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I know that many of those who voted for embryonic cloning in 2001, and who will vote for animal-human hybrids, did so out of a genuine humanitarian desire to help those who suffer from disabling diseases. I do not believe that anything divides us in this House in our determination to try to do that, but were those beliefs well founded?

It may be instructive to note the subsequent widely reported comments of the noble Lord, Lord Winston, in 2005. He said:

To pretend that the creation of hybrid embryos from animal eggs will offer a desperate patient with motor neurone disease their only hope of a cure, as was prominently asserted earlier this year, is perpetrating yet another piece of fiction which does no service to the seriously ill.

Perhaps now would be a good time to pause and similarly ask what the creation of interspecies embryos might realistically promise. In his speech on Second Reading, my noble friend Lord Walton of Detchant inform us that,

would not require suppression of the immune response. Indeed, he went on to say:

In due course, I know that the Committee will greatly appreciate it if my noble friend would be willing to explain how it is that cells containing proteins from a distantly related species would not provoke an immune response, yet stem cells taken only from the same individual supposedly would. In expounding such views, I also trust that my noble friend will explain fully how one can be so sure about

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the developmental potential of such a cloned interspecies entity, especially without implanting it in a womb or crossing the 14-day limit.

In our debate in January 2001, my noble friend was sceptical about progress using adult stem cells, stating that progress would take many years of fundamental research. In his speech on Second Reading, my noble friend also commended an article by Julian Savulescu on the purported benefits of attempts at human cloning with eggs of distantly related species. I hope my noble friend will take the opportunity to dissociate himself from Professor Savulescu’s previously expressed views in favour of reproductive cloning or the harvesting of tissue from cloned foetuses.

Meanwhile, Her Majesty’s Government seem decidedly confused regarding whether the potential use of a technique known as tetraploid complementation would fall under the remit of the Human Fertilisation and Embryology Act if human embryonic stem cells were injected into a tetraploid embryo of another species. Tetraploid embryo complementation is already a well established technique for deriving mature mice entirely from mouse embryonic stem cells in which the cells of a tetraploid mouse embryo give rise to extra embryonic tissue, such as placenta, while the mouse’s embryonic stem cells contribute directly to the developing foetus.

The Minister has stated that the reference to,

as proposed to be inserted under Clause 4(2) of the Bill has the scope to cover any predominantly or substantially human organism that conceivably may be created by injecting human embryonic stem cells into an embryo of another species into which the animal cells primarily produce extra embryonic tissue.

I invite the Committee to contrast those remarks with those of the noble Baroness, Lady Royall of Blaisdon, and with those previously made by the noble Lord, Lord Hunt of Kings Heath. He stated that an animal embryo altered for an experimental or other scientific purpose by the introduction of one or more human cells will be governed by the provisions of the Animals (Scientific Procedures) Act 1986 once it reached the half-way point of gestation or incubation. That was given to me in a Written Answer on 28 June 2007. Subsequently, the noble Baroness, Lady Royall of Blaisdon, stated that if the cells that make up an embryo contain at least a haploid set of human chromosomes and at least one sequence of animal DNA, including a tetraploid complement of animal chromosomes, then it will be regulated as an interspecies embryo, but the regulation of animal embryos that contain single or multiple human cells is not within the scope of the Bill. That was given in a Written Answer on 12 July 2007.

Under which legislation would an embryo fall if it contained a significant proportion of human embryonic stem cells, which obviously themselves contain at least a haploid set of human chromosomes that have been injected into a tetraploid primate embryo? The evident confusion displayed by the contrasting answers from Her Majesty’s Government on this potential issue have not inspired much more confidence in the ability

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to regulate such research than the extensive indecision of the Human Fertilisation and Embryology Authority regarding whether it could regulate the so-called “cybrid” embryos. Such confusion may be especially disconcerting in the light of Dr Stephen Minger’s comments to the Joint Committee on the Human Tissue and Embryos (Draft) Bill that it may be only a few years before someone will want to,

So much, then, for the 14-day limit as applied to interspecies embryos.

In 1990, in opposing the first Human Fertilisation and Embryology Bill, I quoted in another place scientific opinion that doubted the scientific worth, let alone the ethics, of human embryo experimentation. I quoted an intervention from a debate in your Lordships’ House by my noble friend Lord Walton, whom I respect enormously although we disagree fundamentally on this issue. I seem to have been arguing with him now for the past 20 years. He had been asked what significant cures or advances in treatment had been achieved. He replied,

In 2001 when I divided your Lordships’ House, when close to 1 million human embryos had been destroyed, I asked the same question. No one could point to a single cure, yet we then authorised the cloning of human embryos. Seven years later we are now being asked to permit the creation of interspecies embryos. Although some 2 million human embryos have now been destroyed or experimented upon, the answer to the question remains the same. Cures—around 80 are now documented—are coming through adult stem cells, not through interspecies manipulation.

We should be clear-sighted. We should think wisely about what we are being asked to authorise. Having done so, we should reject these proposals as a step too far. I beg to move.

Lord Harries of Pentregarth: I was not able to speak at Second Reading, so it is appropriate at this stage to declare an interest as a member of the Human Fertilisation and Embryology Authority, which is relevant to all stages of the Bill.

I have three points to make in response to the noble Lord, Lord Alton. First, in his first intervention today, he held before us a spectre of science that he termed “brutalism”. He set out a rather frightening future of the kind of world that might come about through science. We are always right to be wary, but there is another view of science: that it is a great blessing, that we are meant to use our minds in order to interact with natural processes to bring about human health and healing. He used the word “artificial”, and people sometimes say “unnatural”, but it is natural for us to use our minds in order to enhance human welfare and well-being.

The second point concerns this set of amendments. I presume that what is really being referred to is cytoplasmic hybrids. There is a case for looking separately at so-called “true” hybrids because, as the

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noble Lord rightly said, there is not a great deal of scientific pressure at the moment to do research on true hybrids, but there is a lot of such pressure to do research on cytoplasmic hybrids. The reason is clear: there is a great shortage of human eggs. If it were possible to do this research using animal eggs, there would be a virtually unlimited supply. I remind your Lordships that we are talking about research that is essential for the future.

Thirdly, the noble Lord mentioned the new research from Japan that might make it possible to produce pluripotent stem cells without destroying embryos, which is very exciting and promising. But when applications for licences for research come before the HFEA, one of the first questions it asks, if research on embryos is proposed, is whether it is possible to do the research other than by using embryos. In the future, therefore, if this new research line looks possible, the HFEA will quite rightly have to say to the research team, “Is it really necessary for you to use embryos?”.

The use of cytoplasmic hybrids is a very promising line of future research. Your Lordships’ House should approve it and make it possible.

5 pm

Lord Patel: I apologise for taking more of your Lordships’ time. The noble Lord is quite right: I said at Second Reading that Yamanaka had used in his work in Japan vectors which subsequently produced tumours in mice. He is right also that only last week—in fact, just a few days ago—there was an article in Nature Biotechnology headed:

That meant that there will not be tumorogenicity of the same degree, but I shall come back to that in a minute, because the story is not quite as glorious as the noble Lord just made out. He was quite right, though, that science is moving fast in this area and may be promising.

There is no doubt that this recent publication, related to induced pluripotency in adult cells, is a scientific advance that most scientists working in stem cell science would not have expected to come with the speed with which it has. It heralds tremendous promise for achieving every stem cell scientist’s holy grail—the noble Lord, Lord Alton, will remember that I mentioned it—of being able to reprogramme an adult cell to a pluripotent cell and differentiate it in the cell types that they need to treat the diseases. That is what every scientist is chasing. It is not that they wish to do embryonic stem cell research for amusement or any other purpose; it is solely for the purpose of looking for treatments.

I return to the main point of the amendment, which relates to two issues: interspecies embryos, and embryos created for cell nuclear-transfer technology. Perhaps I may read a document that I received from Sir Martin Evans, this year’s winner of the Nobel Prize in Physiology or Medicine. He is the man who identified embryonic stem cells decades ago and showed that it was possible to obtain cells with

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normal chromosomes from early blastocysts. In a recent publication, Jamie Thomson, in Wisconsin, first identified chromosomally normal stem cells from human embryos and early blastocysts. Sir Martin states:

Those factors are viral factors. In the original article by Yamanaka, there were four factors. One of them was an oncogene called Myc, which subsequently induced tumours in the mice. Their oncogene is now removed. What if scientists removed that and used other vectors to induce pluripotency? Yamanaka said that he had induced in his experiments 20 factors in every cell. That means that the chance of a cell subsequently derived not having any of these factors in it would be one in 10 million. We do not know at this stage what results that may produce.

The Bill defines four types of interspecies embryo and prohibits creation and use of these except under licence. At present, the main research focus for the use of those entities would be the use of cytoplasmic hybrids, as the noble Lord said—and I agree with him. Scientists currently wish to use only cytoplasmic hybrids to do the experiments, and not others. The Bill also allows for further regulations to be made by the Secretary of State to include other as yet unforeseen and therefore indefinable entities in the remit of the legislation.

Stem cell research is one of the most exciting areas of 21st century science, as has been said many times. I have said before that if last century was the century of the physical sciences, it looks as if this century may be the century of the biological sciences. If it produces the same degree of advances as the physical sciences produced last century, our lives will be changed—and certainly, the lives of those with debilitating diseases will be changed. As we all know, the UK has an international reputation as a leader in stem cell science.

Somatic cell nuclear replacement technique may prove a reliable method of generating human embryonic stem cells, with particular properties that are not readily available using donated supernumerary embryos. SCNT, as somatic cell nuclear transfer is often referred to, has three specific aims: to create disease-specific stem cell lines that can be used to model disease processes and open up new opportunities for developing therapies; to generate stem cell lines with particular genetic backgrounds to be used in drug development assays; and to create patient-specific stem lines for therapeutic use, which would avoid rejection by the recipient immune system, because they are either created using a patient’s donor cell nucleus or selected to be immunocompatible.

SCNT techniques have proved effective in numerous animal species. Just two weeks ago there was success in achieving SCNT in monkeys, which suggests that current technical barriers might be surmountable. Nevertheless, many eggs will be required to develop SCNT techniques to derive

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human stem cells, and the problem with SCNT is the low availability of human oocytes, which is limited by the prior needs of patients undergoing infertility treatment and the invasiveness of the donor procedure. It may therefore be more acceptable to use animal rather than human eggs, since they could be used to generate cytoplasmic hybrid embryos for the derivation of embryonic stem cell lines of essentially human nature. At the time when these cells are harvested from the blastocysts, most of the genetic material is human to the extent of 99.9 per cent or more. Some say that if you harvest it early enough it would be virtually 100 per cent, because more of the animal material from the mitochondria is transmitted later in the blastocysts. Animal eggs are readily available from abattoirs.

Proposed research on interspecies embryos in the United Kingdom would involve taking the somatic cell from an adult with a degenerative condition and placing the nucleus in a nucleated animal egg to create stem cell lines to use as diseased models to study pathogenesis and test therapies. Currently, SCNT-derived cells could not be used therapeutically, and no one has the intention to do so, given the exposure to material of animal origin. I say “currently” because we do not know whether it will be possible in science in due course to remove all the animal material. In the United States it is likely that within two years the original embryonic stem cell lines created by James Thomson will be used, with FDA approval which has already been given. Those stem cell lines had rabbit feeder cells; by using a scientific technique, those feeder cells have been removed. The FDA has accepted that technique and allowed permission for those cells to be used for therapy for the first stage of the trial.

Generation of cytoplasmic hybrid embryos using readily available animal eggs would also provide invaluable experience in SCNT technology, thereby increasing technical efficiency and expertise so that a much smaller number of human eggs would subsequently be needed to generate “patient-specific” stem cells that could be used for clinical treatment. The information and technique would also be relevant in research looking at deriving stem cells by programming adult somatic stem cells. In that respect, I also have to say to my noble friend Lord Alton that a technique of reprogramming adult cells to become pluripotent cells used the technique developed by using embryonic stem cells. Without learning from embryonic stem cells, that particular technique would not have been possible as we had to know which vectors were needed to induce pluripotency. My noble friend may challenge that and we will have an interesting discussion if he does.

Recent advances in the methods of direct reprogramming of human somatic cells without the use of oocytes or early embryos, from the Thompson and the Yamanaka groups in the US and Japan, are exciting and welcome. However, that work is at a very preliminary stage and the current technology involves engineering the cells in a way that raises a number of safety issues that will need further refinement before the use of iPS cells in the clinic can be contemplated. To give one example: adult cells have a problem with

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what we call telomere, or the ageing process. If these cells are used for therapy there will always be a problem because of the loss of telomeres when inserted for treatment. They may produce cancers in the patients treated because of the limited senescence of these cells.

Not enough is known about any particular route to generating stem cells to be sure of predicting which approach will bear fruit, and all avenues of research should be left open. Discoveries in all types of stem cell research inform the field and have the potential to accelerate the delivery of safe and effective stem cell therapies. Indeed, the leading stem cell centres in the UK and overseas contain groups that are working with both embryonic and adult stem cells, and no doubt iPS cell technology will be incorporated in the very near future. In fact, scientists in the UK have already started using the iPS technology following the two reports.

Regulating the creation of interspecies embryos for research under the strict regulatory regime of the Human Fertilisation and Embryology Act will ensure that it is undertaken in a responsible and appropriate manner, subject to rigorous transparent review. Such work will undoubtedly progress in other countries and it would be preferable for the UK to conduct research in its tightly regulated environment rather than rely on results from countries where the same standards may not apply.

The Bill clearly prohibits placing an interspecies embryo in a woman. Furthermore, interspecies embryos cannot be kept after the earliest of the following: the appearance of the primitive streak, or the end of a period of 14 days beginning with the day on which the process of creating the interspecies embryo began. The regulation is firm enough to stop that happening.

There are other issues related to induced pluripotent cells derived from adult cells because of the state of senescence that I have already mentioned. Even if they are made safe for transplantation cell therapy, iPS cells may be useful in patients of a certain age only before their inherited state of senescence turns the cells cancerous. What do we do for the teenager who suffers spinal cord injury in a motorcycle accident? The answer still has to be that ES cells retain real potential in that situation.

5.15 pm

One can assess whether induced pluripotent cells have the same behavioural potential as embryonic pluripotent stem cells by comparing them with the gold standard of embryonic pluripotent stem cells. My plea is that at this stage we should allow research on all types of stem cells: adult stem cells, cord blood stem cells, cord stem cells, bone marrow stem cells, embryonic stem cells, induced pluripotent cells and even menstrual blood stem cells.

Baroness Neuberger: The noble Lord, Lord Patel, made a very strong argument as to why the amendments of the noble Lord, Lord Alton, should not be accepted. I also served on the joint scrutiny committee and I am a former member of the Human

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Fertilisation and Embryology Authority. I want to add one point to everything that has been said. When we talked about the nature of interspecies embryos, we said how difficult it was to collect human eggs. This point has been well made but another point must be taken very seriously. If we are to continue with interspecies embryo research—I absolutely agree with those who say that we should and must—we must also recognise that there is a risk posed to women from overstimulation of their ovaries. It is not a great risk but it is a risk.

Adopting the technology of using animal eggs and human sperm to give us material on which we can do this research, which has the potential to be so very useful, is in my view preferable to encouraging more women to have their ovaries stimulated than need to do so for treatment purposes. We should look not only at the potential for the alleviation of suffering that this area of research might bring, but at trying to prevent suffering that could result if too much overstimulation of women’s ovaries should occur other than for treatment. We should take that point very seriously.

Lord Winston: I add to what the noble Baroness, Lady Neuberger, said, because it is a relevant point which has not been made in this debate hitherto. Indeed, one could argue that the stimulation of the ovary under any circumstances may produce abnormal eggs. There is growing evidence that the lesser the stimulation, the better the quality of the egg and the better the chance of the embryo implanting and being viable. Within the next three to five years more and more in vitro fertilisation programmes may not involve stimulating the ovary. I believe that this method of stimulation, which is used worldwide, is obsolete. That will make eggs more difficult to obtain because researchers and clinicians should be working with only one or two eggs. Therefore, there will be a growing need for eggs elsewhere.


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