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.