Answers
06/28/1989

<TITLE>Unauthorized AIDS study </TITLE>
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                                June 28 1989

                FDA STATEMENT ON UNAUTHORIZED AIDS DRUG STUDY 
    In the past few days there have been several media reports of a death 
associated with an unauthorized use of trichosanthin, a plant derivative
commonly called "Compound Q," in people with AIDS.  The following 
information can be used to answer questions:
    Trichosanthin is a plant protein, which researchers think may be an 
effective 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 is designed to test 
the safety of this drug's use in treating AIDS patients, and particularly to
determine at what dose levels the drug can be tolerated.
    According to media reports, Project Inform, a San Francisco-based AIDS
activist group initiated distribution of a trichosanthin-based preparation
imported from China, supposedly to test its efficacy in AIDS patients.
Project Inform undertook this operation without an FDA sanction or approval,
and has apparently been conducting it for a number of months.  There have 
been several media reports that the death of one patient and the serious
adverse reactions of other patients participating in this informal study
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have been either directly or indirectly linked to this trichosanthin-based
product.
    FDA is conducting an investigation of the Project Inform operation.  The
scale and nature of the Project Inform operation are largely unknown to the 
agency.  The safety procedures in this study are not known and the exact
circumstances surrounding the death and other adverse reactions reported to 
have occurred in this trial have not been ascertained.  Questions also
remain about the exact composition of the product and whether it was
illegally imported into the country.
    The agency feels that the concerns raised by this operation point out 
the need to conduct clinical studies in a scientific manner, that includes
careful study design, institutional monitoring mechanisms and consistent
reporting channels.  Such studies assure the acquisition of good clinical 
data in the shortest possible time, and ensure the safety of patients.
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