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Pentagon Resumes Anthrax
Shots After Judge's Ruling

By Will Dunham
1-8-4


WASHINGTON (Reuters) - The Pentagon said on Wednesday it will immediately resume compulsory anthrax vaccinations for U.S. troops after a judge lifted an order barring them without individual service members' consent.
 
U.S. District Judge Emmet Sullivan, granting a request by the Bush administration, issued a stay of his Dec. 22 order until a trial could be held on a suit filed by six unidentified troops and civilian workers for the Department of Defense who challenged the policy.
 
Sullivan's ruling came eight days after the Food and Drug Administration declared the vaccine safe and effective against the form of anthrax in which airborne bacterial spores are inhaled into the lungs -- the most likely way U.S. troops would face the disease on a battlefield.
 
In a two-page order, the judge called the timing of the FDA's action so soon after his earlier ruling "arguably highly suspicious." Plaintiffs' lawyers accused the FDA of acting hastily due to political pressure from the Pentagon.
 
Sullivan said that, regardless of the timing, the FDA's action addressed his earlier concern that the agency had never categorized the vaccine as safe and effective against inhalation anthrax.
 
The federal judge left in place a prohibition on the Pentagon requiring the six plaintiffs to get the shots.
 
In a memo to department leaders, Pentagon official David Chu said that the vaccination program "complies with all legal requirements, and there is now no judicial restraint" on giving the shots.
 
"Therefore, you should immediately resume the anthrax vaccination program," Chu said.
 
PUNISHED FOR REFUSAL
 
Worried about possible dangerous side effects, hundreds of U.S. service members have refused the vaccinations since the program began in 1998. Many have faced punishment, including being thrown out of the military.
 
Sullivan, in his Dec. 22 ruling, accepted the plaintiffs' contention that the vaccine was experimental and employed by the Pentagon for an unapproved use: protecting against inhalation anthrax as well as less-hazardous exposure through the skin.
 
The judge wrote at the time that without informed consent or a presidential order, the Pentagon could not require that troops "serve as guinea pigs for experimental drugs."
 
But the FDA on Dec. 30 endorsed the vaccine as protection against inhaled anthrax, after 18 years of inaction on the matter. That action prompted the Justice Department to file a motion asking the court to lift the ban on the mandatory vaccines. They had been halted following the Dec. 22 order.
 
Mark Zaid, a lawyer for the plaintiffs, expressed disappointment in the judge's decision but said he did not plan to appeal.
 
"We will be exploring the extent to which the Defense Department put undue pressure on the FDA," Zaid said.
 
The plaintiffs filed an amended lawsuit shortly before midnight on Tuesday, calling the FDA's action "so arbitrary and capricious as to amount to bad faith."
 
Zaid said the FDA ruling only served to confirm the vaccine had previously been used illegally by the Pentagon and that any troops or civilian contractors disciplined for refusing the shots had been unjustly punished.
 
 
The plaintiffs also notified the judge they may seek class-action status, which could allow more than 2.5 million active-duty, National Guard and Reserve troops and contractors to join the case.
 
Defense officials have said about 1 million troops have been given the shots since the vaccination program began.
 
 
Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

 

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