Fertility Watchdog Increasingly Concerned About Dubious treatments

The UK’s fertility watchdog is becoming “increasingly concerned” that private clinics are offering ‘add-on’ treatments which have not been properly tested to see if they actually work, it can be revealed.

In a series of interviews with The Independent, leading experts variously claimed some clinics were giving out “expensive, potentially harmful stuff like Smarties”, announcing breakthroughs that were closer to marketing “hype” and that half of the people treated did not actually need any help to have a baby.

A Cambridge university immunologist also said the use of immune-suppressant drugs by clinics was based on a flawed theory that this could help prevent miscarriage and broke the medical maxim to “first do no harm”.

Despite regular announcements of new techniques, progress has been relatively modest. In the 10 years to 2013, the average birth rate following IVF rose from about 20 per cent per cycle of treatment to 26.5 per cent.

After the Human Fertilisation & Embryology Authority was contacted about the experts’ concerns, the HFEA’s chair Sally Cheshire said it was planning to take action to help patients decide which techniques were worthwhile.

“Although the vast majority of clinics provide excellent care for fertility patients, we are becoming increasingly concerned about IVF treatment ‘add-ons’ without a strong evidence base being offered at some clinics,” she said in a statement.

“We know from talking to patients that they can find navigating the IVF process difficult and the offer of ‘add-ons’ can increase their confusion, and the cost of their treatment.

“Patients are often not sure whether they need the additional treatments but worry that they could regret not making every attempt they can to get pregnant.”

She said the HFEA was now working with scientists and the industry to “provide accurate and easy-to-understand information about these new treatments”.

One of Britain’s leading fertility experts, Yacoub Khalaf, director of the assisted conception unit of at Guy’s and St Thomas’ Hospital in London, stressed that some of those working in private fertility clinics were “very decent and honest people”.

But he added: “At best, patients are subject to exploitation; at worst, patients are being subjected to harm.

“All of this needs to be subjected to rigorous checks — and a reality check among the providers and the users.”

Mr Khalaf said some fertility clinic staff were simply putting “two and two together” about treatments that appeared to show signs of success without waiting for genuine scientific proof.

He said there might be a small number of patients who would benefit from such treatments, but this was “not a recipe to just dish out expensive, potentially harmful stuff like Smarties”.

“Some patients, through their use of expensive, unproven medication, could be deprived of the financial resilience to try again,” he added.

IVF treatment was developed in the 1960s by Sir Robert Edwards in work that later won him the Nobel Prize and one of his first graduate students was Martin Johnson.

Now emeritus professor of reproductive sciences at Cambridge University and joint senior editor of the journal Reproductive BioMedicine and Society, he pointed to “a lack of scientific rigour” behind some fertility clinic techniques.

“What it means is the treatment could be making their situation worse and certainly not improving it — and is costing them money. It’s all about anecdotal evidence or no objective evidence,” Professor Johnson said.

He said he felt the people doing it generally acted in “good faith”. “People can believe something that isn’t necessarily true. I would not describe it as a scandal. It’s over-enthusiastic clinics hyping some of their treatments more than they should do so,” he said.

But when asked if he had an “understanding” attitude towards their actions, Professor Johnson disagreed, saying: “I’m trying to think of explanations for why people, who are otherwise ethical, might do this.”

Dr John Parsons, founder and former director of King’s College Hospital’s assisted conception unit and a trustee of the Progress Education Trust fertility and genetics charity, has more than 30 years’ experience in the field.

Now semi-retired, he said he felt “very strongly that the industry – whatever you want to call us – has used whatever is to hand, regardless of whether it works or not, ever since I’ve been involved”.

“Every time there was a new, in inverted commas, ‘breakthrough’, it was tried on everybody and anybody,” said Dr Parsons.

“It’s got a bad smell about it. It’s all about the money. I worked in King’s College Hospital and was paid an NHS salary, but you get tainted by it. That was a pretty unpleasant feeling.

“I genuinely believe at least 50 per cent of the people who got pregnant didn’t need our help.”

Perhaps the most alarming technique is the use of drugs to suppress specialised immune cells in the mother’s uterus.

Cambridge University immunologist Professor Ashley Moffett said the idea that the foetus might be attacked by its mother’s body because half the unborn baby’s DNA comes from the father was first suggested by Nobel Prize winning biologist Sir Peter Brian Medawar, known as the “father of transplantation”.

“That’s a very attractive idea, but it’s actually not correct. But it’s become firmly embedded and it’s extremely hard to dislodge it, even among scientists,” Professor Moffett said.

“There’s certainly no evidence that it [immune-suppression] does any good and there is the potential that it can do harm because these treatments are immunosuppressive.

“Risking immunosuppression in someone who is young and fit is to me … first do no harm.”

She said one woman given immunosuppressant drugs by a private clinic became pregnant, but also seriously ill with a fungal infection. After the infection got into her bloodstream, she “lost the baby as a result quite late in the pregnancy”.

“I think these women are quite obviously, one understands, desperate, desperate and they will try anything,” Professor Moffett said, adding that their financial exploitation was “very sad”.

Professor Adam Balen, chair of the British Fertility Society, which speaks on behalf of the industry, said the most important thing was for patients to be given a genuine choice.

“Clinics have to be transparent and be open and provide appropriate information about exactly what it is they are offering and provide their own statistics as to the potential prospects of success,” he said.

“All of these treatments have been tested around the world and have been studied in clinical trials – every single one. None have been shown to do harm.”

Professor Balen, a reproductive medicine consultant at Leeds Teaching Hospitals NHS Trust, said exploring new techniques was also useful in driving up the success rate, which he said could be as high as 50 per cent for the best clinics.

“It is acceptable to provide certain treatments that may not have been conclusively shown to be absolutely beneficial to everybody, provided patients are informed,” he added.

Asked about critics of this idea, he said: “There are some people who are very outspoken and may have an axe to grind.”