Being Alive Newsletter; December 1992
Walt Senterfit

The most widely known are the gp160 vaccine, developed by the MicroGeneSys company and developed largely in cooperation with the US Army's Walter Reed Research Center, and the Salk Immunogen vaccine tested initially here at USC and then later in Philadelphia. Both have been found to be safe in people with more than 400 T-cells and have engendered a measurable increase in immune system response in a majority of those tested. What is not yet clear is whether this response translates into real clinical benefit in terms of reducing the incidence of symptoms and slowing the progression of disease. Many believe that it will yield such promising results; others doubt it.

Most agree that the time has come for much wider testing of these and other candidate agents (including products made by the Genentech and Chiron biotech companies). The ACTG is set to start two new protocols toward this end within the next three months. One study will be a blinded comparison of several of the vaccines and the other will be a trial of vaccine therapy in people with lower T-cells (200-350, to be specific, and then toward gradually lower limits if the first ones indicate it is safe to do so) than have been previously tested.

Much controversy has ensued in the highly irregular success of MicroGeneSys in lobbying Congress to appropriate $20,000,000 specifically for a large scale trial of their gp160 vaccine. This sum was added to the Defense department's research budget for the Army to carry out such a trial. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) were quite incensed at this instance of corporate political influence so grossly affecting the research agenda and furthermore doing so outside the NIH's control.

A group of activists (including myself), however, decided to try to turn this event to our advantage. Before a high level meeting convened in early November to advise the NIH on how in turn to advise the Army, we prepared and presented a proposal to use the money to conduct a large scale clinical trial of ALL the reasonable candidate vaccines, not just gp160. We stressed that the trial should be open to all HIV infected people, regardless of T-cell levels, who wish to volunteer, and should reflect the full demographic variety of the epidemic. Further, the trial should be large enough (which turns out to mean about 30,000 participants) to give useful answers to the pending questions in a reasonably short period of time (about two years or less). To facilitate such a large trial, the data collected on the majority of the participants should be minimal (to cut the cost and the inconvenience) but still sufficient to assess outcomes, while a representative minority would contribute more blood samples to study immunologic and virologic parameters in detail.

Since no one else came to the meeting with a clear proposal, ours became the focus of the meeting. Further meetings and negotiations with the Army will determine what actually happens.

Meanwhile, some colleagues of Dr. Robert Redfield, the chief investigator of gp160 at Walter Reed, have charged that some of Redfield's reports have exaggerated the positive effects of the vaccine beyond what is justified by the actual data he has collected. Consequently, the Army has announced an investigation into his research and his claims.

Thus far, all involved have stressed that no fraud or outright misrepresentation is being alleged, but rather that he has "overinterpreted his results." This warrants further close scrutiny by the AIDS affected community.

The strong economic interests of drug companies and the ego or career interests of scientists have often led to exaggerated claims and misplaced hopes. However, it is also important to realize that we who are living with the virus have to make do (very watchfully, of course) with the flawed system and personalities that exist, even as we are working to make it brighter, faster, more accessible and more ethical.

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