28/02/2012

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:00:09. > :00:15.Here we go again. First it was breasts, now implants routinely

:00:15. > :00:21.used by the NHS for hip replacements, may be leaking metal

:00:21. > :00:26.fragments into their hosts. 49,000 British patients with all-

:00:26. > :00:32.metal hip replacements will have to be monitored for life, with a view

:00:32. > :00:36.to taking them out again. I'm glad we got there in time, metal debris,

:00:36. > :00:39.front wall of the pelvis has been eaten away. I will be asking the

:00:39. > :00:42.regulator, who is supposed to keep us safe, how on earth this could

:00:42. > :00:46.have happened. He's the pizza millionaire who

:00:46. > :00:53.claimed he could deliver the White House for the Republican party, and

:00:54. > :01:02.found, he couldn't. Becoming President was Plan A, and before

:01:02. > :01:07.you get discouraged, today I want to describe Plan B. We will ask

:01:07. > :01:10.Herman Cain what Plan B is. Britain's biggest cake shop chain

:01:10. > :01:15.is the latest to query the ingredients of the Government's

:01:15. > :01:20.work experience scheme. Also tonight:

:01:20. > :01:25.In the City they call Barclays Bank the bald eagle, now the Treasury

:01:25. > :01:35.has decided to clawback the money from a perfectly legal tax dodge.

:01:35. > :01:36.

:01:36. > :01:41.What other retrospective laws might they try out?

:01:41. > :01:46.We have given lots of people a new lease of life, seeming to free them

:01:46. > :01:50.from infirmity and pain. Tonight the regulator is saying anyone with

:01:51. > :01:54.an all-metal hip joint should undergo tests every year for as

:01:54. > :01:57.long as they have it inside them. Following an investigation by this

:01:57. > :02:00.programme and the British Medical Journal, which has uncovered

:02:01. > :02:07.serious side-effects in some people, and raises profound questions about

:02:07. > :02:14.whether this sort of surgery is properly regulated.

:02:14. > :02:20.Replacing a hip is about as physical as it gets for a surgeon.

:02:20. > :02:24.But as tough as the operation is, around 70,000 people a year have

:02:24. > :02:30.hip replacements. For most people this is life changing.

:02:30. > :02:34.Taking away years of pain and disability, but for some, there can

:02:34. > :02:38.be a down side. Surgeries are concerned that some

:02:38. > :02:42.metal hips are wearing down faster than they should. There are fears

:02:42. > :02:47.that metal debris from the joint is poisoning patients. Around 2,000

:02:48. > :02:54.patients a year are having to have their metal hips replaced.

:02:54. > :02:59.The UK regulator, the MHRA, announced that 49,000 patients,

:02:59. > :03:02.with all-metal, total hip replacements, like this one, with a

:03:02. > :03:06.large diameter, will have to have annual checks because of safety

:03:06. > :03:11.fears. Particles of metal debris have destroyed tissue around the

:03:11. > :03:16.joipbts in thousands of patients, we understand on Thursday, research

:03:16. > :03:19.will be presented looking at the risks of bladder cancer in these

:03:19. > :03:23.patients. No clinical trials were done before these hips were put in.

:03:23. > :03:27.One campaigning group is calling it a large, uncontrolled experiment,

:03:27. > :03:34.involving millions of patients around the world. Following on from

:03:34. > :03:37.the breast implants scandal, experts say the whole system, for

:03:38. > :03:41.regulating devices, is not protecting the public. Maureen

:03:41. > :03:46.laughed walking in the Yorkshire Dales near her home in Richmond. It

:03:46. > :03:49.was a surprise when the surgeon told her she needed to have two hip

:03:49. > :03:54.replacements. When I went to the hospital I was told I would get

:03:54. > :03:59.this new kind of hip joint, a state-of-the-art joint, it was

:03:59. > :04:05.metal and would last almost probably my lifetime. Maureen had

:04:05. > :04:09.two Pinnacle hips put in, they are mind by US giant, Johnson & Johnson.

:04:09. > :04:14.They were fitted in 2005, they have already failed. I have swelling in

:04:14. > :04:19.my lower abdomen, I had an ultra sound, and they said they are fluid,

:04:19. > :04:24.but obviously they shouldn't be there. They do concern me, lumps in

:04:24. > :04:29.my body, you don't want them. Nagel is Maureen's surgeon, he's

:04:29. > :04:34.about to replace one of her failed implants. There is nearly no other

:04:34. > :04:41.explanation, apart from the implant is wearing out abnormally. I'm glad

:04:41. > :04:46.we have got here in time. Metal debris everywhere. The front wall

:04:46. > :04:50.of the pel is -- pelvis has just been eaten away. But it really is

:04:50. > :04:56.quite significant the damage. is scooping out a mixture of

:04:56. > :05:00.rotting flesh and cobalt and chromium metal debris from around

:05:00. > :05:05.Maureen's hip joint. Surgeries are worried about the levels of these

:05:05. > :05:12.metals in patients' blood, because of the possible long-term damage to

:05:12. > :05:18.health. We are seeing patients of 10, 20, 50-times normal levels, the

:05:18. > :05:22.highest level is to nearly 300. Tony has removed the head of

:05:22. > :05:25.Maureen's hip implant, and it is clearly damaged. That is where the

:05:25. > :05:31.wear starts, and it goes right down to the floor. That is the wornout

:05:31. > :05:35.part, it goes right the way round. This is mechanical wear, that is

:05:35. > :05:38.the problems you get with mechanical. Maureen's hip has now

:05:38. > :05:42.been sent to experts at Newcastle University, this is one of several

:05:42. > :05:49.centres around the country trying to figure out what is going wrong,

:05:49. > :05:54.let's see what they find. Maureen's hip joint is put on to a scanner

:05:54. > :05:58.which maps the damage. Mechanical engineers then analyse how much

:05:58. > :06:05.metal has worn away. We can see damage from the head, we can also

:06:05. > :06:08.see damage from the metal cup. So whether we have metal surfaces in

:06:08. > :06:14.contact, potentially that can generate metal wear that will go

:06:14. > :06:20.inside the patient. Tom Joyce is an engineer, who has analysed hundreds

:06:20. > :06:23.of tip joints. There is evidence that these large metal-on-metal

:06:23. > :06:27.hips are failing at a rate we wouldn't expect. We are trying to

:06:27. > :06:33.get the bottom of that and explain what is happening. Surgeries

:06:33. > :06:36.decided to use metal-on-metal hips, because old versions, made of

:06:36. > :06:42.plastic, were wearing down in active people. They thought metal

:06:42. > :06:46.would be a more durable option. Some times of metal hips work well

:06:46. > :06:51.in young, active men. How have these failing metal hips been

:06:51. > :06:55.allowed to get on to the market? The scandal of PIP's breast

:06:55. > :07:02.implants, expose the failure of regulators to protect patients and

:07:02. > :07:06.cause a public outcry. The same failure of regulation has led to

:07:06. > :07:11.thousands of patients needing their hips replaced. It is a long, costly

:07:11. > :07:14.process to get drugs on to the markets. They have to be tested in

:07:14. > :07:17.test-tubes, animals and large clinical trials by people, before

:07:17. > :07:21.they are used on you and me. You would think it is the same for

:07:21. > :07:25.artificial breast and hip implant, but it is not. Doctors are

:07:25. > :07:29.concerned there is not enough regulation to stop harmful devices

:07:29. > :07:35.being put into hates. Carl Henegan has studied the way medal devices

:07:35. > :07:39.are regulated in Europe. We realise with drugs like thalidomide we

:07:39. > :07:43.can't carry on with the current system, it is catastrophic. The

:07:43. > :07:47.data can be eight to ten years of development and drug trial, then

:07:47. > :07:52.you have to have on going trials for safety and efficacy. With

:07:52. > :07:56.devices it couldn't be more different. My estimate is you could

:07:56. > :07:59.get a device through with a two to three day literature review, and no

:07:59. > :08:04.clinical data requirements at the current time. You are telling me

:08:04. > :08:09.you could get a hip to market with two to three days work looking at

:08:09. > :08:14.the literature? Yes, and 7 0hips have gone through the system in the

:08:14. > :08:17.US, only three have clinical data, that is in the world. If you want a

:08:17. > :08:21.new drug on to the market in Europe, you have to go to a central

:08:21. > :08:24.regulator to get approval. But for a new, artificial hip or breast

:08:24. > :08:29.implant, the manufacturers can choose who they want to approve it.

:08:29. > :08:37.They can go to any of dozens of companies who are all competing for

:08:37. > :08:42.their business. DePuy use the British standards institution,

:08:42. > :08:46.which is better known for giving Kite Marks to such things as

:08:46. > :08:50.toasters and baby buggies. DePuy wouldn't tell us what tests they

:08:50. > :09:00.had done on artificial hips because of client confidentiality. They

:09:00. > :09:01.

:09:01. > :09:07.Governments around the world have been very lapse in checking the

:09:07. > :09:11.implants. An e-mail from a senior manager at DePuy and says it is a

:09:11. > :09:16."fun fact" that in South Africa you could implant a tent rod if you

:09:16. > :09:20.wanted to. It is astonishing that DePuy could tweak the design

:09:20. > :09:25.without testing how it works with patients. The head became bigger

:09:25. > :09:31.and the stem shorter. The head of the MHRA has known since 2006 that

:09:31. > :09:37.there were concerns about the hips. The data tells us since 2006 that

:09:37. > :09:45.there were metal lines being -- increases in the replacements.

:09:45. > :09:49.There was enough data to make the certain in 2006. As early as 2005,

:09:49. > :09:54.internal DePuy documents show they were aware of the damage that could

:09:54. > :10:00.be done to patients for metal-on- metal implants. They are being sued

:10:00. > :10:03.by patients who have had to of the hips replaced. They have put

:10:03. > :10:07.millions aside to cover potential costs.

:10:07. > :10:11.Tony Nagel is an expert witness in the legal case against DePuy.

:10:11. > :10:17.Originally he was paid by the company to train surgeries in the

:10:17. > :10:21.use of their implants. Now his hospital trust has recalled call

:10:21. > :10:26.patients with metal-on-metal hips. We have brought back all the

:10:26. > :10:31.patients with Pinnacle caps, nearly 1 though, tested, screened them and

:10:31. > :10:37.scanned them, we know exactly what is happening. We have out of 970

:10:37. > :10:41.patients, 75 failures related to metal debris, that is high. DePuy

:10:41. > :10:46.told Newsnight and the BMJ, that patient safety is their top

:10:46. > :10:56.priority, and clinical data showed the Pinnacle was safe. Tony Nagel

:10:56. > :10:56.

:10:56. > :11:06.first told the company about damage to tissue in Pinnacle in 2008?

:11:06. > :11:10.

:11:10. > :11:17.But the metal-on-metal Pinnacle is still on sale. The UK regulator,

:11:17. > :11:22.the MHRA appointed a committee to decide the fate of metal-on-metal

:11:22. > :11:26.hips, it included representatives of the manufacturer. The committee

:11:26. > :11:30.decided there was no need to stop the metal-on-metal hips, and

:11:30. > :11:37.patients should be told about the risks. No I a lert was issued to

:11:37. > :11:41.patients or surgeries. Today the MARA said all patients with large

:11:41. > :11:48.diameter metal-on metal hips would receive checks because of the

:11:49. > :11:54.evidence about them. Tony has fitted Maureen with a new hip, made

:11:54. > :12:01.of ceramic and plastic. How are you feeling? Fantastic. The operation

:12:01. > :12:05.went well, there was quite a lot of damage there, but we got there in

:12:05. > :12:10.time before there was damage beyond repair. I'm glad it's out.

:12:10. > :12:13.operation cost the NHS �12,000, if it is widespread it will cost the

:12:13. > :12:17.cash-trapped health service tens of millions.

:12:17. > :12:22.Our science editor is here. How worried should people be? According

:12:22. > :12:26.to the regulator, the MHRA, there are some 49,000 people out there,

:12:27. > :12:30.who have this larger diameter metal-on-metal type hip implant.

:12:30. > :12:33.They have said today that these people should have annual checks

:12:33. > :12:36.because of the safety concerns over the device. They are saying people

:12:36. > :12:40.should go to their GP if they are worried, find out what type and

:12:40. > :12:44.size of implant they have had, to see if they might require blood

:12:44. > :12:49.tests or perhaps an MRI scan, to look for any possible problems, to

:12:49. > :12:53.see if there is sign of leakage of these small metal particles. There

:12:53. > :12:58.are parallels, there seems to be, to a layman, parallels with the

:12:58. > :13:04.whole PIP breast implant thing? Common sense would tell us, in both

:13:04. > :13:08.cases the current system has failed patients. The MHRA's own website

:13:08. > :13:14.says it is responsible for ensuring that medicines and medical devices

:13:14. > :13:19.work and are acceptably safe. Yet, in both instances, it has seen

:13:19. > :13:25.reports for many years and outside pressure, and then the regulator

:13:25. > :13:29.acts. It is raising broader questions about how medical devices

:13:29. > :13:32.are regulated here and across Europe. The question is whether or

:13:32. > :13:36.not there needs to be safety tests before the devices are implants,

:13:36. > :13:40.and better safety evidence. So we are not relying on reporting by

:13:40. > :13:45.patients and healthcare professionals, but a more rigorous

:13:45. > :13:49.set-up. There is concern over the kite mark system. The notified

:13:49. > :13:53.bodies which have a contractual relationship with the makers, the

:13:53. > :13:58.certify a device does what the manufacturer says. They don't

:13:58. > :14:02.release data routinely, they can claim client confidentiality, over

:14:03. > :14:06.any data they hold. Some argue they might have a vested interest in

:14:06. > :14:09.aproving a contract, hoping for follow-on business from

:14:09. > :14:13.manufacturers, for approval for further products. All of this is

:14:13. > :14:20.increasing calls for perhaps a central European body to replace

:14:20. > :14:25.the 70 or 80 notified bodies, and the ace sem ought to look more --

:14:25. > :14:30.the system ought to look more like the system for aproving drugs, but

:14:30. > :14:34.the system for clinical trials is much less rigorous, and then there

:14:34. > :14:38.is the cost to the NHS of picking up things when they go wrong.

:14:38. > :14:43.us is the chief executive of the MHRA, the regulator of medicines

:14:43. > :14:52.and medical devices. How many clinical trials were

:14:52. > :14:55.conducted on this hip joint before it was implanted in 40,000 people?

:14:55. > :15:00.Standardised medal trials were not required. There were no clinical

:15:00. > :15:06.trials? There are clinical studies required before a joint is approved

:15:06. > :15:09.by the notified body, or it receives the Kite Mark. The nature

:15:09. > :15:12.of the study depends on the nature of the device. Do you want to

:15:12. > :15:17.apologise to all of the people for whom the operation has gone wrong?

:15:17. > :15:21.I think the agency has acted with great thoroughness in recent years.

:15:21. > :15:26.We have a situation in the UK where we are essentially concerned about

:15:26. > :15:31.the patterns of wear of these joints which, have been widely used.

:15:31. > :15:35.There are 500,000 metal-on-metal joints implanted worldwide. We were

:15:35. > :15:40.the first agency to put out a safety notice. That safety notice,

:15:40. > :15:44.for example, the advice that you gave today about people having an

:15:44. > :15:49.annual check-up, what was the new information on which that advice

:15:49. > :15:53.was based? The UK is fortunate in having the world's biggest national

:15:53. > :15:56.joint registry, which contains over a million operations of knee and

:15:56. > :16:00.hip replacements. When did you discover there was a problem?

:16:00. > :16:03.problem has emerged over the last couple of years. When the first

:16:03. > :16:10.five years of experience. You were warned six years ago, weren't you?

:16:10. > :16:14.No. If you look at the data from the National Joint Registry between

:16:14. > :16:19.2003-2008. Metal-on-metal joints were no more likely to fair than

:16:19. > :16:23.alternative manufacture. It is only in the last couple of years that

:16:23. > :16:27.the wear patterns and failure rates have diverged as they have done.

:16:27. > :16:32.it not true that there were meetings held in 2006, in which

:16:32. > :16:36.these dangers were discussed? meetings concerned the significance

:16:36. > :16:40.of the metal irons that were released, as you have heard. That

:16:40. > :16:44.the extent to which metal irons are released varies greatly from joint

:16:44. > :16:48.to joint. In some patients the levels are high, in some patients

:16:48. > :16:52.they are very low. Indeed and the patients in whom it is higher are

:16:52. > :16:56.the ones we are worried about? is precisely why we gave out advice,

:16:56. > :17:00.two years ago now, that patients with this type of advice, should

:17:00. > :17:07.have the metal irons measured in their blood, if the levels are

:17:07. > :17:11.raised, they have further investigations with images --

:17:11. > :17:15.Imaging. What has happened between that advice and today when you are

:17:15. > :17:19.advising an annual check-up? were advising all that for patients,

:17:19. > :17:25.what we have done now, with further information from the Joint Registry,

:17:25. > :17:30.this is longer experience with the joints, is we can focus the

:17:30. > :17:35.monitoring on those who need it most, the ones that have the larger

:17:35. > :17:39.head metal-on-metal device. These joints were put into people without

:17:39. > :17:44.any clinical tests, you already conceive. Were you made aware of

:17:44. > :17:49.the fact that the design of the joint had changed? You asked me

:17:49. > :17:55.were there clinical trials, I said clinical studies, but not

:17:55. > :17:58.randomised, controlled trials, of the type you might expect with the

:17:58. > :18:02.pharmaceutical industry. We are talking about the rate of wear,

:18:02. > :18:07.which can only be observed over many years, in use, over large

:18:07. > :18:11.groups of patients. There were no such tests? It would be difficult

:18:11. > :18:14.to devise randomised trials. can do it with drugs, can't you?

:18:15. > :18:20.The way that drugs give rise to problems are fundamentally

:18:20. > :18:26.different from the way that medical devises do. These people were being

:18:26. > :18:31.used as Guinea pigs? I dispute that phrase. You don't like it?

:18:31. > :18:34.cannot test the wear patterns of human joint replacements on any

:18:34. > :18:40.animal species. No you can test them on humans, which is what has

:18:40. > :18:43.happened? What we have done, and it is an essential part of all medical

:18:43. > :18:47.devise regulation, is to ensure there is -- device regulation, is

:18:47. > :18:51.to ensure there is good follow-up long-term analysis. Were you told

:18:51. > :18:56.of the change in the design? change of the design would be a

:18:56. > :19:01.matter for the notified body. that you? No. That is somebody else

:19:01. > :19:05.is it? We are the notified -- we are the competent authority, the

:19:05. > :19:09.notified body would assess the procedures. You are not aware of

:19:09. > :19:17.the changes in design? We are aware of the changes of the design, it is

:19:17. > :19:22.up to us to assess each change of design. Three of the committee who

:19:22. > :19:26.did check the design were on the payroll of the manufacturers?

:19:26. > :19:29.committee who have helped with the guidelines we are talking about

:19:29. > :19:33.today, was composed of representatives from the British

:19:33. > :19:36.orthopaedic organisation and the Hip Society, they were not

:19:36. > :19:40.manufacturer representatives, they were experts in the field. They

:19:40. > :19:44.worked with data from the National Joint Registry, which is

:19:44. > :19:49.independent, to devise the best help for patients now. When the

:19:49. > :19:56.Americans decided that these joints should not be implanted in women of

:19:56. > :20:00.childbearing age, why didn't you do the same? The evidence on that is

:20:00. > :20:05.extremely equivocal. Did you think they were being hysterical or

:20:05. > :20:10.something? The metal-on-metal joint replacements are the most widely

:20:10. > :20:15.used in the United States. The data on the effects of the metal irons,

:20:15. > :20:19.to the extent they get into blood, and secondly on the women of

:20:19. > :20:23.childbearing age, do not allow people to make firm conclusions.

:20:23. > :20:27.You tried to stop pregnant women from eating certain kinds of cheese,

:20:27. > :20:31.I suggest you that having a foreign body implanted inside your own body,

:20:31. > :20:34.with the possible, catastrophic consequences that we know about,

:20:34. > :20:38.would have been on the precautionary principle, a sensible

:20:39. > :20:43.thing to do? What we are seeking to do, by monitoring, is to detect

:20:43. > :20:46.those patients that do generate a raised level of cobalt and chromium

:20:46. > :20:50.in the blood. Those patients will go on to have further investigation

:20:50. > :20:54.with a view to removing the joint if it is necessary. We are intent

:20:54. > :20:58.on protecting patients from the effect of raised metal irons in

:20:58. > :21:01.blood. This monitoring is with a view to the NHS then paying to have

:21:01. > :21:06.the things taken out of people, is it? The purpose of the monitoring

:21:06. > :21:10.is to make sure that in that minority of patients, in whom there

:21:10. > :21:14.is accelerated wear, the detection of that wear early ensures the

:21:14. > :21:18.joint can be replaced at a time when it is most satisfactorily done.

:21:18. > :21:24.What is the costs of removing one? I honestly haven't examined the

:21:24. > :21:28.costs. We are talking about many thousands of pounds. We are, it is

:21:28. > :21:32.hugely expensive? Hip joints wear out, it is a general phenomenon of

:21:32. > :21:37.all hip joints f you look at the types of joints developed, most

:21:37. > :21:41.have been driven by the attempt to reduce the rate that they wear out.

:21:41. > :21:44.They don't all wear out while poisoning the patient, do they?

:21:44. > :21:49.point you are raising about poisoning the patient, is exactly

:21:49. > :21:58.the reason we are setting in place this monitoring arrangement for

:21:58. > :22:01.patients with this particular type of hip. This time tomorrow night we

:22:02. > :22:05.will hear from the Health Secretary, as we devote the whole programme to

:22:05. > :22:08.the controversy surrounding the Government's health bill. The

:22:08. > :22:11.latest stage of the steeplechase to become the Republican candidate

:22:11. > :22:16.tole cha eing Barack Obama this year is taking place in Michigan.

:22:16. > :22:20.Each of the four men left in the race say they will stay the course

:22:20. > :22:23.until the party convention in the summer. In the meantime they have

:22:23. > :22:28.all amplely demonstrated that no- one is meaner to a politician, than

:22:28. > :22:34.one who claims to be on the same side. In a moment I will talk to

:22:34. > :22:38.the man who thought he could turn his experience in running a pizza

:22:38. > :22:45.parlour empire to running the United States, but has had to bow

:22:45. > :22:51.out of the race. Herman Cain was the early Republican pace setter,

:22:51. > :22:56.who inspired the bumper sticker "the pizza man always delivers".

:22:56. > :23:02.And deliver, in many ways, Herman Cain did.

:23:02. > :23:07.After announcing his presidential cadidacy in May last year, he

:23:07. > :23:10.quickly earned the accolade of most covered candidate in the race. His

:23:11. > :23:17.unorthodox tendencies had everything the media could ask for.

:23:17. > :23:27.Whacky, viral ads. We can take this country back.

:23:27. > :23:32.

:23:32. > :23:35.Foreign policy stumbles. When they asked me who is the President of U-

:23:35. > :23:43.bek-ebek-beck-stan I will say I don't know, do you.

:23:43. > :23:48.There was even singing. But he was propelled from businessman to the

:23:48. > :23:52.frontline. His proposed 9-9-9 tax plan, along with debate

:23:52. > :23:57.performances confirmed him as the Republican front runner, he briefly

:23:57. > :24:01.led President Obama in the polls. A stellar record had made his name.

:24:01. > :24:06.Herman Cain grabbed the opportunity to turn around two floundering

:24:06. > :24:11.businesses. First, transforming the fortunes of 400 Burger King stores

:24:11. > :24:17.in Philadelphia, from the least, to the most profitable in the company.

:24:17. > :24:21.Before saving Godfather's Pizza from bankruptcy. Initial low Cain

:24:21. > :24:26.managed to dismiss those who criticised his lack of political

:24:26. > :24:31.experience, he, he said, was part of the solution, and professional

:24:31. > :24:38.politicians, part of the problem. But ultimately, uncomfortable

:24:38. > :24:46.allegations of sexual harassment tightened the noose around his name.

:24:46. > :24:51.The charges and accusations are absolutely rejected. They simply

:24:51. > :24:56.didn't happen. Finally, in December last year, off the back of sliding

:24:56. > :24:59.poll results, in spite of his numerous public denials of

:24:59. > :25:07.wrongdoing, Cain announced he was suspending his run for the

:25:07. > :25:15.presidency. With a lot of prayer, and soul searching, I am suspending

:25:15. > :25:20.my presidential campaign. The Godfather of common sense fell

:25:20. > :25:23.foul of what Thomas Jeff son dubbed the painful and thankless office,

:25:23. > :25:33.before even assuming the office himself. Leaving others to fight it

:25:33. > :25:39.out for the White House. In his first interview as the former

:25:39. > :25:45.candidate for the Republican party presidential campaign, Herman Cain.

:25:45. > :25:48.Did you enjoy your runnout for the presidency? I did enjoy it, the

:25:48. > :25:52.best part was the feedback and response of the people, and

:25:52. > :25:57.secondly, their response to the bold solutions that I presented as

:25:57. > :26:05.part of my campaign. But I did enjoy it. You sounded pretty bitter

:26:05. > :26:09.when you quit? I wasn't bitter, I was angry, because the false

:26:09. > :26:12.accusations could not be proved, and how do you prove you didn't do

:26:12. > :26:16.something, or that you weren't somewhere that someone said. The

:26:16. > :26:20.bottom line was, it was my word against someone else, and they had

:26:20. > :26:24.absolutely no proof. That was the part that angered me. I might add,

:26:24. > :26:28.that I was going to stay in the race. But because of the coverage

:26:28. > :26:34.of the false accusations on the part of the media, it was causing

:26:34. > :26:38.undue pain on my wife and my family. And I made a decision, family first,

:26:38. > :26:43.rather than stay in, and allow them to continue to present these

:26:43. > :26:53.accusations as if they were true, when in fact they were not. Why do

:26:53. > :26:53.

:26:53. > :26:58.you think you couldn't cut it in that race? On the contrary, I did

:26:58. > :27:01.believe I could cut it in that race. I did believe my appeal to the

:27:01. > :27:06.American people was number one. I proposed common sense solutions to

:27:06. > :27:10.our problems. Secondly, I didn't speak in political speak, I had

:27:10. > :27:16.specific solutions. I cut it in the race, that wasn't the issue, the

:27:16. > :27:20.issue was the constant spinning and respinning of unfounded allegations

:27:20. > :27:25.that became a distraction, not only to me and my campaign, but it

:27:25. > :27:29.became very painful to my family. I wasn't going to put them through

:27:29. > :27:33.that. What did you make of things like, you know, your boast that you

:27:33. > :27:38.couldn't name the President of Uzbekistan, that was a pretty silly

:27:38. > :27:43.thing to do, wasn't it? I don't think it was silly, I think it is

:27:43. > :27:47.silly to ask a candidate to know the head of every small country in

:27:47. > :27:51.the world, without some reference. I was driving home a point, that is,

:27:51. > :27:54.you don't have to be an international expert, in order to

:27:54. > :27:57.be able to make the appropriate decisions, once you have the right

:27:57. > :28:02.information, once you have the right intelligence information, and

:28:02. > :28:07.once you have an opportunity to analyse the situation. It is

:28:07. > :28:11.impossible, Jeremy, to answer thousands of hypothetical questions

:28:11. > :28:14.about hundreds of countries without knowing exact low what it is that

:28:14. > :28:21.you are supposed to talk -- exactly what it is you are supposed to talk

:28:21. > :28:24.about. I called those questions, "goch cha questions", I wasn't

:28:24. > :28:28.going to worry about answering those questions. An American

:28:28. > :28:32.President has to know that sort of stuff doesn't he? You don't have to

:28:32. > :28:42.know the head of every state in the world, before you become President.

:28:42. > :28:46.That was my point. Yes you would need to know it if it was a

:28:46. > :28:49.relationship you were going to cultivate or analyse. But to pick a

:28:49. > :28:55.random country and expect a candidate to know off the top of

:28:55. > :28:59.his head is unrealistic. The thing is, the American people agreed with

:28:59. > :29:02.me. When you say the American people agreed with you, you made a

:29:02. > :29:07.distinction in one of your comments about how there was a political

:29:07. > :29:16.class in the country, a media class, and then there was "the people",

:29:16. > :29:19.can youamify that? Sure, the politic -- political establishment

:29:19. > :29:24.has a certain tendency as far as candidates they want to support.

:29:24. > :29:29.Secondly, the political class, just about everybody currently holding

:29:29. > :29:37.office in Washington DC, including the President, they make decisions

:29:37. > :29:42.and proposals to sustain the status quo. The media class cover politics

:29:42. > :29:48.and everything else. They also sometimes are very biased in their

:29:48. > :29:53.coverage of stories. They do, what I call, fly-spec everything you say

:29:53. > :29:59.as a candidate, especially if you get the lead in some of the primary

:29:59. > :30:04.results. Then the people are every day normal people, trying to take

:30:04. > :30:07.care of their family, save for the kids education, they have a job and

:30:07. > :30:10.working hard. They see in the United States Washington is broken,

:30:10. > :30:15.it doesn't solve things, it continues to move problems down the

:30:15. > :30:20.road, and secondly, we have a serious financial challenge that

:30:20. > :30:25.right now they are not adequate low addressing. It sounds as if your

:30:25. > :30:31.system is pretty broke? It is broke, that is the word I use when

:30:31. > :30:36.decribing it to someone. When you have got a $16 trillion national

:30:36. > :30:40.debt, and over $5 trillion occurring in the last three years,

:30:40. > :30:44.we have a serious problem. We have a serious problem because we have

:30:44. > :30:49.to borrow from other countries to service the debt. If you look at

:30:49. > :30:53.the fact we are now spending $10 billion a day in order to be able

:30:53. > :31:01.to just service the debt, we are broke, and we have a serious

:31:01. > :31:05.financial issue. The Employment Minister has his work cut out these

:31:05. > :31:08.days, trying desperately to restore some credibility to the

:31:08. > :31:11.Government's work experience scheme. One company after another has

:31:11. > :31:19.pulled out of the scheme, embarrassed by accusations that

:31:19. > :31:29.unpaid work is being forced on to them with the threat of withdrawal

:31:29. > :31:34.of benefits. The head of the chain greings invited us Gregg invited us

:31:34. > :31:41.to look at how it works there. Look at the rather thing, expanding

:31:41. > :31:46.business, creating jobs, no wonder the Government took comfort when

:31:46. > :31:50.Gregg's bakery signed up to its work experience scheme. In these

:31:50. > :31:54.unassuming offices in Newcastle, support can no longer be taken for

:31:54. > :31:57.granted, posing a threat to a big part of the national welfare-to-

:31:57. > :32:01.work programme. They have told us they have frozen the offer of

:32:01. > :32:04.unpaid work placements, they may go further. There shouldn't be a

:32:04. > :32:08.question about whether companies should be offering work experience

:32:08. > :32:12.opportunities to the young unemployed, but inevitably, when

:32:12. > :32:15.there is criticism, as a company you have to review the scheme and

:32:15. > :32:18.decide if you still believe it is right for the company to offer

:32:18. > :32:21.those opportunities to the young. We still believe very much in the

:32:21. > :32:25.scheme, but there is one part of it the Government needs to review.

:32:25. > :32:29.That is the part that if, having taken up a placement, somebody

:32:29. > :32:34.decides they don't want to complete the placement, we don't feel they

:32:34. > :32:39.should lose their benefits. Atticus tomorrow mer care, the usual

:32:39. > :32:44.concerns about -- at customer care, the usual concerns about sandwich

:32:44. > :32:49.deals, they have been overcome by customer complaints about the

:32:49. > :32:54.scheme. It has put Matthew Nelson in a difficult position, he's in

:32:54. > :32:59.the office that is handling the calls, despite being on a work

:32:59. > :33:02.placement himself. It is his first sniff of a job opportunity since he

:33:02. > :33:06.graduated from Newcastle University last summer. I'm getting the most

:33:06. > :33:09.out of this, because I'm getting the experience, the company isn't

:33:09. > :33:11.getting that much, other than the work I'm doing, they are not

:33:11. > :33:17.getting enticements from the Government or anything like that,

:33:17. > :33:21.or financial support, just for me to be coming here. Well just me

:33:21. > :33:24.getting the experience is really helpful in my development, and

:33:24. > :33:31.personal development. You think you are getting the most out of it?

:33:31. > :33:34.Definitely, yes. Since last June, Gregg's has offered more than 40

:33:34. > :33:39.placements, 14 have led to permanent jobs. The scheme is

:33:39. > :33:44.voluntary, but if, after a week, a jobseeker pulls out, they risk

:33:44. > :33:51.losing benefits. It is this threat that means future placements with

:33:51. > :33:55.Gregg's, between 50-100 per yor, are all now at risk. -- a year, are

:33:55. > :34:00.now all at risk. The company says it is very sad. Gregg's is very

:34:00. > :34:06.positive about the scheme it says is helping young people, they are

:34:06. > :34:11.waviering, -- wavering. The tide of public opinion is pushing a

:34:11. > :34:18.Government policy dangerously close to the rocks. Other companies have

:34:18. > :34:22.already jumped ship. While others, like Matalan, Argos, and now Greggs,

:34:22. > :34:26.are taking to the lifeboats. For 19-year-old Daniel Kelly, the

:34:26. > :34:30.scheme rescued him from unemployment. He has been taken on

:34:30. > :34:34.permanently by Greggs, in the payroll team. When I signed up for

:34:34. > :34:38.a wage, I signed up primarily for the experience, that is all I

:34:38. > :34:42.wanted from it. You don't think people in your position are being

:34:42. > :34:46.exploited? I think we have people currently on it, I'm working with

:34:46. > :34:49.someone on the scheme, they love it, they don't think it is exploiting

:34:49. > :34:54.people. It gives awe bit of purpose. It is something to wake up and do

:34:54. > :34:58.in the morning. This is a recent edition to the chain, it might be

:34:58. > :35:03.because the firm is growing that existing staff have no problem with

:35:03. > :35:06.the idea of unpaid placements. think most people when they are

:35:06. > :35:10.working here would see it from the positive and see them as another

:35:10. > :35:14.member of staff, that is finding a different path into the company,

:35:14. > :35:20.rather than anything negative. scheme, run through the Jobcentre,

:35:20. > :35:27.first attracted big business, but now risks losing it under the tide

:35:27. > :35:30.of bad PR. Greggs tells us the threat of job seekers losing

:35:30. > :35:34.benefits was never explained. wasn't clear enough at the

:35:34. > :35:42.beginning. Even now it is not clear just how many people have actually

:35:42. > :35:45.been penalise Ford not completing their placement. So I think --

:35:45. > :35:48.penalised for not completing their placement. It was always going to

:35:48. > :35:51.be an issue that affects a very small number of people, and it

:35:51. > :35:54.wasn't briefed very clearly as a big part of the scheme. It was

:35:54. > :35:58.always intended to be for one or two individuals, if indeed it was

:35:58. > :36:02.required at all. But that should have been much clearer and up front

:36:02. > :36:06.with employers, at the very beginning. Tomorrow, the minister,

:36:06. > :36:11.Chris Grayling, will meet employers like Greggs, to keep their support

:36:11. > :36:15.he may have to sacrifice a central principle of the welfare-to-work

:36:15. > :36:22.programme, that the unemployed must fully engage with it, or face

:36:22. > :36:28.sanction. The Treasury has found �500 million

:36:28. > :36:32.down the back of the sofa, well, it has stopped banks not paying �500

:36:32. > :36:35.million in taxes. Barclays says it is perfectly happy to pay tax, it

:36:35. > :36:40.had been planning to dodge. They hadn't done anything illegal, but

:36:40. > :36:45.trying to avoid paying taxes when banks have had to be bailed out by

:36:45. > :36:49.the taxpayer, at enormous cost, is about as popular as a flat lent man

:36:49. > :36:54.in a lift. What were these schemes? There were

:36:54. > :36:57.two schemes Barclays was use to go minimise tax bills. It was claiming

:36:57. > :37:03.tax credits on a flow of income that hadn't been taxed in the first

:37:03. > :37:09.place. The second one I will refer to a graph involving corporate

:37:09. > :37:14.bonds, IOUs. This is when a company sells bonds in itself to the market

:37:14. > :37:18.t promises to pay the market a certain amount of money by a

:37:18. > :37:23.certain date, we will call that A, in terms of the source of money,

:37:23. > :37:28.last December Barclays decided to buy some of those bonds back from

:37:28. > :37:33.the market, which garn earned an amount of money called B, so B

:37:33. > :37:37.minus A is a profit, under the old loophole not subject to corporation

:37:37. > :37:41.tax, so they didn't mention anything to it. Of that lop hole,

:37:41. > :37:46.it was closed yesterday, -- loophole, it was closed yesterday,

:37:46. > :37:51.it was backdated to December last year. It applies retrospectively.

:37:51. > :37:54.But I thought financial legislation wasn't supposed to apply

:37:54. > :38:00.retrospectively? Normal low that is the case. The key thing is the --

:38:00. > :38:04.normally that is the case. The key thing is the retrospective part of

:38:04. > :38:10.it. There are groups out there saying doing it for that group, why

:38:10. > :38:16.not for our group. One tax consultant said you only lose your

:38:16. > :38:19.virginity once, so serious is the precedent. Overseas companies might

:38:19. > :38:26.think they will invest in Britain because of the stable tax regime,

:38:26. > :38:31.but nas not necessarily the -- that is not necessarily the case now.

:38:32. > :38:36.The Treasury wants to yield �500 million, Barclays are in the

:38:36. > :38:42.picture for �300 million, �200 million is unnamed. Will it be

:38:42. > :38:45.named? We hope so, we think the Conservative chairman of the all-

:38:45. > :38:48.party Parliamentary Committee on taxation, he will write to the

:38:48. > :38:53.Chancellor, asking him, the Chancellor, to name these companies,

:38:53. > :38:56.if the Chancellor can't, because they are on going cases, so he

:38:57. > :39:00.can't, he says why don't you put it in the parliamentary record, in the

:39:00. > :39:05.library, then we will get a look at the names, when the loopholes are

:39:05. > :39:09.closed and the tax cases are closed too. That may take a year. David

:39:09. > :39:15.Gauke, the Treasury minister, with responsibility for the tax system

:39:16. > :39:19.is here. �300 million of it is Barclays,

:39:19. > :39:27.�200 million is company else's liability, is that right? I think

:39:27. > :39:31.what I should say, on the numbers, is that as far as this particular

:39:31. > :39:37.scheme, the debt buyback scheme is concerned, if a bank or other

:39:37. > :39:42.entity is engaged in it, they should notify HMRC, under the

:39:42. > :39:47.disclosure of tax avoidance set of rules, and nobody else has. Are you

:39:47. > :39:51.getting back �300 million or �500 million? There is an amount, which

:39:51. > :39:55.we think is, if you like, the retrospective element, that has

:39:55. > :39:58.already happened, which is coming from the one entity, for example,

:39:58. > :40:01.Barclays, they have declared themselves it is them. The rest of

:40:01. > :40:05.the calculation. I know it is complicated, but let me make this

:40:05. > :40:10.point. The rest of the calculation is about behavioral r ral change,

:40:10. > :40:13.and that may be -- behavioural change, and that may be some

:40:13. > :40:19.entities or those who have already taken advantage of it. I'm being

:40:19. > :40:28.slow, I expect, but the figure is �300 million, that is what Barclays

:40:28. > :40:32.say they think they are on the hook for, the other �200 million is the

:40:32. > :40:40.speculative thing? It is the estimate HMRC have made. These are

:40:40. > :40:44.preliminary estimates, and they will have to be run past the budget

:40:44. > :40:49.of -- office of budget responsibility. With future bank

:40:49. > :40:53.activity, so. Why can't you tell us who you might think might owe the

:40:53. > :40:57.money? There is only one entity at the moment we are aware of, that is

:40:57. > :41:04.doing this. The only bank you know about doing this was Barclays, and

:41:04. > :41:08.bark close say the extent of their liability is �300 million not �500

:41:08. > :41:15.million. That is what they say. believe Barclays are on the hook

:41:15. > :41:21.for the full �500 million. We think the �300 million is up to now, and

:41:21. > :41:26.the �200 million is the future. We can get hung up on the two figures.

:41:26. > :41:32.It is a lot of money? It is, this was a very aggressive scheme and we

:41:32. > :41:36.have closed it down. This question of retrospective legislation, it

:41:36. > :41:40.has been a principle of financial legislation in this country, has

:41:40. > :41:44.had not, that it isn't retrospective. If you are going to

:41:44. > :41:48.do it in this case, why don't you just declare that the rate of

:41:48. > :41:53.income tax last yor, shouldn't have been what it is, it should -- last

:41:53. > :41:58.year, shouldn't have been what it is, it should have been 7 %, you

:41:58. > :42:01.can do anything? There is a concern about how retrospective legislation

:42:01. > :42:04.is used, if you misuse it creates uncertainty. I would be the first

:42:04. > :42:08.to argue that point. There are particular circumstances that apply

:42:08. > :42:12.in this case. There are always particular circumstances, look at

:42:12. > :42:17.the Vodaphone deal, and the Goldman Sachs deal, any of those? If you

:42:17. > :42:20.look at this particular case, what you have got here is that you have

:42:20. > :42:25.got a taxpayer, that has signed a Code of Practise, saying it will

:42:25. > :42:29.not engage in aggressive tax avoidance activity. You have also a

:42:29. > :42:34.particular area, Joe described it very well, the debt boyback

:42:34. > :42:38.arrangements. Actually the previous -- buyback arrangements. The

:42:38. > :42:41.previous Government in 2009 made statements and legislated in 2010,

:42:42. > :42:45.to try to prevent abuse of that, and try to close a loophole. This

:42:45. > :42:50.was an area, if you like, where there was a very clear sign, keep

:42:50. > :42:55.off the grass, I think everybody knew that this was an area where

:42:55. > :42:59.there had been a loophole, it was closed and, and nonetheless, one

:43:00. > :43:03.taxpayer went back into this area, in a way that was very aggressive,

:43:03. > :43:08.very contrived, and clearly against what the spirit of the law was.

:43:08. > :43:12.won't be doing this against Vodaphone and Goldman Sachs or

:43:12. > :43:16.anybody else on other arrangements? We would only use retrospective

:43:16. > :43:21.legislation in exceptional circumstances, where there was a

:43:21. > :43:25.very stkroing case, where it is very -- strong case, where it is

:43:25. > :43:30.very artificial and contrived. might do it again? Nobody will Raul

:43:31. > :43:35.it out. You have already said it is undesirable? It should only be used

:43:35. > :43:40.in very exceptional cases. Treasury's enthusiasm for

:43:40. > :43:43.maximising the tax makers motivated by the need to close a huge hole in

:43:43. > :43:47.the public finances f that goal will be met the economy will have

:43:47. > :43:51.to start growing. Today the cabinet met to look at the progress being

:43:51. > :43:55.made to promote growth ahead of next month's budget. Our political

:43:55. > :43:58.editor is here. What did they discuss? It was a review of the

:43:58. > :44:02.growth review. A year ago they said we need measures to get this

:44:02. > :44:06.economy going again, and three weeks away from the budget, they

:44:06. > :44:10.had to say where have we got to, in the words of one Downing Street

:44:10. > :44:15.person it is shaking the tree on existing measures, can we get more

:44:15. > :44:23.out of them. What was most striking is it was what we call, blue-on-

:44:23. > :44:27.blue, and yellow-on-yellow, across the benches sniping. It was a line

:44:27. > :44:30.that William Hague pushed, but today the Prime Minister pushed it,

:44:31. > :44:37.and it is this, at the moment some of the big infrastructure projects

:44:37. > :44:41.and the big things making a difference to UK Plc, appear to be

:44:42. > :44:44.blocked by EU rulings. Things people have been talking to me

:44:44. > :44:49.about, the Porton Down in Cornwall, if it got off the ground it would

:44:49. > :44:53.be big. In other parts of the country they don't talk it as

:44:54. > :44:58.gospel and sometimes they ignore them. The Prime Minister and the

:44:58. > :45:01.Environment Secretary, who has to lock at things like the EU Habitats

:45:01. > :45:07.Directive, says if there is a balance of risk and you might get

:45:07. > :45:12.something from it, go for it. It is extraordinary for the Prime

:45:12. > :45:16.Minister to say let's not err on the side of caution. Anybody else?

:45:16. > :45:19.Ken Clark, the Justice Secretary, weighed in on business, he made an

:45:19. > :45:23.intervention saying we are not doing enough for small businesses,

:45:23. > :45:30.which we know. Banks aren't lending to them, he said, there is too much

:45:30. > :45:35.red tape, how it was relayed to me is this is a guy, former Chancellor

:45:35. > :45:40.from pre-1997, who had there not been a coalition, he would have

:45:40. > :45:45.been the Business Secretary. It was interpreted as a shot across Vince

:45:45. > :45:49.Cable's Boug h, and some would say he's a Chancellor not that keen on

:45:49. > :45:53.business. The Chancellor wanted to know what was happening to another

:45:53. > :45:57.controversial piece of legislation, another things causing problems is

:45:57. > :46:02.how they are reforming planing. They think if they can unclutter

:46:02. > :46:05.the planing system they can get growth going. He wants to know from

:46:05. > :46:09.the community secretary if he will go forward on this. The National

:46:10. > :46:13.Trust hate it, we need the Government response. Pickwick said

:46:13. > :46:17.they will come forward with something -- Pickles said they

:46:17. > :46:21.would come forward with something. This time last night, the City of

:46:21. > :46:24.London police were readying themselves for removing the Occupy

:46:24. > :46:29.London Protest from outside St Paul's in London.

:46:29. > :46:37.There ain't no more # You have taken everything

:46:37. > :46:47.# My belief in mother earth # Can you ignore

:46:47. > :46:52.

:46:52. > :46:58.# My faith in everything # Away away

:46:58. > :47:08.# And don't say neighbour Manage you will try

:47:08. > :47:10.

:47:10. > :47:13.# Come up and see me Tuesday was a very cloudy but

:47:13. > :47:16.exceptionally mild day, particularly across the north and

:47:16. > :47:20.east. Keeping the cloudy mild conditions on into Wednesday, most

:47:20. > :47:23.of us will start off with rather grey and overcast skies, things

:47:23. > :47:26.will tend to brighten up into the afternoon. The north-east of

:47:26. > :47:33.England will be favoured, seeing some decent breaks in the cloud.

:47:33. > :47:37.Where we get these temperatures will lift to 14 degroos, that will

:47:37. > :47:41.feel pleasant in the sunshine. We could see limited brighter spells,

:47:41. > :47:47.the best of the breaks in the cloud are likely further west. A much

:47:47. > :47:51.sunnier day for South-West England, Wales, the West Midlands and on

:47:51. > :47:56.towards Greater Manchester, sunny spells reaching 11-13. In Northern

:47:56. > :47:59.Ireland a similar day to yesterday, rather cloudy but a few brighter

:47:59. > :48:04.spells. Western Scotland keeps the blanket of cloud, with a few spots

:48:04. > :48:07.of rain over the western hills. East of the Grampians sunshine into

:48:07. > :48:11.Aberdeenshire, it won't be as toastie as it was on Tuesday.

:48:11. > :48:14.Staying rather cloudy for most of us, particularly into the morning.

:48:14. > :48:18.Things turning a little bit brighter, in the London area,

:48:18. > :48:21.temperatures cooling off a touch as we go into Thursday. That is not

:48:21. > :48:25.just for London, it is a trend as we go on through the latter stages

:48:25. > :48:29.of this week, across much of the country. For Thursday a good dole