Why anthrax vaccine was & is not safe, effective or properly approved - ...

[Guest guest]

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 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=2\

407777 & dopt=Abstract ) published by Infectious Disease Clinics of North America

in March 1990 Army Doctors / Colonels Takafuji and 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

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. 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. ph 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

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.”

GAO confirms problems: In the April 1999 GAO Report T-NSIAD-99-148 (

http://www.gao.gov/cgi-bin/getrpt?GAO/T-NSIAD-99-226 ) confirmed that the

“long-term safety of the vaccine has not yet been studied,” that the “vaccine

and the manufacturing process (was) changed,” that " the ingredients used to make

anthrax vaccine were changed from the original vaccine,” and that “Prior to the

time of licensing, no human efficacy testing of the MDPH vaccine was performed. "

IOM confirmed safety problems: On March 30, 2000, the Institute of Medicine

(IOM) published “A Letter Report Assessment of the Safety of the Anthrax Vaccine

( http://newton.nap.edu/html/anthrax_vaccine/ ) " concluding, “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. "

Sole Congressional report confirmed problems: House Report 106-556 (

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_reports & docid\

=f:hr556.106 ) on April 3rd, 2000, titled “Unproven Force Protection,”

recommended suspension of the AVIP due to its “experimental” status. The

Committee determined, " While an improved vaccine is being developed, use of the

current anthrax vaccine for force protection against biological warfare should

be considered experimental and undertaken only pursuant to FDA regulations

governing investigational testing for a new indication. "

Presidential Candidate W. Bush empathized with the troops: In US

Medicine in September of 2000 candidate President Bush empathized with the

troops that “The Defense Department’s Anthrax Immunization Program has raised

numerous health concerns and caused fear among the individuals whose lives it

touches. I don't feel the current administration’s anthrax immunization program

has taken into account the effect of this program on the soldiers in our

military and their families. Under my administration, soldiers and their

families will be taken into consideration.” Senator McCain concurred, stating

in the San Diego Union Tribune in February 2000 that " I think that there should

be a pause. I think that they have not done the job in educating the members of

the military, and ... right now members of the armed services, the Guard and

reserves are not accepting it. " Hadley, Bush's Assistant for National

Security Affaires, confirmed the same on PBS NewsHour in Sept. 2000 (

http://www.pbs.org/newshour/forum/september00/military6.html ) stating, " The

vaccination program is a very serious issue. Maintaining the trust and

confidence of our men and women in uniform is critical to the future of our

armed forces. Some months ago, Governor Bush called for the Commander-in-Chief

and our military leaders to be very mindful of the concerns of our men and women

in uniform and their families about the vaccine, and called for the government

to do more to address their concerns. Hopefully the [Clinton] administration

will respond. "

Senate Majority Leader, a doctor, criticizes the anthrax vaccine: Sen. Bill

First criticized the vaccine on CNN in December 2001 (

http://www.cnn.com/2001/US/12/18/anthrax/index.html ) stating, " The vaccine is a

dated vaccine, it's an old vaccine. There are very real and potentially serious

side effects from the vaccine and anyone who elects to receive the vaccine needs

to be made aware of that. I do not recommend widespread inoculation for people

with the vaccine in the Hart Building ...There are too many side effects and if

there is limited chance of exposure the side effects would far outweigh any

potential advantage. "

Court rulings confirm illegality of mandatory anthrax inoculations: In December

2003 (http://www.dcd.uscourts.gov/03-707a.pdf ) and October 2004 (

http://www.dcd.uscourts.gov/Opinions/2004/Sullivan/03-707c.pdf ) the Federal

Court Rulings confirmed that " The involuntary anthrax vaccination program, as

applied to all persons, is rendered illegal absent informed consent or a

Presidential waiver. " In February 2006 the DC Federal Appeals Court declined to

vacate or overturn the ruling that the anthrax vaccine was illegal, despite

FDA's attempt to fix the paperwork and re-license the vaccine in December 2005.

GAO confirms vaccine problems remain: Via testimony in report GAO-06-756T (

http://www.gao.gov/new.items/d06756t.pdf ) the Congressional watchdog agency

continued to question the " long-term and short-term safety of the vaccine,

including gender differences; and the vaccine’s efficacy. " GAO again confirmed

that the " long-term safety of the licensed vaccine has not been studied, " and

that the efficacy of the vaccine for DoD's intended use against inhaled anthrax

" may not be extrapolated to humans. "

DoD Press and Courts attempt to rewrite the history of the anthrax vaccine: DoD

begins misinformation campaign to negate the importance of Federal Court

decisions, which previously confirmed the anthrax vaccine program was illegal.

Pentagon spokesperson claims, " No judicial judgment has declared such orders to

have been unlawful ( http://www.militaryproject.org/docs/vol4/GI ), " [special

4J1 Interview With The Resistance.doc] which is a patent falsity.

Additionally, military judges at the Court of Appeals for the Armed Forces rule

( http://www.armfor.uscourts.gov/opinions/2006Term/04-0246.pdf ) that the DoD

presumed the order to be legal previously. The judges refuse to reverse

previous court-martials, while omitting the finding of fact and law that the

anthrax vaccine program was declared illegal prior to the FDA's December 2005

flawed licensure.

Bottomline: The fundamental facts remain unaltered (

http://www.anthraxvaccine.org/ ), despite DoD's attempt to change the history

of the anthrax vaccine. The vaccine, in DoD's own words, is or was

unsatisfactory, inadequate, highly reactive, of limited effectiveness, and

therefore was experimental / investigational. It is academic that the anthrax

vaccine was illegal to mandate, and that DoD cannot erase their previous

intellectually honest criticisms (

https://www.hsdl.org/homesec/docs/legis/nps01-121103-07.pdf ). The new license,

for the same old vaccine, remains improper because the legally required clinical

trials never occurred. DoD's intended use of the vaccine for inhaled anthrax

remains unproven according to GAO testimony, and therefore the mandatory order

remains illegal. FDA's continued failures to properly regulate only complicate

the situation. DoD actions with respect to the anthrax vaccine violate the

armed forces' honor codes ( http://www.military-biodefensevaccines.org/ ), core

values (http://www.dallasnw.quik.com/cyberella/index.htm ), oath of office

(http://www.avip2001.net/ ) and the basic trust Americans require (

/ ).

--------------------------------------------------------------------------------

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 (footnote 10).

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 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=2\

407777 & dopt=Abstract ) published by Infectious Disease Clinics of North America

in March 1990 Army Doctors / Colonels Takafuji and 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

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. 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. ph 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

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.

GAO confirms problems: In the April 1999 GAO Report T-NSIAD-99-148 (

http://www.gao.gov/cgi-bin/getrpt?GAO/T-NSIAD-99-226 ) confirmed that the

long-term safety of the vaccine has not yet been studied, that the " vaccine and

the manufacturing process (was) changed, " that " the ingredients used to make

anthrax vaccine were changed from the original vaccine, and that, Prior to the

time of licensing, no human efficacy testing of the MDPH vaccine was performed. "

IOM confirmed safety problems: On March 30, 2000, the Institute of Medicine

(IOM) published A Letter Report Assessment of the Safety of the Anthrax Vaccine

( http://newton.nap.edu/html/anthrax_vaccine/ ) concluding, 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. "

Sole Congressional report confirmed problems: House Report 106-556 (

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_reports & docid\

=f:hr556.106 ) on April 3rd, 2000, titled Unproven Force Protection, recommended

suspension of the AVIP due to its experimental status. The Committee determined,

" While an improved vaccine is being developed, use of the current anthrax

vaccine for force protection against biological warfare should be considered

experimental and undertaken only pursuant to FDA regulations governing

investigational testing for a new indication. "

Presidential Candidate W. Bush empathized with the troops: In US

Medicine in September of 2000 candidate President Bush empathized with the

troops that " The Defense Department's Anthrax Immunization Program has raised

numerous health concerns and caused fear among the individuals whose lives it

touches. I don't feel the current administration's anthrax immunization program

has taken into account the effect of this program on the soldiers in our

military and their families. Under my administration, soldiers and their

families will be taken into consideration. " Senator McCain concurred, stating

in the San Diego Union Tribune in February 2000 that " I think that there should

be a pause. I think that they have not done the job in educating the members of

the military, and ... right now members of the armed services, the Guard and

reserves are not accepting it. " Hadley, Bush's Assistant for National

Security Affaires, confirmed the same on PBS NewsHour in Sept. 2000 (

http://www.pbs.org/newshour/forum/september00/military6.html ) stating, " The

vaccination program is a very serious issue. Maintaining the trust and

confidence of our men and women in uniform is critical to the future of our

armed forces. Some months ago, Governor Bush called for the Commander-in-Chief

and our military leaders to be very mindful of the concerns of our men and women

in uniform and their families about the vaccine, and called for the government

to do more to address their concerns. Hopefully the [Clinton] administration

will respond. "

Senate Majority Leader, a doctor, criticizes the anthrax vaccine: Sen. Bill

First criticized the vaccine on CNN in December 2001 (

http://www.cnn.com/2001/US/12/18/anthrax/index.html ) stating, " The vaccine is a

dated vaccine, it's an old vaccine. There are very real and potentially serious

side effects from the vaccine and anyone who elects to receive the vaccine needs

to be made aware of that. I do not recommend widespread inoculation for people

with the vaccine in the Hart Building ...There are too many side effects and if

there is limited chance of exposure the side effects would far outweigh any

potential advantage. "

Court rulings confirm illegality of mandatory anthrax inoculations: In December

2003 ( http://www.dcd.uscourts.gov/03-707a.pdf ) and October 2004 (

http://www.dcd.uscourts.gov/Opinions/2004/Sullivan/03-707c.pdf ) the Federal

Court Rulings confirmed that " The involuntary anthrax vaccination program, as

applied to all persons, is rendered illegal absent informed consent or a

Presidential waiver. " In February 2006 the DC Federal Appeals Court declined to

vacate or overturn the ruling that the anthrax vaccine was illegal, despite

FDA's attempt to fix the paperwork and re-license the vaccine in December 2005.

GAO confirms vaccine problems remain: Via testimony in report GAO-06-756T (

http://www.gao.gov/new.items/d06756t.pdf ) the Congressional watchdog agency

continued to question the " long-term and short-term safety of the vaccine,

including gender differences; and the vaccine's efficacy. " GAO again confirmed

that the " long-term safety of the licensed vaccine has not been studied, " and

that the efficacy of the vaccine for DoD's intended use against inhaled anthrax

" may not be extrapolated to humans. "

DoD Press and Courts attempt to rewrite the history of the anthrax vaccine: DoD

begins misinformation campaign to negate the importance of Federal Court

decisions, which previously confirmed the anthrax vaccine program was illegal.

Pentagon spokesperson claims, " No judicial judgment has declared such orders to

have been unlawful, " ( http://www.militaryproject.org/docs/vol4/GI ( [special

4J1 Interview With The Resistance.doc] which is a patent falsity.

Additionally, military judges at the Court of Appeals for the Armed Forces rule

( http://www.armfor.uscourts.gov/opinions/2006Term/04-0246.pdf ) that the DoD

presumed the order to be legal previously. The judges refuse to reverse

previous court-martials, while omitting the finding of fact and law that the

anthrax vaccine program was declared illegal prior to the FDA's December 2005

flawed licensure.

Bottomline: The fundamental facts remain unaltered (

http://www.anthraxvaccine.org/ ), despite DoD's attempt to change the history of

the anthrax vaccine. The vaccine, in DoD's own words, is or was unsatisfactory,

inadequate, highly reactive, of limited effectiveness, and therefore was

experimental / investigational. It is academic that the anthrax vaccine was

illegal to mandate, and that DoD cannot erase their previous intellectually

honest criticisms ( https://www.hsdl.org/homesec/docs/legis/nps01-121103-07.pdf

). The new license, for the same old vaccine, remains improper because the

legally required clinical trials never occurred. DoD's intended use of the

vaccine for inhaled anthrax remains unproven according to GAO testimony, and

therefore the mandatory order remains illegal. FDA's continued failures to

properly regulate only complicate the situation. DoD actions with respect to

the anthrax vaccine violate the armed forces' honor codes (

http://www.military-biodefensevaccines.org/ ), core values (

http://www.dallasnw.quik.com/cyberella/index.htm ), oath of office (

http://www.avip2001.net/ ) and the basic trust Americans require (

/ ).

[Guest guest]

http://groups.msn.com/oddsnends/anthraxshots.msnw

I added the first part of this to my 'oddsnends' web group

Hoping it helps spread the word ... a little

I think most vaccinations are counter-productive anyway

Gretchen <anna_nim@...> wrote:

GAO confirms problems: In the April 1999 GAO Report T-NSIAD-99-148 (

http://www.gao.gov/cgi-bin/getrpt?GAO/T-NSIAD-99-226 ) confirmed that the

“long-term safety of the vaccine has not yet been studied,” that the “vaccine

and the manufacturing process (was) changed,” that " the ingredients used to make

anthrax vaccine were changed from the original vaccine,” and that “Prior to the

time of licensing, no human efficacy testing of the MDPH vaccine was performed. "

SNIP