[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
PERSIAN GULF WAR: AN ASSESSMENT OF HEALTH OUTCOMES ON THE 25TH
ANNIVERSARY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
TUESDAY, FEBRUARY 23, 2016
__________
Serial No. 114-57
__________
Printed for the use of the Committee on Veterans' Affairs
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COMMITTEE ON VETERANS' AFFAIRS
JEFF MILLER, Florida, Chairman
DOUG LAMBORN, Colorado CORRINE BROWN, Florida, Ranking
GUS M. BILIRAKIS, Florida, Vice- Minority Member
Chairman MARK TAKANO, California
DAVID P. ROE, Tennessee JULIA BROWNLEY, California
DAN BENISHEK, Michigan DINA TITUS, Nevada
TIM HUELSKAMP, Kansas RAUL RUIZ, California
MIKE COFFMAN, Colorado ANN M. KUSTER, New Hampshire
BRAD R. WENSTRUP, Ohio BETO O'ROURKE, Texas
JACKIE WALORSKI, Indiana KATHLEEN RICE, New York
RALPH ABRAHAM, Louisiana TIMOTHY J. WALZ, Minnesota
LEE ZELDIN, New York JERRY McNERNEY, California
RYAN COSTELLO, Pennsylvania
AMATA COLEMAN RADEWAGEN, American
Samoa
MIKE BOST, Illinois
Jon Towers, Staff Director
Don Phillips, Democratic Staff Director
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATION
MIKE COFFMAN, Colorado, Chairman
DOUG LAMBORN, Colorado ANN M. KUSTER, New Hampshire,
DAVID P. ROE, Tennessee Ranking Member
DAN BENISHEK, Michigan BETO O'ROURKE, Texas
TIM HUELSKAMP, Kansas KATHLEEN RICE, New York
JACKIE WALORSKI, Indiana TIMOTHY J. WALZ, Minnesota
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
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Tuesday, February 23, 2016
Page
Persian Gulf War: An Assessment of Health Outcomes on the 25th
Anniversary.................................................... 1
OPENING STATEMENTS
Honorable Mike Coffman, Chairman................................. 1
Honorable Ann M. Kuster, Ranking Member.......................... 2
WITNESSES
Carolyn Clancy, M.D., Deputy Under Secretary for Health for
Organizational Excellence, U.S. Department of Veterans Affairs. 4
Accompanied by:
Stephen Hunt, M.D., M.P.H., Director, Post-Deployment
Integrated Care Initiative, U.S. Department of Veterans
Affairs
Victor Kalasinsky, Ph.D., Senior Program Manager, Gulf War
Veterans' Illnesses Research, U.S. Department of Veterans
Affairs
Deborah Cory-Slechta, Ph.D., Professor of Environmental Medicine,
Pediatrics and Public Health Sciences, Acting Chair, Department
of Environmental Medicine, University of Rochester School of
Medicine....................................................... 6
Prepared Statement........................................... 27
Roberta F. White, Ph.D., Chair, Department of Environmental
Health, Boston University School of Public Health.............. 9
Prepared Statement........................................... 30
Accompanied by:
Mr. James H. Binns, Gulf War Researcher, Former Chairman,
Research Advisory Committee on Gulf War Veterans'
Illnesses
Mr. Anthony Hardie, Gulf War Veteran, Director, Veterans for
Common Sense................................................... 10
Prepared Statement........................................... 33
Accompanied by:
Mr. David K. Winnett, II, Gulf War Veteran
STATEMENTS FOR THE RECORD
Lung Cancer Alliance............................................. 38
National Gulf War Resource Center................................ 39
Mr. James H. Binns............................................... 41
Ms. Montra Denise Nichols, MSN................................... 69
Kimberly Sullivan, PhD........................................... 73
Mr. David K. Winnett, II......................................... 75
Lea Steele, Ph.D................................................. 81
QUESTIONS FOR THE RECORD
Questions from Chairman Mike Coffman for the Department of
Veterans Affairs:.............................................. 83
PERSIAN GULF WAR: AN ASSESSMENT OF HEALTH OUTCOMES ON THE 25TH
ANNIVERSARY
----------
Tuesday, February 23, 2016
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Oversight
and Investigations,
Washington, D.C.
The Subcommittee met, pursuant to notice, at 4:35 p.m., in
Room 334, Cannon House Office Building, Hon. Mike Coffman
[Chairman of the Subcommittee] presiding.
Present: Representatives Coffman, Roe, Huelskamp, Kuster,
and Walz.
Also Present: Representative Denham.
OPENING STATEMENT OF MIKE COFFMAN, CHAIRMAN
Mr. Coffman. Good afternoon. This hearing will come to
order. I want to welcome everybody to today's hearing entitled
``Persian Gulf War: An Assessment of Health Outcomes on the
25th Anniversary.''
First, as a preliminary matter, I would like to ask
unanimous consent that--let's see. Who do we have? Oh, I guess
they're not here. I don't have to do that.
Ms. Kuster. The answer is yes.
Mr. Coffman. As a fellow Gulf War veteran, I have invited
them. Unfortunately, they're not here. Let's see.
This hearing will examine VA's treatment of and current
health outcomes for veterans suffering from Gulf War illness.
The hearing will focus largely on the issues that have arisen
since our last hearing on Gulf War illness on March 13, 2013,
and specifically review VA's efforts to improve treatment and
outcomes. This hearing marks the 25th anniversary of the
Persian Gulf War, a conflict of swift intensity and short
duration with what could be the lowest incident of post-
traumatic stress disorder of any American war, according to
some reports, including VA's own National Center for Post-
Traumatic Stress Disorder.
Unfortunately, this anniversary also marks numerous
problems, some of which haven't improved since our hearing on
Gulf War illness 3 years ago. I'm deeply concerned about how VA
continues to characterize Gulf War illness as a mental
disorder, as evident in its current clinical guidelines. I'm
perplexed that these same clinical guidelines are based in part
on research that the Institute of Medicine has warned is
potentially biased or influenced by pharmaceutical
manufacturers. I'm also frustrated by the fact that VA is
prescribing psychotropic drugs for not only Gulf War illness
but apparently also for instances of traumatic brain injury and
post-traumatic stress. And I wonder about a possible connection
between drug manufacturers and their sponsored studies and the
high rate of prescription drugs being dumped on veterans with
Gulf War illness. My concerns regarding VA's overuse of drugs
are well founded, given this Committee's hearing last June that
revealed VA administrators acknowledging the practice of
overprescribing medication and turning veterans into drug
addicts.
VA has previously testified that Gulf War illness is not a
mental malady. And its own training course states that it,
quote, ``cannot be ascribed to any known psychiatric disorder,
somatoform disorder, PTSD, or depression,'' unquote. Even so,
VA continues to treat veterans as if Gulf War illness was a
psychiatric problem. And that is an affront to those who have
real physical ailments due to their service.
I find it hard to believe cardiovascular disease, the
physical scarring of lungs, central sleep apnea, head trauma,
cataracts, and a variety of cancers are the manifestation of
psychosomatic or psychiatric issues. If it could be as simple
as a veteran thinking such things exist and then they
disappear, I would think--simply think--VA is an organization
truly capable of caring for veterans, and all of the
Department's continued failures would simply be resolved.
What is even more frustrating is that the Institute of
Medicine is apparently recommending no more Gulf War illness
research be conducted. And that makes no sense whatsoever. But,
then again, VA has published so few recent studies that this
seems part and parcel of business as usual.
Gulf War veterans, myself among them, are tired of hearing
the same rhetoric from the VA. Quite frankly, I have had enough
of VA telling me one thing and doing the exact opposite. The
fact that very little, if anything, has changed in the 3 years
since we last held a hearing on VA's treatment of Gulf War
illness is not only completely unacceptable; it is infuriating.
I look forward to a spirited discussion on this important
issue.
With that, I yield to Ranking Member Kuster for any opening
remarks that she may have.
OPENING STATEMENT OF ANN M. KUSTER, RANKING MEMBER
Ms. Kuster. Thank you, Chairman Coffman.
And thank you for your service in the Gulf War. We're all
grateful for that.
Sunday marks the 25th anniversary of the end of Operation
Desert Storm. And over the course of this quarter century, many
veterans who served in that conflict have suffered from
symptoms that are not readily identifiable or well understood.
In fact, nearly 30 percent of Gulf War veterans suffer from
Gulf War illness. These veterans still struggle to receive
accurate diagnoses for their symptoms and access to needed
health care. These veterans struggle to get effective treatment
for their conditions. And for too many years, veterans
suffering from Gulf War illness have been told: It's all in
your head.
I think we can all agree today that Gulf War illness is not
psychosomatic. Gulf War illness is a chronic, often painful,
and sometimes debilitating disease. And our veterans deserve
access to VA care and the most effective treatments for their
illnesses and injuries.
I'm concerned that recent findings from the Institute of
Medicine may have been interpreted by some to mean that
veterans should only receive mental health treatment for Gulf
War illness. I'm also concerned that recent research findings
may be interpreted to deny Gulf War veterans and all veterans
suffering from ill-defined conditions access to VA health care
and effective treatments.
I wish to hear from all of our witnesses today so that we
may begin to better understand the conclusions and
recommendations of the researchers and experts in this field.
It's so very important that we develop clear goals to ensure
that our veterans receive access to health care, both for
mental health and physical health symptoms, and the most
effective treatment for their service-connected injuries and
illnesses.
We know that veterans of the Iraq and Afghanistan wars are
also coming to VA hospitals in need of treatment for their
symptoms, sometimes symptoms that are similar to those suffered
by Gulf War veterans. That's why it's vital that the research
continues so that we will best understand the very best
treatments and continue to explore issues relating to causation
in order to protect the health of our servicemembers going
forward. I believe it's incumbent upon us to learn as much as
we can about what are our Nation is asking from our
servicemembers and their families when they volunteer and raise
their right hand. We must recognize and be prepared to address
the cost of that service and use our best efforts to ensure
that our veterans are made whole again after returning home.
And here I might just add that the Chairman and I spent
time together over Thanksgiving in Afghanistan. And one of the
concerns is, if we don't understand the causation behind the
Gulf War syndrome and exposure to toxins or other trauma,
psychological injury, PTSD, TBI, and how this is all coming
together, we're not going to have an understanding of what it
means to put our current troops in harm's way in Iraq and
Afghanistan. So I feel very strongly that we need to continue
to investigate causation while we move forward with treatment
for veterans that have already been exposed.
So thank you, and I yield back.
Mr. Coffman. Thank you, Ranking Member Kuster.
We are now joined by United States Representative Jeff
Denham from the State of California, a Gulf War veteran.
I ask unanimous approval for Mr. Denham to be able to
participate in this hearing.
Ms. Kuster. Absolutely.
Welcome, Mr. Denham.
Mr. Coffman. So ordered.
Mr. Denham. I get my own card.
Mr. Coffman. Thank you, Ranking Member Kuster.
I ask that all Members waive their openings remarks as per
this Committee's custom.
With that, I invite the first and only panel to the witness
table. You are currently seated. On that panel, for the
Department of Veterans Affairs, we have Dr. Carolyn Clancy,
Deputy Under Secretary for Health for Organizational
Excellence. She is accompanied by Dr. Stephen Hunt, Director of
VA's Post-Deployment Integrated Care Initiative, U.S.
Department of Veterans Affairs, and Dr. Victor Kalasinsky--I
believe, got that wrong--senior program manager for VA's Gulf
War Veterans' Illnesses Research, VA.
Also on the panel, we have Dr. Deborah Cory-Slechta,
Professor of Environmental Medicine, Pediatrics and Public
Health Sciences, and Acting Chair of the Department of
Environmental Medicine at the University of Rochester School of
Medicine, who will be testifying in her capacity as chair on
the Committee on Gulf War and Health of the Institute of
Medicine.
Dr. Roberta F. White, chair of the Department of
Environmental Health at Boston University School of Public
Health, who is accompanied by Mr. James H. Binns, Gulf War
Researcher and former chairman of the Research Advisory
Committee on Gulf War Veterans' Illnesses.
And Mr. Anthony Hardie, a Gulf War veteran and Director of
Veterans for Common Sense, who is accompanied by Mr. David K.
Winnett, II, a Gulf War veteran.
I ask the witnesses to please stand and raise your right
hand.
[Witnesses sworn.]
Mr. Coffman. Very well. Sit down. Please be seated. And let
the record reflect that all witnesses have answered in the
affirmative.
Dr. Clancy, you are now recognized for 5 minutes.
STATEMENT OF CAROLYN CLANCY, M.D.
Dr. Clancy. Thank you. Good afternoon, Chairman Coffman,
Ranking Member Kuster, Members of the Subcommittee,
Representative Denham. I'm accompanied today by Dr. Stephen
Hunt, director of our Post-Deployment Integrated Care
Initiative. As Deputy Under Secretary for Organizational
Excellence and an internist, my background has been conducting
and supporting research to improve patient care and inform
public policy for much of my career. So I know how important it
is to get the science right and assure you that VA is taking
every step possible to advance research, clinical care, and
education on Gulf War illness.
Since our last hearing in 2013, VA has funded or conducted
over 60 studies. Funding for Gulf War research has increased
steadily from $5.6 million in 2011 to over $14 million this
year. And that's a very conservative estimate. For example, a
study funded this past June is a randomized trial of something
called CoQ10 thought to change subcellular function in a way
that could help treat the effects of Gulf War illness. Other
studies evaluate the effectiveness of a broad range of
treatments for musculoskeletal pain, fatigue, and cognitive
issues using exercise programs, magnetic stimulation, and other
innovative approaches. So, as we look for promising
interventions through research, VA is also working diligently
to treat these veterans that are now suffering from Gulf War
illness.
From 2000 to 2015 the percentage of Gulf War veterans
enrolled in our system has increased from 13 percent to about
33 percent. We offer continuing evaluation and treatment to the
over 700,000 men and women who served in Operations Desert
Shield and Desert Storm. We have centers of excellence, three
of them, called War Related Injury and Illness Study Centers,
or WRIISCs--and we want to express our appreciation to the
Congress for these--which are charged with conducting cutting-
edge research, clinical education, and providing specialized
care for Gulf War veterans with complex chronic unexplained or
very difficult-to-diagnosis conditions. And demand for their
services is no surprise; as the number of Gulf War veterans has
increased, demand for these services has also increased.
In addition, a total of 145,000 Gulf War veterans have
undergone a Gulf War registry exam allowing their health
concerns to be evaluated by VA physicians and enabling them to
be referred for additional care. We first learned from Gulf War
veterans just how important it is to integrate all the care and
services that veterans need, and to integrate and organize that
around the veteran and the veteran's needs. And, in fact, that
became an organizing principle for much of our system and team-
based primary care. And, in fact, that has helped us to
organize our referrals to community providers when necessary as
well.
We know that many Gulf War veterans are affected by a
debilitating cluster of medically unexplained chronic symptoms
that can include fatigue, headaches, joint pain, indigestion,
insomnia, dizziness, respiratory disease, memory problems. And
the chronic multisymptom illness we see so often in Gulf War
veterans is clearly not a psychological condition. So I want to
be very clear on that. We're committed to ensuring our
research, clinical care, and education takes into account all
of the factors that are relevant to returning that veteran to
the highest level of function. We have aggressively pursued and
fast-tracked studies in ways we can meet the research and
treatment needs for all veterans that have been affected by
environmental exposures. So that research serves two purposes.
One is to improve clinical care that we're providing now for
those enrolled in our system. And the other is as the basis for
presumptions or other benefits. Our philosophy has been to come
down on the side of the veteran when the science supports it.
And, as you've seen, we have made our policies more liberal for
C123 crews and are now adding new presumptives for veterans who
served at Camp Lejeune. In addition, we've been working with
Ron Brown at the National Gulf War Resource Center to address a
number of concerns and possible presumptions for Gulf War
veterans.
Going forward, we recognize that while we've learned a lot,
we need and value the ongoing feedback and input from our
stakeholders, this committee of course, the Research Advisory
Committee, the Veterans Service Organizations, and, very
importantly, Gulf War veterans themselves.
As we conduct an in-depth review of the most recent
Institute of Medicine report, we're going to include 2 full
days to receive public comments and feedback from our
stakeholders and partners to assure that VA's priorities are
informed by veterans and stakeholders.
You know, vigorous disagreements in science are part of the
landscape, and we welcome that at all times. That's what moves
science forward. And we're committed to hearing from all sides.
That concludes my testimony. My colleague and I look
forward to answering your questions that you or the Committee
may have.
[The prepared statement of Carolyn Clancy, M.D. appears in
the Appendix]
Mr. Coffman. Thank you, Dr. Clancy.
Dr. Cory-Slechta, you are now recognized for 5 minutes.
STATEMENT OF DEBORAH CORY-SLECHTA, PH.D.
Ms. Cory-Slechta. Good afternoon. Is this on?
I am Deborah Cory-Slechta, professor of environmental
medicine, pediatrics, and public health sciences, and acting
chair of the Department of Environmental Medicine at the
University of Rochester School of Medicine. I served as chair
of the ``Committee on Gulf War and Health, Volume 10,'' which
was released February 11 of this year. The committee that I was
chaired was asked to review and evaluate the scientific and
medical literature regarding associations between illness and
exposure to toxic agents, environmental or wartime hazards, or
preventative medicines or vaccines associated with Gulf War
service, paying particular attention to neurological disorders,
including Parkinson's, MS, ALS, and migraines, to cancer,
particularly brain cancer and lung cancer, and chronic
multisymptom illness, also known as Gulf War illness. Volume 10
updates two earlier Gulf War and Health reports: volume 4, in
2006, and volume 8, that was published in 2010.
The committee made recommendations for future research on
Gulf War veterans. And I would note that this committee was
composed of experts in neurology, epidemiology, pain,
psychiatry, neurocognitive disorders, environmental health, and
toxicology. And they were clinicians and researchers, none of
whom received funding from Gulf War illness research programs.
Volume 10 basically followed the approach used by earlier
committees. We held two public sessions at which we heard from
representatives of the VA, from Gulf War veterans, and Veterans
Service Organizations, Gulf War researchers, and
representatives of the VA Research Advisory Committee. We did
not address policy issues such as service-connection,
compensation or the cause of or treatment for Gulf War illness.
We conducted an extensive literature search, reviewed the
volumes 4 and 8 conclusions, as well as their primary and
secondary studies. We also looked at animal toxicology,
neuroimaging, and genetics. We tried to be totally inclusive.
We divided our studies into primary studies. They had to be
published in peer-reviewed journals demanding--or demonstrating
reporting rigorous methods, including information on a
persistent, not acute, health outcomes, used appropriate
laboratory testing as applicable, and had a study population
that was generalizable to and representative of the Gulf War
population.
Secondary studies were those studies that didn't meet all
of these criteria. Many of the secondary studies relied on
self-reports of diagnoses rather than examination by a health
professional or a medical record review. We used the same
categories of association that were used in the previous
volumes. I won't go through all those. Suffice it to say, we
have a sufficient evidence of a causal relationship, sufficient
evidence of an association, limited suggestive evidence of an
association, inadequate insufficient evidence or limited
suggestive evidence of no association.
The committee found that in spite of many millions of
dollars that have been spent on researching the health of Gulf
War veterans, there has been little substantial progress in our
understanding of their health, particularly of Gulf War
illness. The volume 10 committee found little evidence to
actually warrant changes to the volume 8 conclusions. We
fundamentally agree with the volume 8 conclusions regarding the
strength of the associations between deployment to the Gulf War
and adverse health outcomes. Veterans who were deployed to the
Gulf War have an increased risk for many long-term health
conditions with--including PTSD, Gulf War illness, chronic
fatigue syndrome, functional GI conditions, generalized anxiety
disorder, depression, and substance abuse. And in the testimony
that I've provided you, you can see our categories of
association with different health effects summarized in box 1.
As requested in its statement of tasks, the committee had
additional discussions pertaining to Gulf War illness,
specifically neurologic conditions, and lung and brain cancer,
as well as Gulf War illness itself. So Gulf War illness, of
course, is the signature adverse health outcome of having
served in the Persian Gulf. Multiple studies have found that
some Gulf War veterans, regardless of their country of origin
and their different deployment-related exposures, have
persistent debilitating and varying symptoms of Gulf War
illness. In spite of over two decades of research to define,
diagnose, and treat Gulf War illness, little progress has
actually been made in elucidating the pathophysiological
mechanisms that underlie it, the exposures that may have caused
it, or the treatments that are generally effective for it.
Gulf War illness is not an easily diagnosed condition. The
committee concluded it is not a psychosomatic illness, but it
does, like almost every disease and disorder that we know of,
prevent--present with diverse systems, many of which overlap
with other health conditions such as chronic fatigue,
neurodegenerative disorders, and musculoskeletal.
The committee concluded that, although the existence of an
animal model would be advantageous for identifying and
evaluating treatment strategies, we caution that developing an
animal model is really precluded by the absence of any
objective measures of chemical and nonchemical exposures during
Gulf War service, let alone the frequency, duration, or dose of
those exposures, or the highly likely interactive effects of
multiple exposures, about which we know almost nothing. We
found it unlikely that a single definitive causal agent will be
identified in the many years--this many years after the war.
Furthermore, many of the Gulf War studies have excluded the
psychological aspects of the condition with regard to both
diagnosis and treatment, although veterans report symptoms,
such as chronic pain and sleep disturbances, that may be
amenable to psychological therapies alone or in conjunction
with other treatments.
We found new--little new information pertaining to MS,
Parkinson's, or Alzheimer's disease, or migraines. We did
recommend that ALS is the only neurologic disease for which we
did find limited suggestive evidence for an association. But
because the timeframe has been too short to really look at
this, we recommended additional followup for prevalence of ALS
in this population.
Similarly, we found evidence for brain cancer to be
inadequate, insufficient, and it found--we found no
statistically significant increase in the current risk of brain
concern in deployed Gulf War veterans compared to nondeployed
counterparts. A finding that's actually mirrored in another
recent IOM study.
With regard to lung cancer, there--in the 10 to 15 years
follow-up that have been reported may not, again, like ALS,
have been adequate--an adequate timeframe to really see whether
in fact--
Mr. Coffman. Dr. Slechta, I'm going to have to ask you to
move along, simply because you're at 7 minutes right now.
Ms. Cory-Slechta [continued]. Sorry. Okay.
In conclusion, what is striking about this and prior Gulf
War and Health Committee's finding is that--well, I'll just
skip to the end.
Let me just quickly go through these.
Recognize the connections and complex relations between
brain and physical functioning and do not exclude any aspect of
Gulf War illness. With respect to improving its diagnosis and
treatment, the Department of Veterans Affairs and Department of
Defense should develop a joint and cohesive strategy on
incorporating emerging diagnostic technologies, personalized
approaches to medical care into sufficiently powered future
research to inform the studies. I would also say, in regards to
what I heard before, the importance of biomonitoring of
exposures before, during, and after military--the involvement
in the military is going to be critical to ultimately providing
any associations to chemical exposures. There need to be
follow-up for neurodegenerative diseases that have long
latencies and are associated with aging, as I mentioned before.
And let's see. Without definitive and verifiable individual
veteran exposure information, further studies to determine
cause and effect relationship between Gulf War chemical
exposures and health conditions in Gulf War veterans should not
be undertaken. We did come up with a list of outcomes where we
believe that there are sufficient data already to suggest an
association, that we don't need to do more studies to
redemonstrate those, somewhere, 25 years after the war, we're
not likely to see anything, and so some of those kinds of
health conditions didn't warrant follow-up, as well as some
that we said had a longer latency and still needed to be
considered.
And, finally, one other thing was to begin to break out
sex-specific and race/ethnicity-specific health information,
which may be important not only to understanding different
vulnerabilities by sex and race but also in terms of
understanding mechanisms and treatment for disease.
Thank you. And I'm sorry for going over time.
[The prepared statement of Deborah Cory-Slechta appears in
the Appendix]
Mr. Coffman. Thank you, Dr. Slechta.
Dr. White, you are now recognized for 5 minutes.
STATEMENT OF ROBERTA F. WHITE, PH.D.
Ms. White. Chairman Coffman, Ranking Member Kuster, and
Members of the House Veterans Affairs Subcommittee on Oversight
and Investigations, it's the 25th anniversary of the Gulf War.
Our veterans won this conflict in less than a week. However,
concern remains high that the troops who produced this victory
are and will remain ill without legitimate acknowledgement of
their health problems and associated disabilities and without
effective treatment options now or in the future.
Despite decades of scientific evidence to the contrary, the
VA and the Institute of Medicine have recently produced
documents that minimize the poor health of these veterans by
terming their illnesses to be functional, a medical term for
psychiatric illness. This injustice is then compounded by a VA
treatment guideline that suggests ineffective, unproven,
palliative, and potentially harmful treatments for Gulf War
illness that focus on psychiatric symptomatology. I speak as a
clinician scientist who has worked with ill Gulf War veterans
clinically and in research for over 20 years. My work on Gulf
War illness is part of a 35-year career in which I have studied
the effects of exposures to neurotoxic chemicals in adults and
children. For 8 years, until last fall, I served as scientific
director of the Research Advisory Committee on Gulf War
Veterans' Illnesses. It has been known since a year or two
after their return from the Gulf that a subset of Gulf War
veterans was experiencing debilitating physical illness.
Research beginning at that time and continuing to the present
has produced a consensus of scientific knowledge about this
illness that I will summarize briefly.
First, dozens of studies in multiple countries reveal that
approximately 30 percent of the 1991 Gulf War veteran
population suffers from a characteristic pattern of physical
health symptoms that we call Gulf War illness. This pattern of
health symptoms is not seen in veterans of other conflicts.
Second, this illness is not the result of stress or other
psychiatric factors. Rates of post-traumatic stress disorder
are typically less than 10 percent. Furthermore, rates of Gulf
War illness are not significantly higher in Gulf War veterans
with psychiatric diagnoses.
Third, Gulf War illness is associated with exposures to
chemicals present in theatre, especially pesticides and
pyridostigmine bromide, and possibly nerve gas sarin and
particulates from the oil well fires.
Fourth, effective treatments for Gulf War illness and other
disorders that are induced by chemical exposures that damage
the brain do not exist at present. However, recent research has
identified treatment options that target specific nervous
system and immunological mechanisms of Gulf War illness. These
treatments are now being piloted. Despite these treatment
advances, new recommendations for treatment of Gulf War illness
from VA emphasize immediate referral for mental health
evaluation. In addition, cognitive behavioral therapy is
suggested. This is a palliative treatment at best and has been
shown to be minimally effective in VA research on Gulf War
veterans.
Even worse, the treatment guidelines recommend 11 drugs to
treat Gulf War illness, 10 of them psychiatric. All 11 drugs
are noted in the guidelines to have significant adverse side
effects, including suicidal ideation. And these medications
have not been studied with regard to their effectiveness in the
treatment of Gulf War illness. The recent volume 10 Institute
of Medicine report further contributes to this situation by
minimizing the health problems of Gulf War veterans and again
placing a psychiatric cast on them. Although the volume 10 IOM
report states that the science has not changed since the volume
8 report, its conclusions fly in the face of the scientific
consensus on Gulf War illness that I have described. The volume
8 report concluded that Gulf War illness cannot be reliably
ascribed to any known psychiatric disorder. The volume 10
report distorts and disavows this conclusion by saying that the
illness cannot be fully explained by any psychiatric disorder.
Unlike prior reports that support mechanistic scientific
research on Gulf War illness, volume 10 suggests that it is
time research efforts focus on mind/body connectedness, and
that further research to determine the relationships between
Gulf War exposures and health conditions in Gulf War veterans
should not be undertaken. To recommend stopping research into
the mechanisms underlying the disease just as research into
these mechanisms has begun to make real progress is shockingly
shortsighted. And to suggest that psychiatric research has been
neglected could not be further from the truth.
During the first 15 years after the war, Federal Gulf War
research focused mainly on psychiatric issues with negative
results. It is unthinkable that the scientific progress now
being made should be halted by a return to the psychogenic era.
Thank you.
[The prepared statement of Roberta F. White appears in the
Appendix]
Mr. Coffman. Thank you, Dr. White.
Mr. Hardie, you're now recognized for 5 minutes.
STATEMENT OF ANTHONY HARDIE
Mr. Hardie. Thank you, Mr. Chairman, and Ranking Member and
Members of this Committee for your service, for this hearing,
and for the opportunity to speak with you today.
This is just a brief overview. There are more details in my
written submission. I really hope that you'll take the time to
read the few pages of it.
I'm Anthony Hardie, a 1991 Gulf War and Somalia veteran.
I'm director of the Veterans for Common Sense, and while I've
provided testimony on several occasions, today is especially
notable. Exactly 25 years ago tonight, we launched the ground
war of Operation Desert Storm and successfully liberated
Kuwait. Tonight, I would like to--for us to remember and honor
the nearly 300 warriors who made the ultimate sacrifice. I
would also like us to remember and honor our Gulf War veterans,
including those in this room and watching, and our leaders who
led us to decisive military victory.
Our war was relatively short, but you've heard our stories
before. And with one-fourth and one-third of us coming home
with serious and debilitating health issues now known as Gulf
War illness, we faced a new battle: a long war to obtain health
care, effective health care, and VA assistance from entrenched
government officials who seemed intent on minimization and
denial at every turn. Even through to today, the VA describes
our toxic wounds as medically unexplained. And, finally, in
1998, we won enactment of two landmark bills for Gulf War
veterans to guarantee health care and benefits based on
research. Yet from the beginning, VA officials circumvented
their implementation that leads us to today.
The Institute of Medicine recently released its final
report on the Gulf War and Health series under VA contract as
directed by the 1998 legislation. It's highly problematic. As I
walked through the airport on my way home from the report's
release, the weight of the bag with nearly two decades of these
IOM reports was heavy on my shoulder. And I want to show that
weight.
My heart was even heavier because their collective weight
has added little to nothing for Gulf War veterans. It has not
associated any of our exposures with our health issues, and has
added little towards the development of effective evidence-
based treatments for Gulf War illness. The real weight is being
borne by Gulf War illness--Gulf War veterans who are suffering
from Gulf War illness. This new report recommends no further
research using animal models of Gulf War toxic exposures, which
amounts to rolling up the sidewalk on this promising avenue of
Gulf War illness research just when it's beginning to unravel
the underlying mechanisms of Gulf War illness and point to
treatment targets. And these new--and this now affects not just
non-VA CDMRP research, but VA research as well. In one section,
it points out that the VA hasn't reported critical data, but in
other, recommends ending research on a long list of health
conditions, despite long histories of them in Gulf War veterans
not reported by VA. While acknowledging Gulf War illness is a
1991 Gulf War signature condition, there were no Gulf War
illness researchers on this panel. It recommends a shift to
brain/body interconnectedness that departs from the scientific
opinion that effective treatments, cures, and--it is hoped--
preventions can likely be found. Instead, this is more like the
1990s, when VA and DoD officials, some of whom are involved in
writing this report, denied Gulf War veterans toxic exposures,
denied benefits, and failed to develop treatments or
preventions. And now VA and DoD have developed a clinical
practice guideline that goes back to the very darkest days of
the 1990s, authored by some of these same old names and ideas.
Despite VA public statements to the contrary, including to
this Committee, this guide for VA and DoD doctors is filled
with references to psychosomatic and somatoform disorders; 52
times, to be exact. Its primary recommendations for Gulf War
illness are cognitive behavioral therapy or talk therapy,
exercise, and psychotropic drugs. Suicidal ideation is listed
in the guide as a notable adverse effect for every single one
of those medications at a time when we have a suicide crisis
amongst veterans. VA has active Gulf War veteran studies on CBT
and exercise, but somehow still recommends them as evidence-
based in this definitive guide. Twenty-five years after our
war, VA has circumvented most of the aims of the 1998 laws
intended to help us. In addition to the above, VA lost its
registry--lost its registry--for Gulf War spouses and children;
ignored and then gutted the Gulf War Research Advisory
committee; misleads Congress in its reports to Congress; found
no link between Gulf War exposures in Congress, including in
these manuals; identified almost no new presumptives. If we
measure VA's success by how it's improved Gulf War veterans
health 25 years after the war, VA still has not a single
evidence-based treatment for Gulf War illness. Others among us
have died of ALS, brain cancer, and suicide. And only since the
Congressionally Directed Medical Research Program was enacted
through the support of many on this committee has VA even begun
to look at developing treatments. And while there is real
research progress, most of it is being made outside of and in
spite of VA in the CDMRP, thanks to many of your support.
Twenty-five years later, one-fourth to one-third of us Gulf War
veterans continue to struggle with the health and life effects
of Gulf War illness. We must not allow--we must not continue to
allow VA and DoD to substitute risk communication for evidence-
based health care, psychosomatic drugs for treatment-focused
research, spin for substance, or don't look/don't find for the
objective collection analysis and reporting of deployment
health outcomes. The letter, the spirit, and the intent of the
1998 Persian Gulf War laws that we fought so hard to win have
yet to be achieved.
And, again, this is just a brief overview. On this 25th
anniversary of the Gulf War, our Gulf War veterans deserve the
very best that modern science and the U.S. Government can offer
to improve their health and lives.
Mr. Chairman, as one of our Gulf War veterans and Members
of this powerful Committee, please join together and with your
colleagues on both sides of the aisle and in both Houses and
help fix these serious issues once and for all. My fellow Gulf
War veteran David Winnett and I look forward to your questions.
Thank you, again, for this opportunity.
[The prepared statement of Anthony Hardie appears in the
Appendix]
Mr. Coffman. Thank you for your testimony, Mr. Hardie.
Mr. Hardie, do you recall--and so when we talk about, first
of all, the duration of the war, that there were troops on the
ground in August of 1990, and then the fact is that the air
campaign, I think, started on January 27; ground war started on
February 24. But there was certainly contact prior on the
ground side with Iraqi forces. But there was--the term--was it
``blow in place''?--I think, is a combat engineering term--and
that there were chemical munitions--
Mr. Hardie. Yes, sir.
Mr. Coffman [continued].--that were blown in place that the
Department of Defense denied. Do you remember what the name of
the location was, primary location was, and the date--
Mr. Hardie. Yes. Mr. Chairman, it was in early March of
1991, after the end of the war. It was at a place called
Khamisiyah, and candidly, it was the only one of the incidents
that we Gulf War veterans were ever able to get DoD to admit
to. There were many others.
Mr. Coffman. But it took how long--it took--was it 5 years?
I can't remember. What was the time length that it took?
Because there was a coverup, quite frankly.
Mr. Hardie. Yes.
Mr. Coffman. Because there were--the page out of General
Schwarzkopf's log was missing on that day. All other records
were destroyed intentionally. They said they were--I can't
remember--accidentally destroyed. But they were destroyed
nonetheless. So there were no fingerprints. And the statement
by the Department of Defense was that no U.S. troops were
exposed to chemical--to any chemical munitions, chemical
weapons. We know that's not true today. Nobody faced
disciplinary consequences for lying. And then--and then so the
research never took that into account because the Department of
Defense denied that. How long did it take the Department of
Defense to finally acknowledge that U.S. troops had been
exposed?
Mr. Hardie. Well, Mr. Chairman, my understanding--my
recollection that it was about 5 years.
Mr. Coffman. About 5 years.
Mr. Hardie. About 1996. And, again, to emphasize, as you
just said, that was one of--that was the only incident that we
were successfully able to get DoD to acknowledge. And all that
information, that evidence, came from Freedom of Information
Act requests from a large number of veteran advocates out there
who did an incredible job of digging up and finding out what
DoD and VA and the CIA did not want to--
Mr. Coffman. What was the name of those pills we had to
take?
Mr. Hardie. Pyridostigmine bromide, sir.
Mr. Coffman. And they were not FDA approved. Is that
correct?
Mr. Hardie. That's correct. My understanding, though, is
that DoD has recently approved them now for use. And that's
extremely concerning, given the health effects that me and the
men in my unit had. I can't understand how that's even
possible.
Mr. Coffman. And what was the purpose? Was that for
biological or--
Mr. Hardie. So, sir, it was an anti-nerve-agent
prophylactic--
Mr. Coffman [continued]. Nerve agent. Okay.
Mr. Hardie. It was in order to help to improve the
survivability if we were hit with one particular nerve agent.
Although now research by Dr. White and others has shown that
this drug in combination with other chemicals is extremely
problematic and--for health, and causes Gulf War illness-like
symptoms in laboratory animals. The kind of research that the
IOM report recommends ending.
Mr. Coffman. And then Saddam Hussein had blown a lot of the
oil wellheads to obscure, I think, his own movement or
positions of his troops. And then, of course, through our own
bombing efforts probably destroyed the balance to where there
were days, I remember a wall of black smoke would be coming at
you. And you were literally engulfed in that oil well fire.
Smoke emanating from those oil well fires for very long periods
of time. Do you feel that that's been adequately researched in
terms of what the health effects of that were?
Mr. Hardie. Mr. Chairman, I don't feel that any of it has
been adequately researched. I think the VA has done an
atrocious job. I think that many of the--there's a long list of
conditions in the 1998 laws that were supposed to be--VA was
supposed to contract with IOM for. Many of those were never
researched, including low levels of mustard, which we know was
in the January 19 plumes drifting over the troops. The studies
of sarin failed to connect illness in animals exposed to sarin
with human health outcomes. That's extremely problematic. And,
of course, these days, we're not putting human beings into a
gas chamber exposing them to a deadly nerve agent like sarin.
So there's this impossible, impossible standard that has
prevented the 1998 laws from ever being achieved. Again, I
don't believe any of the substances have been adequately
researched or in the right ways.
Mr. Coffman. Have you--this is my last question. Have you
uncovered at all why the command senior leaders, they chose to
destroy those chemical weapons there as opposed to properly
dispose of them?
Mr. Hardie. That's a more complicated question, sir. I
don't have--I have my own beliefs. But I don't have a good
explanation. I do say that it's extraordinarily disappointing,
particularly that those logs--General Schwarzkopf's logs
disappeared. I served in an intelligence role in the 1991 Gulf
War and kept logs of my own, which have never been able to--
have been found. My entire unit's medical records have--I'm
sorry. Our medical records disappeared. It took a year for our
personnel records to show back up as well. And there were a
series of chemical incidents, including one nearby to where I
was located, where we were--the messages that I was logging
were that chemical warfare agents were detected, were
confirmed, were confirmed again, and then suddenly it all went
away. And the evidence that Gulf War veterans uncovered through
Freedom of Information Act requests showed that over and over
and over again, the DoD, the CIA, and the VA have all fought
all of that across the board. And what we--and it's very clear
to all of us. We came back home sick. Twenty-five years later,
we've got a stack of volumes that hasn't helped us. We need to
do better.
Mr. Coffman. Mr. Hardie, thank you so much for your
testimony.
Ms. Kuster, you are now recognized.
Ms. Kuster. Thank you, Mr. Chair.
And thank you, Mr. Hardie, for your service, and, Dr.
White, for your reach, and to the whole panel for being with us
today.
I'm just thinking of my own personal experience, not in
wartime, but I had an illness that was connected with ingestion
of volcanic ash. And I was very sick for a very long time. And
so my empathy is with you and the veterans exposed to a
substance like that, that you don't know, I learned later that
it was really ground glass, and when it gets into your lungs,
you do get sick. But it was that same feeling of the cloud
coming toward you and the helplessness of not--not being able
to protect yourself. So my goal here is two-fold. One is to
make sure that we have a sufficient understanding to help the
veterans from the Gulf War era. And, number two, and equally
importantly for me, that we have an understanding to protect
our servicemembers who are currently serving abroad.
And so my question, and I'll just put this out to Mr.
Hardie and Dr. White, but if anyone else wants to weigh in,
have we--I understand your frustration. And I'm just wondering,
have we made any progress? Are there individual instances? Are
there anecdotal stories of treatments that have been effective
that could be more widely used? Let's start with that.
Mr. Hardie. Maybe if I go first and then Dr. White will
have probably other things to add as well. But so there is hope
through the efforts of many here in this room, including, thank
you, Dr. Roe and Mr. Walz for your leadership in--with the
Congressionally Directed Medical Research Program, and for many
of you who have signed on in support of that program. It was
created in fiscal year 2006, and has shown great progress. But,
again, outside of and in spite of the VA, which is now doing
some good things thanks to the work of Dr. Kalasinsky, but has
a long, long, long ways to go. About a third of the studies
funded through this program are testing actual treatments that
might help the health and lives of ill Gulf War veterans. The
other two-thirds are studies that are aimed at Gulf War
illness' underlying mechanisms. They include critically
important animal studies that test exposures and measure health
outcomes, again, the kinds of things that are now threatened by
this IOM report. They identify treatment targets. They test
treatments. There are three that have--three treatments--again,
much of this is still in the pipeline, but there are three that
have been shown to be effective in limited numbers as well:
Coenzyme Q-10, carnosine and acupuncture for pain. I take CoQ10
every day. It helps me in a--it helps me a great deal. It's not
a cure, but it certainly makes a difference. I've heard the
same from other Gulf War veterans. I'm pleased to hear that now
we have this study coming from--that will advance it. But,
again, it's not a cure. I take it every day. And I can tell you
that we have a long--we have--but we're making the progress now
through this program. And we hope that VA would finally get
onboard with making the systemic changes that need to happen,
including in its badly broken Office of Public Health.
Ms. Kuster. So one of the things we're going to be doing a
hearing, a regional hearing, of this Subcommittee actually
coming to New Hampshire to talk about opiate use and some
interesting research that's going on in White River Junction
VA, to bring down the use of opiates using alternative
remedies, acupuncture, mindfulness, some of the things that
you've mentioned, because I do believe in that mind/body
connection. And I don't mean to diminish anything about it. I
know that there's certainly illnesses, thyroid illnesses, that
type of thing, where it is so closely connected. So I think
it's worth exploring these other treatments. And I guess--and
because I agree with you that just throwing pills at it,
throwing, you know, psychotropic medication that have these
down sides with certainly suicidal ideation, et cetera. But
just going forward, I'd love to talk with you all about--we're
going to be looking hopefully at legislation about best
practices in the VA on pain management. Maybe there's a way to
bring in some of this research that has gone forward.
And I'd just--Dr. White, I have a very brief time left, but
if you have any comments.
Ms. White. I would say that there's a number of lines of
treatment approaches that have been supported by CDMRP and more
recently VA through our recommendations and work with them on
the Research Advisory Committee. Some are aimed at symptoms,
brain activation, improving general health and wellbeing.
Obviously, when chemicals affect the brain, they affect how you
feel as well as how you think and your immune system. And it is
a whole body thing. I think what we're trying to say is that
there is physical damage to the brain that is causing emotional
as well as cognitive and other symptoms. And you need to
approach the whole package. One thing that I think is really
wonderful about the support we have gotten for the CDMRP
programs, and I'm on the integration panel for that, is that we
are now working on therapies and trying to fund therapies that
get to the neuro-inflammatory and mitochondrial basis of this
disease. If we can find treatments that go after the neuro-
inflammation, that go after the mitochondrial damage, that go
after some of the mechanistisms underlying pathophysiology of
this illness, we will not only help the Gulf War veterans,
we'll help other people with exposures in the whole world. And
these kinds of chemical exposures are very hard to treat, as
you know from your own illness. So I think that there's so much
promise in the mechanistic-based treatment, as well as the
symptomatically focused treatment. I would hate to see that
lost. We're finally getting to mechanism. And we were not
anywhere close to that 10 years ago.
Ms. Kuster. No, and I need to yield back. But I agree. And
the other half of my question, I--we won't get into it here,
but I am extremely concerned that we get upstream on
understanding the exposure, because, obviously, you know, I
don't have to tell my colleagues that war is a dirty business.
But at least we can do our best to protect our troops from
smoke and inhalation and that toxic exposure.
So, thank you, Mr. Chairman, for your indulgence.
Mr. Coffman. Thank you, Ranking Member Kuster.
Dr. Roe, you're now recognized for 5 minutes.
Mr. Roe. Thank you, Mr. Chairman. And for the group here, I
don't know whether you know or not, but I've sponsored a bill
called the Desert Storm and Desert Shield War Memorial Act. And
we're in the process of--hopefully I'm meeting with Scott Stump
in just a little while this week--I think sometime this week--
to talk about how we raise funds for that. But we wanted to do
that while it was still on everyone's mind and people forgot
about it.
I think the question that I have, and as a scientist, and
it makes a difficult when you don't know the etiology of a
disease, it's very difficult. You end up treating symptoms. And
they may vary. And I found that one of the great things that
used to really bother me when I was in practice was, if we
didn't know what was wrong with you, we either said it was a
virus or you were nervous. I mean, that's basically what you're
doing. And I hope we're not doing that here. I don't think so.
I think good, honest people looked at the data. I think it's
very, very hard to assimilate this.
And the question I have for anybody on the panel, have you
looked at the oil workers who put the fires out? Have we looked
at the cohorts there in Kuwait? Right now, there are people
that still live in Kuwait that were there. Did they have these
symptoms? Is there--are there--when we looked at the cohort who
were in the service but weren't deployed versus the ones who
did--now, I think the Institute of Medicine did that. I think
that's the cohort they looked at. You have a built-in group of
people right there in Kuwait who were there during the war in
Iraq. And has anyone who served in the current conflict in
Iraq, now that it's been--we've been out of there for a while,
have they had any symptoms? A lot of questions.
Ms. White. Well, to answer some of your questions, the--
there have been studies on subgroups of people within the Gulf
theatre who had very specific kinds of exposures. So there is a
bunch of research out on the pesticide applicators. And we know
a lot about what pesticides they were exposed to, how much,
what it did to their health. There is a study that's being done
at Harvard that I'm participating in on the Kuwaiti population.
They do--the people that were there then do have increased
symptoms. We're trying to figure out what it means because the
surveys that they used and so on didn't exactly address it the
way we would address Gulf War illness.
The other point I want to make is that the exposure
scenario in the Gulf War theatre was very complex. And
comparing deployed to undeployed veterans does not always tell
you what happened to people who were in specific places with
specific kinds of high exposures. So the standard that we tried
to ask for on the Research Advisory Committee (RAC) and in the
Cortex paper that I just wrote is looking at people within--who
were deployed to the Gulf and who were exposed versus who were
not exposed and who were in certain locations.
Mr. Roe. Well, I was going to say, because I know probably
the Chairman, when you're in the military, sometimes you don't
know where you are. I know that I have been deployed in places
I didn't know where I was. And I've--as a matter of fact, I've
asked that question. Where are we? I mean, so are you able to
pinpoint--that's a great point you made. Can you do a sort of a
spotogram where these folks were? Because you're right: being
deployed a hundred miles up here might not be the same as being
deployed next to a chemical burn.
Ms. White. Yes.
Mr. Roe. No question that's true.
Ms. White. So where that data came from, and I used a lot
of this data when I was head of an environmental hazards center
that was funded by the VA, was we asked for data on what troops
were where. And we got troop level data on locations in the
Gulf. And we used that for some of our research. That's how we
knew who was in the area of the Khamisiyah detonations and
certain other things. So, yes, those data are there. It took a
lot of years to get it because it was in paper in a warehouse.
But there are data on who was where, at least at the troop
level.
Mr. Roe. At least that's where they think they were
supposed to be.
Ms. White. Yes, because not every individual was where
their unit was supposed to be.
Mr. Roe. You get--when you get shot at, you're not
necessarily where you're supposed to be. You move from that
place.
So I guess what I'm--the last question--my time's about
expired. But, again, I thank all of you because this is one of
the most difficult epidemiologic issues I've ever looked at.
Because, again, in--like in Ebola, we knew what caused Ebola.
In other diseases like that, where there's a single agent, you
can--we know what a--how that goes. We know exactly what an
epidemic is going to do. We followed them for centuries. We
know what they're going to do. This is much more difficult
because you haven't identified a single agent or multiple
agents. Or maybe there were one agent here and somebody else is
over here so--and did the treatment contribute to it? I mean,
did giving the soldier something to prevent it do anything? So
I admire you for trying this. This is one of the most different
epidemiologic studies I've ever seen.
So I yield back.
Dr. Clancy. The only thing I would say very briefly is, I
mean, I think it's a particular challenge for a chronic ongoing
kind of condition, which is different than a sort of acute
epidemic, the way that you've described.
The other thing that I would say is, I don't think that we
should discount the progress we've made. Cancer would be a
perfect example, right, where we've learned a lot through brunt
empiricism, because we didn't understand underlying etiology,
but we tried a whole lot of treatments first and eventually
made a lot of progress.
Mr. Coffman. Thank you, Dr. Roe.
Sergeant Major Walz.
Mr. Walz. Thank you, Chairman, and I thank you all for
being here. I think I'll dovetail on that, Dr. Clancy. First of
all, thank you for the update on the step pain management plan.
I think it's important information with the hearing that's
going to be next week up in New Hampshire with Ms. Kuster that,
back in 2007, this very issue was out there, and I think great
strides were made, and I think you have much to add to the
conversation because this is not a VA issue of opioid use and
pain. It is a societal issue. So I appreciate that update.
And I think, going back to what you said, I do think you're
right on that. I think much progress was made on some of these
very difficult ones. Dr. Roe clearly laid out the epidemiology
and the challenge of this.
My concern is, though, when do we make a decision that
we've tried hard enough or that we've reached that point,
because I think the frustration lies in this that I think
many--something's happening, and again, we have to have the
data, but there's something happening. There's enough people
reporting it. All of us are hearing this, and I just wonder--
you have to make tough decisions about where funding sources go
and where those types of things happen. I think there's belief
of many of us that this is going to be difficult, but we have a
responsibility to keep going on it.
How do you make a decision--``you'' being the VA, if you
can speak for that--how do you make a decision on how hard you
push on a certain area or how much you do in the research?
Dr. Clancy. So let me just say, having run a research
agency for quite a few years at HHS, this is one of the
toughest kinds of decisions to make, and it's really an
investment question, right, where do you place your bets in
terms of getting to rapid answers and the kind of evidence that
you want, and there's no biblically correct strategy in terms
of rules to guide you.
The one recommendation I--the very top line recommendation,
and I want to emphasize that we've not had a chance to go over
this Institute of Medicine report. It's still--the ink is still
drying, so to speak. It's actually a prepublication version, I
think, we're all looking at, and so forth, and are looking
forward to going over it with our Research Advisory Committee
very, very carefully. But the notion that we would develop a
cohesive, coherent plan with the Department of Defense and,
frankly, inviting others, like the Harvard study that Dr. White
referenced and so forth, to find out--to really push very hard
on this question.
There's a huge proportion of people who were deployed for
these two operations, and we don't have any answers. We have
some promising signals, and that's exciting. I think some
additional genomic studies, as a paper that I'm looking at from
Dr. White has pointed out, may help us even more, but that's
not coming up with an answer for why our almost a third of
these soldiers deployed are struggling.
So I think that this is going to be a tough answer to come
up with and a tough strategy to come up with, but it's one that
we'd be looking forward to giving you full answers on.
The last thing I would say is, the number I gave you is a
very, very conservative estimate because it doesn't count our
epidemiological studies. It doesn't count the investments we've
made in registries, for example, the Gulf War registry, the
burn pits registry, and so forth. And so we're investing more
than that, but the question is, have we done enough? And I
think the answer to that is no.
Mr. Walz. No, and I appreciate that because I do think you
got on it, too, that the broader issue--I think many of us who
have followed the issues on Agent Orange, and there's Vietnam
veterans sitting in this room that have pushed on this.
Dr. Clancy. Sure.
Mr. Walz. They're concerned on the genetic defect issue of
how many generations down the line, you know, beyond spina
bifida of what's happening to these children, what's happening
to the grandchildren, that's going to come to this, the burn
pit, the depleted uranium.
So my question is, are we doing enough? I mean, shame on us
if we're not learning that every generation has to come back
and fight the fights on these things. Is now the time for a
center of excellence on toxic wounds? Is this the time to do
that? Does that make the difference, where it brings the force
of all of these issues under one? Because the thing I worry
about is--I don't want to put Parkinson's research on Agent
Orange exposure against Gulf War exposure. And I know you may
tell me that's the choices we have to make, the hard ones. So I
ask you, is the center of excellence the way to go to bring
this under one in-house?
Dr. Clancy. You know, it may be, and we would love to work
with you on that, because no matter when we called it--because
I agree with you about the X amount here, Y amount there, who's
made the most noise recently, to be crass.
Mr. Walz. Yes. No, I think that's a true statement, though.
Dr. Clancy. No matter how you cut it, it's going to have to
be an entity that coordinates what we're doing with Defense,
with what's going on at HHS, and from a variety of other
funders, which would be great, actually, because--but I think
we can leverage all of that. We've recently been working with
CDC's agency for toxic substances and diseases on the Camp
Lejeune issue, and actually, that was very, very productive.
Mr. Walz. And I think our issue, especially with these
toxic wound exposures in battle, it differs from cancer in that
the private sector is not investing as much in this because
there's--
Dr. Clancy. Right.
Mr. Walz [continued].--not--it's a limited universe that's
going to be treated by this. So, once we treat them, which we
need to do, and cure them, there's not a market for the product
necessarily.
Dr. Clancy. Exactly.
Mr. Walz. That may be crass, too, but that's the reality of
the economics. But, no, I thank you all for that, and I think
the commitment here is, is that something happened to these
folks. It's real--
Dr. Clancy. Yeah.
Mr. Walz [continued].--and they deserve an answer and a
treatment.
So I yield back.
Mr. Coffman. Thank you, Sergeant Major Walz.
Mr. Huelskamp.
Mr. Huelskamp. Thank you, Mr. Chairman.
I appreciate the topic of our hearing today. I'm hearing a
lot of contradictory claims and concerns and maybe a
conclusion. I want to direct a couple of questions to Dr. Hunt,
who I don't think has had an opportunity to participate today
on the question and answer, but based on the tenor of a
relatively recent presentation you gave called, ``A Model for
Providing Services for Returning Combat Veterans,'' it's
apparent that, and you others in the VA believe Gulf War
illness is a mental disorder. Is that correct?
Dr. Hunt. That is not correct. I'm not sure where you got
that information.
Mr. Huelskamp. Did you not have a presentation entitled ``A
Model for Providing Services for Returning Gulf War Veterans''?
Dr. Hunt. Presented where?
Mr. Huelskamp. I don't have that, the place of
presentation.
Dr. Hunt. I don't believe that, and I have never said that,
and I don't--no.
Mr. Huelskamp. So this wasn't your presentation then?
Dr. Hunt. It could be. I would have to look at it. I'm not
sure.
Mr. Huelskamp. Okay. Well, I don't know. You never made a
presentation on ``A Model Providing Services for Returning Gulf
War Veterans''?
Dr. Hunt. I give presentations on that often.
Mr. Huelskamp. All right.
Dr. Hunt. But I would like to see it because it certainly
is a misinterpretation of what I believe and, I suspect, what I
said.
Mr. Huelskamp. So do you believe also or otherwise that
psychiatric drugs are the best treatment for veterans with Gulf
War illness?
Dr. Hunt. I believe that medications should be used for
conditions they're indicated for, and psychiatric medications
are not indicated for Gulf War illness, per se.
Mr. Huelskamp. What kind of treatments would you suggest
then?
Dr. Hunt. I think the most--25 years ago, what was going on
with me was, I was starting to see people coming back in 1992
and 1993, coming back from the war, and the things that they
were saying when they came back were not, ``I have Gulf
syndrome'' or ``I have a mystery illness.'' What they were
saying was: ``I'm not doing very well. I'm having a lot of
trouble. I'm having trouble at home; work's not going well. I
can't do my PT for Reserves--Guard and Reserves,'' and so on.
And our response to that was to set up a clinic for
returning combat veterans that really was looking at the
various ways that the deployment impacted their health: how it
impacted their health physically; how it impacted their health
psychologically, emotionally, spiritually; how it affected
their families. And we came up with a model of integrated care
to support Gulf War veterans. It became the Gulf War Veterans'
Clinic.
That eventually morphed into what we call in the VA
Deployment Health Clinics, or turned into what we call a Post-
Deployment Integrated Care Initiative. I have never--the first
veterans that came back, I would not have said, ``This is in
your head,'' or ``I think this is a mental condition.'' I would
have said: ``You're having trouble. I don't know exactly what
all is going on, but I know you've been off to war. I know
you've been exposed to a lot of things. I know you've had some
very difficult experiences, and let's see what we can do to get
you back on your feet.''
I've had an eye on two things. One is the sort of research
that Dr. Golomb and Roberta and Lea Steele have been trying to
do to figure out what's the cause of this Gulf War illness
that's very discrete. Clearly, we have higher rates of these
symptoms and this problem in Gulf War veterans than any other
cohort I've ever seen.
The research is important. At the same time, we had to have
a way of helping people, and so our clinical focus has been:
How can we help you get back on your feet? By providing you
with integrated--good integrated care that includes symptom
management, that includes medications when they're appropriate,
that includes--
Mr. Huelskamp. Are the psychiatric drugs most effective,
you believe, or what have you seen in--
Dr. Hunt [continued]. I think the most effective thing is
good health care, is appropriate evaluations and treatments for
diagnosable conditions, getting people resources they need
through service-connection. This is the first time we've given
service-connection--
Mr. Huelskamp. Excuse me, sir. That's general. I'm asking
you about psychiatric drugs. Are they effective in the
treatment or not?
Dr. Hunt. They are effective in the treatment for indicated
conditions. If a person--one of the problems we had--and
Anthony, I was thinking about this when you were talking as
well--if--because of the suicide issue, if we see Gulf War
veterans that have unexplained symptoms or Gulf War illness,
they may also have concurrent or co-occurring depression, and
they are at risk for suicide, and so it's very important that
we don't look at this as either/or, and if a person has a
mental health condition, that they get appropriate treatment,
which--
Mr. Huelskamp. My concern is, it seeks like the psychiatric
drug approach seems to be where--the simplest choice for the VA
to make.
Dr. Hunt. I would not say that.
Mr. Huelskamp. And I appreciate--
Dr. Hunt. I would not say that.
Mr. Huelskamp [continued].--you disagreeing with that.
The last thing, I want to ask a question of Dr. Cory-
Slechta. In your recommendations, you do suggest no further
studies should be undertaken on cause-and-effect relationship
because you don't have definitive and verifiable individual
veteran exposure information. Is that correct? Is that your
recommendation?
Ms. Cory-Slechta. There were no measures made of internal
exposures of veterans, and there were no measures made even of
environmental exposure levels. This is basic principles of
toxicology and pharmacology.
Mr. Huelskamp. So, in your opinion, then--and I understand
that. In your opinion, then, all the previous studies that
attempted to determine that, are they invalid then?
Ms. Cory-Slechta. I don't think you can rely on self-
report, because there will be people who were actually exposed
who don't even know it.
Mr. Huelskamp. This is not about self-reporting. It's
whether you have definitive or verifiable individual veteran
exposure.
Ms. Cory-Slechta. I think it's possible to get those kinds
of measures, and that's what I stressed before, that in the
future, we need biomonitoring devices and GPS tracking devices
so we can in fact get that kind of information and make those
associations.
Mr. Huelskamp. And I understand that. I'm just trying to
figure out whether you thought we had that in the past, and to
me, that calls in question a number of these studies, if we
don't have that type information.
Lastly, you did request additional studies of sex-specific
and race/ethnicity-specific health conditions. If we don't have
the individual exposure information, how do we determine--
Ms. Cory-Slechta. Well, there may be--we know a lot of
diseases and disorders differ in their manifestations by sex or
by race/ethnicity.
Mr. Huelskamp. If we don't have the exposure information,
which is a key variable, how--
Ms. Cory-Slechta. It's a different point.
Mr. Huelskamp [continued].--do you study that?
Ms. Cory-Slechta. It's a different point. The exposure
information, what this committee has said is that we'll never
be able to understand how those exposures actually related to
these health outcomes. We don't have any objective exposure.
Mr. Huelskamp. We don't know whether they have exposure or
not is your point.
Ms. Cory-Slechta. Sorry?
Mr. Huelskamp. We don't know whether they have exposure or
not. Is that the answer?
Ms. Cory-Slechta. We know there were exposures. What we
don't have is actual information for individuals that we would
look at it in relation to health outcomes.
Mr. Huelskamp. I understand. So--
Ms. Cory-Slechta. We know there were exposures.
Mr. Huelskamp [continued].--So I don't know how you do your
second round of studies that you recommended. You say abandon
the first round, but the second round, you're talking about
race and sex and--
Ms. Cory-Slechta. We're just saying for any health
outcomes, because oftentimes, for many different diseases and
disorders, there are manifestations, and sometimes their
mechanisms differ by sex and by race/ethnicity. In order to
really understand and/or treat them, you may be doing it very
differently. Heart attack is very different in a man than in a
woman, for example.
Mr. Huelskamp. Yeah.
Ms. Cory-Slechta. So we need to break those out and look at
them.
Mr. Huelskamp. Thank you, Mr. Chairman. I just found it
concerning that the basic exposure information is--we're
hearing that, well, we don't know what it is, and so if you
take that variable out, I mean, that strikes out a lot of
information, a lot of data, and a lot of research would be
thrown out by the Institute of Medicine, and we spent a lot of
time, attention, and money trying to figure this out, so very
concerning.
I yield back.
Mr. Coffman. Thank you, Mr. Huelskamp.
We'll have one more round if anybody else has questions. I
do have two questions.
Mr. Winnett, could you join us at the table?
Mr. Winnett. Sure. Can I get a bottle of water first? I
just took a Vicodin. Hard to take those on a dry mouth.
Mr. Coffman. Mr. Winnett, on your Facebook group related to
Gulf War illness, you asked: How many veterans are being
referred for psychiatric or psychological treatment?
What kind of response are you getting?
Mr. Winnett. In a word, overwhelming, sir. Can you hear me
okay?
Mr. Coffman. Is that on, microphone on?
Mr. Winnett. In a word, the answer to that question,
Congressman, is overwhelming. I might add that, yesterday, we
hit the milestone of 10,000 veterans. This is a closed group,
and I approve every member and have so for over the last 7
years. Overwhelming. And my written statement for the record
includes quite a number of them, but obviously not all of them,
but it took some of those that were very compelling, and I
think they are self-explanatory if you read my statement as to
what the prevailing attitude is about VA's treatment of Gulf
War illness.
Mr. Coffman. Thank you.
Now, Mr. Binns, could you please come to the table? Mr.
Binns, given VA's use of IOM reports in the manner we have
discussed, are you aware of any requirements for such reports?
Mr. Binns. Yes, I am. The Congress ordered these IOM
reports, and in the law, it specified very clearly what it
wanted the IOM reports to consider. It listed 33 toxic
exposures, including all the ones that have been mentioned
here, and it asked whether in the medical literature, there was
an association between any of those toxic exposures and illness
in humans or in animals.
Congress did not ask whether there was data on the
individual exposure levels that troops received because it was
known, at the time the law was passed, that that information
was not available, but it did want to have the information on
animals, because most studies of toxic substances are done in
animals.
When VA contracted for these studies, however, they did not
contract for considering animal studies. And the Institute of
Medicine was a willing accomplice in that it removed
consideration of animal studies from its standards of evidence,
which it had used in the case of Agent Orange evaluations for
Vietnam veterans. So the action taken was exactly the opposite
of what Congress ordered, and as a result, that entire stack of
reports, which you see, no IOM report has ever considered
animal studies in its conclusions, and no IOM report has ever
found an association between a toxic exposure and the illnesses
that we're talking about today.
And I want to just clarify, because there has been a lot of
discussion today about how complex this is. And, certainly,
going forward, it is complex to find treatments, but well
worthwhile. But what is not complex is understanding why these
veterans are ill. You do not have to measure each veteran and
have a monitor on them to know that.
Our report, the report of the Research Advisory Committee
that was done in 2008--here it is--it researches very firm
conclusions on the fact that these illnesses were caused by
toxic exposures, notably the ones Dr. White mentioned, PB and
pesticides. There is no dispute about that if you consider
animal research. But the IOM has never considered the animal
research. They talk about it, they have paragraphs on it, but
when you reach the conclusions, they use a standard of evidence
which excludes animal studies.
Please read my submission, and you will see that in detail
that the entire IOM reports--if you read the reports, they're
very clear. They're very honest. They say: We don't consider
these animal studies. And we're talking about basic things
here. Here's 2 pages with 23 studies of the effect of low level
sarin, such as was experienced in Kamasia that was considered
by the Research Advisory Committee and has never been
considered by the IOM.
Dr. Cory-Slechta's report on page 139 says that she didn't
consider the animal studies because they were relying on
earlier IOM reports. Well, if you read the earlier IOM reports,
as I indicated in my written submission, they didn't consider
them either. These are the basic studies that say the toxic
substances are toxic.
So the whole IOM series of Gulf War and health reports is a
stack of cards, and the same dishonest standard is being
applied to current veterans of Iraq and Afghanistan who have
been exposed to burn pits. Once again, there is no
consideration of the standard that Congress itself established.
Mr. Coffman. Thank you, Mr. Binns.
Ranking Member Kuster, you are now recognized for 5
minutes.
Ms. Kuster. Yeah. Thank you.
This is a question for Dr. Clancy. And, again, my exposure
and my experience doesn't compare to anyone serving in wartime,
but part of the complication that I experienced with my lungs
was, I was told that I had the lungs of a 90-year-old smoker.
And I've never smoked a day in my life, and I consider myself a
healthy person, but that's the kind of damage that can be done.
I'm much better now. But I'm curious--and this goes to Dr.
Clancy, maybe Dr. Hunt--on the long-term impacts--well, we know
from the IOM and just generally that cancers have a long
latency period, 20 to 30 years in the case of lung cancer. This
is a quote from the Lung Cancer Alliance, from the written
statement: The median age for cancer diagnosis in the United
States is 65, 70 for lung cancer, and the median age of Gulf
War veterans, 1991, was 28. So, add 25 years, we're coming up
on this cohort of veterans being 50 years or older, and I'm
wondering, is there any action being undertaken by the VA--or
could we encourage you to do that--where we would be providing
lung cancer screening to Gulf War veterans that we have on the
registry, or at least an initiative VA-wide, where we would put
the word out for Gulf cancer veterans to get this type of
screening? Can you tell me the status and just what that would
look like and how we can move forward?
Dr. Clancy. So, just to be clear, we have pretty well
developed cancer registries for most of the major cancers, and
I think the Institute of Medicine report was very clear that
that would probably be the most fruitful place to identify an
increased incidence.
We could certainly explore lung cancer screening for some
of these folks, and I actually think that's a very intriguing
idea. About 60,000 people have voluntarily signed up to enroll
in the burn pits registry. The only caveat--but again, I think
this will be interesting to learn. The lung cancer screening
studies were done on smokers. Whether it will be as productive
in identifying early nodules and so forth in people who have
lung damage for another reason is an open question.
Ms. Kuster. Yeah.
Dr. Clancy. I will say it's something the VA has been
looking at for a few years, not just can we get veteran
screening, but also can we do the appropriate follow-up,
because the price tag on reducing mortality rate for lung
cancer is the only thing we've got, right, is this new kind of
screening; it reduces mortality by 20 percent. Nothing else
we've ever done works like that.
Ms. Kuster. Yeah.
Dr. Clancy. The flip side of it, though, is you have a lot
of false positives, so people need to be followed up very, very
carefully, and we've been looking into that for several years.
Dr. Hunt. The other important thing for the Committee to
know is that our approaches to more proactively addressing
exposure concerns following deployment are sort of demonstrated
very clearly through the airborne hazard and open burn pit
registry. Now, when folks come back from Iraq and Afghanistan,
they can go online; they can document their symptoms, their
concerns, their exposures. It goes into the clinical record.
They come in, and they have an exam, so we're really starting
the moment people come back to look at potential sequelae.
Ms. Kuster. So maybe what we're talking about then would be
to take that approach and go back to the Gulf War veterans to
bring them in to that. And I understand we don't have the
specificity. I get the frustration--
Dr. Clancy. Yeah.
Ms. Kuster [continued].--from the science side of wanting
to know, but I also feel that people have had exposure, and
without even knowing the specificity, at least we would have an
understanding. A 20 percent drop in mortality is significant,
so--and I just want to associate myself with the remarks of Mr.
Walz that maybe that is the approach that we need, is a center
of excellence for toxic exposure, toxic wounds. And I also
think that, once again, the VA could be on the cutting edge for
the civilian population in terms of understanding our exposure
to all kinds of toxic substances.
Dr. Hunt. And that's why engaging people in care is so
important, too, because the best way to pick up malignancies is
to have people involved in regular care so--
Ms. Kuster. Right.
Dr. Hunt [continued].--So prescribed screening occurs, and
so we--if people have symptoms, we're more likely to pick up--
pick things up more quickly.
Ms. Kuster. Right. And I think that, this way, you can
bring people back in and, through their regular care, have the
conversation about, we would recommend--and I understand, look,
CTs for everybody in the world is going to be expensive, but to
me, it's very important that we show that kind of care and
concern.
I wasn't in Congress 25 years ago. I regret that people
were treated this way, and I think we have a bipartisan support
here to do better going forward. And, again, thank you for your
service and, for all of you, for your interest today.
Mr. Coffman. Thank you, Ranking Member Kuster.
Our thanks to the witnesses. You are now excused.
Today, we have had a chance to hear about the problems that
exist within the Department of Veterans Affairs with regard to
treatment of and current health outcomes for veterans suffering
from Gulf War illness. The lack of progress that has been made
by the Department in the 3 years that have passed since many of
these problems were highlighted by this Subcommittee is both
frustrating and disconcerting.
I believe Gulf War veterans deserve better, so I will be
exploring options on how to best address these matters in the
coming weeks.
I ask unanimous consent that all Members have 5 legislative
days to revise and extend their remarks and include extraneous
material.
Without objection, so ordered.
I would like to, once again, thank all of our witnesses and
audience members for joining in today's conversation.
With that, this hearing is adjourned.
[Whereupon, at 5:58 p.m., the Subcommittee was adjourned.]
A P P E N D I X
----------
Prepared Statement of Deborah Cory-Slechta, Ph.D.
Good morning, Chairman Miller, Ranking Member Kuster, and members
of the Committee. My name is Deborah Cory-Slechta. I am a Professor of
Environmental Medicine, Pediatrics and Public Health Sciences, and
Acting Chair of the Department of Environmental Medicine at the
University of Rochester School of Medicine. I served as the Chair of
the Committee on Gulf War and Health, Volume 10: Update of Health
Effects of Serving in the Gulf War of the National Academies of
Sciences, Engineering, and Medicine. The National Academy of Sciences
was chartered by Congress in 1863 to advise the government on matters
of science and technology and later expanded to include the National
Academies of Engineering and Medicine.
The Institute of Medicine (IOM), part of the National Academies of
Sciences, Engineering, and Medicine, released its 10th report on Gulf
War and Health on February 11 of this year. The committee that I
chaired was asked to review and evaluate the scientific and medical
literature regarding associations between illness and exposure to toxic
agents, environmental or wartime hazards, or preventive medicines or
vaccines associated with Gulf War service and to pay particular
attention to neurological disorders (e.g., Parkinson's disease,
multiple sclerosis, amyotrophic lateral sclerosis, and migraines),
cancer (especially brain cancer and lung cancer), and chronic
multisymptom illness (also known as Gulf War illness). Volume 10
updated two earlier Gulf War and Health reports, Volume 4, published in
2006, and Volume 8 published in 2010. The committee made
recommendations for future research on Gulf War veterans. I should note
that the committee was composed of experts in neurology, epidemiology,
pain, psychiatry, neurocognitive disorders, environmental health and
toxicology; and clinicians and researchers, none of whom received
funding from Gulf War illness research programs.
For the most part, the Volume 10 committee followed the approach
used by earlier committees. It held two public sessions at which it
heard from representatives of VA, several Gulf War veterans and veteran
service organizations, Gulf War researchers, and representatives of the
VA Research Advisory Committee on Gulf War Veterans' Illnesses. The
committee did not address policy issues, such as service connection,
compensation, or the cause of or treatment for Gulf War illness. The
committee conducted an extensive literature search and reviewed the
Volumes 4 and 8 primary and secondary epidemiologic studies and the
conclusions reached by those committees. Other types of studies-such as
animal toxicology, neuroimaging, and genetics-were also considered.
Primary studies had to be published in a peer-reviewed journal or
other rigorously peer-reviewed publication; demonstrate rigorous
methods (for example, have an appropriate control group and include
adjustments for confounders); include information on a persistent (not
acute) health outcome; use appropriate laboratory testing, if
applicable; and have a study population that was generalizable to and
representative of the Gulf War veteran population. Secondary studies
were those studies that did not necessarily meet all the criteria of a
primary study. Many of the secondary studies relied on self-reports of
various diagnoses rather than an examination by a health professional
or a medical record review.
The committee used the same categories of association relating
health conditions to Gufl War deployment as used by previous Gulf War
and Health and other IOM committees that have evaluated scientific
literature, that is:
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 Exists
Limited/Suggestive Evidence of No Association
The committee found that in spite of the many millions of dollars
that have been spent on researching the health of Gulf War veterans
there has been little substantial progress in our understanding of
their health, particularly of Gulf War illness. The Volume 10 committee
found little evidence to warrant changes to the Volume 8 conclusions
regarding the strength of the association between deployment to the
Gulf War and adverse health outcomes. Veterans who were deployed to the
Gulf War do not appear to have an increased risk for many long-term
health conditions with the exceptions of PTSD, Gulf War illness,
chronic fatigue syndrome, functional gastrointestinal conditions,
generalized anxiety disorder, depression, and substance abuse. The
committee's conclusions are briefly summarized in the Box 1.
BOX 1
Summary of Conclusions Regarding Associations Between Deployment
to the Gulf War and Specific Health Conditions
Sufficient Evidence of a Causal Relationship
Posttraumatic stress disorder (PTSD)
Sufficient Evidence of an Association
Generalized anxiety disorder, depression, and substance abuse
(particularly alcohol abuse)
Gastrointestinal symptoms consistent with functional
gastrointestinal disorders such as irritable bowel syndrome and
functional dyspepsia
Chronic fatigue syndrome
Gulf War illness
Limited/Suggestive Evidence of an Association
Amyotrophic lateral sclerosis (ALS)
Fibromyalgia and chronic widespread pain
Self-reported sexual difficulties
Inadequate/Insufficient Evidence to Determine Whether an Association
Exists
Any cancer
Cardiovascular conditions or conditions of the blood and
blood-forming organs
Endocrine, nutritional, and metabolic conditions
Neurodegenerative diseases other than ALS
Neurocognitive and neurobehavioral performance
Migraines and other headache disorders
Other neurologic conditions
Respiratory conditions
Structural gastrointestinal conditions
Skin conditions
Musculoskeletal system conditions
Genitourinary conditions
Specific birth defects
Adverse pregnancy outcomes (e.g., miscarriage, stillbirth,
preterm birth, and low birth weight)
Fertility problems
Increased mortality from any cancer, any neurologic disease
(including multiple sclerosis, Alzheimer's disease, Parkinson's
disease, and ALS), respiratory disease, or gastrointestinal disease
Limited/Suggestive Evidence of No Association
Objective measures of peripheral neurologic conditions
Multiple sclerosis
Mortality from cardiovascular, infectious, or parasitic
diseases
Decreased lung function
Mortality due to mechanical trauma or other external causes
As requested in its statement of task, the committee had additional
discussions pertaining to Gulf War illness, neurologic conditions, and
lung and brain cancer on those health conditions and other aspects of
Gulf War veteran health.
Gulf War Illness. Gulf War illness is the signature adverse health
outcome of having served in the Persian Gulf region. Multiple studies
found that some Gulf War veterans, regardless of their country of
origin and their different deployment-related exposures, have
persistent, debilitating, and varying symptoms (such as joint and
muscle pain, fatigue, and cognitive problems) of Gulf War illness. In
spite of over 2 decades of research to define, diagnose, and treat Gulf
War illness, little progress has been made in elucidating the
pathophysiologic mechanisms that underlie it, the exposures that may
have caused it, or treatments that are generally effective for it.
Gulf War illness is not an easily defined or diagnosed condition.
The committee concluded that it is not a psychosomatic illness, but it
does present with diverse symptoms, many of which overlap with other
health conditions such as chronic fatigue syndrome, neurodegenerative
disorders, and musculoskeletal problems. Based on available research
data, it does not appear that a single mechanism can explain the
multitude of symptoms seen in Gulf War illness, and the committee found
it unlikely that a single definitive causal agent would be identified
this many years after the war. Furthermore, most Gulf War illness
studies have excluded the psychological aspects of the condition with
regard to both diagnosis and treatment although veterans report
symptoms such as chronic pain and sleep disturbances that may be
amenable to psychological therapies, alone or in conjunction with other
treatments.
The committee concluded that although the existence of an animal
model would be advantageous for identifying and evaluating treatment
strategies for Gulf War illness, it cautions that developing such an
animal model is precluded by the absence of any objective measures of
chemical and nonchemical exposures during Gulf War service, let alone
the frequency, duration, or dose of those exposures, or the highly
likely interactive effects of multiple exposures.
Neurologic Conditions. The committee found little new information
pertaining to multiple sclerosis, Parkinson's disease, Alzheimer's
disease, or migraines. ALS is the only neurologic disease for which the
committee found limited/suggestive evidence for an association with
deployment to the Gulf War. The committee concluded that further
follow-up of this uniformly fatal disease is warranted. The Gulf War
veteran population is still young with respect to the development of
other neurodegenerative diseases; therefore, the effects of deployment
on their incidence and prevalence may not yet be obvious.
Lung Cancer and Brain Cancer. The committee found the evidence for
brain cancer to be inadequate/insufficient and it found no
statistically significant increase in the current risk of brain cancer
in deployed Gulf War veterans compared with their nondeployed
counterparts. This finding is mirrored in another recent IOM study.
With regard to lung cancer, the committee notes that the 10-15 years of
follow-up that have been reported may not have been adequate to account
for the long latency of this disease. Although one new study found an
increased incidence of lung cancer for deployed versus nondeployed
veterans, neither veteran group had a greater risk when compared with
the general population, and the study did not indicate smoking status.
Thus, the committee found that the evidence continues to be inadequate/
insufficient to determine whether deployed Gulf War veterans are at
increased risk of having any cancer, including lung and brain cancer.
The relative rarity of cancers such as brain cancer argues for larger
studies with adequate power to detect them.
Other Health Outcomes. The committee finds that sufficient time has
elapsed to determine that Gulf War deployed veterans do not have an
increased incidence of circulatory, hematologic, respiratory,
musculoskeletal, structural gastrointestinal, genitourinary,
reproductive, or chronic skin conditions compared with their
nondeployed counterparts. As Gulf War veterans age, it will be more
difficult to differentiate the effects of deployment from the natural
effects of aging on morbidity and mortality. Furthermore, the
association of deployment to the Gulf War with PTSD, anxiety disorders,
substance abuse, and depression is well established, and further
studies to assess whether there is an association are not warranted.
Although there are well-known differences in disease profiles
according to sex and race/ethnicity, few studies on Gulf War veterans
specifically report outcomes for women or minorities, although many
veteran studies adjust for sex and race/ethnicity in their analyses.
This lack of distinction is important and makes it imperative that
researchers report sex-specific and race/ethnicity-specific outcomes,
particularly in large cohorts and where population subgroups may be
oversampled.
In conclusion, what is striking about this and prior Gulf War and
Health committees' findings is that the health conditions found to be
associated with Gulf War deployment are primarily functional medical
disorders such as Gulf War illness and irritable bowel syndrome, and
mental health disorders such as PTSD and depression. What links these
conditions is that they have no objective medical diagnostic tests and
are diagnosed based on subjective symptom reporting.
To be clear, the committee recognizes that Gulf War illness is a
distinct medical condition with symptoms that affect many organs and
organ systems including the brain; these symptoms include cognitive
difficulties, memory problems, and headaches. Many other chronic
illnesses from kidney disease to cancer also can affect the brain.
Based on its conclusions regarding the association between
deployment to the Gulf War and the health conditions seen in Gulf War
veterans 25 years after the war, the committee made the following
recommendations:
Recognize the connections and complex relationships
between brain and physical functioning and should not exclude any
aspect of Gulf War illness with respect to improving its diagnosis and
treatment.
The Department of Veterans Affairs and the Department of
Defense should develop a joint and cohesive strategy on incorporating
emerging diagnostic technologies and personalized approaches to medical
care into sufficiently powered future research to inform studies of
Gulf War illness and related health conditions.
The Department of Veterans Affairs should continue to
conduct follow-up assessments of Gulf War veterans for
neurodegenerative diseases that have long latencies and are associated
with aging; these include amyotrophic lateral sclerosis, Alzheimer's
disease, and Parkinson's disease.
The Department of Veterans Affairs should conduct further
assessments of cancer incidence, prevalence, and mortality because of
the long latency of some cancers. Such studies should maximize the use
of cancer registries and other relevant sources, data, and approaches,
and should have sufficient sample sizes to account for relatively rare
cancers and to be able to report sex-specific and race/ethnicity-
specific information.
Further studies to assess the incidence and prevalence of
circulatory, hematologic, respiratory, musculoskeletal, structural
gastrointestinal, genitourinary, reproductive, endocrine and metabolic,
chronic skin, and mental health conditions due to deployment in the
Gulf War should not be undertaken. Rather, future research related to
these conditions should focus on ensuring that Gulf War veterans with
them receive timely and effective treatment.
Without definitive and verifiable individual veteran
exposure information, further studies to determine cause-and-effect
relationships between Gulf War chemical exposures and health conditions
in Gulf War veterans should not be undertaken.
Sex-specific and race/ethnicity-specific health
conditions should be determined and reported in future studies of Gulf
War veterans. In addition, selected prior studies (e.g., large cohort
studies) should be reviewed to determine whether reanalysis of the data
to assess for possible sex-specific and race/ethnic-specific health
conditions is feasible.
Future Gulf War research should place top priority on the
identification and development of effective therapeutic interventions
and management strategies for Gulf War illness. The Department of
Veterans Affairs should support research to determine how such
treatments can be widely disseminated and implemented in all health
care settings.
The committee believes that it is time that research efforts move
forward and focus on improving treatment and medical management of
veterans for Gulf War illness, including all affected organs and
systems of the body. Further exploration of treatments and management
strategies for the symptoms of Gulf War illness, even in the absence of
a definitive etiology, is warranted.
Finally, the committee wants to emphasize that it did not recommend
that research on the health of Gulf War veterans be stopped. Rather,
the committee found that research that continues to seek a causal link
between Gulf War illness or other health conditions found in Gulf War
veterans and specific chemical exposures, such as PB, sarin, or
pesticides, is not likely to yield useful information. Many millions of
dollars have been spent on this research with few tangible results and
those resources are more likely to have an impact if focused on
treatment and management strategies for these veterans.
Thank you and I am pleased to answer any questions that you may
have.
Prepared Statement of Roberta F. White, Ph.D
Gulf War illness and the health of Gulf War veterans: 25 years of
progress and set-backs
It is the 25th anniversary of the Gulf War. Our veterans won this
conflict in less than a week. However, concern remains high that the
troops who produced this victory are and will remain ill, without
legitimate acknowledgement of their health problems and the associated
disabilities, and without effective treatment options now or in the
future.
Despite decades of scientific evidence to the contrary, the VA and
the Institute of Medicine have recently produced documents that
minimize the poor health of these veterans by terming their illnesses
as ``functional `` disorders, a medical term for psychiatric illness.
This injustice is then compounded by a treatment guideline that
suggests ineffective, unproven, purely palliative, and potentially
harmful treatments for Gulf War illness that focus on psychiatric
symptomatology.
I speak as a clinician/scientist who has worked with Gulf War
veterans clinically and in research for over 20 years. My work on Gulf
War illness is part of an overall clinical and research career in which
I have studied the effects of exposures to neurotoxic chemicals on
adults and children. For eight years, until last fall, I served as
scientific director of the Research Advisory Committee on Gulf War
Veterans Illnesses.
Science of Gulf War illness
It has been known since a year or two after their return from the
Gulf that a subset of Gulf War veterans was experiencing debilitating
physical illness. (In fact, the Department of Public Health at VA
engaged clinical and research personnel at the Boston VA Medical
Center, including myself, in trying to figure out what was going on
with the veterans).
Research beginning at that time and continuing to the present has
produced a consensus of scientific knowledge about this illness.
- Dozens of studies in multiple countries reveal that
approximately 30% of the 1991 Gulf War veteran population suffers from
a characteristic pattern of physical health symptoms. This research has
further revealed that this pattern of health problems was seen in Gulf
War veterans, but not veterans of other conflicts (such as Bosnia), and
that veteran populations from multiple coalition forces from the Gulf
War experienced the same disorder.
The health problems of Gulf War veterans are not vague and
extremely variable, as is often suggested. There are two case
definitions of the illness-the Kansas definition and the Centers for
Disease Control definition-that clearly allow researchers and
clinicians to decide whether an individual Gulf War veteran has the
illness. These definitions were supported by the Institute of Medicine
in its Volume 9 report for use in clinical and research work. I cannot
think of any illness in which all patients have exactly the same
symptoms-diagnosis of diseases and disorders is based on critical
masses of signs and symptoms that cluster together to fit a case
definition. Gulf War illness is not different from any other disorder
in this way.
- This illness is not the result of stress or other psychiatric
factors. It has been known since the 1990s that post-traumatic stress
disorder occurs at far lower rates in Gulf War populations than Gulf
War illness. Rates are typically less than 10%, in contrast to the 30%
for Gulf War illness. Furthermore, research conducted in veterans with
Gulf War illness has repeatedly shown that post-traumatic stress
disorder and other psychiatric disorders do not predict whether a
veteran will have Gulf War illness, that is rates of Gulf War illness
are not significantly higher in Gulf War veterans with psychiatric
diagnoses.
- Research over the past 20 years has also shown that occurrence
of Gulf War illness is associated with exposures to chemicals present
in the Gulf War theater, especially pesticides and use of
pyridostigmine bromide (and possibly other chemicals, including nerve
gas agent sarin and particulate matter from oil well fires).
Epidemiologic, clinical, and animal research involving Gulf War
veterans and other populations with similar types of exposures has
converged to show that these chemicals affect the central nervous and
immune systems, producing chronic signs and symptoms that affect
multiple body systems.
As suggested by the Institute of Medicine in its recent Volume 10
report, there is a mind/body continuum here. However, it is not that
these veterans have a psychiatric condition that is affecting their
physical health; it is that exposures to the chemicals present in the
Gulf theater affect brain systems that mediate cognition, emotion, and
immune function simultaneously. Thus, ill veterans have multiple
cognitive, physical and emotional complaints and signs and symptoms.
The previous Institute of Medicine report, Volume 8, reflected the
scientific consensus on Gulf War illness that I have just described,
concluding that ``[t]he excess of unexplained medical symptoms reported
by deployed Gulf war veterans cannot be reliably ascribed to any known
psychiatric disorder'' and that ``it is likely that Gulf War illness
results from an interplay of genetic and environmental factors.''
Like the reports of the Research Advisory Committee, the Volume 8
Institute of Medicine report called for rigorous research to find
effective treatments for the illness, including ``studies to identify .
. . modifications of DNA structure related to environmental exposures,
. . . signatures of immune activation, or brain changes identified by
sensitive imaging measures.''
Effective treatments for Gulf War illness and other illnesses
induced by exposures that damage the brain do not exist. This is true
for exposures such as lead, mercury and solvents as well as the
pesticides, pyridostigmine bromide, low-level chemical warfare agents,
and air pollutants to which our Gulf War veterans were exposed.
However, recent research has identified potential treatments of Gulf
War illness that target specific nervous system and immunological
mechanisms. These treatments are now being piloted. They are consistent
with the types of treatments recommended in the Volume 8 Institute of
Medicine report and hold promise for effective treatment of Gulf War
veterans, other veterans who experience chemical exposures, future
troops at risk of similar exposures, and people who are exposed to
pesticides occupationally and environmentally.
The progress made over the past 20 years in understanding the
mechanisms and causes of Gulf War illness, the physiological effects of
exposure to chemicals such as pesticides, and the treatment of these
effects is extremely exciting for the health of the military and the
population as a whole. The scientific findings from this research hold
great scientific promise. In addition, they are the only source of hope
for veterans with Gulf War illness who are suffering from the disorder
and wish to lead healthier, more productive lives.
VA treatment recommendations
However, recent recommendations from VA concerning the diagnosis
and treatment of ill Gulf War veterans threaten the viability of the
promise emanating from two decades of research. These recommendations
are summarized in a document entitled, VA/DoD Clinical Practice
Guideline: Management of Chronic Multi-symptom Illness, 2014.
The recommendations contained in this document are regressive in
terms of the knowledge that science and medicine have provided on the
disorder. They are consistent with the stance that VA has taken since
the Gulf War illness issue was first discovered in the early 1990s,
when VA staff published papers saying that the health problems of Gulf
War veterans represented post-traumatic stress disorder or ``effects
seen in all wars,'' statements that were made before any scientific
data had been collected on ill Gulf War veterans.
The treatment recommendations include immediate referral for mental
health evaluation. In addition, cognitive behavioral therapy is
suggested. This is a palliative treatment that might allow veterans to
manage their lives better but was already found in a major VA study to
help less than 6% of GW veteran patients and to provide only a 1 point
improvement on a scale of 100.
Even worse, when these palliative therapies do not satisfy the
patient, the treatment guidelines recommend eleven drugs, ten of them
psychiatric. All eleven drugs are noted in the guidelines to have
significant adverse side effects, including suicidal ideation. Even
more disturbing, these medications have not been studied with regard to
effectiveness in the treatment of Gulf War illness. They are not the
medications or treatment approaches of choice among the VA clinicians
with extensive clinical treatment experience who have discussed their
approaches with the Research Advisory Committee on Gulf War Veterans
Illnesses. And the advice of such experts does not seem to have been
solicited for this treatment document.
In my experience as a neuropsychologist, I have had many patients
whose neurological illnesses were initially thought to be psychiatric-
the term ``functional'' was, in fact, sometimes used to describe them.
These patients include people with multiple sclerosis, small vessel
strokes, dementias and exposures to chemicals such as solvents or
mercury. Treating Gulf War illness with an antidepressant is akin to
treating multiple sclerosis with one. The patient might feel a little
more optimistic, but the medication will do nothing to reverse or
prevent the brain damage that the multiple sclerosis disease process is
inflicting on his or her brain.
Furthermore, the VA treatment document says its advice is also
appropriate for mild traumatic brain injury, suggesting that recent
Iraq and Afghanistan veterans who suffered blast injuries from
improvised explosive device (IED) exposures should also be treated as
psychiatric cases.
IOM report Volume 10
The recent Volume 10 Institute of Medicine report further
contributes to the worsening plights of ill Gulf War veterans by
minimizing their health problems and again placing a psychiatric cast
on them.
This report was written by a committee that (purposefully) included
no one with clinical experience treating Gulf War veterans or in-depth
epidemiological expertise in the phenomenology of Gulf War illness.
The report supports the VA stance that Gulf War illness is a
functional disorder without evaluating the extensive scientific
evidence that demonstrates just the opposite.
Although the Volume 10 Institute of Medicine report states that the
science has not changed since the Volume 8 report, its conclusions fly
in the face of the scientific consensus on Gulf War illness that I have
described, a consensus that was embraced in the Volume 8 report. The
Volume 10 report distorts and disavows the Volume 8 report's finding
that Gulf War illness ``cannot be reliably ascribed to any known
psychiatric disorder'' by saying that the illness ``cannot be fully
explained by any .psychiatric disorder.''
Unlike prior reports that support mechanistic scientific research
on Gulf War illness, Volume 10 suggests that ``it is time research
efforts focus on the [mind-body] interconnectedness'' and that
``further research to determine the relationships between Gulf War
exposures and health conditions in Gulf War veterans should not be
undertaken.''
To recommend stopping research into the mechanisms underlying the
disease, just as research into these mechanisms has begun to make real
progress, is shockingly short-sighted. And to suggest that psychiatric
research has been neglected could not be further from the truth.
During the fifteen years after the war, federal Gulf War research
focused mainly on psychiatric issues. For example, 51% of VA research
funding in 2003 for Gulf War illness focused on psychological stress
and psychiatric illness. This research revealed that the answer to the
Gulf War illness problem could not be found in the psychiatric arena.
It is unthinkable that the scientific progress now being made should be
halted and to return to that era.
Conclusion
When I think of the problem of Gulf War illness and the health
problems and disabilities of the many Gulf War veterans whom I know or
have evaluated, I am painfully reminded of the veterans of World War I
who were exposed to mustard gas in the trenches of Europe. The gas was
known to be present and widespread and it was known that mustard was
designed to make people very sick or kill them. However, these veterans
did not receive support for their health problems or the hardships
their families endured due to their disabilities when they returned
from combat.
We are experiencing the same phenomenon with the 1991 Gulf War. It
is well known and established that Gulf War veterans were exposed to
poisons such as pesticides, pyridostigmine bromide, sarin gas and air
pollutants from oil well fires that are harmful to health. However,
groups like the Institute of Medicine and VA state that with current
technology we cannot identify exactly which chemicals and which dosages
each individual veteran was exposed to. This leads them to claim that
we do not know enough to conclude that the Gulf War veteran population
was over-exposed to toxic chemicals and that individual veterans are
ill. This is not the approach to population environmental health
problems that we should expect.
Prepared Statement of Anthony Hardie
Thank you, Chairman Coffman, Ranking Member Kuster, and Members of
the Committee for today's hearing and for this opportunity to appear
before you.
I'm Anthony Hardie, a 1991 Gulf War and Somalia veteran, and
Director of Veterans for Common Sense. I've provided testimony on
several previous occasions, but today is especially notable.
Twenty-five years ago tonight, we launched the ground war of
Operation Desert Storm and successfully liberated Kuwait. Tonight, I
would like us to remember and honor of the nearly 300 of our fellow
Gulf War men and women who made the ultimate sacrifice. I would also
like us to remember and honor the nearly 700,000 veterans of the
Persian Gulf War, who under the direction of our military leaders led
our broad international Coalition to decisive military victory.
``Our'' war was relatively short: just a five-month buildup, and
then a six-week war before a swift military victory. However, you've
heard my personal experiences before, and you've heard the stories of
many other Gulf War veterans, and as this Committee knows, between one-
fourth and one-third of us returned home with serious and debilitating
health issues now known as Gulf War Illness. And, we faced a new
battle, a much longer war - a war to obtain effective healthcare and VA
assistance from entrenched government officials who seemed intent on
proving there was nothing wrong with so many Gulf War veterans, that it
was all in our heads, just stress, the same as after every war.
1998 PERSIAN GULF WAR VETERANS LEGISLATION
It took almost eight years after the war before our major
legislative victory, with the enactment of the Persian Gulf War
Veterans Act of 1998 (Title XVI, PL 105-277) and the Veterans Programs
Enhancement Act of 1998 (PL 105-368, Title I-``Provisions Relating to
Veterans of Persian Gulf War and Future Conflicts'') - two landmark
bills that set the framework for Gulf War veterans' healthcare,
research, and disability benefits.
For those of us involved in fighting for the creation and enactment
of these laws, they seemed clear and straightforward, with a
comprehensive, statutorily-mandated plan that would guarantee research,
treatments, appropriate benefits, and help ensure that lessons learned
from our experiences would result in never again allowing what happened
to us to happen to future generations of warriors.
The legislation included a long list of known Gulf War exposures.
VA was to presume our exposure to all of these, and then, with the
assistance of the National Academy of Sciences (NAS), evaluate each
exposure for associated adverse health outcomes in humans and animals.
In turn, the VA Secretary would consider the reports by the NAS's
Institute of Medicine (IOM), ``and all other sound medical and
scientific information and analyses available,'' and make
determinations granting presumptive conditions. There was a new
guarantee of VA health care. There would also be a new national center
for the study of war-related illnesses and post-deployment health
issues, which would conduct and promote research regarding their
etiologies, diagnosis, treatment, and prevention and promote the
development of appropriate health policies, including monitoring,
medical recordkeeping, risk communication, and use of new technologies.
There was to be an effective methodology for treatment development and
evaluation, a medical education curriculum, and outreach to Gulf War
veterans. Research findings were to be thoroughly publicized. To ensure
the federal government's proposed research studies, plans, and
strategies stayed focused and on track, VA was to appoint a research
advisory committee that included Gulf War veterans - presumably those
who were ill and affected - and their representatives.
Instead, we learned that enactment of those laws was just another
battle in our long war.
From the beginning, VA officials fought against implementing these
laws, dragging their feet and upending their implementation.
The creation of the ``national center'' never met Gulf War
veterans' expectations. The long list of toxic exposures never led to a
single exposure-related presumption. Many of the exposures were never
even considered, and those that were didn't include evaluation of the
health effects in laboratory animals with respect to likely health
outcomes in ill Gulf War veterans. The research never led to effective,
evidence-based treatments and indeed had little treatment focus until
after Congress established a treatment-focused research program outside
of VA.
And only after significant pressure and a change in Administrations
did VA finally establish the research advisory committee (RAC) - more
than three years after the statutorily mandated January 1, 1999
deadline. But, VA then systematically ignored its recommendations, and
diminished its findings. When it sharpened its criticism of VA's
failures related to Gulf War veterans, VA staff led measures to
substantially diminish its charter and discharge all of its members.
As a last ditch effort to call attention to VA's myriad failures of
Gulf War veterans, I led Gulf War veterans' resignations from the RAC
in June 2013. Subsequently, the House unanimously passed legislation
that would have restored and enhanced the research advisory committee
and helped Gulf War veterans, for which we remain grateful.
Unfortunately, the Senate failed to take action and the bill died in
Congress.
I served on the RAC for eight years and remain deeply impressed by
the broad knowledge, demonstrated commitment, and impressive
accomplishments aimed at solving Gulf War Illness of the scientists and
doctors who served on and appeared before the panel. And, I remain
proud of the work of dozens of researchers and Gulf War veteran
stakeholders who came together to produce a comprehensive strategic
plan aimed at solving Gulf War Illness, identifying other health
conditions in Gulf War veterans, and helping achieve the laudable goals
of the 1998 Gulf War legislation. Sadly for ill Gulf War veterans,
nearly all of the provisions of that research strategic plan remain
unimplemented, like so much of the rest of VA's half steps in
implementing and achieving the goals of the 1998 legislation.
And in a 2013 hearing by this Committee, we learned from a top VA
epidemiologist-turned-whistleblower many of the sordid details of
officials within the VA's Office of Public Health who failed to ask the
right questions in research that would lead to showing the real post-
deployment health outcomes for Gulf War and other veterans, and often
obfuscated research findings when they showed results that might show
significant health outcomes.
That leads us to today.
NEW IOM REPORT
Two weeks ago, the NAS's Institute of Medicine (IOM) released its
newest and supposedly final report in the extended, ``Gulf War and
Health,'' series under VA contract as directed by the 1998 legislation.
Entitled, ``Gulf War and Health, Volume 10: Update of Health Effects of
Serving in the Gulf War, 2016,'' it is highly problematic. While IOM's
Volume 10 acknowledged that Gulf War illness is the signature adverse
health outcome of the 1991 Gulf War - a fact that has been known by
Gulf War veterans since the early 1990s and definitively shown by
science since at least 2004 - its research and treatment
recommendations range from disappointing to potentially damaging to the
health and lives of Gulf War veterans with Gulf War Illness.
IOM's Volume 10 recommends no further research using animal models
of Gulf War toxic exposures (p. 251). While the IOM Volume 10 panel
acknowledged that an animal model would be advantageous for identifying
and evaluating Gulf War Illness treatment strategies, they then
suggested that the precise frequency, duration, dose of Gulf War
exposures must be known in order to do so. This amounts to ``rolling up
the sidewalk'' on this promising avenue of Gulf War Illness research,
just when it is beginning to unravel the underlying biological
mechanisms of Gulf War illness and point to treatment targets.
Past IOM review panels have been limited by VA's systemic failures
in monitoring, assessing, and reporting the incidence and prevalence of
health symptoms and diagnosed diseases in Gulf War (and other cohorts
of) veterans. The IOM Volume 10 panel was similarly limited. As one
example, IOM's Volume 10 report reads, ``Because cancer incidence in
the last 10 years has not been reported [by VA], additional follow-up
is needed.'' (p.102). IOM's Volume 10 panel was tasked with reviewing
published medical literature since the last major review six years ago,
but due to one of VA's many failures couldn't do so because this new
data hasn't been reported by VA.
However, unlike the panel's recommendation for additional follow-up
with cancer incidence, IOM's Volume 10 committee instead inflicted
damage when they recommended that, ``further studies to assess the
increased incidence and prevalence of circulatory, hematologic,
musculoskeletal, gastrointestinal, genitourinary, reproductive,
endocrine and metabolic, respiratory, chronic skin, and mental health
conditions due to deployment in the Gulf War should not be undertaken''
(pp. 9-10). Unlike IOM panels that are limited by VA's ``don't look,
don't find'' failures, we must not mistake absence of VA evidence for
evidence of absence of long histories of these adverse health outcomes
in Gulf War veterans.
Like the earlier IOM reports, the Volume 10 panel found no new
associations between Gulf War exposures and adverse health outcomes. It
also found no new associations between Gulf War service and ill health.
While recommending greater effort towards treatment and
acknowledging Gulf War Illness as the signature condition of the 1991
Gulf War, it recommended that research and treatment for Gulf War
Illness now focus on, ``brain-body interconnectedness.'' It also
suggests focusing on ``management'' of Gulf War Illness. Together,
these are an apparent departure from the optimism of the 2010 IOM
report, which said, ``effective treatments, cures, and, it is hoped,
preventions . can likely be found.''
The promising new science that is providing keys to Gulf War
Illness's underlying mechanism and promising avenues towards treatment
hasn't shifted course since 2010, it has just provided even greater
evidence for the role of toxic exposures in Gulf War Illness and
provided increasing detail in closing in on effective treatments. What
has changed, however is that the IOM Volume 10 panel and reviewers
included some of the same people and the same mindsets as the dark days
of the 1990's, when everything about Gulf War veterans' exposures and
symptoms was characterized as utterly unknowable, when Gulf War
veterans' health issues were marginalized, and when VA and DOD
officials seemed intent on restricting Gulf War Illness discussions to
``stress'' causation and mental health management rather than focusing
on evidence-based treatments for Gulf War veterans' toxic wounds. Those
VA and DOD officials denied Gulf War veterans' toxic exposures, failed
to develop treatments or preventions, redirected Gulf War veterans away
from the goal of real healthcare, shut down research, and denied
benefits. This new IOM recommendation amounts to little more than the
same tired old themes from the 1990's - again, just when Gulf War
Illness treatment research is finally making real progress to
understand the illness and identify treatments
As I walked through the airport headed home following the meeting
where this latest IOM report was released, my shoulder was heavy with a
bag full of past IOM Gulf War reports. My heart was even heavier.
Twenty-five years after our war, and nearly two decades after the
enactment of the 1998 laws, these IOM Gulf War reports nearly fill a
small shelf. But despite millions of dollars and countless panel
members' work, the collective weight of these volumes have not
associated animal exposures with human health outcomes, have found
precious few health outcomes associated with Gulf War service, have not
evaluated many of the exposures listed in the 1998 laws, and have added
little toward the development of effective, evidence-based treatments
for Gulf War Illness. Together, the IOM and its VA taskmaster have had
little impact in improving the health or lives of Gulf War veterans
with Gulf War Illness or achieving the goals set forth in the 1998 Gulf
War legislation.
VA/DOD CLINICAL PRACTICE GUIDELINE (CPG)
As if the massive, multi-volume failure of Gulf War veterans wasn't
enough, VA and DoD have now developed a highly problematic Clinical
Practice Guideline for Gulf War Illness that goes back to the darkest
days of the 1990s. In this Guideline, VA and DOD lump Gulf War Illness
together with psychosomatic and other conditions that together, its
authors call, ``Chronic Multisymptom Illness'' (CMI). It is worth
noting that CMI is an overly broad and inappropriate catch-all label
that IOM panels have rightly told VA to stop using for Gulf War
Illness.
This Clinical Practice Guideline is intended for all healthcare
providers - DOD, VA, and beyond. Its primary treatment recommendations
for GWI are cognitive behavioral therapy (CBT), exercise, and
psychotropic drugs. Suicidal ideation is listed in the Guide as a known
``notable adverse effect'' for every single one of those medications.
Despite public statements by VA officials, including before this
Committee, that Gulf War Illness is not a psychological, psychiatric,
or psychosomatic condition, this VA-DoD guide specifically compares
``CMI'' with a group of, ``similar `overlapping' symptom syndromes''
and ``somatization disorder''. The terms ``somatization disorder'', and
use the terms ``somatization'', ``somatization disorder'',
``somatoform'', and ``somatoform disorder'', and ``psychosomatic'' a
stunning 52 times in the guide. The term, ``hypochondriasis'' is also
used and referenced.
While the Clinical Practice Guideline authors use the term,
``evidence-based'', 19 times throughout the document in an apparent
attempt to increase its credibility, they go on to state, ``treatment
of CMI is as much an art as it is a science'' (p.8).
Showing its failure to rely on scientific evidence, a growing body
of promising scientific research related to inflammatory cytokines,
mitochondria and mitochondrial dysfunction (for example), including
Coenzyme Q10 as a potential therapy. Yet, the term ``cytokine'' and
variants appear only twice, and no reference whatsoever is made to
mitochondria or word variants.
It would seem hard to believe, given the large body of peer-
reviewed science on Gulf War Illness that has been published in more
recent years, that a DOD or VA clinical guideline produced in 2014
would rely on the old ``psychosomatic'' fictions of the 1990s or on the
VA and DOD officials that championed them. What's not surprising,
however, is that the list of people who developed this guide that
relies on psychosomatic artfulness rather than evidence-based
treatments included some of the same old names from the dark days of
the 1990s.
This guide is another example of VA's systemic research failures.
From, ``Don't look, don't find,'' to a renewed reliance on
psychosomatic explanations and ``treatments'' for Gulf War Illness, the
intent of the 1998 laws remain out of reach at VA past and present.
GULF WAR ILLNESS CDMRP
As many of the members of this Committee know, despite the serious
problems noted above, there is a great deal of encouragement and hope
for ill Gulf War veterans in the science being conducted and published
in recent years. Much of this promising new research is in the
treatment-focused Gulf War Illness Congressionally Directed Medical
Research Program (CDMRP), which exists outside VA or the rest of DoD
thanks to Congress, including many of the Members on this Committee.
One-third of the studies funded through this program are testing
treatments that might help improve the health and lives of veterans
with GWI. Two-thirds of the studies are aimed at Gulf War Illness's
underlying mechanisms, including critically important animal studies
that test exposures and measure health outcomes, identify treatment
targets, and test treatments.
Three CDMRP-funded treatment studies have already shown promise in
reducing certain GWI symptoms, including Coenzyme Q10, Carnosine, and
acupuncture. Others have found powerful links between Gulf War toxic
exposures and adverse health outcomes and are helping pave the way for
treatment development.
The vast majority of this research is still in the pipeline.
However, this powerfully encouraging progress could be at risk, by the
IOM Volume 10 recommendations and by another IOM panel aimed at all the
CDMRPs that is chaired and directed by some of the same former VA and
DOD officials of the 1990s who have done so much harm to Gulf War
veterans.
CONCLUSIONS
If we measure VA's success by how it has improved Gulf War
veterans' health twenty-five years after the war, VA still has no
evidence-based treatments for Gulf War Illness. VA has circumvented or
ignored most of the aims of the 1998 laws. Instead, some of those same
old VA and DOD officials from the dark days of the 1990s have joined
together in their usual old cabal and are once again pushing long-
discredited theories of psychosomatic causation and ``treatment'' in
new and potentially influential ways.
In twenty-five years, VA has made little progress on Gulf War
Illness, and now appears to be working to roll back the clock to the
dark days of the 1990's.
u Instead of following recommendations on Gulf War Illness research
that would lead to improving ill Gulf War veterans' health and lives,
VA eliminated the Research Advisory Committee's (RAC) ability to
evaluate the effectiveness of all federal Gulf War research efforts,
limited its scope from all federal research to just VA's, eliminated
its treatment focus mandate, and more.
u VA admitted to ``losing'' its registry for Gulf War spouses and
children. It is unclear what VA has done to recover that data.
u VA continues make reports to Congress that inflate ``Gulf War
research'' spending by including studies that are not specific to Gulf
War veterans.
u VA has the authority to develop new presumptives for these ill
and suffering veterans, but unlike with Agent Orange, has failed to
identify any new conditions beyond a set of rare endemic infectious
diseases that affect almost no one.
u IOM's latest report, shaped by VA's contract, argues that
individual Gulf War exposures are forever unknowable. We knew that when
seeking the 1998 legislation, aimed at connecting generic exposure data
with health outcomes. VA has stymied those efforts.
u VA has not linked a single adverse health outcome to any Gulf War
exposures nor created a single new presumptive condition under the 1998
laws to help suffering veterans beyond the largely irrelevant endemic
infections noted earlier.
Twenty-five years later, one-fourth to one-third of us Gulf War
veterans continue to struggle with the health and life effects of Gulf
War Illness. Others among us have died of ALS, brain cancer, other
diseases, suicide. Yet VA, with the aid of DoD and the complicity of
the IOM, has made little progress in developing evidence-based
treatments or improving the health and lives of veterans suffering from
signature injury of the 1991 Gulf War - Gulf War Illness.
Twenty-five years later, one-fourth to one-third of us continues to
battle the signature injury of the 1991 Gulf War: Gulf War Illness.
Others among us have died of ALS, brain cancer, other diseases,
suicide. Yet VA, with the aid of DoD and the complicity of the IOM, has
made little progress in developing evidence-based treatments or
improving the health and lives of veterans suffering from signature
injury of the 1991 Gulf War - Gulf War Illness.
Twenty-five years later, ill Gulf War veterans are still in pain.
They are suffering. They have been begging for help for years and
years. Twenty-five years later, Gulf War veterans are battling against
VA and DOD bureaucrats, including some of the very same ones who fought
against the 1998 laws in the first place.
We must not continue to allow VA and DoD to substitute ``risk
communication'' for evidence-based healthcare, psychosomatic drugs for
treatment-focused research, spin for substance, or ``Don't look, don't
find'' for the objective collection, analysis, and reporting of
deployment health outcomes. The letter, the spirit, and the intent of
the 1998 Persian Gulf War laws have yet to be achieved.
On this 25th anniversary of the war, our Gulf War veterans deserve
the best that modern science and the U.S. government can offer to
improve their health and lives. Mr. Chairman, as one of us Gulf War
veteran, and Members of this powerful Committee, please join together
with your colleagues on both sides of the aisle and in both houses and
help fix these serious issues, once and for all.
Statements For The Record
LUNG CANCER ALLIANCE
Lung Cancer Alliance (LCA) thanks the chairman and the committee
for allowing the submission of the following comments for the record of
this hearing.
LCA, the leading national lung cancer policy, advocacy and patient
support organization, is deeply concerned by the lack of updated
disease specific incidence and mortality data from the Department of
Veterans Affairs in the Gulf War and Health Volume 10 Report.
Without this critical information, the Vol. 10 report, perforce,
had to conclude:
``...that there is insufficient/adequate evidence to determine
whether an association exists between deployment to the Gulf War and
any form of cancer, including lung cancer and brain cancer.''
The Vol.8 report indicated that at that point in time, only lung
cancer showed a statistically relevant excess between Gulf War deployed
veterans and non-deployed veterans, based on a published 2010 study by
Young et al which linked Defense Manpower Data Center datasets with
files from 28 state cancer registries and the Department of Veterans
Affairs Central Cancer Registry.
The study concluded that the 15% excess of lung cancer diagnoses in
deployed veterans over the years 1991-2006 warranted additional follow-
up studies. Indeed, the Vol.10 report concluded that additional follow-
up was necessary.
The Vol.10 report gives no indication that this was done. In fact,
on page 102, the Vol. 10 Report states:
Because cancer incidence in the past 10 years has not been
reported, additional follow-up is needed.
Many cancers have long latency periods, 20-30 years in the case of
lung cancer as both Vol. 8 and 10 accurately report. The median age for
a cancer diagnosis in the United States is 65 (70 for lung cancer) and
the median age of Gulf War veterans in 1991 was 28. Thus, the impact of
Gulf War deployment on cancer incidence and mortality cannot be
accurately evaluated without long term follow-up and accurate incidence
and mortality statistics.
Updating the 2010 Young study would have been the most logical,
cost-effective and statistically significant resource in preparing for
Vol.10.
The only other Primary study cited in Vol.10 was the 2015 update
(Sim et al.) on the Australian Gulf War veterans which did not show
elevated cancer incidence or mortality rates. However, while the survey
included all 1,871 Australia Gulf war veterans, 84% were Navy, not
deployed ground forces, and 87% were under the age of 55 at the time of
the update.
The Vol. 10 report conceded that telephone/web surveys of U.S. Gulf
War veterans by committee member (Dursa et al., 2015) and the VA
showing no disparity of impact did not qualify as primary studies and
were not sufficiently powered or cross-checked with actual mortality
and incidence data to be considered statistically significant.
When queried by LCA, the committee staff indicated that they did
not ask the VA for disease-specific mortality data. Clearly this has to
be done.
Lung cancer is the leading cause of all cancer deaths. Its annual
mortality is equivalent to all deaths from breast, prostate, colon and
pancreatic cancers combined. Veterans, especially those who served in
combat, are at highest risk due to the combination of smoking rates and
exposure to carcinogens.
CT screening for a defined high risk population ages 55-80 has been
validated by one of the largest randomized controlled trials ever
carried out by the National Cancer Institute, given a B recommendation
by the U.S. Preventive Services Task Force, a required preventive
service covered by commercial insurance and Medicare with no co-pays,
deductibles or co-insurance.
Yet the VA , whose population is at highest risk, still refuses to
implement this life-saving benefit system-wide.
Since the median age of Gulf War veterans is now the mid-50's, LCA
would urge the committee to require the VA to immediately implement CT
lung cancer screening. Indeed, CT screening will provide more concrete
and accurate data on lung cancer, as well as data on heart disease and
other lung diseases, than the $500,000,000, 18-year Gulf War study has
to date.
NATIONAL GULF WAR RESOURCE CENTER
STATEMENT FOR THE RECORD OF RONALD E. BROWN, GULF WAR VETERAN &
PRESIDENT, NATIONAL GULF WAR RESOURCE CENTER
Thank you, Chairman Coffman, Ranking Member Kuster, and Members of
the House Veterans' Affairs Subcommittee on Oversight and
Investigations. I thank you for holding this investigative hearing on
Gulf War health issues on the eve of the 25th anniversary of our
successful ground invasion to liberate Kuwait.
My name is Ronald Brown; I'm President of the National Gulf War
Resource Center (NGWRC). The NGWRC is a small 501 (c) (3) non-profit
veteran service organization, which is comprised of sick Persian Gulf
War veterans who volunteer our time to advocate for our fellow veterans
suffering from the complexities of modern warfare. We specialize in
Gulf War Illness claims, we work with veterans to educate and assist
them in the claims process. We also work with policy makers inside the
VA, in an attempt to accomplish two goals: first, to insure clinicians
are better trained about conditions facing this group of veterans to
insure the veterans receive the best health care possible.
Secondly, we are working to address and correct issues affecting
this group of veterans, such as the high denial rate of Gulf War
illness related claims.
We also strive to inform veterans concerning ongoing research being
conducted by both the Department of Veterans Affairs and the
Congressionally Directed Medical Research Programs (CDMRP). We strive
to get veterans involved in the research as participants.
In my view, the Congressionally Directed Medical Research Program
(CDMRP) is by far leading the way on research for our sick Gulf War
veterans. Many studies funded by the CDMRP have shown promise that may
provide insight into Gulf War illness.These studies may eventually
identify ways to diagnose and treat Gulf War Illness. Additional
follow-up (replication on a larger scale) is needed on these promising
pilot studies. Unfortunately, in our view, the VA Office of Research
and Development (ORD) have been slow to replicate any of these
promising pilot studies. Until this is done, these studies will not
benefit veterans by providing effective treatments or new presumptive
conditions for benefits.
Recently, I attended the public briefing for The Gulf War and
Health, Volume 10: Update of Health Effects of Serving in the Gulf War.
While I agree with the committee's recommendation to use the term Gulf
War Illness (GWI), overall I was shocked and troubled by the
conclusions and recommendations this committee reached.
This committee suggest that the ``conditions associated with Gulf
War deployment are primarily mental health disorders and functional
medical disorders and that these associations emphasize the
interconnectedness of the brain and body (page 11, IOM vol 10).'' This
committee also stated ``Veterans who were deployed to the Gulf War do
not appear to have an increased risk for many long term health
conditions with the exceptions of Post-Traumatic Stress Disorder
(PTSD), Gulf War Illness (GWI), Chronic Fatigue Syndrome (CFS),
Functional Gastrointestinal conditions, generalized anxiety disorder,
depression and substance abuse.''
The committee added further insult to sick Desert Storm veterans
when they recommended: ``Further studies to assess the increased
incidence and prevalence of circulatory, hematologic, musculoskeletal,
gastrointestinal, genitourinary, reproductive, endocrine and metabolic,
respiratory, chronic skin, and mental health conditions due to
deployment in the Gulf War should not be undertaken. Rather, future
research related to these conditions should focus on ensuring that Gulf
War veterans receive timely and effective treatment (page 9, IOM vol
10).'' This committee recommended that future research should focus on
treating and managing Gulf War illness rather than its causes.
I agree treatments and managing Gulf War illness is important;
however, I also believe that we should understand the causes of this
illness in Desert Storm veterans if we are to prevent toxic illness and
injury to future generations of our Armed forces. This committee
recommended individual and environmental biomonitoring during future
conflicts. I agree with this recommendation with skepticism based on
DOD's history of reluctance to release information concerning exposures
during Desert Storm.
I strongly disagree with this committee's recommendation that
``further studies to assess the increased incidence and prevalence of
health conditions due to deployment in the Gulf War should not be
undertaken.'' If this committee has their way, I'm afraid we never will
learn what caused our illness, how to treat ill Persian Gulf Veterans,
and we will never have the evidence to warrant adding new presumptive
conditions.
Since 2002, sick Desert Storm veterans who have attended, or listen
in by phone, to the Research Advisory Committee (RAC) meetings have
listened to presentations that show VA epidemiological studies have
shown that deployed Desert Storm veterans have higher prevalence of:
Migraine headaches (20.3% deployed vs 16.1% non-
deployed).
Chronic obstructive pulmonary disease (8.4% deployed vs
6.3% non-deployed).
Dermatitis (27.4% deployed vs 21.1% non-deployed).
Functional dyspepsia (27.7% deployed vs 15.9% non-
deployed).
Tachycardia (8.1% deployed vs 5.9% non-deployed).
Irritable bowel syndrome (24.4% deployed vs 14.3% non-
deployed).
Yet, the IOM committee puts many of these issues listed above in
its Inadequate/Insufficient Evidence to Determine Whether an
Association Exist category.
There is most definitely a problem with this committee's report as
the VA's own research shows one thing, and the IOM committee is saying
something completely different. This report is an injustice to sick
Desert Storm veterans. This report winds the clock backwards to the
1994 mindset. In 1994 the VA as well as the Department of Defense (DOD)
said that GWI was nothing more than combat stress, PTSD, or
psychological illnesses. Desert Storm veterans thought we had escaped
the ``it's all in your head'' mindset with the ground breaking 2008
Research Advisory Committee report. Yet here we are twenty-five years
after the war, and sick Desert Storm veterans are still waiting for
treatments, many are still waiting on service connection for
presumptive conditions per current law, and we still wait and hope new
presumptive conditions will be added.
My reasoning for my belief that there is a problem with this
committee's report is during the briefing when I asked why studies that
showed cancer at higher rates weren't considered by this committee,
URMC Professor Deborah Cory-Slechta referenced the 2004 GOA report that
stated the Khamisiyah plume model was flawed that was used in VA's
research. This same GOA report also stated that the VA and DOD's
hospital rate study was also flawed, yet this committee still used this
study to reach their conclusions (page 200, IOM vol 10).
This IOM committee retrieved over 280 studies of potential
relevance to this report. 204 studies that ``did not appear to have
immediate relevance, based on an assessment of the title and abstract''
were deleted without consideration leaving only 76 potential relevant
studies considered and discussed by this committee (page 25, IOM vol
10). Nowhere in this report are these 204 deleted studies listed. My
question is how many of these deleted studies were VA and CDMRP
studies? An additional 100 papers dealing with animal models were
reviewed and half were deleted for further consideration (page 26, IOM
vol 10). Of the half that was not considered, how many were VA and
CDMRP papers?
The NGWRC honestly feels this report is flawed. We are grateful
that the House Veterans' Affairs Subcommittee on Oversite and
Investigation has decided to investigate this matter.
Recommendations:
(1). Ensure any future contract between the VA and IOM is made
public for Desert Storm veterans. This would ensure transparency.
(2). To further ensure transparency Veterans Service Organizations
(VSO) should be invited to the IOM's briefing to the Department of
Veterans Affairs.
(3). Veterans Service Organizations should receive a copy of future
IOM reports prior to the public briefing. This will allow the VSOs to
form reasonable questions for the committee.
(4). Ensure the IOM committee list all studies they deem not
relevant in its report. A reasonable explanation as to why the study
was found irrelevant should be provided. This would ensure researchers
knowledge of the IOM's definition of ``immediate relevance''.
(5). Desert Storm veterans and our researchers need help in regards
to replication on a larger scale of studies that have shown promise.
Unfortunately, the VA Office of Research and Development (ORD) have
been slow to replicate any of these promising pilot studies. If the VA
is unable to replicate this amazing and promising research, then
perhaps increased funding should be provided to the CDMRP to replicate
these promising studies on a larger scale. Until this is done, these
small promising pilot studies will not benefit veterans by providing
effective treatments or new presumptive conditions for benefits.
Respectfully,
Ronald E. Brown President
National Gulf War Resource Center
JAMES BINNS
With respect to Gulf War veterans' health, VA pays no more
attention to Congress than it does to science. As described below,
Congress has ordered report after report from the Institute of Medicine
(IOM), specifying in law the work to be done. However, VA has
consistently failed to contract for what Congress actually ordered. The
IOM has been a willing accomplice, changing its own standards of
evidence and appointing biased committees to accommodate VA's purposes.
As a result, the reports inevitably produce conclusions that deny any
connection between toxic exposures and the shattered health of Gulf War
veterans, and promote the discredited 1990's VA position that their
illness is largely psychiatric.
These same corrupt practices have been employed to deny the effect
of toxic exposures from burn pits on the health of recent Iraq and
Afghanistan veterans.
1. Public Laws 105-277 and 105-368, enacted in 1998, are the
foundation for the IOM Gulf War and Health reports. Congress required
VA to contract with the IOM to evaluate the health risks of thirty-
three toxic substances and medications to which troops were exposed in
the war. The law required consideration of animal studies because most
studies of the effects of toxic substances are necessarily done in
animals.
But VA did not contract for consideration of animal studies, and
the IOM actually changed its standards of evidence to exclude animal
studies - the exact opposite of what Congress ordered. As a result,
these studies - the basic studies that show these toxic substances are
toxic--have never been considered in any IOM report, and no IOM report
has ever found sufficient evidence that any of the thirty-three toxic
agents are associated with health problems.
The entire IOM Gulf War series of reports is a house of cards, as
detailed in Appendix A.
These same corrupt practices have been employed to deny the effect
of toxic exposures from burn pits on the health of recent Iraq and
Afghanistan veterans. (below, pp. 12-13)
2. In 2010, in Public Law 111-275, Congress required VA to contract
with the IOM for a ``comprehensive review of the best treatments for
chronic multisymptom illness in Gulf War veterans.''
The statute directed that the IOM ``shall convene a group of
medical professionals who are experienced in treating [Gulf War
veterans] who have been diagnosed with chronic multisymptom illness or
another health condition related to chemical and environmental
exposures . . .'' \1\
---------------------------------------------------------------------------
\1\ Veterans Benefits Act of 2010, Sec. 805, http://
library.clerk.house.gov/reference-files/PPL--111--275--
VeteransBenefitsAct--2010.pdf
---------------------------------------------------------------------------
VA ignored this direction and instead contracted with the IOM for a
literature review of largely psychiatric diseases by a committee with
no experience in treating Gulf War veterans, heavily weighted with
specialists in psychosomatic medicine and stress. \2\ Rather than
capturing the valuable treatment experience of Gulf War veterans'
doctors, as Congress intended, the resulting 2013 IOM treatment report
was a restatement of government fictions from the 1990's, foreshadowing
the 2016 IOM report and the new VA/DoD Clinical Practice Guideline.
---------------------------------------------------------------------------
\2\ http://www.scribd.com/doc/150949964/WHITE-PAPER-IOM-CMI-Panel-
Membership-Analysis
---------------------------------------------------------------------------
3. In 2008, Congress enacted Public Law 110-389 requiring VA to
contract with the IOM ``to conduct a comprehensive epidemiological
study . [to] identify the incidence and prevalence of diagnosed
neurological diseases, including multiple sclerosis, Parkinson's
disease, and brain cancers . . .'' in 1991 Gulf War veterans, Post-9/11
Global Operations veterans, and non-deployed comparison groups. \3\
---------------------------------------------------------------------------
\3\ Public Law 110-389, Section 804
---------------------------------------------------------------------------
For seven years, VA refused to contract for the study, despite
repeated urging by the Research Advisory Committee on Gulf War Veterans
Illnesses. \4\ In 2015, VA finally contracted with the IOM, but wrote
in the contract that the IOM could only use VA data. The IOM committee
declined to proceed with the study because the VA data was insufficient
for a rigorous study. \5\
---------------------------------------------------------------------------
\4\ http://www.va.gov/RAC-GWVI/docs/Committee--Documents/
CommitteeDocJune2012.pdf (Appendix E)
\5\ http://iom.nationalacademies.org/Reports/2015/Considerations-
for-Designing-Epidemiologic-Study-for-Multiple-Sclerosis-and-other-
Neurological-disorders-Veterans.aspx
---------------------------------------------------------------------------
In the absence of the study ordered by Congress in 2008, the 2016
report found the evidence insufficient to reach conclusions that these
conditions are associated with Gulf War service. \6\
---------------------------------------------------------------------------
\6\ 2016 IOM Gulf War and Health report, pp. 102,145,149.
---------------------------------------------------------------------------
4. The membership of IOM Gulf War report committees has usually
been biased toward VA's discredited position, including the 2016
committee.
See the November 2014 letter to Dr. Victor Dzau, president of the
IOM, attached as Appendix B below (pp. 37-42), objecting to the makeup
of the 2016 Gulf War and Health committee. ``[T]he membership is
grossly imbalanced toward the 1990's government position that Gulf War
veterans have no special health problem - just what happens after every
war, related to psychiatric issues, and not environmental exposures.''
The letter documented that eight the members of the committee were
associated with the 1990's government position, including the former
1990's VA Undersecretary for Health, Dr. Kenneth Kizer, who was the
chief advocate for the position. Eight members were neutral. Subsequent
to the letter, one neutral member resigned and one individual with
current Gulf War research experience was added, the only person on the
committee with such experience.
The last two pages of the letter analyze the 2016 committee
membership. (below, pp. 45-46)
The letter predicted that: ``Reviving this discredited fiction will
cause veterans' doctors to prescribe inappropriate psychiatric
medications, and will misdirect research to find effective treatments
down blind alleys - an unconscionable breach of the duty owed to
veterans and expected of the Institute of Medicine. ``
Appendix A
VA and IOM Collaboration To Exclude Consideration Of Animal Studies
Required By Law
Public Laws 105-277 and 105-368 are the foundation for the
Institute of Medicine (IOM) Gulf War and Health reports. Congress
required VA to contract with the IOM to evaluate the health risks of
thirty-three toxic substances and medications to which troops were
exposed in the war. The law required consideration of animal studies on
a par with human studies because most studies of toxic substances are
necessarily done in animals for ethical reasons.
But VA did not contract for consideration of animal studies, and
the IOM actually changed its standards of evidence to exclude animal
studies - the exact opposite of what Congress ordered. As a result,
these studies - the basic studies that show these toxic substances are
toxic--have never been considered in any IOM report, and no IOM report
has ever found sufficient evidence that any of the thirty-three listed
toxic agents are associated with health problems.
Consider, for example, the twenty-three animal studies on pages
160-161 of the 2008 report of the Research Advisory Committee on Gulf
War Veterans Illnesses, showing that low levels of nerve gas, below the
level that causes symptoms at the time of exposure, cause long-term
adverse health effects, contrary to what was believed at the time of
the war. Because of these studies, an update report on the effects of
sarin was ordered from the IOM, but as described below, VA and IOM
staff conspired to ensure that the report would not consider animal
studies in its conclusions, even though new animal studies were the
only reason for ordering the report.
http://www.va.gov/RAC-GWVI/docs/Committee--Documents/
GWIandHealthofGWVeterans--RAC-GWVIReport--2008.pdf
The entire IOM Gulf War series of reports is a house of cards, as
detailed below.
These same corrupt practices have been employed to deny the effect
of toxic exposures from burn pits on the health of recent Iraq and
Afghanistan veterans. (below, pp. 12-13)
* * *
These 1998 statutes required the IOM to identify illnesses
experienced by Armed Forces members who served in the war, ``including
diagnosed illnesses and undiagnosed illnesses'' (the term then used for
what is now called ``Gulf War Illness''). The statutes then asked, for
each of the thirty-three agents and each illness, ``whether a
statistical association exists between exposure to an agent . . . and
an increased risk of illness in human or animal populations.''
Congress required consideration of studies in animals because most
studies of toxic substances and drugs are necessarily done in animals
for ethical reasons. It did not ask for information on how much of an
agent Gulf War troops were exposed to. It was well known that no such
information exists.
These basic animal studies have never been considered in any IOM
report. The 2016 report discusses some animal studies involving
exposures to combinations of agents, but it acknowledges that ``studies
examining single exposures are not considered here'' because ``[e]arly
volumes of the Gulf War and Health series described animal studies . .
. on the association between exposure to a single toxicant and the
health outcomes that may result. . .''
2016 IOM Gulf War and Health report, Vol. 10, p. 239
But the earlier IOM reports make clear they did not consider these
animal studies in their conclusions. The chairman of the 2016
committee, Dr. Deborah Cory-Slechta, was a member of the committee for
the 2003 IOM Gulf War report on Insecticides and Solvents, so she is
familiar with the procedures used. While the 2003 report ``described''
numerous animal studies, it admitted that ``animal studies had a
limited role in the committee's assessment between exposure and a
health outcome. Animal data . . . were not used as part of the weight-
of-evidence . . .''
2003 IOM Gulf War and Health report, Vol. 2, p. 3
The same admission can be found in every IOM Gulf War report on the
health effects of toxic substances. Thus, the 2016 report did not
consider these basic animal studies in their conclusions, relying on
the earlier reports, but the earlier reports didn't consider them
either. As a result, since most studies of toxic exposures are done in
animals, no IOM report has ever found sufficient evidence that any of
the thirty-three listed toxic exposures and medications are associated
with adverse health outcomes.
The whole IOM Gulf War series of reports is a house of cards.
In her preface to the 2016 report, Dr. Cory-Slechta points to the
``ever unknowable impact of the various chemical exposures that
occurred. . .'', because ``[o]bjective exposure data gathered during
and after the war have been, and are expected to continue to be,
unavailable.'' 2016 IOM Gulf War and Health report, Vol. 10, p. ix
But Congress never asked for consideration of exposure data. It was
well known that data did not exist. What it did ask for was
consideration of animal data. But it has never gotten it. It has never
gotten it because VA did not contract for the reports that Congress
ordered.
The IOM has been a willing collaborator in this deceit, changing
its own standards of evidence to exclude animal studies - exactly the
opposite action from what the law required.
It made this change quietly, and has deceitfully implied that
nothing changed. As presented in the 2003 report, ``[t]he committee
used the [standards of evidence] from previous IOM studies because they
have gained wide acceptance over more than a decade by Congress,
government agencies, researchers, and veterans groups.'' ``The
[standards of evidence] closely resemble those used by . . . IOM
committees that have evaluated . . . herbicides used in Vietnam.'' 2003
IOM Gulf War and Health report, Vol. 2, p. 3
(See the similar language on p. 3 of the 2016 report.)
In fact, however, the standards were subtly changed from the Agent
Orange standards to exclude consideration of animal studies. Animal
studies are discussed in the Gulf War reports, but when it comes to
arriving at the reports' conclusions, they are not considered, applying
the doctored standards of evidence (what the IOM calls the ``categories
of association'').
For sixteen years, VA, DoD, and IOM staff have manipulated IOM Gulf
War reports on the health effects of veterans' toxic exposures. As a
result, the reports have consistently found ``insufficient evidence''
that the exposures are associated with illness, leading to VA
determinations that the illness does not qualify for benefits as
service-connected. Of equal importance, these dishonest reports have
also misled researchers seeking to understand the causes of Gulf War
illness in order to identify treatments to improve veterans' health and
preventive measures to protect future US forces.
In recent years, the same techniques have been applied to IOM
reports on the health effects of toxic substances released by burn pits
on recent Iraq and Afghanistan veterans.
The balance of this Appendix will review in detail these corrupt
practices.
1. The governing statute expressly requires consideration of animal
studies.
In PL 105-277 and PL 105-368, Congress in 1998 directed the
Department of Veterans Affairs to contract with the National Academy of
Sciences (NAS, the parent organization of the Institute of Medicine,
IOM), to review the scientific literature regarding substances to which
troops were exposed in the 1991 Gulf War 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 (IOM) 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). [attached to this Appendix below at p. 14] 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). [below, pp. 15-16] The law
further required the NAS (IOM) 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) [below, p. 14]
``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) [below, p. 16, 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) [below, p. 21, 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 necessarily 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 2008
Research Advisory Committee on Gulf War Veterans Illnesses report, all
of which were done in animals. http://www.va.gov/RAC-GWVI/docs/
Committee--Documents/GWIandHealthofGWVeterans--RAC-GWVIReport--2008.pdf
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, (2000), p. 72 [below, p. 23]
Considering only human studies, and not the much larger relevant
literature on animal studies, the IOM committees have never found
sufficient evidence of an association for the exposures and illnesses
experienced by Gulf War veterans. Following the reports of the IOM, the
Secretary of Veterans Affairs has made no determinations of service-
connection for these exposures and illnesses for veterans' benefits.
(VA asserts that it covers Gulf War veterans on other grounds for their
``undiagnosed illnesses,'' but VA statistics show that over 80% of such
veterans' claims are denied. http://www.scribd.com/doc/241661207/Binns-
Parting-Thoughts-093014)
This pattern has been followed in all IOM Gulf War reports to date.
More recently, it has been applied to IOM reports on the effects of
toxic exposures fromburn pits on the health of recent Iraq and
Afghanistan veterans.
2. The exclusion of animal studies was deliberate.
A close examination of what occurred makes clear that the exclusion
of animal studies was not 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
standards of evidence, which it called the ``Categories of
Association.'' Gulf War and Health, Vol. 1, pp. 83-84. [below, pp. 25-
26] 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.'' ``The categories closely resemble those used by several IOM
committees that evaluated .. herbicides used in Vietnam .'' Gulf War
and Health, Volume I, p. 83. [below, p. 25]
IOM Gulf War reports have repeatedly emphasized 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 [below, p. 27, 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 [below, p. 25, 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 [below, p. 25]
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. [below, p. 25, 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, below pp. 20-21]
In short, in direct contravention of the law, 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 veterans' benefits.
3. VA and IOM staff privately collaborated to produce these
results.
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
these reports' 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, not humans.
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 Anthony Principi wrote the president of 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.'' [attached, p. 29]
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. 18 [below, p. 30] Accordingly, the report
found insufficient evidence of an association.
To understand this bizarre outcome, it is revealing that following
Secretary Principi's letter, an IOM proposal was prepared which became
the basis for a contract between the IOM and VA.
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, part of the Office of Public Health. 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.'' [below, p. 31]
The proposal contained the following ``Statement of Task'': [below,
p. 34]
``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. [below, p. 26] 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.) They must have come from the
``conversations with yourself'' referred to in Ms. Stoiber's letter to
Dr. Brown. Thus, conversations between VA and IOM staff determined the
outcome of the report before the IOM committee to prepare the report
was ever appointed.
In summary, VA and the IOM have not complied with the law requiring
the IOM Gulf War reports, 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. Dr. Brown and Ms. Stoiber are long
gone, and their successors are more careful regarding what they put in
writing, but the corrupted Categories of Asssociation and all the IOM
reports based on them still stand.
4. The IOM has recently applied this same corrupt standard to the
health of recent Iraq and Afghanistan veterans, denying the adverse
effects of toxic substances released by burn pits.
In 2007 on-site military officers with environmental health
responsibilities reported dangerous health effects of toxic exposures
from burn pits on U.S. bases in Iraq and Afghanistan, particularly
Joint Base Balad (JBB). A draft executive summary of a study, dated
December 2007, showed dioxin levels at 51 times acceptable levels,
particulate exposure at 50 times acceptable levels, volatile compounds
at two times acceptable levels, and cancer risk from exposure to
dioxins at two times acceptable levels for people at Balad for a year
and at eight times acceptable levels for people at the base for more
than a year.
DoD Washington said the draft summary contained ``incorrect data''
due to a ``software error'' and was ``prematurely distributed.''
Officials in Washington in the DoD Office of Force Health Protection
and Readiness denied any lasting health effects: ``While exposure to
burn pit smoke may cause temporary coughing and redness or stinging of
the eyes, extensive environmental monitoring indicates that smoke
exposures not interfering with breathing or requiring medical treatment
at the time of exposure usually do not cause any lasting health effects
or medical follow-up.'' http://www.armytimes.com/article/20081027/NEWS/
810270315/Burn-pit-at-Balad-raises-health-concerns
An IOM report was ordered by VA to study the subject. ``[T]he
Institute of Medicine has embarked on a comprehensive study with noted
experts in environmental and occupational health to study the issue.''
``Is Burn Pit Smoke Hazardous To Your Health?'', Force Health
Protection and Readiness magazine, vol. 5, issue 2, 2010, page 11.
http://home.fhpr.osd.mil/Libraries/FHPR--Online--Magazine/Volume--
5--Issue--2.sflb.ashx
Following the pattern established in the IOM Gulf War reports, the
IOM burn pit report first pointed out the known health risks of the
exposures: ``Chemicals in all three major classes of chemicals detected
at JBB . . . have been associated with long-term health effects. A wide
array of health effects have been observed in humans and animals after
exposure to the specific pollutants detected at JBB . . . The health-
effects data on the other pollutants detected include: neurological
effects, liver toxicity and reduced liver function, cancer, respiratory
toxicity and morbidity, kidney toxicity and reduced kidney function,
blook effects, cardiovascular toxicity and morbidity, reproductive and
developmental toxicity.'' http://books.nap.edu/openbook.php?record--
id=13209&page=5
But then, when it came to arriving at conclusions, the IOM
committee applied the Categories of Association that allowed only for
consideration of human studies. It stated that it was ``[f]ollowing the
methods and criteria used by other IOM committees that have prepared
reports for the Gulf War and Health Series and the Veterans and Agent
Orange Series . . .'') http://books.nap.edu/openbook.php?record--
id=13209&page=6).
There were no published studies of service members exposed to burn
pits, so the committee relied on studies of groups like firefighters
and incinerator workers. Accordingly, as reported on VA's website, the
committee found only ``limited but suggestive evidence of a link
between exposure to combustion products and reduced lung function'' and
``inadequate or insufficient evidence of a relation to combustion
products and cancer, respiratory diseases, circulatory diseases,
neurological diseases, and adverse reproductive and developmental
outcomes.'' It did not find the ``sufficient evidence of an
association'' required for service connection.
http://www.publichealth.va.gov/exposures/burnpits/health-effects-
studies.asp
Thus, rigging IOM reports by corrupting the Categories of
Association has been extended to a new generation of veterans, as well
as continuing for Gulf War veterans.
ATTACHMENTS TO APPENDIX A
TITLE 38--VETERANS' BENEFITS,
PART II--GENERAL BENEFITS
CHAPTER 11--COMPENSATION FOR SERVICE-CONNECTED DISABILITY OR DEATH,
SUBCHAPTER II--WARTIME DISABILITY COMPENSATION
Sec. 1117. Compensation for disabilities occurring in Persian Gulf
War veterans
* * *
Agreement With National Academy of Sciences Regarding Toxic Drugs
and Illnesses Associated With Gulf War
Pub. L. 105-277, div. C, title XVI, Sec. 1603-1605, Oct. 21, 1998,
112 Stat. 2681-745 to 2681-748, as amended by Pub. L. 107-103, title
II, Sec. 202(d)(2), Dec. 27, 2001, 115 Stat. 989, provided that:
``SEC. 1603. AGREEMENT WITH NATIONAL ACADEMY OF SCIENCES.
``(a) Purpose.--The purpose of this section is to provide for the
National Academy of Sciences, an independent nonprofit scientific
organization with appropriate expertise, to review and evaluate the
available scientific evidence regarding associations between illnesses
and exposure to toxic agents, environmental or wartime hazards, or
preventive medicines or vaccines associated with Gulf War service.
``(b) Agreement.--The Secretary of Veterans Affairs shall seek to
enter into an agreement with the National Academy of Sciences for the
Academy to perform the activities covered by this section. The
Secretary shall seek to enter into the agreement not later than two
months after the date of enactment of this Act [Oct. 21, 1998].
``(c) Identification of Agents and Illnesses.--(1) Under the
agreement under subsection (b), the National Academy of Sciences
shall----
``(A) identify the biological, chemical, or other toxic agents,
environmental or wartime hazards, or preventive medicines or vaccines
to which members of the Armed Forces who served in the Southwest Asia
theater of operations during the Persian Gulf War may have been exposed
by reason of such service; and
``(B) identify the illnesses (including diagnosed illnesses and
undiagnosed illnesses) that are manifest in such members.
``(2) In identifying illnesses under paragraph (1)(B), the Academy
shall review and summarize the relevant scientific evidence regarding
illnesses among the members described in paragraph (1)(A) and among
other appropriate populations of individuals, including mortality,
symptoms, and adverse reproductive health outcomes among such members
and individuals.
``(d) Initial Consideration of Specific Agents.--(1) In identifying
under subsection (c) the agents, hazards, or preventive medicines or
vaccines to which members of the Armed Forces may have been exposed for
purposes of the first report under subsection (i), the National Academy
of Sciences shall consider, within the first six months after the date
of enactment of this Act [Oct. 21, 1998], the following:
``(A) The following organophosphorous pesticides:
``(i) Chlorpyrifos.
``(ii) Diazinon.
``(iii) Dichlorvos.
``(iv) Malathion.
``(B) The following carbamate pesticides:
``(i) Proxpur.
``(ii) Carbaryl.
``(iii) Methomyl.
``(C) The carbamate pyridostigmine bromide used as nerve agent
prophylaxis.
``(D) The following chlorinated hydrocarbon and other pesticides
and repellents:
``(i) Lindane.
``(ii) Pyrethrins.
``(iii) Permethrins.
``(iv) Rodenticides (bait).
``(v) Repellent (DEET).
``(E) The following low-level nerve agents and precursor compounds
at exposure levels below those which produce immediately apparent
incapacitating symptoms:
``(i) Sarin.
``(ii) Tabun.
``(F) The following synthetic chemical compounds:
``(i) Mustard agents at levels below those which cause immediate
blistering.
``(ii) Volatile organic compounds.
``(iii) Hydrazine.
``(iv) Red fuming nitric acid.
``(v) Solvents.
``(vi) Uranium.
``(G) The following ionizing radiation:
``(i) Depleted uranium.
``(ii) Microwave radiation.
``(iii) Radio frequency radiation.
``(H) The following environmental particulates and pollutants:
``(i) Hydrogen sulfide.
``(ii) Oil fire byproducts.
``(iii) Diesel heater fumes.
``(iv) Sand micro-particles.
``(I) Diseases endemic to the region (including the following):
``(i) Leishmaniasis.
``(ii) Sandfly fever.
``(iii) Pathogenic escherechia coli.
``(iv) Shigellosis.
``(J) Time compressed administration of multiple live,
`attenuated', and toxoid vaccines.
``(2) The consideration of agents, hazards, and medicines and
vaccines under paragraph (1) shall not preclude the Academy from
identifying other agents, hazards, or medicines or vaccines to which
members of the Armed Forces may have been exposed for purposes of any
report under subsection (i).
``(3) Not later than six months after the date of enactment of this
Act [Oct. 21, 1998], the Academy shall submit to the designated
congressional committees a report specifying the agents, hazards, and
medicines and vaccines considered under paragraph (1).
``(e) Determinations of Associations Between Agents and
Illnesses.----
(1) For each agent, hazard, or medicine or vaccine and illness
identified under subsection (c), the National Academy of Sciences shall
determine, to the extent that available scientific data permit
meaningful determinations----
``(A) whether a statistical association exists between exposure to
the agent, hazard, or medicine or vaccine and the illness, taking into
account the strength of the scientific evidence and the appropriateness
of the scientific methodology used to detect the association;
``(B) the increased risk of the illness among human or animal
populations exposed to the agent, hazard, or medicine or vaccine; and
``(C) whether a plausible biological mechanism or other evidence of
a causal relationship exists between exposure to the agent, hazard, or
medicine or vaccine and the illness.
``(2) The Academy shall include in its reports under subsection (i)
a full discussion of the scientific evidence and reasoning that led to
its conclusions under this subsection.
``(f) Review of Potential Treatment Models for Certain Illnesses.--
--Under the agreement under subsection (b), the National Academy of
Sciences shall separately review, for each chronic undiagnosed illness
identified under subsection (c)(1)(B) and for any other chronic illness
that the Academy determines to warrant such review, the available
scientific data in order to identify empirically valid models of
treatment for such illnesses which employ successful treatment
modalities for populations with similar symptoms.
``(g) Recommendations for Additional Scientific Studies.--(1) Under
the agreement under subsection (b), the National Academy of Sciences
shall make any recommendations that it considers appropriate for
additional scientific studies (including studies relating to treatment
models) to resolve areas of continuing scientific uncertainty relating
to the health consequences of exposure to toxic agents, environmental
or wartime hazards, or preventive medicines or vaccines associated with
Gulf War service.
``(2) In making recommendations for additional studies, the Academy
shall consider the available scientific data, the value and relevance
of the information that could result from such studies, and the cost
and feasibility of carrying out such studies.
``(h) Subsequent Reviews.--(1) Under the agreement under subsection
(b), the National Academy of Sciences shall conduct on a periodic and
ongoing basis additional reviews of the evidence and data relating to
its activities under this section.
``(2) As part of each review under this subsection, the Academy
shall----
``(A) conduct as comprehensive a review as is practicable of the
evidence referred to in subsection (c) and the data referred to in
subsections (e), (f), and (g) that became available since the last
review of such evidence and data under this section; and
``(B) make determinations under the subsections referred to in
subparagraph (A) on the basis of the results of such review and all
other reviews previously conducted for purposes of this section.
``(i) Reports.--(1) Under the agreement under subsection (b), the
National Academy of Sciences shall submit to the committees and
officials referred to in paragraph (5) periodic written reports
regarding the Academy's activities under the agreement.
``(2) The first report under paragraph (1) shall be submitted not
later than 18 months after the date of enactment of this Act [Oct. 21,
1998]. That report shall include----
``(A) the determinations and discussion referred to in subsection
(e);
``(B) the results of the review of models of treatment under
subsection (f); and
``(C) any recommendations of the Academy under subsection (g).
``(3) Reports shall be submitted under this subsection at least
once every two years, as measured from the date of the report under
paragraph (2).
``(4) In any report under this subsection (other than the report
under paragraph (2)), the Academy may specify an absence of meaningful
developments in the scientific or medical community with respect to the
activities of the Academy under this section during the 2-year period
ending on the date of such report.
``(5) Reports under this subsection shall be submitted to the
following:
``(A) The designated congressional committees.
``(B) The Secretary of Veterans Affairs.
``(C) The Secretary of Defense.
``(j) Sunset.--This section shall cease to be effective on October
1, 2010.
``(k) Alternative Contract Scientific Organization.--(1) If the
Secretary is unable within the time period set forth in subsection (b)
to enter into an agreement with the National Academy of Sciences for
the purposes of this section on terms acceptable to the Secretary, the
Secretary shall seek to enter into an agreement for purposes of this
section with another appropriate scientific organization that is not
part of the Government, operates as a not-for-profit entity, and has
expertise and objectivity comparable to that of the National Academy of
Sciences.
``(2) If the Secretary enters into an agreement with another
organization under this subsection, any reference in this section and
section 1118 of title 38, United States Code (as added by section
1602(a)), to the National Academy of Sciences shall be treated as a
reference to such other organization.
``SEC. 1604. REPEAL OF INCONSISTENT PROVISIONS OF LAW.
``In the event of the enactment, before, on, or after the date of
the enactment of this Act [Oct. 21, 1998], of section 101 of the
Veterans Programs Enhancement Act of 1998 [Pub. L. 105-368, 112 Stat.
3317], or any similar provision of law enacted during the second
session of the 105th Congress requiring an agreement with the National
Academy of Sciences regarding an evaluation of health consequences of
service in Southwest Asia during the Persian Gulf War, such section 101
(or other provision of law) shall be treated as if never enacted, and
shall have no force or effect.
``SEC. 1605. DEFINITIONS.
``In this title [enacting section 1118 of this title, amending this
section and section 1113 of this title, and enacting this note and
provisions set out as a note under section 101 of this title]:
``(1) The term `toxic agent, environmental or wartime hazard, or
preventive medicine or vaccine associated with Gulf War service' means
a biological, chemical, or other toxic agent, environmental or wartime
hazard, or preventive medicine or vaccine that is known or presumed to
be associated with service in the Armed Forces in the Southwest Asia
theater of operations during the Persian Gulf War, whether such
association arises as a result of single, repeated, or sustained
exposure and whether such association arises through exposure
singularly or in combination.
``(2) The term `designated congressional committees' means the
following:
``(A) The Committees on Veterans' Affairs and Armed Services of the
Senate.
``(B) The Committees on Veterans' Affairs and National Security
[now Armed Services] of the House of Representatives.
``(3) The term `Persian Gulf War' has the meaning given that term
in section 101(33) of title 38, United States Code.''
[Pub. L. 105-368, title I, Sec. 101, Nov. 11, 1998, 112 Stat. 3317,
enacted provisions similar to those in sections 1603 and 1605 of Pub.
L. 105-277, set out above. See section 1604 of Pub. L. 105-277, set out
above.]
From the U.S. Code Online via GPO Access
[www.gpoaccess.gov]
[Laws in effect as of January 3, 2007]
[CITE: 38USC1118]
TITLE 38--VETERANS' BENEFITS
PART II--GENERAL BENEFITS
CHAPTER 11--COMPENSATION FOR SERVICE-CONNECTED DISABILITY OR DEATH
SUBCHAPTER II--WARTIME DISABILITY COMPENSATION
Sec. 1118. Presumptions of service connection for illnesses
associated with service in the Persian Gulf during the Persian Gulf War
(a)(1) For purposes of section 1110 of this title, and subject to
section 1113 of this title, each illness, if any, described in
paragraph (2) shall be considered to have been incurred in or
aggravated by service referred to in that paragraph, notwithstanding
that there is no record of evidence of such illness during the period
of such service.
(2) An illness referred to in paragraph (1) is any diagnosed or
undiagnosed illness that----
(A) the Secretary determines in regulations prescribed under this
section to warrant a presumption of service connection by reason of
having a positive association with exposure 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 Armed Forces in the Southwest Asia theater of operations during the
Persian Gulf War; and
(B) becomes manifest within the period, if any, prescribed in such
regulations in a veteran who served on active duty in that theater of
operations during that war and by reason of such service was exposed to
such agent, hazard, or medicine or vaccine.
(3) For purposes of this subsection, a veteran who served on active
duty in the Southwest Asia theater of operations during the Persian
Gulf War and has an illness described in paragraph (2) shall be
presumed to have been exposed by reason of such service to the agent,
hazard, or medicine or vaccine associated with the illness in the
regulations prescribed under this section unless there is conclusive
evidence to establish that the veteran was not exposed to the agent,
hazard, or medicine or vaccine by reason of such service.
(4) For purposes of this section, signs or symptoms that may be a
manifestation of an undiagnosed illness include the signs and symptoms
listed in section 1117(g) of this title.
(b)(1)(A) Whenever the Secretary makes a determination described in
subparagraph (B), the Secretary shall prescribe regulations providing
that a presumption of service connection is warranted for the illness
covered by that determination for purposes of this section.
(B) A determination referred to in subparagraph (A) is 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.
(2)(A) In making determinations for purposes of paragraph (1), the
Secretary shall take into account----
(i) the reports submitted to the Secretary by the National Academy
of Sciences under section 1603 of the Persian Gulf War Veterans Act of
1998; and
(ii) all other sound medical and scientific information and
analyses available to the Secretary.
(B) In evaluating any report, information, or analysis for purposes
of making such determinations, the Secretary shall take into
consideration whether the results are statistically significant, are
capable of replication, and withstand peer review.
(3) 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 positive for purposes of this subsection if
the credible evidence for the association is equal to or outweighs the
credible evidence against the association.
(c)(1) Not later than 60 days after the date on which the Secretary
receives a report from the National Academy of Sciences under section
1603 of the Persian Gulf War Veterans Act of 1998, the Secretary shall
determine whether or not a presumption of service connection is
warranted for each illness, if any, covered by the report.
(2) If the Secretary determines under this subsection that a
presumption of service connection is warranted, the Secretary shall,
not later than 60 days after making the determination, issue proposed
regulations setting forth the Secretary's determination.
(3)(A) If the Secretary determines under this subsection that a
presumption of service connection is not warranted, the Secretary
shall, not later than 60 days after making the determination, publish
in the Federal Register a notice of the determination. The notice shall
include an explanation of the scientific basis for the determination.
(B) If an illness already presumed to be service connected under
this section is subject to a determination under subparagraph (A), the
Secretary shall, not later than 60 days after publication of the notice
under that subparagraph, issue proposed regulations removing the
presumption of service connection for the illness.
(4) Not later than 90 days after the date on which the Secretary
issues any proposed regulations under this subsection, the Secretary
shall issue final regulations. Such regulations shall be effective on
the date of issuance.
(d) Whenever the presumption of service connection for an illness
under this section is removed under subsection (c)----
(1) a veteran who was awarded compensation for the illness on the
basis of the presumption before the effective date of the removal of
the presumption shall continue to be entitled to receive compensation
on that basis; and
(2) a survivor of a veteran who was awarded dependency and
indemnity compensation for the death of a veteran resulting from the
illness on the basis of the presumption before that date shall continue
to be entitled to receive dependency and indemnity compensation on that
basis.
(e) Subsections (b) through (d) shall cease to be effective on
September 30, 2011.
(Added Pub. L. 105-277, div. C, title XVI, Sec. 1602(a)(1), Oct.
21, 1998, 112 Stat. 2681-742; amended Pub. L. 107-103, title II, Sec.
202(b)(2), (d)(1), Dec. 27, 2001, 115 Stat. 989.)
References in Text
Section 1603 of the Persian Gulf War Veterans Act of 1998, referred
to in subsecs. (b)(2)(A)(i) and (c)(1), is section 1603 of Pub. L. 105-
277, which is set out in a note under section 1117 of this title.
Amendments
2001--Subsec. (a)(4). Pub. L. 107-103, Sec. 202(b)(2), added par.
(4).
Subsec. (e). Pub. L. 107-103, Sec. 202(d)(1), substituted ``on
September 30, 2011'' for ``10 years after the first day of the fiscal
year in which the National Academy of Sciences submits to the Secretary
the first report under section 1603 of the Persian Gulf War Veterans
Act of 1998''.
Effective Date of 2001 Amendment
Amendment by section 202(b)(2) of Pub. L. 107-103 effective Mar. 1,
2002, see section 202(c) of Pub. L. 107-103, set out as a note under
section 1117 of this title.
Gulf War and Health, Vol. 1, p. 72 [emphasis added]
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
(OTA, 1990).
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
(see below).
Human Studies
Epidemiologic Studies
Epidemiology concerns itself with the relationship of various
factors and conditions that determine the frequency and distribution of
an infectious process, a disease, or a physiological state in human
populations (Lilienfeld, 1978). Its focus on populations distinguishes
it from other medical disciplines. Epidemiologic studies characterize
the relationship between the agent, the environment, and the host and
are useful for generating and testing hypotheses with respect to the
association between exposure to an agent and health or disease. The
following section describes the major types of epidemiologic studies
considered by the committee.
Gulf War and Health, Vol. 2, p. 13 [emphasis added]
general use in the United States (PAC, 1996) at that time. However,
EPA has since placed restrictions on some of the insecticides used
during the Gulf War.
USE OF SOLVENTS IN THE GULF WAR
To determine the specific solvents used in the Gulf War the
committee gathered information from several sources, including
veterans, OSAGWI (2000), and DOD's Defense Logistics Agency. As a
result of its research, the committee ultimately identified 53 solvents
for review (Appendix D).
There is little information to characterize the use of solvents in
the Gulf War. Wartime uses of solvents (such as vehicle maintenance and
repair, cleaning, and degreasing) probably paralleled stateside
military or civilian uses of solvents, but operating conditions in the
Gulf War (such as ventilation and the use of masks) may have varied
widely from stateside working conditions.
The most thoroughly documented solvent exposure involved spray-
painting with chemical-agent-resistant coating (CARC) (OSAGWI, 2000).
Thousands of military vehicles deployed to the Gulf War were painted
with tan CARC to provide camouflage protection for the desert
environment and a surface that was easily decontaminated. Not all
military personnel involved in CARC painting were trained in spray-
painting operations, and some might not have had all the necessary
personal protective equipment (OSAGWI, 2000).
Personnel engaged in CARC painting were exposed to solvents in the
CARC formulations, paint thinners, and cleaning products. As noted in
the OSAGWI report, some of the solvents used to clean painting
equipment might have been purchased locally and therefore not
identified.
COMPLEXITIES IN ADDRESSING GULF WAR HEALTH ISSUES
Investigations of the health effects of past wars often focused on
narrowly defined hazards or health outcomes, such as infectious
diseases (for example, typhoid and malaria) during the Civil War,
specific chemical hazards (for example, mustard gas and Agent Orange)
in World War I and Vietnam, and combat injuries. Discussion of the
possible health effects of the Gulf War, however, involves many complex
issues, such as exposure to multiple agents, lack of exposure
information, nonspecific illnesses that lack defined diagnoses or
treatment protocols, and the experience of war itself. The committee
was not charged with addressing those issues, but it presents them here
to acknowledge the difficulties faced by veterans and their families,
researchers, policy-makers, and others in trying to understand Gulf War
veterans' health.
Multiple Exposures and Chemical Interactions
Military personnel were potentially exposed to numerous agents
during the Gulf War. The number of agents and the combination of agents
to which the veterans may have been exposed make it difficult to
determine whether any one agent or combination of agents is the cause
of the veterans' illnesses. These include preventive measures (such as
use of pyridostigmine bromide, vaccines, and insecticides), hazards of
the natural environment
Gulf War and Health, Vol. 1, p. 83 [emphasis added]
mittee evaluated the strength of the evidence for or against
associations between health effects and exposure to the agents being
studied.
Categories of Association
The committee used five previously established categories to
classify the evidence for association between exposure to a specific
agent and a health outcome. The categories closely resemble those used
by several IOM committees that evaluated vaccine safety (IOM, 1991,
1994a), herbicides used in Vietnam (IOM, 1994b, 1996, 1999), and indoor
pollutants related to asthma (IOM, 2000). Although the categories imply
a statistical association, the committee had sufficient epidemiologic
evidence to examine statistical associations for only one of the agents
under study (i.e., depleted uranium), there was very limited
epidemiologic evidence for the other agents examined (i.e., sarin,
pyridostigmine bromide, and anthrax and botulinum toxoid vaccines).
Thus, the committee based its conclusions on the strength and coherence
of the data in the available studies. In many cases, these data
distinguished differences between transient and long-term health
outcomes related to the dose of the agent. Based on the literature, it
became incumbent on the committee to similarly specify the differences
between dose levels and the nature of the health outcomes. This
approach led the committee to reach conclusions about long- and short-
term health effects, as well as health outcomes related to the dose of
the putative agents. The final conclusions expressed in Chapters 4-7
represent the committee's collective judgment. The committee endeavored
to express its judgments as clearly and precisely as the available data
allowed. 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.
- 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 fulfills the criteria for sufficient evidence of an
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.
- Limited/Suggestive Evidence of an Association. Evidence is
suggestive of an association between exposure to a specific agent and a
health outcome in humans, but is limited because chance, bias, and
confounding could not be ruled out with confidence.
Gulf War and Health, Vol. 1, p. 84 [emphasis added]
- Inadequate/Insufficient Evidence to Determine Whether an
Association Does or Does Not Exist. The available studies are of
insufficient quality, consistency, or statistical power to permit a
conclusion regarding the presence or absence of an association between
an exposure to a specific agent and a health outcome in humans.
- Limited/Suggestive Evidence of No Association. There are several
adequate studies, covering the full range of levels of exposure that
humans are known to encounter, that are mutually consistent in not
showing a positive association between exposure to a specific agent and
a health outcome at any level of exposure. A conclusion of no
association is inevitably limited to the conditions, levels of
exposure, and length of observation covered by the available studies.
In addition, the possibility of a very small elevation in risk at the
levels of exposure studied can never be excluded.
These five categories cover different degrees or levels of
association, with the highest level being sufficient evidence of a
causal relationship between exposure to a specific agent and a health
outcome. The criteria for each category incorporate key points
discussed earlier in this chapter. A recurring theme is that an
association is more likely to be valid if it is possible to reduce or
eliminate common sources of error in making inferences: chance, bias,
and confounding. Accordingly, the criteria for each category express
varying degrees of confidence based upon the extent to which it has
been possible to exclude these sources of error. To infer a causal
relationship from a body of evidence, the committee relied on long-
standing criteria for assessing causation in epidemiology (Hill, 1971;
Evans, 1976).
COMMENTS ON INCREASED RISK OF ADVERSE HEALTH OUTCOMES AMONG GULF WAR
VETERANS
As discussed in the beginning of this chapter, the committee
reviewed the available scientific evidence in the peer-reviewed
literature in order to draw conclusions about associations between the
agents of interest and adverse health effects in all populations. The
committee placed its conclusions in categories that reflect the
strength of the evidence for an association between exposure to the
agent and health outcomes. The committee could not measure the
likelihood that Gulf War veterans' health problems are associated with
or caused by these agents. To address this issue, the committee would
need to compare the rates of health effects in Gulf War veterans
exposed to the putative agents with the rates of those who were not
exposed, which would require information about the agents to which
individual veterans were exposed and their doses. However, as discussed
throughout this report, there is a paucity of data regarding the actual
agents and doses to which individual Gulf War veterans were exposed.
Further, to answer questions about increased risk of illnesses in Gulf
War veterans, it would also be important to know the degree to which
any other differences be-
Veterans and Agent Orange: Update 1996, p. 97 [emphasis added]
Summary Of The Evidence
Categories of Association
The categories of association used by the committee were those used
in VAO. Consistent with the charge to the Secretary of Veterans Affairs
in P.L. 102-4, the distinctions between the categories are based on
``statistical association,'' not on causality. Thus, standard criteria
used in epidemiology for assessing causality (Hill, 1971) do not
strictly apply. The distinctions between the categories reflect the
committee's judgment that a statistical association would be found in a
large, well-designed epidemiologic study of the outcome in question in
which exposure to herbicides or dioxin was sufficiently high, well-
characterized, and appropriately measured. The categories of
association are:
- 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 with
reasonable confidence. For example, if several small studies that are
free from bias and confounding show an association that is consistent
in magnitude and direction, there may be sufficient evidence for an
association.
- Limited/Suggestive Evidence of an Association Evidence is
suggestive of an association between herbicides and the outcome but is
limited because chance, bias, and confounding could not be ruled out
with confidence. For example, at least one high-quality study shows a
positive association but the results of other studies are inconsistent.
- Inadequate/Insufficient Evidence to Determine Whether an
Association Exists The available studies are of insufficient quality,
consistency, or statistical power to permit a conclusion regarding the
presence or absence of an association. For example, studies fail to
control for confounding, have inadequate exposure assessment, or fail
to address latency.
- Limited/Suggestive Evidence of No Association There are several
adequate studies, cover the full range of levels of exposure that human
beings are known to encounter, that are mutually consistent in not
showing a positive association between exposure to herbicides and the
outcome at any level of exposure. A conclusion of ``no association'' is
inevitably limited to the conditions, level of exposure, and length of
observation covered by the available studies. In addition, the
possibility of a very small elevation in risk at the levels of exposure
studied can never be excluded.
Gulf War and Health, Vol. 1, p. 72 [emphasis added]
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
(OTA, 1990).
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
(see below).
Human Studies
Epidemiologic Studies
Epidemiology concerns itself with the relationship of various
factors and conditions that determine the frequency and distribution of
an infectious process, a disease, or a physiological state in human
populations (Lilienfeld, 1978). Its focus on populations distinguishes
it from other medical disciplines. Epidemiologic studies characterize
the relationship between the agent, the environment, and the host and
are useful for generating and testing hypotheses with respect to the
association between exposure to an agent and health or disease. The
following section describes the major types of epidemiologic studies
considered by the committee.
[GRAPHIC] [TIFF OMITTED] T5103.001
Updated Literature Review of Sarin (2004), p. 20 [emphasis added]
OP insecticide data in its conclusion, the committee reviewed the
OP epidemiology literature. The committee responsible for GW2 (IOM,
2003a) reviewed the literature on OP compounds. The present committee
reviewed relevant epidemiology studies published since the preparation
of that report.
Animal studies had a small role in the committee's assessment of
association between putative agents and health outcomes. As with
previous committees, this committee used animal data for making
assessments of biologic plausibility in support of the epidemiologic
data 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.
The committee classified the evidence of an association between
exposure to sarin and cyclosarin and a specific health outcome into
five categories (Box 1-1). The categories closely resemble those used
by previous committees that evaluated the effects of chemicals related
to the Gulf War (IOM, 2000a, 2003a) and those used by several IOM
committees that have evaluated vaccine safety (IOM, 1991, 1994a),
herbicides used in Vietnam (IOM, 1994b, 1996, 1999, 2001, 2003b), and
indoor pollutants related to asthma (IOM, 2000b). The committee's
conclusions, presented in Chapter 4, represent its collective judgment.
The committee endeavored to express its judgment as clearly and
precisely as the available data allowed, and it used the established
categories of association from previous IOM studies because they have
gained wide acceptance over more
BOX 1-1u Categories of Evidence
Sufficient Evidence of a Causal Relationship
Evidence from available studies is sufficient to conclude that a
causal relationship exists between exposure to a specific agent and a
specific health outcome in humans, and the evidence is supported by
experimental data. The evidence fulfills the guidelines for sufficient
evidence of an association (below) and satisfies several of the
guidelines used to assess causality: strength of association, dose-
response relationship, consistency of association, biologic
plausibility, and a temporal relationship.
Sufficient Evidence of an Association
Evidence from available studies is sufficient to conclude that
there is a positive association. A consistent positive association has
been observed between exposure to a specific agent and a specific
health outcome in human studies in which chance1 and bias, including
confounding, could be ruled out with reasonable confidence. For
example, several high-quality studies report consistent positive
associations, and the studies are sufficiently free of bias, including
adequate control for confounding.
[GRAPHIC] [TIFF OMITTED] T5103.002
[GRAPHIC] [TIFF OMITTED] T5103.003
[GRAPHIC] [TIFF OMITTED] T5103.004
[GRAPHIC] [TIFF OMITTED] T5103.005
[GRAPHIC] [TIFF OMITTED] T5103.006
[GRAPHIC] [TIFF OMITTED] T5103.007
Appendix B
Letter to IOM President Regarding Imbalanced Membership of 2016 Report
Committee
November 28, 2014
Dr. Victor J. Dzau, M.D.
President
Institute of Medicine
500 Fifth St., NW ?
Washington, DC 20001
Dear Dr. Dzau,
As former members of the VA Research Advisory Committee on Gulf War
Veterans Illnesses, we are gravely concerned by the makeup of the
committee that IOM staff has chosen for the upcoming review of Gulf War
health literature. The membership is grossly imbalanced toward the
1990's government position that Gulf War veterans have no special
health problem - just what happens after every war, related to
psychiatric issues, and not environmental exposures.
Reviving this discredited fiction will cause veterans' doctors to
prescribe inappropriate psychiatric medications, and will misdirect
research to find effective treatments down blind alleys - an
unconscionable breach of the duty owed to veterans and expected of the
Institute of Medicine.
Science has conclusively demonstrated that this government position
has no scientific validity. Just four years ago, an IOM committee
chaired by Dr. Stephen Hauser, former president of the American
Neurological Association, reviewed the scientific literature and
concluded that the chronic multisymptom illness suffered by an
estimated 250,000 Gulf War veterans (over one-third of the 697,000 who
deployed) is a physical illness associated with Gulf War service, a
``diagnostic entity'' that ``cannot be reliably ascribed to any known
psychiatric disorder,'' and that ``it is likely that Gulf War illness
results from an interplay of genetic and environmental factors.''
http://books.nap.edu/openbook.php?record--id=12835, pages 262, 210,
204, 109, 261
These conclusions reinforced the similar findings and
recommendations of our former committee's 452-page 2008 report. Our
committee went further to identify the specific environmental exposures
responsible, including pesticides, pyridostigmine bromide pills given
to troops as a prophylaxis against nerve gas, and possibly low level
nerve gas released by the destruction of Iraqi facilities, oil well
fires, and multiple vaccinations. In April 2014, our committee
published an update report which concluded that ``[s]cientific research
published since . 2008 . supports and further substantiates the
conclusions of the 2008 report.'' http://www.va.gov/RAC-GWVI/
RACReport2014Final.pdf, page 5
Yet, as the attached analysis shows, fully half the individuals
selected for the new committee are predisposed toward the discredited
1990's government position, either because they promoted it themselves,
or because they are professionally oriented to view such problems as
psychiatric and/or unrelated to environmental exposures. The rest of
the committee are neutral figures with a background in other
neurological conditions like Alzheimer's disease and traumatic brain
injuries. No member of the committee has been actively engaged in Gulf
War health research in the past decade.
Given that the committee is charged with producing a consensus
report, it is wholly foreseeable that its conclusions will end up
between the group predisposed to 1990's fictions and those who are
neutral but unfamiliar with the subject. Compared to the 2010 IOM
report, it will be a reversal toward the discredited 1990's position.
For three years, VA has been engaged in a surreptitious campaign to
revive the 1990's government position. Since no scientific support for
the position exists, VA staff has resorted to manipulating Gulf War
research and reports. The Research Advisory Committee has documented
this manipulation in forty-six pages of findings and recommendations in
June 2012 and in a draft section of its April 2014 report which had to
be removed because VA eliminated the committee's oversight authority.
http://www.va.gov/RAC-GWVI/docs/Committee--Documents/
CommitteeDocJune2012.pdf https://veterans.house.gov/sites/
republicans.veterans.house.gov/files/Binns%2C%20ExhibitBtestimony.pdf
In September, VA's Director of Epidemiology, Dr. Robert Bossarte,
and his staff presented findings of two new VA studies to the Research
Advisory Committee. One showed that diagnoses given to Gulf War
veterans in VA hospitals over a ten-year period were no different than
those given to veterans of the same era who did not deploy. The other,
a large survey, showed that rates of PTSD and depression were
dramatically higher than previously reported by Gulf War veterans.
To an inexperienced observer, it might seem that the research on
Gulf War veterans' health was changing. However, Research Advisory
Committee members quickly pointed out that Dr. Bossarte and his staff
were not telling the whole story. http://www.va.gov/RAC-GWVI/RAC--
Recommendation092314.pdf
The diagnoses study presentation failed to mention that VA had no
diagnostic code for Gulf War illness or chronic multisymptom illness,
that VA doctors at this time were trained to consider the illness as
psychosomatic, and that veterans who served during the period of
greatest toxic exposures were inexplicably excluded from the study.
Similarly, the survey presentation did not disclose that the survey was
overweighted with mental health questions to the extent that the
Committee had repeatedly recommended against sending it out, http://
www.va.gov/RAC-GWVI/docs/Committee--Documents/CommitteeDocJune2012.pdf,
Appendix F, and that the survey's principal investigator had testified
to Congress that his superiors lied to then-VA Chief of Staff John
Gingrich to induce him to release the survey. https://
veterans.house.gov/witness-testimony/dr-steven-s-coughlin The
presentation did not mention that people suffering from chronic health
problems often become depressed after 23 years, but it is not the cause
of their illness.
Dr. Bossarte and his staff will be presenting to the new IOM
committee on December 3. Very likely they will be presenting their new
research findings. But no one on the IOM committee will know that they
are not being told the whole story, because there are no members with
the necessary background. Thus, misleading VA studies will be presented
to an imbalanced IOM committee, which will include the findings in its
new report, and science will be ``revised''.
The motivation behind VA's manipulation of science is clear: to
hold down benefits costs and claims wait times. In April, Military
Times reported that VA Undersecretary for Benefits Allison Hickey was
concerned that even using the term ``Gulf War illness'' ``might imply a
causal link between service in the Gulf and poor health which could
necessitate legislation for disability compensation for veterans who
served in the Gulf.'' http://archive.militarytimes.com/article/
20140422/BENEFITS04/304220036/Top-VA-official-questions-use-term-Gulf-
War-illness-
She also recently testified to Congress that VA would meet its 2015
claims processing target of 125 days unless she had to add a quarter
million new claims to her inventory overnight, as happened in 2010 when
Agent Orange coverage was expanded: ``That will kill us.'' http://
www.veterans.senate.gov/hearings/va-claims-system-review-of-vas-
transformation-progress [1:38:50 mark]
While VA says that it provides care and benefits to veterans
suffering from Gulf War illness under the category ``undiagnosed
illnesses,'' http://www.publichealth.va.gov/exposures/gulfwar/
medically-unexplained-illness.asp, the reality is otherwise. A 2014 VA
report to Congress revealed that only 11,216 Gulf War-related claims
have been approved, while 80 percent are denied. http://www.scribd.com/
doc/241661207/Binns-Parting-Thoughts-093014, page 7. VA's September
2014 press release that ``nearly 800,000 Gulf War era Veterans are
receiving compensation benefits for service-connected issues'' is
grossly misleading. http://www.91outcomes.com/2014/09/va-press-release-
va-secretary-mcdonald.html VA counts every veteran in the area from
1990 to the present as ``Gulf War era,'' not just those who served in
1990-91.
We are appalled that the government has been able to influence the
workings of the Institute of Medicine, the most revered institution in
American medical science, to further its shameful campaign to
manipulate science to deny veterans care and benefits. Regrettably,
however, we are not surprised, as this has been more common than not
where Gulf War veterans' health has been concerned. For example:
1. For fourteen years, in response to a law passed by Congress in
1998, VA has ordered and the IOM has prepared reports on the health
effects of thirty-three toxic substances to which Gulf War veterans
were exposed. The law repeatedly specified that the reports must
consider studies in both humans and in animals. For fourteen years,
however, these IOM reports have considered only human studies. To do
this, VA and the IOM not only have had to disregard the law; they also
had to manipulate the standard established in the IOM reports on Agent
Orange, inserting the word ``human'' in the standard. As a result,
since most research studies of toxic substances are necessarily done in
animals, these IOM Gulf War reports have never found sufficient
evidence of an association between these substances and Gulf War
veterans' health problems. In turn, VA has never recognized any toxic
exposure as a reason for granting these ill veterans care and benefits.
https://veterans.house.gov/witness-testimony/james-h-binns-0
2. The most egregious of these IOM Gulf War reports was the Updated
Literature Review of Sarin, in which animal studies were not considered
even though new animal studies were the only reason that then-Secretary
Principi ordered the report. The outcome of the report was
predetermined before the VA-IOM contract was ever signed, by
understandings between VA and IOM staff discussed in a cover letter
from the then executive director of the IOM to the then head of the VA
Environmental Agents Service. https://veterans.house.gov/witness-
testimony/james-h-binns-0
3. The Research Advisory Committee recommended in 2008 that these
IOM reports be redone in accordance with the law. http://www.va.gov/
RAC-GWVI/docs/Committee--Documents/GWIandHealthofGWVeterans--RAC-
GWVIReport--2008.pdf, pages 53-55, 57. However, they have not been
redone. Worse, the manipulated standard is now being employed in VA-
ordered IOM studies of the health of post-9/11 veterans. The 2011 IOM
report on the long-term health effects of burn pits used to incinerate
waste in Iraq and Afghanistan used the manipulated Gulf War standard
(limited to human studies), not the Agent Orange standard. As a
consequence, the IOM burn pits committee found ``inadequate/
insufficient evidence of an association between exposure to combustion
products and cancer, respiratory disease, circulatory disease,
neurologic disease, and adverse reproductive and developmental
outcomes.'' http://books.nap.edu/openbook.php?record--id=13209&page=6
4. In 2006, the IOM did a general Gulf War literature review for
VA, similar to the current task. Most of the report was a
straightforward summary of the research, but IOM's press release and
press conference focused on one conclusion that echoed the familiar
government theme that there is ``no unique Gulf War syndrome.''
Technically, this only means that others have similar symptoms, but the
press release and conference spun the message to imply that Gulf War
veterans have no major health problem. http://www.nbcnews.com/id/
14801666/ns/health-health--care/t/study-gulf-war-syndrome-doesnt-exist/
#.VHLDjUuBNH8
5. The 2013 IOM treatments report was a recent glaring example of
VA and IOM collaboration to disregard the law and promote the 1990's
government position. A 2010 law required VA to contract with the IOM
for a comprehensive review of the best treatments for ill Gulf War
veterans by a group of doctors experienced in treating Gulf War
veterans ``diagnosed with chronic multisymptom illness or another
health condition related to chemical and environmental exposures that
may have occurred during [their] service.''
Instead, VA contracted for a literature review of treatments for
all ``populations with a similar constellation of symptoms,'' and the
IOM appointed a committee with no experience in treating Gulf War
veterans but extensive experience in psychiatric and psychosomatic
medicine--though the 2010 IOM report had just concluded that the
illness ``cannot be ascribed to any known psychiatric disorder.''
Analysishttps://veterans.house.gov/sites/
republicans.veterans.house.gov/files/Binns%2C%20ExhibitBtestimony.pdf
http://www.scribd.com/doc/150949964/WHITE-PAPER-IOM-CMI-Panel-
Membership-
The individuals selected to give background briefings to the
committee were largely familiar advocates for the 1990's position, who
told the committee the problem was psychiatric. http://www.va.gov/RAC-
GWVI/docs/Committee--Documents/CommitteeDocJune2012.pdf, pages 24-30.
Half the illnesses whose therapies were reviewed were psychiatric. The
report revived 1990's themes that that ``[t]hroughout modern history,
many soldiers returning from combat have experienced postcombat
illnesses. . . that cannot now be attributed to any diagnosable
pathophysiologic entity or disease,'' and that ``[c]linicians should
approach [chronic multisymptom illness] with `a person-centered model
of care . . . that helps patients understand that the word
psychosomatic is not pejorative.''' https://veterans.house.gov/sites/
republicans.veterans.house.gov/files/Binns%2C%20ExhibitBtestimony.pdf
6. The person who identified the individuals to be invited to brief
the treatment committee was the chief scientist of the VA Office of
Public Health, according to Congressional testimony by a senior VA
epidemiologist who worked for him. https://veterans.house.gov/witness-
testimony/dr-steven-s-coughlin
7. One of the psychiatric-oriented briefers was a member of the IOM
Board on the Health of Select Populations, the IOM board that oversees
veterans' studies. Dr. Kurt Kroenke, an Army doctor and psychiatric-
oriented Gulf War researcher in the 1990's, is a leading figure in
somatic medicine. He co-chaired the ``Conceptual Issues in Somatoform
and Similar Disorders'' project that laid the groundwork for the
controversial expansion of the definition of somatoform disorders in
the recently revised Diagnostic and Statistical Manual of Mental
Disorders (DSM-5) of the American Psychiatric Association. http://
www.ncbi.nlm.nih.gov/pubmed/17600162 http://dxrevisionwatch.com/dsm-5-
drafts/dsm-5-ssd-work-group/ He has co-authored publications with two
members of the IOM treatment committee and two members of the new IOM
committee that begins work December 3.
8. Two other members of the IOM Board of the Health of Select
Populations were also leading proponents of the government position on
Gulf War health in the 1990's. Dr. Francis Murphy held the position
equivalent to chief scientist in VA's Office of Public Health, and Dr.
Greg Gray was a Navy doctor who published numerous papers in 1996-2001
that dismissed the idea that Gulf War veterans have any special health
problems. Conversely, as of June 2013, no one on the IOM Board of the
Health of Select Populations represented current scientific
understanding of Gulf War illness. http://www.scribd.com/doc/150949964/
WHITE-PAPER-IOM-CMI-Panel-Membership-Analysis. It is currently
undisclosed who serves on this board, as its membership has been
removed from the IOM website, although the membership of all other IOM
boards continues to be listed. http://www.iom.edu/About-IOM/Leadership-
Staff/Boards.aspx
In summary, there has been a long-term corrupt relationship between
the government and the Institute of Medicine to deny the true state of
Gulf War veterans' health, of which the makeup of the new committee is
only the latest example.
We are confident that neither you nor VA Secretary McDonald, as
newcomers to Washington and to your respective institutions, is aware
of this problem. At one point, none of us would have believed it
possible either. But it is a cancer that threatens to destroy the
integrity and reputations of both organizations. And it makes a mockery
of the mission of the IOM ``to provide unbiased and authoritative
advice to decision makers and the public.'' http://www.iom.edu/About-
IOM.aspx
We urge you to conduct a thorough investigation of this problem and
to fix it. The most effective and rapid approach is for the IOM to
handle this itself. If it does not, however, we will work with
veterans' organizations to show Congress the need to conduct an
investigation and enact legislative solutions.
As part of putting IOM on solid ground going forward, we urge you
to replace the eight provisional members predisposed to the
government's scientifically discredited 1990's position with
individuals representing current scientific knowledge of Gulf War
research and the health effects of neurotoxic exposures. We also urge
you to replace those members of the Board on the Health of Select
Populations identified with this position, with individuals
representing current scientific knowledge regarding veterans' health
and environmental exposures.
Respectfully,
James Binns
Former Chairman, Research Advisory Committee on Gulf War Veterans
Illnesses
Beatrice A. Golomb, MD, PhD
Professor of Medicine, University of California San Diego
Current Member, Research Advisory Committee; former Committee
Scientific Director
Rev. Joel C. Graves, DMin,
CPT U.S. Army (Ret.)
Former Member, Research Advisory Committee
Marguerite L. Knox, MN, ARNP-FNP/ACNP
COL, South Carolina Army National Guard
Former Member, Research Advisory Committee
William J. Meggs, MD, PhD
Professor and Chief, Division of Toxicology, Brody School of
Medicine, East Carolina University
Former Member, Research Advisory Committee
cc: Institute of Medicine Council
Analysis of the Provisional Committee Membership
November, 2014
The provisional committee is grossly imbalanced in favor of the
1990's government position that Gulf War veterans have no special
health problem-just what happens after every war, related to
psychiatric issues, and not environmental exposures.
The following committee members are predisposed toward this
position, either because they personally supported it, or because they
are professionally oriented to view these kinds of health problems as
psychiatric and unrelated to environmental exposures.
Dr. Kenneth Kizer, as VA Undersecretary for Health, 1994-1999, was
the chief promulgator of this position, including this 1997
Congressional testimony: ``The overall frequency of unexplained
symptoms among Gulf War veterans appears to be about the same as in a
general medical practice.'' http://www.va.gov/OCA/testimony/hvac/sh/
hvac61.asp
Dr. Howard Kipen, a member of the VA Persian Gulf Expert Scientific
Committee, 1993-1997, has published ``Military deployment to the Gulf
War as a risk factor for psychiatric illness among U.S. troops'' (2005)
http://bjp.rcpsych.org/content/188/5/453.long and that ``[c]oncerns . .
. of a unique Gulf War syndrome, remind us that military personnel
returning from wars have regularly described disabling symptoms'' (co-
authored with Dr. Kroenke). Unexplained Symptoms after Terrorism and
War: An Expert Consensus Statement. Journal of Occupational and
Environmental Medicine 45(10):1040-8, 2003
Dr. Herman Gibb runs a private consulting firm. The NIH reportedly
terminated its contract with his previous firm, while he was president,
on grounds that his firm was working for three chemical companies at
the same time it was reviewing their chemicals for the government.
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/13/
AR2007041301979.html
Dr. Nancy Woods is an expert on midlife and aging women's health;
her background relevant to Gulf War illness was as a member of the IOM
committee that authored a 1996 report, ``The Health Consequences of
Service During the Persian Gulf War,'' which concluded: ``Men and women
served side by side in conditions that increased the stresses of
serving in these grim surroundings . . . Studies of Gulf War veterans
suggest that these veterans suffer from a variety of recognized
diseases, . . . not the existence of a new disease. `` http://
books.nap.edu/openbook.php?record--id=5272&page=R6
Dr. Javier Escobar is a professor of psychiatry at the Robert Wood
Johnson Medical School, where his work ``focuses on the somatic
presentations of psychiatric disorders in primary care . . . as
director of the `Medically Unexplained Physical Symptoms Research
Center.''' http://www.physicianfacultyscholars.org/nac/escobar.html
With Dr. Kroenke he was a member of the ``Conceptual Issues in
Somatoform and Similar Disorders'' project that laid the groundwork for
the controversial expansion of the definition of somatoform disorders
in the recently revised Diagnostic and Statistical Manual of Mental
Disorders (DSM-5) of the American Psychiatric Association, and was a
member of the task force that wrote DSM-5. http://www.ncbi.nlm.nih.gov/
pubmed/17600162 http://dxrevisionwatch.com/dsm-5-drafts/dsm-5-ssd-work-
group/ http://www.dsm5.org/MeetUs/Pages/TaskForceMembers.aspx He was a
member of the 2013 IOM treatment report committee.
Dr. Scott Fishman is board certified in psychiatry and pain
medicine. His research includes a focus on ``psychiatric issues of
chronic illness and pain.'' http://www.ucdmc.ucdavis.edu/publish/
facultybio/search/faculty/508
Dr. Alberto Caban-Martinez studies musculoskeletal pain in workers
related to their occupational risk factors. http://
www.cabanmartinezlab.com/#!about/c46c He has studied ``The prevalence
of Somatic Disfunctions in a Multi-Center Outpatient Osteopathic
Medicine Clinic'' http://nhsn.med.miami.edu/documents/cv/a--
cabanmartinez--cv--09.pdf and has published that ``[c]onstruction
workers struggle with a high prevalence of mental distress, and this is
associated with their pain and injuries.'' J Occup Environ Med 2013
Oct;55(10):1197-204
Dr. Deborah Cory-Slecta, the committee chair, has not done Gulf War
health research herself but stated in 2013, in connection with service
on another IOM Gulf War committee, that she does not believe Gulf War
illness research has produced adequate data to show what caused the
illness. http://www.forbes.com/sites/rebeccaruiz/2014/03/12/experts-
cant-decide-on-definition-for-gulf-war-illness/ She also served on the
2003 IOM Gulf War committee that concluded there was insufficient
evidence to show an association between any illness affecting Gulf War
veterans and exposure to pesticides, applying the manipulated standard
that excluded animal studies. http://www.nap.edu/openbook.php?record--
id=10628&page=R5
The other half of the committee are neutral, people who have not
been engaged in Gulf War health research themselves, but who have a
background in studying other neurological conditions and expertise in
relevant subjects like neuroimaging, neuropsychology, and
neuroepidemiology. They include Dr. Robert Brown, Dr. Ellen Eisen, Dr.
Mary Fox, Dr. Clifford Jack, Dr. Joel Kramer, Dr. Francine Laden, Dr.
James Noble, and Dr. Anbesaw Selassie.
Conspicuously absent from the committee are any doctors or
scientists who have studied Gulf War health in the past decade, who
have studied or treated other groups subjected to neurotoxic exposures
like farmers or pesticide applicators, or who have studied the effects
of Gulf War exposures in animals.
MONTRA DENISE NICHOLS
Submitted by Montra Denise Nichols, MAJ USAFR(RET), RN(ret), MSN
Vice Chair of National Vietnam and Gulf War Veterans Coalition
Good afternoon Committee members and Veterans. I am Montra Denise
Nichols,Maj, Retired USAF NURSE, Gulf War veteran and Vice Chairman of
National Vietnam and Gulf War Veterans Coalition. I am also one of the
ill gulf war veterans. I have attended all but two of the VA RAC GWIR
meetings except for 2, attended all the VA advisory committee meetings
on Gulf War Health and Benefits, have attended in person or by phone
the IOM NAS public meetings on GWI, served on the first DOD-CDMRP Peer
review process at DOD CDMRP, PAC meetings, PSOB meeting, town hall
meetings by OSIGWI meetings, CDC meeting in 1999, hearings on the hill
and have testified in person or by written submission since 1994, and
in addition have attended medical conferences that have direct
connections to our illnesses. I have also participated in 8 research
projects as a research subject for 6 researchers on gulf war illness.
Ialso was listed as a coauthor on the Hypercoagulation peer reviewed
paper published in 2000.
Over the last 22 years since our return home from Operation Desert
Storm we have continued to advocate for all gulf war veterans that are
ill. It has been a long trudge through this mass of activity and now
our journey that seems to have a perpetual loop between VA , Institute
of Medicine reports from the National Academy of Science, hearings here
on the hill on an irregular basis, and the VA RAC GWIR. It is
disappointing to say the least that the situation never seems to get on
the Right Path to unify and address the real physical damage that
veterans of Operation Desert Storm encountered after toxic exposures.
The VA RAC GWIR and the DOD CDMRP has been the leaders in this effort
to get answers thru real medical research to find the right diagnostic
tests, biomarkers and finally real treatment options that are not
palliative. The VA seems to be the road block over and over. The
veterans of the gulf war are suffering because of the Actions of the VA
or shall I say the INACTION. I have witnessed first hand how the VA RAC
GWIR Advisory committee has labored since 2002 and have seen the
intransigent activity of the VA. This is occurring at the top and seen
clearly at the bottom re the clinical care of the gulf war veterans or
the lack thereof and there is a problem that has not been solved for 22
years. I left the VA angry when my female hematologist primary care
told me her hands were tied, and she even got tears in her eyes. I left
because I both in the information on the hypercoagulation problem that
I feel as a nurse can relate to early needless deaths of gulf war
veterans who are ill. I had my own test results and she would not call
the Drs and researchers that had done this study independently. They
were concerned about my own elevated values and had suggested treatment
that she refused to consider. What really made me madder was when I
found out the editor of that journal that published our peer review
research was the head of the VA lab at the Denver VA the one I was
going to for care. That was in 2000. Since then I have tried to go back
to the VA and told during 2003-4 time period it would take 6 months to
a year to get an appointment. I continued as many of us have to
suffered and seek care when I could. I was lucky to have health care
insurance through my husband but I lived in fear of loosing it if they
the doctors deemed it war related. I certainy did not want to risk the
insurance we had for my husband and my child. I struggle finding
doctors that want to delve into this because they also do not have the
knowledge on toxic exposure effects and they are hesitant to get
involved when their might be government forces at work. I know the
doctors that have suffered retaliation from the VA for trying to help,
I know some of the researchers that are hesitant also because of that
same potential, and we even had a county corner fired when she ruled a
death of a veteran due to gulf war exposures. I have had a benefactor
that helped several veterans get care through environmental medicine
doctors, and I return to them when I can afford to travel and pay out
of pocket for their fees and tests. I know of other civilian doctors I
would like to get to but again it involves travel and cost factors. I
was recruited for research at WRIIS at DC and received good research
testing and caring doctors but yet they did not put me through the 2
day WRIIS protocol. I have said I will pay for my travel but I want to
get thru that evaluation, I am being denied that until I can get back
into the VA medical appointment system in Denver and get a doctor to
refer me to WRIIS. And since what I got was research those test have
not been entered in my record, I was told yes I failed the testing
which to me was no big surprise. But it doesn't help with getting
further care or a claim that is service connected.
I have participated in research projects and even recruited others
to participate and know the researchers are finding clues and when
their papers are published -those results will help hopefully to better
diagnosis and treatment potentials. But when doctors are not being
educated on those findings then the interface with research and care is
failing.
We the veterans see the continued battles that have occurred thru
the years. It is a shame and a disgrace that the VA has not taken the
advice of the RAC GWIR. That interference has stymied for years the
beneficial work of scientific researchers, doctors, and researchers. It
has blocked actively the improvements that could of have been made over
the last 22 years in the actual clinical care that could have made a
difference in the quality of care, diagnostic abilities, and yes real
treatment. And yes they could have saved countless lives of gulf war
veterans that have died in an early age group under the age of 50!
I was one of roughly 20 fellow veterans that took part in the
public meetings of the last IOM/NAS report. Each offered public comment
and offered the IOM committee real insight into our situation. ALL of
us were in anguish listening to their first public meeting that
concentrated on the psychology-stress aspect yet again! After
listening, then offering public comment, and debriefing with my fellow
ill veterans and spouses that were on line, I immediately called the
chairman of the VA RAC GWIR, Mr. Binns. I wanted to give him our
feedback, what had been covered, and our very deep concerns that this
marked yet again a back tracking effort on the part of the VA that
institutes the charter and guidance when they contract a literature
review from the IOM/NAS. It was like all the work that had been done on
gulf war illness research had not even been considered.
Our input seemed to not even be heard. These committee members I
wonder if they have ever seen and cared for even 100 of the gulf war
vets with the multitude of health issues. After 22 years and excellent
research from outstanding doctors and researchers that had proven that
physical damage has occurred to hundreds of thousands of veterans it
appeared we were back to step one all over again. The IOM/NAS never
ever in their hearings heard presentations from the doctors and
researchers that have studied us or group of gulf war veterans to be
able to comprehend their findings. This is wrong.
Their definition the IOM committee used is so broad that it creates
confusion yet again. Patients that have had chemotherapy could easily
fit the definition and have had no military exposures much less other
categories of patients. This definition does not even have relevance to
the definitions already being used for the RAC GWIR reports of 04-thru
current year. They did not even utilize guidance that the DOD CDMRP
process has used since 2006 in peer review and awarding of gulf war
illness research. Their definition truly creates havoc in the work that
has been developed by researchers over the past 10 years. The IOM NAS
committee did not hear from the range of researchers that have been
involved thru the years examples include UTSW Medical , Wright State,
University of Miami, to name just a few.
Again and again the VA and IOM/NAS work seems to set us further
behind in the goals to get better diagnostic testing of gulf war
veterans who have suffered for 22 yrs. The goal of getting true
treatment gets pushed back yet again. Right now we basically have
COQ10(that the VA hospitals will not provide) and CPAP (used in sleep
apnea) as real physical treatment. I put acupuncture and cognitive
behavior techniques as supportive palliative treatment. As an analogy I
would use a cardiac patient with significant blockages of the cardiac
arteries that need stents/bypass/ medications being ordered to just use
exercise, acupuncture, and stress reduction as their total care. The
situation is dire.
More and more of the results from research are showing significant
damage to the brain and the autonomic nervous system. This should help
make sense of what health care providers are seeing at each VA
hospital. When you have brain and autonomic nervous system and
hypercoagulation of the blood involved it affects every other organ in
the body.
The care of our gulf war veterans is impacted by the VA that still
resists the significance of the damage done to hundreds of thousands of
gulf war veterans. When the doctors and health care providers are not
updated/educated on all the significance findings of this effort in
research it is truly unacceptable. When the veteran patient/client is
even providing hand carried copies of the reports and research papers
to their health care provider at the VA and for those efforts to be
ignored is truly showing some type of mind set to ignore, delay, and
deny. The VA even when they have misspent money on conferences in the
past number of years have not even focused on education for the
clinicians on what is being found in research on gulf war illness and
seeking to institute a true intergradation of research into the
clinical practice of health care providers that are seeing the gulf war
veterans who are ill daily. Legislation is needed.
The clinicians on the whole don't even know of the WRIISC and the
referral method that shows you why most veterans give their health care
provider a D or F in grading. The clinicians could also be asked to
give feedback to the RAC GWIR or headquarters VA Health care on
information and findings they are finding on their gulf war veterans
but that is not done. There is no interface between the VA health care
providers and the Researchers and Doctors that have worked with gulf
war veterans in civilian or VA practice. This needs urgent action at
the highest priority!
It is unconscionable to see that some gulf war veterans have found
civilian doctors and resources that can do testing and help gulf war
veterans but the majority of gulf war veterans cannot pay out of their
pocket to travel and get to these doctors and pay those civilian
doctors. WE know there are places like the Mayo Clinic that can provide
autonomic nervous system testing but 99% cannot get that important
testing. The VA has not had training programs or the equipment in order
to perform this testing. There is now a commercially available test for
the hypercoagulation problem that was first researched and published in
2000, and we have research currently on that area by Dr. Bach at VA
Minneapolis on this topic. Again a critical need that could possibly
save gulf war veterans lives from pulmonary embolism, cardiac
incidents, strokes, deep vein thrombus, and other death potential
diagnoses. Where is the priority to truly help gulf war veterans and
get the diagnostic testing and lifesaving treatment? Legislation is
needed.
Then we have only 3 WRIIS serving as second opinion but there are
hundreds of thousands of gulf war veterans not getting the highest
quality of care that should be available at each VA hospital or at
least one in each VA region. The majority of the veterans asked said
their VA primary care personnel had no knowledge of gulf war related
illnesses and physical problems. The veterans that gave an A or a B
were the ones that had gotten to the WRIIS or had struggled to get a
change of doctor or a referral to a specialist like rheumatology.
(these are still in the low minority , seeing that the WRIIS only see
limited number of gulf war veterans(2 a week)) . When asked to grade
the education of the providers on exposures and effects, gulf war
illness, and care from the VA providers the grades given were
predominately D and F.
Additionally care also involves helping the spouse or loved one
trying to take care of the veteran at home. Unfortunately, although we
served in Iraq as did the current OIF, OEF veterans no provision was
made to cover caregivers for the Operation Desert Storm Veterans of
1990-91. A percentage of our veterans need that help too! The spouses
are suffering and trying to be the bread winners of the family while
caring for their adult veteran spouse that have become housebound to
varying degrees. With the significant neurocognitive, the debilitating
CFIDS, or development of MS, Cancers, or other devastating illnesses in
a group of younger veterans below the age of 50 there needs to be
consideration to including the spouses from 1990-91 who may still have
young children school age at home( and some of these have developmental
type problems.) The door to caregiver assistance needs to be consider
for these cases including ALS veterans. Legislative effort will be
needed to amend that law.
The need is there for the providers of health care in the VA to
have the gulf war veterans seen by designated trained physicians at
each VA hospital/clinic. WE need our gulf war clinics back that we had
in the nineties. WE need to have support groups at each VA hospital for
gulf war veterans and their spouses with care providers and social
workers. WE need gulf war veteran task forces at each VA or at least at
one VA hospital in the state to have the interaction that is needed to
be heard and improvements made. Legislation will be needed.
WE need an active sharing of data on deaths, age, unit, cause of
death and statistics in comparison to the normal non- military age
groups. This is needed for our researchers and for us the veterans.
This will need legislation.
WE need a robust accounting like we had with GWVIS data that is
produced every three months. The data needs to show diagnoses and ages.
Again researchers and veterans need this information. Legislation will
be needed.
WE need to have you all reconsider registry for the family members
that feel their symptoms are the same as the veterans. WE had that in
the ninties but it was allowed to expire time wise. Again legislation
needed.
WE need the VA to hire consultants in the area of environmental
medicine and integrative medicine to be involved in updating the VA
system in dealing with exposures effects. Again legislation will be
needed.
WE need all data from the DOD declassified. It has been 22yrs and
some of that massive data could possible provide insights into the
potential causes. This may have a direct impact on our health. Again
legislation is needed.
WE need newsletters that are not just PR pieces for the VA but
informative and that includes all research findings and recruitment not
just from VA research but DOD CDMRP research or other civilian research
that might match conditions/diagnoses that the veterans are receiving.
Legislation is needed.
WE need our records clearly identified as Gulf War in theater or
non-deployed and unit assigned to in order to also have data that would
show if particular units are more ill or have a higher death rate.
Legislation will be needed,
Our veterans are actively seeking a means to relocate their fellow
veterans that served in the same unit. There should be a means to help
veterans to find each other to facilitate buddy letters if needed. And
this would also assist our researchers. Legislation is needed.
The other item is to provide fee basis to get the testing that is
commercially available ie hypercoagulation test . The need for
autonomic nervous system testing that the VA cannot provide needs to be
funded not only for those in the VA system but those other gulf war
veterans not being seen at the VA. Specific legislation is needed.
There needs to be another time period extended for gulf war
veterans that missed the initial time period allowed after operation
desert storm or those that got fed up and left the VA and have
struggled to find help in the civilian medical field. Currently I am
living through that and have had a number of veterans communicate with
me this past week of not being allowed in VA if they did not meet the
means test. Much less those with insurance that they paid for being
billed for health effects of service while they continue to try to get
their claims through the system. Legislation is needed.
The VA still wants to label this with a name or diagnosis that does
not even relate to military, war time, or hazardous exposures and that
in itself is viewed as an insult to the veterans! The VA still wants to
push treatment that centers on Psychological and stress, we deserve
better. We started out with many VA gulf war clinics in the nineties
and then they were closed! Legislation is needed.
The gulf war veterans when they try to discuss their exposures and
relationship to their service and effect on changes in their body
systems with their health care provider they are verbally or
nonverbally shut down. We gulf war veterans have guided other veterans
experiencing these problems to ask for change of doctors or provider at
VA and we have provided the education to the veterans about the WRIIS
program and guided them to inform and educate their doctor of the
information on the VA's own website about the WRIIS and how the doctors
are to refer them electronically. Legislation is needed for mandatory
CME education for our health providers seeing ill gulf war veterans.
Legislation is needed.
We have provided the flow of information even the actual research
papers and RAC GWIR reports to our fellow gulf war veterans and
encouraged them to share it with their VA health care providers. We
have done the outreach to the veterans not the VA, we do this as our
continued duty to each other as former military personnel that do care
for each other even when we have not met them in person. WE listen and
read what they are experiencing and their frustrations at getting
sicker and having less quality of life and do our best to try to help
our fellow gulf war veterans even as we are also ill and struggling to
get care that we deserve.
WE have tried but as you see after 22 years we need firm
legislative efforts and laws that will be enforced to make a
difference!
And most of all the VA RAC GWIR needs to be recognized and VA must
be held accountable for their intransience that has led to poor
diagnostic testing, biomarker development, care and potential
breakthroughs for treatment. This must stop. And the cycle ongoing
between VA and IOM NAS must be but under great scrutiny.
WE also need hearings more frequently with the House and Senate VA
committees. I suggest joint hearings to elevate the priority and to
gain unity on the hill on this effort. I also suggest that other gulf
war veterans and a few spouses be allowed to testify to truly give more
insight to our elected representatives of what we are living through.
WE also need an ongoing VA advisory committee on health and benefits
for gulf war veterans in law so it is not a one time 18 month advisory
committee. These issues need just as much attention as the Research.
Legislation similar to the legislation that set up the VA RAC GWIR is
needed. Until the situation is improved we need this effort. WE need
transparency and reports publicly available for any and all Task Force
activities concerning gulf war veterans' illnesses that VA has
conducted! Please legislate and enforce these efforts so direly needed.
Our claims are likewise in poor condition because VSO's and VA rating
officials have not been trained to adequately deal with the claims of
gulf war illnesses. WE need urgent help 22 years is too long to have
waited.
KIMBERLY SULLIVAN, PHD
25 Years after the Gulf War: Gulf War Illness, Brain Cancer and Future
Research
Research Assistant Professor, Department of Environmental Health
Boston University School of Public Health
Former Associate Scientific Director
VA Research Advisory Committee on Gulf War Veterans' Illnesses
On this week marking the 25th anniversary of the Gulf War, I would
like to express my concern and disappointment with the conclusions from
the recent volume 10 Institute of Medicine Gulf War Report and
highlight some of the important research that is ongoing in this field.
Gulf War Illness
GWI is a constellation of chronic health symptoms including
fatigue, pain, headaches, gastrointestinal and cognitive problems. It
is a multi-system disorder meaning that it affects not only the central
nervous system but also the immune and gastrointestinal systems. It
affects about a third of the nearly 700,000 veterans deployed to the
war.
Gulf War Illness as a Functional Disorder
The IOM report goes to great length to describe GWI as a self-
reported symptom based disorder for which there are no current
objective biomarkers and therefore it must be a `functional disorder'
meaning it has no physical cause. The report describes it to be similar
to other well accepted symptom based disorders including post-traumatic
stress disorder (PTSD). In fact, this report places PTSD as the only
disorder that has `sufficient evidence of causal association' to
deployment to the Gulf War while it places GWI in the second category
of `sufficient evidence of an association' to deployment to the Gulf
War.
However, less than 10% of GW veterans have been diagnosed with PTSD
and more than 30% have been diagnosed with GWI. In addition, it is
completely unclear why GWI is not also causally-related to deployment
to the war when both disorders are diagnosed the same way - by self-
report of chronic health symptoms.
The report also stresses that the health conditions associated with
Gulf War deployment are primarily mental health disorders and
functional medical disorders and that these associations emphasize the
interconnectedness of the brain and body.
However, the brain and body are interconnected in GWI not because
this is a stress-related disorder without a unifying pathobiological
cause as the IOM report suggests, but rather because they are all part
of the brain and immune pathways that are activated as part of the
neuroinflammatory response to pesticide and nerve agent exposures.
These chemicals directly target the nervous system and cause
inflammation. These pathways start by activating the immune cells in
the brain called microglia that release chemical messengers called
cytokines in the brain and the many body systems that are affected in
GWI. Activating these inflammatory systems in the brain and throughout
the body can result in chronic symptoms such as joint and muscle pain,
memory problems, fatigue, headaches, and gastrointestinal distress-all
symptoms found in GWI. Researchers call this type of chronic condition
a post-inflammatory brain syndrome.
In fact, a paper by Gulf War researchers from the Centers for
Disease Control (CDC) recently showed that Gulf War-relevant pesticides
and nerve agents produced a neuroinflammatory response resulting in
hundreds-fold higher cytokine chemical signaling in a GWI animal model.
Preliminary studies in veterans with GWI suggest increased cytokine
levels that correlate with GWI symptoms as well.
Treatment focus for Veterans with GWI
The IOM report has concluded that research efforts should be
realigned to focus on the treatment and `management' of Gulf War
illness rather than its causes. However, biological targets focused on
neuroinflammatory markers described above provide tangible and targeted
treatment strategies for GWI. Researchers at Boston University, Nova
Southeastern University and VA medical centers in Boston, Bronx and
Miami are currently assessing the effectiveness of targeted treatment
trials using intranasal insulin, D-cycloserine and Co-enzyme Q10 to
treat the constellation of symptoms in GWI including cognitive, fatigue
and pain symptoms. Clinical researchers can do better for our veterans
than `manage' their symptoms as the IOM suggests and the research
community is hopeful that these currently funded treatments will
provide much needed symptom relief for ill Gulf War veterans.
Brain Cancer Association with Gulf War Service
The IOM report also states that the results of two published VA
studies reporting significantly increased brain cancer mortality rates
found in GW veterans who were in close proximity to the Khamisiyah
weapons depot detonations where large stores of sarin/cyclosarin were
destroyed cannot be trusted because the exposure plume modelling done
to determine who was exposed may be inaccurate. However, inaccuracies
in exposure modeling often make the analysis less sensitive rather than
more sensitive to finding differences between groups. Therefore,
finding a 2 and 3 fold increase in brain cancer deaths in sarin exposed
GW veterans suggests that these rates are likely an underestimate of
effect rather than an overestimate of the effect of sarin exposure on
brain cancer mortality in GW veterans.
Conclusion
The IOM report has downplayed the importance of continuing to
research the remaining questions in GWI including identifying
biomarkers of current illness, prior neutoxicant exposures and targeted
treatment strategies. This work is critically important to Gulf War
veterans who suffer from chronic health effects from these toxicant
exposures but also for many others including those who are
occupationally exposed to pesticides, including farmers and pesticide
applicators around the world. Gulf War veterans are counting on
researchers to identify the cause and pathobiology of their
debilitating illness, and to identify treatments that will work to
improve all of their symptoms, not just manage them.
Most importantly, the end result of this report is that GW veterans
suffering from brain cancer or family members of those who have already
succumbed to brain cancer will not receive VA benefits now or likely
ever for their service-related mortality. These veterans have been
forced to fight for benefits while they are fighting for their lives.
These veterans should be given the benefit of the doubt in providing
them with VA service connection for this service-related mortality.
DAVID K. WINNETT, II
Thank you, Chairman Coffman, Ranking Member Kuster, and Members of
the House Veterans' Affairs Subcommittee on Oversight and
Investigations for today's hearing.
I also wish to thank my fellow brothers- and sisters-in-arms who
have joined this hearing in person, and to those of my fellow Persian
Gulf War veterans who are watching these proceedings from afar. The
testimony I provide to this distinguished Committee is done in honor of
the extraordinary sacrifices that my fellow Gulf War veterans have made
over the course of the past 25 years, first by the historic and heroic
victory achieved during the 1991 Persian Gulf War, and then by the
super human sacrifices made in the years since, both individually and
collectively, in fighting what has turned out to be a much more
formidable foe than the enemy soldiers we once routed on the toxic
battlefields of the Middle East.
BACKGROUND
I am a 20-year veteran of the United States Marine Corps, having
enlisted as a Private in January 1975 and retiring as Captain in 1995.
In total, I wore 11 different ranks as a Marine, from Private (E1)
through Staff Sergeant (E6), Warrant Officer (W1) through Chief Warrant
Officer (W3), then First Lieutenant (earned while deployed to the Gulf)
to Captain.
My service as a Marine was, without exception, the most rewarding
experience of my life. I appear before this honorable body today,
exactly 25 years to the day that I led a Platoon of the most courageous
and capable United States Marines I ever had the honor of serving with
across the line of departure into Kuwait, along with combat elements of
the 1st Marine Division, to liberate that beleaguered country and its
people from the occupying grip of a vicious dictator. As history now
demonstrates, our mission succeeded well beyond what even the most
educated military scholars had predicted earlier.
But sadly, I appear here before this Committee in many respects, a
physically broken man. Not as a result of the normal aging process, not
from the effects of enemy bullets or shrapnel, and certainly not from
the stress of combat operations that occurred 25 years ago, but because
of a physiological demon that managed to find a way to penetrate not
only the substantial layers of protective clothing and equipment that I
wore throughout the ground assault through Kuwait, but into my flesh,
my internal organs, and through the blood-brain barrier that normally
serves to protect the neurological mechanisms that control our
cognitive abilities, our autonomic nervous system, and just about
everything in the brain that regulates normal functioning of the human
body.
In short, I am, and have been a very physically sick man for the
past 20-plus years. But the fact remains, I am here, I am still a
United States Marine, and as far as I'm concerned I remain actively
engaged in combat, as do hundreds of thousands of my fellow Gulf War
veterans. The only thing that has changed over the 25 years that have
passed since our rapid and resounding defeat of the Iraqi Army is that
now we face a different foe, a foe much more resourceful and stubborn
than even the toughest Iraqis that we faced during Operation Desert
Storm. It pains me to admit that the battle we fight today is against
some within the U.S. government - the same government that sent us to
war in the first place.
Over the past few weeks I have read numerous media accounts and
engaged in a number of discussions with my fellow veteran advocates
regarding the recent report issued by the Institute of Medicine (IOM)
entitled, ``Gulf War and Health, Volume 10: Update of Health Effects of
Service in the Gulf War.'' I cannot find words that are of sufficient
power to express the disappointment I feel in the conclusions and
recommendations contained in that report. Given the substantial body of
scientific evidence that over the past decade has proven time and time
again, beyond any doubt whatsoever, that Gulf War Illness is indeed a
genuine physiological illness and that effective physiological
treatments can likely be found, I simply cannot believe that the IOM
made a 180-degree turn away from that science to a position that Gulf
War Illness should now be treated primarily as ``mind-body
interconnectedness'' - as if it were a mental disorder.
In the interests of providing context to my testimony, I would hope
that my military record would serve to support my assertion that when I
say that I am physically sick, that I know my own body, and that my
health conditions are primarily physical and not psychological, that
your Committee would take me at my word. As many of you know, within
the ranks of our military, an officer's word is his or her solemn bond.
And when I say that I am convinced beyond any doubt whatsoever that, as
countless research studies have shown, more than 200,000 of my fellow
Gulf War veterans are as sick or sicker than myself, that your
honorable body will trust me on that count as well.
My military career was, by any measure, a quite successful one. Few
United States Marines are able to wear 11 different ranks over a period
of only 20 years. A four-star General has been promoted nine times,
usually over a span of 30 or more years; I was promoted ten times in 20
years. Three of the five promotions I received as a young enlisted
Marine were earned ``meritoriously''. This is not an easy
accomplishment in the Marine Corps, I assure you. During my assignment
to the Non-Commissioned Officers (NCO) school at Camp Hansen, Okinawa,
I finished second out of a class of 39. As a Sergeant (E5) at the Staff
NCO Academy at El Toro, I finished second out of a class of 59, most of
whom were very seasoned Staff Sergeants (E6) and Gunnery Sergeants
(E7), many of them current or former drill instructors. Three years
following that I was among just 250 of 2,500 applicants Marine Corps-
wide to receive an appointment to the rank of Warrant Officer (W1), and
I completed the Warrant Officer Basic Course in Quantico in the top 10%
of my class. Later, while under orders to the Marine Corps Degree
Completion Program, I completed a Bachelor of Business Degree (BBA)
Magna cum Laude. I worked hard for every single promotion or personal
decoration that I received as a Marine. Not once in 20 years did I ever
fail to achieve a score of First Class on my quarterly Physical Fitness
Tests (PFT). I was a competitive shooter as a young Lance Corporal,
competing in the 1976 Far East Division Matches. I was good at whatever
I set my mind to do.
I've listed these career milestones, not as a means of pounding my
chest, but to convey to your honorable body that in 20 years of service
as a United States Marine, I was never considered a ``quitter'' or a
``sick bay commando''. I was a competitive person then, and that
competitive spirit still lives in me this very day. In fact, were it
not for the fighting spirit I learned as a United States Marine, I
doubt very much that I would be sitting here today. The point I'm
making is this: I am appealing to the honorable members of this
distinguished committee to take this Marine at his word. I am not a
malingerer. I am not a liar. I am not mentally disturbed. My physical
pain is real, and it is severe. The profound fatigue that I live with
day in and day out is not a psychosomatic disorder. More importantly,
the more than 200,000 of my brothers- and sisters-in-arms who live with
the same physical pain and fatigue and other symptoms that I live with
are not imagining their illnesses. This preposterous idea that Gulf War
Illness should be treated primarily with cognitive behavioral therapy,
exercise, and psychiatric drugs as suggested in this new DOD/VA
Clinical Practice Guideline as if it were a psychosomatic condition is
not only ridiculous, it is highly offensive to the warriors whose lives
have been literally destroyed as a result of serving on what was
undoubtedly the most toxic battlefield American forces have served on
in the history of this great country.
Four years ago my worsening physical condition forced me to walk
away from a prestigious position as the Fleet Services Manager for the
City of Torrance, California, where I managed a $12 million dollar
budget, 36 employees, and a fleet of over 700 vehicles, and had a
salary of over $120,000 per year, not counting benefits. Does anyone
believe that a rational individual would walk away from such a
lucrative career in order to obtain an annual veteran's disability
payment of $36,000 per year?
I have been a very vocal advocate for veterans suffering from Gulf
War Illness since 2008. I've written a number of op-eds for various
news publications around the country, participated in radio and
television interviews about Gulf War Illness, and shared quite a few
poems written to honor the sacrifices of my fellow veterans. I have
been actively involved with the Congressionally Directed Medical
Research Program (CDMRP) for Gulf War Illness treatment research for
the past six years as a consumer reviewer at both tiers of the review
process, first as a member of the Scientific Merit Review panels, and
currently as a member of the Programmatic Panel. I believe very
strongly in the unparalleled work of this treatment development
program.
ONLINE GULF WAR ILLNESSES DISCUSSION GROUP
In 2009, I created one of the first Facebook pages focused on Gulf
War Illness. It is a ``closed'' group that goes by the name of ``Gulf
War Illnesses''. Today this discussion group has an active membership
of nearly 10,000 veterans, family members, and a few others interested
in helping with our cause. As the sole administrator for the group, I
personally screen each applicant who wishes to join to ensure it
remains focused on our core mission - providing a private forum where
ill Gulf War veterans feel free to share sensitive information about
their battles with Gulf War Illness and other life challenges that
often go hand in hand with chronic illness.
Members of the Gulf War Illnesses group also post frequent updates
regarding ongoing Gulf War Illness research and news articles that are
relevant to our cause. We have a number of very experienced individuals
who offer free VA claims advice to other members. But most importantly,
we provide a forum where veterans suffering from the debilitating
symptoms of Gulf War Illness can find a sense of empathy, camaraderie,
and mutual support any time of the day or night.
SUICIDES. Sadly, and more frequently than I would have expected, we
sometimes lose members to suicide. Our group is fiercely loyal and
protective of one another. Anytime a veteran posts comments that are
indicative of possible suicidal ideations, you can rest assured that
there will be an instant and incredible outpouring of support aimed at
that veteran, including, if necessary, calls to local public safety
officials asking that they conduct a welfare check on our veteran.
Unfortunately, as hard as we try, we've not always been successful.
We've lost far too many of our members to suicide. The vast majority of
them were directly triggered by the sense of hopelessness that often
follows a veteran's notification from the VA that his or her claim has
been denied. These tragedies must stop. Each and every veteran suicide
is completely preventable. Only the Department of Veterans Affairs has
the power to end this epidemic by improving the relevance of the
healthcare they provide, reforming their claims processing, and by
ensuring that every VA facility across this country is operating under
the exact same protocols as every other VA facility, including
healthcare facilities and VA Regional Offices where individual claims
decisions are adjudicated.
SURVEY SHOWING VA AND IOM HAVE MISSED THE MARK. Very recently, I
conducted an informal survey of sorts on the Gulf War Illnesses group
about Gulf War veterans' physical health concerns being dismissed by VA
in favor of mental health referrals. The response to that question was
rapid and voluminous. Within the first 24 hours, I had nearly 300
responses, the majority of which verified my suspicions that indeed,
this problem - that Gulf War veterans with physical health issues are
sent to VA mental health instead of addressing their physical health
issues - is widespread and extremely common in just about every region
within VA's jurisdiction. In my opinion there is little doubt that this
unethical practice is not just a Clinical Practice Guideline document
written by DOD and VA officials, it has become standard operating
procedure throughout the VA. Below is my question and a few of the
responses:
``If you are a Veteran of the 1991 Persian Gulf War and are living
with life-altering medical problems such as severe muscle or joint
pain, profound fatigue, gastrointestinal dysfunction, chronic skin
rash, cognitive difficulties, etc.....AND your complaints to VA
Physicians have not been taken seriously, I have a question to ask you.
Who among you, instead of being treated for your physical complaints at
the VA have instead been referred for psychiatric or psychological
treatment?''
u Veteran from Dallas, Texas - ``Even though I am diagnosed with
chronic fatigue (CF), Fibromyalgia, and IBS, just to name a few; The VA
still only treats me for mental health. And if they do that to me, I
can only imagine what they are doing to others. My doctors used to
think I was just a complainer because I knew too much about GWI, now I
am lucky if I ever see a doctor. All they ever give me is nurse
practitioners, and I don't know about you guys, but every time an NP
checks me out, they spend all of their time trying to un-diagnose
everything, and trying to tell me GWI is all in my head.''
u Veteran from Taylorsville, Kentucky - ``I was actually told by VA
that there were no validated reports of illnesses related to the Gulf
War.''
u Veteran from Muskogee, Oklahoma - ``During my last visit to the
Muskogee VA ER I had a doctor inform me since they could not find
anything in the X rays or blood test he was submitting a recommendation
for mental evaluation and that Gulf War Illness was not real. .. If
they have physical health conditions the doctors will minimize health
issues because of the documented psychological problems and not do as
many tests that may help them on down the road. I had many problems at
Loma Linda VA. Most consults were denied. Eventually had to go outside
VA for tests to prove conditions existed. I had to go through director
to get MRI. The MRI showed severe deterioration condition. Need 2
surgeries. I believe most veterans will have real physical issues on
down the road and will be managed by the less costly meds.''
u Veteran from Sturgis, Michigan - ``All my diagnosis [sic] were
done [by] my private pcp . VA did nothing for me. I have also been on
Zoloft since 93 for my depression tried suicide twice so been a long
hard road.''
u Veteran from Tallahassee, Alabama - ``My late husband was
referred for mental health testing six months or so before he passed in
'99...dismissed all his complaints.''
u Veteran from Springfield, Missouri - ``My primary care provider
says that my IBS, fatigue, sleep problems, etc. are all just PTSD. My
deployment to [the Persian Gulf] was actually easier and more fun than
stateside never had any traumatic experiences. Also I have never been
diagnosed with PTSD, and the psychologist says I am not depressed, just
frustrated with lack of help for my health problems.''
u Veteran from Korbel, California - ``I finally went into the VA 3
years ago because I could no longer afford an outside physician to
treat symptoms of GWI and was immediately referred to psych and
diagnosed PTSD and given a slew of placating meds. Fortunately I had
already failed off of most of them and was persistent and finally I am
getting them to treat my IBS neuropathy and fibromyalgia.''
u Veteran from Duncan, Oklahoma - ``Insomnia, chronic fatigue, skin
rash, sleep apnea. And yes sent to the shrink and tried about 4
different medications each one [expletive] me up more than the
previous. They said I was depressed within 5 minutes of appointment.
The 2nd doc said I wasn't depressed just had insomnia, prescribed
trazadone, which was the very 1st med my primary Dr. Tried. Right back
to square one. I quit going. And as far as sleep goes, I find listening
to an audio book is better than any of the meds I was on.''
u Veteran from Conyers, Georgia - ``My pcp told me she was [not]
interested in my conspiracy theories, only my current health. X-rays
put me in Phys therapy for my back. And she referred me to psych, where
I was diagnosed with PTSD.''
u Veteran from Pine Island, Minnesota - ``I was referred to mental
health after having pulmonary and cardio work-up. When I started this
time around (in 2013) I called to see what I needed to do to be seen
for the fatigue and the nurse, this was when I actually was able to
call the clinic and not triage, was honest enough to tell me that I
would have to see MH to rule out those possibilities. The psychiatrist
is the one who actually made the call on CFS. She is also the one who
told me a year later that she wasn't sure how I should be treated or
what I wanted out of continuing seeing her. .. I think many in the VA
have no idea what to do with undiagnosed, maybe [THEY] should be
referred to MH to help them find out what is wrong with them that they
cannot accept that the medical establishment has not been able to
definitively establish a diagnosis.''
u Veteran from Hawthorne, Florida - ``Gainesville VA, mental
hygiene is all they offer. Make ya think you're crazy. .. I'll never
walk [through] a VA again willingly.''
u Veteran from Geneva, Ohio - ``I have but I can say that they put
me on anxiety medication . that I have now been on for about 5 years
and it has made some good changes for sleep for me but . my body still
hurts all the time and have joint and back pain, . But still living
with headaches almost daily as well and skin rashes with severe
psoriasis and memory loss. Believe it or not as I'm writing this I have
to stop for a bit to remember names of things that I have known for
years, . this sucks especially when I have to ask my wife and she looks
at me like ``what the [expletive] is wrong with you'' and I'm only
49.''
u Veteran from Louisville, Kentucky - ``My pcp told me it was
because I am depressed and had PTSD.''
u Veteran from Parkersburg, West Virginia - ``When I first went to
the local CBOC complaining of these issues I was referred to Psych.
Later I was told all my problems were from PTSD.''
u Veteran from Topeka, Kansas - ``I was already seeing psych for
PTSD. Every visit I would tell her about my CFS, joint pain and
migraines. She was the one that actually got me the physical
appointments I needed.''
u Veteran from Northampton, Pennsylvania - ``Have all the
conditions mentioned, plus additionally shoulder pain from an injury in
the service; tinnitus; lack of sleep .. Saw the same [VA] PCP for 10
years, who didn't really take my complaints seriously .. Now seeing new
PCP; rheumatology; psychologist; & psychiatrist - and NOW they are
seeing things that were ignored for years. Never told to 'see pysch'
for pain, it was just patently ignored for years. ..''
u Veteran from Zanesville, Ohio - ``My issue has always been bad
headaches that started in country in '91, right around the time the war
started. I [go] to the Columbus Oh VA hospital and local CBOC. They
always circle around and end up putting me on mental health meds that
do nothing for the headaches and only cause negative side effects that
are much worse than the headaches alone. After a year of being on them
I took myself off for this very reason only to be put right back on
them for the very same reason. They just think they gave me the wrong
type! I feel like I gotta go thru the motion to prove they are not the
solution. I keep telling them that it is my sinuses causing them right
now and finally got an allergy Doctor to listen enough to put me on a
round of antibiotics and within a week it helped enough that my
headaches are so much better now that I do not have to take my pain
meds. After dealing w/headaches for 25 years I feel the doctors need to
listen to what we feel is causing it and what the solution may be
because I feel I know my body better than a doctor who is seeing me for
the first time.''
u Veteran from Oak Grove, Kentucky - ``I have been treated, well
seen at the Nashville VA, since 1995 and have always been told ``It's
all in my head'' and Somatoform disorder. I have all the classic
problems, PTSD, Joint pain, back pain, pain in all joints except hips.
CFS, anxiety, major depression, fibromyalgia, Migraines though the
migraines have gotten a lot better in the past few years. .. Have also
been seen at [several DOD and VA programs], All of which resulted in
[VA] trying to validate that it was all psychological / Somatoform
disorder.''
u Veteran from Cincinnati, Ohio - ``I was treated condescendingly
at the Vet Center, got referred for psych help, and prescribed various
drugs that only made things worse. Finally just quit trying, sucked it
up, and just deal with it myself as best I can.''
u Veteran from Neola, Pennsylvania - ``I was almost immediately
referred to Pysch. It has taken years, and a major decrease in my
physical ability, to get anything more than the minimum health care.
Fill me up with pills and move on. Pysch only set me up with pain
management. So on one hand they admit pain but on the other they won't
help.''
u Veteran from Hendersonville, Tennessee - ``Nashville V.A. Primary
care doc prescribed me gabapentin for my joint pain, especially in my
shoulders neck and knees. I still have extreme cramps in my legs and
calves and some serious muscle spasms, not to mention how bad my hands
shake. The fatigue, insomnia depression and anxiety my doc couldn't
figure out so I was referred to the Shrinks.''
u Veteran from Cincinnati, Ohio - ``Since I already have a [psych]
doc my physical problems are ignored.''
u Veteran from Fort Worth, Texas - ``I had a visit at the Fort
Worth Clinic where they tried referring me to psych to ``deal'' with my
pain but I basically cussed them out and shamed them then left for the
Dallas VA only to be questioned as to whether I felt safe at home or
not. It was a bad ordeal and they even put it in my records''.
u Veteran from Hampton, Virginia - ``..My husband asked my PCP if
he knew anything about the Gulf War Illnesses and he bluntly said NO.
Where did they find these doctors?''
u Veteran from Parker, Colorado - ``My pcp is vaguely familiar with
it; don't believe any [specialty doctors], GI, [for] example have any
clue about GWI or that there was even a war fought. Let alone we are
sick from it, Honestly I have a hard time bringing it up to any of them
because of the look most of them give me when I have mentioned it to
them, can't help to ask why can't there be some sort of flag like
notice in med record that says something like ``Vet is GWI Era possible
or Confirmed GWI patient'' then followed with instructions on how to
proceed''.
u Veteran from Havelock, North Carolina - ``My VA pcp is truly a
lost cause. None of the VA providers here in the VISN-6 region have
[any] clue. Since moving here to NC from KY I have had 3 VA providers.
None of which knew anything about the GWS.''
u Veteran from Dunnsville, Virginia - ``I have the same thing and
they thought it was all in my mind at first but I kept complaining. As
the time goes by the pain gets worse. I hurt and have a heart problem
that they continuously ignore''.
u Veteran from London, England - ``this is happening in the UK as
well.''
u Veteran from Denver, Colorado - ``I'm happy with my Denver VA
provider. Treats the symptoms as best as he can and makes credible
suggestions. Knowledgeable on GWI and doesn't sum it up as mental.'' -
Veteran from southern Arizona - ``You got lucky!"
CLAIMS ALSO AFFECTED. Not only are VA clinicians summarily
dismissing the complaints of veterans suffering from extremely
debilitating muscle pain, profound fatigue, chronic unexplained skin
rashes, etc., VA seems to be following that exact same model for
claims. For the veterans in this discussion group, it appears that if
the veteran agrees to be seen by mental health professionals at the VA,
it then seems like his or her chances of getting a disability claim
approved are almost assured, whereas those who reject treatment by VA
psychiatrists or psychologists seem more likely to have their claim
denied. The following is a sampling of comments related to claims that
various members of the Gulf War Illnesses Facebook page posted after I
had asked the aforementioned question:
u Veteran from Muskogee, Oklahoma - ``.. VA claims are easier for
those claiming psychological (PTSD) issues but think it is bad for the
veteran. If they have physical health conditions the doctors will
minimize health issues because of the documented psychological problems
and not do as many tests that may help them on down the road. ..''
u Veteran from Muscle Shoals, Alabama - ``When I received my letter
denying my claim for stomach cancer the nurse that did the evaluation
said my cancer was caused by SAD. Severe Anxiety Disorder. I have never
been diagnosed by any Psychiatrist or psychologist???''
u Veteran from Neosho, Missouri - ``I'm rated 90 percent with IU,
but all my complaints and gulf war illnesses were denied individually
and all was put under PTSD, filed claim at mount Vernon, Missouri and
regional office St Louis, so yeah they did it wrong, but not going to
rock the boat when I got total and permanent.''
u Veteran from Coatesville, Pennsylvania - ``Been seen for all and
VA comes back and says not service related.''
u Veteran from Las Vegas, Nevada - ``Tomah VA treated both mental
health and primary care until the OIG Investigation had them on
Administrative Leave. Then nobody treated me until I filed a
Congressional Complaint and spoke to Carolyn Clancy...Nothing got done
still with referrals after their negligence. A few months later the PCP
agreed to PTSD inpatient, but again stone-walled by their staff so it
would look like my denial was my fault. I have all of the diagnosis and
claim is still pending while now being referred in Las Vegas for
numerous medical treatments. They don't acknowledge GWI here...then
again they don't anywhere.''
u Veteran from Allegan, Michigan - ``In 1993 went to Los Angeles VA
they pushed me through said nothing was wrong. In 2003 went to Phoenix
VA same thing. In 2008 went to Sacramento VA was told I wasn't eligible
for benefits. 2011 I was diagnosed by civilian Dr. with ulcerative
colitis. 2013 had BCIR surgery by civilian Dr. 2014 registered at the
Chicago VA never made an appointment because people are just plain mean
there. In 2015 went to Wyoming Michigan VA. They have yet to do
anything about my headaches, fatigue and joint pain, went through the
shrink thing made them stop. 9 months later and I received 100%
disability just for ulcerative colitis, 50% PTSD.''
u Veteran from Topeka, Kansas - ``I filed for undiagnosed illnesses
of chronic fatigue and joint pain in 95. Denied for both but my VSO had
added PTSD. (I was diagnosed with chronic fatigue and PTSD only at that
time. ) I have now managed to get a listing dx of CFS.''
u Veteran from Oak Grove, Kentucky - ``Only reason I kept going was
because my claim was pending and if I didn't, they would say, I
``refused treatment''. Don't think any of my ratings are considered
service connected or not. Afraid to mess with it as I'm getting ..
[100% Individual Unemployability] so I'm leaving it alone for now.''
u Veteran from Eads, Tennessee - ``As soon as the VA read the words
``stress'' in my application for C& P for numerous ailments with
unknown etiology from Desert Shield/Desert Storm I was sent to a
psychologist at Memphis VA hospital for evaluation....you don't need to
hear what he wrote....I felt betrayed and haven't been back since.''
CONCLUSIONS
Gulf War Illness is a physiological illness, period. That's not
just the opinion of this very ill veterans' advocate and multi-year
CDMRP participant, it is the opinion of hundreds of Ph.D's and M.D.s
who have studied Gulf War Illness over the past decade. These are
highly skilled experts in the fields of science and medicine.
It's long past the time when the self-serving interests of
political operatives and defense contractors trump the medical and
financial needs of the more than 200,000 of America's 1991 Persian Gulf
War veterans whose good health and ability to support their families is
nothing more than a distant memory. This American tragedy must be
brought to end, once and for all. History is watching, and everyone
involved will be judged according to his or her actions, or inaction.
Which side of history will you be on?
Very Respectfully Submitted,
David Keith Winnett, Jr.
Captain, United States Marine Corps (Retired)
Representing: Veterans for Common Sense
Home address: New Braunfels, Texas
LEA STEELE, PH.D.
Yudofsky Chair in Behavioral Neuroscience, Professor of
Neuropsychiatry
Baylor College of Medicine
My name is Dr. Lea Steele. I am a neuroepidemiologist and have
conducted research on the health of Gulf War veterans since the late
1990s. Our initial efforts were sponsored by the State of Kansas, where
we worked with state officials to establish a research and outreach
program for Persian Gulf War veterans in Kansas, collaborating with
Kansas State University. Since those early years I have continued
clinical and population research on Gulf War health issues and have
served on multiple federal Gulf War research panels, including 5 years
as Scientific Director of the Congressionally-mandated Research
Advisory Committee on Gulf War Veterans' Illnesses. I am currently a
professor at Baylor College of Medicine in Houston, where our veterans'
health research continues.
I am submitting this statement to offer my perspective, as an
experienced Gulf War scientist, on where things stand with federal
efforts to address health outcomes in 1991 Gulf War veterans, 25 years
after Desert Storm. With respect to Gulf War illness (GWI), the
signature health problem of the 1991 Gulf War, we have seen significant
progress in understanding its nature and its causes, and the magnitude
of the problem. We can diagnose GWI by its consistent profile of
symptoms that have now persisted, for many veterans, for 25 years.
Symptoms include chronic headaches, widespread pain, debilitating
fatigue, cognitive difficulties and other concurrent problems. We know
GWI affects a substantial proportion of the nearly 700,000 veterans who
served in Desert Storm-roughly 25-30%. We know GWI is not a psychiatric
disorder and was not caused by combat or stress-PTSD rates are
relatively low in Gulf War veterans, as expected from the four day
ground war in which most personnel did not see combat. Rather, research
has most consistently pointed to chemical exposures widely encountered
by veterans during deployment-toxicants that, individually and in
combination, have long-term adverse effects on the brain and other
systems.
I want to emphasize just how consequential this scientific progress
has been, and the promise it offers for understanding GWI, for avoiding
this problem in future deployments, and for near-term identification of
diagnostic tests and treatments for veterans who have suffered for so
long.
Gulf War illness is a complex disorder that was long denied or
minimized by federal agencies charged with addressing it. The fact that
we have learned so much about the nature and causes of GWI, especially
in the last 10 years, is the result of several important factors: the
persistence and dedication of Gulf War veterans who have continued to
push federal agencies to find answers and treatments, the persistence
of Congress in directing that government agencies provide the needed
research, healthcare, and benefits, and the diligent work of dedicated
scientists.
Still, despite impressive progress, the most essential work
remains. That work is to ensure that the large number of veterans who
still suffer from the long term medical consequences of service in the
1991 Gulf War are diagnosed and effectively treated. This effort is
underway, and scientists working in this arena are now seeing returns
in the push to better understand the biology of GWI and identify
treatments that significantly improve the health of Gulf War veterans.
This is exemplified by the rapid expansion of treatment studies-both in
ill Gulf War veterans and animal models of Gulf War illness-sponsored
in recent years by the DOD's Office of Congressionally Directed Medical
Research Programs (CDMRP).
While the DOD, researchers, and veterans have made important
strides in understanding and addressing this serious problem, VA has
lagged behind in providing an effective response to Gulf War health
issues. The poor response was more understandable in the early years
after the Gulf War, when little was understood about this problem. But
it continues today, reflected day in day out in the difficulties Gulf
War veterans face in obtaining effective care at VA. These pervasive
problems are also evident in the Clinical Practice Guidelines issued in
2014 to inform VA healthcare providers about treatment options for
veterans with Gulf War illness. They are evident in the lack of the
fundamental VA research necessary to inform IOM panels and the
Secretary of Veterans Affairs concerning benefits decisions. And they
are evident in ill-informed findings resulting from a piecemeal
approach to the evidence considered in a recent IOM report commissioned
and charged by VA.
With regard to the recent treatment guidelines and IOM report, a
long list of specific examples could be provided that illustrate the
limitations, misassumptions, and errors contained in these documents.
For those experienced in conducting research and caring for ill Gulf
War veterans, these reports are the latest in a long line of clinical
and research missteps from VA. In many ways, they harken back to the
1990s, before the now extensive evidence was available to inform our
understanding of GWI, and guide the steps required to effectively
address it.
For example, the recent IOM report states that Gulf War illness
studies have largely excluded psychological problems and recommends
that future efforts incorporate mind-body approaches to this problem.
In fact, the opposite is true. Gulf War studies have always included
psychological issues and, until recent years, focused more heavily on
psychological factors than any other single area. Research consistently
found no association between combat stress and GWI, and studies found
little effect of behavioral therapies in improving veterans' symptoms.
Today, stress is no longer the central focus of GWI research. But
studies continue to evaluate psychological symptoms and psychiatric
comorbidities in Gulf War veterans, and treatment studies are testing
mind-body therapeutic interventions to alleviate veterans' symptoms. To
suggest an increased emphasis on psychological factors and
interventions is baffling and misrepresents widely available evidence.
Similarly, the 2014 Clinical Practice Guidelines for VA healthcare
providers emphasize the use of psychiatric medications and behavioral
interventions, despite there being no evidence that these treatments
provide meaningful benefit for veterans with GWI. Studies, again, have
demonstrated just the opposite, that behavioral interventions provide
little benefit for veterans with GWI. Proceeding in the direction
suggested by just these two examples would misdirect precious resources
and, more importantly, further delay the appropriate medical care
needed by veterans.
From my perspective as a scientist, there are two common threads
that have undermined the effectiveness of VA programs to effectively
address GWI. (1) VA's ongoing failure to affirmatively engage GWI as a
medical condition that affects veterans as a result of their deployment
to the Kuwaiti Theater of Operations in 1990-1991. The most fundamental
essentials are lacking. VA still does not refer to this condition by an
identifiable name and VA clinicians have few resources and little
training in how best to assist veterans with this condition. (2) VA's
failure to bring in experts to develop and steer healthcare and
research programs that effectively address Gulf War health issues. Gulf
War illness is a complex and unfamiliar medical condition, and
effective VA programs require scientific and clinical expertise
specific to this problem. In contrast to VA, the scientific progress
brought about by DOD's effective Gulf War Illness Research Program in
recent years can be traced directly to DOD's developing this program in
partnership with scientific experts who are most experienced in Gulf
War research and Gulf War veterans who are most affected by this
problem.
It goes without saying that Gulf War veterans deserve clear
answers, effective healthcare, and informed research to improve their
health. It is a travesty that, 25 years after the brief war and heroic
victory achieved by the military in Operation Desert Storm, veterans
who served in that war continue to have to fight for recognition, care,
and benefits for the long-term health problems they still suffer as a
consequence of their service.
Questions For The Record
Questions from Chairman Mike Coffman for the Department of Veterans
Affairs:
Question 1: According to the 2013 report of the Institute of
Medicine (IOM), studies referenced were from 2008 and earlier and
provided a disclaimer that drug manufacturers may have influenced
several clinical trials or employed researchers. VA used those same
studies in writing its guidelines. Was VA aware of the potential that
its guidelines are based on questionable material?
VA Response: Yes, VA was aware of such concerns. VA and the
Department of Defense (DoD) have a rigorous process for assessing and
rating the quality of published studies used in the development of our
joint Clinical Practice Guidelines (CPGs). More specifically, this
process was used in the development of the DoD/VA Chronic Multi-Symptom
Illness Clinical Practice Guideline.
Question 2: That same IOM report noted a high risk of bias for a
number of studies that are also referenced as sources for VA's
treatment of Gulf War Veterans. Was VA aware of this when it used them
to create the guidelines?
VA Response: Yes, as mentioned above, VA was aware of such concerns
and addressed them in the process of development of DoD/VA CPGs through
a process of rating the strength and quality of various studies being
considered.
Questions 3: Since VA wrote the contract that employed IOM for the
study, why didn't VA exclude questionable or high risk material in the
study or do so in the results the department continued to tout?
VA Response: Because scientific and clinical evidence exists on a
spectrum of strength and quality, VA, IOM, DoD and similar
organizations, as well as scientific researchers evaluate the
``strengths and limitations'' of studies and research based evidence.
That is the approach used in the interpretation of IOM reports as well
as in the development of DoD/VA CPGs.
Question 4: VA's guidelines state ``an internal working document''
of VHA and DOD was used in developing the guidelines. Please provide
that document in its entirety.
VA Response: The ``internal working document'' identified in the
request is the ``Guideline for Guidelines'' which can be accessed
directly at http://www.healthquality.va.gov/documents/
cpgGuidelinesForGuidelinesFinalRevisions051214.docx.
This document outlines the process from start to finish for the
development of VA/DoD CPGs. It covers such areas as: identifying and
requesting a VA/DoD CPG be developed, identifying subject matter
experts from both VA and DoD agencies, methodology for key question
development and evidence review, evidence grading, potential conflict
of interest, adapting/adopting/new CPG development, internal/external
review and approval process.
Question 5: It has been forty years since the Vietnam War ended and
Veterans had to fight for care related to Agent Orange. It has been
twenty-five years since the Persian Gulf War, and Veterans are still
fighting for their care. Now, Veterans are also dealing with burn pits
and other toxic related issues. Is VA getting the occupational and
environmental health surveillance data that it needs from DOD in order
to care for Veterans properly? If not, what additional data would be
helpful and why?
VA Response: Unfortunately, for many Veterans, particularly those
of the Vietnam and the Persian Gulf Wars, it appears that reliable
occupational and environmental health surveillance data just do not
exist. To the extent that such data are available, DoD shares them with
VA as needed. DoD has much better surveillance data available for more
recent conflicts and events.
Building on the lessons learned from the Persian Gulf War,
Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and
Operation New Dawn (OND), VA and DoD work collaboratively to identify
and measure military related exposures, to identify those potentially
exposed, and to generate risk estimates for any known or potential
acute and long term health effects.
The evolution of the Agent Orange benefits program is an excellent
example of the progress VA has made in terms of support for individuals
with deployment related environmental exposures. It is an extremely
``worker friendly policy'' for those whose health may have been
negatively impacted by dioxin exposure in the places and time periods
designated. The Airborne Hazards and Open Burn Pit Registry is also a
measure of how much more proactively we are approaching the
documentation, assessment, and monitoring of deployment related
exposure concerns. http://www.va.gov/HEALTH/NewsFeatures/2016/March/
Were-you-exposed-to-burn-pits-while-deployed.asp.
The Tomodachi Registry of about 75,000 DoD-affiliated individuals
(Service members, family members, veterans, contractors) in the
vicinity of Japanese Dai-ichi reactor meltdown was created and
populated immediately after the disaster and includes individual- and
geolocation-sampling readings of ionizing radiation exposure levels.
This registry could prove very useful in the future, as needs arise for
potential future follow-up in the overall health of this Veteran
population.
A major emphasis of the DoD/VA Deployment Health Work Group (DHWG)
is on Service members returning from OEF, OIF, or OND. The DHWG also
coordinates initiatives related to Veterans of all eras. Joint efforts
continue to increase sharing of health surveillance information and
review of relevant literature on hazardous environmental exposures, so
that risky situations in theater are identified, and the Department's
responses are appropriately coordinated. The DHWG analyzed complex
clinical medicine, toxicology, and policy aspects to develop
synchronized DoD and VA actions. The DHWG organized twelve meetings in
FY15 to coordinate DoD and VA responses to five major environmental
exposures in Iraq, Afghanistan, and the US, as described below:
potential health effects of exposure to burn pit smoke in
OEF/OIF/OND
potential health effects of high ambient concentrations
of particulate matter in OEF/OIF/OND
potential health effects of chemical warfare agent
exposure in OIF
potential health effects of historical exposure to
contaminated drinking water at Marine Corps Base Camp Lejeune, NC
potential health effects of exposure to Agent Orange
during and after the Vietnam War
The DHWG provides ongoing oversight of the development of the
Individual Longitudinal Exposure Record (ILER) project, including
briefings every two months. The goal of ILER is to create a complete
record of every Service member's occupational and environmental
exposures over the course of their career. ILER is a $19.1 million
jointly funded pilot project and the goals are: to demonstrate the
feasibility of producing ILER; and to develop a prototype that provides
an initial operating capacity (IOC). At IOC, DoD and VA will decide
whether to proceed to Full Operating Capability, which would require
considerable sustainment funding from both Departments in future years.
The ILER will mine several existing DoD data systems that contain
in-garrison and deployment exposure-related information. It will link
career location and year with exposure data and will be available to
DoD and VA health care providers to help inform diagnosis and
treatment, and to VBA claims adjudicators to help establish service
connection. This will assist Veterans in establishing their individual
exposures.
Question 6: In 2015, GAO reported that DOD provided VA with access
to unclassified summaries of historical environmental health
surveillance monitoring efforts through a website. The summaries are
referred to as POEMS (or Periodic Occupational and Environmental
Monitoring Summaries). However, VA officials were uncertain about how
often these summaries were being used. Is VA using these summaries, and
if so, how often and to what extent?
VA Response: Clinicians at the War Related Illness and Injury Study
Centers (WRIISCs) perform specialty consultations about the
environmental and occupational health and exposure concerns of Veterans
referred for evaluation. They use their expertise to regularly
incorporate information from the POEMs and the online information
request services available from the Army Public Health Center, as well
as personal contacts at the Army Public Health Center and the Navy and
Marine Corps Public Health Center to complete their assessments and
recommendations. The services of Army Public Health Center are
available to any clinician or patient according to their website, but
are perhaps most suitable to specialty evaluations.
Here is the website for the Army Public Health Center. More detail
is available here under the ``topics and services'' and ``request
services'' tabs. https://phc.amedd.army.mil/Pages/default.aspx.
Question 7: How does VA use DOD's occupational and environmental
health surveillance data? Does it play a role in how VA treats patients
with Gulf War Illnesses? If so, please explain in detail.
VA Response: DoD's occupational and environmental health
surveillance data are used in accordance with its completeness,
accuracy, and relevance to help address the health concerns reported by
Veterans. The DoD has provided tremendous support in the development of
an Airborne Hazards and Open Burn Pit Registry by providing data for
pre-population of deployment dates and locations using information from
existing DoD databases. Earlier efforts to construct a model of the
plume of low-dose chemical warfare agent dispersion from the Kamisiyah
demolition have been subject to criticism by GAO and IOM, but used the
best data and methodologies available at the time to understand the
exposure. Treatment decisions are handled based on clinical
presentation of the individual patient, including the Veteran's self-
reported history of exposures and the scientific soundness and safety
of available therapy options.
In the routine care of Veterans, clinicians are encouraged to ask
Veterans about their military experience, and in the case of
specialized assessments, utilize principles of occupational medicine
and knowledge about known hazards to reconstruct a self-reported
exposure assessment. This can then be used by clinicians to estimate
the extent of their patients' possible exposure to such hazards and to
develop a crude probability of any known or possible long term health
effects related to these exposure(s). The treating providers then
continue to monitor these patients for any possible associated
condition(s) that may clinically manifest as a result of their in-
service exposure to such hazards. It is important to recognize that
clinicians will also treat patients with known or suspected exposures
in a holistic and caring matter.
Question 8: IOM Volume 8 noted a fifteen percent excess of lung
cancer for Gulf War Veterans and recommended further follow up because
``cancer incidence in the past 10 years has not been reported.'' Yet,
IOM Volume 10 mentions a lack of sufficient evidence between deployment
to the Gulf War and any form of cancer. Please provide the updated
disease specific incidence and mortality data accounting for this
change.
VA Response: The IOM Volume 10 does not have readily available
disease specific cancer mortality that would compare deployed and non-
deployed populations. The IOM however used several studies to study
cancer incidence. A recent study of Australian Veterans showed no
definitive difference in deployed versus non-deployed Veterans for any
cancer except for a statistically significant increase in thyroid
cancer based on five events. (Sim et al., 2015) \1\ A large scale
second study looked at Veterans diagnosed with cancer using data from
the Defense Manpower Data Center, which was linked to central cancer
registries in 28 states and to the VA Central Cancer Registry. Using
statistical methods that included regression analyses, lung cancer was
the only site-specific cancer found to have a significantly higher
proportion among deployed Veterans compared with non-deployed era
Veterans (PIR = 1.15, 95 percent CI 1.03-1.29). [Note: this appears to
be the 15 percent increase cited above and is found in Volume 10]
However, the risk was not increased over the general population. An
important caveat is that smoking history, the known primary cause of
lung cancer, was not controlled for in the study. Other cancers did not
show an elevation of risk. Overall, after controlling for age, race,
and sex, there was no significant association between Gulf status and
the proportion of Veterans with a cancer (odds ratio, 0.99; 95 percent
CI, 0.96-1.02) identified from a state registry. (Young et al., 2010).
\2\
---------------------------------------------------------------------------
\1\ Sim, M., D. Clarke, B. Forbes, D. Glass, S. Gwini, J. Ikin, H.
Kelsall, D. McKenzie, B. Wright, A. McFarlane, M. Creamer, and K.
Horsley. 2015. Australian Gulf War Veterans' follow up health study:
Technical report 2015. Canberra, Australia: Department of Veterans'
Affairs.
\2\ Young, H. A., J. D. Maillard, P. H. Levine, S. J. Simmens, C.
M. Mahan, and H. K. Kang. 2010. Investigating the risk of cancer in
1990-1991 U.S. Gulf War Veterans with the use of state cancer registry
data. Annals of Epidemiology 20(4):265-272.
---------------------------------------------------------------------------
It is important to recognize, however, as the IOM Volume 10 states:
the length of follow-up was, at most, 15 years, which may not be enough
time for certain cancers such as lung cancer to develop if there were a
Gulf War exposure factor. A study led by VA (Dursa et. al., 2016) \3\
used survey data of thousands of Veterans and demonstrated no
statistical increase in cancers, but brain cancer was slightly elevated
at 1.02 OR. Finally, VA provided a health care use report for Gulf War
era deployed and non-deployed Veterans who sought care in VA facilities
from October 2001 to December 2013. These VA health care users
represent 46 percent of all deployed Gulf War Veterans and 36 percent
of all non-deployed era Veterans. This data also has deployed Veterans
with a slightly lower percentage of lung or trachea cancers (6.0
percent versus. 6.3 percent) out of all cancers diagnoses than non-
deployed Veterans. Importantly, an ongoing VA technical workgroup,
which includes VA, will look closely at all available data/cited
publications on all cancers, and especially, review the results for
lung cancer for its upcoming technical workgroup report and
recommendations to the Secretary.
---------------------------------------------------------------------------
\3\ Dursa, E. K., S. K. Barth, A. I. Schneiderman, and R. M.
Bossarte. 2016. Physical and mental health status of Gulf War and Gulf
era Veterans. Journal of Occupational and Environmental Medicine
58(1):41-46.
Question 9: Given the O&I hearing in June 2015, where videos of VA
employees acknowledged that the department is making drug addicts out
of Veterans and the CDC and American Medical Association's concerns
related to overmedication were highlighted, why is VA prescribing these
---------------------------------------------------------------------------
serious drugs for Gulf War Illness?
VA Response: Some of the drug categories of concern due to their
potential to cause addiction and/or unintentional overdose (or other
adverse outcomes) are opioid medications, benzodiazepines (medications
for sleep and anxiety), stimulants, immunotherapies, antibiotics and
corticosteroids. These are specifically mentioned as medications to
avoid as treatments for Gulf War Illness (GWI) related CMI in Veterans
unless clinically indicated for co-occurring conditions With respect to
opioids in particular, the guideline states ``Avoid the long-term use
of opioid medications'' unless clinically indicated. In general, the
CPG suggests that treatment teams ``Maximize the use of non-
pharmacologic therapies''.
Question 10: In its 2011 report, the IOM recommended that
additional studies of health effects in Veterans deployed to Iraq and
Afghanistan were needed to help determine whether certain long-term
health effects were likely to result from exposure to burn pits during
deployments. Please describe the research VA conducted in response to
this recommendation.
VA Response: VA and DoD research on respiratory illness among
Veterans deployed to Iraq and Afghanistan is focused on: (1)
determining the prevalence and severity of lung disease associated with
deployment to South West Asia, (SWA) and, (2) identifying the
geographical, behavioral, medical, and causative factors related to
deployment associated lung disease.
In 2013, VA's East Orange, New Jersey WRIISC launched the Airborne
Hazards Center of Excellence to provide comprehensive medical
evaluations focused on the respiratory health in deployed Veterans.
Their clinical research has addressed several important gaps in the
diagnostic evaluation of symptomatic Veterans, in addition to
addressing Veterans' health concerns through direct patient care. Their
research efforts have resulted in 12 peer-reviewed publications, eight
conference abstracts, and a book chapter. East Orange WRIISC
researchers reviewed data published from 2001 to 2014 pertaining to
respiratory health in military personnel deployed to Iraq and/or
Afghanistan and found 19 unique studies. In summary, published data
based on case reports and retrospective cohort studies suggest a higher
prevalence of respiratory symptoms and respiratory illness in Veterans
deployed to Iraq and/or Afghanistan. However, the association between
chronic lung disease and airborne hazards exposure requires further
longitudinal research studies with objective pulmonary assessments.
VA's Office of Research and Development (ORD) funds research
projects that address respiratory health issues in Veterans deployed to
Iraq and Afghanistan. ORD's Request for Applications under the ``Merit
Review Award for Deployment Health Research OEF/OIF/OND'' lists the
health effects of burn pits as a specific area of emphasis.
ORD funded research projects completed in 2015:
Effects of Deployment Exposures on Cardiopulmonary and
Autonomic Function; Investigator: Michael Falvo, PhD; East Orange, New
Jersey
Nanoparticle Coupled Antioxidants for Respiratory Illness
in Veterans; Investigator: Rodney Schlosser, MD; Charleston, Sout
Carolina
Ongoing ORD funded research:
Mechanisms of Cigarette Smoke-Induced Acute Lung Injury;
Investigator: Sharon Rounds, MD; Providence, Rhode Island (7/1/2015-6/
30/2019)
Carbon Black Induced Activation of Lung Antigen-
Presenting Cells (APCs); Investigator: David B. Corry, MD; Houston,
Texas (7/1/2013-6/30/2017)
Targeting HSC-derived Circulating Fibroblast Precursors
in Pulmonary Fibrosis; Investigator: Amanda C. LaRue, PhD; Charleston,
South Carolina
(10/1/2013-9/30/2017).
VA continues to make use of longitudinal research studies to
evaluate the respiratory health of deployed Veterans. VA and DoD have
developed an Interagency Agreement to support the joint examination of
data collected by the Millennium Cohort Study. The aim of this
collaboration is to evaluate the impact of military service on health
and disease over time.
The VA-led National Health Study of a New Generation of US Veterans
sampled 60,000 OEF/OIF deployed Service members and non-deployed
Veterans in 2008, and administered a survey that included self-reported
measures of exposure and disease. The New Generation study has resulted
in one publication analyzing prevalence of respiratory diseases, and
additional analyses are underway.
In addition, VA conducts ongoing surveillance of VA health care
utilization through systematic reviews and investigation of diseases
treated. This surveillance drives in-depth investigation of areas of
special concern, such as respiratory diseases. These studies enable VA
to identify potential adverse health effects associated with
deployment, including respiratory disease, and follow them over time.
Question 11: On February 11th, VA issued its final report on Gulf
War Illness, which had similar findings to IOM's previous report. IOM
concluded that future research efforts need to focus on the
interconnectedness of the brain and the rest of the body's organ
systems when seeking to improve treatment of Veterans for Gulf War
Illness. What actions, if any, does VA plan to take in response to this
report?
VA Response: VA has implemented a technical workgroup (see VA
Response for Question 16 for details) to review all the recommendations
in this report and to provide recommendations in response to the report
to the Secretary of Veterans Affairs. This will include a review of
this important recommendation. VA also plans to have listening sessions
in the near future with Veterans to get their input into this and other
IOM recommendations, as well as getting that of the Research Advisory
Committee on Gulf War Veterans' Illnesses. The VA takes seriously the
idea that ongoing research will need to focus on the holistic treatment
of Veterans; as such, VA research will aim to find solutions that take
into account the inter-connectedness of the brain with other organ
systems.
One area where VA is increasing its focus is Integrative Health
Care (IHC). Still, we caution that positive research findings related
to use of IHC do not automatically translate into available clinical
services, because VA may only provide care that is in accord with
generally accepted standards of medical practice and is needed to
promote, preserve, or restore health as provided in 38 Code of Federal
Regulations 17.38(b). To this end, VA is conducting a randomized
control trial, entitled ``Complementary and Alternative Medicine (CAM)
for Sleep, Health Functioning, and Quality of Life in Veterans with
Gulf War (GW) Veterans' Illnesses'','' also referred to as the GW-CAM
Study. This study examines Gulf War Veterans Illness by assessing the
hallmark conditions of pain, fatigue, sleep and cognitive difficulty,
and the efficacy of a CAM intervention on these conditions. To further
expand our understanding of Gulf War Veterans Illness and the efficacy
of a CAM treatment intervention, the GW-CAM Study has also partnered
with the Department of Defense to develop a brain imaging protocol that
will be incorporated into the GW-CAM Study.
Question 12: Dr. Hunt's testimony was that psychiatric medications
should not be given for Gulf War Illness and yet the clinical
guidelines created and promulgated by VA (including Dr. Hunt)
recommending numerous pharmacologic agents for Gulf War Illness. Please
explain this discrepancy in detail.
VA Response: The Chronic Multi-Symptom Illness (CMI) CPG is based
upon current evidence-based approaches to CMI. The specific symptoms
experienced by Gulf War Veterans vary from one Veteran to another.
Given that treatment for CMI/Gulf War Illness is primarily aimed at
symptom management, the treatment approaches are personalized and will
vary from Veteran to Veteran, depending upon whether an individual has
fatigue, pain, cognitive disturbances, gastrointestinal disorders or
other symptoms as their predominant manifestation of CMI.
Certain medications that are also used for depression, such as
selective serotonin reuptake inhibitors and serotonin-norepinephrine
reuptake inhibitors (SNRI's) have also been found to be helpful in
symptom reduction in individuals with pain-predominant CMI, fatigue
predominant CMI or global symptoms CMI. These medications, when
clinically appropriate and used in the care of Gulf War Veterans are
not being used as ``psychiatric medications''. They are being used to
offer relief from specific symptoms or combinations of symptoms. In
general, the CPG advocates treatment teams to ``Maximize the use of
non-pharmacologic therapies'' as clinically appropriate; again, our
providers must abide by the applicable standards of care and these may
involve the use of certain drugs in a particular patient case,
especially where the use of non-pharmacologic therapies has not been
effective.
Question 13: Dr. Hunt's presentation titled ''A Model for Providing
Services for Returning Combat Veterans,'' implies that he and others in
VA believe Gulf War Illness is a ``mental disorder.'' This is further
substantiated in Dr. Hunt's Community of Practice call conducted
Friday, March 11th. During this call, VA discussed issues related to
our subcommittee's hearing held on February 23rd. The call included
more than fifty participants, and it discussed how to improve care for
Veterans suffering from Gulf War Illness. Unfortunately, the majority
of the attention was given to a presentation by Dr. David Kearney
regarding chronic pain, with what seemed to be an emphasis on PTSD -
and the use of mindfulness as a method of treatment for Gulf War
Illness. Please explain in detail the discrepancy in Dr. Hunt's public
statements and his internal VA discussions and presentations.
VA Response: Dr. Hunt's presentation, ''A Model for Providing
Services for Returning Combat Veterans,'' was not intended to imply
that he and others in VA believe Gulf War Illness is a ``mental
disorder.'' The presentation focuses on the importance of understanding
and responding effectively to the complex experience of combat.
Environmental exposures are one aspect of that experience, and a
particularly important aspect in our Gulf War Veterans as is pointed
out in slides 25 - 32 presented to the Committee. This is important
whether considering entitlement to benefits administered by VHA or VBA.
The importance of assisting Veterans in accessing benefits is mentioned
in several slides that were presented.
Question 14: Does Dr. Hunt believe Gulf War Illness is specifically
a mental, psychiatric, psychologic, or psychosomatic issue? Please do
not convolute the answer by discussing the obvious mind-body connection
associated with how the brain works in relation to body mechanics.
VA Response: No. As Dr. Hunt stated in his testimony, he does not
believe that Gulf War illness is specifically a mental, psychiatric,
psychological, or psychosomatic issue. Dr. Hunt's board certification
is in Occupational and Environmental medicine, the medical specialty
that focuses on toxic exposures in the home, workplace, and other
external environments. He is a Clinical Associate Professor in this
program at the University of Washington. From the beginning, his work
with Gulf War Veterans has been oriented primarily towards ensuring
that they receive the care that will most effectively support them.
He has admittedly been very concerned that at times the debate over
``what causes Gulf War Illness'' (a challenging, but nonetheless
extremely important, question that still has not been answered after 25
years of research) has distracted both the clinical and research
communities from offering effective support for these Veterans. He does
not question the fact that environmental exposures have contributed to
the health concerns of GW Veterans and consistently promotes two
important parallel courses of action:
1.Ongoing research to identify specific causal relationships
between specific exposures (or combinations of exposures) and health
conditions in GW Veterans so that specific targeted treatments can be
established (such as CoQ10 which he mentioned in his testimony); and,
2.Until such relationships and targeted treatments are clearly
established, clinicians must provide effective condition-specific
treatment. General and specialist health care is available under VA's
medical benefits package to enrolled Veterans to ensure they do well.
VA's treatment authority for GW Veterans is broadly worded and permits
VA to treat them at no cost for conditions that may be associated with
their service in the Gulf War; not withstanding the current lack of
evidence that such a condition (s) is associated with such service.
Only those conditions that can be ruled out by the USH as not being
associated with such service are excluded and those are few in number.
Quesiton 15: Many Veterans have complained that VA's questionnaires
to Veterans suffering from Gulf War Illness (GWI) are worded in such a
way to reach a preconceived finding that GWI is a mental issue or a
PTSD issue. Please submit all such questionnaires provided to Veterans
and all responses from the recipients of the questionnaire.
VA Response: VA has conducted a number of research studies on the
health concerns of Gulf War Veterans. The largest study has followed
the same panel of 30,000 Gulf War Era Veterans with three surveys since
1995; half of the Veterans selected for the study deployed to the Gulf
and the other half served elsewhere. The goal of this study was to
assess the health of Gulf War and Gulf War Era Veterans. Each of three
surveys administered over this period has asked a core set of questions
important for assessing major domains of well-being, illness, and
health determinants, or risk factors. Health has many domains:
physical, mental, reproductive, functional, and social. This study
completed its most recent follow up assessment in 2012 was a
comprehensive assessment of multiple domains of health among Gulf War
and Gulf War Era Veterans. While certain health conditions may be more
prevalent among Gulf War Veterans, the purpose of this study is not to
focus on one particular domain or health condition, but to present a
population level assessment of the health of Gulf War and Gulf War Era
Veterans.
This will help VA better understand any possible associations
between their service and the clinical symptoms, and so better serve
this population of Veterans. The questionnaire included standard
validated scales and screening tools that are used widely both in
clinical practice and in research. The inclusion of questions that
measure symptoms of PTSD and other mental health conditions is based on
evidence from the peer-reviewed literature that demonstrates these
conditions are prevalent among Veterans (regardless of era or
deployment status) and are associated with poor health outcomes
overall. The principles of good questionnaire design dictate the
selection of validated scales, construction of clear questions, and
layout choices that elicits information in an unbiased fashion; the
questionnaires used to study this panel of Gulf War Era Veterans have
not been worded in such a way as to reach a preconceived result
regarding the etiology of GWI or any association it may have with
mental health symptoms or PTSD. This study has consistently provided
evidence that Gulf War Veterans who deployed are sicker than their non-
deployed peers. Notably, this study provided early evidence to support
the understanding of Gulf War Illnesses as a multisystem illness state.
Copies of the IRB and OMB-approved surveys that were sent to
Veteran participants of this study in 1995, 2005, and 2012 are
attached. VA cannot provide all responses from the recipients of the
questionnaires; as the research participants did not consent to have
their individual data shared.
Question 16: Given VA's public acknowledgement that Gulf War
Illness is a biological disorder, please explain why VA's clinical
treatment protocols treat it as a psychological disorder.
VA Response: The DoD/VA CMI CPG does not treat GWI as a
psychological disorder. It can be found on the web page of the DoD/VA
Clinical Practice Guidelines in the section of ``Military Related.'' It
is not included in the section of the website where DoD/VA's related
CPGs to mental health are found. http://www.healthquality.va.gov/. This
underscores that it is considered to be a deployment health matter. The
CPG is meant to offer guidance in how to provide effective care for
Veterans with CMI. It begins by advocating that each Veteran be
assigned a basic medical team ``including a behavioral health
specialist in Primary Care.'' This is standard for all Veterans
enrolled in VA's health care system, particularly those who have been
deployed to combat theaters. ``Deployment related exposures'' are one
of a number of ``critical domains'' for knowledge on these teams. The
standard of care in VA is to have behavioral health available for any
Veteran who needs it through their expanded Patient Aligned Care Team.
Question 17: What is VA's opinion of IOM's conclusions in its most
recent report given the similarities with its last report? Is VA
satisfied that sufficient progress is being made to identify and better
understand the causes of Gulf War Illness?
VA Response: A technical workgroup (TWG) of VA subject matter
experts has been assembled to review IOM's report, Gulf War and Health:
Volume 10: Update of Health Effects of Serving in the Gulf War, 2016.
This TWG is working to determine how the findings and recommendations
might help to identify possible adverse health effects related to such
service in order to make a recommendation to the VA Secretary as to
whether to establish a presumption of service-connection for a certain
condition(s). This review will also include all other information and
peer-reviewed literature which have become recently available. The TWG
will draft a formal VA response document with recommended courses of
action which will then be carefully staffed through senior leadership.
Ultimately, the recommendations will go to the Secretary of Veterans
Affairs for decision. This process is expected to take 3 - 4 months. VA
would be happy to discuss our ongoing process in this regard, but feel
that it is presently premature to discuss our impressions or views.
Question 18: What is VA's opinion of IOM's decision not to consider
the results of animal research in its conclusions?
VA Response: The IOM committee conducted an extensive review of
animal research related to Gulf War Veterans' symptoms. VA will be
discussing in its technical workgroup (see above) the results of the
animal studies and the ways in which these studies were evaluated and
used by the IOM committee in drawing their conclusions. The IOM
recommendations about possible future research concerning the validity
of animal models will also be considered by the TWG, but it would be
premature to make comments about specific IOM conclusions and
recommendations before the work of VA's TWG is complete.
Question 19: What is VA's opinion of the Research Advisory
Committee (RAC) on Gulf War Veterans' Illnesses (RAC)'s 2008 report,
which used animal studies to conclude that pyridostigmine bromide pills
and pesticide are associated with War Illness?
VA Response: In its 2008 report (http://www.va.gov/RAC- GWVI/docs/
Committee--Documents/GWIandHealthofGWVeterans--RAC- GWVIReport--
2008.pdf), the RAC on Gulf War Veterans' Illnesses concluded that there
was ``strong support for both PB [pyridostigmine bromide] and
pesticides as causal factors in Gulf War illness.'' (p. 185).
In its report, Gulf War and Health: Volume 8 (2010), (http://
www.nap.edu/catalog/12835/gulf-war-and-health-volume-8-update-of-
health-effects), IOM reviewed the publications cited by the RAC and
determined that there was ``insufficient support for the conclusion''
reached by the RAC (p. 279). The IOM indicated that there was a lack of
association in agricultural workers who used pesticides regularly, a
lack of persistent effects on the central nervous systems in animals,
and a lack of consistent results in studies of Gulf War Veterans.
VA's position, based on IOM's earlier reports (excluding Volume 10
published in 2016) is that the cause of Gulf War illness is not yet
known with certainty, even though groups of qualified scientists and
physicians have reviewed the same data, including animal studies.
Question 20: Please explain the reasons for the turnover in
leadership and membership of the RAC that has occurred since 2013. As
part of your response, please provide the background and qualifications
for each of the current committee members.
VA Response: This committee, required by section 104(b) of Public
Law 105-368 (1998), is, in addition to relevant VA policy, subject to
the Federal Advisory Committee Act (FACA), codified at 5 U.S.C. App.,
and regulations administered by the General Services Administration.
As a committee governed by the FACA, the RAC is required to follow
FACA guidelines and VA policy. The charter (http://www.va.gov/RAC-GWVI/
docs/Committee--Documents/CharterRACGWVI2015May.pdf) for the RAC
specifies that the Chair can be appointed for an initial 2-- year term
and may be reappointed for an additional 1 or 2-year term. Similarly,
the remaining members can be appointed for a 2 or 3 - year term and may
be reappointed for an additional 1 or 2 - year term. As of 2013, six
members had served since the committee was formed in 2002, three had
served since 2005, and one each had served since 2006, 2007, and 2008.
To become compliant with FACA and VA policy, approximately one-third of
the committee members were to be replaced in each of the next three
years. Membership rotations will continue each year into the future to
ensure that multiple viewpoints from scientists, physicians, and
Veterans are brought to VA. Nominations for membership are solicited in
the Federal Registry. Brief biographies of current members are
available on the RAC webpage (http://www.va.gov/RAC-GWVI/Members--and--
Consultants.asp).
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