The American Psychological Association (APA) called on the Department of Justice to evaluate the more than two dozen applications for research cannabis cultivation that have gone unanswered since 2017.
APA President Arthur C. Evans Jr., Ph.D., penned the letter directly to U.S. Attorney General William Barr in which he noted there was “no longer any doubt that at least some of the chemical constituents of cannabis have therapeutic benefit.”
The Washington, D.C.-based APA, a scientific and professional organization, represents nearly 118,400 researchers, educators, clinicians, consultants, and students.
“The scientific community is eager to advance cannabis research on both the harmful and therapeutic effects of cannabis and its derivatives,” Evans wrote. “Without access to an expanded range of cannabis products engineered under FDA-approved Good Manufacturing Practices, scientific research cannot hope to keep pace with the ever-expanding recreational and medicinal cannabis marketplace.”
Proper Research Cannabis is Essential
The need for a broader supply of cannabis research products is essential to the many areas of research currently underway and for future projects, says Dr. Marcel Bonn-Miller, coordinating principal investigator for the first-ever randomized controlled trial of whole plant marijuana as a treatment for post-traumatic stress disorder (PTSD).
The trial was recently completed in sponsorship with the Multidisciplinary Association for Psychedelic Studies (MAPS) in February 2019.
“As researchers begin to look at the many conditions and illnesses that may be positively impacted by cannabis, from Alzheimer's to ALS to cancer to sleep problems, you name it, we need access to pharmaceutical-grade cannabis/cannabinoids,” Bonn-Miller said.
A Limited Supply of Research Cannabis
Although there is an open solicitation process through NIDA, Mississippi — popularly known as Ole Miss — is the only university that has been awarded this contract for the past five decades.
But things are changing, ever so slightly. In August 2016, the DEA announced it will allow additional growers to register with them to produce and distribute marijuana for research purposes.
By August 2018, Louisiana State University's Agricultural Center along with GB Sciences Inc. produced their first research cannabis plants through a through a tissue culture propagation to ensure genetic consistency. Researchers welcome the idea of new sources. Cannabis from Ole Miss isn't always up to par, they have complained over the years.
Dr. Sue Sisley, a primary care physician in Scottsdale, Arizona, is the principal investigator on the MAPS study on PTSD that took four years and the cooperation of 76 U.S. military veterans to complete.
Sisley told PBS News in 2017 that she waited 20 months for government-research cannabis from the University of Mississippi. When it arrived, she said, it resembled green talcum powder rather than cannabis. Sisley will be leading a presentation on this topic from 11 am. to noon March 14, 2019, at the upcoming South by Southwest (SXSW) festival in Austin.
What are researchers doing as they wait for the logjam to clear up?
“In addition to the University of Mississippi, there are two other sources of cannabis and cannabinoids for research purposes: imported plant-derived cannabis or extracts from companies in Canada, the United Kingdom, or Germany; and synthetic cannabinoid formulations produced by companies like Insys or Zynerba,” said Bonn-Miller, an adjunct assistant professor at the University of Pennsylvania Perelman School of Medicine in Philadelphia. Alternative sources have their limitations, too, Bonn-Miller pointed out.
“Unless one is researching certain hemp-derived formulations or Epidiolex, cannabinoid research requires strict Drug Enforcement Agency (DEA) oversight given its Schedule I status,” Bonn-Miller said. “That said, all research on cannabis/cannabinoids, regardless of source, requires oversight and approvals by the FDA as well as local institutional review boards.”
No matter where the cannabis comes from, Bonn-Miller continued, the Drug Enforcement Agency (DEA) needs to be involved.
“It's a pain regardless of where you're getting it,” he said. “But now with the Farm Bill, hemp is unscheduled. And though some things have changed, one needs to still deal with the DEA when working in the cannabis research space.”
Kim Mills, senior Communications adviser for the Executive Office of the APA, found similar issues.
“Many psychologists were expressing concern that the limited range of research-grade cannabis products was inhibiting research and the scientific community was frustrated by the DoJ's apparent inaction on the grower applications,” Mills said.
While many psychologists are currently studying various treatments for cannabis use disorder, Mills said, she pointed to a report from the National Academy of Sciences, Engineering, and Medicine in January 2017 that suggested more research is needed to determine whether cannabis derivatives are effective on a variety of conditions of interest to psychologists, including sleep disturbances, various pain conditions, and certain types of motor disorders.
“Psychologists are also interested in how cannabis use interacts with the treatment of other co-occurring conditions, including PTSD, anxiety/depression, and other substance use disorders, such as alcohol use disorder and tobacco/nicotine dependence,” Mills said.
What's the Holdup?
As dozens of applications for cannabis cultivation licenses sat unattended under former U.S. Attorney General Jeff Sessions, the appointment of William Barr as attorney general inspired a small sigh of relief among cannabis advocates at the end of January 2019 when Barr said he did not intend to go after “parties who have complied with state law in reliance on the Cole Memorandum.”
Barr was referring to the Obama-era memo meant to prevent federal prosecutors from going after state-legal cannabis operations. Jeff Sessions had rescinded the memo in January 2018.
Any response to the APA's letter to Barr?
“None yet,” Mills said. But they're waiting and hoping.
“We look forward to the day that a carefully regulated class of cannabis products with known composition, representing the full range of isolated cannabinoid compounds, and commercially available routes of administration become available for scientific study,” Mills said.
Bonn-Miller was equally, if cautiously, optimistic.
“Cannabis research is not at all impossible, you just have to jump through extra hoops, which slows things down,” he said. “They're not barriers though, they're hoops.”