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

[Guest guest]

(illegal - see below) Mandatory anthrax vaccinations to begin OCTOBER 2006

" Dear Medical Reporter:

This is to invite you to a telephone media roundtable with Dr.

Winkenwerder, Jr., Assistant Secretary of Defense for Health Affairs, on

Monday, October 16, from 2:30 to 3:30 p.m. est. At that time, Dr.

Winkenwerder will discuss the department's resumption of the mandatory

Anthrax Vaccine Immunization Program (AVIP) for military personnel,

emergency-essential DoD civilians and contractors, based on geographic

areas or roles. DoD anthrax immunizations will be administered consistent

with the FDA-licensed

dose schedule and current standards for medical practice.

Terry D. , APR

Office of Communications

Assistant Secretary of Defense (Health Affairs) http://www.ha.osd.mil "

It is therefore time to develop strategies to fight this in the media, the

courts and in outreach to Congress. I also feel we need to do some

anti-recruitment work around the mandatory vaccinations and their side

effects. It looks like it will be announced on Monday.

Meryl Nass, MD

From Gretchen listowner................. " 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 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_ui

ds=2407777 & 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 & d

ocid=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 (

/ ).

Gretchen

Our Anthrax information web site: http://www.dallasnw.quik.com/cyberella/

/files/VAERS.pdf

DESTROY QUARANTINED VACCINE:

http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662 & amp;amp;amp;amp;1

PETITION TO OVERTURN/REPEAL FERES DOCTRINE

http://www.petitiononline.com/fd1950/petition.html

To visit Dr. Meryl Nass's web site, go to: http://www.anthraxvaccine.org

Also visit: Anthrax Vaccine Benefit vs Risk: http://www.avip2001.net AND

http://www.MajorBates.com/

Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

Sgt. Larson's story:

http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

http://www.avip2001.net/CongressionalTestimony.htm

Tom Heemstra's new book -

http://www.anthraxadeadlyshotinthedark.com/index.html

Contact list owner: Gretchen at: anna_nim@...

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

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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