San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - 15 March 1996, p.B1
Carl T. Hall, Chronicle Staff Writer

The U.S. Food and Drug Administration took only 42 days to act on Merck's application to market Crixivan, one of the most potent anti-virals in a new class of AIDS treatments known as protease inhibitors.

A similar drug from Abbott Laboratories won rapid approval on March 1. The FDA has put key AIDS treatments on special fast- track status.

The new treatments "are perhaps the most important AIDS drugs to have come along during the entire course of the epidemic," said Dr. Steven Deeks, who helps direct AIDS clinical trials at San Francisco General Hospital.

Crixivan represents the first AIDS drug to hit the market from Merck, one of the world's biggest pharmaceutical makers. The New Jersey manufacturer wasted no time making its presence felt once the FDA flashed the green light.

Merck had been expected to price its drug about the same as competing ones from Abbott and Hoffman-LaRoche. Instead, Merck said it will make Crixivan available to pharmacies by March 25 at a wholesale price of about $12 a day, or $4,380 for a year's worth of capsules.

"They kind of surprised everyone by coming in with some very aggressive pricing," said Ron Baker, director of treatment education and advocacy at the San Francisco AIDS Foundation.

By comparison, Abbott has been charging about $17.80 a day wholesale and Roche gets about $15.90 a day for its protease inhibitor.

The most widely used AIDS treatment, AZT, which has been on the market since 1987 and works on a different part of the AIDS virus, costs about $7.75 a day.

Yesterday's FDA announcement came nearly 10 years after Merck researchers first began to track the obscure biological machinery by which the AIDS virus spreads. Studies focused on the role played by the so-called protease enzyme found in HIV.

By attacking that enzyme, Crixivan and the two similar drugs already on the market may help reduce the amount of virus in the blood. The most effective AIDS treatment now appears to be a protease inhibitor used in combination with one or more of the other drugs already approved.

Many doctors say more research is needed to be sure just how Crixivan will fit into the AIDS arsenal.

"It's very exciting that we now have three new members of this new class of drugs. But what we need to do now is learn how to use them," said Dr. Donald Abrams, a top AIDS researcher at S.F. General.

Some studies suggest that misusing the drugs -- giving them too soon or in the wrong combinations -- may put patients at risk of developing strains of the virus that resist treatment.

The FDA portrays its rapid review of AIDS drugs as evidence that Congress doesn't need to reform the agency. In fact, some researchers worry that drugs are getting through without enough scrutiny.

For Crixivan, the FDA relied on studies showing the drug works to block replication of the AIDS virus, thus reducing the amount of virus in the blood. It will take more study, Abrams said, to determine how this translates into real benefits for people with the disease.

"We know a lot about how the drug affects the virus, but we know a lot less about what the drug does to patients," he said.

But most doctors praised the FDA for its fast pace on the AIDS front, saying there's little to be gained from waiting until all questions are answered.

"There are enough body bags stacked up already. We need better drugs," said Dr. James Kahn at University of California at San Francisco.

Despite high marks on the AIDS front, demands to revamp the FDA will not vanish.

Health care device manufacturers continued to press for legislative changes yesterday in the agency's review process, saying life-saving technology is still bogged down in red tape despite the recent string of high-profile AIDS drug approvals.

"We're not getting the priority treatment in terms of where the FDA is putting its resources," said Alan Magazine, president of the Health Industry Manufacturers Association in Washington, D.C.

------------------------ LONG ROAD FOR AIDS DRUG

Merck & Co.'s new AIDS drug, Crixivan, won rapid approval once it got before the FDA, but the drug took nearly 10 years to develop:

-- January 1987: Merck scientists begin studying the so-called protease enzyme in HIV as a possible way to attack the virus that causes AIDS.

-- July 1988: Study shows that HIV may not spread if the protease enzyme is inhibited. Search continues for an effective drug at Merck and other companies.

-- March 1990: An early protease-inhibitor candidate drug fails, but research paves the way for development of Crixivan.

-- February 1993: Safety trials begin.

-- Jan. 30, 1996: Study results show Crixivan, when taken with two other AIDS medicines, reduces the level of the virus in the bloodstream.

-- March 1: FDA advisory panel recommends Crixivan.

-- March 13: Crixivan approved.
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