In many communities, it’s impossible to walk down a street without seeing signs promoting cannabinoid (CBD) products. Yet we know very little about the safety and efficacy of CBD products. Many of these substances lack instructions developed by qualified experts on proper use and even fewer provide information on how they may interact with other medications, or how they may affect other disease states.
We need and deserve better.
My interest in this topic is not a theoretical one. My family has seen the benefits firsthand of the only CBD prescription medication approved by the Food and Drug Administration, but not before we went through an upsetting process — considering untested, unproven, unregulated medications with all of the significant risks that accompany their use.
I have insight into these issues others may not. My infant daughter has a rare disease that resulted in her having as many as 25 seizures a day. My wife and I did everything we could. After trying a host of seizure medications that were unsuccessful, we were facing a major surgery that would require operation on our daughter’s brain. Physicians were hoping for a 50 percent reduction in seizures — and our daughter would lose functional use of half of her body in order to accomplish this.
Desperate enough to consider driving to a dispensary in Colorado for CBD oil of essentially unknown origin, containing untested and unverified ingredients, with the hope of minimal side effects. We wouldn’t know for sure if we were helping our daughter or hurting her, but we were running out of options and time.
Fortunately, we soon learned of the single FDA-approved CBD medication. Since taking it, our daughter has not had any seizures, has been able to stop taking six other medications, and is now reaching new developmental milestones.
But we were prepared to put ourselves in the midst of the wild west atmosphere that defines the current sales and marketing of CBD products. And we understand the desperation of others willing to do the same.
This is becoming an increasingly serious issue and we need expedited regulatory action to keep our families and communities safe. My family is not alone. We live in a world in which there are 7,000 conditions categorized as rare diseases affecting, cumulatively, more than 30 million Americans. Only 5% of these diseases have available treatments.
At the same time, sellers of CBD products are making bold claims that their cannabidiol can cure all kinds of physical illnesses and psychological conditions. A population desperately seeking answers intersecting with merchants promising them haphazardly is unsettling. This will not end well if those products are ineffective or, worse yet, contain toxic ingredients or impurities.
The FDA can help us. The FDA has the ability to bring some much-needed sanity and safety to this environment. Creating a clear regulatory framework in which product manufacturers can come forward to demonstrate efficacy and safety — while showing conclusively that their claims have a scientific basis with FDA approval — would create more options for health care professionals and consumers than the single CBD-based drug that is currently available.
By opening up this pathway, the FDA could then take a tough approach addressing products that have not sought the agency’s approval and restrict their unfounded marketing claims. Consumers need and deserve this clear line of demarcation between the legitimate and the potentially dangerous. This should not be delayed.
It’s the nature of government agencies to move at a slow, cautious pace on regulatory matters. The CBD marketplace, though, is forcing the FDA’s hand to move more aggressively and accelerate progress toward approving and labeling CBD products that are proven safe and effective. An increasing number of Americans are desperately trying to navigate their way through an unknown environment without a road map. We shouldn’t force them to roll the dice and depend on guesswork about products are safe and which may be either ineffective or even harmful.
By devoting more resources to clinical trials, the FDA can get more effective CBD products into the marketplace and be better positioned to crack down on the less-well-intentioned players who are peddling their own versions of cannabis snake oil. Families like mine, who need treatments will have access to the medications they need.
I know firsthand that a CBD product can make a profound difference in health and lives. My daughter is living proof of that. More families should experience these same benefits, but that won’t happen until a clearer, safer pathway toward these innovative medicines becomes reality.
Werline is a pharmacist in San Antonio. He provided testimony during the May 2019 hearing with FDA, sharing his perspective as a pharmacist and parent affected by CBD products. He wrote this for InsideSources.com.