Update on Life Issues - October 2023


Is abortion in England and Wales a crime?
Yes, according to Sections 58 and 59 of the 1861 Offences Against the Person Act, it surely is.  The 1967 Abortion Act simply protected from prosecution a ‘registered medical practitioner’ who performed an abortion as long as two such doctors certified that in their opinion, formed in good faith, the continuance of the pregnancy would involve risk, on one or more of six grounds, greater than if the pregnancy were terminated.

Of course, protected by the 1967 Act, UK doctors are performing tens of thousands of abortions in the UK every year.  And every now and again, someone is prosecuted under the 1861 Act.  In fact, it is thought that only three such prosecutions have been brought in England and Wales during the last 160 years.  Now in 2023 that number has suddenly risen by five more.

In December 2022, the Crown Prosecution Service (CPS) dropped the case against a 25-year-old Oxford mother who was charged with taking misoprostol to procure her own miscarriage while 31 weeks pregnant.  The woman was charged a year after her baby was successfully delivered by C-section in January 2021.  The CPS considered that prosecuting her under the 1861 Act would not be in the public interest.  The judge said he was ‘flabbergasted’ that she was ever being prosecuted.

In June 2023, Carla Foster, 45, was convicted and sentenced to 28 months imprisonment by Stoke Crown Court.  She had admitted inducing a miscarriage during the first Covid-19 lockdown, when she was 32 to 34 weeks pregnant.  At the Court of Appeal, her sentence was cut to 14 months suspended, and she was released from prison.

In August 2023, Bethany Cox, 22, appeared at Teesside Crown Court accused of carrying out an illegal abortion in July 2020.  She pleaded not guilty to charges of child destruction and unlawfully administering poison or another noxious substance with intent to procure her own miscarriage and is due to stand trial in early 2024.

Sophie Harvey, 23, is due to stand trial in November at Gloucester Crown Court, with her partner Elliot Benham, also 23.  They have pleaded not guilty to joint charges that include illegally procuring drugs from India to procure a miscarriage and concealing the birth of a child.  Harvey has also been charged with inducing her own miscarriage.

In September 2023, a woman, who cannot be named for legal reasons, appeared in court accused of procuring ‘poison’ – the abortion drugs mifepristone and misoprostol – with intent to cause her own miscarriage.  The offence, under Section 58 of the 1861 Offences Against the Person Act, is alleged to have been committed in November 2020, during the second Covid-19 lockdown.

These five cases, mostly related to the ‘pills by post’ or ‘DIY abortion’ scandal, suggest that prosecutors are taking a much more aggressive stand against women with unexplained pregnancy loss, or who are suspected of having an illegal abortion.  What’s wrong with that?  The general public is frequently asking for our laws to be upheld properly.  And what is wrong with a law that is 162 years old?  Pro-abortion campaigners are calling for the repeal of the 1861 Offences Against the Person Act and the decriminalisation of abortion.  They recently wrote to Max Hill KC, the director of public prosecutions (DPP) calling for, ’urgent guidance to stop the prosecution of women who end their own pregnancies, with immediate effect.’

The battle for the lives of unborn children (and their mothers) continues.  Abortion should never be permitted in a compassionate, civilised society.  What has changed in 162 years?  The 1861 Act protected the unborn child – the 1967 Act fails to protect the unborn child.

Mexico decriminalises abortion
Back in 2021, a Mexican Court ruled in favour of a challenge to the existing abortion law in the northern state of Coahuila.  It ruled that criminal penalties for terminating pregnancies were unconstitutional.  This new law set the abortion juggernaut rolling.

Then in September 2023, the Supreme Court said that denying the opportunity of a termination violated the human rights of women.  Abortion was therefore decriminalised across all 32 Mexican states.  The head of the Supreme Court, Arturo Zaldívar stated that, ‘In cases of rape, no girl can be forced to become a mother – neither by the state nor by her parents nor her guardians.  Here, the violation of her rights is more serious, not only because of her status as a victim, but also because of her age, which makes it necessary to analyse the issue from the perspective of the best interests of minors.’

Mexico City was the first of the country's states to decriminalise abortion in 2007 and a dozen others followed suit.  Now this new judgement opens the door for the entire federal healthcare system to provide abortions.  Despite the lack of abortion facilities, many have welcomed the move.  For example, women's rights activist Sara Lovera is reported as saying, ‘Many women don't know that they have this right because local governments have not carried out publicity campaigns about it.  That's why today's decision of the Supreme Court is important.’

Not all are happy.  The new ruling is likely to anger Mexico's more conservative politicians and the Roman Catholic Church, in what is Latin America's second largest Catholic nation.  However, the Church's influence has been declining in recent years and the country's government considers itself staunchly secular.

Latin America has seen a trend towards loosening abortion restrictions that has been referred to as a ‘green wave’.  Elective abortion is legal in Colombia, Cuba, Uruguay and Argentina, though the frontrunner in the campaign for Argentina's presidential election in October, Javier Milei, wants to ban the procedure.  Some other Latin American countries allow abortions in circumstances such as rape or health risks, while outright bans apply in El Salvador, Honduras, Nicaragua, Haiti and the Dominican Republic.

These reforms in Mexico and other Latin American countries contrast with the situation in the United States, where a Supreme Court ruling in June 2022 overturned the landmark 1973 Roe v. Wade decision which had previously granted the right to abortion nationwide.

Retraction row over abortion paper
The British Journal of Psychiatry has been widely criticised over its decision not to retract a research paper on abortion.  It has been referenced in US legal cases to restrict access to the procedure.  Three of the Journal’s international board members have resigned after the Journal and its owner, the Royal College of Psychiatrists, ignored the advice of its own internal panel to retract the paper.

The paper in question was published in 2011 by Priscilla K Coleman, who was a professor of human development and family studies at Bowling Green State University, Ohio, between August 2002 and June 2022.  Coleman has testified in at least 20 abortion-related cases, all in favour of greater restrictions on the procedure and the paper was cited in recent US legal cases that restricted access to abortion and mifepristone, a drug used for medical abortion.

The paper is entitled, ‘Abortion and mental health: quantitative synthesis and analysis of research published 1995-2009’ by P K Coleman and published in the British Journal of Psychiatry (2011, 199: 180-186).  This is what Coleman’s distressing results revealed, ‘Women who had undergone an abortion experienced an 81% increased risk of mental health problems, and nearly 10% of the incidence of mental health problems was shown to be attributable to abortion.’  Moreover, in the Discussion section of her paper, Coleman, states, ‘The finding that abortion is associated with significantly higher risks of mental health problems compared with carrying a pregnancy to term is consistent with literature demonstrating protective effects of pregnancy delivered relative to particular mental health outcomes.’

This is hot territory.  A woman, with international research credentials, publishes her findings that abortion is a risk factor in women’s mental health.  That is dynamite for many progressive academics.

In June 2022, a group of 16 researchers led by Chelsea Polis, a senior scientist of epidemiology at the Center for Biomedical Research at the Population Council, a US-based research organisation, wrote to the British Journal of Psychiatry saying that Coleman’s paper had methodological issues that invalidated its conclusions.  Coleman disputes the methodological criticisms and says that the researchers are motivated by a desire to discredit her as a researcher and an expert witness for political reasons.

After the British Journal of Psychiatry contacted Coleman to inform her that an ‘expression of concern’ would be added to her paper, her lawyers sent the Journal a letter saying that such a notice would cause ‘serious harm and direct damage to her reputation.’  Coleman has said that most of the signatories of the retraction request letter have pro-choice views or are aligned with pro-choice or reproductive rights organisations and initiatives, whereas she has never held membership of any pro-life organisation.  She maintains that ‘It is not appropriate today for activists to call for a retraction because they are uncomfortable with the results and the study is having a major impact in terms of informing clinical practice and policy.’

A spokesperson for the Royal College of Psychiatrists stated that for various reasons, ‘It has been decided to reject the request for the article to be retracted.’  Hooray for free speech, scientific integrity and truthfulness.  The debate goes on!


Are you my Dad?
From Sunday 1 October, 18-year-olds in the United Kingdom, who were conceived with donor gametes, were able to find out the identity of their genetic donor parents.  Is this the beginning of that unexpected knock on the front door followed by the even more surprising, ‘Hello, Dad’?

The UK donor anonymity law was amended in 2005 to ensure that everyone has a right to information about their genetic origins.  This means that the records of ova, sperm or embryo donors who donated after 1 April 2005 will be available.  Moreover, it means that about 30 people who were conceived by gamete and embryo donation from donors who registered after 1 April 2005 will turn 18 in 2023, with the first celebrating their birthdays in October.  And by the end of 2030, this number will rise to 2,406 people.  The new law gives them the right to request their donor’s full name, date of birth and last known address from the Human Fertilisation and Embryology Authority (HFEA).

To raise awareness of this landmark change, the HFEA has launched its #WhoIsMyDonor campaign.  There are limitations to the scheme.  For example, will donors want to lift their previous anonymity?  Will donors bother to update their contact details with the IVF clinic they used?  Donors will be asked only for a postal address, which is quite likely to be outdated.  And about 65% of heterosexual couples never tell their children that they are donor conceived.  The scheme is currently invisible on Twitter/X, Facebook and TikTok.  Finally, the #WhoIsMyDonor campaign runs only between 19 September 2023 and 31 January 2024.

Not having information about genetic origins has been shown in a number of studies to have a significantly negative impact on donor-conceived individuals.  According to the HFEA, over 70,000 donor-conceived children have been born since 1991 and today, donor conception accounts for 1 in 6 IVF births in the UK and 1 in 170 of all UK births.  By 2030, the HFEA predicts there will be an average of one or two donor-conceived children in every English state primary school.

Is all this yet another dilemma that predictability proceeds from the troubled bioethical basis of IVF?  It is ‘making’ children versus ‘normative parenthood’.  Move away from natural conception and problems abound.  Already there are grandmothers giving birth to their grandchildren.  Children with two fathers and three mothers.  Unknown thousands of orphaned, frozen human embryos, and so on.

And what does donating ova, sperm and embryos do?  It creates beautiful, bouncing babies, of course.  But it also adds a third person into what is best conducted as a two-person relationship, namely marriage.  And it also strikes at the very structure of a society, especially the foundations of families – it deliberately produces unstable, patchwork relationships.  As ever, the warning is, stay away from IVF and its associated practices.

Artificial ova and sperm

What might be the ultimate goal of human reproductive scientists?  Perhaps it is the creation of a human being using artificial gametes – no natural ova or sperm, no sexual intercourse, no love between a man and a woman.  That all sounds pretty mechanical and bleak.  But we are moving ineluctably down that road.

Consider so-called IVG, in vitro gametogenesis, a radical offshoot of IVF.  Scientists are striving to be the pioneers, the originators to create those very ‘artificial’ ova and sperm from ordinary human somatic cells.  The route is three-fold – first, take some ordinary human skin cells (simple), second, turn them into induced pluripotent stem cells (iPSCs, possible) and third, convert them into gametes, ova and sperm (complex).  And then what?  Mix the artificial gametes and create ‘artificial human embryos’.  For now, the chain of these three transformations is unachievable.  Yet it remains for some an embryologist’s dream.  But maybe in 5 or 10 years it will be realised.  Theoretically and technically, we are on the road.  Bioethically, morally, legally and societally we are far, far away.

Think of some of the serious associated issues.  Think who ‘owns’ artificial gametes.  Think of the problems associated with straightforward IVF.  Think about artificial IVG embryos carrying dangerous genetic mutations – one simple mutation could be disastrous.  IVG would allow women of any age to conceive genetically-related children.  What would all this mean for the family?  Men and women, husbands and wives could become redundant.  There would be an unlimited supply of genetically-matched artificial human ova, sperm and embryos for anyone, everyone, at anytime.  Genetic scanning of these readily-available artificial gametes and embryos would become the norm.  Deleting the unwanted would also become the norm.  Children with particular characteristics would become part of the shopping list of prospective parents.  IVG would eventually lead to that problematic entity – the ‘designer baby’.

No room at the freezer

IVF is full of bioethical predicaments.  It is now facing a newish problem – storage space.  As the popularity of IVF increases, and while its standard protocol involves giving women drugs to induce them to superovulate, producing as many as 5 to 10 ova in a typical treatment cycle, which, after fertilisation, leads to vast numbers of supernumerary human embryos.  Yet embryologists transfer just one, or perhaps two, embryos per cycle.  What to do with the remainder?  Freeze them or destroy them?  The upshot?  Frozen human embryos are being stockpiled and storage space is at a premium.

It was in 1978 that Louise Brown became the world’s first ‘test-tube’ baby.  Now 1 in 34 babies born in the UK is an IVF-baby.  Back in 1991, when HFEA records began, there were just 4,938 embryos in cryostorage facilities in the UK.  By the mid-2000s, it was about 50,000 rising in 2021 to a record high of almost 100,000.  Today, an average of 267 newly-created embryos are frozen in liquid nitrogen at -196⁰C every day.  In other words, there are hundreds of thousands of spare human embryos out there.  And nobody knows what to do with them.  And the numbers keep on increasing.  The use of vitrification versus the old method of ‘slow freezing’ allows for a more efficient production method.  And in July 2022, the law increased the time limit for storage from 10 to 55 years.  And of course, embryos keep on being created – in 2021, a record 291,241 were created in the UK, 64% up on the 2001 figure.  And more than 1 in 3 of these is now frozen and stored.

Many couples cannot bear to think about, let alone proceed to discard/destroy their hard-won, costly embryos, even though they will never use them for a second, third or fourth child.  And so they continue to pay for storage at perhaps up to about £500 per year.  It is all physically and emotionally gruelling.

The typical freezing apparatus is hugely and inefficiently bulky – its basic design has not changed over the decades.  And so for many IVF clinics, extra space is needed.  New facilities are being built within some clinics and the use of off-site storage will partially alleviate the problem.  The other options are to donate them to others or to research – in 2021 in the UK only 185 were donated to others and 675 to research.  And charging higher storage fees might nudge more couples to discard their embryos.  Nevertheless, the real answer is to fertilise fewer ova in the first place.  And freezing ova and sperm separately might help – it is easier to discard these mere gametes rather than embryos.

Euthanasia and Assisted Suicide

One-way tickets to Dignitas
A new report, commissioned by the pro-assisted suicide organisation, Dignity in Dying (DiD), reckons that at least 632 Britons have ended their lives by travelling to Swiss ‘clinics’, such as Dignitas in Zurich.  This number has been placarded as evidence for the need of such ‘clinics’ in Britain.  But what is the source of this figure?  It is not one that I recognised.  So I phoned DiD, three times, to enquire.  An email reply told me that it was compiled, ‘by Dignity in Dying from assisted dying organisations Dignitas and Life Circle.  Not all assisted dying organisations in Switzerland publish data.  The timeframe is from 2002 – when the first person from Britain has an assisted death at Dignitas – to July 2023.’  That amounts to about 30 people per year from the UK – that is a figure I do recognise.  It is less than one per week.

The Report in question is entitled, ‘TIME FOR CHOICE The truth about the UK’s ban on assisted dying … and how things could be better’ and it was published in September 2023.

The Report is a heady, polemical mix of facts and stories.  For example, it found that more than half of Britons, or 56%, would consider an assisted death in Switzerland if terminally ill, but that less than a third could afford it.  Apparently, ‘The average cost of travelling abroad for an assisted death in Switzerland is £15,000.  This cost has increased by 50% in the past 5 years.  63% of people in England and Wales cannot afford this.’  In other words, DiD concludes that the UK ban on assisted suicide is creating a two-tier system of dying for Britons.  In addition, the Report includes several personal stories.  For instance, there is a moving account by Lisa Boeyen, whose husband Stephen, died at Dignitas.  Lisa wrote, ‘It is not easy to lose someone dear to you.  Stephen and I had been together for 35 years.  But perhaps my account of the process helps you understand that it was a very peaceful, calm, safe environment for someone to end their life.’

Moreover, palliative care has never been enough for DiD people.  The Report revealed that one in seven NHS trusts in England and Wales have had patients receiving palliative care who take their own lives or attempt suicide.  Thirteen out of 80 Trusts, or 16%, had experienced suicides or attempts by palliative care patients in the last five years.  DiD thinks these people would have benefited from assistance in their suicides.  What we need urgently is to expand the provision of proper care at the end of life, and to develop suicide prevention strategies to support people who are elderly, sick or disabled.

Furthermore, the Report complains that the so-called ‘blanket ban’ on assisted suicide is because of the 1961 Suicide Act Section 2(1) which stipulates that, ‘A person who aids, abets, counsels or procures the suicide of another, or an attempt by another to commit suicide, shall be liable on conviction on indictment to imprisonment for a term not exceeding fourteen years.’  Yet this law punishes those who assist, it protects the vulnerable and it has a deterrent effect.  That is what good laws do.

Whatever figures are presented for the numbers going to Switzerland and elsewhere, like the 632 in this Report, they are miniscule compared with the numbers dying naturally back home in England and Wales.  These amount to approximately 500,000 each year or 10,000 each week.  Compare that weekly 10,000 with the one or so going to Switzerland each week.

So, do you think that DiD’s call for a change in UK law that gives ‘… terminally-ill, mentally-competent adults, the option of controlling the manner and timing of their deaths within a robust legal framework that protects everyone in society’, will remain unchanged if enacted?  Will there not be a slippery slope that widens the criteria of eligibility, drawing in more and more vulnerable people?  Ask if that has happened, for example, in Canada, the Netherlands, Belgium and elsewhere (see below).

We need to get a well-informed understanding of assisted suicide.  Discussion of the topic too often descends into horror stories about the agonising death of ‘my aunt Mary’.  Assisted suicide has become something of a niche issue governed mainly by an elite of articulate, strong-minded, strong-willed men and women – the sort you see on programmes about going to Dignitas.  They can tug at your heartstrings.  But understanding raw data is also important.  For example, in this Report, DiD states that ‘British membership of Dignitas is at an all-time high.’  Statistically that is true, but according to the latter’s website, the latest count in 2022, put the number at a mere 1,528 paid-up Britons.

And here is something else that DiD would prefer you not to know.  In 2019, according to a DiD poll, ‘84% of the public support the choice of assisted dying for terminally ill adults.’  However, the more recent 2023 poll by DiD showed that this figure has dropped to 78%.

Laws and victims of assisted suicide and euthanasia seem to be on the increase worldwide.  Soon these issues will be coming to a place near you – are you prepared?

MAID in Canada, the bad exemplar
No commentary on the state of assisted suicide around the world can exclude the dire situation in Canada.  Indeed, more people are being euthanised in Canada than anywhere else in the world.  In the latest official report, for 2022, 10,064 people died through what Canadians call ‘medical assistance in dying’ (MAID).  In the Netherlands in the same year, there were 7,666 euthanasia deaths and in Belgium there were 2,699.

Canada passed its MAID law in 2016.  And if ever there was an example of the slippery slope, Canada is it.  In 2016, the criterion was a terminal illness.  Then in 2021, the criteria included people who were suffering from non-terminal conditions.  And as of 17 March 2024, the net will include people suffering solely from mental illness.  Come on, you doubters of the existence of expanding boundaries of eligibility across all bioethical issues, the so-called slippery slopes, are they mythological or real?

There is something seriously out of kilter here.  On the one hand, it has become de rigueur for politicians, doctors, celebrities, gurus and even royals to raise awareness of, and talk about, mental health and its debilitating effects.  While on the other hand, those suffering from such mental illness can become eligible for an assisted death penalty, sanctioned by the State.  Should not we help vulnerable people who think they want to die, not just help them to die?

So what is the inevitable terminus of this mad slipperiness?  Just like the calls for the decriminalisation of abortion in the UK, so Canada (and every other interested jurisdiction) will sanction a free for all – kill me under any, and every, and no circumstance.  Publicise it under the false guise of personal autonomy and freedom of choice.  And then, after a few years, logically all human life will have become pointless, undignified and valueless.  MAID will have become the death penalty for victims of the euthanasia juggernaut.

Do not underestimate the trajectory of the above.  Some in the UK are looking to Canada for guidance about implementing legal assisted suicide.  For instance, a group called UK Humanists have stated, ‘We can and should learn from Canada to create laws that are right for the UK.’  In March 2023, they have even approvingly published a report entitled, ‘Canada’s Assisted Dying Laws.’  This 12-page document concludes with this fundamental question, ‘Does the situation in Canada give reasons for the UK not to legalise assisted dying?  And it answers succinctly, ‘No.’  Our UK response should be, ‘Help!’

Help! indeed.  Because a recent article entitled, ‘The Realities of Medical Assistance in Dying in Canada’ by Ramona Coelho et al., and published in Palliative and Supportive Care (2023, pp. 1-8.) by three Canadian doctors and a bioethicist covers much of the same ground as the UK Humanist’s report, but it comes to very different conclusions.  It states, ‘The Canadian MAID regime is lacking the safeguards, data collection, and oversight necessary to protect Canadians against premature death.’  The article is an excellent overview of the status quo in Canada before MAID for mental illness becomes legal next March.  It identifies 9 ‘policy gaps’, such as ‘inadequate data collection’, ‘lack of oversight’ and ‘undefined terminology’.  Let these serve as warnings to other jurisdictions, including the UK.

Even that is not all.  In March 2023, the Canadian Government proposed new guidelines published as ‘Model Practice Standard for Medical Assistance in Dying (MAID).’  It is highly controversial.  For example, Section 6 declares that patients must be informed of MAiD if ‘MAID is consistent with the person’s values and goals of care.’  In other words, doctors and nurse practitioners are wellnigh required to recommend MAID to people who might qualify.  It continues, doctors ‘must not assume all persons potentially eligible for MAID are aware that MAID is legal and available in Canada.’  In other words, doctors should raise the issue of a person’s eligibility before counselling them one way or the other.  ‘Have you thought about MAID?’ is inseparable from a discussion of how to apply for it.  Surely that amounts to a slick sales pitch for selling the MAID package.

‘O Canada!  Our home and native land!’  What have you done?  Is this the denouement of progressive politics?  Is this where autonomy-based liberalism and false compassion collide?  ‘O Canda’, let none praise, or envy, or follow you.

RCS England and others go neutral
In mid-June, members and the Council of the Royal College of Surgeons (RCS) of England voted in favour of adopting a neutral position on assisted suicide.  In other words, the RCS dropped its long-held opposition to the practice.

The key figures were 72% of members voted to cut their opposition to assisted dying.  61% of members personally support a law change.  52% say the College should be supportive of a change in the law to permit assisted dying.

There is a trend here.  After surveying their members, a number of medical bodies, including the British Medical Association, the Royal College of Physicians and the Royal College of Nursing, have, over the past few years, all adopted a neutral stance on the issue.  However, neutrality is NOT the same as endorsement.

Are the British Isles on the cusp of a law change?  Evidence to supply a reliable answer to that question should come from the Commons inquiry into assisted dying/assisted suicide, which is currently underway, led by the Health and Social Care Select Committee.  The deadline for submissions was 20 January 2023.  Oral and written evidence has been taken during the summer 2023.  However, the inquiry’s website states that there are ‘no upcoming events scheduled.’  And there is no indication of when the report of the inquiry will be published.

In addition, proposals for law change are progressing in Holyrood and the parliaments of Jersey and the Isle of Man.  In the Republic of Ireland, a special Oireachtas joint committee is currently examining the topic.  And in France, President Emmanuel Macron has announced a national debate with a view to legalising assisted suicide by the end of 2023.

Again, laws and victims of assisted suicide and euthanasia seem to be on the increase worldwide.  Soon these issues will be coming to a place near you – are you prepared?

Genetic Engineering

Gene therapy for Duchenne muscular dystrophy
The US Food and Drug Administration (FDA) has recently approved the first gene therapy for Duchenne muscular dystrophy (DMD).  DMD is a rare, degenerative disease that progressively robs children of muscle function.  It is caused by a mutation in the gene that codes for the protein, dystrophin.  This protein is essential for the strengthening and connecting of muscle fibres.  DMD causes a progressive weakening of these muscles from the age of about three, eventually it adversely affects the muscles of the heart and lung.  It is an X-linked recessive condition that predominantly affects boys.

The gene therapy drug is known as Elevidys (delandistrogene moxeparvovec-rokl).  It has been approved for children between the ages of four and five who can walk and have a confirmed mutation in the dystrophin gene.  It uses an adeno-associated virus to deliver micro-dystrophin, a shortened version of the dystrophin gene, into cells, which in turn triggers production of the protein.  The large size of the original dystrophin gene prevents its full-length version from being delivered using this technique.

Currently treatments for DMD address only its symptoms.  They include anti-inflammatory corticosteroid drugs, which may improve muscle strength, and equipment, such as wheelchairs to aid mobility.  A few targeted drug therapies have already been approved, but they require repeated administration.  By contrast, Elevidys requires only a single intravenous infusion.

Elevidys is the first gene therapy to be approved through an accelerated FDA route, reserved for the most serious conditions with an unmet need.  The FDA’s decision was contentious – the panel of 14 experts approved the drug by 8 votes to 6.

Sarepta Therapeutics, a biotech company with headquarters in Cambridge, Massachusetts, describes itself as, ‘A global biotechnology company on an urgent mission: to engineer precision genetic medicine for rare diseases that devastate lives and cut futures short.’  Currently it is conducting a Phase III clinical trial of Elevidys involving 126 volunteer patients – results are expected to be published by the end of 2023.

A smaller Phase II trial was started in 2018.  However, the results have yet to be published in a peer-reviewed journal.  Each of its 41 DMD patients, aged between four and seven, received a single dose of either Elevidys or a placebo.  Dystrophin levels were measured at 12 weeks.  It may be that younger patients benefited the most – if so, then this may explain the revised age-based approval restrictions for Elevidys by the FDA.

Elevidys is not without problems.  It has shown to cause some adverse side effects, including vomiting, nausea and worsening liver function.  Another potential drawback is that it is expected to cost $3.2million per patient.  However, this may still prove to be cost effective compared to existing targeted therapies because of Elevidys’ single administration.

He and Alzheimer’s
Remember the controversial Chinese scientist, Dr He Jiankui?  In 2018, he claimed to have created the world’s first genome-edited humans in order to make the twin girls, known as Lulu and Nana, resistant to HIV.  That feat caused a serious uproar among the scientific community and the general public.  He had overstepped the bioethical red line into heritable human embryo genome editing for reproductive purposes. 
In 2019, he was fired from his university job, jailed for three years and fined three million yuan (£330,000) by a Chinese court.  The court said he had been ‘illegally carrying out human embryo gene-editing intended for reproduction.’  He was released from prison in April 2022.

And apparently, he is now back at the laboratory bench.  Most recently, in June 2023, He announced that he is hoping to pioneer a cure for Alzheimer’s disease.  He proposes to again modify human embryos, which, he claims, will help the ‘ageing population’.  He has posted on Twitter/X, ‘I am proposing a research project “Human embryo gene editing to protect against Alzheimer’s disease.”’  He continued, ‘The ageing population is of grave importance as both a socioeconomic issue and a strain on the medical system.  More than 5% of the population above 60 years old is effected [sic] by dementia; of these, two thirds are the result of Alzheimer’s disease (AD).  Currently, there is no effective drug treatment for Alzheimer’s disease.’

He then explains his proposed scientific approach.  It begins, ‘The APP gene point mutation A673T was discovered [Jonsson et al., 2012] to decrease the incidence of this disease.’  The central statement is, ‘We propose to introduce the APP(A673T) mutation into embryos, and test whether this mutation confers protection against Alzheimer’s disease.  This will be accomplished by base editing, rather than using CRISPR-Cas9 editing, first, in mouse embryos and then in human tripronuclear zygotes.’  Finally, He notes, ‘no human embryo will be implanted for pregnancy in this study.’

Scientists have variously called this proposal ‘highly questionable’ and ‘insane’.  In March 2023, more than 200 Chinese scholars issued a statement condemning He’s ‘… attitude and refusal to reflect on his criminal actions of violating ethics and regulations of gene editing.’  Furthermore, there is a puzzling practical aspect to this proposal because He is serving a lifetime ban of working in reproductive technology.

Gene therapies for rare diseases
Some gene therapies produce good results in clinical trials, but then fail to become commercial successes.  This is for two main reasons.  First, the therapies tend to be expensive and second, the diseases tend to be rare and so a biotech company is unlikely to recoup its development costs, let alone make a profit.

To illustrate this dilemma, here is the tale of Strimvelis.  It is a potent treatment for so-called ‘bubble-boy babies’ aka ADA-SCID (adenosine deaminase form of severe combined immunodeficiency), a devastating immune disorder.  It was one of the first gene therapies to be approved in Europe.  In 2018, GlaxoSmithKline (GSK) sold Strimvelis to Orchard Therapeutics.  But in 2022, Orchard dropped it – though Strimvelis was highly effective in treating the disease, it was not turning a profit.  Its potential market was minuscule – it affects only 1 in 200,000 live births in Europe.  Strimvelis was one of gene therapy’s greatest successes, but one of its greatest disappointments.

However, at least for Strimvelis, all is not lost.  The Italian charity, Telethon Foundation in Milan, has announced that it will produce Strimvelis itself.  In a statement on 12 September 2023, Francesca Pasinelli, general manager of the Telethon Foundation said, ‘We are making a paradigm shift.  We are the first non-profit organization to take on the commercialization of a gene therapy.’

Indeed, it is a paradigm shift.  The charity’s scheme offers hope to scientists who have spent decades developing gene therapies for rare disorders, only to find that the standard way of getting those treatments to people in need – licensing them with for-profit companies – is unavailable.

Other routes for funding the research, development, manufacturing and approval of gene therapies for rare diseases are needed.  But non-profit agencies do not normally have deep pockets.  How many generous billionaires are out there?

Stem-cell Technologies

Transplant without immunosuppression
An eight-year-old girl has become the first patient in the UK to receive a kidney transplant and not require lifelong immunosuppressive medication.

Researchers and doctors from Great Ormond Street Hospital for Children (GOSH) in London 'reprogrammed' Aditi Shankar's immune system before performing the kidney transplant.  This reprogramming meant that immunosuppressant drugs, to stop her body rejecting the donated kidney, were not needed.  This success story was achieved by first transplanting bone-marrow stem cells from her mother, Divya, who also later donated the kidney.  She has said, ‘I was so happy to give her blood cells and a kidney.  I just feel so proud.’

Professor Jeremy Hughes from Kidney Research UK warned that ‘Like any new treatment, it is not without risk and in this case as stem-cell transplantation means the patient must also undergo chemotherapy and radiotherapy.  However, for a patient to receive a transplant and not require a lifetime of immunosuppressant medication is a significant breakthrough.  And though the process is limited in scope, it does open the door for further future development that could have the potential to overcome one of the major challenges in transplantation care.’

Transplant surgery needs immunosuppressants.  However, anyone taking such drugs is at higher risk of an infection, among other complications.  In addition, they usually need to be taken lifelong, but in this case, as the bone marrow stem cells and kidney came from the same donor, Aditi was able to stop taking immunosuppressant drugs a month after surgery.

Prior to the transplant Aditi suffered from an extremely rare inherited condition, Schimke's immuno-osseous dysplasia (SIOD).  She was spending significant time receiving dialysis to remove waste products and excess fluid from the blood when her kidneys stopped working properly.  As the disease progressed Aditi was on dialysis for 24 hours a day.  Six months following the bone-marrow stem-cell transplant, she was well enough to receive the kidney transplant.

According to Stephen Marks, clinical lead for renal transplantation at GOSH, ‘She is the first patient in the UK who has had a kidney transplant to not require immunosuppressive medication after the surgery.  A month after the transplant, we were able to take her off all of her immunosuppression, which means she doesn't get the side-effects of the drugs.’

Now Aditi is a regular 8-year-old.  She is off immunosuppression and dialysis, but swimming, singing, dancing and playing on her trampoline.  Back at school her favourite subject is science and she has developed a keen interest in biology.

Although this is a significant breakthrough in transplantation care, the procedure is unlikely to be widely used, as the double-transplant carries increased risks to the patient.  Even so, chalk it up as another success story derived from using bioethically-acceptable adult stem cells.

Stem cells and multiple sclerosis

A new study suggests that a therapy used to treat blood cancers could slow the progression of a common type of multiple sclerosis (MS) known as relapsing-remitting multiple sclerosis (RRMS).

The work was entitled ‘Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study’ and published in the Journal of Neurology, Neurosurgery and Psychiatry
(2023, 0: 1–9) by Thomas Silfverberg, et al.

Such stem-cell transplants aim to reset the immune system and researchers hope that this therapy might become part of standard care for MS patients in the future.  The treatment is based on the use of autologous haematopoietic stem-cell transplantation (aHSCT) blood cells that are harvested from the patient’s own bone marrow or blood and then reintroduced following chemotherapy.  The current study aimed to assess the efficacy and safety when aHSCT is used in routine healthcare.

Silfverberg and his colleagues assessed 174 RRMS patients who were treated with aHSCT in Sweden between 2004 and 2020.  More than half of the participants experienced improved disability, and approximately two-thirds displayed no evidence of disease activity over a 10-year period.  It was calculated that a typical patient had 1.7 relapses in the year before aHSCT treatment but would have one relapse only every 30 years after treatment.

Moreover, because the incidence of severe adverse events was low, and there was no record of treatment-related mortality, it was concluded that aHSCT is both effective and safe to use within routine healthcare.

According to the MS Society UK, there are more than 130,000 people with the condition in the UK and nearly 7,000 have it newly diagnosed each year.  Symptoms include fatigue, muscle spasms and pain, as well as problems with vision, mobility, thinking, talking and swallowing.

Dr Sarah Rawling of the MS Society UK confirmed that, ‘[Treatment] on the NHS is subject to strict eligibility criteria and can be difficult to access.  We also know [aHSCT] doesn’t work for everyone with MS, but it has been an important development in MS treatment and some people see life-changing results.  This study provides further evidence as to how it can help slow progression of symptoms.’  There are limited data available comparing this stem-cell treatment and the most effective therapies available in the UK, such as Ocrelizumab, Alemtuzumab, Cladribine and Ofatumumab.  However, such a comparative trial, called StarMS, is currently underway at several UK sites led by the University of Sheffield.

The legacy of a stem-cell charlatan
Not all is wonderfully well in the realm of stem-cell technologies.  Quacks and scandals do exist.  One of the greatest such disasters is associated with the name of Paolo Macchiarini, the 65-year-old Italian surgeon.  His tales of lies and deceit have already been covered in several editions of these Updates on Life Issues.

Macchiarini first came to notice among the general public in 2008 when he transplanted a trachea donated from a cadaver and colonised it with adult stem cells from the recipient, Claudia Castillo.  This novel treatment opened up a new and exciting world of stem cells and tissue engineering.  Initially, all seemed hunky-dory.  However, surgical success began to evade the medical showman, Macchiarini, and he became impulsive and manipulative.  He was accused of various unethical practices as 7 of his 8 subsequent tracheal transplant patients died and as several of his research papers were retracted.

Events are now beginning to catch up with this charlatan.  For several years he worked in Sweden, principally at the Karolinska Institutet, from where he was fittingly fired.  On 21 June 2023, the Court of Appeal in Stockholm concluded that Macchiarini’s interventions on three patients, who later died, amounted to serious assault.  He was sentenced to two and a half years in prison.  He is yet to be incarcerated because he is appealing his sentence.  And so this wily, disgraced stem-cell surgeon is still escaping justice.


Ian Wilmut (7 July 1944 – 10 September 2023)

Professor Sir Ian Wilmut was the leader of the scientific team that created the world’s most famous sheep, Dolly the clone.

Ian Wilmut was born in 1944 at Hampton Lucy, a pretty little village near Stratford-upon-Avon in Warwickshire.  He was the son of Eileen and Jack Wilmut, a maths teacher.  He grew up in Coventry before the family moved to North Yorkshire, where he attended Scarborough High School for Boys – his father taught at the school.

As a teenager, Wilmut wanted to join the Royal Navy but, because of his colour blindness, he was unable to do so.  Instead, he studied agriculture at the University of Nottingham.  He graduated in 1967 and a summer internship kindled his interest in embryology.  As a post-graduate research student he moved to Darwin College, Cambridge where, in 1971, he was awarded his PhD in animal genetic engineering for his thesis entitled, Deep Freeze Preservation of Boar Semen.

For the next two years, he worked as a post-doctoral fellow at the Unit of Reproductive Physiology and Biochemistry, Cambridge.  In 1973, he became a senior scientific officer at the Animal Breeding Research Organisation (ABRO) in Roslin, near Edinburgh.  There he led the team that produced Frostie, the first calf born from a frozen embryo.

Several years later, on 5 July 1996, while still at the Roslin Institute, a Finn-Dorset sheep, code name 6LLS, better known as Dolly the clone, was born.  Her significance was as the first mammal to be cloned by a technique called adult somatic cell nuclear transfer (SCNT) that used an ordinary somatic cell derived from the mammary gland of a six-year-old ewe.  Prior to her birth cloning was regarded as possible only by the use of embryonic stem cells.

Overnight, Wilmut and Dolly became global superstars.  Though her conception and birth were exceptional, Dolly went on to breed normally with a Welsh mountain ram and to produce six healthy lambs.  After suffering from a progressive lung disease and severe arthritis, Dolly was euthanased on 14 February 2003, aged six.  She is now on display at the National Museum of Scotland in Edinburgh.  There has been continuing discussion whether she was prematurely prone to these diseases because her genetic material was already six years old when she was conceived – was she effectively 12 at her death?

Because the Roslin team used SCNT to initiate the pregnancy of Dolly, Wilmut was inevitably questioned about using it to clone a human being.  He doubted it would work and he considered it would be ‘criminally irresponsible’ to try.  However, he was troubled by several surrounding bioethical issues – for example, he recognised that every use of embryonic stem cells involved the destruction of embryos.

In 2005, after the excitement of Dolly, Wilmut turned his attention to regenerative medicine and especially the use of induced pluripotent stem cells (iPSCs) as discovered by Shinya Yamanaka in 2006.  In 2008, Wilmut announced that he was abandoning SCNT cloning and embryonic stem-cell research in favour of using iPSCs.  This was BIG news.  It was sufficiently ground-breaking for Wilmut to conclude that ‘This [the use of iPSCs] is the future of stem-cell research.  I have no doubt that in the long term, direct reprogramming will be more productive.’  He was appointed professor of reproductive science at the University of Edinburgh and a year later was made director of the Centre for Regenerative Medicine at the University.

Eventually, in 2012, Wilmut retired and just six years later he was diagnosed with Parkinson's disease.  He had known for some time before his diagnosis that he was ill but suffered a crisis when he suddenly found himself unable to move while walking his dog.  He became a patron of a research programme developing novel therapies to slow the progression of the disease.  He told The Times that he was ‘happy to act as a guinea pig and either donate tissue or try new treatments.’  Poor Ian, he admitted that he struggled to come to terms with the condition and its seemingly endless regime of drug-taking.

He experienced moments of frustration when he wanted ‘to kick the furniture’ and his diagnosis brought him a sense of his own mortality.  He explained, ‘With these serious conditions I rather get the impression that the first question people ask is, ‘How long have I got?’  ‘My doctor didn’t wait for me to ask, he said, “Ten, 15 years.  It’s not bad.  You can have a lot of fun in ten or 15 years.”  In the end he had only five.

Ian Wilmut was a modest and self-effacing man.  He declined to be present at the birth of Dolly and was instead digging in his garden.  He was appointed OBE in 1999 and elected a Fellow of the Royal Society in 2002 and knighted in 2008.  He is survived by his second wife, Sara Haddon, whom he married in 2017.  He met his first wife, Vivienne (née Craven), while at school.  She predeceased him in 2015 after a 48-year marriage.  He is also survived by their daughters, Helen and Naomi, and a son, Dean, who was adopted on the statistical calculation that he and Vivienne could not know how many more girls they might produce before they had a boy.  Slightly weird, but essentially sweet.

Sleep, balm of hurt minds

The lifestyle sections of newspapers, magazines and TV programmes are littered with items about the essentialness of sleep and how to get it.  Insomnia is like a modern-day plague but even in Shakespeare’s day the benefits of a good night’s sleep were recognised –
‘Sleep that knits up the ravell’d sleeve of care,’
The death of each day's life, sore labour's bath,
Balm of hurt minds, great nature's second course,
Chief nourisher in life's feast.’
Macbeth, Act 2, Scene 1.

Sleep has a profound impact on human health – it improves attention, memory, emotional regulation and work performance, and it reduces the risk of disease.  Are you getting enough?  Over the past few decades, the amount of sleep that people get has declined substantially.  A 2017 study of some 690,000 children from 20 countries found that nightly sleep duration fell by more than an hour from 1905 to 2008.  Nearly one-third of adults in the United States sleep for less than six hours per night.  So, is it modern-living patterns, digitalization, globalization and social media that are making people squeeze more into their day at the expense of sleep?

Nikki Forrester, a freelance science writer and editor based in West Virginia, has helpfully summarised our current understanding of sleep and our need of it in an article entitled ‘How better sleep can improve productivity’ and published in Nature (2023, 619: 659-661).

Studying sleep, its disorders and the genetic mechanisms that regulate it is a relatively new area of research.  It was inaugurated largely by the discovery of very specific brainwave patterns that occur during sleep.  This discovery was made in 1929 by the German psychiatrist Hans Berger.  He used a technique called electroencephalography (EEG), which measured electrical activity in the brain.  Eight years later, a group of scientists used the same technique to identify and classify different stages of sleep.

Today, most researchers describe sleep as occurring in two main phases – rapid-eye-movement (REM) sleep and non-REM sleep.  Non-REM sleep comprises three stages, known as N1, N2 and N3.  These are characterized by specific brainwave patterns that reflect neural activity.  These three stages of non-REM sleep plus REM sleep comprise the sleep cycle, and people who sleep well typically experience four to six cycles every night.

The average adult seems to need 7 to 8 hours of sleep per night.  However, some need only 3, while others need 12 or 14 hours.  Along with differences in sleep duration, individuals vary in when they feel sleepy and when they feel awake.  For instance, the ‘larks’ prefer to go to bed early and rise early, whereas the ‘owls’ like to stay up late and sleep late.

So what is happening when we sleep?  When someone is awake, an EEG of their brain shows lots of neurons firing, but not in a completely coordinated way.  Then, as the person starts to go into a light sleep, or the N1 stage, the neurones slow down into a pattern called theta waves.  This stage typically lasts for one to ten minutes.

During the second phase of sleep, N2, body temperature drops, heart rates and breathing slow down and muscles relax.  Brainwave frequencies now oscillate between slower waves and short bursts of neural activity.  This phase generally lasts 10 to 25 minutes during the first sleep cycle, but gets progressively longer in later cycles, ultimately comprising about half of a person’s sleep time each night.

Slow-wave sleep occurs in the N3 stage, which is characterized by slow waves called delta waves.  This 20 to 40-minute phase makes up about one-quarter of a person’s sleep time.  This is feelgood sleep.  It seems essential to restoring energy levels, repairing and growing tissues, clearing waste and boosting the immune system.  This slow-wave sleep also aids learning and memory consolidation.

Neural activity picks up when the body enters REM sleep, which is when dreaming occurs.  In this phase, which comprises one quarter of sleep time each night, the brainwaves follow a beta-wave pattern.  As the night progresses, the periods of slow-wave sleep shorten and REM sleep increases.  REM sleep is important for cognitive functions, such as emotional regulation, memory and creative problem-solving.

So, we now have a decent understanding of the various phases of sleep, but the question of what sleep does remains largely unanswered.  This is truly fascinating – we all experience it yet we are completely unaware of it.  How busy our brains can be, even when we are not.

Good night!  I hope so.

Are human clinical trials trustworthy?
When you are prescribed and take your medicine, do you expect it to work or, at least, be safe?  Of course, you do.  Why?  Because it has been ingeniously developed by skilled scientists and manufactured by a responsible pharmaceutical company.  Between these two strategic pillars of bringing a medicine to market lie human clinical trials, typically consisting of four phases – testing in vitro, in animals, in limited number of humans, and in large numbers of humans.  Strict rules and regulations govern the entire series of procedures.

But are you sure?  Really sure?  This recently-published article may rattle your confidence.  It is entitled, ‘Medicine is plagued by untrustworthy clinical trials.  How many studies are faked or flawed?’ by Richard van Noorden, a Features Editor at Nature, and it appeared in Nature (2023, 619: 454-458).

The idea of flawed studies in science is nothing new.  Human error, accidental and deliberate, is inevitable in all human activities.  However, the scale of untrustworthy science is quite unknown and has been debated for eons.  But interest in the very modern phenomenon can be dated to around 2020 when John Carlisle reported a startling estimate of its length and breadth.  His paper was entitled, ‘False individual patient data and zombie randomised controlled trials submitted to Anaesthesia’ by J B Carlise and published in Anaesthesia (2020, 76: 472-479).

Carlisle is an anaesthetist working for the NHS.  He has an uncanny knack of spotting suspicious data derived from medical trials.  In 2017, he decided to scour all the manuscripts that came across his desk as an editor of the journal Anaesthesia.  He paid particular attention to those studies that included a randomized controlled trial (RCT), the so-called gold standard of medical research.  Over three years, he scrutinized more than 500 studies.

Hold onto your hat.  For more than 150 trials, Carlisle got access to anonymized individual participant data (IPD).  By studying the IPD spreadsheets, he judged that 44% of these trials contained at least some flawed data, such as impossible statistics, incorrect calculations or duplicated numbers or figures.  And 26% of the papers he judged had problems that were so widespread that the trial was impossible to trust, either because the authors were incompetent, or because they had faked the data.

Carlisle called these ‘zombie’ trials because they had the semblance of real research, but closer scrutiny showed they were actually hollow shells, masquerading as reliable information.  Even he was surprised by their prevalence.  He stated that, ‘I anticipated maybe one in ten.’

Carlisle went further.  When he did not have access to the raw data of a trial, he studied the aggregated information in the summary tables.  He found that just 1% of these were zombies and 2% had flawed data.  Carlise was alarmed.  It seemed that without access to the IPD, which journal editors rarely request, and reviewers never see, even experienced data detectives like Carlisle cannot spot the hidden flaws.

He wrote, ‘I think journals should assume that all submitted papers are potentially flawed and editors should review individual patient data before publishing randomized controlled trials.’  Carlisle rejected every research manuscript that contained a zombie trial, but almost three years later, most of them had been published in other journals, sometimes with different data to those submitted with the manuscript he had originally seen.

Do Carlisle’s findings in the field of anesthesiology extend to other academic disciplines?  For years, a number of scientists, physicians and data detectives have argued that fake or unreliable trials are frighteningly widespread.  They have scoured RCTs in various medical fields, such as women’s health, pain research, anaesthesiology, bone health and Covid-19, and have found dozens or hundreds of trials with seemingly statistically impossible data.  Some scientists, on the basis of their personal experiences, say that 25% of trials regarded as untrustworthy might be an underestimate.  For example, Ian Roberts, an epidemiologist at the London School of Hygiene & Tropical Medicine maintains that ‘If you search for all randomized trials on a topic, about a third of the trials will be fabricated.’

Does the frequency of flawed and fake research matter?  Of course!  It can be dangerous because the results from such research trials can find their way into recommendations for drug approvals and medical interventions.  In other words, patients can be at risk of sub-standard, or even unsafe, treatments.

What can be done?  So much depends upon the system of manuscript reviewing by academics.  They are the crucial gatekeepers.  They need a large dose of scepticism and a fully attentive brain.  But they are often hard-pressed scientists, who are unpaid volunteers – reviewing manuscripts is generally not top of their agenda.  Perhaps a harsher system of reviewing is required with penalties for those caught deliberately cheating the system with shoddy work.

Meanwhile, keep taking the old, tried-and-tested pills
the overwhelming majority are safe and effective.  It is the new ones that are more likely to have slipped through the net of recent human clinical trials.

USA + Elsewhere

America post-Dobbs
What has happened since the landmark judgement in the Dobbs v. Jackson Women’s Health Organization case that uprooted Roe v. Wade on 24 June 2022?  There have been some good things and some bad things.  The abortion landscape has become extremely fragmented and increasingly polarized.  Many states have implemented abortion restrictions or bans making it difficult, if not impossible, for women to access abortion clinics.  Other states have taken steps to protect so-called abortion rights and access.  There has been a myriad of new laws, legal challenges, clinic closures, demonstrations, threats and general unease.

It would be impossible to describe the actions and emotions since Dobbs was handed down.  So the following is but a snapshot of what has occurred and what is likely to occur in the near future.  Overall, post-Dobbs has left approximately 22 million US women and girls living in states where abortion is heavily restricted or largely inaccessible.

So far, more than a dozen states have enacted extremely restrictive abortion bans, with the majority making no exceptions for rape or incest.  And many more are waiting for legal challenges to make their way through the courts.

Consider the mid-Western territory of Indiana, the so-called Hoosier state.  Previously abortion in Indiana was legal up to 20 weeks.  In 2022, its new abortion law, Senate Bill 1, was the first to be passed after the US Supreme Court overturned Roe v. Wade.  Then in 2023, a near total ban was enacted with exceptions for fatal foetal abnormalities, to preserve the life and physical health of the mother, or (before 10 weeks post-fertilisation) in cases of rape or incest.  In these cases, the abortions must be performed in a hospital.

What about Oklahoma, nicknamed the Sooner state?  In May 2022, Oklahoma’s Governor, Kevin Stitt, signed into law the most protective abortion ban in the whole USA at that time.  The measure was a Texas-style law, but instead of protecting the unborn after six weeks, when their heartbeats can be detected as the Texas law does, it starts protecting them from conception, when their lives truly begin.  The ban went into effect immediately and Oklahoma has since instituted a full abortion ban protecting all unborn children.

The Oklahoma health department has published a report showing that the May 2022 ban has been successful in helping women and in protecting the unborn.  There were 2,160 abortions reported across Oklahoma in 2022, down by 70% from the 2021 figure of 7,287.  In addition, medical abortions dropped by 75% from 5,009 in 2021 to 1,255 in 2022.  It is estimated that the abortion rate of Oklahoma has decreased by 70% to 2.7 abortions per 1,000 women aged 15 to 44 and that it is at its lowest point since the state started collecting abortion data in 2002.

All this is great news for Oklahoma, Indiana, Texas and all the other states that are striving to decrease the numbers of abortions and to increase the provision of care for their mothers and their babies.

What is an American abortion?
If ever a country was divided by the abortion issue, it must be America.  The pro-abortion-pro-choice partition is as wide and as deep as ever.  Yet some commentators are detecting a change in the old rhetoric.

One of the best illustrations of this shift in language is the rebranding of one of the leading American pro-choice organisations, NARAL.  It was launched in 1969 as the National Association for the Repeal of Abortion Laws.  Then following the 1973 Supreme Court decision in Roe v. Wade, NARAL became the National Abortion Rights Action League.  And in 2003 it was named NARAL Pro-Choice America.  Finally, in September 2023, the organisation became known as Reproductive Freedom for All.

Its website describes this 2023 ‘charting a new path forward’ as, ‘For over 50 years, Reproductive Freedom for All (formerly NARAL Pro-Choice America) has fought to protect and advance reproductive freedom at the federal and state levels – including access to abortion care, birth control, pregnancy and post-partum care, and paid family leave – for everybody.  Reproductive Freedom for All is powered by its more than 4 million members from every state and congressional district in the country, representing the 8 in 10 Americans who support legal abortion.’

That is the rhetoric, but what is really behind these changes?  Again, its website states, ‘Our research has shown that reproductive freedom is a core value for people across the country – across religion, race, and age.  With this change, our organization boldly forges ahead toward a future where reproductive freedom is a reality for everybody.'

The old NARAL’s shift from ‘choice’ to ‘freedom’ is interesting and a significant wordplay.  Moreover, according to the Guttmacher Institute, the foremost US pro-choice think tank, these changes merit further discussion.  A research paper entitled, ‘“Technically an abortion”: Understanding perceptions and definitions of abortion in the United States’ by Alicia J VandeVusse and her colleagues, mainly from the Guttmacher Institute, was published in Social Science & Medicine (2023, 335: 116216).  Reporting on people’s reactions to several abortion-related vignettes, such as miscarriage, emergency contraception or abortion pills, lead author Alicia VandeVusse concluded that, ‘Our biggest takeaway is that people do not hold a shared standard definition of what is and isn’t an abortion.’  ‘We found that there’s a lot of nuance and ambiguity in how people are thinking about these issues and understanding these issues.’

Other examples of confusion were evident.  For instance, one of the vignettes employed the phrase ‘had a surgical abortion.’  Yet 67% of respondents said, yes, that’s an abortion, 8% said maybe, but 25% said no.

Furthermore, there is no doubt that the word ‘abortion’ is stigmatising.  This may explain NARAL’s name change away from ‘abortion’ and ‘pro-choice’.  The ‘pro-life’ community has its challenges too.  Originally the phrase was a stroke of PR genius, as no politician wanted to be labelled ‘anti-life’.  However, while accurate, it, too, can be problematic in public communications, such as debates, articles and so on.  Do these two journalistic shorthand labels now communicate some form of extremism?  For instance, ‘pro-life’ can be associated with ‘no exceptions’ and ‘pro-choice’ can mean ‘pro-abortion’ with both possessing an undertone of hard-heartedness.

And we thought we understood the simple meaning of pro-choice and pro-abortion, but language and comprehension move on.  Above all, what the Guttmacher paper clearly shows is that better education and clarity of definition are required around the abortion issue.  Or will the pro-life camp get left behind in the epoch of new rhetoric?

Malta, the last European pro-life outpost
This little island nation is the only country in the EU in which abortion is still illegal under any circumstances – it provides full protection for the unborn child enshrined in law.  And the mother is protected too – the Maltese Criminal Code, Articles 241-243 state, ‘Should the mother’s life be in danger, all efforts are made to save both lives, and the double effect principle applies, such as in ectopic pregnancy.’  However, there is a good deal of misinformation about Maltese abortion law.

Of course, these pro-life laws are anathema to many and they have been subjected to constant challenges.  One such challenge has become known as the Prudente case.  In June 2022, Malta came under international pressure to review its abortion legislation after it was claimed that Andrea Prudente, a US citizen, who was 16 weeks pregnant and bleeding heavily with an incomplete miscarriage, had been denied an abortion that was needed to save her life when she was in Malta on holiday.  At the time, much misinformation was circulated online and in other media networks about abortion legislation in Malta.  Eventually, Andrea Prudente was transported to the Son Espases University Hospital in Palma de Mallorca where she apparently received appropriate treatment including the removal of foetal tissue because she was at risk of a life-threatening infection.

The circulating storyline was that Malta had such rigid laws against abortion that it was hard-hearted and medically deficient when it came to treating pregnant women and their unborn children.

To counter such pro-abortion propaganda, doctors in Malta immediately released statements to clarify how the law operates in Malta.  For example, Professor George Gregory Buttigieg, who is a professor of obstetrics based in Malta said, ‘Maltese law and medical precedent are absolutely clear: if a woman’s life is at risk from her pregnancy, then it is absolutely legal for her pregnancy to be ended by delivering the child, even if that child has a heartbeat, and even if the child will sadly pass away.  This would not be seen in Maltese law or medicine as an abortion.  As a Professor of Obstetrics, I have delivered babies prematurely in life-threatening situations and have never been worried about legal repercussions.’  Dr Calum Miller, an NHS GP and research associate at the University of Oxford, summarised the situation, ‘Maltese law and medical practice clearly allow premature delivery of the child where the woman’s life is at risk – regardless of whether the baby is alive, has a heartbeat, and regardless of whether it is viable.’

And are the Maltese people happy with their pro-life culture?  Apparently, yes.  A 2022 poll showed that 97% of the population opposed unrestricted abortion at whatever stage of pregnancy and 90% of the population opposed unrestricted abortion being available in the first three months of pregnancy.

Moreover, the two main political parties in Malta, the Labour Party and the Nationalist Party, both publicly support the current abortion legislation in Malta.  Ahead of the 2022 Maltese general election, following a nationwide campaign run by pro-life campaigners, both parties made public commitments to ensure the continued legal protection of unborn children.

Between June and November 2022, the Maltese government was under increasing pressure locally and internationally from pro-abortion campaigners to change its abortion law.  And so the Maltese government, led by Prime Minister Robert Abela, brought forward an abortion Bill in the Maltese Parliament.

However, at its First Reading on 21 November 2022, it became clear that the Bill went much further than simply codifying the current practice into law.  Instead, the amendment that was proposed included legalising abortion to protect the health of a pregnant woman who has medical complications that ‘may’ put her ‘health in grave jeopardy’.

On 4 December 2022, Malta experienced one of the largest demonstrations ever as thousands of Maltese people took to the streets to protest the Bill and to keep abortion out of Malta.  The Bill’s progress ground to a halt.

Then in early June 2023, Malta’s President, George Vella, made it clear that he would resign if the Government passed this Bill as it stood and therefore introduce abortion in Malta.  This was a key political juncture.  Following the mass protests, the Labour Government backed down and made the necessary U-turn.  Pro-lifers confirmed that the new wording in the Bill ‘does not introduce abortion to Malta but would codify the existing life-saving practices currently being applied in Malta, and provide further safeguards for mothers, unborn babies, and doctors.’

After months of silence, on 23 June 2023, six months after it had initially proposed the abortion Bill, the Maltese Government made an announcement that it would be making major changes to the wording of the Bill.  Once the wording had been amended, the Nationalist Party and the President were happy to give their support to the Bill for the first time.

Thus Malta retained its pro-life status.  Life Network Malta issued a statement, ‘The voice of the people of Malta has been very clear: we are a pro-life nation, valuing every life, the mother that deserves our utmost protection especially when in difficulty, the unborn child that today we have saved, thanks to this new version of the legislation, we will continue to do this.’

Top  ▲▲                           Home ►►