Salvation through legislation?

Is a proposed bill to the UK parliament to defend the 'welfare of women' undergoing fertility treatment really the right way to address the debate over 'mild' and 'conventional' IVF? I raised my concerns over what I see as an unjustified backlash against conventional IVF in my BioNews commentary last month (see BioNews 973). I believe this is an effective treatment whose risks are being exaggerated, and whose benefits are being dismissed too easily in the media.

Dr Nargund and her colleagues last week began their response (BioNews 975) to my article by characterising their organisation (the International Society for Mild Approaches in Assisted Reproduction) as one that aims to promote the welfare of women undergoing fertility treatment. No one can argue with this as an objective, but I wonder whether a concern with welfare, however sincerely held, is sufficient to distinguish one professional body from all others.

After all, the reason we all practise medicine – not just in the realm of fertility – is to promote the welfare of patients who need treatment. Still, an explicit acknowledgement of the importance of the welfare of patients can only be a good thing. It is a different matter, however, to link patient welfare to a specific type of treatment, reified a priori above others.

Despite this reservation, I read the response of Dr Nargund and her colleagues with a great deal of interest. I have been interested in the complications of ovarian stimulation for most of my professional life. Nothing would make me happier than to see good evidence that mild IVF, however it may be defined, gives a similar likelihood of having a family for the majority of our patients as treatment involving higher doses of stimulation. Sadly, I do not find sufficient evidence in the article to convince me of this.

Interestingly, my colleagues quote the 'classic paper' by Valerie Baker in support of mild IVF. What this paper showed was that, for any given number of oocytes, women who achieved that number with a lower dose of follicle stimulating hormone had a higher likelihood of live birth than women who needed higher doses. To seize upon this as a justification of mild IVF is not justified. In fact, Baker and her co-authors, perhaps foreseeing such extrapolation, state in their very abstract that 'the results of this study do not justify the use of minimal-stimulation or natural-cycle IVF'.

With regard to outcomes of fresh IVF cycles, Dr Nargund and colleagues are right in so far as a limited number of studies (though by no means all) show similar fresh outcomes from mild and conventional IVF. But the question of cumulative live birth remains – and I am being generous here – open. With increasing efficiency of embryo freezing and transfer, this aspect of fertility treatment cannot be ignored.

As stated by Dr Nargund and colleagues, there is at present no large-scale randomised trial directly comparing mild with conventional IVF. I respectfully submit that such a trial would indeed be the place to start if they are keen to effect changes in clinical practice.

It is customary in medicine to rely upon hierarchies of evidence and rational persuasion. A resort to legislation to change ovarian stimulation protocols is, to say the least, unusual. I am not a legal expert, but this does not seem to be what the law is designed for. Clinicians should develop their practice by attending clinical conferences, not court, and reading medical sources – Human Reproduction, Fertility and Sterility and yes, BioNews, not Hansard! 

The question must arise – what is so uniquely poor about the practice of fertility clinicians in the UK that they need parliament to usurp the General Medical Council and remind them that they must take into account the welfare of the patient in front of them?

And, speaking of the welfare of women specifically, why should the legislation restrict itself to IVF? If we are to have a welfare of women bill, surely it should cover every aspect of women's health, rather than a treatment applicable to a fraction of women? What's more, legislation on the welfare of women would mean we are legislating for the welfare of women and children involved in IVF, while leaving men out of the picture entirely (which many of us feel happens enough in fertility treatment already).

What has the subfertile male done to be denied the protection my colleagues want the law to afford to his partner and offspring?

I do not intend this to be a reductio ad absurdum of the legislation, but this paradigm shift in managing clinical practice opens up all sorts of interesting avenues. For instance, does this not pave the way for parliamentary bills requiring cardiologists, liver surgeons and dermatologists take into account the welfare of their patients? If not, why not? 

With regard to Ovarian Hyperstimulation Syndrome (OHSS), we know that the risk goes up with increasing egg number above 15 or 20. But importantly, the biggest risk factor is pregnancy resulting from fresh embryo transfer. In any event, a complete picture can only be obtained through the use of absolute numbers.

The previous commentary states that 'OHSS is often presented to women as a "no pain, no gain" reality'. This is a classic straw man – as far as I understand it, literally no-one claims that OHSS is an essential part of IVF that women must put up with (in fact, no serious personal trainer will even say 'no pain, no gain' but that is another story). On the contrary, there are several examples in the media of OHSS risks being presented in an exaggerated and alarmist fashion. And these allegations can of course cause anxiety in women, thereby reducing their welfare.

I am however, in complete agreement with Dr Nargund and colleagues that 'the welfare of women in IVF is a wider concept beyond OHSS prevention'. This makes it even more important that we do not conflate entirely separate issues, which can be approached in several different ways to improve treatment safety, clinical practice and women's welfare.

I welcome the chance to discuss these different ways, but I would be surprised if legislation turns out to be one of them.