French abortion drug RU 486 U S research battles heat up

Abstract:  PIP: With increasing evidence that the controversial French-made abortifacient RU-486 may serve as a treatment to some diseases, Congress and researchers have stopped up the pressure on the Food and Drug Administration to make the drug more available for clinical trials. The FDA has banned the import of RU-486 for personal use, and has placed strict restrictions on importations for clinical studies, having approved only 10 Investigational New Drug applications as of December 1990. Legislators and researchers say that RU-486's maker, Roussel-UCLAF, has also kept tight control of the drug because its parent company, Hoechst, fears reprisals from anti-abortion groups. Nonetheless, preliminary clinical results have shown the drug to have positive results in the treatment of unresectable meningioma, breast cancer. Cushing's syndrome, and endometriosis. A clinical trial conducted at the University of Southern California showed that a daily dose of RU-486 led to minor tumor regressions in 6 of 24 patients with the normally untreatable unresectable meningioma. These results have not gone unnoticed by Congress; the House Small Business Subcommittee on Regulation held a meeting to discuss the issue. The Subcommittee heard from researchers who say that their studies have been affected by the FDA's actions. An FDA representative explained the tight control over the drug by saying the possibility exists that a black market for the drug might arise. Nonetheless, he said that the FDA is not trying to prevent legitimate research. But Subcommittee Chairman Ron Wyden, who favors abortion rights, criticized the FDA's ban as politically motivated.