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| TX: 06.10.06 - Stem Cells PRESENTERS: LIZ BARCLAY |
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| Downloaded from www.bbc.co.uk/radio4 THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT. BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY. BARCLAY A clinic in Holland where dozens of British patients have been treated with controversial stem cells has been banned from carrying out the treatment. The Dutch Healthcare Inspectorate says the Preventive Medicine Clinic, or PMC, in Rotterdam can't prove where its stem cells are coming from and is putting patients, many with MS, at risk. The ban began at 5.00 p.m. on Monday evening but You and Yours has spoken to a British man who says he was given stem cell treatment at the clinic on Wednesday of this week, two days after the ban came in. Our reporter Carolyn Atkinson has more. ATKINSON The Dutch authorities made their decision after a three month long investigation into the stem treatments that PMC has been offering to patients, patients from all over the world, many of them from the UK, about 150 to date. Now the reason they decided to ban this treatment - and I should point out that the clinic itself is not being shut down - is because, and I quote: "The clinic is unable to demonstrate the origin, suitability and safety". Now I've been speaking to Fryson Vandebeek [phon.] from the Dutch Health Inspectorate about why they banned the treatment. ZEBEEK Because we think the PMC is not providing responsible care. The PMC is unable to demonstrate the origin and the suitability and the safety of the stem cells it uses. And we think that it jeopardises the health and safety of patients. For example, it exposes patients to the risk of infection with HIV or Creutzfeldt-Jacob Disease. But also to allergic reactions, malignant tumours or rejection reactions. So that's quite serious. ATKINSON Now I understand that the decision to ban the stem cell treatments had already been made when it emerged last Friday that a British man, who'd just had the treatment, was then rushed to the emergency clinic at Rotterdam's Havenziekenhuis Hospital with what doctors there described as serious complications following the stem cell treatment he'd at the PMC. Now the patient had acute allergic reaction, the hospital tells me that the staff there were unhappy with the information they'd been given from the PMC about what had happened to the man and they then informed the authorities. Now I can say the man was treated with anti-allergen medication and he is now back in the UK. BARCLAY And what can you tell us about this other British man who says he had the stem cell treatment at the PMC clinic after the ban came in? ATKINSON Well I've been speaking to this 47 year old man from County Durham who says he went to Holland on Tuesday of this week, had the preliminary treatment that they give and he says he then had the stem cell treatment on Wednesday of this week, that's two days into the ban. Now he got home yesterday and I was speaking to him this morning. He told me he feels fantastic and he says he'll speak to us in a few weeks time. BARCLAY Stem cells are a buzz word aren't they at the moment and many doctors are really excited at the potential. ATKINSON Well potential is perhaps the key word here. On You and Yours we've consistently been reporting on stem cell research and there is indeed - there are some areas where they do appear to work, we've reported on a particular heart condition which appears to respond and full trials are now taking place but that's the level that the medical establishment would argue that we're at - trials - not wholesale treatments or cures. The difference with this clinic is that it's been offering treatment now and that has been extremely controversial. The medical establishment say if these treatments really do work then they'd be a world breakthrough and the evidence should be produced for all of us to see. BARCLAY Well on the line from Alicante is the medical director of the Preventive Medicine Clinic, PMC, in Rotterdam, Dr Robert Tressell, who's one of the doctors there who's been carrying out the stem cell treatments for the past three years. Dr Tressell, thank you for joining us. What's your reaction to the banning of this treatment? TRESSELL Well it came as a bit of a surprise. We - since June we have been in a constant - quite a positive dialogue with the health inspector and in order to comply with all the new rules and the regulations of the European guidelines and it was quite a positive state. So this did come as a surprise. BARCLAY Why could you not show where your stem cells were from and produce any evidence of their safety? TRESSELL We have told them from the very first what our sources were and there is totally nothing to hide about the origin, the quality or the safety of the stem cells. BARCLAY Yes but why were you not able to produce evidence of that? TRESSELL We have evidence of the source, obviously we have certificates of analysis, but if they want specific different certificates that's what we were working on. So that's why it was quite a surprise because it was actually quite a positive dialogue between and we are definitely complying with all the rules and regulations that are going to be put in place, there's not even - you know we are the first clinic doing this so there were no rules set into the law. It's a new field and therefore it has a new set of rules and obviously as we're the first one we will be the first ones to comply with the rules. BARCLAY So what do you say to the claim by the Dutch Inspectorate that you were putting patients' lives at risk? TRESSELL The quality of the cells has never been of any concern of us. We - besides the certificates of analysis that are qualified as all the tests that are done for blood transfusions we also do our own checks on the blood, so if that were the case we would never have offered it to any patient. BARCLAY How well do you think this treatment works? TRESSELL The patients - the best responders are the people with spinal cord injuries and relative young children with brain damage. We've treated almost all neurological patients. The fairly large group are the MS patients and they seem to have quite a variable response because of the nature of the disease, there's about 10% that has an excellent extremely well response, there's 70% that has a favourable response in about three months so that they would say yes I would do it again and there's 30% of non responders. And obviously we're looking what is the difference between them and how can we select these people. BARCLAY Can I ask you about this British man who says he had the stem cell treatment at PMC on Wednesday this week? TRESSELL That is absolutely not true because we've cancelled all patients. He may have gone to another doctor somewhere else but he has not been given treatment by us because we're banned and we obviously comply with the ban. BARCLAY Are there other clinics in Rotterdam offering this service? TRESSELL No. No he must have gone somewhere else outside Holland. BARCLAY Dr Tressell thank you for joining us. Carolyn Atkinson is still here, Carolyn is this ban going to stay do you think? ATKINSON Well the ban at the moment runs through to Monday evening 5 o'clock, the Dutch Inspectorate has already - have already, I should say, asked the Minister of Health to renew that order and that is expected to happen. As for this British man that Dr Tressell was talking about, he's had the stem cell treatment, Fryson Vandebeek, from the Dutch Inspectorate, who we heard from earlier, has given her reaction to the allegations, she's basically saying that they will investigate this further because they need to be sure that he hasn't had treatment after the ban. BARCLAY Carolyn Atkinson thank you for joining us. BARCLAY A clinic in Holland where dozens of British patients have been treated with controversial stem cells has been banned from carrying out the treatment. The Dutch Healthcare Inspectorate says the Preventive Medicine Clinic, or PMC, in Rotterdam can't prove where its stem cells are coming from and is putting patients, many with MS, at risk. The ban began at 5.00 p.m. on Monday evening but You and Yours has spoken to a British man who says he was given stem cell treatment at the clinic on Wednesday of this week, two days after the ban came in. Our reporter Carolyn Atkinson has more. ATKINSON The Dutch authorities made their decision after a three month long investigation into the stem treatments that PMC has been offering to patients, patients from all over the world, many of them from the UK, about 150 to date. Now the reason they decided to ban this treatment - and I should point out that the clinic itself is not being shut down - is because, and I quote: "The clinic is unable to demonstrate the origin, suitability and safety". Now I've been speaking to Fryson Vandebeek [phon.] from the Dutch Health Inspectorate about why they banned the treatment. ZEBEEK Because we think the PMC is not providing responsible care. The PMC is unable to demonstrate the origin and the suitability and the safety of the stem cells it uses. And we think that it jeopardises the health and safety of patients. For example, it exposes patients to the risk of infection with HIV or Creutzfeldt-Jacob Disease. But also to allergic reactions, malignant tumours or rejection reactions. So that's quite serious. ATKINSON Now I understand that the decision to ban the stem cell treatments had already been made when it emerged last Friday that a British man, who'd just had the treatment, was then rushed to the emergency clinic at Rotterdam's Havenziekenhuis Hospital with what doctors there described as serious complications following the stem cell treatment he'd at the PMC. Now the patient had acute allergic reaction, the hospital tells me that the staff there were unhappy with the information they'd been given from the PMC about what had happened to the man and they then informed the authorities. Now I can say the man was treated with anti-allergen medication and he is now back in the UK. BARCLAY And what can you tell us about this other British man who says he had the stem cell treatment at the PMC clinic after the ban came in? ATKINSON Well I've been speaking to this 47 year old man from County Durham who says he went to Holland on Tuesday of this week, had the preliminary treatment that they give and he says he then had the stem cell treatment on Wednesday of this week, that's two days into the ban. Now he got home yesterday and I was speaking to him this morning. He told me he feels fantastic and he says he'll speak to us in a few weeks time. BARCLAY Stem cells are a buzz word aren't they at the moment and many doctors are really excited at the potential. ATKINSON Well potential is perhaps the key word here. On You and Yours we've consistently been reporting on stem cell research and there is indeed - there are some areas where they do appear to work, we've reported on a particular heart condition which appears to respond and full trials are now taking place but that's the level that the medical establishment would argue that we're at - trials - not wholesale treatments or cures. The difference with this clinic is that it's been offering treatment now and that has been extremely controversial. The medical establishment say if these treatments really do work then they'd be a world breakthrough and the evidence should be produced for all of us to see. BARCLAY Well on the line from Alicante is the medical director of the Preventive Medicine Clinic, PMC, in Rotterdam, Dr Robert Tressell, who's one of the doctors there who's been carrying out the stem cell treatments for the past three years. Dr Tressell, thank you for joining us. What's your reaction to the banning of this treatment? TRESSELL Well it came as a bit of a surprise. We - since June we have been in a constant - quite a positive dialogue with the health inspector and in order to comply with all the new rules and the regulations of the European guidelines and it was quite a positive state. So this did come as a surprise. BARCLAY Why could you not show where your stem cells were from and produce any evidence of their safety? TRESSELL We have told them from the very first what our sources were and there is totally nothing to hide about the origin, the quality or the safety of the stem cells. BARCLAY Yes but why were you not able to produce evidence of that? TRESSELL We have evidence of the source, obviously we have certificates of analysis, but if they want specific different certificates that's what we were working on. So that's why it was quite a surprise because it was actually quite a positive dialogue between and we are definitely complying with all the rules and regulations that are going to be put in place, there's not even - you know we are the first clinic doing this so there were no rules set into the law. It's a new field and therefore it has a new set of rules and obviously as we're the first one we will be the first ones to comply with the rules. BARCLAY So what do you say to the claim by the Dutch Inspectorate that you were putting patients' lives at risk? TRESSELL The quality of the cells has never been of any concern of us. We - besides the certificates of analysis that are qualified as all the tests that are done for blood transfusions we also do our own checks on the blood, so if that were the case we would never have offered it to any patient. BARCLAY How well do you think this treatment works? TRESSELL The patients - the best responders are the people with spinal cord injuries and relative young children with brain damage. We've treated almost all neurological patients. The fairly large group are the MS patients and they seem to have quite a variable response because of the nature of the disease, there's about 10% that has an excellent extremely well response, there's 70% that has a favourable response in about three months so that they would say yes I would do it again and there's 30% of non responders. And obviously we're looking what is the difference between them and how can we select these people. BARCLAY Can I ask you about this British man who says he had the stem cell treatment at PMC on Wednesday this week? TRESSELL That is absolutely not true because we've cancelled all patients. He may have gone to another doctor somewhere else but he has not been given treatment by us because we're banned and we obviously comply with the ban. BARCLAY Are there other clinics in Rotterdam offering this service? TRESSELL No. No he must have gone somewhere else outside Holland. BARCLAY Dr Tressell thank you for joining us. Carolyn Atkinson is still here, Carolyn is this ban going to stay do you think? ATKINSON Well the ban at the moment runs through to Monday evening 5 o'clock, the Dutch Inspectorate has already - have already, I should say, asked the Minister of Health to renew that order and that is expected to happen. As for this British man that Dr Tressell was talking about, he's had the stem cell treatment, Fryson Vandebeek, from the Dutch Inspectorate, who we heard from earlier, has given her reaction to the allegations, she's basically saying that they will investigate this further because they need to be sure that he hasn't had treatment after the ban. BARCLAY Carolyn Atkinson thank you for joining us. Back to the You and Yours homepage The BBC is not responsible for external websites |
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