It has had a life-changing effect for Charlie, after he began courses of the medicine in May 2019. He can feed himself, shows greater interest in his toys, and is far more vocal than before, though he remains unable to speak or walk.
Charlie Hughes. Photograph: Family handout
The high court judge paid tribute to the “dogged persistence” with which the Hugheses had sought “what they believe to be the best, and safe, treatment for their son and the rare and serious condition from which he suffers”.
“No one knows definitively what effect all those anti-epileptic drugs in combination with each other have on the development of the brain. If he wasn’t asleep or completely zonked out, he was just seizing. Cannabis has massively improved his general wellbeing.”
He said: “Nice has argued that the guidance is clear and that there is nothing stopping the NHS from currently prescribing cannabis-based products. Perhaps a successful outcome for the claimant will lead to clarity over this, or generate momentum for prescribing in the claimant’s particular case.”
Cannabis oils available in the UK and on the internet are not regulated medicines so their contents and dosage will not be consistent. People must always speak with their specialist epilepsy consultant if they are considering any alternative treatment including cannabis oil.
Containing less than 0.1% THC, pure cannabidiol (CBD), has been prescribed in certain circumstances, and through clinical trials has been shown to be effective in complex epilepsies, more specifically Dravet syndrome and Lennox Gastaut syndrome. These findings have been submitted with a view to gaining a licence. There is no evidence about the efficacy or safety of higher amounts of THC.
The effects of cannabis on epilepsy have been under discussion for a number of years and the current interest in the case of Billy Caldwell has highlighted this even further.
Cannabis has long been thought to have therapeutic properties. Cannabis products contain a substance called THC; the component that causes a medical high. In the UK there are laws regarding the amount of THC in cannabis products which are only legal if they contain less than 0.3% THC.
The Government has defined a cannabis-based product for medicinal use in humans as one that:
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.
What is medicinal cannabis?
The BPNA also recommends that where children are already taking other cannabis-based products that contain higher proportions of THC, they should be transitioned on to CBD until strong evidence for these products can be produced through clinical trials.
The body also has concerns about the ‘viability of the economic model’ used by GW Pharma, the company that developed the drug, to establish the cost to be charged to the NHS for it. It concluded that Epidyolex would not, at this stage, be an effective use of NHS resources.
People always have the option of seeking a second opinion.