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Anthrax Vaccine
Manufacturer Battles Suit
Dave Eberhart,
NewsMax.com
Thursday, July 25, 2002
As the military ramps up its long-stalled next round of inoculations
for service members considered in harm’s way of bio-attack, former
Connecticut Air National Guard pilots Russ Dingle and Tom Rempfer are
pursuing a claim on behalf of the United States against BioPort Corp. of
Lansing, Mich., the sole American manufacturer of the anthrax vaccine,
alleging the drug manufacturer was responsible for the presentation of
false claims to the government.
The U.S. District Court for the Western District of Michigan was
scheduled Wednesday afternoon to hear oral argument on a motion to
dismiss filed by BioPort in U.S. ex rel. Dingle v. BioPort Corporation.
Dingle and Rempfer told NewsMax that the basis for their lawsuit
arises from their discovery that the anthrax vaccine sold after 1990 to
the U.S. government (principally for the involuntary inoculation of
military forces) was manufactured without conformity to the approved
limitations established by the Food and Drug Administration when it
licensed the controversial vaccine.
The two former military aviators, who resigned rather than submit to
the involuntary series of anthrax inoculations, focus in their complaint
on official findings of the General Accounting Office’s investigation of
BioPort that were made public last year.
The government report that was handed to investigative committees on
Capitol Hill included these findings:
"In the case of the anthrax vaccine, the Michigan facility did not
notify FDA of a number of changes made in the manufacturing process in
the early 1990s and no specific studies were undertaken to confirm that
vaccine quality was not affected.”
"FDA inspectors did not inspect the Michigan facility’s anthrax
production room until 1993. According to FDA, access was not granted
because its inspectors had not been vaccinated against anthrax. FDA
inspectors were able to perform some aspects of inspection — for
example, reviewing records — but not equipment and production.”
"The inspections that FDA ultimately was able to conduct over time
found a number of deficiencies, many of which were not corrected in a
timely manner. For example, the deficiencies that FDA identified it its
February 1998 inspection fell broadly into two categories: (1) those
that, although serious, might affect only one or a limited number of
batches that were produced when the deficiency was extant and (2) those
of a generic nature that could compromise the safety and efficacy of any
batch or all batches.”
Vaccine production was suspended after these findings.
Last month when announcing the return of the vaccination program, a
DoD spokesman said: "We have a vaccine that protects against anthrax
exposure. The vaccine is safe and effective. The Food and Drug
Administration approved the vaccine for use, and the FDA certified the
manufacturing facility that produces the vaccine. After a comprehensive
independent study, the National Academies of Science’s Institute of
Medicine fully endorsed the safety and effectiveness of the vaccine just
a few months ago in March.”
But perennial critics of the Department of Defense’s anthrax
vaccination program such as Dingle and Rempfer immediately pointed to
what they said was a troubling déjà vu of DoD pronouncements regarding
the controversial drug.
Rempfer of West Suffield, Conn., told NewsMax that the old wolf was
just being trotted out in a new ensemble of sheep’s clothing.
President Bush in the 2002 State of the Union address directed
development of a new anthrax vaccine, said Rempfer. And there was
good reason for the directive, he explained.
'Is It Ethical?'
"The old anthrax vaccine’s new product label lists up to 175 times
greater systemic adverse reaction rates, possible birth defects, and
deaths reportedly associated with the vaccine as of January of 2002. Is
it ethical to remandate the old vaccine despite these revelations and
the president’s directive?”
Rempfer said he questioned the wisdom of once again mandating "this
known inadequate and costly vaccine” as a "layer” of defense for
soldiers given no choice in the matter – "while outstanding legal and
'Gulf War Illness' issues remain unresolved.”
Rempfer’s reference is to unresolved issues includes the issue of the
many servicemen and servicewomen who were either court-martialed,
administratively punished or lost their careers for refusing to take the
vaccine the first time around. Hundreds of highly trained pilots and air
crewmen were lost from flight status. Also, the vaccine has been linked
to the mysterious "Gulf War Illness” that has plagued many of the
veterans of that war.
Dingle and Rempfer were forced to resign from their pilot positions
at the Connecticut Air National Guard in 1999 when their concerns as to
the safety, efficacy, necessity and legality of the military's AVIP
(Anthrax Vaccine Immunization Program) and the vaccine itself were not
addressed to their satisfaction.
After their resignations, Dingle and Rempfer testified before the
House of Representatives.
Read more on this subject in related Hot Topics:
Bioterrorism
Health
Issues
A product that might interest you:
"Living Terrors: Surviving the Coming Bioterrorist Catastrophe"
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