Two Years of Research
Drug Science research, conducted over the past two years and in close collaboration with the affected families, clearly shows the immense benefits of medical cannabis treatment for these patients.
In contrast to the current BPNA guidance stating that prescribing medical cannabis is probably not in the best interests of children, our studies clearly and consistently show that for these children, medical cannabis treatment is indeed in their best interests.
We are grateful to all the families who took the time to be interviewed and who openly and honestly shared their painful, personal stories. We did not believe that we would come to the end of our research with families still being in the same intolerable situation. We hope the current publications do your experiences justice.
Ending the Pain of Children with Severe Epilepsy? An Audit of the Impact of Medical Cannabis in 10 Patients.
Zafar R, Schlag A, Nutt D. Drug Science, Policy and Law. January 2020.
This study assessed the impact of whole-plant medical cannabis oils including THC and CBD in 10 children with a diagnoses of severe treatment resistant epilepsy.
All children had previously failed on anti-epileptic drugs and other supportive therapies including vagal nerve stimulation, ketogenic diet and the licensed CBMP Epidiolex. All children in our study managed to show an improvement in monthly seizure frequency when using whole-plant medical cannabis. Seizures fell by 80% across the group of children after starting treatment, with two children achieving complete seizure freedom.
The use of anti-epileptic drugs, known to have deleterious effects on development and cognition, were reduced from an average of 8 AEDs to 1 AED per patient following treatment with medical cannabis.
We found that parents were paying around £1800 per month to obtain these private prescriptions from specialists’ clinics due to the refusal of the NHS and the CCGs to pay for them. The refusal by the NHS and CCGs to prescribe is based on pressure from the BPNA and NICE who refuse to acknowledge the positive clinical impact these drugs are having in completely reversing their conditions, despite us finding such clinically impactful results.
Monthly Seizure Frequency Pre & Post Initiation Of Cannabis Based Medicinal Products
Medical Cannabis and Epilepsy in the UK – A Qualitative Analysis of the Carers’ Perspective:
“We’re Asking for Quality of Life for our Children”
Schlag A, Zafar R and Nutt D. Drug Science, Policy and Law. January 2021.
Following on from our quantitative study highlighting the effectiveness of CBMPs to treat severe intractable childhood-onset epilepsy, for the present study, we used a narrative, open-ended approach to interview 11 parents/carers of these patients. We aimed to understand the families’ situation in more depth, and to contextualise our previous findings.
It was heart-breaking to see that, although these families have found CBMPs to be the most effective treatment for their child’s condition, unfortunately access to these medicines remains severely restricted, causing serious challenges in their day-to-day life.
Looking at the wider picture, parents/carers highlighted the broad range of issues they experienced in relation to medical cannabis – these included the challenging regulation and policy surrounding medical cannabis, their anger and sheer desperation related to these policies, as well as the broad variety of benefits experienced as a result of using the medicine.
Evidently, the benefits of medical cannabis for these children far outweigh any associated risks (please see Fig 1). All families agreed that CBMPs allow their children a substantially better quality of life than is possible on other AEDs alone.
Many of the issues raised in our study are not about the science of medical cannabis per se. Rather, they are political issues, related to the wider issue of trust and power in society, and the importance of expert versus lay opinions. This has wider implications than medical cannabis alone.
The way that families are treated contrasts markedly with the way they would like to be treated and emphasises the importance of including patients in decision-making about their medical plans and the value that should be given to their reported outcomes and wishes. A holistic model of care – with more focus on compassionate and ethical treatment of patients and their families – is essential. Access to CBMPs is one important aspect of this, together with more professional support, better communication with clinicians and policy makers who need to do more than pay lip service.
Perceived benefits vs risks of medical cannabis
Drug Science Recommendations for Medical Cannabis in Relation to Children with Treatment-Resistant Epilepsy
Most of the families in our studies still require affordable and sustainable access to their CBMPs. It remains a matter of urgency to improve access to medical cannabis for these children.
We outline the following recommendations to improve patient access – some of these are specific to paediatric epilepsy but most carry general relevance.
Mandate the NHS to fully fund the treatment costs for current patients once their consultant has agreed that there is adequate clinical benefit
As the UK is now left with only one prescribing neurologist privately, further physicians need to be educated and trained urgently (e.g., through Medical Cannabis Clinician’s Society)
Remove the need for BPNA involvement in these
Provide training for other specialists and GPs who would like to learn how to prescribe
Support and encourage GPs to take shared care for these children and so be allowed to continue prescribing under the specialist supervision
Collect nationwide data on these and other similar children using a data base such as for the Drug Science’s Project Twenty21 initiative
Use this data base to evaluate effectiveness of medical cannabis in these children using real world data
General Drug Science Recommendations for Medical Cannabis
Involve patients in their care and listen to parents/carers
Make a wider range of CBMPs available on the NHS - especially for patients who have been shown to benefit f rom the medicine
Reduce stigma towards and ignorance of medical cannabis by supporting education for doctors and healthcare professionals
Widen the NICE evidence base to include real world data to complement RCTs
Conduct a full health economics analysis of the value of medical cannabis in some syndromes where clinical trials are unlikely to be conducted e.g., Ehlers Danlos syndrome
Build up the current evidence base by providing research funding
Establish an Office of Medical Cannabis (as e.g., in the Netherlands) to address issues efficiently
Reschedule d9THC to Schedule 2 to facilitate research