JANESVILLE, Wis. - The Hiles family says they're running out of options to treat their six-year-old daughter Adalyn's seizures.
They believe a recently FDA-approved drug called Epidiolex could help her, but it's being held back by legal hurdles because it contains cannabidiol, a constituent of cannabis known as CBD.
At three-months old Adalyn was diagnosed with Aicardi syndrome, a rare form of epilepsy causing uncontrollable seizures.
"The EEG shows almost constant epileptic activity. Her clinical events are fewer than that, but because the electrical activity is occurring so often, it affects her function," said Dr. Frederick Edelman, Adalyn's pediatric neurologist.
Caring for Adalyn has become a way of life for her family.
She must take six different seizure medications twice a day, each with their own set of dangerous side effects. But Adalyn still has five to six seizure events per night, each lasting 10 minutes to an hour.
"It's one of us usually that's holding her, that's tending to her while she's seizing and so her sisters have kind of caught on to that," said Liz Hiles, Adalyn's mother.
Her parents have recently started to give her CBD supplements bought at a local health store. They say the supplements have decreased Adalyn's seizures to about one per night, but they're paying almost $300 out of pocket for enough for about 30 days.
They also worry that the store-bought supplements are not regulated and being taken without a doctor's guidance. Jason and Liz are forced to do their own research to figure out how much of the CBD supplements to give their daughter.
"This is a girl that's got really severe medical issues, and we've buying stuff at a health food store that's labeled as a supplement to take care of it. And it's actually more effective than the thousands of dollars of medications that we have right now from the pharmaceutical companies," said Jason Hiles, Adalyn's father.
Seeing this positive result from CBD makes her parents even more confident than Epidiolex will work for Adalyn.
"We're at the point now where our backs are kind of to the wall and we need a different option. So it could absolutely be life altering for her and for our family," said Jason.
The drug was approved by the FDA for use in patients with similar epileptic conditions. Dr. Edelman believes it could help control Adalyn's seizures as well.
"Nothing in medicine is the holy grail. There are always benefits and side effects and we're going to take that same attitude toward this drug," said Edelman.
He said although studies show good results treating other forms of uncontrollable epilepsy, doctors are still not sure why CBD is working. Marijuana is still a schedule I drug so they haven't been able to research it.
It took about three months after the FDA approved Epidiolex for the Drug Enforcement Administration to change Epidiolex from a schedule I drug to a schedule V.
Some believed the DEA would reschedule CBD all together, but they only changed the classification of FDA-approved drugs containing no more than 0.1 percent tetrahydrocannabinols. According to Forbes, Epidiolex is currently the only drug in this classification.
A representative with Wisconsin's Controlled Substances Board previously told News 3 they must wait 30 days after the DEA reschedules Epidiolex, which happened on Sept. 27, to approve it in the state.
After this story was published, the representative contacted News 3 to say he made a mistake. The board must re-schedule the drug within 30 days, not after.
"It's like you have cancer and someone has a cure. And they're like, 'Hey I've got this cure.' Alright great, can I have it? 'Nah, I'm going to keep it, I'm going to hold on to it. Let's wait awhile,'" said Jason Hiles.
The Hileses are tired of waiting for something they believe can extend their daughter's life past the 18 year life expectancy with Aicardi.
"She could live into her 40s or 50s, it really all depends on how we control those seizures and those spasms. Her life depends on it," Jason.
Her parents hope Epidiolex can eventually replace all of the drugs she is currently taking. Although they believe a prescription of Epidiolex would be covered by insurance, it could be pricey for other families.
The Wall Street Journal reports the pharmaceutical company plans to charge $32,500 annually per patient.
After this story was published, the Controlled Substances Board reached out to News 3 with more information. They will have a teleconference on Oct. 9 to schedule Epidiolex in Wisconsin and discuss the approval of state-licensed pharmacies and physicians to dispense the drug.
That decision will go into effect on Oct. 15.
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