Earlier this year, the Drug Enforcement Administration (DEA) proposed rules that would give cannabis status as a medication rather than an illegal drug – which is exciting news for researchers, but rescheduling will mean that marijuana could soon move from the pharmacy to the drug store move?
Experts say it’s not that simple.
Peter Grinspoon, a physician, Harvard medical school instructor and author of the book Seeing Through the Smoke, says that the result of rescheduling will be “a little disjointed.”
Under the new rules, cannabis will be reclassified as a schedule III drug — meaning any cannabis-based medication will likely require FDA approval and a doctor’s prescription. This will mean it will still be more regulated than alcohol and tobacco, says Grinspoon, even if it is “safer by every measure”. In the meantime, cannabis will continue to be available at state-legal dispensaries without the FDA’s sign-off.
The most important change is symbolic, says Grinspoon, because “the American government is again admit it [cannabis] is a medicine.” It is currently very difficult to get permission from the federal government to research the cannabis plant. Grinspoon thinks rescheduling could make it easier to study medical cannabis by easing stigma as well as legal restrictions.
“Cannabis is not magically different from everything else,” he says. “It’s less harmful than opiates, but it still has harm, and if you use it, you have to want to know the harm.” People on both sides of the debate “are going to be kind of forced to contend with reality”.
Grinspoon is particularly keen to see research into whether cannabis can actually fight disease.
“Cannabis is very good at relieving 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 in knowing if marijuana can help change the course of disease versus just treating the symptoms,” he says. “Like in the test tube, cannabis is very good at killing cancer cellsbut cannabis has not yet been shown to cure cancer in humans, only in the test tube.”
Igor Grant – long one of a select few authorized to study cannabis in a laboratory – believes the drug could be particularly useful for certain conditions that resist existing treatments. Grant is a psychiatrist and director of the Center for Medical Cannabis Research at the University of California, San Diego, which was established in 2000 to further the mission of California’s 1999 Marihuana Research Act. Rescheduling would mean those decades of research could benefit a much larger group of patients.
“Neuropathic pain remains an important area,” says Grant. It is 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 medicine you’re taking isn’t very helpful, that’s bad.”
Jahan Marcu, author of the book Cannabis innovationson regulation of cannabis and hemp, says that in order to gain FDA approval, cannabis-derived drugs are likely to have to be either synthetically or extensively refined.
There are already some FDA-approved drugs on the market related to cannabis. Dronabinol, first approved in 1985 for chemotherapy-induced nausea as well as AIDS-related anorexia, contains a synthetic version of THC.
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More recently, the 2018 Farm Bill has created the possibility for medication that actually comes 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 approved only one drug from the cannabis plant – Epidiolex, a pharmaceutical-grade formulation of CBD that treats rare seizures. Rescheduling could mean the FDA approves similar products made from plant-derived delta 9 THC, although the agency rarely approves plant-derived medicines.
Even drugs originally derived from plants tend to be manufactured. “People figured out what the active molecules were, and then they figured out how to make them,” says Grant. Still, he’s hopeful that the FDA’s approval of Epidiolex will mean other cannabis plant-derived drugs will be approved.
Marcu says this type of medication can “provide precise dosing and consistency, but will not provide the full spectrum of compounds provided by a crude extract”.
The FDA requires that medicines 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 will ever approve unrefined products, such as those available in pharmacies.
Grinspoon says that the excretion of cannabis compounds hinders the “corollary effect” of everyone working together. He says that although AIDS patients have access to FDA-approved synthetic cannabis, many prefer the whole plant for this reason. He hopes for a more diverse range of cannabis-derived medicines, not just more formulations of its main components, CBD and THC. Many cannabinoids have not yet been extensively researched, but show promise.
“There is one called THCV, which lowers appetite and blood sugar and increase insulin sensitivity,” he says. “I mean, it’s a pharmaceutical gold mine to try to dig into what each of them do and how we can exploit them medically. It’s just going to be kind of infinite.”
