Debating immutable science

WASHINGTON - The unique medical and social nature of AIDS played an important role in last week's review of Isis Pharmaceuticals Inc.'s Vitravene by the ophthalmic drugs subcommittee of the Dermatologic & Ophthalmic Drugs Advisory Committee. The panel voted 5-2 to recommend approval of the antisense compound for cytomegalovirus (CMV) retinitis in AIDS patients (see BioCentury Extra, July 23).

The discussion of Vitravene illustrated the impact of AIDS in situations where trial data don't meet the usual requirements for FDA approval, but where panel members believe that a drug should be available to patients...