Epidiolex helping kids with epilepsy

This week’s annual meeting of the American Epilepsy Society has included the presentation and discussion of several papers about Epidiolex, a purified CBD oil produced by GW Pharmaceuticals.

Epidiolex, which is now in clinical trials, is widely considered among healthcare experts to be the safer experimental option for treating forms of severe childhood epilepsy than the non-purified CBD oils typically found in medical marijuana dispensaries, such as “Charlotte’s Web.”

Until a full clinical trial with a placebo-controlled element is complete, it’s impossible to tell if Epidiolex is having a real effect on epilepsy — but early results are promising, said Dr. Orin Devinsky, a neurologist at the New York University Langone Medical Center and lead author on the largest study of Epidiolex being presented at the epilepsy society meeting in Philadelphia.

Devinsky’s study started last year with 313 children from 16 different epilepsy centers nationwide. Over a three-month trial, 16 percent of the participants withdrew because the cannabidiol was either ineffective or had adverse side-effects. However, of the 261 patients who continued in the trial experienced reductions in severe seizures by almost half. Many continued experiencing benefits after the trial ended, including 9 percent of all patients and 13 percent of those with Dravet syndrome who reported being seizure-free — many for the first time in their lives.

The American Epilepsy Society fully supports the clinical trials being conducted by GW Pharmaceuticals and another trial set to begin with another pharmaceutical version of CBD that has been developed by INSYS Therapeutics.

However, the society warns against using CBD products that states have legalized because they are not regulated for purity or uniformity. Parents using marijuana-dispensary CBD report variability in seizure control — and use of a substance that sometimes does not work at all.

“Epilepsy specialists in Colorado have been at the bedside of children having severe dystonic reactions and other movement disorders, developmental regression, intractable vomiting and worsening seizures that can be so severe they have to put the child into a coma to get the seizures to stop,” Dr. Amy Brooks-Kayal, president of the society stated in a July 13, 2015, letter to Idaho Gov. Butch Otter.

Whether these distressing events are caused by so-called “artisanal” CBD products themselves or by the contaminants they may contain no one can say, she explained. The society encourages states to fund research instead. Currently, a few states, including Georgia, Idaho and Alabama, have FDA-expanded-access programs.

“States can do what Georgia did last year,” said Sue Rusche, executive director of National Families in Action. “They can educate the governor and legislature about the FDA’s expanded access program and get a statewide effort going in their states. Hopefully, Epidiolex will win FDA approval, putting an end to Charlotte’s Web Oil and other so-called ‘low-THC’ CBD oils.”

Christine Tatum is an veteran, award-winning journalist — and Dr. T’s wife. She is also a contributing member of The (Colorado Springs) Gazette’s Editorial Board and co-author of the perspective series, “Clearing The Haze.”