[Letter to Robert C. Byrd from Harold Varmus and David Kessler]

01-21-94 04:7PM FROM OASPA NEWS DIV TO 916199424979001/002
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/DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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National Institutes of Health
Bothosda, Maryland 20 892
JAN -4 1994
The Honorable Robert C. Byrd
Chairman, Committee on Appropriations
United State Senate
Washington, DC 20510
Dear Mr. Chairman:
This letter is intended to serve as a certification by the undersigned that
the large-scale Phase III clinical investigation of the gpl60 vaccine should
not proceed. Our reasons for that determination follow.
The National Institutes of Health (NIH) convened a Panel in November of last
year to consider whether or not the "large-scale Phase Ill clinical
investigation (of gpl60] should proceed," as directed by the Department of
Defense Appropriations (DOD) Act, 1993. There were important considerations
that were included in those deliberations. First, there was an assumption
that the appropriated funds were inevitably going to be spent on a large-scale
efficacy trial of the gpl60 vaccine candidate. Second, the Panel assumed that
if such a trial was to be implemented, it was important to express, in their
best scientific judgement, how such a trial should be conducted. In this
context, the recommendations of the Panel, which were widely reported, were as
follows: 1) based on traditional scientific criteria, currently available
scientific information on gpl60 by itself cannot be considered adequate for
deciding to go forward with a large-scale clinical efficacy trial; and 2)
assuming that the appropriated funds were going to be expended on a clinical
trial including gpl60, the funds should be used for a large-scale clinical
efficacy trial to study several products. Because ongoing discussions during
the past year may have caused some confusion concerning our opinion in this
matter, the following clarification may be useful.
If one begins with the assumption that the question of the conduct of a largescale efficacy trial of a gpl60 candidate is indeed an open question, then our
intent must be restated. Based on the current state-of-tho-art in therapeutic
vaccine research, the NIH and Food and Drug Administration (FDA) cannot
recommend, on a scientific basis, that a large-scale efficacy trial of a
single therapeutic vaccine be conducted with public funds at this time. We
feel that the funds in question could more appropriately be used to answer
basic questions about the immune response and host defense mechanisms related
Lo vaccines prior to initiating large-scale human trials of a therapeutic
vaccine. This research could include the conduct of smaller Phase I and Phase
II trials of multipln vaccine candidates. The DOD could expand these studies,
if scientifically indicated, and initiate additional studies on promising
products. A decision to carry out a large-scale efficacy trial at a later
dat should be based on the knowledge accrued from the basic research

mentioned above as well as from the results of the ongoing clinical trials.
As you know, the DOD has a long history of conducting vaccine trials that have
led to the licensure of a number of vaccines for infectious diseases of
interest to their mission. In addition, they have established infrastructure
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