Cannabis Will Likely Soon Be Legally Classified as Medicine. But Medicine for What?
The Drug Enforcement Administration (DEA) proposed rules earlier this year that would officially give cannabis status as a medication rather than an illegal narcotic. This is exciting news for researchers, but does rescheduling mean that cannabis could soon move from the dispensary to the drug store? Experts say it’s not that simple.
Peter Grinspoon, a physician, Harvard Medical School instructor, and author of the book Seeing Through the Smoke, describes the upshot of rescheduling as “a little bit incoherent.” Under the new rules, cannabis would be reclassified as a Schedule III drug, meaning any cannabis-based medications would likely require FDA approval and a doctor’s prescription. This reclassification would make it more regulated than alcohol and tobacco, despite being “safer by every metric,” according to Grinspoon. Meanwhile, cannabis will continue to be available at state-legal dispensaries without the FDA’s signoff.
Symbolic and Practical Changes
Grinspoon emphasizes that the most important change is symbolic because “the US government is once again admitting that [cannabis] is a medicine.” Currently, it is very difficult to get federal permission to research the cannabis plant. Grinspoon believes rescheduling could make it easier to study medical cannabis by easing stigma and legal restrictions.
“Cannabis isn’t magically different from everything else,” he says. “It’s less harmful than opiates, but it still has harms, and if you use it, you should want to know the harms.” People on both sides of the debate “are going to be sort of forced to contend with reality.”
Grinspoon is particularly keen to see research on whether cannabis could actually fight diseases. “Cannabis is very good at alleviating symptoms. We already know that. We know that it helps with chemotherapy-induced nausea and vomiting, we know that it helps with pain. I’m interested to know if cannabis can help modify the course of diseases versus just treat the symptoms,” he says. “Like in the test tube, cannabis is very good at killing cancer cells, but cannabis hasn’t been shown to cure cancer in humans yet, just in the test tube.”
Potential for Disease Treatment
Igor Grant, a psychiatrist and director of the Center for Medical Cannabis Research at the University of California, San Diego, established in 2000 to help fulfill the mission of California’s 1999 Marijuana Research Act, believes the drug could be especially useful for certain conditions that resist existing treatments. Rescheduling would mean those decades of research could benefit a much larger group of patients.
“Neuropathic pain continues to be an important direction,” says Grant. It’s associated with many conditions including HIV infection, multiple sclerosis, and spinal injuries, and is “difficult to treat, and really impairs quality of life. If you can’t sleep at night because of this condition, and the meds you’re taking are not very helpful, that’s bad.”
Pathway to FDA Approval
Jahan Marcu, author of the book Cannabis Innovations, on cannabis and hemp regulation, says that to get FDA approval, cannabis-derived drugs would likely need to either be synthetic or extensively refined.
There are already some FDA-approved medications related to cannabis. Dronabinol, first approved in 1985 for chemotherapy-induced nausea and Aids-related anorexia, contains a synthetic version of THC. More recently, the 2018 Farm Bill created the possibility for medications actually derived from the cannabis plant. It lifted restrictions on products containing less than 0.3% delta-9 THC, believed to be the plant’s most intoxicating component. So far, the FDA has only approved one cannabis plant-derived drug – Epidiolex, a pharmaceutical-grade formulation of CBD that treats rare seizures. Rescheduling could mean that the FDA approves similar products made from plant-derived delta-9 THC, although the agency rarely approves plant-derived drugs.
Even drugs that originally came from plants tend to be manufactured. “People figured out what were the active molecules, and then they figured out how to make those,” Grant says. Still, he is hopeful that the FDA’s approval of Epidiolex will mean other cannabis plant-derived medications will be approved.
Marcu says this type of medication can “offer precise dosing and consistency but will lack the full spectrum of compounds provided by a crude extract.”
The “Entourage Effect” and Future Research
The FDA requires drugs to be precisely formulated to assure safety and consistency. Since the cannabis plant contains hundreds of different cannabinoids and terpenes, it’s unlikely that the FDA would ever authorize unrefined products, like those available in dispensaries.
Grinspoon says that separating out cannabis’s compounds hinders the “entourage effect” of all of them working in concert. He says that even though Aids patients have access to FDA-approved synthetic cannabis, many prefer the whole plant for this reason. He hopes for a more diverse array of cannabis-derived medicines, not just more formulations of its biggest components, CBD and THC. Many cannabinoids have not yet been researched much but show promise.
“There’s one called THCV, which lowers appetite and blood sugar and increases insulin sensitivity,” he says. “I mean, that’s a pharmaceutical goldmine to try to dig into what each of those do and how we could exploit them medically. It’s just going to be sort of infinite.”
