Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 1180 - 1199)

WEDNESDAY 8 DECEMBER 2004

DR RICHARD KENNEDY, PROFESSOR ALLAN TEMPLETON AND PROFESSOR LESLEY REGAN

  Q1180  Chairman: Lesley, what is your view, as a clinical director?

  Professor Regan: In response to Dr Iddon's comment about why the UK is halfway down that list, I think it is very important to emphasise that this is inherently linked to the way the data is presented and collected. I have not seen the table but to base assessment of a clinic's, if you like, achievements on embryo transplant rates I think is not helpful at all; it should be on live baby rates. As Allan was pointing out, there are concerns regarding multiple embryo transfers and multiple pregnancies; there is enormous attrition in terms of miscarriage and very early, pre-term delivery and serious neurological consequences in triplet pregnancies.

  Q1181  Chairman: If we had a table of live baby rates, where would the UK be?

  Professor Regan: I would have to look at the figures, but I think significantly higher. If you talk to colleagues in the United States where embryo transfers can be three and upwards, there are enormous problems in ante-natal pregnancy care and enormous attrition of pregnancies that have been conceived as a result of assisted reproductive technologies with enormous consequences for the health care resources that are needed to look after those babies even if they survive, as they very often suffer from significant neurological disabilities, and that is even before we have got to the point of the trauma of the very vulnerable couples who undergo treatment.

  Q1182  Dr Turner: Previous witnesses have suggested to us that "the regulatory framework needs to move forward to deal with the unexpected frontiers"—to come back to this discussion we were having earlier, Dr Kennedy. Who do you think should make the decision on what is a standard treatment or a treatment that is pushing at the frontiers?

  Dr Kennedy: In-vitro fertilisation, for the vast majority of patients in the United Kingdom is a very standardised treatment now; 1 to 2% of all children born have resulted from this treatment. The recently published NICE (National Institute for Clinical Excellence) guidelines did allude to the sorts of areas for which there is no evidence for efficacy, and a number of areas of practice—for example, assisted hatching would be one—for which there is no published evidence but yet is practised fairly widely and would be one area that research should look at and prove conclusively, once and for all, whether it is useful or not. There is clearly the mechanism and the framework within the United Kingdom to establish research studies for unproven technologies or new technologies, and that should be the framework that should apply to new developments in this area.

  Q1183  Dr Turner: At the moment, the HFEA has to rule on proposals for new treatments for research. Do you think this is satisfactory? Do you think it should be done by a separate body from the day-to-day regulatory body and, if so, how would you like to see it set up?

  Professor Templeton: The approval of research, I think, has been a reasonably satisfactory process and has permitted embryo research within this country. I think the rate-limiting factors, to a great extent, have been just the nature of the treatment, the lack of embryos to research on and the funding to do it. Within the HFEA framework the capacity to do the research has not been inhibited by the legislation, in my view. Where there is a problem has been where research moves into clinical practice and where clinical practice then is still in the realm of research. A good example is cytoplasmic transfer, which means taking a bit from a healthy egg and putting it into a so-called unhealthy egg. That was actually carried out quite extensively in several clinics, although not many, in the US without any form of regulation, without evidence of safety and without any evidence of efficacy and, in my view, was something that should have been regulated at that stage prior to being offered to patients who, by and large, were paying for treatment that was both unsafe and inefficacious. However, that is the nature of medicine and the way it is delivered in the United States, to a great extent. I think there needs to be, alongside the research processes, processes for clinical trials and here they should really be not on the inhibitory side but encouraging clinical trials. Last week, of course, the MRC/HFEA report very much suggested that we do need to get going with multi-centred clinical trials in this country. So I think that the mechanism can be set up in the same way as for research but more encouraging for clinical trials.

  Q1184  Dr Turner: Do you think it would be useful to use local research ethics committees for the purpose of judging embryo research proposals, provided they were suitably beefed up, or do you think the public would distrust that?

  Professor Templeton: My own view is that provided the ethics committee knows what is permitted within the legislation it is perfectly appropriate for the local ethics committee to proceed in the same way they would for any other clinical trial, or research.

  Q1185  Paul Farrelly: I just wanted to move on to the issue of the welfare of the child. This is really, given the evidence, a question for the two professors but, please, Dr Kennedy, if you want to come in. The Royal College says that the current welfare of the child provisions should be replaced by guidance to ensure that the child is not born into a family where there are reasons to believe it will be at risk. How do you envisage that working in practice?

  Professor Templeton: It is good medical practice. I am talking here about a patient who needs IVF or donor insemination, or whatever, within the law—therefore it is the welfare of the child—but I may well be seeing another patient who is requesting some other form of fertility treatment, and it is good medical practice to ensure that the treatment we are offering is appropriate to those patients' conditions. I do not actually see that there is a need for specific welfare of the child issues within any act; it is good medical practice. The welfare of the child recommendations came about because of concerns, at that time, of single women having children through assisted reproduction. We actually agreed it is without brackets "the need for a father". That became hugely distorted into an attempt to try and pick and choose which patients were appropriate to be treated on the basis of the welfare of the child, and the outcome of the treatment, and it has been one of the major distractions. I said there were one or two rough edges and irritations, and that has been one of them. It has been a distortion of clinical practice; it has been absolutely beyond any effect at all in terms of trying to enhance the welfare of the child. All the time it was going on, of course, we were having multiple births—triplet births and so on—around the country, and if you want to talk about the welfare of the child start talking about 28-weekers being born in triplet births. So it was a complete distortion of HFEA priorities.

  Q1186  Paul Farrelly: That is the first part of the question. The second part is how do you see guidance working?

  Professor Templeton: It is good medical practice. I do not think you need guidance. Why would you need guidance to try and make a decision? It is the same issue as whether you treat an HIV-positive patient or you have two patients who happen to be heroin addicts and whether you should treat those within your clinic. That is the discussion you have. You cannot generalise; it is good medical practice to take a decision about the appropriateness of treatment in any given circumstance.

  Q1187  Paul Farrelly: So someone, for example, who was on the Home Office register of (let us put sexual offenders to one side) violent offenders would be a relevant consideration?

  Professor Templeton: It certainly would be a relevant consideration, in my view. Of course, the responsibility is to try and find out if, indeed, that history exists in a particular circumstance.

  Q1188  Dr Harris: I would like to explore this good medical practice. I understand what you say about the welfare of the child, and thank you for being so clear, but I would like to explore the difference (I was not here earlier but I read your evidence) in approach between infertile and fertile couples in respect of allowing them to breed, from an ethical point of view. What you are saying is it is good medical practice for a doctor to come along and say, "We are not going to let you have a child, though we are not going to sterilise you if you happen not to be infertile, but we are going to use our subjective judgment" (and it may not be someone as progressive and liberal-minded as you; it might be some old, crusty gynaecology professor—I understand some still exist—

  Professor Templeton: There are a few!

  Q1189  Dr Harris: Is that good medical practice or is that just the application of prejudice in a sort of paternalistic way, not even to the patient in front of you but to some future person?

  Professor Templeton: The application of prejudice in a paternalistic way is not good medical practice.

  Chairman: Did you miss that in your training?

  Q1190  Dr Harris: You have just said there are HIV-positive issues, for example, or heroin addicts. Let us take a doctor who is a heroin addict, and there are many around. What you are saying is that there are two options: to say, "We are going to treat you as a patient; we are going to give you education, information and offer you treatment, and urge you to take that treatment. You have these questions about your fertility, we are not going to stop you from trying to conceive naturally", but instead of taking the approach "I am going to inform social services because there are issues for the child" you are going to make the decision to deny treatment to that person. That is the example you used. I would like to ask Dr Kennedy as well for his view.

  Professor Templeton: I might. Having discussed that, a good medical practice view, with everybody who could possibly be involved in such a decision you would, particularly, obviously, want to discuss it with the patients. It may be that, from time to time, your view would be that it would be inappropriate from the point of view of the child to treat that couple. It may be. It obviously is a difficult area, and I do not think it is going to be helped by guidelines or legislation, because they cannot legislate or produce guidelines for every clinical situation; there are principles which are laid down in good medical practice, which I would follow in reaching such a decision. Because this patient is infertile and seeking assisted reproduction treatment does not make the approach any different from, perhaps, seeing an ante-natal patient who happens to be a heroin addict and alerting the services and discussing her management with those who can best support that management. It is exactly the same decision, exactly the same process.

  Dr Kennedy: Yes, I agree with that. I do not think you need to regulate for it specifically. As a doctor, when you discuss with the patient, in the consultation process, the wider implications of whatever it is you are advising or about to undertake for that patient, those wider implications will include the consequences of the treatment, the child that may be born and the background of the person who is seeking treatment. This is part of the normal consultation process. If that involves accessing information from social services or asking the patient if we can access information then so be it, you do so. If it requires additional help to make that decision, then you invoke that additional help, but it does not need regulation to ensure that you conduct that practice. The other issue here is the bureaucratic process which is currently applied in the implementation of the welfare of the child assessment.

  Q1191  Dr Harris: We have heard plenty of evidence on that. So what you are saying is that you would be happy for some of your colleagues to deny treatment to a man who is a heroin addict where the mother was not, and for some of your colleagues not to (because they might think that) but to notify social services around an at-risk assessment, and you would be happy with two different approaches being taken by different people with a different background and different medical perspective, because you do not support guidelines, and you think as long as they are acting in the interests of society—

  Dr Kennedy: I did not say we did not support guidelines. There have to be guidelines to undertake good medical practice—of course there have to be guidelines. That would require you to take account of certain issues and certain considerations before you make your decision about offering treatment.[1]

  Professor Templeton: You make the assumption, if I may, that the guidelines would actually prevent what you have just said, and there is no evidence to suggest that you might not treat appropriately one patient quite differently from another patient in that patient's circumstances—something the guidelines could not even begin to help you with.

  Q1192  Dr Harris: If there was a human rights claim, for example, by a lesbian couple, then guidelines, I would imagine, would swiftly follow to say it is unlawful, if there had been a successful claim, as people think there would be if there was a claim. So some of your colleagues to whom we have spoken who refuse on their own moral grounds to treat lesbian couples would be out-with their terms—

  Professor Templeton: It is just the same as some doctors refusing to do abortions.

  Q1193  Dr Harris: I am not convinced that there would be a conscience option when there is a human rights claim that you are suffering discrimination and the NHS says, "We will not discriminate—"

  Professor Templeton: You have a human rights issue; if you are doing something against your conscience then the proper way of dealing with that is to pass it to another doctor. That, again, is good medical practice. That is enshrined in that code.

  Q1194  Dr Harris: One more point here. Is an alternative to this welfare of the child provision and, indeed, some guidelines about good medical practice to say that we are not going to discriminate against the infertile, as we do in practice, effectively, by denying them reproductive freedom, for whatever reason, but we are going to say that—

  Professor Templeton: Or, more particularly, denying them funded treatment.

  Q1195  Dr Harris: So denying the poor infertile from access to reproductive freedom (which I think adds to the strength of my argument because there is an equity issue as well as a human rights issue) and, instead, say "Look, at least we now know what is going on and we have the option of ensuring that social services are there at the birth so they can make a risk assessment and, if necessary, intervene, but we are not going to do it in a prior way." Do you think that is a reasonable approach in cases where there is a history of domestic violence, for example, or there is a drug addiction issue? Is that an alternative approach? Do you see merits in that?

  Professor Templeton: Do you mean that the guidelines would say that, or do you mean—?

  Q1196  Dr Harris: The system would be that there would be a presumption of non-discrimination against the infertile, because if they are fertile and there is domestic violence or heroin addiction they can breed, and you do not know there is the risk, whereas here, at least, you know there is the risk and you can bring in social services at the birth.

  Professor Templeton: I would be very happy if that steer, which is all that we are saying here, was enshrined in the legislation, yes.

  Q1197  Dr Harris: Finally, if the welfare of the child issue around multiple embryo transfer is so obvious why did it take so long?

  Professor Templeton: Do not ask me. I have been writing about it since 1995. The RCOG guideline in 1998 recommended two embryos, and the BFS guidelines at that time. It has taken until two years ago for the HFEA to catch up with what was recommended clinical practice. In Scandinavia now, in many clinics, 60% of the embryos are put back one at a time, with no apparent reduction, as that table that has just been passed round shows, in the overall pregnancy rates. So I think it is a big issue and I think we have to ask ourselves why it did not happen more quickly. Certainly the HTA could have made it happen more quickly but I think they were very concerned about legal challenges; they were very concerned that there was a society view out there that patients were willing to take the risk. That was quite erroneous, in my view but, nonetheless, is part of the reason for this slowness in their eventually making their pregnancy—

  Q1198  Dr Harris: I see Dr Kennedy nodding, for the record.

  Dr Kennedy: For the record.

  Q1199  Paul Farrelly: Has Professor Regan been nodding as well?

  Professor Regan: Yes, she has. I think it might be useful to add as well that one of the delays in introducing this legislation is that there has been an enormous drive from the private funding sector in the sense of what they have wanted. Whether that is in the remit of this Committee or not, I think it is important to look at this issue and keep that context in mind.


1   Note by the witness: My views about the legislation governing the Welfare of the Child and of the British Fertility Society are very similar to those of Allan Templeton in that we believe its assessment is enshrined in good medical practice. It is helpful for guidelines to draw attention to its need and how clinics might construct protocols for its assessment, however it does not require legislation. Our major concern is to eliminate the bureaucracy that this element of the legislation gives rise to. Back


 
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