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With anthrax fears running high these days, it would seem that few people would refuse a vaccine that offers possible protection from the disease. But hundreds of members of the U.S. military have done just that and risked their careers rather than submit to treatment they say is dangerous. Now, two cases — one in military court and one in federal court — challenge the legality of the Defense Department’s mandatory anthrax vaccination program. It’s a tough case to make, say military justice experts. “The military is based on immediate obedience to all orders except those that are plainly illegal,” says Eugene Fidell, who heads the military practice group at Washington, D.C.’s Feldesman, Tucker, Leifer, Fidell & Bank. “It would be highly deleterious if people could decide on their own which orders to obey and which to disregard.” The Pentagon has consistently maintained the safety of its vaccine. Since the start of servicewide inoculation against anthrax in 1998, more than 500,000 members of the armed forces have been vaccinated, including former Secretary of Defense William Cohen. But the program also sparked criticism from former service members, Gulf War veterans who were given the shots, and members of Congress who claim that the vaccine was responsible for adverse reactions, including rashes, joint pain, blackouts, loss of vision, seizures, and death. Among the hundreds who refused to take the shots was Air Force mechanic Christopher Washington, whose case is before the nation’s highest military court, the Court of Appeals for the Armed Forces. In January 2000, while stationed in Saudi Arabia, Washington refused to receive the last injection of the six-shot vaccination, claiming he was concerned about side effects. As a result he was brought before a special court martial — the rough equivalent of misdemeanor court — and sentenced to two months’ confinement and a bad conduct discharge for willfully disobeying the order. The Air Force Criminal Court of Appeals affirmed the decision in April 2001. “The appellant’s refusal to be inoculated is a direct flouting of military authority,” the court stated. “A military accused cannot justify his disobedience of a lawful order by asserting that his health would be jeopardized. Putting one’s life on the line for the sake of the mission is the very essence of military duty.” Lawyers for the prosecution say Washington’s case is clear-cut. “From our standpoint, Washington simply does not have a strong argument that would excuse him from obeying a direct order,” says Col. Craig Smith, chief of military justice within the Office of the Air Force Judge Advocate General. “The Department of Defense concluded that the vaccine is safe and effective for use, and Washington’s commander in the field gave him a straightforward order related to his military duty.” Smith points to a recent decision by the Court of Appeals for the Armed Forces upholding the 1996 conviction of Michael New, a former Army medic who refused to wear the blue beret and insignia of the United Nations when assigned to a U.N. peacekeeping mission. New argued that the order violated Army regulations and the U.S. Constitution. The Court of Appeals for the Armed Forces rejected his claim that the members of the special court martial, not a judge, should have determined the legality of the order. Washington’s appeal rests on a similar question. His attorneys argue that the military judge was wrong to prevent Washington from putting on evidence about the safety of the anthrax vaccine. Another issue being appealed is the severity of Washington’s sentence. Of the 140 members of the Air Force who refused the vaccination, Washington was the only one to receive a bad conduct discharge. The prosecution maintains that aggravating factors contributed to the severe punishment. Before being stationed in Saudi Arabia, Washington made two requests to leave the Air Force. According to the government, those requests, combined with the fact that Washington submitted to five shots, but refused the final dose, suggest that a desire to leave the Air Force, not health concerns, prompted his disobedience. Washington’s attorneys declined to comment for this article. The five judges of the Court of Appeals for the Armed Forces should decide by early November whether to take up Washington’s case. Like the U.S. Supreme Court, the Court of Appeals for the Armed Forces has discretionary review. It typically hears fewer than 20 percent of the cases that come before it. Last year the court declined to review the case of a Marine Corps lance corporal who was similarly discharged after refusing to take the anthrax vaccine. But the timing of Washington’s case and its obvious implications for the current conflict may make it appealing. “The court is going to look for cases where the path of the law will be benefited by their decision,” Fidell says. “Given the current climate, I think it’s highly likely that the court will grant review.” Fidell notes that a Canadian military judge threw out charges last year against a member of the Canadian forces who refused to take the vaccine while stationed in Kuwait. But he doubts Washington will be successful. “I think it’s a hard case to argue that an order to receive the anthrax vaccination is unlawful and it’s getting harder every day.” TRYING A CIVILIAN COURT In an attempt to sidestep the military courts, one group of vocal vaccine opponents is turning to the federal courts. Former Air Force officer Sonnie Bates and Air Force physician John Buck sued the Department of Defense, the Department of Health and Human Services, the Food and Drug Administration, and vaccine supplier BioPort Inc. in U.S. District Court for the District of Columbia. The plaintiffs’ lawyers, John “Lou” Michels Jr., a partner in the McLean, Va., office of McGuireWoods, and Mark Zaid, a partner at D.C.’s Lobel, Novins & Lamont, have been involved in the vaccine controversy since the program’s inception. “Right now people are so panicked their sole focus is speeding up production of the vaccine. No one is looking at the problems with the vaccine,” says Michels, a lieutenant colonel in the Air Force Reserve. The suit, which was brought in May, has been assigned to Chief Judge Thomas Hogan. It seeks declaratory judgment that the anthrax vaccine is an investigational new drug being used in a fashion for which it does not have FDA approval. Such labeling would require the Pentagon to secure the consent of service members before performing the vaccination or secure a presidential waiver. “It would effectively stop the military program as it is now operated,” Michels says. According to the complaint, the Department of Defense became interested in finding a vaccine to protect troops against anthrax in 1985. The vaccine now used was already in existence, developed by the state of Michigan, but was dismissed as insufficient because it had not been developed to prevent the inhaled form of anthrax. However, instead of selecting a new manufacturer, the Department of the Army in the mid-1990s began working with Michigan Biologic Products Inc. — the state’s licensed manufacturer and predecessor to BioPort — to get the vaccine approved for use against inhaled anthrax. In 1996, the company submitted an application for the vaccine so that it might be licensed for that purpose. Under FDA regulations, that application means the anthrax vaccine, as used by the military, ought to be considered an investigational new drug, Michels argues. According to an executive order signed last year, the Department of Defense must obtain informed consent from each individual before administering an investigational drug to members of the military. The government filed final briefs in a motion to dismiss on Oct. 5, arguing that neither Bates nor Buck have suffered an injury that the court can remedy: Bates, because he resigned rather than take the vaccine and is no longer a member of the military; Buck, because he was not dismissed as a result of his refusal to take the vaccine. Michels says he finds it troublesome that representation of the government has been consolidated in the Justice Department’s Office of Consumer Litigation. After purchasing Michigan Biologic Products Inc. in 1998, BioPort halted production of the anthrax vaccine and launched a $16 million plant renovation. The new facility failed FDA investigations in 1999 and 2000. BioPort cannot ship new supplies until the plant receives FDA approval. “They seem to be merging DOD’s interest with the FDA’s interest. I don’t think that’s quite kosher,” Michels says. “The Defense Department has literally been bulldozing this through FDA.” Rep. Christopher Shays, R-Conn., who chairs the House Committee on Government Reform Subcommittee on National Security, has also complained that the Defense Department has put improper pressure on the FDA. “It’s a very misguided program,” Shays says. “It may be that the military is going to use this even though it’s not FDA-approved, and that’s very unsettling.” For a brief time, it had seemed that the legal disputes over mandatory anthrax vaccine might be moot. Since June 2001 only members of high-risk special forces have been vaccinated because of a dwindling supply of the vaccine. But now inoculating U.S. troops against anthrax is once again a top priority at the Pentagon. On Oct. 12, BioPort again filed for FDA approval and Secretary of Defense Donald Rumsfeld says the Pentagon continues to support the vaccination program. “We’re going to try and save it,” Rumsfeld said last week at a press briefing. “We are going to give one more crack at getting the job done.”

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