgotten about this issue. There 
would not have been--there would not be a Gulf war problem 
today.
    I do want to commend the IOM on their research 
recommendations. These track the approach Chairman Shays and I 
have been advocating. Instead of looking for one single toxin 
as the cause of Gulf war illness, we need to investigate the 
impact of the multiple, often low level exposures that Gulf war 
veterans experienced. As the IOM report states, this, ``may 
provide a more realistic approach toward understanding 
veterans' health issues and may provide insights for preventing 
illnesses in future deployments.''
    Finally, Mr. Chairman, I want to express my concern that 
there is still not the will within the military to get to the 
bottom of this very real health emergency. In my view, it is 
time for the military to make available to properly cleared 
independent researchers--you know, if you go back to somebody 
who year after year tells you, gee, I don't understand the 
problem, gee, I don't have a cure for the problem, what do you 
do? You go to a doctor that says, well, I'm not 100 percent 
sure that I have it, but this is a breakthrough, we're working 
on this. And the good news is you and I know, because you have 
brought every serious researcher in the United States to this 
committee, there are some good people out there doing some 
breakthrough research. Let's put more emphasis on some of those 
people.
    So I want to just applaud you, Mr. Chairman, and commend 
the veterans organizations for their persistence, and you and I 
will continue to work on this issue, I'm sure.
    Jack, thank you very much for your work over the years.
    [The prepared statement of Hon. Bernard Sanders follows:]

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    Mr. Shays. Thank you, Mr. Sanders. Just before going on 
with our panel, I ask unanimous consent that all members in the 
subcommittee be permitted to place an opening statement in the 
record and the record remain open for that purpose. Without 
objection so ordered.
    I ask further unanimous consent that all witnesses be 
permitted to include their written statements in the record 
and, without objection, so ordered.
    And I also without objection ask that the gentleman's 
statement, Mr. Metcalf's statement, and report be included in 
the hearing record, and I will move to include it in the full 
committee hearing on anthrax next Thursday.
    You have been patient. Thank you very much. We will call on 
Mr. Harold Sox--Dr. Harold Sox, excuse me--professor and chair, 
Department of Medicine, Dartmouth-HitchCock Medical Center, 
accompanied by Samuel Potolicchio, who is professor, Department 
of Neurology, the George Washington University Medical Center. 
As you know, gentlemen, we swear you in and then we will take 
your testimony. If you would please stand.
    [Witnesses sworn.]
    Please be seated. I thank our other two staff for standing 
up in case you're required to make a statement. Thank you for 
anticipating that. It's very thoughtful.
    Dr. Sox.

STATEMENT OF HAROLD SOX, M.D., PROFESSOR AND CHAIR, DEPARTMENT 
OF MEDICINE, DARTMOUTH-HITCHCOCK MEDICAL CENTER, ACCOMPANIED BY 
 SAMUEL POTOLICCHIO, M.D., PROFESSOR, DEPARTMENT OF NEUROLOGY, 
        THE GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER

    Dr. Sox. Good morning, Mr. Chairman and members of the 
committee. My name is Harold Sox. I chair the Institute of 
Medicine Committee on Health Effects Associated with Exposures 
During the Gulf War, which released its report about 3\1/2\ 
weeks ago. I appreciate the opportunity to provide testimony to 
you today based on the findings of our report. And I am 
accompanied by Dr. Samuel Potolicchio, also a member of the IOM 
committee.
    The genesis of our report was a request from the Department 
of Veterans Affairs asking the Institute of Medicine to study 
the available scientific evidence on potentially harmful agents 
to which Gulf war veterans may have been exposed. Congress 
subsequently mandated a similar study specifying 33 specific 
agents. Before going further, I want to clarify the scope of 
the committee's work lest there be any misunderstanding.
    The committee, IOM committee, was charged with assessing 
the scientific literature about potential health effects of 
chemical and biological agents present in the Gulf war theater. 
The Department of Veterans Affairs will use the findings of the 
report as it sees fit as a scientific basis for developing a 
compensation program for Gulf war veterans. Our committee was 
not asked to examine whether a unique Gulf war syndrome exists 
or to evaluate the literature on Gulf war syndrome or 
illnesses. The committee was not asked to make judgments about 
individual veterans' level of exposure to the putative agents, 
as there is a presumption of exposure for everyone who served 
in the Persian Gulf theater.
    For the first study of the series, the Institute of 
Medicine chose to study the agents of most concern to the 
veterans who advised us: Sarin, pyridostigmine bromide [PB], 
depleted uranium, and the vaccines to prevent anthrax and 
botulism.
    Because there had been very few published studies of Gulf 
war veterans, most of the studies that we examined were about 
exposures in occupational, clinical and healthy volunteer 
settings. The committee members carefully assessed each study's 
quality, limitations and applicability, but it relied upon the 
peer review system that precedes publication in scientific 
journals as well.
    Let me begin with the nerve agent sarin. Relatively high 
doses of sarin can cause overstimulation of nerves and muscles 
within seconds or hours, creating symptoms such as severe 
cramping, difficulty breathing, twitching and heavy sweating.
    All of these short-term effects are well-documented and our 
committee ranked the evidence as sufficient to establish 
causality, the highest level of evidence. The long-term effects 
of sarin are a very different story. The evidence is far more 
limited in quantity and is weaker.
    Studies describing three different populations exposed to 
sarin, two involving victims of terrorist attacks in Japan and 
one involving industrial accidents in the United States, 
establish possible links to neurological and psychological 
symptoms that persisted for 6 months or longer after exposure. 
In one of these studies some symptoms were still present up to 
3 years after exposure. In all three studied populations, 
however, the patients all had an immediate, intense, widespread 
acute reaction, typical of high levels of exposure to sarin. 
Among the symptoms that persisted over the long term in these 
individuals were fatigue, headache, blurred vision and symptoms 
of post-traumatic stress disorder. It's important to remember 
that people who had long-term symptoms had all experienced 
intense symptoms immediately.
    Because we are dealing with only three studies and because 
we could not rule out explanations, other explanations for the 
effects, the committee categorized these findings as limited or 
suggestive of an association well shy of the evidence needed to 
establish a strong link, but clearly warranting further 
investigation. We recommend long-term research to track the 
health of victims of the sarin attacks in Japan, since 
controlled studies of them offer the best opportunity to see if 
sarin has long-term health effects.
    Few, if any, veterans reported symptoms of acute exposure 
to sarin in the Persian Gulf theater. Therefore we concerned 
ourselves with possible effects of sarin in doses too low to 
cause the acute reaction.
    Based on available evidence, we could not form a conclusion 
about an association between the long-term health effects and 
exposure to doses of sarin that are low enough so that 
immediate signs and symptoms did not occur. Yet research with 
nonhuman primates gives us a hint that low doses of sarin over 
a period of several days may create delayed neurological 
reactions. More research is needed to substantiate this single 
finding.
    The second agent that we considered was the drug 
pyridostigmine bromide [PB]. There have been many studies of 
the short-term effects of PB. The committee judged this 
evidence to be sufficiently strong to demonstrate an 
association between exposure and the immediate onset of mild 
transient symptoms, a link seen consistently in many studies. 
Long-term side effects of PB are another story. There simply 
was not enough evidence to draw any conclusion about PB's long-
term effects. In other words, we don't know if they occur and 
we can't be certain that they don't occur.
    The author of one series of studies has suggested that PB, 
either alone or in combination with other chemicals, may be 
related to some chronic changes in nerve function reported by 
Gulf war veterans. However, weaknesses in the design of these 
studies, which include uncertainty about whether exposures 
occurred and a small number of affected subjects, made it 
impossible for us to decide if exposure to PB is associated 
with long-term nerve damage. We recommend further investigation 
of this issue using an improved study design.
    The third agent was depleted uranium. Health effects of 
natural uranium have been widely investigated, mostly in 
occupational settings, principally workers in uranium 
processing mills. While these studies have shown that uranium 
either has no effect or only a small effect, our committee 
found weaknesses in many of these studies. We could not draw 
conclusions about exposure to uranium and death from a number 
of diseases, including lymphatic or bone cancer, nonmalignant 
respiratory disease and diseases of the liver and 
gastrointestinal tract.
    We were able to arrive at more certain conclusions 
regarding two diseases, kidney disease and lung cancer. We 
concluded that there is limited evidence of no association 
between kidney disease and exposure to uranium. We based this 
conclusion on adequate consistent studies that showed good 
kidney function despite continuous exposure to uranium as it 
dissolved from uranium fragments embedded in body tissues.
    Similarly, at low levels of exposure to uranium, we found 
limited evidence of no association between--with death from 
lung cancer. At higher levels of exposure, though, the evidence 
did not permit any conclusion about a relationship between 
uranium and lung cancer. We recommend followup research on 
veterans with embedded fragments of depleted uranium and other 
long-term studies.
    Finally, our committee considered the vaccines given to 
prevent anthrax and botulism. Based on our review of the 
scientific literature, we concluded that the evidence is 
sufficient to demonstrate an association between these vaccines 
and subsequent short-term local and systemic effects similar to 
those associated with any vaccination. But when we sought 
evidence for more lasting effects, we didn't find any 
published, peer-reviewed studies that systematically followed 
subjects over the long term. This situation is not unusual as 
vaccines are seldom monitored for adverse effects over long 
periods of time.
    Since troops usually receive several vaccines, often within 
a short span of time, some have questioned whether several 
vaccines in combination may have created a cumulative effect 
that would not occur with any single injection. Although we did 
find some research on cumulative effects of combinations of 
vaccines, the shortcomings in these studies made it impossible 
for us to form a strong conclusion. We did decide that this 
evidence was inadequate to determine whether an association 
with long-term effects exist.
    I have provided a brief overview of our report's findings. 
The IOM is beginning the second phase of the study, in which it 
will examine the literature on health effects of pesticides and 
solvents. This study is scheduled to be completed in 2002, as 
the committee must review a vast body of literature on these 
compounds. Plans for future IOM studies include completion of 
the studies of the remaining agents listed in the legislation. 
In addition, the IOM will update its studies and reports as new 
studies become available in the published literature.
    Thank you. Dr. Potolicchio and I will be happy to respond 
to your questions.
    [The prepared statement of Dr. Sox follows:]

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    Mr. Shays. You needed a cheat sheet like I had, 
Potolicchio, correct?
    Dr. Potolicchio. It's an Italian name. Just follow all the 
vowels.
    Dr. Sox. Sorry, Sam.
    Mr. Shays. Just trying to get back at all those tough 
medical names that you guys have. What we're going to do is 
we're going to start out with Mr. Sanders, I'm going to ask 
some questions, and then we've been joined--Ms. Schakowsky is 
here. I will recognize her third and then we'll go to Mr. 
Metcalf, who's not an official member of this committee, though 
he has all the rights to ask the same questions we will, but 
just then at the end. Mr. Sanders. And we're going to go 10 
minutes. We'll do 5 and 5, roll over 5.
    Mr. Sanders. Thank you very much, Mr. Chairman. Let me 
start off by asking you the question. You say in your 
statement, Dr. Sox, that for the first study of the series the 
Institute of Medicine chose to study the agents of most concern 
to the veterans, sarin, pyridostigmine bromide, depleted 
uranium and the vaccines to prevent anthrax and botulism. Now 
isn't one of the problems that we have is that we're sitting in 
a lovely room here in Washington, DC, but the reality of life, 
when you're at war, is that it may not be just one--there may 
not be just one agent that impacts on you. For example, 23, 
you're sitting there, you're scared to death, sitting in the 
heat, that the next day there may be a nerve gas attack on you. 
Psychologically what does that do to you? Meanwhile, at some 
point during the theater you may have been exposed to sarin, 
you may have been given a pyridostigmine vaccine, you may have 
had anthrax, you may have been exposed to burning oil wells, 
you may have a genetic disposition, you may have come from a 
place in your whole life you didn't absorb a lot of chemicals, 
so you're more susceptible to multiple chemical sensitivity. So 
my life history going into that battle is very different say 
than Mr. Shays. And so you add all of those things together, 
isn't there a problem that we're not looking at the totality 
and the synergistic impact rather than sarin here, depleted 
uranium here? Isn't there more to it than just one possible 
agent, and isn't that lacking in the way we're approaching this 
problem?
    Dr. Sox. Well, our--the answer to your question is yes. We 
need to be aware of the potential for interactions between 
different agents as well as potentially a person's past history 
of exposure and, in an ideal study, to try to look at the links 
between agents and combinations of agents. We would have a 
clear understanding of an individual's personal exposure 
history, both before and after service in a theater of war and 
then reliable information about subsequent health experiences, 
and then we would try to link those together and see if we can 
detect effects that would not be seen looking at a single 
agent. Most of the research on the health effects of the agents 
that we studied were on single agents. In fact, we found only 
one study in our search which suggested a possible link between 
two agents, one in which mice that were injected with PB were 
subjected to the stress of having to swim.
    Mr. Sanders. All that I am saying, and I have got a number 
of other questions, in the real world it is not just sarin, 
she's in the military, she's suffering trauma being there, and 
so forth and so on, that's the reality. It's not just we're 
sitting in a laboratory and we give somebody some sarin.
    No. 2, I want to make sure I understand exactly what your 
report says. Am I correct that you have not ruled out, not 
ruled out depleted uranium, pyridostigmine bromide, sarin gas, 
anthrax vaccine or multiple vaccines or some combination of 
these as the cause of Gulf war illness, you have not ruled them 
out?
    Dr. Sox. Our study was to look at the linkage between these 
four exposures and health effects, both diseases that are in 
textbooks as well as diseases that are not in textbooks because 
they're not well understood, such as Gulf war illnesses, and 
while we didn't find any compelling evidence that these 
exposures do cause health effects, neither was the evidence 
strong enough to conclusively rule out that they were not 
present. The closest we came was kidney disease and lung cancer 
with depleted uranium.
    Mr. Sanders. OK. I know that your mandate was only to 
review the peer-reviewed scientific literature on links between 
certain toxins and the symptoms that many Gulf war veterans are 
experiencing. Clearly, though, you had to undertake some 
background research into the types of symptoms these veterans 
are experiencing and the extent of those symptoms in order to 
do this analysis, is that correct?
    Dr. Sox. Yes, sir.
    Mr. Sanders. OK. Based on that background review, is it 
your medical opinion that in general Gulf war veterans are 
suffering from a physical illness or illnesses as opposed to 
what might be termed a psychological condition?
    Dr. Sox. Again, our committee charge was not to establish 
existence of a Gulf war syndrome. We read the published 
literature on this subject in order to provide background for 
our study of these compounds and their possible health effects, 
both on unexplained Gulf war illnesses as well as other 
illnesses. So if you want my personal opinion as a physician, I 
would say that ever since the Civil War, veterans of combat 
have experienced unexplained symptoms, and there's a great deal 
of overlap as you look at the symptoms that they experience in 
war after war coming right down to the present. So there's no 
question in my mind but what veterans do suffer unexplained 
illnesses, but this is a personal opinion. It was not a 
judgment of our committee. We didn't look at that question.
    Mr. Sanders. In your medical opinion, based on the 
background research you did, in your own experience does the 
fact that over 100,000 Gulf war veterans out of a total of less 
than 700,000 soldiers who served in the Gulf war have some 
combination of these symptoms suggest to you that these 
conditions we refer to as Gulf war illness have a connection to 
service in the Gulf war? In other words, if you have 100,000 or 
more folks out of 700,000 who have come down with a variety of 
illnesses now, it could be absolutely coincidental?
    Dr. Sox. Well, again you're asking me to express a personal 
opinion, which is somewhat more informed than the average 
physician, but I am not expressing an opinion based on the 
findings of our committee, and based on my personal reading of 
those articles, I think that there's a relationship between 
service in the Gulf war and these unexplained illnesses, but 
that was not a subject of the study.
    Mr. Sanders. Based on your own personal experience.
    Dr. Sox. My own personal reading of those articles.
    Mr. Sanders. I appreciate that. In your view, is it 
possible that we will never establish the precise cause of Gulf 
war illness other than to conclude that it has some connection 
to service in the Gulf war.
    Dr. Sox. I don't know how to answer that, sir. We have a 
number of exposures still to study and I would not want to form 
a judgment about what those studies might find. I don't have an 
opinion on that.
    Mr. Sanders. My last question is: Would you please explain 
what steps you took, if any, to obtain data from the DOD? Were 
they cooperative; were they not cooperative? You apparently did 
not get to review the classified materials. Did you request to 
and do you have staff who have security clearances?
    Dr. Sox. Well, we did not actively seek DOD documents. Our 
charge was to study the published peer-reviewed literature, and 
there's a history of several hundred years that states that 
reliance upon scientific reports that have undergone peer 
review forms a credible basis for forming scientific judgments. 
And DOD documents, they are not scientific reports and so--but 
to answer your question briefly, we did not seek them. We were 
not interested in the level of exposure of individual veterans 
because that's something that because of presumption of 
exposure exists.
    So it wasn't part of our charge to study DOD documents, and 
we did not request them.
    Mr. Sanders. Mr. Chairman, thank you very much.
    Mr. Shays. Let me, if you don't mind, not on anybody's 
time, but just ask Mr. Potolicchio if he would want to respond 
to any of those questions that you asked. Is that all right?
    Mr. Sanders. Sure.
    Mr. Shays. And then you can followup.
    Dr. Potolicchio. I think Dr. Sox has answered the questions 
appropriately.
    Dr. Sox. If you think I am not doing a good job, you will 
interrupt.
    Mr. Shays. Let me say because you're both partners here, 
you had one statement, but I don't mind if a question is 
directed to one of you to have the other jump in either with a 
qualifier or with whatever. I'd like either one of you to 
respond to--first, I'd like to just make a point. I wrestle 
with the fact that in terms of criminal law you're presumed 
innocent until guilt is proven and not, at least in the United 
States, presumed guilty until proven innocent. But I have the 
feeling that veterans are basically sentenced guilty because 
they're ill and they're guilty with no help in sight, and I 
have this general view that's come about through so many 
hearings that because there isn't a proven study or something 
that documents, therefore they're not going to have the 
presumption of an illness caused by their experience in the 
Gulf and therefore they are not going to get the help, not 
because there isn't that connection but because we can't 
illustrate that in fact there is that connection. And I 
understand where you come from as doctors and I think you 
understand where we come from as people who actually sent them 
off to war. And so I'm troubled by the fact that we still have 
a system that is not going to help our veterans and that maybe 
20 years from now they will prove there was this connection but 
by then it will be too late.
    So I don't have the same kind of patience that I think some 
people have. My understanding is that you have looked at sarin, 
you've looked at pyridostigmine bromide, you've looked at 
depleted uranium, and you're looking at vaccines that were 
intended to prevent, deal with anthrax and botulism, and it's 
my understanding that the committee--let me say this to you 
before I ask the specific question. It's also my sense that the 
bill we passed makes the presumption of exposure to 33 agents; 
in other words, that at least we're not going to debate about 
it and then allow--that is the keyword, ``allow''--the VA to 
establish a presumption that the exposures are related to 
illness and they're going to look at what you all have done and 
they are going to come to some conclusion. It allows but does 
not require.
    Now when you tried to establish the categories of 
association from previous IOM studies, you would first agree 
that in some cases you were hampered by the fact there weren't 
enough studies, is that correct?
    Dr. Sox. Enough studies.
    Mr. Shays. I'll start with you, Dr. Sox.
    Dr. Sox. Well, there were not enough studies of a quality 
that allowed you to make a scientific conclusion, yes, sir.
    Mr. Shays. But not necessarily related to war experience?
    Dr. Sox. Well, there were very few studies related to war 
experience. Most of them are in other settings, yes, sir.
    Mr. Shays. And none of these studies would enable you to 
deal with the isolated--all things being equal, you look at a 
particular agent and then you've come up with some conclusions, 
is that correct? In other words, everything else is frozen?
    Dr. Sox. Most of them are isolated studies in which you 
looked at one exposure in isolation of others.
    Mr. Shays. And so you would certainly acknowledge, as I 
think Mr. Sanders has pointed out, that all things aren't 
equal, all things aren't held constant, there's exposure 
potentially to something but there's also exposure to others?
    Dr. Sox. Yes, sir.
    Mr. Shays. Would you make any comment, Dr. Potolicchio?
    Dr. Potolicchio. Maybe just one brief comment and that is, 
for instance, if you take two of the agents that we're 
considering here, pyridostigmine and sarin, actually one of 
them is given in order to protect the individual from exposure 
to the other. So they are given, they're sort of given 
simultaneously, but one hopefully is going to be protective and 
there's scientific evidence to prove that's the case.
    Mr. Shays. Did you look at any studies that tried to 
determine what would happen if someone took more than the 
required allotment of PB? For instance, I have this tendency if 
I am putting fertilizer on my lawn, at least I did, that if one 
bag was good, two bags was better and three bags would be 
really terrific and I ended up with a lawn that was totally 
dead, and I know for a fact from our witnesses that we had some 
who took the pill far in excess of what was recommended, far in 
excess. They went through that same logic. Did you look at any 
study that would have helped you determine that?
    Dr. Potolicchio. There were, we know from--and there's 
clinical evidence that if you take a whole bunch of 
pyridostigmine, let's say hundreds of pills, that you're going 
to really get sick, vomit and know that you have taken it, and 
I think that clinical response at least, tells you that we 
better not take anymore.
    Mr. Shays. You know that from just observation, but did you 
look at any studies? In your peer review that dealt with taking 
too many pills, not your intuitive sense. But did you, was that 
part of your reviews and what reviews did you do? I'd like to 
know specifically.
    Dr. Potolicchio. Well, there are case reports of people 
being overexposed to certain agents, particularly 
pyridostigmine, and they will have clinical signs. But were 
studies taken in a double blind fashion that, you know, we were 
going to see how much can a person take of the drug, just to 
see what the side effects are going to be? No.
    Mr. Shays. No. The view--we have had extensive testimony 
from MDs that have said that once you've taken so many you open 
yourself up to exposures that you wouldn't have been opened up 
to before, and the question I'm asking you is have you looked 
at anything in that regard?
    Dr. Potolicchio. The only studies that look at large doses 
of pyridostigmine are those confined to myasthenics; in other 
words, myasthenics have taken relatively large doses of 
pyridostigmine over a long period of time and there really 
haven't been any long-term health consequences of that. But as 
far as acute exposure to very large doses, will pyridostigmine 
kill you basically? We know well that sarin in little drops 
will kill you, but pyridostigmine will not kill you.
    Mr. Shays. That's not what I'm asking. See, if you had been 
on this side you would have been, you would have been exposed 
to what we were, and that was that we had--we'd start our 
hearings from sick veterans who would explain to us that they 
were given really no instructions on what to do with these 
pills and that they didn't take them for days and then they 
took a lot of them, and then we had researchers come in and say 
that the impact on your brain and what it does in terms of it 
opens up the potential for other illnesses, so--do you want to 
just jump in?
    Mr. Sanders. Mr. Chairman, perhaps you have a better memory 
than I do, but I recall that we had the pharmacologist from 
Maryland, Dr. Teet, I believe his name was, who if I remember 
correctly said that that there is evidence if you are--it's one 
thing to take PB before exposure to sarin, which is the goal of 
presumably what that benefit was, but that if you take PB after 
the exposure to sarin it has an extremely negative impact. 
That's my memory, and I was wondering if they had looked at 
that.
    Dr. Potolicchio. There is, there is evidence that that's 
true because, you know, sarin, remember sarin is an agent that 
irreversibly blocks your cholinesterase. So in other words, 
once you're exposed to it and that cholinesterase is basically 
crippled, therefore if you take another anticholinesterase on 
top of it after having that acute exposure, obviously you're 
going to amplify that. That's true. I don't disagree with that.
    Mr. Shays. The question I'm asking is was that part of your 
peer review?
    Dr. Potolicchio. The study that you're referring to is done 
only in animals. There is no evidence in humans that that kind 
of after exposure is going to lead to further compromise.
    Mr. Shays. I still want an answer, though. It wasn't part 
of your peer review because there were no studies?
    Dr. Potolicchio. In animals.
    Mr. Shays. But there were no studies in humans?
    Dr. Potolicchio. There are no studies in humans.
    Mr. Shays. So it's not part of your peer review?
    Dr. Potolicchio. Correct.
    Mr. Shays. So what am I supposed to conclude in that? And 
what I conclude, I think, is that it kind of relates to your 
observation about peer review, there's no peer review there, 
but I'll tell you what happened when your report came out. The 
press said there's no linkage, you've discounted and--but it's 
like not having all the facts, and this is what--you know, I 
know you're doing your best but the bottom line is what are we 
supposed to conclude.
    Dr. Sox. Well, no evidence isn't the same as evidence of no 
effect.
    Mr. Shays. Say that again.
    Dr. Sox. No evidence is not the same as evidence of no 
effect. So clearly the press, if they concluded there was no 
effect, made a mistake.
    Mr. Shays. I understand, but that's the reality.
    Dr. Sox. Yeah.
    Mr. Shays. Would you walk me through, and then I will go to 
my colleague, on the concept of sufficient evidence of a causal 
relationship, sufficient evidence of an association, limited 
suggested evidence of an association, inadequate, insufficient 
evidence to determine whether an association does or does not 
exist, and then limited suggested evidence of no association, 
so there are five categories. If you would walk me through 
those.
    Dr. Sox. It will just take me a minute to find them.
    Mr. Shays. Yeah, take your time.
    Dr. Sox. First of all, the causal relationship. The 
evidence fulfills the criteria for sufficient evidence of an 
association; that is to say, all of the other levels of 
evidence, and satisfies several of the criteria that have been 
used to assess causality.
    Mr. Shays. So that would be the most certain, you would 
have very little doubt there's evidence of a relationship?
    Dr. Sox. Yeah, it is very hard to----
    Mr. Shays. The causal relationship.
    Dr. Sox. Yes, sir.
    Mr. Shays. The cause and effect. The second one is 
sufficient evidence of an association.
    Dr. Sox. And that states that there's been a positive 
association between an exposure and a health outcome in studies 
where other factors that might confuse the interpretation of 
that relationship can be ruled out with reasonable confidence, 
so that you think you can focus just on the exposure and not on 
other factors that might lead to the same result.
    Mr. Shays. The next one is limited suggestive evidence of 
an association.
    Dr. Sox. Here there's, there is evidence of an association 
between an agent and health outcomes, but the strength of the 
conclusion that you can draw is limited because you can't be 
sure that other factors that might explain the results aren't 
present. So you might have four or five things that could 
account for the result, one of which is the exposure. You can't 
be sure that the other ones aren't there and accounting for at 
least part of the effect.
    Mr. Shays. We have two more. Inadequate, insufficient 
evidence to determine whether an association does or does not 
exist, and I would assume that's neutral, you can't go either 
direction?
    Dr. Sox. It doesn't change your thinking one way or the 
other. It's like there isn't any information.
    Mr. Shays. But the first three lead you toward----
    Dr. Sox. Uh-huh.
    Mr. Shays. The last one is limited suggested evidence of no 
association. So we have those five. If you would just quickly 
tell me, sarin fit which category again?
    Dr. Sox. Well, the acute effects of sarin were a causal 
relationship.
    Mr. Shays. So that's the strongest you could have.
    Dr. Sox. Yes, sir. And then there were long-term effects in 
people who experienced the acute effects and that came in the 
limited suggestive category.
    Mr. Shays. OK. That was just one higher than neutral?
    Dr. Sox. Inadequate, yes, sir, and then----
    Mr. Shays. PB.
    Dr. Sox. Just to finish on sarin, evidence for long-term 
effects in people who did not experience any short-term effects 
of sarin, there was just no information except the one study in 
primates, which obviously requires a lot of followup.
    Mr. Shays. OK. And PB.
    Dr. Sox. In PB, the evidence was sufficient of an 
association between PB and acute effects lasting pretty much 
during the day that you took it.
    Mr. Shays. No long-term harm?
    Dr. Sox. But in terms of long-term effects the evidence was 
inadequate to determine whether there was or was not an 
association.
    Mr. Shays. But you didn't look at whether PB then opened 
the door for other illnesses with other agents? I mean, that's 
on the record, correct?
    Dr. Sox. There wasn't, there weren't any studies that 
showed us that PB opens the door to other exposures causing, 
leading to illness, yes, sir.
    Mr. Shays. Thank you, and depleted uranium.
    Dr. Sox. Depleted uranium, with two exceptions, the 
evidence was inadequate to determine whether an association 
does or does not exist. The two exceptions were lung cancer and 
kidney disease and in those cases there was limited or 
suggestive evidence of no association.
    Mr. Shays. OK. And then finally, vaccines to prevent 
anthrax and botulism?
    Dr. Sox. There was sufficient evidence of an association 
between immunization or vaccination and acute effects lasting a 
day or two, the sort of thing that many of us in this room have 
experienced. But the evidence was insufficient, similarly, just 
wasn't there. The studies weren't there----
    Mr. Shays. You couldn't determine one way or the other?
    Dr. Sox [continuing]. To determine any long-term effects.
    Mr. Shays. So that's a neutral issue?
    Dr. Sox. Yes, sir.
    Mr. Shays. Thank you very much, and, Ms. Schakowsky, I do 
appreciate your patience. Thank you.
    Ms. Schakowsky. Thank you very much, Mr. Chairman. I 
haven't been here as long as the chairman or Mr. Sanders, but I 
have to tell you that in the hearings we have had regarding 
issues where we put our people in the Armed Services in harm's 
way and the kind of information we had, it has been very, very 
frustrating. It seems in some ways that the policy of our 
government is no news is good news or no findings are good 
findings or no studies are good studies. And I'm looking 
through your testimony, Dr. Sox, and I see words like ``limited 
studies.'' Because of the limited studies in Gulf war veterans, 
when it comes to long-term health effects of these substances, 
the bottom line is we simply don't know enough on PB. There 
simply was not enough evidence to draw any conclusion about PB. 
In other words, we don't know long-term effects, if they occur, 
and we can't be certain if they don't occur. Weaknesses in the 
design of these studies made it impossible for us to decide.
    When it came to anthrax and botulism, we've had lots of 
hearings on anthrax. When it came to evaluating more lasting 
effects, we didn't find any published peer review study. I'm 
saying pretty much what everybody has said already. This is not 
unusual. As few vaccines have been monitored for adverse 
effects over long periods of time. When it comes to 
combinations, you say the shortcomings in these studies made it 
impossible for us to form a strong conclusion, and I am 
wondering if we're going to go on for another 10 years, and I 
realize this isn't your fault.
    I'm just trying to ask you what we can do about this. We 
come and say, well, someone studied your study and what they 
found was there wasn't enough information. We keep doing 
studies of studies that have been done that say there hasn't 
been enough study. So I'm wondering when we get down to doing 
some real study and what your recommendations would be so that 
next time we have a study we can come back with some real 
reports.
    Dr. Sox. Well, the wheels of research grind slowly.
    Ms. Schakowsky. Are they in process?
    Dr. Sox. Pardon me.
    Ms. Schakowsky. Are they in process?
    Dr. Sox. Basically physicians have known about postwar 
syndromes, as I said, since the Civil War and, from my 
understanding, serious research into the cause of those 
syndromes really has only begun after the Persian Gulf war. So 
we're, in my opinion, at the beginning of serious, careful 
study of an important group of illnesses that have existed for 
100, nearly 140 years and it's going to take a while to 
accumulate good evidence.
    LBJ declared war on cancer in 1968 and we have made a lot 
of progress in understanding the biology of cancer, but 
actually we're only now beginning to see some results or 
promise of some results from that research 30, 35 years later. 
I'm optimistic that we're starting on a process that's going to 
lead us to answers, but I don't expect the answers to come 
quickly.
    Ms. Schakowsky. Well, inconclusive results of real clinical 
studies that happen, that's one thing, and research that's 
being done, but I'm just wondering what the protocols are, for 
example, if we had--we made a decision about how many anthrax 
vaccines, how many dosages we should give and etc., and then 
when we come back and say well, based on what, what is your 
knowledge of this, how do we know about its effectiveness and 
its side effects, short and, well, mostly long term, so at what 
point should we be doing these studies and I would say that, 
that with agent orange, I mean, we have known about these 
symptoms that result from exposures during wartime, but are we 
engaged directly in the kind of research right now, and if 
that's the case, I haven't really heard about it.
    I mean, we heard when it came to anthrax all kinds of these 
voluntary reporting systems and no real answer as to how are we 
going to determine the effects.
    Dr. Sox. Well I am not an expert on the current state of 
research on Persian Gulf-related illnesses. Dr. Feussner, who 
will be speaking to you shortly, I am sure can tell you what 
studies are being done.
    Ms. Schakowsky. Thank you.
    Mr. Shays. Thank you. Mr. Metcalf does not have any 
questions.
    Mr. Sanders.
    Mr. Sanders. Thank you very much Mr. Chairman. As I 
indicated earlier because of the diligence of the chairman and 
his staff, we have had the opportunity on this committee to 
hear from, seems to me, some extraordinary researchers all over 
this country who have been doing breakthrough work, and there 
are a number of them, and I don't recall all of them, but I 
just was kind of curious, two names come to my mind, and I 
wonder if you can give me your views having reviewed their 
works.
    Dr. Robert Hayley is with the University of Texas, and as I 
recall, not having his work in front of me, he is not ambiguous 
about his belief that exposures in the Gulf have resulted in 
brain damage, which are causing severe physical problems for 
Gulf war veterans, no ifs, ands, buts and maybes, that is his 
belief. What's your view on that?
    Dr. Sox. Well, the committee carefully examined Dr. 
Hayley's work and had the opportunity to talk with Dr. Hayley 
about his work at one of our open sessions, and the committee 
ultimately concluded that there were difficulties with the 
design of Dr. Hayley's work that made it impossible to draw any 
conclusions at this point.
    I think our bottom line would be that in a small population 
of veterans, Dr. Hayley has done some studies that generate 
interesting ideas and hypotheses about the biological basis for 
some of the symptoms that people are experiencing, but until 
those studies are replicated by other investigators and larger 
more representative populations, the evidence that Dr. Hayley 
has produced is too weak for us to draw any conclusions upon 
which to base in our report.
    Mr. Sanders. Too weak in the sense that the number of 
veterans, the sampling was too small.
    Dr. Sox. Well, the sampling was too small. He studied 
basically a group of symptomatic veterans, and he, using some 
statistical techniques, put them in the subgroups which seemed 
to have different combinations of symptoms, and then he looked 
at different measures of brain function comparing one group of 
sick veterans to another group of sick veterans. It's a pretty 
basic principle of epidemiologic research to include an 
unexposed control, somebody who never went into the Persian 
Gulf theater, and with the exception of a couple of more recent 
studies, he has not had unexposed controls, but even putting 
that aside, the history of science is that you don't rely on 
one study. You, somebody does a study, and then several people 
try to replicate it. Sometimes they succeed and then it becomes 
part of the body of scientific understanding, and sometimes 
they don't and it falls by the wayside and right now, I think 
Dr. Hayley's work is in the category of remains to be repeated 
by other investigators.
    Mr. Sanders. Are other people, to your knowledge, trying to 
replicate that?
    Dr. Sox. I will have to ask Dr. Feussner to respond to 
that, I don't know.
    Mr. Sanders. What about Dr. Urnovitz.
    Dr. Sox. Doctor who?
    Mr. Sanders. Urnovitz.
    Dr. Sox. I don't know about his work. Sam, do you remember 
anything.
    Dr. Potolicchio. By name, I don't.
    Mr. Sanders. Don't know his name, no?
    Dr. Sox. None of us.
    Mr. Sanders. Dr. Claudia Miller, peer review.
    Dr. Potolicchio. Claudia Miller I think--we know we've had 
exposure to Claudia Miller.
    Dr. Sox. If I remember.
    Mr. Sanders. She's involved in multiple chemical 
sensitivity.
    Dr. Sox. She gave us a presentation. We did not review the 
literature on multiple clinical sensitivities and really don't 
have a basis upon which to judge her work.
    Mr. Sanders. See Mr. Chairman, may I repeat a point I made 
earlier, what seems to happen, and I think Ms. Schakowsky was 
making this point, we review people who say I don't know the 
cause of Gulf war illness, I don't have a cure to Gulf war 
illness, that's peer review. The people like Hayley or Urnovitz 
or Miller who say, you know, I think we're on to something, I 
think there's something real here, those are rejected because 
apparently not enough people have peer-reviewed that, we push 
them aside. It would seem to me, and correct me if I'm wrong, 
given the fact that after--and I don't mean to be critical of 
you. I know you're just one part. We've had 100 people up here 
who keep telling us the same thing.
    So we get a little bit frustrated, but when people come up 
here and they say I think we're on to something, it would seem 
to me that the logical reaction for Hayley's work or Urnovitz's 
work or Miller's work would be for people to jump up and down 
and say, thank God, we may have a breakthrough, why are we--are 
you recommending for example that resources now be devoted to 
replicate Hayley's work so that 5 years from now, we don't have 
people coming before us saying Hayley's work was interesting, 
but nobody's replicated it, so why don't we replicate it? Tell 
us that Hayley is wrong or he is right, or Urnovitz is wrong or 
is right.
    Dr. Sox. You know the history of scientific enterprise is 
somebody comes up with a finding and then somebody funds 
studies to try to replicate that study. So the answer to your 
question is yes, if somebody comes in here and makes a claim of 
an important result, the answer should be to fund other 
investigators to replicate the result.
    Mr. Sanders. I agree with you but based on that I mean all 
that you told me about Hayley, Urnovitz, you've never heard of 
Hayley. You said there is nobody, you know, he's out there, we 
don't have enough evidence to suggest that he is right or 
wrong, but you should be coming in here and saying this guy is 
saying something that's significant, it's different to other 
people, he's claiming some results, either he's crazy or he's 
not, let's find out; true?
    Dr. Sox. Well, yes and in our research recommendations, we 
called for work to replicate Dr. Hayley's findings.
    Mr. Sanders. One of the things that we can use--we have 
gone through this for 10 years, so what we would like people to 
say is look, there are some breakthroughs here, we cannot tell 
you at this moment whether these people are right or wrong, 
maybe they're wrong, let's find out and say that they're wrong, 
or if they are right, let's devote a whole lot of money to 
moving forward so we can use their research to develop a cure 
for Gulf war illness. I didn't hear you say that.
    Dr. Sox. Did you hear me say it?
    Mr. Sanders. No, I didn't hear you say it.
    Dr. Sox. Well----
    Mr. Sanders. For example, tell me now, based on all of your 
research, if you were the President of the United States, or 
better yet, if you were going to recommend to the President of 
the United States, Mr. President, we have got a problem and I, 
based on all of my research, advocate to you that you spend X 
dollars in the following areas because we have some promising 
breakthroughs, but we just don't know about it. What would you 
recommend to the President?
    Dr. Sox. Well, I would recommend to the President a program 
of research to try to replicate some of the interesting results 
of investigators like Dr. Hayley, but I probably also call upon 
the President to establish a committee, to establish research 
priorities so we don't just focus on the areas where some 
scientists are working, but also going out and looking at areas 
where nobody has looked yet, perhaps for lack of funding, so in 
other words, we need a comprehensive approach to the study of 
postwar illnesses, and part of that approach is to followup on 
promising results of investigators like Dr. Hayley.
    Mr. Sanders. But that's where we were 10 years ago. You've 
studied all of the literature. So I am asking you, all right, 
give me, at this point, if you can, who are the people out 
there that you see are doing breakthrough work that, in fact, 
need help right now for additional funding so that we can 
determine whether they're right or whether they are wrong. Is 
Hayley one of them?
    Dr. Sox. I don't know anything about Dr. Hayley's funding, 
but clearly, Dr. Hayley is studying veterans and coming up with 
some interesting results, but I'm not sure it's Dr.--that Dr. 
Hayley needs more money. It may be that other people need more 
money to followup on his studies and to take it to the next 
step.
    Mr. Sanders. That's fine I am not here defending Dr. 
Hayley. All I am saying is you've done a lot of research; 
you're a scientist we are not. You have studied the literature. 
Can you just tell us who are the people out there you are 
thinking that you think are doing breakthrough work that we 
should try to give more support to?
    Dr. Sox. Well, the only name that comes to mind is Dr. 
Hayley. I do believe that the Baltimore group has been studying 
the veterans with depleted uranium fragments needs continued 
support but if--but I really don't think that I should be the 
person to tell you who ought to be funded. I think that's 
something for more deliberation.
    Mr. Sanders. In all due respect, I disagree with that. We 
need guidance. We are not scientists, you are, and what we need 
help on is for somebody to come before us and say look these 
guys have been doing this stuff for 10 years. It's going 
nowhere in a hurry, this is possible, this is potential we do 
need that kind of help Mr. Chairman.
    Mr. Shays. The other place we need help is when you're 
looking at what studies are available and you realize there 
just aren't any peer review studies in certain areas. I'd like 
to--in general, I'd like to read one paragraph, then we're 
going to get on to the next panel, unless Ms. Schakowsky has 
any questions. But this is the paragraph on page 3. It's a 
fairly long one, but I am going to read it all to you. It 
starts out--it's kind of in the middle of the page.
    All these short term effects are well documented, and we 
rank the evidence as sufficient to establish causation, the 
highest level of evidence. In part, this means--and we're 
talking about nerve agent sarin--in part, this means many 
studies have strongly repeatedly and consistently linked these 
acute health effects and exposures to sarin, and that the 
greater the exposure, the greater the effect, but the long-term 
effects of sarin are a very different story. The evidence is 
far more limited and much weaker.
    Studies describing three different populations, two 
involving victims of terrorist attacks in Japan and one 
involving industrial accidents in the United States, link 
neurological and psychological symptoms that persisted for 6 
months or longer. In one of these studies, some symptoms 
persisted for up to 3 years, the longest that any of the 
subjects were followed.
    In all three studied populations, however, the doses of 
sarin were high enough to trigger an immediate, intense 
widespread and acute reaction. Among the conditions that 
persisted over the long term were fatigue, headaches, blurred 
vision and symptoms of post traumatic stress disorder. I might 
just say parenthetically, that's a very common symptom for our 
veterans who have come before our committee. In other words, 
people who had long-term symptoms were the ones who had 
experienced intense symptoms immediately.
    Now, I want--the keyword here is ``intense.'' How did you 
define ``intense?'' Was it walking intense or drop dead 
intense? I mean, fall down intense? What defines ``intense?''
    Dr. Potolicchio. The level of exposure was based only on 
clinical findings, and maybe one laboratory test when it was 
available. You know, there is no real exposure data on sarin in 
any of the Japanese populations. We don't know how much any 
individual got at any time. If you look at the reports and the 
way they were written up, there was a man that was 100 feet 
from the release of the gas in Matsumoto, Japan, and he opened 
the window of his room and that man eventually died in 
convulsions and respiratory arrest, and he was just a few 
hundred feet away, but he probably had a maximum exposure but 
nobody knows exactly how much.
    Mr. Shays. I am just trying to understand.
    Dr. Potolicchio. The thing is that when you get to the 
clinical findings, you say, well, there has to be an intense--
in other words, someone's had an exposure, he, at least, had 
some symptoms of exposure that we recognize and that would be 
the acute cholinergic syndrome.
    Mr. Shays. I understand that.
    Dr. Potolicchio. Or the enzyme that you measure in the 
blood is depressed to such a degree----
    Mr. Shays. Let me not get to that. Let me just get to your 
concept of ``intense,'' and I want to relate ``intense'' into 
war. I mean, I can remember when I was being chased by some 
older kids who wanted to beat me up, I've never run so fast. I 
didn't even know that I was exhausted. I was so damn afraid. I 
ran across a highway without looking either direction, and as 
far as I was concerned, I was pretty healthy, but later I 
realized I was just, I was just totally--I was sore, I was 
always these things and I was sore when I was running, but I 
didn't know that. I didn't have people shooting at me. So I 
guess what I'm trying to determine is are you making an 
assumption that there was not an intense exposure in the Gulf 
because people didn't fall down or something?
    Dr. Potolicchio. We're not making an assumption about 
anything that happened in the Gulf war theater. We're saying if 
you have an exposure to sarin, you will have acute symptoms. 
Now whether or not you can identify those----
    Mr. Shays. Describe those acute symptoms, please.
    Dr. Potolicchio. Well, your acute symptoms would be----
    Mr. Shays. Would be fatigue, headaches, blurred vision, 
what?
    Dr. Potolicchio. No.
    Mr. Shays. What would they be?
    Dr. Potolicchio. Your acute symptoms would be difficulty 
breathing, watery eyes, probably GI upset, in other words, 
gastrointestinal upset, your muscles might start to twitch, and 
you can actually go into a convulsion if the exposure is 
intense enough.
    Mr. Shays. But not necessarily. All those symptoms I would 
wager our veterans have experienced in the Gulf, not all of 
them but a good number, blurred vision.
    Dr. Potolicchio. You wager they have been exposed to that?
    Mr. Shays. We had testimony of people describing those very 
symptoms, not after but during. OK. So the symptoms you have 
described, just for the record I will state, was statements to 
us by veterans that they experienced in the theater, clearly. I 
think we're all set unless you have any, Ms. Schakowsky, any 
questions. Thank you all very much.
    Our next witnesses are John Feussner, Dr. John Feussner 
sorry, chief research and development officer Department of 
Veterans Affairs accompanied by mark brown Ph.D. director 
environmental agents study, department of Veterans Affairs. Do 
you all have anybody else that would help you in any testimony? 
If so I would ask them to stand up. Thank you and if you're 
asked to then respond, we would check out the names. I ask you 
to raise your right hands please.
    [Witnesses sworn.]
    Mr. Shays. Note for the record that our witnesses have 
responded in the affirmative and Dr. Feussner, you will be 
making the statement, and Dr. Brown you would also be 
responding to questions. Thank you very much. Appreciate your 
patience.

STATEMENTS OF DR. JOHN FEUSSNER, CHIEF RESEARCH AND DEVELOPMENT 
 OFFICER, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY MARK 
     BROWN, Ph.D., DIRECTOR, ENVIRONMENTAL AGENTS SERVICE, 
                 DEPARTMENT OF VETERANS AFFAIRS

    Dr. Feussner. Mr. Chairman and members of the subcommittee, 
thank you for this opportunity to discuss the status of the 
current Federal research program on Gulf war veterans 
illnesses. Accompanying me today is Dr. Mark Brown, who is the 
director of the VA's Environmental Agents Service.
    In your invitation letter, you indicated that the purpose 
of the hearing was to review the findings and recommendations 
of the recent Institute of Medicine report. You also requested 
a discussion of the plans for additional research by the IOM 
and a status report on other research on Gulf war veterans 
illnesses.
    To date, the Federal Government is projecting cumulative 
expenditures of $151 million of Gulf war research from fiscal 
year 1994 through fiscal year 2000. There are over 192 projects 
at various stages of completion in the research portfolio on 
these veterans illnesses.
    For the sake of brevity, Mr. Chairman, I will only 
summarize the research recommendation of the Institute of 
Medicine report and the response of the research working group.
    With regards to sarin specifically, the IOM has recommended 
long-term followup of populations exposed to sarin in the 
Matsumoto and Tokyo terrorist attacks. The research working 
group concurs with the IOM recommendation.
    The IOM recommends studies in experimental animals to 
investigate the long-term effects of acute, short-term 
exposures to sarin at doses that do not cause overt cholinergic 
effects. Since 1996, the DOD has funded nine toxicology studies 
focusing on the effects of sarin, alone or in combination.
    In addition to the IOM recommendations on animal studies on 
sarin, the research working group is coordinating three 
epidemiological studies that are focusing on the health of 
veterans potentially exposed to low level sarin due to the 
Khamisiyah demolitions, one at the Navy Health Research Center, 
a second at the Oregon Health Sciences University, and a third 
by the Medical Followup Agency of the Institute of Medicine.
    In addition to the IOM recommendation on animal studies on 
sarin, the research working group also is coordinating a 
contract to the medical followup agency to perform an 
epidemiologic study of the long-term effects of short-term 
exposure to nerve agents in human volunteers in experiments 
conducted at the Aberdeen Proving Ground in the 1950's to 
1970's.
    With regard to pyridostigmine bromide, the IOM recommends 
research on chemical interactions between PB and other agents, 
such as stressful stimuli and certain insecticides. Since 1994, 
VA and DOD have funded 30 projects related to PB alone or in 
combination with other chemicals or stressful stimuli. One 
important and consistent result of recent studies is that 
stressful stimuli such as swimming, heat or restraint stress do 
not cause an increase in the permeability of the blood brain 
barrier or cause pyridostigmine bromide to cross the blood 
brain barrier into the brain.
    The IOM recommends research on differences in genetic 
susceptibility that may contribute to increased risk of 
disease. VA and DOD have funded eight projects on genetic 
factors that may alter the susceptibility to the effects of PB 
or sarin.
    Concerning vaccines, the IOM has recommended long-term 
systematic research to examine potential adverse effects of 
anthrax and botulinum toxoid vaccination in multiple species 
and strains of animals. The research working group concurs that 
long-term research is needed to examine potential adverse 
effects. Such research is underway in DOD laboratories. Also, 
the CDC, the Centers for Disease Control and Prevention, plans 
to fund nonhuman primate studies of the health effects and 
efficacy of the anthrax vaccine later this year.
    The IOM has recommended identification of cohorts of Gulf 
war veterans and Gulf war era veterans for whom vaccination 
records exist. The CDC published a study of Air Force Gulf war 
veterans in 1998 which included measuring antibodies to anthrax 
and botulinum to determine which individuals had received the 
vaccines. The CDC found no relationship between the 
vaccinations and development of multisymptom illnesses.
    Similarly, researchers in the United Kingdom have also 
published a study this year on a cohort of nearly 1,000 Gulf 
war veterans for whom vaccination records exist. There was no 
association between having received the anthrax vaccine and the 
development of multisystem illness.
    The IOM has also recommended long-term longitudinal studies 
of the participants in the anthrax vaccine immunization 
program. In 1999, DOD funded a long-term longitudinal study of 
participants in the anthrax vaccine immunization program study 
located at the Naval Health Research Center.
    Finally with regard to depleted uranium, the IOM 
recommended continued followup of the Baltimore cohort of Gulf 
war veterans with DU exposure. The research working group 
concurs with the recommendation. While the Baltimore clinicians 
have seen no definitive evidence of adverse clinical outcomes 
associated with uranium exposure to date, the veterans who were 
involved in the friendly fire incidents will remain under 
continuing medical surveillance.
    The IOM has recommended continued followup of the cohorts 
of uranium processing workers. The research working group 
concurs with this recommendation.
    The IOM has recommended additional studies of the effects 
of depleted uranium in animals. DOD has funded five toxicology 
projects that are investigating the health effects of DU in 
experimental animals. For example, there was no detectable 
kidney toxicity in rats embedded with DU pellets, even at very 
high concentrations of urinary uranium.
    Mr. Chairman, we know that combat casualties do not always 
result in obvious wounds and that some veterans from all 
conflicts return with debilitating health problems. VA 
recognizes its responsibility for developing effective 
treatments and prevention strategies for such illnesses.
    Studies clearly show that some Gulf war veterans report 
chronic and ill-defined symptoms including fatigue, 
neurocognitive problems and musculoskeletal symptoms at rates 
that are significantly greater than nondeployed veterans.
    Mr. Chairman, thank you again for permitting me this 
opportunity to summarize our work. You have my assurance that 
we will continue this effort to resolve, or at least ameliorate 
health problems in our patients to the greatest extent 
possible.
    Mr. Chairman, I will conclude my testimony here and ask 
that you enter the entire written testimony into the record. I 
actually think you did that.
    [The prepared statement of Dr. Feussner follows:]

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    Mr. Shays. Already covered, but it doesn't hurt to ask. Let 
me just, before recognizing Mr. Sanders, say they wish a lot of 
these studies had begun 10 years ago. I think that many of them 
are very important and valuable. I think that it's good they're 
happening. I wish they could have happened sooner, but I guess 
we call that progress, and Mr. Sanders.
    Mr. Sanders. Thank you very much, Mr. Chairman. As you 
know, I have been very critical of the DOD and the VA for many 
years in this area, but I do want to single out Jack Feussner 
as somebody who I think for many, many years has been trying to 
do the right thing, Jack and I appreciate the work you have 
done.
    Let me just ask you, you remember, Dr. Feussner, a couple 
of years ago at a hearing, I had indicated to you that I was 
distressed that there was some apparently breakthrough work 
being done around the country, and I asked you if the VA had 
begun the process of trying to replicate some of that work, 
tell us whether it was right or wrong, and I think out of that 
discussion with Chairman Shays' help and so forth, you began a 
clinical trial based on I think the work of Dr. Nicholson in 
California dealing with doxycycline, and I know that clinical 
trial is going on in a hospital in White River Junction in 
Vermont, hospitals all over this country, and the thesis was 
that large doses of doxycycline over a long period than had 
previously been given seemed to indicate that there would be 
some alleviation of symptoms.
    That was Nicholson's hypothesis. You were testing it. Do 
you have anything to report to us today about the progress of 
that study?
    Dr. Feussner. Yes, sir, I have progress to report. You're 
quite correct, the study continues. You're also quite correct 
to assert that the treatment was doxycycline and the duration 
of the doxycycline was quite long, 1 year. Because this is a--
while tetracycline is not an experimental or novel therapy, the 
use of tetracycline----
    Mr. Sanders. Doxycycline is what we're talking about.
    Dr. Feussner. Yes, sir.
    Mr. Sanders. Tetracycline is the same?
    Dr. Feussner. Doxycycline is a specific brand of 
tetracycline. I will try to keep it straight. At any rate, this 
trial, as you recall, was planned as a collaborative effort 
between VA and DOD, went through a very rigorous scientific 
review process that actually included a formal request for an 
FDA IND, an investigational new drug not because the drug is 
investigational, but because the condition for which the drug 
is being used is not approved by the FDA.
    We initiated the trial formally in May 1999. The goal was 
to study--enroll up to 450 Gulf war veterans at 28 sites 
throughout the United States. We have achieved that goal. As a 
matter of fact, as we intended to close enrollment in the 
trial, we had a number of veterans who wished to participate, 
despite the fact that we had met our patient sample size quota. 
Nonetheless, we included an additional 41 veterans into the 
trial. The total sample size now is 491. The patient 
recruitment period is done and the patients are currently in 
the process of going through that 1-year treatment.
    Mr. Sanders. Does that include, that 491, is that some of 
those--half of those people are getting placebos?
    Dr. Feussner. Correct, yes, approximately 50/50.
    So the patients are all enrolled in the trial and are all 
now being treated with the active agent doxycycline, or 
placebo, are in the process of being followed on that treatment 
over the course of 1 year. I expect the study to be complete, 
the followup to be complete next summer, approximately June or 
so, and that we will have the final result some time after 
that, some time probably within the next 90 days of completion 
of the trial. So the trial has been a success.
    Mr. Sanders. In the sense of organizing it?
    Dr. Feussner. In the sense of organizing, recruiting 
patients, but I can't tell you what the results are yet.
    Mr. Sanders. So in June you will be beginning the process--
you'll be completing the study and beginning the process of 
analyzing the results?
    Dr. Feussner. That is correct. You may recall, Congressman, 
we also started another major trial, that one much more 
difficult. We call it exercise and behavioral therapy, 
organizationally more complex for treatment groups. Similarly, 
we have closed the patient recruitment for the EBT trial. There 
are four treatment groups, usual care, exercise only, cognitive 
behavioral therapy only or both interventions. We did not quite 
meet our goal for patient inclusion. We'd hope to have 
approximately 1,300 patients enrolled. We have succeeded, 
however, in enrolling 1,100 patients in the trial and the 
trial, whatever the result, will be statistically robust. So 
while we had hoped to have a few more patients, we are very 
gratified that 1,100 Gulf war veterans have volunteered to help 
us with the trial. That trial, as you recall, is a little later 
in the process than the ABT. I don't expect the final end point 
of that trial until the fall of 2001, and probably around 
September or so with the same issue that at that point, we will 
begin the analysis and should have the results--pretty good 
result within a 90-day period.
    Mr. Sanders. And I presume--is my time up, Mr. Chairman?
    Mr. Shays. No, no.
    Mr. Sanders. I presume that if one or both of those studies 
indicate that approach alleviates symptoms--that approach will 
become recommended form of treatment throughout the VA system.
    Dr. Feussner. Yes, I would say the answer to that question 
would be yes, that the trials, as you know, the trials are 
large, they're very expensive and they are constructed to be 
definitive. So that if the result is positive, then the 
treatment is known to work, and if the result is negative, then 
the treatment is known not to work.
    Mr. Sanders. Dr. Feussner, I am, as you know, not a 
scientist, and the way my mind works, as I mentioned to you 
before, and I appreciate you moving with that type of approach, 
is that if somebody is doing interesting work, we test the 
hypothesis, and frankly, this work was based on what Nicholson 
had indicated out in California, is that correct? More or less 
through other people?
    Dr. Feussner. As you recall, sir, Dr. Nicholson's work was 
quite controversial.
    Mr. Sanders. I sure do.
    Dr. Feussner. There were two observations. While his 
results were controversial, one of our own physicians Dr. 
Gordon had anecdotal experience----
    Mr. Sanders. That's right.
    Dr. Feussner [continuing]. On his own in a significant 
number, not two or three, but perhaps several dozens of 
patients where he had observed clinically that he had tried the 
therapy and believed that the therapy worked.
    Mr. Sanders. Dr. Gordon from Manchester, New Hampshire?
    Dr. Feussner. Yes, sir.
    Mr. Sanders. That's right. And it seems to me that a good 
administrator, such as yourself, listens to those people, who 
may only have anecdotal evidence of some success. OK. So I am 
applauding you for this, but let me ask you this, getting back 
to the question I asked Dr. Sox a moment ago, if there appears 
to be some breakthroughs, what you're saying is if Dr. Gordon 
came to you and said listen, I'm applying this treatment, it 
appears to be working, let's go further with it and you said 
yeah, let's go further with it, Nicholson did his work, and I 
think you did exactly the right thing, what about the work that 
people like Hayley or Urnovitz or Miller are doing out there? 
There is also anecdotal evidence that there may be some 
breakthroughs. Are you prepared to say come on in, let's work 
together, let's see, in fact, to answer the question that Dr. 
Sox raised with Hayley's work that the sampling was too small, 
there hasn't been enough replication, are you going to help 
us--tell us whether or not Hayley is on to something or whether 
he's not?
    Dr. Feussner. Well, before we get to Dr. Hayley's work 
specifically, Congressman Sanders, you will recall that some 
years ago, I believe in 1998, that VA announced an open-ended 
what we call RFP, request for proposals, DOD calls BAA, broad 
area announcement, indicating our receptivity to treatment 
trials of any novel therapy agent. That RFP is still active, 
but I will concede that we perhaps should reannounce it just to 
make sure that those that need to know are reminded that that 
is still active.
    Mr. Sanders. What I am asking, Dr. Feussner, you know what 
I'm asking, are we welcoming in the door people who have 
controversial ideas who are not quote unquote, peer reviewed by 
folks who have not given us any information in 10 years? Are 
you having the courage to go out and say, look, people may--I 
may be attacked for going to somebody who is controversial, but 
I'd rather be attacked for going to somebody who is 
controversial and may contribute something to our knowledge 
rather than go back to the same old folks who 20 years from now 
tell us we don't know the cause. Are you prepared to do that, 
to take the heat?
    Mr. Shays. You recognize that's a loaded question, don't 
you?
    Mr. Sanders. You understand where I am coming from?
    Dr. Feussner. Sir, I certainly do understand where you're 
coming from, and what I would say is I think our actions do 
speak to that issue, and that is, that we have followed up with 
larger scale research, looking at reasonable testable 
hypotheses, specifically with regard to Dr. Hayley. Dr. Hayley 
published preliminary work in the Journal of the American 
Medical Association exploring possible definition for a number 
of Gulf war syndromes. You will recall that very early on after 
that work is published, I had the opportunity to testify before 
the committee. I think that Dr. Sox's point is well taken. Dr. 
Hayley studied a small number of study subjects. His response 
rate in the initial study, even in a highly selected patient 
population, was only 40 percent. There were no controls.
    But the observation bore attention, OK. I mean, he put 
something on the table. Now, the follow-on to that is it's--as 
you know, because we've talked about this a lot, scientific 
process. It's not important for the initial investigator to 
replicate his or her own work but for other scientists to do 
that.
    We have supported four follow-on studies looking at those 
syndromes, three in the United States and one in the United 
Kingdom. The United Kingdom was published in the Journal Lancet 
by Dr. Wesley. We have the Naval Health Research Center in San 
Diego. We have the CDC study of Fukuda and colleagues, and we 
have the Iowa study just recently published this year in the 
American Journal of Medicine. None of those studies is able to 
replicate Dr. Hayley's initial observations in terms of finding 
the kinds of unique syndromes that Dr. Hayley found in his 
preliminary hypothesis-generating research.
    What we are left with in that effort is, one, we have 
followed on the effort to replicate the work. We have not been 
able to replicate the work at this point in time. But actually, 
there is yet another study that we are supporting in 
collaboration with researchers at GW using the same analytical 
strategy, etc.
    Mr. Sanders. What you're saying is you've taken Hayley's 
work seriously, you're putting money and resources into trying 
to replicate it, at this point that has not happened.
    Dr. Feussner. In that particular one we have not been able 
to replicate the work.
    With regard to the work on the structural brain disease, we 
have talked about that at the hearing in February, and we have 
a number of studies ongoing that are looking also at structural 
brain disease. The most--and so, an effort is underway to try 
to explain, replicate, extend that observation. The most recent 
observation, actually I haven't had an opportunity to go over 
in detail myself. It is quite recent, within the last week or 
so, looking at neurotransmitters, chemicals in the brain that 
tell other parts of the brain what to do, and since the brain 
tells the rest of the body everything to do, very important, 
called--dopamine is the chemical.
    We haven't taken a hard look at that yet, but what I will 
tell you, the worry here has to do with Parkinson's disease, 
and independent of this issue with Hayley, VA is currently 
reviewing, as a result of another RFP VA is currently 
reviewing, and hopefully later this calendar year will fund up 
to six major centers, research centers devoted to the study of 
Parkinson's disease and movement disorders. We call them 
PADRECC's, Parkinson's Disease, Research Education and Clinical 
Centers, modelled after the VA-funded geriatric centers. So 
that we will have the capacity, I believe, within--at least 
within VA, certainly within the broader scientific community, 
to follow on those observations.
    So I think what I'm doing, Congressman, is giving you a 
long answer to a short question.
    Mr. Sanders. It's a good answer. Let me ask you this and 
I'll give the mic back to the chairman. I remember, sometimes 
there are instances where things occur and you never forget 
them, but I remember meeting with many Vermont veterans who are 
suffering from Gulf war illness, and one of the symptoms, many 
of them relayed to me is when they were exposed to perfume or 
detergent smells or other chemical presence, gasoline fuels, 
they would become sick, which suggested to me that we're 
looking perhaps at what might be called multiple chemical 
sensitivity, and as you know, I am sympathetic to the work that 
Dr. Claudia Miller and others are doing. Can you tell us a 
little bit about some of the research the VA may or may not be 
doing in following up on the issue of multiple chemical 
sensitivity in Gulf war illness?
    Dr. Feussner. I think what I would have to say, Congressman 
Sanders, is that the last time you asked that question, I don't 
have much of a different answer to give you this time. We have 
about half a dozen or so research projects looking at the issue 
of multiple chemical sensitivity. They're currently active. In 
a response to a meeting that we had with you in your chambers 
some time ago, we invested a considerable amount of energy 
trying to forge a collaboration between Dr. Miller and VA 
investigators, both in San Antonio and, as I recall, in Tucson 
with Dr. Iris Bell, who's testified before you in the past.
    We have also indicated, as you know, the interest in 
explicitly looking at prospective treatment trials and also, as 
you know, some of the difficulty in pursuing those ideas 
aggressively relate to the infrastructure that is required in 
order to do the research. It's not as----
    Mr. Sanders. Let me just jump in and bring this to the 
point. To the best of my knowledge the U.S. Government, despite 
the widespread feeling of many physicians, certainly not all, 
that multiple chemical sensitivity is a serious disease not 
only facing Gulf war veterans but the American population. 
Correct me if I'm wrong, Dr. Feussner, but I don't know that 
the Veterans Administration or DOD owns what is called an 
environmental chamber where we can do scientific studies 
regarding treatment of multiple chemical sensitivity. Is that a 
fair statement? I know we're trying to get funding for it, but 
it's beyond my comprehension that the U.S. Government doesn't 
own one of those units quite yet.
    Dr. Feussner. I think I answered that question the last 
time and said yes, the U.S. Government does own these 
facilities. I am searching my hard drive to find those data, 
sir. What I can tell you is the VA does not. I can't recollect 
about DOD. I do recollect that EPA has such laboratories in the 
research triangle in North Carolina, and I do believe that DOD 
has several of these facilities, but I cannot remember the last 
time I looked this up. I'll have to----
    Mr. Sanders. Short term memory loss, multiple chemical 
sensitivity, there it is. Thank you very much, Mr. Chairman.
    Mr. Shays. I'm just going to have a slight advertisement 
for a committee meeting that we're having next week on Gulf war 
illnesses. The Royal British legion formed a Gulf veterans 
group some years ago to provide a focus for Gulf veterans 
issues. It is made up of Gulf veterans, parliamentarians, 
representatives of VSOs and service welfare organizations and 
medical and scientific advisers. A delegation from the Gulf war 
veterans group visited the United States in July 1995 and 
similar group intend to visit Washington, DC, from October 2nd 
to 6th. We will be meeting with a group on Wednesday, October 
4th from 10 a.m. in room 2154 with Lord Morris, the 
distinguished parliamentarian, with a background in trades and 
union members; Colonel Terry English, director of welfare at 
the Royal British legion; Kathy Walker, director of welfare, 
the Soldiers, Sailors and the Airmen Families Association; Dr. 
Norman Jones, medical adviser, Royal British Legion; Mr. John 
Nichol, author, Gulf war veteran and ex-POW; Professor Malcolm 
Hooper, scientific adviser, Gulf Veterans Association.
    Let me first ask you, Dr. Brown, is there anything that you 
would want to respond to Mr. Sanders, any comment or 
observation?
    Dr. Brown. No. When it comes to research issues, Jack is 
your man.
    Mr. Shays. OK. Well, I'll ask either one of you, how many 
of the 83 research projects--there are 192 research projects in 
Gulf war veterans illnesses at various stages of completion, 83 
have been completed, and I want to know of the 83 projects 
completed, how many have been published and peer reviewed?
    Dr. Feussner. I'll have to get that information for you, 
Congressman Shays.
    Mr. Shays. Could someone else give us that?
    Dr. Feussner. We don't have that off the top of our heads.
    Mr. Shays. How many completed projects involve sarin and 
have been published and peer reviewed?
    Dr. Feussner. I will have to get those data for you as 
well.
    Mr. Shays. How many involving PB?
    Dr. Feussner. How many are already finished and published?
    Mr. Shays. Published and peer reviewed.
    Dr. Feussner. I think it's approximately six to eight.
    Mr. Shays. OK. How many as relates to DU, depleted uranium?
    Dr. Feussner. I would say, again, probably six or seven.
    Mr. Shays. And how many involving vaccines?
    Dr. Feussner. I don't know the answer to that question. 
I'll have to get you those data.
    Mr. Shays. I know you will do that. I do want to ask the 
questions though. What yet unpublished studies are underway 
which would address the long-term effects of exposure to these 
toxic agents?
    Dr. Feussner. Well, there are quite a large number of 
projects that are still ongoing. For example, in PB, the total 
number of funded projects is about 30. With regard to chemical 
weapons, there are about 22. The DU focus at the moment in 
humans is pretty much limited to followup of the friendly fire 
soldiers in Baltimore, and there are a small number of probably 
four or five animal studies in DU.
    Mr. Shays. OK.
    Dr. Feussner. Did I answer all the parts?
    Mr. Shays. Well, it's a pretty extensive question. You said 
there are many. Do you think, in fact, there are many?
    Dr. Feussner. Yes.
    Mr. Shays. OK. And by ``many,'' you would give a number of 
what approximately?
    Dr. Feussner. For which issue?
    Mr. Shays. I just asked what yet unpublished studies are 
underway which address the long-term effects of exposure to 
these toxic agents which involve those four agents.
    Dr. Feussner. Yes, I could do the math real quick.
    Mr. Shays. Some you don't know. You said many. Are we 
talking 20, are we talking 80? I mean, what are we talking 
about?
    Dr. Feussner. In terms of total number of projects I think 
we're talking about in the ballpark of perhaps 100.
    Mr. Shays. And you will get back to us and document those?
    Dr. Feussner. You not only want the number of projects, you 
want the number of projects, those finished and the 
publication?
    Mr. Shays. Right.
    Dr. Feussner. Yes, sir, I'll have to get you that data.
    [The information referred to follows:]

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    Mr. Shays. I understand. According to a January 2000 
General Accounting Office report on Gulf war illnesses, the 
Department of Veterans Affairs stated that the research working 
group, which I'll refer to as RWG, would, ``establish a date in 
fiscal year 1999 or fiscal year 2000 for publishing its 
assessment of progress toward addressing the 21 research 
objectives that's identified in 1995.'' When will the research 
group assessment's of progress toward addressing the 21 
research objectives be published?
    Dr. Feussner. We've actually made a substantial progress in 
this area, Congressman. We discussed this at our last hearing, 
and the majority, 11 of the 15 papers that we had commissioned 
at that time are in draft form. We have worked with a very 
prestigious medical journal, and the editor of that journal to 
not only produce these papers for the Congress, but to produce 
these papers for the larger community. We have a commitment 
from----
    Mr. Shays. Isn't that the key? The larger community is 
complaining to us that they're not getting access to this 
research.
    Dr. Feussner. Yes, I think that is the issue.
    Mr. Shays. To date, we don't really have any published.
    Dr. Feussner. The papers have received preliminary review 
by the editor of the journal already, but the next step for the 
manuscripts will be to go out to independent experts to get an 
additional episode of review. I would hope that the manuscripts 
would be published electronically after the 1st of the year, 
perhaps the second quarter of fiscal year 2001. We have 
discussed with the editor the possibility of publishing the 
manuscripts electronically while we await for the manuscripts 
to appear in print. It is my hope that we can have the 
manuscripts in electronic format between January and March and 
in print as a special supplement, probably between March and 
May.
    Mr. Shays. So basically you're in fiscal year----
    Dr. Feussner. I am in fiscal year 2001.
    Mr. Shays. Right. You're really at the end of that fiscal 
year--well, it starts in September.
    Dr. Feussner. Yes.
    Mr. Shays. Not in the end. You're kind of in the middle. 
What is the research working group's role with the Military and 
Veterans Health Coordinating Board?
    Dr. Feussner. Well, the research working group, the 
Military and Veterans Health Coordinating Board has three 
subcomponents underneath the executive, the executive leader. 
The research is one of those three subgroups. Within the 
research group, there will really be two primary foci. The 
first will be the Gulf war research activities, since 60 
percent of these projects are incomplete. As a matter of fact, 
I think just in fiscal year 1999 and 2000, we have launched 42 
additional studies.
    The second component of the research activity within the 
military and veterans coordinating board will deal more 
specifically with the generic issue of post deployment health 
and three major, at least three major interests within that 
area will include an effort to improve the situation with 
regards to systematically obtaining baseline data so that after 
subsequent deployments, we will systematically have baseline 
data; systematically collect data through time on the soldiers 
which would also require an integration and a merging of the VA 
and DOD data bases; and then increasingly apply research 
activities or research results became available that could 
document exposures.
    Mr. Shays. To what extent will the absorption of the RWG 
into the new Military and Veterans' Health Coordinating Board 
diminish the RWG's focus on Gulf war illnesses, veterans 
illness research?
    Dr. Feussner. Well, it is my intent that it not diminish 
the focus on Gulf war veterans' illness, and given the 
incomplete status of the formal research and the emerging 
research that is going to be initiated with regards to post 
deployment health issues, I would imagine over the next period 
of time, say the next 3 or 4 years, that the dominant research 
effort within that larger group will continue to be Gulf war 
research projects.
    Mr. Shays. I'm going to try to finish because Mr. Sanders 
and I need to vote, but to what extent is the new board fully 
operational?
    Dr. Feussner. The new board has already engaged in a series 
of meetings several weeks ago. All leaders of the boards and a 
larger community of involved participants had a 2-day retreat 
at Andrews Air Force Base. We are completing the formal 
strategic planning process for the coordinating board and have 
identified the three leaders of the three major subgroups.
    Mr. Shays. So you haven't started being operational yet but 
you're at that point?
    Dr. Feussner. I think that's fair.
    Mr. Shays. According to a General Accounting Office, GAO, 
January 2000 report on Gulf war illnesses, questions remain 
regarding, ``how many veterans have unexplained symptoms and 
whether those who have received care in VA facilities are 
getting better or worse.'' What progress has been made toward 
developing a system of tracking clinical efforts and treatment 
outcomes among sick Gulf war veterans?
    Dr. Brown. I'll take a stab at that. We have a number of 
ways in which we track the health of Gulf war veterans. The 
Institute of Medicine recently released a report that I'm sure 
you're aware of which made the point that if we really want to 
study the long-term health consequences of service in the Gulf 
war, that is, your question whether veterans are getting better 
or worse are staying the same, that you need to set up 
appropriate longitudinal studies to follow those populations.
    We have a couple of studies already underway that are 
looking at subgroups of veterans. Dr. Feussner mentioned the 
Iowa study. I also want to make this committee aware, we just 
published a report just last April on a study that was looking 
at the health of all Gulf war veterans, called National 
Veterans Health Survey, looked at the health of all Gulf war 
veterans across the board. I can provide the committee with a 
copy of the report. It found similarly to other studies that 
when you look at a national survey of all Gulf war veterans, 
that you find greater rates of symptoms, greater rates of 
illnesses in terms of self-reported symptoms, and a number of 
other findings. It is unique in that it's the only study that 
looks across the board at all veterans, and it's our 
intention--it's my office's intention to follow that study up 
in a longitudinal sense.
    Mr. Shays. Basically though what I am hearing you say, we 
really don't have a system yet to track.
    Dr. Brown. I think we do have some initial data.
    Mr. Shays. You have data but you don't have a system, you 
are not tracking all these.
    Dr. Brown. The system that would do that for us would be a 
longitudinal study.
    Mr. Shays. ``Would be'' is not----
    Dr. Brown. We don't have that in place yet.
    Mr. Shays. This is all. And finally, what is the Department 
of Veterans Affairs doing about obtaining access to classified 
information? This really galls me that we don't have 
information. I mean we had the DOD who said our troops weren't 
exposed to offensive chemical exposure, and yet they were 
exposed to defensive chemical exposure. So I want to know what 
the VA's doing. Are we just lying back or are we trying to get 
this information?
    Dr. Feussner. In the research mode, we have not made 
efforts to get classified information. Two comments. The first 
is that my understanding is that the IOM will gain access at 
least to unpublished information about anthrax research in a 
new study that is being undertaken by them, and that with 
regard to CW, chemical weapons, issues that both the 
Presidential Advisory Commission and the Senate Veterans 
Affairs Investigating Committee had access to that classified 
information.
    Mr. Shays. The challenge we do have is the IOM did not have 
access to certain information.
    Dr. Feussner. That is correct.
    Mr. Shays. And I think it galls both me and Congressman 
Sanders that that's not made available, and it would strike me 
that anybody who's worked with our veterans would demand the 
same, so I just plead with you to be a little more aggressive. 
We will. We'd like you to be as well. I think what we'll do, I 
usually invite comments, if you have a 30 second comment either 
one of you, I'd welcome that, but we need to get voting. Any 
comment?
    Dr. Feussner. No, sir.
    Mr. Shays. Thank you both for being here.
    [Whereupon, at 12:05 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]

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