Update on Life Issues – July 2015

 

Abortion

Abortion Statistics – England and Wales 2014

These were published on 9 June 2015.  What can said about them?  They are always depressing.  The total number of abortions performed during 2014 in England and Wales for residents was 184,571 plus 5,521 non-residents, making a total of 190,092 – just 708 less than the 2013 figure.  Of course, any decrease is welcome, but does this drop represent even a glimmer of long-term hope?  Hardly!  The 2014 abortion rate remained unchanged at 15.9 per 1,000 women aged 15 to 44.

 

The entire report for England and Wales can be read here: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/433437/2014_Commentary__5_.pdf/  The 2014 figures for Scotland are here: http://www.isdscotland.org/Health-Topics/Sexual-Health/Publications/2014-05-27/2014-05-27-Abortions2013-Report.pdf   Add the Scottish total of 11,475 to the 190,092 for England and Wales and the grand total of abortions performed in Great Britain during 2014 becomes a massive 201,567.

 

There are some notable 2014 trends.  For example, medical (as opposed to surgical) abortions, using principally the abortifacient drug Mifegyne also known as RU-486, accounted for 51% of the total – the first time they have been in the majority.  Ground E abortions for suspected handicap increased from 2,732 to 3,099.  While this figure may account for only 2% of the total it indicates society’s growing unease towards the disabled – 662 for Down’s syndrome and even 10 for cleft lip and palate.  Repeat abortions continued to rise with 37% of women having already had one or more abortions.  There were 2,399 abortions carried out on girls aged under 16.  Only 32% of abortions were performed in NHS hospitals, while 67% occurred in approved independent sector places under NHS contracts – whichever, the taxpayer is funding them.  The remaining 2% were privately funded.  Late abortions continued with a total of 1,193 being performed at 22 week’s gestation and over.  And as a result typically of over-zealous IVF, 132 abortions, usually at about 12 week’s gestation, were performed to reduce the number of developing foetuses – these are the so-called ‘selective terminations’.

 

Lastly, this Department of Health document blithely confirmed that, ‘Complications were reported in 330 cases in 2014, a rate of about one in every 550 abortions, slightly lower than the rate in 2013.’  I know this refers to acute medical complications.  But we all know that long-term medical and psychological complications, both major and minor, affect the majority of these 190,092 women.

 

Reversing RU-486 – the Abortion Pill
This is a fairly new, controversial procedure, which originated in the USA.  Think about this scenario.  A woman finds that she is unexpectedly and unwantedly pregnant.  She attends an abortion clinic, where she is told that she is only 6 weeks pregnant so she is offered the abortion pill Mifegyne, RU-486.  It consists of two stages – first, mifepristone, an abortifacient drug to kill the unborn child, and second, misoprostol, to cause the uterus to contact and expel the dead embryo or foetus.  She takes the mifepristone pill.

 

That night she is in tatters.  Yes, she is shocked to be newly pregnant and yes, her boyfriend has just dumped her and yes, she has a low-paid job and yes, her parents will probably not support her.  But, above all, she is now regretting her decision to abort.  What does she do?  She Googles ‘abortion pill reversal’ and finds, contrary to common knowledge, that the abortifacient effects of RU-486 can sometimes be reversed.

 

The concept is simple.  Mifepristone works as an antagonist of progesterone, a hormone essential for a successful pregnancy.  Its abortifacient action can be counteracted by quickly giving the woman large and repeated doses of progesterone, by mouth, vaginally, or by injection, every day until the end of the first trimester, that is about 14 weeks.  And it seems to work!  But it is a race against the clock the reversal procedure must be started no later than 48 hours after the mifepristone pill has been taken.

 

Back in 2007, Dr Matthew Harrison performed the first documented RU-486 reversal.  One of the current prime movers in this ‘abortion pill reversal movement’ has been Dr George Delgado, a general practitioner from Escondido, California.  In December 2012, he co-authored a paper with Mary Davenport in the Annals of Pharmacotherapy entitled, ‘Progesterone Use to Reverse the Effects of Mifepristone’, which stated, ‘It may be possible to reverse the effects of the abortion if the pregnant woman changes her mind, but that time is of the essence.’  The article reported the use of progesterone in six patients who had second thoughts after taking the mifepristone, but not the misoprostol.  Four of the six women carried their babies to term with no detected birth defects.

 

Since then, Delgado has created a worldwide network of almost 300 doctors who are willing to use the procedure under the collective title of Abortion Pill Reversal (APR).  By 31 December 2014, APR doctors had administered progesterone to 223 women, 89 of these patients went on to have normal deliveries and 75 were still pregnant.  Assuming those other pregnancies result in live births, then more than 60% of these patients will have avoided their previously intended abortions

 

But the procedure is contentious.  It is not 100% effective.  Some say progesterone therapy can cause ectopic pregnancies.  APR is little tested.  There have been no clinical trials.  It is not approved by the Food and Drug Administration in the US.  It is not recommended by the American Congress of Obstetricians and Gynecologists.  Side effects, though minor, include insomnia and nausea.  Critics maintain that there is no clear evidence that the procedure actually works.  For example, Dr Daniel Grossman, a fellow of the ACOG, has stated that, ‘For about 30% to 50% of women who take mifepristone alone, the pregnancy will continue.  It may very well be that doing nothing and just waiting to see what happens may be just as effective as doing this course of progesterone treatment.’

 

Nevertheless, the APR doctors press on.  They justify the continued use of this procedure on the grounds of five foundational principles:

1]  It is reasonable and appropriate to respect a woman’s right to choose to reverse a medical induced abortion.

2]  A woman should never be coerced into starting or continuing an abortion.

3]  Human beings are valuable and should be protected at all stages of their development.

4]  Mifepristone does not significantly increase the chances of birth defects.  Reversing a mifepristone medical abortion is within reasonable medical practice.

5]  Progesterone can reverse the effects of mifepristone and has been safely used in pregnancy for over 40 years.

 

So far the APR procedure is available only in the USA – details can be read at http://www.abortionpillreversal.com/  Whether APR ever comes to the UK depends upon the courage and response of our general practitioners.  Up to now, they have been singularly reluctant to get involved.

 

 

Assisted Reproductive Technologies

 

CRISPR – The New Bioethical Challenge

What an acronym!  It stands for Clustered Regularly Interspaced Short Palindromic Repeats.  It is pronounced ‘crisper’ and it could change the world.  So far it has sparked the biggest bioethical debate of the year, and one that is likely to last for at least the coming decade.

 

CRISPR is a revolutionary tool for editing genomes, that is, it can be used to add or remove genetic material with great precision.  It acts like a sat nav guiding to a predetermined location on the DNA chain of any cell’s nucleus – the required snip is then made by a pair of 'molecular scissors', a DNA-cutting enzyme called Cas9, hence the technique is often known as CRISPR-Cas9.  The technique was originally devised in 2012 by Emmanuelle Charpentier from the Hannover Medical School and Jennifer Doudna from the University of California, Berkeley and first described as, ‘A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity’ in Science (August 2012, 17: 816-21).

 

If gene therapy is the ultimate goal of genetic engineering, then CRISPR takes us a huge step nearer that target.  CRISPR has previously been applied to various animal and human cells, but in May 2015, a group of Chinese researchers published the first report of CRISPR editing of the genomes of human embryos.  Junjiu Huang and his colleagues at the Sun Yay-sen University presented their results in a paper entitled, ‘CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes’ in the journal Protein & Cell (May 2015, 6: 363-372).  The work centred on modifying the HBB gene, which codes for β-globin protein, but when  mutated it is responsible for β-thalassaemia, a potentially fatal blood disorder.  They injected human embryos with the enzyme complex CRISPR-Cas9, in order to bind and slice DNA at the specific ‘bad’ gene location and then repair it by introducing the ‘good’ gene.

 

In all, the Chinese workers injected 86 human embryos and then waited 48 hours for the embryos to grow to about the eight-cell stage.  Of the surviving 71 embryos, 54 were genetically tested.  This revealed that just 28 were successfully sliced, but only a few contained the replacement ‘good’ gene.  Such lack of success is serious.  As Huang stated, ‘If you want to do it in normal embryos, you need to be close to 100%.  That’s why we stopped.  We still think it’s too immature.’  Furthermore, they found that the technique produced a surprisingly high number of ‘off-target’ mutations caused by CRISPR-Cas9 altering other parts of the human genome – such mutations can be deleterious and may have occurred because the embryos were ‘abnormal’.

 

Nevertheless, this is undoubtedly landmark science.  As the authors noted, ‘Gene editing tools … hold tremendous promise for both basic research and clinical applications.’  Others have described the CRISPR-Cas9 technique as, ‘… a molecular biology breakthrough that could potentially lead to curing every major disease.’

 

But this latest form of genetic engineering is riddled with controversy.  So controversial is it that both the leading journals Nature and Science declined to publish this research.  First, it is germline (as opposed to somatic) gene therapy, that is, it is heritable, and therefore it again raises the spectre of consent from future affected generations, ‘designer babies’, ‘playing God’, and so on.  However, we are already halfway down that pathway because of the UK government’s foolhardy decision in February 2015 to allow germline gene therapy by its approval of so-called ‘three-parent’ IVF in order to combat mitochondrial diseases.  It was always going to be a simple legal and bureaucratic ‘hop and skip’ from modifying mitochondrial DNA to modifying nuclear DNA.

 

Second, any research involving human embryos is always divisive.  They should never be treated as mere biological material.  The Chinese group tried to avert such criticism by using ‘abnormal’, ‘non-viable’ embryos that had been fertilised by two sperm, which they obtained from a local IVF clinic.  Nevertheless, while such zygotes could not result in a live birth, they did undergo the first stages of human development.

 

Third, there is widespread fear that genome editing will go badly wrong.  And who knows what the grotesque outcomes might be?  Even the Chinese researchers stated that their results revealed serious obstacles to using the method in medical applications.  This technology is definitely not yet ready for testing to eradicate human disease genes.  But who can doubt that someone, somewhere will not attempt to use CRISPR-Cas9 prematurely, with no regard to its safety?  These are serious issues and already many bioethicists and governments are calling for a moratorium on this and other similar gene-editing techniques.  For example, John P Holden, the White House science advisor, has said, ‘The Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.’   And Francis Collins, the director of the US National Institutes of Health, has stated that the NIH would not fund such research.  Furthermore, on 17 June, the US House of Representatives introduced its 2016 spending budget which included a bill that would prohibit the US Food and Drug Administration (FDA) from using public funds to evaluate applications for clinical trials involving genetically-modified human embryos – even so, such research could still be privately funded.  Nevertheless, it does seem likely that this previous, worldwide, unwritten consensus that germline genetic modification is a step too far is likely to be ripped up, and soon.

 

Robert Pollack, professor of biology at Columbia University, in a recent letter published in Science encapsulated the unease of many both within and without the scientific community.  ‘This opening to germline modification is, simply put, the opening of a return to the agenda of eugenics: the positive selection of “good” versions of the human genome and the weeding out of “bad” versions, not just for the health of an individual, but for the future of the species …  Rational eugenics is still eugenics.  The best in the world will not remove the pain from those born into a world of germline modification but who had not been given a costly investment in their gametes.  They will emerge with the complexity of a genome different from what this technology will be able to define as “normal”I do not think anything short of a complete and total ban on human germline modification will do, to prevent this powerful force for rational medicine – one patient at a time – from becoming the beginning of the end of the simplest notion of each of us being “endowed by our Creator with certain inalienable rights.”’  On the other hand, the provocative Oxford bioethicist, Julian Savulescu, has asserted that, ‘Gene editing is a revolutionary technology, which potentially offers the next generation an enormous range of benefits.  It is important that bad arguments, empty rhetoric and personal interests do not cloud rational thinking and deny the next generation the enormous benefits potentially on offer from this type of research …’

 

We may be about to rush towards a gene-editing cliff.  The gene-editing genie is about to come out of the laboratory and into our world.  The world should first discuss the issues.  Even if the techniques are proved to be safe, should we modify DNA in human embryos, ova or sperm?  If so, under what circumstances?  Are there limits to improving public health?  What is the difference between a genetic cure and an enhancement?  How can we prevent gene-editing technologies from being abused?  How can scientists and the public communicate effectually?  Talk of a moratorium is all very well, but has one ever worked?  Will China even listen?  Is it already too late?

 

First Baby Born From Frozen Ovarian Tissue

At the age of 5, an anonymous Belgian girl was diagnosed to be suffering from sickle cell anaemia.  She needed a bone marrow transplant and her brother was a willing match.  But before the transplant could proceed she needed a course of chemotherapy, which would probably destroy her ovarian function, so the doctors removed her right ovary and froze some of its tissue.  Her remaining left ovary failed when she was 15 years old.

 

When she was 23, she wanted a baby.  Doctors then thawed and transplanted some of her frozen ovarian fragments.  Five months later, she started menstruating spontaneously.  When she was 27, she became pregnant naturally and in November 2014, she gave birth to a healthy boy – a world first.  While it is estimated that about 40 babies have already been born across the world using frozen ovarian tissue taken from older women, none has proved successful from such a young pubescent girl, as in this Belgian case.

 

Tangled IVF – Beat This Example!

I couldn’t make this up, even if I tried.  Here is another first for IVF practice in the UK.  Kyle Casson is 24 years old, he works in a supermarket and he is gay, but he wanted a child.  A relative offered to be a surrogate but eventually she pulled out.  Up steps Kyle’s mother, Anne-Marie Casson. 

 

Meanwhile, Kyle shops around for an ova donor and arranges for IVF and embryo transfer to his mum.  So, in July 2014, 46-year-old Anne-Marie Casson gives birth to Miles Casson by caesarean section.  It is, apparently, the first time in the UK that a single man has had a baby by surrogacy.

 

Now consider the relationship tangles, twists and knots.  Anne-Marie is the mother of Kyle.  She is also the mother and the grandmother of Miles.  Miles is both the half-brother and the son of Kyle.  Kyle is both the son and the ‘husband’ of Anne-Marie.

 

Now consider the legal tangles, twists and knots.  Under English law, Anne-Marie and her actual husband are the legal parents of Miles.  Kyle has had to apply for an adoption order.  Normally, a surrogate mother must hand over the newborn child to two parents.  Mrs Justice Theis stated that the Casson arrangement was ‘unusual’, but ‘entirely ‘legal’.  So the adoption proceeded.  The judge was impressed that Kyle had given his decision careful consideration.

 

Kyle Casson could not comprehend the ethical fuss.  He explained, ‘I understand that not everyone will agree with it, but they can have their opinions.  I have a son and I am very happy.  As long as people can provide a home, and they have the support, I don’t see why anyone should be denied the right to be a parent.  Regardless of sexuality, gender, as long as you can provide for the child, I don’t see what the problem is.  I paid for it myself, it’s not taxpayers’ money, I own my own home, I am going back to work.’

 

So there we have it, you bioethical fusspots.  Happiness, plus some cash, are the new arbiters of right and wrong. 

 

 

Stem-Cell Technologies

 

A New Type of Stem Cell

A new type of human stem cell, capable of transforming into a greater number of cell types than even embryonic, adult or induced pluripotent stem cells, has been reported.  It has been created by the addition of a factor called bone morphogenetic protein (BMP4) to human pluripotent stem cells.  Apparently it is totally totipotent.

 

The lead researcher in this work was R Michael Roberts, professor of animal science at the University of Missouri.  He has explained that, ‘BMP-primed cells represent a transitional stage of development between embryonic stem cells and their ultimate developmental fate, whether that is placenta cells, or skin cells, or brain cells.  We can use these new stem cells for future research to better understand how embryos are organized and what causes diseases like pre-eclampsia and other prenatal problems.’  The work was published in the Proceedings of the National Academy of Sciences (May 2015, 112: E2337-2346) as, ‘Heightened potency of human pluripotent stem cell lines created by transient BMP4 exposure.’

 

The findings show that rather than stem cells moving straight to their end products, such as liver or brain cells, they exist in a half-way house, a transitional state, or a number of transitional states.  Roberts commented, ‘We now have new stem cells that are easier to manipulate since they are already at the key transitional precipice before changing into placenta cells, skin cells or any other kind of cell that makes up the human body.’  Roberts’ hope is that such novel cells will advance progress in stem-cell research and healthcare.  This work used hESCs and iPSCs – human embryonic, as well as induced pluripotent stem cells – the former makes therefore it bioethically illicit.

 

And Yet Another Type

Juan Belmonte and his team at the Salk Institute of Biological Sciences, La Jolla, California have discovered what they have called, region-selective pluripotent stem cells (rsPSCs).  The news was reported in Nature on 21 May 2015 (521: 316-321) as, ‘An alternative pluripotent state confers interspecies chimaeric competency.’

 

These rsPSCs are stable, grow easily and more quickly than other stem cell types.  Moreover, they are more straightforwardly subject to gene-editing than other pluripotent cells, a property that may enhance their therapeutic value in regenerative medicine.  Their pluripotent properties are apparently tied to their physical location or ‘region’ rather than the usual time-related stage of development of other stem cells.  Remarkably when grafted into mouse embryos, these human rsPSCs began to develop into early-stage tissues that resembled the three major cell layers of the early human embryo – the ectoderm, mesoderm and endoderm – from which all tissues and organs in the body grow.  It is speculated that rsPSCs may pave the way to growing human organs in animals, such as pigs and cows.

 

It now seems as if unethical stem-cell researchers have at least two new weapons, derived from human embryos, in their armoury.  As any consequentialist will tell you, 'The ends never justify the means.'

 

And Yet Another Stem-Cell Triumph
Scientists in the UK will soon start human trials on artificial blood that has been grown in laboratories from stem cells. The ‘new’ blood will not be for general use, but rather for specific patients, such as those suffering from sickle cell anaemia or thalassemia, who require frequent transfusions.

 

The blood will be made from stem cells obtained from umbilical cords and from adult donors.  The harvested stem cells will be cultured for three weeks and then coaxed to become red blood cells.  Each stem cell is expected to produce about 10,000 red blood cells.  Dr Nick Watkins, assistant director of research and development at NHS Blood and Transplant, ‘We are confident that by 2017 our team will be ready to carry out the first early-phase clinical trials in human volunteers.’  Yet another triumph for non-embryonic stem cells.

 

More Stem-Cell Wrongdoing?

I am enamoured by stem-cell research – it can, with stem cells not derived from human embryos, be the most bioethically benign and wondrous source of healthcare therapies.

 

Yet the field seems to attract hordes of charlatans and crooks.  For instance, there are thousands of unidentified quacks around the world, operating in at least 100 clinics in China, and as many in the USA alone, who are largely unregulated and offering untested stem-cell treatments and fleecing the gullible.  Then there have been the named individuals like Robert Trossel, who ran clinics in Rotterdam and Wimpole Street and charged huge sums for pointless and dangerous treatments to vulnerable patients with multiple sclerosis.  The most famous stem-cell crook has been Woo Suk Hwang, the South Korean scientist, who claimed to have extracted stem-cell lines from cloned embryos.  He almost got away with it, but in 2005, the truth leaked out and his scientific reputation and his means of employment nosedived.

 

It is therefore somewhat alarming to learn that Hwang is still operating and has recently entered into a partnership with another medical maverick, the self-publicist, Shoukhrat Mitalipov, from the Oregon Health & Science University in Portland.  Together they are pursuing research into curing maternal line genetic diseases in China, where the regulatory laws are lax.

 

And there is now an even more disappointing case of alleged stem-cell wrongdoing.  It involves the surgeon, Paolo Macchiarini.  He came to fame in 2008 when he carried out the first transplant of an artificial trachea into Claudia Castillo which had been created using stem cells taken from her hip.  He is now accused of misrepresenting data in six published papers involving other recipients of such tracheas.  Apparently, these papers made these pioneering transplant operations sound more successful than they really were.  The 39-page accusatory report was published at the end of June. 

 

My disappointment is particularly pointed because I have used the Castillo case in lectures and in my Bioethical Issues book as a wonderful example of ethical adult stem-cell usage in regenerative medicine – however, there is no suggestion in these recent accusations that the Castillo therapy was other than 100% genuine.  Truth is the lifeblood of science – the merest whiff of falsehood can be calamitous and should be vigorously rooted out.  I do not want the magnificent benefits of legitimate stem-cell technologies to be even slightly tainted, let alone permanently stained.

 

Update on World’s First Embryonic Stem-Cell Trial

The Lancet (7 February 2015, 385: 509–516) contained the following paper, ‘Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies.’  It was from the team headed by Robert Lanza of Advanced Cell Technology, Marlborough, Massachusetts.  It reported results from the world’s first embryonic stem-cell trial.  The false starts, doubts and controversies over this controversial and experimental type of therapy are well known.

 

The ongoing trial consists of two patient groups.  In the first, nine patients with Stargardt's macular dystrophy have been given subretinal transplants of human embryonic stem cell-derived (hESC) retinal pigment epithelia.  In the second, another nine patients with atrophic age-related macular degeneration have had the same treatment.  Three dose cohorts (50,000, 100,000 and 150,000 cells) were used for each eye disorder.

 

Basically, this is the two-year follow-up report of a trial that started in July 2011.  The overall findings were that, ‘There was no evidence of adverse proliferation, rejection, or serious ocular or systemic safety issues related to the transplanted tissue.  Adverse events were associated with vitreoretinal surgery and immunosuppression.  13 (72%) of 18 patients had patches of increasing subretinal pigmentation consistent with transplanted retinal pigment epithelium.  Best-corrected visual acuity, monitored as part of the safety protocol, improved in ten eyes, improved or remained the same in seven eyes, and decreased by more than ten letters in one eye, whereas the untreated fellow eyes did not show similar improvements in visual acuity.  Vision-related quality-of-life measures increased for general and peripheral vision, and near and distance activities, improving by 16–25 points 3–12 months after transplantation in patients with atrophic age-related macular degeneration and 8–20 points in patients with Stargardt's macular dystrophy.’

 

The authors continue, ‘The results of this study provide the first evidence of the medium-term to long-term safety, graft survival, and possible biological activity of pluripotent stem cell progeny in individuals with any disease.  Our results suggest that hESC-derived cells could provide a potentially safe new source of cells for the treatment of various unmet medical disorders requiring tissue repair or replacement.’

 

First, the methodology seems largely harmless, which was the primary aim of these so-called phase 1 and 2 studies.  That must come as a great relief to Lanza and his colleagues because some previous embryonic stem-cell studies have gone biologically haywire.

 

Second, the enhancement results are certainly not as large as hoped for.  Only 56% (10 out of 18) of the patients’ eyes showed some improvement in visual acuity, 39% remained roughly the same and 6% got worse.  Some eye specialists believe it is too soon to say whether the visual improvements are real.  They maintain, for example, that the patients were not examined by independent specialists, eyesight in patients with low vision is notoriously difficult to measure, and placebo effects or unconscious bias on the part of doctors could be confounding factors.

 

All in all, I suppose this report is some sort of minor feather in the cap of the embryonic stem-cell researchers.  Certainly, the drug giant Pfizer has been impressed because it is planning to launch its own study to transplant larger patches of embryonically-derived retinal cells.  However, the big questions remain.  Why bother?  Why not simply use already-proven, bioethically-uncontentious, adult or induced pluripotent stem cells?  Why keep destroying human embryos?

 

 

Euthanasia and Assisted Suicide

 

Assisted Dying (No. 2) Bill 2015-16

The pro-euthanasia crowd have recently found a new champion, this time within the House of Commons.  After Lord Falconer’s Assisted Dying Bill ran out of time because Parliament was prorogued on 26 March, the focus has now switched to the Lower House.  Rob Marris, Labour MP for Wolverhampton South, came top of the June ballot for Private Members’ Bills and announced that he would present a Bill virtually identical to Lord Falconer’s.  Officially it is described as, ‘A Bill to enable competent adults who are terminally ill to choose to be provided with medically supervised assistance to end their own life; and for connected purposes.’

 

The Bill’s First Reading, merely a procedural formality, was on Wednesday 24 June.  The all-important Second Reading is on Friday 11 September.  MPs will on that occasion be able to debate for one hour and then vote.  This will be the first time an assisted suicide Bill has been considered in the Commons for 20 or so years.

 

How will the vote go?  Who knows?  But there is already mounting opposition.  When recently asked in Parliament for his view, the Prime Minister, David Cameron, stated, ‘I do not support the assisted dying proposals that have come out of the other place [the House of Lords].  I do not support euthanasia.  I know that there are imperfections and problems with the current law, but I think that these can be dealt with sensitively and sensibly without having a new law that actually brings in euthanasia.’  Mark Atkinson, the interim chief of the disability rights charity, Scope, has warned that, ‘Many disabled people are really worried about the legalisation of assisted suicide.  They are concerned that it will lead to them feeling under pressure to end their lives.’  Agnes Fletcher, director of Living and Dying Well, maintains, ‘The Bill contains very few explicit safeguards.’  The Care Not Killing Alliance, Not Dead Yet UK coalition and many other groups oppose the Bill because it would give doctors the right in law to cause the death of their most vulnerable patients – this, they say, cannot be either right or civilised.

 

The Second Reading on Friday 11 September poses a potential problem.  Many MPs travel home to their constituents on Fridays and so absenteeism in the House is likely.  You should therefore urge your MPs (unless they are rabid euthanasiasts) to rearrange their diaries to attend the debate and vote down this Bill.  I have written to mine asking if he still opposes the legalisation of assisted suicide, and if not, when can we meet?


Assisted Dying Bill [HL] 2015-16

Meanwhile, the dogged Lord Falconer has re-introduced his old Bill into the House of Lords.  It was given its First Reading on 4 June 2015.  The Second Reading has yet to be scheduled.

 

Access to Palliative Care Bill 2015-16

Baroness Finlay of Llandaff, the distinguished professor of palliative care, has responded by introducing the First Reading of her Bill on 1 June.  It is officially described as, ‘A Bill to make provision for equitable access to palliative care services; for advancing education, training and research in palliative care; and for connected purposes.’  The Second Reading has yet to be scheduled.  Although, if passed, it would apply only to England, it would be a positive counter to all the pro-death talk at Westminster and among the media.

 

Assisted Suicide (Scotland) Bill

On 27 May, this Bill fell at the Stage 1 debate in the Scottish Parliament on a free vote by 82 to 36.  It had proposed an ‘Oregon type system’ with trained ‘licensed facilitators’ to do the dirty work for mentally-competent adults, aged 16 and over, with a ‘terminal or life-shortening illness’ or a ‘progressive and terminal or life-shortening condition’, who had concluded that the ‘quality of their life is unacceptable’.

 

The Health and Sport Committee had previously given the Bill a good mauling and exposed many of its numerous shortcomings.  More than 15,000 Scottish people had signed a petition opposing its proposals.  Scottish First Minister and SNP leader, Nicola Sturgeon, along with 81 of her colleagues, eventually voted against it.  Such an emphatic defeat sends a strong message to both Houses at Westminster.

 

Euthanasia in Belgium

For those who naively think that assisted suicide legislation can be made prescriptive with water-tight safeguards and strict compliance, they should look to Belgium.  Belgium permitted voluntary euthanasia in 2002.  The unfolding story has been one of increasing numbers and widening scope.  First, the numbers.  In 2003, there were 235 officially reported cases, by 2012 that figure had risen six-fold to 1,432 and by 2013 it was 1,807.  In some regions of the country half of the cases have not been reported and a third are considered to be involuntary.  Between 2007 and 2013, the rate of euthanasia increased from 1.9 to 4.6% of all Belgian deaths. 

Second, the eligibility net has widened to include euthanasia linked directly to organ harvesting (so-called organ-donation euthanasia, ODE), joint euthanasia for elderly couples, euthanasia after a botched sex-change operation, double euthanasia for deaf twins because of their fear of failing eyesight, and euthanasia for a sexually-abused, anorexic woman.  Euthanasia for psychological suffering among the non-terminally ill has become de rigueur.  Then on 13 February 2014, the Lower House of the Belgian Parliament approved the world’s most radical extension of euthanasia law – by a vote of 86 to 44 with 12 abstentions – by granting the right of terminally-ill children, regardless of age, to request euthanasia.  Similar legislation exists in the Netherlands, though only for children over the age of 12.  In both countries, children require the additional consent of parents, doctors and psychiatrists.  This Belgian measure had been previously passed by the country’s Senate.  Then on Sunday 2 March 2014, King Philippe signed the Bill into law.  Can children understand the meaning and implications of euthanasia?  Even the legal age of consent to sexual intercourse in Belgium is 16.  Now comes news of the most recent and alarming downgrade.  Laura is a 24-year-old woman in Belgium who will be euthanased sometime this summer for purely psychological reasons.  She is not physically or terminally ill, but she has experienced suicidal thoughts since her childhood.  She claims, ‘Life, that’s not for me.’  And in Belgium, that is a sufficient reason for the deadly needle.

 

Herein, lies the wicked sting of legalising euthanasia.  Once it is permitted it becomes part of the medical and societal culture.  Throughout Belgium, euthanasia is now considered to be a legitimate option within end-of-life care.  And that massive unacceptable-to-acceptable transformation took only about 10 years.

 

 

USA and Elsewhere

 

US Abortions Continue to Decline
According to a new Associated Press survey, the rate of abortion has declined across almost all of the USA since 2010.  It has decreased by an average of 12% in both liberal and conservative-run states.

 

What are the causes?  They are difficult to tease out.   Laws in some states have made it either harder or easier to obtain an abortion or contraception.  Certainly there has been a fall in the teenage pregnancy rate, which reached its lowest mark for decades in 2010.  Pro-lifers maintain that more women are carrying unplanned pregnancies to full term because, they say, women have an increased awareness of the humanity of their babies before they are born.  So that in Indiana, Missouri, Ohio and Oklahoma – states notorious for being aggressively anti-abortion – abortion has dropped by 15% since 2010.  But in liberal states like New York, Washington and Oregon – states where it is easier to get abortions – the same declining trend is also evident.  Supporters of abortion rights say the fall is due to increased access to contraceptives and better sex education.

 

Take, for example, Oklahoma.  Here the rate fell by 19% between 2010 and 2013 after a new law required women to wait at least 72 hours before undergoing an abortion.  The state also banned a second-trimester abortion procedure.  Pro-lifers say it is these laws that have helped to increase public understanding of what abortion really means.  What else?   Some say that factors, such as national pro-life educational efforts and pregnancy support services, are making a difference by providing women with abortion alternatives.  Others say that pro-life prayer and educational campaigns outside abortion clinics have contributed to the downward trend.  Whatever the reasons, it is good news.

 

US State Abortion Restrictions Continue

The pro-life consensus in some states continues to promote pro-life laws.  Take, for example, New Mexico, a state that rarely makes the news.  On a Friday night in March, after some six hours of debate, New Mexico’s House of Representatives approved two Bills that, if enacted, will place limitations on abortion services and also affect the provision of medications, such as emergency contraception, aka the morning-after pill.

 

Thus, New Mexico's Representatives voted 42 to 26 to pass the Late-Term Abortion Ban Bill onto the Senate.  The Bill would bar abortions after 20 weeks except in certain cases, such as if the pregnancy was due to rape or incest.  The other Bill, passed by 39 to 28, would require abortion providers to notify the parent or legal guardian of any underage girl seeking a termination.  Both Bills would also allow doctors and healthcare professionals to refuse, based on religious or moral grounds, to perform procedures or dispense medication that could result in the termination of a pregnancy.


Obergefell vs. Hodges
Though these Updates on Life Issues are usually limited to topics of a bioethical nature, it would be churlish not to mention the ground-breaking case of Obergefell vs. Hodges and something of its likely fallout.

 

On 26 June 2015, the US Supreme Court ruled, by 5 to 4 votes, that all fifty States are now required to issue marriage licences to same-sex couples.  This radical decision may be regarded as just part of a worldwide wave of the redefinition of marriage.  After all, the UK (with the notable exception of Northern Ireland, which has rejected the idea four times in the last three years) has already done it, and so have dozens of other countries.  But there are serious and adverse consequences to this novel type of ‘marriage’.  Consider four of a bioethical nature.

 

First, married couples usually want children.  How will gay and lesbian couples fulfil this desire?  They will need either ova or sperm from some other adult.  This website has already traced several of the disastrous tangles of procreation and childhood with multiple parents – these will only increase.  Second, some of the above arrangements will require surrogate mothers.  Surrogacy is medically dangerous, bioethically unsound and socially exploitative.  This website has already traced several of the disastrous tangles of procreation ….  Third, the God-ordained, neat and wholesome structure of the traditional family – that threesome of father-mother-child – is now merely one of several other acceptable, but fragmented relationship configuations.  This website has already traced several of the disastrous tangles ….  Fourth, the legalisation of same-sex ‘marriage’ has dealt another hammer blow to the conscience of those who object.  We hear that the scruples of objectors will be protected, but for how long, and by whom?  Free speech and freedom of conscience will now be under even greater threat.  This website has already traced several of the disastrous ….

RU-486, Drones and Poland

Who could imagine these three words in the same sentence?  Sadly, it has come about.  The Dutch abortionist organisation, Women on Waves, the group that ran a ship offering terminations in international waters on the borders of countries where abortion is illegal, has devised a new headline-grabbing tactic. 

 

On Saturday 27 June, Women on Waves flew a drone across a river from Frankfurt an der Oder in Germany to land at Słubice in Poland.  It carried an unspecified number of the pills that make up the RU-486 abortion regimen, namely, mifepristone and misoprostol.  These drugs are legal in Germany but illegal in 90% Roman Catholic Poland, where the country’s strict pro-life laws allow abortion only in cases of rape or incest within 12 weeks of pregnancy, or within 24 weeks if foetal malformation is suspected, or later if the mother’s life is at risk.  Apparently, the drone landed successfully, two Polish women swallowed the pills and German police confiscated the drone controllers as well as some personal iPads.  It was, of course, a barmy publicity stunt – the German women could have walked across the bridge with the pills in their pockets.

 

Poland and IVF

In mid-June, the Polish parliamentary Lower House, the Sejm, approved a Bill that, for the first time, would provide statutory regulation of IVF.  IVF has been available in Poland for some 25 years, with state funding since 2013, but it has been largely unregulated.  Though the Bill was passed by 261 to 176 votes with 6 abstentions, it still needs approval by the Polish Senate and the President.  The debate has so far highlighted the ethical fault lines between the ruling Civic Platform Party and the conservative, Roman Catholic-dominated, Law and Justice Party.

The Bill would allow both married and unwed couples to be granted access to IVF if other treatments have not given results in 12 months, and they will be permitted to have up to six ova fertilised.  However, any unused embryos may be used by other women, but only after 20 years, and they cannot be destroyed.  Destroying embryos will be punishable by up to five years in prison.  The same Bill would also ban the cloning of human embryos, the manipulation of human DNA and techniques that would influence the gender of embryos.  Sometimes Poland seems such a sensible country, but it is now showing serious signs of plagiarising Western bioethical decadence.


When Dr Philip Nitschke Wins, We All Lose
In July 2014, ‘Dr Death’, this intrepid euthanasia advocate, had his medical licence suspended by the Medical Board of Australia.  He was alleged to have counselled 45-year-old Nigel Brayley from Perth, who was depressed but otherwise healthy, to take his own life.   Last December, Nitschke appealed against the suspension before a health profession review tribunal – it upheld the original decision.  Then earlier this year Nitschke appealed against that decision in the Northern Territory Supreme Court – on 6 July, his appeal was upheld.

 

This is not the end of the matter.  First, it is currently unclear whether the Supreme Court’s decision will automatically reinstate Nitschke’s licence – it only quashed the allegation that Nitschke posed ‘a serious and immediate risk to people’ because Nitschke and Brayley were not in a formal doctor-patient relationship and therefore a doctor's duty to 'protect and promote the health of individuals' did not apply.  Second, the Medical Board of Australia has another 12 complaints against Nitschke to investigate.

 

The man’s reach is worldwide and wriggly.  In April 2015, Nitschke was warned that he faced being arrested at Charing Cross police station over allegations that he had encouraged or assisted suicide in the UK – an offence that carries a prison sentence of up to 14 years.  However in June, the Metropolitan Police dropped that investigation.


 

 

Miscellaneous But Still Important

 

Out with Bolam – In with Montgomery

Few things within practical medicine are more important than the issue of informed consent.  Not so long ago, paternalism reigned in both the hospital and the surgery – the doctor knew, unquestionably, what was best for the patient.  Then came the Bolam test – would a doctor’s conduct be supported by a responsible body of medical opinion? 

 

Now comes the Montgomery doctrine.  It is derived from the case of Montgomery vs. Lanarkshire Health Board and the decision made by the UK Supreme Court on 11 March 2015.  Nadine Montgomery, who is just over 5 feet tall, suffers from type 1 diabetes – such women are likely to have bigger than normal babies as well as subsequent trouble during birth.  On 1 October 1999, she gave birth by vaginal delivery to her son, Sam, at Bellshill Maternity Hospital, Lanarkshire.  He underwent shoulder dystocia during delivery.  This is an emergency that occurs during labour when the baby's head has been born, but one of his shoulders becomes stuck.  It can injure the neonate’s shoulder nerves, perhaps leading to damage and even permanent paralysis of the arm.  In the case of Sam, it created oxygen deprivation during a 12-minute delay, which caused serious brain damage so that he now suffers from cerebral palsy.


The consultant obstetrician and gynaecologist in charge, Dr Dina McLellan, did not tell Montgomery of the 9 to 10% risk of shoulder dystocia and the hazards associated with her condition.  McLellan said that she did not routinely discuss the risk of shoulder dystocia with women with diabetes for fear that, if told, such women would opt for a caesarean section.  The Supreme Court declared that McLellan should have informed Montgomery of the risk and discussed with her the option of a caesarean section.  The seven judges declared that if a caesarean section had been performed, ‘It is not in dispute that the baby would then have been born unharmed.’  As a result, the Court awarded Mrs Montgomery damages of £5.25 million. 

 

Montgomery vs. Lanarkshire Health Board was a landmark ruling that is set to change the doctor-patient relationship throughout the UK.  The Supreme Court further stated that, ‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken.  The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.  The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or whether the doctor is – or should reasonably be – aware that the particular patient would be likely to attach significance to it.’ 

 

In other words, it is now for the patient, rather than the medical professionals, to decide upon the level of risk they wish to take in terms of a particular course of action, given all the information available.  And, that information cannot be presented simply by handing out printed leaflets – there must always be a two-way conversation between the doctor and patient, a personal dialogue.  Moreover, statistics alone are insufficient to determine whether a risk is significant for a particular patient.  And, a doctor’s duty is not fulfilled by bombarding the patient with technical information, which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.

 

In reality, Montgomery is a shift towards more patient autonomy.  The message for doctors and all healthcare professionals is this – know your patient and provide tailored information.  Montgomery will have ramifications for all aspects of medicine.  The law now requires that doctors must communicate clearly and pause and engage in discussion with their patients.  It will be interesting to see how it applies, for example, to women requesting abortions – will the doctors now fully inform and discuss with women the pro-life alternatives, the small physical, but much larger mental, health risks, the prospect of an abortion-breast cancer (ABC) link, the risk of prematurity with subsequent pregnancies, and so on?  We await a test case.

 

Obituary of John C Willke, a Resolute Pro-Life Campaigner

John C Willke was born on 5 April 1925 and he died on 20 February 2015.  He was the influential obstetrician, who was regarded by many as the ‘father of the pro-life movement’ in the USA and further afield.  He is survived by his three daughters and three sons, 22 grandchildren; and three great-grandchildren.

 

Willke, together with his constant companion, former nurse and wife Barbara, were the co-authors of the 1971 best-selling Handbook on Abortion and the 1985 book Abortion: Questions & Answers, which were translated into 32 languages and were responsible for educating millions around the world on the issue of abortion – I have both on my bookshelves.  The former was written on their kitchen table originally to educate their daughters and teenagers in general.  Their other major educational resource was a set of transparencies, known as the ‘Willke slides', which showed pre-natal development, as well as graphic pictures of abortions performed during all three trimesters.  The Willkes appeared frequently on the radio and television and lectured around the world.   Jack Willke was not only a doctor, he became a gifted educator, a skilful manager and an effective lobbyist.  He remained unfailingly gracious and polite, no matter how intense the disagreements – and he was embroiled with many!

 

John Charles Willke, known as ‘Jack’, was born in Maria Stein, Ohio, the son and grandson of doctors.  Unsurprisingly, he followed the family trade and he was awarded his MD from the University of Cincinnati in 1948.  He served in the Navy while at university and as an Air Force doctor in the early 1950s.  Then for nearly the next 40 years he practised as an obstetrician and family doctor in Cincinnati.  He was competent and apparently adored by his patients.

 

During the late 1960s, he became troubled by the increasing calls for US women to have the right to terminate their pregnancies by abortion.  He was strongly opposed to abortion and decided that he could no longer remain silent on the issue.  In 1973, after the landmark decision by the Supreme Court in the case of Roe vs. Wade, which effectively legalised abortion state-wide, he threw his weight and his remaining years into the anti-abortion movement.  He was to become one of its most controversial and polarising leaders.  Many loved him for his uncompromising pro-life stance – many hated him for it. 

 

The Willkes started small – he and Barbara first founded Cincinnati Right to Life.  Then Ohio Right to Life.  Then, along with Dr Carolyn Gerster and Dr Mildred Jefferson and others, the National Right to Life Committee (NRLC), now the USA’s oldest and largest anti-abortion organisation, of which Willke became a long-serving president.  He was also a founding member and long-standing president of the International Right to Life Federation and in 1991, the founder and president of the Life Issues Institute, a US educational organisation that aimed to reinvigorate the pro-life movement.  He realized that the old message, ‘It’s a baby, it’s a sin to kill it’ was falling on the next generation’s deaf ears – his abiding message was child- and mother-centred – ‘Love them both.’  He mixed easily with the lowly and the exalted.  He was responsible for the conversion of President George Bush from a pro-choice to pro-life position.  He also met with several popes, for he and Barbara were practicing Roman Catholics.

 

Everyone of Jack Willke’s calibre will court controversy – and he did.  He was strong-minded, he could be authoritarian and he divided the pro-life community.  Some criticized him because he allowed exceptions in abortion laws for cases of rape and incest.  Moreover, he disliked and distanced himself from the more aggressive, in-your-face tactics of displaying large, graphic images of aborted foetuses in public areas as well as protests, prayer vigils and pavement counselling as used by groups such as the Pro-Life Action League.  Yet, for the most part, he knew how to communicate the issues instinctively and effectively.  Even so, not all of his statements were evidence based.  For example, Willke controversially believed that female rape victims have natural physiological defences against pregnancy – in other words, they rarely got pregnant after such sexual assaults.  For this opinion, he was mocked by the medical establishment.  In 2012, this notion resurfaced when Todd Akin, a Republican Representative from Missouri, used it in an interview, and it caused him to lose his 2012 Senate bid.  The American Congress of Obstetricians and Gynecologists responded by stating that a woman who is raped, ‘… has no control over ovulation, fertilization or implantation of a fertilized egg’ and, ‘… to suggest otherwise contradicts basic biological truths.’

 

Yet his greatest legacy is that his labours saved the lives of unknown thousands of unborn children.  His Foreword to the Handbook on Abortion concludes, ‘If your mind is closed, don’t bother to read this.  If however, you are interested in a short, readable condensation of the world’s scientific literature as it pertains to the unborn and to many other answers to the abortion protagonists, then have a look.  Then – make up your mind!’   And John Willke did cause millions to change their thinking and defend human life from conception to natural death.  His calling as a medical doctor was in the true Hippocratic-Christian tradition – as a healer and a protector of all human life.  He will be missed and never replaced.  May there be many new abortion abolitionists who stand on Jack Willke’s shoulders.


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