Alfie celebrates two years seizure freedom – Mum Hannah calls for change.
Alfie Dingley suffers PCDH19 which is a genetic mutation and the cause to his severe treatment resistant epilepsy. In 2018 mum Hannah was center of a high profile campaign which led to a license being granted to allow Alfie to receive prescription cannabis and a few months later in November saw the change in law to allow prescribing of cannabis for the population of patients who needed it.
Thursday 28th April 2022, Hannah, Drew, Annie and Maggie celebrated two years seizure freedom. This freedom has allowed Alfie to thrive and live the best life, and has had a big impact on the quality of life for the family with Hannah now able to start a new career and work full time.
In 6 months we will be marking four years since that change in law, and to date there have only been three NHS funded prescriptions of full extract cannabis oils.
Hannah has called upon the BPNA and leading neurologists to meet with her to discuss the current blockages to access within the private the sector. The UK currently has one paediatric neurologist prescribing cannabis based medicines for children with severe treatment resistant epilepsy. Despite the great efforts of the Medical Cannabis clinicians society to recruit new paediatric prescribers, there is a great reluctance to come forward. Since the retirement of Dr Martinez of Portland Street Hospital, Dr Beri of Sapphire clinics is unable to refer his patients in the event anything were to happen to him. It was the responsible thing to do and close access and stop taking on any further patients.
This has left a large population of families with no access to prescription cannabis under clinical guidance, forcing them to the over the counter CBD market of illicit sources.
BPNA have always called for further robust evidence in the form of randomised controlled trials, but in October 2021 BPNA reviewed guidance after calls for them to bring them in line with the NICE clarification to prescribing, sadly their stance was a zero tolerance approach impacting access within the private sector with guidance stating ;
“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.
“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. “
In her letter to the BPNA requesting a meeting, Hannah has explained the huge benefit to Alfie’s health and quality of life. Prescription cannabis has resulted in huge savings to the NHS, as a result of Alfie needing fewer conventional anti-epileptic drugs (AEDs) and practically no need for hospital visits.
Hannah says:
Today [Thursday] marks two years seizure free for my son Alfie Dingley. His NHS prescription has given him two years of attending school, of making new friends and of healing from the years of seizures and devastation which hit him for many years before. It has also meant a chance for our family to heal.
It is a moral and ethical outrage that so many other families are denied NHS access to this medicine and are being forced to go private at huge cost.
On this two year anniversary of my son being seizure free as a result of this life transforming medicine I am challenging the leading doctors concerned, and the relevant regulators, to accept my invitation to discuss this situation. Many of the parents being denied prescriptions, both on the NHS and now privately, believe that guidance from the BPNA is playing a significant part in the blockage, hence my challenge to them.
The law change has led to an embryonic medical cannabis sector in the UK and a few thousand adult patients now benefit from this medicine for a range of conditions due to the emergence of a number of private clinics. However, it seems that even these private clinics are reluctant to prescribe to children with epilepsy.
It appears that the BPNA and other leading medical figures and regulators are concerned about whether there is enough evidence that medical cannabis is safe and effective, but there is a vast amount of real-world evidence and observational trial data available from all other the world.
As regards safety, if it isn‘t safe why was the law changed in the first place? Cases like Alfie’s show just how effective this medicine can be. It is the duty of all responsible to work together on a solution and not ignore the suffering of the many families who are currently keeping their children alive by paying for private access
Dr Evan Lewis of Neurology Centre Toronto a paediatric neurologist who actively prescribes cannabis for his patients has taken the harm reduction approach. Families are going to source cannabis regardless, surely it’s safer under clinical supervision where the clinician can learn but also monitor the patient rather than leaving desperate parents to go it alone, potentially opening up their child to further risks.
Photo taken by CLC Portraits.
Building the future of cannabis clinical trials using real world evidence.
To sign up
A panel discussion with global experts about integrating real-world evidence into the development of clinical trials on cannabis products.
About this event
This free webinar is hosted by the Canadian Childhood Cannabinoid Clinical Trials (C4T), MedCan Support and Drug Science. Questions can be submitted beforehand to C4T.Canada@gmail.com or through twitter #C4TMedCanDrugScience22. This 90-minute panel discussion will include expert speakers including researchers, clinicians, and parents from Canada and Europe.
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Expert Speakers:
Matt Hughes is the Co-Founder and Director of MedCan Support, a hub for education, advocacy, research and support in the use of prescribed cannabis in paediatrics. Matt has been involved in the UK Medical Cannabis sector since early 2019 when his son Charlie was prescribed cannabis in the treatment of his severe treatment resistant epilepsy. Charlie has seen a dramatic reduction in seizures and much improved quality of life. Matt continues to campaign and advocate for population wide NHS access for children suffering with severe epilepsy and be a voice for patients and families within the growing private cannabis sector joining the executive committee of the UK Cannabis Industry Council.
Dr. Callie Seaman is a Plant Scientist and Formulation Chemist with over 20 years of experience in the hydroponic industry. She has worked with a number of licensed cannabis producers within the UK and internationally as a director and researcher helping to optimize and set up research programs around secondary metabolite production within cannabis. She first completed a degree in biomedical sciences, during which she worked for GlaxoSmithKline within the drug metabolism and pharmacokinetics department. She then went on to complete a PhD in fertilizer chemistry at Sheffield Hallam University whilst setting up a liquid fertilizer manufacturing company, formulating and taking to market a full range of products. As a patient she is passionate about educating everyone about cannabis and helping to support patients through their journey with cannabis prescription, through volunteering for organization such as MedCan Support and PLEA (Patient-Led Engagement for Access).
Dr. Anne Katrin Schlag is a Chartered Psychologist and Head of Research at Drug Science. She leads the research for the Drug Science Medical Cannabis Working Group, focusing on controversies surrounding medical cannabis, the improvement of patient access, and the continued development of education and stakeholder communication about medical cannabis. Dr. Schlag is currently working on progressing the scientific evidence base of medical cannabis to include Patient Reported Outcomes, observational studies (such as T21) and the application of Multi-Criteria Decision Analysis to assess the benefits and safety of medical cannabis. She holds Honorary Fellowships at both Imperial College London and King’s College London, chairs the research subgroup of the Cannabis Industry Council, and is scientific advisor to the Primary Care Cannabis Network.
Dr. Bruce Crooks is an Associate Professor of pediatric hematologist/oncologist at IWK Health and Dalhousie University in Halifax, Nova Scotia. Originally from, and trained in the UK, he has been in Halifax since 2002, caring predominantly for children with cancer, particularly CNS tumours, patients requiring bone marrow transplant, retinoblastoma, and solid tumours. His interest in medical cannabis grew from the interest families had in using it for supportive and curative care, despite the paucity of medical information available. He is interested in helping to determine the place of medical cannabis in the treatment of children, not only with cancers but also with other medical conditions, and facilitating frank and open dialogue between families and healthcare professionals about medical cannabis.
Alexander Repetski is a Media Production Artist and Communications Strategist. His interest in medical cannabis became increasingly important in 2012 when his daughter Gwenevere was diagnosed with intractable epilepsy. He came across cannabis while researching various areas of neuroscience in an effort to understand treatment options. After repeated failures of traditional therapies, he has successfully managed Gwenevere’s seizures with specialized cannabis cultivars, extractions and formulations. He is regularly asked to speak about his experiences to audiences both within the cannabis patient community and the academic world. He has worked in the cannabis industry with data start-ups and LP’s for the past 7 years. Alexander is now focused on assisting research of all forms to advance the evidence-based understanding of cannabis treatment. He enjoys fresh ideas and hugs from his children.
Moderator:
Dr. Lauren Kelly is a Pharmacologist, Assistant Professor in the Department of Pharmacology and Therapeutics, and the Department of Community Health Sciences at the University of Manitoba. She is a Certified Clinical Research Professional and a Systematic Reviewer. Dr. Kelly received her Doctorate in Pharmacology and Toxicology from the University of Western Ontario and completed two post-doctoral fellowships at the Hospital for Sick Children and Mount Sinai Hospital in Toronto. Dr. Kelly is the PI for the Clinical Pharmacology Lab, the Clinical Trials Director and a Scientist at the Children’s Hospital Research Institute of Manitoba, and the Scientific Director of C4T.
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For more information on C4T, MedCan Support or Drug Science please visit the websites below.
C4T: https://www.c4trials.org/
MedCan Support: https://medcansupport.co.uk/
Drug Science: https://drugscience.org.uk/
This event will be broadcast with closed captions on YouTube Live by the University of Manitoba. A recording will be available and sent to everyone who has registered after the webinar.
The Tussle over treatment for severely epileptic children turns ugly – The Economist.
Any parent can relate to that overwhelming sense of protection, you’ll do anything it takes to keep your child safe and well. Sajid Javid said this himself when allowing Alfie Dingley a license to use cannabis in treating his seizures, it was exactly this reason why Hannah Deacon and partner Drew fought so hard.
Last week at the recording of the GCI summit, Hannah hit the nail on the head highlighting STIGMA associated with cannabis, clinicians have grown up with cannabis being a banned, harmful substance with no medical value. Then came Alfie Dingley and Billy Caldwell whose lives were literally saved by this banned substance. Through high media coverage and public pressure, the government changed the law to allow clinicians to prescribe.
But as stated by the Economist – legal doesn’t mean accessible.
The campaigns and change in law are obviously not the conventional way a medication comes to market, NHSE / NICE were asked to produce guidance on a botanical medication they know little about, a medication which has multiple active compounds and multiple methods of action all rolled into one? But crucially a medication they have grown up believing is potentially very harmful.
For this reason to a small degree it’s understandable NICE & BPNA’s need for clinical trials and concerns, but here lies the issue, this unconventional medication doesn’t fit the pharmaceutical gold standard tests (RCTs). Randomised controlled trials were designed to test single molecule pharmaceutical medications, it was never intended to test botanicals?
NICE dismissed 4000 real world studies in cannabis and childhood epilepsy, some simply because they were in a foreign language and could be misinterpreted. Acknowledgement of the experience and expertise of international clinicians and researchers has also mostly been dismissed which has led to extremely restrictive guidance until the gold standard tests have been carried out. There is no excuse for ignoring the overwhelming evidence base, as highlighted by Drug Science and the Canadian Childhood Cannabinoid clinical trials, RCT’s cannot answer all the questions, real world evidence can work in conjunction with and complement current RCT. We have enough data to know cannabis under prescription is safe and effective.
“Alasdair Parker, a consultant pediatric neurologist at Addenbrooke’s Hospital in Cambridge, is the bpna’s president. In animal trials, he warns, small quantities of thc have made seizures worse, not better. thc has been associated with psychological problems in teenagers, and some fear long-term effects on developing brains.
But for desperate parents, such caution cuts little ice. Worries about long-term effects feel by-the-by when weighed against a very poor quality of life and the risk of death, says Hannah Deacon”
Families and clinicians have to weigh up side effects, seizure control and quality of life of every drug prescribed, do the benefits outweigh the risks? Many commonly prescribed anti-epileptics can have serious side effects or be extremely addictive. Many have no RCT’s in children prescribed off label, many used in conjunction with no trials or evidence to suggest it’s safe. Yet through widespread prescribing and experience, through real world evidence, these risks are accepted.
The risk of THC to a child’s brain versus hundreds of seizures is minimal given there is no evidence. Our children are not neuro-typical and many suffer from global development delay or severe autism/behavior, some unable to talk, feed or walk. BPNA guidance doesn’t take this into account.
Recreational smoking of high THC cultivars via the illicit market is a world away from prescribed THC in small doses alongside the other cannabinoids. Dr Dani Gordon speaking at the GCI summit raised the point that the merging of evidence from recreational use into medical has brought about concerns and fears of using THC in young children, but these studies are not comparative to medical uses under clinical guidance.
Dr Parker has said
“ Some pediatric neurologists feel threatened, bullied and harassed”
Although we don’t condone bullying or threatening of clinicians, we can’t help but feel the guidance and complete block of prescribing was only ever going to lead to families frustrations spilling over to anger. We have to remember these families have jumped to every word their neurologists have asked, their children have been prescribed many off label, unlicensed medications, keto diets and even brain surgery. Our children have failed everything thrown at them, once two AEDs have failed, the chance of another helping drops to 3%. It’s a common occurrence to be prescribed medications that have already failed “just in case they now work” – over and over medications which have failed are prescribed to avoid using cannabis. This only adds fuel to the fire when there is a medication which could benefit their child, but families are expected to wait on trials which we have learnt have been pushed back to 2024.
“The health minister, Maria Caulfield, says the problem with access is clinical, not political. Some blame new guidelines from the British Pediatric
Neurology Association (bpna). The organisation does not advise the use of unlicensed cannabis products because it feels there are not enough data on safety and efficacy. It counsels waiting for the results of a trial by the nhs. These would not come before 2024.”
Sadly this argument will continue whilst we have unbalanced guidelines, with the NHS trials beginning in 2024 and no access to prescribed, safe cannabis under clinical guidance we are only going to see further strain between NHS neurologists and families.
We feel the government could help. They have the power to bring NICE, MHRA and DHSC together, work on new and novel solutions to increasing the current evidence base, but accepting botanicals as a medication. It’s been suggested by both Maple Tree and Volteface that a new government office of cannabis oversees licensing, removing the role from the Home Office, these are great ideas to move things forward, but we need government to hear them and begin working with industry and developing pathways and industry standards to fund whole plant medications.
We do need continued research from within the UK, but this in itself brings its own set of challenges fundamentally funding of which is currently only available via private investment. NICE and NIHR have a call for industry to bring forward their products for trials, yet the domestic industry is still very much in its infancy and the appetite to invest CBPMs in children is currently very low. Industry has to play a future role in R&D, with innovation and science at the forefront, which in time will lead to an increase in bioavailability, new methods of administration, all of which will help overcome the attached stigma and allow acceptance. But this will take time, many years and requires high investment.
So here we are three years on and in a catch 22 situation…..those who have the power to allow population prescribing, require robust trials of which the medication is not suitable, families upset and angry campaigning for access with government diverting the issue away from themselves blaming the lack of robust evidence to allow prescribing of which the medication is not suitable….
The merry go round continues……
In the meantime children continue to suffer, families continue to suffer, the divide gets wider.