Bob Barnett sits on an examination table in San Francisco while an intravenous needle drips an experimental AIDS drug into his veins. The drug, called Compound Q, is a purified protein extracted from a cucumber-like Chinese plant and one of the latest promising glimmers in the search for a cure for AIDS.
Across town, researchers at San Francisco General Hospital Medical Center are conducting cautious, federally approved Phase 1 toxicity trials with minute dosages of GLQ223, as Compound Q is officially known. But for Barnett, a 37-year-old former radio sales manager, as for thousands of others afflicted with AIDS, precious time is running out. Barnett wants to know if Compound Q works in larger therapeutic doses. He wants to know now. "My options are death and doing this," he says.
Barnett is one of 51 AIDS patients who, along with six doctors, took part in underground trials of Compound Q this past spring and summer. The clandestine study was organized by Project Inform, a San Francisco-based group of activists who believe the Food and Drug Administration's system for testing potentially life-saving new drugs is unconscionably slow. On Sept. 19, Project Inform director Martin Delaney revealed the preliminary results of the underground trials to an intent crowd of some 500 predominantly gay men in San Francisco. Although many of the trial's volunteers, including Barnett, showed a marked decrease in activity of the human immunodeficiency virus (HIV) that causes AIDS, Delaney said, Compound Q could not be considered a cure. But the desperation of the epidemic guarantees that underground drug trials will continue; AIDS activists say at least two dozen such experiments are under way across the U.S.
Hope flashed through the nation's AIDS community last April, when researchers from the University of California at San Francisco announced that, in test tubes at least, Compound Q could kill HIV-infected cells while leaving healthy cells unaffected. The substance quickly found its way into the U.S. and to desperate AIDS patients, who administered the drug on their own. "Word was out," says Dr. Alan Levin, medical director of the Project Inform trials in San Francisco. "People started getting it and injecting themselves in their kitchens."
To Delaney, such haphazard self-medication posed its own threats. "We said, 'Instead of just passing it out to see what happens, let's channel it into controlled clinical use,' " Delaney recalls. He contacted James Corti, a Los Angeles-based activist and importer of AIDS drugs who shipped 400 doses of Compound Q out of China.
Delaney then asked a group of doctors to design a protocol, or test model, based on an FDA trial for a similar drug called Ricin Toxin. Delaney says several FDA and National Institutes of Health officials in Washington were told of Project Inform's proposed trial, which was planned for patients in San Francisco, Los Angeles and New York City. "At no time did anyone tell us to stop," he says. An FDA spokesman in Washington claims officials did not hear about the clandestine trials until well after they began.