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.