COMPOUND Q UNAUTHORIZED AIDS TRIALS

COMPOUND Q UNAUTHORIZED AIDS TRIALS are being reviewed by FDA, the agency announced in a June 28 "Talk Paper". The trials are being conducted in California with drug supplied by the San Francisco-based AIDS activist group, Project Inform. Responding to recent media reports of adverse reactions and one death associated with the treatment of AIDS patients with trichosanthin (commonly called Compound Q), the agency said it will be "investigating the Project Inform operation." FDA Offices of Regulatory Affairs and Drug Compliance, as well as the regional field office, are involved in the investigation. The agency is obligated to respond to the unauthorized trials if it wants to cut off black market-style drug testing situation similar to the use of Laetrile in the late 1970's. FDA approved Phase I trials with a tricosanthin derivative, GLQ-223, are currently being sponsored by Redwood City, California-based Genelabs ("The Pink Sheet" May 1, T&G-8). Pointing out that "several news reports have incorrectly referred to the compound used in unauthorized studies as GLQ-223," Genelabs said in a June 29 release that it is not "involved in any unauthorized testing." FDA explained that the "AIDS activist group initiated distribution of a tricosanthin-based preparation imported from China, supposedly to test its efficacy in AIDS patients." Furthermore, "Project Inform undertook this operation without an FDA sanction or approval, and has apparently been conducting it for a number of months," FDA noted. However, FDA remarked that "the scale and nature of the Project Inform operation are largely unknown to the agency." One of the 42 patients being treated by a California doctor with a form of tricosanthin extracted from Chinese cucumbers died of unknown causes. Project Inform defended use of the cucumber extract, citing FDA's "compassionate use" philosophy.