51 years ago the U.S. government named the University of Mississippi as the only legal supplier of medical cannabis. Accordingly, generations of scientists were forced to obtain a highly coveted DEA Schedule 1 research license merely for the privilege of being able to purchase whatever cannabis the University decided to provide them.
Three years ago the DEA announced it recognized researcher demand for a larger and diverse variety of cannabis and that it would soon be increasing the number of federally authorized growers. Since then, exactly zero additional growers have been named despite over 30 applications.
Three weeks ago Dr. Sue Sisley filed a lawsuit against the DEA, alleging that the government enforced monopoly at the University of Mississippi was harming researchers by limiting legal access to a plant, in turn harming patients who would remain without potentially critical clinical research information and access to potential new medicines.
“Maintaining only one federally legal drug supply for any clinical trials in the US has been a huge impediment to research because it’s not allowing scientists access to necessary options. We can’t just study from one supplier who seems to be limited from purchasing new genetics. And when there’s a monopoly for this many decades, it tends to breed apathy. There’s no real drive to respond to the public, to be responsive to the demands of scientists, no real need to innovate in the direction of what patients want.”
Dr. Sisley is well-positioned to file the suit. As one of the few people to hold two different DEA Schedule I licenses as researcher & analytical lab, Dr. Sisley has been carrying out the only FDA-approved randomized controlled trial in the world examining safety/efficacy of whole plant marijuana in combat veterans with severe post traumatic stress disorder, PTSD, for several years.
As the PTSD study concluded and Dr. Sisley began preparing to publish the results, she unblinded the data and quickly came to believe that the quality of cannabis provided by the University of Mississippi had negatively affected the study’s efficacy data.
“Most scientists end up with this mishmash of different strains (including stem sticks, leaves etc) – all of it seems to get thrown into a grinder in overzealous effort to standardize the study drug batches for clinical trials. I’m arguing that by doing that, they’re overprocessing the plant and decimating the natural efficacy contained in the flowering tops. Further, in controlled trials we issue patients the study drug by weight.
So if the weight of study drug is being augmented with this extraneous plant material instead of just the dry flower/bud,” Dr. Sisley explained, “common sense suggests how this dilution could harm the outcomes of efficacy data”.
Without the ability to legally obtain cannabis from a range of federally legal suppliers who would be motivated to provide better options, service and quality, and without specific access to a diverse variety of strains (more similar to the thousands of phenotypes readily available throughout the US regulated markets) that could be studied to see if they offered varying treatment potential, Dr. Sisley maintains that scientists are unjustly handcuffed.
While the lawsuit is focused on breaking of the University of Mississippi’s supplier monopoly, Dr. Sisley knows firsthand that this issue is only a strand in a larger web of challenges that cannabis researchers face.
In addition to extraordinarily limited access to research material, studies proposing to examine the potential harms of cannabis are often quickly approved by the government, while studies aimed at the efficacy of cannabis are routinely stalled.
And by refusing to provide any whole cannabis flower which can eventually be sold as a prescription medicine to researchers for study in FDA PHASE 3 Trials, the government is disadvantaging those interested in researching whole plant treatments in favor of large pharmaceutical companies who are only looking to isolate specific patentable cannabis compounds.
Dr. Sisley recognizes that even if her lawsuit is successful the results will still be a long time coming. It will take newly DEA licensed BULK MANUFACTURERS years to get up and running, all while other countries with already fully developed medical cannabis supply chains like Canada, Israel, Australia, and others continue to pull ahead of the U.S. in the race to take the lead in clinical cannabis medicine research.
“That’s why I spend so much time educating about the limitations of this monopoly and the fact that if we could ever license other growers for research and have options for scientists, it could create a renaissance of cannabis research in the US, which is we could, you know, regain our rightful place at the helm of the most important cannabis clinical trials in the world.”
While the lawsuit progresses through the court system Dr. Sisley is actively gearing up for a phase two of the PTSD study, including looking for a private partner to help her redo the study with real world cannabis flower.
“I believe that efficacy data would be significantly different if these patients were allowed to self-titrate real world cannabis,” explained Dr. Sisley.
And true to her word, she’ll be continuing her mission to educate others about the current medical cannabis monopoly by delivering one of the keynote addresses at the Microscopes & Machines conference, taking place in Los Angeles on July 27. To see Dr. Sisley along with a diverse array of other speakers and cannabis experts, click here for tickets.