Ê 12/17/01
Dr. Anthony Fauci
DHHS/National Institutes of Health
Bethesda, MD
Dear Dr. Fauci:
As an attendee at the Saturday December 15, 200l CDC/NAS sponsored
symposium "Optimizing Post-exposure Prevention of Inhalational Anthrax:
Issues and Options," as a former Investigator (Drug specialist) and
Regulatory Official for 29 years with the U. S. Food and Drug Administration
(FDA) I respectfully, wish to express some concern over the lack of
concern over the "adulteration" issue which I brought up in the
Q&A portion of the block on Post -Exposure Immunoprophylaxis which you were
co-moderator with Dr. Snider.
I bring this up because although I do not share the
eminent scientific reputation you have achieved, I believe that as U. S.
Government employees, I, now retired, (we) live under a sworn obligation to
protect the U. S. Constitution (which provides for the protection of the public
health).
I refer primarily to my questions and comments directed
to Dr. Zoon, Director, Center for Biologics Evaluation and Research (CBER) on
drug safety and drug approval in the U. S. relating to the
"adulteration" status of currently available anthrax vaccine, and the
acknowledgement by Dr. Zoon, that, in a proposed investigational program directed
at immunizing (against anthrax) human beings, namely, that CDC personnel and/or
U. S. Postal Service personnel would be administered anthrax vaccine which she
stated, did not meet specifications and would not be licensed (safe and
effective) by CBER.
If you will review the transcript of the proceedings ( I do
not know if a video was produced) you will find that Dr. Zoon, whom I have
known since she was a new FDA employee and I, a senior regulatory official at
the former Bureau of Biologics/FDA, did not answer my questions relating
to whether or not the government would administer "adulterated"
vaccine to CDC personnel, nor did she explain how CBER would address the
"adulteration" issue if the proposed vaccination program proceeds.
In over 29 years of experience in FDA, I can assure you
that reputable scientists do not administer "adulterated" 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.
For more than 2 years, the current anthrax vaccine
license-holder has been unable to pass inspections by the U. S. Food and Drug
Administration. These periodic Inspections are mandated by federal
statute and conducted for the purpose of determining the state of compliance
with Current Good Manufacturing Practice (CGMP) as determining the ability of a
firm to manufacture human drugs and biologicals that are safe and effective.
The Federal Statute (FD&C Act) at sec. 501(a)(2)(B)
states in part:
Sec. 501(351) A drug or device shall be
deemed to be adulterated -----
(B) 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....
Current
events lead some of [us] to believe, and seemingly confirmed by a speaker
on the panel Saturday, Dr. I Walk, of the Washington D. C. Health Department,
in a later comment period, that there is no emergency sufficient to
warrant by-passing the human protection provisions of the Federal Food, Drug
and Cosmetic Act (FD&C Act).
Further,
we now know that DOD virtually based its bio-terrorism program on the potential
for personnel exposure to B. anthrax and as should have been included in any
legitimate planning or scientific endeavor, they failed to address, in their
consideration of the potential terrorist impact, the fact that anthrax can be
treated with antibiotics, including some old-line, less-expensive
antibiotics. It also appears, from Dr. Brachman's presentation,
that as far back as circa 1954, anthrax was not considered a public health
problem, primarily because of the seemingly limited population expected to be
exposed in a small occupational field (textile/wool-handling,) but was
always studied in conjunction with its potential for use in bio-terrorist
activities.
One might suspect that DOD's "hang-up"
clouded its 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.
This country has the scientific
knowledge and expertise "to do it right" and to not engage in a
practice that violates the public health protection provisions of federal laws,
especially in the absence of a declared national emergency.
For your information, as
a Bureau of Biologics Compliance Officer, I served on one of the local FDA/NIH
Institutional Review Committees for the Swine Flu vaccine. I was
comfortable enough with the scientific input as well as the manufacturing
practices (CGMP) employed in the production of the vaccine that I agreed
to, and did receive the experimental vaccine. Tests in accord with
the IND protocol revealed full immunity.
Since the Federal Government assumed full liability in the Swine Flu episode,
my office was responsible for the [maintenance] of all of the files and records
on the Swine Flu vaccine episode, and these were [distributed], openly,
to litigants and all interested parties. I am not unfamiliar with the
vaccine approval process, as well as the liability issues involved.
The Saturday December 15, 2001 presentation was a headlong
movement into addressing the vaccine immunization issue, without any apparent
consideration of a most important factor, is there a legal vaccine
available?
I respectfully request that this issue be considered in
your involvement in the deliberations on the Investigational anthrax vaccine
initiative in discussions with DHHS. I am aware through years of
experience that an administrative agency has wide DISCRETIONARY PREROGATIVES,
INCLUDING ENFORCEMENT PREROGATIVES.
However I am also aware that the Division
of Biologics Standards (DBS)/NIH, predecessor to the current FDA/CBER, was
forcefully moved into FDA following congressional hearings on the release of a
batch of live polio vaccine. That release action was deemed ABUSE OF
DISCRETION and opened the government to millions ($) in tort liability claims.
I was transferred into the Bureau of Biologics on the wave of that
situation in 1975.
Respectfully submitted,
Sammie R. Young
Silver Spring, MD 20905