Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 1111 - 1119)

WEDNESDAY 24 NOVEMBER 2004

PROFESSOR ROGER PEDERSEN, PROFESSOR ALISON MURDOCH AND DR ROBIN LOVELL-BADGE

  Q1111  Chairman: Can I welcome you all. You have been sitting through the first part and enjoying the attempt to define some arenas of the activity which quite clearly did not bother the last group too much but we will be asking you questions about other issues as well and I am very pleased that you have found time to come and talk to us. You know how important this inquiry is and how organisations are getting to grips with these problems now. I am going to start off with the first question. Roger Pederson, I want to get you on line really because we have talked about this in the past. As the man who came from California to undertake stem cell research, you missed Arnie Schwarzenegger and his amazing success over there in the votes and so on in the Presidential Election and his undertaking to conduct stem cells research. Do you regret that now? Would you go back to San Francisco and engage there with them with the multi-million dollars that they are going to throw at this or do you think you are doing the right thing and are we doing enough, are we doing the right thing, or are we just playing at it in this country? I want to get you on record.

  Professor Pedersen: It is an honour to be here and a privilege and I feel very special being a Californian Yankee in Queen Elizabeth's Court. Thank you for that opportunity. What I would say is that I came here for a very specific reason which was to accelerate research on stem cells to reach the patient community at the earliest possible date. I came here because it was clear to me at that juncture that the UK was the best place in the world to accomplish this. I have been asked numerous times why I reached that decision and it is very clear in my mind that the primary reason for the UK's past success and the potential future success rests on the foundation of public policy developments that have been made as a result of hard work on the part of many people including people in this room. That public policy was of course inspired by the success in in vitro fertilisation in Professor Edwards's hands some 25 years ago. So, there is a tradition really of successful public policy development in the UK that is unparalleled anywhere else including California. So, the simple answer is that I would not hear of going back to California where there is a mismatch between the initiative in California and the countrywide hostility towards stem cell research.

  Q1112  Chairman: The second part, Roger and Alison, and Robin can join in this too, is, what more do we need to do in this country to stay ahead of the game, as it were, to be upfront, to have that attractive value, to bring more Roger Pedersens over, not just from the States but from elsewhere in the world of course?

  Professor Pedersen: Thank you for that compliment. What I would say, if I may use vernacular with which I am familiar, is, if it ain't broke, don't fix it. I think that the HFEA works and that it is a huge part of the engine that drives forward stem cell research obviously insofar as it is related to embryo research in this kingdom. I think the important thing to do is to not dismantle or not provide a target for diminishing the effectiveness of the HFEA by opening up the doors to changes that might diminish its effectiveness. I think on the whole, at least in the timeframe that I have observed it closely, it has been incredibly effective. Obviously there are other things that need to be done. The HFEA in itself is not a sufficient cause for success in the stem cell field and I think that further public policy developments need to be undertaken, for which I compliment you and your Committee. I think this is an extraordinarily important role because what needs to be done is to look forward at the ethical, legal and social issues that are going to be brought out on to the table as a result of the progress of the technology and not stay mired in the issue of moral status of early human embryo. That is not the only issue and we will be blindsided by other issues that will come as a result of the progress in technology. I think there are other issues that need to be addressed such as long-term funding and the commitment to that, but that is a separate issue from regulatory issues.

  Q1113  Chairman: When will we move into the clinic, as it were, in your opinion? When will we be treating Parkinson's, Alzheimer's or whatever because those were basically the hard-line reasons that it got through Parliament and are we moving into that position? Are we up for that? Are we organised enough to do that?

  Professor Pedersen: I think that, in terms of your responsibilities for the public trust and the public welfare, you should be prepared for the risk, if I might state it that way, that the field will be ready to go to first inpatient work within five years which means that a lot of work needs to be done starting right now to consider the impact of that clinical undertaking in terms of distributive justice of the technologies—is it really going to be for everybody or is it just going to be available for the wealthy few?—in terms of the safety of the technique and in terms of the equitability of the choice of the diseases on which we focus, and I would focus on Parkinson's probably and have a treatment within five years.

  Professor Murdoch: I think the first obvious answer to your question about where we go now is money and I think that is probably not the remit of this Committee, so I will stick to the issues that relate to regulation. Despite any negative things that I might have to say about the authority, I think the fact that we have an act that regulates IVF treatment and research in embryos in the UK is the single most important reason why we have taken a lead worldwide in terms of stem cell particularly and, if you look at the situation in America, it is not just stem cell regulation, it is the fact that the IVF clinics are not regulated in the same way that we are regulated and do not have that structure of control that has slowed things down and still slows things down in America. Just putting money into California is not going to get them necessarily the answers that they need. So, the need for strong regulation in terms of the use of the embryos to generate stem cells is important and has to continue. I think there is an important issue in terms of perhaps slowing down what might regulate the progress in terms of embryonic stem cells work which is if the current IVF regulation then goes on into regulating stem cells. Once you have an embryonic stem cell line, the whole process of then what goes on in the laboratory in terms of developing it, differentiating it and using it. We have to be very careful that we do not tie down that research into a regulatory process. If you put that part of the regulation into the hands of the HFEA, into the hands of requiring ethics committees for each individual study that is done in the lab, then I think we will slow things down in the UK in a big way. So, we have to find some way of identifying that an embryo has a certain specific identity that has to be given certain respect but, once it becomes a stem cell line, even though it is called an embryonic stem cell line, it has actually changed, it is not the same thing and does not require the same strict regulatory processes that we have now. There are other ethical committees that can look at regulating that in a way that is more appropriate.

  Dr Lovell-Badge: I have very little to add. I think the attraction of the amount of money in California is certainly going to bring some people there. They are actively trying to recruit people and the amount of money is actually enormous.

  Q1114  Chairman: Do you think we could lose out to them?

  Dr Lovell-Badge: We could well lose some people to them simply because of the attraction of the money. That is an issue. Otherwise, I agree, I think it is far better to do this sort of research in an environment where you have backing from all sides and good regulation and I absolutely agree with Alison, I think it would be a big mistake to have work done in vitro in embryonic stem cells subject to any regulation apart from perhaps a local one.

  Q1115  Mr Key: Could we look at the awarding of research licences. In the 2001 regulations that Parliament has produced, it extended the purposes of research to include knowledge about the development of embryos, knowledge about serious disease and to enable such knowledge to be applied. Do you think that those regulations are adequate or should they be extended in some way?

  Professor Murdoch: I think they are adequate at the moment but they are in the process of being tested through the courts and I am not sure that it is the time now that we should be thinking about going back and looking at them.

  Q1116  Mr Key: We are going back and looking at them whether we like it or not. That is why we are here.

  Professor Murdoch: I have a particular difficulty in that the particular licence we have is now going to judicial review which rather limits what I can say to the Committee here.

  Q1117  Mr Key: We understand that. Would anyone else like to add to that?

  Dr Lovell-Badge: I think as always it comes to where you draw the boundaries as to what is clear. You were having this debate earlier about whether being infertile is sufficient justification to, for example, use embryonic stem cells to make germ cells.

  Q1118  Mr Key: Professor Pederson has given a five-year timeframe for some of this work. How should we regulate clinical trials in the future because we are only going to get an opportunity for an act like this maybe once every 15 years? We have to look ahead. How do we need to regulate clinical trials?

  Professor Murdoch: Clinical trials are already regulated. There are already considerable procedures that we have to go through. If I wanted to introduce a new drug into my clinical practice, there are various processes that I go through. If it is a drug that has been tried and tested, I would go to my Trust, I would go to the Drugs and Therapeutics Committee; I would give them the evidence to show that it was better than the existing and was cost effective and would be introduced into clinical practice. If it were a new drug, I would go through phase one, phase two and phase three so as to do it; it would go to Ethics Committee and patients would be informed and it would be appropriately funded. In terms of introducing clinical trials, I do not see any need to introduce any different model.

  Q1119  Mr Key: Are we all agreed? Does anyone have any concerns about the EU Tissue Directive and do you think that will have an effect on human stem cell research?

  Professor Murdoch: I have lots of views about the EU Tissue Directive. I think overall it is going to require an improvement in the quality system in terms of IVF laboratories and how they are run and, in that respect, the professional societies are supportive of anything that would improve quality. I think it is still going through the discussion process to make absolutely sure that the processes that are going to be required under the Directive are not so rigorous that actually it effectively stops the practice because theoretically it could do that. Overall, I think it is going to be an improvement on clinical service because, if you are talking about generating new embryos, the better quality embryos you have, the better the treatment will be and, the more effective it will be, the more likely it will be to be able to have patients coming through for treatment, the better embryos we will have that will be donated to research and the better stem cell research we will have. So, it will follow on. A good IVF unit is the one that is going to be working for the stem cell generation, not the bad IVF unit.

  Dr Lovell-Badge: I agree with that and I think it is very important. I am looking into some of this. I do not work directly on human material at all but, looking into some things that go on in different places, you see in IVF widely different rates of success, different rates of success of growing embryos, to blastocyst stages, and I think anything that can be done to improve the overall success rates of all the methods being used . . .


 
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