DoD's Renewal of Anthrax Vaccine---comment

[Guest guest]

DoD's Renewal of Anthrax Vaccine Provokes Criticism

> From: Sheri Nakken <vaccineinfo@...>

> DoD's Renewal of Anthrax Vaccine

> Provokes Criticism

> 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 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' 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 Issue

>

> Rempfer's reference to unresolved issues include 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 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 US Army for assisting in the preparation of his report. The

> old report is now replaced with a [new] report, similarly applauding US 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? "