A  white  paper  regarding  the  IOM  Gulf  War  Illness  (“Chronic  Multisymptom  Illness”/”CMI”)  panel.    Submitted  for  the  record  by  Anthony  Hardie.        

MEMO: Membership of Institute of Medicine Committee to Establish A Case Definition for “Chronic Multisymptom Illness” (“CMI”) in 1990-1991 Gulf War Veterans This memo reviews the membership of the recently-appointed IOM Gulf War case definition committee. (http://www8.nationalacademies.org/cp/CommitteeView.aspx?key=49546). It is followed by memos reviewing the previous IOM Gulf War committee (the 2013 treatment report committee) and the IOM Board on the Health of Select Populations, which oversees Gulf War reports. Membership on IOM committees related to Gulf War veterans’ health is heavily weighted toward positions favored by government officials in the 1990’s and early 2000’s, but now scientifically discredited, including the view that Gulf War multisymptom illness is due to stress or other pychiatric problems. A. Scientific Background to the Case Definition Committee In many cases, members have previous associations regarding views on this illness that they bring to the committee. As background, these respective views will be briefly summarized. These views fall into two broad categories: 1) views reflecting current science and 2) views reflecting positions from the 1990’s that have been discredited by current science. The current scientific understanding of Gulf War chronic multisymptom illness is reflected in the two recent comprehensive reports on the subject, the 2008 report of the Research Advisory Committee on Gulf War Veterans Illnesses (RACGWVI), and the 2010 Gulf War and Health (Vol. 8) report of the Institute of Medicine. In its 2008 report, “Gulf War Illness and the Health of Gulf War Veterans,” the RACGWVI found that Gulf War illness is real, that it affects at least one-fourth of US Gulf War veterans, that it is not the result of combat or other stressors (noting that rates of PTSD are low in Gulf War veterans), and that it is the result of toxic exposures during the war. http://www.va.gov/RAC-GWVI/docs/Committee_Documents/GWIandHealthofGWVeterans_RAC-GWVIReport_2008.pdf (pages 1-2). The 2010 IOM Gulf War and Health Report (Vol. 8), “Update of Health Effects of Serving in the Gulf War,” made similar findings, concluding that the illness (which it termed “chronic multisymptom illness”) is a “diagnostic entity,” affects more than 250,000 Gulf War veterans, is associated with service in the war, “cannot be reliably ascribed to any known psychiatric disorder,” and that “Gulf War illness likely results from an interplay of genetic and environmental factors.” The one significant difference is

that the IOM report did not find the evidence sufficient to conclude which specific environmental exposures caused the illness. http://books.nap.edu/openbook.php?record_id=12835 (pages 204, 262, 210, 109, 261) In the 1990’s and early 2000’s, the government theory of the illness reflected a combination of the following positions:

- These kinds of illnesses happen after every war. - Gulf War veterans have no common disease, just an unrelated assortment of

symptoms. - Their symptoms are psychiatric in origin, reflecting battlefield stress or other

psychological concerns. These views have been discredited through the scientific research assembled in the 2008 RACGWVI and 2010 IOM reports. B. Committee Membership The most striking characteristic of the group selected to be on this committee is how few qualify as experts in the disease. Case definitions are typically developed by committees of experts in the disease in question, using detailed data sources to ascertain objectively which elements best characterize the disease. The VA Gulf War Strategic Research Plan just released called for a case definition to be developed in this well-accepted fashion: “The case definition should be developed by a consensus panel of experts in the field, using analytical results from a comprehensive evaluation of available data resources.” http://www.research.va.gov/resources/pubs/docs/GWResearch-StrategicPlan.pdf (page 28) The original draft of the strategic plan, as it emerged from the scientific working groups and before its doctoring by VA staff, was even clearer on this point. Assigning this vital task, which will influence all future Gulf War health research, to a committee largely without expertise in the illness, and directing them to carry out the task through a literature review, is without precedent. The membership also does not appear to include anyone with prior experience in developing case definitions for other illnesses. 1. Only three members of the IOM committee appear to qualify as experts in the illness. Two of the three are associated with discredited viewpoints from the 1990’s and early 2000’s rather than current science.

• Dr. Howard Kipen, MD, has published and lectured on Gulf War Illness since the mid-1990’s, consistently supporting the views that all wars cause these kinds of health problems and that what caused the illness was not toxic exposures but the psychological fear of those exposures. Eg, “Reported exposures, stressors, and life events among Gulf War Registry Veterans, belief in CBW [chemical/biological warefare] exposure, and the experience of war stress and serious negative life events after the war, are important concomitants of Gulf War

illness.” Military Deployment as a Risk Factor for Psychiatric Illness Among Gulf War and Era Veterans.

o http://www.unc.edu/~ntbrewer/pubs/in%20press,%20fiedler,%20et%20al.pdf

o “The data we have don’t indicate there was anything about being exposed to a certain toxin that caused it. Those data say that just being there was enough.”http://www.umdnj.edu/umcweb/marketing_and_communications/publications/umdnj_magazine/hstate/sprsm98/gulf1.html

o “Concerns . . . of a unique Gulf War syndrome, remind us that military personnel returning from wars have regularly described disabling symptoms.” Clauw DJ, Engel CC, Aronowitz R, Jones DPhil E, Kipen HM, Kroenke K, Ratzan S, Sharpe M, WesselyS. Unexplained Symptoms after Terrorism and War: An Expert Consensus Statement. Journal of Occupational and Environmental Medicine 45(10):1040-8, 2003.

o Dr. Kipen was a reviewer of the 2005 IOM Gulf War (Vol. 3) report that found no association between selected environmental particulates, pollutants, and synthetic compounds and illnesses associated with Gulf War service. http://www.nap.edu/openbook.php?record_id=11180&page=R7

o Dr. Kipen was selected to present to, and review the report of, the 2006 IOM Gulf War (Vol. 4) committee whose main finding was that there is no unique Gulf War syndrome.

o http://www.iom.edu/Activities/Veterans/GulfWarLitReview/2005-APR-20/Gulf-War-and-Health--Review-of-the-Medical-Literature--Meeting-Two--Agenda.aspx

o http://www.nap.edu/openbook.php?record_id=11729&page=R7 o http://www.washingtonpost.com/wp-

dyn/content/article/2006/09/12/AR2006091201494.html

• Dr. Ron F. Teichman, MD, until recently worked at the VA New Jersey War Related Illness and Injury Study Center as deputy head of risk communication. His publications also support the views that the psychological worry about environmental exposures is the problem for ill veterans, not the exposures themselves, and that these experiences are common in wars. Eg, "OEF/OIF veterans reported a high level of environmental exposures and concerns about environmental exposures. Greater reported environmental exposures (β = 0.13) and environmental exposure concerns (β = 0.39) were associated with a greater somatic symptom burden.” Environmental Exposure and Health of Operation Enduring Freedom/Operation Iraqi Freedom Veterans.

o http://journals.lww.com/joem/Abstract/2012/06000/Environmental_Exposure_and_Health_of_Operation.3.aspx

o “Environmental exposure hazards during deployment to conflict are not new. Concerns about these exposures are not new.” Health hazards of exposures during deployment to war. J Occup Environ Med. 2012 Jun;54(6):655-8. doi: 10.1097/JOM.0b013e318259bfd9 http://www.ncbi.nlm.nih.gov/pubmed/22684316

• Suzanne Vernon, PhD, scientific director of the Chronic Fatigue and Immune

Disfunction Syyndrome Associatioin of America, has published recent research papers on altered immune function in ill Gulf War veterans, reflecting a more current understanding of the mechanisms underlying the illness. “GWI patients demonstrated impaired immune function as demonstrated by decreased NK cytotoxicity and altered gene expression associated with NK cell function.” Impaired immune function in Gulf War Illness. BMC Med Genomics. 2009; 2: 12.

o http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2657162/ Thus out of three members of the committee with direct expertise in the illness, two are proponents of the old views that the illness reflects the effect of psychological concern about environmental exposures rather than environmental exposures themselves, and that Gulf War veterans’ health problems are common to all wars. 2. Four members of the committee have served on other Gulf War-related panels, although they themselves are not experts in the field.

• Dr. Floyd Bloom, MD, has served on the Research Advisory Committee on Gulf War Veterans Illnesses, which produced the 2008 report reflecting the current scientific understanding of the illness.

• Dr. Deborah A. Cory-Slechta, PhD, served on the 2003 Gulf War and Health,

Vol. 2, report that found no association between pesticides and the illnesses affecting Gulf War veterans, although the 2003 Department of Defense study of pesticides used in the war concluded that “[i]t is likely that at least 41,000 servicemembers may have been overexposed to pesticides,” and that “[o]verexposures to pesticides, particularly organophosphates and carbamates, may have contributed to the unexplained illnesses reported by some Gulf War veterans.” http://www.gulflink.osd.mil/pest_final/index.html

• Dr. Cory-Slechta also served on the 2005 Gulf War and Health Vol. 3 report that

found no association between selected environmental particulates, pollutants, and synthetic compounds and illnesses associated with Gulf War service.

• Dr. Joanna Katzman, MD, just completed service on the 2013 IOM Gulf War

and Health Treatment report. Following a charge by VA to consider literature regarding all “populations with a similar constellation of symptoms,” the Treatment committee adopted a “working case definition” for chronic multisymptom illness that ignored the definition provided by Congress in the statute requiring the report, divorcing the definition from Gulf War service. Congress provided: “The term ‘chronic multisymptom illness in Persian Gulf War Veterans’ means a chronic multisymptom illness defined by a cluster of signs or symptoms related to service in the Persian Gulf War, typically including widespread pain, persistent memory and concentration problems, chronic

headaches, gastrointestinal problems, and other abnormalities not explained by well-established diagnoses.” Veterans Benefits Act of 2010, Sec. 805(e)(1), http://www7.nationalacademies.org/ocga/laws/PL111_275.asp The working case definition adopted by the Treatment report also contains no constraints as to whether the illness is psychiatric, despite the clear findings by the IOM and RACGWVI that it is not, resuscitating one of the discredited government theories.

The VA charge to the Case Definition committee similarly directs this new committee to consider literature in all “populations with a similar constellation of symptoms.” http://www8.nationalacademies.org/cp/projectview.aspx?key=49546 This charge spotlights the path that VA staff intend the Case Definition committee to take.

• Dr. Kenneth I. Shine, MD, is the chairman of the Case Definition committee. While he has not served on a prior IOM Gulf War committee, he was president of the IOM at the time the first Gulf War and Health report (Vol. 1) was conducted, which failed to find a connection between depleted uranium, sarin, pyridostigmine bromide, and vaccines and the health problems of Gulf War veterans. He personally led the news conference announcing its release. “’We would love to come up with remarkable new conclusions,'' Dr. Shine said, ''but after careful analysis, if the data isn't there, we can't draw any conclusions from it.'” http://www.nytimes.com/2000/09/08/us/study-fails-to-reveal-the-causes-of-gulf-war-syndrome.html The reason the data “isn’t there” is because animal studies were excluded from the committee’s scope of review as a result of a one-word change in the reviewing standards from those previously used by the IOM in its Agent Orange reports. Thus, the committee was only allowed to consider human studies, although most studies conducted on toxic substances are necessarily done in animals for ethical reasons. This slight of hand, which has resulted in findings of “insufficient evidence” in all subsequent Gulf War exposure studies, was first made in the Vol. 1 report. http://archives.veterans.house.gov/hearings/Testimony.aspx?TID=2125&Newsid=2169&Name= James H. Binns

In summary, of four committee members previously associated with other Gulf War reports, three of the four are associated with reports that failed to follow Congressional guidance and/or presented the view that toxic exposures are unrelated to Gulf War chronic multisymptom illness, despite evidence to the contrary that was not considered. 3. The remaining six members of the Case Definition committee appear to have no previous connection to Gulf War chronic multisymptom illness.

• Dr. Fred Friedberg, PhD, lists his research interests as chronic fatigue syndrome, unexplained chronic fatigue, illness self-management, cognitive-behavior therapy, fibromyalgia and EMDR. His publications reveal that he believes in a psychiatric approach to these types of conditions: “Using an individualized cognitive-behavioral approach the mental health clinician can offer

significant help to these ... patients.” Chronic fatigue syndrome, fibromyalgia, and related illnesses: a clinical model of assessment and intervention. J Clin Psychol. 2010 Jun;66(6):641-65. doi: 10.1002/jclp.20676. http://www.ncbi.nlm.nih.gov/pubmed/20186721

• Dr. James L. Levenson, MD, is described by his university website as “an

internationally acclaimed leader in the field of Psychosomatic Medicine.” http://www.vcu.edu/psych/education/fel-pm.shtml. He is past president of the Academy of Psychosomatic Medicine, author of “The American Psychiatric Publishing Textbook of Psychosomatic Medicine,” and a member of the editorial board of the journals Psychosomatics and Psychological Medicine. He was a member of the DSM-5 Work Group on Somatic Stress Disorders. http://www.vcu.edu/psych/faculty/faculty%20files/jlevenson.pdf

• Dr. Catherine Lomen-Hoerth, MD, PhD, is director of the ALS Center at

University of California, San Francisco.

• Dr. Thomas J. Mason, PhD, is professor of Environmental and Occupational Health at the University of South Florida. His primary work activities in recent years have been for the US military. http://health.usf.edu/NR/rdonlyres/89A4AA58-5DD2-4248-9F70-391E36C308D4/0/ThomasMason2013CV.pdf

• Dr. Linda Anh B. Nguyen, MD, is Clinical Assistant Professor of Medicine in

the Gastroenterology and Hepatology department of Stanford University.

• Dr. F. Javier Nieto, MD, PhD, is an epidemiologist and chair of the Department of Population Health Sciences, Univ. of Wisconsin. He lists among his main research interests "health consequences of sleep disorders and psychosocial stress." http://www.pophealth.wisc.edu/faculty/nieto

Thus, of the six members of the committee with no previous Gulf War health association, three are oriented respectively toward mental health treatment of related illnesses, psychosomatic medicine, and psychosocial stress. This emphasis on psychiatric orientations is particularly striking given the 2010 IOM Gulf War and Health report’s conclusion that "[t]he excess of unexplained medical symptoms reported by deployed Gulf war veterans cannot be reliably ascribed to any known psychiatric disorder." http://books.nap.edu/openbook.php?record_id=12835 Looking at the full membership, the IOM Case Definition report committee includes two Gulf War illness experts associated with discredited past government positions that the same thing happens after every war and that psychological fear of the exposures is the problem, three individuals who have served on previous IOM committees that failed to find an association between toxic exposures and health problems of Gulf War veterans, three individuals with no previous Gulf War association who are oriented toward

psychiatric views of similar conditions, and one individual associated with the Department of Defense. This totals nine of the thirteen members of the committee. The IOM staff director for the report is Carolyn Fulco. Ms. Fulco was the study director for Gulf War and Health, Vol.1, senior program officer for Gulf War and Health, Vol. 2, and senior program officer for Gulf War and Health, Vol. 3, none of which found associations between environmental exposures and Gulf War health effects as a result of the wording change that excluded animal studies from consideraton, and senior program officer for Gulf War and Health, Vol. 4, which found no unique Gulf War syndrome. The only major IOM Gulf War study that Ms. Fulco did not direct was the comprehensive 2010 IOM Gulf War and Health report (Vol. 8) that determined the illness was a diagnostic entity, associated with service in the war, not able to be reliably ascribed to psychiatric disorders, and likely the result of the interplay of genetic and environmental factors.

MEMO: Membership of the IOM Gulf War Treatment Committee (2013) 1. The Treatment Committee had fifteen members:

http://www.iom.edu/Activities/Veterans/GulfWarMultisymptom.aspx 2. Of the fifteen, four are particularly identified with somatic and psychosomatic illness (despite Gulf War Illness being neither psychological nor psychiatric):

• Dr. Francesca Dwamena is an internal medicine specialist and assistant professor of medicine and adjunct assistant professor of psychiatry at Michigan State. She has a Certificate in Psychosocial Medicine, is the director of Psychosocial Rounds, and has spoken on such subjects as "Treatment of Somatization in Primary Care" and "Medically Unexplained Symptoms and Physician Frustration." She has co-authored two papers with Dr. Joel Kupersmith, VA's chief research and development officer.

o http://www.healthteam.msu.edu/medicine/curriculum%20vitaes/Dwamena.pdf

• Dr. Frank de Gruy is a family physician and chairman of the department of

family medicine at the University of Colorado, Anschutz Campus. He lists his research interests as "mental disorders in the primary care setting" and "unexplained physical symptoms." He has co-authored eight papers with Dr. Kurt Kroenke, the VA doctor who was one of the five psychiatric-oriented speakers at the 2/29/12 IOM treatment committee meeting, e.g, "Multisomatoform disorder: an alternative to undifferentiated somatoform disorder in primary care.

o http://www.ucdenver.edu/academics/colleges/medicalschool/departments/familymed/about/faculty/Pages/FrankdeGruy.aspx

• Dr. Douglas Drossman is adjunct professor of gastroenterology and psychiatry at

the University of North Carolina. He is a past president of the American Psychosomatic Society, and has published on such topics as "Psychosocial Aspects of Inflammatory Bowel Disease" and "Teaching Psychosomatic (Biopsychosocial) Medicine in United States Medical Schools”

o http://www.med.unc.edu/ibs/files/cvs/DougDrossmanCV%2004-30-2010.pdf

• Dr. Javier I. Escobar is professor of psychiatry at the Robert Wood Johnson

Medical School. 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. He was a member of the task force that wrote DSM

o http://www.dsm5.org/MeetUs/Documents/Task%20Force%202012/Escobar-Disclosure-2012.pdf

o http://dxrevisionwatch.com/dsm-5-proposals/dsm-5-ssd-work-group/

• In addition, Dr. Kasisomayajula Viswanath, is a Ph.D. at the Harvard School of Public Health who specializes in health risk communication. "Risk communication" is a phrase often applied by government officials to the care of ill Gulf War veterans, suggesting, in effect, that doctors communicate to ill veterans that their health problems are not related to environmental exposures.

o http://www.viswanathlab.org/index.php/people/dr-k-qvishq-viswanath 3. Two other committee members are Ph.D. psychological professionals (though Gulf War Illness is neither psychological nor psychiatric):

• Dr. Lori Zoeller directs the Center for Anxiety and Traumatic Stress at the University of Washington. http://faculty.washington.edu/zoellner/people/zoellner.html

• Dr. Wayne Gordon is an associate professor of is a professor of rehabilitation medicine and associate professor of psychiatry at Mt. Sinai Hospital and specializes in traumatic brain injury research. http://www.mountsinai.org/profiles/wayne-a-gordon

4. The remaining eight members have a range of backgrounds:

• Dr. Bernard Rosof, the committee chairman, heads a consulting firm on medical quality http://www.qhcag.com/4.html

• Dr. Karen A. Robinson, epidemiologist, Johns Hopkins University; specializes in evidence-based medicine, health informatics. http://www.hopkinsmedicine.org/gim/faculty/robinson.html

• Dr. Isabel V. Hoverman, internal medicine specialist, private

practice http://www.healthgrades.com/physician/dr-isabel-hoverman-y323w • http://www.pwrnewmedia.com/2009/jointcommission91202/assets/Hoverman_bi

o.pdf • Dr. Elaine L. Larson, epidemiologist, Columbia University, infection control

and prevention http://www.mailman.columbia.edu/our-faculty/profile?uni=ell23 • Dr. Wayne Jonas, professor of family medicine, Georgetown University,

alternative medicine http://www.samueliinstitute.org/about-us/wayne-b-jonas-md

• Dr. Diana Cardenas, professor and chairman, Department of Rehabilitation Medicine, University of Miami, spinal chord injuries, management of chronic pain http://www.miamiproject.miami.edu/page.aspx?pid=329

• Dr. Joanne Kutzman is a neurologist with experience in treating fibromyalgia. http://hospitals.unm.edu/pain/clinicians/katzman_joanna.html

• Dr. Stephen Mitchell, rheumatologist, Georgetown University http://www.georgetownuniversityhospital.org/body_fw.cfm?id=8&action=detail&ref=2930

5. No one appears to have any expertise in treating or researching Gulf War illness, and only the last two members and Dr. Drossman appear to have direct experience with other multisymptom illnesses. Thus the only group with similar backgrounds with major representation on the committee was the four psychosomatic specialists, the risk communication expert, and the anxiety/traumatic stress psychologist. This emphasis on psychiatric views is striking giving the conclusion of the 2010 IOM report that this illness is not a psychiatric problem. The other background affiliation that stands out is that four of the treatment committee members had previously served on Gulf War health committees. Three served on previous IOM committees (Dr. Rosof, two; Dr. Drossman, three; Dr. Hoverman, four), and Dr. Larson served on the Clinton-era Presidential Advisory Committee on Gulf War Veterans Illnesses, which concluded that stress was the likely cause of GWI. Again, none of them have treated or studied ill Gulf War veterans. What they know about the problem comes from service on previous committees, and we have seen how IOM committees generally have been educated. Dr. Drossman, the past president of the American Psychosomatic Society, has been appointed to the last four IOM Gulf War committees, again for a biologically based condition that is neither psychiatric nor psychological. http://www.iom.edu/Global/Directory/Detail.aspx?id=0020010777

MEMO: Membership of the IOM Board on the Health of Select Populations The IOM board that handles military and veterans projects is the Board on the Health of Select Populations. Three members of the board were leading proponents of the government theory of Gulf War health issues in the 1990’s:

• Dr. Kurt Kroenke, one of the five psychiatric-oriented speakers who addressed the IOM treatment committee on Feb. 29, 2012, a close associate of two members of that committee, and a recognized figure in somatic medicine, was an Army doctor and active Gulf War psychiatric-oriented researcher in the 1990's.

• Dr. Francis Murphy. During the mid-to-late '90's, Dr. Murphy held the position at VA of "chief consultant" on occupational and environmental health, the position that Dr. Michael Peterson holds today. She was a leading spokesperson for the position that there is no Gulf War syndrome.

• Dr. Greg Gray. As a Navy doctor, Dr. Gray published 10+ papers between 1996-2001 that generally dismissed the idea that Gulf War veterans have any special health problems. They often appeared together as part of what Ross Perot called the “stress team.” For example, Murphy and Gray both addressed a 1998 IOM Committee formed to review Gulf War veterans' health care and research in response to a 1997 GAO report: http://www.gulflink.osd.mil/news/na_iomstudies_072398.html

There is no one on the board of the Health of Select Populations who represents current scientific understanding of Gulf War illness.