The Drug Enforcement Administration (DEA) proposed rules earlier this year that would officially reclassify cannabis as a medicine rather than an illegal narcotic. That’s exciting news for researchers, but does the reclassification mean cannabis could soon move from the pharmacy to the drugstore?
According to experts, it is not that simple.
Peter Grinspoon, MD, a professor at Harvard Medical School and author of the book Seeing Through the Smoke, says the result of the rescheduling will be “a little bit disjointed.”
Under the new rules, cannabis would be reclassified as a Schedule III drug, meaning that all cannabis-based medications would likely require FDA approval and a doctor’s prescription. This means it would still be more closely regulated than alcohol and tobacco, Grinspoon says, even though it is “safer “In the meantime, cannabis will continue to be available at state-legal dispensaries without FDA approval.
The most important change is symbolic, Grinspoon says, because “the U.S. government again admit that (cannabis) is a medicine.” It is currently very difficult to get permission from the federal government to conduct research on the cannabis plant. Grinspoon believes reclassification could make it easier to study medical cannabis by easing stigma and legal restrictions.
“Cannabis is not magically different from anything else,” he says. “It’s less harmful than opiates, but it still has downsides, and if you’re going to use it, you should want to know the downsides.” People on both sides of the debate “are going to be forced to deal with reality.”
Grinspoon is particularly interested in research into whether cannabis can actually fight disease.
“Cannabis is very good at relieving symptoms. We know that. We know it helps with chemotherapy-induced nausea and vomiting, we know it helps with pain. I’m curious to see if cannabis can help change the course of disease rather than just treating the symptoms,” he says. “Like in the test tube, Cannabis is very good at killing cancer cellsbut it has not yet been shown that cannabis can cure cancer in humans, only in a test tube.”
Igor Grant — long one of the few people allowed to study cannabis in a lab — thinks the drug could be especially useful for certain conditions that are resistant to existing treatments. Grant is a psychiatrist and director of the Center for Medical Cannabis Research at the University of California, San Diego, which was founded in 2000 to further California’s mission of Marijuana Research Act of 1999By changing the schedule, those decades of research could benefit a much larger group of patients.
“Neuropathic pain continues to be a major area of focus,” Grant says. It’s associated with many conditions, including HIV infection, multiple sclerosis and spinal cord injury, and is “difficult to treat and really affects quality of life. If you can’t sleep at night because of this condition and the medications you’re taking aren’t helping much, that’s bad.”
Jahan Marcu, author of the book Cannabis Innovationson the regulation of cannabis and hemp, says cannabis-derived medicines will likely have to be synthetic or extensively refined to be approved by the FDA.
There are already a number of FDA-approved drugs on the market that are related to cannabis. Dronabinol, first approved in 1985 contains a synthetic version of THC, against nausea caused by chemotherapy and against AIDS-related anorexia.
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More recently, the Agricultural Act 2018 created the opportunity for medicines that are actually derived from the cannabis plant. It lifted restrictions on products containing less than 0.3% delta 9 THC, thought to be the most intoxicating component of the plant. So far, the FDA has approved only one medicine derived from the cannabis plant – Epidiolexa pharmaceutical formulation of CBD that treats rare seizures. Reclassification could mean the FDA would approve similar products made from plant-derived delta 9 THC, though the agency rarely approves plant-derived medicines.
Even drugs that originally came from plants are often manufactured. “People figured out what the active molecules were, and then they figured out how to make them,” Grant says. Still, he hopes that the FDA’s approval of Epidiolex means other drugs derived from cannabis plants will be approved as well.
Marcu says this type of medication “can provide precise dosing and consistency, but does not contain the full spectrum of compounds that a crude extract provides.”
The FDA requires that medications be precisely formulated to ensure safety and consistency. Since the cannabis plant contains hundreds of different cannabinoids and terpenes, it is unlikely that the FDA would ever approve unrefined products like those available in dispensaries.
Grinspoon says separating cannabis compounds gets in the way of the “entourage effect” of all those compounds. He says that while AIDS patients have access to FDA-approved synthetic cannabis, many prefer the whole plant for that reason. He hopes to see a more diverse range of cannabis-derived medicines, not just formulations of the major compounds, CBD and THC. Many cannabinoids have not been studied much, but show promise.
“There’s one called THCV, which is the appetite and blood sugar levels And increases insulin sensitivity,” he says. “I mean, that’s a pharmaceutical goldmine to try to dig into what each of those things does and how we can exploit them medically. It’s just going to be endless.”