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Parents of toddler with severe epilepsy seek legal review of cannabis oil guidelines

The parents of a toddler with severe epilepsy are seeking a landmark judicial review of rigid guidelines that effectively prevent the NHS from prescribing medical cannabis oil, a substance that they say has allowed their son to live a much healthier life, to thousands of sick children.

Charlie Hughes, 3, has a rare form of epilepsy called West syndrome, which is resistant to most forms of treatment and can cause him to have up to 120 seizures a day, according to his parents, Alison and Matt Hughes. With regular full extract cannabis oil, however, he experiences no more than 20 less severe seizures a day.

The NHS has prescribed him seven different anti-epilepsy drugs, including benzodiazepines, which largely left him dazed, lethargic, and still regularly having 100 seizures a day. He has almost been entirely weaned off those drugs.

Matt Hughes, an IT manager who founded the information forum MedCan Support, said cannabis oil had transformed his son’s life and questioned why some dependency-forming drugs with debilitating side-effects were not subject to the same rigid prescribing guidelines that make them effectively unobtainable.

His family, who live in Norwich, pay hundreds of pounds a month to source cannabis medicine privately because clinicians at two NHS trusts refuse to prescribe Dutch-made oils, even though they are produced according to the European Medicines Agency’s guidelines for good manufacturing practice.

The Hughes family. Photograph: Handout

Full extract cannabis oil is legal for medicinal use but remains unlicensed for prescription in the UK, but it is not uncommon for unlicensed drugs to be prescribed. It contains both CBD and THC, the psychoactive component of cannabis that adds regulatory hurdles and burdensome import processes, which increases costs.

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.

The family is receiving legal aid for the action at the high court against the National Institute for Health and Care Excellence (Nice), which sets prescribing guidelines for the health service.

On 30 July, Mr Justice Holman granted the Hughes family permission for a judicial review in Charlie’s name against the Nice guidelines on the basis of “alleged inadequate consultation” and an “alleged failure to take into account relevant considerations,” court documents show.

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”.

The Hugheses will argue that the current evidence, despite much of it being anecdotal and low quality, should be enough to at least support modest recommendations for doctors to consider cannabis oil for severe cases of treatment-resistant epilepsy.

Lawyers will suggest that Nice have not adequately considered the appraisal of the chief medical officer for England, Sally Davies, that there is “conclusive evidence of the therapeutic benefit of cannabis-based medicinal products for certain medical conditions [including epilepsy]”.

As cannabis is not a single-molecule medicine, the effects of which may be less easily assessed in randomised control trials (RCTs), a more flexible and pragmatic approach to ascertaining its apparent real-world efficacy should be considered, it will also be argued.

The health watchdog has acknowledged the need for more research to build the evidence base for the use of cannabis medicines, and supports NHS England’s call to collect evidence from both RCTs and observational studies. It maintains there is not clear evidence of the safety and effectiveness of cannabis oil, which is available through public healthcare systems in several G20 countries.

Charlie Hughes. Photograph: Family handout

Specialist doctors can prescribe it – after weighing up patients’ circumstances, clinical condition and need – but there is significant resistance among some clinicians. It is also understood that some trusts have effectively blocked attempts, while other doctors are known to be waiting for an official green light as the private market booms.

If the review is successful, then the family will seek for the guidance to be redrafted. This could be significant, experts say, potentially emboldening some doctors to insist on the prescription of Dutch or Israeli oils that have not gone through all requisite regulatory hurdles in the UK. It would not make its prescription obligatory, however.

Hughes said of his son’s improvement since taking cannabis: “Charlie is happier, more alert, far more vocal, constantly babbling and takes an interest in his toys. He can feed himself and loves nothing more than some rough and tumble with me. He’s come alive again.

“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.”

With regards to cannabis-based medicines available on the NHS for epilepsy, Nice recommends just Epidyolex for two rare syndromes of the condition. Because of European Medicines Agency recommendations, it must be taken in conjunction with Clobazam, a benzodiazepine that some parents have said can cause troubling side-effects including hallucinations and amnesia.

Prof Harry Sumnall of Liverpool John Moores University said the review, if upheld, could provide welcome clarity over whether NHS doctors can prescribe medicinal cannabis. He remained mindful that high-quality evidence of its benefits was still lacking.

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.”

Nice, which was given 35 days to contest the claim, said it would not comment as legal proceedings were ongoing. The hearing could be heard by the end of the year.