A tiny piece in The Times today (News, p 15) suggests that the Human Fertilisation & Embryology Authority (HFEA), the fertility watchdog CORE has been watching very attentively since 1990 when it was first created, may be coming to the end of its life.

‘Expected to be abolished or scaled back’ is how the reporters describe the future of this controversial quango.The same article suggests that ethical guidance and decisions will transfer to Parliament or ministers in the Department of Health.

This is welcome news for many, but from  CORE’s perspective ethical guidance should never ever have strayed from Parliament in the first place.  From its earliest days the HFEA has taken upon itself innumerable controversial decisions which have been made through the democratic process.

News of the HFEA going under the axe is not unexpected.  At the last public meeting of the HFEA, which was as usual attended by but a mere handful of the public, Lisa Jardine, the current chair, intimated that there might be major changes ahead.

CORE looks forward to Parliament re-asserting its proper role in the governance of assisted reproduction.

Two reports, commissioned by the Government in relationship to abortion were published last week by the Royal College of Obstetricians and Gynaecologists (RCOG) on ‘Fetal Awareness’ and ‘Termination of Pregnancy for Fetal Abnormality’ (*).

CORE works with many colleagues nationally and internationally with practical expertise in the various fields of pre-natal and neo-natal science, and their first reactions have been extremely critical of the dogmatic position taken by the RCOG on the issue of fetal pain.

One commented on the absolute absurdity of drawing a 24-week line in the sand, before which it is claimed that the fetus has no conscious awareness or ability to feel pain.   Does pain kick in at midnight at 23 weeks and 7 days?  How does one accurately determine 24 weeks anyway was another pertinent question from the international experts.

‘Such an arbitrary time limit is absurd,’ said an Italian neonatal consultant, Prof Carlo Bellieni.  ‘The variables associated with human gestation are innumerable, and even the best estimates on age can be out by as many as 11 days.’  A British consultant remarked that two babies of relatively similar gestational age could have completely different physical capacities anyway.

Huge surprise was expressed that Professor Sunny Anand, world specialist on fetal pain, was not consulted in the preparation of these reports.  Professor Anand spoke in the UK Parliament last year on his research in this field and his expertise is widely acknowledged.

A much lower pain threshold, around 18-20 weeks, would  be the consensus of those CORE questioned on the issue, and most of those consulted agreed that we still have much to learn in this field.

‘I don’t think the RCOG statistics on survival rates in premature births stand up to broader scrutiny,’ said another Italian specialist.  ‘I know for certain that both the US and Italy are doing better than the UK in this area.  In Italian law rather than establish an arbitrary time limit our abortion law focuses on viability, which can vary quite considerably.’

An abortion took place in an Italian hospital last month at 22 weeks gestation.  The body of the little boy was left in a side room over the weekend and a priest discovered he was still alive 24 hours after the termination had taken place, even though he had received no medical support whatsoever.

A quick glance at the membership of both RCOG committees shows names of many well-known pro-abortion advocates, but few who are recognisably conservative on these issues. Surely some overtly pro-life doctors could have been included to give at least a token voice to the rights of the unborn child.

It is extraordinary that the name of London-based Prof Stuart Campbell, (not part of the pro-life movement) does not appear either among those on the committee or in the lists of those consulted.  As a pioneer and international expert in the field of ultrasonographic fetal diagnosis, his expertise should surely have been considered indispensable.

Why such inadequate and questionable reports, you ask?  We leave the answer to Prof Bellieni, who declared the moment he read them, ‘Abortion up to 24 weeks in normal circumstances, and up to birth for abnormality, and leave it to the doctor and the patient to decide if the abnormality justifies the termination?  How  incredibly convenient that these two reports totally and completely reinforce the status quo on abortion in the United Kingdom.’

The executive summary in the 2nd report on termination of pregnancy for disability claims not to ‘purport to give ethical guidance’.  This for CORE was the most chilling statement in both publications.

The termination of the life of a disabled unborn child is surely above all an ethical issue, not how or at what gestation it is performed.   Neither pain levels nor consciousness nor quality or length of life define what it is to be human.   Induced abortion for whatever reason and at whatever stage of gestation is always the destruction of a human life.

* www.rcog.org.uk/news/rcog-release-rcog-updates-its-guidance

The processes involved in sperm selection and subsequent fertilisation procedures (ICSI), as well as pre-implantation testing of the embryo (PGD) involving the removal of one or two early cells, are two aspects of modern IVF which are already under scrutiny.

A French study (*www.eshg.org/13.0.html), the largest to date confronting this problem, was presented in Gothenburg (Sweden) today, 14 June 2010, at the annual conference of the European Society of Human Genetics.  The study suggests that there is an increased risk of congenital malformation following IVF, but fortunately not as high as has been suggested by other smaller studies.

The risk factors are nevertheless significant, some occurring more frequently in boys (heart disease and malformations of the urogenital system) and others in girls, who have a five times higher rate of benign tumours near the skin.

UK legislation which governs the practice of assisted reproduction (HFE Act 2008), stresses the importance of the welfare of children in relationship to these new technologies, and we should all take very seriously this latest research.

CORE has always argued that IVF should be the last and not the first port of call when patients present with infertility problems, and every effort should be made where possible to restore fertility so that prospective parents do not automatically end up at the IVF clinic.

The biggest questions need to be raised in relationship to the use of IVF for purely social reasons – single women or post-menopausal conceptions for example.

Could it ever be ethical to expose future offspring to such risks, or any, in circumstances where true infertility is not even involved?    As a just society surely our duty should always be towards the best interests of the children.

Wilkinson argues that it is time to lift the prohibition in the United Kingdom on using assisted reproductive methods to identify and choose the sex of one’s child for social reasons.  In a radio interview he talked of some patients who find it very stressful not to have a child of the desired sex.

Sex selection is already permitted in the UK using pre-implantation genetic diagnosis (PGD), where parents undergoing assisted reproductive treatments identify and discard embryos who may be carrying a sex-related disease.  This is often elusively described as a process aimed at eradicating a particular disease, but of course what happens is that the unfortunate embryo carrying the disease is killed, or ‘allowed to die’ as the euphemism goes. This does not move us forward in any way in unravelling, let alone finding cures for the diseases in question.  It just kills the tiny human carrier.

PGD, thankfully, is not permitted in the UK simply because one has a preference for a boy or a girl. It is this restriction which Prof Wilkinson thinks should be lifted.  He argues that sex selection should be allowed within the parameters of our ‘carefully regulated reproductive medicine sector’.  This is the sector, CORE notes, which tolerates the raffling of human eggs, or the retrieval of sperm from the dead, which ponders whether mothers should donate eggs to their daughters and vice versa, or thinks the combination of animal/human gametes for research purposes is an excellent idea.  Safe hands?

But let us look further afield.

On March 6 this year,  ‘The Economist’ magazine grappled courageously with the issue of sex selection, with a dramatic front cover entitled ‘Gendercide’, which it explored in detail under the heading ‘The worldwide war on baby girls’ . It is almost impossible to describe the true extent and horror of what is happening in the aftermath of sex selection in countries such as China and India, where even though the practice is officially banned, girls (as embryos or in the womb or immediately after birth) have been discarded by tens of millions.

Nick Eberstadt, a demographic expert from Washington DC, describes the situation in ‘The Economist’ article as ‘the fateful collision between overweening son preference, the use of rapidly spreading prenatal sex-determination technology and declining fertility.’

Prof Wilkinson argues that over here in our nice world, there is unlikely to be a difference in numbers between those preferring boys and those preferring girls. So it is OK for us in the UK because we have a regulator and there are unlikely to be any significant demographic consequences anyway.

Sorry, Prof Wilkinson, but we believe we have a far greater duty to the world at large than to the ‘interests’ of a handful of patients in the United Kingdom who feel depressed because their family is not neatly balanced.

In particular we have a global responsibility to those struggling for equality in countries like China and India, to ensure that endemic discrimination against millions of women is eliminated during all stages of life, not least at the very beginning.

We must show total solidarity and lead by example.  A very loud ‘No’ to social sex selection.

Reading this title quickly you might question what is new in this proposal.  Read it again carefully and you will see that they are talking exclusively about embryos, and not full-term ‘saviour’ sibling babies.

CORE has always argued that the selection of a specific in vitro embryo as a potential tissue match for a sick sibling (or other family member for that matter) is an ethical nasty.  First spare a thought for the unlucky embryos who do not have the matching tissue.  They will be ‘allowed to cease to exist’ is how somebody from the HFEA euphemistically described their fatal destiny. The remaining ones, fortunate enough to escape that fate, are selected not for their own sake, but for no other reason than the benefit of somebody else.

The tissue that is sought to date in ‘saviour’ sibling arrangements is the cord blood discarded at the birth of the designed baby, but the harvesting of bone marrow and liver tissue are already a discussed possibility for the future. Or even a kidney. After all, some are saying, nature has kindly provided us with two of these organs and we do not necessarily need the second one.  UK legislation has recently left some of these options open.

We have drawn attention to the huge psychological burden this practice puts on the ‘saviour’ in question, especially if the therapy is not successful and the older child is not cured.  And if the sick child were to have a later relapse and tissue other than cord blood is required, what are the implications for the donor?  Bone marrow extraction hurts, and a kidney cannot be removed painlessly. But could the ‘saviour’ ever refuse?

The assurance was always that the resulting baby would be loved for its own sake, an argument we find difficult to accept; he or she would inevitably know that they were in this world thanks primarily to the original selection process which was based on tissue-matching qualities alone. Other  proponents like to argue, pragmatically or cynically, that whatever else it is always better to be born than not.

But with this latest proposal from Monash University in Victoria, these previous arguments are discarded. The hype and justification about the balancing act between tissue from one sibling and gratitude from the other is laid aside as the scientists have now come up with a new proposition.

Why actually bother implanting the chosen embryo, with the risk that the pregnancy does not go to term, or the worry that the sick child gets worse while the pregnancy continues?  Why not simply select the ‘saviour’ embryos and not bother with implantation at all.  Instead turn them directly into embryonic stem cells and hey presto you have instant therapeutic tissue, without the discomfort and time wasting of attempted pregnancies and complicated deliveries.

This is currently just a proposal, and any presumption that it is easy to develop embryonic stem cells, and that these could be used for therapeutic purposes, is highly hypothetical.  Scientific history is showing that real therapy deriving from the use of embryonic stem cells is proving extremely unlikely, but this is, nevertheless, a very good example of further goal post shifting in the ethics of assisted reproduction.

The authors even suggest that if destructive research on human embryos is already permitted in many countries worldwide, would this not be a more ethical solution given that the embryos would be sacrificed not in the interests of academic research but for the direct benefit of others?

Once the human embryo is viewed simply as a commodity, a means to any end, and not accorded the rightful status of a unique human being, it is obvious that arguments can be made to defend any practice whatsoever.  That ruthless slippery slope …

The abstract to the article in Reproductive BioMedicine Online ends with the following chilling conclusion:

‘While the creation of saviour embryos would involve a significant shift in the rationale for IVF and PGD, it is suggested here that the urgent need of an existing individual should be prioritised over any obligations that might exist in relation to the creation or destruction of human embryos.’

References:

www.journals.elsevierhealth.com/periodicals/rbmo/current

Reproductive BioMedicine Online (2010) 20, 667–674

Saviour embryos? Preimplantation genetic diagnosis as a therapeutic technology

Robert Sparrow a,*, David Cramb b,a Centre for Human Bioethics, Faculty of Arts, Monash University, Vic. 3800, Australia; b Monash Immunology and Stem Cell Laboratories, Faculty of Medicine, Nursing and Health Sciences, Monash University, Vic. 3800, Australia * Corresponding author.E-mail address: Robert.Sparrow@arts.monash.edu.au (R Sparrow).

CORE has commented on the vulnerability of the women selling their eggs and recommends that you read the attached witness statement from a woman seriously affected by the process, and which was part of evidence given at a Kansas Senate Hearing recently.

For those interested we have collected the testimonies of other egg donors in the United States. Please e-mail…

The number of procedures required for a trainee to reach proficiency in embryo-transfer is unknown. A new study* attempted to determine the learning curve of embryo-transfer by monitoring the pregnancy rates (PR) per transfer, carried out by five trainees. A PR of 40% was chosen to define adequate performance, whilst a PR of 20% was considered inadequate.

This study raises concerns about the principle of using both embryos and patients in human trials. Whilst all patients gave informed consent to the procedures, the result of the study indicated that up to 99 embryo transfers were being performed before trainees reached an adequate level of performance.

CORE comments:
This research demonstrates an increasingly cavalier attitude towards the treatment and use of human embryos, with in this instance the training of embryologists clearly overriding the rights of the embryo.

*How soon can I be proficient in embryo transfer? Lessons from the cumulative summation test for learning curve (LC-CUSUM)
Human Reproduction, Vol. 25, No. 2 pp. 380 – 386, 2010
L Dessolle1, T Fréour1, P Barrière1, M Jean, C Ravel, Emile Daraï and David J. Biau

http://humrep.oxfordjournals.org/cgi/content/abstract/25/2/380

Breakthrough in Ethical Stem Cell Research

Human term placenta-derived cells continue to demonstrate promise in the field of regenerative medicine. The authors of this article* maintain that ongoing comparisons about the potentiality and characteristics of cells are essential to promote constant improvement in cell therapies. A better understanding of basic disease mechanisms is also crucial to tailoring stem cell therapy.

In March 2009 a workshop entitled ‘Placenta-derived stem cells for treatment of inflammatory diseases: moving toward clinical application’ was hosted in Brescia, Italy. The aim of the event was to update findings on basic inflammatory mechanisms with particular focus on the potential for placenta-derived cells to treat inflammatory diseases. Scientists are now assessing the regulation required to prepare these proposed treatments for clinical application.

CORE comments:
Successful advances in regenerative medicine are consistently favouring ethical stem cell treatments. The latest developments utilising placenta-derived cells demonstrate that individually tailored cells are the best option for addressing disease-specific clinical needs. CORE commends the establishment of an International Placenta Stem Cell Society (IPLASS) in September 2009, which will support research in this auspicious field.

* Toward Cell Therapy Using Placenta-Derived Cells: Disease Mechanisms, Cell Biology, Preclinical Studies, and Regulatory Aspects at the Round Table
Stem Cells and Development. February 2010, 19(2): 143-154.
O Parolini, F Alviano, I Bergwerf, D Boraschi, C De Bari, P De Waele, M Dominici, M Evangelista, W Falk, S Hennerbichler, D C. Hess, G Lanzoni, B Liu, F Marongiu, C McGuckin, S Mohr, M Luisa Nolli, R Ofir, P Ponsaerts, L Romagnoli, A Solomon, M Soncini, S Strom, D Surbek, S Venkatachalam, S Wolbank, S Zeisberger, A Zeitlin, A Zisch, C V. Borlongan.

http://www.liebertonline.com/doi/abs/10.1089/scd.2009.0404

Controversy over new NIH Guidelines: Do Gamete Donors Realise What They’re Consenting to?

New guidelines issued by the National Institutes of Health (NIH) in the United States*, in relation to human embryonic stem cell (hESC) lines, present a controversial policy decision on the issue of informed consent for gamete donors. The regulations are expected to substantially increase the remit of hESC lines eligible for federal funding. Guidelines stipulate that whilst informed consent is required from embryo donors for derivation of hESC lines, third party gamete donors used to create the embryos are not subject to such consent.

CORE comments:
We are extremely worried by the ethical issues raised in this article. IVF gamete donors will sign forms giving legal authority to patients to determine the destiny of any embryos created using their gametes, without having any real idea of what the future usage might entail. This may include options that were not specifically mentioned to the donor. For example the donor may personally object to hESC research but is not told, and therefore does not appreciate, the options available to the IVF patient.

Likewise using embryos for research without permission of third-party oocyte donors could fail to respect donors as persons, breaching a fundamental principle of bioethics. The terms of the NIH guidelines clearly need immediate revision to accommodate the complex issues of informed consent.

*NIH Guidelines for Stem Cell Research and Gamete Donors
Science 19 February 2010:
Vol. 327. no. 5968, pp. 962 – 963
B Lo, L Parham, M Cedars, S Fisher, E Gates, L Giudice, D Gould Halme, W Hershon, A Kriegstein, R Rao, C Roberts, R Wagner

http://www.sciencemag.org/cgi/content/summary/327/5968/962

First item on the agenda was the appointment of Alan Doran as permanent Chief Executive of the HFEA. By way of initiation, Doran took the bold step of broaching the explosive ‘egg raffle’ story which hit the headlines last week. Alan Thornhill, a serving member of the Authority and also Scientific Director of the London Bridge Clinic at the centre of the controversy was briefly asked to leave the meeting whilst the matter was discussed. Goodness knows why given that it was a public meeting anyway.

We were informed that the story had generated around one thousand extra hits on the HFEA website the day after it broke. In a particularly lame reproach, Doran pronounced that “this approach sits uncomfortably with the ethos in this country”. He then made something of a U-turn with the conciliatory statement that “the Centre says there was no lottery… but a patient was selected at random”. Thus concluded the super-confidential business of the day, which will no doubt be readily available for all to access in the Authority minutes.

A recurrent theme of the meeting, coinciding with the release of the Budget, was a fear that quangos like the HFEA would be rigorously scrutinised by political parties and the media over funding. This did not seem to deter discussions about translating patient information into 12 other languages at £4,000 a turn, or an £800,000 budget for “one-off projects” such as improving records management and attitudes polling, or an initiative to re-design and distribute 300,000+ eye-catching leaflets advertising fertility treatment.

However of major concern to CORE was the confirmation that the Authority will be launching a review into its policies on donation. Murmurings to that effect have been circulating for months but were made official at the meeting. Now there is a 12-month plan, a committee and yet another budget in place. With an estimated cost of over £82,000 for the exercise, we wonder whether it would not be more economical for the HFEA to simply announce immediately its inevitable policy to increase compensation for egg donation. How to justify the increase could come once payment for donor egg treatments in the UK starts pouring in.

Papers for the meeting extended to some 121 pages, and these are all available on the HFEA website. Much of the day was dedicated to business plan speak and analysis, which is not of specific interest to CORE.

The Ethics Licensing Panel Review (Item 7 on the morning agenda) is well worth looking at. It is alarming to read that “some of the panel members currently lack experience and familiarity with this kind of role. Whilst the main panellists are inexperienced but generally competent, we are concerned that some of the alternates appeared out of their depth with the level of decision making and knowledge required.” These are the good folk authorised to issue licences for testing new PGD conditions and HLA tissue typing!

Conclusions:

Will any official action be taken by the Authority against the London Bridge Clinic?

Or for that matter against the Glasgow Centre for Reproductive Medicine, which has similarly hit the headlines for its involvement in fertility tourism involving human eggs?

First item on the agenda was the appointment of Alan Doran as permanent Chief Executive of the HFEA. By way of initiation, Doran took the bold step of broaching the explosive ‘egg raffle’ story which hit the headlines last week. Alan Thornhill, a serving member of the Authority and also Scientific Director of the London Bridge Clinic at the centre of the controversy was briefly asked to leave the meeting whilst the matter was discussed. Goodness knows why given that it was a public meeting anyway.

We were informed that the story had generated around one thousand extra hits on the HFEA website the day after it broke. In a particularly lame reproach, Doran pronounced that “this approach sits uncomfortably with the ethos in this country”. He then made something of a U-turn with the conciliatory statement that “the Centre says there was no lottery… but a patient was selected at random”. Thus concluded the super-confidential business of the day, which will no doubt be readily available for all to access in the Authority minutes.

A recurrent theme of the meeting, coinciding with the release of the Budget, was a fear that quangos like the HFEA would be rigorously scrutinised by political parties and the media over funding. This did not seem to deter discussions about translating patient information into 12 other languages at £4,000 a turn, or an £800,000 budget for “one-off projects” such as improving records management and attitudes polling, or an initiative to re-design and distribute 300,000+ eye-catching leaflets advertising fertility treatment.

However of major concern to CORE was the confirmation that the Authority will be launching a review into its policies on donation. Murmurings to that effect have been circulating for months but were made official at the meeting. Now there is a 12-month plan, a committee and yet another budget in place. With an estimated cost of over £82,000 for the exercise, we wonder whether it would not be more economical for the HFEA to simply announce immediately its inevitable policy to increase compensation for egg donation. How to justify the increase could come once payment for donor egg treatments in the UK starts pouring in.

Papers for the meeting extended to some 121 pages, and these are all available on the HFEA website. Much of the day was dedicated to business plan speak and analysis, which is not of specific interest to CORE.

The Ethics Licensing Panel Review (Item 7 on the morning agenda) is well worth looking at. It is alarming to read that “some of the panel members currently lack experience and familiarity with this kind of role. Whilst the main panellists are inexperienced but generally competent, we are concerned that some of the alternates appeared out of their depth with the level of decision making and knowledge required.” These are the good folk authorised to issue licences for testing new PGD conditions and HLA tissue typing!

Conclusions:

Will any official action be taken by the Authority against the London Bridge Clinic?

Or for that matter against the Glasgow Centre for Reproductive Medicine, which has similarly hit the headlines for its involvement in fertility tourism involving human eggs?