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BPNA publishes new guidance on prescribing medical cannabis in epilepsy

The updated guidance has been described as ‘unethical’ by medical cannabis experts.

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The BPNA has been accused of trying to “block private access” to cannabis-based medicines

New guidance published this month by the BPNA on the prescribing of medical cannabis, has been described as ‘unethical’ by experts.

The British Paediatric Neurology Association (BPNA) this month updated its guidance for clinicians on the prescribing of cannabis-based medicines for children and young people with epilepsy.

It’s the first time the framework has been updated since 2018 and comes following the amendments to the NICE guidelines earlier this year, clarifying that clinicians can prescribe medicinal cannabis in appropriate cases.

The BPNA’s view that it must be a paediatric neurologist who prescribes, is not supported by national guidance, with the Medical Cannabis Clinicians Society (MCCS) recently highlighting that it is “legal and acceptable” for a paediatrician with an interest in epilepsy to prescribe, under a shared care arrangement with a trained cannabis physician. 

This, along with its insistence that there is “no evidence” for the safety and efficacy of medical cannabis products and “concerns” about the effect of exposure to THC on the developing brain, is widely blamed for the lack of access to NHS prescriptions for children with epilepsy. 

Blocking private access

But while many would hope any new guidance would make things easier for doctors wishing to prescribe cannabis-based products, the BPNA has been accused of making things worse for patients and even trying to “block private access”, as well as that through the NHS.

The BPNA has now put the onus on the prescribing doctor to ensure families can afford to carry the financial burden of accessing this medicine privately.

“If a paediatric neurologist prescribes an unlicensed CBPM in private practice they should also be certain that the family can sustain the cost of ongoing private prescriptions,” the BPNA states.

We consider it unethical to initiate a treatment in private practice for which funding is not available in the longer term. The NHS is unlikely to meet the cost of future prescriptions of an unlicensed medicine that has no Level 1 evidence of efficacy and safety.

It comes following reports of parents being forced to sell their home and rely on fundraising to pay for these medicines privately, an average cost of £2,000 per month.

The Medical Cannabis Clinicians Society (MCCS) has slammed this move as “totally unacceptable” and accused the BPNA of driving patients to the black market with its “outdated” stance. 

Professor Mike Barnes

Its chair, Professor Mike Barnes, told Cannabis Health: “It is not in any way standard practice for a doctor to enquire whether a family can support funding in the long term. Such an inquiry is unethical and such a situation would of course not arise if a doctor prescribed it on the NHS, as is legal. 

“The stance of the BPNA is driving patients and their families into private practice and in some cases into the black market.”

Hannah Deacon, director of the MCCS and mother to Alfie Dingley, agreed, saying this would leave patients denied access in every avenue. 

“The BPNA now appears to be trying to shut down private access as well as NHS access,” she said.

“This new guidance is placing all the onus onto the private doctor to be responsible for ensuring that families can afford to pay for the prescriptions before they’re issued. There would be no way that any private doctor would do that for any other medication. This guidance causes harm and all it’s going to do is push people to the black market.”

Real world evidence

The BPNA claims that the prescribing of cannabis medicines is “largely untested”, despite the fact that there are now over 10,000 patients prescribed for in the UK including around 200 children with treatment-resistant epilepsy. 

The MCCS also points out that there is a “significant volume of efficacy and safety data” in the form of real world evidence. 

Members of the BPNA have been trained in the prescribing of pharmaceutical products which have RCT data behind them,” Deacon said.

“What we would urge them to understand is that this is a botanical medicine with many hundreds of compounds which cannot go through the randomised control trial process effectively, and real world evidence very much has its place here to prove safety.”

The impact of not prescribing

Prof Barnes added that the new guidance has failed to recognise the “downsides of not prescribing” which include a poorer quality of life, brain damage and even death.

“There is no recognition of the fact that these children have uncontrolled, drug resistant epilepsy by definition. They have a poor quality of life, often difficulties in school and in play and at home and the whole family suffers from the consequences,” he said.

“Recurrent seizures are damaging to the developing brain and such severe seizures are associated with a risk of status epilepticus and death. Every avenue must be explored in an attempt to alleviate the seizures. Cannabis is not a cure-all and is not the right medication for every child (or adult). However, it has been shown to have efficacy in many cases and is generally remarkably safe.”

Advocacy

My daughter’s seizures reduced by 95% on medical cannabis – why is it not available on the NHS?

Clover Carkeet’s family have had to fight for her to maintain access to the treatment

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My daughter’s seizures reduced by 95% on medical cannabis
Emily Carkeet with her three-year-old daughter Clover

Three-year-old Clover Carkeet’s seizures have reduced by 95 per cent with medical cannabis – so why has her family had to fight so hard to maintain access to it?

Clover had her first seizure at just 12 weeks old. Doctors diagnosed her with infantile spasms, a ‘catastrophic’ form of epilepsy that is among the most brain-damaging conditions of its kind. 

Early signs of the condition were discovered when her mum, Emily Carkeet, was 30 weeks pregnant. 

She was told that Clover was missing the part of her brain that connects the left hemisphere to the right, known in medicine as the corpus callosum. 

Seventy five per cent of newborns with the condition will grow up to live completely normal lives, but sadly Clover is among the minority that develops neurological issues from early childhood.

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Like many children diagnosed with rare forms of epilepsy, Clover was started on a heavy dose of steroids which she took for six weeks. 

“It was a really awful time for us,” Emily recalls. “They made her extremely poorly. She was so upset and angry. She was basically just staring into space.”

After the steroids, Clover was started on a strong antiepileptic drug called vigabatrin, with her enjoying five months without seizures. The freedom gave her the chance to develop, and even learn to crawl.

My daughter’s seizures reduced by 95% on medical cannabis

Spencer, Emily and Clover Carkeet

Trying CBD

But it wasn’t just the vigabatrin that was aiding her recovery, Emily believes. 

When Clover was four months old, her parents began giving her tiny doses of over-the-counter CBD oil called Hayleigh’s Hope. In the early days of Clover’s diagnosis, Emily had connected with hundreds of families whose children suffered from similar conditions.

“I was always searching for the answers for Clover,” Emily says. 

“I found that the children who were taking some form of CBD all seemed to be developing fairly normally. Their seizures were well controlled and they were spending less time in hospital.”

She continues: “Every time we increased her dose she would learn something new, physically her development was ahead of some of her neurotypical peers, she crawled at nine months and walked at 13 months, all these things that they said she wouldn’t do.”

But after five months Clover relapsed and developed something called focal seizures. Despite increasing her pharmaceuticals, her condition worsened until she was having as many as 100 seizures a week.

95% reduction in seizures

At this point, Emily and her partner, Clover’s father, Spencer, were at a “crossroads”. Either introduce more pharmaceutical medication or pursue a CBD prescription.

“It became abundantly clear that what we could buy over the counter just wasn’t strong enough for her,” Emily says. 

“We were at a crossroads really; we could either add more meds… but we had made a vow in those early days that that was not what we wanted for her. We wanted to give her a chance to have a quality of life, and we believed the best chance of that was by staying as far away from heavy duty drugs as possible. 

“That’s when we decided to go down the prescription route.”

Clover met criteria and was able to access a legal prescription for medical cannabis in August 2020. By November, her seizures had dropped to just three or four per week – a 95 per cent reduction. 

The following April, the family added the THC-containing oil Bedica to Clover’s course of medication, which is when the number of seizures fell “dramatically”.

“THC was the game-changer for her. She was sometimes going 10 days without a seizure,” says Emily.

“The biggest doubt for me was that THC might have detrimental behavioural and developmental effects, it worried me, but less than having her on a benzodiazepine, wired up to machines in hospital. As her mum I’ve always followed my gut instinct.”

My daughter’s seizures reduced by 95% on medical cannabis

Clover’s parents say THC was a “game-changer” for her

Battling the BPNA 

Despite Clover’s parents seeing a huge improvement in her condition and quality of life, the family faced losing her access to the medicine when her prescribing doctor was reported to the General Medical Council (GMC) last year. 

Although she doesn’t know the details of how it came about, the complaint was made shortly after Emily wrote to Clover’s neurologist in the NHS outlining her daughter’s positive response to cannabis-based medicines. 

The complaint, believed to have come from the British Paediatric Neurology Association (BPNA), centred around Clover’s age as at the time, at 17 months old, she was the youngest child in the UK to be prescribed the medicine. It stated that the doctor was not a neurologist and therefore should not be prescribing. 

BPNA guidance claims that cannabis medicines can only be prescribed in children with epilepsy by a paediatric neurologist. But this is not stated anywhere in current legislation. 

The case ended up being dismissed, with the GMC’s independent medical expert quoted during the review as saying the BNPA position is “probably not in the best interests of children”.

“Doctors sign a Hippocratic oath then they don’t do what’s best for their patients. It’s very negligent to deny these kids a medicine that clearly works for them,” says Emily.

“What I don’t understand is this necessity to throw so many drugs at them just because they’re licensed.

“In my opinion – and logic should rule here – if a child finds something that works, why would you then force them to go back and try all these other things that may be detrimental to them? I find this concept of using cannabis as a last resort absolutely crazy.”

Emily believes that the BPNA guidance on medical cannabis is part of the reason why NHS access is so limited for children with epilepsy.

“They complained about Clover and made no effort to speak to me about how she was doing at all. They don’t listen to us as parents, even though, when you’re a parent of a child with epilepsy, you become the expert on their condition,” she says.

“It’s just so wrong on so many levels.”

Emily and Spencer, with Clover, on their wedding day recently

A “constant juggling act” 

Clover is doing well developmentally and starting to communicate more as she reduces her prescription drugs, something Emily puts down to the medical cannabis. 

“I had read about neuroprotective benefits from cannabis and genuinely think that because she’s had it in her life since she was so young, it’s probably protected her brain,” she says. 

“We’ve never seen any regression from any of her seizures and I honestly think it’s the cannabis we have to thank for that.”

She attends nursery and Emily has been able to return to work. Something which has been a lifeline in funding Clover’s prescription, which currently costs around £1,000 a month. 

Emily and Spencer are able to fundraise, but still pay £600 each month out of their own pockets. Emily describes the situation as a “constant juggling act”.

“I feel an extreme pressure to be working more than I am because we have this prescription to pay for,” she says.

“The person who suffers from this is Clover because she doesn’t get as much of her mum as she needs.”

But despite their struggles, Emily feels lucky they have access to the treatment when so many families in the UK are unable to obtain a prescription even privately. 

There is currently only one paediatric neurologist prescribing for children with epilepsy in the UK, and he is not currently taking on any new patients. 

“There are so many parents who are desperately trying to get this medicine, because they see the results,” she adds.

“It’s an injustice that they can’t access it.”

 

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Support secured for Scottish medical cannabis debate on behalf of 9-year-old Cole Thomson

An MSP has secured cross-party support for the first debate of its kind in Scotland.

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Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis
Cole Thomson has been seizure-free since 2019

An MSP has secured cross-party support for a members debate on access to medical cannabis, on behalf of nine-year-old Cole Thomson, who relies on the life-saving treatment.

Collette Stevenson MSP for East Kilbride has secured cross-party support after submitting a motion for a members debate on access to medical cannabis for drug-resistant epilepsy.

The motion is now considered eligible for debate, and will be the first of its kind to take place in the Scottish Parliament.

It comes as Ms Stevenson has been supporting the family of Cole Thomson, who has been seizure-free since 2019 thanks to medical cannabis, in their campaign for NHS access. The debate will help highlight the various issues the family has faced in funding the treatment. 

“The first time Cole had a seizure, it was 2012, and he was three and a half months old. He was in my arms, and suddenly his eyes widened like something had come into view. It would have been easy to miss, but as I was already mum to a two-year-old I knew something wasn’t right,” says mum of nine-year-old Cole, Lisa Quarrell, who pays £1,300 a month for her son’s life-saving whole plant cannabis oil prescription.

“Cole’s dad, David, put it down to me being an overprotective mother, but the following day Cole did the same thing again and by the end of the week I managed to film him doing it 10 times. It was obvious something wasn’t right, so I took him to the doctors.”

Every parent’s worst nightmare

After taking blood tests, urine samples and having a thorough check over, Cole’s GP deemed him to be perfectly healthy. That’s when Lisa showed him the video, and his face dropped.

“We were told to go straight to the hospital,” Lisa continues.

“When we got there, the nurse made out like these spasms were totally normal, but when the paediatrician saw it happen she told us it could be West syndrome – a condition where both sides of the brain malfunction. I was terrified.”

Cole was taken to Glasgow Children’s Hospital, where Lisa was given the news that is every parent’s worst nightmare: the best case scenario was that Cole would live, but be severely disabled. 

The worst case was that he would die before he was five-years-old.

“We couldn’t believe it, until a week ago we had a three-and-a-half-month old baby who was perfectly healthy,” says Lisa.

“We were living in a bubble at that stage because when you’ve got a new baby everything is amazing and new. Then ‘boom’ our whole world was turned upside down.”

After four weeks of waiting, desperately trying to not live in the awful reality they were now faced with, Cole’s results came back. He had focal epilepsy, which meant the tissue was damaged on the left side of his brain. 

He was given a two week course of strong steroid medication, in the hope that once he was weaned off, the seizures would stop.

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole began having seizures at just a few months old

But devastatingly, they became worse. What had been infantile spasms, became full focal seizures. His little body would go rigid, his breathing would become heavy, and he would make repetitive clicking noises until the seizure passed.

From then on, Cole had three to four major seizures a week and was tried on nine different anti-epileptic medications, all of which came with negative side effects, and none of which helped. 

When he was 18 months, Cole’s consultant told Lisa and David that as the drugs weren’t working, brain surgery was the next step.

“Both Cole’s dad and I were against it, but we went for all the meetings and then his seizures suddenly got really bad, so we started the process for brain surgery,” says Lisa

Cole had a left temporal lobe lesionectomy, and had a two centimetre squared area of his brain removed. 

Although he recovered quickly with no side effects, the seizures came back six months later. 

Sadly, this meant that Cole was a candidate for a second brain surgery that would be much more serious. The damage was near his vision and movement and speech. If they cut any more away it could leave him paralysed.

But, in June 2018, everything changed.

Desperate for a solution

“Cole was having 12 seizures a day, his speech was slurred and his walking was affected. The doctors had said there was nothing else they could do. I was desperate,” recounts Lisa. 

“That’s when I put a plea out on social media. I was looking for any solution other than surgery.”

Lisa created a Facebook post asking: “is there anything anywhere in the whole world that you think could help Cole? I don’t care what it is or how much it costs, I’ll do anything I have to to get my boy better.”

Every response came back saying “cannabis”.

Lisa wasn’t convinced. Having been a police officer for a decade until 2013, her understanding of cannabis was extremely negative. 

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole, before and after cannabis

“I was blindsided, I thought cannabis was a demon,” she admits.

“I remember saying ‘I’m not putting my son on cannabis. It causes psychosis, withdrawal, mental health problems, it’s a gateway drug’ – everything that people who are ill-informed think.”

But then Lisa started to research, not because she wanted to see how good it was, but because she wanted to find evidence to back up what she now knows to be misguided views. 

“I wanted to prove it was nonsense, but anything negative I saw just happened to be a study performed by a pharmaceutical company, a religious group or anti-drug organisations,” she says.

“There was never a scientific view that was against cannabis, it was all very positive.”

In October 2018, Cole took a turn for the worse and began suffering from Todd’s paralysis, a neurological condition in which a seizure is followed by a brief period of temporary paralysis.

“Cole would come out of a seizure and be paralysed. He was confused, unable to sit up, he would wet himself,” says Lisa.

“It would last about an hour at first, then it progressed until he would be paralysed all day. I couldn’t work, I couldn’t take my other son to school, it was like living in a nightmare.” 

That’s when Lisa took the plunge and began treating Cole with an over-the-counter, full-spectrum CBD oil, recommended by the Kalapa Clinic in Barcelona. Within three days the paralysis had completely gone and his seizures decreased from 12 to nine a day.

Seeing such incredible results when all else had failed, made Lisa realise that she had to get a whole plant cannabis oil for Cole. 

“We nearly lost him”

In December 2018, after putting pressure on First Minister, Nicola Sturgeon, Lisa was told Cole’s name had been ‘picked out of a hat’ and he was to be given one of only five prescriptions in Scotland for Epidyolex. 

But Lisa knew he needed the benefits of a whole plant oil, she says: “I didn’t want to move Cole from a whole plant to isolate, but his consultant urged me to try it. He said ‘it’s free, what’s the worst that could happen?’ And I trusted him.”

Lisa weaned Cole off his over-the-counter CBD oil in preparation for switching to Epidyolex. But on the way to hospital to receive his first dose, Cole collapsed. The Todd’s Paralysis was back, and while being treated with Epidyolex, his condition got worse and worse.

“He wasn’t recovering from Todd’s Paralysis, he started having up to 20 seizures a day which is the most he’s ever had and breakthrough seizures during the day. I had to stay off work. He lost the ability to walk, speak and eat,” Lisa says.

In March Cole was rushed into hospital unresponsive.

“We nearly lost him,” says Lisa.

After extensive blood tests, a lumbar puncture, MRI, CT scan and urine tests that came back clear, the doctors told Lisa: “He just has epilepsy, this is just the way it’s going to be. If you continue with this nonsense, this internet propaganda about cannabis medicines, Cole will die. You need to get him in for surgery, now.”

Scottish debate secured on behalf of 9-year-old seizure-free thanks to cannabis

Cole even attends Taekwondo lessons

Finding success with cannabis

Fortunately, just before Cole was rushed into hospital, Lisa had travelled to Holland to access the whole plant cannabis oil, Bedrolite. Then, as so many other parents have been forced to do, she smuggled the oil back to the UK. 

“I brought the Bedrolite into the hospital and told the doctors I was going to give him his cannabis oil,” she says.

“They assumed I meant the legal CBD oil from before, so they said ‘We’ll turn a blind eye to it but we won’t support it.’ I had to give it to him when no one was in the room.”

Lisa gave him his first dose and that night the seizures halved. The following night they halved again. 

Eventually, Lisa found the perfect balance of Bedrolite, combined with another unlicensed drug, funded by the NHS, Dilantin. 

Apart from some breakthrough seizures when his Bedrolite dose was briefly reduced and when Dilantin became unavailable, Cole has remained seizure free since.

Now, he goes to school, rides a bike and even attends Taekwondo lessons. 

But it’s an immense struggle, both emotionally and financially, to raise £1,300 a month for the privilege. 

Lisa and Cole undertake regular fundraising activities, most recently braving a fire walk which raised enough money to keep Cole safe for another six months. 

But beyond that point, until he can access this life-saving medication on the NHS, Cole’s future remains uncertain.

Lisa says she has even written to the Scottish Government, pleading with them to help fund Cole’s medicine until cannabis is more widely available on the NHS. But she was told it was “a misuse of NHS funds” to pay for his private prescription. 

The NHS and the National Institute for Health Research (NIHR) are said to be working on two RCTs to compare the effects of medicines containing isolated CBD, and isolated CBD with THC, and a placebo.

But while trials are welcomed by campaigners, they will not be suitable for children like Cole, who rely on whole plant cannabis.

Lisa wants the Government to consider observational trials alongside RCTs, as well as making funding available for families facing these crippling costs now.

She says: “I am grateful to have Collette onboard, and to her for submitting this motion. This is another first for us and I hope this will highlight our fight again within the Scottish Parliament and show just how broken the current system is.

“I want to be clear though, that clinical trials are of no use to Cole and will not help him or other children currently taking this medicine, as no parent whose child is safe on a medicine, would ever consider taking them off it, risking their life to give data.

“If the Scottish Government is serious about fixing this they would look at observational trials plus clinical trials and put their money where their mouth is and have funding made available immediately.

Lisa adds: “I fear with the government and NHS only focusing on trials, children such as my son who have paved the way for this medicine will be left behind and forgotten. There must be a long term solution for our children too.”
 
Ms Stevenson added: “I’m keen to hold a members’ debate and highlight the various issues Lisa and Cole have faced. Funding for this treatment is incredibly expensive and that of course leaves Lisa and Cole in a difficult situation as they try and raise funds.

“The current Home Office rules only allow certain doctors to prescribe cannabis-based medicinal products but I understand there is a hesitancy for unlicensed products given the lack of clinical trials. I want to see these trials go ahead – supported by the manufacturers, academics and government, so that NHS consultants can have the confidence to consider prescribing this type of treatment.

“Additionally, I’m keen to discuss the calls for a rule change to allow GPs to be able to prescribe unlicensed cannabis-based medicinal products where a non-NHS consultant has initiated that course of treatment. I pledged to do all I could to help Lisa and her family and I am keen to see the necessary changes which would have this resolved once and for all.”

You can donate to Cole’s campaign here 

 

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Experts publish advice on prescribing medical cannabis for epilepsy

UK experts have welcomed the guidance as a “step in the right direction”

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Experts publish advice on prescribing medical cannabis for epilepsy
New guidance has been published for doctors interested in prescribing cannabinoids.

Estimated reading time: 3 minutes

Experts based in Australia, have published new advice for doctors prescribing medical cannabis to patients with epilepsy.

A group of paediatric and adult epilepsy specialists, clinical pharmacists, pharmacologists, and cannabis researchers from across Australia, have published new guidance for doctors interested in prescribing cannabinoids.

While there is considerable interest in using cannabis-based medications to help treat drug resistant epilepsy, to date, clinicians have little guidance on how or when to prescribe these products.

The new advice published in the British Journal of Clinical Pharmacology, aims to provide some initial guidance for doctors on prescribing in the absence of robust clinical evidence.

The document provides an overview of the different cannabis medicines currently available for treating epilepsy in children and adults, with information on dose, drug interactions, toxicity, and type and frequency of symptom and seizure relief. 

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UK insight

UK experts have urged paediatric consultants and members of the British Paediatric Neurology Association (BPNA) to read the guidance, following updated recommendations from the BPNA published in October.

It continues to advise against the prescribing of unlicensed cannabis medicines in children with epilepsy.

The Medical Cannabis Clinicians Society (MCCS) has since published a response claiming the BPNA stance is “unethical” and fails to recognise the “downsides of not prescribing”, which could include a poorer quality of life, brain damage and even death for patients experience severe recurrent seizures. 

Chair of the MCCS Professor Mike Barnes, welcomed the guidance from Australia, which while “still cautious”, is a “step in the right direction”. 

Matt Hughes, co-founder of Medcan Support, an organisation which supports families living with epilepsy in the UK, also recognised that it was “more open” to the prescribing of unlicensed cannabis medicines that what has been published previously.

The consensus advice will be updated as new evidence emerges and will provide the structure for a more definitive guideline in the future.

Senior author Jennifer H. Martin, MBChB, MA, PhD, FRACP, a researcher at the University of Newcastle and director of the Australian Centre for Cannabis Clinical and Research Excellence, commented:  “In the absence of a registration dossier, scientific experiments and case reports are helpful to provide some guidance to optimised dosing. 

“However, as in this guidance, observational data obtained from clinical practice—which often includes information not included in scientific experiments or even early clinical trial data, such as treating patients with other co-morbidities, taking multiple medications, and patient diversity—can be very helpful to clinical practice.”

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