Word: compounding
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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...
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...
...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...
Without revealing the purpose, Project Inform asked Genelabs, Inc., a California biotechnology firm that manufactures the drug in the U.S., to test samples of Compound Q that Corti brought back from China. They wanted to make sure it was identical to the Compound Q used in the FDA-approved study. An attorney drew up guidelines that would keep the trials within federal law. Each patient made a videotaped statement, in the presence of an attorney and a witness, that he was entering the trial of his own free will. "What we wanted was a trial that was faster than...