Cannabis oil for epilepsy – what you need to know
In around one third of people with the disorder, epilepsy medications don’t work well, or at all. Unfortunately, these epilepsy tough to treat is associated with an increased risk of premature death.
Anecdotal evidence indicates that cannabis oil may help some of these individuals control their seizures and save their lives potentially. A small number of studies have shown that the addition of cannabis oil to existing medication may be effective in children and adolescents with devastating, hard-to-treat epilepsy.
One such person is Billy Caldwell, 12. Billy was in the news recently after authorities confiscated the cannabis oil prescribed for him at Heathrow airport. Billy ‘s mother, Charlotte, was trying to get the cannabis oil from Canada into the UK, where cannabis oil is legal.
Billy was seizure-free for more than 250 days while taking the drug, but when his cannabis oil was removed, his seizures began again. The home secretary, Sajid Javid, was persuaded to intervene and returned one of the seven cannabis oil bottles with a 20-day license to administer the drug.
Similarly, in the Netherlands, six-year – old Alfie Dingle, who suffers from severe epilepsy, had been treated successfully with cannabis oil. Hannah Deacon, Alfie ‘s mother, has campaigned to allow her son to get cannabis oil in the UK.
In the case of Alfie, the government has now also relented following the concerns raised around the confiscation and return of the medicine of Billy Caldwell.
What the evidence shows
So what do we know about cannabis oil and its effects on epilepsy seizures?
THC (tetrahydrocannabinol), and CBD (cannabidiol) are the two main constituents of cannabis oil. Oil containing CBD alone (CBD oil) can be legally purchased in the UK without a prescription, since it contains only very small amounts of THC. But it is illegal to use cannabis oil with THC at higher levels (more than 0.3 per cent). THC is a drug on schedule 1, meaning it is deemed not to have any medicinal value.
The reason Billy’s cannabis oil was seized at Heathrow airport was because it not only contained CBD but also contained THC at higher levels than legally allowed.
Robust human clinical trials show good evidence that CBD is beneficial for specific epilepsy, such as Dravet syndrome and Lennox Gastaut syndrome. An advantage for the pharmaceutical industry is that the drug development can be quickly tracked for these rare diseases without any cure. On this basis, it is widely expected that the U.S. Food and Drug Administration will grant a license to treat these epilepsy for CBD (under the tradename Epidiolex). If so, it’s likely that Epidiolex will be available in the US by late 2018. It is probable that European approval follows.
It should be noted that Epidiolex is designed with pure plant-derived CBD as a standardized oral solution. It is not the same as non-standardized, viscous CBD oils which contain varying amounts of CBD and can be bought at health food shops. There is currently no clear evidence that CBD oil (or indeed cannabis oil) formulations are as beneficial for seizures with epilepsy. Likewise, there is no conclusive proof – merely anecdotal accounts – that THC helps minimize human seizures of epilepsy.
THC has weak overall effects in reducing seizures in [animal studies], and has also been shown to be less effective than CBD anticonvulsant. THC, being a psychoactive substance, also has a number of side effects, including the well-known euphoric “high” associated with recreational use – a significant disincentive for the pharmaceutical industry to develop a medicine containing that compound.
We now have to determine whether to extend human trials with a better specified cannabis oil containing THC, or whether to rely on CBD. The fact that Epidiolex has advanced toward approval in the United States may encourage the latter. CBD lacks THC-related psychoactive effects, and is usually considered a healthy drug.
If regulatory approval is granted to Epidiolex, it will also need to be monitored in a larger number of patients-in what is known as “phase 4 post-marketing surveillance”-to ensure it is safe and effective in a larger population. Only large-scale clinical trials will provide conclusive answers regarding effectiveness and safety for any cannabis related drug.
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