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cuy s « THE PENTAGON'S TOXIC oe Fair Article ; Page 8 of 10 Of more than 160 companies that were asked to make anthrax vaccine, all but one said no. Only Lederle-Praxis Biologicals of Pearl River. New York, signed on. Under the suspension of General Ronald R. Blanck and Colonel Harry Dangerfield, Project Badger organized the production of additional anthrax vaccine at the National Cancer Institute's Frederick Cancer Research and Development Center, located at Fort Detrick. Both Lederle and N.C.I. were unlicensed and unregulated by the EDA The plan called for subcontractors to ship vaccine to the only FDA-licensed manufacturer of anthrax vaccine, Michigan Biologic Products Institute (now BioPort), in Lansing, Michigan, for bottling, labeling, potency testing, and storage. This would have been another breach of federal safety regulations. As an earlier task force memo from October 10 stated "It must be noted that any firm other than Michigan will produce a vaccine under an I-N.D. and not a licensed product." ILN.D. stands for “investigational new drug," which requires special approval from the ED.A. for use. The army—as the executive agent for the Defense Department's biological warfare vaccine program — should have sought that approval. It did not, and N.C.L. confirms that it never applied for an I.N.D. to produce anthrax vaccine. (Weth-Ayerst International, which now owns Lederle-Praxis, could not be reached for comment.) The FDA must approve all vaccines used in the United States and also license the production sites, military vaccines not excepted. a General Blanck disputes this scenario unequivocally. "I have no knowledge of anybody producing any anthrax vaccine other than Michigan," he says. "Nobody provided us or produced any vaccine, because the war ended, basically, is what happened.” By the first week of December 1990, Project Badger had begun plans to test other experimental vaccines on US. troops in the Gulf. Project scientists referred to this endeavor, rather portentously, as a “Manhattan-like project," or simply a “Manhattan Project." They organized a crash program to manufacture, or purchase, at least four experimental vaccines: Enterotoxigenic E. Coli, Hepatitis A, Centoxin, and Shigella. At least two other experimental products were ultimately used: PB. pills and botulinum toroid vaccine, for both of which the army received from the FDA a waiver of informed consent. As for the mysterious "Vaccine A," variously cited as Vac A, Vac A-i, or Vac A-2 in the shot records of sick veterans such as Colonel Smith, declassified Defense Department documents identify it as anthrax vaccine. Dr. Gregory Dubay, who commanded the 129th Medical Company, a former Alabama National Guard unit out of Mobile, gave thousands of anthrax vaccinations to troops. He says, "Each soldier had to read a classified sheet of instructions, stating that he, or she, was receiving a secret shot, and that this was so for reasons of operational security. You don't want to tell the enemy that you're getting protection against one of his “weapons.” Dubay-who both administered and took the vaccinations—says that he was under orders not to record the inoculations in the soldiers’ medical records, and that the troops were not given a chance to decline the shots. "You were just marched through, and that was it.... Then our commander told us to destroy everything connected with it—the empty vials, the boxes, and the package inserts. We burned them all in 55-gallon steel drums back behind the tents." The Pentagon says that 150,000 Gulf War troops received anthrax inoculations. There are no documents available proving that the army used a squalene adjuvant in the unapproved vaccines, and the army has specifically denied it. But that still leaves Asa and Garry with more than 100 sick veterans who had their shots and now test positive for antibodies to squalene. Why might the army have used squalene instead of alum, the only adjuvant approved for human use? Probably because squalene was stronger. The licensed anthrax vaccine was relatively weak. Immunity wasn't achieved with one shot. It took six shots, administered over a period of 18 months, then an annual booster. In 1991, tens of thousands of U.S. troops arrived in Saudi Arabia only a month before the coalition forces began the ground war. Most could get only two shots out of the six-shot regime; some just got one. And there was, perhaps, an even more compelling reason to enhance the vaccine. Two former members of Project Badger say the coalition suspected that Iraq had engineered a more powerful anthrax bio-weapon. “We were concerned that Saddam may have made anthrax resistant to penicillin,” says one, who does not wish to be identified. "We knew he had the skills to do that people who had trained in the United States, who had the skills to turn the bug into a resistant bug....The Brits were the ones who gave us the information, actually. We actually knew who those people were." The anthrax vaccine licensed by the ED.A. back in 1970 was designed to protect against anthrax germs that occasionally infect wool sorters and veterinarians. It was not known to be effective against a biowarfare agent that Iraq had possibly made more lethal. It is plausible that the army thought an experimental anthrax vaccine was worth the risk, especially since squalene was considered to be a superior adjuvant. However, this was a hypothesis. Administering such a vaccine to the troops would have been tantamount to a human experiment. In order to conduct a legal trial with squalene, one would have to file an "investigational new drug” application with the FDA and have that application approved. This did not happen. In October 1997, the British revealed their attempts to boost the efficacy of their anthrax vaccine during the Gulf War by using a pertussis vaccine as an adjuvant. This controversial combination had caused serious http://www. idir.net/~krogers/vantyfair.html 11/8/2005