Change in the Air: Liz Warren Leads Group of Senators Pushing for Big Change in Marijuana Research

They're calling on the DEA to consider the prospect of licensing private manufacturers of cannabis for research purposes. 

By Paul Armentano

For decades federal officials have largely stymied large-scale clinical trial research into marijuana’s therapeutic benefits. Now a coalition of United States Senators is saying it’s time for a change.

Eight Democrat senators, led by Massachusetts Sen. Elizabeth Warren, fired off a letter this month to representatives of the US Department of Health and Human Services, the Office of National Drug Control Policy and the US Drug Enforcement Administration demanding to know why the federal government is not doing more to facilitate medical cannabis science.

The letter, which the senators cc-ed to the head of the US National Institute on Drug Abuse and the Commissioner of the US Food and Drug Administration, states: “Currently, twenty-three states and the District of Columbia have passed laws allowing for medical marijuana use, and an additional fifteen states have laws specifically allowing access to cannabidiol (CBD). While the federal government has emphasized research on the potential harms associated with the use of marijuana, there is still very limited research on the potential health benefits of marijuana – despite the fact that millions of Americans are now eligible by state law to use the drug for medical purposes. … With the pool of medical marijuana users growing in the United States, we believe that federal agencies have both an opportunity and a responsibility to craft a sensible research and public health strategy that allows us to generate meaningful data and conclusions from this ongoing natural experiment.”

Specifically, the senators are asking federal health officials to conduct “large-scale clinical trials” involving patients residing in legal medical cannabis states. The senators also request that the feds to provide better support, including financial support, to “independent scientists” who are interested in studying the plant.

Under federal law, all clinical protocols involving cannabis must meet the approval of the FDA, DEA and the NIDA. Until recently, such trials also required the additional approval from the US Public Health Service, but that hurdle was removed by the administration last month. Moreover, all federally approved studies must utilize marijuana grown and provided by the US government’s lone, federally licensed provider, the University of Mississippi. Testifying before Congress in late June, NIDA director Nora Volkow acknowledged that this monopoly limits scientists’ access cannabis and hinders research. Her conclusion is similar to that of the DEA’s own administrative law judge Mary Ellen Bittner, who in 2007 ruled that licensing additional cannabis cultivators “would be in the public interest.” But in 2009 former DEA director Michele Leonhart set aside the ruling. The agency issued its final rejection  in 2011.

As a result, Senator Warren and her colleagues are calling on the DEA and other federal agencies to once again consider the prospect of licensing private manufacturers of cannabis for research purposes.

Their letter concludes: “Many states and localities are moving forward with policies that facilitate the availability of medical marijuana to a greater proportion of the population than ever before. All participants in this important debate will benefit from rigorous, scientific research into the impact of these policies on American public health. Relevant federal agencies must play a leadership role in coordinating and facilitating that research if we are to ensure that public policy in this area is supported by our best science. We look forward to your response on this matter … no later than August 31, 2015.”

Senators Booker (D-NJ), Boxer (D-CA), Gillibrand (D-NY), Markey (D-MA), Merkley (D-OR), Mikulski (D-MD), and Wyden (D-OR), co-signed the letter. Yet these Senators are not the only ones now publicly pushing for further research, Last week, Senators Diane Feinstien (D-CA) and Charles Grassley (R-IA) – two longtime opponents of marijuana a law reform – penned an op-ed in Time Magazine calling on the Feds to “break down barriers to medical marijuana research.”
Specifically, the senators called on regulators at the US Department of Justice and HHS to “definitively determine whether CBD has scientific and medical benefits, and if so the proper schedule for it.”

They added: “We need to cut red tape and streamline the licensing and regulatory processes so research can move ahead. In addition, we must also find ways to ensure that researchers have access to the quantity and quality of marijuana that they need. Finally, we need to look at expanding compassionate access programs where possible, to benefit as many children as possible.”

Yet, while lawmakers’ calls for additional research are welcome, it belies the fact that ample scientific evidence already exists – and has for some time -- to validate cannabis’ therapeutic utility and to support its removal from its schedule I classification.

Unlike modern pharmaceuticals, the marijuana plant possesses an extensive history of human use dating back thousands of years, thus providing society with ample empirical evidence as to its relative safety and efficacy. Moreover, cannabis and its compounds are among some of the most well studied biologically active substances of modern times. A search on PubMed, the repository for all peer-reviewed scientific papers, using the term “marijuana” yields more than 21,000 scientific papers referencing the plant and/or its constituents, nearly half of which have been published just within the past decade. While it is true that most of these studies do not fall into the category of gold-standard Phase III placebo-controlled clinical trials, hundreds of methodologically valid studies assessing cannabis’s safety, efficacy, and mechanism of action exist in the available literature.

For instance, there are well over 100 randomized controlled studies, involving thousands of subjects, evaluating the relative safety and therapeutic efficacy of either whole-plant cannabis or individual cannabinoids. A review of a recent series of clinical trials evaluating whole-plant cannabis, sponsored by the University of California, concluded, “Based on evidence currently available the Schedule I classification (for cannabis) is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”

Twenty-three states and Washington, DC now permit physicians to recommend marijuana therapy. Some of these state-sanctioned programs have now been in place for nearly two decades. So while more clinical study is welcome, it is not necessary in order to precipitate a change in federal law. We already know enough about cannabis, as well as the failures of cannabis prohibition, to allow people the option to consume a botanical product that is objectively safer than the litany of pharmaceutical drugs it could replace.