When the Drug Enforcement Administration (DEA) announced on August 11 that they would not reschedule marijuana, which would have been an acknowledgement of its medical benefits, they also announced a separate policy change that would increase the number of federally registered marijuana manufacturers in order to foster more “scientifically meritorious” research.
Many marijuana advocates took this as a sign of progress. For decades, the DEA has promoted a monopoly on research-grade marijuana for use in federally-approved studies. There are over 350 registered research projects and all of them receive their marijuana from the University of Mississippi.
The DEA’s rationale for the severe restriction on supply owes to federal obligations to uphold both international treaty and the United States’ own law, the Controlled Substances Act, both of which severely restrict access to marijuana.
But with only one source of research grade marijuana, it is effectively impossible for scientists to put it through clinical trials that could confirm or deny its current classification, relegating cannabis to a sort of purgatory in between demonization and legalization.
Under the monopoly, there have been many concerns with the quality of the marijuana supply, including a lack of diversity of strains and potency, a lack of meaningful cannabinoid profiles and inconsistent samples, all of which call the integrity of the research into question.
“Obviously there is tons of other research out there, but if the marijuana they are using isn’t from the University of Mississippi, the Federal Drug Administration (FDA) won’t recognize it as valid because of the DEA’s restrictions,” says Michael Collins of the Drug Policy Alliance (DPA), a drug policy reform nonprofit in New York. “It’s a vicious cycle.”
But even Collins recognizes the increase in federally registered research manufacturers as a significant step for the DEA — at least a recognition of 40 years of circular logic, if not a more meaningful sign of progress.
Collins applauds the change as a big step forward in interdepartmental collaboration. For the first time in a decades-long stalemate, the DEA is working with the National Institute on Drug Use to redetermine the legitimacy of marijuana as medicine in the eyes of the FDA.
In Colorado, considerably more progress is being made. Two years ago the state legislature seized the opportunity to generate research that could provide scientific evidence of cannabis’s medical benefits, if not at the federal level, then at least in the eyes of the state, which has had a medical market for 16 years.
With an unexpected surplus in revenue collected from medical marijuana patient registration fees, state officials funded the Medical Marijuana Research Grant Program (MMRGP) that currently supports nine research projects, three of which purchase and administer marijuana from the University of Mississippi with strict oversight from the DEA.
MMRGP manager Ken Gershman of the Colorado Department of Public Health and Environment says Colorado’s program will not be affected by the DEA’s recent decision and expressed skepticism it would have much of an affect at all.
“For now it is just a piece of paper with a new policy on it and how or when it will be operationalized is yet to be seen,” he says. “The DEA being the DEA, they are not in a hurry to do anything, so I wouldn’t say they they have changed sides just yet. There is a lot to be seen about how much of this is good faith and how much is real effort.”
Gershman points out that the requirements to qualify for a DEA permit are onerous, both fiscally and operationally, and adds that any applicant that has previously been out of compliance with federal law is not eligible to apply. This means that potential applicants would be starting from scratch, both in terms of know-how and property and equipment.
“The timeline could be ridiculously long here,” Gershman says. “So is this progress? To be seen. To be determined.”
The DEA has yet to recieve a single application since it opened for submissions. In the meantime the realities of marijuana research remain relatively unchanged, frustrating many clinical researchers working with cannabis in the U.S.
University of Colorado professor Nolan Kane, who led the Cannabis Genomic Research Initiative, one of the deepest scientific explorations of the cannabis genome ever performed, has difficulty seeing progress.
“Depending on the details, it may be that there are in reality just as many barriers to research as there were previously,” he writes in an email. “It may be that these supposed changes are really not any different than how things were previously … It is not clear to me that this decision will affect our ability to work with any of the material that people outside of the university are using.
While it’s possible the DEA is changing and seeking to create an opportunity for more and better research on marijuana, it is also possible that this is nothing more than a waving of the hand designed to distract the public from the underlying stalemate.
To be seen. To be determined.
This opinion column does not necessarily reflect the views of Boulder Weekly.
