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When it comes to detail, every site has to be looked at on its own merits, and it may well be, on the basis of the science, that one site is more valuable than a second site. The second site might be chosen above the first site because of other factors. If the first site is needed for commercial purposes and there seems to be no alternative, that may be the answer. However, if that is the case and it is being heavily used for commercial purposes now, the odds are that it will in any case be pretty degraded. Even so, there may well be sites of equal value and, at a detailed level, one will be chosen and another will not. However, that does not stop the Government trying to give us a better picture, or vision, of what the system will look like at the end of the process.
Finally, I come back to my amendment on the timetable. I listened carefully to what the Minister said and I will read it all very carefully. In a sense, we are back to the old problem that we always have with legislation—that is, on the one hand, what the words say in the Bill and, on the other, what the Government’s intentions are. When we look at legislation, we are always being asked to believe that the Government have good intentions, that everything in the world is wonderful and that the legislation is going to work. One of our jobs is to ensure that it will happen, even if there is a change of Government. I must be careful what I say, given possible changes of Government, but
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Amendments A115 to A117 not moved.
House resumed. Committee to begin again not before 8.33 pm.
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”.
“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—
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,
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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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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“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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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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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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