Air Force Doctor,
Former Pilot Sue to Have Anthrax Vaccine Declared Experimental
by Dave Eberhart
Stars and Stripes
May
4, 2001
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.'"
Source:
http://www.stripes.com/servlet/News/ViewArticle?articleId=100037795&buildId=-1&frontpageId=100037763