Update on Life Issues - June 2017

Abortion - 50 Years of Shame
Fifty years ago on Friday 27 October, the 1967 Abortion Act received its royal assent and became law.  The killing started six months later on Saturday 27 April 1968.  This year, 2017, is therefore the 50th anniversary, the golden anniversary, the semi-centennial of the most cruel and perverse piece of legislation still on our Statute Book.  Under its precepts at least 8.6 million unborn lives have been snuffed out in England, Scotland and Wales.  How will you be marking this woeful event?  ‘Righteousness exalts a nation, but sin condemns any people’ (Proverbs 14:34).  An expanded essay, entitled Abortion - 50 Years of Shame, on this awful subject is included here.

Abortion and breast cancer

This is a most contentious topic.  Into the fray comes the latest research paper arguing that abortion is indeed a risk fact for breast cancer.  The work is entitled ‘The British Breast Cancer Epidemic: Trends, Patterns, Risk Factors, and Forecasting’ and is authored by Patrick S. Carroll, Jean S. Utshudiema and Julian Rodrigues.  It was published in the Journal of American Physicians and Surgeons (2017) 22: 8-15.

Can 70% of women be wrong?
Where Do They Stand? is a grass-roots, volunteer-led initiative which exists to help the UK public to learn the views of the general public and their elected representatives.  Recently it commissioned a ComRes poll to survey the public’s views prior to the General Election on a variety of issues.  In the poll of more than 2,000 people, it found that 70% of women (and 60% of the general population) wanted the abortion upper limit reduced from 24 to 20 weeks and 60% wanted the limit set at 16 weeks.  In addition, 90% of those questioned wanted sex-selective abortions banned.  The survey also found that 90% thought a woman considering an abortion should have a legal right to independent counselling from a source that has no financial interest in her decision.  Have you understood those messages, General Election candidates?

Abortions by midwives?
Here is good news and bad news.  The good news is that more and more young doctors are unwilling to perform abortions.  The bad news is that midwives might be given the task.  At least, this is the view expressed in an online paper by Sally Sheldon and Joanne Fletcher (Journal of Family Planning & Reproductive Health Care, 18 January 2017) and entitled ‘Vacuum aspiration for induced abortion could be safely and legally performed by nurses and midwives.’

The authors’ thesis is this: ‘Some 40% of abortions carried out in England and Wales are done by vacuum aspiration.  It is widely assumed that, in order to be lawful, these procedures must be performed by doctors.  However, a close reading of relevant law reveals that this assumption is unfounded.  On the contrary, it would be lawful for appropriately trained nurses or midwives, acting as part of a multidisciplinary team, to carry out vacuum aspiration procedures.  This interpretation of the law offers the potential for developing more streamlined, cost-effective abortion services, which would be both safe and highly acceptable to patients.’

First, some background.  Sally Sheldon, the lead author, is a Professor of law at the University of Kent.  For more than 20 years she has campaigned for abortion-on-demand and is currently a trustee of the British Pregnancy Advisory Service (Bpas), the largest provider of abortions in the UK.  Last year, she received a government grant of £512,000 for a research project called ‘The Abortion Act (1967): a Biography.’  This project was begun in May 2016 and its findings will be launched at the Houses of Parliament on 27 April 2018, the fiftieth anniversary of the Abortion Act coming into force.  In other words, Ms Sheldon is hardly an impartial observer.  This Sheldon and Fletcher paper’s conclusions are therefore no surprise, but they are still alarming.

They are alarming because they recommend shifting the responsibility for surgical abortions on to midwives and obstetric nurses.  The vast majority of these healthcare workers did not enter the profession to be involved in terminating the lives of unborn babies anything but.  Furthermore, if implemented, this shift would probably prompt a further erosion of freedom of conscience in the workplace and it would create another no-go area for Christians and the 'morally sensitive'.

Ellinor Grimmark
Ellinor Grimmark is a 40-year-old Swedish midwife and a Christian who refuses to carry out abortions.  She had originally been offered employment at Höglandssjukhuset women's clinic in Eksjö, southern Sweden, after completing an internship there in 2013.  She gratefully accepted the job offer, but reminded them that she could not perform abortions due to her strongly-held belief that life begins at conception.  That was the deal-breaker.  Her would-be boss, the head of the maternity ward, called and left her a voicemail saying that, ‘She was no longer welcome to work with them’ and questioning ‘whether a person with [pro-life] views actually can become a midwife.’

She filed a civil rights complaint against the Höglandssjukhuset clinic with the local Equality Ombudsman.  When, in November 2015, the Ombudsman ruled that Grimmark had not been discriminated against for her pro-life views, Grimmark escalated the complaint by filing a suit in the Jönköping district court with the help of a group called Scandinavian Human Rights Lawyers.  She was seeking 80,000 Swedish kronas (£7,200) in compensation for damages and 60,000 Swedish kronas (£5,400) in compensation for discrimination.  She has consistently argued that her Christian beliefs make it impossible for her to perform abortions and that it is also unfair for the authorities to turn her down for nursing jobs in the Jönköping region.

On 12 April 2017, a Swedish labour court of appeal defended the right of the Jönköping region to require its midwives to carry out abortions.  Moreover, the court maintained that she had not suffered discrimination, that the authorities had not violated her ‘freedom of opinion and expression’ and therefore it ruled against her.

The US Alliance Defending Freedom (ADF) is a partner with her legal team, the Scandinavian Human Rights Lawyers.  An ADF lawyer, Lorcan Price, explained, ‘What you have is a situation where an otherwise qualified midwife, able and willing to offer all the services a midwife traditionally offers in a hospital cannot be involved in abortion, as she sees it as the taking of human life.  Rather than attempting to accommodate her, to work around that one objection, or working in any positive way, she was simply sacked.  She was told flat out that until she agreed to be involved in the performing of abortions she would not be employed in any hospital in the Swedish health system.’

Ellinor Grimmark’s supporters say that the judgement against her contradicts international law protecting conscientious objection.  That, they say, is the whole point of the European Convention on Human Rights and the defence of conscientious objection is to allow people to object to things they think of as fundamentally wrong.  She now has a legal bill of about 1.5m kronas (£135,000).  Ms Grimmark is considering taking her case to a higher Swedish court, or even to the European Court of Human Rights.

Decriminalising abortion – in England and Wales
If you have read the previous item, you should not be surprised by this piece.  On 12 March, Diana Johnson (Labour MP for Hull North) tabled a Ten-Minute Rule Bill, entitled ‘Reproductive Health (Access to Terminations) Bill 2016-2017’, which called for the full decriminalisation of abortion across England and Wales.  This would mean all legal restrictions on abortion would be removed.  It was part of a campaign sponsored by Bpas, the Royal College of Midwives and others to rip up sections 58 and 59 of the 1861 Offences Against the Person Act, the 1967 Abortion Act and probably also the 1929 Infant Life (Preservation) Act.  Ten-minute rule bills signal an issue in Parliament, but they very rarely are given government time to allow them to be fully debated and become law.  The 1967 Abortion Act is a glaring exception to this pattern.

Opposition to this Bill was led by Maria Caulfield (Conservative MP for Lewes).  During her speech she stated, ‘I and many colleagues who share my views will not be silenced as we seek to be a voice for the voiceless … and as we argue for a more modern and humane abortion law that not only upholds the dignity and rights of women but the dignity and rights of the unborn child.  A 21st-century approach to this area must be based on a fuller and richer understanding of human dignity and equality which doesn’t treat women as a victim of her own body, which doesn’t treat children as commodities, and which doesn’t treat marginalised people such as young girls or children with Down’s Syndrome as burdens or inconveniences.  On this count this Bill fails.’

MPs were deeply divided on the issue and the Bill was narrowly passed by 172 to 142.  It was then read the First time.  The Second Reading was set for 24 March, but then delayed until 12 May.  In the meantime, a General Election was called, Parliament was dissolved and the Bill fell and no further action will be taken.  Hooray!

This vote was won by the pro-abortionists.  OK, the Bill fell, but only because of unusual circumstances.  OK, it was a Friday sitting and many MPs travel to their constituencies on that day so attendance was poor.  OK, ten-minute rule bills seldom make progress.  But this episode should serve as a wake-up call to MPs – there is real pressure at Westminster for a radical reform of abortion law, the sort that would remove all legal protection for the unborn.

Decriminalising abortion – in Australia
Decriminalisation is in the air, globally.  Australia’s Northern Territory Parliament decriminalised abortion on 21 March by a margin of 20 to 4.  The reforms have legalised the use of abortion drugs, such as RU-486, up to nine weeks into a pregnancy and repealed legislation that made it illegal to provide an abortion or supply a woman with abortion drugs.  Also now permitted are medical terminations in specialist clinics, instead of solely in city hospitals.  Previously, women in remote areas travelled hundreds of miles to access surgical abortions in urban hospitals.

Decriminalisation is indeed in the air, in the minds of some, in the plans of others, and already on the statute books of some jurisdictions.  The alarm bells are ringing – they are a call to action.  Have you heard them yet?

Assisted Reproductive Technologies

In vitro gametogenesis (IVG)

If IVF is bioethically problematic, IVG is gruelling.  Within the next 10 to 20 years, this new and controversial fertility technology, called in vitro gametogenesis, could make it possible to manipulate skin cells into creating a human baby.  Though the technology is difficult, the basic formula is simple, IVG = iPSC + IVF.  In other words, take a skin, or any other adult, cell, reprogramme it into an induced pluripotent stem cell (iPSC), convert that into a gamete, that is, a sperm and/or an ovum, use them in IVF to create a human embryo, transfer that into a woman, and deliver a baby.

IVG is not without its critics.  As Professor Eli Adashi of Brown University has declared, ‘There’s something troubling about an inexhaustible supply of gametes that can be fertilized into an inexhaustible supply of embryos.’  And, for example, it also raises the spectre of ‘embryo farming’ and ‘designer babies’.  It would turn procreation into a transaction.  It would introduce further fractures into parenthood, allowing more human combinations into the generation of a child.  It would allow singles, gays and lesbians to become parents.  It would genetically distance parents from child.  Contrariwise, it might allow one adult to be both father and mother – the ultimate in inbreeding.  And if gametes could be generated from easily-collectable skin cells, for example from a glass, people could be made parents without their knowledge or consent.  IVG has the potential to rewrite the biology of human reproduction.

So far, the first phase of IVG, that is production of ova, or oogenesis, has been successfully accomplished and tested by Japanese researchers on mice, which produced healthy babies derived from skin cells.  That work by Hikabe et al. was published in Nature (2016, 539: 299-303) as ‘Reconstitution in vitro of the entire cycle of the mouse female germ line.’  The second phase of IVG, in vitro spermatogenesis from iPSC, has been variously reported, but with methods that have proven difficult to replicate.  And besides biologically mice are not men.  Currently, it is not feasible – technically or legally – to create a human baby via IVG, but at least it is now plausible.


Another reason to shun IVF

A document recently published (28 February 2017) by the ethics committee of the American Society for Reproductive Medicine (ASRM), entitled, 'Unconventional combinations of prospective parents: ethical challenges faced by IVF providers', draws attention to the potential dangers of ‘intrafamilial reproductive arrangements.’  While so-called ‘collaborative reproduction’ typically involves anonymous or unrelated individuals, such as family friends, it is becoming increasingly common, at least in the USA, for first-degree relatives to share ova, sperm or wombs.


The document states that there are some combinations that should be rejected outright because they are consanguineous, such as the pairing of a sister’s ova with a brother’s sperm.  There are also ‘incestuous unions’, such as a father providing sperm for a daughter, who is using donated ova.  On the other hand, the committee is less opposed to arrangements such as a father giving sperm to his son’s wife.  Such ‘intrafamilial arrangements’ raise concerns not just about adverse genetic links but also about consent and family dynamics.

Human embryos as trinkets

An Australian company, Baby Bee Hummingbird, was launched in 2014 by midwife Amy McGlade.  It has pioneered a process to craft frozen human embryos into jewellery.  The items cost between £50 and £350, depending on the piece, and can be shipped worldwide.


Belinda and Shaun Stafford, are happy customers.  They used IVF to conceive a son and a twin boy and girl.  They did not know what to do with the seven frozen ‘spare’ embryos they had left over.  Belinda said, ‘Donating our embryos wasn’t an option for us and I couldn’t justify the yearly storage fee.  I’d heard others had planted them in the garden, but we move a lot, so I couldn’t do this.’  Instead, they opted to have the embryos made into jewellery – in this case, a heart-shaped pendant.  ‘My embryos were my babies – frozen in time.  When we completed our family, it wasn’t in my heart to destroy them.  Now they are forever with me in a beautiful keepsake.’


The company has faced a huge backlash on social media for making human embryos into commodities.  The answer is not to justify this business, but to stay away from IVF in the first place and avoid the problem of those inevitable supernumerary embryos.


The ova donation racket

In early May, The Daily Mail published a front-page story about the ethical and exploitative nature of ‘egg donation’.  The paper’s major allegation against the fertility industry, as visited by its undercover journalists, was that women are being persuaded to donate their healthy ova in return for free or discounted IVF treatments, specifcally at several clinics in London, Hertfordshire and County Durham.  The exposé has cajoled the HFEA into investigating the paper’s claims.  And Health Secretary, Jeremy Hunt, has said the allegations are ‘serious and worrying’.


Human ova are rare, but also at a financial premium.  They are needed for IVF and embryo research.  The voluntary donation of ova is regarded as an important safeguard which reduces the extent to which a woman’s body can be commodified.  Thus buying and selling of human ova is generally regarded as unethical.  The fertility pioneer, Lord Robert Winston, responded to the The Daily Mail's evidence of this practice as, 'I fear that some in my profession have no moral or ethical compass.  These women cannot appreciate the consequences of what they’re agreeing to.  These patients are vulnerable and anxious and likely to be worried about money.  The women who are egg sharing are under duress and that’s really worrying.’


There are considerable health risks to multiple ova production and donation.  It is invasive and often painful.  The inevitable process of superovulation can lead to ovarian hyperstimulation syndrome (OHSS), which is hazardous.  Follow-up of these women is random.  Psychological harm is not uncommon.  It is frequently disadvantaged and economically-needy women who are targeted.  For example, Newcastle University has advertised that ‘Donors will receive £500 compensation for a completed donation cycle.’  Is the health of women unimportant?  Does research and IVF trump their well-being?  Have fertility practitioners lost or fogotten their principles, morals and guidelines?  Who will protect these women?  Where are the regulators?


On 2 May, the HFEA issued the following statement, ‘We have clear rules in our code of practice, enforced by inspectors, that clinics must explain the risks and chance of success of treatment to each patient and donor, and avoid encouraging people to donate eggs and sperm with the promise of financial gain.  This investigation highlights potential breaches of our code and our inspectors will be investigating each allegation presented to us.  If we find that a clinic is in breach of our code, we will take regulatory action.’  Oh yes?  Come on paper tiger, show us some teeth.


‘Three-parent’ IVF – the details
In April, John Zhang and his team, who created the world’s first ‘three-parent’ IVF baby, published more details about the techniques used in the child’s conception (Zhang, J. et al. (2017) Reproductive BioMedicine Online 34: 361–368).  The essential procedure was already known.  It involved removing the nucleus from a healthy donor ovum and replacing it with a nucleus taken from the ovum of the woman who carried the neurological disease, Leigh syndrome.  This leaves the donor’s healthy mitochondria intact.  The scientists then performed IVF by fertilising the modified ovum with the father’s sperm before transferring it into the mother’s uterus.  The resulting baby boy was born in April 2016.

Zhang’s new paper reports the more detailed methods used to transfer the mitochondria and how they froze and heated the embryo before using an electrical pulse to fuse the mother's nucleus into the donor ovum.  It also reveals that some diseased DNA from the mother was carried over inadvertently into the donor ovum.

But the big questions remain – will the child's health be affected by the procedures and/or by the traces of the mother's diseased mitochondrial DNA that he carries, and will his mitochondria function properly?  The percentage of affected mitochondria varies among his tissues.  Just 2% of the mitochondrial DNA of cells in the boy’s urine came from the mother, but it was as high as 9% in cells from his circumcised foreskin.

But none of these key questions are likely to be answered because his parents have refused any further mitochondrial testing on the baby unless there is a medical need.  It is not clear whether the family was ever asked to consent to long-term medical monitoring.  There is now no way to assess the long-term health of this uniquely-conceived child and determine if ‘three-parent’ IVF is indeed safe.  What are the risks of this experimental technique of mitochondrial replacement therapy?  What is in the best interests of the boy?  This is medical science at its worst.  This is all most unsatisfactory.

'Three-parent' IVF the approval
On 16 March, the HFEA published the following statement.  Sally Cheshire, its chairwoman, said, ‘I can confirm today that the HFEA has approved the first application by Newcastle Fertility at Life for the use of mitochondrial donation to treat patients.  This significant decision represents the culmination of many years hard work by researchers, clinical experts, and regulators, who collectively paved the way for Parliament to change the law in 2015 to permit the use of such techniques.  Patients will now be able to apply individually to the HFEA to undergo mitochondrial donation treatment at Newcastle, which will be life-changing for them, as they seek to avoid passing on serious genetic diseases to future generations.’

On the basis of the work of Zhang and his colleagues, as reported above, there are more questions than answers concerning ‘three-parent’ IVF, or mitochondrial donation.  Has the HFEA, again in its usual overenthusiasm to be at the forefront of world-beating research, jumped the gun?

New embryo experimentation guidelines

There is pressure building to extend the 1990 Human Fertilisation and Embryology Act's 14-day rule for embryo experimentation.  Now new regulations are being proposed based on a quite different concept.  They were published on 21 March 2017 in eLife under the title of ‘Addressing the ethical issues raised by synthetic human entities with embryo-like features’ by Aarh, J. et al. from the Department of Genetics, Harvard Medical School.

The 14-day rule, based on the appearance of the primitive streak, was always a daft and arbitrary cut-off point.  Now, because scientists have the ability to culture human embryos beyond 14 days and because they can create ‘synthetic' structures, such as organoids or embryos assembled from stem cells in the laboratory, new rules are required, we are told.  These biological structures, referred to in the eLife paper as 'synthetic human entities with embryo-like features' (SHEEFs), are becoming increasingly sophisticated, and even more complex examples could soon be constructed, such as, a rudimentary brain connected to a beating heart.

Limits, such as the current 14-day rule, are based on 'stop signs', or the appearance of certain features.  These, Aarh and colleagues argue, are unsuitable for SHEEF research.  This is because SHEEFs do not necessarily follow the same developmental processes as ‘normal’ embryos and would not necessarily hit such ‘stop sign’ limits before developing attributes that are of bioethical concern.  Instead of ‘stop signs’ they propose ‘perimeter fences’, where there is an agreement that there is an area of concern.  For example, it might be agreed that we cannot make a brain that will allow it to feel pain, or we cannot make something like a heart, but we can make up to it … as long as it doesn't start beating.’

This is all scientific hocus-pocus.  How could there ever be universal agreement on such issues?  What would be the objective, as opposed to the subjective, criterion for instance with the heartbeat scenario?  For a start, what is so special about a beating heart?  Is not that merely an emotive ‘perimeter fence’?  And, when does it start beating?  Day 21 or day 22 of 'normal' development?  This is sentimental, arbitrary claptrap.  It is no better than the 14-day rule.  It would be a replacement scheme that is just as broken as the original.

Who can doubt that the 14-day rule will be extended?  As Melanie McDonagh, writing in The Spectator (4 March 2017), put it, ‘In Britain you can pretty well get away with anything if you say it’s to help sick kiddies or help infertile couples become pregnant.  At what point you say that experimenting on early human lives for the benefit of others is anyone’s guess.  In pragmatic, post-Protestant Britain, the end justifies the means.'

IVF a profitable business
ccording to an industrial analysis company, Research and Markets, the world market for IVF and IVF products will grow from US$8.4 billion this year to $12.5 billion by 2022.   Research and Markets says that, ‘Factors driving growth in the market are increasing number of cases of infertility owing to lifestyle changes involving unhealthy nutritional habits, penetration of advanced procedures in developing nations, and favorable government initiatives.  Geographically, Asia-Pacific is expected to witness the highest growth owing to rising aging population in Japan, favorable childbearing policies in China and rising awareness in countries like India, South Korea, and Thailand.'

Demand for IVF is growing at about 10% annually, owing to raising awareness and social acceptability.  Infertility is no longer just a Western problem, with about 25% of couples in developing countries affected by it, according to the World Health Organisation.


I've always maintained that the two greatest drivers of almost every corrupt human enterprise are sex and money – see what I mean?


Gene editing
Editing human embryos – the latest

In April 2015, it was reported that researchers in China, led by Junjiu Huang at the Sun Yat-sen University in Guangzhou, used the gene-editing tool CRISPR-Cas9 to edit the rogue gene responsible for the disease β-thalassaemia out of human embryos.  The embryos were non-viable because they carried extra chromosomes.  These world-first results were published in the online journal Protein & Cell under the title, ‘CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes.’  The world-second report of editing human embryos appeared in the April 2016 edition of the Journal of Assisted Reproduction and Genetics by Yong Fan and colleagues from the Guangzhou Medical University.  Their paper was entitled, ‘Introducing precise genetic modifications into human 3PN embryos by CRISPR/Cas-mediated genome editing.’  They introduced a mutated gene, known as CCR5Δ32, into some of the embryos, which can confer resistance to HIV.  Again, the embryos they used, ‘spares’ from IVF, were reported to be abnormal and unsuitable for implantation because they also contained an extra set of chromosomes – they were destroyed three days after the experiment began.


So the next tantalising challenge was to try gene editing using viable human embryos.  In June 2017, a report in Molecular Genetics and Genomics, entitled ‘CRISPR/Cas9-mediated gene editing in human zygotes using Cas9 protein’ by Tang et al. showed, for the first time that mutations in normal human embryos could indeed be corrected.  The team, led by Jianqiao Liu at the Third Affiliated Hospital of Guangzhou Medical University, used ova leftover from IVF procedures and fertilised them with donor sperm from two men who suffered from diseases that are common in China.  Six embryos were created.  One of the sperm donors had a mutation called β41-42, which causes β-thalassemia, while the other donor had a mutation in the G6PD gene, which is a cause of favism, a disorder which results in the spontaneous destruction of red blood cells after eating, for example, broad beans.


Four of the resulting embryos had the β41-42 mutation, while two had mutations in the G6PD gene.  They were subjected to the CRISPR-Cas technique and allowed to develop for two days.  Then their DNA was analysed to establish if the mutations had been successfully corrected.  The β41-42 mutation was only partially corrected in one embryo, forming a mosaic embryo.  CRISPR-Cas induced an additional mutation in another embryo, and the technique did not work at all in the two remaining embryos.  The mutation in the G6PD gene was successfully repaired in one embryo.  In the other embryo, it was corrected only in some cells, thus also forming a mosaic embryo, that is, with a mixture of edited and unedited cells, a combination of both repaired and unrepaired cells.


This work has been described as ‘promising’ and ‘encouraging’ yet it pointed out serious limitations and complications.  The trial was small, the methodology not entirely efficient and it included the continuing worry of ‘off-target’ mutations.  The occurrence of mosaicism also needs solving – perhaps by editing ova and sperm, rather than embryos.  And, of course, there are all those underlying grave bioethical concerns about genetically editing humans.  In fact, this type of germline editing probably will not be the first way CRISPR-Cas9 is used to tackle human genetic diseases.  Researchers are already planning experiments to edit genes in the somatic cells of patients.  Such experiments come with fewer bioethical questions, but also many remaining technical hurdles.  And anyway, almost all inherited diseases can already be prevented for most couples by existing forms of screening, such as preimplantation genetic diagnosis (PGD) of IVF embryos, without any need for CRISPR.


CRISPR, drugs and tumours

Tumours can often become resistant to individual drugs, but it is well known that certain drug combinations can be surprisingly effective in destroying such drug-resistant tumours.  Michael Bassik and his colleagues at Stanford University have developed a method based on CRISPR–Cas9 that can offer a way to discover such useful mixtures.  The work was reported in Nature (23 March 2017, 543: 467) under the title, ‘CRISPR finds drug synergy.’


Their method systematically disables two genes at a time in cells.  They used their system to knock out 21,321 pairs of potential drug targets in leukaemia cells, looking for combinations that work synergistically to kill cancer cells.  They found that disabling two genes, called BCL2L1 and MCL1, destroyed drug-resistant cells.  Drugs that inhibited these genes killed more leukaemia cells than each of the two medicines did when used individually.  It looks like a step forward in cancer treatment.


Who owns CRISPR?

Where would biology be without an input from lawyers?  For ages, a hotly-contested battle has been raging between the Broad Institute of MIT and the University of California over who owns the intellectual-property rights to CRISPR, the potentially lucrative technology.  Although the Broad Institute was awarded its patents first, the University of California was the first to apply for a patent on the technology.  The Californian scientists also argue that its team in Berkeley invented the technique before investigators at the Broad.


In December 2016, the US Patent and Trademark Office (USPTO) upheld a series of patents granted to the Broad Institute.  Then lawyers representing the University of California filed for an ‘interference proceeding’ in order to have the Broad’s patents rejected.  But on 15 February 2017, patent judges determined that there was no interference, meaning that the Broad Institute’s patents will stand.  The University of California’s patent application will now be referred back to an examiner, but legal challenges will probably continue – of course!  Biology and law – what a potent cauldron of contrary disciplines.

Stem-Cell Technologies

The Human Induced Pluripotent Stem Cell Initiative (HipSci)

In May 2017, the Wellcome Trust and the Medical Research Council (MRC) announced a £12.75 million initiative to create a catalogue of high-quality adult stem cells, the so-called induced pluripotent stem (iPS) cells.  This initiative known as HipSci is the UK’s largest resource of human stem cells and has been heralded as a powerful research tool for studying human development and diseases including cancer, Alzheimer’s and heart disease.

The strategy is to lay the foundations to create a new iPS cell bank, providing a world-class resource for UK researchers.  So far, 711 cell lines have been created and detailed information about their genomes, the proteins they express and their cell biology has been generated.  This knowledge base is openly available to the research community.

It is significant that this Initiative deals exclusively with iPS cells, produced by that Nobel Prize-winning technology, which is bioethically uncontroversial, and not the once-celebrated embryonic stem cells, which are bioethically objectionable.

The Californian experience
In 2004, Californian voters approved $3 billion funding for stem-cell research.  Biologists flocked to the Golden State and citizens dreamed of cures for Parkinson’s disease, spinal-cord injuries and so on. Now, that pot of money is running dry and treatments have yet to emerge.  Will Californians pour billions more into stem-cell research controlled by the California Institute for Regenerative Medicine (CIRM)?  If not, hundreds of scientists could be without jobs and potentially promising therapies could be abandoned before they reach the clinic.

Already CIRM has had its fingers badly burned – it initially invested heavily in embryonic stem-cell research that got virtually nowhere.  It then, too late, switched to adult stem and iPS cell research.  Now the CIRM is doling out its final $650 million while its leaders are seeking money from the private sector to carry projects beyond 2020, when the money will finally run out.

Induced pluripotent stem (iPS) cells and transplant organs
There are never enough transplant organs to meet demand.  Could stem cells be used to create additional organs?  In 2010, a team led by University of Tokyo Professor Hiromitsu Nakauchi devised a new technique for creating such organs using iPS cells.  The team injected a rat iPS cell into an embryo grown from a mouse’s fertilised egg, which was then put back into the mouse’s womb, which resulted in a functional rat pancreas in a newborn mouse.  Could such technology create human organs inside the bodies of animals, such as pigs?

In January 2017, scientists at the Salk Institute for Biological Studies in the US announced that they had inserted human iPS cells into pig embryos and successfully created pig foetuses containing human cells.  The Institute said this achievement marked, ‘the first step toward the generation of transplantable human organs using large animals.’  The work was reported in Cell (168: 473-486) under the title, ‘Interspecies Chimerism with Mammalian Pluripotent Stem Cells.’

In the same month, the University of Tokyo team announced that it had created a pancreas derived from a mouse in a rat’s body.  The implanted mouse remained in good health for a long period of time, with minimal doses of immune suppressor drugs required.  Nakauchi stated, ‘We proved our method to be effective and safe.  We’re planning to start producing human organs within five years, and hope to deliver them to patients.’  However, for ethical reasons putting an embryo containing human cells into an animal womb is prohibited in Japan.  Nakauchi is therefore planning to move his base to a US laboratory to create human-sheep chimeras.

Meanwhile, the US scientists at the Salk aim to develop a new technology that would serve as an ‘organ factory’.  But the success rates for creating human-pig chimeras are very low.  The team used more than 40 staff members to insert 1,466 chimeric embryos into pig wombs over a four-year period.  Yet only 67 of the resultant pig foetuses contained human cells, and the ratio of human cells to pig cells was low – one cell or less per 100,000.

‘Artificial embryos’ from stem cells
Scientists at the University of Cambridge have used two types of stem cells from mice and a 3-D scaffold to create ‘artificial embryos’, structures that closely resemble natural mouse embryos.  Previous work had limited success, but this is believed to be a world first, with the hope of improving fertility treatments (of course) as well as insights into early embryo development (of course).

This work, published in the journal Science (2 March 2017) as ‘Assembly of embryonic and extra-embryonic stem cells to mimic embryogenesis in vitro’, used embryonic-stem cells plus a second type of stem cell, known as extra-embryonic trophoblast stem cells, which form the placenta.  Lead researcher, Magdalena Zernicka Goetz said, ‘We knew that interactions between the different types of stem cells are important for development, but the striking thing that our new work illustrates is that this is a real partnership – these cells truly guide each other.’  Christians will recall Psalm 139: 14, ‘I praise you because I am fearfully and wonderfully made.’  However, an artificial embryo is unlikely to develop into a healthy foetus as it would probably need the third form of stem cell, which develops into the yolk sac that provides nutrition.  And, of course, if such experimental human embryos were created, they would not be allowed to develop beyond 14 days.  So, it is obvious that bioethical predicaments are stacking up against this technique.

Blood from stem cells
Could this be the end of the road for all those altruistic blood donors?  Over the last twenty or so years scientists have longed to produce ‘artificial blood’.  Now that goal is apparently within grasp.  The breakthrough has centred on a special sort of stem cell known as the haematopoietic stem cell (HSC).  From this type of cell all the basic components of blood are generated.  And a group, led by George Daley at Harvard University, has seemingly overcome the final technical hurdles.  They first took ordinary human adult cells, added a mixture of seven transcription factors which reprogrammed them into induced pluripotent stem cells (iPSC) and then coaxed these into HSCs.  The end-product, when injected into mice, produced the complete set of human blood cells – well, almost, though not exactly identical to those found in nature, they were tantalisingly close.

The outlook could be staggeringly good.  For instance, take cells from patients with genetic blood disorders including leukaemia, use CRISPR to correct the genetic defect and then make functional blood cells so that patients could receive laboratory-grown versions of their own healthy cells.  Also, use cells from universal donors and make limitless supplies of donative blood for everyone.  We are not there yet – human clinical trials are needed and safety concerns must be allayed, but it certainly does look promising.  This work was reported in Nature (online 17 May 2017) under the title, ‘Haematopoietic stem and progenitor cells from human pluripotent stem cells.’

Oesophagi from stem cells
Doctors at Great Ormond Street Hospital (GOSH) are set to become the first in the world to modify pig organs to treat newborn babies with birth defects.  Next year, about 10 babies born with a section of their oesophagi missing, a condition known as oesophageal atresia, are to receive transplants harvested from pigs and then modified using the child’s stem cells.  The condition can be diagnosed in the foetus at around 20 weeks.  Oesophagi of varying sizes have already been taken from pigs at a British farm in readiness.  These ‘animal scaffolds’ will have all their porcine cells removed and then for the next 8 weeks will be reengineered with the born child’s stem cells taken soon after birth from the baby’s muscle and residual oesophagus.  About 2 to 3 months after birth, the ‘new’ oesophagus will be transplanted.

The man behind this novel treatment is Professor Paolo De Coppi, a consultant paediatric surgeon at GOSH.  In 2010, he pioneered a similarly ground-breaking transplant in which a 13-year-old boy was given a new trachea, which had been created from a deceased human donor plus the teenager’s stem cells.

Age-related macular degeneration (AMD) and iPS cells
In 2014, Masayo Takahashi and Yasuo Kurimoto from the RIKEN Center for Developmental Biology in Kobe took retinal cells derived from induced pluripotent stem (iPS) cells and successfully transplanted them into a woman suffering from age-related macular degeneration (AMD).  This was the world’s first surgical procedure using iPS cells. 

On 28 March 2017, the same Japanese scientists undertook a similar procedure, but with an important twist.  This time, a Japanese man in his 60s became the first person to receive a retinal repair with cells derived from iPS cells donated by an anonymous donor.   Skin cells from the donor were reprogrammed into iPS cells and then turned into a type of retinal cell, which was in turn transplanted onto the retina of the AMD patient.  The success of the surgery will have to wait while the fate and function of the introduced cells are monitored.  The work was reported in The New England Journal of Medicine (2017, 376: 1038-1046) as ‘Autologous Induced Stem-Cell-Derived Retinal Cells for Macular Degeneration.’

And when it all goes wrong
It has been reported (The New England Journal of Medicine 2017, 376: 1047-1053) that three patients have developed vision loss in both eyes after undergoing stem-cell injections for age-related macular degeneration (AMD) at a US clinic.  The authors have called for stricter management of both the procedures using stem cells and the clinics providing these treatments.  They highlighted the need to increase public awareness of the ‘possibility of devastating outcomes’ with such unregulated treatments.  In this case, adipose tissue-derived ‘stem cells’ had been used and all three patients experienced severe visual loss after one year.  This is beyond sad.  Beware, not all stem-cell ‘treatments’ are panaceas.  Stem-cell charlatans are out there.

Euthanasia and Assisted Suicide

Noel Conway – the latest
Noel Conway is the 67-year-old retired college lecturer, who has motor neurone disease (MND), and is not expected to live for more than 12 months.  Mr Conway wants the right to die.  He wants a declaration that the 1961 Suicide Act is incompatible with Article 8 of the 1998 Human Rights Act, which relates to respect for private and family life, and Article 14, which protects from discrimination.

On Thursday 30 March 2017, a decision was handed down on the Noel Conway v. Ministry of Justice case denying permission for it to proceed.  Noel Conway’s legal team appealed this decision and a hearing took place on Tuesday 11 April 2017.  This appeal was successful and the earlier decision was overturned.  Noel’s case will now proceed to a full hearing in the High Court.

Back in 2014, the case of Tony Nicklinson, who suffered from paralysis after a stroke, was ultimately dismissed by the Supreme Court.  Noel Conway’s case is considered by Dignity in Dying, his backers, to be different from the Nicklinson challenge in that Noel has a terminal illness and his legal team are setting out strict criteria and clear potential safeguards to protect vulnerable people from any abuse of the system.  These include:
            that the adult is suffering a terminal illness diagnosed with six months or less to live;
            medical evidence confirming the individual has mental capacity to make the decision;
            evidence of the person’s wishes and that they were informed, clear, settled and voluntary;
            medical professionals involved would report the assistance given to an appropriate person or organisation;
            a High Court judge could be asked to confirm these criteria have been met.

The Not Dead Yet UK organisation is a network of disabled people in the UK who oppose the legalised killing of disabled people.  It has issued a statement on the Conway case.  It reads, ‘While we empathise with Mr Conway in his legal attempt to avoid what he wrongly believes is inevitable suffering at the time of his death we strongly maintain that changing the law to allow physician Assisted Suicide will endanger the lives of the UK’s many ill and disabled people who, with the right amount of appropriate care and support can and do achieve a peaceful passing.  More importantly, this type of support allows disabled and ill people to live full and enjoyable lives, with no fear of unnecessary death from coercion, error or human prejudice holding them back.’

There is also the associated case of Omid (whose surname cannot be released).  He was diagnosed in 2014 with the non-terminal neurological condition, multiple system atrophy.  Omid does not have a terminal diagnosis and is calling for assisted suicide to be made available to anyone who is suffering unbearably, not just those who are dying.  Omid asked for permission to intervene in Noel’s case in March but permission to bring a case was not granted to Noel at the time of that hearing.  In order for Omid’s case to progress it will need a separate permissions hearing.

Euthanasia in Québec
The report on the first full year (2016), since Qu
ébec legalised euthanasia has been published.  It is alarming – compared with the first six months of 2016, the rate during the last half of the year had almost doubled.  According to the Protection of Conscience Project report, ‘If Québec's rate continues without escalation throughout 2017, it will exceed that achieved by Belgium after nine years.’

There were 256 requests for euthanasia in Québec during the first six months of 2016 and 441 in the second half.  There were 163 patients actually euthanized in the first six months and 286 in the second.  Québec’s total of 449 euthanasia deaths comprised 0.7% of all its deaths in 2016.  In Belgium’s first year (2003), euthanasia accounted for only 0.2% of all deaths.  An additional statistical measure shows the same pattern.  In Québec's first year, 5.4 people per 100,000 died by euthanasia, while in Belgium’s first year 2.5 people per 100,000 were euthanized.  These figures are bad, but not as bad as those from the Netherlands – it started in 2002 with a rate of 11.7 persons euthanized per 100,000 but has now reached 32 per 100,000.

Euthanasia numbers in Canada and Holland
CBC News has reported that 1,324 medically-assisted deaths occurred in Canada during the 10 months since legalisation on 17 June 2016.  The actual number is likely to be higher, as some provinces, notably Québec, British Columbia and New Brunswick, were unable to provide up-to-date information, though Québec jumped the gun with legalisation beginning on 10 December 2015.

The Netherlands recently reported that there were 6,091 assisted suicides in 2016, representing a 10% increase on the previous year and 4% of all deaths.  Based on the current number of assisted deaths, it is possible that Canada will surpass both the Netherlands and Belgium.

Assisted suicide in Washington DC
In mid-February, Washington, DC became the seventh jurisdiction in the US to legalise assisted suicide, as the Republican-controlled Congress failed to block the law.  The other members of the infamous US septet are California, Colorado, Oregon, Vermont, Washington state and Montana.

The Home Rule Act of 1973 gives Congress power, under the aegis of the Oversight Committee, to overturn DC laws within a certain time frame after their passage.  On 13 February, the Oversight Committee voted 22 to 14 to cancel the District of Columbia’s new assisted suicide law, the Death with Dignity Act.  The next step in cancelling it would have been to bring the resolution to a full House vote.  Because of political bungling, the full House never had the opportunity to vote and so assisted suicide became legal.  A wonderful opportunity to block assisted-suicide legislation was missed.  Congress messed up, big time!

Just what is happening in Montana?
The status of assisted suicide in Montana is curiously unsettled.  In 2009, the Montana Supreme Court decided that, ‘a terminally-ill patient’s consent to physician-assisted aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician.’  In other words, there is nothing in Montana's state’s law that prohibits a doctor from helping a patient to commit suicide.  This effectively permitted assisted suicide – without input from the Montana legislature.

For almost the last two decades, opponents and supporters of assisted suicide have regularly tried to introduce bills to settle the matter, that is, either to regulate or to ban assisted suicide.  So far, none of them has succeeded.  The latest banning bill, House Bill 365, almost succeeded, but then failed at the very last minute.  The Bill, which declared that a patient’s consent would not be a defense for an assisting doctor, passed a second reading on a 52 to 48 vote during 28 February.  But at the third reading on the next day, 1 March, the Bill was defeated.

So what happened?  It was a classic case of legislative comedy.  On 1 March, two lawmakers changed their vote to support assisted suicide, making that day’s vote 50 to 50.  Then one decided not to support the Bill, making it 51 for and 49 against.  Meanwhile another member of the House, Peggy Webb, a Republican who opposes assisted suicide, made a blunder and voted for the Bill, making the outcome 50 to 50.  ‘It was a mistake,’ said Ms Webb, but it was too late to change it back.’  The sponsor of the Bill, Brad Tschida, was philosophical about his colleague’s error.  ‘No snowflake in an avalanche feels guilty’, he said.  ‘Human beings are emotional creatures more than they are rational.’

The traffic is not all one way
The world, including the USA, has not gone assisted-suicide mad.  Despite that impression from the media, several anti-life bills have been recently defeated in Indiana, Mississippi, Tennessee and New Mexico.  For example, in New Mexico, the state Senate voted 22 to 20 against a bill to legalise assisted suicide for people expected to die within six months.  Similar bills have stalled in Hawaii, Maryland, Utah and Wyoming.

For instance, in sunny Hawaii, a House of Representatives committee unanimously decided recently not to advance a proposed Medical Aid in Dying Act allowing physicians to prescribe lethal drugs on the same day a patient is diagnosed as terminally ill.  Furthermore, the Hawaii legislature passed not one of the five assisted-suicide bills proposed during its 2016 session – all failed by the May 4 deadline adjournment.

Meanwhile, Maine has also bucked the apparent trend and defeated an assisted-suicide bill.  On 18 May, the Maine State Senate narrowly passed a measure called An Act to Support Death with Dignity by 16 to 15.  But on 23 May, the Maine House of Representatives voted 85 to 61 against it.  This was the eighth attempt in recent years by Maine activists to change a lethal dose of drugs into a ‘medical treatment’.

Also, at the end of May, the Tasmanian Parliament rejected the latest attempt to legalise euthanasia in the Australian state.  Although the media forecast that the vote would be close, The Voluntary Assisted Dying Bill 2016 was defeated in the lower house by 16-8.  This was the third try in 10 years to pass a euthanasia bill.  As one opponent of the Bill declared, ‘No one can say that the Tasmanian Parliament has not taken this issue seriously.  This is a resounding affirmation that Tasmanian society takes a dim view of doctors helping people to suicide.  Other Australian states should take note.’

Doing right and defending the vulnerable is a complex, but necessary, business.  It can be time-consuming and demoralising, but the alternative, to do nothing, is reprehensible.  We have been told over many years that assisted suicide is unstoppable, an idea for which the time has come.  What nonsense!  Universal legalisation is anything but ‘inevitable’.  Onward!

USA and Elsewhere

What has Donald Trump done?
This is not the place to provide a comprehensive assessment of President Trump’s first few months in the White House.  Suffice to say he has made some sweeping, and positive, policy changes in terms of bioethical issues.  For example, as recently as 15 May, he expanded the Mexico City Policy, which bans federal funding for abortions outside US borders.  And his so-called Protecting Life in Global Health Assistance policy also blocks US funding of foreign aid to non-governmental organisations that provide or promote abortion or mention abortion in connection with family planning.  The policy applies to approximately $8.8 billion of aid.

Furthermore, he has raised the profile of this year’s annual National March for Life.  He has signed an executive order entitled ‘Promoting Free Speech and Religious Liberty’.  He has chosen the evidently pro-life Neil Gorsuch for the key role of a US Supreme Court Justice and has also made other strong pro-life appointments including the choice of his vice-president, Mike Pence; Attorney General, Jeff Sessions; Health and Human Services Secretary, Tom Price, and Counselor to the President, Kellyanne Conway.  Most recently the pro-life activist Charmaine Yoest has been given the job of Assistant Secretary of Public Affairs at the Department of Health and Human Services (HHS).  Yoest is the former CEO of Americans United for Life and regarded as the ‘legal architect of the pro-life movement’.  The man Yoest is replacing is now a vice-president of Planned Parenthood.  And Trump has recently hired another top social conservative, Shannon Royce, former chief of staff at the pro-life lobbying organisation, the Family Research Council, to work in the HHS as the Director of the Center for Faith-based and Neighborhood Partnerships.  And so the impressive recruiting list goes on.

And to top it all, Planned Parenthood, the largest abortion provider in the US, is about to be defunded to the tune of an annual $450 million.  At least, President Trump's 2018 budget proposal would withhold all federal funds from Planned Parenthood, if, and it may be a big ‘if’, the new Republican healthcare legislation, the so-called American Health Care Act (AHCA), which was narrowly approved by the House of Representatives (217 to 213) in early May, also passes the Senate and is signed into law.  It would mean that Trump has kept his pro-life promises, including stopping US taxpayers from being forced to fund abortion and abortion businesses.  Of course, there have been disappointments, but there is no denying that the President is packing his administration with pro-life, pro-family advocates.

Abortion and climate change
You have probably never linked these two topics.  Well, that old US radical feminist icon from the 1960, Gloria Steinem, has.  She, who has long campaigned for unrestricted, government-funded abortion and she, who popularised the ‘I got an abortion’ t-shirt, has found a new string to her bow. She is now blaming ‘man-made’ climate change on too few women aborting their children.

In a 9 May interview with Refinery29, the American-based fashion, style, and beauty website, she said, ‘What causes climate deprivation is population.’  And, ‘If we had not been systematically forcing women to have children they don’t want or can’t care for over the 500 years of patriarchy, we wouldn’t have the climate problems that we have.  That’s the fundamental cause of climate change.’  And, ‘The world’s main salvation from polar ice-cap melt is more abortions.’  The 83-year-old former Playboy bunny is now officially batty.

Abortion law in Iowa and other US states
On 18 April, the Iowa legislature passed a bill banning most abortions after 20 weeks with no exceptions for rape, incest or foetal anomalies, though it does permit abortions in cases when a mother’s life or health is at risk.  The state Senate voted 30 to 20 to approve the so-called Senate File 471 after heated debate.  The law would include a 72-hour waiting period prior to abortion.  On 5 May, the bill was signed into law by Governor Terry Branstad.

This legislation makes Iowa the sixth US state to have a three-day ‘cooling-off’ wait before an abortion.  Sixteen other states have banned abortion after 20 weeks, namely, Alabama, Arkansas, Georgia, Idaho, Kansas, Kentucky, Louisiana, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, West Virginia and Wisconsin.  When those two great seaboard states of California and New York are included in this list we will know that serious pro-life legislation is being enacted in the USA.

Abortion in New South Wales
In May, the Upper House of the New South Wales parliament was brought to a shocked silence as one of the largest official parliamentary petitions in its history was tabled by the Hon. Greg Donnelly.  The petition contained 56,559 signatures.  Members looked away from their phones and paid attention as two of Donnelly’s staff members brought in large document boxes containing the petition sheets.  An audible gasp filled the chamber.

The petition opposed the Abortion Law Reform (Miscellaneous Acts Amendment) Bill 2016.  That Bill aimed to decriminalise abortion, specifically to ‘… amend certain Acts to repeal offences relating to abortion, to specify a ground of unsatisfactory professional conduct by a medical practitioner with respect to abortion and to establish exclusion zones in order to prohibit certain behaviour near premises at which abortions are provided.’  This opposing petition contained the signatures of residents from Sydney and throughout regional areas of New South Wales.  The petition coordinator, Rebecca Gosper from Youth for Life, said, ‘We were really hoping to get 10,000.’  She simply recruited a few friends, created a page on Facebook for the campaign, and off it took.

The author of the Bill, Mehreen Faruqi‏, was not present when the pro-life petition was tabled.  She has her own official petition in favour of the Bill, running since November 2015, which is yet to be presented to the Parliament.  An unofficial supporting online petition contained just 2,028 signatures.  On Thursday 11 May, the Bill was roundly defeated Ayes 14 and Noes 25.

Bad news for France
On Sunday 14 May, the 39-year-old Emmanuel Macron took over as France’s new president.  His predecessor, François Hollande, was a pro-life, pro-family disaster.  He extended abortion rights, legalised gay ‘marriage’, permitted terminal sedation, and so on.  Will Macron be any better?  Probably not.  His electoral platform certainly did not propose a single pro-life or pro-family measure.

It seems as though the traditional French secular state with its entrenched Enlightenment philosophy is set to continue.  Perhaps the most that its minority of pro-life citizens can hope for is a preservation of the status quo and an avoidance of any further sliding into the culture of death.

Ireland and abortion
Over a weekend in late April, The Citizens' Assembly voted on a series of questions about the Eighth Amendment of the Irish Constitution.  This protects the equal right to life of the mother and unborn child.  The Assembly, which consisted of 99 people randomly selected by a polling company and chaired by a Supreme Court judge, Ms. Justice Mary Laffoy, recommended that Ireland approve the legalisation of abortion.

Almost two-thirds (64%) of the Assembly voted for decriminalisation of abortion, with almost half (48%) recommending an unrestricted right to abortion in the first three months of pregnancy, and 44% saying this should be extended to 22 weeks.  Some (8%) thought there should be no restrictions on gestational age.

The results of these votes will be submitted to the Dáil sometime in June and will initially be considered by a 20-member Oireachtas Committee which will decide whether legislative changes should be put to the two houses of the Irish Parliament, the Oireachtas, namely the Dáil and the Seanad.  It is considered likely that a new referendum on the Eighth Amendment will be called, probably early next year.

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