Update on Life Issues – February 2010
 

The Next Ten Years of Bioethical Issues
At the turn of every decade, it is customary for the enterprising (and perhaps the foolhardy) to predict events and trends for the next ten years – in this case, a sort of 20:20 vision.  So here goes for bioethical issues.

First, a little history.  The nineteenth century can be regarded as the century of chemistry. Correspondingly, the twentieth century was dominated by physics.  And now, the twenty-first is predicted to become known as ‘the century of biology’.  It certainly opened with an auspicious bang.  In June 2000, Bill Clinton and Tony Blair hosted a White House press conference to herald the completion of the first draft of the human genome – the sequencing of the 3 billion chemical ‘letters’ of our DNA.  They called it, ‘the most wondrous map ever produced by human kind.’  Others saw it as a scientific landmark comparable with the invention of the wheel, or the splitting of the atom.

Expectations were high.  We were told that human medicine was about to be transformed by this new genetic knowledge.  To date, this has not really happened – the initial bang has become more of a sustained whimper.  In all the excitement we forgot that it typically takes two or more decades for novel medical technologies to reach patients.  As a consequence, the promised age of personalized medicine has been delayed, but, make no mistake, it will be coming.  And one signal of this future is that the cost and speed of DNA sequencing is falling rapidly – the $1000 personal genome analysis will soon be such a smart birthday present.  Already the entire genetic codes of skin and lung cancers have been reported and these advances could revolutionise the detection and treatment of these diseases. Work is in progress on breast, liver, mouth, stomach, ovarian and pancreatic cancers.  Even so, formidable barriers still exist.  For example, each genome sequence will need to be interpreted skilfully to assess a person’s predisposition to a particular disease.  Moreover, most diseases are caused by largely unknown interactions of dozens or hundreds of genes, plus as yet unidentified environmental factors.  Only when these complexities are better understood will we be prescribed personalized, tailor-made, therapeutic drugs, and perhaps even learn what disease we will die from – it will be so informative!  Only then will pharmacogenomics have truly arrived.  Lagging behind will be our knowledge of psychiatric disorders, such as schizophrenia, but they too will eventually be ripe for this genetic revolution.

One bioethical issue that already exists is abortion and it will still be here in 2020.  However, the annual figures for England and Wales may remain similar to the current 200,000 totals.  One reason for this statistical status quo will be the greater availability of chemical abortifacients, like Levonelle One Step, the currently-available, over-the-counter (OTC), morning-after pill (MAP), based on levonorgestrel.  This has recently been joined by another type of MAP, known as EllaOne, based on ulipristal acetate.  Whereas the former is advertised as effective for three days after unprotected sexual intercourse, the latter is apparently effective for up to five days.  What a medical advance!  Yet, up to five days, means that fertilization is more likely to have occurred so this new MAP will be halting the implantation of embryos even more often.  At present, EllaOne is available only on prescription, but that will soon and simply be amended to OTC and online.  Early abortions caused by these MAPs are not recorded in government figures, hence the likelihood of the 200,000 published figure remaining static.  Abortion has always been popular with proponents of population control.  Their ranks have recently been swollen by the eco-pessimists.  Already the UK’s Optimum Population Trust is urging us to offset our carbon footprint by funding contraception programmes – cutting the number of babies born, by physical, chemical or surgical methods, are the favourite tools of such groups.  Some are now even praising the barbaric, abortion-based, one-child policy of China as a model appropriate for the whole world.

Teenage conceptions will be in decline by 2020.  Not because the previous decade’s government curriculum, built on pills, condoms and explicit sex education, proved to be successful.  Its failure will, at last, be grudgingly admitted.  Instead, there could be a sophisticated, and perhaps compulsory, programme of hormonal control for pubescent boys and girls.  Such a scheme already exists for some ‘recalcitrant girls’ in the form of implanting them with long-acting reversible contraceptives (LARCs).  In other words, our children will be rendered infertile until the newly-established, though as yet imaginary, Teens and Twenties Pregnancy Advisory Team (TATPAT) gives its approval for selected couples to come off the treatment and reproduce.  Note that recreational sexual intercourse among teenagers will continue unabated, indeed it will be even more rampant, because there will be a minimal risk of pregnancy – but LARCs give no protection against sexually-transmitted infections (STIs), so their numbers will continue to soar.

Another bioethical battle currently visible on the horizon is this – will those who have a conscientious objection to certain medical procedures still be allowed to opt out?  For example, will healthcare professionals, including students and nurses, be compelled to assist in abortions and assisted suicides, and will pharmacists be forced to fill prescriptions for morning-after pills?  Or, will many Christians, along with the ‘morally sensitive’, be squeezed out of careers in particular avenues of healthcare?  The practice of medicine will become incalculably worse without them.

Attempts to introduce presumed consent for organ donation will founder.  Most people do not want to be coerced by government, especially when it involves themselves so intimately.  Furthermore, many will remain too scared to discuss the issues with transplant coordinators, especially since the definition and diagnosis of death have yet to be settled.  Transplants, from either living or dead donors, will be substantially replaced by more reliable mechanical devices, by xenotransplants from animals, or by organs grown from patients’ own stem cells.  The world's first successful transplant of a windpipe, grown using stem cells taken from Claudia Castillo in Barcelona in 2008, was just the start.  This is all part of the regenerative medicine revolution, the dream of replacing aged, diseased and injured cells or body parts with new ones.  Stem cell technology will be everywhere.  But it will be the adult variety that is in vogue – treatments with embryonic stem cells will be history.  A few human trials of the latter will have proved to be too complex, unsafe and inconclusive, somewhat redolent of the failed gene therapies of the previous decade.  And all that hope (and hype) of cures from those horrid admixed human embryos (animal-human hybrids) will be long-forgotten.  Instead, induced pluripotent stem (iPS) cells will be the flavour of the decade – their methods of production will become even simpler, safer and cheaper.  And who could doubt that another giant leap forward in this field of biology, as the first production of human iPS cells was just three years ago, will not occur?  Watch out for serious cell reprogramming.

Assisted reproductive technologies (ARTs) will also turn out to be de rigueur.  Previously ARTs were for the few, before long, they will be for the many.  Reproductive sexual intercourse will become so twentieth century!  Think of the control, the convenience and the cost-effectiveness of large-scale ARTs.  The control will allow governments and employers to manage breeding and thereby optimise productivity at work and thus attain and maintain fiscal stability, even prosperity, for the nation.  Think ARTs – it’s a citizen’s duty!  The convenience will come from the coordination of ARTs treatment cycles, clinicians’ time and hospital facilities.  Think ARTs – they’re resource efficient!  And cost-effectiveness will be implemented not only by using more and more professional surrogate mothers (a UK woman is currently on her eighth such pregnancy!), but also by implementing ever-more sophisticated screening techniques for pre-implantation genetic diagnosis (PGD), such as comparative genomic hybridization (CGH), for an ever-increasing clientele.  The Human Fertilisation and Embryology Authority (HFEA) has recently published a list of 116 inherited conditions many of which are not life-threatening and are readily treatable by current medical procedures that fertility clinics can now screen for and then destroy affected embryos without requiring special permission.  In addition, home genetic testing will become popular.  For example, the Counsyl test is about to be launched in Britain.  It is a simple saliva test, costing about £700, which will detect if either of a couple are carriers of up to 109 genetic mutations that could affect prospective children.  No medical supervision and heightened needless fears leading to increased embryo screening and more abortion.  Never mind.  Think ART – forget disability!  The upshot will be healthy babies of the right sex, with the characteristics we want, when we want them.  How smart is that?  And there will be fewer strings attached because State surrogates and crèches will do more of the hard work of child bearing and rearing for us.  Then we will be much freer to pursue our careers and pastimes.  Ah, that modern goal of more ‘me-time’.  Maybe.

At last the elderly will be seen as THE huge bioethical problem of the twenty-first century.  Even in 2010, the over-80s are the nation’s fastest growing age group.  It will soon be obvious that their medical and care needs will become excruciatingly costly.  And then the legalisation of voluntary euthanasia will be regarded as essential.  The signs are all around us.  Trendsetting celebrities, like Martin Amis and Terry Pratchett, have grabbed media headlines by coming out in favour of assisted suicide.  The Scottish Parliament has recently been presented with a bill to legalise it.  Investigations and prosecutions of those accused of assisting suicides, including that of the high-profile case of Kay Gilderdale, have resulted in perplexing outcomes.  Of course, such a public policy will still be unpopular among some, especially those religious folk.  But consider the benefits – the high costs, the demands of caring and those guilty consciences will all be dealt with so neatly.  After that, the discussion will move on to non-voluntary euthanasia.  And why not?  Why not help those poor old folk by making those difficult decisions for them – after all, isn’t that what true compassion is all about?

Finally, many of the bioethical events and trends of the next ten years can be summed up in one word – eugenics.  It will be firmly back on the agenda, driven, as ever, by elitism/racism and reproduction/population.  Social stability is such a delicate balance of bioethics.  Take for instance, life expectancy and fertility levels.  Good medicine has brought about an increased life expectancy and created unprecedented numbers of old-age pensioners, yet to pay for their pensions we need large numbers of young people working and paying taxes.  But too many young workers will only exacerbate this ‘pensioner problem’, three or so decades on.  What we need – just like those eugenicists of old told us – is the appliance of science.  This nation needs a controlled number of healthy offspring, who can work and pay their way.  What we do not need are the unfit, whether young or old, who are both unproductive and costly.  Hence, we need robust public policies of ARTs, abortion and euthanasia. In other words, we need control of human life at every stage – in vitro, in utero and in senio (old age, dotage).

And the great alternative?  Let us trust that much of the above is cynical and overly-pessimistic.  Is there not just a glimmer of hope that knowledge and compassion will nudge our brains and hearts to the truth surrounding some of these awful predictions?  Could the coming decade of austerity bring us to our senses, causing us to focus on the issues that really matter, such as life, family and relationships?  What huge Christian duties and responsibilities are ours – we should be in the vanguard, leading the way.  If Christians cannot demonstrate a better way to live, then shame on us. These are not optional extras of Christian living.  They are our duty.  The Lord Jesus Christ declared, "So you also, when you have done everything you were told to do, should say, ‘We were unworthy servants; we have only done our duty.’" [Luke 17:10].
 

The Manhattan Declaration
The USA is changing.
 While many initially welcomed the new Obama administration, the honeymoon is over and now many have become alarmed at the President’s direction towards liberal extremism.  This has provoked a formal response from many of America’s religious leaders.  It is called the Manhattan Declaration (it was drafted in New York).  Some have summarized it as, ‘God’s Law tops Obama’s law.’

The Declaration was launched on 20 November 2009 at the National Press Club in Washington DC by an impressive collection of evangelical Christian leaders, Roman Catholic bishops and other conservatives.  Already well over 400,000 people have signed it.  The full document can be read at www.manhattandeclaration.org  It claims for itself, ‘The 4,700-word declaration issues a clarion call to Christians to adhere to their convictions and informs civil authorities that the signers will not – under any circumstance – abandon their Christian consciences.’

The preface (with American spelling retained) outlines the gist of the Declaration:

‘Christians, when they have lived up to the highest ideals of their faith, have defended the weak and vulnerable and worked tirelessly to protect and strengthen vital institutions of civil society, beginning with the family.

We are Orthodox, Catholic, and evangelical Christians who have united at this hour to reaffirm fundamental truths about justice and the common good, and to call upon our fellow citizens, believers and non-believers alike, to join us in defending them.  These truths are:

1. the sanctity of human life.
2. the dignity of marriage as the conjugal union of husband and wife.
3. the rights of conscience and religious liberty.

Inasmuch as these truths are foundational to human dignity and the well-being of society, they are inviolable and non-negotiable.  Because they are increasingly under assault from powerful forces in our culture, we are compelled today to speak out forcefully in their defense, and to commit ourselves to honoring them fully no matter what pressures are brought upon us and our institutions to abandon or compromise them.  We make this commitment not as partisans of any political group but as followers of Jesus Christ, the crucified and risen Lord, who is the Way, the Truth, and the Life.’

And the final paragraph states:

‘Because we honor justice and the common good, we will not comply with any edict that purports to compel our institutions to participate in abortions, embryo-destructive research, assisted suicide and euthanasia, or any other anti-life act; nor will we bend to any rule purporting to force us to bless immoral sexual partnerships, treat them as marriages or the equivalent, or refrain from proclaiming the truth, as we know it, about morality and immorality and marriage and the family.  We will fully and ungrudgingly render to Caesar what is Caesar’s. But under no circumstances will we render to Caesar what is God’s.’

Strong words indeed.  And among the evangelicals backing the Declaration are Chuck Colson, James Dobson, Ligon Duncan, Tim Keller, Joni Eareckson Tada, Josh McDowell, Wayne Grudem and Al Mohler.  Perhaps predictably, other notable evangelicals have refused to sign.  They include John MacArthur, R C Sproul and Alistair Begg.  While these latter men wholeheartedly oppose the bioethical decline of America, their reservations about the Declaration have a strong theological resonance.  They refuse to sign principally because nowhere in the Declaration is ‘the Gospel’ defined.  The Protestant understanding of the Gospel is different otherwise it is as if the Reformation never occurred.  The doctrines of authentic, historic, orthodox, biblical Christianity do matter.  There is not a common faith among the Declaration’s signatories.

On the other hand, co-belligerency is an acceptable, even necessary, activity.  Joining hands with others, whether in opposition to abortion or a local strip club, is rational and reasonable.  Even Spoul, one of the non-signers, has stated, ‘I would march with the bishop of Rome and an Orthodox prelate to resist the slaughter of innocents in the womb.’  Sadly, it seems that those who drafted the Declaration have gone too far, unnecessarily too far.  And they have spoiled it.  There was no need to blur the distinctives of the various faith communities.  As a manifesto against abortion, euthanasia, human cloning, same sex marriage, destructive human embryo research, and the assault on freedom of speech and religion, the Declaration is wholesome and commendable.  As a theological document it is too liberal and too inclusive.

Getting evangelicals onside and cooperating is a complex and intricate affair – we all know that.  It is a pity, but it is also a reality.  And movements, like the Manhattan Declaration, which were intended to demonstrate unity, can so easily achieve divergence.  Practical co-belligerency is one thing, theological ecumenism is quite another.

Now here is the question: would you sign the Manhattan Declaration?  I know what I would do, but what about you?
 

Euthanasia and Assisted Suicide
In October 2009, the author, broadcaster and campaigner, Sir Ludovic Kennedy died, aged 89. He generally appeared to be a decent and agreeable old man.  But as a spokeswoman for Dignity in Dying, of which he was a former president, confirmed, ‘He was a passionate advocate of assisted dying for terminally-ill people, whose compassion and vigorous intellect were an asset to the organisation.’  Beware, even the nicest of people can have warped ideas.

Meanwhile, some in the Netherlands are having second thoughts.  It is claimed that legalized euthanasia has led to a severe decline in the quality of care for Dutch terminally-ill patients.  This surprising assertion is made by Dr Els Borst in an interview for a recent book entitled, ‘Verlossers naast God’ (Redeemer under God).  Dr Borst was the former Health Minister and Deputy Prime Minister who guided the controversial euthanasia law through the Dutch parliament and finally into law in 2001.  She now regrets the haste with which she pushed through the legislation and believes that the policy was a mistake brought in 'far too early'.  In hindsight, she wishes they had first focused on palliative care.  It has long been known that palliative care in Holland is rudimentary – for example, in Amsterdam, with a population of 1.2 million, there are currently only two small hospices.  It is said that some Dutch patients ask for euthanasia out of fear of dying in agony because proper care and adequate pain relief are so often not accessible.

We are not alone – Canada has a similar problem.  The Royal Society of Canada has recently appointed a panel of so-called experts, ‘to assess the pros and cons of permitting physician-assisted death.’  Four of the six panel members, including the chairman, Dr Udo Schuklenk, are well-known supporters of the legalization of euthanasia and assisted suicide.  It will not be difficult to predict that panel’s conclusions.  It is reminiscent of our own quango, the HFEA, with its unsurprising bioethical direction and decision making, stacked as it is with IVF champions and embryo experimenters.

Back in the UK, we await the outcome of the public consultation on the Interim Policy for Prosecutors in Respect of Cases of Assisted Suicide.  The consultation closed on 16 December 2009 and the results are expected in the Spring.  Will the law be changed?  Proponents of euthanasia have certainly been vocal, tactical and well-funded.

Added in March 2010 - New Guidelines on Assisted Suicide Prosecutions
On Thursday 25 February, the Director of Public Prosecutions (DPP), Keir Starmer, published his ‘Policy for Prosecutors in Respect of Cases of Encouraging or Assisting Suicide’.  It replaces the interim guidelines issued in September 2009, which were the basis for a public consultation – almost 5,000 submissions were received.  The new guidelines can be read in full at http://www.cps.gov.uk/publications/prosecution/assisted_suicide_policy.html

Overall, they are better than feared.  Assisted suicide remains illegal.  The case of Debbie Purdy, which forced the DPP to produce guidelines, has not changed the law.  All cases of suspected assisted suicide will still be investigated.  No one will be guaranteed immunity from prosecution.  As Keir Starmer stated, ‘The policy does not change the law on assisted suicide.  It does not open the door for euthanasia.  It does not override the will of Parliament.’

The new guidelines list 16 ‘public interest factors’ to be used in favour of bringing a prosecution and just 6 such factors (reduced from 13 in the interim policy) against such a move.  Included in the former, is a new factor 14, ‘the suspect was acting in his or her capacity as a medical doctor, nurse, other healthcare professional … and the victim was in his or her care.’  In other words, there will be no encouragement of doctor-assisted suicide.

Another positive change is the deletion of any reference as to whether the victim had ‘a terminal illness or a severe and incurable physical disability or a severe degenerative physical condition.’  The interim guidelines had singled out those who were disabled or ill with the implicit intention that they would be afforded less protection than other people.

The interim guidelines tended to focus on the condition of the victim, whereas these new guidelines concentrate on the motives of the suspect.  As a result, a prosecution would be less likely if, as the new factor 2 states, ‘the suspect was wholly motivated by compassion.’  However, this will prove to be a stumbling block.  How can it be determined, especially when the only reliable witness is now dead?  Furthermore, it would be naïve to suppose that every spouse or close family member would always act with compassion.

Words on paper are one thing – practical implementation is another.  These guidelines must now be applied, never permissively and always safeguarding the vulnerable – good laws protect people.  We shall see.

Even so, there is one insuperable problem with issuing guidelines like these.  They tell people in advance that, if certain conditions are met, they are unlikely to be prosecuted.  This conveys a subtle message, namely, that assisting suicide can be acceptable, you can get away with it.  That is a move in the wrong direction.

Finally, it must be recorded that the DPP did listen and reacted positively to the many responses made by ‘pro-life’ people during the consultation period.  For that, we are thankful.  But, of course, this is not the end of the matter.  Euthanasia, in all its ugly forms, will remain a touchstone for end-of-life issues.  The battle goes on.

 

Assisted Reproductive Technologies (ARTs)
Belgian researchers have reported that pre-implantation genetic diagnosis (PGD) is safe for the children of singleton pregnancies.  They studied 581 IVF children, who had been screened by the PGD procedure, and they found that rates of birth defects and deaths were similar to those of children conceived by IVF but without PGD.  However – and it is a big ‘however’ – when multiple pregnancies occurred following IVF and PGD, significantly more deaths were recorded – 11.7 per cent of babies, were either stillborn or died within seven days, compared with 2.5 per cent of those not PGD-screened.  The causes of these differences were not explained.  Nevertheless, because PGD involves the extraction of a cell or two from the delicate early embryo, the possibility of physically damaging the remaining embryo must be considerable.  And this procedural damage is somehow more apparent in multiple pregnancies.

The IVF procedure itself also appears to have another newly-discovered downside.  The DNA of IVF babies is different from that of other children.  And that could explain their greater risks of low birth weights and defects as well as late-onset diseases, like diabetes.  The differences are not in their genes, but in their gene controllers or what are called, epigenetic switches.  According to the research leader, Carmen Sapienza of Temple University, Philadelphia, it is the levels of methylation of the DNA which differ and these could cause some genes to switch on or off at the wrong times in the IVF embryo or fetus.

Wherever ARTs take place, problems are never far away.  Here is one sad story.  Mary Roche and her husband, Thomas, had one child born in 1997.  In 2001, they started IVF treatment at the SIMS Fertility Clinic in Rathgar, Dublin.  Six embryos were produced – three were transferred to Mrs Roche, resulting in the birth of another child.  The other three embryos were frozen, but the couple subsequently separated.  Could Mrs Roche use them, even though her estranged husband refused his consent?  The High Court said, ‘No.’  She appealed that decision.  Now the Supreme Court of the Republic of Ireland has also ruled that she may not.  Moreover, it decreed that a frozen embryo created by IVF is not an ‘unborn’ person, entitled to enjoy protection under Article 40.3.3 of the Irish Constitution.  In 1983, this so-called Eighth Amendment asserted, ‘The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right.’  The five judges ruled that ‘unborn’ refers to a child in the womb, not in the clinic.  While the Court failed to define the embryo’s precise status, it urged the Oireachtas, yet again, to legislate on these issues.

The latest IVF clinic success rates for the UK were released in October 2009.  Alan Doran, chief executive of the Human Fertilisation and Embryology Authority (HFEA) said, ‘It is almost impossible to distinguish between them.’  That is odd because we all know some clinics are vastly more ‘successful’ than others.  The HFEA is pulling the wool over our eyes (again).  And they are certainly not doing a service to those who may wish to use IVF and pick out the star performers.  Here is the statistical twist. The new-style success rates are based on ‘the number of live births per embryo transferred’.  That looks sensible.  But to the HFEA ‘live birth’ means ‘live birth event’.  Thus a ‘live birth’ could be a singleton, twins or even triplets.  And does that skew ‘success rates’!  For example, if clinic A treats ten women and they all have one embryo transferred and they all produce one baby each, the clinic would have a 100 per cent ‘success rate’.  However, if clinic B also treats ten women and they all have two embryos transferred and they all produce twins, there would be twice as many babies, but the clinic's ‘success rate’ would be just 50 per cent – 10 ‘birth events’ divided by the 20 transferred embryos.  Professor David Spiegelhalter, a statistician at Cambridge University, says, ‘It's clearly an indicator chosen to have an impact.  If you are trying to persuade clinics not to put in multiple embryos, this measure of 'success' will change behaviour.’  It seems as though the HFEA is using statistical stealth to persuade IVF clinics to adopt its favoured policy of transferring only one embryo per treatment cycle.  But the HFEA is also confusing the general public (again).

Getting pregnant can be problematic for some 1 in 6 couples.  Minor, but significant, causes of infertility can be factors such as stress, sexually-transmitted infections and substance abuse.  Now a US study has shown that couples decrease their likelihood of conceiving by IVF if they share a bottle of wine a week.  That intake of alcohol – equivalent to six units each – can cut their chances of a live birth by a quarter.  Because ova and sperm take at least three months to develop, you should know pre-conceptual preparedness makes sense.

Everybody likes a buy-one-get-one-free offer.  Now an American company, The World Egg Bank, has signed a deal with IVI fertility clinics in Spain to provide US consumers with IVF vacations to Spain.  The package includes a 5-day round trip to Spain and costs $19,500 (£12,000), the same or less than the price of IVF in the US, but with the added bonus of a vacation in sunny Alicante.

The US Department of Health and Human Services (HHS) has recently awarded grants of $2.18 million to launch a public awareness campaign about embryo donation and adoption.  The organizations receiving this funding include the Baptist Health Foundation, Nightlight Christian Adoptions, the National Embryo Donation Center (NEDC) and Bethany Christian Services.  It is an attempt to deal with the inevitable ‘spare embryos’ generated by IVF procedures.  After a woman completes her IVF treatment she can donate her unused, ‘spares’.  These can then be adopted by another woman, who also undergoes IVF and raises any children produced as if they were her own.  It is a second-rate answer to a third-rate problem. Of course, it perpetuates IVF with all its inherent bioethical problems, but it must be better than destructively experimenting on, or merely squashing these ‘spare embryos’.

As with so many bioethical issues, prevention is easier, and better, than cure.  Would the world be a better place if ARTs had never been legalized?  One hundred scientists in Poland think so.  They have delivered a document urging their government to instigate a statutory ban on all artificial fertilization procedures.  In addition, the signatories have called on the government to fund, in full, treatment for the infertile by NaProTechnology, the ethical alternative to ARTs.
 

Human Stem Cell Clinical Trials
The stem cell battle is hotting up.  Which are best?  Adult or embryonic stem cells?  So far the ethics, science, profits and hope have sided with adult stem cells over embryonic.  Within the next couple of years, we may know which is really best because human clinical trials with the latter are about to commence.  Already trials using adult stem cells have provided therapies for over seventy different medical conditions including some cancers, juvenile diabetes, multiple sclerosis, heart damage, Parkinson's, sickle cell anaemia and spinal-cord injuries.  The use of embryonic stem cells has been cautious because of their uncertain stability and association with causing cancers.  But as Robert Lanza, one of the key embryo researchers in the US, has declared, ‘It has been over a decade since human embryonic stem cells were first discovered.  The field desperately needs a big clinical success.’  The race to be first in the world with that potential prize is definitely on.

A Maryland biotechnology company, NeuralStem, has already gained permission from the US Food and Drug Administration (FDA) to test its spinal-cord stem cells in twelve patients with amyotrophic lateral sclerosis.  A similar trial of patients with sub-acute thoracic spinal-cord injuries is also about to start using a product from the Californian biotechnology company, Geron.  Both trials have been previously delayed by the FDA because of safety fears.  Both trials involve placing cells into the spinal cord – NeuralStem’s product is made of cultured neural stem cells derived from a single eight-week-old fetus, whereas Geron’s product is derived from embryonic stem cells.

Advanced Cell Technology (ACT) in Worcester, Massachusetts has recently filed an application with the FDA to treat a rare form of progressive damage to the retina of the eye, known as Stargardt's macular degeneration, a form of incurable blindness.  The stem cells are embryonic and derived from IVF ‘spares’.  When suitably treated these stem cells can be transformed into fully mature retinal pigment epithelium cells.  Twelve human volunteers will receive transplants of these cells plus mild immuno-suppressant drugs to prevent any tissue rejection.

Back in the UK, a similar proposal to treat age-related macular degeneration with embryonic stem cells is being developed by a team led by Professor Pete Coffey of University College London.  However, because of its complexity and novelty, it is unlikely to start until early 2011.  Nevertheless, researchers at the University of Glasgow have already been granted the go-ahead for a clinical trial to assess the use of embryonic stem-cell transplants for stroke victims.  The cells, developed by the UK biotechnology firm, ReNeuron, were originally isolated from a human fetus.  Later this year, twelve people will take part in this preliminary safety study.

Nonetheless, treatments with adult stem cells are still proving to be extraordinarily successful.  For example, researchers in Portugal and at Wayne State University have employed them to treat spinal-cord injury patients, none of whom had use of their legs prior to treatment.  The results are encouraging.  Of the twenty patients treated, thirteen showed significant improvements, like being able to walk with the aid of braces or a frame, or recovering sensation and movement in their limbs.

The sheer simplicity of such treatments and the lack of rejection with adult stem cells remain remarkable.  Take the case of Russell Turnbull, who became partially blind in his right eye when he was sprayed with ammonia while trying to break up a fight in 1994.  He has since suffered with cloudy vision, pain at every blink and extreme sensitivity to light.  He is one of eight patients with limbal stem cell deficiency (LSCD), who were treated in a recent trial at the North East England Stem Cell Institute in Newcastle.  All now have improved vision.  And the treatment is so deceptively straightforward.  Limbal stem cells are taken from the patient’s good eye (in the case of Mr Turnbull, his left eye), grown in the laboratory and then used to replace the damaged corneal tissue.  The outcome – improved eyesight, pain relief, no immunosuppressant drugs, no tissue rejection.  The hope is to extend this type of treatment to provide a total cure for LSCD and thereby replace the traditional regimes of mere symptom relief by long-term multiple medication.

Meanwhile, the amazing iPS (induced pluripotent stem) cell story, barely three years old, is progressing, by leaps and bounds.  Their production is getting easier, cheaper, faster and more efficient.  For instance, researchers at the Scripps Research Institute in La Jolla, California have reported that the addition of two simple compounds, instead of the potentially-dangerous viruses used in previous reprogramming procedures, improved reprogramming efficiency of these cells by a 100-fold.  Then they discovered that when another small molecule, thiazovivin, was added, the yield of iPS cells was boosted 200-fold and the process took just two weeks rather than the previously-required four.

The first commercial iPS cell product was launched at the end of 2009 by Cellular Dynamics International in Madison.  The product, iCell Cardiomyocytes, is produced from small volumes of human blood and these cells apparently, 'spontaneously beat in vitro and exhibit the electrophysiological and biochemical properties of normal human heart cells.'  Nevertheless, these cells are not intended for direct use in humans, rather they are to aid drug discovery and safety screening within the pharmaceutical industry.

Surely none can doubt that iPS cells are here to stay and that they will play a big part in future medical advances and treatments.
 

Teenage Sex and Pregnancy
The sixth annual Report of the Teenage Pregnancy Independent Advisory Group (TPIAG) makes for dire reading – I almost wept when I read it.  The TPIAG is the body that monitors the Government’s Teenage Pregnancy Strategy, set up in 1999, with its key objective of halving the number of under-18 conceptions by 2010.  Its time is nearly up.  The Report records that, ‘Since the Strategy began there has been a national reduction in the under-18 conception rate of 11%.’  Furthermore, it states that, ‘The Teenage Pregnancy Strategy is excellent and works very effectively when it is implemented properly.’  It is hard to believe that, after all these years, a decrease of just 11% nationally (or at best 26% in some local areas) can ever be described as either ‘excellent’ or ‘effective’.

The Strategy is based on the expectation that teenagers will have sexual intercourse.  It responds to this (false) assumption, by relying on the promotion of explicit sex education, free pills (contraceptive and morning-after) and condoms.  In other words, it equips our children with everything they need to start a disastrous life of multiple relationships, unplanned pregnancies and sexually-transmitted infections.  There is virtually nothing in the Strategy about delay, respect, or, least of all, abstinence.  The Government sneers at abstinence, yet, in theory, it must work.  Surely, by now, it is time to conduct a proper trial of abstinence in the UK – does it work, or does it not?

Instead the Government tinkers.  Take two recent examples.  First, it has backed a pilot scheme called, ‘Contraception: Worth Talking About’, in the hope of cutting conception rates in two London boroughs Southwark and Lambeth by giving free contraceptive pills to women (and girls under 16), without a doctor’s prescription.  That could be medically dangerous as well as hazardously enticing to the curious.  Second, it has launched yet another new initiative – to encourage young people to talk more openly about sex and contraception.  The Department of Health believes that a lack of knowledge and communication, as well as misinformation and poor attitudes, are hindering safer sex in young people.  A spokesperson for the Department was apparently aghast that 92% of people interviewed could not name the 15 types of contraception options available to them.  This is asinine.

The achievements of the Teenage Pregnancy Strategy have been a miserable return for an investment of some £300m.  But a far greater loss has been incurred by our children – they have been sexualised and abandoned by this Strategy.  Nearly ten years of pills, condoms and value-free sex education have failed them, big time. It will take them, and us, years to recover.

Recreational teenage sex is not good.  It is not good physiologically, developmentally, psychologically, bioethically or medically.  Verification of this proposition continues to accumulate.  For example, new research conducted with 20,000 women by the International Agency for Research on Cancer concluded that having sex at an early age can double the risk of developing cervical cancer.  It has long been known that higher rates of cervical cancer exist among poor women.  It was thought that these were related to a decreased uptake of screening or their higher human papillomavirus (HPV) levels.  The cause is now believed to be simply early sex.  Apparently poorer women have a higher risk of the disease because they tend to have sex about four years earlier than more affluent women.

And finally, what does the TPIAG recommend in its penultimate Report?  It makes seven recommendations.  In essence it wants more of the same – more money, more workers, more provision of contraceptive methods and more advice on sexual health, including sex education for five year olds.  This is never going to halve the conception rate.  It is a counsel of despair.  It needs challenging.  It needs changing.
 

General Election 2010
Some time before June, there will be a general election.  Men and women will be knocking on your door to ask for your vote.  In return, ask them something.  For example, what are their views on euthanasia and abortion and teenage sex education and embryo experimentation and …?  You get the idea?

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