Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 1060 - 1079)



  Q1060  Dr Iddon: It sounds, Professor Peckham, as if you are saying that we need a regulatory body but there is something wrong with the HFEA so can I tease out of you how you perhaps would improve the regulatory body, if it were an expansion or a development of the HFEA or a completely new organisation, and I would ask the other witnesses to throw their ideas in too.

  Professor Peckham: I am probably not the one to say how that should be done but I think that the science underpinning might mean that you need more careful regulation of the early assessment of some of the new technologies so that you might license for limited use for a duration of time while information is accrued, and that you get the proper evaluation before it is more widely used across clinics. I think probably Professor Leese would be in a better position to answer that.

  Professor Leese: I would agree. We were able to give either a red, amber or green light to the new advances but we were not really then able to follow them through as they were being practised in the clinics, and clinics do things in different ways. If we had a more systematic approach to following through the recommendations that HFEA made you could do a lot of research, but you would need input of probably a different mix of researchers who were experienced in doing randomised studies and trials, etc, so we would recommend something and attempt to see it was followed through in the clinic but we were not a research body, and could not dictate the research they should do, but there is a lot of different practice going on out there and if it was managed more effectively we could get a lot of data on how these different procedures work.

  Q1061  Dr Iddon: Do you think the HFEA are trying to regulate things that should have been passed on to other bodies like the other regulatory medical organisations, for example, IVF? We have had the view presented to us that IVF is such routine medical practice that really the HFEA should hand it on to the other regulatory organisations and concentrate on the newer technologies.

  Professor Leese: I do not feel very strongly about this. As long as the system is in place I am not a what-is-the-best-way-to-regulate type of person. I am a great believer in getting the best people that you can get round the table and coming to a decision. As to how that is, as it were, systemised or put into practice I do not have a strong view on. The HFEA when I was on it did its best with limited information, and that I thought worked quite well. I do not feel strongly whether this part of its function should be given to someone else.

  Professor Edwards: Could I make a comment? I think the introduction of ICSI is an example of what you may be searching for. That was discovered by accident and within three months it was crossing the world, not only Britain. I was amazed that it worked—I still am but it does work. There was never any foresight in what might happen to that. The second example which may be more relevant is that some of our American friends—

  Q1062  Dr Iddon: Could I just interrupt you and ask do you think the HFEA held back the development of ICSI?

  Professor Edwards: I think it probably came in just before the ICSI was formed.

  Professor Leese: No, it was not. 1993.

  Professor Edwards: ICSI was 1991, I think.

  Professor Leese: I felt they could not have done. It worked. Infertile men were being able to have babies and the floodgates were opened. It would have been inconceivable to stop it. In an ideal world you would; you would have gone back to animal studies, work on surplus human embryos, work on clinical trials. Ten years later, the green light. It is now 50% of all practice in the clinics. It would have been impossible on emotional, pragmatic, and practical grounds to stop it.

  Q1063  Chairman: Legal grounds as well?

  Professor Leese: Maybe.

  Professor Edwards: The group that has done more to follow up ICSI is the Belgian group, headed by Andre van Steirtighem and Paul Devroey, that started it and I would say if you wanted an example of a clinic that is incredibly responsible, that is Professors van Steirtighem and Paul Devroey in Brussels, where their follow-up studies have been astonishing, and I take my hat off to them. But also to your point, a technique came in five days ago of seeing if you could donate ovaplasm from a good egg to a poor egg. It ran into a problem with mitochondria. In relation to the question you asked, the FDA in the States called it in. Now, they have the power to call researchers in. I know that many of my colleagues were very apprehensive about what might happen in the committee. In the end the FDA did a thorough study; decided there was no adverse evidence; and said, "Carry on with caution or report back". I think that is what you are getting at actually, and the model I would strongly suggest you go to is the American FDA, the Federal Drug Agency, which is responsible for all drugs but now responsible for all new techniques, and not only drugs, so I think it is the organisation you are looking at.

  Q1064  Dr Iddon: What I am really getting at is a simply yes or no. Do any of our witnesses feel that the HFEA have held back, first of all, research and then, secondly, the translation of that research into a medical practice?

  Professor Edwards: No.

  Professor Leese: It has always been one of the pillars on which it has worked, the HFEA, the need to promote good research, to get a good evidence base as with any area of medicine, along with welfare of the child, respect for the embryo, for example. The need to promote research has always been there and as someone who has had a research licence, even a voluntary licence prior to the Act, I have had firm management of the licence and rigorous application but I have always been encouraged to do research.

  Professor Edwards: Could I amplify that comment? In two years before the HFEA developed as a scientist I had to bring a libel action in the High Court in London against the BMA, BBC and several newspapers. We were right in the forefront of ethics. If you argued you went to law, there was nothing else. If you made a decision and somebody did not like it, they were able to sue you. The HFEA ended all that and I would say since then that we in Britain have been very lucky indeed, and I really want to state that, because when I go abroad the admiration of the HFEA is unbounded. Many countries have copied it, copied us, yet if the HFEA makes a decision, in my field—I do not know if it goes to the public at large—the decision goes around the world. That is what we have created in Britain. I think we should be very proud of it but I do agree with you that you may need an FDA as well that takes over the research once it is under way. I think I would agree with you on that one. But the HFEA to me has been fantastic. We have disagreed with them. We disagreed on the second case of the designer baby. There was a child's life at stake—to me that is number one, and it did not seem to be number one with the HFEA, but there may be a reason for it, and I know they gave reasons at the time. So that is where we stand. The HFEA I think has been wonderful.

  Q1065  Dr Harris: What was the reason they gave at the time?

  Professor Edwards: I have to think back. The case was not a definite genetic case. It may have had environmental effects.

  Q1066  Dr Harris: Were you on the HFEA at the time?

  Professor Leese: I was on then. They were concerned about the risks of biopsy and the super-ovulation on the woman, and that until there was long term or better evidence for the safety of the biopsy technique that would be required they should delay on this one. I think eventually they got it right, but it was a kind of precaution when it first came to the authority, if I recall.

  Q1067  Dr Harris: Yes. Now, I would like to ask the panel, on that issue, because we have just been talking about the use of evidence by the HFEA, in the Whittaker case, as you say, they say that they said that they were not going to allow the existing child to be treated in this way because of the risks of biopsy, and then they changed their minds on a later case. Was that because, in your view, the science had changed? That there was a study published in the interim that showed that the biopsy was safe?

  Professor Leese: I think I came off the authority at that point—which is not a very good excuse. I think there was a general rethink and maybe the climate changed as well. You would really have to ask the people who made the subsequent decision. I think the prevailing culture had been "If we are not very happy, we will say no". I really believe that. We are desperate to help these couples but if we feel there is a problem it is beholden on us to say no, and I think the first time round there was a lot of novelty to it.

  Q1068  Dr Harris: But the Whittaker child could have died, so some people argued you have to have a good reason to adopt a cautionary approach even though PGD had been going on for a while and there had been no—

  Professor Edwards: The risk of damage to an embryo by taking a cell off appears to be minor, if at all. The embryo is able to adjust. Secondly, the case that they made against going ahead was that they wanted clear-cut cases where there was a clear gene involved and not something else that may or may not happen. I cannot remember the situation that may or may not happen in this case but you will find it in the HFEA report.

  Q1069  Dr Harris: But they had a similar case where there was not a gene involved that they could select out?

  Professor Edwards: Yes. Now, when that same couple who had been declined because it was purely genetic went to the States, the case was done immediately by a group over there. So this ended happily but at the time I thought the HFEA made a mistake. If there is any risk to a child I think you go ahead. That is my own feeling.

  Q1070  Dr Harris: So to generalise, what is your view of the way the HFEA uses clinical evidence in supporting policy decisions? That is one example. Ending donor anonymity is another; the number of embryos transferred.

  Professor Edwards: Yes. If it was strictly clinical evidence in this question I would say they have very good advices. The scientists on the HFEA are no pushovers. They will judge on the evidence. It is usually the social side I think I disagree more on. In the case of Diane Blood, in the case of this DBA baby—but these are very rare cases. On the whole the HFEA handles the clinical evidence properly and the scientific evidence properly.

  Q1071  Dr Harris: Professor Peckham, do you agree?

  Professor Peckham: I think they have very good expert advice when making individual decisions and they are very science-aware but I think the climate changes and I think, as already mentioned, there are social factors that come into this, not just science.

  Q1072  Dr Harris: It has been well known, for example, that multiple embryo transfer gives a significant risk obviously of multiple births and that the outcomes there are poor, and other countries in Europe—Sweden, for example, is very clear about single embryo transfer, has higher success rates than we do per cycle I understand, although I know it is hard to compare like with like but in the ICSI data we have seen, so why did it take so long for there to be even the limits there have been in this country on multiple embryo transfer?

  Professor Edwards: Louise Brown was a single embryo transfer. When we started we did single embryo transfers for years because we thought the human embryo was the same as animal embryos. It turned out that only 15% of all human eggs will implant. We are in a disaster area here so you have to select the embryos, and we now know how to select them—just to find the 15%. So the single embryo transfer has been on the cards for a very long time. The Scandinavians advertised it but other people did it as well, I would say.

  Professor Leese: I think with hindsight the HFEA could probably have moved a bit quicker to lower the limit from three to two and I suspect there is no question eventually we will go to single embryo transfer. It is a matter of when that happens. I think they could perhaps have gone a bit quicker. There were some quite vociferous complaints from some clinics that this was going to reduce success rates, which of course it would do, but I think they could have moved a little bit quicker. But they are there now and I think they will go to single embryo transfers eventually.

  Professor Edwards: May I say I would not accept a criticism of the HFEA on this score because it came in slowly, as various nations moved towards it. Finland deserves a lot of credit here but it was on all our agenda. We wanted go to two and one embryo transfers, if we could. It became possible when we knew how to select the best embryos. Then it became possible. Now, that was the breakthrough, and that breakthrough started about 1990 or something like that. That is when it became clear you could transfer single embryos and get 50% pregnancy rates and that was the breakthrough. Without that you were forced to transfer two or three. There was no other way round it.

  Q1073  Dr Harris: Lastly in this area is my question about whether the HFEA or societies should restrict clinics from offering treatment and tests where the value and outcomes are still unclear. One example might be anuploidy screening where there is not a huge amount of evidence to suggest that it increases the chances of a live birth, but it is being offered by some clinics. Should we say "Wait, stop, let us trial it in some areas", or should we say "Let's just give information and allow patient to make the choice with their doctors"?

  Professor Edwards: I think you met Dr Verlinsky in the meeting. He has done now 5000 cases I think—well, maybe not that number but an immense numbers of chromosome analyses on embryos, and the group led by Jack Cohen and Santiago Munne must have done about the same. These are two American groups. We have done very few in comparison. Their data I think, and I have to agree it is recent, is getting very convincing indeed—that you reduce the number of abortions because you select out those who are going to abort. You choose the best embryos, so even some women of 42 have managed to have their pregnancies where before they may never have had them, because they only have one embryo in ten to transfer. This is the situation we are in, you see.

  Professor Leese: It has to be said, though, that there was a large study in Belgium which was the first really properly randomised study that showed no advantage so I think the jury is out on aneuploidy screening, and I think it rather picks up your question. It is very difficult to know what to do. HFEA license it in a few cases. I think it would lend itself to the sort of approach that Professor Peckham's committee are advocating where you follow the procedure much more rigorously once it has been started. I think HFEA would allow it and we would have reports back but in no way was this a systematic examination of this new technique, and I think that is where your work would come in really well.

  Q1074  Chairman: Very quickly, on the licensing process itself is there too much peer review in the licensing process, including the funders, and is the Freedom of Information Act going to make a difference too about information and the anonymity of reviewers and so on, and should the funders be encouraged to apply criteria set out by the HFEA before funding research projects? There are changes going on in licensing applications.

  Professor Leese: What was the last one again?

  Q1075  Chairman: When you fund something, should the criteria set out by the HFEA be picked up by the research funders as well, or should they just ignore them?

  Professor Leese: I think there needs to be a dialogue between bodies like the MRC and the HFEA because much of what we said obviously costs money to get the evidence base where if it were in better shape it would cost money. I think there is no question about that. But it still comes back to the HFEA not being a research body. That is not what it was set up for.

  Q1076  Chairman: You can see what I am driving at. There is too much of it going on. Why do they not get together and form one body?

  Professor Leese: The HFEA requested that your committee be formed.

  Professor Peckham: I think that showed great responsibility and I have heard nothing but good about the HFEA, particularly internationally. I think it showed responsibility to come to the MRC because of their concern that they wanted to ensure that the scientific evidence—

  Q1077  Chairman: Let me cut the cackle. Should the HFEA have a research function, do you think? You have investigated it. All the playing around, peer review to the right, to the left, for the licensing application—why do we not just give them the function and get on with it? If you trust them so much, if they are so damned good?

  Professor Leese: The HFEA were so good because they created a climate in which this could operate. I do not think they should be a research body.

  Q1078  Chairman: Why?

  Professor Peckham: You cannot do research in that sort of environment. You have to have the scientists working together; you have to have the back-up for research; you have to have the interdisciplinary groups—it has a totally different function. Legislation is quite different from a research activity.

  Q1079  Chairman: You can have sub-committees and sub-organisations?

  Professor Leese: I can see them putting up the projects for tender maybe and then you would have to have the MRC or even the department responding to the tenders and saying "This is the project I would seek to—

  Chairman: I do not think we have thought this out at all. There are too many people with fingers in the pie, I think. You may disagree but that is how I am reading things.

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