Looting the Medicine Chest: How MicroGeneSys Sought the Inside Track on an AIDS Drug

Article excerpt

How Micro GeneSys sought the inside track on an AIDS drug

In a variation on a Georges Clemenceau theme ("War is too serious a matter to be left to generals") the U.S. Senate pulled on white coat and rubber gloves last fall and moved into the battle against AIDS.

Acting in its closing days, with hardly a dissenting vote, the 102nd Congress adopted a Senate amendment adding $20 million to the Pentagon's appropriation for fiscal 1993, earmarking the sum specifically for large-scale tests of one particular vaccine among several being developed against the human immunodeficiency virus (HIV).

The sum involved was trivial - 1/125 of 1 per cent of the $260 billion military budget and 2 per cent of the $1 billion allotted to AIDS research by the National Institutes of Health. But the principle involved was important: Though members of Congress often finance pet projects by tacking last-minute riders onto appropriations bills, this was the first time legislators presumed to usurp medical judgments made by people who had solid scientific credentials.

There is more behind the AIDS amendment than just the usual wrongheadedness of such powerful figures as Democrat Sam Nunn of Georgia and Republican John Warner of Virginia, who introduced it on the Senate floor. They had help and encouragement - lots of it - from an influential ex-Senator turned lobbyist, Democrat Russell Long of Louisiana.

Nunn and Warner, respectively chairman and ranking minority member of the Senate Armed Services Committee, in collaboration with Long, former chairman of the Senate Finance Committee, brought insider politics to a new flowering, even in a milieu where the term "Congressional ethics" is viewed as an oxymoron.

The AIDS-amendment caper is best understood against the backdrop of a few facts about this troubling disease. From the time it was publicly identified in 1981 through September 30, 1992, acquired immune deficiency syndrome has been diagnosed in 242,146 persons in the United States, of whom 160,372 have died. In addition to the 81,774 still living, there are an estimated one million Americans who are "HIV-positive" - that is, infected with the virus and both susceptible and contagious, but lacking classic AIDS symptoms. From what is known of the virus and its effects, it is reasonable to assume that these infected individuals will progress to actual AIDS, for which there is no cure and no effective medical prevention.

Immunization, along the lines of the now-obsolete smallpox vaccine, would be an obvious answer, and indeed a quest has been under way almost since the causative virus was isolated in the early 1980s. Overly rosy predictions surfaced immediately, beginning with one by Margaret M. Heckler, then Secretary of Health and Human Services and later Ambassador to Ireland, who prophesied at a 1984 press conference that a vaccine would be available within two years. Three years later, Dr. C. Everett Koop, then Surgeon General of the United States, was asked publicly what had happened to Heckler's promised vaccine. "I guess she must have taken it to Ireland with her," he said.

Some palliative progress, but not a cure, has been achieved since then-notably the drug AZT, which got fast-track approval several years ago and is now the mainstay of AIDS therapy for those who have the money to pay for it. The ongoing search for a vaccine has branched, the first path toward a preventive one (which would immunize people not yet exposed to the virus) and the second toward a therapeutic one (which would suppress, reverse, or even eliminate symptoms in infected individuals).

The therapeutic route now seems the more promising and is the focus of lively competition among several gene-splicing companies bearing such science-fictionesque names as Genentech, Chiron, Biocene, and MicroGenesys (pronounced "micro-genesis"). All have come up with genetically engineered candidates - a total, in fact, of sixteen allegedly therapeutic AIDS vaccines, seven of which the National Institutes of Health is evaluating as part of the overall AIDS research program. …