Earlier this year a British company called GW Pharma made huge headlines when they gained FDA approval here in the US on their cannabis derived CBD anti-seizure medication known as Epidiolex.
This marked the first time that the federal government had acknowledged the commonly known medicinal value of cannabis, and had everyone wondering what it meant for the future of not just CBD, but for the whole plant.
The FDA’s ruling was then moved to the DEA, who in June of this year was given 90 days to decide how to handle the scheduling of Epidiolex, CBD itself, and cannabis as a whole.
Well, we finally got their answer this week and it led to a lot of misleading headlines about exactly what it meant.
In a statement on Friday, the DEA announced that it was officially placing “FDA-approved” CBD medications on Schedule V of the Controlled Substances Act. Schedule V is the least restrictive classification and is granted to drugs that have a proven medicinal value and a low risk of abuse.
Cannabis and non-FDA-approved cannabis derived CBD products remain as Schedule I drugs. Schedule I is reserved for drugs that the federal government has deemed have no medicinal value and carry a high risk of abuse.
So that is the government’s incredible lack of logic on full display: Epidiolex is medicine, but the plant that it is derived from is not.
For now, Epidiolex is the only FDA approved CBD medication, but with the FDA and DEA ruling, surely the race is on for Big Pharma to exploit the plant enough to saturate Schedule V with stripped down mids.
GW Pharma plans to have Epidiolex officially on the market in six weeks.
The controversial anti-seizure drug has been in the spotlight since first getting the nod from the FDA. Intended for use by patients suffering from rare and intractable forms of epilepsy, red flags got raised when the company said that annual treatment costs would be well over $30,000.
More concern came when the FDA released the known side effects from the clinical trials of Epidiolex. Patients reported bouts with insomnia, rashes and infections, early indicators of liver disease, and more conditions not normally associated with the full spectrum oils found on hundreds of dispensary shelves at the state level.
Some patients experienced a condition called epilepticus tremens, in which the frequency and severity of their seizures increased when trying to get off of Epidiolex when it did not produce the results they were seeking.
Overall, the clinical trials must have shown that Epidiolex was more beneficial than a placebo in preventing seizures for enough patients to convince the FDA to give its approval.
So, if this week’s news was a blessing for at least one family out there then it is a small step in the right direction. But, from start to finish, the saga behind Epidiolex has proven that despite the green wave of marijuana reform sweeping the nation, the US federal government still has no interest in recognizing the many medical benefits that come from the entire cannabis plant.
The fight continues…