Wednesday, February 09, 2005

DoD seeks to resume anthrax shots on voluntary basis

Government attorneys are asking a federal judge to modify his 3½-month-old order that halted the Pentagon’s mandatory Anthrax Vaccine Immunization Program so shots can resume on a voluntary basis.
Judge Emmet Sullivan of the U.S. District Court for the District of Columbia said in an Oct. 27 ruling that the Food and Drug Administration failed to follow its own procedures when it determined a year ago that the anthrax vaccine is safe and effective for all forms of the disease, including the inhalation form, which the Pentagon says is a germ warfare threat.

Sullivan’s order said the vaccine could be used to protect against inhalation anthrax only if a service member gives informed consent — which involves specific procedures outlined in federal law — or if the president waived the right to informed consent, also allowed under federal law.

But Sullivan’s order did not address another federal law known as Project BioShield, under which the Pentagon recently received “emergency-use authority” from the FDA to resume anthrax shots for troops as long as they have the option to refuse. It was the first time any federal agency requested such authority under that law.

Because this had not previously been an issue in the ongoing court case, government lawyers want Sullivan to give his assent before the Defense Department moves forward.

“Out of an abundance of caution, defendants respectfully request that the court modify its injunction to expressly acknowledge the legality of DoD’s use of [anthrax vaccine] pursuant to the emergency-use authority,” states the 12-page motion filed by the Justice Department on behalf of the Pentagon.

“The resumption of AVIP as a voluntary program is consistent with the spirit of the court’s prohibition of [anthrax vaccine] inoculations in the absence of informed consent or a presidential waiver of the informed consent requirement.”

John J. “Lou” Michels, an attorney for six service members and civilian defense employees who sued to stop the mandatory program on the basis that the vaccine wasn’t licensed to protect against inhalation anthrax, said he expected the government to ask Sullivan’s permission to resume the program.

But he was surprised the government’s motion did not include a brochure explaining to service members that they don’t have to take the shots, which, essentially, is the consent document.

Michels said there is no indication of how government officials plan to monitor the consent issue.

“Apparently, consent is going to be manifested by taking the shot,” he said.

A hearing is scheduled for Feb. 14 in Sullivan’s court to discuss the government’s motion to resume the vaccine program on a voluntary basis.

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