Seventeen medications during the past four years have failed to quell the haywire electrical signals in Haley Osborn’s brain that send her young body into convulsions dozens of times a day.
The 7-year-old climbs into bed at night with her service dog, Sofie, a border collie mix trained to push an alarm with her nose when the seizures start, summoning Haley’s parents. The dog then gently lays her body over Haley to protect her from hurting herself.
Now Jill and Arthur Osborn of Georgetown would dearly love to have their daughter try marijuana, after hearing that it helped children in Colorado with severe, unrelenting seizures. But more than a year after voters approved legalizing marijuana for medical use in Massachusetts, Haley and hundreds of other children with severe epilepsy are still waiting to get the drug.
Dispensaries authorized to sell marijuana are not expected to open until this summer at the earliest; the state is expected to award the first 35 licenses this week, but it will take months more for the chosen companies to grow their products and negotiate with local authorities for building and other permits. Even then, there is no guarantee the stores will stock the strain of marijuana believed to help prevent seizures, and federal law prohibits families from having the drug shipped to their homes from other states where it is legally sold.
“We are desperate to help our daughter, and running into obstacles at every turn,” said Jill Osborn. In the interim, Haley wears a padded helmet to protect her head during seizures, and attends school only part-time, with a nurse at her side.
In November, when Haley was hospitalized for an uncontrollable seizure, and physicians considered putting her into a medically-induced coma for the second time in her short life, the Osborns thought about packing up and moving to Colorado to get marijuana specially grown for people with epilepsy.
“We don’t think we should have to uproot our medically fragile child and our whole support team to go there,” Jill Osborn said. “We shouldn’t be limited because of geography.”
Marijuana is promoted as a treatment for a long list of ailments, though few rigorous studies have been done to show it works. For children with epilepsy, however, the evidence of marijuana’s benefits is slowly accumulating. A handful of small studies have suggested that one primary ingredient of marijuana, cannabidiol, or CBD, might reduce the frequency of seizures, and a study starting soon at MassGeneral Hospital for Children and four other hospitals nationally will test CBD on young patients who have seizures that are not controlled by traditional drugs.
Unlike THC, the ingredient that causes marijuana’s high,” CBD is nonpsychoactive, and it has captured widespread attention amid anecdotal reports that it has helped tame seizures in children in Colorado and California.
Many of the medications available for children with epilepsy have severe side effects that can impair their development, memory, behavior, and mood, so parents have become desperate to get marijuana for their children.
“Haley has tried every medicine on the market, as well as steroids, as well as a modified [anti-epilepsy] diet. She is kind of out of options,” said Dr. Ronald Thibert, a pediatric epilepsy specialist at Mass. General who treats Haley.
“For kids like her,” Thibert said, “even if we don’t know all the effects of CBD, the other alternatives are not great.”
Mass. General treats more than 2,000 children with epilepsy who have seizures that are resistant to medications, but federal regulators have authorized the CBD study to enroll only 25 children at each site. The Osborns are hopeful that Haley will be among the chosen few.
The one-year study is primarily testing whether a drug called Epidiolex, manufactured by a British company that extracts the CBD from marijuana, is safe for use in children and whether it has side effects.
A secondary goal will be to measure whether Epidiolex eases intractable seizures. About one-third of patients with epilepsy are not able to control their seizures with drugs or surgery, according to the National Institutes of Health. As many as 8,500 Massachusetts children are estimated to have such uncontrollable seizures.
For the many children who will not be selected for the study, another challenge will be getting physicians to sign a form certifying them to legally purchase marijuana for medical use. State law requires one physician certification for adults, and two for children.
Haley’s mother has secured one signature from her daughter’s longtime pediatrician, but the Mass. General specialists who treat Haley have hesitated, in part because their hospital has not yet developed a policy on the issue, said Dr. Elizabeth Thiele, director of Mass. General’s pediatric epilepsy program.
“The problem in signing the forms is, we won’t necessarily know what our patients will be getting,” she said, noting that there is “significant variability” among medical marijuana preparations.
Massachusetts’ medical marijuana rules are considered more stringent than many other states’, requiring dispensaries to have an independent lab test their products for contaminants such as pesticides and mold, and for potency, but there is no mandate that store personnel have the expertise to match a patient’s specific illness with the strain of marijuana most likely to be of benefit.
When dispensary doors finally open, it is not clear how many will sell marijuana rich in CBD. Andrew DeAngelo, director of operations at Harborside Health Center, a large California marijuana dispensary that carries CBD-rich products, said he is unlikely to initially grow such strains in Massachusetts if he wins one of the coveted dispensary licenses. He hopes to open in Suffolk County.
“I have to start a production facility in Massachusetts, and it has to be able to pay for itself,” DeAngelo said. “So I have to grow things I know I will be able to sell, and most people who come into a dispensary are looking for THC, not CBD.
He said cancer patients, for instance, typically benefit from strains with higher concentrations of THC.
But at least one dispensary applicant said he is committed to growing marijuana that might help Haley and other children with seizures.
“We are not worried about the small, added cost to growing strains that are not in high demand,” said Brandon Tarricone, chief executive of Medicinal Evolution, which intends to open in Essex County, if granted a license.
Tarricone has been consulting with Haley’s mother, who has been researching CBD strains in other states as she awaits word on whether Haley has been chosen for the Mass. General study.
“I am not the kind of person who is going to sit back and wait for this to happen for us,” Jill Osborn said. “I am a mom, and that trumps everything.”