SILVER SPRING, Md. — As one FDA official tweeted following the agency’s public hearing Friday on medical cannabis, „We will work as quickly as possible to define a way forward. Appreciate a speaker’s observation: 'You guys have a tough job. Good luck with that.’ Indeed.”
The hearing was filled with presentations ranging from experts’ scientific summaries to anecdotes from family members of consumers who suffered from cannabis addiction. The health professionals’ input covered much of the spectrum.
Researchers and other health professionals almost unanimously urged the agency to help increase research into cannabis — while also suggesting how it could regulate cannabidiol (CBD) products proliferating the market and further improve public health regarding cannabis consumption.
Many of their remarks addressed CBD, commonly perceived as being non-psychoactive — though as one speaker noted, that doesn’t mean it’s totally benign.
„We have known for a while that CBD as well as THC (tetrahydrocannabinol, the well-known psychoactive cannabinoid) can cause drug interactions,” said Barry Gidal, PharmD, of the University of Wisconsin-Madison. CBD could interact with many drugs, he added, but „a lot is unclear.”
So much about cannabis in general is unclear, said Igor Grant, MD, who directs the Center for Medical Cannabis Research at the University of California San Diego. „We are rapidly getting behind the curve [scientifically] in terms of what is happening in the real world and what patients are utilizing. We need to take steps to catch up.”
Research into THC and CBD is limited, he said, and barriers at the federal level keep it that way. Ryan Vandrey, PhD, of Johns Hopkins University, noted that not only are THC and marijuana extracts designated as Schedule I drugs, so is synthetic CBD.
Grant recommended examining the concept of a therapeutic window, delving into what cannabis doses are large enough to help consumers but small enough to prevent them from getting high; studies have shown that smaller doses yield medical benefits. Vandrey said that while CBD and THC garner the most attention, researchers should also look into the other 80-plus cannabinoids found in cannabis.
Sharing state registry data could also help, health professionals said. Rick Kingston, PharmD, of the University of Minnesota, suggested granting the FDA access to his state’s database, which he said has more than 16,000 registered patients.
Larry Walker, PhD, of the University of Mississippi’s School of Pharmacy, and Sue Sisley, MD, of the cannabis-focused Scottsdale Research Institute in Arizona, recommended the FDA push the Drug Enforcement Administration to ease its policies regarding cannabis. Walker’s team is a National Institute on Drug Abuse contractor but still cannot access cannabis extracts, he said, because of DEA restrictions. A DEA policy likewise is blocking Sisley’s team from obtaining the cannabis it needs to conduct phase III clinical trials, she said.
Walker also called for the FDA to conduct „basic” clinical studies, and erect national cannabinoids testing and adverse events reporting programs.
Elise Weerts, PhD, of Johns Hopkins, lamented that, while her 21-year-old son can buy cannabis and instantly consume it, she has to traverse DEA and FDA regulations to access the plant for legitimate research — which takes months. „Is cannabis good or bad? The answer is it is a little of both,” Weerts said. „We need to evaluate health claims. We can’t do that if research can’t access these compounds. … We need to understand the risks and benefits; there’s clearly both.”
Many health professionals are concerned about a snake oil salesman ethos that appears to have invaded the CBD market, with claims that the compound is effective against everything from schizophrenia to cancer.
While some products are tested and ingredients fully listed, many are not. Michelle Peace, PhD, and her team at Virginia Commonwealth University’s Department of Forensic Science have discovered „dangerous synthetic materials” in electronic vaporizers purporting to deliver CBD. „Consumers wanting to buy CBD have no idea if it also has dangerous drugs,” she said.
Some CBD products sold as hemp have also been found to contain as much as 6.4 mg of THC per mL, Vandrey noted, not far from the roughly 10 mg known to impair cognitive performance. The FDA should „immediately” establish regulations governing quality control and product labeling for CBD products, Vandrey said.
Not all epilepsy patients can access necessary pharmaceuticals, said Jacqueline French, MD, of the Epilepsy Foundation and New York University School of Medicine. Many are thus taking CBD without consulting a medical professional — unaware of CBD products’ variability. „It’s essential there is consistency with the products,” she said, in addition to the FDA creating manufacturing standards, and increasing the availability of „important information” such as the potential for interactions and side effects.
Following last year’s FDA approval of Epidiolex, the cannabis-derived drug to treat some epileptic seizures, Alice Mead, representing manufacturer Greenwich Biosciences/GW Pharmaceuticals, called on the FDA to differentiate consumer goods and FDA-approved medications made from cannabis. „For some patients, using unapproved cannabis products is the only option, but this is not the idea,” she said. „That’s why we support a robust regulation effort” that would lead to more FDA-approved cannabis medications.
Some speakers noted that they learned nothing about cannabis during their medical training. Private practice physician Lucille Vega, MD, called for „more education for our physicians. Why? Because people are coming to me, coming to the ER asking.”
Speakers representing healthcare foundations also urged the FDA to take action. James Beck, PhD, of the Parkinson’s Foundation, noted the potential for cannabis to treat that disease, but said much more research is needed.
Said Abernethy, via tweet: „For CBD, info presented suggests that many consumers think that regulatory pathways are fully in place to keep products safe. Meanwhile speakers reinforced that regulatory pathways are unclear. We must sort this out in [the] service of public health.”
Stuart Titus, MD, of Medical Marijuana Inc., called for the FDA to create a controlled manufacturing environment, noting that many CBD-producing companies are already trying to behave responsibly. He is confident the the FDA will eventually regulate cannabis as a dietary supplement while simultaneously enhancing standards all supplements must meet, he said.
„We have a tremendous public demand for this,” he noted, perhaps unnecessarily.
The FDA is accepting further comments on a docket until July 2; it then plans to convene a workgroup co-chaired by Abernethy and Lowell Schiller (principal associate policy commissioner) to examine its next steps — including „to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed,” then-FDA commissioner Scott Gottlieb said shortly before leaving office in April.
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