Those who work in marijuana policy reform have long been aware that federal regulations and agencies significantly impede investigators’ ability to conduct clinical studies of cannabis, in particular those protocols designed to evaluate the plant’s therapeutic potential. During recent testimony on Capitol Hill, Nora Volkow, the director of the US National Institute on Drug Abuse, admitted this fact publicly to members of Congress. (View the entire June 20 hearing, titled “Mixed Signals: the Administration’s Policy on Marijuana, Part Four,” here.)
Though Volkow appeared Friday before the House Committee on Oversight & Government Reform ostensibly to speak about her recent review in the New England Journal of Medicine (a paper I previously critiqued for AlterNet here), she spent a significant portion of her time defending her agency’s virtual stranglehold on investigators’ ability to engage in cannabis-specific clinical research.
Under federal law, all clinical protocols involving the ingestion of plant cannabis by human subjects must use cannabis grown at the University of Mississippi and provided exclusively by the federal government via NIDA. Similar clinical research restrictions do not presently exist for any other drug, including other schedule I controlled substances such as heroin and LSD, both of which may be obtained by clinical investigators from privately funded, federally licensed manufacturers. So acknowledged Volkow in the following exchange with Virginia Democrat Gerry Connolly:
Rep. Connolly: “Right now, NIDA has a monopoly on the production of marijuana to be used for FDA-approved research and medical purposes and that’s been the case since 1974. Is that correct?”
Nora Volkow: “That is my understanding.”
Rep. Connolly: “Is there any other schedule I drug used for research purposes that’s available only from one government source?”
Nora Volkow: “I don’t think there is.”
Rep. Connolly: “So, again, (this is) unique to marijuana. You [NIDA] have exclusive control for research purposes unlike any substance.”
Nora Volkow: “Correct, in the United States.”
Rep. Connolly: “What is the rationale for that?”
Nora Volkow: [long pause] “I guess the rationale … is that you want to be able to have control over the material that you’re providing for research.”
Rep. Connolly: “Why wouldn’t that be true about cocaine?”
Nora Volkow: “Cocaine is a drug that is regulated differently. …The production of marijuana is based on plants.”
Rep. Connolly: “DEA has licensed privately funded manufacturers to produce methamphetamines, LSD, MDMA, heroin, cocaine, and a host of other controlled substances for research purposes. Is that not correct?”
Nora Volkow: “For research purposes, yes.”
Further, in order for clinical investigators to access NIDA’s limited pot supply, researchers must first obtain permission from multiple agencies, including the US Food and Drug Administration, the US Public Health Service (a division of the Department of Health and Human Services), NIDA, and the Drug Enforcement Administration. Yet federal approval of all of these multiple agencies is not a necessary requirement for researchers seeking to clinically investigate any substance besides cannabis.
Rep. Connolly: “Human studies of schedule I drugs have to be approved by the FDA. Is that not correct?
FDA Regulatory Programs Deputy Director Doug Throckmorton: “That’s correct.”
Rep. Connolly: “But (in) studies involving marijuana, additional approval also has to be sought from NIDA and HHS. Is that not correct?
Nora Volkow: [inaudible]
Rep. Connolly: “Is that true about heroin, cocaine, and methamphetamines? Do they have to go through that triple-tier approval process for research as well for human studies?”
Nora Volkow: “No. The approval for those human studies mostly comes from review committees at the NIH and if the DEA approves of giving them the drug (then) it’s a simple, it’s a different process.”
Rep. Connolly: “Yes, it’s a different process and it’s less cumbersome.… And we’ve created all kind of special barriers with respect to marijuana as if it was the über alles of all drug abuse when, in fact, it is not. And we’ve impeded the ability to have legitimate research that could benefit human health. And it’s very hard for me, frankly, to understand why we continue to insist it is a class I substance.”
Nonetheless, even despite the onerous restrictions placed upon cannabis research in the United States, limited numbers of clinical trials assessing the safety and efficacy of marijuana as a medicine have been conducted and their findings appear in the scientific literature. A recent review of a series of California state-sponsored, FDA-approved, placebo-controlled clinical trials assessing the efficacy of plant cannabis in subjects with multiple sclerosis, HIV, neuropathy and other diseases affirmed: “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that information on safety is lacking.”
Yet, it is self-evident that a far greater body of literature would exist in regard to cannabis’ therapeutic efficacy if this research was not reliant on partnerships with federal agencies such as the DEA, which categorically opposes any acknowledgment that marijuana possesses therapeutic utility, or NIDA, whose spokesperson once acknowledged to the New York Times, “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use…. We generally do not fund research focused on the potential beneficial medical effects of marijuana.”
Notably, even NIDA’s director appeared to concede this latter fact at the close of Friday’s hearing.
Rep. Connolly: “We both agree that rigorous scientific research ought to occur here. It should occur in an unbiased fashion. (But) marijuana is not treated like any other substance. In fact, cocaine is more liberally treated for research purposes than is marijuana. … Marijuana is the only drug that NIDA has exclusive research control over.”
Nora Volkow: “Just to clarify, definitely we do a lot of research as it relates to cannabinoids and we speak about marijuana but marijuana is a series of chemicals, many cannabinoids, and what we are interested in is extracting the active ingredients.”
Rep. Connolly: “The mission of your agency is drug abuse. It’s not medical research into the possible efficacy of derivatives from otherwise dangerous or semi-dangerous drugs. And given the fact that you have a monopoly over the control of marijuana for research purposes…a reasonable inference could be drawn that you are less than motivated as an agency to assist us in that rigorous medical research.…Your mission is not the same as that of those wishing to pursue medical research as to the beneficial effects. Your own testimony never mentioned beneficial effects or the potentiality of it.”
Nora Volkow: “You are absolutely right. We are the Institute of Drug Abuse and you are absolutely right.”
So, now that Congress is aware of the problem, the bigger question remains: What, if anything, are they going to do about it?
Paul Armentano is the deputy director of NORML (National Organization for the Reform of Marijuana Laws) and the co-author of Marijuana Is Safer: So Why Are We Driving People to Drink (Chelsea Green, 2009).
