[Letter to William H. Natcher from Edward D. Martin]

JAN 21 '94 15:59 FROM OASD-PA-DDI-/ PAGE.001
THE ASSISTANT SECRETARY OF DEFENS
WASH iNGTO, 0. C. ZO 31-IZOo
ahe Honorable william H. Natcher
hairman, Committee on Appropriations
ouse of Representatives
ashington, DC 20515
ear Mr. Chairman:
Pursuant to the ninth proviso of the first paragraph of Title
V of the Defense Appropriations Act, 1993, as amended by section
005A of the Defense Appropriations Act, 1994, on behalf of the
eoretary of Defense, I hereby certify that, a large-scale Phase
II olinical investigation of the gpl60 vaccine should not
roceed. Similar certifications are being made by the Director
f the National Institutes of Health (NIH) and the Commissioner
f- the Food and Drug Administration (FDA).
The reason for this dotorminaton is that based on available
ata, it is premature at this time to initiate a large Phase III
herapeutic efficacy trial of gpl60 or any other vaccine therapy.
roduct. The U.S. Army Medical Research and Development Command
ontinues to believe the MicroGeneSys gpl60 has potential as a
herapeutic vaccine against the Human Immunodeficiency Virus
(H~V), and accordingly, plans to complete its current Phase II
rial of gpl60. Decisions on further clinical trials of this
- roduct will be based on the Phase II results.
The Department of Defense (DoD) continues to believe that
his novel approach to therapeutics, aimod at boosting the
ationt's own immune dofenses against the HIV, merits intense
xploration. Accordingly, the fiscal year 1993 special
ppropriation, available under the statute for other AIDS
esearch needs of DoD, will be used to fund a vaccine therapy
development program. The purpose of the program will be to
ccelerate development of new HIfIV vaccine therapy strategies and
roducto. Reseoarch proposals on this topic will be solicited in
he public domain from universities, industry, and others.
Submissions will be judged by poor review, and ~oloctionu will be
based on scientific excellence and potential for clinical
impact. DoD, 1DA, NIH, and non-government scientists will be
[nvited to participate in the peer review process.
A similar letter has been sent to the Chairman of the Senate
Committee on Appropriations.
Sinceroly,

Edward D. Martin, M.D.
Acting Assistant Secretary of Defense

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