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n the 21st November 2007 the science of cloning suffered a mortal blow. In what was described as “an earthquake for both the science and politics of stem cell research”, cloning was supplanted by an ethically uncontentious method for obtaining the specialised stem cells that cloning had failed to obtain.1 On that day the Japanese scientist Shinya Yamanaka published his breakthrough of “direct reprogramming”: creating the equivalent of cloned embryonic stem cells from adult skin cells, never using women’s eggs and never creating or destroying embryos.2 “This is the Holy Grail - to be able to take a few cells from a patient and then turn them into stem cells in the laboratory,” said Dr Robert Lanza from Advanced Cell Technology in Boston.3 The clearest sign that a revolution was upon us was the headline: “Dolly creator Prof Ian Wilmut shuns cloning”. The great pioneer of cloning, who had brought the first cloned mammal to birth and who held the license to clone human embryos in the UK declared that he was abandoning the field he had founded: Instead, Prof Wilmut is backing direct reprogramming or “dedifferentiation”, the embryo-free route pursued by Prof Yamanaka, which he finds “100 times more interesting”… as well as “easier to accept socially.”4 In the same way, the other great pioneer of embryonic stem cell research deferred to the Yamanaka method. Professor James Thomson, the scientist who first discovered human embryonic stem cells in 1998, published a study on the same day as Yamanaka confirming

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Written by David van Gend that these new stem cells derived from human skin had every property of stem cells derived from embryos – but none of the ethical and political baggage.5 He told the New York Times it would not be long “before the stem cell wars are a distant memory... A decade from now, this (controversy) will be just a funny historical footnote,” Dr Thomson said. More work remains, but he is confident that the path ahead is clear. “Isn’t it great to start a field and then to end it?” 6 This insight that a field had ended and a new phase commenced in stem cell science was reinforced in a review of the Yamanaka revolution by Australian scientist, Professor Martin Pera. He was formerly director of embryonic stem cell research at the Australian National Stem Cell Centre, and his article, Stem cells: a new year and a new era was published in the leading scientific journal Nature in January 2008: Manipulating cells from adult human tissue, scientists have generated cells with the same developmental potential as embryonic stem cells. The research opportunities these exciting observations offer are limitless. The generation of induced pluripotent stem (iPS) cells through direct reprogramming avoids the difficult ethical controversies surrounding the use of embryos for deriving stem cells.7 Always the response was the same: this is marvellous science, and it gets rid of the social and ethical stress of obtaining eggs and exploiting embryos. The potential for this development to bypass the central ethical objection to cloning was recognized immediately by Professor Loane Skene, former Chair of the Lockhart Review which advised the Australian government in 2005 to permit cloning. On the day Yamanaka’s iPS cell research was published she told ABC radio: What this does is take away the

Dr David van Gend is a Toowoomba GP and national director of Australians for Ethical Stem Cell Research, www.cloning.org.au He has addressed legislators on stem cells and cloning in five Australian state Parliaments and in the US Congress.

step of using the egg and creating the embryo which is particularly ethically contentious and it offers the opportunity to get stem cells that are matched to a particular person.8 In that succinct statement, Professor Skene reminds us of the goal that cloning failed to reach – getting stem cells that exactly match the patient – and acknowledges that this new method not only attains that goal, but is free from ethical concerns. Here we see the chief Australian cloning advocate relieving cloning of its duties after only a year. If our Parliament had known in 2006 what we know now, legislation permitting cloning would never have been drafted, let alone passed. At that time most Senators and MPs believed that cloning was the one and only method to obtain special stem cells that were thought to hold great medical promise. But since November 2007 there is a new and proven alternative method. The compelling technical argument for cloning is gone, while the ethical argument against cloning remains - therefore the time is right to repeal the cloning provisions and resume the longstanding ban on the creation of human embryos solely for research.

peer reviewed • Repealing the 2006 cloning provisions would have no bearing on the 2002 laws to allow ES cell research on ‘spare IVF embryos’. Our association opposed the 2002 ES cell provisions, but we accept that legislators are not likely to revisit that decision. However, we expect there will be widespread goodwill and agreement to repeal that aspect of our laws which was always most divisive, and is now most clearly unjustified. In this way the current Senate and House of Representatives can heal the worst of the wounds in the public conscience over embryo research. They can tell a good news story to the Australian public: a once in a lifetime tale of scientific genius that has brought powerful science and human value back into alignment, instead of in conflict. There are those, however, who will not want research limited in any way by the conscience vote of a parliament. As our representatives reconsider cloning during the upcoming statutory review, defenders of cloning will argue two things, hoping to keep cloning on its futile life-support for a little longer: first, that cloning raises no great issue of conscience, because the cloned embryo is not really an embryo; second, that the new iPS cell science is not really an adequate alternative to cloning and we need to ‘keep researching everything’. This is the right time to forewarn and forearm those of our representatives who do not want to be misled in the way so many were in 2006. There are two points on which we need clarity: that cloning does indeed create a living human embryo destined solely for research and destruction, and that cloning is no longer necessary or justifiable in Yamanaka’s “new era” of iPS cell science. IT’S AN EMBRYO, STUPID Cloning is just another way of creating an embryo. It creates a person’s identical twin, which then grows just like any other embryo conceived naturally or by IVF. In the quest by cloning advocates in 2006 to dehumanise the cloned embryo, the most deceitful argument was that it is not really a human embryo, and therefore not deserving of special respect. The clone is just ‘cells in a

Petrie dish’, or ‘an intermediate cellular product’. If no embryo is really created, they argued, there is no big ethical deal – so let’s just get on with the research. Regrettably, as the Hansard record shows, this argument confused many Senators and MPs. That was despite Professor Loane Skene admitting, in her testimony to the Senate enquiry, that cloning does indeed create a human embryo – an entity which has the capacity, like any other embryo created naturally or by IVF, to grow as a baby: We did not shy away from calling it an embryo because it is conceivable, as happened with Dolly the sheep, that if that entity were put into a woman, after a lot of care, it could in fact develop into a foetus. So we did call it an embryo.9 An entity which “could in fact develop into a foetus” is nothing less, nothing other than a living human embryo. That is what is created by cloning, and that is why the 2006 legislation was such a momentous question of conscience. As this figure demonstrates, the cloned embryo (below) would be indistinguishable from an embryo created by fertilisation. Cloning (or SCNT) involves taking a woman’s egg from which the nucleus has been removed; transferring a new nucleus (a new genetic identity) from a donor’s cell; exposing the egg with its new nucleus to a range of stimuli and perhaps, after using a hundred eggs, one would respond as if it had been fertilised by a sperm and begin to develop and grow. The scientist would have created an identical twin embryo of the donor, and at a week of age it would be suitable for the extraction of stem cells from its inner cell mass – so destroying the embryo. For legislators to be comfortable about creating a laboratory subclass of human embryos, cloning advocates needed to

assure them that the cloned entity was inferior to other embryos. This strategy was an international one, and bioethicist Leon Kass, Chair of the US President’s Council on Bioethics in 2006, pleaded for honesty about the cloned embryo: If we are properly to evaluate the ethics of this research and where it might lead, we must call things by their right names and not disguise what is going on with euphemism or misleading nomenclature. The initial product of the cloning technique is without doubt a living cloned human embryo, the functional equivalent of a fertilised egg.10 This strategy of misleading nomenclature was adopted at the highest level – the International Society for Stem Cell Research (ISSCR). A scathing editorial in Nature entitled Playing the Name Game reported on the June 2005 meeting of the ISSCR and accused it of attempting “to change the definition of the word ‘embryo’” and “playing semantic games in an effort to evade scrutiny”: Whether taken from a fertility clinic or made through cloning, a blastocyst embryo has the potential to become a fully functional organism. And appearing to deny that fact will not fool diehard opponents of this research. If anything, it will simply open up scientists to the accusation that they are trying to distance

themselves from difficult moral issues by changing the terms of the debate.11

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Our Parliament is not a place for ‘name games’ designed to distance MPs from serious moral issues. Yet some representatives in 2006 still spoke as if cloning did not really create a human embryo – and perhaps our representatives will be misled by these fallacies again in 2010. The favourite of these fallacies was to argue that unless a sperm is involved, an embryo is not created. Cloning does not use a sperm to create an embryo; ipso facto it is not really an embryo! Never mind that Dolly the cloned sheep had no sperm involved in her creation, and without doubt started life as a perfectly adequate sheep embryo. Likewise Snuppy the puppy, sundry cows, horses and a dozen other mammalian species arising from cloned embryos, where no sperm was involved. One final semantic gimmick in 2006 was that the legislation was not really about cloning, but about ‘SCNT’. This bizarre piece of verbal trickery (since SCNT is merely the acronym for the actual process of cloning – ‘somatic cell nuclear transfer into an enucleated ovum’) was considered useful by strategists at the International Society for Stem Cell Research, and was also noted in Nature: At the equivalent meeting last year, the society decided to formally adopt the term ‘somatic cell nuclear transfer’ (SCNT)… Scientists realized that the word ‘cloning’ was generating public concern. So they decided to adopt a more technical term less likely to stir up strong emotions.12 Kass had a comment on this tactic too: Although as a scientific matter ‘somatic cell nuclear transfer’ (SCNT) may accurately describe the technique that is used to produce the embryonic clone, these terms fail to convey the nature of the deed itself, and they hide its human significance.13

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The cloning lobby felt they could distract the public from the human significance of cloning embryos by denying that a true embryo was created, by peddling the biological nonsense about sperm being necessary to create an embryo, and by using only the innocuous acronym ‘SCNT’ instead of ‘cloning’. The upcoming legislative review must be free of such attempts to hide the human significance of cloning, because that question of humanity is at the heart of this whole debate and must be squarely faced. The only reason we have a conscience debate on this issue is because the entity created by SCNTcloning, just like the entity created by natural fertilisation or by IVF, is, in truth, one of us - a human embryo. AFTER YAMANAKA: WHY CLONING IS UNNECESSARY The new post-cloning era of ‘induced pluripotent stem cells’ (iPS cells) was summed up in January 2008 by a leading Australian researcher, Dr Jack Martin, Emeritus Professor of Medicine at the University of Melbourne: In the past few months the scientific situation has changed dramatically in ways that should make therapeutic cloning a historical peculiarity. iPS cells have been shown to have all the properties previously attributed to embryonic stem cells, and thus provide a means of preparing individually tailored pluripotent cells without the ethical problems involved in therapeutic cloning. To this must be added the fact that iPS cells can readily be prepared, whereas human therapeutic cloning has never been achieved. If it ever had been, it is such an inefficient process that it would always have required unacceptably

large numbers of egg donations by women. There is no valid reason for any government to consider approval of therapeutic cloning that requires nuclear transfer into human eggs. Indeed, it would be prudent to have the 2006 federal legislation taken off the books.14 Every legislator needs to ponder Professor Martin’s succinct summary, and then ask the obvious question: What remaining justification is there for human cloning, given the success of the iPS cell alternative? Can any reasonable person take seriously this proposal: that I obtain hundreds of eggs from women and spend a vast amount of research money in order to clone you into your identical twin, in order to obtain pluripotent stem cells that will be a genetic match (something nobody has yet managed to

achieve) – when I could have simply taken a skin cell from your arm and achieved the identical stem cells easily, cheaply and ethically using direct reprogramming? Scientists are reasonable people, and their enthusiasm for cloning seems to have evaporated with the advent of direct reprogramming. How else do we explain that only one laboratory in the whole country – Sydney IVF – has even attempted cloning since 2006? And even this world leader in embryo manipulation, having obtained 352 precious eggs from IVF women, was not able to make any of the 27 resultant cloned embryos live long enough to yield even a single stem cell.15 It is the same story the world over: cloning is a blighted science, ethically and technically. The onus is on those who defend cloning to explain why such a convoluted and contentious path should

be taken when there is now such a straightforward alternative path. That question is so obvious that even the media are asking it – indeed, it made it onto Oprah! In a highly symbolic moment (in the presence of Michael J. Fox, Parkinson’s sufferer and prominent advocate for embryo research) Oprah’s resident expert, Dr Oz, asks why you would mess with embryos when you can simply reprogramme one of your skin cells: I think, Oprah, the stem cell debate is dead, and I’ll tell you why… The problem with embryonic stem cells is that they come from embryos, like all of us were made from embryos … In the last year we’ve made 10 years’ advancement… and here’s what the deal is: I can take a little bit of your skin (here he reaches over and touches Fox on the arm), take those cells, and get them to go back in time so they’re like they were when you were first made.16 Likewise Time magazine asks whether there is anything left to argue over since Yamanaka’s breakthrough: No embryos, no eggs, no handwringing over where the cells came from and whether it was ethical to make them in the first place. Yamanaka’s and Thomson’s work sidestepped that altogether, raising the tantalizing question, Is the long-raging stem-cell debate at last over? Yamanaka thinks it might be. Other giants of the field seem to agree.17 Yet not all will agree. People who have a lot to lose through the death of cloning – celebrity advocates like Fox and senior scientists who reject the idea of their research or their funding being restricted by Parliament – will not lightly accept an end to the stem cell debate. We know this, because we have seen it already in the two State jurisdictions which have debated cloning since the revolution of November 2007. The Parliament of Western Australia in early 2008 was convinced by the new science and rejected cloning in favour of Yamanaka’s ethical alternative. A year later, the South Australian Parliament appeared to be following WA, but a number of scientists persuaded

the MPs that Yamanaka’s “direct reprogramming” was not so impressive after all, and they had better just “keep all options open”. Their chief argument was that iPS cells are dangerous because direct reprogramming uses viruses and transcription factors in a way that might provoke cancer in human cells. That was an out-dated, untrue account of the science, but it did the trick. These senior scientists must have been aware that Yamanaka, six months earlier, had already shown that iPS cells can be created without any viral integration.18 Likewise several scientists – including James Thomson - have achieved iPS cell reprogramming without viruses and with no concern about iPS cells harbouring dangerous ‘oncogenes’.19 The second suggestion from the SA scientists was that iPS cells are not really the same as the ES cells one might get from cloning - therefore direct reprogramming cannot be said to have replaced cloning. Again, slippery words to impress MPs, but pioneering iPS scientists like James Thomson say ES cells and iPS cells are indeed equivalent: “The human iPS cells described here meet the defining criteria we originally proposed for human ES cells, with the significant exception that the iPS cells are not derived from embryos.”20 And just a few months prior to the SA scientists’ intervention yet another study found that in all the aspects studied: “human iPS cells are indistinguishable from human embryonic stem cells”.21 Those who would cast doubt on the ES/iPS cell equivalence will highlight a pair of articles from July 2010 which found that iPS cells appear to retain an epigenetic ‘memory’, for a while at least, of their cell of origin. That lingering imprint makes them slightly resistant to conversion into other cell types when compared to ES cells.22 But is this a relevant difference? No – because the “memory” fades as the iPS cell culture is allowed to mature and divide a little longer, leaving the iPS cells as responsive as an ES cell once more. A more recent review in August 2010 in Cell Stem Cell disputed the relevance of such subtle ES/iPS cell differences: “these variations did not serve to

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distinguish ESCs from iPSCs. We can’t yet prove that they are absolutely identical, but the available technology doesn’t reveal differences”.23 For all practical purposes, iPS cells do the job that ES cells from cloning were meant to do but failed to do. That is the established consensus. The claim that iPS cells and ES cells show significant differences is not supported by the evidence. MPs and Senators should be forearmed against attempts to diminish the new science of direct reprogramming - false arguments that iPS cells and ES cells are different in some relevant way, or that the iPS process uses viruses and thereby risks cancer. Yamanaka’s new science is a cause for celebration: the contentious science of cloning has been rendered irrelevant, and we can now all support medical research that gets us great benefits without threatening our humanity. STEM CELL SCIENCE IN SUMMARY: For research • All stem cells are useful for research, with iPS cells far more valuable than ES cells from IVF embryos since iPS cells alone are a genetic match for the patient. • Cloning has proven to be a failure for research, because there has never been even a single ES cell created by cloning. • iPS cell technology has successfully and uncontentiously created hundreds of stem cell lines that perfectly match patients with Parkinson’s, diabetes, muscular dystrophy etc.24 For treatment • Every human stem cell treatment you have ever heard of, without exception, has used adult stem cells (ASCs). Only ASCs can be placed in humans to regenerate tissue – because they exactly match the patient and do not form tumours. Thousands of humans have been given ASC treatments for dozens of conditions - including autoimmune diseases, bone repair, and heart attack.25,26 • No ES cell (whether from IVF or from cloning) and no iPS cell can

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“Yamanaka’s new science is a cause for celebration: the contentious science of cloning has been rendered irrelevant, and we can now all support medical research that gets us great benefits without threatening our humanity.”

•

EVER be put into a human being, because they form teratoma tumours in animals. See the statement on the ISSCR web site: “embryonic stem cells themselves cannot directly be used for therapies as they would likely cause tumors”.27 The proposed Geron Corp ES cell trial in spine injury would NOT put a single ES cell into any patient; it merely uses ES cells (from IVF embryos) to generate “mature” (but genetically foreign) nerve stem cells for transplant. But here is the obvious question:28 s. Since the same nerve cells could be readily generated from iPS cells, with the huge advantage that they would exactly match the patient - why use embryos at all? b. Since scientists have already published trials using a patient’s own adult stem cells in spinal injury, with no tumours formed – why use embryos at all?29 c. There is still a concern that the “mature” stem cells in this trial may revert to ES cell status and cause tumours; the trial is only a Stage 1 test to see if tumours occur.

•

Cloning was never a starter for direct stem cell therapies, since the ES cells it hoped to produce (but never has) would form tumours if placed in humans.

The end of the cloning era • There is no longer any valid reason to attempt cloning to create ES cells because the goal of “patientmatched pluripotent stem cells”, which cloning never attained, has been achieved by the iPS cell alternative. CONCLUSION Cloning is a human corruption and a scientific failure. In coming months, our federal parliament will hold a review of our national cloning laws. Since those laws were passed in 2006, science has undergone a revolution, and cloning has been made redundant by Yamanaka’s new science of direct reprogramming. Therefore the legislation that underpins cloning can safely be dismantled. We have the duty to repeal an unethical practice whose scientific justification no longer exists, and restore the longstanding prohibition on the creation of human embryos solely for research.

Report no. 50, Canberra, pp. C.9-10. 29. Productivity Commission 2009, Gambling, Draft Report, Canberra, October, p. 12.18 30. Productivity Commission 2009, Gambling, Draft Report, Canberra, October, p. 12.15. 31. Wardle, H., et. al., British Gambling Prevalence Survey 2007, National Centre for Social Research, 2007, p.19. 32. Wood, R.T. and Williams, R.J. 2008, Internet Gambling: Prevalence, Patterns, Problems and Policy Options. Final Report prepared for the Ontario Problem Gambling Research Centre, Guelph, Ontario, Canada, 5 January 2009, p. 10. 33. Wood, R.T. and Williams, R.J. 2008, Internet Gambling: Prevalence, Patterns, Problems and Policy Options. Final Report prepared for the Ontario Problem Gambling Research Centre, Guelph, Ontario, Canada, 5 January 2009, p. 10. 34. Wood, R.T. and Williams, R.J. 2008, Internet Gambling: Prevalence, Patterns, Problems and Policy Options. Final Report prepared for the Ontario Problem Gambling Research Centre, Guelph, Ontario, Canada, 5 January 2009, p. 10. 35. Wood, R.T. and Williams, R.J. 2008, Internet Gambling: Prevalence, Patterns, Problems and Policy Options. Final Report prepared for the Ontario Problem Gambling Research Centre, Guelph, Ontario, Canada, 5 January 2009, p. 12. 36. The Allen Consulting Group, ‘Review of current and future trends in interactive gambling activity and regulation’, Literature Review, June 2009, p. vii. Why Free Trade is Fair and Fairtrade is Not written by Tim Wilson 1. Panorama, 2010, “Tracing the bitter truth of chocolate and child labour”, BBC, London, United Kingdom, at http://news. bbc.co.uk/panorama/hi/front_page/newsid_8583000/8583499.stm 2. Gresser, C. and Tickell, S., 2002, “Mugged: Poverty in Your Coffee Cup”, Oxfam International, Boston, United States of America 3. Berndt, C., 2007, “Does fair trade coffee help the poor: Evidence from Costa Rica and Guatemala”, Mercatus Policy Series, Policy Comment Number 11, Mercatus Center, George Mason University, June, Arlington, United States of America, available at http:// mercatus.org/publication/does-fair-tradecoffee-help-poor-evidence-costa-rica-andguatemala?id=17688 4. Foreign Agricultural Service, 2010, “Coffee: World Markets and Trade: Record Brazilian and World Production Forecast for 2010/11”, United States Department of Agri-

culture, June, Washington DC, United States of America, available at http://www.fas.usda.gov/ psdonline/circulars/coffee.pdf 5. Weber, J., 2007, “Fair trade coffee enthusiasts should confront reality”, Cato Journal, v27, n1, Washington DC, United States of America, available at http://www.cato.org/ pubs/journal/cj27n1/cj27n1-9.pdf 6. Berndt, C., 2007, “Does fair trade coffee help the poor: Evidence from Costa Rica and Guatemala”, Mercatus Policy Series, Policy Comment Number 11, Mercatus Center, George Mason University, June, Arlington, United States of America, available at http://mercatus.org/ publication/does-fair-trade-coffee-help-poorevidence-costa-rica-and-guatemala?id=17688 7. Sidwell, M., 2008, “Unfair trade”, Adam Smith Institute, London, United Kingdom, available at http://www.adamsmith.org/images/pdf/unfair_trade.pdf 8. Weitzman, H., 2006, “The bitter cost of ‘fair trade’ coffee”, Financial Times, September 8, available at http://www.ft.com/cms/s/2/ d191adbc-3f4d-11db-a37c-0000779e2340. html 9. Fairtrade Labelling Organisation International, 2007, “Shaping global partnerships: Annual Report 2006/07”, Bonn, Germany, available at http://www.fairtrade.net/ fileadmin/user_upload/content/Final_FLO_ AR_2007_03.pdf 10. According to the Fairtrade Labelling Organisation total Australian sales of Fairtrade certified products totalled aroundAUD$40 million, see Fairtrade Labelling Organisation International, 2010, “Growing Stronger Together: Annual Report 2009-10”, Bonn, Germany, available at http://www.fairtrade.net/fileadmin/ user_upload/content/2009/resources/FLO_Annual-Report-2009_komplett_double_web.pdf 11. Letter to Tim Wilson from Bob Weymouth from the Australian Competition and Consumer Commission dated 2 July 2008. 12. Neil, C., 2008, “Free trade vs fair trade”, ABC Radio National Background Briefing, Radio transcript July 13, available at http:// www.abc.net.au/rn/backgroundbriefing/stories/2008/2297789.htm 13. Burress, C., 2002, “A great city’s people forced to stop drinking swill? Berkley ordinance would ban all but politically correct coffee”, San Francisco Chronicle, June 21, A-1 14. Global Exchange, 2007, “Advocacy Groups Persuade Procter & Gamble to Offer Fair Trade Certified Coffee: Largest US Coffee Company to Pay Farmers a Fair Price”, available at http://www.globalexchange.org/campaigns/fairtrade/coffee/Millstonevictory.html 15. Fairtrade Foundation, 2008, “Response to Adam Smith Institute Report”, United King-

dom, February 25, available at http://www. fairtrade.org.uk/press_office/press_releases_ and_statements/feb_2008/response_to_adam_ smith_insititute_report.aspx An obituary for human cloning written by Dr David van Gend 1. Rolands J, Centre for Genetics & Society, Oakland CA at http://sciencenow.sciencemag. org/cgi/content/full/2007/1120/1 2. Yamanaka article at http://www.cell.com/ retrieve/pii/S0092867407014717 ; breaking story at http://www.nytimes.com/2007/11/21/ science/21stem.html?_r=2&ref=science&oref =slogin&oref=slogin 3. Dr Lanza comments at http://www.abc. net.au/news/stories/2007/11/21/2096427. htm?section=world 4. Prof Wilmut on abandoning cloning at http://www.telegraph.co.uk/science/sciencenews/3314696/Dolly-creator-Prof-IanWilmut-shuns-cloning.html 5. Thomson article at http://www.sciencemag. org/cgi/content/abstract/318/5858/1917 6. Prof Thomson interview at http://www.nytimes.com/2007/11/22/science/22stem.html? _r=2&adxnnl=1&oref=slogin&adxnnlx=1200 529650 -3udVJCSOq5dSjn2cdoCJw 7. Pera MF. Stem cells. A new year and a new era. Nature. 2008 Jan 10;451(7175):135-6. 8. Prof Loane Skene comments re Yamanaka at http://www.radioaustralia.net.au/news/stories/ s2096987.htm 9. Loane Skene on cloning creating an embryo quoted at Senate Inquiry CA 112 at: http://www. aph.gov.au/hansard/senate/commttee/S9811.pdf 10. Kass in New York Times, May 29th 2005. 11. Nature 436, 2 (7 July 2005) | doi: 12.1038/436002b 12. Nature, ibid. 13. Kass, ibid. 14. Prof Martin, The Australian Jan 17th 2008 at http://blogs.theaustralian.news.com.au/yoursay/ index.php/theaustralian/comments/amen_to_ death_of_embryo_research 15. Cloning in Australia, see Report Feb 2010 of the NHMRC Embryo Research Licensing Committee. 16. Oprah interview at ~ 2min 30: http://www. oprah.com/media/20090319-tows-dr-oz-brain 17. TIME, The Year in Medicine Dec 2007 at http://www.time.com/time/specials/2007/article/0,28804,1685055_1686349,00.html 18. “Virus-free” iPS by Yamanaka at http://www. sciencemag.org/cgi/content/abstract/1164270 19. “Virus-free” iPS by James Thomson at http://www.sciencemag.org/cgi/content/abstract/1172482 and by Kaji at http://www. nature.com/nature/journal/v458/n7239/full/

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nature07864.html and by Ahmad at http://www. physorg.com/news175458227.html and by Zhou at http://www.eurekalert.org/pub_releases/2009-04/sri-amb042209.php 20. Yu J et al. (Thomson), Induced Pluripotent Stem Cell Lines Derived from Human Somatic Cells, Science published online 20 November 2007, doi: 10.1126/science.1151526 21. ES cells and iPS cells “indistinguishable” at http://bloodjournal.hematologylibrary.org/cgi/ content/abstract/blood-2009-02-204800v1 22. “Memory” in iPS cells at http://www.nature.com/nature/journal/vnfv/ncurrent/full/nature09342.html and http://www.nature.com/nbt/ journal/v28/n8/full/nbt.1667.html 23. ES cells and iPS “virtually identical” at http://www.physorg.com/news200224498.html Guenther MG et al., Chromatin Structure and Gene Expression Programs of Human Embryonic and Induced Pluripotent Stem Cells, Cell Stem Cell 7, 249-257, 6 August 2010 24. iPS cell lines achieved by mid-2009 http:// ethicalstemcellresearch.blogspot.com/2009/05/ for-scholars-ips-journal-references-up.html 25. ASC treatment references at http://www.sciencemag.org/cgi/data/315/5810/328b/DC1/1 26. ASC in heart attack at http://content.onlinejacc.org/cgi/content/abstract/54/24/2277 27. ISSCR ‘Top 10 Things to Know about Stem Cell Treatments’ at point 2 http://www.closerlookatstemcells. org/Top_10_Stem_Cell_Treatment_Facts.htm 28. ES cell-derived trial (Geron Corp) at http://ethicalstemcellresearch.blogspot. com/2009/11/geron-and-on-and-on.html and http://www.washingtonpost.com/wp-dyn/content/article/2010/08/29/AR2010082901854. html?sid=ST2010082305519 29. Spine injury ASC trials at http://www.nature.com/sc/journal/v47/n10/abs/sc200924a. html and http://www.ingentaconnect.com/content/cog/ct/2008/00000017/00000012/art0000 1?token=0057156e9168a7e442f2067214876 6c777b492b45427a636876275045416762492 66d656c185ee1dce5572d and http://www.media.wayne.edu/2009/10/16/study-shows-adultstem-cell-grafts-increased Legal regulation of human cloning and embryo research: the forthcoming review Written by Professor Loane Skene 1. Prohibition of Human Cloning for Reproduction Act 2002, viewed 27 August, 2010, http://www.comlaw.gov.au/comlaw/Legislation/ActCompilation1.nsf/0/29E1194B14703C BDCA257528000D8E69/$file/ProhibHumanCloningforRep2002_WD02.doc; Research Involving Human Embryos Act 2002, viewed 27 August, 2010, http://www.comlaw.gov.au/ comlaw/Legislation/ActCompilation1.nsf/0/1

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4870B2084551C48CA25752700815BE0/$fi le/Research+Involving+Human+Embryos+A ct+2002_WD02.doc 2. Note 1 above. 3. For example, in Jewish ethics, an embryo is apparently regarded as an embryo only when implanted in a woman’s uterus; until implanted, it is regarded as a ‘pre-embryo’ which may be used in research: Steinberg, Professor Abraham ‘Jewish medical ethics: May humans play God?’, lecture, Oxford, 1 June 2010. 4. Legislation Review: Prohibition of Human Cloning Act 2002 and Research Involving Human Embryos Act 2002, viewed 27 August, 2010, http://www.nhmrc.gov.au/_files_nhmrc/ file/research/embryos/review/legislation_review_reports_full_doc_19dec05.pdf 5. Prohibition of Human Cloning for Reproduction Act 2002; Research Involving Human Embryos Act 2002, note 1 above. WA did not amend its legislation. 6. Reed, Don, ‘Overturn Dickey-Wicker Abomination, or Forget Stem Cell Cures for a Generation’, Huffington Post, 26 Aug 2010, viewed 27 August, 2010, http://www.huffingtonpost. com/don-c-reed. 7. Wren, Kathleen, ‘Cellular Reprogramming Leads Science List of Top 10 2008 Breakthroughs’, Am. Association for the Advancement of Science, 18 December, 2008, viewed 27 August 2010, http://www.aaas.org/news/ releases/2008/1218breakthrough.shtml. 8. Panizzo, Rachael, ‘DNA difference between stem cell types found’, BioNews, 12 April, 2010, viewed 27 August, 2010. http://www.bionews.org.uk/page_57804.asp. Another report put a more positive view: ‘[I]f a similar gene signature [to the one found in these mice] is found in human cells, it could help researchers to identify which iPS cells to avoid using, and which stand the best chance of producing the desired tissue’: Dolgin, Elie, ‘Gene flaw found in induced stem cells’, (2010) 464 Nature, 663. doi:10.1038/464663ª, viewed 27 August, 2010, http://www.nature.com/news/2010/100331/ full/464663a.html?s=news_rss. 9. See, press release of National Institutes of Health, ‘First Human Embryonic Stem Cell Lines Approved for Use Under New NIH Guidelines’, 2 Dec, 2009, viewed 27 August, 2010, http://www.nih.gov/news/health/ dec2009/od-02.htm. 10. The U.S. based company Geron Corporation received federal approval in January 2009 from the US Food and Drug Administration (FDA), after extensive safety evaluation, to undertake clinical trials for human patients using neuronal precursor cells derived from human ES cells to treat spinal injury. The trials were deferred for further tests on animals but the

FDA said in July 2010 they could proceed. In the trials, the cells will be inserted into ‘the lesion site of the patient’s injured spinal cord’: News release of Geron Corporation, ‘Geron to Proceed with First Human Clinical Trial of Embryonic Stem Cell-Based Therapy’, 30 July 2010, viewed 28 September 2010, http://www. geron.com/media/pressview.aspx?id=1229. See also, note 28 below. 11. Katsnelson, Alla, ‘US judge puts temporary block on human embryonic stem cell research’, 23 August, 2010, viewed 27 August 2010, http://blogs.nature.com/news/thegreatbeyond/2010/08/us_judge_puts_temporarly_ block.html. 12. Ertelt, Steven, ‘Appeals Court Allows Obama to Fund Embryonic Stem Cell Research During Suit’, 9 Sept 2010, viewed 27 September 2010, http://www.lifenews.com/ bio3169.html. 13. Isasi, Rosario M; Knoppers, Bartha M, ‘Monetary Payments for the Procurement of Oocytes for Stem Cell Research: In Search of Ethical and Political Consistency’, (2007) 1 Stem Cell Res 37, 39. 14. Siemaszko, Corky, ‘$10,000 is an Egg-cellent Price, Says Stem Cell Panel’, Daily News, 26 June 2009. 15. Connor, Steve, ‘UK won’t fund hybrid embryo studies’, The Canberra Times, 6 Oct, 2009. 16. ‘A Stem Cell Success Story - UK Stem Cell Biologists Help to Deliver a New Bronchus for Claudia Castillo’ (author not given), UK National Stem Cell Network Newsletter, Winter 2008, at 8, viewed 27 August, 2010, http:// www.uknscn.org/downloads/newsletter_winter08.pdf. See also a later case in the UK: Laurance, Jeremy, ‘British boy receives trachea transplant built with his own stem cells’, (2010). BMJ 340, c1633. 17. ‘Groundbreaking Stem Cell Surgery Gives Boy New Cheekbones’, Good Morning America (undated)., viewed 27 August 2010, http://abcnews.go.com/GMA/OnCall/ experimental-treatment-boy-cheekbones/ Story?id=8804636&page=2 18. Lister, Sam, ‘Stem Cell Therapy Reduces Symptoms of Multiple Sclerosis’, Times Online (UK), 30 Jan, 2009, viewed 27 August 2010, .http://www.timesonline.co.uk/tol/life_and_ style/health/article5614644.ece. See also Burt, Richard K. et al, ‘Autologous Non-Myeloablative Haemopoietic Stem Cell Transplantation in Relapsing-Remitting Multiple Sclerosis: A Phase I/II Study’, 8 The Lancet Neurology 244 (2009), viewed 27 August, 2010, http:// download.thelancet.com/pdfs/journals/laneur/ PIIS1474442209700171.pdf (describing in detail the above-mentioned study).