Scottsdale Research Institute has a proposal for the U.S. Drug Enforcement Administration: Use the agency’s authority to accelerate access to good-quality cannabis for medical research.
“It can just waive” certain rules if the move has public health benefits, institute attorney Shane Pennington said. “It’s hard to imagine why they wouldn’t.”
Located in Arizona, the institute conducts clinical trials and research on plant products, including marijuana. The institute’s founder, psychiatrist Dr. Suzanne Sisley, has long sought to study whether cannabis helps veterans with PTSD and related conditions. She founded the institute to study marijuana’s potential benefits.
Pennington pointed to oft-repeated calls from both political parties and various parts of government on the need for more cannabis research. “So why are we stalling?” he asked.
In March, DEA published a proposed rulemaking—“Controls to Enhance the Cultivation of Marihuana for Research in the United States”—in the Federal Register. It involves who can grow cannabis in bulk for research purposes.
For about 50 years, the University of Mississippi has had the only federally sanctioned facility for growing marijuana, supplied through a contract from the NIH’s National Institute on Drug Abuse. Researchers have long complained that the supply is poor quality and doesn’t reflect what consumers actually use, resulting in useless research.
With its new proposal, DEA purports to expand the number of registered growers and advance research. It would also make the agency, chartered to fight drug crime, the central body allocating marijuana for research purposes.
Along with hundreds of others, the Scottsdale Institute responded with comments.
In 2016, at the tail end of the Obama Administration, DEA invited research organizations to request a growing permit. The institute and more than 30 other entities applied.
For the next three years, DEA sat on the applications. Last year, the Scottsdale Institute sued to force the agency to act on its application. In summer 2019, DEA responded that it would propose new rules on the registration process and did so with the March proposal.
Hundreds of comments on that proposal have since come in. Many parties praised movement on the issue and some supported the proposal in general. But some organizations expressed concern that it would still delay research more than necessary.
The agency’s proposal mentions that the Department of Justice determined that the agency’s 2016 policy change violated the U.S. Controlled Substances Act and United Nations’ Single Convention on Narcotic Drugs. In its comment, the institute pointed out that the proposal does not include the legal basis for that conclusion, which federal rules require.
A Secret Memo
Rumors had swirled that the Office of Legal Counsel that advises the executive branch had been reviewing the 2016 policy statement during the three year delay. That OLC opinion was not publicly disclosed, however.
The institute sued DOJ and DEA again earlier this year, calling for the OLC opinion—with its reinterpretation of those laws—under the Freedom of Information Act. The parties settled and the 2018 OLC opinion became public last month.
It found that the DEA must change the policy it announced in 2016 in order to comply with the U.N. treaty. Instead, it said the DEA would have to monopolize the allocation and distribution of cannabis grown for research purposes.
The institute disagrees.
“DEA claims it supports marijuana research but can’t register any additional marijuana growers until it completes this rulemaking process. It’s not clear why DEA believes its hands are tied in this way,” the institute said. Essentially, it argued DEA has authority to accelerate the process without its new proposal.
Last week, the institute sued DEA again, asking the U.S. Court of Appeals for the Ninth Circuit to review cannabis’ schedule 1 status, among other issues. Besides the institute, petitioners in the case include military veterans who say they could have avoided years of pain and suffering if they had easier access to marijuana.
Vets, researchers agree
The nonprofit Veterans Cannabis Project also commented on the DEA proposal. The group argues the lack of federally-compliant, genetically diverse cannabis, and the existence of only one approved cultivator, block meaningful research.
DEA’s nearly four-year delay in implementing its grower program “gives significant cause for concern and skepticism,” the group said. “The DEA’s reticence and inertia surrounding cannabis research inspire a loss of credibility in the organization in the eyes of our membership.”
“We find it deeply upsetting that the DOJ and DEA institutionally would not take every opportunity to enable American companies and researchers to examine how cannabis could help treat wartime wounds,” the group stated.
The University of California system—with 10 research campuses and six medical schools—also commented. It called for allowing universities to conduct research with cannabis products legally available in states.
“The fact of the matter is that there are more questions than answers about the safety, benefits, and risks associated with marijuana use,” UC stated. These include questions over cannabis’ role in reducing or exacerbating opioid-related problems; detecting cannabis intoxication in drivers; impacts of high-THC-content products on adolescents and pregnant women.
“The recent outbreak of severe lung disease in young people using e-cigarettes [including cannabis vapes], is extremely frightening yet the issue cannot be effectively studied,” UC said. “The urgency…cannot be overstated.”
It called the inability to study cannabis “a detriment of the public’s capacity to make informed decisions, the economy of our country, and most importantly, the health of our citizens.”
In its comments, New York-based cannabis company Columbia Care complains, “relying on cannabis grown at a single academic location in the United States greatly hampers clinical research” into cannabis.
“This system imposed by the DEA is seemingly at odds with expressed desires from other federal partners,” Columbia Care said.
The American Psychological Association and the College on Problems of Drug Dependence argue that making a wider range of cannabis products available for research is only part of the solution. The groups stressed a need for more cannabis scientists, and to reevaluate DEA’s role in overseeing it—specifically, the security requirements imposed on scientists.
Cannabis nonprofit Americans for Safe Access called for creating a new agency—the Office of Medical Cannabis Control—to oversee research program requirements and to set standards. This would potentially allow state-licensed cultivators to provide researchers with high quality cannabis. Unlike DEA, Safe Access noted, the proposed agency would have no history of prosecuting the activities DEA seeks to oversee.
Comments from Ross Gardiner of California cannabis product manufacturer Ciencia Labs argue scientists should be able to acquire cannabis from licensed state retailers. The cannabis from the University of Mississippi “is completely inconsistent with the cannabis being consumed across the U.S.,” Gardiner stated.
Darla Landfair of Canopy Growth USA argues researchers need the ability to procure cannabis from any state legal dispensary to reduce costs, start studies more easily and better represent what consumers use.
Charlie Stivers, founder of Phytorite Marketplace, a provider of hemp products, called for rescheduling cannabis and allowing institutions to research the plant and its medicinal benefits. “We’re far lagging Israel and Canada in these efforts to save lives and give alternatives,” he said.
The DEA has started reviewing comments, but said it did not have a timeline on when it could issue a final rule.
“DEA is committed to working expeditiously to finalize the regulations and register additional growers consistent with these regulations,” DOJ spokesman Michael Miller said in an email.