Dave Eberhart, NewsMax
 

Perennial critics of the Department of Defense’s anthrax vaccination program point to what they say is a troubling déjà vu of DoD pronouncements regarding the safety of the controversial vaccine, which is going back on the shelves after having been stalled for years owing to failure of the government’s manufacturer, BioPort of Lansing, Mich., to measure up to Federal Pure Food and Drug Administration requirements.

Late last month a DoD spokesman announced, "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 critics such as Air National Guard Major Thomas L. Rempfer of West Suffield, Connecticut, tell NewsMax that the old wolf is 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, says Rempfer. And there was good reason for the directive, as he explains: "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."

Rempfer now questions,"Is it ethical to re-mandate the old vaccine despite these revelations and the President’s directive?”

Rempfer takes note that last month’s DoD vaccine program revival announcement concedes that FDA approved antibiotics have been shown to be effective in treating cases of inhaled anthrax, thereby negating the need to vaccinate civilians.

"The anthrax vaccine program, previously hailed by Defense Department officials as the 'centerpiece' of biological defense and as crucial 'body armor,' has now been relegated as unnecessary for civilians,” says Rempfer. He questions 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.”

Unresolved Issues

Rempfer’s reference to unresolved issues includes the issue of the many servicemen and servicewomen who were either court-martialed, administratively punished or who lost their careers for refusing to take the vaccine the first time around. Additionally, hundreds of highly trained pilots and aircrew 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 the Gulf War.

Rempfer and other critics maintain that what was promised in December 1997 by then Secretary of Defense William Cohen has yet to be fully realized. At that time Cohen said, "I made implementation of the program contingent on the successful completion of four conditions: supplemental testing of the vaccine; assured tracking of immunizations; approved operational and communications plans; and review of the health and medical aspects of the program by an independent expert.”

Rempfer suggests that any proper review of the health and medical aspects of the vaccine was precluded by the DoD’s lack of proper record keeping as to which soldier got which dose from which lot, etc.

"The Defense Department has simply replaced [Cohen’s] 4-point review used in launching the original anthrax vaccine program implementation in 1998 with an Institute of Medicine report, which they also funded, to justify the resumption of the program in 2002.

"The previous 1998 review was by an OB/GYN with no expertise in anthrax, who applauded the U.S. Army for assisting in the preparation of his report. The old report is now replaced with a [new] report, similarly applauding U.S. Army officials for their assistance while omitting all dissenting views.”

Furthermore, Rempfer argues, it is difficult to navigate from 1998 to the present. "The previous IOM report two years earlier objectively concluded, ‘There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine... The committee concludes that in the peer-reviewed literature there is inadequate/insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse health outcomes.’”

Rempfer wonders what has transpired by the spring of 2002 that scientifically buttresses a new report concluding the vaccine is "reasonably safe.”

He further says that the latest study is based on animal studies that do not meet the legal standard for vaccine licensure.

Rempfer sees as the best case scenario for what the DoD is doing this time around: "They’re merely announcing minimal use of the new vaccine, while responsibly developing a safer one -- to preclude admissions of medical liability and legal misconduct.”

The Air Guard officer concludes, "Four and one half years of serious risk analysis and debate have transpired, yet the script is almost identical to the 1997 pronouncements. Is the Defense Department resuming a program with the same ‘boilerplate’ with which it began without acknowledging past errors? Is this simply a continued facade of force protection to save face?”

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