The subject of this year's Progress Educational Trust annual conference, entitled 'Reality Check', was 'a realistic look at assisted reproduction'. The choice of focus was motivated by ongoing controversy surrounding so-called 'IVF add-ons'. These are defined by the HFEA as 'optional extras that you may be offered on top of your normal fertility treatment, often at an additional cost'.
In addition, the general commercialisation of reproduction has become a frequent topic of conversation, not just among experts in the area, but also among patients who are often unsure of what or who to trust. At a time where public trust in experts is somewhat diminished, this conference set out to examine and analyse some of the reasons why and how this is happening.
Kicking off the day with the keynote lecture was Professor Soren Ziebe, who set out to ask the big question: what is a fertility doctor's duty?
Professor Ziebe began with a disclaimer to highlight that he heads a publicly funded IVF clinic in a country where free treatments are available, and, thus, for the purposes of this lecture, he believed he had no conflicts of interest. This disclaimer was poignant considering he, perhaps predictably, was fairly critical of the IVF 'industry' and some of the ways the HFEA regulates.
In his talk, Professor Ziebe argued that the 'do no harm' principle (nonmaleficence) so central to the medical ethical code should include financial harm, administrative harm and regulatory harm, in addition to physical and mental harm. This is an interesting concept and certainly one that warrants some thought and action.
In order to rate the reliability of add-ons, the HFEA has developed a traffic light system: 'red' indicates there is no evidence to show that the procedure is effective and safe, 'amber' is used where there is a small or conflicting body of evidence, and 'green' where there is positive data from more than one high quality Randomised Control Trial (RCT). Currently, there are six amber ratings, six red ratings and zero green ratings. Professor Ziebe argued that, given that there are zero treatment add-ons that are proven to work, perhaps they should stop being offered outside a trial and as an expense to the patients until there is demonstrable evidence of success.
To illustrate this, Professor Ziebe showed the average cost of an IVF cycle which also included ICSI (which is currently not classed as an add-on, although aspects of this are controversial and were discussed in a later session) versus IVF-related supplementary procedures (add-ons) and their prices.
Drawing on one of the supplementary procedures at random, Professor Ziebe showed that it is offered at nine out of twelve Danish private clinics, but at no public clinics. This adds to the mounting evidence suggesting that the provision of add-ons is financially-driven.
To limit patient confusion, Professor Ziebe suggested the HFEA traffic-light system is replaced by a binary one. To illustrate this suggestion, he outlined other areas where treatment lacking a proper evidence base would not be permitted; for example, it is not allowed to offer new medical drugs without evidence.
Patients choose add-ons out of fear of their ticking biological clocks, Professor Ziebe argued, choosing in their desperation to ignore the lack of evidence for their efficacy.
Professor Ziebe ended on a stirring note arguing that those, like him, working in assisted reproduction should have the highest professional standards. It is not possible to make decisions in the best interest of patients while at the same time trying to sell supplementary services. 'Patients trust us to guide them and this trust is a privilege we must treasure,' he said.
The lecture provoked interesting and impassioned discussion. Audience questions ranged from whether there should be sanctions against doctors who charge patients for add-ons where there is no scientific benefit, to why there is not better public engagement on the topic, to questions about the privatisation of infertility treatment. Professor Ziebe emphasised that he sees colleagues making a lot of money. There is a huge financial incentive for the provision of add-ons and the silencing of public discussion.
Overall, Professor Ziebe gave a provocative keynote and hopefully made clear to any private IVF doctors in the audience the need for proper, stringent regulation of this under-regulated area. I'm sure many will agree that it is outrageous to prey on vulnerable fertility patients for monetary gain, but that is what appears to be happening.
Worth a read, is a recent piece in the New York Times, which discusses this very topic, but from the patient's perspective. Notwithstanding that every patient is different and something that works for one individual may not work for another, one can see from this that there is much work to be done in educating the public about what works, and in helping them to make informed and evidence-based decisions about what treatment is right for them.
The Progress Educational Trust (PET) would like to thank the sponsors of its conference - the Anne McLaren Memorial Trust Fund, Edwards and Steptoe Research Trust Fund, CooperSurgical, the European Sperm Bank, Ferring Pharmaceuticals, the London Women's Clinic, NGA Law and the Institute of Medical Ethics.