Approval of zidovudine (AZT) for acquired immunodeficiency syndrome. A challenge to the medical and pharmaceutical communities

THE ANTI-INFECTIVE Advisory Committee to the Food and Drug Administration (FDA) recently recommended the approval of zidovudine (azidothymidine [AZT]) for use as a treatment of selected patients with acquired immunodeficiency syndrome (AIDS), but only for those with advanced illness characterized byPneumocystis cariniipneumonia and depressed immunity and for symptomatic cases of AIDS-related complex (ARC). It did not, however, recommend approval of zidovudine for treatment of pre-AIDS or nonadvanced AIDS cases with other opportunistic infections. Within two months of that recommendation, the FDA released the drug for use for the above indications. The committee, which I chaired, was made up of 11 medical experts in infectious diseases and other disciplines; it was asked to review data from one placebo-controlled clinical trial of patients with AIDS who had recovered from their first episode ofP cariniipneumonia before enrollment and patients with ARC who had multiple clinical symptoms, such as oral