Iowa: Davenport Boy Is Part Of FDA-Approved Cannabis Study
Ryan McDermott spent his New Year’s Eve knocked out from Valium. It’s the “rescue med” the 8-year-old’s mother, Tina McDermott, turns to when his seizures last for hours at a time.
“I had to,” the Davenport mother of six said. “I didn’t have any choice.”
Diagnosed as a toddler with a rare intractable epilepsy known as Dravet syndrome, Ryan has been on multiple medications his entire life, and his mother thought taking four at one time was too much. Now he’s on five, including one that dealt him a bout of pancreatitis.
“He’s never been on five meds before,” Tina McDermott said. “I don’t like that amount of meds. I don’t think that’s the right answer.”
The answer could come from a cannabis-based medicine for which FDA approval is being sought. The Davenport boy was selected among a handful of juvenile Dravet patients to participate in a clinical trial at University Hospitals, Iowa City.
Dr. Charuta Joshi, Ryan’s neurologist and director of pediatric epilepsy at University Hospitals, will give Epidiolex orally to participants in a 12-week double blind study that she says is supposed to begin this spring.
Epidiolex, created by U.K.-based GW Pharmaceuticals, is purified cannabidiol, or CBD, mixed with an artificial sweetener to create a syrup-like product.
“Parents wanted to make sure they’re not making an emotional decision alone to put their children on this drug,” Joshi said.
Ryan’s trial is the second phase of a nationwide Epidiolex study that began last year. The results of the first phase — to determine the ideal dosage for the drug — are pending. Ryan will be part of a trial to evaluate the drug’s safety and efficacy.
“To date nobody knows what CBD does to a child’s body,” Joshi said.
CBD is one of multiple cannabinoids identified in cannabis. Unlike tetrahydrocannabinol, or THC, which is another cannabinoid, CBD does not produce a psychoactive effect.
Iowa native Rachael Selmeski, who lives in Colorado, has given a CBD-rich oil called “Charlotte’s Web” to her 3-year-old daughter Maggie for more than a year. She said Friday she has seen an 80 percent reduction in her daughter’s seizures.
“We’ve weaned her off all pharmaceuticals,” Selmeski said. The CBD oil is “doing better for her than three pharmaceuticals combined.”
Maggie’s parents also have noticed cognitive improvements on the oil.
“She’s much more aware of what’s happening around her,” Selmeski said. “Developmentally, she’s gaining more and more head control and bearing a little weight on her legs when we hold her up.”
Colorado is one of 23 states that have decriminalized marijuana for patients suffering a variety of ailments. Iowa passed a CBD oil law last year that’s meant only for patients suffering intractable epilepsy, although not a single Iowan has yet been allowed access.
A national Dravet advocate says she wants to learn more about CBD-based medicine before pinning her hopes on a drug that the federal government still deems illegal.
“This is a population desperate to do anything for their children,” Dravet Syndrome Foundation executive director Mary Anne Meskis said.
Her 14-year-old son Elliot is one of 1,200 patients nationwide diagnosed with Dravet. The Chicago mother understands the frustration with prescription drugs because none of them has kept her son seizure-free, and the side effects leave him lethargic.
“It comes to the point where parents and physicians realize being seizure-free is not an option,” Meskis said. “He’ll never live independently. He’ll never hold a job.”
Dravet syndrome is a qualifying condition in Illinois, which was expected to award licenses to grow and sell marijuana before the end of 2014. The deadline was not met, and a new one hasn’t been announced.
Meskis said the challenge is asking growers to supply a very small population of Dravet patients who are seeking CBD oil, as strains high in THC seem to be much more popular, even among medical users.
“You may still see an exodus of families to Colorado,” Meskis said.
McDermott said she would have to leave her husband, Brad, and her other children behind in order to move with her son out of state, and she can’t afford to travel, pay rent on a house and buy her son’s medicine. She said her husband makes $70,000 a year as a service manager at Lujack Kia Mazda, Davenport, and she makes “pennies” cleaning houses.
“I don’t know if we’re middle class or poor,” she said. “But I know we don’t have a lot of money.”
McDermott and Maria La France, another Iowan with a child suffering Dravet, lobbied University Hospitals to be a site for the Epidiolex trial.
“We’re running out of options,” McDermott said. “Do I want Ryan on four or five meds? No. I hate it. I’m holding out hope for this Epidiolex trial. Iowa is moving at a snail’s pace because people think marijuana is such a bad thing.”
Author: Brian Wellner Source; http://qctimes.com/news/local/davenport-boy-is-part-of-fda-approved-cannabis-study/article_8b271740-82f5-5ca2-84db-2a743c0f1fe9.html