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.
NOTE
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.
