Medical finds queue for official approval

Press, 22 September 1987, Page 4

Medical finds queue for official approval

By IRWIN ARIEFF NZPA-Reuter Washington A just-approved cholesterol treatment that may help millions fight heart disease is one of many potential medical breakthroughs wending their way through the United States Government regulatory maze, say drug analysts. Government regulators have approved a new type of cholesterol fighter, called lovastatin and made by Merck, that was found during clinical tests on humans to be able to lower blood cholesterol 18 per cent to 34 per cent.

Experts said the drug may benefit as many as 10 million Americans with excessive cholesterol levels that have not responded to dietary restrictions or exercise.

Industry analysts and Government' officials say the federal Food and Drug Administration (F.D.A.) is clogged with applications for other promising new therapies, some of which represent radical improvements over present treatments for some serious diseases. Among the experimental new medicines moving through the bureaucracy

are chemicals that may ultimately prove able to dissolve the blood clots that cause heart attacks, slow the progression of A.I.D.S. and combat cancers. Others may help grow hair on bald pates, help people shed excess weight or alleviate a drinking problem. Drugs never move through the bureaucracy as quickly as disease victims would like, and recent budget and staff cuts have tended to slow their progress even further. Then there is the agency’s usual caution in weighing the safety and efficacy of powerful compounds whose benefits may mask harmful side effects. In the case of A.1.D.5., in particular, the agency has come under fire for moving too slowly on promising treatments, though it has given A.I.D.S. (acquired immune deficiency syndrome) its highest priority. “The F.D.A. is applying rules to A.I.D.S. that were written in the thalidomide era,” said Larry Kramer, co-founder of the Gay Men’s Health Crisis Centre in New York, to a presidential. commission He referrea w .blocked by the F.D.A. for sale in the United States.

“Many or the people with A.I.D.S. only have two years to live,” said Mr Kramer, urging faster federal action. To date, only one drug — a compound called A.Z.T. made by Burroughs Wellcome — has been approved by the F.D.A. for A.I.D.S. in the United States market. The drug does not cure A.I.D.S. but slows its progression and improves the lives of victims. Numerous other promising anti-A.I.D.S. compounds are at early stages of testing on animals and humans. The F.D.A. in midAugust approved the first human tests in the United States of a vaccine against the A.I.D.S. virus developed by the firm MicroGenySys. Agency officials said other potential vaccines are not far behind though scientists predict that developing a successful vaccine will be a protracted process. Another drug mired in controversy at the F.D.A. is T.P.A., a bio-engineered blood-clot dissolving agent made by Genentech. The compound has been found in tests on humans to prevent and even stop heart attacks in .progress -by • clearing 4n'.ie^rartee,-setback, commit■"tee voted in May against recommending final approval of the drug, saying

more data was needed. The vote caused an uproar in the medical community and prompted a special F.D.A. review to determine if TPA should . now be approved without further delay. Upjohn’s minoxidil baldness treatment gained’ worldwide attention when researchers found that the compound, a blood pressure medication, could sprout hair on some bald heads. Though its approval was endorsed months ago by an F.D.A. expert committee, the agency is not likely to take final action on minoxidil for several more months, officials said. In the meantime, a lively black market has developed. A potential breakthrough in the treatment of obesity and alcoholism may come in final ’ approval of fluoxetine,, a* « new anti-depressant under' i development by Eli Lilly. An unusual side effect of the drug is that it appears to suppress desires to over-eat and overdrink by manipulating the | brain’s own chemistry. Though it will probably be approved by the F.D.A. j later this autumn onJj£sß use in treating depression, ' .physicians. ywill ?• ba ■ , it for '"iOTWPuses. ~ — u