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"Protecting the health and informed consent rights of children since 1982."

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By Neely Tucker

Washington Post Staff Writer

Wednesday, May 15, 2002; Page A10

An attorney for two Air Force officers told a federal judge in Washington yesterday that the Department of Defense does not have the right to inoculate troops with an anthrax vaccine that has not received final approval by the Food and Drug Administration.

In a case that has implications for the military's plan to immunize most of its 2.4 million employees against the disease, lawyer John J. Michels Jr. said the military should call the medication an experimental drug. That would allow troops to refuse it if they wished.

"The current program is a conscious, knowing violation of the law," said Michels. He is representing an Air Force major who has since left the service and an Air Force physician, both of whom refused to take the vaccine in 2000.

But U.S. District Judge Reggie B. Walton also listened to oral arguments from a Justice Department attorney who said the FDA did not object to the four-year-old vaccination program. After a two-hour hearing, Walton said he was doubtful that one of the plaintiffs, no longer in the service, had legal standing to press the case. He also said he was reluctant for the court to issue an order about a medical issue, as opposed to health care experts.

The military began immunizing service members against anthrax exposure in 1998. More than 500,000 active and reserve troops took the six-shot vaccination before it was halted early last year when supplies were depleted. The vaccinations are to resume, Justice Department lawyer Andrew E. Clark said yesterday, but there was no date mentioned.

So far, about 500 service members have refused to take the vaccine. They have cited health and safety concerns, because it was unclear if the FDA intended the drug to be used to fight inhalational anthrax, the deadliest form of the disease.

Yesterday, Clark told the judge that the labeling on the drug did not specify what forms of the disease it was most effective against. When the Defense Department asked the FDA if it was safe to use the vaccine against potential exposure to inhalational anthrax, the acting director of the agency answered that the military's program "was not inconsistent" with its labeled use.

"The FDA has spoken on this issue," Clark said.

Michels countered that the letter did not meet the FDA's rigorous method of agency approval.

While some service members have filed suit contending the vaccine program violates their constitutional rights, former Air Force major Sonnie Bates and Air Force Capt. John Buck, a physician, filed suit last year, objecting to the lack of FDA approval.

Bates left the service last year with a general discharge after refusing to take the vaccine; he now is a commercial pilot. Buck is facing court-martial proceedings at Keesler Air Force Base in Biloxi, Miss.

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