It’s been 40 years since the first human was born using in vitro fertilisation (IVF). A taboo for some, a fundamental right for others: when it comes to fertility, drawing an ethical framework is nearly impossible. Not least when it starts mingling with business opportunities.
The UK fertility market is estimated to be worth £320 million, which includes 68,000 IVF cycles carried out in 2017 alone. And up to 70 per cent of those were paid for privately, rather than offered on the NHS.
A growing market is usually the sign of a good economy – but in this case, it could also be one of not-so-well informed patients. In November, the Human Fertilisation and Embryology Authority (HFEA) released a statement expressing concern over the way IVF is sold in private clinics. Calling for the reestablishment of ethical practices, it specifically targeted the optional treatments, called add-ons, that clinics offer patients to improve chances of having a successful pregnancy.
With only a quarter of IVF cycles across all age groups resulting in a live birth, it is easy to see the appeal for couples of trying to boost their chances of pregnancy. Except there is no guarantee that add-ons will work.
Jessica Hepburn, the author of The Pursuit of Motherhood, went through 11 rounds of unsuccessful IVFs in private clinics, where she was offered – and purchased – add-on treatments. “Patients are partly complicit in this commercial relationship, because they are desperate and will try anything to make it work,” she says. “I do believe that every practitioner that offered me those add-ons did it from the real belief it might help.”
Yet the guidelines on treatments from the National Institute on Health and Care Excellence (Nice) are clear. Nice recognises 13 types of treatments that have sufficient evidence to be proven to work – that is, they have gone through enough randomised control trials to establish that they are effective in humans. Examples of treatments recommended by Nice include egg and embryo freezing, frozen embryo transfer or ovulation induction.
More importantly, 11 of those treatments are only recommended for patients with specific conditions. Surgical sperm extraction, for instance, is only justified for men with a low number of sperm – so it is rather pointless for a man with normal numbers of sperm to undergo a specific treatment to collect it.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, led a research project on the efficiency of IVF add-ons offered in UK clinics. His team found that a number of clinics are offering treatments to men and women who don’t have specific conditions, “when it is very clear that they should only be used for certain individuals,” he says. “That’s completely unnecessary. It is selling people false promises.”
Heneghan’s team also identified 25 other treatments offered to patients in the UK – treatments that are either not mentioned in Nice guidelines at all, or which still lack sufficient evidence through randomised control trials to prove that they are efficient.
Take assisted hatching, for example. This add-on procedure, which costs about £400, consists of using acid or lasers to make a hole in the zona pellucida – the layer of proteins that the embryo has to break to hatch in the womb. The treatment has been practiced since the late 1980s, supposedly to help the embryo break through the layer. Yet many studies agree that there is no proven beneficial effect that can be linked to the process.
And assisted hatching actually carries a risk of damaging the embryo. That is one of the reasons that HFEA signals it with a red colour code on its page about add-ons – red for “not proven to be effective and safe”.
Out of the nine treatments listed on the page by HFEA as the most common ones offered in clinics, four are red. The others are yellow – meaning the treatment has promising results but needs further research. As for the green colour code, you can keep looking. It still doesn’t exist.
For Heneghan, the fact that private clinics seemingly play on people’s vulnerability to increase revenue is the sign of a deeply flawed healthcare system. “What lets this industry flourish is uncertainty,” he says. “If people are not quite sure what works, they can be sold a lot of things. And you create a lot of work and economic growth, but you don’t fix the fundamental problem.” In its recent statement, HFEA also mentions how the “intensely competitive market” of privately funded IVF can undermine patient trust.
But if private clinics are gaining a reputation for selling expensive yet inefficient add-ons, how is it that they are still carrying out such a huge portion of IVF cycles in the UK? The Nice fertility guidelines, in fact, state that women under 40 should be offered up to three full cycles of IVF through the NHS. Only after that should couples resort to private healthcare.
But the reality is completely different. Nice only delivers guidelines; it is then up to local clinical commissioning groups (CCGs) to decide who can benefit from NHS-funded IVF procedures. In 2018, only 13 per cent of CCGs offered the three recommended cycles.
The reason for this often comes down to cost – seen as too high to pay for an intervention that has limited success rates. Only last year, for example, the London borough of Croydon became the first in the capital to deny access to IVF on the NHS. Croydon’s CCG justified the decision saying it would help save £836,000 per year.
Essentially, access to NHS-funded IVF heavily depends on financial decisions taken by local groups – something that has become known as “the postcode lottery”. Couples who are not lucky enough to live in an area where IVF is taken on by the state are forced to turn to private clinics.
Rebecca Brown, researcher in public health ethics at Oxford University, says that this is a fundamental social inequality. “Infertility is defined by the World Health Organisation as a disease,” she says. “Entitlement to treatment for a disease is based on your need for it, and the fact that you are a citizen of the country – not on your postcode.”
For Heneghan, the country needs a complete healthcare rethink. And as a researcher in evidence-based medicine, his approach is pretty straightforward. “When Nice says how many IVF cycles should be offered, the money should be made available to offer them nationally,” he says. “When it comes to add-ons, we should do the appropriate research, and when there is evidence that they work, the NHS should fund them. If they don’t work, we should get rid of them.”
In the meantime, he adds, transparency is key: when offered add-ons, patients should know exactly what they are paying for, especially if treatments are not backed by sufficient research. “It’s not going away, this issue,” he says. “Because you can sell a lot to someone who is vulnerable, if you tell them you can provide them with something to help them have a child”.
This article was originally published by WIRED UK
