FDA SILENT ON ‘ILLEGAL’ ANTHRAX VACCINE IN U.S. STUDY:

FDA is condoning the use in government employees of adulterated anthrax vaccine that CBER director Kathryn Zoon said 12/15 would not be licensed as safe and effective, according to former CBER/CDER compliance deputy director Sammie R. Young. Zoon told FDA Webview in a 12/17 e-mail that Young’s charges raise “several issues that can not be addressed in a short email. I’ll try to get back to you.” At a 12/15 public meeting at the National Academy of Sciences, Young says, he asked Zoon whether adulterated vaccine from old batches at BioPort Inc. would be used this week in studies involving Centers for Disease Control and/or postal employees “and in usual dancing around she really didn’t answer — the issue of 501(a)(2)(B) fell on deaf ears.”

[Sec. 501(a)(2)(B) of the federal Food, Drug & Cosmetic Act says that a drug will be deemed to be adulterated “if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”]

The Washington Post reported from the meeting that as many “as 3,000 people who were exposed to anthrax bacteria, including several hundred Washington postal employees and Capitol Hill workers, may be asked to take an anthrax vaccine this week because of fears they still harbor the deadly spores in their bodies.

“The vaccination program,” the Post continued, “would be intended for people recently exposed to anthrax-laden letters and who are considered at high risk even after taking antibiotics for 60 days. Although the anthrax vaccine is said to be safe, federal officials said any vaccinations would take place on an “experimental” basis because the vaccine has not received full government approval.”

In a 12/17 protest to National Institutes of Health director Anthony Fauci, Young cited his 29-year FDA career as an investigator and regulatory official to express concern over Zoon’s response and to assert: “I can assure you that reputable scientists do not administer ‘adulterate’" drugs to human beings in the U.S. and in general, scientists do not begin a study involving human subjects in which an experimental use drug is known to be sub-standard, and according to Dr. Zoon, CBER would not license the material representing that product (anthrax vaccine) as safe and effective.”

Young told Fauci in his letter that the meeting at the National Academy of Sciences seemed to confirm that there is no anthrax emergency “sufficient to warrant bypassing the human protection provisions of the Federal Food, Drug and Cosmetic Act.” He said the Department of Defense’s (DoD) controversial use of the BioPort vaccine on its own personnel had “failed to address the fact that anthrax can be treated with antibiotics, including some old-line, less-expensive antibiotics.”

This, Young told Fauci, seems to have “clouded” DoD’s vision, “because the use for which DoD immunized military personnel was never approved, namely for immunization against inhaled anthrax exposure. Whether or not one agrees, there is no scientific information in the public domain which supports licensing and approval in accord with the FD&C act and the relative sections of the Public Health Service Act that the vaccine is EFFICACIOUS in providing protection against aerosolized, or inhalation anthrax exposure. The 1985 Federal Register proposal (has never been issued as a final order) issued in accord with the findings of the expert vaccine review panel clearly stated that there was insufficient data to make an efficacy determination on its use in conjunction with aerosolized/inhaled anthrax exposure.

“Dr. Fauci, as an ex-military person (Colonel/USAFR (MSC) (Retired), but more specifically as an FDA regulatory official with years of experience in the drug approval process, including the investigational drug process, I can state that we have come a long way since Nuremberg and the Helsinki agreement in dealing with experimentation involving human subjects — we should not take a giant step backwards. CDC employees and/or U. S. Postal Service personnel should not be treated as human guinea pigs in this post-Nuremberg era. There has been no life-or-death emergency declaration.”

Young closed by recalling that CBER’s predecessor organization, the National Institutes of Health Division of Biologics Standards, was forcefully moved into FDA following congressional hearings on the release of a batch of live polio vaccine. That release action was deemed an abuse of discretion and opened the government to millions of dollars in tort liability claims. I was transferred into the Bureau of Biologics on the wake of that situation in 1975.”

1. Dr. Zoon was unaware that the anthrax vaccine's license review by FDA had never been finalized.

DR. YOUNG: My name is Sammie Young. I'm a retired Air Force Reserve Medical Service Corps officer, and I spent 29 years and two months as investigator and regulatory official with the Food and Drug Administration. She was Kathy when I knew her, when she came on board. [Laughter.]

DR. YOUNG: So my question is in two parts to Dr. Zoon. The first is I'd like for you to clarify the 1985 efficacy review report on anthrax vaccine which stated that there was not enough data to make a decision on the aerosolized contact. The order in accordance with the 1962 amendments to the Food, Drug and Cosmetic Act on efficacy required that a proposal be published and that the order be finalized in order to establish the safety and efficacy provisions for a drug or a biological. That order was never finalized. So we have a vaccine out there that is spoken of as approved, but yet the final order that would make that approval effective has never been published. That's my first comment. The second one, Section 501(a)(2)(b) of the Food, Drug and Cosmetic Act states amongst others that a drug or biologic that has not been manufactured in accordance with current Good Manufacturing Practices is adulterated. We don't administer adulterated drugs to human beings in the United States, and that hasn't been done as far as I know since, you know, the earlier days of the '40s. So my question is how have you come to the point that you can bypass a federal law and how you can you assure that the people from CDC who are going to get this vaccine that it's not adulterated or misbranded and that it will be safe for them? I have a little bit, a little more--well,go ahead.

DR. ZOON: Can I answer that, too? I'll go look into why. I'm not aware of why the order has not been published, but I will look into it."

2. Dr. Zoon was unaware that the licensure of the anthrax vaccine was based on the safety and efficacy data of a different vaccine.

"DR. YOUNG: The material--may I get a clarification? The material that is being used in the IND is not the material that was manufactured by the current manufacturer?

DR. ZOON: All the materials that are being considered or made available to HHS are made at BioPort. Some of it was made under the conditions of its former--well, under the conditions of its license, but it's not the one with the supplemental changes to the facility and the production procedures. But this is the same vaccine that was used in the Brachman studies and used in many other states once it was approved."

DR. YOUNG: And looking at the material that has been manufactured by the current license holder, that material was produced during a period when this company was not in compliance with current Good Manufacturing Practices, which by federal law and case law will support that, that that product in quarantine is adulterated. And as one who spent a lifetime in the Food and Drug Administration in a career, we did not permit the reconditioning of product that had not been manufactured in accordance with current Good Manufacturing Practices because you can't go back and do something you didn't do in the first place. So how are we going to deal with the material that is in storage? Now one last comment, it's a recognized scientific premise or whatever that end product testing alone is not sufficient for the release of a drug product.

DR. ZOON: Just two comments on that. The material was actually manufactured in 1992. And at that time, the BioPort was not under an intent to revoke or any of the conditions that we currently have. However, in saying that, I will agree with you that we have looked at this. These lots would never met the criteria for release for licensure. And the only reason that these would be considered, as I said, was an emergency situation with full informed consent on the nature of the product and what the deviations were, and quite frankly making sure that was transparent so the individual looking at this could be fully informed.

DR. YOUNG: Well, then a last comment on that then. I have a lot of experience in the investigational drug area, too. Will the informed consent statement say to the people from CDC that your product is legally adulterated?

DR. ZOON: I think it would lay out the manufacturing deviations. It would also lay out where it didn't meet spec.

------------ FACT: “MDPH was granted a license for a similar vaccine that differed from the original vaccine in three ways. First, the manufacturing process changed when MDPH took over. Second, the strain of anthrax that Merck used to grow the original vaccine was changed, and another strain was used to grow the MDPH vaccine. Finally, to increase the yield of the protective antigen (which is believed to be an important part of the vaccine's protective effects), the ingredients used to make vaccine were changed from the original vaccine.” (Ref: GAO Report -- Medical Readiness: Safety and Efficacy of the Anthrax Vaccine (04/29/1999), T-NSIAD-99-148, 29 Apr 1999)

FACT: "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial. Brachman employed a similar vaccine prepared by Merck Sharp & Dohme for Fort Detrick in a placebo-controlled field trial in mills processing imported goat hair. … No meaningful assessment of its value against inhalation anthrax is possible due to its low incidence." (Ref: Federal Register -- 13 December 1985 FDA Product Review and Proposed Rule for Anthrax Vaccine Absorbed, CFR 620)

FACT: The manufacturer also changed the vaccine manufacturing process without FDA approval. The changes of filters, in particular, may have created an up to 100 fold chemical increase in the protective antigen levels of the vaccine. (Ref: GAO testimony, 23 OCT 01, www.gao.gov)

ANTHRAX VACCINE NETWORK ISSUES FORMAL PROTEST AGAINST REQUEST TO WAIVE
FDA RULES IN VACCINE MANUFACTURING;
AND AGAINST USING ANTHRAX VACCINE AS A PUBLIC EXPERIMENT

MISSOULA, MT. AND ELLENDALE, DE: The Anthrax Vaccine Network, Inc. (AVN) today issued a formal protest against the "height of immorality, stupidity, and lack of concern for the public health" as represented by the request of drug companies and the Bush Administration to waive FDA rules in vaccine manufacturing, and to use stockpiled, expired, and quarantined doses of the highly reactive, dangerous anthrax vaccine on the American public, according to AVN President Kathy Hubbell. 11, 2001, about the bioterrorism bill now before Congress, Hubbell noted that, according to the story,

"Drug companies and the Bush administration have told Congress that rules of the Food and Drug Administration may interfere with the production of drugs and vaccines needed in a public health emergency. So, they say, the secretary of health and human services should be able to waive those rules to ensure that a sufficient supply of drugs will be available."

"When asked for examples, administration officials said they might want to suspend rules for the testing and labeling of drugs, vaccines, blood and blood products. Also, they said, the government may want to waive quality-control standards, "good manufacturing practices" and rules that require drug makers to notify the government of any serious illness or injury caused by the use of their products."

In the case of the current anthrax vaccine, Hubbell further noted, good manufacturing practices haven't been followed in the first place, and BioPort, the vaccine's manufacturer, certainly has not notified the government about the serious illness, injury and death caused by use of its products. This, she says, is part of the underlying problem in the government's stated wish to vaccinate a portion of the population with the anthrax vaccine on an experimental basis, with informed consent. Not only is the government proposing to use vaccine manufactured by the same company cited numerous times for quality control, lack of sterility in its products, the use of contaminated products, and withholding from the FDA the information that the company changed its filtering and fermenting equipment, resulting in a 100-fold deviation in potency of the vaccine; but that same government has already conducted a massive anthrax vaccine experiment, and has all the information it needs at its disposal. That experiment is the one conducted upon the troops in the armed services since at least 1989, with the current anthrax vaccine which has been on file with the FDA throughout this period as an Investigational New Drug, requiring informed consent by law. But no member of the military has ever been granted their legal right of informed consent; troops who have refused have instead been fined, put in the brig, court-martialed, and usually dismissed from the service under less than honorable conditions.

In addition, notes Hubbell, the Dept. of Defense, BioPort, the FDA, and the Centers for Disease Control have steadfastly refused to establish a national register of those who have taken the vaccine in order to track their reactions. One possible problem with this is that the national register, when made public, will show reactions ranging from severe joint and bone pain, to chronic fatigue, grand mal seizures, blackouts, brain lesions, tumors and cysts, the lack of the body's ability to produce testosterone in some men, severe menstrual and reproductive problems in some women, internal organ problems, autoimmune illnesses - and death.

"They have already decimated and demoralized thousands of our troops with this grand medical experiment," Hubbell said. "Troops who are medically discharged because they are so ill from the vaccine they can no longer work may or may not receive adequate medical care and VA benefits. Some will never be able to work again. Yet this is the vaccine they are unleashing on the American public. The stockpiled vaccine is adulterated and misbranded, a well-established fact, which was reiterated by retired FDA regulator and inspector Sam Young in his testimony before the Institute of Medicine last week. There are reasons it's been quarantined. We caution all Congressional staffers and others who are targeted to take this vaccine. If they want to volunteer for this grand medical experiment, that is their choice. But let's be honest about the devastating results in the military, and let's track results now. Let's see who is incapacitated for life, and who dies. Let's have them fight the physicians for an accurate diagnosis and for medical benefits. Let's tell them they are not allowed to sue because they signed an informed consent. Then let's casually drop our concern with FDA rules and good manufacturing practices."

For more information about the anthrax vaccine and the Anthrax Vaccine Network, see http://www.majorbates.com and http://www.anthraxvaccine.net, or call 1-888-411-3200.

Before I address the vaccine, I saw on the FoxNews ticker yesterday a mention that the Hart Sentate Office Building decontamination had FAILED a SECOND TIME. What's going on there? I recall they weren't *sure* the gas would eliminate the anthrax but does this mean they've used it twice, with a third attempt to come, and failed to destroy the anthrax spores?

Onward to the vaccine: Fox News' coverage indicated the vaccine would be COMPLETELY voluntary with full and complete understanding it may do no good, it may have serious side-effects and is entirely experimental. I wonder if Sen. Tommy Daschle has lined up for it yet?

Further, I wondered if this is or is not the same as the Gulf War era vaccine which allegedly causes the so-called "Gulf War Syndrome" and, if so, would be a useful "test case" to prove or disprove all this assertion over the years that GWS was caused by the vaccine (whine, whine... service was not compulsory).

This is a fascinating event in our history of public health.

This is my first time on Free Republic. Alas, I may have come in on the wrong thread as this one does not seem completely emblematic of intellectual conservatism at its best.

Anyway, isn't it slightly problematic to accept the benefits of modern medicine while insulting those who have participated in the studies which made it possible, by calling them a name (guinea pig)?

I work in a U.S. government office which gets loads of mail and is, I think, at moderate risk for receipt of a terrorist letter. If it were offered, I would gladly accept the bovine vaccine (never tried on humans except for rare errors, lasts just a year, becomes effective a lot quicker than human vaccine) on an experimental basis, knowing, without reading any silly release, that the personal benefit is iffy. Beyond knowing that I hadn't passively accepted my fate, I would have the additional psychic benefit of feeling myself an active participant in the war against terror. A little more reluctantly, I'd also accept the human vaccine. There is no risk-free medicine.

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