FDA Approves Controversial AIDS Drug

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WASHINGTON, D.C.: The Food and Drug Administration approved a new AIDS drug to be used in combination with other drugs, despite conflicting reports of how well the drug works and a dearth of information about how it reacts to the most common drug combinations used by patients today. The drug, called delavirdine, is one of a class of drugs that are not nearly as powerful as the AIDS ``protease inhibitors'' that have dramatically changed the landscape of HIV treatments and have brought scientists the closest to stopping the spread of the virus. While the manufacturers Pharmacia and Upjohn reiterated today that the drug should be used only in combination with other drugs, they have not yet studied it taken together with protease inhibitors, the standard of care for AIDS patients. When others did, the studies produced such conflicting data that the FDA's scientific advisers in November deadlocked over whether to approve the drug. One study showed delavirdine taken with the drug AZT modestly helped early-stage patients' immune systems and killed twice as much of their HIV virus as AZT alone. But a study of severely ill patients found that the benefit lasted only 12 weeks when they took delavirdine with ddI, an older medicine. Still, the drug made it through the FDA with relative ease because as an HIV drug it had been put on the FDA's "fast track," which the agency established in 1992 to speed delivery of new medicines, but which had the effect of lowering the standards of proving a drug's safety and efficacy.