A federal judge said yesterday he had significant doubts about whether the federal government has enough scientific evidence to show that the anthrax vaccine required for military personnel is either safe or effective.
U.S. District Judge Emmet G. Sullivan, who will decide in coming weeks whether to halt the Defense Department's mandatory anthrax inoculations, also criticized the government's review of the vaccine as "one of the most jumbled, confusing" processes he had ever seen.
Sullivan made his remarks in a hearing on a lawsuit filed in March 2003 by six anonymous members of the U.S. military who said the vaccine posed health risks that had not been sufficiently studied.
More than 1 million U.S. troops have been given the anthrax vaccine since the program became mandatory in 1998, many of them in preparation for duty in Iraq. Hundreds have refused the vaccine out of concern for their safety amid complaints of harmful side effects and medical reports linking the vaccine to a few deaths.
At yesterday's hearing, Sullivan questioned why the Food and Drug Administration did not formally issue a ruling that the vaccine was safe and effective against inhalation anthrax until late December 2003. That move came 18 years after the vaccine was first proposed to the FDA for use against inhalation anthrax, but just a week after Sullivan had temporarily halted the military inoculation program.
On Dec. 22, Sullivan agreed with the military personnel who filed suit, determining that the FDA had never formally approved the drug for use against inhalation anthrax, but had approved it for anthrax contracted through the skin. He temporarily halted the program, ruling that defense officials could not require troops to "serve as guinea pigs for experimental drugs" pending a final decision in the case.
Yesterday, John J. Michels, a lawyer for the six, charged that the FDA issued the ruling to protect the Defense Department's vaccination program, and said he wished he could read the e-mail messages between the two agencies during that time.
Brian D. Boyle, principal deputy associate attorney general, told Sullivan that the FDA decision was based on science. He said human studies that looked at a mix of anthrax cases -- most of them contracted through the skin, along with a few inhalation cases -- showed the vaccine was effective more than 90 percent of the time. Boyle said animal studies showed the vaccine worked on animals, though they did not prove the human immune system would react the same way.
Sullivan, however, said results of the human study might be skewed because it considered all the cases together. He suggested it would have been logical to examine separately the vaccine's effectiveness in the limited number of inhalation cases.
"Wouldn't it be more safe?" Sullivan asked. "The stakes couldn't be higher here." Sullivan said it appeared that neither the animal studies nor the human study were conclusive for humans.
Mark Zaid, an attorney who filed the suit on behalf of the military personnel, said yesterday that members of the U.S. military should have a choice about taking the vaccine until the FDA has performed conclusive studies. A more extensive human study will not be completed until 2007.