http://www.washingtonpost.com/wp-dyn/articles/A22760-2003Dec22.html
Anthrax Shots Require Consent, Military Told
By Vernon Loeb
Washington Post Staff Writer
Tuesday, December 23, 2003; Page A03
A federal judge in Washington yesterday ordered the Pentagon to stop administering an anthrax vaccine to U.S. service members without their consent, ruling that defense officials cannot require troops to "serve as guinea pigs for experimental drugs."
In blocking mandatory anthrax inoculations until a full trial can be held on the matter, U.S. District Judge Emmet G. Sullivan agreed with the contention by six unnamed Defense Department plaintiffs that the anthrax vaccine is an experimental drug "being used for an unapproved purpose" -- namely, for exposure to airborne anthrax as well as exposure through the skin. As such, he ruled, it cannot under federal law be administered to service members on a mandatory basis.
Sullivan said he was not persuaded by arguments from Pentagon lawyers that administering the vaccine on a voluntary basis would interfere with military operations in Iraq and elsewhere. But if they believe that is the case, the judge said, federal law gives them the option of obtaining a presidential waiver of service members' right to informed consent. Such a waiver, Sullivan wrote, "would be an expeditious end to this controversy."
Sullivan's ruling comes with more than 800,000 U.S. troops having received the vaccine since 1998. Many of them received the vaccine -- a series of six injections -- last year, before deploying to fight the war in Iraq.
Hundreds of other service members have refused to take the vaccine out of concerns about its safety. Many of them have been court-martialed and forced out of the military. As recently as this month, an Ohio National Guard soldier was court-martialed for twice refusing the take the vaccine and sentenced to 40 days in jail.
A Pentagon spokesman had no immediate comment on Sullivan's ruling and would not say whether those who had been disciplined could now seek to have their cases reconsidered. Charles Miller, a spokesman for the Justice Department, which represents the Pentagon in the case, said: "No determination has been made as to what our next step will be. In that it is a preliminary injunction, there is no finality to this ruling at this stage."
Mark S. Zaid, a Washington lawyer representing the Defense Department plaintiffs, said there is "no significant evidence that this vaccine is safe or effective against weaponized anthrax. It is simply an experimental vaccine."
"There have been several deaths potentially linked to the vaccine," Zaid said, "and there have been thousands of people who have become ill in cases allegedly linked to the vaccine."
Rep. Christopher Shays (R-Conn.), a leading congressional opponent of mandatory anthrax vaccines, said the ruling was "an affirmation of what we have been saying for years and years."
"The military needs to back off, make amends and restore in good standing those that have been punished," he said.
Sen. Jeff Bingaman (D-N.M.), who introduced a resolution in November asking the Pentagon to reconsider its program of mandatory anthrax vaccinations, said Sullivan's ruling gives the Pentagon an opportunity to rethink its anthrax vaccine policy, particularly now that no weapons of mass destruction have been discovered in Iraq.
The Clinton administration launched the anthrax immunization program in 1998 with the intention of requiring all 2.4 million military personnel to receive the vaccine. But the program faltered almost immediately when the vaccine's only manufacturer, BioPort Corp. of Lansing, Mich., was unable to obtain a license from the Food and Drug Administration because of faulty manufacturing processes.
As it worked on plans for invading Iraq, the Bush administration announced in June 2002 that it was resuming mandatory anthrax vaccinations for service members being sent to "high-threat" areas such as Iraq and Afghanistan for more than 15 days.
Eugene R. Fidell, a Washington lawyer who is an expert on military law, lauded Sullivan for his ruling. "It is quite remarkable that at a time of active military operations, the federal courts remain open and ready, when the record supports it, to order the government around," Fidell said. "It's really quite remarkable."
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