DEA’s lack of action to license marijuana growers threatens next phase of PTSD study
By NIKKI WENTLING | STARS AND STRIPES Published: August 3, 2018
WASHINGTON – In the final months of Barack Obama’s presidency, the Drug Enforcement Agency announced it would license more growers to produce marijuana for scientific research – a decision that was meant to facilitate research into the drug.
Nearly two years later, federal authorities haven’t approved or denied any applications. The lack of action has the potential to thwart the next step in a first-of-its-kind study into marijuana’s effects on veterans with post-traumatic stress disorder, researchers said.
“Until the DEA licenses other growers for research, we’ll continue to be stuck in limbo, not able to do what the medical community has been demanding,” said Sue Sisley, the principle investigator for the study.
Sisley, along with the Multidisciplinary Association for Psychedelic Studies, struggled for years to gain federal approvals to launch the study, which tests different potencies of marijuana on veterans. It’s now been underway for more than a year, and this week Sisley enrolled the 70th participant of the 76 veterans it requires.
The study, based at the Scottsdale Research Institute in Phoenix, is on track to enter its next phase in spring 2019, at which point it will need a new marijuana supplier.
The National Institute on Drug Abuse – the only federally approved source for marijuana – is providing marijuana for the study now. However, NIDA, a government research institute, is allowed only to provide marijuana for academic research, not commercial sales, which would be necessary for the next phase of the study, said Brad Burge, communications director for MAPS.
The U.S. Food and Drug Administration requires Phase 3 trials to be conducted with the same product that would be commercially available if the trials proved marijuana safely and effectively treated PTSD.
“Until the NIDA monopoly ends, no domestically approved marijuana can ever be made into an FDA-approved medicine,” Burge wrote in an email.
Moreover, Sisley said the quality of marijuana provided by the National Institute on Drug Abuse so far has been of a lower quality than desired.
“There really is no study drug for Phase 3, bottom line,” she said.
When the DEA began accepting applications for more growers, the Scottsdale Research Institute and MAPS applied. Neither has heard a response to their application.
Now, about one week away from the two-year mark of the DEA’s decision, the researchers are preparing to fight.
“Two years is way too long,” Burge said.
Eight senators, comprised of five Democrats and three Republicans, sent a letter to Attorney General Jeff Sessions last week, urging the DEA to finish reviewing the applications. The senators wrote they knew at least 26 applications for licenses had been submitted.
“Our nation’s need for meaningful, federally sanctioned research is critical,” they wrote. “Research and medical communities should have access to research-grade materials to answer questions around marijuana’s efficacy and potential impacts, both positive and adverse. Finalizing the review of applications for marijuana manufacturing will assist in doing just that.”
The senators asked Sessions to explain what the Justice Department has done to review the applications and to provide a time estimate for rejecting or approving them. They asked to have answers by Aug. 10.
On Aug. 11, it will have officially been two years since the DEA announced it intended to license more growers.
The senators who signed the letter are: Sens. Brian Schatz, D-Hawaii.; Chuck Grassley, R-Iowa.; Corey Gardner, R-Colo.; Kirsten Gillibrand, D-N.Y.; Amy Klobuchar, D-Minn.; Christopher Coons, D-Del.; Orrin Hatch, R-Utah., and Tim Kaine, D-Va.
The Justice Department did not respond to a request for comment.