Dr Paul Soler gives his opinion on IVF (Sunday Times) - 28/6/2005

link to article in The TIMES

Infertility treatment: at what cost?
Dr Paul Soler

When I appeared on Bondiplus (TVM, June 7) dealing with in vitro fertilisation (IVF), my five-minute contribution stirred up the proverbial hornets' nest and led to the rapid mobilisation of the St James Hospital management leading to a full scale press conference.

The official purpose of the press conference (The Sunday Times, June 12) was to "clear any doubts" about IVF, to rebut "statements damaging to couples", and to allay fear in panic-stricken parents of "IVF children" about cancer and so forth.

Anybody with a modicum of common sense will realise that its real purpose was dual: first to serve as a new PR exercise and advertise their services; secondly to misquote and discredit all sources of opinion which are seen as a threat to their continuing business. The management even rallied carefully selected patients to play on the emotions of the public by recounting their past anguish and their present happiness and their satisfaction with the infinitely generous help and successful results of St James Hospital, all offered at unbeatable value for money.

To further consolidate this aim, on the Sunday night following the press conference, Dr Josie Muscat, director of St James Hospital, was the special guest on Professor Anglu Psaila's live radio programme. He also featured on Net TV a few days later. The management may have impressed some people about their long list of services and unverifiable success rates. But they have failed miserably to bully into silence the sources of opinion which they see as a threat.

Cost of treatment
In the aftermath of Bondiplus, I was taken to task and publicly "challenged" by the management of St James Hospital in its press conference about two points I raised. These points are two painful thorns in its side: the death rate of a sub-group of babies resulting from medical interventions such as assisted reproductive technology (ART), and the cost of infertility treatment. I will deal with the second one first and present some important facts.

On Bondiplus I expressed the fact that ART generates millions of pounds the world over. I was immediately pooh-poohed by Donald Felice, queried by Lou Bondý and came under direct fire by the man himself four days later. Whether infertility clinics in Malta are run at an unfair profit concerns me very little. That was not my point. ART clinics the world over compete by claiming the best "pregnancy success rates" at the cheapest prices. It's a very competitive market and it is a very lucrative business.

Dr Nigel Camilleri admitted on Bondiplus that he is spending thousands of pounds for IVF treatment. All the couples seeking ART know this. Some couples have admitted to me they have been financially ruined after undergoing a number of IVF cycles, and remain childless to this day. Allow me to quote (in translation) from the transcript what Dr Muscat has to say about the money issue when addressing the Parliamentary Committee on Social Affairs: "I estimate that with the interventions we carried out - I think today we have thousands of babies - with the system of artificial reproductive technology we have saved Maltese patients over Lm4 million (my italics). This money would otherwise have gone outside Malta, but instead remained in Malta and benefited nurses, surgeons and all those involved." Now even a secondary school student will be able to work out that at a 50 per cent cost saving, and that is a very high estimate, we are still talking of a turnover of "millions". The public can judge for itself. Now for the second point.

Inherent risks of multiple pregnancy
On issues relating to multiple pregnancy (twins, triplets, quadruplets, etc) resulting from ART interventions and the health risks these bring to newborn babies I have nothing to learn from Donald Felice or Mark Brincat, and least of all Josie Muscat. They may publicly deny what the medical literature in their speciality has to say on the subject (The Times, June 18).

They may consciously disregard my statements on Bondiplus about the very high mortality figures of this subgroup of babies in this country. They may knowingly disregard the concerns by medical experts from Sweden, The Netherlands and Britain about the health risks of older children conceived by IVF and label it all as nonsense ("hmerijiet"). They may conveniently measure "success" of their practice by "30 per cent pregnancy rates per IVF cycle". That is after all what they primarily aim to achieve. But paediatricians measure success differently: by the survival of a normal healthy child who will be cared for in a healthy, stable family environment, and by minimising the physical suffering of sick newborn babies. The public can judge which measure of success makes more medical and ethical sense.

This is the 21st century. ART and IVF technology have come a long way after 14 years of practice, and so we are told by the IVF experts. The truth is, IVF experts abroad admit that this "technology is a very imprecise science."

On Bondiplus I described what paediatricians in this country see only too often by recalling a scenario from 2004. The viewers heard how eight extremely small babies conceived by medical intervention, each weighing a few pounds and coming from two mothers, were admitted to the SCBU a few days apart. I stressed the dangerously crippling effects this had on the intensive care services of the entire country.

The public has taken the point. What the public did not hear was that three babies from one set of quads died. The smallest weighed 565 grams. Two died after 24 hours. One suffered prolonged agony from gangrene of her entire bowel. She passed away in front of her distraught parents who were by then overcome by the death of their two babies. The medical and nursing teams were similarly shaken, completely exhausted by then with the excessive workload.

These facts were witnessed by Mark Brincat as I personally showed him around the SCBU. The paediatric and nursing teams can verify this too. The fourth child survived thanks to the professionalism of all the team on the SCBU, plus a good dose of divine Providence. She was sent home to her parents after months in hospital. At least we saved one out of four babies for these parents.

This year so far, two sets of twins and a singleton baby (five in all), all conceived through ART, were admitted to the SCBU. One set of twins died from the complications of prematurity and low birth weight, and the singleton baby died from severe malformations. The other set of twins survived. For these two years the combined mortality figures for this subgroup of babies is at least five times higher than for naturally conceived singleton babies.

Five of these six deaths are not represented in official perinatal mortality statistics, which is why Donald Felice on Bondiplus conveniently recalled that Malta has the lowest perinatal mortality rate in the world.

Nevertheless, these are mortality figures that would make any responsible paediatrician or responsible healthcare provider shudder. The death of these babies has nothing to do with "weak genes" as Donald Felice would have us believe on Bondiplus. These deaths are not acceptable because the pregnancies are considered "high-risk" in obstetric jargon. At any rate it was medical intervention in the first place that made these pregnancies multiple and therefore "high-risk".

These very high mortality figures are due to the risks associated with multiple pregnancy, prematurity, low birth weight and IVF-related malformations. This has been acknowledged by responsible obstetricians, responsible fertility experts, responsible paediatricians and responsible health care providers for many years the world over. I am ready to back this up in front of any minister or competent authority in this country. An inquiry would be most welcome from my point of view, so long as it is made public.

For 2004 we can calculate the tens of thousands of liri to save the life of these tiny quadruplets. We can calculate the futile cost when a tiny baby dies. But we cannot calculate the cost of human suffering or anguish of these poor couples. This is unmeasurable and will not feature on official statistical records. But it is stuck for life in the memory of every paediatrician who cares for these sick babies and their parents.

This is what happens in countries when ART and IVF technology are practised without a regulating authority. Lou Bondý stated on his programme that we are "all in favour" of the need to regulate the practice of infertility clinics. I do not agree. The vast majority of doctors and many members of the public are in favour, yes, but a few are not: more about this later. What the law will say and how it will be enforced are, of course, separate and equally important issues.

Regulation in Britain
Our medical practice has very close ties with the UK. In Britain the treatment of human infertility is regulated by law and by the Human Fertilisation and Embryology Authority (HFEA). The HFEA in its code of practice instructs infertility clinics to routinely implant one embryo (two is allowed in exceptional cases) to reduce the risk of twins and triplets as "replacing more than two embryos does not increase the chances of having a baby but can substantially increase the risk of multiple birth," said Professor Ruth Deech, chairman of the HFEA (August 2001).

In its press statement on BBC the HFEA did not even refer to reducing the risk of quadruplets because it had been presumed that nobody in his right mind would expose mother and babies to such high risks.

Professor Templeton of the Royal College of Obstetrics and Gynaecology had this to say: "The aim of infertility treatment should be the delivery of a single healthy child (my italics), and several clinics here and abroad are now looking seriously at replacing only one embryo per transfer."

In the UK the transfer of more than two embryos per patient is frowned upon as unsafe clinical practice as it potentially endangers the life of the mother and her offspring. In the UK any infertility clinic in serious breach of the HFEA code of practice will be suspended or closed down, and the "person responsible" for such a clinic would be liable to be charged before the General Medical Council. This is how the public is protected in Britain. The Netherlands too are amending the regulations to allow only one embryo per transfer.

Regulation in Malta
So how is the public protected in Malta? No law or authority has regulated this practice for the past 18 years. For 18 years the operators of infertility clinics have been practising in the confines of their private clinics without regulation. But the public is assured by Dr Muscat on TV that he is not a "cowboy" (sic). Cowboys work long hours too but the only ART they are allowed to practise is on cows, at least in USA. And I can bet my bottom dollar that they need a license for this. Secondly, in The Sunday Times (June 12) he is reported as saying that his clinic drew up its own standards.

Are the management of St James Hospital and the medical professionals involved in the practice of infertility in favour of legislation and regulation? Dr Muscat is assuring the public he is "not against" regulation. The negative statement stands out and his transcript says: "But we are quite concerned that the regulations certain people are talking about would be many other regulations which serve only to hinder advances in medicine".

Professor Brincat entirely agrees with this. He argues that his field of specialisation is no different from say, cardiology, and since cardiology is not regulated why should his specialty be treated differently? This is seen as a form of persecution as that practised against the genius Galileo. Professor Brincat goes on to say that in Malta there are no brains competent enough to legislate and regulate effectively his area of expertise. He is asking for foreign experts to be brought in for the purpose. Are we to believe that the Maltese are all a bunch of morons? (I refer the reader to his transcribed exposition to the Parliamentary Committee). The public can now judge for itself which members of the medical profession are "against" or "not against" regulation. And the public can also judge whether in cowboy country the level of protection it has been given these past 18 years is truly deserving or not. I rest my case.

Final appeal
I humbly appeal to the Parliamentary Committee for Social Affairs to steer well away from the premise that medical science is supreme. In Parliament and the media we have heard exponents of this ideology saying and that in the practice of medicine the end result justifies any means of achieving it. Doctors need not ask questions about moral ethics. That's for the moralists. After all the moralists disagree among themselves and medicine cannot wait. Doctors are busy people and they have to earn their living too.

Any regulation which restricts the work of medical scientists is labelled as outdated, Church-influenced and "fundamentalist", "against advance in medicine".

This is a very dangerous premise, especially when coming from doctors entrusted with the life of born and unborn persons. Modern history is testimony to this. History also teaches us that for evil to prevail, it is enough for good men to do nothing.

Medical science is at the service of mankind and all regulation must first and foremost safeguard the dignity of human life and the best interests of the public. Regulation must safeguard the best interests of infertile couples in their often desperate bid to have children. It must safeguard them against exploitation by profiteering charlatans who advertise themselves as specialists while dismissing prenatal professional counselling as a luxury they cannot afford.

Regulation must ensure that infertility treatment is not only an option for wealthy couples, but for all those truly deserving of infertility treatment of the highest standard. Regulation must safeguard the health of all unborn children and ensure that long-term health surveillance for this sub-group of children is provided by the Health Department.

The Committee must do all this, and more, in the light of the traditional Christian values of our nation if it is to serve the public in the manner it truly deserves. The fame and fortune of a handful of scientists and medical doctors must come last on the priority list.

I am sure this article will unleash further wrath from the experts and they will kick hard and mercilessly. The two thorns are now stuck ever so deep in their thick hide. They will have great difficulty extracting them since the truth speaks for itself.

But what if, before legislation hopefully regulates them, they decide to clone themselves by the thousand in an attempt to swing public opinion in their favour and swamp out all opposition? No, surely this cannot happen; it's just a bad dream! Anyway, by the time their clones grow up the public will know more of the truth... and that's a promise!

Dr Paul Soler, MD, MRCP (UK), MRCPCH, is a consultant neonatal paediatrician, president of the Maltese Paediatric Association and member of the Medical Council

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