High Times reviews how MAPS’ FDA-approved study of medical marijuana for symptoms of PTSD in veterans is being blocked by the U.S. Public Health Service. The article notes that over 14 weeks have passed since the protocol was resubmitted to the PHS for approval, showing that this unnecessary review process hinders the advancement of science and medicine. “If the PHS review requirement was removed,” says MAPS-sponsored researcher Dr. Sue Sisley, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.“
Originally appearing here.
Veterans suffering from Post Traumatic Stress Disorder, commonly referred to as PTSD, rely on medical marijuana to treat a variety of symptoms including haunting nightmares and sleeplessness. The good news: Research to explore marijuana as treatment for PTSD was recently approved. The bad: Study cannot begin until the US Public Health Service gives scientists permission to buy pot.
Several months ago, a Food and Drug Administration and University of Arizona Institutional Review Board gave researchers approval to begin studying the effects of marijuana on US military veterans with PTSD. However, the study, which is being financed by the Multidisciplinary Association for Psychedelic Studies (MAPS), has been in limbo for the past 14 weeks because the Public Health Service has not authorized them to purchase “study” marijuana.
MAPS Executive Director Rick Doblin, Ph.D. says his team intends to investigate the safety and effectiveness of both smoked and vaporized marijuana on a group of 50 US veterans suffering from “chronic, treatment-resistant” PTSD. Interestingly, previous animal studies have suggested that marijuana effectually offers silence to an overactive fear system, but federal prohibition laws have kept scientists from conducting clinical trails on patients suffering from PTSD.
“This groundbreaking research could assist doctors in how to recommend treatment for PTSD patients who have been unresponsive to traditional therapies,” said Dr. Doblin.
Before the study can receive the official green light, the Public Health Service must first conduct a special review for the requested marijuana. Although there is a hefty supply of government marijuana allotted for FDA-regulated research, disbursement of this “science weed” is big brothered by the National Institute on Drug Abuse and the Drug Enforcement Administration, who have specifically mandated additional reviews be administered for study marijuana — no extra review is required for any other substance with a Schedule I classification.
After having their research rejected in 2011, MAPS resubmitted revisions to the project in October of last year, but they are not holding their breath for timely response. While the FDA is required to respond to inquiries within 30 days, the Public Health Service has no time constraints. Therefore, until the agency decides they are ready to respond, potentially life saving research is on hold.
“If the PHS review requirement was removed,” said Dr. Sue Sisley, who would lead the study, “we would gather information that could help veterans today. The stifling of medical research on marijuana stands in the way of our vets returning to a normal life.”