The federal government must stop stifling medical marijuana research

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In June, for the first time, The Food and Drug Administration  approved a plant-derived medicine from marijuana. The prescription drug, known as Epidiolex, contains a proprietary formulation of cannabis’ organic compounds — primarily cannabidiol (CBD) —for the treatment of severe seizure disorders.

The British pharmaceutical company — the manufacturer of the drug — a has long been licensed by the U.K. government to privately grow strains of cannabis for the purpose of drug development.

{mosads}But no such avenue currently exists for marijuana-based drug development in the United States. That is because, unlike in Great Britain (and in various other countries, like Canada and Israel), neither privately grown cannabis nor products derived from privately grown cannabis may be administered to subjects in the course of an FDA-approved clinical trial. This also includes those manufactured by state-licensed and compliant manufacturers

Instead, investigators must obtain whole-plant cannabis from a single source: The University of Mississippi, which since 1968 has held the only federal licensed to cultivate cannabis for research purposes.

But, even today, the variety of products offered via the U-Miss supply chain is exceedingly limited and, far too often, of poor quality. According to its current menu, only six distinct strains of cannabis are available to researchers.

These strains range from between zero percent THC to 6.7 percent THC, far below the average potency of available products in legal states or on the black market. Furthermore, none of the available products contain even close to one percent CBD – a therapeutic compound of growing interest to scientists.

Moreover, U-Miss’ “research-grade” marijuana is only available in rolled cigarettes. Want to assess the safety and efficacy of cannabis-infused edibles or tinctures? Sorry, no such products are currently available. Want to engage in large-scale Phase III trials assessing the efficacy of marijuana for the purpose of one-day bringing a plant-derived product to market? Sorry, that is not permitted under the present system either.

Think this monopolistic policy makes little sense? You’re not alone. In fact, during a congressional testimony in 2014 the director of the U.S. National Institute on Drug Abuse, which oversees the U-Miss program, acknowledged that cannabis is the only controlled substance that the federal government has exclusive research control over. Indeed, under current regulations, private producers may be licensed to manufacture other schedule I substances — like MDMA — but such activities are not permitted for marijuana.

On Wednesday, members of Congress for the first time took action to undo this unduly restrictive and irrational policy. Members of the House Judiciary Committee voted in favor of legislation (HR 6534: The Medical Cannabis Research Act of 2018) to facilitate federally-approved clinical trials assessing the efficacy of whole-plant cannabis by mandating the government begin the process of licensing private marijuana growers. The vote marks the first time that lawmakers have ever decided in favor of easing existing federal restrictions which limit investigators ability to clinically study marijuana in a manner similar to other controlled substances.

Specifically, H.R. 6534, sponsored by Rep. Matt Gaetz (R-Fla.) and 40 cosponsors, mandates the U.S. Attorney General to take action on some 25 pending federal applications from private entities seeking to grow cannabis for research purposes, and to approve at least two additional marijuana manufacturers within a year.

In August of 2016, the U.S. Drug Enforcement Administration (DEA) publicly called for additional applicants, but since then neither the DEA nor the Department of Justice has taken any steps to either affirm or deny these requests. In fact, in May DEA Administrator Robert Patterson even appeared to walk back the DEA’s request by testifying that such licensing may be prohibited by international drug treaty obligations. Of course, being a signatory to such treaties hasn’t been an impediment to licensed marijuana production and drug development elsewhere, and such concerns should not be interpreted as legitimate barriers to reform here.

Representative Gaetz is correct in his opinion that federal hurdles to clinical cannabis research are unduly onerous and ought to be abolished. They are artifacts of a bygone era when the US government was swept up in the hysteria of “reefer madness.”

But today the science surrounding cannabis, and America’s understanding of and relationship with the plant, has changed dramatically. Congress must act to better facilitate and fund efforts to better explore cannabis’ therapeutic applications and impact on health, and passage of H.R. 6534 is a significant and necessary first step in this direction.

Paul Armentano is the deputy director of the National Organization for the Reform of Marijuana Laws. He is the co-author of the book, Marijuana Is Safer: So Why Are We Driving People to Drink? and the author of the book, The Citizen’s Guide to State-By-State Marijuana Laws.

Tags Matt Gaetz medical marijuana weed

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