On March 14, the US Department of Health and Human Services (HHS) approved the sale of research grade cannabis to an FDA-approved research protocol designed to look at treating veterans suffering from PTSD.
This approval signals a large shift in federal policy regarding research into the possible benefits of cannabis. Until Friday, no other FDA-approved medical marijuana study has ever cleared this hurdle. In fact, in the past 10 years, only one institution has conducted federally approved research on medical marijuana: a project created by the California legislature. In the past, only studies framed to look at the negative effects of cannabis were approved by HHS.
Generally, when a scientist wishes to conduct research on a controlled substance, they must first obtain FDA approval of the protocol, then receive a DEA license, and then purchase the substance from a licensed manufacturer of the chemical. In the case of cannabis, however, a separate review by HHS is necessary because the only licensed manufacturer is the federal government.
Dozens of FDA-approved research protocols have stalled because the federal government has refused to provide research materials to the studies. The political hurdles have been prohibitive and essentially blocked any chance at developing cannabis into a medication that can be prescribed by doctors. Currently, in states with medical marijuana laws doctors “recommend” cannabis, but cannot actually “prescribe” it due to the federal classification.
Currently, 18 states and the District of Columbia make some allowance for the medical use of cannabis. Patients, advocates, physicians, and state legislatures overwhelmingly agree that it’s time for a comprehensive federal policy regarding medical marijuana.
Meanwhile, the federal government has gone out of its way to prevent even researching whether cannabis is a viable medication. Friday’s approval is momentous and is the result of efforts by the Multidisciplinary Association for Psychedelic Studies (MAPS) spanning more than two decades.
MAPS, in collaboration with dozens of reform organizations, raises funds for these types of studies and assists researchers as they jump through the seemingly endless regulatory and political hoops necessary.
Suzanne A. Sisley, a clinical assistant professor of psychology at the University of Arizona College of Medicine in Tucson, has waited three years for approval. Her study design will look at the possible benefits of medical marijuana, the effect of different levels of THC, and any differences between routes of administration.
The study will still need to receive approval from the Drug Enforcement Administration, though it is expected to be approved as a matter of course.
The MAPS study will also require funding support.
“When it comes to researching the medical potential of Schedule I drugs,” said MAPS Founder Rick Doblin. “Privately funded medical marijuana drug development research has been the last domino to fall.”