San Francisco Chronicle - Wednesday, June 7, 1989
David Perlman, Chronicle Science Editor

For the first time in the history of modern medicine, organized, militant and sophisticated patients and their supporters are taking control over their own experimental treatments.

Nearly 150 different AIDS drugs are being discussed in crowded research sessions here at the fifth International AIDS Conference. Scientists are vitally interested in tests in which volunteer patients are randomly assigned to take either a specific drug or an inert dummy drug called a placebo to assess the drug's effectiveness.

But evidence shows that many patients are thwarting the scientific tests by running their own tests and taking their own medications.

For example, a government-sponsored long-term trial of AZT, the only drug yet licensed to treat AIDS, involves more than 3,000 asymptomatic volunteers at 33 medical centers. The test - which should show whether patients infected by HIV, but who show no AIDS symptoms, can be protected against the developing the disease - gives some of the subjects AZT and others placebos.

But in many cases, according to Nancy Dubler, an attorney at Montefiore Medical Center in New York, the volunteers are having their medications analyzed to find out what they are taking. MANY "DROPPING OUT'

"And if they find out they're on placebo, many are just dropping out," Dubler said.

Dr. Anthony Fauci, who is directing the nationwide AZT test, insisted, however, that the trial is proceeding on schedule, and several research reports here disclosed yesterday that already many of the asymptomatic subjects are showing serious resistance to the drug, while in others the continuing dosages are proving toxic.

For those patients, ironically, the placebo is proving much more helpful than the AZT, Fauci noted - proof that under certain conditions placebo-controlled tests are essential.

In an interview here, Fauci, who oversees most of the nation's AIDS drug trials as director of the National Institute of Allergy and Infectious Diseases, proposed a "two track" system whereby AIDS patients who might be ineligible for the trial of a safe new drug, or who might not want to commit themselves to following a trial's requirements, would be allowed access to the drug under appropriate medical supervision.

Pressure for change has come from physicians as well.

Dr. Donald Abrams of the University of California's AIDS center at San Francisco General Hospital led the first trials of the drug pentamidine in aerosol form to prevent recurrent attacks of the deadly Pneumocystis carinii pneumonia.

When there is no alternative to a given drug, Abrams believes, then placebos may be essential in the early trials, but in the case of the deadly opportunistic infections like fungal and parasitic diseases, where standard drugs are already available, the new ones specifically designed for infections in AIDS patients should need no placebos at all, Abrams argued.

The major pressure for speeding AIDS drug trials has come from well-informed people in organizations such as New York's ACT-UP, whose more militant members are doing most of the shouting and disruption here.

A PLAN TO SPEED ACCEPTANCE The organization made public a detailed "new model" for AIDS clinical trials yesterday that would speed acceptance of drugs if they have already been tested in other countries whose drug regulations are comparable to America's.

The plan would bar placebo trials for drugs used against the opportunistic infections and would initiate early trials for efficacy as soon as safety has been reasonably established.

Finally, the organization proposed, community-based groups of physicians should be allowed to test the efficacy of new drugs widely as soon as pilot studies show they may prove effective.

Always watch for outdated information. This article first appeared in 1989. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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