DEA Allows Better Quality Cannabis For Research Purposes
Posted: July 16, 2021 in Blog Bloom
DEA Allows Better Quality Cannabis For Research Purposes
In an exciting development for cannabis research in the US, an announcement was made by the Drug Enforcement Administration (DEA) that it will allow cannabis researchers to use multiply sources as suppliers of cannabis material. For decades, only the low-quality cannabis grown at the University of Mississippi (UM) was given federal approval to be used for research purposes. In this article I will explain how the National Institute on Drug Abuse (NIDA) had a monopoly on the cannabis supply, the change in the DEA policy on who can supply cannabis for research purposes, what led to this change and its implications.
The NIDA Monopoly on Cannabis Material
Since 1968, the only federally approved source of cannabis for research purposes came from a 12 acre farm at the UM in Oxford, Mississippi. Known as the Marijuana Project, the program began when Dr. Coy Waller, then director of the Research Institute of Pharmaceutical Sciences at the UM School of Pharmacy’s National Center for Natural Products Research (NCNPR), negotiated a contract with the federal government to cultivate cannabis for research purposes. Its goal was to study all characteristics of the cannabis plant as part of its all-inclusive program on the research of natural products.
The Marijuana Project was initially funded by the National Institute of Mental Health (NIMH) and is currently funded by the National Institute on Drug Abuse (NIDA). The contract has been renewed every 3-5 years over the past 53 years with the understanding that the cannabis provided is of pharmaceutical grade. It is used for different studies, including FDA-approved clinical trials. However, the quality of the cannabis has always been and still is low-THC and of poor quality.
Just to give you an example of the subpar state of the cannabis material, here is what cannabis researcher, Dr. Sue Sisley, encountered when she received samples for her clinical trials with veterans with PTSD.
When she unwrapped the package of samples, she was shocked to find something which she described as “green talcum powder.” It didn’t look
nor smell like cannabis. It was full of stems and leaves and Dr. Sisley was very disappointed in the quality. When she analyzed the potency of the samples, she discovered they were not at the strength that she had requested. One strain which was supposed to contain 13% THC actually contained about 8%. Many samples were full of mold and yeast that far exceeded the levels established by legal-cannabis states.
In 2017, Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS) which partnered with Dr. Sisley on her clinical trials, described the NIDA cannabis source as “completely inadequate for drug development research.”
Dr. Sisley finally completed her initial clinical trials. The results suggested that cannabis is not as effective as was assumed. Both Dr. Sisley and Rick Doblin are convinced that the lackluster outcome was due to the poor quality of cannabis samples. She is moving ahead with Phase 2 of her trials using better quality cannabis imported from outside the US.
The UM Farm has earned the reputation as the cultivator of some of the “worst cannabis in the world.” It has been the subject of lawsuits, disputes between academics and very unflattering headlines.
The Change in DEA Policy
For years, there have been broken promises by the NIDA and the DEA to expand the sources of federally approved cannabis. Finally, the two agencies are ending the federal monopoly by granting cultivator licenses to other organizations.
Cannabis growers were invited to submit applications as far back as 2016. Absolutely nothing happened until 2019, when then Attorney General Bill Barr announced that the DEA would start reviewing the applications. In May, 2021 the DEA finally announced that it had reviewed the grower applications and was ready to award licenses by issuing a “Memorandum of Agreement” (MOA) to several applicants. Up to 15 growers may be awarded licenses, subject to a reassessment by the DEA.
At least 3 organizations have received MOAs:
Groff North America in Red Lion, PA, Dr. Steve Groff, founder
Scottsdale Research Institute (SRI) in AZ, Dr. Sue Sisley, President
Biopharmaceutical Research Co. (BRC) in Castroville, CA, George Hodgin, CEO and former Navy Seal
Ramifications of the New DEA Policy
This announcement is being met with nothing but positive responses:
Research institutions, biotech firms and other private companies may now position themselves as reliable, safe sources for both research and cultivation.
Provides a quality of product for research organizations comparable to the supply enjoyed by both medical and recreational users.
Will create many new jobs in the cannabis industry while simultaneously beginning the development of invaluable American intellectual property.
A real-world cannabis supply will now be available for clinical study. The need for good research data based on the analysis of high-quality cannabis is urgent. This is a step in the right direction to address the concerns of cannabis legalization opponents who claim that there is a lack of comprehensive data that corroborates the numerous medicinal benefits of cannabis.
Due to the NIDA monopoly, the only studies in the US have been observational. Using high-quality cannabis will open the door to dependable clinical studies from which research data can be gathered.
May motivate more doctors to recommend medical cannabis, boosting sales.
Competition in the marketplace by new participants should lead to rapid innovation in cannabis healthcare products.
Scottsdale Research Institute Lawsuit
In 2020, Matthew Zorn, a Houston-based attorney, filed a Freedom of Information (FOIA) lawsuit on behalf of Scottsdale Research Institute against the Department of Justice (DOJ) and the DEA. Due to the lawsuit, the DOJ released a memo from 2018 that had been confidential. The conclusion was that the DEA’s long-standing policy on cannabis research violated federal law, as well as U.S. treaty obligations.
This policy change will be a massive step forward for the entire cannabis industry!
leafly.com, DEA Finally Ends Fed Monopoly on Schwaggy Research Grade Cannabis, Bruce Kennedy, May 12, 2021
leafly.com, Photos Prove Government Grown Cannabis Is Basically Ditch Weed, Ben Adlin, March 13, 2017
pharmacy.olemiss.edu, The Marijuana Project
marijuanamoment.net, DEA Announces It Will Finally Take Action on Marijuana Grower Applications, Kyle Jaeger, Aug. 26, 2019
mjbizdaily.com, DEA Close To Allowing Companies To Grow cannabis For Scientific Research, Omar Sacirbey, May 18, 2021
leafly.com, New PTSD Study Finds Cannabis Safe But Not As Effective As Assumed, Bruce Kennedy, March 18, 2021