Stars and Stripes: Air Force Doctor, Former Pilot Sue to Have Anthrax Vaccine Declared Experimental
Dr. John Buck
Air Force Doctor, Former Pilot Sue to Have Anthrax Vaccine Declared
Experimental
May 4, 2001
Dave Eberhart
Stars and Stripes News Editor
Capt. John Buck, a U.S. Air Force physician facing court-martial for refusing the military’s anthrax vaccinations, and former Air Force Maj. Sonnie Bates filed suit in U.S. District Court for the District of Columbia May 3 asking that the controversial vaccine be declared an experimental drug and thus prohibited without servicemembers’ informed consent.
Named as defendants in the suit are Defense Secretary Donald Rumsfeld, Health and Human Services Secretary Tommy Thompson, and Bernard A. Schwetz, the Food and Drug Administration’s acting principal deputy commissioner. Also named is BioPort, Inc., the Michigan company that is the vaccine’s sole manufacturer.
“The substantive changes in the way the vaccine is used and the purpose for which it is used render the vaccine an IND [investigational new drug] under current federal law,” said John J. Michels Jr., an attorney for the plaintiffs. “As an IND, the vaccine may not be administered to service members without their informed consent. It is patently illegal.”
There’s never been a lawsuit specifically challenging the FDA’s lawful role in the program.
· Mark Zaid
“There’s never been a lawsuit specifically challenging
the FDA’s lawful role in the program,” said Mark Zaid,
an attorney for one of the plaintiffs.
The Pentagon and BioPort, seeking FDA approval for use of the
vaccine against aerosolized anthrax, filed an IND application
in 1996 which is still pending. In the meantime, the DoD has inoculated
more than 500,000 servicemembers in its Anthrax Vaccination Immunization
Program (AVIP).
The vaccine was never approved for mass inoculation to prevent pulmonary anthrax.
· Dr. John Buck
“The vaccine was never approved for mass inoculation to prevent
pulmonary anthrax,” Buck told The Stars and Stripes. “It
should be considered investigational. Our servicemen deserve to
be told the risks and potential benefits, yet ultimately be given
the choice. Operationally, it makes sense to have a mandatory
program to vaccinate all the troops to ensure maximum survivability,
but legally and ethically I believe this encroaches on their rights
as citizens and human beings.
“Medicine is founded on three things—science, trust and patients’ rights. I feel the mandatory nature of the [immunization program] violates all three of those.”
The DoD says the vaccine is intended to protect servicemembers and civilian contractors from exposure to airborne anthrax spores. But the lawsuit contends that the FDA has never approved the vaccine for this use.
Mark Ellengold, deputy director of the FDA’s Center for Biologics Evaluation and Research, said the agency approved the anthrax vaccine for “general” use years ago. “The dispute arises because the labeling approved says ‘for prevention of anthrax’ and doesn’t specify anthrax via skin, inhalation, food or whatever,” he said.
The lawsuit refers to a 1994 Senate Veterans Affairs Committee report that concluded that the vaccine could not be expected to protect troops against airborne anthrax and therefore should be considered experimental.
Unfortunately, when anthrax is used as a biological weapon, it is likely to be aerosolized and thus inhaled. Therefore, the efficacy of the vaccine against biological warfare is unknown.
· VA Committee report
“Unfortunately, when anthrax is used as a biological weapon,
it is likely to be aerosolized and thus inhaled,” the report
said. “Therefore, the efficacy of the vaccine against biological
warfare is unknown. The vaccine should be considered investigational
when used as a protection against biological warfare.”
When Air Force pilot Bates refused the anthrax vaccine at Dover
Air Force Base, Del., in November 1999, he chose to end his 14-year
career to avoid a court-martial. He was given a general discharge
under honorable conditions in March 2000 and ordered to pay a
fine.
Buck, who refused the vaccine in January, is scheduled to be court-martialed
at Keesler Air Force Base, Miss., in September.
The Pentagon says its goal is to inoculate all 2.4 million active
and reserve troops by 2006. The shots are protection against the
bacterium that the DoD believes North Korea, Iraq and Iran may
be capable of producing. The proposed defense budget this year
includes $52 million to stockpile drugs for use in the event of
a bio-terrorist attack. The DoD reportedly has enough vaccine
to last until September of this year.
“As every day goes by, the AVIP continues to ruin the
lives of dedicated servicemembers and their families,” said
Zaid. “It is time for this program to be terminated. I hope
this litigation will open the eyes of the right people at the
Pentagon who will now conclude, ‘enough is enough, let it
end.’”
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Last revised: March 2004