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Archives | (June 2001)
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The Anthrax Vaccine: Making Our Soldiers Guinea Pigs Part Two (cont.)
------------------------------------------------------------------ Page 2 of 6 The concerns about the lack of data voiced by the IOM echoed those expressed six months earlier at an October 1999 congressional hearing. One important witness was Dr. Kwai Chan, Director of the Government Accounting Office Special Studies and Evaluation Group. At that October 1999 hearing – over three years ago mind you – he told members of the House Government Reform Committee that: “The long-term safety of the vaccine has not yet been studied.” In that same testimony Dr. Chan also discussed the high rate of reactions to the vaccine, noting that: “About 35 percent (of the vaccine recipients) had local reactions, a figure that varied during the inoculation series.” The group of anthrax vaccine recipients Dr. Chan studied was not the only one to suffer a high rate of reactions. As noted earlier, a 1993 study of soldiers receiving the anthrax vaccine at Ft. Bragg, N.C. reported that 44 percent had one or more systemic reactions to the inoculation. Similar results were found among male soldiers in Korea, while female soldiers suffered adverse effects at a rate of between 72 percent and 74 percent. Despite this existing evidence, however, DOD officials testifying at the hearing insisted that there was no problem. At the same hearing that Dr. Chan addressed, Dr. Sue Bailey, then DOD’s top medical official strongly disagreed stating: “The Department is confident as is the Food and Drug Administration that the FDA-licensed anthrax vaccine is safe and efficacious for its intended use.” This benign assertion, though, grossly overstates the FDA’s actual position. After performing a risk/benefit analysis of the anthrax vaccine, what the FDA actually said was: “This vaccine is recommended for a limited, high-risk of exposure population.” More important, it’s only approved use was for cutaneous (skin contact) anthrax, not the more deadly inhalation anthrax. EVER-BROADER WAIVERSThe fact is that even the manufacturer of the vaccine has had continuing doubts about its safety. Why else would MBPI and its successor, the BioPort Corporation of Lansing, Michigan, have insisted on being granted three increasingly broad special waivers of liability before agreeing to produce the product? |
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