- The Washington Times - Monday, December 22, 2003

A federal court judge ruled yesterday that the Pentagon cannot compel troops to “serve as guinea pigs” in taking the experimental anthrax vaccination against their will, unless President Bush authorizes the shots in a special order.

“The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy,” U.S. District Court Judge Emmet G. Sullivan said in a 34-page order.

“Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs,” Judge Sullivan wrote.

Several million doses of vaccines have been administered to U.S. troops since 1998, with more than 900,000 troops getting vaccinated against anthrax and more than 500,000 against smallpox. Hundreds have been subjected to disciplinary reviews for refusing to take the mandatory shots.

In his ruling, Judge Sullivan said the vaccinations fall under a 1998 law passed by Congress prohibiting the use of certain experimental drugs unless those being given the drug consent or the president waives the consent requirement.

That law was passed amid concerns that use of such drugs could have led to illnesses among veterans of the 1991 Persian Gulf war, which have come to be known as Gulf War Syndrome. The law prohibits the use of new drugs, or drugs unapproved for their intended use, to service members without their informed consent.

Judge Sullivan noted in his ruling that the consent requirement can be waived only by the president, and he rejected government concerns that military discipline would be harmed if courts intervene between soldiers and their military superiors.

“The court is persuaded that the right to bodily integrity and the importance of complying with legal requirements, even in the face of requirements that may potentially be inconvenient or burdensome, are among the highest public policy concerns one could articulate,” the judge wrote.

“Moreover, the court is not convinced that requiring the [Defense Department] to obtain informed consent will interfere with the smooth functioning of the military,” he wrote.

The Pentagon has denied that the vaccine is experimental, saying it has been licensed for protection against anthrax. The vaccine has been approved by the Food and Drug Administration since the 1970s.

Clinton-era Defense Secretary William S. Cohen had ordered that the vaccinations be given, believing that Iraq and other countries had produced anthrax weapons.

In a lawsuit known as John Doe vs. Donald H. Rumsfeld, the vaccinations were challenged by unnamed members of active duty and selected National Guardsmen components of the military, as well as civilian contract employees of the Defense Department, who have submitted or have been instructed to submit to the anthrax shots without their consent.

The vaccinations, administered through what is known as the Anthrax Vaccine Immunization Program, were called experimental by the plaintiffs, who also described the government’s mandatory immunization programs as a violation of federal law.

They also noted that possible side effects from the shots included Guillain-Barre Syndrome, multiple sclerosis, angiodema, aseptic meningitis, severe injection-site inflammation, diabetes, and systemic lupus erythmatosis.

Judge Sullivan wrote that he was convinced that the anthrax vaccination was an investigational drug and that it was being used for an unapproved purpose.

He also approved the issuance of a preliminary injunction to stop the vaccinations, saying that “in the absence of a presidential waiver, defendants are enjoined from inoculating service members without their consent.”

The government was given until Jan. 30 to respond to the order.

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