MAPS is seeking to develop whole-plant marijuana into an FDA-approved prescription medicine. The FDA has approved a MAPS-sponsored protocol for evaluating the safety and effectiveness of five strains of smoked or vaporized marijuana for PTSD in 50 U.S. veterans suffering from chronic, treatment-resistant PTSD.
On April 28, 2011, MAPS submitted the protocol to the National Institute on Drug Abuse/Public Health Service for review. This redundant and politically motivated review is required for research on marijuana, but no other Schedule I drug. Unlike the 30-day limit on the FDA’s protocol review process, there are no time limits on the NIDA/PHS review, which could take about a year to review our submission.
On September 16, after a delay of four and a half months, the US Department of Health and Human Services informed MAPS that the five NIDA/PHS reviewers had unanimously rejected our planned study of marijuana for veterans with PTSD as currently designed. MAPS is now preparing a detailed response to the reviewers’ comments, and anticipates that even if NIDA does eventually agree to sell MAPS the marijuana, getting to that point will take extensive, time-consuming, and costly negotiations—while veterans continue to suffer.
See this in-depth article in the American Botanical Council’s HerbalGram to learn more about our efforts to initiate this research.
$10,000 needed for protocol development and approval / $10,000 raised
If NIDA/PHS approves the protocol, we will be seeking an estimated $200,000 to conduct the study.
For over a decade, MAPS and Professor Lyle Craker of the University of Massachusetts Amherst (who is represented by the American Civil Liberties Union) have been working to end the government’s monopoly on marijuana for research to open the door for privately funded studies.
The FDA has already permitted MAPS to sponsor research by Donald Abrams, M.D., into the safety of vaporized marijuana (HTML/PDF), but additional studies have been blocked by the National Institute on Drug Abuse’s refusal to sell us the marijuana required for the research.
A University of Mississippi lab growing marijuana under contract to NIDA is currently the only facility in the U.S. permitted to grow marijuana for research. NIDA’s mission to support research into the harms of marijuana has led it to refuse to provide marijuana to two FDA-approved MAPS protocols, preventing them from taking place.
On June 25, 2001, Craker applied for a DEA license to start a marijuana production facility at the University of Massachusetts-Amherst. On February 12, 2007, DEA Administrative Law Judge Mary Ellen Bittner issued a recommendation that Craker’s request be granted. On January 14, 2009, after a two-year delay, DEA Acting Administrator Michelle Leonhart rejected the recommendation.
The DEA has issued a final ruling rejecting the judge’s recommendation. Craker, with support from MAPS and the ACLU, and pro bono representation by Washington, D.C., law firm Covington & Burling LLP, are suing the DEA in the US Court of Appeals, First Circuit. The cost for these legal proceedings is estimated at $200,000. We are not actively seeking funds for the actual production facility at this time.
Medical Marijuana Fund