Too much pain? The Price of Politics in the treatment of childhood epilepsy

By Rayyan Zafar an Honorary Research Assistant for Drug Science

It was 5 years ago in 2016 when Nick Clegg, the then deputy prime-minister of the United Kingdom became aware of a group of patients suffering with the severe nerve-wasting syndrome, multiple sclerosis, who were using cannabis to treat their condition. He heard accounts of patients reporting how the stiffness of their joints and their pains were resolved after using this illegal drug. There was no denying the patient testimonials and how their lives had been transformed by cannabis and so Nick Clegg set off on a mission to convince Members of parliament of the therapeutic utility of this drug. Not soon after and following a public interest campaign, the group ‘End our Pain’ was formed to represent patients that required access to these illegal, yet transformative treatment.

Several years passed with the End our Pain group lobbying for patients right to access these medicines, yet it was not until the now infamous case of Alfie Dingley that the medical cannabis movement in the UK really began. Alfie, a 9-year-old boy, who was suffering from a rare genetic form of epilepsy leading to up to 150 seizures a week found his condition significantly improving when he was given medical cannabis. Alfie’s case was placed front and centre of the campaign that eventually led the British government on the 1st November 2018 to legalise medical cannabis treatment and the first specials prescription was written. As a result of this highly successful media campaign, 20 similar families came forward to share their stories of successfully treating their children’s condition with cannabis, demanding they received their now-legal NHS prescriptions. Cannabis, a medicine used for millennia was rightfully restored into the British pharmacopoeia and could now treat and help keep children, who otherwise might have died, alive.

In reality, the change in law in 2018 amounted to little more than lip-service. Following the statement issued by Theresa May and the then home secretary in support of the new legislation, a series of guidance was swiftly issued by the NHS, NICE, BPNA and the GMC. The guidance effectively restricted the prescription of medical cannabis on the NHS to a limited number of child patients – to be precise, a total of 3 since 2018, in spite of the 26,000 children suffering with refractory childhood epilepsy in the country today. In the early days following the enactment of the law assurances were provided to families that they would gain access to these medicines. Ultimately what entailed has been a cruel and callous two years of broken promises.

In March 2019, the secretary of state for the department of health, Matt Hancock, met with the families who were paying up to £2500 a month for private prescriptions and empathised ‘I know you cannot wait any longer’. He assured them that within two weeks he would find a solution to help them gain access to these medicines in the NHS. Unsurprisingly, Matt Hancock failed to deliver. The family’s pleas fell on deaf ears with a marked radio silence from the department of health. There was a brief glimmer of hope when it was announced in parliament that the government intended to enrol these kids on an NHS sponsored observational study in order to get them their medicines for free. These families were led to believe for a year that this was being set up until they were told with no explanation that the plan had been discontinued.

It was following the retraction of the promised observational study that Drug Science decided that decisive action was needed to both collect evidence on the therapeutic success of these medicines and to disseminate critical research to change the restrictive guidelines. If they weren’t going to do their job, then we had to.

We began to collect evidence on what the impact of medical cannabis was on their seizures, quality of life and their journeys in accessing these medications. In our newly published article in Drug Science, Policy and Law, you can read these ground-breaking findings.

Throughout this time, all patients had been using the Dutch medical cannabis products Bedica and Bedrolite, which are composed of varying ratios of CBD and THC. These are unlicensed medicines in the UK meaning that only specialist doctors can prescribe them and there is no support or guidance from NICE for combined CBD and THC to be used in this condition.

Our findings showed that medical cannabis improved the children’s quality of life, mood and behaviour. Most importantly, we found across the group an average 97% decrease in the numbers of monthly seizures. These are amongst some of the largest reductions in seizure reported due to medicine in childhood epilepsy, greatly surpassing the effectiveness of mainline licenced epileptic medication. Our results demonstrate the clear therapeutic potential of medical cannabis for children suffering with these conditions.

The impact of the pandemic has exacerbated the great financial burden placed on furloughed families who struggled to raise money leading to them running out of their medical cannabis. This led to one of the children ending up in GOSH paediatric intensive care unit having slipped into status epilepticus and having to be provided life support.

The government, NICE and the regulatory bodies [DHSC and Home Office] have systematically obstructed the path to free NHS prescriptions and now any such prescription at all has been denied.

Yet things got much worse for this group. In a letter sent out on the 17th December 2020 to all UK importers, clinics and several patient groups, the Department of Health stated that due to the end of the Brexit transition period, prescriptions issued in the UK can no longer be lawfully dispensed in an EU Member State.  This means that the supply of medical cannabis from Holland, which around 40 severely epileptic children and their families are completely reliant on, will be terminated. Many of these children are only several weeks away from running out of reserve supplies of their medicines. Some children as young as 22 months old. Once these medicines run out it is very likely their condition will severely deteriorate and in the worst-case scenario, they could die.  This development after two years of tirelessly and unsuccessfully campaigning and raising money for their legally entitled medicines must rank amongst one of the grossest acts of regulatory oversight ever seen in the UK.

Drug Science and the affected families with MPs on the all-party parliamentary group for medical cannabis and the national press are now lobbying for Downing street to make the call to their Dutch counterparts. It is now their responsibility to ensure these children’s whose lives have barely begun don’t become the first unwitting causalities of a post-Brexit Britain. The governments must now decide whether using our children’s lives as bargaining chips for sovereignty is the game they wish to play.