Earlier this year, legislators passed a new law allowing children who suffer severe forms of epilepsy to use an experimental oil extracted from marijuana.
But state officials now say complications could prevent those children’s families from buying the very oil they need.
The problems were laid out in front of a special legislative committee studying possible medical marijuana use in South Carolina. During a meeting Wednesday, committee members learned more about a planned Medical University of South Carolina clinical trial that will test the drug Epidolex on about 5-10 patients who suffer from Davet Syndrome. The trial will test the British drug’s effectiveness in patients suffering from the severe form of epilepsy. Similar tests are already underway in other states, including Georgia. MUSC hopes to begin the study next year.
Epidiolex is a form of cannabidiol oil (also known as “CBD oil”) that is extracted from cannabis. It does not contain plant’s chemicals that create the sensation of feeling “high.”
But it’s not clear if South Carolinians would be able to use CBD oils for treatment outside of the MUSC research. Dr. Wendy Bell, a toxicologist at the State Law Enforcement Division who serves on the committee, said law enforcement officials still have concerns about the chemical. At this point, Bell said SLED opposes CBD oil being produced in South Carolina until it is approved by the Food and Drug Administration.
“The FDA approval process assures that they are getting a certain quality of product at a certain concentration,” she told the committee. “That stamp of approval is very important.”
But since federal law bars schedule one substances like CBD oil from being sold across state lines, that makes things difficult for families seeking to buy the chemical for treatment.
MUSC President David Cole said any FDA approval of the drug could hinge on how well it does in the clinical trials. He predicted it would be at least two or three years before the FDA allowed the oil to be available for prescription nationally, possibly longer.
But some parents of children suffering from the seizures say that is far too long.
“My daughter… probably doesn’t have two years to wait to wait for a Epidiolex trial,” Janel Ralph told the committee, saying her five-year-old daughter Harmony has a brain disorder known as lissencephaly. Since the illness is not epilepsy-related, Harmony is not eligible for the MUSC clinical trial.
“If we have these laws, shouldn’t we be able to access medicine for them now?” Ralph asked.
State Sen. Tom Davis, a Beaufort Republican who helped write the new law and chairs the committee, was frustrated at the apparent inconsistency in allowing children to take the oil, without giving them a way to access it. “In my mind, implicit in (the law) is the right to grow and manufacture it,” he said during Wednesday’s meeting. “It would be nonsensical to legalize possession and use of the substance and not allow it to be created.”
He also questioned if there were truly any safety concerns with the oil, since other states have legalized it for more than 10 years.
But Bell said SLED was also concerned that any marijuana used to make CBD oil could easily be diverted for illegal recreational use. She noted Colorado had similar problems when it legalized medical marijuana in 2000.