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"dictate the use of unapproved FDA-regulated products" in the Persian Gulf, but they would prefer to obtain a waiver from FDA. "The issue was debated by the two agencies for several months. Finally, at a meeting on December 31, 1990, it appeared that an agreement was reached. DoD officials agreed that the vaccine would be administered by trained individuals with a health care background, and that information would be provided orally "at minimum, and in written form if feasible, to all personnel receiv- ing the vaccine”. DoD officials said the feasibility of distributing an information sheet would depend on many factors, and would vary from location to location within the military theatre of opera- tion. DoD officials "reiterated that at least verbal information would be provided to each person receiving the vaccine”. The FDA Informed Consent Waiver Review Group recommended that pregnant women be excluded from receiving the vaccine and that information about the vaccine be “posted at places where vaccine is administered". However, DoD argued that pregnant women would be at greater risk from exposure to botulism toxins than to the vaccine, and FDA agreed that instead of excluding pregnant women, a statement would be added to the recipient information stating that, "If you are pregnant, it is not known if this vaccine will hurt the unborn baby; however, most vaccines do not." "Despite these agreements between FDA and DoD, and DoD's official subsequent decision to administer the vaccine voluntarily, many PGW veterans claim that they were not told what vaccine they were being given, or what the risks were, either orally or in writing [See Figures | and 2]. Many report that they were told not to tell medical personnel that they had received a vaccination, even if the vaccination caused pain or swelling. No record of the vaccine was available in medical records; as a result, physicians who were concerned about any local or systemic reactions were uninformed about the possible causes. Veterans who claim they were harmed by the vaccine or pyridostigmine frequently have no proof that they were vaccinated or took the pills, or that they had an adverse reaction. Moreover, virtually none of the soldiers received more than two of the botulism vaccinations, even though DoD informed DA they would administer the three shots neces- sary for protection... "On January 8, 1991, Dr David Kessler, FDA Commissioner, wrote to the Assistant Secretary of Health of DoD regarding the waiver for informed consent... In his letter, Dr Kessler agreed that since there was "no available satisfactory alternative therapy" for protection...he would “concur with your assessment that informed consent is not feasible”. "Since the end of the Persian Gulf War, DoD has repeatedly requested that the waiver of informed consent be made permanent, arguing that "to not finalise it provides an. arguable defect under the Administrative Procedures Act and leaves both Dod and FDA open to greater liability". To finalise the interim rule would grant unrestricted use of investigational drugs by military personnel, even when efficacy and safety have not been established.""" "In the early months of 1994, staff of the Senate Committee on Veterans’ Affairs interviewed 146 Persian Gulf War veterans... The respondents complained about numerous negative side-effects of the vaccines and pills... One claimed that two people in his unit had heart attacks after taking [the experimental drugs] and-thal one died. There were numerous complaints about the quality of care and the lack of compassion of VA physicians and nurses. This included a doctor's comment claiming that the Persian Gulf War “wasn't a real war”, and a patient's complaint that a doctor told her that she was fine, after using a stethoscope that he had forgotten to put in his ears.'? "Here are a few selected comments from the survey: On Medical Records: * Seven months of medical records are missing. * Asked for my medical record and was told all had been disposed of. * Medical record is lost forever. * Twenty years of medical records are now mysteriously gone. * All our medical records were destroyed. + Doctors refused to put vaccinations in my medical record. * Was told my leave would be held up if I wanted copies of my medical record. * My medical record says my illness is not related to Agent Orange. * This VA doctor has the wrong war! received more than ‘two of the botulism vaccinations, e' even though On Vaccinations: DoD informed DA they would administer the three shots neces- * Passed out after anthrax shot. * We were told not to tell we got sary for protection... anthrax shots because there wasn't enough for British and French "On January 8, 1991, Dr David Kessler, FDA Commissioner, troops. * Several reported flu symptoms at time of vaccinations. * I wrote to the Assistant Secretary of Health of DoD regarding the argued that I was pregnant, so finally they let me not take the shot. waiver for informed consent... In his letter, Dr Kessler agreed that —* It was a big argument. * They made me sign something, but the since there was "no available satisfactory alternative therapy" for form was folded so I couldn't read what I signed. * We were 2 ordered to sign the consent form. * I could : refuse the shot if I wanted court martial. * I tried to refuse anthrax and was threatened with Leavenworth. On the VA Hospital System and Doctors: * Military doctors are harassing me because I'm sick. * VA doctors don't want to know what is making you sick. « VA is min- imising our illnesses. * Navy doctors told \ \ my wife to terminate her pregnancy. Pp me) = 7 On Illnesses: ee So SSS + Lots of men in the unit have swollen tes- ney % AE Caan So: ticles. * Sometimes I forget to feed my son. ¢ 75 I got lost while going to get my children 9 SP. 4 2 B- from school. * I don't have a spleen and oa -_ wonder if I should have taken those drugs ? a aad F?- and vaccines."' Continued on page 78 ali es ns AB Ea D+ - o- 2 Pf 3Bo- ir wr) De a ree ee eo 22 © NEXUS APRIL - MAY 1995 SURVEY OF 146 PERSIAN GULF WAR VETERANS