Their mothers have known each other for years, though it’s a hapless coincidence caused by their daughters’ epilepsy that brings them to the pediatric unit on the same day.
The two women are part of a tenacious group of parents and national marijuana advocates demanding that politicians and state legislators legalize medical marijuana treatment for their children, whose medications have had limited success treating seizures and other severe conditions.
“This is something that needs to happen across the country so that every child who might need this would have access,” said Julie Michaels, Sydney’s mother and a member of Campaign for Compassion, which is pushing for comprehensive medical marijuana laws in Pennsylvania. “Why should the state lines be the factor as to whether my child can get help or not?”
Sydney is one of only a few hundred children around the country enrolled in a clinical trial to test the use of marijuana-based treatments for epilepsy. But Hannah is not.
“I’m watching my daughter die every day,” said Heather Shuker, Hannah’s mother. “Hannah has so many seizures, and every seizure could take her from me. I firmly believe that medical cannabis will help her.”
“There’s so much that I want for her right now that she just can’t do,” Michaels said about Sydney. “Just being able to go out and experience life, to be able to go out and play in the yard without fear of seizures starting.”
Since 2014, 17 states have legalized the use of marijuana-derived cannabidiol (CBD) in children: Utah, Wyoming, Wisconsin, Iowa, Missouri, Oklahoma, Texas, Louisiana, Mississippi, Alabama, Tennessee, Georgia, Florida, South Carolina, North Carolina, Kentucky and Virginia. The laws are intended mostly to treat intractable epilepsy and, in some cases, other conditions. Florida, Georgia and Louisiana, for example, allow limited medical marijuana use for cancer treatment.
CBD is the non-psychoactive component of the marijuana plant. It has yet to be proven scientifically as a successful treatment, though anecdotal evidence suggests it helps some children. Tetrahydrocannabinol (THC) is the part of the plant that produces a high, but it is also known – if not proven – to treat pain, nausea and insomnia, among other symptoms.
The 17 states that recently passed CBD legislation all placed limits on the THC concentration of medical marijuana extracts to minimize the psychoactive effects of the medication. They range from 0.3 percent in Oklahoma to 5 percent in Georgia.
Shuker said her daughter Hannah, diagnosed with severe intractable epilepsy and Lennox-Gastaut syndrome, has about 250 seizures a month. They have tried more than 18 different seizure medications and special diets.
Pharmaceuticals made her daughter’s seizures worse, Shuker said. Hannah now has a surgical feeding tube because she can no longer swallow on her own. Doctors have told Shuker that Hannah’s only remaining option to try to reduce the seizures is a brain surgery procedure, with risks of infection, increased seizures or stroke.
Meanwhile, visits to the emergency room and pediatric ward have become routine, Shuker and Michaels say their lives revolve around doctor appointments and unexpected stays in the hospital. While other mothers track their children’s height on walls with markers, these mothers track dates and times and numbers of seizures on homemade charts.
Sydney is one of 25 children in the clinical trial at Children’s Hospital of Philadelphia who are receiving doses of Epidiolex, a purified CBD created by London-based GW Pharmaceuticals. Part of the drug’s attraction is that it is low in THC.
“Prior to this study, she couldn’t do a puzzle. After about two weeks, she was whipping through puzzles on an iPad and we’re like, ‘Who is this kid?’” Michaels said. “We’re talking about a kid who was seizing easily from 1,000 to 3,000 times in a week. It was incredible.”
Dr. Eric Marsh, assistant professor of neurology and pediatrics at the Children’s Hospital of Philadelphia and attending physician for the Philadelphia clinical trial, was cautiously optimistic about the overall results, with parents reporting a 50 to 60 percent reduction in their children’s seizures. However, Marsh encourages families to wait until marijuana-derived medications earn Food and Drug Administration (FDA) approval.
“There’s so much interest and excitement over this that it really could skew results,” Marsh said. “It does seem that CBD interacts with some of the other medications. Clearly it’s not a miracle drug. It has interactions with other drugs, and it does have side effects.”
For many parents, the 2013 airing of the CNN documentary “Weed” was the watershed moment that ignited a movement to make cannabis oil available to children. The report featured Charlotte Figi, a then-five-year-old girl from Colorado Springs, Colorado, who used cannabis oil to treat the 300 grand mal seizures she suffered each week.
The oil she uses, Charlotte’s Web, is named after her and produced by Colorado-based Stanley Brothers Social Enterprises.
“We tried this on her, and it stopped her seizures,” said Paige Figi, Charlotte’s mother. “Now, three and a half years later, she has two seizures a month – down from 1,200.”
“They’ve responded very well, obviously it’s not a silver bullet for everyone,” said Jesse Stanley, who grows and produces the oils with his brothers. Their nonprofit, the Realm of Caring, offers oils to patients at reduced prices.
Many other parents, inspired by Charlotte Figi’s story and frustrated with unsupportive politicians, have since moved from their home states to Colorado, where marijuana treatments are legal. According to the Colorado Department of Public Health and Environment, there are 434 children on the state’s medical marijuana registry. In August 2013, there were 60.
“The first ‘Weed’ presentation was in August of 2013, and so we started getting a lot of phone calls starting in September and October, and started seeing patients in November and December,” said Kevin Chapman, a neurologist at Children’s Hospital Colorado.
Chapman sees many of the children using cannabis oil to treat their seizures, including those whose families moved to Colorado in the last two years. He authored a report last year that measured the effectiveness of using cannabis extracts to reduce seizures. He and other doctors surveyed the parents of 75 children in Colorado and concluded that 33 percent of parents said they saw their children’s seizures reduced by more than 50 percent.
The Denver neurologist understands the limitations of his study, starting with the sample size of 75 children – who all used different oils, each with its own chemical make-up. Making matters more complicated, the participants had different types of epilepsy that ranged in severity. The study also depended on parental reporting, which Chapman says can produce biases.
The report said the study results highlighted “the need for controlled studies to evaluate the efficacy and safety of oral cannabis extracts for treatment of pediatric epilepsies.”
“Families picked up and moved to Colorado with the hopes that it’s going to make their child better,” Chapman said. “All of us in that situation would hope that it really works, and therefore we think that there might be some bias that could skew the numbers to suggest that it’s a bit more effective.”
Dr. Larry Wolk, chief medical officer and director of the Colorado health department, said he could not ignore the anecdotal success stories reported by parents, but more research needs to be done.
“You only hear about the children it helps. The problem is that it doesn’t help everyone. The results are mixed,” Wolk said. “As a physician, I’m worried that we’re rushing this.”
Despite the lack of scientific evidence, families have become medical refugees – leaving their homes to chase the uncertain prospect that medical cannabis may save their children’s lives. Many believe medical cannabis is their last option.
Earlier this year, 9-year-old Alexis Bortell of Dallas had one of her worst seizures and was taken to a hospital. For moments at a time, she stopped breathing. A week later, she suffered stroke-like symptoms, said her father, Dean Bortell.
Anti-seizure pharmaceutical drugs like Depakote and Carbatrol did little to stop her seizures and seemed to incite a range of side effects such as anger. “We had to put all the knives in the house up out of her reach,” her father said.
“She was just not herself,” Dean Bortell said, “ That’s when Liza and I, my wife, decided it’s time to go.”
They moved to Colorado earlier this year. Today, Alexis wakes up early every morning to take her dose of CBD oil with a drop of THC in her new home in Littleton, Colorado. She swallows the oil through a syringe twice a day.
“I would describe it like an earthy taste,” Alexis said.
What follows is a very active schedule: playing with Purdy the service cat, Skyping friends in Texas, shooting hoops, golfing practice, playing at the park, swimming and ending the day eating frozen yogurt at Yogurtini.
“It has changed my daughter’s life in the most positive way, humanly possible,” Bortell said, adding that she hasn’t had a seizure in 100 days. “We’ve got our little girl back.”
Thirteen-year-old Austin Hilterbran also is a medical refugee, having moved with his family from his home in Choctaw, Oklahoma to Colorado just last year. Two years ago, he was on life support seven times because the drugs he took for Dravet syndrome, a severe form of epilepsy, damaged his internal organs, his mother said.
“You are leaving your home for something you don’t even know is going to work,” Amy Hilterbran said.
Austin started taking CBD oil with THC, a combination his mother calls “Austin’s Answer.” Hilterbran said his seizures are down by 90 percent and she’s weaned him off 70 percent of his pharmaceutical drugs. He walks on his own, something he’s rarely done.
“He gets to be a little boy,” she said. “He’s able to communicate because he’s not in a pharmaceutical fog.”
Pushing the limits
Despite the legislation passed in 17 states, obtaining CBD is not as simple as buying the oil off a dispensary shelf. States such as Alabama and Tennessee only dispense oils through clinical trials at universities. Florida and Texas allow for the production and distribution of oils to qualified patients in the state, but their programs are not yet operational. Other states such as Iowa and Virginia don’t define methods of access in their laws.
Parents also say that the list of qualifying conditions for medical marijuana treatment should be extended to include conditions such as cancer and bowel diseases. But perhaps the most contested component of the laws is the THC limits.
In Colorado, the Bortells and Hilterbrans add droplets of concentrated THC into their children’s cannabis oil treatments – something that would be illegal in their home states of Texas and Oklahoma.
“It’s vital for people to know that she is not just taking CBD oil. She is taking CBD oil mixed with THC,” Dean Bortell said.
Bortell believes that adding THC to his daughter’s medicine will increase the effectiveness of seizure control.
The benefits of combining THC and CBD, a concept known as the “entourage effect,” was first researched and documented by Dr. Raphael Mechoulam of Israel, who concluded that the 400-plus chemical components of marijuana work better together than in isolation.
The FDA, which monitors most clinical trials, has not approved any marijuana-related treatment. Its website warns parents of using these untested treatments.
“We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences,” the FDA statement says. “Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market.”
Steve Schultz, a vice-president at GW Pharmaceuticals, said the FDA has authorized 450 children across the country to participate in clinical trials with Epidiolex. “We don’t argue with the fact that these parents want to help their children.” Schultz said. “But it takes time and money. It’s an onerous process in place for the protection of the consumer and the patient.”
While early observations from Epidiolex clinical trials are promising, it’s uncertain if and when the drug will be readily available.
The Cannamoms, a group of mothers from Florida advocating medical marijuana, made a trip to California last year to see if cannabis oil would work on their children. Florida’s program, legalized in 2014, is not yet operational.
Jacel Delgadillo of Miami said she was seeking alternatives to medications her four-year-old son has taken since he was seven months old to treat intractable epilepsy. “I actually had one day with no seizures. That’s very unheard of in Bruno’s case,” Delgadillo said of her visit to California. “All he was taking was the cannabis oil.”
Until the oils are available in Florida, Bruno is back on powerful anti-epileptic medications. His latest drug is potassium bromide – a veterinary drug used on dogs that is not approved by the FDA.
“Today there is nothing available, but if we wanted to prescribe another drug that is more harmful to him, it would be available right away,” said Delgadillo.
The new law allows no more than 0.8 percent THC to be used in the oils. “Here in Florida, when that bill is up and running, the higher THC won’t be available, even though some patients would definitely benefit from it,” Delgadillo said.
Not all Florida parents are as enthusiastic about using THC on their children.
“From a children with epilepsy standpoint, I don’t know if I am interested in THC products, personally for my daughter. There are studies that show that high THC is not good for the developing brain,” said mother Holley Moseley, whose 12-year-old daughter RayAnn suffers from epilepsy and cerebral palsy.
Holley Moseley and her husband Peyton Moseley are among the many parents who fought for cannabis. They hired two lobbyists to help send a bill through the state legislature. Several days before Florida Republican Gov. Rick Scott signed the bill, their daughter RayAnn Moseley was invited to his office, where he promised the bill would go through.
“It was pretty special,” Holley Moseley said, “to know that this little person is changing Florida law.”
Lex Talamo is a Hearst Fellow. Calah Kelley is a Knight Foundation Fellow.