Why I Did Not Send A NICE Reply

NICE (the National Institute for Clinical Excellence) is part of the UK’s National Health Service (NHS). It is an independent organisation responsible for providing guidance on treatments and care for those using the NHS in England and Wales.

On 26 August 2003, NICE issued the second draft of clinical guidelines on the assessment and management of fertility problems. There was a four-week consultation period, which ended on 22 September. NICE is expected to put its final recommendations to the Government in February 2004.

The full version of the guidelines is 281 pages long. There are 20 chapters, plus an appendix, of recommendations about infertility techniques and protocols, most of which are highly technical – I certainly did not read them all. But, if you are sufficiently stout-hearted, you can check them out at www.nice.org.uk/cat.asp?c=20092.

Briefly, the key recommendation was that women, between the ages of 23 and 39, should be entitled to have three cycles of IVF treatment free on the NHS if they have failed to conceive naturally after three years, or immediately if they have a clear cause for their infertility and are under 23. This would end the so-called ‘postcode lottery’, whereby some couples already get free IVF on the NHS, while others, because of their geographical location, have to pay for it privately.

I did not make a submission to NICE. Of course, I wanted to respond. I want to respond to all these sorts of bioethical issues – during the consultation period, I took part in an hour-long BBC radio programme on this very topic. But, this NICE consultation created a problem, or rather a set of at least four problems, for me.

1] It was a strange consultation exercise. While NICE said that it welcomed comments from all-comers, the exercise was aimed mainly at the so-called ‘registered stakeholders organisations’, which are almost exclusively practitioner groups, like the Royal College of Gynaecologists and the British Fertility Society. Neither I, nor the organisations I serve, are registered as stakeholders.

2] Furthermore, the document’s rubric stated that, ‘In referring this guideline to NICE for development, the Secretary of State for Health and the Welsh Assembly Government have made clear their decision to standardise access to fertility treatment across the NHS in England and Wales.’ That is, Westminster and Cardiff saw this consultation primarily as an issue of equality, to end the ‘postcode lottery’ of NHS provision of infertility treatments. I would find it pretty hard to argue against ‘equality’ – a cardinal principle of justice is that equal cases are treated equally.

3] The rubric continued, ‘NICE is not tasked with looking at the affordability of fertility treatment, nor the social issues around its use. Our job is to produce a treatment guideline which supports the NHS in diagnosing fertility problems and, once the diagnosis is confirmed, managing treatment.’ In other words, IVF and all the other assisted reproductive techniques are a given – there were no bioethical arguments that NICE wanted to hear. I searched the document for words such as ‘bioethics’, ‘ethics’, ‘morals’, ‘thinking’, and ‘philosophy’ – all were entirely absent.

4] And instead of presenting a decently-argued submission with developed themes, with a beginning, a middle, and an end, all responses to NICE had to be submitted on the provided e-mail proforma, together with strict reference to the particular paragraph of the guidelines. This sort of presentation militates against anything I would want to, or even could, write. Sadly, this rigidly-structured, box-ticking type of exercise is fast becoming the norm for Government and NGO consultations.

These were the main reasons why I did not write a NICE reply. If you are disappointed, I am probably more so. However, let me outline the sort of arguments that I would like to have presented to NICE.


The Bioethical Objections
The proposal for three free treatment cycles of IVF gives the procedure a status that it does not deserve. Although NICE might pretend to be deaf to bioethical arguments, IVF is not bioethically neutral. IVF inevitably involves experimenting with human embryos, and discarding vast numbers of them, already as many as 1.2 million in the UK alone. This is not a small objection to IVF.#


As well as this destruction of human embryos, IVF has other bioethical problems. Chief among these is its failure rate. This remains at about 80%, though this is usually regarded as a 20% success rate. But which other medical intervention does the NHS fund that has such a wholesale failure rate? Would you submit to a major medical procedure with odds of 4 to 1 against being successful? For a medical treatment to be regarded as ethical, and appropriate for widespread use, it must be both more reliable and less experimental.

Of course, some men and women are, and some always will be, infertile – perhaps they produce no sperm, or no ova. This is nothing new. But society needs to be very sensitive towards such people – pressing home the subliminal message, endlessly broadcast by the IVF industry, that you are not a real woman or man unless you become a mother or a father can be an offensive matter. For them the ‘over-egged’ carrot of free IVF will become more like a poke in the eye.

The Medical Objections
Amid this clamour for IVF – which, predictably has been welcomed by private practitioners of IVF, who will be lucratively (at £3000 to £5000 per treatment cycle) drafted in to cope with an overwhelmed NHS – its other costs have been conveniently sidelined. Yet, IVF typically entails a physical cost with its constant regimes of injections and monitoring, white-coated technicians and all the other trappings of hi-tech medicine. The inevitable super-ovulation treatment is often uncomfortable, but it can also lead to the serious dangers of ovarian hyperstimulation syndrome (OHSS). And there are psychological costs too. These are normally characterized by heightened stress, and sometimes by relationship failure between the couple, and with any gamete-donating third parties. For many, there will also be the crushing disappointment of IVF failure, which can so easily be translated as personal failure. Then there are the problems associated with multiple births – half of all successful IVF treatments end with twins or triplets. Such births are associated with maternal health problems, low birth weights, high rates of stillbirth, neonatal deaths and long-term disabilities.

And now IVF has some ‘new’ problems. Within the last year or two a worrying number of serious conditions associated with IVF and its variant, ICSI (intra-cytoplasmic sperm injection) have been reported. Children conceived in these ways have twice the rate of birth defects compared with naturally-conceived children. Specifically, the incidence of Beckwith-Wiedermann syndrome (‘large offspring’ syndrome), retinoblastoma (cancer of the retina), Angelman syndrome (growth and behavioural problems) and Turner’s syndrome (abnormal growth and development) is greater in children conceived by IVF or ICSI. In addition, miscarriages have been shown to be considerably more common after IVF than after natural conception.

Even Lord Robert Winston, one of the UK’s foremost IVF proponents, has warned against the dangers of using IVF with, for example, frozen embryos, a procedure that has never been properly assessed. These concerns beg the question, are there other hidden dangers and diseases in later life caused by IVF? The truth is that the long-term risks of IVF treatment have not been assessed and this has been likened recently to ‘a mass experiment on children’s health’.

The Sociological Objections
Marriage is not mentioned in the NICE guidelines. That is, practitioners of assisted reproductive techniques under the NHS do not need to consider the marital status of the infertile couple. Yet, for the vast majority of the ‘morally sensitive’ this is a fundamental issue. Marriage, though currently under threat from libertarians, is still generally recognised as the best and safest place in which to conceive and nurture children. It is interesting to note that LIFE has recently reaffirmed its commitment to accept and treat only married couples on its fertility programme (see, www.lifefertility.co.uk).

Is portraying IVF as the answer to infertility a technology too far? It will increasingly encourage the idea that babies can be obtained ‘on demand’, which is another step down the road of the commodification of our children. We should ask, must procreation also now be fitted into our already over-timetabled lives? This technological intrusion into one of the most profound areas of human relationships tells us a great deal - perhaps too much - about our values and how we view ourselves and others, especially our offspring.

And will NICE’s proposed free IVF encourage the wrong sort of people to use it for the wrong sort of reasons? That is, are more and more women choosing ‘voluntary infertility’ as a lifestyle and then expecting IVF to fix it later. Certainly, ‘career women’ continue to put off childbirth, and it is noticeable that the abortion rate among these twentysomethings is still the highest of all age groups. So, as these thirtysomethings decide to settle down to family life, and others decide to start families with new partners for a second time, it must be asked, is IVF being increasingly used for less-than-serious reasons? Herein is the completion of a rather ominous circle of medical intervention - women are already using medical means (abortion, morning-after pill, etc.) to stop pregnancy, now, the NICE recommendations want more women to use other medical means (IVF, ICSI, etc) to start pregnancy.

Our society has sent out the wrong signals to couples. The catchphrases, ‘the freedom to choose’, ‘total control of your fertility’, ‘the professionalisation of parenthood’, have all created a climate in which IVF is seen as the answer for those who are voluntarily and involuntarily sub-fertile. But IVF is not this panacea. Sadly, if IVF is increasingly regarded as the final hope of many, then many will be disappointed.


The Political Objections
The NICE proposals raise other questions. Such as, is it right for a publicly-funded health service to offer such provision? Are these the values and priorities that we want the NHS to uphold? Is human reproduction an area in which society should be making decisions? Clearly the Government has been loath to make such judgments – that is why NICE was handed this hot potato in the first place.

Even if the NICE recommendations are accepted, it is far from clear if the Government will stump up the necessary cash. And the bill could be huge - some have estimated that the price tag would be £100m, or even as high as £400m, each year.

In recent years the NHS has moved towards a more decentralised structure whereby local needs and priorities are assessed and then funded according to local spending plans. If local decision-makers decide that IVF is neither a priority, nor good value for money, will anything change? In other words, should a national IVF policy even be contemplated, and could it ever work?

Nevertheless, if the Government is serious about treating infertility, rather than simply alleviating it with IVF, then it should look at some other issues. Delaying childbirth is an undoubted problem – the mother’s age is a major factor in infertility and the average age of first-time motherhood is now approaching 30. Yet Government does little to encourage young couples to start families by, for example, tax breaks and other incentives – the relentless push of this Government has been to get everyone, young women especially, into work, preferably full-time. Contrary to this zeitgeist is that immovable truth that motherhood is wonderful, important and fulfilling – and biologically, the sooner it is started the better.

Another area the Government should proactively tackle is couples’ preconceptual health. There is a growing corpus of evidence to show that sub-fertility is exacerbated by stress, obesity, drug abuse, sexually-transmitted diseases, smoking, and so on. Spending money to ameliorate these problems would be an ethical, cost-effective and successful way of helping the childless.

The Legal Objections

While it cannot be denied that IVF is legal in the UK, none can be content with the legal problems it has generated. Every month someone is in court challenging the ‘ownership’ of frozen human embryos after couples split up, the mix-up of embryos during IVF treatment, posthumous fatherhood, the deceit and shenanigans of IVF doctors, and so on.

Indeed, the courts are now being pushed to decide questions of morality rather than law. Parliamentary responsibility is being undermined.  And while the head of the Human Fertilisation and Embryology Authority (HFEA) is pressing for Parliament to revise the Human Fertilisation and Embryology Act 1990, there seems to be little political will to do so.

The Objective Objection
Faced with the objections outlined above, can any doubt that we would all be better off without IVF? What a mess – bioethically, medically, sociologically, politically and legally- it has generated. We certainly do not want more of it, as NICE is calling for. Even so, in the interim, common sense may prevail. Money, specifically, lack of it, will probably squash these NICE proposals. Certainly during the radio phone-in programme in which I participated, the vast majority of callers considered the proposals foolish on the grounds of cost alone. When it comes to granny’s hip operation versus some IVF, there is no contest in the minds of most people.


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