Update on Life Issues – October 2015

 

Abortion

 

The Planned Parenthood affair

For the last few months, the abortion issue has been dominated by one story – that of Planned Parenthood of America, commonly known as simply Planned Parenthood.  The mother organisation, IPPF, International Planned Parenthood Federation, has its roots in Brooklyn, New York, where Margaret Sanger opened the first birth-control clinic in the US.  In 1921, she founded the American Birth Control League which, in 1942, changed its name to Planned Parenthood.  IPPF now works in 170 countries worldwide, with 30,000 staff and millions of volunteers.  Its mission includes, ‘… sexual and reproductive health and rights concerns’, which is code for mass abortion.  For example, in the US, Planned Parenthood performs some 300,000 abortions annually.  In the UK, the pro-choice Family Planning Association, fpa, is a Member Association of the IPPF.


During 2013, David Daleiden, often described as an anti-abortion activist, founded the Center for Medical Progress (CMP).  He then set up a bogus biomedical research company, called Biomax Procurement Services, as a cover to enable CMP members to pose as buyers of foetal tissues and organs.  They set up a series of undercover stings in which they secretly filmed Planned Parenthood officials purportedly discussing the illegal sale of aborted baby parts, foetal tissues, to medical researchers for financial gain.  In July 2015, the CMP started releasing these videos allegedly showing examples of these illegal transactions.  The videos in question can be viewed here.


The story has caused not inconsiderable uproar across America.  The pro-choice movement has denounced the accusations as untrue and the videos as deceitfully edited.  An editorial in The New England Journal of Medicine, described the CMP videos as part of a ‘campaign of misinformation’ by an organisation intent to ‘twist the facts.’  Others have accused pro-lifers of stupidly anthropomorphizing foetuses and embryos, as well as CMP’s activities as ‘corporate espionage’.  Planned Parenthood has maintained that the financial discussions were about shipping and handling costs to biotech companies, not profit - ‘There is no financial benefit for tissue donation for either the patient or for Planned Parenthood.’  Cecile Richards, president of Planned Parenthood, has sought to placate those women who have consented to post-abortion tissue donations by declaring, ‘Your commitment to lifesaving research, developing treatments for diseases like Parkinson's and Alzheimer's, is important and compassionate.’
  

The pro-life movement has used the affair to expose the physical, ethical and financial horrors associated with abortion.  David Daleiden accused Planned Parenthood of altering its surgical abortion procedures in order to acquire the higher priced intact foetuses and entire tissues, such as brains and livers.  He has stated, ‘Planned Parenthood is a criminal organisation from the top down and should be immediately stripped of taxpayer funding and prosecuted for their atrocities against humanity.

 

The action has more recently moved from the media and into the courts and government.  The National Abortion Federation is suing CMP and Planned Parenthood is also considering legal action.  In September 2015, a US court ruled that Daleiden and the CMP must submit private documents and details of the video stings along with their full raw footage.  StemExpress, the tissue procurement company that works with Planned Parenthood and is featured in some of the CMP videos, has also obtained a similar court ruling.  Congressional investigations have started.  There has been a concerted push to cut state funding of Planned Parenthood, which currently amounts to $0.5 billion of taxpayers’ money each year.  A defunding Bill was proposed in the US Senate, but it failed to pass on 3 August.  Planned Parenthood is now under investigation by the House of Representatives' Oversight and Government Reform Committee.  A September interim Memorandum from that Committee’s chairman, Jason Chaffetz, stated, ‘Planned Parenthood and its affiliates have spent millions in recent years on “blowout” parties, first-class travel and “lucrative” salaries.’ 


By mid-October,
 Planned Parenthood had announced that its health centres would no longer accept financial reimbursement for procuring post-abortion body parts.  Big deal!  The horror is that they still find cutting up unborn children and salvaging their bits and pieces to be an acceptable practice.  Pro-life organisations called this belated 'policy change' a PR stunt and little more than a last-ditch effort to avoid prosecution while retaining its massive funding from US taxpayers.  This affair is far from over - as they say, ‘the case continues.’


Sex-selection abortions

In November 2014, Fiona Bruce MP introduced her Abortion (Sex-Selection) Bill in the House of Commons.  Considerable evidence had been previously produced by The Daily Telegraph undercover reporters along with anecdotes from the general public that abortions on the grounds of gender – typically female – were illegally taking place in the UK.  The Bruce Bill got lost in a mire of procedural ambiguities.  It was eventually shuffled into the Serious Crime Bill.  The only positive outcome was that the Department of Health was mandated to examine the various claims.

 

In August 2015, the Department published its required report, Assessment of termination of pregnancy on grounds of the sex of the foetus - Response to Serious Crime Act 2015.  The document can be read here.  And its conclusion?  ‘However, we have found no substantiated concerns of gender abortions occurring in England, Wales and Scotland.’  So, gender-specific abortions occur elsewhere in the world, but not in the UK.  Do you believe that?  Statistics rarely tell the whole truth.

 

Assisted Reproductive Technologies

 

Adverse IVF incidents

Is all going well in the IVF clinics across the UK?  Not entirely.  In September, the HFEA published its second annual report entitled, Adverse incidents in fertility clinics: lessons to learn.  It covers the year 2014 and can be read here.


A total of 465 incidents were reported.  Of these, two were classified as grade A, the most serious, with 166 grade B incidents and 232 at grade C.  Grade B incidents include events such as severe or critical ovarian hyperstimulation syndrome (OHSS), the loss of a patient's embryos and breaches of confidentiality.  Grade C incidents occur, for example, where one of a patient’s ova may be rendered unusable but others remain, so treatment is not completely futile.  And there were 65 other reports that were unclassified.

 

One of the grade A incidents involved a patient who became pregnant with twins after an embryo affected by chromosomal translocation was inadvertently transferred, despite undergoing screening for the genetic condition using pre-implantation genetic diagnosis (PGD), or as the HFEA Report stated, ‘… the pregnancy was affected by an unbalanced chromosome translocation.’  The incident occurred at CARE Fertility Nottingham, which had used a third party laboratory, Genesis Genetics Europe (GGEu), to test the embryos.  A failure of the technology rather than human error was blamed.  Of all the seven adverse incidents relating to misdiagnosis by PGD since 2009, six have occurred with CARE Fertility Nottingham.

 

The second grade A incident took place at the South East Fertility Clinic in February 2014.  Seven patients treated on the same day underwent ova collection followed by successful fertilisation.  However, it was later noticed that none of the embryos developed properly.  The HFEA concluded that they were probably placed in petri dishes with 'sub-optimal media'.  No pregnancies resulted from the treatments and the Clinic offered the affected patients another cycle of treatment free of charge.

 

Perhaps the above needs a little context.  The total incidents reported represent approximately 1% of the 60,000 IVF treatments carried out by UK fertility clinics each year.  And the numbers were slightly down on the previous year.  Even so …

 

HFEA in trouble again

The most senior family judge in England and Wales, Justice James Munby, has castigated the HFEA and several IVF clinics for their ‘widespread incompetence across the sector’ and ‘alarming and shocking’ failures that have left dozens of couples who had a child through artificial insemination by donor (AID) in doubt about whether the child legally belonged to both of them.

 

The Human Fertilisation and Embryology Act 2008 and clinic licensing conditions require that both partners be given information, offered counselling, and sign consent forms before beginning treatment to ensure that both become the child’s legal parents.  But 51 of the 109 clinics licensed by the HFEA had ‘anomalies’ in their records, said Sir James Munby, president of the High Court’s family division.  These included essential documents known as WP and PP forms not signed, not fully completed, filled in by the wrong person, or with missing pages.  It is understood that 85 other couples could have their parentage called into doubt because of similarly inaccurate paperwork.

 

Sir James stated, ‘The picture revealed is one of what I do not shrink from describing as widespread incompetence across the sector on a scale which must raise questions as to the adequacy if not of the HFEA’s regulation then of the extent of its regulatory powers.  That the incompetence to which I refer is, as I have already indicated, administrative rather than medical is only slight consolation, given the profound implications of the parenthood which in far too many cases has been thrown into doubt.’  These scathing remarks came as a result of cases brought by five heterosexual couples and two same-sex couples who were the victims of bureaucratic ineptitude.  After the babies were born the couples learned that they might not be the legal parents.  The judge granted legal parentage to all the parents, saying that they had already suffered greatly.

 

And the HFEA’s response

On 11 September, the HFEA issued the following response to the above cases: ‘These hearings have no doubt been very stressful for the families involved and today’s judgment is clearly welcome news for them.  They rightly assumed that legal parenthood was beyond doubt; finding out that it was not must have been very upsetting.

 

‘The law was changed in 2009 to allow unmarried partners of women having treatment with donor sperm to become the legal parent at birth.  Whilst this only affects a small group of patients, that is no excuse for getting it wrong.  As the regulator, we have worked hard to make sure that clinics understand this complex aspect of the law, but we should have done more to make sure clinics were getting it right.

 

‘After the first case of this kind came to light, we asked clinics to review all relevant patient records.  We are working with the clinics involved to make sure affected patients are contacted and offered the support and advice that they need.  We have also changed our approach on inspection to make sure that consent processes in clinics are tightened up and that staff are properly trained

 

‘We will review the action we have already taken, alongside the Judge’s recommendations, to minimise the risk of this happening again.  All fertility patients have a right to expect that matters as important as consent to parenthood are handled professionally by their clinic.’

 

I can detect no sense of contrition or apology, real or inferred, in this HFEA statement.  Perhaps saying 'sorry' to these people would be too much of an admission of the regulator's incompetence.  Big-time administrators often have a terrible record of human empathy.  Just how inept is the HFEA?  Why cannot it regulate properly?  Does it not understand the law?  How far does this ‘widespread incompetence’ spread?  Does it go beyond this numerically tiny sector of AID into the enormous sphere of IVF and embryo research?

 

Womb transplants

Around one in 5,000 women are born without a womb, while others lose theirs due to cancer or other medical conditions.  The once imaginary treatment of a womb transplant has now become a reality.  In October 2014, a 36-year-old woman in Sweden became the world’s first person to give birth after a womb transplant.


Now doctors in London have been granted permission to carry out the UK's first trial in which ten women will receive womb transplants.  If successful, the first baby could be born in late 2017.  Dr Richard Smith, a consultant gynaecologist at the Queen Charlotte's and Chelsea Hospital in London, who has been working on the project for 19 years, will lead the transplant team.

 

The procedure is not without ethical and practical problems.  IVF, with all its attendant bioethical predicaments, was used in the Swedish trial.  In addition, immunosuppression drugs are required to prevent the womb being rejected, but to avoid their harmful long-term usage, the womb is surgically removed once the birth has occurred.  The alternative remedies to such childlessness are surrogacy or adoption – the latter is the only recommended route for the morally sensitive.

 

Britain’s national sperm bank waiting for donors

A change in UK law in 2005 removed anonymity for sperm donors and this is thought to be the cause of a recent dearth of volunteers.  Demand for donated sperm has soared because more and more same-sex couples as well as single and older women want children.  The UK’s answer has been the establishment of its first sperm bank, which was opened in October 2014, at a cost of £77,000 at the Women’s Hospital, Birmingham, amid much media razzmatazz.

 

One year on, only nine men have registered as donors.  The bank is now planning a recruitment drive.  Its outspoken chief executive, Laura Witjens, thinks that appealing to male pride with a ‘superman’ message may be an effective way to boost donations.  She believes, ‘If I advertised saying “Men, prove your worth, show me how good you are”, then I would get hundreds of donors.’  Who is she kidding?  We shall see by October 2016.

 

'Three-parent' IVF superseded?

This contentious procedure, also known as mitochondrial donation, approved by Parliament in February and thus making the UK the first country in the world to allow the creation of babies with DNA from three people as well as permitting unethical germline genetic modification, may yet become history.  A novel method has been reported, in Nature as ‘Metabolic rescue in pluripotent cells from patients with mtDNA disease’, which can be read here.  Mitochondrial diseases, like muscular dystrophy, may possibly have a new cure.

 

The study, from the Oregon Health & Science University, has shown that people suffering from mitochondrial diseases can still produce healthy mitochondrial DNA, which may be used to remedy the defects.  In other words, genetic material from a third person may not be necessary.  Mothers at risk of passing on mitochondrial diseases may be able to use their own healthy mitochondria to repair their ova.

 

The researchers, led by the controversial and sometime maverick Dr Shoukhrat Mitalipov, of the University’s Centre for Embryonic Cell and Gene Therapy, showed that when skin cells from patients with a mitochondrial disease were converted back to induced pluripotent stem (iPS) cells, some of them were free from mutations.  These corrected stem cells can then be multiplied and transplanted back into the body.  Exciting stuff?  Yes, but so far the work has been in vitro it has yet to be tested in animals. let alone human patients.  And while the technique using iPS cells is bioethically sound, the team also used cells obtained by somatic cell nuclear transfer (SCNT), the bioethically unsound cloning technique.

 

So you thought you knew about human embryo development

OK, you know that when one human sperm penetrates one human ovum, a one-cell zygote results and a new human being is under way – that’s good GCSE Biology.  But the wonder of this fertilisation marvel is amplified by some research conducted in Sweden and published in Nature Communications and available here.


The earliest hours of human development are utterly fascinating.  How does one cell begin its journey to a full grown adult?  How do the zygote’s 23,000 genes control this development?  About 24 hours after the zygote is formed, it divides into two cells.  At the end of day two, there are four cells, and by day three there will be eight.  This is the biological processes of cell division.  And it continues to produce the estimated 100 trillion cells of the human adult.  Alongside cell division is the process of cell differentiation whereby some of these cells become bone or hair, blood, kneecaps, and so on, under the direction of these 23,000 human genes.  But this recent Swedish research has demonstrated that there is not a genetic free-for-all.  Rather there is a tightly-ordered sequence of genetic activity.

 

The Swedish team, headed by Juha Kere of the Karolinksa Institute, found that only 32 of the 23,000 genes were switched on two days after fertilization.  By day three, 129 genes have been activated.  Kere called these genes ‘the ignition key’ of human embryonic development.  Yet so much is not known seven of these 129 genes were previously unknown.  Some of these unfamiliar genes were found to interact with ‘junk’ DNA, which has long been thought to have no biological function.

 

So early human development does seem to display an unexpected parsimony.  Ultimately, to produce the fully-developed unborn child, thousands of genes are involved, switching off and on in a complex choreography, a biological ballet.  But it seems that on day one, only 32 genes start the motor and by day three just 129 are needed to keep it running.  Early human life is indeed a fascinating mystery.


Understanding the biology of these first few days of life could explain the possible roles of so-called ‘junk’ DNA, it could explain the process of induced pluripotent stem cell creation, it could explain some forms of infertility, it could explain the genesis of some genetic diseases, and so on.  It’s important to know – such a search for understanding is at the heart of good science.  Such searching is a wonderful, God-given, human attribute.

 

Sadly, there is a downside to this work.  These insights came at a bioethical price because the researchers used 348 single cells (oocytes and zygotes) and blastomeres (3-day-old embryos), all of which had been apparently been donated for this research.

 

Stem-Cell Technologies

 

Yet another adult stem-cell treatment?

Thousands of people suffer from chronic pain caused by type 2 diabetes, surgical amputation, chemotherapy and many other conditions that current painkillers bring relief for only a short time.  A simple stem-cell injection may bring relief for more than a month.

 

A paper by Ru-Rong Ji and his team at the Duke School of Medicine in the Journal of Clinical Investigation (abstract available here) showed that injections of adult stem cells, specifically bone marrow stromal cells (BMSCs), relieved neuropathic pain caused by nerve damage in mice.  Moreover, this study elucidated the therapeutic mechanism – the injected BMSCs translocate adjacent to the damaged nerve cells in the spinal cord and secrete TGF-β1, a protein molecule known to potently inhibit neuropathic pain.


Professor Ji commented, ‘This analgesic effect was amazing.  Normally, if you give an analgesic, you see pain relief for a few hours, at most a few days.  But with bone marrow stem cells, after a single injection we saw pain relief over four to five weeks.’  Now the work needs to shift from mice to men.


Mitochondrial donation regulations

In mid-September, the HFEA published new draft guidelines for mitochondrial donation, or ‘three-parent’ IVF.  The labyrinthine regulations (see here) will come into force on 29 October 2015 when the HFEA will issue, ‘… a Clinic Focus article and Chair’s letter setting out the final processes, systems and guidance for regulating mitochondrial donation.’

 

There is still far from any unanimous agreement that such potential therapies will be safe, even advisable.  Some biologists think that ‘foreign’ mitochondrial genes from the donor might interfere with the expression of the nuclear genes of the host, in unpredictable, and perhaps dangerous, ways.  Then there is the ethical objection that this sort of mitochondrial tinkering will lead to full-scale germline manipulation – the old slippery slope argument.  ‘No’, says the HFEA.  It maintains that licence applications will be narrow and their practical oversight will be strict.  Oh yes?  And how will such crass comments prevent scientists trespassing into immoral scientific endeavour?  It's a mystery.

Embryonic stem-cell trial
The London Project to Cure Blindness was established a decade ago with the aim of reversing vision loss in patients with ‘wet’ age-related macular degeneration (AMD).  In August, the Moorfields Eye Hospital announced that the first surgery of a novel treatment had been successfully performed on a 60-year-old woman patient.  So far no complications have been reported.  This news was greeted by an over-excited media suggesting that a miracle had been performed, the blind will now receive their sight.  The truth is that any outcome in terms of visual recovery, in just this one patient, will not be assessed until at least December.

 

Nevertheless, this surgical progress has been sufficient to prompt a larger trial – ten patients will now undergo the procedure over the next 18 months.  This involves surgically transplanting retinal pigment epithelial cells, derived from human embryonic stem cells, into the back of the diseased eyes.

 

This is not the first use of embryonic stem cells in the UK.  In 2012, patients with Stargardt's disease were injected with embryonic stem cells in a phase 1 safety trial carried out in the US and at Moorfields.

 

But why use embryonic stem cells for AMD?  Some 40 AMD patients have already been treated at Moorfields with adult stem cells taken from their own eyes.  Even the lead scientist of that trial, Professor Lyndon Da Cruz admitted, ‘We saw extraordinary recovery, with some people being able to read again and drive, and that recovery being sustained for years.’  But he complained that using the patient's own stem cells was complex and carried risks, and so the London Project has also opted for this embryonic stem-cell trial.  It is a disappointing development.

 

Yamanaka seeking cures for the incurable

The following is an interesting excerpt from a recent keynote speech given by Shinya Yamanaka, the discoverer of induced pluripotent stem (iPS) cells, the winner of the 2012 Nobel Prize for physiology or medicine, and currently the director of the Kyoto University Center for iPS Cell Research and Application (CiRA).  It was originally published on 24 September in Yomiuri Shimbun (The Japan News).

 

'In middle school and high school, I participated in judo, and at university I played rugby, so I suffered many injuries.  I had broken bones more than 10 times, and every time I received treatment from orthopaedic surgeons.  It was natural that I wanted to become an orthopaedic surgeon after graduating from medical school.

 

Through clinical experiences as a doctor, I realized that many patients suffer from intractable diseases or injuries such as spinal cord injuries which can’t be cured even by skilful orthopaedic specialists.  I wanted to find a cure for such patients in the future, and thought I had to study basic medical science to do so.

 

After working as a medical intern for two years, I entered graduate school, starting my career as a researcher.  After four years at the school, I went to the United States to receive more training as a researcher.  There I could learn a lot of important things.  One of them is the motto “Vision and Hard Work,” which I was taught as a key to success.

 

My future “vision” is to provide cures for people suffering from currently incurable diseases and injuries, such as spinal cord injuries, by utilizing iPS (induced pluripotent stem) cell technologies.

 

In the United States, I knew about embryonic stem (ES) cells a type of pluripotent cell created from a mouse embryo. ES cells can be increased indefinitely and transformed into various cells.  I was fascinated by their mysterious functions.  Back in Japan, I had a tough time as my research gained no one’s understanding.  It almost made me give up on my research.

 

Around that time, however, researchers in the United States succeeded in creating ES cells using human cells.  This achievement brought a global rise in expectations for the technology’s application to regenerative medicine, and I was encouraged that my research might become of use.  I later would have my own laboratory at the Nara Institute of Science and Technology, where I was given opportunities to advance my research.  There is much opposition to human ES cell research because the cells created from a human embryo have the potential to grow to be a baby if they are placed in a womb.  So my laboratory team set a goal of developing pluripotent cells without using embryos.

 

We discovered genes that work as a switch for somatic cells to transform into cells in a fertilized egg-like phase.  At Kyoto University, we succeeded in creating iPS cells from mouse cells in 2006, and from human skin cells in 2007.

 

We are working to apply the iPS technology for two types of medical use. In the first instance regenerative medicine we cultivate cells in a healthy condition outside the human body and transplant them into people suffering from illness.  For the second drug research and development we re-create disease conditions by using iPS cells to figure out the cause of diseases and develop drugs to slow disease development.

 

We publish papers on basic research, but our final goal, and mission, is to realize clinical applications of the technology.’

 

Euthanasia and Assisted Suicide

 

Assisted Dying (No. 2) Bill 2015-16

Friday 11 September was a red-letter day.  It was the day of the debate and vote in the House of Commons on this alarming Bill.  Anxiety was widespread and palpable.  It was a Friday, traditionally the day when MPs go home to their constituencies.  It was a Private Member’s Bill, typically of minor importance and of unlikely progress.  It was a free vote, and the ethical stance of the new batch of MPs on any such conscience issue was entirely unknown.

 

The Bill was sponsored by Rob Marris, Labour MP for Wolverhampton South West.  He had inherited it from Lord Falconer’s recently miscarried Bill in the House of Lords.  Moreover, Dignity in Dying, the pro-suicide group, has thrown its considerable organisational and financial weight behind this House of Commons attempt.  But the group became curiously quiet in the days leading up to the Great Debate – had its lobbyists forecast bad news?  And the media were also unexpectedly muted.  The Sun came out in favour of the Bill.  Of the medical journals only The Lancet declared itself, in a weaselly, anti-Christian piece entitled ‘Fibbing for God’ by its editor-in-chief, Richard Horton, to be mildly supportive.  And all this despite the emotive headlines generated during August by the deaths of the healthy, 75-year-old, ex-nurse Gill Pharaoh at the Lifecircle ‘clinic’ in Basel and the terminally-ill, 68-year-old, mountain-climbing carpenter Bob Cole at the Dignitas ‘clinic’ in Zurich.

 

On the day, as many as 85 MPs had asked to speak.  The debate started at 09.49 and within a few minutes of Mr Marris’s dogged opening remarks it became clear which way the House was swaying – numerous points of order were raised challenging his arguments and assumptions.  And so the opponents of the Bill continued to lay out their case.  It was all authoritative, polite and instructive.

 

At 14.07, after more than four hours of debate, the vote was called.  At 14.21 the result was announced – Ayes, 118 and Noes 330, a majority against the Bill of 212.  There was tangible relief.  The Bill had failed, danger had been averted, good medicine had been reinstated, the vulnerable had been protected.  The astonishing margin of defeat was slightly greater than that of 1997, when MPs last voted on the issue.

 

The entire debate can be read here.  There were many notable orations.  I thought the finest was by Dr Philippa Whitford, the new SNP MP for Central Ayrshire and a cancer surgeon.  Here is the whole of her speech, delivered without notes, as recorded in Hansard.


‘I do not think anyone doubts the views that have made all of us give up a Friday to be here; everyone is here because they are concerned about the suffering of others and we want to alleviate it. We just do not agree about how we should go about it.

 

I believe that this is not just a tidying up of a small legal anomaly. It is, rather, a crossing of a Rubicon, as was mentioned earlier. It is changing and legalising the killing of one person by another, regardless of the reasons why we would want to carry that out.


The Bill’s weaknesses have been mentioned, such as the problem of finding general practitioners who would write a report. In actual fact, quite a lot would be willing to do that, but not so many would be willing to be involved in the act of assisted suicide. Where would the independent expert be found? Some 96% of palliative care specialists are utterly against this Bill. They object to the name of it; they consider what they do is assisted dying, and what this is is assisted suicide.


I do not want to talk about the small print, however. That will be explored over the day. My objection is basically in principle. Many Members will be aware of my interest; as a breast cancer surgeon for 30 years, I have been involved in the journey to death of many patients, but as a doctor I have never considered that death was a good treatment for anything, no matter what was wrong with anyone.

People would choose such an option for lots of reasons: the fear of being a burden, the fear of dying, and most of all the fear of suffering. The responsibility to deal with that lies with us. Who is making them feel that they are a burden—is it their family or their friends, or is it society? Who is letting them down in their palliative care? It is us. As the hon. Member for Totnes (Dr Wollaston) mentioned, the services are patchy in some areas. Not everyone has access to palliative care, but I started out in 1982 when women did not know when they went into theatre that they had breast cancer because we did not have the ability to diagnose it. I worked for an eminent professor in Glasgow, and we lived in the ward in those days, and I watched patients come back from theatre having had the lump removed. If it was cancer their breast was removed, and that was it—no choice. They found out they had cancer by groping themselves on the trolley, because if they had a lot of bandages and a drip, that meant they had lost their breast and they had cancer.

Watching people die of cancer was awful at that time. They were cachectic, they were in pain, and we had very limited hospice and very little palliative care support in the hospital. But 30 years later that has changed. Whereas 40% of patients would live 10 years then, now 80% do so. Our patients know exactly what operation they are going in for. They have hours of discussion with us, and until a few years ago I would have been involved in their journey if that cancer came back, in their palliation and in their terminal care.

That journey can lead to a beautiful death. The event that had the biggest impact on me as a junior doctor was the death of a lady whom I had looked after for many months. When I came on to the ward that night, the nurses said, “I think Lizzie’s going.” She was curled up in her bed, obviously quite upset, and when I asked her what was wrong, she said she was frightened and she did not know what she had to do. I said, “You don’t have to do anything. You just have to relax. You just have to let go.” We had the family in. West of Scotland male is not good on emotion or openness, so I took her son in and I spoke to her again about what was happening to the point where he could tell her that he loved her and how much he was going to miss her. I went for my tea, and when I came back she was sitting up holding court with the whole lot of them. I thought, “Oh no, we’ve called it wrong”, but she was gone in an hour, and it was beautiful. That made me commit to working with cancer patients. If I had not made it as a surgeon—which, as a woman at that time, I was told flatly that I would not—I would have gone into palliative care.


I have seen change in the journey for patients. We heard the hon. Member for Mid Bedfordshire (Nadine Dorries) describe the last two weeks of the life of her friend, and that is something that we see repeatedly—that the patient is ahead of the family. We are always utterly open with patients. We no longer have a situation in which a family member says, “Don’t tell my mum. Tell me, but don’t tell her.” The patient will always know, because the fear is that when they see their death coming, they will know that everyone has lied to them and they will be on their own.

My job was not just to look after the patient; it was to look after the whole family. All these illnesses are diseases of the whole family, and we want the family to be left with the knowledge that they did everything they could and were able to express their love at the end of their loved one’s life. Things have changed for cancer patients. I have not had a cancer patient ask me for a quick way out, an escape, for decades. We need to ensure that palliative care is offered to people with degenerative illnesses, of which we are all afraid.

When the public support this measure, they are not actually thinking about the last six months of a terminal illness; they are thinking about Alzheimer’s, about motor neurone disease and about Parkinson’s, none of which the Bill would address. It is therefore inevitable that this would migrate. As the hon. Member for Totnes said, we should support palliative care and we must ensure that it is available to people who are dying, regardless of their illness. We need to change our tone towards the people who live in our society, so that old and vulnerable people no longer feel that they should get out of the way.

All our horizons will narrow as we get older. Someone who was hill walking when they were 20 might not manage to do so when they are 80. I have seen patients who are grateful to be at home being wheeled out on to the patio in the sun and having a good blether with their son who has come home from London. They consider that a good day. We might consider it horrific, looking at it in advance, but when we get there we will have changed. We should support letting people live every day of their life until the end, and make sure that, as legislators, we provide the means for them to live and die with dignity and comfort. We should not say, “When you can’t thole [Scots for ‘bear’] it, take the black capsule.” We should vote for life and dignity, not for death.’

This was the eleventh time in the last twelve years that the legalisation of assisted suicide has been attempted and defeated in the UK.  The Scottish Parliament and the National Assembly for Wales have both recently rejected the idea.  Is this recent overwhelming defeat at Westminster the end of the matter?  No way!  True, the issue may not come to Parliament again for perhaps the next five or ten years, but its supporters will not admit defeat.  The CEO of Dignity in Dying, Sarah Wootton, described the result as an ‘outrage’ and scolded MPs for being ‘ridiculously out of touch’.  Supporters of assisted suicide will now almost certainly pursue their cause, case by case, through the Courts, though we all know that ‘hard cases make bad law’.  At least, for the time being, our legislators have done their bit on what just happened to be the day after we celebrated World Suicide Prevention Day.  That's nice!

 

Access to Palliative Care Bill [HL]
To bolster the opposition to the Marris Bill, Baroness Finlay is spearheading the above Bill in the House of Lords.  It will, ‘Make provision for equitable access to palliative care services; for advancing education, training and research in palliative care; and for connected purposes.’  Its three-page details are here.  Its First Reading took place on 1 June and its Second Reading is scheduled for Friday 23 October.  Who could object to its admirable intentions?  We shall see.


The UK is number 1
In October, The 2015 Quality of Death Index was published by the Economist Intelligence Unit (EIU) – available to download here.  It ranked the quality of palliative care in 80 countries around the world.  The UK came first, with Australia and New Zealand taking second and third places.  It was no surprise that wealthy countries cluster at the top and many developing countries came near the bottom.  There were some shocks – Mongolia was 28th, Panama 31st and Uganda 35th.  Among the lowest rankings were countries such as China (71st), which is facing the dual difficulties of the slow adoption of palliative care and a rapidly ageing population.

And, as if to reinforce the EIU’s assessment of the UK, the Care Quality Commission (CQC) announced in mid-October that more than 90% of England's hospices were rated as ‘good’ or ‘outstanding’.  It is early days – so far only 37 hospice services have been inspected, out of a total of 324.  Of those so far assessed, 10 were judged ‘outstanding’, 24 ‘good’, two were deemed to be requiring improvement, and one was rated ‘’inadequate’.  Even so, the report highlighted several examples of poor symptom control, poor communication with patients and their families, as well as inadequate generalist and specialist out-of-hours services.  But the results were described as ‘encouraging’ by Andrea Sutcliffe, the CQC’s chief inspector of adult social care.

More needs to be done about end-of-life care, everywhere – there are huge variations in its provision and quality, even in the UK.  May the UK continue to lead the way forward – after all, we were the pioneers of the modern hospice and palliative care movement.

 

Martin’s case again rejected

In July, Lord Justice Elias and Mr Justice Collins, sitting in the High Court, London, rejected the case of the man known only as Martin or M.  The 50-year-old, who suffers from locked-in syndrome and is almost totally paralysed, argued that the guidance given to doctors by the General Medical Council (GMC) unreasonably stops him being given medical help to die.

 

The Court heard that in order for Martin to travel to a suicide ‘clinic’ abroad he needs to provide details of his medical history.  But doctors are unwilling to supply such documentation for fear of assisting in his suicide.  The GMC guidance says that when a patient raises the idea of assisted suicide, a doctor must listen and discuss, but cannot assist the person to die.  The judges ruled that this guidance is lawful because ‘aiding and abetting suicide’ is a crime in the UK, and they dismissed Martin’s case.  An appeal is expected.

 

The Nicklinson-Lamb case also again rejected

The latest episode of this long-running saga involving the deceased Tony Nicklinson, his wife Jane, as well as Paul Lamb, was enacted in mid-July.  The European Court of Human Rights in Strasbourg found that this combined legal challenge, based on Article 8 of the Convention, was 'manifestly ill-founded’ and declared it ‘inadmissible'.  In other words, the UK’s prohibition of assisted suicide, as detailed in the Suicide Act 1961, is not a violation of human rights.

 

The case of Tony Nicklinson has now been heard in the four highest courts available to UK citizens, and all four have pronounced similarly, namely, the decision to amend laws on assisted suicide belongs to national legislators.  Bluntly - it is for the UK Parliament to decide.  And it did so on Friday 11 September 2015.


 

USA and Elsewhere

 

California legalises assisted suicide

On Friday 11 September, the California Senate voted 23 to 14 to allow doctors to prescribe life-ending medication for some patients.  The bill needed final ratification by the Governor, Jerry Brown, who had previously given little indication of his intentions.


But on 5 October, California, the Golden State, the Land of Fruit and Nuts, became the fourth US state to legalise physician-assisted suicide (PAS) – alongside Oregon, Washington and Vermont.  This ended months of emotional and contentious debate over AB X2 15, also known as the End of Life Option Act.  The new law is expected to take effect by Spring 2016.  It is based on Oregon’s 1997 Death with Dignity Act and will permit doctors to provide lethal prescriptions to mentally-competent adults, who have been diagnosed with a terminal illness, and face the expectation that they will die within six months.
 

The California Governor and former Jesuit seminary student, Jerry Brown, who signed the new law into effect, issued an accompanying statement.  It read in part, ‘I have carefully read the thoughtful opposition materials presented by a number of doctors, religious leaders and those who champion disability rights.  I have considered the theological and religious perspectives that any deliberate shortening of one’s life is sinful.   I have also read the letters of those who support the bill, including heartfelt pleas from Brittany Maynard's family and Archbishop Desmond Tutu.  In addition, I have discussed the matter with a Catholic bishop, two of my own doctors and former classmates and friends who take varied, contradictory and nuanced positions.  In the end, I was left to reflect on what I would want in the face of my own death.  I do not know what I would do if I were dying in prolonged and excruciating pain.  I am certain, however, that it would be a comfort to be able to consider the options afforded by this bill.  And I wouldn’t deny that right to others.’


The reference to Brittany Maynard is significant.  This articulate, photogenic 29-year-old learned on New Year’s Day 2014 that she had brain cancer and a 6-month prognosis.  A little later, she decided to move from California to Oregon so that she could legally take medication to end her life, before her 30th birthday.  On Saturday 1 November 2014, Maynard did just that.  Her case undoubtedly brought the issue to the US consciousness.  She had become a nationally-recognized advocate for the assisted suicide lobby group Compassion & Choices (C & C), formerly known as the Hemlock Society, which seeks to expand 'aid-in-dying laws' beyond the current handful of states.  In October 2014, C & C had launched a slick video about Brittany on YouTube 
within a year it had been watched about 12 million times.  It resonated with the WWW the worried, well and white.

But as the spokesman for Californians Against Assisted Suicide, a coalition of disability rights, healthcare, civil rights and patient advocacy organisations, said, ‘This is a dark day for California and for the Brown legacy.’  He might have added, ‘and for the world.’  And here is the warning for us all – this 2015 bill was the 8th attempt by Californian assisted suicide activists.  Such deluded men and women are ideologically driven and persistently determined.  They and their message must be constantly resisted.

 

The Pain-Capable Unborn Child Protection Act

In May, the House of Representatives passed this bill, which would ban most abortions after 20 weeks nationwide, with a bipartisan 242 vs. 184 vote.  Then Senator Lindsey Graham introduced the bill into the Senate in June.

 

On 22 September, the bill received a majority of votes, 54 vs. 42, in the Republican-controlled Senate.  But it fell short of the required 60 votes to overcome a Democratic filibuster.

 

‘It is a big disappointment that our elected officials did not pass the overwhelmingly popular, common sense, late-term abortion ban today,’ said Jeanne Mancini, President of the March for Life Education and Defense Fund.  She pointed out the poignant irony that, ‘In the words of Pope Francis (who was visiting the nation’s capital that very week), “The level of progress in a society is measured by its capacity to safeguard life, above all in its most fragile stages.”  As a country we would flunk this progress test today.  America is called to defend life.  And our senators are elected to represent their people, not extremist views.'  She continued, 'The fight is not over.  Similar to the partial-birth abortion ban, this will take time.  But we will succeed.’

 

Abortions in Texas and Wisconsin and Ohio and …

Texas, like several other states, has over recent years passed pro-life abortion laws.  These have included such provisions as a 24-hour ‘cooling off' period, mandatory ultrasounds, admitting privileges to nearby hospitals for all abortionists as well as health and safety upgrades for their facilities.

 

Are these new laws working?  In August, the Texas Department of State Health Services (DSHS) reported that 63,849 abortions were performed in Texas during 2013.  This was 4,449 fewer than in 2012, and down from more than 77,000 in 2010. 

 

And similar decreases are being reported from other states.  For example, in Wisconsin, abortion is 10% down, in Ohio it is 8.7%, in Pennsylvania it is 7%, in Vermont it is 12% and in North Dakota it is 11% down on the previous year.  The causes of these reductions are disputed, but for many the pro-life laws are getting credit.  Whatever the true explanation, unborn lives are being spared.

 

Another winner against ObamaCare

The world’s largest privately-owned publisher of Christian books and Bibles has won its case for exemption from the US Government’s health insurance mandate, the controversial Affordable Care Act, also known as ObamaCare, with its insistence that employers must pay for abortifacient ‘contraceptives’, such as the morning-after pill, for their employees.

 

Lawyers for the Illinois-based Tyndale House Publishers argued that companies should be allowed to operate in line with their religious or moral convictions.  In July, a federal district court issued a permanent injunction in favour of Tyndale.  They can now do business according to the Book they publish!  It was back in July 2014 that Hobby Lobby, a Christian-run business won its pioneering case against the overbearing mandate in a landmark ruling by the United States Supreme Court.

 

The Polish government backtracks

Across the whole of Poland, schoolchildren are taught lessons within a pro-family subject known as WDZ, which translates as ‘Upbringing for Family Life’.  Its aim it to prepare young people for marriage and family life.  On 9 July, the Education Minister, Joanna Kluzik-Rostkowska, announced that the government wanted to introduce explicit sex education into the syllabus of the nation's schools.

 

A coalition of 26 pro-family groups came together to oppose the changes.  A protest rally in Warsaw attracted thousands of parents.  Before the rally took place, Kluzik-Rostkowska sought reconciliation by declaring that, ‘… work on changing the WDZ curriculum hasn’t started yet.’  But Polish parents have not been pacified and are under no illusion that their children remain at risk.  The vigilance and resistance continues.

 

Euthanasia propaganda for Dutch schools

On 3 September, the Hyperion Lyceum, a secondary school in Amsterdam, became the first ever to use a new educational kit developed by the Dutch ‘Voluntary End of Life Association’ (NVVE).

 

Far from being a neutral presentation, the kit unashamedly pleads for euthanasia and aims to make it acceptable among young people.  Many would call it a euthanasia propaganda tool.  Indeed the kit’s title is ‘Euthanasie Doodnormaal’, which translates as ‘Euthanasia: Dead-normal’.  To date, there has been no protest, official or unofficial, regarding the NVVE's action.  How different are the cultures of Holland and Poland.

 

Canadian euthanasia
In February 2016, Canada is set to drop its criminal prohibition against doctors who aid the terminally ill to die, following a ruling by the Supreme Court of Canada last year.  But, except for Québec, no Canadian province yet has a legal framework in place to regulate the practice.


Only Québec is now forging ahead.  Its professional body that regulates doctors, the Collège des médecins, has already published a how-to manual for doctors wanting to euthanise their patients, along with contents of a death kit to be issued to them by pharmacists.


 

Miscellaneous But Still Important

 

A new gene-editing technique – CRISPR-Cpf1

CRISPRs (clustered regularly interspaced short palindromic repeats) exist in bacteria as a kind of immune system that identifies and excises invading viral DNA.  Researchers have now adapted this protocol to edit genes and genomes virtually at will.  In essence, DNA can be cut out and spliced in, anywhere and everywhere, and easily, and cheaply.  In theory, genome editing could repair the mutations responsible for all heritable human diseases.  First there was CRISPR-Cas9.  Already the CRISPR-Cas9 technique is revolutionizing genetic research – scientists have used it to engineer crops, livestock and even edit the genomes of human embryos.  The latter was reported in the April issue of Protein & Cell by a team headed by Junjiu Huang at the Sun Yat-sen University in Guangzhou.  This key paper can be read here.

 

Then in September came the improved version, CRISPR-Cpf1.  In a paper published in Cell, Feng Zhang and his team at the Broad Institute in Cambridge, Massachusetts, reported the discovery of a protein called Cpf1 that may make CRISPR even simpler and more precise.

 

The scientists searched a range of bacteria and found two Cpf1 enzymes that were capable of cutting human DNA.  Whereas Cas9 requires two RNA molecules to cut DNA, Cpf1 needs only one.  Cpf1 also cuts DNA at different places and in a different way, making it more useful.  Cas9 cuts both strands of DNA at the same position, leaving behind what are known as ‘blunt’ ends.  Cpf1 leaves one strand longer than the other, creating a 'sticky' end, which is strategically more advantageous because it allows the insertion of DNA to be more controllable, more frequent and more efficient.  This field of research is hot – very hot – and no doubt more and better techniques will be discovered in the near future.  Radical gene editing has undoubtedly arrived.

 

Gene editing in pigs

A long-term dream of many medical scientists has been the use of pigs in which to grow human organs for transplantation – it is called xenotransplantation.  But rejection by the human immune system and infection by porcine endogenous retroviruses (PERVs) have been major stumbling blocks.


On 5 October, at a meeting of the US National Academy of Sciences, George Church of Harvard Medical School in Boston, Massachusetts, announced that his research team had used CRISPR-Cas9 to inactivate as many as 62 PERVs in pig embryos (published here).  In addition, the group modified more than 20 genes in pig embryos that encode for proteins known to trigger a human immune response or cause blood clotting.  This is preliminary work and the edited pig embryos have yet to be implanted into mother pigs.  When that is accomplished, the researchers hope they will produce suitable non-human organ donors.

 

Analogous, but far more bizarre, news come from the Beijing Genomics Institute, located in Shenzhen.  It has created so-called micropigs by gene editing a small breed of pig known as Bama.  The gene-editing technique they used employed TALENs (transcription activator-like effector nucleases) rather than CRISPRs to disable certain genes.  In September, the Institute announced that it would start selling these little piggies as pets.  They will cost about £1,000 and when mature, they will weigh about 15 kg, akin to a medium-sized dog.

 

The ethics and practice of gene editing

Like all new radical technologies, CRISPR creates ethical concerns.  Herein is the potential to modify all of nature, in particular human beings, beyond our imagination.  But if gene editing becomes acceptable for medical purposes, to cure human diseases, will it also be used for non-medical purposes, to introduce, enhance or eliminate human traits?

 

Many are concerned.  For example, on 12 March, in Nature, Edward Lanphier, chairman of the Alliance for Regenerative Medicine in Washington DC, and four co-authors called on scientists to agree not to modify human embryos – even for research purposes.


On 29 April, a week after the Huang et al. work was published, the US National Institutes of Health (NIH) reaffirmed its ban on federally-funded research that involves gene editing of human embryos.  In a statement the NIH director, Francis Collins, spelled out the agency’s long-standing policy against funding such research and the ethical and legal reasons for doing so.  The NIH is concerned about the safety of the technique as well as the ethical implications of altering genes that will be passed to future generations of humans by so-called germline gene therapy.  As Collins confirmed, ‘NIH will not fund any use of gene-editing technologies in human embryos.  The concept of altering the human germline in embryos for clinical purposes has been debated over many years.  Advances in technology have given us an elegant new way of carrying out genome editing, but the strong arguments against engaging in this activity remain.’

On 8 October, a UNESCO panel, the International Bioethics Committee (IBC), stated that, ‘Gene therapy could be a watershed in the history of medicine and genome editing is unquestionably one of the most promising undertakings of science for the sake of all humankind.’  But it also warned that, ‘… this development seems to require particular precautions and raises serious concerns, especially if the editing of the human genome should be applied to the germline and therefore introduce hereditary modifications, which could be transmitted to future generations.’  The IBC therefore called for a moratorium on this specific procedure.

Gene-editing advocates also exist and they have spoken.  For example, on 2 September, a coalition of five leading biomedical research UK funders, including the Wellcome Trust and the Medical Research Council, issued a joint statement, ‘… in support of the continued use of CRISPR-Cas9 and other genome-editing techniques in preclinical research.  This includes the use of the technology for research purposes in human reproductive cells and early embryos, where this is fully justified, scientifically and ethically, and within the confines of the law.’  And further, ‘We also recognise … that there may be future potential to apply genome editing in a clinical context using human germ cells or embryos, though this is prohibited.  This raises important ethical and regulatory questions, which need to be anticipated and explored in a timely and inclusive manner as the basic research proceeds and prior to any decisions about clinical application.’


On 10 September, the influential Hinxton Group, ‘a global network of stem-cell researchers, bioethicists and experts of policy and scientific publishing’, issued a 9-page forthright statement in favour.  It declared, ‘Research involving editing the human genome, including research with human embryos, is essential to gain basic understanding of biology and germ cells and should be permitted.’  The full statement can be read here.  While the Group makes a clear distinction between research and clinical application, everyone knows that such bioethical lines are easily blurred, simply crossed and readily forgotten.


Indeed, the momentum for trying human gene editing is already evident.  For example, on 18 September, researchers, led by Kathy Niakan from by the London consortium of the Francis Crick Institute, applied to the HFEA for a licence to genetically modify human embryos by CRISPR-Cas9 in order to further understand the genetic causes of miscarriage during pregnancy.  Editing the genomes of human embryos for a therapeutic use, for instance, to eradicate a genetic disease, is illegal in the United Kingdom, but research work is permissible, with a licence.  Of course, the human embryos used would be ‘small', surplus to requirements, donated, destroyed before 14 days and never used for reproductive purposes.  Of course!

 

But licenced by the HFEA?  Oh no!  That incompetent regulatory body that from 1990 has sanctioned the ill-famed and arbitrary 14-day rule, and approved every application for destructive human embryo research, and in 2008 endorsed the creation of the now out-moded ‘human admixed embryos’, and in 2015 authorised the use of mitochondrial DNA replacement techniques, aka, ‘three-parent’ IVF.  Now the HFEA is broadening its remit to include human gene editing.  Will it say ‘No’?  I shall eat yet another of my hats if it does!

 

What is required is public debate, wide and serious, about these new technologies and the imminent prospects for genome engineering, not least in terms of human medicine, ‘designer babies’ and beyond.  There have already been calls from US scientists for a temporary pause to this sort of work.  Such a moratorium would engender both thoughtful caution and public engagement.  The risk of harming future generations is far too serious to ignore.  There is already wild talk about where the first CRISPR baby will be born Japan, India or China?  In December, members of a group of academic societies from America, Britain and China are hosting a meeting in Washington DC to thrash out some of these fundamental issues.  I hope they are prudent.


Top  ▲▲                                      Home