With a widespread market and popular proselytizers, from high-end “aspirational” lifestyle guru Gwyneth Paltrow to television M.D.-to-the-masses Dr. Oz, CBD oil is fast becoming a marketable goldmine. However, its efficacy exists in a gray area between snake oil and over-the-counter miracle drug, with only one CBD medicine on the market with FDA approval.
The molecule cannabidiol (CBD) is touted as a potential game-changer for numerous neurological and physical ailments, but is hindered by classification as a Schedule 1 drug, which makes clinical testing a challenge. But that hasn’t stopped hundreds of businesses from marketing products with CBD oil. A brief list of items available online, in stores, and at boutiques include: gummies, tea, bath bombs, body lotion, coffee, cold-pressed olive oil, seltzer, caramels, face serum, foot balm, pills, and even salsa. You can find several bars in New York City that serve CBD cocktails, and a dessert menu featuring poached pears with CBD tincture. Dosages and potency of CBD products available over the counter in dispensaries and online vary, and their efficacy is unknown due to an absence of randomized control trials.
CBD is a molecule within the cannabis, or marijuana, plant. THC—short for delta-9-tetrahydrocannabinol—is also a molecule in the plant. THC is the primary psychoactive ingredient in the plant; it is responsible for the “high,” or feeling of euphoria, that you might experience when you use traditional cannabis. Hemp is a legal term to describe cannabis with little to no THC in it (less than 0.3 percent). Hemp is being used more and more to make CBD oils and other products, those things that traditionally won’t get you “high.”
“Think about the CBD market as being within two buckets: The fad side, and the medicinal side,” says Marcel Bonn-Miller, an adjunct assistant professor of psychology in the Perelman School of Medicine. “Currently there is only one available CBD drug on the market that is FDA approved—Epidiolex—and it is a Schedule 5 drug.”
Epidiolex treats two rare seizure disorders: Dravet and Lennox-Gastaut syndromes. The manufacturer took the traditional pharmaceutical route to get FDA approval, which few other companies are working to do. Epidiolex was sourced from the cannabis plant in the U.K., and imported into the U.S. to be studied as a Schedule 1 drug at the time, for seizures.
Despite an absence of randomized control trials in available products other than Epidiolex, CBD oils, lotions, vape cartridges, tinctures, suppositories, and foodstuffs have been marketed by companies as a treatment for everything from autism, diabetes, depression, alcoholism, schizophrenia, joint pain, anxiety, insomnia, to menstrual cramps.
“Researchers are working towards better understanding the effects of CBD on sleep and anxiety. At the moment, we don’t know whether CBD works for these conditions and if it does, how much is needed to derive a beneficial effect,” explains Bonn-Miller. “We only have those data on Epidiolex for two rare seizure disorders. We don’t know the dosages needed for any of the other products on the market. None of these products are pure CBD; they all have other ingredients (THC, other cannabinoids, terpenes, etc.) and the ratio of CBD to those ingredients often varies within and across products. Just because Epidiolex works for seizures doesn’t mean that ‘Brand X’ CBD oil will as well. Even if ‘Brand X’ CBD oil works for seizures, we can’t necessarily infer dosing from Epidiolex. Researchers are also beginning to find contaminants in available products. There is a reason we have the drug development process, and a reason we work with the FDA: to assure a drug is safe and can treat a given indication within a certain dose range.”
So how does a seizure treatment make its way into bath bombs, desserts, and luxury gift guides on Goop? Largely through anecdotal evidence, marketing, and popularity. CBD sales in the U.S. exceeded $500 million in 2018, and Epidiolex sales accounted for an additional $30 million. By 2020, the market forecast projects more than $1 billion in annual sales.
Researchers are just scratching the surface on the medicinal side. “From a drug perspective, the research is in its infancy,” Bonn-Miller says. “The problem is that untested and unregulated products are everywhere. Like the vitamin market and herbal supplements, CBD is largely unregulated. We did studies of CBD products on the market and found that product labels inaccurately described what was in the bottle; 70 percent of products either had significantly more or significantly less CBD than labeled.”
He also says that there haven’t been any rigorous clinical studies measuring the efficacy of any of the topical CBD products out on the market. “At best, these companies may run Phase 4 studies, where consumers who buy a given product are asked to report on whether or how it works for them. That’s a pretty low bar,” Bonn-Miller adds.
The popularity and promise of the therapeutic benefits of CBD has an enormous effect on people. Published studies have tested incredibly high doses of CBD: effects on anxiety have been documented with doses between 250 and 600 milligrams per day. For epilepsy, doses have ranged from 5 milligrams per kilogram to 20 milligrams per kilogram or more. Any documented benefit of CBD in rigorous placebo-controlled trials has required hundreds to over 1,000 milligrams a day.
Now take a look at that CBD bottle in your cupboard. Depending on the concentration, that could be an entire bottle per day. A lot of people take 15 milligrams or less a day. “It’s not nearly enough,” says Bonn-Miller. “There are no data to suggest that 15 milligrams before bed will do anything. But the expectation is so high that people start to believe it is working. The placebo effect is evident, even with seizures.”
If Bonn-Miller’s predictions are right, CBD may top Apple’s top 10 gift ideas again at the end of 2019. But, he points out that CBD is only one of 120 cannabinoids in the cannabis plant. People will eventually tire of CBD—and there may be another cannabinoid molecule to get excited about.
Source: University of Pennsylvania