New three-parent embryo research leaves many questions unanswered

A new IVF-based technique ‘is likely to lead to normal pregnancies and reduce the risk that babies born will have mitochondrial disease’, according to researchers at the Wellcome Trust Centre for Mitochondrial Disease at Newcastle University.

Published today (Wednesday 8 June 2016) in the journal Nature, scientists report the first in-depth analysis of human embryos created using a new ‘three-parent’ technique devised to reduce the risk of mothers passing on mitochondrial disease to their children.

Mitochondrial diseases are inherited maternally and cause a variety of severe conditions that currently have no cure. The UK government has recently legalised the controversial use of embryos carrying DNA from three genetic parents to prevent their transmission, but the proposed techniques have been criticised on both ethical and safety grounds (see my previous review).

One of these techniques, called ‘early pronuclear transfer’ (see picture), involves transplanting the nucleus from a fertilised egg into a donated egg, which contains healthy mitochondria, shortly after fertilisation.

Today researchers, in a study involving over 500 eggs from 64 donor women, published results which they say show that the new procedure does not adversely affect human development and will greatly reduce the level of faulty mitochondria in the embryo. They further claim their results suggest that the technique will lead to normal pregnancies whilst also reducing the risk of babies having mitochondrial disease.

The results of the new study will be considered by the Human Fertilisation and Embryology Authority‘s (HFEA) Expert Scientific Panel. The HFEA will ultimately decide whether to issue the first licence to a clinic. A licensed clinic would allow couples affected by mitochondrial disease to have the choice of whether to use pronuclear transfer to try and have healthy children.

What should we make of it all?

This new research might have calmed the nerves of already committed enthusiasts for this controversial technique but it leaves many questions still unanswered.

The Newcastle researchers admit in their press release that one of five stem cell lines derived from embryos they created showed an increase, rather than a decrease, in the percentage of mitochondrial DNA carryover (this important fact is left out in Fergus Walsh's misleading BBC report). 

Rather than bringing reassurance this actually confirms concerns highlighted just one month ago by another researcher in the same journal Nature that three-person embryos ‘may fail to vanquish mutant mitochondria’.

Scientists in New York showed that ‘even if a small number of mutant mitochondria are retained after the transfer’ – an admittedly common occurrence — they can ‘outcompete healthy mitochondria in a child’s cells and potentially cause the disease the therapy was designed to avoid’.

Early embryos that ‘look’ normal (they were only grown to six days) do not necessarily translate into older embryos, fetuses, babies and children that are normal. The deep concerns that this technique will not work, or will work partially producing a whole host of new problems, have not yet been addressed.

It is noteworthy that this other US research has not been given attention by the Newcastle team and the BBC. Not as convenient perhaps?

Serious ethical and safety concerns remain, including the risky and invasive harvesting of large numbers of human eggs from donor women and the identity confusion of genealogically confused progeny, if we ever get that far.  

Adoption of children, babies or embryos still remains a viable and safe alternative for these families and DNA editing, which has already been successfully used to prevent transmission of mitochondrial disease in mice, is a far more precise, specific, clever, natural and ethical solution to this problem than stripping nuclei out of embryos and transplanting them into donor eggs.

The end does not justify the means and the greatest scientific advances are always ethical. The human embryo must always be treated with the utmost respect. 

It is noteworthy that Shimya Yamanaka, the 2012 Nobel prize winner,  through patient and meticulous research, discovered an ethical alternative to embryo research that revolutionised scientific thinking and won him a Nobel prize.

By contrast, this new research is unnecessary, unethical and still unproven to work in non-human primates, let alone human beings. We should put a halt to it and instead pursue scientific solutions that are more safe, natural, ethical and scientifically precise – more Michelangelo than Picasso.

This is a boundary that should not have been crossed. There are other options (see my blogpost on ‘thirteen solutions to mitochondrial disease assessed’) which offer better solutions. 

Three-parent embryos for mitochondrial disease – the five big questions MPs failed to answer

Today MPs in the House of Commons voted 382-128 to make Britain the first country in the world to offer controversial ‘three-parent’ fertility treatments to families who want to avoid passing on mitochondrial diseases to their children. 

Last week forty scientists from 14 countries urged the British legislature to approve the new laws allowing mitochondrial DNA transfer.

The stance of scientists created huge pressure for MPs who risked being labelled ‘ignorant’ or uncaring for objecting. But the question is not nearly as simple as it looks on first appearance. These new regulations are dangerous. No other country has officially legalised the techniques and no one can predict what the consequences for future children will be.

The Department of Health claimed widespread public support for the measure – despite its own consultation showing a majority (62%) actually oppose the plans. In addition a ComRes poll conducted in August 2014 found that only 18% of people support a change in the law to permit the creation of three-parent children through genetic modification.

There are about 50 known mitochondrial diseases (MCDs), which are passed on in genes coded by mitochondrial (as opposed to nuclear) DNA. They range hugely in severity, but for most there is presently no cure and little other than supportive treatment (see CMF briefing paper here and previous articles on the issue here).

It is therefore understandable that scientists and affected families want research into these two related ‘three-parent embryo’ techniques (pronuclear transfer (PNT) and maternal spindle transfer (MST)), to go ahead. But there are good reasons for caution.

Here are the five big questions MPs failed to answer today.

Is it necessary?

This is not about finding a cure. It is about preventing people with MCD being born. We need first to be clear that these new technologies, even if they are eventually shown to work, will do nothing for the thousands of people already suffering from mitochondrial disease or for those who will be born with it in the future. Parents will generally not even know that they run a risk of producing an affected baby until after the birth of the first. And it is very difficult to predict the severity of the disease in a given case. There is huge variation even within affected families.

Mitochondrial disorders are also relatively rare. Perhaps 1 in 200 children are born each year with abnormal mtDNA but only 1 in 10,000 are severely affected. It was suggested in 2001 that the proposed techniques, if they work, could 'save' around ten lives each year. 

Last week however a JME article upped these numbers to 150.  I'm not in a position to seriously dispute these figures as I don't have access to the patient data on which they are based.  

Nevertheless, to jump from 10 to 150 (via 20 and 80) is quite a jump and raises serious questions about creative accounting.  How were their original estimates so off the mark, if the new estimates are supposedly more reliable?  Moreover, there is a fair bit of extrapolation involved and the validity of this depends on the distribution of people with mutant mitochondrial DNA being evenly spread throughout the UK and also the USA.

Either way we are not talking about huge numbers here. There are also already some alternative solutions available for affected couples including adoption and IVF with egg donation.

Is it safe?

This is far from established. Each technique involves experimental reproductive cloning techniques (cell nuclear transfer) and germline genetic engineering, both highly controversial and potentially very dangerous. Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, California has argued  in an piece titled ‘A slippery slope to germline modification’ that were the United Kingdom to grant a regulatory go-ahead, it would unilaterally cross ‘a legal and ethical line’ observed by the entire international community that ‘genetic-engineering tools’ should not be used ‘to modify gametes or early embryos and so manipulate the characteristics of future children’.

Cloning by nuclear transfer has so far proved ineffective in humans and unsafe in other mammals with a large number of cloned individuals spontaneously aborting and many others suffering from physical abnormalities or limited lifespans. Also, any changes, or unpredicted genetic problems (mutations) will be passed to future generations. In general, the more manipulation needed, the higher the severity and frequency of problems in resulting embryos and fetuses.

Prof Stuart Newman's recent article in Huffington Post is a brilliant analysis of the way scientists have pulled the wool in misrepresenting the scientific facts to a gullible public and parliament (See also  Marcy Darnovsky's excellent open letter to MPs on safety issues).

Will it work?

There are reasons to be deeply sceptical about the grandiose claims being made by scientists and patient interest groups with vested interests. This technology uses similar ‘nuclear transfer’ techniques to those used in ‘therapeutic cloning’ for embryonic stem cells (which has thus far failed to deliver) and animal-human cytoplasmic hybrids (‘cybrids’). The wild claims made about the therapeutic properties of ‘cybrids’ by the biotechnology industry, research scientists, patient interest groups and science journalists duped parliament into legalising and licensing animal human hybrid research in 2008.

Few now will remember Prime Minister Gordon Brown’s empty promises in the Guardian on 18 May that year of ‘cybrids’ offering 'a profound opportunity to save and transform millions of lives' and his commitment to this research as 'an inherently moral endeavour that can save and improve the lives of thousands and over time millions of people'. That measure was supported in a heavily whipped vote as part of the Human Fertilisation and Embryology Bill, now the HFE Act. But ‘cybrids’ are now a farcical footnote in history. They have not worked and investors have voted with their feet. Ironically, it was in that same Act of Parliament, that provision for this new research was also made.

In In early 2009 it was said that there was no funding for cybrids in the UK and ironically only three research licences were granted: to Dr S Minger of King’s College London (R0180), to Prof Lyle Armstrong of University of Newcastle Upon Tyne (R179) and to Dr Justin St. John of the University of Warwick (R183).

What happened? Basically zilch! Dr St John emigrated to Australia (where such work is prohibited), Lyle Armstrong eventually switched to working with iPS cells (a more fruitful ethical alternative) and Stephen Minger left academia to work for GE Healthcare (where he promotes work with hES cells for drug screening but definitely does not work with interspecies combinations). 

This is hugely relevant for the three-parent embryo debate as 223 charities, egged on by the false promises of the scientific community, wrote to the Prime Minister in 2008 to get him to reverse his decision on hybrids and not stand in the way of disease treatments. Déjà vu?

Is it ethical?

No, there are actually huge ethical issues. A large number of human eggs will be needed for the research, involving ‘harvesting’ that is both risky and invasive for women donors. How many debt-laden students or desperate infertile women will be exploited and incentivised by being offered money or free IVF treatment in return for their eggs?

Egg donation is neither straightforward nor harmless. It involves using drugs to shut down the woman’s own ovaries, then stimulating them to produce multiple follicles then surgically extracting the resulting eggs. This all has significant health and ethical implications for the donor, including health risk to the donor from powerful hormonal treatments, injections, invasive surgery, and yet it is not for her own benefit.

A study at the Newcastle Fertility Centre, reported in Human Fertility, found that more than 20 eggs were collected from at least one in seven patients, that 14.5% of these women were subsequently admitted to hospital and nearly all reported symptoms consistent with ovarian hyperstimulation syndrome (OHSS). We do know from a recent report that just under half of 864 reported clinical incidents between 2010-2012 were due to OHSS. And: ‘Each year approximately 60 instances of severe OHSS and 150 cases of moderate OHSS are reported to the HFEA.’

How many thousands of human embryos will be destroyed? If it ever works, what issues of identity confusion will arise in children with effectively three biological parents? What does preventing those with mitochondrial disease being born say about how we value people already living with the condition? Where will this selection end? Some mitochondrial diseases are much less serious than others. Once we have judged some affected babies not worthy of being conceived, where do we draw the line, and who should draw it?

Is the debate being handled responsibly?

No. The research scientists involved have huge financial, ideological and research-based vested interests and getting the regulatory changes and research grants to continue and extend their work is dependent on them being able to sell their case to funders, the public and decision-makers. Hence their desire for attention-grabbing media headlines and heart rending (but highly extreme and unusual) human interest stories that are often selective about what facts they present.

It must be tempting for politicians to make promises of ‘miracle cures’ in years to come which no one may remember. But I suspect it is much more about media hype than real hope.

This new push is being driven as much by prestige for government, research grants for scientists and profits for biotechnology company shareholders as anything else.

Cool heads required

MPs know there is widespread public opposition to growing genetically modified (GM) crops in the UK. How much more cautious should they be about allowing GM babies to be created?

These techniques are highly experimental, unproven, known to be very unsafe (bear in mind that children’s lives will be the experiment), ineffective, costly, a waste of public money, insufficiently understood, unnecessary (only potentially helping between 10 and 150 families a year) and will require large numbers of eggs to proceed, even for just a few families.

Genuine concerns about this new mitochondrial technology have been swept aside in Britain in the headlong rush to push the scientific boundaries.

Furthermore in many countries around and the world, and by commentators from both secular and faith based scientific backgrounds, Britain is viewed as a rogue state in this area of research.

This move is both premature and ill-conceived.

Fiona Bruce MP  laid a motion opposing the approval of the regulations which cuts to the chase and encapsulates the concerns beautifully. But sadly it was rejected.

“That this House declines to approve the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 because many of the safety tests recommended by the Human Fertilisation and Embryology Authority Expert Panel have yet to be performed and peer-reviewed and their results made public; because no other country in the world has legalised the proposed techniques for ethical reasons; because major international bodies including the United States Food and Drug Administration have expressed the view that not enough preclinical work has been done to ensure that the proposals are safe; because they permit the genetic modification of human embryos and oocytes; because these regulations permit human embryos to be created only to be destroyed; because there are unanswered questions regarding the legality of the regulations at both domestic and international level; and because this House should not be asked to approve regulations of such ethical significance without a fully informed debate and before the results of the above safety tests are available for consideration.”

MPs should have kept cool heads and instead concentrated on finding real treatments and providing better support for affected individuals and their families rather than spending limited health resources on unethical, risky and highly uncertain high tech solutions that will most likely never deliver.

I hope the Lords will subject this issue to more careful scrutiny when they consider it in a few weeks' time.

Three out of every ten human deaths in the UK occur as a result of ‘medical intervention’ before birth

In 2012 there were 499,331 deaths registered in England and Wales, 54,937 in Scotland and 14,756 in Northern Ireland – a total of 569,024 human deaths.

In the same year there were 185,122 abortions carried out on women resident in England and Wales, 1,330 on women from other parts of the UK (including 905 from Northern Ireland) and 12,447 in Scotland – a total of 198,899 human deaths.

According to the answer given to a parliamentary question asked by Lord Alton yesterday, there were 166,631 human embryos that were allowed to perish in the UK in 2012 – a total of 166,631 human deaths. These are 'excess' embryos created in a laboratory by IVF technology that are thrown away.

In addition there are about 250,000 miscarriages in the UK every year – a total of 250,000 human deaths.

So that’s a total of 1,184,554 human deaths in the UK in 2012 – 569,024 registered deaths, 250,000 miscarriages, 198,899 aborted babies, and 166,631 embryos allowed to perish.

Of this total number of human deaths over half (52%) were human beings who were never born, and of these 365,530 (31%) were human lives ended by doctors before birth (abortions and embryos allowed to perish).  

Each of this latter group were human beings that no one wanted and that a doctor, or other health professional, acted to destroy.

Abortion and embryo disposal are against the Hippocratic Oath, against the Declaration of Geneva, against the International Code of Medical Ethics and against the Judeo-Christian ethic on which the laws of our country were originally based.

In 1947 the British Medical Association called abortion 'the greatest crime'.

But it is now so commonplace in Britain that we don’t even bother to mention it as a cause of human death despite the fact that every abortion stops a human heart beating.

The fact that the deaths of human beings are excluded from official death statistics is a symptom of how far we have fallen.

There is no one in the UK more innocent, more vulnerable and killed in greater numbers than the pre-born baby.

And there is no more dangerous place for a human being than the womb... or a petri dish. 

British government hesitates on three parent embryos as international opposition mounts

The legalisation of three parent embryos for mitochondrial disease in Britain has been facing massive opposition all over the world with so far little response from Westminster.

But an answer to a parliamentary question this week gives the first sign that the government may be pausing to draw breath before implementing the new technique.

Apparently they are not going to proceed with three parent children regulations for now but rather have opted for yet another consultation.  

In response to a Parliamentary question asked this week by Lord Alton Government minster Earl Howe said that the Government will publish draft regulations as part of a public consultation shortly:

‘The Government is currently developing draft regulations, which will describe in more detail the proposed approach for regulating mitochondria donation treatment. The Government is planning to publish these, as part of a public consultation, shortly.’

I recently highlighted an article in Nature arguing that the UK’s decision to trial the technique is ‘both premature and ill-conceived’.

Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, California had argued  in an piece titled ‘A slippery slope to germline modification’ that were the United Kingdom to grant a regulatory go-ahead, it would unilaterally cross ‘a legal and ethical line’ observed by the entire international community that ‘genetic-engineering tools’ should not be used ‘to modify gametes or early embryos and so manipulate the characteristics of future children’.

Christian Medical Fellowship has recently published a paper on ‘three parent embryos for mitochondrial disease’ which was strongly critical of this new technology on both theological and scientific grounds. 

This followed submissions that CMF made on the issue to both the Human Fertilisation and Embryology Authority (HFEA) and the Nuffield Council. We have more recently made similar points to the US Food and Drug Administration (FDA).

I have also argued on this blog that the technique involved is unsafe, unethical and unnecessary (see here, here, here and here).

Genuine concerns about this new mitochondrial technology have been swept aside in Britain in the headlong rush to push the scientific boundaries.

But in many countries around and the world, and by commentators from both secular and faith based scientific backgrounds, Britain is viewed as rogue state in this area of research.

Let’s hope that this hesitation means that the government is at last beginning to listen. 

European Campaign to protect human embryo gains one million signatures

Last week, 'One of Us' announced that 1 million EU citizens had signed its initiative to protect tiny human lives. 

There will now be an official public hearing on the need to ban EU funding for activities that involve destroying human embryos. 

It's an amazing achievement - and this week, European Commission Vice President Maroš Šefčovič officially congratulated the campaign.

The ‘One of Us’ campaign underlines the moment of conception as the beginning of human life, and aims to prevent any funding of activities which result in the destruction of human embryos, particularly focusing on areas of research, development aid and public health (see previous CMF update by Philippa Taylor  for more detail). 

It was launched in January 2013 by leaders in twenty European countries and follows a European Court of Justice ruling in 2011, in a lawsuit brought by Greenpeace, that human life begins at conception and deserves legal protection (See my previous blogs on the ‘Bruestle Judgement’  here and here).

‘One of Us’ is a European Citizen Initiative, a new method provided in the Treaty of Lisbon for proposing legislation in the European Union. Such an initiative must have the support of at least 7 of the 27 member states and each individual state involved must collect a minimum number of signatures based on its overall population. 

Now that it has gathered one million signatures, the European Parliament is duty-bound to schedule a debate on the issue. With just six weeks to go until the deadline, organisers are keen to boost the total still further - the higher the total, the greater the political and public impact.  

Currently, European policies are at odds with the European Court of Justice decision. Europe today is funding scientific research that destroys and manipulates embryos and funds international groups touting abortion. With the recognition of life from the moment of conception, Europe’s policies would shift in favour of unborn life.

The UK sadly remains woefully under-represented ... Across Europe the initiative has proved very successful - but here in the UK it is yet really to take off. 

How to sign

To take part in this campaign you must be resident in a EU State, be 18 or over and eligible to vote in the European Elections.

To sign the petition you need to go to the ‘One of Us’ website (click here) and follow the few simple instructions. It takes about two minutes from start to finish.

The ‘One of Us’ campaign reminds us that we were all embryos once. But some scientific research activities destroy human embryos. Please help us stop public funding for this research.

Further background

3.8 million human embryos created to produce 122,000 live births – success rate of 3.2%

The moral status of the human embryo – when is a person?

UK decision to trial three parent embryos for mitochondrial disease ‘both premature and ill-conceived’ (Nature Magazine)

Christian Medical Fellowship has recently published a paper on ‘three parent embryos for mitochondrial disease’ which was strongly critical of this new technology on both theological and scientific grounds. 

This followed submissions that we made on the issue to both the Human Fertilisation and Embryology Authority (HFEA) and the Nuffield Council.

I have also argued on this blog that the technique involved is unsafe, unethical and unnecessary (see here, here, here and here).

I was therefore most interested to see these same views expressed this week an article in Nature arguing that the UK’s decision to trial the technique is ‘both premature and ill-conceived’.

Marcy Darnovsky (pictured) is executive director of the Center for Genetics and Society in Berkeley, California. In an article titled ‘A slippery slope to germline modification’ she points out that ‘those opposed to green-lighting mitochondrial replacement have been described in some quarters as religious objectors, against all types of IVF’.

However, she says, ‘many secular and actively pro-choice scientists, bioethi­cists and women’s-health advocates have voiced grave and detailed concerns about the safety and utility of mitochondrial replacement, and about authorizing the intentional genetic modification of children and their descendants.’

Were the United Kingdom to grant a regulatory go-ahead later this year, she argues, it would unilaterally cross ‘a legal and ethical line’ observed by the entire international community that ‘genetic-engineering tools’ should not be used ‘to modify gametes or early embryos and so manipulate the characteristics of future children’.

Darnovsky is very clear that ‘mitochondrial-replacement procedures would constitute ger­mline modification’.

She calls claims that such therapy would not affect a person’s identity ‘scientifically dubious’  and warns that ‘the permissive record of the UK regulatory authorities’ raises the prospect that inheritable mitochondrial changes would be used as a ‘door-opening wedge towards full-out germline manipulation, putting a high-tech eugenic social dynamic into play’.

To the claim that mitochondrial techniques would save lives, she points out that ‘these women have much safer alternatives, including pre-implantation genetic diagnosis and the use of third-party eggs with conventional IVF’.

She questions the HFEA’s claims that 1 in 200 children is born each year with a form of mitochondrial disease and the media’s uncritical acceptance of this figure, pointing out that the number is ‘more like 1 in 5,000’ (R. H. Haas et al. Pediatrics 120;1326–1333; 2007).

In addition she notes that among that much smaller group, a significant majority of cases involve mutations in nuclear as well as in mito­chondrial DNA, and so could not be helped by mitochondrial replacement.

Safety, she adds is ‘unproven’ and the results of animal trials are ‘far from reassuring’. Her overall assessment?

‘The question raised by these proposals is whether a risky technique, which would at best benefit a small number of women, justifies shred­ding a global agreement with profound significance for the human future. We need a moratorium on procedures based on human germline modification while that question is widely and fairly considered.’

Genuine concerns about this new mitochondrial technology have been swept aside in Britain in the headlong rush to push the scientific boundaries. But in many countries around and the world, and by commentators from both secular and faith based scientific backgrounds, Britain is viewed as rogue state in this area of research.

Over 850,000 people have signed the petition to protect human embryos in Europe. Have you?

The ‘One of Us’ campaign underlines the moment of conception as the beginning of human life, and aims to prevent any funding of activities which result in the destruction of human embryos, particularly focusing on areas of research, development aid and public health (see previous CMF update by Philippa Taylor  for more detail). 

It was launched in January 2013 by leaders in twenty European countries and follows a European Court of Justice ruling in 2011, in a lawsuit brought by Greenpeace, that human life begins at conception and deserves legal protection (See my previous blogs on the ruling here and here).

‘One of Us’ is a European Citizen Initiative, a new method provided in the Treaty of Lisbon for proposing legislation in the European Union.

Such an initiative must have the support of at least 7 of the 27 member states and each individual state involved must collect a minimum number of signatures based on its overall population. 

If the campaign gathers one million signatures, the European Parliament is duty-bound to schedule a debate on the issue.

So far 180,000 signatures have been gathered, leaving only 150,000 more required by November 2013.

Currently, European policies are at odds with the European Court of Justice decision.

Europe today is funding scientific research that destroys and manipulates embryos and funds international groups touting abortion.

With the recognition of life from the moment of conception, Europe’s policies would shift in favour of unborn life.

How to sign

To take part in this campaign you must be resident in a EU State, be 18 or over and eligible to vote in the European Elections.

To sign the petition you need to go to the ‘One of Us’ website (click here) and follow the few simple instructions.

It takes about two minutes from start to finish.

The ‘One of Us’ campaign reminds us that we were all embryos once. 

But some scientific research activities destroy human embryos.

Further background

3.8 million human embryos created to produce 122,000 live births – success rate of 3.2%

The moral status of the human embryo – when is a person?

3.8 million human embryos created to produce 122,000 live births – success rate of 3.2%

The Daily Telegraph this weekend reports on a new expert study which has raised fears that some clinics may be offering techniques that put the embryo at risk for their own profit.

The review, carried out by Dr Justin McCracken, the former head of the Health Protection Agency, highlighted a new technique, known as Pre-Implantation Genetic Screening (PGS), as one which is possibly being offered inappropriately for commercial reasons.

For a fee, which can run into thousands of pounds, clinics can check embryos created by a successful IVF cycle for certain genetic abnormalities and only implant those that appear normal.

The process is becoming especially popular for older couples seeking IVF, because embryos created from their sperm and eggs have a higher chance of abnormalities. As it involves the removal of a cell from an embryo (see picture) it carries some risk for the embryo being tested.

Dr McCracken said the jury was still out on whether PGS improves the chances of having a baby and warned there is a risk of harm to the foetus. He said it was vital that the regulator checks that clinics are not simply recommending it to boost profits.

 ‘I understand that there is no clinical consensus regarding its efficacy, but there is a real risk to the embryo in carrying it out.’ (emphasis mine)

This is a somewhat curious statement. Dr McCracken seems (appropriately) concerned about the risk of damage to a few hundred embryos each year undergoing PGS.

But he is curiously silent (or perhaps unaware) that over three million embryos have perished or been deliberately destroyed since 1990 as a result of procedures made legal by the Human Fertilisation and Embryology Act.

Liberal Democrat Peer Lord Alton recently asked in parliament how many embryos have been created in each year since the commencement of the Human Fertilisation and Embryology Act 1990, and how many of these have resulted in live births.

Figures given in reply by the Under-Secretary of State at the Department of Health Earl Howe showed that 3,806,699 embryos have been created since 1990. Between 1992 and 2006 a total of 122,043 live births occurred according to figures from the HFEA given alongside his reply (see also here).

122,043 live births from 3,806,699 embryos represent a success rate of 3.21% (1 in 30). Or, to put it another way, 3,684,656 embryos never made it to birth. CMF has highlighted this ratio of 1 in 30 before.

These figures make McCracken’s concern about PGS embryos alone look like what Jesus called ‘straining a gnat whilst swallowing a camel’ (Matthew 23:23-24).

In a letter to the Telegraph, as yet unpublished, disability rights advocate Ann Farmer has highlighted the fact that, in addition to the vast wastage of embryos, some women have also died from complications of infertility treatments such as OHSS. She comments:

‘The whole point of the infertility industry is to manufacture babies out of embryos… A car factory that managed to accumulate 3,684,656 surplus models between 1990 and 2012 and in addition killed some of its customers would surely have gone out of business long ago.’

In 1948 the World Medical Association adopted the Declaration of Geneva which included the affirmation, ‘I will maintain the utmost respect for human life from the time of conception, even against threat’.

Today’s doctors, it seems, take a contrary view.

If you agree with today’s doctors that early human life can be treated as a disposable commodity then the figures that Lord Alton has uncovered (not much short of the current population of New Zealand!) will probably not bother you much at all.

But if, like me, you believe that they are special creations made in God’s image, which should be granted respect, wonder, empathy and protection you will no doubt be very concerned indeed.

See also ‘The moral status of the embryo. When is a person?’

The moral status of the human embryo – when is a person?

The moral status of the embryo is one of the key pressure-points in ethical debates about post-coital contraception, therapeutic cloning, pre-implantation diagnosis, artificial reproduction, embryo research and cloning.

The issue, which has profound implications for medical practice as doctors, has divided people for centuries and remains controversial.  

It is a fundamental principle both of Christian teaching and also of natural justice that human beings deserve utmost respect.

Christians believe that human beings have been individually created by God and derive their integrity and worth from the fact that they are made in the image of God - regardless of genotype, age, size, location or degree of dependence and disability.

The presence of a disability, either inherited or acquired, does not detract from a person 's intrinsic worth. All human beings are thereby worthy of the utmost respect. They must never be treated as means to an end. At the heart of the Christian ethic is self-giving love, whereby the strong make sacrifices for, and if necessary lay down their lives for, the weak.

Historical medical ethical codes, recognising the power and strength of doctors, have enshrined a view similar to the Christian one.

The Declaration of Geneva (1948) stipulates that doctors should ‘maintain the utmost respect for human life from the time of conception’.

In like manner, the International Code of Medical Ethics (1949)says that a doctor 'must always bear in mind the obligation of preserving human life from the time of conception until death'.

The Declaration of Helsinki (1975) says that in biomedical research:

 'the interest of science and society should never take precedence over considerations related to the well-being of the subject '.'In any research upon human beings,each potential subject should be adequately informed of the aims,methods, anticipated benefits and potential hazards for the study...'and 'the subjects should be volunteers '. 'It is the duty of the doctor to remain the protector of the life and health of that person on whom biomedical research is being carried out.'

By contrast the emerging view amongst contemporary ethicists (such as Peter Singer) is that human beings are nothing but the product of matter, chance and time; merely highly specialised animals.

The value of individual human beings is determined by their level of rationality or self-consciousness, physical attributes or capacity for relationship. Human life that has fewer of these qualities is of less value and can be disposed of. This 'Darwinian ethic 'with its aim of 'survival of the fittest 'places the demented, mentally handicapped, brain-injured and unborn (particularly the human embryo) in great danger.

The Human Fertilisation and Embryology Act (HFE Act) starts with a presupposition that has never been properly established - that the human embryo is not a human being with rights, and can therefore be treated as a means to an end.

In keeping with this foundation the Act sanctions embryo freezing, research and destruction along with abortifacient contraception and the disposal of abnormal embryos after genetic testing -practices that we would not countenance for human beings at any other stage of development.

Any biology textbook tells us that human development is a continuous process beginning with fertilisation; essentially the only differences between zygote and full term baby are nutrition and time.

Biologically the human embryo is undoubtedly human; it has human chromosomes derived from human gametes. It is also alive, exhibiting movement, respiration, sensitivity, growth, reproduction, excretion and nutrition.

It is therefore most accurate to speak of it as a human being with potential, a human being in an early stage of development or a potential adult; rather than a potential human being.

Philosophers, biologists, politicians and even theologians, however, have advanced arguments to undermine the status of the human embryo.

Here are three of the main ones with my responses:

1. Human embryos are not human beings worthy of respect because they lack rationality or capacity for relationship

This was the thinking behind the Warnock Committee’s recommendation of no embryo research beyond 14 days, as the neural crests first form 10 days after fertilisation. Others have suggested that breathing movements (12 weeks), or 'quickening' (20 weeks), or even the first breath of air should be the end point. It has even been argued that newborn babies are not persons since they lack 'self-awareness'.

But the development of the nervous system is a continuous process beginning at fertilisation and choosing an arbitrary point on this continuum discriminates between human lives on the basis of neural function. It is therefore 'neuralist '. Neuralism varies from racism and sexism only on the basis of the non-morally significant quality selected as the basis for discrimination. It is simply another form of ageism.

Our value as human beings does not consist in our capacities or attributes but in the fact that we are human. Arguing that the value of any human life depends on its place of residence (uterus, fallopian tube or petri dish) or degree of independence similarly discriminates on the basis of non-morally significant characteristics.

2. Human embryos are not human beings worthy of respect because they have a high mortality; about 40-70% don't reach maturity

But the value of human beings is not contingent on their survival rates. We don't say that refugees in Africa, flood victims in Asia or people with cancer are less important simply because they have a high mortality. 

Similarly, if survival rates at any stage of development are low this does not justify us actively ending life. The general strategy of medicine is rather to save and preserve life. The figure of 40-70%may well be an overestimate anyway. No one really knows how many early embryos die as there is no biochemical marker for fertilisation, as opposed to implantation.

3. Human embryos are not human beings worthy of respect because many embryos that do spontaneously abort have a high incidence of genetic (particularly chromosomal) abnormality

But all of these abnormal embryos have formed from the union of two human gametes. Aren't they therefore just human lives with severe disabilities, human lives with special needs? We would not argue in any other sphere that the value of any individual human life was contingent on how ‘normal’ it was; far less that abnormality justified killing by 'disposal '.

Conclusions

The arguments used for devaluing the status of the human embryo are both unconvincing and discriminatory. The human embryo should instead be given the benefit of any doubt regarding its status.

We have a choice: we either act to ensure the protection and survival of the most vulnerable members of our society by endorsing the Christian ethic of the strong making sacrifices for the weak; or we continue to ensure the ‘non-survival of the weakest’ by politicising the 'Darwinian ethic '.

The HFE Act has politicised Darwinism by enshrining in statute law discrimination against the weakest and most vulnerable members of the human race. It is built on a fundamental presupposition that has never been established logically, philosophically ethically or morally.  

Three parent embryos for mitochondrial disease – unsafe, unethical and unnecessary

Britain is planning to become the first country in the world to offer controversial ‘three-parent’ fertility treatments to families who want to avoid passing on mitochondrial diseases to their children.

The BBC reports this morning on the new techniques which it is claimed will children born through 'three-person IVF' who would carry genetic material from each of three different people.

There are about 50 known mitochondrial diseases (MCDs), which are passed on in genes coded by mitochondrial (as opposed to nuclear) DNA. They range hugely in severity, but for most there is presently no cure and little other than supportive treatment.

It is therefore understandable that scientists and affected families want research into these two related ‘three-parent embryo’ techniques (pronuclear transfer and maternal spindle transfer) to go ahead. But there are good reasons for caution.

This is not about finding a cure. It is about preventing people with MCD being born. We need first to be clear that these new technologies, even if they are eventually shown to work, will do nothing for the thousands of people already suffering from mitochondrial disease or for those who will be born with it in the future.

There are also already some alternative solutions available for affected couples including adoption and egg donation.

But apart from this I’m left with four big questions.

Is it safe? This is far from established. Each technique involves experimental reproductive cloning techniques and germline genetic engineering, both highly controversial and potentially very dangerous. Cloning by nuclear transfer has so far proved ineffective in humans and unsafe in other mammals with a large number of cloned individuals spontaneously aborting and many others suffering from physical abnormalities or limited lifespans. Also, any changes, or unpredicted genetic problems (mutations) will be passed to future generations. In general, the more manipulation needed, the higher the severity and frequency of problems in resulting embryos and fetuses.

Will it work? I am sceptical. This technology uses similar ‘nuclear transfer’ techniques to those used in ‘therapeutic cloning’ for embryonic stem cells (which has thus far failed to deliver) and animal-human cytoplasmic hybrids (‘cybrids’). The wild claims made about the therapeutic properties of ‘cybrids’ by the biotechnology industry, research scientists, patient interest groups and science journalists duped parliament into legalising and licensing animal human hybrid research in 2008. Few now will remember Gordon Brown’s empty promises in the Guardian on 18 May that year of ‘cybrids’ offering 'a profound opportunity to save and transform millions of lives' and his commitment to this research as 'an inherently moral endeavour that can save and improve the lives of thousands and over time millions of people'. That measure was supported in a heavily whipped vote as part of the Human Fertilisation and Embryology Bill, now the HFE Act. But ‘cybrids’ are now a farcical footnote in history. They have not worked and investors have voted with their feet. Ironically, it was in that same Act of Parliament, that provision for this new research was also made.

Is it ethical? No, there are huge ethical issues. A large number of human eggs will be needed for the research, involving ‘harvesting’ that is both risky and invasive for women donors. How many debt-laden students or desperate infertile women will be exploited and incentivised by being offered money or free IVF treatment in return for their eggs? How many thousands of human embryos will be destroyed? If it ever works, what issues of identity confusion will arise in children with effectively three biological parents? What does preventing those with mitochondrial disease being born say about how we value people already living with the condition? Where will this selection end? Some mitochondrial diseases are much less serious than others. Once we have judged some affected babies not worthy of being conceived, where do we draw the line, and who should draw it?

Is the debate being handled responsibly? No. The research scientists involved have huge financial and research-based vested interests and getting the regulatory changes and research grants to continue and extend their work is dependent on them being able to sell their case to funders, the public and decision-makers. Hence their desire for attention-grabbing media headlines and heart rending (but highly extreme and unusual) human interest stories that are often selective about what facts they present.

It must be tempting for politicians to make promises of ‘miracle cures’ in years to come which no one may remember. But I suspect it is much more about media hype than real hope.

This new push is being driven as much by prestige for government, research grants for scientists and profits for biotechnology company shareholders as anything else.

Let’s keep a cool head and instead concentrate on finding real treatments and providing better support for affected individuals and their families rather than spending limited health resources on unethical, risky and highly uncertain high tech solutions that will most likely never deliver. 

 (See BBC, Guardian, Times(£), Independent, Daily Mail and Telegraph).