Members of the epilepsy community in the Chicago area were encouraged by the Food and Drug Administration’s recent approval of the first cannabis-based prescription drug, a move that some hope will lead to more extensive research into marijuana’s medical effects and a wider acceptance of medications derived from the drug.
Last month, the FDA approved Epidiolex to treat two rare forms of epilepsy in children 2 years or older. The strawberry-flavored syrup uses cannabidiol — or CBD, a non-psychoactive form of cannabis — to control seizures, although it’s unclear how exactly. Before Epidolex can be brought to market, the Drug Enforcement Administration needs to formally reclassify CBD into a category of drugs that have received medical approval. The agency is expected to announce a decision in the next few months.
Ayesha Akhtar, the director of education at the Epilepsy Foundation of Greater Chicago, said the organization saw a flood of inquiries from people who were “ecstatic” about the FDA’s announcement.
“If you just check out our Facebook page the day that we posted, so many families were saying, ‘Finally! When can I get it? How can I get it? I can’t wait for it also to be approved for my type of epilepsy,’” Akhtar said.
She added that the drug’s approval marks a “sea change” for epilepsy treatment. Medication management has typically been the first course of action after an epilepsy diagnosis, which can often be difficult to treat because traditional anti-epileptic drugs don’t work for many people dealing with the disorder. The next approach could be a switch to a new diet — such as the high fat, low-carbohydrate ketogenic diet — or even surgery.
Experts can now hold up CBD as a viable treatment option earlier in the process.
“It’s really exciting for us to push that up in the conversation a lot sooner,” said Akhtar, who thinks the potential reclassification of CBD could lead to additional research into how cannabis-based treatments interact with traditional drugs. She’s also confident that more drugs like Epidiolex will eventually be federally-approved.
“I feel like it’s the government’s way of saying, ‘Yeah, we get it, [anti-epileptic drugs] don’t work for 30 percent of the population, let’s try to find an alternative therapy,’” Akhtar said.
Ashley Surin, 12, started having epileptic seizures after being diagnosed with Leukemia in 2008. After eight years of unsuccessfully cycling through traditional medications, she began taking medical cannabis to manage her condition. Her mother, Maureen Surin, now refers to the drug as a “medical miracle” and views the FDA’s decision as a step in the right direction.
“There’s so much value in CBD that we need the research to keep going,” Maureen Surin said. “We need the government behind it.”
Despite being encouraged by the prospect of the DEA reclassifying CBD, the mother isn’t completely sold on Epidiolex. After her daughter’s neurologist recommended the drug, she looked into it and was turned off by the synthetic ingredients and side effects, which include diarrhea, vomiting, fatigue and sleep problems.
“I’m happy that they’re getting that there’s value in CBD, but I wish they could wipe away those side effects,” she said.
In January, Surin and her husband, Jim, filed a federal lawsuit against the state and Schaumburg School District 54 after Ashley was barred from class for medicating with the drug. The following month, state Rep. Lou Lang, D-Skokie, introduced “Ashley’s Law,” a bill would allow parents or guardians to medicate their children with cannabis while they’re at school. In April, a federal judge ultimately ruled in favor of the family and Lang’s measure is currently being considered by Gov. Bruce Rauner after garnering overwhelming bipartisan support in both houses of the Legislature.
Meanwhile, Ashley continues to take a cannabis mixture that’s 95 percent CBD and 5 percent tetrahydrocannabinol — or THC, the ingredient in marijuana with mind-altering effects. While the DEA could declassify CBD in a matter of months, there is no such plan for psychoactive THC, which some experts say is needed to open receptors to CBD to stop the convulsive effects of epilepsy.
Nevertheless, Surin is satisfied with her daughter’s current course of medication and wouldn’t want to risk switching to a new drug.
“My daughter’s having a beautiful, normal, side effect-free, seizure-free life,” she said. “How could I perfect on that?”
Unfortunately for the family, health insurance providers don’t cover cannabis products and their costs are mounting. Surin estimated that they’ve spent roughly $6,000 so far this year on her daughter’s cannabis-based medications.
Like Akhtar, the mother is hopeful that the FDA’s announcement will lead to additional research and the approval of more cannabis medications that would be covered by insurance providers. She also hopes the move signals changes to other federal restrictions that prohibit most doctors from prescribing medical cannabis and forbid medical cannabis patients from traveling out of state with their medications.
“There should be no discrimination against a medicine,” Surin said. “The laws need to catch up with reality.”