FDA Asks AIDS Group to Halt Test of Chinese Drug

The U.S. Food and Drug Administration has asked AIDS activists to “discontinue” an unsanctioned clinical trial of a highly touted AIDS drug from China, but has stopped short of taking steps to halt the study.

In a letter released Tuesday, a senior FDA official told the study’s organizer, Martin Delaney of San Francisco-based Project Inform, that he “should discontinue any further unapproved experimentation” with the drug and “not initiate any new use” without authorization. The drug is known as Compound Q or trichosanthin.

The letter, from Dr. Carl C. Peck, the director of the FDA’s Center for Drug Evaluation and Research in Bethesda, Md., was the agency’s first formal response to the trials. In June, the FDA said it would investigate reports that one patient in the 60-patient study had died and others had suffered serious adverse reactions. The investigation is continuing.

Peck expressed concern about the safety of the participants and the potential “variable purity” of the Chinese drug. The presence of contaminants might increase the risk of toxicities and “make it difficult or impossible” to interpret the results of the trial.

Brad Stone, an FDA spokesman, said the agency will await Delaney’s response to the letter before considering further actions.

“I don’t read this as an order,” Delaney said in a telephone interview. “I read this as an opinion. In any case, it is a moot point because our treatment protocol has been over for some time.” Delaney said patients are no longer receiving additional doses of the drug but are being evaluated by physicians to determine whether the drug has helped them.

Project Inform believes that official trials of AIDS drugs are far too slow. Under the group’s direction, nine physicians in Los Angeles, San Francisco, New York and Miami treated patients with a series of three weekly infusions of Compound Q.

Underground activists imported the drug from China. The drug is a purified extract made from the root tubers of a Chinese cucumber, Trichosantheses kirilowii .

In test tube experiments, trichosanthin appears to selectively kill human immune system cells that are infected with the human immunodeficiency virus, the cause of AIDS.

On July 14, the FDA issued an import alert for trichosanthin, which means that all unauthorized shipments will be detained by customs and postal officials.

In the letter, Peck invited Delaney to meet with agency officials to discuss a possible role for community groups in testing the official version of the agent.

That version is known as GLQ-223. It is manufactured by Genelabs Inc. of Redwood City and is undergoing preliminary human toxicity trials at San Francisco General Hospital.

“We stand ready to meet immediately with the Project Inform trichosanthin investigators and possibly representatives from the manufacturer,” Peck wrote.

Delaney said he would meet with FDA officials the first week of September, when Project Inform will also present them with the results of its trial.