Years ago, I was a leukemia patient and bone marrow transplant recipient confronting an extremely difficult decision: Do I continue down an uncontrolled, life-threatening spiral caused by “wasting syndrome” (persistent and potentially fatal weight loss), or do I try an unproven, unregulated, illegal and potentially toxic approach — cannabis?
My oncologist was reluctant to make a recommendation due to the lack of credible information, not to mention safety and legal concerns. But, as a scientist with decades of experience at both research-based and generic pharmaceutical companies, I chose to roll the dice.
I opted to try “medical” cannabis based on anecdotal reports from my hematologist, colleagues and friends, despite my anxiety over inhaling an — at the time — unregulated substance with no evidence-based science to support its use, nor assurances against harmful contaminants. I was fortunate then, and subsequently opted to serve as commissioner on the Maryland Medical Cannabis Commission, in an effort to ensure no one else would have to take such a gamble in deciding on a treatment.
Both my career and my experience as a patient have given me a unique perspective as to how cannabis and cannabis-derived products, like cannabidiol (CBD), should be regulated. CBD, a cannabis plant extract that doesn’t cause intoxication, is now being touted as a potential fix for everything from anxiety to inflammation. It’s added to lotions, oils and gummies and even sold as an additive for your coffee.
But regulators are beginning to recognize the dangers inherent in our current “anything goes” environment of unregulated CBD products: The Food and Drug Administration held a day-long hearing on the issue last week.
A 2017 paper in the Journal of the American Medical Association highlighted the lack of quality and consistency in CBD products, which poses risks to consumers. Manufacturing standardization in compliance with good manufacturing practice is one of many critical needs. Experts are calling for the creation of a national standard for CBD, while others focus on label standardization and the need to incorporate into the CBD category rules that currently regulate dietary supplements, foods and cosmetics. I strongly agree with these experts.
Much of the data we rely on today for safety, efficacy, bioavailability and human abuse potential was generated by traditional drug development companies that committed the time and expense required to conduct robust pre-clinical and clinical trials. Society must continue to support such traditional research protocols for medical products.
I would like to suggest a “three-lane highway” approach that would enable the FDA to work within its existing structure to create a regulatory framework for CBD products.
First, the “slow lane”: Purified, high-concentration products are defined as drugs and are required to undergo robust clinical trials to demonstrate safety and efficacy in ways that meet the agency’s standards.
Next, the “middle lane”: Lower-concentration oral dosage forms are regulated as dietary ingredients or foods.
Lastly, the “fast lane”: Topical dosage forms are regulated as cosmetics.
While all patients deserve the ability to make informed decisions through conversations with their physicians, the most vulnerable patients with serious illnesses and conditions require assurances that the safety and effectiveness of the medical products they take have been established. This can be achieved through the FDA’s stringent regulatory process.
Perhaps the best incentive for the continuance of traditional research was removing from the Controlled Substances Act both hemp and hemp-derivatives, which contains less than 0.3% tetrahydrocannabinol, or THC, the intoxicating substance that induces marijuana’s psychological effects.
A United State Pharmacopeia (USP) monograph for CBD would ensure accurate product testing for THC concentrations and all of the other issues. Additional incentives can be built into rules and laws as exemplified in the 1984 Hatch-Waxman Act, which created exclusive marketing periods for product innovators.
Finally, another very important incentive could be giving automatic Fast Track status to all cannabis-based investigational products or treat them as if they had “breakthrough therapy” designation, which would expedite their development and review if they show promise and are intended to treat a serious condition, among other criteria.
The FDA has a unique role to play at this moment in history, and I recommend the agency follow words that have inspired me throughout my career and my life: listen, anticipate, guide.
We don’t need 50 different sets of state regulations for CBD products. But we do need to protect patients against having to take the risks that I did in terms of safety, efficacy, potency (dosage and concentration), product integrity and the myriad unknowns that exist with today’s unregulated CBD products.
Today’s patients should not be forced to leave the comfort and relative safety of the existing medical system in order to seek potential relief, as I once was.
Debby Miran is a former member of the Maryland Medical Cannabis Commission. This was written for the Baltimore Sun.
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