GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Tuesday 15 April 2008
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
CASE OF:
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(DAY SIXTY)
(Transcript of the shorthand notes of T. A. Reed & Co.
Tel No: 01992 465900)
A P P E A R A N C E S
MS SALLY SMITH QC and MR CHRIS MELLOR and MR OWAIN THOMAS of counsel, instructed by Messrs Field Fisher Waterhouse, solicitors, appeared on behalf of the General Medical Council.
MR KIERAN COONAN QC and MR NEIL SHELDON of counsel, instructed by Messrs RadcliffesLeBrasseur, Solicitors, appeared on behalf of Dr Wakefield, who was not present.
MR STEPHEN MILLER QC and MS ANDREA LINDSAY-STRUGO of counsel, instructed by Messrs Eastwoods, Solicitors, appeared on behalf of Professor Walker-Smith, who was present.
MR ADRIAN HOPKINS QC and MR RICHARD PARTRIDGE of counsel, instructed by Messrs Berrymans, Solicitors, appeared on behalf of Professor Murch, who was present.
I N D E X
Page No
ANDREW JEREMY WAKEFIELD, continued
Cross-examined by MS SMITH 1
THE CHAIRMAN: Good morning, everyone. Ms Smith.
ANDREW JEREMY WAKEFIELD
Cross-examined by MS SMITH, continued
Q Thank you, sir. Dr Wakefield, we had reached the point last night where I had asked you a number of questions, you will recall, about the actual format of the ethics committee application and I had turned on to the subsequent enquiries that were made in relation to that application. I was going to ask you, if I may, about the letter that was written by Professor Walker-Smith in FTP1 at page 291. Just to remind the Panel, I know that you will recall, this is the letter that was written in response to the letter that has been produced in fact by Professor Walker-Smith and is at page 265a of the bundle, the letter from Dr Pegg. You can look at it if it helps you to put the letter I am going to ask you about into context, the letter from Dr Pegg saying that it is an intensive regime, unpleasant investigations and asking for confirmation that they were part of the normal care of the child.
If we then look together at 291, in that letter Professor Walker-Smith confirms that the tests were clinically indicated, and I will ask him about that, and he then says that the children suffered from a disease with a “hopeless prognosis” in relation to their cerebral disintegrative disorder. Whatever may be the position – and we will come on to this very shortly – on whether 172-96 covered The Lancet children, I think you will agree that this letter is indeed referring to The Lancet children because if you look at the rest of it, it says:
“We have so far investigated five such children on a clinical need basis … One child has already had a significant response to enteral feeding.”
If it assists you to look at D8, which is your list of investigations, that is indeed correct, Professor Walker-Smith had seen five, numbers 1, 2, 3, 4 and 6. Would you accept that?
A Correct.
Q It is also the case that the reference to the child who has shown a response to enteral feeding, the only child who is recorded in the records as having had enteral feeding was Child 2.
A He was the only child who received enteral feeding, yes.
Q So we know that Professor Walker-Smith is writing in that letter to Dr Pegg to explain to the ethics committee the rationale for 172-96 by reference to those first five children, the first five of The Lancet children, is that correct?
A Yes, he is reporting the clinical experience in the first five children that provide the clinical rationale in answer to Dr Pegg’s question.
Q He says they have been under-investigated given their devastating condition and that they suffer from a disintegrative disorder with a hopeless prognosis – we can see that in the letter. This is a letter which was copied to you, is that correct? We see that on the next page.
A That is correct.
Q If we can just deal with the representations that he had made one by one, please, with regard to the investigations and the fact that Professor Walker-Smith says they had been under-investigated, you were well aware were you not that these five children – 1, 2, 3, 4 and 6 – had had extensive investigations of one kind or another; I am very happy to go through the precise nature of them, but investigations prior to referral to the Royal Free.
A Yes, indeed some of them had.
Q In respect of two of them you would have known that they had been seen by paediatric neurologists.
A I am not sure that I specifically would have known that but I cannot remember.
Q I have told us you had this contact with the parents when they telephoned you in relation to referral; they told you, did they not, of their quest so far in relation to what was wrong with their children who they had seen – in broad terms at least.
A They gave me the history in broad terms but I cannot remember the specific details in relation to who they may or may not have seen.
Q But you were aware at least that other hospitals and other consultants had been involved in their care.
A Yes.
Q Equally, as far as the suggestion that they suffered from disintegrative disorder with a hopeless prognosis is concerned, you were aware, were you not, that that could not describe the diagnosis in these five children, numbers 1, 2, 3, 4 and 6, either when they came to the Royal Free or in respect of those who had some sort of assessment at the Royal Free, after the Royal Free. That was not an accurate representation as to their diagnosis.
A I think that based upon the account of disintegrative disorder given to us by Mark Berelowitz it was our perception that they may have such a diagnosis until relatively late in the process, I believe as late as perhaps December 1996.
Q Doctor, by this time we are talking not about some generic description of disintegrative disorder, we are talking about five children whom you have said were being seen on a clinical basis, so we are talking about individuals, are we not, with individual psychiatric conditions? Specific children.
A The specific five children, yes.
Q As far as those specific five children are concerned perhaps I can just go through them with you, and I hope you will accept – I can go to the records if you wish me to – as far number 1 was concerned that child was never seen by Dr Berelowitz at all and came to the Royal Free with a diagnosis of autism. As far as number 2 was concerned, Dr Berelowitz saw him and said that his condition was “typical of autism”. As far as number 3 was concerned, never seen by Dr Berelowitz at all and came to the Royal Free with a diagnosis of “autistic nature difficulties”. As far as number 4 was concerned, never seen by Dr Berelowitz and came with a diagnosis of “possible autism” and as far as number 6 is concerned, was seen by Dr Berelowitz who said that the child had Asperger’s, i.e. I think you will accept the very mild end of the spectrum of autistic disorders. In those circumstances, and I am not now asking you about some generic definition, I am asking you about five children who you say were seen on a clinical basis – how could they be described as children who suffered from disintegrative disorder with a hopeless prognosis, either on the basis of what they came with or on the basis of what you found at the Royal Free?
A I think that based again on what we had been told about the element in particular of regression, but in addition to gastrointestinal elements such as secondary incontinence or chronic gastrointestinal problems, features such as ataxia – unsteadiness, clumsiness – we were still of the belief, based upon what we had been told, that there was a possible diagnosis of disintegrative disorder. This is a clinical matter but it is a fact that the majority of children with disintegrative disorder are in fact diagnosed with autism; it is only following expert review that the actual diagnosis of disintegrative disorder is teased out from the rest of the autistic spectrum, but certainly at that stage we were still of the opinion in light of those clinical features that these children had a possible disintegrative disorder.
Q Dr Wakefield, yesterday you told the Panel that you had no expertise in child psychiatry at all and you told us that you were reliant upon the definition that you were given by Dr Berelowitz with reference to Professor Rutter’s book and, as I understand it, with some further adjustments by Dr Berelowitz. I further told us that Professor Walker-Smith was the one who made the clinical decision as to whether it was appropriate for these children to see Dr Berelowitz; that is what you told us yesterday, is that correct?
A That is correct.
Q In those circumstances how can you say today to the Panel that regardless of what Dr Berelowitz thought you were of the view – you collectively – that these five children showed indications of disintegrative disorder with a hopeless prognosis. Upon what basis can you possibly express that view?
A I did not express that view at the time. This is Professor Walker-Smith’s letter.
Q Oh, I see, it is Professor Walker-Smith’s fault, is it, if Dr Berelowitz sees these children and gives a diagnosis which bears no resemblance to disintegrative disorder and then a letter is written to the ethics committee saying they all have disintegrative disorder.
A I am merely stating matters of fact. I am not blaming anyone, this is Professor Walker-Smith’s letter. Nonetheless, once again, based upon the clinical features of regression we believed that the possible diagnosis of disintegrative disorder subsumed under the autistic spectrum may still be a relevant working diagnosis.
Q I were copied into this letter and you must have known that it was an important letter as far as the ethics committee were concerned.
A I did not – I am sorry. Yes.
Q Is that correct, you realised it was an important letter as far as the ethics committee were concerned?
A In terms of the justification, the reiteration of the justification for the clinical investigations based upon clinical need, yes, I did.
Q We can assume, from the fact that you did not put the ethics committee right in any way, that you agreed with its contents.
A At that stage I had no reason to argue with its contents.
Q I see, if the justification for lumbar puncture depended on an assessment of hopeless prognosis in the minds of the ethics committee, that did not match the condition of these children who were being used as an example to the ethics committee.
A The justification for lumbar puncture, decided long in advance of this matter, was for the exclusion principally of a mitochondrial cytopathy plus a range of other clinical tests. That was decided in discussion with Dr Thomson, Dr Harvey and the rest of the clinical team. This was a clinical matter and not something in which I had any involvement.
Q Except, Doctor, that the letter says nothing in relation to that but seems to be suggesting – and we remember that this is a letter in response to a letter where concerns are expressed as to the unpleasant investigations that these children are going to have to undergo – that these investigations were justifiable because the children suffered from a disease with a hopeless prognosis in relation to their cerebral disintegrative disorder. That was just wrong, and misleading, was it not?
A No, it was not. It is not my letter and once again, based upon the clinical history of regression, there was the perception that these children had the possible diagnosis of a disintegrative disorder. The hopeless prognosis I believe was encapsulated in the fact that despite seeing these children some years after their regression there had been absolutely no evidence of improvement. In fact, in some of the children there had been evidence of further deterioration; their prognosis according to that perception was understandably and perhaps correctly referred to as hopeless in view of the circumstances at the time.
Q So as far as those children whom Dr Berelowitz saw are concerned – that is numbers 2 and 6, the others had not seen him at all – as far as those two were concerned you were ignoring the fact that he said that one of them had autism and one of them had Asperger’s, were you?
A I was not ignoring anything; I did not write this letter, I did not describe them as such. I was still under the impression, based upon what Dr Berelowitz had said, that under the autistic spectrum these children manifest signs and symptoms of a disintegrative disorder, that is loss of acquired skill.
Q When you say you were under the impression are you saying that Professor Walker-Smith and his clinical team, having investigated five of these children, far from telling you what diagnosis Dr Berelowitz had come to told you that they were all suffering from disintegrative disorder?
A Sorry, that Dr Berelowitz told me they were suffering?
Q No. I said you were under the impression that they were all suffering from disintegrative disorder. We know that Dr Berelowitz does not say that in either of the two letters he writes in respect of the only two children he had seen, so what I am asking you is whether you are saying that Professor Walker-Smith and his clinical team, having seen five of these children, had given you the impression that they were all suffering from disintegrative disorder?
A No, I did not say that; what I said was that I was under the impression that the clinical diagnosis was consistent with a differential diagnosis that included disintegrative disorder based upon the features of regression, in particular, that had been identified to us by Dr Berelowitz. That was as far as my understanding went and I am afraid in light of the fact that this is not my letter, I did not write it to the ethics committee, I can shed no further light on that.
Q We will have to revert to that, Doctor, when we look at the letters which were directed directly to you by Dr Berelowitz with these diagnoses, but that is your position on this letter at the moment, is it?
A It is.
Q As far as the investigations are concerned, where Professor Walker-Smith says they had been under-investigated, as I understand it he is saying both gastrointestinally and as far as their cerebral disorders are concerned, you knew that that did not reflect the realities of the situation as well, did you not, because these children I suggest had been investigated by other consultants in other hospitals.
A To quote Professor Walker-Smith,
“They have often not had the level of investigation which we would regard as adequate for a child presenting with such a devastating condition”.
I think that is an accurate reflection of his perception, certainly, as a gastroenterologist in light of the fact that, despite the fact that they had what appeared to be chronic gastrointestinal symptoms, those had in fact received little attention.
Q The point was, was it not, Dr Wakefield, that what you thought that you – you collectively – could add was that you wanted to explore the link between the gastrointestinal symptoms and the behavioural symptoms and vaccination. In other words, you were doing something new with them. I wanted to involve in a piece of research that no one else had done.
A The concern for these children, as evidenced by the first presentation of Child 2 in May 1995, was for their clinical well-being. The research aspects were entirely an adjunct to that. I am afraid it plumbs the depths of cynicism that I am unable to go to to suggest that we simply wanted to experiment on these children. The idea that one of the world’s most eminent paediatric gastroenterologists and his team would even countenance such a thing is extraordinary. The clinical well-being of the children came first and foremost, and everything else was subsidiary to that, and the reflections in these letters of Professor Walker-Smith and, indeed, if we come that myself, were honestly held at the time.
Q Doctor, no one is cynically suggesting, as you put it, that you experimented on these children, and you are very well aware of that if you had heard the way in which this case was opened. What is being suggested is that if you conduct research projects on vulnerable children, you should comply with the same rules in relation to the research ethics committee as apply to the rest of the scientific community. I suggest to you that in countenancing letters of this kind, you were not doing that. I were leading the ethics committee astray by countenancing this letter, which I accept you did not write, because it was being sent to them as reassurance in relation to what they had already identified was an unpleasant, highly invasive set of tests. They get this reassurance, and I am suggesting to you that that reassurance is plainly, on the face of it, misleading because you say these children had disintegrative disorder when you knew in respect of these five that they did not.
A Ms Smith, I did not say, and let me confirm to the Panel it is not my place to say, I had not the experience to say, and I did not say that these children had disintegrative disorder. I am simply not in a position to do that.
Q No. I allowed ---
A According to the information that we had been provided with from experts in the field it was part of the differential diagnosis and the fact, as at least I saw it, of the regression, their loss of acquired skills, then disintegrative disorder remained part of that differential diagnosis.
Q Doctor, I am not going to labour this because I am sure the Panel have got it, but the fact is that the experts in this field to whom you keep referring were Dr Berelowitz, and we are now talking about five children, two of whom had been seen by him, the rest of whom had not, who did not have diagnoses of disintegrative disorder, and that is just the fact, is it not? If he is the expert you are relying on, having relied on him in relation to the generic definition, you then choose to ignore him when he gives you individual diagnoses which apparently did not suit the hypothesis that you were investigating?
A Not at all. Again, the impression at the time was that based upon the clinical features of their disorder – and again I am not an expert – I was following the guidelines laid down by Dr Berelowitz, that it was on the differential diagnosis with what these children were suffering from. That came to be revised with time as we began to understand more about this. There was absolutely no intent on anyone’s part to mislead the ethics committee in this matter. Indeed, we attempted and were open at all times, as the documentation shown to the ethics committee, about the findings.
Q We have seen that piece of documentation, doctor. As far as the rest of the communications at that time are concerned, I will deal with them briefly. I think you do accept that although not copied to you, but just to remind the Panel, there is a letter at page 313 first of all which was the permission which we have now heard was an error; but you accept, if we go on to page 358, which was the letter giving the approvals with the conditions, you accept that, although not copied to you, you would have seen that letter. It is page 358.
A Yes.
Q The questions I have asked you in respect of the letter that we have just looked at in some detail take me on to consider your contention that The Lancet children were not part of 172/96, and that is what I want now to explore with you a bit further. As I understand it, your contention is that 172/96 did not cover The Lancet children. I say The Lancet paper was a preliminary study, done under the provisions of a previous standing approval that Professor Walker-Smith had for extra intestinal biopsies which had the number 162/95. Is that correct?
A That is correct.
Q So you are accepting that some research was done on The Lancet children by you, but you say that that research was simply the histology done under the previous approval and not under 172/96?
A That is correct.
Q I want to look with you at some of the evidence which I suggest to you is utterly contrary to that proposition, and there are three lots of it. I will tell you what they are so that we can work through them. First of all I am going to look at the ethics committee documentation and the subsequent correspondence that we have just been looking at but for that purpose; then with the correspondence between you and others at the Royal Free dealing with 172/96 and then with what you and the other responsible consultants have subsequently had to say about The Lancet paper. I will tell you in each section so you know where we are. First of all, just asking you about the ethics committee documents and the subsequent documentation, correspondence with the ethics committee, if you have it in front of you just in case you need to look at it, it is I1 at page 200. There is no reference, I think you would accept, anywhere in that ethics committee application to any research being conduct already under some previous permission?
A Correct.
Q I were asked in particular about the controls. I am just going to find the appropriate paragraph. It is page 209, where you were asked if there were any controls in relation to the study.
A Yes.
Q And controls, just so the Panel understands it, would be in this context normal pieces of tissue to compare – comparative pieces of tissues to compare with the ones that came from the children you were investigating. Would that be correct?
A Normal samples, yes.
Q And you expressly told us – and that is Day 48/54 if anyone one wants to look – the reason that you said there were no controls because you ready had 162/95 approval?
A Yes. Archival controls were available for comparison, so there was no need in this study to seek further controls, to include further children.
Q That would have been the obvious place, would it not, to indicate to the ethics committee that you were using controls, but that those controls were covered by a previous approval?
A The purpose of providing the answer “Nil” is to indicate to the ethics committee that no further control children will be participating in this study.
Q I told us yesterday, Dr Wakefield, how the ethics committee had to be informed of everything, including as I understand it, you are saying, all the clinical investigations and the risks and benefits attached to those clinical investigations, why is it that you think that they would not wish to have a piece of information which indicated to them, with the number attached to it, the previous ethics committee application under which you envisaged you were working.
A Because at the time, prior to the Human Tissue Act, the ethics committee was concerned with the prospective procurement of samples from children, or patients, and was not concerned with the retrospective analysis of tissues held in an archive.
Q If we look down at paragraph 11, we see there is a specific reference there to the need for five additional biopsies were patient. Is that correct for research purposes?
A That is correct.
Q I say that all histology that you carried out in the clinical scientific protocol was covered by the old generic approval, 162/95?
A Yes, it was.
Q How could you do that when 162/95 only asked for two biopsies per child? Where did the rest come from? It had to come from the same child.
A It may be worth looking at the document 162/95, but what it allows is the analysis of biopsies, and it refers to both the extra biopsies taken and it refers to the biopsies that are taken routinely. The conduct of the detailed histological analysis was a review of those slides, those sections that had been cut from the intestinal biopsies that had been used for routine purposes. In other words, no further tissues were used or taken. It was an analysis down the microscope of the existing sections from that patient.
Q Doctor, the tissues that are taken from the patient for the standard histological analysis are taken for clinical reasons and the analysis on them is clinical. Is that correct? In the normal course of events, if you take a sample from a colonoscopy?
A Yes. In the normal course of events what you do is, you take a biopsy that may measure, for example, 3x3x3 mm cubed, and that is embedded in paraffin wax and a thin section is cut from it. That leaves a great deal of tissue behind for further analysis; it does not require any further intervention in the patient and the histology is undertaken on that section. In this instance, the review – the detailed review – of the histopathology under the guidance of Dr Paul Dhillon was taken on that section that had already been taken for the purpose of clinical diagnosis.
Q If that is the case, why are you telling us that it was covered by 162/95?
A Because it was a research element; because it required something over and above the routine clinical analysis. It also required comparison, as you will see in the paper or involved comparison, with biopsies from five children provided by Dr Paula Demizio from St Bartholomew’s Hospital, taken by Professor Walker-Smith’s team during his time there in order to establish what an independent source considered as absolutely normal. Those comparative analyses reasonably constituted research and were not part of routine clinical practice.
Q Can I just take you back, please, to 162/95. I told the Panel that with regard to 162/95, that covered you for the research elements of the histology that you did in The Lancet paper?
A That is correct.
Q And 162/95, as we know, allows two extra biopsies to be taken for research purposes.
A Can we --- It may help.
Q We can look at it, if you want to look at it, but that is what it says. It is at page 86b. Please see 86c. 86b is the consent form. Page 86c gives the permission.
“The taking of two extra mucosal biopsies for research purposes during the course of colonoscopy in children.”
A That is my understanding of this document.
“Your child has been referred for diagnostic colonoscopy. Several small pieces of tissue (biopsies) are taken during the procedure (for) diagnostic purposes. Chronic inflammatory bowel diseases are still little understood and their cause is unknown. It is therefore of great value for laboratory research to have such biopsies available to study how inflammation in the bowel develops and is influenced by treatment. Your permission is asked to agree for two extra biopsies to be taken for these purposes.”
In other words, it embraces all of the biopsies that the child has had taken, both the routine biopsies and the two extra biopsies. That is my understanding.
Q But now you are suggesting that you did research on the routine biopsy?
A That is absolutely right. There is a misunderstanding here. Let me try and explain. A piece of tissue is taken and from that tissue a thin section is cut for diagnostic purposes. The remainder of the tissue goes into the tissue archive and is held for some time in the department of histopathology. There are techniques which can be applied to that remaining tissue, such as immuno-histochemistry, which enable you, by cutting further sections and applying that technique, to conduct research. The great majority of my research, particularly in I disease and latterly in the children with autism, involved just such a process – taking serial sections from the existing block taken for routine purposes for research analyses. That is entirely accepted and part of routine experimental practice.
Q So you are saying that you did research on the biopsies which were harvested during the clinical procedure for clinical reasons for clinical analysis, you are saying you did a research process on top of that?
A That is right. There were also biopsies taken which were frozen. This is a different procedure. Rather than being preserved in formalin and paraffin embedded, they are put into liquid nitrogen and frozen, and maintained at a very low temperature. Those biopsies are suitable for a different type of analysis, such as measles virus detection, looking by I.
Q But in your application to the ethics committee, you were asking for permission for five additional biopsies, i.e. additional to those taken during normal procedure. I am sorry – I am back on page 209.
A That is correct. A broader range of tests were envisaged in the 172/96 and therefore it was intended to take further biopsies from the colon in particular.
Q There is no mention, I think you would accept, in this ethics committee application to a pilot study being underway prior to the application?
A No, there is not, but the pilot study is referred to explicitly in my letter to the ethics committee in particular.
Q We will go on to look at that, Dr Wakefield; you may wish to look at it line by line. I do not accept that, but what I am suggesting to you is that the ethics committee are told that, at this stage, when you put in the application, the only information there given is that the procedures were clinically indicated and to be seen by virtue of clinical need. I do not say, “We have already underway a pilot study”, when you make this application to the ethics committee. That is just a fact, is it not?
A That is a fact.
Q Perhaps we could look at D2, tab 12, please, which is your table. I want to make it clear first of all, as I think you appreciate, doctor, that we do not accept your analysis as it is set out in this table as to what did or did not require approval, because we say, as you appreciate, that all these investigations were research investigations under 172-96; but I want to test what you are contending was the position. If we look at the second page, these are what you acknowledge to be the research tests and, as I understand it, you are saying that the 162-95 approval covered everything down to the europsychiatric studies by Dr Berelowitz. Is that correct?
A Correct.
Q And that the rest of them, you say, were 172-96. If we look at the references to the page numbers that you have put down at the opposite side, under those tests which you say were 172-96 tests – do you see where I am? The page references?
A I do.
Q They are all references to the ethics committee protocol, are they not? Page 221, 221, 223, 222 – those page numbers?
A That is correct.
Q Why did you need to give information in relation to the tests covered by 162 95 to the ethics committee if you say they were all covered by a previous approval?
A It is a fact that those tests were covered by a previous approval; in other words, the ethical conduct of research on those biopsies was undertaken. The study that we envisaged was a circumscribed study, which we felt we needed to get an approval for and we included in those – I included – the various studies in which I was involved: the research studies.
Q But if you include all those which you have listed under 162-95, all the top lot down to the europsychiatric studies, you say they were covered by 162-95, you include them all in the ethics committee application that you make, and yet you nowhere mention that they were covered by a previous approval.
A I did not consider it was necessary to make it clear to Dr Pegg, who had already awarded 162-95, that that was the case. He was intimately aware of that fact since he had made the award to Professor Walker-Smith. Here we are trying to set out in, as I say, a circumscribed, comprehensive document, the tests that it is intended we would undertake.
Q But if you know at the time exactly what you are asking for permission for, doctor, surely it is obvious information to tell them what you contend is previously approved?
A One of the differences relates to, for example, the number of biopsies that might be required; so, in 162-95, it is two extra biopsies. It was felt in our discussions that, such was the scope for further investigation of biopsies, five would be required. Clearly that additional set of biopsies would require a revision of the approval, or a novel approval; and in this case that is what was done.
Q I see, you were aware, were you not, that Dr Pegg made a stipulation that only children enrolled after 18 December were to be included in the 172-96 study?
A Correct.
Q And at no point was he informed, as you have accepted, that, as you now say, a pilot study based on the same protocol was already underway in respect of nearly all the investigations set out in the protocol, including the research investigations – because you said you were doing tissue analysis.
A What was made clear – and perhaps we might go to the letter – in my letter to Dr Pegg was that a pilot study was underway. It was absolutely explicit and evident to him that these children could not have been part of 172-96, because he gave the cut off date of 18 December and I pointed out to him that, by that stage, nine children had been seen and evaluated. This was my understanding at the time, and I gave him the findings, at least a summary of the findings, in those children. So he was aware, at that time and previously, according to Professor Walker-Smith’s correspondence with him, of a pilot study that was going on and what the results of that clinical pilot study were. He had already approved the analysis of biopsies for research purposes under 162 95 and there was no further need at that stage to appraise him or give him an update of that. That was not what the purpose of the correspondence was for.
Q Doctor, I will take you on to your letter in a moment but, although you say you appraised him, you say, at the time, that letter was February 1997 – and I am presently asking you why, if this was all understood by you, in the intricate terms in which you have now expressed it, we see no reference at all to previous permissions in this ethics committee application, when you accept that you must have known that it was highly material, given his concern that the ethics committee approval for any research was to go from a particular date. He would need to know if there was research going on under a previous approval, would he not?
A No. Dr Pegg’s concern was not for the conduct of research on biopsies. Dr Pegg’s concern – or the concerns expressed by, not Dr Pegg but by one of the lay members of the ethics committee and communicated to Professor Walker-Smith by Dr Pegg as chairman – was as to the clinical nature or otherwise of the investigations, not for the research on biopsies.
Q We will be going on a litter later, Dr Wakefield, about what you really knew about 162-95 – and it may be that this question is one you cannot answer, in which case you will have to tell us so – but 162-95 was a generic permission and was a pretty standard one in an academic institution, is that not correct?
A I am not sure what the meaning of “generic” is in this case. It is an unusual one, inasmuch as it addresses an esoteric question. It contains both clinical and research elements. To that extent it has that in common with many other applications.
Q I am sorry, I think we may be misunderstanding each other. 162-95, the permission that was given under 162-95, applied across the whole department and I am suggesting to you – and you may be unable to answer it, given what you have told us about what you know about ethics committees’ applications – that it is a standard application in respect of an academic department; and if you had looked in the records of any child who was seen at the Royal Free at that time, you would see a consent form for 162-95. In other words, a standard consent to an extra two biopsies.
A Yes, I think it was actually quite unusual – I do not have any experience of this or did not at that time, but ---
Q May I stop you? If you have no experience of it, doctor, I do not think your views as to whether it is usual or unusual will help us very far.
MR COONAN: Can he be permitted to answer?
MS SMITH: If he has no experience ---
A Simply to say that, as Dr Pegg has said in his evidence, Professor Walker Smith was somewhat ahead of his time; that he had proactively enacted ---
Q I am sorry, I am going to stop you there, and if Mr Coonan wants to make a fuss about it, perhaps the Legal Assessor can express a view. But, given that this is a witness of fact, giving us little summaries about what previous witnesses have said, when he has just told us that he has no experience of whether it is a usual or an unusual situation, does not seem to me to be appropriate evidence for this witness to give, and that is why I was stopping him.
MR COONAN: I do not want to make a fuss, either here or at any time, but, once you start embarking on cross-examination of this nature, you must give every possible liberty to the witness to answer. If his evidence is circumscribed, on examination, by a lack of experience then the Panel will give appropriate weight to it; but, in order for Dr Wakefield to acquit himself in the best possible way, the Panel, I suggest respectfully, should hear what he has to say and then apply such weight to it as is appropriate in due course.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: Had you finished what you were saying on that topic anyway, Dr Wakefield?
A Only to say that Ms Smith had said it was a general – I forget her precise term – application that other departments might use. No, I think it was not. I think it was unusual and represented the proactive approach of Professor Walker-Smith to the issue of ethics.
Q That is what you understood it to be?
A It is.
Q Very well. I think it can stop there.
MS SMITH: Now we will turn on to the letter that you wanted to look at, doctor, which is at 366aa. Doctor, I suggest to you that, on any normal construction, that letter refers throughout to Project 172-96, and the reference that you attach so much importance to in the second paragraph to the pilot study is plainly a reference to 172 96; in other words, the first children that you had already seen under that study.
A Ms Smith – or, to the Panel – how can that possibly be? It cannot be logically. Dr Pegg has made it clear that there is a cut-off date of 18 December, which has been accepted and with which we, as a collaborative team, have no issue at all. Here he is being told explicitly that children have been investigated and evaluated prior to that date. How can it possibly be? The two matters are wholly irreconcilable. It cannot possibly be the case that these children were investigated under 172-96. That would be self evident to Dr Pegg and his committee.
Q Doctor, we know that nine children had been investigated…(Pause) Doctor, the reference to the pilot study, which you place such reliance on, in the second paragraph, is a reference to the first children you had seen under that study. If we look at the top of the letter,
“Further to your recent letter…our study A new paediatric syndrome: enteritis and disintegrative disorder…following I vaccination, we would suggest that the following amendments be made….”
Then you go on, “The pilot study has demonstrated….” I have not told Dr Pegg about any other study, have you?
A We refer there, in the first paragraph – I refer – to one study, for our study, and then give the title. In the second paragraph, I say “The pilot study…” and, again, it is wholly inconsistent with the facts. Dr Pegg having given approval for inclusion of children beyond 18 December, and being presented with this letter that makes it clear to him that children have been investigated clinically according to a pilot study, must, by definition, have preceded the onset of 172-96, according to his stricture.
Q Given that I think we would all agree that the person who has to understand this is Dr Pegg – I mean, he is the person it is important to make it clear to, is he not? I would accept that, would you not?
A And this is an attempt to make it clear to Dr Pegg precisely what the situation is.
Q I see, this letter does not say anywhere that the children were investigated before 18 February 1997, does it? I am sorry, 18 December 1997.
THE CHAIRMAN: 1996.
MS SMITH: 1996.
A If this is seen in conjunction with Professor Walker-Smith’s previous communication to Dr Pegg on this, the answer is that these children must have been seen before that time; and if Dr Pegg was in any doubt at all, he was able to ask the question. What Dr Pegg understood, as far as I was concerned and as far as we were all concerned, is that we were abiding by his stricture of 18 December and that these children formed part of a pilot study, which actually led to modifications of 172 96 and suggested inclusions in that protocol.
Q Doctor, I have to suggest to you that if one reads the whole letter through, on any normal understanding of that letter the first paragraph and the first section of the second paragraph are saying that, further to the permission which his committee has granted, with effect from 18 December 1996, your experience of the study so far has enabled you to reach a judgment to withdraw some of the tests – and that is the only possible construction that Dr Pegg could have put on this letter.
A I am afraid that I wholly disagree. That was not the intention of this letter. The intention of this letter was to communicate to Dr Pegg the matters of fact, and it was written in accordance with his strictures of 18 December. It lays out the fact that a pilot study – not the study referred to in the first paragraph, ‘A new paediatric syndrome’… et cetera, but the pilot study – had given us or provided clinical findings that led to modifications of the intended protocol.
Q I see, Dr Pegg is only interested, is he not, in the research elements? He does not need to know if you – you, collectively, Professor Walker-Smith’s department – had stopped undertaking clinically indicated tests.
A I agree there is something of a paradox there, but Dr Pegg in his letter to Professor Walker-Smith said that he wished to know of any changes to the protocol; and in the spirit of responding to Dr Pegg according to that request, that is being described here.
Q Doctor, you say it is something of a paradox. With one breath you are telling us, “Oh, well, I accept that is a paradox but we include it because we feel that Dr Pegg has to know every detail of what we are doing”, in effect – all the details relating to it. That is what you tell us with one breath; then, in the next breath, you tell us, “Oh, well, we didn’t tell him about the previous 162-95 application under which we were conducting research, because that wasn’t something he needed to know”. Which is it? Did you feel under an obligation to inform him as to everything or not?
A No. Let me be absolutely specific as to Dr Pegg’s request. His request was to be aware of changes made to the proposed protocol, not whether there was evidence of pre existing protocols: changes. Not of everything that Ms Smith refers to, but specifically to proposed changes to the protocol; and, in the spirit of Dr Pegg’s request, that is what we are doing.
Q In this letter you expressly refer to the withdrawal of tests which you say were clinically indicated, in other words the I and the I; so you are expressly telling him, and you accept that that was a paradox, that those clinical tests had been withdrawn, but you do not say anywhere that you are withdrawing any research tests – for instance, the complement studies, the cytokine – do you?
A No, because at that stage – firstly, it was not me who determined that these tests were clinically indicated, the I and the I, let me make that absolutely clear if it needs reiteration. That was a clinical decision made by the clinicians. Secondly, there was still at that stage every intention to conduct the scientific elements that were ultimately not conducted, that is the complement studies; there was no intention not to do it and, as I have pointed out, I flew to Hamburg to see Professor Mauff in 1997 – early in 1997 I believe – in an attempt to enlist his collaboration, so those tests were not actively withdrawn from this protocol at that stage, there was an honest attempt to continue to raise the funds for their conduct.
Q Despite the fact that you have told us that Dr Pegg needed to be informed about the research elements of the test, you never actually told him that you were not going to carry out those tests. There is nowhere in the correspondence with Dr Pegg that the research ethics committee were ever told that they were not being carried out, although you are relying on this letter in relation to other tests which you did withdraw.
A I am not sure that an active decision not to do them ever took place. This whole process was attenuated by my departure from the Royal Free and the samples on which these tests might be conducted were still, many of them, retained and they might be conducted at any stage had the funding become available to do it, so I do not think at any stage was there an active decision not to do those tests – at least according to my memory.
Q Whilst we are looking at this letter, Doctor, you specifically reserve the position in respect of the withdrawn elements of this study so that Dr Pegg is aware that they will be carried out when they are specifically indicated. If we look at the first two sentences:
“The pilot study has demonstrated that the I and I studies are all normal and therefore we feel there is no need to continue these unless specifically indicated.”
A Again, this is a clinical matter but it might relate, for example, to a patient in whom a structural abnormality of the brain was anticipated, according to the neurological findings – I can only speak in generic terms to that but that, at least in my understanding, is where the indication remained.
Q I say it is a clinical matter, Doctor, but this is a letter that you wrote, so we can assume, can we not, that you understood what you meant by these phrases?
A This was written by me to Dr Pegg as the coordinating investigator.
Q When you say we will not carry out I and I studies unless they are specifically indicated, that was a clear recognition by you, was it not, that they would not be done on research grounds as part of the protocol but that they would be done if they were indicated in the individual circumstances.
A No, again let me explain. It was a clinical decision to include these tests on the basis of the symptoms manifest by the children. When it was determined by the clinicians that they were not in fact yielding clinical information that influenced the management of the children a decision was taken by the clinicians to remove them. Had they been done for research reasons they would have continued regardless because the research question was not interested or would not have been interested, for example, in whether there was an abnormality or not. It would seek to determine, in the largest number of children possible, that there was or was not an abnormality, and that is a clear indication – an absolutely clear indication – that this was done for clinical reasons and they were removed for clinical reasons because they were not yielding information that influenced the child’s management. The caveat here, from the clinicians, is that if there were a specific clinical indication in the children for the conduct of one or both of these tests then that would potentially be done.
Q We are agreed, are we not, that if they had been clinically indicated from the outset there would have been no need whatsoever to tell Dr Pegg about them at all, about the fact that they were happening or that they were ceasing. Again, you rely on the construction of this sentence and it is absolutely plain, I suggest to you, that you were saying there that the MRIs and I had been being done under the provisions of the study and that you were not going to continue with them unless the individual circumstances demanded, i.e. unless they were clinically indicated.
A Once again Ms Smith is wrong and there is no logic to the argument. The inclusion in the protocol as set out in 172-96 is in the manner of other protocols, one that includes both the clinical and research elements since it provides a comprehensive document for the understanding of the ethics committee. That is number one. Number two is that in the spirit of the letter from Dr Pegg asking us to notify him of any changes to the ethics committee request or to the document, to the protocol, then that information was imparted to him.
Q Nonetheless, doctor, you have accepted that that paragraph contains what you describe as a paradox – an inconsistency in the position that you are now putting forward.
A The paradox, and it may be one that Dr Pegg has resolved subsequently, I do not know, is that a request is made by him and his committee for any changes to the protocol and we took that as meaning any changes and he was informed accordingly.
Q Still dealing with the ethics committee I think it is right that later, in July 1998, queries were made as to the nature of the ethics committee permissions by Professor Sir David Hull, and I just want to put that in context for the Panel by reminding them where the letter is; it is in I3 at 930. This was a letter I entirely understand you did not see, as I say I am only going to it for context for the Panel. That is the letter that Professor Zuckerman received from Professor Sir David Hull where he is asking, in broad terms – he says that he sees the investigations were approved by the ethical practices committee of the Royal Free and he asks what the ethics committee position was on the investigations. As a result of that we know, from the evidence we have heard, that Professor Zuckerman made a number of enquiries and one of them was to your head of department, Professor Pounder. Did Professor Pounder indicate to you that this query had been raised?
A I do not remember that; no, I do not think he did.
Q It would have been extraordinary, if he had not done so, would it not, Dr Wakefield, given that an enquiry is being made about a senior member of his department’s research and given that you had, as you have told us, a good relationship with him? He would have told you, would he not, do you think you could have forgotten it?
A I do not know. He was at that I meeting and he had the details, as Professor Sir David Hull had the details, so he may have based his answer upon what he gleaned from the I meeting. I do not remember talking to Professor Pounder about this.
Q I are telling us that as far as you recall your head of department had a serious enquiry through the dean by an outsider, who was at one time at least the President of the British Paediatric Society, and as far as you recall he did not relay that to you.
A What I am saying is that I have no memory of it and I am relying, as far as I can, upon the documentary evidence and particularly that that involves me directly.
Q If we go to page 935 we see the answer by Professor Pounder to Professor Zuckerman:
“Thank you for your letter of 10 July enclosing a copy of Sir David Hull’s letter of the 6 July [the letter I have just been to].
As you know, I am not directly involved with the studies into children with autism although I have a considerable interest in this work and appreciation of the various protocols involved.
The original study, published in The Lancet earlier this year, was a research protocol investigating the possible link between autism and abnormal bowel function. That was a research study involving a number of invasive and non-invasive techniques and it received both approval by the ethics committee and also parental consent. At the end of that study an association was identified between autism and a new form of I. From then on, the patients have not been subject to research protocol investigation, but have been investigated according to agreed clinical guidelines. Essentially, they are being investigated like any other person presenting with I – a range of blood tests and a colonoscopy with appropriate biopsies.
I think you were one of the first to recognise the importance of the association between autism and an atypical form of I and it is this association that is now being confirmed time and again by the present investigations. I have absolutely no doubt that the present approach is ethical, and that it does not need investigation or approval by our ethical practices committee.”
That letter expressly says that Professor Pounder had an appreciation of the various protocols involved, do you accept that?
A It does say that and that will be in light of the fact that he reviewed 172-96 and signed it off.
Q Absolutely. That letter makes it absolutely clear, does it not, that the original study, published in The Lancet earlier this year had been approved by the ethics committee and covered the research investigations, invasive and non-invasive, that are in the protocol?
A No, what it makes clear is Professor Pounder’s understanding. What he says is “I am not directly involved with the studies into children with autism”.
Q And as you have rightly said he is the one who signed off project 172-96 and it would appear to be the case that he is under the understanding that 172-96 covered the original study published in The Lancet namely the first 12 who were part of a research protocol, and that thereafter patients were seen on a different basis. That, Dr Wakefield, is I suggest to you precisely right.
A No, it is not, it is in fact wrong on many, many counts. I am afraid that Professor Pounder has made several mistakes, in particular, for example, in relation to the continuation of the studies which did involve continued research on my part, analysis of the biopsies for example. So the letter is riven with error and in light of that it is very likely that he did not consult with me when answering this question but was basin it upon his knowledge of having read 172-96. There is a whole swathe of correspondence to which Professor Pounder was not privy, did not read, was not aware of – for example, my letter to Dr Pegg of the ethics committee outlining the pilot study – and he has written this letter in error.
Q I are saying that your head of department, whom you have described as a friend and someone with whom you collaborated closely, answering an enquiry from an eminent paediatrician about the ethical position in respect of research on small children, passed on to him by his boss, the dean, did not check with you and got it all wrong; that is what you are saying.
A I am afraid that the contents of this letter, which is not mine, are demonstrably in error.
Q He got it wrong in respect of the very ethics committee application which you have told us was the first one you had done on your own, signed off by him, it is all wrong.
A He has placed the wrong interpretation on the sequence of events; that is self-evident when one looks at the correspondence with Dr Pegg from both Professor Walker-Smith and myself. Had Professor Pounder consulted with Dr Pegg, or me or Professor Walker-Smith and obtained that documentation then the picture would have become very much more clear to him. He was not directly involved – as I say, there was a large amount of correspondence to which he was not privy and this may well be his response, based upon his knowledge gleaned from the I meeting.
Q If we go on we see Professor Walker-Smith’s reply in relation to the same concerns raised by Professor Hull and that is at 937. If we look at 938 we see that this is a letter that was copied to you, is that correct?
A That is correct.
Q He says:
“Dear Arie
Thank you for sending me a copy of Sir David Hull’s letter.
In relation to his specific points. The original study covered by the ethical committee is now complete.”
He then expresses his views about the initial findings and says that he has written about those to The Lancet and he says “Subsequently …” – I suggest subsequently to the original study – “… children have been seen on the basis of clinical need, referred …” et cetera. I am happy to read anything else out in the letter that you wish me to but I suggest to you that that letter clearly indicates that the ethics committee approval was obtained in respect of The Lancet children.
A The date of this letter, as you can see, is 14 July 1998 and by that stage many children had been seen, way beyond the original 12 seen in The Lancet. Again, this is Professor Walker-Smith’s letter and he will speak to it, but it is absolutely certain that by that stage a further 25 children who would have constituted 172-96 would have been seen. I cannot say specifically to what group Professor Walker-Smith was referring, but it is certain that the statement he has made, the original study covered by the ethical committee is now complete, is entirely accurate.
Q I are saying that that referred to children after The Lancet 12, is that what you are saying?
A This is not my letter, I cannot say what Professor Walker-Smith is referring to but what I can say is that it may well be referring to that group.
Q Except that he goes on in the second sentence:
“The original study covered by the ethical committee is now complete. He is quite incorrect to state that the initial findings showed that the children did not suffer long-term bowel disorder … Whilst there has been discussion about the latter being a normal variant, I have answered this point in a letter to The Lancet …”
That is a direct reference back to the letter from Professor Sir David Hull which made the very point that he did not quite see why people were going on investigating if the initial findings had been of a normal variant, so it is a plain reference, Dr Wakefield, is it not, and accords with Professor Pounder’s letter that these children were seen under 172-96, the original study covered by the ethics committee, and subsequently – just as Professor Pounder says – they were seen on a different basis.
A No, you are confusing what the second sentence actually says; it is a direct response to the issue raised by Professor Sir David Hull which was in fact incorrect, he had no basis whatsoever on which to assume or form the opinion that these children did not suffer from long-term bowel disease, none whatsoever, it is highly likely that they did, but it is not the point that is covered in the second sentence, “The original study covered by the ethical committee is now complete.” He is referring specifically to an issue raised by Professor Sir David Hull and answering that.
Q So you were happy that this letter covered the position were you, Doctor, since it was copied to you?
A I had no reason to take issue with Professor Walker-Smith on its content.
Q I want to turn to the second section. I will remember that when I began this morning I told you that I was breaking this up into various categories of document which I am suggesting to you make it plain that The Lancet children and 172-96 are the same. I have dealt with the first, which is the ethics committee documentation and subsequent correspondence and I now want to look very briefly at the correspondence between you and others at the Royal Free Hospital actually dealing with 172-96. The first letter I want to look at is Mr Else’s letter in I1 at 192. We know from this letter that the funding had been put in place for Ms Sim’s salary, but it is not that that I want to ask you about at present. The whole point of that letter, other than to sort out the funding is to record the precise position with regard to the interaction between the research funds and the ethical approval. Is that correct? That is what Mr Else is asking about?
A Yes. His terms for accepting the grant.
Q And the title of that letter, I think you will agree, is the title of the protocol submitted to the ethics committee for project 172/96?
A Yes, it was.
Q And Mr Else does not appear to be aware anywhere in that letter that there is a pilot research study already underway?
A Clearly I did not feel there was any need to provide him with that information.
Q This –
A It was not directly relevant to the matter at hand.
Q He is expressly commenting on the fact that the children are being seen on a clinical need basis, is he not?
A That is correct.
Q And he is expressly saying that there was to be no research, i.e. no tests of investigations or procedures – so he is setting out in some considerable detail – will be done after ethical approval for the study?
A Correct.
Q
“No tests, investigations or procedures will be undertaken that are not clinical indicated but which do form part of the research study protocol, until approval for the study has been received from the Ethical Practices Sub-Committee.”
Is that correct?
A That is correct.
Q Why did you not inform him that you were already carrying our research as you now say under the protocol in a separate, preliminary pilot study?
A He does not specifically ask to see the documentation, at least as far as I am aware. He is just making sure that there are strictures in place, that there are guidelines in place, if you like, for the reasons for the basis of his accepting that funding.
Q It was very important, was it not, and he is the chief executive of the hospital and is making it clear in that letter that the funds used for research are being used for ethically approved research?
A That is correct.
Q That is what he is aiming at. The clear position is, looking at that letter, that the chief executive, Mr Else, understood that there was a research project submitted to the ethics committee which was awaiting ethics committee approval and that a group of children who were being seen were being seen for clinical reasons only. That is clearly what he is saying?
A He is saying that no part of a research study should be undertaken until it is approved by an ethics committee.
Q And yet he makes no mention of any separate preliminary studies, and no mention of any previous ethics committee approval, both of which you are saying were not the position?
A Yes, but as long as one is compliant with his letter, with the rules set out in his letter, that surely is sufficient. As long as the children are being seen on a clinical basis and as long as the analysis of biopsies has historically been undertaken under an ethical approval or will in the future be undertaken under the cover of an ethical approval, that is the issue at hand; that is his concern.
Q Dr Wakefield ---
A That was ---
Q I am sorry. Please?
A No, that is okay.
Q It is an interesting proposition that you put forward. That surely, you say, is sufficient. We have agreed that what is important to Mr Else is to know that the funds were for research, the funds which you were going to use for research were going to be used for ethically approved research. We are agreed on that?
A Yes.
Q And the clear understanding of Mr Else in this letter is that you had a research project, that it was awaiting EC approval and that meanwhile no research was being done on these children. They were being seen for clinical reasons only. Why is not Mr Else being informed by you of what you now say, which is that you were doing separate, preliminary studies under a previous ethics committee approval?
A He is saying, until approval is received. For approval of studies being received.
Q And you are saying you already had it.
A That does not preclude the possibility that there is an existing approval, which there was, to cover the research that was being undertaken as it was, indeed.
Q Why did you not just tell him that, Dr Wakefield? Why is there any difficulty or complexity about it? Why did you not just say to Mr Else, “Mr Else, this is what is happening. We have an approval and we are doing so-and-so and we are awaiting for ethics committee approval for the rest.”
A He is setting out the basis for his conditions for accepting the funding.
Q The truth is, these children were being seen under 172/96, and you told Mr Else that you were awaiting ethics committee approval for that research study?
A No. As I have said, it is wholly illogical – wholly illogical – based upon the correspondence between the ethics committee and myself and Professor Walker-Smith that these children were being seen under 172/96. It does not make any sense, and any research that was conducted on the children was at all times covered by ethical practices committee approval.
MS SMITH: Sir, I am going to turn on to another letter, and I see it is very nearly 11 o’clock. I think perhaps if you felt it was appropriate, this might be a good moment.
THE CHAIRMAN: Yes, indeed. I think it is very close to 11 o’clock. We will now adjourn for our mid-morning break and we will resume at twenty past eleven. Dr Wakefield, just to remind you once again, you are still on oath.
(The Panel adjourned for a short time)
THE CHAIRMAN: Ms Smith.
MS SMITH: Thank you, sir. I wanted to go on to look at another letter with you in the same context as those we have been previously looking at, Dr Wakefield. It is in your I2 bundle, please, at page 401. This is a letter which was written from you to the Dean, Professor Zuckerman, in March 1997. Again, it was written in the context of concerns being expressed, this time in relation to the involvement of the LAB, but I only want to ask you about one section of it at the moment. That is the first section.
“Further to our exchanges regarding the investigation of children with enterocolitis and autism, and especially the involvement of Dawbarns and the Legal Aid Board, please find enclosed all documentation relating to this matter. This includes a letter to Dawbarns from the Legal Aid Board specifying the conditions for making the award. These conditions were based upon the enclosed protocol which has been approved by the Ethics Committee of the Royal Free Hospital.”
That can only be a reference to 172/96. That enclosed protocol must have been the 172/96 protocol that had been approved by the ethics committee of the Royal Free Hospital?
A That is correct.
Q In this letter you are saying that the research study on The Lancet children, some of whom were covered, we know, by the Legal Aid Board studies that you were going to do, were based on the 172/96 protocol which had been approved by the ethics committee?
A Not necessarily. What I mean by that is that the…. Excuse me. I would like to step back a little. The Legal Aid Board pilot study, a prospective study of five children with autism and five children with I disease, was indeed covered in respect of the children with autism under 172/96. I think what I am doing here is seeing to reassurance Professor Zuckerman that the analysis of biopsies on children with autism pursuant to the Legal Aid Board pilot study is, indeed, covered under 172/96.
Q I were reassuring Professor Zuckerman that the conditions in the enclosed protocol, 172/96, which had been approved by the ethics committee, 172/96, covered the children who you were referring to, some of them The Lancet children.
A This does not preclude the possibility, in fact the actuality, that research was undertaken on the biopsies of the children in advance of 172/96 being approved or, indeed, the Legal Aid Board protocol being undertaken.
Q In that case, you were looking at them under another, you say, permission by the ethics committee, the 162/95 permission.
A Which had nothing at that stage to do with the Legal Aid Board protocol, correct.
Q And the 162/95 was not the enclosed protocol. 172/96 was the enclosed protocol?
A Because that was the one that was relevant, in my opinion, to the conduct of the Legal Aid Board pilot study.
Q Then we have two further letters which we have already been to in some considerable detail when I did the chronological overview. I am not going to through them again save to make a suggestion to you in respect of them; that I2 at page 471, which was the letter where you explained to us with regard to the various paragraphs what you meant by the use of the word “the study” and” the same study” and “this study”, if you recall. That was a letter to the director of finance, Mr Phipps. The only thing that I wanted to ask you about in that was that it refers, in the middle of the second paragraph, to the performance of the study outlined in the enclosed protocol.
“This protocol, as you will see, has been approved and passed by the Ethics Committee of the Trust.”
It is the same point; that, again, was a reference to 172/96?
A Which again was the protocol which, in my opinion, the Legal Aid Board pilot study, at least in respect of the autistic children, was conducted.
Q And there is no mention anywhere in that letter of pilot studies or of any approvals that may have preceded 172/96. Is that correct?
A Indeed, nor were they necessary.
Q If we go on to page 493, the second letter I took you to, and we see a reference at the top which I have already asked you about to the clinical study of the Legal Aid Board children, although you say it was not a clinical study, and at the bottom:
“Please find enclosed a copy of our first paper submitted to The Lancet concerning the children under investigation. This has been an extremely successful study …”
et cetera. There again, I suggest to you that that is a clear allusion to The Lancet children have been investigated under 172/96?
A No. That is incorrect, for the very reasons that I pointed out.
Q Let us go on, if we may, to look at what you and the other responsible consultants have subsequently had to say about these matters. This is the third category of documents that I was going to take you to in relation to The Lancet and 172/96. It takes the matter on considerably chronologically. I want to look, if I may, first of all at The Lancet paper itself, which is at I2, 783. Just so that we can orientate ourselves to the question that I want to ask you, if you look at the right hand column under “Patients and methods”, you list the clinical investigations – is that correct – and then the lab investigations and then the histology?
A Correct.
Q If we look at the clinical investigations and the lab investigations we see under the clinical investigations that a history was taken, including details of immunisation and exposures to infectious diseases; that psychiatric assessments were undertaken and then bowel preparation and ileocolonoscopy, I, I and lumbar puncture. In other words, those are the things that were done to the patient, if you like. Could that be fair?
A Correct.
Q And the lab investigations – I am not going to go through them all – but in summary we have a reference to thyroid function tests, I lactate tests, serum fatty acids, urinary methylmalonic acid tests and other tests arising from that, urinary creatinine and various screening tests for such matters as fragile-X and stool samples. As far as those tests are concerned, those are done in the lab?
A Yes.
Q Then immediately under those headings at page 784 in the left hand column, under the heading “Ethical approval and consent”, we see what you said there:
“Investigations were approved by the Ethical Practice Committee of the Royal Free Hospital …”.
What I want to ask you is this, Dr Wakefield. I think you would accept that representations as to the ethical approvals were an important part of the paper?
A Yes, it was.
Q It was important from the point of view of getting it published, obviously, because many journals require some sort of indication as to ethical approval – is that fair?
A Not necessarily in the context of a case series at that time. It was not necessary to have ethical approval for the conduct or presentation of a case series. That was my understanding. Nonetheless, it was necessary if there were research elements to that.
Q These children on any reckoning, leaving aside the purpose for them, had had a series of very invasive tests for small children to undergo. Would that be fair?
A Had? “Had” tends to be, at least my perception, prescriptive. On the basis of the clinical indication they were to have undergone tests which were invasive, yes.
Q A natural query by those interested in paediatric medicine is going to be the basis under which they underwent them; i.e. whether it was research or clinical; if it was research, how it could be clinically justified. That was a matter that informed readers of The Lancet paper would wish to know about.
A Yes, and sophisticated readers of this journal would know that a case series as such, or a case report, does not require ethical approval.
Q But what they are going to be interested in is how the researchers were able to find what they said they had found; in fact, the very issue that Professor Hull subsequently raised, and he indeed quoted this very paragraph from The Lancet paper. I think we can agree, can we not, that he would count as a sophisticated reader of The Lancet paper?
A Yes.
Q Anyone reading it would see that it says that investigations were approved by the Ethical Practices Committee of the Royal Free, and that parents gave their informed consent. That is what it says.
A Correct.
Q And that can only be a reference, I suggest to you, to the approvals under 172 96.
A Again, I do not necessarily see the logic of that.
Q Perhaps I can assist you ---
A Let me answer, and that is that the paper itself is a consensus document and this statement within it is a consensus statement. In other words, all of the authors have to be happy with it. I cannot answer for the other authors of this paper but I can answer for myself, and what this refers to as far as I am concerned – and as far as I was concerned at the time – is to approval for those tests, those investigations, that required ethical approval. From my perspective, that was the conduct of research, research elements – in this case the detailed histopathology – the correlation of the findings from the research with the clinical findings, and their publication in a peer reviewed format.
Q Are you suggesting, doctor, that the generic approval which you say – well, which indeed was in existence – under 162-95 to take two extra biopsies was being described there as approval for the investigations?
A As far as I was concerned, it was the element that required ethics approval and that is to what it refers. It may be the opinion of others that it is different, but I cannot speak for them. As I say, this is a consensus statement.
Q But as far as you are concerned, Dr Wakefield, you are not seriously suggesting that the word “investigations” covers an approval to take a couple of biopsies for research purposes?
A I most certainly am. If that procedure requires ethical approval, then it should be included. If it is of sufficient import that it requires ethical approval for the taking of those biopsies, then it most certainly merits inclusion in this document.
Q The whole point of giving this information is to inform, is it not? Not to obscure but to inform – or you would not bother to put it in at all.
A To inform those people who are reading this, and sophisticated in the matter, that the research elements of this study had been approved by an ethical committee.
Q But if it is your understanding that that word “investigations” was meant to cover your analysis of tissue biopsies, why does it not say, “The ethics committee had approved the analysis of tissue biopsies from children who had clinically indicated investigations”? It is perfectly simple I, is it not?
A It is a rather more longwinded way of putting what was in a summary statement, “Investigations were approved by the ethical committee”. It is a standard description and that is what was used.
Q I see, your 162-95 approval presupposed that these children were having clinical colonoscopies; in other words, you did not need permission for them.
A And therefore, in my opinion, the term “investigations” does not refer to colonoscopy.
Q Except the difficulty with that is that on the previous page we get clinical investigations and laboratory investigations. How are the readers to know that you are now referring to an extremely narrow aspect of looking at a bit of tissue under a microscope, rather than all the investigations?
A If one refers further on to the histology, one will see, in the second line of the histology, five ileo-colonic biopsy series from age-matched and site-matched controls whose report show cystologically normal mucosa were obtained for comparison. That is clearly indicative of a research element.
Q Absolutely, and I do not think we are arguing about that; but that is not covered by what you say on page 784: that investigations were approved by the Ethical Practices Committee. “Investigations” under a heading which refers to all the invasive tests on these children.
A No, it does not. That is your interpretation, Ms Smith; that is not mine, and it was not mine at the time.
Q I have to suggest to you, doctor, that your present position in relation to the ethics committee approval that you had is flatly contradictory to that statement that is made in The Lancet paper at the time.
A In fact it is entirely consistent with the statement made in The Lancet at the time.
Q Could you turn on, just in passing, to I3 at page 925? In the top right hand corner is a letter from Dr Linnell, after queries were made about this paper. We can see at the bottom that this was in May 1998, so a few months after the publication of the paper in February 1998. Dr Linnell is talking about his own particular aspect of this work.
“The previously normal children we investigated all had developmental regression and undoubted intestinal abnormalities. All those from whom we were able to obtain urine had MMA concentrations above 1.5 mg/mmol creatinine, the upper limit in our age and sex matched controls….None was receiving megadoses of vitamin C or was on a restrictive diet.”
He is making a point in relation to the research that he had done on The Lancet children, is he not?
A The measurement of methylmalonic acid in the urine is a clinical test in this indication, as I understand it; that is, children with neurological deterioration.
Q I have told us that Dr Linnell was employed on research monies, doctor. That is correct, is it not? He was employed by the Children’s Charity, is that correct?
MR COONAN: The evidence was that he was employed in two capacities; that is the evidence that was given.
MS SMITH: We will go through that. As far as the Royal Free was concerned, doctor, you told us that he had a clinical practice elsewhere and as far as the Royal Free was concerned I expressly asked you where the funding from his employment came from, and you told us from the Children’s Charity. Is that correct?
A That is correct. That does not mean that his role was exclusively research. He had an honorary appointment at the Royal Free Hospital, but from the Chelsea and Westminster he conducted both clinical and research analyses in relation to vitamin B12.
Q The investigations that he is referred to in this letter were part of the 172-96 investigations, were they not?
A They were also a part of the routine clinical investigation of children undergoing neurological deterioration – urinary methylmalonic acid.
Q So you are saying he was wearing an entirely clinical hat and was not in a research capacity?
A I am saying that he was there principally in a capacity to provide urinary methylmalonic acid metabolites analysis, which is something that equally could have been obtained from the biochemistry laboratory except that the cost would then have fallen on the National Health Service, and he was there to conduct more esoteric research tests in relation to cobalomin enzymes.
Q Under what approval was he conducting esoteric research tests?
A In fact, as I pointed out, he never actually conducted them.
Q He did not do them?
A They were never done.
Q So when you say he was there to conduct more esoteric research tests, you are saying he never did them?
A The purpose of him coming was in order to provide a comprehensive assessment of vitamin B12 abnormalities in children. In the event, because of the failure to get adequate funding for him to conduct the more esoteric tests, they were never done.
Q Of course, the Children’s Charity funding was in fact declared in The Lancet, was it not?
A That is correct.
Q Was that in relation to Dr Linnell’s ---
A Salary, yes.
Q …salary. But none the less the tests that he was doing that were written up in The Lancet, you say, were not research tests. Is that your position?
A There was some confusion about this and I am sure that is the next point that you will come on to, so I will not I it.
Q No, please. I are saying there was some confusion – what? In respect of what Dr Linnell did?
A No. In my mind, projecting back as to what the events were 13 years ago when trying to determine, in the face of various allegations made in 2004, precisely what was happening in this period in 1996 and 1997, that confusion has now been reconciled.
Q What did that confusion lead you to do, doctor?
A It caused me to go back and look again in great detail at what had happened. If you would like me to, I can talk about this in great detail now.
Q I told us that you had a confusion in your mind in relation to the urine tests which were being performed on these children, and I wanted you to tell us the nature of that confusion and why you have raised it at this point.
A Broadly, in 2004 there was a week during which a series of allegations were made that led to a great deal of confusion and disorientation. At the start of that week I was in America and the allegations, made by a freelance journalist, meant that I had to come back from America. I arrived back on the Tuesday and had a series of meetings on the Wednesday, one of which, as the Panel will now know, was at The Lancet with Richard Horton and my colleagues, Professor Walker-Smith, Dr Murch and Dr Harvey. Following that meeting we were issued with instructions to go away and to prepare a statement which addressed the respective allegations, and we were each allocated specific allegations to address. Dr Murch was asked to address the allegation that these children had not been investigated under an ethical approval and that was a falsification, in effect.
For some reason which I am not certain of, we were given a remarkably short time frame in which to reconstruct the events of 1996-97 and provide a written answer to The Lancet for publication on its website – its web version of The Lancet – that Friday. There were very few documents available to us, certainly to me, and the upshot of that experience was that Dr Murch – and he will answer to this – put together a statement which conflated 172-96 and The Lancet children. There is absolutely no criticism of Dr Murch in this matter at all; it is simply a function of the fact – and I want the Panel to try to understand – that this was an extraordinarily disorientating time, not only dealing with allegations which we believed to be false but the recrimination, the fall out between colleagues, the lack of understanding, the lack of documentation. But none the less, against this background, the statements were put together.
To an extent, in trying to reconstruct what happened at that time, in trying to determine what my state of mind was, I have, as I have said, been largely reliant upon the documentary evidence, because I have realised that memory is faulty. One of the documents that I have had available to go on was Dr Murch’s statement, which, as I have said, conflated The Lancet twelve with 172-96.
In trying to articulate my Rule 6 letter and subsequent events, I had to deal with the issue of this conflation and, in looking at The Lancet paper, the one thing that struck me at the time that might reasonably be described as research was the statistical analysis conducted on the methylmalonic acid. This was a clinical test but none the less comparison was made with normal controls, archival controls from Dr Linnell, and a statistical test was conducted. That, to my mind, was research.
In fact, the analysis of MMA on archival controls at the time, prior to the Human Tissue Act, was perfectly permissible and did not require ethical committee approval; but that was my confusion. It may be argued that the statistical analysis did require ethical approval, but I hope the Panel will accept that it is such a small matter, conducting a statistical analysis, that it is neither here nor there.
That is the issue that one has had to live with right up until the time that Professor Walker Smith introduced the letters in relation to Dr Pegg – my correspondence with Dr Pegg; and at that time, when I had seen those documents, my state of mind at the time was made clear – that I had ---
Q I am sorry, but may I stop you now? We have had a very, very long answer from you, covering an enormous amount of material, and I am quite happy that you should do that but, you are correct, you are going to go through it rather more slowly with me. I would now like to confine this to where we began, if you please, which is the urine tests. I indicated to the Panel that you had had a confusion about the urine tests and you have then given us this long answer. As I say, there are other matters that I want to ask you about but, as far as the urine tests are concerned, you are saying that you did at one time think and say that the urine tests were part of the research, is that correct – and you now are saying that was incorrect?
A It could be reasonably argued that the statistical analysis was a research element. The measurement of MMA was a clinical test. The measurement of MMA in controlled samples, archival samples, is a research test but it is one that is conducted, was conducted at the time, without the stricture of the need for ethical approval.
Q I do want to ask you about the allegations which were made against you in 2004, and perhaps we can come on to that in more general terms than simply relating to the urine tests and what you may have said about them which you now retract. I had to consider the whole issue of ethical approval, did you not, in 2004, in circumstances when the whole paper was the subject of intense scrutiny?
A My specific remit during that period was to address the allegations made specifically against me.
Q I say that, doctor ---
A Dr Murch was charged with answering the question about ethical approval.
Q Never mind the specifics of who fulfilled what role, doctor; I will come on to that. What I am asking you now is that you were being asked to consider the whole issue of, amongst other things, ethical approval; the whole collective complaint, if you like, in circumstances where the paper had been the subject of intense scrutiny and where serious suggestions were being made as to the conduct of all of you, collectively. That is the point I am trying to elicit.
A The paper had been the subject of scrutiny by others. We had not at that stage had an opportunity to scrutinise it in detail ourselves. As I say, we were charged, after the meeting with Dr Horton, with producing statements in a very short time frame, in the absence of any documentation at all – having just, in my case, returned from America – for a deadline of Friday.
Q In fact, looking at the issues collectively in relation to ethical approval – in other words, one of the serious complaints that you were having to deal with – it was not the first time that an issue had been raised about that, because I suggest that you must have known, at least in general terms, of the concerns raised by Professor Sir David Howell, which Dr Zuckerman had written to your head of department about.
A Those were readily dismissed because the tests were being conducted for clinical reasons and Professor Sir David Hull’s supposition that the children did not suffer long-term bowel disease was in fact mistaken.
Q I am sorry, I am not asking you to go into the merits, I am simply saying this was the second time that someone had raised queries about the whole situation in respect of ethical approval. As a matter of fact it was the second time.
A It is also a matter of fact that the issue raised by Sir David Hull was long off the radar and indeed was hardly ever on my radar since it was not a matter of concern.
Q I came back and you attended a meeting, we have heard, with Dr Horton and with Professor Walker-Smith, Professor Murch and Dr Harvey, is that correct?
A I believe there was at least one sub-editor of The Lancet there, yes.
Q At that meeting it is not correct to say that you had no documentation because Dr Horton had the 172-96 ethics committee application papers that had been given to him by Mr Deer, the investigative journalist?
A Did he? I have no memory of that at all, I am afraid.
Q So at that meeting you are saying Dr Horton did not indicate to you or did not discuss with you the papers that he had been given by the investigative journalist?
A No, he reported to us the charges or the allegations that had been made.
Q There was then some part of a day at the Royal Free where you did not attend, because of course by then you were no longer at the Royal Free, which took place with Dr Horton, Professor Humphrey Hodgson the then dean and the clinicians, and you were aware, were you, that that meeting was taking place?
A I was aware of the charges with which they were having to deal; I am not sure that I was aware of the specific circumstances of their meeting.
Q Although you were actually absent from that part of the meeting, at some point an arrangement was made as you have described to the Panel in relation to the roles that you should take, because there was a wide spectrum of complaints that had been made and you each dealt with a specific aspect, is that correct?
A That is correct.
Q I were aware, were you not, that some of the allegations were specific to you because they related to your role in the litigation but some of them related to all of you?
A Correct.
Q Were you aware that Professor Murch himself had been a member of the Royal Free ethics committee at the time of the 172-96 application?
A I believe I knew he was on the panel, yes.
Q Was he asked to deal with the ethics committee matters?
A Yes, he was.
Q By whom?
A I believe by Dr Horton.
Q And Professor Walker-Smith was asked to deal in broad terms with the referral aspects, is that correct, how the children came to be referred to his department?
A At least with that aspect, yes.
Q And you were asked to deal with the aspects in particular in relation to allegations as to your role in the litigation and how that may or may not have tied in.
A Correct.
Q Did the three of you communicate with each other prior to your statements being published in The Lancet? Perhaps that is not a very fair question because you may not know what communications took place. Did you communicate with either of the other two clinicians prior to the statements appearing in The Lancet?
A I simply cannot remember.
Q It is likely that you would have done, is it not, if only to make sure that you were all, in a responsible way, happy with what the others were saying?
A It is quite possible that we did not, only in light of the nature of the allegations that had been made and the strong feelings at that time about the roles of various people in the matters and also the extraordinarily abbreviated timeframe in which our answers had to be put together and submitted to The Lancet.
MS SMITH: I am going to be reverting at a later stage, Dr Wakefield, to your statement in The Lancet because you appreciate at present I am only discussing with you whether 172-96 and The Lancet were one and the same, so on that basis I want to go if we may to a matter which you have indeed anticipated which is what Professor Murch said about the ethics committee approval in The Lancet.
If you go to I3 at 1212, please. This is a long statement and it is a very long time since we have referred to it. I wonder whether it might be appropriate for members of the Panel, rather than me reading it out again, for both Dr Wakefield and members of the Panel to have five minutes to read through and remind themselves of what it says.
THE CHAIRMAN: Yes, indeed, thank you. (Pause for reading). The Panel have finished reading.
MS SMITH: I think you will accept, Dr Wakefield, that that is a very detailed journey through all the relevant permissions in relation to ethics committee approval 172-96.
A It is Professor Murch’s statement and it is based upon his recollection at the time. It is not mine and I cannot say further than that, I cannot add to it.
Q Presumably when you saw it you agreed with it.
A As I have said, my memory of events is based – or my recollections have been based where possible upon the published documents and this formed one of the published documents. It was something upon which I have relied since that time until further documents came into evidence.
Q Did you see it before it was published or did you only see it when it was published?
A I cannot remember; all I know is that we had very little time and we were preoccupied with our own role in this, answering our own specific questions. It may well be that I did not see it.
Q At any rate you accept that you would have seen it when it was published in The Lancet.
A Yes.
Q Presumably when you saw it – I am not talking about now, I am talking about then, when it was published in The Lancet in 2004 – you agreed with it.
A I have to say it was impossible to know quite what I agreed with at the time. It is something of an understatement to say that my life was thrown into complete disarray and it was a very disorienting time. I really can give you very little insight into what my precise thoughts were following this issue.
Q It was a public statement, Dr Wakefield, made in effect on behalf of all three of you, as everybody’s statements were, in The Lancet in the face of allegations of serious scientific misconduct; that is correct, is it not?
A It was Dr Murch’s statement.
Q Dr Wakefield, I am going to pursue that with you because I started these questions by asking you whether it was not correct that there were overarching allegations in respect of all three of you and in addition to those there were allegations in respect of you individually in relation to your involvement in the litigation, and you agreed that that was the case.
A That is correct.
Q So the allegations relating to research misconduct as a result of not having the appropriate approvals applied just as much to you as they did to Professor Walker-Smith and Professor Murch.
A That is correct.
Q So when you keep saying this was Professor Murch’s statement, it may have been Professor Murch’s statement and I am perfectly prepared to accept that it was, but it was a statement which was made on behalf of all of you, is that not correct?
A No, it was a statement made by Dr Murch about the specific aspects of the allegations that he was asked to deal with.
Q Allegations relating to research misconduct in not having the appropriate research ethics committee approvals, which applied to all of you.
A Correct.
Q So that the answer was on behalf of all of you. I do not say anything about ethical committee approvals, do you, so if what you are saying is correct you never responded to these serious allegations.
A No, not at this stage, I made no response. The response came from Professor Murch.
Q Exactly, which is the point that I am putting to you, although it is taking us rather a long time. Professor Murch was answering both on behalf of himself and you too, just as you were all answering on behalf of each other. I answered the allegations in relation to the litigation and Professor Walker-Smith answered the allegations in relation to impropriety in the referral process.
A I was dealing specifically with allegations in relation to me, not on behalf of the other two.
Q No, because they did not apply to them.
A But you just suggested that I did.
Q I am sorry. I cannot think that there is any disagreement between us. When Professor Murch wrote this statement about ethical practices committee approval of The Lancet children, are you saying that he wrote that only on behalf of himself, or are you saying that he was explaining in The Lancet the position in respect of all of you.
A He was explaining in his terms the position in respect of what happened.
Q So we can assume, can we not, that you agreed with it?
A No, we cannot.
Q Are you saying you disagreed with it?
A What I am saying, Ms Smith, and to the Panel is that at the time I cannot remember what I agreed with or disagreed with other than the contents of my own statement. Please bear in mind that on the Sunday of that week there was an article in The Sunday Times followed by – no, even before that Richard Horton went onto national media denouncing me and expanding upon the allegations that had been made and his interpretation of them. Then there was the article in The Sunday Times on the Sunday and then there was the appearance of a large number of reporters on my doorstep, and my life from that point on was chaos. What I am trying to say is that I do not remember and I am not prepared to speculate on what I remembered or did not remember around that time. It is only subsequently, as documents have come into my possession, that I have been able to piece this together.
Q Doctor, I think we all understand that this was a very, very worrying time for you since, as I say, you had just had allegations of serious scientific misconduct made against you, but this was a statement that was made in March 2004 to The Lancet and published, and you have known since March 2004 that that was the position as far as the scientific community was concerned, that is what they were told, what was published in The Lancet by the three of you, and it has stood uncorrected since 2004. That is a fact, is it not?
A Until now there was not the opportunity to correct it.
Q Why did you not write to The Lancet and say “We realise that we made a mistake when we said all this and in fact the ethics committee approval 172-96 was nothing to do with The Lancet children” – if that was the case?
A I have had very few dealings with The Lancet in relationship to this matter since that time.
Q I have to suggest to you that the only reason that you now say that these children were not seen under the auspices of 172/96 is because that statement has resulted in these I proceedings against you.
A No, Ms Smith, the reason that I say it is based upon the full, contemporaneous documentation that has now come into play, and is the final piece of the jigsaw that was missing that allows me now, based upon the documents, not upon memory but upon documents, to reconstruct my state of mind at the time and what the Panel, I believe, if I am correct, is concerned with is what my state of mind was at the time. The letter to Dr Pegg and the documents that were submitted by Professor Walker-Smith have clarified what my statement of mind was. That is what I base my position on.
Q I see, The Lancet on your present case was completely misled by the information that was given by Professor Murch in relation to the ethics committee situation at the time, were they not? It is wrong, is what you are saying. I explained to us it was done in stressful circumstances but the fact is, it is wrong?
A Again, Professor Murch will answer to this issue, but the circumstances were more than stressful. The time frame for the construction of these responses was remarkably short; the documentation that was available certainly to me was virtually nil and therefore it was based upon memory. The fact that there are errors is quite understandable.
Q I see you disclosed to us a document, Dr Wakefield, which I am reminded of, and I would like you now to look at that. It relates apparently to some interchange between you and your co-authors prior to your statements being made. As I say, I would like you now to deal with that please. We have just received copies for everyone. Perhaps they could be passed round. This is a document, Dr Wakefield, that you disclosed at the beginning of the proceedings, just so you know what it is. It is going to go in I3. I am told it should go in your bundle at 1204a. (Document circulated)
THE CHAIRMAN: We do not have any document between 1202 and 1207.
MS SMITH: I do apologise, sir. In fact you do have a gap there, but the number was wrong anyway. It is 1202a. Just so we know about this, this is an email which was sent by Professor Walker-Smith to both you and Professor Murch.
“Dear Simon and Andy,
It was a difficult but useful meeting today.
I have been asked to write something about referral for our combined statement to The Lancet. I may well think it rather inadequate but it is attached. Have you Andy the exact dates in 1995 and 1997 when we began and ended?
Simon can you add the numbers we had investigated by your Lancet letter. Andy [do] you think we should quote the number from the JAMA paper?
Simon, I believe you will answer in detail the charge of deception in relation to the Ethical Committee the most serious charge of all and indeed for us all.
Andy you will deal with the legal issues.”
Then in fairness to Professor Murch I should just read the next paragraph:
“As for me in relation to legal issues I knew that individual children were being referred to the lawyers. I was quite unaware that a case action was underway in the period 1995-1998. I don’t think I even knew what the term meant at that time. I only learned today that 4 or 5 children in the 1998 paper were part of that class action although I knew that [Child 2] and some others were. It would have been wiser in retrospect as Richard [that is Dr Horton] said to have indicated this back in 1998. It is easy to be wise after the event.”
The rest of it deals with these observations and personal matters into his availability. I am not asking you at the moment, Dr Wakefield, about Professor Walker-Smith’s position on the legal issues, but it would appear, would it not – and I am not suggesting there is any reason why you should particularly remember this – that there was communication between the three of you in relation to the statements which were subsequently put into The Lancet paper.
A Yes, it clarifies the issue, exemplifies how imperfect the memory is.
Q And it refers in particular to the fact that what you all envisaged was a combined response to The Lancet?
A What it seems to do is separate things that we will respond to.
Q
“I have been asked to write something about referral for our combined statement to The Lancet.”
Then you deal with your respective roles. I are aware that it was being seen as a collective position?
A I am not sure. All I can say is that the ultimate statements were separate. There was no joint authorship. It was a statement by Dr Andrew Wakefield, a statement by Dr Simon Murch, etc.
Q And we see there a particular reference by Professor Walker-Smith, asking Professor Murch to deal in detail with the charge of deception in relation to the ethics committee, and he says this was “the most serious charge of all and indeed for us all.” So you were aware in broad terms of the importance of the issues relating to the ethics committee and whether or not they were apprised of the research on these children?
A Yes, I was.
Q I see, what Professor Murch in fact said in the statement in The Lancet which you accept has gone unchallenged since 2004, anyway so far as the details of the ethics committee approval, was indeed correct, was it not?
A No, it was not. Again, Professor Murch will discuss his position on this, but the correct position has been made clear by the introduction of documents, as I have explained before, which reflected my state of mind not in 2004, not when these statements were put together, not with the problem of hindsight and memory, but upon the documentary evidence that has been available to me since that time, right up to the beginning of this hearing. That documentary evidence is self-explanatory.
Q I see, if we look at page 1215, please, again at the time, March 2004 and the same issue in The Lancet, a statement from the Dean of the medical school. I am not going to read it all out, but I want to look at the start of it.
“We are entirely satisfied that the investigations performed on the children reported in The Lancet paper had been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behaviour and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practice Committee at the Royal Free Hampstead in 1996.”
He then underlines the fact that the Committee is independent of the hospital. That can only be, again, a reference to 172/96, can it not?
A That is what it appears to be.
Q Yes.
A Clearly I cannot say what documents were available to Professor Hodgson when he made this statement.
Q If we stay in the same bundle and go to 1211, that is the actual statement by the editors of The Lancet, we see the allegations on the left hand side, and I am only looking at the first one.
“(1) That, contrary to a statement in The Lancet paper, ethics approval for the investigations conducted on the children reported in the study, some of them highly invasive (eg, lumbar puncture) had not been given.”
And we see the conclusions of The Lancet editor on the right hand side.
“Allegation 1
The evidence we have seen indicates that ethics committee approval was given for data collection from clinically indicated investigations in the children with an initially undiagnosed illness and who were described in the 1998 Lancet paper:”
That information, obviously Dr Horton’s information, will have come from the authors. Is that correct?
A I am not sure where this specific information came from. It did not come from me.
Q Dr Horton is not going to know anything about the Ethical Practices Committee at the Royal Free Hospital except what he is told by the Dean and the authors of the paper, is he?
A I imagine he has met with Professor Hodgson by this stage, I believe, and he has met with them. I really cannot comment since I was not at these meetings and these are not my documents.
Q According to you, doctor, they are all wrong, and you have now come up with a totally different account when you are answering the charges that have been brought by the General Medical Council?
A What I am saying is that there were errors which are understandable in light of the time. That is a factor that has affected everybody during the course of this hearing. The absence of documentation, particularly as I had no documentation to this effect. I did not even have the letter which was sent to Professor Walker-Smith in my files at home, which revised the approval date to December 18. All I had was the original letter, giving approval some time earlier and that was a source of clear confusion to me. The letter from Maureen Carroll – I do not remember the number of that letter – but giving approval some time earlier. It was an error on the part of the ethics committee, and I accept that, but there was an understandable difficulty in reconciling the events given the time frame, the interval, and the absence of the appropriate documents. So in relying on what documents were available to me, I was forced to reconstruct the events or attempt to reconstruct the events, and there is an inherent danger in that. When the documents were finally complete, as they are now, then the events and my state of mind have become much clearer.
Q And no attempt has been made since March 2004 to put right what you say – I mean as far as The Lancet is concerned – is completely wrong. Wrong by Professor Murch, wrong by the Dean, by the editor of The Lancet. All wrong as far as ethics committee approval is concerned. Is that right?
A I think we will have to wait what the other defendants say in their evidence, but the answer is no. From my perspective, I pursued several avenues in an effort to reconcile this and put it right. One, in a passive sense, having been brought before the General Medical Council but the other, in an effort to litigate against those who put forward the allegations in the first place, in order to reconcile what was happening. Again, those efforts at litigation on my part were constrained by a lack of documents, which have now clarified the situation.
Q I am sorry ---
A There has been an earnest effort on my part to try and correct the situation, the broad situation, that was created by these allegations in the first place.
Q Dr Wakefield, I know what you are talking about, but I think it is highly unlikely the Panel do, so when you refer to litigation you mean you sued Channel 4 and the investigative journalists for defamation?
A That is correct, yes.
Q And you threatened Dr Horton with defamation proceedings as well, as he told us?
A I sought an apology from Dr Horton.
Q So that is what you are saying you did as an attempt to understand the precise ethical framework in relation to the investigations on these children. That is what you are saying you were doing to try and find out what happened, and put it right? Are you really saying that, doctor?
A What I have realised is that articulating, or seeking to articulate arguments in the absence of the documentation was fraught with hazard. The original allegations created the impression that they had been formulated on a proportion of the documents in the absence of the rest, the rest merely constructed. There is a huge danger in doing that and I was not prepared to go on record or to try and set the record straight in the absence of as much documentation, and the absence of as full a comprehension as what had actually happened as I could because that was only going to lead to further confusion, erroneous conclusions and ultimately the wrong answer. So what I have tried to do is be patient, to put the documents together, to assimilate them into a chronology and determine what actually happened and when it happened.
Q And you are telling the Panel that that was your motive for defamation litigation. Is that correct?
A That was not my motive. It was my modus operandi. What I was trying to do is bring the elements together to correct what I perceived to be the wrong that had been put out there into the public arena.
Q I think just so that we are all clear, that litigation has been discontinued by you. Is that correct?
A That is correct, yes.
Q I want to turn just to one last matter in relation to this same issue, which has been the evidence that you have given over the last few days to the Panel, Dr Wakefield. I have said in your evidence, and I am at Day 48/48 – and I am very happy that you should have it in front of you if you would rather look at it than have me read it. I think it might be more suitable if you did. It is Day 48/48F. (Document handed to the witness) I hope that at letter F – because I am looking at an extract removed from the transcript – you will find an answer by you, which says,
“It may be an appropriate time and it may help the Committee just to say that the allegations against my colleagues and against me have laboured for many months now under the misapprehension….”
Are you with me?
THE CHAIRMAN: I am sorry, did you say ---
MS SMITH: Day 48/48 at letter E.
A Yes, I have it.
Q I am not going to read it all out; it was just that I thought you might wish to have it in front of you. However, you say in that, halfway down,
“One was a preliminary clinical investigation with research elements, conducted under an existing ethical approval from Professor Walker-Smith, and the other was a research application. It is the erroneous confluence of those two elements that has led to a great deal of confusion. To some extent that is understandable and it has only been resolved, certainly in my mind, by the introduction of documents by Professor Walker-Smith and his team during the early part of the last session….”
Then you go on to underline the fact that 172-96 and The Lancet were not the same. Are you telling us that it was not until this hearing started that you knew what ethical committee approval you were acting under at the time?
A No. I was guided in the construction of my evidence initially by the documents available to me and they were limited, and they included Professor Murch’s statement to The Lancet. Even though that was somewhat difficult to reconcile in time frame, that is all I had.
Q I am sorry, but you say in the part that I have just read to you that it had only been resolved in your mind by “the introduction of documents by Professor Walker Smith and his team during the early part of the last session”. In other words, the last session, as I understand you meant, in the I.
A Yes, there was a complex jigsaw of the events of 1996 onwards from which a piece was missing, and that piece was essential to reconstructing what was my state of mind. The documents that were introduced, in particular my letter to Dr Pegg, clarified what was precisely my state of mind; that is, that there was a pilot study and then there was 172-96.
Q We have been to that letter and we have discussed it at length, doctor, and I am not going to go back to it; but what I am going to ask you is this. Are you saying that you were not aware of the nature of the ethical committee approval under which you were operating when you were involved with these children until Professor Walker-Smith produced the documents at the last hearing?
A I am sorry, I understand. No, I was aware of that throughout and I was aware of it from the time that Professor Walker-Smith arrived at the Royal Free. We discussed it and, as I say, it was considered at the time a very proactive approach. Certainly I had been working on tissues from inflammatory bowel disease for many years and I did not have such an approval; so, no, I was aware of it throughout.
Q I have already dealt with your position when enquiries were made by Professor Hull in 1998 and with your position as reflected in Professor Murch’s statement in The Lancet in 2004; but since then, and prior to the beginning of these proceedings, you had had access to all the medical records relating to these children, had you not?
A Yes, I had as part of these proceedings, albeit that some were incomplete.
Q Doctor, you had had them in relation to the litigation, had you not?
A In relation to the litigation I had had specifically Child 2 and Child 5.
Q I provided the General Medical Council with the medical records of these children, doctor – I mean your lawyers on your behalf. Where did they come from?
A Were they provided by me? They may have come as part of the defamation proceedings, but….
Q Yes, they were in fact provided by your lawyers. As I say, I am not making a considerable issue over this; I am just trying to ascertain when you would have had access to all these children’s medical records. I have had them for a considerable period of time prior to the onset of the General Medical Council proceedings.
A That is correct, yes.
Q I do not have to look very far in them to find the standard consent forms on which you now rely as being the consent under which you were operating.
A That is correct. The other document that I had, clearly, was Dr Murch’s statement.
Q What are you saying? That Dr Murch led you astray as well?
A Not at all. He, Dr Murch, in an honest attempt to reconstruct the events of what happened some years before, in an abbreviated time frame, I believe made an error of fact; but he will be able to talk to that.
Q I would have been aware of the consent forms in relation to the extra biopsies – Professor Walker-Smith’s earlier approval – and you would also have been aware that there were no consent forms for 172-96.
A Which reconciled in my mind, having read them, that these children were not investigated under 172-96; but I was not at that stage reflecting further upon the dissociation between that and Dr Murch’s statement in The Lancet.
Q But why did it take you so long to marry up your research in 1996 with the early permissions that were present in the notes – if that is truly what permission you were operating under?
A What I was trying to say is that there was some confusion; what I was trying to do was reconcile them. The last piece of the jigsaw that resolved that confusion and gave me insight into what my state of mind was was the document that was introduced by Professor Walker-Smith at the beginning of the last session.
Q I have denied that these children were seen under the auspices of 172 96, despite the statements that are made in The Lancet by the dean and Professor Murch, but it would appear to be the case that you are saying that you were not clear about the actual ethical basis for the research project until this hearing started.
A I did not return in detail to those statements in The Lancet made by the others. I was concerned with the statements that I had made. They were the ones for which I was going to be answerable, in my opinion.
Q I want to go on to another aspect, also connected with whether these Lancet children were 172-96.
THE LEGAL ASSESSOR: I wonder if I could interrupt, Ms Smith. There is something that was left hanging in the air rather a long time ago. It is now going to look rather out of place, but I think that it should be dealt with one way or the other, or at least recorded on the transcript. When you were questioning Dr Wakefield about The Lancet editor’s statement at page 1211 of I3, you were specifically asking him about the editor’s responses to the allegations. He was then saying something about meetings with Professor Hodgson which he was not party to, resulting in what the editor said. That rather petered out as a line, but I think that people’s attention should be drawn to what is said at the bottom of the first column on page 1211 – and Dr Wakefield can obviously comment now, or Mr Coonan can deal with it in re examination if he wishes to. It says there,
“With this notice are accompanying statements from Dr Murch, Professor Walker Smith, and Dr Wakefield, answering allegations of research and publication misconduct, together with a statement from the Royal Free and University College Medical School.
Given that these four statements, together with an evaluation of the available documents, we consider that….”
So it is made clear that they are saying they base their comments on the allegations on the statements that were also published.
MS SMITH: Absolutely. Thank you very much. Indeed, I see I have a note and, as you say, I petered out somewhat on that point. (To the witness) Dr Wakefield, perhaps I can say that that does confirm indeed, does it not, that the information that was being acted upon by The Lancet resulted from what you, the co-authors, had told them and their inspection of the documents that were available to them?
A That is correct.
Q I want to take you on – and it is opportune – to another aspect of The Lancet paper in relation to the same issue. Before I do so, I want to be absolutely clear. If we are just looking at The Lancet for a moment, the children who were in The Lancet study, as I understand it, what you are saying you did in relation to them was play a role in the histopathological review. Is that correct?
A Yes, on a regular basis, around a multi-headed microscope, I would sit with Dr Dhillon and Dr Anthony, and Dr Dhillon would take us through the pathological changes that were present or absent in those children.
Q I said that that review was undertaken on the basis of an analysis which was designed and carried out by Professor Dhillon and Dr Anthony.
A Yes, the document, or pro forma document, which was used to evaluate the biopsies was designed by Dr Dhillon, and the detailed analysis and the ultimate conclusions from that were based upon Dr Dhillon’s opinion.
Q I, you have told us – and this is day 49/8 if anyone wishes to look at it – were “looking over their shoulders to learn”. Is that correct?
A That is correct. I was there in a learning capacity and it is true, as I have said in The Lancet, that they were reviewed by Dhillon, Anthony and Wakefield – or words to that effect.
Q If we look at I2, 787, at The Lancet paper, and if we look down at the bottom under “Contributors”, we see Dr Wakefield “was the senior scientific investigator”. If we go back to page 783, where the co-authors are set out at the top of the page, you are the first author.
A Correct.
Q A “senior scientific investigator” is how you describe yourself, or “scientific investigator”, in the ethics committee application 172-96, is it not? I were the scientific investigator under that protocol.
A That is correct.
Q Upon what possible basis do you – if indeed, which I suggest to you is not the case, your only role in The Lancet paper was to stand at the shoulders of Professor Dhillon and Dr Anthony and learn about histopathology – upon what possible basis do you become senior scientific investigator and first name on the paper?
A Really, in a nutshell, because I was the coordinating investigator and I took the initiative to write the paper; to pull the evidence together from my clinical colleagues and others; and to articulate a discussion, which generated hypotheses based upon that data. That was the basis upon which I was designated senior scientific investigator.
Q So you are saying that your role in these children’s investigations merited that description, are you? That that was appropriate? That you should be first author on the paper and that you should be named as senior scientific investigator was appropriate, on the basis of what you did?
A Yes.
Q I think that we are probably not arguing about that, Dr Wakefield, because I suggest to you that what you in fact did in relation to this paper was fulfil the role that you carefully set out in your application 172-96, namely as the scientific investigator, and that your status in this paper reflects what I have suggested to you before, namely that your research hypothesis drove this entire study.
A No. The study, as I have said before, was initiated by parental request for an investigation of their children, who were symptomatic, had chronic unresolved gastrointestinal and neurological symptoms, and they sought clinical investigation. That, as I have said – and I am happy to go on saying – was the absolute priority. Without that, there would have been no study; there would have been no investigation at all. That is what motivated the team at all stages. The scientific aspects, although important, were subsidiary to that.
Q Does not that description, Dr Wakefield, make it overwhelmingly the case – I mean that description of your role – that The Lancet children were in fact Project 172 96?
A Irrespective of the title which is appropriate, the clear evidence that these children were not 172-96 were the communications between the members of this collaborative team and Dr Pegg, which set out clearly not only the clinical indications for seeing these children but also the state and stage at which children had been seen, how many had been seen, and what the findings were, in advance of 172-96 going ahead, and subsequently the modification of that protocol.
Q Whilst we are on the subject of links between the studies, Dr Wakefield, I have touched on before, and I will come back to it when we look at the litigation – the links between 172-96 and the Legal Aid Board study on the new syndrome and The Lancet – you accept, as indeed you told Dr Horton at the time, that there was an overlap between the children in The Lancet paper and the LAB study.
A That is correct, yes.
Q Indeed, despite your extreme state of anxiety and confusion, you were able to tell Dr Horton that it was four or five children, and that is your position today.
A That is correct, yes.
Q We know from the correspondence that the Legal Aid Board study on the syndrome was the clinical and scientific protocol which was to become Project 172 96.
A No, that is an error and I have tried to point that out. That was a document submitted in draft form by Richard Barr to the Legal Aid Board. The clinical and scientific protocol was the protocol and costings document which was sent to the Legal Aid Board.
Q Yes, but you accept that there was an overlap, as you have told us, and you accept that 172-96 was the approval under which you did the Legal Aid Board study.
A That is correct.
Q So, at least as far as those children are concerned – the children in the overlap – they were part of Project 172-96, because you say that was the approval under which you did it, part of the Legal Aid Board study, and their cases were written up in The Lancet.
A Their cases were written up in The Lancet and their histological findings were written up in The Lancet. Their viral analyses of tissues were not written up in The Lancet and those viral analyses which formed part of the Legal Aid Board study were written up as an entirely
separate study, acknowledging the Legal Aid Board contribution – a paper which has yet to be published.
Q If you say you believed you were acting under the 172-96 approval when you were doing the Legal Aid Board studies – you said the ethics approval for the Legal Aid Board studies was subsumed under 172-96 – then where are the 172-96 consent forms in respect of the Legal Aid Board children?
A This is an issue that is slightly complex; in other words there were biopsies that were taken from those children that formed part of the overlap between The Lancet 12 and the Legal Aid Board study. Those biopsies were taken under 162-95; in other words there was ethical approval for them. This is the issue that came up earlier, which approval covered which. Latterly it is my opinion that it was 172-96 that operated but the early biopsies clearly were taken under 162-95. I accept that that is confusing, but the important point is that biopsies were only investigated in a scientific manner under ethical approval. That is the key.
MS SMITH: Sir, I see it is five to one and I am going to turn on to a completely new topic so if the Panel were agreeable this would be the moment to stop rather than me to start for a few minutes.
THE CHAIRMAN: I am sure that is right. It is now five to one and we will now adjourn for lunch and resume at five to two. Dr Wakefield, just to remind you once again that you are still under oath.
(The luncheon adjournment)
THE CHAIRMAN: Good afternoon. Ms Smith.
MS SMITH: Thank you, Sir, and thank you very much for allowing us a few more moments. Dr Wakefield, before I leave the subject of the ethical approval for The Lancet study I want to ask you, if you would, just to revert quickly to FTP1, page 366aa. Dr Wakefield, as I understood your evidence this morning you place great reliance on the knowledge that you gained from this document.
A It is certainly a very important document, yes.
Q You told us that the production of that letter by Professor Walker-Smith in the course of the GMC hearing on the last session allowed you for the first time to piece together the ethical basis for the investigation of The Lancet children.
A It clarified for me my state of mind at the time.
Q In fact, I have to suggest to you, Doctor, that you had had that letter in your possession certainly since March of 2006.
A I do not remember it and I certainly did not remember it until it came into evidence.
Q I would like you to look if you would at a document, and you had better have it in front of you before I ask you questions about it. It is to go into the bundle between pages 1222a and 1222d in FTP3. (Document distributed). Dr Wakefield, this is a standard disclosure list in the defamation proceedings which you referred to this morning and which took place between you and the parties that we can see at the top under “Defendants” – Channel 4 in particular, a television production company and Mr Deer the investigative journalist. I know that you will understand this, but just so that the Panel know, any party to civil proceedings is asked to produce a list of documents that they have in their possession which are relevant to those proceedings. Is that document signed by you at page 1222b; is that your signature at the bottom of the page?
A Yes, it is.
Q That is 15 March 2006 and if we go on to 1222c we see that you stated in the standard way that you have got control of the documents numbered and listed and we see, “see Appendix 1”. Page d is simply an extract from a long list of documents and at the top of the page under the initials AWE, number 67, “Letter A Wakefield to Dr M Pegg dated 3 February 1997”.
A Correct.
Q That is in fact the letter at 366aa of the FTP bundle, is it not?
A It is.
Q Just so that everybody is clear, although you apparently had this document from an early stage it was not produced to the General Medical Council until the onset of these proceedings in July 2007, but what I want you to explain is why it is that you were suggesting to the Panel that you were not able to explain in your own mind, let alone anybody else’s, the ethical framework in relation to The Lancet children until Professor Walker-Smith produced this document in these proceedings, because in fact it is clear, is it not, that you knew all about it, and indeed it is one of your own list of documents in March 2006?
A Well, I think this goes clearly to the issue of how poorly memory has served these proceedings, Ms Smith. I think that had I seen this document earlier and remembered it then it would have cleared up this issue in my mind much earlier. What it does not do in any way is alter the content of the letter and the meaning of the letter is absolutely clear. It refers in the first paragraph to 172-96 and it refers in the second paragraph to the pilot study that precedes 172-96, so albeit that I may have forgotten that this document amongst the many, many thousands of documents existed, if I had remembered it earlier I would most certainly have produced it and used it by way of explanation.
Q We know what you say the letter said, Dr Wakefield, and that is not what I am asking you about and I think you appreciate that. You have told the Panel that the reason that you have given a completely different account of the ethical committee approval from that that was given in The Lancet back in 2004 was because you had not, in your own mind, worked out what ethical approvals you were acting under. You place reliance on that letter and we now know, do we not, that you are quite incorrect in saying that you did not have access to that letter in the very proceedings which you were telling the Panel before lunch you had brought, amongst other things, for the purpose of sorting out in your own mind the documents?
A That was my honest memory; it does not alter the content of the letter one iota. As I say, if this letter had come to mind it would have resolved this issue for me somewhat earlier.
Q I have to suggest to you, Dr Wakefield, that this elaborate explanation of the ethical approvals that you were acting under at that time, which you say – and indeed it is the case – are at total variance with what Professor Murch was saying when the enquiry was made has been something that you have evolved as a way to explain what is otherwise misconduct in relation to the ethical approvals on this study.
A I would suggest to the Panel that Ms Smith’s interpretation is entirely illogical and fails to take into account the series of letters and exchanges between Professor Walker-Smith and Dr Pegg, myself and Dr Pegg, which make clear to Dr Pegg in advance of his date of 18 December that there is indeed a study under way, based upon clinical examination, that is identifying pathology in these children. That is clearly incompatible in any shape, manner or form with the idea that we were trying to operate this protocol, 172-96, on the original Lancet children.
Q I am going to turn on now, if I may, to another section which deals with several topics concerning your involvement in the MMR litigation and with the Legal Aid Board. There are a number of strands to this and naturally you can answer questions however you like, but I am going to deal first of all with the factual background of your involvement with Mr Barr and with Dawbarns before coming on to the Legal Aid Board study, and I am not proposing at this juncture to deal with the actual financial aspects which I will come on to. Dealing with it back to the start, we know from the start of 1996 onwards you have told us that you agreed to act as an expert in the MMR litigation.
A Correct.
Q As a result of that would it be fair to say that you were closely involved with those aspects of the litigation which you considered relevant to your role as an expert from then on?
A Yes.
Q The first paperwork that we have relating to the litigation we have referred to before and I am only going to look at it briefly now is at FTP1 at page 90, please. That is in February 1996 so a month or so after you think Mr Barr and Ms Limb came to see you in your office, is that correct?
A Sorry, which page?
Q Page 90, the Dawbarns newsletter of February 1996 – we see the date at the top of the next page, 91.
A Yes.
Q If we look at that document I have already dealt with and you have given me an answer to what Mr Barr says about your views on the vaccines and Crohn’s disease, which is on page 91, and also you have given us your answer in relation to his, you say, erroneous understanding of the tests that you wanted to carry out. The only thing in addition that I would like to ask you is the next heading down under your own heading, “Dr Reed Warren”. I think you were well aware of Dr Warren’s views about vaccines and autism at that time, is that correct?
A I had read some of his work in relation to this matter and I believe I had heard him lecture on one occasion.
Q Indeed, you quote him in the clinical and sciehtific protocol.
A In the context of complement metabolism, yes.
Q We see that under Dr Warren, Mr Barr says,
“A disturbingly high proportion of our cases involve childhood autism. These apply generally to the MMR vaccines (as opposed to the MR vaccines). Dr Reed Warren of Utah in the USA is developing tests to try to find a link between the vaccines and autism and his work has already been widely published in the US. He is anxious to set up a testing scheme for English children.”
Can you assist us at all as to that, was that something that you discussed with him?
A No, I have no knowledge of that.
Q From that time onwards, February 1996, doctor, we see at page 91 that Mr Barr has listed the symptoms at the top of the page that parents are to look for, ands you have told us that you did not have an input into those symptoms, but he has also said to parents “could you please contact us and it may be appropriate to put you in touch with Dr Wakefield”.
As far as that is concerned did the solicitors make you aware of the fact that in some way they were proposing to put parents who came to them in touch with you?
A I am afraid I cannot remember the discussions that we had at the time or how it came to be presented in this form since I have not seen this or have no memory of receiving this document.
Q But I am asking you whether when these parents – you have described the process of them coming to seek your assistance and we can see from that, whether you knew about it or not, that Mr Barr was telling parents that if they got in touch with him it might be appropriate to put them in touch with you, so what I am asking you is when these parents contacted you were you aware of some sort of arrangement that the solicitor had made in relation to that?
A No, I am sure I was not.
Q You mean the parents, when they rang you up, never said “Mr Barr the solicitor has suggested that I contact you”?
A That is correct.
Q I am sorry, just so I am clear, you are saying it is correct that nobody ever mentioned any contact with Mr Barr.
A My memory specifically relates to the children seen early on because those are the ones where I have had to scrutinise the records and have reconciled how all of those parents made contact with me and none of them came through Mr Barr as far as I am aware.
Q If we turn on to page 101, please, this is a letter – and again I realise this is not a letter that you would have seen at the time – from Mr Barr to the Legal Aid Board, and we see in the middle of the page:
“There does at last seem to be an increasing acknowledgement among the medical profession that these vaccines actually are causing damage. Dr Wakefield (who has been mentioned to you in Counsel’s Opinion and by me several times) is actually quite astonished at the evidence that he is uncovering and feels that objective tests may well establish conclusively that the measles vaccine is causing a wide range of these injuries.”
Did that accord in broad terms at least with the views that you were expressing to Mr Barr at that time?
A Again, this is not my document, it is Mr Barr’s document, and I cannot speak to what he is talking about here. I have addressed this in direct evidence and at that time the evidence that I was uncovering was in relation to vaccine safety studies. That may be something to which Mr Barr is referring.
Q Would you have said that you were astonished at the evidence that you were uncovering in that respect?
A These are Mr Barr’s words, I simply cannot speak to Mr Barr’s opinion.
Q
“…feels that objective tests may well establish conclusively that the measles vaccine is causing a wide range of these injuries.”
In broad terms, Dr Wakefield, never mind how Mr Barr interprets it, from your point of view does that express your state of mind at that time, that you thought if some testing was done it may well be found that measles vaccine was causing a wide range of injuries?
A No, it does not. My interests were in a very narrow range of injuries.
Q He goes on:
“I am waiting for his protocol proposals but a significant part of the costing will be in a proposal for testing a selected number of children to try to establish the link.”
That could mean either that he is awaiting the costings on a protocol that he already had, or it could mean that he is awaiting the protocol itself, could it not?
A It could mean anything to that effect. I do not know.
Q If we go on, page 102, at the top of the page:
“… we are obviously still having to co-ordinate by dealing with enquiries, the media and so on. There are experts that we would like to continue to correspond with both in this country and in the USA and we would also like to start to see as many as we can in this country. We have already had several constructive meetings with Dr Wakefield but there are other experts that we would like to involve covering a variety of different fields.”
Were you aware, as would appear to be the case from that observation, that you were amongst the first of the experts that they had consulted?
A Yes, I think I was.
Q Is it correct to say that by that time – this is May 1996 – they had had several meetings with you?
A Yes. Between January and May 1996 we had had several meetings.
Q Then, can we go on please to the next document, which is at page 12. I am sorry – I actually wanted to ask you about both that and the document prior to it, which starts at page 104, which is the proposed clinical and scientific study. As I understand what you are saying, you are saying, firstly, you did not know that this document at 104, the clinical and scientific study, was submitted to the Legal Aid Board with the document at page 121?
A I have no memory of that, and it was not submitted to Mr Barr for that purpose.
Q We have discussed already when we went through the chronology at the beginning, and the Panel will have heard what you had to say about why you gave it to Mr Barr, but your position is that, for whatever reason you gave it to him, you were not intending him to send it on the Legal Aid Board?
A In principle, I have no problem with him sending it to the Legal Aid Board provided it is in context. It relates to the investigation of children with autism and therefore there is only in part an overlap with the Legal Aid Board protocol, which refers to both autism and children with Crohn's disease.
Q You are saying that what you refer to as the Legal Aid Board protocol was not the proposed clinical and scientific study. Is that correct?
A The title of the document that was, in my mind, the protocol was on 121, and it is entitled “Proposed Protocol and costing proposals for testing a selected number of MR and MMR vaccinated children.”
Q So you are saying that that document, at page 121 onwards is both the costings – which we will come back to, if we may, in a moment – and, you say, the protocol as far as the Legal Aid Board are concerned?
A Yes.
Q Could we look at please? It starts of:
“A protocol giving the detailed technical specification is attached.”
First of all, by use of the word “attached”, how can that mean, Dr Wakefield, that that document was the protocol itself?
A This is Mr Barr’s document, and Mr Barr was responsible for submitting this to the Legal Aid Board. I had no direct dealings with the Legal Aid Board. What he included in here were my costings.
Q Yes? So when ---
A So Mr Barr is the one to answer that question, not me.
Q Mr Barr submits this with a detailed technical specification attached, and you have told us that this costing proposal was also protocol. That is what you have told us?
A Yes. The protocol that Mr Barr attached deals only with the children with autism. That was not the Legal Aid Board pilot study. The Legal Aid Board pilot study was an examination of five children with autism and five children with Crohn's disease – a quite distinct condition.
Q Can we just deal with this first of all, Dr Wakefield. The “detailed technical specification attached” must mean the clinical and scientific protocol, must it not? It cannot mean that document. I am sorry – it cannot mean the document that starts on page 121?
A So Mr Barr is referring to the attached protocol.
Q Then you accept?
A Yes.
Q I think that you would also accept that as far as this document is concerned – and please take time to look at the rest of it – it does not include a detailed technical specification?
A That is correct.
Q If we go on down:
“It is hoped that using the testing protocol attached it will be possible to establish the causal link…” etc.
So that again is a reference you accept the clinical and scientific protocol?
A Yes.
Q And you say that you did not see the costing proposal in its final form. Is that correct?
A No. At some stage I must have seen it. The question is whether I saw it prior to its submission to the Legal Aid Board.
Q I am sorry. Did you say you must have seen it prior to its submission to the Legal Aid Board?
A No. No. The question is whether I saw it prior to its submission?
Q Yes.
A At some stage it must have been sent to me.
Q The question was not, actually, whether you saw it prior to its submission. What I said to you is did you at any stage see the costing proposal? Did you at any stage see it in its completed form?
A Yes.
Q When was that, doctor?
A I have no idea, I am afraid.
Q Can I just ask you to look forward to page 183? I am just diverging from the chronology for a moment just to deal with this issue, doctor, but you will see that is the Legal Aid Board authority to do contract work. It specifically refers in paragraph 2 to facilitating –
“… the setting up of the clinical and scientific study proposed by Dr Andrew Wakefield in respect of 10 assisted persons.”
Would you have seen that document?
A Again, I believe I was sent this authority to do contract work at some stage.
Q So you would have been aware from that that the solicitors had submitted to the Legal Aid Board your clinical and scientific study, because there is a specific reference to clinical and scientific study?
A No, not necessarily. That probably would not even have caught my attention.
MR COONAN: Could the rest of that passage be read out?
MS SMITH: I am sorry. Which passage? Oh yes. The only reason I did not do so was because I did not want to get embroiled at this stage in the finances, but if you wish me to do so:
“… in respect of 10 assisted persons at a maximum cost of £55,000 and to cover the work necessary by the solicitors in so doing at a maximum cost…”
And then the figure is redacted. Can we now revert to the question, which is, the “clinical and scientific study” is a clear reference, is it not? It is not a phrase that a lawyer would use unless they had seen it in your protocol – a clinical and scientific study?
A The question is whether that alerted me to the fact that Richard Barr had submitted the clinical and scientific study. No, it would not have done, particularly in light of the continuation of that paragraph which refers specifically to the ten assisted persons, that is the five with Crohn's disease and five with autism.
Q You see, doctor, you rely terribly heavily on the fact that you happen to also have been agreeing within the sum that you were being paid by the LAB to cover five children who had Crohn's disease, as well as the five who had autistic enteritis. But that does not mean that the clinical and scientific protocol in relation to autism and enteritis was not relevant, does it? It just means it was not relevant to five of them?
A It does not mean it was not relevant. It just means that the way it is described is inappropriate.
Q Could we go on to page 370a, please?
A I am afraid I do not have that document.
Q Do the Panel have 370a, which is a letter from Dr Wakefield to Mr Wilson?
THE CHAIRMAN: Yes, we do.
MS SMITH: Could someone make sure that Dr Wakefield has this, please. Could he have an unmarked one? (Document handed to the witness) Have you had time to read it?
A (Pause for reading) Yes.
Q Please do not worry for the moment. I promise you we can come back to it if you wish to do so, but do not worry about the financing and Dr Schepelmann at the moment. The point I am asking you about relates to whether the clinical and scientific study applied to the Legal Aid Board study. You say there that the Legal Aid funding was to investigate the new symptom, do you not? And that new symptom, I suggest to you, must be the enteritis autistic syndrome that you planned to investigate under the clinical and scientific protocol?
A No, I think that is reading far too much into this letter, which is sent to a finance officer. Making the distinction between the new syndrome and Crohn's disease is not something that I would have done in this letter.
Q This is a letter from you. What did you mean by “new syndrome” if you did not mean the autism syndrome?
A I may well have meant that. What I did not mean in this letter to exclude was Crohn's disease as part of the Legal Aid Board pilot study.
Q I was not suggesting that you did intend to do that, doctor. Would you turn on to FTP2, please, at page 401? This is a letter that you wrote in March 1997 to Professor Zuckerman, and we have been to it before. The part I want to ask you about is where it says:
“These conditions”
i.e. relating to the Legal Aid Board –
“were based upon the enclosed protocol which has been approved by the Ethics Committee of the Royal Free Hospital.”
You told us in evidence that you thought that you had sent to Professor Zuckerman the clinical and scientific protocol, plus what you described as the Legal Aid Board protocol.
A It is likely in the interests of clarity that Professor Zuckerman will have received all of the documents that I had in relation to this.
Q I have already asked you why Professor Zuckerman would have found it clear to have you referring to one protocol when you are now saying you enclosed both, but what I want to ask you now is you must be accepting that by this time you had seen the Legal Aid Board protocol – so by March 1997 you were well aware that the Legal Aid Board’s protocol linked the Legal Aid Board study with the clinical and scientific study?
A Linked, yes, because the Legal Aid Board study was at least in part subsumed under 172/96. So linked, yes.
Q Linked it in the sense of the costing proposal, if you want to go back to that, making it absolutely clear that the costings referred to were based on the clinical and scientific protocol?
A Yes. What I would not have done at that stage, everything having been gone through and approved, is to scrutinise the documents again. I would have had no reason to do that. In other words, I would have taken the document at face value. I would not have read what Mr Barr has put in or not. I would have just put them together and sent them off. I am afraid there is not the time, nor is it necessarily appropriate, to go back over documents that one has read before, or have been written by others.
Q That letter, at page 401, is a clear acknowledgement by you that these protocols are to all intents and purposes the same protocol?
A They are clearly not the same protocol. They are clearly not the same protocol. One is an examination of children with autism and the other is an examination of children with autism and Crohn's disease. What I am seeking to do is to reassure Professor Zuckerman that there is ethical approval and that this document, this study that is intended, has been scrutinised and deemed biologically plausible and of scientific merit. That is the purpose in my sending this letter to Professor Zuckerman – no more complicated than that.
Q Then back to a document which is becoming only too familiar to all of us at page 471, doctor. I know we have been to this before, but I only want to ask you in relation to one sentence in it, which is in the second paragraph.
“This money has been provided through Dawbarns Solicitors … for the express purpose of performing the study outlined in the enclosed protocol. This protocol, as you will see, has been approved and passed by the Ethics Committee of the Trust.”
So again that shows, I suggest, that you knew that the Legal Aid Board had funded the 172/96 protocol, in other words, the longer document, the whole clinical and scientific study, not just the costings proposals?
A Again, there is a great danger in reading too much into this, because this was again to a finance officer in an effort to persuade, or at least communicate to him that the work that was being done had been scrutinised and considered meritorious, and had got ethical approval. It is quite different…. Perhaps I will leave it there.
Q Reverting to the chronology, please – which means going back to FTP1 and the costing proposals at page 121 – I am going back to this document, doctor, in relation to the actual sums of money, but as far as the objective is concerned ---
A I am sorry, which page?
Q Page 121. I understand that this document is written by Mr Barr but I am not asking you about the actual nature of the language. As far as the “Objective”,
“…to seek evidence which will be acceptable in a court of law of the causative connection between either the mumps, measles and rubella vaccine or the measles/rubella vaccine and certain conditions which have been reported…”
that in broad terms was the same purpose, albeit in your field, scientific rather than legal, as was to be tested by the clinical and scientific study, namely the association between conditions which arose in children who had had these vaccines.
A It was a very specific element of it. That approach – detection of the virus in diseased tissues – had been one that my group had adopted for many years, in the analysis, for example, of Crohn’s disease and ulcerative colitis. The intention – to apply that to the analysis of tissues in these children – was discussed and put into draft form in late 1995, at least by me. Part of that protocol, the viral detection, is contained within this document; and that was the principal aim of the Legal Aid Board pilot study.
Q Going on with the chronology, can you turn on, please, to 152? This is a document which you state in your evidence – at day 52/50 – was not for Dawbarns, the solicitors, but you provided to them. Is that correct?
A It is my understanding that, beyond the time that we made a link between vaccines and inflammatory bowel disease, there were a number of enquiries and a document was produced by way of information to parents and this, I believe, was that document.
Q Just in passing, doctor, but by reference to some questions I have asked you earlier, we see at the bottom of the page,
“Although no studies have formally examined the issue, we have been aware of a large number of new cases of childhood IBD following the MR revaccination campaign in November 1994”.
So there you were differentiating, were you not, between MMR and MR?
A Yes, on that occasion, and the reason for doing this is that we had, as I mentioned, sought to – I had sought to – prevail upon, or at least attempt to get some follow-up of the MR campaign in relation to the frequency or the change in frequency of inflammatory bowel disease. What I was trying to do was capture information on that and people would therefore, hopefully, make contact with me so that I was able to at least document such cases.
Q You sent this document to the solicitors, or gave it to the solicitors, aware presumably that they would hand it on to their clients.
A That was within their remit, certainly.
Q It was obviously what they were going to do, was it not, Dr Wakefield?
A And that is perfectly acceptable.
Q If we go on to page 153, under “What should we do?” –
“If you suspect your child has (IBD), prompt referral to a specialist centre is essential. Either the diagnosis will be excluded and your mind put at rest, or it will be confirmed and the appropriate treatment instituted. As a first step you should contact Dr Andrew Wakefield at the Royal Free Hospital”.
You have told us, Dr Wakefield, that confusions were arising because general practitioners misunderstood the nature of the referral, and indeed you have told us that you had to devise a special document, which we saw in the JS records, to deal with that situation, expressly telling people to refer to Professor Walker-Smith.
A What I am not doing in this document is seeking referral. What I am suggesting in this document is that they seek prompt referral to a specialist centre, and there is no specific specialist centre designated. What I am doing, as I have said, is trying to ascertain cases. In other words, if cases were arising following the MR campaign, it was important, in the absence of active surveillance of adverse events, to try and ascertain those cases. This is in much the same way as I had been instrumental in setting up the first national registry of paediatric inflammatory bowel disease. The purpose of this document and the other document to which Ms Smith refers was entirely different.
Q Doctor, “If you suspect your child has inflammatory bowel disease, prompt referral to a specialist centre is essential”; you then say why and you then say, “As a first step you should contact Dr Andrew Wakefield”. So you are saying, before a parent refers to a specialist centre to have their minds put at rest, they must come to you.
A As a first step, they could just call me. A simple call. It is not going to delay their referral at all. The referral may take some time to enact; but the simple thing to do is to get on the phone and let me know.
Q Dr Wakefield, how is any anxious parent with a child who they think has a serious inflammatory bowel disease to derive that from this document? They are going to be ringing you up for help, are they not?
A What I have said there is, “If you suspect your child has inflammatory bowel disease, prompt referral to a specialist centre is essential”. I cannot be more emphatic than that, and that gives them clear guidance on how they might proceed.
Q So you are saying that the parent of the child who gets this document is expected to read to the end of the first sentence, to understand from that that they need to go to a specialist centre, and then to read on, as a completely separate sentence, that, as a first step, they need to contact you – and understand that you are playing no role in the treatment of their child but that you would be jolly interested to hear all about it?
A That was the purpose of this information.
Q But why should they, Dr Wakefield? Why should they consult you as a first step before they start investigating the diagnosis of their child’s condition?
A I am merely trying to ascertain cases. Ms Smith is absolutely right: why, as a first step? The priority for clinical referral to a specialist centre is emphasised. It was merely a matter of being able to get on the phone to me straightaway having received this document, so that I might ascertain such cases. There is nothing more sinister than that to this document.
Q If you sent out a document like this as a researcher, it is scarcely surprising if you fetch up with parents ringing you up, under the impression that you can in some way organise a referral to the Royal Free Hospital, is it?
A No, and I am in a position of course to inform them further on that; but that is not the purpose of this document.
Q If you send a document like this to solicitors, you know that they will use that to give to their clients and that, by that method, those clients are going to fetch up, as a first step, contacting you.
A All I am concerned with in this document is ascertaining cases to determine whether there is a change in the number of cases of children presenting with this disorder.
Q What I suggest to you, doctor, in respect of this document, supplied to the solicitors, is that by virtue of it you were, in effect, aligning yourself with this litigation and with the cause behind the litigation.
A That was not the purpose of this document.
Q You must have been aware, given that you give this document to Mr Barr, that the people who come to you include people who have been sent this document by Mr Barr.
A No one comes to me for the purpose of clinical investigation; they go to a clinical centre. That would have been explained to them. The purpose of this document is for ascertaining cases, to determine whether, following that re vaccination campaign, there was indeed an increase in the prevalence of this disorder.
Q And you are adhering to that position in front of the Panel, are you, doctor: that a parent would understand that from this document? That is your position?
A If they did not, then I would have been in a position to explain it to them when they spoke to me.
Q Go on to page 185, please. This is a letter of 23 August from Mr Barr to you. Again, do not worry about the actual costs at present. I want to ask you about the second paragraph. After he has told you that there is an authorisation from the Legal Aid Board he says,
“I think we need to have a meeting about the mechanics of running the study because obviously we both have different roles to play and we also need to make sure that the investigation is as effective as possible both from your point of view and ours”.
What did you understand that to mean when you got this letter?
A I have to say I cannot remember precisely what I took it to mean, but that we were to have a meeting to talk about how individuals to be included in the study might be selected.
Q And about the mechanics of running it, because you want it to be an effective investigation of these children, both from the point of view of the litigation and from the point of view of the clinical and scientific investigation.
A From the point of view of determining whether they had the virus present in diseased tissues or not.
Q In paragraph 4 he seeks your aid in relation to possible lobbying – if that is the right word. We see at the bottom of the page reference to two particular ladies who are apparently running the two vaccine support groups,
“…both becoming very concerned about the forthcoming MMR campaign which is due to start in October. So am I! When we meet I would like to discuss this with you and perhaps engage in further correspondence with Dr Salisbury (and) the Committee on Safety of Medicines”.
So Mr Barr is enlisting your aid, is he not, in further contact with Dr Salisbury and the Committee on Safety of Medicines?
THE CHAIRMAN: I am sorry, I am just interfering at this particular stage because I have thought about it and I was looking at the dates. I just want to declare, so that everyone is aware, that I was a member of the Committee on Safety of Medicines from 1 January 1997 to 31 December 1999; but at no stage have I seen any documents between any personnel on this issue and the Committee on Safety of Medicines. I just want to put it on the record that I was a member of this particular committee during that particular period.
MS SMITH: Thank you very much, sir. In fact, you did mention it as a broad proposition, although I do not think you actually gave the dates, on a previous occasion when it was mentioned.
(To the witness) So that is Mr Barr enlisting your aid, is it not, in lobbying, in effect, with Dr Salisbury and the Committee on Safety of Medicines?
A He is seeking a meeting where we will have further discussions, presumably about entering into further correspondence with Dr Salisbury about safety matters in relation to the forthcoming MMR re-vaccination campaign.
Q And you thought that was perfectly appropriate, for you to play that role in collaboration, conjunction, with Mr Barr and with the two ladies from the vaccine support groups, whilst acting as an expert? You did not find anything uncomfortable about that?
A I am not sure that that statement is represented in this letter at all.
Q No, it is what I am asking you. Did you feel any discomfort in having that suggestion put to you? We will see that you carried it into action a little later on.
A In essence, here were a group of people who were concerned about the safety or dangers of a re-vaccination campaign which had never undergone any safety testing; and that seemed to be an entirely legitimate concern and something that I was perfectly happy to discuss with Richard Barr.
Q Dr Wakefield, what I asked you was whether you had any discomfort in having your aid enlisted in this way to go and lobby Dr Salisbury and have correspondence with the Committee on Safety of Medicines, which you were well aware would be anti-vaccine in effect; would be saying that there were concerns in relation to the vaccine. Did you have any discomfort about being asked to do that when you were acting, you have told us, as an objective expert in the litigation?
A Can I just take exception to the term “anti-vaccine”? Our concerns were about the safety of the vaccines, not the merits of vaccination. I am not anti-vaccine. As I have said, my first two children received the MMR vaccine. I was already in correspondence with Dr David Salisbury. I never entered into correspondence jointly with Mr Barr in relation to David Salisbury, and I have never had any communication in this matter, as far as I am aware, with the Committee on Safety of Medicines.
Q So you are saying you did not interpret that suggestion as being a suggestion that you should align yourself to a cause in any way?
A It was a suggestion that there should be discussions in relation to further correspondence with the Department of Health.
Q We will go on to see how you responded to it in a moment but, before we do so, there is a newsletter at page 190. This is a description of the pilot study that Mr Barr thinks is going to be undertaken. At the top of the page,
“If we can prove a clear link between the vaccines and autism/(IBD) this will be exceedingly useful not only for cases involving those conditions, but also for other types of damage such as epilepsy.
To obtain the evidence to do this, we will be running a pilot study. Around 10 children with symptoms which are closely linked to the vaccine will be extensively tested by a team of doctors headed by Dr Wakefield at the Royal Free….
We will be selecting children to take part in the study from details and medical notes we already have. The investigations will involve a whole battery of tests, to be carried out by a number of leading experts in their fields”.
He then says he will be liaising with the families and the doctors will give “full details of what will be involved”. It would appear, would it not, that Mr Barr is under the impression that a team headed by you were going to be carrying out a battery of tests?
A That would seem to be his impression, but it is not one upon which I can shed any further light.
Q If we turn over a couple of pages to page 193…. Sir, I see that it is five past three and this is rather a long letter. Would you like to take a break before I begin on it?
THE CHAIRMAN: Yes, I think that it would probably be appropriate to adjourn, to give us a break and also to give Dr Wakefield a break. We will now adjourn and resume at 3.25 p.m. Dr Wakefield, please remember that you are still under oath.
(The Panel adjourned for a short time)
THE CHAIRMAN: Ms Smith.
MS SMITH; Thank you, Sir. Dr Wakefield, I was turning on to a letter at page 193 in FTP1. Just so that we are aware of the date, that is 7 September and you are writing to the Chief Medical Officer, Dr Calman, is that correct?
A Correct.
Q If we just look back at 185, that is a couple of weeks after the letter I had just been asking you about where Mr Barr was saying that the two vaccine support groups and he were worrying about the forthcoming campaign and eliciting some discussion from you as to further correspondence with Dr Salisbury or the Committee on Safety of Medicines.
A That is correct.
Q This is, in effect, a letter which you sent to Dr Calman on the very self-same subject that Mr Barr was wishing to discuss with you.
A Yes, the merits of re-vaccination with MMR.
Q Was that as a response to the concerns that Mr Barr had or was it an independent view of your own which coincided with his views?
A It was part of a series of communications that I had undertaken with the Department of Health since 1992 in relation to the safety of measles-containing vaccines and timely in as much as a re-vaccination campaign with MMR was anticipated.
Q And it was coincident with the views that you shared with Mr Barr in relation to the need to express your views to the Department of Health in relation to the re-vaccination programme, is that fair?
A Indeed, it was only appropriate to bring our concerns to the attention of Dr Calman.
Q So that was what Mr Barr felt, what the two ladies who he refers to in his letter who ran the vaccine pressure groups and you all felt at that time.
A I do not know what the other two felt; I do not remember discussing this with them and I do not ever remember having met with or spoken to Rosemary Fox in particular. I have spoken with Jackie Fletcher and I may well have met Rosemary Fox at some stage, but I have no idea – there was no meeting that took place between the four of us in relation to this.
Q This is a very long letter, Doctor, and it deals with a lot of science. I do not want to inhibit you from asking the Panel to look at any particular aspect but I am not going to read it all out because, as I say, it is a long letter and I am interested in exploring with you the message of the letter rather than the justifications behind it. As I say, if you wish to refer to parts of it, please do not let me inhibit you, but you start off to Dr Calman by saying that you want to write to express formally your anxieties over the intention to re-vaccinate and you say:
“I will not go over the history of our exchanges on this subject; this will emerge at the appropriate time.”
What did you mean by that?
A I imagine as and when the issue was resolved one way or another.
Q You go on: “I feel sure that your independent expert advisers will have alerted you …” and then you go to the particular matters on which you say they should have alerted him. “Doubtless they have also informed you that the measles vaccine induces …” a particular immune response. Did you mean that literally, Doctor, or were you in effect being sarcastic? Were you saying I feel sure they will have alerted you and doubtless they will have informed you because you did not think they had, or were you literally saying they will have told you all this?
A I am saying that they will have told him this. JCVI assimilate and review all the papers in relation to this matter and hopefully they will have brought this to his attention.
Q You say, “You will also have seen our recent paper in The Lancet …” and we must remember of course that that is not The Lancet paper that we are discussing, that is the one in relation to the causal association between measles and Crohn’s. Then you say, “In the future you may have cause to reflect on the ‘independence’ of your appointed experts …” and you mention two in particular, and you say they cannot be considered independent.
“If I and my colleagues are right, then they are wrong. Their scientific and professional standing and credibility is inextricably linked to the success of measles vaccination.”
You are accusing them there, as I understand it, of a lack of independence; you had the same vested interest in establishing the opposite, namely that vaccines were causing damage, did you not?
A That is not the issue at stake here. Whether or not the vaccines caused damage would be established quite independently of this issue; what I am trying to bring to their attention here is the absence of any safety studies of this policy.
Q I am not asking you about that, Dr Wakefield, I am asking you about your observations on these two. You say:
“Their scientific and professional standing and credibility is inextricably linked to the success of measles vaccination.”
In other words you are saying – and you are perfectly entitled to that view – you do not think that they were giving independent advice, and I am asking you why it is that precisely the same cannot be said of you the other way round.
A It could and it has.
Q Did you recognise that at that time?
A Yes, indeed, throughout and I was cautious in my early exchanges to make the very point that we do not know the answer, but in the absence of an answer one has to proceed with an abundance of caution and to conduct a re-vaccination campaign in the absence of an abundance of caution, in the absence of appropriate safety studies, struck me as being ill-advised.
Q You then go into the science of your position and then if we turn on to page 196:
“It is my concern that the expert advice that you have received has been deficient, and far from independent. If and when the dam bursts it will be you and your department that is standing in the way. We, for our part, have tried to help, only to have our work denigrated and misrepresented. We went into this with our eyes open and will continue to generate peer-reviewed, published data in the true scientific spirit: there is a vast gulf between this and opinion. You may wish to ask your experts what are the longest prospective safety trials of measles vaccine, MMR and measles re-vaccination at any time, anywhere in the world. The result may surprise you.
Do not re-vaccinate.”
You wrote that letter feeling extremely strongly and rather angry, would that be fair?
A I think frustration rather than anger.
Q Extremely strongly.
A Yes.
Q But nonetheless you were comfortable about writing a letter in those terms to the Chief Medical Officer at the same time that you were advising as an independent expert in the MMR litigation, did you?
A Yes, indeed, and in fact it was far more important to avoid further potential problems by at least making an effort to make contact with the Chief Medical Officer than it was to act as a medical expert in litigation.
Q You were united, were you not, with the cause that Mr Barr and his litigants were signed up to, you had the same cause.
A I think that the term “cause” might be construed as pejorative, as some sort of crusade. That is not what this is, this is a genuine, sustained and well-founded attempt to bring to the attention of the relevant authorities concerns about the safety of these vaccines which I considered and indeed others considered to be ill-tested.
Q You were sufficiently certain that your position was right to try and stop in effect the programme that was envisaged.
A In the absence of a safety study, even a single safety study of re-vaccination, it was not, in my opinion, appropriate to proceed with a population-based re-vaccination campaign with the only mechanism for ascertaining adverse events the passive surveillance system that I described to the Panel earlier.
Q You were sufficiently convinced of the rightness of your position in your own mind to be advocating that there should be no re-vaccination – that is how you end the letter, “Do not re-vaccinate” – underlined.
A I am sufficiently concerned, not about the rightness of the work that we are doing, that was work in evolution, but about the position, as you say, that I did not think it was appropriate to re-vaccinate.
Q I suggest to you, Dr Wakefield – and there is nothing wrong with this – that you were very, very strongly aligned and expressly aligned to a cause in that letter.
A If the cause is one of first do no harm then the answer is – again, the word “cause” is inappropriate and I reject it.
Q If we do not use the word cause I do not really mind what word we use, we will use “concern” if it makes you more comfortable. The fact is, it is exactly the same concern that was being expressed to you two weeks earlier by the solicitor who is running the MMR litigation and who also tells you that it is the concern of two vaccine support groups.
A I am not in a position to say what their specific concerns were. My specific concerns are set out in detail in my letter to Dr Calman.
Q If we turn on, please, to page 237 – again, do not worry about the money at this moment, but that was a letter in September 1996 from you to Mr Barr saying that you were ready to start work on the Legal Aid Board study, is that correct?
A Correct.
Q The next thing that you helped Mr Barr with is a survey for the litigation. Can we go to page 317? This is a letter that Mr Barr writes to Mrs Cowie at the Legal Aid Board, and the part that I want to ask you about is on the second page, 318, at the bottom of the page:
“I would like to try to establish that there is a fairly consistent time link between the administration of the vaccine (MMR) and the onset of autistic features. To achieve this we have prepared a survey questionnaire (enclosed). This has been approved by Dr Wakefield.”
Is that correct?
A If he says so, yes.
Q Well, what do you mean by that? Do you remember being involved with a survey or not?
A To the extent that I will have reviewed the document, yes.
Q Not only that, because if we go on to the last four sentences:
“Dr Wakefield feels that if we can show a clear time link between the vaccination and the onset of symptoms we should be able to dispose of the suggestion that it is simply a chance encounter. The reason for this is that there is quite a wide range of ages between which the vaccination is administered. If we can show that the onset of the autism is related in time to the vaccine we should be able to establish the point that it is no coincidence that children become autistic after the vaccination. To set up and send out this survey will involve some additional costs.”
And he then sets out the actual costs of producing it. After that he says:
“After that analysis and collation of the report by Kirsten Limb and myself plus diagnosis with Dr Wakefield (along with his fee for examining the data and possibly writing up the report himself)…”
And then he gives further figures. You approved the survey, according to that, and you were the one who was intending to do the analysis on it. Is that correct?
A Yes. I do not think that this survey was actually ever done. I certainly was involved in no analysis and received no data in respect of this survey.
Q It was aimed to dispose of the suggestion, as we see, that it was a chance encounter with MMR, and I suggest to you that it was also aimed at proving what you already thought to be the case – plainly thought to be the case – namely that vaccine was implicated in serious morbidity for children?
A It was one way of trying to determine whether there was a causal association or not, yes.
Q If we go on, just for the sake of completeness, to page 322 we see this survey. At page 324 a very, very clear distinction is drawn for the purposes of those who are going to fill in this survey between MR and MMR. Is that correct?
A Yes, correct.
Q Dr Wakefield, I just want to revert to this question of what you were aware of in respect of the parents who were contacting you. Are you suggesting that in contact with you none of them mentioned the fact that they were thinking about proceedings against the vaccine manufacturers?
A I have absolutely no memory of anyone reporting that to me. I can report how they say they came to be aware of me and based upon what they told me, but I cannot remember any of them having said that they were pursuing litigation except the child JS.
Q But you agreed that you were approached and agreed to act as an expert. Are you saying you thought the litigation in which you were an expert was utterly unconnected with the parents who were making inquiries from you?
A That is not what I said. What was in the parents’ mind I am completely unable to say, other than the priority for their desire for referral was the well-being of their child.
Q As far as you were concerned, the work with Dawbarns was important to your research on an ongoing basis, was it not?
A No, it was not.
Q Not important ---
A These children were going to come for clinical care whether or not there was litigation.
Q Not important to the funding of your research?
A The funding that Dawbarns got, or the Legal Aid Board funding, should be looked on as a grant. Simply that, a grant to conduct a piece of research. Had it not come from the Legal Aid Board, then it would have been obtained from somewhere else. It was simply that – a grant.
Q Could I ask you please to go on, and we are going chronologically through these bundles, to page 357a of the bundle. This is a letter from Sawyer, Edwards and Butler and it is addressed to Professor Pounder and to you. Sawyer, Edwards and Butler appear to be a company who have some involvement in the planning of fund-raising activities. Is that correct?
A That is correct. Sawyer, Edwards and Butler were taken on as private fund raisers for medical research by my group.
Q This is a letter dated 18 December 1996. Would you turn over, please, to page 357c, we see in this letter in December 1996 just under paragraph 3:
“The priorities for 1997 are therefore:”
And they then set out a number of bullet points. I want to ask you about the third bullet point.
“To explore community fundraising opportunities. The increasing weight of publicity devoted to the tissues addressed by the IBDSG [Inflammatory Bowel Disease Study Group] and the attention reflected onto the work by the activities of Messrs Dawbarns, creates an opportunity for the IBDSG to attract more general contributions. With your agreement, Mike Butler will formally arrange meetings with JABS and National Addiction Centre, 3Cs”
which I think you will accept are also vaccine support groups –
“and a few other small organisations with a mutual interest in the activities of the IBDSG to explore collaboration on this issue. Once this has been completed and the charity registered, we will draft and produce some low cost printed materials and arrange their distribution, with the aim of developing our own dedicated community fundraising programme.”
I suggest, doctor, that that is the clearest possible statement of an intention to exploit the connection with Dawbarns and with these vaccine support groups for fundraising purposes for the inflammatory bowel disease study group?
A Two points to make. The NACC is the National Association for Crohn's and Colitis. It has nothing whatsoever to do with vaccination. 3Cs is the Crohn's and Colitis in Childhood organisation. It has absolutely nothing to do with vaccination. This was a suggestion put forward by Mr Robert Sawyer, and it was never taken up.
Q But the suggestion that Mr Sawyer made must have arisen out of information that you gave him when you employed him as a private fundraiser?
A I am not sure how one could come to the conclusion that I provided him with that information he may well have come by himself. He certainly knew that I was acting as an expert in the litigation. Nonetheless, this proposal put forward by Robert Sawyer was not taken up because it was not considered appropriate.
Q Dr Wakefield, I said to you it was the clearest possible statement of an intention to exploit the connection with Dawbarns. You are telling us that Mr Sawyer or Mr Butler, whoever it was who dealt with it, somehow found out about the activities of Dawbarns and, of his own volition, decided that it was creating an opportunity for the inflammatory bowel disease study group?
A No. Ms Smith said, “This is how will have come to hear about it.” I am saying I do not know how Mr Robert Sawyer came to know about it, and there are many mechanisms by which he may have come to know about it. Whatever his suggestion, it was not taken up.
Q We understand it was not taken up and that is not what I am asking you. I am asking you about why it is that a private fundraiser employed by you is not only referring to the activities of Messrs Dawbarns but is actually saying that you should use the publicity that has been devoted to the issues addressed by your group, of which you were the Research Director, to raise more funds. How can he possibly have come by that as a plan, save by you and Professor Pounder telling him about the activities of Dawbarns? How did they relate to you? He may have known of them independently, but how would he know they had anything to do with the inflammatory bowel disease study group?
A There was no secret at all that I was an expert and agreed to act as an expert. It was not a secret to him or to anyone else. This was his suggestion. I cannot speak to it. All I can say is, it was never acted upon.
Q Can we go on, please, going into FTP2, just to follow through the chronology. It is page 610. This happens to be a document where it is an MMR newsletter, but I am not going to it for that purpose. I just want to ask you where the information that was being given to the litigants there is correct. The third paragraph down:
“Kirsten Limb, Richard Barr, Jackie Fletcher and the parents of a vaccine damaged child met Tessa Jowell … along with the Chief Medical Officer … and Dr David Salisbury. Dr Andrew Wakefield and Professor Walker-Smith from the Royal Free Hospital also came to the meeting and addressed the Minister on their concerns about the safety of the vaccines.”
Is that correct?
A That is correct.
Q That is in October 1997. Then I want you to go on to FTP3, please, page 1079. You were asked briefly about this document by Mr Coonan. This is a further costing proposal for the Legal Aid Board and the only thing that I want to ask you about it in this context is that you say half way down it, or it may be that it was said – I know not – by the lawyers:
“The evidence so far includes:
- A striking temporal relationship between MMR exposure and onset of symptoms in many children.
- A new syndrome involving swelling of the lymph glands in the intestine and inflammation of the lining of the large bowel.”
It would appear, would it not, that you were relying there on the findings which were written up in The Lancet, in the paper with which we are concerned, as evidence for the litigation?
A I am not sure of the date of this, but it depends on how many children. Clearly, if it were a document that arose some time during 1997 it may reflect upwards of 50 or 60 children; so I am unable to give any further advice on that, unless anyone can put a date on this document.
Q Fifty or 60 children which started off with The Lancet children; it includes The Lancet children. They, as we know, are where you discover your new syndrome.
A That is correct.
Q There is one matter arising out of that. You have told us you were working, albeit in a research role, very closely with Professor Walker-Smith and that you were often on the ward. Is that correct?
A I do not think I said that.
Q You said that you saw the children in out-patients.
A That is a very different matter. I did see the children in out-patients. I rarely went to the ward.
Q I think you did accept that you indeed intended to be present at out patient consultations whenever you could.
A Whenever I could, yes.
Q It would be normal presumably for the children to attend those out patient consultations with their parents?
A That is correct.
Q And for them to give information to Professor Walker-Smith at those out patient appointments?
A Absolutely.
Q Perhaps I can just ask you to go back to FTP1, please, and 370aa, which is a blue document. This is written in February 1997. We know that by that time – and you are very welcome to look at your list at D8, if you wish to – the last of The Lancet children, Child 10, had been investigated. He was admitted a few days before that letter, on 16 February, and you tell us that The Lancet children were the first 12. Is that correct?
A That is correct.
Q Professor Walker-Smith in this letter says, “Never before in my career have I been confronted by litigant parents of research work in progress”. He then says that he thinks that is going to make the work difficult. He is making reference to that as a striking phenomenon, is he not? In other words, the first time in his career that he has come across it.
A That is correct.
Q Given that you were attending the out-patients appointments of many of these children, it must have been no less striking to you than it was for him, Dr Wakefield.
A Again, I am not sure how Professor Walker-Smith came by this knowledge that all parents were litigants. Certainly in his statement, according to my understanding, there was one parent in the first 12 who, at the time of their colonoscopy, had been awarded a Legal Aid certificate. At the time of the patient’s referral – that is, Child 12 – I was aware, through Mrs 12, that she had met Mrs 6 at a parent-toddler group meeting, and that is how she became aware of what we were doing and that is why she had sought referral to Professor Walker-Smith. That is my understanding. So I cannot speak to this particular letter and I will leave that to Professor Walker-Smith.
Q You have referred to one child, Dr Wakefield. I am not asking you about Legal Aid certificates; I am asking you about whether you were aware that many of these children were in the litigation, in the sense of being potential litigants. It appears that Professor Walker-Smith regards himself as having been “confronted by litigant parents of research work in progress”. You are telling us, are you, that that was not something that you knew anything about? That Professor Walker-Smith must have learned that on occasions when you were not present?
A That makes the assumption that this matter was communicated to Professor Walker-Smith during the out-patients. It may have been as part of the referral of the children who were coming through; it may have been by letter or communication directly to him from the parents. I can say that, by the end of 1996, I was aware and I believe others were aware that, for example, Mrs 2, I believe, had, pursuant of her child’s investigation at the Royal Free, decided to pursue litigation. So there was a rising tide of litigation – that is for sure.
Q You have referred to two children. That does not make the kind of rising tide that is apparently confronting Professor Walker-Smith at this time, does it?
A Again, I am unable to speak to Professor Walker-Smith’s letter specifically. I can only tell you what my own memory was.
Q Just so that we are clear, I did not make an assumption. What I asked you, doctor, was whether you are saying that any information gleaned by Professor Walker-Smith in relation to involvement by parents in litigation – whether you are saying that all that information must have come to him at times when you were not present. In other words, you knew nothing of what he was talking about, except in relation to two individual children.
A No, I am saying I have a memory of litigation being an issue at some stage in two of the children. I have no doubt that the word spread very rapidly via parent networks and litigation was pursued, and this is an issue with which we were confronted; but, again, I cannot speak specifically to the memories or the letter of Professor Walker-Smith.
Q Perhaps you will feel more comfortable with your own letter, which is at page 366b. “Further to our meeting on Tuesday 21 January”, you say to Professor Walker Smith,
“I thought it important to write to you to clarify my role in the legal issues. I fully appreciate your desire not to become involved in the legal aspects of these cases, but I feel it is important to express the reasons that I do feel obliged to become involved…”
and you then set them out at some length. So the fact is that, when you wrote that letter, you were plainly addressing concerns that the parents, who were being seen as part of this study, were also parents who were in some way or another actively investigating litigation.
A I am afraid I do not follow that line of logic. What I had agreed – and this is absolutely no secret to the Panel at all – was that, early in 1996, I had agreed to act as an expert.
Q We see that because, if we go on to page 366c, you say,
“…I have considered at great length. It may not be the wish of others within the group to become involved. It falls to me to make sure that their legal cases are presented in the best possible light”.
Is that correct?
A That is absolutely correct, yes.
Q That is what you regard as being an independent expert, is it? An objective expert, Dr Wakefield?
A The presentation of the cases “in the best possible light” means, as far as I am concerned, the most objective science that I am capable of bringing to bear on this particular situation. In other words, is the virus present or is it not present?
Q There is one last document I want to ask you about, please, in this section. It is at FTP2, page 693.
THE CHAIRMAN: Page 693?
MS SMITH: I am sorry, page 691. Just to orientate you, doctor, you can see what it is. This was the clinical research protocol for the trial that you were proposing to do into transfer factor. I am not asking you anything about the substantive matters in that document, but I do want to ask you about page 693. At the bottom of the page, where you are giving the background, you say,
“Conclusions of the Clinical Study: We have identified significant gastrointestinal pathology in association with developmental regression in a selected group of previously, apparently normal children. In the majority there is a clear temporal association with possible environmental triggers”.
That is a clear reference, I think you would accept, to The Lancet paper. You then say,
“We are aware of some 554 children who require investigation for similar symptoms, many of whom have been, or are in the process of being referred”.
The only question I wanted to ask you was how, as a researcher, were you aware of such a specific number as 554 children awaiting investigation at the Royal Free?
A This will have been through XXX, I believe, which was an organisation which Mrs 2 joined – this is my memory. It is through that organisation that many, many of the referrals came. That is where this figure is likely to have come from.
Q So that was a specific number of children, 554, who were in the wings, if you like, in relation to referral to the Royal Free in relation to your new syndrome?
A It is perhaps over-emphatic to say that they require investigation; perhaps they require consideration of investigation, since we did not know a great deal about many of these children. Ultimately, by the time I left the Royal Free I think that about 180 had actually been seen.
Q Why does that figure come to you from XXX? Why do you need to know exactly how many children are going to require referral?
A I suppose it is by way of giving background information as to the likely or possible merits of conducting such a trial. In other words, trying to set the scene of what the background population who might ultimately benefit from this therapy, should it prove to be effective, would come from.
Q (To the Panel) Sir, I am going on to a new section. I do not know how everybody feels. I am perfectly happy to do so, but I will not finish it tonight.
THE CHAIRMAN: It is ten past four now, so we will now adjourn. I am sure that Dr Wakefield has had a long enough day today. We will now adjourn and resume at 9.30 tomorrow morning. I will just give you my usual reminder and warning, Dr Wakefield. You are still under oath and still in the middle of giving evidence.
(The Panel adjourned until Wednesday 16 April 2008 at 9.30 a.m.)
