[Letter to William H. Natcher from Bernadine Healy]

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04 06 93 14:05 '301 402 3522 MEDIA RELATIONS 002;DEPARTMENT OF HEALTH & HUMAN SERVICES Pub c Health Service
National Institutes of Health
Bethesda, Maryland 20892
MAR 31 1993
AP4
The Honorable William H. Natcher
Chairman
Committee on Appropriations
H 218 - The Cypitol
U.S. House of Representatives
Washington, D.C. 20515
Dear Mr. Natcher:
The 1993 Department of Defense Appropriations Act provided $21
million "for a large scale Phase III clinical investigation of
the gpo60 vaccine....." The appropriation language specified
that the funds be obligated "unless, within six months after the
date of the enactment of this Act, the Secretary of Defense, the
Director of the National Institutes of Health, and the
Commissioner of Food and Drugs submit to the Committees on
Appropriations of the Senate and the House of Representatives a
written certification containing a determination of such
officials that the large scale Phase III clinical investigation
should not proceed, the reasons for that determination, and an
assessment of the gp 160 vaccine....."
In response to that directive, the National Institutes of H".h
convened a panel of experts to assist in providing the scie:,fic
advice requested concerning the merit of proceeding with the
proposed large scale clinical investigation. The gpl60 Panel was
comprised of NIH and FDA scientists and officials, DoD
representatives, university scientists, representatives from the
pharmaceutical industry, members of health advocacy
organizations, and experts from nursing, medical ethics, and law.
(Attachment 1)
The full Panel met on November 5 and November 23,.1992 to address
the following essential questions: (Attachment 2)
* What is the current scientific assessment of the
MicroGeneSys gpl60 vaccine candidate as a therapeutic
agent?
* Based on gpl60's scientific merits, should a large-scale
efficacy trial be initiated in HIV-seropositive
individuals?

* What role should NIH play in reviewing proposals for such a
large-spale clinical trial?
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