The growing availability of cannabidiol (CBD) products is undeniable. There is no shortage of marketers, on the Internet and retail shelves alike, who are extolling the health benefits of what they have distilled from hemp plants. And they believe these products should be more widely accepted to treat every imaginable health condition from hair loss to epilepsy.
Recently, the Food and Drug Administration conducted a public hearing to examine this issue. It reinforced my longstanding belief — as a practicing neurologist with 25 years specializing in treating patients suffering from epilepsy — that access to products containing CBD must be restricted to those that have received FDA approval. These products, after rigorous testing and review, should be made available only to patients under physician supervision. The notion of buying “miracle” cannabidiol-based treatments over the counter should be ended firmly and swiftly.
For those of us who treat epilepsy patients, our greatest fear goes by the acronym SUDEP: Sudden Unexpected Death in Epilepsy. Discovering a healthy loved one, without warning, dead in their bed is a stark reality for families traumatized by SUDEP. And the risk of this occurring is heightened when patients are exposed to psychoactive drugs.
CBD treatments are the latest and most popular fad that epilepsy patients and their loved ones are reaching out to try in hope and desperation. They have heard about CBD on TV, in social media, from well-meaning friends or relatives or even at the gym, and they wonder, what could be the harm of trying it?
The potential harm is considerable. Throughout my career, I have urged my epilepsy patients to avoid over-the-counter treatments, supplements, formulas and vitamins. The fact that these elixirs are billed as “all natural” is irrelevant. Most potent and harmful drugs are initially derived from natural ingredients. Patients will show me the label and point to supposedly safe ingredients, and I explain to them that the problem is what’s NOT on the label — harmful components that could exacerbate seizures in a person with epilepsy.
Further, there is no requirement for a manufacturer to be truthful on a label unless the product is regulated by the FDA — and it’s worth noting that an FDA-approved treatment requires a prescription. With the current wave of CBD mania, I’ve been sharing this cautionary note with patients several times a day.
The problem with unregulated products is not new, but the complications connected with CBD products are. In an unregulated cannabidiol product, the unknown, unquantified ingredients often include tetrayhydrocannabinol (THC), the psychoactive drug that gives cannabis users a “high.” And, the potential for tragedy is amplified because psychoactive drugs increase the likelihood of SUDEP.
On the bright side, CBD development does hold promise for epilepsy patients. Epileptologists now believe that purified, highly concentrated CBD oil is beneficial in some patients with certain epilepsy syndromes. We know this because this particular substance went through several FDA clinical trials and ultimately received agency approval for one treatment. Thanks to this research and data, as well as necessary inspections to ensure the integrity of the treatment, my patients and I can make informed decisions about this particular drug.
We cannot, by contrast, make informed decisions about CBD products sold online and in retail stores with contents that can contain harmful cannabinoids like THC and potentially other toxins, such as pesticides and fertilizers.
SUDEP is very real. It will strike about one in every 1,000 adults with epilepsy per year. And for those with poorly controlled seizures, the risk rises to one in 100. Taking a flawed substance in the belief it will control seizures heightens the SUDEP risk. That alone is the reason to regulate these products.
As the FDA considers a regulatory pathway for CBD products, they should close their ears to the those who would make every fly-by-night product available to all, and instead remember that every supposed health product that is not regulated by the FDA is potentially deadly. This is particularly the case for individuals who are already fighting for their health and their lives.
SOURCE: Opinion by Azrenna B. Thomas is a board certified neurologist and epileptologist, practicing for 25 years in San Antonio. From Statesman.com July 8, 2019