What are federal cannabis research funding priorities?
This month, Colorado State University Pueblo hosted David Shurtleff, deputy director of the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH), to address the question. (Cannabis Wire covered a previous CSU Pueblo webinar, which was focused on cannabidiol use in dogs.)
Research at the NCCIH falls into two buckets: mind and body practices, like meditation, acupuncture, spinal manipulation, or yoga, and natural products, primarily botanicals. Research also tends to focus on symptom management of things like stress, anxiety, depression, and on pain management.
Shurtleff noted that 4.1 million adults were treated with opioids in 2000. That number jumped to well over 10 million adults just over a decade later.
“Given the current opioid epidemic, it’s really important that we invest more research to find alternatives to opiate analgesics that are less addictive, certainly less harmful,” Shurtleff said.
The “overwhelming reason” that patients seek medical cannabis, Shurtleff said, is to help treat chronic pain, followed by muscle spasms, nausea, and post traumatic stress disorder. To illustrate this point, he discussed a study of 2,700 participants that had used medical cannabis at least once in the past three months. When asked what the medical cannabis replaced, Shurtleff said, respondents reported “extra opioids.”
“We’re very excited about the research we’re doing. We think that you will have an important impact on the public health crisis of opioid use,” Shurtleff said, referencing cannabis researchers.
“But, certainly there are many research challenges and barriers,” he continued, “associated with studying cannabinoids.”
Cannabis researchers have for years emphasized how difficult it is to conduct research on the plant, and its cannabinoids, and Congress has debated how to strip some of these barriers. For example, in September, the House Committee on Energy and Commerce voted unanimously by voice in favor of HR 3797, the Medical Marijuana Research Act of 2019, which would “amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes.” And in March, the House Committee on Veterans Affairs discussed and passed two bills related to medical cannabis and veterans.
“The research challenges and really the slow pace of research into cannabis and its potential benefits and risks and the lack of uniformity across state policies, had led to patients and providers in a bit of a conundrum. The lack of FDA approval presents a real concern for many clinicians prescribing or recommending the use of medical marijuana,” Shurtleff said.
While medical cannabis products are available in dozens of states, the “issue,” Shurtleff said, is that they “have not been rigorously tested for safety and efficacy for really any medical condition, and product integrity, of course, can be a concern.”
Shurtleff added, “Really, we don’t know what combinations of these chemicals are safe. What is the most effective for pain management? You know, these questions have not been really adequately studied.”
Only one cannabis-based medicine has wound its way through the Food and Drug Administration approval process, and that’s GW Pharmaceuticals’ Epidiolex, a CBD-based extract for patients with rare epilepsies, which was approved in June 2018.
Shurtleff highlighted cannabinoid research currently underway: Axim Biotech in the Netherlands, for example, is working on developing a cannabinoid-based chewing gum to treat irritable bowel syndrome, while Nemus Bioscience, out of Long Beach, California, is partnering with the University of Mississippi on the development and commercialization of bioengineered cannabinoid-based medicine to treat chemotherapy-induced peripheral neuropathy. Intec Pharma is working on an “accordion pill,” which Shurtleff said is “a fascinating technology for the release of cannabidiol and THC for pain management.”
Cannabichromene (CBC) and cannabigerol (CBG) are of particular interest to NCCIH, because preliminary data suggests that “they have an affinity” for the receptors known to be important targets for pain perception and for the treatment of pain.
“We’re very excited about looking more into these minor cannabinoids as possible analgesics,” Shurtleff said.
In 2019, the NCCIH issued a request for applications to advance research on the entourage effect of cannabis, and to explore pain relieving properties and “mechanisms of action” of diverse phytochemicals in cannabis, including the minor cannabinoids.
“We issued a request and the response really was just overwhelming. We received an overwhelming number of applications,” Shurtleff said, adding that eleven proposals were funded. “We are open to, and actively soliciting, additional applications in this area,” he said.
As far as other funding opportunities, the NCCIH is partnering with the National Institute of Neurological Diseases and Stroke through the IGNITE program, which stands for the Innovation Grants to Nurture and Translational Efforts, aimed at developing “robust, validated analgesic assays” for novel natural products.
The NCCIH is also reaching out to small businesses through their Small Business Innovation Research Program and our small business technology transfer program, in an effort to bring “innovation in natural products,” Shurtleff said.
Finally, Shurtleff said that the NCCIH has “rebooted” its natural product research program.