San Francisco Chronicle - Saturday June 24, 1989
Randy Shilts, National Correspondent

The announcement by Dr. Anthony Fauci, the AIDS coordinator for the National Institutes of Health, marked a major philosophical shift in the leadership of the government's sometimes controversial program to test new treatments for acquired immune deficiency syndrome.

In a San Francisco speech, Fauci said, "We cannot just rely on the traditional approach to clinical trials" of AIDS drugs.

Although Fauci said he favors the continuation of strictly administered clinical trials to determine the safety and effectiveness of new treatments, he also supports a new "parallel track" of studies for people who do not fit the rigorous criteria that orthodox tests usually demand.

"There doesn't seem to be very good reason to withhold drugs from individuals who can't be on the clinical trial," Fauci told the warmly applauding crowd at an HIV Awareness Week conference.

As director of the National Institute of Allergy and Infectious Diseases, the federal agency conducting the government's huge AIDS drug development program, Fauci has been at the center of the burgeoning controversy over treatment studies.

The strict standards used to select study subjects for promising new AIDS drugs often exclude a huge proportion of AIDS sufferers. Critics have chided this policy, saying the standards deny treatments to dying people even when these studies represent the only opportunity they have to receive potentially life-saving drugs.

In the past, federal researchers have resisted calls for allowing people to take new treatments outside the rigorous clinical trials, fearing that few would participate in controlled studies if they could get the drug without involvement.

Opening up a second track of drug testing, Fauci said, would give many more people access to treatments even while traditional clinical trials continued "to give us definitive answers about a drug's effectiveness."

Fauci said that drugs would be made available only when they had passed the first phase of testing to determine that they were not harmful and were "possibly effective." The second track of testing, he suggested, should include not only people with AIDS but HIV-infected people who had not yet developed any AIDS-related diseases.

He also cautioned that each study would have to be approved by the Food and Drug Administration as well as the investigators conducting the study and the drug's manufacturer.

"I can't order that it be done, because many parties have to be involved in this decision," he said, "but it's something we'll be talking about now on a case-by-case basis. I feel strongly that it will work."

Fauci said his agency already has launched negotiations for such expanded testing with Bristol-Meyers, the company that manufactures ddI, one of the most promising AIDS drugs now in development. He said he hopes that imminent second-phase tests of ddI would include the second track.

Fauci cited "constructive pressures" exerted on the federal government by advocates from AIDS organizations in the past year as one of the reasons e has changed his position and now favors the wider availability of AIDS drugs.

"I ask you to keep it up," he said.

In other remarks, Fauci cautioned the 500 participants at the conference that political pressures are mounting against continued increases in federal spending for AIDS research.

Noting that AIDS spending has risen rapidly in recent years, Fauci said resentment against further spending is rising from advocates of competing health issues.

"The doubling every two years of the AIDS budget may not be continuing," said Fauci, who is considered a likely appointee to the now-vacant post of NIH director. "I'm not saying that there's too much (AIDS spending), because I don't believe it's too much. It's too little . . . I think it's important you understand the mood."

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