Local Doctors to Conduct AIDS Research : Federal Program Will Give Wider Access to Experimental Drugs

In a major new direction for AIDS research, federally funded human trials of experimental AIDS drugs will be expanded to include local, community-based physicians, in addition to those who now conduct the traditional studies at large academic medical centers, federal health officials announced Tuesday.

“This is a serious attempt to have wider access to drugs at the community level,” said Dr. Anthony S. Fauci, director of AIDS research for the National Institutes of Health and director of the National Institute of Allergy and Infectious Diseases.

Fauci, who with other federal officials has come under recent attack by gay rights groups who believe that the government has been sluggish in making experimental drugs available, said the new community-based research program, in part, is a response to this criticism.

“It is very hard for suffering AIDS patients to understand how a clinical trial is being conducted,” he said at a press conference. “Their only concern is: ‘We need a drug. We need it right away.’ We are trying to do what’s best for them as quickly as possible.”

Likely to Raise Concerns

Fauci acknowledged that the new effort is likely to raise concerns in the research community and elsewhere that there will be a compromise of scientific integrity.

“There will not be,” he said, insisting that “the same rigorous attention” will be paid to monitoring the procedures of the new program as to the larger, more formal trials.

Dr. Daniel Hoth, director of AIDS programs for the National Institute of Allergy and Infectious Diseases, said the data obtained through the community-based research will be reviewed by outside experts who will “double check to make sure it is of high quality.”

Fauci said, however, that the focus of the new program will be in “asking different kinds of (research) questions,” since local physicians typically cannot perform the same kind of high-technology laboratory work as that conducted in the more sophisticated facilities. Local physicians will be engaged more in “clinical observation,” he said.

“It’s not going to be easy,” he said. “But this is not an easy disease.”

Experimental Drugs

Hoth said the new research likely will include many of the experimental but unproven AIDS drugs commonly in use now that are frequently obtained through the so-called AIDS “underground.”

The program, which will be funded at $6 million for its first year, was greeted with both enthusiasm and skepticism.

“This is welcome and long overdue,” said Urvashi Vaid, communications director for the National Gay and Lesbian Task Force. “It is something advocated for some time by the AIDS community.”

But Dr. Robert T. Schooley, an acquired immune deficiency syndrome specialist at Massachusetts General Hospital and Harvard University Medical School--who has conducted full-scale clinical trials for the federal government--said he is dubious of the research value of such a program.

“You just may not have control over all the variables that you would have in a carefully controlled trial,” he said. “The danger is that people may take different dosages of a wide variety of drugs--some of which the physicians know about, some of which they don’t--and that toxicity or beneficial effects will be mistakenly attributed to the drug supposedly under study.”

Rep. Henry A. Waxman (D-Los Angeles), chairman of the House Energy and Commerce subcommittee on health, called the new approach one of “great potential.”

“It can do research in areas that can’t be reached by medical centers and with patients who can’t be reached by academics,” Waxman said. “Some people are reluctant to leave the lab to look for answers, but the urgency of AIDS means that we must explore every possibility.”

Broader Representation

Fauci said the government hopes to include more infected “black and Hispanic persons and intravenous drug users, and more women at risk” of infection in the new research effort, groups where AIDS infection “is increasing rapidly.” Many of these individuals have “not had easy access to major medical centers,” Fauci said, and would be more likely to participate in community-based research because “they trust more their community physician.”

Fauci refused to estimate how many more people would be included in the new trials, which are not expected to begin until next summer.