Word: compounding
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Dates: during 1980-1989
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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...
...trial's volunteers were all men who had failed to respond to conventional AIDS therapy, including AZT, so far the only FDA-approved drug for treating the AIDS virus. To obtain accurate readings on Compound Q's effectiveness, volunteers were asked to stop using any other approved or unapproved drugs...
...secret trials began on May 24 in San Francisco. For three weeks, patients received infusions of Compound Q, some as high as 17 times the dosage given patients in the San Francisco General Hospital toxicity trials. For the first 48 hours, the carefully monitored volunteers suffered side effects of sore muscles, nausea, fever and fatigue. The side effects eventually went away, and many patients, including Bob Barnett, began to feel more energetic...
...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...
Some researchers raise serious doubts about the methodology of guerrilla drug tests. Project Inform is strongly criticized for bypassing an initial phase to establish Compound Q's safety before proceeding to larger, therapeutic dosages and for not having the trials reviewed by an external monitoring group. Says Jere Goyan, dean of the University of California at San Francisco School of Pharmacy and a former FDA commissioner: "If you get people taking these drugs willy-nilly around the country, you'll lose valuable information, and it will be at the expense of future patients...