July 2nd, 2018

Medical Marijuana is Being Restored as a Legitimate Medication

CBD returning to legal medical useStep by slow step, medical cannabis is being restored to its historical place as a legitimate medication: last week pharmaceutical cannabidiol or CBD (“Epidiolex”) was approved by the FDA. This could allow patients to obtain quality-regulated CBD, in contrast to the over-the-counter unregulated products currently available. Pharmaceutical grade cannabis extracts were the norm for decades until 1942 when cannabis was removed from the U.S. Pharmacopeia. Although the effort to make medical marijuana illegal began with a focus on recreational use, it was expanded to include medical use.

Despite the FDA approval, an important hurdle must be overcome before the first patient can actually take the medication. Because CBD is an ingredient of marijuana, which is classified as a Schedule I substance, it has always been treated by the DEA as a Schedule 1 substance – even though it is not addictive. A substance is placed in Schedule I if it is considered to be likely to be abused, without medical benefit, and unsafe to use. Being placed in Schedule I is what makes a substance illegal and physicians are not allowed to prescribe it. Now the DEA will the have the final say as to whether Epidiolex will continue to be classified as Schedule I or moved into another class.

The Issue of Off-Label Use for Medical Marijuana

If and when CBD actually becomes available, another issue to address will be “off-label use” – the use of an approved medication for conditions for which it has not been approved. The FDA approved CBD only for rare forms of childhood seizure disorders. Much interest exists, however, in the use of CBD for other symptoms – chronic pain being the area in which there is the strongest evidence. Given how opposed the DEA has been historically to relaxing the Schedule I restriction, it is unclear whether this routine practice of off-label use will be allowed for CBD.

Finally, there is the matter of the “entourage effect” – the idea that the full therapeutic impact of cannabis depends upon the action of multiple components of the cannabis plant, not just one of its isolated ingredients. A pharmaceutical cannabis preparation named Sativex, a 50/50 mixture of THC and CBD, is already available in 20 countries, including Canada, but not yet in the U.S. In 2014, the FDA placed in on the “fast track” for approval in the U.S. – another example of just how slow the steps can be when it comes to cannabis.

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