More than six million people are alive thanks to IVF or in vitro fertilisation
The birth of the world’s first test tube baby, Louise Joy Brown, 40 years ago this week, was one of the 20th century’s most remarkable scientific advances.
More than six million people are alive thanks to the technique that made her birth possible — IVF or in vitro fertilisation, where a human egg is fertilised with sperm in a laboratory then implanted in the womb.
A great British success story, Louise was conceived in a feat of unparalleled scientific daring after more than ten years of research and 467 attempts to create human life outside the body.
Her arrival by Caesarean delivery at Oldham General Hospital on July 25, 1978, prompted an explosion of headlines worldwide — and huge controversy.
For some, it was the beginning of the end, the closest man could get to playing God, and the consequences would be dire, with the growth of ‘baby factories’ forecast.
The doctor and scientist who pioneered IVF — obstetrician and gynaecologist Patrick Steptoe and Cambridge physiologist Robert Edwards — were accused of dabbling with infanticide, creating ‘Frankenbabies’.
A spokesman for the Vatican later declared: ‘Without Edwards there wouldn’t be a market for eggs, or freezers full of embryos waiting to be transferred in utero (into the womb) or, more likely, to be used for research or to die, abandoned and forgotten by all.’
In 2010 Edwards, who died in 2013, was awarded the Nobel Prize in Physiology for his work, while Steptoe, who died ten years after his greatest achievement, is regarded as an immense pioneer.
But 40 years ago there were many who wanted him to be struck off the medical register. So what sort of man was he?
The Steptoe I knew when I was the Mail’s Medical Correspondent was the most unlikely medical revolutionary.
Tall and silver-haired, with soft blue eyes and a kind manner, he was passionate about his work and his patients.
For some the first IVF baby was the beginning of the end, the closest man could get to playing God, and the consequences would be dire, with the growth of ‘baby factories’ forecast
That passion was the armour he used to face down his detractors.
He’d seen too many women, and their partners, suffer the anguish of being unable to do what most of us take for granted: start a family.
In retrospect, what strikes me as remarkable is that, despite the hue and cry, how quickly this spectacular advance became a routine medical procedure.
In the 25 years following Louise’s birth, there were about 30,000 IVF babies born in the UK.
In 2016 alone, there were 20,028 births from 68,000 IVF treatments. (Infertility affects more than 3.5 million people in the UK — about one in seven couples.)
Louise Brown, the world’s first test tube baby, in her mother’s arms. She was born by IVF in 1978
While there is a postcode lottery in IVF treatment on the NHS (latest figures suggest just one in ten Clinical Commissioning Groups fund IVF for the full three cycles for women under 40 recommended by the National Institute for Health and Care Excellence), there is a booming market in private treatment.
According to the research consultancy LaingBuisson, the UK’s 132 licensed clinics were worth £320 million in total in 2016 and accounted for 68,000 IVF cycles and 13,500 intra uterine insemination (IUI) cycles. Demand is growing at about three per cent per year.
Which brings me to what I believe is the dark side of IVF — the commercialisation of this highly fraught procedure, fuelled by its incredible growth and the profits to be made.
Successful treatment undoubtedly brings great happiness, but IVF is also synonymous with a high failure rate.
There is the emotional trauma of successive treatment failures. The false hope it gives to women against whom the biological odds of conceiving are heavily stacked.
Then, of course, there are the crippling bills — and, increasingly, the speculative eye of the money men.
Private equity investment has driven much of the consolidation of the market since 2012, according to that LaingBuisson report.
It predicts NHS funding of IVF will fall as spending constraints tighten in a health system already struggling to cope with an ageing population. So, good news for private clinics, bad news for patients
According to a leading health economics consultant I spoke to, up to a third of the IVF market is controlled by private equity groups such as White Cloud, which owns the Fertility Partnership, and Bowmark, which owns Care Fertility.
Both are reputable clinics, but private equity groups’ prime responsibility, critics say, is to their investors not patients.
The consultant added: ‘I recently spoke to about 15 people who’ve been through IVF.
‘Typically they had a treatment estimate of about £4,000 but actually paid nearer £8,000 with supplementary charges.
‘Dentists risk being accused of professional misconduct if they don’t issue full treatment estimates. The same should be true with IVF.’
One group of clinics not shy of proclaiming its costs is Spanish chain IVI, which has a new centre in London.
This month, in what some see as the ultimate in the ‘commercialisation of reproduction’, it was revealed that it is offering ‘no baby, no fee’ deals that could cost up to £26,000 for three IVF cycles.
Given that private clinics typically charge up to £5,000 per treatment cycle and couples routinely have three or four cycles, IVI are charging well over the odds while making ambitious promises.
According to the marketing material: ‘With IVI Baby you will have your baby home with you in a maximum time frame of 24 months.’
This doesn’t quite fit with persistently low IVF success rates. Forty years after Louise Brown, the ‘take-home’ baby rate for IVF is less than 30 per cent among women under 35; about 15 per cent for women aged 38 to 39 and two per cent for women aged over 44.
The birth rate overall is 21 per cent, up from eight per cent in 1991. And what about the psychological toll?
Having IVF is an emotional roller-coaster as couples endure the agony of waiting to see if treatment has worked, while failure to conceive can be a devastating experience.
A major survey by Fertility Network UK and Middlesex University of couples having IVF found that 42 per cent of the 865 respondents had experienced suicidal feelings.
That is why NICE recommends counselling before, during and after treatment — regardless of outcome.
While the NHS offers women under 40 three IVF cycles, private clinics have not been slow to promote a 2015 report in the Journal of the American Medical Association that suggested around two-thirds of patients, especially women under 40, will be successful after six or more cycles of IVF.
This is despite the physical risks associated with the repeated use of the powerful drugs used to harvest eggs for IVF.
(There is no legal limit on the practice and concern is growing over the liberal use of the drugs, with some women who agree to share or donate eggs having treatment up to five times a year.)
Of course, the irony of IVF’s high failure rate is the opportunity it offers for boosting profits further through a range of ‘add-on’ treatments, costing up to £1,000 more, which claim to increase chances of conception, but some of which are highly dubious.
Complementary treatments such as homeopathy, which I believe are useless, are also in vogue.
This is something that concerns Ying Cheong, Professor of Reproductive Medicine at Southampton University.
‘With no scientific answers to explain the majority of the failures, many clinics resort to offering pointless, expensive add-ons to try to improve their success rate to no avail,’ she says.
Such add-ons inevitably feed the hope of desperate couples that the next cycle will be the one that works, and suppress any idea of stopping treatment and perhaps trying to come to terms with a childless future.
In her book, The Pursuit Of Motherhood, Jessica Hepburn told how that hope was so strong that IVF for her became ‘a habit, as addictive as crack cocaine, just as hard to kick and a hell of a lot more expensive.
If I had never been pregnant, I suspect I would have quit years ago. But I have conceived six times.
‘It’s just that, sadly, the pregnancies haven’t lasted. It’s those brief glimpses of hope that have fed my overwhelming compulsion to have ‘one last try’.’
Her craving for a baby cost her £50,000, but she was not an exceptionally big spender.
Ten per cent of respondents in a Fertility Network survey reported spending more than £30,000.
The Human Fertilisation and Embryology Authority (HFEA), is meant to protect vulnerable patients, but in 2016, Dr Fiona Godlee, editor of the British Medical Journal, highlighted a disturbing survey: of 27 add-on fertility treatments, most lacked evidence of effectiveness and information on possible risks.
‘Yet all are available, for a fee, to vulnerable people desperate to conceive a child,’ she wrote. The survey should be a ‘wake-up’ call for the HFEA, Dr Godlee added.
Indeed, the watchdog’s new website includes a traffic light system for add-on treatments: a green symbol means effective and safe; amber, promising results; and red, ‘no evidence of effectiveness and safety’.
Disturbingly, the nine ‘add-ons’ the HFEA lists are either red or amber — there are no greens.
The ‘reds’ include a controversial procedure called ‘assisted hatching’. Before an embryo can implant in the womb, it has to hatch from a shell-like structure. According to some specialists, a tiny surgical incision in the shell can trigger hatching.
But the HFEA maintains that this can damage the embryo, while NICE says the procedure is ‘not recommended because it has not been shown to improve pregnancy rates’.
Yet London clinics charge hundreds of pounds for assisted hatching — some twice as much as others.
The Centre for Reproductive and Genetic Health (CRGH) charges £600; London Women’s Clinic, £500; Fertility Plus, £400; Assisted Reproduction and Gynacology Centre, £300.
I asked CRGH how they justified charging for an unproven procedure and demanding £300 more than a rival.
Chief Operating Officer Jonathon Fagg did not comment on the cost, but insisted: ‘There is emerging evidence that, for a minority of patients with poor prognosis, assisted hatching can properly be offered.
‘We are entirely transparent about the evidence-base, the likelihood of success and the cost, so our patients can make an informed decision, supported and respected by our clinicians.’
Another procedure, ‘endometrial scratching’, in which the womb lining is scratched (apparently very painful, according to some women) in the belief it will aid embryo implantation, has an HFEA amber rating.
It advises that research has ‘consistently shown benefit’, but says more evidence is needed.
Well this month, evidence has been forthcoming — but not perhaps what proponents of the technique would have liked. In a study of 1,300 women in five countries, IVF success rates were virtually identical in women who had been ‘scratched’ and those who had not.
Four clinics I checked charge between £150 and £350 for ‘scratching’. Should they charge at all for unproven, potentially risky treatments? In my view, no, no and no again.
In its defence, the HFEA says it has been working with professional groups such as the British Fertility Society to decide how unproven technologies should be correctly introduced into clinical practice.
It adds that its updated Code of Practice, due out later this year, will require all clinics ‘to provide information about treatment add-ons to patients — including what evidence there is of effectiveness — and requiring them to point patients to the relevant sections of the HFEA website’.
In truth, the HFEA has no control over the Wild West of IVF charging structures because private clinics set their own fees.
Ironically, these fees could fall dramatically if IVF success rates improve, reducing the number of treatment cycles and the need for ‘add-ons’ and counselling.
This is the goal for Professor Evelyn Telfer and colleagues at Edinburgh University and doctors at the Royal Hospital for Sick Children in Edinburgh and the New York Center for Human Reproduction. They are researching what she calls ‘Second generation IVF’.
Her team is the first in the world to have grown human eggs — in a sliver of excised ovarian tissue — from the earliest stage to full maturity outside the body.
She, like test tube baby pioneers Steptoe and Edwards, has faced vehement criticism from colleagues because of the controversial nature of her research, in particular the fact that some of the developed eggs in her study matured in just 22 days compared with the five months it would have taken in the body.
‘The process takes much longer in the body because the eggs have to work in tandem with the woman’s hormonal cycle,’ explains Professor Telfer.
‘We describe the way our eggs grow outside the body not as accelerated development, but as development without brakes. That’s a big difference.’
She sees a future in which IVF is ‘streamlined’ by growing better quality eggs from ovarian tissue samples removed from a mother-to-be.
IVF patients would no longer need to suppress their natural menstrual cycle, take hormones to boost their egg supply or have eggs collected from their ovaries for every single treatment cycle, she says.
It would reduce the physical and emotional demands — and the costs.
Prof Telfer and her team are building on a tried and trusted technique in which ovarian tissue is taken from cancer patients and stored for future use once treatment — which can cause infertility — is over.
Of course, this involves invasive surgery but a one-off, day-case operation to remove just a few millimetres of ovarian tissue would probably harvest hundreds of eggs — many more than any one patient would ever need.
This exciting research would, I know, have thrilled Steptoe and Edwards. The cut-throat IVF marketplace that has grown up around their breakthrough and the exploitation of so many desperate couples by greedy investors would, however, appal them.
Prof Telfer is worried that her work is already attracting the speculative eye of money men who see laboratory grown human eggs as another lucrative business opportunity — despite the short term impact of reducing clinic fees as ‘take-home baby’ rates rise.
In the long term, potential for growth in this market is considerable in a developed world facing ageing populations and falling birth rates as women increasingly delay having children.
In Japan, if the birth rate does not start to rise, its population is predicted to fall from 128 million at present to 90 million by 2050, meaning that the country’s costs will have to be paid for by an ever-smaller proportion of its workforce.
Fertility treatments therefore may be a key to economic survival, boosting the birth rate by increasing the reproductive chances of more women in their 30s and 40s.
It is an alarming prospect and something, I am sure, that Steptoe and Edwards could never have envisaged that summer day 40 years ago when they introduced Louise Brown to the world.