PROFESSOR COLIN BLAKEMORE, PROFESSOR MARTIN BOBROW AND MR DAVID MACAULEY

5 FEBRUARY 2007

  Q240  Dr Harris: In the answers that you and Professor Bobrow have just given, you have made it clear that there may be scientific debate about how well this might work, but you do not seem to feel that there is any scientific disagreement about whether this should be permitted, subject to peer review, for funding, ethical peer review, and so forth. Therefore, is it the case that you would disagree with the statement made, there is not clear agreement within the scientific community about the need for and benefits of this science? That is from the HFEA press statement. Do you agree with that statement?

  Mr Macauley: No. I disagree. I think the HFEA was set up to deal with controversial issues like this, I think the areas covered under Parliament's grant to them, in terms of their role.

  Q241  Dr Harris: That was not my question, because you will have a chance to answer that point. Do you agree, all three of you, with the statement, there is not clear agreement within the scientific community about the need for and benefits of this science?

  Professor Bobrow: I do not agree with that. I think that there is reasonable agreement. The scientific community is like the Church; there is bound to be someone, somewhere who takes a different perspective. There is reasonable agreement that this is a reasonable line of inquiry. There would be considerable difference of opinion as to whether it is the one any individual scientist would put at the top of the list.

  Professor Blakemore: In a sense, that question would be answered by a good peer review process which would judge the applications for funds in area of research.

  Q242  Dr Harris: My final question along these lines is, if someone was proposing a ban and based that on the argument that, so far, I quote: "There does not appear to be a firm consensus within the scientific community about precisely which human-animal creation should be allowed, any immediate imperative for doing so, or the availability and interpretation of supporting evidence," do you think that is a valid argument for a ban?

  Mr Macauley: I think Professor Gillon probably said it right; unless there is a good reason to ban it then it should be allowed. I think that is an illogical statement.

  Professor Bobrow: The place to make those priority judgments is a scientific peer review, not in legislation.

  Professor Blakemore: If that had been applied, say, 10 or 15 years ago, i.e. any kind of ban on a combination of any human material with animal material, then we would not have the transgenic models, which involve the combination of human-animal material, which have produced disease models of enormous value.

  Dr Harris: That was the Public Health Minister, Caroline Flint, in her letter to the Observer, defending the ban.

  Q243  Chairman: We have always got to watch Dr Harris. You cannot retract.

  Professor Blakemore: No; but one can see the potential can of worms—can of worms is an unfortunate analogy to make—the potential pitfalls in legislation which starts with a comprehensive ban and then allows certain exceptions under licence, because there are so many potential exceptions. I very much hope that what will come out of this discussion is permissive legislation, in which areas of research that are not considered to be acceptable necessarily might not be allowed, but the generality would be.

  Q244  Chairman: You qualified that extremely well, if I might say so.

  Mr Macauley: In fact, there are a lot of issues; there is a Down syndrome mouse and there are mice which have been modified to look at other conditions as well. Whilst they are not covered by the HFEA, the Animals (Scientific Procedures) Act covers them; so if we were to ban, whether it is chimeras, hybrids, cybrids—there is a new definition for Martin Smyth emerged—we can preclude a lot of good work. We need to be very careful in terms of (a) the definition and (b) that we do not throw out the baby with the bath water, to use another inappropriate analogy.

  Q245  Dr Turner: I would like you all to comment, if you will, on how much benefit we have seen from stem cell research so far, and how soon do you think we will see some clinically applicable stem cell therapy?

  Professor Blakemore: You are beginning to sound like a journalist from the Daily Mail rather than a member of a select committee, Dr Turner.

  Q246  Dr Turner: Oh no; please do not say that.

  Professor Blakemore: The answer to the second question, how soon will we see clinical benefits, is very clear; we have them already. Bone marrow transplantation and the use of umbilical cord stem cells to treat genetic disorders and childhood cancers is very well established and very successful therapy. There are already strong hints, and David Macauley will be able to tell you more about this perhaps than I can, from early clinical trials about potential benefit in other areas, for instance, in treatment of heart disease. I think we are going to see a fairly rapid increase in the use of haemopoetic stem cells, adult blood stem cells, as potential treatments for a variety of conditions. It is going to take much longer before we can hope to see embryonic stem cells used, but I think there is enough optimism in that area to think that it will come.

  Q247  Dr Turner: I should have been more specific perhaps in the wording. I should have said embryonic stem cells, because that is what I meant really. Can you give a timescale on it, even approximately?

  Professor Blakemore: I would not expect to see really significant developments in less than 10 years, but there have been many, many, many other important beneficial advances in medical science which now are routine which have taken a lot longer than that.

  Mr Macauley: I guess it will go back to the Pattison Report, where Sir John said deliberately we do not know quite where the benefits will emerge, whether it is cord, embryonic or adult. On the specific question about embryonic cells, perhaps the first use of embryonic cells which would benefit patients would be their use in trying to establish work on drug toxicity so we can generate safer drugs. Broadly, you have a respond and non-respond with toxic, in terms of drugs. To try to better develop drugs, and embryonically-derived patacytes are leading the charge there, and a number of companies are developing those, and they will be used by the pharmaceutical industry to map against different populations so that therapy can be, again, better aligned to different ethnic groups, and so on. That is the first thing. To answer your question on time-line, we are probably somewhere in the five to 10 years away. The issue with embryonic stem cells, as everybody knows, is the propensity, in a laboratory, there is a wonderful discovery, it is called a stem cell line, i.e. where they continue to develop and they retain their potency after a number of passages; in the body, if that happens, it is called a tumour. The trick is, how do we take the cells and obviously get what we want them to do and to do no more. A lot of the underpinning work which is done by MRC and Wellcome actually leads to that fundamental understanding, and therefore if we ban this legislation we are handcuffing, you are putting one hand behind your back. There is an issue which has not emerged, I appreciate we are looking at the science here, but there is the whole competitiveness of the UK position here, and it is very much the quality of the science, as we all know about, combined with one important element, which is know-how. That is what has put the UK at the top table in this sector. I just feel this ban, apart from sending out the wrong messages internationally, I have had `phone calls from Canada, Australia, on this, horrified as to why we would be going backwards, why genuinely we would be moving backwards in this respect. The shock is that the UK was deemed, the mother of parliaments was mentioned, we had the mother of regulation in this area and it was copied all around the world, and it was seen as a leading example of an ethical, scientific-led way of developing what is often referred to as a sort of third industrial age, the huge potential which stem cells offer.

  Q248  Chairman: I am going to stop you there because I think we have got the message very, very clearly and I think it is something which we have had a lot of evidence on, about the importance of this research internationally and getting a decision earlier than possibly with the Government's timetable. Professor Bobrow; in response to the time?

  Professor Bobrow: In a sentence, the scientific question which is being addressed is how does a single cell grow up to be a Member of Parliament; and that is not a small question. To expect people to sort that out in five years and ask questions, I do not address this to you but to the world at large, to keep hammering on time-lines invites scientists to overstate their case, in a way which is actually detrimental to the public dialogue at large. I do not know whether it will be five or 10 years but I think there is massive potential and it would be daft not to try to follow it.

  Q249  Dr Turner: The opponents of, for instance, the cybrid proposals the HFE are stalled on, suggest that if that work was allowed it would actually hinder the general development in stem cell research; that is not my view but I would like your comments on it. I would like your comments also on justifying the funding of proposals, such as the cybrid work, as against other, more conventional methods of producing embryonic stem cells?

  Professor Blakemore: If the aim is to generate human embryonic stem cells and then study them, for potentiality—for the capacity to differentiate into different tissues, the possibility of using them for therapy, and so on—it is very difficult to see how this research could impede that, because the efficiency of generating embryonic stem cells by the other methods, in other words without producing animal-human combinations, is so very low. If the animal-human combination experiments allow us to improve the methodology to the point at which we can go back to producing stem cells from human embryos, it will surely be beneficial and not a hindrance. I find it difficult to see how anyone can be saying that the correct way forward is just to push on with the use of human oocytes, given the virtually zero success rate in using that technique, at least for somatic nuclear transfer, so far.

  Q250  Dr Turner: Do you feel that the opponents, who have been putting this view about, and the public are actually aware of that very straightforward justification which you have just given and really understand it?

  Professor Blakemore: I suspect that some of the opponents are aware of the arguments, but nevertheless have a particular position, perhaps based on religious views, or whatever, which leads them to reject those arguments. In the case of the public, I think there is a lot of misunderstanding and ignorance in this area against a background of general surprise and repugnance at the idea of combining human-animal materials. We have to work very hard, I think, to overcome that ignorance.

  Q251  Chris Mole: Mr Macauley touched on UK competitiveness just now. Can I ask the two Professors if you share the concerns at the risk to our leaving stem cell research, and is this a concern that we should be taking into account in this debate?

  Professor Blakemore: I have just come back from a meeting of the International Stem Cell Forum in Singapore, which was coupled with a two-day symposium with contributors from around the world. The pace of progress in this field, which was revealed in that meeting, is really quite extraordinary. We still have, I think, an advantageous position in this through a relatively liberal approach but with a very firm regulatory environment and great attention paid to the arrangements for banking of cells, for characterisation of cells, for sharing of information, and so on. This does put us in a strong position but with a lead which will very, very easily be lost, given the rate of progress.

  Professor Bobrow: In addition to that, which I entirely endorse, the long-term effect of creating an unpleasant public atmosphere needlessly around issues of this sort is that it discourages very able, young researchers from entering the field, and it can take a very long time to reverse that sort of trend, if it becomes established.

  Q252  Mr Newmark: Do you mean in this country, or will people take their software and move to the States, or elsewhere, and take their knowledge there?

  Professor Bobrow: We will have both; both of those. Some people, who are in the field, will move, and other people, who are at the start of their careers, will say "This looks like more trouble than it's worth. I'll go and do something else instead."

  Q253  Chris Mole: Can you estimate that competitive edge in months or years?

  Mr Macauley: I would not bet against the American Houses' federal funding for embryonic stem cell work by Christmas. Bush can only stand up with so many vetoes. Eventually he will capitulate and money will flow. At the moment, the analogy is we are watching this like sand running though our fingers, our competitive advantage, and this proposed ban does nothing but accelerate that.

  Q254  Chairman: Professor Bobrow, do you support that time-line, that it is as short as that, the competitive advantage?

  Professor Bobrow: Our most valuable asset is the inventiveness of the people working in the field. If they are giving evidence all the time they are not doing experiments. Not intended personally to anyone in the room, Sir.

  Q255  Mr Newmark: Having spent a little bit of time, as has `Dr Bob', looking at stem cell research, particularly at Harvard, looking at the progress which is going on over there, I am sorry if I am using the wrong words, are we sort of pissing in the wind here, in terms of what we can do over here, with the way we are being hampered by regulation, versus what is going on in the States?

  Mr Macauley: If we take the first case in your question, about regulation, it is the fact that we have sensible regulation which has allowed us to take the lead. This is seen by everybody that I speak to, and again this is not a scientific answer to your question, it is seen as a backward step, and it will put us back, and this is seen as a very sort of European response to all of this. The American money, there is a wall of private money building up in America. My answer to your time-line of Christmas, that is a political, inside comment from Washington I am referring to, that they will not bet against federal funding for embryonic stem cell work by Christmas, they think the money will start to flow. When the floodgates open and that money goes, because there was a comment, and it is a colleague of mine, Dr Stephen Minger, regularly would tell me, when he was in the States, with the Presidential ban in the States, the scientists' and academics' heads were down, they were demoralised, which was your point, and we have seen academics coming to this country to benefit from our sensible, liberal environment. Once the American money flows then who knows what will happen.

  Professor Blakemore: The argument that we might lose good researchers or lose a lead, whether it is economical or medical, if we were to introduce new controls, should not be an argument against such controls if they were valid. If we felt it was the right thing to do then surely it should be the right thing to do, even if it meant missing out on an international race in science. In this case, it is not the right thing to do, and the scientific community is really very united in that view. So it would be a double failure, if you like, to introduce legislation which is not needed and which also would give us a serious disadvantage in a very competitive and exciting area of science.

  Q256  Chris Mole: There was a specific question I wanted to ask Professor Blakemore, in the context of the stem cell lines which might be produced by this method. Who would regulate them? Presumably they would be deposited in the UK Stem Cell Bank, because there are concerns about whether those lines might be released internationally and used differently outside of the regulation in the UK. Could they be used as treatments in other countries, for example?

  Professor Blakemore: As I understand it at the moment, one of the applications which are under consideration by the HFEA is concerned with creating disease cell lines—that is lines which carry genetic disorders created by somatic nuclear transfer from humans that have genetic disease. These would never be intended for use in therapy but only for research purposes. Whether they would be deposited in the Stem Cell Bank is, I think, is a question for discussion. Whether, once in the Bank, they would be released for use overseas will depend on the regulations which now are being put in place, for exchange, for the release of such cells.

  Q257  Dr Harris: Only one of the applications for the use of such cells—

  Professor Blakemore: There are different purposes, as Dr Harris has explained.

  Q258  Chris Mole: Which regulations is it suggested are being replaced?

  Professor Blakemore: At the moment, our stem cell bank is drawing up rules of guidance for how and when cells should be released and how they can be exchanged between banks. The rule of thumb is that they would not be released into a scientific environment which is not comparable, as it were, with the position in the UK.

  Q259  Chris Mole: Is that something which the Government needs to regulate, or not?

  Professor Blakemore: I think we have regulations in place which can deal adequately with virtually any of the possible scenarios which presently we have under consideration. The crucial issue here is whether you define the product of the combination of animal-human material as human or animal. There are very clear rules of thumb there that one could follow. If the product is deemed to be human then we have the HFEA; we have the 14-day rule; we are not allowed to reimplant: it is all very straightforward. If it is animal, we have the Home Office and the Animal (Scientific Procedures) Act, with law, which is flexible, which changes with experience, which is open to peer consultation, and which I think would handle very well the creation of human-animal chimeras.