[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.
[GRAPHIC] [TIFF OMITTED] T1878A.001

[GRAPHIC] [TIFF OMITTED] T1878A.002

[GRAPHIC] [TIFF OMITTED] T1878A.003


                                 
       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 [email protected], 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) *

                                 
