On October 6, 2022, President Joe Biden announced pardons for people convicted to marijuana use and possession under federal law. He also announced that he was directing his administration to review marijuana’s listing as a Schedule I drug under the Controlled Substances Act, which is defined as one with a high potential for abuse, no currently accepted medical treatment use, and lack of accepted safety for use under medical supervision.
The press coverage has focused on the pardons, but removing marijuana (cannabis) from Schedule I promises to have major benefits by making it possible to conduct research on cannabis that will better inform users, the public, public policy makers and regulators about the actual benefits and risks of cannabis use, particularly medical cannabis.
Cannabis’ Schedule I classification makes it very difficult to conduct medical and scientific research to inform the public, health professionals, policymaking and regulation. The fact that cannabis (except hemp containing CBD) remains on Schedule I means that performing research requires specific approvals from the US Drug Enforcement Administration which are extremely difficult and time-consuming to obtain and can take years. In addition, research is only permitted on cannabis grown at one farm in Mississippi and by Biopharmaceutical Research Company in California, which has somewhat much more flexible conditions than U Miss. It is illegal for researchers to purchase or analyze dispensary or other products that are widely available. These products are of greater diversity in content and formulation than what is available through these two DEA-approved suppliers.
Under the Safe and Drug Free Schools Act, the sanction for universities violating these procedures could include termination of all federal funding. NIDA Director Nora D. Volkow testified before the House Committee on Appropriations in 2019 that, “indeed the moment that a drug gets a Schedule I, which is done in order to protect the public so they don’t get exposed to it, it makes research much harder, and this is because you actually have to go through a registration process, that is actually lengthy and cumbersome, but also, it restricts the source where you can get the particular drug that you are interested in investigating, and this is something that we worked with cannabis, is a perfect example or marijuana…”
While it is clear that there are some medical uses for cannabis, these uses remain poorly defined and important details that are important for defining medical uses of drugs, including specific classes of patients who would benefit, appropriate dosages, and accompanying risks are largely undefined. Answering these questions — and creating an appropriate regulatory structure at the FDA — require animal and human experiments and, eventually, clinical trials that are almost impossible to conduct because cannabis remains on Schedule I.
The resulting information vacuum allows a wide range of unsubstantiated “medical” benefits to be claimed for cannabis without meaningful proof that these claims are justified. (Once upon a time, nicotine was promoted as a medicine for a wide range of maladies.) In addition, the need for “patients” to take their cannabis “medicine” has been used to argue against sensible restrictions on public use to protect bystanders from secondhand exposure. Better defining actual medical uses of cannabis will define who, how, when and for what conditions cannabis has a medical benefit.
Rapid commercialization is outpacing state and federal regulatory rulemaking, with myriad permutations of novel and traditional cannabis products quickly becoming available to the public in spite of cannabis’ Schedule I status. This situation became acutely evident in the face of the widespread appearance of EVALI, the severe lung disease in (mostly) youth and young adults vaping THC, nicotine, and both products that was identified in 2019. Despite the serious lung disease (and deaths) it was practically impossible to study the cannabis vaping devices that people were actually using because THC remains on Schedule I.
Descheduling cannabis would allow research to be performed more efficiently and on a wider array of cannabis products that are actually on the market, so that claims regarding risks and benefits could be fully vetted by the scientific community, the FDA, and the states. Research is particularly needed to assess therapeutic claims made for “medical” cannabis to allow public health authorities, regulators, policy makers to make evidence-based policy and health professionals to respond to questions from their patients and their families regarding cannabis.
(This post is edited and updated from Bowling CM, Hafez AY, Glantz SA. Public Health and Medicine’s Need to Respond to Cannabis Commercialization in the United States: A Commentary. J Psychoactive Drugs. 2020 Sep-Oct;52(4):377-382. doi: 10.1080/02791072.2020.1761040. Epub 2020 May 19. PMID: 32429772; PMCID: PMC7674246. The full paper also discusses corporate entry — including by Big Tobacco — into the cannabis market. It is available for free herehttps://pubmed.ncbi.nlm.nih.gov/32429772/.)
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