A medical as well as a social breakthrough may be near – an advisory panel of the Federal Drug Administration (FDA) has unanimously recommended that Epidiolex, a preparation of pharmaceutical CBD (cannabidiol), be approved for the treatment of certain childhood seizure disorders. Why is this significant? I can think of at least 4 reasons:
- Children and their families would benefit. Some childhood seizure disorders are not responsive to current anticonvulsant medications but do respond to CBD, which could now be prescribed by physicians and obtained from pharmacies.
- A therapeutic door would be opened. Needed research could proceed on other possible medical uses for cannabis so that other cannabis-based pharmaceuticals may have an easier time being approved.
- An evidence-based decision would have been made. Despite CBD not having any addictive properties, the DEA has persisted in categorizing it as a Schedule 1 substance because it is an ingredient of marijuana. Such an illogical over-generalization would now be behind us.
- The legal ambiguity surrounding cannabis would begin to be reduced. Cannabis has been legalized in some states but is illegal at a Federal level. The Supremacy Clause of the U.S. Constitution dictates that the Federal laws overrule State laws. U.S. Congressional attempts to resolve this conflict by passing new legislation have thus far been unsuccessful.
CBD is being advertised for sale online and in stores, but there is no quality control of these products. At Kolmac, we are finding that patients have positive urine tests for THC after having consumed what purports to be CBD. Unlike CBD, THC is clearly addictive.
The FDA usually accepts the recommendation of its advisory panels, but the final decision will not be made until June 27. Political pressure cannot be ruled out from the “marijuana-is-as-bad-as-heroin” faction. Attorney General Sessions, in particular, has been outspoken about his opposition to making cannabis more available and has been threatening to close state-legalized operations. I think, however, that the long-term trend in the other direction is clear. Evidence in favor of the medical benefits is increasing, as is support for Federal legalization for recreational use. Issues related to use by adolescents and young adults, impaired driving, and increased addiction will need to be addressed, but our country appears to be ready to end cannabis prohibition as we have known it.
Contact us to learn more about pharmaceutical CBD.