Parents often talk about fighting for the interests of their child, but few will have had to go into battle to the extent Matt and Alison Hughes have for their four-year-old son, Charlie.
As well as facing endless red tape, they’ve spent eye-watering sums of money and were ready to go to the High Court to access medicines that appear to transform Charlie’s health.
Charlie has Lennox-Gastaut syndrome, a rare form of epilepsy that can cause up to 120 seizures a day, causing the little boy to clench his fists and lean forward ‘like someone has hit him in the stomach’.
Those with the syndrome also tend to have learning difficulties — and Charlie is yet to walk with ease, or talk.
Parents often talk about fighting for the interests of their child, but few will have had to go into battle to the extent Matt and Alison Hughes have for their four-year-old son, Charlie
It is a difficult condition to treat and then watch your child deal with.
Charlie was first diagnosed with epilepsy as a tiny baby, and his father Matt, 41, an IT manager from Norwich, admits that he initially thought it was ‘nothing big’.
‘We had no idea how severe and life-changing it would be,’ he says. By the age of one, Charlie was on four different anti-seizure medications. These brought virtually no benefit but came with side-effects, such as lethargy.
‘At playgroup, other parents would say “Look what my child learned to do”, and Charlie would be just lying there like a zombie,’ recalls Matt. ‘It was so upsetting. He had zero quality of life.’
Yet two years ago, Charlie began taking a drug that’s cut his seizures and made him more alert. In fact, the once ‘zombie-like’ Charlie is now nicknamed ‘Tigger’ — ‘On account of how he bounces around the house,’ says Matt.
But there is a problem: the drug is medicinal cannabis. This is thought to help epilepsy by making brain cells less excitable, but it’s not a drug that’s easy to access on the NHS.
Unlike recreational cannabis, medicinal cannabis is grown and processed to pharmaceutical standards and typically comes as an oil or spray containing either cannabidiol (CBD) or tetrahydrocannabinol (THC), which is the psychoactive element of cannabis that causes the ‘high’, although some formulations contain both.
Its production has become a multinational business. Adven, for example, is grown in Portugal, then exported and formulated into oils here.
The drug is medicinal cannabis. This is thought to help epilepsy by making brain cells less excitable, but it’s not a drug that’s easy to access on the NHS
Until three years ago, it was illegal to use medicinal cannabis outside a clinical trial. But after a much-publicised campaign by parents such as Hannah Deacon, whose now nine-year-old son Alfie Dingley’s seizures dramatically improved with medicinal cannabis, the drug was ‘rescheduled’, enabling UK doctors to prescribe it.
Hannah had moved to Holland in order to obtain Alfie’s medication. ‘The day the rules changed, I really thought we were on the verge of something miraculous,’ Hannah, 42, told Good Health.
In fact, little has changed. While Alfie is now able to get the treatment prescribed in the UK, only two other prescriptions for the type of medicinal cannabis he has have been issued by the NHS.
This is despite the health watchdog, the National Institute for Health and Care Excellence (NICE), setting out guidance in March that made it easier to prescribe medicinal cannabis.
So why is medicinal cannabis still so difficult to access? And why does vital research, which could encourage more doctors to prescribe the drug, seem to have been kicked into the long grass?
NHS England says medicinal cannabis can only be prescribed when other ‘treatment options have been exhausted’; and only consultants can prescribe it where ‘clinically appropriate’. Also, many doctors are not keen on prescribing drugs they know little about.
In order to be classed as a medicine, medicinal cannabis must be produced to specific standards. But most products are still unlicensed because they haven’t been subjected to long-term safety trials. It has also not been determined which conditions medical cannabis can be used for, and at what dose.
After a much-publicised campaign by parents such as Hannah Deacon, whose now nine-year-old son Alfie Dingley’s seizures dramatically improved with medicinal cannabis, the drug was ‘rescheduled’, enabling UK doctors to prescribe it
While unlicensed medicines generally are commonly prescribed by specialists, they may be wary of issuing prescriptions for newer drugs they have little training in.
At the moment, just three types of medicinal cannabis are licensed for use on the NHS (see box, right). These include Epidyolex, a pure CBD oil for Lennox-Gastaut syndrome, which Charlie has.
But in late 2018, when Charlie was 18 months old, Alison and Matt were told he wasn’t suitable for Epidyolex, as he had yet to be formally diagnosed.
(Typically, diagnosis is made around age three, when tell-tale electrical patterns in the brain are detectable.)
Despite multiple medications, Charlie’s seizures kept occurring. ‘Every seizure damages his brain and could kill him because it could shut down his brain so he’d stop breathing,’ says Matt.
After a particularly harrowing Christmas, with Charlie having seizures in clusters of 20, his parents began looking for fresh alternatives.
After reading about how medicinal cannabis had helped Alfie Dingley, they tried Charlie on a low-dose CBD oil, bought online. He seemed more alert, though it had no effect on the seizures. In May 2019, they made a private appointment with a London neurologist prepared to write a prescription for two whole plant products, Bedrolite and Bedica (which contain THC and CBD) — the same medication Alfie takes.
(Many unlicensed medicinal cannabis products are whole plant extracts which, as well as THC or CBD, contain other elements of the plant such as terpenes — aromatic compounds that give the plant its taste and smell.)
Some families say these whole plant products work better than Epidyolex, and some studies also suggest they may have a more powerful effect.
Charlie also remained on his other medication (vigabatrin, sodium valproate, clobazam and topiramate); within weeks, his parents noticed a big difference.
‘I remember one weekend — there was beautiful weather and we got to the end of the day and Charlie hadn’t had a single spasm all day,’ says Matt.
‘The next day he had spasms again but they were reduced.’
Matt reels off what Charlie can now do — including sitting up and feeding himself. ‘He can’t stand alone, but he can if he leans against us,’ says Matt.
‘His speech is behind but he makes lots of noises and it’s improving all the time.’
And this week, Charlie started at a special school. He still has ten to 20 seizures a day but they are much less severe, and the family thinks it’s possible Charlie would not have been able to attend the school if he hadn’t been given medicinal cannabis.
‘His quality of life is much better,’ says Matt. ‘He isn’t zombified like he was.
‘Medicinal cannabis doesn’t appear to cause him any side-effects. He’s so cheeky — he’s adorable — we love him so much.’ But going private to get the unlicensed medication doesn’t come cheap. Over the past two years, Matt and Alison, 39, a PA at a structural engineering company, have spent £20,000 funding it.
Earlier this year, after being told that NICE guidelines prevented Charlie’s NHS consultant from prescribing his cannabis medication (despite brain activity tests appearing to show the drug had produced an improvement), Matt and Alison decided to take legal action against NICE, to try to have the guidance changed to make medicinal cannabis more accessible.
Before their case came to court, in March NICE issued a clarification, effectively saying doctors could prescribe the medication in individual cases if they saw fit. Yet it, too, changed nothing.
‘We recently had a meeting with our NHS consultant who would still not prescribe it [medicinal cannabis],’ says Matt. ‘It’s not that they say it doesn’t help; the problem is it isn’t licensed, and if something went wrong, it would rebound on her.’ In other words, the consultant could be vulnerable to legal action if the drug caused problems.
Many families end up looking at medicinal cannabis because nothing else helped. Hannah Deacon says Alfie has been transformed by Bedrolite and Bedica.
‘My son has been seizure-free for 15 months,’ she told Good Health. ‘Before taking [medicinal] cannabis he was having 150 big seizures a week and was in hospital 48 times in 2016.
‘Now he is at school learning to read and write.’
Matt is one of the founders of the charity MedCan, which aims to help families in a similar position.
He estimates there are 60 families in his charity alone paying for private medicinal cannabis prescriptions for their severely epileptic children. ‘A lot of other families are using illegal cannabis,’ he says. In April, a group of 100 cross-party MPs wrote to the Prime Minister warning that families are being ‘emotionally and financially broken’ by the lack of access to medicinal cannabis and called for compassionate funding for them.
Yet even those doctors who are happy to prescribe medicinal cannabis say that it doesn’t work for all.
Dr Sushil Beri, who works at Imperial College London and the Sapphire clinic in London, a private clinic set up to prescribe cannabis, is one of only two paediatric neurologists prescribing unlicensed medicinal cannabis.
He says he takes great care to manage the expectations of parents. ‘Many are desperate,’ he says. ‘Refractive epilepsy [epilepsy that doesn’t respond to medication] is, by its nature, hard to treat.’
And he, too, is also still learning what works. ‘It is the most complex medicine I have had to deal with. It’s a cocktail of botanical elements, and we don’t yet know what they all do,’ he says.
Although specialists believe THC ‘definitely helps’, Dr Beri says: ‘There are safety fears and most of us are rightly concerned about the unknown long-term impact.’
He adds that he sees better results with CBD whole plant extracts than with medications containing CBD alone, such as Epidyolex. Yet while he can prescribe whole plant extracts to private clients, all he can prescribe to NHS patients is Epidyolex.
‘It’s not even available from every paediatric neurology centre, only selected ones.’
The NHS and many senior doctors say there just isn’t yet enough evidence to allow wide access to unlicensed medicinal cannabis products.
‘In animals studies, it [THC] has been found to be both anti-convulsant and pro-convulsant, which underlines the need for more research,’ says Finbar O’Callaghan, a professor of paediatric neuroscience at University College London.
Which cannabis medicines are available?
Medicinal cannabis is a multinational business, with formulations now made here and abroad — but only three brands are licensed for use on the NHS.
These contain cannabidiol (CBD), but in higher quantities than is found in High Street CBD products, or tetrahydrocannabinol (THC), the intoxicating element of cannabis, or sometimes both.
One of the three is Sativex, a spray that contains THC and CBD for the spasticity associated with multiple sclerosis. There is also Epidyolex, a pure CBD oil for Lennox-Gastaut syndrome (which Charlie, see main story, has) and another rare syndrome that causes epilepsy, called Dravet syndrome.
Epidyolex has been available on NHS prescription since September 2019.
The third brand of cannabis medication licensed for use on the NHS is Nabilone, a synthetic form of cannabis, for chemotherapy-induced nausea.
According to a report by the Advisory Council on the Misuse of Drugs there were 328 NHS prescriptions issued for licensed medicinal cannabis products between November 2019 and March 2020 in England — but 288 of these were for Sativex.
This compares with just three prescriptions for the type of unlicensed medicinal cannabis taken by Alfie Dingley (see main story) that the NHS has handed out since 2018.
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He says that he and other paediatric neurologists come under a lot of pressure from parents desperate to get cannabis prescriptions for their children.
‘But these drugs aren’t licensed and we aren’t comfortable prescribing it,’ he says, adding that large-scale trials are needed.
‘Medicinal cannabis is a drug like any other and it should be tested to make sure it’s effective and not doing any harm,’ he says.
‘That’s not to say that I don’t hold out hope that these drugs may be effective and safe.’
Most drugs are licensed only after randomised control trials, where the drug is given to one group and a dummy to another. But parents whose children are already doing well on medicinal cannabis — like Joanne Griffiths, a mother-of-six from Preston — say they fear the consequences if their child was given the placebo.
Her son Ben, 12, has epilepsy as a result of cerebral palsy. Aged five he was on four medications and still having 80 to 100 seizures a day. In 2018, a friend illegally brought back medicinal cannabis oil containing THC and CBD after visiting a medical clinic in Canada.
‘We gave Ben one drop in the morning and one at night, and we were like “Wow, he’s hardly had any seizures” ,’ says Joanne.
With the support of their specialist, they continued with the oil, but by September 2018 they had run out. They begged for compassionate access to Epidyolex, which was granted in October 2018.
‘Yet by December, he was in hospital having up to 300 seizures,’ says Joanne.
Then, in March 2019, a neurologist at the private Portland Hospital in London prescribed Bedrolite and Bedica, for which Joanne, 45, and husband Paul, 41, manager of a window company, pay £1,900 a month. Ben now has few seizures.
‘Ben could end up being given a placebo in a trial — why would you make your child suffer when he is doing really well?’ says Joanne.
While longer-term studies are carried out, Matt and Hannah Deacon want the NHS to take into account the effects doctors and patients see for themselves.
In April 2019, a review set up by Matt Hancock, the then health secretary, suggested a faster ‘alternative study’ but last year campaigners were told the plan was to revert to a randomised control trial. The Department of Health told Good Health it is working with NHS England and others to set up clinical trials and would be able to confirm details of the type once a ‘supply contract’ had been established.
Meanwhile, Matt and Alison pray they can keep sourcing the prescriptions when Charlie’s private consultant retires this month.
Charlie has switched to a cheaper product, Celixir20, but even this costs £650 a month. He is on two anti-seizure drugs but his parents hope to wean him off these because of their side-effect, tunnel vision.
At times, Matt sounds tired of fighting. ‘There are times I want to quit,’ he says. ‘But if I don’t do this, who will? I’m not just doing this for Charlie but for those with similar difficulties.’
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