As the Florida Legislature and citizens debate the issues of medical marijuana, our hearts are with the families struggling to find answers for their children who live with severe forms of epilepsy like Dravet Syndrome.
Yet, as physicians and researchers specializing in the treatment of this challenging spectrum of disorders we must ensure that our professional and lay community does not make treatment decisions that are not based in sound research and science.
While there are a number of anecdotal reports of positive outcomes from a particular strain of marijuana used for treating patients with epilepsy, robust scientific evidence for the use of marijuana for treatment of epilepsy is lacking. The lack of information does not mean that marijuana is ineffective for epilepsy. It merely means that we do not know if marijuana is a safe and efficacious treatment for epilepsy.
In addition, little is known about the long term effects of using marijuana in infants and children on memory, learning and behavior. This is of particular concern because of both clinical data in adolescents and adults and laboratory data in animals demonstrating potential negative effects of marijuana and its derivatives on their critical neurological functions.
Such safety concerns coupled with a lack of evidence of efficacy in controlled studies result in a risk/benefit ratio that does not yet support use of marijuana for treatment of seizures.
The form of marijuana in the spotlight is known as Charlottes Web from a plant that is thought to contain relatively little tetrahydrocannabinol, or THC, the primary component that produces a high. Instead, the strain has high amounts of another compound cannabidiol, or CBD. This is not smoked but used in an oil form.
Several members of the American Epilepsy Society are now conducting clinical trials of CBD including one developed by a British drug company. 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 establish an understanding of 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 (ie., 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, and 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.
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Epilepsy experts call for more research into medical marijuana