The Associated Press; 50 Rockefeller Plaza, New York, NY 10020 - Friday, November 21, 1997; 5:00 p.m. EST
John Hendren, Associated Press Writer

Drug makers are now testing 124 new treatments on patients, according to the survey of major drug companies by the Pharmaceutical Research Manufacturers of America. The Food and Drug Administration has approved a total of 50 AIDS-related drugs, including eight this year.

With AIDS drugs leading to the first-ever drop in the number of new AIDS cases in the United States last year, drug makers have come a long way since the first AIDS drug, Glaxo Wellcome's AZT, was approved in 1987, said Dr. John Siegfried, a Washington physician who treats AIDS patients and the industry group's head of medical affairs.

"Here we are ten years later, just a decade, and now there are 50 drugs either for the disease or for associated conditions," he said. "That's an unprecedented development."

The treatments under development include:

--40 anti-viral medicines and protease inhibitors, which have proven effective in reducing the amount of the virus in some patients.

--23 drugs to fight AIDS-related cancers, such as Kaposi's sarcoma.

--11 anti-invective medicines to fight opportunistic diseases, including a type of pneumonia that afflicts 8 out of 10 AIDS patients.

--5 gene therapies designed to genetically alter patients' cells to make them more resistant.

--12 vaccines, including the first DNA-based preventive vaccines. DNA is the principal carrier of genetic information in cells.

The federal Centers for Disease Control and Prevention said the drop in AIDS deaths and new diagnoses last year shows that powerful new drugs seem to be slowing down the virus that causes the disease.

In 1996, an estimated 56,730 people were diagnosed with AIDS, down 6 percent from the 60,620 new cases in 1995, according to the CDC. AIDS deaths also dropped 23 percent, from an estimated 50,140 in 1995 to about 38,780 in 1996. About 235,470 people were living with AIDS in 1996.

The CDC said powerful drugs such as protease inhibitors are apparently preventing HIV infection from progressing to full-blown AIDS, especially in patients who start taking the medicine early.

Many AIDS activists agree that pharmaceutical company scientists have made AIDS drugs a priority, but give drug makers a mixed overall review.

"I would give them an `A' for advances in the science and an `F' for fairness in pricing," said Daniel Zingale, executive director of AIDS Action in Washington.

"We do owe them a great debt of gratitude for the advances they've made in the fight against HIV and AIDS. The challenge is to make those treatments more available to people," he said.

Patients pay as much as $15,000 a year for the three-drug cocktails usually used to treat AIDS and other drugs to tackle opportunistic infections and other related problems.

Doctors who treat AIDS patients have eagerly called for more drugs, if only for variety. Because mutations in the virus reduce the effectiveness of drugs, doctors switch them, usually two or three at a time. But because only four protease inhibitors have been approved by the FDA, doctors are limited in the combinations they can prescribe. The fourth protease inhibitor, Hoffman-La Roche Inc.'s Fortovase, was approved this month. A Glaxo Wellcome drug now in the final stages of testing could bring the total to five.

Another closely watched drug in early development is an AIDS vaccine to be marketed by Wyeth-Ayerst called Genevax.

The new drugs are increasingly taking the place of new therapies. AZT, for instance, still has 27.5 percent of the market for so-called reverse transcriptase inhibitors, but Bristol-Myers Squibb & Co.'s competing drug, Zerit, approved in 1994, is rapidly catching up, with 22 percent.

New drugs are being approved more quickly in part due to an FDA program, which President Clinton renewed Friday, that uses contributions from drug makers to hire more officials to review drugs.

"The whole accelerated approval process ... was, I think, in many ways trail-blazed by the need to find AIDS remedies," said Dr. Frank Duff, associate clinical director at Hoffman-La Roche.

Copyright 1997/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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