A new paper published by the National Cancer Institute (NCI) takes a critical look at the cannabis regulatory systems in the United States, writing that much-needed scientific investigation into the drug’s potential safety concerns and health applications is being stifled by administrative burdens.
Research and scientific awareness is not able to keep pace with how cannabis products are being made and used, due to barriers from the federal Controlled Substances Act (CSA). Adding to the bureaucratic red tape is the requirement that all approved research projects obtain cannabis through NIDA.
The article, “Challenges for Clinical Cannabis and Cannabinoid Research in the United States,” is part of a series of papers that came out of an online symposium organized by the NCI last year that focused on the state of science surrounding cannabinoids and cancer. The paper is written by a research team of six including authors from federal agencies such as the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) and Food and Drug Administration (FDA).
“In an effort to elucidate both the safety and the potential therapeutic uses of these products for a range of indications for which they are already approved in an overwhelming majority of the United States,” they wrote, “researchers must work tirelessly through institutional, regulatory, funding, and drug supply hurdles, all of which significantly influence the scientific impact, public health relevance, and efficiency of investigations.”
A nine-paper collection of articles came out of the symposium, including writings on cancer risks and nonmedical cannabis use, cannabis policy and public health, using cannabinoids to treat adverse effects of cancer or chemotherapy and cannabinoids’ possible role in cancer treatment and prevention.
“The administrative challenges for cannabinoid research include the single domestic source requirement for cannabis, complex and lengthy registration processes, and schedule I classification of nonintoxicating cannabis components such as CBD,” the paper on research says. Due to the time, expense, and regulatory knowledge required to get a single study started in this field, researchers frequently opt not to pursue work in this area. Although more issues around cannabis use need to be addressed by diverse experts, the field will likely continue to be limited to those institutions and researchers who have historically pursued this work.
Published this month in the Journal of the NCI Monographs, the article concludes: “Conflicting federal and state cannabis regulations hinder research in several ways including the inability of researchers to access products that are legal in their state, a lack of standardization and quality control of cannabis and cannabis-derived products within and across states, and no national oversight of this standardization and quality control or the industry.”
The lack of scientific knowledge of cannabis could have a potential impact on consumers and patients. The long-term effects of high-THC or regular CBD use are not well known and doctors often move away from recommending cannabis to patients even in cases where it might be beneficial.
“Oncologists frequently discuss the clinical use of cannabis with their patients although most feel they lack an adequate knowledge base to advise effectively,” the article says.
Despite strong evidence in support of the use of cannabinoids for chemotherapy-induced nausea and vomiting as well as pain, many oncologists prefer to recommend approved pharmaceuticals with larger bodies of supporting evidence.
With most states having legalized marijuana in some form, an array of new and relatively unstudied products has appeared on consumer and medical markets. The authors believe that, with the widespread availability of novel cannabis and cannabinoid products, there is an “urgent need to understand their safety and potential effectiveness for medical indications.”
The article’s authors advocate collaborations between more experienced researchers and those less familiar with cannabis. “Universities and agencies like the FDA can also provide guidance and support. International partnerships could have significant potential to enhance research collaboration by leveraging opportunities in other countries and potentially avoiding difficult regulations that hinder development.”
The federal legalization of hemp and hemp-derived CBD via the 2018 Farm Bill has added to the confusion, the authors say. The FDA retained the right to regulate products containing cannabis, including enforcement action. This encompassed jail time and hefty legal fees against businesses making unsanctioned claims about the therapeutic potential of cannabidiol (CBD) products, including those derived from hemp, or any attempt to introduce these products into interstate commerce.
While there has been movement in the field to relax regulations, including the landmark change decontrolling CBD derived from hemp, many changes have in fact made the regulatory landscape more confusing and difficult to navigate for the researcher. For instance, the federal government’s confusing scheduling of cannabinoids requires mastery to successfully identify whether a proposed trial with a potential study medication requires a schedule I DEA license. Based on the source of production and the formulation, Delta-9 THC, the main psychoactive component of cannabis, has 3 distinct schedules.
Efforts to expand research into cannabis and other Schedule I drugs, such as certain psychedelics, are gearing up. DEA and NIDA both testified at a House Energy and Commerce subcommittee hearing in favor of a White House proposal to streamline the process. To aid in the development of new federally approved therapeutic medications, the DEA has repeatedly proposed significant increases in the production of marijuana, psilocybin and other psychedelics for research purposes.
“It is critical that the scientific and medical community study Schedule I substances, as some may turn out to have therapeutic value,” DEA Principal Deputy Administrator Louis Milione said. “DEA supports the administration’s legislative proposal’s expansion of access to Schedule I research.”
In a separate report to Congress in October 2021, NIDA emphasized that the Schedule I status of controlled substances such as marijuana is preventing or otherwise discouraging research into their potential risks and benefits. But there is some movement in the fight to modernize marijuana research. President Joe Biden's infrastructure bill includes provisions aimed at allowing researchers to study the actual cannabis that consumers are purchasing from state-legal dispensaries instead of having to use only government-grown cannabis.
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