Anthrax Vaccine Manufacturer Battles Suit
Dave Eberhart, NewsMax.com
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.
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.
