Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, May 21, 1994                   TAG: 9405230151
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A3   EDITION: METRO 
SOURCE: Associated Press
DATELINE: ROCKVILLE, MD.                                LENGTH: Medium

ADVISERS URGE OK OF AIDS DRUG

An advisory committee to the Food and Drug Administration said Friday that Stavudine, or d4T, probably provides some benefit over the three existing AIDS drugs. But the panel couldn't say just who would benefit, just how safe it was or whether the manufacturer was on the right track to answer the many questions.

``I'm not sure how good our advice was today,'' said Dr. Deborah Cotton, a Harvard professor who chaired the panel.

The FDA is considering whether to permit the sale of d4t under a special procedure that allows promising drugs for life-threatening diseases on the market before their makers prove definitively that they work.

The FDA has not said when it will decide on d4T. It is not bound by advisory board decisions, but generally follows them.

Bristol-Myers Squibb says d4T appears to help raise the immunity of people with HIV, the AIDS virus, while causing fewer side effects than other AIDS drugs.

Currently, there are three approved AIDS drugs, AZT, Zidovudine; ddI, or Didanosine; and ddC, or Zalcitabine. Each works by blocking the action of an enzyme called reverse transcripase that the virus uses to replicate.

All cause fairly severe side effects and the virus can mutate to resist them. Some patients experience resistance to AZT, the most widely used drug, as soon as six months after starting it.

d4T works in a similar manner.

But there are major unsettled questions about the new drug: Who will it benefit? Are there short-term benefits? Does it increase AIDS patients' survival? Are there fewer side effects, as the manufacturer claims?

The company asked FDA to approve d4T for AIDS patients who cannot take any of the other drugs because of serious side effects or drug resistance.

It has studied 10,000 people, giving them two different doses of d4T. After 11/2 years, 79 percent are still alive, but 21 percent have experienced some peripheral neuropathy, a painful disorder that some critics called an unacceptable risk.

But the study, still incomplete, could not prove whether the neuropathy was caused by d4T or by AIDS. It indicated that a lower dose of d4T - 20 milligrams twice a day - poses less risk of neuropathy.

But the advisory committee said that evidence was troubling because the patients in another study needed 40 milligrams twice a day.|