Subject: Anthrax vaccine may in fact be experimental
Date: Sun, 04 Jul 1999 18:37:23 -0400
From: Meryl Nass <mnass@netquarters.net>
To: "Anthrax-no@onelist.com" <Anthrax-no@onelist.com>
The following memorandum, posted earlier today (7/4/99), is extremely
important. It appears to provide verification that contracts were
entered into to produce anthrax vaccine in at least one site that did
not have an FDA establishment license to do so. This seems to
substantiate the rumors regarding Project Badger's initiative to have
other corporations manufacture and ship anthrax vaccine to MDPH for
bottling and labelling, so it would appear that the vaccine originated
at MDPH.
Furthermore, vaccine produced under such conditions would not be FDA
licensed and would therefore be experimental. It could thus not legally
be given without informed consent. Since informed consent has not been
obtained for the current anthrax vaccinations, servicemembers may have
been vaccinated illegally, and are therefore eligible for legal
redress. In addition, administering an unlicensed vaccine would void
the "lawful order" argument.
Can the lawyers on this list comment?
Meryl Nass
S E C R E T A R Y O F T H E A R M Y
WASHINGTON
September 3, 1991.
MEMORANDUM OF DECISION
SUBJECT: Authority Under Public Law 85-804 to Include
and Indemnification Clause in Contract DAMD17-91-C1086 with
Program Resources, Inc.
Program Resources, Inc. (PRI), a wholly -ownded subsidiary of DynCorp,
has requested that the Army include
an indemnification clause under 50 U.S.C. (two S like symbols here)
1431-1435 (Public Law 85-804) for the production of anthrax vaccine
under Contract DAMD17-91-C-1086 with the U.S. Army
Medical, Research and Development Command (USAMRDC).
The contract is a cost-reimbursement effort which requires the
production of bulk anthrax vaccine. PRI will perform the contract at
the National Cancer Institute's Frederick Cancer Research and
Development Center in Frederick, Maryland, where PRI is the operating
contractor, over a one-year period. The contract contains an option to
extend the period of performance for up to two additional six-month
production increments. After bulk lots have been produced, the vaccine
will be shipped to the Michigan Department of Public Health (MDPH) in
Lansing, Michigan. There, under separate contract, MDPH will perform
the purity testing, bottling and labeling of the vaccine. This contract
will be performed in conjunction with Interagency Support Agreement No.
Y03-CO-10567 between the National Cancer Institute and USAMRDC.
The obligation assumed by PRI under this contract involves unusually
hazardous risks associated with potentially severe adverse reactions and
the potential lack of efficiacy of the anthrax vaccine. These concerns
stem from: a) the limited use of the vaccine to date, i.e., tests prior
to approval of a vaccine by the Food and Drug Administration are on too
small a scale to permit accurate assessments of types and severity of
adverse reactions (only widespread use can provide this assessment;)
and b) insufficient experience in mass immunization programs to truly
evaluate the efficacy of the vaccine. Moreover, there is no way to
predict whether the pathogen against which the vacine may be used will
be sufficiently similar to the pathogen used in tests to ensure vaccine
efficacy. I find that performance of this contract will subject PRI
to certain unusually hazardous risks defined in Attachment A.
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Page 2
I have considered the availability, cost and terms of private
insurance to cover these risks, as well as the viability of
self-insurance, and have concluded that adequate insurance to cover
these unusually hazardous risks is not available to the contractor at
a reasonable cost. While limited "claims-made" insurance is available
to the contractor, the uncertainty over when the vaccine will be used
and the vaccine's long storage life make the cost of maintaining this
insurance coverage unreasonable. Furthermore, there is an urgent need
to replenish vaccine stockpiles in the aftermath of Operation Desert
Storm. On the basis of this review, I find that use of an
indemnification clause in the contract will facilitate the national
defense.
In view of the foregoing and pursuant to the authority vested in me by
50 U.S.C. ßß 1431-1435 (Public Law 85-804) and Executive Order 10789, as
amended, I hereby authorize USAMRDC to include the indemnification
clause set forth at FAR Subpart 52.250-1, together with Alternate I, in
Contract DAM17-91-C-1086, provided the contract defines hazardous risks
precisely as described in Attachment A.
Should it prove necessary in implementing this Memorandum of Decision to
incorporate language into the contract to clarify terms found in the
indemnification clause, the contracting officer shall not include any
such clarifying language without the prior review and approval of the
Office of the Assistant Secretary of the Army (Research, Development and
Acquisition).
It is not possible to determine the actual or estimated cost to the
Government as the result of the use of this indemnification clause,
inasmuch as the liability of the Government, if any, will depend upon
the occurrence of an incident in the definition of unusually hazardous
risks.
The contractual documents executed pursuant to this authorization shall
comply with the requirements of FAR Subparts 28.3 and 50.4 as
implemented by the Department of Defense and the Department of the
Army. The contracting officer shall not require, and the Army shall not
reimburse the contractor for the cost of, insurance coverage applicable
to the unusually hazardous risks and in excess of the minimum required
by FAR Subpart 28.3
/signed/
M. P. W. Stone
ATTACHMENT A
DEFINITION OF UNUSUALLY HAZARDOUS RISKS
The risk of adverse reactions, or the failure to confer immunity against
anthrax, from the administration to any person of the vaccine
manufactured or delivered under this contract. For purposes of this
clause, the phrase "adverse reactions" includes anaphylaxis and other
foreseeable adverse reactions, as well as, any unforeseen adverse
reactions.
--
** Please note new email address **
mnass@anthraxvaccine.org
====================
Meryl Nass, M.D.
124 Wardtown Road
Freeport, Maine 04032
phone (207) 865-0875
fax (207) 865-6975