Tuesday, September 27, 2022

Law and ordering—championing NHS medical cannabis prescriptions

Like green shoots in the garden, at the turn of the year evidence of societal changes in attitudes to medicinal and therapeutic cannabis are emerging. Those shoots may look fragile, but the stored energy in the bulbs and the returning sun will bring flowers soon. Has the movement to enable NHS prescribing of medicinal cannabis to all the patients who would benefit from it got similar resilience and strength to effect change? In the three years since it became legal for the NHS to prescribe unlicensed medical cannabis, only three patients have received prescriptions. The gap between legal and functional needs to be bridged. What progress is being made?

One green shoot was indicated by Jeff Smith MP’s private member’s bill (PMB), the Medical Cannabis (Access) Bill, in December. It offered ways of tackling the systemic problems which are causing the slow rate of prescribing. The bill did not have government backing, and so was talked out without a vote, but the debate itself demonstrated cross-party, informed support among MPs. Labour MP Mr Smith has co-chaired the all-party parliamentary group (APPG) for drug policy reform since 2011 with Conservative MP Crispin Blunt. Mr Blunt spoke in support of the PMB in the debate, as did other Conservative MPs. In 2018 an APPG for access to medical cannabis under prescription was set up, and most recently, in November 2021, an APPG for CBD (cannabidiol) products was established with Mr Blunt as co-chair and Mr Smith as an officer. Labour, Conservative, Scottish National Party, Liberal Democrat and Green MPs are taking an active interest in medicinal cannabis and/or CBD, and drugs policy reform. While the government didn’t back this bill, it has instigated various expert reports relating to medicinal cannabis and CBD, the latest of which is research and analysis by the Advisory Council on the Misuse of Drugs (ACMD), Consumer cannabidiol (CBD) products report, updated on Tuesday 20 December. It appears that the knowledge-base of these matters in political circles is deepening and broadening.

Jeff Smith MP (Labour) used his private member’s bill to put forward proposals to enable access to medicinal cannabis for NHS patients—it is three years since it became legal to prescribe unlicensed CBMP on the NHS, but so far only three people have been given prescriptions owing to the difficulties within the wider prescribing system

Another green shoot is evidence of ‘joining the dots’ between patients, parents, medics, scientists, industry, campaigning groups and politicians. Whereas only a few years ago, there were individual voices crying in the wilderness, now there are clear links between groups. A few days after the PMB was debated, a group of scientists from Imperial College, London, published research in the BMJ into the use of whole plant cannabis medicines in ten cases of children suffering from severe treatment-resistant epilepsy (STRE). The four scientists who undertook the research are all involved with the charity Drug Science, and one is its chair, Professor David Nutt. During the PMB debate, Mr Smith declared an interest in that he is a trustee of Drug Science. (None of them is paid by the charity.) The children who participated in the study were recruited from two campaigning groups, MedCann Support and End Our Pain. The secretariat of the APPG for medical cannabis is End Our Pain. The secretariat of the APPG for CBD products is Tenacious Labs, a business in the CBD industry. Connections between interested groups are becoming clearer and stronger, forming effective networks.

The Imperial College research was published shortly after the furore about Owen Paterson’s resignation as an MP following disclosures that he had been paid by companies on whose behalf he lobbied the government. The public is sensitised to possible corruption or MPs lining their own pockets or those of their friends, with concerns about sourcing medical products such as PPE. Drug Science is described on its website as, “the leading independent scientific body on drugs in the UK. We work to provide evidence-based information without political or commercial interference.” In the BMJ research it is noted that Drug Science receives “an unrestricted educational grant from a consortium of medical cannabis companies to further its mission, which is the pursuit of an unbiased and scientific assessment of drugs regardless of their regulatory class”. This statement suggests that in this instance the ‘dots’ between independent science and industry are being joined with probity, so that a funding-stream from businesses is enabling academic research with no commercial strings attached.

“We work to provide evidence-based information without political or commercial interference”

Drugs Science

The overriding concern of these interested groups is that despite the change in the law on 1 November 2018, allowing NHS prescriptions to be written for unlicensed cannabis-based products for medicinal use (CBMP aka CBPM), only three such prescriptions have been written in the intervening three years according to campaigning charity End Our Pain.

Hope was raised in 2018 among the families of children suffering from STRE that NHS prescriptions would soon be available to them, but the change in the law came so rapidly that the rest of the vast medical and prescribing system was not ready. Clinicians reported being taken by surprise. Procedures used to ensure that medicines prescribed by the NHS are safe and value for money could not easily accommodate these unlicensed medicines. There was not the body of conventional evidence underpinning them that organisations such as CCGs or NICE expect. While families could see the transformative effect CBMP had on their children, a system which relies on randomised controlled trials (RCT) of drugs was not ready to prescribe.

Since legalisation, figures supplied by ACMD have shown increasing numbers of prescriptions, but these are being privately funded by patients, at eye-watering cost. In a report published in November 2020 (2.9ff), ACMD notes that in the year before the change in the law on 1 November 2018, the number of patients in the UK prescribed unlicensed CBMP (through clinical trials and/or under a Home Office licence, for instance) was fewer than 13 (178 items dispensed), all on the NHS and none private. In the following year it was fewer than nine NHS patients, and 75 private patients (452 items dispensed); the percentage of private patients was therefore at least 90%, leading the report to conclude that “The vast majority…were issued privately.” The number of NHS patients is not precise: the total is so low that patients might be identifiable were the number published. The report describes the figures as “<5” for each of England and Northern Ireland.

Similarly, the Care Quality Commission is cited in the report as stating that unlicensed CBMP items prescribed privately as a percentage of the total rose steadily month-by-month from 67% in January 2019 to 98% in the following December.

Owing to complications arising from the covid pandemic, the figures for November 2019-October 2020 were harder to access, but referring to England alone the ACMD report says estimated numbers of private prescriptions could have reached between 400 and 600 items; “This would equate to an estimate of between 149 and 224 unique patients projected to have been privately prescribed unlicensed CBMP in England over the course of that year.”

In England alone, this represents an estimated increase of between 136% and 256% in the number of patients paying for private prescriptions from the year ending 31 October 2019 to the year ending 31 October 2020. This indicates that between the first and second years of legal prescribing, the numbers of private patients had at least doubled, and may well have more than tripled.

Billy Caldwell was the first to receive an NHS prescription for medicinal cannabis—one of only two children in the UK to get one; he is pictured with his mother Charlotte who has been an indefatigable campaigner for access to CBMP, setting up the I am Billy Foundation

Another green shoot is that there is a will to collate evidence of the number and cost of the slew of private prescriptions which have followed legalisation of unlicensed CBMP, while NHS ones are so difficult to access. As well as assessing the health impact of CBMP on patients, the team from Imperial College (Rayyan Zafar, Anne Schlag, Lawrence Phillips and David J Nutt) considered the financial burden of private prescriptions in their 2021 research. Of the ten children studied, one was in receipt of an NHS prescription; the other nine had to finance their own. Different medicines cost different amounts, and quantity required makes a difference too. The highest monthly cost was £1,600, and the mean figure including the zero-cost NHS prescription was £874. (The mean cost to the nine paying patients was therefore £971.) In a previous study of ten patients aged between two and 48 published by Sage Journals in 2020 (Zafar, Schlag and Nutt),the highest monthly cost was £2,620 and the average £1,816.20. In the 2020 study all patients were prescribed the medications Bedrolite and Bedica.

The 2021 research notes that cost is obliging some families to switch their children’s medication away from Bedrolite and Bedica, even though they have found them efficacious in reducing seizure frequency, to cheaper CBMPs. Medical consequences were noted: “[Another] patient saw a significant worsening of symptoms including an increase in seizure frequency when switching from Bedrolite and Bedica products to other whole-plant CBMPs” states the study.

The appalling financial burden families are shouldering was mentioned time and again during the PMB debate. While the necessary procedures are put in place to enable the NHS to prescribe CBMP readily, money is needed to help the patients who are only able to access private prescriptions. It appears that a change of minister has stymied attempts to come up with funds. Tonia Antoniazzi MP (Labour), the chair of the APPG for access to medical cannabis under prescription, said, “We have asked for a pot of money. We went to the Department of Health and Social Care. The hon. member for Bury St Edmunds (Jo Churchill) was on the verge of organising it and getting it sorted so that we could have that pot of money. The bill was the next option, because that option was no longer available when she was replaced as minister. What next? There are 20 families, and hundreds more, who need something to happen. Inertia is not what we want. We have to move on. What is being done by the government?”

The current minister, Maggie Throup MP (Conservative) Parliamentary Under Secretary of State (Minister for Vaccines and Public Health) was at the debate but didn’t speak, so there was no clear explanation of why the government was not supporting the bill, nor funding the ‘pot of money’. This is where it appears the ‘dots’ are not joining.

“inflexibility in the system…is at the root of the problem”

Jeff Smith MP

In Mr Smith’s opening speech, he stated that, “I had hoped to agree an approach with the government. I had a number of conversations with ministers. I do believe that ministers want to find a way forward on this but, unfortunately, that has not been possible, which is why I have put forward the proposals that are before us today. As I say, I do not think there is a lack of will from the government, but that reflects an inflexibility in the system, which is at the root of the problem.”

The present pace of tackling the problems appears glacially slow in comparison with the swift action taken by Sajid Javid, the current Secretary of State for Health and Social Care, when as Home Secretary in June 2018 he issued an emergency licence to allow Billy Caldwell to access the CBMP brought home from Canada but seized by border officials when he landed in Heathrow. Without it he was suffering some 100 seizures a day.

Research by a team from Imperial College, London, published in the BMJ, noted a mean 86% reduction in monthly seizure frequency in the ten participants following initiation of medical cannabis

The Imperial College research assessed “the percentage change in monthly seizure frequency in participants following initiation of medical cannabis” and secondarily “the impact of medical cannabis on changes in AED use…” (AEDs are conventional anti-epileptic drugs, which have known side-effects noted in the study, including a large decrease in global IQ and verbal learning, behavioural problems and somnolence.)

Seizure frequency reduced by a mean of 86% across the ten patients. One went from 600 per month to zero. The patient with the highest number of seizures saw a reduction of 80% from 2,800 per month to 560.

Patients reported a mean of seven AEDs prior to starting CBMP, which reduced to a mean of one per patient, with seven of the ten patients managing to wean off all AEDs.

“Carers reported sustained and significant improvements in behavioural, psychological and cognitive faculties associated with medical cannabis use,” stated the study. A follow-up study asked parents about any adverse effects: only a few minor ones were noted, “such as tiredness before exact dosing”.

The authors described the limitations of the study: retrospective data collection (though often with reference to seizure diaries), no randomisation or placebo, parents who agreed to take part might be ones whose children had benefited from CBMP, no assessment of the impact of removing medication, and the small number of the study group.

“the mean reduction in monthly seizures is very high in both studies: 97% in 2020 and 86% in 2021”

Despite the limitations outlined, this research, and that published in 2020, is another green shoot. While the numbers of patients are small, the mean reduction in monthly seizures is very high in both studies: 97% in 2020 and 86% in 2021. The RCT double-blind trials required by the present prescribing system are not suitable in cases of STRE as some children would have to stop taking the very medication which dramatically reduces their seizure rate, and their lives could be threatened. 

This small-scale research indicates other avenues of research, according to the authors of the research: “Further research is required to elucidate the mechanisms by which the respective additive constituents of whole-plant products lead to superior clinical results.” 

Children with STRE are not the only people to find relief of symptoms through CBMP, but their suffering is so acute, and the lives of their families so challenging, that their experiences figure large in any discussion about legalising and accessing these medicines. The five-hour debate in the House of Commons on the Medical Cannabis (Access) Bill on Friday 10 December detailed the difficult cases of children with STRE and their families who are constituents of the MPs taking part. Some MPs spoke of constituents with other medical issues from migraine to progressive myelopathy who benefit from CBMP.

The five hour debate on the talked-out Medical Cannabis (Access) Bill is recorded in Hansard, and makes fascinating reading, full of accounts of constituents’ struggles to access CBMP and the dramatic relief it gives them—just right for a long train journey, or waiting for a flight

The PMB presented by Mr Smith was to “Make provision about access to cannabis for medical reasons; and for connected purposes.”

At present only medical specialist consultants can prescribe CBMP. The bill proposed amending the Medical Act 1983 and the Misuse of Drugs Regulations 2001 to allow some GPs to prescribe CBMP too. The General Medical Council would be tasked with operating a register of these practitioners, and detailing criteria for inclusion and associated training.

A further proposal was for the Secretary of State for Health and Social Care to establish a commission on CBMP which would:

  • 1 (a)  propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England, and 
  • (b)  make recommendations of measures to overcome barriers to access to cannabis from the National Health Service in England for medical reasons. 

Assessment methods to be considered would include “observational studies, conventional controlled trials, and other countries in which CBMP are more widely available”.  Whole-plant products would be included. Statutory bodies, professional and interest groups would be consulted. The commission would include people from various fields of expertise.

Speaking to the House, Mr Smith outlined the likely extent of a GP’s role in prescribing CBMPs: “I should perhaps be clear that I am not expecting GPs to initiate a prescription for some of the very rare and specialist conditions, such as some of the epilepsy conditions we have talked about, although for childhood epilepsy GPs are currently allowed to continue a prescription that has been initiated by a specialist. Many other conditions that can be effectively treated by cannabis-based medicines, however, are what we might call GP conditions, and chronic pain would be one of them. Enabling trained GPs to prescribe medical cannabis should improve access for patients with symptoms commonly dealt with by GPs, such as chronic pain, muscle spasms, nausea and anxiety.”

He also offered clarification about whether the proposed commission would add another layer of bureaucracy to the health system: “I emphasise that I am not proposing a new permanent body; this would be a bit like a royal commission, although I would want it to be much shorter and more focused. It would be a commission of experts to look at the problem and propose a new framework for assessment of the evidence. That would, I hope, lead to a better process for licensing.”

Dr Kieran Mullan MP (Conservative), one of those opposing the bill, said, “Labour members want unlicensed treatments to be brought forward.”

“a bill that will enable clinicians to look at wider evidence in order to get those medicines licensed”

Jeff Smith MP

Mr Smith offered clarification: “I have not proposed the bill to try to have unlicensed medicines—as I think he said—put forward. What I am trying to do is to introduce a bill that will enable clinicians to look at a wider evidence base in order to get those medicines licensed.”

Despite the cross-party support, with MPs from various parties detailing the difficulties their constituents had faced, the PMB was talked out by some Conservative MPs, notably Katherine Fletcher, Sally Ann Hart and Dr Mullan, none of whom had been MPs when the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 bill was passed. Some of the objections raised appeared to be objections to the earlier bill rather than addressing the one being debated. 

For instance, Mrs Fletcher said, “There has not been enough research to understand formally, in the gold standard of a double-blind trial, whether these cannabis medicines do work.”

Mrs Hart said, “No matter how much we all want to see a change made, we are all aware that unfortunately there are people out there who would use medical cannabis as an excuse for recreational drug use. We have to avoid that at all costs.”

Mr Smith responded, “the hon. lady said that we all know that people would try to use medical cannabis as recreational cannabis. I have to ask her where the evidence is for that. The fact is that these medicines are not the same as recreational cannabis. Look at Epidiolex or Bedrolite: people do not use them to get high. We are talking about completely different things. I really think that that is a red herring that the hon. lady should not have thrown in.”

Dr Mullan’s opinion was that the necessary health systems are already in place and don’t need to be altered (again, characterising the PMB as a Labour/opposition initiative): “I just reiterate that the things that members on the opposition benches have been asking for have been happening. It may be at a rate that frustrates them, but I share that frustration, as do many others, and it goes across lots of different clinical treatments.”

Crispin Blunt MP (Conservative) spoke in support of the Medical Cannabis (Access) Bill which had cross-party support; Mr Blunt has been co-chair with Mr Smith of the APPG for drug policy reform since 2011, and is chair of the new APPG for CBD products

Another doctor, Rosena Allin-Khan MP (Labour) expressed her concern about the nature of some of the objections being made in the debate: “The objectives of this bill, for me, are clear and simple, but I fear, listening to some of the contributions today, it has been misunderstood.”

Dr Allin-Khan outlined the injustice she perceived in the present situation: “Families being forced to pay for treatment from private providers creates an unjust two-tier health system. A founding principle of our health service is that we do not believe that people’s access to treatment and services should be based on their ability to pay—it is as simple as that. The barriers in accessing medicinal cannabis are causing exactly that situation. We would not tolerate that for any other medication, so we should not tolerate it here. The government must speed up and improve the availability of medical cannabis on the NHS and guarantee that patients across the country can access those products where appropriate.”

She also raised concerns about desperate families turning to poor substitutes if they cannot access NHS-prescribed CBMP: “I understand the importance of robust, evidence-based medicine, but I can also tell hon. members that people searching in a very desperate way for things that will improve the quality of their life, or even keep their children alive, might also go to places where absolutely no thought is given to the purity of a drug. They may seek alternatives that are increasingly more dangerous for their children. It is important to recognise that.”

During the debate, Andy McDonald MP (Labour) recalled Sajid Javid’s role in changing the law in 2018: “The new Secretary of State for Health and Social Care was pivotal in the change in the law when he was Home Secretary. I urge him, the minister and the department to give effect to that change and remove all barriers to getting medical cannabis to those patients.”

Similarly, Tonia Antoniazzi MP (Labour) said, “I really want to know what [the government] are going to do. This has been collaborative, cross-party work, and I have had good conversations with the Secretary of State this week and with the minister a week ago. The solution that has been put forward to me is quite interesting. They say, ‘Oh, well you could find one of these drug companies that you know and work with, and maybe they could put an observational trial together, and we could have the conversations with the necessary bodies, we could work on this and then it could move forward’—this is the point I was coming to—‘in another two to three years’. After four and a half years, we are already in a situation where some of these children are now adults, so we are going to be looking at another, completely different situation. This situation has to change.”

“I beg right hon. and hon. members not to talk this bill out today, as they have been instructed to do”

Andy McDonald MP

As well as all the accounts of constituents’ difficult experiences, Mr McDonald spoke of his own, declaring an interest, and so joining the ‘dots’ of parent and politician in one person. His moving speech was broadcast on BBC Radio 4’s Today in Parliament, and was one of those rare occasions where the profundity of an individual politician’s experience resonates around the House and beyond.

“I have a 26-year-old son with epilepsy and severe developmental delay and special needs as a consequence,” said Mr McDonald.” I would like to explore further whether medical cannabis might be of assistance to him, but hitherto, the system is as resistant as the condition itself.

“He had two older brothers, one of whom we lost when he was just 16 years old, 15 years ago—colleagues will have heard me mention him before. I do not know whether medical cannabis would have helped him, had we even known about it then, but I will do everything I can to assist families right now in their determination to get the medication that their children need.

“We were confronted with our beloved Rory locked in status. I recall so vividly calling the ambulance and having him whisked off to hospital, where the consultant told us we better call a priest, and then all of us, my wife Sally, my son Paddy and my daughter Rosie, holding Rory as he died. I never want to have any of those families suffer such an outcome. I bitterly regret that I have not shown the courage and determination of people such as Hannah Deacon in securing that medication for her child. How I wish I had been as wise as she. I beg right hon. and hon. members not to talk this bill out today, as they have been instructed to do, but to do the right thing and help to take this small step today, to remove one of the barriers placed in the way of people so desperately in need of these treatments and to give them access to this life-changing and indeed life-saving treatment.”

His pleas weren’t heeded, and the bill was talked out. 

I can’t help wondering, if cabbage rather than cannabis were the source of a plant-based medicine which radically reduced epileptic seizures, and which patients said gave them radical relief from other debilitating conditions, would it be embraced more wholeheartedly, and would the understandable administrative difficulties in prescribing it be tackled with more urgency? Are decision-makers held back by attitudes (their own or those of voters) which conflate cannabis and criminality? Cannabis is just a plant; any associated crime is the action of humans. Government and wider society manage to distinguish between legal and illegal uses of other plant-based drugs, most notably morphine and heroin. Why is it so difficult to view cannabis dispassionately?

Green shoots are remarkably resilient. Snowdrops and daffodils aren’t damaged by frost and snow, but just keep pushing on upwards. This grouping of politicians, campaigning organisations, patients, families, medics and scientists look determined to do the same.

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