:00:08. > :00:12.Can we trust everything Britain's multimillion pound fertility
:00:13. > :00:15.industry tells us? These are doctors. We believe what doctors
:00:16. > :00:21.tell us. This is a doctor that holds my happiness in his hands. How
:00:22. > :00:26.effective are the treatments offered to thousands of couples by fertility
:00:27. > :00:31.doctors? So many of them are not justified. It's just as simple as
:00:32. > :00:35.that, they're not justified. Tonight on Panorama, we reveal major new
:00:36. > :00:40.research showing there's little good scientific evidence some of those
:00:41. > :00:43.treatments work. It was one of the worst examples I've ever seen in
:00:44. > :00:50.health care. I can't understand how this has been allowed to happen in
:00:51. > :01:00.the UK. We go under cover inside one of the UK's top fertility clinics.
:01:01. > :01:19.We ask: Should Britain's fertility patients be better protected?
:01:20. > :01:25.For about one in seven couples, infertility can be a private pain
:01:26. > :01:31.that takes over their lives. Constant reminders. Constant guilt,
:01:32. > :01:36.despair. There's always someone telling me every week they're
:01:37. > :01:42.pregnant. I feel guilty because I couldn't give my husband the baby
:01:43. > :01:47.that I wanted to. We got our babies, but I still feel like I'm an
:01:48. > :01:57.infertile woman. I still have issues. That will never go away.
:01:58. > :02:02.These people have all had fertility treatment. They've been hit by the
:02:03. > :02:12.huge financial cost. I just found this receipt and that was for
:02:13. > :02:13.?2,985. We spent about ?35,000. We don't have oodles of money coming
:02:14. > :02:30.in. We spent something like ?45,000. I've worked at medical journal the
:02:31. > :02:35.BMJ for a decade investigating the health industry. IVF, where an egg
:02:36. > :02:40.and sperm are fused in a lab to try and make a baby, is an area of
:02:41. > :02:44.growing interest. Over 50,000 women now have treatment annually. You can
:02:45. > :02:50.get fertility treatment on the NHS, but what you can get depends on
:02:51. > :02:51.where you live. So around 60% of all fertility treatment is done in the
:02:52. > :03:02.private sector. On average, one in four attempts
:03:03. > :03:08.results in a baby and chances get lower with age. Clinics sell extras
:03:09. > :03:16.on top of IVF, they're supposed to increase your chances. They're known
:03:17. > :03:20.as add-ones. -- add-ons. You can put your embryos in special devices, pay
:03:21. > :03:29.for blood and genetic tests or have extra drugs. They don't always come
:03:30. > :03:34.cheap. Kerry and Glyn Tomlinson have a little boy, Freddie. He was
:03:35. > :03:39.conceived naturally, but only after a failed attempt at IVF on the NHS.
:03:40. > :03:50.And three unsuccessful attempts at a private clinic. It cost ?23,000. IVF
:03:51. > :03:55.cycles, it's got everything... Kerry's receipts show add-ons were a
:03:56. > :04:01.big part of the cost. I had to have three of those, that was for one.
:04:02. > :04:05.It's basically ?1,000. Yeah, yeah. The add-ons included tests and
:04:06. > :04:10.treatments for problems with Kerry's immune system. Their doctor said
:04:11. > :04:14.some people have high levels of immune cells that see an embryo as a
:04:15. > :04:19.foreign body. So they attack it, stopping the pregnancy. Initially I
:04:20. > :04:23.thought, oh, that sounds pretty serious. I didn't know I had
:04:24. > :04:30.anything wrong with me. But he said, don't worry, he had treatment. The
:04:31. > :04:35.add-on medicines would get rid of the extra immune cells or lower the
:04:36. > :04:39.chance of them attack being.. I came away thinking, I'm with the right
:04:40. > :04:45.person here. This is going to work. At the time, there was no convincing
:04:46. > :04:48.evidence immune cells caused pregnancy failure and little
:04:49. > :04:52.evidence to support the use of the add-on treatments. Kerry and Glyn
:04:53. > :04:58.said their doctor didn't give thyme appreciation. We was being led to
:04:59. > :05:02.believe this was giving a greater chance. Yeah. They were e-mailed a
:05:03. > :05:05.document saying the treatments were experimental. It had a link to the
:05:06. > :05:10.relevant medical opinion saying they had little evidence. But they say
:05:11. > :05:14.face to face, their doctor was positive about the treatments.
:05:15. > :05:20.Doctors have a really important duty to their patients. They have to tell
:05:21. > :05:23.them about the benefits, harms and uncertainties of a treatment. It's
:05:24. > :05:32.so patients can make the best possible decision. It's what you
:05:33. > :05:36.call informed consent. Recently there's been further criticism of
:05:37. > :05:41.immune treatments. The fertility regulator now says the theory behind
:05:42. > :05:46.them has been widely discredited. So we decided to see what Kerry and
:05:47. > :05:49.Glyn's doctor would tell us. He's the medical director at a clinic
:05:50. > :06:01.with a roll call of celebrity clients. The Zita West Clinic in
:06:02. > :06:05.London. This is Dr George Ndukwe. Two of our team are posing as a
:06:06. > :06:08.couple. They tell him they've had three failed attempts with IVF in
:06:09. > :06:20.the past. He wants to help them conceive. He
:06:21. > :06:22.explains how problems with the immune system can stop you having a
:06:23. > :06:42.baby. And he talks about specific cells in
:06:43. > :07:00.the immune system called natural killer cells.
:07:01. > :07:08.We showed the footage to Professor Ashley Moffett. She's spent her
:07:09. > :07:15.career studying natural killer cells. They thinks their role has
:07:16. > :07:18.been misunderstood by some doctors. Although they have been given the
:07:19. > :07:21.name natural killer cells, they certainly don't kill the embryo.
:07:22. > :07:30.They're not even in contact with the embryo. Dr Ndukwe wants to test our
:07:31. > :07:33.couple to find out if they have high natural killer cell problems or
:07:34. > :07:41.other problems that might prevent a pregnancy. If they do, one
:07:42. > :07:51.suggestion is an add-on treatment, injections of a substance called
:07:52. > :07:59.intralipid. Intralipid is a mixture of egg yolk
:08:00. > :08:03.and soya oil. It's a nutritional supplement. Here, the idea is that
:08:04. > :08:07.it will make the attacking cells less active. It's hard to understand
:08:08. > :08:10.how intralipid came into use, because there's absolutely no
:08:11. > :08:19.scientific rationale for using it at all. But Dr Ndukwe believes
:08:20. > :08:24.intralipid works. He says one group of women, who'd had six failed
:08:25. > :08:29.attempts at IVF, saw a massive jump in their pregnancy rates compared to
:08:30. > :08:48.those who didn't use it. A five-fold increase.
:08:49. > :08:54.So, from a 9% chance of getting pregnant without using intralipid,
:08:55. > :09:16.to a 46% chance with it. Experts say he's basing this on very
:09:17. > :09:21.low quality research. There's no good scientific evidence intralipids
:09:22. > :09:25.help you have a baby. Dr Ndukwe can prescribe it if he thinks it could
:09:26. > :09:46.help. But he should explain the back of good evidence and he doesn't.
:09:47. > :09:59.The couple are sent for a variety of blood tests. The cost, ?2,000. When
:10:00. > :10:05.it comes to those natural killer cells, Dr Moffett says these tests
:10:06. > :10:09.are irrelevant. Blood is taken from the arm, but there are different
:10:10. > :10:14.types of natural killer cells or NK cells. If you look at NK cells in
:10:15. > :10:19.the blood, they're quite different than NK cells in the uterus. I don't
:10:20. > :10:26.think this will provide any helpful information for the doctor. It's
:10:27. > :10:30.like if you wanted to measure the number of black cabs in Trafalgar
:10:31. > :10:36.Square, you do not measure the number of red mini cabs on the M25.
:10:37. > :10:46.Dr Ndukwe said these tests and treats are only relevant to a
:10:47. > :10:55.minority of their patients. His and other clinics' data strongly support
:10:56. > :11:02.the effectiveness of them, helping hundreds of couples where others
:11:03. > :11:06.don't work. They aim to give patients the information needed to
:11:07. > :11:10.make informed choices. He said the intralipid rates he quoted were not
:11:11. > :11:16.intended to predict the likelihood of success, many different factors
:11:17. > :11:21.are at work. Add-ons are becoming a bigger part of the IVF business.
:11:22. > :11:24.Lots of clinics make big claims about add-ons and say they'll
:11:25. > :11:35.increase your chance of success, but some critics say these claims are
:11:36. > :11:38.not backed up by good evidence. Professor Robert Winston was unof
:11:39. > :11:45.the UK's pioneering fertility doctors. He thinks most add-ons are
:11:46. > :11:48.unnecessary. So many of them are not justified, it's just as simple as
:11:49. > :11:51.that. They're not justified. They think they're giving the patient
:11:52. > :11:56.hope. In my view, that's completely the wrong way to do this. They says
:11:57. > :12:03.there's not good scientific evidence most add-ons improve your chances.
:12:04. > :12:06.We need evidence-based medicine, based on good, rational trials with
:12:07. > :12:09.that treatment. They've not been done. Until they're done, I'm not
:12:10. > :12:17.prepared to accept that those treatments are necessary. We wanted
:12:18. > :12:21.to find out how good the evidence is behind add-on treatments. We
:12:22. > :12:25.approached Oxford University and the Centre for Evidence Based Medicine.
:12:26. > :12:32.The academics here are among the best in the world at assessing
:12:33. > :12:37.medical evidence. Welcome. They've spent a year researching it for us.
:12:38. > :12:42.They've done a comprehensive study on the claims and evidence behind 27
:12:43. > :12:47.add-on treatments. Here's all the different ones here, I can show you.
:12:48. > :12:51.Professor Carl Heneghan's team started the way most patients do,
:12:52. > :12:57.researching online. They found lots of positive claims for these add-ons
:12:58. > :13:02.on clinic websites. Here, for instance, it will make a statement,
:13:03. > :13:07.this allows a team to optimise your chance after chiefing the pregnancy.
:13:08. > :13:13.-- of achieving. The team searched over 70 websites in which they found
:13:14. > :13:19.almost 300 claims. Carl Heneghan is shocked at how little evidence was
:13:20. > :13:23.quoted. It was one of the worst examples I've ever seen in health
:13:24. > :13:25.care. It's worse than all the advertising products. The first
:13:26. > :13:29.thing you'd expect is that anything that makes a claim for an
:13:30. > :13:34.intervention would be backed up by some evidence. Cosmetics, they have
:13:35. > :13:40.to say, like, this product was tested on 100 women. Correct. So
:13:41. > :13:44.they went looking for what evidence there is to see how far it shows
:13:45. > :13:52.these treatments boost your chances of having a baby. Their results are
:13:53. > :13:56.surprising. 26 of the 27 don't have good scientific evidence they can
:13:57. > :14:02.increase your chances of a baby. And there's a question mark over the
:14:03. > :14:07.evidence for the one that does. So you are saying only one had any
:14:08. > :14:12.evidence or reasonable quality evidence of having any benefit on
:14:13. > :14:17.live births? That is exactly what I'm saying. Some of these treatments
:14:18. > :14:21.are of no benefit to you whatsoever. And some of them are harmful. I
:14:22. > :14:29.can't understand how this has been allowed to happen in the UK. To be
:14:30. > :14:35.sure an add-on helps the team says you need to do high quality studies.
:14:36. > :14:38.The best are randomised controlled trials, where patients are randomly
:14:39. > :14:45.assigned to groups and given a treatment or an alternative like a
:14:46. > :14:48.placebo. A trial is the most fair test we have over which treatment
:14:49. > :14:53.works best. It's the gold standard. We can be confident when we've done
:14:54. > :15:00.a randomised trial, if something works, we've excluded all other
:15:01. > :15:05.explanations. Before medicines are approved, they have to undergo large
:15:06. > :15:09.clinical trials. But many add-ons don't require the same high quality
:15:10. > :15:10.level of evidence before use. So patients have to trust what their
:15:11. > :15:22.doctor tells them about the effects. You look into what I can spend money
:15:23. > :15:29.on all research to make this better, fixed the problem. You have someone
:15:30. > :15:35.at the top of their field and they'd tell you you need to try this. As a
:15:36. > :15:42.layperson, you're not going to ask, where is your evidence? I would have
:15:43. > :15:51.taken anything offered. To me, it made sense in my head. Well
:15:52. > :15:56.conducted trials matter because they can reveal problems with the
:15:57. > :16:01.treatment. This Dutch scientist has concerns about one of the most
:16:02. > :16:06.expensive add-ons around. This is our clean room, where we perform
:16:07. > :16:14.IBF. It involves screening embryos to detect abnormalities which might
:16:15. > :16:23.prevent them implanting. It is called PGS, pre-implanting genetic
:16:24. > :16:30.screening. Nowhere in the Netherlands is offering PGS because
:16:31. > :16:35.we see no proof of this technology. In the UK and elsewhere, a version
:16:36. > :16:40.of PGS was offered for a decade before randomised trials work done.
:16:41. > :16:45.Then Ndukwe did the first trial and found it could reduce your chances
:16:46. > :16:53.of a baby. -- then Sebastiaan Mastenbroek. It sounded a very
:16:54. > :16:59.promising technique. It significantly lowered the pregnancy
:17:00. > :17:06.success. We did not expect that. More accurate versions are offered.
:17:07. > :17:12.Some charge up to ?3000. Some initial research appears promising.
:17:13. > :17:17.They have not been shown yet in robust trials to improve your
:17:18. > :17:23.chances of a baby. At the moment, PGS has not been shown to improve
:17:24. > :17:27.live birth rate. It has been shown to worsen outcomes. You can pay for
:17:28. > :17:35.this privately Tamara and it will cost a few thousand pounds. Until
:17:36. > :17:38.trials currently show otherwise, clinics are expected to tell
:17:39. > :17:44.patients better evidence is needed. You would hope they tell you that up
:17:45. > :17:48.front, but how many do? It is November last year and I am at a
:17:49. > :17:55.fertility fair in London where dozens of clinics from the UK and
:17:56. > :18:00.abroad pitch for new customers. I choose a team clinics at random. I
:18:01. > :18:06.say I have been trying to get pregnant for a year and want IVF. I
:18:07. > :18:13.ask if embryo screening, known as PGS, could be a helpful add-on. Are
:18:14. > :18:15.there good results with PGS? Start from a number of clinics appear
:18:16. > :18:54.positive. It is quite successful. I speak to 18 clinics. Five suggest
:18:55. > :19:00.it could be helpful. Eights say they would only offer it to women over 40
:19:01. > :19:04.or those who have had repeated IVF failures. There is no good
:19:05. > :19:06.scientific evidence it helps those women have a baby. Only five give me
:19:07. > :19:25.the full picture. Some think clinics should wait for
:19:26. > :19:30.the results of the current trials on PGS before offering it in case, as
:19:31. > :19:39.with the first version, they show a negative effect. I am actually
:19:40. > :19:43.surprised that again PGS, a costly procedure is introduced into routine
:19:44. > :19:47.practice. If anyone wants to offer it, they should at least acknowledge
:19:48. > :19:55.there is no evidence of Sanjay to the current claims. It has been
:19:56. > :19:59.three weeks since our undercover couples saw Doctor Ndukwe when he
:20:00. > :20:07.suggested the add-ons supplement, Intralipid. You would expect this
:20:08. > :20:13.document to say Intralipid is unproven. It does not. It says it is
:20:14. > :20:24.investigation. It is not clear what that means. Now, our undercover
:20:25. > :20:27.couple is back for the results of their ?2000 blood tests for issues
:20:28. > :20:40.including natural killer cell levels.
:20:41. > :20:48.Doctor Ndukwe says this means they need treatment. Among other things
:20:49. > :20:56.he suggests two Intralipid infusions at nearly 200 man they go -- ?200 a
:20:57. > :21:01.go and more if they get pregnant. I think it is very sad. These women
:21:02. > :21:07.are being offered tests and therapies which are expensive. There
:21:08. > :21:12.is no scientific rationale. Doctor Ndukwe should discuss the lack of
:21:13. > :21:15.good scientific evidence for Intralipid. By the time he is asking
:21:16. > :21:23.the couple to sign a consent form, he still has not said anything. Is
:21:24. > :21:31.there anything else we need to know or is it all in here?
:21:32. > :21:42.Halfway down, it finally reveals Intralipid is unproven. Our couple
:21:43. > :21:49.leave. This barrister says this is not good enough to inform them
:21:50. > :21:54.properly. Doctor Ndukwe needs to be equally clear about the pros and
:21:55. > :21:58.cons of an add-on he is selling. Whether it is summoned selling DIY
:21:59. > :22:03.material or a doctor offering a service in relation to IVF
:22:04. > :22:09.treatment. Warts and all is the best approach. Then you can argue that if
:22:10. > :22:15.you're patient signs, they truly have had all the information to
:22:16. > :22:21.allow them to give informed consent. Doctor Ndukwe might be falling foul
:22:22. > :22:28.of consumer protection legislation. A consumer court might well conclude
:22:29. > :22:34.that what the doctor had done was a misleading act under these wrecked
:22:35. > :22:40.relations. Doctor Ndukwe said the experience was a one-off. Patients
:22:41. > :22:45.are sent a document. We were not sent it. He's says a part-time
:22:46. > :22:53.worker was not sufficiently familiar with their routine. The document
:22:54. > :23:04.saying Intralipid is investigation on now says unproven.
:23:05. > :23:12.What I did not realise is getting pregnant is quite hard. Jessica
:23:13. > :23:17.Hepburn campaigns to ensure fertility patients are better
:23:18. > :23:22.informed. She spent ?70,000 on 11 failed attempts of fertility
:23:23. > :23:26.treatment at different clinics. We remortgage our house, maxed out our
:23:27. > :23:31.credit cards, borrowed money from family. You feel like you are not a
:23:32. > :23:38.proper woman, you cannot do what every other woman seems to be able
:23:39. > :23:43.to do. She says many patients feel powerless in consultations. You do
:23:44. > :23:48.not want to complain or ask too many questions. These are doctors. We
:23:49. > :23:55.believe what doctors tell us. This is a doctor who holds my happiness
:23:56. > :24:01.in his hands. Often, it is difficult to know what to believe about an
:24:02. > :24:06.add-on. Some clinics make big claims about the special incubator. It
:24:07. > :24:11.takes photos of embryos every few minutes so clinics can watch them
:24:12. > :24:16.grow. They say this helps them choose the best embryo. Some charge
:24:17. > :24:20.hundreds of pounds to use it. Trials have been done. Together, they
:24:21. > :24:27.suggest there is not enough evidence to prove success rates. Oxford
:24:28. > :24:35.research questions why patients are charged. It is no different to what
:24:36. > :24:39.is happening already. Couples are charged for this. They should not
:24:40. > :24:45.be. It does not increase your chances. It does not increase your
:24:46. > :24:53.chances of getting pregnant? No, it does not. So, why would you charge
:24:54. > :24:57.for it? I'm off to find at Britain's biggest private clinic. Now we can
:24:58. > :25:05.see it developing very fast. Some clinics charge nothing. Here it is
:25:06. > :25:11.an extra ?775. You have probably 300 images over a 24-hour period. The
:25:12. > :25:15.clinic has done its own big study from patient results. It is
:25:16. > :25:20.currently published but they say it shows a big boost to a patient's
:25:21. > :25:25.chances. Sceptics would say, you would find that because you are
:25:26. > :25:31.charging over ?700. We have invested in this. We have studied it. We
:25:32. > :25:35.believe it works. We are offering it at a price was we have to buy the
:25:36. > :25:40.equipment and train the staff. There is a price for that like anything.
:25:41. > :25:44.The team at Oxford questions such research. The clinic said it would
:25:45. > :25:49.not offer the add-on if it did not believe the results. It says trials
:25:50. > :25:53.are often impractical. Patients will not take part but they are often
:25:54. > :25:58.expensive and take too long to do. Many of our patients do not have
:25:59. > :26:02.time. If we evaluate it to the point where we believe we have enough
:26:03. > :26:08.evidence to at least have a sensible discussion with a patient, it is
:26:09. > :26:12.unlikely to do you harm but it has a possibility of doing new benefit,
:26:13. > :26:16.then I believe the patient has a right to make a decision. It is
:26:17. > :26:22.about the doctor giving the right information to the patient. It is up
:26:23. > :26:29.to patients to decide. Clinics need to inform them sufficiently. I think
:26:30. > :26:32.it is our responsibility to ensure that couples have full information,
:26:33. > :26:39.provided we are not causing any harm. I do not think there is any
:26:40. > :26:43.problem with giving patients information, discussing that we
:26:44. > :26:50.don't know yet but there is an evidence -based developing. It is a
:26:51. > :26:57.confusing area. Patients might look to the fertility regulator, the
:26:58. > :27:00.Human Fertilisation and Embryology Authority for help. They licensed
:27:01. > :27:07.clinics and offer information for patients. There is a sort of
:27:08. > :27:12.confusion because you think this is the Government regulator, said they
:27:13. > :27:16.are licensing this clinic that is offering a treatment they say is
:27:17. > :27:21.unproven. It cannot be that bad, can it? They are licensing that clinic.
:27:22. > :27:27.The regulator told us they have limited powers to stop clinics
:27:28. > :27:31.offering add-ons or to control pricing. They publish information
:27:32. > :27:39.for patients they can make informed decisions. Shouldn't they be doing
:27:40. > :27:43.more? I think the HFEA has done a bad job at protecting patients. The
:27:44. > :27:48.good job at insisting on high laboratory standards that bad at
:27:49. > :27:53.anything they might consider beyond their remit. The HFEA declined to be
:27:54. > :27:56.interviewed. They say they are concerned about the recent step
:27:57. > :28:02.change in the use of add-ons. Next year they will launch a website with
:28:03. > :28:07.more information about a wider range of add-ons. Some might ignore that
:28:08. > :28:12.advice. Most of these patients paid for add-ons even when they were told
:28:13. > :28:16.they were unproven. If someone said, if you cut of your hand, you will
:28:17. > :28:19.have a baby, I think I would have done it. With all these add-on
:28:20. > :28:27.treatments, it kept as going that there was still hope. Fertility
:28:28. > :28:31.treatments need to be built on more than just hope. They should be
:28:32. > :28:37.backed up by the strongest scientific evidence. When that is
:28:38. > :28:39.not available, it is vital desperate patients can trust what their clinic
:28:40. > :28:41.tells them.