Dr Simon Fishel and Catherine Bennett: Breeding Debate

Dear Catherine

Good news from the national institute for clinical excellence (Nice), which has issued draft proposals to establish a nationwide, consistent funding base for IVF through the NHS. If implemented, all couples who have tried to conceive for more than two years would have a right to three cycles of fertility treatment on the NHS. I appreciate there will be a considerable cost implication should the guidelines be implemented, not to mention the logistics of providing the service - new centres, training of new staff, contracting out etc. I know that there will be much debate and concern about the cash-strapped NHS, too. But I welcome the proposal.

Infertility is a medical condition. It is a health issue. Consider the WHO definition of Health: "A physical, mental and social issue and not simply related to disease or infirmity". All civilised countries recognise this when providing support in the realm of mental health for the mentally ill, for example. Yet infertility has been singularly, if not spectacularly, ignored as a health condition requiring an equitable nationwide NHS policy for too long.

Twenty-five years ago a treatment was developed - IVF - and through the intervening years it has been successfully honed and eventually accepted by mainstream medical practitioners the world over as an evidence-based option for a clinically untreatable condition. These latest guidelines add formal support to the acceptance of IVF, which seemed almost inconceivable when I started working in the field with Edwards and Steptoe, years before the first successful IVF birth, and when there was a general disapproval of the concept, let alone the technology.

When the first baby was born there was still much work to do to persuade the medical profession, not to mention the general public. Today it is a respected and accepted medical and scientific discipline.

I welcome the proposal most of all, however, for the many thousands of couples who until now have had the opportunity of access to a medical therapy denied them. Of course, there will still be rationing, but the principle that IVF is a part of the British health service, instead of the current "post code lottery", is a very important principle indeed.

No doubt there will be many detractors. Medicine's involvement with conception in our own species has stirred emotions for some quarter of a century. But I, for one, welcome the guidelines wholeheartedly.

Simon Fishel

Dear Simon

You are quite right. It is entirely proper that the opportunity to have a child by IVF should no longer be dictated by a person's wealth, or her proximity to a generous health authority. But the fact that Nice, hitherto a notoriously flinty body, has given its approval to a fantastically expensive treatment which, even now that it has been successfully honed, fails on average three-quarters of the time (and obviously much more often in the numerous clinics operating with a success rate of 16% or lower) must also give hope to many people suffering from less media-friendly health problems.

How, if IVF is to be publicly funded, can Nice reasonably continue to deny sufferers from severely debilitating and life-shortening diseases - such as colonic cancer, say - access to drugs it has previously rejected as not cost-effective or of dubious efficacy?

But renewed representations from hopeful patient groups will surely be as nothing compared with the difficulties Nice faces, if this proposal is adopted, in explaining exactly how equitable provision is to be achieved in the staggeringly erratic field of IVF. Even if it manages to sidestep questions of eligibility for NHS treatment - of the sort regularly smoothed over in autonomous private clinics happy to treat broody singletons - how can it enforce the egalitarian principle in a branch of medicine where the success rate currently varies from 39% to 10%?

Catherine

Dear Catherine

I have no doubt that the NHS will remain imperfect in that it will not be able to fund all levels of treatment (new equipment, new drugs, new surgical procedures etc) required for every existing and emerging condition. I accept that if there is no new or ring-fenced money, there is the risk of robbing Peter to pay Paul.

IVF is highly visible and much debated, but there are other contentious areas. The provisions for A&E, for example, are critical, and yet there are those who as a result of self-affliction cost the NHS millions - through drug addiction, alcohol abuse, dangerous driving etc. I am not arguing against treating such patients, simply recognising the potential for hypocritical reasoning. The argument of efficacy, too, is contentious throughout medicine. Some would argue the same point for certain cancers and the current use of chemo- and radiotherapy.

As already mentioned, infertility/childlessness affects a large part of the population. It is a serious condition, debilitating individuals for life, and is without question a health issue. The opportunity to ameliorate the condition should no longer remain unrecognised by our National Health Service.

I accept that there is indeed a pre-occupation with fertility (more often than not at the subconscious level) but it is not confined to the media. Fertility transcends culture, nationhood, religion. We might overlook the importance and effect on a single infertile couple, but consider the possibility that mankind awoke tomorrow to find not a single fertile individual on the planet. Then where would be the hope, the future, the meaning to life? This sounds dramatic at the global level, but the force of this is felt no less by individual couples.

As for the variance in IVF results, I agree. Funding should only be provided to those clinics that can deliver.

Simon

Dear Simon

I'm reassured by your belief that the alarming variations in the quality of IVF treatment would not be allowed, were the Nice proposals to be realised. (It would though be more heartening still if Nice itself had suggested as much).

In fact, one unintended benefit of NHS-funded IVF could be that the more buccaneering elements in the reproductive market finally find themselves subject to some sort of external control. Until now, neither peer-pressure nor the feeble wiggings of the (industry-funded) HFEA have been enough to prevent the continued licencing of establishments where the great majority of patients have about as much chance of a baby as they do of learning to fly.

The same easy tolerance has been extended to some extremely dubious clinical practices. I refer not only to the widespread deficiencies in conduct towards patients, who being dependably "desperate", will humbly accept any risk, pay any price and endure almost any slight from the God-like men who promise new life, but to the many extraordinary procedures and transactions which, in this arcane line of business, pass for routine. Such as "egg sharing", whereby poor young women are told it is a good idea to hand over half their eggs to richer, older women whose pregnancies will enhance the clinics' IVF success rates.

Even if Nice currently shows no interest in the ethics of, say, the use of unpredictable or actively risky fertility procedures - or in the continued, though discredited insistence on donor anonymity, the incidence of ovarian hyper-stimulation, the unknown quality of some genetic material, the referrals for "foetal reduction", the cavalier absence of proper health warnings - such practices must surely be more closely examined when the clinics responsible receive vast numbers of NHS patients.

Increased NHS engagement may be the only way to make the ambitious rivalry of the IVF business properly answerable for clinical behaviour, which, until now, often seems to have been decided by nothing more evidence-based than the individual prejudices of the ruling clinician. In this branch of medicine personalities have traditionally loomed larger than longitudinal studies. Their calling, you gather, is its own justification. It is far too exalted and much too urgent to be subjected to the finicky business of scholarly review.

In the Nice report, a wide variety of commonplace IVF interventions are excluded from future NHS funding on the basis that they are of no proven benefit. Indeed, as Nice blandly notes, en route to its approbatory conclusion, no random controlled trial exists that assesses the effectiveness of IVF treatment as against no treatment. It adds that there definitely ought to be a few. What do you think?

Catherine

Dear Catherine

It is of course important that any finalised proposal provides for administration/regulation to underscore the need for high standards. After all, by limiting treatment to below 40 years of age, the results ought to be in the higher range. I too hope Nice will consider this in their final recommendations.

As for your comments on "feeble wiggings of the (industry-funded) HFEA" and "dubious clinical practices", there is truth in what you say. When fertile couples try to conceive naturally they have about a one in four chance per cycle. Good IVF practice today can offer a one in three chance. Hence, we are now doing better that nature. However, it is all too easy for a practitioner to hide behind that fact, especially when they are consistently offering results at the lower - and unacceptable - end of the scale, or poor patient care.

But how do we assure best practice? I believe that this can only be obtained through appropriate training and regulation. Regulation has not been easy for the HFEA, which is - rightly - run by lay professionals who lack in-depth knowledge, and amongst whom there is a disrupting turnover of staff. The regulators need the support to obtain truly professional and proficient administrative and inspection teams. They are getting there, but sadly, and once again punitively for the patient, the cost of this is being borne in part by a levy - some say 'infertility tax' - on each patient's treatment cycle.

Our concern about some practitioner's conduct and the vulnerability of patients is a very important one. The best practitioners/clinics recognise the enormous cost - emotional as well as financial - of a treatment cycle to a couple who would rather be anywhere else on earth than going through IVF. Patients need all the sympathy and support, as well as most appropriate clinical management available. Things inevitably go wrong. It is how these are dealt with that is important.

One of the complaints I frequently hear is from those patients who are seen by "specialists" whose IVF practice is only a tiny fraction of their other busy clinical jobs (gynaecology, obstetrics, research and teaching, etc). Perhaps one way forward is to ensure that the senior and responsible practitioners are dedicated to IVF and their infertility patients.

I disagree with you about egg-sharing, though. At my organisation, Centres for Assisted Reproduction (Care), we were initially against egg-sharing when considering all the potential practical and persuasively emotive arguments. However, after spending a long time thinking this through with many colleagues, we have developed our own rules for offering the egg-sharing programme, which we believed could be beneficial to both recipients and the donor. Some years on, we are persuaded that it can be a "win-win" situation for recipient and donor. Yes, the pregnancy rates are high for both parties - and the patients would want that - and, managed properly, there has not been the negative connotation propounded by many antagonists. Indeed, it is a positive experience for most couples.

I certainly would not disagree with your concerns on patient welfare. Like you, I believe that both the patient and the unborn child must always remain of the utmost importance and concern to all practitioners and regulators.

The HFEA is indeed very much aware of this and is constantly reviewing its procedures to adapt, and the UK can indeed be proud of its record when comparing our regulation to that abroad. We must appreciate that the flip side to this is the occasional exposure of bad practice (from which all can learn). In the end, it is better to have such a system than one in which there is no regulation, potential unprofessional practice and hidden malpractice.

I believe that this country above all others should be prepared to take up new clinical initiatives and novel treatments. I have argued this for our novel and now licensed embryo-screening programme. Here, unlike many other countries, unless new treatments are taken up where the work can be audited (because each cycle is registered) and eventually analysed as beneficial or otherwise, we will never have access to this information that could be compared to the unaudited work going on in other countries. Vulnerable patients will always be exposed to the hype from clinics abroad and will be tempted to travel to distant parts of the planet to have a treatment of questionable benefit.

Simon

Dear Simon

Agreement! Up to a point. Supposing we disregard egg-sharing and "giving" - practices which, however nifty they may now appear, may well, I think, come to seem less straightforwardly benign when the third party to such deals gets to hear about his, or her origins. If, that is, the child is fortunate enough to be told the truth. An estimated 90% of parents of donor babies choose concealment, with the official connivance of the authorities.

Still, we agree that the HFEA in its current shape is unsatisfactory, and not merely, I think, because of its staff turnover, clinical ignorance, and its commercially compromised nature. Beyond totting up the clinics' figures, this supposedly regulatory body has negligible powers to regulate, either sternly or permissively. Which is why, every time the field of reproductive medicine - which certainly enjoys spectacular success in procreating news stories - is gripped by yet another scandal, or weird, Diane Blood/ancient mother-style dilemma, or possible revolutionary technical advance, the HFEA confesses that it is not in a position to do anything about this particular scandal, dilemma, or development. It is up to the courts, or the Department of Health, or the individual clinician. Even when the HFEA does try to use its initiative, attempting, for instance, to slow the galloping production of IVF triplets, resourceful clinics can simply ignore it.

In tolerating such clinical licence, the HFEA is merely enacting the wishes of its creator, the Warnock committee, whose 1984 report is now so desperately in need of a follow-up, that even Baroness Warnock has recently repudiated key passages.

Obviously the committee could not have foretold the way IVF would develop into an international trade, any more than it could have anticipated how soon we should witness the advent of cloning, tissue typing, egg freezing, internet sperm buying, Diane Blood, IVF doctor superheroes ... but now they are here, and if the coming, massively expanded, state-funded IVF programme is not to bring with it a similarly augmented number of IVF scandals and dramas, it will need the disinterested supervision of some more rigorous, and, as you say, more scientifically august regulatory body than the HFEA's collection of career executives.

The Nice guideline writers no doubt thought it was a brilliant wheeze to excuse themselves thinking about any of the social and ethical dilemmas that are now generally settled either by individual IVF clinicians or the courts. So who is going to do it? Such thinking is essential if the public is to get the best out of IVF, and be saved from the worst.

Catherine

Dr Simon Fishel is the director of CARE, the largest single provider of IVF in the UK (www.care-ivf.com)

Catherine Bennett is a Guardian columnist, and maker of the BBC documentary, The Baby Business