Wednesday, February 4, 2015

Cloned embryos and designer babies: the appalling vista of Britian’s brave new world.

The House of Commons voted on Feb 3rd to approve draft legislation that will make the United Kingdom (UK) the first country in the world to permit "three parent" babies.
Babies resulting from this process will be genetically modified having DNA from a mother, a father and from a female donor. The draft legislation known as, The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, was passed by a vote of 382 to 128 against. The measure will now go to the House of Lords for their consideration later this month.

The treatment combines the genetic material from the eggs of two women with the sperm of a man to produce an IVF embryo that has DNA from three individuals. The Regulations would permit two techniques: Maternal Spindle Transfer, which modifies the mother's egg pre-fertilization and Pro Nuclear Transfer, which modifies an existing embryo in attempts to prevent the transfer of mitochondrial disease from mother to child.

MPs approved the Regulations despite serious safety, ethical and legal concerns with the untested practice. Not only will mitochondrial donation open the door to the eugenics of "designer children" with the favoring of certain traits over others, it shows no dignity for the preborn child, who is created and destroyed at will. The practice itself is untested. Fiona Bruce MP asked, "Where will it lead? The answer has to be that we stop here. The answer has to be that we say this is a red line in our country, as in every other country in the world, that we will not cross."
Prior to the vote SPUC General Secretary Paul Tully called on MP's to reject
the so-called "three-parent" embryo regulations designed to allow the cloning of embryos. The regulations would permit human germ-line manipulation for the first time.

The Society according to Tully is appealing to MPs to oppose the regulations being debated in the House of Commons today which would allow cloned human embryos to be created and implanted in a woman.

Dr Peter Saunders in his BLOG Christian Medical Comment sets out the problems associated with this practice in a very clear manner, and raises what he terms as 5 big questions for consideration. 

We would not however go along with the suggestion of IVF with egg donation both of which bring their own sets of ethical issues.

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. (see note above)

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.

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.