Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 1120 - 1139)



  Q1120  Dr Harris: We have been to Italy where we heard some fascinating exchanges. The Italian Health Minister told us that, in his opinion—and he is a doctor—far more work was needed on animal embryonic stem cells before there was any need or any point of work in humans. Is this a reasonable position and, if not, why not? Separately, the Vatican gave us a paper purporting to demonstrate, with references from scientific literature and they were very keen to stress that, that it was adult stem cells that showed all the signs of having therapeutic application and there was very little evidence that embryonic stem cells would be as good and therefore we really ought to press ahead with adult stem cell research which did not involve the use of embryos which is at least controversial in most jurisdictions. Is that wrong and, if so, why?

  Dr Lovell-Badge: First of all, there are at least two reasons for working with embryonic stem cells. One is to work towards therapies and the other is to use them as an experimental tool to gain understanding of diseases and other normal processes. We know that there are differences between mouse and human embryonic stem cells in the way they are grown, in their requirements and, in some respects, in their early differentiation. So, I think you need to study both. There are all sorts of things which are different between humans and mice and we could take an example being the frequency of chromosome abnormalities in early development. If you want to study that using embryonic stem cells, for example, to generate gametes from the cells and look at what is going wrong in meiosis, you cannot do that using mouse embryonic stem cells because mice do not have this really high frequency of abnormalities that human embryos do. That is one example.

  Q1121  Dr Harris: And in respect of the other issue, adult stem cells? There are scientific references on this paper.

  Dr Lovell-Badge: There are lots of examples where people are trying to take adult stem cells into the clinic. Not all of them but many of them are difficult. It is hard to get sufficient numbers of stem cells to treat people. It is hard to grow these stem cells; there are all sorts of problems. I am not saying that we should not be working on adult stem cells, I have never said that, we have to. However, we do not know which is best, whether it is potentially embryonic stem cell derived therapy or adult stem cell derived therapies. We do not know which is best and we cannot possibly know until we have looked at both and that is what we need to do.

  Professor Murdoch: I am a clinician, not a clinical scientist, but I think all the evidence would suggest that these are separate but parallel lines of research and it would be very sensible, if we really want to make stem cell therapy reach its full potential, that we move along both lines at the same time. Some of the evidence that comes from studying adult stem cells will help in embryonic stem cells and vice versa but, at the moment, we do not know and no one knows where the end point is going to be. I think you have to remember that a lot of the people who are saying that we should only work with adult stem cells and not with embryonic stem cells are not doing it on the basis of scientific evidence, they are basing it on their views about using embryos for research, which we can respect but where their views are coming from has to be taken on board.

  Q1122  Dr Harris: There are regulations about creation of embryonic stem cell lines from embryos because a value is placed on an embryo and there are regulations. Do you think that once a cell line is established, there should be less regulation and, if so, how much less regulation should there be about what you then do with a stem cell line derived from embryos? In other words, do you think there should be an application to a body, the HFEA or a similar body, for permission or should it be a research tool once it has been established that requires funding clearly and so forth?

  Professor Murdoch: If you take an adult stem cell line from a patient to do a study on it, you will be give permission to do that with appropriate ethical approval that will say what you are doing in the lab but there would not then be any specific regulation in terms of what goes on in the test tube in the lab in terms of putting chemical X with it to see how it grows and to see how it is handled and I do not really see why there should be any difference therefore for the embryonic stem cell line at that level.

  Q1123  Dr Harris: As long as you have the patient's consent for this sort of research.

  Professor Murdoch: Exactly. It does not need another outside body overseeing it as well.

  Q1124  Dr Harris: So, we should be able to genetically modify for research purposes embryonic stem cells lines without regulation from an external body.

  Professor Pedersen: If I may interject something here. I think it is rather naïve to portray the circumstances as if there were no current regulation or no current body. That may be deliberately so because you like to raise the question of whether there should be an additional body. I should be the last person to point this out because everyone here should know the law better than I, but the law which enabled this research to go forward that was passed in this House required the establishment of a body to oversee the research and that body has the authority and the responsibility to do so: it is the Stem Cell Steering Committee and it is chaired by Lord Patel. Everyone who works on embryonic stem cells in the UK has to report to that committee and seek permission from that committee in its role as overseer. So, I do not understand why the question is being asked as to whether there should be a body because there is one.

  Q1125  Dr Harris: We are reviewing the regulatory framework and we will issue a report suggesting whether it is over-regulated or under-regulated. What I am trying to tease out is whether the current regulatory system is onerous, necessary and appropriate or whether we were just a little sensitive at the time and we can get rid of a level of bureaucracy and rely on the existing normal methods of scientific oversight as one would with adult stem cells as Professor Murdoch just said. It may be that you like filling in application forms to Lord Patel. Some scientists tell us that they would rather not have that extra level of bureaucracy.

  Professor Pedersen: If the question then refers to the effectiveness and the onerousness of complying with Lord Patel's committee, I think that there have been some responses early on to the effect that it was onerous. I think I myself had the first response to the committee on an application to export cells to Sweden that we had been studying. It of course is onerous to participate in self-regulation and Lord Patel's committee is a regulatory body, not a body that is encoded in statutory regulations as the HFE is a self-regulatory body. Of course it is onerous but that is the price of doing research in full compliance with the public trust and I think that eventually even those of us who are measuring it just on paperwork will comply with that because it is a reasonable cost to pay for the opportunity of doing this research.

  Dr Lovell-Badge: I think I disagree. I think that once you are doing experiments on a cell line, whatever cell line it is, in vitro in the lab, then I think there are going to be pretty much no circumstances where that needs to go to a regulatory body. Maybe a local ethical committee to some extent but I do not think it needs any other further level of regulation. If you are going to then take those products from the cell lines and do something with them, then obviously that has to be regulated in some way and there are other ways that is done. In any transplant medicine, for example, you have to have the right sort of approval for that. I cannot see that there is any real need. The only matter you have mentioned was public trust but I think there is no real fear if you are just doing experiments in the lab.

  Q1126  Dr Harris: Professor Murdoch, the casting vote!

  Professor Murdoch: I would tend to move that way.

  Q1127  Dr Harris: For the record, please.

  Professor Murdoch: The UK stem cell bank is a relatively new body and is not fully operational yet; it is still finding its feet in terms of how it works. I would like to see it move towards a less formal regulatory process for what goes on in the laboratory than it has been tending to take on board at the present time. There are a lot of issues in the regulatory process which the UK stem cell bank has set up which are still being debated. It is a voluntary group and there is dialogue going on. Some of the issues that they have suggested we have are just not practical and cannot be done, but they are listening to what we are saying and are coming back and negotiating on them. I think there is the potential that, if it goes as far as it is suggested it might do, it might be disinhibitory to research rather than actually helping protect anybody or anything from any harm that is going to come. We should not have regulations for the sake of it, we should look at the risks and what we are trying to protect against and I think the risk of what you are doing in the lab helping to learn how stem cells grow is actually very small.

  Q1128  Dr Harris: My last question is about your evidence from the Newcastle Fertility Centre which I found difficult to follow with this nucleus and faux nucleus and I suspect that, if I had a bit of difficulty, then others might have as well. As I understand it, it is not possible at the moment to allow a defective egg to fertilise, that with a faulty mitochondrion, and then take the nucleus and insert into a nucleated donor egg with a good cytoplasm and good mitochondria. That is not permitted under the existing wording of the HFE Act. You talk in your interesting evidence about how you think that the pronucleus is the thing to be transferred and I would be very grateful if very briefly but in straightforward terms you can tell me whether the things I have just raised are different issues and, even if they are, whether you think the Act needs to relax a little about the former case I suggested in case that turned out to be useful.

  Professor Murdoch: This is an application that is pending with the HFEA at the moment from my scientific colleague Mary Herbert; it is not my name directly on that at the moment. A pronucleus will only have half the number of chromosomes as an adult nucleus. A female pronucleus will have half the chromosomes in the female from the egg and the male pronucleus will have half the chromosomes from the male and it is only when you put the two together that you will actually get a full complement of chromosomes. So, that is where the main difference comes between nucleus and pronucleus. I think there is a fundamental issue that is important in terms of the Act and restructuring the Act here and that is that the existing Act puts into primary legislation certain things that we can and cannot do and gives very specific terms and identity. You talked before about what is meant by embryo and it comes back to that sort of issue. If you use these words in primary legislation, it then becomes very difficult, as new techniques develop, to go back and interpret them and to get some understanding of what was meant initially when people said that in the Act and change it as things have moved on. For instance, the other issue in relation to that that is coming up is that we are not allowed to change the genetic structure of an embryo and I am sure that was originally put in the Act with the intention of making sure that people did not alter the genes in the nucleus and do that sort of process, but of course there are genes in the mitochondria and therefore what we are trying to do to help people who have serious mitochondrial disease to have a healthy baby suddenly falls under the wording in the Act which it was never intended for. So, one possibility of restructuring the Act is that you actually avoid putting these dogmatic statements in primary legislation and maybe devolve that to a secondary body of the good and great and the people who are interested to actually look at these issues as they arise and decide whether they are now, in the present climate, appropriate things for us to be doing in research. That will give us the flexibility to move on much more quickly than having to do it as we did with nuclear transfer, go back to primary legislation and actually change the Act to do it. As long as it is for the body that has the authority and the confidence of Parliament and the public, I think that might be a better way to go about it and it would get over some of those problems.

  Q1129  Dr Harris: That is secondary legislation; you have to wait a long time.

  Professor Murdoch: Yes, it still takes time.

  Q1130  Chairman: For the record, will the day come when we will not need many stem cell lines? We may only need 15 or 20. You shake your head, why is that? There could be one on every street corner.

  Professor Murdoch: There was a meeting in Newcastle recently when we were looking at how many stem cell lines . . . The North East has a fairly static population but they reckon that, in order to meet full complement tissue matching, you need about 700 stem cell lines just for the North East population. Given the rate at which you can generate stem cell lines at the moment, which would need about 100 spare embryos in one stem cell line possibly, you are talking then about 700,000 surplus embryos. That is just for the north east of England. I think the reality of actually being able to generate enough stem cell lines that tissue match all the population is not realistic.

  Professor Pedersen: I would say that this discussion has only begun and the data are not yet in the public domain with which to address it. The challenge is to make reasonable estimates of how many embryonic stem cells lines would be needed or, for that matter, any source of stem cells would be needed to tissue match the UK population and then to discover methods of obtaining those in a patient transplant quality with the highest efficiency in order that we do not waste the material.

  Q1131  Mr McWalter: I am very interested in many of the things that you have been saying. One of the things, Professor Murdoch, that struck me was that you indicated that the reason why all this is so difficult is because the stuff/material that is in your lab is, in the first instance, an embryo and that is obviously the reason why there is huge public concern about it. One of the issues then is that many of the people to whom we have talked have said that that needs to be treated with respect. Your words were that it has an identity. I can think of a friend of mine who has had two children through IVF and the spare embryos are now sitting there and then the issue is, what do you do with them? The Vatican has effectively said that you do not have IVF really; you generate three embryos and you implant all of them; you do not have a spare embryo from them. Assuming that one does not want to go down that line and one wants to treat these materials with respect, I think that my friend would actually want those embryos to be used to further human knowledge for the overcoming of avoidable disease and suffering. I think she would see that as the best way forward for those materials that have come from her and her husband. So, I do understand that treating with respect might involve being in a lab, in the same way as keeling over and donating your cornea to someone you have never met is also a treating with respect of the human body, so I do understand that. Then you said that when you generate a stem cell line from the embryo, then the rules change and Dr Robin said. "Now it is like sodium chlorate in a test tube. I do not want anyone telling me this is very special sodium chlorate; I do not want anyone telling me this is very special material when I have to continue, for instance, to inform the people who gave the material its identity what happened after the embryo became the originator of the stem cell line." Why do you not accept that maybe that material also needed to be treated with respect? You were sort of in the middle but you went more towards Dr Robin's view.

  Professor Murdoch: I would not say that stem cell lines should not be treated with respect. Anyone who deals with stem cell lines knows that they have to be treated with respect or else they die, basically. So, yes, there is some respect there. I think it is to do not with respect that you give them but actually how you look at them and how you process them and care for them. Every embryo that you create in an IVF laboratory has to be individually identified and we have to be able to account for it to the HFE. If an HFE inspector comes in, they will say, "Where was that embryo? Where is that embryo? Where are your records to say what happened to it?" Once that becomes the stem cell line, you are now talking about millions of cells. Are you going to account for every single individual cell? If you count them as groups of 100 cells, then is a group of 100 cells different from the millions? They are different. I am not saying that you do not respect a line for what it is and where it has come from and its value, but you cannot subject it to the same degree of regulation and monitoring in practical terms.

  Q1132  Mr McWalter: The one thing you might do, apart from telling people who, say, donate these embryos and they regard that as the appropriate thing to do with them, is undertake to keep them informed about the research. So that they do not have only the thought, the embryo was in a lab somewhere and got used in a lab but to inform them more about the research. Then they would have a continuing interest in what you were doing and see beyond simply the fact that the embryo is now no longer, as it were, recognisable as the embryo they created. I do not see why you do not have some sort of continuing interface with the people who generated that material in fact out of mutual love and all the other things that go into it.

  Professor Murdoch: Because those stem cell lines are not their baby.

  Q1133  Mr McWalter: I understand that. It is degrees of respect and you might find ways of integrating that concern into the ethical framework.

  Professor Murdoch: Patients who give consent—and do not forget that the processes of consent are rigorous; in our unit at the moment, we have a nurse who is funded by the MRC specifically to work fulltime to talk to patients about the research that is going on in the lab; she has nothing to do with the clinical work at all; so, it puts an interface between the clinical service and the research service—are given the opportunity to get information back about anything that might be found out that might affect their health and their children's health in the future and they can choose to do that or to not do that. They are not given the opportunity to be given specific information back about what happens to any lines that might be derived from their embryos. My own personal view is that I think that is probably the right thing to do. Do not forget that I am treating people with clinical problems and some of these people do not get pregnant from treatment and some do and it is a huge psychological problem that they have. To then burden them with the problem of how they then regard a stem cell line that might be generated from an embryo I think is actually too difficult for them. If they do not feel that they want to participate in the research on the basis that they are not getting that information, they do not give consent, so they do not agree. It is discussed with them and they are given that opportunity. Just to give you some feedback, since the nurse was employed in September, previously we had had a very sort of hands-off approach, so the number of people consenting to give embryos for research was 50-60%, that sort of order. Since she has been there and we have been able to give people more information, about 17% of the people whom we see say at their first visit when they come for IVF when I say, "There is research going on here", say, "No, I don't want to participate" and they are not involved any further. Of those that go on and they ask for information and are given further information, 87% agree to use any surplus embryos, these are embryos that would otherwise be discarded, for research. The reasons they give are that if people had not done research on embryos in the first place, they would not be there having an IVF treatment. They recognise that these embryos are going to be discarded; they are no use to anybody; they cannot be given to anybody else; they are there and they want them to be used and I think the views of the patients whose embryos they are have not been listened to previously hard enough in this debate.

  Q1134  Mr Key: Scientists might say that we are dancing on the head of a pin but a lot of other people would say that we are dancing with angels in trying to get to the bottom of this issue. We were told by previous distinguished witnesses that scientists really cannot define an embryo, "it depends who you are talking to", we were told. So, what is so special about the moral status of an embryo if we cannot even define one?

  Professor Murdoch: I think that is a real problem in terminology and I can see where the issues are coming from in previous discussion. If you go out on to the street and say to someone, "What do you think an embryo is?" they will describe to you a tiny but fully formed moving foetus, so a moving thing with arms and legs and a heart that is beating. That is lay understanding of an embryo. The patient having IVF thinks of an embryo as the four cells they see on the screen before they are put back that might make them a baby. The Act of Parliament at the moment considers an embryo as being an egg sitting in a dish surrounded by hundreds of thousands of sperm with no intention of ever letting any of those sperm get inside the egg but, according to the law, that is an embryo. Clearly these are completely different things. Therefore, we have to use different words to describe them. There are different words to describe them—you can use larcisis(?), you can use zygote at different stages, but I think that we will have to find a different word because they are different things. Clearly, there are issues in terms of public perception, public education and understanding of what we are doing but, if we persist in using the term "embryo", we are going to get it wrong. One of the headlines in the newspaper when the nuclear transfer issue came out had a picture of a fully-formed embryo as an illustration and that is wrong. It is misinformation.

  Q1135  Mr Key: Professor Murdoch, you just said in answer to a question from my colleague, referring to your patients, that it is too difficult for them. Our problem is that we are trying to find a way of describing something in law which will be applied for as long as possible. The law will not fall into disrepute because we do not do our job properly. Do you think there is a conflict of interest between stem cell research and fertility treatment given that every embryo donated for research could theoretically become a baby?

  Professor Murdoch: There is potential conflict of interest and I think part of the current regulations which are very tough are designed to minimise that conflict of interest. Regardless of what the HFEA would say, the licences that we have go to the Ethics Committee before they get seen by the HFEA and one of the remits of the Ethics Committee is to make sure that nothing is going to be done to the patient in the process of any research which will harm their primary treatment. So, there are not just the HFEA but there are standard regulation procedures already that cover that. I think that, in the UK, we probably have it about right. One of the difficulties you have in other countries in the world is where people are saying, "We are going to create embryos, pay people to give eggs/sperm specifically to make embryos specifically for research." That might turn out to be the only way we are going to get decent embryos to do it but I think that, at the present time, the stance that has been taken in the UK, which is that we will use the embryos which have already been created which are going to be thrown away otherwise, is the appropriate way to do it and we have to come to terms with potential conflicts of interests.

  Q1136  Dr Iddon: Will it ever become possible in your view to abstract stem cells from an embryo without destroying the embryo? What are the benefits in doing that? How much effort should be put into it? What is the impact on regulation if it comes achievable?

  Dr Lovell-Badge: It could be done; the techniques are available to do that simply by beginning as you would PGD, on an embryo, and take two cells and derive embryonic stem cells from those.

  Q1137  Chairman: Why do you not do that then?

  Professor Pedersen: This may be an overly technical answer, but one of the rules, that is to say a fact, that we know applies to all mammals, of which we are a member, is that the early development of the embryo before implantation into the uterus depends on the total mass of cells and anything that is outside becomes the placenta. That is the rule. So, unless you have a big enough mass to have an inside, you get no stem cells except placenta. That is why it is very difficult to take a bit of the embryo and achieve this. You could, in principle, take just the inner cells out and leave the placenta alone, but then it would not develop except for as a placenta and a placenta does not grow without the inner cells present.

  Q1138  Dr Iddon: And the impact on regulations? Can we see how you can change regulation if this becomes a common practice? Does the present regulation cover this adequately?

  Professor Murdoch: I am sure that current regulation as it stands would cover it because you are doing a manipulative process to an embryo, so it would come to a committee which would have to decide whether it was something that was justifiable to do and whether there was a good scientific basis for doing it.

  Q1139  Dr Iddon: Let me look at another difficulty now and that is bringing human and animal gametes together or cells together. Why is that necessary in stem cell research? What are the benefits we can gain from that and do you think it is ethical?

  Professor Murdoch: Are you talking about chimeras or co-culture?

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