[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




                               before the


                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION


                           NOVEMBER 15, 2005


                           Serial No. 109-114


       Printed for the use of the Committee on Government Reform

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


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                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
JON C. PORTER, Nevada                C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas                BRIAN HIGGINS, New York
PATRICK T. McHENRY, North Carolina       Columbia
CHARLES W. DENT, Pennsylvania                    ------
VIRGINIA FOXX, North Carolina        BERNARD SANDERS, Vermont 
JEAN SCHMIDT, Ohio                       (Independent)
------ ------

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
                      Rob Borden, Parliamentarian
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

Subcommittee on National Security, Emerging Threats, and International 

                CHRISTOPHER SHAYS, Connecticut, Chairman
KENNY MARCHANT, Texas                DENNIS J. KUCINICH, Ohio
DAN BURTON, Indiana                  TOM LANTOS, California
JOHN M. McHUGH, New York             CAROLYN B. MALONEY, New York
TODD RUSSELL PLATTS, Pennsylvania    LINDA T. SANCHEZ, California
JOHN J. DUNCAN, Jr., Tennessee       C.A. DUTCH RUPPERSBERGER, Maryland
MICHAEL R. TURNER, Ohio              STEPHEN F. LYNCH, Massachusetts
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
CHARLES W. DENT, Pennsylvania

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
            Lawrence J. Halloran, Staff Director and Counsel
             Kristine Fiorentino, Professional Staff Member
                        Robert A. Briggs, Clerk
             Andrew Su, Minority Professional Staff Member

                            C O N T E N T S

Hearing held on November 15, 2005................................     1
Statement of:
    Mather, Susan, M.D., MPH, Chief Public Health and 
      Environmental Hazards Officer, U.S. Department of Veterans 
      Affairs, accompanied by Dr. Mark Brown, Director, 
      Environmental Agents Service, and Richard J. Hipolit, 
      Assistant General Counsel, U.S. Department of Veterans 
      Affairs; Dr. Lynn Goldman, Professor of Occupational and 
      Environmental Health, Department of Environmental Health 
      Sciences, Johns Hopkins Bloomberg School of Public Health, 
      Institute of Medicine; and Sam Potolicchio, M.D., Professor 
      of Neurology, Department of Neurology, the George 
      Washington University Medical Center, Institute of 
      Medicine, accompanied by Susanne Stoiber, Executive 
      Director, Institute of Medicine............................   235
        Goldman, Dr. Lynn........................................   255
        Mather, Susan............................................   235
        Potolicchio, Sam.........................................   275
    Woods, Mike, Gulf war veteran; Stephen L. Robinson, executive 
      director, National Gulf War Resource Center, Inc.; Jim 
      Binns, chairman, Research Advisory Committee on Gulf War 
      Veterans Illnesses; Dr. Rogene Henderson, senior scientist, 
      Lovelace Respiratory Research Institute; and Dr. James P. 
      O'Callaghan, member, Research Advisory Committee on Gulf 
      War Veterans Illnesses.....................................   141
        Binns, Jim...............................................   164
    Henderson, Dr. Rogene........................................   210
        O'Callaghan, Dr. James P.................................   215
        Robinson, Stephen L......................................   149
        Woods, Mike..............................................   141
Letters, statements, etc., submitted for the record by:
    Binns, Jim, chairman, Research Advisory Committee on Gulf War 
      Veterans Illnesses, prepared statement of..................   167
    Goldman, Dr. Lynn, Professor of Occupational and 
      Environmental Health, Department of Environmental Health 
      Sciences, Johns Hopkins Bloomberg School of Public Health, 
      Institute of Medicine, prepared statement of...............   258
    Henderson, Dr. Rogene, senior scientist, Lovelace Respiratory 
      Research Institute, prepared statement of..................   212
    Kucinich, Hon. Dennis J., a Representative in Congress from 
      the State of Ohio, prepared statement of...................     6
    Mather, Susan, M.D., MPH, Chief Public Health and 
      Environmental Hazards Officer, U.S. Department of Veterans 
      Affairs, prepared statement of.............................   240
    O'Callaghan, Dr. James P., member, Research Advisory 
      Committee on Gulf War Veterans Illnesses, prepared 
      statement of...............................................   217
    Potolicchio, Sam, M.D., Professor of Neurology, Department of 
      Neurology, the George Washington University Medical Center, 
      Institute of Medicine, prepared statement of...............   278
    Robinson, Stephen L., executive director, National Gulf War 
      Resource Center, Inc., prepared statement of...............   152
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut:
        Prepared statement of....................................     3
        Prepared statement of various individuals................    12
    Woods, Mike, Gulf war veteran, prepared statement of.........   144



                       TUESDAY, NOVEMBER 15, 2005

                  House of Representatives,
       Subcommittee on National Security, Emerging 
              Threats, and International Relations,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 1:03 p.m., in 
room 2154, Rayburn House Office Building, Hon. Christopher 
Shays (chairman of the subcommittee) presiding.
    Present: Representatives Shays, Dent, and Kucinich.
    Staff present: Lawrence Halloran, staff director and 
counsel; J. Vincent Chase, chief investigator; Kristine 
Fiorentino, professional staff member; Robert A. Briggs, clerk; 
Andrew Su, minority professional staff member; and Jean Gosa, 
minority assistant clerk.
    Mr. Shays. A quorum being present, the Subcommittee on 
National Security, Emerging Threats, and International 
Relations hearing entitled, ``Examining VA Implementation of 
the Persian Gulf War Veterans Act of 1998'' is called to order.
    Work by this subcommittee provided critical impetus for 
passage of the Persian Gulf War Veterans Act of 1998. That law 
directs the Department of Veterans Affairs [VA], to seek 
independent assessments of possible associations between toxic 
exposures and the unusual syndromes afflicting many ill 
    If a scientifically valid association is found, the VA may, 
by regulation, establish a presumption of service connection in 
favor of those applying for health and disability benefits. 
That process was intended to allow the VA to give sick veterans 
the benefit of the doubt until hard evidence of causality 
between the wartime exposures and chronic illnesses emerges 
from ongoing research. In the meantime, the law directs the VA 
to look to studies on animals to fill gaps in clinical and 
epidemiological data.
    Last year, a VA-sponsored review by the Institute of 
Medicine [IOM], on the effects of low-dose Sarin exposure 
raised questions whether the statutory mandate to use animal 
data is being followed. Former VA Secretary Anthony Principi 
specifically requested a reappraisal of earlier conclusions on 
Sarin exposure, based on the emergence of significant new 
studies showing the chronic brain function changes in animals 
after low-dose exposures. But the IOM committee reported animal 
studies play only a small role in their assessment.
    Not surprisingly, the expert committee, as before, found no 
connection between sub-clinical Sarin exposures and human 
illnesses. That conclusion epitomizes what many veterans see as 
a deeply entrenched reluctance in the VA and allied medical 
institutions to extrapolate from animal data on fundamental 
questions of disease causation.
    As the VA sees it, toxicology studies on rats and other 
animal data may be useful to probe the biologic plausibility of 
medical hypotheses; but only data from studies involving humans 
can be relied upon to determine a legitimate association 
between exposure and human disease.
    That sustained unwillingness to rely on animal studies 
thwarts a fundamental purpose of the statute: to ease the 
traditional burden of proof borne by veterans claiming service-
connected injury and disability. Whether motivated by a lack of 
scientific vision, or a fear of fiscal implications, the 
refusal to give greater sway to animal data in Persian Gulf War 
Veterans Act determinations undercuts the basic intent of the 
law to expand the scope of evidence upon which the VA may 
connect today's mysterious illnesses to wartime service a 
decade and a half ago.
    Those that the VA charge with implementation of the statute 
have to know the gold standard of human data on Sarin exposure 
they demand may never be available. Gulf war veterans don't 
know the dose to which they were exposed, and their fate should 
not hinge on the unthinkable prospect we will have more 
veterans who are terrorism victims to study.
    In terms of research protocols, it is unethical to 
intentionally expose human test subjects to lethal agents. So 
only data from animal studies will allow the VA to construct 
the links between exposure and ailments that sick veterans 
cannot. But, as we will hear from close observers of the 
process today, it appears VA has repeatedly attempted to 
minimize the role and impact of animal data in Gulf war 
    Ironically, another major scientific organization is moving 
in exactly the opposite direction. The Food and Drug 
Administration's Animal Efficacy Rule allows for approval of 
certain new drugs and biological products based solely on data 
from animal studies. So the experimental drugs and vaccines 
soldiers might be ordered to take against bioterrorism agents 
can be approved through unprecedented reliance on animal data; 
but determinations regarding the toxic causes of their 
subsequent illnesses still cannot.
    Our witnesses, all our witnesses, bring extraordinary 
commitment to the cause of helping veterans. And we appreciate 
their time and expertise, as the subcommittee continues to 
pursue these difficult issues.
    The Chair at this time would recognize the distinguished 
gentleman, the ranking member, Mr. Kucinich.
    [The prepared statement of Hon. Christopher Shays follows:]
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    Mr. Kucinich. Mr. Chairman, I want to thank you for holding 
this hearing. And I also want to thank you for your leadership 
on this issue.
    It has been 14 years since the end of the Persian Gulf war, 
and Congress is still holding hearings on the serious and 
persistent health problems suffered by one-third of the 
veterans who served in that conflict. Many of these problems 
have existed throughout the 14-year period; while others are 
just starting to appear.
    In fact, studies have shown that ALS, or Lou Gehrig's 
Disease, is twice as prevalent in veterans of that war, when 
compared to their non-deployed peers. While we now know that 
stress is not the cause, there is still much we do not know.
    I am happy to say that Mr. Shays, Mr. Sanders, and I were 
successful this year in our efforts to provide for funding for 
research into these Gulf war veterans' illnesses. The intent of 
our effort was not only to discover enough to prevent the 
offending exposures in the future, but also to make sure that 
those already exposed get the medical treatment they deserve.
    The more we know about the links between these illnesses 
and their exposures, the more likely the VA will give our 
soldiers an adequate disability rating for their exposure. But 
the VA continues to ignore a critical body of information that 
is going to be wasted as a result of their unwillingness to 
probe further.
    And I know it is harder to pinpoint causes and effects in 
human studies, because you cannot intentionally expose people 
to toxins; except of course in combat. And human 
epidemiological studies, that are a snapshot in time, are 
sometimes a problem, because you don't know if the exposure 
came before the disease.
    This is one of the reasons why we need to review data from 
all of the studies that have been done, to assess the toxicity 
of everyday products we buy and of the pharmaceuticals we take.
    I think that this hearing, therefore, is important, Mr. 
Chairman. I think you would agree that we owe our Nation's 
veterans a debt of gratitude for their service. We can do 
better, and we have to do better. Thank you, Mr. Chairman.
    [The prepared statement of Hon. Dennis J. Kucinich 





    Mr. Shays. I thank the gentleman. Let me use this 
opportunity ask unanimous consent that all Members of the 
subcommittee be permitted to place an opening statement in the 
record and that the record will remain open for 3 days for that 
purpose. And without objection, so ordered.
    I ask further unanimous consent that all witnesses be 
permitted to include their written statement in the record. And 
without objection, so ordered.
    Let me announce our witnesses. We have two panels. Our 
first panel is Mr. Mike Woods, Gulf war veteran; Mr. Steve 
Robinson, executive director, National Gulf War Resource 
Center; Mr. Jim Binns, chairman, Research Advisory Committee on 
Gulf War Veterans Illnesses; Dr. Rogene Henderson, senior 
scientist, Lovelace Respiratory Research Institute; Dr. James 
P. O'Callaghan, member of the Research Advisory Committee on 
Gulf War Veterans Illnesses. I would welcome them all to come, 
and I will swear them in.
    [Witnesses sworn.]
    Mr. Shays. Note for the record, all our witnesses have 
responded in the affirmative. Please be seated. Thank you.
    Before inviting Mr. Woods to speak first, I ask unanimous 
consent to place in the record 33 statements and letters 
submitted regarding the Persian Gulf War Veterans Act of 1998. 
And without objection, so ordered. The list includes the 33 
names, and we will submit it.
    [The information referred to follows:]
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    Mr. Shays. Thank you all very much. We have two panels, and 
I am going to ask you to stay as close to the 5-minutes as 
possible. I will let you run over a few minutes, but we would 
like to be as close to the 5 as possible. But don't read fast.
    All right, Mr Woods.


                    STATEMENT OF MIKE WOODS

    Mr. Woods. Thank you, Mr. Chairman and members of the 
subcommittee, for the opportunity to testify here this morning.
    Before I begin, I would like to dedicate my testimony to 
two warriors who are not here with us today. First, Navy 
Captain Michael Speicher, who has been missing since January 
1991, the start of the Gulf war, who is officially considered 
captured; second, Army Sergeant Matt Maupin, who went missing 
in April 2004, during the Iraq war.
    No matter how difficult our struggles as veterans may be, 
they in no way compare to what these two men must be enduring 
for our country. I will remember them, and I hope Congress and 
the American public will, too.
    In preparing my testimony for you today, I was forced to 
look back at many things that have happened with my health care 
since I returned home from the Gulf war in 1991. I considered 
writing a long drawn-out testimony of my very difficult 
experience with the VA. But with the limited amount of time we 
have here today, I will summarize my experiences.
    In looking back, many Gulf war veterans, including myself, 
first made contact with the VA through the VA Gulf War Registry 
exam process. You know how things went back then: VA denial of 
medical problems; long waits to see doctors, just to tell us to 
return in 15 or 20 years when science has time to catch up with 
our problems; or to simply be told there is nothing wrong.
    Since this time, veterans have organized. We have worked 
hard over many years with Congress to try to force the VA to 
recognize and treat our illness. We have met with reporters, 
held meetings, organized conferences. And we have even held 
long road marches across the country. We have worked close with 
veterans' groups to press for the enactment of the Persian Gulf 
War Veterans Act of 1998, sponsored by you and many members of 
this subcommittee.
    Now let me talk about VA failures after the enactment of 
the Persian Gulf Veterans Act. Years ago, I left the VA health 
care system, after being prescribed a powerful medication by 
the VA, ``Obecalp''--a medication to be used with extreme 
caution. However, it does not work very well. Spelled backward, 
it is simply ``Placebo.'' To answer your questions before you 
even start, I have never participated in a study; much less one 
at the VA.
    After leaving the VA and seeking private medical care, I 
found a good doctor and neurologist who managed to control my 
declining health. Thankfully, my wonderful wife, Jessica, has 
stuck with me over the years and has always ensured that I have 
received good medical care, even if we had trouble paying for 
    Recently, we sold our home in Florida, and moved back to 
our home State of Kentucky; at which time, I returned to the VA 
for my health care. My wife and I felt, after everything that 
has been done over the years, that surely the VA health care 
system has improved for Gulf war veterans. But to my surprise, 
returning to the VA was like going back in time.
    I was once again told there is nothing wrong with Gulf war 
veterans. Even worse, the doctor I saw on my last visit even 
stated that she cannot believe veterans receive compensation 
for Gulf war illnesses, because there is nothing really wrong 
with them that is related to their service. She even refused to 
fill prescriptions that have kept my illness from continuing to 
    I cannot believe, after all the work that has been done on 
this issue, that this is still the normal response from VA 
doctors. But when looking at their current training manual, it 
should not surprise any of us.
    In working with Undersecretary Jonathan Perlin, I know that 
he, for one, truly cares about ill Gulf war veterans. However, 
there seems to be a breakdown between his comments and what VA 
doctors do at VA hospitals and clinics. This is a breakdown 
that must be repaired. When looking at VA claims and how the 
process works, there is still much work to be done.
    After years of denials, I was finally able to convince the 
VA to approve my undiagnosed illness claim. This came about as 
a result of a roundtable discussion with Congressman Putnam of 
Florida, when I discussed with the VA Regional Director why 
veterans with clear evidence showing undiagnosed neurological 
disorders were being denied benefits by his VA rating officers. 
I went on to explain that the laws and regulations clearly show 
that they should be approved.
    He challenged me on this point, claiming that they properly 
review all cases by their merit; at which time, I produced a 
copy of a report done by my private doctor, who is a 
neurologist and psychologist, who clearly showed that I suffer 
from many neurological problems, to include motor nerve and 
sensory nerve neuropathy in all of my extremities, with the 
worst being in my right leg which now requires the use of a 
prosthetic brace to allow me to continue to walk.
    I also showed him reports from spinal taps done by the VA 
which show abnormal spinal fluid, that was reviewed by the 
Armed Forces Institute of Pathology, which they were unable to 
diagnose. This report does go on to say that the findings 
should be compared with clinical findings, to rule out such 
things as MS, ALS, and Parkinson's Disease, just to name a few. 
The Regional Director said he would have to get back to me on 
this. Several weeks later, I did not hear from him, but my 
claim was approved.
    While sitting before you today, I would like to urge you to 
consider the following recommendations: First, to extend the 
time a veteran has to file for presumption beyond the current 
10-year mark. As a result of VA doctors continuing to deny 
illnesses are associated with veterans' service, many veterans 
will continue to put off applying for benefits until it is 
their last option. In doing so, it will take them beyond the 
current 10-year mark, causing them to no longer be eligible for 
benefits they have earned and deserve.
    Second, grant service connection as a result of service for 
ALS, MS, and Parkinson's Disease, and other similar 
neurological disorders. Today's doctors are trained to diagnose 
illnesses. It is my fear that some veterans with very similar 
problems and the same test results as mine may have very well 
been diagnosed with a neurological disorder that looks and acts 
like something it is not; causing their claim to not be covered 
under current law.
    Require all VA doctors to be required to undergo training 
that reflects current science, not fiction from the past.
    Continue a comprehensive VA Registry exam. As veterans are 
returning from Iraq today, some are now reporting ill-defined 
symptoms, as well. My brother, Cole, is set to deploy to Iraq 
on December the 1st. I hope that he does not have to appear 
before you 15 years from now, to seek what he earns and 
    In closing, if those on the panel to follow us are not 
ready to admit that Gulf war veterans are ill because of our 
exposures, then allowing them to continue to decide research, 
treatment, and compensation will continue us down the same road 
we have been on for nearly 15 years. The first step to fixing 
any problem is to recognize the problem is real.
    Mr. Chairman, thank you for being one of our top advocates 
in Congress. You are a friend of veterans. You have listened, 
when others have turned their backs.
    [The prepared statement of Mr. Woods follows:]
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    Mr. Shays. Thank you, Mr. Woods. Part of that is that I 
sent you there. And when you send someone there, you would like 
to think that the Government is going to respond in kind.
    Mr. Robinson.


    Mr. Robinson. Thank you, Mr. Chairman. In the 1991 Gulf 
war, relatively few soldiers were injured from bullets and 
bombs; however, a significantly larger number of Gulf war 
veterans, who did not feel the sting of a bullet, have been 
suffering with, living with, and in some cases dying with 
illnesses that are absolutely connected to their wartime 
    This fact is confirmed in VA studies conducted by the VA 
and the Director of the VA Environmental Epidemiological 
Service. It is important to note that today, as we sit here, 
the Department of Defense and the VA are repeating some of the 
same errors from the 1991 Gulf war, by failing to collect and 
share data.
    Today, in this war, the VA does not know who has gone to 
war, how many of those released from the service are eligible 
for VA benefits, and what are the disease trends reported by 
the Department of Defense.
    In order to tell the subcommittee where we are today, we 
have to look a little bit at the past. In the 1995 report 
conducted by the Institute of Medicine entitled, ``Health 
Consequences of Service During the Persian Gulf War,'' the IOM 
concluded that research on Gulf war illness was fragmented and 
uncoordinated. The report suggested that serious efforts must 
be made in the near term to appropriately focus the medical, 
social, and research response of the Government and individuals 
and researchers.
    The IOM hit the nail squarely on the head in their first 
report. However, for the next 14 years, the VA spent a great 
deal of effort focusing their studies, but focusing them on 
stress, the thing that wasn't the problem in Gulf war veterans' 
    It is well known that a great deal of Federal money has 
been spent on a large number of Gulf war related studies since 
the mid 1990's--nearly $316 million, as of the VA's last report 
in 2003. This $316 million investment has produced no evidence 
that stress was the causal factor in Gulf war veterans' 
illness. Rather, it reinforced that the VA and DOD were looking 
in the wrong direction.
    Overall, Gulf war illness research money invested to date 
has not yet answered many key questions that scientists must 
address to make meaningful progress. No. 1, what are the 
specific physical processes underlying Gulf war illnesses; and 
No. 2, what treatments can improve veterans' health?
    Because of the lack of progress in addressing these 
diagnosed and undiagnosed conditions, President Bush, when 
elected, ultimately fulfilled a campaign promise to establish 
the Research Advisory Committee, and veterans were extremely 
happy when it was stood up.
    The Research Advisory Committee, by law, is the agency and 
the organization which advises Secretary Principi, and now 
Secretary Nicholson, on all Gulf war related issues, and is 
supposed to be privileged to all upcoming studies, future 
studies, and anything related to Gulf war veterans.
    The Research Committee issued its first interim report and, 
based on that recommendation, Secretary Principi promised $20 
million for Gulf war illness research. Historically, about 75 
percent of Gulf war veteran research came from DOD. However, 
since 2002, DOD has shifted its focus to the current war. This 
is why the $20 million promise by Secretary Principi was 
    Midway into that year, we learned that only one new study 
would be funded in fiscal year 2004, for fewer than $400,000. 
This amount fell far short of the $20 million for new research 
to provide answers to the long overdue questions.
    Overall, Federal Gulf war research funding has fallen 
dramatically, from $50 million in 2001, to $20 million in 2003. 
Final figures are not yet available for 2004 and 2005, but it 
appears that a downward trend has accelerated, at a time when 
medical progress in understanding and treating Gulf war 
veterans is greater than ever before.
    At this time, the VA is the only agency that funds new 
research on Gulf war illnesses. In late 2004, the VA Research 
Advisory Committee submitted the full report to the Secretary. 
In that report the committee reviewed government reports and 
literature which concluded that Gulf war illness constituted a 
serious health problem and, for the large majority of veterans, 
was not explained by stress or psychiatric illness.
    Secretary Principi released the report, and offered to 
commit $15 million of new research. This funding would include 
an innovative new program for identifying treatments for Gulf 
war veterans.
    Well, what has the VA done with that commitment? In 
September, we received information from the VA's 2005 research 
funding initiative that the VA Office of Research reported they 
would spend $9 million for Gulf war research in 2005, and a 
similar amount in 2006. But a closer look reveals that over $7 
million of the $9 million was for projects already in place, 
and up to $1.7 million funded new projects in fiscal year 
2005--far short of the $15 million.
    But worse, of the $1.7 million for projects identified as 
Gulf war research, $400,000 was for research specific to Gulf 
war veterans' illnesses, and the balance went to study ALS, a 
disease which has only affected about 100 Gulf war veterans.
    The VA has now identified that ALS is a serious problem, 
but it really affects elderly people. It has affected twice the 
rate for Gulf war veterans, but not in great numbers. 
Furthermore, of the new studies listed as Gulf war research, 
many have nothing at all to do with Gulf war illness.
    For example, $1.3 million was spent on a study restoring 
function after loss of limb. Including this and other unrelated 
projects in the total representative Gulf war research, this 
conveys a false impression that the VA is spending more and 
doing more to address Gulf war illness than is actually the 
    Another disappointment was that there was no funding in 
2005 for the much-needed, much-anticipated new study center for 
    There has been a consistent pattern, where the Secretary 
makes a commitment, and the veterans respond, but the VA does 
not deliver. The truth is, very little of the 2005 research 
funding was for new projects as promised by the Secretary, and 
very few of the new projects relate specifically to Gulf war 
    Ill Gulf war veterans are left pretty much where they 
started in 1995, with no improvements in understanding and 
nothing new on the research horizon. Entrenched bureaucrats 
under Secretary Nicholson have not upheld the research promises 
made by Secretary Principi. Secretary Nicholson must take 
charge of this issue, and direct his Office of Research and 
Development to spend the money promised.
    Veterans know that human studies of ALS, brain cancer, and 
neurological impairments are linked with their deployments in 
the Gulf war, and we are seeing higher rates of Multiple 
Sclerosis and Parkinson's Disease that need immediate 
investigation and research.
    The record shows that DOD and VA failed Gulf war veterans. 
We cannot allow this Nation or the VA to abandon the 1991 Gulf 
war veteran; nor should we pit their health care and research 
needs against returning veterans from this war. With the war 
escalating now in the Middle East, the United States has 
deployed more than 1.1 million soldiers, sailors, airmen, and 
Marines. And with great sorrow, I report to you that DOD and VA 
are not prepared for their return.
    Congress must order DOD and VA to collect data on these new 
war veterans and to fund the studies that they have promised 
for the 1991 Gulf war veterans. If we fail to act now, I 
believe another generation of veterans will be sitting before 
you in this subcommittee in a few years, demanding to know why 
veterans groups, Congress, and the administration failed them.
    Mr. Chairman, I know that we are short on time, so I will 
just ask that the rest of my information be submitted for the 
record. And thank you for allowing me to come testify here 
    [Note.--The GAO report entitled, ``Department of Veterans 
Affairs, Federal Gulf War Illness Research Stategy Needs 
Reassessment, GAO-04-767,'' may be found in subcommittee 
    [The prepared statement of Mr. Robinson follows:]
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    Mr. Shays. Thank you. I want to thank both Mr. Woods and 
you, Mr. Robinson, for very thoughtful presentations. Thank 
    Mr. Binns, thank you for your service as chairman of the 
Research Advisory Committee on Gulf War Veterans Illnesses. It 
is a privilege to have you here. And I want to make sure your 
statement is fully on the record. Thank you.

                     STATEMENT OF JIM BINNS

    Mr. Binns. Thank you, Mr. Chairman, members of the 
subcommittee. For nearly 4 years, I have had the privilege of 
chairing the Research Advisory Committee on Gulf War Veterans 
    In the same 1998 law that established the Research Advisory 
Committee, Congress directed the Department of Veterans Affairs 
to contract with the National Academy of Sciences. The 
Academy's Institute of Medicine [IOM], was to review the 
scientific literature regarding the substances to which troops 
were exposed in the Gulf, to determine if these substances are 
associated with an increased risk of illness.
    These reports were to be used by the Secretary of Veterans 
Affairs in determining whether an illness should be presumed 
service-connected, and thus trigger veterans' benefits.
    I regret to inform you that for 7 years, VA and IOM staff 
have subverted the will of Congress and misled the Secretary of 
Veterans Affairs regarding scientific research governing 
veterans' benefits.
    The law provided that the National Academy of Sciences 
shall determine whether a statistical association exists 
between exposure to the agent and the illness; the increased 
risk of the illness among human or animal populations exposed 
to the agent; and whether a plausible biological mechanism or 
other evidence of a causal relationship exists.
    Notice, please, that the statute speaks to the increased 
risk of the illness among human or animal populations. It is 
not just about human health effects and the implications of 
animal research on humans. It is equally concerned with animal 
health effects, per se. Congress recognized that research on 
the health effects of hazardous substances necessarily is 
conducted primarily in animals.
    The statute went on to provide that the Secretary of 
Veterans Affairs should consider animal studies in determining 
whether a presumption of service connection is warranted. He 
was to consider the exposure in humans or animals to an agent, 
and the occurrence of a diagnosed or undiagnosed illness in 
humans or animals.
    When the first IOM report was conducted under the law, 
however, animal studies were omitted from the standard for 
determining an association. The report states: ``For its 
evaluation and categorization of the degree of association 
between each exposure and a human health effect, however, the 
committee only used evidence from human studies.'' The authors 
of the report went on to say--and you will no doubt hear 
today--``But we did consider animal studies. We considered them 
for biological plausibility.''
    But under their methodology, biological plausibility does 
not even come into play unless there has been a previous 
finding of an association based exclusively on human studies.
    The salient fact is that they did not consider animal 
health effects in determining whether an association exists 
between an exposure and an illness, as required by law, and the 
only question that matters in the determination of benefits.
    To express conclusions as to whether an association exists, 
the authors set up five categories of association. Each 
substance was ranked according to these categories. The authors 
offered the following explanation of where the categories came 
from: ``The categories closely resemble those used by several 
IOM committees that evaluated herbicides used in Vietnam and 
other substances because they have gained wide acceptance for 
more than a decade by Congress, government agencies, 
researchers, and veteran groups.''
    It is revealing to compare a category of association used 
in the Vietnam studies with the same category used in the first 
Gulf war report, and all subsequent reports.
    Vietnam: ``Evidence is sufficient to conclude that there is 
a positive association. That is, a positive association has 
been observed between herbicides and the outcome in studies in 
which chance, bias, and confounding could be ruled out.''
    Gulf war: ``Evidence is sufficient to conclude that there 
is a positive association. That is, a positive association has 
been observed between an exposure to a specific agent and a 
health outcome in human studies in which chance, bias, and 
confounding could be ruled out.'' The Gulf war category does 
indeed closely resemble the Vietnam category. It tracks it 
almost precisely, with the exception of a single word. The word 
``human'' has been inserted in the Gulf war category.
    Like the earlier smokescreen regarding biological 
plausibility, this change was no accident. It was a deliberate 
act to subvert the intent of Congress. And it has been 
successful to this moment. It has been the straightjacket into 
which every IOM committee has been put when asked to review 
Gulf war research.
    The law also said that the IOM was to consider combinations 
of exposures; and they haven't. The law said they were supposed 
to consider undiagnosed illnesses; and they haven't.
    The most egregious example of this distortion involved 
recent animal studies on the nerve gas Sarin, which showed 
that, contrary to previous scientific belief, low-level 
exposures could produce long-term effects on the nervous and 
immune systems.
    Then, VA Secretary Principi wrote the Institute of 
Medicine, ``Recently a number of new studies have been 
published on the effects of Sarin on laboratory animals.'' He 
asked the IOM to report back on whether the research affected 
earlier IOM conclusions regarding ``the long-term health 
consequences of exposure to low levels of Sarin.''
    Last year, the IOM delivered its report. The report did not 
consider animal studies in the all-important categories of 
association, even though new animal studies were the only 
reason for doing the report. Not surprisingly, it found no 
evidence of association.
    This year, VA initiated three new IOM reports, which are 
underway at this moment. They were not reviewed by the Research 
Advisory Committee, as required by the 1998 statute. One 
purports to be a broad review of Gulf war illnesses literature: 
``An IOM committee will review, evaluate, and summarize the 
peer-reviewed scientific and medical literature to determine 
what this information taken together can tell us about the 
health status of Gulf War veterans.'' Again, however, the study 
design excludes animal studies.
    These distorted IOM reports are being used widely by the 
Department of Veterans Affairs. On September 15th, VA 
Undersecretary of Health, Dr. Jonathan Perlin, sent an 
information letter to VA doctors who treat Gulf war veterans. 
He assured the doctors that, ``A 2000 congressionally mandated 
review and a 2004 update conducted by the IOM concluded, based 
upon their review of a large body of scientific literature, 
that the evidence did not support any long-term health effects 
following sub-clinical Sarin exposure.''
    In summary, this fraud has gone on since 1998, and 
continues to go on. It has defied the will of Congress. It has 
distorted the workings of the Institute of Medicine. It has 
denied the Secretary of Veterans Affairs accurate information 
on which to determine veterans' benefits. It has misled 
veterans and their doctors. Most tragically, it has misdirected 
researchers down blind alleys and away from paths that might 
have led to treatments for these debilitating illnesses.
    Mr. Chairman, the Gulf war was the major military conflict 
of the United States in the last quarter of the 20th century; 
697,000 Americans served. According to the Department of 
Veterans Affairs' own most recent study, 25 percent of them are 
ill with chronic multi-symptom illnesses. That means that more 
Gulf veterans are ill than all the American troops in Iraq 
    But no one ever hears about it. No one knows about it. No 
one does anything about it.
    Why? Because of this. Because of the people who did this, 
and who are perpetuating it today; who undermine the 
Secretary's research commitments.
    I ask myself: What kind of country are we living in, where 
we send men and women to war, and government officials treat 
them like this when they return?
    Mr. Chairman, I urge Congress to use every power at its 
command to investigate this matter and ensure that the persons 
responsible are removed from positions of authority and 
punished. Until they are, there will be no meaningful progress 
on Gulf war illnesses research to improve the lives of ill 
    [The prepared statement of Mr. Binns follows:]
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    Mr. Shays. Nineteen years, and that is one of the more 
powerful statements I have ever had any witness deliver.
    Mr. Shays. Excuse me. This is a hearing and, I am sorry, 
applause is not allowed.
    Dr. Henderson.


    Dr. Henderson. Thank you, Mr. Chairman, for this 
opportunity to testify before the subcommittee. I am Dr. Rogene 
Henderson, a senior scientist emeritus at the Lovelace 
Respiratory Research Institute, an independent, not-for-profit 
research organization in Albuquerque, NM. I am a National 
Associate of the National Academies of Science.
    I am testifying today concerning the value of animal 
research in improving our ability to assess associations 
between exposure and health outcome in humans. In particular, 
for this hearing I am addressing the value of animal research 
in determining associations between exposures to noxious agents 
and health effects in Gulf war veterans.
    Because we are concerned about health problems in humans, 
one might question the need for animal research. Why not treat 
the conditions in humans symptomatically, as best we can? The 
answer is that in some situations, as with veterans returning 
from war, the symptoms may be diverse and difficult to 
    Animal research allows us to determine the mechanism by 
which the health problems occur. And this is done through 
conduct of controlled experiments that cannot be done in 
    If one knows the factors contributing to the development of 
the condition, one can then start to work on therapy or 
intervention techniques; and hopefully, prevent the same 
problems from occurring in the future.
    It is fair to ask whether animal responses correctly 
predict what would happen in humans. Animals have numerous 
anatomical, cellular, physiological, and biochemical 
similarities with humans. And we know a great deal about how to 
make allowances for known differences. Virtually every medical 
breakthrough in the past century has come about as the result 
of research with animals. These include vaccines for Polio, the 
use of Insulin to treat Diabetes, kidney dialysis, and cardiac 
bypass surgery, just to name a few.
    Animal studies are now being used to assess possible 
associations between symptoms of Gulf war veterans and 
exposures to noxious agents. For example, the effects of 
exposure to low levels of nerve gas agents that do not cause 
obvious neurological symptoms have been studied. We all know 
what high levels of a nerve gas will do. That kills us. But 
only recently have studies been completed to determine what low 
levels will do.
    In our laboratory, we found that low level, sub-clinical 
exposures of rats to the nerve gas Sarin suppresses the immune 
system and, in the presence of high temperatures, results in 
alterations in areas of the brain that are involved in 
cognitive function. Moreover, these sub-clinical doses of Sarin 
also affect the neuroendocrine function, and dramatically 
decrease serum cortisol levels. We are currently testing 
various therapeutic interventions for the treatment of these 
    Work by Dr. Abou-Donia, at Duke University, has shown that 
the combined treatment of rats with Sarin and the chemical used 
as a counter measure to Sarin, Pyridostigmine, causes death of 
neural cells. The rats recover, but suffer persistent memory 
and cognitive deficits. These symptoms are similar to those 
that were reported by some veterans returning from the Gulf 
war, and also in some survivors of the Japanese subway 
terrorist attacks.
    This line of animal research, which would be impossible to 
conduct in humans, is essential to provide information about 
potential health effects and approaches to treatment in 
veterans exposed under similar conditions.
    Animal studies are also being used to evaluate the risks to 
veterans from embedded depleted uranium. These studies include 
investigations to determine if the fragments can cause general 
toxicity, or induce cancer, or can partially dissolve and move 
to the brain or kidney and cause damage.
    This type of information has been used to guide the medical 
management of wounded Gulf war veterans. In any study on human 
health, information gained from human experience is the most 
useful. But when particularly puzzling health problems occur, 
animal studies are an excellent tool to help determine 
potential causes, effective therapeutic measures, and potential 
preventative measures.
    In the case of the Gulf war veterans, human information has 
been considered. The human data have not been adequate to fully 
explain the symptoms in the veterans, and animal research has 
been conducted that provides clues to clarify the situation.
    We are making good progress in determining the potential 
exposures that may be associated with the symptoms of the 
veterans. In determining these possible associations, we must 
consider the weight of evidence from all available sources of 
information, including human epidemiology studies, short-term 
clinical studies, and animal studies. It would be irresponsible 
to do otherwise. Thank you.
    [The prepared statement of Dr. Henderson follows:]
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    Mr. Shays. Thank you very much, Dr. Henderson.
    Dr. O'Callaghan. Let me ask you, you work for the CDC, 
    Dr. O'Callaghan. I do. I work for the Centers for Disease 
Control and Prevention, National Institute for Occupational 
Safety and Health.
    Mr. Shays. And does your statement have to go through a 
process of approval before you submit it?
    Dr. O'Callaghan. Yes, it does.
    Mr. Shays. Thank you. Dr. O'Callaghan.


    Dr. O'Callaghan. Mr. Chairman and members of the 
subcommittee, my name is James O'Callaghan. I head the 
Molecular Neurotoxicology Laboratory at the National Institute 
for Occupational Safety and Health, and I was recently 
appointed to serve on the Department of Veterans Affairs 
Research Advisory Committee on Gulf War Veterans' Illnesses. I 
am pleased to be here in my capacity as a member of the 
Advisory Committee to discuss the use of data from animal 
studies to diagnose and treat human brain disorders.
    Over the past 25 years, I have focused my research on 
detecting and characterizing the adverse effects of chemicals 
and drugs on the nervous system--research that includes the use 
of experimental animals to model human brain damage.
    In biomedical research, investigations using animal models 
are useful for understanding disease processes and for the 
development of relevant therapies for brain disorders that 
afflict humans. The use of animal models is useful in the 
neurosciences because, short of obtaining post-mortem brain 
samples at autopsy, there is no other way to discover and 
understand the basis of brain disorders.
    Moreover, while one might expect that brain disorders and 
brain damage may easily be detected in living humans using 
psychiatric and neurological examinations or even state-of-the-
art imaging, such is generally not the case.
    Think for a moment of the two devastating diseases of the 
human nervous system: Alzheimer's Disease and Parkinson's 
Disease. We can diagnose these distinct brain disorders in the 
living human, but these are progressive neurological diseases 
that result from underlying brain damage that starts decades 
    It is estimated that it takes the loss of 70 to 80 percent 
of the neurons affected in Parkinson's Disease before the onset 
of clinical symptoms can be detected. This means that one is 
suffering from the disease long before symptoms are evident. 
Thus, as neuroscientists, we are faced with the problem of 
having evidence of end-stage disease, without knowing the cause 
or even milestones of disease progression.
    This is where animal models are so useful. For example, 
genetically engineered mice and mice treated with selective 
neurotoxins now make it possible to replicate features of 
diseases such as Parkinson's and Alzheimer's in a controlled 
laboratory setting.
    These advances raise hope for a better understanding of the 
molecular basis of these debilitating diseases, and for the 
eventual introduction of therapies before symptoms become 
manifest and before the disease process has advanced.
    Such research and interventions are especially useful to 
NIOSH's work to enhance worker safety and health, since excess 
neurodegenerative disease, including Parkinson's and 
Alzheimer's, has been associated with a variety of occupations 
and workplace exposures.
    Although animal studies can be quite useful, they do have 
limitations. The major weakness of such studies is that 
biological differences between humans and animals may result in 
different responses to neurotoxins or medical interventions. So 
it is important to bear in mind that animal data are not always 
predictive of human responses.
    When available, scientifically sound epidemiological data--
data that are based on the study of the distribution and 
determinants of disease in human populations--are superior to 
animal data. However, in cases where information about human 
exposure is lacking, research in a controlled experimental 
setting, generally using animals, can provide useful scientific 
    Animal models not only hold promise for leading to cures 
for neurological diseases; they form the cornerstone for safety 
assessments, and have proven to have predictive validity for 
setting margins of safety for potential adverse effects of 
drugs, including adverse effects on the nervous system.
    Animal data have been used to help establish the margins of 
safety to protect humans from drug-induced toxicity, to set 
pesticide exposure limits, and to determine if specific agents 
or mixtures have the potential for adverse long-term outcomes.
    As the relationship between chronic, low-level exposures 
and adverse neurological outcomes has become better understood, 
the Department of Veterans Affairs and the U.S. Army have 
established animal research programs to further our 
understanding of the relationship between chemical exposures 
and neurodegenerative diseases.
    The long-term goals of these programs are to relate short- 
and long-term exposures to specific chemical agents and 
mixtures to the development of brain disorders, and to develop 
specific neuroprotective agents and strategies to protect 
against the development of nervous system disorders.
    In summary, animal studies have been, and will continue to 
be, of great importance in establishing a predictive 
relationship between specific exposures in humans and 
subsequent adverse effects on the nervous system.
    Again, thank you for the opportunity to testify before you 
today. I will be happy to answer any questions.
    [The prepared statement of Dr. O'Callaghan follows:]
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    Mr. Shays. Thank you very much, Dr. O'Callaghan. Let me 
start out with you, Dr. O'Callaghan, and ask you--and I want 
you to listen to how I am asking the question--separating Mr. 
Binns' points about people being held accountable for what has 
happened in the VA in its ignoring, in my judgment, the law, is 
there anything that you disagree with Mr. Binns on in his 
    In other words, setting aside--I would not ask you, as 
someone working for the Government, to suggest that people be 
fired and so on. I want to know, though, do you disagree with 
his analysis that the law has not been followed?
    Dr. O'Callaghan. Mr. Chairman, I doubt if I could 
adequately respond to any question relating to legal 
responsibilities. But I would agree wholeheartedly with Mr. 
Binns' suggestion that animal models of long-term neurological 
effects, as part of the law that was in place, have not 
particularly been adequately followed at this point in time.
    But that is based on the fact that in studies that rely 
solely on human data and not on experimental animal data, those 
would not be complete studies to reveal the broad class of 
effects that you would see relationship to long-term, low-level 
exposures to agents, such as Dr. Henderson has already talked 
to us about today.
    Mr. Shays. Dr. Henderson, I am going to ask you the same 
    Dr. Henderson. Well, I would like to say, as I said in my 
testimony, we are beginning to make great progress on this 
problem. And it would be foolish, irresponsible, I think, not 
to take into account the progress that is being made using 
animal models on the effects, particularly of some of the nerve 
agents such as Sarin; because we are just beginning to find out 
    Mr. Shays. Yes, and who funds your projects?
    Dr. Henderson. Who funds my projects? The first study we 
did was from the Gulf war, DOD and the Gulf War Syndrome. And 
now DOD has funded our latest studies, and we are applying for 
NIH funding now.
    Mr. Shays. Have you asked for any funding through the VA?
    Dr. Henderson. No, we have talked. I didn't think they had 
the money to fund it, so we haven't pursued that.
    Mr. Shays. Mr. Woods, I am going to ask you the same 
    Mr. Woods. I would just answer it simply, that I agree 100 
percent with Jim Binns that they are failing to obey the law.
    Mr. Shays. Mr. Robinson.
    Mr. Robinson. We spoke about this this morning, whether or 
not it rose to the level of actually having a special 
prosecutor look at whether or not the intent of the law was 
    I am not a lawyer; neither is Mr. Woods. But we believe the 
law has been violated. Clearly, the intent of the law has been 
violated. And it has been steered down a road which has harmed 
individuals and created delay. So, yes, sir, we believe that it 
is a very serious, very serious charge.
    Mr. Shays. OK. Dr. Henderson and Dr. O'Callaghan, 
addressing the point of, ``Evidence is sufficient to conclude 
that there is a positive association; that is, a positive 
association has been observed between herbicides and the 
outcome in studies in which chances, bias, and confounding 
could be ruled out;'' and then the Gulf war, ``Evidence is 
sufficient to conclude that there is a positive association; 
that is, a positive association has been observed between an 
exposure to a specific agent and a health outcome in human 
studies in which chance, bias, and confounding could be ruled 
out''--tell me the significance of those two different 
perspectives, Vietnam and the Gulf war. I will start with you, 
Dr. O'Callaghan.
    Dr. O'Callaghan. They should be the same, and addressing 
these problems with animal models and epidemiological data 
should be applied across both.
    Mr. Shays. And it isn't, based on that definition?
    Dr. O'Callaghan. Not necessarily, no.
    Mr. Shays. And explain why.
    Dr. O'Callaghan. Because one takes out ``animals,'' and one 
does not.
    Mr. Shays. Which takes out ``animals?''
    Dr. O'Callaghan. The Gulf war.
    Mr. Shays. Thank you. Dr. Henderson.
    Dr. Henderson. Well, I think it is essential to make use of 
animal research in both instances; though the way it is 
written, you wouldn't take them into account in the Gulf war.
    Mr. Shays. So let me just say it again. The way it is 
written, you wouldn't take it in what? Finish your sentence 
again, please.
    Dr. Henderson. The way it is written, you would assume they 
weren't taking into account animal studies.
    Mr. Shays. In the Gulf war?
    Dr. Henderson. In the Gulf war, no. And I said that I don't 
see any point in tying one hand behind your back. Why not use 
the information? And it is of such great value. You need it in 
this case, because it is not clear from the human data.
    Mr. Shays. Now, in my statement I made reference, and I 
think there was reference by some of your statements, to the 
fact that the FDA, in approving drugs, looks at animal studies. 
And in the case here, it doesn't. Does that sound to you--in 
other words, to affirm and to allow the drug to be used, they 
will look at animal studies. Is that correct, Dr. O'Callaghan?
    Dr. O'Callaghan. Yes.
    Mr. Shays. Is that correct, Dr. Henderson?
    Dr. Henderson. Yes.
    Mr. Shays. In the case of Gulf war illnesses, it appears 
they do not. Explain to me, give me your best argument, both of 
you, as to, in spite of the fact that the law requires it--but 
if I take Mr. Binns' comments in every aspect except to suggest 
that someone be removed from office and prosecuted, if I take 
that out, give me the best argument why the bureaucracy would 
be so reluctant to look at animal studies. The best argument.
    In other words, I am asking you to say what is their best 
argument. What is the best logical argument?
    Dr. O'Callaghan. Well, to play devil's advocate, the only 
thing you could say is that you had such solid data in hand 
from human exposures that would be predictive, and you would 
understand the basis for the disorder; which of course, we 
don't have that data.
    Mr. Shays. And why don't we have that data?
    Dr. O'Callaghan. Because the exposures are too difficult to 
determine. And the multiple agents and the constellation of 
effects are so difficult to assess only under human 
epidemiological conditions that we need animal models, to study 
that for a long-term basis.
    Mr. Shays. Dr. Henderson, would you add anything to that?
    Dr. Henderson. Well, I think you are asking me to read 
someone else's mind, I mean, to say what is in their----
    Mr. Shays. No, I don't care if you read someone else's 
mind. I want you to tell me what the best argument could be for 
not using animal data. You don't have to be in anybody's mind. 
Give me the best reason.
    I think, after you give me your answer, you will understand 
why I have asked the question. So give me the best reason. You 
are advising the VA not to use animal studies. Tell me your 
best scientific reason for not using them.
    Dr. Henderson. Boy, that is troublesome. You are talking to 
someone who has spent their life in animal research and seen 
the value of it. So you are asking me to go against my----
    Mr. Shays. But you must have heard the arguments.
    Dr. Henderson. Well, it is money, I guess.
    Mr. Shays. What is it?
    Dr. Henderson. It may be that they are concerned about 
    Mr. Shays. I am not asking you for motives. You have 
requested that I not ask for motives. Give me the best argument 
for not doing it. It may not be a good argument, but give me 
the best argument.
    Dr. Henderson. Animals are not humans, and we only care 
about humans.
    Mr. Shays. OK. Mr. Binns, a little reluctant to--I want you 
to remove your anger--that I share--that the VA has not lived 
by the law, and give me the best argument on why you would not 
use animal studies.
    Mr. Binns. I don't think there is a good argument. But the 
argument that has been made, both in the reports and I saw it 
today in the paper, is the one that Dr. Henderson mentions: 
that humans are not animals, and therefore we have to limit our 
use of animal data.
    And we don't know what the dosage levels were in the Gulf, 
and therefore we can only consider a conclusion as to humans if 
we knew the dosage level. But of course, they will never know 
the dosage levels, and they know that.
    Mr. Shays. This subcommittee has held 14 hearings in the 
course of our work on this issue. And it is clear there are a 
lot of things we don't know. I mean, it is clear there are a 
lot of things we do know.
    Most soldiers acted like I acted the first time I decided 
to put fertilizer on my lawn. I thought if I did it according 
to the directions, I would set my Scott spreader at three-and-
a-half. That was what they said would produce results. I used 
my distorted logic and said, ``Well, if this is so good, double 
is better.'' So I set it at six. I ended up with a burnt lawn.
    We had witness after witness in the course of 14 hearings 
that, when the alarms went off, they took PB, Pyridostigmine 
Bromide--and it took me more than 10 years to be able to say 
that word--and they just took them all, all at once. You made 
reference, I think, Dr. O'Callaghan--or did you, Dr. 
Henderson--to the mixing of PB and Sarin.
    Dr. Henderson. Yes.
    Mr. Shays. And what was the finding that you made?
    Dr. Henderson. This is work of Dr. Abou-Donia, and he found 
that the combined exposures were more deleterious than either 
one alone. So both of those compounds act at the same reactive 
    Mr. Shays. Describe to me again the outcome.
    Dr. Henderson. They have a death of neural cells, and there 
is a memory deficit that is persistent after the--and this is 
in rats. A memory and cognitive function deficit occurs in the 
    Mr. Shays. Dr. O'Callaghan, could you add anything to that?
    Dr. O'Callaghan. At least when you look at short- or long-
term toxic effects of compounds, often what you see in humans 
as well as animals is that you can get aggregate, or 
synergistic, toxicity when multiple agents are put together. So 
you need to study those types of events and those types of 
exposures in a very controlled setting, to get a reliable 
outcome that would be predictive of human data.
    So what Dr. Henderson has said is that this is a double 
exposure that gave effects that the single ones alone may not 
have. So this is another reason to use the animal models, to 
study these effects.
    Mr. Shays. And didn't you, Dr. Henderson, say that your 
immune system is impacted?
    Dr. Henderson. Oh, very definitely. And this was a surprise 
to us. That is why it is so interesting. We didn't know what 
low levels would do. But it has a drastic suppression of the 
immune system.
    Mr. Shays. Did you say ``drastic?''
    Dr. Henderson. Yes.
    Mr. Shays. So low levels in animals had a drastic what?
    Dr. Henderson. Effect on the immune system. And of course, 
this means, if this happens in humans, veterans would be more 
susceptible to infectious agents, etc.
    Mr. Shays. Right.
    Dr. Henderson. So we are still working on the mechanism by 
which this happens. And we are hoping to get some ideas for 
intervention or treatment.
    Mr. Shays. Mr. Binns, in your dealing with the VA--and DOD 
as well--but in your dealing with the VA, does the VA or DOD 
deny that veterans are sick, but just can't determine their 
cause--excuse me. Do they accept the veterans are sick, but 
feel they can't determine the cause of the sickness? Or do they 
even deny the veterans are sick?
    Mr. Binns. They accept that the veterans are sick, but 
there is a disconnect between what they say as to the magnitude 
of the problem. On the one hand, they will stress studies 
showing that there are small numbers of veterans who are ill 
with various diagnosed illnesses--standard, off-the-shelf 
illnesses that people are used to.
    On the other hand, at our last committee meeting we heard 
testimony from Dr. Han Kang of the VA, on his most recent study 
of Gulf war veterans which found that in excess of 25 percent 
of Gulf war veterans are ill with chronic, multi-symptom 
illnesses that don't fit into these neat categories.
    So their own research does confirm that large numbers--a 
quarter or more--are ill. But they act as if it's only the 
diagnosed illnesses, which may be a much lower percentage.
    Mr. Shays. Now, you talked, Dr. Henderson, about motives. 
And I wrestle with that issue tremendously, because there is no 
question--we documented it 100 different ways--that veterans 
are sick. I do agree the VA believes the veterans are sick. I 
do believe the DOD believes veterans are sick, but is even less 
interested than the VA in wanting to deal with this issue.
    So, you know, then I get to motives. And while you can't 
speculate about motives, I can, and I do. And we are going to 
ultimately sort it out. One could be a fiscal issue. They have 
looked at ALS, and they said, ``Yes, we are going to make a 
presumption there.'' My sense is it is because it is only 100, 
and it is such a devastating disease; so it made the list.
    But as you start to look at some of these others, then the 
number expands significantly. So I think fiscal is a 
    I also think that in these studies there is concern about 
the use of uranium in the shells and in the protection on the 
equipment, and the view that this may be a factor. If your 
animal studies point that out, it has significant impact on how 
we think about the weapons systems and the protections that we 
provide our soldiers. So that is another area.
    The other one is that the VA, in the course of our 
hearings, has very few people who work for it who deal with 
hazardous material in the workplace. And so I find myself being 
more tolerant because all the folks--there are very few people 
that have an expertise in this area: chemicals, the impact of 
chemicals on the body, and so on, in the workplace.
    We found that of the thousands of people who work for the 
VA, they could only name us two people of the doctors, they 
could only name us two who had any expertise. So when veterans 
came in, they didn't have people who would intuitively say, 
``You know, we have seen this in the workplace.''
    So Mr. Binns, I am going to have my staff person ask 
questions in a second, but did you want to make a response?
    Mr. Binns. Yes. It is true that Secretary Principi 
authorized benefits for veterans with ALS. But in fact, that 
has not been service-connected as an across-the-board finding. 
The VA at the moment has no presumed service-connected 
illnesses for Gulf war illness.
    Mr. Shays. Say that again?
    Mr. Binns. The VA has no illness which is currently 
service-connected automatically under a presumption.
    Mr. Shays. So explain to me how they cover ALS.
    Mr. Binns. They covered ALS for the subjects who came 
through. And I do not know what has happened to people who have 
contracted ALS since. But it was done on a case-by-case basis.
    Mr. Shays. Yes, Mr. Robinson.
    Mr. Robinson. The Secretary has the authority--it is kind 
of like a magic wand--to pick out a particular group and say 
for those people, ``We will take care of them. We will pay them 
benefits. It's a very debilitating disease.'' But it was not 
codified into law as a presumptive service connection; much 
like the finding for brain cancer will most likely not be 
codified into law as a presumptive service connection.
    And if I might add, you have been talking about motive. The 
clearest motive to me that there is a problem is this document 
right here, which educates VA clinicians. It is so full of 
inaccurate, old, no longer recognized scientific information.
    Mr. Shays. And what is that document?
    Mr. Robinson. This is called the ``Veterans Health 
Initiative: A Guide to Gulf War Veterans' Health.''
    Mr. Shays. Is there a date on it?
    Mr. Robinson. It was originally written in 2002, I believe, 
which is what is written on it. And the findings are, ``Most 
Gulf War veterans have health problems similar to those 
experienced by veterans of other eras;'' which is patently 
false, including the VA's own admission from their study which 
indicates that is not true.
    Another section says, ``Panels have been unable to identify 
a unique Gulf War Syndrome or find any specific war-time 
exposure to be a significant cause of illness amongst 
veterans.'' This is the information that the clinicians are 
reading, and the reason why, when Mike Woods walks into the VA 
in Kentucky, his doctor tells him, ``I don't know why you're 
here. Gulf war veterans aren't sick, and you don't deserve 
    This is intent. Nowhere else in the military, in the DOD, 
or in Congress, can you put out a document like this, and not 
keep it current, and not be telegraphing your intent.
    The VA has not kept up, or even consulted with or promoted, 
the information that the Research Advisory Committee was stood 
up to look at. It is not in this document. It is very rarely 
talked about. I think it screams intent. And it is something we 
would like to get changed.
    Mr. Shays. Mr. Binns.
    Mr. Binns. One further comment about ALS. One of the three 
new studies that the VA initiated this spring with the IOM 
relates to ALS. There are only three studies in the literature 
pertaining to ALS and military service, so it is quite 
extraordinary to ask for an IOM committee to be stood up for 
the purpose of examining three studies.
    Mr. Shays. I missed that point, I'm sorry. Hit me again 
with that.
    Mr. Binns. Usually, the IOM is brought into play when there 
is a very large body of scientific literature to review; such 
as in the case of exposures to pesticides or something like 
that. So it is a red flag to see that the VA has asked IOM to 
review the literature on ALS and Gulf war or other military 
service. And it is not something that would usually be done. It 
is not something which Congress mandated be done.
    And the evidence is suggestive that the motives are not 
good; that the finding is going to be that this is something 
which we don't know enough about yet, and therefore we 
shouldn't have ``service-connected.''
    Mr. Shays. I am going to ask Counsel to ask some questions, 
and then I am going to come back for a few more.
    Mr. Halloran. Thank you. Mr. Woods, in your testimony, you 
said you underwent a VA Registry exam after your service. Were 
you asked at that time, or at any time since then, about 
potential exposures, toxic exposures?
    Mr. Woods. No.
    Mr. Halloran. Did you volunteer the information?
    Mr. Woods. They didn't ask.
    Mr. Halloran. They didn't ask.
    Mr. Woods. I don't think they wanted to hear.
    Mr. Halloran. In our testimony, you also said, though, that 
you did manage finally to get a claim through, based on your 
illnesses. Would you describe briefly that process and its 
outcome? What is the basis of the claim, and how did you prove 
    Mr. Woods. In my testimony, I cited that I had been seeing 
a neurologist, who is also a psychologist, and he did a 
multitude of neurological tests. And I submitted those, as well 
as the VA's neurological tests that found the exact same 
findings as my private neurologist. And they were unable to 
diagnose the reason, the basis, for the signs and symptoms that 
they found in a neurological nature. And the claim was approved 
as an undiagnosed illness claim.
    Mr. Halloran. Mr. Robinson, is that your experience, more 
broadly, with Gulf war veterans in the disability system?
    Mr. Robinson. I would just like to add one thing, because I 
am very connected with Mike's case. It is that it should not 
take a congressional representative's interaction to get a VA 
claim approved. And the reason that his VA claim rose from 
where it was to importance in the VA is because Congressman 
Putnam said, ``Well, here is his evidence. Let's prove it.'' 
And it shouldn't take that.
    My experience is that VA doctors don't know what the 
current science says today. They probably don't know, if we 
walked into--you pick it--VA anywhere in the United States and 
said, ``Tell me about the findings of the Presidentially 
directed, VA-appointed Research Advisory Committee,'' they 
would not know what you were talking about. That is the first 
    The second problem is adjudicators do not follow the law. 
And the undiagnosed illness law has been particularly harmful, 
because they have identified, basically, three diagnoses within 
the undiagnosed law that you can--if you get CFS, MCS, or 
irritable bowel syndrome, then you have undiagnosed illnesses. 
But you have to get the diagnosis of CFS to get undiagnosed 
illnesses. It is particularly harmful to veterans. It is 
confusing. The adjudicators don't know how to do it.
    It is my experience that the first thing is, if you don't 
look, you don't find; if you don't educate the doctors, then 
they won't know how to diagnose; and if the adjudicators aren't 
trained properly and familiar with what the law says they are 
supposed to do, then the veterans' claims won't be approved.
    Mr. Halloran. Mr. Binns, back to the three pending IOM 
studies, your testimony says that, as you read the law, those 
studies should have been passed by the Research Advisory 
Committee before being submitted to the IOM. Did you raise that 
issue with VA, and what was their answer?
    Mr. Binns. Yes, when we learned of the studies, I did bring 
it to the attention of Secretary Nicholson. Secretary Nicholson 
had been in office about 2 months at that time. I was shown a 
memo from Undersecretary Perlin objecting to my objection. No 
action has been taken to review the appropriateness of the 
actions that have been started by VA.
    Mr. Shays. Do you have a copy of that memo?
    Mr. Binns. No.
    Mr. Shays. I would like to direct the subcommittee to get a 
copy of that.
    Mr. Halloran. With that as background, describe, if you 
would, more broadly the committee's relationship with VA over 
the course of your service there. I mean, when was the first 
time you noticed this particular problem, and what was their 
response to that?
    Mr. Binns. This has been raised over 6 months ago. We 
actually, last year when the updated study on Sarin was 
presented, observed that it seemed bizarre that when the study 
was initiated solely because of new animal studies, animal 
studies were not taken into account in the basic conclusions.
    But it was just after these new IOM studies were begun this 
spring that we read the law carefully and learned that, indeed, 
by law, animal studies were to be weighed with the same 
evidence as human studies.
    Our broader relationship with VA's research office has been 
one of--I'd say initially, we were kept at arm's-length as much 
as possible. We were----
    Mr. Shays. Excuse me, arm's-length between whom?
    Mr. Binns. Between the Research Advisory Committee and the 
Office of Research and Development. In the fall of 2002, for 
example, a new deployment health initiative was published by 
VA. We were never consulted prior to this initiative being put 
out, even though it clearly is a proposed plan within the plain 
meaning of the statute.
    Then, with the appointment of Dr. Wray, who was briefly the 
chief research and development officer, we were more involved, 
in the sense that she actually came to our meetings; she paid 
attention to our work. And she was only in office for about 1 
    Then, in 2004, as Steve just mentioned, we discovered 
halfway through the year that the VA, rather than planning up 
to $20 million in research, had planned for $400,000 in 
research. We brought that to the attention of Secretary 
Principi. He froze the VA research budget at that moment. And 
at that point in time, we began to get much higher levels of 
    And if you remember the last time I appeared before you, in 
June 2004, we appeared to be on a true turnaround at VA, where 
a plan had been agreed upon, Dr. Perlin was involved in 
preparing it----
    Mr. Shays. Let me just be clear. That was still under 
Secretary Principi?
    Mr. Binns. Yes, it was. And so, unfortunately, shortly 
thereafter, a new Acting Chief Research and Development 
Officer, Dr. Finn, took office, and we began to see that plan 
fall apart. And in November----
    Mr. Shays. Again, who was the individual when you saw the 
plan fall apart?
    Mr. Binns. Dr. Steven Finn. He was the acting chief 
research and development officer for about 1 year.
    In November, Secretary Principi announced the plan, as 
Steve mentioned, to do up to $15 million of new research in 
fiscal year 2005. As of--well, we were just recently given a 
report showing what the VA claimed to have funded in research 
in 2005. And as Steve said, while the total is $9 million, if 
you take out projects funded in previous years and ongoing 
projects, the total is only a few hundred thousand dollars at 
    Mr. Shays. Let me be clear. You are saying that the studies 
that were done in 2005 were just a continuation of projects 
begun earlier?
    Mr. Binns. Yes. In some cases, they were new studies, but 
they were studies which had actually been done under the 2004 
initiative. And oddly enough, while VA takes credit for these 
as being evidence of new studies that are started, half of 
those studies related to stress. And they were the studies that 
caused Secretary Principi last November to say, ``We are not 
going to fund stress on fiscal year 2005 studies.'' So to see 
them using those studies to take credit for what they did in 
fiscal year 2005 is extraordinary.
    I should add that there is a new chief research officer, 
Dr. Coopersmith. And he has launched some--he has actually got 
a copy of the treatment development program that is ready to 
go. But we have seen them get to first base many times before.
    This cycle varies depending upon, frankly, how many times 
Ross Perot calls the Secretary of Veterans Affairs. And if he 
hasn't called for a while, they seem to forget us, and they 
seem to forget Gulf war illness research. When he calls, then 
suddenly they become interested again.
    So had this new effort by Dr. Coopersmith begun 3 years 
ago, I would be much more convinced that it represented a 
change in attitude. At this point in time, I have seen it too 
many times. Until there are actual results to report that make 
a difference, I don't believe these guys any more.
    Mr. Shays. Have you been reappointed to this position?
    Mr. Binns. My term is up in January.
    Mr. Shays. Are you term-limited? Could you be reappointed 
    Mr. Binns. Legally, I could be reappointed.
    Mr. Halloran. Thank you. Drs. Henderson and O'Callaghan, 
attached to Mr. Binns' testimony--I don't know if you have seen 
it--but there is a list of the animal studies conducted in this 
realm from 1976 to, I think it is about 2004, including some of 
your work Dr. Henderson. And much of this is the body of work 
that Secretary Principi asked the IOM to review, to see what 
impact it might have on their earlier findings regarding Sarin 
    Help us understand what besides biologic plausibility, what 
other elements of missing epidemiological data can these animal 
studies help inform?
    Dr. Henderson. Well, it defines the exposure level that was 
required to cause these effects.
    Mr. Halloran. And can that be extrapolated to humans? I 
mean, mice are little things.
    Dr. Henderson. You could do some modeling and try to 
extrapolate to humans. The missing information, of course, is 
what the humans were exposed to. So it indicates that you 
should look at the potential exposures to low levels of Sarin 
as a potential cause for some of these effects, and that is a 
plausibility. But it opens the way for a lot of new research on 
how you could do therapy, how you could do interdiction 
techniques, etc.
    Mr. Halloran. But in terms of what you understand about the 
IOM project--have you ever sat on an IOM committee?
    Dr. Henderson. Yes, I have. Two.
    Mr. Halloran. Oh, OK. So in terms of the process they are 
undergoing, in terms of these categories of association----
    Dr. Henderson. Yes.
    Mr. Halloran [continuing]. Is it, to use your word, 
irresponsible or bad science to use animal data to inform your 
conclusions about a factor other than biological plausibility?
    Dr. Henderson. Well, I think, of course----
    Mr. Halloran. That is where they seem to park it, and so I 
am just asking.
    Dr. Henderson. Yes, I see what you are asking. It does 
contribute to the plausibility question. But it would also help 
with the dose/response information, which is a step further 
down the road. How much of this is required?
    It also helps with the, you know, persistence and answering 
questions. Is this something that persists, or is it something 
that goes away very quickly?
    But I think the dose/response information is probably the 
fundamental new information you get from those studies.
    Dr. O'Callaghan. Just generally, I would say we are living 
in an era of unprecedented advances in the neurosciences. And 
these advances are predicated in large measure on basic 
mechanistic work done in laboratory animals. And in a 
toxicological context, as Dr. Henderson already said, setting 
dose, setting dosing regimens for long-term exposures, and then 
looking for the most sensitive indicators of underlying effects 
that are adverse--for example, on the nervous system--are 
examples of what you can do in animal models, and why you would 
include those data.
    Animal models are not always predictive, however, of the 
human condition. But you are interested in the broadest net 
being cast to get the answer to the problem.
    Dr. Henderson. There is one more thing that I was thinking. 
In our studies, we found this lowering of serum cortisol levels 
is quite interesting as a potential biomarker of exposure that 
might be used in the field. In other words, if people came in, 
you could--you know, seeing this, you might associate it with 
exposure to nerve gases. We are still working on that, whether 
that is possible.
    Mr. Halloran. If that is the case, lower cortisol levels, 
is that like a blood test, or is that a 36-hour PCR process?
    Dr. Henderson. Well, I am not sure I understood your 
    Mr. Halloran. If lower cortisol levels were to be a 
biomarker for exposure----
    Dr. Henderson. Yes.
    Mr. Halloran [continuing]. Is the lower cortisol level 
easily detected? Or is it something you won't know for 36 or 48 
hours or more, once we take blood or whatever we have to do?
    Dr. Henderson. I think those are details that we would have 
to work out.
    Mr. Halloran. You don't know.
    Dr. Henderson. We don't know the answer to that.
    Mr. Shays. Dr. O'Callaghan, I understand that the statement 
you delivered ultimately has to be approved, correct, by CDC?
    Dr. O'Callaghan. That is correct.
    Mr. Shays. So what was taken out would be your view; not 
CDC's. I am interested to know, was there any part of your 
statement that was taken out that you felt fairly strongly 
    Dr. O'Callaghan. As you know, as a government employee, 
this has to go up the chain of command--actually, quite high.
    Mr. Shays. Right.
    Dr. O'Callaghan. And it has to even go over to the office 
    Mr. Shays. And let me just say something. You have a 
protection right now. You are under oath.
    Dr. O'Callaghan. Yes.
    Mr. Shays. Let me just say it again. Every one of you is 
under oath. You have to respond accurately to the questions I 
ask. And I am not asking an unfair question. I am asking, just 
simply, was there an issue where your statement as approved by 
CDC varied from what you wanted in any noticeable or 
significant way? And if so, what area was that?
    Dr. O'Callaghan. That is a tough question. I would say 
maybe the emphasis that was placed more broadly on the 
potential data you can gain from human studies being----
    Mr. Shays. So let me put it in my words. You were a little 
more enthusiastic than CDC would like about animal studies 
being helpful.
    Dr. O'Callaghan. Yes, and that is often the case with lab 
scientists putting forth their opinions.
    Mr. Shays. Fair enough. Fair enough.
    Dr. O'Callaghan. OK.
    Mr. Shays. You know, I am not describing any bad faith on 
the part of CDC.
    Dr. O'Callaghan. All right.
    Mr. Shays. They want to be a little more cautious.
    Dr. O'Callaghan. Right.
    Mr. Shays. Just wanted to know.
    Dr. O'Callaghan. Yes.
    Mr. Shays. I want to go over one old territory just once 
more, to make sure that I am not incorrect on my knowledge and 
    I used to chair a subcommittee of this full committee that 
oversaw all the Department of Health--the FDA, CDC, and so on. 
My recollection has been--and we have had hearings since then, 
as well--that as a general rule, when bringing out a new drug, 
we would have experiments on animals. And at some point, when 
we think that we are ready to go to the marketplace, we take 
those drugs and have studies with human beings. Is that 
correct, Dr. O'Callaghan?
    Dr. O'Callaghan. Yes, it is.
    Mr. Shays. Yes. But that presents a problem. For instance, 
if we wanted to have a prophylactic, a vaccine against some 
terrible biological agent, we could do it on animals, but then 
we may not--since there are no case studies of human beings 
contracting a particular disease, we are not going to inflict 
them with Polio--well, Polio, we had--but a particular 
biological agent. That would be unethical and wrong; correct?
    Dr. O'Callaghan. Correct.
    Mr. Shays. Right. So we are faced with this difficult 
choice of going to the marketplace just with animal studies, in 
the cases of having certain vaccines. Is that correct?
    Dr. O'Callaghan. That is correct.
    Mr. Shays. Right. And we have made a determination in a 
variety of issues to go to the marketplace without having human 
studies. I mean, this is the end result. Is that correct?
    Dr. O'Callaghan. That is correct.
    Mr. Shays. OK. Now, in that case, we had no human studies 
to validate. Is it your understanding--and I will ask you, Mr. 
Binns and Dr. Henderson--is it your understanding that, as it 
relates to Gulf war illness, if we aren't able to use human 
studies, that this process of determining, in a sense, the 
veterans the benefit of the doubt, that there is no way we can 
give them the benefit of the doubt without animal studies? Is 
that a correct way for me to view this, in your opinion, Dr. 
    Dr. O'Callaghan. For that purpose, most definitely, because 
there would be no other way to get adequate information that 
would be predictive of what would happen in man.
    Mr. Shays. Dr. Henderson.
    Dr. Henderson. I think, definitely, that is the only way.
    Mr. Shays. A little louder, love.
    Dr. Henderson. I think that is definitely true. That is the 
only way you can give the veterans the benefit of the doubt. 
And to protect them. I mean, we have found out things in 
animals about the interaction between the Pyridostigmine and 
the Sarin that wasn't known. You wouldn't find that in humans.
    Mr. Shays. So just based on what the two of you have 
responded, this almost becomes a farce. If we are going to put 
veterans through this process without animal studies, they are 
never going to get the benefit of the doubt, unless there is 
just an arbitrary decision on the part of the Secretary to just 
say ``OK.'' Mr. Binns, am I off track here, or on track?
    Mr. Binns. No, sir, let me answer by just giving you a very 
short example. If you would turn to Tab 11 of my statement----
    Mr. Shays. Titled ``Environmental Exposure Report?''
    Mr. Binns. Yes. This is the cover page of about a 2-inch-
thick study done by the Department of Defense on environmental 
exposures in the Gulf--I say ``on exposures;'' this was done on 
one exposure, the exposure to pesticides.
    And if you turn to the second page, you will see the 
conclusions: ``It is likely that at least 41,000 service 
members may have been over-exposed to pesticides.'' And turn 
the page further: ``Over-exposures to pesticides, particularly 
organophosphates and carbamates, may have contributed to the 
unexplained illnesses reported by some Gulf War veterans.''
    This is very clear language from a scientific study that 
was commissioned by our Government, and done exhaustively on 
all of the exposures of pesticides in the Gulf. This is not 
being considered by the IOM currently in its reports. To me, 
this is a much more valid type of report on which to base 
evidence than the ones that have been produced using the 
complex language of the IOM reports.
    Mr. Shays. Now, you may know, or may not know, so tell me 
if you know, and tell me if you are speculating, or tell me you 
don't know. Is it your statement before this subcommittee that 
the IOM chooses not to look at animal studies, or is prevented 
from looking at animal studies because of the way the VA has 
directed them?
    Mr. Binns. I do not know who set up the original categories 
of evidence. But whoever did, that has created the framework in 
which the IOM committees have operated.
    Mr. Shays. OK. And the category of evidence is referred to 
by this statement in part?
    Mr. Binns. Yes. It is these standards which only could take 
into account human studies and human health effects.
    Mr. Shays. OK. Let me ask each of you, to conclude. Is 
there any question we should have asked that we didn't? I want 
you to ask yourself the question; then I want you to answer the 
question. Is there any statement that you would like to make 
before we conclude?
    You have two choices here. You can do both. But if there is 
a question we should have asked you that we didn't, I want you 
to ask yourself the question. I will start with you, Mr. Woods.
    Mr. Woods. No sir.
    Mr. Shays. Thank you. Mr. Robinson.
    Mr. Robinson. The question I would ask is: Why are we not 
moving forward when the science is pushing us in a direction? 
And why is the VA, the people who are supposed to take care of 
veterans and bind up the wounds of war--what excuse do they 
have for not knowing what the current science is? And what 
excuse do they have for not listening to the committee that was 
stood up, directed by the President, appointed by the VA, to 
help them in understanding these illnesses?
    And the answer to my own question is: I don't know. But it 
is incredibly shameful. It is absolutely shameful that somebody 
in the VA can give Mike Woods placebo for real pain, and not 
tell him what it is, and he would go home and take it. It is 
shameful that--and I don't know how many other Gulf war 
veterans have been given this. We just found out about it. But 
it is shameful.
    Mr. Shays. Yes, let me be clear. That was given to you by--
    Mr. Robinson. The VA medical center in Orlando.
    Mr. Shays. No, I am not asking you, Mr. Robinson. Mr. 
Woods, I'm sorry. Mr. Woods, it was given to you by whom?
    Mr. Woods. The VA medical center in Orlando, FL.
    Mr. Shays. OK. And how do you know it is a placebo?
    Mr. Woods. It says ``Obecalp,'' which spelled backward is 
    Mr. Shays. Now, let me just be very clear. Just so you 
know, you have a lot of credibility with me, but you are coming 
before a subcommittee under oath, and saying that was given to 
you by the VA?
    Mr. Woods. Correct.
    Mr. Shays. OK. I just want to make sure you know. And when 
I ask the question this way, it puts more emphasis on you 
making sure you are correct when you are further asked about 
this. And you will be further asked about this. OK. Thank you.
    Mr. Robinson. Thank you.
    Mr. Shays. I am going to end with you, Mr. Binns. So, Dr. 
Henderson, any question we should have asked that we didn't, 
that you would like to ask yourself? Any statement you would 
like to make, before we go to the next panel?
    Dr. Henderson. I would just say for the future the question 
running around in my mind is: How do we integrate epidemiology 
and animal studies to get the most effective way to determine 
associations between exposures and effects, specific diseases?
    Mr. Shays. And so your answer would be?
    Dr. Henderson. My answer would be: We need to establish 
that new framework. And maybe the IOM could work on that, or 
the academies at least, in getting a better paradigm for 
integrating animal studies into epidemiology.
    Mr. Shays. Thank you. Dr. O'Callaghan.
    Dr. O'Callaghan. Nothing to add, thank you.
    Mr. Shays. Thank you. Mr. Binns.
    Mr. Binns. I would ask a question that you asked me, Mr. 
Chairman, a year and a half ago, at the hearing held in June 
that year, which was: Should this research responsibility be 
taken away from VA? It is apparent to me that there is a 
conflict of interest in VA conducting research which also has 
important benefits implications.
    I think that same conflict extends to other branches of the 
Government. Therefore, I would recommend that Congress 
designate that this research be conducted outside of the 
Federal Government in the future, and managed by an independent 
organization outside of the Government.
    Mr. Shays. You all have been very helpful witnesses. You 
have all contributed to our work. And frankly, a lot of what 
has been discussed today is alarming. Thank you all very much.
    [Witnesses excused.]
    Mr. Shays. Our next panel is Dr. Susan Mather, Chief 
Officer, Public Health and Environmental Hazards, Veterans 
Health Administration; accompanied by Dr. Mark Brown, Director 
of Environmental Agents Service, Department of Veterans 
Affairs; and Mr. Richard J. Hipolit, Assistant General Counsel, 
Department of Veterans Affairs.
    Our second testimony is from Dr. Lynn Goldman, Professor of 
Occupational and Environmental Health, Department of 
Environmental Health Services, Johns Hopkins Bloomberg School 
of Public Health, Institute of Medicine; and Dr. Sam 
Potolicchio, Professor of Neurology, Department of Neurology, 
the George Washington University Medical Center, Institute of 
Medicine; accompanied by Ms. Susanne Stoiber, Executive 
Director, Institute of Medicine.
    Ms. Stoiber, did I pronounce your name correctly?
    Ms. Stoiber. Very close. ``Stoiber'' is exactly right.
    Mr. Shays. Stoiber.
    Ms. Stoiber. Uh-huh. It is an Austrian variant----
    Mr. Shays. OK, well, you weren't taped, so we will try it 
again later.
    But if I could ask you all to stand, and raise your right 
    [Witnesses sworn.]
    Mr. Shays. All witnesses respond in the affirmative. And 
let me just say before we start, I have respect for all of you 
on this panel. I have had many disagreements with some of you 
on this panel, but I have respect for all of you. And while Mr. 
Binns stated his concerns, which I share completely, I don't 
share all of his recommendations, and would want that to be 
part of the record.
    But I am deeply concerned by what I heard from the first 
panel, as I think you can imagine I would be. And having been 
involved in the act in 1998, I do believe that there is no 
question about Congress' intent and the reason for Congress' 
intent. I don't think it is being lived up to, but I am willing 
to hear why I may be wrong. And I want you to testify in any 
way that you think we need to get this statement out properly 
for the record.
    We are going to start with you, Dr. Mather. And it is 
important that you put on the record anything that you want. We 
are 5 minutes, but if you go another 5 minutes, it is important 
that you do whatever you need to do.


                   STATEMENT OF SUSAN MATHER

    Dr. Mather. Thank you for that. Mr. Chairman and members of 
the subcommittee, I appreciate the opportunity to appear before 
you today to discuss the implementation of the Persian Gulf War 
Veterans Act of 1998. I will also briefly discuss the Veterans 
Programs Enhancement Act of 1998, and provide a status of the 
studies and reports on Gulf war health conducted by the 
National Academy of Sciences' Institute of Medicine.
    Mr. Chairman, you expressed interest in the extent and 
weight given to data from animal studies in determinations of 
presumptive causality of disease. I want to assure you that 
both VA and NAS carefully consider all relevant peer-reviewed 
animal studies, and we believe that we are fully compliant with 
the relevant statutes.
    In addition to VA's implementation of the Gulf War Veterans 
Act, VA also is charged with simultaneously implementing the 
Programs Enhancement Act, which establishes an overlapping 
framework for addressing issues relating to the health status 
of Gulf war veterans.
    There are several instances where these statutes take 
seemingly different approaches to the study of health risks 
associated with service in the Gulf war and to provisions of 
compensation as a result of that service. In view of the 
differences between the two statutes, on December 8, 1998, VA's 
General Counsel asked the Department of Justice for an opinion 
regarding VA's implementation of them.
    On March 12th, 1999, Justice responded in part that the 
respective provisions of the two laws, ``. . . although 
redundant and burdensome in some respects if both laws are 
given effect, are not inherently conflicting or mutually 
exclusive, and therefore the provisions of both laws must be 
treated as valid and effective.'' This is what we have tried to 
    Congress required VA to contract with NAS to conduct 
reviews of the scientific and medical literature on long-term 
health effects from exposure to environmental hazards 
associated with the 1991 Gulf war. These statutes list 
approximately 33 specific risk factors, or categories of risk 
factors, for consideration by NAS in its review process.
    I understand that you are particularly interested in the 
contracts with NAS, including their status, terms, conditions, 
and timeliness. NAS has already reviewed many of the Gulf war 
environmental hazards in a series of four reports conducted 
under contract to the VA. The initial NAS report, issued in 
2000, on Gulf war health issues reviewed health effects of 
depleted uranium, Sarin, Pyridostigmine Bromide, and vaccines.
    We understand that the NAS committee selected those 
specific risk factors to start with at the suggestion of the 
Gulf war veterans following initial public meetings they 
arranged. To evaluate the NAS reports, VA established a 
taskforce whose members included the Undersecretaries for 
Health and for Benefits, the Office of General Counsel, and the 
Assistant Secretary for Policy, Planning and Preparedness.
    Based on the taskforce's review, VA published a notice in 
the Federal Register, and informed Congress that the 
information provided by NAS did not warrant developing any new 
presumptive service connections.
    The second NAS report, issued in 2002, reviewed health 
effects of insecticides and solvents used in the 1991 Gulf war. 
The Department is currently finalizing its notice announcing 
the Secretary's determination regarding that report.
    The third NAS report, issued in 2004, reviewed health 
effects from fuels, combustion products such as smog, and 
propellants such as rocket fuels. VA's taskforce reviewed the 
report and provided recommendations to the Secretary.
    The NAS reports released to date have addressed a wide 
array of potential exposures presenting different concerns. For 
example, the reports issued in 2002 and 2004 considered a 
number of environmental hazards that are generally well studied 
and not uncommon workplace or urban exposures; such as 
gasoline, smog, common pesticides, and cleaning solvents. They 
are known to cause specific illnesses, particularly among 
civilian workers who may have had very large exposures lasting 
over many years.
    A few environmental hazards associated with the first Gulf 
war are more unusual; for example, the chemical warfare agent 
Sarin and depleted uranium, both of which were addressed in the 
2000 report. Fortunately, IOM had a large amount of medical and 
scientific literature to review on health effects from exposure 
to these agents, including animal studies. Thus, in its initial 
2000 review, and in the followup review in 2004, NAS did not 
identify any illnesses or disabilities for individuals exposed 
to trace levels of Sarin that may have occurred during the 1991 
Gulf war.
    VA's task in reviewing these reports is to decide whether 
additional presumptions of service-connected are warranted by 
current scientific evidence for particular diseases. This 
process would not in any way limit the right of any veteran 
under existing claim procedures to establish service connection 
on a direct basis, and with VA's assistance, for any disease 
that could be related to their service in the Gulf.
    IOM is currently conducting three relevant studies: one, 
the infectious diseases associated with Gulf war and Southwest 
Asia; health effects from deployment-related stress, including 
veterans involved in the current conflict in Iraq, who are 
technically also Gulf war veterans, both to be completed in 
fiscal year 2006; and new clinical approaches to treating Gulf 
war veterans suggested by a complete review of all scientific 
publications on Gulf war veterans health, which is due in 
December 2005.
    Psychological stress is being evaluated in part because it 
is seen as a major concern in the current Iraqi conflict, which 
is taking place in the same geographic area as the Gulf war.
    IOM's studies will assess the health threats for troops 
serving in Iraq today, who share many hazardous exposures with 
prior Gulf war veterans. Psychological stress was chosen 
because it may be a major co-factor with other environmental 
health threats. For example, it is hypothesized that greater 
concentrations of an anti-chemical-warfare agent, PB, enter the 
brain during times of stress.
    Because of concerns raised by a series of scientific 
publications that suggest that veterans from all eras may be at 
greater risk for ALS, in August VA asked IOM to look at 
evidence for increased risk of Lou Gehrig's Disease among all 
U.S. veterans, not just Gulf war veterans. This review will 
take an estimated 9 months to complete.
    I would like to address a contractual relationship between 
VA and NAS, and the role of NAS in VA's decisionmaking process 
that translates Gulf war and health reports into health care 
disability compensation policies.
    VA establishes the basic contracts with IOM to conduct its 
periodic reviews of the medical and scientific literature on 
Gulf war risk factors, according to the statutory requirements. 
It is important to reemphasize that after IOM completes one of 
its reviews, it is not involved in the Department's 
decisionmaking process.
    Part of the value of IOM to both VA and veterans is its 
reputation for independence and scientific rigor. In support of 
this, VA does not provide precise guidance to IOM on how to 
conduct their studies, beyond the basic required contract which 
explicitly states the goal of the study. For information on how 
IOM incorporates the data from animal studies it reviews, VA 
defers to IOM; since it can best answer these questions.
    From the onset, VA asks IOM to evaluate all available 
medical and scientific literature, which includes studies of 
both humans and animals. The ultimate point of this process is 
to evaluate potential health effects relevant to veterans.
    VA and IOM emphasize findings from human clinical and 
epidemiologic studies as being the most relevant to the 
veterans' health effects. Part of this distinction occurs 
because laboratory animals often do not respond to hazardous 
exposures in the same manner as humans; and therefore, it can 
be dangerous to predict clinical effects in humans based solely 
upon toxicologic observations in laboratory animals.
    For example, in one IOM report, they describe a nearly 
40fold range in toxicity of Sarin among various laboratory 
animals. It is difficult to say which, if any, of these results 
would be the most reliable predictor of human toxicity.
    Animal studies are essential to planning relevant research 
studies. But the most useful data for predicting health effects 
in humans is based upon human studies.
    In the absence of human studies, animal studies may become 
the logical starting point for considering potential human 
health effects. However, when there are numerous human studies 
available, they will probably be the most reliable predictors 
for future health effects among humans.
    Finally, in cases where an effect is observed in an animal 
study but not observed in a well-conducted epidemiologic study, 
then the conclusion would have to be that the animal study is 
probably not clinically relevant to humans.
    However, it would be erroneous to conclude that either IOM 
or VA somehow excludes data from animal studies from the 
consideration of possible health effects among humans. For 
example, in his 2003 letter to the IOM, former Secretary 
Principi requested an updated study on Sarin health effects 
focused upon new animal studies, and directed IOM to consider 
the new animal studies.
    It is clear that the IOM committee reviewed numerous animal 
studies in reaching their conclusions. On pages 26 to 46 of the 
report, the IOM committee cites results from 101 animal studies 
and reviews. The committee also reviewed many directly 
applicable human studies, including studies of Gulf war 
veterans possibly exposed to Sarin as a result of the 
demolitions in Khamisiyah.
    The human studies IOM analyzed were highly relevant to 
evaluating possible effects among Gulf war veterans. The non-
Gulf war veterans studies reviewed were based upon U.S. 
military volunteers who had been exposed several decades ago to 
non-lethal doses of Sarin and other chemical warfare agents, on 
industrial workers with documented acute exposure to Sarin, and 
upon victims of the Sarin terrorist attacks in Japan in 1994 
and 1995.
    The committee also specifically reviewed the new published 
data from laboratory animals that had precipitated interest in 
an updated study of Sarin health effects mentioned by former 
Secretary Principi in his letter.
    The committee concluded that the animal studies were an 
important step in determining whether a biologically plausible 
mechanism could underlie any long-term health effects of low 
exposure to chemical nerve agents, but more work needs to be 
conducted to elucidate potential mechanisms and clarify how the 
cellular effects are related to any clinical effects that might 
be seen.
    VA has wide statutory authority to make such a 
determination based on sound medical and scientific evidence 
that is not limited to the IOM committee findings in 
determining presumption of illness. VA has responsibility for 
determining what weight to place upon various studies in 
reaching any health care or disability compensation policy 
conclusions, which are then published in the Federal Register 
at the same time Congress is informed.
    Based upon this approach, VA complies with the statutory 
mandates to assess the extent and weight of data from human and 
animal studies in developing presumptive service connection 
    Thank you again for the opportunity to be here. My 
colleagues and I will be glad to answer any questions you may 
    [The prepared statement of Dr. Mather follows:]
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    Mr. Shays. Thank you very much.
    Dr. Goldman.


    Dr. Goldman. Good afternoon, Mr. Chairman, and thank you 
for holding this hearing today. We really appreciate your 
interest in the health of the veterans.
    I am Lynn Goldman. I am a professor of environmental health 
sciences at the Johns Hopkins School of Public Health. And as 
you know, I served as Chair of two of the Institute of Medicine 
Gulf War committees; one is the committee that is currently 
working on the report, ``Gulf War and Health: Review of the 
Medical Literature,'' and another committee that produced the 
report, ``Gulf War and Health: Fuels, Combustion Products, and 
Propellants.'' In addition, I was a member of the committee 
that produced ``Gulf War and Health: Insecticides and 
Solvents.'' And therefore, I think that I am qualified to talk 
to you about this particular process.
    I want to step back for a moment, and reflect on the four 
separate issues that I have heard discussed today. Because, Mr. 
Chairman, I think it is very important to understand that these 
are separate processes completely.
    One is the implementation of the statutes that were enacted 
by this body with regards to how the veterans would utilize 
advice from the Institute of Medicine in determining 
compensation for Gulf war related illnesses.
    But I have also heard questions with regards to how the 
research agenda is created, how veterans' physicians are 
educated, what they know about exposures in the Gulf; and also, 
even how do we protect soldiers in the future against harmful 
exposures. Those last three questions, I am not going to 
address in my testimony; not because I don't think they are 
important. I think they are exceedingly important questions 
that have been raised. I am going to merely talk about how the 
Institute of Medicine has provided advice under the statutes.
    And I can assure you right from the get-go that at no time 
in any of the committees in which I have participated have I 
observed any interference by either the Department of Veterans 
Affairs or the Department of Defense. I think that is very 
    These have been independent scientific committees. The 
scientists involved wouldn't stand for that kind of 
interference for a moment. They wouldn't serve as volunteers, 
if they were serving under those conditions. And so, I just 
want to put that issue aside.
    I think that the issue, though, that is of great importance 
is how we have evaluated the evidence; and particularly, how we 
have utilized animal studies in so doing.
    As has been pointed out, the committees have used criteria 
in order to assign levels of evidence, categories of 
association for various exposures during the Gulf and 
subsequent illnesses, chronic illnesses that occur years after 
those Gulf war deployments. And we have been very concerned to 
make sure in doing that we can definitely form a linkage 
between those exposures and actual human disease.
    In so doing, each committee has gone back to the categories 
of association, and labored over how it wanted to tailor those 
categories to its work. And in the committees that I have 
chaired and that I have been a member of, we have come back and 
back and back, both to the words and the statute, the charge 
from the VA and the categories of association; and worked those 
over, so that we felt that we were evaluating the evidence in a 
way that would be scientifically defensible, given the 
questions that we were being asked. I think it is also 
important to state that it is not at all true that animal 
studies have been ignored in this process.
    Mr. Shays. I don't usually interrupt someone, but ``given 
the questions we were asked'' by whom?
    Dr. Goldman. Given the questions that we were asked by the 
legislation and by the VA in our statement of charge.
    Mr. Shays. By the VA.
    Dr. Goldman. Which had to do with, again, exposures to 
substances during deployment and subsequent clinical illness 
years later. Those were the questions that we were looking at. 
And I think that those are, as I said before, very different 
questions than questions such as: How do you protect veterans 
in the future? How do you educate the physicians in the VA? 
What should be the research agenda for the VA? We were never 
asked those questions.
    I think that it is important to state that we have relied 
not only on, of course, epidemiology and clinical evidence, but 
also animal evidence. And I want to explain a little bit about 
how we did that. In the first place, certainly, we never have 
felt--none of the committees have felt--that animal data could 
be used as a sole basis for answering that kind of question 
about an exposure to people and then later illness. We have 
never felt that we could rely on animal evidence alone.
    Why is that? First, animal data can tell us about a 
category of health outcomes, without telling us exactly which 
disease will be created. And so we know from human studies that 
the chemical vinyl chloride causes a cancer called angiosarcoma 
of the liver. But when we give that substance to animals, we 
can see other cancers as well, such as cancer of the zymbal 
gland of the rat. Now, humans don't have a zymbal gland; so we 
are not going to get that cancer. And it is only through the 
human epidemiology studies that we can say it is a specific 
liver cancer that would be caused.
    On the other hand--and this has been said earlier in 
testimony--those animal studies may be the best studies that we 
have for determining the potency, the dose response, how much 
dose gives you how much cancer. These animal studies are of 
vital importance for potency. But they can't tell you exactly 
which disease is going to be diagnosed in the person; and I 
think that is an important point, especially for cancers, birth 
defects, and certain other outcomes.
    Second, many animal studies are not carried out in a way 
that is relevant to the experience. We are looking at exposures 
occurring at a certain point in time in people's lives; 
illnesses much later. Many animal studies involve chronic 
dosing, day after day after day, sometimes beginning in what 
would be the equivalent of childhood of the animals, and 
exposures that do not cease. Whereas in the Gulf experience, 
what we are concerned about is exposures that occur; cease; and 
then there is subsequent illness.
    That is also a challenge with looking at many of the 
epidemiology studies, and something that we confronted as 
scientists over and over again in trying to do this charge.
    The third point is that often times we actually relied on 
preexisting reviews of the animal toxicology. A lot of effort 
is gone into for some very well studied chemicals such as 
Benzene, which we looked at in the first committee I served on. 
Benzene has been reviewed again and again. And in those cases, 
we often relied on the work that authoritative bodies have 
already done to generally review the toxicology where it was 
not controversial, and then we picked out--our experts who were 
toxicologists picked out specific studies that they thought we 
needed to examine individually in order to do our reviews.
    So again, no interference was ever observed by me by any 
government agency, or any other outside group, to this work. 
And second, while we did rely primarily on human studies, 
animal studies have also played a role.
    And in closing, I do want to say that I think it is very 
important that you are undertaking this careful reassessment of 
this process. I do believe that this is a process that is very 
important to the health and well being of our veterans. And I 
also think that it is a process that does deserve to have 
careful oversight by Congress and by your subcommittee, and 
that oversight is most welcome. Thank you very much.
    [The prepared statement of Dr. Goldman follows:]
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    Mr. Shays. Thank you, Doctor.
    Dr. Potolicchio.


    Dr. Potolicchio. Good morning, Mr. Chairman, again, and 
members of the subcommittee. I am Dr. Samuel Potolicchio. I am 
a clinical neurologist with the George Washington University 
    In addition, I have been a volunteer member of committees 
that produced or are currently preparing the following four 
Institute of Medicine reports: ``Gulf War and Health: Review of 
the Medical Literature Relative to Gulf War Veterans Health,'' 
``Gulf War and Health: Fuels, Combustion Products, and 
Propellants,'' ``Gulf War and Health: Insecticides and 
Solvents,'' ``Gulf War and Health: Depleted Uranium, 
Pyridostygmine Bromide, Sarin, Vaccines,'' and the ``Gulf War 
and Health: Updated Literature of Sarin.'' It was a long road.
    Because of my experience on those committees, and in 
particular my work on the Sarin report, the IOM requested that 
I testify on the work of the Sarin committee. I am the longest-
living member, I think. I appreciate this opportunity to speak 
with you about the Sarin report.
    The Sarin report was conducted following a request from the 
Department of Veterans Affairs to update an earlier report on 
the potential human health effects of Sarin. That request 
followed the publication of a series of toxicology studies on 
rats looking at the effects of relatively low concentrations of 
    Sarin, as everyone knows, is a highly toxic nerve agent 
produced for chemical warfare. Sarin can be fatal within 
minutes to hours. It is a member of a class of chemicals known 
as ``organophosphorus compounds.''
    In humans and other animals exposure to high doses of Sarin 
produces a well-characterized syndrome, the acute cholinergic 
syndrome, featuring a wide variety of signs and symptoms, 
including: increased salivation; lacrimation, or increased 
tears; perspiration, even bloody tears; blurring of vision; 
nausea; vomiting; diarrhea and fecal incontinence; excessive 
secretions in the bronchi and respiratory system; tightness in 
the chest; cough; tachycardia, or quickened heart rate; 
increased blood pressure; drowsiness and lethargy; mental 
confusion; headache; coma; and convulsions. It is important to 
remember that the acute cholinergic syndrome is a very serious 
effect that requires medical attention and can lead to death.
    I would like to note that, as with the committees discussed 
by Dr. Goldman, at no time during the preparation of ``Gulf War 
and Health: Updated Literature Review of Sarin'' did anyone 
outside of the committee process influence the work, 
deliberations, or outcomes of the studies.
    In drawing its conclusions, the Sarin update committee 
evaluated relevant studies that were identified in searches of 
data bases that identified approximately 250 articles that were 
potentially relevant to the committee's charge. Those articles 
included studies in humans and in animals. On the basis of 
those studies, the committee reached its conclusions.
    The committee, as with previous Gulf war and health 
committees, made conclusions regarding the existence of the 
acute cholinergic syndrome following Sarin exposure, the 
existence of persistent effects in individuals exposed to Sarin 
who had the acute cholinergic syndrome, and the existence of 
persistent effects in individuals exposed to Sarin who did not 
have any signs of having had the acute cholinergic syndrome.
    The first conclusion is that there is definitely sufficient 
evidence of a causal relationship between exposure to Sarin and 
a dose-dependent effect, seen at high doses, of acute 
cholinergic syndrome that is evident in seconds to hours after 
Sarin exposure and resolves in days to months.
    That conclusion is based on data from humans exposed to 
Sarin, and is supported by data in animals and on 
organophosphorus pesticides which are related chemically to 
    The second conclusion is that there is limited, suggestive 
evidence of an association between exposure to Sarin at doses 
sufficient to cause the acute cholinergic signs and symptoms, 
and a variety of subsequent long-term neurological effects. As 
with the previous conclusion, that conclusion is based on data 
from humans exposed to Sarin, and is supported by data in 
animals and data on organophosphorus pesticides.
    And finally, the committee concluded that there is 
inadequate, insufficient evidence of an association between 
exposure to Sarin at low doses insufficient to cause acute 
cholinergic signs and symptoms, and subsequent long-term 
adverse health effects; specifically, neurologic and 
cardiovascular effects. That conclusion was based on a lack of 
data in humans or animals.
    I will focus on this last conclusion; as the first two 
conclusions are relatively well established, and not 
    As with other Gulf war and health committees, the Sarin 
update committee first reviewed the human studies. There were 
data from studies of United States and U.K. servicemen who 
several decades ago--between the years of 1958 through 1984--
volunteered to be exposed to chemical weapons, including Sarin. 
It also included industrial workers with documented acute, 
high-dose exposures to Sarin; victims of the Sarin terrorist 
attacks on Japanese subway systems; and studies of Gulf war 
    All of those studies, with the exception of the studies of 
Gulf war veterans, focused on the effects in individuals who 
had shown the signs and symptoms of the acute cholinergic 
syndrome, and therefore do not provide information on the 
effects of Sarin at concentrations below those that cause the 
acute cholinergic syndrome.
    The studies conducted in Gulf war veterans--including 
United States, U.K., Danish, and Canadian veterans--were not 
very useful in making specific conclusions regarding the health 
effects of Sarin, because many do not have objective 
assessments of exposure to Sarin--for instance, many rely on 
self-reports of exposures in surveys taken years after the war, 
or are in individuals not deployed to the Gulf until after any 
of the potential exposures to Sarin are thought to have 
occurred--or have other problems with the exposure assessment. 
In addition, no health outcomes were consistently seen in those 
    Given the limitations of the epidemiology studies, the 
committee then reviewed the available toxicology data, focusing 
on those studies conducted with doses below those that cause 
the signs and symptoms of acute cholinergic syndrome, to draw 
conclusions related to lower exposure to Sarin and health 
    Although few studies have evaluated the effects of such 
doses, a recent series of studies by Dr. Rogene Henderson, 
which are the studies that prompted the IOM Sarin update, have 
evaluated the effects of low-dose Sarin exposure in rats.
    Those studies did show some alterations in some subtypes of 
a specific family of receptors in certain areas of the rats' 
brains. But no consistent and persistent effects were seen in 
the levels of the neurotransmitters and on behavioral 
parameters in the rats.
    The data on receptors indicate further research areas, but 
are not correlated with any particular health outcome in rats; 
let alone humans. Those data on receptor density, therefore, 
are not sufficient to indicate an association with a human 
health effect; especially given the fact that behavioral 
effects were not seen in rats treated with Sarin at the same 
concentration. Animal studies by other researchers looking at 
low-dose effects also showed inconsistent, if any, effects.
    In summary, the committee concluded that there is 
sufficient evidence of a causal relationship between exposure 
to high amounts of Sarin and the acute cholinergic syndrome, 
and there is limited, suggestive evidence of an association 
between exposure to Sarin at those high levels that cause the 
acute cholinergic syndrome and a variety of subsequent long-
term neurologic effects.
    However, given the few epidemiology studies, the limitation 
of those studies that look at the effects of exposure to low 
concentrations of Sarin, and the limited number of relevant 
toxicology studies and their inconsistent results, the 
committee concluded that there was inadequate, insufficient 
evidence to determine if there is an association between 
exposure to Sarin at levels that do not cause the acute 
cholinergic syndrome and any human health effects.
    Those conclusions were based on available scientific data, 
and they were made by the committee without any external 
pressures or interference.
    With that, I would once again like to thank you for 
inviting me to testify before this subcommittee. I appreciate 
the work of this subcommittee on National Security, Emerging 
Threats, and International Relations, and am happy for your 
interest in this important area of veterans' health. I look 
forward to answering any questions you might have.
    [The prepared statement of Dr. Potolicchio follows:]
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    Mr. Shays. Thank you, Doctor. I am going to have the 
Counsel start with the questions, and I will be, probably, 
interrupting him.
    Mr. Halloran. Thank you. Dr. Mather, I see you brought your 
lawyer. And your testimony contains a discussion of two 
relevant statutes. Why? Do you think they conflict?
    Dr. Mather. Well, I am not a lawyer, and I have brought a 
lawyer with me for just that reason. But certainly, as a person 
involved with implementing both the laws, there were areas that 
seemed inconsistent to me.
    Mr. Halloran. Does one of those areas include or encompass 
the way VA would approach the use of animal data?
    Dr. Mather. No.
    Mr. Halloran. It does not?
    Dr. Mather. But at the time when we were setting up the 
implementation plan for this, we had enough questions that we 
referred them to General Counsel. And I will let Mr. Hipolit 
take over from there, since he is a lawyer and I am not.
    Mr. Hipolit. At the time those two statutes were passed, 
there appeared to us to be several inconsistencies in the 
statutes that took a somewhat different approach to the same 
issue. So we were somewhat confused as to, you know, how we 
would implement the two statutes.
    We went to the Justice Department, to the Office of Legal 
Counsel, for advice as to how we would--you know, if one 
statute would supersede the other, or if we were to try to 
implement both, or whatever. We received an opinion from the 
Office of Legal Counsel indicating that both statutes--the 
statutes were not mutually exclusive, essentially; that we 
could reconcile the two, implement both statutes. And they gave 
us some advice as to how to reconcile some of the apparent 
    Mr. Halloran. So it is not the Department's testimony, 
then, that the statutes, read side by side--if one uses 
different words to describe the role of animal data, or animal 
studies, in this mechanism, that you simply are allowed to 
choose the lesser approach to animal studies?
    Mr. Hipolit. No, animal studies wasn't part of the----
    Mr. Halloran. It wasn't?
    Mr. Hipolit. That wasn't one of the things we identified as 
an inconsistency and asked Justice about.
    Mr. Halloran. So it is possible that the Department's 
approach to animal data is violating both statutes?
    Mr. Hipolit. No, I wouldn't say that. The animal data just 
wasn't an issue as far as reconciling the two statutes.
    Mr. Halloran. Was the Programs Enhancement Act the act 
under which you proceeded with these three latest IOM studies?
    Dr. Mather. Well, both of the laws involve infectious 
diseases. In one, it used Sand Fly Fever, Leach Meniasis----
    Mr. Halloran. Well, no, my question was----
    Dr. Mather. The other one was Malaria. So one of the 
studies that the IOM is going to do is infectious diseases. 
Both of the laws had a list of infectious diseases. One 
included Malaria; the other one didn't. And as a broader 
approach, the IOM, who is as independent as they have given the 
impression here today, thought that the broader infectious 
diseases was a better approach than limiting it to Sand Fly 
Fever and Leach Meniasis.
    Mr. Halloran. But the question was, Mr. Binns testified 
that the Research Advisory Committee wasn't advised about the 
construct of these studies, as they may have been for past 
studies. And so I made the assumption you were proceeding under 
a statute that didn't necessarily refer to or involve the 
Research Advisory Committee. Is that not the case?
    Dr. Mather. Well, it would be unusual for us, as we work 
with the IOM in both fulfilling legislative mandates and 
sometimes things that we feel we need that don't have a 
legislative mandate but could use their advice on, it is 
unusual for us--I can't think of an instance where we have 
taken that to a VA advisory committee; no matter what the 
subject was. So that is just not the way we do business.
    Mr. Halloran. Right. So let's say that, because one of 
those studies was about ALS, in which your testimony says, 
``This study arose out of concerns raised by a series of recent 
scientific publications that suggested veterans from all eras 
may be at a greater risk for this disease.'' Can you describe 
those publications? How many? Are they peer-reviewed?
    Dr. Mather. They were all peer-reviewed. There is a fair 
amount of literature on ALS. The recent studies, though, were 
specifically on ALS in veterans. And the studies appear to 
indicate that all veterans, no matter what era, have a higher 
risk of ALS than do people who did not serve in the military.
    This may be consistent with other non-veterans studies that 
show athletes have a higher rate of ALS--Lou Gehrig was an 
athlete--and show that pilots and people in the air industry, 
stewardesses--or they don't call them ``stewardesses''--
attendants, flight attendants, have a higher rate of ALS.
    Mr. Halloran. So would such a finding, if the study comes 
back and says, ``Yes, indeed, we find that there is no specific 
incidence or spike in ALS among Gulf war veterans, but among 
all veterans,'' that would preclude under the law, then, VA 
from making a presumptive conclusion or association between 
Gulf war service and ALS?
    Dr. Mather. I can't speak for the Secretary, but the 
Secretary could make a presumption for all veterans, that ALS 
was a risk of military service. He could.
    Mr. Halloran. Right. Thank you.
    Dr. Mather. That would include Gulf war veterans.
    Mr. Halloran. Were you and/or Dr. Brown involved or aware 
of the change in the associational standard that Mr. Binns 
    Dr. Mather. No. Today was the first day that I had actually 
seen a reference to me, the two, the IOM studies, talking about 
Agent Orange or talking about Gulf war illnesses are the same. 
And in my experience, the five categories are based on 
occupational health ways of looking at association, and go back 
to one that was not congressionally mandated, but that I was 
involved with, with mustard gas and the experiments that took 
place during World War II, and the subsequent health effects.
    Perhaps Dr. Brown.
    Dr. Brown. Yes, I would just add that I had never noticed 
that difference before. And I was thinking about it, as I saw 
it up there. I think my reaction to that is that, I mean, 
clearly, one has the word ``human,'' and the other doesn't. But 
I would caution about over-interpreting what that means.
    I think that, in a practical sense, the way that the 
Institute of Medicine reviews Agent Orange studies for us, the 
studies that we use for Agent Orange to establish--essentially, 
the same process to establish presumptive service connection 
for Agent Orange health effects--is exactly the same as the 
process that they use to evaluate the corresponding literature 
on Gulf war health effects.
    And by that, I mean they--as Dr. Goldman and Dr. 
Potolicchio pointed out, they do rely primarily on 
epidemiological studies; but they also consider a wide range of 
animal studies. In essence, from a practical standpoint, they 
are identical.
    You have heard there are over 100 animal studies, for 
example, that were part of the recent Sarin update, just to use 
that as an example of a Gulf war study. If you look at the most 
recent veterans and Agent Orange study, they reviewed hundreds 
and hundreds of animal studies along the same lines, looking at 
biological plausibility, using it to reinforce the 
epidemiological data.
    And I would just add that in the history of the Agent 
Orange studies, the Agent Orange studies which VA uses to 
establish presumptive service connections for Agent Orange 
herbicide health effects, VA has never established a 
presumptive service connection based solely on animal studies. 
That has just never occurred. So from a practical standpoint, I 
think that distinction--well, it has no practical distinction.
    Mr. Halloran. OK. Well, I don't take that as good news. 
Words have meaning, and the statute was passed here--well, let 
me go back.
    So that has never been done before. Because in the normal 
course of events, without any Gulf War Health Act, the VA 
would, when it received definitive scientific evidence of a 
link between a cause and effect in terms of human disease and 
you found that cause in a veteran, you would associate it and 
connect it with his service and be on your way; is that 
correct? Individually, or as a group, that's how it works.
    Dr. Brown. Well, I am not sure about that. I can't think of 
too many presumptives that we have established. You could----
    Mr. Halloran. No, not presumptives.
    Dr. Brown. You could do that----
    Mr. Halloran. No, not presumptives. Just cause and effect. 
Just service connection.
    Dr. Brown. Well, let me give you an example. The 
publication that Dr. Mather pointed out, showing greater rates 
of ALS amongst not just one group of veterans, but amongst all 
veterans from World War II onward, that causes a great deal of 
alarm. It seemed like a pretty good study, a well-done study, 
large groups of veterans all the way up to Vietnam, Korean War, 
and so forth.
    We decided that it was such a controversial issue and such 
a difficult issue that we turned to the Institute of Medicine 
to help us try and evaluate that overall scientific literature 
on ALS, on the relationship between ALS and military service. I 
think actually, as I understand it from discussions from the 
Institute of Medicine when we were considering how to do that 
study, there are actually dozens of studies, a few dozens of 
studies, that pertain to veterans and ALS.
    We think that is an important issue. Obviously, you know, 
we want to find out about that. And if it is a real effect, we 
could consider the possibility of presumptive----
    Mr. Halloran. Let's go back to that word, though, because 
my point is this: that the statute was passed for a reason. 
Those words were written there for a reason: to make the VA do 
something different than it would otherwise do, in the 
treatment of Gulf war veterans who present themselves as ill. 
And so I guess my one question is, what different did you do?
    I mean, it is not persuasive testimony to say that the 
Institute of Medicine, which has always approached the 
relationship between epi data and animal data in this way--that 
you didn't interfere with them. I mean, somebody who is already 
doing what you want them to do doesn't need to be interfered 
    Dr. Brown. OK, I take your point. That is a good question.
    Mr. Halloran. So I don't find that persuasive evidence of 
    Dr. Brown. That is a good question. I guess I would answer 
that by----
    Mr. Halloran. What different did you do because of this 
    Dr. Brown. Actually, I would say we did nothing different. 
What we did was, we asked the Institute of Medicine to consider 
the entire body of scientific literature. And by ``all 
literature,'' we meant all literature. We meant animal studies, 
we meant human studies, or any other relevant literature. When 
we say ``all the relevant literature,'' that is what we meant. 
And I think that is what the Institute of Medicine gave us.
    Dr. Mather. And I think that you perhaps could ask the 
Institute of Medicine why the word ``human,'' because we 
certainly didn't ask for it. As far as I am concerned, you 
could take it out, without a loss; or add it to the Agent 
Orange ones, without any great loss. So, you know, to me, it is 
a point without a difference. But the experts are here, so why 
don't we ask them?
    Mr. Halloran. Sure. Please.
    Dr. Goldman. Well, let me tell you what I think that we did 
that was very different and, I think, relates back to the 
statute. And what was put up on the board was ``The criteria 
for evidence is sufficient to conclude there is a positive 
association.'' But there was another level of evidence that is 
below that, that is ``Evidence is limited and suggestive;'' 
which is a level of evidence that was created by the statute 
because of the presumption that was built into the statute of 
leaning toward the veterans, in terms of finding an 
    And when you look at--and I attached it to the written 
testimony, which I hope will be appended to the record--when 
you look at the table of all the conclusions that have been 
developed by these committees, in fact, many of the conclusions 
have been in this ``limited and suggestive'' area.
    I can't tell you how hard it was for groups of scientists 
to do this. This is not what scientists normally do. This is a 
shade of gray; where we usually try to stay away from it. We 
usually try to say it is either--you know, it is either 
probable or possible, or not. And if you look at every single 
expert process, other than this one, this layer doesn't exist, 
this particular stratum. It is here because of the law.
    And I think that it is something to really look at, in 
terms of the oversight, in terms of what is going to be done. 
We weren't sure. We never tried to stray into that as a 
committee. We never wanted to talk about what the implications 
would be of our findings. We knew that we were there to talk 
about the science, and not the policy implications. But 
clearly, you know, this is a major policy issue, in terms of 
what is done with these conclusions about ``limited and 
    Mr. Halloran. Dr. Goldman, Dr. Potolicchio, do you find a 
discussion of the animal efficacy rule in terms of a parallel 
to this, in terms of a different approach to animal data in 
these decisions or discussions, do you find that parallel 
    Dr. Goldman. No, I don't, actually. Again, I would agree 
with some of what was said earlier; that if one needed dosing 
studies, as one might need for a pharmaceutical, a vaccine, or 
perhaps to understand acutely what a nerve agent does to you, I 
wouldn't want to see those done on people. And you would want 
to be able to infer from animals what is going on with people.
    However, in that context, you are doing something 
different. You are doing something different. You are finding a 
parallel to something that is a known response in people.
    And the problem really is with not so much the sensitivity. 
I think animal studies can be very sensitive about finding that 
there is an effect. And they can be very useful in telling us 
the dose response. But it is specificity: Is the specific 
effect that you see in an animal the same effect as the effect 
you might see in a person? That is very difficult. And so, you 
know, we don't have patients who come in to Dr. Potolicchio 
with a chief complaint of having trouble running a maze. And, 
you know, that is what the challenge is in connecting the data.
    Dr. Potolicchio. Do you want my comment as a clinician.
    Mr. Halloran. Sure.
    Dr. Potolicchio. Well, if you take the animal data, for 
instance, let's say there were studies that were done in 
monkeys with Sarin, and humans. And the interesting thing about 
it is that it changed a test, one test, which was an EEG; which 
is something I know a lot about. The changes that were induced 
by Sarin in the monkey and the human were about the same, but 
there was no real health outcome from that. It was a test 
    And so we took that information and we said, ``Well, OK, 
this is suggestive.'' I mean, not sufficient, but suggestive of 
something going on. In the same way that in an animal you may 
measure some receptor that changes a subtype because you expose 
it to some Sarin for a certain period of time. But what does 
that mean in regards to the human? Probably, nothing at all; 
until you do the same kind of exposure and see whether it 
changes the same thing. But it is a hard thing to do.
    But there is no clinical outcome. There was no behavioral 
outcome, either, in the rat. There was none at all. And so 
therefore, you have some change that occurs in the brain that 
has no meaning, really. I mean, it is science, and you need to 
go forward with that.
    But if it were like, say, the dopamine receptor in the 
brain that has a lot more to do with Parkinson's Disease, and 
then we found that Parkinson's Disease had a higher level among 
veterans, that is where you get into plausibility and cause. 
And we don't have that.
    Mr. Halloran. So in terms of what you are saying, what kind 
of animal--I am assuming and hoping there won't be human epi 
data about Sarin exposure any time soon that we can look to----
    Dr. Potolicchio. There is, but----
    Mr. Halloran. There is, I know, but I just don't want any 
    Dr. Potolicchio. Fair enough.
    Mr. Halloran. What kind of animal data would you look for 
to push plausibility into likely association; a study result 
that would show what? Fill in the gap that you see in terms of 
animal data.
    Dr. Potolicchio. Well, if you look at that receptor type, I 
mean, you would expect some changes in cognition, maybe an 
increased incidence of Alzheimer's Disease or something like 
that. I mean, it would have to have some clinical implication.
    Mr. Halloran. OK. Dr. Mather, on page 7 of your testimony, 
you say, ``VA's task in reviewing these reports is merely to 
decide whether additional presumptions of service connection 
are warranted by current scientific evidence.'' We heard before 
there aren't any now, though. Is that word ``additional'' 
    Dr. Mather. Well, I mean, the studies are still underway. 
There were 33 categories of exposures that need to be looked 
at. We are in the process of looking at them. There may well be 
additional presumptions during that----
    Mr. Halloran. But additional to what? Are there 
presumptions now?
    Dr. Mather. Well, I was just thinking of the entire 
general. We have some presumptions: the presumptions for Agent 
Orange, the presumptions for Mustard Gas, the presumptions for 
MS and Leprosy, are the ones immediately come to mind.
    Mr. Halloran. Thank you.
    Mr. Shays. I have a few questions that I want to ask. I 
listened to what the Counsel was asking in the beginning about 
the two statutes. And I found myself thinking, you know, 
``There we go again.'' It is very difficult for someone without 
a scientific background or a health background to sort out a 
lot of these questions. So I don't need you all to make it more 
    And for you to come in and talk about two statutes as if it 
is relevant to the hearing--because I was left with the 
impression, well, the statute requires that you need to use 
animal data. And then you come in and say, but there is another 
statute that you thought was in conflict. And then the counsel 
basically says it is not in conflict. And I am thinking, 
``Well, you are talking about animal data;'' and that somehow, 
in one statute you had to use animal data, and in another one 
you didn't. And then we find out when we ask you the question 
that the conflicts don't even relate to animal data.
    So I am wondering, why the hell do you even bring it up? 
Why is it even an issue at this hearing? So someone tell me 
    Mr. Hipolit. I believe that was included in the statement 
by way of background. I think that portion of the statement 
reviewed VA's statutory obligations, in general, in this area.
    Mr. Shays. So the bottom line is it is totally irrelevant, 
though, to the issue at hand, as it relates to animal data. 
    Mr. Hipolit. As far as if we are talking about whether we 
should use animal data to create presumptions, it is not really 
helpful, I think.
    Mr. Shays. It is totally irrelevant, and not helpful. That 
is the bottom line.
    You know, you all may be right in the end about this. I 
mean, Dr. Goldman maybe what you say is something I have to pay 
more attention to. But I have to clear my mind of this whole 
thing about the statutes, because they are not in conflict. 
They aren't in conflict as it relates to animal data. They both 
make reference to animal data.
    And so, now, Dr. Goldman, I believe that we said animal 
data has to be considered. That is what I believe. And I 
believe your statement is saying, ``We considered it, but--
but--but--but--but--but--but--'' So I am led to believe that 
you really didn't consider it, because you think animal data 
isn't relevant. So, ``Screw Congress, forget the law, we have 
decided in our scientific way it is not relevant.'' That is 
kind of the way--I am giving you the short, more concise 
version of what is in my head right now. So given what I just 
say, please respond.
    Dr. Goldman. That certainly is not what I intended to 
communicate in my testimony.
    Mr. Shays. You have to turn on your mic. Start over again, 
    Dr. Goldman. It is certainly not what I intended to 
communicate in my testimony. We certainly did take the language 
in the statute seriously. As scientists, we feebly tried to 
read it ourselves. We didn't feel that it was--that the 
statutes were contradictory.
    We did review the animal data. We reported on it. We 
referenced them. And we in no way wanted to do anything except 
honor the intent of Congress and do the best job that we could 
as scientists.
    We had on our committees toxicologists who specialize in 
both generating and analyzing that kind of data; are not 
involved with epidemiology, clinical medicine or science at 
all. And we were very respectful of their views; involved them 
in looking at every single chemical. So it is not what I meant 
to convey at all, and I hope that you can hear that.
    Mr. Shays. Let me ask you, I understand that if we are 
going to introduce a new drug into the marketplace, we don't 
want to have any mistakes. It has to be as perfect as we can 
make it. Is it your view that in order to make a presumption of 
a service-connected disability illness, that we need to rise to 
that same test?
    Dr. Goldman. I think it is up to Congress to decide what 
the test should be. I think that, actually, the language in the 
statutes is very different than the language that one uses as a 
standard for introduction of a new drug.
    When FDA reviews a new drug, it is doing kind of a risk/
benefit determination. There are risks of drugs, but there are 
benefits; and FDA tries to decide on the side of the patients 
that the benefits outweigh the risks.
    I don't think that is how the legislation was written. It 
is not how we read the charge that came from that legislation. 
We felt that the presumption should be slanted toward the 
veterans, in terms of making sure that the veterans' health is 
adequately protected; which is why there is a category of 
``limited and suggestive'' health effects, and why we took that 
part of it very seriously. So I think it is different.
    I think it is also different, by the way, for introduction 
of the chemical exposures in this society. If one were to think 
about to what chemicals would it be acceptable for soldiers in 
combat to be exposed in the future, that would be a very 
different kind of review that might well rely almost completely 
on animal toxicology. Because there, you are not trying to look 
at a specific diagnosis, a clinical diagnosis. You are looking 
at risk. And I think for risk assessment you can solely rely on 
animal data. You don't need human epidemiology studies for risk 
    And I have done a lot of risk assessment, myself, during 
the time I served at EPA, and I am very comfortable with the 
use of animal data to determine risk. So I just think these 
    Mr. Shays. Then tell me why I should feel confidence that 
you used animal data?
    Dr. Goldman. Well, I think, first and foremost, that the 
reports stand on their own, in terms of citing the data, 
discussing the data, including the data in the discussions of 
the substances and the relationships to disease. And so, you 
know, we could step through them. And there are literally 
hundreds, if not thousands, of studies reviewed in those 
    You can also look at the composition, the members of the 
committee. We could point to those who are toxicologists, who 
were there to provide that expertise.
    Mr. Shays. OK.
    Dr. Goldman. No one member of any committee like this is an 
expert in all of the science that this kind of a group looks 
at. But we did have experts in the science of toxicology who 
were there to provide that.
    Mr. Shays. Well, you know, I have become inherently 
suspicious, without the background to back up my suspicion. And 
if you had been in my place for 14 years, you would be more 
suspicious than I am. And I become suspicious when I see a red 
herring like two pieces of legislation coming before me--
totally irrelevant.
    And I become suspicious because we all know that 25 
percent, give or take, of our veterans are sick. And they 
aren't getting any help. They are getting no help. They are 
getting no help.
    And so, I am struck by the fact, and I am going to have to 
say to you, your testimony is going to be--I mean no real 
disrespect, Dr. Mather, but we have had too many disagreements 
for me to feel comfortable with this side of the equation.
    Your testimony is going to stand as saying to us, in total 
confidence, that the first panel was totally wrong. Their 
statement was that animal studies were not considered; were not 
evaluated; they were ignored. And you are saying, ``Not so.'' 
That is what your testimony is saying to us.
    And if you want to carry that burden, I hope it is with 
total confidence; because I don't know you, but I am going to 
have to go with that. And that is the way.
    And if you have any bit of concern that maybe you didn't 
look at animal studies the way Congress intended, this is your 
chance to tell us. If you think you could have done a better 
job, this is your chance to tell us. Otherwise, it is going to 
be your statement. It is on your shoulders. And everything 
rests on what you say. That is why I am going to conclude this. 
That is where I am coming from.
    So if you want to be a little more precise, fine. If you 
want to have your testimony stand the way it is, that is the 
way it is going to stand.
    Dr. Goldman. Let me tell you how I think this connects 
together, and it might be helpful. I mean, first and foremost, 
can I sit here and say that I believe that I am an expert on 
what the intent of Congress was in these bills and that I know 
what all those intentions were? No, I can't say that. I cannot 
say that.
    Mr. Shays. OK, but let's stop there----
    Dr. Goldman. I am not an attorney and----
    Mr. Shays. No, let's stop there, though.
    Dr. Goldman. I cannot say that.
    Mr. Shays. No, OK. That is not really what I am asking.
    Dr. Goldman. OK. I just want to make that clear.
    Mr. Shays. Because what I am saying to you is, it was the 
intent--no one disagrees with it--that animal studies would 
have a huge weight. Because we know there is no other way to 
look at it. We don't believe that it is possible to provide any 
help to veterans if we don't look at animal studies, because 
there aren't any other real important studies of any 
consequence over a long period of time to rely on--given that 
we don't know the intensity of the exposures to our veterans.
    So we don't think you are going to experiment with human 
beings on exposures. So if you can't experiment on human 
beings, and you can on animals, animals are our only way, in my 
judgment, of coming to some conclusion.
    Dr. Goldman. I think that our committees may have been, 
from that dilemma, salvaged from that by the fact that the 
substances to which we were directed for our studies--without 
an exception that I can think of--have had extensive amounts of 
human epidemiological evidence to review; I mean, so much so 
that our committees were nearly overwhelmed by the amount of 
work that was required in order to go through even the human 
studies. We weren't looking at----
    Mr. Shays. Let me ask you something. Let's just take 
depleted uranium. Tell me the studies that you looked at of 
depleted uranium.
    Dr. Goldman. I did not serve on that committee, so I am 
going to have to defer that one to somebody else. I am not 
familiar with that report.
    Mr. Shays. So you can only speak to it as it relates to 
certain issues related to what?
    Dr. Goldman. The three reports that I have been involved 
    Mr. Shays. Refresh me again?
    Dr. Goldman. Yes. Let me make sure I am referring to them 
properly. The fuels, combustion products, and propellants 
report; and the insecticide and solvents report. And then, I am 
currently chairing the review of the medical literature report.
    Mr. Shays. So insecticides, we have a lot of studies from 
the workplace.
    Dr. Goldman. Yes. And that was true for solvents, as well. 
There were many studies.
    Mr. Shays. And how about Sarin?
    Dr. Goldman. Sarin?
    Mr. Shays. How many studies?
    Dr. Potolicchio. How many studies were actually reviewed?
    Mr. Shays. Yes.
    Dr. Potolicchio. I don't know the exact number. But I can 
tell you that in the first committee, there was a large body of 
toxicology studies with Sarin that were looked at, in depth. 
And as a matter of fact, there was a fairly long----
    Mr. Shays. Mixing----
    Dr. Potolicchio. We are talking about the first----
    Mr. Shays. Mixing Pyridostigmine Bromide in with it?
    Dr. Potolicchio. Exactly, and Sarin.
    Mr. Shays. Well, how? How would you do it with humans? Did 
we experiment with humans?
    Dr. Potolicchio. Well, the only experiments that you had in 
humans came from the Edgewood studies.
    Mr. Shays. No, I am talking just humans, though. I am not 
talking animals.
    Dr. Potolicchio. Edgewood was the only studies that you 
actually had measured exposure.
    Mr. Shays. That is the only study?
    Dr. Potolicchio. In humans.
    Mr. Shays. OK. And with depleted uranium, can you speak to 
    Dr. Potolicchio. Depleted uranium, there were quite a lot 
of studies that were evaluated there; but it was mainly in the 
miners, and so forth.
    Mr. Shays. With depleted uranium?
    Dr. Potolicchio. The uranium miners were looked at, 
    Mr. Shays. OK. All right.
    Dr. Potolicchio. They had to look at uranium in general 
before they made comments about depleted uranium.
    Mr. Shays. Yes, but that is a different substance. Depleted 
uranium is different. Uranium is the same. Depleted uranium is 
a hardened metal, correct, that was almost vaporized when they 
were hitting tanks. And when our soldiers went into these 
tanks, they breathed these hardened metal substances that were 
in extraordinarily fine pieces, correct?
    Dr. Potolicchio. That is correct.
    Mr. Shays. And we have a study of that kind of 
    Dr. Potolicchio. Well, they looked at the soldiers who, you 
know, had depleted uranium fragments in their body. And those 
studies are still ongoing, as I understand.
    Mr. Shays. No, I understand that. What I am trying to talk 
about is, there is no study that we can--we can't go to a mine 
and talk about depleted uranium. It is radiological, it is 
radioactive in that sense; but it is not the same substance, 
    Dr. Potolicchio. It is not the pure substance. But they did 
look at uranium miners, because they broadened it to encompass 
the whole thing.
    Mr. Shays. And they looked at the mixture of Sarin with PB? 
Where would they have found that?
    Dr. Potolicchio. No, there is no study that looks at the 
    Mr. Shays. See, that is my point. How do you duplicate 
that, where you mix the two? We absolutely know for a fact--
that when the alarms went off, the soldiers and others who were 
in the field panicked. They took out their PB and took--if they 
were supposed to take one, they took four. And they thought, 
``My God, if four protects me, I'll take eight.'' You know, 
there is no study to duplicate that.
    Dr. Potolicchio. No, there is no study.
    Mr. Shays. Yes. So if there is no study, I wonder how we 
are able to help those veterans, if we are not able to do 
animal studies. And so, you had witnesses before you. Speak to 
Dr. Henderson's research, if you could.
    Dr. Potolicchio. Well, her research has to do with the, you 
know, subtype of receptor in the brain that changes after 
exposure to low-dose Sarin.
    Mr. Shays. Combined with----
    Dr. Potolicchio. Combined with----
    Mr. Shays. PB.
    Dr. Potolicchio. With PB.
    Mr. Shays. Right.
    Dr. Potolicchio. No, well, I am not so sure she did that. 
Abou-Donia did that; not Henderson.
    Mr. Shays. OK. I think she mentioned that. See, I just 
don't know how we find that kind of experience, that data, in 
terms of our looking at humans. I think we only find it with 
    So in those studies, I am inferring from you, Dr. Goldman, 
that when she talks about those studies, in spite of the fact 
that she saw distortions, it wasn't the kind of distortions 
that would lead a committee to say there was a problem?
    Dr. Potolicchio. But you have to look----
    Mr. Shays. I am asking you, Dr. Goldman.
    Dr. Potolicchio. Oh, I'm sorry.
    Dr. Goldman. Well, in this, I would just have to be 
expressing my personal opinion, because I was not on the Sarin 
    Mr. Shays. Right. I understand that.
    Dr. Goldman. But my personal opinion about those studies is 
that they are exceedingly valuable, in terms of providing, if 
you may, kind of a biological marker that with these low doses 
there is something going on in the brain. And they are also 
highly innovative, because she is using low doses; and most 
animal studies don't do that.
    And I think that kind of research is heading in a direction 
where in future we are going to see animal studies that are 
going to be much more useful to us. You know, I said in my oral 
testimony that a lot of the animal studies are done at such 
high doses that it is hard to interpret them. But when I read 
her study--which, again, I was very impressed by--I don't think 
I would have been able to draw from it a disease outcome, a 
health outcome, in people from it.
    Even though it would make me extraordinarily concerned 
about the possibility of chronic effects from low-level 
exposures, I couldn't tell you what a patient with those 
effects might look like, on the basis of changes in receptors 
in certain parts of the brain and these other subtle findings.
    And if I had been on the committee, I think where I would 
have come down with that is, you know, one, wanting to see a 
lot more research on Sarin and, two, wanting to see a lot of 
effort made to make sure that in the future, where we have 
soldiers who might be exposed to Sarin, that we are out there 
monitoring it. I would love to see sniffers of some kind, or 
badges, or real-time monitors out there.
    Mr. Shays. You know, you are being the perfect scientist, 
and I respect it.
    Dr. Goldman. Not perfect. Not at all perfect.
    Mr. Shays. Well, no, but you are in a way. You would say--
    Dr. Goldman. No.
    Mr. Shays. No, hear me out a second. You want to see a lot 
more studies.
    Dr. Goldman. No, not a lot----
    Mr. Shays. No, no, that is what you did say.
    Dr. Goldman. But I don't think a lot----
    Mr. Shays. No, no, hold on. I am going to say it, and then 
you can respond.
    Dr. Goldman. Yes.
    Mr. Shays. I have given you an opportunity to respond.
    Dr. Goldman. OK.
    Mr. Shays. I am going to say to you that I have heard that 
for 15 years.
    Dr. Goldman. Yes.
    Mr. Shays. Fourteen years. And so the veterans are right: 
By the time we are going to be able to help them, they will all 
be dead. They will all be too old. That is the bottom line. 
Because you are being that scientist that we want you to be in 
one respect.
    We wanted, though, to bring it down a notch. We wanted to 
give a lot more weight to animal studies. You know, the worst 
thing that could be is, you might be wrong; and so you help 
some veterans who are sick. What a terrible thing to have done. 
In the end, that is what we would have asked you all to do.
    But I feel like the level is just set a little too high. 
That is kind of what I am struck with.
    Dr. Goldman. Well, let me try a response. And, you know, 
here are some possible ways that this could be approached. And 
one is to say, OK, the fact that there are these changes, these 
brain changes, in animals, but we don't know what the disease 
is--but we could maybe presume that it might be neurological. 
And this is a question, I think, that is back to Congress. Then 
would you say every neurological disease might then be somehow 
    I mean, as a scientist, I can't tell you what the diseases 
are. But that is something that would be a potential, and maybe 
not an irrational, response.
    Another possible response is to say, ``Could you somehow 
infer which veterans were more likely exposed to Sarin gas?'' 
and presumptively say, well, on that basis--we don't know what 
it might have done to them, but on that basis, say that they 
deserve to have some kind of compensation? Again, that is a 
different question than saying, can I tell you what disease is 
    Mr. Shays. No----
    Dr. Goldman. And you might be right that we have been 
approaching this with a scientific rigor, because we have 
thought that the question was a specific clinical condition 
connecting it to a specific exposure. That is really hard to do 
with those kinds of data. But there are other kinds of 
inferences that could be made. There are other ways to approach 
    Mr. Shays. What triggers me is when I hear that your immune 
system in animals is impacted. I mean, that is the kind of 
veterans we kept seeing. Weird things happen to them, weird 
things: rashes that were just unexplainable. But you could see 
it. They were really in bad shape. And then we have doctors, 
who I respected, say, ``You know, when you take certain 
chemicals, you impact your immune system in your brain, and 
tragic things can happen as a result.''
    Now, I want to be real clear here. I am going to invite Mr. 
Binns to just respond, but not in any way about who holds 
responsibility. I am just going to ask him to respond to the 
fact--Mr. Binns, if you are hearing me--to the fact that we had 
one whole panel that said one thing, and we have another panel 
who said another.
    I would like you to come up, please. If you would, just 
pull a chair on the side of the table.
    Your view is a view I share, so you are not alone; even 
though you may feel alone with this panel--that the animal 
studies carried very little weight. I am not interested in who 
holds responsibility, or any part of that dialog. So you may 
react to this panel.
    And then I am going to close by having you all just ask if 
there is any question we should have asked, any comments you 
want to make.
    Yes, sir.
    Mr. Binns. I think it is actually quite simple to reconcile 
the comments that have been made. No one has suggested that the 
IOM committees have not read a lot of animal studies, written a 
lot about animal studies, and presumably in their deliberations 
discussed animal studies. But the conclusions--which are the 
only thing that matters, under the law, for the determination 
of benefits--have all been expressed within the framework of 
the categories of evidence.
    Dr. Goldman suggested that the categories of evidence were 
reconsidered by each IOM panel. But--correct me if I am wrong--
have any panels changed the categories of evidence to include 
animal studies?
    Mr. Shays. Unless there is a ``Yes,'' I am going to assume 
the answer is ``No.''
    Dr. Goldman. The answer to the first part is ``Yes.'' And I 
just don't know about the answer to the second part of your 
question. I don't know.
    Mr. Shays. So the answer is that the criteria has changed; 
you just don't know where the criteria has changed. And the 
committee will look at it, so it is a valid point to bring up.
    Mr. Binns. OK.
    Mr. Shays. I mean, Dr. Goldman, am I expressing your view? 
    Mr. Binns. The copy of the categories of evidence I have 
from the first Gulf war report--and I do not have them from all 
of the reports. But for example, the ``limited, suggestive 
evidence of association'' which was referred to, it again is 
limited to exposure to a specific agent and a health outcome in 
    So it is not enough to say, ``We have contemplated animal 
studies,'' if at the end of the day the boxes that you have 
choices of checking are boxes which are defined in terms that 
exclude animal studies.
    Mr. Shays. Thank you. Is there any other point, before I 
get on?
    Mr. Binns. I would add one more point, and that is the 
reference to the effects in animals; that you couldn't know 
what these effects would be. I think Dr. Henderson testified to 
the fact that there were cognitive effects. So it is not 
entirely true to say that there are no judgments that can be 
made based on this evidence.
    And in fact, I think the doctor used the word 
``suggestive'' in discussing what he felt were the conclusions 
that could be drawn from Dr. Henderson's studies, and I would 
add, studies by the Chemical Defense Institute of the Army and 
others who have also found low-level effects of Sarin.
    ``Suggestive'' is the term that Dr. Goldman pointed out 
does meet what category three is supposed to be: ``Limited 
suggestive evidence of an association.'' So by their own terms, 
I would find that standard has been satisfied.
    Mr. Shays. Well, this is a work in process. But I don't 
think we can afford to have this issue just keep going on and 
going on and going on.
    I am going to invite all of you to just make any comment 
you make, or choose not to; or ask any question you choose to 
ask, and answer. Dr. Mather.
    Dr. Mather. Well, I really only want to apologize to you 
for confusing you with the stuff about the legislation, the two 
pieces of legislation. I certainly didn't mean to confuse 
anybody. But I am here representing, as you well know, the 
Department of Veterans Affairs, and people who know more than I 
do, perhaps, felt that was an important piece of background. 
But I apologize. I could have fought to keep it out.
    I also want to apologize and take responsibility for the 
fact that the Gulf War Veterans' Health Initiative has not been 
revised. It is on the list to be revised, and we recognize that 
it is out of date. And we certainly are working on a revision. 
But it simply hasn't been finished.
    Mr. Shays. Thank you for saying that. Dr. Brown.
    Dr. Brown. Thank you, Congressman. I want to thank you for 
inviting us here. I do appreciate the fact that you are 
persisting to push this issue. It is an obvious and an ongoing 
issue. It is very frustrating.
    And I guess, on a personal note, I would just add that, for 
me, to hear somebody like Mike Woods, who I have known for some 
time--to hear him talk about the problems he has had getting 
treatment and recognition of his illnesses from VA, really, it 
just breaks my heart. I am sorry. I am just so sorry to hear 
    Mr. Shays. Well, I would like you to followup----
    Dr. Brown. I think that I might--on a personal note, I 
think that I am going to--I mean, he is one veteran, but every 
veteran is an important veteran. I am going to talk to him.
    Mr. Shays. Well, thank you for saying it. But he testified 
that he was given a placebo.
    Dr. Brown. I can't explain that. I don't think that VA 
doctors would do that, but I will look into that.
    Mr. Shays. Thank you. Dr. Brown, I am going to ask you to 
look into it, and ask you to report back to me.
    Dr. Brown. Thank you, Congressman. I will. He also talked 
about having problems with getting a registry exam, and not 
being asked questions about his exposure; which is something 
that also concerns me, since it is also a program that my 
office is involved with. So, yes, I will make that commitment, 
sir. Thank you.
    Mr. Shays. And we appreciate your counsel being here. I 
realize, given the issue, you were here to respond to that 
issue. And I thank you for your honesty in response to my 
questions. So, thank you.
    Mr. Hipolit. Thank you, Mr. Chairman.
    Mr. Shays. Dr. Goldman.
    Dr. Goldman. Yes. I want to thank you for holding this 
hearing; and for your concern about the health and welfare of 
the veterans; and to say certainly I am available if there are 
further questions or discussions you want to have. I am sure 
that is true for the other scientists who served on these 
committees. And just to give you my assurance that, from what I 
can tell, that they are all committed to trying to do this job 
in the way that Congress has intended it to be done.
    And if we are not doing that, then we need to hear that. We 
need that feedback; and we need to be corrected, so that we are 
providing the kind of scientific information that you need in 
order to do your job. So thank you very much.
    Mr. Shays. Thank you, Dr. Goldman. Dr. Potolicchio.
    Dr. Potolicchio. Well, I would like to thank you for 
inviting me, also. And I am sure you are on top of this.
    Mr. Shays. Well, we aren't. That is the sad thing. We are 
trying to be.
    We didn't ask you to make any comments, so, you know, 
probably, you will have the greatest wisdom of the whole group 
right now.
    Ms. Stoiber. Absolutely not. But I do want to say that the 
Institute takes very seriously the privilege that we have been 
offered of doing this important work on behalf of veterans. The 
scientists who serve on our committees all serve pro bono, and 
they give thousands of hours of work for every committee. And 
so they do it as a matter of national interest and personal 
commitment to get the best possible and most accurate 
scientific outcome in every analysis.
    And so we listen to what you are saying, and we certainly 
will make every effort to assure that issues that you have 
raised are considered in any work that unfolds from this day 
    Mr. Shays. Thank you. You know, we give the benefit of the 
doubt, when bringing out a drug, to making sure we don't bring 
it out unless we are very certain that it is safe. It seems to 
me, we should be giving the benefit of the doubt to the 
veteran, in terms of the analysis that we make.
    Ms. Stoiber. If you could sit in on our committee 
meetings--which you can't, because they are all conducted in 
private, except for public sessions--you would hear the 
committee members really searching very hard on every shred of 
evidence to try to figure out if there are alternate 
interpretations; and if so, how to do so in a way that is in 
the interests of the veterans community. So we will do that 
conscientiously; but we already take it as a very important 
component of what we do.
    Mr. Shays. Thank you. Mr. Binns, we appreciate your staying 
through and listening to the whole--let me first say, I 
appreciate the government folks coming second. It gives me a 
feeling that you have more credibility, having heard what was 
said in the first panel. So I thank all of you for that.
    And I thank those on the first panel for staying and 
listening to what the second panel had to say.
    Do you have some nice closing comments you would like to 
    Mr. Binns. I wish I did. I think the people who met me 3\1/
2\ years ago know that I am a person who likes to assume the 
best and work with people; and we have tried that for 3\1/2\ 
    I also sat in on the first session of Dr. Goldman's new 
committee. As Dr. Stoiber was saying, you can't sit in on the 
detailed discussions. The speakers selected by the staff to 
participate in that session--which is the only session at which 
outside speakers were permitted--were not a balanced 
presentation of Gulf war illnesses work.
    And it makes it very difficult for me to believe that the 
people who have organized these programs--and I distinctly want 
to distinguish that from the scientists who have participated 
in them. And I respect that they do this out of their 
dedication to the country and out of their scientific 
dedication, and I do not wish to in any way impugn any of their 
    But they have been presented with a stacked program here, 
from the categories of evidence to, most recently, what was 
told them by the people selected to speak to them.
    Mr. Shays. Well, let me ask you, it is staffed by whom? It 
is staffed by not the Department of Veterans Affairs; is it?
    Ms. Stoiber. No. Our committees are staffed by professional 
staff of the IOM; many of them, sitting here with me today.
    Mr. Shays. Right.
    Ms. Stoiber. And they work under the direction of the 
committee. I think we organize information, but every single 
IOM committee has a great deal of independence to, in fact, 
approach the study and the agenda in any way they deem most 
    Mr. Shays. Let me just say, I wanted everybody to be honest 
with their feelings; so I appreciate Mr. Binns. I wanted him to 
say something positive, but he said what he needed to say.
    I would hope, though, that in the course of a presentation, 
that you are pretty comfortable that you are having a 
presentation that expresses what, for instance, this committee 
would have heard time and again. So I will make that point to 
you, and have confidence that you have confidence in the people 
who are doing this work.
    Let me say, I thank all of you for coming. And I thank you 
for your honest answers to my questions. You have tried to help 
us sort this out, and it is very appreciated.
    And I will just end with you, Mr. Binns, for your service 
in what I know has become very frustrating for you. And since I 
have experienced this, as well, and since I know how you feel, 
I particularly thank you for your service.
    With that, this committee is adjourned.
    [Whereupon, at 4:10 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record