sâmbătă, 24 mai 2008
Amazingly, MAPS is the only organization that is attempting to resolve the controversy over medical marijuana via the FDA research route.
MAPS' goal is to initiate and fund a serious drug development research program aimed at proving to the satisfaction of the FDA that marijuana is safe and efficacious for specific medical uses and should become a legal, FDA-approved prescription medicine.
Prior to initiating a serious drug development research program that would require an estimated $5 million and 5 years, MAPS first needs to obtain access to an independent source of supply of marijuana that is legal for medical research. MAPS, in association with Prof. Lyle Craker, UMass Amherst Dept. of Plant and Soil Sciences, is in the midst of what is now a six year struggle seeking DEA permission to establish a medical marijuana production facility to grow high- potency marijuana for FDA-approved research.
At present, the National Institute on Drug Abuse (NIDA) has a monopoly on the supply of marijuana that can be used in research, provides low-potency material, and only makes it available to projects it approves. MAPS needs its own independent source of supply since NIDA's arbitrary and lengthy review process for providing marijuana essential to research can derail any drug development plan. NIDA has refused to supply marijuana to two MAPS-sponsored protocols that the FDA had already approved.
Despite NIDA obstructionism, MAPS has been able to provide some analytical data about the constituents of the marijuana vapors produced by vaporizers to Dr. Donald Abrams, UC San Francisco. Dr. Abrams has used this data as part of his successful application to FDA to conduct a study evaluating subjective effects, cannabinoid blood levels, and carbon monoxide levels in subjects who smoke marijuana and then at a different time inhale marijuana vapors from a vaporizer.
The initiation of FDA-approved clinical research with a marijuana vaporizer was MAPS' second prerequisite to starting a serious drug development research program, so that clinical research could be conducted both with smoked and vaporized marijuana. That way, we'd be able to produce data that would compare the risks of smoking v. vaporization and could address the Institute of Medicine's recommendation for a non-smoking delivery system with a system that works with the plant itself. At present, only the ending of NIDA's monopoly on supply (which it doesn't have for MDMA, LSD, psilocybin or any other Schedule 1 drug) stands in the way of an active effort to develop marijuana into an FDA-approved prescription medicine.