Utah’s move to introduce legislation that will allow consumers to buy cannabis oils (CBD) and other marijuana derivative products is not based on solid research.
Our hearts are with families and their children who live with severe forms of epilepsy like Dravet Syndrome, and we applaud the efforts of those leading the initiative to find remedies. Yet, as physicians and researchers specializing in treatment of this challenging spectrum of disorders, we must ensure that the professional and lay community does not make treatment decisions that are not based in sound research and science.
While there are positive anecdotal reports from the strain of CBD known as Charlotte’s Web, robust scientific evidence for the use of any type of marijuana for treatment of epilepsy is lacking. The lack of information does not mean that marijuana is ineffective for epilepsy. It simply means that we do not know if marijuana is effective, and just as important, if it is safe.
Little is known about the long term effects of using CBD or any marijuana derivative in infants and children on memory, learning and behavior. This is of particular concern because both clinical data in adolescents and adults and laboratory data in animals demonstrate that there are potential negative effects of marijuana on critical functions like learning. Such safety concerns coupled with a lack of evidence of efficacy in controlled studies means that we do not know if the benefits of marijuana for treatment of seizures outweigh the risks.
Several members of the American Epilepsy Society are conducting clinical trials of CBD. There are several steps in a clinical trial and we need to wait to draw conclusions until there has been a trial with a control group or a placebo-controlled trial. The preliminary steps underway now will not have a placebo group and will be used for dose finding, tolerability and to understand how human bodies absorb and process the drug.
If these initial safety studies are encouraging, then further controlled studies will be needed to determine if CBD is effective in the treatment of seizures and in which patient populations (i.e., what ages and types of epilepsy).
These studies are critical, as the pathway to finding new drugs and treatments is full of treatments once thought to be the "miracle cure" that were rejected after the rigors of a clinical trial. These studies are especially important in a condition like epilepsy that has a very variable course. Sometimes significant improvement can actually be a result of unpredictable ebb and flow of the disease.
Treatments cannot advance without clinical trials. Clinical trials are necessary to test the safety and effectiveness of new therapies and to develop better ways of using known treatments.
The American Epilepsy Society is supportive of well-designed clinical research to determine the safety and efficacy of marijuana in the treatment of epilepsy. We urge the entire community of medical professionals, patients, families and regulators to focus their efforts on getting accurate information and allowing proper research to be done.
States around the country are having the same debate as the one in Utah. We hope that the needs of people living with epilepsy and their families will continue to be central to the debate. However we also urge that eagerness to find treatments not overshadow the need to conduct rigorous research and testing. Together as an epilepsy community we must take this step to find the answers for people living with these severe forms of epilepsy.
Elson So, M.D., is president of the American Epilepsy Society.
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