Posted by Emily on October 21, 2001 at 17:26:15:
In Reply to: What is $ for? posted by Q on October 21, 2001 at 13:29:38:
I forwarded your post to Rick, the president of MAPS. Here is his reply:Emily,>The $50,000 is just a quick estimate, but is based on costs of the University of Arizona, Tucson psilocybin/obsessive-compulsive disorder study. Actual costs for a CH study would depend on the exact design of the protocol.For about $7,500, Ethan Russo and MAPS could prepare a protocol for a small pilot study with about 10 subjects and could work to obtain FDA approval and local Institutional Review Board (IRB) approval. If approved, about $2,500 would go for the psilocybin itself. The rest of the $40,000 would go for the costs of running the study such as time spent by the treatment team, the various evaluations that need to be conducted before, during and after treatment to measure for changes, any hospital costs, and follow-up. The money would also cover writing up the results for publication.If this starts to seem like a possibility, we can develop more definite cost estimates. To make psilocybin a prescription medicine for CH would require about $4 million or so for two large scale clinical trials with about 280 subjects in each study. However, positive results in a small pilot study may still be quite valuable to patients, both for the information developed and the legal protection it might provide to patients who used non-prescription sources of psilocybin. Perhaps a promising pilot study could help convince the National Institute of Mental Health (NIMH) to provide grant money for further research, or even motivate a pharmaceutical company to develop a similar drug for CH that could be patented.Rick DoblinRickMAPS@aol.com