Tina McDermott lays her 9-year-old son Ryan down flat on the living room floor and places her leg on his chest.
His arms stiffen and his eyes gaze blankly out to one side while his mother mixes a cocktail of PediaSure, three pharmaceutical drugs and a few drops of cannabis oil.
“Wait a sec,” she says. “He’s still tight.”
He has a seizure as the cocktail flows through a tube straight into his abdomen. After a few seconds, his body loosens back up.
Then his mother scoops the 45-pound child and cradles him on the couch.
“This is what we do,” says the Davenport mother of six, her eyes wide with anxiety.
She has every hope cannabis oil will eliminate her son’s seizures and she can eventually ween him off pharmaceuticals.
Ryan is one of a handful of children participating in a clinical trial at University Hospitals, Iowa City. After a 12-week double blind study over the summer, he started on Aug. 26 taking Epidiolex, a purified cannabidiol, or CBD, created by GW Pharmaceuticals, based in the United Kingdom.
Diagnosed as a toddler with Dravet syndrome, Ryan was practically dealt a life sentence of intellectual disabilities and daily seizures. He’s been on 17 different anti-seizure medications.
Since being on the oil, each new seizure gives his mother pause.
Within the hour of getting his breakfast last Tuesday, he has three more seizures, each lasting a few seconds.
The day before, he suffered what his mother says was a “grand mal” seizure — the worst kind, where he can lose consciousness as his muscles violently contract. That kind of seizure, which can be stopped only by a heavy dose of Valium, wipes him out for the rest of the day.
“He had a rough day yesterday,” she says.
McDermott has not seen a grand mal seizure since before her son started taking the cannabis oil.
She wonders what is going on behind Ryan’s sparkling, smiling eyes.
“You’re in there. I know it,” she says to him.
For someone who has never spoken a word in his life, Ryan sure says a lot.
A few days earlier, with his favorite show SpongeBob SquarePants on TV and his favorite Grinch toy tucked under his arm, the boy bounces around on the floor, squealing with delight.
But nothing tickles his heart more than the sound of his older brother Jake’s voice on the other end of the phone line.
McDermott puts the phone up to her son’s ear.
“What’s up, buddy?” Jake is heard saying.
Then Jake pretends to cough, which always makes Ryan laugh.
The boy flashes the widest grin at his visiting nurse, Jami Witbeck, as she stomps over to the couch and smothers him with kisses.
And Ryan gets all wiggly whenever his brother’s girlfriend comes for a visit. He is quite the ladies’ man, his mother says.
McDermott dreams of the day when more of her son’s personality can come alive, that for once he could finally utter the word “mama.”
She’s sticking with the cannabis oil for now.
Oil shows promise
Earlier this year, the American Academy of Neurology released results of another GW Pharmaceuticals-sponsored study involving 213 people with severe forms of epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome, or LGS.
Unlike the double-blind study Ryan was in, participants knew from the start they were receiving cannabidiol. For the 137 people who completed the 12-week study, the number of seizures decreased by an average of 54 percent, the academy reported.
For the Dravet patients, the number of convulsive seizures had gone down by 53 percent by the end of the study. For those with LGS, there was a 55 percent reduction in the number of atonic seizures.
Side effects that occurred in more than 10 percent of participants included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent), the academy reported.
Six percent of participants dropped out of the study because of the side effects.
The study’s author Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center, wrote in the academy’s report that the results looked promising.
“These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures,” Devinsky wrote.
Cannabidiol, which GW Pharmaceuticals is marketing as Epidiolex, is a component of marijuana that does not include the psychoactive part of the plant that creates a “high.”
The open-label study was designed to determine whether the drug was safe and tolerated well.
Ryan McDermott and a handful of other Iowa children were picked to participate in the next study.
Caleb Helland is an 11-year-old from Mason City diagnosed with LGS.
His mother, Cassie Helland, was sure he was on the placebo during the first part of the study, because she did not see any changes. Then, on Sept. 4, he started on the actual cannabis oil.
“He would have seizures daily, four or five, of just tonic. The tonic clonic, or grand mal, he would have those a few times a month,” Helland said. “So when he switched over to the open label part of the study, the first couple of weeks he still had seizures, and he was really tired.
“But since Sept. 20, he’s only had one seizure. They actually stopped. On Nov. 12, he had a tonic clonic seizure. It’s the only one he’s had. It’s been 59 days, and he’s only had one.”
Helland is relieved but not yet ready to declare victory.
Caleb is still taking anti-seizure medications such as Onfi and Depakote, although doctors have lowered the dosage of each in the past two to three weeks after seeing side effects, Helland said. All she could learn from doctors was that the interaction of the two medications with cannabis oil resulted in higher liver function.
Onfi, Depakote and numerous other medications over the years left her son seeming out of it, like he’s not even there, she said. Now he seems more alert.
“I’m actually starting to see a Caleb,” Helland said. “My goal is to actually get him off his other seizure medications one at a time and see how he reacts. I would love for him to only be on the CBD.”
Caleb, who uses a wheelchair, is welcomed at Lincoln Intermediate School by classmates who always try to find a way to include him in activities.
“He loves it,” his mother said. “He likes to watch the other kids. He gets excited. He’ll swing his arms, smile and make loud noises. Kids talk to him. Kids read to him. Everyone loves to push him in his wheelchair. It’s been a thing since preschool.”
The middle of Helland’s three boys, Caleb has little to no use of his arms and legs. When he’s on the floor, his 15-month-old brother likes to lay on him. The toddler also helps mom out and brings Caleb his diaper.
Seizures have been a daily occurrence in his life. Helland’s biggest hope for her son is that they go away completely.
“We’ve been through this so long it’s just our normal,” she said. “We’re just trying to better his life so he can live as good a life as possible. If he becomes seizure free, that would be fantastic.”
At least one family voluntarily dropped out of the study.
Maria La France of Des Moines, who lobbied the University of Iowa to do the Epidiolex study, later got her 14-year-old son Quincy out of it because of what she believed were the side effects of the cannabidiol. Quincy is another Dravet patient.
“It didn’t go well for Quincy,” La France said. “He had a lot of stomach upset with Epidiolex. So we quit the trial and went back to good old-fashioned hemp oil.”
She said she ordered some from a dispensary in Colorado, where marijuana has been legalized both for medical and recreational use.
In Iowa, it is legal for parents of children suffering intractable epilepsy to possess cannabis oil with only trace amounts (less than 1 percent) of tetrahydrocannabinol, or THC, the main psychoactive component. McDermott, Helland and La France all have Iowa medical marijuana cards.
No other patient is legally allowed to possess marijuana in Iowa.
The irony that many parents and advocates criticize about Iowa’s 2014 law is that without a comprehensive program to produce and sell medical marijuana in the state, Iowans are forced to violate federal law to bring it across state lines.
Another reason La France quit the study is that she thinks Quincy needs oil with a little bit of THC. Epidiolex has none.
“Right now, he’s on hemp oil,” she said. “He’s doing OK. We’re seeing some improvements. He’s not seizure free, which is disappointing. But he’s definitely better.”
For now, Ryan McDermott and Caleb Helland will continue on cannabis oil prescribed by doctors in Iowa City.
Ryan has his next checkup in three months, and his mother said she thinks that’s the earliest he might begin to ween off one of his other anti-seizure medications. He takes Banzel, Zonegram and Onfi.
He used to take Depakote until a bout with pancreatitis in 2014 left him hospitalized. Once he got off of Depakote, he suffered about 100 seizures in one day.
Tina McDermott says that weening him off the anti-seizure medications is a huge gamble.
“Any seizure at any time could take him,” she said.