Submitted For the Record by William T. Frasure Deputy Director Government Relations Department Before the House Veterans Affairs Subcommittee on Health and Oversight & Investigations Regarding Pyridostigmine Bromide (PB) And Its Health Effects On Gulf War Veterans. November 16, 1999 Vietnam Veterans of America appreciates this opportunity to present our views regarding pyridostigmine bromide (PB) and its health effects on Gulf War veterans. Pyridostigmine Bromide was essentially an experimental drug administered to approximately 250,000 U.S. troops during the Gulf War to counter the chemical agent soman. In light of the hard intelligence that DoD had in August of 1990 indicating that Iraq had in its possession soman, sarin, cyclosarin, mustard gas, and other chemical agents, the administration of PB pills was certainly a reasonable measure of protection at the time. VVA wants to make it clear that we are not focusing on DoD’s decision to administer the PB pills. VVA’s concerns center on the possible long term adverse health effects stemming from PB, and the care provided to Gulf War veterans experiencing PB related symptoms by the Department of Veterans Affairs. In December of 1990, DoD requested a waiver of informed consent from the Food and Drug Administration (FDA) granting the military the legal authority to administer PB. One of the conditions of the FDA waiver was that the military had a responsibility to keep records regarding the administration of the PB pills and to determine the long term effects of PB. Up until very recently, DoD has maintained that PB is not a causal factor for Gulf War undiagnosed illnesses. Since 1991, when thousands of Gulf War veterans first started exhibiting similar, undiagnosed conditions, DoD has, in fact, possessed information that clearly shows that PB pills cannot be ruled out as a causal factor. Recently, Dr.Galomb of the RAND Corporation (hired by the Pentagon to study various aspects of Gulf War undiagnosed illnesses to include PB) stated that the PB: …issue is a complex one, involving trading off uncertain health risks-but risks now shown to be biologically plausible-against uncertain gains from use of PB in the warfare setting [xxxiii]. Dr.Galomb further states that: …there remain some concerns regarding the efficacy of PB in protection against nerve agent threats. For some nerve agents, such as sarin, evidence was not adequate to exclude a possible harmful effect by use of PB as a pretreatment [277]. There is varied scientific evidence from different studies, both government and non-government, showing that PB makes individuals more vulnerable to other nerve agents, such as VX and Sarin. These agents were released into the air during demolitions of Iraqi munitions bunkers on March 4 and March 10, 1991. (Many other demolitions remain under DoD investigation.) It has also been shown that PB, when taken by a person who is exposed to insect repellant and insecticides, creates a harmful, debilitating effect on the person’s immune system In 1996, a Duke University study stated that: an anti-nerve gas (PB) pill taken by many of the troops may have interfered with the body’s natural defenses against the toxic effects of an insecticide and an insect repellant they routinely used to protect against disease carrying flies and mosquitoes. Also in 1996, both the Institute of Medicine (of the National Academy of Science) and the Presidential Advisory Committee on Gulf War Veterans’ Illnesses concluded that further research is needed in regards to the synergistic effects of PB and other risk factors and agents. It is now known that DoD did not keep records documenting who took PB and other relevant variables (amount, etc.) despite their clear obligation to do so. A RAND Corporation report has stated that: The DoD Gulf War experience in the use of PB (pills)…was characterized by poor record keeping, inadequate data collection, and other violations of the terms agreed to in the FDA waivers. VVA strongly urges Congress to fund additional research regarding the synergistic effects of PB and other toxins must begin now. Research clearly shows that a connection between PB and Gulf War illnesses is likely. Furthermore, VVA urges the Congress to hold hearings regarding VA’s role in granting direct service connection for conditions associated with the ingestion of PB. Public Law 105-277, the "Persian Gulf War Veterans Act of 1998" has paved the way for the VA to establish direct service connection for conditions associated with PB and a myriad of other toxins and exposures associated with Gulf War undiagnosed illnesses. VVA urges Congress to note that once PB research was funded, adverse effects of the drug were found. We believe there should be additional research on the possible long term adverse effects of the anthrax vaccine, oil well fire particulate matter, Depleted Uranium, and other known toxins present in the Gulf War theater. VVA finds it troubling that DoD failed to accurately gather data regarding the administration of PB to its troops. We ask these fundamental questions that have yet to be answered: Why did DoD ignore the claims made by thousands of Gulf War veterans and scientists regarding PB? Why did DoD delay research on the adverse effects of PB? In conclusion, VVA strongly urges Congress to demand that DoD put a final and complete halt to their dilatory tactics regarding all research and progress on Gulf War undiagnosed illnesses. Congress must also ensure that the VA abides by the intent and spirit of PL 105-277 and establishes immediate regulations for direct service connection for all PB-related conditions. Again, VVA thanks the House Veterans’ Affairs Committee for holding this important hearing. VIETNAM VETERANS OF AMERICA Funding Statement November 16, 1999 The national organization Vietnam Veterans of America (VVA) is a non-profit veterans membership organization registered as a 501(c)(19) with the Internal Revenue Service. VVA is also appropriately registered with the Secretary of the Senate and the Clerk of the House of Representatives in compliance with the Lobbying Disclosure Act of 1995. VVA is not currently in receipt of any federal grant or contract, other than the routine allocation of office space and associated resources in VA Regional Offices for outreach and direct services through its Veterans Benefits Program (Service Representatives). This is also true of the previous two fiscal years. For Further Information, Contact: Director of Government Relations Vietnam Veterans of America.
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