Judge Sees Little Evidence to Support Anthrax Vaccine
www.washingtonpost.com/wp-dyn/articles/A55581-2004May25.html
The Washington Post
Judge Sees Little Evidence to Support Anthrax Vaccine
By Carol D. Leonnig
Washington Post Staff Writer
Wednesday, May 26, 2004; Page A25
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.
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