SUSAN H. MATHER, MD, MPH
DEPARTMENT OF VETERANS AFFAIRS
SUBCOMMITTEE ON HUMAN RESOURCES
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
HOUSE OF REPRESENTATIVES
May 14, 1998
Mr. Chairman and Members of the Subcommittee:
We are pleased to be here today to represent the Department of Veterans Affairs (VA) Gulf War veterans program. You requested that we provide testimony on the General Accounting Office report "GULF WAR VETERANS: Incidence of Tumors Cannot Be Reliably Determined From Available Data." The Subcommittee requested this report because of Gulf War veterans’ concerns that they may be at higher risk of neoplasms as a consequence of their service in the Gulf War.
TREATMENT OF AND RESEARCH ON GULF WAR VETERANS’ ILLNESSES
Mr. Chairman, as you are aware, VA has testified before the Subcommittee at seven previous hearings—most recently on February 24, 1998---and we have provided information on our Gulf War health care and research efforts on those occasions. Specifically, at those hearings we have provided updates on VA's Gulf War veterans’ health care, research, education, outreach, and benefits programs. Therefore, while I will provide some background information, I refer you to our previous testimony for a more detailed discussion of VA’s Gulf War programs and to the Annual Report to Congress for Federally Sponsored Research on Gulf War Veterans’ Illnesses, which was released on April 22, 1998.
The Department of Veterans Affairs began planning to provide health care and benefits to the service members deployed to Operations Desert Shield and Desert Storm as soon as the first soldiers entered the theater of operations. VA's Gulf Registry Health Examination Program was the first component of VA's comprehensive Gulf War response. VA developed the Registry in 1991, and Congress passed authorizing legislation in 1992. The Gulf War Registry was established primarily to assist Gulf War veterans to gain entry into the continuum of VA health care services by providing them with a free, complete physical examination with basic laboratory studies and to act as a health screening database. VA staff are instructed to encourage all Gulf War veterans, symptomatic or not, to get a Registry examination. The Registry's database not only allows VA to communicate with Gulf War veterans via periodic newsletters, but also provides a mechanism to catalogue possible exposures and prominent symptoms and to report diagnoses present at the time of the examination. This record of symptoms, diagnoses and exposures makes the Registry valuable for health surveillance purposes; however, the voluntary, self-selected nature of the database means that the experiences, illnesses and health profiles of those in the Registry cannot be generalized to represent those of all Gulf War veterans.
Since the Registry examination program was initiated, VA's Gulf War programs have grown to encompass a comprehensive approach to health services, addressing relevant medical care, research, outreach and educational issues. In 1993, at the request of VA, Congress passed legislation later enacted as Public Law 103-210, giving Gulf War veterans special eligibility (priority) for VA health care. This law gave VA the authority to treat Gulf War veterans who have disabilities that may have resulted from exposure to a toxic substance or environmental hazard during Gulf War service. We are also pleased that Congress passed legislation subsequently enacted as Public Law 105-114, which expands Gulf War veterans' eligibility for health care for any disability that might be associated with service in the Gulf War. VA now provides Gulf War Registry health examinations and hospital and outpatient follow-up care at its medical facilities nationwide, specialized evaluations at four regional Referral Centers, and readjustment and sexual trauma counseling at Vet Centers and VA medical facilities nationwide to Gulf War veterans. To date, almost 67,000 Gulf War veterans have completed Registry examinations; almost 2.7 million ambulatory care visits have been provided to 226,530 Desert Shield/ Desert Storm Conflict veterans; more than 23,000 Gulf War veterans have been hospitalized at VA medical facilities; there have been almost 500 admissions to specialized Referral Centers; and more than 83,000 Gulf War veterans have been counseled at VA's Vet Centers. VA is committed to continue to provide, and improve, health care services available to Gulf veterans.
IOM Workshop on Assessment of Health Outcomes and Treatment Effectiveness
Concerns have been raised about the government’s ability to track the health of Gulf War veterans. As a result, VA and the Department of Defense (DoD) have contracted with the National Academy of Sciences, Institute of Medicine (IOM), to provide advice on the optimal methods to assess the health status of Gulf War veterans and the effectiveness of treatments being delivered by the Department. On May 7, the IOM held a workshop in Washington, and IOM will next produce an interim report.
Status of Gulf War Veterans Research
In order to get the best assessment of the health status of Gulf War veterans, a carefully designed and well-executed research program is necessary. VA, as presidentially-designated coordinator for Federally sponsored Gulf War research, has laid the foundation for such a program. Under the auspices of the Persian Gulf Veterans Coordinating Board Research Working Group, VA, DoD and the Department of Health and Human Services have developed a structured research portfolio to address the currently recognized, highest priority medical and scientific issues. 121 Federally sponsored research projects are pending, underway or have been completed. More than half of these projects are being carried out by non-Federal investigators. Thirty-nine of the 121 projects are completed. Seventy-eight projects are ongoing, and four have been awarded funds but are pending start-up.
Federally funded researchers have, to date, published approximately 60 papers in the peer-reviewed literature, including nearly 40 from VA investigators alone. VA’s own research programs related to illnesses of Gulf War veterans include more than 40 research projects, amounting to a cumulative expenditure of research dollars projected from FY 1994 through FY 1998 of approximately $27 million. The research portfolio of VA encompasses a variety of research approaches, including epidemiology, basic research, clinical research, and applied research, applied to a vast array of potential exposures and health outcomes. In addition, VA research is embarking on some important steps toward the assessment of effective treatments for Gulf War veterans’ illnesses.
I am pleased to report that there has been significant progress on a number of key VA research studies. The VA Office of Research and Development has awarded funding for Phase III of the National Health Survey of Gulf War Veterans, and preliminary site selection has begun. It is expected that physical examinations will begin in the near future. As you may recall, the National Survey is designed to determine the prevalence of symptoms and illnesses among a random sampling of Gulf War veterans across the nation. The Survey is being conducted in three phases. Phase I was a population-based mail survey of the health of 30,000 randomly selected veterans from the Gulf War era (15,000 Gulf War veterans and 15,000 non-Gulf War veterans, males and females). The data collection phase is complete and analysis of the data continues. Phase II consisted of a telephone interview of 8,000 non-respondents from Phase I (4,000 deployed and 4,000 non-deployed veterans) to assess any response differences between respondents and non-respondents to the mail survey. Additionally in Phase II, 2,000 veterans from each of the deployed and non-deployed groups (1,500 mail respondents and 500 telephone interview respondents) will be selected to validate their health questionnaire responses (mail or telephone) against their medical records. Phase II is nearing completion. In Phase III, 2,000 veterans who responded to the postal survey or underwent a telephone interview will be invited, along with their family members, to participate in a comprehensive physical examination protocol. These examinations will be conducted at 17 VA medical centers nationwide and involve specialized examinations, including neurological, rheumatological, psychological, and pulmonary evaluations. Completion of data collection is anticipated in late-1999. This study will provide the most comprehensive picture of the prevalence of symptoms and illnesses among veterans who served in the Gulf War.
With respect to mortality, VA’s Environmental Epidemiology Service has carried out a mortality study of all Desert Shield and Desert Storm veterans and a comparison group of military service members who were not deployed to the Gulf War. The results of the study through September 1993 and a follow-up through December 1995 did not reveal an increased mortality risk of medical conditions, including neoplasms in Gulf War veterans. With respect to cancer, this result is not surprising since most cancer has a long latency for development after exposure to carcinogens. VA will continue to update this data on five-year intervals. This is a valid mechanism to provide surveillance for development of serious, life-threatening cancers in veterans. I would note that the mortality study did find elevated rates of death from external causes (primarily accidents) in Gulf War veterans as compared to the non-deployed control group.
Two other studies of interest to the Committee are in the planning stages. The VA Office of Research and Development is developing a multi-site, randomized clinical trial to assess the effectiveness of treatments for Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM) in Gulf War veterans. Such a study is now possible because these conditions have case definitions along with proposed treatments. A second treatment trial is under development that will examine the effectiveness of antibiotic treatment in ill Gulf War veterans. These studies will be carried out in collaboration with DoD and conducted at multiple VA and DoD health care facilities. Each department is investing up to $5 million to conduct these trials. Additionally, because of its experience and research on the characteristics of these diseases, we are consulting with the National Institutes of Health (NIH), the University community, and international experts in the development of these research protocols.
In addition, the VA Office of Research and Development has issued a Program Announcement, or general invitation to VA clinicians/scientists, to propose additional multi-site trials to evaluate the effectiveness of treatment strategies for other symptom based conditions. The planned treatment trial, along with any trials proposed in response to the Program Announcement, will undergo rigorous scientific peer review by VA’s Federally chartered Cooperative Studies Evaluation Committee. These treatment trials are in response to the mandate in Public Law 105-114 to establish demonstration projects to test new approaches to treating and improving satisfaction with treatment of Gulf War veterans who suffer from undiagnosed and ill-defined disabilities.
The Department has received and reviewed the GAO’s report "GULF WAR VETERANS: Incidence of Tumors Cannot Be Reliably Determined From Available Data". The report discusses the strengths and weakness of the available data for assessing neoplasms among Gulf War veterans. GAO concludes that no direct link has been established between potential exposures and development of tumors among Gulf War veterans. GAO raises concerns that many of the potential hazardous exposures of these veterans are potentially carcinogenic. GAO states that existing data sources provide limited information about the incidence of tumors or other illnesses among Gulf War veterans and recommends that the Secretaries of Veterans Affairs and Defense continue to develop comparable databases and strengthen existing data systems. Finally, GAO points out neither Federal nor civilian medical data sources currently provide adequate information on the health conditions of Gulf War veterans to allow a reliable estimate of the incidence of tumors. We concur.
VA also agrees with GAO’s conclusion that cancer incidence among Gulf War veterans cannot be determined using existing federal, state, or private data sources. As was discussed in our previous testimony before this Committee on June 25, 1996, these data sources have important limitations that preclude drawing scientifically valid inferences about the risk of developing a neoplasm among Persian Gulf veterans. First, Gulf War veterans have been authorized special eligibility for both inpatient and outpatient treatment at VA medical facilities. The same special eligibility is not authorized for other Gulf War era veterans who did not serve in the Gulf, making comparisons between the two populations difficult. Second, many Gulf War veterans are identified as having neoplasms in the PGW Registry health examination program database. No similar database exists for other Gulf era veterans. Both of the above factors introduce a selection bias that makes comparison of the rates of neoplasms in these two groups invalid. Furthermore, incidence of cancer cannot be determined because VA and DoD databases do not account for individuals who sought care from non-federal medical facilities.
VA agrees with the GAO recommendation that data sources and information systems should be strengthened. The Department has taken several actions to improve its information technology and management. As noted in the GAO report, for the first time in FY 1997 outpatient diagnostic information was reported in the ambulatory care database. In FY 1998, VA initiated a Gulf War Veterans’ Information System to compile timely and consistent data on Gulf War veterans from VHA and VBA data sources. In addition, VA and DoD have begun development of a joint computerized patient record that will enable seamless record transfer between the two Departments. VA is committed to continue improvement of its information systems into the next century.
While we are confident that these information technology and management initiatives will improve our ability to assess the medical condition of individuals who use Federal health care, they will not allow us to accurately assess the incidence of non-fatal cancers in Gulf War or other Gulf Era veterans. Deficiencies in the data sources are neither limited to nor unique to VA or DOD. Cancer registries and reporting in the civilian medical community are incomplete as well. The best U.S. cancer incidence data (new cases of cancer per year) comes from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program. This uses 13 population based cancer registries (Atlanta, Detroit, Seattle/Puget Sound, Oakland/San Francisco, Connecticut, Iowa, New Mexico, Utah, Hawaii, Rural Georgia, Arizona, Los Angeles, and San Jose/Monterey) generally thought to be the best in the nation. SEER data cover approximately 14% of the U.S. population. We note that, beyond SEER, a U.S. National Cancer Registry has merit for many reasons, as does a VA Cancer Registry. With respect to the latter, Under Secretary for Health, Kenneth W. Kizer is committed to the Department’s developing such an effort.
Improvements in future data sources will enhance our ability to assess the health status of Gulf War veterans. However, it is our opinion that well-designed and well-executed epidemiologic studies will be necessary to supplement these efforts and give us a complete assessment of Gulf War veterans’ health. VA is committed to pursuing these avenues.
Mr. Chairman, that concludes my prepared statement. My colleagues and I will now be happy to respond to any questions Committee members may have.
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Reviewed/Updated Date: November 10, 2009