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

DATE: TUESDAY, September 13, 1994                   TAG: 9409130068
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A3   EDITION: METRO 
SOURCE: ASSOCIATED PRESS
DATELINE: SILVER SPRING, MD.                                 LENGTH: Medium

PROMISING AIDS DRUG A YEAR AWAY

An experimental drug awaited by AIDS patients won't be available outside limited clinical trials until at least the middle of next year, its maker said Monday.

The disappointing news about Hoffman LaRoche's saquinavir came as AIDS activists bitterly debated whether the government allows quick enough access to promising drugs - and whether its fast-track approval program sets up patients for snake-oil therapy.

``The system has not served us well,'' said Gregg Gonsalves of the New York-based Treatment Action Group. ``We don't have the data for people to make treatment decisions.''

``You're being protected to death,'' responded Dr. Thomas McGee of Los Angeles, whose patients beg for products like saquinavir that the government hasn't yet cleared for experimental use. ``There's a slaughter going on in this country every day ... and we're worried about data?''

But in the case of saquinavir, the first of a new family of potential AIDS drugs called protease inhibitors, the Food and Drug Administration isn't the holdup.

Saquinavir is so complicated to make that LaRoche simply won't have enough to give to any patients outside those in its strictly controlled clinical trials until at least mid-1995, said researcher Dr. Waijen Soo.

Even when it does open saquinavir to broad experimental use under the FDA's expanded access program, fewer patients will get it than have gotten any other experimental drug, he warned.

As LaRoche gets ready to ask the FDA for ``accelerated approval'' of the first protease inhibitor, which fights an enzyme key to HIV's replication, some activists want the FDA to revamp its fast-track drug program.

The FDA in 1992 agreed to license any AIDS drug that is safe and, in small studies, appears to fight the fatal disease through such indirect measures as immune system function. Even before that licensing, it lets dying patients who can't get into those small studies take promising drugs.

Those drugs are sold before anyone knows whether they actually prolong life, what dose is best, when to take them and in what combination with other drugs. So companies must agree to do the longer, larger studies necessary to discover all that - or pull the drug from the market.

But critics say that two years after LaRoche won FDA's first accelerated AIDS drug approval - for ddC in combination with the AZT drug - the company still hasn't done those studies.

That lapse prompted Gonsalves and some other activists to urge FDA to require better trials of saquinavir before it is cleared. They want a study of 18,000 patients, beginning during the accelerated approval process, to ensure the company follows through - a study that looks not at indirect measures but at actual survival.

But other advocates said that plan would mean an even longer wait for what may be the best breakthrough in AIDS drugs to date.

by CNB