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Why we’re taking NICE to court over cannabis denial

The parents of Charlie Hughes have seen cannabis medicine transform their two-year-old’s life. They are now gearing up for a legal battle to help them and other families access the treatment on the NHS.

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Matt Hughes sees Britain’s medical cannabis blockade as the start of a race.

In this race, however, the clinicians and hospital bosses assembled behind the line are not poised to come flying out of the blocks.

Instead they are looking anxiously at their peers waiting to see who will cross the line first that they can chase into the unknown.

Matt and his wife have the biggest possible stake in how this plays out.

Their two-year-old son Charlie has a rare epileptic condition called West syndrome. His life has been transformed by medical cannabis, but the family has been unable to secure it on the NHS, hence a forthcoming court battle and the ongoing financial burden of an expensive private prescription.

Matt says: “As soon as one hospital trust or clinician prescribes, we’re hearing that the flood gates could open. At the moment it’s a question of who’s got the balls to step over the line and make the first prescription?

“They’re all looking at one another, looking for other NHS clinicians that have prescribed.”

Before they discovered cannabis medicine last May, Charlie was having up to 120 seizures a day and was on a regime of four anti-epileptic drugs at any one time.

Now taking cannabis medicine, his seizures are down to 10 to 20-per day and his development is gathering pace. The family followed the ‘start low, go slow’ approach to cannabis medicine, gradually finding the right product and quantity to best manage his condition – and he is in a much better situation now than when he took various anti-epileptic drugs.

“Beforehand, he was either sleeping or, when he was awake, he was just seizing. He wasn’t interacting and you couldn’t really play with him. There was no giggling or little baby noises. It was almost as if we didn’t really know our child, if that makes sense.

“Now, he’s like a different kid. All of a sudden he’s laughing, giggling, interacting and developing. He has speech therapy, physio and is at nursery and the specialists he sees are all saying his development is moving on.”

​This change, while priceless to the family, comes at a hefty financial cost of around £1200 per month. Having been denied access to his treatment on the NHS, the family is taking NICE and  Cambridge University Trust to court in what could be a landmark case.

“This isn’t just about Charlie, it’s about all children with these conditions being able to access medical cannabis. If they did give us a prescription, we hope it would encourage other people to stand up to the trusts and also it could help trusts to feel more confident in prescribing.”

On 1st November 2018  the government moved “cannabis based medicinal products” from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulations 2001.

This enabled doctors on the specialist register to prescribe cannabis. The regulation change allowed for prescriptions for any condition and of any product meeting good quality production standards (EU Good Manufacturing Practice).

Unfortunately, since that point there has been no prescription of a full extract cannabis product on the NHS.

There are a number of speculated reasons for this. Partly there is a perceived lack of support and training around cannabis medicine for doctors, with the endocannabinoid system and cannabis plant rarely taught in medical school.

Also, although not relevant to epilepsy patients specifically, guidelines produced by influential bodies the Royal College of Physicians and NICE are largely negative about cannabis as a pain relief treatment.

Furthermore, an NHS doctor willing to prescribe cannabis needs to gain approval from their trust. But no trust has taken the bold step of agreeing to prescribe.

There is also the added complication that, save for the products Epidyolex and Sativex, cannabis medicine is an unlicensed treatment which means that the prescribing doctor takes more responsibility and liability than usual.

Matt says: “When the law changed, two children that had special licences received prescriptions. But Charlie’s would be the first NHS prescription since the law changed so in that regard it would be a landmark case.”

Cambridge University Hospital NHS Foundation Trust, which guides other local trusts on epilepsy issues, says that guidelines from NICE prevent it from prescribing medical cannabis. But NICE claims it does not prevent doctors making prescriptions where clinically appropriate.

“So our argument is asking whether this is a clinical decision or is it just a ‘no’. Personally, I think the trust appears to be giving us a blanket ‘no’ rather than looking at the individual case. Despite what the law says about clinical decisions, there is no clinical decision being made.

“I’ve spoken to clinicians that say they would prescribe if they could but I think there is a feeling that if they step out of line, their trust will block it anyway.

“Also, a lot of clinicians are prescribing it privately, just not on the NHS. So why is it fine for children to take it privately but for the NHS we need all this extra evidence?

“At the same time, no-one in the NHS is saying this drug is dangerous. At no point, since Charlie’s been on it, has anyone said it’s dangerous and he shouldn’t be on it.”

The family is taking considerable risk in pursuing legal action.

While they have received some legal aid, they would be liable for the legal costs of NICE and the trust, which Matt estimates could be upwards of £20,000.

Over £11lk has been donated to the family via the legal fundraising platform Crowd Justice to help them in the battle ahead.

Lawyer Nusrat Zar, of Herbert Smith Freehills, stated in the Mirror newspaper that the aim of the case is to “ask the court to rule that the refusal to offer the drug is unlawful”.

She explained: “Legally, a decision doesn’t oblige the hospital to give the drug. But public bodies like the NHS are good in taking on board such decisions.”

At the time of writing no court date has been set, with COVID-19 continuing to cause havoc to all such processes.

In the meantime, Matt and his wife are supporting other parents in navigating their own access to medical cannabis.

“We understand the processes and laws now and pass everything on to other families about what we’ve learned in fighting to get the medicine.”

Donate to the Hughes family and read their full story here.

Cannabis Health is THE UK magazine covering cannabis medicine and wellbeing from every angle. It is affiliated with the Medical Cannabis Clinicians Society and lists campaigner Hannah Deacon and leading expert Professor Mike Barnes on our editorial panel. For a limited time only, we are offering a free – absolutely no strings – annual subscription to the quarterly print title. You will  receive four issues, delivered with discretion to your address – with no hidden fees or obligation to pay beyond that. To repeat, this is a 100% free promotion available to the first 100,000 sign-ups.

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Case Studies

Save your HRT, give me CBD

Going through the menopause hit Jenny hard, with an array of side-effects leaving her exhausted and wanting to hide from the world. Here, she shares her story of how CBD is helping her to rediscover the fun-loving woman she used to be.

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As a woman in my 50s, it’s perfectly normal to be going through the menopause. But while I’ve always known it was coming, I had never appreciated how bad it would actually be.

Menopause, as all the women’s magazines tell you, happens to us all. A few hot flushes, bit of difficulty sleeping, stick on an HRT patch and you’ll get through.

For many that may well be the case, but the reality for me has been so much worse.

The sweating at night has to be one of the most awful parts. Waking up night after night, dripping in sweat, the bed sheets drenched, has become the normal over the past 18 months.

And once I’m up during the night, I can’t get back to sleep. Regularly I get up at 3 or 4am, and go downstairs to watch whatever appallingly bad TV shows are shown at that hour.

I’ll then find myself falling asleep during the day if I’m at home, which I feel is me slipping further down the slope into old age.

Hot flushes happen all of the time. And when we say hot, it’s not just a case of taking your cardigan off, the heat is incredible.

Regularly I’ll be out at lunch, sitting in just a camisole while everyone else is in jumpers, fanning myself down with whatever beer mat or menu card comes to hand.

I may as well just have Menopausal Woman written on my top as it’s so obvious.

I didn’t think the menopause would affect me so much, and I also didn’t expect to cope this badly with it.

I have always had a fantastic social life, going to dinners and lunches several times a week, and I love getting dressed up.

Since the onset of my menopause, with the tiredness and the unexpected hot flushes in particular, I’ve lost my enjoyment of it all.

The worry you’re going to fall asleep at the dinner table (that has happened before, but thankfully in my own home) or aren’t going to feel great when you’re there has seen me decline so many invitations.

Friends are asking whether I’m OK, whether I’m ‘me’, as this is so out of character.

And in truth, over the last 18 months, I do feel like I’ve lost my old self to quite an extent – although in the last few weeks, I do feel like I’m getting her back thanks to a chance discovery while online shopping.

While browsing for some new shoes, I hadn’t felt like going out that day, I came across one of those pop-up adverts for CBD.

I knew it was associated with cannabis but didn’t really know much more than that, but I continued to shop for heels and forgot about it.

That night, again, I couldn’t sleep. Having watched three back to back Judge Judy episodes, which is surely enough for anyone, that CBD advert came into my mind again.

I’d read a lot about cannabis over the past few years and the wonderful effect it had had on so many children.

I’d never had a personal interest in or connection to cannabis, but the fact people in desperate need had been denied it was something I believed was wrong.

For some reason, I decided to search CBD and menopause. HRT for me had been rubbish, so it was worth some investigation at least.

To my astonishment, there were so many stories about the strong connection between the two, the many benefits there could be, how CBD could help with so many symptoms.

I couldn’t believe it. I’m not sure I believe in fate, but there was a reason that random advert popped up on my shoe site that day.

I bought some CBD in my local shopping centre – it’s perfectly legal and readily available, which is something I hadn’t realised.

I thought it must have been a banned substance because of how it’s spoken about in whispers.

It’s not something I feel I could tell my friends I’m using as I’m not sure how they’d react. But discovering CBD has been the most fantastic thing to happen to me in a long while.

The past few weeks have been so much better. I have enjoyed a good sleep for the first time since my menopause symptoms began and am sleeping through the night again.

I’ve also felt so much better in myself, like I want to make an effort and put my make up on and put some nice clothes on.

If I had anywhere to go at present, I’d love to put my heels and best dresses on and get back out there. While I still have hot flushes they haven’t been anywhere near the extent they were before.

This is probably due in great part to the fact I’m sleeping, and sleep is at the root of so much in terms of quality of life, but CBD is said to have mood lifting properties, so that could well be another benefit.

Nothing else in my routine has changed apart from my use of CBD so I can only conclude that is the reason.

The difference in only a few weeks has been a great surprise. I do feel like I have the confidence to start accepting those invitations again.

The COVID-19 lockdown has come at a good time for me, as CBD is doing its thing for me, and I’m getting myself back to a position where I feel like ‘me’ again.

There is undoubtedly a taboo around the use of CBD, which I think is unwarranted.

I think we are far too closed-minded as a society and we don’t talk about these things which seem a bit awkward.

Even trying to discuss the menopause with some people is a conversation-changer in itself.

I do think I’d get some difficult reactions if I talked about my CBD use, which is a real shame.

Id love to share my CBD secret with my friends, and perhaps I will at some point. Or perhaps theyre all already using it anyway.

Jenny did not wish to give her full name.

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Case Studies

CBD oil and fibromyalgia – a case study

Fibromyalgia is a neurological condition where inappropriate nerve signals produced in the brain cause widespread pain, aching, tingling, burning, throbbing and stabbing pains…

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Sufferers experience up to five times the pain of non-sufferers. Sometimes the slightest touch is agony. There are many other symptoms that come along with fibro including chronic fatigue, muscle spasms, blurred vision, ‘brain fog’, IBS, sleep problems, migraines, poor balance, shortness of breath, restless legs, etc.

The cause of fibromyalgia is unknown. It’s believed that people who have this condition process pain differently, and that the way their brains recognise pain signals makes them overly sensitive to touch and other stimuli.

Some people believe fibromyalgia is a new condition, but it’s existed for centuries. The disease can affect anyone, including children, but it’s more common in adults. Women are diagnosed with fibromyalgia more often than men.

There is no cure for fibromyalgia, but medication, some lifestyle changes, and natural remedies can help people manage the symptoms. Research is ongoing, nonetheless, CBD remains a popular choice and there is little doubt that an increasing number of people are turning to CBD oil to help symptoms of fibromyalgia.

The pain-relieving effects of CBD may be explained by the ways that this substance affects the brain. It may interrupt the nerve pathways that send signals of pain between the brain and the body.

The anti-inflammatory action of CBD appears to reduce heat and swelling around injury or disease which, in turn. would reduce pain.  It is suggested that a lack of endocannabinoids — neurotransmitters that bind to cannabinoid receptors — may be at the root of chronic pain syndromes, including migraines and fibromyalgia. Taking CBD may correct this deficiency, explaining the compound’s success in alleviating chronic pain.

Fiona’s story

Life altered dramatically for Fiona Henry (pictured above) when she started to experience symptoms of fibromyalgia. As her world was turned upside down in so many ways by this debilitating condition, and as she battled to get through each agonising day, she desperately sought help from anywhere she could find. Here, she shares her story; the struggles, the torment, the fears … and her gratitude for the eventual solace she discovered through taking CBD.

Before the onset of fibromyalgia, I was a fit person, always ‘on the go’, enjoying time at the gym and a keen runner, even participating in The Great Northern Run.

‘It felt like I had cement running through my veins.’

My husband had to come and carry me out of work as I could no longer lift my arms and legs, and I couldn’t speak.

It felt like I had cement running through my veins and my eyelids felt like they had great big weights on them.

Once the illness took over, I initially endeavoured to continue with my career as a senior beauty therapist, trying to push through it, yet this only made the symptoms worse and eventually, when I was so fatigued that I couldn’t move, I was forced to give up the job I loved.

‘I felt as though I was trapped in my own body. It was terrifying and incredibly isolating.’

The loss of my career was devastating. The impact on my life was immense as everything I knew and looked forward to before now had to change.

My husband became my carer, something he had to deal with on top of working in two jobs, taking on all the roles that I had always managed, like food shopping, cleaning and cooking.

I couldn’t look after myself at all. At my worst, I was completely bed-bound, temporarily paralysed, unable to tolerate the smallest amount of noise and light.

I felt as though I was trapped in my own body. It was terrifying and incredibly isolating.

I could no longer go out dancing all night with my friends like I used to. I’ve gone from running half marathons to not being able to walk more than 100 yards, using a walking stick and recently needing a wheelchair to get around.

I have two toy poodles who are my life but the joyful walks together became a pleasure of the past. Instead, I would strive to just cross the road and sit on the bench so that I could watch them play.

I’ve always been the one busily looking after everyone else but now I had to rely on others for help, something that I struggled to adjust to and always found difficult to accept.

It was heart-breaking for me, not being able to make a fuss of people like I used to, feeling guilty for not being able to help out and do things in the way I used to.

When I was finally diagnosed it was a sense of relief. I had known deep down that I had fibro for a while and this gave me the opportunity to be able to manage my symptoms properly.

I was diagnosed with M.E first and then I developed the pains and was also diagnosed with fibro.

I have to rest as much as possible, between little bouts of activity, conserving the energy that I do have for managing my symptoms and trying to get better.

I have learnt to listen to my body as trying to ignore it has only made things tougher. I am pacing myself and accepting this new norm, whilst still finding ways to enjoy myself.

After finding out that I had fibromyalgia, I joined a few support groups on Facebook and alternative therapies were often mentioned. Living with pain and fatigue is something I have sadly become accustomed to, and I was willing to try anything that might help me. I began to consider taking CBD.

Finding Hapi Hemp was a bizarre coincidence! My aunt was in Cambridgeshire visiting her son and his wife and through conversation, I discovered that she knew one of the Hapi Hemp business owners!. I couldn’t believe it, as I had literally been looking at their website for the past week!

 ‘I couldn’t imagine life without CBD oil!’

CBD changed everything for me. It is not a miracle cure but it really does make such a huge difference to my ability to manage the condition.

I have become a CBD fan in every which way – taking oral drops and drinking the CBD tea, I also use the CBD bath salts and massage oil. And the CBD roller goes everywhere with me!

CBD oil helps with every single symptom I have; I sleep better and wake up more refreshed. It eases my pains, gets rid of tinnitus, helps lessen migraine attacks, calms me down, and got rid of restless leg syndrome.

Overall, I would say that I just feel more alive! I really can’t imagine life without Hapi Hemp CBD Oil!

 

Cannabis Health is THE UK magazine covering cannabis medicine and wellbeing from every angle. It is affiliated with the Medical Cannabis Clinicians Society and lists campaigner Hannah Deacon, leading expert Professor Mike Barnes and prominent doctor Dani Gordon on our editorial panel. For a limited time only, we are offering a free – absolutely no strings – annual subscription to the quarterly print title. You will  receive four issues, delivered with discretion to your address – with no hidden fees or obligation to pay beyond that. To repeat, this is a 100% free promotion available to the first 100,000 sign-ups.

Claim your free subscription now!

 

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Case Studies

Where there’s a Will, there’s a way

Brave William Frost was given less than six months to live when his terminal condition progressed. Then his parents discovered CBD, and a special diet, and everything changed, as Andrew Mernin reports.

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The Frost family were reluctant tabloid headliners in spring 2017. ‘Tot shocks docs,’ declared the Sun newspaper. ‘Boy’s aggressive brain tumour shrinks thanks to CANNABIS compound, parents claim,’ it continued.

The boy in question, William, now seven, did indeed experience remarkable results in tackling a terminal condition after taking cannabis oil.

But the Frosts were somewhat uncomfortable with their moment of red top heat.

The message that ‘cannabis cures cancer’, as the story seemed to pronounce to the world, could be dangerous and misleading; and the column inches devoted to William didn’t reveal the full picture of his journey.

Dad Stephen has since made it his mission to help uncover the true facts about the potential role cannabis can play in fighting paediatric brain tumours.

The family’s charity, Make William Well, has helped to raise £100,000 to support ground-breaking research on the topic; and Stephen is now a regular speaker at insight- sharing events focused on childhood cancers and their possible links to cannabis treatments.

“It’s been so much of a rollercoaster over the last few years that our emotions are almost blunted or exhausted. You can’t really describe how it feels,” he says over the noise of a busy coffee shop near the family home.

“We were basically told he had a brain tumour and probably had five years to live. It was utterly devastating.”

It all started innocuously with little signs; the type fretted over by young parents but downplayed by doctors. William was 18 months old and had just started nursery when he began experiencing sickness and teething issues commonly seen in toddlers.

But he was also finding balancing unusually difficult for a child of his age, and walking with his head tilted to one side.

After several trips to the GP, he was referred to the local eye, ear, nose and throat (EENT) department.

But his parents felt a looming sense that his condition was more serious than the speculated ear problem.

“My wife had been on the headsmart.org.uk website, which supports the early diagnosis of brain tumours, and William had some of the symptoms. Then one night I picked him up and he threw up on me for no apparent reason. That was it, we thought there was something seriously not right here.

“We went to accident and emergency and after a week of tests in which they could find nothing wrong with him, they finally agreed to do an MRI scan. That’s when they found the tumour.

“We were told it was terminal and that there was a five year survival rate. If he had surgery and they could get it out then he might have a chance at longer than that. But if they didn’t, then it would be much shorter.”

The tumour was around the size of a golf ball, near to the centre of his brain. It was diagnosed as a ‘grade three anaplastic ependymoma of the fourth ventricle’. Within days, William was taken into surgery at Queens Medical Centre, Nottingham, and the tumour was removed.

Due to its proximity to critical nerves, however, he was left with partial paralysis on his left hand side. This meant he couldn’t move this side of his face, or swallow properly, and had to be tube fed.

Because of the grade of the tumour there was a significant chance it would likely come back so further treatment was required. William started chemotherapy, but was unable to tolerate the full planned 13 months of treatment.

He was already deaf in his left side, possibly as a result of surgery, and was beginning to lose high tone hearing in his right side, likely due to the chemotherapy. Treatment therefore ceased after nine months.

But the family received the welcomed news that tumour had been “fully resected” and there was no sign of regrowth.

Stephen says: “I don’t think the outlook ever really changed but we were hopeful. We pushed the idea that it could return to the back of our minds and hoped that we’d got it. As a parent, if you’re told its fully resected and your child’s had chemo too, you kind of hope that that’s it. But obviously the cancer was a particularly nasty one.

“He was still a bit wobbly on his feet at the time, but he made a good fight of doing the things other children get up to at that age, like going to playgroup and so on.”

When his balance problems worsened, their underlying fears that the tumour would regrow were realised – and this time it was in an even more precarious place, tangled around the brain stem.

The only option was a “very risky” surgery, which successfully removed most, but not all, of the tumour. The family were then told that William could be considered for Proton Beam Therapy in America. This is a less damaging form of radiotherapy than that offered in the UK.

Yet, although the NHS had approved funding, the centre in America ultimately denied treatment him due to his tracheostomy and the possible complications of travelling to America.

In the meantime, the tumour had regrown exponentially since the surgery. William was fast-tracked onto a six week course of radiotherapy during which sickness was a constant issue.

But the tumour was increasing in size and, despite going through another round of chemotherapy, it’s growth could not be stopped. Doctors gave the family the heart-breaking news that there were no other treatment options available.

“They said, ‘unfortunately that’s it’ and they gave us details of a hospice. We were told that William only had six months maximum left and wouldn’t live to see Christmas.”

And so began a desperate hunt for alternatives beyond what was available on the NHS.

One glimmer of hope was that William’s tumour had the correct profile for the ketogenic diet to possibly have an effect. This is a high-fat, adequate-protein, low- carbohydrate diet sometimes used to control severe childhood epilepsy.

But Stephen and his wife’s search also brought them to CBD.

“We didn’t know at the time if it was possible to go down the THC route, or how we could get hold of it, or CBD that we could trust. This was in 2016 before CBD had become readily available.

“We spoke to our consultant who couldn’t recommend it and said not to bother with it because it hadn’t been through preliminary trials.” Ignoring this advice, they found a private clinic offering a synthetic CBD treatment, which they decided to try in conjunction with the ketogenic diet.

“This was the only way we could get hold of what we could trust was CBD and they charged us a lot of money for quite a small amount.

Then six months after being told nothing more could be done for William, they noticed an improvement in his condition.

An MRI scan revealed that his tumour had shrunk to around a third of its original size.

“We don’t know what worked exactly, but we know the tumour shrank. Was it the CBD? Was it a combination of this and the ketogenic diet? Radiotherapists even argue that it could be delayed effects from the radiotherapy, which would be surprising given how long after the radiotherapy it occurred.

“We don’t know whether there was a synergistic effect between the CBD, the diet and the delayed effects of the radiotherapy.”

The tumour remained stable at its reduced size for around 18 months until scans showed that it had started growing again. William underwent another surgery, removing almost all of the tumour, before more chemotherapy.

He continued on cannabinoids and the ketogenic diet and, by late last year, his scans were clear.

He now takes a non-synthetic CBD product containing more cannabinoids than his previous regime, with the aim of killing the remains of the tumour.

He is also undergoing metronomic chemotherapy (lower dosage with less side-effects) continuing on the ketogenic diet alongside his dad.

“We hope this will keep it under control but I’ve also read certain lab-based studies that suggest it can actually be killed by cannabinoids. That’s the hope.”

The family’s charity, Make William Well, has teamed up with Brain Tumour Charity to raise funds for vital research that could ultimately shape treatments for other children like William.

It has helped to raise over £100,000 for ongoing research led by the Children’s Brain Tumour Research Centre at the University of Nottingham.

The research aims to answer the question: Is there a role for cannabidiol in the treatment of children’s brain tumours? The researchers say: “CBD is widely used by brain tumour patients, sometimes with considerable success. But, we need to objectively understand how CBD affects the cells, and why the results patients and families are reporting occur.

“This knowledge is essential in order to determine what the therapeutic dose of CBD might be. Without this, clinicians or families may inadvertently be too conservative or liberal in their dosage, and not achieve optimum results for the patient.”

Stephen is hopeful that other cannabinoids, including THC, might also be included in such research in future.

“From the outset in pushing for this, our aim was to get all cannabinoids researched so that eventually they can be issued free of charge on the NHS once they’ve gone through the clinical trials.”

Specific areas of the soon-to-be-concluded lab-based studies include to what extent oxygen levels in tumour cells treated with CBD, have on markers within the cell which indicate the beginning of the process of cell death.

Also, some patients are taking cannabis oil as an adjuvant therapy (applied after an initial cancer treatment) for their brain tumour.

The treatment is to take the oil for CBD three days on and three days off. But it is not yet understood how this action affects tumour cells. Furthermore, the researchers have investigated in further detail how CBD affects the cell receptors, to better understand the effect the drug has on tumour cells.

According to the researchers: “This research could have considerable clinical benefits, and therefore it is very important that any conclusions we draw are able to stand up to international scientific scrutiny.

“To achieve this, we are now in the process of detailed examining all  of our data from the project.”

The findings are expected imminently, from a study which is underpinned by global collaboration.

Lead researcher Professor Richard Grundy visited The University of Western Australia as part of the study to learn first-hand about their CBD research studies focussing on medulloblastoma.

He spent time with Dr Clara Andradas Arias, an international post-doctoral researcher in the Brain Tumour Research Lab at Telethon Kids Institute in Perth.

This international collaboration has enabled the sharing of data on how CBD affects cells in paediatric tumours. Further studies include a planned ketogenic diet and CBD clinical trial, which is hopefully taking place this year.

More generally, as UK health authorities continue to call for more evidence of the medical benefits of cannabis, Stephen would like to see investment in “adaptive clinical trials”.

These are trials in which modifications in response to the participant’s outcomes and other factors such as side effects are allowed after it has begun, without its validity or integrity being questioned.

They are distinct from ‘double-blind, placebo-controlled clinical trials’ which are considered the gold standard in medical testing and typically relied upon by the pharmaceutical industry to prove the benefits of new drugs.

Doctors and campaigners who advocate medicinal cannabis argue that such trials are not compatible with cannabis medicine. They argue that the plant is too complex and is not a single molecule pharmaceutical product that these trials are designed for.

They also point to the growing body of observational and case study data supporting the use of medicinal cannabis to treat various conditions.

Stephen says: “Why are such clinical trials the gold standard? They take too long, are too expensive and clearly haven’t been very good in terms of coming up with effective treatments for childhood brain tumours.

“Adaptive clinical trials, which are far cheaper and produce faster results, should be carried out on a multitude of cannabinoids. This way more children could be given the opportunity of sooner access to paid- for quality assured medicinal cannabis products under close clinical supervision.

“I believe the current system of gold standard trials has failed our children – only one drug has ever been specifically developed to treat a childhood brain tumour.

“There are hundreds of papers written about cannabinoids and the evidence that it works in the lab is overwhelming. But there just aren’t the gold standard clinical trials.

“There are just four drugs that have ever been developed specifically for childhood brain tumours, the rest are hand-me-down treatments from adult cancers, which are very different biologically to their childhood equivalents.

“We are cutting, burning, and poisoning our children with decades old inappropriate approaches when cannabinoids are starting to be shown to be potentially effective but are currently a long way off being prescribed on the NHS.

“I believe there needs to be a sea-change in the way we go about looking for childhood cancer cures and I believe that pushing for adaptive clinical trials is the way forward.”

While continuing to push for research, Stephen is also regularly contacted by parents of other children facing similar challenges to William.

“I try to help, and I get a lot of questions about dosages, but I would never recommend one thing or the other. There’s generally massive confusion out there about cannabis medicine.

“A lot of people think, like I did before we went through all this, that the whole medicinal cannabis campaign is just led by people wanting to legalise marijuana for recreational use.

“They don’t see the evidence which proves that it can work on brain tumours, certainly in the lab. For whatever reason, the clinical research isn’t getting done and that’s now why we’re campaigning.

“Its one thing getting it legalised, but without the research you’re still not going to know about the dosages or side- effects. If I was a doctor I wouldn’t want to give a drug that hadn’t been through clinical trials. Also, different cannabinoids could have different effects on different cancers. This is where the research needs to go and in a way that reflects the complexities of the plant.

“What we want to do with Make William Well is to say ‘there is a potential new advancement here, let’s get the focus on kids.’ Three years ago I didn’t think we’d have a chance of getting a research study done, yet we proposed it, the centre agreed to it and we helped to raise the funds to do it. After that we didn’t think there was a cat in hell’s chance that we’d ever be looking at clinical trials, but now that’s hopefully realistic as well.”

To donate to Make William Well visit www.makewilliamwell.com.

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