Home secretary, Sajid Javid, intervened in Billy Caldwell case and returned a bottle of cannabis oil. EPA/Andy Rain
I have been approached by Dragonfly Biosciences who produce and market cannabidiol (CBD) to sit on their Advisory Panel. I do not receive funding from Dragonfly Biosciences, but would be paid a consultancy fee if I join the Advisory Boorad. My scientific publication support the use of non-THC cannabidinoids, as reflected in this article. I have previously received funding from GW Pharmaceuticals, but I am currently not in receipt of such funding.
One of those people is 12-year-old Billy Caldwell. Billy was in the news recently after the cannabis oil prescribed for him was confiscated at Heathrow airport by the authorities. Billy’s mother, Charlotte, was attempting to bring the cannabis oil into the UK from Canada, where cannabis oil is legal.
In a similar case, six-year-old Alfie Dingle, who suffers from severe epilepsy, had been successful treated with cannabis oil in the Netherlands. Alfie’s mother, Hannah Deacon, has been campaigning to allow her son to be provided with cannabis oil in the UK.
The reason that Billy’s cannabis oil was seized at Heathrow airport was that it didn’t just contain CBD, it also contained THC at higher levels than legally permitted.
Anecdotal evidence suggests that cannabis oil may help some of these people control their seizures and potentially save their lives. A small number of studies have shown that adding cannabis oil to existing medication may be effective in devastating, hard-to-treat epilepsy in children and adolescents.
Epilepsy drugs don’t work well, or at all, for about one-third of people with the condition. Unfortunately, these hard-to-treat epilepsies are associated with an increased risk of premature death.
The safety data from the trials in people with Lennox-Gastaut syndrome and Dravet syndrome has shown similar side effects. Tiredness, diarrhea, and upset stomach are reported the most. Interestingly, people getting the placebo also reported diarrhea and upset stomach feeling as well. This may be due to both products being oil.
This study was able to show that among people with the Dravet syndrome, CBD resulted in a greater decrease in convulsive-seizures than placebo. It also showed that CBD was associated with higher rates of adverse events.
Over half of U.S. states have laws allowing cannabis to be recommended and dispensed to people for medical reasons. The 2018 Farm Bill does not change existing laws surrounding state medical cannabis programs. Individuals who purchase treatments through a medical dispensary and via a recommendation from their physician are still required to follow the regulations set forth including registration, renewal of medical cards, and other requirements decided by each state.
Should I worry about drug interactions?
The FDA approval and Drug Enforcement Administration (DEA) scheduling of Epidiolex brings to market the first plant-based drug derived from the cannabis plant in the U.S.
Providers do not need a special license or certificate to prescribe Epidiolex. Epidiolex is the first and only plant-based treatment derived from cannabis for use as a treatment for seizures with FDA approval. Other formulations of medical cannabis have not been approved by the FDA.
Cannabis is known by many names – the most common is marijuana. Cannabis is the Latin name used most often by botanists and pharmaceutical companies. The word marijuana usually refers to the leaves and female flowers of the cannabis plant. Medical cannabis is whole plant marijuana or chemicals in the plant used for medical purposes.
This study showed that the addition of CBD to a traditional seizure medication decreased the frequency of drop seizures significantly in children and adults with LGS.
Interim guidance from the ABN states that there is only published evidence for the use of medicial cannabis in Dravet syndrome and Lennox-Gastaut syndrome. Prescriptions should only be for cannabidiol.
A prescription for medicinal cannabis would only be given when all other treatment options have been tried or are considered unsuitable, and would only be given if the doctor considers it to be in your best interests.
Guidance from the Association of British Neurologists (ABN)
While some studies have also suggested that THC may have an anti-epileptic effect, animal studies suggest it can also trigger seizures. There is no evidence from randomised controlled clinical trials for products with higher proportions of THC (more than 0.2 per cent).
“We recommend that these products undergo randomised clinical trials for efficacy and safety before they are routinely prescribed in the UK. We welcome the rescheduling of these products from Schedule 1 to Schedule 2 that will enable their investigation in clinical trials.”
Three double blind randomised controlled trials of pure CBD in children and young people with these syndromes has shown a greater reduction in monthly seizures compared to placebos. There was also a greater reduction in drop seizures in people taking CBD compared to those on a placebo. Further open label studies have shown that it may also have an anti-epileptic effect in the epilepsies in general.