Patients Still Have No Access to CBD Cannabis Medicine in ‘CBD-Only’ States
Lawmakers in nearly a dozen states in 2014 enacted legislation that promised to provide patients, particularly those suffering from intractable epilepsy, the opportunity to use cannabidiol (CBD) – a nonpsychotropic plant cannabinoid recognized for its anti-convulsant properties. The problem? So far, patients in none of these states possess the ability to legally access the compound. And there is no indication that this situation is going to change any time soon.
That is because CBD remains classified as a schedule I prohibited substance under federal law. (Congressional legislation, HR 5226, to amend CBD’s status was introduced in July.) As a result, multiple federal agencies -- including the FDA, DEA, NIDA (US National Institute of Drug Abuse) and PHS (Public Health Service) -- must all sign off on any clinical investigation of the non-psychotropic cannabinoid, including state-sponsored research studies. In addition, NIDA remains the sole legal provider of CBD in any FDA-approved clinical trial.
To date, state-sponsored efforts to either gain access to NIDA’s limited CBD stocks or to license the cultivation of high-CBD plant varieties have been unsuccessful.
For example, researchers at the University of Kentucky recently acknowledged that the preliminary cost of conducting FDA-approved clinical trials on CBD, as encouraged under the state’s new law, could be as much as $10,000 per participant and that the process of designing and approving such trials “could likely take months, if not years.” That’s a far different story than the one spun by Kentucky lawmakers this past spring when both chambers unanimously passed the state’s CBD-research bill (and, in the process, elected to kill an alternative proposal seeking to outright legalize the possession and distribution of whole-plant cannabis).
It’s the same situation in Mississippi, where representatives at the University of Mississippi Medical Center recently acknowledged that it would be at least a year before researchers were able to obtain CBD products from NIDA for clinical research. "We understand the urgency and immediate need for improved treatments and are moving forward under that motivation,” UMMC representatives stated. “At the same time, our efforts are balanced by great measures of care, safety and compliance with current laws and the safety of the patients."
Similarly, in Wisconsin, Gov. Scott Walker has acknowledged that no patients in the state may legally access CBD plant products, despite the recent passage of legislation promising to make such products available. "Right now I don't know exactly how that (providing patients legal access to CBD under state law) would be done," Walker recently admitted.
In Utah, the first state this year to officially recognize CBD therapy under state law, fewer than a dozen registration cards have so far been issued to patients seeking to be a part of the nascent program. However, once registered, Utah law only provides patients with legal protection from arrest. It does not provide them with a state-specific source for cannabidiol.
In Iowa, patients qualified to use CBD under state law recently told lawmakers that their prospects of obtaining the therapeutic compound remain “light years away.” In response to citizens’ complaints, Iowa Department of Public Health administrator Deborah Thompson said that she understood patients’ frustration, but added, "[T]here are a lot of moving parts for any new program."
In the Sunshine State, local efforts to license growers of high-CBD strains of cannabis are moving at an equally sluggish pace. Under draft rules presently being contemplated by Florida regulators, only five growers of the product would be permitted. Further, in order to be considered for a license, would-be applicants must establish that they have previously operated a nursery for a minimum of 30 years. Finally, growers selected by the state to provide CBD products will have to pay a $150,000 licensing fee and post a $5 million bond before they are allowed to legally operate.
Not surprisingly then, to date, the only patients able to legally access CBD are either those who reside in states, like Colorado, that have approved for the legal use of whole-plant cannabis or those seeking the compound from pharmaceutical sources. In recent months, the US Food and Drug Administration has granted Orphan Drug Status to two specific CBD formulations: Epidiolex (developed by GW Pharmaceuticals) for the potential treatment of intractable adolescent epilepsy and a second proprietary compound, developed by Insy’s Pharmaceuticals, for the potential treatment of brain tumors. In June, the results of a preliminary trial assessing the efficacy of Epidiolex in children reported that just under half of participants obtained at least a 50 percent reduction in seizure frequency compared to baseline.
Nevertheless, it will likely be years before these pharmaceuticalized products achieve market approval and perhaps even longer before any CBD-only states create a feasible way to provide an organic alternative to those patients who desire it. In the interim, patients who might benefit from CBD therapy remain best served by advocating for laws legalizing the entire cannabis plant, not its isolated components.