Take heart! ESCs are a dud, but ASCs continue to kick goals.

Right on cue, a day after Geron gives up tinkering with embryos, another report from the US of adult stem cell therapy for humans with heart failure.

Read about it or listen to it HERE at the ABC World Today.

I don't want to dampen the excitement, but of course we have had adult stem cell treatment for humans with heart failure for a decade or so - for example, an article in the Journal of the Americal College of Cardiology HERE. Nevertheless, this latest pair of studies is particularly good.

A conference in Florida has heard that two separate trials of stem cell therapy in humans have been surprisingly successful in replacing damaged muscle and getting the heart to pump better. The Heart Foundation says it could completely revolutionise the way heart failure is treated...

The first study used stem cells from the marrow:

We saw some of the hearts pumping better and patients able to walk further, but the most impressive result of this trial really are the clinical events, or what we call MACE - which stands for major adverse cardiac event - and what we saw was that there was a significant decrease in these adverse clinical events including death, requirement for revascularization procedures and heart attacks in these patients.

The second study used a patient's own heart stem cells (multiplied up and reinjected to the damaged area of heart muscle):

In the study these cells boosted the heart function by about 15 to 20 per cent and they also were also able to reduce the area of heart muscle damage by about 25 per cent. So these are findings never seen before.

I trust the significance of these two news events is not lost on our science reporters! Truly ESCs and cloning are dying a lingering and unlamented death, while ASCs for therapy are the most exciting thing in medicine today.

Puff, puff, "POP" goes the Geron ESC bubble!

What a bunch of clowns at Geron Corp - massaging the share price over the decade with each new announcement of impending ESC therapies (see the comic collation HERE) and then dropping their bogus ESC experiment for spinal injury half way through a phase 1 trial (remind yourself about that HERE).


Geron announced yesterday that they are closing their spinal-injury trial to new enrolments, and laying off most of their staff in that area now, with the rest going by mid-2012. Too bad for the existing patients with a spine full of potentially tumorigenic ESC-derivatives... Geron hopes some other company will take over their "stem cell assets".

The media release of 14th November states:

The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.

That means their ESC-derivative experiments are not promising enough to even complete the earliest-stage trial, despite all the ludicrous hype they and their media puppies propagated last year.

No doubt some government-funded body will take up these sort of futile experiments using dumb public money (futile and dumb becaause anything an ESC-derivative can do an ethically uncontentiuos iPSC-derivative can do better - because it matches the patient; even better, in spinal injury an ASC therapy would both match the patient and avoid the danger of tumours).

But in the real world, smart private money will continue to see through the hype and hoax of embryo stem cell "therapies".

RIP Geron's ESC fizzer.

Confirmation: cloning has NOT produced a single patient-matched stem cell

The question was raised, from the cloning review in this month's Quadrant, as to whether last month's Nature report means our claim is now out of date, where we said: "Cloning, for all the millions spent worldwide and all the blighted human entities created and destroyed, has failed to obtain even a single pluripotent stem cell."

The answer is still no. Human cloning has still not achieved any useable pluripotent stem cell - for two reasons. First, the experiment in Nature was not true cloning - the 'Dolly' technique, creating an identical twin embryo for patient-matched stem cells - but the creation of a triploid amalgam of the donor's and the mother's nuclear DNA. The resultant genetically-mutilated embryo contains a fatal extra set of chromosomes. Second, the experiment might have been tweaked to the stage of stem cells, but these are entirely unuseable stem cells as far as "therapeutic cloning" goes. It is a new form of abuse of the human embryo, but it does not qualify as achieving cloning's goal of pluripotent stem cells that match the donor.
For clarification, here is an article by AESCR researcher, Richard Egan, with thanks to Mercatornet where it was published last month, at this LINK.

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In an article published in Nature on 6 October 2011, Scott Noggle and his colleagues at the New York Stem Cell Foundation Laboratory report on their experiments in which they have derived stem cells from human embryos created by adding the nucleus of a somatic cell to a human egg.

The fact that the stem cells were useless made no difference to the amount of publicity this latest human cloning experiment received, but the reports did draw attention again to the supply of human eggs for the research and the ethics of paying women to undergo risky superovulation.

The process used was a form of cloning. However, in standard cloning – the technique used to produce Dolly the sheep – the nucleus is removed from an egg and replaced with the nucleus from a somatic cell. In the New York experiments it was first found that this process routinely fails with human eggs, with development of the human embryo created by cloning arresting before reaching the stage at which stem cells can be extracted.

The experimenters tried leaving the nucleus of the egg in place and merely adding the nucleus from the somatic cell. It appears that this left in place some factor in the egg that is crucial to the continued development of the human embryo.

However, as a result of leaving the nucleus of the egg in place while adding the nucleus of a somatic cell was that each cell of the resulting human embryo, including the extracted stem cells, is triploid – having 69 chromosomes rather than the normal human complement of 46 chromosomes.

This means that this experiment has not achieved the goal of obtaining patient-matched stem cells by cloning or “oocyte reprogramming” as some prefer to call it these days.

The triploid cells obviously don’t match the patient’s DNA and could not be safely used in therapies. Nor are they likely to be of any use for drug testing.

Nonetheless, with cloning research otherwise stalled around the world this experiment is likely to refuel the search for a way to make cloning for human embryonic stem cells work.

The New York experimenters do have a significant advantage over other cloning researchers. The Empire State Stem Cell Board in March 2010 approved contract policy conditions that allowed researchers to pay “women donating oocytes solely for research purposes … out-of-pocket expenses, including payments for travel, housing, medical care, child care and similar expenses incurred as a result of the donation of the oocytes for research purposes and compensated for the time, inconvenience and burden associated with the donation.”

This policy enabled the New York Stem Cell Foundation Laboratory to pay 16 women to procure (the word donate seems inappropriate when payment is being made) a total of 270 fresh eggs. This is an average of nearly 17 eggs from each woman.

New York is the only jurisdiction in the world to allow payment for egg procurement for research from women who are not undergoing egg retrieval for reproductive purposes.

Superovulation, which women undergo to produce eggs in this quantity is dangerous carrying a mortality risk of between 2.52 (UK 2003-05) and 6 (Netherlands 1984-2008) per 100,000. Professor Emerita of Sociology, Dianne Beeson, has given evidence to a US Congressional hearing on the dangers that egg extraction for cloning poses to women’s health and life. Up to 14 percent of patients undergoing superovulation experience some form of ovarian hyperstimulation syndrome, or OHSS. Common symptoms of mild OHSS include abdominal discomfort, ovarian enlargement, nausea and vomiting. Those who develop severe OHSS may experience a wide range of serious conditions including loss of future fertility, kidney or multiple organ failure, and death. The frequency of severe OHSS is estimated to be as high as 10 per cent of women who undergo the procedure.

The recent Heerey review of Australia’s cloning legislation recommended in June 2011 that there be no change to the current system in Australia where women can be reimbursed for reasonable expenses in relation to egg donation but that this does not include compensation for time or loss of income. The recommendation was particularly welcome as review committee member Professor Loane Skene had been a public advocate for Australia following New York’s approach to compensation for women for undergoing the procedure of egg retrieval. Perhaps it was just as well that this review had reported before the New York experiments were reported and the results could be hyped to justify the benefits of paying women for their eggs.

Sydney IVF which holds the only three licenses for cloning issued by the NHMRC Licensing Committee relies on obtaining eggs from women undergoing IVF. As of 28 February 2011 they had used 435 “clinically unsuitable eggs” in cloning experiments but failed to obtain development beyond the compact morula stage.

The licenses were set to expire on 16 September 2011 but on 24 August 2011 the NHMRC Licensing Committee extended the licenses until 16 September 2012. This is a disappointing decision in the light of the failure of the experiments to date and the obvious unsuitability of “clinically unsuitable eggs” as research material as already established by researchers at Newcastle in Britain and elsewhere.

The Heerey review in its majority recommendation that the law continue to allow licenses for cloning for research to be issued noted that:

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT [somatic cell nuclear transfer – the main cloning technique] research in animals and humans.

The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT

It is difficult to see how the NHMRC Licensing Committee could justify extending the Sydney IVF cloning licenses in the light of this recommendation.

However, it should be clear by now that different rules apply to cloning. Meaningless experiments are hyped as dramatic advances and snake oil salesmen are given a welcome mat and millions of dollars of funding.

QUADRANT ARTICLE: "Cloning - the Blighted Science"

If your weekend reading does not already include a rollicking obituary for the brief and unlamented era of human cloning, I have a full review in the new Quadrant magazine which is available online HERE.

The article arises from the Legislative Review earlier this year into Australia's cloning laws - that Review was an opportunity for us to rethink (re-pent) the abuses formerly legislated, even on the pragmatic grounds that newer science renders cloning redundant. As expected, however, the majority of the committee members argued for the status quo - the "yes, cloning has been a dud so far and yes, Yamanaka's method seems to have achieved what cloning could never achieve - but let's just research everything anyway " approach - and thereby the Review recommendations save face for those scientists and social progressives who invested so much energy in this battle of the culture wars back in 2006.

The subheadings of the article are: End of an Era; Humans Second Class; Fraud & Fairy Tales; Reality Check on Embryos; Death Throes; The 2011 Review: Clinging to Cloning.

Cloning is a human desecration and a scientific failure. It has always been unethical, in that it creates human embryos with their destruction in mind; it is now also clearly unnecessary. The Senate vote was carried in 2006 by the argument that cloning was the only possible way to obtain “pluripotent stem cells” that perfectly match the patient. That argument lies in shreds, in part through the failure of cloning to produce results but above all through the discovery of an alternative stem cell technique which is both effective and ethically uncontentious.

"Human cloning law: on the way out?" - Guest Blog.

Guest Blog by Richard Egan, research officer with the Coalition for the Defence of Human Life in WA. Richard prepared a comprehensive submission to the cloning review for the Coalition which can be viewed at: https://legislationreview.nhmrc.gov.au/sites/default/files/submissions/cdhl-sub-cloning-human-embryos-legislation-review.pdf 

Richard has recently returned from a series of conferences and meetings with bioethicists in the US. We are grateful to him for letting us post this clear summary of the key points of the recent Legislative Review.
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Human cloning: on the way out?

A recent review of the law permitting human cloning for research is less than enthusiastic about cloning and admits the law may soon be outdated.

In 2002 both Houses of the Commonwealth Parliament voted unanimously to prohibit all forms of human cloning, including cloning for research. The overwhelming consensus was that it was ethically wrong to create a human embryo for the purpose of destroying it in research, including research involving the extraction of embryonic stem cells.

A majority of both Houses did, however, support legislation which permitted the use of so-called “excess” human embryos, fertilised in vitro for reproductive purposes but never implanted, to be used for research, including the extraction of embryonic stem cells.

In 2005 a review of this legislation by the Lockhart committee coincided with the six month period between the much celebrated claim by Korean scientist Hwang Woo Suk to have successfully created several human embryonic stem cell lines from cloned human embryos and the revelation that this claim was fraudulent.

Based largely on the perceived need for Australia to catch up with the (fraudulent) Korean developments the Lockhart committee recommended changing the law to permit human cloning for research.

Despite the setback of Hwang’s fraud being exposed proponents of human cloning successfully hyped the possible results from such research to persuade a bare majority of one in the Australian Senate that legislation permitting human cloning for research was the best hope that the lame would soon walk, the blind see and the diabetic discard his or her insulin supplies.

The new law permitting cloning was assented to on 12 December 2006 and came into effect six months later in July 2007.

Heerey review

The report of the review of the new legislation by a committee chaired by former Federal Court judge the Hon Peter Heerey QC was released by the Gillard government on 7 July 2011.

The past four years has not favoured the proponents of human cloning.

The report observes:

Attempts to generate human ES cells by SCNT have been pursued for over seven years and, with the notable exception of work reported from Korea and subsequently admitted to be fraudulent, are yet to produce a claim to development of a human ES cell line, though development of embryos to the eight cell stage has been achieved.

A majority of the committee did recommend that the scheme permitting human cloning for research under license continue while commenting:

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT [somatic cell nuclear transfer – the main cloning technique] research in animals and humans.

The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

Committee member the Rev Fr Kevin McGovern strongly dissented from this recommendation noting:

the approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’

Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells.

Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSClines.

Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

The report noted that fellow committee member Dr Faye Thompson “shares Reverend McGovern’s concerns about SCNT”. So only three of the committee’s five members fully endorsed the recommendation – including known cloning advocates Professors Loane Skene and Ian Frazer who had each played a key role in the 2006 hype for cloning.

The report notes that of the total number of 264 submissions, 188 were from the general community. Of these, 112 specifically commented that they did not support human cloning, while all 188 stated that they did not support the use of human embryos for research.

In its final recommendation the report calls for a further review of the legislation each five years commenting that:

The Review Committee thinks it highly desirable that in this rapidly changing field of science there be periodic reviews. For example, it may be that by the time of the next review it has become accepted that SCNT is no longer appropriate.

Other recommendations

The Heerey committee unanimously recommended that there be no change to the legislation which prohibits payment for eggs or sperm. This was noteworthy given the very public campaign of committee member Professor Loane Skene for such a change.

The committee also rejected a proposal to change the legislation to allow the creation by fertilisation of human embryos with genetic inheritance from more than two people. Proponents claim this could help women with mitochondrial disease have children unaffected by the disease.

The majority of the committee also recommended allowing experimental research in creating human embryos using sperm or eggs derived by manipulating body cells or embryonic stem cells [in vitro derived or IVD gametes] . This technique could ultimately be used to create a child from sperm and an egg derived from a single individual or from two persons of the same sex.

Fr McGovern again dissented observing that:

the development of knowledge about human IVD gametes will lead almost inevitably to their use in human reproduction, even if many in our society are opposed to this.

The committee rejected calls from the Coalition for the Defence of Human Life and other community organisations to repeal the provisions in the law permitting the use of eggs from aborted baby girls to make human embryos for research.

In what can only be described as a lack of moral imagination the committee could not see anything to distinguish this abhorrent practice from other forms of making human embryos for research (such as cloning) or from the donation of tissue from aborted babies for other purposes. While these practices are all unethical surely there is something particularly repulsive to human and moral sensibility in making an aborted baby girl a mother only to cannibalise her offspring for speculative research.

Fr McGovern is to be commended for his forthright dissent and astute comments throughout the report. On the fundamental question of using any human embryos as a source for stem cells, including those “excess” to IVF requirements he states: 

Section 8 of the NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research requires that embryos which must be disposed of should be disposed of respectfully.

He does not believe that the evisceration of these embryos to extract their stem cells is respectful disposal. As we would be concerned if this was done to a human being at any other stage of human development, he believes that we should be concerned about this.

Indeed.

The Coalition for the Defence of Human life will continue to work for an end to all legislation that permits destructive research of any kind on any human embryo.

Media Release: Cloning left on Futile Life-Support (Legislative Review)

“The Legislative Review tabled yesterday (July 7th) is a lame attempt by the majority of this (outrageously stacked) committee to keep the blighted science of SCNT/cloning on its futile life-support” said Dr David van Gend, national director of Australians for Ethical Stem Cell Research. “Section 5.3 showcases the shriveled case for cloning, with only ardent supporters of cloning (Muncie, Williamson, Elefanty) being quoted in the section and no critics quoted at all. As expected, this one-sided chorus culminates in the stale old slogan of the ethically indifferent: "let's just research everything".

“However, even the majority position – including prominent cloning advocates Ian Frazer and Loane Skene - admits to the increasing difficulty of justifying any SCNT/cloning experiments at all, given the failure of cloning and the success of its ethical alternatives:

The Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT

“The dissenting opinion by Kevin McGovern, Director of the Caroline Chisholm Centre for Health Ethics (and the report states “Dr Kaye Thompson shares Reverend McGovern’s concerns about SCNT”) is a masterpiece of clear thinking and demolishes the ramshackle apologia of the dominant committee members.

In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

“McGovern has shown the way forward for an ethical society. Shame on Minister Mark Butler who, as our association predicted, cynically delayed tabling the cloning review until the last day before the long winter recess, about 6 weeks after the date the report was put on his desk. That means Senate critics like Barnett, Fielding and McGauran are gone, and Butler ensured the Review would not be examined until a safely libertarian Greens party held the balance of power in the Senate. Under a fair-minded Senate cloning would fall; it has always been unethical and now it is clearly unnecessary, as McGovern shows. The case for cloning is now so diminished that it could never carry a conscience vote like it did in the hysterically hyped days of 2006.

“Perhaps that means the vile project of creating human embryos solely with their exploitation and destruction in mind will linger as a stain on the statutes until the wresting of control of the Senate from the Greens. However, my hope is that Labor and the Coalition will unite against the Greens to turn off the futile life-support on this blighted science”, Dr van Gend concluded.

QUOTE FROM REVIEW:


END quote

Recommendation 3: (by majority) The provisions in the current legislation regarding SCNT should not be amended.

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

The foregoing represents a majority view of the Review Committee. Reverend Kevin McGovern, however, notes:

The approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’ Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT?

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells. Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSC- lines. Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

No fizz left in the cloning bottle: Legislative Review finally released

As predicted, Minister Mark Butler delayed tabling the cloning review until today, about 6 weeks after the due date for tabling in Parliament (27th May, which was in fact the date the report was put on his desk). That means potential Senate critics like Barnett, Fielding and McGauran are gone, and a safely 'progressive' Greens party holds the balance of power in the Senate.

Getting to the substance of the report, and for this post limiting it to the central question of cloning: a reading of the relevant section (5.3) shows the lame attempt by the majority of the committee to keep this sickly science on its futile life-support. This section was largely an apologia for the residual shrivelled case for cloning, with only ardent supporters of cloning (Muncie, Williamson, Elefanty) being quoted in the section and no critics quoted at all. As expected, this one-sided chorus culminates in the stale old trope of the morally menopausal: "let's just research everything".

Nevertheless, I detect throughout this report the bracing presence of Rev Kevin McGovern, Director of the Caroline Chisholm Centre for Health Ethics. His dissenting comment appended to Recommendation 3 is a masterpiece of clear thinking and demolishes the ramshackle apologia of the dominant committee members.

Read Rec 3, below, and note the 'however' from the Committee about how there is no avoiding the lack of progress / lack of living up to the hype (yes, they even used the word 'hype' describing the promise of cloning, earlier in the report) and therefore even less likelihood that further experimentation would be approved in Australia.

Recommendation 3: (by majority) The provisions in the current legislation regarding SCNT should not be amended.

However, in reaching this recommendation, the Review Committee notes the lack of progress in SCNT research in animals and humans. The Review Committee believes that this must impact on the Licensing Committee’s interpretation of its statutory obligation, when it is considering any future application for a licence to undertake research involving SCNT, to take into account ‘the likelihood of significant advance in knowledge or improvement in technologies for treatment as a result of the use of excess ART embryos or human eggs, or the creation or use of other embryos, proposed in the application, which could not reasonably be achieved by other means’ when it is considering any future application for a licence to undertake research involving SCNT.

One wonders why they lack the ethical rigour to admit that cloning has failed the test of 'compelling promise and necessity', but McGovern makes that point with great strength straight after the Committee's majority comment. Read and admire this from McGovern: 

The foregoing represents a majority view of the Review Committee. Reverend Kevin McGovern, however, notes:

The approach recommended by the Lockhart Review, which stated that ‘the greater the potential benefits of an activity, the greater the need for ethical objections to be of a high level and widely accepted in order to prevent that activity. Conversely, where benefits are not yet established, or where there is widespread and deeply held community objection, then total prohibition through the legal system may be justified.’ Reverend McGovern believes that in 2011 the latter standard has been reached for SCNT. In 2006, SCNT seemed the only way to seek the benefits of regenerative medicine. With the advent of induced pluripotent stem cells, this is no longer the case. It is hard to see what SCNT now contributes to the progress of regenerative medicine. What would be lost if Australia’s regulatory regime permitted the harvesting of embryonic stem cells from excess embryos along with research with adult stem cells and induced pluripotent stem cells, but did not permit SCNT? 

Some scientists have proposed some possible benefits of SCNT, but their arguments are not entirely convincing. Dr Megan Munsie argues that SCNT-ES cells might more closely resemble ES cells than iPS cells. However, the evidence from animal work is that SCNT generally produces damaged or abnormal embryos. This strongly suggests that even if SCNT-ES cells more closely resemble ES cells, these SCNT-ES cells will still be genetically abnormal and inferior to ES cells. Professor Bob Williamson advocates SCNT to generate stem cell lines as disease models to study late-onset conditions. It is not clear, however, why SCNT-derived lines would be more useful than iPSC- lines. Beyond that, there is only the possibility of what ‘might’ be learnt if research into SCNT continues. The proposed benefits of SCNT research therefore seem not entirely convincing, sometimes rather small, and largely theoretical. On the other hand, SCNT involves the most profound of ethical concerns. It is the creation of human life which will be used in research and then destroyed. When people understand this, many people within the community are troubled by SCNT.

For all this, however, this most serious of ethical concerns has been judged less significant than the mostly theoretical benefits which might come if research into SCNT is allowed to continue. With this outcome, Reverend McGovern wonders whether the ethical concerns about SCNT research are ultimately being given anything more than lip-service.

Perfectly stated. If the Minister had done what was required of him by statute and tabled the Report on the 27th May when it was put on his desk, I know Senator Guy Barnett for one would have brought this passage of penetrating argument by McGovern to the attention of fellow Senators. The case for cloning now is so diminished that it could never carry a conscience vote like it did in the hysterically hyped days of 2006.

That, I suspect, is why the dominant players in this Review Committee have opted for the small target strategy, not moving any controversial amendments (other than on IVD gametes - more planned for a later post) and therefore not provoking the Senate to pay any real attention to the existing legislation. Likewise, the Minister's failure to table the Review in May - despite questions from at least one outgoing Senator, as I recall - is part of a small-target strategy of his own.

Perhaps that means the vile project of creating human embryos solely with their exploitation and destruction in mind will linger as a stain on the statues until a change of Government. So be it. For now, cloning is in terminal decline since the advent of iPS, and its futile life-support will indeed be switched off by a more morally serious Government in due course...

Lung stem cell? Promising, but no reason to take up smoking again...

Very interesting article today in the New Engalnd Journal of Medicine identifying another native adult stem cell, this time resident in the lung:

Human lungs contain identifiable stem cells. In animal models, these cells participate in tissue homeostasis and regeneration. They have the undemonstrated potential to promote tissue restoration in patients with lung disease.

For those without a subscription to NEJM, see the write-up in Forbes.

Very promising as a potential pathway for regeneration of damaged lung tissue.

NHMRC CLONING REVIEW DUE TO REPORT TO PARLIAMENT 27th MAY 2011

Thanks to all who made a submission to the Cloning Review (see Blog entry for Feb 15th).

The large majority of submissions argued against cloning, in light of the new, ethical alternative.

Read all the submissions at: https://legislationreview.nhmrc.gov.au/public_submissions

You can listen to our National Director's comments HERE in an online interview.

The concluding remarks in the submission by Australians for Ethical Stem Cell Research:

I trust that we have made the case that the scientific landscape of stem cell science has changed so dramatically since November 2007 that the argument about the ‘unique necessity’ for cloning no longer applies; that if our Senators and MPs had known in 2006 what we know now, cloning would never have been permitted. Arguments for SCNT/cloning are now marginal: its proposed role in mitochondrial disease is demonstrated here as a conceptual error, and the call to create cloned ESCs as a ‘comparison’ to iPSCs, even though we know ESCs are functionally identical to iPSCs, is truly clutching at straws. A sense of proportion – measuring the substantial ethical barrier to the creation of human embryos as mere research material, versus the shrivelled residual arguments for SCNT/cloning – should result in recommendations to repeal this inhuman and unjustified practice. 

Our submission online at the Cloning Review

The Cloning Review Committee is posting yesterday's last-day-rush of submissions, including ours, to the legislative review site. There are many well worth a read, over a good red one night this week...

Ours is at the link: https://legislationreview.nhmrc.gov.au/submission/submission-165 and opens with a line of argument tediously familiar to anyone who has followed this blog since 2009, and its predecessor, the pre-Yamanaka, "Conscience versus Con Science" since 2006:

Summary statement

SCNT/cloning is a human corruption and a scientific failure. It is unethical, in that it involves the creation of living human embryos solely for research and destruction. It is unnecessary, in that the stem cell revolution of 2007 has removed the sole scientific argument for cloning: SCNT/cloning is no longer the “unique method” for obtaining patient-matched pluripotent stem cells, in fact it has never obtained even a single human stem cell for all the millions spent and all the embryos created and destroyed. The new “induced pluripotent stem cell” (iPSC) technique has succeeded magnificently in achieving patient-matched pluripotent stem cells where cloning has failed. Further, the iPSC method is ethically uncontentious: it does not use women’s eggs and does not create and destroy human embryos. This Review Committee should recommend repeal of the unethical practice of SCNT/cloning - a practice which since 2007 has no plausible justification - and recommend restoring the long-standing prohibition on the creation of human embryos solely for research.

Action! March 15 Deadline to say NO to human cloning...

We only have until March 15th to tell the federal Cloning Review that we want this inhuman and unjustifiable science banned once again. Please see https://legislationreview.nhmrc.gov.au/2010-legislation-review for ‘how to make a submission’.


Background:In 2006, by just one vote in the Senate, a law was passed allowing human cloning – the creation of living human embryos solely for the purpose of research and destruction. The law bans the cloned embryo from being implanted in a woman’s womb, and decrees that the embryo must be destroyed before 14 days of age, but still permits the creation of embryonic human life solely for exploitation in stem cell experiments and IVF research.

That was wrong and unnecessary then, and even more unnecessary now – since the magnificent breakthrough by Yamanaka in November 2007 of ‘direct reprogramming’ of adult skin cells into the exact equivalent of embryonic stem cells, without ever creating or destroying a human embryo. This revolution in stem cell science means that scientists now have an entirely ethical method to obtain the specialized stem cells that cloning hoped to obtain but never has obtained. Cloning is a failed science; the new Yamanaka method has proven both simple and effective.

Reading:To get the latest on why cloning is both wrong and redundant, read my review article from Viewpoint magazine, “An Obituary for Human Cloning”. And browse this blog for some highlights of the new world of entirely ethical stem cell science - where there is no need for cloning.

Action:
Then please write a submission, however short and simple, to the committee. All we need to convey is that:

· It is wrong to create human embryos solely for research and destruction.
· We understand that cloning (SCNT) is one method of creating a living human embryo, as was confirmed at the Senate hearings in 2006 – the same method used for creating Dolly the sheep.
· We know that, since the Yamanaka 'iPS cell' breakthrough in November 2007 (see my review article) we have an entirely ethical, and proven, method of obtaining the specialised stem cells that cloning hoped (but failed) to obtain, so there is no longer any serious justification for cloning.
· If our Senators had known in 2006 what we know since the Yamanaka breakthrough, cloning would never have been considered, and no laws would have been passed.
· We now want the Review Committee to acknowledge the dramatically changed scientific landscape, and recommend to Parliament that the provisions allowing cloning are no longer scientifically justified, and should be repealed.

As always, the committee is dominated by well-known supporters of cloning (see my December entry on 'Cloning review at last'). That is a disgraceful derailment of a supposedly 'independent' review. However, that is not our primary concern. We need to send lots of careful, thoughtful submissions - even a short summary statement is fine, and there is no need to provide responses in all sections of the review - so they know that the public is aware that the old arguments for cloning no longer apply, that it is now a redundant science supported by unjustifiable laws.

FURTHER COMMENTS by our WA Rep: In 2002 the Commonwealth passed laws permitting research on so called “left over” human embryos but banning the deliberate creation of human embryos for research by any means, including a comprehensive ban on the cloning of human embryos.

A 2005 review of that legislation proposed revoking the ban on cloning and allowing human embryos to be created for research by cloning or by the use of eggs derived from aborted baby girls. Legislation implementing the changes passed the Senate by just one vote. It was given Royal Assent on 12th December 2006.

All states except Western Australia subsequently passed mirror legislation allowing cloning. In WA note was taken of the revolutionary developments in science in November 2007 which allowed pluripotent stem cells to be derived from any body cell by a process which avoided any creation or destruction of a human embryo.

Only Sydney IVF has been issued with licenses to experiment on cloning. Since obtaining the licenses on 16 September 2008 Sydney IVF has used 389 “clinically unsuitable” human eggs (ova) in an attempt to create cloned human embryos. In only 32 attempts was there development to the two cell stage and in no case was the eight cell stage passed. This is well short of the point at which embryonic stem cells could be extracted. The official report on the experiments states: No reproducible method for SCNT [somatic cell nuclear transfer] using clinically unsuitable eggs for the efficient epigenetic reprogramming of human embryonic stem cells to the blastocyst stage has been established to date.

It seems futile to be trying to clone using eggs that are no good at being fertilised. This approach was tried and abandoned by British researchers at Newcastle some years ago. They switched to using fresh, good quality eggs obtained through an egg sharing arrangement with women undergoing IVF at half price rates – a form of payment for eggs.

This approach is currently banned in Australia.

In July 2009 review committee member Loane Skene called for Australia to follow the lead of New York State which broke ranks in the US by allowing payments to women for eggs for research. It seems likely Skene will seek to persuade the committee to recommend this change.
Inducing ovulation in women in order to harvest their eggs exposes them to a massive 239% increased risk of uterine cancer, 150% increased risk of non-Hodgkin’s lymphoma and a 42% increased risk of breast cancer.

Up to 10 percent of patients undergoing induced ovulation experience severe ovarian hyperstimulation syndrome (OHSS) with symptoms including loss of future fertility, kidney or multiple organ failure, and death. Deaths from OHSS include 32 year old Irish woman Jacqueline Rushton, who died in Dublin on 14 January 2003. She suffered a gradual deterioration of her organs, virtually all of which were slowly destroyed. Temilola Akinbolagbe, a young woman who died in April 2005 in London, suffered a more sudden death from a massive heart attack linked directly to OHSS.

You are encouraged to make a brief submission to the legislative review:
- opposing any proposal to allow payment for human eggs for cloning research;
- calling on cloning to be banned because it is a failed approach to obtaining stem cells for therapy and it involves the unethical creation and destruction of human embryos.

Submissions can be made online at: https://legislationreview.nhmrc.gov.au/node/add/submission

Hard copy submissions may be mailed to: Legislation Review, National Health and Medical Research Council, GPO Box 1421 Canberra ACT 2601

Nice in Mice: skin straight to heart cells (forget embryos)

I can’t improve on my comrade David Prentice’s coverage of this latest bit of Direct Reprogramming Wizardry. I wonder if this new way of obtaining perfectly-matched stem cells (with no need for embryos or cloning, and apparently minimising the risks inherent even in iPS cells) will generate the sort of science-media interest that the futile tinkering at Geron generated...

Changing Skin Directly to Beating Heart Cells
by David PrenticeJanuary 30, 2011 http://www.frcblog.com/2011/01/changing-skin-directly-to-beating-heart-cells/

Scientists with the Scripps Research Institute have directly converted adult mouse skin cells into beating heart cells, without using any stem cell intermediate, and without the laborious process of generating embryonic-like stem cells. Using a reprogramming process similar to that for induced pluripotent stem (iPS) cells, they were able to directly produce “spontaneously contracting patches” of heart cells in the lab. The research is published online in Nature Cell Biology.

The group used the same four genes (“Yamanaka factors”) often used to make iPS cells, but switched off the gene activity after a few days, before the cells had a chance to become iPS cells. Then they stimulated the cells with factors to direct them into becoming cardiac-type cells.

According to Dr. Sheng Ding, senior author of the study:
“In 11 days, we went from skin cells to beating heart cells in a dish. It was phenomenal to see.“This work represents a new paradigm in stem cell reprogramming. We hope it helps overcome major safety and other technical hurdles currently associated with some types of stem cell therapies.”

The worrisome type of stem cells is pluripotent stem cells, i.e., embryonic stem cells, which have a propensity to grow out of control and form tumors.

Back in 2009, similar story titles (converting skin to beating heart cells) appeared when a group used skin cells to make human iPS cells (pluripotent, embryonic-like stem cells), then turned those iPS cells into cardiomyoctyes in culture. But because of the embryonic-like nature of iPS cells, their practical application for patient transplant is in doubt. When pluripotent cells are injected in mice, they cause cancer-like growths.

Direct reprogramming, going from one cell type to another without forming a pluripotent stem cell, offers a way around the practical problems of pluripotent stem cells. Several other groups have shown the possibility of direct reprogramming to form various tissue types.

Meanwhile, adult stem cells have already successfully treated patients with chronic heart failure.