November 16, 1999

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Mr. Chairman and members of the Subcommittees, I appreciate the opportunity to appear before you to discuss the possible health effects of the drug pyridostigmine bromide (PB) on veterans who served in the Gulf War.

As you know, U.S. service members may have been exposed to a variety of hazardous materials during the Gulf War. Veterans, their families, and the VA have been concerned about possible health effects from exposure to the drug PB, as well as to other agents including depleted uranium, oil-well-fire smoke, vaccines, pesticides, chemical and biological warfare agents, and psychological and physiological stress. Numerous independent reviews have looked at the existing medical and scientific literature to determine what is known about health effects from these exposures. The findings have suggested that there is no single unique syndrome that explains the symptoms and illnesses of all Gulf War veterans and that some exposures are unlikely to cause health effects. Based on the findings and recommendations of these reviews, the Federal government has funded a range of significant research programs to investigate areas that are less well understood. Nevertheless, in its ongoing efforts to address Gulf War veterans’ health problems, VA has not ruled out any of these exposures as possible causes of Gulf War veterans’ illnesses.

This Nation has made a serious commitment to protect the health of, and to care for, military service members and veterans. VA has supported this commitment by establishing health care programs, compensation and benefits programs, and a national research agenda that is focused on the health needs of Gulf War veterans. VA, DOD, and HHS have spent about $134 million over the last six years on 145 federal research projects that are directly related to Gulf War veterans’ health issues. The coordination of this research is the primary responsibility of the Interagency Research Working Group, under the auspices of the Persian Gulf Veterans Coordinating Board.

PB is an FDA-approved treatment for the chronic muscle disorder myasthenia gravis and has been used for that purpose for over 40 years. PB was used as an unapproved, investigational drug during the Gulf War as a pre-treatment to reduce the toxicity of the chemical warfare nerve agent soman. Several external independent scientific committees have reviewed the medical and scientific literature on Gulf War health exposures and have not ruled out the possibility of long-term health effects from taking this drug. These reviews, conducted by teams of scientists, physicians, public health specialists, veterans and others, include the 1994 "NIH Technology Assessment Workshop"; the 1996 Institute of Medicine, "Report of the Committee to Review the Health Consequences of Service During the Persian Gulf War"; the 1996 "Presidential Advisory Committee on Gulf War Veterans’ Illnesses"; and independent scientific reviews contracted by the Committee on Veterans’ Affairs, U.S. Senate, reported in its 1998 "Report of the Special Investigation Unit on Gulf War Illnesses".

Based on these reviews and other information, there is insufficient evidence to conclude that the health effects experienced by Gulf War veterans today are related to exposure to PB during the Gulf War. However, additional research is needed to answer specific outstanding questions about the long-term effects of PB, either PB exposure alone or in combination with exposure to other risk factors, such as pesticides.

Based upon these recommendations, which predate the recent RAND report, the Interagency Research Working Group solicited and funded a number of research studies on potential health effects of PB. Twenty-six such studies have been funded with a total estimated cost of approximately $20 million. Five of the studies have been completed and 21 are ongoing.

The RAND report declared that its conclusion that PB cannot be excluded as a contributor to illnesses in Gulf War veterans differs from conclusions of some prior investigating bodies, such as the Presidential Advisory Committee and the Institute of Medicine. We think that this statement overstates the differences. The other investigating bodies have not ruled out PB as a possible cause of or contributor to the illnesses that some Gulf War veterans are reporting. The RAND report differs in some important ways from the previously described, independent scientific and medical literature reviews. But, in the most critical aspects, the reports are similar. All of them concluded that further research on possible health effects from PB is warranted. The earlier reviews were focused on whether scientific evidence existed that suggested PB was likely to be associated with health problems, while the recent RAND review focused on whether PB could be excluded as a possible cause of health problems.

As you know, the RAND author discussed seven hypotheses relating to how a brief exposure to PB during the Gulf War might affect the health of Gulf War veterans today. We are fortunate that all of those hypotheses were also considered by the prior reviews. In fact, each of the seven hypotheses is currently being addressed by one or more of the 26 Federally sponsored research studies. The following table lists the seven hypotheses raised by the RAND investigator and the number of studies that address each. Some studies address more than one hypothesis.

The RAND report is only the latest in an ongoing, intensive effort to improve our understanding of Gulf War health issues. In this regard, VA has contracted with the Institute of Medicine (IOM) for a new study entitled "Health Effects Associated with Exposures Experienced During the Persian Gulf War". This ongoing effort will provide a comprehensive review and analysis of the scientific and medical literature on health effects associated with known Gulf War exposures. VA contracted for this study in June 1998 and thereafter Congress supported this effort with legislative mandates in P.L. 105-368 and P.L. 105-277.

The first phase of the IOM study will include a complete review of scientific literature related to health effects associated with exposure to depleted uranium, vaccines, organophosphate chemical warfare nerve agents, and PB. This report is scheduled to be completed in August 2000.

To summarize, since 1992 VA has implemented a comprehensive, coordinated set of programs to address Gulf War veterans’ health problems. In doing so, we have objectively assessed the available published scientific and operational information concerning exposures during Gulf War service and sought the advice of numerous experts. Clearly, in examining the scientific literature, it is important to keep an open mind and consider all information. However, that should not be equated to giving the same weight to subjective and anecdotal reports as to scientifically designed, replicated research results. American veterans served honorably in the Gulf War and deserve the best health care and research program addressing their health problems that the Nation can provide. VA is committed to providing quality health care and compensation for service-connected disabilities and continuing to aggressively pursue answers to the health concerns of Gulf War veterans and their families.