IOM Findings and VA Health Care Presentation to the Advisory Committee on Gulf War Veterans Craig Hyams, MD MPH Department of Veterans Affairs Office of Public Health and Environmental Hazards

2 National Academy of Sciences (NAS), Institute of Medicine (IOM) US government agencies regularly seek the NAS/IOM’s scientific advice on a broad range of health-policy issues. IOM studies are conducted by independent committees of volunteer scientists: composed of leading internationally-recognized experts. selected by the IOM based on their expertise, good judgment and freedom from conflict of interests.

3 National Academy of Sciences (NAS), Institute of Medicine (IOM) IOM requires that a committee’s formal findings and recommendations are evidence-based whenever possible and noted as only expert opinion when that is not possible. Each IOM report undergoes extensive, internal and peer review by a group of external experts.

4 IOM & Deployment Health Questions IOM studies are particularly useful for evaluating the health of combat veterans because of research limitations. Research studies often fail to link specific deployment- related environmental hazards to unique health outcomes because of the lack of accurate exposure and troop location data during chaotic wartime conditions – combat deployments are not large epidemiological studies.

5 IOM & Deployment Health Questions Developing equitable health care and assistance policies for combat veterans related to environmental hazards therefore cannot be totally reliant on perfect science and frequently cannot be based on research studies of the exposed veterans themselves.

6 IOM & Deployment Health Questions Consequently, the development of health care and disability policies for combat veterans has had to rely to some extent on thorough reviews of all relevant scientific literature related to non- deployed and civilian populations with similar but well-characterized exposures by independent scientific groups such as IOM.

7 Prior Studies IOM conducted approximately 20 studies of Gulf War health issues from 1994 to 2000 Short list of other independent reviews: –Defense Science Board, 1994 –NIH Technology Assessment Conference, 1994 –VA Advisory Committee in 1990’s, no official report –Presidential Advisory Committee, final report in 1997 –United States Senate, Committee on Veterans' Affairs, Report of the Special Investigation Unit on Gulf War illnesses –VA Research Advisory Committee on Gulf War Veterans Illnesses –Numerous committees and boards in UK, Canada, and Australia

8 Current IOM Studies since 2000 Evaluation of 1991 Gulf War-related health effects: In response to veterans’ health concerns, Congress and the President enacted two laws, Public Laws and , which were modeled after Agent Orange Act of Under this legislation, VA was directed to ask the IOM to evaluate the scientific literature regarding associations between illness and exposures to potential health hazards related to Gulf War service. The two laws specified thirty-three possible Gulf War-related environmental, occupational, and pharmaceutical hazards.

9 List of Recent IOM Studies 1.“Gulf War and Health: Volume 1. Depleted Uranium, Sarin, Pyridostigmine Bromide, Vaccines.” 2000; 2.“Gulf War and Health: Volume 2. Insecticides and Solvents.” 2003; 3. “Gulf War and Health: Updated Literature Review of Sarin.” 2004; 4.“Gulf War and Health: Volume 3. Fuels, Combustion Products, and Propellants.” 2005;

10 List of Recent IOM Studies (2) 5.“Gulf War and Health: Volume 4. Health Effects of Serving in the Gulf War.” 2006; 6.“Gulf War and Health: Volume 5. Infectious Diseases.” 2007; 7.“Gulf War and Health: Volume 6. Physiologic, Psychologic, and Psychosocial Effects of Deployment-Related Stress.” 2008; 8. Gulf War and Health: Updated Literature Review of Depleted Uranium. 2008;

11 Directed Studies Utilized by IOM Annual Report to Congress: Federally Sponsored Research on Gulf War Veterans’ Illnesses for Department of Veterans Affairs “ From FY 1992 through FY 2007 the Departments of Veterans Affairs (VA), Defense (DoD), and Health and Human Services (HHS) funded 345 distinct projects related to health problems affecting GW veterans. The scope of the Federal research portfolio is broad, from small pilot studies to large-scale epidemiology studies involving large populations and major center-based research programs. Federal funding for research on GWVI totaled $267 million for the period from FY 1998 through FY As of September 30, 2007, 272 projects (79 percent of the 345 projects) were completed, and 73 projects (21 percent) were new or ongoing.”

12 Major IOM findings Many of IOM committee findings about potential long-term health effects apply to situations involving an unusually large exposure sufficient to cause immediate and serious health effects. For the types of low-dose and short-term exposures thought to characterize the experience of most Gulf War I veterans, no definite associations were found between health problems and exposures to DU, PB, chemical warfare agents, insecticides, solvents, combustion products, air and occupational pollutants, and vaccines.

13 Major IOM findings Associations were found between deployment to SW Asia and certain infectious diseases, including: – malaria; Mycobacterium tuberculosis – chronic effects of brucellosis, Coxiella burnettii, and West Nile virus – reactive arthritis from enteric infections – visceral leishmaniasis.

14 Major IOM findings For 2006 report, Gulf War & Health Vol. 4: Health Effects of Serving in the Gulf War, the expert committee identified over 4,000 potentially relevant scientific reports and focused on 850 epidemiological studies. They concluded: “VA and DoD have expended enormous effort and resources in attempts to address the numerous health issues related to the Gulf War veterans. The information obtained from those efforts, however, has not been sufficient to determine conclusively the origins, extent, and potential long-term implications of health problems potentially associated with veterans’ participation in the Gulf War.”

15 Major IOM findings Conclusions (continued) “… the results of that research indicate that although deployed veterans report more symptoms and more severe symptoms than their non-deployed counterparts, there is not a unique symptom complex (or syndrome) in deployed Gulf war veterans.”

16 Lessons for Clinical Care The IOM has not identified a new syndrome among veterans of the 1991 Gulf War. Systematic clinical registry examinations of over 100,000 Gulf War veterans conducted in the USA by VA and DoD, and in the UK, Canada, and Australia have identified a wide range of medical and psychological health problems among this adult cohort of combat veterans. To provide good clinical care of Gulf War veterans, each veteran has had to be evaluated individually with thorough assessment of the veteran’s unique health problems and treatment tailored to the needs of the individual veteran.

17 Use in Disability Determination IOM provides formal reports to VA Secretary. A Working Group is established by VA from diverse offices that reviews the IOM report and prepares a summary of its assessment and a statement of recommendations or options. A Task Force is then convened, composed of the Under Secretary for Health, the Under Secretary for Benefits, General Counsel, and the Assistant Secretary for Policy and Planning. The Task Force reviews the IOM report and summary prepared by the Working Group and develops recommendations for the Secretary.

18 Use in Disability Determination Lastly, the Secretary decides if a presumptive service connection is warranted based on a determination that there is a “positive association” between exposure in question and development of disease.

19 Numerous independent review groups have evaluated Gulf War health issues over the last 17 years. Substantial research of Gulf War health questions has been conducted. Much greater research and review is needed to determine the causes and optimal treatments for health problems experienced by Gulf War veterans, particularly for unexplained symptoms. Of note, the legally mandated NAS studies of Gulf War health questions will sunset in Summary:

20 Overall, the mandated IOM “Gulf War & Health” reviews have been helpful to VA and veterans by providing an independent and scientifically credible basis for establishing whether or not specific illnesses are associated with the types of environmental and occupational exposures experienced by most veterans of the 1991 Gulf War. Current research, clinical examinations, and IOM findings indicate that 1991 Gulf War veterans are suffering from a wide range of medical and psychological illnesses. Summary (2)