AIDS TREATMENT NEWS Issue # 185, 10/15/93
Dave Gilden

The controversy started a year ago when lobbyists hired by MicroGeneSys Corp. convinced Congress to allocate $20 million dollars for the Walter Reed Army Institute of Research to further test the company's therapeutic vaccine. (Therapeutic vaccines are supposed to strengthen the anti-HIV immune defenses in people already infected by the virus -- see the article in this issue on the First International Conference on Engineered Vaccines for Cancer and AIDS.)

The original appropriation was reviewed by a panel created by the National Institutes of Health. Nine months ago, this blue-ribbon panel urged that a multiproduct comparison trial be carried out, rather than testing a single vaccine alone (see AIDS TREATMENT NEWS #164, December 4, 1992). But on September 27, 1993, many of the non-NIH members of the panel signed a statement arguing that "the scientific evidence to date does not yet justify Federal support for a large phase III [efficacy] study of either one or several candidate HIV therapeutic vaccines." The statement's signers want the $20 million disbursed as a grant program, underwriting a broad range of AIDS research. Proposals would be judged by an expert review panel set up by the Department of Defense. White House AIDS policy coordinator Kristine Gebbie, M.N., took a similar position on September 28, in a letter to Rep. Henry Waxman (D-CA), the chair of the House Subcommittee on Health and the Environment.

Gregg Gonsalves, of the Treatment Action Group in New York, reports that spending the $20 million on peer-reviewed, investigator-initiated AIDS research is also the favored course of the vast majority of the respondents to a TAG survey among activists and scientists. (That survey was published in ATN #183.) He notes that this course does not preclude a large trial of one or more therapeutic vaccines. It just makes the Army researchers get in line like everyone else to justify their proposal.

Back at Walter Reed, Deborah Birx, M.D., has been working since the spring to get a large comparative trial off the ground. (The idea of testing the MicroGeneSys vaccine alone seems to have fallen by the wayside. Her concept is now similar to that originally floated by the NIH panel.) She has managed to convince MicroGeneSys to agree to donate its vaccine on a year to year basis for such a trial, something the company was previously unwilling to do. Dr. Birx is now trying to get other therapeutic vaccine developers to similarly aid the study -- at a cost to the companies of $2 million per year.

Birx envisions conducting a three-year, placebo-controlled trial with several thousand people per vaccine arm. People with a wide range of helper T-cell counts would be observed, and everyone could take whatever other drugs they wanted, except for experimental antiviral medications.

Dr. Birx contends there are hints that therapeutic vaccines are useful for treating HIV. But, she told AIDS TREATMENT NEWS, "Either you buy into this trial as something that doesn't follow the normal scientific steps or we'll be seven years from the answer [of how effective therapeutic vaccines are] according to usual procedure."

Dr. Birx does have a certain amount of support among community-based researchers, who would be included in the trial, and among people with HIV searching for new treatment options. Interestingly, she is close to her opponents' position in that she supports a kind of massive roundtable of scientific and community representatives to reach a consensus about her project.

A consensus-building process of one sort or another may get a chance to work if an amendment to the 1994 Defense budget is passed. That amendment, proposed by Rep. Waxman and now approved by the House of Representatives, would give the government another six months to review the need for a large vaccine trial.

So the saga of the Army's and MicroGeneSys's $20 million continues to unroll. "We're seeing the best and the worst of the democratic process," complained Joseph Camarado of Wyeth- Ayerst Laboratories, MicroGeneSys's corporate backer.

But while arguments re-flared over this $20 million, Congress on October 5 passed a $227 million increase in AIDS research funding without any controversy. That money will be distributed through the National Institutes of Health's regular grant award process involving independent scientific review committees.

The NIH process has plenty of critics, but it is still more orderly than having Congress earmark funds for specific projects on a political basis. Commented Terry Beswick, who, at the time of interview, was set to become a temporary advisor to Kristine Gebbie on research policy, "This is a lesson in the bad management in science."

Finally, if the groups working on the therapeutic vaccine trial issue cannot come to an agreement, there is an almost completely unnoticed measure before Congress to take back the money. H.R. 1392 (S. 1090 in the Senate) is a general bill to erase a wide range of mistaken appropriations in last year's budget. Included in the 3,000 lines of text is a short clause canceling funding for the large-scale vaccine trial on the grounds that the proposed trial has not been subject to competitive bidding.

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