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RAND RELEASES NEW STUDY IN GULF WAR ILLNESS SERIES
FINDS DRUG "CANNOT BE EXCLUDED" AS CONTRIBUTOR

     This executive summary reproduces the preface and summary from Pyridostigmine Bromide by Beatrice Alexandra Golomb, MR-1018/2-OSD, 1999, 424 pp., $30.00, ISBN:0-8330-2677-1, available from RAND Distribution Services (telephone toll free 877-584-8642; fax: 310-451-6915; or Internet: at RAND's home page, link on this page.) The full report includes all references and may be viewed on the World Wide Web, link on this page.

PREFACE

     This literature review, one of eight commissioned by the Special Assistant to the Deputy Secretary of Defense for Gulf War Illnesses, summarizes the existing scientific literature on the health effects of pyridostigmine bromide that may have affected service members who served in Operations Desert Shield and Desert Storm. The eight RAND reviews are intended to compliment efforts by the Defense Department and other federal agencies as they attempt to understand the full range of health implications of service in that conflict.
     While many veterans have reported an array of physical and mental health complaints since the war, it is not yet clear the extent to which the veterans are experiencing either higher-than-expected rates of identifiable illnesses with known etiologies or any other illnesses from as yet unidentified origins.
     The other seven RAND literature reviews deal with chemical and biological warfare agents, depleted uranium, pesticides, oil well fires, immunizations, infectious diseases, and stress. The topics of these reviews all represent plausible causes of some of the illnesses Gulf War veterans have reported.
     These views are intended principally to summarize the scientific literature on the known health effects of given exposures to these risk factors. Where available evidence permits, the reviews also summarize what is known about the range of actual exposures in the Gulf and assess the plausibility of the risk factor at hand as a cause of illnesses. Statements related to the Gulf War experience should be regarded as suggestive rather than definitive, for much more research both on health effects and exposures remains to be completed before more definitive statements are made. Recommendations for additional research where appropriate are also made.
     These reviews are limited to literature published or accepted for publication in peer-reviewed journals, books, government publications, and conference proceedings. Unpublished information was occasionally used, but only to develop hypotheses.
     This work is sponsored by the Office of the Special Assistant and was carried out jointly by RAND Health's Center for Military Health Policy Research and the Forces and Resources Policy Center for the National Defense Research Institute. The latter is a federally funded research and development center sponsored by the Office of the Secretary of Defense, the Joint Staff, the unified commands, and the defense agencies.

SUMMARY

     Pyridostigmine bromide (P.B) is a drug, often given as a tablet, that has been approved since 1955 by the US Food and Drug Administration for treatment of myasthenia gravis, a disease characterized by weakness and fatigability of the muscles. During the Persian Gulf War (PGW) P.B was used as an "investigational new drug"(IND) by the US military and some other allied forces as a pretreatment adjunct to protect military personnel from death in event of attack with the nerve agent soman. (IND status conferred by the FDA does not permit unrestricted use but may, as in this case, have conditions attached.) P.B is called a pretreatment adjunct because it is given before exposure to be effective. Also, it is not effective alone but only confers benefit if post exposure treatments are given as well.
     P.B is used primarily to protect troops against attack by one particular nerve agent, soman. During the PGW, Iraq was known to have nerve agents, including sarin, and had weaponized them by putting them into rockets, bombs, and missile warheads. While it is not known whether Iraq had militarized the nerve agent soman, it was known that the former Soviet Union had soman, and there were concerns, particularly since the fragmentation of the former Soviet Union, that Iraq may have purchased the soman. Iraq used chemical weapons against Iran and the Kurds. Because of the possibility that Iraq had soman, coalition troops were provided with P.B, to be used for protection when the threat of chemical warfare was deemed high. evidence from that time and subsequent to the PGW suggests that Iraq had weaponized the nerve agents sarin, cyclosarin, and perhaps Tabun and VX, but no evidence uncovered suggests that they had soman or had weaponized it.
     This report examines issues surrounding the safety and to as lesser degree the effectiveness of P.B. The sections on safety consider seven hypotheses of how P.B might lead to negative health effects. Each hypothesis is investigated to determine of or can be rejected as a possible causal factor. If sufficient evidence cannot be marshaled to rule out a hypothesis, this does not imply that it is necessarily a causal factor, only that the possibility cannot be dismissed.

LINK TO: PYRIDOSTIGMINE BROMIDE REPORT INDEX

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