May 13, 2011
FDA Approves New PTSD Study with Medical Marijuana
By: David Jay Brown
Santa Cruz Patch
Columnist and MAPS Bulletin guest editor David Jay Brown summarizes what’s in store for medical marijuana research now that the FDA has approved MAPS’ planned study of marijuana for veterans with PTSD. The National Institute on Drug Abuse and the Drug Enforcement Administration have a history of preventing FDA-approved research from moving forward, but we’re trying to be optimistic that they’ll recognize the pressing need for this research and change their tune.
Originally appearing at http://santacruz.patch.com/articles/fda-approves-new-ptsd-study-with-medical-marijuana.
Several months ago, I reported on how the Santa Cruz Multidisciplinary Association for Psychedelic Studies (MAPS) was beginning the first experimental sessions in their second MDMA study on posttraumatic stress disorder (PTSD).
PTSD is an extremely difficult medical condition to treat, and it currently effects around 7.8 percent of Americans. It is caused by exposure to dangerous and highly stressful situations, which can result in lasting symptoms that include disturbing flashbacks, distressful emotions, panic attacks, and nightmares.
On April 28th the U.S. Food and Drug Administration (FDA) accepted MAPS’ protocol design for their study of cannabis as a treatment for symptoms of PTSD in war veterans. This approval from the FDA represents another important step forward in PTSD research, although there is still a major hurdle to overcome before the research can actually begin. The FDA stated that MAPS’ current protocol successfully addresses all of their concerns, as long as the researchers can obtain cannabis for the study.
Living here in Santa Cruz, with medical cannabis dispensaries popping up like fast food restaurants, you’d think that access to marijuana would be the easy part. However, there is only one place to legally obtain cannabis for a medical study in the U.S.—from the government itself, which has had an unconstitutional monopoly on the plant for research purposes since 1968. So, in order to obtain cannabis for the PTSD study, yet another government review process needs to take place.
The National Institute on Drug Abuse/Public Health Service (NIDA/PHS) also has to approve the cannabis/PTSD study before it can begin. Although the FDA has repeatedly demonstrated its willingness to evaluate studies on the basis of scientific merit, NIDA/PHS appears to continually position politics over science, and has consequently blocked medical marijuana studies from moving forward.
“This redundant review, which may take another year or more, is required solely because NIDA has a monopoly on the supply of marijuana for research. NIDA/PHS must review and accept the protocol before allowing us to purchase marijuana from NIDA. This process is biased from the start, since NIDA’s mission does not include exploring the potential beneficial uses of marijuana,” said MAPS Director of Communications Brad Burge.
MAPS has been trying for years to continue their medical marijuana vaporizer research, and although the FDA has approved that next study as well, the DEA has prevented them from conducting it by not allowing the researchers to obtain the necessary cannabis. (For more information about this, see the in-depth article that I wrote for High Times on the subject: http://www.maps.org/media/view/crop_blockers/) There is concern that this could happen again with the PTSD study that was just approved by the FDA.
According to Burge, many U.S. veterans already use medical marijuana to deal with their symptoms of PTSD. “MAPS is seeking to conduct the first clinical trial testing the use of the smoked or vaporized marijuana plant in PTSD patients. Now PHS/NIDA will decide if MAPS can obtain marijuana for 50 suffering veterans,” said Burge.
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