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November 1, 2018, was a day for celebration amongst medical cannabis activists in the UK. With one stroke, the British government finally cast aside years of outdated dogma, moving ‘Cannabis Based Medicinal Products’ (CBMPs) from Schedule 1 to Schedule 2. Surely this would herald the access patients around the country had been campaigning for.

Unfortunately, a year has passed and only a handful of patients have actually been prescribed cannabis. And with the recent publication of the overly cautious National Health and Care and Excellence (NICE) guidelines for medical cannabis prescriptions, this looks unlikely to change for a while.

Children with Epilepsy Make History

Like many other countries, the United Kingdom’s belated journey to legalization had at its heart the emotive stories of children with epilepsy whose parents had battled to get access to the plant they believed could save their children’s lives.

In the UK it was Alfie Dingley, the 8-year-old with an extremely rare form of epilepsy. The steroids he was prescribed barely controlled his seizures and would likely lead to psychosis or death, assuming a huge seizure didn’t end his young life first.

With few options left, Alfie’s parents took him to the Netherlands where his seizures were controlled by medical cannabis. When the funds they were using to finance Alfie’s treatment ran out, the family was forced to return to the UK without his cannabis medicine. A high profile media campaign ensued, highlighting the danger to Alfie’s life without access to his lifesaving medicine.

Billy Caldwell, now 14, a Northern Irish boy with autism and intractable epilepsy, also caused a media furore when he returned from Canada, where he’d been receiving treatment. Billy’s  medical cannabis was confiscated and soon his seizures returned, putting then Home Secretary Sajid Javid and the British government in an impossible situation: maintain the official position that cannabis has no medical benefit and therefore cannot be prescribed or acknowledge cannabis needs to be rescheduled so it can be lawfully taken by patients like Alfie and Billy. Thankfully, British officials chose the latter and history was made.

Medical Cannabis Prescriptions Disappointingly Low

One year on and only 122 medical cannabis prescriptions have been written. Which translates to only a handful of patients in the UK having received medical cannabis prescriptions. During this time, NICE, the non-governmental body from the Department of Health, was charged with devising guidelines for the prescription of CBMPs within the National Health Service (NHS).

Coincidentally, 2018 not only marked the reclassification and ostensible legalization of medical cannabis in the UK, it’s also been 70 years since the creation of the NHS, the first ever tax-funded universal health care system, which is now used by 89% of the population.

But the NHS is notoriously stretched, with a finite pot of money barely covering essential services. For that reason, processes are in place such as the NICE guidelines, to ensure that any prescribed medicines are both evidence based and cost effective.

Speaking to Project CBD, Jon Liebling from the Cannabis Patient Advocacy and Support Services, explained that the NICE guidelines “are little more than an algorithm that exists to make sure our NHS uses its money wisely. But they have a process they have been following for many years and all medicines go through that exact same process.”

NICE Says Not Enough Evidence

In order to decide whether there is sufficient evidence proving a drug’s efficacy for a condition, NICE first considers any randomized, double-blind placebo trials (RCTs). If five RCTs exist, other types of evidence, such as observational studies, are not considered.

Liebling: “We must recognise that there is a paucity of high quality randomized controlled data on CBMPs for various conditions. So, all NICE has done is follow their rules, they’ve taken what’s available, plugged that data through their algorithm and out comes ‘yes’ or ‘no’.”

On the 11th of November 2019, just over a year since legalization, NICE finally released their much awaited guidelines. Apart from Sativex for MS-related spasticity, Epidiolex for the rare epilepsy conditions Dravet and Lennox-Gastaut, and Nabilone for intractable chemotherapy-induced nausea and vomiting, CBMPs were not recommended for any other conditions. Notable absences were chronic pain and other types of intractable epilepsy.

In the case of chronic pain, NICE included five RCTs using Sativex (1:1 THC:CBD), a sublingual tincture, for various pain-related pathologies, which showed only a 0.4% improvement in pain on a 0-10 scale at a prohibitively expensive cost. Had NICE included observational data, they might have gotten a different result. The reality is that very few British patients actually use Sativex for chronic pain, saying it is less effective than other medical cannabis formulations and even street cannabis.

Professor Mike Barnes, a consultant neurologist and chair of the Medical Cannabis Clinicians Society, believes efforts by NICE to shoehorn medical cannabis into a process designed for pharmaceutical medicines is a major factor behind the disappointing findings.

“They have their rules and regulations and these do not fit the cannabis plant and they didn’t even recognise that,” says Professor Barnes. “There’s a massive amount of evidence of its usefulness in observational studies. They mention it themselves that for epilepsy there are over 19,000 studies. You can’t dismiss all that evidence and only look at four double blind studies of Epidiolex, which isn’t even a full plant extract.”

Professor Barnes also criticizes the decision to only recommend Epidiolex for Dravet and Lennox Gastaut syndromes, leaving no recourse within the NHS for children with other types of drug-resistant epilepsy.

He says angrily, “You can’t possibly say that for every single epilepsy syndrome we have to have double blind placebo controls. Take Alfie Dingley, who has an exceptionally rare type of epilepsy called PCDH19 and is the only child in the country [with this disease]. Are you going to prevent him having [medical cannabis]? The studies may have been done in Dravet and Lennox-Gastaut, but it’s an anticonvulsant and there’s no reason on earth why it shouldn’t work in other drug-resistant epilepsy syndromes. But they didn’t even recognise that. So, I think it was frankly appalling.”

A sentiment echoed by the Royal Pharmaceutical Society, which called for NICE to consider the inclusion of evidence other than randomized clinical trials, such as observational data and patient case studies, stating, “There needs to be the ability to prescribe for patients in a compassionate way until more detailed data become available.”

Even the notoriously cautious Royal College of Physicians reportedly called NICE’s refusal to recommend medical cannabis products for severe epilepsy a “difficult position” that appears to contradict why the law was changed in the first place.  

Two-Tier System

Another criteria for prescribing medical cannabis, which many believe unnecessarily restricts access, is the stipulation that only medical practitioners on the specialist register can become prescribers. This applies to both the NHS and private healthcare.

In the year since legalization the vast majority of the 122 medical cannabis prescription have come from specialists in the private sector. This sector isn’t bound by the NICE guidelines, creating what many fear is an inevitable ‘two tier system.’

Professor Barnes through the Academy of Medical Cannabis has been responsible for training most of the specialists prescribing medical cannabis since legalization and he fears for patients who cannot fund CBMPs, which cost upwards of £1000 ($1300) a month.

“A lot of people can’t afford it, [so] they’re crowdfunding, they’re selling their businesses, people are selling their houses, particularly for the children. There are families that are going to run out of money at Christmas, and then what are they doing to do? It’s not an exaggeration to say some of those children will die as a result of not being prescribed cannabis medicine. If we’ve got something that will stop their seizures, surely we have a moral duty to give it to them.”

Carly’s Amnesty

With such a small number of patients receiving prescriptions for medical cannabis in the last twelve months, the majority of those in need (estimated at roughly 1.4 million) continue to either buy their medicine from the black market or grow their own, with all the risks that entails.

Carly Barton, despite being the first patient to receive a prescription privately for medical cannabis in the UK, was forced to grow her own cannabis illegally. Carly, who developed fibromyalgia after a stroke at 24, spent six years bedridden and strung out on opioids, until she finally found relief through medical cannabis.

After legalization, Carly soon became the poster girl for chronic pain sufferers hoping to get a prescription for medical cannabis. A protracted journey led her to a dead end via the NHS, until she finally got a medical cannabis prescription from a private pain consultant costing a staggering £1400 ($1800) a month. Carly’s jubilation turned to despair as she realized paying £16,000 ($21,000) a year for her medicine would be financially impossible. With no other options available, she decided to grow her own.

However, Carly wanted to grow her cannabis medicine without fearing arrest. So she launched Carly’s Amnesty, an initiative whereby patients who cannot afford a private prescription can register with local authorities and declare the cannabis they are growing as medicine – with the proviso they hand in any cannabis above their medical needs. In return, they would get immunity from arrest and prosecution.

Carly explains, “At a national level the police force are starting to treat cannabis consumers differently. They now have permission to divert consumers to a treatment program or to simply ignore the offence altogether. We urgently need a precedent to facilitate police exemption for patients. In my opinion, it is a patient’s right to choose growing a plant over taking addictive pharmaceuticals with devastating side effect profiles.”

Privileging Pharmaceuticals over Plants

It’s easy to feel disheartened by a seeming lack of will by UK health regulators to adapt existing systems to the unique nature of the cannabis plant. A few initiatives are in the pipeline such as Project Twenty21, a proposal for a national medical cannabis registry creating a body of evidence that will “demonstrate to policymakers that medical cannabis [products] should be as widely available, and affordable, as other approved medicines for patients who would benefit from them.”

Professor Barnes believes that while currently progress is slow, more patients will ultimately be able to access medical cannabis through the NHS

“If you look at the countries where it’s been introduced, the first year there’s been virtually no pickup at all, mainly because of the reluctance of the medical profession. Second year there’s a little bit, and the third year you begin to move up the curve. I don’t see why it shouldn’t be the same sort of pattern in the UK. I think we’ll see a handful of NHS prescriptions in 2020, then it will begin to pick up in 2021/ 2022 onwards and in four or five years, we’ll begin to think what all the fuss was about.”

Mary Biles, a UK-based journalist, educator, and Project CBD contributing writer, is the author of The CBD Book (Harper Collins, UK). © Copyright, Project CBD. May not be reprinted without permission.

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