A few months ago, I met with a pediatric neurologist in his 4th floor laboratory/office on the Medical School campus of Washington University in Saint Louis, Missouri. I had been curious about my employer’s stance on cannabinoid medicine, and it was in this tidy, dimly lit office that I became intimately familiar with the ongoing clinical trial for Epidiolex.
Epidiolex contains purified cannabidiol (CBD), the 2nd most abundant cannabinoid molecule found within the cannabis plant. British entity GW Pharmaceuticals is currently seeking FDA approval to use this drug for the treatment of pediatric epilepsy. Although their preparation contains CBD, it contains no other active molecules from the cannabis plant.
CBD lives in a painfully confusing legal purgatory. The DEA recently re-affirmed its status it as a Schedule I controlled substance, among the ranks of heroin and PCP… more dangerous than the Schedule II drug cocaine.
Even in some prohibition states like Missouri, CBD is legal at the state level (albeit, under incredibly restrictive circumstances). Only a specific type of epileptic patients qualify, only neurologists are permitted to make recommendations for CBD, and there are only two licensed CBD producers in the entire state. Despite the throngs of parents that are desperate for their kids to have the right to try this therapy, only a handful of doctors across the state will actually provide the recommendation. None of these doctors work for my employer.
A major reason that Wash. U. neurologists have been hesitant to make these recommendations for their patients is quite simple: we were part of the nation-wide clinical trial for Epidiolex. Every child that was recommended to the state level program was one less child that could be enrolled in the clinical trial.
Fortunately, the results of this study were recently published in the New England Journal of Medicine. One hundred and twenty children with a severe form of epilepsy called Dravet’s syndrome were enrolled in the study, and those assigned to the CBD group experienced an impressive 39% reduction in seizure frequency. The number of seizures in the placebo group only dropped by 14%. All of this, from a Schedule 1 drug.
For a drug to be classified as a Schedule I substance, it should meet two criteria: 1) the drug should have the potential to be abused (it is rewarding, and people will compulsively seek it in the face of negative consequences), and 2) the drug should have no medical value.
First of all, a mountain of scientific evidence has definitively shown that CBD is physiologically incapable of being abused. It simply cannot get you high.
Re: criteria number two: The recent results of the Epidiolex clinical trial were a key missing piece of the “medical value” puzzle.
Randomized, placebo-controlled clinical trials are the gold standard for human scientific evidence. In light of these new results, the picture is irrefutably clear; cannabidiol has the potential to prevent life-threatening seizures in children (in addition to the myriad medical benefits that non-clinical trial studies have also shown).
CBD does not meet either of the criteria for a Schedule I substance. There is simply no reality-based rationale for the DEA’s arbitrary decision to demonize this incredibly valuable therapeutic tool.
The time has come to make hold the DEA accountable for it’s poor decision making. Children’s lives are at stake here; every day that CBD remains a Schedule I substance is one more day that our kids will be forced to suffer through their debilitating diseases.
Enough is enough.