FDA Webview -- FDA SILENT ON
ÎILLEGALâ ANTHRAX VACCINE IN U.S. STUDY: EX-FDAER --12/18/2001
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
Youngâs charges raise ãseveral issues that can not be addressed in a short
email. Iâll try to get back to you.ä 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 ãand in usual dancing
around she really didnât answer ÷ the issue of 501(a)(2)(B) fell on deaf ears.ä
[Sec. 501(a)(2)(B) of the federal Food, Drug & Cosmetic Act says that a
drug will be deemed to be adulterated ãif 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.ä]
The Washington Post reported from the meeting that as many ãas 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.
ãThe vaccination program,ä the Post continued, ãwould 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
ãexperimentalä basis because the vaccine has not received full government
approval.ä
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 Zoonâs response and to assert: ãI can assure you that
reputable scientists do not administer Îadulterateâ" 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.ä
Young told Fauci in his letter that the meeting at the National Academy of
Sciences seemed to confirm that there is no anthrax emergency ãsufficient to
warrant bypassing the human protection provisions of the Federal Food, Drug and
Cosmetic Act.ä He said the Department of Defenseâs (DoD) controversial use of
the BioPort vaccine on its own personnel had ãfailed to address the fact that
anthrax can be treated with antibiotics, including some old-line,
less-expensive antibiotics.ä
This, Young told Fauci, seems to have ãcloudedä DoDâs vision, ãbecause 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.
ãDr. 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.ä
Young closed by recalling that CBERâs 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.ä
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Two Excerpts from 15 DEC 2001 CDC Meeting:
1. Dr. Zoon was unaware that the anthrax vaccine's license review by FDA
had never been finalized.
Excerpt from transcript:
"DR. FAUCI: Question.
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.
Excerpt from transcript:
"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.
DR. YOUNG: Thank you.