April Sintz is fighting to loosen marijuana laws for her 7-year-old epileptic son. She is one of hundreds of moms nationwide who have opened a new front in the drive to expand the drug's legal use.
While supplying pot to a child is bound to raise eyebrows, Sintz said that early evidence on the marijuana extract cannabidiol, also known as CBD, suggests it's a potent anticonvulsant with few dangerous side effects. That could help save the life of her son, Isaac, who has 30 seizures or so a day and suffers with kidney damage from his present treatments.
"We're probably going to lose our son to his kidneys or his seizures," said Sintz, of South Jordan, Utah, near Salt Lake City. "We can't find a medication to safely control those seizures, which is why we're so excited for this oil."
So far, the oil hasn't been tested in large randomized trials that could prove its safety and efficacy.
The most recent data came June 17, when researchers reported that a purified form of CBD made by GW Pharmaceuticals, a British-based developer of drugs derived from cannabis plants, reduced seizure frequency by at least 50 percent in 12 weeks in 27 patients. The average age of the participants was 10, and all had failed on other treatments. Only mild or moderate side effects, including sleepiness, were recorded.
Larger trials are scheduled ahead.
More than 300 patients, including children with intractable epilepsy syndromes, are now enrolled in 12 trials with the drug, said Steve Schultz, GW Pharmaceuticals' vice president of investor relations.
The lack of scientific evidence hasn't kept the parents of children with severe epilepsy from turning to it, though, based on anecdotal evidence carried across the Internet.
After Sintz first heard about the compound, she joined and helped lead a nonprofit called Hope 4 Children with Epilepsy that set up educational events and lobbied state lawmakers in a campaign that resulted in Utah becoming one of just 11 states to allow use of the marijuana extract by youngsters, all coming this year. Twenty-three states allow medical use of marijuana for other conditions including cancer, glaucoma and HIV/AIDS.
Utah's health department last week began issuing registration cards, and Sintz said in a telephone interview that she's planning to get one for her son within the week, so the family can legally possess and treat Isaac.
Not 'marijuana moms'
Initially, "we were known as the marijuana moms, which we are not obviously," Sintz said about the process of getting a bill through the state Legislature. "But as soon as they sat down with us and heard about our children and what we're going through on a daily basis, they changed their tune."
About 2 million people in the U.S. have epilepsy, with a quarter of those being children, according to data from the Centers for Disease Control and Prevention. About 30 percent of people with the disorder have seizures that aren't responsive to existing medications, according to the U.S National Institute of Neurological Disorders and Stroke
For Isaac Sintz, the middle child between two sisters, that tale began when he was 6 months old and suffered his first seizure. His second and third came at the ages of 9 months and a year, and he began having regular daily seizures at 3, Sintz wrote in a blog.
He was diagnosed with Dravet Syndrome, a genetic illness that causes seizures from infancy. He began a series of different treatments that included medications, supplements and diet. The end result, though, was that the treatments sapped his strength in other ways and, eventually, came with kidney damage.
"We have no other options," Sintz wrote on the blog. "We have tried everything."
The parents say that the CBD extract doesn't carry pot's ability to leave users stoned, and can be a safer alternative to the 20 or so standard, U.S.-approved drugs for epilepsy that carry side effects that range from drowsiness, nausea and weight changes to dangerous brain and kidney damage.
FDA fast track
In June, the U.S. Food and Drug Administration granted the drug fast track status for two epilepsy diagnoses, a designation that helps expedite development and the agency's review of medicines to treat serious conditions.
Elizabeth Thiele, director of the pediatric epilepsy service at Massachusetts General Hospital, said it's important to get those results since no other research at this point goes to CBD's long-term safety. She is currently running one of the trials testing GW Pharmaceuticals drug.
"My gut is that CBD is going to be pretty safe, but it would be nice to know that," Thiele said in a telephone interview. "I don't personally think that there's enough data for me to start prescribing medical marijuana to people."
States are concerned as well. In most cases, the new state laws — including Utah's — require registration of the child, a recommendation from a neurologist and a product that contains only very low amounts of tetrahydrocannabinol — or THC, marijuana's psychoactive compound — and high CBD content.
Some states have also built research into their laws. Alabama, for instance, appropriated $1 million for an open clinical trial, while Florida, Missouri and Utah require neurologists to collect data on patient response and share it with the state for study purposes. Laws in Kentucky, Tennessee, North Carolina and South Carolina require patients be enrolled in a clinical trial, or only allow doctors at research universities to recommend CBD oil.
Maria La France of Des Moines, Iowa, whose 12- year-old son, Quincy, also has Dravet Syndrome, said drugs used to control his seizures left him with brain damage.
"How ironic that the federal government is so concerned about cannabis when these FDA-approved drugs have caused so much damage to my son," France said.