Mesothelioma (Amendment) Bill [HL]
Lord Winston Excerpts(9 years, 7 months ago)
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Lord Winston (Lab)
My Lords, it is a pleasure to congratulate the noble Lord, Lord Alton, on introducing the Bill. I agree completely that this is a terrible condition that causes massive injury to a number of people.
I want to take a slightly different tack during this debate; I would like to put the disease into some focus. I was first aware of mesothelioma in the 1960s as a medical student. I worked with a very great physician, the late Donald Hunter, who was probably the first person really to identify industrial diseases as a major issue in medicine. He was very prominent in the field of lung disease—pneumoconiosis in miners, for example. He also had further interests in a whole range of things; he even changed the way that diamond drills were used in South Africa to reduce the dust that would cause lung disease in miners.
Some noble Lords might remember that around 1998 I made a television programme about an Irish individual called Herbie, whom we filmed dying. It was a unique film that was part of “The Human Body”. It was massively criticised before it was shown because it was the first time that anyone had filmed a death on television. We filmed Herbie over the best part of two years. It was an amazing experience for me. He was dying of mesothelioma. Interestingly, while of course I bow completely to what the noble Baroness, Lady Finlay, points out about the pain, the pain from his abdominal mesothelioma was quite well controlled by pretty heavy amounts of morphine-like drugs. Extraordinarily, the fact that we filmed him for so long probably extended his life. Amazingly, he lived for at least a year or two longer than was expected by his physicians. We all went to the funeral and filmed that as well, and it was a very moving moment. The value of that was partly to show someone dying from a disease of this sort but also to recognise that there is not necessarily a need to have such fear about death, a very important issue on which I think the noble Baroness will understand where we were coming from. Once the film had been shown, it did not receive any more aggressive comments in the press; it was recognised as being quite important.
Mesothelioma is an extraordinary disease. I shall try to make it understandable. Our lungs, or rather the pleural cavity in which our lungs are contained, are lined by a lining that covers the heart and the contents of the abdomen, including the bowel. The tumours arise from this lining. Unfortunately, unlike epithelial cancers—most cancers are on epithelial tissues—cancers that arise from these embryological tissues have always been much more resistant to treatment. They include tissues that grow from the bone, such as sarcoma, although I think that that is now changing a bit in its impact. None the less, there is no doubt that these conditions are recognised as being astonishingly hard to deal with.
There is no doubt that mesothelioma is primarily caused by exposure to asbestos, almost invariably in the lung and probably in the abdomen as well. It is true that about one-fifth of patients claim never to have been in contact with asbestos but, as the noble Baroness, Lady Finlay, eloquently points out, it is obvious why that might not be so. It is also interesting that the epidemic, as it has been called, that we have at the moment may be on the decrease as asbestos—particularly blue and brown asbestos, the most dangerous forms—is controlled and regulated. Sadly, however, we have not done nearly enough, so the pleas for much better understanding of what we must do in public and private places go without question.
I will declare two interests. First, I am still a research academic at Imperial College, and my most recent project grant has a cancer edge to it, although it is not on one of these cancers. It has not yet been awarded—I may not get the money—but I hope that it will be funded in due course. The other reason for declaring an interest is that many years ago I was a trustee of Cancer Research UK and before that the Imperial Cancer Research Fund. I emphasise to your Lordships that Cancer Research UK raises between £300 million and £400 million a year for cancer research. It also has a number of notable scientists; for example, there are at least two Nobel prize-winners I can think of immediately: one is Paul Nurse, and the other of course is the recent Nobel prize-winner, Tom Lindahl. They both look at cells—cell development, cell cycle, cell division, and what interrupts them. I make it very clear that that kind of research these Nobel prize-winners have done, which is typical of many people in cell biology, has a profound effect on our understanding of all cancers. Their research is not focused on mesothelioma, but it does not mean to say that it is any less relevant. It is very important to understand that an understanding of how cells work is as important as any specific, targeted approach to a particular condition.
There is always a slight risk of targeting one or two particular diseases at the expense of other diseases. We have to be aware of this, particularly when perhaps smaller charities are involved in targeting a particular disease because of an interest group. Cancer Research UK says very clearly that it is very happy to help smaller charities and help fund research where it is properly peer-reviewed, to improve and increase their impact. However, it is also very clear that Cancer Research UK, which is our main cancer research organisation in this country, has not ignored mesothelioma. On the contrary, if you look at its website, you will see very clearly that it is involved with a number of research projects. I will delineate some of the areas, because it is very relevant to this debate.
First, Cancer Research UK has been very clearly interested in the past in seeing whether there might be causes other than asbestos; for example, a viral cause. There is probably not a genetic cause either, but there may be a genetic predisposition to how you react to the tumour once it is being treated. One of the problems with mesothelioma is that it is very difficult to diagnose and often appears late. That patient, Herbie, for example, was diagnosed very late, and when I was active in surgery years ago I opened the abdomen of someone in pain to find that they had a mesothelioma, although there had been no suggestion beforehand that there would be a mesothelioma in that particular patient. Therefore one of the approaches that Cancer Research UK is trying to achieve is slightly earlier diagnosis. In particular, there are two promising compounds: one is osteopontin and the other is the serum mesothelin-related protein, both of which are secreted by these tumours. Unfortunately, one of the problems is that both these markers are secreted by other tumours as well, including, for example, ovarian cancer. Getting a specific marker is a difficulty, but research will continue.
There is no question that in the field of treatment there is a great deal of research. I have a list here, which I have written down, of the number of chemotherapeutic agents which have been looked at. In recent years I can count at least 10 or 11: raltitrexed, gemcitabine, mitomycin, vinorelbine, irinotecan, vinflunine, and there are various combinations of those therapies with other well-known mitotoxic agents. These have included trials; I do not quite understand the figures for funding which have been put round the Chamber, because of course clinical trials, which are often multi-centred, are extremely expensive to carry out, and whether those are included in the figures which are being bandied about is very questionable. The noble Lord, Lord Prior, may have something to say about that issue. We would like to see more trials, and they are expensive, but I do not know whether they are included in the total cost of the research into mesothelioma that is being quoted.
Other treatments have been researched: of course there is surgery, pleurodesis, and there are now attempts to try to reduce the tumour inside the lung membranes. However, some of the more promising therapies which are being actively looked at by Cancer Research UK are biological therapy and immunotherapy. So far, none of these drugs works particularly well. At least 12 have been looked at; there is some promise, and there is no question but that used in combination they may improve. However, these remain, like so many other of these tumours of similar embryological origin that are not mesotheliomas, quite resistant to treatment, just as they become resistant to therapy. Incidentally, photodynamic therapy has been tried.
I do not want to go on at great length about research, but I will talk about three trials that Cancer Research UK is doing at the moment to emphasise the wide range of stuff that is going on. One is some work with HSV1716, which is a virus that acts against dividing cancer cells. It comes from the herpes virus, if I remember correctly. Therefore that is a very good example of where we might make a breakthrough in treatment. Then there is a different strand of research with ADI-PEG 20, which in combination with other drugs such as cisplatin affects a particular amino acid in the chain of cell division. The amino acid that is of particular importance here is arginine. If that can be inhibited, the cancer cells do not multiply. That has been specifically targeted for the treatment of mesothelioma. A compound, GSK3052230, developed by GSK, is I think about to enter phase 3 trials very shortly. That attacks the FGFR1 gene, and therefore stops cancer cells growing.
It is therefore important to emphasise that we are doing research in this country. Whether we are doing enough remains for other people to decide. However, it is important to recognise that these cancers are very resistant to all sorts of treatment, which is one of the reasons why they are so emotionally as well as physically painful. I also suggest that we have heard so many times before about how it has been decided by Governments to put massive funding towards a particular biological project. I think President Nixon said, “We’ll put funds into conquering cancer”, and that was a total failure. We need to understand that of course there need to be targeted funds, but there also needs to be an understanding of the basic mechanisms. That is definitely going on with a wide range of cancers, some of which will affect mesothelial cancer research as well as lung cancer, bowel cancer and testicular cancer research. It is very important to understand that it is not just about simply focusing on one disease which is of terrible significance, not least because it is almost invariably fatal.
Lord Prior of Brampton
It is hard to know what the right figures are. After this debate, we need to sort out exactly what the figures are.
Lord Winston
I hate to disagree with my noble friend, but one problem with mesothelioma research is that Cancer Research UK, for example, puts such funding partly in the box of lung cancer funding—it is a different form of lung cancer. There is a risk that we may be underestimating the amount of money being spent. That always happens when these figures are bandied about. I am not suggesting that we should not be spending more—or less—but it is very difficult to be precise about the figures sometimes cited.
Lord Prior of Brampton
We probably cannot today sort out the figures in the way we would like. It will be very difficult to allocate some of the more generic research expenditure. Let us move on from funding, if we can.
Lord Prior of Brampton
I think the answer to that question is that the Health and Safety Executive would have prime responsibility for them. I think the point that the noble Baroness is making is that the local authority no longer has the responsibility it would have over local authority schools. I will look into that issue and write to the noble Baroness.
Lord Winston
Before the Minister sits down, and I apologise for prolonging this debate for longer than necessary, does he agree that medical advances in every field are often very serendipitous? The classic example would be the completely unfunded discovery of penicillin when it was first produced, and it was subsequently only mediocrely funded until we had a wartime crisis.
In about an hour’s time the Minister will be answering a Question about doctors’ overtime. One of the critical issues that has not been discussed in that debate has been raised by Jeremy Farrar, the director of the Wellcome Trust, who points out that one of the real issues is the problem with young doctors being able to do research in a very generic way, which has all sorts of benefits, including clinical mesothelioma research. That is a fundamental problem. We in this country are very good at medical research and on the whole we fund it quite well, although obviously we would like to have more funding, but providing the environment for continuing research is essential for what we are discussing in this Second Reading debate.
Lord Prior of Brampton
I thank the noble Lord for that comment. We in this country are often highly self-critical but actually we have a remarkable record on research. We have three of the top medical academic institutions in the world in this country: Oxford, Cambridge and Imperial. We have UCLH, King’s and Manchester. We have some extraordinary research organisations in this country. There is, I guess, an issue over quality and quality control. There are an awful lot of clinicians who do research that may not be to the—
Junior Doctors Contract
Lord Winston Excerpts(9 years, 7 months ago)
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Lord Prior of Brampton
My Lords, the threshold for strike should be very high because of the vocational and professional dedication of doctors. Certainly, the threshold should be higher than it usually is for pay and conditions issues such as the one before us today.
Lord Winston (Lab)
My Lords, I deeply regret the tone of the statement. I understand that that is not the responsibility of the noble Lord, Lord Prior. I also respect very much his attitude, which is, I think, respected by the whole House. We have to say very clearly that this is an unprecedented situation. I do not think the nature of how junior doctors feel is understood. Already, there are more doctors in medical schools looking at going overseas—they are actually asking me whether they should be working in this country. The key issue is one we discussed in today’s earlier debate: the backbone of a good NHS is the good research we do. Research is massively threatened by what the Secretary of State is proposing. That has been emphasised by Jeremy Farrar, who, after all, is a very independent person as head of the Wellcome Trust. Would the Minister be kind enough to address that issue?
Lord Prior of Brampton
I agree. It is tragic that we are in this situation. My son is a medical student and I meet many of his friends; they do not want to be in this position. Concerns have been raised about whether junior doctors will have time to do research or will lose out on their progression if they do. That should be discussed and argued out with the BMA sitting around the table.
Mental Health Services
Lord Winston Excerpts(9 years, 8 months ago)
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Lord Prior of Brampton
It is too early. I cannot give the noble Baroness specific figures for last year’s spending, but we believe that they will show an increase of some £300 million over the year before. We have made it very clear to NHS England in the mandate that we expect spending on mental health services to increase this year and that every CCG in the country will see a real-terms increase in mental health spending compared with the previous year.
Lord Winston (Lab)
My Lords, we are very grateful that money is being spent on waiting times, but will the Minister be kind enough to comment on a particular situation that occurred just a few weeks ago? The husband of a colleague of mine had a severe manic episode and was in a hospital casualty department for the best part of the day and the whole night, most of the time not being seen. He waited for two days before a bed could be found, not at that hospital, nor at his local mental hospital. Eventually, a bed was found some distance away. Does the Minister feel that that is satisfactory?
Lord Prior of Brampton
The noble Lord makes a very good point. It is totally unsatisfactory that beds are not available for people suffering a severe mental health crisis. However, looking at the research done by the noble Lord, Lord Crisp, it is not the number of beds that is a problem, but the use of the beds we currently have. Far too many people still in in-patient beds could be treated outside. The answer is not more beds, but using the beds we have more effectively. I completely agree with the noble Lord. What he described I have seen myself. It is totally unsatisfactory.
Local Authorities: Public Health Budget
Lord Winston Excerpts(9 years, 11 months ago)
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Lord Prior of Brampton
I think that the noble Baroness will know that we are due to go out to consultation on this matter, and that is an important issue that will be taken into consideration.
Lord Winston (Lab)
My Lords, does the noble Lord not recognise that this Question goes much broader than just the confines of the issue that we are discussing? Local authorities have an effect on the environment, transport, housing, poverty and a whole range of social issues that absolutely affect public health. Until that is sorted out, this is going to be a major problem in this country.
Lord Prior of Brampton
The noble Lord makes a good point that goes considerably broader than the Question. I accept that many of these things are inextricably linked.
Health: Multiple Pregnancy
Lord Winston Excerpts(10 years ago)
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Lord Prior of Brampton
My Lords, the level of stillbirths in England is too high, whether from multiple or single births. The MBRRACE-UK report indicates that if we had the same rates as in Sweden or Norway, many more children would survive in this country. One of the problems that the noble Baroness puts her finger on is that the tariff system may discourage some neonatal units from referring cases to specialist referral units.
Lord Winston (Lab)
My Lords, the large number of multiple births in this country is very largely due—probably half due—to the practice of in vitro fertilisation. A very large number of patients are coming into this country having been referred to clinics overseas that do not accept the regulations on limiting embryo transfer. Does the Minister have figures on this and is there something that the Government can do to stop this practice, which is seriously increasing the cost of perinatal care and the tragedy for mothers?
Lord Prior of Brampton
The Government may have figures on this. I do not have figures here today, but I shall certainly endeavour to find them as soon as I can and perhaps follow it up with the noble Lord in a meeting outside this House.
Maternity Services in Morecambe Bay
Lord Winston Excerpts(10 years, 4 months ago)
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Lord Patel (CB)
My Lords, I have to admit that, as an obstetrician, when I read this report, my immediate response was intense anger, anger at this systems failure on a grand scale. None of these things should have occurred. This is not an example of failure of a mild degree or of a relationship. This is failure on a major scale. No maternity unit in the country would tolerate these kinds of tragedies occurring in their own unit.
I commend the report. I have worked with the chairman and several of the expert advisers. Dr Kirkup worked with me when I carried out the inquiry on cancer services in Gateshead. He was a member of the team and I know the others, particularly as they come from my own hospital. Professor Stewart Forsyth was neonatologist with me, and I know James Walker, whose father is responsible for all the successes I have had in obstetrics and none of the failures. His name was also James Walker.
What can we do? There is the idea of mandatory reporting of unexpected maternal deaths and stillbirths. We have a stillbirth rate in the antenatal period that has not reduced in this country for 40 years. We have unexpectedly high numbers of normally formed babies who die in the interpartum period but who should not die. If that kind of tragedy ever occurred in my unit, there was a major investigation immediately afterwards. Mandatory reporting may highlight this issue because we need to address it.
I will focus on one recommendation of the several that are addressed regarding the professional organisations in medicine and midwifery. They need to step up to the plate and respond positively to this report on what their role will be in making maternity services safer in this country. The noble Earl referred to an airline-type investigation for root cause analysis. I accept that that is absolutely necessary but it requires experience and training and it must be done soon after the event to learn the lessons that might be applicable to other maternity units. I am encouraged to hear that NHS England will carry out a review of maternity services and I hope that it will be an in-depth review with the specific purpose of making maternity services safer. It should not be about demarcation issues with which we got ourselves tied up previously between different professional groups. It should not be about relocating services. It should be about making maternity services safer.
I have lots of questions but they are not for today and I will save them for another time. I hope all of us—no matter who the Government are—will now work to make maternity services in this country among the best possible.
Lord Winston (Lab)
Does the noble Lord not agree that one of the key issues is that nurses as midwives and obstetricians no longer work together as a team? They work separately and conflict with each other instead of seeing patients together. Would that not solve many of the problems identified in this shocking report?
Lord Patel
The noble Lord is absolutely right. That is why I said that the review must address how to make maternity services safer and not address any of the demarcation issues. I work with midwives. Midwives taught me—I have said that before in this House—so there should be no issues between different professional groups, whether they be nurses, midwives, doctors, neonatologists, anaesthetists or whoever.
Health: Obesity
Lord Winston Excerpts(10 years, 4 months ago)
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Earl Howe
I think that we should give money to local authorities, nevertheless, but I take my noble friend’s point: overweight and obesity are a direct consequence of eating and drinking more calories and using up too few calories. That is the message that we need to get across.
Lord Winston (Lab)
My Lords, have the Government taken into account the issue of epigenetics in their advice on obesity? For example, is the Minister aware of the research by Gregory Dunn of the University of Pennsylvania which has shown that a great-grandmother can pass on imprinted genes which affect her great-grandchildren, but only the females and not the males? That argues environmental influences that we do not yet understand. Is that being factored in with the advice that the Department of Health is giving? It will be an increasingly important issue. This is not only a question of overeating; it is a very complicated problem.
Earl Howe
Yes, my Lords, that is being factored in, but I do not think that we should confuse that point with a certain sort of fatalistic approach to obesity. There are things that people can do with their lifestyle to influence their own states of health in all sorts of areas and we have to help people understand what those things are.
Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Lord Winston Excerpts(10 years, 4 months ago)
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Lord Winston (Lab)
I wonder whether I can help my noble friend Lord Patel. Does he agree with me that there were very few available data for the first in vitro fertilisation babies, and that that was a step in the dark, as were pre-implantation diagnosis and sperm microinjection? Before he concludes his speech, would my noble friend be kind enough to answer an important question asked by the noble Lord, Lord Deben, about the possibility that we might be making infertile children? Was that not the accusation made when infertility was treated by in vitro fertilisation, and was there not a widespread fear at that time, too, that we would be making infertile children?
Lord Patel
I thank my noble friend for that interruption. It was worse than that: it was suggested not only that those children might be infertile, but that they might be half monsters of some kind. To answer the question raised earlier about the HFEA’s evidence—yes, it did ask, and the evidence was verbally produced. The reason why it is not published is that anything that is published, even in the form of an extract, cannot then be published in a reputable journal. I know that that evidence has now been sent for publication.
To go back to the subject of the evidence requested, if we were to go down that road and do those experiments, what would be required in the human population is the deliberate creation and destruction of many hundreds, if not thousands, of embryos—to prove a point that does not require proving. Hundreds and thousands of human embryos have already been tested and found to go to a blastocyst state, and I hope my noble friend Lord Winston will agree that if we see them in that state, the embryo will be satisfactory. He nods slightly.
The alternative would be human population genetic studies to fulfil that requirement for evidence. What that shows is that exchange of mitochondrial DNA haplotypes by normal reproduction should reveal combinations that are deleterious. Human population genetic studies will do that. Such studies include genome-wide association studies and whole genome sequencing projects looking at many specific diseases and syndromes. Those kinds of studies will be required. They do not require embryos to be created, nor is it necessary to do these studies before this treatment is available.
I know I am going on a bit, but other points were made. If there are points about epigenetics et cetera, those are also spurious and have no basis in science.
Let me go now to something that the noble Lord, Lord Deben, mentioned twice: the Chinese example. The technique that was used in the United States and in this Chinese example is called cytoplasmic injection. No doubt the noble Lord, Lord Winston, is more familiar with it from his work than I am. It is a technique that is not allowed in the United Kingdom. That is the first point. It is completely different in design and intent from what we are talking about in mitochondrial replacement; it is nothing to do with it.
What was done in China was a cytoplasmic injection not for replacing mitochondria, but for infertility treatment in older women. That was also the case in the United States; it was an extra cytoplasm with possible mitochondria in older women, where both are at risk of producing chromosomal abnormality. In China it was used in only one study, which was conducted by an American, Professor Grifo. They inserted five embryos. We do not allow that in the United Kingdom because of the risk of multiple pregnancy. It resulted in a multiple pregnancy. They then tried to reduce the number of foetuses by injecting one of them to reduce the number of foetuses from three to two. I do not know what kind of technique they used—
Lord Patel
“Dangerous”, my noble friend says. It killed the other two and resulted in a premature birth. They never published this, despite being asked if there was a publication. It is wrong to say that the HFEA did not ask them; the review panel did. Professor Grifo sent a letter saying that, in his view, all the foetuses were normal but they died of prematurity. What they died of was an obstetric botch-up. It had nothing to do with what we are talking about today. It was a completely different technique. We should dismiss it completely. It would be wrong to put any credence on it and say that it is a good reason why we should not do this.
I could go on about other safety aspects that were brought up, but let me close by saying that hitherto the science has gone as far as it can in thousands of animal experiments that have resulted in normal pups. In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on. None of us stops researching: the noble Lord, Lord Winston, still carries on researching; the noble Lord, Lord Kakkar, still carries on researching. If a chance was given, the noble Lord, Lord Walton, would still carry on researching. We do not stop researching; that is the nature of medicine and of academic medical science. I hope that we will pass these regulations.
Baroness O'Loan (CB)
My Lords, I very much support the Motion that has been tabled by the noble Lord, Lord Deben, for the reasons he very articulately expressed. The Minister has reassured us significantly about these regulations, but he did express many of the uncertainties that remain. In moving his Motion, the noble Lord, Lord Deben, talked about uncertainty. The noble Lord, Lord Patel, gave us graphic details of the uncertainties of the two processes that are proposed, which may result in increased risk of chromosomal defects. In the light of all that uncertainty, how can it be right that your Lordships’ House be asked to make a decision of this magnitude before the conclusion of all the necessary research?
I want to talk briefly about one issue that relates to the protection of women’s health. We are told that these proposals are all about advancing women’s rights, and yet it seems to me that we are at risk of overlooking one very important matter in relation to which these procedures plainly do not advance women’s rights. That is the repercussions of the increased demand for donor eggs for the women who donate the eggs. The requirement for more eggs is a consequence of scientific development, and that is widely accepted. A Nuffield Council on Bioethics report looked into the ethical issues around mitochondrial donation and stated:
“One of the major barriers mentioned by scientists when assessing the potential for cell reconstruction techniques to become treatments is the fact that many more egg donors will need to be found to undertake the research required in order for the safety and efficacy of PNT and MST to be established, and if therapies are to be provided in future. A shortage of egg donors is an acknowledged problem in respect of donations for reproduction, and it is not yet clear whether egg donors would be more likely to come forward”.
Lord Winston
I am grateful to the noble Baroness for giving way, but I do not think that she speaks from experience. Sadly, I have to say that I do speak from experience. I have run a very large infertility practice for a very long time, and we found donors very easily when it was concerned with these sorts of serious conditions. There was never a problem about finding donor eggs for this kind of problem.
Baroness O'Loan
I thank the noble Lord for that intervention. I am not arguing against this process; I am arguing against the introduction of these regulations at this time in the absence of sufficient knowledge and protection. We have to look at the factors, as the noble Lord, Lord Alton, said. Being paid to donate one’s eggs constitutes a very serious issue for women who are in poverty and who will do it as a way of raising money, possibly even to look after their own children. We need to provide protection for such women.
In conclusion, we should not hasten ahead without putting in place clear and comprehensive systems for monitoring the outcomes of all controlled ovarian hyperstimulation treatments, including those treatments that would result in the generation of eggs to facilitate PNT and MST. In this context, I simply ask that we proceed more carefully and that we back the Motion moved today by the noble Lord, Lord Deben.
Lord Winston
My Lords, I declare an interest in that it was my scientific group which started pre-implantation diagnosis—the first attempts to diagnose genetic diseases in embryos in families who have these fatal, sad genetic flaws in them. I congratulate the Minister on his absolutely balanced and fair speech. From time to time, we have not agreed, but I think that his care, compassion and courtesy are deeply appreciated by the whole House. I also congratulate the noble Lord, Lord Deben, on his very clever speech. I do not agree with what he said and I hope that, at other times, we can see why we disagree. I accept that he is talking with deep conviction, but I think that we have already sorted out most of his objections, both the legal and the difficulties of side-effects.
Baroness Scotland of Asthal (Lab)
My Lords, before my noble friend goes any further, I say to him that there are real differences in legal opinion. I do not think that we have quite sorted them out yet.
Lord Winston
I am very grateful to my noble and learned friend for that.
I want to do something which I have done previously in debates of this kind, which is to talk from personal experience. I may be one of the few people in the House who have sat with an endless number of parents who have a genetic disease in the family, have listened to their problems and have seen the kind of dilemma that they face. I am reminded of the child Jeremy “Martinez”—forgive me if I change the surname, but I do not have approval to give the surname of that patient from some time ago. We were doing in vitro fertilisation and pre-implantation genetic diagnosis in the 1980s, and the first babies, who are now 25, were born in 1990. At that time, we were looking at the very common genetic disorders. It is interesting to consider that there is a vast number—too many, some of us think—of Members of this House. At least 40 of you, on mathematical probability, will carry the fatal genetic mutation for cystic fibrosis. That is very common indeed and much more common than the problem with mitochondrial disease, even though we are beginning to see that it is becoming rather more common as we get better molecular techniques.
What is very clear, and it is very important because it has not been stated, is that the number of families who will be of child-bearing age when a mitochondrial disease is diagnosed will be very few. That is important because we are not talking about a large number of people; we are talking about a small number, but they have a definite problem for which they need some desperate solution. They are prepared to do whatever they think is best for their families, with informed consent.
In the case of Jeremy, he was a bit slow to grow, but by nine months he could not lift his head. He started to vomit; he had diarrhoea; he then progressively developed muscular weakness and started to get epileptic fits. These fits would often go on all night; this child screamed with pain and was uncontrollable; eventually, having gone both blind and deaf, with severe mental problems with his brain, he died at the age of two. There was no treatment. His mother came to see me to ask if there was any possibility that she might have some screening of her embryos in the future. This was in 1989. Certainly, Alan Handyside and I had discussed the possibility of looking at mitochondrial disease, but we did not have the molecular techniques at that time to have any chance of being able to screen an embryo. It is true that that screening has now happened and can be done; indeed, there is a very interesting report from Newcastle University showing how that can be done in some cases. However, it is not always satisfactory, for the reasons that the noble Lord, Lord Patel, stated.
Lord Patel
I think that the noble Lord was asking him to reply to my comment. He is quite right that China has used pronuclear transfer techniques, but the disaster was upsetting to me.
Lord Winston
I am very concerned that the noble Lord, Lord Patel, might get into trouble with the Whip sitting on the Front Bench. I am always in her bad books, and I would not want to allow him to be in her bad books as well.
Let me answer the noble Lord, Lord Alton. It is true that, two years ago, I said that it was unpredictable; of course, these things are unpredictable. In the context in which I was speaking, that was correct. To be fair, however, the noble Lord, Lord Alton, knows that, with the case of Jacques Cohen in New Jersey, 17 babies were born after mitochondrial transfer. Therefore, there has been some other evidence—other than that evidence from China—that suggests that this is not quite as daft as proposed. Added to which, of course, in two years, a huge amount of research has been done by our colleagues in Newcastle. They have been working flat out on a whole range of tests which, I think, have made a very big difference. Since the statement that I made in the House, three different committees have looked at the safety.
Science does not have the truth; we have a version of the truth. We have to interpret what we can as best we can.
I deeply respect the noble Lord, Lord Alton, as he knows very well. We both come from a very strong view about what is the right thing to try to do wherever possible. However, I feel here that, apart from the issue of preserving healthy life, if we decide not to vote for the amendment of the noble Lord, Lord Deben, we are doing something really important. We are expressing our concern—our compassion—as a House for people who are faced with an invidious and horrendous choice.
Under those circumstances, given that this will be a limited procedure affecting very few people, it would be utterly wrong for this House to turn down the democratically elected Chamber and not to support what the Government propose.
Lord Walton of Detchant (CB)
My Lords, at the outset, I have to declare two interests. First, I am the honorary life president of Muscular Dystrophy UK, which, along with the Wellcome Trust and other organisations, has been sponsoring and funding some of this research. Secondly, I have to say that I have an avuncular interest in the department in Newcastle upon Tyne, because Professor Douglas Turnbull, who now holds the chair of neurology in that university, holds the chair which I held 32 years ago.
I say just in passing to the noble Lord, Lord Deben, to whom I listened with the greatest possible interest, that he may not remember that I was the neurologist on the Southwood working party, which advised his department on BSE and produced a report which ultimately led to the disappearance of BSE and its human form, Creutzfeldt-Jakob disease, so he does not need to lecture me about the precautionary principle.
There is one sensitive matter which I feel that I must raise at this stage. I am a lifelong member of the Methodist Church, although I at present attend an Anglican church. I know full well that from the very first day that the whole issue of human fertilisation and embryology came before this House, it was bitterly opposed by the Roman Catholic Church. I do not suggest to either the noble Lord, Lord Deben, or my noble friend Lord Alton that their adherence to and strong faith in the Roman Catholic principles has in any way influenced their attitude to the regulations; but at every stage from the first regulations to allow human fertilisation and embryology to take place, they have been bitterly opposed.
I must confess that I did discuss the whole issue of the status of the human embryo with an old friend, the late Cardinal Hume, whose father was a professor of medicine in Newcastle, Sir William Hume, who taught me briefly when I was a medical student in the early 1940s. Cardinal Hume and I discussed the whole issue, and I told him that I simply could not accept what the Roman Catholic Church has now decreed. Many, many years ago, St Thomas Aquinas said that life did not begin until the foetus was capable of independent existence outside the womb. It was a Pope in the 19th century who decreed that life began at the moment that the sperm entered the egg.
I said to Cardinal Hume that I really could not believe that a small bundle of cells carries the same status in society as a mature adult, and that that was something with which I profoundly disagreed. We discussed it and regularly went on to have a powerful exchange of views and then to decide that we could not agree, but then moved on to discuss a matter of much more mutual concern: the fortunes of Newcastle United Football Club. When, in 1980, the city of Newcastle decided to create a number of new honorary freemen to celebrate its 900th anniversary, among them were me as dean of medicine, Cardinal Hume and Jackie Milburn, the former England and Newcastle centre forward. Cardinal Hume said that it was the greatest day of his life: all his life he had been waiting to meet Jackie Milburn.
Lord Winston
Before the noble Lord does that, I wonder whether he would consider this point very seriously for a moment. If we delay this measure, we will, as I am sure he understands very well, be committing a number of people to terminating pregnancies. Not only will we be terminating their pregnancies but those women will experience a number of lost pregnancies—a loss of life. Is that what the noble Lord really wants in pressing this amendment?
Lord Deben
I do not want to prolong this but the fact is that the human embryology committee and the terms under which it can give the permissions will take longer than it would take to have the committee that I am calling for in my amendment. It would not hold matters up for one moment. However, I think that the House wants to go to a vote.
Medical Innovation Bill [HL]
Lord Winston Excerpts(10 years, 5 months ago)
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Lord Winston
Lord Winston (Lab)
My Lords, I shall not detain the House for great length. The amendment in my name and that of the noble Lord, Lord Saatchi, addresses patient safety, an issue which is dear to this Government. One of the concerns expressed again and again throughout the Second Reading and Committee stages of this Bill, and subsequently, has been that some patients might in desperation, for various reasons, seek treatment which is innovative but not properly regulated or properly justified. Particularly in the private sector, patients might be tempted to go into treatments which seem attractive but perhaps are overadvertised as sensible. In the end, they may be more futile than more recognised treatments that may carry known side-effects or perhaps be more frightening. I think that that is the case for cancer in particular.
This amendment is designed to make sure that any treatment given under this Bill would get broad support from responsible medical practitioners. There would be an onus, not only on the person doing the treatment, but on the person responsible for advising that the treatment was reasonable to the operator, the medical practitioner concerned. This would fall within that area. Essentially, there would be a legal onus, a responsibility, for that adviser to give advice which was regarded as serious and acceptable to a broad body of medical opinion in that field. That is the essence of this amendment, which we have discussed.
I am delighted that the noble Lord, Lord Saatchi, has agreed to put his name to this amendment. It is helpful. I hope that it will not prevent people participating in trials, particularly in cancer medicine. I also hope that it will make sure that private medicine is carried out responsibly. We all have reservations about this Bill but it covers most of the issues about which we have been concerned. I am concerned about reproductive medicine because I fear that that is now in a burgeoning private area. It worries me still that quite a lot of reproductive medicine done in the private sector is not properly validated and that patients are paying very heavily for it. Beyond that, broadly speaking, this is the amendment that I would like to see on the statute book. I therefore beg to move.
Baroness Gardner of Parkes (Con)
My Lords, I am slightly concerned about the wording of the amendment because I would not want it to become a way of dragging things on forever. How do you decide what is,
“a representative body of responsible medical opinion”?
To lay people such as myself, there seem to be heaps of medical bodies and I wonder how that would be determined. I would be interested to be satisfied on those points. The speech of the noble Lord, Lord Winston, was clear that he does not intend the amendment to represent any of those matters, but I would like someone who is more of an expert on the wording of these things to assure me that it would not be only a preventative technique.
Lord Saatchi (Con)
I thank noble Lords who have addressed this amendment. I happily added my name to the amendment of the noble Lord, Lord Winston, because I believe that it provides helpful additional clarity for Peers and those outside the House about the intention and effect of the Bill.
Your Lordships will be aware that on a number of occasions I have tried to stress that the intention and effect of Clauses 1(3)(a) and (b) are not, as my noble friend was just saying, that a doctor can just ignore the views of anyone who disagrees with the proposed treatment or that he or she can choose to consult only those who are known to agree. I agree with my noble friend that Clause 1(3)(a) and (b) contain a legal duty to obtain views and take proper account of them, and that that is a serious and effective threshold. However, I wonder whether I may encourage my noble friend to share with me the observation that a number of noble Lords, including the noble Lords, Lord Winston and Lord Turnberg, were anxious to see this set out more expressly in the Bill in language that at least resembles, if not copies completely, the wording of the Bolam test, as described by the noble Lord, Lord Pannick. I believe that the amendment of the noble Lord, Lord Winston, does that in a manner that will not change the substantive policy of the Bill, as already agreed by your Lordships, but will perhaps give greater clarity about the intention for those Peers and others who want to see this language expressed in the Bill in the closest approximation possible to the existing Bolam test, which is what we are all trying to preserve.
As your Lordships know, the Bill is all about giving greater clarity and certainty to patients and doctors at the point of treatment, and not forcing them to wait for the unpredictable outcome of possible litigation or disciplinary proceedings. I can only welcome any amendment designed to enhance clarity and certainty about the effect of the Bill itself. I am therefore very happy to support it.
Lord Winston
My Lords, as this is probably the last opportunity I will have during the passage of the Bill, I thank the noble Lord, Lord Saatchi, who has behaved with extreme courtesy throughout the debate on this Bill. We do not entirely agree, but I think we have come to respect each other’s point of view and we are in total agreement about this issue.
I was surprised that the noble Baroness, Lady Gardner, raised this concern, because a representative body of medical opinion is exactly what courts ask me to give and to be mindful of. I am very grateful to the noble Lord, Lord Pannick, for his quotation, which is of course now on record, because on the number of times that I have been an expert witness in court, that is exactly what my Silk, in taking evidence from me, has required me to recognise—whether I am doing something that is recognised by a responsible body of medical opinion. That is a phrase which is firmly in our minds and was therefore firmly in my mind when I set this amendment down.
I therefore really am disappointed with the response from the noble Earl, Lord Howe, on behalf of the Government. If the Government really want to protect patient safety—I have no doubt about their absolute commitment to that—this would be a very good way of doing that. It seems to me that there is a risk of mavericks operating without that control. This is a very shocking issue. We do have desperate patients seeking all sorts of treatments, sometimes at the end of life but often perhaps because they are infertile— which is hardly at the end of life—and they will go through anything that they think might be of benefit, even though it is not proven. That is innovative treatment and sometimes it is possible that for various reasons that innovative treatment might work; sometimes, purely biology works and random effects happen. The amendment is designed to deal with that issue.
I do not think it would be appropriate to divide the House. I am grateful to see so many of your Lordships here late on a Friday afternoon, which is a great credit to this House and something we should be proud of. I am sure that the noble Lord, Lord Saatchi, is grateful as well. However, I feel that this is something that will need to be teased out. If the Bill now proceeds to another place, I very much hope that some consideration will be given to the patient safety aspect. Of course, it is really in the Government’s interests, particularly at the moment, when we are increasingly concerned, understandably, about our health service, which we all want to see survive and prosper. For the moment, I will withdraw the amendment.
Lord Ribeiro (Con)
My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s. Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation. At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland. In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response. Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay. That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it. On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.
Lord Winston
My Lords, briefly, I support the amendment of my noble friend Lord Hunt of Kings Heath as well. I was reminded by the noble Lord, Lord Ribeiro, of laparoscopic surgery. Of course, we gynaecologists were doing that 20 years before the noble Lord was and we did not have as many deaths. Having said that, what the surgeons did with laparoscopic surgery and recording those events was really important in bringing down the complication rate and the haemorrhages that occurred. That is a very good example and the noble Lord is to be thanked for bringing it to the House. It is exactly what would be covered here.
I would be astonished if the Government seriously opposed this amendment. I was very unconvinced by the noble Baroness, Lady Jolly, in the previous stages of the Bill. She did not seem to take on board exactly what we were trying to say about the need for keeping proper records, which is important in all sorts of ways. If you keep a record and it is done under this Bill then you are effectively legally protected. For that reason if no other that would be important, but in any case we have to build up the knowledge of our experience. We do that automatically in the laboratory. Every single thing we do in the laboratory, whether negative or positive, we record in our laboratory books. If we do not, we are not doing good science or science useful to the public. Here in innovative medicine, we are—whether we like it or not—doing a form of science because we are exploring our knowledge about what a treatment means. That is what science means. I urge the Government to support the amendment. I feel very strongly about this. If the Government were reluctant to support it and my noble friend Lord Hunt were to divide the House, I would certainly join him.
Earl Howe
Perhaps I may deal briefly with the question posed by the noble Baroness, Lady Masham, who asked whether the Bill would apply to patients receiving private treatment. The answer is yes. Any departure from the accepted range of medical treatments for a condition, whether that patient be receiving NHS or private treatment, would be covered under the Bill.
The amendment of the noble Lord, Lord Hunt, would change the test of negligence under the Bill. If accepted—and assuming that the appropriate professional requirements were created—the amendment would require a doctor to comply with any professional requirements as to registration of the treatment; that is, to register the treatment with a scheme for the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition. In other words, registering details and results of an innovative treatment on a data-capturing scheme would form part of the steps that a doctor has to take under the Bill.
Lord Woolf
My Lords, before the noble Earl sits down for the last time, I am very conscious of the kind things said by the Minister about my interventions, and I can assure him that I hold his approach to all matters of this sort in equally high esteem, if not higher. He is a lesson to us all in the care with which he approaches these matters.
Just before we leave the subject, I want to draw attention to the words,
“comply with any professional requirements as to registration”.
That is a very important limitation in the amendment because—as I understand it; I did not have anything to do with the drafting—it presupposes that there should be professional requirements. Surely we can rely on the medical profession to put in sensible requirements.
Lord Winston
Before the noble Earl sits down—although I do notice that he has managed to take his seat on the Front Bench—I would argue that of course it is not research; we accept that completely. But it is science within the meaning of the Latin word, which has the notion of knowledge, and of course it is wrong for us to exclude knowledge being dispersed and promulgated. Of course, the Medical Innovation Bill hopes to do this, and that is the point of supporting it. Otherwise, I fear that the Bill when enacted will be almost useless. This has been an issue of great concern and was the cause of correspondence this week from many different medical sources. I hope that the Government will consider that very carefully.
Earl Howe
Of course the Government will consider this carefully. Let me make it clear that I do not want to sound negative about the idea of data gathering. I am the first to recognise that that could be a major advantage of the procedures that my noble friend Lord Saatchi is encouraging within the scope of the Bill. I would not dispute that for a moment. My concern is that to build a further requirement into the test of negligence would be the wrong course to take, because that is how this amendment is framed.
Also, what would be the benefit if we do not engage fully with the medical community to make sure that doctors are able to use any registry that might be created easily and simply? If it does not work for doctors, there will be no benefit—so I think that we need to take longer over this. It is not a case of kicking it into the long grass, but in the time available we have not been able to come up with a precise solution, despite our best endeavours in our discussions with the GMC.
Medical Innovation Bill [HL]
Lord Winston Excerpts(10 years, 8 months ago)
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Lord Winston (Lab)
My Lords, this is a surprisingly complex Bill, and indeed the various amendments that have been tabled in the first group conflict with each other. As a consequence I will concentrate on only a few of them in order to get some clarity. The noble Lord, Lord Saatchi, talked about clarity and certainty when he introduced the Bill, but I feel that the whole of this Bill will increase lack of clarity and promote uncertainty on the part of patients, which is something that really concerns me. I must also say that, as it stands, I believe that the Bill is quite dangerous. I say that with great respect to the noble Lord, Lord Saatchi, to whom we are grateful for introducing something of this kind.
I should say to the noble Lord at the outset that all of us who work as medical practitioners and scientists want to see innovation. No one could doubt that, as my noble friend Lord Turnberg pointed out. My entire career in the health service spanning 40 to 50 years has been a constant series of innovations, and I have to say that never once have I looked over my shoulder and thought that there might be a risk of litigation as a consequence of my innovating. That seems to be the reasoning behind the purpose of this Bill, but I believe that the noble Lord is mistaken in his view that practitioners are concerned about litigation because of innovation. They are certainly concerned about litigation, but they are not concerned because they are trying to do things which they can clearly claim are in the interests of their patients. That is a really big problem.
Had the noble Lord, Lord Saatchi, along with his noble friend the Minister of health, decided to focus on certain other aspects, I would have argued that some of the permissions for research ethics would have been a very important issue to look at. They are increasingly inhibitory. I would also cite some of the problems that have arisen out of the Human Tissue Act 2004, which was introduced by a Labour Government. There is a number of other issues that could have been looked at, such as the fitness to practise regime of the GMC, which the noble Lord mentioned.
However, let me concentrate on the Bill. I will start with Amendment 17. The noble Lord, Lord Pannick, introduced some of the questions and I want to deal with those in a bit more detail. I must suggest that anybody who has a sensitive disposition leaves the Chamber at this stage because I am going to describe personal experiences, which, I have to tell your Lordships, are unpleasant. I can give endless examples but will confine myself to two cases of maternal care. In doing so, I declare an interest as the chairman of the Genesis Research Trust at Imperial College and, of course, as a formerly practising gynaecologist.
When I was in training in a district general hospital in Essex, I was confronted in the middle of the night with a woman who started to bleed torrentially after birth. The blood went completely over the obstetric ward floor and then started to leak out under the sill of the floor into the corridor beyond. It was very clear that no matter how fast we transfused this patient with all the blood we had available, and eventually with O negative blood, this woman was going to exsanguinate and there was absolutely nothing one could do about it. I tried an innovative procedure with that uterus that was not described in the literature but had I not done so, that patient would have died.
I have to say to the noble Lord, Lord Saatchi, that, unlike him, I have tangled with innovation throughout my life. I have had sleepless nights; I have had trembling hands when facing patients who might die because I knew that I had to take a decision on the spur of the moment that might make the difference between life and death. Amendment 17 is partly concerned with that, and if we do not press it today, I think we will need to reconsider it on Report.
I will tell the noble Lord another story. This is pretty graphic as well. I was called in the middle of the afternoon to a case in the casualty department of the district general hospital where I was working as a registrar in training with about five years’ experience. There was a woman—barely a woman; a girl, really, just out of her teens—who was lying virtually unconscious on a trolley in the emergency department. There was no relative with her, there was no history with her; there was no way of knowing what was the problem.
When I examined her very quickly, I noticed that her breasts were somewhat active and her abdomen was distended, and it became likely that she might have a pregnancy but of course there was no way of verifying that. There would not be time to do a test because this woman was lapsing into unconsciousness; indeed, as I was examining her, she became unconscious and her blood pressure dropped to unrecordable levels. I put her on a trolley and ran down to the operating theatre with it. I had asked them to call an anaesthetist to help me. When the anaesthetist arrived, who was a much more senior doctor than I, he refused to have anything to do with the treatment of this patient. He was not prepared to consider anaesthesia for this woman because he felt that that would not be appropriate for somebody who was already unconscious.
I do not say this out of any sense of pride or because I am being all-powerful but this is simply how one acts in an emergency. Without scrubbing up—with unclean hands, simply with gloves on—I took a knife and opened her abdomen briskly and tied off the bleeding point. It was an ectopic pregnancy and once we had removed the bleeding point her blood pressure immediately became recordable. That woman left hospital seven days after the procedure.
Had we gone through any of the procedures that are described in the Bill, I have absolutely no doubt that that unmarried 21 year-old girl would have died there on the table, and I would have been haunted by that had I not innovated in a way that was appropriate. It was only when the abdomen was open and the blood was welling out that my anaesthetist put a tube down her throat and assisted me with the anaesthesia. He was not frightened of litigation; he just thought that the patient was going to die.
In Amendment 17 I have delineated a few of the examples in medical practice where there is a real case for not innovating. I could argue—I notice the noble Lord, Lord Kakkar, is in his place and I hope he will agree with me—that every single one of your Lordships in this Chamber will have different anatomical variants in your abdomen. For example, if you are undergoing a hernia operation, the skill of the surgeon in trying to decide what the variant might be is something that he needs to tackle immediately and without consent of either an ethics committee or a group of doctors who might give him permission to do so. It is a nonsense to suggest that a surgeon needs to do that sort of thing in the process of innovating in surgical care. That is also true for neonatal care, where of course we do not have very good chances sometimes of deciding when a very small baby is on the point of death. There are many other examples. I would just argue that there is one rather exceptional case, which I have alluded to, which is in reproductive medicine.
In my view, that is a different situation. The risk is that if we encourage innovation, as we are inclined to do and as is happening in private practice at the moment for quite large fees, there is a real risk in the long term. For example, this week two companies have offered to freeze the eggs of their employees to try to delay their childbearing. It sounds a very humanitarian thing. It is not, it is a purely business proposition. What they are doing, of course, is trying to manipulate their female employees by doing this. But the doctors who are prepared to charge substantial sums of money for this freezing have not considered the real success rate that even young women who freeze their eggs have. In the United Kingdom, around 7% of patients who have had their eggs replaced actually have a pregnancy, and we do not even know how many of those pregnancies go on.
During that treatment, there are different ways of freezing eggs which are innovative, which have not been properly tested and which may, for all we know, have epigenetic effects 50 years on, when there may be a risk of high blood pressure, heart disease, osteoporosis or dementia. Indeed, we now know from some animal experiments that there are genuine incursions into the human embryo and the human egg, which in animals certainly cause very interesting but rather alarming changes in the central nervous system as a result of what is happening innovatively in humans. Of course, we cannot prove it in humans because we have to wait for a long time. I argue that Amendment 17 is essential but I suspect that more aspects of medicine will need to be covered in the Bill.
I support completely the amendment of the noble Lord, Lord Turnberg, who started the debate this morning. If he decides to press that amendment, I will certainly join him in a vote. The problem I will have, of course, is that part of that amendment, and certainly some of the implications of it, conflict with my Amendment 30, which argues that we should have clinical ethics committees. In my view, there is a strong reason to do that. I know that the Minister is very unlikely to accede to that request but there is a real issue about having better supervision of clinical treatments. We have research ethics committees but they are totally different. They do not cover routine practice. It is not a matter of simply leaving it to the General Medical Council. That is really not adequate. It needs to be dealt with locally and by the people who are concerned with the particular population with which they are involved.
I do not intend to go on at great length about the amendments in detail but there is no question that we will need to come back to some of them; others we may even wish to divide the House on this morning. But for the moment, I think I have said enough about those amendments.
Baroness Masham of Ilton (CB)
My Lords, my Amendments 14, 18 and 34, on safeguarding, are in this group.
Since the previous stage of the Bill, the deadly Ebola infection in Africa has hit the headlines and the need for fast-track innovative medicines and vaccines has become vital, as has the need for countries to come together to help support and educate suffering populations. In addition, last Tuesday the “Panorama” programme showed the innovative research being done on the spinal cord to enable paralysed people to walk. It is encouraging to see experts across countries working together.
Lord Cormack (Con)
My Lords, my noble friend Lady Gardner is right to talk about hope. It has been said that the real poor of the 21st century are those without hope, but there is a worse condition and that is to have false hopes. There was a very moving article earlier this week in the Times by Melanie Reid, writing from her wheelchair. Those of us who read her columns from time to time can only admire her courage, resilience and sense of reality. She was writing in the context of the gentleman in Poland who has been given some form of locomotion as a result of brave, innovative surgery.
We are all very conscious of the background to today’s debate, which is different from that to the Second Reading, because, since then, we have had, as has already been mentioned, the Ebola outbreak and the need for untried and untested treatments because they are the only things that might conceivably offer some hope. We have also had the extraordinary affair of the young boy taken to Prague for treatment that he was not apparently able to have in Southampton, and we had the grotesque spectacle of his parents being put in jail. It was the most dreadful story.
Those remarks are merely in preface because I strongly support the aims and objectives of my noble friend. He has done this House a service in bringing this Bill forward, but he has done more than that, because since the Second Reading, he has clearly listened. He has had long conversations with Sir Bruce Keogh, the Secretary of State and others, and has striven to make his Bill much better than it was at Second Reading. We are all very much in his debt for that.
I readily acknowledge that we have heard some powerful speeches today from people who truly know what they are talking about. I readily concede that this Bill is not perfect now. I believe that if we are to legislate on this front we need to get the best possible Bill to become an Act of Parliament and speed must not be the only criterion we take into account when we are legislating on such a complex issue.
It was very moving to hear what the noble Lord, Lord Winston, said about some of his own experiences. The account given by the noble Lord, Lord Turnberg, of the surgeon at 30,000 feet also brought home to us how incumbent it is upon those with medical and scientific knowledge to be able to react quickly. The whole purpose of science and medicine is to innovate, otherwise people are merely being repetitious, and if you are merely repetitious then you cannot make true progress.
I think that there is a way forward on the legislative front this morning. I hope that we can today accept the amendments that the noble Lord, Lord Saatchi, has thoughtfully and helpfully tabled, and I believe that there should be another stage, a Report stage, where in the light of the amended and improved Bill, people such as the noble Lord, Lord Winston, whom I admire greatly, and the noble Lord, Lord Turnberg, who has done so much himself, can sit down with the noble Lord, Lord Saatchi, and further improve the Bill, so that when it goes to another place it has the benefit of that vast reservoir of medical talent and experience which is unique to this Chamber.
If ever anything justified the existence of this Chamber, it is a debate such as we are having this morning, where people who have really achieved great things in their chosen field are able to bring the benefits of their experience to our counsels.
I hope that this morning we can accept the amendments of the noble Lord, Lord Saatchi, and that he will then consult the noble Lords, Lord Winston, Lord Turnberg, and others, so that when we have further amendments on Report, we can make the Bill as foolproof and comprehensive as possible. It can then go to another place, where I hope that they can expedite its progress to the statute book.
Lord Winston
My Lords, perhaps I may intervene briefly before the noble Lord, Lord Cormack, sits down. He refers to the Ebola virus and to proton beam or carbon beam therapy—I am not sure which it was—and the boy who eventually went to Prague, I think it was. In the case of carbon beam or proton beam therapy, there is extensive medical literature about the treatment, so it is not innovative in the context of the Bill. I suggest to the noble Lord that with regard to the Ebola virus, although a very experimental vaccine has been given that has not been tested, there has been extensive discussion in all sorts of circles, including the New England Journal of Medicine, which is one of the leading journals in the world of medical practice, of whether such plasmas or vaccines should be given. That is fundamentally different from the Bill. I thought that the subject of Ebola might well come up, and I just wanted to make it clear that that threat is a very different issue and would be outside the scope of the Medical Innovation Bill.
Lord Cormack
As that was meant to be an intervention, I suppose that I had better respond. I was merely mentioning things that had happened since Second Reading; I did not begin to suggest that they were relevant to the Bill. I mentioned them by way of background, but of course I take the graciously worded rebuke and entirely accept what the noble Lord, Lord Winston, just said about the scientific background to both those examples.
Lord Winston
Does my noble friend agree that one of his amendments tends to limit the Bill almost entirely to cancer treatment? There is a problem even there, however, because, as the noble Baroness, Lady O’Neill, said, surgery is an important part of cancer treatment. It is absolutely certain—I am not a cancer surgeon but I have watched many cancer operations, and perhaps other surgeons in the Chamber will support me on this—that cancer surgery is often the most innovative surgery, and you cannot possibly take a decision with the sorts of permissions that are usually required beforehand, because you do not know exactly what you are going to encounter. There is a problem there with the structure of the Bill as it presently stands.
Lord Turnberg
I accept entirely what my noble friend has said. The surgical aspects of the Bill are quite tricky.
Lord Winston
“( ) For the purposes of this Act, “innovation in medical treatment” means—
(a) the use of a medical procedure, treatment, therapy, device or instrument which has not been subjected to a randomised clinical trial or equivalent clinical validation, or for which there is no published evidence of its risks or benefits in peer-review medical journals;(b) the prescription of a drug which has not been licensed by the UK Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency;(c) the prescription of a licensed drug for a treatment, condition or therapy not recommended by the manufacturer; or(d) the use of a device or instrument which has not been regulated under the Medical Devices Regulations 2002 (S.I. 2002/618) for the purpose of that particular treatment.”
Lord Winston
My Lords, one issue that crops up again and again in this Bill is that we have not defined what is meant by innovation. This amendment tries to detail where something would be innovative—for example, a drug that has not been recommended by the manufacturer or a device or instrument that might be used in the course of infiltrating a patient’s body in some way. It may be a telescope or a plastic tube, or any therapy, device or instrument that has not been subjected to randomised clinical trials or published in a peer review journal. I have probably said enough about this amendment. It is very clear that, although the Minister says that we are trying to complicate the Bill unnecessarily, I think that sometimes the Bill needs more complication—it is not that simple—and certainly in my view the definitions of innovation are essential, because that is what the Bill is about.
Lord Kakkar
My Lords, I have some concerns about the wording of Amendment 6. Is it intended, for instance, to restrict the use of an agent or intervention that has been tested in a completely different situation—there may be some peer-review publication or some clinical validation in a completely different situation—but where it is proposed to use the treatment for another condition? One will recall that Gleevec was an agent developed principally for the management of patients with chronic myeloid leukaemia; it was an interesting biological compound that targeted a specific mutation in a signalling pathway in cells in that form of leukaemia. Many years later, it was noticed that that signalling pathway mutation was also seen in a particularly rare form of tumour, a gastrointestinal stromal tumour. Those who were innovating decided to use the drug because the genetic mutation appeared to be the same for treating that particular type of tumour to great effect. Would the description of innovation in the amendment have prevented that happening?
Proposed new paragraph (d) of the amendment deals with the question of devices or instruments. What happens if they have been developed and regulated for a particular intervention, and then an innovator decides to use them for a completely different condition? They will have been made available for regulated use but not for the condition in question. Would this amendment therefore restrict that type of innovation?
Lord Winston
I do not think that it restricts anything at all but actually makes the Bill of the noble Lord, Lord Saatchi, workable. We need some kind of definition of what an innovation is. That is all the amendment tries to achieve. It is not in any way restrictive. Of course, if one decides to put a plastic tube that is normally used to infiltrate the trachea into another organ, this amendment will permit that to happen, when currently it would not be allowed.
Lord Giddens
My Lords, the noble Lord, Lord Saatchi, knows that I support the thrust of the Bill but there are issues around some of these amendments that the noble Lord might at least listen to.
As I have mentioned previously, one of the core things about this legislation, given its sensitive nature, is that we have to comb through it all the time for possible perverse consequences. At the risk of sounding like sociology 101, unintended consequences are different from perverse consequences. Unintended consequences can be good or bad; perverse consequences undermine good intentions and reach the opposite result of what an individual needs to achieve. For example, strong rent controls were introduced in New York City to help poor people; in fact, they adversely affected them because they could not find places to live. The noble Lord says that the Bill is crystal clear in its intent, but that is not enough because there is a massive difference between intent and consequence. I therefore feel that as a general principle we should comb through the whole Bill to try to spot possible perverse consequences.
On the whole, with the reservations that have been noted, I support Amendment 6 because it might help to block off some of those reservations. We surely must know what innovation actually means in the context of clinical practice. Without such specification, one can see that various perverse consequences could occur. What would happen, for example, if a doctor was accused in court of failing to innovate because he or she did not try some eccentric form of treatment that was available? One could block off that perverse consequence by specifying, in the way that Amendment 6 tries to do, what actually counts as innovation.
I feel strongly that as the Bill proceeds through Parliament we must tighten every loophole that could lead to a situation in which, to some degree, the Bill undermines what it is actually supposed to achieve—helping vulnerable patients in a situation in which they are often desperate by bringing innovations to them that they would not have had available before. However, I fear that some of those things could happen if one was not aware of the minefield of perverse consequences. If we do not examine it all carefully, there could be consequences that, to some degree, undermine the purest of intentions with which the legislation is introduced.
Lord Winston
My Lords, I thank noble Lords for their interventions on this amendment. In view of what has been said, I think we need to take these ideas away and think about them and consider the points made by the noble Lord, Lord Kakkar, and others. I thank the noble Lord, Lord Saatchi, for his courtesy in his reply to my amendment. For the moment, I beg leave to withdraw the amendment.
Earl Howe
My Lords, the Government support these two amendments, which ensure that the Bolam test will remain unaffected by the Bill. In practice, this will mean that it is for the innovating doctor to decide whether to take the steps set out under the Bill or to rely on the existing Bolam test. In other words, there would be no requirement for doctors to follow the Bill when innovating.
The amendments clarify that, separate to the existing Bolam test which is applied by the courts, the Bill provides doctors with an alternative option for showing that they are acting or have acted responsibly. Furthermore, subsection (2)(b) of the proposed new clause provides that doctors are not negligent, and thus will not be judged adversely if their actions are later challenged, merely because they have not followed the Bill.
My noble friend Lord Kirkwood asked how the proposed new clause affects how a regulator approaches a complaint or fitness-to-practise procedures. This Bill addresses clinical negligence law and how the courts will assess these cases, not how the regulators will process fitness-to-practise cases.
The noble Baroness, Lady Wheeler, asked whether the Bill was necessary. The Department of Health’s consultation on the Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. There will also be many doctors who are not afraid to innovate and for whom litigation is not a material concern. Those doctors can continue to act as they have done previously and rely on the existing law of clinical negligence, or, as I have explained, they may choose to take advantage of the Bill instead.
I hope that noble Lords will accept these two amendments, which give flexibility and choice to doctors who want to innovate.
Lord Winston
There is something troubling me here. Let us say that somebody in an emergency or other situation does not have a chance to go through the required tests stipulated by the Bill, consulting other individuals who may be confident about or more experienced in that position. I still do not understand in the context of what the Minister has just said where that individual stands in innovating without those permissions. Is that still part of the Bill? How does that work? Is there a risk of that person being irresponsible in view of his not fulfilling what is required in the Bill when he is innovating?
Earl Howe
I completely agree with the noble and learned Lord’s analysis of the situation. I hope that that has been helpful to the noble Lord, Lord Winston. Earlier, the noble Lord cited an example where a doctor was confronted by an emergency requiring innovative practice. Whether the doctor was acting responsibly or not, and the consequences, will depend on a number of factors. It will depend on the extent to which the doctor is confident in his or her judgment, based on experience in previous clinical practice and can, if necessary, show to a court that what he or she did was responsible and, at least in intent, in the best interests of the patient.
The noble Lord asked whether there was a risk of a doctor being found to be irresponsible in some emergency situations where innovative treatment is practised. Yes, there would be a risk if the process outlined in the Bill were not followed—but that situation obtains today.
Lord Winston
Both the Royal College of Surgeons of Edinburgh, of which I am a fellow, and the Royal College of Surgeons in London, absolutely support the idea that surgery should be excluded from the Bill for this very reason: they consider that there might be situations where the courts become unnecessarily involved. That involves extra expenses to the health service because of our current concern with litigation. As the noble Earl well knows, in obstetrics, for example, litigation already accounts for a huge proportion of the expenses devoted to maternal care. There are considerable knock-on effects where litigation may be started because of lack of clarity. It is possible that I am being stupid—I recognise that I am not nearly as intelligent as the noble and learned Lord, Lord Woolf—and I will have to go away to think about this, but there seems to me to be a misconstruction here which is puzzling and, I think, worrying.
Lord Saatchi
I hope that this may help my noble friend Lord Kirkwood. What we have just heard from the former Lord Chief Justice and the Minister is completely clear to me. I will try to explain it in this way: if the doctor feels completely confident that the innovation he is about to attempt will be approved when the Bolam test is applied in a subsequent trial, he will go forward with his innovation. If a trial then takes place, he either will or will not be proved right when the test is applied—that is, if he departed from standard procedure and decided to do it on the basis of his confidence that the Bolam test would make him innocent of negligence.
However, as we all know—this is fundamental to the Bill—if the doctor is obliged to speculate in advance about what might or might not happen in a trial, that raises a very high degree of uncertainty. If it is possible for a doctor to move the Bolam test forward and comply with it in advance, which is what would happen as a result of the Bill becoming an Act of Parliament, that would enable the doctor to move forward with an innovation without the fear that a subsequent trial will find him guilty. I therefore say to my noble friend Lord Kirkwood that what we have here in simple, plain language, is that the Bill is giving the doctor an option if he wants to be certain before he goes ahead with an innovation. It is not a requirement that he does that. If he is confident of the result of a subsequent application of the Bolam test, he does not need the Bill at all. It is a fundamental benefit of the Bill that it gives that option, which I think is a very simple one.