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Preimplantation Genetic Diagnosis: The Who, the What, the Why and the How


 

IVF practices challenged: a response

05 December 2016

By Professor Adam Balen

Appeared in BioNews 880

The full version of this article is available at adambalen.com

This week IVF has been in the spotlight following the BBC Panorama programme 'Inside Britain's Fertility Business', which looked at 'add-ons' that some clinics offer. In my opinion, it was an example of extremely poor journalism, a misrepresentation of the majority of IVF units, and an amazing misunderstanding of the data. This sort of journalism serves only to frighten patients, who are already very anxious. It is of course right that fertility treatments are carefully scrutinised to make sure they are safe and effective. And we have a strict, yet permissive, regulator in the HFEA, as well as a large number of published guidelines and advisory papers by the National Institute for Health and Care Excellence (NICE), the Royal College of Obstetricians and Gynaecologists (RCOG) and the British Fertility Society (BFS).

The Panorama programme commissioned research by Professor Carl Heneghan and his team at the Centre for Evidence-Based Medicine at the University of Oxford, which was published open access by the BMJ. As chair of the BFS, I was approached several months ago by the Panorama team for an interview about add-ons. I asked to see the Heneghan study on which they based their programme, but they declined to send it to me. Nonetheless, I felt it important to be interviewed in order to be able to present a balanced overview of fertility practices in the UK and their regulation, and also to make the point that if there was better NHS funding of treatments, desperate couples would not be forced into the private sector. In the end, I was given less than 30 seconds air time and the programme offered no other official view from the sector. Furthermore, the HFEA had declined to be interviewed.

The BMJ paper suggests that many extra investigations and procedures alongside standard IVF treatment are not properly referenced on IVF centre websites and may not be evidence based. This is not necessarily a reflection of what is told to patients who attend those clinics, or of the written information that they may be given. Nonetheless, this is a wake-up call for us all to present clear, reliable and accurate data on our websites.

I felt very sorry for Dr George Ndukwe, of the Zita West clinic, who was filmed secretly by journalists posing as patients for the programme. I have no doubt that both he, Zita West and the rest of her team believe passionately in what they do and have the best interests of their patients at heart. Both the BFS and RCOG have written guidelines on immunology and have advised against the use of intralipid therapy (which appeared on three of the websites examined). Yet the undercover filming left a very bad taste, and it would have been much better to have interviewed Dr Ndukwe directly and to have given him the right to reply. 

As the BBC's flagship investigative programme, Panorama seriously let both itself and the BBC down. Throughout the programme, interviewer Dr Deborah Cohen, who works for the BMJ, repeatedly stated that '26 of the 27' add-ons cited in Heneghan's paper were not evidence based. To quote the BBC: 'Long-standing industry critic and fertility pioneer Professor Robert Winston told Panorama that he thinks most add-ons are unnecessary. "So many of them are not justified."' But I wonder how many of those who commented on this paper had actually read it? Forty-one items were looked at, and 27 were termed interventions. But the majority of websites did not contain 'add-ons' of concern.

Many of these so-called add-ons are in fact standard investigations and procedures that are required in certain circumstances. Unfortunately, every test and procedure has to be paid for, and some are essential for the proper treatment of patients. Again, if the NHS provided better funding this situation would not arise. Each individual clinic – whether NHS or private – has the freedom to choose what they include within their package of care, and then must budget appropriately.

Fertility interventions are based on the most up-to-date knowledge available, and there is a huge amount of peer-reviewed research taking place. IVF itself was not proven with randomised trials. In the 1970s, Bob Edwards and Patrick Steptoe tried the IVF technique for eight years before they were successful, and received almost no support from the medical research establishment. Even now it is very difficult to get funding for fertility research, despite the ground-breaking work here in the UK. Therefore, many of the evolving treatments find their way into clinical practice before they have been subjected to the full rigour of the clinical studies that we would ideally like. As long as we ensure that our patients are fully informed and not being harmed, we have to use the evidence available to keep exploring new ways to improve outcomes. On my website, I critically evaluate each of the add-ons cited in the BMJ paper.

The BMJ open access paper enables us to see the referees' reports. The first reviewer, Professor Cynthia Farquhar, co-chair of the Cochrane Steering Group, stated that: 'I am sure that this is no worse than other centres in Europe, the US and in Australia and NZ. The problem with the evidence in much of the literature is widespread confusion about the outcomes and the best way of reporting them. Many studies only report clinical pregnancy rate, which is inadequate for a number of reasons but mostly because of the difference from live birth rate.' She also went on to say that several Cochrane reviews were in progress for procedures mentioned in the programme, though it was hard to keep up with the pace that they are appearing.

The second reviewer, Dr Sue Avery, director of Birmingham Women's Fertility Centre, was spot on when she stated: 'Given the emotive nature of this treatment, there is considerable potential for exploitation, intentional or unintentional. The authors of this paper are aiming to address the quality of evidence associated with "add-ons", and to make suggestions as to how this problem could be addressed by the regulator. This is very welcome. However, the paper loses some of its power by including treatments that fall outside of the scope of add-ons.'

Dr Avery goes on to point out that the 'add-ons' listed included five interventions for which there may be some evidence of improvement in live birth rates, including intrauterine insemination in a natural cycle, which is an alternative treatment not usually applied to IVF patients. Likewise, ovulation induction and cycle monitoring is an entirely different treatment modality, while hysteroscopy is a diagnostic procedure. Numerous treatments which serve other practical purposes are also included in the list, such as ovarian tissue freezing and egg, embryo and sperm freezing (which are means of fertility preservation), and non-invasive prenatal screening.

Dr Avery concludes that the authors should have decided whether to include all procedures other than IVF for which centres charge a fee, or whether to stick to add-ons, specifically those for which claims of increased live birth rates are made. 'The message they seek to purvey is undoubtedly both important and sound when the argument is narrowed down. However, in its current form it could easily be dismissed by those it targets as having been written by those with no understanding of the field or the technology.'

In summary, in my opinion at least 20 of the so-called add-ons are either part of standard treatment or of potential benefit, and many of the others are being carefully evaluated in clinical trials. The Panorama programme repeatedly said that 26 out of 27 were of no value. They obviously did not feel the need to obtain clarification from any specialists in reproductive medicine, which significantly weakens the whole thrust of their argument and reflects extremely poor journalism. This is not to say that the world of IVF medicine has no room for improvement – of course it does. It is simply a question of providing a balanced appraisal of the evidence. 

If people would like to support infertile couples in accessing the very best treatments without breaking the bank, we strongly recommend campaigning for the NHS to observe the NICE guidelines in funding treatment. This is the real scandal in the world of infertility medicine.

SOURCES & REFERENCES
BMJ | 28 November 2016
 
BBC One | 28 November 2016
 

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