On Monday morning, the prospects for federally sanctioned medical cannabis research brightened dramatically with news that the Drug Enforcement Agency (DEA) finally plans to move forward with processing applications for additional pot growers. This means that folks like Dr. Sue Sisley — who filed the lawsuit against the DEA that led to Monday's decision — will no longer be forced to rely on the sole government-approved cannabis cultivation facility out of the University of Mississippi, under the auspices of the National Institute on Drug Abuse (NIDA).
For the past four years, Sisley, in partnership with the Multidisciplinary Association for Psychedelic Studies, has been doing clinical research on veterans with PTSD, who smoke cannabis to treat their symptoms.
A rather dry announcement published in the Federal Register on August 26 essentially served as a win for Sisley, who recently confided to Civilized that she expected the opposition's lawyers to “continue to extend and delay this for as long as possible” in advance of an August 28 court-mandated deadline for the DEA to explain its failure to process applications.
Instead, the Register notice was paired with a press release from none other than Attorney General William Barr, who expressed his pleasure that “[the] DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research.” Poetry it is not, but that doesn’t mean it isn’t remarkable.
On the contrary, this announcement serves as the death knell for a 50-year run of NIDA’s grow, monopolizing and serving as the only source of approved cannabis for researchers like Sisley.
In a conversation with Civilized that took place just days before the DEA’s announcement, Sisley described the quality of the product she’s received from NIDA as “a green powder full of stems, sticks, seeds, and leaves.” The onus behind the lawsuit has been to help researchers like herself secure a higher-quality study drug (read: cannabis) to ensure that study subjects can utilize "real life" pot, like what's found at dispensaries, rather than NIDA's inferior weed, which (obviously) comes with greatly reduced efficacy.
On Monday morning, Sisley declared the news “a complete victory for our [Washington, D.C.] circuit case,” though she says her optimism lessened substantially as she poured over the fine-print of the DEA’s announcement and spoke with former agency directors and policy experts.
“If we just look at today's announcement on its face,” Sisley noted in an email follow-up, “it looks very exciting and optimistic. If we hadn’t spent so many years battling the federal government, I would be more hopeful but I am nervous because I know their delay strategies.
Despite Sisley’s waning enthusiasm, Monday’s news still potentially represents a hard-fought victory for federal researchers tired of being forced to use inferior cannabis in their studies.
Sisley filed suit this spring over the DEA’s failure to process external cultivator applications to supplement the NIDA grow — something the agency announced and requested of its own volition in 2016 before going entirely radio silent. Despite the fact that the DEA solicited cannabis cultivation licensing applications three years ago (Sisley estimates that somewhere between 25 and 35 applications were submitted) exactly zero have been processed so far.
Though it’s a most welcome development to hear that the DEA plans to finally stop dragging its feet, Sisley worries that the inaction that’s led to this point has already caused an irreparable delay. Compared to where Canada — which federally legalized in 2018 — is today, it’s possible the U.S. may never recover the ground its ceded.
“We’re miles behind them,” Sisley confirms, “because they've always had multiple licenses for growers providing cannabis for research. Sadly, we're so far behind that we may never be able to catch up.”
Part of the reason for Sisley’s outlook is the time required to put a GMP (Good Manufacturing Practices) grow together. The FDA requires that all grows of this nature meet GMP to qualify as a provider of cannabis for federal research.
“Even if the DEA started licensing growers tomorrow, it's still going to take years for these folks to get up and running and prove they have a GMP-quality grow," Sisley explains. "It usually takes four or five growth cycles for them to be able to demonstrate GMP.”
In the interim, Canada — as well as government-approved research in Israel, the Czech Republic, Australia, and Columbia — continues to gain a competitive advantage over the U.S.
“If we could ever get there, we would see a renaissance of cannabis research and maybe we’d be able to actually demonstrate its efficacy as a medicine, because that hasn't been allowed," Sisley suggested last week. "So far, all we've been allowed to do is to research cannabis as a drug of abuse and look at its potentially harmful effects.”
Now, assuming the Department of Justice stays true to its word about ensuring that the DEA process grow applications, Sisley’s hope is finally poised to become a reality. Pending any revelations contained within the DEA’s plan, the most first domino in a long-awaited chain-reaction has finally fallen.
“We just need to keep the DEA’s feet to the fire, and make sure they follow their own timelines that they laid out in today’s public notice," her statement continues. "It’s going to take a long time to get access to newly cultivated cannabis material for research, but at least that door is now kicked open.”