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Epilepsy

Medical cannabis has ‘96% chance of seizure reduction’ in childhood epilepsy

Medical cannabis has a 96 percent chance of significantly reducing seizures in children with severe epilepsy

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Researchers carried out an audit of real world evidence on 21 patients with a range of severe childhood epilepsies. 

New research predicts that medical cannabis has a 96 percent chance of significantly reducing seizures in children with severe epilepsy.

The clinical analysis, conducted by Drug Science, leading scientific body on drugs in the UK,  examined the use of medical cannabis in under-18s living with a range of refractory epilepsies. 

According to Professor David Nutt, Drug Science founder and investigator on the study, the findings show that cannabis-based medicines are not only safe but a child has a ‘96 percent chance of having a significant reduction in seizures were they to be prescribed.”

The best clinical outcome of typically prescribed NHS medications, such as benzodiazepines or Epidiolex, is “less than 50 percent”, says Prof Nutt.

Researchers carried out an audit of real world evidence on 21 patients with a range of severe childhood epilepsies. 

From the patients enrolled in the study there was an 84 percent reduction in seizure frequency across the cohort with ‘no significant adverse events’. 

Patients also demonstrated a reduction in the use of anti-epileptic drugs after beginning treatment. 

Bayesian analysis of the tendency for medical cannabis to reduce seizures in this group of patients shows that the probability of the next patient showing improvement is 0.954.  

This translates as around a 96 percent chance of having a significant reduction in seizures, as well as a ‘significant  reduction in other health problems. 

These findings were sent to Health Secretary Matt Hancock last week in the hope that it could end a regulatory standoff that is leaving severely epileptic children without access to these treatments.

Epidiolex, which contains pure CBD, is currently available on the NHS for two rare forms of childhood epilepsy in the UK. 

But current regulations prevent the use of whole plant extract cannabidiol due to the absence of randomised control trials  (RCTs) having proved it as effective and safe.  

ProfNutt states that conducting medical cannabis RCTs on children with epilepsy “faces enormous obstacles”.

These studies would require half of participants to stop their current treatment, which would be “wildly unethical, dangerous and could even prove fatal”, he says. 

Despite real world evidence showing highly significant improvements for children being treated with medicinal cannabis, it is not currently accepted as evidence by NICE (National Institute of Health and Care Excellence) or  NHS England.

“Medical cannabis for severe childhood epilepsy is effectively blocked under current NHS rules, despite  convincing clinical evidence on its safety and efficacy,” adds Prof Nutt.  

“An insistence on RCTs means we will never be able to help these children.

“Decision makers within the NHS, the British Paediatric Neurology Association and other clinical bodies need to change tack – and accept real world clinical analysis such as ours.”

Matt Hughes is the father of three-year-old Charlie, who was first diagnosed with a form of epilepsy known as West syndrome in 2018, when he was less than a year old.  

“Charlie would have upwards of 100 seizures every day. He wouldn’t be able to function or have a normal life,” says Hughes.

“The standard medications that were prescribed on the NHS did very little to help, and came with some pretty dreadful side-effects. Four of the anti-epileptic  treatments that Charlie was prescribed were unlicensed for his condition.

“The treatment that has helped Charlie in the most lasting and effective way is a private prescription of medicinal  cannabis.” 

Charlie is now given a cannabis-medication called Celixir20, which he takes as three liquid doses (each of 0.4ml)  each day. The medicine is privately sourced from a company in Israel, where it is approved and licensed for use on childhood refractory epilepsy.

Hughes continues: “He now has fewer than 20 seizures a day and those are far less severe. He sleeps well, eats well and the improvement in his health is self-evident. 

“Yet this medicine is still not considered to be clinically effective  by UK legislators, simply because it hasn’t been studied with an RCT. In fact, our clinician has told me that he would  never recommend Charlie take part in such a study, for fear it would jeopardise his newfound stability.” 

Hughes setup Medcan Support last year to help other parents to access and cover the high costs of private prescriptions.

“I have wiped out my own savings looking after Charlie and my story is far from unique,” he adds.

“I regularly hear from people  who have been forced to sell their house, just to help their child, or who are doing everything they can to raise funds. It’s a stressful and precarious position for parents, wondering if we’ll be able to afford the medicines that our children need.

“What is absolutely clear to us is that these medicines work. Scientists around the world agree, and the amount of  real-world evidence on the effectiveness of medical cannabis is growing.”

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Epilepsy

“An important milestone” – Father’s joy as son receives first MCAP prescription

Brendan Gorman said the prescription was ‘great news’ and hopes it will mean more benefits for others.

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Ryan Gorman, a 26-year-old man, from Dublin, has become the first patient to receive the cannabis-based product, CannEpil, through Ireland’s Medical Cannabis Access Programme (MCAP).

The MCAP was introduced four years ago, although this marks the first product to be prescribed under the scheme. It was only announced in 2021, that Cannepil would be the first product available. CannEpil is a high CBD, low THC formula developed by MGC Pharmaceuticals.

Speaking with Cannabis Health, Ryan’s father, Brendan said: “Hopefully, this will progress to a place where his seizures are reduced and his life is of better quality.”

Seizure: a portrait of Ryan Gorman

Ryan Gorman is the first patient to receive medical cannabis through the scheme

There are currently around 37,000 patients with epilepsy in Ireland. Of this number, Brendan estimates that 800 patients would have the same type of epilepsy that Ryan has, making them candidates for the MCAP.

Ryan developed seizures when he was just 15 months old. He is now in his mid-20s and currently experiences clonic tonic and absent seizures twice a day.

“He developed febrile seizures when he was 15 months old. These were very serious life-threatening seizures,” Brendan said.

“In the beginning, they offered him standard anti-seizure, epilepsy drugs. They kept him alive, as he is still here but they weren’t getting the seizures to a good place. They weren’t controlling them to any extent,”

“His seizures were very prolonged and very physical. It’s very concerning because you can die from a standard seizure.”

Brendan highlighted that there are constant risks to Ryan’s safety as a result of his epilepsy.

Ryan’s height means that his clonic tonic seizures can be difficult for carers to manage physically. Brendan has been waiting on surgery for five years for a hernia he sustained from dealing with Ryan’s seizures. He has delayed surgery twice while waiting for news on Ryan’s medical cannabis access.

Brendan explained: “There are two types of seizures that Ryan has; one is referred to as absence seizure which would last about 15 to 20 seconds and this will go on throughout the day periodically. There would be a risk in terms of where you are, if you were on an escalator then he could simply fall, or if he was climbing the stairs at home.

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“The second type of seizures, the clonic tonic ones are incredibly physical, but also more life-threatening and dangerous. They can go on for 12 to 16 minutes and he is six foot four. He is a grown man who will be 27 in December so over the years they have become more pronounced because of this.”

Seizure control

As the seizures became more difficult and showed no signs of being controlled by medication, Brendan became curious about what medical cannabis could potentially offer Ryan. He had no prior interest in cannabis but he was desperate to access any alternative treatment that may work.

“If you have a child, son, sister or brother that is suffering intolerably from a dysfunctional medical ailment, what else can you do? If this is a treatment that doesn’t have a negative impact on the person who takes it, then that was the only option for us, once it was legalised. It’s only natural to follow through with it.”

He added: “We won’t know yet if it’s going to be a success story, but the information on the ground is that it has worked for a number of people in many different countries. When it comes to medical cannabis usage, Ireland is behind from that point of view in terms of the Netherlands, Belgium or even the South American countries.”

Brendan is incredibly hopeful that the medication will have a positive effect on Ryan. It was only granted on Friday 19 November, so Ryan has yet to start taking CannEpil.

“All we can do is hope that what has been prescribed will have the desired effect. I put it to Ryan’s consultant neurologist in St James Hospital in Dublin and he was behind the idea from when we first talked about it over two years ago. He said Ryan would be a candidate if it was made legal but his only concern was the level of THC contained in it.”

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Ryan’s consultant is Dr Colin Doherty from St. James Hospital. He has become the first doctor to prescribe through the programme. He was one of many neurologists who stated their concerns about it, due to the levels of THC contained in the products suggested for a prescription. CannEpil is a high CBD, low THC product and is so far the only one available through the MCAP.

The HSE has confirmed that three patients, who are all believed to be adults, have been added to the MCAP in recent weeks.

There has been widespread criticism of the programme that it does not include enough conditions, in particular, chronic pain. It currently only allows for the prescribing of cannabis for nausea induced by chemotherapy, multiple sclerosis and epilepsy. There have been a number of attempts to get more products available but so far, only CannEpil has been successful.

 

CannEpil and seizures

Brendan will be monitoring Ryan closely when he starts on CannEpil. He is positive about the prescription but remains cautiously optimistic about the benefits.

He said: “I’m going to be administering this myself on an incremental basis in small doses. I’ll be monitoring him to see how it affects him and if it’s beneficial or not. It contains a small percentage of THC which has been known to counter the seizure profile and reduce it. It may be at a higher level than the neurologist would have desired, which I’m in agreement with, but we are in a place where there is no other option. This illness he has is a life-threatening one so it’s something a parent has to make with some degree of difficulty as you ask yourself, what other options have you got?”

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Brendan continued: “In terms of how it’s going to benefit Ryan and others out there, it’s wonderful news. You don’t want to get yourself into a state of believing this is a silver bullet but you want to remain hopeful. You need to apply logic as well as emotion. Everyone has a degree of euphoria when they get some really good news, but then the dust settles. This hasn’t settled yet, as it’s very transitional right now. I’m very happy after all these years as it’s down to the hard work of people protesting, including myself.”

Protesting and access

Brendan is grateful to Gino Kenny, the People Before Profit TD who has fought to make medical cannabis more accessible for patients, saying: “He is a lovely man who spearheaded the whole idea of making medical cannabis accessible. It’s been a long road, over five years now, since he put it before our government.

He also acknowledges the role of cannabis activist, Vera Twomey.

“Vera showed real spirit to walk all the way up to Dublin,” he added.

“When you have a child, then that is the driving factor. You could be an ordinary individual but if something like this arrives at your doorstep then you have to get the strength from somewhere to become proactive. If Ryan benefits, and it follows that there are benefits for others, then that’s brilliant.”

Speaking with Cannabis Health, Kenny commented: “This is an important milestone in regards to families and campaigners who have been highlighting this issue for the past five years. Many of us remain very critical of the MCAP and its limitations. The first person getting access via prescription hopefully represents others that need the legal and medical access to this treatment.”

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Epilepsy

Dublin man becomes first patient to receive prescription through MCAP

Ryan Gorman, from Dublin has become the first patient to receive CannEpil through the Medical Cannabis Access Programme

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MCAP: A photograph of the Ha' Penny bridge in Dublin

A 26-year-old man from Dublin has become the first patient to receive the cannabis-based product, CannEpil, through Ireland’s Medical Cannabis Access Programme (MCAP).

Ryan Gorman, from Clondalkin in Dublin, suffers from intractable epilepsy which is resistant to current drug treatments.

Dr Colin Doherty from St. James Hospital, a consultant neurologist became the first doctor to prescribe through the programme. He had originally expressed doubts about the programme, describing it as a ‘farce‘ that there were no suitable products available.

MCAP: A banner advert for Always Pure Organics

MCAP was introduced four years ago although this marks the first product to be prescribed under the scheme. Despite being introduced in 2019, it was only announced this year that Cannepil would be the first product available. CannEpil is a high CBD, low THC formula developed by MGC Pharmaceuticals.

There is still widespread criticism of the programme and its failure to include more conditions, in particular, chronic pain. It currently only includes nausea induced by chemotherapy, multiple sclerosis and epilepsy. Patients must have tried every alternative medication available before they are allowed to be prescribed cannabis-based products.

There have been few updates to the programme since its launch although it was added to the primary care reimbursement scheme in 2021 meaning that products are now free.

MCAP products

In a statement to Cannabis Health, the HSE stated: “The HSE has registered three patients under the MCAP in recent days. We would not be aware whether the consultant neurologist has proceeded with prescribing for an individual until claims were submitted from pharmacies at the end of the month.”

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Speaking with Cannabis Health News, Gino Kenny said: “This is an important milestone in regards to families and campaigners who have been highlighting this issue for the past five years. Many of us remain very critical of the MCAP and its limitations. The first person getting access via prescription hopefully represents others that need the legal and medical access to this treatment.”

MCAP access

Speaking with Cannabis Health News, Natalie O’ Regan, a drug policy specialist said: “I am delighted to see the MCAP finally up and running and a patient get their first prescription. The road to this moment has been a long and difficult road in Ireland. This process of MCAP started in 2017, almost five years later and the first patient is finally able to benefit from the programme. Although the scheme itself is severely restrictive and needed reform before it ever left a desk, it can still make a tremendous difference.”

She added: “I have commented in the past that the MCAP is unfit for purpose, and I stand by that statement, regardless of the right or wrongs of the programme, someone has benefited from it, someone will have a better quality of life now they can access cannabis-based medication. Ryan Gorman is now the first patient to receive medication under MCAP.”

“Ryan is one of many thousands in Ireland that suffers from epilepsy and one of many whose epilepsy is treatment-resistant. With Ryan being the first I hope many others will follow suit and we can see first-hand the difference it can make to people. I hope accessing this medication will make a huge difference to Ryan’s quality of life and I wish him every success.”

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MCAP failures

Earlier this month, Gino Kenny raised the issue of the lack of prescriptions in the Dáil to Taoiseach, Michael Martin. Mr Kenny has been a key campaigner in the fight to improve access to medical cannabis in Ireland.

“Many families would have been very joyous during the summer when the medical cannabis access programme was to commence. But sadly, in a PQ response today, not one patient has been given access thus far. That is a huge disappointment to those families that this treatment could make life-changing benefits,” he said.

“So what do you say to families that feel let down by the programme and now they have to look at other treatments and probably getting no treatment at all?”

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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.”

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