FDA Reportedly Aware of AIDS Drug Test

SAN FRANCISCO —  The organizers of unsanctioned clinical trials of the touted AIDS drug Compound Q said Wednesday that federal officials as well as scientists conducting official tests of a similar drug were aware of the underground experiment before it became public this week.

“Officials of the (U.S.) Food and Drug Administration were apprised of what we were doing,” said Martin Delaney, co-director of Project Inform, which is conducting the underground trials. “It doesn’t mean they agreed with it, or supported it, but they were interested to know our results. That’s true of officials at the National Institutes of Health as well.”

Delaney also told the crowded press conference here that, “As recently as a week ago, Dr. (James) Kahn at San Francisco General Hospital told us that because of our findings, their trial had been speeded up, that they were now going to higher doses, and that he hoped they’d be able to wrap it up by Sept. 1.”

The FDA announced Tuesday that it was launching an investigation of the underground research program after the death Saturday of one of 42 patients who had been injected with the drug. Another patient in the study committed suicide, and a handful have suffered serious side effects. Many have also shown considerable improvements based on laboratory tests, doctors and some patients said.

“It was only after this very unfortunate death that everyone headed for the hills and acted like we were some kind of monsters,” Delaney said.

An FDA spokesman, Brad Stone, said Tuesday that the agency’s investigation in part will look into “whether a contact (by Delaney to the agency) was made, and how in-depth it was.”

FDA officials could not be reached Wednesday for comment.

Kahn, who has denounced the renegade researchers, was not immediately available for comment.

A spokeswoman for San Francisco General issued a statement on behalf of Dr. Michael McGrath, the developer of the official version of the drug, in which he confirmed that he had been in contact with unspecified AIDS activists.

“I have received infrequent telephone calls from AIDS activists giving anecdotal rumors that some form of Q was being administered to people in the U.S.,” said McGrath, adding that he did not give the activists any advice on unauthorized trials.

He did confirm, however, that Genelabs Inc. of Redwood City, the manufacturer of the official version of the drug, “conducted a preliminary test (of Compound Q imported from Shanghai) and found it to be substantially the same as GLQ-223,” the official version of the drug.

Compound Q, or trichosanthin, is a plant protein derived from the root tuber of a Chinese cucumber. GLQ-223 is a synthesized version of the drug. The substance has stirred considerable excitement among researchers because of its ability to seek out and kill infected cells known as macrophages in test tube experiments.

Delaney said Wednesday that he welcomed the controversy that has surrounded the underground experiment, which is being conducted by doctors in San Francisco, New York, Los Angeles and Miami.

“It is time to have a national debate on whether (the scientific research establishment) should do things differently” in confronting the AIDS epidemic, which has already killed about 55,000 Americans.