Presentation on theme: "DEA/NIDA Obstruction of FDA-Approved Medical Marijuana Research Patients Out of Time Conference Asilomar, CA April 4-5, 2008."— Presentation transcript:
DEA/NIDA Obstruction of FDA-Approved Medical Marijuana Research Patients Out of Time Conference Asilomar, CA April 4-5, 2008
Valerie Corral Message She sends her greetings from her hospital bed, where she is recuperating from appendicitis operation yesterday. She said she is enjoying the morphine but would feel even better if she could be at the conference with the community she loves.
MAPS: Non-Profit Psychedelic and Medical Marijuana Pharmaceutical Company Since 1992, MAPS seeking to develop marijuana plant, smoked or vaporized, into FDA-approved prescription medicine. Progress has been obstructed by US Federal Government, making State-level reforms essential to respond to patient needs. MAPS’ failure is transformed into something beneficial when associated with larger movement.
Two Prerequisites for MAPS Drug Development Program 1. Vaporizers accepted by FDA for use in clinical research. Vaporizers are a non- smoking drug delivery device that can pass FDA’s risk/benefit analysis. Smoked high- potency marijuana may also pass. Vaporizer are now used in research. 2. Break NIDA monopoly on supply.
FDA is Not a Problem Since 1989, FDA has placed science over politics when it comes to psychedelic and medical marijuana research. Studies approved with MDMA, psilocybin, LSD, mescaline, DMT, ketamine, and marijuana. Only marijuana is supplied by a government monopoly. The monopoly is run by National Institute on Drug Abuse (NIDA), with a mission to study the harms of marijuana.
FDA Approves Research/ NIDA Blocks Research FDA has approved two MAPS-sponsored medical marijuana studies to which NIDA refused to sell us the marijuana. Dr. Donald Abrams-Marijuana/AIDS Wasting Study. FDA-approved 1994. Dr. Ethan Russo- Marijuana/Migraine. FDA-approved 1999.
FDA Approves CMCR Medical Marijuana Research FDA approved many studies funded by California’s Center for Medicinal Cannabis Research (CMCR) into therapeutic uses. However, CMCR’s studies are NOT intended to develop the marijuana plant into a prescription medicine. CMCR is almost out of money and has no active studies at this time.
FDA Approves Vaporizer Research MAPS/ CaNORML sponsored vaporizer research at Chemic Labs with low potency marijuana obtained from NIDA-supplied patient and high potency marijuana supplied by a Compassion Club routed through a DEA-licensed analytical lab. Donald Abrams conducted CMCR-funded clinical study comparing smoked v. vaporized marijuana and has used vaporizers in AIDS- related neuropathy study and current opiate study.
NIDA Refuses to Sell Marijuana for Further Vaporizer Research MAPS/ CA NORML have been trying since June 24, 2003 to purchase 10 grams of NIDA marijuana and import 10 grams of Dutch marijuana. Lawsuit v. NIDA July 14, 2004 arguing “Unreasonable Delay.” Lawsuit fails. NIDA finally rejects protocol in August 2005. Ignores our response filed in October 2005.
New Vaporizer Protocol New Protocol Submitted in January 2008. Lawsuit for “Unreasonable Delay” planned for August 2008, based on Steve Gust testimony in Craker case that NIDA/PHS review should take 3- 6 months. We launch suit after 7 months. We are making public this intention.
DEA Forced to Release Information to Congress March 8, 2008! 19 researchers have FDA and DEA licenses to conduct research with marijuana, all with marijuana supplied by NIDA. 13 conducting NIDA-funded drug abuse research. 6 licensed for CMCR-funded clinical research. However, no CMCR studies are active. Only Donald’s NIDA-funded study is active. NO DRUG DEVELOPMENT RESEARCH.
DEA Refuses to License MAPS- sponsored Production Facility Effort Began in 2000 to find ideal producer to apply to DEA for license. Prof. Lyle Craker, UMass Amherst, applies to DEA for license in June 2001. After 7 months, DEA claims to have lost Prof. Craker’s application! Photocopy of application resubmitted, DEA refuses to accept photocopied signature. One delay after another.
DEA: A Strategy of Delay Lawsuit against DEA for “Unreasonable Delay” in 2004. In response, DEA finally rejects application. DEA Administrative Law Judge Lawsuit begins in 2005, succeeds with February 12, 2007 recommendation that DEA license Prof. Craker, file formally submitted to DEA May 15, 2008. DEA delaying issuing final ruling to respond to recommendation.
DEA Forced to Release Information to Congress March 8, 2008! From January 1, 2001, to July 26, 2007, DEA Administrative Law Judges heard 101 cases. Time from ALJ Recommendation to DEA Final Ruing Fastest Time: 20 days Slowest Time: 2 years, 5 months, 4 days Average Time: 7 months, 29 days.
Pending DEA Final Rulings 11 Cases Waiting for Final Ruling Longest Time: 1 year, 10 months Shortest Time: 8 months, 11 days Average Time: 1 year, 1 month, 10 days Craker Time: 10 months, 19 days. Lawsuit for “Unreasonable Delay” would lose, probably require waiting at least 2 years, 6 months
Congressional Pressure 45 Members of US House of Representatives send letter to DEA urging that it accept the ALJ recommendation 2 Senators sent letter to DEA, Senators Kennedy and Kerry, no other Senators yet willing to add their names to the letter. Republicans-no way. Dems- not a priority.
Progress Possible in November If Democratic President is elected, we’re likely to see DEA issue Prof. Craker a license to start his growing operation. Then, $5-10 million and 5-10 years later, we’ll have the marijuana plant, vaporized and perhaps smoked, developed into an FDA-approved prescription medicine.