A dad can't afford to keep his epileptic son alive after being forced to pay £1,000 a month for lifesaving medical cannabis. Matt and Ali Hughes' son Charlie was born with a catastrophic form of epilepsy called infantile spasms.
He had 120 seizures a day and the NHS told the couple they were out of options for treatment until they found medical cannabis privately. The first-ever respite came for the Hughes' after Charlie was prescribed the medical cannabis Bedrolite from Holland.
Charlie, now five, is at school and is reaching milestones the couple never thought possible. However the cannabis isn't available on the NHS.
Due to a clarification from the Medicines and Healthcare products Regulatory Agency (MHRA) the couple can no longer afford to pay for the lifesaving drug. IT specialist Matt, 43, said: "I feel broken. I haven't slept at all.
"We're just trying to get our heads around it and figure out what to do next. Within six months of Charlie starting Bedrolite two years ago, there was an 85 per cent decrease in Charlie's seizures.
"His quality of life had transformed on this drug. For the first time he was alert, awake, he was coming back to us.
"He was interacting with us in his own way, with conversations and his surroundings. Now his life is in danger because the MHRA won't allow us to get any cheaper version of the drug."
Medical cannabis is a broad term used to describe oils, tablets and sprays that include cannabis and are made by pharmaceutical companies. At 10 weeks old Charlie started spasming, which quickly turned into nearly constant seizures.
After trying seven different medications, a keto diet and exploring the option of brain surgery, the Hughes' were out of options until they found medical cannabis. Having started on Bedrolite which costs £1,000 per month, they then switched to a cheaper medication for £600 a month called Celixir20 from Israel.
On Jan 3 the Hughes' were told their private physician will no longer be prescribing Celixir20 due to the MHRA forcing him to take full liability for the drug. This is because Celixir20 is made to Israel's health standards rather than EU.
Now the Hughes' are faced with the prospect of taking their son off the drug which has transformed his life because they can no longer afford the more expensive version, Bedrolite. Charlie's seizures would return which can cause damage to the brain.
Matt said: "I cannot put into words how it feels. My wife is still impacted by how difficult things used to be before medical cannabis. Her mental health went downhill, she can't stand seeing other children have seizures or go to hospitals.
"Charlie is nearly walking, he is learning at school but this could end as the seizures wipe his memory. Next year he will be back in intensive care if things don't change."
The couple has already moved into a bungalow to help with Charlie's access needs, getting a bigger mortgage and paying for private therapies. The Hughes' launched a legal challenge against the National Institute for Health and Care Excellence (NICE) after their NHS clinicians were unable to prescribe the drug.
According to NICE, there is not enough evidence to prescribe cannabis-based medicines for severe epilepsy. After the Hughes' legal challenge, NICE clarified the guidance to add there was "no recommendation against the use of cannabis-based medical products".
The British Paediatric Neurology Association (BPNA) then produced further guidance which Matt describes as a 'zero tolerance approach' to prescribing cannabis. Matt said: "Doctors are too scared to prescribe.
"The NHS and BPNA should be considering a harm reduction approach to prescribing unlicensed cannabis medicines rather than forcing families to other routes. As a parent I feel completely helpless. We are in absolute despair."
Matt has since established the community interest company Medcan, supporting families like his going through the same thing. He helps to raise money for families struggling with the costs of buying private medical cannabis and offers support in making informed decisions.
The organisation also runs research projects on the efficacy of medical cannabis. They also offer mental health support to the 600 families they support, some of whom struggle with anxiety, depression and Post-Traumatic Stress Disorder due to their experiences.
A spokesperson for NICE said: "Until there is clear evidence of the safety and effectiveness of cannabis-based medicinal products, specialist doctors need to consider individual patient circumstances, clinical condition and need, and to weigh up, with the patient or carer, the relative risks and benefits in choosing treatments."
MHRA chief healthcare, quality and access officer, Dr Laura Squire, said: "We recognise the importance of these cannabis oil products for children with severe forms of epilepsy. That is why we have enabled continued patient access to them by accepting applications to import. No parent should have cause for concern about ongoing supplies.
"We continue to work with the importer of Celixir20 to try to resolve concerns about non-compliance with UK standards.
"Whilst the current agreement extends to the end of this year, this timeline will be extended should it prove necessary in the interest of individual patients' health."
