San Francisco Chronicle - Monday July 3, 1989
Randy Shilts

The occasion of this future shock was the revelation that Project Inform, a local AIDS treatment information and lobbying group, has organized its own clandestine tests of the promising AIDS drug Compound Q wholly outside the normal channels of government approval.

The bold challenge to the authority of the Food and Drug Administration immediately provoked an FDA investigation and a round of condemnations from the mainstream researchers at San Francisco General Hospital who are conducting the only approved Q trial.

There was more show than substance to all this official wringing of hands. The FDA has conceded that members of its staff already knew about the secret trials, long before the story hit the front pages. And so did researchers at the National Institutes of Health and San Francisco General.

This didn't mean that these august scientists necessarily approved of the "renegade research," as organizers have called it, but they were as eager as anybody to know whether Q actually works.

What is remarkable about the trial is that it represents action on an issue over which there has been only talk before. For years, AIDS lobbyists have talked about the glacial pace of drug testing; for years, researchers, FDA officials and NIH scientists have talked about the need to perhaps find faster ways to conduct drug tests.

By actually going out and doing something, however, Project Inform and its charismatic spokesman, Martin Delaney, have sent shock waves through the scientific establishment and have dramatically advanced the debate over what precisely should be done to develop AIDS treatments faster.

The renegades argue that they were merely dealing with reality. From the day researchers announced 10 weeks ago that Compound Q appears to hold amazing anti-HIV properties when studied in the test tube, it was clear that Q would become the hottest item in the AIDS drug underground.

It has all happened before.

Reports in 1984 that ribavarin appeared to help AIDS patients sent thousands scurrying to Mexico, where the drug could be purchased legally. In 1985 and 1986, the fad treatment was AL-721, which could be made in a home blender. In the past few years, a sophisticated network of "buyer's clubs" have imported millions of doses of dextran sulfate from Japan.

All these drugs had one thing in common: Nobody knew if they really worked. What terrified AIDS groups was that Q had the potential to be far more toxic than any of the earlier imports. There was the very real threat of people dying from self-medication.

The response of the medical establishment to these drug fads was to tell anxious AIDS patients to just say no and wait for traditional scientific tests to run their course. For tens of thousands of HIV-infected people, particularly those with late-stage AIDS, this was an unsatisfactory answer. Many wouldn't be alive when those tests were completed. The implacability of both sides is what set the stage for this week's confrontation.

What's ironic is that the challenge to orthodox science comes at a time when once-stubborn federal agencies are shifting toward speedier testing and release of drugs. Dissidents like Delaney and the articulate Mark Harrington from New York's AIDS Coalition to Unleash Power (ACT UP) now have routine access to top officials at the NIH and FDA.

The medical establishment has not moved the full nine yards AIDS organizers would like, but the FDA and NIH are taking positions today that would have been unthinkably radical just 12 months ago.

"There were nasty, vicious and ugly fights over these issues for the past two years, but a new consensus is on the verge of developing," says David Corkery of the American Foundation for AIDS Research. "Everybody's talking to each other at last. I hope it doesn't get destroyed now."

The FDA will determine the fate of that consensus this week when it issues its official response to the underground testing. The agency has the upper hand with a broad array of legal powers at its command.

Pressure on the agency undoubtedly will be great. Some mainstream doctors are appalled at the trials' audacious challenge to governmental and scientific authority. The Project Inform tests have apparently been conducted with high medical sophistication, but this doesn't guarantee that future rebel efforts will be done with equal care.

The renegades, however, are not without resources of their own. No matter what the FDA does about the Project Inform trial, future underground testing will persist, and undoubtedly proliferate, as more doctors and patients become willing to buck the system.

The growing cadre of extremely militant AIDS organizations, such as ACT UP, also have made it abundantly clear that they will not stand idly by during a crackdown on Delaney or other AIDS organizers.

Moreover, in a rift between government scientists and the AIDS community, patients could use their ultimate weapon and simply decline to participate in the official, approved studies, throwing the entire drug testing process into turmoil.

Heavy-handed government action, therefore, could polarize the AIDS world. Right now, everybody, from Project Inform to the FDA, seems ready to let the issue cool down. Whether such calm heads prevail in the weeks ahead could well shape the future policy course on the crucial issue of AIDS treatments.

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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