Judge Sees Little Evidence To Support Anthrax Vaccine

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Wed, 26 May 2004 06:23:48 EDT

Judge Sees Little Evidence To Support Anthrax Vaccine

 

http://www.washingtonpost.com/wp-dyn/articles/A55581-2004May25.html

 

 

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.

 

© 2004 The Washington Post Company

 

 

 

 

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