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Research on cybrids will allow scientists to learn how to produce disease-based stem cell lines using embryonic stem cells efficiently, or even adult stem cells in the future. Scientists need only a few such stem cell lines. They will also be important because they will carry disease markers for future drug development. The submission of the Medical Research Council and Wellcome Trust to the House of Commons is detailed and well worth reading.

The key elements for the future success of the UK in stem cell research are: strengthening centres of excellence to enhance interdisciplinary and translational research; supporting high-quality clinical studies, which in the near term are likely to be of autologous stem cells, and the stimulation of endogenous stem cells; support for key infrastructure; the integration of biomedical advances with engineering—delivery systems, cell matrices and cell production; the involvement of bioindustry to accelerate therapeutic development; capacity building, including the encouragement of young researchers in related areas of UK strength, such as cancers and developmental biology; a permissive but strictly controlled regulatory structure that both encourages research in this area and reassures the public over ethical and safety issues; and continued international leadership.

Therefore, will the Minister emphatically reassure the House that the Government, first, will fulfil the commitment on funding as recommended in the Pattison report; and secondly, in revising the legislation related to embryo research, will look at the scientific evidence and the wider public opinion and do not intend to bring, even in the interim phase, legislation that damages the current positive environment for stem cell research? I beg to move for Papers.

11.52 am

Lord Winston: My Lords, I shall concentrate entirely on human embryonic stem cell research. At some stage in the debate it will be said by some Members of the House that science is moving too quickly. Perhaps I may point out that embryonic stem cells were first grown satisfactorily in 1966. They were recognised to be able to invade tissues by Richard Gardner in Oxford in 1968. That is 40 years ago. It was Thomson who first grew human embryonic stem cells some 10 years ago. During that time scientists well understood the power and potential of stem cells. The fact is that we did not proceed with this area of science because we recognised that there was a question of its acceptability to the public. Scientists have been extremely cautious and entirely responsible throughout in the way they have conducted this research. There was one major case of fraud in Korea, but, that aside, there has never been a suggestion of lack of probity by anyone conducting this research in university centres.

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It is interesting to look at the publications regarding human embryonic stem cell research. We frequently boast in Britain that we lead the field and that we provide the ideal liberal environment for this research to be carried out. This week I trawled through 2,600 papers on the PubMed index which cite human embryonic stem cells. Of these some 530 report individual research of a novel nature.

Despite the presidential ban on embryonic stem cells, which has existed since 2001 in the United States, the United States leads by far with this research; indeed, consistently year on year it has published one-third more papers than all the other countries put together. Currently, some 208 publications are from the United States. Israel comes next—a country with half the population of London—with 55 publications. These publications are generally in higher impact journals than the publications from the United Kingdom, which comes third with 50 publications. Thereafter, there are a total of seven other countries which lead in this research, all of them smaller than the UK, some of them tiny by comparison, including Singapore, Sweden, Korea—which is a larger country with a bigger base—China, which has been mentioned, and Australia.

It is also interesting to look at funding in those countries; I have some figures on that. My noble colleague Lord Patel has already pointed out that Proposition 71 in California resulted in the promise of $3 billion in that state alone, which has roughly the population of the United Kingdom. In Wisconsin, $750 million has been promised and in New Jersey, $270 million. By 2005, Korea had promised $27 million, Singapore $600 million, and there is substantial funding in Canada and Israel. In China, perhaps the poorest country, although it is starting to gear up more rapidly, $132 million has been committed to such research. In Australia, just one centre in Melbourne received almost 100 million Australian dollars in 2003, I think, to set up the stem cell research centre headed by Alan Trounson. The following question has already been asked but I need to reiterate it. Will my noble friend the Minister kindly tell the House exactly how much money has been promised by the UK Government for stem cell research and how much has already been allocated and spent?

Despite what is widely thought, at least 33 countries worldwide have relatively permissive legislation along the lines of that in the United Kingdom. It is not clear how effective the regulations for that research in Britain are. Undoubtedly, the current system under the HFEA results in extremely long delays to research licences being granted. A researcher must first apply to his local ethics committee. On average, in a research area in Britain, that takes six months because of the overload on those committees. If there is anything wrong with the wording of the application, one can expect a further delay as it is rewritten and resubmitted. Thereafter, and only thereafter, can the application go to the HFEA. It is usual for there to be a delay of three months before it sees it. Again, if there is a need to correct the informed consent form, for example, that must go back to the local research ethics committee and the whole procedure starts again.

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Thereafter, it is sent out for peer review. My impression from my experience is that the peer review process is deeply flawed. For one application that I made, one peer reviewer did not even bother to reply to the HFEA’s correspondence. The HFEA never explained why not to my research group. After that—let us say that at least a year has elapsed, and that is an underestimate—one can apply for funding for research. Let us consider a PhD student. It is unthinkable that the backbone of British science, the PhD student, will wait for a year or year and a half for ethical and funding approval of a project. In effect, that means that we are losing young scientists in that area. So even though it seems that we are progressing that science well, in fact it is severely inhibited and there is a serious need to re-evaluate the legislation, not because the legislation is wrong, but because the way in which it is implemented is deeply flawed. That is just one example.

In the long term, we live in a complex world and I am not convinced that regulation is ideal. Germany, which bans such research, can import cells from the UK; Italians buy eggs from Oregon; Australians do their work in Singapore; the Chinese have a different view of embryos from that in almost any other country. We need a change in attitude to how we control the work that is going on, with a better understanding of the responsibility of scientists.

Baroness Royall of Blaisdon: My Lords, may I remind noble Lords that this is a timed debate, and ask that they respect the limit of six minutes?

11.59 am

Lord Soulsby of Swaffham Prior: My Lords, in the 17 years between the isolation of embryo cells in mice and humans, there was a realisation about the enormous potential that stem cell technology offered in the treatment of some of the most devastating and distressing diseases of man, which are sadly on the increase as the age of our population increases. Stem cell technology, the regulatory framework for its use, and the ethical issues that surround it are complex and bewildering, and we should be grateful that the noble Lord, Lord Patel, has initiated this debate, to which some very knowledgeable noble Lords who participate will bring their knowledge and wisdom to bear on the various issues which the noble Lord, Lord Patel, laid out in his opening remarks.

In the period between the isolation of ES cells from mice and humans, much work has been done to isolate those cells from other species such as rats, hamsters, cows, sheep and pigs. The ES cells of the rat, the mouse and the hamster have been used to generate transgenic animals, which serve as models for human disease and the creation of chimeras—embryos containing a mixture of cells from distinct cell lines—has proved to be an incredibly useful approach in biochemical and biomedical research to understanding the effects of specific mutations and their role in human disease. An important outcome has been the production of much more specific targets for pharmaceutical research and the reduction in the number of animals required for such work,

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along with the concepts of refinement and replacement—the three Rs of experimental animal use.

In the time available, however, I shall concentrate on two points. The first is the use of hybrid and chimera embryos, which the noble Lord, Lord Patel, mentioned, in motor neurone disease studies. The ultimate goal of stem cell research is, of course, to provide genetically matched tissue to the recipient, thereby avoiding rejection and the need to administer anti-rejection drugs. This is done by placing the nucleus from a normal body cell into an unfertilised egg, where it behaves as if it were in an embryo. Stem cells exactly matching the donor of the nucleus can then be cultured into specific cell types needed to repair the damage in the patient.

The success rate of this procedure in animals is low; it has not yet been achieved in humans, at least in this country. As the noble Lord, Lord Patel, said, human eggs are in poor supply. An alternative approach is to use animal eggs as a recipient for human nuclei, from which human ES cells can be harvested. The animal eggs—cow eggs or rabbit eggs are often used—serve as nurse cells, and the procedure is governed by the regulations on harvesting ES cells. However, as has been mentioned, the Government have published a White Paper, in which it is proposed that the creation of hybrid or chimera embryos should not be allowed on ethical grounds. The House of Commons Science and Technology Select Committee reviewed this and concluded that the Government’s proposals are too prohibitive, would stifle research on transgenic disease models, and would have a negative impact on medical research. Some 200 medical charities have petitioned the Prime Minister, no less, to allow such hybrid embryos to be developed. I sincerely hope that they are successful.

I wish to give an example of the use of ES cells in situations other than the human patient—in this case, the horse. In 2007, ES cells have been isolated from horse blastocysts—the early fertilised cell—at the Thoroughbred Breeders’ Association Equine Fertility Unit in Newmarket, in which I should declare an interest as chairman of its ethics committee. Such ES cells have the potential for therapeutic uses in racing and high-performance horses that suffer from sprained tendons, which, as anyone who deals with horses will know, are extraordinarily difficult to treat; treatment may extend over several months and often the horse breaks down again with a sprained tendon. Hitherto, treatment has been conservative, but recent work at the Royal Veterinary College has shown that, when injected into the damaged tendons, cells from the bone marrow—not stem cells—give temporary relief in the healing process. But the availability of ES cells from the Newmarket work will probably mean that those cells that are not rejected by the horse on an immunological basis can be used, stored and characterised, which will lead to a much more rapid and effective cure of sprained tendons.

Finally, mention has been made of the funding of research. I will not repeat what the noble Lord, Lord Winston, said, but I believe that we are living in an unsound paradise if we think that we are ahead in all

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research and funding; we are not. I hope that the Minister will take note of the absolute importance of funding.

12.06 pm

The Lord Bishop of Newcastle: My Lords, I, too, am grateful to the noble Lord, Lord Patel, not only for introducing this debate but for his distinguished contribution to this area of research.

Stem cell research is one of the most exciting, exacting, complicated and, for some people, anxiety-inducing areas of research today. Living as I do in the city of Newcastle, I cannot but be aware both of the possibilities that stem cell research seems to promise and of the ethical questions that it raises. The scientists at the Newcastle Centre for Life were the first group in this country to make a human embryo through cell nuclear replacement. Last summer, academic scientists and industrialists gathered in our city to look at the technology required to enable stem cell products to be made on a marketable scale. More recently, the North East England Stem Cell Institute has been set up through collaboration between the universities of Newcastle and Durham, the Centre for Life and the Newcastle upon Tyne Hospitals NHS Foundation Trust. Noteworthy to me is that this new institute has received significant funding from the regional development agency. The development of stem cell research is rapid, and considerable expertise has already been gained and established in the north-east.

The potential that this research offers in treating serious diseases and injuries is great. It is hardly surprising that interest groups and charities representing those diseases that may be cured through advances in stem cell research want to press on and to promote the research as far and as widely as they can. One of the key questions is simply whether the ends, laudable as they are, justify the means. Should there be any limits and, if so, where should the boundaries be drawn? Does the potential of the knowledge, the techniques and the cell lines developed through research on embryonic stem cells justify the generation, manipulation and destruction of human embryos? Is it appropriate to make human embryos purely for research purposes, never having any intention of implanting them in the womb?

Those are the kinds of issues that we continue to face, and more have been raised in the responses to the White Paper, not least to the proposal that the creation of hybrid embryos in vitro should not be allowed. Scientists argue strongly that hybrid embryos made through cell nuclear replacement have great potential in the development of human cell lines. As we have heard, one of the current difficulties is that human eggs available for research are in short supply. Most come from women undergoing IVF treatment. I am told that some researchers are having to wait three months for eggs before they can begin their work. Even then, the eggs released for research purposes will be those that are not regarded as suitable for fertilisation.

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It is for those reasons that scientists in Newcastle have asked permission to make hybrids using adult cells and enucleated eggs from animals. The argument is that the resulting embryo—or “cybrid”, as it is called—will be 99 per cent human and could be a valuable source of stem cell lines. There would never be any intention to implant such embryos, and they would be destroyed after 14 days. Such cell lines, it is argued, will be invaluable in testing drug treatments and in understanding the way diseases develop to help those suffering from a variety of genetically related diseases.

Not surprisingly, the White Paper proposal to ban hybrid embryos has raised considerable disquiet, not only from scientists but from the House of Commons Science and Technology Select Committee and of course from patients’ groups. That is why the HFEA public consultation has been launched, and why all the implications raised by human-animal cybrids, not just the possible medical and scientific advances, need to be given careful consideration.

To my mind there are a number of key questions that need to be addressed. What course of action will be the most honouring to the dignity of human life? Will it be the prevention of human suffering by the curing or treating of disease, or will it be in recognising that human embryonic material must be treated with the utmost care, reverence and respect? In any case, are those two options to be regarded as mutually exclusive? I, for one, do not believe so.

Is it appropriate or indeed accurate to consider these hybrids as embryos, or is an adult cell that has had its genetic differentiation somehow rewound no different from the human tissue from which it was extracted, as long as it is never implanted? That is the implication, as far as I can see, of the use of the term “cybrid” rather than “embryo”, and if that is the case, does it matter that the genetic rewinding was facilitated by an animal cell? Again, is it possible to define living cells and organisms simply in terms of their genetic make-up? Is it appropriate to call a cybrid 99.9 per cent human simply because that is the proportion of human DNA that it contains?

If it should be concluded that it is not right to make hybrids of human cells and enucleated animal eggs, what implications will that have for situations where animals are already being raised with small quantities of human DNA in their genetic material? I am aware, for example, of sheep that secrete human protein in their milk and of a mouse that is a model for Huntingdon’s disease, both the result of human genes being incorporated into their genetic material. Are these hybrids acceptable? If they are, what is the proportion of human DNA in an animal that would constitute either an appropriate or an inappropriate hybrid?

These are complicated matters in terms of both the scientific method and the ethical issues raised. That is why the HFEA consultation must include not only scientists, medical practitioners and patients’ groups but also ethicists and theologians. It is vital that future stem cell research in the UK, which will continue to pioneer new techniques if allowed, must do so within the clearly drawn boundaries and controls of a robust regulatory framework.

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12.13 pm

Baroness Greenfield: My Lords, I congratulate the noble Lord, Lord Patel, on bringing forward this timely and wide-ranging debate. I shall focus on just one aspect: the potential application of stem cell therapy in my own particular area of research, which is neurodegeneration. While other conditions such as heart disease and cancer are devastating, we all fear in particular the disorders that destroy the brain. They target the ability to stand up, to smile, to converse, to relate to others and to cherish memories of those relationships; indeed, to enjoy the full experience of being a unique individual. Yet the big problem is that we do not yet know why certain key brain cells embark on the pernicious cycle of self-destruction that we call neurodegeneration. The best we can do is combat the symptoms.

Current strategies consist of using drugs to replace the dwindling levels of the chemical messengers that result from the dwindling numbers of brain cells. But there are problems. First, inevitably, drugs will permeate into areas of the brain or body where they are not needed, and these cause side effects. In Parkinson’s disease, for example, treatment with a drug that will promote the chemical messenger in the area that is degenerating will also increase erstwhile normal levels of that same chemical elsewhere in the brain, so that the now excessive amounts risk psychotic side effects, such as hallucinations. Even where such treatment offers a temporary alleviation in the patient’s basic condition or a slowing down of the deterioration, it is hard to convince organisations such as the National Institute for Health and Clinical Excellence that the costs are worth while.

The situation is made even worse when we consider how many more of us will need such treatment in the future. At the moment, 700,000 people in the UK are suffering from Alzheimer’s and 120,000 from Parkinson’s, at a cost of £25,000 per year per patient. A study commissioned by the Motor Neurone Disease Association, to be completed by the summer of 2007, puts the cost of caring for someone with motor neurone disease in their final year of life at around £170,000. With around 1,600 people dying of MND each year, the total cost to the NHS and the social services is estimated to be more than £270 million a year.

More insidious than the economics is the human cost. For every one person suffering from degenerative disorders, let us say that there are 10 who care about that individual. Hence, by the middle of this century, as the numbers in the UK climb to around 2 million, we could be looking at 20 million lives that are completely devastated. So there is a huge and growing need—a need that is unmet by current treatments.

Stem cell therapy offers an exciting and realistic alternative. Stem cells can also offer a very valuable tool to gain a better understanding of the diseases themselves. The rationale is completely different from conventional treatments. The idea is not to treat the symptoms but to harness regenerative biological mechanisms, so that new cells are produced and ailing cells are supported by the natural chemicals

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they produce. This would amount to a true cure. It would not merely replace the chemicals that are lost as a result of cell death but actually replace the cells themselves, from the microscopic ball of some 200 that make up the early stage embryo.

Embryonic stem cells are extraordinary as they have the capacity to produce every single type of cell in the body. Many of the chemical and micro-environmental signals that determine their fate are now known. Thus we are able to make the type of cells that degenerate in Parkinson’s disease, and the different type of cells that are lost, in a different part of the brain, in Alzheimer’s. By introducing such cells into the appropriate environment within the brain, they will become those lost neurons.

What are the potential arguments against this approach? I shall restrict my comments to the often overlooked technical aspects. On the potential for immune rejection, this hazard can be overcome, as is being researched in Oxford, by immunotolarising patients or by immunosuppression. Such therapies have side effects but the risk-benefit ratio compared with that seen with conventional drugs is greatly shifted in favour of the therapeutic benefit.

A further potential problem is that stem cells in an uncontrolled state will proliferate and thereby constitute a tumour. To date, there is no clinical evidence that this has occurred with stem cell therapy and, in any event, strategies to overcome this problem are well advanced. For example, you can manipulate stem cells so that they only divide at a few degrees hotter than would normally be the case in the living brain. Another way would be to initiate cellular suicide genes if the implant attempts division.

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