The speech made by Kieran Mullan, the Conservative MP for Crewe and Nantwich, in the House of Commons on 10 December 2021.
I welcome the opportunity to speak in this debate. I congratulate the hon. Member for Manchester, Withington (Jeff Smith) on introducing the Bill and highlighting the issue. I understand that he is trying to improve the situation for patients who are struggling, and I accept that he has the best intentions in that regard.
At the outset, I think we have to unpick some of the debate so far. We are talking about two different things, potentially: unlicensed and licensed treatments. Some of the criticisms that have been raised about lack of evidence are very valid in relation to unlicensed treatments, but not so valid in relation to licensed treatments; that is an issue about how we spread best practice. What we are talking about today affects a lot of the NHS and a lot of treatments in many different ways: how we test and evaluate treatments, the accountability of our doctors and other healthcare professionals, and how we spread learning and best practice in the NHS.
We have come an incredibly long way with testing and evaluating treatments in the NHS. I will try to give some of the history and the context of the challenge of knowing what good treatment is, because it is an enormous challenge. If people understood the history and how badly we have got it wrong on so many occasions, they might better understand why healthcare professionals can often be reluctant when it comes to unlicensed treatments.
The starting point is the time when medicine was practised almost entirely without evidence. It was practised for a very long time without what we would now consider evidence. Clinical medicine has evolved organically over hundreds of years, if not thousands, from a starting point at which even the concept of evidence-based medicine was alien. In fact, there were occasions when individuals who sought to advance the cause of understanding the body and disease were castigated for challenging established understanding, even in relation to the most basic things.
An old example that illustrates how fundamental the challenge of understanding good practice can be relates to handwashing. We all now take handwashing for granted as something that we should all do and that helps to keep us safe, particularly in relation to a pandemic, but that is largely down to the efforts of one man: Ignaz Semmelweis, a German-Hungarian physician and scientist born in Hungary in 1818. He died in an asylum in 1865 having suffered a nervous breakdown, ostracised by the medical establishment that rejected his theories, which we now know to be true.
Semmelweis looked after women giving birth at a Viennese hospital. He worked in two different clinics; one had a maternal mortality rate of about 10% because of the infections that women would get after giving birth, while the other had a maternal mortality rate of about 4%. The difference was so stark that women begged to be admitted to the second clinic because it was common knowledge that they were much more likely to die in the first.
Semmelweis noticed that difference and set out to understand it. He studied every detail of what was happening in each clinic, eliminating all possible differences, and discovered that the only major difference was the people working there. The first clinic taught medical students; the second did not. He combined that knowledge with the incidental finding that a friend of his who had pricked himself with a scalpel when performing an autopsy had become sick and died, in the same way as the ladies in the first clinic, of a general unwellness—germs were not even understood at that point.
Semmelweis theorised that the connection must be something to do with contact with bodies among people at the clinic who were looking after the women giving birth. He instigated what we now take as common sense: handwashing with a chemical for anybody who had had any contact with those bodies and who went on to look after the women. When he instituted that policy, the maternal mortality rate in the clinic fell to exactly the same rate as the other’s.
That theory is a landmark in our understanding of clinical medicine, but at the time it was considered extreme and Semmelweis was widely mocked. He was eventually dismissed from the hospital for political reasons, harassed by the local medical community and forced into an asylum; he ended up dying in terrible circumstances. That just goes to show how fundamental it is to doctors that we recognise that at various times medicine has got it very badly wrong in all directions. That guides a lot of what we do when we decide what treatments to give.
Sometimes our beliefs about treatment are based on an incorrect understanding of the nature of disease, false assumptions about how the body works or misconceptions about cause and effect. If people get better after treatment, we very often assume that the treatment helped, when often it was just incidental. We now know about the placebo effect, an incredibly powerful effect that generates improvements in patients without the benefit of any evidence whatever. From 1898 to 1913, a heroin-laced aspirin was available for the treatment of sore throats, coughs and colds, with a particular focus on it as a treatment for children; it was only in 1924 that heroin was banned completely as a treatment.
We still have a long way to go. Some research suggests that up to half the treatments we use even now lack what we might consider a full and reliable evidence base. Importantly for this debate, we can be badly wrong not just in identifying an effective treatment, but in understanding its side effects in the longer term. I have listened carefully to the descriptions of benefits for individual patients and I do not deny in any way, shape or form that they are benefiting, but when we aggregate that across the whole population, we can discover side effects, particularly in the long term, that we are simply not aware of when considering the benefit for an individual patient.
There was some criticism of my hon. Friend the Member for South Ribble (Katherine Fletcher) for raising this example, but I had planned to raise it, too. People will have heard about the thalidomide scandal. That is important not as a comparison with a particular side effect, but in understanding how we get things wrong with medicine. Thalidomide was licensed in July 1956 for over-the-counter sale. No doctor’s prescription was even required in Germany. By the mid-1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries and, by 1958, that included the UK. A UK Government warning was not issued until May 1962 and, in the intervening period, the drug was responsible for a wide range of birth defects in children who would otherwise have been born healthy.
Fen-Phen was a weight-loss drug used in the 1990s. It is estimated that as many as 6.5 million people took it. People taking it experienced heart disease, lung and pulmonary problems, and millions of pounds in compensation was paid out to people who took it after it was withdrawn.
Vioxx was taken off the market in 2004 after having been available for five years. That is considered to be one of the largest drug recalls in history. Vioxx was given to more than 20 million people as a painkiller for arthritis, but was later found to be responsible for an increased risk of heart attack and stroke. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking this drug in the US alone. One study that I reviewed in anticipation of this debate found that 462 medicinal products were withdrawn from the market between 1953 and 2013 alone. This provides an important context for our discussion in terms of medicinal safety.
Modern clinical training teaches us how easily we can get our understanding wrong, how it can change and how difficult it can be to really understand the short and long-term benefits and harms of a medicinal treatment. We have a much more sceptical, vigilant workforce in healthcare as a result, and we must not be quick to rush to judgment when there is uncertainty about a particular treatment. We have come a long way with bodies such as the MHRA, NICE and others that attempt to support clinicians in making evidence-based decisions, because we realise that leaving it to the individual clinician is not necessarily helpful.
Do I understand the hon. Member well in thinking that he is saying that medical scientists do not know anything? We have allowed these children to have the medicinal cannabis. Is he saying that the scientists are wrong?
I encourage the hon. Lady to listen carefully to what I am saying. I said at the start of the debate that, absolutely, there are very good reasons for individual patients to receive this treatment. I have acknowledged that there are licensed treatments based on evidence, so I think she is kind of misrepresenting what I said. I said clearly that I am giving context to the—
Madam Deputy Speaker (Dame Eleanor Laing)
Order. I am sure that the hon. Member for Gower (Tonia Antoniazzi) was not misrepresenting what the hon. Member for Crewe and Nantwich (Dr Mullan) said. She is doing whatever he is suggesting that she is doing, but it will not be misrepresenting, because that would not be honourable.
Perhaps the hon. Lady is inadvertently giving an incorrect impression of what I said. I made it very clear that this is the context for how clinicians behave in our NHS.
Far from doing what has just been accused of you, I felt as though you are giving a—[Interruption.] The hon. Gentleman is giving a cautionary tale and providing context for this debate, and that is very important for this discussion.
I thank my hon. Friend.
I thank the hon. Gentleman for his generosity in giving way again. This debate has been had in the House for many years. We have spoken about it a lot. I would like to extend an offer to him and other hon. Members to join the all-party group on access to medical cannabis under prescription and to educate themselves.
With the greatest possible respect, I do feel that I understand the challenges that the hon. Lady is talking about. I will go on to answer her question about the fact that we have talked about it for a long time, so how do we move it forward? As I will explain, unfortunately, that applies to a very wide range of treatments and clinical practices in the NHS and across the world. This is about the appropriateness of picking out one specific area of clinical practice and using primary legislation as a way to overcome one particular problem. That is my concern.
The hon. Gentleman is failing to grasp that we have done it. The change has been made. What I am hearing time and again from Government Members is them rewinding and revisiting the process. The medications we are talking about are authorised and have been prescribed. We do not need to go through this exercise again—we have done that, and we want to move on.
I have explained that there are two challenges here. There are licensed, accepted treatments that are not being used, and there are very many examples across the NHS and healthcare globally of accepted, best practice, effective treatments that are not necessarily used as widely as they should be. We should not be picking out a particular treatment and using primary legislation as a mechanism to overcome that in one example; we should be working across the system and doing the hard work that has to be done to change clinical practices, as I will go on to explain.
In terms of reopening the debate, as I have explained, there is still a debate to be had about unlicensed treatments where there is not an evidence base for their use. We are talking about two things today, and I wish hon. Members would be more careful in understanding the distinction between the two and not—[Interruption.] That is the argument I have made. I will carry on and make progress on the other issues I wish to discuss.
I think there has been an accusation from the Opposition Benches that my hon. Friend does not seem to be educated in this particular area. Can he outline for the benefit of the House how much he understands medicine?
I thank my hon. Friend. When it comes to the issues I want to come on to talk about, it is not so much my practice as a doctor, but the fact that several years before becoming an MP I worked for the national clinical audit commission. The whole task of that organisation and very many other organisations in the NHS is to attempt to get clinical practice to change. There can be evidence and acceptance of what is best, and it does not happen, for very many reasons. That is the point I am trying to get across today.
I understand the focus on this particular treatment and I do not in any way underestimate the impact on patients but, as a constituency MP, I have several other examples of other treatments and other things people want to have on the NHS that they are not able to access. We have to think about how we tackle that in the broader sense, and I do not believe that picking out a particular treatment and putting it into primary legislation is the way to do that.
In an effort to draw some unanimity across this House, we are all keen to move things forward. We do not want to wind the clock back; we want more treatments through the licensing process. Does my hon. Friend agree that what he is calling for is a cautious, evidence-based way of doing that? We are not winding the clock back—[Interruption.] The shadow Minister intervenes from a sedentary position, but it was she who pointed out that the legislation is already there and that this private Member’s Bill does not seek to frustrate that. I think we are all pushing in the same direction and I would like to draw us to push further.
The point to draw from my hon. Friend’s intervention is that I have been working in this field for some time and I cannot think of any other example where we have decided to set aside all the ordinary processes that have been developed over many years, with great thought and attention to ensuring they are equitable in terms of resources, the NHS’s time and NHS researchers’ time, and come up with a whole separate process for determining the evidence on a particular treatment. That has never happened before that I am aware of.
I am happy to take an intervention from anyone on the Opposition side who can give me an example of when we have ever done that before, putting in place and encouraging the use of a particular treatment. I notice they do not—
Jeff Smith rose—
Do, do intervene.
The hon. Gentleman is right, and I respect his view. He is very knowledgeable in these areas. The point, as I tried to outline earlier, is that there are very many experts who think the process we have at the moment is not appropriate for the cannabis plant and the full plant cannabis extract. All I am asking is for the wider evidence base to be looked at. That is also what the NHS asked for in 2019 and what Sir Michael Rawlins said we should be looking at. There are a lot of people who think that randomised controlled trials are not necessarily the right way forward in this particular instance. All I am asking is for the evidence to be looked at.
All I would say is that those discussions need to be had with NICE, the NIHR and the Department of Health and Social Care and many other people, but to use primary legislation is not the appropriate way to do it, I am afraid.
Without doubt, no one in the House wants anyone to suffer unnecessarily. However, most of us understand, as I am sure the hon. Member does, that in this case a randomised control trial would be immoral. The recipients of these medications are in such dire need that to find a group of children in as dire need and deliberately withhold treatment from them would be immoral. I respect him for his clinical and professional practice and as a Member of Parliament, but what is his alternative? The Bill, which has already gone through several stages with cross-party agreement and understanding, seeks to take this forward in unusual circumstances, where an RCT would be immoral.
As you know, I respect your experience—
Madam Deputy Speaker (Dame Eleanor Laing)
I respect the experience that the hon. Member brings to her role. At no point have I said that the only way in which we can proceed is through RCTs. Earlier in the debate, when Opposition Members started talking in broad terms about observational studies and, to my mind, they were unfortunately disparaging RCTs, my comments were about being cautious. RCTs are incredibly important—they are fundamental to the vast majority of clinical medicine. I agree that other types of studies will be needed in some circumstances, but people need to make those arguments to the National Institute of Health Research. It is not for us as parliamentarians to override well-established processes designed to ensure that things are done in an appropriate, fair, thought-through and well-funded way.
The hon. Member is eloquent, but he is making a case for the commission. As the explanatory note says, the commission would be
“required to consider the role of evidence other than from conventional controlled trials, including from observational studies and other countries in which cannabis-based medicines are more widely available.”
So the net is wide. We are not pre-determining the evidence that would be considered. Opposition Members are saying that randomised control trials are not appropriate—we agreed on that; he has said that that is problematic—and there are other ways to look at this. We are not pre-determining it. We are saying that a commission of experts should do exactly that. Can he not see that he is speaking in favour of the Bill?
No. The point I am making is that nothing in the NIHR’s work says that it will only consider research and applications that are RCTs, and nothing prevents NICE from looking at any number of other methods of research. Opposition Members are saying that the Bill is the only way to get people to look at the evidence more broadly, but that is simply not true.
Briefly, I think I heard the hon. Member for Tooting (Dr Allin-Khan) talk about an RCT being immoral, implying that there is only one specific type of study design. She is talking about an RCT that would include forcing a placebo on children who are receiving medicine at the moment, but does my hon. Friend agree that RCTs can be designed in other ways and that we should not tar them all with one brush?
I agree. We have talked about observational studies and RCTs, and there are a number of different ways in which the evidence base can be developed.
Having a number of research degrees, I am very aware that there are many different types of trials and that a randomised control trial is not the panacea in all cases. That exactly speaks to the importance of the Bill, which considers a number of other options. It talks about looking at evidence from a widely cast net—it is in agreement with the hon. Member. If he does not agree with the Bill’s suggestions, which he is speaking to, what is his alternative?
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.
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—
Dr Mullan indicated dissent.
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.
There is a difference between presenting a Bill that seeks to establish frameworks and approaches that have had a wider application and seeking to use a Bill to advance a particular medical treatment. There is not another example of that in the House. The examples that the hon. Member has given did not seek to advance a particular medical treatment through primary legislation. I do not consider that acceptable.
This is a point that I hope to address in my own speech, should I have time to make it this afternoon. I know that many Members wish to contribute.
I spoke in the debate on the Down Syndrome Bill last week. Does my hon. Friend agree that the difference between that Bill—and the Autism Act—and this legislation is that whereas the Down Syndrome Bill was seeking to fill a gap, trying to bring different agencies together to create a common framework because there was obviously a deficiency and they were not working together, this Bill, as I understand it, seeks to duplicate the work of a body that already exists and is already functioning? In that sense, the two Bills are very different and cannot be compared.
I entirely agree. For example, if this legislation were seeking to reform or amend the general approach that we take to the appraisal of healthcare technology treatments in the NHS, I might have more sympathy with it, but it is not seeking to do that. Its promoter has picked out a particular line of medical treatment and sought to use primary legislation to drive it forward, and for the reasons I gave earlier relating to the history of deciding what treatments doctors should or should not be using, that is something about which I am extremely uncomfortable, although I am very sympathetic to the individual cases that Members have been raising.
In November 2019, NICE conducted a review of the international evidence available in respect of this important issue. The report that followed was essentially inconclusive, but it did consult widely and obtained a wide range of information on some of the issues that Members have rightly identified. If the commissioning proposal in the Bill went ahead, how would the relationship with NICE and its statutory responsibilities work in this situation?
As my hon. Friend says, this is creating complexities and competing relationships that need to be given considerably more thought, rather than our aiming to promote a particular treatment.
We have talked about the risks. I now want to describe some of the many ways in which healthcare practitioners are held to account for their decisions. This is particularly important in relation to the unlicensed use of a medicine. First there is the sense of personal, moral or social responsibility that we would hope anyone involved in healthcare feels. Even if we do not necessarily take the Hippocratic oath any more, we are signed up on the basis of the fundamental principle, “First, do no harm”. Understanding that can be complicated, as I have tried to explain in relation to side-effects, for example.
Secondly, we are accountable to our employer. For example, a person working in a hospital is not free to practise as they wish. Their employer will have reasonable expectations that they ensure that their practice is safe, evidence based and works in the best interests of their patients. Increasingly, employers will place a big emphasis on following best practice guidelines from royal colleges, the National Institute for Health and Care Excellence and others that restrict their practice in some regard.
There is nothing in this Bill that will substitute our view and our professional assessment for that home medical practitioner. I want to congratulate the Members on the Conservative Benches: the clock is running down to 2.30 and they have successfully talked out this Bill. May I just ask anybody on those Benches to volunteer some explanation that I can take back to my constituents who wanted to see us make progress today, and we have not. By the way, can they also think of something that I may be able to say to my wife?
I think the hon. Member will understand that legislative progress is not an exercise purely in discussion. We should not be putting forward legislation if Members on one side of the House do not feel that that legislation should be passing into law. I am very happy to say that, for the reasons that I have outlined and will continue to outline, I do not feel that this legislation is appropriate, and I do that and will still sleep soundly tonight. It does not mean that I do not understand the deep concern, the hurt, and the anguish that individual parents are feeling. As I have said, I have worked in this field for a long time. There are very many people who suffer hurt and anguish in relation to treatments. I can talk about my own personal experience. My mother was diagnosed and treated for cancer. There was a period of a couple of years where I had seen a treatment that I wanted her to be on because I felt that it would be effective. There was some evidence to suggest that it was effective. We had to wait a couple of years for the further studies to come out, recommending that particular treatment. I have a young boy in my constituency, or a neighbouring constituency, whose family has raised an enormous amount of money to go to another part of the world to try a treatment that we do not consider to be sufficiently evidence-based—
That is not this—
The Member shouts from a sedentary position, but I am afraid that we are talking about a relevant issue. Labour Members want unlicensed treatments to be brought forward. There is a mixture of unlicensed treatments and licensed treatments.
Members say that they do not want to achieve that, so why are they bringing forward this legislation? If they do not think that it will make a difference to the use of a treatment, why are they bringing this Bill before the House? They must think that it will have an impact.
I think the hon. Gentleman might have inadvertently misrepresented things. 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. That is what I am trying to do. I want to listen to the hon. Gentleman because he is very knowledgeable and I respect what he is saying. I think he is making an important speech. It is disappointing, however, that Members have spoken for so long that the Minister will not be able to speak. That is a bit of a poor show from the Government.
As I said, my view is that there is nothing at the moment in any of the legislation or roles of the bodies that we already have in place that restrict them from looking at any particular type of evidence. That is simply not true. They are allowed to look at whatever evidence they choose to look at. It is whether that evidence is there, is available to them and is sufficient.
I know that there has been a lot of talk in this debate about a campaign that has been going on for four years. My hon. Friend speaks with his medical experience, and many of us on these Benches do not. Does he agree that there has been a churn in the representation of this House over the past four years and there are new MPs who are coming to this debate afresh? This debate has been very useful in illuminating and educating those Members who are newer to the debate and that has been a very productive exercise. Does he further agree that, in spite of the understandable emotions that exist within this debate, the primary duty of Members of this House is to pass good legislation?
I completely agree. I would just add that processes are in place because we are at the greatest risk of making mistakes when we are faced with people in very desperate circumstances. The risk is greatest when a parent is extremely concerned for the welfare of their child, or when someone has a terminal illness. Those are the types of scenarios where people are most at risk of having the wrong treatment. I gave the example, which is incredibly important to remember in the wider discussion, of the MMR cases. Parents were advocating very, very strongly that that treatment had caused damage and distress to their children. Doctors were involved in amplifying and giving credibility to that circumstance. As a result, fewer people took their vaccines. I say this with all compassion to individual parents, but we have to retain a degree of objectivity, and I am afraid that parental passion is not a substitute for the systems we put in place.
We all know there are a huge amount of emotions around this argument. All of us, I think, across the House would like to see the situation move forward. The issue is that the proposed legislation will not move things forward. In fact, it has the potential to slow the whole process down. If I understand it correctly, a private Member’s Bill cannot bring forward any money resolutions. What we need here is money, and for CCG and NHS processes to be working properly. We do not need primary legislation to do exactly what hon. Members across the House want. We just need to get on with it via the NHS and CCGs.
My hon. Friend is correct to say that in other circumstances funding and pots of money are sometimes set aside to deliver improvement in a particular area. However, as she says, the Bill is incapable of bringing forward funding in that regard.
I thank the hon. Gentleman for giving way. The hon. Member for Great Grimsby (Lia Nici) makes a valid point. 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?
I am not familiar with the discussions the hon. Member may or may not have had—I am sure the hon. Member did have them—with the Government in relation to pots of money. Again, I will gently say that there are enormous pressures on NHS budgets. That is why we have NICE, for example, to take out some of the emotion and personal feelings people have in relation to clinical care, and to try to look objectively at what secures value for money. I am not aware of what work the Department may have done on whether this represented an equitable use of resources for this particular area of clinical care. I will be happy to write to the Minister and make inquiries, as I am sure Opposition Members and the all-party group have done.
On cost-efficiency, does the hon. Member not agree that, considering the cost of emergency admissions to hospital and the use of intensive care and expensive medicines that do not work as effectively, this system would be a much better use of national health resources and would actually be a financial economic benefit to our nation, not a detriment?
I agree. I am sure that that is part of the reason why some treatments secured a licence and NICE approval. Again, we must not give the impression to people listening to the debate that the NHS’s systems are not engaging with this issue. I am sure that some treatments were approved. I am sure—or would hope, if the evidence is there—that future treatments might also secure approval as we go forward, particularly if the evidence is there to demonstrate that they are of use. 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. I have direct experience of it, and it is not just an issue for the NHS; it is a global issue for modern healthcare systems when a vast amount of money is going into medical research with new treatments all the time. Governments need systems to decide which treatments they approve and so that they can look at the evidence properly. That is why we have the MHRA, NICE, the royal college guidelines and NHS best practice guidelines. All those things are in place.