The display at my local gas station is an impressive one. CBD oils – from no fewer than three different manufacturers and in half a dozen flavors – are packed, label-out, behind a plastic shield invitingly close to the chewing gum and take-a-penny tray.
Depending on where you live, you might have noticed it yourself. CBD (that’s cannabidiol for those not hip to the lingo) comes in capsules, vape cartridges, good, old-fashioned dropper bottles. Sawbones did an excellent segment on the substance a few months ago, and even found CBD sold in teas and energy drinks.
There’s a lot of hype about this stuff, and the science behind it is usually played pretty fast and loose. Good luck finding an objective article with just a Google search – the first several pages are a healthy mix of hagiographies and hit pieces. Most of the available reading about CBD is completely anecdotal, and there seems to be little room in the conversation for moderates. Only the smallest morsels of peer-reviewed research are to be found. This doesn’t necessarily mean that it’s ineffective, so much as it is poorly understood.
Where is all the confusion coming from?
What is CBD?
If you’ve read this far, you probably already know the answer to this question. But let’s suppose you don’t.
Cannabidiol is one of the many dozens of cannabinoids found in the cannabis plant. A cannabinoid is a class of chemical that acts on a type of specific receptor in the brain. The physical effects can be muted, as is the case with CBD. Others have more pronounced effects, like the more famous THC. CBD does not get the user high.
Until recently CBD was considered a schedule I drug, deemed to be without medical use and highly addictive. It seemed unable to shake the stigma of being a derivative of marijuana; and despite advances in our understanding of the substance, scientists remain skeptical of the often grandiose claims of its effectiveness.
In June, CBD got a big break. In a major first, the FDA approved Epidiolex, an oral solution whose active ingredient is CBD, for use in treating patients with rare and serious forms of epilepsy that have few other modes of treatment. No longer fitting the definition of a schedule I drug, CBD was changed to the much-less-scary sounding schedule V (low potential for abuse and with medically accepted uses).
Claims of CBD’s effectiveness in treating any other condition are anecdotal at best. The science simply has yet to be done. This is an unsatisfying answer to many, but a reality when dealing with a substance so intricately snared in red tape.
Most CBD is Still Illegal
Thought you were almost home free right? Here’s where things get more complicated.
As you can see on the official list of substances restricted by the Controlled Substances Act, only “approved cannabidiol drugs” are given a schedule V listing. An approved cannabidiol drug is defined as “a drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains Cannabidiol derived from cannabis and no more than 0.1% residual THC.”
The language is important here, because to date, only one CBD-based drug has gained FDA approval – Epidiolex. That means CBD manufactured and sold by anyone else in the United States is still in violation of the federal law, although of course, states have their own sets policies on cannabis products. It’s important to note that this is not without reason. Many of the “gas station CBD” oils being sold over-the-counter aren’t CBD at all, instead containing other oils or potentially harmful substitutes. Without some aspect of oversight from the FDA, there is no guarantee that what’s in your bottle is actually CBD.
So unfortunately, even if your health store CBD is 100% pure, even if it works – if it isn’t Epidiolex, it’s probably illegal.
Epidiolex – The CBD Market, Cornered
Orphan drugs are drugs that benefit only a very small part of the population – fewer than 200,000 patients, as outlined by the Orphan Drug Act of 1983.
To spare you a long explanation, when the FDA grants a substance orphan drug status, some extra perks come with it. It’s a pretty sweet deal, and some would say it has to be – these drugs can be difficult to develop, and expensive. Among other things it includes a 50% tax credit on the cost of the clinical trials, but perhaps what is most appealing is the seven year period of market exclusivity that comes with an orphan drug designation. During this window, nobody may sell a competing drug for the same uses. This effectively grants the manufacturer a monopoly, letting them charge what they like for the drug.
For some pharmaceutical companies, developing orphan drugs can be a huge risk, and a major decision to be made. Others, however, make the bulk of their profit off orphan drugs alone.
Before I continue, it’s important to understand that receiving orphan drug status is not the same as receiving overall approval for a drug – without full approval, the number of patients that can be treated with a drug is set at a fixed, low number for study purposes.
Epidiolex, manufactured by GW Pharmaceuticals, first received orphan drug status way back in November 2013. That designation specifically was Dravet syndrome, one of the severe forms of epilepsy aforementioned. That means nobody in the United States is allowed to market CBD oil for the treatment of Dravet patients for another two years.
As noted, however, the seven-year exclusion period only applies to drugs being sold to treat identical conditions. Theoretically, another company could attempt to get orphan drug approval for a rivaling CBD product as long as it was intended to treat, say, Lennox-Gastaut syndrome, another rare kind of epilepsy.
So in a clever move, just a few months later in February, GW applied for and received orphan drug designation for the same product – this time though, for Lennox-Gastaut. GW would go on to acquire orphan drug status – for the same exact drug, Epidiolex – two more times in the United States in two years. In 2017 and 2018 they hopped across the pond, where Epidiolex received orphan drug status covering two conditions it had already received orphan drug designation for just months earlier in the United States.
Regardless of what you consider fair or not, GW Pharmaceuticals sits poised to make an absolute boatload off their CBD product in profit and tax benefits. Much of the associated risk with the development of orphan drugs is the expense in research and development, and the uncertainty of just who to treat. GW Pharmaceuticals has mitigated much of this implied risk in their most recent orphan drug designations, essentially receiving tax credits and market exclusivity for a drug that has already been in existence for half a decade, and in some cases, already receiving and enjoying orphan drug status elsewhere.
It may not be free money, but the consistency of the publications shows that GW clearly likes the strategy.
The Future of CBD
Cannabidiol is having a moment right now. Companies like GW Pharmaceuticals are studying it intensely, and with FDA approval of Epidiolex still just a few months old at the time of this post, there seems to be little indication of a slowdown any time soon. Everyone wants a slice of this particular pie.
As for that gas station CBD? Probably won’t put hair back on your head. Or get rid of that weird wart on your foot. But if you have Lennox-Gastaut or Dravet syndrome, it could potentially provide you some relief. Assuming of course, that it’s genuine CBD oil. If you’re really curious, you could ask about Epidiolex.
Or, if you’re in a legal state and over 21, marijuana dispensaries are required to do strict lab testing on their products. Any CBD you might find there would also be of certified quality.
This writer, of course, could never with good conscience suggest or condone such a thing – since doing so would still be a violation of federal law.
The majority of people taking CBD are not rare disease patients, but some still claim numerous health benefits. Do you or someone you know take CBD? Do you think it has a positive effect? Does it matter if it’s a placebo if it works? Share your thoughts with Patient Worthy!