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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