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A top federal health official says marijuana research is “fraught with hurdles”—including its continued prohibition under federal law—that need to be addressed in order to unlock studies on areas such as how cannabinoids can serve as “safer tools” than opioids in managing pain.
National Center for Complementary and Integrative Health (NCCIH) Director Helene Langevin said in a blog post on Tuesday that much of the federally funded research on marijuana to date has “narrowly focused on the potential harms” of THC.
She argued that it’s important gain a more holistic scientific understanding of the plant and its components’ potential benefits and harms.
It’s with that objective in mind that NCCIH, which falls under the National Institutes on Health (NIH), recently published a “Request for Information” (RFI), soliciting feedback from the scientific community “about its interest in and barriers to research on the health effects of cannabis and its constituents.”
In my recent message, I stress the need to do more research on the potential clinical uses of #cannabis products and identify barriers to conducting this research. Please consider responding to our Request for Information on this topic. https://t.co/HglC86Xz6N #DirectorsMessage
— Helene M. Langevin, M.D. (@NCCIH_Director) August 30, 2022
As Langevin pointed out, a main barrier that’s hindered studies into cannabis is the fact that it remains a Schedule I drug under the Controlled Substances Act (CSA).
She said that “some researchers may not know how to navigate the process of securing a Schedule 1 license,” while others “might be hindered by the lack of broadly accepted measures for what constitutes a ‘dose’ or modes of administration.”
“Thus, a key step in successfully generating more scientific evidence around the potential clinical uses of cannabis products is to identify barriers to conducting research and subsequently develop approaches that can help overcome them,” the official said. “The RFI responses we receive will help broaden our understanding of the research infrastructure needed to foster rigorous studies and identify areas of interest within the field.”
Other top federal health officials have similarly recognized how the current legal status of Schedule I drugs like marijuana has discouraged scientists from going through the onerous registration process required to obtain the drugs for studies. Even the head of the National Institute on Drug Abuse (NIDA) said she personally avoids studying Schedule I substances because of those bureaucratic challenges.
“While the comments we receive in response to this RFI will help guide future directions, NCCIH is currently working to advance this area of research,” Langevin said, adding that her department also recently posted a Notice of Special Interest (NOSI) to promote “mechanistic research” into minor cannabinoids like CBG, CBN and delta-8 THC.
“Together, these activities are timely, especially given the potential role of cannabinoids in managing pain,” the director said. “The overreliance on opioids has created a public health crisis and incalculable losses across the nation. Driving research that could yield new, potentially safer tools that meet the needs of people who suffer from chronic pain is an essential step in addressing the problem at its root.”
Langevin said that she views NCCIH’s “ongoing work in cannabinoids research as a natural extension of our broader effort to advance the scientific understanding of whole person health.”
In her recent message, @NCCIH_Director announces a new Request for Information that seeks insights and perspectives on identifying barriers to #cannabis research and approaches that can help overcome these barriers. https://t.co/G2nGPQrASX #DirectorsMessage
— NIH NCCIH (@NIH_NCCIH) August 30, 2022
But doing so means taking a more evolved approach to marijuana research—one that isn’t almost exclusively focused on the potential harms of THC, as has historically been the case in the U.S., but also promotes studies into the therapeutic potential of the wide range of marijuana constituents.
“Our commitment to whole person research means that, rather than focusing on singular body parts, systems, or interventions, we widen our lens to better recognize the interconnections between each of these. Most research to date on cannabinoids has narrowly focused on the potential harms of tetrahydrocannabinol (THC). As a result, little is understood about the other 110 cannabinoids and 120 terpenes contained within the plant that interact with multiple body systems. Gaining new insights on their properties, used together or in isolation, as well as potential therapeutic uses will open up new directions in whole person research.”
“It’s time to chart a path forward—one that can lead to new understanding and reveal potential novel applications for these complex compounds,” Langevin concluded. “For those who have insights and perspectives, I hope you will share them in response to the RFI and help inform our directions.”
NIH first posted the NCCIH-led RFI on cannabis research barriers earlier last month, but a spokesperson told Marijuana Moment that it was published prematurely, so the department temporarily took it down until Monday, when it was republished.
Eight of NIH’s component agencies, including NCCIH, are partnering on the new initiative.
“Cannabis has been used medicinally for over 3,000 years,” the reposted notice says. “Recently, there has been growing interest from health care providers and the public in the potential medicinal properties of cannabis-related products.”
While the Food and Drug Administration (FDA) has approved cannabinoid-based therapies for select conditions, NCCIH acknowledged that the majority of states have adopted medical cannabis programs for patients with various conditions—and it said there is “often inadequate scientific research to support the benefit of their intended use” in those states.
“As a result, there is a need to strengthen the scientific evidence underlying the clinical impact and potential harms of cannabis products for specific diseases and conditions,” it said. “Some researchers have reported barriers that hinder an expansion of research.”
The agency listed examples of reported research barriers, including a lack of experience with state and federal regulations for marijuana studies, “unforeseen costs and effort” to obtain research licenses, the “availability of and access to appropriate cannabis and cannabis products/constituents”—including specific strains—and insufficient measurement tools to analyze the impacts of cannabis use.
The note about access to “appropriate cannabis” appears to reference the fact that, for decades, scientists authorized by the Drug Enforcement Administration (DEA) to study marijuana have only been able to obtain products from a single source: a government-run cannabis farm at the University of Mississippi.
DEA recently approved additional manufacturers—a point that the White House touted on Monday as an example of how the Biden administration is doing something on cannabis policy—and NIDA is actively seeking one new contractor to supply cannabis for studies.
Still, many have argued that scientists should also be allowed to get marijuana from state-legal retailers so that their studies more accurately reflect the products being used in commercial markets.
“NIH is seeking to better understand these issues and potentially develop strategies to overcome them,” the RFI says. “To that end, NIH seeks input from the research community regarding these and additional barriers, scientific interests, and needs related to therapeutic cannabis or cannabinoid research.”
“NIH is interested in gathering information about barriers, scientific interests, and needs associated with therapeutic cannabis or cannabinoid research from investigators conducting or interested in conducting research on cannabis, cannabinoid phytochemical constituents, and related compounds (synthetic compounds, terpenes, etc.). Such information will be useful to NIH as it seeks to address the research infrastructure needs and identify areas of interest within this field.”
For this request, NIH said there are six primary areas of interest: 1) a broad overview of what kinds of cannabis studies scientists want to explore; 2) the existing and “desirable” scientific infrastructure for such studies; 3) research barriers like marijuana’s Schedule I status; 4) NIH activities that can “help expand the field” of medical cannabis research; 5) resources needed to carry out the studies—including access to different “marijuana varieties, strains, constituent chemotypes, or specific cannabinoids”; and 6) access to regulatory, clinical and scientific information about the plant and its constituents.
Interested parties have until October 15 to respond to the RFI.
Here are the institutes that are involved in this latest notice on research barriers: NCCIH, NIDA, National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Dental and Craniofacial Research (NIDCR) and National Cancer Institute (NCI).
President Joe Biden signed a large-scale infrastructure bill last year that includes provisions aimed at allowing researchers to study the actual marijuana that consumers are purchasing from state-legal dispensaries. But the legislation, rather than immediately giving scientists access to the products, lays out a fairly long-term plan for considering the issue and then potentially making that happen down the line.
Meanwhile, NIDA also announced in June that it plans to provide $1.5 million in funding to support researchers who can develop a medical marijuana registry to track everything from how patients are obtaining and consuming cannabis to their health outcomes.
The agency has also expressed interest in funding studies on differing cannabis regulatory models that are in place in states across the country.
Separately, a bipartisan duo of congressional lawmakers recently filed a bill to set a federal marijuana research agenda and create a designation for universities to carry out cannabis studies with federal grant money. The legislation from Reps. Scott Peters (D-CA) and Dave Joyce (R-OH) is titled the “Developing and Nationalizing Key Cannabis Research Act,” or the DANK Cannabis Research Act.
The bill filing came on the same week that the U.S. House of Representatives separately voted to approve another bipartisan marijuana research bill that’s also intended to expedite and simplify the process of receiving authorization to study the risks and benefits of marijuana.
That measure, which would not allow researchers to study dispensary cannabis, is expected to be taken up by the Senate in short order before potentially being sent to the president’s desk.
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