Update on Life Issues - June 2024


The general election
A word in season.  You may have a pro-life MP – good for you.  Or you may not – join the club.  Whichever, this is an opportune time to meet them and ask them some pointed bioethical questions.  Now, you know that I would not ask you to do something I’m not prepared to do.  So, my wife and I visited our MP last month.  We questioned him particularly about his views on abortion and assisted suicide – he was polite, but fairly non-committal.

Our meeting lasted a good 30 minutes.  There were several questions we forgot to ask him.  What is the basis of his moral framework?  Does he have any church involvement?  When does he think human life begins?  Has he had recent representations from others of a pro-life persuasion?  And so on.  These are for another time.

But we are now better prepared to quiz those canvassers whenever they ring our doorbell.  Go for it.

Abortion statistics for 2022
Here at last are the long-overdue numbers for 2022, released at 09.30 on Thursday 23 May 2024.  The relevant information may be viewed here (cut and paste if necessary): https://www.gov.uk/government/statistics/abortion-statistics-for-england-and-wales-2022/abortion-statistics-england-and-wales-2022

As ever, there is no comfort in these cold, unemotional statistics.  The total number of abortions performed on residents of England and Wales during 2022 was 251,377.  It is the first time that the quarter of a million barrier has been breached.  It is an increase of 17% over the previous year.  It is an average of 967 each weekday.  It is less than the genuine total because it takes no account of abortions caused by the mifepristone-misoprostol pill combination, or those completed by the morning-after pill.

How do you describe such numbers?  Scandalous?  National scandals and their associated Public Inquiries are becoming part of our lives.  There have been Hillsborough, infected blood, Covid-19, Post Office and many more scandals.  And now this abortion scandal.  Sadly, the latter will not be the subject of a Public Inquiry.

Here are some key data to sketch out this abortion scandal.  In 2022, 99% of these abortions were funded by the NHS, with 80% of them subcontracted to the independent abortion-provider sector.  In other words, they were taxpayer funded.  And 86% were medically induced with pills, as opposed to performed surgically.

The vast majority (98%, 247,440) were performed under ground C, the so-called ‘social clause’ for reasons far and wide.  There were 3,124 abortions performed under ground E, the 'handicap clause’ and 545 of these were at 22 weeks and later.

Overall, most (88%) abortions were performed at under 10 weeks.  There were 1,952 performed at 22 weeks and over, with 260 at over 24 weeks – above the legal limit.

Of all the women having abortions in 2022, 41% had already undergone one or more previous abortions.  This repeat rate has increased from 37% in 2012.  There were 72 selective terminations, where more than one embryo has inconveniently implanted, usually as a result of overzealous IVF transfers.

Besides the 251,377 abortions for residents of England and Wales, there were 745 for non-residents, plus 172 for residents of Northern Ireland and 16,584 from Scotland.  In other words, the total number of officially recorded abortions occurring throughout the United Kingdom during 2022 was 268,878.  Each one is now a lifeless child alongside a childless mother.  How do you regard that?  Are you horrified, troubled, or complacent?

Abortion at Westminster
On Wednesday 22 May, the prime minister made a surprise announcement that the date for the next general election would be Thursday 4 July.  This means that many pieces of pending Government legislation were lost, including the Criminal Justice Bill.  This had become a ‘Christmas tree’ bill with all sorts of miscellaneous attached tinsel that disguised its main and important purposes.  Among the inappropriate hangings were two amendments concerning the decriminalisation of abortion.

Two MPs with extreme views on abortion, namely Diana Johnson and Stella Creasy, had tabled amendments to this upcoming Criminal Justice Bill.  These would allow abortion for any reason, up to 40 weeks, with no legal sanctions.  Abortion would become merely a woman’s health issue.  Such amendments to abortion law are far too serious to be merged into this catch-all Bill.

The pro-life lobby was nervous.  Would the Speaker of the House select one, both or neither of these amendments from among the 140 or so others that had been proposed?  Whichever, the all-important Report stage of the Bill was scheduled for Wednesday 15 May.  It was then rumoured to be the next day, then the next week.  Eventually Parliament was prorogued on Friday 24 May and dissolved on Thursday 30 May.  So, thankfully, the decriminalisation attempts were lost.  Hooray!  But they will be back, probably in the next Parliament.

Besides the miserable decriminalisation issues there were two jolly pro-life amendments.  First, there was a Bill promoted by Caroline Ansell MP that would reduce the current upper time limit for abortions from 24 to 22 weeks.  This is in line with advances in the neonatal care of newborns, who are now not only regularly born, but also survive, at this age.

Second, Liam Fox MP had tabled his Down’s Syndrome Bill, which would lower those ghastly abortions up to 40 weeks for the disabled to 24 weeks, the same upper limit as most other abortions.  Specifically, it would eliminate the apartheid that labels the disabled as second-class citizens with lives that are not worthy to be lived.  This Bill had at least 55 sponsors.  But it too was lost in the so-called ‘wash-up’ at the end of this Parliamentary session.

IVF and ARTs
The global IVF market
Vision Research Reports is a worldwide market research and consulting organisation based in Ottawa, Canada.  According to its recent Report entitled, ‘In Vitro Fertilization Market Size & Trends’, the global IVF market was valued at USD 25.3 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.54% from 2024 to 2030.  In other words, IVF is hugely widespread and hugely profitable.

The Report is primarily concerned with financial aspects of IVF.  However, it also includes an astute summary of several bioethical aspects that underlie the reasons for the projected growth in global IVF.  If you wish to understand IVF, here, verbatim, are five market trends identified by this Report:

1]  Rising Demand for Genetic Testing: Increased awareness and acceptance of genetic testing techniques, such as comprehensive chromosomal screening (CCS) and preimplantation genetic diagnosis (PGD), are driving demand for IVF procedures with a focus on selecting genetically healthy embryos.

2]  Expansion of LGBTQ+ Family Building: The LGBTQ+ community’s growing interest in family building through assisted reproductive technologies, including IVF and surrogacy, is fuelling market growth and prompting clinics to offer inclusive services tailored to diverse family structures.

3]  Emergence of Low-Cost IVF Clinics: The proliferation of low-cost IVF clinics and alternative pricing models is making IVF more accessible to a broader segment of the population, driving competition and potentially reducing treatment costs.

4]  Telemedicine and Remote Monitoring: The integration of telemedicine platforms and remote monitoring technologies into IVF services allows for greater convenience, flexibility, and patient engagement throughout the treatment process, particularly in light of the COVID-19 pandemic.

5]  Focus on Patient-Centric Care: IVF clinics are increasingly prioritizing patient experience and satisfaction by offering personalized treatment plans, comprehensive support services, and transparent communication to ensure a positive journey through fertility treatment.

In addition to these market trends, the Report identifies five market drivers of IVF:

1]  Increasing Prevalence of Infertility: The rising prevalence of infertility due to factors such as advanced maternal age, lifestyle changes, and medical conditions contributes to the growing demand for IVF services.  As more couples experience difficulties conceiving naturally, they turn to assisted reproductive technologies like IVF as a solution.

2]  Advancements in Technology: Ongoing advancements in IVF technology, including improvements in embryo culture techniques, cryopreservation methods, and genetic screening technologies, enhance the success rates and safety of IVF procedures.  These technological innovations attract patients seeking more effective and personalized fertility treatments.

3]  Growing Awareness and Acceptance: Increased awareness and acceptance of IVF as a viable option for achieving pregnancy contribute to market expansion.  Education initiatives, media coverage, and celebrity endorsements have helped destigmatize infertility and promote IVF as a mainstream reproductive option.

4]  Demographic Trends: Changing demographic trends, such as delayed childbearing and increasing rates of same-sex couples and single individuals seeking parenthood, drive demand for IVF services.  As individuals and couples postpone childbearing for various reasons, they rely on IVF to overcome age-related fertility challenges.

5]  Rising Healthcare Expenditure: Increasing healthcare expenditure and rising disposable incomes enable more individuals and couples to afford IVF treatments.  Despite the high costs associated with IVF, patients are willing to invest in fertility services to fulfill their desire for parenthood, driving market expansion.

The above insights come from an unexpected source.  They confirm that IVF, with all its bioethical dilemmas, health dangers and costs, is here to stay, even expand.  However, the unceasing bioethically-sound advice is, stay away from all aspects of assisted reproductive technologies (ARTs), including IVF.

Gamete donor compensation

In most parts of the UK, when someone donates their ova or sperm at a fertility clinic, they receive financial compensation.  Currently, sperm donors receive £35 per clinic visit and ova donors receive £750 per cycle.  These rates were last set in 2011 when the Human Fertilisation and Embryology Authority (HFEA) felt that these compensation amounts struck the right balance between covering donor expenses and donors feeling valued, but not enough to remove the altruistic motivations behind donating gametes.  They were regarded as reimbursement of donor expenses rather than donor payment.

However, since 2011, inflation has taken its toll.  At its 20 March 2024 meeting, the HFEA discussed donor compensation and decided to increase the payments in line with cost-of-living inflation to £45 for sperm donors and £985 for the more-medically invasive ova donors based in the UK.

Patients receiving donor treatment may choose to use gametes donated at a UK clinic, or they may choose to import gametes donated abroad and imported into the UK.  In recent years the use of imported sperm has increased.  In 2011, imported donations represented around 27% of new sperm donors.  By 2021, 65% of new sperm donors were from overseas.  In 2020, donor imports from the USA and Denmark accounted respectively for 27% and 21% of new sperm donors registered in the UK.  Donor ova are less frequently imported, with only 4% of ova imported in 2011, decreasing to 1% in 2021.

When considering overseas donations, it is clearly not practicable to introduce individual compensation rates for every country.  Therefore, also at its 20 March 2024 meeting, the HFEA agreed to bring overseas donor compensation rates in line with those of the UK.

The bioethically-disastrous Warnock Report (1984), which has since governed thinking and practice in human reproduction and embryo research, and which prefaced the 1990 Human Fertilistion and Embryology Act, recommended that IVF treatment should be generally available, regardless of whose gametes were involved, with no restriction on the supply, use, sale or purchase of ova, sperm or embryos, with no constraints on ova donation, and so on.  In other words, it approved the wholesale trading of human gametes and embryos.

Forty years on, those recommendations should still make us all uncomfortable.  Is the trafficking and marketing of gametes, those biological components that make us individually unique, a wholesome and praiseworthy activity?

Fertility clinics in trouble
IVF and most of the other assisted reproductive technologies (ARTs) involve complex and potentially dangerous procedures.  They are prone to failure.  After all, IVF typically has a 70% failure rate.  In addition, sometimes human errors arise.  The main task of the Human Fertilisation and Embryology Authority (HFEA) is to devise the ART safety rules and ensure that all practitioners abide by them.

One of the latest safety catastrophes came to light in early March 2024 at the Homerton Fertility Centre in East London.  The HFEA suspended its operating licence over what were described as ‘significant concerns’.  The Centre has admitted there had been three separate incidents.  They were ‘errors in some freezing processes’, ‘a small number of embryos’ had perished or were ‘undetectable’, meaning, they could not be found after thawing.

The Centre has informed its clients and apologised for the distress that the errors may have caused.  According to a BBC report, as many as 150 embryos, belonging to up to 45 patients, could have been destroyed or lost.  The HFEA is now conducting its own investigation alongside that of the Centre.  Interim measures now require all staff to work in pairs to ensure all clinical activities are checked by two healthcare professionals.  In addition, competencies of staff within the unit have been rechecked, and security at the unit has been increased.

In February 2024, another IVF disaster came to light in the UK.  A number of women were affected by the use of a faulty freezing solution at fertility clinics in London and Sheffield.  The HFEA confirmed that the only clinics affected were Guy’s and St Thomas’ assisted conception unit in London and Jessop Fertility in Sheffield.  The clinics attributed the incidents to a batch of faulty freezing solution from CooperSurgical, a US-based company.  It was reported that frozen ova and embryos may have been destroyed.  Though it was known in March 2023 that the freezing fluid had been mislabelled, the women at risk were informed only in February 2024.  The London hospital has since apologised to 136 women after their ova and embryos were probably damaged during the freezing process.  The Sheffield hospital said it had identified 29 people who had ova or embryos frozen in August 2022, when the particular product batch was used.

Rachel Cutting, the HFEA’s director of compliance and information, speaking on behalf of the Authority, stated that, ‘Fertility treatment in the UK is generally very safe.  Our most recent report shows that out of the almost 100,000 treatment and storage cycles which took place in 2022/23, more than 99% were conducted without any incidents occurring.’  Yes, yes, yes.  1% may sound pretty minor, but it is equivalent to as many as 1,000 incidents.  Such occurrences can deeply trouble women who have lost ova and embryos as well as their prospects of pregnancy.  Some were cancer patients who have since undergone treatments, such as chemotherapy or hysterectomies, and therefore missed their opportunity to preserve their fertility.

Of course, such errors in IVF procedures are not restricted to UK fertility clinics.  The burgeoning practice of IVF in the USA inevitably includes adverse incidents.  One recent example has been reported in April 2024.  Several couples are now suing a southern Californian fertility centre over claims that its staff destroyed their embryos in a ‘toxic incubator’ yet subsequently transferred deceased embryos to its patients.  So far 11 couples have instituted legal proceedings against the Ovation Fertility clinic at Newport Beach, California, with more lawsuits expected.

The problem came to light when Ovation noticed a 0% success rate among their IVF patients.  For some victims, this was their last chance to have a biologically-related child.  It is alleged that the Ovation clinic staff mistakenly cleaned an incubator containing the embryos of dozens of patients with hydrogen peroxide instead of the usual sterile solution.  The use of peroxide killed the embryos that nevertheless were transferred to the plaintiffs between 18 January and 30 January 2024, none of whom became pregnant.

According to Adam Wolf, attorney acting for some victims, ‘My clients are devastated by Ovation’s serious error.  The only thing we can seek is monetary compensation and accountability from Ovation.  We want to know what happened, how it happened, and they want to make sure this never happens again.’  All of the plaintiffs are seeking a jury trial and are suing on several grounds including negligence, medical battery and intentional representation.

This example is a not unexpected calamity for the largely unregulated IVF industry in the USA.  It is where those two great professions of law and medicine conjoin.  While the court battles continue, the real losers in this war are the parents of the hoped-for babies, and, of course, the embryos themselves.

The bioethical mantra still stands – IVF is best avoided.

Euthanasia and Assisted Suicide

Jersey takes the wrong step

It has been a long and dreary road.  Back in November 2021, Jersey politicians approved ‘in principle’ the legalisation of assisted dying on the Island.  The voting was 36 in favour, 10 against and three absent.  So Jersey’s Parliament became the first in the British Isles to vote in favour of legalising assisted suicide.

Public engagement and consultations, reviews and dialogues, reports and publications followed.  During May 2024, the States Assembly met and debated two Routes through which people, who have lived in Jersey for longer than a year, are 18 or over and have decision-making capacity, could apply for assisted suicide.

On Wednesday 22 May, Assembly members voted to approve plans to legalise assisted suicide for those with a terminal illness ‘causing unbearable suffering’.  A total of 32 members voted in favour while 14 voted against this so-called Route 1.  Route 2, for those who are not terminally ill but who have an ‘incurable physical medical condition causing unbearable suffering’, was rejected by a majority of 27 to 19.

The vote on that Wednesday was significant, but it is not the end of the road.  States members have merely given Deputy Tom Binet, Minister for Health and Social Services, permission to proceed to draft new legislation.  It must still go through several bureaucratic and legal approval hoops.  It could still be rejected.

As Tom Binet has stated, ‘The next step is the law drafting [for Route 1], which will take up to 18 months.  The draft law will then need to be debated [and approved] by the Assembly [by the end of 2025], followed by an 18-month implementation period, with the new law [if approved] coming into effect in summer 2027.’

And now the Isle of Man
The legalisation of assisted suicide and euthanasia for residents on the Isle of Man may have become a step closer after crucial votes by its members of the House of Keys (MHKs) during May 2024.

The Assisted Dying Bill, originally introduced by Dr Alex Allinson, passed its second reading (17 to 7) in October 2023.  The Bill has since been debated in its Clauses stage.  On 7 and 14 May, two key changes were approved.  First, MHKs voted (14 to 10) to increase the required residency period on the Island from one year to five, amid concerns that it could encourage so-called ‘death tourism’.  Second, MHKs supported (15 to 9) a change to allow those with less than a year to live, the right to die, rather than six months as originally proposed.

The Clauses stage is likely to continue on 11 June.  Afterwards, the Bill is expected to receive a Third Reading in the House of Keys this summer.  If it passes this stage it will progress onto the Legislative Council, the Upper House of the Tynwald, for further debate and scrutiny.  The Bill could then receive Royal Assent as soon as next year, followed by consideration of how the legislation will be implemented.  Assisted suicide deaths could potentially become available for Manx residents as soon as 2027.  Thus, the Island could become the first part of the British Isles to pass assisted suicide legislation.

Both the Isle of Man and Jersey are crown dependencies which set their own laws.  However, approval of assisted suicide in either jurisdiction could have serious implications for the UK mainland.

And in Scotland
Or could Scotland become the first jurisdiction in the United Kingdom to legalise assisted suicide?  On 28 March 2024, Scottish Liberal Democrat, Liam McArthur formally tabled in the Scottish Parliament his private member’s measure, the Assisted Dying for Terminally Ill Adults (Scotland) Bill.  He said that, ‘This Bill contains robust safeguards, similar to those which have been safely and successfully introduced in countries such as Australia, New Zealand and the United States, where they continue to enjoy strong public support.’

The Bill will now be scrutinised by the Health Committee, before the so-called Stage 1 debate and voting by MSPs, which is likely to occur later this year.  If approved, the Bill then progresses to Stage 2, where MSPs can propose amendments.  If these are agreed, the amended version is considered at Stage 3.  This is the final debate and vote before a Bill becomes law via Royal Assent.

Liam McArthur has stated that, ‘I’m confident Parliament will back my proposals to give terminally ill adults the choice they need.’  However, it is far from certain that this third attempt in recent years to legalise assisted dying at Holyrood will pass on a conscience vote.  The former First Minister, Humza Yousaf, is opposed, along with the Church of Scotland, the Catholic Church in Scotland, and the Scottish Association of Mosques, plus thousands of ordinary citizens.

Perhaps more surprisingly, the earlier First Minister, Nicola Sturgeon, who is still very influential in Holyrood and beyond, says that she is leaning towards a No vote.  In the Glasgow Times (3 April 2024), she wrote, ‘… the more deeply I think about the different issues involved, the more I find myself veering away from a vote in favour, not towards it.’

She continued with an excellent opposing testimonial, ‘I worry that even with the best of intentions and the most carefully worded legislation, it will be impossible to properly guarantee that no-one at the end of their life will feel a degree of pressure, a sense that it might be better for others for them not be here – even if their loved ones try to persuade them otherwise.  And, even more, fundamentally, I worry about the thin end of the wedge.  That if we normalise assisted dying – if we come to associate dignity at the end of life with choosing to die, rather than being supported to live in as much peace and comfort as possible – then we will, as a society, lose focus on the palliative and end-of-life care and support that is necessary to help people, even in the worst of circumstances, to live with dignity.  And I worry that, over time, this shift in collective mindset will see the tightly drawn provisions of this bill extended much further.’  Well said, wee Nicola!

And in England and Wales
Assisted dying is still strictly illegal in England and Wales.  Successive UK Governments have so far ruled out attempting to introduce any permissive legislation.  The last Westminster Bill, debated in 2015, was defeated by 330 to 119.  However, a recent petition, organised by Dignity in Dying, called on the Government to allocate Parliamentary time for assisted dying to be fully debated in the House of Commons and to give MPs a free vote on the issue.  Because it was signed by more than 100,000 people a debate was automatically triggered.  On 29 April that e-petition debate on assisted dying took place in Westminster Hall.

Another Westminster grouping has also been busy discussing the issue.  Since December 2022, the Health and Social Care Select Committee has been convening the first-ever House of Commons inquiry into assisted dying.  The Committee, chaired by Steve Brine MP, aimed to ‘gather the most up-to-date information and views on the topic to inform Parliament and the wider public.’  A cross-party Committee of MPs has heard months of evidence, data and personal accounts on assisted suicide.  The Committee received more than 68,000 responses from members of the public and more than 380 pieces of written evidence.  On 29 February 2024, the Committee published its Report.

The full Report, entitled, ‘Assisted Dying/ Assisted Suicide Second Report of Session 2023–24’ is available here: https://committees.parliament.uk/publications/43582/documents/216484/default/ (cut and paste if necessary).

The Report has generally been well received as a fair-minded response to a complex topic.  It calls on the Government to be ‘actively involved’ in the assisted dying debate as reform becomes ‘increasingly likely’ across the British Isles.

Yet, perhaps wisely, to the relief of opponents and dismay of supporters, the Report made no recommendations concerning a change of law.  It stated, ‘Although select committees usually make recommendations to Government, in respect of [assisted dying] the Government has made it clear that it will not take any steps towards legalising [it] but instead that this would be Parliament’s role, should members wish to do so.’

The Report also concluded that while the UK had long been a world leader in palliative and end-of-life care, access and provision was now ‘patchy’.  It said, ‘The Government must ensure universal coverage of palliative and end-of-life services, including hospice care at home.'  And it called for the Government to commit to an uplift of funding to guarantee support for hospices that need financial help.  Currently hospices receive only a third of their funding from the NHS, despite providing the majority of the palliative care.

It further described a ‘pressing need’ for better mental health support for terminally ill people and said the Government should commission research on the subject then report to Parliament.  And there should be a ‘national strategy for death literacy and support following a terminal diagnosis’ to help professionals better support a dying person and their loved ones.

Steve Brine MP, the Committee chairman, confirmed that, ‘The inquiry on assisted dying and assisted suicide raised the most complex issues that we, as a committee, have faced, with strong feelings and opinions in the evidence we heard.’

‘We intend the information and testimony we present in our Report today to have a lasting legacy and, as we set out in the initial terms of reference, be a significant and useful resource for future debates on the issue.  That could still be during this Parliament, of course, or after the next general election.’

The Government has briefly responded to the Report.  This was immediately before MPs debated that Parliamentary petition with more than 100,000 signatures, calling for the Government to allocate time for a full debate on assisted dying and for MPs to be given a vote on the issue.

The three-hour debate was well attended with contributions from many MPs and from many perspectives.  Of course, not much significant headway can be achieved in 180 minutes on such a huge topic, but it was a useful testing of the waters exercise.  No votes were taken.  Dignity in Dying thought it had won the day.  Others thought otherwise.

One of the great unknowns at this debate was the impending call a few days later for a 4 July general election.  Both prime minister, Rishi Sunak, and the leader of the opposition, Sir Keir Starmer, have committed to ensuring time to debate assisted suicide if either is successful in their respective bids to lead the next Government following that general election.  We will be back.

Genetic Engineering

Gene therapy for deafness
Opal Sandy from Oxfordshire was born with congenital deafness.  When she was four days old, doctors told her parents that she was completely deaf.  Now her hearing has been restored after she became the first person in the world to take part in a revolutionary trial using a gene therapy called DB-OTO and produced by Regeneron, an American biotech company.  One in every 500 children is born with some form of auditory neuropathy.  Most of these cases are caused by genetic variations, with mutations in the OTOF gene accounting for between 1 and 8%.

Opal’s deafness was due to a variant of this OTOF gene which impairs the production of the OTOF protein that is critical for the communication between the sensory cells of the inner ear and the auditory nerve.  She received the gene therapy as part of the international CHORD clinical trial taking place in the UK, Spain and the USA.  The Phase 1 trial is looking at the use of DB-OTO for children with OTOF mutations.  The DB-OTO procedure, which took place at Addenbrooke's Hospital in Cambridge, consists of injecting a modified adeno-associated virus (AAV1) that carries a working copy of the human OTOF gene into the inner ear.  It was conducted in Opal’s right ear, shortly before her first birthday.  At the same time, a cochlear implant was fitted in her left ear, to ensure she could hear as soon as possible.

Three weeks after having the treatment, at eleven months of age, the toddler responded to sound, even with the cochlear implant switched off.  She improved continuously and after six months clinicians confirmed she had close to normal hearing levels for soft sounds. Then, at 18 months old, she started to speak.

Professor Manohar Bance, chief investigator of the CHORD trial and ear surgeon at Cambridge University Hospitals NHS Foundation Trust, has said, ‘Gene therapy has been the future of otology and audiology for many years and I'm so excited that it is now finally here.  This is hopefully the start of a new era for gene therapies for the inner ear and many types of hearing loss.’

The ongoing CHORD clinical trial has three Phases and includes 18 children worldwide.  Phase 1, in which Opal participated, consists of receiving a low dose of the DB-OTO infused into one ear of three deaf children.  Following proven safety in Phase 1, another three children in Phase 2 will have a higher dose administered to one ear.  Finally, if the previous two Phases are proven to be safe, Phase 3 will consist of injecting the therapy into both ears of another cohort of deaf children.

Already, a second child enrolled in the CHORD clinical trial, and dosed at 4 years of age, is showing similarly positive results six weeks after treatment.  Professor Bance added, ‘We have a short time frame to intervene because of the rapid pace of brain development at this age.  Delays in the diagnosis can also cause confusion for families as the many reasons for delayed speech and late intervention can impact a children's development.'

Who doesn’t like to hear such good news from successful clinical trials using bioethically-sound pioneering biotechnology such as these gene therapies?

Cancer therapy by shotgun
We probably think that cancer treatments involve precision chemotherapy and accurate radiotherapy.  And, by and large, such approaches work.  However, there is a new, rather bullish, approach that is gaining traction.  It involves blasting patient’s cancer cells with dozens of drugs simultaneously in the hope of finding one that works.  Such shotgun therapy is generally frowned upon by the medical fraternity.  But read on.

Take the case of Kevin Sander, a 38-year-old procurement manager living in Austria.  His blood cancer had returned and his treatment options were running out.  He really needed a stem-cell transplant, but the uncontrollable extent of his tumour precluded that.

So, in 2022, Sander went rogue and joined a landmark clinical trial led by haematologist Philipp Staber at the Medical University of Vienna.  The study is exploring an innovative treatment strategy in which drugs are tested on the patient’s own cancer cells, cultured outside the body.  The research team tried 130 compounds on cells grown from Sander’s cancer – essentially, they were trying everything at their disposal to see what might succeed.

One option looked promising.  It was a type of kinase inhibitor that is approved to treat thyroid cancer, but is seldom, if ever, used for the rare subtype of lymphoma that Sander had.  He was prescribed a treatment regimen that included the drug, and it worked.  The cancer receded, enabling him to undergo the stem-cell transplant.  He has been in remission ever since.  He has declared, ‘I’m a bit more free now.  I do not fear death anymore.  I try to enjoy my life.’

Kevin Sander’s story is an example of this kind of intensive and highly personalised drug-screening method – it is called ‘functional precision medicine’.  It aims to match treatments to patients, but instead of relying on a genomic-based approach with best-matched treatment, it throws the lab’s reagents at the cancer cells and sees what sticks.  It may be inelegant, but it may work.  Staber’s team reports that more than 50% of blood cancer patients on the shotgun regime enjoy longer periods of remission than those on standard treatments, where the proportion is a mere 10%.

The protocol is deceptively simple.  Cells from cancer biopsies are dispersed using a knife, forceps and a nylon strainer.  The resulting slurry is distributed across a 384-well plate.  In each well is a different drug compound – chemotherapy agents, enzyme-targeted drugs, immune-modulating therapies and more.  After a night of incubation, lab testing reveals which drugs are active against the particular cancer and which are not.

A growing number of groups are reporting success with this general approach.  For example, in a trial conducted at the University of Helsinki, researchers found that drug screening of leukaemia cells provided informative results substantially faster than did genomic profiling.  Moreover, of 29 people with treatment-resistant acute myeloid leukaemia (AML), 17 responded to drug-screening-informed therapies and entered remission.

Yet this is only the beginning.  At least anecdotally, the try-everything approach can be exciting and effective, but there are problems ahead.  For example, screening a bunch of drugs may seem simple, but the methods used to culture cancer cells outside the body can be technically demanding, time-consuming and costly.  Replicating the in vivo environments for culturing cancers, especially for solid tumours, is complicated.

The world of oncology awaits the results of Staber’s latest trial in which he and his team compare functional- and genome-guided approaches directly alongside treatments suggested by standard pathology and physician intuition.  Proponents of functional precision medicine have called it a revolution.  We shall see.

Move over CRISPR-Cas9
The CRISPR-Cas9 gene-editing system excels at altering and disrupting genes.  In many ways it has transformed experimental biology and specifically, treatments of diseases.  However, the changes it makes can be limited in terms of safety, efficacy and scope.  Moreover, its edits of DNA are permanent, which can be a serious problem if the system goes awry and introduces, for example, unwanted off-target, or incomplete, editing.

Such engineered CRISPR systems typically consist of two main components – a DNA-cutting enzyme, often Cas9, and a piece of ‘guide’ RNA that directs the enzyme to the stretch of DNA to be edited.  One of this system’s most promising medical applications has been in producing chimeric antigen receptor (CAR) T cells.  These are made by engineering the immune system’s T cells to attack specific proteins on the surfaces of tumour cells.  But such DNA-editing CRISPR systems can pose safety problems and are relatively inefficient.

Enter a new CRISPR-based system that targets a cell’s short-lived messenger RNA rather than its DNA.  This could provide a more precise and reversible way of designing cell therapies.

This new genetic engineering tool has been described in an article entitled, ‘A versatile CRISPR-Cas13d platform for multiplexed transcriptomic regulation and metabolic engineering in primary human T cells’ by Victor Tieu et al, and published in Cell (2024, 187: 1278-1295).

This team from Stanford University has developed what they call multiplexed effector guide arrays (MEGA), a platform for programmable and scalable regulation of the T cell transcriptome using the RNA-guided, RNA-targeting activity of CRISPR-Cas13d rather than the DNA-cutting enzyme, Cas9.

And because Cas13d targets mRNA it avoids the risk of inducing permanent changes or, worse, cutting DNA in places other than the designated target.  In addition, because the RNA exists only temporarily in the cell, any mistakes should quickly disappear.

Active cells, such as T cells, produce a constantly changing variety of mRNA molecules, each directing the production of a specific protein.  Cas13d cuts the target mRNA, destroying it and preventing it from synthesising a specific protein.  In other words, it is similar to turning off the associated gene.  MEGA goes further by allowing researchers to create ‘multiplex’ CRISPR–Cas13d systems that can shut down the production of multiple proteins, effectively turning off as many as ten genes at a time.

The Stanford team tested the MEGA system by addressing a shortcoming of CAR T therapy called T-cell exhaustion.  If CAR T cells are activated too many times by a chronic infection or a long-term tumour, they become less effective.  To reboot ‘tired’ T cells, the researchers designed CRISPR systems that target mRNA involved in functions such as energy production and sugar metabolism.  Some MEGA-treated T cells were revitalised and stopped expressing molecular signals of exhaustion and became better at shrinking tumours in mice.

So, now it’s from mice to men (and women).  Bring on the next generation of T-cell therapies.  Bring on the human clinical trials.  Sometimes good science can make you feel quite giddy.

Stem-cell Technology

Stem cells and glioblastoma
A rather exciting form of immun
otherapy derived from induced pluripotent stem cells (iPSCs) has been shown to be effective in treating brain cancer – OK, so far, only in mice, but still exciting.

Glioblastoma (GBM) is an aggressive brain cancer with a poor prognosis.  Glioblastomas are almost always lethal with a median survival time of 14 months.  Conventional treatments, such as surgery, chemotherapy and immunotherapy, have not produced significant extensions of life-expectancy as seen for many other cancers.  This resistance to treatment is partly due to the cancer's ability to evade and suppress the body's natural immune response.  Researchers have now genetically engineered immune cells derived from stem cells and designed them to target and dismantle the immune suppressive tactics employed by the tumour, meaning they can destroy the cancer cells.

This work has been reported as ‘synNotch-programmed iPSC-derived NK cells usurp TIGIT and CD73 activities for glioblastoma therapy’ by Kyle Lupo et al., and published in Nature Communications (2024, 15: 1909).

In their study, these researchers at Purdue University did not use traditional ‘personalised’, autologous stem-cell therapies that require cells to be collected and returned to the same patient.  Instead, they employed 'off-the-shelf' stem cells to generate natural killer (NK) cells, namely immune cells known for their ability to identify and attack cancer cells.  In other words, they engineered allogeneic induced pluripotent stem cell (iPSC)-derived NK (iNK) cells.  These readily-available cells eliminate the need for additional collection procedures, which could be a significant advantage, considering the time-sensitive nature of brain cancer treatments.

The team directly injected these iNK cells into mice bearing human brain cancer tumours.  The outcomes were promising, significantly improving survival times and reducing tumour size.  The next step is to develop further this glioblastoma protocol and to begin conducting clinical trials to treat human patients with brain tumours, including those for whom surgery has not been successful.

According to Sandro Matosevic, associate professor at Purdue University, Indiana, and lead researcher in this study, 'Our preclinical studies showed these immune cells to be particularly remarkable in targeting and completely eliminating the growth of the tumours.’  And, ‘We found that we can engineer these cells at doses suitable for clinical use in humans.  This is significant because one of the major hurdles to clinical translation of cell-based therapies to humans has been the poor expansion and lack of potency of cells that were sourced directly from patients.  Using an off-the-shelf, fully synthetic approach breaks down significant barriers to the manufacturing of these cells.'  And, ‘Our ultimate goal is to bring this therapy to patients with brain tumours.'  And, ‘These patients urgently deserve better and more effective treatment options.  We believe there is true potential for this therapy, and we have the motivation and capacity to bring it to the clinic.’

Human stem cell-based embryo models
On 28 February 2024, the UK Government published a so-called POSTnote with the above title.  It summarises the emerging technology of human stem cell-based embryo models (SCBEMs).  The 25-page document is available online at https://researchbriefings.files.parliament.uk/documents/POST-PN-0716/POST-PN-0716.pdf (cut and paste if necessary).

This useful, but not necessarily bioethically sound, document contains a summary of six Key Points.  They are:

1]  Human SCBEMs are created from pluripotent stem cells, these cells are unspecialised and have the ability to develop into other cell types.

2]  Human SCBEMs offer the opportunity to study and explore the key features and processes of the early development of embryos in ways we cannot with human embryos.

3]  The terminology describing SCBEMs can vary, they have been referred to as artificial embryos, synthetic embryos, stembryos, synthetic human entities with embryo-like features (SHEEFs), embryo-like structures (ELS), embryo models and embryoids.

4]  Internationally, legal definitions and regulations around human SCBEMs vary from no explicit regulation to different limits on its research.

5]  The International Society for Stem Cell Research have created guidelines to address the international diversity of cultural, political, legal and ethical issues around the emerging technology and its application in medicine and treatments.

6]  Stakeholder suggestions towards effective oversight of SCBEMs include (i) identifying similarities and differences between SCBEMs and human embryos, (ii) an independent oversight process involving experts and lay members, and (iii) conducting public engagement to increase public understanding and identifying concerns surrounding the technology.

The entire POSTnote, including these six Key Points, contain controversial statements.  Indeed, for decades the use of human embryos in both research and reproduction has been bioethically calamitous.  And now human stem cell-based embryo models (SCBEMs) are similarly riddled with bioethical dilemmas.  Nevertheless, to keep abreast of emerging technologies it is necessary to understand topics, the use of which will be opposed by many readers.

Stem cells and spinal cord injuries
Spinal cord injuries (SCIs) are debilitating conditions that carry severe medical, psychological and financial implications for those living with such impairments.  Existing treatments are limited to symptomatic management and physical rehabilitation.  Some sort of stem-cell regenerative medicine would be welcome.

Adipose tissue represents the most prominent reservoir of mesenchymal stem cells, known as adipose-derived mesenchymal stem cells (AD-MSCs).  These cells are considered attractive options due to their availability, ease of access, and multipotency.  In addition, preclinical trials in animals with SCIs demonstrated that AD-MSCs can regulate the inflammatory response and promote a regenerative environment with promising clinical outcomes.

A recent Phase 1 study, conducted at the Mayo Clinic in Rochester, Minnesota, has shown that treatment with AD-MSCs, derived from a patient’s own adipose tissue, can be safe and can improve sensation and movement after traumatic spinal cord injuries.

The findings from this clinical trial have been reported as ‘Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial’ by Mohamad Bydon et al., and published in Nature Communications (2024, 15: 2201).

The ten participants enrolled in this trial had SCIs from motor vehicle accidents, falls and other causes.  Six had neck injuries and four had back injuries.  The patients ranged in age from 18 to 65.

Participants' AD-MSCs were harvested by extracting approximately 15ml of adipose tissue from a 1 to 2-inch incision in the abdomen or thigh.  Over the next four weeks, the cells were cultured in the laboratory to the required dosage of about 100 million.  These were then injected into the patients' lumbar spine in the lower back.  During the following two years, each participant was evaluated ten times at the Mayo Clinic.

Each patient was examined and graded according to the American Spinal Injury Association Impairment Scale (AIS).  At the time of injury, eight patients were classified as AIS grade A and two patients as AIS grade B.  At the time of stem-cell injection, five patients were classified as AIS grade A, two as AIS B, and three as AIS C.

At the final follow-up, seven patients displayed improvements in their AIS grades from the time of injection.  These improvements included motor and sensory functions, such as increased sensation when tested with pinprick and light touch, increased strength in muscle motor groups, and recovery of voluntary anal contraction, which aids in bowel function.  Of the seven participants who improved, each moved up at least one level on the ASI scale.  The three patients who showed no response, did not improve, but neither did they decline.

The study met its primary endpoint, namely demonstrating that AD-MSC harvesting and administration were well tolerated in patients with traumatic SCIs.  The most commonly reported adverse events were headache and musculoskeletal pain, observed in 8 patients.  No serious adverse events were observed.

In addition to evaluating its safety, this Phase 1 clinical trial had a secondary objective of assessing changes in motor and sensory function.  The authors noted that though these results were mostly positive they must be interpreted with caution given the intrinsic limitations of Phase 1 trials.  Additional research with a larger group of participants is needed to further assess risks and benefits.

According to Mohamad Bydon, a Mayo Clinic neurosurgeon and first-named author of the study, has commented, ‘Spinal cord injury is a complex condition.  This study documents the safety and potential benefit of stem cells and regenerative medicine.  Future research may show whether stem cells in combination with other therapies could be part of a new paradigm of treatment to improve outcomes for patients.’


Terminalism – discrimination against the dying
Bioethics, indeed, life in general, is contaminated with -isms.  In terms of discrimination there are the deep-rooted examples of racism, sexism and classism.  Then there are the more modern cases of speciesism, ableism and ageism.  And finally, there are the newbies of nimbyism, transgenderism and terminalism.  What was that last one?  It is nothing to do with missed buses or trains.  The philosopher Philip Reed is the culprit and the proponent.

In an article under the title, ‘Discrimination against the dying’ and published in the Journal of Medical Ethics (2024, 50: 108-114), Dr Philip Reed of Canisius College, Buffalo, New York, makes his case.  He defines terminalism as ‘discrimination against the dying, or treating the terminally ill worse than they would expect to be treated if they were not dying.’

Furthermore, Reed asserts that terminalism goes largely unrecognised, especially in healthcare settings.  He provided four examples – hospice eligibility requirements, allocation protocols for scarce medical resources, right to try laws, and right to die laws.

Inevitably, the issues of euthanasia and assisted suicide are also sculking around nearby.  Are, for example, people who want to die being discriminated against because of existing legislation?  Reed answers, ‘In denying that the terminally ill are committing suicide by accessing assisted death, the professional organisation most committed to preventing suicide has given up its responsibility of addressing suicidal ideation among the terminally ill.  This is terminalist: purely on the basis of group membership, one group gets suicide prevention and another gets suicide assistance.’

He continues, ‘Moreover, the availability of the option of assisted death only for the terminally ill negatively influences the terminally ill who wish to live by causing them to doubt their choice.  When assisted death is available only to the dying, a dying person may be prone to feel a need to justify his existence in a way that the non-dying, not having the option, need not do.  This puts the dying at a disadvantage.’

Reed has other arguments to make.  For instance, he states that, ‘… discrimination against the dying occurs regularly in high-capitalist Western cultures.  I think terminalism is relatively easy to see, that it has been hiding in plain sight, and the fact that we have not yet confronted it reveals in part our blind spots and prejudices.  We don’t want to think of ourselves as discriminating against yet another vulnerable group, yet we are plainly doing so.’

Reed concludes his searching article, ’The reason that terminalism matters is that dying persons matter.  Our willingness to treat such patients badly assumes a kind of fatalism – where we imagine that a life with very little future means a less valuable life.  Of course, there is nothing new in pointing out that the terminally ill deserve better.  Certainly, the plight of the dying and material attempts to improve it have a long history.  Yet the fact that they are subject to discrimination, as I have argued in this paper, shows a special kind of mistreatment that they suffer.  It is a matter of unfairness or harm or both that the dying withstand disadvantageous treatment merely on account of their group membership.  Confronting terminalism forces us to ask an uncomfortable question: what do we owe the dying and how might we treat them as equals with those who have indefinitely long to live?’

This is just over 6 pages of thought-provoking stuff.  Philip Reed is professor of philosophy at Canisius University, a Jesuit-affiliated institution.  Its motto is cura personalis – care for the whole person.

The asymmetric start of life
You already know the bioethical biologist’s refrain.  When sperm plus ovum unite, a single cell is produced.  It is a zygote.  It is a sort of 1 + 1 = 1.  This zygote is a new, genetically-unique human life, etc., etc.  Then, within some 24 hours, the 1-celled zygote divides to become a 2-celled blastomere.  The marvels of cell division are about to take off, big time – it is 2, 4, 8, 16, and so on.  Meanwhile, the process of cell differentiation switches on allowing these totipotent embryonic stem cells to become specialised cells, such as liver, hair, toenails, and so forth.

Cell differentiation obviously results in cells that are no longer identical.  However, the zygote and the blastomeres, the first two cells of the first cell division, have long been thought to be identical totipotent cells.  Surprisingly, this now seems unlikely.  Our current understanding of the development of human biological symmetry is not quite right – it needs amending.

This is the conclusion of a research paper entitled, ‘The first two blastomeres contribute unequally to the human embryo’ by Sergi Junyent and colleagues and published online in Cell (13 May 2024).  The authors include members of the team led by Professor Magdalena Zernicka-Goetz from the Department of Physiology, Development and Neuroscience at the University of Cambridge.

To understand this process better, Zernicka-Goetz and her collaborators first tracked cell lineage from the two-cell stage.  They injected mRNA for green fluorescent protein (GFP) into one of the two cells of the zygote.  Thus, they could determine the contribution of each cell to the development of two early structures – the trophectoderm (TE) that becomes the placenta and the inner cell mass (ICM) that eventually produces the epiblast, or foetal tissue, and the hypoblast, or the yolk sac.

By tracking their subsequent development, they found that one population of cells dominated in either the ICM or the TE, but that this imbalance was greatest in the ICM.  Within the ICM, progeny from one clone at the two-cell stage dominated the population of the epiblast, while the composition of the hypoblast was split between cells of the two originating clones.

Put another way, they found that when a human embryo is one day old and comprises just two cells, only one cell will create most of the foetus in addition to placenta, while the other cell will create placenta.  In other words, the first two blastomeres contribute unequally to the human embryo.  According to Zernicka-Goetz, ‘They are not identical.  Only one of the two cells is truly totipotent, meaning it can give rise to body and placenta, and the second cell gives rise mainly to placenta.’  This means, we all started our early lives asymmetrically.

This challenges the previous notion that each cell at the 2-cell stage contributes equally to all parts of the developing embryo and placenta, and it suggests that embryo asymmetry occurs much earlier than previously believed.  Those first two cells are not equivalent – there is imbalance early on because each cell of the blastomere do not give rise to half of all the cells in our bodies.

This is intriguing biological stuff.  Moreover, there are some interesting political and economic undercurrents in this research paper – it is not all about science.  For instance, the authors state, ‘The reason behind this imbalance is not known.  Indeed, when and how cell fate decisions are initiated in the human embryo remain long-standing questions, because the access to human embryos for research is extremely limited.’  This is an indirect plea for the Human Fertilisation and Embryology Authority (HFEA) to press for a loosening of the law restricting destructive embryo experimentation and for easier access to more and later-developed human embryos.

The authors then pitch their puff for future funding!  Their Departmental article (published on 15 May) states, ‘It is hoped that these findings will improve the success rates of IVF pregnancies through a deeper understanding of early embryo development and increase knowledge of the origins and developmental contributions of cell lineages, which has implications for the cellular inheritance of mutations and how they might contribute to cancer and other genetically determined disease.’  Come on, who could be against improving IVF successes and cancer cures?  In plain English,
give us a large grant, please!

In summary, this is fascinating, cutting-edge human biology.  We know so little.  However, there is a cost to gaining such knowledge.  Undergirding all this sort of research is the fact that it depends upon a steady supply of human embryos, and these are inevitably destroyed.  Indeed, for this current work, Zernicka-Goetz relied on an IVF clinic that could provide her laboratory with 54 fertilised eggs, zygotes that had not yet fully completed their first cell division.  Eventually they were trashed.

Right- or left-handed?
For what it’s worth, I’m sinister, along with about 10% of the world’s population.  However, this is not strict demographic arithmetic – unexplained statistical blips occur.  For example, since WWII there have been fourteen different US Presidents and six, or a hefty 43%, of them have been left-handed.  But that is another story.  I can also roll my tongue along with about 65% of the population, but that too is another story.  And I can do other party tricks, but this is not the place to brag of my biological feats.

So, what makes us handed?  Handedness is linked to brain asymmetry, as right-handedness reflects left-hemisphere dominance for control of the preferred hand, and vice versa.  But how did this handedness start?  There will have been both physical components and social pressures.  But before those became significant there must have been a biological element.

Handedness has long been a fascination and its associated literature could already fill several library shelves.  Here is one of the latest contributory ideas.  Your handedness may have been decided by the protein content in you as an early embryo, yes, in little embryonic you!  At least that is the gist of an article entitled, ‘Right- or left-handed?  Protein in embryo cells might help decide’ by Sumeet Kulkarni and published in Nature (2 April 2024).

Take a biological step back from this issue of protein content and we are faced with the fact that its drivers will have been the genes that coded for those structural proteins.  In other words, genes could have determined the dominant side of the human brain, and yes, your brain too, and thus also your handedness.

During the embryonic stage of human development, the left and right brain hemispheres get wired differently, which in part determines our innate behaviours, such as which way we lean when we hug someone, on which side of our mouth we tend to chew our food and, most prominently, which hand is our dominant one.  And because most people have a clear preference for one hand over the other, finding genes linked to handedness can provide clues for the genetic basis of the brain’s left–right asymmetry.

Isn’t this fascinating?  An earlier study by Gabriel Cuellar-Partida et al., and entitled, ‘Genome-wide association study identifies 48 common genetic variants associated with handedness’ and published in Nature Human Behaviour (2022, 5: 59-70) found that these variants were associated with left-handedness.  They were mostly located in non-coding regions of the DNA including sections that could control the expression of genes related to tubulins.  Tubulins are proteins that polymerise into long, tube-like filaments called microtubules, which can oversee the shapes and movements of cells.

Kulkarni majors on the work of Dick Schijven and colleagues from the Max Planck Institute for Psycholinguistics, in Nijmegen, the Netherlands.  In particular, he cites their recent article entitled, ‘Exome-wide analysis implicates rare protein-altering variants in human handedness’ published in Nature Communications (2024, 15: 2632).

Schijven and his collaborators, looked for rare genetic variants in protein-coding sequences.  They analysed the genetic data of 313,271 right-handed and 38,043 left-handed individuals as recorded in the UK Biobank database.  Their findings also implicated tubulins, those structural proteins that build the internal skeletons of cells.  Furthermore, they discovered variants in a tubulin gene, dubbed TUBB4B, which were 2.7 times more common in left-handed people than in right-handers.

According to Clyde Francks, senior author of the Nature Communications paper, these rare variants, ‘can give clues to developmental mechanisms of brain asymmetry in everyone.’  In addition, he maintains that these findings pave the way for future work to determine how microtubules, which themselves have a molecular ‘handedness’, can give an ‘asymmetric twist’ to early brain development.

Perhaps microtubules influence handedness because they form cilia – hair-like protrusions in cell membranes, which can direct fluid flows in an asymmetric way during development.

Wonderful and beguiling!  Ponder it next time you seemingly unconsciously decide with which hand to throw that ball.

USA and Elsewhere

A frozen embryo is a …..?
The USA and the UK do things differently.  In legal matters, the USA relies on its Supreme Court, whereas the UK trusts its Parliament.  Think of abortion and its legalisation.  In 1973, it was the Supreme Court that handed down its verdict in the Roe v. Wade case.  The UK’s 1967 Abortion Act was a Parliamentary affair.  The former was based on the Constitutional concepts of liberty and privacy, while the latter focussed on the physical and mental health risks to women.  Different procedures, yet similar outcomes – both were landmark decisions, both permitted widespread abortion across both countries.

It took another 50 years before the perceived ‘right to abortion’ in the USA was successfully challenged.  Again, it was the Supreme Court that ruled in the Mississippi case of Dobbs v. Jackson Women's Health Organization in June 2022.  It declared that there was no Constitutional protection for abortion.  Roe v. Wade was therefore overturned.  The upshot was massive.  Federal abortion law was returned to be determined by individual states and many implemented bans or restrictions on abortion access.

In February 2024, a third landmark bioethical case, that of LePage v. Mobile Infirmary Clinic, Inc., was decided.  The Supreme Court of Alabama ruled that, under state law, frozen human embryos are children.

The case arose from a wrongful death lawsuit brought by three couples involving the loss of their frozen embryos at the IVF clinic of Mobile Infirmary, Inc.’s Center for Reproductive Medicine.  The plaintiffs were James and Emily LePage, Felicia and Scott Aysenne together with William Tripp and Caroline Fonde.

The couples had undergone IVF treatment, resulting in the creation of several embryos.  Some were transferred to the women and some were stored in the clinic’s cryopreservation facility for possible future use.  However, in 2020, those frozen embryos were destroyed when a patient from a nearby hospital wandered into the Center, tampered with an unsecured freezer, resulting in the embryos being dropped on the floor.

The couples sued under Alabama's 1872 Wrongful Death of a Minor Act, a statute that allows parents of a deceased child to recover punitive damages for their child’s death.  They sought damages for wrongful death, negligence, wantonness plus mental anguish and emotional distress.

In 2022, the Alabama trial court dismissed the plaintiffs’ claims.  It held that the embryos did not meet the definition of a ‘child’ under the 1872 Act, therefore their loss could not give rise to a wrongful-death claim.

However, in February 2024, on appeal, the Supreme Court of Alabama disagreed and reversed the lower court’s decision.  Alabama’s Supreme Court summarised its 25-page ruling in the following terms, ‘The central question … is whether the Act contains an unwritten exception to that rule for extrauterine children – that is, unborn children who are located outside of a biological uterus at the time they are killed.  Under existing black-letter law, the answer to that question is no: the Wrongful Death of a Minor Act applies to all unborn children, regardless of their location.’

Furthermore, it stated that, ‘The statutory term “child” in the Act includes an “unborn child”, and it held ‘that nothing in the Act creates an exception for “unborn children” who are not physically located in utero … at the time they are killed.’  In other words, ‘The relevant statutory text is clear: the Wrongful Death of a Minor Act applies on its face to all unborn children, without limitation.’  ‘“Unborn children” are “children” under the Act, without exception based on developmental stage, physical location, or any other ancillary characteristics.’

In his concurring opinion, Chief Justice Tom Parker drew attention to Alabama's Constitution, which declares a state policy to ‘recognize and support the sanctity of unborn life.’  He held that, ‘Human life cannot be wrongfully destroyed without incurring the wrath of a holy God, who views the destruction of His image as an affront to Himself.  Even before birth, all human beings bear the image of God, and their lives cannot be destroyed without effacing his glory.’

The Court’s assertions sent shockwaves among the providers of IVF and other assisted reproductive technologies (ARTs), across the USA and beyond.  According to media reports, several IVF clinics in Alabama and elsewhere paused or abandoned treatments.  In addition, public figures and advocacy groups were quick to respond.  For example, in a statement, the Alabama division of the ACLU (American Civil Liberties Union) not unsurprisingly insisted that, ‘The Alabama Supreme Court has grossly overstepped its role by classifying frozen embryos, single-celled fertilized eggs, as children’ and, ‘This ruling has terrifying implications for people in Alabama.’

In the Court's only dissenting opinion, Justice Greg Cook warned the ruling would ‘almost certainly’ end the creation of frozen embryos in Alabama, and he urged state legislators to consider the matter.  However, the Alabama Attorney General, Steve Marshall, confirmed that he has no intention of using the recent Alabama Supreme Court decision as a basis for prosecuting IVF families or providers.

The legal impact of this IVF decision is probably limited to Alabama and legal experts consider it is unlikely to be appealed to a higher court, given that it dealt with a question of Alabama state law.  Indeed, on Friday 3 May, the Alabama Supreme Court declined to reconsider its controversial ruling.  Justices, in a 7 to 2 decision, without comment, rejected a request to revisit its decision.

So, will IVF be banned, limited or ignored?  Some IVF advocates have nebulously contended that the way forward with IVF is to respect ‘the special moral status of the embryo in an appropriate manner’ – whatever that claptrap means.  Others, such as Senators Ted Cruz of Texas and Katie Britt of Alabama, have gone to law and introduced a bill called the IVF Protection Act that seeks to ensure that no state prohibits access to IVF services.

A first practical step is obvious.  Forbid the creation of surplus embryos and their cryogenic storage.  The German 1990 Embryo Protection Act already requires this and it also prohibits the fertilisation of more ova than will be transferred in one IVF cycle.  A second step is to store only unfertilised ova.  A third step is to ban IVF outright.  While that may not be feasible, the bioethical mantra still stands – IVF is best avoided.

Abortion in Florida
This is now post-Roe America and already many states have decreed their own abortion rules.  On 1 May 2024, a new abortion law came into effect in the Sunshine State.  It generally prohibits abortions after six weeks.  Somewhat strangely, a month before, on 1 April 2024, Florida's Supreme Court delivered two rulings on abortion with competing consequences.

First, the Court upheld the state's right to ban abortion, giving the green light for the six-week bar to take effect from 1 May.  This near-total ban blocks almost all abortion access in the US South.  Florida had been something of a haven for those seeking abortions, because it is surrounded by states that had already implemented six-week or total bans.

Florida is perhaps the key battleground of the abortion battle.  It is the USA’s third most populous state and the ban may affect more women than any other statewide veto since the repeal of Roe.  According to the Guttmacher Institute, the pro-abortion research group, just over 84,000 women had abortions in Florida in 2023.

The new ruling has been applauded by national pro-life activists, many of whom see a six-week ban as the gold standard for abortion policy.  According to Katie Daniel, Florida’s policy director of the Susan B Anthony Pro-Life America organisation, the decision was 'a victory for unborn children.'

On the other hand, pro-abortion advocates maintain that Florida's six-week law is particularly restrictive, requiring patients seeking abortions to have two in-person doctor appointments, with a 24-hour cooling-off period in between.  Anna Hochkammer, executive director of the pro-choice group Florida Women's Freedom Coalition has said, ‘At six weeks most women have no idea that they're even pregnant.  A mammoth health crisis is about to befall us.’

In the second Florida Supreme Court ruling, announced on 1 April, and by a 4-3 vote, the Justices approved a November ballot initiative that, if approved by Florida’s voters, would overturn the six-week ban and enshrine broad abortion access within the state's Constitution.  What a mess!

November 2024 is warming up to be a politically hot month for abortion.  Besides the Florida initiative, there is the matter of the 60th quadrennial Presidential election on Tuesday 5 November.  Between now and then, political uncertainty will abound, but certainty declares that abortion will be an intense, even incendiary, issue during the campaign and afterwards.  Inter alia, we should also find out what Biden and Trump really think about abortion.

Irish politics
If politics can be erratic, Irish politics can be eldritch (look it up).  On Saturday 9 March 2024, the Irish Government announced the results of two referenda held the day before.

The Irish electorate had been faced with a proposal to alter the wording of the Constitution to include families that are not based on marriage.  It was defeated with 67.7% voting 'No'.  A second proposal was to change the wording around the role of women in the home – it was rejected by an even greater margin of 73.9%.

Taoiseach Leo Varadkar (the Irish prime minister) said it was clear that both amendments had been ‘defeated comprehensively on a respectable turnout.’

Here is the Republic’s nitty-gritty ethical paradox.  These results demonstrate the apparent Irish intransigence to progressive politicking.  It sounds like conservative Roman Catholic dogma.  And yet, these are the very same people, who in May 2018, overturned the age-old Irish ban on abortion, by repealing the Eighth Amendment of the country’s’ Constitution.  The new law came into effect on 20 December 2018 meaning that abortion was permitted in the first 12 weeks of pregnancy and in later cases where the woman’s life or health is at risk, or in cases of fatal foetal abnormality.  Those are typically orthodox conditions of European abortion law.  It sounds most unlike conservative Roman Catholic dogma.

The Irish are a complex race, but they love a good referendum.  In May 2015, the Republic voted overwhelmingly to legalise same-sex marriage in an historic referendum.  More than 62% voted in favour of amending the country's Constitution to allow gay and lesbian couples to marry.  It was the first country in the world to legalise same-sex marriage through a popular vote.

All this begs a fundamental question – do the Irish have some sort of split moral personality?  It’s very eldritch.

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