Children: Obesity

Lord Winston Excerpts

Tuesday 12th January 2016 Lords Chamber

[Baroness Walmsley]

My Lords—

[Lord Winston (Lab)]

My Lords, given that homo sapiens is a species that is programmed to eat carbohydrate and fat, what estimate have the Government made of how much childhood obesity is due to epigenetic factors rather than simply eating sugar and carbohydrate later on in life? Might this not be programming earlier in the generation perhaps as the result of previous generations’ environment? This is an essential point in understanding obesity.

[Lord Prior of Brampton]

The noble Lord makes an interesting point to which I cannot give an answer from the Dispatch Box. It is clear that epigenetic factors are important. It is not just about behaviour: rather, it is also the genes that we have inherited from our forebears and the fact that we have entirely different nutrition and an entirely different way of life today from that of 70,000 years ago. Would it be all right if I write to the noble Lord and explain that more fully?

Mesothelioma (Amendment) Bill [HL]

Lord Winston Excerpts

Friday 20th November 2015 Lords Chamber

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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

Friday 20th November 2015 Lords Chamber

[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

Monday 19th October 2015 Lords Chamber

[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

Wednesday 15th July 2015 Lords Chamber

[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

Monday 13th July 2015 Lords Chamber

[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

Tuesday 3rd March 2015 Lords Chamber

[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

Thursday 26th February 2015 Lords Chamber

[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

Tuesday 24th February 2015 Lords Chamber

[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 Winston]

Dangerous.

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

[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

Friday 23rd January 2015 Lords Chamber

Moved by

[Lord Winston]

1: Clause 1, page 1, line 10, at end insert “(for the purpose of ensuring that the proposed treatment would command the respect of a representative body of responsible medical opinion, having regard to the needs of patient safety).”

[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.

--- Later in debate ---

[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.

Amendment 1 withdrawn.

--- Later in debate ---

[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.

--- Later in debate ---

[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.