Health: Stem Cell Therapy

Question for Short Debate

7.33 pm

Tabled By Lord Alton of Liverpool

To ask Her Majesty’s Government what additional resources they are allocating to developing therapies using adult stem cells.

Lord Alton of Liverpool: My Lords, as we return to a question that I have raised previously in your Lordships’ House, and which we discussed during the passage of the Human Fertilisation and Embryology Act 2008, I thank all noble Lords who are participating in tonight’s short debate.

On 19 November 2001, I brought a team of scientists to give oral evidence to the Select Committee on Stem Cell Research. In our joint submission we said that,

“it is now abundantly clear that adult stem cell research shows more clinical promise than embryonic stem cell research”,

and that it holds none of the moral dilemmas or hazards. After years of pouring resources into embryonic stem cells, one small glimmer of hope came, just a year ago, when £0.6 million was offered to existing Medical Research Council grant-holders to support small projects with induced pluripotent stem cells-iPS cells. Despite Professor Shinya Yamanaka’s seminal paper published in Japan almost three years ago, nobody in Britain had hitherto published any work in this area. For too long, we have been stuck in a blind alley.

The wisdom of the MRC’s 2008 investment was illustrated by the announcement on Sunday last that Dr Keisuke Kaji at the University of Edinburgh and a colleague from Toronto have been among the first to get human skin cells to act like embryonic stem cells without needing to use viruses, and with the introduced genes successfully removed after reprogramming. As the MRC says on its website, research teams now state that,

“their discovery could ultimately spell an end to the need for human embryos as a source of stem cells”.

I emphasise that statement. Bearing in mind the endless days that we spent last year being told that work with animal-human hybrid embryos was of paramount importance, it is also worth noting that in January the Medical Research Council turned down at least the first two applications for hybrid embryos as not worth funding. We should not be surprised by that. As long ago as July 2005, an editorial in Nature Biotechnology admitted:

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“Of course, it will be many more years before cloned ES cells can be turned into routine clinical treatments for patients”.

It went on to say:

“Meanwhile, forward steps continue to be made in the field of adult stem cell therapy. One estimate is that there are currently over 80 therapies and around 300 clinical trials underway using such cells”.

I repeat: 80 therapies and 300 clinical trials. Three years later, we still have no stem cells at all from cloned human embryos, never mind “routine clinical treatments” based on cloning. This sharply contrasts with the burgeoning number of treatments using adult stem cells.

So, to what extent has government funding for stem cell research over recent years been an accurate reflection of what is currently benefiting patients? In a press release on 13 September 2007, the Medical Research Council announced that it would be providing a total of £760,000 in funding specifically so that women at Newcastle would receive financial inducements to provide their eggs for cloning. This sponsored egg-bartering in order to create and destroy embryos was already highly questionable on multiple ethical grounds. However, I found it all the more baffling in the light of the oral evidence given to the House of Commons Science and Technology Committee by the chief executive of the MRC earlier that same year, when he said:

“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”-

I repeat: the virtually zero success rate-

“in using that technique, at least for somatic nuclear transfer, so far”.

Given that the chief executive of the MRC expressed such strong doubts about human cloning with eggs from women, why on earth did he and the MRC then take the extraordinary step of sanctioning the effective purchase of women’s eggs at Newcastle “as an exceptional case”? If this is an exceptional case, what have been the exceptional benefits of this research? Perhaps the Minister, when he comes to reply, can tell us.

The House should contrast this approach with the work of Professor Geoffrey Raisman, director of the Spinal Repair Unit at the University College London Institute of Neurology. He leads a research team whose work could ultimately lead to the repair of spinal cord injuries in humans. An estimated 40,000 people in the UK live with spinal cord injuries, and his team’s work offers significant hope that such patients will eventually be able to regain much lost movement and even the restoration of the lost ability to breathe unaided. He has been working for well over a decade on a method for the repair of spinal cord injuries by transplantation of cells cultured from the upper part of the adult nasal lining. This approach is similar to that already used by Dr Carlos Lima of Portugal-I hosted a meeting on his behalf in the Moses Room of your Lordships’ House a couple of years ago-to treat individual patients with spinal cord injuries that occurred between six months and six years previously. I might add that Dr Lima has never used human embryos to facilitate his work.

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It is worth noting that Professor Raisman’s pioneering work remains underfunded. He told me that his work with adult stem cells is,

“struggling month by month to survive”.

In addition to inadequate funding, he says that to develop further the real promise held out by his research it will also be necessary to support properly regulated clinical trials. He contrasted his approach with that of Geron, which wants to use embryonic stem cells but only in patients who sustained spinal injuries within the previous fortnight. Professor Raisman told me:

“Over 40% of patients who are paralysed when they are admitted to hospital will walk out of the hospital and there are very few indicators to tell you which are the 40% and which will be the 60%. If Geron’s patient trials are to assess the safety of the transplanted cells they should be used with patients who have long-standing injuries”.

That is precisely what Professor Raisman is himself doing. I hope that the Minister would agree with that view.

Professor Raisman has also expressed concern that the media hype over embryonic research as a coming miracle cure has put adult stem cell research programmes in the shade. These are his words:

“Adult stem cells are much more promising therapeutically; they are already in use for such things as skin grafting, but they attract less funding and much less interest because they can’t be patented”.

The use of patents is an issue that we need to think very carefully about, given that they can be used to create commercial success for companies such as Geron, whereas adult stem cells do not carry the same kind of commercial benefit.

Unlike some proponents of embryonic stem cells, Professor Raisman certainly does not want to raise false hopes for desperate patients. Although his work has shown so much promise for more than a decade, he told me:

“I can’t guarantee success, we are climbing a high mountain but this is a realistic approach”.

Although he is himself agnostic on questions about the status of the human embryo, he believes that human embryonic research holds back medical progress by attracting funds that might otherwise go to adult stem cell work. These are his words:

“The scramble to fund human embryonic stem cell experiments looks like the scientific equivalent of sub-prime mortgages. One wonders how long the large sums of money and hype can go on chasing such a distant goal before the bubble bursts … Patients have for some years been putting ever increasing faith in the curative properties of embryonic stem cells far beyond anything justified by any current knowledge or treatments. The attraction of human embryonic stem cells lies less in their therapeutic than in their imagined commercial potential-but is this justified by the science?”.

Despite that apparent folly, Professor Raisman told me that in contrast with speculative corporations, he remains a scientific idealist. He said:

“No patient that I am privileged to help will ever be charged a penny. My work is not about patents and trying to capitalise or exploit suffering”.

I put it to him that perhaps the problem was that adult stem cells are seen as having Cinderella status. He disagreed, saying, “No, Cinderella didn’t die of starvation”. That is what he says is happening to adult stem cell research. Surely this is what we should all strive to

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support first and foremost: good science and good ethics marching hand in hand. Rather than pouring resources into the scientific equivalent of sub-prime mortgages, in Professor Raisman’s striking phrase, our public policy priorities should reflect his enlightened approach. Once again, I thank all noble Lords who will speak this evening.

7.43 pm

Baroness Morris of Bolton: My Lords, I am most grateful to the noble Lord, Lord Alton, for securing this short but important debate. My interest in adult stem cell research was born out of a terrible accident that happened to the newly married son-in-law of some of my dearest friends. On a moonless night in the Brecon Beacons, while on exercise with the Army, he fell over a cliff and was paralysed.

Some months later, the family read in the newspapers of pioneering research being carried out at UCL by the very professor of whom the noble Lord, Lord Alton, spoke so knowledgeably, Professor Geoffrey Raisman, in which the spinal cord of a rat had been repaired using cells from the nasal cavity. Although Professor Raisman said that there was a long way to go and that he did not wish to raise false hopes in patients living with spinal cord injury, his work indicated that the spinal cord had the ability to repair itself and that the next logical step was human trials. He also said in the article that that work would open the door to treatment of other conditions where nerve fibres are damaged, such as some major forms of stroke, and blindness and deafness caused by nerve injury. With great anticipation, my friends contacted Professor Raisman. His reply shattered their hope. He said that they were a long way from human trials and that he did not even have enough money to buy next year’s rats.

We are nearly four years on from then and I had sincerely hoped that the situation had changed but, listening to the noble Lord, Lord Alton, I realise that it has not. In October last year, one of the UK’s leading authorities on adult stem cell research, Professor McGuckin, who, with his team, pioneered working on stem cells from umbilical cord blood, said that he was leaving to work in France because there is not enough support for his work here.

However, such strides are now being taken in the field. In November, groundbreaking collaborative work by researchers and surgeons across Britain, Italy and Spain gave 30 year-old Claudia Castillo a new section of her windpipe created from stem cells collected from her bone marrow. Several months later, Claudia is apparently fit and well, with no signs of her body rejecting the graft. Professor Martin Birchall at the University of Bristol, who led the team that constructed the windpipe tissue, said:

“Surgeons can now start to see and understand the very real potential for adult stem cells and tissue engineering, to radically improve their ability to treat patients”.

The construction of the windpipe makes it now the second organ produced outside the body using stem cells from the patient’s own body.

In 2006, a team from Wake Forest University School of Medicine in North Carolina, led by Professor Anthony

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Atala, revealed that it had fitted seven children with bladders reconstructed from their own tissue. Professor Atala said:

“We have shown that regenerative medicine techniques can be used to generate functional bladders that are durable”.

He went on to say that that suggests that regenerative medicine may one day be a solution to the shortage of donor organs for those needing transplants.

A number of other early clinical trials around the world involve adult stem cell therapy-for example, for Parkinson’s disease, stroke, heart attack, multiple sclerosis and type 1 diabetes. My father had multiple sclerosis; I suffer from a chronic auto-immune condition; and many of my friends and their families live lives horribly affected by illness. Therefore, I fully understand the desire to find treatments, but I worry that the work in adult stem cells is losing out.

I must make it clear, as part of the opposition Front Bench, although I am speaking from the Back Benches tonight, that I am not asking for more money. I am asking what percentage of moneys available for research into stem cells goes into adult stem cell therapy. At what stage do the powers that be look at the overall picture and, however much may have been invested in embryonic research, including academic pride, say that we need to redress the balance? I am not a scientist, but common sense would seem to say that through adult stem cell research we can make a real difference to patients’ lives and we can make it now.

7.48 pm

Baroness Williams of Crosby: My Lords, the noble Baroness, Lady Morris, has given a moving account of individual cases affected by some of the work done on adult stem cells. If I may say so, what she had to say was something that we need to ponder carefully.

We have now had long discussions in this House on the subject of human fertilisation and embryology research. One thing that has come through very clearly is that there is a very strong received opinion in the scientific community. I should declare a distant interest as having been once been a Minister for science. I came across that received opinion on a number of other issues of controversy within science. There has now been a sustained received opinion that embryonic stem cell research is more valuable and is likely to prove to be more effective than other kinds of research into stem cells, despite the growing evidence-and it is powerful growing evidence, as the noble Baroness, Lady Morris, and the noble Lord, Lord Alton, said-that adult stem cell research is leading to far more effective therapies than are associated with embryonic stem cell research. Indeed, the most recent figure indicates that some 80 effective therapies have come out of the study of adult stem cells, and not a single one, unless the Minister would like to name it, has so far operated at the level of being an effective therapy from embryonic stem cell research.

Why, then, is so much adult stem cell research starved for lack of money? There are two arguments for that. One is what I have already mentioned: the received opinion, widely held in the scientific community in Britain-not outside to the same extent-that this is the right way to go. So strongly held is that opinion that the House will recall that when we discussed

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the Human Fertilisation and Embryology Bill in 2007, we were pressed to consider and indeed support the idea of research into hybrid embryos as a way of dealing with the chronic shortage of human eggs. So far, research into hybrid embryos has proved a very dead alley indeed. Dr. Lanza, reporting recently with the support of one of the outstanding laboratories in the world, Advanced Cell Technology Inc in Los Angeles, indicated that there was almost no future, apparently, in the use of hybrid cells. To use his words, there was evidence that the use of human oocytes-human embryos-in hybrid connections with animal oocytes-animal embryos-had so far shown no ability to get beyond 16 cells, when it effectively died off.

However, we have pursued it, and one has to ask why the Medical Research Council and other research councils have decided that they will not pursue, too far, the use of hybrid embryos. I think that the answer is clearly given by what the noble Lord, Lord Alton, said. You cannot patent human adult stem cells, recovered from the human himself or herself. They have, of course, the huge advantage of not involving any immune reaction. They are accepted by the body because they come from the same cell structure as the body. Then one has to ask why it has proved so difficult for research laboratories to get the extra expenditure that they need. The evidence is clear: the inability to patent this kind of stem cell research makes it much less attractive to the pharmaceutical profession and the scientific establishment.

I hope that the Government will take my concluding remark into account. I strongly support the question asked of the Minister by the noble Baroness, Lady Morris, about what proportion of research money in the past year has gone to adult stem cell research from the research councils and for research overall. Given the astonishing steps being taken in this area of research, one moment’s consideration will tell us that the savings to the National Health Service alone-if adult stem cells prove to be an effective way of dealing with a very wide range of conditions, as is now emerging-would be well into the millions of pounds and possibly beyond. One of the commercial considerations has to be the cost to the taxpayer of this country of sustaining research that requires patents that have to be paid for. That is necessary, and I am not against it; NICE has taken that kind of development into account. But why do we not take advantage of the huge savings that would be made to the National Health Service of research that does not require to be patented and which I would regard as a major benefit to this country and to its citizens? I think that the House has not considered that factor adequately, and I ask the Minister whether he has considered it adequately.

7.54 pm

The Lord Bishop of Southwell and Nottingham: My Lords, I, too, encourage the Government to put more funding into research and clinical trials with adult stem cells and to avoid wasting precious resources on more dubious work.

I should like to pick up on the comments of the noble Lord, Lord Alton, about the £760,000 in funding from the MRC specifically to provide cut-price IVF in

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exchange for eggs for cloning. Many of the women would not be able to afford private IVF but would be desperate to have children and would therefore be in a very vulnerable position.

I also admit to being somewhat confused about the purposes of this research as described by the group now receiving substantial MRC funding. As I understand it, the original aim of the cloning licence granted to the group at Newcastle, led by Professor Alison Murdoch, was ostensibly to use patient-matched embryo stem cells to treat people with diseases such as type 1 diabetes. This was clearly stated, for example, in the Lancet in June 2004 and in New Scientist in August 2004. What did not seem to have been addressed, however, was the fundamental question of how cloning could possibly help an auto-immune disease such as type 1 diabetes. Notably, Sir Ian Wilmut, whose father suffered from diabetes, commented that,

“transfer of immunologically identical cells to a patient is expected to induce the same rejection”.

The aim was subsequently revised prior to the granting of a licence by the HFEA instead to use cloning for non-specified therapeutic ends. I am not sure how something unspecified can be “necessary and desirable”-the requirements for awarding a licence. However, in an interview broadcast by the BBC after the award of the licence, Professor Murdoch then said that they could use cloning to,

“make pancreatic cells that make insulin, inject them back into the patient and then effectively that could cure their diabetes”.

When news first broke regarding reports of a cloned human embryo created at Newcastle, Professor Murdoch stated,

“if you’ve got a child with diabetes who is 10 years old, then I think we are realistically looking at something which will help them in the future … We’ve shown that it will work in humans. So it is now a realistic option that we will have treatments in the not too distant future”.

Well, it is perfectly clear that we still have no cure for diabetes from cloning, and it is doubtful in the extreme whether one ever would.

I must be frank: I am appalled that certain people, who have been recklessly raising false hopes such as these, should have been considered as an exceptional case for funding by the MRC. If government funding bodies are interested in developing a cure for diabetes, I would encourage them to invest elsewhere. Promising work has already been performed in this area by Julio Voltarelli and Richard Burt, who used immunosuppression and transplantation of stem cells from the bone marrow of patients with newly diagnosed type 1 diabetes. This apparently restored the function of insulin-producing cells in all but one patient, seemingly rendering a majority of the patients insulin-independent. Of course, this is still a preliminary trial, but it would surely seem to have a better chance of truly helping diabetics.

There is also the work of Professor Faustman from Harvard, who has used a similar approach in altering the immune system to treat type 1 diabetes successfully in animals. Will the Government consider supporting the funding of similar research and clinical trials for diabetes sufferers in the UK?

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Cloning, however, has been touted as a miracle cure for just about everything from diabetes to Alzheimer’s. For example, in speaking about the purported outcomes of her work, Professor Murdoch of Newcastle told the BBC:

“it can help just about any condition in which there is lost or damaged cells. Diabetes, Alzheimer’s, Parkinson’s, spinal injuries … the list is almost endless”.

How realistic is that? The chance of Alzheimer’s being cured by stem cells was described by Ron McKay, an eminent Scottish stem cell researcher working in America as “a fairy tale”. Similarly, the noble Lord, Lord Winston, previously expressed concern about popular suggestions for treating Alzheimer’s. He said that it was,

“going to be a hugely difficult problem and probably completely insoluble by stem cells”.

As regards spinal injuries, the noble Lord, Lord Alton, has already highlighted the very encouraging work by Professor Raisman, which has seemingly been sorely neglected. Even if there were some genuine benefit to stem cell research from human cloning, this has surely been superseded by advances with iPS cells, such as those which we heard about at the start this week. Cloning research is simply wasting precious resources that would be better spent on genuinely promising and perhaps less ethically compromised research.

Cloning in Newcastle should not have been made an exceptional case for funding by the MRC so that vulnerable women undergoing risky procedures are offered financial inducements, in order to obtain as many eggs as possible for cloning. I strongly encourage the Government to make greater funds available for studies with adult stem cells and clinical trials, so that patients can benefit as soon as possible. I look forward very much to the Minister’s summing up.

8 pm

Lord Patten: My Lords, I strongly agree with everything that the right reverend Prelate has said, in particular when he raised the flag of warning against scientific hype, a matter to which I shall return in the three points that I will make.

My first point is a straightforward question to the Minister. It is my perception-which is, perhaps, wrong-that the Government seem deeply biased against promoting and funding research into the use of adult stem cells, which have been producing results, compared to all the money spent on embryonic stem cell research, which has not produced results. I well remember, as will other noble Lords, my discussion across the Chamber with the noble Lord, Lord Darzi, who is not in his place tonight. I asked him to name, in a straightforward way, any successful outcomes from stem cells. The noble Lord was good enough to say that so far he had nothing to report. My perception is that the Government are prejudiced against work on adult stem cells.

Does the Minister, with his distinguished business and City background, not recognise that there can sometimes be a pell-mell and ruthless rush by competitive scientists for funds, matched by equivalent government support for embryonic stem

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cell research? There is nothing wrong with competition; I like competition. However, we may-returning to the point that the right reverend Prelate has just made-see the scientific equivalent of a much-hyped asset or stock market bubble, exactly like the heady, but eventually headless, days of the dotcom boom. It is a bubble that will collapse in exactly the same way, having wasted a lot of money. I choose the word “waste” very carefully.

Secondly, I think the ground, in public opinion, is beginning to shift away from the miracle cures of foetal stem cell research. We are just beginning to see the first signs of that change. In the research recently published inNature by the team from Edinburgh to which the noble Lord, Lord Alton, referred, we begin to see people saying, “Should we not spend our money on something that is pragmatic and real today, rather than much-hyped hope for, perhaps, tomorrow?” Again, the right reverend Prelate pointed this out. Is the Minister aware of just how much recently-and it is only really since Christmas and the new year-commentators’ opinions have begun to reflect this sea change in public opinion?

I do not want to shock any of my noble friends on this side of the House, let alone cause my noble friend Lord Bates any fear that I might be wobbling, but I have recently taken to reading both the New Statesman and theGuardian. I had better ‘fess up to both. I do this, first, because the New Statesman kindly sends its latest issue to me at the House, totally free each week, so it seems only polite to read it. I did so on 22 January this year, when it opined:

“As the adult cells come from the patient’s own body, the cells are not amenable to the imposition of intellectual property rights … Both governments and industry (the pharmaceutical industry) are loath to invest or fund unless they can see the prospect of intellectual property rights”.

Quite so; this is exactly the point that the noble Baroness, Lady Williams of Crosby, made. The Guardian then stepped into the argument on 2 February, thundering:

“There is no market for the drug companies to exploit, and no market means no commercial funding”.

It goes on to say that, as a result, these advances in adult stem cells “may founder”. I find myself agreeing with the Guardian.

I end with my third point. I have raised a flag of warning, as did the right reverend Prelate, that we may see a bubble in front of us. I have also suggested that public and press opinion are changing. All Governments respond to this; whether Labour or Tory, we all listen. Thirdly, I remind the Minister that he is not, in the Government, “cloneable”. He is, in the proper sense of the word, in a unique position-because of his own experiences-to understand and deal with this situation and put it right. In the pharmaceutical world, the Minister has a notably distinguished record as someone who, with his scientific background, promoted the growth of a highly successful company, which did a lot of good for patients. I congratulate him on that. My City colleagues tell me that the company made excellent profits and repaid both investors and management handsomely, which was richly deserved. I applaud everything that the Minister has done.

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However, I understand that the advances made in his companies depended on the patentability of intellectual property rights being properly exploited. The Minister knows how much more difficult-indeed, impossible-it is to attract development capital equity injections when advances do not have this valuable intellectual property in them. It is only to the Government and to the Minister that those in this important world can turn for help, either for the money that is needed or for suggestions of where those companies should go for that money.

Baroness Thornton: My Lords, I remind noble Lords that the last three speakers have run one minute over their allotted time. When the clock clicks to five minutes, the speaker’s time is up.

8.06 pm

Lord Patel: My Lords, if I were able to answer some of the points raised by the last few speakers, I would probably need 30 minutes, but I do not have that; I have just been reminded that I have even less. I am not going to defend one type of stem cell research or another; nor am I going to speak for or criticise any of the stem cell researchers who might or might not have been mentioned, whether their work is bona fide or not. First, I declare an interest. I am a member of the Medical Research Council. I am also a fellow of the Academy of Medical Sciences and vice-president fellow of the Royal Society of Edinburgh. I hope to give a balanced view of where stem cell research is going, what needs to be funded and what does not. It is important to understand that in stem cell research there are some key fundamentals.

Stem cell science is a fast-moving field, as evidenced by the recent publications of Professor Austin Smith from Cambridge in the journal Development; by Keisuke Kaji from the Regenerative Medicine Centre in Edinburgh, who is also a fellow of, and funded by, the MRC; and by Andras Nagy, from Toronto, in Nature. Their research has led to obtaining induced pluripotent stem cells without using viral vectors. That is a fantastic advance that may one day result in the development of therapy for a large number of patients, not only one or two being treated by autologous adult stem cells. The problem with adult stem cells when they are used for autologous treatment is that they are good for one patient at one time. They do not have immune challenge, but they cannot be used to treat a large number of patients.

The promise lies in either embryonic stem cells or induced pluripotent cells, which are adult cells, delivering that promise one day. That is why it is important to note that, despite the success, it is not clear at this stage which strand of stem cell research-adult, embryonic or induced pluripotent-will yield the best treatments. It may well be that different stem cell types are required to treat different diseases. We do not know yet. It is also true that it was science worked on in embryonic stem cells that delivered yesterday’s publication on induced pluripotent cells without using any viral vectors.

The UK’s strict but facilitating regulatory framework allows for all forms of stem cell research. This broad-based

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approach allows for cross-fertilisation between subdisciplines of stem cell research.

As for funding, on the whole the best research gets funded. In 2007-08 the MRC spent £25 million, 61 per cent on adult stem cell research and 39 per cent on embryonic stem cell research. BBSRC, the biological science research council, spent £12.3 million, 31 per cent on adult stem cell research, 42 per cent on embryonic stem cell research and 27 per cent on research using unknown, but possibly adult, stem cells. The Wellcome Trust spent £3 million, 85 per cent of that in adult stem cell research. The total Research Council spend was £36 million and the total government spend was £61 million. In 2008, the MRC and the BBSRC pump-primed 13 groups to work on induced pluripotent stem cell research.

On 17 April 2009, the MRC will hold a workshop to strengthen the UK’s induced pluripotent stem cell science. A new MRC funding scheme for stem cell research of £10 million per annum by 2010-11 will be for translational research. In January 2009, the MRC awarded £3 million to address barriers to progress in preclinical stem cell research. The MRC has just signed a MoU with the California Institute of Regenerative Medicine whereby the CIRM will allocate $210 million and the MRC $5 million for 10 programmes of preclinical trials in four years-in any stem cell types that will take us to the treatment of diseases such as diabetes, Parkinson’s and other debilitating diseases. The MRC and the British Heart Foundation jointly call for developing centres in cardiovascular stem cell biology. In addition to the EPSRC, various disease-based charities also contribute significant amounts of funding.

I have no time to tell the what the current stem cell research is directed towards, but I can tell noble Lords that the balance is more or less 50/50, if not more towards adult stem cell research. Many of the world’s leading experts on IPSC are scientists who also work on embryonic stem cells. The major centres of excellence in stem cell research, including Cambridge and Edinburgh in our country, also work in adult stem cell research and embryonic stem cell research.

I end by congratulating the scientists on the work published recently, which shows fantastic progress in induced pluripotent stem cell research by British-based scientists. The broad approach to stem cell research offers the greatest promise for medical advances. Let the best science be funded and, it is to be hoped, soon we will find treatments for many debilitating diseases.

8.12 pm

Baroness Barker: My Lords, I, too, thank the noble Lord, Lord Alton, for the opportunity to make a few points.

First, will the Minister confirm that proportionate MRC funding for adult stem cell research has increased? In 2004 it was 51 per cent and in 2007 it was 61 per cent, so it is increasing. Secondly, will the Minister assure the House that government policies will uphold the Haldane principle that scientific research should be within specific programmes, and that individual projects should be approved on a case-by-case basis based on the quality of the science rather than by politicians? Does he agree that it is not insignificant

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that Professor Stephen Minger, one of the foremost researchers in this country working on embryonic stem cells, recently had a research proposal turned down using that principle?

The noble Lord, Lord Alton, is a strong advocate of adult stem cell research and he repeatedly uses the phrase that, while adult stem cells hold out great hope, there have been no therapies derived from embryonic stem cells. That is true, but I ask him whether he will concede today that adult stem cell therapies have been with us since the 1950s; that embryonic stem cell research has been with us since the 1990s; and that, given the normal scale of academic research, it is highly unlikely that there will be any therapies at this stage? It takes a minimum of 10 years to get from the point of basic research to the point where a therapy can be developed. When the noble Lord makes that comment so insistently, it is important that he should place it in its full context.

Having said that, will the noble Lord also acknowledge that Geron, a company in the US, has just had permission for embryonic stem cell therapy research on acute spinal cord injuries to be carried out, and that in London the team led by Professor Peter Coffey is about to start early clinical trials of treatment for macular degeneration?

The noble Lord, Lord Patel, is much more able to deal with the scientific aspects of this debate than I and he is right to say that this is a fast-moving field. It is right to refer noble Lords to our debates on the Human Fertilisation and Embryology Bill, when many of us conceded that there have been enormous and exciting breakthroughs in the field of adult stem cell research, but the scientists involved in those breakthroughs have themselves conceded that their work would not be possible without all of the research that has gone on, and which continues, into embryonic stem cells. The two need to co-exist. Even Professor Yamanaka is on record as saying that his work is dependent on that work.

Other noble Lords and I came to understand, particularly during the passage of the HFE Bill, that research science is not linear; it is not a straightforward process. It is a process of pure research and therefore it can produce the unexpected, which can lead to breakthroughs which inform others in different branches of science and different disciplines.

I ask the Minister whether he has taken to heart some of the points made by the noble Lord, Lord Patten. There can be fads and trends in commercial funding but it is always the job of government to make sure that essential science is funded long before it ever gets to the point of translational research or research which is close to becoming a therapy. It is the duty of government to make sure that research continues on all fronts. I say to the noble Lord, Lord Alton, that it is not only adult stem cell researchers who are short of money; other scientists are equally short of money and dependent on charitable funding.

We are at the point of an enormous breakthrough and potential, but it will only come to fruition, to the point where therapies are developed, if we continue to push forward on all fronts. I seek assurances from the Minister that that is what we will do.

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8.17 pm

Lord McColl of Dulwich: My Lords, I also thank the noble Lord, Lord Alton, for introducing this debate. I am particularly pleased that adult stem cells are doing so well. Nearly 30 years ago I worked with a team at Guy’s Hospital led by Dr Matteo Adinolfi. We used foetal stem cells to treat children with Hunter or Hurler syndromes, which are fatal diseases due to the congenital lack of two essential enzymes associated with mucopolysaccharides. The foetal stem cells were derived from the amnion membrane, which is part of the afterbirth, and were immunologically privileged since they did not express histocompatibility antigens and therefore would not be rejected. We hoped that if we transplanted them into these patients, they would produce the missing enzymes. Like the king’s cup bearers of old who tasted wine to make sure it was safe to drink, we operated on ourselves to make sure this procedure was safe. We inserted pieces of amnion membrane under the skin of our arms and then re-operated a few months later to confirm that they had not been rejected. We then inserted fresh amnion into these children and small quantities of the missing enzyme were produced with some initial improvement. We were, however, always worried about the danger of inducing cancer; hence our pleasure at the success of transplanting adult stem cells which are safe and free of histocompatibility antigens. These advances seem to put a question mark over the initial enthusiasm for the use of foetal stems and hybrids, as the noble Lords, Lord Alton and Lady Williams, have already mentioned.

A review article last year on page 937 of issue 451 of Nature drew attention to laboratory experiments and recent clinical trials suggesting that adult stem cells derived from the bone marrow of a patient can be used to improve the function of the heart of that patient and may well be used to prevent or even reverse the progression of heart failure. This was confirmed by that splendid rational and scientific Cochrane organisation, which published a systematic review of the medical and research literature on this subject last October. What are the Government doing to support this promising therapy for heart failure, which is, after all, the leading cause of death worldwide? The UK Stem Cell Foundation charity is funding a clinical trial at University College London, but this is only one trial. Are the Government aware of any other trials in this country to understand and improve such therapeutic benefits?

In a review article in the Journal of the Neurological Sciences, Professor Neil Scolding at the University of Bristol draws attention to the immense and invaluable experience which haematologists have gained about the collection and delivery of bone marrow cells and their excellent safety record. Notably, in decades of delivering such cells to bone marrow transplant recipients, there has been no evidence of donor-derived malignancy. This contrasts with the risks of the much hyped embryonic stem cells, where transplantation of even a small residual population of undifferentiated cells can produce a tumour. It is well known that the long-term culture of human embryonic stem cells can cause them to gain or lose large sections of chromosomes, which further raises the spectre of cancer.

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Recently, a small study led by Professor Richard Burt in Chicago indicated that stem cell transplants may control and even reverse multiple sclerosis symptoms if carried out early enough. In a paper published last month, he describes how patients with relapsing-remitting multiple sclerosis had stem cells transplanted from their own bone marrow. Not only did none of them deteriorate over three years but 81 per cent of them improved by at least one point on a scale of neurological disability. Moreover, none of the 21 adults deteriorated over a three-year period. So will the Government be turning more of their attention to funding the much more promising and safe adult stem cell research and development?

8.22 pm

The Minister of State, Department for Innovation, Universities and Skills (Lord Drayson): My Lords, I thank the noble Lord, Lord Alton, for securing this debate. As I have said on several occasions before, although we may disagree in this House and elsewhere on some issues, the ability of this country to debate the challenging ethical issues that underpin stem cell research-and, from that, the derivation of a carefully considered and highly effective regulatory system-has contributed in no small part to this country’s leadership in stem cell research. This House has contributed magnificently to the development of that regulatory system.

It is no stretch to claim that the United Kingdom is the leader in stem cell research. The work, much of it funded by the Medical Research Council and the Biotechnology and Biological Sciences Research Council, is a testament to the quality of that research. Vitally, it gives many people new hope that the diseases and conditions from which they suffer will be treatable in the future, as was so eloquently described by the noble Baroness, Lady Morris.

It is therefore important for me to say why we believe the UK has been able to achieve that global leadership and, as I do so, to answer the noble Lord’s questions and concerns in this area. First, as I have said, we have encouraged a full debate and developed a sense in this country that the public’s ability to engage with this complex science is a model for many other areas of science. As Science Minister, I turn to the debate over stem cell research as a great example of the way that challenging ethical issues in science should be debated. We have public confidence in our scientists and vice versa, which strengthens the case for research of this kind.

Secondly, through such debate, including the recent approval by this House of the Human Fertilisation and Embryology Act, we have created an effective regulatory regime that other countries seek to emulate, particularly the United States, following the changes being put in place by President Obama. Most leading UK and international research centres work on all stem cell types. At the same time, no one can carry out any embryo research without a licence from the HFEA, in answer to the direct question asked by the noble Baroness, Lady Barker.

The third strength in this area, which underpins all our scientific research in this country, is our adherence

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to the Haldane principle that decisions about research projects are made on the basis of excellence in research by peer review by the scientific community, underpinned by the independence of the research councils, as eloquently described by the noble Lord, Lord Patel. I am happy to confirm that the Government will stick to the Haldane principle; we regard it as underlying our success. It is unfair and incorrect to accuse the Government of having any sense of moral bias or any interference from Ministers in the selection of projects relating to stem cell research.

I note the concerns regarding whether or not the scientific community, in this area and in others, goes too far in raising expectations. That is a reasonable concern. It is important for the scientific community, particularly in these areas of significant unmet medical need, to be careful in the way that it communicates the potential of its science. I note the point made by the right reverend Prelate the Bishop of Southwell and Nottingham, and I will write to noble Lords about my understanding of the specifics of the Newcastle case.

Scientists are clear that we need research into all forms of stem cell research to generate the breakthroughs in understanding that will translate into potential treatments. The scientific community’s current understanding is that the best chance of progress will come from the cross-fertilisation of knowledge through research into all stem cell types. It is important to highlight, as the noble Lord, Lord Patel, just did, that recent breakthroughs in induced pluripotent stem cells, although representing an important scientific breakthrough, would not have been possible without the research that has taken place on other cell types.

This is an area where UK scientists are again leading the way, as we saw from the announcements over the weekend. However, it is much too soon to assess the clinical impact of this development; IPS cells remain very much at the proof-of-concept stage, and it will be some time before it will be possible to consider developing them into clinical testing. A number of problems will need to be overcome before that can be contemplated.

The situation remains that human embryonic stem cells remain the cells with the greatest potential for achieving progress in disease treatment at present. That is because they are truly pluripotent whereas adult stem cells have a restricted ability to form different cell types. They present fewer safety issues, since embryonic stem cells are not engineered and contain chromosomes with less damage or modification.

Noble Lords asked a number of questions on the issue of funding. I was grateful to the noble Lord, Lord Patel, for his enumeration of funding as part of research council support in this area. I want to state clearly that the balance of funding is not, as has been questioned, biased against adult stem cells-quite the contrary. As the House has heard, within the MRC, for example, 61.3 per cent of funding goes towards adult stem cells versus 38.7 per cent, and that is increasing. The overall balance is 50:50, broadly speaking; it is slightly towards adult stem cells. However, I see no evidence at all for any bias against this cell type.

Stem cell and regenerative medicine are a strategic priority for UK public funding. I absolutely accept the point made by a number of noble Lords, including the

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noble Lord, Lord Patten, that there is a very important role-a vital role-for support by government of fundamental research, particularly where it may not be possible to achieve patenting of the cell types, and where that fundamental research underpins the potential for breakthrough across the piece. That is why we are funding all types of stem cell research and why we have significantly increased our backing for stem cell research, rising from £30 million in total in 2005-06 to more than £60 million in 2007-08.

This is not just about the research councils. We are also funding the process of innovation and the Technology Strategy Board, supporting several industry-led projects worth over £30 million, with public-sector funding worth over £10 million within that. Competition for public funding is strong. Although competition for funding in science is generally highly competitive, as noble Lords have said, this Government have significantly invested in funding for science, more than doubling the science budget over the past 11 years. Recently, in his speech on Friday, the Prime Minister reiterated that we will be continuing to support science as the ladder by which this country can get itself through and out of this economic downturn. We will therefore continue to maintain these substantial investments in science despite the downturn.

I am grateful to the noble Lord for highlighting my background working in the biotechnology industry. I declare that interest. I worked for 10 years grappling with the challenges of the commercialisation of medical research, with its long gestation periods and very high chances of failure in development. He and other noble Lords are absolutely right to highlight the fundamental importance of intellectual property and the ability to patent breakthroughs to give investors the opportunity to make an adequate return. However, there are areas in medical science where it is not possible, and it is right that it is not possible, to patent certain aspects. In my experience, however, there is the potential through consideration of the application of techniques to develop the patent estate in support of the development of a breakthrough new technology. We have seen good examples in the past, through orphan drug status or other mechanisms, whereby it is possible for very high quality research to receive funding and to be taken through development.

In concluding, I want to stress two points that are relevant not only to the successful development of stem cell research in this country but to science research more widely. One is continuing this Government’s absolute focus on funding scientific research on the basis of excellence. We have recently seen data which show that our scientific research is the most productive within the G8. The reason for that is the way in which we have managed scientific research over the past 11 years.

The second point, alongside the importance of a focus on scientific excellence, is to develop science literacy in this country and an open and clear debate about issues which present challenging ethical questions. We know that the public have legitimate concerns about the use of stem cells, especially embryonic stem cells, in both research and treatment. That is why we have funded the Sciencewise programme to carry out

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the largest ever public dialogue on stem cell research in the UK. The results of that exercise, published in December last year, clearly show high levels of public support for both stem cell science and technology, from basic research through to development. It shows that the public are keen for the UK to continue on the path it is following and that they feel that the balance is broadly right. I share the public’s wish for us to concentrate on research that has the potential to treat diseases which are currently causing such suffering world-wide, but to do so on the basis of the excellence and independence of our scientific community.