Word: informers
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Dates: during 1980-1989
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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...
...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...
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...
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...
...clandestine study became public in late June after a San Francisco volunteer suffocated on his vomit after coming out of a coma ten days following his first dose of Compound Q. The FDA launched an investigation into the underground trials, which Project Inform suspended. Two other volunteers have since died, one in San Francisco and one in New York. Levin says the death of one of the San Francisco men was indirectly related to Compound Q, while the cause of the New York man's death has yet to be determined...