AEGiS-GMHC: Top AIDS Researchers Receive Warning

Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.

Top AIDS Researchers Receive Warning

Gay Men's Health Crisis "Treatment Issues", Vol. 8, No. 5 - July 1994
Derek Link

Two top federally funded AIDS researchers, Douglas Richman, M.D., of the University of California San Diego, and Lawrence Corey, M.D., of the University of Washington, received warning letters from the Food and Drug Administration (FDA) on May 11, 1994 for their role in clinical studies of FIAC and FIAU. These two closely related compounds were investigated for their activity against hepatitis B virus, cytomegalovirus and herpes viruses in HIV-positive and -negative people.

A year ago, five of ten trial participants receiving extended FIAU therapy for chronic hepatitis B died of liver failure. Two others required liver transplants to survive. Although Dr. Richman and Dr. Corey were not involved in this scientific fiasco, the FDA contends that their earlier research failed to follow federal regulations governing the conduct of human subjects research. Properly monitoring volunteers in earlier investigations could have provided timely warnings of FIAU's dangers, which surfaced in the fatal trial only after more than three months of treatment.

Stephen E. Straus, M.D., and Jay Hoofnagle, M.D., of the National Institutes of Health (NIH) were the principal investigators in the final disastrous study. They also received warning letters, as did the heads of Eli Lilly Company and Oclassen Pharmaceuticals, FIAU's corporate developers.

Warning letters are not the strongest action that the FDA can take. The agency could have banned the six from conducting clinical research.

A panel convened by the NIH held its own hearings early in June. In contrast with the FDA, the NIH panel concluded, "there is no villain other than the emergence and identification of a new and unique form of delayed drug toxicity."

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