[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
THE IMPLICATIONS OF THE U.S. DEPARTMENT
OF VETERANS AFFAIRS' LIMITED SCOPE OF
GULF WAR ILLNESS RESEARCH
=======================================================================
HEARING
before the
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JULY 30, 2009
__________
Serial No. 111-39
__________
Printed for the use of the Committee on Veterans' Affairs
COMMITTEE ON VETERANS' AFFAIRS
BOB FILNER, California, Chairman
CORRINE BROWN, Florida STEVE BUYER, Indiana, Ranking
VIC SNYDER, Arkansas CLIFF STEARNS, Florida
MICHAEL H. MICHAUD, Maine JERRY MORAN, Kansas
STEPHANIE HERSETH SANDLIN, South HENRY E. BROWN, Jr., South
Dakota Carolina
HARRY E. MITCHELL, Arizona JEFF MILLER, Florida
JOHN J. HALL, New York JOHN BOOZMAN, Arkansas
DEBORAH L. HALVORSON, Illinois BRIAN P. BILBRAY, California
THOMAS S.P. PERRIELLO, Virginia DOUG LAMBORN, Colorado
HARRY TEAGUE, New Mexico GUS M. BILIRAKIS, Florida
CIRO D. RODRIGUEZ, Texas VERN BUCHANAN, Florida
JOE DONNELLY, Indiana DAVID P. ROE, Tennessee
JERRY McNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia
Malcom A. Shorter, Staff Director
______
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
HARRY E. MITCHELL, Arizona, Chairman
ZACHARY T. SPACE, Ohio DAVID P. ROE, Tennessee, Ranking
TIMOTHY J. WALZ, Minnesota CLIFF STEARNS, Florida
JOHN H. ADLER, New Jersey BRIAN P. BILBRAY, California
JOHN J. HALL, New York
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
__________
July 30, 2009
Page
The Implications of the U.S. Department of Veterans Affairs'
Limited Scope of Gulf War Illness Research..................... 1
OPENING STATEMENTS
Chairman Harry E. Mitchell....................................... 1
Prepared statement of Chairman Mitchell...................... 47
Hon. David P. Roe, Ranking Republican Member..................... 2
Prepared statement of Congressman Roe........................ 48
Hon. John J. Hall, prepared statement of......................... 48
WITNESSES
U.S. Department of Veterans Affairs, Douglas E. Dembling,
Associate Chief Officer for Program Coordination, Office of
Public Health and Environmental Hazards, Veterans Health
Administration................................................. 36
Prepared statement of Mr. Dembling........................... 79
______
Goldman. Lynn, M.D., MPH, Professor, Bloomberg School of Public
Health, Johns Hopkins University, Baltimore, MD, and Member,
Committee on Gulf War and Health, Institute of Medicine, The
National Academies............................................. 4
Prepared statement of Dr. Goldman............................ 49
Haley, Robert W., M.D., FACE, FACP, Professor of Internal
Medicine-Epidemiology, Department of Internal Medicine,
University of Texas Southwestern Medical Center at Dallas, TX.. 21
Prepared statement of Dr. Haley.............................. 62
Hardie, Anthony, Madison, WI..................................... 25
Prepared statement of Mr. Hardie............................. 70
Research Advisory Committee on Gulf War Veterans' Illnesses,
James H. Binns, Chairman....................................... 7
Prepared statement of Mr. Binns.............................. 52
Steele, Lea, Ph.D., Adjunct Associate Professor, Kansas State
University School of Human Ecology, Manhattan, KS, and Former
Scientific Director, Research Advisory Committee on Gulf War
Veterans' Illnesses............................................ 9
Prepared statement of Dr. Steele............................. 57
White, Roberta F., Ph.D., Professor and Chair, Department of
Environmental Health, and Associate Dean for Research, Boston
University School of Public Health, Boston, MA................. 23
Prepared statement of Dr. White.............................. 68
SUBMISSIONS FOR THE RECORD
U.S. Department of Veterans Affairs, Joel Kupersmith, M.D., Chief
Research and Development Officer, Office of Research and
Development, Veterans Health Administration, statement......... 83
National Vietnam and Gulf War Veterans Coalition, Major Denise
Nichols, RN, MSN, USAFR (Ret.), Vice Chair, statement.......... 86
MATERIAL SUBMITTED FOR THE RECORD
Post-Hearing Questions and Responses for the Record:
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to Lynn
Goldman, M.D., MPH, Committee on Gulf War and Health, Institute
of Medicine, The National Academies, letter dated August 12,
2009, and response letter dated October 13, 2009............... 90
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to James H.
Binns, Chairman, Research Advisory Committee on Gulf War
Veterans' Illnesses, letter dated August 12, 2009, and response
letter dated December 12, 2009................................. 102
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to Lea Steele,
Ph.D., Adjunct Associate Professor, Kansas State University
School of Human Ecology, letter dated August 12, 2009, and
response memorandum dated October 12, 2009..................... 104
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Chairman, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to Robert W.
Haley, M.D., FACE, FACP, Professor of Internal Medicine,
University of Texas Southwestern Medical Center, letter dated
August 12, 2009, and response letter dated October 13, 2009.... 106
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to Roberta F.
White, Ph.D., Professor and Chair, Associate Dean of Research,
Department of Environmental Health, Boston University School of
Public Health, letter dated August 12, 2009, and response
letter dated October 13, 2009.................................. 117
Hon. Harry E. Mitchell, Chairman, and David P. Roe, Ranking
Republican Member, Subcommittee on Oversight and
Investigations, Committee on Veterans' Affairs, to Hon. Eric K.
Shinseki, Secretary, U.S. Department of Veterans Affairs,
letter dated August 31, 2009, and VA responses................. 118
THE IMPLICATIONS OF THE U.S.
DEPARTMENT OF VETERANS AFFAIRS'
LIMITED SCOPE OF GULF WAR
ILLNESS RESEARCH
----------
THURSDAY, JULY 30, 2009
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Oversight and Investigations,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:00 a.m., in
Room 340, Cannon House Office Building, Hon. Harry E. Mitchell
[Chairman of the Subcommittee] presiding.
Present: Representatives Mitchell, Walz, Adler, Hall, and
Roe.
OPENING STATEMENT OF CHAIRMAN MITCHELL
Mr. Mitchell. Good morning and welcome to the Subcommittee
on Oversight and Investigations of the House Veterans' Affairs
Committee. This is a hearing on the Implications of the U.S.
Department of Veterans Affairs' (VA's) Limited Scope of Gulf
War Illness Research. This meeting is held on July 30th. This
meeting will come to order.
I want to thank everyone for attending today's Oversight
and Investigations Subcommittee Hearing entitled, ``The
Implications of the U.S. Department of Veterans Affairs'
Limited Scope of Gulf War Illness Research.''
It has been upward 19 years since the United States
deployed nearly 700,000 servicemembers to the Gulf in support
of Operations Desert Shield and Desert Storm. When these troops
returned home, some reported symptoms that were believed to be
related to their service and possible exposure to toxins,
agents, and chemicals. However, the amount and combination of
these chemicals used during this period is unknown, and
conflicting research has created a real challenge for being
able to prove a veteran's symptoms resulted from service-
connection.
As a result, there are many veterans with undiagnosed
illnesses and multiple symptom illnesses relating to their
service in the Gulf War who are still suffering from chemical
agent exposure, and are finding themselves fighting the VA to
have Gulf War Illness recognized as a service for compensation.
As many of you know, in May of this year, this Subcommittee
held its first of a series of hearings to address this issue.
During that hearing we examined the impact of toxins and
pesticides used during the Vietnam and Gulf Wars. And with a
growing chorus of concern over the accuracy of existing
research, I believe it is time for us to take an in-depth look
at the scientific research surrounding Gulf War Illness
research.
Today's hearing will focus on how the current research is
progressing, including taking a closer look at the reports
offered from the Institute of Medicine, the IOM, and the
Research Advisory Committee, the RAC. In addition, the hearing
will examine the VA's role in treating Gulf War Illness.
There are few things that I would specifically like to
examine today. First, did VA and IOM meet Congressional
mandates and the essence of Public Laws 105-277 and 105-368 to
include animal and human studies, along with evaluating
diagnosed and undiagnosed illnesses? Second, were methodologies
used by the IOM equivalent in both Agent Orange and Gulf War
studies? And third, I would like to examine the methodologies
utilized in the production of the RAC report.
We have learned, and will continue to learn, that Gulf War
Illness research is a challenge, but a missing link appears to
be a lack of documentation of exposure and compounds that
exposed our veterans.
Additionally, we are waiting for science to bridge the gap
between self-reported illnesses and diagnostic evidence, just
as we did with Agent Orange veterans.
Our last hearing on this issue shed light on the fact that
we aren't doing enough for our Gulf War veterans and that they
continue to fight for what they deserve.
Today, I am hopeful that we will examine this issue with
open minds and get one step closer to a consensus amongst
Congress, VA, scientific bodies, and most importantly, our
veterans.
For today's hearing, we have brought experts from all
fields to discuss this important issue. I am hopeful our
panelists here today will discuss the merits of the RAC report
in comparison with IOM methodologies and the results of both,
as well as discuss the best course to ensure that this
important research will benefit veterans.
I am anxious to hear from the VA what actions they have
taken in response to the RAC report, and more importantly, how
the questions surrounding Gulf War research affect our veterans
and how the VA plan to move forward.
While I praise all of our panelists here today for the
research work they are doing on behalf of our Gulf War
veterans, we must find a way to give these veterans the answers
they have been looking for since returning home from theater
almost 20 years ago.
Before I recognize the Ranking Republican Member for his
remarks I would like to swear in our witnesses. I would ask all
witnesses from all three panels to please stand and raise your
right hand.
[Witnesses sworn.]
Thank you. I would now like to recognize Dr. Roe for
opening remarks.
[The prepared statement of Chairman Mitchell appears on p.
47.]
OPENING STATEMENT OF HON. DAVID P. ROE
Mr. Roe. Thank you, Mr. Chairman, for yielding time.
As you indicated in your opening statement this is the
second of a three-part series of Gulf War Illness research. The
focus entitled to this second hearing is Implication to VA's
Limited Scope of Gulf War Illness Research. While I am not sure
that the VA has limited scope in the area of Gulf War Illness
research, I appreciate you calling this hearing to further
evaluate the research that has been completed and reviewed, not
just by the Research Advisory Committee on Gulf War Veterans'
Illnesses, but also by the National Academy of Science and the
Institute of Medicine. I understand that both organizations are
represented here today as witnesses.
As a follow up to our first meeting, we have received
responses to questions for the record from Dr. Roberta White
from Boston University, Dr. Lea Steele from Kansas State
University, Paul Sullivan of Veterans for Common Cause, as well
as the VA. I appreciate that we received their responses prior
to today's hearing. Their input from the last hearing is
important information that we have to process today.
On Tuesday afternoon, the Committee also received the
Secretary's ``Annual Report to Congress on Federally Responsive
Research on Gulf War Veterans' Illnesses for 2008.'' This
report is also important for us to review as it reflects the
large body of work that is continuing on this matter.
In fiscal year 1992 through fiscal year 2008, the VA, the
U.S. Department of Defense (DoD), and the U.S. Department of
Health and Human Services (HHS) funded 347 distinct projects
relating to health problems affecting Gulf War veterans. As of
September 30, 2008, 288 of these projects were completed, and
59 projects were either new or ongoing. I am pleased to have
received this report prior to today's hearing.
I am looking forward to a lively discussion today, as we
have representatives here from several different scientific
backgrounds representing different studies on Gulf War Illness
and possible causes.
I am pleased, Mr. Chairman, that you have decided to
include in this hearing the Institute of Medicine
representatives who have compiled large volumes of material on
Gulf War Illness, possible causes, and comorbid diseases, which
may or may not have come from exposure during the first Gulf
War.
I am interested in learning whether these same exposures
were also present during the current conflict and what we can
expect as the authorizing Committee, as to new presumptions for
exposure in both conflicts.
I would like to remind my colleagues as we proceed that we
must, throughout this series of hearings, keep an open mind as
to the reports and studies being presented to us, and the way
ahead for us as the authorizing Committee for benefits and
services provided to our Nation's veterans.
Again, Mr. Chairman, I appreciate your diligence in
pursuing these hearings, and yield back my time.
[The prepared statement of Congressman Roe appears on p.
48.]
Mr. Mitchell. Thank you. Mr. Walz, would you care to make
an opening statement?
Mr. Walz. No, Mr. Chairman, thank you again, and thanks for
the Ranking Member for holding this hearing.
Mr. Mitchell. Thank you. I ask unanimous consent that all
Members have 5 legislative days to submit a statement for the
record. Hearing no objection so ordered.
If the first panel would please come forward. Joining us on
the first panel is Dr. Lynn Goldman, Professor at the Johns
Hopkins University Bloomberg School of Public Health. She is
also a Member of the Committee on Gulf War and Health at the
Institute of Medicine of the National Academies. Dr. Goldman is
accompanied by Robbie Wedge, Senior Program Officer at the
Institute of Medicine. Also joining us on the first panel is
Jim Binns, Chairman of the Research Advisory Committee on Gulf
War Veterans' Illness, and Dr. Lea Steele, Former Scientific
Director of the Research Advisory Committee on Gulf War
Veterans' Illness and Adjunct Associate Professor at the Kansas
State University School of Human Ecology.
I want to remind all panelists if they could please keep
their statements to 5 minutes. Your complete written statement
will be submitted for the record. And I would like to recognize
in this order first Dr. Goldman, then Mr. Binns, and then Dr.
Steele. Dr. Goldman?
STATEMENTS OF LYNN GOLDMAN, M.D., MPH, PROFESSOR, BLOOMBERG
SCHOOL OF PUBLIC HEALTH, JOHNS HOPKINS UNIVERSITY, BALTIMORE,
MD, AND MEMBER, COMMITTEE ON GULF WAR AND HEALTH, INSTITUTE OF
MEDICINE, THE NATIONAL ACADEMIES; ACCOMPANIED BY ROBERTA WEDGE,
M.S., SENIOR PROGRAM OFFICER, BOARD ON THE HEALTH OF SELECT
POPULATIONS, INSTITUTE OF MEDICINE, THE NATIONAL ACADEMIES;
JAMES H. BINNS, CHAIRMAN, RESEARCH ADVISORY COMMITTEE ON GULF
WAR VETERANS' ILLNESSES; AND LEA STEELE, PH.D., ADJUNCT
ASSOCIATE PROFESSOR, KANSAS STATE UNIVERSITY SCHOOL OF HUMAN
ECOLOGY, MANHATTAN, KS, AND FORMER SCIENTIFIC DIRECTOR,
RESEARCH ADVISORY COMMITTEE ON GULF WAR VETERANS' ILLNESSES
STATEMENT OF LYNN GOLDMAN, M.D., MPH
Dr. Goldman. Thank you very much, Mr. Chairman, and thanks
also to Mr. Roe and the Members of the Subcommittee for holding
this hearing today on your concerns about veteran's health.
As you know my name is Lynn Goldman, and I am a professor
of environmental health sciences and epidemiology at the Johns
Hopkins University, and I did also serve in government for 6
years as assistant administrator for EPA's Office of
Prevention, Pesticides and Toxic Substances. But in this
regard, I have chaired two of the Institute of Medicine Gulf
War and Health Committees. One of the books here is our report
on ``Gulf War and Health: Review of the Medical Literature
Relevant to Gulf War Veterans Health,'' and another is our
report on fuels, combustion products, and propellants. Also, I
was a member of the committee that produced the report on
insecticides and solvents. And so I am here because of my
experience as a volunteer. Also, I am a member of the Institute
of Medicine.
I am going to focus on four points:
First, the overall process that the Institute of Medicine
uses for these studies and how these reports are reviewed.
Second, how these IOM committees have determined whether a
given agent might be related to a given health effect, relevant
to both the Gulf War and the Agent Orange studies that have
been conducted.
Third, how these scientific studies incorporate the
published literature, including animal studies, in the reviews.
Fourth, how what we know about exposures in the Gulf War
might affect our reviews.
So let me begin with study process. I think that you are
well aware of the fact that the IOM is a division of The
National Academies, that it is a non-governmental institution
that was chartered by Abraham Lincoln to provide independent
scientific advice to the Nation, and that the IOM assembles
volunteers who produce consensus reports that are highly
scholarly in nature.
In the case of these particular reports, the expertise that
would be brought together would be medical experts and
toxicologists, people who know about the substances, know about
the illnesses, and understand the animal studies that are
relevant to this. These members come from universities and not-
for-profit institutions, and they are balanced in terms of
being free of biases and conflicts of interest.
Our work is completely independent of the agencies that
sponsor this work. They are not allowed to participate in the
work or have access to the work. If we do ask them for
information that has to be given publicly. Everything has to be
out in the open.
So what does a committee do? We review all the relevant
literature we can find, we work toward reaching consensus about
conclusions, and we draft a report. The Institute of Medicine
has a very complicated peer review process with oversight by an
external team. I, as the chair of the committee, would have had
nothing to do with that process. Another group brings in a
variety of experts who review the report and provide comments.
Then those comments are returned to the committee. Each comment
has to be addressed. Finally, somebody who is independent of
our process has oversight over the process to assure that the
committee has responded to comments before the report is
finalized and made public.
So this is a very extensive process of peer review. At no
point during that review process is the sponsor given any
access to or allowed to affect either the analysis or the
conclusions of the report.
Each Committee has its own way of working. In terms of the
Gulf War and the Agent Orange reports, there are two guide
posts that these Committees have used. One is the statements of
work that are given to the IOM by the sponsoring agency, in
this case the VA. The second is the legislation. Certainly in
the case of committees I chaired, at each and every meeting we
would review both of those, because they are important guides
to the direction we should go.
How do we develop categories of evidence? Generally these
committees have used five categories, such as sufficient
evidence of a causal relationship, extreme for an association,
limited suggestive evidence of an association, inadequate
insufficient evidence to determine an association, and limited
or suggestive evidence of no association. These categories have
come about through the practice of scientific bodies over the
years, not only by the Agent Orange committees, but also by a
group called the International Agency for Research on Cancer.
These are ways that scientists can organize our thoughts
through a lot of criteria for deciding if a relationship is
causal.
One thing that has been misunderstood is how the criteria
that they have evolved over time. In the Gulf War studies, for
example, a new category of sufficient evidence of a causal
relationship was introduced. This category is important. For
example, you know that fire trucks are associated with fires,
but not because they cause fires. In reviewing scientific
evidence, we need to look at chains of events, to understand
causal chains look at what precedes an adverse event so that we
can make a determination of causality as opposed to
association; things that occur together are not necessarily in
a causal chain. In science there are specific ways that this is
done.
Another thing that I think has been confusing has been the
role of human versus animal studies. In this context, we
realize that a phrase that has been introduced in some of these
studies, ``in human studies,'' has been misunderstood.
Basically, when we talk about a causal association and when we
are looking at human evidence, we want to make sure that the
association isn't due to factors like chance, bias, or
confounding. Because epidemiology studies are rife with those
problems. And so where the criterion says that causality will
be determined on the basis of whether in epidemiology not due
to chance, bias, and confounding, some people have findings are
taken that to mean, therefore, IOM committees are not looking
at animal studies. That is not true. And all of these reports
have included examination of relevant animal studies, these
studies have been given weight, and there have been experts on
these committees that are very knowledgeable about these
studies.
Each and every animal study hasn't been reviewed and every
report because some of these chemicals, for example, Benzene,
have thousands of animal studies. For Benzene has a chapter in
every toxicology textbook; we know a lot about Benzene and we
can summarize all of that. We don't have to go back and read
every single study that is been conducted over the last 50
years on Benzene to know what Benzene does both to animals and
humans. And so there is also some judgment involved in terms of
which studies are reviewed, how they are included, and the
value of the information that is provided by those individual
studies is a part of this process.
And the last point I want to make has to do with the
exposures in the Gulf War and how that has affected all of the
work of these committees. The legislation lists a number of
chemicals and biological agents that the IOM was asked to
consider, not because there was any specific evidence of how
many people might have been exposed to those, but because it
was known that those had been used in the Gulf, had been in the
arena, and there was some potential for human exposure. No one
committee could review all of those substances. So the IOM held
some meetings with veterans to try to identify the agents about
which they were concerned, and then developed a process to
prioritize those for review.
But this issue of exposure has continued to be a problem.
This is not like Agent Orange, where you can go back years
later and find traces of dioxins in people's bodies. Among the
substances that we reviewed, most are fleeting; they do not
leave an imprint that today we can identify. Maybe some day we
will, but today we don't have a way of testing whether you were
exposed to particulate matter from an oil well fire 20 years
ago. Oftentimes, the studies that we reviewed could not provide
clear evidence. For example, a soldier might know that they had
a vaccination, but they don't know what it was. And, even if
they know which vaccination it was, they don't know which lot
it came from. But these are the kinds of things that we want to
know when we do epidemiology. The records may be there
somewhere, but they haven't been in a place where
epidemiologists have been able to use them.
And for some of the potential exposures, such as, for
example, the bombing and the fire that happened at the Sarin
gas plant fire, we have only been able to use models to
understand what the exposures might be. It is very difficult to
model a fire where you don't know the quantity of the material
that was there and you don't know the temperature at which it
was burning. You have some information about the weather and
the wind speed and so forth, but some of the basic parameters
for modeling are missing. And so it is very difficult to
determine what the exposures may have been.
The bottom line is although these committees have looked at
the health effects of potential exposures as charged by
Congress, it is very difficult because of the lack of real
exposure information for any scientific body to use to make
firm cause-and-effect conclusions about exposures to
individuals or even groups of individuals in the context of
specific health outcomes.
Last, I should mention that there is an updated review of
the literature on Gulf War veterans that is under way at the
IOM. I don't know very much about it, I am not involved with it
personally. Again, I would like to thank you for the invitation
to talk to you today. Thank you very much.
[The prepared statement of Dr. Goldman appears on p. 49.]
Mr. Mitchell. Thank you, Dr. Goldman.
Mr. Binns.
STATEMENT OF JAMES H. BINNS
Mr. Binns. Thank you, Chairman Mitchell, Ranking Member Roe
and Members of the Committee.
The Research Advisory Committee on Gulf War Veterans'
Illnesses is a public advisory body of scientists and veterans
mandated by Congress and appointed by the Secretary of Veterans
Affairs.
In a moment you will hear from Dr. Steele how the
committee's approach to reviewing the science in its 2008
report differed from that used in the Institute of Medicine
reports. I will discuss the legal background of the reports.
It is important to understand that neither the Research
Advisory Committee report, nor the Institute of Medicine
reports, are original research. Both of them are summaries--
reviews of what others have done.
And the reason the IOM is involved in this subject is
because in the same law that established the Research Advisory
Committee, Congress directed VA to contract with the IOM to
prepare reports to guide the Secretary of Veterans Affairs in
determining Gulf War veterans' health and disability benefits.
Now Congress was very specific as to how it wanted these
reports done. Congress directed VA to have the IOM review the
scientific literature for 33 hazardous substances to which
troops were exposed in the war to see if any of these
substances were associated with an increase risk of illness.
That is not a cause that is associated with an increase risk of
illness, that is what the law required.
If there was sufficient evidence of an association--again,
not a cause, an association--the Secretary of Veterans Affairs
was directed to prescribe a presumption of service-connection
for Gulf War veterans' benefits. Because most studies of
hazardous substances are done in animals, the law required that
both human and animal studies be considered in reviewing this
association specifically. And because Gulf War veterans'
illnesses often do not fit conventional diagnosis, the law
required that undiagnosed illnesses should also be considered.
In addition, because veterans were often exposed to
combinations of substances, the law required that the report
should consider combinations of exposures, yet the IOM reports
themselves state ``Only evidence from human studies was
considered, combinations of exposures were not considered, and
undiagnosed illnesses were not considered in reviewing whether
there was a sufficient association.''
The result is that the committees of scientists who worked
on the IOM reports were attempting to put together a puzzle
that was missing half the pieces. Most of these scientists had
no idea they were not following the law, I am sure. They were
undoubtedly told that they were following standard IOM
methodology. The Gulf War reports state that the methodology
comes from earlier IOM reports ordered by Congress related to
Agent Orange exposure in Vietnam. However, a close examination
shows that the Agent Orange methodology was subtly changed in
the Gulf War reports. One word, the word ``human'' was inserted
in the definition of whether there is sufficient evidence that
a substance is associated with an increased risk of illness.
The effect of this change is that animal studies were not
considered in the conclusion that governs the presumption of
service-connection, even though the law specifically required
them to be considered in that conclusion by both the IOM and
the Secretary. Whether they were considered elsewhere in the
reports, and they were, is of no consequence.
As to how that could have occurred, I would refer you to my
written testimony which includes correspondence between VA and
IOM staff prior to the start of one of the reports. These
documents show that discussions between VA and IOM staff placed
conditions on the report that predetermined its outcome before
the IOM committee to prepare it was ever appointed.
Today I am pleased to report that the VA official involved
in those discussions has recently left VA. I am also encouraged
that the new Secretary of Veterans Affairs is manifestly
committed to transforming the culture at VA headquarters to
better serve veterans.
So I hope that change is on the way, and look forward to
the testimony of the Department of Veterans Affairs this
morning. Change is sorely needed.
I have worked for three previous Secretaries of Veterans
Affairs, all honorable men, but have sadly seen VA staff
continue to minimize the serious health problems of Gulf War
veterans. Because of the stature of the IOM, its reports have
misled not only the secretaries of Veterans Affairs, but also
researchers, doctors, Congress, veterans' families, and
veterans themselves.
In December, VA ordered a new IOM report to review the
report of the Research Advisory Committee. Thus after waiting
18 years for VA to acknowledge that they are ill due to toxic
exposures, Gulf War veterans are now waiting for a committee
that has not reviewed all the evidence to review the report of
a committee that has. Recognizing the impossibility of this
task, IOM staff have stated that its committee will not review
the RAC report, but VA continues to say that it will.
What is clear is that the VA IOM relationship is in urgent
need of reform. The Institute of Medicine is the high court of
American medical science. Manipulation of its processes by the
government is a serious breach of public trust with
implications far beyond this subject.
[The prepared statement of Mr. Binns, appears on p. 52.]
Mr. Mitchell. Thank you. Dr. Steele.
STATEMENT OF LEA STEELE, PH.D.
Dr. Steele. Thank you. Good morning, I am Dr. Lea Steele, I
was asked to testify this morning on the differences between
the IOM's Gulf War reports and the report of the Research
Advisory Committee on Gulf War Veterans' Illnesses, or the RAC.
I was previously scientific director of the RAC and I
oversaw the Committee's review of the research for this report.
As you know, many veterans returned from the 1991 Gulf War with
symptoms that weren't explained by medical or psychiatric
diagnoses. This problem has been called Gulf War syndrome,
undiagnosed illnesses, or just Gulf War Illness. It is
important to distinguish this undiagnosed illness problem from
diagnosed diseases like cancer or diabetes.
Gulf War Illness refers specifically to this complex of
symptoms. Typically a combination of chronic headache,
difficulties with memory and concentration, widespread pain,
and other abnormalities that occur together as a multi-symptom
condition.
To begin, I will just briefly remind you of some of the
major findings of the RAC report. Based on a detailed analysis
of nearly 2,000 studies and reports the RAC concluded that
evidence clearly indicates that Gulf War Illness is real, that
it affects at least one in four veterans of the 1991 Gulf War,
and that few veterans have recovered over time.
The evidence most consistently points to two primary
causes. First, a small white pyridostigmine bromide pills or
PB, that was given to protect troops from the affects of nerve
agents. And second, pesticides which were used in large
quantities during the war. Several other factors like low level
exposure to nerve agents could not be ruled out as contributing
to this problem. Studies consistently show that Gulf War
Illness was not caused by psychological stress or being in
combat.
We also reviewed the evidence of other types of health
problems, only a few diagnosed conditions have been linked with
Gulf War service. Although serious, these conditions affect
relatively few veterans. The biggest problem by far is the
undiagnosed Gulf War Illness problem.
The differences between the RAC report and the IOM reports
are not subtle, and they are not explained by minor variations
in our review methods or how individual studies were considered
or weighted. Rather they reflect major differences in the types
of questions addressed by the two reports and the scope of
evidence that was used to answer those questions.
I can illustrate this by comparing the RAC and IOM findings
on PB, the anti-nerve gas pill. PB was widely used by the
military only in the 1991 Gulf War. Based on multiple sources
of evidence, the RAC found that PB was causally associated with
Gulf War Illness; in other words, it is one of the causes of
Gulf War Illnesses. This evidence includes studies of Gulf War
veterans that provide unambiguous results. All six studies
indicated that PB was significantly associated with Gulf War
Illness. Studies also found a dose response effect. That is,
veterans who took PB for a week or longer had higher rates and
more severe illness than veterans who took less PB.
We also considered results from animal studies showing that
repeat low dose PB exposure over a sustained period produced
brain effects that are not seen with brief or single dose PB
exposure.
PB's association with Gulf War Illness is also consistent
with what investigations tell us about the patterns of PB use
during the war.
So all of these different types of evidence are consistent,
and combined they support a clear association between Gulf War
Illness and PB, and especially prolonged use of PB.
The IOM report on the other hand found that PB is
associated with short-term effects, but there was insufficient
evidence to determine if it is associated with long-term
effects.
IOM's findings were based largely on clinical research in
humans, which generally studied effects of PB taken over a
short period, not more than a few days, and had no long-term
follow up. Their findings did not consider the many studies of
Gulf War veterans or the other PB research I mentioned.
IOM findings did not address in PB is associated with
undiagnosed illness, and this was true for most exposures
evaluated by IOM. Findings considered only limited types of
evidence and did not specifically address if the exposure was
associated with health problems that are found in Gulf War
veterans.
My written submission lists 12 general types of research
that the RAC considered in its findings. The IOM findings
relied in large part on just two of these categories of
evidence. The other types were not considered by IOM or just
considered in a very limited way.
For example, the hundreds of detailed epidemiologic
findings on associations between Gulf War Illness and Gulf War
exposures were scarcely considered by IOM. And as Mr. Binns has
indicated, IOM findings did not take into account results of
the many animal studies of exposures and combinations of
exposures.
IOM also made little use of the many government
investigations of exposures. For example, the report from DoD
on over 60 different pesticide products used by Gulf War
personnel concluded that at least 40,000 troops were
overexposed to pesticides in theater.
Now aside from these global differences, there are many
specific differences in the evidence considered. For example,
on the question of how many Gulf War veterans have been
affected, the RAC report found, based on findings in 6 out of 7
studies, that between 25 and 30 percent of Gulf War veterans
have a defined pattern of multi-symptom illness over and above
the background rates found in comparison groups. IOM findings
indicate an excess of just 13 percent, about half, based on
results from just one of the seven studies.
Another example relates to a highly publicized IOM finding
that there is no unique Gulf War Illness. This has been widely
misinterpreted to indicate that there is no Gulf War Illness
problem at all or that there are just random symptoms in
different veterans.
The RAC report examined the many studies that showed a
consistent pattern of symptomatic illness in diverse groups of
Gulf War veterans, and it concluded that Gulf War Illness is
unquestionably a real and definable problem, whether or not it
is considered unique from different perspectives.
So now returning to the big picture. What are the actual
implications of these differences? Are they really important?
Based on our review of the research, I believe they are.
The IOM Gulf War and health reports were intended by
Congress to be an authoritative assessment of evidence on both
diagnosed and undiagnosed health problems in Gulf War veterans,
and specifically to determine if these problems are associated
with the many exposures in the Gulf War. But IOM's reports do
not provide findings of that type, and they could not based on
the evidence considered.
In particular, government officials who rely on IOM
findings will know very little about the undiagnosed, but
widespread problem of Gulf War Illness, its characteristics,
its impact on veterans, and its relationship to exposures
during the Gulf War.
In short, the major differences between findings of the IOM
reports and the RAC report are not because the RAC and IOM
reviewed the same studies, but came to different scientific
conclusions about the evidence that result from major
differences in what evidence was considered and what questions
were addressed. Thank you.
[The prepared statement of Dr. Steele appears on p. 57.]
Mr. Mitchell. Thank you. Let me just ask very quickly, and
maybe it is more appropriate for another panel. Is there a use
for PB today? What is PB used for?
Dr. Steele. PB, it is a drug that is used for myasthenia
gravis, it has been used since the fifties. During the Gulf War
it was not approved by the Food and Drug Administration (FDA)
yet for use as an anti-nerve gas pill, it was given an
investigational drug approval just specifically for the Gulf
War. Since that time, it has been approved for use as an anti-
nerve gas agent against one nerve agent called Soman, but that
nerve agent was not present in the Gulf War.
Mr. Mitchell. Thank you. Does each Committee believe that
our veterans are suffering from a multi-symptom illness that is
commonly referred to as Gulf War Illness? Dr. Goldman.
Dr. Goldman. Yes, the Committee I chaired that wrote Volume
IV did conclude that, and concluded that the rate of such
multi-symptom illnesses among Gulf War veterans is much higher
than the rate among people who were deployed at the same time
who were not in the Gulf.
Mr. Mitchell. Okay. And the RAC?
Dr. Steele. Most definitely
Mr. Mitchell. Okay. Dr. Goldman, what do you see as the
difference in the conclusions, not the process or methods,
between the IOM report and the Gulf War on Health Volume IV and
the health effects of serving in the Gulf War and the RAC
report? So not the difference in conclusions, the methodology
or methods.
Dr. Goldman. What I think is the most important difference,
is that the RAC felt very strongly that they could prove a
causal association between PB and the Sarin gas exposures and
multi-symptom illness. If you look collectively across these
IOM reports you would not see such a conclusion.
Mr. Mitchell. And this was mentioned in both of them. In
your testimony, Dr. Goldman, you stated that inserting the word
``human'' into the association of evidence was used as a
clarifier.
Dr. Goldman. Correct.
Mr. Mitchell. Was there some reason or confusion about the
Agent Orange findings since the word ``human'' was not inserted
in those reports? And does this take away from the scientific
word of the study?
Dr. Goldman. Well the Agent Orange committees did not have
a category of association for causality. For determining
causality, we have in epidemiology the set of postulates that
we use called the Bradford-Hill criteria that the association
needs to be met before we say it is cause-and-effect. There are
a lot of findings in epidemiology that are associations but
that aren't actually cause-and-effect. So when that category
``causality'' was added, that is when Committees said, that for
human studies we need to make sure that it is not a result of
chance, bias, and confounding.
Now, I have here one of the reports that I was on, on fuels
and combustion products. This is the chapter where the animal
studies reviewed. And I can show you these reviews, chapter
after chapter. So when I hear in testimony that these
committees did not review animal studies and when I chaired and
served on some of these Committees and I can show you in these
books that were published years ago that these studies were
reviewed, I think that there may simply be a disagreement here
about that. Because the animal studies certainly were reviewed
for these reports.
Mr. Mitchell. Would either one of you like to comment on
that?
Mr. Binns. Yes. I have a page here from Gulf War on Health
Volume I, page 72, that is this one, and it states, ``For its
evaluation and categorization of the degree of association
between each exposure and a human health effect, the Committee
only used evidence from human studies.'' So for that assessment
of the degree of association, the Committee only used evidence
from human studies.
The requirement in the statute does not state that
causality needs to be showed. Yes, our report did go so far as
to say we felt it was causal, but the issue here is whether the
IOM followed the statute. The statute does not require
causality. It says, ``That the Secretary should make a
determination whether there should be service-connection based
on whether there is evidence that a positive association exists
between exposure of humans or animals and the occurrence of a
diagnosed or undiagnosed illness in humans or animals.'' It is
very clear, and it is just for an association.
And it further states, and this is from the law, ``An
association between the occurrence of an illness in humans or
animals and exposure to an agent, hazard, medicine, or vaccine
shall be considered positive for the purposes of this
subsection if the credible evidence for the association is
equal to or outweighs the credible evidence against the
association.''
So even a tie goes to the veteran if the evidence were
equal. And if there is any evidence over that it definitely
triggers a presumption. It does not require causality. It has
nothing to do with the Hills postulates.
Dr. Goldman. Actually the Committees read the law the same
way that Mr. Binns just cited, and those were the discussions
we had at the beginning of every Committee meeting. But one
sentence has been taken out of context. If you look at the
paragraphs that that sentence is a part of there is a lot of
explication of how animal studies were reviewed. In Volume I--I
was not on that Committee--you can see descriptions of the
studies and they say, ``that the Committee used animal and
other non-human studies, particularly as a marker for health
effects that might be important for humans.'' The remainder of
the paragraph goes on and on about how that was done.
Now you can't ask a dog about a headache. So for conditions
that are based only on symptoms, you are going to have trouble
elucidating much about those from animal studies. However, you
can find out a tremendous amount about how substances are
absorbed and what they are doing. There is no group of
scientists who would ever say we should ignore information. It
is just that you can't make a conclusion about symptoms because
you can't ask animals about symptoms. But there is no way that
annual studies were ignored by these Committees.
Mr. Mitchell. Thank you. My time has expired.
Dr. Roe.
Mr. Roe. Thank you, Mr. Chairman. Obviously this is a very,
very complicated issue, and you will excuse me, since last
night I didn't read all of the material. I did get through a
lot of the material. And I don't know how we are ever going to
come to a conclusion here because of what Dr. Goldman has said,
and she is correct. And Mr. Binns, I know you are going
straight to the law.
When you are looking at science and you use animals, and I
have done scientific research, we can cure cancer in animals,
in mice, but it doesn't work in humans. So you have to use
both, I agree with that, you can find out. And as Dr. Goldman
said, when you are doing animal research, you can't very well
go to a human and say let me draw the chemicals out of your
brain, which you can do to a mouse or a rat or whatever in the
lab.
So it is going to be impossible to ever, I think, because
you don't know what the exposure was. And I read in here
somewhere where the military, the DoD, didn't even know what
immunizations were given to the troops when they went. I find
that astonishing to me that you could go. Although I remember
when I got mine going in the service, probably like most guys,
and now women, you just lined up in a line and they fired away,
and if you happened to have a shot record you got it with you,
and I have no Earthly idea what happened to mine. So I can
understand why a soldier wouldn't know what immunization they
were given.
Do you think it would be a benefit to have a third party,
although it may not at this point, to look at the two
conclusions that were drawn? Because I know in work I have
done, sometimes I thought I was going one way and ended up
another.
And Mr. Chairman, when you don't know how much--like in the
case of Sarin gas--how much someone got, there is no way to
ever know. There is not any way you are going to draw a
conclusion. Would you all comment on that, please?
Dr. Goldman. My personal view, and this is not necessarily
the view of the IOM or anyone of its Committees, is that there
needs to be a re-examination of how that whole scheme has
worked in terms of the law, and the idea of service-related
illness, as well as the hurdles that the veterans have had to
leap over in order to be able to document service related
illnesses and what they have had to do in order to receive the
services that they need.
It might make sense to take all the IOM's Gulf War
conclusions, and look at what the VA has done with them and how
this work has or has not actually benefited the veterans.
Because I think at the end of the day, that is the critical
issue, not the subtle differences in the way these Committees
might have reviewed these studies, but what can be done to
actually benefit the veterans and their health I think that is
the major issue.
Mr. Roe. And Dr. Steele has been very, very clear, I mean I
listened to her testimony now twice, and she believes that PB--
and again, I should have done this last night but didn't--you
don't see many myasthenia gravis patients, it is a pretty rare
condition. But have you looked at the PB effects in that, Dr.
Steele? Has anybody done that?
Dr. Steele. Sure. The side effects--the acute side effects
in myasthenia gravis patients are similar to what we saw as
acute side effects during the Gulf War when people took the PB.
The issue is though that myasthenia gravis patients are
severely deficient in their acetylcholine mechanisms, and so
they take the PB in order to restore, you know, a higher level
of acetylcholine so that they can be normal. That is not the
case in healthy young soldiers. They don't need to have their
acetylcholine restored. And so the effects that we see in
myasthenia gravis patients are quite different in terms of the
biology of it.
So although, you know, the acute side effects are similar
in the two groups, the long-term use of PB in myasthenia gravis
does not tell us much about the long term use in healthy
people. And we do have studies of that.
Mr. Roe. Yeah, just one quick question before my time
expires. Dr. Goldman, is there any reason why--I mean, Dr.
Steele and the RAC Committee is very--they think that PB is the
cause. I think it would be very hard to draw the conclusion
that it is. But why do they draw that conclusion and the IOM
study doesn't?
Dr. Goldman. Well, I think it could be they used a
different process for determining causality. But even if PB is
involved, which it could be in some of these illnesses, that
some of the studies that are published for multi-symptom
illness that show high rates among Gulf War veterans, or among
groups of veterans who never deployed anywhere close to the
Khamisyah location where the PB was dispersed. For example,
veterans who were on aircraft carriers the entire time also
have higher rates of illnesses.
Also, we did find in one of the Committees that I served on
a limited and suggestive evidence for association with
organophosphate insecticides that were over there. So there
were many other things that were over there.
As I look at it, it is a very complicated picture. If you
would only focus on the veterans, even if you did conclude
causality, you would only focus on the veterans who were
exposed or potentially exposed to Sarin or to PB, you would
exclude others who may have been affected since the studies
would indicate problems of multiple symptom illness among other
veterans as well.
Mr. Binns. Dr. Roe, if I may respond to your question. And
first I believe that the figure that is generally accepted is
250,000 troops were exposed to PB. That is a figure that I
believe some from DoD estimates. I have seen it from DoD.
Mr. Roe. A third of the troops were?
Mr. Binns. Well that would be about something over a third.
Yeah.
Dr. Steele. About half of ground troops.
Mr. Binns. The other question that you raised earlier
though is an excellent one, and on the science I certainly
defer to people like Dr. Goldman and Dr. Steele and to yourself
as scientists. But Congress recognized that science might never
be able to separate out these issues. Congress understood that
these are difficult questions when you don't have accurate
records and you don't have dose response and so on.
So knowing that, because this law was written well after
the war. This law was written in 1997. They had to make some
decisions as to who got the benefit of the doubt. And that is
where I believe we have an answer already, which is not that we
know absolutely what caused it or didn't, but within the terms
of this statute they wanted animal studies considered. Congress
makes it very clear. Animal studies is put in there about five
times, both for what they wanted in the report conclusions and
for what they wanted the Secretary to consider. And then as I
just described to you, they didn't require that it be
conclusive or causal, they just required that it be equal to or
greater statistical evidence that the veterans exposure could
result in an illness, and they wanted to know undiagnosed
illness exposures as well as diagnosed.
So I think that the statute did resolve it, and I think we
do have an answer as to whether the statute was satisfied.
Mr. Roe. Thank you.
Mr. Mitchell. Mr. Walz.
Mr. Walz. Thank you, Mr. Chairman. I want to continue on
this line, because I think this is an important point that Mr.
Binns brought up. And I think from our perspective there is not
a one of us up here probably in this room that doesn't have a
relative, a friend, a constituent that hasn't suffered from
this. And yes, we know that is anecdotal, yes, we know we want
to apply the best research, but I do believe it was always
the--the spirit of this statute was to get to that point.
Because Dr. Goldman really got to the heart of this in saying
what we are really trying to find out is how do we best care
for them? How do we best develop a line of care? How do we best
treat them? And that is one of the things that I would like to
know.
Is it safe to say or have we come to this conclusion: If
you were a warrior and were deployed during the Gulf War you
have a much greater chance of suffering multi-symptom
illnesses, that is a given, right?
Dr. Goldman. Yes.
Mr. Walz. Okay. So we have established that it is there. We
have best attempts. And granted, I see a little difference in
maybe Dr. Steele. Was it the methodology with the IOM study
that you take most--
Dr. Steele. No. In many ways the methodology of reviewing
the science was very parallel.
Mr. Walz. Okay.
Dr. Steele. It is really about what areas of the science
were considered and pulled together in order to come to our
conclusions.
Mr. Walz. Do you feel like the RAC study maybe got to the
intent of the law was to find what Mr. Binns was talking about
better?
Dr. Steele. We had a different purpose for doing what we
did, but in the end yes, we did consider all of the evidence
that IOM was directed to consider, and we put it together to
talk about associations between illness and exposures.
Mr. Walz. Is anything coming out of this research? And
again, this is for the next panels, but since you have been so
involved in this is, is there any good research coming out for
treatment out of the work that both of these panels have done,
or this more trying to find association maybe?
Dr. Steele. Right now actually the studies have shown that
Gulf War veterans have not recovered over time for the most
part, and we don't have effective treatments for this problem.
But some of the research reviewed in our report talks about
some of the biological findings that we are finding in Gulf War
veterans, and we think this will point us to doing the right
research for treatments.
Mr. Walz. Okay.
Dr. Steele. But right now, no.
Dr. Goldman. My view is that the studies that have been
done to date haven't given us good information about either the
natural history of these multi-symptom illnesses, nor how they
evolve over time, nor the impacts of various types of
treatment, including lifestyle and nutritional interventions
that have been given The nature of these illnesses, just like
many of the illnesses that I suffer from and many of you do as
well, is that lifestyle factors, like smoking, caffeine,
drinking, exercise, make a big difference in health. I think
that this veterans could be benefited by more research. This is
again just my personal opinion.
Mr. Walz. Okay.
Dr. Goldman. Future research could look at the time course
of these illnesses, and also whether these undiagnosed
illnesses turn into diagnosed illnesses. That is even something
we don't know. That happens sometimes. People initially present
with something you can't diagnose and then there is progression
and it turns into something that can be diagnosed.
Mr. Walz. That is an interesting point. Because my final
question on my available time is, while I am deeply concerned
that we get the care, we make this right, as we are equally
concerned with Agent Orange, my fear always in this is have we
learned anything? Did we repeat the same mistakes from Agent
Orange to Gulf War Illness, and are we prepared to repeat the
same mistakes for the returning veterans who are yet
undiagnosed? That is where we should equally focus. And I would
ask each of you if you think, have we missed the lessons
learned here and do we need to start preparing right now?
Dr. Steele. I can just briefly say that we learned some
things but we didn't learn enough. And that is that in the
current deployments in Iraq and Afghanistan we don't see these
multi-symptom illnesses on a widespread basis that aren't
explained by known things. We see other problems. We see head
injuries, we see infectious diseases, things like that.
So we learned enough to one, not give everyone
pyridostigmine bromide and overuse the pesticides. We made
differences in policies that way that helped. But we still have
a long way to go to try to properly assess veterans before they
go, properly keep records of the exposures they encounter while
they are in theater, and then assess them when they get back so
that we can pick up these things at an earlier stage.
Dr. Goldman. Yes I would agree that they are doing a better
job now with pre-deployment examinations and post deployment
examinations and a little more information about exposure. I
would wish that there would be better records kept.
I think one of the biggest lessons though is that
deployment even for a war that seems to be a short war, is a
significant health event. And I think that part of what
happened is that there was an under appreciation of what those
veterans had gone through, and an expectation that they would
be okay. In a sense, that they fell through the cracks.
Mr. Walz. That is a great point. Well thank you all for the
research you are doing, we truly appreciate it.
Mr. Binns. If I could just offer one comment. Whether the
recommendations of our committee's report, which includes
several recommendations for further treatment research, are
adopted or not, is at the moment in limbo because of this
disconnect where VA has stated that it has referred our report
to the Institute of Medicine for review, and yet my
understanding from Institute of Medicine staff is that their
current committee is not in fact reviewing our report.
So if you call could clarify that for me today now that we
have everyone here, that might be a good opportunity to move
things ahead.
Mr. Mitchell. Yes. Go ahead.
Dr. Goldman. I can try. At the same meeting that Mr. Binns
and Dr. Steele presented I also presented to that committee and
that is about all I know of that committee. But my
understanding is that while they are covering the same ground,
this is not a peer review of the RAC report. I think it might
be a matter of semantics. They be producing conclusions in the
same arena, but they are not doing it as a critique of the RAC.
They are doing it as a parallel process, and that is the way
that I understand that they have taken their charge, in a way
is more a positive than a negative. I don't know quite how to
put that. And perhaps we should have a response back from that
committee, just for the record to just completely clarify what
they are doing.
Mr. Mitchell. If the Subcommittee will indulge me. Yes, Ms.
Wedge, you are the chair of the committee that is updating
this?
Ms. Wedge. I am not, I am the study director for that, I am
not a volunteer, I am an IOM employee. But I can clarify this.
We are not reviewing the RAC report. We don't review reviews.
So we are looking at original literature, much of which was
included in the RAC report and anything new that has been
published since the RAC report, and we are updating what was
done in 2006, Volume IV, which was review of the literature. So
we are to look what health outcomes have increased prevalence
in deployed Gulf War troops compared with non-deployed Gulf War
troops.
Mr. Binns. If I can just add to that. The last part is
specifically what that committee is charged to do. It says,
``The committee will summarize the literature on the outcomes
that were noted in the 2006 report; cancer, ALS, neurologic
diseases, birth defects and other adverse pregnancy outcomes,
post deployment psychiatric conditions. The committee will also
review studies on cause specific mortality.''
They are not going to review any of this literature on
substances, the degree to which substances are associated with
illness, that is not their charge. And it is as if someone were
to look at the first, you know, pages 83 through 87 of the RAC
report and say they were reviewing it. Yes, it will bear on
those narrow topics that they are reviewing, but it has nothing
to do with animal studies, with all of these issues we have
been discussing today; nothing.
Mr. Mitchell. Thank you. Mr. Hall.
Mr. Hall. Thank you, Mr. Chairman, and I would like to
submit a statement for the record. Unfortunately I am double
booked. There is a markup in another Committee that I have to
go to shortly.
[The prepared statement of Mr. Hall appears on p. 48.]
First of all thank you and Ranking Member Roe for holding
this hearing, and our witnesses for your testimony, and for
your work.
Dr. Goldman, in your testimony you stated the VA did not
play a role in IOM's examination of Gulf War Illness. Given the
disagreements between your organization and the RAC and the
delayed final product as a result, would you be open to at
least limited involvement of the sponsor or the RAC in the
study process?
Dr. Goldman. Even if I were willing to allow this, my
committee members wouldn't. If you bring a bunch of scientists
together who are tops in their field, which is what these
Committees consist of, they are not really accustomed to taking
direction from government bureaucrats telling them how to do
their work. If they thought that was happening, you wouldn't
get scientists to volunteer to serve on a committee. Scientists
take great pride in working independently; they take great
pride in being skeptical. That is one of the reasons why the
criteria for decisions changed over time.
Mr. Hall. Okay.
Dr. Goldman. It doesn't work that way.
Mr. Hall. You have answered my question.
Mr. Binns, does the RAC see any possibility of expediting a
final IOM product so that we can begin to provide better care
to our Gulf War--or compensation to our veterans in the Gulf
War? And is there anything your group can do to assist them?
Mr. Binns. Again, to go back to what the statute provides.
The law gives the Secretary the option to use other evidence.
He is not required to follow only the IOM reports. He could
look at, for example, VA's own recent large survey of Gulf War
veterans' health, which found that 25 percent of Gulf War
veterans have chronic multi-symptom illness, and that is the
largest problem, and conclude on the basis of that that you
have more than an equal possibility that this is associated
with the war and create a presumption. So he doesn't have to
wait for the IOM.
And I don't think that this process that is going on now
with the IOM committee is going to clarify this whatsoever,
because the IOM committee has a rather narrow charge, and it
will do that charge very well as Dr. Goldman has said, but it
will not clarify whether on these larger issues who is right.
Mr. Hall. Dr. Steele, why do you think that the IOM
considered a narrower scope of evidence than RAC? And what do
we do to rectify this? Or in the future perhaps should we do to
rectify this?
Dr. Steele. You know, a lot of people believe there are
different motivations from different sectors that are driving
this. I actually have no idea about any of that.
All I can say is that Gulf War Illness is very complicated
as Dr. Roe indicated. And the evidence that has now accumulated
over 18 years is very complicated. And it is really--it doesn't
work to just sort of cook book a little method where you look
at all these studies of cancer and all these diseases that Gulf
War veterans don't have and see if the human evidence indicates
that Gulf War exposures leads to these diseases.
In other words, it was just the very limited scope of what
they looked at in very great detail, but that this didn't
really address the elephant in the room.
So they chose to do the method that they use for Agent
Orange. That may have been appropriate for that, but it really
was not appropriate for this more complex situation.
Mr. Hall. Is this the biggest population that you are aware
of that is been given PB pills?
Dr. Steele. By far. By far. Nothing even close.
Mr. Hall. Is PB currently being prescribed for anything or
given to humans?
Dr. Steele. It is. As we talked about it is prescribed for
a specific disease, myasthenia gravis, it compensates for a
chemical deficiency in myasthenia gravis. In healthy people, in
soldiers it is still approved for use in the war theater for
one specific nerve agent, but it has not been used for that
purpose since the Gulf War.
Mr. Hall. To your knowledge do people who are receiving PB
to restore their nerve transmitter normalcy, are they
exhibiting any of the same symptoms?
Dr. Steele. On a short-term basis, yes. If they go off the
PB they are terribly ill. I am not sure you would notice Gulf
War syndrome kinds of problems long term in people who took PB
for 2 weeks and then went off of it. So it is not apples and
apples, it is apples and oranges.
Dr. Goldman. In the way that is the crux of the challenge
that all of these committees have had when they look at these
substances. Because you can look at what PB does to people who
are chronically on PB because they have myasthenia gravis,
which is a chronic disease. You don't have a bunch of people
who were on PB and then off of it, and then a couple of years
later develop or didn't develop a chronic disease.
Dr. Steele. You have one group like that.
Dr. Goldman. So, you can find a few studies like that, but
it is difficult to find a lot of evidence like that for almost
anything.
Dr. Steele. Except if you look at Gulf War veterans who are
the study group.
Dr. Goldman. Right. So you have the veterans themselves for
whom we know that around 25,000 people were given the pills.
But then in the studies not everybody given the pill takes the
pill. It is very complicated. Some take one or two pills, some
take the whole pack, some don't take any pills at all. So when
you start taking the studies apart, if that is all you have and
then you get back to the problem with the exposure information
I agree with you.
Dr. Steele. Absolutely, it is very complicated. But you are
right, if that is all you had you probably wouldn't think that
it was causally associated. But since we have so much more that
all point in the same direction we feel that high hurdle of
causality was met.
Mr. Hall. Dr. Steele, and Dr. Goldman also, did your
studies show depleted uranium (DU) as a factor at all?
Dr. Steele. No. Depleted uranium, along with several other
exposures during the Gulf--there was very little evidence to
support any connection between depleted uranium and Gulf War
multi-symptom illness. We don't know if it may be associated
with other things. There haven't been a lot of studies in
populations that have looked over the long term after an
initial exposure.
Mr. Hall. Well it hasn't been long enough for some of the
diseases you would be looking for.
Dr. Steele. In theory, if there were to be cancers for
example resulting from this, some would have been showing up by
now, but no one has been looking at that.
Mr. Hall. Thank you.
Dr. Goldman. And this means it depends on the type of
cancers; different types have various latency periods. There
are ongoing studies of the depleted uranium, and I think that
those are important, because this is also probably the first
time there has been a large enough group of people with
documented DU exposures to be able to carry out those studies.
Some cancers kept very long latency periods, some shorter, and
I think it is worthwhile to look for that.
Mr. Hall. To keep an eye on it.
Dr. Goldman. Yes.
Mr. Hall. Okay. Thank you very much. Thank you, Mr.
Chairman.
Mr. Mitchell. Thank you. And I want to thank this panel for
the work that you are doing. It is very valuable, and I think
as we get into the rest of the testimony with the rest of the
panels we will find that there is not much more we can debate
about what your two charges are; it is now going to be up to
the VA to make a decision.
So I want to thank all of you for the research and the
dedication you have put in to helping our veterans. Thank you.
Dr. Goldman. Thank you very much.
Dr. Steele. Thank you.
Mr. Binns. Thank you
Mr. Mitchell. I would like to welcome panel number 2 to the
witness table. For our second panel we will hear from Dr.
Robert Haley, Professor of Internal Medicine at the University
of Texas Southwestern Medical Center; Dr. Roberta White,
Professor and Chair of the Department of Environmental Health
and Associate Dean of Research at the Boston University School
of Public Health; and Anthony Hardie, a Gulf War veteran from
Madison, Wisconsin.
Again, if you would please keep your comments to 5 minutes,
and after that I want you to also know that your complete
statement will be in the record. I would like to recognize
first Dr. Haley, then Dr. White, and then Mr. Hardie up to 5
minutes.
STATEMENTS OF ROBERT W. HALEY, M.D., FACE, FACP, PROFESSOR OF
INTERNAL MEDICINE--EPIDEMIOLOGY, DEPARTMENT OF INTERNAL
MEDICINE, UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER AT
DALLAS, TX; ROBERTA F. WHITE, PH.D., PROFESSOR AND CHAIR,
DEPARTMENT OF ENVIRONMENTAL HEALTH, AND ASSOCIATE DEAN FOR
RESEARCH, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH, BOSTON,
MA; AND ANTHONY HARDIE, MADISON, WI, (GULF WAR VETERAN MEMBER,
RESEARCH ADVISORY COMMITTEE ON GULF WAR VETERANS' ILLNESSES)
STATEMENT OF ROBERT W. HALEY, M.D., FACE, FACP
Dr. Haley. Mr. Chairman, Ranking Member Dr. Roe, other
Members of the Committee, I am a professor of internal
medicine, epidemiology, and clinical science at University of
Texas Southwestern Medical Center. I spent 10 years at the
Centers for Disease Control and Prevention doing research,
epidemiology research, and I have been on the faculty for 25
years at Southwestern doing clinical research.
The purpose of this morning is to describe our research
program. We have been working on this for 15 years, and we now
have a large group of researchers from eight different
universities around the country collaborating. And our goal is
really to move beyond what caused this and try to find out what
do we do about it.
So we really have three goals for our research program.
One, to understand the medical reasons for this multi-symptom
illness. What is causing those symptoms?
Second, to develop an objective diagnostic test. Because
what we need in the VA is for every VA Medical Center to be
able to perform some objective tests to say who has this
illness and who doesn't, both for service-connected purposes,
as well as for our diagnosis and triaging people to the
appropriate treatments.
And third, to actually develop the scientific basis for
developing new treatments, because we are pretty optimistic
that there perhaps will be treatments for this that will make
these people feel better.
The program really has three major components, and I will
just sort of discuss those from the big picture all the way
down to the brain cell research.
The three components are first a national survey in a
random sample of 8,000 Gulf War veterans selected randomly from
the entire population. The purpose of that is to take a look at
the illness, manifestations, 19 years, 18 years after the war.
We have a component in this looking at the longitudinal
effects. Has this improved, got better, gotten worse, or what?
We are also collecting blood samples from all of the sick
veterans and a random sub-sample of the well veterans, about
2,000 in all, to get DNA and do a, we hope eventually, a
genome-wide association study to see if we can look at the
genetic basis of this illness. So that is the national survey.
The second part is a series of brain imaging studies,
sequentially repeating a set of brain imaging studies in one
group after another to try to hone in on what are the right
tests to do to understand these symptoms; what is causing those
symptoms. And then to use that to develop a diagnostic test and
also to bear on treatments.
To date we have studied one major group of veterans, and we
are getting ready to now study a sample from our National
survey, so that the results of that--we are going to try to
replicate what we found in our first series of studies in a
group that is nationally representative so that it would be
even stronger evidence. So that is the neuroimaging phase.
And the third phase is a basis science studies looking at
what do those chemicals, pesticides, pyridostigmine bromide,
PB, and Sarin nerve agent, what do these do to brain cells?
Because if we can figure out what these chemicals--assuming
that these were the cause, and we don't know that for sure--but
if they are, what do they do to brain cells, and if we know
that, we may be able to reverse engineer this and come up with
an antidote that actually reverses the symptoms. On the model
of Parkinson's disease, when they figured out that dopamine
problems were causing Parkinson's, we came up with El dopa and
other medications.
Now our findings to date, in our National survey, we have
reconfirmed again that there is a unique Gulf War syndrome. It
has three variants, which are important to know because they
had different brain imaging findings, and we think they
actually are different components of illness. We have also
looked at the time course and shown that Gulf War veterans are
not getting better.
Now in the brain imaging studies we have looked at each of
the symptoms of Gulf War Illness. Memory problems, thought
process is slowed, constant body pain, chronic fatigue. These
are the major symptoms that cripple these veterans. And our
brain imaging studies can show what the brain is doing when
they are having these symptoms. We can illicit these in the
brain scanner and show exactly what is happening to the brain.
And we now are coming up with what the mechanisms are of this
multi-symptom illness in the brain. And so we think from this
we will develop diagnostic tests that we would be able to then
hand off at the VA Medical Centers around the country to
diagnose Gulf War Illness just the way you would diagnose
thyroid disease or whatever.
And finally our studies in animals. We developed a mouse
model in which we can give low doses of pesticides, PB, and
Sarin nerve agent in collaboration with the U.S. Army at
Aberdeen Proving Ground, and we can reproductively now produce
a behavioral disturbance in mice, which interestingly, just
like in Gulf War veterans, doesn't come on immediately; it
takes about 6 weeks or so for this behavioral disturbance to
occur, which would be just what we saw in the Gulf War with
Gulf War veterans. And we now have ten different laboratories
around our university and in some other places looking at mouse
models to see what is happening 3 months later after this
exposure. What has changed in the brain in the ones exposed to
the chemicals compared to the ones that were not exposed? And
the idea is, if we can get down to the molecular mechanism of
what is changed, we may then be able to reverse engineer that
to a medication or some other rehabilitation treatment that
would actually reduce the symptoms or eliminate the symptoms of
this illness and return veterans back to a normal life.
Now, I must say, having talked with hundreds of Gulf War
veterans who are my patients through the last 15 years, I have
not found one veteran that wants to be service-connected and
get disability. They all say, doctor, I want somebody to make
me well so I can go back to work. I would like to go back in
the military is what they say.
And so our goal is to use brain imaging, understand the
brain mechanisms of these symptoms, develop a diagnostic test
from that, correlate that with the animal models and see if we
can then develop a treatment for it.
[The prepared statement of Dr. Haley appears on p. 62.]
Mr. Mitchell. Thank you. Dr. White.
STATEMENT OF ROBERTA F. WHITE, PH.D.
Dr. White. Good morning, Mr. Mitchell, Dr. Roe, and Members
of the Committee.
This morning I want to talk about my experience with Gulf
War veterans over the last 16 years and their health problems.
I will speak from a research perspective on the epidemiologic
investigations in which I have participated. These studies have
examined health outcomes related to chemical exposures in Gulf
War veterans. I will also talk about my clinical experience in
working with veterans as a neuropsychologist at the VA and in
university medical center settings. My aim is to integrate
these two sources of experience in order to better provide an
understanding of the challenges involved in understanding and
treating Gulf War Illness.
As mentioned in my prior testimony in May, our research
efforts in Boston over the last 16 years have focused on
relationships between exposures experienced in the Gulf War and
health outcomes. We have carefully controlled for stress
symptoms, diagnosis of post-traumatic stress disorder (PTSD),
psychiatric diagnoses, and other variables that affect
performance on our outcomes like neuropsychological test
performance, questionnaire answers, and neuroimaging results.
These are the confounders that Dr. Goldman talked about.
These studies have led to the five conclusions that I am
going to summarize this morning. First, pesticide exposures in
Gulf War veterans are associated with increased health
symptoms, especially those involving the central nervous
system.
In addition, such exposures are associated with poorer
neuropsychological test outcomes and with chronic multi-symptom
illness.
Second, exposure to pyridostigmine bromide is also
associated with neuropsychological test outcomes and increased
health symptoms.
Third, mixed exposure to high levels of pesticides and PB
is associated with more severe effects, including elevated
health symptom complaints, poorer neuropsychological test
outcomes, and chronic multi-symptom illness.
Fourth, exposure to nerve gas agents in Khamisyah is
associated with poorer neuropsychological test performance and
smaller white matter volumes in the brain in a dose-dependent
manner. That is, higher exposure predicts greater pathology.
Fifth, Gulf War veterans with higher numbers of symptom
complaints have smaller white matter volumes on brain imaging
than those with low numbers of symptoms.
It is important to note that the above findings were seen
in veterans who were not diagnosed with clinical illness by
physicians. They did not have diagnosed brain damage nor were
their neuropsychological or brain imaging results considered to
be in the abnormal range. Most of the study participants were
working at the time of their participation.
The epidemiological study results suggest that there are
subtle changes in brain structure and function associated with
chemical exposure in Gulf War veterans. Such changes are often
referred to as ``sub-clinical'' central nervous system effects
of exposure. The research results suggest that these exposures
are also associated with significant experiences of poor health
and dysfunction in daily life.
How do such findings relate to the clinical examination of
individuals with exposure to pesticides and other neurotoxic
chemicals? When patients are seen clinically,
neuropsychological test results and brain imaging can vary.
They can be abnormal, but they can also be interpreted as being
normal, even among patients who experience significant health
symptoms and functional problems in daily life. This reflects
the insensitivity of the diagnostic tests available as well as
other factors.
Gulf War veterans often show this picture, and it can be
perplexing to clinicians when they observe poor health and
multi-symptom complaints in individual patients. This may lead
to confusion about diagnosis, treatment options available for
patients, and even whether to accept the patient's complaints
at face value.
The clinical and research evidence suggest that health
symptom complaints in Gulf War veterans should be taken
seriously, especially if the veteran has known exposure to
neurotoxicants in theater. These include pesticides, PB and
Sarin and Cyclosarin gas exposure. Diagnosis of post-traumatic
stress disorder is made and compensated based on self-report of
psychological symptoms in the context of a significant
stressor. Self-reported physical symptoms and dysfunction in
daily life deserve to be taken just as seriously.
[The prepared statement of Dr. White appears on p. 68.]
Mr. Mitchell. Thank you. Mr. Hardie.
STATEMENT OF ANTHONY HARDIE
Mr. Hardie. Thank you Chairman Mitchell and Ranking Member
Dr. Roe and Members of the Subcommittee. I would also like to
thank my fellow Gulf War veteran, Matt Letterman, who drove
here on his tractor across the country to be here and it is
really an honor to have other Gulf War veterans here as well.
Thank you for the invitation to testify today regarding
implications of U.S. Department of Veterans Affairs' Limited
Scope of Gulf War Illness Research. By limited I take that to
mean it hasn't been focused on treatments to help improve our
lives.
I am honored to fulfill the Subcommittee's request to
testify today as a Gulf War veteran regarding my own personal
experiences, observations, and recommendations on these issues,
most of which is contained in my written submission due to the
time constraints. My experiences are far from unique, and I am
sharing them in the hope that it will help to better inform the
Subcommittee and the VA and to help assist countless thousands
of my fellow Gulf War veterans who like me have been injured
and ill for nearly two decades following the war without
effective treatment.
In mid January 1991, my team was directed to begin taking
the PB pills that we had all been issued. We were told they
were experimental, not FDA approved, that we had no choice in
consenting, we were ordered to take them, and that we would
probably experience symptoms similar to mild nerve agent
poisoning; which was the case.
Like tens of thousands of my fellow Gulf War veterans, I
experienced significant side effects including watery eyes,
runny nose, confusion, dizziness, muscle twitching, diarrhea,
weight loss, and a host of other symptoms, including feeling
generally ill.
Because of the technological advances of the 1991 Gulf War
displayed around the clock on CNN, it was easy to understand
why there was and seems to be a persistent belief in the U.S.
that for the first time in history, there was no fog of war
during this war. On the ground it was most definitely a
different story as in every war before.
We were told that the Iraqis has not used or even forward-
deployed their chemical weapons and the alarms must have been
sand or other false alarms. We now know today that wasn't true.
We received communication at one point that a nearby unit
at R'as al-Mishab had been hit with chemicals, a chemical
warfare agent, and we later received communication that the
chemicals had been confirmed. If I remember correctly by the
British. Later, it was discounted as simply a false alarm,
despite the second confirmation. This story is far from unique,
with Gulf War veterans having echoed similar stories in
previous public testimony.
When we launched into southeastern Kuwait with coalition
forces, we found a sand-table map covered with chemical warfare
and other symbols. That was the object of great interest to the
Untied States Central Command officers who flew in the
following day before the facility was closed off permanently
thereafter.
In one bunker complex north of the Kuwait Bay, a handful of
us went through, I was captivated by the lovely fragrance that
smelled just like the red flowers that filled my grandmother's
garden back home, and it pervaded all of those Iraqi bunkers
that I went through that were so hastily evacuated that plates
of half-eaten food and loads of personal gear had been left
everywhere. In fact, for anyone who has ever been in the
military to leave half-eaten food is the most unusual thing you
could ever imagine. No one is going to leave food behind.
Years later I was horrified to learn that what I smelled,
along with the pervasive smell of wet onions, was the
characteristic odors of Lewisite and Mustard, a classic mixture
used heavily by the Iraqis during the Iran-Iraq war. Even
still, I discounted my own severe respiratory illness as having
been from that, simply because I didn't know until just a
couple of years ago that while the damage is immediate,
symptoms don't necessarily evolve until as long as even 24 to
48 hours after exposure.
I have now heard enough first-hand accounts from Gulf War
ground troops about coming across chemical mines and all sorts
of other chemicals that I now firmly believe that the Central
Intelligence Agency and the DoD had and have no basis for their
long-held statements that Iraqi ground commanders never
possessed or used chemical weapons during the war. The extent
and impact of intelligence failures were widely discussed on
and off the battlefield as part of that fog of war.
Sadly for most of my fellow Gulf War veterans who are ill,
the VA's limited scope of Gulf War Illness research on
treatments has not even begun to yet address the health
outcomes associated with these widespread chemical warfare
agent exposures, exposures to pyridostigmine bromide, and all
the other agents that were--and exposures that were listed in
the Persian Gulf War Veterans Act of 1998 by Congress more than
a decade ago. We know what caused Gulf War Illness, we just
simply need to work on treatments.
I have had difficulties and experiences with my VA,
including most recently I had--my cough for example has never
subsided since 1991. This spring after 18 years, I was finally
able to get a brochoscopy looking into my lungs, and its
results were yet one more bittersweet revelation, like the
revelation from the Research Advisory Committee in Gulf War
Veterans' Illnesses that finally acknowledged that Gulf War
Illness is real and that what has been going on with this is
real. The revelation was my lungs were red, irritated, and
angry looking with mucus and a diagnosis of a form of chronic
obstructive pulmonary disease. For me this was no surprise.
Due to VA's limited scope of Gulf War Illness research not
focused on treatments or effective diagnosis, I found this
bittersweet victory on my own with private health care, not at
a VA facility.
As I have often said, if it weren't for the military I
wouldn't have been able to keep on struggling to stay in the
workforce, but then again if it weren't for the military well,
I guess I wouldn't have had to.
Submitted with my written testimony is a statement written
by my mother more than a decade ago in support of my VA claim,
which has been challenging like most other Gulf War veterans.
It could frankly have been written by any Gulf War veteran's
mother describing what she saw in her son, all the symptoms,
all the changes for the worse.
Clinicians at local VA hospitals, still after 18 years,
seem to have no idea what to make of or to do for Gulf War
veterans than simply to put band-aids on our symptoms. Because
of VA's research inadequacy it is not focused on treatments for
Gulf War veterans, clinicians at VA facilities have not known
what to tell Gulf War veterans, what to do that might even help
to improve our health or lives, and as well have not been known
for what to tell us to avoid or be careful of.
VA and other doctors have not known to tell ill Gulf War
veterans to avoid at all cost any additional exposure to
pesticides, paint primers, and related chemicals. I have had to
find that out on my own, like so many other Gulf War veterans.
A friend like Joel, a career soldier and now lives in Iowa,
I believe he is truly a hero. He is now totally disabled,
despite being a decorated multi-combat tour veteran. This is
not right.
And finally, like many Gulf War veterans, I have beliefs in
how we got to this point when more than 18 years later we have
almost nothing to show for all of it, with the exception of the
most recently funded promising ongoing DoD Congressional
Directed Medical Research Program research and the University
of Texas Southwestern efforts. There are no treatments, no
advisements, no adequate assistance to give ill Gulf War
veterans, and the benefits process is grossly broken.
Later in this hearing you will hear from others more
eloquent than me about how VA's fundamentally flawed contracts
with--or earlier reliance on reports have led to today's stark
failure regarding Gulf War veterans' illnesses. The greatest
failure is one of the outcomes. More than 18 years after the
war, VA has essentially nothing to show for or to provide to
Gulf War veterans for all of its quote ``efforts,'' and little
or nothing to offer the one-fourth to one-third of all Gulf War
veterans who like me remain ill, disabled, at home, and with no
effective treatments.
I am happy to answer any questions, and again thank you for
this opportunity.
[The prepared statement of Mr. Hardie appears on p. 70.]
Mr. Mitchell. Thank you very much. Dr. Haley, a couple
things. What are your thoughts regarding the differences
presented here today between the RAC and the IOM in their
findings?
Dr. Haley. Yeah, that is a bit far a field from what we are
doing. Basically I think it comes down to how you ask the
question, and if you ask the question differently you get
different answers. I think that is basically my take on it.
Mr. Mitchell. One other question. With all the missing
links of DoD documentation of what veterans were exposed to, do
you believe that science will ever be able to answer why Gulf
War veterans continue to suffer these undiagnosed symptoms? Is
there any hope for veterans through science?
Dr. Haley. Yes, I think so, and that is where we are
focused. And you know, the question is, what help are you
talking about? If we are talking about proving what caused this
we will--with further and further epidemiologic and clinical
research, we can get closer and closer to that. We will never
be able to say that perfectly, but that is not what the
veterans are looking for. The veterans want to know how do I
get better? And what they need is a diagnostic test, an
objective test that they can go to their VA and the doctor can
say, oh you have Gulf War Illness, well let us send you over
here to go through the test battery. And the results come back
from the doctor and he says, oh you have type one Gulf War
Illness or type two Gulf War Illness. Well, we know here is the
treatment for that, and we will then send you over to the
clinic and give you the medication or the rehab strategy or
whatever. That is what they want. And there has been very
little research done in that way, and that is our total focus
is to do what a group of scientists--and we have done this, sit
down and agree with scientists--how would you get to a
diagnostic test and how would you get to a treatment? And the
idea is the plan that we have here. And we are fairly far
along.
In our second study that we just finished we now believe we
can see what is going wrong in the brain when they are having
problems with memory, or when their thought process is slow,
when they are having constant body pain.
We can see parts of the brain that are now functioning. And
we are getting ready to try to replicate this now in a random
sample of the population to be absolutely certain of this. And
then we think from this we will be able to develop--within the
next year or so--we will have a diagnostic test that we can
hand off to VA Medical Centers so that Anthony and other
veterans like him can go to a VA and get a real diagnosis with
objective tests that has a high degree of certainty to it. And
then another couple of years, 2 or 3 years down the line, we
hope our studies in animals will then lead to clues about what
kind of drug or what kind of rehab strategy we will need to
cure that. I think that is really what the veterans are looking
for.
Mr. Mitchell. Thank you. Dr. White, based on both your
clinical experiences with Gulf War veterans and your scientific
research, do you believe the IOM's report draws significant
conclusions and findings?
Dr. White. Well, I am not exactly sure how to answer that
question. We heard today that they believe that Gulf War
Illness exists, which is something that is a little difficult
to find out of the report. I believe that the scientists at
IOM, and I do work for IOM myself as a volunteer, I am on a
committee right now, work in good faith and try to do what they
are supposed to do.
I think they looked at different data, looked at it in
different ways than the RAC did, and that really what needs to
be done is that all the sources of evidence and summary reports
that have been produced need to be considered by VA.
Mr. Mitchell. Thank you. And Mr. Hardie, as a well-informed
Gulf War veteran who is a member of the RAC, are your
perceptions of the VA's interest in Gulf War research in caring
for the--or what are your perceptions of the VA's interest in
Gulf War research and caring for our ill Gulf War veterans?
Mr. Hardie. Well first I would like to say that I think
that their intentions are honorable. I think that they have a
very difficult job. I think that the difficult job, they are
sorting through the directions given to them by law from
Congress, they are sorting through all the scientific
recommendations, the recommendations being given to them by
veterans, and many of them are not medical doctors as well so
it makes it even more challenging.
At the end of the day I guess I am not so interested in
where we were or how we got to where we are today, I am deeply
frustrated. It is heart breaking when I find my veteran friends
on Facebook and so many are ill, so many are totally disabled.
This affects women veterans as well.
I think the focus has got to be on--Dr. Haley clearly has
been working with Gulf War vets like me. He said it again
today, and that is that we need to be focused on helping Gulf
War veterans to get better, and that is really what this has
got to all be about.
Mr. Mitchell. One last question as my time is up. If you
could sit down with Secretary Shinseki as a Gulf War veteran,
what recommendations for the way ahead would you give to him?
Mr. Hardie. I would say that programs like the Prosthetic
Research Program have been profoundly effective, and model
programs after the prosthetic--VA has done wonderful work on
prosthetic research making a huge impact for those who have
lost their limbs. I would say to follow the National Center for
PTSD with their ways of informing people and clinicians with
clinician guides. And I would say to follow other effective
models that have worked. Traumatic brain injuries (TBI)--I have
been evaluated now and gone through that program and have
talked with folks there. Have folks go through the TBI Program.
Give people memory aids. Give them like we do for TBI troops
coming back from Iraq and Afghanistan, give them a Palm Pilot
if that is going to help them to remember their appointments
and so on.
But all the things that are working now, focus on those
kind of things and focus on doing the kind of tests like lung
tests for those of us who have lung injuries, whether they be
biopsies or whatever might be the case, I think they will find
there are things that can be treated as well.
Mr. Mitchell. Thank you, my time is up. Dr. Roe.
Mr. Roe. Thanks, Mr. Chairman. And just to give you an idea
about how absolutely complicated this is, and I think one of
the reasons when the war was first over and the veterans came
home, I think one of the things that had delayed this were the
very low number of casualties. I think that threw everybody off
a little bit. There were no casualties, so for a long time no
one looked for anything because we--I mean for one it is too
many, but for the number and the number of troops that were
sent--I was raised in Clarksville, Tennessee where the 101st
Airborne is, and I think they came back without a single
fatality from that war, which is astonishing when you think
about it. But I think where we dropped the ball was we didn't
think there could have been some other casualties.
The other thing that made this difficult, just to give you
an example, 17 percent of the population have headaches. If you
look at depression, that is where I think we got thrown off, a
certain percentage of it. So when you combine, especially Dr.
Haley in your phase one, I read your study last night, and I
think that is what threw people off to begin with was because
here you had something that has a prevalence and an incidence
in the population in general, and was there a cause and effect.
And I think that is where we got thrown off.
I think Mr. Hardie that is what happened. And not to
apologize for anybody, but I can see how it happened. And I
think now you are absolutely right, that is all behind us, let
us do something to fix it.
The question I have, Dr. Haley, for you is have these
studies of the brain been reproducible, and when you compare
them to someone who is let us say depressed or has chronic
headaches, do you see similarities in the findings? Just for
clinical.
Dr. Haley. Yeah, that is the key question. And we actually
did these studies--a subset of these studies we are doing now
we did 10 years ago on the same group that we just brought back
to do 10 years later, and we find that the ones that showed
abnormalities 10 years ago are right on target again. That is,
for example, there is a chemical test, an MR spectroscopy, NMR
of the brain, and you can study chemical changes. Ten years ago
we reported a finding where basal ganglia, these deep brain
structures down in the middle of the brain and the brain stem
had a chemical imbalance, actually a reduction in a chemical.
It was a definable chemical difference that has been shown in
many studies to indicate damage to neurons. And then 10 years
later, we brought these same guys back and they have the very
same thing, the same side of the brain, the right side of the
basal ganglia is worse than the left just the way it was 10
years ago.
Similarly, we have done a spec study where we give them a
medication that simulates a Sarin exposure or a pesticide
exposure. It is a benign medicine that doesn't hurt you, but it
stimulates the same parts of the brain. Ten years ago we showed
that sick Gulf War veterans respond just the opposite to
normals to this drug. That is, something through those parts of
the brain so that the response is exactly 180 degrees from
normal, and we just replicated that and found the very same
thing is occurring 10 years later, and now we are getting ready
to do this in a totally new group. It is a random sample of the
population to see if it replicates out in the total sample of
Gulf War veterans.
Mr. Roe. How many have been studies? I know there have
been--I think PB--Mr. Hardie, I may have heard this wrong, a
quarter of a million troops, and is that accurate from the RAC
study?
Mr. Hardie. It was stated on the earlier panel, but I
believe it was--250,000 was the number I heard.
Dr. Haley. In our current study we have 60 veterans, about
15 in each group. We have three syndromes, syndrome one, two,
and three, they are clinically different, and then a control
group. In a neuroimaging study typically you have between 10
and 20 per group, and we have 10 to 15 in each group. What we
are going to be doing when we bring in the national sample, we
are going to have 20 per group to give us even more power than
we need.
Mr. Roe. And Dr. White, just out of curiosity, I was raised
on a farm and fooling around with a lot of pesticides. Do you
have anything in the farm community where--I mean, I have seen
crop dusters fly out and as a kid that was a great thing to go
watch, I mean you got dusted.
Dr. White. Well the pesticides of greatest importance that
were used in the Gulf War in terms of the health effects are
organophosphates and carbamates, both of which are neurotoxic.
There is a huge occupational literature on farmers, migrant
workers, lots of different occupational groups, and you see the
same kinds of patterns in those groups where they have
symptoms, sometimes even depressive or behavioral changes after
long-term exposure. So what we are seeing in the Gulf War
veterans in terms of pesticide effects is very consistent with
what you see in farmers.
Mr. Roe. Just in conclusion. Mr. Hardie thanks for your
service to your country, and we will try to get this right.
Mr. Hardie. Thank you, sir.
Mr. Mitchell. Thank you. Mr. Walz.
Mr. Walz. Thank you, Mr. Chairman. I would echo the Ranking
Member's sentiment, thank you so much for your service and also
for you to know Mr. Hardie that we appreciate your continuous
service to your comrades in arms to get this right and to know
that our responsibility is to make sure it is not just thanks,
but in a tangible way this Nation thanks you and that is by
making sure our care is right. So I am really pleased that both
these panels have been focusing on how we take this to the next
level of providing care.
I do think it is important to note in this that our
majority counsel is a Gulf War veteran, was at Khamisyah, and
those things matter. Because the Chairman and the Ranking
Member are very, very cognizant of this issue.
And I would also note, I saw Mr. Hardie you are from
Wisconsin, so I know both of us are glad Bret Farve is retired.
I am from Minnesota so get that straight.
There was a statement in here in your statement Mr. Hardie
that I think really sums up where we are at, and I have to be
honest with you, it is very touching, but also incredibly
frustrating for me. Here is what it says, ``Thousands of other
young men in their twenties and thirties suffer in silence not
wanting to complain. Someone needs to speak out for them. If
the Government waits until all the studies are done before they
act, it will be years and then it will be too late.'' That was
written by your mother on March 27th, 1998.
Mr. Hardie. Yes, that is right.
Mr. Walz. And here we sat listening to some studies,
listening to where it is at. I will have to say though, Dr.
Haley, your comments about us getting much closer to the idea
and then listening to what we just heard in the last panel, we
can get to the point, we can get a diagnostic test, we have met
the threshold of benefit of the doubt for the veterans, we can
get that done and we can move forward.
And Mr. Hardie, I would ask you, I am with you on this, I
am the biggest advocate of the VA. These are people that want
to do right. But because of that I am also their biggest
critic.
What would happen today for someone who was a Gulf War
veteran, they walked into a VA hospital and said, I got body
aches, just can't rid of this, what would happen to them?
Mr. Hardie. Well, I think that it varies depending on the
location. I think that at this point my experiences are
different than some others.
I have heard as recently as this spring that a Gulf War
veteran walked into a VA Medical Center in--I will get the
State wrong, I thought it was Oklahoma--but was told that there
was nothing wrong with him and he was complaining and seeking
help from others that he was just simply getting sent to mental
health.
In my case being sent to mental health was the best thing
that ever happened to me because they referred me back to
primary care and to specialty care because they said that it
wasn't associated with any known psychological condition. So I
would hope that that is what would ultimately happen with that
veteran as well.
At this point, I think that the VA doctors are very
compassionate, they are very talented, they are caring, they
are a wonderful bunch by and large. I couldn't say that 15
years ago with a couple of bad experiences, but I would say
that today unequivocally. And I think that they will do their
best to try and treat symptoms. But again, I think the
problems--I have always believed this--the problems lie here in
Washington and the problems lie here because the VA docs will
do the best they can to treat symptoms, but they don't know
what to do for folks. If you have a chronic cough, how often do
you see Mustard Lewisite veterans anyplace? How often do you
see folks who have Sarin brain damage anyplace? And so we need
to find answers to what to do to make people's lives better.
And the benefit system is broken, just to add that in
there. That is a whole separate topic, you could have countless
hearings on that. The benefits system for Gulf War veterans is
not okay. The benefit system is terribly broken for service-
connection, which is the gateway to getting health care.
Mr. Walz. Well, I agree with you as I said, and just like
your mother said, okay, we have studies, that was 11 years ago
now.
I think Dr. White said it, I think it was pretty
unequivocal today, and I haven't heard it a lot, that yes, it
is an absolute connection, that we agree that there is a
connection there. We don't know the actual causality and all of
this, but if you are deployed to the Gulf War, you are going to
come back with something wrong with you, you know, in more
cases than not. Is that true, Dr. White, is that kind of what
you heard?
Dr. White. Well, I mean I have heard that, that a
substantial portion of people who come back from the Gulf War
have this. Probably 25 to 33 percent.
I will say that the VA knew Gulf War veterans were coming
back with symptoms very early, because they started calling me
about it within a year of the war, they were paying attention
to it at that time.
I would also like to say that I think we really need to pay
attention in terms of diagnosis, compensation, and triaging
people for treatment of symptom complaints. I don't think there
has to be a physical diagnostic test. And that if we wait for a
physical diagnostic test we are going to hold up paying
attention to empirical and mechanism-based treatments that we
can be starting right now.
So really when I said we need to believe what Gulf War
veterans say about their symptoms, we know what the core set of
symptoms is, I meant that. We do that for PTSD, and we should
do it for Gulf War Illness.
Mr. Walz. Well, I think the time has come. My biggest fear
is, and I can tell you that the Gulf War veterans and there are
some here and obviously you, Mr. Hardie would say, take down
their words and we will come back in 11 years from now on this
hearing and still be following it. And they would say that not
out of cynicism, but out of experience. I hope our pledge is
that that is not the case, that we break this. I think we are
at a breakthrough point and maybe we will get there. So I yield
back.
Mr. Mitchell. Thank you. Mr. Alder.
Mr. Adler. Thank you, Mr. Chairman.
First, Mr. Hardie, thank you for a couple things. I join my
colleagues here in thanking you for your great service to our
country. I also thank you however for your conversation with
Mr. Walz regarding the quality of physicians and other medical
providers you have encountered at the VA.
We have had a couple experiences in the last few months on
this Subcommittee. We have had to look at some situations where
VA hadn't quite met the standard we would seek for all of our
veterans everywhere across the country, and so I think it is
very gratifying for all of us in the Subcommittee to hear a
positive testimony on behalf of the men and women that work in
the VA system and try to do the best they can.
But as I heard Dr. White's comments just now about 25 to 30
percent of our Gulf War veterans presenting with symptoms and
multi-symptoms, if you can't somehow put it into a box and say
what the disease is, it is still a disease. These people need
help.
I guess I am wondering from your panel what any of you
could recommend we could do to expedite either a correct
diagnosis through better research, or a better education of our
VA physicians and other providers so we don't have Mr. Walz'
nightmare scenario of 11 years from now reading back Mr.
Hardie's mom's words in frustration again. Maybe one of you
could give us some suggestions of what we can do to move the
ball forward quickly and effectively for our vets.
Mr. Hardie. I am going to defer to my scientist colleagues,
but I would just like to say just briefly, that you know, if
Dr. Roe were treating a patient and the patient presented with
a condition that he had never seen or heard of before and it
was called amyotrophic lateral sclerosis (ALS), it would be
very difficult to figure out what to do with that patient. And
I know we still don't have treatments for all the Gulf War vets
that have ALS and multiple sclerosis (MS), the same kind of a
situation. A condition like acquired immune deficiency syndrome
presents lots of conditions in lots of different ways. I think
there are underlying mechanisms and I will defer to my
scientist friends here to perhaps elucidate that better.
Dr. Haley. Yeah. You know, if you look back in the history
of developing treatments for diseases there are really
basically two ways that you do it. One is you just happen upon
a treatment by trying to treat people, you know, digitalis and
some of the famous drugs, nobody ever did studies of those,
they just happened upon it.
And the other way is to do very detailed research,
understand the mechanisms of the disease, and engineer a
treatment, that is called the rational approach as opposed to
the serendipitous approach. We ought to be doing both.
And I think Bobbie said it right. I think it would be good
for the VA right now to declare a real effort to educate the
physicians. You know there was an education program like what
15 years ago that said basically this is psychological and you
don't really need to do anything about it, and that has never
been changed as far as I know, that is the record. And so it
would be very productive to rethink that and say when people
come in with symptoms here are a bunch of things we can try and
just see if we get lucky and hit on something that will work.
Because there is a lot of literature about how you treat
chronic fatigue syndrome and fibromyalgia and some of these
other diseases that look a little bit like this. So there are a
lot of things they could try, and if they had a systematic
approach they might be able to really come up with a
breakthrough just by luck.
On the other hand, what our program is doing is trying to
go step by step to slug out this hard science and get to the
bottom, get to the mechanisms both of what is going on in the
brain and then what do these chemicals do to the inside, to the
machinery of brain cells just like in Parkinson's disease, then
see if we can engineer a treatment, but that is going to be a
longer effort.
And so in the meantime we ought to be aggressively triaging
these people based on their symptoms and then having a program
to try to try different treatments for them. You think, Bobbie?
Dr. White. Well, I do have two suggestions. One would be to
continue some of the funding started by CDMRP and other
agencies focused on treatment trials; those can be empirically
based or mechanistically based. We do have some theories about
the mechanisms underlying Gulf War Illness that are amenable to
treatment approaches. So that is one research way we could go
about this, that is to systematically look at treatment
possibilities.
My second suggestion would be clinically based in terms of
educating VA physicians again with probably a new program. And
secondly, developing a set of experts to which Gulf War
veterans could be referred for specific work-up. So people who
are experts in the effects of chemicals on health, people who
are experts in the pulmonary consequences of different kind of
exposures, people who do neurological evaluations of people
with multi-symptom illnesses.
So I think there needs to be a well-thought-out research
approach and a well-thought-out clinical approach in order to
deal with the problem. And I think there are things that could
be done right now. We need more science, but we also need to
just move.
Mr. Hardie. And may I add to that? Add as well of
advisements on what to avoid. Avoid DEET. I mean, it makes me
ill, it makes my fellow Gulf War veterans ill. Avoid KILZ when
you are covering the paint on your wall and you want to put on
the new primer, avoid that.
VA has done a wonderful job of updating its Web site here
recently for Gulf War Illness in the last week or so, and they
have a new structure. The clinician's guide unfortunately is
still outdated, and I know that there is a new VA official I
was just sitting next to who is coming into a big job and it
would be great if VA would take on that task of fixing the
clinician resource. I sure wouldn't want one of my buddies
walking in the VA hospital now and being seen by a doctor whose
only experience was that outdated clinician's guide.
Mr. Adler. I thank you for that comment. One more question,
is that all right?
Mr. Hardie, this is just to you. What are you presently
service-connected for? And do you think that is the right
category?
Mr. Hardie. Sure, I am service-connected for a list of
things. I had a non-combat related issue for which I was at
Walter Reed for more than a year with my lower leg. That was
purely a muscular and venous issue and so I am okay with that.
But I am also service-connected for post-traumatic stress
disorder at 30 percent, which is similar for--most of the guys
I served with in Somalia have a similar diagnosis. I am
service-connected for fibromyalgia, chronic fatigue syndrome
and irritable bowel syndrome. I would like to highlight that
for VA you can only be service-connected for fibromyalgia, or
chronic fatigue syndrome, they are both at 40 percent together,
but the fact that even though my fibromyalgia and chronic
fatigue are so debilitating that I am no longer able to work, I
was an executive at the Wisconsin State Department of Veterans
Affairs, an agency of about 1,200 up until just a few months
ago, the maximum as I understand is 40 percent, irritable bowel
at 10 percent. I am service-connected for asthma. I don't have
asthma. I appreciate the fact that some VA clerk somewhere
service-connected me for asthma because I had a misdiagnosis of
asthma of 10 percent back in the military. I have never had
asthma. They called it post-exertional asthma since they didn't
know what to do with it. I filed repeatedly, I have stated in
my VA claims paperwork I don't have asthma. I have an
undiagnosed lung condition, which was finally diagnosed this
March. The irony of that diagnosis of COPD, chronic obstructive
pulmonary disease, is that now I am no longer able to get
service-connected under the undiagnosed illness provision. So I
guess I am service-connected for asthma and that is where it is
going to be.
Mr. Adler. I thank you for that.
Mr. Hardie. I may have forgotten some as well. There are a
couple smaller ones in there somewhere.
Mr. Adler. I think we made our point together. Thank you,
sir.
Mr. Hardie. Thank you.
Mr. Adler. I yield back.
Mr. Mitchell. Thank you very much. And again, I would like
to express the gratitude of this Committee and our country for
the work you are doing and researching and trying to get to
this. And Mr. Hardie, thank you for your service. Thank you.
Mr. Hardie. Thank you.
Mr. Mitchell. I would now like to welcome panel 3. For our
third panel we will hear from Doug Dembling, Associate Chief
Officer for Program Coordination, Office of Public Health and
Environmental Hazards for the Veterans Health Administration,
U.S. Department of Veterans Affairs. Mr. Dembling is
accompanied by Dr. Victoria Cassano, Acting Chief Consultant
for the Environmental Health Strategic Health Care Group,
Veterans Health Administration; Dr. Joel Kupersmith, Chief
Research and Development Officer, Office of Research and
Development, Veterans Health Administration; and David Barrans,
Deputy Assistant General Counsel, U.S. Department of Veterans
Affairs.
And if we will, we will begin with Mr. Dembling and you
will have 5 minutes. Thank you.
STATEMENTS OF DOUGLAS E. DEMBLING, ASSOCIATE CHIEF OFFICER FOR
PROGRAM COORDINATION, OFFICE OF PUBLIC HEALTH AND ENVIRONMENTAL
HAZARDS, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF
VETERANS AFFAIRS; ACCOMPANIED BY VICTORIA ANNE CASSANO, M.D.,
MPH, ACTING CHIEF CONSULTANT, ENVIRONMENTAL HEALTH STRATEGIC
HEALTHCARE GROUP, OFFICE OF PUBLIC HEALTH AND ENVIRONMENTAL
HAZARDS, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF
VETERANS AFFAIRS; JOEL KUPERSMITH, M.D., CHIEF RESEARCH AND
DEVELOPMENT OFFICER, OFFICE OF RESEARCH AND DEVELOPMENT,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
AFFAIRS; AND DAVID BARRANS, DEPUTY ASSISTANT GENERAL COUNSEL,
OFFICE OF GENERAL COUNSEL, U.S. DEPARTMENT OF VETERANS AFFAIRS
Mr. Dembling. Good morning, Mr. Chairman. Thank you for
this opportunity to discuss VA's work in studying the illnesses
of Gulf War veterans. I am accompanied today, as you pointed
out, by Dr. Joel Kupersmith, Dr. Victoria Cassano, and Mr.
David Barrans.
My written statement, which I submitted for the record,
provides background information on Gulf War veterans, explains
VA's relationship with the Institute of Medicine, discusses VA
and IOM agreements with regard to animal studies, describes the
range of services and benefits available to Gulf War veterans,
and outlines Federally sponsored research related to Gulf War
veterans.
In the few minutes that I have, I would like to make
several points. In following the laws Congress passed, VA has
utilized the National Academy of Sciences, Institute of
Medicine, for almost two decades to evaluate potential
associations between environmental hazards encountered during
military deployment and specific health effects.
Congress directed us to work with IOM initially regarding
Agent Orange and urbacide exposures of Vietnam veterans, and
later regarding the various exposures experienced by Gulf War
veterans.
IOM's work has allowed VA to recognize approximately a
dozen diseases as presumed to be service-connected allowing
veterans who where in theater during the relevant period to be
compensated for these conditions without having to prove their
connection to service.
Since Congress directed VA to enter into an agreement with
IOM to review and evaluate the available scientific evidence
related to Gulf War veterans, nine IOM committees have
generated comprehensive reports on Gulf War veterans health
issues. This work has allowed VA to presume service-connection
for conditions includes ALS, and under forthcoming regulations
nine infectious diseases.
Current law already provides presumptive service-connection
for Gulf War veterans, undiagnosed illnesses, or unexplained
chronic multi-symptom illness regardless of whether the
condition can be causal linked to a specific exposure in the
line of duty.
IOM is an independent world-class organization. They put
their analysis through rigorous internal and external review.
VA relies on their determinations and has confidence the
methods they used to conduct their assessments. When VA
contracts with IOM we defer to their professional opinions
concerning methodology so they maintain that independence.
IOM reports consider the available research, including both
human and animal studies to guide their findings about whether
there is evidence of an association between exposure to a
substance or hazard and the occurrence of an illness, and
whether there is a plausible biological mechanism or other
evidence to support that connection.
There have been some concerns expressed that VA may have
instructed IOM to disregard animal studies in their scientific
assessments; this is a misperception. In reviewing all of the
contracts for the nine IOM studies, there is no language in the
contracts, including the statements of work, that either
requires or requests IOM to disregard animal studies. VA has
provided this Subcommittee with the statements of work for both
the Gulf War and Agent Orange IOM studies.
The standard procedure for all VA contracted IOM committee
studies is to leave each independent committee completely in
charge of deciding what research to include and how to
interpret it.
VA takes the illnesses of Gulf War veterans very seriously
and has established a robust research program to study these
illnesses. VA had spent over $20 million in support of research
on Gulf War veterans' illnesses in both fiscal years 2007 and
2008. Research is an important element of our support for
veterans, and by turning information into action, VA directly
improves the care of America's veterans. VA trains its
providers to respond to the specific health care needs of all
veterans, including Gulf War veterans with difficult to
diagnose illnesses.
Moreover, every VA Medical Center is required to have an
environmental health clinician available to discuss any
concerns veterans or providers may have regarding combat
theater exposures.
VA distributes similar information to providers through
newsletters, brochures, conference calls, and the war-related
illness and injury study centers to educate providers to the
unique needs to combat veterans.
In conclusion, Mr. Chairman, Congress has directed VA to
utilize IOM's independent evaluations of research when making
determinations about Gulf War veterans' illnesses. IOM is a
nationally recognized authority in analyzing clinical research,
and we rely on their ability to provide sound assessments.
At the same time Secretary Shinseki recognizes that this
well-established process takes time. He has asked VA staff to
review this approach and determine if there are additional ways
to more rapidly uncover the data necessary to determine a
connection between exposures and military service and specific
health outcomes.
Thank you for the opportunity to testify. My colleagues and
I are prepared to address any questions you or any of the other
Committee Members might have.
[The prepared statement of Mr. Dembling appears on p. 79.]
Mr. Mitchell. Thank you. Dr. Kupersmith?
Dr. Kupersmith. Yes, I do not have an opening statement. I
was a late entry in this as a witness, and we agreed to have to
statement in within the next few days.
[The prepared statement of Dr. Kupersmith appears on p.
83.]
Mr. Mitchell. Thank you. A couple questions. First of all
to Mr. Dembling. You heard from all three panels. First of all
that there was an agreement on the first panel, the RAC and the
IOM, that there is a multi-symptom case which they all agree
called Gulf War Syndrome. I got that nod from both of them. So
there is such a thing as a multi-symptom Gulf War Illness.
And you heard from the second panel that what these
veterans are after, they are not after disability, they are
after a cure. They want to get back to a normal life. And you
heard from Mr. Hardie that it has taken 18 years and he is
still trying to get the services he needs.
In your statement you are really going back and defending--
that is fine--IOM and so on.
Let me tell you, from what I have gathered here, and I want
to quote the statute that Mr. Binns was referring to. It says,
and this is under section 1602, the presumption of service-
connection. It says, ``This section is to warrant a presumption
of service-connection by reason of having a positive
association with exposure to a biological chemical or toxic
agent.'' And then it goes on to say, and it talks about the
exposure of human or animals to a biological chemical and so
on. ``The Secretary shall take into account reports submitted
by ``--all the groups that we have talked about--'' and other
sound medical and scientific information and analysis available
to the Secretary. An association between the occurrence of an
illness in humans or animals and exposure to an agent, hazard,
or medicine or vaccine shall be considered to be a positive for
purposes of this subsection if the credible evidence for the
association is equal to or outweighs the evidence against the
association.'' And as Mr. Binns said, if it is about equal
deference should be given to the veteran.
We are hearing, you know, that they are still having
trouble in the VA of trying to get the services they need for
these particular illnesses.
Now my question is, how does the VA plan to mediate the
differences between these two different reports and how it will
affect veterans? How do you plan on mediating these
differences? You just can't fall back and say we are only going
to take one or the other. Both of these groups were authorized
by Congress. And the question is what are you going to do about
it?
Mr. Dembling. That is a good question, Mr. Chairman. And
Congress has directed us, as you know, to work with the
Institute of Medicine and getting updates on a periodic basic
and use those updates to make determinations about presumptions
of service-connection, which we have done. Going back to the
years where we were doing these studies using Agent Orange. And
it is our expectation, and I think as you heard from Dr.
Goldman, that there will be a discussion of the underlying
scientific research. We don't anticipate that IOM will review
the review of previous scientific----
Mr. Mitchell. They are not doing that.
Mr. Dembling. They are not doing that. They will be
reviewing the scientific literature.
Mr. Mitchell. So you are only saying that you are going to
look at the IOM. What about the RAC? That is also established.
They have some credibility.
Mr. Dembling. Right.
Mr. Mitchell. So what are you going to do with them?
Mr. Dembling. Well let me yield to Dr. Kupersmith, he
handles the research portfolio for us. It is a Research
Advisory Committee. Their views and recommendations have been
taken into consideration by VA over the years.
I think with regards to this specific issue of whether
there is a causal relationship--a cause for the unexplained
illnesses of veterans or not, we want to see the next report
from the Institute of Medicine, which will consider any
scientific evidence that wasn't considered in their previous
reports that VA's Research Advisory Committee might have used
in coming to their determinations. And they will be reporting
to use in early 2010, and we expect that they will consider all
the research that was conducted up to that point.
Mr. Mitchell. In the meantime what happens to people like
Mr. Hardie? You know, he had to go out on his own to find out
that he had a bronchial problem, and now he can't get any kind
of service for that. He has been there over 18 years. How many
more studies? You know, you really haven't answered. What are
you going to do with the RAC report?
Mr. Dembling. Dr. Cassano is a physician, she is heading up
our Environmental Health Program.
Mr. Mitchell. Yes, but you are the one in charge of the VA,
right?
Mr. Dembling. You are specifically asking about health care
and what can be provided to veterans for health care. Let me
see what Dr. Cassano can say about that.
Dr. Cassano. As Mr. Dembling had previously mentioned,
there are two different focuses. What we do with the IOM has
been demonstrated here in the first Committee. The RAC is
supposed to advise Dr. Kupersmith's group regarding the
direction of future VA research.
I think the best way to resolve these issues, as we have
already initiated a dialog between both IOM and the RAC, to
discuss how they came up with different conclusions. The RAC
report did review more current literature than the IOM did.
That may be part of the problem, and we recognize that.
However, once we get this report in February, we will review
that report and see if there are still differences and we will
have to decide at that point which evidence--what evidence we
are going to use, but that involves a process. It is the same
process. Whenever we get a report, either if it is Agent Orange
or Gulf War, there is a process that VA goes through to analyze
the results of those reports.
Mr. Dembling. And at the time----
Mr. Mitchell. Did you hear Dr. Haley's comment about
research, how you happen to get to it and the people he is
dealing with, that these are real symptoms, and Mr. Hardie went
through the same thing? And you are just going to sit and rely
strictly on what the IOM says?
Mr. Dembling [continuing]. Just because there may be a lack
of understanding about the cause of certain illnesses or
diseases doesn't mean we can't treat them and provide services
and health care to veterans, and that is what we are doing at
our VA Medical Centers every day.
Mr. Mitchell. Okay. But let me tell you, there is a
perception among far too many Gulf War veterans that when they
go in to the VA that they just keep--who is supposed to help
them improve their health, that they are just getting
procedural excuses, and they just keep getting put off. That is
the perception.
Mr. Dembling. Okay.
Mr. Mitchell. Now if it is not true, VA has a lot of work
to do to overcome this and that is your job.
Mr. Dembling. Absolutely. And there may be cases where
veterans did not get the services that they should be getting
and we want to know about them. If there are specific examples
of veterans not getting services we can follow up on that.
One of the things that we have set up----
Mr. Mitchell. One at a time. Two hundred and fifty thousand
people and you are going to do one at a time.
Mr. Dembling [continuing]. Well one of the things that we
have done that was established shortly after the Gulf War
hostilities were over was to establish referral centers for
veterans that had difficult to diagnose illnesses. That has
been expanded. We now have three War-Related Illness and Injury
Study Centers that provide comprehensive physical examination
and work ups to veterans that may have conditions that are
difficult to diagnose and understand. And that is an exhaustive
process that tracks these veterans and follows up for their
care and then makes recommendations back to their primary care
physicians.
So we are trying to provide the services that we can to
those veterans even in the absence of information that tells us
specifically what might have caused their illnesses.
Mr. Mitchell. But as I said, the perception of many Gulf
War veterans is that they are just getting procedural excuses
and not getting the service that they need.
Mr. Dembling. And I think what we need to do is a better
job of education for our health care providers and our
clinicians. And one of the things that I think Mr. Hardie
mentioned has to do with the Veterans Health Initiative (VHI),
the clinical guides that we use, and those are going to be
updated. We are working with our Employee Education System to
get those VHIs updated as quickly as we can and we are working
on that as well.
Mr. Mitchell. And this may be to Dr. Kupersmith. In the
2008 annual report to Congress it states that it was obligated
to the VA for Gulf War Illness research a total of $21.6
million. Of this $21.6 million, $15 million of it has been
allocated to Dr. Haley's study specifically, and that leaves
$6.6 million for all the other ongoing Gulf War research. Is
that enough?
Dr. Kupersmith. Well let me just first say, I think as you
referred to the report, we are in agreement with the reports
recommendations concerning our research direction and how we
should be doing it. And also, I----
Mr. Mitchell. In agreement with who?
Dr. Kupersmith. The report, the RAC report that you just
quoted.
Mr. Mitchell. The RAC.
Dr. Kupersmith. Yes.
Mr. Mitchell. Okay.
Dr. Kupersmith. This includes research into sophisticated
imaging techniques such as what Dr. Haley has talked about. He
is doing it, it is being done in centers also. Genomic studies
we think are very important because one of the--you know, over
the years there had been tremendous frustration in research
results, but one of the things that may be true is that certain
individuals had genetic predispositions to these exposures.
That will also help us with what might be the mechanism or way
that these exposures exert the effects that they do. So we are
in general agreement with one point after another.
I think the recommendation was that we spend approximately
$20 million, which we are, as you said. We have new initiatives
now. New initiatives in the treatment of Gulf War disease. New
initiatives in other areas. So we are evaluating our budget for
next year.
Mr. Mitchell. Well let me ask, do you feel that the $6.6
million is adequate for the rest of the research?
Dr. Kupersmith. Well that has been our analysis up to now,
but we will be seeing what research we can do within our
system, and if it requires more funding we will certainly give
it.
Mr. Mitchell. One last question before I turn to Dr. Roe.
The VA's three largest Gulf War research projects that are
ongoing--there are three I understand--could you give us the
status of each and the dollar amounts that have been spent and
let us know what it is the VA gets out of this?
Dr. Kupersmith. Well let me say, I think, you know, we have
examined over these last 18 years what research has been done.
The research agenda has in general been set by the deployment
health working group, which is a group of experts from the
Department of Defense and the VA. That was soon after the Gulf
War that began. It is clear, as everybody has said here, that
it has not accomplished the goals of finding what we might call
a silver bullet for the treatment of Gulf War veterans'
illness, and for determining the many other aspects of it. So
we are undertaking new areas.
And all of us are very much in agreement with Dr. Haley
with what he said, with what Dr. White said, what Mr. Binns
said concerning the need for approaching these in new ways. So
we are undertaking sophisticated imaging studies as we said.
The state-of-the-art imaging correlations with tests of brain
function. Genomic studies, we feel, may be very important to
solving some of the issues related to what is susceptible and
indicating who had an adverse outcome from this. Studies to
determine biomarkers, which are diagnostic tests that may show
us who had the disease. Because it is clear, as has been
testified to in the previous hearing, that it will be very
difficult to analyze the exposures now 18 or 19 years later.
Those are just some of the areas that we are getting into.
And this represents the use of new technology, some of which
has been developed in the VA to try to address these problems.
Mr. Mitchell. In terms of research dollars, could you tell
me how much has been allocated to TBI and PTSD compared to Gulf
War research?
Dr. Kupersmith. I think they were submitted. And I
apologize, I do not have the exact numbers with me. I can give
you those, and I would rather----
Mr. Mitchell. Can you give me ballpark figures?
Dr. Kupersmith. You know, I would rather not say, because
you know, I will be quoted. I apologize for that. I could get
these very quickly for you, I just don't have them in my head.
I know they were submitted.
Mr. Mitchell. All right, I would like to see those.
Dr. Kupersmith. We will certainly do that.
[The information is provided in Question 4 of the Post-
Hearing Questions and Responses for the Record, which appears
on p. 121.]
Mr. Mitchell. Thank you.
Dr. Kupersmith. I apologize for not being able to quote
them from memory.
Mr. Mitchell. Dr. Roe.
Mr. Roe. I apologize for having to step out for a moment,
but I guess the conclusion I am coming to in listening to this,
and obviously as I said last night I couldn't read that volume
of information. But I guess in the VA system now, how are Gulf
War veterans with this presumed illness being treated? When
they come in, I mean, is there a clinic or an expert? We have a
VA facility in my hometown, Mountain Home VA in Johnson City,
Tennessee, and I haven't asked them that. Is there a standard
methodology of treatment?
For instance, we talked a lot about electronic medical
records and evidence-based medicine. Well we are gathering
evidence now about this and ongoing research and millions of
dollars have been spent. And I guess what I worry about is if
we spend millions and millions and millions of dollars and
don't have any more conclusions than we have now and maybe we
are denying veterans care by spending the money, that is my
concern. I have watched that happen over and over.
And I know from doing clinical research, Dr. Haley had
mentioned this a minute ago, you know, sometime we just stumble
on a treatment and it works and then sometimes you do animal
studies--I mean, from level one all the way through and spend a
billion dollars with a new drug and find out it doesn't work.
So do we have any treatment guidelines in the VA right now
that if I went back to the clinic at home and put my
stethoscope on again, there's a methodology I can use to treat
a veteran that comes in with these symptoms?
Dr. Kupersmith. You know, I deal with the research part of
it.
Dr. Cassano. Dr. Roe, let me step a back a little bit and
discuss the progression. Before there was ever an IOM report on
Gulf War, we had asked Congress for special authority to
service-connect undiagnosed illnesses, which now includes 13
different sets of symptoms, as well as fibromyalgia, chronic
fatigue syndrome, and irritable bowel syndrome, which are
considered the unexplained chronic multi-symptom illnesses.
Since that time, we have gotten IOM confirmation of the three
unexplained illnesses, fibromyalgia, chronic fatigue syndrome,
and irritable bowel syndrome associated with Gulf War service,
to further suggest service-connection.
At about the same time, however, we realized that we needed
to find a way to care for these veterans. There were several
initiatives started.
First of all the VHI, which was the training program for
veterans, does need to be updated, but that is out there for
clinicians who take care of veterans from the Gulf War to look
at. We have about 15 VHIs. There is one specifically for Gulf
War.
In addition, the environmental health clinician is
specifically in the clinic to be able to take care of those
post-deployment related issues whether it is Gulf War or Agent
Orange or some of the issues from the current conflict. They
are in every VA Medical Center. They actually are used on the
front line along with the primary care doctor to look at
various symptoms and various illnesses and see what proper
treatments are necessary.
In addition, we started the War-Related Illness and Injury
Study Centers which are the referral centers Mr. Dembling spoke
of. They are more than just a referral center. They are really
the subject matter experts on unexplained and undiagnosed
illness. So they act not only as a referral clinic, but also as
a subject matter expert with the primary care docs and the
environmental health clinicians so that their expertise is
utilized on the front lines when somebody comes in with a
possible illness or symptom related to the Gulf War.
In addition, all of our conferences--we have a new
conference coming up--the Evolving Paradigms conference in
September that will deal with these issues specifically so that
we continue to train our clinicians that we are not just taking
care of a patient in a veterans health care system, but we are
taking care of veterans in a veteran specific, veteran centric
health care system.
Mr. Roe. I know one of my pet peeves when I practiced
medicine and I saw someone that came in, if we don't know what
was wrong with you, we either said you had a virus or it is
between your ears, when we didn't know. And as several have
pointed out, MS is a perfect example of people you see that
have a symptom and it may take 10 years to diagnose that
patient because of evolving symptomology, and that is one of
the things I said at the last meeting, was that we need to
continue to follow this to gather this evidence over a
lifetime.
But also I think what we need to do is now get as concise
as we can the set of symptoms, educate our clinicians and our
practitioners, and get this care to veterans. And also continue
the research.
The biggest problem we have in disease, if we don't have an
etiology, it is very hard to treat something. I know a lot of
non-clinical people don't understand that. But if I know you
have pneumococcal pneumonia I can treat that. The problem is
when you have a symptom over here, and a symptom over here is
trying to, number one, get an etiology, and then get an
effective treatment program.
So I would suggest that we deal with the knowledge that we
have, and in 10 years we may look back if we continue to gather
this information and say, how in the world did we ever draw
that conclusion? I have done that before. I've looked back and
thought that treatment was totally wrong. But I think that is
what needs to be done from what I have heard now and put
together.
And I think our third meeting, Mr. Chairman, I think we
need to push in that direction. I yield back.
Mr. Dembling. We agree with you completely, Dr. Roe, that
is why we have the vigorous research program under way, we have
education programs under way for our providers, and as Dr.
Cassano mentioned, a massive conference--the Evolving Paradigms
conference--it will be held in September that will educate over
a thousand providers and health care folks from around the
country as to the new experiences of combat veterans. And at
the same time providing health care to the maximum extent
possible that we can in our Medical Centers with the knowledge
that we have and that we have learned over the past few years.
Mr. Roe. Yeah, understanding that it is imperfect. I think
as I have had a chance to think, and I will think more about
this, I believe this is a bell-shaped curve and you have some
people out here who don't have Gulf War Syndrome who will
exhibit some symptoms. I believe that, and you are going to
include some of those in payment, so be it. We can't get
everything right with something that is hard to diagnose as
this. But I truly do believe we have to get this particular
group of veterans that probably do have something, whatever it
is, and try to do something for them.
And again, I went through this at the end of Vietnam, I am
a two-ID guy from Korea and I watched this happen to a group of
veterans. It doesn't need to happen again. And I think good
people are trying, I really do. I don't think they are ignoring
it. And I think Mr. Hardie, I think his problem is that, it is
been almost 100 years since we have had people breathe Mustard
Gas or inhale it.
So I hope we do that, and I hope we are able to, Mr.
Chairman, come to a conclusion here after our next hearing and
give some real solid recommendations so that we can get this
information in the clinical room, in the treatment room for the
patient.
Thank you all very much and I yield back.
Mr. Mitchell. One thing I would just like to finish with. I
don't doubt at all the research and the methodologies that Dr.
Goldman and Dr. Steele were going through. And you know,
sometimes we are arguing over how many angles dance on the head
of a pin instead of getting down to what really matters, and
that is treating the veteran, those who have Gulf War Symptoms.
And as I mentioned earlier, the perception of far too many
Gulf War veterans is that the VA has nothing new to offer
except procedural excuses.
And I just want to quote one last thing out of the statute.
And I know, Dr. Cassano, you are talking about relying on IOM
and so on, and this is where I think sometimes people talk
about the excuses and putting things off. It is been a long
time since we have had that war. And I just want to quote this
one section. It says, ``Under section 1603 of the Persian Gulf
War Veterans Act 1998, the Secretary shall determine whether or
not a presumption of service-connection is warranted for each
illness.''
They can do it. You can do this. You don't need an Act of
Congress. It is up to you. And I really feel bad when we take a
look and see how some veterans perceive the lack of service and
we hide behind again all of the little details when they are
out there being disabled and can't work and can't function
properly. And I think that the VA has got to take--and I really
appreciate the research that Dr. Haley and others are doing,
because this goes far beyond--you know, the research that has
developed here and the results, far beyond the veterans, it
goes to the whole humanity, and that is what is important. And
don't get hung up on that. We have soldiers out there, veterans
who need help.
I would like to thank all of our witnesses for testifying
here today. And it is evident from our last hearing and from
this hearing that this is still an issue of utmost importance
to all of our veterans.
In our first hearing we looked at the history. Today we
looked at the science. And now it is time to move forward and
provide answers for those that sacrificed for our country over
18 years ago.
Our next hearing will focus on benefits and the lessons we
have learned from both Agent Orange and Gulf War research.
These are lessons we need to apply not only to our Gulf War
veterans suffering here today, but also to the brave men and
women fighting in Iraq and Afghanistan today.
It is essential that we get this right so that 20 years
from now down the road we are not having these same discussions
again.
And again, I want to thank all of our witnesses for joining
us today. Dr. Roe.
Mr. Roe. And just one final comment. Mr. Chairman, thank
you for having this very important hearing and hopefully we
will have some recommendations in the very near future. And
once again, thank you for having this and I thank all the
witnesses too for being here.
Mr. Mitchell. Thank you, this hearing is adjourned.
[Whereupon, at 12:24 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
Prepared Statement of Hon. Harry E. Mitchell, Chairman,
Subcommittee on Oversight and Investigations
Thank you to everyone for attending today's Oversight and
Investigations Subcommittee hearing entitled, the Implications of U.S.
Department of Veterans Affair's Limited Scope of Gulf War Illness
Research.
It has been upwards of 19 years since the United States deployed
nearly 700,000 service Members to the Gulf in support of Operations
Desert Shield and Desert Storm. When these troops returned home, some
reported symptoms that were believed to be related to their service and
possible exposure to toxins, agents, and chemicals. However, the amount
and combination of these chemicals used during this period is unknown
and conflicting research has created a real challenge for being able to
prove a veteran's symptom resulted from service connection.
As a result, there are many veterans with undiagnosed illnesses and
multi-symptom illnesses relating to their service in the Gulf War who
are still suffering from chemical agent exposure, and are finding
themselves fighting the VA to have Gulf War Illness recognized as
service connection and compensation.
As many of you know, in May of this year, this Subcommittee held
its first of a series of hearings to address this issue. During that
hearing we examined the impact of toxins and pesticides used during the
Vietnam and Gulf Wars. And with a growing chorus of concern over the
accuracy of existing research, I believe it is time for us to take an
in depth look at the scientific research surrounding Gulf War Illness
Research.
Today's hearing will focus on how the current research is
progressing, including taking a closer look at the reports offered from
the Institute of Medicine (IOM) and the Research Advisory Committee
(RAC). In addition, the hearing will examine the VA's role in treating
Gulf War Illness.
There are few things that I would specifically like to examine
today. First, did VA and IOM meet congressional mandates and the
essence of Public Laws 105-277 and 105-368 to include animal and human
studies, along with evaluating diagnosed and undiagnosed illnesses?
Second, were methodologies used by IOM equivalent in both Agent Orange
and Gulf War studies? And third, I would like to examine the
methodologies utilized in production of the RAC report.
We have learned and will continue to learn that Gulf War Illness
Research is a challenge, but a missing link appears to be a lack of
documentation of exposure and compounds that exposed our veterans.
Additionally, we are waiting for science to bridge the gap between self
reported illnesses and diagnostic evidence, just as we did with Agent
Orange veterans.
Our last hearing on this issue shed light on the fact that we
aren't doing enough for our Gulf War Veterans and that they continue to
fight for what they deserve. Today, I am hopeful that we will all
examine this issue with open minds and get one step closer to a
consensus amongst Congress, VA, scientific bodies, and most
importantly, our veterans.
For today's hearing, we have brought experts from all fields to
discuss this important issue. I am hopeful our panelists here today
will discuss the merits of the RAC report in comparison with IOM
methodologies and the results of both, as well as discuss the best
course to ensure that this important research will benefit veterans.
I'm anxious to hear from the VA what actions they have taken in
response to the RAC report, and more importantly, how the questions
surrounding Gulf War research affect our veterans and how the VA plan
to move forward.
While I praise all of our panelists here today for the research
work they are doing on behalf of our Gulf War veterans, we must find a
way to give these veterans the answers they have been looking for since
returning home from theater almost 20 years ago.
Prepared Statement of Hon. David P. Roe, Ranking Republican
Member, Subcommittee on Oversight and Investigations
Mr. Chairman, thank you for yielding me time.
As you indicated in your opening statement, this is the 2nd of a 3-
part hearing series on Gulf War Illness Research. The focus and title
of this 2nd hearing is the ``Implications of VA's Limited Scope of Gulf
War Illness Research.'' While I'm not sure that VA has had limited
scope in the area of Gulf War illness research, I appreciate you
calling this hearing to further evaluate the research that has been
completed and reviewed, not just by the Research Advisory Committee on
Gulf War Veterans' Illnesses, but also by the National Academy of
Sciences, Institute of Medicine. I understand that both organizations
are represented here today as witnesses.
As a follow up to our first hearing, we have received responses to
questions for the record from Dr. Roberta White, from Boston
University, Dr. Lea Steele from Kansas State University, Paul Sullivan
of Veterans for Common Sense, as well as the VA. I appreciate that we
received their responses prior to today's hearing. Their input from the
last hearing is important information to have as we proceed today.
On Tuesday afternoon, the Committee also received the Secretary's
``Annual Report to Congress on Federally Sponsored Research on Gulf War
Veterans' Illnesses for 2008.'' This report is also important for us to
review, as it reflects the large body of work that is continuing on
this matter. From FY 1992 through FY 2008, the VA, the Department of
Defense, and Health and Human Services funded 347 distinct projects
relating to health problems affecting Gulf War veterans. As of
September 30, 2008, 288 of these projects were completed, and 59
projects were either new or ongoing. I am pleased we received this
report prior to today's hearing.
I am looking forward to a lively discussion today, as we have
representatives here from several different scientific backgrounds,
representing different studies on Gulf War Illness, and the possible
causes. I am pleased, Mr. Chairman that you have decided to include in
this hearing the Institute of Medicine representatives, who have
compiled large volumes of material on Gulf War Illness, possible
causes, and comorbid diseases which may or may not have come from
exposures during the first Gulf War. I am interested in learning
whether these same exposures were also present during the current
conflict and what we can expect, as the authorizing Committee, as to
new presumptions for exposures in both conflicts.
I would like to remind my colleagues as we proceed that we must
throughout this series of hearings keep an open mind as to the reports
and studies being presented to us, and the way ahead for us as the
authorizing Committee for benefits and services provided to our
Nation's veterans.
Again, Mr. Chairman, I appreciate your diligence in pursuing these
hearings and yield back my time.
Prepared Statement of Hon. John J. Hall
Thank you for yielding Mr. Chairman, and thank you to the witnesses
who have taken the time to come here today to discuss a very important
issue to our Nation's veterans.
We are here today because of an issue that we can all agree
deserves our utmost attention. Gulf War Illness has had a crippling
effect on approximately 200,000 veterans of the 1991 Gulf War. Since
1998, the VA has funded independent studies by the Institute of
Medicine in order to find out how best to address the health problems
that Gulf War veterans are suffering from.
Unfortunately, there has been disagreement between the IOM and the
VA's Research Advisory Committee on how to approach this research. In
particular, the RAC feels that the IOM studies were too narrow, not
satisfying the requirements set out by Congress. The IOM's emphasis on
human studies versus animal studies and not focusing on undiagnosed
illnesses are some of the issues delaying a final report.
I am very concerned about these disagreements, and the impact they
are having on providing adequate care and compensation to our veterans.
Many veterans are being turned away from VA hospitals, and being denied
treatment, because there is no way to properly diagnose their illness.
An uncertain method of diagnosing Gulf War Illness also complicates the
compensation process. Compensation is critical when it comes to caring
for our veterans, and making sure they are able to live their lives to
the fullest.
I understand that these disagreements are important to resolve. A
scientific consensus will allow the VA to better treat those who suffer
from Gulf War Illness and related injuries. My worry, however, is that
in the meantime, while the VA and the IOM seek to reach that consensus,
veterans are suffering. I hope that we will hear today that at the very
least the RAC and the IOM can agree that there is no time to waste. I
look forward to the solutions that I hope this hearing will provide.
Prepared Statement of Lynn Goldman, M.D., MPH, Professor,
Bloomberg School of Public Health, Johns Hopkins University,
Baltimore, MD, and Member, Committee on Gulf War and Health,
Institute of Medicine, The National Academies
Good morning Mr. Chairman and Members of the Subcommittee. Thanks
to Congressman Mitchell and Members of the Subcommittee on Oversight
and Investigations, House Committee on Veterans' Affairs for your
concern about veteran's health.
My name is Lynn Goldman. I am a professor of environmental health
sciences and epidemiology at the Bloomberg School of Public Health at
Johns Hopkins University in Baltimore and chair of our program in
applied public health. Prior to joining Hopkins in 1999 I served for 6
years at the U.S. Environmental Protection Agency (EPA) as Assistant
Administrator for the Office of Prevention, Pesticides and Toxic
Substances. My primary training is in pediatrics and epidemiology. I
also have served as Chair of two Institute of Medicine (IOM) Gulf War
and Health Committees: the Committee that worked on the report Gulf War
and Health: Review of the Medical Literature Relative to Gulf War
Veterans Health, and the Committee that produced the report Gulf War
and Health: Fuels, Combustion Products, and Propellants. Additionally,
I was a Member of the Committee that produced Gulf War and Health:
Insecticides and Solvents. I am here before you today because of my
experience as a volunteer serving on those IOM Committees and as an
elected Member of the Institute of Medicine.
I will focus on four main points in my testimony. First I will
discuss the overall study process, including the review process, for
the Gulf War series of reports and how that process compares to the
study process for the IOM Agent Orange reports, including the report
review process. Second I will discuss the categories of association
used by the Gulf War & Health Committees to classify the likelihood
that exposure to a given agent is related to a given health effect, and
how those categories compare to those used by the Agent Orange
Committees. Third, I will discuss how scientific studies are used by
the Gulf War and the Agent Orange Committees, with a focus on animal
studies. Finally, I will discuss what is known about exposures during
the Gulf War and how that affects the Committees' work.
Let me begin with the IOM study process. The IOM is a division of
The National Academies, a non-governmental institution originally
chartered by President Lincoln to provide independent scientific advice
to the Nation. That scientific advice is usually in the form of
consensus reports produced by expert, unpaid Committees. In the case of
the Gulf War and Health and the Agent Orange studies, the Committees
usually comprised ten to twenty Members with expertise in epidemiology,
toxicology, exposure assessment and relevant areas of clinical
medicine. The Members are usually from universities, nonprofit
organizations, and consulting firms. The reports are developed through
an established study process designed to ensure Committees and the
reports they produce are free from actual or potential conflicts of
interests, are balanced for any biases, and are independent of
oversight from the sponsoring agency. At no time during a Committee's
deliberations or during the preparation and review of an IOM report is
the sponsor allowed to participate in the process or have access to any
part of the report. In cases where a Committee asks the sponsor for
information, any such information is made public.
Committees review relevant literature, hear from experts, and
deliberate. Once the Committee has reached its consensus, but prior to
the report being released, the draft report is subjected to a formal,
peer-review process. External reviewers are nominated by a broad range
of individuals including IOM and National Academy of Sciences (NAS)
Members, Committee Members and other interested parties. The list of
reviewers' is approved by a review oversight body, the National
Academies Report Review Committee, which ensures the reviewers have the
necessary expertise. The reviewers read the draft report and
individually provide comments on: 1) whether the Committee has
addressed its charge; 2) the strength of the evidence for and the
validity of the Committee's conclusions; and 3) the technical aspects,
clarity and flow of the report. Comments of the reviewers are provided
anonymously so that Committee Members and the study staff do not know
the source of the review comments when they receive them. In the case
of the Gulf War and Health and the Agent Orange studies, 10 to 15
experts in various scientific fields reviewed the reports. The
Committee must respond to each comment from each reviewer and indicate
what revisions were made to the report to address the comment or
provide a detailed explanation why the suggested revision was not made.
After all the comments have been addressed, each study Committee Member
must ``sign off'' on the revised report. The report is then sent to the
Review Monitor, who is a Member of the National Academies Report Review
Committee, and a Review Coordinator, who is assigned by the IOM
executive office. Those two individuals assess the Committee's response
to reviewers' comments and ensure that the Committee has adequately
addressed every comment. Only when they are satisfied is the final
report released to the public on their recommendation. A courtesy copy
of the final report is sent to the sponsor immediately prior to public
release. The sponsor is not provided an opportunity to review the
report or any portions of the report, or to suggest changes to the IOM
report prior to its release. This stringent and established process was
followed for both the Gulf War & Health and the Agent Orange reports.
In addition to those general procedures that are required by The
National Academies, each Committee also has procedures it follows in
reviewing the data and drawing its conclusions. Each Committee begins
its deliberations by discussing and developing an approach to the
Committee's statement of work. This statement of work has been approved
by The National Academies governing body and has been included in the
contract between the IOM and the study sponsor. However, in general
these statements of work do not detail the specific approach to be used
to complete the work, allowing the Committee to use its expertise to
identify the best approach. For the Gulf War & Health and Agent Orange
reports Committees needed to consider not only the statements of work
but also the requirements of the legislation mandating the studies in
developing approaches to how the Committee would gather, review and
evaluate the information it collects.
I can tell you from personal experience that the Members of the IOM
Committees take their responsibility to assess the scientific data in a
fair and unbiased manner very seriously. For each Gulf War and Agent
Orange report, the expert Committee Members reviewed, evaluated and
interpreted literally thousands of scientific publications that were
identified through comprehensive searches of electronic databases such
as those of the National Library of Medicine. On the basis of their
analyses and deliberations, the Committees reached consensus
conclusions. Each Committee prepared a consensus report outlining its
findings which includes descriptions of the methods it used, the
scientific information it reviewed, and the rationale for its
conclusions.
By direction of the U.S. Congress, most IOM Gulf War studies have
looked at chemical or biological agents or other possible deployment
exposures and have drawn conclusions about what adverse health outcomes
could be associated with or caused by those exposures. Similarly, the
Veterans and Agent Orange studies look at specific chemical agents
(Agent Orange and other herbicides) used during the Vietnam War and
draw conclusions about what adverse health outcomes could be associated
with or caused by those exposures. The conclusions are based on
categories of evidence. In both cases, the legislation requests that
the IOM Committees make conclusions on the strength of the evidence for
an association between exposure to certain agents and potential health
outcomes. Successive Gulf War Committees have decided to use the
following five categories of association to describe the weight of the
evidence and to make conclusions:
sufficient evidence of a causal relationship between
an exposure and a health outcome,
sufficient evidence of an association between an
exposure and a health outcome,
limited/suggestive evidence of an association,
inadequate/insufficient evidence to determine whether
an association exists, and
limited/suggestive evidence of no association.
Those categories evolved from the categories used by the Agent
Orange Committees, which in turn were adapted from established
categories of evidence used by the International Agency for Research on
Cancer when it ranks evidence for chemicals that may cause cancer. The
Agent Orange categories have gained wide acceptance over more than a
decade by Congress, government agencies, researchers, and veterans
groups.
The major difference between the categories used by the Gulf War
Committees and the ones used by the Agent Orange Committees is the
addition of the category of sufficient evidence of a causal
relationship for all but one of the Gulf War Committees. The additional
category makes causation explicit and includes evidence beyond that
found just in epidemiologic studies. Although association and causation
are often used interchangeably they have different meanings
scientifically. To demonstrate an association, the evidence simply must
indicate that as exposure to an agent increases, the occurrence of an
adverse outcome also increases. That an association is not the same as
causality can be understood using the following example: fire trucks
are associated with fires but they do not cause fires. For causation,
the evidence must demonstrate that the exposure leads to the health
outcome. For example, the influenza virus causes a person to get
influenza. Therefore, the categories of evidence used by the first and
subsequent Gulf War committees explicitly distinguish between causation
and association.
One other change the Gulf War committees made was to clarify the
definitions of Limited/Suggestive Evidence of an Association and
Sufficient Evidence of an Association. The Committee added the phrase
``in human studies'' to those definitions where they discuss ``chance
and bias, including confounding''. Chance, bias and confounding are
much more significant problems in human epidemiology studies than in
animal studies (which are more controlled). The addition of the
statement about human studies simply clarifies that point. Although
this phrase has been read to mean that the IOM studies have only
addressed human studies, in reality both the Agent Orange studies and
the Gulf War studies evaluate animal studies. This is quite evident
when you read the reports and review the references that have been
cited. At the same time, the IOM has put more weight on the human
studies than on the animal studies. The Gulf War and Health volumes
simply clarified that point, but conduct their studies in the same
manner as the Agent Orange studies.
This leads me to address the issue of how animal data have been
used by the Gulf War and the Agent Orange committees and why human
studies have been given more weight. First, as might be expected, the
published studies that are potentially relevant to the exposures
evaluated by the Gulf War committees include studies that are conducted
in animals. The committees looked at all relevant animal studies,
including published reviews of the animal studies. However, many of the
chemicals reviewed by the Gulf War committees have been tested in
animals for decades in hundreds of studies and have well-established
effects in animals that are described in basic toxicology text books.
In such cases, committees have sometimes determined that it was not
necessary to review all the individual animal studies that support
those established effects but instead to cite reviews that summarize
these specific well-established effects. Even in those instances where
the health effects of an agent are well known, however, the committee
still reviewed and described in their reports all of the animal studies
that are critical to the committee's conclusions.
Animal studies have been relevant and important but, there are
limitations when drawing conclusions in humans on the basis of data in
animals, which is why those studies were given less weight than human
studies. Animal studies sometimes provide very different information
than studies in humans. For example, vinyl chloride causes cancer in
different organs in animals than in human; arsenic is a known human
carcinogen but animals do not show similar tumors; and saccharine
causes bladder tumors in male rats but not in humans. Using animals to
look at human health effects is especially problematic for symptoms for
which there are no diagnostic tests. A person can tell you that he or
she has a headache, is tired, or just doesn't feel very well, but a rat
or mouse can not; by definition, such symptoms only can be seen in
human studies. Therefore, the Gulf War committees have relied more on
human studies, including epidemiologic and clinical studies, to reach
conclusions regarding the association between an exposure to an agent
and a health outcome. Animal data, when available, provide support for
those conclusions.
Next I would like to briefly discuss what we know about the
exposures in the Gulf War, and how that has affected the work of
committees. The legislation that led to the Gulf War and Health studies
lists a number of chemical and biological agents that the IOM was asked
to consider. The number and diversity of those agents precluded all of
the agents being reviewed by a single Committee in a single report. The
IOM held an open meeting with veterans and veteran service
organizations to help identify the agents the veterans were most
concerned about. On the basis of that meeting, the agents were
prioritized for review.
All of the Gulf War committees have grappled with the issue of
exposure and the lack of information, not only on how much of a
chemical a person was exposed to, but even the specific chemicals a
person might have been exposed to. For example, the committee could not
find any information on which vaccines or medications, or the amount of
a medication, that a specific person took during deployment. The
committee members heard from veterans about being given a vaccination,
for example en route to the combat arena, but they did not know what
the vaccination was for, and the Committee was told by the DoD that
there are no records of who received what vaccinations. In other cases,
when asked, veterans reported being exposed to a multitude of agents
such as pesticides, pyridostigmine bromide, kerosene heaters, and oil
well fire smoke during their deployment, but the levels of exposure to
specific agents have not been determined and possibly never will be.
This lack of information on exposure makes it very difficult to link a
given health effect in veterans to a specific exposure.
Although most of the Gulf War committees looked at the health
effects of the potential exposures, one of the committees was charged,
as directed by the attached legislation, with evaluating Gulf War
veterans' health. This Committee reviewed the published studies
conducted on the Gulf War veterans themselves and made conclusions on
the prevalence of health outcomes in the veterans. Because of the lack
of exposure information, however, that report does not link health
outcomes to specific exposures. An updated review of the literature on
Gulf War veterans published since the preparation of that report is
currently underway.
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 Oversight and Investigations of the House Committee on
Veterans' Affairs. On behalf of all IOM Gulf War committee members past
and present I thank you for your trust in our ability to assist you
with this important work for our Nation's veterans. I know from my
service on these committees that the Nation's scientists are happy to
serve, and look to you for guidance on how we can be of most assistance
to you and the VA in assessing health impacts of Gulf War deployment. I
look forward to answering any questions you might have.
Prepared Statement of James H. Binns, Chairman,
Research Advisory Committee on Gulf War Veterans' Illnesses
Chairman Mitchell, Ranking Member Roe, Members of the Committee,
the Research Advisory Committee on Gulf War Veterans Illnesses is a
public advisory body of scientists and veterans mandated by Congress
and appointed by the Secretary of Veterans Affairs. The Committee's
statutory mission is to review research studies and plans related to
the illnesses suffered by veterans of the 1991 Gulf War.
In a moment you will hear from Dr. Steele how the Committee's
approach to reviewing the science has differed from that used in the
Institute of Medicine reports. I will discuss the legal background of
the reports.
It is important to understand is that neither the Research Advisory
Committee report, nor the IOM Gulf War reports, are original scientific
research. They are intended to be summaries of what others have found.
The reason the IOM is involved in this subject is because, in the
same law that established the Research Advisory Committee, Congress
directed VA to contract with the IOM to prepare reports to guide the
Secretary of Veterans Affairs in determining Gulf War veterans'
benefits. Congress was very specific about how it wanted these reports
done.
Congress directed VA to have IOM review the scientific literature
for thirty-three hazardous substances to which troops were exposed in
the war to see if any of those substances have been associated with an
increased risk of illness. If there was sufficient evidence of such an
association, the Secretary was directed to prescribe a presumption of
service connection for Gulf War veterans' health and disability
benefits. Because most studies of hazardous substances are done in
animals, the law required that both human and animal studies be
considered. Because veterans were often exposed to combinations of
substances, the law required that the reports should consider
combinations of exposures. And because Gulf War veterans' illnesses
often do not fit conventional diagnoses, the law required that
undiagnosed illnesses should also be considered.
Yet, as the IOM reports themselves state, only evidence from human
studies was considered, combinations of exposures were not considered,
and undiagnosed illnesses were not considered. The result is that the
committees of scientists who worked on the IOM reports were attempting
to put together a puzzle that was missing half the pieces.
Virtually all of these scientists, who are volunteers who spend
most of their time reviewing the literature that IOM staff sends them,
had no idea they were not following the law, I'm sure. They were
undoubtedly told that they were following standard IOM methodology. The
Gulf War reports state that the methodology comes from earlier IOM
reports ordered by Congress related to Agent Orange exposure in
Vietnam. As a Vietnam veteran, I well remember that for twenty years
after that war, the government denied there was any connection between
Agent Orange and the health problems of Vietnam veterans until Congress
ordered the IOM to do this kind of report.
However, a close examination shows that the Agent Orange
methodology was subtly changed in the Gulf War reports. One word, the
word ``human,'' was inserted in the definition of whether there is
sufficient evidence that a substance is associated with an increased
risk of illness. That definition determines the conclusion of the
report. It is what the Secretary is directed to rely upon in deciding
if there should be a presumption of service connection for veterans'
benefits. The effect of this change is that animal studies were not
considered in the conclusion of the reports, even though the law
specifically required them to be considered in the conclusion by both
the IOM and the Secretary. Whether they were considered elsewhere is of
no consequence.
In short, the IOM Gulf War reports do not follow the requirements
of the law that ordered them, nor do they follow the established
methodology of the IOM itself. As a result, there have been no
significant presumptions of service connection made on the basis of the
IOM reports.
As to how this could have occurred, I would refer you to my written
testimony, which includes correspondence between VA and IOM staff prior
to the start of one of the reports. The documents show that discussions
between VA and IOM staff led to an agreement that placed conditions on
the report that predetermined its outcome before the IOM committee to
prepare it was ever appointed.
Today I am pleased to report that the VA official involved in those
discussions has recently left the VA. I am also encouraged that the new
Secretary of Veterans Affairs is manifestly committed to transforming
the culture at VA headquarters to better serve veterans. So I hope that
change is on the way and look forward to the testimony of the
Department of Veterans Affairs this morning.
Change is sorely needed. I have worked for three previous
Secretaries of Veterans Affairs, who were all honorable men, but have
sadly seen VA staff continue to minimize the serious health problems of
Gulf War veterans, including the misuse of the Institute of Medicine.
Benefits continue to be denied. And because of the stature of the IOM,
its reports have misled researchers, physicians, Congress, veterans'
families and veterans themselves. In December, VA ordered a new IOM
report to review the report of the Research Advisory Committee, rather
than act on its recommendations. IOM has a Committee working on this
new report, although IOM says it will not review the RAC report.
What is clear is that the VA/IOM relationship is in urgent need of
reform. I am distressed that these two great institutions cannot
candidly acknowledge these problems and address them. The Institute of
Medicine is the high court of American medical science. Manipulation of
its processes by the government is a serious breech of public trust
with implications far beyond this topic.
In view of the gravity of these issues, I will describe them in
detail and provide the original documents to the Subcommittee staff
showing precisely what has occurred. Page references are to the
document package provided to staff.
Has VA complied with the statute requiring the IOM reports, and has
the IOM followed the statute and its own established methodology?
In the same 1998 laws that established the Research Advisory
Committee, PL 105-277 and PL 105-368, Congress directed the Department
of Veterans Affairs to contract with the National Academy of Sciences
(NAS, the parent organization of the Institute of Medicine), to review
the scientific literature regarding 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 the illness should
be presumed service-connected for the purpose of veterans' benefits.
The law directed the NAS to identify the ``biological, chemical, or
other toxic agents, environmental or wartime hazards, or preventive
medicines or vaccines'' to which members of the Armed Forces may have
been exposed during the war. 38 USC Sec. 1117, note Sec. 1603 (c).
[documents p. 2] The law listed thirty-three specific ``toxic agents,
environmental or wartime hazards, or preventive medicines or vaccines
associated with Gulf War service'' to be considered, including various
pesticides; pyridostigmine bromide, a drug used as a nerve agent
prophylaxis; low-level nerve agents; other chemicals, metals, sources
of radiation; and infectious diseases. 38 USC Sec. 1117, note Sec. 1603
(a), (d). [documents, pp. 3-4] The law further required the NAS to
identify illnesses, ``including diagnosed illnesses and undiagnosed
illnesses,'' experienced by Armed Forces members who served in the war.
38 USC Sec. 1117, note Sec. 1603 (c) [documents, p. 4]
``For each agent, hazard, or medicine or vaccine and illness
identified,'' the law provided that:
``The National Academy of Sciences shall determine . . .
(A) whether a statistical association exists between exposure
to the agent . . . and the illness . . .
(B) the increased risk of the illness among human or animal
populations exposed to the agent . . . and
(C) whether a plausible biological mechanism or other evidence
of a causal relationship exists . . .''
38 USC Sec. 1117, note Sec. 1603 (e) [documents, p. 4, emphasis
added]
The statute went on to provide that the Secretary of Veterans
Affairs should consider both human and 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.''
38 USC Sec. 1118 (b)(1)(B) [documents, p. 9, emphasis added]
Congress thus expressly required consideration of animal as well as
human studies by both the National Academy of Sciences (the Institute
of Medicine) and the Secretary of Veterans Affairs. This statutory
requirement reflects the fact that most studies on the biological
effects of hazardous substances are done in animals, for ethical
reasons. Consider, for example, the twenty-three studies on the long-
term effects of low level sarin exposure, or the eighteen studies
evaluating the combined effects of pyridostigmine bromide, pesticides
and insect repellant listed on pages 160-161 and 170-171 of the
Research Advisory Committee report, all of which were done in animals.
When the first IOM report was conducted under the law, however,
animal studies were omitted from the standard for determining whether
an association exists between an exposure and a health effect. The
report states:
``For its evaluation and categorization of the degree of
association between each exposure and a human health effect, however,
the [IOM] Committee only used evidence from human studies.''
Gulf War and Health, Volume 1, p. 72 [documents, p. 11]
Considering only human studies and not the substantial relevant
literature on animal studies, and disregarding other statutory
requirements described below, the IOM Committee rarely found sufficient
evidence of an association for the exposures considered, and none
directly applicable to the exposures and illnesses experienced by Gulf
War veterans. Following the guidance of the IOM, the Secretary of
Veterans Affairs made no determinations of service-connection for
veterans' benefits. This pattern has been followed in all IOM Gulf War
reports to date.
The failure to consider animal studies contravened clear and
repeated statutory requirements. IOM's Gulf War reports have also been
deficient with respect to other statutory requirements, as described in
the Research Advisory Committee report at pages 54-55. The IOM reports
were required by law to consider not only diagnosed illnesses but also
undiagnosed illnesses, but they have not. The second IOM Gulf War
report, for example, acknowledged that the IOM Committee was not
charged with addressing ``nonspecific illnesses that lack defined
diagnoses . . .'' Gulf War and Health Volume 2, p. 13. [documents, p.
12] As a result, IOM Committees have preoccupied themselves with
diagnosed illnesses that have not be found to date in elevated rates in
Gulf War veterans, while ignoring the multisymptom condition known as
``Gulf War illness'' that afflicts one in four.
The law also defines toxic agents to include combinations of
exposures (``whether through exposure singularly or in combination.'')
38 USC Sec. 1117, note Sec. 1605(1) [documents, p. 8] The Research
Advisory Committee report lists several pages of scientific studies
that have been done on combinations of agents to which veterans were
exposed in the Gulf War. [Report, pp. 168, 170-171, 175] Yet, the
second IOM report also acknowledged that ``exposure to multiple
agents'' was not within the Committee's charge. Gulf War and Health
Volume 2, p. 13 [documents, p. 14]
These findings alone would be sufficient to require that the
erroneous IOM Gulf War reports to date be redone in accordance with the
law, as recommended by the Research Advisory Committee report at page
57.
However, a close examination of what occurred makes clear that the
problem is worse and that the exclusion of animal studies cannot have
been an oversight. It was deliberate.
To express conclusions as to whether an association between an
exposure and an illness exists, the first IOM Gulf report defined five
``Categories of Association.'' Gulf War and Health, Vol. 1, pp. 83-84.
[documents, p. 13-14] The same categories have been used in all
subsequent IOM Gulf War exposure reports:
Sufficient Evidence of a Causal Relationship
Sufficient Evidence of an Association
Limited/Suggestive Evidence of an Association
Inadequate/Insufficient Evidence to Determine Whether
an Association Does or Does Not Exist
Limited/Suggestive Evidence of No Association.
Each substance was ranked according to these categories. How a
substance is ranked becomes the all-important conclusion of the report
as to whether an association exists between an exposure and illness.
Where did these categories come from? The report explained: ``The
Committee used the established categories of association from previous
IOM studies, because they have gained wide acceptance for more than a
decade by Congress, government agencies, researchers, and veteran
groups.'' Gulf War and Health, Volume 1, p. 83. [documents, p. 15]
``The categories closely resemble those used by several IOM Committees
that evaluated . . . herbicides used in Vietnam . . . '' Gulf War and
Health, Volume I, p. 83. [documents, p. 15]
IOM Gulf War reports have repeatedly stressed over the years that
their methodology is based on the IOM Agent Orange reports. However, it
is revealing to compare a category of association used in the Agent
Orange reports with the same category used in the Gulf War reports.
Agent Orange:
``Sufficient Evidence of an Association. 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 . . .
''
Veterans and Agent Orange: 1996 Update, p. 97 [documents, p. 15,
emphasis added]
Gulf War:
``Sufficient Evidence of an Association. 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 . . .''
Gulf War and Health: Volume I, p. 83 [documents, p. 13, emphasis
added]
The Gulf War category does indeed ``closely resemble'' the Agent
Orange category--with a conspicuous exception. The word ``human'' has
been inserted in the Gulf War category.
This addition obviously did not occur by accident. It was
deliberate, as was the misleading language that these were the
``established categories of association from previous IOM reports.''
Thus, not only have the IOM Gulf War studies been conducted in
violation of the direction Congress provided in the statute; this
violation has been deliberate, with intent to conceal.
As to why it was done, one can speculate based on the knowledge
that the Agent Orange language, just a few years earlier, had produced
an IOM report that found that Agent Orange exposure was associated with
cancer (after two decades of government denial of any health
consequence). This finding led to a presumption of service connection
for thousands of Vietnam veterans with cancer.
It should be noted that the IOM Gulf War reports state that animal
studies were considered for purposes of ``biological plausibility'':
``For its evaluation and categorization of the degree of association
between each exposure and a human health effect, . . . the Committee
only used evidence from human studies. Nevertheless, the Committee did
use nonhuman studies as the basis for judgments about biological
plausibility, which is one of the criteria for establishing
causation.'' Gulf War and Health, Volume 1, p. 72 [documents, p. 16]
The terms of the Gulf War categories of association make clear,
however, that biological plausibility and causation only relate to the
highest category of evidence, ``sufficient evidence of a causal
relationship,'' and are not considered unless there has been a previous
finding of ``sufficient evidence of association'':
``Sufficient Evidence of a Causal Relationship. Evidence is
sufficient to conclude that a causal relationship exists between the
exposure to a specific agent and a health outcome in humans. The
evidence fills the criteria for sufficient evidence of association
(below) and satisfies several of the criteria used to assess causality:
strength of association, dose-response relationship, consistency of
association, temporal relationship, specificity of association, and
biological plausibility.
Sufficient Evidence of an Association. 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 with reasonable confidence.'' Gulf War
and Health, Volume 1, p. 83. [documents, p. 13, emphasis added]
Thus, only if there has already been a finding of ``sufficient
evidence of association'' do the issues of causality and biological
plausibility arise, and a finding of ``sufficient evidence of
association'' depends solely on human studies. Unless an association is
found based on human studies, biological plausibility--and animal
studies--are not considered.
It is notable that the statute does not require evidence of a
``casual relationship'' to trigger a presumption of service connection.
It only requires evidence of a ``positive association'':
``[T]he Secretary shall prescribe regulations providing that a
presumption of service connection is warranted [if the Secretary makes
a] determination based on sound medical and scientific evidence that a
positive association exists between--
(i) the exposure of humans or animals to a
biological, chemical, or other toxic agent,
environmental or wartime hazard, or preventive medicine
or vaccine known or presumed to be associated with
service in the Southwest Asia theater of operations
during the Persian Gulf War; and
(ii) the occurrence of a diagnosed or undiagnosed
illness in humans or animals.''
38 USC Sec. 1118 (b)(1) [emphasis added, documents pp. 8-9]
In short, in direct contravention of the statute, the methodology
established for the IOM Gulf War reports deliberately excluded animal
studies from consideration as to whether an association exists between
an exposure and an illness, the only question that matters in the
determination of benefits.
As to how this was done, the history of one of the IOM Gulf War
reports provides an indication. The 2004 IOM Updated Literature Review
of Sarin is the most egregious example of the distortion of science
produced by excluding animal studies from the evidence considered in
report conclusions. In late 2002, a number of new studies on sarin
nerve gas, sponsored by the Department of Defense, revealed that
contrary to previous belief, low level exposures (below the level
required to produce symptoms at the time of exposure) produced long-
term effects on the nervous and immune systems. Naturally, these
studies were done in animals.
A previous IOM report on sarin in 2000 had found insufficient
evidence of an association between low-level sarin and long-term health
effects based on scientific knowledge as of that date. On January 24,
2003, 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 this new research affects earlier conclusions of IOM . . .
about possible long-term health consequences of exposure to low levels
of Sarin.'' [documents, p. 17]
In 2004, the IOM delivered its report. The Updated Literature
Review of Sarin discussed the new animal studies in its text. However,
true to form, the report did not consider animal studies in the all-
important categories of association, even though the new animal studies
were the only reason for doing the report.``
``As with previous Committees, this Committee used animal data for
making assessments of biological plausibility . . . rather than as part
of the weight of evidence to determine the likelihood that an exposure
to a specific agent might cause a long-term outcome.'' Updated
Literature Review of Sarin (2004), p. 20 [documents, p. 18] Accordingly
it found insufficient evidence of an association.
To understand how such a bizarre outcome was even possible, it is
necessary to understand the process through which IOM reports are
prepared. After the IOM is requested to do a report, a proposal is
prepared by the IOM which becomes the basis for a contract between the
IOM and the requesting organization (in this case VA). Then IOM staff
recruit a Committee of scientists to carry out the assignment. As
described by an IOM staff Member, she looks for scientists with
expertise in fields relevant to the subject of the report, but who have
no particular knowledge of that subject. IOM staff then staffs the
preparation of the report by the Committee.
The proposal for the sarin update was sent to VA on March 11, 2003,
with a cover letter from Susanne Stoiber, executive director of the
IOM, to Dr. Mark Brown, director of the VA Environmental Agents
Service. The cover letter stated: ``This proposal follows a request
from Secretary Anthony J. Principi and discussions with yourself
requesting an update of the health effects of the chemical warfare
agent sarin.'' [documents, p. 19]
The proposal contained the following ``Statement of Task'':
[documents, p. 22]
``The Committee will conduct a review of the peer-reviewed
literature published since earlier IOM reports on health effects
associated with exposure to sarin and related compounds. Relevant
epidemiologic studies will be considered. With regard to the
toxicological literature, the Committee will generally use review
articles to present a broad overview of the toxicology of sarin and to
make assessments of biologic plausibility regarding the compound of
study and health effects; individual toxicology research papers will be
evaluated as warranted.
The Committee will make determinations on the strength of the
evidence for associations between sarin and human health effects. If
published peer-reviewed information is available on the dose of sarin
exposure in Gulf War veterans, the Committee may address the potential
health risks posed to the veterans . . .''
In other words, the Statement of Task established that the update
report would use the same ``categories of association'' as the earlier
Gulf War reports. The ``determinations on the strength of the
evidence'' would be made on the basis of the ``associations between
sarin and human health effects.'' ``With regard to the toxicological
literature'' (which included the new animal studies), its use would be
confined to the assessment of ``biological plausibility'' to which
animal studies had previously been relegated. Thus, the update report
would exclude animal studies from its key conclusions, even though
animal studies were the only reason for doing the report.
Moreover, the Statement of Task set up another fundamental
constraint for the report. The IOM Committee would be permitted to
address the potential health risks posed to the veterans ``[i]f
published peer-reviewed information is available on the dose of sarin
exposure in Gulf War veterans.'' As anyone familiar with Gulf War
research would know, including Dr. Brown and his IOM counterparts,
there is no published peer-reviewed information available on the dose
of sarin exposure in Gulf War veterans, for the reason that no such
information was collected during the war. As noted in the previous 2000
IOM report on sarin, ``as discussed throughout this report, there is a
paucity of data regarding the actual agents and doses to which
individual veterans were exposed.'' Gulf War and Health, Volume 1, p.
84. [documents, p. 14] In order for the IOM Committee to address the
health risks posed to veterans, it had to meet a condition that was
impossible to meet.
These constraints in the Statement of Task were not contained in
the letter from Secretary Principi requesting the report. (To the
contrary, they appear to contradict it.) Thus, they must have come from
the ``conversations with yourself'' referred to in Ms. Stoiber's letter
to Dr. Brown.
Thus, conversations between Dr. Brown and IOM staff determined the
outcome of the report before the IOM Committee to prepare the report
was ever appointed.
In conclusion, VA staff has not complied with the law requiring the
IOM Gulf War reports, and IOM has not followed the law or its own
established methodology, restricting the scientific evidence required
to be considered. This action has been deliberate. Conversations
between VA and IOM staff have shaped the methodology of the reports so
as to predetermine their outcome.
The practices described in this testimony demonstrate that the
relationship between VA and the IOM should be thoroughly investigated
and reformed at both the government and Institute ends. Past IOM Gulf
War reports should then be re-done in accordance with the law, as
recommended by the Research Advisory Committee report. Alternatively,
VA should make a determination of a presumption of service connection
on the basis of the scientific evidence contained in the 2008 Research
Advisory Committee report and the large VA study published in April
2009, ``Health of U.S. Veterans 1991 Gulf War: A Follow-up Survey in 10
Years,'' which shows that multisymptom illness is the most prevalent
health problem of Gulf War veterans, afflicting one in four.
Prepared Statement of Lea Steele, Ph.D., Adjunct
Associate Professor, Kansas State University School of
Human Ecology, Manhattan, KS, and Former Scientific Director,
Research Advisory Committee on Gulf War Veterans' Illnesses
Good morning Mr. Chairman and Members of the Subcommittee. I'm Dr.
Lea Steele. I've been asked to testify this morning on why and how
scientific findings of the Institute of Medicine (IOM)'s Gulf War and
Health reports differ from those of the Research Advisory Committee on
Gulf War Veterans' Illnesses. As you may recall from my appearance
before the Subcommittee last May, I am an epidemiologist, and first
conducted research on the health of Gulf War veterans for the State of
Kansas in 1997. More recently, I preceded Dr. White as Scientific
Director of the Congressionally mandated Research Advisory Committee on
Gulf War Veterans' Illnesses, or RAC. In that position, I had primary
responsibility for overseeing the RAC's review of research and
preparation of a comprehensive report, Gulf War Illness and the Health
of Gulf War Veterans, released in November, 2008.
Issues surrounding health problems affecting veterans of the 1991
Gulf War are exceedingly complex. An enormous amount of research
studies and government investigations have been done to determine what
happened during the Gulf War and why so many veterans developed Gulf
War illness. This is the term most often used for the pattern of
symptoms consistently found at high rates in Gulf War veterans, but not
explained by established medical or psychiatric diagnoses. The 2008 RAC
report provided a detailed review and synthesis of evidence provided by
nearly 2,000 scientific studies and government reports and documents.
The report concluded that this evidence clearly indicates that Gulf War
illness is real and continues to be widespread, affecting at least one
in four of the nearly 700,000 U.S. veterans of the 1991 Gulf War.
Further, multiple sources of evidence point most consistently to two
primary causes: (1) the small white pyridostigmine bromide pills, or
PB, given to protect troops from the deadly effects of nerve agents,
and widely used only in the 1991 Gulf War, and (2) pesticides, used
excessively during the 1991 Gulf War to protect troops from disease-
causing insects in the region. Both PB and some pesticides overused in
the Gulf War affect the brain and nervous system by altering levels of
an essential nerve signaling chemical, the neurotransmitter
acetylcholine. The evidence from multiple studies also consistently
shows that Gulf War illness was not caused by serving in combat or
psychological stress and that posttraumatic stress disorder (PTSD)
affects relatively few veterans of the brief 1991 Gulf War, compared to
veterans of other conflicts.
Many of the 2008 RAC Report's major conclusions differ
fundamentally from those of the IOM's Gulf War and Health reports. The
IOM reports were prepared under contract with the Department of
Veterans Affairs (VA) in response to a Congressional directive. As
described by Mr. Binns, VA was directed to commission IOM to perform a
comprehensive scientific review to determine what the evidence showed
about health problems affecting Gulf War veterans and their
associations with exposures during the Gulf War. As part of the RAC's
work, we reviewed all the IOM Gulf War and Health reports. Our
Committee was sufficiently troubled by how IOM reviewed the evidence on
Gulf War health issues that our report details a number of far-ranging
problems, raising fundamental questions about both the process used by
IOM and their resulting findings. We recommended that the IOM reports
be redone to adhere to the requirements set forth by Congress.
I want to be clear that Members of the RAC have great respect for
the IOM, generally, and were not anxious to criticize IOM's Gulf War
reports. Our Committee includes an honored Member of the National
Academy of Sciences and the Institute of Medicine, and several
scientists who have served on IOM panels over the years. We felt it
necessary to raise these concerns, however, because of the wide
expectation that the IOM reports would provide definitive information
on the health of Gulf War veterans, and because of the complexity and
importance of Gulf War health issues. VA relies on the IOM Gulf War and
Health reports to assist the Secretary in making decisions about
veterans' disability compensation. And, as you heard at last May's
Subcommittee hearing on Gulf War illness, both VA and Department of
Defense (DoD) officials cite these reports as being authoritative. We
did not take lightly our decision to raise such serious questions about
the IOM Gulf War reports, but believed there was an obligation to do
so.
Table 1. Types of Evidence Used to Establish Findings on the Health of
Gulf War Veterans: Research Considered in IOM Gulf War Reports and the
2008 RAC Report
Was This Type of Evidence
Considered in Report Findings?
Categories of Research IOM Gulf War and
EvidenceRelevant to the Health of Health Reports 2008 RAC Report
Gulf War Veterans
Results of Peer-reviewed and
Published Scientific Studies
Studies of Gulf War veterans
1. Studies that assessed prevalence YES YES
of diagnosed medical and
psychiatric conditions in Gulf War
veterans.
2. Studies that assessed prevalence (Limited) YES
of undiagnosed multisymptom illness
in Gulf War veterans. 3. Studies that assessed (Limited) YES
associations between Gulf War
exposures and diagnosed conditions
in Gulf War veterans.
4. Studies that assessed No YES
associations between Gulf War
exposures and undiagnosed
multisymptom illness in Gulf War
veterans. Studies of chemical exposures in
other human populations 5. Studies that assessed YES YES
association of exposures with
diagnosed diseases.
6. Studies that assessed No YES
association of exposures with
undiagnosed symptomatic illness. Studies of effects of chemical
exposures in animal models 7. Studies of biological and No YES
behavioral effects of exposures in
animals. 8. Studies of effects of No YES
combinations of exposures.Results of Other Federally-sponsored
Gulf War Scientific Studies 9. Findings provided in project No YES
reports from DoD-funded studies.
10. Findings presented at scientific No YES
conferences, RAC meetings.Investigations, Reports on Exposures
During the Gulf War11. Reports from Federal agencies No YES
(e.g. DoD, CIA) that documented or
modeled types, levels, and patterns
of Gulf War exposures (e.g.
pesticides, oil fire smoke, nerve
agents, depleted uranium).
12. Reports from nongovernmental No YES
sources (e.g. RAND, Battelle) that
investigated and/or modeled Gulf
War exposures.
So, why are the IOM reports' findings so different from those of
the RAC Report? There are two overarching reasons: (1) the primary
questions addressed by the IOM and RAC reports differed fundamentally,
and (2) the RAC considered a much broader scope of evidence to arrive
at its findings. The differences between the RAC and IOM reports are
not subtle, and are not explained by minor variations in the review
methods used or how individual study results were interpreted or
weighed. Rather, they are the result of major differences in the scope
of questions addressed by the two reports, and the scope of the
evidence used to answer those questions.
There are many sources and types of research that provide credible
information on the health of Gulf War veterans and exposures during the
Gulf War. Twelve general categories of research that directly relate to
Congress's directives for the IOM Gulf War reports are listed in Table
1. Each category includes multiple individual investigations--sometimes
hundreds of studies. All categories of evidence in the table were found
to be informative and useful by the RAC, and were considered, in
detail, to arrive at the findings and recommendations in the 2008 RAC
report. IOM's Gulf War and Health reports relied, in large part, on
just two categories of evidence: (1) studies that assessed rates of
diagnosed medical and psychiatric conditions in Gulf War veterans, and
(5) studies that assessed diagnosed diseases in other human populations
exposed to chemicals. Most of the hundreds of findings in the IOM Gulf
War and Health reports were based exclusively on studies of diagnosed
diseases in these other populations, for example studies of a type of
cancer in workers exposed to a specific chemical in the workplace.
Although this was a detailed effort, the long list of IOM findings
almost all pertain to diagnosed diseases that have never been
associated with service in the Gulf War. A very limited number of the
IOM's findings relate specifically to health problems found in Gulf War
veterans.
Major categories of evidence were not considered by IOM, or were
considered only in a very limited way. As described by Mr. Binns, the
many animal studies conducted to identify biological and behavioral
effects of Gulf War exposures and combinations of exposures were not
considered by IOM in assessing levels of evidence. IOM findings also
made little use of the hundreds of government investigations on types
and patterns of exposures during the Gulf War, which provided important
insights in a broad range of areas. These include modeled estimates of
low-level exposures to nerve agents in theater, detailed investigations
into PB use among Gulf War veterans, and in-depth reports on the types
and patterns of use of over 60 different pesticide products, which
indicated that thousands of troops were overexposed during deployment.
In addition, the hundreds of detailed Gulf War epidemiologic findings
on associations between Gulf War illness and Gulf War exposures were
scarcely considered by IOM.
Limitations in the evidence considered had profound effects on the
IOM Gulf War and Health reports and underlie the major differences
between RAC's findings and IOM's findings. There are numerous examples
of specific differences, many of which are somewhat technical to
describe. One straightforward example relates to the magnitude of the
Gulf War illness problem. Both the IOM and the RAC reports indicate
that all studies consistently identify significantly excess rates of
symptoms and multisymptom illness in Gulf War veterans. But the IOM and
RAC provide very different figures for how many veterans have been
affected. Seven studies have provided estimates of the excess rate of
multisymptom illness in Gulf War veterans, when compared to era
veterans who did not deploy to the Persian Gulf theater. Six of the
studies were published prior to both the IOM and the RAC Gulf War
reports; findings from the seventh study were provided to the RAC prior
to publication.
As shown in Table 2, six of the seven studies found that 25-32
percent of Gulf War veterans were affected by a defined pattern of
multisymptom illness, in excess of background symptom levels affecting
nondeployed era veterans. One study reported about half that rate, 13
percent. The RAC report presented results from all seven studies. Based
on the consistency of the excess rate of illness in 6 of 7 studies, and
other supporting indicators, the RAC found that between 25 and 32
percent of veterans were affected by multisymptom illness, in relation
to service in the Gulf War. In contrast, the IOM report relied on a
single estimate from just one study, the 13 percent estimate. Overall,
different Gulf War studies have different strengths and weaknesses. But
the single study on which IOM relied was not superior to the other
studies, and had some important limitations. We know that a more recent
and larger study from the same veteran population found an excess rate
of 25 percent of Gulf War veterans with multisymptom illness. So it is
unclear why the IOM finding on prevalence relied on a single study
indicating an excess prevalence of 13 percent, when all other studies
consistently found the rate to be about twice as high.
Table 2. Excess Prevalence of Multisymptom Illness in Gulf War Veterans, Compared to Nondeployed Veterans:
Studies Considered in IOM Gulf War Reports and the 2008 RAC Report
----------------------------------------------------------------------------------------------------------------
Was This Finding Included in
----------------------------------------------------------------------------- Report?
Excess -----------------------------------
Number of Prevalence
Veteran Group Studied Study Gulf War in Gulf War IOM Gulf War and 2008 RAC Report
Veterans Veterans Health Reports
----------------------------------------------------------------------------------------------------------------
U.S. Air Force veterans Fukuda,1998 1,155 30% No YES
----------------------------------------------------------------------------------------------------------------
U.K. male veterans Unwin, 1999 4,428 26% No YES
----------------------------------------------------------------------------------------------------------------
Kansas veterans Steele, 2000 1,548 26% No YES
----------------------------------------------------------------------------------------------------------------
New England Army veterans Proctor, 2001 180 32% No YES
----------------------------------------------------------------------------------------------------------------
U.K. female veterans Unwin,2002 226 29% No YES
----------------------------------------------------------------------------------------------------------------
U.S. national study, Phase III Blanchard, 2006 1,035 13% YES YES
----------------------------------------------------------------------------------------------------------------
U.S. national longitudinal Kang, 2007 5,767 25% No YES
study
----------------------------------------------------------------------------------------------------------------
Another example of differences between the two Committee reports
relates to a highly publicized finding from IOM that there is no
``unique'' Gulf War illness. This finding has been widely
misinterpreted to indicate that there is no Gulf War illness problem at
all. The RAC report examined this issue in depth. It determined that
Gulf War illness is a real and definable problem, based on the
consistency of the types and patterns of excess symptoms identified in
studies of Gulf War veterans from different units, regions of the U.S.,
and Coalition countries. It also considered different interpretations
of the question of how a syndrome might be considered ``unique.'' We
concluded that the ``unique syndrome'' question has been rather
meaningless since it can be answered in a variety of ways, depending on
how it is construed. In contrast, the IOM report's finding that there
is no ``unique syndrome'' was based on the failure of a type of
statistical approach to identify a ``unique syndrome.'' Unfortunately,
the IOM report did not evaluate the scientific merit of that approach,
or expert opinion and research indicating that, as applied in Gulf War
studies, the method is incapable of identifying a ``unique syndrome.''
Returning to the big picture, what are the actual implications of
the differences between the RAC and IOM Gulf War reports? Are they
really important? The IOM Gulf War and Health reports were intended by
Congress to evaluate the evidence on diagnosed and undiagnosed health
problems in Gulf War veterans, and their association with exposures
during the Gulf War. At the end of the day, after government officials
and others have read the IOM reports, they will know very little about
the ``undiagnosed,'' but widespread problem of Gulf War illness--its
characteristics, its impact on veterans, and its causes. They will not
know that this symptom complex is consistently described in study after
study of Gulf War veterans. They will not know about the large number
of veterans affected, or that few have recovered over time. They will
not know what an extensive number of studies tells us about
associations of this illness with combat stress and with exposures
during the Gulf War. And they will not know if these findings are
consistent with results of animal studies, research in other human
populations, or what we know from government investigations about
exposures during the Gulf War. This is not because the RAC and IOM
reviewed the same studies, but arrived at different scientific
conclusions about what the evidence tells us. It is because the IOM
reports and findings, fundamentally, do not address these issues or
take into account the broad types of research available to address
them.
The health problems affecting veterans of the 1991 Gulf War have
presented difficult and complex challenges for veterans who are ill,
and also for scientists and health care providers striving to better
understand these problems. In the years since the Gulf War it has
become clear that selective or simplistic consideration of the research
evidence related to Gulf War illness yields few answers. Meaningful
progress requires that these complex problems be engaged in a complex
way, and that all available pieces of the puzzle be considered.
Progress in addressing Gulf War illness remains urgently important,
with thousands of ill veterans still waiting for clear answers and
beneficial treatments more than 18 years after Desert Storm.
Prepared Statement of Robert W. Haley, M.D., FACE, FACP,
Professor of Internal Medicine-Epidemiology, Department of
Internal Medicine, University of Texas Southwestern Medical
Center at Dallas, TX
Good morning, Mr. Chairman and distinguished Members of the
Subcommittee. I want to thank you for inviting me to describe our
research program on Gulf War illness at the University of Texas
Southwestern Medical Center in Dallas and our collaborating
universities and research organizations across the country. To
introduce myself briefly, after training in Internal Medicine, I served
for 10 years at the U.S. Centers for Disease Control and Prevention
(CDC) where I received a U.S. Public Health Service commendation medal
for my research on controlling hospital-acquired infections. Since 1983
I have been on the faculty of the University of Texas Southwestern,
doing clinical research, teaching research design to our young
assistant professors, and supervising an Internal Medicine service at
Parkland Hospital. During my first 10 years on the faculty, I
volunteered as an attending physician at the Dallas VA Medical Center.
Initial Studies, 1994-1998
In 1994, 3 years after the first Gulf War, Ross Perot visited with
our university president and me, as Director of Epidemiology. He
acquainted us with the newly emerging problem of Gulf War syndrome, and
asked if UT Southwestern would undertake a study of the problem with
funding from the Perot Foundation. I put together a small research team
and performed an epidemiologic survey and follow-up clinical study of
the 24th Reserve Naval Construction Battalion (Seabees) that had served
in the Gulf War. While the research world at the time was focused
almost exclusively on stress and psychological explanations, our
studies pointed clearly toward a physical illness. Our findings raised
the following three provisional hypotheses to be explored in further
research:
1. The Gulf War syndrome appeared to be a real physical brain
illness--a chronic encephalopathy--with 3 subtypes, or
variants.
2. The many symptoms appeared to be due to damage to cells in
different deep brain structures.
3. The damage appeared to be caused by wartime exposure to
combinations of neurotoxic chemicals, including low-level
sarin, organophosphate (OP) pesticides and the pyridostigmine
bromide (PB) anti-nerve agent medication.
These initial findings were published in January 1997 in three high
profile peer-reviewed articles in the prestigious Journal of the
American Medical Association.
The media reaction from that publication introduced me to several
young Gulf War veterans dying of Lou Gehrig's disease (amyotrophic
lateral sclerosis, or ALS). My subsequent investigation documented a
statistically significant threefold increase in the rate of ALS in
atypically young Gulf War veterans. When this was subsequently verified
by a VA study, it led to service connection for all military veterans
with ALS.
Second Round of Studies, 1998-2001
With leadership and staunch support from Texas Senator Kay Bailey
Hutchison, the Department of Defense provided substantial research
funding to follow up our findings. We began to explore new medical
technologies that would probe directly for the nature and mechanisms of
the hypothesized brain cell damage to give doctors a rational basis for
diagnosing and treating it and give VA objective tests for determining
service connection in these veterans. Here is a summary of the main
findings from this work, which spanned 1998 to 2001 and was described
in prominent peer-reviewed scientific publications.
1. Chemical Evidence of Brain Cell Damage. We performed brain
scanning with an MRI-based technique called Magnetic Resonance
Spectroscopy (MRS), which measures chemical concentrations in
small brain regions of living subjects. We found evidence of
chemical alterations in the deep brain structures of ill Gulf
War veterans compared to well veterans. This type of chemical
change is characteristic of physical brain cell damage and is
not found in stress and psychological reactions. The group of
veterans with the syndrome 2 variant (``confusion-ataxia'') had
evidence of more severe brain cell damage than the syndrome 1
(``impaired cognition'') and 3 (``central pain'') variants.
2. Abnormal Production of Brain Dopamine. We performed
chemical assays of metabolites of the brain neurotransmitter
dopamine (recall that reduced production of brain dopamine
causes the symptoms of Parkinson's disease). We found evidence
that the brains of ill Gulf War veterans with the syndrome 2
variant were overproducing dopamine. Other research shows that
dopamine excess can cause cognitive and emotional symptoms like
those described by many Gulf War veterans.
3. Abnormality of Autonomic Nervous System. We used special
computer modeling of 24 hour electrocardiogram (EKG) recordings
to test for subtle abnormalities of the autonomic nervous
system, which we suspected of causing symptoms like chronic
diarrhea, sexual disturbance, excessive gallbladder disease,
unrefreshing sleep and body temperature dysregulation. The
results were consistent with loss of the normal day-night
fluctuation in parasympathetic nervous system activity, which
would indicate abnormal function of the autonomic nervous
system. This abnormality was equally present in all three of
the syndrome variants.
4. Locating Damaged Brain Areas. A fascinating experiment
involved performing a SPECT scan of brain blood flow before and
after infusion of a drug physostigmine that safely mimics the
brain effects of sarin, OP pesticides and PB. Our prediction
was that if the ill veterans' brains had been damaged by these
neurotoxic chemicals, their brain function would not respond
like normal subjects to a repeat exposure. The findings were
consistent with the prediction. In normal Gulf War veterans,
the medication appeared to reduce blood flow, but it
paradoxically increased blood flow in the ill Gulf War veterans
with the syndrome 2 variant and showed other abnormal patterns
in the syndrome 1 and 3 variants. A provisional diagnostic test
modeled from these data discriminated each of the syndrome
variant groups from each other and from the well veterans.
Equally important, this experiment gave evidence that specific
parts of the brain appeared to be damaged and not responding
normally. These findings gave us a valuable starting place for
designing the next round of studies probing specific brain
areas found here to be abnormal.
5. Discovery of a Susceptibility Gene PON1. To try to explain
why some Gulf War veterans developed this chronic
encephalopathy while others working next to them did not, we
studied the function of a susceptibility gene called PON1 that
produces the blood enzyme paraoxonase that protects our brains
from neurotoxic chemicals like sarin and OP pesticides. We
found indeed that the ill Gulf War veterans were born with
abnormally low levels of paraoxonase, making them highly
susceptible to these neurotoxic chemicals; whereas, the well
veterans were born with normal to high levels. We then
developed a gene therapy product containing the PON1 gene,
injected it into mice, and found that it protected their brains
from damage caused by exposure to OP pesticides. The university
has a patent application pending, and if awarded, a possible
product to protect people from OP pesticide and nerve agent
exposure might result.
Development of New Technology To Measure Subtle Brain Abnormalities,
2001-2006
During the second round of studies it appeared that the brain cell
damage in Gulf War illness is sufficiently subtle that the approach we
had been using would not be sufficient and that we would have to
develop new technology, or adapt existing cutting-edge technology, to
thoroughly understand the condition and develop clinically useful
diagnostic tests. Therefore over the next 5 years we concentrated on an
intense technological development effort. To make this possible, we
enlisted some of the top brain scientists and technology experts from
the North Texas region and from universities throughout the country.
These included the University of Texas at Arlington, the University of
Texas at Dallas, Southern Methodist University, and the Johns Hopkins
University, Emory University, and University of Florida schools of
medicine
Again with stalwart support from Senator Kay Bailey Hutchison,
additional funding was provided through the Department of Defense to
accomplish the following technological development projects.
1. A New High Performance Brain Imaging Center Dedicated to
the Problem. UT Southwestern Medical Center dedicated space in
the imaging center for the most powerful FDA-approved MRI
scanner (with 3 Tesla strength), with all the peripheral
equipment configured for brain imaging studies of Gulf War
illness, opened in 2004.
2. High Resolution Imaging of Small Brain Structures. Our
physicists developed new MRI techniques to obtain very high
resolution images of small brain structures, such as the
brain's center for memory (the hippocampus) and sensation (the
individual nuclei of the thalamus) not normally visualized
adequately in standard MRI scans.
3. Rapid MRI-Based Tests to Replace SPECT. Although the prior
SPECT study was very successful and offered a possible future
diagnostic test for Gulf War illness, the protocol required two
full afternoons and exposed the research subjects to radiation,
both characteristics that reduce its usefulness in a diagnostic
clinic setting. We therefore adapted an emerging MRI-based
technique called Arterial Spin Labeling (ASL) that can obtain
the same information as SPECT but in a 3-hour test on 1 day
without radiation exposure. After validation, a provisional
patent application was filed.
4. Functional MRI (fMRI) Tests to Probe Symptoms. The central
problem in diagnosing and treating veterans with Gulf War
illness is that the veterans' complaints are all subjective
symptoms with no objective signs. To provide medical
understanding of the symptoms, we developed for each symptom an
fMRI ``probe'' to demonstrate observably how the brain is
functioning when a Gulf War veteran experiences a given
symptom. We developed an fMRI test to probe each of the major
symptoms, such as problems with fatigue, memory, attention and
concentration, word-finding, rapid thinking and reaction
(executive function), body pain, depressed feelings, and
emotional lability.
5. MRI and EEG Tests of Functional Connections among Brain
Structures. To assess the effects of brain cell damage on
overall brain function, we adapted cutting-edge technology
called Functional Connectivity to measure the amount of
``electrical traffic'' among brain areas. This measures how
much different brain areas are ``talking'' with each other.
Damage to a given brain area, or the ``wires'' between them,
reduces or eliminates the electrical transmission between them
and usually causes the brain to establish alternate ``work
around'' pathways that bypass the deficit. Knowing the state of
the functional connections could inform rehabilitation
treatments.
6. MRI-Based Tests of the Brain's ``Wiring.'' Some chemicals
are known to damage the nerve bundles that connect different
parts of the brain, and they can damage either the nerve
bundles themselves or the insulation (myelin sheath) that
covers the nerve bundles. To measure these we developed a test
using the MRI-based technology Diffusion Tensor Imaging (DTI).
This approach was used by Japanese researchers to demonstrate
brain abnormalities in survivors of the terrorist sarin attack
in the Tokyo subway, who were left with a chronic
encephalopathy similar to that in Gulf War veterans.
7. High Resolution EEG. While MRI-based brain imaging shows
spatially what is going wrong in the brain at a given point in
time, we have developed a high-resolution
electroencephalography (EEG) laboratory to measure the timing
of sequential events in the brain pathways damaged by Gulf War
chemical exposure. EEG testing is relatively quick and cheap
and is likely to figure importantly in a clinical diagnostic
strategy. Its high resolution implementation could also
discover the order and timing of brain events amenable to
rehabilitation treatment strategies.
8. Innovative Statistical Tests to Maximize the Power of
Brain Imaging Tests. Since the cutting-edge brain imaging
techniques being used are barely a decade old, few
sophisticated statistical techniques have been developed for
analyzing the complex data, and the relatively crude techniques
available are typically not very powerful in detecting the
types of subtle brain abnormalities that affect ill Gulf War
veterans. We therefore developed a new body of statistical
theory and applications that greatly increase the power of
brain imaging tests and have incorporated them into a software
package for which a patent is pending. This should have wide
application beyond this program.
9. PON Laboratory. In the past the laboratory techniques used
to measure the paraoxonase enzyme activity and the different
forms of the PON1 gene that protect us from low-level nerve
agents and OP pesticides have required time-consuming test tube
chemistry not feasible to apply to large numbers of veterans in
research studies. To overcome this we set up a special PON
Laboratory headed by an expert on PON chemistry, and he has
developed rapid, high throughput assays that can be used in
large-scale studies.
10. National Survey. In the first two phases of our research,
we performed our studies on Gulf War veterans from a single
naval reserve Seabees Battalion. To determine whether the
findings in this Battalion apply to the larger population of
Gulf War veterans in general, we collaborated for a number of
years with the well known research organization Research
Triangle Institute International (RTI) in designing a computer-
assisted telephone interview survey to apply in a randomly
selected sample of all Gulf War veterans. Subsamples of the ill
and well veterans selected from this nationally representative
sample will be studied by the new brain imaging techniques.
11. Mouse Model of Chemical Brain Damage. To develop effective
treatments for a new disease it is often necessary to
understand how the disease-producing process works at the
cellular and molecular levels so that new drugs or
rehabilitation strategies can be directed precisely at the
offending element. To make this kind of research possible, our
Neurotoxicology Laboratory has developed a mouse model in which
we can administer the neurotoxic chemicals to laboratory mice
by a carefully tested recipe that results in a chronic
behavioral disturbance comparable to Gulf War illness in
humans. The brains of these mice can be studied by
neuroscientists to discover exactly if and how neurotoxic
chemicals damage brain cells.
Third Round of Studies, 2007-Present
After more than a decade since the initial research results on ill
Gulf War veterans and with the new testing technology for studying
subtle brain damage now in hand, Senator Hutchison championed and
spearheaded a substantial new Gulf War illness research program through
the VA hopefully to gain a higher level of understanding of the
disease, a practical diagnostic approach, and ideas for treatment to be
tested in clinical trials. The research program, designed to implement
the 2004 Research Recommendations of the VA Research Advisory Committee
on Gulf War Veterans' Illnesses (RAC), has three basic components:
1. A National Survey and Serum/DNA Bank of Gulf War-Era
Veterans
2. A Series of Neuroimaging and Biomarker Studies
3. Pre-Clinical Studies of the Mouse Model
These components were designed on an ``industrial model'' much like
a defense contract program to develop a major new weapons system. All
of the components were developed to interact with each other so that
the findings of each would inform the progress of the others. At
present we are approximately 2 years into the National Survey, 18
months into the Neuroimaging studies and 9 months into the Pre-Clinical
studies. The following are summaries of progress to date.
National Survey and Serum/DNA Bank of Gulf War-Era Veterans. To
date we have completed the extensive standardized telephone interview
with 8,018 Gulf War-era veterans to measure the manifestations of the
illness, risk factors, and family impact of the illness. By the end of
August, we should have completed the field work for collecting and
banking serum, plasma, RNA, and DNA from all of the ill veterans and a
random sample of well veterans, comprising a total of approximately
2,100 survey participants. The following are provisional findings from
the initial analysis of the survey data.
Provisional finding: Regardless of the case
definition used, chronic Gulf War illness appears to be 3- to
4-times more common in the deployed than the non-deployed Gulf
War-era populations, and this difference is statistically
significant in the studies thus far.
Provisional finding: The findings support the
conclusion of the 2004 and 2008 RAC reports that, from
subtracting the prevalence of Gulf War multisymptom illness
(CDC definition) in the non-deployed population from that in
the deployed population, in 2007-2008 approximately 23 percent
of the deployed force still had the chronic multisymptom
illness from deployment-associated exposures.
Provisional finding: The three clinical variants of
the Gulf War illness, described in our prior studies, were
identified again and appear to be strongly validated in the
data from the national sample. This suggests that the chronic
multisymptom illness identified in the Seabees unit by our
prior studies is the same as that affecting the larger
population of Gulf War veterans.
Provisional finding: In the naval reserve Seabees
Battalion surveyed first in 1995, the prevalence rate of Gulf
War illness appears to have remained relatively unchanged over
the intervening 12-13 years, except that the milder syndrome 1
variant initially affecting younger Gulf War veterans tended to
have evolved toward the more severe symptoms of the syndrome 2
variant as these individuals aged.
Further analyses of the survey data are proceeding,
assays of paraoxonase enzymes and PON1 genes are nearly
complete, and we have selected subsamples of ill and well
veterans to participate in the next phase of the Neuroimaging
and Biomarker Study.
Neuroimaging and Biomarker Study. Because of the complexity of
studying a new brain disease, this component was designed in at least
three sequential phases: a) conducting developmental pilot studies to
validate the new neuroimaging techniques in normal volunteers, b)
performing the complete battery of new tests on the members of the
Seabees Battalion studied previously to see whether the disease had
changed in the decade since the prior studies and to confirm whether
the new tests detect the targeted abnormal brain function, and c) final
verification of the findings in random subsamples of the participants
in the National Survey of Gulf War Veterans. Provisional findings are
as follows.
Provisional finding: Findings of the prior SPECT
experiment were reproduced, and we verified that MRI-Based ASL
provides comparable results as the more involved and invasive
SPECT, providing a far more efficient and safer diagnostic
test.
Provisional finding: The prior MRS findings of
chemical abnormalities in deep brain structures (basal ganglia)
were reproduced, and the findings were extended to
abnormalities in hippocampus.
Provisional finding: DTI identified a mild
abnormality of myelin in white matter in ill Gulf War veterans.
Provisional finding: EEG found an increase in slow
brain waves in ill Gulf War veterans consistent with neurotoxic
brain injury.
Provisional finding: Functional Connectivity tests
identified abnormal increase in brain communication in ill Gulf
War veterans, indicative of generalized brain hyperarousal.
Provisional finding: fMRI tests identified abnormal
brain patterns underlying the major symptoms in ill Gulf War
veterans.
fMRI test of Learning and Remembering
identified abnormal function in the brain's memory
center (hippocampus).
fMRI test of Working Memory found that ill
veterans do not use the normal rapid memory pathways
but, instead, an inefficient slower work-around
pathway.
fMRI test of Attention and Concentration
identified abnormal function in deep brain structures
that normally direct attention and concentration (basal
ganglia).
fMRI test of Word Generation identified
abnormal function in the basal ganglia.
fMRI test of Pain Processing found
exaggerated response to pain sensation in the cerebral
cortex.
fMRI test of Emotional Control found
activation of abnormal pathways for managing
emotionally evocative stimuli.
High Resolution MRI images have identified abnormal
cavities in the brain's memory center (hippocampus) in ill
veterans, suggesting chronic effects of brain cell damage.
Provisional Conclusions
In our latest study of the Seabees battalion, virtually every
neuroimaging test showed evidence of substantial differences between
sick and well groups of Gulf War veterans. This suggests that our
unique brain imaging program might explain most symptoms and provide
powerful objective diagnostic tests for clinical use and determination
of service-connected status. It also provides a rich mosaic of evidence
to suggest mechanisms of the brain dysfunction to be further tested in
our pre-clinical mechanistic studies the third component of the ongoing
program).
The uniform success of the tests is due to our strategy for
developing the imaging tests by targeting veterans' symptoms and the
brain regions known to perform the implicated functions and the
clinical classification of veterans into the three syndrome variants
identified in our initial studies. Since the findings differ somewhat
among these clinical variants, failing to test and analyze the groups
separately would have resulted in less powerful, or even negative,
findings.
As far determining which neural mechanisms are in play, we have not
analyzed the data sufficiently yet to favor one mechanism over others.
We can state the following general working hypotheses about mechanisms:
a. Although we find evidence of abnormalities in both deep
gray matter and white matter, primacy of the deep gray matter
involvement seems likely (e.g., pain is not a symptom of
primary diseases of white matter).
b. Deep gray matter abnormalities identified appear
bilaterally asymmetrical.
c. White matter abnormality appears to involve myelin, rather
than axonal, degeneration. If correct, this is optimistic for
treatment; myelin may be more amenable than axonal damage.
Besides explaining the specific deficits, the mosaic of evidence
points to certain general findings:
a. Structures activating during a task in well veterans often
do not activate in sick veterans, but other structures do. This
abnormal activation probably indicates the brain's attempts to
compensate for, or work around, damaged areas.
b. The brain in sick veterans appears to be hyper-aroused and
hyper-responsive to stimuli.
1. The brain appears to be working overtime to
overcome the many deficits.
2. Chronic fatigue may be due to the brain's
exhaustion from this overwork.
3. The emotional lability and hyper-reactivity may
also be due to this overwork.
Next Steps
The symptoms of veterans suffering from Gulf War illnesses are
subjective, and the causes, diagnoses, and treatments are elusive.
Therefore, a guiding principle for this research program has always
been that objective studies--verified by researchers at different
institutions and replicated in representative and increasingly-large
samples of veterans--are required to arrive at conclusions on which
action can be based.
With this rigorous approach, the findings to date make us
optimistic that this multi-perspective testing protocol might lead to
objective diagnosis. If it continues to progress along these lines, the
testing approach should prove useful for future clinical and research
work in the following ways:
a. Developing an objective diagnostic testing protocol for
clinical work and service connection.
b. Providing pathogenetically homogeneous groups for clinical
trials so that promising treatments can be tested with far
fewer participants, and thus with less time and cost.
In the next phase of the Neuroimaging and Biomarker Study beginning
shortly, we are preparing to process through the successful brain
imaging protocol at least 80 Gulf War veterans selected randomly from
the National Survey of Gulf War-Era Veterans representing the three
syndrome variants and well control veterans. The findings in this
sample will examine the previously raised hypotheses about the nature
of Gulf War illness in the larger population of Gulf War veterans--a
vital step that is required before any of the prior findings can be
considered strongly supported.
Selected Scientific Papers Published from the Program
1. Haley RW, Kurt TL, Hom J. Is there a Gulf War syndrome?
Searching for syndromes by factor analysis of symptoms. Journal
of the American Medical Association 1997;277:215-222.
2. Haley RW, Hom J, Roland PS, Bryan WW, Van Ness PC, Bonte
FJ, Devous MD, Mathews D, Fleckenstein JL, Wians FH, Wolfe GI,
Kurt TL. Evaluation of neurologic function in Gulf War
veterans: a blinded case-control study. Journal of the American
Medical Association 1997;277:223-230.
3. Haley RW, Kurt TL. Self-reported exposure to neurotoxic
chemical combinations in the Gulf War: a cross-sectional
epidemiologic study. Journal of the American Medical
Association 1997;277:231-237.
4. Hom J, Haley RW, Kurt TL. Neuropsychological correlates of
Gulf War syndrome. Archives of Clinical Neuropsychology
1997;12:531-544.
5. Haley RW. Is Gulf War syndrome due to stress? The evidence
reexamined. American Journal of Epidemiology 1997;146:693-703.
6. Haley RW. Point: Bias from the ``healthy-warrior effect''
and unequal follow-up in three government studies of health
effects of the Gulf War. American Journal of Epidemiology
1998;148:315-323.
7. Haley RW, Billecke S, La Du BN. Association of low PON1
type Q (type A) arylesterase activity with neurologic symptom
complexes in Gulf War veterans. Toxicology and Applied
Pharmacology 1999;157:227-233.
8. Roland PS, Haley RW, Yellin W, Owens K, Shoup AG.
Vestibular dysfunction in Gulf War syndrome. Otolaryngology--
Head and Neck Surgery 2000;122:319-329.
9. Haley RW, Marshall WW, McDonald GG, Daugherty M, Petty F,
Fleckenstein JL. Brain abnormalities in Gulf War syndrome:
evaluation by 1H magnetic resonance spectroscopy.
Radiology 2000;215:807-817.
10. Sinton CM, Fitch TE, Petty F, Haley RW. Stressful
manipulations that elevate corticosterone reduce blood-brain
barrier permeability to pyridostigmine in the rat. Toxicology
and Applied Pharmacology 2000;165:99-105
11. Haley RW, Fleckenstein JL, Marshall WW, McDonald GG,
Kramer GL, Petty F. Effect of basal ganglia injury on central
dopamine activity in Gulf War syndrome. Archives of Neurology
2000;57:1280-1285.
12. La Du BN, Billecke S, Haley RW, Broomfield CA. Serum
paraoxonase (PON1) isozymes: the quantitative analysis of
isozymes affecting individual sensitivity to environmental
chemicals. Drug Metabolism and Disposition. 2001;29:566-569.
13. Haley RW, Luk GE, Petty F. Use of structural equation
modeling to test the construct validity of a case definition of
Gulf War syndrome: invariance over developmental and validation
samples, service branches and publicity. Psychiatry Research
2001;102:175-200.
14. Cowan J, Sinton CM, Varley AW, Wians FH, Haley RW, Munford
RS. Gene therapy to prevent organophosphate intoxication.
Toxicology and Applied Pharmacol. 2001;173:1-6.
15. Haley RW, Maddrey AM, Gershenfeld HK. Severely reduced
functional status in veterans fitting a case definition of Gulf
War syndrome. American Journal of Public Health 2002;92:46-47.
16. Haley RW. Excess incidence of ALS in young Gulf War
veterans. Neurology 2003;61(6): 750-756.
17. Haley RW. Gulf War syndrome: narrowing the possibilities.
Lancet Neurol. 2003;2:272-3.
18. Haley RW, Vongpatanasin W, Wolfe GI, Bryan WW, Armitage R,
Hoffmann RF, Callahan TS, Charuvastra E, Shell WE, Marshall WW,
Victor RG. Blunted circadian variation in autonomic regulation
of sinus node function in veterans with Gulf War syndrome.
American Journal of Medicine 2004;117(7): 469-478.
19. Spence JS, Carmack PS, Gunst RF, Schucany WR, Woodward WA,
Haley RW. Increasing the power of group comparisons in SPECT
brain imaging through spatial modeling of intervoxel
correlations. JASA Journal of the American Statistical
Association 2007;478:464-473.
20. Haley RW, Spence JS, Carmack PS, Gunst RF, Schucany WR,
Petty F, Devous MD Sr, Bonte FJ, Trivedi MH. Abnormal brain
response to cholinergic challenge in chronic encephalopathy
from the 1991 Gulf War. Psychiatry Research Neuroimaging
2009;171: 207-220.
Prepared Statement of Roberta F. White, Ph.D., Professor and
Chair, Department of Environmental Health, and Associate Dean for
Research, Boston University School of Public Health, Boston, MA
Good morning, Chairman Mitchell, Ranking Member Roe, and Members of
the Committee.
This morning I will talk about my experience with Gulf War veterans
over the last 16 years and their health problems. I will speak from a
research perspective on the epidemiologic investigations in which I
have participated examining health outcomes related to chemical
exposures in Gulf War veterans. I will also talk about my clinical
experience in working with veterans as a neuropsychologist at the VA
and in university medical center settings. My aim is to integrate these
two sources of experience in order to provide a better understanding of
the challenges involved in understanding and treating Gulf War Illness.
As mentioned in my prior testimony, our research efforts in Boston
over the last 16 years or so have focused on relationships between
exposures experienced in the Gulf War and health outcomes, carefully
controlling for stress symptoms, diagnosis of post-traumatic stress
disorder, psychiatric diagnoses, and other variables that affect
neuropsychological test performance, questionnaire responses and
neuroimaging results. These studies have led to the following
conclusions:
1. Pesticide exposures in Gulf War veterans are associated
with increased health symptoms, especially those involving the
central nervous system. Such exposures are also associated with
poorer neuropsychological test outcomes and with chronic
multisymptom illness. These results are consistent with the
occupational literature.
2. Exposure to pyridostigmine bromide (PB) is also associated
with neuropsychological test outcomes.
3. Mixed exposure to high levels of pesticides and PB is
associated with more severe effects, including elevated health
symptom complaints, poorer neuropsychological test outcomes and
chronic multisymptom illness.
4. Exposure to nerve gas agents (Sarin/Cyclosarin) in
Khamisyah is associated with poorer neuropsychological test
performance and smaller white matter volumes in the brain in a
dose-effect manner: higher exposure predicts greater pathology.
These results are consistent with those seen following Sarin
exposures in Japan, and the functional findings based on
neuropsychological testing are of the type that would be
expected with lowered white matter volumes.
5. Gulf War veterans with higher numbers of symptom complaints
have smaller white matter volumes on magnetic resonance brain
imaging than those with low numbers of symptoms.
It is important to note that the above findings were seen in
veterans who were not diagnosed with clinical illness by physicians.
They did not have diagnosed brain damage nor were their
neuropsychological or brain imaging results considered to be in the
abnormal range. Most of the study participants were working at the time
of their study participation. The epidemiological study results suggest
that there are subtle changes in brain structure and function
associated with chemical exposures. Such changes are often referred to
as ``subclinical'' central nervous system effects of exposure. The
research results suggest that these exposures are also associated with
significant experience of poor health and dysfunction in daily life.
How do such findings relate to the clinical examination of
individuals with exposure to pesticides and other neurotoxic chemicals?
When patients are seen clinically, neuropsychological test results and
brain imaging can be interpreted as being normal even among patients
who experience significant health symptoms and functional problems in
daily life. This reflects the insensitivity of the diagnostic tests
available as well as other factors. Gulf War veterans often show this
picture, and it can be perplexing to clinicians when they observe poor
health and multiple symptom complaints in individual patients. This may
lead to confusion about diagnosis, treatment options available for
patients, and even whether to accept the patient's complaints at face
value.
The clinical and research evidence suggest that health symptom
complaints in Gulf War veterans should be taken seriously, especially
if the veteran has known exposure to neurotoxicants in theater. These
include pesticides, PB and Sarin/Cyclosarin gas exposure. Diagnosis of
post-traumatic stress disorder is made and compensated based on self-
report of psychological symptoms in the context of a significant
stressor. Self-reported physical symptoms and dysfunction in daily life
deserve to be taken just as seriously.
[The attached reports, ``Quantitative Magnetic Resonance Brain
Imaging in U.S. Army Veterans of the 1991 Gulf War Potentially Exposed
to Sarin and Cyclosarin,'' by Kristin J. Heaton, Carole L. Palumbo,
Susan P. Proctor, Ronald J. Killiany, Deborah A. Yurgelun-Todd, and
Robert White, in NeuroToxicology 28 (2007) 761-769, dated July 19,
2006; and ``Effects of Sarin and Cyclosarin Exposure During 1991 Gulf
War on Neurobehavioral Functioning in U.S. Army Veterans,'' by Susan P.
Proctor, Kristin J. Heaton, Tim Heeren, and Roberta F. White, in
NeuroToxicology 27 (2006) 931-939, dated May 26, 2006, will be retained
in the Committee files.]
Prepared Statement of Anthony Hardie, Madison, WI,
Gulf War Veteran Member, Research Advisory Committee on
Gulf War Veterans' Illnesses
Chairman Mitchell, Ranking Member Roe, and Members of the
Subcommittee:
Thank you for inviting Members of the Research Advisory Committee
on Gulf War Veterans' Illnesses to testify today regarding the
implications of the U.S. Department of Veterans Affairs' limited scope
of Gulf War Illness research. I am honored to fulfill the
Subcommittee's request to testify today as a Gulf War veteran regarding
my own personal experiences, observations, and recommendations on these
issues.
My experiences are far from unique, and I am sharing them in the
hope that it will help to better inform the Subcommittee and in turn
assist the countless thousands of my fellow Gulf War veterans who, like
me, have been injured and ill for nearly two decades following the war
without effective treatment.
Like 175,000 to 210,000 of my fellow Gulf War veterans, I have had
significant health issues that began during my deployment to the Gulf
more than 18 years ago, and like them have experienced a profound
negative impact due to the sharply limited scope of VA's Gulf War
Illness research program. To put things into perspective, in 1991, I
was a young, fit, 22-year-old special operations soldier tasked to the
multi-national Coalition-led Joint Forces Command-East when the war
began, and I turned age 23 while in Khafji, Saudi Arabia (near the
Kuwaiti border) just days before we moved across the border into
Kuwait.
PB. In mid-January, my team of about 30 men was directed to begin
taking the PB (Pyridostimine Bromide) nerve agent protective pills that
we had all been issued. We were told that they were experimental, not
FDA-approved, that we had no choice in consenting and were ordered to
take them, and that we would probably experience symptoms similar to
mild nerve agent poisoning. Like tens of thousands of my fellow Gulf
War veterans, I experienced significant side effects, including watery
eyes, runny nose, confusion, dizziness, muscle twitching, diarrhea,
weight loss, and generally feeling quite ill. For me, like so many
others, the acute symptoms lasted for at least as long as I took the
pills, which was for a number of weeks.
Today, science has shown that these experimental pills we took,
along with the industrial-strength pesticides so many of us used and
overused are implicated as causes of our lasting Gulf War Illness. Yet,
despite research showing the negative impact of PB in combination with
pesticides at least as early as a 1990s Duke University study funded
not by VA, but by Ross Perot, VA's limited scope GWI research has yet
to develop effective treatments, diagnostic tests to assess the damage,
advisements on what to do or not to do, or even informational materials
in order to help improve the health and lives of the one-fourth to one-
third of us Gulf War veterans who have been and remain ill.
Fog of War. Because of the much vaunted technological advances of
the 1991 Gulf War displayed around the clock on the nascent CNN, it is
easy to understand why there seems to be a persistent belief here in
U.S. that for the first time in history, there was no ``fog of war''
during the 1991 Gulf War. On the ground, it was a different story.
When the first SCUD missiles were fired, ground troops near the
border like me were concerned about them hitting our locations because
the Iraqi political-military strategy was not yet understood.
When more than 700 of Kuwait's oil wells were lit on fire, Islamic
and non-Islamic forces alike quietly discussed whether the midnight-
darkness at noon was some sort of cataclysm, before the unprecedented
cause of the unnatural, midday inky blackness became known.
When chemical alarms sounded or silkworm missiles came in, a denial
cycle between forward and theater command levels led to a widespread
belief that the tens of thousands of alarms--even those double-and
triple-verified as accurate--were simply faulty. During the war, my
team's chemical alarms went off a number of times. Like most other Gulf
War troops, we were told that the Iraqis had not used or even forward-
deployed their chemical weapons and the alarms must have been sand or
some other false alarm. After the war, it was publicly revealed that
tens of thousands of alarms went off throughout the Gulf War theater of
operations. One day in particular, I remember receiving communications
that a nearby unit at R'as al-Mishab had been hit with chemicals
[chemical warfare agents]. We later received communication that the
chemicals had been confirmed. Later, it was discounted as a false
alarm, despite the second confirmation. This story is far from unique,
with Gulf War veterans having echoed similar stories in previous public
testimony.
When we moved forward to the evacuated Kuwaiti border city of
Khafji, a nighttime missile sounding like a train overhead killed about
a dozen Senegalese troops where we had just left. Another night, we
were the target of a multi-volley Iraqi artillery raid. Given the
unexplained, severe, painful skin rash all over the exposed skin on my
face and hands on one of those nights, as I had slept under the only
open window in the building, I have long wondered about its cause and
effects.
When we launched into southeastern Kuwait with Coalition forces,
unlike further to the west, we encountered no resistance. We were able
to quickly move into Kuwait City, where we took over the former Iraqi
command center, replete with a room-sized sand-table map of Kuwait
covered with chemical warfare and other symbols that was the object of
great interest to the CENTCOM officers who flew in the following day,
before the facility was closed off permanently for the remaining nearly
2 months I was in a neighboring building near the Kuwaiti International
Airport.
HD/L/HL. In the days that followed the informal end of the ground
war, small teams from my ``unit'' combed through former Iraqi sites in
Kuwait and Iraq, assessing them, gathering information, and even
picking up the occasional souvenir.
In one bunker complex north of the Kuwait bay that a handful of us
went through, I was captivated by the lovely fragrance that smelled
just like the large red flowers that filled my grandmother's garden
back home and pervaded Iraqi bunkers so hastily evacuated that plates
of half-eaten food and loads of personal gear had been left everywhere.
Along with the lovely, captivating geranium fragrance was the
pervasive odor that I thought was wet onions. I found this very odd at
the time because there were no onions to be found in even the emptiest
of the bunkers.
If I had been looking at a watch, I could have told you shortly
thereafter what the time and date was when my severe, chronic cough
began. Like many Gulf War veterans (and Iranian veterans of the Iran-
Iraq War who preceded us), it has never subsided. For years, I believed
that my black sputum that I coughed up for 3 months, and the never-
ending cough that continued thereafter, was the result of the oil well
fire smoke.
Years later, I was horrified to learn that what I smelled that day
were the characteristic odors of Lewisite and Mustard, a classic
mixture used heavily by the Iraqis during the Iran-Iraq war. Even
still, I discounted that my severe respiratory illness that began very
shortly thereafter could have been because of these blister agents, not
knowing until more recently that while the damage is immediate, the
symptoms of mustard agent exposure don't show for as long as even 24 to
48 hours after exposure, and that the vapors I inhaled that day--by the
fact that they were strong enough to be smelled--were also strong
enough to do immediate and lasting damage to my entire respiratory
tract that corresponds with my symptoms at the time and since.
After talking with my doctors, the soft, blackish chunks I coughed
up at the end of the Gulf War, some as wide across as a dime or larger,
were almost certainly not oil well fire residue, but instead soot-
tinged lung tissue being sloughed off after being blistered by these
Iraqi chemical warfare agents. And notably, because there were only two
or three of us in those bunkers, with me in them the longest, and
because none of us were well trained enough to ever recognize these
characteristic odors, they were never reported--except to my family, as
ironically I searched after the war in Arab shops for the uniquely
fragrant, geranium-scented perfume to buy for my mother that I was
certain the retreating Iraqi troops had been using so heavily that it
had left its scent behind in those bunkers.
I have heard enough firsthand accounts from other Gulf War ground
troops about coming across chemical mines, being hit with isolated
chemical attacks, and more that I now firmly believe that the CIA and
DoD has no basis for their long-held statements that Iraqi ground
commanders never possessed or used chemical weapons during the war. The
extent and impact of intelligence failures were widely discussed on and
off the battlefield, and if there is further interest and a proper
request to do so, I would be happy to provide more information in a
closed setting on this issue.
Sadly for at least 175,000 of my fellow ill Gulf War veterans, VA's
limited scope of GWI research has not even begun to address the health
outcomes associated with widespread chemical warfare agent exposures,
let alone treatments, information, or advisements that might help
improve our health and lives.
Some time following my redeployment to Ft. Bragg, I sought health
care at the Troop Medical Clinic (TMC) on ``Smoke Bomb Hill.'' After
explaining during triage that my ``Kuwaiti cough'' was unrelenting and
often led to vomiting, I overheard a discussion about me just outside
the exam room, ``He's another one those Gulf War veterans who `thinks'
he's sick.'' I vowed to myself to never seek treatment again until
after I was out of the military, assuming that the VA would be able to
fix me up in no time. Meanwhile, based on my cough, which was the worst
in the mornings and after running, I was ``diagnosed'' with ``post-
exertional asthma'' and given an inhaler, which one of my similarly
diagnosed, fellow Gulf War veterans and I nicknamed our ``Kuwaiti badge
of pride.''
Like many of my returning fellow Gulf War veterans, I did my best
to deal with the chronic cough, fatigue, abdominal pain, diarrhea,
nausea, dizziness, and cognitive impairment that began before returning
home and just wouldn't subside. Some of my fellow soldiers also
suffered from skin rashes and a variety of other symptoms.
I only just began to realize how wrong I was about finally getting
proper health care from the VA, when at one of my earliest VA
appointments in Milwaukee shortly after leaving the military, I tried
unsuccessfully to put words to what was wrong with me, and was told by
the clerk, ``Well, we're all confused.'' Like many of my fellow
veterans from Somalia, I was diagnosed with PTSD. A few months after my
discharge, I had a recurrence of malaria as well, though I could get no
treatment for it from VA because I had been denied service-connection.
Instead, I called a buddy back at Ft. Bragg, who gladly mailed me the
pills, and I haven't had a recurrence since--no thanks to VA, which to
this day has denied my service-connection for malaria as well.
A year or two later, having moved to Madison, the designated Gulf
War coordinating doctor's agitated words burned forever into my memory
when she told me, ``There's nothing wrong with you Gulf War vets. It's
all in your heads, you just need to forget about it, get on with your
lives, and get past it.'' Even if it were ``just'' PTSD or TBI, which
it clearly wasn't, these words still ring in my ears as one of the most
commonly cited examples of VA's history toward Gulf War veterans that
has yet to be fully remedied, because the answers lie here in
Washington, in creating the political will to find effective treatments
that doctors in Wisconsin and across the country can implement with
their still-ill Gulf War patients. Like other Gulf War veterans I have
spoken with, what was most effective in finally getting taken seriously
was when Mental Health referred me to other medical specialties because
my chronic cough and other symptoms were clearly unrelated to any known
mental health condition.
However, by then, I had been in the VA system for about 3 years,
and it was now about 6 years after the war. I had served my country for
more than 7 years, much of it in sharply austere conditions in highly
underdeveloped countries, not to mention two tours under harsh combat
conditions. I found it unconscionable that they were treating my
brothers--and sisters-in-arms with such flagrant, caustic disregard.
Gulf War Illness. Like some Gulf War veterans, my chronic,
widespread pain and MS-like neurological symptoms have been diagnosed
and service-connected as fibromyalgia. Like a few Gulf War veterans, my
post-Gulf chronic, painful bowel disorder has been service-connected as
irritable bowel syndrome. Like many Gulf War veterans, my debilitating
chronic fatigue has been well documented. But, like nearly all other
ill Gulf War veterans, I am not service-connected for Gulf War Illness
or Gulf War Syndrome.
Despite special provisions in the law, Gulf War veterans have had
unique and special challenges due to the currently medically
undiagnosable nature of many of their health conditions. In fact, the
data from VA's most recent, December 2007 quarterly Gulf War Veteran
Information System (GWVIS) report--which it inexplicably discontinued
thereafter--shows that of the 272,215 claims filed by the 696,842
veterans of the 1991 Gulf War (a filing rate of almost 40 percent),
only 3,149 undiagnosed illness claims, equaling about 1 percent of all
claims filed, have been approved. The fact that only 1 percent of all
Gulf War veterans' claims filed have been approved for ``undiagnosed
illness'' violates both the letter and the spirit of the Persian Gulf
War Veterans Act 1998, which was clearly intended to help ill Gulf War
veterans receive expedited service-connection for their Gulf-related
chronic multi-symptom illness.
Like many Gulf War veterans, I have had chronic sinusitis and
chronic cough since the Gulf. Since my discharge, I have requested
again and again for VA to do a lung scope to go into my lungs to see
what it looked like, but at every turn was put off, told there were
other tests to do first, told there was no reason to do so. Again, my
cough has never subsided since it began in February/March 1991. This
Spring, after 18 years I was finally able to get a bronchoscopy, and
its results were yet one more bittersweet revelation--``red, irritated,
and angry-looking'', with a diagnosis of one type of chronic
obstructive pulmonary disease (COPD), chronic bronchitis. Due to VA's
limited scope of GWI research, I found this bittersweet victory on my
own, having gotten the test done privately after having found no
support from the VA for getting this test done for my 18-year-old
chronic cough, despite having firmly and repeatedly requesting it since
my very first VA encounter in 1994.
A reasonable person would conclude that all of these conditions,
which are anecdotally very common among Gulf War veterans, should be
presumptively service-connected and treated by VA under--take your
pick--``Gulf War Illness,'' exposure to Kuwaiti oil well fire smoke, or
exposure to sarin, cyclosarin, or blister-agent vapors. Yet despite all
the scientific evidence, VA has not yet made any of these and so many
more presumptive conditions for the tens of thousands of ill and ailing
Gulf War veterans whose struggles are at least as bad as my own, and
due to VA's limited scope of GWI research, there was not and still is
not help, or even an understanding of what to look for in us Gulf War
veterans.
The decline. Given the prevalent ``warrior'' mentality that
pervaded every aspect of military life, years later I would find it
extremely disingenuous that one early government study showed low rates
of hospital stays by Gulf War veterans, with the implication that there
really wasn't a problem and appeared to be one of the earlier attempts
to discount that anything was wrong with us. Like me, many of us Gulf
War veterans battled health issues and struggled to stay in the
workforce for years. As I have often said, if it weren't for the
military, I wouldn't have been able to keep on struggling, but then
again, if it weren't for the military, I wouldn't have had to.
Before the military, I was seen as a bright and promising boy, with
achievement test scores nearly always in the 99th percentile, being
academically recognized at an early age for reading hundreds of books
each year, being selected to represent my high school in high quiz
bowl, and so on. That factor, combined with my enduring warrior
mentality, has meant that my cognitive losses and challenges haven't
always been as visible to others who didn't know me before the Gulf
War. But for me, it has been extremely painful, with great difficulties
in even finishing a book, and short-term and working memory loss that
is much worse than my most elderly relatives and has required major
adaptation over many years and reliance on new skills, devices, and
assistance.
Submitted with my written testimony is a statement written by my
mother more than a decade ago in support of my VA claim. It could have
been written by any Gulf War veteran's mother, describing what she saw
in her son--all the symptoms, all the changes for the worse. These
observations are hardly unusual--spend a little time with any of us
175,000-plus ill Gulf War veterans and you'll see much the same thing.
Things have only gotten worse since then. For a few years, I
believed that my symptoms would just hold steady, and I kept working
harder and harder on veterans issues in a variety of roles, always
seeking to help find treatments and assistance for my fellow Gulf War
veterans. As things got worse, increasing amounts of caffeine and
energy drinks kept me going at about the same pace. I began to need
accommodations to continue working, trying to make a difference for
others. Finally, even all that didn't help, and like many other Gulf
War veterans, I kept getting worse, until finally this March, after a
fairly major thoracic surgery, I was simply unable to return to a
normal working life, and I'm now largely at home--not a fun thing when
you're only what you thought was mid-way into your career.
IOM Issues. Last November, the Research Advisory Committee issued
its exhaustive, definitive scientific report. In essence, the report
said in scientific terms what we ill Gulf War veterans have been saying
all along - that our Gulf War exposures made us ill, and that we've
been ill ever since. This final government acknowledgement was truly a
bittersweet victory.
Yet, more than 18 years after the Gulf War, VA has essentially
nothing to show for its efforts on behalf of ill Gulf War veterans
besides acknowledging that Gulf War veterans really are ill and that it
is the result of our military service. The VA has nothing new to offer
our Gulf War veterans to help improve our health and lives besides
procedural excuses. Like me, many of us have battled Gulf War related
health issues for that entire time. Today, there are no effective
treatments. It is time for this Congress and this administration to
truly leave no stone unturned in helping our Nation's countless
thousands of ill Gulf War veterans, who served their country, were
injured in war, but have yet to be taken care of as promised.
It is true that VA has retained an open door for Gulf War veterans
not yet enrolled in VA to be seen at VA medical facilities for priority
health care for Gulf War related conditions. And, the VA has made great
strides in reducing wait times for VA health care appointments, and
should be commended for this herculean achievement. Restoring Gulf-War
related (``enhanced'') enrollment in VA health care under Priority 6
should be an immediate, no-brainer priority and continued in
perpetuity. I wonder if I'm alone in finding it absolutely stunning
that VA allowed this provision to expire. Thankfully, Congressman Glenn
Nye (D-Virginia-02) has been successful in including this restoration
for Gulf War and Agent Orange veterans in the current National Defense
Authorization Act (NDAA), and I request for my fellow veterans that
Congress unanimously support this critically important amendment.
However, as I testified before Congress 2 years ago, being seen is
not the same thing as being treated. Coordinated team care is an
important VA advance. Just like for me, many Gulf War veterans have
told me that their treatment has consisted of suppressing individual
symptoms, but without any apparent understanding of the underlying
mechanism of their chronic multi-symptom illness. Treatment based on a
scientific understanding of the underlying mechanisms of Gulf War
Illness and not just focused on symptom-management is of key
importance, and I believe is within our reach.
Flawed Research Efforts. There are a number of important, negative
outcomes that have resulted from VA's failure to adequately assess,
monitor, and treat ill Gulf War veterans like me through its halting,
piecemeal, seriously flawed research program.
Clinicians at local VA hospitals still, after 18 years, seem to
have had no idea what to make of, or to do for Gulf War veterans. In my
experience, nearly all have been competent and compassionate
professionals who have sought to treat every symptom they could. I
stated in my testimony before another House Veterans Affairs
Subcommittee in 2007 that being seen is not the same thing as being
treated. What I meant by that was that having countless VA
appointments, resulting in no effective treatment for the underlying
injury or illness and only limited symptom management, is really just
about as good as not being seen at all. As I said then, I know of many
Gulf War veterans who long ago gave up on getting effective or relevant
health care from VA years ago, with some seeking alternative or
experimental options and others simply struggling with their array of
debilitating symptoms as best they can.
Because of VA's research inadequacies, clinicians have not known to
tell us ill Gulf War veterans what to do that might help improve our
health and lives. In more recent years, it became clear throughout much
of the medical community that Gulf War illness is real. In my case, it
became clear to my doctors that Gulf War illness was real long before
its reality was acknowledged by the Federal Government or in the media,
though sadly, I have heard of Gulf War veterans as recently as this
Spring who are still being told that it's all in their heads.
Through recent, Federally funded research, we know that veterans
with PTSD who have subsequent traumatic exposures may get even worse.
And we now know that one of the most dangerous things for veterans with
even mild traumatic brain injury (TBI) is another brain injury while
the brain is still healing.
But, because of VA's research inadequacies, clinicians have also
not known to tell us ill Gulf War veterans what to avoid or be careful
of. VA and other doctors have not known to tell ill Gulf War veterans
to avoid at all cost any additional exposures to pesticides, paint
primers, and related chemicals. Like so many of my Gulf War veteran
friends, I've had to learn that the hard way, through personal
experience of the terrible effects of subsequent exposures. And, VA and
other doctors haven't been able to warn us of the terrible potential
effects of future injuries or illnesses involving inflammation, either.
Like many of my Gulf War veteran friends, I have also had to learn that
the hard way - in my case, it was a whiplash that was the straw the
broke the camel's back, with chronic widespread pain.
Finding old friends. In the last several months, many of my former
Army colleagues have found each other again via Facebook. While it
feels like ``coming home'' to be reuniting like this, it is also deeply
disheartening to learn how many are also continuing to suffer without
relief or effective treatments. As I have found and shared some old
pictures from back then, finding friends like Joel--a career soldier
who now lives in Iowa. When I had the honor and privilege of serving
with him, Joel was the epitome of what a special operations soldier
should be--smart, physically and mentally fit, a respected and beloved
leader, self-sufficient yet thrived on being part of or leading a team,
always ready at an instant to improvise, adapt, and overcome. And, Joel
is a multi-combat tour veteran, having at least three combat tours, if
not more. He's truly a hero to so many of us, so much so that he, and
others like him would never consider themselves so, saying he was just
doing his job. So it was all the more heartbreaking to learn that he's
now totally debilitated, disabled and at home, overcome by the chronic,
widespread pain that affects so many of us, and more health issues than
he can name. I can only say one thing about how VA's failures in
Washington and beyond have affected a decorated, multi-tour combat
veteran hero like Joel--THIS. IS. NOT. RIGHT.
These issues also affect women veterans. I was deeply saddened to
hear from Trish from Ohio--a friend with whom I had lost contact before
the war--that she, too, has suffered terribly since the 1991 Gulf War
with her Gulf War Illness. Another friend, Michelle in Maine is another
of the 175,000 who has such severe neurological issues that she's now
losing her eyesight, in addition to the debilitating array of chronic
multi-system symptoms that affect us all.
And there's Ed, from Missouri, who can barely walk due his muscle
and joint weakness and pain, and I could go on and on and on. Joel and
Trish and Ed and Michelle are not alone--they are just a few of the
thousands of ill Gulf War veterans that are in every state and every
Congressional district.
These are real people, who volunteered to serve their country and
to risk their very lives in service to our Nation. Yet, VA's limited
scope of research has failed, and continues to fail, all of us.
End Results. Like many Gulf War veterans, I have beliefs on how we
got to this point--where more than 18 years later, we have almost
nothing to show for it all (with the exception of the most recently
funded, promising, ongoing DoD and University of Texas-Southwestern
efforts)--no treatments, advisements, or adequate assistance to give
our ill Gulf War veterans. And, because we haven't fully learned the
lessons of the Gulf War toxic soup, our force protection measures
remain inadequate.
However, I won't discuss that here. And, later in this hearing
you'll hear from others more eloquent than me about how VA's
fundamentally flawed contracts with, and reliance on the subsequently
flawed reports issued by the Institute of Medicine has led directly to
today's most stark failure regarding Gulf War veterans' illnesses. The
greatest failure is one of outcomes--that more than 18 years after the
war, VA has essentially nothing to show for its ``efforts'' and little
or nothing to offer the one-fourth to one-third of all Gulf War
veterans who, like me, remain ill and with no effective treatments.
Recommendations. In addition to immediately directing VA to correct
the serious issues related to its contracts with IOM, here's what I
believe needs to be done this year, at a minimum:
First, the administration and Congress should take committing to
Gulf War illness research focused on treatments as seriously as recent
and ongoing efforts related to PTSD, traumatic brain injury (TBI), and
prosthetics development. In recent years, Congress has forcibly
appropriated large sums for these and as might be expected, the results
are already promising. Scientists who have made presentation before the
RAC have stated that effective treatments for Gulf War illness are
within our reach, and I believe they're right, if only we commit to
doing what's right for our ill Gulf War veterans.
At the present time, we have the skeleton of a research program but
the government needs to put some flesh and bones on it. The VA funded
program at the University of Texas-Southwestern, is focused on basic
research, looking for the mechanisms that underlie the illness. It
should be continued, though modified with the recommendations adopted
by the RAC to make it more comprehensive. VA should also substantially
expand its internal research as recommended in the RAC Report.
DoD also has a critical role to play. Historically it has provided
two-thirds of Gulf War research funding, but it has zeroed out those
programs since the start of the current wars. In response, Congress has
created a Gulf War research program within the DoD Congressionally
Directed Medical Research Program. This is a very exciting program,
open to all researchers, which is focused on small pilot studies of
drugs and other treatments already approved for other diseases. So the
payoff could be much quicker than the basic science approach. However,
the program is not budgeted by DoD, so ill veterans and their handful
of advocates have to struggle to keep it alive each year in competition
with earmarks. It is extremely underfunded--just $8 million in FY09 for
research to find treatments for at least 175,000 ill Gulf War veterans.
It should be fully funded at the $40 million level recommended by the
RAC. And DoD should have a high interest in having treatments available
so this doesn't happen again.
The research agenda should include the most promising potential
treatments. As an example, why can't VA sponsor an initiative into stem
cell research to regenerate our damaged neurological systems,
comparable to VA's efforts with TBI and PTSD?
It is also unclear, and highly troubling, that VA has never
developed and implemented its own internal treatment-oriented strategic
research plan focused on improving the health and lives of ill Gulf War
veterans. The two RAC reports provide a clear road map for this
research direction. And, there should be a direct connection and
perpetual communication between the VA research arm and treatment
providers, with a sustained effort aimed at communicating treatment
information and ``do's and don't's'' advisements to treatment
providers.
Second, VA should be directed to provide presumptive service-
connection for all the conditions known to be caused by or strongly
associated with each Gulf War exposure, with or without IOM input.
Above all, chronic multi-symptom illness should be a presumptive
service-connection for ill Gulf War veterans. As noted earlier,
service-connection is not just a compensation mechanism; most
importantly, service-connection is the gateway to VA health care for
the service-connected conditions and veterans. VA should be directed to
increase the maximum allowable percentages for the three conditions
currently listed as presumptive under undiagnosed illness claims, which
are fibromyalgia, chronic fatigue syndrome, and irritable bowel
syndrome.
Third, VA should be directed to provide outreach to Gulf War
veterans and their loved ones, their advocates and their health care
providers about all of the Federal Government's efforts related to Gulf
War veterans.
The National Center for PTSD (NCPTSD) is an
incredible international resource and an excellent example of
what VA can do, and could serve as a model for a clearinghouse
of Gulf War illness resources and information for scientists,
health care providers, veterans, and their advocates. VA should
be directed to create such a center, including developing a
comprehensive, informative, perpetually updated Web site about
Gulf War health issues, modeled after the NCPTSD Web site.
VA needs to be directed to develop a one-page handout
on Gulf War illness listing causes, symptoms, and do's and
don'ts, modeled after VA's extraordinarily valuable pocket card
on traumatic brain injury (TBI).
VA should be directed to reestablish its now-defunct
direct-mail Gulf War Review newsletter, which was VA's only
direct communication to Gulf War veterans related to their Gulf
War service.
VA should be directed to develop and widely
disseminate information related to all ongoing research studies
related to Gulf War health issues, including studies seeking
volunteer participants.
VA should be directed to develop (or revitalize the
now defunct) clinician guide for treating Gulf War veterans
with Gulf War Illness, updating it regularly with new research
findings, promising treatments, and clinical trials.
VA should be directed to widely publicize the
existence of the Gulf War veteran brain bank, including to Gulf
War veterans, their advocates and health care providers, state
DVAs and CVSOs, and the scientific community. While it is too
late to benefit its donors, there is hope that knowledge gained
from the scientific study of the donations of their brains and
spinal cords at the time of their death will help other
veterans.
VA should be directed to reinitiate its now-defunct
Gulf War Veterans Information System (GWVIS) data reports,
which are a critical resource for veterans' service providers,
including State DVAs. VA should be directed to break out
approved undiagnosed illness claims to show actual numbers of
claims approved for general undiagnosed illness and for each
presumptive condition (of which there currently are three:
fibromyalgia; chronic fatigue syndrome; and, irritable bowel
syndrome).
Finally, VA needs to be directed and overseen to ensure that Gulf
War Illness is not the only Gulf War health outcome that is addressed.
For too long, it was thought that PTSD was the only negative brain
outcome of war; we now know that TBI is another terrible outcome of
war. And as we learn more about blast injuries, we will almost
certainly determine that such blasts also affect other body systems and
organs and not just the brain. For Gulf War veterans, VA must be
directed to focus its attention on Gulf War Illness, which affects the
largest number of ill Gulf War veterans. But, VA must not be allowed to
fail to fully address increased rates of ALS, MS, and cancers, Gulf-
related vaccination injuries (including in those who never deployed),
oil well fire smoke inhalation, raw petroleum exposures, Depleted
Uranium (DU) inhalation and ingestion, and the many more issues noted
in the RAC's November 2008 scientific report.
Thank you again for allowing me to testify. I look forward to your
questions and comments.
What follows is a statement by my mother written in 1998 in support
of my VA claim for Gulf War illness symptoms and conditions. It could
quite literally have been written by any mother of any of the 175,000-
210,000 ill veterans of the 1991 Gulf War.
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Prepared Statement of Douglas E. Dembling, Associate Chief
Officer for Program Coordination, Office of Public Health and
Environmental Hazards, Veterans Health Administration, U.S.
Department of Veterans Affairs
Good morning, Mr. Chairman, Ranking Member and Committee Members.
Thank you for this opportunity to discuss the work of the Department of
Veterans Affairs (VA) in studying the illnesses of Gulf War Veterans. I
am accompanied today by Victoria Anne Cassano, MD, MPH, Acting Chief
Consultant, Environmental Health Strategic Heathcare Group, Office of
Public Health and Environmental Hazards, and David Barrans, Deputy
Assistant General Counsel.
You have asked us to comment on VA's statements of work with the
National Academy of Sciences' (NAS) Institute of Medicine (IOM)
concerning Gulf War Veterans health issues and research. Specifically,
you asked us to address issues raised about the utilization and
consideration of animal studies by VA's Research Advisory Committee
(RAC) on Gulf War Veterans' Illnesses. My testimony will provide
background information about Gulf War Veterans, identify VA and IOM's
research findings and our actions based upon this information, review
VA and IOM agreements with regard to animal studies, describe VA's
range of services and benefits for Gulf War Veterans, and outline
Federally sponsored research related to Gulf War Veterans.
Background
The United States deployed nearly 700,000 military personnel to the
Kuwaiti Theater of Operations (KTO) during Operations Desert Shield and
Desert Storm (August 2, 1990, through July 31, 1991). Within months of
their return, some Gulf War Veterans reported various symptoms and
illnesses they believed were related to their service. Veterans, their
families, and VA subsequently became concerned about the possible
adverse health effects from various environmental exposures during
Operations Desert Shield and Desert Storm. In response, in 1994, VA
asked Congress for special authority, granted under the ``Persian Gulf
War Veterans' Act,'' Public Law 103-446, to provide compensation
benefits to Gulf War Veterans who are chronically disabled by
undiagnosed illnesses. That authority was later expanded to include
certain illnesses of unknown cause. In 1995, VA implemented the
``Persian Gulf War Veterans' Act'' by adding 38 C.F.R. Sec. 3.317,
which defines qualifying Gulf War service, establishes the presumptive
period for service connection, and denotes certain signs and symptoms
that may be manifestations of such illnesses. These signs and symptoms
include: fatigue, skin signs or symptoms including hair loss, headache,
muscle pain, joint pain; as well as neurologic, respiratory and cardiac
signs or symptoms, abnormal weight loss and menstrual disorders. In
addition, three medically unexplained multisystem illnesses' namely,
Chronic Fatigue Syndrome, Fibromyalgia and Irritable Bowel Syndrome,
are currently recognized by both statute and regulation as ``qualifying
chronic disabilities'' and thereby presumptively service connected
based on Gulf War service.
Further, through the ``Persian Gulf War Veterans Act 1998,'' Public
Law 105-277, Congress authorized VA to compensate Gulf War Veterans for
diagnosed or undiagnosed illnesses that are determined by VA to warrant
a presumption of service connection based upon a positive association
with exposure, as a result of Gulf War service, to a toxic agent, an
environmental or wartime hazard, or a preventive medication or vaccine
known or presumed to be associated with Gulf War service.
Of particular concern have been the illnesses that have eluded
specific diagnosis. The latest VA study-Health of U.S. Veterans 1991
Gulf War: A Follow-UP Survey in 10 Years (published April 2009)-found
that 25 percent more Gulf War Veterans reported suffering from
unexplained multi-symptom illness than their Gulf War era military
peers. Although the majority of Gulf War Veterans seeking VA health
care have had readily diagnosable health conditions, we remain very
concerned about Veterans whose symptoms have not been diagnosed. VA
continues to compensate and treat these conditions even without a clear
diagnosis.
VA and IOM Study Findings
As directed by Congress, VA has utilized IOM to evaluate potential
associations between environmental hazards encountered during military
deployment and specific health effects. The Agent Orange Act of 1991
(Public Law 102-4) directed VA to seek to enter into an agreement with
NAS to review and summarize the scientific evidence concerning the
association between exposure to herbicides used in support of military
operations in Vietnam during the Vietnam Era and each disease suspected
to be associated with such exposure. IOM's work has allowed VA to
recognize approximately a dozen diseases as presumed to be connected to
exposure to Agent Orange and other herbicides used during the Vietnam
War, which allows Veterans who were in theater during the relevant
period to be compensated for these conditions without having to prove
their connection to service.
In response to increased health concerns among Veterans of the 1991
Gulf War, Congress passed the Persian Gulf War Veterans Act 1998 and
again directed VA to enter into a similar agreement with NAS to review
and evaluate the available scientific evidence regarding associations
between illnesses and exposure to toxic agents, preventive medicines,
vaccines, and environmental or wartime hazards associated with Gulf War
service. This process has generated nine comprehensive IOM committee
reports on a wide variety of Gulf War health issues including
assessments of long-term health effects from vaccines, depleted
uranium, nerve agent antidotes, chemical warfare agents, pesticides,
solvents, fuels, oil-well smoke, infectious diseases, deployment-
related stress, traumatic brain injury, and Gulf War Veteran
epidemiological studies.
IOM's scientific assessments are regularly sought to address a
range of health care issues. Their independent stature and collection
of internationally recognized scholars, scientists, and researchers
uniquely positions them to provide expert, well-informed objective
findings. As Congress directed, VA contracts with IOM to obtain
independent and objective professional opinions concerning available
scientific evidence. When VA contracts with IOM, we defer to their
professional opinions concerning methodology in order to maintain this
independence. Their reports consider all available research, including
both human and animal studies, to guide their findings about whether
there is evidence of an association between exposure to a substance or
hazard and the occurrence of an illness and whether there is a
plausible biological mechanism or other evidence to support that
connection. IOM bases their recommendations upon formal findings and
scientific evidence, and their review process requires each IOM report
to be reviewed internally and externally before release to VA and the
public.
At the direction of Congress, VA, in 2002 chartered the Research
Advisory Committee on Gulf War Veterans' Illnesses to advise the
Secretary on the overall effectiveness of Federally-funded research to
answer central questions on the nature, causes, and treatments of Gulf
War Veterans' illnesses. The RAC published and released reports in 2004
and again in 2008.
After the 2008 RAC report was released, VA requested that IOM
explain discrepancies between the RAC's report and findings contained
in nine congressionally mandated IOM committee reports on Gulf War
health issues completed since 1998. On January 23, 2009, VA received a
response from Dr. Harvey Fineberg, President of the IOM, who noted:
``. . . that the RAC and the IOM committee that
prepared Gulf War and Health Volume 4: Health Effects
of Serving in the Gulf War agree that there is a
multisymptom illness in Gulf War veterans... Thus both
committees recognize increased occurrence of symptoms
in Gulf War veterans.''
``. . . The RAC attributes Gulf War illness to
pyridostigmine bromide (PB) and pesticides, whereas the
IOM committee did not link multisymptom illness to
specific exposures.''
``While the RAC and IOM committees both recognize
increased reporting of symptoms in Gulf War veterans,
the IOM committees were not able to associate specific
exposures with particular reported symptoms.''
In February 2009, Secretary Shinseki asked IOM to invite
representatives of the RAC to describe the report and the basis of its
findings to IOM to ensure that the basis for any differences between
these reports are communicated and considered by the latest IOM
committee. RAC members addressed the IOM committee at an open meeting
on April 14, 2009, in Washington, D.C. The possibility that the RAC
report reached different conclusions due to access to more recent
scientific studies cannot be ruled out. This possibility should be
answered in the current IOM full literature review on Gulf War
Veterans' health, which will be completed in February 2010.
VA and IOM Agreements Concerning Animal Studies
The major criticism by the RAC regarding the scientific process
used by the IOM committees' analyses is that IOM did not use animal
studies to draw conclusions about the strength of association between
outcome and exposure. Congress requires VA to contract with IOM for
external scientific review of the accumulating science relevant to
long-term health consequences of service in the Gulf War. IOM is an
independent, world class, scientific organization that has extensive
internal expertise and uses the world's leading external scientists for
these efforts. IOM puts all of their analyses through rigorous internal
and external review, and VA relies on their opinion and continues to
have confidence in the methods they use to conduct these assessments.
The RAC also has stated that VA inappropriately required IOM to not
use animal studies in its various analyses. In reviewing all of the
contracts for the nine IOM studies, there is no language in the Charges
to the Committee or the Statements of Work that either requires or
requests IOM to disregard animal studies. At the request of the House
Veterans' Affairs Oversight Committee, VA has provided all of the
Statements of Work for both the Gulf War IOM studies and the Agent
Orange IOM studies.
The standard procedure for all VA-contracted IOM committee studies
is to leave each independent committee completely in charge of deciding
what research to include and how to interpret it. VA relies fully upon
the IOM committee's independent scientific and medical expertise in
determining how they will use both animal and human studies in their
evaluations. VA's formal charge to each IOM committee specifically
requests they use all relevant data as they see fit.
In a January 24, 2003, letter, the Secretary of Veterans Affairs
specifically asked IOM to review animal studies on health effects from
the chemical warfare agent Sarin. This request was based on the fact
that several published studies seemed to indicate a health effect of
low-dose exposure to Sarin in animals. This request produced the 2004
IOM committee study, Gulf War & Health: Updated Literature Review of
Sarin. That IOM committee reviewed human studies as well as over 100
animal studies as cited in the report, including several studies
mentioned in the Secretary's letter on the topic. The resulting VA Task
Force report to the Secretary on this IOM report included the following
analysis on this issue:
``The Committee also reported that the newly published
data from experimental animals that had precipitated
the interest in an updated study of sarin health
effects [mentioned in Secretary Principi's letter to
IOM] which were designed to mimic the potential
exposures in the Gulf War, were an important step in
`determining whether a biologically plausible mechanism
could underlie any long-term 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.'
``The IOM committee and staff provided a briefing to
VA on August 19, 2004. At that briefing, the issue was
raised (by VA staff) that the IOM emphasis on human
studies might overlook health concerns revealed only in
laboratory animal studies. The IOM committee chair
acknowledged this concern, but also stated that the
Committee did thoroughly review available animal
studies, and concluded that taken together they failed
to show consistent biological effects that could be
plausibly tied to potential clinical effects in humans.
He added that future animal studies might change
that.''
VA's most recent charge to IOM was issued on January 27, 2009, and
included this guidance: `` . . . the goal of this exercise is to help
us understand health issues among Veterans of the 1991 Gulf War. In
carrying out your new charge, VA expects that you will make appropriate
use of all the literature your Committee considers to be relevant. That
is, we expect that your committee exclusively will be the sole
determiner on what literature must be reviewed to carry out your
charge.''
VA does not select IOM committee members, and each IOM committee is
completely at liberty to select the approach it will use in evaluating
Gulf War Veteran health issues and the scientific literature it will
use. After execution of the committee charge, VA has no contact with
committee members until a report is finalized. The entire process
normally takes 15 to 18 months.
VA Services and Benefits
Research is an important element of VA's support for Veterans, but
by turning information into action, VA directly improves the care of
America's heroes. VA trains its providers to prepare to respond to the
specific health care needs of all Veterans, including Gulf War Veterans
with difficult-to-diagnose illnesses. For Gulf War Veterans, VA
developed a Clinical Practice Guideline on post-combat deployment
health and dealing with diagnosis of unexplained pain and fatigue.
Also, VA has three War Related Illness and Injury Study Centers
(WRIISCs) to provide specialized health care for combat Veterans from
all deployments who experience difficult to diagnose or undiagnosed but
disabling illnesses. Starting in 2002, the WRIISCs began serving as
referral centers for Veterans with undiagnosed or difficult to diagnose
complaints. Veterans referred to the WRIISCs are provided with a
complete exposure assessment, outpatient or inpatient evaluation
(including advanced neurological evaluations), and a detailed treatment
plan, which is provided to the Veterans' VA primary care providers.
Based on lessons learned from the Gulf War, VA realizes that concerns
about unexplained illnesses could also emerge after Operation Enduring
Freedom and Operation Iraqi Freedom (OEF/OIF) deployments, and we are
building our understanding of such illnesses.
Following the Gulf War, VA developed the Veterans Health Initiative
(VHI) Independent Study Guides for health care providers as one of many
options to provide tailored care and support of Veterans. This Study
Guide was principally designed for the clinical care of Veterans of
that era, but has proven highly relevant for treating OEF/OIF Veterans
since many of the hazardous deployment-related exposures are likely to
be the same. VA developed other Independent Study Guides for health
care providers to deliver appropriate care to returning Veterans from
Iraq and Afghanistan that cover topics such as gender and health care,
infectious diseases of Southwest Asia, military sexual trauma, and
health effects from chemical, biological and radiological weapons.
Study Guides on post-traumatic stress disorder and TBI were also
developed and made available for primary care physicians to increase
understanding and awareness of these conditions. VHIs are currently
undergoing a comprehensive update which will both include the latest
information and make them more accessible and modifiable than in the
past. However, VHIs are only one resource for providers. Every VA
medical center is required to have an environmental health clinician
available to discuss any concerns Veterans or providers may have
regarding combat theater exposures. VA distributes similar information
to providers through newsletters, brochures, conference calls and the
WRIISCs to educate providers to the unique needs of combat Veterans.
Federally Sponsored Research
VA takes the illnesses of Gulf War Veterans very seriously and has
established a robust research program to study these illnesses. VA has
spent over $20 million in support of research on Gulf War Veterans'
illnesses in both fiscal years (FY) 2007 and 2008. VA prepares an
Annual Report to Congress that describes Federally sponsored research
on Gulf War Veterans' Illnesses, and has done so every year since 1997.
In the 2007 report, VA provided updated information on 19 research
topics in five major research areas and a complete project listing by
research focus area. The research areas include: brain and nervous
system function, environmental toxicology, immune function,
reproductive health, and symptoms and general health status. The 2007
report noted that between FY 1992 and FY 2007, VA, DoD, and the
Department of Health and Human Services (HHS) funded 345 distinct
projects related to health problems affecting Gulf War Veterans.
Funding for this research on the health care needs of Gulf War Veterans
has totaled nearly $350 million over this period of time. These
projects varied from small pilot studies to large-scale epidemiological
surveys. Nine projects were funded through the Gulf War Veterans'
Illnesses Research Program and three were funded through the Peer
Reviewed Medical Research Program. Both programs are managed by the
Congressionally Directed Medical Research Program at DoD. VA funded two
new projects in FY 2007, with one focused on Environmental Toxicology
and the other on Symptoms and General Health.
Conclusion
VA Secretaries have made full use of IOM Committee reports in
determining whether new presumptive service connections are warranted,
as provided for in the statutes that underlie this process.
Mr. Chairman, Congress has directed VA to continue to utilize IOM's
independent evaluations of research when making determinations about
Gulf War Veterans' illnesses. IOM is a nationally recognized authority
in analyzing clinical research and we rely on their ability to provide
sound assessments.
Secretary Shinseki recognizes that this well established process
takes time. He has therefore, asked VA staff to review this approach
and determine if there are additional ways to uncover the data
necessary to determine a connection between exposures in military
service and specific health outcomes.
Thank you again for the opportunity to testify. My colleagues and I
are prepared to address any questions you or the other Committee
Members might have.
Statement of Joel Kupersmith, M.D., Chief Research and
Development Officer, Office of Research and Development,
Veterans Health Administration, U.S. Department of Veterans Affairs
Thank you for the invitation to discuss the Department of Veterans
Affairs' (VA) research and development program, and specifically its
work on Gulf War Veterans' Illness. I appreciate the opportunity to
discuss the vital role VA research has in ensuring the health and well-
being of our Nation's Veterans.
My testimony will provide an overview of VA's research programs,
describe our process for allocating funding based on scientific merit,
report on our current allocation of funds for Gulf War Veterans'
Illness research, and describe some of the current challenges and
considerations associated with the science involved in this field of
study.
Overview of VA Research
For more than 80 years, VA's Office of Research and Development
(ORD) has been improving the lives of Veterans and all Americans
through health care discovery and innovation. Because more than 70
percent of VA researchers are also clinicians who provide direct
patient care, VA is uniquely positioned to move scientific discovery
from investigators' laboratories to patient care. In turn, VA
clinician-investigators identify new research questions for the
laboratory at the patient's bedside, making the research program one of
VA's most effective tools to improve the care of Veterans. Our
fundamental goals are to address the needs of the entire Veteran
population from the young recruit who returns from combat with injuries
to the aging Veteran, and to use research findings proactively to
benefit the future Veteran. Data generated by VA researchers are used
not only in current projects but also form the foundation for future
projects as well.
VA research is an intramural program that is also fully integrated
with the larger biomedical research community through VA's academic
affiliations and collaborations with other organizations. VA scientists
partner with colleagues and foster dynamic collaborations with other
Federal agencies, academic medical centers, nonprofit organizations and
private industry nationwide, further expanding the reach and scope of
VA research. This is often a channel for new and emerging technologies
to be introduced into VA; as devices or equipment are approved by the
Food and Drug Administration, VA researchers are among the first to
bring them into the mainstream clinical environment, while teaching
others how to use them.
While VA research is principally focused on benefiting current and
future Veterans, it also impacts Veteran families and caregivers, VA
health care providers, Veterans Service Organizations, other components
of the Federal research establishment, academic health centers, and
practitioners of health care across the country. VA research is a
valuable investment with remarkable and lasting returns.
Merit Review Process
VA ensures the best research programs receive funding and support
through its merit review process. A VA Office of Research and
Development (ORD) program manager with specific subject matter
expertise in the proposal's field reviews each submission and refers it
to a Peer Review Committee for evaluation. This Committee is composed
of highly qualified and senior scientists with extensive backgrounds
without conflicts of interest with the proposals they review. Each
Member critiques and scores the proposal; funding selections are made
based upon this review. If a research proposal is not selected, the
Committee's critique is provided to the researcher so that he or she
can develop a better proposal for the future.
Additionally, VA's Cooperative Studies Program (CSP) within ORD
supports research that will be ongoing for several years and involve
multiple VA medical centers and patients. To apply for CSP support,
study proponents develop a letter of intent; if this letter describes a
proposal with strong scientific and clinical significance, the letter
is then reviewed by a CSP Study planning group and the five
Coordinating Centers that would participate in the research. This group
and the Coordinating Centers work with the study proponent to further
refine the project and address logistical and scientific issues. A
separate reviewing body then considers the proposal to ensure all
potential concerns are fully addressed before the study begins.
All studies funded by ORD that involve patients receive the highest
level of scrutiny to ensure the safety of the patient and the most
certainty that the study will contribute to better health care for
Veterans.
Current Allocation of Funds for Gulf War Veterans' Illness Research
During Fiscal Year (FY) 2008, VA allocated more than $20 million
for research related to Gulf War Veteran's illnesses. This research
supports a range of programs and clinical areas, including research
into the prevalence of brain cancer among Gulf War Veterans, the
prevalence of multiple sclerosis in Gulf War Veterans, and a $15
million per year contract involving the Dallas VA Medical Center and
the University of Texas Southwestern Medical Center (UTSW) to support
Gulf War research. The UTSW research is investigating multi-symptom
illnesses among Gulf War Veterans and the contract is renewable at VA's
discretion on a year-to-year basis until September 30, 2011.
VA-funded epidemiological studies have proven instrumental in
identifying the range of chronic symptoms and health problems reported
by Gulf War Veterans. This research has found that these symptoms
occurred at rates that exceed non-deployed era Veterans and that these
symptoms persist. The most common symptoms include impaired cognition,
attention, and memory; persistent headaches; diarrhea and
gastrointestinal problems; skin rashes; extreme muscle weakness and
fatigue; joint pain; and sleep disturbances. VA continues to monitor
this population of Veterans for changes in mortality rates and
incidence of cancers. In addition to these studies of unexplained
symptoms, VA has funded investigations to assess the prevalence of
other diseases, such as cancer, amyotrophic lateral sclerosis (ALS),
and multiple sclerosis in Gulf War Veterans, since there is some
evidence that these diseases may also occur at elevated rates in this
population.
In October 2002, April 2004, and March 2005, VA issued a Request
for Applications (RFA) to solicit new research projects focused on the
long-term health effects of deployment in the Gulf War, the health
effects of specific military occupational and environmental exposures,
improvements in evaluation, diagnosis and treatment of Gulf War
Veterans' illnesses, prevalence of neurological disorders such as ALS
and multiple sclerosis in Gulf War Veterans, and changes in the
autonomic nervous system or immune system that may be associated with,
or involved in the persistence of, unexplained symptoms or illnesses
reported by Gulf War Veterans. VA recently announced a fourth RFA in
May 2009 to specifically solicit proposals to study new treatments for
ill Gulf War Veterans, including testing treatments that have
previously been used for chronic fatigue syndrome and fibromyalgia, two
conditions in the VA and general populations with similarities to Gulf
War Veterans' illnesses.
VA continues to support Gulf War Veterans research more broadly,
and over the last 15 years, VA has spent almost $130 million on
research directly related to Gulf War Veterans. These funds do not
include the VA-funded research that may be related to health care
concerns of Gulf War Veterans (i.e., ALS, multiple sclerosis, or
cancer) but are not solely focused on the Gulf War Veteran population.
The Departments of Defense and Health and Human Services have spent
more than $235 million over the same time period, for a total of almost
$365 million from the Federal Government. VA is committed to building
on what we have spent and to expand the foundation of available data to
find relief for current illnesses while planning for the future. For
example, VA is directing research into genomic studies, using state-of-
the-art imaging techniques and correlation of tests of brain function,
delineation of biomarkers, treatment trials and determinations of
autonomic and motor function.
Scientific Challenges and Considerations
VA recognizes there are challenges to establishing scientific bases
for clinical determinations about medical conditions associated with
military combat. Necessary data are sometimes unavailable, control
groups can be difficult to establish, participants may not be easily
identified, and the sheer number of potential factors or variables
renders a definitive conclusion elusive. However, our charge is to
learn as much as we possibly can about those conditions, no matter the
obstacles.
Another challenge is a perception by some Veterans that research
data will be used to make determinations regarding VA benefits. As an
assurance to Veterans, research data from participants has not been
used by VA to affect benefits and ORD supports and enforces that
policy. Similarly, VA researchers must also consider protections
established by law, regulation and policy concerning patient
confidentiality. Patient confidentiality is of utmost importance to VA
and we take extraordinary steps to protect our Veterans. The Privacy
Act and the Health Insurance Portability and Accountability Act 1996
(HIPAA) restrict how research data may be used. Patients understand
that information they provide to a researcher is personal and
potentially identifiable, and VA researchers are required to clearly
explain this to research participants.
Even very personal information, such as a research participant's
genetic structure, can be protected, and Veterans are often
enthusiastic about participating in this type of research. For example,
VA research into genomic medicine has included questions asking
participants about their feelings about this type of investigation.
More than 70 percent of Veterans surveyed reported they would
participate in genomic research; more than 80 percent of Veterans
reported believing that participation in this research would help other
Veterans; and more than 85 percent reported being curious about the
influence of their genes on their health. This support for VA's
research program provides VA with critical data and insight, and in
turn holds great potential for supporting the care and well-being of
all Veterans, including Gulf War Veterans.
Conclusion
In conclusion, VA remains committed to funding scientifically
meritorious research projects that improve our understanding of Gulf
War Veterans illnesses and enhance our ability to diagnose and treat
ill Gulf War Veterans. Moreover, the knowledge we gain from these
efforts may improve our ability to prevent and treat illnesses
affecting participants of current and future deployments. Your support
of VA's research programs is greatly appreciated and I look forward to
your questions.
Statement of Major Denise Nichols, RN, MSN, USAFR (Ret.),
Vice Chair, National Vietnam and Gulf War Veterans Coalition
The Implication of the USDVA Limited Scope of Gulf War Illness
Research:
The implication to the veterans of the Gulf War 1 (Operation Desert
Storm) to limited scope of Gulf War illness has mainly been to affect
us in the care and claim approval.
When research for one of many examples on Animal studies to not be
accepted or ruled out to be reviewed it directly affects the veterans
in their claims being approved as has occurred now for 18 years and has
caused many to have died without having received the claim approval
leaving their survivors without help. They have died feeling
abandonment by their own government that they so proudly served. The
veterans who live with the chronic deteriorating illnesses have no
relief financially and have lost totally their standard of living. They
have become demoralized and depressed due to those circumstances.
They struggle daily desperately holding on to their family or job
even when they are significantly disabled. Job hoping has occurred in
the medical people that have tried to stay employed because they want
to avoid detection of not being able to perform as they should. This
has occurred in many fields of employment. Those that turn to truck
driving have ended up having to have a wife or companion travel with
them to deal with the disorientation and potential safety hazards they
are experiencing directly connected to their health changes from the
war. Those that try the post office cannot handle a walking route or
their autonomic nervous system dysfunction cannot handle the varying
temperatures. These are just a few examples of the many I have from
dealing directly with the veterans.
I will also emphasis to you the safety factor problem that can
indirectly impact on loss of innocent civilians' lives due to this
denial. I have examples that I could detail to you in a longer
testimony.
The worse case is unemployed trying to get Social Security to
barely sustain themselves much less their family. The stresses upon
their spouses, children, and extended family are causing even more
devastating impacts on the social economic fabric of the nation that
veterans form the backbone to that strength historically.
Many have ended up homeless or finding a way to end their lives.
The health care they receive is minimal. They are being turned off
as we say in medicine because the answers, diagnostic protocols, and
treatment modalities are not there or have been considered fringe
medicine. They are turned out to Psychology Departments that know this
is not psychiatric! They get labeled psychosomatic or personality
disorders in order to turf them out medically and to avoid claim
approval. To limit time involvement, cost, and physicians retraining.
This is a huge disservice that is leaving a huge black mark in our
society and creates distrust in their government to grow within the
veteran, their families, and extend generationally.
I want to emphasis this is not a cultural sensitivity issue but a
lack of training in physicians. It is a lack of communication. It is a
lack of utilize the research and translating it to actual practice that
has been purposefully blocked by administration and institutional
denial, indifference, ineffective law enforcement, oversight, and
prosecution for failures.
It creates a moral and ethically dilemma for the health care
providers within the VA that know this is a physical condition that
they are being blocked from acknowledging to their patients. Many avoid
or limit time with Desert Storm veterans because of that. I have had a
primary care provider be in tears with me because she is so frustrated
and then to tell me her hands are tied. I have had that same primary
care provider that knows I was a highly educated and skilled nurse and
that when I brought her research articles from a peer reviewed research
journal with the names and contact information of the authors and ask
that she read it and start testing and treatment as recommend by these
doctor researchers and to start saving our lives ended up saying I am
sorry I can't and would you like a referral to psychology. Total
inappropriate response!
That is when I gave up on the VA, I would rather not have the
stress of dealing with that manner of medicine and go without anything
at all than have to do battle at that level when I am also battling for
changes as I called it at the head of the snake for myself and all
veterans of the Gulf War, who after all were and I feel still are my
patients. I tried and still do try at lower levels of the VA but it is
apparent and they have told me it is not because they want to be that
way but because their hands are tied!
So I concentrate at the top as I do with you to get clear policy
from the administration and the legislators to govern and change the
total VA in regards to the Gulf War veterans. I am part of the Gulf War
veterans that became advocates/leaders/ the loud squealers for our
fellow veterans since our return from the war. Even though many of us
are ill, the indignity and inhumane denial we and all of our comrades
have endured fuel us to keep going. Our care, health, and economic
survival (claims) has been affected by the Restrictions/policy
directives on Gulf War Illness Research placed on the IOM by the VA
Department, the Secretary of the VA in the past 18 years and by the
administration. We have also suffered by the lack of completely unified
Senate and House VA Committee hearings in a consistent and timely
manner to have through updates, status reports, oversight and
investigations on Research, Claims, and Health Care for Gulf War
Veterans.
That is why I have been since January advocating Joint Hearings on
the Senate and House VA Committee on Gulf War Illness the information
has become disjointed, unconnected, not focused. And most of all
parties are not being heard, most of all the veterans both the
advocates that have been here since 1992 and the veterans themselves.
WE have suggestions for change, we have horrifying examples that you
need to hear. WE have experts that served in key positions during the
war that have still not been heard, they need protection to come
forward. We have retaliation that has occurred that you need to hear
and address!
WE need to have these hearings on a regular ongoing basis until all
the problems are corrected. WE need new laws introduced and enacted and
enforcement of all laws for the Desert Storm Veterans.
We need truth, accountability, clear policy from every level of
government, we need change now it is past due. WE need a cleaning out
from government of those who were involved in this denial, delay, and
obstruction and interference with the truth. We need people prosecuted
in order to really affect change now and in the future. That is the
only way that we will overcome the historical legacy of the atomic
veterans, the test veterans, the Agent Orange Veterans, and us the
Desert Storm Veterans of Gulf War 1. Each generation of veterans has
said NEVER AGAIN! WE have tried to make those words real and mean
something but without you our elected officials on the hill and the
President taking that message to heart and making it happen we are
destined to repeat history errors again forever.
What the Veterans of Desert Storm Say to Have they been adequately
served? The answers come fast and frequently and they include: No, the
doctors at the VA don't even review the findings of physicals and tests
received if we go to one of the funded research studies. No, the VA
doctors still say it is stress either verbally or in non verbal means.
No, the VA does not even cooperate with the Researchers that have
funded studies to notify Gulf War veterans either thru posters or
flyers that are being offered by the researchers. No, and in their
allotted 15 minutes for an appointment they do not even have adequate
time to go thru all my past problems and my current complaints, I
always feel rushed.
No, the doctors do not seem to know about research findings that
back up our complaints. No, I asked to be put on the Gulf War Registry
and they had no idea what I was talking about. No, the doctors do not
even know some of the breaking treatments in Chronic Fatigue, Irritable
bowel syndrome, or fibromyalgia. No and I feel they don't like to
educate their patients about their own clinical tests and findings. No,
I ask them if they have had any training at all into Gulf War illness
or related illnesses and they said no. They don't want to spend much
time with us. No and I don't care if they are not military doctors or
prior experience I just wish they would know more about the related
conditions, they seem completely uninformed. No, and when I went to VA
hospital I felt totally lost and there was no one to help guide me thru
this mess. No and the clinic doctors told me they don't know what to do
for me and want me to drive 150 miles to the VA hospital. No, all they
seem to want to do is put us on pschy. drugs and not truly look into
our bodies! No and I had a heart attack before Xmas and I am glad I
went to a civilian hospital at least I am alive now. No and what is
this about a War Related Illness Center how do I get there my doctor
says he cannot help me get there!
No, the situation has not changed one bit since I went to them in
1994. No, and I still am getting denied on my claim or my claim is lost
or they are stressing me out asking for more documentation I do not
have. No and I got Social Security help more rapidly. No and they can't
seem to find my records. No and they keep wanting to push my claim as
PTSD as the priority, I guess I will take that because my family is
breaking down and I am losing everything. No and it seems we should
never even try to claim Gulf War illness because they refuse to
adjudicate those.
That is what we get in emails, chats, phone calls every day as a
Gulf War veteran and advocate! Those of us that are Gulf War veteran
advocates have manned our own suicide calls from across the Nation;
thank god they finally heard us with the new OIF/OEF veterans and
finally set up the hot line. Those of us who stepped forward to get
answers and help not just for ourselves and others feel we are still in
the war 18 years later. We wonder when the VA will ever do the right
thing. Why won't the VA listen to us when we try to be constructive and
help with the solutions?
What the Veterans and Advocates have asked:
Registries-Task Forces-Outside Civilian Agency Involvement_Independent
Oversight
WE have asked for Death registries so that veterans, family
Members, doctors, and researchers truly can see transparently what is
happening. We have asked for a Diagnosed illnesses registry to serve
the same purpose. WE have asked for local, state, and regional Desert
Storm Veteran Illness Task Forces to involve the doctors, the veterans,
and others so these issues can be addressed from the bottom up and top
down. WE have asked that CDC, Cancer Association, Heart Association,
and other associations be involved in getting data and evaluate if the
occurrences is above the normal. WE ask for some independent oversight.
Referral Centers_Centers of Excellence_Integrative Research to Clinical
Practice Centers
WE have asked for Referral centers and Centers of Excellence and
Integrative Research/Clinical Practice sites be set up with major
medical universities that have done some of the positive Gulf War
illness research.
Training of Doctors by outside Experts in Environmental Health for VA
Physicians and for the VA to Hire Environmental Health Experts
or Experts in CFS or Fee Basis to Use outside Experts
We have asked for the offers made by Environmental Physicians,
Physicians from the American Academy of Advancement in Medicine,
Physicians that see and treat civilians with CFIDS/Fibromyalgia to
train VA physicians to be accepted. We have asked that these type
doctors be recruited by VA even on part time basis to be able to see us
and treat us at the VA. All have been turned down.
TO HAVE GULF WAR VETERANS WHO ARE ILL AND HAVE BEEN ADVOCATES
NATIONALLY TO BE INVOLVED AND HEARD FULLY
WE have asked to be involved in the process to make needed change.
We have shown our willingness even if patients to take an active role
in making a difference.
I myself made an extensive presentation to the National Academy of
Science and IOM years ago laying out 26 specific suggestions that would
help, it was all like talking to the three monkey syndrome.
I have been here every step of the way every hearing on the hill,
every meeting of the PAC GWI, PSOB, many of the DoD OSI GWI townhall
meeting, almost all the VA`s RAC GWI meeting, many of the Gulf War
Veterans Advisory Committees, NAS-IOM meetings, I worked closely with
the government Oversight Subcommittee that held 3 years of hearings, I
worked going door to door briefing the Members on the hill, and
encouraging cosponsorship of each of the Gulf War veterans bills, I
have submitted my resume for each advisory Committee that was formed, I
have testified, I have brought other Gulf War veterans and their family
Members forward, I have brought researchers and doctors forward, I have
done outreach to not only veterans, family Members, doctors, but also
researchers. I have gone to medical meetings across the country to meet
doctors and researchers and interact with them. I did this not as a
glory purpose but to do all I could have since I was a nurse officer
and holding an MSN. I did it to try and work closely to resolve the
problem but as most of us that have participated a bit or more actively
we have been not welcomed. And many other Gulf War Veterans throughout
the Nation have been involved the past 19 years that could be well
utilized at the Dept. of Veterans Affairs.
Current Situation
Seems like it continues to be a chain of survivors holding on to
each other without a lot of support. So my answer like so many of the
other desert storm veterans is NO we have yet to truly pick up that
stone they always said in so many testimonies that they would not leave
unturned. AS I told Dr Joseph years ago during a vote break in one
Committee and he got rather upset. AS I said at one of the first
hearings (Senator Reigle's) we the Desert Storm veterans are a family
and a community we may have served different services and different
locations in theater but we have had to become that family and
community. We wonder where is the DoD and VA still after 18 years and
where are the Commanders that are suppose to take care of their troops
in all of this?
WE are frustrated and have developed PTSD because of this
treatment. WE are tired of being in the studies and outside lab results
to have it tossed aside and not even considered. WE are upset that some
of the doctors, researchers, and officers that had information and
shared it, that stood up for us have been paid in retaliation by
attacks on their careers. WE took oaths as we entered the service or
reenlisted and we are wondering-- have others forgotten theirs? Have
you forgotten to take care of your troops? Have you left us on the
field of battle? WE are gathering in our bunkers and sending radio
messages for evacuation and aid and it seems like the communications
still are not being received.
OUTSIDE THE BOX THINKING_INNOVATIVE
Maybe we should think outside the box and call in civilian support
as they do with the CRAF and mobilize civilian medical and have
reactivation to recall us into our units, do a recall of who is sick,
dead, triage, and start providing care to save lives. The former
military nurses and doctors, and all allied medical health care
providers that are ill will help in this process if given the
resources, etc.
WE expect an all out Manhattan project with Combined expertise
(Task forces of all related expertise) to be involved in the research
effort to get answers and to make the transition fast for any findings
to be deployed to the clinical setting. Any research done must have a
plan to disseminate the findings, educate on the findings, means to
apply it clinically in practice in an ASAP method lay out in advance of
approval of funding. This isn't just for the Gulf War veterans 1990-91
but also for national security to learn how to diagnosis, test, and
treat if this occurs again. It will also most probably help a large
part of the civilian population that suffers from CFIDS, ME,
Fibromyalgia that is costing this country greatly in economic impact in
so many ways. If we can do it for weapon production we can do it in
military medicine! If we don't the cost is much greater. Morally and
Ethically we must.
Medicine is in a different place and different breaking research
occurs faster than in the 70-1980s when we had the Agent Orange
Situation. Let us reflect on the history that has been positive in
advancements made in war time and in NASA advances that have benefited
not just the military but civilians. One example is the rapid
helicopter transport in Vietnam that is now commonplace in civilian
life. The rapid treatment of shock that has transformed medicine. So
many examples. I ask you here in Congress and in the administration to
take the lead and make a difference, it has been 18 years! I ask VA to
reexamine itself and make corrections immediately. I ask the DoD to
acknowledge they handled this poorly. I ask the President to hear us
and make a clear policy statement that leads us to a Yes WE CAN and YES
WE WILL.
MATERIAL SUBMITTED FOR THE RECORD
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 12, 2009
Lynn Goldman, M.D., MPH
Committee on Gulf War and Health
Institute of Medicine, The National Academies
500 Fifth Street, NW
Washington, DC 20001
Dear Dr. Goldman:
Thank you for your testimony at the U.S. House of Representatives
Committee on Veterans' Affairs Subcommittee on Oversight and
Investigations hearing that took place on July 30, 2009 on ``The
Implications of U.S. Department of Veterans Affairs' Limited Scope of
Gulf War Illness Research.''
Please provide answers to the following questions by Wednesday,
September 16, 2009, to Todd Chambers, Legislative Assistant to the
Subcommittee on Oversight and Investigations.
1. What criteria are used by the IOM in determining whether to
evaluate and incorporate human or animal studies in your
reports on Gulf War Illness?
2. Dr. Steele provided in her written testimony a list of
categories of research evidence relevant to the health of Gulf
War Veterans and indicated whether these categories were
included in the IOM reports or the RAC reports. A copy of this
list is provided for your review. Please explain why those
categories were not included in the IOM reports?
3. Has the IOM done an evaluation on studies relating to
chronic obstructive pulmonary disease (COPD), and what triggers
might worsen these conditions? What type of diseases associated
with service in the Persian Gulf is the IOM currently looking
at, and when will the next report be issued?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
__________
Institute of Medicine of the National Academies
Washington, DC.
October 13, 2009
Representative Harry E. Mitchell
Representative David P. Roe
Subcommittee on Oversight and Investigations
Committee on Veterans' Affairs
One Hundred Eleventh Congress
335 Cannon House Office Building
Washington, DC 20515
Dear Representatives Mitchell and Roe,
Thank you for the opportunity to clarify the statements I made in
my testimony to your Subcommittee at the hearing on July 30, 2009. I
hope that my answers to your questions will finally rectify the
inaccurate information that has been disseminated about the Institute
of Medicine Gulf War and Health reports. The answers to the questions
are below and in the attachments.
1. What criteria are used by the IOM in determining whether to
evaluate and incorporate human or animal studies in your
reports on Gulf War Illness?
First, the IOM reports are on Gulf War and Health. As mandated by
Public Laws 105-369 and 105-277, these IOM committees were tasked with
assessing the scientific literature regarding all potential health
effects that might be associated with chemical and biological agents
present in the Gulf War. While these assessments encompassed
undiagnosed illnesses, including illness that now is commonly called
Gulf War Illness, they were not specifically focused on such
conditions.
Second, the criteria used by the IOM Gulf War and Health committees
in assessing the literature are spelled out in detail in each report as
follows:
In Volume 1, Depleted Uranium, Sarin, Pyridostigmine
Bromide, and Vaccines, these criteria are explained in Chapter
3, ``Methodology''. This chapter describes the types of studies
that the Committee considered, including animal and other
nonhuman studies (pg 71), human studies (epidemiologic, pg 72;
experimental studies, pg 76; and case reports and case series,
pg 77). Review of animal studies relevant to the exposures was
included in chapters 4 ``Depleted Uranium'', 5 ``Sarin'', and 6
``Pyridostigmine Bromide''.
In Volume 2, Insecticides and Solvents, these
criteria are described in Chapter 2, ``Identifying and
Evaluating the Literature'' and in Appendix C, Identifying the
Literature, which describes the literatures search strategy and
how the voluminous information was managed. Animal studies were
used for making assessments of biologic plausibility in support
of the human epidemiologic data and were reviewed in Chapters 3
``Insecticide Toxicology'' and Chapter 4 ``Solvent
Toxicology''.
In Volume 3, Fuels, Combustion Products and
Propellants, Chapter 2, ``Considerations in Identifying and
Evaluating the Literature'' described the epidemiologic
studies, inclusion criteria, considerations in assessing the
strength of the evidence and the categories of association.
Review of relevant animal studies was included in Chapter 4
``Uncombusted Fuels and Combustion Products: Background
Information'' and Chapter 9 ``Hydrazines and nitric acid.''
Volume 4 Health Effects of Serving in the Gulf War,
assessed human studies of the prevalence of health effects seen
in Gulf War veterans, and not an assessment of health effects
associated with any particular or general exposures, the
criteria for studies is described in Chapter 3, Considerations
in Identifying and Evaluating the Literature. The task for this
Committee did not include the assessment of animal studies
since the purpose of this report was specifically to assess
studies of the prevalence of health outcomes in deployed and
nondeployed Gulf War veterans.
In Volume 5, Infectious Disease, the criteria for
including animal and human studies are described in Chapter 2.
``Methodology''. Relevant animal studies are discussed in
Chapter 5, ``Levels of Association Between Select Diseases and
Long-Term Adverse Health Outcomes''.
In Volume 6, Physiologic, Psychologic, and
Psychosocial Effects of Deployment-Related Stress, criteria for
inclusion of animal and human studies are given in Chapter 2,
``Considerations in Identifying and Evaluating the
Literature''. Relevant animal studies are reviewed in Chapter
4, ``The Stress Response''.
In Volume 7, Long-Term Consequences of Traumatic
Brain Injury, the criteria for selection of human and animal
studies are detailed in Chapter 4, ``Considerations in
Identifying and Evaluating the Literature''. Animal studies are
reviewed in Chapter 2, ``Biology of Traumatic Brain Injury''.
All documents identified from the literature searches, typically
more than one thousand to tens of thousands of citations, are reviewed
by the members of each committee. The literature searches are broad so
that all relevant (and many nonrelevant) studies are identified. The
types of literature include government reports, dissertations,
published literature in peer reviewed journals, and what is commonly
called the ``gray literature'' which includes newspaper articles,
nonpeer reviewed journals and magazines, research grants, and other
documents. The criteria for actually including a study in a particular
Gulf War and Health report varied somewhat depending on each
committee's task (for example, Volume 4 did not include animal
studies), however, all the Committees used the same criteria in their
consideration of human studies. Human studies fall into several
categories including epidemiologic studies (cohort, cross-sectional,
case reports, case series), clinical studies, occupational studies, and
accidental exposures. Each of the Gulf War and Health reports separated
human studies into 3 categories: primary, secondary, and other studies.
For a study to be considered ``primary'' it needed to:
demonstrate rigorous methods (for example, was
published in a peer-reviewed journal) and include details of
methods,
have a control or reference group,
have the statistical power to detect effects,
include reasonable adjustments for confounders,
include information regarding a persistent health
outcome, and
have a medical evaluation, conducted by a health
professional, and use laboratory testing as appropriate.
The committee did not evaluate studies of acute trauma,
rehabilitation, or transient illness (that is illness persisting for
less than 6 months). Human studies reviewed by the committee that did
not necessarily meet all the criteria of a primary study are considered
secondary studies. Secondary studies are typically not as
methodologically rigorous as primary studies and might present
subclinical findings, that is, studies of altered functioning
consistent with later development of a diagnosis but without clear
predictive value. Other studies might be case-reports, treatment
studies, etc., that contribute to the interpretation of primary and
secondary studies, but which alone would not support conclusions.
As noted above in detail, animal studies were also considered in
the Gulf War and Health reports (with the exception of Gulf War and
Health Volume 4 as that was a study of prevalence of disease in
deployed versus non-deployed forces). As stated in Volume 1 (pg 71-72):
Studies of laboratory animals and other nonhuman
systems are essential to understanding mechanisms of
action, biologic plausibility, and providing
information about possible health effects when
experimental research in humans is not ethically or
practically possible. Such studies permit a potentially
toxic agent to be introduced under conditions
controlled by the researcher--such as dose duration,
and route of exposure--to probe health effects on many
body systems. Nonhuman studies are also a valuable
complement to human studies of genetic susceptibility.
While nonhuman studies often focus on one agent at a
time, they more easily enable the study of chemical
mixtures and their potential interactions. Research on
health effects of toxic substance includes animal
studies that characterize absorption, distribution,
metabolism, elimination, and excretion. Animal studies
may examine acute (short-term) exposures or chronic
(long-term) exposures. Animal research may focus on the
mechanism of action (i.e., how the toxin exerts its
deleterious effects at the cellular and molecular
levels). Mechanism-of-action (or mechanistic) studies
encompass a range of laboratory approaches with whole
animals and in vitro systems using tissues or cells
from humans or animals. Also, structure-activity
relationships, in which comparisons are made between
the molecular structure and chemical and physical
properties of a potential toxin versus a known toxin,
are an important source of hypotheses about mechanism
of action. In carrying out its charge, the committee
used animal and other nonhuman studies in several ways,
particularly as a marker for health effects that might
be important for humans. If an agent, for example, was
absorbed and deposited in specific tissues or organs
(e.g., uranium deposition in bone and kidney), the
committee looked especially closely for possible
abnormalities at these sites in human studies. One of
the problems with animal studies, however, is the
difficulty of finding animal models to study symptoms
that relate to uniquely human attributes, such as
cognition, purposive behavior, and the perception of
pain. With the exception of fatigue, many symptoms
reported by veterans (e.g., headache, muscle or joint
pain) are difficult to study in standard
neurotoxicological tests in animals. 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.
Nevertheless, the committee did use nonhuman studies as
the basis for judgments about biologic plausibility,
which is one of the criteria for establishing
causation.
Because of the varied nature of the numerous animal studies
considered by the committee, ranging from standard toxicological
studies used for government regulation of chemicals, to mechanistic
studies of the action of a chemical on a particular organ or cell, the
Gulf War and Health committees did not establish formal criteria for
their reviews of animal studies. Nevertheless, each committee included
at least one expert toxicologist (and in many cases, several
toxicologists) who reviewed the animal/toxicity studies and these
studies were discussed by the whole committee to determine their
quality and inclusion in the reports. As with human studies, animal
studies published in peer-reviewed scientific journal were preferred
and given greater weight in coming to a conclusion regarding the
association between an exposure and a given health effect in Gulf War
veterans.
2. Dr. Steele provided in her written testimony a list of
categories of research evidence relevant to the health of Gulf
War Veterans and indicated whether these categories were
included in the IOM reports or the RAC reports. A copy of this
list is provided for your review. Please explain why those
categories were not included in the IOM reports?
Dr. Steele appears to have misinterpreted the IOM Gulf War and
Health reports. Her tables are inaccurate in the assessment of the
types of evidence used by the IOM in establishing its finding with
regards to the health of Gulf War veterans. It would not be possible to
comprehensively correct the information that she provided to you, but
on her first table (see attachment) I provide examples of the various
types of evidence she lists to illustrate that such evidence is,
contrary to her assertions, often cited in the IOM Gulf War and Health
reports. I believe it is not only important to examine which studies
were included but also the process for assessing the research in order
to reach conclusions. As noted in the response to Question 1 above, the
IOM committees have been careful to spell out in each report how they
assessed the research evidence and how they used the evidence to reach
their conclusions.
One important aspect of this process is carefully weighing the
evidence. As you might expect, not all research evidence is of the same
quality, even evidence published in peer-reviewed journals.
Furthermore, even high quality studies many not be useful for
determining an association between an exposure and a health effect;
they may have been designed to answer other questions. To objectively
weigh the evidence, all of the IOM Gulf War and Health committees have
indicated which studies were considered to be primary, that is, which
would be given the most weight based on quality and relevance. The IOM
committees also have clearly identified secondary studies that may be
supportive and can contribute to making judgments about the category of
association for a particular exposure and health effect. Because this
is an objective process, well-conducted studies that showed no
association were given as much weight as well-conducted studies that
did show an association. The committees also have tried to be extremely
accurate in their descriptions of the studies cited in the reports as
well as in the critiques of these studies. For example, when committees
disagree with the conclusions reached by the study's authors, they try
to carefully discuss the reasons for the different interpretations. In
several cases, committee members have actually discussed studies with
the authors to seek further clarification on study methods,
populations, or results to assure that interpretations of studies are
fair and accurate.
With regard to Dr. Steele's second table, she alleges that numerous
studies were not evaluated by IOM committees which, in fact, were
evaluated. I have indicated in the attachment where those studies were
cited in the various Gulf War and Health reports. I should note that
the IOM committees have also cited those reports for health effects
other than multisymptom illness, for example, in discussions of chronic
fatigue syndrome.
3. Has the IOM done an evaluation on studies relating to
chronic obstructive pulmonary disease (COPD), and what triggers
might worsen these conditions? What type of diseases associated
with service in the Persian Gulf is the IOM currently looking
at, and when will the next report be issued?
The IOM has not done a study that looks generally at COPD and its
triggers in Gulf War veterans or in other populations. However, each of
the Gulf War and Health reports has considered all health effects,
including the respiratory effects, associated with exposures to the
chemical and biological agents covered in that report. These effects
would include COPD were such data available. Most notably, the Gulf War
and Health Volume 3, Fuels, Combustion Products, and Propellants the
committee examined a number of chronic respiratory conditions--asthma,
chronic bronchitis, emphysema, and COPD.
Although the IOM and National Research Council reports have not
carried out any other COPD specific reports, COPD has been evaluated in
a number of studies, such as, the IOM Agent Orange reports, the 2004
report ``Damp Indoor Spaces and Health,'' the 4 reports in NRC series
``Research Priorities for Airborne Particulate Matter,'' the 1993 IOM
report ``Veterans at Risk: The Health Effects of Mustard Gas and
Lewisite,'' the 2002 NRC report ``Estimating the Public Health Benefits
of Proposed Air Pollution Regulations,'' the 2000 NRC report ``Waste
Incineration and Public Health,'' the 1993 NRC report ``Indoor
Allergens: Assessing and Controlling Adverse Health Effects,'' the 2000
IOM report ``Clearing the Air: Asthma and Indoor Air Exposures,'' and
the 2008 NRC report ``Estimating Mortality Risk Reduction and Economic
Benefits from Controlling Ozone Air Pollution.'' The IOM has also
published two reports on the impact of tobacco use on respiratory
health: the 2009 report ``Combating Tobacco Use in Military and Veteran
Populations'' and ``Clearing the Smoke: Assessing the Science Base for
Tobacco Harm Reduction.'' I would note that the scientific literature,
including the 2004 report of the U.S. Surgeon General, indicates that
approximately 80 percent of COPD is caused by smoking and most
exacerbations of COPD occur as a result of a respiratory infection
(Wedzicha JA and Donaldson GC. ``Exacerbations of chronic obstructive
pulmonary disease'' Respir Care. 2003 Dec;48(12):1204-13; Soto FJ and
Varkey B. ``Evidence-based approach to acute exacerbations of COPD''
Curr Opin Pulm Med. 2003 Mar;9(2):117-24).
The current Gulf War and Health committee: Health Effects of
Serving in the Gulf War, Update 2009 will be looking at all health
endpoints suggested by the literature, including multisymptom illness,
chronic fatigue syndrome, cardiovascular disease, cancer, and the other
health effects discussed in previous Gulf War and Health volumes. That
committee's report is expected to be released in March of 2010.
Once again, thank you for the opportunity to assist the Committee
on Veterans' Affairs Subcommittee on Oversight and Investigations in
its efforts to provide support for the Gulf War veterans. If I can
provide you with any further information, please do not hesitate to
contact me or the IOM.
Sincerely,
Lynn Goldman, M.D., M.P.H.
For the Committee on Gulf War and Health
Attachment
Cc: Judith Salerno, IOM
Jim Jensen, NAS
__________
ATTACHMENT
Table 1. Types of Evidence Used To Establish Findings on the Health of
Gulf War Veterans: Research Considered in IOM Gulf War Reports and the
2008 RAC Report
------------------------------------------------------------------------
Was This Type of Evidence Considered in
------------------------------- Report Findings?
Categories of Research -----------------------------------------
Evidence Relevant to the 2008 RAC
Health of Gulf War Veterans IOM Gulf War and Health Report
Reports
------------------------------------------------------------------------
Results of Peer-reviewed and
Published Scientific Studies
------------------------------------------------------------------------
Studies of Gulf War veterans
------------------------------------------------------------------------
Studies that assessed YES YES
prevalence of diagnosed
medical and psychiatric
conditions in Gulf War
veterans
------------------------------------------------------------------------
Studies that assessed (Limited) YES
prevalence of undiagnosed YES. For example, in Vol 1,
multisymptom illness in Gulf pgs 14, 246, 349-359
War veterans discuss the prevalence of
Gulf War illness in
veterans. In Vol 2,
Appendix A discusses Gulf
War illness and updates
Vol 1. All such studies
are discussed in Vol 4,
Chapters 3 and 5 (pgs 202-
213). These studies are
also discussed in Vol 6,
pages 251-254.
------------------------------------------------------------------------
Studies that assessed (Limited) YES
associations between Gulf War YES. For example, in Vol 1,
exposures and diagnosed DU pgs 150, 157-158; sarin
conditions in Gulf War pgs 196-197; PB pgs 225-
veterans 226, 245-250; vaccines pgs
285-293, 303-306. In Vol
2, associations between GW
exposure and diagnosed
conditions in GW vets are
discussed in Chapter 4 on
cancer and exposure to
insecticides, Chapter 5 on
cancer and exposure to
solvents, Chapter 7 on
neurologic effects and
diseases, including
peripheral neuropathy,
following exposure to
insecticides, and
solvents; and in sections
of Chapter 8 Reproductive
and developmental effects
and Chapter 9 additional
health effects which
includes aplastic anemia,
cardiovascular effects,
respiratory effects,
hepatic effects,
gastrointestinal effects,
renal effects, skin
conditions, and systematic
rheumatic diseases. Vol 4,
Chapter 4 discusses
numerous specific
diagnosed illnesses and
what the individual study
authors found with respect
to possible exposures of
GW veterans linked to
those health effects,
e.g., Nisenbaum et al.
2000, pg 75 and Haley and
Kurt 1997, pg 72.
------------------------------------------------------------------------
Studies that assessed No YES
associations between Gulf War YES. For example, Vol 1
exposures and undiagnosed contains a discussion of
multisymptom illness in Gulf unexplained illness in
War veterans relation to specific GW
exposures on pgs 13, 48,
50-51, 209, 303-306, 314,
350-359. Vol 2 discusses
exposures and unexplained
illness on pgs 355, 378 in
a section on multisymptom
illness on pgs 383-387.
Vol 3 contains a section
on multiple chemical
sensitivity (pgs 325-331),
unexplained illnesses, and
possible exposures that
might be responsible for
this illness in GW
veterans (pgs 328-329).
Volume 4 discusses some of
the exposures that
researchers have
identified as being
associated with
unexplained illness, e.g.,
Haley et al. 1997. In the
sarin update, sarin
exposures associated with
unexplained illness are
discussed on pgs 63, 65-
67, 69, 78, 80, 82, 84,
86, 98, but the report
does not make findings
based on those
associations as that was
not in its statement of
task.
------------------------------------------------------------------------
Studies of chemical exposures
in other human populations
------------------------------------------------------------------------
Studies that assessed YES YES
association of exposures with
diagnosed diseases
------------------------------------------------------------------------
Studies that assessed No YES
association of exposures with YES. For example in Vol 1,
undiagnosed symptomatic the section on PB contains
illness a lengthy review of
studies on a variety of
outcomes associated with
PB based on clinical
trials and epidemiologic
studies in human
populations other than GW
vets. Many of these
studies include symptoms
indicative of undiagnosed
symptomatic illness such
as neuromuscular effects
and behavior and cognitive
function in elderly
patients and those with
myasthenia gravis. As
occupational and
accidental exposures to PB
are unlikely there are no
studies of these
populations. The section
on sarin reports many long
term effects that are
similar to undiagnosed
symptomatic illness in
victims of sarin poisoning
events in Japan and in
U.S. military volunteers
prior to the GW. In Vol 2,
the committee indicates on
pg 515 that it was unable
to identify any studies
that examined the
association between
insecticide or solvent
exposure in populations
that had been exposure
free for an interval and
that presented long-term
effects as being most
likely to mimic the
exposure of GW veterans.
That committee was unable
to identify any such
studies. Vol 3 has a
discussion of multiple
chemical sensitivity,
which is related to
undiagnosed illness, in
non-GW populations on pgs
329-331.
------------------------------------------------------------------------
Studies of effects of chemical
exposures in animal models
------------------------------------------------------------------------
Studies of biological and No. YES
behavioral effects of YES. For example, animal
exposures in animals studies are discussed in
all GW&H volumes except 4,
which was a prevalence
study only. For example,
for depleted uranium,
animal studies are
discussed in Vol. 1, pgs
95-106, for sarin, there
is an entire section on
animal studies on pgs 178-
186, for pyridostigmine
bromide, pgs 211-217, for
vaccines, pgs 271-272, 275-
280, 289-291, 296-299, and
308-309. In volume 2,
there are two chapters on
the toxicology, i.e., use
of animal studies, of
insecticides (pgs 39-69)
and of solvents (pgs 82-
95). In volume 3, animal
studies are discussed on
the following pages: 35-
39, 43-49, and 351-359.
Volume 6, Chapter 4 (pgs
49-66) is about the
biology of the stress
response including animal
models.
------------------------------------------------------------------------
Studies of effects of No YES
combinations of exposures YES. For example, in Vol 1,
combinations of exposure
are discussed on pgs 217-
219 and 230. In Vol 2 on
pgs 50, 56, 62, 69. In Vol
3, on pgs 43, 252. In Vol
4, Chapter 3 on the major
cohort studies of the
prevalence of health
effects in GW veterans
discusses all the exposure
and combinations thereof
that were associated with
specific health outcomes.
------------------------------------------------------------------------
Results of Other Federally-
sponsored Gulf War Scientific
Studies
------------------------------------------------------------------------
Findings provided in project No YES
reports from DoD-funded YES. For example, among the
studies DoD-funded studies cited
in Vol 1 are: U.S. Army
1995 ``Health and
Environmental Consequences
of Depleted Uranium Use in
the U.S. Army''; USAEC
Report UR-37 ``The
excretion of hexavalent
uranium following
intravenous
administration. II.
Studies on human
studies.'' ``Multiple
animal studies for medical
chemical defense program
in soldier/patient
decontamination and drug
development on task 85-18:
Conduct of pralidoxime
chloride, atropine in
citrate buffer and
pyridostigmine bromide
pharmacokinetic studies,
and comparative evaluation
of the efficacy of
pyridostigmine plus
atropine. Final report,
June 1985-August 1988'';
``Clinical Considerations
in the Use of
Pyridostigmine Bromide as
Pretreatment for Nerve-
Agent Exposure.'' Aberdeen
Proving Ground, MD: Army
Medical Research Institute
of Chemical Defense. In
the sarin update, examples
of DoD-funded studies that
are cited include:
``Toxicity Studies on
Agents GB and GD (Phase
2): 90-Day Subchronic
Study of GB (Sarin, Type
II) in CD-Rats.'';
``Toxicity Studies on
Agents GB and GD (Phase
2): 90-Day Subchronic
Study of GB (Sarin, Type
I) in CD-Rats.'';
``Toxicity Studies on
Agents GB and GD (Phase
2): Delayed Neuropathy
Study of Sarin, Type II,
in SPF White Leghorn
Chickens.'' Throughout all
the Gulf War and Health
volumes, many DoD-funded
studies that have been
published in the peer-
reviewed literature,
particularly in the
journal Military Medicine,
are cited and have
provided critical evidence
for the committees'
findings.
------------------------------------------------------------------------
Findings presented at No YES
scientific conferences, RAC LIMITED. Although the
meetings Committee did review
abstracts of presentations
made at scientific
conferences, these
abstracts provided
background information
only and were not used in
weighing the evidence on
which the Committee based
its conclusions. Such
abstracts have not been
peer-reviewed and the data
they contain frequently
undergo revision before
being published;
therefore, the committee
considered such
information to be
preliminary only.
------------------------------------------------------------------------
Investigations, Reports on
Exposures During the Gulf War
------------------------------------------------------------------------
Reports from Federal agencies No YES
(e.g. DoD, CIA) that YES. For example, in Vol 1,
documented or modeled types, for depleted uranium, pgs
levels, and patterns of Gulf 92-94; for sarin, pgs 172-
War exposures (e.g. 174; for PB, pgs 208-209.
pesticides, oil fire smoke, In Vol 2, for
nerve agents, depleted insecticides, pgs 12-13,
uranium) particularly the 2000
``Environmental Exposure
Report-Chemical Agent
Resistant Coating'' and
the 2001 ``Environmental
Exposure Report-
Pesticides'' from the
Office of the Special
Assistant for Gulf War
Illnesses (OSAGWI). Volume
4, Chapter 2 is devoted to
exposures in the Persian
Gulf. This chapter
contains an extensive
review of the studies that
used simulation to assess
the potential magnitude of
exposure to tent heaters,
at the Khamisiyah
demolition (including a
detailed discussion of the
CIA-DoD modeling),
biologic monitoring for
depleted uranium conducted
by the VA with input from
the DoD OSAGWI, and oil-
well fire smoke monitoring
by the Army Environmental
Hygiene Agency.
------------------------------------------------------------------------
Reports from nongovernmental No YES
sources (e.g. RAND, Battelle) YES. The RAND report
that investigated and/or ``Review of the Scientific
modeled Gulf War exposures Literature as it Pertains
to Gulf War Illness'' is
cited in Vol 4 on pgs 14.
The RAND report
``Pesticide Use During the
Gulf War: A Survey of Gulf
War Veterans'' is cited in
Vol 2, pg 12. In Vol 1,
the 1999 RAND report
``Military Use of Drugs
Not Yet Approved by the
FDA for CW/BW Defense'' is
discussed on pgs 207-208,
288, the 1999 RAND report
``Depleted Uranium: A
Review of the Scientific
Literature as It Pertains
to Gulf War Illnesses'' is
discussed on pgs 91 and
97. The 1994 Battelle
report ``Dosimetry of
Large-Caliber Cartridges:
Updated Dose Rate
Calculations'' is cited on
pgs 92-93, and a 1981
Battelle
``Histopathologic,
Morphometric, and
Physiologic Investigation
of Lungs of Dogs Exposed
to Uranium-Ore Dust'' on
pgs 99-100.
------------------------------------------------------------------------
Table 2. Excess Prevalence of Multisymptom Illness in Gulf War Veterans, Compared to Nondeployed Veterans:
Studies Considered in IOM Gulf War Reports and the 2008 RAC Report
----------------------------------------------------------------------------------------------------------------
Was This Finding Included in Report?
--------------------------------------------------------------------------
Excess --------------------------------------
Number of Prevalence
Veteran Group Studied Study Gulf War in Gulf War IOM Gulf War and 2008 RAC Report
Veterans Veterans Health Reports
----------------------------------------------------------------------------------------------------------------
U.S. Air Force veterans Fukuda, 1998 1,155 30% No YES
YES. For example, in
Vol 4, pgs 74, 96,
167; Vol 6, pg 252,
254
----------------------------------------------------------------------------------------------------------------
U.K. male veterans Unwin, 1999 4,428 26% No YES
YES. For examples,
in Vol 4, pg 57, 65-
67, 81, 230; Vol 6,
pg 176
----------------------------------------------------------------------------------------------------------------
Kansas veterans Steele, 2000 1,548 26% No YES
YES. For example in
Vol 4, pg 64, 89
----------------------------------------------------------------------------------------------------------------
New England Army veterans Proctor, 2001 180 32% No YES
YES. For examples,
in Vol 4, pgs 89-
91, 163, 229; Vol
6, pg 255
----------------------------------------------------------------------------------------------------------------
U.K. female veterans Unwin, 2002 226 29% No YES
YES. For example, in
Vol 4, pg 76
----------------------------------------------------------------------------------------------------------------
U.S. national study, Phase Blanchard, 1,035 13% YES YES
III 2006
----------------------------------------------------------------------------------------------------------------
U.S. national longitudinal Kang, 2007 5,767 25% No YES
study Cannot locate a Kang
2007 reference in
the published
literature or in
the 2008 RAC
report.
----------------------------------------------------------------------------------------------------------------
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 12, 2009
James H. Binns
Chairman
Research Advisory Committee on Gulf War Veterans' Illnesses
2398 E. Camelback Road, Suite 280
Phoenix, AZ 85016
Dear Mr. Binns:
Thank you for your testimony at the U.S. House of Representatives
Committee on Veterans' Affairs Subcommittee on Oversight and
Investigations hearing that took place on July 30, 2009 on ``The
Implications of U.S. Department of Veterans Affairs' Limited Scope of
Gulf War Illness Research.''
Please provide answers to the following questions by Wednesday,
September 16, 2009, to Todd Chambers, Legislative Assistant to the
Subcommittee on Oversight and Investigations.
1. Please cite the exact section of the U.S. Code you believe
IOM and VA are violating when they are reporting on the Gulf
War studies.
2. You state in your testimony that both the RAC and IOM
Committees evaluate scientific studies relating to Gulf War
Veterans and report on their findings. Has the RAC cross-
referenced the body of work produced by the IOM against what
the RAC utilized to determine if some of the same studies have
been used by both organizations, and if so, what are those
reports?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
__________
Phoenix, AZ
December 12, 2009
Hon. Harry E. Mitchell
Chairman, Subcommittee on Oversight and Investigations
Veterans' Affairs Committee
U.S. House of Representatives
Hon. David P. Roe
Ranking Member, Subcommittee on Oversight and Investigations
Veterans' Affairs Committee
U.S. House of Representatives
Dear Chairman Mitchell and Ranking Member Roe,
I am pleased to respond to the questions in your letter regarding
my testimony at the July 30, 2009 hearing.
1. Please cite the exact section of the U.S. Code you believe
IOM and VA are violating when they are reporting on the Gulf
War studies.
Multiple sections have been violated:
38 U.S.C. Sec. 1117, note Sec. 1603(e) requires that: ``For each
agent, hazard, or medicine or vaccine and illness identified . . .
[t]he National Academy of Sciences [IOM] shall determine . . .
(A) whether a statistical association exists between
exposure to the agent . . . and the illness . . . [and]
(B) the increased risk of the illness among human or
animal populations exposed to the agent . . .''
[emphasis added]
38 U.S.C. Sec. 1118(b)(1)(B) requires that the Secretary of
Veterans Affairs shall consider ``the exposure in humans or animals''
to an agent and ``the occurrence of a diagnosed or undiagnosed illness
in humans or animals.'' [emphasis added]
Yet, as acknowledged in the first IOM Gulf War and Health report:
``For its evaluation and categorization of the degree of association
between each exposure and a human health effect, however, the [IOM]
Committee only used evidence from human studies.'' Gulf War and Health,
Volume 1, p. 72. [emphasis added] This violation of the statute has
been repeated in all subsequent reports, leaving animal studies (the
vast majority of studies on toxic substances) out of consideration. The
result is that the IOM reports have not found ``sufficient evidence of
an association.''
38 U.S.C. Sec. 1117, note Sec. 1603(c) requires the National
Academy of Sciences [IOM] to identify illnesses, ``including diagnosed
illnesses and undiagnosed illnesses,'' experienced by Armed Forces
Members who served in the war.
Yet, the second IOM Gulf War report acknowledged that the IOM
Committee was not charged with addressing ``nonspecific illnesses that
lack defined diagnoses . . . '' Gulf War and Health Volume 2, p. 13.
This violation has been repeated in other reports.
38 U.S.C. Sec. 1117, note Sec. 1605(1) defines toxic agents to
include combinations of exposures (``whether through exposure
singularly or in combination.'')
Yet, the second IOM report also acknowledged that ``exposure to
multiple agents'' was not within the Committee's charge. Gulf War and
Health Volume 2, p. 13. This violation has been repeated in other
reports.
2. You state in your testimony that both the RAC and IOM
Committees evaluate scientific studies relating to Gulf War
veterans and report on their findings. Has the RAC cross-
referenced the body of work produced by the IOM against what
the RAC utilized to determine if some of the same studies have
been used by both organizations, and if so, what are those
reports?
There is no cross-reference index. Examples of relevant studies not
cited in IOM reports are given at pages 54-55 of the 2008 Research
Advisory Committee report, Gulf War Illness and the Health of Gulf War
Veterans. An equally important problem is that the IOM reports
frequently mention studies, notably animal studies, and then fail to
consider them in their conclusions.
For example, the Updated Literature Review of Sarin report (2004)
was requested by former VA Secretary Principi expressly because of the
publication of new animal studies showing long-term health effects of
low-level Sarin exposure, and the report mentions these studies in the
body of the report. However, when it arrives at its all-important
conclusions, the report states that the Committee did not use animal
data ``as part of the weight of evidence to determine the likelihood
that an exposure to a specific agent might cause a long-term outcome.''
Updated Literature Review of Sarin (2004), p. 20.
These issues are discussed at greater length in the attached
memorandum, which I am pleased to provide as part of my response and
which includes the documents cited.
Respectfully submitted,
James Binns
Chairman
Research Advisory Committee on Gulf War Veterans Illnesses
[The attached memo and additional attachments will be retained in
the Committee files.]
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 12, 2009
Lea Steele, Ph.D.
Adjunct Associate Professor
Kansas State University School of Human Ecology
13520 Kiowa Road
Valley Falls, KS 66088
Dear Dr. Steele:
Thank you for your testimony at the U.S. House of Representatives
Committee on Veterans' Affairs Subcommittee on Oversight and
Investigations hearing that took place on July 30, 2009 on ``The
Implications of U.S. Department of Veterans Affairs' Limited Scope of
Gulf War Illness Research.''Please provide answers to the following
questions by Wednesday, September 16, 2009, to Todd Chambers,
Legislative Assistant to the Subcommittee on Oversight and
Investigations.
1. Who was it that asked that you testify on why and how
scientific findings of the Institute of Medicine (IOM)'s Gulf
War and Health reports differ from those of the Research
Advisory Committee on Gulf War Veterans' Illnesses? The title
of the hearing was ``The Implications of U.S. Department of
Veterans Affairs' Limited Scope of Gulf War Illness Research.''
Since VA is also utilizing the information provided by the RAC,
I would assume that you would be coming to discuss specifically
how the RAC report was formulated, and not create animosity
with the IOM.
2. You mention in your testimony that the RAC Committee had
several Members of the scientific community who also served on
the Institute of Medicine panels over the years. Were you one
of those Members? If not, shouldn't we be hearing directly from
one of them as to their concerns about the IOM reports? Are you
recommending that Congress to disregard the IOM reports, and
start from scratch?
3. In light of Dr. Goldman's testimony, do you still believe
that critical animal studies were eliminated from the IOM
report, and if so, could you provide for the record a detailed
list of those studies?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
__________
MEMO
FROM: Lea Steele, Ph.D.
Kansas State UniversityTO: Chairman and Ranking Member,
Subcommittee on Oversight and
Investigations, U.S. House of
Representatives Committee on
Veterans AffairsDATE: October 12, 2009RE: Responses to questions posed in
relation to testimony for the
Subcommittee's July 30, 2009,
hearing on Gulf War Illness
Research
Thank you for your interest in the work of the Congressionally
mandated Research Advisory Committee on Gulf War Veterans' Illnesses
(RAC), and for inviting my testimony related to the Committee's 2008
report on the health 1991 Gulf War veterans.\1\
My responses to questions posed in your letter received September
8, 2009, follow. If you have additional questions, please contact me by
email at Lea.Steele@hughes.net, or by telephone at: 785-945-4136.
Question 1. Who was it that asked that you testify on why and
how scientific findings of the Institute of Medicine (IOM)'s
Gulf War and Health reports differ from those of the Research
Advisory Committee on Gulf War Veterans' Illnesses? The title
of the hearing was ``The Implications of U.S. Department of
Veterans Affairs' Limited Scope of Gulf War Illness Research.''
Since VA is also utilizing the information provided by the RAC,
I would assume that you would be coming to discuss specifically
how the RAC report was formulated, and not create animosity
with the IOM.
Answer 1. I was asked by the staff of the Subcommittee on Oversight
and Investigations to testify specifically on differences between the
scientific methods and findings of the Institute of Medicine's Gulf War
and Health reports and those of the RAC. I described those differences
at the staff's request, and had no interest in creating animosity with
the IOM.
I also provided some information on the formulation and findings of
the RAC report in my testimony, as well as in my earlier testimony
before the Subcommittee in May. Additional details concerning the
formulation of the RAC report is contained in the report itself. If the
Subcommittee would like additional information either on the content of
the RAC report or the methods and approach used by the RAC, I would be
happy to refer you to those areas of the report or to answer any
additional questions you may have.
Question 2. You mention in your testimony that the RAC
Committee had several Members of the scientific community who
also served on the Institute of Medicine panels over the years.
Were you one of those members? If not, shouldn't we be hearing
directly from one of them as to their concerns about the IOM
reports? Are you recommending that Congress disregard the IOM
reports, and start from scratch?
Answer 2. A number of RAC Members have also served on a variety of
IOM Committees over the years, although I personally have not. As
stated in my testimony, the RAC, as a Committee, identified a number of
fundamental shortcomings in the approach used in the IOM Gulf War and
Health series of reports that raised concerns about the findings of
those reports. Those issues were summarized in the 2008 RAC report, and
specific examples were provided. My testimony was based on the
consensus findings of the RAC, as reflected in the 2008 Committee
report. I agree that RAC Members who have also served on IOM panels
would have been in a good position to testify on these issues, but
can't comment on why I was asked to testify and they were not. I
believe their testimony would have been similar to mine, however, had
they been asked to describe the RAC Committee's findings concerning the
IOM reports.
As indicated, the 2008 RAC report found that VA did not follow the
requirements set forth by Congress in the statute mandating the IOM
Gulf War and Health reports. The RAC specifically recommended that
those reports be redone, to adhere to Congressional directives.
Question 3. In light of Dr. Goldman's testimony, do you still
believe that critical animal studies were eliminated from the
IOM report, and if so, could you provide for the record a
detailed list of those studies?
Answer 3. Neither my testimony nor the RAC report said that
critical animal studies were eliminated from the IOM reports. Rather,
the 2008 RAC report indicated that IOM did not consider animal research
in making its determinations re: the levels of evidence relating
exposures during the Gulf War to health conditions affecting Gulf War
veterans. The RAC report actually concurred with Dr. Goldman's comments
that some animal studies had been reviewed in the IOM reports. However,
information from animal studies in the IOM reports was primarily
descriptive, and did not contribute to IOM's findings on associations
between exposures and health outcomes. There is an important difference
between a report summarizing results from animal studies and actually
using results from animal studies, along with other available research,
in forming scientific conclusions. As clearly articulated by IOM \2\
the findings of the Gulf War and Health reports were based entirely on
results of research in human populations.
As presented in detail in the RAC Report \1\ there are numerous
animal studies, many conducted in recent years, demonstrating
persistent biological effects of repeat, low-level exposure to
neurotoxic chemicals associated with military service in the 1991 Gulf
War. These include, most prominently, effects of repeat exposure to
particular types of pesticides and insect repellants, the anti-nerve
gas pill pyridostigmine bromide, and exposure to low levels of sarin
nerve gas. Additional research in animals has demonstrated synergistic
effects of combinations of these compounds, at exposure levels
comparable to those experienced by Gulf War veterans.
The IOM's limited consideration of animal studies was addressed in
detail in Mr. Binns' testimony. My own testimony focused more on other
studies and types of research--research directly relevant to the health
of Gulf War veterans, but given little or no consideration in the IOM
Gulf War and Health reports.
References
1. Research Advisory Committee on Gulf War Veterans' Illnesses.
Gulf War Illness and the Health of Gulf War Veterans: Scientific
Findings and Recommendations. Washington, D.C.: U.S. Government
Printing Office. 2008.
2. Institute of Medicine. Gulf War and Health: Volume 1--Depleted
Uranium, Pyridostigmine Bromide, Sarin, Vaccines. Washington, D.C.:
National Academy Press. 2000.
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 12, 2009
Robert W. Haley, M.D., FACE, FACP
Professor of Internal Medicine
University of Texas Southwestern Medical Center
5323 Harry Hines Boulevard
Dallas, TX 75390
Dear Dr. Haley:
Thank you for your testimony at the U.S. House of Representatives
Committee on Veterans' Affairs Subcommittee on Oversight and
Investigations hearing that took place on July 30, 2009 on ``The
Implications of U.S. Department of Veterans Affairs' Limited Scope of
Gulf War Illness Research.''
Please provide answers to the following questions by Wednesday,
September 16, 2009, to Todd Chambers, Legislative Assistant to the
Subcommittee on Oversight and Investigations.
1. It is apparent that you have a large body of work printed
in several different trade publications. However, what type of
research are you currently conducting on Gulf War illnesses,
and when will you be publishing a peer reviewed study to the VA
on the deliverables due relating to your contract of $2.5
million for the project on Gulf War Illness Research?
2. On July 15, 2009, the VA Office of Inspector General issued
a report on ``Review of Contract No. VA549-P-0027 between the
Department of Veterans Affairs and The University of Texas
Southwestern Medical Center at Dallas (UTSWMC) for Gulf War
Illness Research.'' Could you please comment on what UTSWMC
will be doing to rectify the deficiencies in the contract found
by the VA OIG?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
__________
Southwestern Medical Center
Dallas, TX.
October 13, 2009
Todd Chambers
Legislative Assistant to the
Subcommittee on Oversight and Investigations
Diane Kirkland
Printing Clerk
House Committee on Veterans' Affairs
Re: Correspondence of August 12, 2009
Dear Ms. Kirkland and Mr. Chambers:
In response to the August 12, 2009, correspondence from the
Chairman and Ranking Republican Member of the Subcommittee on Oversight
and Investigations, I submit answers to the additional questions posed
by the Subcommittee after my July 20, 2009, testimony at the U.S. House
of Representatives Committee on Veterans' Subcommittee on Oversight and
Investigations.
My research is focused solely on helping our veterans of the Gulf
War, and is showing tremendous promise in increasing our ability to
diagnose and treat Gulf War Illnesses. I appreciate the opportunity to
provide the Committee additional information regarding my research as
well as UT Southwestern's on-going efforts to comply with Contract No.
VA549-P-0027.
Please do not hesitate to contact me should you have additional
questions.
Sincerely,
Robert W. Haley, M.D., FACE, FACP
Enclosures
__________
Question 1: What type of research are you currently conducting on
Gulf War illnesses, and when will you be publishing a peer reviewed
study to the VA on the deliverables due relating to your contract of
$2.5 million [sic] for the project on Gulf War Illness Research?
Response: On the road to developing an objective diagnostic test
and treatments for VA medical centers to use in diagnosing and treating
Gulf War illness and selecting subjects for efficient clinical trials,
we undertook a carefully phased approach of validating new tests and
developing a scientific basis for treatment under VA contract funding
that would maximize the chances of success. Our approach includes five
components: 1) a 90-minute national telephone survey of 8,020 randomly
selected Gulf War-era veterans to define how many of the 700,000 Gulf
War veterans have the brain illness we described, followed by
collection of blood and DNA from 2,096 veterans for developing
treatments, 2) development of new brain MRI tests to detect the newly
described brain illness in pilot studies of over 280 research subjects,
3) validation of the new MRI brain tests in studies comparing 60 ill
and well veterans, 4) a formal ``Neuroimaging and Biomarker Study'' to
test the diagnostic effectiveness of the brain illness in 90 veterans
selected randomly from the national telephone survey, and 5) a series
of basic brain science laboratory studies to discover how pesticides
and anti-nerve agent medications given to troops damage the
intracellular machinery of brain cells to cause chronic illness and
thus how to counteract the damage with treatment. This phased approach
was designed because, developing a diagnostic test and treatment for
neurotoxic brain cell damage is an extremely difficult task, fraught
with pitfalls, and if everything is not done just right, the effort
will have no chance of succeeding.
Even though the various research projects in our program have been
funded through the contract for a relatively short time, between 9
months and 2 years, the deliverables produced for the VA have been
developed into a large body of scientific publications in a very short
time, and the pace of scientific publications will increase rapidly
over the coming year. To date, work on the Gulf War Illness Research
Program under the VA contract has resulted in 94 scientific reports,
including 9 scientific papers published in leading peer-reviewed
journals, 6 more submitted for journal peer review, 38 abstracts
published in the proceedings of scientific meetings, and 38 papers in
draft projected to be submitted to journals in the next 2-3 months. The
high ratio of scientific abstracts to full length papers is due to the
relatively short time the projects have been approved by the
contracting process; scientific innovations are usually presented first
at scientific meetings, and their abstracts published in the meeting
proceedings, before being submitted to scientific journals for
publication later.
I enclose a more detailed description of my research and a
bibliography of related abstracts and papers.
Question 2: On July 15, 2009, the VA Office of Inspector General
issued a report on `Review of Contract No. VA549-P-0027 between the
Department of Veterans Affairs and The University of Texas Southwestern
Medical Center at Dallas (UTSWMC) for Gulf War Research.' Could you
please comment on what UTSWMC will be doing to rectify the deficiencies
in the contract found by the VA OIG?
Response: UTSWMC did not seek to perform research for the VA
pursuant to a sole-source IDIQ contract and would have preferred that
the VA utilize a grant mechanism to support Dr. Haley's research.
Despite the significant problems caused by the use of the sole-source
IDIQ contract, it always has been the intent of UTSWMC to comply with
the terms of Contract No. VA549-P-0027 (the ``Contract''), as amended.
UTSWMC has been actively engaged in discussions and written
communications with the VA regarding the issues ultimately raised by
the VA OIG since April 2009, several months before the VA OIG issued
its Review of Contract VA549-P-0027. Since April 10, 2009, at least 17
written communications have passed between representatives of UTSWMC
and the VA regarding the VA's allegations of non-compliance on the part
of UTSWMC. At least two (2) face-to-face meetings between UTSWMC and VA
representatives have occurred and countless, almost daily
communications between the VA and UTSWMC contracting officers have
occurred regarding not only the issues that are the subject of Cure
Notice but also issues pertaining to the ongoing administration of the
Contract and the task orders which have now been extended via
synchronization modifications through May 31, 2010. As evidenced by the
quantity and quality of the communications between UTSWMC and the VA,
UTSWMC and the VA continue joint efforts to correct perceived
deficiencies in UTSWMC's performance of the Contract so that this most
valuable research is completed and Gulf War veterans benefit from a
greater understanding of the Gulf War related illnesses.
UTSWMC originally attempted to engage VA representatives in a
discussion regarding contractual terms which UTSWMC believed to require
UTSWMC to violate the Health Insurance Portability and Accountability
Act 1996 (``HIPAA''), the Privacy Act 1974 (Public Law No. 93-579, 5
U.S.C. Sec. 522a) (``Privacy Act''), and the Common Rule. It was
UTSWMC's good faith belief and position that the VA cannot
contractually require UTSWMC to perform illegal acts so UTSWMC's
performance of the contractual terms should be excused under the
doctrine of impossibility. The VA rejected UTSWMC's concerns regarding
the illegality of many contractual terms without comment or discussion.
Thereafter, UTSWMC has used its best efforts to respond in a diligent,
cooperative manner with the VA to bring its performance under the
Contract into compliance despite its concerns regarding the Contract's
illegality. VA Secretary Eric Shinseki's letter to the Honorable Kay
Bailey Hutchison, assuring her that the VA has no intention of using
study information to adversely affect the service-connected status or
benefits of veterans who participate in the UTSWMC studies, is
beneficial in responding to concerns expressed by potential veteran
study subjects.
UTSWMC and the VA have agreed on many of the disputed issues, and
continue to work together to achieve total compliance with the Contract
terms.
Question: What type of research are you currently conducting on
Gulf War illnesses, and when will you be publishing a peer reviewed
study to the VA on the deliverables due relating to your contract of
$2.5 million [sic] for the project on Gulf War Illness Research?
Response:
The research we are conducting on Gulf War illness at the present
time is summarized in the attached ``Roadmap'' diagram; the boxes
numbered 1-5 are the areas of research we have pursued with the funds
received through the VA contract. Even though these research programs
have been funded through the contract for a relatively short time,
between 9 months and 2 years, the deliverables produced for the VA have
been developed into a large body of scientific publications in a very
short time, and the pace of scientific publications will increase
further over the coming year. This high rate of publications is due to
the important nature of the findings obtained in the VA-funded studies.
To date, work on the Gulf War Illness Research Program under the VA
contract has resulted in 94 scientific reports, including 38 abstracts
accepted for presentation at scientific meetings, 9 scientific papers
published in leading peer-reviewed journals, 6 more submitted for
journal peer review, and 38 papers in draft projected to be submitted
to journals in the 2-3 months (see table below and attached
bibliography). This should give you the most accurate picture of the
volume and nature of the research findings we have published and will
be publishing in the near future.
Scientific papers and abstracts from the Gulf War Illness Research Program under VA contract funding
--------------------------------------------------------------------------------------------------------------------------------------------------------
Full Length Scientific Papers Abstracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitted/in Under Submitted/ Under
Phase Published peer review development Published in review development Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Pilot studies to refine and validate new 6 6 22 32 66
brain imaging tests in normal subjects
--------------------------------------------------------------------------------------------------------------------------------------------------------
2 Pilot ability of brain imaging tests to 12 3 2 17
detect brain differences in ill vs well
Gulf War veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
3 Neuroimaging/ Biomarker Study in national 0
sample of Gulf War veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
4 National Survey of Gulf War veterans and 1 1 2
Serum-DNA Bank
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 Basic neuroscience studies of chemical 3 3 3 9
damage in brain cells to develop treatments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 9 6 38 38 0 3 94
--------------------------------------------------------------------------------------------------------------------------------------------------------
The high ratio of scientific abstracts to full length papers is due
to the relatively short time the projects have been approved by the
contracting process; scientific innovations are usually presented at
scientific meetings, and their abstracts published in the meeting
proceedings, before being submitted to scientific journals for
publication later. The abstracts and papers, a list of which is
attached, can be categorized by the phases of the research program in
which they were generated (see the list of publications and the Roadmap
attached).
On the road to developing an objective diagnostic test for VA
medical centers to use in diagnosing Gulf War illness and selecting
subjects for efficient clinical trials (see Roadmap), we undertook a
carefully phased approach of validating the tests under VA contract
funding that would maximize the chances of success. Our Overall
Research Plan, which guided all work proposals submitted to the
contract process, included two sequential VA-funded pilot studies, the
first designed to tune the complex tests on normal volunteers (#1 on
the Roadmap) and the second to ensure they are working in detecting
subtle brain damage in a battalion studied over 12 years and thus known
to have the illness (#2), before moving to the final validation study
in a population-representative sample of Gulf War veterans selected
randomly from our national survey of Gulf War veterans (#3). This
phased approach was designed because, developing a diagnostic test for
neurotoxic brain cell damage is an extremely difficult task, fraught
with pitfalls, and if everything is not done just right, the effort
will have no chance to succeed.
1. Pilot Studies to refine new MRI diagnostic tests in normal
volunteers (October 2007--June 2008)
After developing cutting-edge brain imaging tests to detect subtle
differences in brain function over the past decade under DoD funding,
with the VA contract funding we first performed a large number of short
validation studies to refine the complex brain function tests and
ensure that they are measuring the specific brain functions and
pathways intended. Each test had a dedicated team of researchers
pursuing it, and as the pilot studies were completed, they submitted
scientific abstracts for the methods and findings to the leading
scientific conferences, where they went through the peer review process
for selecting meeting presentations. Following presentation at the
scientific meetings where they receive peer review comments and
criticisms from fellow scientists, the researchers compose full length
scientific papers on the findings for submission to scientific
journals.
This effort was incrementally funded to begin between October 2007
and June 2008. Despite the fact that it has been in operation for less
than 2 years, it successfully developed and validated a new battery of
brain function tests capable of detecting the subtle brain damage
caused by chemical neurotoxicity. To date, work on the these
developmental pilot studies under the VA contract has resulted in 66
scientific reports, including 32 abstracts accepted for presentation at
scientific meetings, 6 scientific papers published in leading peer-
reviewed journals, 6 more submitted for journal peer review, and 22
papers in advanced draft ready to be submitted to journals in the next
couple months (see table above and attached bibliography).
2. Pilot the new MRI tests to detect brain function differences
underlying symptoms in a restudy of ill vs well veterans.
Once the tuning of the cutting-edge tests in normal volunteers was
completed in June 2008, we proceeded to the next phase to apply the
tests to a more formal pilot study. For this study we assembled the 23
tests that passed the first pilot phase into a battery that could be
administered in according to a tight daily time schedule over a 6-day
period. After testing and refining the logistics of running two
subjects at a time through the battery schedule, over a 12-month period
we ran the battery on 57 Members of a Seabees battalion representing
both ill and well Gulf War veterans first studied 10 years previously.
The purpose was to see whether the tests actually detect the subtle
differences in brain function between the ill and well veterans
responsible for the symptoms.
This more formal pilot study, begun in late July 2008 and completed
on July 3, 2009, found that all but one of the cutting-edge MRI tests
successfully detected the expected subtle differences in brain function
underlying the symptoms. Our teams of researchers are presently
preparing abstracts for scientific meetings and manuscripts for journal
publication. To date, work on the these developmental pilot studies
under the VA contract has resulted in 17 scientific reports, including
3 abstracts accepted for presentation at scientific meetings, and 12
scientific papers in advanced draft ready to be submitted to journals
in the next 2-3 months (see table above and attached bibliography).
3. Neuroimaging and Biomarker Study
The third phase for developing diagnostic tests of Gulf War illness
involves a definitive validation of the cutting-edge MRI tests
comparing ill and well Gulf War veterans selected randomly from the
entire population of Gulf War veterans (#3 in the Roadmap; also see the
National Survey in the next section). This phase began in August 2009,
and will be completed by June 1, 2010. Consequently no abstracts or
papers have yet resulted from this phase.
4. The Full National Survey and Serum/DNA Bank
To estimate how many Gulf War veterans have the multisymptom
illness and provide the random sample for the Neuroimaging and
Biomarker Study (see section 3 above), we conducted a computer-assisted
telephone interview survey of 8,020 randomly selected Gulf War veterans
(#4 on the Roadmap). It began in April 2007 and was completed in June
2009. During the interviews, all ill veterans and a random sample of
well veterans were asked to contribute a blood sample to a Serum and
DNA Bank. The collection of 2,096 blood samples for the Serum/DNA Bank
was completed at the end of August 2009. The final reports for these
two phases have been completed for submission to the VA contracting
office shortly, a scientific paper describing the methods of the survey
has been drafted and is under review and revision internally, and the
definitive tests for the Gulf War gene, discovered by our prior DoD-
funded studies, will be completed by the end of November 2009. An
abstract presenting the statistical innovations for the survey was
accepted for presentation at a national statistical meeting.
5. Studies of Damage in Brain Cells
At present no treatment has been found to relieve the symptoms of
chemical brain damage in Gulf War veterans. The road to developing
treatment requires generating knowledge from basic neuroscience
research to understand how the Gulf War-associated chemicals damaged
the internal machinery of brain cells to produce the permanent
symptoms. This is usually a many-year undertaking, so to shortcut the
required time to discover such mechanisms, we have 10 basic
neuroscience laboratories testing the most likely mechanisms in mice
exposed to pesticides and pyridostigmine, anti-nerve agent medication
given to our troops (#5 in the Roadmap). These studies comprised the
last component of the program to be funded by the VA contracting
process; these studies began between October and December 2008. These
studies, however, have already borne considerable promising findings on
the mechanisms involved in chemical damage to brain cells. To date,
this work has produced 3 abstracts accepted for scientific meeting
presentations, 3 full length scientific papers published in leading
peer-reviewed journals, and 3 more papers under development. Additional
publications will take shape as more results come out over the next 3
months.
[GRAPHIC] [TIFF OMITTED] T1878A.004
__________
Bibliography of Abstracts and Papers
1. Pilot Studies to refine new diagnostic tests in normal
volunteers (July 2008 to June 2009)
Papers Published in Scientific Journals
1. Ferree, T., Brier, M., Hart, J., Kraut, M. Space-time
frequency analysis of EEG data using within-subject statistical
tests followed by sequential PCA. Neuroimage 45(1):109-21,
2009.
2. Gholipour A, Kehtarnavaz N, Gopinath K, Briggs R. Cross-
Validation of Deformable Registration With Field Maps in
Functional Magnetic Resonance Brain Imaging. IEEE Journal of
Selected Topics in Signal Processing, Special issue on fMRI
Analysis for Human Brain Mapping, 2008, 2:854-869.
3. Zaremba AA, Macfarlane DL, Tseng WC, Stark AJ, Briggs RW,
Gopinath KS, Cheshkov S, White KD. Optical head tracking for
functional magnetic resonance imaging using structured light. J
Opt Soc Am A Opt Image Sci Vis. 2008, 25:1551-7.
4. A. Gholipour, N. Kehtarnavaz, R. Briggs, K. Gopinath, W.
Ringe, A. Whittemore, S. Cheshkov, K. Bakhadirov. Validation of
brain functional EPI to anatomical MRI registration. IEEE
Transactions on Biomedical Engineering 2008, 55:563-71.
5. Carmack PS, Schucany WR, Spence JS, Gunst RF, Lin Q, and
Haley RW. (2009). Far Casting Cross Validation. Journal of
Computational and Graphical Statistics, 18 (Paper accepted and
in press.)
6. Motes M. A., Rypma B. Working memory component processes:
Isolating BOLD signal-changes. NeuroImage (Paper accepted and
in press.)
Papers Submitted or Near Submission to Scientific Journals
7. Hart J, Calley, C, Brier M, Spence J, Ferree T, Abdi H,
Cormack P, Tillman G, Anand R, Motes M, Maguire M, Briggs R,
Freeman T, Kraut M. Semantic threat feature organization in
visual object memory: fMRI BOLD and electrophysiological
response. (Manuscript submitted for journal peer review).
8. Matthew R Brier, Jeffrey S Spence, Thomas C Ferree.
Accommodating within-subject and across-subject variance in
group studies of event-related spectral perturbations. Human
Brain Mapping 2009 (Manuscript submitted for journal peer
review).
9. Sina Aslan, Feng Xu, Peiying L. Wang, Jinsoo Uh, Uma S.
Yezhuvath, Matthias van Osch, and Hanzhang Lu. Estimation of
labeling efficiency in pseudo-continuous arterial spin
labeling. Magnetic Resonance in Medicine 2009 (Manuscript
submitted for peer review).
10. Koen, J.D., Odegard, T.N., Cooper, C.M., Jenkins, K.M., &
Bartlett, J.C. Posterior hippocampal activity during encoding
predicts subsequent recall of associative information.
Hippocampus (Manuscript submitted for journal peer review).
11. Cooper, C.M., Farris, E.A., Koen, J.D., Bartlett, J.C. &
Odegard, T.N. Role of an inferior parietal and hippocampal
network in episodic retrieval. Cognitive Neuroscience
(Manuscript submitted for journal peer review).
12. Tatebe, K., Spence, J.S., Ferree, T.C. Statistical test
for canonical coherence: analytic derivation using moments.
IEEE Trans. Signal Proc. 2009(Manuscript submitted for journal
peer review).
13. Audrey Chang, Sergey Cheshkov, and Richard Briggs.
Reproducibility of proton MR T2 relaxation
measurements in human basal ganglia at 3T. (Manuscript to be
submitted for journal peer review by November, 2009).
14. Ringe WK, Gopinath KS, Carter KS, Onuegbulem CC, Briggs R
W. Demonstration of the Functional Connectivity of the Ventral
and Dorsal Striatum using Functional Connectivity Magnetic
Resonance Imaging. (Manuscript to be submitted for journal peer
review by November, 2009).
15. Spence, J.S., Carmack, P.S., Gunst, R.F., Schucany, W.R.,
Lin, Q., and Haley, R.W., Nugget estimation for a class of
nonparametric semivariograms using regularization, (Manuscript
in preparation).
16. Carmack, P.S., Spence, J.S., Schucany, W.R., Gunst, R.F.,
Lin, Q., and Haley, R.W. On a class of nonparametric
semivariogram and nugget estimators, (Manuscript in
preparation).
17. Spence, J.S., Carmack, P.S., Lin, Q., Gunst, R.F.,
Schucany, W.R., A spatial analysis of functional neuroimaging
data: extensions to fMRI BOLD, (Manuscript in preparation).
18. Spence, J.S., Carmack, P.S., Lin, Q., Gunst, R.F.,
Schucany, W.R. Multiple uses of kriging in functional
neuroimaging, (Manuscript in preparation).
19. Spence, J.S., Carmack, P.S., Gunst, R.F., Schucany, W.R.
Sub-space FDR (Manuscript in preparation).
20. Delzell, D.A.P., Lin, Q., Gunst, R.F., Schucany, W.R.,
Woodward, W.A. Carmack, P.S., Spence, J.S., and Haley, R.W.
Design-induced cyclic effects in event-related fMRI
experiments, (Manuscript in preparation).
21. Gedif, K., Schucany, W.R., Woodward, W.A., Carmack, P.S.,
and Haley, R.W. (2009). ``Detecting Brain Activations in
Functional Magnetic Resonance Imaging (fMRI) Experiments with a
Maximum Cross-Correlation Statistic,'' (Manuscript in
preparation).
22. Delzell, D.A., Gunst, R.F., Schucany, W.R., Woodward,
W.A., Carmack, P.S., Lin, Q., Spence, J.S., and Haley, R.W.
(2009). Selection of interstimulus intervals for event-related
fMRI experiments. (Manuscript in preparation).
23. Li X, Sarkar S, Buhner DM, Haley RW, Briggs RW. ASL
Optimization studies for observing physotigmine modulation
effects on hippocampus perfusion. (Manuscript in development;
estimated submission date to Journal of Cerebral Blood Flow and
Metabolism, October 2009).
24. Li X, Sarkar S, Haley RW, Briggs RW. Modulated dual
saturation pulse trains for fair studies of cerebellum
perfusion. (Manuscript in development; estimated submission
date to Magnetic Resonance in Medicine, November 2009).
25. Li X, Spence J, Buhner DM, Haley RW, Briggs RW. Dynamic
evaluation of hippocampus perfusion response to physostigmine
using OPTIMAL FAIR. (Manuscript in development; estimated
submission date to Journal of Cerebral Blood Flow and
Metabolism, December 2009).
26. Li X, Sarkar S, Haley RW, Briggs RW. Asymmetric FAIR.
(Manuscript in development; estimated submission date to
Magnetic Resonance in Medicine, December 2009).
27. K Gopinath, W Ringe, A Goyal, R Briggs. Functional
connectivity networks exhibit dependencies on FcMRI baseline
conditions. (Manuscript to be submitted for peer review by mid-
October 2009).
28. W Ringe, K Gopinath, A Goyal, K Carter, C Onuegbulem, R
Briggs. Functional connectivity networks associated with dorsal
and ventral striatum (Manuscript to be submitted for peer
review by mid-October 2009).
Published Abstracts of Results Presented at Scientific Meetings
29. A. Chang, S. Cheshkov, S. Sarkar, and R. Briggs.
Reproducibility of Cerebral Metabolite 1H T2 Relaxation
Measurements at 3T. Proc. Intl. Soc. Mag. Reson. Med. 16; 2008:
1600.
30. H-M. Baek, S. Cheshkov, A. J. Chang, and R. W. Briggs.
Quantification of Short-TE metabolite signals in human brain
using QUEST and a simulated basis set. Proc. Intl. Soc. Mag.
Reson. Med. 17; 2009: 4278
31. S. Aslan, J. Uh, P. Mihalakos, B. Thomas, C. Tamminga, and
H. Lu. Regional CBV characteristics in normal subjects and its
relation to CBF: a VASO and ASL MRI study. Proc. Intl. Soc.
Mag. Reson. Med. 16; 2008; 1922.
32. S. Aslan, F. Xu, P. L. Wang, J. Uh, U. Yezhuvath, M. van
Osch, and H. Lu. Labeling efficiency is critical in pseudo-
continuous ASL. Proc. Intl. Soc. Mag. Reson. Med. 17; 2009:
621.
33. X. Li, S. Sarkar, D. M. Buhner, R. W. Haley, and R. W.
Briggs. ASL optimization for hippocampus physostigmine
challenge perfusion study. Proc. Intl. Soc. Mag. Reson. Med.
17; 2009: 1516.
34. X. Li, S. Sarkar, R. W. Haley, and R. W. Briggs. Modulated
dual saturation pulse trains for fair studies of cerebellum
perfusion. Proc. Intl. Soc. Mag. Reson. Med. 17; 2009:1517.
35. Goyal, W. Ringe, K. Gopinath, L. Jiang, R. Haley, and R.
Briggs. Functional connectivity to dorsal and ventral striatum
exhibit different dependencies on FcMRI baseline conditions.
Proc. Intl. Soc. Mag. Reson. Med. 17; 2009: 3730-1.
36. Goyal, W. Ringe, K. Gopinath, R. Haley, and R. Briggs.
Functional connectivity networks associated with dorsal and
ventral striatum. Proc. Intl. Soc. Mag. Reson. Med. 17; 2009:
3727-8.
37. Thomas C Ferree, Matthew R Brier, John Hart Jr, Michael A.
Kraut. Space-time-frequency analysis of EEG data in semantic
memory. Cognitive Neuroscience Meeting, March 21-24, 2009, San
Francisco, CA
38. Thomas C. Ferree, Matthew R. Brier, Mandy J. Maguire,
Jeffrey S. Spence. Space-time-frequency analysis of EEG data in
semantic inhibition: Control of false positives in single
subjects. Organization for Human Brain Mapping, June 18-22,
2009, San Francisco, CA
39. Spence, JS., Carmack, PS., Lin, Q., Gunst, RF., Schucany,
WR. Nugget estimation for class of nonparametric
semivariograms. Joint Statistical Meetings 2008 Abstract
#302624
40. Carmack, PS., Spence, JS., Lin, Q., Schucany, WR., Gunst,
RF. Far Casting cross validation. Joint Statistical Meetings
2008 Abstract #302597.
41. O'Hair, J.C., Gunst, R.F., Schucany, W.R., Woodward, W.A.
Extraction of the hemodynamic response function and parameter
estimation for the two gamma difference model. 2009
International Biometric Society, Eastern North American Region
Spring Meetings, San Antonio, TX
42. Koh, O.J, Schucany, W.R., Woodward, W.A., Gunst, R.F.
Wavelet packet resampling for fMRI experiments. 2009
International Biometric Society, Eastern North American Region
Spring Meetings, March 15-18, 2009, San Antonio, TX.
43. O'Hair, J.C., Woodward, W.A., Gunst, R.F., Schucany, W.R.
Signal Extraction in Noisy Images: Improvements to Wavelet-
Based False Discovery Rate Methods. 2009 Joint Statistical
Meetings, Washington, D.C.
44. Koh, O.J, Schucany, W.R., Woodward, W.A., Gunst, R.F.,
``The Effects of Dimension in Wavelet Resampling on Tests for
Functional Connectivity,'' 2009 Joint Statistical Meetings,
Washington, D.C.
45. W. Ringe, K. Gopinath, S. Cheshkov, S. Sarkar, R. Briggs,
and R. Haley. High resolution functional MRI imaging of
material-specific encoding in the head, body and tail of the
hippocampus. Proc. Intl. Soc. Mag. Reson. Med. 16; 2008: 549.
46. W. Ringe, K. Gopinath, S. Cheshkov, S. Sarkar, R. Briggs,
and R. Haley. High resolution functional MRI imaging of
material-specific visual processing in thalamic nuclei. Proc.
Intl. Soc. Mag. Reson. Med. 16; 2008: 159.
47. W. K. Ringe, K. Gopinath, S. Cheshkov, S. Sarkar, R.
Briggs, and R. Haley, High Resolution Functional MRI Imaging of
Material-Specific Encoding in the Head, Body and Tail of the
Hippocampus, Proc. Intl. Soc. Mag. Res. Med. 16, abstract 549
(2007). 15th ISMRM (International Society for Magnetic
Resonance in Medicine) meeting, Berlin, Germany, May 3-9, 2008.
48. W. K. Ringe, K. Gopinath, S. Cheshkov, S. Sarkar, R.
Briggs, and R. Haley, ``High Resolution Functional MRI Imaging
of Material-Specific Visual Processing in Thalamic Nuclei'',
Proc. Intl. Soc. Mag. Res. Med. 16, abstract 159 (2007). 15th
ISMRM (International Society for Magnetic Resonance in
Medicine) meeting, Berlin, Germany, May 3-9, 2008.
49. Hart J., Calley C, Tillman G, Green T, Motes M, Kirk A,
Kraut M Threat: featural organization to visual object memory.
Society for Neuroscience, November 16, 2008.
50. Motes MA, Biswal, B, Rypma B. Age-related differences in
the mediation of cognitive processing speed by prefrontal
cortex. Presented at the 38th Annual Meeting of the Society for
Neuroscience, November 2008.
51. Maciejewski M., Byrapureddy R., Motes M., Rypma B.
Individual differences in the time course of processing speed-
neural activity relations. Cognitive Neuroscience Society, 2009
Annual Meeting, San Francisco, CA, March 2009.
52. Maciejewski M., Motes, M., Rypma B. Time course analysis
of individual differences in prefrontal BOLD activity:
processing-speed mediation of cognitive control. Society for
Neuroscience, Chicago, IL, October 2009.
53. Cooper, C.M., Farris, E.A., Koen, J.D., Bartlett, J., &
Odegard, T.N. Role of the left hippocampus and left inferior
parietal network in successful recollection of names. Paper
presented at the 21st Annual Convention of the Association for
Psychological Science, San Francisco, CA, 2009
54. Koen J.D., Cooper C.M., Jenkins K.M., Bartlett J., Odegard
T.N. The Neural Correlates at Encoding That Predict Cued-Recall
of Associative Information Paper presented at the 21st Annual
Convention of the Association for Psychological Science, 2009,
San Francisco, CA.
55. Yousefi S, Kehtarnavaz N., Gholipour A., Gopinath K.,
Briggs R. Comparison of registration methods for atlas-based
segmentation of subcortical structures in magnetic resonance
brain images. ICASSP 2010.
56. Yousefi S, Kehtarnavaz N, Gopinath K, Briggs R. Two-stage
registration of substructures in magnetic resonance brain
imaging. ICIP2009: 16th IEEE Int. Conf. on Image Processing,
Egypt, 2009 (in press).
57. Gholipour A, Kehtarnavaz N, Gopinath K, Briggs R, Panahi
I. Average Field Map Image Template for Echo-Planar Image
Analysis. 20th Annual International Conf Proc IEEE Eng Med Biol
Soc. 2008;2008:94-7. ConferenceVancouver, British Columbia,
Canada, August 20-24, 2008.
58. Tsang O, Gholipour A, Kehtarnavaz N, Gopinath K, Briggs R,
Panahi I. Comparison of tissue segmentation algorithms in
neuroimage analysis software tools. 30th Annual International
IEEE EMBS ConferenceVancouver, British Columbia, Canada, August
20-24, 2008.
59. Gholipour S, Kehtarnavaz N, Gopinath K, Briggs R. Cross-
Validation of Deformable Registration With Field Maps in
Functional Magnetic Resonance Brain Imaging. IEEE Journal of
Selected Topics In Signal Processing, Vol. 2, No. 6, December
2008.
60. Yousefi S., Kehtarnavaz N., Gopinath K., Briggs R. Two-
stage registration of substructures in magneti resonance brain
images. ICIP 2009.
2. Pilot the ability of the new tests to detect brain function
differences underlying symptoms in ill vs well veterans (July
2008 to June 2009)
Papers Published in Scientific Journals
Papers Submitted or Near Submission to Scientific Journals
61. Tillman GD, Green TA, Ferree TC, Calley CS, Maguire MJ,
Briggs R, Hart J Jr, Haley RW, Kraut MA. Impaired response
inhibition in ill Gulf War veterans. (Manuscript to be
submitted for journal peer review by September 20, 2009)
62. Calley CS, Buhl V, Tillman GD, Green TA, Hart J Jr, Haley
RW, Kraut MA. Impaired word finding in ill Gulf War veterans.
(Manuscript under revision, to be submitted for publication by
December 2009.)
63. Gopinath K, Briggs R, Gandhi P, Goyal A, Fang Y, Jiang L,
Ouyang L, Buhner D, Haley R. Quantitative sensory testing fMRI:
differences between Gulf War syndrome patients and deployed
controls (Manuscript to be submitted for peer review by mid-
November 2009).
64. Gopinath K, Jiang L, Ouyang L, Gandhi P, Goyal A, Fang Y,
Ringe W, Briggs R. Differences in functional connectivity
between Gulf War veterans and deployed controls assessed with
BOLD fMRI. (Manuscript to be submitted for peer review by end-
November 2009.
65. Tillman GD, Green TA, Ferree TC, Calley CS, Maguire MJ,
Hart J Jr., Haley RW, MA Kraut. Atypical ERP response to
threatening stimuli in ill Gulf War veterans. (Manuscript under
revision, to be submitted for publication by December 2009).
66. Ferree TC, Tatebe K, Bhat J, Sinton CM.
Electroencephalographic differences in veterans of the 1991
Persian Gulf War. (Manuscript in preparation).
67. Ringe W, Gopinath K, Whittemore A., Woolston D., Cullum
M., Biggs M., Posamentiere M., Onuegbulem C., Carter K., Briggs
R., Haley R. Abnormal cavities in the vestigial hippocampal
sulcus in veterans with Gulf War illness. (Manuscript to be
submitted for journal peer review by November, 2009).
68. Cheshkov S, Chang A, Baek H, Ganji S, Briggs R, Haley R.
Persistent basal ganglia NAA/Cr ratio differences in Gulf War
Syndrome. (Manuscript in development; estimated submission date
November 2009).
69. Li X, Buhner DM, Briggs RW, Haley RW. ASL MRI of
hippocampus perfusion responses to physostigmine challenge of
Gulf War veterans. (Manuscript in development; estimated
submission date to Radiology, November 2009).
70. Odegard TN, Cooper CM., Farris EA, Arduengo J, Bartlett
JC, Haley RW. Impaired memory in ill Gulf War veterans.
(Manuscript to be submitted for journal peer review by
December, 2009).
71. Odegard TN, Cooper CM, Farris EA, Arduengo J, Bartlett JC,
Haley RW. Differences in brain activation during memory
encoding between ill-Gulf War veterans and deployed controls.
(Manuscript to be submitted for journal peer review by
December, 2009).
72. Odegard TN, Cooper CM, Farris EA, Arduengo J, Bartlett JC,
Haley RW. Differences in brain activation during memory
retrieval between ill-Gulf War veterans and deployed controls.
(Manuscript to be submitted for journal peer review by
December, 2009).
Published Abstracts of Results Presented at Scientific Meetings
73. Cheshkov S, Chang A, Baek H, Briggs R, and Haley RW. Basal
Ganglia NAA/Cr ratio in Gulf War Syndrome at 3T. Proc. Intl.
Soc. Mag. Reson. Med. 17; 2009; 1126.
74. L Jiang, P Gandhi, M Qui, A Goyal, Y Fang, L Ouyang, K.
Gopinath, W Ringe, R. Haley, and R. Briggs. Functional
Connectivity Differences to ventral putamen of Gulf War
syndrome II and control subjects. Proc. Intl. Soc. Mag. Res.
Med. 17, abstract 1212 (2009).
75. R McColl, S Li, R Briggs, R Haley. Diffuse White matter
differences between Gulf War syndrome II and control subjects
revealed by diffusion tensor MRI. Human Brain Mapping 2009:
abstract no. 1317.
Abstracts of Results to be Submitted to Scientific Meetings
76. Calley CS, Buhl V, Tillman GD, Green TA, Hart, J Jr.,
Haley RW, Kraut MA. Impaired word finding in ill Gulf War
veterans. To be submitted as an abstract to the Cognitive
Neuroscience Society.
77. Tillman GD, Green TA, Ferree TC, Calley CS, Maguire MJ,
Hart, J Jr., Haley RW, Kraut MA. Impaired response inhibition
in ill Gulf War veterans. To be submitted as an abstract to the
Cognitive Neuroscience Society.
3. Neuroimaging and Biomarker Study (August 2009 to June 2010)
This phase has just begun, and so peer-reviewed abstracts and
papers are approximately 9-12 months away.
4. The Full National Survey and Serum/DNA Bank (April 2007 to August
2009)
This phase just ended at the end of August 2009. The final report
will be delivered to VA by the end of September. One abstract has been
presented at a national meeting, and a scientific paper has been
drafted and is undergoing revision.
Papers Published in Scientific Journals
Papers Submitted or Near Submission to Scientific Journals
78. Vincent G. Iannacchione, Jill A. Dever, Kathleen A.
Considine, Darryl Creel, Christopher P. Carson, Heather Best,
Carla M. Bann, and Robert W. Haley. The U.S. Military Health
Survey: A population-based multi-disciplinary study of Gulf War
syndrome. (Manuscript under revision with expected submission
in November 2009).
Published Abstracts of Results Presented at Scientific Meetings
79. Vincent G. Iannacchione, Darryl Creel. Sequential modeling
for contact and cooperation propensity for the United States
Military Health Survey. Joint Statistical Meetings. August,
2009.
5. Studies of Chemical Damage in Brain Cells (October 2008 to December
2009)
Papers Published in Scientific Journals
80. Sidiropoulou K, Lu FM, Fowler MA, Xiao R, Phillips C,
Ozkan ED, Zhu MX, White FJ, Cooper DC. Dopamine modulates an
mGluR5-mediated depolarization underlying prefrontal persistent
activity. Nature Neuroscience 2009; 12 (2): 190-199.
81. Hawasli AH, Koovakkattu D, Hayashi K, Anderson AE, Powell
CM, Sinton CM, Bibb JA, Cooper DC. Regulation of hippocampal
and behavioral excitability by Cyclin-dependent kinase 5. PLOS
ONE 2009; 4(e5808): 1-13.
82. Xu J, Kurup P, Zhang Y, Goebel-Goody SM, Wu PH, Hawasli
AH, Baum ML, Bibb JA, Lombro PJ. Extrasynaptic NMDA receptors
couple preferentially to excitotoxicity via calpain-mediated
cleavage of STEP. The Journal of Neuroscience 2009;
29(29):9330-9343.
Papers Submitted or Near Submission to Scientific Journals
83. Marvin M, Ding X, Casey B, Goldberg MS. Altered brain
neurotransmitter levels and metabolism in mice exposed to
chlorpyrifos and pyridostigmine bromide: Implications for Gulf
War illness. (Manuscript to be submitted for journal peer
review by December, 2009).
84. Wu J, Bezprozvanny I. Gulf War Illness implicated
chemicals sensitize neurons to glutamate excitotoxicity.
(Manuscript to be submitted for journal peer review by December
2009).
85. Mashimo T, Vemireddy V, Sirasanagandla S, Nannepaga S,
Yang S, Bachoo R. Organophosphate, Diisopropylflurophosphate
(DFP) exposure can transactivate oncogenic pathways, stimulate
proliferation of astrocytes and stem/progenitor cells and
induce diffuse gliosis in a murine model. (Manuscript to be
submitted for journal peer review by December, 2009).
Published Abstracts of Results Presented at Scientific Meetings
86. Speed H, Blaiss C, Powell C. Chronic exposure of adult
mice to the pesticide, chlorpyrifos, results in enhanced
emotional memory and altered hippocampal synaptic transmission.
Society for Neuroscience Annual Meeting. October 2009.
(Abstract selected as one of the top 10 of the international
meeting to be promoted to the news media.)
87. Wang Z, Vernino S. Acute and prolonged effects of
pyridostigmine on autonomic ganglionic synaptic transmission in
mouse. Autonomic Neuroscience 2009; 149: 90.
88. Puttaparthi K, Luther C, and Elliott JL. The role of AChE
inhibitors in ALS. Society for Neuroscience Meeting 2009.
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 12, 2009
Roberta F. White, Ph.D.
Professor and Chair, Associate Dean of Research
Department of Environmental Health
Boston University School of Public Health
Talbot Building 4W, 715 Albany Street
Boston, MA 02118
Dear Dr. White:
Thank you for your testimony at the U.S. House of Representatives
Committee on Veterans' Affairs Subcommittee on Oversight and
Investigations hearing that took place on July 30, 2009 on ``The
Implications of U.S. Department of Veterans Affairs' Limited Scope of
Gulf War Illness Research.''
Please provide answers to the following questions by Wednesday,
September 16, 2009, to Todd Chambers, Legislative Assistant to the
Subcommittee on Oversight and Investigations.
1. Are your studies being included in the body of work
evaluated by the IOM and the RAC?
2. The research you are doing on evaluating Gulf War veterans
who may have been exposed to various toxins is interesting.
When do you expect to publish your results?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
__________
Boston University
School of Public Health
Boston, MA.
October 13, 2009
Harry E. Mitchell, Chairman
David P. Roe, Ranking Republican Member
Subcommittee on Oversight and Investigations
Committee on Veterans' Affairs
U.S. House of Representatives
335 Cannon House Office Building
Washington, D.C. 20515
Dear Congressmen Mitchell and Roe:
I am happy to address the two questions that you have sent me
regarding the testimony that I prepared for the Subcommittee's meeting
on Gulf war illness on July 30, 2009.
1. Are your studies being included in the body of work evaluated
by the IOM and the RAC?
Most of the research was included in the RAC report that was
published in November of 2008. I do not know if any of the work is
being considered by the present IOM Committee.
2. The research you are doing on evaluating Gulf War veterans who
may have been exposed to various toxins is interesting. When do you
expect to publish your results?
The work on toxicants has been published and is included in the
list of papers that I sent when I responded to the questions from my
May, 2009, testimony (letter dated July 1, 2009).
Please contact me if there are any further questions, and thank you
for your interest in our work.
Sincerely,
Roberta F. White, PhD, ABPP/cn
Associate Dean for Research
Professor and Chair, Department of Environmental Health
Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
Washington, DC.
August 31, 2009
Honorable Eric K. Shinseki
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20420
Dear Secretary Shinseki:
Thank you for the testimony of Douglas E. Dembling, Associate Chief
Officer for Program Coordination, Office of Public Health and
Environmental Hazards, Veterans Health Administration, U.S. Department
of Veterans Affairs, accompanied by Victoria Cassano, M.D., MPH, Acting
Chief Consultant, Environmental Health Strategic Health Care Group,
Veterans Health Administration, U.S. Department of Veterans Affairs,
Joel Kupersmith, M.D., Chief Research and Development Officer, Veterans
Health Administration, U.S. Department of Veterans Affairs, and David
Barrans, Deputy Assistant General Counsel, Office of General Counsel,
U.S. Department of Veterans Affairs at the U.S. House of
Representatives Committee on Veterans' Affairs Subcommittee on
Oversight and Investigations hearing that took place on July 30, 2009
on ``The Implications of U.S. Department of Veterans Affairs' Limited
Scope of Gulf War Illness Research.''
Please provide answers to the following questions by 12:00 p.m.,
Wednesday, October 1, 2009, to Todd Chambers, Legislative Assistant to
the Subcommittee on Oversight and Investigations.
1. Please elaborate on the differences between the RAC Report
2008 and IOMs finding. How does the VA plan to mediate the
differences of the two reports and how will this affect our
veterans?
2. Please elaborate on the recommendations that the Task
Force made to the Secretary regarding the IOM reports from the
Gulf War and the recommendations that the Task Force made
regarding the RAC findings for the 2008 Report.
3. Please explain how the VA plans to alter the perceptions
of Gulf War Veterans who believe that the VA provides Gulf War
veterans nothing but procedural excuses when it comes to care,
treatment and answers that the feel there has been little done
to treat, acknowledge and explain veterans' illnesses. How are
Gulf War Veterans to believe their sacrifices and service are
recognized by the VA, VBA and the caregivers in the VAMCs?
4. From your response given to us, please explain how and why
ORD chose to organize their budget allocating only $7 million
to Gulf War Research (with the exception of the $15 million
specifically earmarked to UTSW), $16.9 million to TBI and $22.9
million to PTSD. Does the VA feel that this disparity is just
and that there is enough Gulf War Research on-going at this
time to provide answers for how these veterans became sick and
on-going studies for treatment?
5. Please explain how benefits are awarded to those with
multi-symptom or undiagnosed illness from the Gulf War? Please
describe at length the number of claims that are requested and
awarded vs. requested and denied with Gulf War veterans. Please
report the number of symptoms related to Gulf War Veterans that
are granted as service connected as compared to the number of
symptoms that are denied for Gulf War veterans?
6. What is the percentage of denial of claims of Gulf War
veterans as compared to the population at large that applies
for benefits through the VA? Are Gulf War veterans denied at a
greater rate than any other war?
7. After listening to the first panel explain the differences
in their reports, could you please provide a step by step
process by which the VA evaluates the reports once they are
received from both the IOM and the RAC, and explain any
differences in the mandate for each of these reports.
8. Is the material provided to you by both the RAC and the
IOM sufficient to meet the research needs of the Gulf War
veterans being treated at the VA? What has VA done beyond
evaluating the RAC and the IOM reports to further research on
Gulf War veterans?
9. What areas of Gulf War Illnesses is VA funding research?
When do you expect to see the results of these studies?
10. How much weight does VA place on IOM and RAC reports when
determining presumptions for service-connected disabilities for
the purposes of benefits and health care? Does VA ever make
determinations of service-connection for disabilities without
the use of IOM and RAC reports? Please explain.
11. How recently was the Veterans Health Initiative (VHI)
Independent Study Guide for treating 1991 Gulf War veterans
updated? Do you have a copy of that study guide which you can
provide to the Committee?
Thank you again for taking the time to answer these questions. The
Committee looks forward to receiving your answers. If you have any
questions concerning these questions, please contact Subcommittee on
Oversight and Investigations Majority Staff Director, Martin Herbert,
at (202) 225-3569 or the Subcommittee Minority Staff Director, Arthur
Wu, at (202) 225-3527.
Sincerely,
Harry E. Mitchell
Chairman
David P. Roe
Ranking Republican Member
MH/tc
Questions for the Record
Hon. Harry E. Mitchell, Chairman
Hon. David P. Roe, Ranking Member
House Committee on Veterans' Affairs
Subcommittee on Oversight and Investigations
The Implications of U.S. Department of Veterans Affairs
Limited Scope of Gulf War Illness Research
July 30, 2009
Question 1: Please elaborate on the differences between the RAC
Report 2008 and IOM's finding. How does the VA plan to mediate the
differences of the two reports and how will this affect our Veterans?
Response: The major difference between the Institute of Medicine's
(IOM) findings and the Research Advisory Committee (RAC) report is that
the RAC ascribes symptoms of unexplained illnesses to the combined
effects of pyridostigmine bromide and pesticides. The IOM, based on a
review of peer-reviewed literature regarding undiagnosed/unexplained
illnesses, concluded that the relevant scientific literature did not
lead to a conclusion of such a specific cause and effect relationship
based both on biologic plausibility and epidemiology. In February 2009,
the Department of Veterans Affairs (VA) asked the IOM to address the
differences in the two reports. While the IOM does not intend to
specifically review the RAC report (since they only review primary
research and not reviews of research), in early 2010, when the next IOM
update is published, we expect that they will comment on the peer-
reviewed scientific literature that may be cited in the RAC report,
which meets the IOM's criteria for inclusion in its reviews.
Furthermore, we have requested, and received from IOM, a proposal to
specifically review the literature regarding the possible relationship
between the use of pyridostigmine bromide tablets and exposure to
pesticides and the development of unexplained and or undiagnosed
illness in Gulf War Veterans. We are planning on having this topic be
the subject of the IOM's next biennial update on Gulf War Veterans
health.
Question 2: Please elaborate on the recommendations that the Task
Force made to the Secretary regarding the IOM reports from the Gulf War
and the recommendations that the Task Force made regarding the RAC
findings for the 2008 Report.
Response: VA follows the statutory process for responding to the
IOM reports. The Task Force was established to enable the Secretary to
meet the specific statutory requirements for responding to reports of
the IOM, and has not made recommendations based on the recent RAC
report. In response to the last GW Veterans' illnesses update, VA
determined that it would establish presumptions of service-connection
for nine infectious diseases and their long term sequelae for Veterans
suffering from these sequelae.
Question 3: Please explain how the VA plans to alter the
perceptions of Gulf War Veterans who believe that the VA provides Gulf
War Veterans nothing but procedural excuses when it comes to care,
treatment and answers that they feel there has been little done to
treat, acknowledge and explain Veterans' illnesses. How are Gulf War
Veterans to believe their sacrifices and service are recognized by the
VA, VBA and the caregivers in the VAMCs?
Response: After the July 30, 2009 hearing, VA subject matter
experts in research and development, environmental hazards, and
benefits met with Members of the RAC to better ascertain the
initiatives needed to improve services, care, and the perceptions about
that care for GW Veterans. VA determined that meeting the basic matrix
is already present to provide GW Veterans with excellent care despite
the fact that their conditions remain undiagnosed. A Secretary level
Work Group was formed in September 2009 to continue to forge the future
directions of VA in support of these Veterans. The main focus of these
efforts is treatment-oriented research, training of VA clinicians and
benefits administrators regarding the conditions that are currently
presumptively service-connected, and exposure related disease in
general. Veterans Health Administration (VHA) has already initiated an
overhaul of the Veterans Health Initiatives that are continuing medical
education programs for providers.
The Work Group is focusing on:
Defining all key areas of review (e.g., research;
Veterans' access to services; treatment, claims service,
policy, outreach, VA organizational and process relationships,
and training of clinical staff);
Consulting key experts and relevant stakeholders and
reviewing relevant reports (e.g., the Institute of Medicine; VA
advisory committees, and research experts);
Capturing the issues, data, as well as program and
performance information (e.g., complaints, claims statistics,
treatment modalities, funding, and service gaps);
Looking holistically at issues and opportunities to
advocate for the Veteran (e.g., ways to deliver better and
faster service and ways to expand programs); and
Identifying, as a priority, initiatives that enhance
identification and treatment of GW Veterans' unexplained and
undiagnosed illnesses.
Question 4: From your response given to us, please explain how and
why ORD chose to organize their budget allocating only $7 million to
Gulf War Research (with the exception of the $15 million specifically
earmarked to UTSW), $16.9 million to TBI and $22.9 million to PTSD.
Does the VA feel that this disparity is just and that there is enough
Gulf War Research on-going at this time to provide answers for how
these Veterans became sick and on-going studies for treatment?
Response: Office of Research and Development (ORD) planned budget
allocation in Fiscal Year (FY) 2008 was to spend an additional $7
million on Gulf War Veterans Illnesses (GWVI) above the $15 million
earmarked for the contract with The University of Texas Southwestern
(UTSW) for its Gulf War Research Project, for a total GWVI allocation
of $22 million. The premise behind UTSW's research is that exposure to
insecticide and nerve gas agents is a primary cause of GWVI, and a
major focus of that research was brain imaging and blood tests designed
to identify Veterans suffering from GWVI. VA supported this approach
and was very hopeful that the research would provide a path forward in
developing tests to help diagnose GWVI. In particular, the brain
imaging studies held promise because they might show differences
between afflicted and non-afflicted Veterans, no matter what the true
cause or causes of GWVI might be. Accordingly, VA considered the
contract studies to be a key component of its GWVI research effort.
But, because most scientists studying GWVI do not believe the cause of
GWVI has been solved, VA funded an additional $7 million in GWVI to
look at additional possible causes as well as diverse research
strategies that might provide other paths forward to developing future
treatments.
Finding one or more safe and effective treatments for GWVI is
critically important to suffering Veterans as well as VA. By investing
an additional $7 million research funds in diverse strategies for
diagnosis and treatment beyond those investigated by UTSW, VA is hoping
to accelerate the research breakthroughs needed to begin the process of
translating research findings into clinical support and treatment.
As such, VA never considered the UTSW contract to be a separate
effort, but rather a significant component in VA's GWVI research
program. The overall GWVI budget was determined with due regard to
avoiding potentially wasteful duplication of the work underway as part
of the UTSW contract.
VA is committed to funding research that might shed light on the
cause(s) of GWVI and promising approaches to diagnosis and (eventually)
treatment for Veterans suffering from GWVI. Funding for GWVI must
necessarily be balanced against important studies related to other
conditions faced by Veterans of the Gulf War, Veterans in other
conflicts, and non-conflict related health conditions in Veterans
resulting from military service. For example, Veterans who served in
Vietnam and who were exposed to Agent Orange suffer from a variety of
medical conditions which have been presumptively service connected,
including peripheral neuropathy, leukemia, diabetes mellitus, Hodgkin
disease, non-Hodgkin lymphoma, prostate cancer and respiratory cancer.
Other diseases, such as osteoporosis, have been presumptively service
connected for some former prisoners of war. Veterans of all eras suffer
from disabling mental health issues including schizophrenia,
depression, and post-traumatic stress disorder (PTSD). In addition to
the somewhat narrowly defined GWVI portfolio, Gulf War Veterans may
have highly prevalent mental health post-deployment disorders such as
PTSD that ORD also supports at an appropriate level. At a minimum the
funding for mental health research also relevant to Gulf War Veterans
includes $22.9 million for PTSD; $5.9 million for mood disorders such
as depression, and $12 million for addictive disorders in FY08. Current
Veterans have particularly high rates of polytrauma and funding levels
reflect allocation of those resources that have been provided by
Congress to address this wide spectrum of conditions. These funding
levels are determined largely as the result of competitive application
from VA clinician-investigators who treat these conditions, and thus
reflect the balance of disease being treated by VA.
Question 5: Please explain how benefits are awarded to those with
multi-symptom or undiagnosed illness from Gulf War? Please describe at
length the number of claims that are requested and awarded vs.
requested and denied with Gulf War veterans. Please report the number
of symptoms related to Gulf War Veterans that are granted as service
connected as compared to the number of symptoms that are denied for
Gulf War veterans?
Response: Service-connected disability benefits may be awarded on
the basis of direct incurrence in service, aggravation of a pre-service
disability, or on the basis of presumption, if there is no evidence of
the disability during service. 38 U.S.C. Sec. 1117, implemented by 38
CFR 3.317, establishes presumptions of service connection for chronic
undiagnosed illness or medically unexplained chronic multisymptom
illness, such as chronic fatigue syndrome, fibromyalgia and irritable
bowel syndrome, that first manifested during service or to a degree of
10 percent or more during an established period following service in
the Southwest Asia Theater of Operations (SWA).
The Veteran need only establish, through competent medical or lay
evidence, the presence of chronic disabling symptoms lasting 6 months
or more, that exhibit objective indicators or signs, and that can not
be attributed to any known clinical diagnosis (except for chronic
fatigue syndrome, fibromyalgia and irritable bowel syndrome).
Regarding Gulf War Veterans' claims for chronic undiagnosed illness
or medically unexplained chronic multi-symptom illness such as chronic
fatigue syndrome, fibromyalgia and irritable bowel syndrome, VBA
processed 38,359 claims as of September 30, 2009. Of these, 15,181 were
granted service connection for at least one undiagnosed condition, and
23,178 were denied service connection for any undiagnosed condition.
Question 6: What is the percentage of denial of claims of Gulf War
veterans as compared to the population at large that applies for
benefits through the VA? Are Gulf War veterans denied at a greater rate
than any other war?
Response: VA does not have the historical information necessary to
respond to this question. We do have information for recent claims and
for Veterans currently receiving VA compensation benefits. The data
provided below was obtained from Compensation and Pension records that
are currently active and does not include Veterans who received no
grant of any service-connected disability or who have subsequently
died. The data provided identifies the number of Veterans from each
identified wartime period who have at least one service-connected
disability or those who have no service-connected disability.
For 300,000 Veterans of Operation Desert Shield/Storm
with claims decisions, 85.7 percent were granted service
connection for at least one condition, and 14.3 percent were
not granted service connection for any condition.
For over one million Veterans with in-country Vietnam
service with claims decisions, 85.3 percent were granted
service connection for at least one condition, and 14.7 percent
were not granted service connection for any condition.
For over 500,000 Global War on Terror (GWOT) Veterans
with claims decisions, 83.5 percent have been granted service
connection for at least one condition, and 16.5 percent were
not granted service connection for any condition. The 500,000
GWOT claims came from Veterans with service after 9/11. The
300,000 claims noted above were from Veterans deployed to
Desert Shield/Storm. These counts are for distinct periods of
service, and Veterans who served in both may be included in
both counts.
Question 7: After listening to the first panel explain the
differences in their reports, could you please provide a step by step
process by which the VA evaluates the reports once they are received
from both the IOM and the RAC, and explain any differences in the
mandate for each of these reports.
Response: The Agent Orange Act 1991, Pub. L. No. 102-4 (codified in
part at 38 U.S.C. Sec. 1116) and the Persian Gulf War Veterans Act of
1998, Pub. L. No. 105-277, title XVI (codified in part at 38 U.S.C.
Sec. 1118), direct the Secretary of Veterans Affairs to contract with
the National Academy of Sciences (NAS) to evaluate the available
evidence concerning the health effects of exposure to herbicides and
exposure to certain hazards suspected to be associated with Gulf War
service and to prepare biennial reports to the Secretary summarizing
its findings based on such evidence. Pursuant to those statutes, NAS's
Institute of Medicine (IOM) prepares such reports and provides them to
the Secretary.
The process by which VA evaluates the IOM reports in order to
assist the Secretary in making determinations is described below:
RECEIPTS OF REPORT AND IOM COMMITTEE BRIEFING
VA receives a draft copy of the IOM report about 1 week prior to
the date of the report's public release. On the day of public release,
a representative of the IOM Committee provides VA a briefing on the
report. The briefing identifies any significant findings in the report,
any changes in the IOM's categorization of specific diseases in
comparison to prior reports, and any significant changes, and responds
to any questions from VA participants. The briefing is attended by the
Members of VA's Working Group (described below) and other interested VA
personnel.
SUMMARY OF VA'S REVIEW PROCESS
VA has not adopted formal procedures governing its internal review
of IOM reports under the two statutes discussed above. However,
practice has been it involves a three-tiered review. In the first tier,
a ``Working Group'' of VA employees from different operational elements
of VA reviews the IOM report and any other relevant evidence and
prepares a summary of its assessment and a statement of recommendations
or options. This summary is intended for the benefit of a ``Task
Force'' composed of high-level VA officials. In the second tier, the
Task Force, based on the Working Group's input, provides
recommendations to the Secretary, usually in the form of a separate
written report. In the third tier, the Secretary determines, based on
the Task Force's input, whether a presumption of service connection is
warranted for any disease.
VA WORKING GROUP
The Working Group ordinarily consists of Members of the Office of
Public Health and Environmental Hazards (OPHEH) of VHA, the
Compensation and Pension Service (C&P Service) of the Veterans Benefits
Administration (VBA), and representatives from the Office of the
General Counsel (OGC). Additionally, the Working Group often includes
other VHA personnel with specialized medical training or experience
concerning a health issue implicated by a particular IOM report.
Members are assigned to the Working Group by supervisory personnel
within VHA, VBA, and OGC.
The Working Group convenes after receiving the briefing from the
IOM committee. Prior to the meeting, VHA personnel seek to identify
based on the IOM report and the Committee briefing, the diseases that
may warrant special consideration because the IOM's findings with
respect to those diseases appear to be potentially significant. At the
initial Working Group meeting, VHA provides the Working Group Members
with additional information concerning those diseases, including copies
of any significant scientific studies identified in the IOM report and
other information concerning matters such as the course of the disease,
known causes or risk factors, related conditions or health effects,
latency periods (if any), and any other known relevant information.
OGC representative briefs the Working Group on the legal standard
governing the Secretary's decision. Members of the Working Group
discuss whether any of the IOM's findings appear to be potentially
significant, in that they might warrant a presumption of service
connection for a particular disease or diseases, and will discuss the
strength of the scientific evidence with respect to such diseases. The
Working Group will attempt to reach consensus as to whether the
scientific evidence appears to warrant a presumption of service
connection for any diseases under the applicable legal standard. If the
Working Group reaches agreement that a presumption is or is not
warranted on the basis of the scientific evidence and the legal
standard, it will agree to put forth a recommendation based on that
conclusion. In arriving at such recommendations, the Working Group
relies on scientific evidence and the legal standard, and does not
consider matters of governmental policy or cost.
If the Working Group concludes that the scientific evidence and
legal standard do not provide a clear basis for recommending for or
against establishing a presumption, but permit a range of options, the
Working Group agrees to set forth a range of options for decision by VA
policymaking officials. In those circumstances, the Working Group will
discuss the factors that preclude a clear recommendation, which may
include ambiguity in the governing statutory standard as applied to
certain IOM findings, the limited or conditional nature of the IOM's
findings with respect to certain diseases, or other factors. The
Working Group will discuss the decisional options available to the
Secretary and may also discuss the factors that may be relevant to the
Secretary's decision among those options. To this extent, the Working
Group may discuss the policy considerations that would be relevant to
the Secretary's choice among permissible courses of action.
Once the Working Group has reached agreement concerning its
recommendations or presentation of options, a written report is
completed. The Report will contain (1) a summary of the issues to be
decided under applicable law and the IOM report, (2) a summary of the
findings contained in the IOM report, (3) a summary of the legal
standard governing VA's decision, (4) a summary of the Working Group's
analysis of the medical evidence in relation to the legal standard,
particularly with respect to any potentially significant findings in
the IOM report, and (5) a statement of the Working Group's
recommendations or of the options identified by the Working Group. The
Working Group does not prepare or obtain a cost estimate for the
options, although it may provide general information concerning, e.g.,
the prevalence rates of certain diseases under consideration. If the
Working Group report lists a range of options available to the
Secretary, it would identify the scientific and legal considerations
relevant to the Secretary's choice among those options, and may also
identify policy implications associated with various options.
VA TASK FORCE
The Task Force consists of the Under Secretary for Health, the
Under Secretary for Benefits, the General Counsel, and the Assistant
Secretary for Policy and Planning. There is no established procedure
for the Task Force's deliberations. Task Force Members receive a copy
of the Working Group report and, based on that report, provide advice
to the Secretary concerning the Secretary's determination, which may
include recommendations based upon the options, if any, outlined by the
Working Group. The Task Force often, though not always, provides a
separate report to the Secretary.
SECRETARY
Based on the Task Force's report, the Secretary determines whether
or not to establish presumptions for any diseases discussed in the IOM
report and directs appropriate action to implement the decision.
VA Charter: Research Advisory Committee:
At the direction of Congress, VA in 2002 chartered the VA Research
Advisory Committee on Gulf War Veterans' Illnesses (RACGWVI) to advise
the Secretary on the overall effectiveness of Federally funded research
to answer central questions on the nature, causes, and treatments of
Gulf War-associated illnesses. The RACGWVI's charter stipulates they
are to provide information and recommendations to VA. Despite this
limited charge, the RACGWVI published and released an independent
report, including recommendations, in 2004 and again in 2008.
Question 8: Is the material provided to you by both the RAC and the
IOM sufficient to meet the research needs of the Gulf War Veterans
being treated at the VA? What has VA done beyond evaluating the RAC and
the IOM reports to further research on Gulf War Veterans?
Response: Although the RAC and the IOM provide valuable advice in
developing the VA research program, development and execution of
meaningful research projects relies upon the skill and clinical
experience of VA investigators who individually and collectively help
develop specifics of the research agenda. Seventy percent of VA
researchers are also clinicians who treat Veterans. This allows
clinicians to develop research projects in response to the symptoms
their patients exhibit including Gulf War Illnesses.
Additionally, in an effort to generate more Gulf War Illness-
related research proposals, VA's Office of Research and Development
(ORD) has issued the following Requests for Applications (RFA):
Oct 2002--Deployment Health Research RFA issued (ongoing for
all Merit Review cycles)
. . . research focused on potential long-term health effects
of exposures and risk factors among Veterans of hazardous
deployments, such as the Gulf War, Project SHAD, Bosnia/Kosovo,
or Afghanistan. . . . ORD recognizes five major research
categories related to deployment health as priorities:
Long-term health impacts of hazardous
deployments
Health impacts of specific military
occupational and environmental exposures
Improvements in evaluation and diagnosis of
deployment-related illnesses
Improvements in treatment of deployment-
related illnesses
Health risk communication for Veterans and
health care providers.
Apr 2004--1st Gulf War Research RFA (14 of 54 proposals
funded)
. . . for studies directly relevant to Veterans who were
deployed during the 1990's to the Persian Gulf.--research
studies that focus on potential long-term health effects of
exposures and risk factors among Veterans of the Gulf War in
several areas of interest. . . . We are particularly interested
in studies in the following areas:
Immunological changes (activation,
suppression, interactions) that may be associated with
the unexplained illnesses reported by Gulf War Veterans
Autonomic system changes that may be
associated with symptoms reported by Gulf War Veterans
The prevalence of neurological disorders in
Gulf War Veterans
Proposals that address other important
objectives regarding causes, mechanisms, and treatments
for Gulf War Veterans' illnesses.
March 2005--2nd Gulf War Research RFA (12 of 44 proposals
funded)
. . . ORD will fund relevant and scientifically meritorious .
. . research studies that focus on potential long-term health
effects of exposures and risk factors among Veterans of the
Gulf War in several areas of interest. . . . proposals related
exclusively to PTSD or stress-related conditions will not be
funded under this program announcement. . . . Research
priorities include:
Long-term health effects of hazardous
deployments
Health effects of specific military
occupational and environmental exposures
Improvements in evaluation and diagnosis of
Gulf War Veterans' illnesses
Improvements in treatment of Gulf War
Veterans' illnesses.
May 19, 2009--Gulf War Treatment RFA (5 proposals were
reviewed in September 2009)
. . . solicits submissions of applications for studies that:
Propose a controlled clinical trial or
epidemiological investigation of the effectiveness of
treatments for chronic multi-symptom illnesses in
Veterans of the 1990-1991 Gulf War compared with
subjects meeting case definition for fibromyalgia (FM)
and/or chronic fatigue syndrome (CFS).
Identify biomarkers (i.e., genetic,
neuroendocrine, immunological, biochemical,
physiological, etc.) that either predict or explain
differences in response to new treatments. Biomarker
studies proposed without an accompanying treatment
trial will not be considered for funding.
Trials to identify new symptom-specific
treatments (i.e. memory, attention, sleep, pain, etc.)
in ill Gulf War Veterans may be proposed.
Pharmacologic agents must have a plausible biological basis
for anticipated efficacy. Treatments that have been tested in
other chronic multi-symptom illnesses (i.e., FM or CFS) may be
proposed, even if they have been shown to be moderately
effective or ineffective in treating those conditions.
Applications not employing appropriate populations of Gulf War
Veterans will not be considered for funding.
VA has a proactive history of initiatives to further research on
Gulf War Veterans beginning with the 1994 launch of the first VA study
on the Health of Gulf War Veterans. Since then, VA has continuously
supported an extensive Gulf War research portfolio dedicated to
understanding chronic multi-symptom illnesses, long-term health effects
of potentially hazardous substances to which Gulf War Veterans may have
been exposed during deployment, and conditions or symptoms that may be
occurring with higher prevalence in Gulf War Veterans, such as
Amyotrophic Lateral Sclerosis (ALS), multiple sclerosis, and brain
cancer.
VA is committed to funding new clinical trials to identify new
therapies for ill Gulf War Veterans as well as using emerging
technologies to move in new directions. VA recently announced funding
available for VA researchers interested in conducting clinical trials
to test treatments used for other chronic multi-symptom illnesses such
as chronic fatigue syndrome and fibromyalgia. The five applications
were received and reviewed in September 2009. The results of these and
other clinical investigations, together with new discoveries using the
newest and most advanced technology, are expected to lead to improved
treatments and a better quality of life for Gulf War Veterans.
VA has provided funding to UTSW Medical Center, through a contract
from the Dallas VA Medical Center, for research that focuses on a new
national survey of Gulf War Veterans; a proposed genome-wide
association study of participants in the national survey to identify
genetic markers of illness and potential susceptibility to illness; and
identification of alterations in brain imaging that correspond to
specific neuropsychological measurements (i.e. memory, attention,
executive function, etc.). Due to unsatisfactory contract performance,
the option to extend the contract 1 year was not exercised. The funding
will be redirected to other VA-funded Gulf War research projects,
moving in similar directions, and utilizing research capacities in
place. Specifically, VA will undertake the following efforts:
Genome Wide Association Study (GWAS) of GWVI, Chronic
Fatigue and Fibromyalgia;
Request For Applications (RFA) for new treatments for
ill Gulf War Veterans;
RFA for Gulf War Research including, but not limited
to:
Diagnostic Tests to identify ill Gulf War
Veterans
Diagnostic tests to identify subpopulations
of ill Gulf War Veterans
Neuroimaging paired with
neurocognitive/neuropsychological testing
Structural and/or functional
neuroimaging
Proteomics
Gene expression/polymorphisms
Genetic susceptibility
Gene expression and/or polymorphisms
Other illnesses potentially affecting Gulf
War Veterans (studied in a Gulf War Veteran population)
ALS
Multiple Sclerosis
Animal Studies
New treatment targets
Pathophysiological mechanisms
Mechanisms that underlie persistence
of symptoms
These studies should lead to improved understanding of these
diseases and development of new treatments by identifying disease
susceptibilities, underlying damage pathways, and potential treatment
targets.
VA research program for Gulf War illnesses is robust and we are
confident that through this and other Federal research initiatives,
such as the Congressionally Directed Medical Research Program (CDMRP)
for Gulf War research, we will discover ways to provide enhanced health
care for these ill Veterans.
Question 9: What areas of Gulf War Illnesses is VA funding
research? When do you expect to see the results of these studies?
Response: Attached is a Gulf War research project list for FY07,
FY08 and FY09. Data analysis, for any research project, usually takes
at least 12 and often 15--18 months before any results--peer-reviewed
scientific literature--are published.
The average length of a research study is 4 years. It typically
takes several years after funds have been provided before sufficient
data can be accumulated, analyzed, and written as a manuscript. Once a
manuscript has been submitted, it usually takes a minimum of 6-12
months for the manuscript to be peer reviewed and published by a
scientific journal. Results are not considered final until results are
peer reviewed and published. Clinical trials can even take longer
before the results appear in a publication because results come only
after the trial has been completed. This can take many years from
beginning to the end. Additional results/publications may occur after a
project is presented to scientific groups, professional associations,
etc. or from further data analysis.
Public Law 102-585, as amended by Public Law 105-368, requires the
VA to submit an annual Report on the status of Federally sponsored
research on Gulf War Veterans' illnesses. Known as ``The Annual Report
to Congress on Federally Sponsored Research on Gulf War Veterans'
Illnesses''--this report provides Congress with an overview of Federal
research activities for a given calendar year and highlights important
research findings and milestones. Their have been 15 reports submitted
to Congress.
The reports can be found at the following Web link: http://
www.research.va.gov/resources/pubs/pubs--
individual.cfm?Category=Gulf%20War%20Reports
The annual report covers the research activities of the Departments
of Veterans Affairs, Defense (DoD), and Health and Human Services
(HHS). Although each annual report contains the same sections as
previous reports, key differences exist in the information reported.
These reports discuss the results of Gulf War research that were
published in a calendar year. Published research results and Federally
funded programs are categorized into 5 primary Focus Areas: Brain and
Nervous System Function; Environmental Toxicology; Immune Function;
Reproductive Health; and Symptoms and General Health. In addition, the
appendices are revised each year to reflect changes in funding amounts,
new research findings, the addition of new programs, and the completion
of previously funded studies.
Question 10: How much weight does VA place on IOM and RAC reports
when determining presumptions for service-connected disabilities for
the purposes of benefits and health care? Does VA ever make
determinations of service-connection for disabilities without the use
of IOM and RAC reports? Please explain.
Response: Under the provisions of Public Law 105-277, The Persian
Gulf War Veterans Act and Public Law 105-368, the Veterans Programs
Enhancement Act, VA entered into a contract with the National Academy
of Sciences (NAS) to review and evaluate the scientific and medical
literature regarding associations between illnesses and environmental
exposures associated with Gulf War service. VA considers reports from
the NAS in determining whether any medical condition warrants a
presumption of service connection based on Gulf War service. Recently,
VA announced it was establishing presumptions of service connection for
certain conditions based on the most recent IOM Study.
The Research Advisory Committee on Gulf War Veterans' Illness,
(RAC-GWVI) was established by the Secretary of Veterans Affairs in
March 2002 to provide advice and make recommendations to the Secretary
of Veterans Affairs on proposed research plans and strategies related
to understanding and treating the health consequences of military
service in the Southwest Asia theater of operations during the 1990-
1991 Gulf War (Operations Desert Shield and Desert Storm).
The Secretary considers all advice and recommendations of both the
NAS and the RAC-GWVI when determining whether a presumption of service
connection should be established for a particular condition. As
described above, VA has an informal process of tiered review and
recommendations with respect to IOM reports, to enable the Secretary to
meet the statutory requirements applicable to such reports.
The Secretary of Veterans Affairs has statutory authority to make
determinations of presumptive service connection for disabilities
without relying on IOM and RAC reports.
Question 11: How recently was the Veterans Health Initiative (VHI)
Independent Study Guide for treating 1991 Gulf War Veterans updated? Do
you have a copy of that study guide which you can provide to the
Committee?
Response: VHA has just started a major revision of this document.
The last update was completed in 2002. A copy of that VHI is attached.
Our new initiative is to make the information in this program more
relevant to busy providers and to modularize the content so that it is
more accessible. The Office of Public Health and Environmental Hazards
and the Employee Education System are working together on this project.
We have an American Association for the Advancement of Science (AAAS)
fellow with advanced degrees in postsecondary education and computer
technology to spearhead this initiative.
Attachment 1: FY 2007 ORD Support for Ongoing War Research Projects
----------------------------------------------------------------------------------------------------------------
FY 07
End Date ----------------------------------------------------------------------------------------------------------------------------------------------------------
10/15/08 VA-138 $ 235,241 $ 209,289
----------------------------------------------------------------------------------------------------------------
12/31/09 VA-137 $ 224,294 $ 199,550
----------------------------------------------------------------------------------------------------------------
12/31/08 VA-108 $ 224,917 $ 200,104 VA-108
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-142 $ 991,510 $ 882,126
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-119 $ 168,600 $ 150,000 VA-119
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-133 $ 112,400 $ 100,000
----------------------------------------------------------------------------------------------------------------
06/30/09 VA-101 $ 112,010 $ 31,250 $ 68,403 68403
----------------------------------------------------------------------------------------------------------------
12/31/09 VA-132 $ 112,400 $ 100,000
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-131 $ 163,579 $ 145,533
----------------------------------------------------------------------------------------------------------------
03/31/09 VA-107 $ 210,638 $ 187,400 VA-107
----------------------------------------------------------------------------------------------------------------
12/31/07 VA-096 $ 135,127 $ 120,220 VA-096
----------------------------------------------------------------------------------------------------------------
12/31/09 VA-125 $ 743,779 $ 661,725 VA-125
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-126 $ 165,565 $ 147,300 VA-126
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-129 $ 168,600 $ 150,000 VA-129
----------------------------------------------------------------------------------------------------------------
09/30/08 VA-113 $ 110,152 $ 98,000
----------------------------------------------------------------------------------------------------------------
12/31/08 VA-134 $ 77,640 $ 69,075
----------------------------------------------------------------------------------------------------------------
12/31/08 VA-135 $ 79,242 $ 70,500
----------------------------------------------------------------------------------------------------------------
03/31/08 VA-130 $ 217,056 $ 62,600 $ 130,510
----------------------------------------------------------------------------------------------------------------
03/31/09 VA-109 $ 317,503 $ 149,900 $ 132,576 VA-109
----------------------------------------------------------------------------------------------------------------
03/31/07 VA-097 $ 134,628 $ 119,776 VA-097
----------------------------------------------------------------------------------------------------------------
06/30/08 VA-117 $ 115,772 $ 103,000 VA-117
----------------------------------------------------------------------------------------------------------------
06/30/07 VA-118 $ 119,453 $ 106,275 VA-118
----------------------------------------------------------------------------------------------------------------
06/30/07 VA-148 $ 71,009 $ 63,175
----------------------------------------------------------------------------------------------------------------
$ 6,727,775
----------------------------------------------------------------------------------------------------------------
03/31/10 VA-149 $ 129,861 $ 115,535 $115,535
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-143 $ 112,400 $ 100,000
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-144 $ 112,400 $ 100,000
----------------------------------------------------------------------------------------------------------------
03/31/09 VA-145 $ 224,800 $ 200,000
----------------------------------------------------------------------------------------------------------------
12/31/09 VA-146 $ 256,160 $ 227,900
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-123 $ 178,447 $ 158,761 VA-123
----------------------------------------------------------------------------------------------------------------
03/31/08 VA-090 $ 449,990 $ 250,000 $ 150,347 VA-090
----------------------------------------------------------------------------------------------------------------
09/30/07 VA-080 $ 252,602 $ 106,000 $ 118,735 VA-080
----------------------------------------------------------------------------------------------------------------
Attachment 2: FY 2008 ORD Support for Ongoing War Research Projects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Full Name VAMC Title Focus Total FY Start Date End Date FY 08
2008 *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Trials $ 487,937
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Amin, Mohammad M Northport, NY Inspiratory flow Prevelance and $ 258,136 10/16/05 10/15/08 VA-138 $ 258,136 $ 20,369 $ 189,289 $20,000
dynamics during treatment of
sleep in GWS & sleep
the effect of disturbances in
CPAP GW veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Downing, Mia M. (Ph.D.) East Orange, NJ Telemedicine Feasibility of $ 12,476 01/02/05 12/31/07 VA-108 $ 12,476 $ 11,100
Treatment for performing
Veterans with Cognitive
Gulf War Illness Behavioral
Therapy (CBT)
via telephone
with Gulf War
veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tuteja, Ashok K. (M.D., M.P.H.) Salt Lake City, Diarrhea- Treatment of GW $ 217,325 01/01/06 12/31/09 VA-137 $ 217,325 $ 193,350
UT Predominant veterans with
Irritable Bowel gastrointestinal
Syndrome in symptoms
Persian Gulf
Veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biomarkers $ 4,652,315
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fink, John K. (M.D.) Ann Arbor, MI Novel Cause of Gene mutations in $ 110,152 10/01/04 09/30/08 VA-113 $ 110,152 $ 98,000 110152
Motor Neuron veterans with
Disease ALS (includes 40
GW veterans from
registry)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fiore, Louis D. (MD) Boston, MA VA Gulf War Gulf War Brain $ 1,091,547 08/01/02 09/30/08 VA-142 $ 1,091,547 $ 971,127
Biorepository and DNA Bank
Trust
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Klimas, Nancy G. (M.D.) Miami, FL Immunologic Immune $ 112,400 01/01/06 12/31/09 VA-132 $ 112,400 $ 100,000
Mechanisms and dysfunction as a
Biomarkers in mediator of
Gulf War Illness persistent
illness in both
CFS and ill GW
veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Molina-Vicenty, Hector D. St. Louis, MO Evaluation of Autonomic system $ 173,321 10/01/04 03/31/09 VA-107 $ 173,321 $ 154,200 VA-107
(M.D.) Blanchard, Melvin Stress Response and neurohumoral
(M.D.) Reda, Domenic J. Systems in Gulf dysregulation in
(Ph.D.) War Veterans Gulf War
with CMI veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Oddone, Eugene Z. (M.D.) Durham, NC Genetic Identify genes $ 2,116,602 07/01/08 09/30/12 VA-151 $ 2,116,602 $ 1,883,098
Epidemiology of that may confer
ALS Veterans susceptibility
to the
development of
ALS and examine
the interplay
between
environmental
exposures and
genetic
susceptibility
to ALS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pasinetti, Giulio M. (M.D., Bronx, NY Biomarkers Identification of $ 299,165 07/01/07 06/30/09 VA-101 $ 299,165 $ 125,000 $ 141,161
Ph.D.) Discovery in ALS biomarkers for
ALS in CSF and
serum from Gulf
War veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cook, Dane B. (Ph.D.) East Orange, NJ Functional Functional $ 95,382 04/01/06 12/31/07 VA-096 $ 95,382 $ 72,359 $ 12,500 VA-096
Imaging of Pain imaging of Gulf
in Veterans with War veterans
Unexplained with unexplained
Muscle Pain musculoskeletal
pain
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Weiner, Michael W. (M.D.) San Francisco, CA Effects of Gulf Magnetic $ 653,747 01/01/05 12/31/09 VA-125 $ 653,747 $ 581,625 VA-125
War Illness on Resonance
Brain Structure, Imaging (MRI)
Function and and Spectroscopy
Metabolism: MRI/ (MRS) of Gulf
MRS at 4 Tesla War veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Gulf War Veterans Illnesses $ 758,497
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Li, Mian (M.D., Ph.D.) Washington, DC Autonomic Autonomic delayed 09/30/06 06/30/11 VA-134 $--
Functions of dysfunction as
Gulf War an underlying
Veterans with cause of
Unexplained unexplained
Illnesses symptoms in GW
veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Li, Mian (M.D., Ph.D.) Washington, DC Motor Neuron Loss or damage of delayed 09/30/06 12/31/10 VA-135 $--
Function of Gulf motor nerve
War Veterans cells in GW
with Excessive veterans with
Fatigue muscle and joint
pain, muscle
spasm, or
fatigue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 2: FY 2008 ORD Support for Ongoing War Research Projects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bach, Ronald R. (Ph.D.) Minneapolis, MN Tissue Factor and Impaired blood $ 248,741 04/01/06 9/30/209 VA-130 $ 248,741 $ 221,300
Gulf War- flow and
Associated circulation as a
Chronic cause of
Coagulopathies cognitive
Gulf War- difficulties,
Associated somatic pain,
Chronic fatigue
Coagulopathies:
Tissue Factor,
Coagulation, and
Immune System
Activation.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Diamond, David M. (Ph.D.) Tampa, FL Effects of Stress Neurobiological $ 321,148 04/01/05 03/31/09 VA-109 $ 321,148 $ 149,900 $ 135,819 VA-109
on Memory: Brain basis of memory
Circuits, and development
Mechanisms and of new therapies
Therapeutics for memory
storage and
retrieval
dysfunction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Kang, Han K. (Dr.P.H.) Washington, DC Estimates of Prevalence of $ 66,597 07/01/05 06/30/08 VA-117 $ 66,597 $ 59,250 VA-117
Cancer cancer
Prevalence in (including brain
Gulf Veterans cancers) in Gulf
Using State War veterans
Registries
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mitchell T. Wallin (M.D., Washington, DC Multiple Evaluation of the $ 122,010 10/01/07 09/30/10 VA-152 $ 122,010 $ 108,550
M.P.H.) Sclerosis in risk of
Gulf War developing MS in
Veterans GW veterans
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Animal Models of GW Exposures $ 738,996 $ 6,637,745
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shetty, Ashok (Ph.D.) Durham, NC Behavior of Effects of $ 268,901 04/01/07 03/31/10 VA-149 $ 268,901 $ 239,236
Neural Stem pyridostigmine
Cells in a Rat bromide, DEET,
Model of GWS and permethrin
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mullan, Michael (M.D., Ph.D.) Tampa, FL Proteomic Effects of $ 224,800 04/01/06 03/31/09 VA-145 $ 224,800 $ 200,000
Analysis of pyridostigmine
Cellular bromide, DEET,
Response to and permethrin
Biological
Warfare Agents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Panter, Scott (Ph.D.) San Francisco, CA Direct Delivery Effects of $ 245,295 01/01/06 12/31/09 VA-146 $ 245,295 $ 208,234 $ 10,000
of Neurotoxins pyridostigmine
to the Brain by bromide, DEET,
an Intranasal and permethrin
Route
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Research Advisory Committee on Topeka, KS Annual Operating $ 400,000 not a
Gulf War Veterans' Illnesses Budget project
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 2: FY 2008 ORD Support for Ongoing War Research Projects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
$ 7,037,745
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total FY
2008
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
UTSW IDIQ $
Contract 15,000,000
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
$
22,037,745
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* Includes 12.4% administrative overhead *
Attachment #3: Projected FY 2009 ORD Support for Ongoing Gulf War Research Projects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Start
Full Name VAMC Title Focus Total FY 2009 * Date End Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Trials $ 18,196
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amin, Mohammad M Northport, NY Inspiratory flow Prevelance and $ 9,819 10/16/05 10/15/08
dynamics during sleep treatment of sleep
in GWS & the effect of disturbances in GW
CPAP veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tuteja, Ashok K. (M.D., M.P.H.) Salt Lake City, UT Diarrhea-Predominant Treatment of GW 01/01/06 12/31/09
Irritable Bowel veterans with
Syndrome in Persian gastrointestinal
Gulf Veterans symptoms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lin, Henry C. (M.D.) Albuquerque, NM Bacterial Overgrowth Treatment of GW $ 8,377 10/01/08 09/30/11
Associated with veterans with
Chronic Mult-Symptom gastrointestinal
Illness Complex symptoms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biomarkers $ 7,327,628
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiore, Louis D. (MD) Boston, MA VA Gulf War Gulf War Brain and DNA $ 5,664,976 08/01/02 09/30/08
Biorepository Trust Bank
--------------------------------------------------------------------------------------------------------------------------------------------------------
Klimas, Nancy G. (M.D.) Miami, FL Immunologic Mechanisms Immune dysfunction as a $ 56,200 01/01/06 12/31/09
and Biomarkers in Gulf mediator of persistent
War Illness illness in both CFS
and ill GW veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Molina-Vicenty, Hector D. (M.D.) St. Louis, MO Evaluation of Stress Autonomic system and $ 93,226 10/01/04 03/31/09
Blanchard, Melvin (M.D.) Reda, Response Systems in neurohumoral
Domenic J. (Ph.D.) Gulf War Veterans with dysregulation in Gulf
CMI War veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oddone, Eugene Z. (M.D.) Durham, NC Genetic Epidemiology of Identify genes that may $ 377,557 07/01/08 09/30/12
ALS Veterans confer susceptibility
to the development of
ALS and examine the
interplay between
environmental
exposures and genetic
susceptibility to ALS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pasinetti, Giulio M. (M.D., Ph.D.) Bronx, NY Biomarkers Discovery in Identification of $ 274,432 07/01/07 06/30/09
ALS biomarkers for ALS in
CSF and serum from
Gulf War veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cook, Dane B. (Ph.D.) East Orange, NJ Functional Imaging of Functional imaging of $ 300,782 10/01/08 09/30/12
Pain in Veterans with Gulf War veterans with
Unexplained Muscle unexplained
Pain musculoskeletal pain
--------------------------------------------------------------------------------------------------------------------------------------------------------
Weiner, Michael W. (M.D.) San Francisco, CA Effects of Gulf War Magnetic Resonance $ 560,455 01/01/05 12/31/09
Illness on Brain Imaging (MRI) and
Structure, Function Spectroscopy (MRS) of
and Metabolism: MRI/ Gulf War veterans
MRS at 4 Tesla
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gulf War Veterans Illnesses $ 758,294
--------------------------------------------------------------------------------------------------------------------------------------------------------
Li, Mian (M.D., Ph.D.) Washington, DC Autonomic Functions of Autonomic dysfunction $ 25,880 09/30/06 12/31/08
Gulf War Veterans with as an underlying cause
Unexplained Illnesses of unexplained
symptoms in GW
veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Li, Mian (M.D., Ph.D.) Washington, DC Motor Neuron Function Loss or damage of motor $ 79,242 09/30/06 12/31/08
of Gulf War Veterans nerve cells in GW
with Excessive Fatigue veterans with muscle
and joint pain, muscle
spasm, or fatigue
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bach, Ronald R. (Ph.D.) Minneapolis, MN Tissue Factor and Impaired blood flow and $ 273,861 04/01/06 9/30/209
GulfWar-Associated circulation as a cause
Chronic of cognitive
CoagulopathiesGulf War- difficulties, somatic
Associated pain, fatigue
ChronicCoagulopathies:
Tissue
Factor,Coagulation,
and Immune System
Activation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diamond, David M. (Ph.D.) Tampa, FL Effects of Stress on Neurobiological basis $ 241,520 04/01/05 03/31/09
Memory: Brain of memory and
Circuits, Mechanisms development of new
and Therapeutics therapies for memory
storage and retrieval
dysfunction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mitchell T. Wallin (M.D., M.P.H.) Washington, DC Multiple Sclerosis in Evaluation of the risk $ 137,791 10/01/07 09/30/10
Gulf War Veterans of developing MS in GW
veterans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Animal Models of GW Exposures $ 581,415
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shetty, Ashok (Ph.D.) Durham, NC Behavior of Neural Stem Effects of $ 273,801 04/01/07 03/31/10
Cells in a Rat Model pyridostigmine
of GWS bromide, DEET, and
permethrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mullan, Michael (M.D., Ph.D.) Tampa, FL Proteomic Analysis of Effects of $ 112,400 04/01/06 03/31/09
Cellular Response to pyridostigmine
Biological Warfare bromide, DEET, and
Agents permethrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panter, Scott (Ph.D.) San Francisco, CA Direct Delivery of Effects of $ 195,214 01/01/06 12/31/09
Neurotoxins to the pyridostigmine
Brain by an Intranasal bromide, DEET, and
Route permethrin
--------------------------------------------------------------------------------------------------------------------------------------------------------
$ 8,685,533
------------------------------------------------------------------------------------------------------------------------------------------- ---------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Distributed
by ORD in FY 2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
UTSW Medical center Dallas, TX Gulf War Veterans $ 6,862,503
Illnesses' Research
IDIQ Contract
--------------------------------------------------------------------------------------------------------------------------------------------------------
$ 15,548,036
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Distributed
(ORD) and
Obligated
(Contract) in FY
2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
Includes 12.4% administrative overhead (all projects except IDIQ Cotnract) *