[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
EXAMINING VA IMPLEMENTATION OF THE PERSIAN GULF WAR VETERANS ACT OF
1998
=======================================================================
HEARING
before the
SUBCOMMITTEE ON NATIONAL SECURITY,
EMERGING THREATS, AND INTERNATIONAL
RELATIONS
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/
index.html
http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
25-667 PDF WASHINGTON : 2006
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
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
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
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
LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of
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
Relations
CHRISTOPHER SHAYS, Connecticut, Chairman
KENNY MARCHANT, Texas DENNIS J. KUCINICH, Ohio
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida BERNARD SANDERS, Vermont
JOHN M. McHUGH, New York CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio CHRIS VAN HOLLEN, Maryland
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
----------
Page
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
EXAMINING VA IMPLEMENTATION OF THE PERSIAN GULF WAR VETERANS ACT OF
1998
----------
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
veterans.
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
studies.
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
follows:]
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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.
STATEMENTS OF MIKE WOODS, 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
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
it.
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
decline.
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
deserves.
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.
STATEMENT OF STEPHEN L. 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
service.
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'
illnesses.
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
important.
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
case.
Another disappointment was that there was no funding in
2005 for the much-needed, much-anticipated new study center for
treatments.
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
illness.
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
today.
[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
files.]
[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
you.
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
Illnesses.
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
today.
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
veterans.
[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.
[Applause.]
Mr. Shays. Excuse me. This is a hearing and, I am sorry,
applause is not allowed.
Dr. Henderson.
STATEMENT OF ROGENE 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
diagnose.
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
humans.
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
effects.
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,
correct?
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.
STATEMENT OF JAMES P. 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
earlier.
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
information.
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
statement?
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
question.
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
things.
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
question.
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
broken.
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
money.
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
site.
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
rats.
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
possibility.
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
compensation.''
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
it?
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
problem.
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
year.
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
communication.
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
best.
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
legally?
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
exposure.
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
question.
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
about?
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
of----
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
understanding.
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.
O'Callaghan?
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
``Placebo.''
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
hands.
[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.
STATEMENTS OF SUSAN MATHER, 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
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
do.
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
policies.
Thank you again for the opportunity to be here. My
colleagues and I will be glad to answer any questions you may
have.
[The prepared statement of Dr. Mather follows:]
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Mr. Shays. Thank you very much.
Dr. Goldman.
STATEMENT OF DR. LYNN 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
important.
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.
STATEMENT OF SAM 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
Hospital.
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.
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
Sarin.
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
controversial.
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
veterans.
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
studies.
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
effects.
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
inconsistencies.
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
described?
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
with.
Dr. Brown. OK, I take your point. That is a good question.
Mr. Halloran. So I don't find that persuasive evidence of
anything.
Dr. Brown. That is a good question. I guess I would answer
that by----
Mr. Halloran. What different did you do because of this
statute?
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
association.
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
suggestive.''
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
inapt?
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
result.
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
more.
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''
correct?
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
difficult.
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
why.
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.
Correct?
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,
please.
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
assessment.
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
are----
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
reports.
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
with.
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
that?
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,
particularly.
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
circumstance?
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,
correct?
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
mixture.
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
animals.
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
committee.
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
linked?
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
caused.
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
it.
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?
Right.
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
humans.
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
that.
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
forward.
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
make?
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\
years.
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
service.
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
appropriate.
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.]
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follows:]
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