Update on Life Issues - October 2018


Decriminalisation of abortion in the UK

On Tuesday 23 October, yet another Ten-Minute Rule Bill on this topic was debated at Westminster, this time in the name of Diana Johnson MP.  Though her Bill appeared to be about bringing abortion access to Northern Ireland, in reality it would remove most of the legal safeguards around current abortion practice in Wales, Northern Ireland and England.  This is a step too far.  Such a radical proposal has no place in the UK.  While Ten-Minute Rule Bills are unlikely to become law, they can, especially if they go to a vote, have an important symbolic significance.  And so it came to pass that at 12.39 on Monday 23 October 2018, Diana Johnson MP spoke.  Then Fiona Bruce MP responded.  Then at 12.59 the House voted – the Ayes, 208 and the Noes 123.  Oh no!  How could that be?  The Second reading of this Abortion Bill will take place on Friday 23 November. [update: As expected, a number of MPs objected to the Bill, so it failed to pass at Second reading on 23 November.  It is therefore very unlikely to progress any further in the current Parliamentary session, though officially the Bill is to be read a Second time on Friday 25 January 2019.]


The very next day, Wednesday 24 October, an amendment, tabled by Stella Creasy MP and Conor McGinn MP, to the Northern Ireland (Executive Formation and Exercise of Functions) Bill, which would have fast-tracked abortion and same-sex ‘marriage’ in Northern Ireland, was abandoned.  Instead, MPs were presented with a ‘new clause 7’, which stated that current laws preventing abortion and same-sex 'marriage' in Northern Ireland are incompatible with human rights legislation.  This was approved by 207 vs. 117 and added to the Bill as clause 4.  The entire Bill was then overwhelmingly approved (344 vs. 26) to be read a Third time.  It now passes to the House of Lords to be debated on Tuesday 30 October.

On 30 October, the Northern Ireland Bill duly entered the House of Lords.  Its primary purpose has always been to seek plans to restore the power-sharing Executive in Northern Ireland, clarifying the role of civil servants.  During its Committee stage, peers debated the Bill and notably Lord Adonis tabled Amendment 10, ‘The guidance may direct departments after 1 May 2019 not to enforce sections 58 and 59 of the Offences against the Person Act 1861’ and Amendment 11, which would have legalised same-sex ‘marriage’ in the Province.  In the event, Amendment 10 was withdrawn and 11 was not moved.   During that Tuesday night, the House completed the Second reading, Committee and Report stages, as well as the Third reading.  The Bill was finally passed and, as both Houses had agreed the text, it received Royal Ascent on Thursday 1 November.

Neither of these Bills changes current abortion law.  The second Bill requires the Secretary of State for Northern Ireland to provide guidance to civil servants and to produce quarterly reports to Parliament on the supposed incompatibility between human rights law and Northern Ireland law on abortion and same-sex ‘marriage’.  The government is now under considerable pressure to act.  This is despite a recent ComRes poll of 1,863 people in England and Wales which revealed that when offered the choice of either the status quo, tighter restrictions on abortion, or making abortion available on demand, or for any reason up to 24 weeks, just 21% of women and only 26% of men would support the latter option.  Significantly, a total of 67% of women favoured either the status quo, or a more restrictive abortion regime.  The Westminster Bills are therefore out of step with the general public’s thinking.  In other words, the people don’t want abortion to be decriminalised.  But make no mistake, the pro-abortionists are on a roll.


Abortion law in Northern Ireland

The 1967 Abortion Act does not apply to Northern Ireland.  In effect, abortions in the Province are illegal in all but exceptional medical and mental health circumstances.  That restriction sticks in the craw of many, including Sarah Ewart.  In early October, she applied for a judicial review, seeking a declaration of incompatibility with human rights law in cases of fatal foetal abnormalities.


In June, a majority of Supreme Court judges said the Northern Ireland ban on terminations in cases of rape, incest or fatal foetal abnormality needed ‘radical reconsideration’ because the current legal framework was incompatible with human rights laws.  However, the Supreme Court dismissed the legal challenge by the Northern Ireland Human Rights Commission by a narrow majority over a seeming technicality because it said it had no jurisdiction to consider the case because there was no actual or potential victim of an unlawful act involved in it.


It was 5 years ago, that Ms Ewart travelled from Northern Ireland for a termination in England after a 20-week scan revealed that her baby had anencephaly, meaning that the brain was not developing normally and that the baby would either die before being born, or shortly afterwards.  Ms Ewart attended the Belfast High Court on Monday 1 October to seek leave to apply for a judicial review of the current laws.  There are four respondents in the case, Northern Ireland’s Secretary of State Karen Bradley, Northern Ireland’s Department of Justice, the Department of Health and the Executive Committee.  This ongoing case is being heard by Mr Justice McCloskey.


Abortion reversal

The two-pill medical abortion method means that women, up to 10 weeks into their pregnancies, first, take a dose of mifepristone, which blocks the ‘pregnancy hormone’, progesterone.  This is then followed within 48 hours by a dose of misoprostol, a prostaglandin that causes cervical dilation and uterine contractions, leading to expulsion of the dead embryo or foetus.  But what happens if a woman changes her mind after taking the first pill?  Can she rescue her pregnancy?


Evidence from the US suggests that many ongoing medical abortions can be reversed.  This is controversial stuff.  Currently, four States – Arkansas, Idaho, South Dakota, and Utah – require abortion providers to tell their patients about reversal treatment which involves administering repeated doses of progesterone, either orally or intramuscularly.


The man behind the reversal procedure is a San Diego doctor, George Delgado.  Until recently the only supporting evidence for reversal was his 2012 paper which documented its effectiveness in only seven pregnancies.  In April, Delgado and six collaborators published more results as Delgado et al., (2018) ‘A case series detailing the successful reversal of the effects of mifepristone using progesterone’ in Issues in Law and Medicine 33: 3-14.  It reports on 754 women who requested the treatment in the US between 2012 and 2016.  After a number of exclusions for various reasons (lost contact, changed minds, and so on) there were 547 patients who had 257 births.  So, the overall rate of a pregnancy continuing rate was 47%.  Not overwhelmingly successful, but better that the 25% of women who have been reported to give birth if they do nothing following the administration of mifepristone alone.


The procedure has not gone unchallenged.  Abortionists complain about the safety and efficacy of the treatment and about a lack of research evidence.  Of course, at this early stage, the work depends on observational case studies rather than a rigorous randomized placebo-controlled trial, which would, in any case, be unethical.  Essentially, critics say, it encourages women to use ‘an unproven and experimental therapy’ in an unmonitored research experiment.  And they also maintain that State laws which mandate doctors to inform their patients about the reversal procedure are creating ‘a disturbing intrusion into the relationship between physicians and their patients.’  Some even carp that the journal, Issues in Law and Medicine, has ties with an anti-abortion group.


Delgado and his co-authors conclude that the reversal procedure ‘appears to be both safe and effective.’  Their 2018 paper closes with a look ahead, ‘We propose that further research employing randomized controlled trials comparing progesterone doses and routes of administration are needed to confirm which mode of delivery, dose and duration of progesterone therapy is most efficacious and carries the least burden for the patient.’  This story will run and run.


Abortion pills at home

In August, the UK Government agreed that women in England could take the second abortion pill, misoprostol, at home.  Some described the move as ‘risky and reckless’.  The change follows considerable pressure from a number of medical bodies, such as the Royal College of Obstetricians and Gynaecologists (RCOG) and groups like the British Pregnancy Advisory Service (BPAS).  The Scottish government approved a similar measure in October 2017, and the Welsh government followed suit in June 2018.


Section 1 (3) of the 1967 Abortion Act requires that treatment for abortion can take place only in an NHS hospital or approved independent sector place.  NHS guidance says the courts have decided this means that both abortion pills must be taken in hospital or at an approved clinic where medical supervision is available.  However, the Government has now decided that the second pill can be taken at home, without proper medical supervision.  This is seen as merely another step towards abortion without any restrictions.


So now what happens when things go wrong?  Medical help will not be readily available.  Frightened girls may not follow the packet’s instructions correctly.  And the problem of disposal of the embryo or foetus still exists.  Is this a good move for women’s welfare, or is it a cheaper scheme for the NHS, and a victory for pro-abortionists?


Banning NIPT results

Can medical results be vetoed?  Many are calling for a ban so that parents-to-be cannot be told the sex of their baby after early blood tests, amid fears they may lead to abortions of girls.  The relatively new non-invasive prenatal test (NIPT) is used by the NHS to search for genetic conditions, such as Down’s syndrome.  However, the test can also determine gender, though NHS doctors are not meant to reveal this.  Moreover, people can pay around £150 to £200 for a NIPT privately to discover their baby's gender.  All that is required is a drop of the woman’s blood to be sent in the post.  The clinic then analyses DNA derived from the baby and the results can be sent back in a matter of a few days.


The Labour MP Naz Shah, the shadow women and equalities minister, has said it is morally wrong for people to use the test to abort pregnancies based on the outcome.  Yet thousands of British women are using an online forum to discuss the use of NIPT to determine gender.  Even so, Ms Shah has clearly stated that cultural practices in some groupings, like the South Asian community, have a preference for boys.  The Department of Health said it would continue to review the evidence.


Buffer zones and abortion clinics

Women’s groups and some MPs have been calling for protection around abortion clinics because anti-abortion protesters have been accused of harassing and intimidating staff and patients.  But in September, the home secretary, Sajid Javid, ruled out the need for so-called ‘buffer zones’.  He maintained the move was not necessary because protests took place at only a small number of facilities – about 36 of the 363 hospitals and clinics in England and Wales have reported demonstrations outside their facilities.  And because there was little evidence of harassment – gatherings, where protestors mostly prayed and handed out leaflets, were small, and displays of graphic images or blocking patients’ paths were not common.  He therefore concluded that ‘introducing national buffer zones would not be a proportionate response.’


Abortion moratorium in Russia

During this summer, hospitals in several Russian regions imposed a moratorium on abortions during the annual pro-life campaign run by Svetlana Medvedeva, the wife of the current Russian Prime Minister and former President, Dmitry Medvedev.  Faced with the lowest birth rate for a decade, the Russian government is seeking to reverse the county’s demographic crisis with a $8.6 billion plan to encourage Russians to have more babies by offering mortgage subsidies and other social programs.


The short-term abortion ban was not universally observed across Russia, but it did take place in the Far Eastern regions of Primorye and Sakha, as well as Ryazan in central Russia, during the ‘Give Me Life’ campaign, which aims to ‘protect unborn children and promote family values’.  Nearer to Moscow, the temporary ban was linked to Russia’s Day of Family, Love and Fidelity.  A Ryazan health department press release stated that, ‘It is sad to see a woman voluntarily deprive herself of the joy of motherhood.  No abortions will be carried out in hospitals during this period [between July 9 and July 15].’  The practice of placing a moratorium on abortions for two to seven days named the ‘days of silence’ has been in place since 2011.  Seven days free of abortion is better than none.


Decriminalisation of abortion in Queensland

After two days of debate in mid-October, Queensland has become the latest Australian State to decriminalise abortion.  MPs voted 50 to 41 to make the current legislation more permissive for supporters of abortion and more restrictive for its opponents.  The Termination of Pregnancy Bill removes the procedure from the criminal code and allows abortion on request up to 22 weeks.  After 22 weeks an abortion can be performed with the approval of two doctors.  The new law forces conscientious objectors to refer women to a doctor who will perform an abortion.  It also mandates bubble zones of 150 metres around clinics to protect clients from harassment.  New South Wales is now the only Australian jurisdiction where abortion is a criminal offence.


Jackie Trad, the Deputy Premier, welcomed the new law.  ‘The right of women to control their own reproduction, their own bodies, is such an important part of equality in our society,’ she said.  ‘To prioritise the rights of a foetus above that of a woman is something that I find offensive.’  Nick Dametto MP said that his wife fell pregnant while the couple were in high school and unmarried.  ‘It would have been easier to abort – no one would ever have known.  It would have changed our lives and we would be in a completely different place today.’  However, he added that he would not be able to live with the ‘killing of our unborn son or daughter’ on his conscience.  Another MP, Ted Sorensen, declared that he was a ‘survivor’ of an unwanted pregnancy.  ‘If this law were present in those days, I would not be alive to speak on behalf of all of the babies who have the right to live – and I believe that I had the right to live,’ Mr Sorensen said.  ‘I still believe that.’


Amnesty International and abortion

Amnesty International delegates from around the world gathered at a conference in Warsaw between 6 and 8 July.  They adopted new proposals to tackle what they called, ‘the devastating human rights consequences of misguided attempts by countries to criminalise and restrict abortion and to punish people for using drugs.’  Tawanda Mutasah, Amnesty International’s Senior Director for Law and Policy, declared, ‘We want to make sure we are well placed to fight for the human rights of millions of people whose lives are impacted by how governments criminalise or restrict access to abortion.’


Representatives voted to adopt an updated position on abortion that calls on states not just to decriminalise abortion, but to guarantee access to safe and legal abortion in a broad way that fully respects the rights of all women, girls and people who can get pregnant.  It will replace Amnesty International’s current position on abortion, which calls for the decriminalisation of abortion, and access to abortion in a limited set of cases, which was adopted in 2007.  Amnesty International has declared abortion to be ‘a human right’ – the organisation is now one of the biggest promoters of abortion in the world.  ‘How,’ you may ask, ‘can Amnesty claim to be a protector of human rights while supporting abortion?’  Does Amnesty not regard unborn children as human?

Assisted Reproductive Technologies

Robert Winston on IVF

On the 40th anniversary of the birth of Louise Brown, the world’s first IVF baby, on 25 July this year, Professor Lord Robert Winston, the IVF pioneer, gave an interview to The Irish Times (28 October 2018).  As ever, he was forthright.  He began, ‘The 40th anniversary is a time to celebrate the great happiness of millions of couples.  But this achievement … is also a moment for most serious reflection.’


He described a ‘major problem’ with private clinics ‘selling the dream’ to desperate couples, leading people to believe they are much more likely to get pregnant than they really are.  ‘The NHS and the HFEA websites are quite self-congratulatory if you look at them, but the reality is, people are being sucked into IVF without a full recognition of exactly how low the success rate is.  He believes that, ‘people don't always understand that the chance of getting pregnant from an individual IVF cycle in the UK still only stands at about 21% if you're under the age of 35 – the chances are even lower if you're older.’  Moreover, he maintained that the private sector is on a ‘gravy train’ with IVF with some clinics charging up to £8,000 for a single cycle of treatment.  He described the combination of ‘desperation’ from couples and ‘avarice’ from private practices as a ‘dangerous combination’.  He went on, ‘The HFEA records success rate per embryo transfer, but that in itself is misleading, because a large number of women start a cycle but never get to the embryo transfer stage, either because their ovaries don't respond or because the eggs don't fertilise.’

‘The first thing we need to change, which is something we're not doing in reproductive medicine, is to regard infertility as a symptom.  Right now, we regard it as a diagnosis and it's fundamentally wrong to offer a treatment on the basis of symptoms – because the underlying cause of the symptom will vary…’  ‘In many cases, in-vitro fertilisation is not the best [treatment] – but it's the most profit.  Unexplained infertility is a nonsense; it's a failure to make a diagnosis.  People are reluctant to go through with investigations, which in my view are justified, because at the moment, so many patients are failing to get pregnant with an IVF cycle and then get pregnant after the IVF has finished.’  And, ‘One of the important issues is making a diagnosis and finding other more effective simpler remedies, but most clinics are now geared up to do IVF, so they don't actually treat the underlying issue.’  Winston considers that, ‘one of the most common causes of infertility in women is a hormone deficiency, which is usually better treated by drugs – yet few clinics offer this.  He therefore believes it's time to make a change.

Another hazard of IVF

The list of adverse outcomes for children conceived by ARTs is growing.  The latest comes from a Swiss study entitled, ‘Association of Assisted Reproductive Technologies With Arterial Hypertension During Adolescence’ by Théo A. Meister et al., in the Journal of the American College of Cardiology (2018), 72: 1267-1274.


ARTs have previously been shown to induce premature vascular ageing in apparently healthy young children.  Could these problems persist and evolve into additional problems during adolescence and young adulthood?  Five years after initial assessments, the Swiss investigators reassessed the circulatory system of vascular function of 54 healthy, IVF-conceived adolescents (mean age 16) by testing blood vessel and cardiac health, including 24-hour blood pressure monitoring.  These were compared with 43 age- and sex-matched controls.  The results showed that the IVF-conceived children had significantly higher arterial blood pressures, and eight of the IVF children also had hypertension (clinically high blood pressure) compared with only one participant from the control group.  Thus it seems that IVF procedures can induce premature vascular ageing, which persists in apparently healthy adolescents and young adults without any other detectable classical cardiovascular risk factors, and progresses to arterial hypertension.  Emrush Rexhaj, the lead author of the study, from University Hospital in Bern, confirmed that, ‘This places ART children at a six times higher rate of hypertension than children conceived naturally.’  Although there is growing evidence that IVF somehow alters the blood vessels in children, the long-term consequences are, as yet, not known.

Another almost inconceivable IVF story

In September this bizarre case was reported in the media.  You couldn’t make it up.  A wealthy British unnamed couple, described as ‘very rich and from a notable family’ have created a ‘designer grandson’ using sperm taken from their dead son.  They wanted an heir and a grandson after their unmarried son, aged 26, tragically died in a motorbike accident.  His body lay undiscovered for two days after which a urologist retrieved some sperm and immediately froze it.  Nearly a year passed before the sperm sample was flown to the USA by a specialist medical courier to an IVF clinic in California, run by David B. Smotrich MD, FACOG, an obstetrician and gynaecologist and the founder and medical director of La Jolla IVF.


Using an American ova donor and a surrogate mother, a boy was born in 2015.  Gender-selection techniques, which are not permitted in the UK, were used to ensure a male heir.  The British couple, who were named as the legal parents, were present for the birth.  According to Dr Smotrich, the three-year-old is now living in the UK with his grandparents, who are believed to be in their fifties.  It is estimated that the procedure, including hospital fees and payments to the American ova donor and surrogate, would have cost between £60,000 and £100,000.


Dr Smotrich said he understood that the couple’s son had not given formal consent to the extraction and use of his sperm in the event of his death, suggesting that those involved in the UK may have committed a criminal act and could face prosecution.  Moreover, he stated that the couple had been ‘very specific’ about the type and calibre of the ova donor and the surrogate, insisting on subjects who matched the kind of woman they believed their son would have married in terms of physical looks, intellect and education.  Dr Smotrich said he had no ethical objections to helping the British couple and confirmed that the remaining sperm and three more embryos were in cryogenic storage.  And though he knew that gender selection is banned in the UK, he maintained, ‘It was a privilege to be able to help them.’  Apparently, he still receives Christmas cards from the family.

Born to female-only parents

The rules of mammalian reproduction have apparently been rewritten – and males can now be written out.  For the first time Chinese researchers have used the DNA of two female mice to create apparently healthy pups, some of which matured and produced their own offspring.  Baby mice derived from the combined genetic material of two fathers were also produced, but these pups lived for only 48 hours after birth.  The work was carried out by Qi Zhou and his team at the Chinese Academy of Sciences in Beijing and published in Cell Stem Cell, under the title, ‘Generation of Bimaternal and Bipaternal Mice from Hypomethylated Haploid ESCs with Imprinting Region Deletions’ by Li et al., (2018) 23: 1-12.


The headline-grabbing news was that 29 mice were successfully born to same-sex (bimaternal) female parents.  The more scientifically-oriented news was that the team identified, and overcame, factors that makes joint male-female involvement in reproduction essential for humans.  In other words, single-sex humans might be able reproduce in the future, but not any time soon.  Females of other species, such as some birds, reptiles, fish and amphibians can reproduce alone, but this is a first for mammals which customarily use sexual reproduction, namely, when a female ovum is fertilised by male sperm.


The Chinese team set out to identify the genetic process that takes place at the point of mammalian conception that demands genes from both sexes.  They focused on a phenomenon known as ‘genomic imprinting’, a mechanism that requires mammalian DNA from male and female and whereby small chemical tags attach to DNA and turn off certain genes.  They found roughly 100 such genetic tags.  Many genes that are tagged in one sex are untagged in the opposite sex.  In other words, while mammals receive a full copy of genetic material from each parent there are some genes where only a copy from a particular parent will do – this is said to be imprinted.  Combining two of the same imprinted tagged genes sequences, as would occur with same-sex parents, would lead to the death of the embryo.  To overcome this limitation, lab-grown embryonic stem cells were derived from both murine sperm and ova.  These cells have only one set of chromosomes and, like most cells, contain genetic regions that can produce the chemical tags.  Using the process of trial and error, the researchers used the CRISPR-Cas9 protocol to snip out a single letter of genetic code from three imprinted genetic regions of the female haploid embryonic stem cells (which like sperm and ova contain only one copy of each chromosome), in batches, searching for groups that could be removed without stopping the production of a healthy embryo.  They then imitated fertilisation by combining an edited stem cell from a female mouse with the ovum from another female to create pups from two mothers.  They also took a stem cell from a male mouse and injected it, along with another male’s sperm, into a denucleated ovum to create offspring from two fathers.  As a result of deleting just 3 regions, the scientists managed to produce 210 embryos which led to the birth of 29 live bimaternal mice, 7 of which went on to have their own pups.  The process was more difficult with male mice because 7 regions had to be deleted before they were able to produce 477 embryos which resulted in only 12 bimaternal pups, of which only 2 survived for up to 2 days.


This work demonstrated a new and clear way to produce offspring between same-sex mammals.  And it revealed some of the most important genetic regions that prevent mammals from reproducing without the need for two individuals of the opposite sex.  The co-senior author of the study, Qi Zhou, said, ‘We saw that the defects in bimaternal mice can be eliminated and that bipaternal reproduction barriers in mammals can also be crossed through imprinting modification.’  However, most of the embryos produced were abnormal and only a 14% bimaternal success rate and a 2.5% bipaternal rate were achieved.  And there was no convincing long-term evidence that the mice were ‘normal’.  Yet others said, ‘Creating genetic offspring from two mice of the same sex is an exciting achievement.’  Others said, ‘There is a chance in the long run that the technique could be developed to apply to humans.’  Others warned that, ‘The scientific challenges and legal barriers that would need to be to overcome to make this possible in humans are huge.’  Significant ethical and safety concerns would need to be overcome.’  And others said, ‘We should start discussing whether this is a noble endeavour.’

Towards artificial ovaries

In a bid to enable women to have children after fertility-damaging treatments, a research team led by Susanne Pors at the Rigshospitalet in Copenhagen has created an artificial ovary from human tissue and ova.  These bio-engineered ovaries were shown to keep ova alive for a few weeks.  Such a strategy raises the possibility that such ovaries, when transplanted, could recover fertility in women who have undergone treatment by chemo- and radiotherapy as well as those suffering from multiple sclerosis, beta thalassaemia, or even early menopause.  The work was presented at the 34th Annual Meeting of the European Society of Human Reproduction and Embryology in Barcelona in July.  It was entitled, ‘Early-Stage Research Shows Potential of Artificial Ovary for Fertility Preservation Without the Risk of Reintroducing Malignancy.’


Women with a cancer diagnosis can already have ovarian tissue removed and frozen and then transplanted once their treatments are over.  Thus their fertility is safely restored.  But for some high-risk patients, ovarian cancer or leukaemia can permanently damage their ovaries.  The use of artificial ovaries could be a safer option.  The protocol involves stripping ovarian tissue of cells to create a scaffold.  This is then seeded with 20 human follicles, the sacs that contain immature ova.  Such an artificial ovary implanted in a mouse enabled 25% of the follicles to survive for at least three weeks, by which time blood vessels had started to infuse the ovary, the researchers called this ‘the point of biofunctionality’.  Although this study confirms a proof of concept, scientists reckon it will be another 5 to 10 years before human trials can be undertaken.  It could also obviate IVF.  You read it here first.


Saviour siblings

It is a long time since saviour siblings were in the news headlines.  In mid-August, the news that an Australian couple, who genetically engineered their baby to become a bone-marrow donor for one of their other five children, has prompted renewed debate about designer babies.  Olivia and Andrew Densley from Melbourne spent A$100,000 (£57,000) on repeated IVF treatments before obtaining a matching embryo to save their fifth child, Fletcher, aged four, who suffers from the potentially deadly illness known as Wiskott-Aldrich syndrome.  This condition is characterised by a deficient immune system and an inability to form blood clots, causing dangerous bleeding.


A bone marrow transplant offered the only hope of cure.  The Densley family undertook a worldwide search for a matching bone marrow donor – it proved to be fruitless.  The couple then decided to create their own compatible saviour sibling.  In mid-August, their daughter, Lilliahna, was born.  The life-saving bone marrow for Fletcher will be extracted from her when she reaches 22 lb in weight.  Oh, the problems of consent, Lilliahna’s possible resentment concerning her utility, the eugenic nature of IVF-PGD and its destruction of ‘unsuitable’ embryos, the knowledge that Mrs Densley already suffered from Wiskott-Aldrich syndrome, and so on, and so on.  If you want to discuss a contentious bioethical topic, try saviour siblings. 


Genetic Engineering

Nuffield Council on Bioethics Report

Should we, or should we not, be allowed to modify human DNA in future children?  On 17 July, the UK’s influential Nuffield Council on Bioethics said yes by implicitly endorsing (p. 75) ‘heritable genome editing interventions’.  It declared (p. 96) the practice of altering the DNA of a human embryo as ‘morally permissible’ ‘in certain circumstances’ (p.158).  After 20 months of consultation with many experts in the UK and beyond, the Council’s 183-page Report, ‘Genome editing and human reproduction: social and ethical issues’ [see here], has been published.  Its main conclusion (p. 154) is, ‘We can, indeed, envisage circumstances in which heritable genome editing interventions should be permitted.’


The Council had four terms of reference (p. iv).  First, ‘To identify and define ethical questions raised by recent developments in biological and medical research that concern, or are likely to concern, the public interest.’  Second, ‘To make arrangements for the independent examination of such questions with appropriate involvement of relevant stakeholders.’  Third, ‘To inform and engage in policy and media debates about those ethical questions and provide informed comment on emerging issues related to or derived from its published or ongoing work.’  Fourth, ‘To make policy recommendations to Government or other relevant bodies and to disseminate its work through published reports, briefings and other appropriate outputs.’


The Report recommends (p. vii) that two overarching principles should guide the use of ‘heritable genome editing interventions’ for them to be ethically acceptable.  First, ‘that such interventions are intended to secure, and are consistent with, the welfare of a person who may be born as a consequence.’  Second, ‘that any such interventions would uphold principles of social justice and solidarity – by this we mean that such interventions should not produce or exacerbate social division, or marginalise or disadvantage groups in society.’


The Report further recommends that heritable genome editing interventions should be permitted only when three conditions have been satisfied.  First (p. 135), ‘there should be sufficient opportunity for a broad and inclusive societal debate.’  Second (p. 159), ‘research to establish the clinical safety and feasibility of genome editing.’  Third (p. 100), ‘measures to monitor the social consequences and to mitigate any adverse effects are in place.’


Overall, the Report states (p. xviii) that if ‘heritable germline genome editing’ were to be permitted, it should be under three controls.  First, ‘not be permitted until risks of adverse outcomes have been thoroughly assessed, and then only on a case-by-case basis.’  Second, ‘licensed and regulated under the system currently overseen by the HFEA.’  And third, ‘within the context of a carefully monitored study, with comprehensive follow-up arrangements in place.’


The Report has not gone unnoticed.  Its endorsement of human genome editing has drawn fire from several experts – including at least one who consulted on the Council's previous 2016 Report.  Critics, for example, include Stuart A. Newman, Professor of Cell Biology and Anatomy at New York Medical College, who said, ‘I'm very troubled by it.  I think it's very irresponsible of them to make that pronouncement.  I think that these methods are dangerous and in fact, there is no child there, there is basically a fertilized egg and they're saying that the child has an interest and the interest is to be experimented on.  These experiments are very chancy and there is really no guarantee that the developing embryo won't turn out more impaired than the way it started.  I really don't understand the rationale at all.’


And Dr David King, Director of Human Genetics Alert, claimed, ‘This is an absolute disgrace.  We have had international bans on eugenic genetic engineering for 30 years.  But this group of scientists thinks it knows better, even though there is absolutely no medical benefit to this whatever.  The Nuffield Council doesn't even bother to say no to outright designer babies.  The people of Britain decided 15 years ago that they don't want GM food.  Do you suppose they want GM babies?’  And Marcy Darnovsky of the Center for Genetics and Society in California, commented that the Report acknowledged that if reproductive gene editing were permitted, it would be used for enhancement and cosmetic purposes.  ‘They dispense with the usual pretence that this could – or, in their estimation, should – be prevented.  They acknowledge that this may worsen inequality and social division, but don’t believe that should stand in the way.  In practical terms, they have thrown down a red carpet for unrestricted use of inheritable genetic engineering, and a gilded age in which some are treated as genetic “haves” and the rest of us as “have-nots”.  The bottom line is all too clear.  Sadly, the Nuffield Council on Bioethics has given its blessing to an unneeded and societally dangerous biotechnology, one that could be leveraged by privileged elites seeking purported genetic improvements to ensure that their children are treated as superior to the rest of us.’


For many critics, the big issue is one of burdening future generations with possibly dangerous genomic alterations without their consent.  This they say is unconscionable.  And there is also that most vexed question about genome modification that is not for therapeutic reasons – to eliminate genes causing disorders – but for enhancement – attempting to improve a child’s intelligence or physical appearance.  Can these issues be bioethically justified?


While the Nuffield Report is purely advisory, most of its recommendations on similar topics have eventually become law in the UK.  For this reason, its advice to the British government is of global significance.  Germline engineering, as this technique is sometimes called, was for a long time the red line in biology.  Any changes made would become part of the genome of the individual, to be passed on to future generations.  The uncertainties and risks were deemed so great that it should never be attempted.  How times have changed!  Are we in danger of creating a eugenic mentality that aims to improve the gene pool, but instead creates social stigmas and social privileges for people with certain genetic qualities?


Base editing (BE)

Gene editing is currently most commonly undertaken using the CRISPR-Cas9 technique.  Base editing (dCas9) represents a different approach.  Instead of inducing a snip in DNA at the desired site, as Cas9 does, and then allowing the cell's natural repair mechanisms to re-join the DNA with random edits, dCas9 changes a single target letter without causing a break.  This is thought to result in fewer off-target effects, which could improve clinical safety.


BE was developed in 2016 by David Liu at Harvard University in Cambridge, Massachusetts.  He explained that, 'Most human genetic variants that cause disease are point mutations a single base-pair that, for whatever reason, has been changed to a different base-pair.  So we set out to take a new approach to genome editing that would be especially good at correcting point mutations.’  BE using CRISPR-dCas9 can be likened to a scalpel, whereas gene editing using CRISPR-Cas9 is more like an axe.


Base editing in action

Marfan syndrome is an autosomal dominant disorder with a wide range of symptoms, including heart problems and those affected are typically abnormally tall and slender.  It is thought to be caused by a single base change in the patient’s DNA from a 'healthy' T to a pathogenic C in a gene known as FBN1.  FBN1 codes a protein called fibrillin, which is a key component of connective tissues.  Without fibrillin these tissues do not form properly.


A team of researchers from Shanghai Tech University and elsewhere in China have reported the successful correction of this mutation responsible for Marfan syndrome in viable human embryos by base editing.  The study was published in the journal Molecular Therapy (2018, 26: 1-7) under the title, ‘Correction of the Marfan Syndrome Pathogenic FBN1 Mutation by Base Editing in Human Cells and Heterozygous Embryos’ by Yanting Zeng et al.


Healthy donor ova were fertilised by IVF with sperm from a man known to have the disease.  A total of 18 resulting embryos were injected with base-editing CRISPR-dCas9 components.  This procedure accomplished the required T-to-C change.  All of the treated embryos exhibited a change at the target site.  In 16 out of 18 instances the change was a reversion of the C back to a T, while the other two were changed, but incorrectly.  No adverse off-target effects were recorded and the editing efficiency rate was about 89%.  This apparently safe and efficient work is regarded as a pilot study providing proof of concept rather than as a clinical treatment for Marfan – that will be many years away.  Meanwhile bioethical problems abound this study used IVF and resulted in ‘heritable germline genome editing’.


Who owns CRISPR-Cas9?

We’ve been here before.  Way back in 2012, Jennifer Doudna and Emmanuelle Charpentier, researchers at the University of California, Berkeley (UC), filed a patent for their discovery of CRISPR-Cas9 and its ability to edit DNA.  Subsequently, Feng Zhang's team at the Broad Institute in Cambridge, Massachusetts used CRISPR-Cas9 to edit the genomes of eukaryotic cells and applied for a fast-tracked patent application, which was processed before UC's.  Enter the lawyers.


This situation sparked a long-running dispute, which has probably been settled on 10 September in favour of the Broad Institute.  The Court of Appeals for the Federal Circuit in Washington issued the ruling after hearing arguments in April.  UC brought the case, appealing the 2017 decision of the US Patent Trial and Appeal Board (PTAB) to award a patent to the Broad Institute.  The quarrel centred on who had the rights to charge fees for the use of this technology, which has an extremely high commercial value.  As an indication of the latter, it is thought that Broad’s legal fees have already exceeded US$10 million.


Is CRISPR-Cas9 editing safe?

Scientists from the Wellcome Sanger Institute at Cambridge have reported that in three cell types, derived from mice and humans, CRISPR/Cas9 can frequently cause extensive mutations.  Published in Nature Biotechnology (2018, 36: 765-771) the study, ‘Repair of double-strand breaks induced by CRISPR–Cas9 leads to large deletions and complex rearrangements’ by Kosicki et al., found that many of the cells had large genetic rearrangements, such as DNA deletions – often several thousand DNA letters long – and insertions – complex rearrangements of DNA sequences – equivalent to damage far greater than previously reported.


In addition, some of these changes were too far away from the target site to be seen with standard genotyping methods.  The researchers stressed that standard tests for detecting DNA changes may miss finding these sites of genetic damage.  Obviously, such unexpected damage could lead to dangerous changes in some cells which would have safety implications for future gene therapies using CRISPR/Cas9.  As the researchers warn, ‘The observed genomic damage in mitotically active cells caused by CRISPR–Cas9 editing may have pathogenic consequences.’  Clearly, these unwanted edits are a problem and their cause deserves more attention.


Polygenic scores

Here’s something new.  For the last 20 or so years, researchers have struggled to explain numerically how likely we are to suffer from heritable conditions, such as heart disease, diabetes and schizophrenia.  Polygenic scores add together the infinitesimal contributions of tens of millions of locations, or spots, on our genome to create some of the most powerful genetic diagnostics to date.  Or, at least, that is the hope.


One of the maestros behind this innovative science is Sekar Kathiresan, a geneticist at the Massachusetts General Hospital in Boston.  The polygenic risk scores he has developed are part of a cutting-edge approach in the hunt for the genetic contributors to common diseases. He has been known to look at as many as 6.6 million spots to calculate a person’s risk of developing, for example, coronary artery disease.  Kathiresan has found that combinations of single DNA-letter differences from person to person in these locations can help to predict whether someone will succumb to one of the leading causes of death worldwide.  It is needle-in-a-haystack science, and it is anyone’s guess what the majority of all those As, Cs, Ts and Gs are doing.  Nevertheless, Kathiresan maintains that, ‘you can stratify people into clear trajectories for heart attack, based on something they have fixed from birth.’


This is big data science.  Large data repositories, such as the UK Biobank, already contain vast quantities of health information alongside DNA data from hundreds of thousands of people.  Now such data have been analysed from more than a million participants with the aim of detecting tiny, tiny differences and effects.  Supporters say that polygenic scores could be the next great stride in genomic medicine, but the approach has generated considerable debate.  How might the scores be used, advantageously and disadvantageously?  How will participants interpret the complex and sometimes equivocal results?  Are the databases too limited in ethnicity and geographical diversity?


Whatever the bioethical quandaries, the science is already out of the lab and into the home – at least one US company is offering consumer testing.  At the end of December 2017, Myriad Genetics became the first large diagnostics company to introduce a polygenic risk test to the US market.  Called riskScore, it measures 86 DNA variants and combines them with a person's family and medical history, to determine a woman's five-year and lifetime risk of breast cancer.


So, here is the new term to learn.  It is called ‘genome-wide association study’, or GWAS for short.  GWAS has two main applications.  First, it can help understand the underlying biological architecture of disease and human variation.  Second, it can predict who is most at risk of developing conditions, like heart disease and diabetes, potentially even before birth.  And currently all that is required is a cheek swab.  So GWAS is 'hot-button' science.  In 2007, there were 240 published research papers that mentioned GWAS, in 2017, the figure was more than 3,800.


Gene editing of human embryos

Japan is set to allow the gene editing of human embryos.  An expert panel, representing the country’s health and science ministries, released new guidelines in September.  Although the country regulates the use of human embryos for research, until now there have been no specific guidelines on using novel tools, such as CRISPR–Cas9, capable of making precise DNA modifications.


The new guidelines will allow for research to be carried out on early-stage embryos, with scientists hoping to gain insight into early human development and perhaps eventually fix genetic mutations that cause inherited diseases.  As ever, bioethicists are concerned that the technique could be used to alter the embryos for non-medical reasons.  While the guidelines would ban the manipulation of human embryos for reproduction, they will not be legally binding.  Currently these proposed guidelines are open for public consultation and their implementation is expected in early 2019.


It was in April 2015, that researchers in China first reported using CRISPR-Cas9 to edit human embryos.  Such editing is still banned in most countries, though China, the United States, Sweden and the UK sanction it restrictions in the latter were relaxed in February 2016.


Gene-editing human sperm

Would it be more bioethically acceptable to gene edit reproductive cells, namely, sperm and ova, rather than human embryos?  If so, then there should be encouragement for the recent work published by Diane Choi and her team at Weill Cornell Medicine in New York City.  In a poster (P-794) entitled, ‘Feasibility of CRISPR-Cas9 on the human sperm cell’ and presented at the annual meeting of the European Society of Human Reproduction and Embryology during July 2018 in Barcelona, the US scientists used CRISPR-Cas9 editing to directly target a gene associated with male infertility in mature sperm cells.  They found that a single 1100-volt electrical pulse, for just 50ms duration allowed the CRISPR components to break through the tough exterior of the sperm cells without killing them.  Although sperm motility was reduced by half, as the strongest and healthiest sperm had been selected, their swimming ability was still efficient enough to be able to fertilise an ovum without the need for ICSI.


In theory, all single gene disorders transmittable by the male could be treated if CRISPR-Cas9 could be successfully used on sperm.  An additional advantage of targeting sperm rather than embryos is that the cells of the latter are dividing rapidly so that the editing process may be incomplete leading to mosaicism.  Moreover, if successful, this approach could lead to treating genetic diseases passed on by fathers, such as cystic fibrosis, sickle cell anaemia and muscular dystrophy.


Stem–cell Technologies


California dreamin’

The Mamas and the Papas recorded a song with this title in 1965 – yes, I’m a true child of the Sixties.  But now, in 2018, California has been caught dreamin’ in another context.


Back in 2004, the Californian dreamers voted 59% to 41% for Proposition 71, an amendment to the State constitution that created the California Institute for Regenerative Medicine (CIRM).  It would cost the Sunshine State taxpayers US$3 billion with another $3 billion in interest.  But the dreamers were promised stem-cell treatments, especially those using embryonic stem cells, beyond their wildest dreams.  Now the CIRM’s funding has nearly run out and its supporters plan to ask voters to authorise another $5 billion in funding in 2020.


OK, so the money has been mostly spent.  On what?  And what about those promises?  The easily-led Californians were told that new, life-changing therapies would emerge in just a few years.  And the project would create thousands of jobs and return the State's investment more than seven times over.  Maybe.  But, of course, it has not happened that way.  Instead no federally-approved treatments have been produced.  And without marketable therapies, the scheme will be a financial disaster.  CIRM has funded nearly 50 clinical trials, but just four have so far been completed.  The expected $1.1 billion in royalties within 35 years has amounted to just one single payment of $190,000.  So what went wrong?  In short, embryonic stem-cell research was over-hyped.  It did not deliver, it never would, and it never will.  Other approaches, using adult and induced pluripotent stem (iPS) cells have been so much more promising and therapeutic.  The Californians made the wrong choice.  They believed the propaganda.  They expected a rich return and rapid remedies.  Their dreams have not come true.  They are not dreamin’ so much now!


Parkinson’s and iPS cells

At the end of July, researchers in Japan announced the launch of a clinical trial to treat Parkinson’s disease with neurological material derived from induced pluripotent stem (iPS) cells.  Parkinson’s disease results from the death of specialized cells in the brain that produce the neurotransmitter, dopamine.  A lack of dopamine leads to a decline in motor skills, resulting in difficulty walking and involuntary trembling.  As the disease progresses it can lead to dementia.


The trial strategy is to derive dopaminergic progenitors from iPS cells and inject them into the putamen, a round structure located at the base of the forebrain.  Surgeons will drill two small holes through the patient’s skull and use a specialized device to inject roughly 5 million reprogrammed cells.  The trial is being led by Jun Takahashi, a neurosurgeon at Kyoto University's Center for iPS Cell Research and Application (CiRA), in cooperation with Kyoto University Hospital.  Studies with animals have shown that the progenitors can differentiate into dopaminergic neurons inside the body and then engraft into the brain. Takahashi’s group reported last year that monkeys with Parkinson’s had shown significant improvements with this treatment, lasting for at least 2 years.  The team plans to recruit seven human patients and follow them for 2 years post-injection.


This is the third human trial using iPS cells approved in Japan.  The first, using retinal cells derived from iPS cells to replace eye tissue damaged by age-related macular degeneration (AMD), was launched in 2014 and is being led by Masayo Takahashi of the RIKEN Center for Developmental Biology in Kobe, who just happens to be Jun Takahashi’s wife.  The AMD treatment was initially reported to be safe, though there has been one reported adverse event.  Earlier this year, a team at Osaka University in Japan won conditional approval for an iPS cell-based study for ischaemic heart disease.


Blindness and iPS cells

Scientists have reversed congenital blindness in mice by reprogramming supportive cells in the retina, called Müller glia, into rod photoreceptors.  Enabling the eyes to regain their self-healing properties could produce regenerative therapies for blinding diseases, such as age-related macular degeneration and retinitis pigmentosa – it could give hope to millions suffering from vision impairment.


Researchers have long studied the regenerative potential of Müller glia because in other species, such as zebrafish, they can divide in response to injury and turn into photoreceptors and other retinal neurons.  Zebrafish, because they retain their retinal stem-cell population so, unlike mammals, they can regain vision after severe retinal injury.  In the laboratory, scientists plan to coax mammalian Müller glia to regain their cell repair machinery to behave more like fish.  But it first requires injuring the tissue, a rather counterproductive procedure.


There are many different kinds of genetic disease that cause blindness, each requiring its own treatment.  Although it remains a long way from human trials the scientists behind the latest research, published in Nature (2018, 560: 484–488) by Yao et al., and entitled, ‘Restoration of vision after de novo genesis of rod photoreceptors in mammalian retinas’, believe their technique could provide a more general way of restoring sight, irrespective of the cause of blindness.


This latest work was led by Bo Chen, director of the Ocular Stem Cell Program at the Icahn School of Medicine at Mount Sinai, New York.  His team showed that by transferring a gene into the retinal cells and then reprogramming them, they were able to restore lost photoreceptors in blind mice, which regained their vision after about six weeks.  They only restored rods, which are responsible for vision in low light.  But they believe that keeping rods will also help protect cones, the other important type of retinal cell.


Humans have the same retinal machinery, but do not have this ability to use it for some reason it is inhibited.  If the technique could turn on this human stem-cell repair function, it could help reverse the damage done by conditions like, for example, macular degeneration, which affects about half a million people in the UK.


According to Thomas Greenwell, of the US National Eye Institute, ‘This is the first report of scientists reprogramming Müller glia to become functional rod photoreceptors in the mammalian retina.  If rods can be regenerated from inside the eye, this might be a strategy for treating diseases of the eye that affect photoreceptors.’  Helen Lee, from the Royal National Institute of Blind People, said, ‘Clearly it is still at a very early stage, but at some point in the future stem-cell treatment may become part of the armoury of treatments for sight-threatening eye conditions.’


A new method for iPS cells

The addition of so-called Yamanaka factors, critical genes, has been the means of reprogramming a variety of cells into induced pluripotent stem cells (iPS cells).  For the first time, a group of scientists from Finland, Sweden and England have succeeded in converting human skin cells into pluripotent stem cells by activating the cell's own genes.  The work entitled, ‘Human pluripotent reprogramming with CRISPR activators’ was published in Nature Communications (2018, 9: 2643) by Weltner et al.


This was achieved by using CRISPR-Cas9-based gene activation (known as CRISPRa) and a blunted version of the Cas9 'gene scissors' that does not cut DNA and can therefore be used to activate gene expression without mutating the genome.  In addition, multiple genes can be targeted at the same time.  So reprogramming based on activation of endogenous genes, as opposed to Yamanaka exogenous factors, rather than overexpression of transgenes is also theoretically a more physiological way of controlling cell fate and may result in more normal cells.  Reprogramming efficiency was improved by additionally targeting a conserved Alu-motif enriched near genes involved in embryo genome activation (EEA-motif) – this is a genetic element found to regulate the earliest steps of human embryo development after fertilization.


Stem cells from umbilical cord blood

It has long been known that human umbilical cord blood (hUCB) is rich in stem cells.  Researchers from the Stowers Institute for Medical Research in Kansas City, Missouri and their collaborators from elsewhere have identified a way to expand the numbers of blood-forming, adult stem cells from hUCB.  This could make these cells available to more people, and be more readily accepted in those who undergo adult stem-cell treatments for conditions, such as leukaemia, blood disorders, immune system diseases and other types of cancers, but who cannot obtain an appropriate and available bone marrow match.


Life-saving bone marrow transplants have been the common practice for decades, but they do not work for everybody.  Only 30% of patients have a bone marrow donor match available in their families.  Moreover at least 170,000 people in the USA are expected to be diagnosed during each year with a blood cancer, such as leukaemia, lymphoma and myeloma.  Adult stem cells from umbilical cords are more likely to be a match for more people because there are fewer compatibility requirements than for a bone marrow transplant.  But adult patients need two cords' worth of blood per treatment, and there are not enough cord units available for everyone who needs the treatment.  Hence the drive to expand the stock.


The study in question is ‘Suppression of m6A reader Ythdf2 promotes hematopoietic stem cell’ by Zhenrui Li et al., and published in Cell Research (2018, 28: 904–917).


Bio-engineering an oesophagus

Around one in 3,000 babies is born each year with abnormalities of the oesophagus, usually involving either a gap between the upper and lower section, or where it does not connect with the stomach.  Scientists at Great Ormond Street Hospital (GOSH) and the Francis Crick Institute in London have grown a bio-engineered oesophagus which was successfully implanted into mice.  The work was published in Nature Communications (2018, 9: 4286) under the title ‘Multi-stage bioengineering of a layered oesophagus with in vitro expanded muscle and epithelial adult progenitors’ by Luca Urbani et al.


The team used a rat oesophagus, which they first stripped of its cells, leaving behind a collagen scaffold.  Then they seeded it with stem cells obtained from early-stage muscle and connective tissue from mice and humans, and other early rat cells, which went on to form the lining on the inside of the organ.  This use of stem cells from different species would enable the researchers to differentiate between the origins of each tissue type which developed.  Finally, 2 cm sections of the oesophagus were implanted into the abdomen of mice.


Paola Bonfanti, the group leader, said, ‘We were amazed to see that our engineered tissue had both the structure and function of a healthy oesophagus, and hooked up with nearby blood vessels within a week of transplantation.’  The sections of oesophagus were capable of muscle contraction, which is needed to move food down to the stomach.  Paolo De Coppi, co-author commented, ‘This is a major step forward for regenerative medicine, bringing us ever closer to treatment that goes beyond repairing damaged tissue and offers the possibility of rejection-free organs and tissues for transplant.'  The eventual aim would be to create bio-engineered organs from a pig oesophagus, which would be injected with a patient's own stem cells, in order to minimise the risk of rejection.


This field of bio-engineered organ transplants suffered a major setback in 2016 when a surgeon in Sweden, Paolo Macchiarini, was accused of falsifying his research.  Of nine of his patients, who received a synthetic windpipe, seven died, and the two survivors had the organ replaced with a donor trachea.  The London team say that scandal reinforced their determination to proceed cautiously.


Disgraced stem-cell researchers

What’s up with stem-cell researchers?  Are they a cohort prone to cheating?  Does their research have such potent potential that they are easily distracted by dreaming of huge grants and Nobel Prizes?  Whatever the reasons they do seem to have an extraordinary number of retractions of their research papers.


For example, Ole Petter Ottersen, the president of the Karolinska Institute in Sweden has recently ruled that seven of its researchers, including the now disgraced surgeon Paolo Macchiarini, were ‘guilty of scientific misconduct’.  In 2017, Ottersen was given the task of cleaning up the famed Institute after a scandal over bio-engineered implants damaged its reputation.  He has asked for six articles to be retracted, including two published in the Lancet.  Controversially, he included in his list one of Macchiarini’s co-workers, Karl-Henrik Grinnemo, who had initially alerted the Institute to defects in the articles as long ago as 2014.  In his retraction request for the 2011 paper in the Lancet (2011, 378:1997-2004), ‘Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study’, Ottersen stated that, ‘No ethical permit had been obtained for the underlying research.  The research was carried out without sufficient support by preclinical data, and the paper presents its data in a way that is unduly positive and uncritical.  The clinical findings reported are not supported by source data.’  Macchiarini’s three co-authors of the Review paper, ‘Engineered whole organs and complex tissues’ published in the Lancet (2012, 379: 943-952), were found not blameworthy and not guilty of misconduct. 


Yet another example of stem cell cheating has been attributed to a world-renown cardiac researcher, Piero Anversa.  He rose to prominence for his work on the regeneration of heart tissue by stem cells.  He appeared to show that the heart’s capacity for self-repair was generally underestimated.  Yet some of his critics said that the idea of regenerative stem cells existing in the heart was implausible.  Now, officials from his previous places of work, Harvard Medical School and the Brigham and Women’s Hospital in Boston, have asked that 31 of his papers be retracted from journals.  The papers in question, ‘included falsified and/or fabricated data.’  In addition, the New England Journal of Medicine has retracted one paper of Anversa’s papers and issued an ‘expression of concern’ about two others.  The NEJM retracted paper was the 2011 study, ‘Evidence for human lung stem cells’ (2011, 364: 1795-1806).

Now comes news (The Daily Telegraph, 31 October 2018) of a cover-up by stem-cell scientists based at University College London (UCL).  The team, led by Professor Martin Birchall, was proposing to conduct a multi-million pound clinical trial using tracheas, bio-engineered with stem cells, to treat patients with failing windpipes.  Their grant application was based on their experience with this novel surgery.  But they failed to disclose that two of their previous patients had died soon afterwards.  Miss Shorten, a 19-year-old, had the operation in 2010 at the Careggi Hospital in Florence, but her new trachea collapsed, she spent 6 months in intensive care and was given a plastic trachea, but she died four months later.  Miss Davison, aged 15, had undergone a tracheal transplant in 2012 at Great Ormond Street Hospital (GOSH), but it too collapsed, she suffocated and suffered irreversible brain damage and died 13 days later.  Neither of these deaths was mentioned in the grant application, in fact they were described as ‘successful’ in promotional literature.  The team’s promised £4.7m of UK funding has been withdrawn and an additional £6m EU-backed trial is now unlikely to go ahead.  How did these deceitful research workers ever receive approval for their project?  Professor Patricia Murray, a stem-cell biologist from Liverpool University, has taken a great interest in this story.  She said, ‘The reason is because they basically lied about patient outcomes and omitted adverse outcomes.  If they had been accurate about what happened and told the truth, I don’t think they would have got the funding.’  Various investigations into these matters are ongoing.

It is to be hoped that this sad litany of stem cell dishonesty has come to an end.  But that seems a somewhat forlorn hope.  Scientists, like many others, can be driven people, and both internal and external pressures to continually produce astounding results, to win prizes and to secure grants, can make ‘cutting corners’ very tempting.  And cutting corners can so easily grow into bold-faced cheating.  When science becomes fraudulent, we all suffer.

Euthanasia and Assisted Suicide


Clinically-assisted nutrition and hydration (CANH)

On Monday 30 July, Lady Black delivered a landmark judgement of the Supreme Court with profound implications on how we value human life.  It removed the previous requirement to obtain legal sanction for every decision to withdraw clinically-assisted nutrition and hydration (CANH) from people who lack capacity through ‘prolonged disorders of consciousness’ (PDOC).  Prior to this ruling, based on the 1993 case of Anthony Bland, brain-damaged patients in a persistent vegetative state (PVS) or a minimally conscious state (MCS) were able to have their cases heard by the Court of Protection.  This sensible pathway was enshrined in the 2005 Mental Capacity Act.  PVS and MCS patients are typically regarded as unaware, though they can breathe without the use of a ventilator and they require food and fluids to be administered by tube, known as CANH.  If CANH and good care are provided PVS and MCS patients may live for many years.  Some patients may even regain a degree of awareness.  This new Supreme Court ruling effectively deprives these patients of the opportunity to recover and sets a dangerous precedent.


It is difficult to understand how the best interests of the patient can be served by withdrawing CANH.  Yet the Supreme Court has now said that it is acceptable for the patient to ultimately die as a result of starvation and dehydration, crucially, without applying to the Court of Protection.  In other words, it will not be their underlying condition which would be the cause of death.  Yet, in welcoming the move, the British Medical Journal stated, ‘This represents the culmination of a paradigm shift over the past six years, moving from a focus on a patient’s diagnosis and level of awareness to a focus on the patient’s best interests.  In effect it returns clinical decision-making to the clinical team and patients’ families.’


The judgment confirms that there is now, ‘no requirement in domestic law for an application to the court’ and that, ‘the combined effect of the 2005 Mental Capacity Act, the Mental Capacity Act Code, and the professional guidance, particularly that emanating from the General Medical Council’ provides a sound, protective regulatory framework.  Lady Justice Black concluded that, ‘Existing law and guidance are sufficient to ensure good practice, primarily through using the best interests process.’


Starving and dehydrating patients for a week or two until they die can that really be in anyone’s best interests?  And it is estimated that there are around 24,000 people in the UK in PVS and MCS.  Some will see this ruling as compassionate and humane, others as the removing of a vital legal safeguard for a highly vulnerable group.


The case of Mr Y

The Supreme Court ruling, discussed above, was triggered by an appeal on behalf of Mr Y, a banker.  The following is verbatim from the Press Summary published by the Supreme Court on 30 July 2018.


‘The question in this appeal is whether a court order must always be obtained before clinically assisted nutrition and hydration (“CANH”), which is keeping a person with a prolonged disorder of consciousness (“PDOC”) alive, can be withdrawn, or whether, in some circumstances, this can occur without court involvement.’


‘In June 2017 Mr Y, an active man in his fifties, suffered a cardiac arrest which consequently led to extensive brain damage due to lack of oxygen.  He never regained consciousness following the cardiac arrest and required CANH to keep him alive. His treating physician concluded that, even if he regained consciousness, he would have profound disability and would be dependent on others to care for him for his remaining life.  A second opinion from a consultant and professor in Neurological Rehabilitation considered Mr Y to be in a vegetative state without prospect of improvement.  Mrs Y and their children believed that he would not wish to be kept alive given the doctors’ views about his prognosis.  The clinical team and the family agreed that it would be in Mr Y’s best interests for CANH to be withdrawn, which would result in his death within two to three weeks.’


‘On 1 November 2017, the NHS Trust sought a declaration in the High Court that it was not mandatory to seek the court’s approval for the withdrawal of CANH from a patient with PDOC when the clinical team and the patient’s family agreed that it was not in the patient’s best interests to continue treatment and that no civil or criminal liability would result if CANH were withdrawn.’


‘The High Court granted a declaration that it was not mandatory to seek court approval for withdrawal of CANH from Mr Y where the clinical team and Mr Y’s family were in agreement that continued treatment was not in his best interests.  The judge granted permission to appeal directly to the Supreme Court. In the intervening period Mr Y died but the Supreme Court determined that the appeal should go ahead because of the general importance of the issues raised by the case.’


‘The Supreme Court unanimously dismisses the appeal. Lady Black gives the sole judgment with which the other Justices agree.’

Backdoor euthanasia in UK

The British Medical Association (BMA) is studying whether doctors should be allowed to ‘pull the plug’ on patients with severe dementia or other degenerative diseases.  Confidential draft guidelines, detailed in a 77-page document, have been circulated after the recent Supreme Court ruling that NHS staff and officials no longer need a court's permission to withdraw CANH (clinically-assisted nutrition and hydration) from a patient who is incapacitated and unable to speak or feed themselves, but who are not imminently dying.


Furthermore, the BMA is suggesting that doctors should be able to end the lives not only of patients in vegetative or minimally conscious states (VS or MCS), but also of those with common degenerative conditions, like advanced dementia, provided that it is in the patient’s best interest.  Other patients who could have CANH withdrawn would include stroke patients and patients with ‘rapidly progressing brain injury’.  The proposed guidelines would include, … those patients who have a recognised degenerative condition – such as advanced dementia, Parkinson's or Huntington's disease – that is likely to result in the patient being unable to take sufficient nutrition orally.’  The consultation also states, ‘Due to the degenerative nature of their condition, these patients are on an expected downward trajectory and will inevitably die, usually as a result of their underlying condition, although perhaps not imminently and could, potentially, go on living for many years.’


This smells like euthanasia by the backdoor.  UK parliaments have consistently refused to legalise euthanasia or assisted suicide for people with such conditions.  But now the BMA is considering that ending these lives by starvation and dehydration, rather than blatantly with a lethal injection or by drinking poison, is perfectly acceptable.  How is this different from up-front euthanasia?  It is thought that these guidelines will not be open for public consultation before their publication in the autumn.  If you can’t feed yourself, you could be in real trouble.


The case of Niall McGrath

In March 1989, Niall McGrath incurred massive brain injuries as he allegedly fell down steps in a London pub.  Six operations and ten days later, a week before his 21st birthday, doctors pronounced him ‘clinically dead’.  Sandy, his sister, said, ‘They actually withdrew him off life-support three times.  He was a write-off.’  But instead of rapidly wasting away, Niall began to breathe.  He was moved to the National Rehabilitation Centre in Dun Laoghaire and later to St Joseph’s Care Home in Longford, Ireland, where he has remained ever since.


Up until 8 years ago, Niall could not speak or move.  Then in 2010 he stunned doctors when he came out of his coma.  He has since been steadily recovering.  Now the 50-year-old is making massive strides.  He is able to stand up for 25 minutes and he can transfer himself from the wheelchair to the bed.  He also uses an iPad, and attends speech therapy.  His sister calls on him every lunchtime and brings Niall’s 73-year-old mother, Mary, to visit him every evening.  Sandy is concerned that people like Niall could die under legislation passed by the UK’s Supreme Court in July allowing medical teams and families to withdraw life support without applying to the courts.  She fears similar laws may be introduced into Ireland.


Euthanasia numbers from Belgium

Every two years the Belgium Federal Commission on the Control and Evaluation of Euthanasia presents a report detailing statistics and developments in the practice of euthanasia in Belgium.  Here are some of the latest data, which relate mostly to a 12-month period between 2016 and 2017.


Deaths by legal euthanasia have increased nearly tenfold (982%) from 235 in 2003 – the first full year of legalisation – to 2,309 in 2017.  From 2016 to 2017 alone the increase was 13.8%.  Officially reported euthanasia accounted for 2.1% of all deaths in Belgium during 2017.  Organ donation couples with euthanasia (ODE) was reported in 8 patients – the majority of them were female, Dutch speakers, aged 50 to 69 and with their deaths imminently expected.


There were 375 cases of reported euthanasia of people whose deaths were not expected in the near future.  They represented 16.2% of all cases of reported euthanasia.  There were 181 cases of reported euthanasia for ‘polypathology’, where two or more conditions exist, but none of which is a sufficient ground for euthanasia this represents a 69.1% increase in just two years from 2015.  In 27 (7.2%) of these cases the mandatory one-month waiting period between the written request for euthanasia and its execution was not complied with, yet the Commission took no action on these cases other than sending the offending physician ‘a didactic letter to remind the doctor of the procedure to be followed in cases of unexpected death in the short term.’  A further 87 cases involved no physical suffering at all.  This included 14 people with cancer, 15 with physical illness, 18 of ‘polypathology’ and 40 of mental ill health.  There were also 3 children killed between 2016 and 2017.  These were a 17-year-old child, who was suffering from muscular dystrophy; a 9-year-old child, who had a brain tumour, and an 11-year-old child with cystic fibrosis.


What to conclude?  There is no doubt that euthanasia practice in Belgium is continuing on a dicey pathway of normalising the practice.  It has been 16 years of slippery slope.  It is becoming the go-to response to an ever-increasing range of circumstances, medical, physical and psychiatric, and including children.  Moreover, there is good evidence that the law is being repeatedly flouted and the authorities are turning a blind eye.


AAFP goes ‘neutral'

In early October, the American Academy of Family Physicians (AAFP), one of largest medical associations in the US, with over 131,000 members who specialise in family medicine, dropped its long-standing opposition to euthanasia.  Instead, it voted at the Academy’s 2018 Congress of Delegates in New Orleans to adopt a position of ‘engaged neutrality toward medical aid in dying as a personal end-of-life decision in the context of the physician-patient relationship.’  Whatever does that mean?  Over two-thirds of delegates voted to change the position.  Several representatives gave emotionally-charged speeches about how the availability of euthanasia could help ease the suffering of patients.


The new resolution passed by the delegates also calls on the AAFP to reject use of the phrases ‘assisted suicide’ or ‘physician-assisted suicide’ in its own formal communications and instead use the term ‘medical aid in dying’.  This is reminiscent of the term ‘medical assistance in dying’ (MAID) favoured in euthanasia-ridden Canada.  While some delegates were very disappointed by the decision, their consolation is that the AAFP did not endorse euthanasia, at least, not for the moment.


But is ‘neutrality’ a viable stance?  The American Medical Association (AMA), an umbrella organisation, of which the AAFP is one of dozens of medical associations, opposes ‘aid in dying’.  Its official position is that, ‘Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.’  Must the AAFP now quit the AMA?


Canada slips down the slope

Euthanasia enthusiasts are never satisfied.  Once they get the practice onto the Statute Book they always want to widen and deepen the eligibility criteria.  And so it has come to pass in Canada.  In 2015, the Supreme Court of Canada decided to decriminalise medical assistance in dying for patients who are experiencing ‘grievous and irremediable’ suffering.  The next year, the Canadian government passed legislation that permits doctors to hasten the death of a patient.  So why not couple one wish with another and combine euthanasia with organ donation?


This would be ‘a good thing’ according to an opinion piece by Ball, Sibbald and Truog in the New England Journal of Medicine (2018) 379: 909-911 and entitled, ‘Voluntary Euthanasia Implications for Organ Donation.’  These two physicians and a bioethicist state that, ‘Canada now permits physicians to hasten the death of a patient by means of physician-assisted suicide or voluntary euthanasia.’  And they go further, ‘This development creates a new pathway for organ donation.’


They believe that euthanasia offers significant advantages for organ transplant surgeons.  The normal organ donation protocol is to wait for a couple of minutes after blood circulation ceases in the dead donor.  But even in that brief space of time the quality of the organs declines.  If they were removed in a coordinated operation from a euthanasia patient, they would be as fresh as possible.  This macabre scenario is already practised in Belgium and the Netherlands as organ donation euthanasia (ODE).  The current authors recognise that the Canadian medical system would first need to be tweaked ICU staff would need training to keep people alive.  They would actually have to kill patients for their organs.  And conscientious objectors could pose an obstacle.  But hey, who cares about such niceties?  The entrée consists of a happy death and nice warm organs.  Who could possibly object?


Euthanasia in Australia

In August, Australia’s Senate voted down a Bill that would have allowed the country’s two territories the Australian Capital Territory (ACT) and the Northern Territory to legalise euthanasia.  The Senate narrowly rejected the Bill by 36 votes to 34 after several days of debate.  The Bill was sponsored by an independent, Senator David Leyonhjelm, and was widely supported by the Australian Labor Party senators and senators from smaller parties.  Most members of the government, however, opposed the legislation.


If successful, the Bill would have overturned the Euthanasia Laws Act 1997, a law that removed the power of the ACT and Northern Territory to legislate on euthanasia.  That law was introduced in response to the Northern Territory’s legalisation of euthanasia in 1995, but which was repealed the following year.  This latest development in the Australian euthanasia debate is particularly significant, as euthanasia legislation would likely have had strong support in both the ACT and Northern Territory.


Euthanasia in Spain

Las malas noticias!  Last year, a poll found that 84% of Spaniards supported euthanasia for people with incurable conditions.  Now Spain has taken a step towards becoming the first Roman Catholic country in southern Europe to legalise euthanasia by passing a draft law giving its citizens the right to die.  There is overwhelming support for decriminalising euthanasia and the legislation could make it available through public healthcare.  The Bill, proposed by the new Socialist administration, was backed by the centre-right Citizen’s party, Podemos on the far left, and regional parties from the Basque Country and Catalonia.  The conservative Popular Party (PP) opposed the Bill but it still passed by 208 votes to 133.


The proposal will now be debated before it returns for a final vote and could be law next year, making Spain the seventh country to legalise ending life.  The draft law stipulates that a person can choose to die if they have a serious and terminal illness, or a chronic and severe disability.  They must be Spanish or legally resident, meaning that British expatriates might also be eligible.  A request to die must be made in writing, without pressure, and repeated after 15 days.


Adriana Lastra, a Socialist MP, said that her party had modelled the Bill on legislation in Holland, Belgium and Luxembourg.  She said, ‘We present this law with respect for dignity [and] liberty and respect for people whose only possibility is to suffer; we want to put an end to this hell.  It is their last desire, their last right, their last freedom: to die well.  Pilar Cortés, a PP MP, responded, ‘To talk about euthanasia is to talk about failure, to admit a political, professional and medical defeat.’


USA and Elsewhere


Brett Michael Kavanaugh

So Donald Trump’s controversial nominee finally got his seat on the SCOTUS, the Supreme Court of the United States.  Justice Kavanaugh is a 53-year-old Roman Catholic, who is married to Ashley with whom he has two daughters.  On the evening of 6 October, he was sworn in at a private ceremony after weeks of acrimonious debate.  The Senate had earlier backed his nomination by 50 votes to 48.  All this followed four days of questioning by the Senate Judiciary Committee, a bitter battle over claims of sexual assault (which he vigorously denied), an additional investigation by the FBI, several excoriating articles in the media, and numerous protest marches by feminists and others.


Why all the bluster?  First, there were the assault claims that reached back to the 1980s.  Second, there was Mr Kavanaugh's record of previous legal opinions – he is considered to be conservative and therefore, because he is replacing the liberal Justice Anthony Kennedy, he will likely tilt the balance of the SCOTUS to 5 vs. 4 in opposition to issues like abortion and same-sex ‘marriage’.  Many consider that the colossus of Roe vs. Wade could now be under threat.  His appointment is for life and the US pro-life constituency is generally delighted, maybe even thrilled.


Donald Trump on evangelicals

In late August, a dinner was held at the White House attended by leading evangelical Christians.  Donald Trump recognised the support he had received from them to secure the presidency, ‘But I really don't feel guilty because I have given you a lot back, just about everything I promised.’  He pointed to moves by his administration to stem the flow of federal funding to abortion clinics and his work to secure the freedom of imprisoned church leaders around the world.


Mr Trump welcomed several high-profile Christian figures for the formal occasion, including Rev Franklin Graham, the president of the Christian university Liberty, Jerry Falwell Jr. and James Dobson from Focus on the Family.  The US President also said that ‘attacks’ on faith communities throughout the US were ‘over’, citing his efforts to protect freedom of conscience and religious liberty.  He added, ‘Unlike some before us, we are protecting your religious liberty.  We're standing for religious believers, because we know that faith and family, not government and bureaucracy, are the centre of American life.  And we know that freedom is a gift from our Creator.’


It is now said that there are more evangelical Christians in the Trump government than ever before.  And there are Bible studies in the White House, and there is more prayer in that building than since America’s early history.


Chelsea Clinton on abortion

The daughter of former US President Bill Clinton was interviewed by the satellite radio station, SiriusXM, in September.  She suggested that it would go against Christian values for the United States to revert to a time before Roe vs. Wade.  She talked about her efforts to keep abortion legal in the US and said, ‘Every day I make the moral choice to be optimistic that my efforts and my energies, particularly when I'm fortunate enough to be in partnership with fellow travellers, hopefully will make a difference.’  Asked about a possible repeal of Roe vs. Wade, she replied, ‘That's unconscionable to me, and also, I'm sure that this will unleash another wave of hate in my direction, but as a deeply religious person, it's also unchristian to me.’  OK, her views are ditzy, but she does have political ambitions and so her views are noteworthy (and worrying).


Foetal parts for sale

In July, the US Food and Drug Administration (FDA) had awarded a one-year contract to spend taxpayer’s money to buy aborted foetal parts for experiments to breed ‘humanized mice’ in order to evaluate the safety and efficacy of various drugs.  Advanced Bioscience Resources Inc. (ABR), a California-based company, would supply ‘fresh’ and ‘human fetal tissue’.  According to ABR such tissue is obtained from first or second trimester abortions, as well as full-term stillbirths.  ABR has previously admitted to Congress that it obtained tissue by collecting human foetal remains from abortion clinics, paying $60 per ‘single aborted fetus’ and then upselling the unborn child’s body parts separately to researchers for $325 per ‘specimen’ – brain, eyes, liver, thymus and lungs.


The pro-life lobby was outraged.  Marjorie Dannenfelser, president of the pro-life Susan B. Anthony List group, said, ‘Under no circumstances should the US government be contracting with baby-parts dealers like ABR – who have partnered with abortion giant Planned Parenthood – or taxpayers be forced to fund such atrocities.  We call on Congress to … stop taxpayer funding of these repugnant practices and act swiftly to ban them altogether.’


Meanwhile, the US Department of Health and Human Services (HHS), which oversees the FDA, had been reviewing ‘all research involving fetal tissue’ and ‘all acquisitions involving human fetal tissue.’  On 24 September, it cancelled this $15,900 contract with ABR.  According to the HHS it ‘was not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements.’  The government’s action comes after 85 members of the US House of Representatives sent a letter to the FDA on 17 September, saying that the purchasing of aborted fetal tissue for use in research is ‘abhorrent’ and must stop, and claiming that ABR might have violated federal law by selling ‘the body parts of children’ for a profit.


Some think that the Trump administration will introduce a ban or heavy restrictions on federally-funded experiments with fetal tissues.  Others think that if you’re going to throw away the aborted tissue anyway, can you not at least donate it to important medical research?


The world and euthanasia

During the first week of October, the World Medical Association (WMA) held its annual medical ethics conference and annual general meeting in Reykjavik.  Euthanasia was on the agenda.  The pro-euthanasia Canadian Medical Association (CMA) and the Dutch Medical Association (KNMG) prepared a resolution in a bid to change the position of the WMA’s opposition to euthanasia.  In the event, it was withdrawn because of lack of support.


Meanwhile, the August edition of the WMA's World Medical Journal contained reports from doctors around the world who had debated end-of-life care issues.  In Brazil, WMA members declared that, ‘if the doctor is prepared not only to cure but also to kill, the ethics of medical practice and the trust that the patient must have in his doctor will be very battered.’  Furthermore, all of the medical associations in Israel, Australia, New Zealand, Japan and China were opposed to euthanasia.  Similarly, those in Africa, were ‘unanimously opposed to euthanasia and physician-assisted suicide in any form.’  At one of the symposia of the WMA conference, the majority of participants rejected euthanasia ‘as being diametrically opposed to the ethical principles of medicine and expressed concern that they could lead to misuse or abuse.’


Abortion in South Korea

Abortion is illegal in South Korea except for cases of rape, incest, genetic disorders, or where the pregnancy would threaten a woman’s health.  Yet it is also commonplace with about 340,000 technically-illegal terminations performed annually.  In August, the government issued regulations that threatened to ban doctors from practice for a month if they were found to have performed an illegal abortion.  The new rules have included abortion among a list of ‘immoral medical actions’.

In September, almost two thousand South Korean obstetrics and gynaecology doctors protested against these new Ministry of Health and Welfare abortion regulations by refusing to perform abortions for women.  The Korean College of Obstetrics & Gynecologists issued a statement, ‘We flatly refuse to carry out abortions, which the government has defined as an immoral medical action.’  Lee Young-Kyu, vice-chairman of the Korean College of Obstetrics & Gynecologists, said that the ban was ‘simply appalling’.  ‘Patients, who seek abortions, were often poor or underage’, she said, adding that, ‘If women were forced to give birth in these circumstances, it puts a question mark on whether that is moral.’  Meanwhile, the country’s Constitutional Court is reviewing the near total ban on abortion, and is expected to make a ruling later this year.


Abortion in Argentina

Currently abortion in Argentina is allowed only in cases of rape, or if the mother's health is in danger.  In August, Argentina’s Senate rejected a Bill, which would have legalised abortion in the first 14 weeks of pregnancy, by 38 votes to 31.  After a marathon session that lasted 17 hours, senators voted against the Bill that had already been narrowly approved by the Lower House.  Argentine president Mauricio Macri confirmed that he would have signed the Bill if it was approved by the Senate, despite his personal misgivings.


Pro-life activists were jubilant at the outcome.  One said, ‘It's a joy to see that our society can be based on such an important principle as the defence of the most defenceless, the child.’  Camila Duro, from the pro-life organisation, Frente Joven, said, ‘The message that we wanted to put across is that abortion equals social failure.  For a woman to resort to it, many other things need to have failed first.’  ‘Abortion always kills a child and it doesn't solve the woman's problem.  We believe that this is never the solution.  Faced with an unexpected pregnancy abortion is never the solution.  There are always other solutions,’ said pro-life campaigner, Maria Castillo.  Nevertheless, pro-choice campaigners say they are not giving up.  Some started fires and lobbed missiles at police after the vote. 


IVF boost in China

China is in trouble.  The most populous country in the world is on a pathway to demographic disaster.  The population is aging and there are not enough babies being born to ensure a stable society.  By 2050, it is estimated that China will have 487 million people who are 60 or older, while the labour force will have shrunk to 424 million – last year it was 776 million.  The National Health and Family Planning Commission, China’s top health authority, is therefore considering a change in the law to encourage more women to have children.


For example, it may allow single women to access IVF programmes.  At present, any woman seeking fertility treatments in China must first produce a marriage licence, so single women have no choice but to go abroad to freeze their eggs or have IVF or sperm donation.  Li Jun, a Shanghai-based lawyer, has objected, ‘When you demand a woman to get married before she can have a child, that’s curbing one’s human rights.’  It is clear that Chinese women are choosing career over children.  So, for example, Ctrip, China’s largest travel agency, is offering its female employees, those in middle to senior management roles, from 100,000 yuan to 2 million yuan (£11,000 to £230,000) to spend on freezing their ova.  It is a scheme that Ctrip executives hope will enable women to stay in employment and to postpone having children for a little longer.  While it may be in the spirit of the government’s drive, it also has a practical advantage for the company.


In 2016, China loosened its notorious one-child policy, but, so far, there have been too few couples prepared to have extra children to make any real difference – the one-child family appears to have become a stubborn societal norm.




A shorter story

One of my favourite quotations is that attributed to Blaise Pascal, ‘Je n'ai fait celle-ci plus longue que parce que je n'ai pas eu le loisir de la faire plus courte.’  It translates as, ‘I would have written a shorter letter, but I did not have the time.’  It is recorded as number 16 of his ‘Provincial Letters’ written by Pascal to a group of Jesuits on 4 December 1656 protesting about the practical morals of the Roman Catholic Church.


Then again, I have heard [far too many] sermons that could have been cut, even slashed, without detriment.  Moreover, every piece of writing can be improved by editing, despite the usual protestations of prolix authors.  More’s the pity that a growing number of publishers no longer employ copy editors with their blue pens and scissors.  And by editing is invariably meant shortening.  So, how about not just shortening an article, but going for the ultimate and creating an entire story in just a few, say, six words?  In the truncated world of Twitter that ought to be simple.


But can this fabled example, often ascribed to Ernest Hemingway, which he produced allegedly to win a bet, be improved upon?  Here it is: For sale, Baby shoes, Never worn.  Beat that!  See, there is already a story going through your head, perhaps even the rough outline of a film.  And does it have a definite bioethical theme?  It does for me.


Are you fat and lonely?

Thankfully, currently, I am neither, but I know people who are.  About 62% of adults in the UK are now classified as overweight, while 28% are clinically obese.  Obesity is one of the leading preventable cause of death.  It is often associated with additional conditions, like diabetes mellitus, heart disease and stroke.  The NHS is already creaking with the obesity overload.  Most of its victims simply eat too much, especially the wrong types of food, and they typically lack sufficient physical activity.

Similarly, loneliness is on the increase.  Over 9 million people in the UK – almost a fifth of the population – say they are always or often lonely.  At least half (51%) of all people aged 75 and over live alone.  Two fifths of all older people, almost 4 million in total, say the television is their main company.  Prime minister, Theresa May, has recently announced a range of activities that GPs can refer their lonely patients to, as a means of tackling this epidemic.  These will include social activities, such as cookery classes, walking clubs and art groups.


Both obesity and loneliness are sad and dangerous markers of our so-called advanced Western society.  We can all think of simple reasons why some are fat, or lonely, or both.  But is there a genetic reason?  Do genes predispose some people to these conditions?  It might seem a theory a tad farfetched, but it has been the subject of a recent study published in Nature Communications (2018, 9: 2457) by Day et al., from the University of Cambridge School of Clinical Medicine, under the title, ‘Elucidating the genetic basis of social interaction and isolation.’  They kindly reframe fat and lonely as ‘adiposity’ and ‘social isolation’.


The researchers performed genome-wide association study analyses for loneliness and regular participation in social activities in 452,302 UK Biobank study participants.  They identified 15 genomic loci for loneliness, and demonstrated a likely causal association between adiposity and increased susceptibility to loneliness and depressive symptoms.  Fascinatingly, further loci were identified for regular attendance at three places – a sports club or gym, pub or social club, or religious group.  They found, ‘Across these traits there was strong enrichment for genes expressed in brain regions that control emotional expression and behaviour.’


And furthermore, ‘These data highlight shared genetic architecture between loneliness and a range of complex traits, including a causal relationship between body size and loneliness/depressive symptoms.’  In other words, some people are genetically prone to an association between ‘adiposity’ and ‘social isolation’, but only a little, just 4.2%, so don’t blame your genes for your troubles.  And the remedial prescription?  Eat less, walk more, and go to church would be a good start for many.


What is full and valid consent?

Depending on the context, consent to treatment can be varied.  When I go to the doctors’ surgery with my painful, swollen ankle and she says, ‘May I have a look?  It would be churlish of me to refuse.  Typically, taking off my sock is deemed to be my consent.  Moreover, ‘a look’ is customary code for, ‘May I touch, prod and gently twist it?’  There is no discussion, no paperwork, no signature involved.  On the other hand, when I go to hospital to have surgery on that ankle, there is discussion, paperwork and signature.


Doctors are supposed to treat patients with respect, which implies engaging with them, giving them enough time and encouragement to ask questions, such as, ’What if I do not undergo this operation?, what are the side-effects of this medicine?, is there another, better option?, and so on.  Getting answers to these sorts of questions undergirds what that man on the Clapham omnibus would consider to be the best route to full, valid and informed consent.


In the UK, until recently, such consent was based on the Bolam test, namely, whether a reasonable body of medical opinion would agree that a professional’s duty of care had been fulfilled.  Then along came Nadine Montgomery.  She gave birth to a baby boy on 1 October 1999 at Bellshill Maternity Hospital, Lanarkshire.  The birth was complicated by shoulder dystocia that resulted in the child being born with cerebral palsy.  A case of medical negligence was pursued as Montgomery vs. Lanarkshire Health Board.  In those proceedings, Mrs Montgomery sought damages on behalf of her son for the injuries which he sustained.  She attributed those injuries to negligence on the part of Dr Dina McLellan, a consultant obstetrician and gynaecologist, who was responsible for Mrs Montgomery’s care during her pregnancy, labour and delivery.


Eventually, in 2015, the UK Supreme Court declared that the Bolam test was an outdated instance of medical paternalism.  The Montgomery ruling established that doctors must ensure that their patients are aware of any material risks involved in a proposed treatment, and of reasonable alternatives.


This is particularly relevant in cases of abortion.  Is the women presented with ‘reasonable alternatives’?  Is she told about the possibilities that the procedure may be linked to the onset of breast cancer, physical and mental health issues, fertility loss, and so on?  These may be controversial sequelae, but is the women entitled to hear them before she gives her full and valid consent?  After all, she is about to decide to let a doctor take the life of her unborn child.  That is no small decision.


So, three years on, how is the Montgomery ruling working?  The unadorned answer from an article in the Lancet (2018, 392: 102-104) and entitled, ‘How Montgomery is reconfiguring consent in the UK’ by Natalie Harrison and colleagues from London, is ‘slow and patchy’.  They carried out semi-structured interviews with six obstetric consultants and doctors and four barristers, all practising in the UK.  They reported that, ‘The Montgomery ruling aimed to guide the medical profession towards a new model of shared decision making, however, doctors are still working out what the ruling means in practice.’  The authors provide a number of innovative attempts being implemented here and there, but there seems to be little professional assistance.  For example, only two of the 24 member colleges of the Academy of Medical Royal Colleges (the Royal College of Obstetricians and Gynaecologists and the Royal College of Surgeons of England) have issued detailed guidance in light of the ruling.


John Craig Venter

I like to include a human-interest piece in these Updates on Life Issues, whether as an obituary or as a biographical piece.  It is not my fault that no-one worthy of a valedictory article has died recently.  Instead, let us look at Craig Venter, the 72-year-old, variously described as ‘one of the leading scientists of the 21st century for his numerous invaluable contributions to genomic research’, ‘a maverick American biologist’ and ‘not a man to balk at breaking a few eggs to make a scientific omelette’.


From 1967 to 1968, John Craig Venter was on duty as a Navy Corpsman in Vietnam.  He then earned a bachelor’s degree in biochemistry and a PhD in physiology and pharmacology from the University of California at San Diego.  Next, he was appointed professor at the State University of New York at Buffalo and the Roswell Park Cancer Institute.  After time working at the US National Institutes of Health, he founded The Institute for Genomic Research, where, in 1995, he and his team decoded the genome of the first free-living organism, the bacterium Haemophilus influenzae, using his novel whole genome shotgun technique.  In 1998, Venter founded Celera Genomics to sequence the human genome.


He is best known for challenging the scientific Establishment in that race to decipher the human genome, a task completed in 2000.  With his shotgun sequencing technique, he achieved in two years what the official Human Genome Project (HGP) had taken 14 years to complete.  Since then he has attempted to patent artificial microbes, to reconstruct people’s faces from their DNA and to comb mankind’s genetic library in search of the secret of longevity.  He is the author of more than 280 research articles and two books, including an autobiography (of course).  Oh yes, he is a real, scientific superstar.


Now Craig Venter is embroiled in perhaps his biggest wrangle.  Human Longevity, Inc. (HLI), is a company he set up with two colleagues in 2013 to search the growing masses of genetic data in the hope of generating treatments for diseases associated with ageing – he believes he can help people live to 100 and beyond.  Last July, HLI began suing his San Diego-based, non-profit organisation, the J Craig Venter Institute, over allegations that he stole its trade secrets, poached its staff, and sought to lure away its investors.  It takes a special sort of man to generate that sort of predicament.


A spokeswoman for HLI said, that as yet, the company could not offer any further clarification because that would involve describing its ‘litigation strategy’.  ‘We do not comment on such matters while litigation is pending,’ she said.  Meanwhile, the J Craig Venter Institute dismissed the claims as, ‘baseless, without merit and [marred by] numerous factual errors.’  And, ‘We intend to vigorously defend against these allegations as the legal process advances.’  The document lodged with the Southern District of California court leaves space for an unspecified number of unknown ‘competitors of HLI’ to be added to the list of defendants.  The courts and J Craig Venter could be busy for many months to come.


A new Hippocratic Oath

It was a combination of the Hippocratic Oath and the Judeo-Christian doctrines that established the wholesome ethics and practice of early Western medicine.  With their ‘first, do no harm’ and ‘love your neighbour as yourself’, they kept medicine safe and beneficial for over 2,000 years.  Sadly, their influence has now declined.  The Hippocratic Oath has over the last 70 or so years reappeared in various, but always in bioethically-weakened, forms.


Here is a snapshot of that downgrade.  The original Hippocratic Oath specifically forbade both euthanasia and abortion, ‘I will give no deadly drug to any, though it be asked of me, nor will I counsel such, and especially I will not aid a woman to procure abortion.’  In 1947, the British Medical Association (BMA) affirmed that the Hippocratic Oath, '… enjoins … the duty of caring, the greatest crime being co-operation in the destruction of life by murder, suicide and abortion.'  By 1997, that same BMA had produced its draft revision of the Hippocratic Oath, which stated, ‘I recognize the special value of human life but I also know that the prolongation of human life is not the only aim of health care.  Where abortion is permitted, I agree that it should take place only within an ethical and legal framework.’  Similarly, in 2005, the World Medical Association approved a revision of the Declaration of Geneva, which modestly asserted, 'I will maintain the utmost respect for human life; I will not use my medical knowledge contrary to the laws of humanity, even under threat.’  The removal of that vital phrase ‘from the time of conception’ not only eliminated the implicit anti-abortion stance of the original, but it also simultaneously introduced doubt about the fundamental issue of when human life begins.


The University of Exeter Medical School was set up in 2012.  Its first-year students began the new programme in September 2013.  This summer, its first cohort of medical students graduated.  Interestingly, they devised their own version of the ancient Greek oath, which the 88 doctors-to-be swore at their July graduation ceremony.  It emphasised their commitment to service and care, advancing knowledge and life-long learning and teaching, and to maintaining their own health and well-being.


Amidst some of the somewhat florid language and politically-correct platitudes there was this welcome sentence, ‘I shall never intentionally cause overall harm to my patients, and will have the utmost respect for human life.’  While this echoes the grand Hippocratic statement, an echo is never as strong as the original chime it can be almost inaudible.  And the Exeter Oath also included, ‘I will work towards a fairer distribution of health resources and oppose policies in breach of human rights.’  One can only wonder if the Exeter doctors had ever pondered the 1948 General Assembly of the United Nations adoption of the Universal Declaration of Human Rights, of which Article 3 declares, 'Everyone had the right to life …'  Let us hope that these new doctors take seriously their pledge, ‘I will seek to increase my understanding and skills, and promote the advancement of medicine as both a teacher and a learner.’  May they read a good bioethics book!


Learn a new word

Tokophobia.  No, it’s not a fear of clocks – that is chronomentrophobia.  Tokophobia is a pathological fear of childbirth from the Greek tokos, meaning childbirth and phobos, meaning fear.  And it is apparently on the increase, according to Catriona Jones, a lecturer in midwifery at the University of Hull.  So much so, that NHS perinatal mental health services have asked her to look into the problem after a recent and notable rise in the number of women asking for caesarean sections.  For some women tokophobia can be so severe that they never become pregnant or, if they do, they may decide to abort.  What such women need is a pathway of proper support and care, which should be available from mental health practitioners, midwives and health visitors.  Or they could spend time with a pro-life counsellor.


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