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.”