Guest guest Posted January 6, 2011 Report Share Posted January 6, 2011 full thing http://whale.to/vaccine/wakefield23.html Video transcripts: Dr Wakefield - In His own words 2010 April Question 1: Part 1 Why have you been called to the GMC ? Part 2 Access to Justice Part 3 Professor Zuckerman Forgets Part 4 Dr Armstrong and the BMA Part 5: The Whistle-blower Part 6 Government liability Question 2: Conflicts of Interest and Dishonesty? Question 3: Dr Salisbury calls the the GMC ! Question 1: Part 1 Why have you been called to the GMC ? Why is this hearing being held at all in front of the regulatory body of the UK, and who bought the case and what is the case? The case, it seems, on the face of it, was brought by a single complaint by a freelance journalist who had been working for the Sunday Times, and others, and had been trying to uncover some misdemeanour on our behalf at the Royal free in the investigation of children with regressive autism, with bowel problems, many of the parents of whom said their children regressed after the Measles, Mumps, Rubella vaccine. And I will just take you back, because when I began this work in 1995 parents approached me and said-- my child developed perfectly normally, they had their MMR vaccine, I wasn't anti-vaccine, I took them along, they had their vaccine according to the routine schedule and then the lights went out, eyes glazed over, they lost speech, they lost interaction, they stopped playing with their siblings, they never smiled, they were grizzly, and eventually having lost skills and become mute and self injurious, they were diagnosed with autism or atypical autism. And I said, I am terribly sorry, I know nothing about autism, how can I possibly help, and they said, well, my child has terrible bowel problems, diarrhoea, pain, I know they are in pain, they can't tell me they are in pain because they have lost the ability to speak, but I know they are in pain, my instinct as a mother tells me my child is in pain, they are screaming, they are drawing their knees up to their chest, particularly bad when they have their bowel opened. Losing weight, failing to thrive, and the doctor says your child is autistic, that is just the way it is. Well, that is not just the way it is, that is not what autism is, these are children who are sick, who are clearly unwell. So we put the autism to one side and we said how do we manage these children if they had these symptoms and they were developmentally normal and we would investigate? And so we decided we would, over the course of many months, we put together a protocol, a clinical protocol, for the investigation of these children. What investigations do these children need in order for us to unearth the origins of their problem, for example, do we do a colonoscopy to investigate their bowel problems, are the bowel problems linked to the behaviour? Because the parents were reporting us--when my child's bowel is bad, when they are in pain, their behaviour is terrible, they can't concentrate, they are at their worst autistically, and their autistic mannerisms get worse when their intestine is bad and gets better when their intestine improves, and this was intriguing to us as gastroenterologists because we had seen this before in other gastrointestinal diseases. Gastrointestinal inflammable diseases like Celiac disease, or bacterial overgrowth when you lose a lot of your small intestinal, and you are just left with a little bit behind where bowel bacteria overgrowth leads to deterioration in behaviour, what is called encephalopathy, and often even progressing to coma, and the way you treat that is to treat the bowel, get rid of the bugs in the bowel and the behaviour improves. So we had seen it before, this gut-brain link, something in the bowel affecting the brain, and treating the bowel helping the brain, so why was this different? Was this a similar process? Was, for example, some form of intoxication, some bacterial by-product coming from the intestine and injuring the brain, rather like drinking alcohol, you drink alcohol, it gets to the brain, injures the brain, affects the brain, affects behaviour, and so this was no different, it is not difficult, it is not rocket science, very very straightforward. Something going on in the gut primarily, and injures the brain, so this was an entirely reasonable idea to look at. The other thing is these children had regressed in the face of a viral insult, they had been given a live viral vaccine, they had been given viruses which were known to be able to infect the brain and cause inflammation in the brain, for example autism. So it was entirely appropriate that they would undergo a series of investigations, in other words could we find in a laboratory setting evidence of measles virus in the inflamed intestine. Research. So combining as we should do in an academic institute like the Royal Free, clinical investigation with research. And we progressed through the process thereby refining the clinical investigation. This is necessary, that isn't, this is telling us something, this isn't, out that goes, and then refining the process, so we were getting the maximum amount of information from investigating these children for the minimum inconvenience and risk to the child, and that is just good medicine. So during this process I was approached by some lawyers who were acting on behalf of these children, investigating the parental claim that their child had regressed, disappeared, become autistic after a vaccine. And they said to me, would you help us? You have an interest in Crohn's disease and measles virus, measles vaccine. We are now seeing these new children, what do you think, can you help us in this process? And I thought about it long and hard, and I decided that I would, and I later wrote to my colleagues explaining my reason for doing so, and my feeling was this, it was very straightforward. Vaccination is designed for the greater good, to protect the majority and it does so at the expense of a minority, and that minority of children are those that are damaged by the vaccine, and we don't know the size of the number because it has never been investigated properly, but nonetheless, even if you accept that is a permissible ethical approach, that we can protect the majority at the expense of the minority, then that minority are a group of children who have paid the price for protecting the rest of society, and therefore society has an absolute moral and ethical obligation to care for those children for the rest of their lives, period. That is it, there is no escaping that moral imperative, and yet to acknowledge those children in a public health setting is to raise doubts about the safety of vaccines and therefore it is much better to put them in a corner and forget about them, to pretend they simply don't exist. That is what had happened to these children. The studies that had been designed to look at safety had been designed in such a way as they would never capture these children, nor did anyone want to capture them, nor was anyone interested in the parents story when they said my child has regressed after a vaccine. They were just put in a corner, told it couldn't happen and never investigated, and that was absolutely unacceptable. Part 2 Access to Justice So, the other thing that happened, around the same time, is a parent called me, she is the mother of two autistic children from the Midlands, and she was an older parent, and she had a husband who was older than she was. He was infirm and she herself had arthritis. And she called me one day and she said, doctor Wakefield please don't be judgmental, don't judge me harshly she said, but when I die, I am taking my children with me, and I thought long and hard about that, and I wasn't in any way judgmental, in fact quite the opposite, I was struck. She said to me, Dr Wakefield, no one else cares about my children, I am the only person who loves them and when I die or become infirm to the extent that I can no longer care for them, they are going to be lost, they are going to be on the street and they are going to die on the street because the world doesn't care. And she was right, she was absolutely right, there was nothing for these children, and you will know that in the Thatcher era all the long stay institutions, the old asylums were closed down and turned into luxury apartments and there is nothing left. It is care in the community, what does that mean? It just means shoving people with long term mental disabilities out into the community where they can injure themselves or injure other people, or whatever. Who knows, who follows them, who cares? And that was the future for these children, so, I decided at that point that I would help the lawyers, because if nothing else I was in a position to look at this scientifically, objectively and provide an answer that would, or would not take this story forward, but would nonetheless give these children access to the due process of justice, and that is what they had been denied. So it was about access to justice and surely that cannot be denied anyone, you would think, in a civilised society. So the lawyers asked me what we should do, how would you go about in a scientific context, taking this to the next step, determining whether this temporal association that the mother has made between a child's exposure to this vaccine and regression, how would you then further link that if possible to the virus, and I said the bowel disease that we have seen in these children and the Crohn's disease looks like an infectious disease and you would look for evidence of the virus in sites of infection or obvious swelling of the lymph glands, there is one site in the intestine, it is like swelling of the tonsils when you get a sore throat, you would look in the tonsil for the organism that was causing it. So if you have got swelling of the lymph glands in the intestine, look in there for the evidence of the virus, and measles virus, and measles was a virus that was known to cause this kind of swelling of the intestinal lymph glands. So it made logical sense to look in those areas and so we set up a study. I was asked to design a study that would take this to that level, that we would get funding from the Legal Aid Board (LAB), hypothetically, and then we would look for evidence of the virus in the intestine, and after a series of exchanges, and a protocol was prepared, we received acknowledgement of funding form the LAB to conduct that study. It is was negative it was negative, if it was positive it was positive, either way it got published. It was not designed to produce a particular answer, it was just designed to produce an answer, is the virus there, or not? It didn't make it causation but it was a piece, a crucial piece of the jigsaw that took it to the next level. Part 3 Professor Zuckerman Forgets [ Zuckerman] Interestingly, the Dean of the medical school, Prof Ari Zuckerman, world renowned virologist, expert in Hepatitis B, worked very closely with the WHO, was deeply involved with hepatitis B vaccination, a great advocate of hepatitis B vaccination, different story, but nonetheless, there he was in the general apparatchik of the vaccine advocates. And he said to me that he had been contacted by the Department of Health and a certain members of the Royal College of Child Health who had made him aware of this funding, and I said yes, this is a grant we got from them and perfectly respectable, and we are conducting the science, and he said there was a conflict of interest, a clear conflict of interest, and I couldn't understand it, why? Why was there a conflict of interest? I had no conflict of interest, I was asked to take this grant to conduct a piece of science and give an answer. That wasn't a conflict of interest. The funding would be disclosed in the paper that wrote up the science, the funding came from the Legal Aid Board, but beyond that where was the conflict? Anyway, I wrote back to him and said your suggestion that there is a conflict of interest has exercised my mind greatly over the last several months and I cannot see where it lies, and i laid out for him the context of my discussions with the lawyers and the work that was to be done, and he wrote back to me and couldn't precisely define what the conflict was, but talked about if a legal action was anticipated, and preliminary discussions had already taken place then there was a conflict, and it didn't really make a lot of sense to me. I wrote back to him again and reiterated that we had been asked to do a piece of science that wasn't seeking a particular answer. I wouldn't have got involved in the first place if there was any effort of coercion or demanding that......we own the data, the lawyers didn't own it. We would do what we felt was scientifically appropriate, and I had every faith in the lawyers, they seemed very concerned, genuinely concerned about these children, they weren't in any way ambulance chasers but nonetheless there was some clear problem for the Dean in this, and he ultimately refused to take the money, and I said send it back, we don't want it, if you are not going to let us do this, we won't do it. Anyway, one of my colleagues said we will put it into an account at the hospital, a charitable account...and see if that is OK. So we did, now, interestingly the Dean has just appeared as a witness on behalf of the prosecution at the GMC. Professor Ari Zuckerman, now 7 years retired and clearly deeply frustrated that he should be dragged out of retirement to have to give his evidence in this case, but nonetheless his first foray was to say, yes, when this money was transferred by the accountant of the Royal Free Medical School it was too late, I didn't know about it, it had already happened, I couldn't stop it. It is interesting that he actually signed the cheque for the transfer. Surprising that, given the fact that it had already happened by the time he knew about it, nonetheless an interval of 11 years can cloud ones mind, memory of things. There we are. But that was the first error he made. Part 4 Dr Armstrong and the BMA What he disclosed, interestingly, to me during that period was that he had written to the ethics committee of the British Medial Association (BMA), to take their advice, how to deal with this perplexing issue that was causing him concern about conflicts of interest that has was really unable to articulate to me. So he wrote to Dr Armstrong at the BMA ethics committee to ask their opinion, and in it unbeknown to me at the time, he had said he had been contacted by the Department of Health who said to him that the government stood to be sued by the parents of children affected by MMR or apparently affected by MMR vaccine, and that this to him was a conflict of interest. That government was going to be sued. Do you understand, I came into this with the lawyers believing the case was against the vaccine manufacturers, the government didn't even come into it, but he was clearly under the impression that the government were going to be sued. He also said that this may be embarrassing for the medical school. Now, we were never party to the ultimate response of Dr Armstrong of the BMA. We were never told about it. All we did when he wrote back to me is to say you will know that I have taken advice on this matter from the BMA and leave it that, as though the BMA had ruled completely against it. When in fact we got the documents, as we did do as part of the disclosure for the GMC, there it was, the letter from Dr Armstrong, not only endorsing the fact this study could and should be done because it was morally and ethically proper that it should be done, but that not to do it because it was embarrassing to an institute or because it meant the government might be sued was not a sound moral argument. His words. So in other words the BMA ethics committee said this is fine. It said actions of this kind or research of this kind is often funded by a group with a particular interest. Of course they are, the Multiple Sclerosis Society funds research for MS in the hope that it can make patients better. So here we have another group of people with a vested interest funding a piece of research. As long as it is ethical, and as long as it is conducted in a way that it is published, whether it is positive or negative, then that is fine. Nonetheless Prof Zuckerman did not get the answer he wanted. He never disclosed that to us, he just kept beating us over the head with the certain knowledge that he had contacted the BMA and they had given him an opinion. Part 5: The Whistle-blower ....................Dr Alistair who was from the ish dept of health, and Dr had been seconded onto the JCVI, effectively from Canada, and he had been brought in, at least in part, to advise on the introduction of MMR vaccine. The experience in Canada was that they introduced a vaccine which contained a mumps component made up of a strain of the vaccine called Urabe, which was originally generated in Japan and they had run into problems with this vaccine. It produced meningitis in children (1:43). the mumps virus was identified in the brain of the children and the vaccine was pulled in Canada, it was pulled, it was stopped in 1997 (1:53), nonetheless this was the vaccine that was intended to be introduced into the UK a year later in 1988. They changed the name, but the vaccine was identical, so it had gone from Trivirix to Pluserix in the UK, an identical vaccine that had already been withdrawn for safety reasons, in Canada. Now advised the JCVI not to introduce this vaccine because it was not safe. He was overruled. He said if you are going to introduce it then you should have active surveillance. That is doctors or people going out and asking doctors--have you seen and cases of the following in the past month, not waiting for doctors to spontaneously report. Spontaneous reporting picks up 1-2% of those adverse reactions.....It is totally inadequate but they were totally overruled, not active surveillance (3:02). So they were going to intro a vaccine that has been withdrawn in other countries, known to be unsafe and they were going to have no active surveillance (3:08) for possible adverse events in this country. Now this was done, he said, for competitive pricing reasons. The strain of the vaccine that contained the dangerous mumps component was approx. 1/4 the price of the American MMRII made by Merck. There had been no reports of meningitis using the Merck vaccine which contained a strain of mumps called Jeryl Lynn....So what we had was a cheaper vaccine that was known to be dangerous (3:47), so when the vaccines were licensed or the proposal to licence these vaccines, the JCVI or members of that committee (4:0) went to Kline Beecham (SKB) and said we want your vaccine. SKB said we are not happy about it because this has already been withdrawn in Canada, it has got this mumps component in it which is dodgy They said if we are going to do it then we want an indemnity, we want indemnity from prosecution for damage to children on the basis (4:27) of the receipt of the vaccine, and it appears that indemnity was granted, and told us about this (4:33), and he said at the meeting, the girl there from SKB said we are immunising the children and the government is immunising us. So the vaccine was produced, licensed, given, and cases of meningitis started to appear. they were recorded and documented in the minutes of the JCVI which are now available on line and have been obtained by us as part of our investigation. More and more cases began to be reported, the ish dept' withdrew this vax, certain health areas rejected the Urabe containing vaccine but still the JCVI continued with it. There was no withdrawal of this vaccine until finally a study was grudgingly done in Nottingham where they found a much higher risk of meningitis with this vaccine (5:33) than had previously been predicted by passive surveillance, and the vaccine was withdrawn overnight, and it was only withdrawn overnight because it was leaked to the press. It appeared in a newspaper and suddenly the vaccine was pulled. So a dangerous vaccine, a knowingly dangerous vaccine was introduced and ultimately proven to be dangerous and had to be withdrawn (6:00) in 1992. Part 6 Government liability The two of the three vaccine brands that were introduced in 1988 had to be withdrawn for safety reasons and yet Dr Salisbury in his statement to the GMC sums up by saying this is a vaccine with an exemplary safety record. Well, if that is his idea of an excellent safety record then we have a very different perception he and I of vaccine safety. And so we come full circle now because it turns out the Dean was right. Ari Zuckerman was right. Based upon the information he got, he says (probably from Dr Salisbury way back when these parents started coming to us in 1996/7), that it was the government that was going to be sued. I thought it was going to be the drug companies, but it wasn't. Why was it the government? Because the government had given the drug companies an indemnity against harm and so this is why we are here, this is what this is all about (1:19), this is what this whole GMC affair and effort to descredit doctors questioning the safety of the MMR vaccine has come about because of an indemnity given to the drug companies all those years ago for the introduction of an unsafe vaccine by perhaps just a few members of the department of Health or recommended by the Dept of Health to the Government such that a vaccine (1:53) was introduced and when you ask now, and people have asked, was there an indemnity? is there an indemnity? the answer is catagorically, from Salisbury, time and time again, there was no indemnity (2:07), no letter of comfort, nothing at all....and yet in the minutes of the JCVI, as late on in this story as 1997, there is an entry there that says (it talks about the various brands of vaccine that are available) SKB continued to sell the Urabe strain without liablity (2:39), there it is, in black and white in their own document. I have been every which way around that statement and cannot reconcile it to anything else other than that there was and remains an indemnity, so I am afraid (3:00) that this is really the origins of this whole process and the hope that my colleagues and I be discredited before this information ever becomes public, and in an effort to protect that original decision, that original flawed decision and the consequences that have flowed from it, then we find ourselves in this position, and that is fine but it is not going to stop the truth coming out, and you would think under those circumstances having withdrawn this vaccine (3:37) in Australia, Canada and Japan, and the UK that that would be it, they would get rid of it, because it is not safe, but no (3:46) they go on making it, and what do they do with it, they ship it out to the third world, and there was a mass vaccine campaign in Brazil in the 90's where they gave the great majority of Brazilian children a re-vaccination with MMR, during a very short space of time, with the Urabe containing vaccine, which they knew to be dangerous, which produced an epidemic of meningitis (4:16), a huge peak in the numbers of cases, and there was a paper written about it after, and one of the points in the discussion in the paper was perhaps it was not a good idea, in effect, to do mass vaccination campaigns because it produced the true incidence of side effects to a vaccine. Well, who wrote that, who in God's name wrote that? So this is, if you like, the morality of the people we are dealing with. Why is that vax even on the shelf? Why is it being sold at cut rate price to third world countries? What is the thinking behind this? Because it is certainly not a moral imperative, it must be a commercial one. So that's why we are here and that is why we will remain here, and continue to fight this (5:12) kind of thing, because you can't treat people as expendable. You can't damage them and put them to one side. Adolph Hitler in Mein Kampf once wrote the greater truth excludes the lesser truth. In the world or mind of people like Adolph Hitler and that kind of thinking failed in the 1940s and it is going to fail now. You cannot treat people in a civilised society as expendable. Yes, there may be an argument for a vaccine programme that protects the greater good but that does not mean that you can render those who are damaged, just consign them to the dustcart because they are an inconvenience, or their (6:08) mere presence undermines public confidence, better to keep them hidden out the way and there are too many of these children now, they won't be hidden away, and parents are getting very very angry, and they have every right to be angry, and the truth is going to come out, and it is going to be a very very painful truth when it does come out. The tragedy is, it is going to damage public confidence in vaccine policy across the board because people are going to say we don't believe you any more, we don't trust you, you lied to us and when that happens all vaccination policy is compromised, the whole pillar of public health comes tumbling down and a lot of trouble is going to ensue as you are going to deal with a population who are not protected from these infections and we are going to run into big problems, and that responsibility for that lays at the door of the public health figures and their commercial partners who have allowed this to happen. Question 2: Conflicts of Interest and Dishonesty? There have been some slightly difficult moments about differences of opinion, for example with Horton over conflicts of interests...the Lancet statement on conflict is: 'anything that would embarrass you if it were later disclosed', and my involvement with the Legal Aid Board didn't embarrass me at all, and it wasn't relevant, in my opinion, to disclose it in the Lancet paper because they didn't fund any of the Lancet paper, they funded a subsequent virological study, as was always intended, but it had been misrepresented in the media that they had funded the Lancet study, and it wasn't disclosed, and this was the perception Horton originally had, and when I was asked about this by him way back in 2004 I said, no, they didn't fund the study at all, they funded a separate study, and he said 'well in that case it could be perceived as a potential conflict of interest', and I said where did that come from? The statement as I read it in the Lancet, the requirement is to 'disclose things that might embarrass you if they emerge later'. And it was interesting because within that document, which was self contained, anyone writing a paper for the Lancet would just need to read that and the actual statement is the test of conflict of interest in the Lancet is an easy one, 'anything that would embarrass you', and so you don't go beyond that, it is a self contained document, why would you go any further, but there is a website flagged up in there where you can go and there is a more broader description of conflict of interest there which does include potential or perceived conflicts of interest, which no one ever went to. Why would you do it? You have got it in front of you. Now there is a very big difference. Anything that would embarrass you is the active move, OK, it is what would embarrass me, so I can think what would embarrass me, and I can make a decision about that. What others might perceive to be a conflict of interest is myriad, it goes on forever. You have to put yourself in the third person and think what might someone else with their various views and biases construe to be a conflict of interest, and that is massive, where does that end? So that is a huge conceptual leap in terms as to what you would disclose, and there was no formal way for doing it at the time. Now you have a document where you fill in the boxes, saying no shares, no this, no that. That is very straight foreword, but in those days it wasn't, it was highly ambiguous, and it was always my intention, and always was disclosed, when there was a direct funding for a study, a grant giving body, or in this case the Legal Aid Board, and so in the viral study it was disclosed, 'this study was supported in part by the Legal Aid Board, and Dr Wakefield is acting as an expert in the MMR litigation', that is an easy one as it goes, but in the Lancet study I felt no need to disclose it at all, and neither did any of my colleagues who knew that I was involved with the Legal aid Board on behalf of some of these children. So that was a difficult moment but it was a difference of opinion, he thought I should have disclosed it. I felt at the time that I didn't, now in retrospect, having seen this new document about perceived conflict I can see that it should have been disclosed, but there was no dishonesty, and he was good enough to say there was no intent to deceive, 'when Dr Wakefield was asked about it he was entirely open, he said yes there was this grant'. We got into an argument and debate about what was or wasn't a conflict of interest, but there was absolutely no intent to deceive and the charge is dishonesty, so he was extremely helpful in this as much he said, no this was not dishonest, this was a genuine difference of opinion, and so that then largely resolved. Question 3: Dr Salisbury calls the the GMC ! Where does it leave the GMC if you are not guilty? Very good question on a very broad front. They have some tough decisions to make. One on the level of the case itself, and have they mis-instructed their experts, are they going to have to retrench in a different set of charges. They have to take time to structure those charges and get a response from their experts. Are they going to be allowed to do that, I don't know, but it must be becoming obvious to them now that much of the original information they were given, was, had been, misconstrued, and basing their charges on that information has been in error. At another level they are under big pressure from the Department of Health, and Salisbury in particular has been calling them on a regular basis urging them to prosecute this case more vigorously against me, be nastier, be meaner, throw more in, and I know this because we get sent the unused material, and so I took the opportunity (he didn't know this, I mean you get all the telephone conversations, all the conversation between people, all the draft reports which is an interesting advantage to us), so I was able to write to Salisbury and was able to say I am now in a position to have read the unused material from the GMC, and I note your entreaties to them....He was furious, he contacted the GMC and said: " I didn't know they were going to get the unused material...you never told me, this is a disgrace! " And the wonderful thing about that is that we get the documentation of that telephone conversation as well (laughs). So, you can see they are under a great deal of political pressure to prosecute this case and it is interesting in the public domain Salisbury has said we don't want this to be seen as a vendetta on behalf of the Department of Health. So, mixed messages. PART TWO. The other dilemma they have is who do they represent in the end? Because the GMC have historically stood for the patient, the patients rights, the patients protection from, for example, medical malpractice. Well, who do they stand for now because we stand for the patients. Everything we have done is in the best interests of the children. What they are representing and prosecuting is not on behalf of the children no parent has complained against us, but on behalf of the Department of Health, on behalf of the new kid on the block, 'the greater good.' So here we have a body who has traditionally represented the patient, the victim, if you like, against the medical profession or against medical malpractice. Now they are defending the diktat of public health against the rights of the individual. So they are in a real quandary, or if they are not they should be, about quite who they represent, because I know who I represent--the individual patient. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 6, 2011 Report Share Posted January 6, 2011 full thing http://whale.to/vaccine/wakefield23.html Video transcripts: Dr Wakefield - In His own words 2010 April Question 1: Part 1 Why have you been called to the GMC ? Part 2 Access to Justice Part 3 Professor Zuckerman Forgets Part 4 Dr Armstrong and the BMA Part 5: The Whistle-blower Part 6 Government liability Question 2: Conflicts of Interest and Dishonesty? Question 3: Dr Salisbury calls the the GMC ! Question 1: Part 1 Why have you been called to the GMC ? Why is this hearing being held at all in front of the regulatory body of the UK, and who bought the case and what is the case? The case, it seems, on the face of it, was brought by a single complaint by a freelance journalist who had been working for the Sunday Times, and others, and had been trying to uncover some misdemeanour on our behalf at the Royal free in the investigation of children with regressive autism, with bowel problems, many of the parents of whom said their children regressed after the Measles, Mumps, Rubella vaccine. And I will just take you back, because when I began this work in 1995 parents approached me and said-- my child developed perfectly normally, they had their MMR vaccine, I wasn't anti-vaccine, I took them along, they had their vaccine according to the routine schedule and then the lights went out, eyes glazed over, they lost speech, they lost interaction, they stopped playing with their siblings, they never smiled, they were grizzly, and eventually having lost skills and become mute and self injurious, they were diagnosed with autism or atypical autism. And I said, I am terribly sorry, I know nothing about autism, how can I possibly help, and they said, well, my child has terrible bowel problems, diarrhoea, pain, I know they are in pain, they can't tell me they are in pain because they have lost the ability to speak, but I know they are in pain, my instinct as a mother tells me my child is in pain, they are screaming, they are drawing their knees up to their chest, particularly bad when they have their bowel opened. Losing weight, failing to thrive, and the doctor says your child is autistic, that is just the way it is. Well, that is not just the way it is, that is not what autism is, these are children who are sick, who are clearly unwell. So we put the autism to one side and we said how do we manage these children if they had these symptoms and they were developmentally normal and we would investigate? And so we decided we would, over the course of many months, we put together a protocol, a clinical protocol, for the investigation of these children. What investigations do these children need in order for us to unearth the origins of their problem, for example, do we do a colonoscopy to investigate their bowel problems, are the bowel problems linked to the behaviour? Because the parents were reporting us--when my child's bowel is bad, when they are in pain, their behaviour is terrible, they can't concentrate, they are at their worst autistically, and their autistic mannerisms get worse when their intestine is bad and gets better when their intestine improves, and this was intriguing to us as gastroenterologists because we had seen this before in other gastrointestinal diseases. Gastrointestinal inflammable diseases like Celiac disease, or bacterial overgrowth when you lose a lot of your small intestinal, and you are just left with a little bit behind where bowel bacteria overgrowth leads to deterioration in behaviour, what is called encephalopathy, and often even progressing to coma, and the way you treat that is to treat the bowel, get rid of the bugs in the bowel and the behaviour improves. So we had seen it before, this gut-brain link, something in the bowel affecting the brain, and treating the bowel helping the brain, so why was this different? Was this a similar process? Was, for example, some form of intoxication, some bacterial by-product coming from the intestine and injuring the brain, rather like drinking alcohol, you drink alcohol, it gets to the brain, injures the brain, affects the brain, affects behaviour, and so this was no different, it is not difficult, it is not rocket science, very very straightforward. Something going on in the gut primarily, and injures the brain, so this was an entirely reasonable idea to look at. The other thing is these children had regressed in the face of a viral insult, they had been given a live viral vaccine, they had been given viruses which were known to be able to infect the brain and cause inflammation in the brain, for example autism. So it was entirely appropriate that they would undergo a series of investigations, in other words could we find in a laboratory setting evidence of measles virus in the inflamed intestine. Research. So combining as we should do in an academic institute like the Royal Free, clinical investigation with research. And we progressed through the process thereby refining the clinical investigation. This is necessary, that isn't, this is telling us something, this isn't, out that goes, and then refining the process, so we were getting the maximum amount of information from investigating these children for the minimum inconvenience and risk to the child, and that is just good medicine. So during this process I was approached by some lawyers who were acting on behalf of these children, investigating the parental claim that their child had regressed, disappeared, become autistic after a vaccine. And they said to me, would you help us? You have an interest in Crohn's disease and measles virus, measles vaccine. We are now seeing these new children, what do you think, can you help us in this process? And I thought about it long and hard, and I decided that I would, and I later wrote to my colleagues explaining my reason for doing so, and my feeling was this, it was very straightforward. Vaccination is designed for the greater good, to protect the majority and it does so at the expense of a minority, and that minority of children are those that are damaged by the vaccine, and we don't know the size of the number because it has never been investigated properly, but nonetheless, even if you accept that is a permissible ethical approach, that we can protect the majority at the expense of the minority, then that minority are a group of children who have paid the price for protecting the rest of society, and therefore society has an absolute moral and ethical obligation to care for those children for the rest of their lives, period. That is it, there is no escaping that moral imperative, and yet to acknowledge those children in a public health setting is to raise doubts about the safety of vaccines and therefore it is much better to put them in a corner and forget about them, to pretend they simply don't exist. That is what had happened to these children. The studies that had been designed to look at safety had been designed in such a way as they would never capture these children, nor did anyone want to capture them, nor was anyone interested in the parents story when they said my child has regressed after a vaccine. They were just put in a corner, told it couldn't happen and never investigated, and that was absolutely unacceptable. Part 2 Access to Justice So, the other thing that happened, around the same time, is a parent called me, she is the mother of two autistic children from the Midlands, and she was an older parent, and she had a husband who was older than she was. He was infirm and she herself had arthritis. And she called me one day and she said, doctor Wakefield please don't be judgmental, don't judge me harshly she said, but when I die, I am taking my children with me, and I thought long and hard about that, and I wasn't in any way judgmental, in fact quite the opposite, I was struck. She said to me, Dr Wakefield, no one else cares about my children, I am the only person who loves them and when I die or become infirm to the extent that I can no longer care for them, they are going to be lost, they are going to be on the street and they are going to die on the street because the world doesn't care. And she was right, she was absolutely right, there was nothing for these children, and you will know that in the Thatcher era all the long stay institutions, the old asylums were closed down and turned into luxury apartments and there is nothing left. It is care in the community, what does that mean? It just means shoving people with long term mental disabilities out into the community where they can injure themselves or injure other people, or whatever. Who knows, who follows them, who cares? And that was the future for these children, so, I decided at that point that I would help the lawyers, because if nothing else I was in a position to look at this scientifically, objectively and provide an answer that would, or would not take this story forward, but would nonetheless give these children access to the due process of justice, and that is what they had been denied. So it was about access to justice and surely that cannot be denied anyone, you would think, in a civilised society. So the lawyers asked me what we should do, how would you go about in a scientific context, taking this to the next step, determining whether this temporal association that the mother has made between a child's exposure to this vaccine and regression, how would you then further link that if possible to the virus, and I said the bowel disease that we have seen in these children and the Crohn's disease looks like an infectious disease and you would look for evidence of the virus in sites of infection or obvious swelling of the lymph glands, there is one site in the intestine, it is like swelling of the tonsils when you get a sore throat, you would look in the tonsil for the organism that was causing it. So if you have got swelling of the lymph glands in the intestine, look in there for the evidence of the virus, and measles virus, and measles was a virus that was known to cause this kind of swelling of the intestinal lymph glands. So it made logical sense to look in those areas and so we set up a study. I was asked to design a study that would take this to that level, that we would get funding from the Legal Aid Board (LAB), hypothetically, and then we would look for evidence of the virus in the intestine, and after a series of exchanges, and a protocol was prepared, we received acknowledgement of funding form the LAB to conduct that study. It is was negative it was negative, if it was positive it was positive, either way it got published. It was not designed to produce a particular answer, it was just designed to produce an answer, is the virus there, or not? It didn't make it causation but it was a piece, a crucial piece of the jigsaw that took it to the next level. Part 3 Professor Zuckerman Forgets [ Zuckerman] Interestingly, the Dean of the medical school, Prof Ari Zuckerman, world renowned virologist, expert in Hepatitis B, worked very closely with the WHO, was deeply involved with hepatitis B vaccination, a great advocate of hepatitis B vaccination, different story, but nonetheless, there he was in the general apparatchik of the vaccine advocates. And he said to me that he had been contacted by the Department of Health and a certain members of the Royal College of Child Health who had made him aware of this funding, and I said yes, this is a grant we got from them and perfectly respectable, and we are conducting the science, and he said there was a conflict of interest, a clear conflict of interest, and I couldn't understand it, why? Why was there a conflict of interest? I had no conflict of interest, I was asked to take this grant to conduct a piece of science and give an answer. That wasn't a conflict of interest. The funding would be disclosed in the paper that wrote up the science, the funding came from the Legal Aid Board, but beyond that where was the conflict? Anyway, I wrote back to him and said your suggestion that there is a conflict of interest has exercised my mind greatly over the last several months and I cannot see where it lies, and i laid out for him the context of my discussions with the lawyers and the work that was to be done, and he wrote back to me and couldn't precisely define what the conflict was, but talked about if a legal action was anticipated, and preliminary discussions had already taken place then there was a conflict, and it didn't really make a lot of sense to me. I wrote back to him again and reiterated that we had been asked to do a piece of science that wasn't seeking a particular answer. I wouldn't have got involved in the first place if there was any effort of coercion or demanding that......we own the data, the lawyers didn't own it. We would do what we felt was scientifically appropriate, and I had every faith in the lawyers, they seemed very concerned, genuinely concerned about these children, they weren't in any way ambulance chasers but nonetheless there was some clear problem for the Dean in this, and he ultimately refused to take the money, and I said send it back, we don't want it, if you are not going to let us do this, we won't do it. Anyway, one of my colleagues said we will put it into an account at the hospital, a charitable account...and see if that is OK. So we did, now, interestingly the Dean has just appeared as a witness on behalf of the prosecution at the GMC. Professor Ari Zuckerman, now 7 years retired and clearly deeply frustrated that he should be dragged out of retirement to have to give his evidence in this case, but nonetheless his first foray was to say, yes, when this money was transferred by the accountant of the Royal Free Medical School it was too late, I didn't know about it, it had already happened, I couldn't stop it. It is interesting that he actually signed the cheque for the transfer. Surprising that, given the fact that it had already happened by the time he knew about it, nonetheless an interval of 11 years can cloud ones mind, memory of things. There we are. But that was the first error he made. Part 4 Dr Armstrong and the BMA What he disclosed, interestingly, to me during that period was that he had written to the ethics committee of the British Medial Association (BMA), to take their advice, how to deal with this perplexing issue that was causing him concern about conflicts of interest that has was really unable to articulate to me. So he wrote to Dr Armstrong at the BMA ethics committee to ask their opinion, and in it unbeknown to me at the time, he had said he had been contacted by the Department of Health who said to him that the government stood to be sued by the parents of children affected by MMR or apparently affected by MMR vaccine, and that this to him was a conflict of interest. That government was going to be sued. Do you understand, I came into this with the lawyers believing the case was against the vaccine manufacturers, the government didn't even come into it, but he was clearly under the impression that the government were going to be sued. He also said that this may be embarrassing for the medical school. Now, we were never party to the ultimate response of Dr Armstrong of the BMA. We were never told about it. All we did when he wrote back to me is to say you will know that I have taken advice on this matter from the BMA and leave it that, as though the BMA had ruled completely against it. When in fact we got the documents, as we did do as part of the disclosure for the GMC, there it was, the letter from Dr Armstrong, not only endorsing the fact this study could and should be done because it was morally and ethically proper that it should be done, but that not to do it because it was embarrassing to an institute or because it meant the government might be sued was not a sound moral argument. His words. So in other words the BMA ethics committee said this is fine. It said actions of this kind or research of this kind is often funded by a group with a particular interest. Of course they are, the Multiple Sclerosis Society funds research for MS in the hope that it can make patients better. So here we have another group of people with a vested interest funding a piece of research. As long as it is ethical, and as long as it is conducted in a way that it is published, whether it is positive or negative, then that is fine. Nonetheless Prof Zuckerman did not get the answer he wanted. He never disclosed that to us, he just kept beating us over the head with the certain knowledge that he had contacted the BMA and they had given him an opinion. Part 5: The Whistle-blower ....................Dr Alistair who was from the ish dept of health, and Dr had been seconded onto the JCVI, effectively from Canada, and he had been brought in, at least in part, to advise on the introduction of MMR vaccine. The experience in Canada was that they introduced a vaccine which contained a mumps component made up of a strain of the vaccine called Urabe, which was originally generated in Japan and they had run into problems with this vaccine. It produced meningitis in children (1:43). the mumps virus was identified in the brain of the children and the vaccine was pulled in Canada, it was pulled, it was stopped in 1997 (1:53), nonetheless this was the vaccine that was intended to be introduced into the UK a year later in 1988. They changed the name, but the vaccine was identical, so it had gone from Trivirix to Pluserix in the UK, an identical vaccine that had already been withdrawn for safety reasons, in Canada. Now advised the JCVI not to introduce this vaccine because it was not safe. He was overruled. He said if you are going to introduce it then you should have active surveillance. That is doctors or people going out and asking doctors--have you seen and cases of the following in the past month, not waiting for doctors to spontaneously report. Spontaneous reporting picks up 1-2% of those adverse reactions.....It is totally inadequate but they were totally overruled, not active surveillance (3:02). So they were going to intro a vaccine that has been withdrawn in other countries, known to be unsafe and they were going to have no active surveillance (3:08) for possible adverse events in this country. Now this was done, he said, for competitive pricing reasons. The strain of the vaccine that contained the dangerous mumps component was approx. 1/4 the price of the American MMRII made by Merck. There had been no reports of meningitis using the Merck vaccine which contained a strain of mumps called Jeryl Lynn....So what we had was a cheaper vaccine that was known to be dangerous (3:47), so when the vaccines were licensed or the proposal to licence these vaccines, the JCVI or members of that committee (4:0) went to Kline Beecham (SKB) and said we want your vaccine. SKB said we are not happy about it because this has already been withdrawn in Canada, it has got this mumps component in it which is dodgy They said if we are going to do it then we want an indemnity, we want indemnity from prosecution for damage to children on the basis (4:27) of the receipt of the vaccine, and it appears that indemnity was granted, and told us about this (4:33), and he said at the meeting, the girl there from SKB said we are immunising the children and the government is immunising us. So the vaccine was produced, licensed, given, and cases of meningitis started to appear. they were recorded and documented in the minutes of the JCVI which are now available on line and have been obtained by us as part of our investigation. More and more cases began to be reported, the ish dept' withdrew this vax, certain health areas rejected the Urabe containing vaccine but still the JCVI continued with it. There was no withdrawal of this vaccine until finally a study was grudgingly done in Nottingham where they found a much higher risk of meningitis with this vaccine (5:33) than had previously been predicted by passive surveillance, and the vaccine was withdrawn overnight, and it was only withdrawn overnight because it was leaked to the press. It appeared in a newspaper and suddenly the vaccine was pulled. So a dangerous vaccine, a knowingly dangerous vaccine was introduced and ultimately proven to be dangerous and had to be withdrawn (6:00) in 1992. Part 6 Government liability The two of the three vaccine brands that were introduced in 1988 had to be withdrawn for safety reasons and yet Dr Salisbury in his statement to the GMC sums up by saying this is a vaccine with an exemplary safety record. Well, if that is his idea of an excellent safety record then we have a very different perception he and I of vaccine safety. And so we come full circle now because it turns out the Dean was right. Ari Zuckerman was right. Based upon the information he got, he says (probably from Dr Salisbury way back when these parents started coming to us in 1996/7), that it was the government that was going to be sued. I thought it was going to be the drug companies, but it wasn't. Why was it the government? Because the government had given the drug companies an indemnity against harm and so this is why we are here, this is what this is all about (1:19), this is what this whole GMC affair and effort to descredit doctors questioning the safety of the MMR vaccine has come about because of an indemnity given to the drug companies all those years ago for the introduction of an unsafe vaccine by perhaps just a few members of the department of Health or recommended by the Dept of Health to the Government such that a vaccine (1:53) was introduced and when you ask now, and people have asked, was there an indemnity? is there an indemnity? the answer is catagorically, from Salisbury, time and time again, there was no indemnity (2:07), no letter of comfort, nothing at all....and yet in the minutes of the JCVI, as late on in this story as 1997, there is an entry there that says (it talks about the various brands of vaccine that are available) SKB continued to sell the Urabe strain without liablity (2:39), there it is, in black and white in their own document. I have been every which way around that statement and cannot reconcile it to anything else other than that there was and remains an indemnity, so I am afraid (3:00) that this is really the origins of this whole process and the hope that my colleagues and I be discredited before this information ever becomes public, and in an effort to protect that original decision, that original flawed decision and the consequences that have flowed from it, then we find ourselves in this position, and that is fine but it is not going to stop the truth coming out, and you would think under those circumstances having withdrawn this vaccine (3:37) in Australia, Canada and Japan, and the UK that that would be it, they would get rid of it, because it is not safe, but no (3:46) they go on making it, and what do they do with it, they ship it out to the third world, and there was a mass vaccine campaign in Brazil in the 90's where they gave the great majority of Brazilian children a re-vaccination with MMR, during a very short space of time, with the Urabe containing vaccine, which they knew to be dangerous, which produced an epidemic of meningitis (4:16), a huge peak in the numbers of cases, and there was a paper written about it after, and one of the points in the discussion in the paper was perhaps it was not a good idea, in effect, to do mass vaccination campaigns because it produced the true incidence of side effects to a vaccine. Well, who wrote that, who in God's name wrote that? So this is, if you like, the morality of the people we are dealing with. Why is that vax even on the shelf? Why is it being sold at cut rate price to third world countries? What is the thinking behind this? Because it is certainly not a moral imperative, it must be a commercial one. So that's why we are here and that is why we will remain here, and continue to fight this (5:12) kind of thing, because you can't treat people as expendable. You can't damage them and put them to one side. Adolph Hitler in Mein Kampf once wrote the greater truth excludes the lesser truth. In the world or mind of people like Adolph Hitler and that kind of thinking failed in the 1940s and it is going to fail now. You cannot treat people in a civilised society as expendable. Yes, there may be an argument for a vaccine programme that protects the greater good but that does not mean that you can render those who are damaged, just consign them to the dustcart because they are an inconvenience, or their (6:08) mere presence undermines public confidence, better to keep them hidden out the way and there are too many of these children now, they won't be hidden away, and parents are getting very very angry, and they have every right to be angry, and the truth is going to come out, and it is going to be a very very painful truth when it does come out. The tragedy is, it is going to damage public confidence in vaccine policy across the board because people are going to say we don't believe you any more, we don't trust you, you lied to us and when that happens all vaccination policy is compromised, the whole pillar of public health comes tumbling down and a lot of trouble is going to ensue as you are going to deal with a population who are not protected from these infections and we are going to run into big problems, and that responsibility for that lays at the door of the public health figures and their commercial partners who have allowed this to happen. Question 2: Conflicts of Interest and Dishonesty? There have been some slightly difficult moments about differences of opinion, for example with Horton over conflicts of interests...the Lancet statement on conflict is: 'anything that would embarrass you if it were later disclosed', and my involvement with the Legal Aid Board didn't embarrass me at all, and it wasn't relevant, in my opinion, to disclose it in the Lancet paper because they didn't fund any of the Lancet paper, they funded a subsequent virological study, as was always intended, but it had been misrepresented in the media that they had funded the Lancet study, and it wasn't disclosed, and this was the perception Horton originally had, and when I was asked about this by him way back in 2004 I said, no, they didn't fund the study at all, they funded a separate study, and he said 'well in that case it could be perceived as a potential conflict of interest', and I said where did that come from? The statement as I read it in the Lancet, the requirement is to 'disclose things that might embarrass you if they emerge later'. And it was interesting because within that document, which was self contained, anyone writing a paper for the Lancet would just need to read that and the actual statement is the test of conflict of interest in the Lancet is an easy one, 'anything that would embarrass you', and so you don't go beyond that, it is a self contained document, why would you go any further, but there is a website flagged up in there where you can go and there is a more broader description of conflict of interest there which does include potential or perceived conflicts of interest, which no one ever went to. Why would you do it? You have got it in front of you. Now there is a very big difference. Anything that would embarrass you is the active move, OK, it is what would embarrass me, so I can think what would embarrass me, and I can make a decision about that. What others might perceive to be a conflict of interest is myriad, it goes on forever. You have to put yourself in the third person and think what might someone else with their various views and biases construe to be a conflict of interest, and that is massive, where does that end? So that is a huge conceptual leap in terms as to what you would disclose, and there was no formal way for doing it at the time. Now you have a document where you fill in the boxes, saying no shares, no this, no that. That is very straight foreword, but in those days it wasn't, it was highly ambiguous, and it was always my intention, and always was disclosed, when there was a direct funding for a study, a grant giving body, or in this case the Legal Aid Board, and so in the viral study it was disclosed, 'this study was supported in part by the Legal Aid Board, and Dr Wakefield is acting as an expert in the MMR litigation', that is an easy one as it goes, but in the Lancet study I felt no need to disclose it at all, and neither did any of my colleagues who knew that I was involved with the Legal aid Board on behalf of some of these children. So that was a difficult moment but it was a difference of opinion, he thought I should have disclosed it. I felt at the time that I didn't, now in retrospect, having seen this new document about perceived conflict I can see that it should have been disclosed, but there was no dishonesty, and he was good enough to say there was no intent to deceive, 'when Dr Wakefield was asked about it he was entirely open, he said yes there was this grant'. We got into an argument and debate about what was or wasn't a conflict of interest, but there was absolutely no intent to deceive and the charge is dishonesty, so he was extremely helpful in this as much he said, no this was not dishonest, this was a genuine difference of opinion, and so that then largely resolved. Question 3: Dr Salisbury calls the the GMC ! Where does it leave the GMC if you are not guilty? Very good question on a very broad front. They have some tough decisions to make. One on the level of the case itself, and have they mis-instructed their experts, are they going to have to retrench in a different set of charges. They have to take time to structure those charges and get a response from their experts. Are they going to be allowed to do that, I don't know, but it must be becoming obvious to them now that much of the original information they were given, was, had been, misconstrued, and basing their charges on that information has been in error. At another level they are under big pressure from the Department of Health, and Salisbury in particular has been calling them on a regular basis urging them to prosecute this case more vigorously against me, be nastier, be meaner, throw more in, and I know this because we get sent the unused material, and so I took the opportunity (he didn't know this, I mean you get all the telephone conversations, all the conversation between people, all the draft reports which is an interesting advantage to us), so I was able to write to Salisbury and was able to say I am now in a position to have read the unused material from the GMC, and I note your entreaties to them....He was furious, he contacted the GMC and said: " I didn't know they were going to get the unused material...you never told me, this is a disgrace! " And the wonderful thing about that is that we get the documentation of that telephone conversation as well (laughs). So, you can see they are under a great deal of political pressure to prosecute this case and it is interesting in the public domain Salisbury has said we don't want this to be seen as a vendetta on behalf of the Department of Health. So, mixed messages. PART TWO. The other dilemma they have is who do they represent in the end? Because the GMC have historically stood for the patient, the patients rights, the patients protection from, for example, medical malpractice. Well, who do they stand for now because we stand for the patients. Everything we have done is in the best interests of the children. What they are representing and prosecuting is not on behalf of the children no parent has complained against us, but on behalf of the Department of Health, on behalf of the new kid on the block, 'the greater good.' So here we have a body who has traditionally represented the patient, the victim, if you like, against the medical profession or against medical malpractice. Now they are defending the diktat of public health against the rights of the individual. So they are in a real quandary, or if they are not they should be, about quite who they represent, because I know who I represent--the individual patient. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 6, 2011 Report Share Posted January 6, 2011 full thing http://whale.to/vaccine/wakefield23.html Video transcripts: Dr Wakefield - In His own words 2010 April Question 1: Part 1 Why have you been called to the GMC ? Part 2 Access to Justice Part 3 Professor Zuckerman Forgets Part 4 Dr Armstrong and the BMA Part 5: The Whistle-blower Part 6 Government liability Question 2: Conflicts of Interest and Dishonesty? Question 3: Dr Salisbury calls the the GMC ! Question 1: Part 1 Why have you been called to the GMC ? Why is this hearing being held at all in front of the regulatory body of the UK, and who bought the case and what is the case? The case, it seems, on the face of it, was brought by a single complaint by a freelance journalist who had been working for the Sunday Times, and others, and had been trying to uncover some misdemeanour on our behalf at the Royal free in the investigation of children with regressive autism, with bowel problems, many of the parents of whom said their children regressed after the Measles, Mumps, Rubella vaccine. And I will just take you back, because when I began this work in 1995 parents approached me and said-- my child developed perfectly normally, they had their MMR vaccine, I wasn't anti-vaccine, I took them along, they had their vaccine according to the routine schedule and then the lights went out, eyes glazed over, they lost speech, they lost interaction, they stopped playing with their siblings, they never smiled, they were grizzly, and eventually having lost skills and become mute and self injurious, they were diagnosed with autism or atypical autism. And I said, I am terribly sorry, I know nothing about autism, how can I possibly help, and they said, well, my child has terrible bowel problems, diarrhoea, pain, I know they are in pain, they can't tell me they are in pain because they have lost the ability to speak, but I know they are in pain, my instinct as a mother tells me my child is in pain, they are screaming, they are drawing their knees up to their chest, particularly bad when they have their bowel opened. Losing weight, failing to thrive, and the doctor says your child is autistic, that is just the way it is. Well, that is not just the way it is, that is not what autism is, these are children who are sick, who are clearly unwell. So we put the autism to one side and we said how do we manage these children if they had these symptoms and they were developmentally normal and we would investigate? And so we decided we would, over the course of many months, we put together a protocol, a clinical protocol, for the investigation of these children. What investigations do these children need in order for us to unearth the origins of their problem, for example, do we do a colonoscopy to investigate their bowel problems, are the bowel problems linked to the behaviour? Because the parents were reporting us--when my child's bowel is bad, when they are in pain, their behaviour is terrible, they can't concentrate, they are at their worst autistically, and their autistic mannerisms get worse when their intestine is bad and gets better when their intestine improves, and this was intriguing to us as gastroenterologists because we had seen this before in other gastrointestinal diseases. Gastrointestinal inflammable diseases like Celiac disease, or bacterial overgrowth when you lose a lot of your small intestinal, and you are just left with a little bit behind where bowel bacteria overgrowth leads to deterioration in behaviour, what is called encephalopathy, and often even progressing to coma, and the way you treat that is to treat the bowel, get rid of the bugs in the bowel and the behaviour improves. So we had seen it before, this gut-brain link, something in the bowel affecting the brain, and treating the bowel helping the brain, so why was this different? Was this a similar process? Was, for example, some form of intoxication, some bacterial by-product coming from the intestine and injuring the brain, rather like drinking alcohol, you drink alcohol, it gets to the brain, injures the brain, affects the brain, affects behaviour, and so this was no different, it is not difficult, it is not rocket science, very very straightforward. Something going on in the gut primarily, and injures the brain, so this was an entirely reasonable idea to look at. The other thing is these children had regressed in the face of a viral insult, they had been given a live viral vaccine, they had been given viruses which were known to be able to infect the brain and cause inflammation in the brain, for example autism. So it was entirely appropriate that they would undergo a series of investigations, in other words could we find in a laboratory setting evidence of measles virus in the inflamed intestine. Research. So combining as we should do in an academic institute like the Royal Free, clinical investigation with research. And we progressed through the process thereby refining the clinical investigation. This is necessary, that isn't, this is telling us something, this isn't, out that goes, and then refining the process, so we were getting the maximum amount of information from investigating these children for the minimum inconvenience and risk to the child, and that is just good medicine. So during this process I was approached by some lawyers who were acting on behalf of these children, investigating the parental claim that their child had regressed, disappeared, become autistic after a vaccine. And they said to me, would you help us? You have an interest in Crohn's disease and measles virus, measles vaccine. We are now seeing these new children, what do you think, can you help us in this process? And I thought about it long and hard, and I decided that I would, and I later wrote to my colleagues explaining my reason for doing so, and my feeling was this, it was very straightforward. Vaccination is designed for the greater good, to protect the majority and it does so at the expense of a minority, and that minority of children are those that are damaged by the vaccine, and we don't know the size of the number because it has never been investigated properly, but nonetheless, even if you accept that is a permissible ethical approach, that we can protect the majority at the expense of the minority, then that minority are a group of children who have paid the price for protecting the rest of society, and therefore society has an absolute moral and ethical obligation to care for those children for the rest of their lives, period. That is it, there is no escaping that moral imperative, and yet to acknowledge those children in a public health setting is to raise doubts about the safety of vaccines and therefore it is much better to put them in a corner and forget about them, to pretend they simply don't exist. That is what had happened to these children. The studies that had been designed to look at safety had been designed in such a way as they would never capture these children, nor did anyone want to capture them, nor was anyone interested in the parents story when they said my child has regressed after a vaccine. They were just put in a corner, told it couldn't happen and never investigated, and that was absolutely unacceptable. Part 2 Access to Justice So, the other thing that happened, around the same time, is a parent called me, she is the mother of two autistic children from the Midlands, and she was an older parent, and she had a husband who was older than she was. He was infirm and she herself had arthritis. And she called me one day and she said, doctor Wakefield please don't be judgmental, don't judge me harshly she said, but when I die, I am taking my children with me, and I thought long and hard about that, and I wasn't in any way judgmental, in fact quite the opposite, I was struck. She said to me, Dr Wakefield, no one else cares about my children, I am the only person who loves them and when I die or become infirm to the extent that I can no longer care for them, they are going to be lost, they are going to be on the street and they are going to die on the street because the world doesn't care. And she was right, she was absolutely right, there was nothing for these children, and you will know that in the Thatcher era all the long stay institutions, the old asylums were closed down and turned into luxury apartments and there is nothing left. It is care in the community, what does that mean? It just means shoving people with long term mental disabilities out into the community where they can injure themselves or injure other people, or whatever. Who knows, who follows them, who cares? And that was the future for these children, so, I decided at that point that I would help the lawyers, because if nothing else I was in a position to look at this scientifically, objectively and provide an answer that would, or would not take this story forward, but would nonetheless give these children access to the due process of justice, and that is what they had been denied. So it was about access to justice and surely that cannot be denied anyone, you would think, in a civilised society. So the lawyers asked me what we should do, how would you go about in a scientific context, taking this to the next step, determining whether this temporal association that the mother has made between a child's exposure to this vaccine and regression, how would you then further link that if possible to the virus, and I said the bowel disease that we have seen in these children and the Crohn's disease looks like an infectious disease and you would look for evidence of the virus in sites of infection or obvious swelling of the lymph glands, there is one site in the intestine, it is like swelling of the tonsils when you get a sore throat, you would look in the tonsil for the organism that was causing it. So if you have got swelling of the lymph glands in the intestine, look in there for the evidence of the virus, and measles virus, and measles was a virus that was known to cause this kind of swelling of the intestinal lymph glands. So it made logical sense to look in those areas and so we set up a study. I was asked to design a study that would take this to that level, that we would get funding from the Legal Aid Board (LAB), hypothetically, and then we would look for evidence of the virus in the intestine, and after a series of exchanges, and a protocol was prepared, we received acknowledgement of funding form the LAB to conduct that study. It is was negative it was negative, if it was positive it was positive, either way it got published. It was not designed to produce a particular answer, it was just designed to produce an answer, is the virus there, or not? It didn't make it causation but it was a piece, a crucial piece of the jigsaw that took it to the next level. Part 3 Professor Zuckerman Forgets [ Zuckerman] Interestingly, the Dean of the medical school, Prof Ari Zuckerman, world renowned virologist, expert in Hepatitis B, worked very closely with the WHO, was deeply involved with hepatitis B vaccination, a great advocate of hepatitis B vaccination, different story, but nonetheless, there he was in the general apparatchik of the vaccine advocates. And he said to me that he had been contacted by the Department of Health and a certain members of the Royal College of Child Health who had made him aware of this funding, and I said yes, this is a grant we got from them and perfectly respectable, and we are conducting the science, and he said there was a conflict of interest, a clear conflict of interest, and I couldn't understand it, why? Why was there a conflict of interest? I had no conflict of interest, I was asked to take this grant to conduct a piece of science and give an answer. That wasn't a conflict of interest. The funding would be disclosed in the paper that wrote up the science, the funding came from the Legal Aid Board, but beyond that where was the conflict? Anyway, I wrote back to him and said your suggestion that there is a conflict of interest has exercised my mind greatly over the last several months and I cannot see where it lies, and i laid out for him the context of my discussions with the lawyers and the work that was to be done, and he wrote back to me and couldn't precisely define what the conflict was, but talked about if a legal action was anticipated, and preliminary discussions had already taken place then there was a conflict, and it didn't really make a lot of sense to me. I wrote back to him again and reiterated that we had been asked to do a piece of science that wasn't seeking a particular answer. I wouldn't have got involved in the first place if there was any effort of coercion or demanding that......we own the data, the lawyers didn't own it. We would do what we felt was scientifically appropriate, and I had every faith in the lawyers, they seemed very concerned, genuinely concerned about these children, they weren't in any way ambulance chasers but nonetheless there was some clear problem for the Dean in this, and he ultimately refused to take the money, and I said send it back, we don't want it, if you are not going to let us do this, we won't do it. Anyway, one of my colleagues said we will put it into an account at the hospital, a charitable account...and see if that is OK. So we did, now, interestingly the Dean has just appeared as a witness on behalf of the prosecution at the GMC. Professor Ari Zuckerman, now 7 years retired and clearly deeply frustrated that he should be dragged out of retirement to have to give his evidence in this case, but nonetheless his first foray was to say, yes, when this money was transferred by the accountant of the Royal Free Medical School it was too late, I didn't know about it, it had already happened, I couldn't stop it. It is interesting that he actually signed the cheque for the transfer. Surprising that, given the fact that it had already happened by the time he knew about it, nonetheless an interval of 11 years can cloud ones mind, memory of things. There we are. But that was the first error he made. Part 4 Dr Armstrong and the BMA What he disclosed, interestingly, to me during that period was that he had written to the ethics committee of the British Medial Association (BMA), to take their advice, how to deal with this perplexing issue that was causing him concern about conflicts of interest that has was really unable to articulate to me. So he wrote to Dr Armstrong at the BMA ethics committee to ask their opinion, and in it unbeknown to me at the time, he had said he had been contacted by the Department of Health who said to him that the government stood to be sued by the parents of children affected by MMR or apparently affected by MMR vaccine, and that this to him was a conflict of interest. That government was going to be sued. Do you understand, I came into this with the lawyers believing the case was against the vaccine manufacturers, the government didn't even come into it, but he was clearly under the impression that the government were going to be sued. He also said that this may be embarrassing for the medical school. Now, we were never party to the ultimate response of Dr Armstrong of the BMA. We were never told about it. All we did when he wrote back to me is to say you will know that I have taken advice on this matter from the BMA and leave it that, as though the BMA had ruled completely against it. When in fact we got the documents, as we did do as part of the disclosure for the GMC, there it was, the letter from Dr Armstrong, not only endorsing the fact this study could and should be done because it was morally and ethically proper that it should be done, but that not to do it because it was embarrassing to an institute or because it meant the government might be sued was not a sound moral argument. His words. So in other words the BMA ethics committee said this is fine. It said actions of this kind or research of this kind is often funded by a group with a particular interest. Of course they are, the Multiple Sclerosis Society funds research for MS in the hope that it can make patients better. So here we have another group of people with a vested interest funding a piece of research. As long as it is ethical, and as long as it is conducted in a way that it is published, whether it is positive or negative, then that is fine. Nonetheless Prof Zuckerman did not get the answer he wanted. He never disclosed that to us, he just kept beating us over the head with the certain knowledge that he had contacted the BMA and they had given him an opinion. Part 5: The Whistle-blower ....................Dr Alistair who was from the ish dept of health, and Dr had been seconded onto the JCVI, effectively from Canada, and he had been brought in, at least in part, to advise on the introduction of MMR vaccine. The experience in Canada was that they introduced a vaccine which contained a mumps component made up of a strain of the vaccine called Urabe, which was originally generated in Japan and they had run into problems with this vaccine. It produced meningitis in children (1:43). the mumps virus was identified in the brain of the children and the vaccine was pulled in Canada, it was pulled, it was stopped in 1997 (1:53), nonetheless this was the vaccine that was intended to be introduced into the UK a year later in 1988. They changed the name, but the vaccine was identical, so it had gone from Trivirix to Pluserix in the UK, an identical vaccine that had already been withdrawn for safety reasons, in Canada. Now advised the JCVI not to introduce this vaccine because it was not safe. He was overruled. He said if you are going to introduce it then you should have active surveillance. That is doctors or people going out and asking doctors--have you seen and cases of the following in the past month, not waiting for doctors to spontaneously report. Spontaneous reporting picks up 1-2% of those adverse reactions.....It is totally inadequate but they were totally overruled, not active surveillance (3:02). So they were going to intro a vaccine that has been withdrawn in other countries, known to be unsafe and they were going to have no active surveillance (3:08) for possible adverse events in this country. Now this was done, he said, for competitive pricing reasons. The strain of the vaccine that contained the dangerous mumps component was approx. 1/4 the price of the American MMRII made by Merck. There had been no reports of meningitis using the Merck vaccine which contained a strain of mumps called Jeryl Lynn....So what we had was a cheaper vaccine that was known to be dangerous (3:47), so when the vaccines were licensed or the proposal to licence these vaccines, the JCVI or members of that committee (4:0) went to Kline Beecham (SKB) and said we want your vaccine. SKB said we are not happy about it because this has already been withdrawn in Canada, it has got this mumps component in it which is dodgy They said if we are going to do it then we want an indemnity, we want indemnity from prosecution for damage to children on the basis (4:27) of the receipt of the vaccine, and it appears that indemnity was granted, and told us about this (4:33), and he said at the meeting, the girl there from SKB said we are immunising the children and the government is immunising us. So the vaccine was produced, licensed, given, and cases of meningitis started to appear. they were recorded and documented in the minutes of the JCVI which are now available on line and have been obtained by us as part of our investigation. More and more cases began to be reported, the ish dept' withdrew this vax, certain health areas rejected the Urabe containing vaccine but still the JCVI continued with it. There was no withdrawal of this vaccine until finally a study was grudgingly done in Nottingham where they found a much higher risk of meningitis with this vaccine (5:33) than had previously been predicted by passive surveillance, and the vaccine was withdrawn overnight, and it was only withdrawn overnight because it was leaked to the press. It appeared in a newspaper and suddenly the vaccine was pulled. So a dangerous vaccine, a knowingly dangerous vaccine was introduced and ultimately proven to be dangerous and had to be withdrawn (6:00) in 1992. Part 6 Government liability The two of the three vaccine brands that were introduced in 1988 had to be withdrawn for safety reasons and yet Dr Salisbury in his statement to the GMC sums up by saying this is a vaccine with an exemplary safety record. Well, if that is his idea of an excellent safety record then we have a very different perception he and I of vaccine safety. And so we come full circle now because it turns out the Dean was right. Ari Zuckerman was right. Based upon the information he got, he says (probably from Dr Salisbury way back when these parents started coming to us in 1996/7), that it was the government that was going to be sued. I thought it was going to be the drug companies, but it wasn't. Why was it the government? Because the government had given the drug companies an indemnity against harm and so this is why we are here, this is what this is all about (1:19), this is what this whole GMC affair and effort to descredit doctors questioning the safety of the MMR vaccine has come about because of an indemnity given to the drug companies all those years ago for the introduction of an unsafe vaccine by perhaps just a few members of the department of Health or recommended by the Dept of Health to the Government such that a vaccine (1:53) was introduced and when you ask now, and people have asked, was there an indemnity? is there an indemnity? the answer is catagorically, from Salisbury, time and time again, there was no indemnity (2:07), no letter of comfort, nothing at all....and yet in the minutes of the JCVI, as late on in this story as 1997, there is an entry there that says (it talks about the various brands of vaccine that are available) SKB continued to sell the Urabe strain without liablity (2:39), there it is, in black and white in their own document. I have been every which way around that statement and cannot reconcile it to anything else other than that there was and remains an indemnity, so I am afraid (3:00) that this is really the origins of this whole process and the hope that my colleagues and I be discredited before this information ever becomes public, and in an effort to protect that original decision, that original flawed decision and the consequences that have flowed from it, then we find ourselves in this position, and that is fine but it is not going to stop the truth coming out, and you would think under those circumstances having withdrawn this vaccine (3:37) in Australia, Canada and Japan, and the UK that that would be it, they would get rid of it, because it is not safe, but no (3:46) they go on making it, and what do they do with it, they ship it out to the third world, and there was a mass vaccine campaign in Brazil in the 90's where they gave the great majority of Brazilian children a re-vaccination with MMR, during a very short space of time, with the Urabe containing vaccine, which they knew to be dangerous, which produced an epidemic of meningitis (4:16), a huge peak in the numbers of cases, and there was a paper written about it after, and one of the points in the discussion in the paper was perhaps it was not a good idea, in effect, to do mass vaccination campaigns because it produced the true incidence of side effects to a vaccine. Well, who wrote that, who in God's name wrote that? So this is, if you like, the morality of the people we are dealing with. Why is that vax even on the shelf? Why is it being sold at cut rate price to third world countries? What is the thinking behind this? Because it is certainly not a moral imperative, it must be a commercial one. So that's why we are here and that is why we will remain here, and continue to fight this (5:12) kind of thing, because you can't treat people as expendable. You can't damage them and put them to one side. Adolph Hitler in Mein Kampf once wrote the greater truth excludes the lesser truth. In the world or mind of people like Adolph Hitler and that kind of thinking failed in the 1940s and it is going to fail now. You cannot treat people in a civilised society as expendable. Yes, there may be an argument for a vaccine programme that protects the greater good but that does not mean that you can render those who are damaged, just consign them to the dustcart because they are an inconvenience, or their (6:08) mere presence undermines public confidence, better to keep them hidden out the way and there are too many of these children now, they won't be hidden away, and parents are getting very very angry, and they have every right to be angry, and the truth is going to come out, and it is going to be a very very painful truth when it does come out. The tragedy is, it is going to damage public confidence in vaccine policy across the board because people are going to say we don't believe you any more, we don't trust you, you lied to us and when that happens all vaccination policy is compromised, the whole pillar of public health comes tumbling down and a lot of trouble is going to ensue as you are going to deal with a population who are not protected from these infections and we are going to run into big problems, and that responsibility for that lays at the door of the public health figures and their commercial partners who have allowed this to happen. Question 2: Conflicts of Interest and Dishonesty? There have been some slightly difficult moments about differences of opinion, for example with Horton over conflicts of interests...the Lancet statement on conflict is: 'anything that would embarrass you if it were later disclosed', and my involvement with the Legal Aid Board didn't embarrass me at all, and it wasn't relevant, in my opinion, to disclose it in the Lancet paper because they didn't fund any of the Lancet paper, they funded a subsequent virological study, as was always intended, but it had been misrepresented in the media that they had funded the Lancet study, and it wasn't disclosed, and this was the perception Horton originally had, and when I was asked about this by him way back in 2004 I said, no, they didn't fund the study at all, they funded a separate study, and he said 'well in that case it could be perceived as a potential conflict of interest', and I said where did that come from? The statement as I read it in the Lancet, the requirement is to 'disclose things that might embarrass you if they emerge later'. And it was interesting because within that document, which was self contained, anyone writing a paper for the Lancet would just need to read that and the actual statement is the test of conflict of interest in the Lancet is an easy one, 'anything that would embarrass you', and so you don't go beyond that, it is a self contained document, why would you go any further, but there is a website flagged up in there where you can go and there is a more broader description of conflict of interest there which does include potential or perceived conflicts of interest, which no one ever went to. Why would you do it? You have got it in front of you. Now there is a very big difference. Anything that would embarrass you is the active move, OK, it is what would embarrass me, so I can think what would embarrass me, and I can make a decision about that. What others might perceive to be a conflict of interest is myriad, it goes on forever. You have to put yourself in the third person and think what might someone else with their various views and biases construe to be a conflict of interest, and that is massive, where does that end? So that is a huge conceptual leap in terms as to what you would disclose, and there was no formal way for doing it at the time. Now you have a document where you fill in the boxes, saying no shares, no this, no that. That is very straight foreword, but in those days it wasn't, it was highly ambiguous, and it was always my intention, and always was disclosed, when there was a direct funding for a study, a grant giving body, or in this case the Legal Aid Board, and so in the viral study it was disclosed, 'this study was supported in part by the Legal Aid Board, and Dr Wakefield is acting as an expert in the MMR litigation', that is an easy one as it goes, but in the Lancet study I felt no need to disclose it at all, and neither did any of my colleagues who knew that I was involved with the Legal aid Board on behalf of some of these children. So that was a difficult moment but it was a difference of opinion, he thought I should have disclosed it. I felt at the time that I didn't, now in retrospect, having seen this new document about perceived conflict I can see that it should have been disclosed, but there was no dishonesty, and he was good enough to say there was no intent to deceive, 'when Dr Wakefield was asked about it he was entirely open, he said yes there was this grant'. We got into an argument and debate about what was or wasn't a conflict of interest, but there was absolutely no intent to deceive and the charge is dishonesty, so he was extremely helpful in this as much he said, no this was not dishonest, this was a genuine difference of opinion, and so that then largely resolved. Question 3: Dr Salisbury calls the the GMC ! Where does it leave the GMC if you are not guilty? Very good question on a very broad front. They have some tough decisions to make. One on the level of the case itself, and have they mis-instructed their experts, are they going to have to retrench in a different set of charges. They have to take time to structure those charges and get a response from their experts. Are they going to be allowed to do that, I don't know, but it must be becoming obvious to them now that much of the original information they were given, was, had been, misconstrued, and basing their charges on that information has been in error. At another level they are under big pressure from the Department of Health, and Salisbury in particular has been calling them on a regular basis urging them to prosecute this case more vigorously against me, be nastier, be meaner, throw more in, and I know this because we get sent the unused material, and so I took the opportunity (he didn't know this, I mean you get all the telephone conversations, all the conversation between people, all the draft reports which is an interesting advantage to us), so I was able to write to Salisbury and was able to say I am now in a position to have read the unused material from the GMC, and I note your entreaties to them....He was furious, he contacted the GMC and said: " I didn't know they were going to get the unused material...you never told me, this is a disgrace! " And the wonderful thing about that is that we get the documentation of that telephone conversation as well (laughs). So, you can see they are under a great deal of political pressure to prosecute this case and it is interesting in the public domain Salisbury has said we don't want this to be seen as a vendetta on behalf of the Department of Health. So, mixed messages. PART TWO. The other dilemma they have is who do they represent in the end? Because the GMC have historically stood for the patient, the patients rights, the patients protection from, for example, medical malpractice. Well, who do they stand for now because we stand for the patients. Everything we have done is in the best interests of the children. What they are representing and prosecuting is not on behalf of the children no parent has complained against us, but on behalf of the Department of Health, on behalf of the new kid on the block, 'the greater good.' So here we have a body who has traditionally represented the patient, the victim, if you like, against the medical profession or against medical malpractice. Now they are defending the diktat of public health against the rights of the individual. So they are in a real quandary, or if they are not they should be, about quite who they represent, because I know who I represent--the individual patient. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 6, 2011 Report Share Posted January 6, 2011 full thing http://whale.to/vaccine/wakefield23.html Video transcripts: Dr Wakefield - In His own words 2010 April Question 1: Part 1 Why have you been called to the GMC ? Part 2 Access to Justice Part 3 Professor Zuckerman Forgets Part 4 Dr Armstrong and the BMA Part 5: The Whistle-blower Part 6 Government liability Question 2: Conflicts of Interest and Dishonesty? Question 3: Dr Salisbury calls the the GMC ! Question 1: Part 1 Why have you been called to the GMC ? Why is this hearing being held at all in front of the regulatory body of the UK, and who bought the case and what is the case? The case, it seems, on the face of it, was brought by a single complaint by a freelance journalist who had been working for the Sunday Times, and others, and had been trying to uncover some misdemeanour on our behalf at the Royal free in the investigation of children with regressive autism, with bowel problems, many of the parents of whom said their children regressed after the Measles, Mumps, Rubella vaccine. And I will just take you back, because when I began this work in 1995 parents approached me and said-- my child developed perfectly normally, they had their MMR vaccine, I wasn't anti-vaccine, I took them along, they had their vaccine according to the routine schedule and then the lights went out, eyes glazed over, they lost speech, they lost interaction, they stopped playing with their siblings, they never smiled, they were grizzly, and eventually having lost skills and become mute and self injurious, they were diagnosed with autism or atypical autism. And I said, I am terribly sorry, I know nothing about autism, how can I possibly help, and they said, well, my child has terrible bowel problems, diarrhoea, pain, I know they are in pain, they can't tell me they are in pain because they have lost the ability to speak, but I know they are in pain, my instinct as a mother tells me my child is in pain, they are screaming, they are drawing their knees up to their chest, particularly bad when they have their bowel opened. Losing weight, failing to thrive, and the doctor says your child is autistic, that is just the way it is. Well, that is not just the way it is, that is not what autism is, these are children who are sick, who are clearly unwell. So we put the autism to one side and we said how do we manage these children if they had these symptoms and they were developmentally normal and we would investigate? And so we decided we would, over the course of many months, we put together a protocol, a clinical protocol, for the investigation of these children. What investigations do these children need in order for us to unearth the origins of their problem, for example, do we do a colonoscopy to investigate their bowel problems, are the bowel problems linked to the behaviour? Because the parents were reporting us--when my child's bowel is bad, when they are in pain, their behaviour is terrible, they can't concentrate, they are at their worst autistically, and their autistic mannerisms get worse when their intestine is bad and gets better when their intestine improves, and this was intriguing to us as gastroenterologists because we had seen this before in other gastrointestinal diseases. Gastrointestinal inflammable diseases like Celiac disease, or bacterial overgrowth when you lose a lot of your small intestinal, and you are just left with a little bit behind where bowel bacteria overgrowth leads to deterioration in behaviour, what is called encephalopathy, and often even progressing to coma, and the way you treat that is to treat the bowel, get rid of the bugs in the bowel and the behaviour improves. So we had seen it before, this gut-brain link, something in the bowel affecting the brain, and treating the bowel helping the brain, so why was this different? Was this a similar process? Was, for example, some form of intoxication, some bacterial by-product coming from the intestine and injuring the brain, rather like drinking alcohol, you drink alcohol, it gets to the brain, injures the brain, affects the brain, affects behaviour, and so this was no different, it is not difficult, it is not rocket science, very very straightforward. Something going on in the gut primarily, and injures the brain, so this was an entirely reasonable idea to look at. The other thing is these children had regressed in the face of a viral insult, they had been given a live viral vaccine, they had been given viruses which were known to be able to infect the brain and cause inflammation in the brain, for example autism. So it was entirely appropriate that they would undergo a series of investigations, in other words could we find in a laboratory setting evidence of measles virus in the inflamed intestine. Research. So combining as we should do in an academic institute like the Royal Free, clinical investigation with research. And we progressed through the process thereby refining the clinical investigation. This is necessary, that isn't, this is telling us something, this isn't, out that goes, and then refining the process, so we were getting the maximum amount of information from investigating these children for the minimum inconvenience and risk to the child, and that is just good medicine. So during this process I was approached by some lawyers who were acting on behalf of these children, investigating the parental claim that their child had regressed, disappeared, become autistic after a vaccine. And they said to me, would you help us? You have an interest in Crohn's disease and measles virus, measles vaccine. We are now seeing these new children, what do you think, can you help us in this process? And I thought about it long and hard, and I decided that I would, and I later wrote to my colleagues explaining my reason for doing so, and my feeling was this, it was very straightforward. Vaccination is designed for the greater good, to protect the majority and it does so at the expense of a minority, and that minority of children are those that are damaged by the vaccine, and we don't know the size of the number because it has never been investigated properly, but nonetheless, even if you accept that is a permissible ethical approach, that we can protect the majority at the expense of the minority, then that minority are a group of children who have paid the price for protecting the rest of society, and therefore society has an absolute moral and ethical obligation to care for those children for the rest of their lives, period. That is it, there is no escaping that moral imperative, and yet to acknowledge those children in a public health setting is to raise doubts about the safety of vaccines and therefore it is much better to put them in a corner and forget about them, to pretend they simply don't exist. That is what had happened to these children. The studies that had been designed to look at safety had been designed in such a way as they would never capture these children, nor did anyone want to capture them, nor was anyone interested in the parents story when they said my child has regressed after a vaccine. They were just put in a corner, told it couldn't happen and never investigated, and that was absolutely unacceptable. Part 2 Access to Justice So, the other thing that happened, around the same time, is a parent called me, she is the mother of two autistic children from the Midlands, and she was an older parent, and she had a husband who was older than she was. He was infirm and she herself had arthritis. And she called me one day and she said, doctor Wakefield please don't be judgmental, don't judge me harshly she said, but when I die, I am taking my children with me, and I thought long and hard about that, and I wasn't in any way judgmental, in fact quite the opposite, I was struck. She said to me, Dr Wakefield, no one else cares about my children, I am the only person who loves them and when I die or become infirm to the extent that I can no longer care for them, they are going to be lost, they are going to be on the street and they are going to die on the street because the world doesn't care. And she was right, she was absolutely right, there was nothing for these children, and you will know that in the Thatcher era all the long stay institutions, the old asylums were closed down and turned into luxury apartments and there is nothing left. It is care in the community, what does that mean? It just means shoving people with long term mental disabilities out into the community where they can injure themselves or injure other people, or whatever. Who knows, who follows them, who cares? And that was the future for these children, so, I decided at that point that I would help the lawyers, because if nothing else I was in a position to look at this scientifically, objectively and provide an answer that would, or would not take this story forward, but would nonetheless give these children access to the due process of justice, and that is what they had been denied. So it was about access to justice and surely that cannot be denied anyone, you would think, in a civilised society. So the lawyers asked me what we should do, how would you go about in a scientific context, taking this to the next step, determining whether this temporal association that the mother has made between a child's exposure to this vaccine and regression, how would you then further link that if possible to the virus, and I said the bowel disease that we have seen in these children and the Crohn's disease looks like an infectious disease and you would look for evidence of the virus in sites of infection or obvious swelling of the lymph glands, there is one site in the intestine, it is like swelling of the tonsils when you get a sore throat, you would look in the tonsil for the organism that was causing it. So if you have got swelling of the lymph glands in the intestine, look in there for the evidence of the virus, and measles virus, and measles was a virus that was known to cause this kind of swelling of the intestinal lymph glands. So it made logical sense to look in those areas and so we set up a study. I was asked to design a study that would take this to that level, that we would get funding from the Legal Aid Board (LAB), hypothetically, and then we would look for evidence of the virus in the intestine, and after a series of exchanges, and a protocol was prepared, we received acknowledgement of funding form the LAB to conduct that study. It is was negative it was negative, if it was positive it was positive, either way it got published. It was not designed to produce a particular answer, it was just designed to produce an answer, is the virus there, or not? It didn't make it causation but it was a piece, a crucial piece of the jigsaw that took it to the next level. Part 3 Professor Zuckerman Forgets [ Zuckerman] Interestingly, the Dean of the medical school, Prof Ari Zuckerman, world renowned virologist, expert in Hepatitis B, worked very closely with the WHO, was deeply involved with hepatitis B vaccination, a great advocate of hepatitis B vaccination, different story, but nonetheless, there he was in the general apparatchik of the vaccine advocates. And he said to me that he had been contacted by the Department of Health and a certain members of the Royal College of Child Health who had made him aware of this funding, and I said yes, this is a grant we got from them and perfectly respectable, and we are conducting the science, and he said there was a conflict of interest, a clear conflict of interest, and I couldn't understand it, why? Why was there a conflict of interest? I had no conflict of interest, I was asked to take this grant to conduct a piece of science and give an answer. That wasn't a conflict of interest. The funding would be disclosed in the paper that wrote up the science, the funding came from the Legal Aid Board, but beyond that where was the conflict? Anyway, I wrote back to him and said your suggestion that there is a conflict of interest has exercised my mind greatly over the last several months and I cannot see where it lies, and i laid out for him the context of my discussions with the lawyers and the work that was to be done, and he wrote back to me and couldn't precisely define what the conflict was, but talked about if a legal action was anticipated, and preliminary discussions had already taken place then there was a conflict, and it didn't really make a lot of sense to me. I wrote back to him again and reiterated that we had been asked to do a piece of science that wasn't seeking a particular answer. I wouldn't have got involved in the first place if there was any effort of coercion or demanding that......we own the data, the lawyers didn't own it. We would do what we felt was scientifically appropriate, and I had every faith in the lawyers, they seemed very concerned, genuinely concerned about these children, they weren't in any way ambulance chasers but nonetheless there was some clear problem for the Dean in this, and he ultimately refused to take the money, and I said send it back, we don't want it, if you are not going to let us do this, we won't do it. Anyway, one of my colleagues said we will put it into an account at the hospital, a charitable account...and see if that is OK. So we did, now, interestingly the Dean has just appeared as a witness on behalf of the prosecution at the GMC. Professor Ari Zuckerman, now 7 years retired and clearly deeply frustrated that he should be dragged out of retirement to have to give his evidence in this case, but nonetheless his first foray was to say, yes, when this money was transferred by the accountant of the Royal Free Medical School it was too late, I didn't know about it, it had already happened, I couldn't stop it. It is interesting that he actually signed the cheque for the transfer. Surprising that, given the fact that it had already happened by the time he knew about it, nonetheless an interval of 11 years can cloud ones mind, memory of things. There we are. But that was the first error he made. Part 4 Dr Armstrong and the BMA What he disclosed, interestingly, to me during that period was that he had written to the ethics committee of the British Medial Association (BMA), to take their advice, how to deal with this perplexing issue that was causing him concern about conflicts of interest that has was really unable to articulate to me. So he wrote to Dr Armstrong at the BMA ethics committee to ask their opinion, and in it unbeknown to me at the time, he had said he had been contacted by the Department of Health who said to him that the government stood to be sued by the parents of children affected by MMR or apparently affected by MMR vaccine, and that this to him was a conflict of interest. That government was going to be sued. Do you understand, I came into this with the lawyers believing the case was against the vaccine manufacturers, the government didn't even come into it, but he was clearly under the impression that the government were going to be sued. He also said that this may be embarrassing for the medical school. Now, we were never party to the ultimate response of Dr Armstrong of the BMA. We were never told about it. All we did when he wrote back to me is to say you will know that I have taken advice on this matter from the BMA and leave it that, as though the BMA had ruled completely against it. When in fact we got the documents, as we did do as part of the disclosure for the GMC, there it was, the letter from Dr Armstrong, not only endorsing the fact this study could and should be done because it was morally and ethically proper that it should be done, but that not to do it because it was embarrassing to an institute or because it meant the government might be sued was not a sound moral argument. His words. So in other words the BMA ethics committee said this is fine. It said actions of this kind or research of this kind is often funded by a group with a particular interest. Of course they are, the Multiple Sclerosis Society funds research for MS in the hope that it can make patients better. So here we have another group of people with a vested interest funding a piece of research. As long as it is ethical, and as long as it is conducted in a way that it is published, whether it is positive or negative, then that is fine. Nonetheless Prof Zuckerman did not get the answer he wanted. He never disclosed that to us, he just kept beating us over the head with the certain knowledge that he had contacted the BMA and they had given him an opinion. Part 5: The Whistle-blower ....................Dr Alistair who was from the ish dept of health, and Dr had been seconded onto the JCVI, effectively from Canada, and he had been brought in, at least in part, to advise on the introduction of MMR vaccine. The experience in Canada was that they introduced a vaccine which contained a mumps component made up of a strain of the vaccine called Urabe, which was originally generated in Japan and they had run into problems with this vaccine. It produced meningitis in children (1:43). the mumps virus was identified in the brain of the children and the vaccine was pulled in Canada, it was pulled, it was stopped in 1997 (1:53), nonetheless this was the vaccine that was intended to be introduced into the UK a year later in 1988. They changed the name, but the vaccine was identical, so it had gone from Trivirix to Pluserix in the UK, an identical vaccine that had already been withdrawn for safety reasons, in Canada. Now advised the JCVI not to introduce this vaccine because it was not safe. He was overruled. He said if you are going to introduce it then you should have active surveillance. That is doctors or people going out and asking doctors--have you seen and cases of the following in the past month, not waiting for doctors to spontaneously report. Spontaneous reporting picks up 1-2% of those adverse reactions.....It is totally inadequate but they were totally overruled, not active surveillance (3:02). So they were going to intro a vaccine that has been withdrawn in other countries, known to be unsafe and they were going to have no active surveillance (3:08) for possible adverse events in this country. Now this was done, he said, for competitive pricing reasons. The strain of the vaccine that contained the dangerous mumps component was approx. 1/4 the price of the American MMRII made by Merck. There had been no reports of meningitis using the Merck vaccine which contained a strain of mumps called Jeryl Lynn....So what we had was a cheaper vaccine that was known to be dangerous (3:47), so when the vaccines were licensed or the proposal to licence these vaccines, the JCVI or members of that committee (4:0) went to Kline Beecham (SKB) and said we want your vaccine. SKB said we are not happy about it because this has already been withdrawn in Canada, it has got this mumps component in it which is dodgy They said if we are going to do it then we want an indemnity, we want indemnity from prosecution for damage to children on the basis (4:27) of the receipt of the vaccine, and it appears that indemnity was granted, and told us about this (4:33), and he said at the meeting, the girl there from SKB said we are immunising the children and the government is immunising us. So the vaccine was produced, licensed, given, and cases of meningitis started to appear. they were recorded and documented in the minutes of the JCVI which are now available on line and have been obtained by us as part of our investigation. More and more cases began to be reported, the ish dept' withdrew this vax, certain health areas rejected the Urabe containing vaccine but still the JCVI continued with it. There was no withdrawal of this vaccine until finally a study was grudgingly done in Nottingham where they found a much higher risk of meningitis with this vaccine (5:33) than had previously been predicted by passive surveillance, and the vaccine was withdrawn overnight, and it was only withdrawn overnight because it was leaked to the press. It appeared in a newspaper and suddenly the vaccine was pulled. So a dangerous vaccine, a knowingly dangerous vaccine was introduced and ultimately proven to be dangerous and had to be withdrawn (6:00) in 1992. Part 6 Government liability The two of the three vaccine brands that were introduced in 1988 had to be withdrawn for safety reasons and yet Dr Salisbury in his statement to the GMC sums up by saying this is a vaccine with an exemplary safety record. Well, if that is his idea of an excellent safety record then we have a very different perception he and I of vaccine safety. And so we come full circle now because it turns out the Dean was right. Ari Zuckerman was right. Based upon the information he got, he says (probably from Dr Salisbury way back when these parents started coming to us in 1996/7), that it was the government that was going to be sued. I thought it was going to be the drug companies, but it wasn't. Why was it the government? Because the government had given the drug companies an indemnity against harm and so this is why we are here, this is what this is all about (1:19), this is what this whole GMC affair and effort to descredit doctors questioning the safety of the MMR vaccine has come about because of an indemnity given to the drug companies all those years ago for the introduction of an unsafe vaccine by perhaps just a few members of the department of Health or recommended by the Dept of Health to the Government such that a vaccine (1:53) was introduced and when you ask now, and people have asked, was there an indemnity? is there an indemnity? the answer is catagorically, from Salisbury, time and time again, there was no indemnity (2:07), no letter of comfort, nothing at all....and yet in the minutes of the JCVI, as late on in this story as 1997, there is an entry there that says (it talks about the various brands of vaccine that are available) SKB continued to sell the Urabe strain without liablity (2:39), there it is, in black and white in their own document. I have been every which way around that statement and cannot reconcile it to anything else other than that there was and remains an indemnity, so I am afraid (3:00) that this is really the origins of this whole process and the hope that my colleagues and I be discredited before this information ever becomes public, and in an effort to protect that original decision, that original flawed decision and the consequences that have flowed from it, then we find ourselves in this position, and that is fine but it is not going to stop the truth coming out, and you would think under those circumstances having withdrawn this vaccine (3:37) in Australia, Canada and Japan, and the UK that that would be it, they would get rid of it, because it is not safe, but no (3:46) they go on making it, and what do they do with it, they ship it out to the third world, and there was a mass vaccine campaign in Brazil in the 90's where they gave the great majority of Brazilian children a re-vaccination with MMR, during a very short space of time, with the Urabe containing vaccine, which they knew to be dangerous, which produced an epidemic of meningitis (4:16), a huge peak in the numbers of cases, and there was a paper written about it after, and one of the points in the discussion in the paper was perhaps it was not a good idea, in effect, to do mass vaccination campaigns because it produced the true incidence of side effects to a vaccine. Well, who wrote that, who in God's name wrote that? So this is, if you like, the morality of the people we are dealing with. Why is that vax even on the shelf? Why is it being sold at cut rate price to third world countries? What is the thinking behind this? Because it is certainly not a moral imperative, it must be a commercial one. So that's why we are here and that is why we will remain here, and continue to fight this (5:12) kind of thing, because you can't treat people as expendable. You can't damage them and put them to one side. Adolph Hitler in Mein Kampf once wrote the greater truth excludes the lesser truth. In the world or mind of people like Adolph Hitler and that kind of thinking failed in the 1940s and it is going to fail now. You cannot treat people in a civilised society as expendable. Yes, there may be an argument for a vaccine programme that protects the greater good but that does not mean that you can render those who are damaged, just consign them to the dustcart because they are an inconvenience, or their (6:08) mere presence undermines public confidence, better to keep them hidden out the way and there are too many of these children now, they won't be hidden away, and parents are getting very very angry, and they have every right to be angry, and the truth is going to come out, and it is going to be a very very painful truth when it does come out. The tragedy is, it is going to damage public confidence in vaccine policy across the board because people are going to say we don't believe you any more, we don't trust you, you lied to us and when that happens all vaccination policy is compromised, the whole pillar of public health comes tumbling down and a lot of trouble is going to ensue as you are going to deal with a population who are not protected from these infections and we are going to run into big problems, and that responsibility for that lays at the door of the public health figures and their commercial partners who have allowed this to happen. Question 2: Conflicts of Interest and Dishonesty? There have been some slightly difficult moments about differences of opinion, for example with Horton over conflicts of interests...the Lancet statement on conflict is: 'anything that would embarrass you if it were later disclosed', and my involvement with the Legal Aid Board didn't embarrass me at all, and it wasn't relevant, in my opinion, to disclose it in the Lancet paper because they didn't fund any of the Lancet paper, they funded a subsequent virological study, as was always intended, but it had been misrepresented in the media that they had funded the Lancet study, and it wasn't disclosed, and this was the perception Horton originally had, and when I was asked about this by him way back in 2004 I said, no, they didn't fund the study at all, they funded a separate study, and he said 'well in that case it could be perceived as a potential conflict of interest', and I said where did that come from? The statement as I read it in the Lancet, the requirement is to 'disclose things that might embarrass you if they emerge later'. And it was interesting because within that document, which was self contained, anyone writing a paper for the Lancet would just need to read that and the actual statement is the test of conflict of interest in the Lancet is an easy one, 'anything that would embarrass you', and so you don't go beyond that, it is a self contained document, why would you go any further, but there is a website flagged up in there where you can go and there is a more broader description of conflict of interest there which does include potential or perceived conflicts of interest, which no one ever went to. Why would you do it? You have got it in front of you. Now there is a very big difference. Anything that would embarrass you is the active move, OK, it is what would embarrass me, so I can think what would embarrass me, and I can make a decision about that. What others might perceive to be a conflict of interest is myriad, it goes on forever. You have to put yourself in the third person and think what might someone else with their various views and biases construe to be a conflict of interest, and that is massive, where does that end? So that is a huge conceptual leap in terms as to what you would disclose, and there was no formal way for doing it at the time. Now you have a document where you fill in the boxes, saying no shares, no this, no that. That is very straight foreword, but in those days it wasn't, it was highly ambiguous, and it was always my intention, and always was disclosed, when there was a direct funding for a study, a grant giving body, or in this case the Legal Aid Board, and so in the viral study it was disclosed, 'this study was supported in part by the Legal Aid Board, and Dr Wakefield is acting as an expert in the MMR litigation', that is an easy one as it goes, but in the Lancet study I felt no need to disclose it at all, and neither did any of my colleagues who knew that I was involved with the Legal aid Board on behalf of some of these children. So that was a difficult moment but it was a difference of opinion, he thought I should have disclosed it. I felt at the time that I didn't, now in retrospect, having seen this new document about perceived conflict I can see that it should have been disclosed, but there was no dishonesty, and he was good enough to say there was no intent to deceive, 'when Dr Wakefield was asked about it he was entirely open, he said yes there was this grant'. We got into an argument and debate about what was or wasn't a conflict of interest, but there was absolutely no intent to deceive and the charge is dishonesty, so he was extremely helpful in this as much he said, no this was not dishonest, this was a genuine difference of opinion, and so that then largely resolved. Question 3: Dr Salisbury calls the the GMC ! Where does it leave the GMC if you are not guilty? Very good question on a very broad front. They have some tough decisions to make. One on the level of the case itself, and have they mis-instructed their experts, are they going to have to retrench in a different set of charges. They have to take time to structure those charges and get a response from their experts. Are they going to be allowed to do that, I don't know, but it must be becoming obvious to them now that much of the original information they were given, was, had been, misconstrued, and basing their charges on that information has been in error. At another level they are under big pressure from the Department of Health, and Salisbury in particular has been calling them on a regular basis urging them to prosecute this case more vigorously against me, be nastier, be meaner, throw more in, and I know this because we get sent the unused material, and so I took the opportunity (he didn't know this, I mean you get all the telephone conversations, all the conversation between people, all the draft reports which is an interesting advantage to us), so I was able to write to Salisbury and was able to say I am now in a position to have read the unused material from the GMC, and I note your entreaties to them....He was furious, he contacted the GMC and said: " I didn't know they were going to get the unused material...you never told me, this is a disgrace! " And the wonderful thing about that is that we get the documentation of that telephone conversation as well (laughs). So, you can see they are under a great deal of political pressure to prosecute this case and it is interesting in the public domain Salisbury has said we don't want this to be seen as a vendetta on behalf of the Department of Health. So, mixed messages. PART TWO. The other dilemma they have is who do they represent in the end? Because the GMC have historically stood for the patient, the patients rights, the patients protection from, for example, medical malpractice. Well, who do they stand for now because we stand for the patients. Everything we have done is in the best interests of the children. What they are representing and prosecuting is not on behalf of the children no parent has complained against us, but on behalf of the Department of Health, on behalf of the new kid on the block, 'the greater good.' So here we have a body who has traditionally represented the patient, the victim, if you like, against the medical profession or against medical malpractice. Now they are defending the diktat of public health against the rights of the individual. So they are in a real quandary, or if they are not they should be, about quite who they represent, because I know who I represent--the individual patient. Quote Link to comment Share on other sites More sharing options...
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