Word: fda
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...Ellen Cooper, a Federal Drug Administration (FDA) official, said that while "no one argues against the principle of individual autonomy," her organization must consider certain ethical and scientific realities before it can make experimental drugs widely available...
...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...
...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...
...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...
...Delaney, such reasoning is flawed because it suggests that some victims who might be helped by experimental drugs may die while the traditional methods of testing drugs work their slow and cumbersome way. Pressure from AIDS activists has resulted in the FDA's allowing wider use of such experimental AIDS drugs as r-erythropoietin, which is used to treat AIDS- related anemia, before studies have been completed. Compound Q faces much more rigorous testing despite the hint of promise. "It's not a one-shot cure," Delaney warned the packed community meeting. But Bob Barnett, a true believer...