[Letter to Jamie S. Gorelick from Harriet S. Rabb]

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I&DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary
4"'" The General Counsel
Washington, D.C 20201
August 20, 1993
DY...MEBEZNCER c'
Honorable Jamie S. Gorelick -
General counsel
U.S. Department of Defense FU
Office of the Secretary of Defense
Washington, D.C. 20301
Dear Jamie;
I have seen today's public announcement that the Department of
Defense (DoD) is preparing to start a large scale single vaccine
trial of MicroGeneSys gp 160 AIDS vaccine. It seems appropriate,
nonetheless, that I write to make clear the continuing readiness
of the Department of Health and Human Services (HHS) to direct a
multi-vaccine, multi-year clinical trial of potential AIDS
vaccines (including MicroGeneSys gp 160). Let me review the
events that underpin that proposal.
The October, 1992, appropriation to the Department of Defense
contemplated a test of qp 160 to be carried out by DoD unless,
within six months of the appropriation, DoD, the National
Institutes of Health (NIH) and the Food and Drug Administration
(FDA) certified in writing that the clinical investigation should
not proceed. [Attachment 1]. You will recall that the NIH
[Attachment 2] and the FDA [Attachment 31 both so certified. I
call your attention to the fact that the NIH certification was
based on deliberations of a panel of experts comprised of NIH and
FDA scientists and officials, DoD representatives and others.
[Attachment 2 at page 1] The NTH submission specifically
recommended that "...the large-scale clinical trial of a
therapeutic vaccine for HIV should be designed to study several
products, including the MicroGenesys gp 160 candidate vaccine and
other vaccine candidates from among those now being
developed...". [Attachment 2 at page 2]
In Late March and early April, 1993, the DoD engaged in
discussions with HHS regarding a mutual agreement to conduct a

large-scale, multi-vaccine (including qp 160) test under the
direction of HHS. HHS was to receive, by formal agreement,
$20 million appropriated to DoD for the purpose of carrying out
the test. During those discussions, HHS made clear its intention
to continue its longstanding practice of requiring that
manufacturers donate the vaccine to be tested. it was further