FDA's incomplete rulemaking in 1985 rendered the anthrax vaccine
program illegal: In a Food and Drug Administration (FDA) Proposed Rule, 50
FR 51002. ( http://www.anthrax.mil/documents/library/fed_reg.pdf ) Dec.
13, 1985, the FDA published, but never finalized, a licensing rule for
the anthrax vaccine in the Federal Register based on an expert review
panel’s findings, which included the fact that the “Anthrax
vaccine…efficacy against inhalation anthrax is not well documented,” and that “No
meaningful assessment of its value against inhalation anthrax is
possible due to its low incidence,” and that “The vaccine manufactured by the
Michigan Department of Public Health has not been employed in a
controlled field trial.” The lack of a final anthrax vaccine rule led to the
declaration in 2004 that the program was illegal, though the court
never ruled on what it termed the numerous substantive challenges to FDA’s
Final Rule and Order (see footnote 10 [
http://www.anthrax.mil/documents/library/AnthraxSJtOrder_Op.pdf ] ).
DoD knew they need a modern vaccine: In 1985 the United States Army
submitted a “request for proposal” (
http://www.ct.gov/ag/lib/ag/press_releases/2001/health/fda.pdf ) to
solicit a new anthrax vaccine from the pharmaceutical industry. The Army
candidly discussed the limitations of the current vaccine with its high
adverse reaction rate and its questionable efficacy against different
strains of anthrax writing, “There is an operational requirement to
develop a safe and effective product which will protect US troops against
exposure from virulent strains of Bacillus anthracis. There is no
vaccine in current use which will safely and effectively protect military
personnel against exposure to this hazardous bacterial agent ... A
licensed vaccine against anthrax, which appears to afford some protection from
the disease, is currently available for human use...The vaccine is,
however, highly reactogenic, requires multiple boosters to maintain
immunity and may not be protective against all strains of the anthrax
bacillus.”
Once upon a time the DoD told the truth about the anthrax vaccine: In
1989 an Office of the Secretary of Defense (OSD) letter (
http://www.sskrplaw.com/vaccine/anthchrono.html ) to Senator John Glenn
reiterated the safety and efficacy problems with the anthrax vaccine,
saying “Current vaccines, particularly the anthrax vaccine, do not
readily lend themselves to use in mass troop immunization for a variety of
reasons: the requirement in many cases for multiple immunizations to
accomplish protective immunity, a higher than desirable rate of
reactogenicity, and, in some cases, lack of strong enough efficacy against
infection by the aerosol route of exposure.”
Once upon a time the DoD published the truth: In an article titled
“Military Immunizations Past, Present, and Future Prospects” (
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2407777&dopt=Abstract
) published by Infectious Disease Clinics of North America in March
1990 Army Doctors / Colonels Takafuji and Russell of Fort Detrick
described the anthrax vaccine as a: “Limited use vaccine...unlicensed
experimental vaccine.”
Congress knew there were problems: In a 1994 Senate Veteran Affair’s
Committee Staff Report, SR 103-97 (
http://www.gulfwarvets.com/senate.htm ), Major General Ronald Blanck
acknowledged a possible link between the anthrax vaccine and Gulf War
Illness to Committee investigators testifying, “Although anthrax vaccine
had been considered approved prior to the Persian Gulf War, it was
rarely used. Therefore, its safety, particularly when given to thousands of
soldiers in conjunction with other vaccines, is not well established.
Anthrax vaccine should continue to be considered as a potential cause
for undiagnosed illnesses in Persian Gulf military personnel because many
of the support troops received anthrax vaccine, and because the DoD
believes that the incidence of undiagnosed illnesses in support troops may
be higher than that in combat troops.”
Congress knew the vaccine was investigational: The Senate Committee
concluded in Senate Veterans Affairs Committee Staff Report 103-97
(http://www.gulfwarvets.com/senate.htm ) that “Records of anthrax
vaccinations are not suitable to evaluate safety...However, the vaccine’s
effectiveness against inhaled anthrax is unknown. Unfortunately, when
anthrax is used as a biological weapon, it is likely to be aerosolized and
thus inhaled. Therefore, the efficacy of the vaccine against biological
warfare is unknown…The vaccine should therefore be considered
investigational when used as a protection against biological warfare.”
Key scientists previously said the anthrax vaccine was unsatisfactory:
In the 1994 civilian medical textbook "Vaccines," Colonel (Dr.) Arthur
Friedlander, the Army's chief anthrax vaccine researcher at Ft.
Detrick, authored a chapter on the anthrax vaccine. The article was
co-authored by Dr. Phillip Brachman and edited by Dr. Stanley Plotkin, both
involved with the original study of the vaccine thirty years earlier. The
chapter acknowledged the shortcomings of the vaccine used for the AVIP,
including its high adverse reaction rates, plus noted, “The current
vaccine against anthrax is unsatisfactory for several reasons (
http://www.federalobserver.com/archive.php?aid=1326 ). The vaccine is
composed of an undefined crude culture of supernatant adsorbed to
aluminum hydroxide. There has been no quantification of the protective
antigen content of the vaccine or of any of the other constituents, so the
degree of purity is unknown. ... The undefined nature of the vaccine and
the presence of constituents that may be undesirable may account for
the level of reactogenicity observed. ... There is also evidence in
experimental animals that the vaccine may be less effective against some
strains of anthrax. Clearly a vaccine that is completely defined, that is
less reactogenic, and that requires one or two doses to produce
long-lasting immunity would be highly desirable.”
US Army tried to fix problems: In September 1995 the US Army developed
a plan at Fort Detrick to obtain FDA approval for the licensing of the
anthrax vaccine against aerosolized or inhalation anthrax. The plan’s
text included the fact that “This vaccine is not licensed for aerosol
exposure expected in a biological warfare environment (
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1447151 )."
Improper licensure: In a report prepared by the Joint Program Office
for Biological Defense (JPOBD) in December 1997, the DoD acknowledged,
“Anthrax and Smallpox are the only licensed vaccines that are useful for
the biological defense program, but they are not licensed for a
biological defense indication.”
Flawed testing: Mr. Joseph Little, a contracting officer for the
anthrax vaccine at the Pentagon, confirmed via email in May of 1999 that
results of the anthrax vaccine testing was “all over the board,” while
recommending they “suspend any further potency testing” or else the
results “must be reported to the FDA.”
DoD cover-up: Brigadier General Eddie Cain, in email exchanges with
Colonel John Wade, reference 29 APR 99 Congressional testimonies, said,
“…two key areas in which we came up flat were the GAO’s assertion that
#1, the anthrax vaccine licensed was NOT the one tested and #2, how can
DoD say that reported desert storm illnesses were not cause (sic) by
the anthrax vaccine when we have no record of who received the shots. If
we cannot answer these questions we (DoD & the Administration) are in
big time trouble.”
