"Can we trust everything" "Britain's multi-million pound fertility industry tells us?" "These are doctors, we believe what doctors tell us, and this is a doctor that holds my happiness in his hands." "BABY CRIES" "How effective are the treatments offered to thousands of couples by fertility doctors?" "So many of them are not justified." "It's just as simple as that, they're not justified." "Tonight on Panorama - we reveal major new research showing there's little good scientific evidence some of those treatments work." "It was one of the worst examples I've ever seen in health care." "I can't understand how this has been allowed to happen in the UK." "We go undercover inside one of the UK's top fertility clinics." "And we ask, should Britain's fertility patients be better protected?" "For about one in seven couples, infertility can be a private pain that takes over their lives." "Constant reminders, constant guilt, despair." "There is always someone telling me every week they're pregnant." "I felt guilty because I couldn't give my husband... the baby that I wanted to." "We got our babies, but I still feel like I'm an infertile woman," "I still have issues, and that'll never go away." "These people have all had fertility treatment, and they've been hit by the huge financial cost." "I just found this receipt and that was for 2,985." "I think we spent about 35,000." "We don't have oodles of money coming in and, I mean, we spent something like £45,000." "I've worked at medical journal the BMJ for a decade investigating the health industry." "IVF, where an egg and sperm are fused in a lab to try to make a baby, is an area of growing interest." "Over 50,000 women now have treatment annually." "You can get fertility treatment on the NHS, but what you can get depends on where you live." "So, around 60% of all fertility treatment is done in the private sector." "BABY GURGLES" "On average, one in four attempts results in a baby, and chances get lower with age." "So, clinics sell extras on top of IVF that are supposed to increase your chances." "They're known as add-ons." "There are dozens of different types of add-ons - you can put your embryos in special devices, pay for blood and genetic tests or even have extra drugs, but they don't always come cheap." "This way and point at things." "Look at them!" "Who's that?" "Kerry and Glyn Tomlinson have a little boy, Freddie." "He was conceived naturally, but only after a failed attempt at IVF on the NHS, and three unsuccessful attempts at a private clinic, costing £23,000." "Kerry's recipes show add-ons were a big part of the cost." "And I had to have three of those and that was for one." " So it's basically £1,000." " Yeah." "Yeah." "'The add-ons included test and treatments 'for problems with Kerry's immune system.'" "Their doctor said some people have high levels of immune cells that see an embryo as a foreign body so they attack it, stopping the pregnancy." "Initially I thought, you know," ""That sounds pretty serious,"" "because I didn't know" "I had anything wrong with me, but he said don't worry, he had treatment." "The add-on medicines would get rid of the extra immune cells or lower the chance of them attacking." "I came away thinking, "I'm with the right person here." ""This is going to work."" "At that time, there was no convincing evidence immune cells cause pregnancy failure, and little evidence to support the use of these add-on treatments." "Kerry and Glyn said their doctor didn't give them that impression." "We were being led to believe that" " this was giving us a greater chance." " Chance, yeah." "They were e-mailed a document saying these treatments were experimental." "It had a link to the relevant medical opinion saying they had little evidence, but they say face to face their doctor was positive about the treatments." "Doctors have a really important duty to their patients, they have to tell them about the benefits, harms and uncertainties of a treatment." "It's so patients can make the best possible decision." "It's what you call informed consent." "Recently, there's been further criticism of immune treatments." "The fertility regulator now says the theory behind them has been widely discredited." "So we decided to see what Kerry and Glyn's doctor would tell us." "He's the medical director at a clinic with a roll call of celebrity clients." "The Zita West Clinic in London." " WOMAN:" " Hi." " I'm George Ndukwe." "This is Dr George Ndukwe." "Two of our team are posing as a couple." "They tell him they've had three failed attempts with IVF in the past." "He wants to help them conceive." "He explains how problems with the immune system can stop you having a baby." "And he talks about specific cells in the immune system called natural killer cells." "We showed the footage to Professor Ashley Moffett." "She's spent her career studying natural killer cells." "She thinks their role has been misunderstood by some doctors." "Although they have been given the name "natural killer cells", they certainly don't kill the embryo, they're not even in contact with the embryo." "Dr Ndukwe wants to test our couple to find out if they have high natural killer cell levels or other problems that might prevent a pregnancy." "If they do, one suggestion is an add-on treatment - injections of a substance called Intralipid." "Intralipid is a mixture of egg yolk and soya oil." "It's a nutritional supplement, but here the idea is it will make the attacking cells less active." "It's very hard to understand how Intralipid came into use because there's absolutely no scientific rationale for using it at all." "But Dr Ndukwe believes Intralipid works." "He says one group of women who'd had six failed attempts at IVF saw a massive jump in their pregnancy rates compared to those who didn't use it." "A fivefold increase." "So, for a 9% chance of getting pregnant without using Intralipid to a 46% chance with it." "Experts say he's basing this on very low-quality research, there's no good scientific evidence Intralipid helps you have a baby." "Dr Ndukwe can prescribe it if he thinks it will help, but he should explain the lack of good evidence and he doesn't." "The couple are sent for a variety of blood tests." "The cost - £2,000." "But when it comes to those natural killer cells," "Dr Moffett says these test are irrelevant." "Blood is taken from the arm, but there are different types of natural killer cells or NK cells." "If you look at NK cells in the blood, they're quite different than NK cells in the uterus." "I don't think this will provide any helpful information for the doctor." "It's like if you wanted to measure the number of black cabs in Trafalgar Square, you do not measure the number of red minicabs on the M25." "Dr Ndukwe said these tests and treatments are only relevant to a minority of their patients." "His and other clinics' data strongly support the effectiveness of them for immune issues, helping hundreds of couples have babies when they'd failed elsewhere." "He said their pregnancy rates for women under 35 are more than 50% higher than the national average and validated independently." "They aim to give patients the information needed to make informed choices." "He said the Intralipid rates he quoted were not intended to predict the likelihood of success, many different factors are at work." "Add-ons are becoming a bigger part of the IVF business." "Lots of clinics make big claims about add-ons and say they'll increased your chance of success, but some critics say these claims are not backed up by good evidence." "Professor Robert Winston was one of the UK's pioneering fertility doctors." "He thinks most add-ons are unnecessary." "So many of them are not justified." "It's just as simple as that, they're not justified." "But they think they're giving the patient hope and, in my view, that's completely the wrong way to do this." "He says there's not good scientific evidence most add-ons improve your chances." "We need evidence-based medicine based on good, rational trials with that treatment." "They've not been done and until they are done," "I'm not prepared to accept that those treatment are necessary." "We wanted to find out how good the evidence is behind add-on treatments, so we approached Oxford University and the Centre for Evidence-Based Medicine." "The academics here are among the best in the world at assessing medical evidence." " Hi, Debs." " Hi, Carl." "Are you all right?" " Welcome." "They've spent a year researching it for us." "They've done a comprehensive study on the claims and evidence behind 27 add-on treatments." "Yeah, so, look." "Here's all the different ones here I can show you." "So, for instance..." "Professor Carl Heneghan's team started the way most patients do - researching online." "They found lots of positive claims for the add-ons on clinic website." "Here, for instance, it will make a statement," ""This allows the team to optimise your chance of achieving pregnancy."" "The team searched over 70 website in which they found almost 300 claims." "Carl Heneghan is shocked at how little evidence was quoted." "It was one of the worst examples" "I've ever seen in health care." "It's worse than all the advertising products." "The first thing you would expect to happen is anything that makes a claim for an intervention would be backed up by some evidence." "Cosmetics, they have to say, like, you know, "This product was tested on 100 women."" "Correct." "So they went looking for what evidence there is to see how far it shows these treatments boost your chances of having a baby." "Their results are surprising." "26 of the 27 don't have good scientific evidence they can increase your chances of a baby." "And there's a question mark over the evidence for the one that does." "So, you are saying only one had any evidence, or reasonable-quality evidence, of having any benefit on live births." "That is exactly what I'm saying." "Some of these treatments are of no benefit to you whatsoever and some of them are harmful." "I can't understand how this has been allowed to happen in the UK." "To be sure an add-on helps, the team says you need to do high-quality studies." "The best are randomised control trials, where patients are randomly assigned to groups and given a treatment or an alternative, like a placebo." "A randomised control trial is the most fair test we have over which treatment works best." "It's the gold standard." "We can be confident when we've done a randomised trial that, if something works, we've excluded all other explanations." "Before medicines are approved, they have to undergo large clinical trials, but many add-ons don't require the same high-quality level of evidence before use, so patients have to trust what their doctor tells them about the effects." "You look into, "What I can spend money on?" ""What can I research?" "What can we do to make this better?"" "To fix this problem." "You are in front of someone at the top of their field and they're telling you, "You need to try this." You know, as a layperson, you're not going to ask, "Well, where is your evidence?"" "I would have taken anything they offered me." "So, for me, it did." "It just made sense in my head." "Well-conducted trials matter because they can reveal problems with the treatment." "This Dutch scientist has concerns about one of the most expensive add-ons around." "This is our clean room, here we perform IVF." "The add-on involves screening embryos to check for abnormalities that might stop them implanting or miscarrying." "It's called preimplantation genetic screening or PGS." "It's not offered to patients in this Amsterdam clinic." "None of the centres in the Netherlands are offering PGS because we don't see any proof of the effectiveness of this technology." "In the UK and elsewhere, a version of PGS was offered for a decade before randomised trials were done." "Then Sebastiaan Mastenbroek did the first big trial and found it could reduce your chances of a baby." "PGS was a very promising technique." "It sounded very promising." "We found not only that it was not beneficial but it significantly lowered the pregnancy rates." "This was something we did not expect." "Clinics now offer new, more accurate versions of embryo screening or PGS." "Some charge up to £3,000." "Some initial research appears promising." "But they have not been shown yet, in robust trials, to improve your chances of a baby." "At the moment, PGS has not been shown to improve live-birth rate." "In the past, it has been shown to worsen outcomes." "You can pay for this privately tomorrow and it's going to cost you quite a few thousand pounds." "Until trials currently underway show otherwise, clinics are expected to tell patients that better evidence is needed." "You'd hope they'd tell you that up front, but how many do?" "It's November last year and I am at a fertility fair in London, where dozens of clinics from the UK and abroad pitch for new customers." "I choose 18 clinics at random." "I say I have been trying to get pregnant for a year and want IVF." "I ask if embryo screening, known as PGS, could be a helpful add-on." "Staff from a number of clinics appear positive." "I speak to 18 clinics." "Five suggest it could be helpful." "Eight say they'd only offer it to women over 40 or those who have had repeated IVF failures." "But there is no good scientific evidence it helps those women have a baby." "Only five give me the full picture." "Some think clinics should wait for the results of the current trials on PGS before offering it, in case, as with the first version, they show a negative effect." "I am actually surprised that again PGS, a costly procedure, is introduced into routine practice." "If anyone wants to offer it, they should at least acknowledge that there is no evidence substantiating the current claims." "It's been three weeks since our undercover couples saw" "Dr Ndukwe, when he suggested the add-on supplement" " Intralipid." "Our undercover couple have been sent this document about IVF from the clinic." "You would expect it to say Intralipid is unproven." "Except, it doesn't." "It says it's "investigational"." "But it's not clear what that means." "Now, our undercover couple is back for the results of their £2,000 blood tests for issues including natural killer cell levels." "Dr Ndukwe says this means they need treatment." "Among other things, he suggests two Intralipid infusions at nearly £200 a go and two more if they get pregnant." "I think it is very sad." "Because these women are being offered tests and therapies which are expensive." "For which there is no scientific rationale." "Dr Ndukwe should discuss the lack of good scientific evidence for Intralipid." "By the time he is asking the couple to sign a consent form, he still hasn't said anything." "Halfway down, it finally reveals Intralipid is unproven." " OK." " Thank you." " Pleasure." " Thanks a lot." "Our couple leave." "This barrister says this isn't good enough to inform them properly." "Dr Ndukwe needs to be equally clear about the pros and cons of an add-on he is selling." "Whether that is someone selling DIY material or a doctor offering a service in relation to IVF treatment - warts and all is the best approach." "And then you can argue that if your patient signs, they truly have had all the information to allow them to give informed consent." "Dr Ndukwe might be falling foul of consumer protection regulations." "I think a court may well conclude that what the doctor had done amounted to a misleading act under these regulations." "Dr Ndukwe said our experience was a one-off." "Patients are sent a document which..." "And links to contrary views in a paper." "We weren't sent it." "He says a part-time worker wasn't sufficiently familiar..." "The document saying Intralipid is investigational, now adds it's unproven." "But they'll conduct a..." "What I didn't realise, because we weren't told, is getting pregnant is actually quite hard." "Jessica Hepburn campaigns to ensure fertility patients are better informed." "She spent £70,000 on 11 failed attempts of fertility treatment at different clinics." "We remortgaged our house, we maxed-out the credit card, we borrowed money from family." "'You feel like you are not a proper woman, 'you can't do what every other woman seems to be able to do.'" "She says many patients feel powerless in consultations." "You don't want to complain or ask too many questions." "These are doctors." "We believe what doctors tell us." "And this is a doctor that holds my happiness in his hands." "Often, it's difficult to know what to believe about an add-on." "Some clinics make big claims about a special incubator." "It takes photos of embryos every few minutes, so clinics can watch them grow." "They say this helps them choose the best embryo." "And some charge hundreds of pounds to use it." "Trials have been done." "Together, they suggest there is not enough evidence it improves success rates over normal procedures." "The Oxford researchers question why patients are charged." "If you go for this system, it is no different to what is happening already." " Couples are charged for this." " Well, they shouldn't be." "It doesn't increase your chances of getting pregnant, OK?" "It doesn't even increase your chances of getting pregnant?" "No, it doesn't." "So, why would you charge for it?" "I'm off to find out, at Britain's biggest private clinic." " Now we can see it developing very fast." " Some clinics charge nothing." "Here it's an extra £775." "You have probably 300 images over a 24-hour period." "The clinic's done its own big study from its own patient results." "It's currently unpublished but they say it shows a big boost to patients' chances." "A sceptic might say," ""You would find that, your clinic charging over £700."" "We have invested in this." "We have studied it." "We believe it works." "We are offering it at a price because it is the only way we can offer it, we have to buy the equipment, train the staff." "And there is a price for that, like there is for anything." "The team at Oxford questions such research." "The clinic says it wouldn't offer the add-on if it didn't believe the results." "It says trials are often impractical." "Patients won't take part, they are very expensive, and they take too long to do." "Many of our patients do not have time." "If we evaluate it to the point where we believe we've got enough evidence to at least have a sensible discussion with a patient..." "It's unlikely to do you harm but it has a possibility of doing you benefit..." "Then I believe the patient has a right to make a decision." "And it's about the doctor giving the right information to the patient." "So, it's up to patients to decide." "But clinics need to inform them sufficiently." "I think it's our responsibility to ensure that couples have full information, provided we are not causing any harm," "I don't think there is any problem with giving patients information, discussing that we don't know yet but there is an evidence base developing." "It's a confusing area." "Patients might look to the fertility regulator - the Human Fertilisation and Embryology Authority - for help." "They license clinics and offer information for patients." "There is a sort of confusion because you think, "Well, this is the" ""Government regulator." "So they are licensing this clinic that is" ""offering a treatment that they say is unproven." ""But it can't be that bad, can it?" ""Because they are licensing that clinic."" "The regulator told us they have limited powers to stop clinics offering add-ons, or to control pricing." "They publish information for patients, so they can make informed decisions." "But shouldn't they be doing more?" "I think the HFEA has done a very bad job protecting patients." "I think it's done a very good job at insisting on high laboratory standards." "But they are scared of doing anything which might be seen as being beyond their remit." "The HFEA declined to be interviewed." "They admit they are concerned about the recent step change in the use of add-ons." "Next year, they will launch a website with more information about a wider range of add-ons." "But some might ignore their advice." "Most of these patients paid for add-ons even when they were told they're unproven." "If someone said, "If you cut off your hand, you will have a baby,"" "I think I would have done it!" "But I think also, with all these add-on treatments, it kept us going that there is still hope." "Fertility treatments need to be built on more than just hope." "They should be backed up by the strongest scientific evidence." "When that's not available, it's vital desperate patients can trust what their clinic tells them."