Important Articles From Project Inform *****

The October 1987 issue of PI Perspectives, the newsletter of Project Inform, has two articles which are proving
influential.
"Evaluating New Treatment Alternatives" urges a cautious approach to proposed treatments. It provides checklists of questions for rationally evaluating the available evidence of efficacy, when there isn't full scientific proof. No available
drug, mainstream or alternative, gets a perfect score. The point is not to reject them all, but rather to weigh the
evidence properly.
"False Hope: Smoke and Mirrors From the FDA" reviews the new rules approved by the FDA in June of this year, rules supposed to provide easier access to experimental treatments which were safe and probably effective, although they had not yet achieved full mass-market approval. The article analyzes why these rules have failed to work.
A section titled "Questions for the FDA" caused annoyance at that agency, as reporters from around the county have found that the FDA is indeed unable to answer eight simple questions which Project Inform suggested. Some of the questions are:
* What is the procedure by which a physician may apply to receive an experimental drug for a life-threatened AIDS or ARC patient? Where can we get the forms?
* Are there any drugs for AIDS or ARC, immunomodulators or antivirals, that the FDA feels would currently be eligible for release under the new regulations?
* What criteria will be used to determine the effectiveness of a drug so that it can be released under the
new regulations Where are those criteria spelled out?
* What, if any, role is there for the private physician under the new regulations?
To obtain the October issue of PI Perspectives, and to get on the mailing list for future issues, call Project Inform,
(800) 822-7422 U.S. outside of California, (800) 334-7422 in California, or (415) 928-0293 from anywhere.