More than six months after Kentucky lawmakers passed legislation allowing limited trials for cannabidiol epilepsy treatments, doctors have not been able to begin them.
Kosair Children’s Hospital Epilepsy Monitoring Unit Director Karen Skjei says she is waiting on FDA approval for the trials. She says one potential obstacle is if the agency requires trials with animals before testing the treatment for people.
Skjei says she would like to begin the work as soon as she can, and that many of the families she works with continue to be patient.
“Most of my families are just happy honestly that I’m working on it because UK decided not to get involved. Cincinnati isn’t doing anything,” Skjei said. “But just since, you know, it is such a challenging trial from a legal standpoint not many institutions have really wanted to take on that challenge.”
Epilepsy Foundation of Kentuckiana Co-founder Deb McGrath says not all families realized how long they would have to wait after the legislation passed this April. She knows their pain since her daughter was diagnosed with epilepsy 18 years ago.
“A number of families have been disappointed because they thought that it was going to be something that would be available immediately. But unfortunately it’s not,” McGrath said.
Another obstacle standing in Skjei’s way is sourcing the CBD for the trial.
“Right now shipping CBD across state lines is not legal so that’s going to make things a little more challenging,” she said.
Industrial hemp is a source of CBD, a non-psychoactive ingredient in cannabis, and low in THC, the compound that causes a high. Currently, hemp is only grown in small research pilot projects in Kentucky, like the one at Murray State University. Individual farmers are not yet allowed to grow the crop that the Drug Enforcement Administration considers a narcotic.
Skjei says there is currently no timeline for when trials could begin.