Area doctor gets FDA approval for medical marijuana trial

By Katie Demeria

About eight months ago, three mothers approached Dr. Paul Lyons seeking his help.

All three have children who suffer from intense seizures and they wanted to learn about the use of medical marijuana to treat epilepsy. Their request piqued his interest, and now Lyons, who works with Winchester Medical Center, has approval from the Food and Drug Administration to research the use of cannabis oil in the treatment of two epileptic children.

The drug does not have the properties of the herb marijuana that causes euphoria, he clarified, and it does not need to be smoked or inhaled.

“It’s a great opportunity,” he said. “Obviously it’s a small trial, with only two subjects, and it’s hard to generalize it. Nonetheless, I want to demonstrate that it can be done safely, appropriately, and in a community setting hospital without it being reckless or inappropriate.

“I hope to offer this as proof: it’s a feasible possibility in the state of Virginia.”

Refractory epilepsy, which both of the children have, is a form in which seizures persist despite attempted treatment with two appropriate medications given at appropriate doses.

If an epileptic individual is not helped by the first two medications, the chances of finding a medication that works is reduced to between 5 and 8 percent, Lyons said.

“Despite all available treatments and despite 102 years of medical research, we still have a third of patients with refractory epilepsy. That’s why we need new drugs,” Lyons said.

The two patients, a 6-year-old girl from the Northern Shenandoah Valley area and a 10-year-old boy from Newport News, have both failed multiple medications.

The boy suffered a devastating infection of the brain that caused epilepsy in early childhood, Lyons said. The boy has prolonged, daily seizures.

“And equally as devastating is the change in personality, the effect on learning, personality, sense of humor, mood — and he’s not a candidate for epilepsy surgery because the seizures start in multiple areas,” Lyons said. “He was the impetus behind the application.”

Lyons had to go through an application process with the FDA and agree to work with GW Pharmaceuticals, a company in the United Kingdom that produces an FDA-approved cannabis drug.

He said he is hoping to begin working with the patients by the end of the summer.

The results of the research could vary: Lyons stressed that the use of cannabinoids has not yet been proven to benefit patients with epilepsy.

“I’ve clarified everything with them. We don’t know what the effects will be — they may be positive, negative, or neutral,” he said. “But certainly, they’re being offered an option for pharmaceutical grade cannabinoids that could help.”

When the research is completed, Lyons plans to publish his work, sharing the results with his colleagues, and “just as importantly, share them with the general community and the state legislature.”

“At the very least, one of the jobs of doctors — and not just doctors, but the whole health care community — is to give families hope,” Lyons said. “I think this is something different, something that will provide hope for tomorrow. That’s why we do medical research in the first place.”

Contact staff writer Katie Demeria at 540-465-5137 ext. 155, or kdemeria@nvdaily.com