The DEA has been active lately. A couple of weeks ago, it announced it would make a decision soon regarding rescheduling marijuana. On April 22, the Multidisciplinary Association for Psychedelic Studies (MAPS) announced the DEA had finally approved its application for the first approved study of smoked marijuana for effectiveness in treating PTSD. The study, as described by MAPS, is randomized, blinded, and placebo-controlled, and it involves providing military veterans suffering from PTSD with various strains of marijuana with different cannabinoid profiles.
Want to know what bureaucratic hell is really like? Let’s review MAPS’s arduous road in getting to this point.
In 2010, MAPS first applied to the FDA to approve the study, and it received that approval in December 2010. The study had already been approved by the University of Arizona Institutional Review Board. But the only way MAPS could actually get marijuana for its study legally was through the National Institute on Drug Abuse (NIDA) managed cultivation facility at the University of Mississippi. In order to get that product, the DEA had to approve. MAPS made its application, and the DEA sat on it. For over 5 years. In 2014, MAPS ran into a roadblock when the FDA approval came into question because the study hadn’t been commenced within 3 years of the initial approval. The Department of Health and Human Services, which includes the FDA, wasn’t done with MAPS either. Unlike other drugs, including other Schedule I drugs, HHS requires a secondary review of any marijuana research by another part of HHS called Public Health Services, which is an amalgam of various groups within HHS. This requirement for public health services was purely obstructive in nature, as we generally trust the FDA to approve research on its own, and the Obama administration officially got rid of it in June 2015. In March 2014, MAPS finally received its approval from the Public Health Services, after a whole lot of complaining. Still, it didn’t have DEA approval.
One month later, after receiving a recommendation from the Department of Health and Human Services, MAPS got word from NIDA that NIDA didn’t actually have the research-grade marijuana available for the study. This announcement was extra galling, because when the study was originally planned, the DEA had rejected its request to have a professor at the University of Massachusetts grow the cannabis. MAPS sued the DEA and lost because the DEA and NIDA claimed that the independent professor wasn’t necessary — NIDA had all the marijuana they needed with the same cannabinoid profiles. So, NIDA said that the marijuana wouldn’t be available until at least January 2015.
In June 2014, without warning, the University of Arizona fired Sue Sisley, the professor designated as the Principal Investigator of the study. There was no explanation, but it was assumed to be a political decision. Undeterred, Dr. Sisley and MAPS moved on and applied for approval of the study from Johns Hopkins University’s Independent Review Board.
In March 2015, NIDA finally provided marijuana cost and availability information for the study. All that MAPS needed at this point was for the DEA to grant a Schedule I license for the study site, and MAPS finally got that approval. It is expected to start getting NIDA marijuana within the next several weeks.
On the one hand, this a positive story about the tenacity of an organization and its lead researcher. But at its core, we are really looking at what a giant hellhole dedicated bureaucrats can create when they put their minds to it. There is no universe where a 6-year window between crafting a study and actually doing a study is reasonable. As long as our leaders take a laissez-faire stance toward research obstacles, these delays will be par for the course. The only way that this is ever going to change is through actual leadership. The direction that cannabis research takes in the future is dependent on four people: the President, the Secretary of Health and Human Services, the FDA Commissioner, and the DEA Chief. The Obama administration has not made access to marijuana research a priority. Let’s hope that the next administration does, because cannabis research matters.