Washington Post: Anthrax Shots Require Consent, Military Told

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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. , 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. 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. "

Meryl Nass, MD

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