Duke Law Journal - FRIENDLY FIRE & the Anthrax Vaccination Program

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Titled: " FRIENDLY FIRE: THE MANDATORY MILITARY ANTHRAX VACCINATION PROGRAM "

(Duke Law Journal, April 2001)

Worthy QUOTES:

" ...the adverse safety and efficacy information on the anthrax vaccine may be

the latest example of the Pentagon's deny-and-then-begrudgingly-admit policy.

Service members have a right to be concerned. "

" AVIP [Anthrax Vaccine Immunization Program] is analogous to 'friendly fire "

on American service members. Although the DOD [Department of Defense]

certainly is not intentionally trying to harm its troops, and AVIP was born

out of a genuine concern for American well-being and safety, the risks

associated with the vaccine are largely unknown. The DOD must stop the

friendly fire " shots " and regain service members' trust. "

'Connecticut Attorney General Blumenthal recently wrote a letter to

Secretary of Defense Rumsfeld urging him to make AVIP voluntary or

halt the program. Attorney General Blumenthal remarked in his letter,

" Unfortunately, and directly contrary to law, the [vaccine] is being

administered. ... In effect, the military is forcing its personnel to serve

as human guinea pigs for an unlicensed drug that has not been proven to be

safe or effective. " '

" The FDA [Food and Drug Administration] approval letters for the anthrax

vaccine are illusory. Although the 1997 and 1999 letters written by FDA

officials state that the vaccine is not an IND [investigational new Drug

Application], FDA regulations provide that statements made in the letters

have no legal effect on the IND status of the vaccine: "

" The DOD argues that the FDA letters validate its position that the AVA

[Anthrax Vaccine Absorbed] is not on IND status; however, since the letters

are not agency-approved, do not constitute official agency opinions, and fail

to take into account that the DOD is using AVA off-label, the letters are not

persuasive.  Thus, these letters have no legal bearing on the IND status of

the anthrax vaccine. ... The DOD also has referred consistently to AVA as an

IND in AVIP's files. "

" If Congress halts the program on its own, the DOD will not regain the trust

it has lost. The DOD should regain trust by making the system work: military

judges should examine the merits of the cases and make a fair judicial

evaluation, and the DOD should halt the program to conduct more research on

the long-term health effects and the vaccine's effectiveness. "

" The Pandora's box, however, may be open already. The House Government Reform

Committee held public hearings and concluded that AVIP should be suspended.

Documents widely available on the Committee's website conflict sharply with

the Pentagon's conclusions. This makes the decision for service members

incredibly difficult; one branch of government is assuring them the vaccine

is safe and effective, while a _{committee of another branch of government}

_{is expressing grave concern about the vaccine -- enough concern, in fact, to}

_{recommend the program be stopped altogether. The legality of the order is}

_{thus caught between the checks and balances of the executive and legislative}

_{branches. "}

_{Or is there a tie breaker in this system of " checks and balances " that can}

_{evaluate the conduct of the DOD, the FDA, and the manufacturer, Bioport, in}

_{this ethical dilemma?}

_{Major L. " Buzz " Rempfer}