MEDICAL MARIJUANA

Epilepsy experts call for more research into medical marijuana

 
 
SO
SO

aesnet.org

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 Charlotte’s 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.

Healthcare professionals, patients, and caregivers are reminded that use of marijuana for epilepsy may not be advisable due to lack of information on safety and efficacy, and that despite 20 states legalizing the use of medical marijuana, it has not been reviewed and approved by the Food and Drug Administration for use in the treatment of any form of seizures or epilepsy.

Under federal law, every new therapy and device must go through carefully monitored studies in human volunteers before it can be marketed for regular use in patients. The studies with CBD and many other clinical studies need people with epilepsy to volunteer. To this end, those with epilepsy are in a special position to help themselves and others through participation in medical research that can lead to effective treatments.

The recent discussions surrounding medical marijuana highlight the fact that the epilepsy community desperately needs new therapies and approaches for patients with resistant or refractory seizures. We need to know more about the basic mechanisms and causes of epilepsy so that we can better match therapies to patients, and someday soon find targets for cures.

But none of these giant steps forward will be possible without robust, careful research that safeguards the health of study participants while uncovering important new findings

The actions of the people of Florida will be watched closely by the entire nation. We hope the needs of people living with epilepsy and their families will be a strong voice in this debate. However we also urge that the eagerness to find treatments will 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.

Dr. Elson So is president of the American Epilepsy Society.

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