FDA Fails to Halt Anthrax Anxiety; On the heels of a federal judge's decision that stopped the U.S. military's controversial anthrax vaccinations, the FDA suddenly declares the shot safe and effective

0 Comments | Insight on the News, Feb 2, 2004

Byline: Timothy W. Maier, INSIGHT

For thousands of Gulf War veterans the holiday season was a roller-coaster ride. Many celebrated when a federal judge ruled in late December that the anthrax vaccine was experimental if used to protect against inhaled anthrax instead of anthrax poisoning by skin contact. The ruling immediately put a halt to the military's anthrax-vaccination program in which more than 1 million troops already have been inoculated since 1998. But eight days later, on Dec. 30, the U.S. Food and Drug Administration (FDA) dropped a bombshell that in effect reversed the court ruling by declaring the anthrax shot was safe and effective against anthrax delivered by aerosol spray.

In 1972 the FDA gained jurisdiction over vaccines and related products from the National Institutes of Health. In 1985 the FDA proposed the anthrax vaccine and some others as safe and effective against bacterial infections but never completely certified those conclusions. The recent finding, eight days after the court ruling on anthrax vaccination of U.S. troops, was said to be part of a process to certify proposals and findings since the FDA took jurisdiction more than 30 years ago. The official explanation for the timing is that the anthrax attacks of 2001 pushed the FDA to finish the job and issue a final rule based on a review by an expert panel.

In any case, the FDA released its final ruling with a prepared statement that clearly indicated a bureaucratic reaction to the decision of the federal court. "A recent ruling by a United States District Court for the District of Columbia gave the opinion that the anthrax vaccine should be classified as 'investigational' with regard to protecting against inhalation anthrax," the FDA stated. "Today's final rule and order make it clear that FDA does not regard the approved anthrax vaccine as 'investigational' for protection against inhalation anthrax." So that no one missed the point the FDA also declared that this ruling should be noted in any further litigation.

"This will end all lawsuits," claims D. Jacques Smith, an attorney for Michigan-based BioPort Corp., the sole supplier of the anthrax vaccine. "We always believed that the vaccine had a very low risk. The risks are equal to the flu vaccine that I received last month" [see "Flu Secrets You Should Know," p. 18]. Except for one slight detail: Coroners do not cite the flu vaccine itself as the cause of death, while the anthrax and smallpox vaccines given to U.S. military troops have been listed as the cause of death for at least a half-dozen veterans, according to civilian medical examiners. Pentagon doctors in turn dispute those conclusions.

The immediate approval of the anthrax vaccine set off a firestorm of criticism among veterans who believe they are being subjected to unnecessary risk. One veteran put it this way: "The ruling is decades overdue and rife with problems, including relying on animal data to fill the legal void created due to the lack of valid human data. A full vetting of the facts is required in order to hold Department of Defense [DoD] and FDA officials accountable for their abuses of power and discretion." That full vetting is not likely to happen.

Congress disappeared from the debate shortly after Capitol Hill offices were struck by the anthrax mailings in 2001, and it now appears unlikely that there will be hearings about these problems, especially in light of the recent FDA final ruling.

Immediately seizing on the FDA's decision, the Justice Department requested that U.S. District Judge Emmet G. Sullivan set aside his preliminary ban and proceed with the class-action lawsuit against the Pentagon by six "John Doe" plaintiffs seeking to stop the vaccination program. Sullivan, who had ruled that U.S. soldiers should not be used as "guinea pigs" for experimental drugs, since has backpedaled in light of the FDA's finding. While his ban was in line with findings of experimentation by congressional reports from both the House and Senate, the FDA's ruling left him no choice. He lifted the ban on Jan. 7, but not before he called the FDA ruling "highly suspicious," following as it did so closely upon the heels of his injunction.

"Only after the issuance of an injunction, up pops a federal rule," Sullivan declared with acid sarcasm to Justice Department attorney Shannen Coffin, who is representing the Pentagon in the lawsuit filed by the six John Does. "And you're telling me it's coincidental?"

"I'd stand on a stack of Bibles and tell you it's coincidental," Coffin replied to Sullivan.

"That's an amazing coincidence," Sullivan shot back.

The FDA claims its final ruling was made prior to Sullivan's holding even though it was not made public until after the ban was implemented. Nonetheless, Sullivan's ban prevented several thousand troops from receiving the inoculation before being sent out to high-risk areas to fight the war on terrorism. Coffin argued that every day the injunction was in place meant that 1,000 additional troops could face harm for being unprotected from anthrax.