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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.


Three years, Three prescriptions – the failure of Medical Cannabis.

In the past 30 years the development of new medications for epilepsy has been slow, and as reported by Epilepsy Research UK, only 0.3% of health-related funding is spent on epilepsy research (which works out at £21 per person suffering with the disorder).120,000 children under 18 in the UK suffer with epilepsy and approx 33,000 of them have a severe treatment resistant form of epilepsy which does not respond to primary treatments, leaving them to suffer up to hundreds of seizures per day and at high risk of sudden, unexpected death because of their disorder.

Approx 11 people will die each week due to uncontrolled epilepsy.

Three years have past since the law was changed to allow cannabis to be prescribed by a specialist clinician. Yet access is still severely restricted within the private sector and continued calls that the evidence base is simply not there to support population wide prescribing on the NHS.

The Medical cannabis sector and in particular in the use of treating childhood epilepsy have some significant challenges yet to overcome.

NIHR and NICE highlighted key areas for research with a call for Randomised Controlled Trials (RCTS) in the standardised approach for childhood epilepsy. This is a major stumbling block. RCTs by design had one purpose in testing single active molecule medications. It’s going to be extremely challenging and expensive for licensed producers to conduct these types of trials in a whole plant cannabis product with various active compounds and dependant on duration of trial, small variance between batches. Thus far only isolated compounds have been able to be tested in this way.

Most childhood epilepsy syndromes are rare. RCT trials are extremely expensive, so there is little to no incentive for producers to conduct such a trial in children, given little to no return on investment. This is especially relevant to the UK domestic industry whilst it’s still very much in its infancy and yet to have a GMP product ready to undergo such a trial.

As stated by Drug Science RCTs are not necessarily the best option ;

One reason for this is the relative lack of randomised controlled trials (RCTs) of medical cannabis treatment. While RCTs have long been seen as the gold standard of research, it is important to understand that results from RCTs do not always translate to real-world therapeutic use. This is particularly true with medical cannabis patients, where many suffer from multiple pathologies which would exclude them from an RCT, thus making it difficult to predict their health outcomes from RCT results alone. This is why real-world studies such as Project Twenty21 are so important.

NHSE review into the barriers to accessing CBPMs confirmed NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT.
This scope of study should include those children and young adults who are currently in receipt of a CBPM.”

Yet the British Pediatric Neurology Association states that they don’t support observational studies

All parties involved in the trial design agreed that the study methodology would provide evidence of significant scientific value and that an observational study with a small patient cohort would not produce similarly robust results nor add to the current evidence base, and certainly not provide results suitable for routine clinical or commissioning decisions.This is particularly true for THC-containing products where there is very limited published and peer reviewed evidence of efficacy and safety for this indication.

BPNA and NIHR will be conducting RCT’s, the aim is to test whether THC has any added benefit over just CBD in seizure control. We are told that in early 2022 they hope to see the trials begin with two placebo groups. First group will use CBD and the second will be CBD/THC at a 1:20 ratio. This is much needed research, but doesn’t take into account the known pharmacokinetic interactions between cannabinoids, and the entourage effect. Although science still has much to learn and understand, we do know through real world evidence that whole plant cannabis appears to be more effective than isolated counterparts. Assuming THC in isolation brings increased control, would this evidence be enough to satisfy clinicians concerns to allow prescribing of unlicensed whole plant cannabis?

These RCT’s would not answer the other fear over THC and developing brain, that would require long term observational studies.

Jeff Smith MP Labour MP for Withington, south Manchester also highlighted in Parliament

On the issue of Randomised Controlled Trials he said that over 70 medicines have been licensed in such circumstances and that cannabis, with its 100-plus compounds is a ‘unique plant and, as such, ministers need to be flexible and creative in looking at new ways of breaking the log-jam. We need a new concerted attempt with some with new thinking…rather than seeing people paying a fortune to illegal drug dealers or leaving people condemned to a life of pain,

Evidence is crucial in allowing population wide access, but given the only evidence in whole plant cannabis is being gathered through privately funded studies (Medcan Support / Drug Science and Sapphire clinics), of which will remain small due to the UK only having one neurologist prescribing – serious questions need to be asked of Government and the Dept of Health in providing research funding but critically how these challenges can be overcome. As an industry how we can push forward access to these medications which time and time again have proven to help and transform lives.

In the meantime, many thousands of children are left suffering with no option but to seek advice and product from illicit sources with no clinical oversight.

Stop Denying Patients Access to Medical Cannabis on the NHS – Petition

Lets get to one million! – Medical Cannabis access on the NHS

In 2020 I co-founded MedCan Support with my friends Matt Hughes who has a son, Charlie with epilepsy and also Dr Callie Seaman who is a plant scientist and also has epilepsy. Through our shared experiences of using prescribed cannabis for our children and the challenges we faced, and knowledge we built, we felt there was a huge gap in supporting families. Medcan support is a non-profit organisation and a central hub for education, research, advocacy and support to the many families who are struggling with chronically unwell children who wish to pursue using medical cannabis with their child. We all felt very alone when we were researching the  use of medical cannabis and we don’t want anyone to suffer as we have in the past.

Although our aim is population wide NHS access for prescribed cannabis to all children suffering severe epilepsy, we wanted to help in other ways also. Before Alfie was well, I was so afraid and worried for his future and struggling to cope, I reached a point I felt I couldn’t go on anymore. There are so many families going through what I did. It’s sadly all too common to see parents and siblings suffering anxiety, depression and PTSD. With little to no respite and no support from NHS and families left to cope we want to raise funds to support families with receiving mental health support, respite, holidays and any specialist equipment needed.

We are hugely grateful that Melanie Sykes has recently agreed to become our Ambassador and help us raise awareness of medical cannabis access issues in the UK will also help support us with above in raising funds for our families.

We are also calling for more signatures for my petition. Lets get it to 1 million signers, then I can present it to the Prime Minister and ask him to urgently intervene in this policy failure that we see around medical cannabis access.

Please watch our film and share the link to our funding page and the petition both here to help us make sure that access is available on the NHS.

Best wishes

Hannah, Matt, Callie and Melanie xx

Melanie Sykes joins Medcan Support as Ambassador

We are excited to announce that Melanie Sykes has joined Medcan Support as Ambassador, her support will help us to raise the issues which are preventing access to medical cannabis within the UK.

Despite the law change in 2018, only three NHS prescriptions for whole plant medical cannabis products exist, access is only available via the private sector at large costs per month. This leaves vulnerable families struggling to raise funds to pay for private prescriptions and have that extra responsibility added to an already stressful situation. Those unable to afford prescriptions are left with no choice
but to turn to the unregulated illegal market and risk the inherent dangers of this choice.

With the added burden of funding private prescriptions, we aim to support families financially with grants for mental health support, respite, holidays and specialist equipment.  The impact of learning your child has a very severe illness, one that has no cure and many suffering severe disabilities and developmental delay, knowing life will be completely different to what you imagined, can cause severe anxiety, depression, PTSD, and these symptoms can be very common among parents.

Today we are also launching our fundraiser, we need your support to help families and bring some much needed relief by donating below ;

We look forward to working with Melanie and raising this issue with more information to follow soon…..

“I’m hugely proud to announce that I will be supporting MedCan Support as their ambassador.
I have been moved by stories of parents who face constant fear and worry from caring for
a child with severe treatment resistant epilepsy and for me this is unimaginable, the
welfare of the whole family unit is paramount, the child’s needs, the parents mental
health, as well as brothers and sisters who are greatly affected by having a sibling with

I was made aware of the struggle these families are facing in accessing medical cannabis
on prescription, this medicine has shown to reduce seizures and improve wellbeing for the
whole family. Sadly, families are left paying large sums of money via the private sector to
access this life changing medicine. This causes further worry and anxiety to an already
stressful environment. Adults too are suffering from a range of morbidities and
comorbidities and they have seen tremendous benefit from using medical cannabis,
but at large costs.  The law was changed in November 2018 to allow medical cannabis
to be prescribed, yet
only three NHS prescriptions for whole plant cannabis exist on the NHS, this simply isn’t good enough and change needs to come about sooner to enable access for all.

I support the work of the individual members of MedCan Support who are campaigning on access to this medicine, and I hope to help bring awareness about these issues. I hope to be able to use my voice to help raise funds to support families further with respite, holidays, specialist equipment and providing parents with mental health care if needed.”

Melanie Sykes.






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