Update on Life Issues - February 2016

Abortion in Northern Ireland
Northern Ireland is part of the UK, but also not part of the UK.  For instance, the 1967 Abortion Act has never been extended to Northern Ireland.  Abortion there remains a crime under the 1861 Offences Against the Person Act, by which offenders can face a maximum penalty of life imprisonment.  Abortion in the Province may be carried out only if a woman's life is deemed to be at risk, or if there is a permanent or serious risk to her mental or physical health.  This is an uncommon occurrence – official statistics show that only 23 such terminations took place there in 2013-14.

In recent years, this strict state of affairs has become the focus of protest.  Organisations, such as Marie Stopes and Amnesty International, have joined the campaign to liberalise the law.  The battle has been intense.  In 2014, the Northern Ireland's Department of Justice carried out a public consultation on changing the law to allow abortion in cases of fatal foetal abnormality.  The Northern Ireland Human Rights Commission considered this move too limited and therefore brought a legal challenge to extend abortion to cases of serious foetal malformation, rape and incest.  A judicial review hearing was held over three days in June 2015.  On 30 November 2015, Mr Justice Horner, a Belfast High Court judge, ruled that Northern Ireland’s abortion legislation is in breach of Article Eight of the European Convention on Human Rights.  In other words, some women are entitled to exemptions in the law.  It is still unclear whether new legislation by the Stormont Assembly will be required to enforce this ruling.  Nevertheless, many consider there is no public appetite for a change to the current law.  In late January 2016, both the Attorney General for Northern Ireland and the Minister for Justice announced their intentions to appeal, for different reasons, the High Court ruling.

Abortion in Scotland
The 1967 Abortion Act does apply to Scotland.  Therefore the upper time limit for most abortions stands at 24 weeks.  Now there are fears that this limit could be extended if, and when, abortion law is devolved from the UK Parliament under the pending Scotland Bill, which has been introduced as a result of the failed 2014 independence referendum. The Bill began its Committee Stage in the House of Lords on 19 January 2016.

To oppose any potential extension of time limits for abortion, a new campaign organisation has been launched called, Don’t Stop a Beating Heart.  The group’s message is that, ‘there is always a better solution than abortion’, ‘abortion damages women’ and ‘abortion discriminates against babies with disabilities’.  Despite the fears, Scotland’s First Minister, Nicola Sturgeon, has already stressed that her SNP government will make no changes to the law.

Dr Palaniappan Rajmohan
In 2014, undercover reporters from The Daily Telegraph caught Dr Palaniappan Rajmohan on video willing to perform a sex-selective abortion.  In February 2015, MPs defeated, by 292 votes to 201, an amendment, introduced by Fiona Bruce MP, that would have made sex-selective abortions illegal under UK law.

In November, Rajmohan was disciplined, not for his willingness to kill an unborn child because of her sex, but because he lied on government paperwork.  He admitted falsely recording that Ms A wanted a termination because she was ‘too young for pregnancy’ when she had told him that her real reason was the sex of the foetus.

Paul Curtis, who chaired the UK Medical Practitioners Tribunal Service (MPTS) hearing, wrote, ‘The panel is in no doubt that your actions have brought the medical profession into disrepute and would be considered deplorable by fellow practitioners.  As such, the panel is satisfied that your conduct is sufficiently serious as to amount to misconduct.  The panel has determined it is in the public interest to suspend your registration with immediate effect in order to maintain public confidence in the profession.’  And what was Dr Rajmohan’s punishment?  Three month’s suspension from practice.  A mere slap on the wrist.

    Update - the MPTS ruled in January that Dr Rajmohan's fitness to practise was no longer impaired. 
In other words, though his ban will remain on the public record, he is now free to continue to perform abortions.

Yet another test for Down’s
The UK National Screening Committee (UKNSC) has recommended that a new non-invasive test for Down’s syndrome forms part of the NHS’s Fetal Anomaly Screening Programme (FASP) in England.  If the government approves the change it will mean fewer women will need to undergo invasive diagnostic tests, such as amniocentesis, which carry a small associated risk of miscarriage.

The new Non-Invasive Pre-natal Testing (NIPT) is based on cfDNA screening.  The test involves collecting a sample of a pregnant mother's blood, isolating fragments of cell-free DNA (cfDNA) and screening them for genetic abnormalities.  The majority of the fragments come from the mother (cell-free maternal DNA), but around 10% to 20% come from the unborn child (cell-free foetal DNA).  If the unborn child has Down’s syndrome there will be proportionally more chromosome 21 fragments than expected because Down’s people have two copies of this chromosome.

If approved, it would be offered as an additional test for Down’s syndrome plus three other common aneuploidies, Edward’s, Patau’s and Turner’s syndromes.  Currently, women between 10 and 14 weeks’ gestation, and considered to be at ‘high risk’, are offered invasive screening for these genetic anomalies.  NIPT can be optimally used by week 10.  It is reckoned to detect at least 98% of Down’s pregnancies.

At present, at least 90% of unborn children who are prenatally diagnosed with Down’s syndrome are aborted.  If the new cfDNA test were implemented it is estimated that it would detect another 102 Down’s babies each year, of which 92 would likely be aborted.  On the other hand, it is projected that the NIPT would prevent 25 miscarriages caused by the old invasive tests.

However, a recent review by the Department of Health found that NIPT is also being used to determine a baby’s sex, which could lead to an increase in sex-selective abortions.  The review stated that any such misuse of NIPT, ‘underlines the need for us to continue to monitor birth ratios and abortions by ethnicity to assess the impact of these tests, particularly if they become more widely available.’  NIPT, which can be carried out as early as 7 weeks into a pregnancy, is not yet available on the NHS, but some private clinics, in conjunction with US centres, are offering the test at between £400 and £900.

Don’t Screen Us Out
And what is the reaction to all this among some Down’s adults?  They are appalled.  In January 2016, a new campaign group, Don’t Screen Us Out, was launched after the UK National Screening Committee (UKNSC) released its decision to recommend the implementation of the non-invasive prenatal testing (NIPT) technique called ‘cell-free DNA’ (cfDNA), which could lead to a profound reduction in the number of children born with Down’s syndrome.

The group warns that the new test will, ‘... enable a kind of informal eugenics in which certain kinds of disabled people are effectively “screened out” of the population before they are even born.’  The Don’t Screen Us Out organisation calls on the UK government to halt the implementation of cfDNA screening and to introduce reforms which would more effectively support those with Down’s syndrome and their families.

In October 2015, the UNESCO International Bioethics Committee issued a strong warning on the ethical implications of approving NIPT.  The Committee’s report stated, ‘A widespread use of NIPT, namely as general screening in order to detect abnormalities, followed by an abortion, is perceived by some people as an evidence of the will to avoid permanent pain in a lifetime, by others as a sign of a situation of the exclusion society gives to people affected by this illness, meaning indirectly that certain lives are worth living, and others less.’

China’s new two-child policy
On 29 October 2015, the Chinese government announced that it would end, or at least modify, its decades-long one-child policy.  All couples would now be allowed to have two children.  The controversial policy was introduced in 1979 to reduce the country's birth rate and slow its population growth rate.  The policy was mostly managed through a series of birth permits, compulsory sterilizations and forced abortions – often carried out brutally.  In 2012, the Chinese government announced that the one-child policy had prevented 400 million births, including 336 million abortions, which corroborates evidence from other sources that the abortion rate in China has been about 13 million each year.

The new policy has been introduced progressively.  For several years China has allowed ethnic minorities and couples in rural areas, whose first child is a girl, to have a second child.  And in 2013, couples, where at least one spouse was an only child, were permitted to have a second child.

But the legacy of the old policy is all too evident.  Traditional family life has become restricted with too many overindulged ‘boy emperors’.  There is also an ageing population, creating a dangerously imbalanced demographic spiral.  The Chinese workforce will lose 67 million people during the next 15 years with estimates that a quarter of its population, 440 million people, will be over 60 by 2050.  And because of widespread abortion or infanticide of girls, there are now an estimated 20 to 40 million eligible Chinese men unable to find brides.  This demographic distortion has fuelled an increase in sex crimes and a growing sex-trafficking industry.

Even the new policy has its stern critics.  In Beijing, government officials have apparently already denied 5,000 couples the freedom to have a second child.  Others criticise the authorities because the new measures still retain a system of forced abortions and government-controlled fertility regulations.  Moreover, enforced quotas and systems of surveillance are ever present.  And severe penalties remain for those who dare to have a third child.

The UK’s new two-child policy
The UK government’s proposed new policy, announced in the 8 July budget, will impose a two-child limit on tax credits and housing benefits.  The policy, to be introduced in April 2017, has been condemned as ‘fundamentally anti-family’.  Others consider it could split up families as well as put pressure on people trapped in abusive households.  Moreover, there have been warnings that it could lead to more abortions.

Gene Editing
The development of gene editing
The age of genetic engineering arguably began in 1973 when scientists in California developed recombinant DNA techniques that allowed the insertion of new genes into living cells.  But it was a hit-and-miss technology.  At the turn of this century, we were told that gene therapy would change the world.  It did not.  Patients were ‘infected’ with viruses that contained ‘healthy’ DNA in order to replace their defective or missing DNA.  Sadly, such treatments created their own problems with isolated ‘boys in bubbles’ and a few patients developing leukaemia, or even dying.

Those therapeutic nightmares have now become therapeutic dreams, almost.  In the last few years, those old unpredictable methods have been replaced by the elegant, precise – and contentious – techniques of gene editing.  There are currently three basic technologies, known as zinc fingers, TALENs and CRISPR.  They act similarly as a type of satnav that guides its way to a specific site on the DNA chain and then an associated enzyme, behaving like a pair of ‘molecular scissors’, edits the DNA – cuts it out and splices it in, anywhere and everywhere, and easily, and cheaply.  These radical gene-editing techniques have opened up a whole new therapeutic world – it is still genetic engineering, but this time, so much more nifty.

No topic has dominated the chattering world of biological science during the last year as much as gene editing.  While it is universally regarded as ‘the biggest biotechnology advance’ for decades, its possibilities have divided both the scientific and the bioethical domains.  It has raised again that age-old problem of ‘we can, but should we?’  Specifically, should we edit the human genome and begin to engineer human beings?

We already ‘engineer’ our offspring, albeit crudely.  Who we choose to reproduce with is a form of selective editing.  Preimplantation genetic diagnosis (PGD) is a recognised method of choosing some embryos to live and some to die.  But gene editing raises other concerns.  For instance, is it safe technically and socially?  There may be unintended side effects – certainly it is a novel and untried technology.  It is also capable of producing germline modifications – genetic changes that are passed down the generations of offspring without their consent.  Yet, if gene editing can help the millions born each year who are disabled for life, is consent even relevant?  Yet, if allowed, where will the slippery slope of genetic tinkering end – medical treatments, physical and mental enhancements, or out-and-out eugenics?  Will we come to regard people as mere carriers of genetic information rather than as persons with individual intrinsic dignity and value?  It has been said that gene editing ‘has the potential to completely wipe out diseases, but also that to wipe out humanity.’

And consider its phenomenal development.  Currently the major technique for gene editing is CRISPR-Cas9.  CRISPR is shorthand for Clustered Regularly-Interspaced Short Palindromic Repeats.  Cas9 is an enzyme which acts as the 'molecular scissors'.  It was only in 2012 that Jennifer Doudna and Emmanuelle Charpentier discovered that CRISPR and Cas9 could ‘cut and paste’ genes and genomes.  And it was only in April 2015 that Huang and his colleagues in China first used the procedure to edit the genomes of human embryos.

Whatever the pros and cons, the gene-editing race is on – it will not go away.  Gene-editing methodologies may come and go, but the momentum of this technique is unstoppable.  At the end of 2015, the journal Science awarded CRISPR the Breakthrough of the Year Award.  A recent Thomson Reuters’ analysis of hot research topics noted that of the ten most cited research papers of 2015, three involved CRISPR.  And gene-editing start-up companies have popped up worldwide as a result of gigantic financial investments.  For example, in August 2015, Google and other investors ploughed $120m into a genome-editing enterprise, Editas Medicine, in Cambridge, Massachusetts.  A Nobel Prize must surely be in the offing.

Incidentally, there is currently ‘a humungous biotech patent dispute’ over who owns the intellectual property rights to CRISPR-Cas9.  The outcome of recent submissions to the US Patent and Trademark Office could be worth millions to the research institutions that are at war over the relevant patents.  Jennifer Doudna and Emmanuelle Charpentier filed a patent application on 15 March 2013.  But other groups have since improved and applied the technique.  For instance, Feng Zhang of MIT filed a patent application for the CRISPR–Cas9 technique in October 2013, which was granted in April 2014.  If CRISPR-Cas9 were to become a licensed technology, the expected revenue could be substantial.  Meanwhile, the original Doudna–Charpentier patent remains under review.  The claims and counter-claims continue.

However, note carefully that not all gene editing need be bioethically disturbing.  It may have enormous potential to treat, or even cure, some genetic diseases in adult human beings, where clearly it is not a form of germline therapy.  The first example of this sort of bioethically-acceptable treatment has been that of one-year-old Layla Richards, who in 2015 was dying from leukaemia after all conventional treatments had failed.  Gene-edited immune cells, known as T-cells, specifically engineered as UCART19 cells, were used to treat her at Great Ormond Street Hospital.  It is too early to say if she is cured, but she is now alive and well.  Such gene-editing treatments are not the problem.  The dilemma comes when human embryos are subjected to gene editing – that is germline therapy, embryo destructive and highly controversial.

The Washington pow-wow
Is there any hope for a global consensus on gene-editing regulation?  From 1 to 3 December 2015, almost 500 scientists, bioethicists and legal experts from more than 20 countries gathered in Washington DC to consider this and other related questions at the so-called International Summit on Human Gene Editing: A Global Discussion.

It concluded that basic and pre-clinical gene-editing research should be allowed – even in human gametes and embryos, but that ‘the modified cells should not be used to establish a pregnancy.’  It was also agreed that gene editing could be used for clinical applications to treat diseases in human non-germline cells that cannot be inherited, such as blood and immune cells.  However, germline editing, either to remove inherited diseases and stop them being passed onto future generations, or to enhance human capabilities, was considered to be too risky.  It was decided that these agreements should be ‘revisited on a regular basis’ and an international forum should be created.  Can anyone seriously believe that this is anything other than the recognition that a slippery slope is real and threatening?  But slopes stop nothing – quite the opposite, they speed up descent.  Only tough laws, moral barriers and agreed moratoria can stop bad practices.

Gene editing comes to Britain
Meanwhile, gene editing of the human embryo has come to Britain.  In September 2015, a team at the Francis Crick Institute in London, headed by Kathy Niakan, applied to the HFEA for a licence to use gene editing to shed light on the early stages of life, reduce miscarriages and potentially improve fertility treatments.  Niakan stated, 'We would really like to understand the genes needed for a human embryo to develop successfully into a healthy baby.  The reason why it is so important is because miscarriages and infertility are extremely common, but they're not very well understood.’  This is an odd proposal since the majority of embryonic implantation failures and subsequent miscarriages are caused by chromosomal abnormalities, not single gene defects as Niakan wishes to study.  But anything involving the improvement of infertility – the essential so-called ‘therapeutic benefit’ – catches the ready ear of the popular media.  And many scientists have learned that a little hype goes a long way towards obtaining regulatory approval – remember those puffed-up, but eventually successful, calls for human-admixed embryos and ‘three-parent’ IVF.

Using the CRISPR-Cas9 genome-editing technology, Niakan and her team plan to run a pilot study in which the Oct4 gene will be knocked out of human zygotes in order to assess its role in the developing embryos.  Next, they intend to ‘turn off’ up to four genes in human zygotes and establish if they are crucial for the subsequent development of the embryos.  A total of about 120 embryos, donated as ‘spares’ from IVF, will be used and, after about 7 days, will, of course, be destroyed.  The HFEA met to consider this application on 14 January 2016.  A decision was promised shortly.  In another context, I have already vowed to eat my hat if the HFEA refuses to grant the licence.

Dr David King, the director of the campaign group Human Genetics Alert, has said, ‘This is the first step on a path that scientists have carefully mapped out towards the legalisation of GM babies.’  Yet the level of policymakers’ support for human gene editing can be gauged from a recent speech by Professor Sir Mark Walpert, the government’s Chief Scientific Adviser.  He maintained that the knowledge we will gain from human genetic editing – along with the responsibly to prevent suffering from life-threatening conditions – means that the UK should be leading such discussions about embryo engineering.  And, no doubt, also the practice thereof.

And so it came to pass that on 1 February, the HFEA duly granted the aforementioned licence.  Somewhat strangely, nothing was announced on the HFEA's website until 3 February.  Yet this is the first time any country has considered the DNA-altering technique in human embryos and afterwards approved it.  Another first for the UK.  The experiments could start within a few months.  Sadly, my hat is preserved!

Assisted Reproductive Technologies
Battling over frozen human embryos
This is not a new type of battle.  Couples who use IVF often produce ‘spare’ embryos.  They are typically frozen, the couple falls out or divorces and the ‘ownership’ of the embryos is disputed.  Off to court the couple goes.

There are hundreds of such stories – most never make the news, but some do.  Take, for instance, the recent case of Jalesia McQueen and Justin Gadberry, a divorced Missouri couple in a court battle over the frozen embryos left over after the birth of their twins through IVF.  Mr Gadberry wants no more children with his ex-wife.  She cannot use the embryos without her former husband’s consent.  She has stated, ‘This is the thing that kills me – having to fight to get my own children.’

Previously, most courts have treated embryos as marital property, frequently favouring the party who plans not to use the embryos, emphasizing a 'right' not to be forced to procreate.  In the Missouri case, pro-life groups have now interceded on behalf of Jalesia McQueen.  They have argued that such cases should be decided according to the best interests of the embryos, the same legal standard used in child-custody disputes.  They say that it is in an embryo’s most fundamental interest to be born – ‘No other right is of any avail if a human being is not around to invoke it.’

All parties will undoubtedly be in and out of Missouri courts in the coming months.  It is noteworthy that it was a Missouri court which produced the infamous judgement in the 1857 Dred Scott case, namely that a slave was not a citizen, but property.  159 years later, the Missouri court system has another chance to right another wrong.  Are these embryos to be regarded as property, or will they be presumed to be human beings?

A similar tangle, but in different circumstances, is the much-publicized Californian case concerning two frozen embryos the actress Sofía Vergara created with her ex-fiancé, Nick Loeb.  He regards the embryos as his twin daughters and wants them transferred to a surrogate.  Ms Vergara’s request to dismiss the case has recently been denied, but no trial date has been set.  IVF can be mighty troublesome.

Battling over IVF-surrogate babies
IVF and surrogacy can be doubly troublesome.  Here is yet another novel example of what can go wrong.  In December 2015, an Israeli gay couple collected their baby daughter from an IVF-surrogate arrangement in Nepal.  On returning to Israel, genetic tests showed that she was related to neither of the men.  They went back to Nepal to hand her over to a heterosexual couple.

Surrogacy is prohibited in Israel for gay couples and Nepal has recently declared a moratorium on the practice.  The reporting of this particular sort of tangle may be new, but how many other such mix-up cases exist?  Hearsay evidence suggests that it is not uncommon.  But without genetic testing, such cases will never be uncovered.  Incidentally, as well as Nepal, now India and Thailand have banned international clients from using local surrogates.

Family dynamics after donor insemination
As I’ve said/written before, ‘You could not make this stuff up.’  In 2001, a girl was born as a result of donor insemination.  In 2005, her sister was similarly conceived and born.  Since their births, both girls have been brought up by their biological mother and the mother's lesbian partner.  Seven years ago, their biological father, who is in a civil partnership with another man, petitioned the courts to have contact with his daughters.  A long-running legal battle ensued, which the girls say has ruined their childhoods.

In October 2015, at the High Court in London, Mr Justice Cobb ordered that the now 14 and 10-year-old girls have ‘indirect’ and ‘limited’ contact with their two ‘fathers’, even though it is against the girls' wishes.  The Judge said, ‘I remain clearly of the view that the fathers have something of real value and importance to add to the lives of the girls.'  He also added that the case illustrated the 'immense difficulties' which could be 'unleashed' when families were created by 'known-donor fertilisation'.

Surrogacy in Europe condemned
In December 2015, the European Parliament acted to condemn all forms of surrogacy.  It adopted the 'Annual Report on Human Rights and Democracy in the World in 2014.'  The relevant wording is contained in Paragraph 114, namely, that the European Parliament, ‘Condemns the practice of surrogacy, which undermines the human dignity of the woman since her body and its reproductive functions are used as a commodity; considers that the practice of gestational surrogacy which involves reproductive exploitation and use of the human body for financial or other gain, in particular in the case of vulnerable women in developing countries, shall be prohibited and treated as a matter of urgency in human rights instruments.’  Tough words indeed.

AneVivo and IVF
The privately-run Complete Fertility clinic in Southampton is the first in the UK to offer a new form of IVF treatment, the AneVivo device method.  It is a tiny tubular capsule that is loaded with sperm and ova before being placed into the uterus.  It is said that it allows fertilisation to occur in the natural environment of the womb rather than in a Petri dish in the laboratory.  The device has been approved by the HFEA even though it is not known if it brings any benefits.  International trials in around 250 women suggested that it achieves a similar pregnancy rate to conventional IVF.  So why would anyone use it when it costs around £700 a go?

Although AneVivo seeks to mimic natural fertilisation, any resulting embryos still need to be removed from the device and given a health check in the laboratory before being transferred back into patients.  The technique is reminiscent of the old, and now largely-abandoned, method of GIFT (gamete intra-fallopian transfer), whereby the gametes were mixed and placed in the Fallopian tubes to allow normal fertilisation to occur in utero.  AneVivo necessitates even more meddling.

Stem-Cell Technologies
Diabetes and adult stem cells
Diabetes is now a major public health problem that is approaching epidemic proportions with 400 million sufferers worldwide, including 3.9 million in the UK.  Moreover, diabetes is the most common cause of end-stage kidney disease – it kills around 40,000 people in the UK each year.

A novel treatment for high-risk patients is based on injecting a product called ORBCELL-M, which is derived from mesenchymal stem cells (MSCs) grown from donated bone marrow.  NHS Blood and Transplant has set up a stem-cell factory in Liverpool to supply this product to be used in a clinical trial with 48 type-2 diabetic patients in Birmingham, Belfast, Ireland and Italy.  It is part of the NEPHSTROM (Novel Stromal Cell Therapy for Diabetic Kidney Disease) project.  Though not a cure, it is hoped that this therapy will reduce kidney inflammation and damage, improve renal function and remove the need for dialysis.  It is thought that the transplanted stem-cell material releases soluble compounds, such as growth factors and immunomodulatory substances, which contribute to tissue repair and regeneration.

And more good news for kidney patients
In October 2015, Nature published a paper (526: 564-568)
by Minoru Takasato and colleagues entitled, ‘Kidney organoids from human iPS cells contain multiple lineages and model human nephrogenesis.’  The human kidney is composed of at least 20 different cell types that perform functions such as excretion, pH regulation, as well as electrolyte and fluid balance.

This Australian group had previously reprogrammed induced pluripotent stem cells (iPSCs) to produce functional kidney organoids.  In their latest paper, building on this knowledge, they ‘... generated kidney organoids that contain nephrons associated with a collecting duct network surrounded by renal interstitium and endothelial cells.  Within these organoids, individual nephrons segment into distal and proximal tubules, early loops of Henle, and glomeruli containing podocytes elaborating foot processes and undergoing vascularization.’  In other words, their organoids were physically and functionally like human foetal kidneys.  The authors concluded that, ‘Such kidney organoids represent powerful models of the human organ for future applications, including nephrotoxicity screening, disease modelling and as a source of cells for therapy.’  How long will it be before kidney transplants are a thing of the past?

Are iPSC and hESC similar?
Herein is a long-running argument – are human induced pluripotent stem cells (hiPSCs) and human embryonic stem cells (hESCs) functionally equivalent?  Certainly they are not bioethically equivalent since the latter can only be sourced by the destruction of human embryos.

The October issue of Nature Biotechnology published (33: 1173-1181) new evidence from researchers at the Harvard Stem Cell Institute (HSCI) that some iPSCs do indeed function just like the embryonic variety.  The article by Konrad Hochedlinger and his colleagues was entitled, ‘A comparison of genetically matched cell lines reveals the equivalence of human iPSCs and ESCs.’

To make a valid comparison the Harvard group started with genetically identical cells – any functional variations seen would then be due to the reprogramming of the iPSCs.  So they tricked hESCs to become skin cells and then reprogrammed the latter into iPSCs.  Both cell types were then genetically sequenced.  The group found only about 50 of the 20,000 genes that make up the human genome were expressed differently.  These minor differences were regarded as ‘transcriptional noise’.  In other words, iPSCs and hESCs were considered to be genetically equivalent.

The researchers then assessed the two types of stem cells for function.  They were found to have equal potential to differentiate into neural cells and a variety of other specialised cells.  The researchers concluded that, ‘hESCs and hiPSCs are molecularly and functionally equivalent and cannot be distinguished by a consistent gene expression signature.’  Though Hochedlinger still maintains that hESCs are an important ‘reference point’, he also admitted that, ‘... this study increases the "value" of iPS cells.’  Indeed, it increases their suitability for clinical applications.

And even more evidence
In January 2016, Victoria Mascetti and Roger Pedersen published an article with the title, ‘Mouse Chimerism Validates Human Stem Cell Pluripotency’ in Cell Stem Cell, (18: 67–72).  Their basic question was, can human iPSCs be incorporated into embryos and then participate in normal embryonic development?  The answer is yes, at least, in mouse embryos.  The iPSCs differentiated into the three primary tissue layers of the embryo, namely, ectoderm, endoderm and mesoderm.  According to the authors, ‘This faithful recapitulation of tissue-specific fate post-transplantation underscores the functional potential of hiPSCs …’  Come on, bioethically-acceptable iPSCs!

Euthanasia and Assisted Suicide
Assisted suicide law in New Jersey
After California comes New Jersey.  Assisted suicide legalisation is spreading from the West to the East coast of the USA.  The New Jersey legislature is now considering a physician-assisted suicide bill in a bid to launch the New Jersey Aid in Dying for the Terminally Ill Act (Senate Bill 382).  It would allow terminally-ill patients to request life-ending medication.  A 2015 poll showed that nearly two-thirds (63%) of New Jersey residents support giving this entitlement to its terminally-ill patients.

The Bill is badly drafted.  It would not require, in most cases, a psychological examination of the patient before receiving approval for assisted suicide.  It would force pharmacists to supply the lethal prescription.  There would be no investigation process to ensure that the patient actually wants to commit suicide.  And anyone who works for the patient’s medical insurance company could act as both of the required witnesses.  It is a shabby Bill for a shabby procedure.

Is Belgium backtracking?
Is the great Belgian euthanasia machine slowing down, at least, ideologically?  The question arose in 2014, when the serial rapist and murderer, Frank Den Bleeken, who is serving a life sentence, asked to be euthanized.  At first, the government agreed to grant his request, then it refused.  Instead it placed him in a specialised psychiatric unit.

Now 15 other Belgian prisoners have asked for euthanasia on the grounds that they too experience unbearable psychological suffering.  In November 2015, Dr Wim Distelmans, Belgium’s own ‘Dr Death’ and the chairman of the country’s euthanasia commission, declared them ineligible.  He stated that, ‘The unbearable suffering that these prisoners describe is due in large part to the context (that is, prison) and is not the result of an incurable disease.  We have advised the interested parties that they are not within the framework and conditions provided by law.’

Of course, the great Belgian euthanasia machine is not slowing down numerically.  In Belgium during 2015, there were 2,021 reported deaths by euthanasia, up from 1,924 during 2014.

Euthanasia in Canada
In February 2015, the Canadian Supreme Court declared that denying patients access to assisted suicide and voluntary euthanasia is a violation of their human rights.  The federal, provincial and territory governments of Canada were given a year – that is, until 6 February 2016 – to pass legislation consistent with this decision.

The required changes to Canada’s legal system and medical practice are massive and unprecedented.  The federal government has requested a six-month extension to ensure ‘a thoughtful, sensitive and well-informed response’ to the Supreme Court’s ruling, but has been given just four months to comply, that is, until 6 June.  If, and when, the necessary legislation is in place, Canada will have most advanced euthanasia laws in the world – more liberal and progressive than either the Netherlands or Belgium.  And Justin Trudeau’s landslide victory in October as Prime Minister-Designate will not help any of the causes dear to pro-life advocates.  The man has an appalling record on these issues, including calls for unlimited abortion up to birth.

Some Canadians have already jumped the gun.  By mid-January 2016, news came of the first case of legal voluntary euthanasia ever carried out by a doctor in North America.  A terminally-ill patient’s life was ended when a physician gave a lethal dose at a Quebec City hospital.  No further details about the case have been released.  And apparently two other such cases occurred during January in the Montreal area.

Assisted suicide in Germany
On 6 November 2015, the German Bundestag passed a law which permits assisted suicide for ‘altruistic’ but not for ‘business’ motives.  The voting was 360 vs. 233.  However, Germany has not legalised full-blown euthanasia.

The new law is similar to that of Switzerland, but the ‘altruistic’-‘business’ distinction is seen as an attempt not to replicate the setting up of commercial organisations like the Swiss suicide 'clinics', such as Dignitas.

It is anticipated that this new legislation will be appealed at the Constitutional Court by both anti-euthanasia campaigners and by German ‘assisted-suicide associations’.  It seems as though this German law is so badly drafted that it pleases no one.  Moreover, it appears to be riddled with dangerous loopholes.

Deep sedation in France
On 27 January, the French Parliament approved new end-of-life legislation creating a new ‘right’ for terminally-ill or gravely-ill patients to obtain ‘deep, continuous sedation altering consciousness until death’, on demand.  Both the National Assembly and the Senate voted for the same text.  Although this new, so-called Claeys-Leonetti law is said officially to stop short of euthanasia and assisted suicide, it is sufficiently ambiguous to be regarded as a perilous step towards euthanasia.  And because it is ‘on demand’, doctors will be under an obligation to deliver death – this is even more extreme than the current Dutch and Belgian end-of-life laws.

The Dutch euthanasia ‘peaceful pill’
The leading right-to-die organisation in Holland, the Dutch Association for a Voluntary End of Life (NVVE), is seeking talks with the Dutch Medical Association (KNMG) for approval of a ‘peaceful pill’, which would allow its members to kill themselves without the help of a doctor.

What a unnerving example this is of the bioethical slippery slope, denied by so many euthanasia proponents.  These very people are complaining to the media that such a pill is already being bought and used illegally, and on a vast scale.  Therefore what the Netherlands needs, they say, is legislation to regulate the pill’s supply and to guard against abuse.

NVVE director Robert Schurink has stated, ‘We see that society wants such a pill, particularly among the baby-boomer generation which is not afraid to speak its mind.  They want control over the end of their lives.’  Apparently the details of the proposed plan have yet to be worked out with the Ministry of Health, the Ministry of Security and Justice and the KNMG.

Incidentally, the 2014 figures show that there were 5,306 cases of euthanasia in the Netherlands.  The figure for 2013 was 4,829.

More care, less pathway
In 2013, the UK's Department of Health called for the abolition of the Liverpool Care Pathway (LCP).  This move had been prompted by an independent review, chaired by Baroness Julia Neuberger.  It showed that the LCP had often been misused and misinterpreted as a tick-box exercise.  The review recommended individualised care plans and better staff training in end-of-life care.  Care of dying people should be tailored to their individual needs and wishes, rather than being protocol driven.

In December 2015, the National Institute for Health and Care Excellence (NICE) published its updated guidelines entitled, ‘Care of Dying Adults in the Last Days of Life.'  NICE stated that its five recommendations are on:
    1]  recognising when people are entering the last few days of life
    2]  communicating and shared decision-making
    3]  clinically assisted hydration
    4]  medicines for managing pain, breathlessness, nausea and vomiting, anxiety, delirium, agitation, and noisy respiratory secretions
    5]  anticipatory prescribing.

On 16 December 2015, an article in the British Medical Journal summarised these NICE recommendations as imposing three new duties upon medical professionals, namely:
    1]  Seek support from more experienced staff, including those in palliative care services, if you are unclear about any aspect of care of the dying adult, including the recognition of dying and symptom management.
    2]  Assess for and treat any reversible causes of distressing symptoms or signs in people in the last few days of life – for example, uncontrolled pain or dehydration causing agitation.
    3]  Regularly review the care plan (usually daily), discuss any changes with the dying person and those important to the person; make clear documentation in the medical notes.

This all sounds eminently sensible.  However, whatever schemes, structures and systems are recommended, the quality of end-of-life care depends upon the dedication and intention of nurses, doctors and carers.  Every society may be judged by how it treats its most vulnerable citizens.  Proper, compassionate end-of-life care upholds the dignity of every life.  We hope that the dying will now receive even better support.

Access to Palliative Care Bill [HL] 2015-2016
On 2 February 2016, Baroness Finlay’s excellent private member’s Bill entered its Committee Stage in the House of Lords – this is a line-by-line examination of the Bill.  There is, as yet, no date set for its Report Stage.

Mr Philip Nitschke
In November 2015, the attention-seeking Australian euthanasia campaigner, Dr Philip Nitschke, burned his medical practising certificate, so ending his 25-year medical career.  However, now plain Mr Philip Nitschke has pledged to continue advising terminally-ill patients about how to commit their own suicides.

Nitschke has enjoyed years of confronting the authorities over the activities of his pro-euthanasia organisation, Exit, and over his worldwide lectures and demonstrations.  His comeuppance came after he allegedly counselled a 45-year-old man, Nigel Brayley, to take his own life.   An emergency meeting of the South Australian Medical Board of Australia in July 2014 suspended Nitschke’s medical registration.  He appealed.  In October 2015, the Board imposed 25 conditions for his return to practise.  Nitschke said these stipulations were too onerous and violated his free speech.  His many years of doctoring then went up in flames.

Death as a bureaucrat

On learning of his country’s Supreme Court’s decision to legalise euthanasia, the Canadian journalist, Joseph Brean wrote a perceptive and far-sighted article in the 4 December edition of The National Post.  The following is an extract:

‘But sooner or later, death will become a civil servant.  He will operate in the open, during business hours, with a budget and a boss.  His work will be humanized and bureaucratized.  Death will be licensed, regulated and empowered by law to solve a public policy problem – the unacceptability to certain people of certain types of dying.  This marks a major shift in the meaning of death, from ineffable human destiny to legislated human right.  This redefinition of death as a medical treatment is tricky.’

USA and Elsewhere
The Planned Parenthood saga
The Planned Parenthood Federation of America saga started in July 2015, when the Center for Medical Progress (CMP) released undercover films of its officials evidently offering to sell tissue samples from aborted foetuses.  The series of 11 videos went viral on YouTube, their authenticity was challenged, questions were asked on Capitol Hill, legal battles were started, truths and lies were traded – it became acrimonious.

Planned Parenthood was pushed onto the back foot.  For example, on 23 December 2015, the Obama Administration refused the numerous demands by politicians and others to investigate Planned Parenthood’s activities.  On 4 January 2016, Planned Parenthood revealed that it had performed 323,999 abortions and received $553.7 million from US taxpayers during the 2014-2015 fiscal year.  On 6 January, Congress voted in a bill, 240 vs. 181, to remove most of Planned Parenthood's federal funding.  On 8 January, President Obama vetoed that bill.  On 14 January, Planned Parenthood filed a lawsuit against the CMP accusing the group of violating numerous state and federal laws.  On 25 January, a Texas grand jury cleared Planned Parenthood of any wrongdoing and instead bizarrely indicted David Daleiden, the founder of CMP, and his associate, Sandra Merritt on two charges of tampering with government property and falsely offering to purchase human organs.  If found guilty, they face a maximum of 20 years' imprisonment.  This saga is far from over.

Arkansas, North Dakota and Ohio at the Supreme Court
In February 2013, the state of Arkansas passed its Human Heartbeat Protection Act and enacted it the following November.  This required an abortionist to perform an ultrasound before an abortion, and forbade abortion if a foetal heartbeat could be detected, effectively about 6 weeks into a pregnancy.  In March 2014, the Act was struck down by a federal judge because it, ‘... impermissibly infringes a woman's Fourteenth Amendment right to elect to terminate a pregnancy.’  After numerous legal challenges and counter-challenges, on 19 January 2016, the US Supreme Court ruled that it would not hear an appeal that could reinstate the Arkansas law.

At the end of January, news came that the US Supreme Court was also blocking North Dakota’s Heartbeat Bill, which would prohibit an abortion once a foetal heartbeat could be detected.  That move will probably also end a similar proposal from Ohio.

Texas at the Supreme Court
After several lower court decisions and appeals, the US Supreme Court decided, on 13 November 2015, to weigh-in on the wrangling over the Texas abortion regulation law.  It will be the first major abortion case to be heard since 2007, when the Court ruled in Gonzales vs. Carhart, upholding the constitutionality of the partial-birth abortion ban.  Already this upcoming event has been called ‘the abortion legal battle of the decade’.  The case will certainly have far-reaching and long-lasting consequences for millions of women’s health across several states with similar laws, including Pennsylvania, Michigan, Missouri and Virginia.

The Texas abortion regulations were passed by the Texas State Legislature in the summer of 2013 and signed into law by the then Governor, Rick Perry.  The law has two requirements.  First, all abortion clinics must comply with the basic health and safety standards set for an ambulatory surgical centre, including buildings, equipment and staffing.  Second, abortionists must have admitting privileges to a hospital within 30 miles in case any life-threatening complications arise.  Without such compliance, the health of mothers and their unborn children is judged to be at risk.  Abortion providers have countered by saying that the regulations are expensive, unnecessary and intended to put many of them out of business.  The regulations have already caused the closure of about half of the 41 Texan abortion clinics – 13 closed in one day.  There is considerable speculation that the Supreme Court will rule against the Texas law – but who knows?  No date has been set for the hearing, but a decision is expected in June.

Abortion declines in the USA

At the end of 2015, Operation Rescue, a leading US pro-life organisation, announced that the number of abortion clinics in the USA was continuing to decline.  This is a trend that began in 1991.  In 2015, 53 abortion clinics shut down or halted all abortion services.  Currently, there are 517 clinics offering surgical abortions and 213 offering medical abortions – these are the lowest numbers for decades.

Also recently, the US government agency, the Centers for Disease Control and Prevention announced that the number of abortions performed during 2012 dropped by 4%.  In total, about 699,000 abortions were reported to the federal government that year, which is 31,000 fewer than the year before.

The abortion rate has also declined.  In 2012, it fell by 5% to 13 abortions per 1,000 women of child-bearing age.  That is about half the rate of 1974, the year after the landmark Supreme Court decision that established a nationwide right to abortion in the case of Roe vs. Wade.

This is all further evidence that the US population is slowly turning against abortion.  In addition, a new Marist poll, published in January 2016, found that 81% of Americans would limit abortion to the first trimester of pregnancy.  This includes 66% of those who call themselves pro-choice.

The Supreme Court and Obamacare
Yes, this story is still rolling on, ever since the Affordable Care Act was passed in 2010
.  In November, the Supreme Court announced that it will decide cases brought by seven more complainants concerning whether the Obama Administration can force these employers to violate their religious beliefs and insist that they provide abortion-inducing drugs, sterilization, and post-fertilisation contraceptives to all their female employees.  In late March 2016, the Court will adjudicate for various Roman Catholic and Protestant plaintiffs, including the Little Sisters of the Poor, Priests for Life, East Texas Baptist University, Southern Nazarene University and Geneva College.

Poland defunds IVF
In late October of 2015, the Polish people elected a new government headed by the Law and Justice Party.  It has started to flex its conservative credentials by announcing that next year it will cancel government funding for the previous regime’s IVF programme – this move should save about £50m of taxpayers’ money over the following three years.

Poland has a very low birth rate.  The new health minister, Konstanty Radziwill, has told a parliamentary committee that the government wants to address the issue of procreation with a broader programme.

Poland and the United Nations
The United Nation’s Committee on the Rights of the Child published, on 30 October 2015, a 17-page document targeted at Poland.  The Committee was concerned that, ‘Official data and research on the prevalence of illegal and unsafe abortions is lacking.’  And that, ‘The strict legal requirements for abortion and the lack of a clear procedure for conducting legal abortions under current legislation, together with social stigma, hinder girls’ access to legal abortion.’  Furthermore, ‘… the Committee recommended that the State party: ‘… amend the 1993 Act on family planning, protection of the human foetus and conditions for legal abortion to make the conditions for abortion less restrictive and, in relation to adolescent girls.’  And ‘Establish clear standards for a uniform and non-restrictive interpretation of the conditions for legal abortion …’  I wonder what the new Polish government thinks about that!

US presidential election
On Tuesday 8 November this year, the people of the USA will go to the polls to elect a new president.  Abortion, and other bioethical issues, will play a part in campaigning and voting decisions.  At this stage of the circus, only a fool would attempt to predict the winner.  So I will refrain too, except to say that the new incumbent will be a man, or a woman.

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