Medical Innovation Bill [HL]

Debate between Lord Winston and Baroness Masham of Ilton

Friday 24th October 2014 Lords Chamber

[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.