GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Friday 11 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 FIFTY-EIGHT)
(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-examination by MR HOPKINS, contd 1
Cross-examined by MS SMITH 2
THE CHAIRMAN: Good morning, everyone. I have been informed, Mr Hopkins, you have a question of clarification for the witness?
MR HOPKINS: Yes, sir.
THE CHAIRMAN: Ms Smith, I hope you do not mind if Mr Hopkins puts a question for clarification.
MS SMITH: Of course not, no.
MR HOPKINS: Sir, I have alerted other counsel to the matter I wish to raise.
ANDREW JEREMY WAKEFIELD, continued.
Cross-examined by MR HOPKINS, contd
MR HOPKINS: Dr Wakefield, I was questioning you yesterday about the cessation of lumber punctures and I wish to correct something following Professor Murch’s further consideration of the point, and for that you will need to look at yesterday’s transcript, which is Day 57 which I hope is with the Panel. Could a copy be handed to Dr Wakefield as well? (Same handed) If you would go to page 34 of the transcript, at letter F, the question starts when I ask you about the cessation of lumbar punctures and I was suggesting that Child 7 had been a child who had been sent by Dr Berelowitz and following that it had caused Dr Berelowitz to consider the child did not have a disintegrative disorder or a similar condition. On behalf of Professor Murch we would like to correct that to Child 10, and just so you can see where that fits in with the chronology at D8, and let me pass that to you so you have the chronology in front of you (Same handed) you will see going almost to the bottom of D8 the chronology is that Child 10 was admitted on 16 February 1997 and then investigations followed after that. So, the thrust of the question I put to you remains the same but the identity of the child we believe now was probably Child 10: does that in any way affect the answer or standpoint that you have taken on this?
A Not at all.
MR HOPKINS: Just for the Panel’s reference, you dealt with this in chief in answering questions from Mr Coonan, and that was on Day 49/24/G where you gave an answer to a similar effect. I just wanted you to have an opportunity to deal with it.
Sir, thank you for that.
THE CHAIRMAN: Thank you Mr Hopkins. Ms Smith, we now go to you for you to start your cross-examination so the ball is now well and truly in your court.
MS SMITH: Thank you.
Cross-examined by MS SMITH
MS SMITH: Just a couple of practicalities first of all: Dr Wakefield I have elevated my microphone, can you hear me comfortably?
A Yes, I can.
Q If at any time you cannot hear, because this is the nearest they have been able to get us but we are still a long way away, please say so, and, secondly, as you know, we have got a lot of matters to cover and I am going to be taking you to quite a number of documents. If you want longer to put them into context in your own mind, or to read them, or you want me to go more slowly please say so.
A Thank you.
Q I want to ask you first of all a few questions which are a recap of what you have told the Panel already in relation to your employment, please. As far as your evidence so far,
I think your employment at the Royal Free was that you were firstly appointed to senior lecturer in experimental gastroenterology in the departments of medicine and histopathology – and you explained the significance of that – in January 1993, is that correct?
A I believe so, without reference to the documentation, yes.
Q Then, ultimately, in 1997 you were promoted to reader.
A I believe that is correct, yes.
Q We have heard that you were the Research Director of the inflammatory bowel disease study group.
A Correct.
Q I want to pick up what that entailed, if you please, and I think the easiest way would be to go to the job description that we have, which is at FTP1 at page 40. You have told us this is a document that you have no specific recollection of seeing but you are prepared to accept that you have seen it. You have been taken to it so far in relation to restrictions, if you like, on what you were doing but that is not the reason I am going to it for the present questions, it just seemed to be a description that I wanted to see whether you accepted, in particular in relation to your job (three lines down) Chairman and Research Director of the Inflammatory Bowel Disease Study Group at the Royal Free Hospital School of Medicine. We see that that group was a collaborative research effort involving 50 clinicians and scientists based at the Royal Free Hospital and worldwide. The post involves developing both long-term research strategies for the investigation of ulcerative colitis and Crohn’s disease and non-steroidal enteropathy, and it was combined with the day-to-day running and supervision of research projects involving two PhD students, four MD students and one MS student. Then we see that it says you were in charge of the day-to-day activities of a number of graduate scientists working with the group, and in addition you were charged with raising funds for the group from government run bodies, research-based charities and other government departments. The overall aim was to provide leadership and strategic research initiatives that would make the Royal Free Hampstead NHS Trust and the school of medicine the world leader in inflammatory bowel disease research. Is that a fair description of what your job overall entailed?
A Yes, I think it requires some clarification perhaps. For example, the term “laboratory based” that may conjure up in the minds of the Panel someone exclusively dealing with test tubes. I had a laboratory and within that laboratory I had a number of scientists who were, for example, involved in clinically based studies, clinical trials, epidemiological studies, that is population-based studies, but they were in essence based in my laboratory, so that point perhaps requires a little clarification.
Q I am quite happy to come back to that, indeed, I will be asking you about the rest of the description at a later stage, but as far as the overall responsibility that you had and the aims that you had in relation to those responsibilities and the supervision duties you had and the research fund-raising duties you had is it a fair overall description?
A I think it is, yes.
Q So it would be fair to say that it is a highly demanding job?
A Yes, it is.
Q Intellectually challenging, would that be fair?
A Yes.
Q Exciting?
A At times.
Q With ambitious aims for the future status of the study group which you were leading?
A I think, yes, based upon the early discoveries that we had made we felt – and in particular in the way that it had been received by the medical community – we felt that there was a major break through, particularly in Crohn’s disease, and that could, indeed, put us in a position of some – in the vanguard if you like, of this particular area of research.
Q So that is those hats, if you like, that you had, and we have also heard that you had an honorary consultant appointment in experimental gastroenterology from 1994 until you left the Royal Free in 2001, is that correct?
A Correct, I believe.
Q Since 2001 you have had two appointments, you have told us, one for the charity VISCERAL and one for your present employment at Thoughtful House in Texas.
A Yes. In the interim there was an effort to establish a centre in Florida, which came to nothing, but, yes, those were my two designated appointments.
Q And as far as those two appointments are concerned, neither of them entailed direct clinical work, is that correct?
A That is correct.
Q Have they involved research?
A Very much so, yes.
Q All that research has been into the area of interest which culminated with the discovery, if you like, of the syndrome that you believe affected the 12 Lancet children, in other words inflammatory bowel and developmental disorders.
A Are you referring to the research subsequent to my departure from the Royal Free or ---
Q Yes, I am asking you about your two appointments, one with the charity VISCERAL and one with Thoughtful House?
A No, the discoveries were made during the time of my employment at the Royal Free, or the initial discoveries of bowel disease in children with autism were made there and the work ---
Q And the work was – I am sorry, I interrupted you, please continue.
A The work since then has, as I believe I gave in response to Mr Coonan, was to try and create an environment or determine what kind of environment that children with autism and bowel disease in particular might require to get the best for them, in other words, a clinical centre, an educational centre, specifically with the use of a technique called applied behaviour analysis, an education technique, and research, that triumvirate of disciplines that could provide the optimum care for these children, and that is what was ultimately established in Texas.
Q So it is a continuum, if you like, of your interest in the connections between inflammatory bowel disease and behavioural disorders, developmental disorders?
A Absolutely.
Q I would like to turn to you CV, and although there is one in the FTP bundles you have produced an up-to-date one which I am content to look at, which is at D2/tab 9, if we go to page 2 that sets out your qualifications and appointments. Do you have it?
A Not yet.
THE CHAIRMAN: Just to correct it in the meantime, the first page of the CV is numbered three, the second one is numbered two and the third one is again number three, so that is a typo and it should be one.
MS SMITH: The third page after the title page is the one I am invited Dr Wakefield to look at. (To the witness after a pause to locate D2) I am inviting you to go to the third page of your CV, which are your qualifications and appointments.
A I have it, yes.
Q We can see from that that you trained as a surgeon, is that correct?
A Correct.
Q The clinical training that you had, I think apart from a very short period as a very junior doctor, was in surgery?
A Yes, it was in surgery.
Q That was the situation up until 1986 when you embarked on a research career with a Wellcome research appointment.
A That is correct, yes.
Q That research appointment, which was in the States, I think you told us, was in experimental transplantation of the small intestine?
A Perhaps I should just clarify: at that time all surgeons in training were required to do a period of research and so it was not embarking on a research career, it was undertaking a period of research with the anticipation of going back into clinical surgery after the conclusion of that.
Q The area of research which you chose, experimental transplantation of the small intestine, was drawing on your surgical training, it was an extension, if you like, of the surgical training you have received?
A Yes, it was the project that I specifically went to undertake.
Q You were there for nearly two years and then you came to the Royal Free Hospital?
A When I came back initially I applied for a job at St Mary’s Hospital and undertook a locum, senior registrar locum in surgery there. I worked on the liver transplant programme at King’s College Hospital, purely on a voluntary basis, assisting in liver transplantation, and then took up a similar position at the Royal Free where I undertook, also undertook a clinical locum on behalf of the professor of surgery as his lecturer for a period.
Q You have anticipated the question that I was going to ask you, which was, you told us that you had had some clinical locums and some clinical work on the liver transplant unit, and that was all clinical work in surgery?
A Correct, yes.
Q From the end of that time onwards, say 1989, you have done no clinical work at all, is that correct?
A That is correct.
Q When you were appointed in January 1993 as a senior lecturer in experimental gastroenterology you were by then about seven years into research, including your period in the States.
A Yes. By way of clarification, I am sure this is what you mean but I was not dealing on a day to day basis in the clinical management with patients, their executive decision-making process of diagnosis and treatment. My research, however, was clinically based; in other words, in Chron’s disease, colitis and other human pathologies.
Q Mr Coonan asked you to describe your practice since 1990, Dr Wakefield, and you said “clinical and experimental research”, would that be fair?
A And that sums it up, yes.
Q By that you mean clinical research, in other words research which involves human subjects, patients and some pure lab work?
A Correct.
Q When you began that work you told us that it related to the possible vascular blood vessel origins of Chron’s disease?
A Yes.
Q So that is how you arrived there. You have told us that you had no formal qualifications in pathology, is that correct?
A By examination, no.
Q And you have told us that in fact you have not acted as a pathologist.
A I have not acted as a clinical pathologist, no.
Q We may have to return to that but that is your position at the moment. You have no formal qualifications in paediatrics, is that correct
A That is correct. I did spend a period of nine months as a paediatric surgeon at St. George’s – I think it was nine months – but I have no qualifications by examination in paediatrics.
Q That of course we can see at the bottom of the page, you were a registrar to Miss Gordon in paediatric surgery for eight or nine months from April to November 1986.
A Correct.
Q I want to ask you again in broad terms, first of all, about your honorary clinical contract in the hospital at the Royal Free, and for this if you would, please, go back to FTP1, the job description, page 40. It may be that we do not have to spend very long on this, Dr Wakefield, because, as I understand it, you accept, although you do not have any firm recollection of seeing this particular document, that it describes your job but you have a view on the interpretation of the words that are used to describe it, would that be fair?
A Correct.
Q And the words that you particularly think have to be interpreted are those which say at the top that you were involved exclusively with laboratory based research, and indeed you have already alluded to that when I was asking you the initial questions, and the words at the bottom where we see:
“His research involves the laboratory investigation of resected human tissues, but he will not be involved either in the clinical management of patients …”
And you felt that needed interpretation.
“… with inflammatory bowel disease or the routine histopathological reporting of tissues from these patients. He will not be involved in the out-patient or in-patient management of patients in the Royal Free Hampstead Trust.”
And you felt again that that needed to be interpreted, is that correct?
A That is correct.
Q And your point, as I understand it, is that since you were engaged in clinical research, that is research involving patients, you had to have some interaction with clinical colleagues.
A Yes.
Q We heard from Professor Hodgson, you may recall, or may have read, that an honorary clinical contract in these circumstances for an academic who has nothing whatsoever to do with individual patients, but none the less is in the field of human medicine, the honorary contract, he told us, confers on that doctor the ability to conduct clinical teaching rounds, see and participate in conferences about patients but not be clinically engaged; and I think you would accept that, would you not? I am very happy to go through it again, if you wish me to?
A No, that is fine. Again, I would interpret the word “engaged” if that is the word that Professor Hodgson used, in the same way that I would interpret the word management in my job description, and that is exclusively in the executive decision-making role in terms of individual patient investigation, diagnosis, prescription and treatment.
Q I think that you would accept that at least at first glance the exclusions in your job description are in fairly comprehensive terms, as far as your engagement in clinical management of patients?
A I think that the purpose of the way that they were set out was to reassure the executive of the Trust that I would not be involved in the clinical management of patients in the way that I have described.
Q And most importantly I think that would cover that you could not engage in activity which entails you assuming any clinical responsibility.
A If by “clinical responsibility” one is confining the description to that which
I have applied to the word “management”, that is the executive decision-making in terms of making a diagnosis in a patient, ordering treatment, then I would agree.
I would not accept it in the context of arranging a clinical test to be undertaken, which is, for current purposes, undertaken by the lowliest member of staff on the ward, the clerk, who files these forms for ordering investigation, which was my role specifically in the examination of the children with autism.
Q We will revert to the lowliness of your role in relation to these particular children shortly, Dr Wakefield, but perhaps I can ask you this first. Would you agree that for a professional such as yourself, with a job description such as this, that the performance of your duties in accordance with what your employers expect of you is a matter of trust. In other words, you would not expect to be policed to make sure that you were doing in the way you should be.
A I am sorry, could you repeat that last bit again?
Q Yes. I said, in other words you would not expect to be policed to ensure that you were carrying out your job in the way that you should be? You would expect your employers to trust you to do what was appropriate as a senior doctor?
A Yes, I would but implicit in my day to day functioning was interaction with senior colleagues to whom it was evident what my conduct was, so I would not expect to be policed in that way unless there was a reason or a complaint or a problem.
Q You have raised the issue of your involvement with the particular children who we are subsequently going to be looking at, and I want to be clear about this: is the Panel to understand from what you say of your interpretation of your job description that your involvement with the children that we are considering arose exclusively from the pursuit of your research?
A No. As I made clear in my description in particular of Child 2, when the mother,
Mrs 2, made contact with me in May 1995 I had no interest in this area of research at all; I knew nothing about autism, nothing at all. My interest on behalf of Child 2 – and subsequently other children who came to be known to me through spontaneous contact by their parents – was to try and help the parents gain access to a clinician with sufficient expertise and insight that he might be able to help those children and I had, at that stage, no research interest whatsoever in that matter.
Q You are “sign posting”. I am using the words that you used – you mean acting as a sign post to send them in the right direction.
A That is correct, yes.
Q So as far as that is concerned you are telling the Panel, are you, that when parents rang you up you felt that it was your duty to tell them that they should go to their GP and get a referral to a clinician – your duty either as a decent human being or as a doctor?
A The decision was deferred clearly to the general practitioner but my recommendation was that if they felt it appropriate – and many of them had actually asked me for a referral – then they should seek approval and referral from their doctor if he felt it was appropriate.
Q So that is your sign posting role. Other than that sign posting role are we to understand that your involvement with these children arose exclusively from the pursuit of your research interests?
A Certainly in the latter part of 1995 the answer is that the research interest assumed a greater priority because the coherence of the story presented by the parents suggested that there may be some interaction between the bowel and the brain that may be important in their disease and that this may be accessible to further understanding through research, and amelioration.
Q So that apart from your sign posting role in referral, which you have described to us, all your other involvement with these children arose exclusively from your research interests.
A I would broaden it to say clinical concern, and that was implicit in the signposting role, and research, yes.
Q We will revert to that when we look at the individual children, doctor. I now just want to ask you a few much more general questions in relation to some of the personalities that you have been telling us about just so that I can be clear as a matter of background what you say their roles were. First of all, can I just ask you about your work colleagues? We have seen reference to your secretary; did you have a full time secretary?
A No, I shared a secretary with Dr Andrew Burroughs, who was a liver transplant physician.
Q You told us that you had an office and a lab although, as I understand it, that moved floors during the course of your employment, is that correct?
A The office moved floors. I had two laboratories, one in histopathology and one in medicine.
Q We know – because we have seen it in your job description – that you had various researchers working under your supervision; is that correct?
A Correct, yes.
Q What about the research nurse that we have heard mention of, Jill Thomas, what stage in all this did she arrive, roughly?
A I am afraid I do not know; I think it will have been fairly early on in the process but I simply do not remember, I am afraid.
Q What was her role exactly, can you explain?
A She had two roles: one, which is not relevant to the proceedings, is she was involved in establishing the first national register of paediatric inflammatory bowel disease, Chron’s and colitis; and the second role was to act as a … Let me step back. It was clear to us that the children put high demands on the clinical service. The parents had many, many questions; they required a lot of help, a lot of reassurance and in a busy paediatric gastroenterology unit there was no one really dedicated to deal with this new influx of patients, and ideally what was required was an individual who could act as a liaison, a sounding board for the parents and someone who could interact with the laboratory staff and with the clinical staff in coordinating the care of the children and making sure that things got done, that the parents’ questions were answered or at least referred to the right quarters. That broadly was her role.
Q Who employed her?
A I raised the funding for her and I think the Medical School employed her.
Q She was a research nurse, is that correct?
A Yes, she was appointed as a research nurse.
Q Professor Revell was the Professor of histopathology and whilst you were in that department I think you told us – and he was obviously head of the department – you had some contact with him but your research interests were very different, his was in bone and joint; is that correct?
A That is correct.
Q Professor Pounder, who you mentioned on a number of occasions as your direct line manager, was a gastroenterologist, is that correct?
A Yes, he was an academic gastroenterologist.
Q With very considerable research interests in common with your own.
A That is correct.
Q You say he was an academic but he had a clinical practice as well?
A He did.
Q In adult gastroenterology.
A Yes.
Q And he was someone you got on well with?
A Very well.
Q Would it be fair to describe him as a friend?
A Yes.
Q Was he a hands-on kind of line manager, the sort who knew what was going on in his department?
A Very much so, yes.
Q Dr Linnell – and there is no magic about the people I am picking out,
Dr Wakefield, but they are people who I think we are not absolutely clear about what their role was – we know was one of the co-authors on The Lancet paper ultimately. He is part, we know, of the IBD study group in the University Department of Medicine, is that correct?
A Yes. By way of clarification could I just go back to Professor Pounder? Professor Pounder’s specific interests were adult Chron's disease and colitis and our interactions were almost exclusively in those areas. As the work on the children with autism and bowel disease evolved then he was not involved in that, other than peripherally. Dr Linnell is a recognised world expert in vitamin B12 metabolism and its various abnormalities and Dr Linnell came to us on a one day a week basis from the Vitamin B12 Unit at the Chelsea and Westminster Hospital.
Q And he was a researcher?
A He ran a clinical service at the Chelsea and Westminster and he ran a series of clinical tests involving analysis of vitamin B12 and its metabolites and at the Royal Free he provided that same service to these children in terms of the methylmalonic acid analysis, and he also intended to provide a research element to that, which was the measurement of cobalomin coenzymes, more esoteric tests that in fact ultimately were not undertaken.
Q Who was he employed by?
A He was employed by the children’s charity; he was funded by the children’s charity and I think he had a one day a week appointment with the medical school.
Q He was funded by a children’s charity on a research project?
A It had research and clinical elements to it.
Q Professor Walker-Smith, you have told us you rated him very highly indeed,
I think were your words, as a paediatric gastroenterologist, is that true?
A That is absolutely correct.
Q And likewise Professor Murch?
A Sorry, yes.
Q And as far as they are both concerned, they had, you say, distinguished research careers. Is that correct?
A Correct.
Q So you valued them, you rated them if you like, for their research and for their clinical medicine?
A Yes, indeed.
Q It has to be remembered that they too had academic appointments and carried out research?
A Yes.
Q The only difference between them and you is that you were a pure researcher, and they had honorary clinical contracts which entailed very extensive clinical management ---?
A Yes.
Q --- in the true sense of the word of patients?
A Yes.
Q Mr Miller suggested, when he was asking Dr Casson questions, that they – Professor Walker-Smith and, I think by implication, Professor Murch – had a reputation for having a culture of energetic investigation? Was that a reputation that you were aware of?
A Yes. If I might explain to the Panel, and Professor Walker-Smith can speak to this, there was a period in paediatric gastroenterology in the arena of coeliac disease where there was considerable debate about whether children with possible coeliac disease should undergo small bowel biopsy. Professor Walker-Smith was an advocate and others were not. Professor Walker-Smith prevailed, and was deemed to be correct, and it is now routine. So he came with the experience of having been involved in what was a controversial area and having prevailed and to that extent, yes, there was a threshold for investigation of children which was perhaps historically lower than others that turned out to be correct.
Q Were you aware of that before he came to the Royal Free?
A Yes, I was.
Q I do not suggest, and I do not think that you were, given the magnitude of what was involved, that Professor Walker-Smith’s employment at the Royal Free lay in your gift, but as I understand it you are telling us that you played some part, you were instrumental, if you like, to some degree, in his move to the Royal Free?
A Yes, I was.
Q You telephoned him, you have told us, direct around Christmas 1994, to suggest it, in effect?
A To ask him if he might consider the possibility, given the pending closure of Barts and Hackney Children’s Hospital which, in the event – I think Barts certainly did not close. Hackney Children’s Hospital, I do not know.
Q And you foresaw a fruitful collaboration with him. Would that be fair, if he were to move to the Royal Free?
A Certainly in my discussions with him such a collaboration was not explicitly or implicitly a condition of his transfer, or my offer. That would have been entirely inappropriate. Nonetheless, yes, it would have been an opportunity to work together with one of the founding fathers of paediatric gastroenterology.
Q Prior to Professor Walker-Smith’s arrival, there was no designated paediatric gastroenterology department at the Royal Free. Is that correct?
A Correct.
Q So that although no doubt there were many paediatric referrals, there was no tradition, if you like, of tertiary referral for paediatric gastroenterology?
A Correct.
Q And from your point of view, the advent of Professor Walker-Smith’s department brought with it – the department – some potential, if you like, for research into paediatric gastroenterology?
A Yes, it did. Again, I emphasise that that was not in any way a pre-condition that I had set for him considering the possibility of moving. It is possible, as you will be aware from the structure of the inflammatory bowel disease study group, to collaborate with colleagues around the world in different disciplines. There was no need for Professor Walker-Smith to be at the Royal Free. Nonetheless, it would have provided that opportunity if, following transfer, Professor Walker-Smith wished to collaborate.
Q Two other people that I want to ask you about, Dr Wakefield, and they are not, of course, related to the hospital. One of them is Mr Richard Barr. You have told us how you first met and agreed to act as an expert in the litigation, and we will be looking at that in a great deal more detail, of course. But your view of him when you had that interview with him, and he told you what his litigation was about, and asked you whether you would act as an expert – what was it? Did you think that he was a knowledgeable professional?
A The medical profession has a natural fear, perhaps, of the legal profession and becoming involved. What struck me when I met Richard Barr, and Kirsten Limb, his associate, was that in fact they had a deep knowledge of the subject, and that they were motivated very much by their concern – their genuine concern – for the children. This was manifest, later on for example, in their seeking to prevail upon the Medicines Control Agency to examine their files in great detail, to make them aware of a potential problem; to attend a meeting with Tessa Jowell, to bring her attention to the problem. They were not in any shape, manner or form ambulance chasers, and I would not have become involved if they were; but they had a genuine concern for the well-being of these children.
Q Just to revert to the more specific question that I asked you, Mr Barr seemed to you to be a serious professional, who knew what he was doing as far as his own job was concerned – as far as you could tell?
A As far as my limited experience of lawyers at that time was concerned, yes.
Q Lastly, Kirsten Limb – she was the scientific investigator at Dawbarns. I make it clear, I am only asking you the next question because it may be relevant to things I have to ask you later about where documents have come from, not because I have any interest in their personal lives, but she is in fact also Mrs Barr?
A Correct.
Q I want to turn on, if I may, to ask you some very general questions about research work, Dr Wakefield, and you tell me – or rather tell the Panel – if I getting this wrong. In broad terms, as a researcher you are going to begin with an inspiration, if you like, an idea – is that right – which you formulate into a scientific hypothesis?
A Precisely that, yes. When I was in Canada, I had no intention of conducting research. My only interest was in operative surgery, but discoveries, albeit rather minor, that I made with my colleagues in Toronto I found very exciting, very challenging. It stimulated me to become more and more involved. We were, if you like, in small bowel transplantation, dealing with an end point which might benefit a handful of people in the world, and yet we were dealing with diseases such as Crohn's and colitis which have a lifetime risk of 1 in 140 or more, and yet we did not understand the origins of those diseases. So it seemed to me that it was likely to be far more productive to go back to the origins rather than dealing with the end point.
Q Having begun with your inspiration, your idea, you formulate your hypothesis, and after that you have to descend, to you not, to the pragmatics of designing a study which tests the hypothesis, and worrying about who is going to fund it and whether you can get ethical approval for it. Would that be correct?
A Broadly, yes.
Q And as far as the funding is concerned, we have heard this evidence already, I think. In truth I cannot remember – I think it was Mr Else who told us – there is a research and development pot, if you like, in hospitals which is for NHS-funded research, and is a very small pot, and most research involves going out and finding external funding?
A Yes. At the time I was not aware of the research development pot at all. It is not a resource I had ever accessed, so my funding was exclusively external funding.
Q That structure – having your idea, formulating your hypothesis, designing your study, finding the funding, getting ethical approval for it – was the structure in which you had been operating, obviously with varying levels of seniority since you left clinical medicine, surgery, and went into research?
A Yes. I had been operating under the wing, if you like, of Professor Pounder who was leading the Crohn's and colitis research, really up to the point that we started the research on the autistic bowel disease and then our paths devolved to some extent.
Q When you say you were operating under his wing, Dr Wakefield, you were in fact the Research Director of the Inflammatory Bowel Disease Study Group, charged with obtaining a worldwide reputation for it, as we have seen from your job description. Is that correct?
A Charged by myself, I have to say. Yes. And Roy Pounder was an integral part of that Inflammatory Bowel Disease Study Group. We were working together to achieve that aim.
Q Of which you were the Research Director?
A That is correct.
Q If you are a doctor – and this is an entirely general question – working as a researcher on human subjects, with human subjects involved, if you like, in your research, I think that you would accept that you have a responsibility to ensure that your research is ethically conducted?
A Yes, I think that is absolutely right, to the extent that within, for example, a collaborative programme that word “ensure” entails you relying upon the input of your expert colleagues in their areas of particular expertise, and if they say that something is ethical and appropriate, or clinically indicated, or covered adequately by research approvals, then you are in a position where you can make a judgment whether to take that on faith or not.
Q Doctor, I did say to you, I am asking you a general question. I am quite happy to put it in even more simple terms if it makes it easier for you. I am not interested in what other people were doing. I am asking you whether you – you as a doctor – involved in research, which in turn involved human subjects, had to be comfortable, ethically, with what you were doing. You had a responsibility to be comfortable with it?
A Yes. There is a different between being comfortable and ensuring. One takes all reasonable precautions in dealing with one’s collaborative colleagues to make sure that everything is being conducted ethically.
Q That is not just a question of complying with what a research ethics committee requires; it is identifying in your own mind, is it not, the ethical issues which might arise from your research?
A Yes. Clearly with the guidance of one’s senior colleagues and the ethical committee itself.
Q And of course, ethical committee approval for any research that you wanted to undertake in your capacity at the Royal Free required ethical committee approval? It was mandatory?
A With one caveat, and that is, as we have heard, prior to the Tissue Act, and I think that Professor Revell was very clear on this, that particularly in the area of histopathology, but in other areas as well, it was perfectly reasonable to access archival samples, tissues, samples taken from patients, and that provided that they were anonymised to investigate, to conduct research using those samples and to publish that research, and that at the time did not require either reversion to the individual for approval or ethics committee approval as I understand it. That situation clearly changed with the enactment of the Tissue Act.
Q I am going to look a little more closely at your understanding of research ethics approvals and when they are needed in a moment, Dr Wakefield, but can I ask you this? In broad terms, will you tell this Panel what you understood the reason why researchers have to go to research ethics committees for approval – in general terms. Why do they exist?
A When research was to be undertaken prospectively on NHS patients, then clearly for the protection of those patients approval was required.
Q In your years as a researcher, prior to 1996 and the study you were involved with in relation to the Lancet children, making applications to research ethics committees was something that you were involved with on a very frequent basis. Would that be correct?
A No. In fact they were all under the umbrella of Professor Roy Pounder’s control. He had made the applications up to that point. My first application was 172/96. Prior to that I had been peripherally involved in offering advice but I had had no role in the completion of any forms or any interaction with the ethics committee at all.
Q I put the question to you very specifically, Dr Wakefield, and I am aware that your evidence is that the 172/96 was the first application that you had made, and that before that Professor Pounder, you tell us, had made them and you had contributed to them. That is why I said to you making applications was something in which you had been involved in on a frequent basis – not the actual filling in the form, but the awareness that an application had to be made and providing information which was to be included in it?
A Yes. I think my only issue, Ms Smith, was with the word “frequently”. I had not been involved frequently.
Q We have a very long list. I was not proposing to go to it but I am pleased to do so if it assists anyone. Again, I am not suggesting that you were solely involved with these applications, but certainly your name appears on them. It is FTP3, 1223. As I say, I was not proposing to go through these, Dr Wakefield, and the reason I was not is because they are in a very confused order, I entirely accept, with start dates and end dates all over the place, but they involved – which is the question I asked you – a great many projects where your name would have appeared on the ethics committee application. Would that be fair?
A Which page are we?
Q You can go through every page. I happen to have your name highlighted, but you can see it yourself. If you want me to go through them all with you, I will, but I wonder if it is terribly helpful. The only question I am asking you is whether your name appeared on many ethics committee applications?
A I think – and I may have misunderstood – that the issue was prior to the submission of 172/96. Prior to that ---
Q Yes. Go on.
A --- I was involved to my knowledge in not many, and certainly not a frequent number.
Q Look at page 1225. First project 1994; second 1994; third 1995; 1995; 1991; 1993; 1993; 1995; 1994; 1995. Those are the start dates. They all ended a lot later. We see your name appearing, I think I am right in saying – I do not want to be unfair to you – in every one of those.
A As I have said in evidence, I was involved ---
Q Yes.
A --- with Professor Pounder.
Q Thank you. You can put FTP3 away now. Please get out, if you would, FTP4. You were asked about some of these guidelines and your awareness of the various ethics guidelines, by Mr Coonan, and you were taken by Mr Coonan to tab 3. That is the Royal College of Physicians’ report on research involving patients. It is dated January 1990. You told Mr Coonan that you were aware of its existence because, you said:
“A … my guidance in matters of ethics and clinical research came from Professor Roy Pounder who was a Fellow of the Royal College of Physicians. We will have referred to elements of this document; I certainly have not read it all at any stage, but we will have referred to specific elements of it in the design of particular studies or when particular questions arose.”
For anyone who wants it, that is Day 48/24.
Is that the position?
A Yes, it is.
Q So your contribution to ethics committee applications prior to 172/96 have indeed involved discussion of these matters, at least in general terms, referring to elements of this document and to specific elements of it when you were designing studies, is that right?
A When designing clinical studies, yes.
Q As I understand it, you are making the point there that Professor Pounder would have been a member of the Royal College of Physicians, as opposed to Surgeons, so this would have been a document that he would have had access to, is that correct?
A This document was available in his laboratory, yes.
Q Then you were asked about tabs 4 and 5, tab 4 is guidelines on the practice of ethics committee, just so you know where they are …
A Yes.
Q Tab 5 is “Local Research Ethics Committees”. You said about those that you could not specifically remember, is that correct?
A That is correct.
Q Indeed, those documents deal with matters which perhaps a committee member rather than a researcher would be referring to?
A They may well do I ---
Q You do not know that?
A --- have not read them.
Q Then tab 8, which Mr Coonan asked you to look at, and you said the same answer applied, by which I understand you to mean that you did not have any specific recollection of them?
A I do not remember this document, no.
Q What you were not asked about were a number of the other guidelines, and I do want to ask you about two particular subjects, Dr Wakefield, but, first of all, I do want to make my position clear to you and the Panel on this. I am not suggesting that you or any other doctor should be able to recite great tracts of ethics guidelines, but what I am suggesting to you is that you do have a duty as a doctor involved exclusively in research medicine to understand the basic ethical framework in which you operate: would you accept that?
A Yes, I think that is a reasonable point.
Q You were not asked by Mr Coonan about guidelines relating to two particular categories, one was to healthy volunteers and one to do with those relating to children, and I want to ask you about those. You have told us in the context of telling us about the birthday party incident, and I am not going into the facts of that at this stage, I will revert to that, but you told us in that context that your understanding – and you said: “… I appreciate that this may well have been imperfect – was that ethical committees …” did not extend to children who were not NHS patients.
A My understanding, as I think I said in several answers, is that my belief is that the ethics committee and its guidelines were there to adjudicate, if you like, upon research conducted on NHS patients.
Q You said that you appreciated that the understanding might be imperfect.
A I have come to that understanding as a consequence of these proceedings, yes.
Q It is wrong, is it not, doctor, it is not imperfect, it is wrong?
A Yes, it is.
Q Are you really telling this Panel that you thought that you could do, as your personal conscience dictated, research on children, provided they were not NHS patients, without any constraints on you at all, is that what you are telling us?
A The concern that I had was of fully informed parental consent and agreement of the child specifically in the context of that birthday party. It seems to me extraordinarily counter-intuitive that someone possessed of the knowledge that it was indeed in breach of ethics approval would get up at a lecture and tell the story. I am perfectly willing to accept that my understanding was wrong but I genuinely did not believe that I was in contravention of ethics approval.
Q But you have accepted that you had a duty as a doctor involved exclusively in research medicine to understand the basic ethical frameworks in which you operated.
A And that is correct, and for those purposes one’s instruction came not only from the first document that you referred to but also from the guidelines available from the ethics committee that were attended (?) to the applications and from one’s senior colleagues who had a great deal more experience in this area.
Q Before I go on to ask you about those particular guidelines and how they relate to children, I would like to ask you to turn to tab 2 in FTP4. This is a report, again from the Royal College of Physicians, from way back in 1986, “Research on Healthy Volunteers”. Again, I am not suggesting that you should have known every word of those guidelines but are you really saying that you were wholly unaware of the role of ethics committees in research on non-patients.
A On …
Q On non-patients, those who were not under the NHS?
A Yes, I explained, and I hope I have made clear what my understanding was to the Panel and it was that ethics committees were there for the protection of the rights and wellbeing of NHS patients involved in research.
Q Let us turn to the guidelines on research on children who are patients: you have told us you had a broad idea of the ethical guidelines, in the same volume at tab 4, so let us turn back to that one, and go to page 111, please, these are 1990 college guidelines, “Special classes of research” and this is the section on research involving children, doctor. I am not going to go through it all but it is apparent that it is quite complex, is it not?
A I have not read this, I am afraid.
Q The whole issue of research involving children as opposed to adults, I think you would appreciate, is probably a more complex subject, would that be fair?
A Certainly from the changing profile of what was happening at the time, and according to Professor Sir David Hull’s evidence, yes, that is the case.
Q We see in it at 13.2:
“The particular problems relating to research involving children have been the subject of several reports and a book. The British Paediatric Association published guidelines in 1980 and has a Standing Ethics Advisory Committee which will respond to requests for advice from individuals or from Ethics Committees …”
It then goes on to the fact that non-therapeutic research and the risks it entailed, so you had a broad idea, if you consulted that. Were you aware at all of the detailed guidance provided by the British Paediatric Association?
A Not at all. Any references to documentation had occurred previous in the context of studies undertaken with Professor Pounder and in guidance on the ethics of research on children. Professor Walker-Smith was clearly an expert in this field.
Q We will come on to that in a moment, if we can just look at the guidelines from the British Paediatric Association just so the Panel know what you did not look at, they are at tab 7, “Guidance for the Ethical Conduct of Medical Research Involving Children” and we see the document ensuing. One of the reasons why documents of this kind from the British Paediatric Association would not have come across your radar, if you like, would be because you have no paediatric qualifications and so you are not a member of that association, is that fair?
A Correct.
Q So exactly the point that you were making in relation to Professor Pounder and the Royal College of Physicians.
A Yes.
Q Prior to 1996 had you been involved at all in any clinical research on children?
A The only think that I have done, I believe, is to publish a case report with my paediatric urology colleague in the Journal of the Royal Society of Medicine, but that does not constitute research and I think the answer is therefore, at least as far as I am aware, no,
I have not.
Q Before embarking on this particular project how did you bone up on the principles involved?
A Going back to the latter part of 1995 and right through 1996 there were extensive discussions with colleagues expert in the field, particularly Professor Walker-Smith, Dr Murch and others, about the various investigations that were to be performed on these children, their clinical merits, the investigations that I would be conducting in a research setting and the ethical elements of all of these were considered in detail.
Q But if you had not read up the basic principles how could you understand what you could or could not do or what you could or could not do without reference to particular principles? Are you saying you relied entirely on Professor Walker-Smith and Professor Murch?
A Yes, the answer is very simple, that one relies upon the input of those who are fully conversant with those guidelines.
Q Doctor, that may be the case if you were talking about a completely different specialism but you were a researcher – you, you tell us – and you have been at great pains to underline that Professor Walker-Smith and Professor Murch were only conducting clinical medicine, you, the researcher, intended to embark on research involving children, so you do not say that you are entirely reliant on what Professor Walker-Smith tells you and it is all his fault do you?
A If we are talking about the work that I conducted in respect of the children who were patients then that was essentially biopsy based research or research intended to be undertaken on samples that were procured during the routine procedure, and as such, above and beyond the procedure itself, there were no ethical implications that were not covered or address in the design of the study.
Q Still behind tab 7, the BPA guidelines which you say you were not aware of, page 182, point 2:
“Children are not small adults; they have an additional, unique set of interests.”
Would you accept that?
A It is a little enigmatic. I mean, it does not describe what those additional “unique” set of interests are.
Q And you are incapable of understanding what it means, Dr Wakefield?
A I hope not. I can place my own interpretation on it; that they must be considered in their own right.
Q At the top of page 184 it reads:
“… unique as a research group for many reasons.”
It deals with the consent procedures and how that can be undertaken by other individuals than themselves:
“Many children are vulnerable, easily bewildered and frightened, and unable to express their needs or defend their interests.”
Would you accept that they have that particular vulnerability that needs to be protected?
A Yes, I would and I would say that pertains particularly to the experience with children with autism.
Q Yes, you anticipate my next question, which is that the children that you became involved with were not just any children, were they, they were profoundly disturbed, some were toddlers, and they were going to undergo – and I am not embarking on whether it was research or clinical medicine at the moment – on any reckoning intensive investigation, would that be fair?
A They were a group of children who, because of their extremely difficult presentation, had caused some bewilderment amongst the medical profession to the extent that many of their organic symptoms had been assumed to be of psychological or psychiatric origin, wrongly, and that what they were in fact manifesting were signs of distress and pain.
Q Wrongly in your view, Dr Wakefield, is that true?
A Wrongly in the view of those who looked after them. Wrongly in the view of the parents who had sought to get help because intuitively, instinctively they knew that their children were suffering and in pain, and reinforced by the fact that when the children’s disease was treated appropriately by the clinicians it led to amelioration of many of those behaviour aspects that had hitherto been interpreted as just psychological or psychiatric manifestations of autism.
Q Were you aware of the absolutely fundamental position prior to Dr Pegg sending the actual extract in his letter to Professor Walker-Smith of the fundamental position that if research is of no therapeutic benefit it can be of no more than minimal risk: were you aware of that proposition?
A Not in those specific terms, no.
Q That would be understandably – and I do not mean this in any way pejoratively – inhibiting to those who wish to embark on research, is it not, that particular restriction in relation to children?
A That is neither here nor there.
Q That is not what I asked you. I said was it inhibiting as a general proposition to research?
A It depends upon the question that the research was designed to answer. I am sorry if I have misunderstood the context of the question, Ms Smith.
Q That issue was not something that had had to trouble you at all when you were involved in clinical research on consenting adults, was it?
A On the contrary, the research that I was conducting rarely if ever strayed into that area unless it involved pharmacological intervention and that is subject to its own set of guidelines in which Professor Pounder was expert. The great majority of my research was undertaken on samples removed at surgery or during procedures that entailed no further risk to the patient.
Q Perhaps I can just take you up on that, Dr Wakefield, because in order for you to get the tissue they have to be removed by a procedure, do they not, and it is frequently the case, as we know, and as you have told us all about, extra tissue is removed for research purposes, perfectly properly, during a standard clinical procedure; there is nothing odd about that.
A According to and under the jurisdiction of ethical approval, yes.
Q So to say it does not involve risk is not correct, is it? Again, I suggest it betrays a complete lack of understanding of the research ethics principles. It is not correct because it does involve a risk; if you take an extra piece of tissue then it involves an extra risk, depending where it comes from – perforation, bleeding, all the things that we have to think about, is that not correct? It does not just arrive in your lab on a plate, it has to be got from somebody.
A The context in which I frame my answer is that provided the procurement of such biopsies is covered by the appropriate ethical approval and is being taken according to standard procedures by people expert in those procedures then what I am doing is constrained appropriately and guided by entirely reasonable ethical practice.
Q Why do you think that the consent has to be taken from the individual who is undergoing a clinical procedure? Why do you think consent has to be taken for extra samples?
A Because it is over and above what is routinely taken ---
Q And there is a risk.
A … and I agree that there is an additional risk in taking them.
Q This question of the consent of the patient, it is a whole new other dimension, is it not, Dr Wakefield, the vexed question of how a clinician, who is a paediatrician deals with the child who is his patient and with the parent who nine times out ten
I think we all agree is loving, responsible, often absolutely desperate. That is a difficult dilemma for a treating doctor, would you accept?
A I am sorry, Ms Smith, if you could frame the question again.
Q I said the whole question of how a treating clinician deals with the child who is his patient and with the parent who may be having to be consented for the procedures, who I think we all agree is going to be nine times out of ten loving, responsible, often absolutely desperate with fear and worry, that is a difficult situation for a treating doctor to have to deal with. Would you accept that?
A It certainly can be, yes.
Q And it is one in which you have no training and extremely limited experience, would that be fair?
A Let me take you back to my early training. Surgery and general surgery in particular does not discriminate between paediatrics and adults in the general hospital environment. For example, at Frimley Park Hospital on some nights I would take out six appendixes. The parents of those children who were undergoing appendectomy were as you described them – concerned, desperately worried, prospect of an anaesthetic or ruptured appendix and a lot of my work was spent in those very, very busy clinical environments talking to such parents, so I had considerable experience in that area. And I also happen to believe that the interaction with the parent, the understanding of the narrative of their story is absolutely essential not only to establishing the origins of their child’s problem but also establishing a trusting relationship with the parent.
Q Do you also accept that in the end the child is the patient?
A Absolutely.
Q Turning away from your experiences in 1986 of taking out appendixes,
Dr Wakefield, in your later years if it came to issues relating to how to consent parents for a study of this kind, whether it involves some or all research, is not a subject in which you had a great deal of experience.
A And indeed is something in which I was not involved.
MS SMITH: We will see about that when we look at the drafting of the consent forms. Sir, I see it is nearly 11 and I am turning on to another subject, so I wonder whether that might be the moment to break.
THE CHAIRMAN: I think it would be appropriate to adjourn now. Dr Wakefield, in addition to what Ms Smith said earlier, that if any stage you do feel that you are starting to feel distressed – and it is very stressful anyway – and that you wish to have a slight interlude then provided it is within limits the Panel will be very sympathetic to your request. It is 11 o’clock and we will resume at 20 past 11. To remind you once again, Dr Wakefield, you are still under oath and in the middle of giving your evidence.
(The Panel adjourned for a short time)
MS SMITH: Dr Wakefield, I want to turn on to another topic and that also is one that Mr Coonan dealt with at an early stage in your evidence, which is basically how your research interests grew. I will only go into it briefly because you clearly explained the genesis and identified, the Panel will remember, various seminal papers along the way on your CV, and that started – just as a very quick recap, and I appreciate that this is a thumbnail – with a paper in 1989 which was looking at the pathogen of Chron's disease, is that disease?
A Correct, yes.
Q And you have told us that the part that was played was the identification of blood vessel injury which might be instrumental in the development of Chron's disease and a new way of looking at how it began.
A That is correct.
Q You then looked at infections which might have caused the damage to the blood vessels.
A Yes.
Q And that led ultimately to the publication you have told us about in 1993 in the Journal of Medical Virology, which is the one which looked at whether that infection could be measles virus.
A Correct.
Q I know I am skipping steps along the way but ultimately in 1995 you came to a paper which made, in your contention, an association between Chron's disease and measles vaccination as opposed to wild or natural measles.
A Yes.
Q That of course, I think you will accept, was an important distinction because it inevitably has major implications as to the desirability of the vaccination.
A It certainly raised a question, yes.
Q And it did raise a question, did it not, and caused something of a stir, that 1995 paper, Is measles vaccination a risk factor for IBD?
A Yes.
Q Whether or not you were right or wrong, Dr Wakefield, plainly we will agree it is not the place for that to be debated, but I think that you will agree with me that some researchers disagreed with both your theory as to the vascular pathogenesis origin of Chron’s and as to the association you made with measles vaccine.
A As in the nature of science, yes, indeed, they did.
Q There was an early meeting to which I will revert in a moment that was in January 1995 with the Department of Health where another scientist was putting forward another theory as to the cause of Chron’s and where a scientist also called into question the quality of your paper making the association with vaccination.
A Correct.
Q We have heard a bit about it now but just so that we are clear about the terms, vaccination is a complex subject, would that be fair?
A Extremely complex.
Q And very broadly it involves looking at virology, where the virus is coming from, immunology, how the body reacts in fighting that virus, and epidemiology, which is the study of how disease spreads across populations. Is that a fair lay description?
A Yes, vaccination can be divided into prophylactic vaccination or therapeutic vaccination and within those separate domains one can examine the concept of vaccination in terms of its safety, its effects at the population level – epidemiology, as you say – the virological aspects and indeed the immunological aspects.
Q I think I am correct in saying that you have no formal qualifications in virology, immunology or epidemiology?
A Correct.
Q Around 1995 we have the extension of your hypothesis – obviously late 1995, early 1996, to the connection between gastro and intestinal disease and behavioural disorders.
A Starting early in 1995, yes.
Q That began, would it be fair, with a strong suspicion on your part that vaccines might be implicated?
A Yes, I had no reason to look at that stage at the MMR vaccine in particular; my interests were in the role of measles vaccine and various patterns of exposure to measles in inflammatory bowel disease.
Q And you had by then some pretty strongly formulated views, did you not?
A My views were that the matter required consideration. I did not have a view that the vaccines caused the diseases but that the matter required urgent investigation.
Q We will have to return to this later but if we can just look, to remind ourselves, your first letter to the Department of Health, which is right back in 1992 in FTP1 at page 12. I am not going to go to the whole of this letter, although I am happy of course that you should refer to anything you want in it. This is a letter you wrote on 2 October 1992 to Dr Salisbury at the Department of Health and you said:
“I am writing to clarify our position with regard to the potential aetiology of inflammatory bowel disease and the role of measles virus. Three years ago we started work on the pathogenesis of Chron's disease.”
And you set out what you thought your work had confirmed. You then go through some of the science behind that, and at the bottom of the page you say:
“Of particular concern to us is the real increase in the incidence of Chron's disease in children over the past 15 to 20 years. When one looks at the rate of uptake of the measles vaccine during this period there is a similar upward trend between these two sets of data.”
So that is a reference, is it not, to the epidemiology that opined the findings that you thought that you had made at that time?
A It is more of a correlation than an epidemiological analysis.
Q It involves though, does it not, the examination of matters that would commonly be under the umbrella, if you like, of epidemiology?
A It is certainly a matter that could be examined using epidemiological methods, yes.
Q And you say:
“The purpose of my phoning you …”
So there had obviously been some previous contact in this letter:
“… was to forewarn you that this will the first question that is raised following publication of the paper.”
In other words, whether Chron's disease was implicated in measles vaccine.
A That is right.
Q “Although this question has not been addressed in the publication itself,
obviously we will need to do this in the very near future.”
So although that early paper did not make a form association you still thought that it was going to raise questions which would have to be answered.
A Yes, certainly amongst colleagues in paediatric gastroenterology who were seeing a large increase in this order, they not unreasonably would pose the question if it is associated with measles virus and it is now appearing in children and going up, then is that because the pattern of exposure, such as vaccination, may be causally implicated.
Q You say:
“My concern is that although measles, and in particular the vaccine may ultimately have no association with Chron's disease whatsoever, what will be picked up by the press is the apparent association between the increasing incidence of disease and the vaccine. Therefore I think it would be imperative for us to meet in the near future to discuss the way forward.”
And you are acknowledging there, are you not, that even if a paper ultimately does not come down in favour of making a firm association the press do not necessarily report it in purely scientific terms, they pick up illusions.
A That is correct, and it comes back to the earlier sentence in that letter where
I have said that the question has not been addressed in the publication but will be in the near future; in other words, the next logical step is to examine the hypothesis as to whether these diseases, Chron’s and colitis, are more common in vaccinated populations than unvaccinated populations, and therefore I felt that in view of our intention to pursue that logical progression and in view of the fact that it may come to the attention of the media but for public health reasons predominantly it would be useful to establish a dialogue with the Department of Health.
Q Not only useful to establish a dialogue, Dr Wakefield, but also to engage them in conversations about funding your research, is that not correct?
A Yes, indeed. It is a matter that I thought would be of particular interest to them.
Q Implicit in that letter was a threat, was there not, in relation to the media interest which might ensure?
A Absolutely not.
Q And as far as your request for funding was concerned, I think you have accepted that the Medical Research Council was the appropriate avenue to go down if you wanted funding, not the Department of Health?
A I sought to raise the issue with Dr Salisbury since I felt he may be interested in pursuing this. He was not and that is where the matter came to rest.
Q We will go on, if we may, to page 17 which is now May 1993, so seven or eight months later. You set out the work that you are concerned with and you say in the third paragraph:
“The most worrying feature … has been a dramatic rise in the incidence of Crohn's disease in children over the last 20 years;”
At the bottom of the page:
“We have now reached a critical phase in our studies and further funding is required urgently. Despite this major advance in our understanding of the pathogenesis of Crohn's disease, the implications of these findings have not been fully appreciated.
Some months ago I wrote to Dr Salisbury of the Department of Health requesting an urgent meeting and he has so far failed to respond in a very positive manner. This is not something that is going to go away, and it is going to cause considerable embarrassment if no action is taken at this stage. There is an over-riding need for confirmation and I would greatly appreciate a meeting with you at your earliest convenience to discuss the research findings further.”
And I should have said this was a letter to Professor Peckham at the Department of Health. Is that correct?
A That is correct.
Q Again, you are pointing out that there is going to be considerable embarrassment and you are asking for funds?
A I am certainly raising these possibilities, and it is a measure of my concern that the meeting initially agreed to or accepted by Dr Salisbury had not materialised and, indeed, it was two years before I managed to get that meeting convened.
Q You had a ---
A It is a measure of the concern that I had in this matter, and it was not in any way an attempt to blackmail the Department of Health, but to bring their attention to what I considered to be an extremely important issue for them.
Q Then if we go on to 1994, page 47, it is again to Dr Salisbury. At the top of the page:
“When I wrote to you I requested a meeting … To my surprise and disappointment your interest in the data was limited, and … we have not had an opportunity to meet. We have recently concluded a 2-year programme” – you say – “of research, designed to confirm the persistence of measles virus in the gut …”.
Then going down to the bottom, you acknowledge the value of measles vaccination and that your own children have been vaccinated. Going down to the bottom of the page:
“I am even more concerned that re-challenge”
and you have explained to us what that means –
“with the same antigen later in life will lead to the onset of Crohn's disease. Although it is too early to have data on this, I fear we face a potential catastrophe in the form of an epidemic of Crohn's disease.
I do not believe the government can continue to ignore our work any longer, and the time has come to resource this work appropriately in order that we can either establish or refute a link, to everyone’s satisfaction. I urge you to consider a proposal to meet and discuss this…”
and you look forward to hearing from them. You sent copies of the letter to the Minister of Health and to the Chief Medical Officer. Is that correct?
A That is correct.
Q And again, that letter was asking for funding?
A Yes. The Panel will be aware that by this stage a re-vaccination programme was intended, and that was of particular concern, given the fact that there had been no studies of the safety of such an exposure, a re-challenge exposure, anywhere at any time in the world. I could not consider that an acceptable situation. It was assumed by the vaccine authorities that re-exposure to a vaccine, other than boosting the immunity, was an entirely innocuous event. One thing I had come to appreciate over the years and had come to have a great deal of respect for was the measles virus. I did not feel that in these circumstances, in the absence of safety studies, that it was allowable, it was permissible, to conduct a re-vaccination programme, and ---
Q Do you think it was --- I am sorry. I thought you had finished. Please?
A Again, to confirm or refute any association required funding.
Q Do you think it was allowable or permissible for the Department of Health to take into account the views of scientists who, as we have discussed, thought that there was another cause?
A The problem that I had at the time is that I had had no communication from Dr Salisbury other than an acknowledgement of my letter, and a concession that a meeting would be advisable. He did not inform me at any stage that he had taken advice from other scientists who had given him an opposing view. So the only information that I had was, “Thank you for your letter. I shall arrange a meeting,” and two years later, no such meeting had been arranged.
Q In fact a meeting, as we have just discussed, did indeed take place with the Department of Health in the January of 1995. Is that correct?
A After the re-vaccination campaign.
Q Yes. You underlined that before, Dr Wakefield. What are you saying? Are you saying the Department of Health should have changed their entire re-vaccination campaign on the basis of your views, even if there were other views expressing contrary causes?
A No, not at all. What I was hoping was that they would at least be in a position, or put themselves in a position, to have considered my views in setting up that campaign. Not only that it might cause them to reconsider, if they felt the science merited it, or to put in place a programme of what is called “active surveillance” of adverse events. Very briefly, the current method for ascertaining adverse events to vaccines relies on passive surveillance; that is, it requires the doctor to make an association between the exposure and the adverse event and report that. It is widely acknowledged that passive surveillance systems pick up less than one per cent of true adverse events, and that clearly is totally inadequate. Active surveillance, on the other hand, requires the doctor to report such events, and doctors are contacted on a regular basis and, for example, following the re-vaccination campaign would be – would have been – regularly contacted to determine whether they had seen any adverse reactions. My concern was not only that it may lead them to re-think the intended re-vaccination campaign based upon an assimilation of the science from my group and others, but also to potentially put in place such a programme.
Q So when you formulated your hypothesis in 1995, extending your work into any possible link with behavioural disorders, you were doing so against a background of something of a campaign in relation to the government, as far as vaccination was concerned. You thought that they should be looking very much more carefully at your work in relation to Crohn's disease and vaccination. Is that fair?
A I felt they should be looking very much more closely at the issue generally. I had ---
Q Sorry?
A I had started to undertake, because of my concerns about the safety issues, a detailed analysis of safety. So my concerns came from two perspectives; not only the possible association of these vaccines with this disease, but also the absence of adequate safety studies. The safety studies themselves had been short – the longest six weeks, the great majority three weeks. Three weeks does not even cover the time that the virus replicated within the body, and measles is known for its propensity to cause delayed consequences. So three weeks’ safety studies really are not adequate, particularly in the detection of something like Crohn's disease which may not occur for several years later.
Q And in your perception, the government were ignoring these concerns. That is your basic position, is it not, at this stage?
A Again, all I had to go on were the responses to my entreaties to Dr Salisbury at that stage and, on that basis, I did not feel it was being paid the due attention it deserved.
Q You had your meeting in 1995, and we have discussed the fact that there were other scientists at that meeting expressing very different views, and may we go on just to remind ourselves of what the government’s position was, or rather the Department of Health’s, if you turn on to page 70, please.
“Although the Royal Free Hospital work suggests a possible link associating measles vaccine as a factor to explain the rise in Crohn's disease, many causes such as other infections, genetic markers and auto-immunity have been implicated by other researchers. Indeed, Crohn's disease was well known long before measles vaccine was developed…”.
They culminate by saying at the bottom,
“The Department of Health has already held a meeting of experts to listen to the Royal Free Hospital and other work on infections that may play a part in Crohn's disease. The Department will/is”
This is obviously a draft –
“commissioning a detailed report from independent experts that will investigate this and other theories about infectious disease being causally linked to Crohn's disease.”
That was the culmination of the 1995 meeting, is that fair?
A I welcome the fact that there was such a meeting, yes.
Q And the culmination of it was that the Department of Health intended to commission a report and that they were acknowledging the fact that you had these views and that other scientists had other views?
A Absolutely.
Q And if we go on, please, to page 83, these are the minutes of Joint Committee on Vaccination, which we have heard about from Dr Salisbury and we see:
“In April a proof of the Lancet article and commentary on the research at the Royal Free Hospital had been seen in the Department.”
That is not the Lancet paper with which we are concerned. That is the 1995 paper. I am very happy if you want to take the Panel to anything in between, but I am only interested in the conclusions, Doctor. At the bottom of the page:
“The Committee agreed that the research was unsound. The report had shown associations first with the natural virus and then with attenuated virus. The epidemiology was questionable and the interpretations were unjustified. Inappropriate control groups had been chosen. There were also flaws in virology as the immuno-gold method, which had been used by the Royal Free, lacked specificity. The Committee noted that very few organisms had not been investigated for the cause of CD [Crohn's disease] but that the only constant in the condition was smoking. The Committee agreed that, following consideration of the report, there was no evidence on which to change current immunisation policy.”
So that was the position as they advised the DoH on the basis of your research at that time. As I say, I am not concerned with whether they were right or wrong, but that is the conclusion they reached, is it not?
A I just, if I may, raise something of an objection in as much that you said earlier we were not going to discuss the science. Now in the record is a discussion of the science from a very much one-sided perspective, and I would be happy to sit here until the end of the year to talk about the science if that were deemed necessary, but I do feel that such a unilateral position, taken by a closed committee and never, in fact, made available to me, but presented here before this Panel is inevitably pejorative. I could take issue with every single point that is raised. I just want to enter into the record that I am somewhat concerned about that.
Q We have heard what you have to say, Dr Wakefield. The point that I am putting to you is the fact – just the fact – is that that was the conclusion of that committee and that filtered through into the policy which was then adopted. That is the only point that I am making.
A And it was a fact that was retained within the committee, not made available to me, and I was not at the time given the opportunity to respond in a scientifically appropriate manner.
Q But you were aware that the Department of Health on the advice of the Joint Committee on Vaccination had this idea that there would be no change in current immunisation policy?
A Yes, I was.
Q When you first began to consider whether vaccine might be responsible or play a part, would be a fair way of putting it I think, in the development of certain behavioural disorders in children, you were seeing it against the background of what you had already learned and believed in relation to the role of vaccination in Crohn's disease. Is that correct?
A My interest was, one, in the relationship or potential relationship between the bowel and the brain irrespective of the exposure, because, as gastroenterologists, neurological changes consequent upon a primary bowel disease were evident to us and had been evident for many years. So there was a biological plausibility to that. The second was the possibility that a measles-containing vaccine or, indeed, measles itself was capable of infecting both the intestine and the brain and that therefore there may be a link through a common infection in those tissues.
Q We discussed the way in which research begins, and I think you accepted with me that it begins with an inspiration or an idea which you then have to formulate into a hypothesis. That inspiration/idea you say began with the arrival, if you like, of Mrs 2 onto your desk in May of 1995?
A Yes.
Q You were asked a few questions, and I just want to be clear about the answer. When is the first time that you actually attended a JABS meeting – “JABS”, the vaccine pressure group?
A I am afraid I do not remember.
Q Roughly?
A I was invited to a conference, to attend a conference. I think that the date of that has been read into the record, but that is my only memory.
Q What, you went to speak at a conference?
A I believe so, yes.
Q Had you attended before you spoke at that conference?
A I am afraid I have no memory.
Q You do not remember at all whether you had contact with JABS before they invited you to that conference to speak?
A Sorry, had contact with or had been involved in a meeting? I believe ---
Q Had contact with, first of all.
A I believe Jackie Fletcher of JABS may have contacted me at some stage.
Q Prior to you being asked to speak at the meeting?
A That will have been the case, yes.
Q Was that before or after your contact with Mrs 2?
A I do not remember.
Q As far as the litigation is concerned, I know you have told us that Mr Barr came to see you in the January, I think you said, of 1996, were you aware of the litigation as a general fact before that time?
A My only memory – my earliest memory is of that meeting. Now, it must have been preceded by a contact in order to arrange the meeting, but, again, I do not remember when that contact will have been.
Q Would you look at page 90 in FTP1? I appreciate this is a document you may not have seen but I just want to ask you this about it: that is the first we have from Dawbarns and it is February 1996, and I will come back to ask you about various things in it later, but it is Newsletter No. 4, so it would appear from that that the litigation had been up and running as far as newsletters were concerned for some time prior to February 1996, and all I want to know from you is whether you have any memory of knowing of it as a fact, the fact that there was litigation, insipient litigation, prior to your meeting with Richard Barr in January 1996?
A I am afraid I can only remember that meeting.
Q As far as Mrs 2 is concerned, your first contact with her was in May 1995, is that correct?
A Yes.
Q I want to look at the chronology from that period onwards, Dr Wakefield, but before
I do so I want to say to you, and, indeed, to the Panel, and I do appreciate you may not accept this, exactly what I am going to be suggesting to you in relation to the quite complicated history of these children and the ethics committee application and the Legal Aid Board and The Lancet paper, and what I am going to be suggesting to you is, first of all, that the children who were written up in The Lancet, the Legal Aid Board study and project 172/96 are all intertwined as part and parcel of the same project which was driven by the new syndrome that you are postulating, in other words disintegrative disorder and enteritis following measles and measles/rubella vaccinations, that they were all part and parcel and driven by the same hypothesis. I will go on and deal with the rest of it but I am breaking it up so that if you wish to say anything you may do so.
A No.
Q Secondly, that the project was a research project on these patients, and, thirdly, that The Lancet paper was writing up 172/96, albeit not all the investigations, and that some of The Lancet children were also in the LAB study. I am sure you will not agree with them but are you clear about the propositions that I am pursuing with you?
A Yes.
Q I am going to look, first of all, at a fairly broad overview of the chronology of the way in which these things developed, and then I am going to return to the individual subjects: the first runs on immediately from the questions I have just asked you in relation to your relationship with Mrs 2. Mrs 2 was suspicious of MMR being the culprit, if you like, in relation to her child’s condition when she first contacted you, is that correct?
A Yes.
Q I am sorry, I did not hear you.
A Sorry, yes.
Q You have told us, twice in fact, in your evidence that your first contact with her was on 19 May 1995, is that correct?
A That is my belief, yes.
Q It is a very specific date, Dr Wakefield, and you said it twice in your evidence: where did that date come from? How can you be so clear that it was 19 May?
A I confess I do not remember now but I was clearly certain of it and I have no reason to change that.
Q I may be able to help you because when you were asked again you gave the date and Mr Coonan then asked you why you recalled the date and you said having reviewed the correspondence you recalled the date. Can you identify to us what correspondence it was that enabled you these years later to say that it was 19 May when you were first contacted by
Mrs 2?
A I cannot but I would not have given that specific date if I had not had access to it.
Q Do you have correspondence with Mrs 2 which is not before the Panel in the form of the medical records?
A Child 2 was part of the MMR litigation, and as such there were many, many documents produced by Mrs 2 and others as part of that litigation, and it may well be that somewhere in those documents that specific date was mentioned.
Q You were not aware of the involvement in the litigation you told us when you first encountered Mrs 2 ---
A No.
Q --- is that correct?
A These are documents that were brought into the evidence as part of the MMR litigation, which was to occur, clearly, for Mrs 2 or Child 2, much later.
Q Do you mean correspondence with you personally which does not find its way into the medical records?
A Again, I cannot be specific but the date clearly is a memory to me from some source.
Q Is it not the case that prior to the referral to Professor Walker-Smith you had personally met Child 2?
A Sorry, prior to the referral?
Q Prior to the referral to Professor Walker-Smith in 1985 you had personally met Child 2.
A My first contact with Mrs 2 was by telephone. I do not have a memory of meeting with him, except, perhaps, at the outpatient appointment but if I did then, albeit that I have no memory of it, I have no problem with that.
Q What do you mean you have no problem with it?
A She may have come to the Royal Free to meet me. She may have brought her child but I have no memory of that.
Q Are you telling us she may have come to the Royal Free and she may have met with you, with Child 2, prior to the clinical referral to Professor Walker-Smith, is that what you are saying?
A I have no idea whether she did or not. You seem to have produced a document which says that I met with the child.
Q No, I am not producing any document, Dr Wakefield, I am asking you a question.
A Then let me be quite clear: my first telephone contact was with the mother in May, and I believe that to be the 19th, and my only memory of ever meeting this child was at some stage following his referral and attendance at the Royal Free.
Q You would remember, would you not, with Child 2 in particular, and given your clear memory of the precise date on which Mrs 2 contacted you, you would remember if you had seen Child 2. He was the genesis of your research, you have told us.
A One thing that has become evident to me throughout these proceedings, and, indeed, in the four years leading up to them, is that memory is extremely fickle and as a consequence of that, in framing my evidence and my responses to questions I have relied wherever possible upon the documentation, the contemporaneous documentation, and I reiterate that
I have no memory of seeing Mrs 2 or Child 2 prior to their attendance at the Royal Free.
Q If you would look at page 188 of the local hospital records. This is just so the Panel are reminded: “David” we have learned is Dr David Wozencroft and this was a letter that was written in relation to a phone call from Dr Cartmel to Dr Wozencroft, apparently by his secretary, and it says – and this is before referral and when indeed Mrs 2 is requesting a referral:
“… [Mrs 2] phoned to request the same. I asked for details. She wants you to write to:
‘Professor Walker-Smith …’
She says they are waiting to hear form you before they can offer [Child 2] an urgent appointment. She said the other person involved is:
Mr Andrew Wakefield, Senior Lecturer, who knows [Child 2]. He can be contacted on …”
She gives your telephone number.
I wondered where that reference to “knowing [Child 2]” could have come from: can you assist on that at all?
A I cannot. It is not my document and I have no knowledge of it.
Q You said when you apparently thought that I was going to produce a document you said if you had seen Child 2 you had no problem with that, but it would have been curious, would it not, if you had seen this child yourself as a research scientist prior to referral to Professor Walker-Smith?
A On the contrary, Ms Smith, it may well have been, if that happened, which is denied to my certain knowledge, that I saw this child in any clinical context at all, if Mrs 2 had come to me it will have been because she had something to tell me about her theories on, for example, vitamin B12 metabolism. I did not have an outpatients, I had an office in the hospital. I have no memory of her coming but there would have been no formal arrangement, and I am afraid I am able to offer you absolutely no further insight into what this should mean. I did not know Child 2 and only came to know him later, so the statement to the effect that “Dr Wakefield knows [Child 2]” comes, as far as I am concerned, out of nowhere.
THE CHAIRMAN: This is Child 2. If there are any new members of the press in the public gallery please ensure the anonymity of the child is maintained.
MS SMITH: At any rate, what we can see from that document, and I think you will not argue with, is that you suggested to Mrs 2 that she sought a referral to Professor Walker-Smith.
A Yes, I did.
Q That was prior to Professor Walker-Smith’s transfer to the Royal Free, is that correct?
A Correct.
Q And you have told us that Mrs 2 in effect was instrumental in the development of your research hypothesis with regard to the study that was then undertaken?
A Ideas put forward by Mrs 2 with respect to what she felt might be going on, based upon the knowledge of her own son and what was happening to other children.
Q You said when you gave your evidence that it was “fundamental”, “absolutely fundamental”, Day 48/31, to the hypothesis, is that correct?
A As Ms Smith said, fundamental to the genesis of this hypothesis, correct.
Q On the basis of the very simple template, that I think you have agreed in relation to the way research develops, there is your inspiration, if you like, your idea, and once you have formulated that into a hypothesis that hypothesis has to be tested, is that fair?
A Again, the timeframe needs to be characterised somewhat.
Q Yes. That is what I would like to embark upon with you if I may because there seems to be some confusion in relation to that. You are saying, as I understand it, that further parents contacted you after Mrs 2 had contacted you, so we are talking about the middle of 1995, is that right?
A That is correct.
Q None of those referrals, as we can see from your D8 table, actually filter through until the February of 1996 with the referral of Child 3.
A Correct. The situation was that having suggested a referral to Professor Walker-Smith the outcome of that process was awaited. There was absolutely no merit in inundating Professor Walker-Smith with similar referrals until he had at least been able to shed some light on whether Child 2 had a problem or not. I certainly was not in a position, either contractually or pragmatically, to offer these children anything at all, so other than fielding these calls that was all that I could do, and awaited in the meantime the outcome of Professor Walker-Smith’s deliberations. As far as I was concerned, I had done what I could in this matter and that is where the matter stood.
Q I want to be clear about the mechanics of this. You said when you were answering Mr Coonan’s questions that Professor Walker-Smith made the decision to defer referrals (Day 48/31 and 32). When you were answering Mr Miller’s questions, which were yesterday, you said “a decision was made to defer” and you said, “What I would have said”, and in this case you were talking about yourself, “there is nothing planned at the moment; nothing we can do. These need to be deferred. You may wish to make contact in the future.”
A That is correct. Further on during this process, during 1995, a number of these referrals, or a number of these queries were being raised with me, I will have discussed it with Professor Walker-Smith in terms of what to do.
Q When you say that is correct, which is correct? When you were answering
Mr Coonan’s questions you said that Professor Walker-Smith made the decision to defer referrals and I am not clear from your answer to Mr Miller whether you were saying that you would have said, “There is nothing planned at the moment, nothing we can do; these need to be deferred, you may wish to make contact in the future,” whether you are saying that you said that or whether you are saying you handed them on and Professor Walker-Smith said it.
A Again, in the absence of documentation the precise wording eludes me at the.
Q I understand that; I am not asking for precise words.
A But I do remember that there were a number of these calls and that in the absence of a mechanism for dealing with them, certainly at the Royal Free, and in discussion about these cases it is my memory that there was a decision to defer any similar referrals until Professor Walker-Smith had made the transition.
Q So you are saying that after Mrs 2 rang you up you had other parents ringing you up, prior to Professor Walker-Smith arriving at the Royal Free Hospital, and you told Professor Walker-Smith about those and you made a joint decision to defer? He made the decision to defer? You made the decision to defer? Can you just be clear about that, please?
A It was not my decision to make; it would have been Professor Walker-Smith’s decision to make and I certainly will not have talked to him about every single referral because there were so many of them but I may have talked generically about how to handle such children.
Q So having had a conversation generically you then applied it individually, is that right? Are you saying that you said to Professor Walker-Smith, “I am getting inundated with these calls, what shall I say to them as a general proposition?”
A I am afraid I am unable to provide you with the precise conversation that took place; all I can say is that I made no further suggestions of referrals to Professor Walker-Smith while he was at St. Bartholomew’s Hospital.
Q I am not for a moment suggesting, Dr Wakefield, that you can remember the precise wording of conversations and that is not what I am asking you about. What I am anxious to explore with you is upon what basis and by whom was a decision made if these children, as you contend, needed clinical investigation of their gastrointestinal symptoms, who decided to tell them to go away for what was in fact months to await Professor Walker-Smith arriving at the Royal Free? Who decided that that was an appropriate thing to do with children who you have told us you believed needed clinical investigation?
A I am sure that this was something that Professor Walker-Smith and I discussed in light of the volume of these referrals, and the conclusion to my mind that was come to – not by me – was that referral, if that was to be the process, should be deferred until that transfer took place.
Q That is a generic decision, Dr Wakefield. When a parent rang you up and said, “My child has X” and told you of gastrointestinal symptoms are you saying that you then said, “Go away and wait until Professor Walker-Smith arrives at the Royal Free and then we will investigate”; is that what you are saying?
A No, I am not saying that.
Q What exactly are you saying? How could you make an individual judgment?
A Ms Smith, I did not make an individual judgment; I was asked for my opinion by these parents, who asked if I was in a position to provide help for what we thought might be going on and I cannot, at this stage, remember the precise details of that discussion. What I can tell you is that I was not in a position to make a clinical decision and deferred that back to the general practitioners.
Q You cannot defer clinical decisions if you have no ability to make a clinical decision, can you?
A But I am being asked by the parents if they can come and see me, and I am saying that is not my role, and that was what I meant by deferral.
Q Just dealing with the principle, if these children needed investigating, why could they not be referred to Professor Walker-Smith at Bart’s? Why did it matter to the parent and indeed to the child whether they were being seen at Bart’s or the Royal Free?
A In theory it did not matter at all, in as much that Professor Walker-Smith would be able to offer the same clinical investigations on both sites. But it is my memory once again that in discussion with Professor Walker-Smith there was a decision taken that they should not be made to Bart’s, but they should await his transfer.
Q You are saying – and this is important and I am sure you understand why it is important, Dr Wakefield, because it is the beginning of all of this, is it not – that Professor Walker-Smith on a generic basis said to you, “Defer these children until
I arrive at the Royal Free,” or are you saying that he said that to you on an individual basis, in other words you rang him up about each child and told him the symptoms and he said defer.
A I most certainly would not have called him about each child because there were so many; and I do not remember the time at which the discussion took place, but it is my memory that such a discussion did take place in a generic sense.
Q When these many parents rang you up with gastrointestinal symptoms that you took the view warranted referral to a professor of paediatric gastroenterology, how were you in a position to know whether their treatment was urgent or not, or their condition was urgent or not?
A I did not and nor did I know whether they merited referral to a paediatric gastroenterologist. What I say was that, “If you do wish to see someone about this,
I am not that person. The person that your general practitioner needs to make the referral to you to see, in my opinion, is Professor Walker-Smith.”
Q Dr Wakefield, I am sure that Professor Walker-Smith will not mind my saying this, he was not the only paediatric gastroenterologist in the UK, was he?
A That is correct, but it is the case that many of these children had sought referral from their doctors to paediatric gastroenterologists and that had not been forthcoming; there had been a reluctance – and this is part of the problem – on the part of many doctors – to view the symptoms in these children as anything other than toddler diarrhoea. I cannot offer you details on the specifics of any one case but I do remember that something that was of a particular concern to the parents is that they felt the interpretation of the symptoms had not been taken seriously.
Q We will look at the cases that we have and you can show to me where there have been requests for referrals to paediatric gastroenterologists, which have not been taken up, if that is the right expression, by the general practitioners.
A Those may not occur in the records that you have, Ms Smith, because those are the situations, the 12 that we did see initially, where the general practitioner was amenable to making referral. Many, many of the children who called, even though they sought to prevail on their doctor, never came to see Professor Walker-Smith.
Q Can we just revert back to Professor Walker-Smith’s precise location? You agreed with me that the tests that these children ultimately underwent, as far as their gastroenterological symptoms were concerned, they could have undergone just as well with Professor Walker-Smith’s department at Bart’s as they could with his department at the Royal Free, is that correct?
A That is correct.
Q I suggest to you, Dr Wakefield, that what was different about Bart’s and the Royal Free was you, and that in fact the reason you were deferring these referrals was because you wanted a collaboration in which you could investigate your research hypothesis.
A Let me go back just a little bit to say that the parents had made contact with me specifically because I had published with my colleagues on the possible association between an exposure to measles, measles containing vaccine and bowel disease, and they thought that this was highly relevant to their own child’s particular situation. So they wanted to come to the Royal Free. I was most certainly not in a position to help them but Professor Walker-Smith’s transition was pending and if it were the case, as you put it, that I was deferring them because I wanted access to these children, then why would I have not done so in the case of Child 2?
Q Excuse me, Dr Wakefield, but I did not suggest that you wanted access to these children – that was your interpretation of what I said. What I suggested to you was that the difference between Bart’s and the Royal Free, as far as other investigation of these children was concerned, was your role because you have already told the Panel that there was no difference in relation to any clinical investigation that Professor Walker-Smith thought it was appropriate to carry out on these children.
A But he was, none the less, making a transition. If he was going to establish a clinical relationship, clinical records and all the attendant issues that go with assigning a child to a particular hospital and then have to do that all over again when he transferred to the Royal Free, with all the issues that were going on at the time – the administrative issues associated with transfer, plus being the busiest paediatric gastroenterology unit in the country, then that may well be an entirely justifiable reason for deferring such referrals.
Q You are not suggesting that you leave your patients behind and start a new lot when you go to a new hospital, are you? Professor Walker-Smith was bringing a department with him and no doubt a great many patients who he saw as in-patients and out-patients.
A The point I am trying to make is that it would mean a reiteration of the creation of a clinical record on that patient in two separate hospitals. These are administrative issues and had nothing whatsoever to do with what I was or was not able to approve.
Q So you are saying that your decision to defer was administrative, are you? Is that what you are saying?
A No, I am saying that it may well have in part been administrative but that by virtue of the evidence of Child 2 I was not seeking to defer referral of these children;
I was concerned, first and foremost with their clinical well being and that was my reason for my making a referral or for suggesting to Mrs 2, if he felt it appropriate a referral for investigation to Professor Walker-Smith at St. Bartholomew’s.
Q I want to ask you one more question about this and that arises out of the answer that you gave to my penultimate question. You have told us that the parents contacted you because they knew of your research interest into the role that Chron's disease played in vaccination, is that correct?
A That measles vaccination plays in Chron's disease, yes.
Q So they contacted you because they hoped – and there is absolutely nothing wrong with this, and I am not suggesting there is – that you would be able to do research in relation to the condition from which their children suffered; is that fair?
A No, it is not fair. What is fair is to say that first and foremost they were concerned about the unresolved and unresolving gastrointestinal problems in their children which they, in some cases but clearly not all – and that is evidenced by the first 12 children that were seen – had associated with an environmental exposure. The environment exposure, the concern about that was subsidiary to the fact that they, in their opinion, had a child with gastrointestinal problems that had not been resolved, and what they were seeking first and foremost was clinical care for their child.
Q I want to go on, if I may, to ask you about the draft protocol of the clinical and scientific study that came into being and you have told us that that was in draft by the autumn of 1995. I am using the word autumn because you used September in one point and October in another, but around about the autumn, is that correct?
A The date that I have – again, relying entirely on the contemporaneous documentation – is October 1995.
Q You are going by the fact that included in the ethics committee application ultimately there is an information sheet which appears to have the October 1995 draft on it, are you? Because we do not have a protocol with a date on it, do we?
A No, we do not. The protocol itself will have gone through many drafts to that point.
Q Do you accept that the draft that was ultimately submitted to Mr Barr and ended up going to the Legal Aid Board, that draft was substantially the same as the one that you produced by autumn 1995?
A I have no idea at all. What I can say in the absence of the documentation is that the title was very similar and however rudimentary that draft was, that draft protocol, there appears to have been one in existence in October 1995.
Q Yes, because in order to draft the patient information sheet, which we have, which is dated October 1995, you must have done some sort of draft of the overall project, is that fair?
A That is correct but I cannot say to what extent it resembled either what was sent by Mr Barr to the Legal Aid Board or ultimately came to be the working document 17296.
Q We know it resembled it, do we not, because it is testing the same hypothesis; as you said, it is the same title and it is the creation, if you like, of your idea into a formulated study, your hypothesis into a formulated study.
A There certainly will have been elements common to that document and the final document, yes.
Q Professor Walker-Smith transfers from Bart’s to the Royal Free on
1 September 1995, is that correct?
A Correct.
Q And you say that the protocol was drafted by October 1995, a month later at the latest.
A That is the documentary evidence that I have, yes.
Q That is the month before we know that Dr Thomson arrives in November 1995, is that correct?
A I do not have that date to hand but if you say so I have no reason to object.
Q You told us – and indeed it has been put to you by the other counsel – that there was a series of meetings in relation to that protocol after Professor Walker-Smith’s transfer.
A That is correct.
Q But you have also told us that the protocol was a result of the collaboration – and I am on Day 48-43D – after a long, long consideration which started with the first appearance of Child 2 in May 1995.
A That is correct.
Q So you are telling us, are you, that in the early months the work that was put into the protocol, the draft of the protocol was all done by you?
A No, what I will come back to is your point about, if you like, the enlightenment or the discovery, the inspiration. The process of science, as you have correctly said, starts with that inspiration. What it leads to then in addition to listening to Mrs 2 and other parents, is background reading. At this stage there is no draft, there is merely an effort to investigate the background to the various claims, to see what others around the world have done and think and have written; to perhaps annotate those papers with ideas of your own and at some stage those ideas are formulated into a working hypothesis, and during the process – and clearly we have no dates for them – a document comes together that ultimately through discussions is in its draft form, its earliest draft form that we available or a date that we have available for what was the working draft was October 1995. Beyond that it will have undergone probably quite a radical change in order to arrive at what was the final document for submissions.
Q Who had the input into the early draft? Who literally drafted that? I think you accept that you actually did not draft it?
A The actual word processing of the document was me, absolutely, yes.
Q But I am not asking you about that. When I am using the term “drafting” I mean who initially had the formulation of the ideas and put them on paper as a first exercise?
A The hypothesis will have been articulated by me.
Q Because, you see, you told us, Dr Wakefield, that there was no doubt whatsoever that the clinical priorities were first and foremost, and the research was an adjunct?
A That is correct.
Q But in fact you had the primary input into the protocol, did you not?
A That is not quite the same thing. The suggestion of a referral of Child 2 for clinical care to Professor Walker-Smith at Barts clearly establishes as the first event the priority of the clinical well-being of the children. Following on from that, the assimilation of the hypothesis is a secondary consideration and one for which I, in my role as a researcher, was primarily responsible.
Q Let us look at the draft, if we may, that we have which is at page 113 of FTP1. I am sorry, that is the middle of it. Forgive me. It starts at page 104. That is just so you can orientate yourself. If we go on and look at page 113, that sets out the investigations, does it not, that you were envisaging. Page 113?
A Yes.
Q Are you with me?
A These are the investigations that were envisaged by the collaborative team.
Q If we go on to page 114, we see set out there the neuropsychiatric studies by Dr Berelowitz?
A Yes.
Q
“Confirmation and characterisation of disintegrative disorder …”
on particular assessments. And:
“Neurological and neuroradiological studies”
by Dr Harvey.
“Full clinical examination: Magnetic Resonance Imaging (MRI), Lumbar puncture and CSF antibody profile, cytokine measurement, Electroencephalography (EEG) with …. evoked potentials.”
Is that correct?
A That is correct.
Q You see, if this was a draft, it was a pretty well developed draft, was it not, Dr Wakefield?
A By this stage, yes.
Q You have told us in evidence that at the beginning of 1996 through discussions with Professor Walker-Smith’s team, you decided you needed to involve Dr Berelowitz and also Dr Harvey – at the beginning of 1996. Is that correct?
A Yes. I cannot precisely late the time at which either Dr Berelowitz or Dr Harvey were recruited, or their recruitment was sought, to join the team, and if I gave a date of early 1996, then I would just like to point out that that date is uncertain. I simply do not know when that was.
Q And you say that Dr Thomson brought with him from Birmingham Children’s Hospital a protocol on lumbar punctures for neurological disorders and, of course, that is the protocol that we have seen in Child 2’s notes. Dr Thomson, we know, arrived in November 1995?
A Yes. If the expression I used was “brought with him”, he brought our attention to the existence of such a protocol when lumbar punctures were discussed, as they were at length. He subsequently produced that protocol for inclusion, elements of it to be included in the final document.
Q The neurological and the psychiatric assessments, and the provision of a need for lumbar puncture in that connection, all underpinned the very basis of this study, did they not?
A The neurological investigations were considered merited on clinical grounds.
Q I know that is what you say, Dr Wakefield. I understand that, and we will be investigating it, of course, exploring it, but that is not actually what I asked you. I am not asking you whether they were clinical or research; I am simply suggesting to you that whatever you care to call it, they underpinned the basis of the study, which was in children with behavioural disorders?
A They were part of it.
Q You were not going to get very far without them, were you, if you are trying to establish a hypothesis which suggests a link between enteritis and behavioural disorders?
A Well, yes, you may because the principal reason for undertaking the lumbar puncture was to exclude a mitochondrial cytopathy, which may have nothing whatsoever to do with the gastroenterological disorder, or an infection within the brain by measles virus which, again, has nothing whatsoever necessarily to do with a primary gastrointestinal disorder.
Q But both do have a lot to do with a behavioural disorder?
A Potentially, yes.
Q Certainly, whatever the precise dating, we can be absolutely sure that all this was in a draft, the investigations in detail, and the nature of the neuropsychiatric and neurological studies, was in a draft well before the application to the ethics committee?
A Correct.
Q An early copy of that draft was the copy that you gave to Mr Barr and which has fetched up in our bundles at page 104, because that is the copy that Mr Barr ultimately sent to the Legal Aid Board. It is the earliest we have.
A Correct.
Q You have told us in evidence that the primary motivating force of the programme that was devised was to get the child better. I think I should say, that was in the context of Child 2 that I understood you to be saying it applied generally as well?
A The clinical well-being of the children was the first and foremost priority, yes.
Q You said the primary motivating force of the programme devised – Day 50/43 – was to get the child better. That is slightly different, is it not, Dr Wakefield? What you have now said, that there were clinical priorities is slightly different?
A I would imagine that for any doctor the clinical priority is to get their patient better, so I see these being entirely congruent.
Q Did you change your wording, Dr Wakefield, because you were well aware that in the realms of clinical medicine that has to be the motivating force. In other words, the individual interests of the individual patient have to be the motivating force?
A And were at all times in the investigation of these children.
Q I suggest to you that in fact this protocol – and I will take you to the wording of why I am saying this – but as a general proposition this protocol was plainly a research protocol. We will go through that, if we may. First of all, you seem to attach enormous significance to the use of the word “clinical” in the title. “Clinical” does not necessarily denote clinical treatment, does it?
A It may …. (inaudible).
MS SMITH: I am sorry. We cannot hear you when you are so close to the microphone.
THE CHAIRMAN: I think your voice broke up again. Ms Smith, maybe you can find a convenient time to break in the next few minutes.
MS SMITH: If you would like to break now, sir, then perhaps it would be best to break now because the next passage, I can tell you, is all around the relationship in relation to the clinical study and I cannot break it at any more a convenient moment than this.
THE CHAIRMAN: I am just wondering whether you would wish to have the answer to the question that you had just posed because I do not think that any one of us heard it, or the shorthand writer.
MS SMITH: May I deal with that, Dr Wakefield, and then we will break. What I suggested to you, and I will have to ask another question, sir, after this, was that the mere use of the word “clinical” in the title, as we see it on page 104, “Proposed clinical and scientific study” does not necessarily mean clinical treatment?
A No, it does not.
Q It can just as well mean clinical research?
A It can – just as Professor Rutter points out the word “study” can apply equally to clinical or research.
Q You can leave making points about the experts’ evidence to Mr Coonan, Dr Wakefield, and just answer it, if you please, from your own position, which is not, may I say, that of an expert. You have told us, which is far more to the point, that clinical research in your understanding simply means research on patients?
A Yes. Please accept my apologies.
MS SMITH: Thank you. Thank you, sir. That is as convenient a moment as any.
THE CHAIRMAN: Thank you very much indeed. We will now break for lunch. I think maybe we will take an extra three or four minutes for the purpose of Dr Wakefield on this occasion. It is now getting close to ten to one, and we will resume at ten to two.
Can I just raise this question of housekeeping for this afternoon? How are you hoping to run it this afternoon, from the time period point of view?
MS SMITH: I am entirely in the Panel’s hands. If you tell me what time you would like me to stop I will gear it in such a way – give or take five or ten minutes – to that end. I was assuming that you would be wishing to stop around about four o’clock.
THE CHAIRMAN: I think the other thing that we really need to be quite careful about at this stage of the proceedings is actually the witness, who is giving the evidence.
MS SMITH: Of course.
THE CHAIRMAN: And particularly the defendant doctor, who is giving evidence.
MS SMITH: Of course, sir. I absolutely agree.
THE CHAIRMAN: I think maybe that perhaps three sessions of one and a half hours each are probably long enough for a doctor. I am just thinking ---
MS SMITH: About half past three?
THE CHAIRMAN: Between half past three and four, wherever you find it convenient, but maybe closer to three thirty.
MS SMITH: Certainly, sir. I will make sure that that is the case.
THE CHAIRMAN: Thank you. In that case, I think it is now ten to one, and I will say we will resume at two o’clock. I think that will give an extra ten minutes to Dr Wakefield.
(Luncheon adjournment)
THE CHAIRMAN: Good afternoon to you all. Ms Smith, you are in the middle of your cross-examination. May I make a suggestion at this stage? I think, because we are going to go up to 3.30 or thereabouts, maybe we do not have a break and we continue maybe up to 3.20 or 3.25, something like that continuously. First of all, Dr Wakefield, would you find that more acceptable than going through two sessions and staying here until later.
THE WITNESS: That is fine by me.
THE CHAIRMAN: Continue on that basis, Ms Smith.
MS SMITH: Thank you very much, sir. (To the witness) Dr Wakefield, I want to ask you about some of the language that is used in the early draft protocol that we were talking about before the luncheon adjournment. Could you go to page 104 in FTP1, please. Would you just turn on to page 115 which are the practical issues at the bottom of the page. We see the reference to it being a “demanding protocol both for the children and for … clinicians” and that “Due consideration should be given to this when planning the details of the admission.” Then this is the part that I want to ask you about. This is the nearest we get in this document, which I accept is a draft, the aims of the study.
“However, it is essential that we characterise as comprehensively as possible, the pathogenesis of this condition – control of any underlying intestinal immunopathology may open up new therapeutic avenues for the treatment of affected children. Our ability to confirm or exclude a role of measles or measles/rubella vaccine also has major implications for public health.”
That is the language of research, I suggest to you, in every characteristic?
A Yes. I have no particular argument with that statement.
Q We see nowhere in it, do we, any mention of the clinical benefit to the individual child?
A The statement itself does not in any way preclude such a priority.
Q When you say you have no argument with it, it is the only part of this entire protocol in draft which you describe as being a clinical and scientific protocol and to which, as I understand it, you are attaching a meaning of “clinical” as in normal clinical investigations, why is it that the only aims anywhere in that protocol are entirely research aims?
A This comes under a heading of “Practical issues”, it does not come under a heading of “Aims” at all.
Q I accept it comes under a heading which says “Practical issues” but where does that get us? Why do you say that is relevant?
A The title of the section is “Practical issues”.
Q Yes. Take a moment to look through it and see whether you can help us as to whereabouts in this protocol there is any reference to clinical issues, i.e. clinical in the sense of being clinically indicated, of benefit to the individual patient.
A Implicit in this document, for example, is that the identification of intestinal pathology in the children is crucial. Why? Because using standard therapies applied to inflammatory bowel disease then there is the possibility for the individual of clinical benefit. This document should be taken in conjunction with the statements present in the accompanying documents submitted to the ethics committee with respect to the clinical indications for investigation.
Q We will go on and look at exactly what that document says at a later stage, Dr Wakefield, but as far as this document is concerned, which you have told us was the genesis of this study, the beginning if you like, of the way that you were thinking, and you have told us was clinically driven, and the research you have told us was an adjunct ---
A ..(inaudible)..
Q --- and I am suggesting to you that this document is exactly – well, it is not even the other way round, the clinical indications are not even an adjunct, it is plainly research driven.
A I am afraid I disagree entirely. It has been said time and time and time again that the priority for investigation of these children was their clinical condition. It would not – this entire clinical and scientific protocol would not have been undertaken unless that was the case. I am afraid it was as simple as that. It was clinically driven with a research adjunct; there is absolutely no way that this would have been undertaken purely as an exercise in research.
Q Despite that, in the draft protocol that we are looking at, what you say was the most important bit you yourself accept that there is no reference to?
A Did I say it was the most important bit? Sorry, I do not remember that.
Q You said that the clinical indications, the clinical need of the children was the most important aspect and the research was an adjunct. You have agreed with me that the language which is used in the paragraph that I have taken you to is exclusively the language of research. Now, that means that what you say is the most important bit, namely the individual benefit to the child, is not included in a document which you say is clinical (in the sense of being clinically indicated) and as an adjunct a scientific protocol.
A If the Chairman would bear with me just for a moment while I read this, this is not a matter I have considered before this.
Q Please do?
A Let me read it:
“However, it is essential that we characterise as comprehensively as possible, the pathogenesis of this condition – control of any underlying intestinal immunopathology …”
And one can read that as inflammation:
“… may open up new therapeutic avenues for the treatment of affected children.”
That does not, to my mind, exclude the possibility that the individual child, if an immunopathology, an inflammatory bowel disease is found in that child, they might not benefit from the application of standard anti-inflammatory medication.
Q Your reaction when you read those paragraphs was the same as the question that I was putting to you, was it not, namely that this was plainly the language of research. That is not the way you talk when you are talking about the benefit to an individual.
A I do not see that this statement, despite what I said, and not having reviewed this section specifically in this context, I do not see that either this statement makes this the priority for investigating these children, it is merely a statement of relative import. And the other thing is that it does not exclude the possibility of benefit to the individual child.
Q The closest that you could possibly get to that, Dr Wakefield, is that it may open up new therapeutic avenues for the treatment of affected children, namely – a perfectly proper research aim and I am not suggesting otherwise – that you wanted to have a look because your hope was that you could open up new avenues for treating these children. There is nothing wrong with that but I am suggesting to you it is a research aim.
A It may be, but it does not make that the priority of this process. It absolutely does not.
Q So you are saying the research was an adjunct but, nonetheless, that was the only aspect that you felt it was appropriate to define in this document, is that fair?
A I am afraid that the precise thought process that went into this particular statement I can no longer remember. All I can do is say to the Panel that implicit in this, or perhaps contained within this, is the possibility (albeit ambiguous) that there may be benefit for a group collectively by opening up new avenues of treatment or benefit for an individual.
Q I have to suggest that not only is it plainly the language of research but it is plainly the language of non-therapeutic research: in other words, there is no reference to the benefit to the individual, and an aim, however laudable it may be, to look at an individual for the benefit of children in the future is a research aim.
A You are absolutely right when you say this is non-therapeutic research; nor was it ever intended to be therapeutic research. The priority was to investigate these children clinically according to their symptoms so that the individual might be treated, and we find that time and again in the clinical records of the children, so I am entirely in agreement with you. There is no suggestion that this is therapeutic research. The children were investigated on their individual merits and treated by Professor Walker-Smith and his team accordingly.
Q Perhaps we can go on and look at the document you have referred to which is at page 211 in the same bundle. I think we all do understand the position but just so we are absolutely clear about this, this is dated October 1995, which is why I am looking at it now, but in fact it also appears in the ultimate ethics committee application, which we will be at later on, and I think one of the things which you have been quite properly anxious to tell us is how incredibly important the parents are in all this: their understanding; their having people who are sympathetic to them; them knowing exactly what is going on: is that fair?
A That is correct.
Q This information sheet – I think we had better go through it:
“Information to be given to the parents … of patients taking part in the study of enteritis and disintegrative disorder following measles/rubella vaccination”.
We will return to the measles/rubella vaccination in a while:
“A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination.
The Inflammatory Bowel Disease Study Group and the Department of Paediatric Gastroenterology at the Royal Free Hospital have an established record in research into inflammatory disorders of the intestine. This study hopes to add further to our understanding of the possible link between intestinal problems and behavioural disorders in a group of children who may have responded abnormally to measles and/or rubella vaccine.
If you agree to let your child take part in the study, please sign the attached consent form and return it in the enclosed envelope.
Thank you for helping us with this important work.
If you have any questions please contact Dr Wakefield …”
Now, that is information given to the parents which refers to nothing but a research study, is that correct?
A I think it should be taken in conjunction with the handout to guardian/parents seen at page 232, but you are correct in as much that this is a document, imperfect as it is, prepared in a very early draft of this, and it refers to the adjunct research aspect of the protocol and therefore you see my name on it because at the time I felt that it was my responsibility to obtain consent for those research aspects. This was in fact wrong and it never appeared in the final – this was never handed out to anyone and the consent forms … Well, all I can tell you is that this was an early and inadequate document which was never used, but you are correct in as much as it refers to my seeking to obtain consent, if you like, for the research aspects of my work.
Q It was drafted very early on, as you have pointed out to us, right at the very beginning, in October 1995.
A That is right, and it was not considered appropriate.
Q So in October 1995, which was the time we were considering, at the time when you say the research was an adjunct to a clinical study you were drafting a form for the parents which was exclusively asking them to take part in a research study?
A Again, this should be seen in conjunction with the consent forms obtained and evident in the records for other aspects of their investigation, the clinical aspects of their investigation. What I was seeking to do was to separate off the research aspects, the elements for which I was responsible.
Q In that case why do you not tell the parents what the research aspects are? You were suggesting the whole study was, “The study hopes to add further to our understanding of the possible links”.
A I have said, this document was inadequate and was never actually sent to parents, and a much more detailed description was subsequently produced.
Q We will come on to that but you are not suggesting that the consent form that went with this and the patient information sheet that went with this to the ethics committee, was drafted at the same time as this in October 1995 are you, or are you?
A No, no, no, this was something that carried over from the original drafting, and, as
I say, it should not have done so and it was not considered adequate and it was ultimately not distributed.
Q But it was sent to the ethics committee nonetheless?
A That is correct.
Q Why, just to confuse them?
A I cannot answer that question now, Ms Smith, I am afraid.
Q Going back to your original protocol at page 103: if this protocol was indeed driven by any clinical need why are you drafting it, and why are you the coordinating investigator?
A Because I had offered to take that role. I had put together a hypothetical background to what the mechanism might be and I offered to be the coordinating investigator. The clinicians were extremely busy and it seemed entirely reasonable that I should put the documentary aspects of this together.
Q I have suggested to you that it was all research but even on your own case, which I do not accept, at that early stage, all the elements that you acknowledge were for research purposes were in place in that document, were they not?
A In 1995?
Q In the document that we have at page 104, which would appear to be a 1995 document.
A No, I do not know when this document came into existence ---
Q Well, that is exactly why I put ---
A --- there will have been some form of document I believe in 1995 but I simply cannot say what state of completeness it was in, and I would say that it was probably in a relatively primitive form because this document took so long to ultimately compile.
Q But at any rate we know that this is the one that went to Mr Barr at the beginning of 1996.
A And that will, I believe, have been in June of 1996.
Q The question I asked you was that the elements that even you acknowledge were there for research purposes are in place in this early draft of the document, and I would like to digress for a moment to your table at D2/tab 12. Again, this is a document you put in when you gave your evidence in answer to Mr Coonan’s question. Again I have to make it clear that I do not accept the analysis that is in this document and I will be returning to it, but
I want to ask you on the basis of what you yourself are saying, your own case on this: if you look at the tests which you say required ultimately ethics committee approval as part of 172/96, they are at the bottom of the second page, under the research tests, and you said all the first tests were 162/95, and I am not going to ask you about that for the moment, then the neuropsychiatric studies were 172/96, and I am not going to ask you about that, but then I just want to look at the laboratory research tests. We see blood tests, complement studies, plasma total homocysteine, cobalamin coenzymes, cytokine measurement in the CSF and urinary MMA excretion, is that right?
A Correct.
Q Those are the tests which you say were part of 17296 and your research approval.
A Yes, specifically the MMA, the 24-hour sample was research.
Q If we go back to FTP1, page 114, we see the same tests, urinary MMA excretion. Then on the next page, plasma total homocysteine, plasma total cobalamin, cobalamin coenzymes; is that correct?
A That is correct.
Q If you also look back at 114, right from the very outset you envisaged cytokine measurements in the CSF from the lumbar punctures, which you now say was a research investigation, and we see that under the responsibility of Dr Harvey, at the top of the page under paragraph 3; is that correct?
A I am not sure what you mean by “right from the very outset”.
Q From the time when you drafted this document a very considerable number of months before your ethics committee application you had decided that you were going to do those research tests; they were what you wanted to do?
A Yes, at some stage during 1996 that decision will have been taken.
Q The copy that we have at 104 is the copy that you gave to Mr Barr, we are all agreed on that. What is at issue is whether you told Mr Barr to send it on to the Legal Aid Board or he did it of his own accord, is that correct?
A That is correct.
Q So you gave it to Mr Barr?
A I did.
Q To explain to him – and we will look at this in more detail – the nature of a study, you have told us, as an example.
A To give him a comprehensive background to my thinking about this disorder and to provide him with the relevant information.
Q So we can assume from that that you gave it to him at a relatively early stage after your relationship with him began, can we not?
A I think we probably have a date for him having this – the month of June.
Q June is when it was sent to the Legal Aid Board, Dr Wakefield, and you have told us that you first met with Mr Barr in January 1996, but it does not go to the Legal Aid Board until June of 1996. You have told us – and we will investigate that in a moment – that you did not have anything to do with it being sent to the Legal Board, and that is not what I am asking you about. What I am asking you about is when you gave it to Mr Barr.
A Yes.
Q And you have told us that you gave it to him to explain what the research was all about, in effect.
A It provides more than that; it provides a clinical and scientific background to the investigation of these children.
Q So you would have done so at a fairly early stage after you had met him and begun to discuss these matters with him.
A Again, I am not trying to be difficult but I do not know at which stage this particular draft was available and therefore given to him.
Q Can we go back to the first question that I asked you? I accept that you are uncertain as to the date but we know that whenever this document was prepared it was before the final version which goes to the ethics committee, do we not?
A Correct.
Q At that stage you had already planned all the research investigations that
I have just taken you to, which you say required 17296 approval.
A That is correct, yes.
Q Those are the tests which are on your table and that is why I have referred you to them because they are the tests that we can agree were part of 17296. What I am suggesting to you is that the whole of that protocol was research and that you knew, from whenever it was drafted, that ethics committee approval was going to be required.
A No.
Q You did not know? You put those in but you did not know that they were going to need ethics committee approval, are you saying?
A No. The whole of the protocol most certainly was not research and this was made very clear in the proforma document to the ethics committee when specifically asked if these are tests that would be conducted routinely in the investigation of children, then the answer is yes, they would; it is request for extra samples that is given.
Q I have taken you to and we have discussed the aims as you characterise them in that draft protocol and I now want to ask you in this context about another document where you set out your aims and that is in the records of Child JS, the local hospital records, volume 1, page 200. This is a document that I want to remind the Panel that your contention is that there was a final version to this, which you have produced. I am quite happy to go to that in a moment but I want to go to this one first of all because this is the one that is in this child’s records. We are now in February 1997 so all The Lancet children have been investigated. If we look at 203A we will see the date. And if we are to believe the printed signatures at the bottom of this document this was a document that you produced in collaboration in some way with Professor Walker-Smith, is that correct?
A That is correct, yes.
Q If we look at page 202: “What does this study hope to achieve?”
“The purpose of this preliminary clinical study is, firstly, to adequately and appropriately investigate the gastrointestinal signs and symptoms manifested by these children: investigation is merited on clinical grounds.”
That is in black print.
“It is our experience that these clinical features often have been ascribed to the inevitable consequences of behavioural abnormalities upon bowel function, and as a consequence the children have not necessarily been investigated adequately. It should be stressed, therefore, that the investigations are clinically indicated in all cases that are admitted for evaluation. The validity of this approach is borne out by the fact that most children investigated so far have significant and consistent intestinal pathology (lymphoid nodular hyperplasia and microscopic colitis).”
Then you go on:
“Secondly, the purpose of the study is to seek the presence, and to characterise the nature, of any intestinal and cerebral pathologies in affected children. In view of the coincident changes in both behaviour and intestinal symptoms we believe that this form of regressive autism, and perhaps other behavioural problems within the autistic spectrum, may be linked to chronic intestinal inflammation.”
First of all, can I ask you did you draft this or did Professor Walker-Smith; or do you recall?
A It was drafted together. I may have produced an early draft but it was a consensus document.
Q You may have produced an early draft, did you say?
A Someone has to write the first draft and that may well have been me.
Q We see in this version, “What does the study hope to achieve?”, a strong emphasis on investigation being merited on clinical grounds. You say it should be “stressed” that the investigations are clinically indicated, and the validity of the approach, you say, was borne out by what you had already discovered, is that correct?
A That is correct.
Q Then you go on, secondly, to the other aims and those, I suggest to you, are indeed consistent with your original protocol, namely:
“… the study is to seek the presence, and to characterise the nature, of any intestinal and cerebral pathologies …”
In other words, a more general aim; would that be fair?
A Yes, it provides a secondary purpose which is to characterise the disease further.
Q If the original protocol that we have looked at, Dr Wakefield, on page 104 was indeed with a primary clinical aim why is it that nowhere in that protocol do we see that the purpose, firstly, is to investigate the gastrointestinal signs and symptoms, because clinically that is the thing that matters, what you are now identifying in this document, is it not?
A I am sorry, I may appear to be entirely stupid, but this is an information sheet for doctors and it is trying to set out comprehensively the reason for investigating these children, with the emphasis upon the clinical merits of the investigation, and how in the experience of the clinicians the clinical manifestations may have been obscured or not investigated appropriately in the past. I could not put it more clearly now if I wrote it again that what we were trying to do was merited in clinical grounds.
Q Absolutely, and this is in 1997, after you have seen all The Lancet children.
A This document is in effect largely what I would have said when I was first contacted by the doctors without reference to the fact that this is what we found. It is just a distillation, if you like, of our thinking and it is reflective upon the clinical experience of the first 12 children.
Q Yes.
A It says what the study is about, primarily clinical; secondarily, research. I am not sure what you are saying.
Q The point I am making, Dr Wakefield, is that it is not what you said originally. As we have already established you referred only to the research aims and now in 1997 we have in bold print that it is a clinical study and you emphasise that the investigations are clinically indicated, and you say that the whole purpose of it – and it is perfectly straightforward language, the first two sentences under “What does this study hope to achieve?” – is to investigate these children’s gastrointestinal signs and symptoms. What I am suggesting to you is that if it is so easy to say it there why do we not see it in any information that was prepared before The Lancet 12 were seen.
A You do, with respect. If we go to the document that I referred to just now, which is the completed proforma, you see – if I can take you to it – on page 232, that seeks to provide a body of information to the parents, but this is intended for doctors primarily. The form that I prepared, which was the information sheet, that consent form was identical but it was for the research aspects for which I was responsible and that is why it finds my name on it. The consents for clinical investigations, as I say, are to be found in the records and they refer to colonoscopy biopsy, lumbar puncture MRI and the research under 16295 and taking extra biopsies.
Q You have taken us to this document and I am happy we should look at it now. You tell me where this document prepared for the parents makes the point that these investigations were to characterise their individual child’s gastrointestinal symptoms? If we look at the second paragraph:
“We would like to carry out a series of tests which, we believe, will help us to establish the features of this possible disease. Our aim is to characterise the problem so that, for the future, we may be able to treat affected children and improve their wellbeing.”
I suggest to you that that again is exactly the same as the original profile, which has a clear research intent.
A No, it is not. I would emphasise once again, just in case there is any doubt whatsoever, that this was driven by a clinical need and there is no question about that. It is a question that was asked time and again and has been confirmed on many occasions by Professor Walker-Smith, with the primary objective that it is in response to parental requests and parental concerns about symptoms in their child. This was driven by clinical need.
Q If we look at page 232, which you have invited us to look at, and you have told us it is what the parents understand that matters:
“Through parents such as you, doctors at the Royal Free Hospital School of Medicine, have been alerted to the possible existence of a new disease …”
And you said what it is:
“The problem has been associated anecdotally, but consistently, with measles or measles/rubella vaccination. We, at the Royal Free, have now looked into the background medical and scientific literature concerning this problem, and have formulated the hypothesis that in certain (perhaps genetically susceptible) children, live-virus vaccines may produce long term inflammation of the intestine …”
And you explain a failure to absorb vitamin B12. And we see:
“We would like to carry out a series of tests which, we believe, will help us to establish the features of this possible disease. Our aim is to characterise the problem so that, for the future, we may be able to treat affected children and improve their well being.”
That is of the nature of research, is it not? “Possible existence of a new disease; formulated the hypothesis; looked into the background medical and scientific literature; characterise the problem so that we can help children.”
A In the routine investigation of children with symptoms such as gastrointestinal symptoms there is no such thing as a handout; there is no information required over and above that communicated by the physician to the patient in the clinic. This kind of handout to parent(s)/guardian is a research element, as Ms Smith has said, and is required by the ethics committee for research aspects and therefore does not refer specifically to clinical aspects. That is because it does not need to and those have been covered by the physician in his interaction with the parent in the clinic. This, nonetheless, is a document that is prepared by necessity because of the requirements of the ethics committee.
Q So the parent reading this will understand that what is said in here is about research; that is what you are saying, is it?
A And in addition will have understood, based upon their initial request for an appointment and the consultation with Professor Walker-Smith as to what the clinical indication for their investigation is as well, yes.
MS SMITH: Then if we look at the rest of it, doctor – I do not want to read the whole thing out – but “You and your child will be admitted” ---
THE LEGAL ASSESSOR: Ms Smith, I am sorry to interrupt, but as I understand it, your question is on the basis that where it says, “Our aim is to characterise the problem so that, for the future, we may be able to treat affected children”, are you saying this does not include the children who are going to be the subject matter?
MS SMITH: I am saying that even if it does include the children who may be the subject matter, it is a research aim because it goes to the overall aim of treating both those children and other children. Perhaps ---
THE LEGAL ASSESSOR: But your questions are based, are they, on the premise that the children – these children, the subject matter – are, if appropriate, going to be treated?
MS SMITH: They may be, yes of course. They are not going to be excluded if some
THE LEGAL ASSESSOR: At one stage it sounded as though you were suggesting this did not apply; that the subjects of them were not going to be treated. I now understand you are now implying that.
MS SMITH: No. Can we go on to the rest of it, please, Dr Wakefield? I will not read it all out. We see a very detailed description of all the investigations that the child is to undergo – all the ones that you say are clinically indicated and are not part of this form?
A This is an honest and detailed attempt to convey to the parents what the exercise will be, and encompasses a description of the programme at the Royal Free. It is an attempt to provide as comprehensive a picture to the parents as possible. I am still at a loss to quite understand why this is considered a pure research exercise when it has been made quite clear throughout proceedings and through the documents that have been adduced that this is a research exercise. It is not.
Q I hope you still have the records of JS open. It is page 202, at the bottom of the page, where you stress that –
“the investigations are clinically indicated in all cases that are admitted for evaluation. The validity of this approach is borne out by the fact that most children investigated so far have significant and consistent intestinal pathology …”.
And we are now in February 1997, when you had seen all the Lancet children. Is that right?
A Yes, that is correct.
Q So you are giving the findings in the first twelve children as a justification for clinical investigations on the subsequent children?
A No. The justification for the investigation of the first twelve, as with all other children, was the presence of significant gastrointestinal symptoms, as I understand it, and as was the case. What we are merely stating here, or what is being stated here, is that the approach was valid and has revealed inflammation in these children. Nothing more and nothing less than that.
Q Of course, you did not have those findings when you started off on the first twelve, did you?
A No. We did not. We had findings cumulatively over time with more and more children having inflammation, and I think Professor Walker-Smith referred in a number of letters to colleagues, “We have investigated two children so far and found inflammation.” “We have investigated three or four children…”, and so on and so forth.
Q Was the purpose of that later document, Dr Wakefield, with the particular bold type wherever clinical investigation is mentioned, a defensive one because you realised that you and Professor Walker-Smith were open to the charge, at least, that you had conducted research investigations on the first twelve children?
A It was not defensive at all. It was by way of emphasis to the doctor that consideration should be given to possible intestinal disease in children whose symptoms were otherwise obscure – in other words, as I have said earlier, they could not articulate abdominal pain but often manifest that in odd ways such as self-injury, sudden outbursts of anger. It is a particularly difficult group of children with which to deal because they are unable to express themselves.
Q What I am going to suggest, doctor, and you should have the opportunity to comment on it, is that as far as the first twelve children were concerned this was, in effect, a scientific fishing trip, with a perfectly proper motive in that you hoped you might find something which would help their condition, but was nonetheless a research motive?
A No, it was not.
Q Can we revert to the chronology, we have discussed the original draft protocol. I want to go on, as I say, to get an overall look at the chronology of this case before I go into the detail on it. You have explained to us how the genesis of your research arose through Mrs 2, and you have told us about the deferral of referrals until Professor Walker-Smith arrived at the Royal Free. You met with Dawbarns in January 1996 to your recollection. Is that correct?
A That is correct.
Q You gave them your draft protocol at some point after, presumably, you had entered into a formal arrangement that you were going to act as an expert. Is that correct?
A Yes, very likely.
Q And you say you gave it to them as an example of a study that sought to answer the question of a possible causation between these vaccines and Crohn's disease in the first instance, and latterly autism. You said this was an example of that. This is Day 49/35.
A This was given to them by way of information, detailed information, of my perception of what the problem might be. In other words, outlining a hypothetical background for what might be going on and a way in which it might be looked at.
Q So the study which you say was driven by the clinical needs of the children was also a study which was the kind of study that would be useful for the litigation?
A The question that was put to me by Richard Barr was, “If you were going to take this forward and ask the question or seek evidence of a causal relationship between these vaccines and this condition, how would you go about it?” And with reference to the extensive work that we had conducted on Crohn's disease, then the first approach would be to examine the disease tissues for the evidence of the virus and specifically those areas of the disease tissue which one would expect to reflect changes associated with a viral infection, in this case the swollen lymph glands. That was the way in which we had set out the approach, or I had set out the experimental approach in this document, was to examine the tissues, initially by immuno-histochemistry and then later by the polymerase chain reaction looking for the gene for the virus. So this document encapsulated that approach.
Q This document – the clinical and scientific protocol that we have been looking at – set out what you proposed to undertake on these children, to explore a link between gastrointestinal disease, autism and a possible vaccination cause. Is that right?
A It contained that, yes.
Q And that is the very subject which Mr Barr wanted to investigate for the purposes of the litigation?
A He had put the question to me of how I would approach it scientifically and I was able to provide an answer.
Q Yes, because the study that you were planning to undertake at that stage in January 1996 had the same aim as Mr Barr’s aim, namely to investigate the links between the vaccine, autism and gastrointestinal disorders?
A Mr Barr did not necessarily have the clinical aims. He was focused on the issue of evidence for or against measles virus having a role, or the MMR vaccine.
Q Absolutely. I accept that. And he came to you, did he not, to advise him as to the medical evidence that he would need?
A Because I clearly had a specific interest in that area.
Q And you provided him with the study that you wanted to undertake into that very area?
A That is correct, yes.
Q Would you go to FTP1, please, at page 90. I took you briefly to this before. This is Dawbarns’, the solicitors, newsletter that they were sending out, as I understand it to potential litigants and any others who might be interested in the litigation. This is a document which you say you would not have seen. Is that correct?
A I was not sent these, and I contributed to them in no way. It is not my document.
Q No. We all understand that, Dr Wakefield. May I just ask you for your comments on what Mr Barr has said in it?
A Could you take me to the page again, please.
Q It starts at page 90. You see the date on the next page, February 1996. It is in FTP1, page 90. Have you found the document?
A I have, yes.
Q We see at the start, this is simply the news that Mr Barr has been giving, and I appreciate this is nothing to do with you.
“A lot has been happening in relation to the work we are doing for you on your vaccine claim. I am sorry if for some of you things have seemed a little quiet. The reason for this is that we have been concentrating for the whole of the second half of last year on very extensive research and preparation in relation to the whole general case.”
If we go on to page 91, we see the reference to you at the bottom of the page.
“As you may have read in the Sunday Times of 17 December 1995…”
And I think that is a reference, is it not, to the publicity which your 1995 paper was given, linking Crohn's and possible vaccination cause?
A That would be right.
Q
“… Dr Andrew Wakefield has published some very disturbing material which indicates a clear link between the measles element of the vaccine and Crohn's disease (a persistent inflammatory illness of the digestive system). He has deeply depressing views about the effects of vaccines on the nation’s children.”
Would that accurately represent your views at that time?
A This is not mine. I simply cannot provide any insights into anything that is written in this document.
Q Dr Wakefield, I am not asking you to provide insights. I am asking you to comment on whether you think that Mr Barr had got it right or wrong when he said you had deeply depressing views in relation to vaccines. Sorry. “…the effects of vaccines on the nation’s children.” Is that right or wrong?
A It is wrong.
Q It is wrong? What was wrong about it?
A My own children had been vaccinated. If I had deeply depressing views, that is not something that I would have undertaken. It seems to be a very broad brush statement about vaccines on the nation’s children when my interests were focused upon specific vaccines and a specific group of children.
Q So that if Mr Barr had instead said that you had very deeply depressing views about the issue of whether Crohn's disease was caused by vaccination, would that have been a fairer representation of your views at that time?
A No. It would have been fair to say that I had concerns about the possible link between these vaccines and Crohn's disease.
Q They were pretty strong concerns, were they not, Dr Wakefield, because we have seen the correspondence that you had had at an earlier stage with the Department of Health. You did have deeply depressing views, did you not? You thought there was a problem?
A There is a big difference between thinking there may be a problem and deeply depressing views.
Q If we go on:
“He is also anxious to arrange for tests to be carried out on any children vaccinated with the Mr or MMR vaccine who are showing symptoms of possible Crohn's disease. The following are signs to look for. If your child has suffered some or all of these symptoms could you please contact us and it may be appropriate to put you in touch with Dr Wakefield.”
Then it sets out a list of signs and symptoms that the parents should look for. Did you provide Mr Barr with that list of signs and symptoms? Did he ask you what sort of things he should tell parents to look for?
A No, I did not. I refer specifically… First, let me say, I had absolutely no role in preparing this document. I just want to reiterate that. If the Panel will just go down that list, the reference to anal polyps. Anal polyps is something that I have never seen described as such in Crohn's disease and not a description that I would ever have applied to it.
Q I will revert to this newsletter, if I may, Dr Wakefield, save to ask you this. It is correct, is it not, that you were anxious to arrange for tests to be carried out on children who had been vaccinated who were showing symptoms of possible Crohn's disease. Do you accept that?
A No, I was not. I was not in a position to do any such thing.
Q When you say you were “not in a position”, what do you mean by that?
A I have no clinical role. I cannot conduct tests.
Q You can conduct research tests, can you not?
A Conducting research tests requires, as we have seen, the procurement of tissues from patients for those tests.
Q Yes.
A That would require in-patient management of that child. That is not something in which I was involved.
MS SMITH: No, but at this time in February 1996 you had already formulated your protocol that we have been looking at, and it is fair to say that you were anxious to conduct tests. You were anxious to conduct a protocol, were you not, that you had formulated.
MR COONAN: I am sorry to interrupt. The premise of that question has not been established, with reference to the date in February 1996.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: I would like to hear what Ms Smith has to say.
MS SMITH: I may have misunderstood Mr Coonan’s objection, in which case I am sure he will put me right. (To the witness) Dr Wakefield, you had at that time the draft protocol that we have looked at. I think I probably have misunderstood what Mr Coonan wants. Excuse me. (Pause) (To the witness) You had an early draft of the protocol in October 1995, as you have told us, Dr Wakefield. Is that correct?
A I think we are probably confusing two things. One is Crohn's disease and the other is autism and possible bowel disease. The reference made by Mr Barr here is exclusively to Crohn's so I am not sure where the overlap comes between that and the protocol.
Q You had a protocol in draft which was looking at links with gastrointestinal disease, that is correct is it not?
A Possible gastrointestinal disease in children with developmental disorders. There is no mention in this paragraph.
Q Gastrointestinal diseases would include Crohn’s, would it not?
A Yes, but the protocol to which you refer was very specifically to children with developmental disorders and gastrointestinal symptoms.
Q So any reference by Mr Barr to you having any interest in carrying out tests at this time on children with Crohn’s disease, who had also been vaccinated, you are saying that is incorrect on the basis of the protocol that you have told us was in draft of the autumn of 1995?
A Absolutely, yes.
Q Just going on, if I may, and, as I say, I shall revert to that news sheet when I am asking you about your involvement in more detail in the litigation. The next child after the early referral of Child 2 in 1995 was Child 3, and we can see that from your D8 document if we wish to. I want to ask you about a letter, which Mr Coonan asked you about, in Child 3’s records, would you look the Royal Free records at page 40. This is a letter that was written to you by Professor Walker-Smith in April of 1996, and he sets out some of the background of the child and the fact that there had been a change in behaviour after his MMR injection, and he says what his findings were on examination, and then he says:
“I have not yet booked for a colonoscopy until we have got the full details of the investigative protocol worked out.”
What was your understanding when you got that letter of what he was referring to as still needing to be “worked out” as of April 1996?
A At that stage it may well have been that discussions were taking place with respect to clinical investigations that should or should not be included in the protocol, such as the taking of spinal fluid for analysis of lactate, for example, and in accordance with the diligence that Professor Walker-Smith applied to the design of the clinical aspects of this study, it seems to me that he is not prepared to go ahead with the clinical investigation of this child until the clinical protocol is worked out.
Q If he is writing to you was that not because the full details involved your input?
A It is Professor Walker-Smith’s letter and he will be able to answer to that, but nonetheless what he is clearly expressing is that the protocol is still in the process of being designed or finalised and he is awaiting that completion.
Q Because, as you have told us, there were a number of drafts of the original protocol that we have looked at.
A That is right, and my understanding from this, since Professor Walker-Smith was in charge of the clinical aspect, is that it was the clinical aspects that had not yet been finalised.
Q Then why would he need to be telling you? Do you know? Can you help us as to that?
A It may well be that I was in the clinic or just by virtue of courtesy because we had established a collaborative multi-disciplinary team, and, again, you will see many letters form Professor Walker-Smith to me, copied to me, keeping me informed.
Q That was April 1996, and in May 1996 we have Professor Walker-Smith asking to see Child 2 again, who, of course, was the first child who had originally been referred to you in May, and I would like you to look at that, Child 2’s Royal Free Hospital records page 165. I understand that again this is not your letter and I only want to ask you about that part of it about which you may have some comment, but it is a letter to Mrs 2 from Professor Walker-Smith saying that it would be helpful if he saw Child 2 again, and he said:
“I have had discussions about [Child 2] with Dr Wakefield. We have a plan for investigation but I think if it were convenient for you, it would be helpful for me to see [Child 2] first in outpatients …”
Do you accept that you had discussions with Professor Walker-Smith about Child 2 which resulted in a revisiting, if you like, of Child 2’s case?
A I think as I mentioned in my evidence, Child 2’s mother contacted me soon before this letter, soon in advance of this letter, to explain that her son’s condition had deteriorated considerably both in terms of his gastrointestinal symptoms and his behavioural symptoms and I passed that information on to Professor Walker-Smith.
Q So the discussions were simply your signposts were they?
A That is correct.
Q We will come back to that when we look at Child 2. Would you now go to the local hospital records for Child 3, at page 180? Again this is not your letter, it is a letter from Professor Walker-Smith to Dr Rosenbloom, who we know is a consultant paediatric neurologist at the Alder Hey Hospital in Liverpool:
“Thank you so much for enclosing [Child 3’s] notes which I will let you have in due course. I am actually passing on your letter to my colleague Dr Andy Wakefield who is the inspiration of our work linking MMR, autistic behaviour and Crohn’s disease and I am asking him to write to you to fill you in on our proposed study.”
I know you cannot help, and I entirely accept that, how Professor Walker-Smith describes you but would you accept that description, that you were the inspiration behind the work?
A It is very generous but it is vicarious, the inspiration was effectively Mrs 2 and mothers like her.
Q I suggest to you that that is the literal truth. In other words, at this stage, in May 1996 you were driving this project.
A The project was, as you have referred to it, once again being driven by clinical need – clinical need in the individual and the perception of an unmet clinical need in this group of children.
Q Just in passing, doctor, whilst we are looking at this letter, it would appear that Professor Walker-Smith was using Crohn's disease there in a more generalised sense. Would that be fair – the reference to gastrointestinal disease?
A I think Professor Walker-Smith will be able to answer for this, but I have not linked MMR to Crohn's disease; rather the single vaccine, or measles itself, but I think that is a minor issue.
Q So he is incorrect in his description of your work, is he?
A To a minor extent, yes.
MS SMITH: Sir, I have reached in the chronology a break, and I shall be going on to a relatively new matter although I am going to continue on with the chronology through some of the children’s records, so I can stop there if you wish me to. You said quarter to twenty past, or I can go on.
THE CHAIRMAN: I am also thinking for Dr Wakefield as well. He has been answering these questions since this morning. I think it is probably right, and I think this is the time to call stumps for the day. Can I once again remind you, Dr Wakefield, that you are still under oath and still in the middle of giving evidence. Therefore please make sure that over the week-end, once again, you do not discuss this case with anyone, including your lawyers.
We will now adjourn and resume at 9.30 on Monday morning.
(The Panel adjourned until Monday, 14 April 2008 at 9.30 a.m.)
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