The World Health Organization (WHO) Expert Committee of Drug Dependence (ECDD) held their 40th meeting in Geneva from the 4th-7th of June 2018. This session was dedicated to a critical review of Cannabidiol (CBD), a non-psychoactive cannabis cannabinoid, and several pre-reviews outlining the epidemiology, toxicology, and efficacy of the cannabis plant and resin, extracts and tinctures, tetrahydrocannabinol (THC), and THC isomers, conducted by Americans for Safe Access (ASA) and the International Medical Cannabis Patients Coalition (IMCPC).
In simple terms, the WHO is revisiting their stance on the safety and efficacy of cannabis as medicine; good news for countless legal, medical, and academic reasons.
The critical review on CBD follows a November 2017 pre-review that concluded there is not enough evidence to justify the scheduling of CBD. Under the Controlled Substances Act, if a drug is found to have the potential for abuse, it is placed on a drug schedule. The Schedule level (from I through V, with I being the strictest) is then determined by assessing its medical benefits and relative potential for abuse. The stricter the schedule, the harsher the legal penalties, the more limited the supply, and the more difficult it is to conduct research on the drug in question.
The bottom line of the critical review revealed CBD is generally well tolerated and provides many therapeutic benefits without the “high,” and few to no side effects. The review also concluded there is no evidence of recreational use or any public health issues associated with use of pure CBD. The benefits of CBD outlined in the review include antiepileptic properties for seizure disorders (the most well-researched effect of CBD), as well as anti-inflammatory, analgesic, neuroprotective, hypoxia-ischemia, antipsychotic, anti-asthmatic, anxiolytic, and anti-tumor properties. Most recently, human studies have reported anti-autoimmune properties in the development of graft vs host disease after cell transplant, as well as efficacy in reducing some positive symptoms of schizophrenia. Lastly, they mention a systematic review of the limited, yet emerging data on CBD use for drug addiction treatment.
The ECDD plays a major role in global drug regulations. They are responsible for assessing the health risks and medical benefits of psychoactive substances using several criteria: evidence of abuse potential, actual levels of abuse or evidence of likelihood, and therapeutic applications. Based on their assessments, the WHO presents their recommendation for the placement, removal, or Schedule change of the drug to the UN Secretary General and Control Narcotic Board (CND), who ultimately decide whether to place the drug under international control.
In the 1950’s, the ECCD approved the categorization of cannabis as a Schedule I drug, defined as having “no or few therapeutic effects,” and being “particularly liable to abuse and to provide ill effects.” To give this some context, other Schedule I substances include heroin, LSD, ecstasy, and peyote, while cocaine, methamphetamines, methadone, oxycodone, and others are considered Schedule II – meaning cannabis is considered more dangerous than cocaine and opiates.
Although the WHO is responsible for conducting risk assessments for all drugs with potential for dependence or abuse, this is the first formal scientific review of cannabis. Despite a lack of evidence and review, their recommendation was adopted at the 1961 Single Convention on Narcotic Drugs and this is the first time the status of cannabis has been reassessed since.
What this could mean for patient access:
The de-scheduling of CBD has many implications for the market. The current classification poses obstacles in terms of the product and marketing. For example, many CBD products are being produced from industrial hemp, rather than the cannabis plant – a legal, but much less effective, alternative. Hemp-derived CBD faces less legal restriction because it does not contain THC; however, CBD has been found to be more effective when used in conjunction with low doses of THC, which can be found in cannabis-derived CBD (typically less than 0.3%).
Additionally, due to its legal status, CBD products are not subject to the same standards as pharmaceutical products, which has resulted in a wave of mislabeled products – one study of 84 CBD products found almost 70% of them to be mislabeled in terms of the amount of CBD and 21% contained THC, some with concentrations up to 6.45 milligrams/milliliter, enough to intoxicate a child.
Also, because cannabis is still defined as having no therapeutic effects, suppliers cannot mention medical benefits of CBD in their product promotion. Once de-scheduled, CBD products would be subject to the same laws and regulations as other medications or food supplements, ensuring products are authentic, safe, properly labeled, etc. While there is little concern for overdose – chronically administered and high doses of up to 1500 milligrams of CBD have been well tolerated in humans – the regulation of CBD would ensure uncontaminated, clearly-labeled products that provide patients with proper therapeutic doses to achieve the desired medical benefits.
The bigger picture:
Other difficulties are posed in terms of import/export regulations and local commerce. In the UK, for example, it is legal to import CBD products from the U.S. and EU countries, but local companies are prohibited from producing the same products. These and many other challenges could be solved by the de-scheduling of CBD.
Contrary to several misleading reports, the review’s conclusions apply to CBD specifically, and not to cannabis overall. Without doubt, this is a big step forward for de-scheduling. The critical review of THC is scheduled to be presented at another meeting of the ECDD in November 2018. From these reviews, the WHO will make recommendations regarding any changes to the scheduling of cannabis that will be voted upon at the UN’s 62nd session of the Commission of Narcotic Drugs in Vienna in March 2019.