Magazine article FDA Consumer

"Compound Q."

Magazine article FDA Consumer

"Compound Q."

Article excerpt

FDA has completed investigating an unauthorized study involving people with AIDS treated with trichosanthin, a plant derivative commonly called "Compound Q."

FDA began looking into this matter in June 1989 after the media reported that a large-scale unauthorized study of the drug was being conducted in California, New York, and Florida. Project Inform, a San Francisco-based AIDS activist group, was conducting this study of a trichosanthin-based preparation imported from China without FDA sanction or approval.

Trichosandiin is a plant protein that is being studied as a therapeutic agent against the AIDS virus. An FDA-sanctioned clinical study of GLQ-223, a refined form of trichosanthin, was started at San Francisco General Hospital in May 1989. This initial human study was designed to determine what dose levels of the drug can be tolerated by patients with AIDS, and has continued independent of the unauthorized trial.

After an initial assessment of the effects of the drug in die Project Inform study, FDA determined that the unsupervised use of trichosanthin was inherently dangerous, and consequently issued an import alert against the importation of trichosanthin.

The import alert, issued July 14, 1989, instructed FDA field offices to detain all incoming shipments of trichosanthin except those needed for the authorized San Francisco General Hospital study.

On Aug. 7, FDA's Center for Drug Evaluation and Research wrote Project Inform to formally outline many serious concerns FDA had about the study's safety and scientific reliability. …

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