There was a great deal of celebrating in certain circles on Monday, when British pharmaceutical giant GW Pharmaceuticals announced that it had received FDA approval for Epidiolex, which is derived from cannabis and is used to treat two rare forms of pediatric epilepsy, Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). SeekingAlpha reports that children suffering from both kinds of epilepsy who treated with Epidiolex showed reduced seizures when compared to those treated with a placebo. And while I wouldn't be surprised if there were at least one member of the current administration who is pro-pediatric epilepsy ("kids need more exercise, and seizures are a great workout"), this was taken as a very positive development by many. Not by all, which we will come back to shortly.
It's the first time in history that FDA has approved a cannabis-derived drug, which is a huge deal. As Stat reports:
Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.Meaning the drug may be available as early as this fall. The report by Stat goes on to add that analysts predict the drug might be used to treat forms of epilepsy other than DS and LGS. It's from a strain of cannabis bred by GW Pharmaceuticals to have high levels of CBD and low levels of THC. There's also potential that insurers could pay for Epidiolex treatment. So why isn't the celebration of this news universal?
GW Pharmaceuticals’ U.S. commercial business, Greenwich Biosciences, began quietly lobbying to change states’ legal definition of marijuana, beginning in 2017 with proposals in Nebraska and South Dakota. Some worried the company’s attempt to ensure its product could be legally prescribed and sold by pharmacies would have a side effect: curtailing medical marijuana programs already operating in more than two dozen states. The proposals generally sought to remove CBD from states’ legal definition of marijuana, allowing it to be prescribed by doctors and supplied by pharmacies. But the change only applies to products that have FDA approval. Neither Nebraska nor South Dakota allows medical use of marijuana, and activists accused the company of trying to shut down future access to products containing cannabidiol but lacking FDA approval.No doubt GW wants to make sure their product is available, as the drug is expected to make over a billion dollars. And remember it's made from a propriatary strain of cannabis owned by GW, which will most likely be leveraged into additional profits as well.
Denver-based attorney Christian Sederberg, who worked on the GW Pharmaceuticals-backed legislation in Colorado on behalf of the marijuana industry, said all forms of marijuana can exist together.While Sederberg may be right, the concerns expressed by those who have already been using CBD medically have validity. Many of these people have been treating themselves, or children, with formulations that contain some amount of THC, as CBD is an entourage cannabinoid that, for many, works best in conjunction with THC. They may not feel comfortable switching to a CBD-only treatment plan, and definitely don't want their access restricted to a single treatment option.
“The future of the industry is showing itself here,” Sederberg said. “There’s going to be the pharmaceutical lane, the nutraceutical (food-as-medicine) lane, the adult-use lane. This shows how that’s all coming together.”
While everyone knows that multi-national pharmaceutical companies only want the best for us all, and invariably have 100-percent altruistic intentions, it's important to protect the rights of patients to treat their health with whatever plant-based formulations they find best meet their needs. We'll see where this goes.