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DOD: Anthrax Not Experimental Vaccine
United Press International
December 25, 2003

WASHINGTON - Senior Pentagon officials rejected a federal court's assertion that the controversial anthrax vaccination program uses military personnel "like Guinea pigs" and said it is reviewing whether it must comply with the court order to halt the program.

"We don't perform experiments on the U.S. military. We don't use the armed forces as Guinea pigs," said William Winkenwerder, the assistant secretary of defense for health affairs at a Tuesday Pentagon briefing.

The Justice Department is applying for a stay on the judge's Monday order, which required a suspension of the five-year old vaccination program on the grounds that the inoculation is not approved for use against inhalation anthrax.

The military currently requires personnel deploying to high-risk regions like Korea and Iraq to receive the controversial six-shot treatment. It has been in use since the 1970s for treating veterinarians against the naturally occurring disease.

"The vaccine has been around for 40 years. It is not experimental. It's approved by the FDA. And from a military standpoint, I think it's extremely important," Chairman of the Joint Chiefs of Staff Gen. Richard Myers said Tuesday at the Pentagon. "As you know, when we went into Iraq, we had all the troops in their chemical protective gear, because we thought there was a very real threat of either chemical or biological weapons, and in particular, anthrax was a big worry."

However, the military uses it not just to prevent anthrax infections of the skin but pulmonary or inhalation anthrax -- a use for which the vaccine has never been proven effective. Studies have only measured its effect against subcutaneous anthrax.

Hundreds of military personnel rejected the shot between 1998 and 2001, according to Winkenwerder. Only 10 have rejected the shot since Sept. 11, 2001, he said. Winkenwerder and other senior officials could not say how many service members have been court-martialed for refusing the vaccine.

Winkenwerder also would not say whether service members who refuse the shot in the wake of the judge's order would be court-martialed.

According to the Pentagon, taking the shot is like wearing a helmet or bullet-proof vest -- a necessary force-protection measure.

But Judge Emmet Sullivan, a U.S. District Court judge for the District of Columbia, disagreed in a decision handed down Monday.

"The men and women of our armed forces put their lives on the line everyday to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs," Sullivan wrote.

The case was filed in March by six anonymous "John Does," reportedly three military personnel and three government contractors who objected to the vaccine.

Sullivan's decision hinged on the fact that Congress, after the 1991 Persian Gulf War, passed a law banning the use of experimental drugs on military personnel without their informed consent. Federal law also allows the president to waive that law.

Because the FDA has not licensed the vaccine specifically for inhalation anthrax, Sullivan said it must be classified as an investigational drug when used for that purpose and given only voluntarily, with informed consent, unless there is a presidential waiver allowing otherwise.

Winkenwerder disagrees, asserting the FDA has issued "guidance to us directly on that question that easily allows for the conclusion it is effective against inhalation anthrax."

However, there is enough ambiguity that the Pentagon is seeking "clarification" on that guidance, he admitted.

Sullivan's decision also notes that the danger of side effects from anthrax are far more frequent than originally reported by the company that produces it. The original information insert provided with the vaccine reported a 0.2 percent side-effect rate.

It was "recently revised to reflect and adverse reaction rate between 5.0 percent and 35.0 percent," Sullivan wrote.

Pentagon officials argue that is a normal rate for any vaccine and refers to non-serious local reactions like bumps and swelling.

At least six deaths have been linked to the vaccine, according to the court. Winkenwerder said none of the deaths were conclusively linked to the vaccine but were included in company literature for legal reasons.

According to Winkenwerder, there were 1,700 adverse reaction reported to a review panel. Of those 69 were hospitalized. According to the review, only 11 of those were due to the anthrax vaccine.

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Copyright 2003 United Press International. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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Copyright 2012 . All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


 


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