‘One at a Time’: an attack on choice

The Human Fertilisation and Embryology Bill, which is nearing the completion of its passage through the UK parliament, stands to overhaul Britain’s fertility and embryo research legislation.

In large part, this will be for the better, even if the way that the issue of abortion has been sidelined in the Bill’s latter stages leaves much to be desired (see A shocking betrayal of women’s rights by Ann Furedi). But while the issues dealt with in the new legislation have provoked fierce debate, significant regulation continues to be implemented under the terms of established fertility law.

One such piece of regulation, which will come into force in January 2009, concerns the number of embryos that can be transferred to the uterus of women undergoing in vitro fertilisation (IVF) treatment. In IVF, eggs are extracted from a woman and fertilised by a man’s sperm in a laboratory, and the resulting embryos are then returned to the woman’s uterus, usually as a means of helping otherwise infertile people have children. Broadly speaking, increasing the number of embryos transferred increases the chance that at least one of them will adhere to the wall of the uterus and result in a pregnancy. But this process simultaneously increases the chance that the patient will become pregnant with two or more fetuses.

The trouble with multiple births

All pregnancy involves some degree of risk, to both the mother and the prospective child, and medical practitioners are in the business of mitigating this risk. The risk is significantly increased, however, in the case of multiple pregnancies. Potential problems that can become more likely in the case of twins or triplets include glucose intolerance, haemorrhage, hypertension and preeclampsia in the mother, and premature birth, perinatal death (including miscarriage and stillbirth) and subsequent disability (particularly cerebral palsy) in the twins or triplets. Bundled in with these are the ‘psychosocial’ problems of twins and triplets being more stressful and expensive to look after, although the construction of these problems is more open to critique from non-biomedical perspectives (1).

In short, IVF treatment presents regulators with something of a conundrum. When the medical profession strives to increase the chances of a woman becoming pregnant, and when doing this results in a correspondingly increased chance of a multiple pregnancy, then the profession is arguably serving contrary interests. In other words, medical practitioners seem to increase risks that they will subsequently need to mitigate. This is why multiple births as a consequence of multiple embryo transfer in IVF treatment are referred to as ‘iatrogenic’. The term’s literal meaning is simply ‘brought forth by a healer’, but it is often used pejoratively to refer to the exacerbation of a medical problem by those attempting to treat it.

The conundrum is made thornier by the fact that although IVF should be available free of charge in the UK, this is not always the case, and the number of cycles of treatment provided free is limited. Where patients are being treated privately, they may be paying thousands of pounds for treatment. Given the fact that IVF success rates also remain relatively low, patients are keen to maximise their chances of success, even if that means increasing the chances of other problems arising. Add to the equation the politicisation of health and motherhood that has been documented extensively on spiked and it all adds up to much agonising by officialdom over the subject of multiple births.

Since it was first established by the passing of the original Human Fertilisation and Embryology Act in 1990, the Human Fertilisation and Embryology Authority (HFEA) has sought to limit the number of embryos transferred to IVF patients. But over time, these limits have become ever stricter. The first edition of the HFEA Code of Practice in 1991 established a limit of three embryos transferred per IVF cycle (each ‘cycle’ of IVF treatment is one round of stimulating egg production in a patient, extracting and attempting to fertilise the eggs, and then transferring one or more resulting embryos to the patient’s uterus). In 2001, and again in more binding form in 2004, this was tightened up to a limit of two embryos. In 2006, an Expert Group on Multiple Births After IVF suggested that the HFEA reduce the limit further to one embryo (2).

When ‘election’ means little choice

The HFEA has acted on this advice, and this year wrote to all the local health providers in the UK, the Primary Care Trusts (PCTs), saying that ‘the single biggest issue that faces mothers and babies following assisted conception’ is ‘the impact that multiple births has on public health’. (This may have come as something of a surprise to anyone who thought that the single biggest issue facing IVF patients was trying to have babies.) In partnership with various professional bodies and patient groups, the HFEA launched a ‘One at a Time’ campaign ‘aimed at reducing the risks of multiple pregnancies from fertility treatment’ (3). As of next year, elective single embryo transfer (eSET) for women under 40 will be official HFEA policy.

The ‘e’ in ‘eSET’ refers to the fact that patients and practitioners can still opt for multiple embryo transfer in specific instances. This latitude notwithstanding, public and private fertility clinics will be required from January 2009 to ‘maintain a documentary record of the licenced centre’s Multiple Births Minimisation Strategy… the outcome of regular audits and evaluations of the progress and effectiveness of the strategy… and a summary log of cases in which multiple embryos have been transferred to a patient who meets the criteria for single embryo transfer as set out in the strategy’. Where multiple embryos are transferred, clinics must provide the HFEA with ‘a clear explanation of the reasons for transferring more than one embryo in that particular case’ and ‘a note confirming that the risks associated with multiple pregnancy have been fully discussed with the patient’ (4).

In addition to the professional bodies and patient groups that support the ‘One at a Time’ campaign, fertility clinics also seem happy to comply with the new regime, not least because they are grateful that the HFEA did not impose a stricter policy upon them. Of the four different options for promoting eSET that the HFEA considered during a public consultation in 2007, the one it eventually chose – requiring all clinics to have a ‘Multiple Births Minimisation Strategy’ and to be compelled to justify any deviation from this strategy – was the one characterised as ‘very flexible’ in the original consultation document. Less flexible options would have involved setting a ‘maximum twin rate’ for each clinic, or else defining rigidly in which circumstances multiple embryo transfer would be permitted (5).

Even if practitioners appear (in public) to be content with the ‘very flexible’ policy that the HFEA settled upon, this does not exempt the policy from criticism. For one thing, while stricter policies would have been contentious, they might have had the merit of clarity and the burden of specific biomedical justification. By contrast, encouraging every clinic to adopt its own strategy and (in the words of the consultation document) ‘increase awareness of risks of multiple births’ is a more insidious form of coercion. The new rules require clinicians to stay ‘on message’ while enabling the HFEA to claim that patients can still exercise freedom of choice – even if this is the sort of ‘informed choice’, not uncommon under New Labour, where one suspects that ‘informed’ is being used as a synonym for ‘correct’.

For another thing, there is the patient view to consider – if the HFEA’s consultation exercise on multiple births is anything to go by, then it gives the lie to the ‘e’ in ‘eSET’. As reported in the HFEA summary, ‘most patients responding to the written consultation felt that they had enough information on the risks of multiple births. In fact, 24 per cent felt that the risks were overemphasised.’ Of the latter, ‘most… thought that the risks associated with twins are overstated or that all pregnancies, whether singleton, twin, IVF or non-IVF have risks associated with them’. Furthermore, ‘the overwhelming concern for patients was that wide use of single embryo transfer would mean a greater restriction on their choice’ (6).

A dim view of patients

In response to this, HFEA members remarked that ‘although awareness of the risks of multiple birth is quite high, patients may not understand and appreciate the significance of those facts especially against the context of their very strong wish to have a baby’ (7). Patients and the broader public could take offence at several aspects of this statement – at the suggestions that patients who are aware of risks but have a different opinion of them than the regulator have failed to ‘understand and appreciate’ those risks; at the suggestion that the ‘very strong wish to have a baby’ is some sort of irrational fog that impedes the comprehension of risk; and at the suggestion that after the regulator goes out of its way to solicit the views of the lay public on a proposed policy, it can then dismiss these views as inexpert at its convenience.

One organisation that took offence in this way was the Twins and Multiple Births Association, whose chief executive complained that ‘in the face of such overwhelming opposition, it beggars belief that they have decided to carry on regardless’ (8). Aside from this, however, the most outspoken criticism of the new policy has focused not on multiple births as such, but on the inequity of measures to reduce multiple birth that also reduce the chances of IVF patients conceiving, when those unable to afford private IVF treatment are offered so few chances on the NHS to begin with.

To illustrate this inequity, a clinical guideline issued in 2004 by the National Institute for Clinical Excellence (NICE) specifies that 23- to 39-year-old patients are entitled to expect three free cycles of IVF treatment on the National Health Service (NHS). Despite this, fewer than one in ten PCTs actually offers three cycles, with the remainder offering either one or two cycles or no cycles at all. Thus IVF provision joins the ranks of the many public services that can legitimately be criticised as a ‘postcode lottery’. Organisations representing the infertile understandably find it a bit rich for the authorities to issue regulation promoting single embryo transfer when health providers appear reluctant to hold up their end of the bargain by providing the nationally specified access to treatment (9).

Some have used this as an argument in favour of eSET, on the grounds that free IVF treatment could be consistently and affordably offered across the NHS if eSET were universally adopted, because the savings made by avoiding the burden of multiple births on neonatal, paediatric, education and social services would result in no net loss (and possibly a net benefit) to the public purse. Furthermore, interesting work is being done on IVF methods that increase the chances of conception even when only one embryo is transferred, and further progress in this direction may render moot the argument that eSET unfairly reduces opportunities to conceive (10).

Good science and bad faith

But for all of the good biomedical and policy reasons to support the minimisation of multiple births, there remains a certain aura of bad faith surrounding the ‘e’ in ‘eSET’ – that is, the notion that women really have a choice. To begin with, it’s worth noting that reducing the number of embryos transferred to the uterus is not the only way of avoiding multiple births. If the number of embryos present is thought to pose a risk later in pregnancy, then this number can be reduced through selective abortion. This procedure, known as multifetal pregnancy reduction (MFPR), was dismissed early on in the development of the HFEA’s new policy, with the Expert Group on Multiple Births stating in 2006 that ‘without repeating all the moral arguments about abortion, it is obvious to our group that eSET is the preferable option’ (11). This is as pusillanimous, in its own way, as the evasion of the abortion question by the government during this month’s debate of the HFE Bill in parliament.

The ‘One at a Time’ campaign also fails to acknowledge, much less reflect, the weight of public opinion on multiple births evident from the HFEA’s consultation, and thereby forecloses public debate about the subject. Anything that muddles the campaign message is frowned upon, as I discovered at the HFEA’s annual conference earlier this month when my line of critical questioning about HFEA policy on multiple births earned a sharp rebuke from the regulator’s chair Lisa Jardine, who (wrongly) assumed from my remarks that I couldn’t possibly be familiar with the ‘One at a Time’ campaign literature.

Similar opprobrium was heaped on the authors of a recent article in the medical journal Fertility and Sterility, which suggested that twin pregnancies did not pose as much of a risk as was previously thought, and that therefore patients receiving fertility treatment have ‘reduced their pregnancy chances for no obvious benefit’. Experts from the ‘One at a Time’ campaign issued what was, in fairness, a useful refutation of this paper, but the response concluded that ‘whatever the hypothesis, which may be interesting for doctors to mull over and discuss, there are significant risks to multiple pregnancies, and we should not be generating them deliberately’ (12).

Let patients decide

This points to two fundamental problems with the campaign to minimise multiple births. First, it is assumed that while experts should be free to dispute the detail of the science, the public should be given the simple version so as not to risk confusing them.

There are other areas of public health where such a stance might be more legitimate, most notably vaccination. As Dr Michael Fitzpatrick has argued on spiked and elsewhere, government equivocation on the question of whether the MMR vaccine is connected with autism has done much to undermine public confidence in the vaccine, as have attempts to accommodate patient ‘choice’ by offering single vaccines as a substitute. A more confident official stance on vaccination would have been preferable. This is not to say that the public should be patronised in relation to the relevant research, or that exchanges between experts should be conducted in secrecy, but simply that the weight of established scientific evidence should be drawn upon in defence of a clear policy.

The fact that a directly coercive stance has not been adopted on multiple births, even given the new HFEA policy, is perhaps due to a second problem. In the case of the MMR vaccine, there is no upside to having measles, mumps or rubella, and no proven downside to receiving a vaccine to prevent these diseases. There is an upside to multiple births, however: namely children.

The statement that ‘there are significant risks to multiple pregnancies, and we should not be generating them deliberately’ refers to the ‘iatrogenic’ character of multiple pregnancy following multiple embryo transfer. But the term ‘iatrogenic’ may be misleading in this instance, because neither pregnancy (whether singleton or multiple) nor the absence of pregnancy is a disease. These things only become wanted or unwanted conditions in the context of individual needs and desires.

Implicit in the fact that IVF is (supposed to be) offered for free on the NHS is a good-faith assumption that the state should provide assistance to those who wish to have children. There may be conditions placed upon this provision – for example, a limit of three free cycles – in order to manage public expense. But there does not have to be a concomitant bad-faith assumption, that unless pregnancies brought about under the auspices of public health are of a defined type and exist within defined parameters, then patients risk acting against their own interests or those of their children.

Such details are best left to the discretion of the individual patient and the experts who treat them – or is such unregulated interaction between doctor and patient something the HFEA finds hard to conceive?

Sandy Starr is communications officer at the Progress Educational Trust, whose one-day conference Is the Embryo Sacrosanct? Multi-Faith Perspectives is taking place in East London on Wednesday 19 November. For further information, email sstarr@progress.org.uk.

(1) One child at a time: reducing multiple births after IVF (.pdf 480KB), Peter Braude, Expert Group on Multiple Births after IVF, October 2006, p23-29

(2) Code of Practice (1st Edition) (.pdf 4.85MB), Human Fertilisation and Embryology Authority, 1991, p38; HFEA embryo transfer policy review, Ruth Deech, Human Fertilisation and Embryology Authority, 3 August 2001; Code of Practice (6th Edition) (.pdf 582KB), Human Fertilisation and Embryology Authority, 2003, p83; One child at a time: reducing multiple births after IVF (.pdf 480KB), Peter Braude, Expert Group on Multiple Births after IVF, October 2006, p32

(3) The public health challenge of multiple births (.pdf 1.08MB), Alan Doran, Human Fertilisation and Embryology Authority, 24 January 2008; the One at a Time website

(4) Multiple births minimisation strategy (.pdf 14.9KB), (author?), Human Fertilisation and Embryology Authority, 30 September 2008, p1-2

(5) Stakeholder groups, on the One at a Time website; The best possible start to life (.pdf 3.96MB), Human Fertilisation and Embryology Authority, p17-18; Multiple births and single embryo transfer review: evidence base and policy analysis, Juliet Tizzard, Human Fertilisation and Embryology Authority, 17 October 2007, p13-14, 41

(6) Multiple births and single embryo transfer review: evidence base and policy analysis, Juliet Tizzard, Human Fertilisation and Embryology Authority, 17 October 2007, p15, 18

(7) Minutes of the non-confidential Authority meeting held on 17 October 2007 (.pdf 80.4KB), Human Fertilisation and Embryology Authority, 28 November 2007, p8

(8) Keith Reed quoted in Drive to cut number of IVF twins hampered by lack of NHS funding, Rebecca Smith, Daily Telegraph, 27 June 2008

(9) Fertility: assessment and treatment for people with fertility problems (.pdf 3.96MB), National Institute for Health and Clinical Excellence, 25 February 2004, p5, 24, 44; Primary care trust survey: provision of IVF in England 2007 (.pdf 55KB), Department of Health, 23 June 2008; Trusts ‘ignoring’ IVF guidelines, BBC News, 24 June 2008

(10) See, for example, Selective single blastocyst transfer reduces the multiple pregnancy rate and increases pregnancy rates: a pre- and post-intervention study (.pdf 123 KB), Yakoub Khalaf, Tarek El-Toukhy, Aravinthan Coomarasamy, Ahmed Kamal, Virginia Bolton and Peter Braude, British Journal of Obstetrics and Gynaecology, vol 115, no 3, February 2008, p385-390

(11) One child at a time: reducing multiple births after IVF (.pdf 480KB), Peter Braude, Expert Group on Multiple Births after IVF, October 2006, p32

(12) Norbert Gleicher quoted in Study on twinning contradicts worldwide consensus (.pdf 16.6 KB), Centre for Human Reproduction, 29 April 2008; Fertility experts critise new twin research, One at a Time, 8 July 2008