President George W. Bush
Vice-President Richard B. Cheney
Secretary of Health and Human Services Tommy G. Thompson
May 20, 2002
The Honorable Donald Rumsfeld
Secretary of Defense
1000 Defense Pentagon
Washington, DC, 20301-1000
Dear Secretary Rumsfeld:
We are submitting this letter to express our profound concern
and opposition to the likely resumption of the Pentagon's use
of Bioport Corporation's anthrax vaccine. We, including many retired,
former, and currently-serving service members and their families,
are most deeply troubled by the fact that anthrax vaccine recipients
have already been severely harmed (and more will be including
more deaths) from the use of this vaccine which has yet to be
shown effective in providing desired protection.
The prospect that the Bioport vaccine will be used on troops in spite of its failed record arises even in the midst of:
Even more than a year after the AVIP ran out of usable inventory, concerned organizations are still hearing nearly every week from people who are contacting them for the first time about their inexplicable health predicament or mistreatment associated with the shot - tough marines who enforced the policy and are now debilitated from following orders; a dedicated security policewoman whose entire body became bloated and covered with a rash and who is now diagnosed with MS; and a naval enlistee who went AWOL for 8 months to avoid the shot and who served 6 months in the brig next to an individual serving only 30 days for being AWOL for 14 years. Please pardon the frankness, but hasn't this shot done more than enough damage already? It defies all logic that such a program could possibly be up for renewal.
Ever since the FDA illegally permitted the experimental use of this shot for supposed protection against inhaled anthrax in the Gulf War, the vaccine has been a desecration of the sacrifices made by thousands of Americans in WWII to establish the Nuremberg Code. Even back then, however, a legacy of military medical abuses began in earnest as the U. S. government and Army officials at Ft Detrick excused Japanese Unit 731 human biowarfare experimentation in exchange for data from those experiments. And just this year, the Pentagon admitted perhaps one of its worst-ever abuses involving the spraying of Vietnam-era military members on tugboats in the Mississippi River with live biological agents under Project Shad. What will soldiers think now after last fall's anthrax attacks? That they have been left unprotected during the current AVIP hiatus only to need revaccination against threats from Ft Detrick? This contemplated reuse of the anthrax shot is another weak link in the DoD chain of criminal medicine, and this chain must be broken!
While officials of other companies (such as Isratex) were fined, jailed, and put out of business in recent years for producing defective biodefense products and jeopardizing the health of service members, Bioport received a new tax lease on life each time it committed identical contractual violations. As one of the nation's highest-level public servants, citizens expect you to stand against such corruption, especially as Bioport's product has actually produced measurable and immeasurable harm to our military.
You yourself said publicly, shortly after 9/11, that this outfit had some problems and needed a closer look. There is no evidence that a closer look has been taken. This outfit continues to run against the legal norms of sound vaccine production policy. Assessments to the contrary whitewash the facts, especially the FDA's approval of Bioport's filter changes ten years after they were first made without notification to the FDA, but with Bioport and Pentagon knowledge that those changes were associated with greater reaction rates and a 100 fold increase in potency. It is incomprehensible that the FDA would make such approval without conducting a study of the health effects of these changes on our military.
The Armed Forces and public opinion both function as part of our national immune system and that system has registered its vehement reaction against the anthrax vaccine in the form of countless negative media stories, legal actions, and grassroots protests. Just because authorities use their institutional power to sweep the vaccine's cancerous influence under the rug doesn't mean that influence isn't still metastasizing even though the AVIP itself is currently in "remission." In fact, postal workers and the general public now in a position to be recipients of this dangerous vaccine are beginning to stir in ways that could make Britain's public anger over the Mad Cow disease fiasco seem mild by comparison. You have the power to stop the harmful impact of this needless needle now.
Yet, if you allow this program to restart, you will, like government leaders in successive administrations, be ignoring, the will of the vast majority of Americans (polls show up to 90% of the general populace) who oppose the forced use upon our military of this product. After the anthrax vaccine injuries in the Gulf War and from the past administration, the AVIP would now be an inexcusable third strike against the morale and welfare of service members and their families. We believe this country can bear no further suffering from an illegally-used vaccine that will inevitably produce more injuries as well as public reactions of even greater frequency and severity.
Also, the recent Institute of Medicine study presents particular problems as justification for resuming the AVIP. That study was not balanced by funding organizations that had no stake in the report's outcome or that opposed the program on various grounds. The IOM study is now the third Pentagon attempt to inadequately justify the AVIP with "outside experts" - the first being the Dr. Joseph/Dr. Friedman 3/97 memos to circumvent the FDA's IND process requirement for approving the vaccine as protective against inhaled anthrax; the second being the program "approval" by gynecologist Dr. Burrow who was unqualified in either biowarfare or vaccine matters. These facts should be cause for deeply discounting the IOM study recommendations.
The only conceivable basis for continuing this program would be on a totally voluntary basis with each member being fully informed about the vaccine's risks - and that means reading aloud to vaccine recipients all the product insert describing the 60 or so reported types of reactions along with each of the six associated fatalities and their conditions at death.
Such a voluntary offering should not occur, however, as long as the FDA final ruling has not been issued and the product remains adulterated by unauthorized process changes. There can be no justification, no matter how supposedly great the threat, for allowing the distribution into public commerce of a product that does not conform to basic legal and manufacturing standards. Even at D-Day, this nation's civilian and military leadership decided against administering a botulism vaccine to protect against likely Nazi possession of this bioweapon because the vaccine's serious side effects could impair soldier's ability to fight. And our nation's first president halted the smallpox inoculation when he witnessed the health havoc it was creating on his troops. Why is it that today, against a threat that isn't even contagious, the Pentagon would entertain taking such unjustifiably high risks with service member health?
One other condition should exist before a single dose of vaccine is administered again - each lot must be tested separately for the illegal presence of squalene using the more sensitive gas chromatography with flame ionization process by which the FDA discovered squalene in the vaccine. The FDA has the power to conduct such additional testing and has so indicated during the GAO squalene investigations. Any lot failing this test should be destroyed, as well as all eight lots sampled by the FDA process that were found to contain squalene that are still in the inventory and declared by the FDA's Mark Elengold in a July 2001 IOM meeting to be useful in case of a national emergency. Additionally, the three lots not identified by lot number in the 3/20/00 Melinda K. Plaisier HHS letter to Representative Jack Metcalf should be made public along with the level of squalene parts per billion for each of those lot numbers as was done with the other five squalene-contaminated lots. After months and years of Pentagon denial about its use of squalene, it is no longer sufficient simply to take the word of government officials that this long-known, arthritis-triggering substance is not in the shot.
Finally, and perhaps most objectionable of all, is DoD's
announcement last Friday that shots may resume only for those
at risk, and it wouldn't be disclosed who received the new shots
for "security reasons." This idea is a no-win situation
for service members who have been told they will die without the
shot, who may not now know if they are even being given this shot,
and who may be punished for disclosing illness associated with
the shot. How will Guard and Reserve members deal with shot reactions
that affect their civilian employment? How can they possibly be
diagnosed and treated properly if they can't even discuss their
condition or know if and when they received an anthrax injection?
Thinking of a secret vaccine as a deterrent because enemies won't
know which soldiers are vaccinated is an exercise in self-delusion
and exhibits a cult-like tenacity to the false doctrine of vaccine
salvation which is disputed by none other than Bill Patrick and
Ken Alibek who say shots are too easy to defeat. But the worst
part about this idea is that the Pentagon would have the unmitigated
gall to reinstitute the shot on the very same basis that so outraged
service members, their relatives, and friends in the Gulf War
where shot records were "classified," not recorded,
or lost. Is it really possible that Pentagon policymakers think
they can just fool all the soldiers all the time? We are fully
committed to opposing by every legal means necessary such a provision
that puts this vaccine beyond adequate public and Congressional
scrutiny.
The nation needs you to prevent a very avoidable and significant
collapse of confidence in government. We are counting on you and
praying for you to decide against the unnecessary risks posed
by this shot, and we ask you to decide for the long-term health
and goodwill of current and future citizens and their families
who serve in our nation's armed forces.
Sincerely,
Redmond H. Handy, President
Kathryn D. Hubbell, President, Executive Director, Anthrax Vaccine Network
Stephen L. Robinson, National Gulf War Resource Center
cy:
President George W. Bush
Vice-President Richard B. Cheney
Secretary of Health and Human Services Tommy G. Thompson
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Last revised: May 2002