Mean age was 11, and patients were taking a mean of 2.7 other anti-epileptic drugs (AEDs).
Mean patient age was 7.3 when starting on the cannabis products and the duration of clinician observation was 5.6 months. Diagnoses were mixed: absence seizures, focal seizures, generalized tonic-clonic seizures, myclonic seizures, epileptic spasms, Doose syndrome, Lennox-Gastaut syndrome, and Dravet syndrome were all represented.
Adding the cannabis product initially worsened the spells, but a check on valproate blood levels indicated that they had increased 50%. When the valproate dosage was adjusted downward and normal therapeutic levels were reestablished, the child became seizure-free and remained so for 5 months, with normal-appearing EEG readings.
— Thus far, only parent reports and open-label trials for support.
The concern about AED blood level effects from cannabidiol was corroborated in an otherwise encouraging case report from a group led by Jeffrey Gold, MD, of the University of California San Diego. A child with Doose syndrome was started on an artisanal cannabidiol product of unknown provenance while continuing on valproate, on which the patient initially had no spells for 2 weeks but then relapsed.
Devinsky reported the mean reduction in seizure frequency at 40% for all patients. Dravet patients appeared to derive the most benefit, with a 72% mean reduction in seizure frequency and complete seizure freedom in 22% of the group (seven of 32).
SEATTLE — Epileptic patients and especially parents of children with the condition believe that the cannabidiol component of marijuana was effective, but there remains little solid evidence that it was not just a placebo effect, researchers said here.
The 75 patients were those whose charts indicated use of medical cannabinoids, including 41 who were established Colorado residents and 34 whose parents had moved to the state in order to obtain medical marijuana.
The study by Hussain and colleagues was an online survey promoted to parents of children with infantile spasms, Lennox-Gastaut syndrome, and Dravet syndrome — all devastating seizure disorders that develop in early childhood — through Internet forums. Of 200 total respondents, 117 said they had used cannabidiol-type products with their children. Respondents were then asked to report previous treatments and to categorize the children’s treatment responses to cannabinoid therapy as seizure-free, fewer seizures, no change, or more seizures.
S ettling into London, Evelyn was almost afraid to believe how well the treatment seemed to be working. After having 68 seizures on Thursday, the day Sam and Evelyn spent at the Great Ormond Street Hospital, Sam had 10 on Friday and five on Saturday, 10 on Sunday and six on Monday. And as she increased the dose of CBD from 50 mg a day to 250 mg a day, his seizure count continued to fall. They didn’t see any side effects.
But it’s hard to imagine how we could have done it without them. Cilio had dozens of other patients to attend to besides Sam. And because she was new to the US, she had no idea how complicated and emotionally charged anything associated with cannabis can be here. The consultants showed her how to fill out the mountain of paperwork involved in applying to the FDA and the DEA. And they worked their contacts inside the agencies to make sure our application kept moving. The DEA agents, despite being antagonistic with Cilio and demanding that we get a safe to store Sam’s drugs, also moved our application along quickly when we speedily met their demands. The day we had the safe delivered to Cilio’s office, an agent visited to ensure it met DEA requirements. And he immediately advanced our application to the next step.
For the first time in a decade Sam is living like a normal boy. He takes a bus and a train home from school. He plays Halo at his friend’s house.
When they are frequent—which has been often—it’s hard for Sam to have a conversation, let alone learn anything in school. Sports? Not possible. As a little kid, Sam couldn’t even cry without being interrupted: He’d skin a knee, cry for 15 seconds, have a 15-second seizure, and then continue crying. Once, after watching a movie with me, he complained about the DVD being scratched. It wasn’t. It just seemed that way because he’d had so many seizures.
But the desperate can’t afford to be doctrinaire. And by the time another year had passed, we were desperate. Intravenous immunoglobulin hadn’t worked. And it was becoming increasingly less safe to control Sam’s seizures with high doses of corticosteroids. In May 2012 we wrote a $600 check to join the cannabis collective.
Researcher Are Finally Studying the Other Chemical in Pot
The total bill for getting GW’s CBD into the US was roughly $120,000, not including travel. Two consulting firms—one an expert in the workings of the FDA, the other an expert in the DEA—generated most of those expenses. It’s an enormous amount of money to pay for outside help, more than double what we’d thought it would cost.
Sam has seen six neurologists at four hospitals in three states. Photo by: Elinor Carucci