Update on Life Issues - February 2022

Abortion global statistics
Consider this: during 2021, more human beings died by abortion than any other cause of death.  Statistics compiled by Worldometers indicate that there were over 42.6 million abortions worldwide last year.  This independent organisation collects data from governments and other sources and then reports the figures, along with estimates and projections.  It estimated that the overall global abortion figure was this huge 42,640,209.

By contrast, 8.7 million people died from cancer in 2021, 5 million from smoking, 13 million from various other diseases and 1.7 million from HIV/AIDS.  With 58.7 million people dying during 2021 from a cause other than abortion, means that abortions accounted for 42% of every death around the world.

Of course the accuracy of these data can be questioned.  Many are true, some are guesstimates, while others are probably dubious.  But what is not in doubt is the overall trend.  In any table of 2021 deaths, abortion will come top.  Even compared with the 5.5 million Covid-19 deaths since the pandemic started two years ago in 2020, abortion is the big killer.

Abortion in the USA
The two BIG challenges to abortion in the USA, and by repercussion also to abortion worldwide, are still bound up in the forthcoming US legal case emanating from Mississippi of Dobbs v. Jackson Women’s Health Organization and its ban on abortions after fifteen weeks, plus the contentious 2021 Texas Heartbeat Act and its ban on abortions after six weeks.

First, after several complex rulings in lower courts, Dobbs v. Jackson Women’s Health Organization has eventually arrived at the Supreme Court of the United States (SCOTUS).  Oral arguments were heard on 1 December 2021 – judgement is expected by the Summer of 2022, perhaps in June.  In other words, a decision is pending.  Pro-life advocates hope, even expect, the SCOTUS will overturn or, at least, scale back Roe v. Wade and again allow individual states to protect their unborn children.

Second, the 2021 Texas Heartbeat Act has also been subject to numerous legal disputes aimed at overturning this law.  On 22 October, the SCOTUS agreed to review two challenges – one brought by the US Department of Justice and the other by an abortion provider.  The cases were argued on 1 November.  The SCOTUS rejected the former case and voted to remand the other case back to the Fifth Circuit.  On 9 December, a district court judge, David Peebles, ruled that portions of the Act violate the Texas Constitution, but he did not insist on enforcing the law.  That ruling was appealed.  On 20 January, the SCOTUS voted 6 to 3 to reject a plea to return the case to US District Judge Robert L Pitman, who, in October, had issued a ruling blocking the Texas ban.  In other words, the Texas Heartbeat Act remains in force – it is estimated that it has already save the lives of as many as 10,000 unborn children.

Meanwhile, Americans have been surveyed.  In a Marist poll, published in January, respondents self-identified as 55% ‘pro-choice’ and 40% as ‘pro-life, yet 61% want Roe v. Wade overturned.  Only 17% agreed that, ‘abortion should be available to a woman any time she wants one during her entire pregnancy.’  In other words, 83% of US citizens want some kind of limitation on the current US pro-abortion legal policies.

DIY abortion dangers
Chemically-induced abortions, also known as medical abortions, involve taking two tablets.  The first, mifepristone, is taken at a hospital or clinic.  It is designed to kill the developing baby. The second, misoprostol, can usually be taken at home where it induces a miscarriage to expel the unborn child from the womb.  In the UK, 85% of all abortions are now medically induced.

From March 2020, in response to restrictions imposed because of the Covid-19 pandemic, the government introduced telemedicine and ‘emergency’ measures to allow both abortion pills to be taken at home, with no direct medical oversight.  In other words, medical abortions became DIY abortions.  These measures were regarded as stopgap.

Kevin Duffy, an independent public health consultant and former director of abortion at Marie Stopes International, has led a freedom of information (FOI) investigation into what the government promised would be a temporary change to the medical abortion rules.  The report is available online under the title, FOI Investigation into Medical Abortion Treatment Failure.

Duffy and his team garnered responses from 85 NHS Trusts in England, representing about an 80% coverage of the population.  He discovered that between June 2019 and May 2021 at least 10,000 women, or about 6% of abortion pill users, had reportedly needed to attend hospital suffering from serious side effects.  More than half of these women required surgical intervention, mainly for retained products of conception (RPOC), and over a third needed medical help because of severe haemorrhaging.

Duffy has said, ‘This is the disturbing truth of abortion care during the pandemic that has not been reported to the government by providers.  This investigation exposes the reality of what thousands of women experiencing crisis pregnancies have been through during the pandemic.  It demonstrates clearly what needs to change and why the government must not make DIY home abortion telemedicine permanent.  The time to end it is now well overdue.’

In November 2020, the government launched a public consultation entitled, Home use of both pills for early medical abortion, on whether to make these new rules permanent.  The closing date was 26 February 2021 but the government has yet to declare its policy intentions.  The GOV.UK website merely states, ‘We are analysing your feedback.’  Could it be that the government wants the ‘emergency’ measures made permanent?  Probably.  But on the basis of the results from Kevin Duffy’s investigations, the government should decide and act, pronto.

Abortion as a perk
All sorts of jobs have all sorts of perks.  Of course there are wages and holidays and protective clothing and some companies will even pay for IVF treatments.  Step up the City of Boston, Massachusetts.  Its employees can now apply for up to 12 weeks of paid leave after an abortion.

This is quite the opposite of the traditional maternity leave, which has also morphed, in an age of equality, into paternity leave.  The Boston perk, approved at a City Council meeting last September, applies to both women and men.  How woke!  But hey, men can also be profoundly affected by abortion.  Allowing time to bond with baby and the physical and emotional disruptions the little tot brings is a sensible and practical perk.  But post-abortion?  With no baby?  Perhaps abortion is not just that quick lunchtime op as it has been advertised.  Perhaps it really does adversely affect both women and men so that they need time to recuperate.

As Patricia Stewart, of Massachusetts Citizens for Life, commented in The New Boston Post the move supports the pro-life argument, ‘Ironically, the grant of abortion leave reinforces the pro-life view that abortion is a serious medical choice with potentially life-altering consequences for a woman’s physical, emotional, and psychological health.’  Maybe Boston really is the ‘Cradle of Modern America’.

Abortion bill in Northern Ireland
Like the rest of the UK, abortion in Northern Ireland is legal up to birth if a serious handicap is suspected, not necessarily proved.  Such conditions would include Down’s syndrome, spina bifida and cleft palate.  Disability campaigners have long recognised the inequality of such a measure and therefore supported Paul Givan as he sponsored and introduced the Severe Foetal Impairment Abortion (Amendment) Bill on 16 February 2021.  It would have prevented abortion up to birth for babies with non-fatal disabilities.  There were high hopes of legislative success.

But those hopes were dashed on 14 December, when Members of the Legislative Assembly (MLAs) voted by 45 to 42 to reject a key clause in the Bill at its Consideration Stage.

Supporters of the Bill were aghast.  The Moderator of the Presbyterian Church in Ireland (PCI), the Right Reverend Dr David Bruce, expressed the dismay of many at the Bill's defeat.  He stated, ‘We are deeply disappointed that this legislation was rejected by a very narrow majority of MLAs.  The decision by MLAs sends a profound message to society about the value that is placed on all human life.  Within PCI we affirm that all human life has value and dignity, because of our belief that we are all made in the image of God.  We believe that our worth and identify derives from this principle, rather than a subjective judgement about quality of life, and the ability to make a contribution to wider society.’

Lynn Murray, from the disability rights' charity Don't Screen Us Out and the mother of a daughter with Down's syndrome, said, ‘There's been very overwhelming public support for this law to change and almost 100% of the submissions to the Northern Ireland Committee for Health Consultation on the Bill supported this important law change.  Any law that should be brought about now should consider the fact that a life of disability is as equal to any other life, and we should not discriminate against it in any law.’

Opponents of the Bill and pro-choice campaigners have argued that the Bill was an attempt to erode women's reproductive rights.  Oh, my heart sinks.

IVF and ARTs
Changes to fertility law and practice
There is always, quite rightly, considerable nervousness in the air when the HFEA (Human Fertilisation and Embryology Authority) begins to publicise its plans to tinker with the 1990 Human Fertilisation and Embryology Act, the law that governs human embryo research and fertility treatments in the UK.  Such occasions usually presage a loosening of the current legal and bioethical boundaries.

And so it was on 1 December 2021, at the annual conference of the Progress Educational Trust (PET), with its stated ‘mission is to educate and debate the responsible application of reproductive and genetic science.’  In other words, it wants to liberalise most aspects of the 1990 HFEA Act.

Top of the list of the twenty or so speakers was Julia Chain, since April 2021, the chairwoman of the HFEA.  She is a qualified corporate lawyer and active in the charitable and public sector, especially with Jewish organisations.  There is some hope that she can sort out the problems at the HFEA in terms of its unbridled procedures and lack of conservative bioethical practices.

During her PET speech, Mrs Chain clarified her view that much of the 1990 HFEA Act remains suitable for purpose.  Phew, so no wholesale revision is envisaged.  However, she claimed that the fertility and research sectors had become increasingly difficult to regulate, given the substantial medical advances and changes in social attitudes.  So is the 1990 Act suitable, or is it creaking a little?

Prior to her speech Mrs Chain had asserted, 'It's time we really had a look at what needs to be modernised.'  In her address, she pointed out that the 1990 Act does not contain ‘any words in it relating to patients, patient safety, or even outcomes of treatment.’  As a regulator, she argued that it was the duty of the HFEA 'to keep all those three things at the front of our work.’  OK-ish, so far.

Nevertheless, there seems to be some friction between PET and the HFEA.  Another speaker, Sarah Norcross, director of PET, welcomed the HFEA’s call for modest modernisation.  She continued, somewhat provocatively, that, ‘The law and regulation that govern fertility treatment and related research are showing their age.’  Hers was clearly a call for more fundamental changes to the 1990 Act.

Chain continued in her speech, by highlighting several other areas of the 1990 Act that require attention.  The first concerned patients’ protection and maintaining the quality of care provided for them.  This would address poor performance, such as economic sanctions against non-compliant fertility clinics.  This would also include addressing the increasing commercialisation of the fertility sector, where 65% of treatments are self-funded and public funding is poorly distributed, resulting in the infamous 'postcode lottery'.  However, she explained that the HFEA currently has little power over this particular aspect of fertility treatment.

Chain also tackled the issue of fertility treatment 'add-ons', and the long-known possibility that these can contribute to patient confusion and to financial exploitation by clinics.  In addition, she touched on several other areas where she considered the 1990 Act to be out of step with modern families and medicine, including the definition of a mother as 'the woman who is carrying or has carried a child'.  This, she explained, effectively excludes some same-sex couples, transgender parents and single parents.

Finally, Mrs Chain singled out the 14-day rule, which currently requires human embryos used in research to be destroyed within 14 days of their creation.  This is a present-day hot potato with research scientists increasing calling for an extension of this upper time limit.

Somewhat regretfully, Chain anticipated that quick progress could be made to bring about some of these controversial changes, saying that, 'We are not starting with a blank sheet of paper and much of the Act remains fit for purpose.’  She added that her aim is 'to reach an outline agreement with the Department of Health and Social Care next year on what needs to change.'  This speech was a curate’s egg lecture – good and bad in parts.  The good bits are to leave the 1990 Act intact despite its utilitarian agenda and anti-life stance.  It could be made worse.  The bad bits are the push for ever more fertility treatments and lengthier research – in other words, more deliberate destruction of human embryos.

Well, whatever next?
When are genes first active in newly-formed human embryos?  A good question to which all worthy pro-life people will intuitively reply, ‘On day one, of course.’  And they are right, both bioethically and scientifically, but it is only recently that some scientists are catching up on the correct science.

A recent study has shown that human embryos begin to display gene expression [the process whereby the information contained in a gene is converted into a gene product, usually a protein] at the single-cell stage, during day one, immediately after fertilisation has commenced, and called a zygote.  Well, whatever next?  So what have pro-life people been maintaining for decades?  Explicitly and exactly that.  It is the way the zygote divides and grows into the next essential stage of human development, the morula and then the blastocyst and so on.  Apparently, previous studies could not detect genetic transcription, [the process whereby DNA is read, messenger RNA molecules produced and proteins synthesised] until the embryo had grown to four or eight cells, around two or three days after fertilisation.  So when does human life begin?  Come on you casuists and sophists and doubters, speak up.

A team of scientists, co-led by Professor Tony Perry at the University of Cambridge and Dr Matthew VerMilyea from Ovation Fertility in the USA, used high-resolution single-cell RNA-sequencing methods to measure genetic transcription in 12 human ova donated by seven women and 12 human embryos provided by six different donors.  The work, entitled, ‘Human embryonic genome activation initiates at the one-cell stage’, by Maki Asami et al., has been published in Cell Stem Cell (2022, 29: 1-8).

Interestingly, the researchers found that gene expression continued from the single-cell embryo until the two, four and eight-cell stages when activity substantially diminished.  Perry suggested that ‘a sort of genetic shift-work starts soon after fertilisation’ and a second shift takes over by the eight-cell stage.  Or, of course, this observed diminution of gene expression could have been due to an experimental artefact.

Bioethically, the results of this work are ‘old hat’.  Scientifically, it is somewhat novel.  It may lead to, for example, a better understanding of what triggers the activation of transcription, another poorly-understood process, thought perhaps to be triggered by the ovum.  There are many details around the early days of human life that are unknown and even baffling, but the basic foundations are clear.  As Asami and colleagues have confirmed, ‘Gene expression initiates at the one-cell stage in human embryos.’

Another bizarre case
From time to time the most uncanny examples of assisted reproductive technologies (ARTs) come to light.  Here is another.  Carole Horlock is probably the UK’s, maybe even among the world’s, most prolific surrogate mother.  She has carried 13 babies for others and then given them away.  Ten years ago, at the age of 49, she decided to stop surrogacy.

But there is more.  In June 2021, she confirmed that in June 2004 she inadvertently gave away one of her own children – born as a 9lb 4oz boy.  She believed he was conceived using her own ovum and the sperm of a client.  But some six weeks after the birth, the commissioning couple undertook DNA testing and discovered that the baby was hers and her husband’s, Paul.  However, they still chose to hand over their son.

As Mrs Horlock stated, ‘We agonised over what to do, but in the end decided to let them keep him.’  In the meantime, contact and communication with the commissioning parents and their son had broken down.  It is a recurring story.  As she confirmed, ‘But there is a darker side when it goes wrong – the heartbreak, emotional roller-coaster and acrimony are devastating.’  And yet, ‘We live in hope he is aware of us and, when he turns 18, (in June 2022) he’d like to see us.’ 

Is surrogacy good?  See how ARTs can wreck the wholesome, tried-and-tested patterns of traditional reproduction and parenthood?

ART adverse birth outcomes
There has been a plethora of studies examining pregnancies, births and outcomes associated with assisted reproductive technologies (ARTs).  Here is the latest to join that oeuvre.  It is entitled, ‘Medically Assisted Reproduction Treatment Types and Birth Outcomes: A Between-Family and Within-Family Analysis’ by Alina Pelikh et al., and published in Obstetrics & Gynecology, (2022, 139: 211

The authors’ objective was to compare the risks of adverse birth outcomes among pregnancies conceived with and without medically-assisted reproduction treatments.  They used the birth certificates of all babies born in Utah between 2009 and 2017 – a total of 469,919 deliveries of which 248,013 were studied further and of which 5.2% were conceived through ARTs, subdivided into ‘minor’ forms, such as fertility-enhancing drugs and ‘major’ forms, such as artificial insemination (AI) and in vitro fertilisation (IVF).

Those babies conceived through ARTs had lower birth weights (LBW), were smaller for gestational age (SGA) and more likely to be preterm (less than 37 weeks) than those neonates who were conceived naturally.  When the cohort who had used more invasive methods of ARTs, such as AI and IVF were studied, the outcomes were worse.  For example, the proportion of LBW and preterm birth was 6.1% and 7.9% among neonates conceived naturally and 25.5% and 29.8% among neonates conceived through ARTs, respectively.

After statistical allowances were made for various neonatal and parental characteristics, the differences in birth outcomes were less but still statistically significant.  For instance; ART-neonates were at 3.2% higher risk for LBW and 4.8% higher risk for preterm birth.  Unsurprisingly, when within-family analyses were made, that is among siblings, the differences in the frequency of adverse outcomes between natural and ART-conceived babies were small and statistically insignificant for all types of treatments.

Alina Pelikh and her colleagues concluded that, ‘Medically assisted reproduction treatments are associated with adverse birth outcomes; however, those risks are unlikely to be associated with the infertility treatment itself.’  Overall, this research adds little to what is already known.  Yes, babies conceived by ARTs, and especially IVF, display more and greater adverse outcomes than their naturally-conceived counterparts. And different studies report different figures for adversity.  And many other studies have concluded that the physical and chemical manipulation of ARTs, as well as the health problems of infertile couples, are likely causes of adverse outcomes.  This current study assessed none of these directly or in detail, only by deduction.

ARTs are always problematic.  And that applies not just to their bioethical dilemmas.  Or their costs.  Or their failures.  Or their stresses.  But also to their adverse outcomes.  Yes, again, ARTs are best avoided.

Euthanasia and Assisted Suicide
Baroness Meacher’s Bill
This Assisted Dying Bill is still awaiting its day in the Committee Stage, where Peers will discuss and vote on amendments to the Bill.  However, opponents have added nearly 200 amendments, many intended merely to frustrate the process and essentially to ensure the Bill will run out of time before it can proceed in the Parliamentary process.  It is another waiting game.

The UK is slipping
The UK’s Crown Prosecution Service (CPS) seems intent on moderating the rules governing the prosecution of those involved in so-called ‘mercy killing’ and suicide pact cases.  The upshot is that they will be less likely to face criminal charges.  A 12-week public consultation on new draft guidance, entitled, Consultation on public interest guidance for suicide pact and "mercy killing" type cases' and consisting of nine questions, was launched in mid-January and will run until 8 April 2022.

Current guidance states that, where there is enough evidence, ‘a prosecution is almost certainly required, even in cases such as the “mercy killing” of a sick relative.’  ‘Mercy killing’ is usually, and rather vaguely, defined as the killing of someone who is very old or infirm.  Under the new draft guidance in cases where a suspect is ‘wholly motivated by compassion’ or where the person had reached a ‘voluntary, settled and informed decision to end their life’, CPS prosecutors will be told that such cases may not be in the public interest.  Such changes would also apply to cases when someone has tried to take their own life as part of a suicide pact.  The Director of Public Prosecutions, Max Hill, has said that in certain cases, sometimes ‘justice can be achieved by not prosecuting.’

There are enormous dangers by introducing changes in this sensitive and emotive area.  As it stands, the law acts as both protective and deterrent.  Any liberalising changes and the vulnerable are most likely to be at heightened risk.  Senior prosecutors insist that the proposed guidance ‘specifically states that it is not intended to decriminalise murder, manslaughter or attempted murder.’  However, to many observers these proposals look as though ‘mercy killing’ is being gradually legalised.

England, Wales, Scotland and Jersey are on thin ice
On Wednesday 26 May 2021, Baroness Meacher introduced her Assisted Dying Bill in the House of Lords.  It aims to change the law in England and Wales to legalise assisted suicide for terminally-ill patients who have six months or less to live.  On 22 October, at its Second Reading debate, the Bill, as is convention, was passed unopposed.  As mentioned above, it now moves to the Committee Stage which is a line by line scrutiny of the proposals.  No timetable or publications have yet been forthcoming.

Meanwhile in Scotland, Liam McArthur MSP, of the Scottish Liberal Democrats, is sponsoring his Proposed Assisted Dying for Terminally Ill Adults (Scotland) Bill.  This is a proposal, an unusual procedural route, for a Member's Bill to enable competent adults, who are terminally ill, to be provided at their request with lethal drugs to end their life.  It has been strongly criticised by healthcare staff, academics, disability campaigners and faith groups.  These groups believe it will lead to serious harms against the most vulnerable, undermine palliative care, and create an ever-widening law.  They also stress that the process of assisted suicide itself is both painful and undignified.

The draft proposal was subject to a public consultation that closed on 22 December 2021.  An unprecedented in excess of 10,000 responses were received – the most replies to a member's consultation ever recorded at Holyrood.

A spokesman for CARE commented, ‘The huge response to this consultation underlines just how alarming and controversial Liam McArthur's proposals are in Scotland and more widely.  Many people are deeply upset at the prospect of legislation that would see suicide normalised in healthcare, with all the resultant harms for patients, medics and wider society.’

‘Good societies treat suicide as a terrible act, to be mourned and prevented.  We want to see a Scotland where hope and help are at the centre of our response to human suffering, not lethal drugs.  And we want to see excellent end-of-life care for every person.  When assisted suicide is legalised, this goal is undermined.  We call on MSPs in every party to carefully review the evidence of assisted suicide's harms and reject this latest attempt to change the law, as parliament has done on more than one occasion in the past.’

No further information, such as procedural timetables or the various parties’ policies, has been issued.

And the politicians of that tiny UK Crown Dependency in the English Channel, known as the Bailiwick of Jersey, have voted to approve in principle the legalisation of assisted dying.  They voted on 25 November by 36 in favour to 10 against with 3 absentees.  A further debate is to be held in 2022, after details of the processes and safeguards have been presented.  A draft law could be debated and voted on in 2023.

Austria capitulates
On New Year’s Day assisted suicide became legal in Austria.  The Austrian Supreme Court had declared that the country’s former ban was unconstitutional – apparently it violated a citizen’s right to self-determination.

The substance of the new law is fairly conventional.  A patient must be over 18 and chronically or terminally ill.  Each case is to be assessed by two doctors, one of whom must be an expert in palliative medicine.  There is a mandatory 12-week ‘cooling-off’ period, but if the patient is terminally-ill, that period can be reduced to two weeks.  The patient would then draw up an advance directive, or ‘death will’ with a lawyer or a patient advocate before being able to obtain a lethal drug from a pharmacist.

Until now, under Austrian law, anyone who assisted someone to kill themselves faced up to five years in prison.  However, and this is the unconventional bit, within the proposed regulations is an important rider.  The advance directive can specify a person who is authorised to assist the patient to end her life by helping her ingest the prescribed lethal drug.  This ‘assistance’ includes actively administering it, even if the patient loses decision-making capacity.  In other words, Austria has become the first jurisdiction to legalise euthanasia by lay persons, namely non-healthcare practitioners and family members.  Such assisting in the death of a person who is unable to self-administer the lethal poison is full-on euthanasia.

Assisted suicide and euthanasia are spreading across Europe.  The countries where one or the other or both are currently legal include Belgium, Luxembourg, the Netherlands, Switzerland and Spain.  Germany and Portugal have also legalised, but not yet implemented, these gruesome procedures.

Portugal and Colombia survive
Marcelo Rebelo de Sousa, the president of Portugal, has refused to sign a bill even though euthanasia and physician-assisted suicide have already been legalised in his country.  This is the second time he has rejected such a bill.  Last February, he vetoed the original bill because its wording was too imprecise.  However, this revised measure, which no longer requires patients to be terminally ill means, he insists is, ‘a considerable change of weighing the values of life and free self-determination in the context of Portuguese society.’  This euthanasia bill is now abandoned until a new parliament and government are chosen early in 2022.

Colombia is another story.  Bewildering is a good descriptive word.  In November, the country’s House of Representatives voted on a bill sponsored by the euthanasia campaigner, Congressman Juan Fernando Reyes Kuri.  It failed by 65 votes in favour and 78 against.  Yet way back in 1997, Colombia’s Constitutional Court ruled that euthanasia was legal.  However, the Court insisted that the county’s legislature must draft a suitable law.  In the supervening 25 years, no such law has been tabled.  Apparently, Colombia’s lawmakers have been resolutely against euthanasia.  Indeed, in the debate that preceded this recent vote, Congressman Buenaventura León declared, ‘The practice of euthanasia constitutes a serious offence against the dignity of the person and encourages the corrosion of fundamental values in a social order.  It would be very dangerous for the most fragile.  The Law is made to protect life.’

This section on ‘Euthanasia and Assisted Suicide’ in these Updates on Life Issues is always the most dreary and worrisome to write and read.  There is rarely anything positive to affirm.  When such unnatural deaths are authorised by law and performed by fellow citizens, it sends a clear message that civil society is crumbling.

Genetic Technologies
The CRISPR babies
Remember Lulu and Nana?  They were the twin girls who were at the centre of the shocking news that He Jiankui had used CRISPR editing to produce the first germline genome-modified human babies in 2018.  A recent article in Nature Biotechnology (2021, 39: 1486-1490) and entitled ‘The CRISPR children’ by Vivien Marx gives an update on the girls’ welfare.

However, the update is not very comprehensive.  It says, ’… their fate remains shrouded in secrecy amid swirls of rumours.  Many people contacted for this story refused to speak about the babies.’  What is known is that medical examinations have been performed on Lulu and Nana, including blood tests.  These were conducted at birth, at one and six months and at one year.  Liver function tests will follow at age five and IQ tests at age 10.  And there will be HIV testing.  Dr He’s original reason for using CRISPR-Cas9 was to alter the girls’ DNA to give them immunity from HIV.

Nevertheless, as laudable as this testing regimen appears to be, no results have yet been publicised.  And what about their mental health?  Perhaps this silence is all a case of medical confidentiality.  But these are special toddlers and the world is watching and waiting for information.  We know that CRISPR can be associated with mosaicism and very serious risks caused by genetic mutations and unexpected off-target modifications.  In other words, certainties about the potential risks of gene-editing and the uncertainties about Lulu’s and Nana’s health and welfare should prevent any further trials of human germline CRISPR editing.

A genetically-modified pig’s heart
David Bennett, a 57-year-old resident of Maryland, USA, has suddenly become famous.  He is the first person to receive a genetically-modified pig’s heart as an alternative solution to his cardiac problems.  For decades, doctors and scientists worldwide have dreamed of transplanting animal organs into people, a process known as xenotransplantation.  Pigs have similarly-sized organs to humans.  If porcine hearts could be used for transplants, the lengthy human waiting lists would shrink.

Bennett’s first signs of heart disease were in October 2021 when he began having severe chest pains.  In addition, he was suffering from fatigue and shortness of breath.  His uncontrollable arrhythmia prevented him from being fitted with a conventional artificial heart.  The transplant process began on 15 December, when Bennett agreed to be part of this experimental surgery.  Maryland officials submitted an application to the US Food and Drug Administration (FDA) on 20 December, requesting ‘compassionate use’ authorisation to proceed.  It was granted on New Year’s Eve.

So on 7 January, during surgery that lasted nine hours, a team of doctors, led by Muhammad Mohiuddin, attached Bennett to the heart of a one-year-old, 240-pound, gene-edited pig that had been bred explicitly for this purpose at the University of Maryland Medical Center.  Three days later, Bennett was breathing independently without the need of a ventilator.  However, he was still hooked up to an extracorporeal membrane oxygenation (ECMO) pump that assisted the circulation of blood around his body.  Doctors plan to wean him off it gradually.

Rejection is THE big obstacle in such transplants.  The pig was genetically prepared by Revivicor, a subsidiary of United Therapeutics and based in Blacksburg, Virginia.  Ten genetic modifications were carried out before the pig’s birth.  These involved turning off three porcine genes that typically trigger immediate rejection by the human immune system.  In addition, six human genes were added to prevent blood clotting in the heart and to improve molecular compatibility, thus further reducing the risk of rejection.  And one final gene was knocked out to keep the pig’s heart from responding to growth hormones so that it remained human sized.  No details of these modifications have been released for reasons of commercial secrecy and scientific competition.

Such innovative and controversial medicine is inevitably surrounded by clinical, regulatory and technical hurdles.  In addition, ethical objections come from animal rights activists, who are opposed to the use of pig organs, and from a growing cohort concerned about the ethics of producing these human-animal hybrids and their use in animal-human surgical procedures.

The immediate future of pig-human xenotransplantation depends on the recovery and future health of David Bennett.  Many already consider his surgery a success.  The intermediate future depends upon a supply of these specially-bred and genetically-modified pigs.  The longer-term future depends upon overcoming those clinical, regulatory, technical and ethical hurdles.
Meanwhile, as a postscript, Bennett has said that his favourite food is bacon!

Base-editing precision
CRISPR-Cas9 is the well-known and proven method for gene editing.  Base editing is somewhat different.  Instead of cutting and replacing a section of DNA, the enzyme DNA deaminase in conjunction with CRISPR–Cas9 can be used to change a target DNA base into another.  The disadvantage is that unregulated DNA deaminase activity can result in unwanted mutations, some of which can be hazardous.  To overcome this promiscuous shortcoming, scientists at the University of Pennsylvania have devised a method to split the DNA deaminase into two inactive parts.  These two components can then be safely introduced into a cell and triggered, by a cell-permeable compound called rapamycin, to reassemble and become the activated enzyme.

This work was published as ‘Controllable genome editing with split-engineered base editors’ by Kiara Berríos et al., in Nature Chemical Biology (2021, 17: 1262-1270).

The study’s senior author is Rahul Kohli, associate professor of medicine at the Perelman School of Medicine.  He has stated, ‘Our newly created split-engineered base editors really offer new potential for both research and therapeutics.’  The method seemingly allows for more controlled, more precise changes to be made at the target gene.  And it is thought that the technique now has the potential to be used in vivo.  Maybe it can be used to model diseases by altering a key gene.  And maybe it can offer doctors an option for editing a patient's genes for therapeutic purposes.

Stem-cell Technologies
Blood stem-cell treatment
Stem-cell treatments have, over the last 20 years or so, proved to be biologically startling, but also safe and efficient.  Yet, like all medical therapies, they can be improved.

Here is a typically small, but maybe significant step towards improvement.  It has been reported as, ‘Syndecan-2 enriches for hematopoietic stem cells and regulates stem cell repopulating capacity’ by Christina Termini et al., in Blood (2022, 139: 188–204).

The researchers, from the Department of Medicine, Cedars Sinai Medical Center, Los Angeles, discovered that a certain protein was expressed significantly higher in early, pluripotent blood stem cells than in later, more differentiated cells.  The team showed that this protein, syndecan-2, can identify primitive blood stem cells and also regulate stem-cell function, what they called ‘repopulating capacity’.

OK, this is a preliminary study in mice.  Nevertheless, when bone marrow cells were extracted from adult mice and their surface proteins categorised, the researchers discovered a population of hematopoietic stem cells (HSC) that could synthesise syndecan-2.  When these were transplanted into mice after irradiation (to mimic chemotherapy) the numbers of long-term blood stem cells increased by a factor of up to 10-fold, whereas when transplants of HSCs that lacked syndecan-2 were undertaken, the stem cells stopped replicating.

HSCs make all the blood and immune cells in the body.  Yet they make up less than 0.01% of the cells in bone marrow and peripheral blood.  They are essential in the treatment of cancers, such as leukaemia and lymphomas, yet they are typically destroyed by chemotherapy.  In other words, infusions of bone marrow and blood cells contain only a small concentration of therapeutic stem cells.  Maybe syndecan-2 can be used to select the best functional stem cells when carrying out stem-cell transplants.  For mice and for men.  This work has resulted in perhaps just a minor observation, but in the future, if you need an effective bone marrow transplant, after cancer treatment, this could be very welcome news.

Stem-cell gene therapy for Hurler syndrome
Hurler syndrome, formerly known as gargoylism, and technicality referred to as mucopolysaccharidosis type I, Hurler variant [MPS1-H], is a rare genetic disease characterised by skeletal abnormalities, cognitive impairment, heart disease and a reduced life expectancy.  It is caused by the incomplete removal of glycosaminoglycans (GAGs) from the body because of a lack of an enzyme, alpha-L iduronidase that breaks down GAGs.  The enzyme is encoded by the IDUA gene.  In other words, Hurler syndrome patients are IDUA-deficient.

An allogeneic hematopoietic stem-cell transplants, also known as bone marrow transplantation, is the standard therapy for Hurler syndrome.  However, this stem-cell treatment is only partially curative and associated with complications.

A team of researchers, mostly affiliated to the MPS1 team at the San Raffaele University, Milan, have been studying a group of eight children diagnosed with MPS1-H.  All of these patients lacked suitable allogeneic donors but had IQ scores above 80, meaning none had moderate or severe cognitive impairment.  The children received autologous (meaning from self, so the patient was the donor) hematopoietic stem and progenitor cells (HSPCs) that had been infected with an alpha-L-iduronidase (IDUA) gene using a lentiviral vector.  The planned duration of the study is 5 years.

An interim report has been published as, ‘Hematopoietic Stem- and Progenitor-Cell Gene Therapy for Hurler Syndrome’, by Bernhard Gentner et al., in New England Journal of Medicine (2021, 385: 1929-1940).

The children’s mean age at the time of HSPC gene therapy was 1.9 years.  After about 2 years of the trial, the procedure appeared to be safe.  All the patients showed rapid and continued engraftment of the gene-corrected cells.  In addition, they exhibited above normal physiological concentrations of blood IDUA activity within a month, which has been maintained.  Urinary glycosaminoglycan (GAG) excretion decreased steeply, reaching normal levels after 12 months in four of five patients who could be assessed.
Previously undetectable levels of IDUA enzyme activity in the cerebrospinal fluid became detectable after the gene therapy and were associated with local clearance of GAGs.  Furthermore, patients showed stable cognitive performance, stable motor skills corresponding to continued motor development, improved or stable findings on magnetic resonance imaging of the brain and spine, reduced joint stiffness and normal growth.

The authors concluded, ‘The delivery of HSPC gene therapy in patients with MPS1-H resulted in extensive metabolic correction in peripheral tissues and the central nervous system.’  Stem cells and gene therapy – what a powerful medical twosome!

Peter Singer wins the Berggruen Prize
That Aussie, utilitarian philosopher Peter Singer has won US$1 million just for thinking!  He was recently awarded the Annual Berggruen Prize for Philosophy & Culture.  The prize is given to a thinker ‘whose ideas have profoundly shaped human self-understanding and advancement in a rapidly changing world.’  Singer was cited as ‘an influential thinker whose practical ethics provided a framework for animal rights, effective altruism, and the global eradication of poverty.’  The selection jury of the Berggruen Prize chose him for his ‘widely influential and intellectually rigorous work in reinvigorating utilitarianism as part of academic philosophy and as a force for change in the world.’

All that praise may well be true, perhaps, even justified, but Singer has a darker side.  The Berggruen jury failed to mention his extreme views on bioethical issues, such as abortion, infanticide and euthanasia.

I have rarely agreed with Singer’s views.  Indeed, I have outlined several such disagreements in my 2014 book, Bioethical Issues.  For example, (on infanticide, p. 168), ‘Two other famous backers of infanticide are the bioethicists Helga Kuhse and Peter Singer.  In their notoriously shocking book, Should the Baby Live?, they presented their case for a twenty-eight-day period after a child’s birth during which treatment could be legally withheld.  Throughout this period, the child could be clinically assessed by an independent review panel, eerily reminiscent of the Nazi child euthanasia committees of the 1930s, before the verdict of life or death is pronounced.  These authors recommended the latter course when the child’s ‘life will … be one of unredeemed misery.’

On the beginning of human life, (p. 221), Singer writes in The New York Times, ‘“The crucial moral question is not when human life begins, but when human life reaches the point at which it merits protection.  Unless we separate these two questions … we are unlikely to achieve any clarity about the moral status of embryos.”’  ‘Such an approach fails to appreciate that it is factual evidence that determines the ethical practice – information decides policy, knowledge predicates deed.’  And again (p. 229), ‘Peter Singer and Deane Wells have argued the case in their book The Reproduction Revolution: ‘We suggest that the embryo be regarded as a thing, rather than a person, until the point at which there is some brain function.  Brain function could not occur before the end of the sixth week after conception.’

And there is more.  In his famous 1979 book, Practical Ethics, Singer argues in favour of abortion because foetuses are neither rational nor self-aware, and can therefore have no preferences.  As a result, he contends that the preference of a mother to have an abortion automatically takes precedence.  He has also argued in favour of voluntary euthanasia and some forms of non-voluntary euthanasia, including infanticide in certain instances, but he opposes involuntary euthanasia.

Peter Singer was born in Melbourne, Australia, in 1946, and educated at the University of Melbourne and the University of Oxford.  After teaching in England, the United States and Australia, he has, since 1999, been the Ira W. DeCamp Professor of Bioethics in the University Center for Human Values at Princeton University.  Singer intends to donate most of the Prize money to ‘The Life You Save’ charity and other organisations working towards ending animal suffering, especially in factory farming.  He will receive his Berggruen Prize at a ceremony to be held in Los Angeles in Spring 2022.

Sarah Weddington 1945 – 2021
Most have heard of Roe v. Wade, the legal case that in 1973 granted American women a constitutional right to abortion.  Few will have heard of one of the principal lawyers who successfully argued this landmark case.  She was Sarah Weddington, born Sarah Catherine Ragle in 1945 at Abilene, Texas.  She died, aged 76, on 26 December 2021.

Her father, Herbert, was a Methodist minister and as a child, Sarah was president of the Methodist youth fellowship at her church, played the organ, sang in the church choir and rode horses.

In 1964, she entered the University of Texas Law School and graduated three years later.  In 1967, during her third year of law school, Catherine Ragle became pregnant by Ron Weddington and she travelled to Mexico for an illegal abortion.  From 1968 to 1974, she was married to Weddington.  After her divorce, Sarah continued to live alone in Austin, Texas.

After University she joined with a group of graduate students who were researching ways of challenging various abortion laws.  It was not long before she met a 21-year-old mother of two who was pregnant again.  Her name was Norma McCorvey
.  She had visited a local attorney seeking help in obtaining an abortion, but instead he assisted McCorvey with handing over her third child for adoption and after doing so, he referred her for additional advice to Weddington and Linda Coffee.  The latter fellow lawyer was to become co-counsel with Weddington in Roe v. Wade.

The two lawyers were looking for somebody – anybody – to further their own pro-abortion legal ambitions.  They managed to persuade McCorvey to become the plaintiff in a test case alleging that the Texas anti-abortion law of 1959 was unconstitutional.  And so between 1970 and 1973, Weddington and Coffee argued for their client Norma McCorvey, who, to protect her identity was referred to in the legal documents as ‘Jane Roe’.  Weddington’s opponent was Henry Wade, the Dallas district attorney.  After winning and then losing on appeal, the case arrived at the US Supreme Court (SCOTUS) which, in 1973, voted 7 to 2 that access to abortion was a constitutional right and struck down conservative state laws.  Later McCorvey believed that she had been set up by the pro-choice movement and especially by the two women lawyers.  At just 26, Weddington was one of the youngest lawyers ever to win a case before the SCOTUS.

That SCOTUS ruling on abortion has stood for nearly 50 years but it remains a bitterly-contested issue with access to terminations now varying across different states.  In 1998, Weddington voiced her concerns as state-led abortion limitations began to spread across the United States.  She reasoned, ‘I think of Roe v. Wade as a house that’s sitting on the edge of a beach, where the water is coming under it and taking the sand out.  The house is still standing there, but it is more and more in danger of collapsing in the water.’  Weddington’s analogy may well have been prescient – observers are currently expecting that the SCOTUS may overturn the federal Roe v. Wade later this year, which in turn will lead to several total abortion bans at the state level soon after.

After arguing Roe v. Wade, Sarah Weddington was elected to three terms, from 1972 to 1977, in the Texas House of Representatives before serving as general counsel to the US Department of Agriculture under the Jimmy Carter administration from 1978 to 1981 and then becoming a lecturer at Texas Woman’s University from 1981 to 1990.

Sarah Weddington died on Boxing Day 2021 ‘after a series of health issues’.  Some have noted that her death occurred shortly after the SCOTUS had heard the oral arguments in Dobbs v. Jackson Women's Health Organization, the upcoming case reconsidering that key decision in Roe v. Wade in which Weddington had played such a decisive part.

The first Tesla baby
Joined-up happy stories, however contrived, can be amusing.  Here is one featuring Elon Musk, the billionaire CEO of Tesla Inc., and Yarin Sherry, a young mother from Wayne, Pennsylvania.

In a recent interview with The Wall Street Journal, Elon Musk dismissed the concerns of many about world overpopulation.  He, rightly, expressed the view that people should actually be concerned about rapidly declining birth rates across much of the world.  As he said, ‘Depopulation is the real problem.’  Look at the data.  According to a 2020 study in The Lancet, 183 of 195 countries are expected to have a fertility rate below replacement level by the end of the century.  Already in almost all of the rich, developed counties, birth rates are less than 2.1 children per woman, less than needed to maintain stable populations.  Or as Mr Musk put it rather more bluntly, ‘Please look at the numbers.  If people don’t have more children, civilisation is going to crumble.  Mark my words.’

At about the same time, but way across the other side of the USA, the pregnant Yarin Sherry and her husband, Keating, were getting their 3-year-old son, Rafa, ready for preschool when her waters broke.  Thinking she still had time before their daughter’s arrival, Yarin told her husband to drive their son to school first.  Keating disagreed.  ‘She was telling me to drop Rafa off to school.  But I figured time was of the essence,’ he said.  So he began driving his wife to the hospital, but they got stuck in morning traffic.  Help!  Suddenly, Yarin gave birth in the front of the car!  But this was not any ordinary car.  This was a Tesla – one of Elon’s autos.  So when Keating switched it to autopilot mode it allowed him to focus on his wife and calm the tension of that frenetic morning.  And it got Yarin and her new-born, Maeve Lily, to hospital securely.

Thank you, Elon.  Your smart car helped the declining birth rate, just a teeny-weeny bit.  Thank you, Yarin.  Your daughter is the first Tesla baby, born safe and sound.  OK, so this happy link is a little tenuous.  But it proves that the versatile Tesla can also act as an ambulance.

USA and Elsewhere
Pushing back on abortion in the USA
According to the results from the pro-life Operation Rescue’s annual survey, the number of abortion facilities in the USA increased in 2021.  Today there are 720 abortion clinics in the US – 14 more than were operating in 2020.  During 2021, a total of 41 new abortion locations opened or resumed abortions in 2021, while there were 27 abortion facilities that closed or halted abortions.  This total of 720 represents the largest increase in abortion services since 2016, but it is still far below the all-time high of 2,176 abortion facilities in 1991.  So this news is patchy – good and bad – but always life-threatening.

And at the other end of abortion activism, according to a report from the pro-abortion Guttmacher Institute, 19 states passed a record 106 pro-life laws, including several abortion bans, during 2021.  There were more abortion restrictions in 2021 than in any other year – the previous record was in 2011 when states passed 89 pro-life laws.  If and when Roe v. Wade is overturned, these state-wide bans could protect tens of thousands of unborn children every year.  Elizabeth Nash, the author of the report, described 2021 as ‘the worst year for abortion rights in almost half a century.’  On the other hand, this means that 2021 was an excellent year for unborn babies and their mothers.

In addition, 2021 has proved to be an historic time in the fight to restore unborn children’s right to life in America.  Most notably, the Texas Heartbeat Act, which bans abortions once an unborn child’s heartbeat is detectable, at about six weeks, went into effect on 1 September.  And there is the Mississippi case of Dobbs v. Jackson Women's Health Organization which recently reached the Supreme Court of the United States (SCOTUS).  With its upper abortion limit of 15 weeks, it is a direct challenge to Roe v. Wade though the Court’s ruling is not expected until Summer 2022.

These activities are giving Americans hope that the SCOTUS may overturn the federal Roe v. Wade and allow individual states to protect the unborn from abortion again.  Even abortion activists are admitting that, while some women are travelling to other states for abortions, many others are having their babies instead.  The year of 2022 could well turn into a celebration for the unborn and their mothers.

UPitt and foetal research
The University of Pittsburgh is still in trouble.  For months it has been accused of operating a foetal research programme with allegations that include the illegal harvesting of kidneys from aborted babies while their hearts were still beating.  Moreover, this research project at the University is also claimed to have been unlawfully supported by taxpayer’s money.

UPitt has continued to defend these alleged experiments.  The university has hired the Washington DC law firm of Hyman, Phelps & McNamara to conduct an investigation.  In mid-January, its report found that UPitt’s research is ‘fully compliant’ with state and federal laws.

However, many observers are critical of UPitt’s decision to hire a law firm as if that somehow counts as an ‘independent’ review.  In addition, there has been further evidence of gruesome experiments, such as the scalping of second-trimester aborted babies and the subsequent implanting of their scalps onto rodents in order to study the human immune system.  This research, including numerous pictures of the tufts of growing hair, was published as ‘Development of humanized mouse and rat models with full-thickness human skin and autologous immune cells’ by Yash Agarwal et al., in Scientific Reports (3 September 2020).

State and federal lawmakers, pro-life organisations and others have been calling for a robust and impartial investigation of the university for months.  In reply, UPitt continues to call the allegations ‘irresponsible and false.’  This case could run and run.

IVF in Spain
Single women and members of the LGBTQ+ community will now be able to use IVF financed through Spain's public health care system.  Since 2013, access to state-funded fertility treatment was limited to heterosexual women who had a male partner, forcing everyone else to pay for private treatments.

On 5 November, the Spanish health minister, Carolina Darias, signed an order allowing ‘people with a uterus’ to access free assisted reproductive technologies irrespective of relationship status.  She said, ‘We have restored rights that should never have been abolished.’

This measure will not apply to male same-sex couples or transwomen who want to become parents, as surrogacy remains illegal in Spain.  This is not the only controversial change in Spanish law.  This past summer, the government approved a draft bill that gives people over the age of 16 the ability to change their gender without approval from either parents or doctors.

Abortion in Poland
Poland has some of the strictest abortion laws in Europe – they consist of a near total ban.  In January 2022, tens of thousands of Poles took to the streets to protest a Constitutional Tribunal ruling from October 2020.  It declared that terminating pregnancies with foetal defects was unconstitutional.  As the new ruling came into effect, it eliminated the most frequently used reason for obtaining a legal abortion.

In addition, the death of a pregnant Polish woman has reignited the country’s debate over abortion.  Activists say Izabela, a 30-year-old woman in week 22 of her pregnancy, died of septic shock after doctors apparently waited for her unborn child’s heart to stop beating.  She is allegedly the first woman to die as a result of the ruling.  The government, Poland's ruling Law and Justice party, says the new ruling was not to blame for her death, but rather it was an error by doctors.

Izabela went to hospital in September 2021 after her waters broke, her family said.  Scans had previously shown numerous defects in the foetus.  Izabela said in a text message to her mother, ‘The baby weighs 485 grams.  For now, thanks to the abortion law, I have to lie down.  And there is nothing they can do.  They'll wait until it dies or something begins, and if not, I can expect sepsis.’  When a scan showed the unborn child was dead, doctors at the hospital in Pszczyna, southern Poland, decided to perform a Caesarean.  The family's lawyer, Jolanta Budzowska, said Izabela's heart stopped on the way to the operating theatre and she died despite efforts to resuscitate her.  In a statement on its website, the Pszczyna County Hospital said it shared the pain of all those affected by Izabela's death, especially her family.

On 19 November, the Hospital said it had suspended two doctors who were on duty at the time of the death.  The Hospital has also declared, ‘It should ... be emphasised that all medical decisions were made taking into account the legal provisions and standards of conduct in force in Poland.’  As for the protestors claim that it was the country’s anti-abortion laws that were responsible, Poland's government rejects such claims that the Constitutional Tribunal ruling was to blame for Izabela's death, instead attributing it to a mistake by doctors.  The Polish prime minister, Mateusz Morawiecki said, ‘When it comes to the life and health of the mother ... if it is in danger, then terminating the pregnancy is possible and the ruling does not change anything.’

This is a most sad and complex case.  Abortion, with the one intended death of the unborn child, is bad enough.  But when a second death, that of the mother, also occurs, it is an even greater tragedy.  Who is to blame?  The law, the doctors?  Maybe neither, maybe both depending primarily on your stance on abortion.  But there is no denying that the very best medical law and practice will always defend and uphold the dignity and worth of all human life, of both unborn children and their mothers.  This Polish case regrettably failed both.
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