Update on Life Issues - October 2009

Lisa Jardine and the HFEA
On 1 October, the new Human Fertilisation and Embryology Act 2008 (HFE Act 2008) came into force.  It is the single greatest change to affect the UK fertility and embryo research sectors since the Human Fertilisation and Embryology Authority (HFEA) was established nearly two decades ago.

The HFEA’s first chairman, back in 1990, was Professor Colin Campbell, followed in 1994 by Baroness Ruth Deech and in 2002 by Dame Suzi Leather, plus a couple of short-lived heads.  Now, since April 2008, Lisa Jardine has been in charge.  Professor Lisa Jardine CBE is also the Director of the Centre for Editing Lives and Letters and Centenary Professor of Renaissance Studies at Queen Mary, University of London.

So, is she bioethically liberal or conservative, will her rule be stringent or compliant?  Has she already stamped her imprint on this disorderly organisation?  Perhaps, not yet, but some of her recent statements are worrying, even alarming.

For example, she has recently called for a public debate to decide whether people who donate ova and sperm to infertile couples should be paid more than the current maximum of £250 for ‘reasonable expenses’.  The thought of buying and selling, trading in human gametes leaves a nasty taste in one’s mouth.  Will there be a standard price, or a premium for gametes from beautiful or intelligent people, or a discount for multiple purchases?  The donation of bodily tissues, such as blood and organs, has traditionally been regarded in the UK as willingly-given, altruistic gifts.  Payment would change everything, including coercion.  Why the need anyway?  The latest figures from the HFEA show that numbers of sperm and ova donors have steadily increased after a lull around 2005 when donor anonymity was removed.  In fact there were 284 sperm donors and 1084 ova donors during 2008.  Will increased payment increase these numbers?  Probably not.

So far on the Jardine watch there has been a significant degeneration in both ethics and practice of assisted reproductive technologies.  For example, in July 2009, a British woman gave birth to a baby boy after scientists had screened her ova for chromosomal abnormalities.  The HFEA had previously approved a licence for Simon Fishel, director of the Care Fertility Group in Nottingham, to use this novel technique.  Called array comparative genomic hybridisation, it scans ova for abnormalities such as extra or absent chromosomes.  True, destroying unwanted ova is not in the same league as destroying surplus embryos, but it is still a eugenic procedure.

Furthermore, from September, Professor Jardine and the rest of the HFEA now preside over fertility treatments (begun after 6 April 2009) that allow lesbian couples to enter both their names on the birth certificate of a child born to one of them.  The HFEA would no doubt argue that it was simply implementing changes brought about by the Human Fertilisation and Embryology Act 2008.  Nevertheless, approving IVF is one thing, colluding in legal falsehood is quite another – after all, half of the ‘parental’ names on these certificates have no genetic relationship to the child.  It is yet another corrosive element in our understanding of the family – no decent citizen should promote that policy.

With regard to the new provisions of the HFE Act 2008, there is not much good in any of them.  To give a flavour of the tangle we have now permitted, consider just two items.  First, from the HFEA’s new online Frequently Asked Questions (FAQs) section, ‘Can the male intended parent in a surrogacy arrangement be the legal father where treatment is with donated sperm?’ Be honest, you had never even thought of that question had you?  And the HFEA’s answer is, ‘Yes this may be possible.  The surrogate would be the legal mother of the child.  Speak to your clinic to make sure the correct consents are signed.’  Second, there are now 16 (yes, sixteen) different consent forms for various aspects of fertility treatment.  These include the straightforward, ‘Consent to the use and storage of your sperm and embryos for your partner's treatment’ to the more esoteric, ‘Consent to your partner being the legal parent’.  How much simpler pregnancy used to be!  The men in white coats and the lawyers have taken over.

One of the nightmares for IVF clinics must be mix-ups of patients’ sperm, ova and embryos.  Some obvious cases have come to light, like the white woman who gave birth to black twins in Leeds in 2002.  Or, as occurred earlier this year, Cardiff and Vale NHS Trust having to pay undisclosed damages to a couple whose last remaining embryo was transferred to the wrong woman.

But there are also too many anecdotal reports of disregard for the HFEA rules – errors in patient’s notes, missing signatures, lax procedural security.  One witness of such misdemeanours, who became a whistleblower, was Bea Pavlovic, a clinical embryologist at Guy’s Hospital, London.  She complained to the HFEA.  For her trouble she got the sack and in November 2008 came within a whisker of being struck off the medical register.  But earlier this year it was revealed that she was right, there had indeed been mistakes at Guy’s – the wrong sperm had been injected into the wrong ova.

How to minimise such disasters?  One attempt is about to be implemented at the Liverpool Women's Hospital, which plans to be the largest IVF centre in Europe – it will electronically tag embryos.  Surely a more effective strategy is for the HFEA to apply beefy sanctions against clinics which ignore or flout its safety guidelines, after all, the HFEA is called a watchdog, so it should both bark and bite.  What is Professor Jardine’s view on this?  She believes that the HFEA is already tough enough and that implementing too strict a regime might drive patients to IVF clinics abroad.  Oh, no!

To give a real insight into Jardine’s thinking, consider this.  In September 2009, she called for a debate on two topics – namely, gamete donation to a known family member of a different generation, and the provision of gametes between siblings.  The first is known as ‘intergenerational donation’, and is exemplified by the 72-year-old British man who donated sperm to his daughter-in-law.  The second could be the donation of semen by a man to his sister if she is using a donated ovum.  In other words, the head of the HFEA is keen on, for instance, a brother being an uncle as well as the biological father in order to help his sister.  She apparently has no qualms about upsetting traditional parenthood and family structure – she probably sees them as merely ‘culturally-specific beliefs’.

Finally, here is a little test of Jardine’s bioethical fortitude.  Currently the HFEA allows the use of preimplantation genetic diagnosis (PGD) for ‘medical reasons’, meaning the detection of genetic diseases, in IVF embryos, but bans it for the testing of the embryo’s sex for ‘social reasons’.  As a result, some British couples are travelling to the USA and elsewhere to enable them to select the sex of their IVF children.  How long will it be before Jardine and the HFEA capitulate and allow PGD for sex determination in the UK for so-called ‘family balancing’ or to ‘replace’ a deceased son or daughter?  One year, three, or five?  Watch this space!  One potential brake on such a change is that sex selection generally results in the destruction of more female embryos.  Caroline Flint, the health minister, who steered the HFE Act 2008, noted this fact in the Parliamentary debates, and it will not have escaped the notice of Professor Jardine either.

We have long been alarmed by the bioethical and administrative lurching at the HFEA – incompetence and unethical decision making have become its forte.  This drift looks like continuing, even worsening, under its new chairman.  Lisa Jardine looks like a dangerous woman.

Human Embryonic Stem Cell Trial – Why?
In January 2009, the Geron Corporation was granted permission by the Food and Drug Administration (FDA) to conduct the first US human trial using embryonic stem cells.

The plan was to coax these cells to develop into oligodendrocytes, which would provide insulation and growth factors needed to repair damaged nerve cells.  These cells, called GRNOPC1, would then be injected into ten or so paralyzed patients, who had recently severed their spinal cords.  The excitement among the hESC (human embryonic stem cell) community was palpable.

However, in mid-August, Geron announced that the FDA had halted Phase 1 of the trial, which was intended to test the safety of such a potential treatment.  At the end of August, the California-based biotechnology firm stated that the postponement was because cysts had developed in some of their laboratory animals undergoing analogous treatments.  Apparently the risk in leaping from mice to men was too great.

The whole affair has a political smell about it because the trial was initially approved just days after the Obama inauguration.  Some of us remember the hype surrounding the predicted cures from so-called human gene therapy during the 1990s – serious safety issues have largely returned that to the medical doldrums.

The key question to ask Geron executives and scientists is, why bother with this proposed trial?  Here are four reasons to abandon it.  It is unethical because the extraction of stem cells from embryos destroys them.  Similar trials with animals have been plagued by the development of tumours thus raising doubts about safety.  Treatments for spinal cord damage with adult human stem cells have already yielded good results.  And furthermore, induced pluripotent stem (iPS) cells, discovered within the last two years, hold out vast, additional prospects for the development of successful and ethical therapies.

Incidentally, huge strides are being made in the production of these iPS cells. When the first human iPS cells were generated (in 2007), they required the presence of four transcription factors (namely, OCT4, SOX2, c-Myc and KLF4).  These were problematic because at least two of them were linked to the development of cancerous cells.  In 2008, further experiments showed that just two of these factors were required, and in August 2009, so-called ‘one-factor human iPS cells’ were produced using only OCT4.  As the Germany-led research team stated, ‘One-factor iPS cell generation will advance the field further towards understanding reprogramming and generating patient-specific pluripotent stem cells.’  So, why persist in destroying human embryos, Geron?

Abortion Reforms in the USA
We may have lost all the battles in the UK to limit abortion, but elsewhere the fight goes on, especially in the USA.

For example, in Oklahoma a state law was passed in August 2009 that required women who were seeking an abortion to view ultrasound images of their unborn child.  The very next day a certain Judge Robertson repealed it, albeit on a technicality. Nevertheless, the State said it would appeal against this ruling.  The battle is set to continue for several months and may yet reach the State Supreme Court.

The Oklahoma bill, often categorised as an ‘informed consent law’, is not atypical because at least three states, namely Alabama, Louisiana and Mississippi, already require doctors to offer the pregnant woman the chance to see ultrasound images before she consents to an abortion.  But the Oklahoma bill went one step further.  It required the doctor or a technician to set up the ultrasound monitor where the woman could see it and then talk her through the procedure, describing the heart, limbs, internal organs and so on.  The woman would, the proposed law stated, be allowed to ‘avert her eyes’.

The bill’s sponsor, Senator Todd Lamb, said, ‘Before that mother goes through the procedure, we believe it is positive public policy to give her as much information as possible about that baby.  She might just change her mind and, who knows, that baby could be a future Nobel Prize winner.’

Beyond mandating ultrasounds, the Oklahoma bill would have allowed doctors to refuse to take part in an abortion for religious reasons, required signs in clinics stating that abortions cannot be coerced and it would also have prohibited ‘wrongful-life lawsuits’ in which a plaintiff could argue that a disabled child would have been better off not being born.  Additionally, it would have put restrictions on the supply and use of the morning-after pill.

A similar state of affairs has been rumbling on in South Dakota since 2005.  Its informed consent law for abortion recently survived a legal challenge from the powerful abortion provider, Planned Parenthood.  Though a judge struck down some parts of the law, he also ruled that doctors must continue to tell pregnant women that abortions, ‘… terminate the life of a whole, separate, unique, living, human being.’  Well, there is nothing like telling the truth, is there?

Meanwhile, the Obama Administration is causing its own disquiet over the possible extension of federal abortion law.  Some fear that the President and Democratic leaders in Congress are trying to smuggle easier access to abortion on demand, including the federal funding of abortion, under the guise of their ‘health care reform’ legislation.  If passed, these reforms could result in the greatest expansion of US abortion since the 1973 landmark decision in the case of Roe v. Wade.

Bioethics in the East
Bioethical issues are not the preserve of the West.  The East also creates its own appliance-of-science dilemmas.  For example, in common with many other countries (including almost all in the West), China is facing a demographic catastrophe its proportion of elderly people is growing at such a rate that there are insufficient workers to pay for its retired population.  Of course, China’s dilemma has been exacerbated by its one-child policy.  Now, officials in the country’s most populous city, Shanghai, are actively urging parents, who themselves were only children, to have a second child.

This new and surprising strategy comes at the same time as the latest Chinese official figures show that abortions, both enforced and optional, have reach record levels.  The annual total for China has now reached more than 13 million abortions, a marked increase on the figure of 9 million from 2003, when the last statistics were released.

China has recently gained a regrettable reputation for marketing unproven stem-cell therapies that have attracted gullible patients from around the world.  Thankfully, China is now developing the more serious and sound business of cellular reprogramming with iPS cells.  One of the big questions surrounding iPS cells is this: are they as versatile as embryonic stem cells?  In other words, can iPS cells be transformed into all 200 or so cell types that constitute a complete living creature?  Using iPS cells to create live offspring with normal organs and body tissues would be an essential test of such versatility.  Chinese scientists have recently achieved just that with mice.

Two teams, working separately in the Chinese Academy of Sciences and the National Institute of Biological Sciences in Beijing, reported that they have reprogrammed skin cells from adult mice to an embryonic-like state.  That in itself is significant, but they then used the resulting iPS cells to create live mouse offspring by injecting them into mouse placental cells called blastocytes, also known as ‘tetraploid embryos’, which can develop only into placental material and the other cells necessary for development, but not the true embryonic cells that would become the body – they have been likened to a car without a driver.  Some of these subsequently developed into healthy mouse cloned pups, which in turn matured and produced their own offspring.  DNA testing confirmed that the first mouse produced this way had indeed arisen from the iPS cells – he was named Xiao Xiao, which is Mandarin for Tiny.

This is an important ‘test of principle’ because it demonstrates that adult mammalian cells can be reprogrammed to reacquire the entire range of body cell types, that is, they can attain true pluripotency, just like embryonic stem cells.  The technique is called tetraploid complementation and if it were applicable to humans it could produce limitless supplies of a person’s own stem cells and therefore mark another step towards iPS cell therapies for humans.  The downside is that this work also demonstrates the relative ease with which human clones and designer babies could be produced.

From China to Korea.  Remember back in 2004 and 2005, when the Korean researcher, Hwang Woo-suk, cooked the books and published falsified data in the journal Science claiming to have produced the world's first cloned human embryonic cell lines?  He was fired from his professorial post at the Seoul National University and banned from again undertaking stem cell research.  In the meantime, he kept himself busy by setting up a joint US-Korean company to clone pet dogs after he produced the world’s first cloned dog, an Afghan hound named Snuppy, a portmanteau of the initials of the Seoul National University (SNU) and ‘puppy’.

Though still disgraced, in April the Korean government saw fit to lift Hwang’s research ban and in June 2009 he was awarded the Jang Yeong-sil prize for Scientist of the Year.  I know, I cannot believe it either!  Now he is before the courts again.  This time he is accused of embezzling something like $2 million from government research grants if found guilty, he faces a possible four-year jail sentence.

East or West, bioethical issues commonly know no boundaries, both in the geographical and the ethical sense of that phrase.

Assisted Suicide and the Law
On Wednesday 23 September 2009, the Director Public Prosecutions, Kier Starmer QC, published interim guidance on whether or not to prosecute those involved in acts of assisted suicide.

On 30 July, Mr Starmer had been ordered to produce these guidelines by the Law Lords after they had heard the appeal by Debbie Purdy, a multiple sclerosis sufferer.  She wanted to know under what circumstances her husband would fall foul of Section 2(1) of the 1961 Suicide Act and be prosecuted for helping her to die at the Dignitas ‘clinic’ in Switzerland.

Mr Starmer has outlined sixteen ‘public interest factors’ likely to favour a prosecution and thirteen factors against taking legal action.  These can be read at www.cps.gov.uk/consultations/as_policy.html  This online interim document also includes nine questions which constitute a public consultation exercise that closes on 16 December 2009.  A final policy will be published in Spring 2010.

Committing or attempting to commit suicide is not in itself a criminal offence – assisting is.  The 1961 Act defines assisting a suicide as 'aiding, abetting, counselling or procuring' the suicide of another, and it carries a maximum penalty of fourteen years imprisonment.  These new guidelines were not intended to alter the law on assisted suicide – only Parliament should do that.  Nor do they provide an individual with any assurance of immunity from prosecution.  However, what they do say is that sometimes it will not be unlawful to assist a suicide – if, for example, the victim is a family member, over 18 years old and not suffering from a mental illness or learning difficulty, and is assisted by someone ‘wholly motivated by compassion’, then that is OK, no prosecution will follow.

On the other hand, those who assist and who might gain financially from the victim’s death, are more likely to be prosecuted.  Yet most assisters are going to be close family members who will probably, albeit perhaps unintentionally, gain monetarily from the victim’s death.  So how will compassion be weighed against benefit?  In effect the law has been changed – a suicide has been assisted, a crime has been committed, but now it can be overlooked because it is deemed to be just a crime of compassion.

This legal farrago represents the latest skirmish in a carefully-orchestrated and well-funded campaign by pro-euthanasia proponents, spearheaded by the Dignity in Dying organisation, formerly known as the Voluntary Euthanasia Society (VES).  And this is despite the House of Lords rejecting any change to the law in 2006 and the House of Commons doing the same earlier this year by rejecting Lord Falconer’s amendment to the Coroners and Justice Bill.

These guidelines will put the elderly, the infirm and the vulnerable at greater risk.  How our country’s bureaucracies, and now even our justice system, have become enamoured with the tick-box agenda.  The 1961 Act was pretty unequivocal, now it will be subjected to a fuzzy, sort of 6 ‘for’ versus 2 ‘against’ decision-making process.  Next year, or thereabouts, there will be calls for this new-fangled version of the Suicide Act to be repealed because it will prove to be unworkable and inequitable.  The law will have truly become the ass.  After that, Dignitas ‘clinics’ will be franchised across the UK.

Maybe not.  But the truly cheerless prospect is this – once the brake on assisted suicide has been slackened, once it is regarded as not unlawful, the few victims will become the many.  As ever, the history of abortion is the forlorn paradigm.  Assisted suicide, as a side shoot of euthanasia, will then grow into the full-blown thing.  Then the circle of human destruction will be complete – from womb to tomb – man, the master of his own (and everybody else’s) destiny.

Dr Francis S. Collins
Most readers will not recognise this name – Francis Collins.  Yet he is perhaps the most powerful man in the world of biological research.  He is a highly-acclaimed geneticist and he was the former leader of the worldwide Human Genome Project.  Now President Barack Obama has appointed him as the director of the National Institutes of Health (NIH).

The appointment of Collins is interesting and controversial, on at least three levels.  First, the NIH is undoubtedly powerful – it is the USA’s gigantic medical research council, which this year will donate $40 billion to the biological sciences.  Second, Collins was appointed just two days after the NIH released its new, and permissive, guidelines governing human embryonic stem cell (hESC) research.  Third, Collins is an evangelical Christian.

The appointment of Collins has been viewed with suspicion on all sides.  Christians ask, how can an evangelical support research which destroys human embryos?  Francis Collins also supports therapeutic human cloning.  On the other hand, he has dismissed the existence of a ‘gay’ gene that would predetermine homosexual behaviour.  And he is a staunch opponent of atheistic Darwinian evolution and he has debated against Richard Dawkins, though he describes himself as a ‘theistic evolutionist’.

Then secular humanists ask, how can a proper scientist have fundamental religious convictions?  In 2006, Collins wrote The Language of God: A Scientist Presents Evidence for Belief.  In it he argues that, ‘… belief in God can be an entirely rational choice, and that the principles of faith are, in fact, complementary with the principles of science.’  Moreover, he also described how, as a 27-year-old scientist, his life-changing conversion was due in part to his reading C. S. Lewis's Mere Christianity.

Collins has stated, ‘In my view there is no conflict in being a rigorous scientist and a person who believes in a God who takes a personal interest in each one of us.  Science's domain is to explore nature.  God's domain is in the spiritual world, a realm not possible to explore with the tools and language of science.  It must be examined with the heart, the mind, and the soul – and the mind must find a way to embrace both realms.’

Poor Francis Collins.  His high-profile stance for the truths of Christianity has drawn the ire of the atheists, and if we are not careful we will condemn the man too.  Many of us hope and pray that evangelicals will attain high public office and then stand firm for Jesus Christ.  Yet when such a man arrives there we can so easily nitpick and pull him down.  Ask yourself, how would you fare?  Would you, for example, make a good mayor of your town?  Our proper response must be to pray for Francis Collins, that he may stand for truth and bring glory to God – just like Daniel did.

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