Tue May 27, 2014
Medical Cannabis Oil Will Take a While to Get to Kentucky—Despite Legislature's Intentions
A new law that would allow state university research hospitals to study and prescribe medical cannabis oil is hitting a few snags on its road to implementation.
Signed into law by Gov. Steve Beshear last month, the Kentucky General Assembly unanimously passed SB 124 in both the House and Senate following some of the most impassioned testimony of the entire 2014 session; specifically, the testimonies of Kentucky families with children suffering from chronic seizures. They say traditional pharmaceutical medications aren't working.
University of Louisville researchers say many obstacles remain between the drug—which a growing body of research suggests alleviates the symptoms of epilepsy and other neurological ailments—and ailing prospective Kentucky patients who might benefit from the oil. That's despite the intent of the legislation.
"The reality of it was just as disappointing to us," said Chris Shafer, an epilepsiologist at the University of Louisville who is helping create a cannabis oil program there. "Once this was passed, yes it was legal to do so, but there were many other things that needed to be in place before we proceed. We're working really hard, but it's going to take some time."
Shafer and his colleague, Karen Skjei, an assistant professor at UofL and director of Louisville's Kosair Children's Hospital's pediatric epilepsy monitoring unit, say bureaucratic red tape, a lack of funding for a possible clinical trial, no identified oil manufacturer located in the state and a federal prohibition on the oil itself represent multiple kinks to iron out.
“It’s not available anywhere in the state," Skjei said. "You can’t bring it in across state lines. So at this point there’s no way for patients to get it.”
The oil contains a chemical compound called cannabidiol, which anecdotal evidence posits can treat seizures like those experienced by Eli, the son of Hyden resident Rita Wooton, who has multiple seizures daily. She was one of many parents who lobbied the legislature to pass the bill.
"I'm frustrated with it. I'm really aggravated by it," Wooton said. "Because I'm sure that when everyone said down and started discussing this bill and coming up with a solution to help these epileptic kids and adults ... I guess no one ever thought about that."
The oil can be processed from either hemp or marijuana, but the new Kentucky law only permits the oil to be derived from hemp. But the federal agencies such as the Drug Enforcement Administration don't distinguish between the psychoactive, THC-containing version of cannabis known as marijuana and its benign cousin, hemp. So the drug remains illegal to transport the oil from other states such as Colorado, where it is also legal.
Because it's illegal to import the drug across state lines, Skjei and Shafer say the only alternatives are to lure a manufacturer of the oil to the state, or purchase the oil as part of a program approved by the federal Food and Drug Administration. The latter option, Skjei says, will require funding.
The bill was originally sponsored by outgoing Republican state Sen. Julie Denton, who is currently seeking a seat on the Louisville's Metro Council. Skjei says that of the bill's myriad original cosponsors, only Denton has recommended possible funding sources for a possible FDA program, but Skjei said none of them have panned out.
But Shafer says they have spoken with multiple drug manufacturers and marketers since the bill was signed into law, and they are close to working out a deal with a California-based company called Pacific Eclipse to secure funding for an FDA trial. If that happens, Shafer said that the timeline for getting the drug into the hands of prospective patients like Eli Wooton won't "be as long of a lag as we might think, maybe three or four months before it's actually up and going."
(Image via Shutterstock)