Medical Cannabis (Access) Bill
Debate between Jeff Smith and Baroness Keeley
Jeff Smith
My hon. Friend makes a really important point. They have nothing to lose. The problem is that we have to balance benefit and risk and, for this cohort of children and lots of medical cannabis patients across the country, the benefit is far greater than the risk. That is the frustration, and the problem with access to medicine is that lots of patients with different conditions would benefit massively and, if we are being honest, I think we all know that the risk is pretty low.
I want to contrast Alfie’s case with the story of another mum and her son who does not have a prescription for his epilepsy. This young man is now 18; he started having seizures in 2016 when he was 12—does that add up? I thought I had got my dates wrong, but that is correct. In 2017, after trying treatment on seven different anti-epileptic drugs and 16 different combinations, he was diagnosed with drug-resistant epilepsy. A cocktail of pharmaceuticals left him with impaired cognition, memory loss and an inability to process new information. He was still having regular seizures and was often in and out of hospital, requiring emergency treatment for status epilepticus: a seizure or a series of seizures that last for more than five minutes and can be fatal.
In 2018, desperately looking for anything that might help, the boy’s mum took him to the Netherlands, where a hospital agreed to treat him with Bedrolite. The doctors there eventually concluded that conventional anti-epileptic drugs were making his seizures worse and weaned him off them gradually, resulting in his cognition and memory improving. When they tried to wean him off the cannabis-based medicine, Bedrolite, his symptoms rapidly deteriorated and he almost died. He was put back on an increased amount of Bedrolite in combination with two newer anti-epileptics, and he has now been completely seizure-free for more than a year.
That young man’s health depends on Bedrolite, which is a fraction of the cost of the emergency hospital treatment that he used to require. His Dutch neurologist said that adults with uncontrolled epilepsy as severe as his would likely have to live in an institution for their whole lives. However, the young man writes:
“I’m now able to think about my future for the first time in years and want to go to art school. We are desperate to come home but I’m really afraid of the seizures starting again if I’m not allowed a prescription for Bedrolite. My mum and I are so scared of more seizures again and that I won’t be allowed to carrying on living a healthy life like I can now.”
As a result of the barriers to access in the UK, the mother and son are effectively living in medical cannabis exile in the Netherlands. That is not right.
The third example is not a child with epilepsy. Lucy Stafford has a condition called Ehlers-Danlos syndrome. She had been almost permanently in hospital, having suffered from joint dislocations after her first surgery when she was 10 and another 19 operations throughout her teenage years. Her condition deteriorated. She became bed-bound at 17. She said:
“I was kept alive by intravenous feeding tubes and taking fentanyl to ease the debilitating pain of dislocating multiple joints a day”.
As many people know, fentanyl is an opioid that has been responsible for a very large number of overdose deaths in the USA. We do not really want people to take it if there is an alternative. The alternative to lots of opioid treatments is, in my view, medical cannabis.
Lucy faced extreme pain from a permanently dislocated jaw, and when she was in hospital, she faced potential death from sepsis. Lucy’s pain specialist suggested medical cannabis as a last resort. The prescription was turned down for NHS funding, with a letter saying that cannabis was unlikely to work and that there was a one in four chance that she would end up with psychosis, so Lucy and her mother went to Amsterdam and sourced medical cannabis. Eventually, her jaw began to unlock. She was able to reduce her opiates and other pharmaceutical medications. She has since become able to walk unaided. She is now back in the UK and she started a degree in neuroscience at the University of Sussex this September.
Lucy’s private prescription for cannabis in the UK initially cost £1,450 a month. She is now enrolled in a medical cannabis trial called Project Twenty21 run by an organisation called Drug Science. I draw attention to my entry in the Register of Members’ Financial Interests: I am an unpaid trustee of Drug Science, which does fantastic work in its research into drugs. Project Twenty21 facilitates access to medical cannabis effectively at cost price, once patients have been seen and diagnosed by specialists, so Lucy’s medicine now costs her about £450 a month. As an example of the potential saving to the NHS, when Lucy was on a feeding tube her medication alone cost more than £250 a day, and the hospital room cost very much more. Overall, the estimated cost to the NHS is probably more than £100,000 a year. Despite the huge savings, her local hospital trust refuses to allow her physician to prescribe medical cannabis for her on the grounds of
“lack of evidence of efficacy”.
That is the key problem in the UK: the difficulty of getting through the barriers in the system. Lucy’s life has clearly been absolutely transformed by medical cannabis, but because of the systemic barriers, she has not been able to access it through the NHS. That is not logical in any way. It would make much more sense for the hospital trust to support her.
We know that cannabis-based medical products work for many patients. We know that they are legal. We know that they are effective. They are being privately prescribed by some specialists in the UK, but patients cannot get them on the NHS, so ordinary families are sometimes paying a fortune for their treatment. Some are having to go to Holland to get their medication.
One thing really demonstrates the absurdity of the situation. Because of import-export problems since Brexit, it has now become even more difficult to import Bedrocan products, which are the medicines produced in Holland, so the Government have done a deal that has facilitated the imports and licensed production facilities in the UK. Virtually nobody can get medical cannabis on prescription on the NHS, but the Government accept its efficacy enough to have done a deal with the Dutch Government to ensure a supply of Bedrocan for UK families and have even gone to lengths to start having it produced in the UK. It does not make any sense at all—it cannot be right.
Why are we in a situation where patients cannot get these NHS prescriptions? The general consensus is that it stems from a nervousness regarding the evidence and the guidance about these medicines, and a consequent reluctance of many clinicians to prescribe on the NHS. There are a very limited number who will prescribe privately: in the case of childhood epilepsy, there have been only three specialists willing to prescribe. One is now retired, and the others are not able to take on any more patients, so there is another blockage. There is also a reluctance among clinical commissioning groups and trusts to fund prescriptions; Lucy’s hospital trust is a good example.
At the moment, only a small number of cannabis-based medicines are licensed by the Medicines and Healthcare Products Regulatory Agency for the small number of specific conditions that I outlined earlier, so the cannabis medicines that are generally prescribed in the UK are unlicensed and prescribed as “specials”. Clinicians, even specialists, are sometimes reluctant to prescribe those unlicensed products. In the narrow pool of those who can prescribe, there is often a reluctance to prescribe unlicensed cannabis-based medicines, owing to a lack of knowledge and training; confusion over conflicting guidance from Government bodies such as the National Institute for Health and Care Excellence, and from the NHS and professional bodies such as the British Paediatric Neurology Association; a lack of confidence in the evidence base because of a lack of randomised controlled data; and ultimately a fear of repercussions because of the personal liability when prescribing an unlicensed medicine.
Currently, only specialist doctors on the General Medical Council specialist register are allowed to initiate a prescription, although GPs can carry it on under the guidance of a specialist. The specialists who do want to prescribe usually face barriers from their NHS trust or CCG, which normally declines to fund the prescriptions. If an NHS prescription is to be made, it has to go for approval to what is called a higher authority, usually a CCG or trust, which is usually reluctant to fund because of the problem relating to evidence and contradictory guidance. I should add that that process applies to no medicines other than medical cannabis.
For some time, campaigners have pressed the NHS and the Department of Health and Social Care to explain the process and the pathway that can deliver an NHS prescription in cases in which an NHS specialist wants to prescribe cannabis-based medical products. Perhaps the Minister could enlighten us, because although the Government committed themselves to doing that in 2019, it has not happened. The only solution suggested so far is an individual funding request, but we know that families who have tried to take that route have been rejected and told that the patient has not demonstrated clinical exceptionality. It is very difficult to obtain funds in that way. If the impact that medical cannabis has on that cohort of epileptic children with extremely rare and severe diseases is not deemed clinically exceptional, I would ask what is.
There are two ways in which we need to make progress. First, we need clinicians to be confident in the specials that they are able to prescribe, and we need NHS bodies to be confident enough to fund them. Secondly, we need more safe, effective cannabis-based medicines to be licensed. That is a key issue, because although there is a wide body of evidence for the efficacy and safety of cannabis medicines, it is largely patient-reported or observational and evaluative. The UK’s medical regulatory bodies generally only license medicines on the basis of randomised control trial data. I do not think anyone would deny that double-blind placebo randomised control trial data are the gold standard for medical trials aiming to demonstrate the safety and efficacy of medicines, but they are not the only way of demonstrating those qualities, and they are very difficult to carry out on whole-extract plant cannabis products.
Cannabis-based medicines are not made up of a single compound, and patients often use bespoke mixtures to treat their conditions most effectively. Let me quote Professor Mike Barnes, as my hon. Friend the Member for Middlesbrough (Andy McDonald) did earlier. He has said:
“While there are some RCTs”
—randomised control trials—
“for CBMPs”
—cannabis-based medical products—they are generally for isolates of those products, and
“the cannabis plant doesn’t lend itself to being studied this way as it’s a botanical product with several different components.”
Many experts, including Professor Barnes, would argue that we need to look at a different evidence base to demonstrate the safety and efficacy of whole-plant extract cannabis-based medicines.
Even Sir Michael Rawlins, the previous head of the MHRA and NICE, pointed out in 2008 that RCTs were not the only way of obtaining getting evidence. He said:
“Randomised controlled trials… regarded at the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of ‘hierarchies’ of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base.”
There are many other sources of evidence that could equally inform medical practice. They could include patient reported outcome measures—PROM—trials, real-world evidence effectiveness trials, pharmacoepidemiology —I can never get that word right—which means looking at real-world evidence among a large group of patients, observational research, and n=l trials.
Barbara Keeley (Worsley and Eccles South) (Lab)
I have been working with a constituent whose son is in this position. Does my hon. Friend agree that the side-effects of the synthetic elements of the products being used are a serious issue? It is all very well to say that trials and evidence are needed, but people are using other products that they are getting privately, and my constituent is desperately worried that the side-effects could proliferate over time when a child has been pushed into taking them.
Jeff Smith
That is an important point. No one is claiming that every product is absolutely safe, and products often have side-effects, as Alfie’s case demonstrated. He had been pumped full of steroids which affected him badly and would eventually have killed him. That was a medication that was recommended until he started taking medical cannabis.
There is lots of evidence from around the world. Cannabis-based medicines have been legal in Canada and some US states for some time, and there are tens of thousands of individual patient reports on the therapeutic value of cannabis-based medicines in the Canadian and, in particular, Minnesotan databases. They do not equate to the so-called gold standard double-blind randomised control trial level of proof, but they are highly suggestive of a pattern of evidence that should be taken seriously. Another issue is that many people would argue that it is not ethical to insist on RCTs for the cohort of children with epilepsy, as they would have to be taken off the medicine that is keeping them well, and keeping them alive in some cases, to put them on a placebo. Some people would question that process.
In 2019 the Health and Social Care Committee looked at the barriers to access for cannabis-based products, and the Government produced a response to its report in which they made reference to the need for observational trials to help the patient cohort of children with severe epilepsy. Even the Government argued that we should be considering other forms of evidence, and I know from my interaction with the MHRA that it is considering other forms of rigorous, well-researched evidence. Unfortunately, the Government’s view seems to have changed. I have spoken to Ministers and officials again, and they seem to be wedded to the idea that RCTs are the only way forward.
My Bill would set up a commission to propose a framework for the assessment of cannabis-based medicines and their suitability for prescription in England, to sit alongside the existing MHRA processes for conventional pharmaceutical drugs. The commission would help rigorously to assess all the existing evidence base and to consolidate all the available evidence, which could give those who are eligible to prescribe more confidence in the evidence for prescribing this particular unlicensed medicine.
I hope that the commission’s work will result in a more suitable framework for the assessment of the efficacy and safety of cannabis-based medicines, which I hope would result in more cannabis-based medicines, including whole-plant medicines, becoming licensed. That would go a long way towards addressing the problem. It would improve the likelihood of prescription on the NHS for both severe and common conditions. The commission would also be tasked with identifying any other barriers that could be overcome to improve access. That might result in the adoption of short-term solutions that I will touch on shortly.