nov21

Update on Life Issues - November 2021

Abortion

Texas Heartbeat Act
Currently, there is only one big bioethical story – the new Texas abortion law. It has provoked newspaper articles and letters, TV programmes, court hearings, debates, website hacking, marches, fights and much more.

It is the culmination of 48 years of campaigning. In 1973, the US Supreme Court ruled, in the case of Roe v. Wade, that a woman had the constitutional right to an abortion before viability of her unborn, namely at about 24 weeks. To call it a contentious ruling would be a gross underestimate.

So, for almost five decades, the US pro-life constituency has been pressing for repeal, or at least some limitation, of this abortion legislation. For instance, in July 2013, the first Texas foetal heartbeat bill (HB 1500) was introduce by Phil King, a member of the Texas House of Representatives. However, the bill was never passed. Now, in 2021, a more serious challenge has finally emerged.

On 11 March 2021, the Texas Heartbeat Act (Senate Bill 8, SB8) was introduced into the Lone Star State legislature by Senator Bryan Hughes. After debates and votes in both the Texas Senate and House, it was signed into law by the Texas Governor, Greg Abbott, on 19 May. And it came into effect on 1 September.

This highly-restrictive Act has banned abortion throughout Texas after six weeks of a pregnancy, that is, after the detection of a foetal heartbeat. It makes an exception for a medical emergency, but not for cases of rape or incest.

Pro-abortion healthcare workers and women’s groups have criticised it because of its earliness of 6 weeks, problems associated with cardiac activity detection, its intrusion into women’s rights, its disproportionate effect on black and low-income women and those who live far from abortion facilities, and so on. Yet the Act was democratically passed by members of both the Texas Senate and House, for instance, in the latter by 81 to 63.

Enraged, abortion providers, such as Planned Parenthood, and rights groups, such as the American Civil Liberties Union (ACLU), asked the Supreme Court on 30 August to intervene and issue an emergency block on the legislation. The Supreme Court, with its 6-3 conservative majority, cited procedural issues and turned down the request, acknowledging that aspects of the Heartbeat Act would continue to be challenged in the lower courts. So on 1 September, the Act came into effect. And because an estimated 85% of Texan abortions are performed after six weeks, access to almost all abortions in Texas has since been denied.

President Joe Biden has criticised the Act, calling it ‘extreme’ and saying it ‘blatantly violates the constitutional right established under Roe v. Wade.’ The Biden administration announced it plans to sue Texas on the basis that the Act ‘illegally interferes with federal interests’.

Accordingly on 9 September, the US Justice Department went to court arguing that the Act was unconstitutional. On 6 October, Judge Robert L Pitman issued an order blocking the Act. He called it ‘flagrantly unconstitutional’ and a violation of Roe v. Wade. The Judge said he would ‘not sanction one more day of this offensive deprivation of such an important right.’ However, on 8 October, the US Fifth Circuit Court of Appeals put an administrative stay on Pitman’s order. As a consequence, most abortions in Texas remain illegal.

Meanwhile, the US Supreme Court declined to intervene and hence the Texas law remained temporarily in effect, but the Court unusually heard legal arguments on 1 November. In a three-hour meeting, the Justices were asked to decide whether Texas abortion providers and the Department of Justice – in effect the Biden administration – are allowed to contest the state's new Act. One of their arguments is that the law was drafted in such a way as to evade legal review in federal courts. It is thought that a decision from the Supreme Court may come before the end of November and that it will allow the lawsuit of the abortion providers, but not that the Department of Justice, to proceed. That would be before the Mississippi court arguments begin on 1 December (see below). In the meantime, abortions in Texas have fallen by 50% since the law went into effect on 1 September.

A novel feature of the Act is that it allows ‘a private right of civil action’ so any private citizen can sue anyone who ‘aids and abets’ an illegal abortion. Thus, an ordinary American, from Texas or elsewhere, can seek a minimum of $10,000 (£7,200) in damages in a civil lawsuit against abortion providers and doctors and anyone else, maybe clinic staff, family members or clergy, who support the abortion. Opponents have called this ‘a bounty-hunting scheme’.

On 20 July, with the prospect that the Supreme Court’s consideration of Dobbs v. Jackson Women’s Health Organization could overturn the colossus of Roe v. Wade, Governor Abbott signed the so-called Abortion Trigger Bill. This proactive ‘trigger’ law would take effect after 30 days if Roe v. Wade were overturned, or if a court ruling or amendment allowed states individually to prohibit abortions. The Bill would prospectively ban all abortions in Texas, without exemption, beginning from fertilisation. Texas has therefore joined at least 10 other US states which have already passed similar measures. These would allow each state to devise its own abortion laws and would in effect protect all unborn children from abortion.

And what does the great American public make of all this? Is Texas different from the other 49 states? When a Pew Research Center poll asked about abortion, the overall US figure was that 59% agreed it should be legal in all/most cases. On the other hand, the equivalent figure from Texas folk was only 45%. Moreover, another poll conducted in April found that nearly half of the state’s voters supported a six-week ban on abortions. In other words, Texas is fundamentally a pro-life state.

Dobbs v. Jackson Women’s Health Organization
In the shadow of the novel and contentious Texas Heartbeat Act and its six-week ban of abortion sits Dobbs v. Jackson Women’s Health Organization. The Supreme Court will hear this challenge to Mississippi’s law that bans almost all abortions after the 15th week of pregnancy. The hearing is due to start on Wednesday 1 December. Judgement is expected in the Summer 2022.

Lynn Fitch, the Mississippi Attorney General, has said that she is looking forward to the opportunity to convince the Court that there is no constitutional right to abortion and that Roe v. Wade should be overturned. This is a big and bold case. Abortion in America is in flux.

IVF and ARTs

Fertility rate plummets
Data recently published by the Office for National Statistics (ONS) show the total fertility rate in England and Wales fell to 1.58 children per woman during 2020. This is the lowest figure since records began in 1938.

This has been an unmistakeable trend. This current rate is 4.2% lower than in 2019 and 3.1% lower than the previous record low in 2001. Why so? Among the reasons are, easier access to improved contraception, delays in starting a family because of career pressures and unstable relationships, the trend towards fewer offspring, financial uncertainty and the formidable cost of raising children. And the Covid-19 pandemic will have created its own negative physical and emotional impacts and accelerated this trend.

According to the ONS there were 613,936 live births in England and Wales during 2020. Almost a third (29.3%) of these were among women who were born outside the UK. The total fertility rate among these foreign-born mothers bucked the trend and increased slightly to 1.98.

The demographics and its warnings are simple. The necessary replacement rate for any country to maintain a steady population – that is, neither growing nor declining – is reckoned to be 2.1 children per woman. In 1960, the world fertility rate was 4.9 children per woman aged between 15 and 44, assumed to be her child-bearing years. At the turn of this century, it was down to 2.6, and by 2040, it is predicted to be something like 1.8. The UK’s latest rate of 1.58 is part of a trend particularly obvious among Western and rich countries in the developed world. It is a combination of low fertility and high abortion rates – currently in the UK almost a quarter of pregnancies end in abortion.

Does it matter? Yes, it does. The negative consequences of such plummeting fertility rates and the consequent numerical reductions in children will impact the health and welfare of future ageing populations, including economic growth, affordable pensions, adoptions, medical resources and so on. The effects will be profound. Some call it the ‘demographic cliff’.

New plans for IVF storage
In early September, the UK government announced its intention to extend the IVF maximum storage limit for frozen ova, sperm and embryos to 55 years. The Health Secretary, Sajid Javid, said the current limit of 10 years was ‘severely restrictive’.

The current law allows ova, sperm or embryos belonging to patients who are judged to be 'prematurely infertile', or likely to become so, such as individuals and couples freezing ova or sperm prior to chemotherapy for cancer treatment, to be kept for up to 55 years. The proposed legislation would revoke the distinction between those who are, and those who are not, 'prematurely infertile'. All patients would therefore be treated equally.

Besides this equality aspect, the proposed changes have been driven by the trend towards later parenthood as well as advances in the cryopreservation of gametes. Sperm has long been successfully frozen. Now, modern freezing techniques, known as vitrification, mean that ova can be stored seemingly indefinitely and without deterioration.

These proposals highlight yet other bioethical problems with IVF. The procedure, with the use of anonymous sperm donation, favours single motherhood and regards it as just another lifestyle choice rather than depriving the child of a biological father. Moreover, permitting the use of gametes of up to 55 years old will burden a child with an unnaturally elderly mother. Such IVF management has the propensity to put adults at its centre rather than the prospective children.

There will also need to be extra considerations of, for example, the treatment of third party sperm, ova and embryo donors in addition to the issue of posthumous donations. The proposed changes will require new legislation. This will be dependent on the Parliamentary schedule and, as yet, no date has been announced.

Surrogacy in the UK is rising
Surrogacy – one of the seemingly least objectionable and destructive of the assisted reproductive techniques (ARTs), but one that is overloaded with bioethical problems.

The number of men and women using it to raise and nurture children is rising in England and Wales. Recent research, co-led by Kirsty Horsey of the University of Kent, has found that nearly four times as many parents are using surrogacy compared with ten years ago.

The research obtained data from two sources, namely the Ministry of Justice and Cafcass (Children and Family Court Advisory and Support Service), a non-departmental body that represents children's best interests in family court cases in England. The primary statistics were derived from parental orders (POs). POs are court orders which transfer legal parenthood to the intended parents (IPs) who have commissioned a surrogate to carry a child. This legal transfer is necessary because under UK law the person who gives birth, the surrogate, is deemed to be the legal mother of the child.

Figures from the Ministry of Justice showed that 117 POs were granted in 2011. In 2019, this peaked at 444 with 413 awarded during 2020. Data obtained from Cafcass focused on the number of same-sex couples applying for POs. In 2014-15, there were 69 such applications, rising to 139 in 2019-20 and 115 in 2020-21. In other words, same-sex applicants now make up about a third of all PO applications.

Laws governing surrogacy in the UK have remained in place for almost four decades. Many consider they are no longer fit for purpose. The UK’s Law Commission is currently reviewing them and is expected to publish its recommendations in late 2022.

No baby, no fee
With one cycle of basic IVF costing around £5,000, everyone knows that a course of IVF can be expensive, crippling so in many cases. Moreover, infertility is common, affecting 1 in 7 couples, and IVF availability on the NHS is limited in extent and patchy in terms of location – 80% of NHS groups fail to deliver the NICE recommendation of three IVF cycles for women under 40. Hence, many couples go for private treatment. Yet despite spending thousands of pounds, racking up huge debts and even selling their homes, many still have no baby. After all, the overall success rate of IVF is a measly 24% or so.

Enter Care Fertility, one of the UK’s leading private IVF providers, and their new arrangement announced as a ‘no baby, no fee’ deal. It means that certain women, who do not become pregnant after three cycles of IVF, provided at a discounted rate, would get a full refund on their costs.

Care Fertility claims the package promises ‘peace of mind’. Some fertility doctors, finance brokers and former patients are concerned that the funding is being brought in-house rather than by traditional third-party financiers. They maintain that, ‘We must keep financial and clinical decisions separate.’ Otherwise they fear that such agreements might lead to overly-aggressive treatments. For example, the excessive use of ovarian stimulation hormone, a component of all IVF treatment cycles to superovulate women, can cause dangerous complications, such as ovarian hyperstimulation syndrome (OHSS).

No doubt the battle among IVF clinics for innovation, publicity and clients will continue. The poor (emotionally and financially) couples will remain as both patients and customers. And somewhere there may even be a child.

Euthanasia and Assisted Suicide

Assisted Dying Bill [HL]
Friday 22 October was another dreary, even dreadful, day for the ‘morally sensitive’. It was the day that Baroness (Molly) Meacher’s Assisted Dying Bill received its Second Reading in the House of Lords. The Bill would allow for someone, who is terminally ill and expected to die within six months, to request and be provided with a lethal prescription of assisted suicide drugs, following assessment by two doctors and approval from the High Court. It read like a draft from the Dignity in Dying organisation, formerly the Voluntary Euthanasia Society – after all, the Baroness is its current chairwoman.

The event started at 10.09 am and the House adjourned at 5.56 pm, so it lasted almost 8 hours. It was not really a debate since no-one was questioned. Instead it consisted of roughly 3-minute speeches for and against the Bill’s proposals. Listening was hard work – some speeches were good, some bad, many repetitious. On balance, they seemed to be about 50 – 50 pro and con. Probably none of them changed anyone’s mind.

There was far too much anecdotal stuff. Peer after peer was eager to recount the frightful death of a relative or constituent in pain and misery. Where was the ethical approach to such a great subject? Are we now to be governed by feelings rather than principles? The one welcome theme was praise for the wonders of palliative care and the common call for its improved funding, though this is often a ploy used by pro-euthanasiasts to demonstrate their broadmindedness and integrity.

There were two personal highlights. One came from the astute Lord Carlile of Berriew. He questioned why, on their fourth attempt, had the Bill’s supporters not yet dealt with previous holes in the safeguards. Furthermore, he pointed out that ‘Clause 1 requires the consent of the Family Division of the High Court before suicide can be assisted.’ And, ‘Have the judges been asked? There are but 20 Family Division judges.’ He proposed a calculation. ‘Let us suppose that 25% of those judges objected to the jurisdiction on grounds of conscience … and that there were 1,000 cases a year.’ And ’Each case would be bound to take two or three days before the court. In a sentence, the Family Division would be swamped by those cases.’ ‘In my view, parliamentary Bills founded on such fragile safeguarding and analysis, especially after years of trying to produce acceptable safeguards, should really not be troubling your Lordships’ House.’ True, Baroness Meacher later replied that, ‘The High Court has been consulted.’ However, Lord Carlile’s overload problem remains.

The second highlight came from the amiable Lord Winston. Concerning misunderstandings about the Bill, he said, ‘It raises the most important moral question and needs clarity without euphemism. “Assisted dying” could equally be applied to palliative care, so the Bill’s title does not represent what is really intended. The word “euthanasia” – from the Greek “eu”, meaning well or good, and “thanatos”, meaning death – is what we are actually talking about.’ He wished to amend the motion by adding, ‘but that this House considers that the bill should refer to euthanasia rather than assisted dying.’ He later withdrew this on ‘the convention of the House … that we do not move amendments at the end of a Second Reading.’ Yet Lord Winston had made a serious point. Many think that ‘assisted suicide’ would be a more precise title for the Bill rather than ‘assisted dying’, which is a good description of the work of palliative care.

In the end, there was no vote. This does not indicate a victory for the Bill’s supporters, rather it is a Second Reading procedural convention. During the debate 66 peers spoke in favour of the Bill, 62 in opposition and six, who could not attend, were against the measure. Hansard simply recorded, ‘Bill read a second time and committed to a Committee of the Whole House.’ There it will be scrutinised line by line, with amendments discussed and voted upon. When that will occur is currently unknown. Because it is a Private Member’s Bill, it would need government time to pass to the House of Commons and through its various Stages there. This currently seems unlikely. It is understood that the Prime Minister, Boris Johnson, would oppose any assisted suicide legislation. Similarly, the Health Secretary, Sajid Javid, is ‘understood to have made clear to friends that he does not intend to vote to relax the law.’

The history of assisted suicide legislation in the UK has been one of chipping away. The 1961 Suicide Act stands as the robust statute, decriminalising suicide and so protecting the vulnerable, but punishing anyone who assists. Since 2003, several attempts have been made with increasingly revised bills to amend the Act – all have failed. The last attempt in the House of Commons was in 2015 by Rob Marris MP – it too failed by 330 votes to 118.

This issue will not go away. We will again have to rehearse that assisted suicide legislation is unnecessary and dangerous. And again, we will have to prepare those slippery slope arguments. For instance, on the basis of the outcomes in jurisdictions where it is lawful, the stipulation of six months will soon be increased, other safeguards will be breached, eligibility criteria will be widened, patients with non-terminal illnesses will qualify, the vulnerable will be pursued, healthcare professions will be divided, doctor-patient relationships will be riven, substandard end-of-life care will be normalised, and the entire medico-legal framework of UK society will be changed for ever, for the worse.

The UK needs to legalise assisted suicide like the proverbial hole in the head.

Assisted Dying for Terminally Ill Adults (Scotland) Bill
Yet another Scottish assisted suicide proposal has been lodged at the Scottish Parliament. The proposer is Liam McArthur, MSP for the Orkney Islands, and a member of the Scottish Liberal Democrats.

The Bill, technically only a draft proposal, would enable competent Scottish adults, who are terminally ill, to be provided at their request with assistance to end their life. Currently, a consultation period is underway. This is due to end on 22 December 2021, then the responses will be analysed and a final proposal presented to the Scottish Parliament as a Member’s Bill. This may take months, perhaps even two years.

All the usual failings of such legislation are present in this proposal – patient vulnerability, slippery slopes, lack of safeguards, and so on. And there is a novel feature. It suggests that patients who are unable to travel due to terminal illness, or people living in small and remote communities, might be excused personal attendance with the required two independent doctors and instead be assessed by remote consultations, such as telemedicine, before being granted help to commit suicide by lethal drugs sent in the mail. It will be a sort of death via Zoom and post.

Scotland’s First Minister, Nicola Sturgeon, has spoken out against proposals to legalise assisted suicide citing fears about safeguards. Speaking before the previous Scottish debate on the issue in 2015, she said, ‘I voted against it last time and I haven't been convinced of assisted suicide this time either. A major stumbling block is the issue of sufficient safeguards. I believe we should support people to live and I am therefore in favour of good quality palliative care.’

Since Scottish devolution in 1999, there have been several failed attempts to bring the issue onto the statute book. The most recent, in 2015, was proposed Patrick Harvie, the Green MSP for Glasgow. It fell by 82 votes to 36.

Euthanasia in the Netherlands
An edition of Update on Life Issues without another ghastly euthanasia development from the Netherlands would be like a year without Christmas. Once more, another significant Dutch claim has been advanced.

First, a reminder from Germany. In February 2020, the Federal Constitutional Court declared that suicide was a constitutional right. The Court shockingly stated that, ‘The right to a self-determined death is not limited to situations defined by external causes like serious or incurable illnesses, nor does it only apply in certain stages of life or illness. Rather, this right is guaranteed in all stages of a person’s existence. It is thus not incumbent upon the individual to further explain or justify their decision; rather their decision must, in principle, be respected by state and society as an act of self-determination.’ This was, and still is, bioethical dynamite. It rips up any inherent value of human life. It dismantles all safeguarding boundaries of a society. It is human autonomy unfettered. It is death on demand.

Now, this stance has apparently been picked up in the Netherlands. It is spelled out in an article entitled, ‘Intentionally ending one's own life in the presence or absence of a medical condition: A nationwide mortality follow-back study’, by Martijn Hagens et al., and published in SSM – Population Health (September 2021).

The Dutch authors point out that, ‘Having a classifiable medical condition is a prerequisite to receive PAD (physician-assisted dying).’ They explain, ‘This study estimates the frequency of people who intentionally ended their own life’ that is, without assistance from a physician. They report that, ‘In 1.85% of all [Dutch] deaths in 2015, people intentionally ended their own life; of which 0.50% by voluntarily stopping eating and drinking, 0.20% by self-ingesting self-collected medication, and 1.15% using other methods.’

Hagens and colleagues concluded that, ‘This raises the question how to address the desire to die from people whose wish to intentionally end their own life is not rooted in a medical condition and therefore fall outside this medical framework of assistance in dying.’

In other words, how can the Dutch move way beyond, indeed outside, the boundaries of their already liberal euthanasia laws? This is a dangerous attempt to remove the medical requirement for PAD in the Netherlands. It is dangerous because it potentially includes everyone. It is also dangerous because it will prompt medical, legal and political authorities to ponder it.

BMA goes neutral
The British Medical Association (BMA) is the trade union and professional body for doctors and medical students in the UK. For many years it has maintained a policy of opposition to euthanasia and assisted suicide, or, what it prefers to call PAD (physician-assisted dying).

However, at its annual meeting on 14 September 2021, its policy-making body (known as the representative body) voted in favour of changing this official stance of opposition to one of neutrality. The vote was close, with 149 for, 145 against, and 8 abstentions. Put another way, it was 49% in favour and 48% in opposition, with 3% abstaining.

This decision was informed by the results of a survey of its members in February 2020. Of the almost 30,000 doctors (19% of those invited) who responded, 40% supported a change in the current law, 33% favoured opposition, and 21% backed neutrality. It is a confusing state of affairs.

The BMA website explains, ‘This means we will neither support nor oppose attempts to change the law. We will not be silent on this issue, however. We have a responsibility to represent our members’ interests and concerns in any future legislative proposals and will continue to engage with our members to determine their views.’

A position of neutrality signals that British doctors, as represented by the BMA, will not oppose legislation, such as, for example, Baroness Meacher’s Assisted Dying Bill. However, as one doctor, Gillian Wright, said in the BMA debate, ’Neutrality means tacit approval and has enormous political significance.’ Others say that neutrality is the best policy for reflecting the diverse views held by the BMA membership. Others say neutrality can mask strong objections.

Whichever way the BMA’s change of policy is viewed, neutrality is a middle of the road, a sitting on the fence sort of stance. It is a standpoint with no real conviction. If assisted suicide were to be legalised, what would such doctors do? Go with the flow?

Genetic Technologies

CRISPR and sickle-cell and β-thalassemia
Sickle-cell disease (SCD) and transfusion-dependent β-thalassemia (TDT) are the most common single-gene diseases in the world. Approximately 300,000 new cases of SCD and 60,000 of TDT are diagnosed each year. They are particularly widespread among people with an African or Caribbean family background. Both diseases affect red blood cells and are caused by mutations in the haemoglobin β subunit gene (HBB).

SCD patients can suffer from vaso-occlusive crises, or VOCs, which are responsible for blocking the circulation system with sickled cells, and other life-threatening events, such as stokes. Patients with TDT invariably succumb to chronic complications of iron overload, such as heart and liver failure. Both diseases significantly shorten long-term survival.

Although treatments are available, cures are what are really needed. Currently, cures involve rarely-matched donors and risky stem-cell or bone marrow transplants.

Unveiled in 2012, CRISPR-Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats) is a powerful technology that can be used to edit genes allowing researchers to alter DNA sequences and modify gene function. So, what can CRISPR do for SCD and TDT? An insight is provided in a paper by Haydar Frangoul et al., entitled ‘A CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β-Thalassemia’ that recently appeared in the New England Journal of Medicine (2021; 384: 252-260).

Two biotech companies, Vertex Pharmaceuticals and CRISPR Therapeutics, have developed CTX001, a proposed CRISPR-Cas9 gene-edited therapy for SCD and TDT. It is known that patients with SCD or TDT who co-inherit hereditary persistence of foetal haemoglobin, in which foetal expression continues into adulthood, exhibit little or no evidence of either disease.

Two patients were enrolled in this preliminary trial, one with SCD, the other with TDT. Both were infused with CTX001 to reactivate the production of foetal haemoglobin. BCL11A is a transcription factor that represses foetal haemoglobin synthesis. The research team used CTX001 to reduce BCL11A expression and revive production of foetal haemoglobin. Approximately 80% of the targeted alleles were modified, with no evidence of off-target editing. So far, so good.

More than a year later, both female patients (19 and 33 years old) had continuing high levels of allelic editing in bone marrow and blood, increases in foetal haemoglobin that were distributed throughout all cells, no need for blood transfusions, and (in the patient with SCD) no vaso-occlusive episodes. There were downsides – adverse events included pneumonia, sepsis and abdominal pain.

This was a ‘proof of principle’ trial. Initial results were positive and the protocol warrants further experimental testing of CRISPR-Cas9 gene-editing approaches to treat SCD, TDT and other genetic diseases.

Brain organoids with eyes
Here comes another clash between scientific progress and conservative, orthodox bioethics. The culprit is a paper by Elke Gabriel et al., entitled, ‘Human brain organoids assemble functionally integrated bilateral optic vesicles’ published in Cell Stem Cell (2021, 28: 1740-1757).

This controversial work used 16 batches taken from four donors of human induced pluripotent stem cells (iPSCs) to create 314 brain organoids, 72% of which formed a primitive eye structure called an optic cup. The method is therefore considered to be reproducible. These structures contained lens and corneal tissue and they responded to light and exhibited connections between the retina and regions of the brain. It was around day 30 that these brain organoids attempted to assemble optic vesicles, which developed progressively as visible structures within 60 days, similar to the rates recorded in normal human embryo development.

According to the team leader, Jay Gopalakrishnan of University Hospital Düsseldorf, ‘Our work highlights the remarkable ability of brain organoids to generate primitive sensory structures that are light sensitive and harbour cell types similar to those found in the body.’ And ‘These organoids can help to study brain-eye interactions during embryo development, model congenital retinal disorders, and generate patient-specific retinal cell types for personalized drug testing and transplantation therapies.’ That is a concise, Teutonic-like description of the work.

Many critics are less prosaic. They ask, whether there should be limits on growing human embryo-like structures which are becoming increasingly complex. For example, Paul Knoepfler of the University of California Davis School of Medicine is mildly concerned. He has written, ‘As to the human embryo models that are starting to be so similar to actual human embryos, I think limits make sense. For human brain organoids not so much. These structures are fairly far removed from actual human brains and reports of neural activity in them don’t show anything like coherent function on a consistent basis.’

Here is a more bioethically-conservative perspective. Of course, developments like these can assist in the study of inherited eye disorders, drug testing, transplant therapies, and so on. But here is human brain tissue, albeit primitive. Yet this is exactly how human embryos develop, from undifferentiated stem cells to differentiated tissues and organs. What next? The Düsseldorf team already wants to extend the viability of these organoids to allow the development of more mature eye structures.

This and other examples of controversial human research, such as three-parent embryos, human-animal hybrids and embryonic stem-cell technologies, test bioethical boundaries. The problem is that such restrictions have a habit of being legally extended or criminally breached. Consider the current pressure to lengthen the 14-day rule for human embryo experimentation, or the global prohibition on human germline gene editing until the 2018 scandal of He Jiankui.

Experiments on non-embryos, such as brain organoids, throw a spanner in the bioethical works. Of course, such structures cannot become human beings, yet they look like the products of human development. At the least there is the yuck factor. And again, how closely must such embryo-like structures resemble natural embryos before they too are considered human?

Be warned, slippery slopes exist. This year’s brain organoid may become a little more brain-like next year, and ad infinitum. There are some areas of research that should be halted and remain closed for ever. Is this one? Perhaps not yet, but in the future, probably yes.

The WHO and gene editing
It was back in 2018 that He Jiankui announced to the world that he had used CRISPR-Cas9 to create the first gene-edited humans, the twins, Lulu and Nana. The incident erupted into a vast volcano of opposition – the aftershocks are still being sharply felt. He got three years in prison, we got an unprecedented bioethical controversy for ever.

In 2019, the World Health Organization (WHO) convened an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing to investigate and report on the affair. On 12 July 2021, the WHO actually published not one, but three linked reports – a position paper, a set of recommendations and a framework for governance.

In essence, the Committee said it is too soon to allow heritable germline gene-editing in humans. Moreover, it recommended that the WHO, and especially its Director General, take on the role of global regulator in all things genomic editing. To achieve this the Committee proposed a threefold approach – the fostering of international collaboration, the encouragement of ethical reviews of human genome clinical trials, and the promotion of equitable access to genomic medicines resulting from this technology.

Although these recommendation have no legal power, they will likely influence governmental deliberations and funding authorities and so exert an indirect worldwide impact. Already several countries have gone beyond the WHO’s proposals. Some have imposed moratoriums on this sort of experimentation, and many have signed up to a registry of relevant germline clinical studies.

The WHO is not alone. In September 2020, another committee consisting of members from the US National Academy of Sciences and the UK Royal Society, with representatives from ten countries, came to a similar conclusion. That is, the technology is not yet ready to use in human embryos destined for reproductive procedures.

Not all is forbidden. Human non-reproductive, somatic genome-editing trials are approved by the WHO’s Committee. Indeed, such work is already bearing fruit. For example, clinical trials have shown promise in treating blood disorders including sickle cell disease, some cancers and the deadly, late-onset, genetic disease, transthyretin amyloidosis.

At times, this subject seems like a counsel of despair. We live in a mixed world with diverse bioethical standards, how can anything significant be proposed let alone agreed by all? Talk of transparency, inclusiveness, social justice, non-discrimination and respect for people sounds so weedy. And how can wordy reports influence the thinking and practices of governments and scientists? And what about those rogue states and anarchic scientific charlatans? But something must be done, boundaries must be constructed, laws must be enacted. To say and do nothing is not only defeatist, it will encourage the building of a dystopian world. Is that what we want?

Stem-cell Technologies

Ageing, bones and stem cells
Your body is full of biological surprises. For example, it started with just one cell, a zygote. And as you age it still fascinates. For example, think bones. As you get older your bone mass becomes less and your skeleton becomes more fragile. Such changes are hugely complex and involve a myriad of molecular and cellular processes. Besides ageing, post-menopausal women experience an additional route of bone loss associated with their declining levels of oestrogen.

Bones, like all other body parts, are constantly turning over. That is, their cells are simultaneously dying and renewing so that new material is replacing the old. In bones, this dual process of accretion and resorption is driven primarily by skeletal stem cells (SSCs) affecting the opposing actions of osteoblasts (accretion) and osteoclasts (resorption). Ageing brings about changes in the function of SSCs, which alters the balance of turnover of bone and hence its mass.

Recent experiments with mice have clarified the role of SSCs in the dynamics of this bone turnover. Thomas Ambrosi and colleagues at Stanford University School of Medicine, examined the effects of intrinsic ageing-driven changes in these SSCs as opposed to environmentally-driven changes. They removed SSCs from the bones of young (2-month-old) and aged (24-month-old) mice. These SSCs were transplanted into young recipient mice, in which the transplants formed small masses of bone tissue.

Two key differences between young and aged SSCs were reported. First, the bone mass produced by aged SSCs was much smaller than that produced by young SSCs. Second, aged SSCs exhibited an increased ability to promote the formation of osteoclasts, the blood-derived cell type responsible for bone resorption. Ageing therefore limits the ability of SSCs to maintain a healthy flux between bone accretion and bone resorption – so bone mass declines. Such insights into the complexities of bone ageing may suggest treatments for problems, such as loss of skeletal integrity, fracture healing and osteoporosis.

This work was reported as, ‘Aged skeletal stem cells generate an inflammatory degenerative niche’ by Thomas Ambrosi et al., in Nature (2021, 597: 256-262).

Stem cells and baldness
A deficiency of stem cells in hair follicles contributes to hair whitening and hair loss. Understanding the mechanism may lead to treatments to prevent baldness in humans.

Rui Yi and his colleagues at Northwestern University, Illinois, found that in the hair of ageing mice, stem cells change shape and escape the structures they are housed in, subsequently migrating away from the hair follicles. Professor Li, the leader of the research, commented, 'If I did not see it for myself I would not have believed it.’ In addition, two genes, Foxc1 and Nfatc1, were identified as responsible for trapping the stem cells in the hair follicle structure. These genes are less active in older cells, allowing the stem cells to escape. When mice lacking these genes were bred, they showed accelerated ageing, losing hair at four to five months old, with only sparse, grey fur remaining at 16 months. In other words, deletion of Foxc1 and Nfatc1 causes hair loss.

Hair whitening and hair loss were previously thought to be caused by stem cell death, a function of ageing, but this work suggests a different mechanism, known as stem cell exhaustion. The discovery of the role of Foxc1 and Nfatc1 in hair ageing could lead to potential hair loss treatments in human patients, by preventing stem cell escape from hair follicles.

This paper entitled, ‘Escape of hair follicle stem cells causes stem cell exhaustion during aging’ by Chi Zhang et al., was published in Nature Ageing (2021, 1: 889-903).

The gift of stem cells
Beth Hill is a nurse from Sedgley in the West Midlands. During the summer she entered a competition and won two tickets for the UEFA Euro 2020 semi-final football match between England and Denmark at Wembley on 7 July 2021.

Naturally she wanted to share the tickets with her boyfriend, Sam Astley. Except that Sam had to miss the match and watch it on TV from his hospital bed because he had a prior appointment to donate stem cells. He was about to undergo the removal of bone marrow from his hip bones. The prospect of watching England play in a semi-final was exciting, but he quickly realised that donating stem cells was ‘more important than any football game’. He never considered delaying the procedure.

Sam had made the appointment to donate bone marrow after he had signed the Anthony Nolan Trust's register at a football tournament organised by Beth’s friend Simon Wilkes, who suffers from a form of blood cancer himself.

In the event, Beth could not attend the match either as a close colleague had tested positive for Covid-19 at work and she had been required to isolate. She said the anaesthetist had told Sam that he had woken up after the stem-cell procedure in hospital singing ‘It's Coming Home’.

Euro 2020 sponsor Vivo said it wanted to thank Mr Astley for ‘his selfless lifesaving donation’ and had arranged for him and his girlfriend to attend the final match of England against Italy as its guests. ‘We hope that both of them enjoy the experience’, the Chinese smartphone manufacturer added. Incidentally, after a penalty shoot-out in extra time, Italy won the final 3 - 2. Stem-cell treatments also won.

Miscellaneous

Nuala Scarisbrick (1939 – 2021)
In 1970, Nuala and Jack Scarisbrick co-founded LIFE - Save the Unborn Child. It was to become the largest and most influential pro-life charity in the UK. Informed by their Roman Catholic faith and influenced by some of their friends, they had come to realise that the 1967 Abortion Act was an iniquitous piece of legislation and that they had to do something to counter its adverse effects. They were adamant that declaring to be against abortion was not enough – positive, practical alternatives were needed. There could be no circumstances that justified aborting an unborn child. Consequently Life took an absolutist stance. Thousands and thousands of women and their children are thankful that the Scarisbricks and Life have supported and defended them through difficult and unexpected pregnancies.

In the early days, Nuala and Jack were caring for pregnant girls by taking them into their own home. While Jack became the figurehead of the new charity, it was Nuala who oversaw the day-to-day running of Life. For 30 years, she took on the full-time but unpaid position of National Administrator. Jack described her as Life’s ‘chief animator’. The husband-and-wife team became the dynamic duo who drove the charity until they stepped down from their leadership roles in 2017. By then Nuala had begun to experience the onset of Alzheimer's.

And how thankful many of us are to have known Nuala, for so many years, the châtelaine of Life House, the matriarch of the Life family and the doyenne of all things pro-life. To know her was to admire her. Tireless defender of the unborn, formidable organiser, generous hostess, steadfast friend, gifted teacher, wellspring and driver of ideas, fount of fun.

Nuala was a great encourager. In the early 1980s, many of us, educated by the Schaeffer and Koop book and films, entitled Whatever Happened to the Human Race? were looking for an outlet to express our new-found pro-life credentials. Nuala cheered us on to form Evangelicals for Life, a specialist grouping within the main organisation. It helped broaden the UK’s pro-life constituency so that being anti-abortion was no longer only a Roman Catholic endeavour.

She was also a formidable realist – when we told her we wanted to start the Aberystwyth Life Group, her response was that nonchalant, ‘Oh, you want to give it a go do you?’ but then reassuringly she drove from Leamington Spa to Aberystwyth to spend a weekend training us in Life education, caring and political advocacy. She was almost Wonder Woman!

Nuala Ann Scarisbrick (née Izod) was born in January 1939 at St Thomas’s Hospital, London and lived in Ewell, Surrey. She attended Rosebery Grammar School for Girls in Epsom. After university, she worked first for Unilever, helping to launch the washing powder 'Daz', and then briefly as an English literature teacher in Reigate, Surrey. In 1965, she married the distinguished Tudor expert, Professor John Joseph ‘Jack’ Scarisbrick. They first met when she got into the same carriage of the Epsom/London train one morning when Jack was on his way to Queen Mary College, where he was teaching. Nuala was going to University College, where she was studying English literature. She had a pile of books in her arms which she spilled across the seat and floor when the train started. Jack helped her recover them. They did not exchange more than a few words – Nuala had immediately plunged herself into one of the retrieved books. They met ‘properly’ at a smart cocktail party in Chelsea many months later. Jack spotted her at the far corner of a crowded room and managed to weave his way over to her - to introduce himself. He had not remembered that they had already ‘met’.
Her first words to him were ‘Have you got a clean shirt on?’ He probably hadn’t! But as Jack recalled, 'I fell for her totally. What young(ish) man wouldn’t?' Three months later we were married.

They made their home in Leamington Spa. They have two daughters, eight grandchildren, and ten great-grandchildren. How we loved her – how we will now miss her. Our heartfelt condolences go to Jack and the family – how especially privileged they were to have known Nuala for decades as wife, mother, grandmother and great-grandmother. She died at home in August 2021, surrounded by Jack and their daughters.

Biological and chronological clocks
How old are you? Some reply with a chronological age. Some say they are only as old as they feel. The better informed declare they are as old as their arteries. Welcome to the inflammatory ageing clock (iAge). This is a new type of ‘clock’ that can assess chronic inflammation to predict whether someone is at risk of developing age-related disorders, such as cardiovascular and neurodegenerative diseases. The clock measures a person’s ‘biological age’, which takes health into consideration and can therefore be higher or lower than a person’s chronological age. Healthy people tend to have a biological age lower than their chronological age.

It has been described in a paper entitled, ‘An inflammatory aging clock (iAge) based on deep learning tracks multimorbidity, immunosenescence, frailty and cardiovascular aging’ by Nazish Sayed et al., in Nature Aging (2021, 1: 598-615).

The concept behind the iAge is based on the idea that as a person ages, their body experiences chronic, systemic inflammation – their cells become damaged and emit inflammation-causing molecules. This ultimately leads to wear and tear on their tissues and organs. And because people with a healthy immune system will be more able to neutralise this inflammation, they will age more slowly. In other words, because inflammation is treatable, the iAge tool could help doctors determine who would benefit from medical intervention, such as anti-inflammatory drugs, that should potentially extend the number of years a person lives in good health.

To develop iAge, the team at Stanford University in California analysed blood samples from 1,001 people aged 8 to 96 years old. The researchers used health information and a machine-learning algorithm to identify protein markers in blood that most clearly signalled systemic inflammation. In particular, they pinpointed the immune-signalling protein, or cytokine, CXCL9. It is mainly produced by the inner lining of blood vessels (including arteries!) and has been associated with the development of heart disease.

The researchers tested iAge on a cohort of centenarians. The results showed the volunteers had on average a biological age 40 years younger than their chronological age. This further suggested that people with healthier immune systems tend to live longer. Measuring inflammation with the iAge clock could prove to be a useful predictor of patient health in a clinical setting.

Conscientious objection reversed
Talk about abortion or euthanasia and the issue of conscientious objection is never far away. Not long ago, it was simple. For example, Section 4 of the 1967 Abortion Act protected the ethical stance of healthcare workers by stating that individuals are under no obligation to ‘participate in any treatment authorised by [the Act] to which [they have] a conscientious objection.’ It has become a highly-contested and poorly-resolved piece of legislation.

Nowadays, it is more commonly argued that doctors have a duty of care to provide legal healthcare services. Take, for example, an article by Kyle Fritz, of the University of Mississippi, in The American Journal of Bioethics (2021, 1: 46-59), entitled ‘Unjustified symmetry: Positive Claims of Conscience and Heartbeat Bills.’

Interestingly, the legal code of Fritz’s home state, Mississippi, declares, ‘A health-care provider may decline to comply with an individual instruction or health-care decision for reasons of conscience.’ Fritz argues, quite unconvincingly, that if some doctors are permitted to withhold their services on the grounds of conscientious objection, why cannot other doctors provide their services for the same reason? He calls the current situation ethically ‘asymmetrical’.

Fritz writes, ‘… one’s integrity can be damaged not only by performing an action contrary to one’s conscience, but also by not performing an action that one’s conscience requires. So, if we should protect negative conscience clauses to protect integrity, we should also protect positive ones for the same reason.’

Fritz’s approval is long and complex. The objection is more concise. If an act is deemed legal, say abortion, then a negative conscience clause is a performance of charity. The act can be performed by another. If an act is deemed illegal, say euthanasia, then a positive conscience clause is a performance of unlawfulness. And the law should never encourage that which is illicit.

What would be the outcome of implementing Fritz’s thesis? If both negative and positive conscience clauses are allowed, then conscientious objection becomes meaningless.

USA and Elsewhere

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

UPitt admits conducting ‘fetal tissue research’ ... ‘obtained from repositories called tissue banks’ and that it ‘receives all fetal tissues from UPMC (University of Pittsburgh Medical School) Magee-Womens Hospital.’ However, the University denies any illegal activities. David Seldin, UPitt’s vice chancellor for news has stated, ‘As we have repeatedly noted, the University of Pittsburgh does not perform medical procedures and is not part of the tissue collection process. All of the University’s research is closely supervised to ensure compliance with strict and rigorous federal and state laws and regulations.’

Counter evidence has come from documents obtained from the US Department of Health and Human Services through a Freedom of Information Act request. The documents are purported to show that the federal government gave the University of Pittsburgh at least $2.7 million over the last five years to become a ‘tissue hub’ for aborted baby body parts for scientific research.

Such has been the media pressure that the University has recently retained the Washington DC law firm of Hyman Phelps & McNamara to prove its research is legal. Moreover, state senators plan to introduce legislation to instruct the Pennsylvania Auditor General, Timothy DeFoor, and the Attorney General, Josh Shapiro, to inspect the University. In the meantime, the investigations, allegations and denials continue.

Francis Collins steps down
In early October, the 71-year-old Francis Collins announced that he will step down as director of the US National Institutes of Health (NIH) by the end of the year. He said, ‘This is the right time, it’s the right message, it’s the right decision.’ Collins has led the US$41-billion biomedical agency through this historic and deadly pandemic with courage and aplomb. Appointed by then-president Barack Obama in 2009 and serving under three US presidents, Collins has held the NIH role for longer than any other presidential appointee.

Collins is renowned as a world-class geneticist. Moreover, he has built a reputation as a savvy spokesperson for scientific research, winning supporters across party lines. Throughout the politically-charged Covid-19 pandemic, he has been on the frontlines urging Americans to wear face coverings and get vaccinated.

He is sure his resignation decision is right. He has been quoted as saying, ‘I’m not worried that if I walk away by the end of the year, that will do any serious harm to our contribution to fighting this pandemic.’ And ‘I am proud of all we’ve accomplished. I fundamentally believe, however, that no single person should serve in the position too long, and that it’s time to bring in a new scientist to lead the NIH into the future.’

Besides his scientific credentials, Collins has been known as an outspoken conservative evangelical Christian. He has spoken often and at length about his conversion from atheism to Christianity. In 2006, he wrote a book entitled, ‘The Language of God: A Scientist Presents Evidence for Belief.’ The following year, he founded, with his wife, Diane, The BioLogos Foundation, a group that aims to reconcile religion and science and argues that God created the world through evolution. That ruffled many feathers among many evangelicals. In addition, he has drawn the ire of pro-life groups because of his support for using foetal tissue in medical research.

Yet his robust Christian character and winsomeness are undeniable. A typical example of his sweet bluntness are seen in a recent statement in reference to the Covid-19 vaccines. ‘For somebody who’s a believer, this is what you could call an answer to prayer. If we’ve all been praying to God to somehow deliver us from this terrible pandemic, and what happens is these vaccines get developed that are safe and effective, well, why wouldn’t you want to say, “Thank you, God” and roll up your sleeve?’ Last month, he admitted that he is ‘a bit’ frustrated with fellow evangelicals who have hesitated or refused to get vaccinated.

Happy, productive retirement, Francis.

Euthanasia in Australia
Talk about group membership, peer pressure or slippery slopes reminds us that we are all influenced by those around us, for good or ill. And it seems to be the trend in euthanasia legalisation.

Take, for example, the Commonwealth of Australia. A country of 26 million people spread out over six states. By contrast, the United Kingdom is a country of 60 million people spread out over four countries. Yet we speak the same language, sort of.

But, as yet, we do not share the same bioethical values, especially in terms of euthanasia and assisted suicide. Both remain illegal in the UK. By contrast, euthanasia legalisation has ripped through Australia in less than five years. A convenient starting point would be the 1997 Euthanasia Laws Act. This removed the power of Parliament to legalise euthanasia in the states. And so they fell, not en masse, but one by one, and rapidly, just like a clique of dominoes. First was Victoria in 2017 followed by Western Australia in 2019. The law in these two states is now operational. Then, this year, the bioethical momentum moved up a gear with legalisation in Tasmania in March 2021, followed by South Australia in June 2021 and Queensland in September 2021. The killing will start in these three states within the next two years. So, now there is only one Aussie outsider, New South Wales.

The legalisation of euthanasia is like a contagion – it travels down that slippery slope, passing from neighbour to neighbour. Who would bet against New South Wales not joining the gang within the next two years? Already in mid-October, Alex Greenwich, a New South Wales independent MP, has tabled his Voluntary Assisted Dying Bill 2021.

Extrapolate to the UK. So far, the four countries have firmly resisted assisted suicide legislation. But euthanasia bills are currently before the parliaments at Westminster and Holyrood. What will stop them? Who will stop them?

Abortion in Benin
Faced with a map of the world could you (honestly) put your finger on Benin? That’s it, sandwiched between Nigeria and Togo, the French-speaking land of 12 million people. Well, if you can’t find it, abortion certainly can.

In mid-October, after a heated debate, Benin’s parliament voted to legalise abortion in most circumstances. Benin therefore become one of only a handful of African countries to do so, including Zambia, Cape Verde, Mozambique, South Africa and Tunisia. By contrast, several countries in Africa have total bans on abortion, including Congo-Brazzaville, the Democratic Republic of Congo, Djibouti, Egypt, Guinea-Bissau and Senegal. Abortion in Benin was previously legal only in cases of rape, or incest, or if the mother’s life was at risk, or if the unborn child had a particularly serious medical condition.

The new law says abortion may be permitted in the first 12 weeks of a pregnancy if the pregnancy is ‘likely to aggravate or cause a situation of material, educational, professional or moral distress incompatible with the interests of the woman and/or the unborn child.’ However, the law still needs to be ratified by the constitutional court before it can take effect.

According to Benin’s Health Minister, Benjamin Hounkpatin, ‘This measure is going to ease the pain of many women who, faced with the distress of an unwanted pregnancy, find themselves obliged to risk their lives by using unsafe abortion methods.’ He estimated that unsafe abortions are responsible for 20% of maternal deaths across his country. However, the truth is that abortion should never be regarded as healthcare.

Abortion in El Salvador
Keep that map of the world open. Now put your finger on El Salvador. There it is, in South America, bordered by Honduras and Guatemala, with a population of 6.5 million. See, this is not just an ‘Update on Life Issues’!

The El Salvador constitution contains a right-to-life article, passed in 1998. It recognises ‘as a human person every human being from the moment of conception.’ The country has one of the world’s strictest laws on abortion. Elective abortion is banned in all cases, including rape, incest and foetal deformity. The penalty for mothers and for doctors is between 2 and 8 years in prison. El Salvador is under immense international pressure, from Western governments, international groups and NGOs, to liberalise its ban on abortion.

In mid-October, the Salvadorian Congress voted overwhelmingly, 73 to 11, to maintain its current law. The vote was in response to a petition brought in September by women's rights groups, seeking exceptions to the abortion ban.

After the vote, Rebeca Santos, congresswoman for the ruling New Ideas Party, declared, ‘We have legislated in favour of protecting life from its conception.’ Again, abortion should never be regarded as healthcare.

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