U.S. judge orders a halt to military anthrax shots

FDA did not follow rules for deeming drug safe and effective, decision says

October 28, 2004|By Bob Evans and Stephanie Heinatz | Bob Evans and Stephanie Heinatz,DAILY PRESS

WASHINGTON - A federal judge ordered the military yesterday to halt its contentious mandatory anthrax vaccination program, ruling that the government had failed to follow the rules for declaring an experimental drug safe for public use.

"The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all, public scrutiny," wrote U.S. District Judge Emmet G. Sullivan.

A Pentagon news release issued after the ruling said the military is reviewing the decision and will "pause giving anthrax vaccinations until the legal situation is clarified."

"This is huge," said Steve Robinson, executive director of the National Gulf War Resource Center, a veterans' rights group. Veterans have been arguing for years that the vaccines were not adequately reviewed by the government before military personnel were required to take them.

The Government Accountability Office found that 85 percent of the pilots and air crews it studied as part of a review of the vaccine complained about side effects. The agency, which is Congress' investigative arm, also said that the number of adverse reactions among military personnel was more than double what the drug's manufacturer claimed, and that the manufacturer had problems keeping the vaccines pure.

Adverse reactions to the drugs were so great, the GAO said, that many experienced troops were leaving the military because of the vaccination program.

Those who remained but refused to get the shots were punished - hundreds of them, maybe thousands, Robinson said. Exact numbers are not known because the Pentagon refuses to say how many, he said.

The military instituted the mandatory vaccination program in 1997 to protect troops that might be deployed to the Persian Gulf and other regions where biological weapons might be used. The program was eventually expanded to much of the armed services.

900,000 vaccinated

More than 900,000 troops have been vaccinated, according to the Medical Letter on the CDC & FDA, a news service that covers government health issues.

Less than a year after the program started, Congress approved a law prohibiting the Pentagon from using experimental drugs on members of the armed forces without their consent, or without a presidential order. The law was passed because of problems with the use of experimental vaccines in the 1991 Persian Gulf War.

Sullivan cited that 1998 law in December when he ruled that the Pentagon was forcing troops to get the shots illegally. He noted that no president had ordered use of the drug and that it was not approved by the Food and Drug Administration for widespread use to fight inhaled anthrax.

Temporary stop

Vaccinations stopped, but only for a few days. Eight days after the December ruling, the FDA entered the debate and ruled that the drug was "safe and effective" for preventing inhaled anthrax. Without that "safe and effective" designation, the drug is considered experimental.

Until that ruling, the drug had been listed in the category of "not generally recognized as safe and effective" for prevention of inhaled anthrax for more than 20 years.

Sullivan ruled yesterday that the change in categories was illegal because it did not allow meaningful public comment on the switch, as the law requires. He noted that although the agency had advertised that it was considering such a change in 1986, and had received four comments in response, it never bothered to issue a ruling until after the Pentagon's program was halted by the court last year.

Change in FDA status

When the FDA labeled the drug safe for use last year, most of the evidence it cited for support wasn't available during the 1986 review, Sullivan noted.

As a result, the public never got a chance to comment, rebut or challenge the data, he said.

The failure to follow the rules required him to stop the mandatory program, Sullivan wrote.

Mandatory vaccinations cannot resume until a higher court either overrules Sullivan's finding or decides to issue an order to allow the shots while it reviews the lawsuit. The lawsuit was filed by six people who were members of the military or employees of the Department of Defense forced to take the shots.

Despite the court's ruling, the Pentagon said that it "remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective."

The Daily Press of Newport News, Va., is a Tribune Publishing newspaper.

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