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FDA taking public comments on Anthrax Vaccine

 
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Zack
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PostPosted: Fri Jan 21, 2005 3:21 pm    Post subject: FDA taking public comments on Anthrax Vaccine Reply with quote

Hello Gary,
I just wanted to "post up" and remind everyone that the FDA, per court order, has reopened the public comment period on the Anthrax Vaccine. I would strongly suggest to everyone interrested in this issue to submit a comment(Docket No: 1980N-0208). Try to keep the sarcasm to a bare minimum, stick to the facts, and ask questions!

Any suggestions, Gary?
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madmmom
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PostPosted: Fri Jan 21, 2005 8:05 pm    Post subject: FDA COMMENTS Reply with quote

Could someone offer a link here that would allow for comments to reach the FDA during this 90 day period? It would save those of us without a lot of computer literacy precious time and energy! Thanks!
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zack
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PostPosted: Fri Jan 21, 2005 8:13 pm    Post subject: Reply with quote

Quote:
How to Comment: Submit a Comment on this Regulation

You may submit comments, identified by Docket No. 1980N-0208, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.

E-mail: fdadockets@oc.fda.gov.
Include Docket No. in the subject line of your e-mail message.

FAX: 301-827-6870.

Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed instructions on submitting comments and additional information on the process, see the Comments heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.



For more information: http://www.regulations.gov/AGCY_FOODANDDRUGADMINISTRATION.cfm



Here you go! I have already written and submitted my letter... if interrested, you can see it at

http://www.mvacpac.org/phpbb2/viewtopic.php?t=63


Also, www.milvacs.org is an excellent resource for anyone affected by this issue.
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Gary M - Author
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PostPosted: Sun Jan 23, 2005 4:58 pm    Post subject: Reply to Zack; RE: FDA Public Comments on Anthrax Vaccine Reply with quote

Dear Zack: I don't have any suggestions. People must decide for themselves what they want to say to the FDA about anthrax vaccine. This is, however, as good a time as any to remind everyone of the following facts some of which are from VACCINE A, and some I have have not reported anywhere before:

Quote:

(1) In 1998, the FDA joined an NIH Working Group to "fast track" the licensure of the "second generation" anthrax vaccine. At that time, both the U.S. and British versions of this vaccine contained squalene.

(2) In 1998, FDA officials told the Senate Veterans' Affairs Committee that if there is any squalene in anthrax vaccine, it was probably from "eggs," because some vaccine antigens are grown in eggs, which are rich in cholesterol, a closely related molecule.

(3) The FDA has known, at least since 1970 when the Division of Biologics Standards (DBS) first licensed Anthrax Vaccine Adsorbed, that Bacillus anthracis is grown in a special broth that contains no eggs.

(4) In 1999, squalene showed up in the military's anthrax vaccine supply. On 25 June 1999, to be precise, the FDA's Center for Biologics Evaluation and Research (CBER) found escalating concentrations of squalene in five lots of anthrax vaccine. Having initially declared all anthrax vaccine lots to be squalene-free, the military subcontractor, SRI, said it found squalene in a six anthrax vaccine lot.

(5) The FDA withheld this information. It did not disclose its findings to the public. A Congressman, Jack Metcalf, did that.

(6) When former Congressman Metcalf released the FDA data in September 2000, an FDA official, Mark Ellengold, told the House Goverment Reform Committee that that amounts were clinically insignificant and that the squalene was probably originated from the organism, Bacillus anthracis.

(7) If the FDA did not know that B. anthracis did not make squalene, it should have. The information is published and available from the National Library of Medicine, which is affiliated with the FDA's sister organization, the NIH.

(8) No lower threshold of safety for squalene has been established experimentally in animals or humans.

(9) In response to my Vanity Fair article, DoD's earlier incarnation of Facts on Squalene (posted on its website as recently as 2003) said there was no evidence that squalene stimulates the immune system. At that time, the Army had already been working on a vaccine adjuvant, MF59, whose sole immunogically-active ingredient is squalene, for nearly a decade.

(10) Initiating an immune response specific to squalene is, by virtue of the fact that squalene is a naturally occurring lipid molecule in the human body, also the initiation of an autoimmune response. In other words, triggering an immune response to squalene is a de fact autoimmune response.

(11) The Walter Reed Army Institute of Research has shown that you can initiate a specific immune response in animals to squalene (in the form of anit-squalene antibodies) by injecting the animals with squalene.

(12) Tulane University Medical School data shows that military personnel, who previously did not have anti-squalene antibodies, developed these antibodies, post-immunization, following injection with anthrax vaccine from one or more lots confirmed by the FDA's 1999 testing to contain squalene.

(13) In 2003, a British laboratory, SAL Ltd., found squalene in British-made anthrax vaccine in an amount comparable to that which was found in BioPort anthrax vaccine lot FAV 043. Britain has been working on its own version of the recombinant DNA anthrax vaccine, rPA102, since 1997-98. The British version incorporated a squalene-emulsion called the Ribi Adjuvant System (RAS).

(14) In March 2002, about a year before Operation Iraqi Freedom, DoD issued DoDD 3216.2 (DoDD stands for "Department of Defense Directive," which states that "the requirement for informed consent under paragraph 4.2. or subparagraph 4.2.1. may be waived by the Head of a DoD Component with respect to a specific research project to advance the development of a medical product necessary to the Armed Forces if the research project may directly benefit the subject and is carried out in accordance to all other applicable laws and regulations, including 21 CFR 50.24." [Italics mine]

(15) Title 21 CFR 50.24 concerns when exceptions can be made to the "Common Rule" a rule that requires informed consent for subjects of a medical experiment. This is part of what 21 CFR 50.24 states (IRB stands "for Insitutional Review Board"):

50.24 Exception from informed consent requirements for emergency research.

(a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:

1. The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
2. Obtaining informed consent is not feasible because:
i. The subjects will not be able to give their informed consent as a result of their medical condition;
ii. The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and
iii. There is no reasonable way to identify prospectively the individual likely to become eligible for participation in the clinical investigation.
3. Participation in the research holds out the prospect of direct benefit to the subjects because:
i. Subjects are facing a life-threatening situation that necessitates intervention;
ii. Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
iii. Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
4. The clinical investigation could not practicably be carried out without the waiver.
5. The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review.
6. The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with paragraph (a)(7)(v) of this section.

(16) Whether squalene comes from the organism, as FDA officials have suggested, or from fingerprints on glassware, as DoD officials now suggest, it is there. Testing by two U.S. labs and now a British lab have confirmed that.

(17) The FDA scientist who performed the GC/mass spec, flame ionization test on BioPort's anthrax vaccine, says he wore gloves (hence, no fingerprint contamination), and that FDA ran "blanks" (tubes filled with plain water). There was no squalene in the blanks.

(18) Tulane University Medical School's antibody data in military personnel, along with the medical records of those personnel showing the post-immunization onset of autoimmunity following inoculation with squalene-positive anthrax vaccine, is consistent with animal experiments showing the pathogenicity of injected squalene.

(19) Animals injected with squalene have developed rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus, sterile absesses and cysts. Military personnel injected with anthrax vacccine containing trace amounts of squalene have developed the identical diseases.

(20) In 2004, military personnel injected with anthrax vaccine for deployment to Iraq tested positive for anti-squalene antibodies.


These facts may or may not be worth bringing to the FDA's attention. I leave that decision to those individuals who plan to submit comments to the FDA on anthrax vaccine.

If you are thinking about submitting any comments on squalene, this particular experience I had with the FDA will be "food for thought." In 2000, I submitted more than 40 Freedom of Information Act (FOIA) requests based on the allegation that squalene had been deliberatedly incorporated into anthrax vaccine to further the development of the new anthrax vaccine.

By law, a government agency must acknowledge FOIA requests in writing. FDA refused to acknowledge my requests in writing. When I asked about them in a phone call, an FDA FOIA action officer said my requests had been "kicked upstairs" to HHS. HHS did not acknowledge receipt of my FOIA requests either. When I called HHS, a FOIA official said my requests have been "placed in a queue."

That was more than three years ago.

Sincerely,
Gary Matsumoto
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