Four Idaho Kids Have Qualified To Take Marijuana-Derived Epilepsy Drug

Robert Celt

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Four Idaho children are now taking a drug derived from marijuana to treat severe epilepsy under a limited state program, Idaho lawmakers learned Monday, and 18 more kids are being screened for the program.

Gov. Butch Otter in April issued an executive order to launch an "expanded access" program to the British drug Epidiolex, after vetoing legislation that would have allowed the use of cannabidiol, a low-THC oil extracted from cannabis, to be used legally in Idaho to treat children with severe seizure disorders. The measure had passed both houses after long and emotional hearings, but Otter's Office of Drug Policy and the Idaho State Police decried it as a step toward legalizing medical marijuana.

Epidiolex is a purified oil made from the marijuana plant that contains no THC, the component that causes intoxication. Clinical trials are underway to use it to treat children with severe epilepsy, and the expanded access program allows other kids not in the trials to receive the drug.

The director of Idaho's state Division of Public Health, Elke Shaw-Tulloch, told the Legislature's joint budget committee Monday that Idaho has been awarded 25 slots in the expanded-access program, which allows drugs currently in clinical trials to be dispensed to others not in the trials on a limited basis. Now, "after many, many months of working with the Drug Enforcement Administration, the Food and Drug Administration, the pharmaceutical company and our contractor, we have had many families coming to us trying to get their children enrolled," she said.

"We finally have four kids who are actively taking Epidiolex as of this week," she said.

If Idaho has more demand than the 25 slots allow for, she said, it will apply for more slots.

Idaho is now alone among all its surrounding states in banning any form of marijuana use, for medical or other purposes. Wyoming recently legalized the supervised use of cannabidiol oil, also called CBD oil, to treat intractable epilepsy or seizure disorders; Utah did the same in 2014. In 2013, the Idaho Legislature overwhelmingly passed a resolution against ever legalizing any form of marijuana use for any purpose.

Sen. Shawn Keough, R-Sandpoint, co-chair of the joint budget committee, said she supported the vetoed bill last year; it passed the Senate 22-12 and the House 39-30. "It seemed, at the time, the need was greater than four and greater than 25," she said. By some estimates, as many as 1,500 kids in Idaho could use the treatment.

"It's frustrating for me that as a state, we have narrowed the options down for the kids and the parents," Keough said, adding that she wonders "whether we are denying a treatment that could give kids and parents some relief, and helping a pharmaceutical company along the way."

"I would guess that some of those parents are desperate to help their children, and will find the substance in another manner," Keough said. "If the goal is to keep this above-board, then we're certainly not helping that. I guess I'm disappointed."

State epidemiologist Dr. Christine Hahn said 29 families applied to have their children included, and beyond the initial four who already have started the program, 18 are now scheduled for their screening visits. Four more are in the process of submitting information, and three didn't qualify. Standards for the program are strict; for example, the sick children must have tried at least four different classes of epilepsy medications without receiving relief.

Hahn said requirements of the program from both the FDA and DEA are extensive; for example, the physician conducting the trial had to install a safe in his office and have the DEA come and inspect it.

"Considering the five or six agencies involved, I'm pleased that we got this thing up and running in less than a year," she said. As for whether it's helping the kids in the program, she said, "It's way too early to say."

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News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Four Idaho Kids Have Qualified To Take Marijuana-Derived Epilepsy Drug
Author: Betsy Z. Russell
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