Baroness Keeley
Main Page: Baroness Keeley (Labour - Life peer)(2 years, 11 months ago)
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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.
Barbara Keeley (Worsley and Eccles South) (Lab)
I thank my hon. Friend the Member for Manchester, Withington (Jeff Smith) for introducing this important Bill that could improve the lives of so many people. As we have heard, it could particularly help families with children affected by serve treatment-resistant epilepsy, for whom cannabis-based products may be the only treatment that works. I pay tribute to my hon. Friend the Member for Middlesbrough (Andy McDonald) for his powerful appeal on behalf of the Bill.
My constituent Zoe Kirkman contacted me several years ago when she was seeking treatment for her son Riley, who experienced severe seizures up to 30 times a day that were very distressing for both him and the rest of his family. Ms Kirkman told me she was worried that he could die at any moment as a result of a seizure. These are the fears of parents and that is what drives them.
Riley’s condition has led to his missing a lot of education and being out of school a lot. As she could not access cannabis-based treatment for Riley on the NHS, Zoe Kirkman was forced to purchase THC and CBD products privately. As we have heard, many families are in a similar position, left with no choice but to pay hundreds of pounds a month—in some cases thousands—for private prescriptions. THC products work better for Riley, but Zoe Kirkman told me that there was little support alongside the prescriptions when they were purchased privately. The fact that parents are pushed into private prescriptions with little support must have some weight with us.
Thankfully, the cannabis-based treatments that his mother bought have reduced Riley’s seizures significantly and allowed him to stop taking a lot of his medications. However, he is still out of school because his school cannot include the cannabis-based treatment in his rescue package, as it is not prescribed on the NHS. For the same reason, Riley cannot access respite care, which would help him, at St Francis children’s hospice. Will the Minister say why schools and respite-care facilities such as hospices cannot be allowed to administer the oils that make such a difference to children such as Riley? Zoe Kirkman tells me that if Riley has a seizure because of a gap in the treatment, it can take weeks for his condition to settle down again.
In July 2018, I wrote to the then Home Secretary to raise Riley’s case. I received a belated response from a Home Office Minister in January 2019—more than six months after my initial letter—saying that following the changes to the law in November 2018, he hoped Riley would be receiving the treatment he needed. Of course, he is not receiving that treatment. The campaign group End Our Pain estimated that, a full three years on from the rescheduling of cannabis-based products to schedule 2 to the Misuse of Drugs Regulations 2001, just three children living with severe epilepsy have received an NHS prescription. As we know, two of them were at the centre of the 2018 campaigns. We have heard that a number of times in this debate and it is right that we focus on the fact that there have been just three prescriptions, and ask why.
When the Health Committee ran its inquiry on medical cannabis in March 2019, it heard from Peter Carroll, the campaign director at End Our Pain—we heard about him in earlier speeches—who said:
“What has happened is that hopes have been correctly raised, because this offers a lot of hope and benefit to a lot of people, but we have now moved across to implementation and the honest reality is that it is a disaster…The families…should be getting prescriptions…and watching their children…hopefully…improving day after day.”
After the Government raised hopes with the change in the law, it is a great pity that they have not increased access to medical cannabis for those who need it in line with the findings of the review that they commissioned in 2018. I hope that the Minister will explain why.
While I accept that we still need more research and studies into the effectiveness of cannabis-based products for treatment-resistant epilepsy in children, the Bill would offer important measures to increase the number of doctors who could prescribe such products and widen access to them through its proposed commission.
I asked Zoe Kirkman what she hoped for. She told me it was a purer form of the medication, because the products available to purchase contain a lot of synthetic ingredients and she worries that they could have long-term side effects for Riley. I hope that, through the Bill, Zoe Kirkman and Riley, and many families like them, will finally be able to access the treatment they need through the national health service.
The Bill contains a proportionate set of measures, with a commission to propose an assessment framework for cannabis-based medicines and their suitability for prescription and to make recommendations of measures to overcome the barriers that we have heard about in CCGs and other NHS structures to accessing cannabis from the NHS for medical reasons.
We have had a lengthy debate about different forms of trials. The commission could consider evidence from observational studies and from other countries as well as conventional control trials. My hon. Friend the Member for Manchester, Withington made an important point about evidence that could be weighed from EU countries—it is time that we started to think about that. It could also consider the important register of GPs who may prescribe cannabis-based medicines and permit them to do so. That would help to avoid the side effects of the cannabis-based products that Zoe Kirkman is currently forced to buy as the only option available. Most importantly, Riley would be able to attend school and have respite care when he needs it.
Let us end the years of pain. As my hon. Friend said at the end of his excellent speech, if not this Bill, what else?
Sally-Ann Hart
Yes, I absolutely agree with what my hon. Friend says, and I will be coming to the call for evidence a little bit later in my speech—
Sally-Ann Hart
Can I just finish one sentence?
I will be coming back to the need for more evidence and for manufacturing businesses to come forward, because there is huge potential. There is huge potential for manufacturing businesses and pharmaceutical companies to come forward with evidence to expand the amount of cannabis-based products that will and should be available on prescription from the NHS, so that the mothers who are trying their best for their young people and children are not having to pay a fortune to get this medicine privately.
Barbara Keeley
It is obvious to see what is going on here—Government Members are trying to talk out the Bill—but an argument was made in the previous intervention that we needed more evidence. This Bill would provide that, because it would bring forward a commission that would consolidate evidence and give a suitable framework for assessing cannabis products. That is what it is all about. Government Members worried about evidence should vote for the Bill.
Sally-Ann Hart
I will give way in a minute.
We already have legislation and pathways in place. The Government have made big inroads on facilitating cannabis-based products for NHS prescription. We are on the path. Do you think primary legislation will force the hand of pharmaceutical companies or manufacturing businesses to bring forward products for clinical trials?
Sally-Ann Hart
Thank you, Madam Deputy Speaker. I understand that we have to use the right terminology because it depersonalises the debate, which is most important.
I am not sure whether I answered the intervention by the hon. Member for Gower (Tonia Antoniazzi), but I had better move on.
Barbara Keeley
The hon. Lady is talking about needing a debate on the Bill, but that debate could happen in Committee. All the points that Conservative Members are making—excruciatingly slowly to spin out the time and talk out the Bill—could happen there. The way that the legislative process works is that we get to Second Reading and vote for the Bill, then the details that Conservative Members are so keen to bring up now can be thrashed out in Committee. Let us make some progress.
Sally-Ann Hart
I thank the hon. Lady for her intervention, but if we only had debate in Committee, many hon. Members would not get to put forward their view, because they might not be on that Committee.
Dr Mullan
I will go on to talk about what I think you need to do—when I say “you”, of course, I mean the clinical community rather than the hon. Member—to advance these issues. I am afraid that very difficult work needs to be done across many parts of the clinical community, involving engagement with individual clinicians. The last thing we should be doing is creating a new mechanism for the appraisal of a clinical treatment in the NHS. I cannot support that when there are already well-established, well-developed mechanisms for the purpose which do not rely on any particular randomised control trial, for example. We know that, because several treatments have been approved, although it has been argued that cannabis-based treatments cannot be approved in the existing frameworks.
Barbara Keeley
Both the hon. Gentleman and one of his hon. Friends have questioned the use of primary legislation such as this wonderful Bill to advance this cause and remove these barriers. His hon. Friends have done the same on a number of occasions when private Members’ Bills have come before the House. What about the Autism Act 2009? What about the Down Syndrome Bill, which we discussed last week? When an issue—such as a medical condition—is not receiving the attention, or the appropriate treatment, that it should be receiving from the NHS, Members present Bills to deal with that. Such Bills are generally applauded here, but somehow this particular instance of using primary legislation to remove these barriers for this group of people—
Barbara Keeley
The hon. Gentleman sits there shaking his head, which he has been doing for about an hour, but it is not reasonable to pick this out as a separate issue.