Drugs & Vaccines will only be tested on animals for human use!

[Guest guest]

-

" Ingri Cassel " <vaclib

Tuesday, January 22, 2002 11:12 PM

H.R. 3448 --Public Hlth Security & Bioterrorism Response Act

 

 

> Dear Members and Friends -

> It sure is coming down hard and fast after 9/11. The MSEHPA appears to be

> just the tip of the iceburg:

>

> H.R. 3448 and the political agenda behind DoD/HHS for animal

> efficacy tests

> ISSUE: Rationale for DoD/HHS desire to amend the Food, Drug, and Cosmetic

Act

> to allow only animal testing for efficacy for biodefense drug/vaccine

> licensure

>

> A bill, called the " Public Health Security and Bioterrorism Response Act

of

> 2001 " , was passed in December by both the House (H.R. 3448) and the Senate

> (S. Amdt. 2692) without any debate. This bill contains many questionable

> provisions. Perhaps the most objectionable is a mandate for FDA to

finalize

> and implement a 1999 FDA Notice of Proposed Rulemaking (NPRM) that would

> allow solely animal testing for the full licensure of drugs and vaccines

> used for biological defense. To read it, SEE:

> <A HREF= " http://www.fda.gov/cber/rules/lethtox.pdf " >

> http://www.fda.gov/cber/rules/lethtox.pdf</A >

>

> Current law, passed in 1962 in the wake of the Thalidomide disaster,

requires

> human efficacy trials for full licensure as " safe and effective " . This

change

> to the law will:

> -- Effectively weaken the 1962 Harris-Kefauver amendments to the Food,

> Drug and Cosmetic Act

> -- Neutralize a 1998 law that protects servicemember from experimental

> and investigational drugs/vaccines (10 USC 1107, also called the Byrd

> Amendment); and,

> -- Lower the political accountability for using what are now

> experimental drugs and vaccines in mandatory public health programs from

> elected officials to faceless bureaucrats.

> The important issue is that, as written, all of the science to justify

> licensure of what would under current law be experimental drugs can come

from

> the DoD and/or CDC, both of which has a vested interest in the outcome of

the

> clinical trials. Their staffs collaborate regularly and have the same

> bureaucratic agenda. Further, FDA is likely to compromise its regulatory

> oversight responsibility for drugs/vaccines it believes are vital to

national

> defense. They have done so with anthrax vaccine for over 30 years.

> The purpose of this legislation is purely political. These drugs/vaccines

can

> be used under current law -- BUT, only with informed consent -- which both

> HHS and DoD detests. H.R. 3448 allows DoD and CDC to mandate use of these

> products without informed consent because they would be " fully licensed "

as

> " safe and effective " by the FDA.

> Under current law DoD must seek a Presidential waiver to require mandatory

> use of experimental or investigational drugs/vaccines on servicemembers.

> HHS, under current law, must provide informed consent -- an inconvenience

> made apparent by all--too--inquisitive postal workers who have refused the

> DoD/BioPort anthrax vaccine based in CDC's refusal to provide FULL

informed

> consent about known adverse reactions. Under H.R. 3448 there would have

been

> no " experiment " and therefore no requirement for informed consent for

using

> anthrax vaccine on postal workers and Congressional staff.

> The HHS-sponsored " Model Law " currently being considered by the 50 States

> would strengthen the ability of civilian public health agencies to mandate

> biodefense vaccination -- but only with " fully licensed " products. H.R.

3448

> will insure this moniker -- a legal fig leaf vital to public health

> bureaucrats -- is applied to biodefense products HHS seeks to stockpile.

> The House version of H.R. 3448 allows 180 days after passage for FDA to

> finalize the 1999 proposed rule (NPRM). This would allow for public

comment

> and possibly Congressional hearings. The Senate version allows just 30

days

> for FDA to finalize the NPRM -- and basically no public debate.

> Given that neither of these bills was debated prior to passage, it is

> important that information about this change to the Food, Drug, and

Cosmetic

> Act be publicly vetted before the conference committee convenes when

Congress

> returns. If Congress won't debate the issue, the media and interest groups

> must.

> --------

----

> ----------

> ADD'L POINTS ON FDA'S October 5, 1999, NPRM:

> 1) The 2001 DoD Annual Report to Congress on CBW programs (we can send you

> relevant pages) acknowledged that FDA and DoD are working together to

amend

> the Code of Federal Regulations (i.e. the law) to allow animal efficacy

> studies for licensure of biowarfare drugs and vaccines. Several points:

> 2) Neither DoD nor CDC has ever been able to prove a correlate of immunity

> between animals and humans, meaning that efficacy proven in animals is

simply

> encouraging, but not scientifically significant -- or legally sufficient.

> 3 If DoD/CDC asserted such a correlate, their science should be subject to

> rigorous outside review by independent non-stakeholders.

> 4) If the law is amended, it should be done explicitly by Congress, not by

> administrative fiat by simply setting a deadline for a federal agency with

a

> vested interest to finalize their own proposed rule. Such a law, which

would

> amend the Food, Drug, and Cosmetic Act, should specifically forbid FDA

from

> considering research supporting licensure of any drug or vaccine from the

> primary stakeholders -- DoD and HHS -- without independent, non-government

> corroboration of the results.

> 5) The willingness of the FDA to comply with DoD's agenda has been noted

by

> Connecticut Attorney General Richard Blumenthal. He wrote to Secretary of

> Defense Rumsfeld last year stating:

> " In his very short letter, with a stroke of the pen, [FDA Lead Deputy

> Commissioner] Dr. Friedman wiped out ten years of DoD analysis and 25

years

> of FDA law designed to protect the safety and well being of the citizens

of

> the United States. There was no justification, legal, scientific or

otherwise

> for this action. "

> SEE: <A HREF= " http://www.cslib.org/attygenl/press/2001/health/dod1.htm " >

> http://www.cslib.org/attygenl/press/2001/health/dod1.htm</A>

> 6) Any amendment to the law should only allow animal tests for EFFICACY.

> Human SAFETY trials must still be required per the current law.

> 7) Any drug or vaccine licensed via this process should have an active

> monitoring program (vs. current passive VAERS system) that would quickly

> identify safety and efficacy problems. Such a monitoring system should be

> managed by a non-DoD and non-DHHS entity who would objectively report the

> truth, unlike the experience with the DoD anthrax vaccine in which DoD and

> HHS have colluded to deny chronic, multi-symptom autoimmune disorders.

> 8) A public policy debate, in Congress, is in order because the only

reason

> for amending the law to elevate these biowarfare defense drugs and

vaccines

> beyond experimental or investigational status to fully licensed status is

to:

> a) allow political cover for the government to mandate their use without

an

> Executive Order; and,

> b) to make it very difficult for victims of such drugs and vaccines to

> recover damages, and impossible for military servicemembers because of the

> Feres Doctrine.

> c) Avoid responsibility if another Thalidomide-type disaster occurs. Given

> this, why should the current law, passed after much debate in 1962 three

> years after the Thalidomide disaster, be changed?

>

> _______________

>

> Ingri Cassel, President

> Vaccination Liberation - Idaho Chapter

> P.O. Box 1444

> Coeur d'Alene, ID 83816

> (208)255-2307/ 765-8421

> vaclib

>

> www.vaclib.org

> " The Right to Know, The Freedom to Abstain "

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