GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Monday 31 March 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
WAKEFIELD, Dr Andrew Jeremy
WALKER-SMITH, Professor John Angus
MURCH, Professor Simon Harry
(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
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued 2
THE CHAIRMAN: Good morning, everyone. Good morning, Dr Wakefield. My apologies to all of you for this unexpected delay. I believe we are ready to start. Mr Mellor?
MR MELLOR: Thank you, sir. I actually only have one housekeeping matter. The other is a matter for Mr Miller, which relates to Professor Walker-Smith’s response to charge 21(a), so he will deal with that.
As far as the housekeeping matter that I have to deal with, it relates to the GMC’s list of references to the medical records which was provided to the Panel during the last session, prior to the experts giving evidence and has been provided to the Secretary to the Panel in electronic form at the end of last week. There should be hard copy, I think, in front of you all on your desk. It relates simply to an error in the introductory notes which I spotted when I was emailing it to the Panel Secretary on Friday. It is paragraph 5, which is on the second page, which states:
“The list below takes each child in the same order as the cases were dealt with in opening and as they appear in the charges; this is in the order in which the children were referred to the Royal Free.”
The second half of that is obviously incorrect. The children are listed in the order that they appear in the charges and the order they were dealt with in opening. Child 2 is dealt with first, being the first child that was referred to Professor Walker-Smith whilst he was at Barts. Thereafter, the children are in the order that they were actually admitted for investigation at the Royal Free.
THE CHAIRMAN: In other words rather than “children were referred”, it will be “children were admitted”?
MR MELLOR: “Children were admitted to the Royal Free”, save for the first child, Child 2. He was the first child referred to Professor Walker-Smith. As the paragraph continues, Child JS follow the Lancet children. That was the minor housekeeping matter, sir. Thank you.
THE CHAIRMAN: Thank you very much indeed, Mr Mellor. I take it from Mr Coonan, Mr Miller and Mr Hopkins there is no objection to this slight alteration which seems to be a common-sense alteration. Right. Thank you very much indeed. Mr Miller, I believe you are going to deal with the next matter.
MR MILLER: I would not get too excited, sir. It is 20(a)(i) on page 58 of the yellow bundle of charges. There was a question mark about whether or not that had been admitted at the beginning of the hearing. Just to clarify it. It remains not admitted – 20(a)(i) and (ii). I will obviously explain in due course why that is.
THE CHAIRMAN: Thank you very much indeed. Mr Coonan, you were in the middle of the examination in chief.
MR COONAN: Yes, sir, I was.
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued
Q Dr Wakefield, do you have with you volume 2 of the Panel bundle, please? (Handed to the witness) Could I ask you to turn to page 471? On Friday we had got to the point in the chronology – and if one needs to one can simply turn back to page 470 but I will save time and re-cap it – whereby Professor Zuckerman had suggested or directed or audited (whichever is appropriate) that the money which had been received by the medical school should be transferred to the special trustees. Right?
Q Here on 23 May 1997, this is a letter from you, which we can see on page 472, addressed to Mr Phipps, the director of finance at the Trust. I am going to look at this in some detail. I am going to read parts of it out. Can you follow it with me?
“My group, The inflammatory Bowel Disease Study Group, is currently involved in the investigation of a cohort of children with regressive autism and inflammatory bowel disease. The study is being undertaken in collaboration with Professor John Walker-Smith in the Department of Paediatric Gastroenterology. The study has provided some ground-breaking insights into the mechanisms of autistic spectrum disorders, and in particular, the role of intestinal inflammation in this condition.”
I just pause there for a minute. The 23 May 1997 – would you just turn to D8, which is the chronology on referral submissions and investigations and just look at it. By this date, May 1997, had all the children who were to become The Lancet 12 children been investigated?
Q In the second paragraph you go on:
“Children for this investigation have been recruited as ECRs from all over the country…”.
Just pause there. Is there any significance to the word “recruited”?
A It certainly has no significance in any legal context at all. The implication, or at least my intention, was to suggest that these children had come from, and had been referred from, their general practitioners around the country.
“…. and indeed, as private patients from the United States of America. In order to initiate the study, Martine Else and the Special Trustees of the Royal Free Hampstead NHS Trust were kind enough to set up an account to fund Ms Rosalind Sim as the technician to process the samples taken from the children.”
Pausing there, did we see a reference to that on Friday in correspondence?
A Yes, we did.
“This has proved to be most successful and will continue to be a major source of revenue for the Trust itself. In addition, we have been awarded a grant of some £50,000 by the Legal Aid Board to investigate the possible association of this syndrome with the MMR vaccine. This money has been provided through Dawbarns Solicitors (see enclosed documentation) for the express purpose of performing the study outlined in the enclosed protocol.”
Just pausing there, do you want to comment about the way you phrase that?
A The documents submitted to the finance department, the Special Trustees, will have included the costings proposal to the Legal Aid Board which was, in effect, the Legal Aid Board protocol and the broader protocol which by this stage had clearly received approval by the ethics committee.
“This protocol, as you will see, has been approved and passed by the Ethics Committee of the Trust.”
That is just leading on from what you have just said. Can you just help about that sentence, please? We are now looking at May 1997. What do you mean when you said that, as you did in that sentence?
A The protocol for the investigation of these children according to the Legal Aid Board pilot study was principally the viral detection, and this is subsumed under the approval obtained in 172/96 which, by this stage, has been approved by the ethical practices committee and I would have included the letter of approval to reassure him on that.
Q Again, please, I need to ask you what investigations are you intending to refer to when you said that they had received ethical committee approval?
A I am referring here specifically to the scientific investigations, laboratory investigations, under my jurisdiction and that is principally the detection of measles virus in biopsy tissues.
“The cheque for the first instalment of this grant was initially paid into the Medical School, but queries have been raised by The Dean, since this source of funding has never been obtained before.”
Again, that may be self-evident. Would you agree, as a general comment?
A Yes. The dean has referred to problems with this funding but has not specified those to me other than that this is an unusual source. In my response to the dean, I express my misunderstanding or my lack of understanding of what he meant by “a conflict of interest”. He had not explained it to me at that stage. It later became apparent.
Q You go on:
“I have discussed this with both Professor Pounder and Cenghiz Tarhan and we are agreed that the money would be more appropriately located in the account currently held to pay for Ms Sim, since this account pays the existing expenses of the same study (ie salary).”
There are a number of matters I want to seek your clarification about in respect of that. As matters then stood what work was Ms Sim in fact engaged on, as of that date?
A Ms Sim, as I mentioned last week, was an expert in immuno-histochemistry. There were two aspects to her work. One was the characterisation of the disease process in the intestine, asking questions for example to the effect that is this like Crohn's disease, is it like ulcerative colitis? Is it different from these diseases and, if so, how? The second aspect of her work was a viral detection study looking principally for measles but also for a range of other viruses.
Q Was the money which was being used to pay for her work at that stage the money which was the subject matter of the correspondence that you referred to on Friday?
A Yes. It was a grant allocated to this project from the funds held by the Special Trustees.
Q Just to remind ourselves about that, would you just take volume 1, please and turn to page 192. Is that the reference back that you referred to on Friday?
Q You have described therefore the work that Ros Sim had been doing up to now. What had happened to the original plan involving Silke Schepelmann?
A Clearly the school had awarded Dr Schepelmann a two year contract. The school, in its refusal to accept the funding from the Legal Aid Board, meant that she could not be paid from that grant. Therefore I was charged with going out and finding alternative funding to cover Dr Schepelmann’s work; in other words, she never worked on the Legal Aid Board pilot study.
Q Did she work on other matters?
A Yes, she did.
Q Therefore, if Dr Schepelmann was now no longer available, who was going to do the Legal Aid Board work?
A At that time two things happened. One is that Ros Sim was available and expert in this technique, and therefore could conduct it. The other – and Dr Murch will correct me if I am wrong – that his group which had a particular expertise in immuno-histochemistry – were taking a greater interest in characterising the bowel disease itself and had developed some very interesting ideas on how they might look at the inflammation that we were finding in these tissues. So there was an increasing emphasis from Dr Murch’s laboratory in the conduct of the disease characterisation and this effectively left Rosalind Sim free to devote herself exclusively to the viral dedication and therefore possibly the Legal Aid Board pilot study.
Q At the time this letter was written, did you have it in mind that she would work on the Legal Aid Board study?
Q Therefore, if one looks at the bottom of the second paragraph,
“…we are agreed that the money” – that is the Legal Aid money – “would be more appropriately located in the account currently held to pay for Ms Sim…”
Pausing there, what did you intend when you wrote that?
A What I intended was that at this stage if Rosalind Sim’s efforts were going to be devoted entirely to the Legal Aid Board pilot study – that is viral detection – then it was only right and proper that that study, that funding, should pay her salary at that point, and therefore to pay that money into the grant that pays her salary so that that could happen. That was my intention, that was my understanding and, as we come to later documentation from Martin Else, that was his understanding as well.
Q Was it your intention therefore that as and when Ros Sim began the Legal Aid Board study she would be paid for out of money drawn down in the same account from Legal Aid Board money?
Q If that were to have happened, did you intend that the special trustees should be paying her salary out of its own money?
A No, that was to stop at that point. When I first applied to Martin Else for this rather unusual source of funding, as I mentioned last week, the Special Trustees handled funds usually coming from elsewhere but did not themselves fund projects, and I had undertaken to Martin to continue to seek external funding for this project, albeit that it had been somewhat difficult to come by and here was an opportunity not only to devote Rosalind Sim’s entire time exclusively to the Legal Aid Board pilot study but also to fulfil that obligation to Martin Else.
Q When you wrote that letter, did you think, did you believe, that the suggestion that you had made, apparently based on an agreement, did you understand that that would be carried not effect?
A Yes, I did. Part of the documentation that was sent to Mr Phipps was the costings protocol from the Legal Aid Board, or the one that was sent to the Legal Aid Board to raise the funds, and, as you may remember, at the bottom, the last paragraph of the first page it designates specifically what the first tranche of money from the Legal Aid Board would be used to pay for, the setting up costs, and that was a technician’s salary. That was, at least in my opinion, self-evident to Mr Phipps and the Special Trustees.
Q Again, before we move on but just taking matters as they stood in May of 1997, what did you believe that that first tranche of money, the £25,000, therefore would be spent on going forward?
A This was specifically to cover the salary of Ms Ros Sim now and to cover the cost of the reagents and laboratory elements that would be required from the conduct of that study.
Q We will come back to what happened to the money in a minute. Before leaving this letter could we just go back, please to the bottom of 471? You go on:
“I should add that the conduct of this study and the discoveries we have made have elevated the Royal Free Hospital to great heights in the world of autism research.”
Pausing there, was that on the basis of the investigations which had been completed by May 1997?
Q You go on:
“We are receiving referrals on a daily basis and the funding provided by the Trustees will continue to help us investigate these patients appropriately. The study itself, although commissioned by the Legal Aid Board, seeks only to establish the validity of the parents' claims of an association with MMR or not, and not to provide a specific answer, that is that vaccine as the cause.”
Was that the position, Dr Wakefield, as you set out in that sentence?
A Yes, it is an attempt to provide a balanced, scientific perspective of what our remit actually was.
Q When you said in that sentence, “The study itself, although commissioned by the Legal Aid Board…”, what study were you referring to?
A This was the reference back to the original study that Mr Barr had asked me to design, and that is detection of measles virus in the diseased tissues.
Q If we turn on to 492, about a month later Martin Else at the Royal Free writes to you, 30 June 1997,
Further to our conversation regarding the establishment of a fund with the Special Trustees for your income and expenditure associated with the MMR research, I can confirm that a grant will be established for the purpose, given your written confirmation that there is no conflict of interest involved.”
Leave aside the reference to conflict of interest, which I will come to in a minute, when Mr Else said that he could confirm that a grant would be established for the purpose, did that in any way disturb your understanding set out in the letter we have just looked at, at page 492, that the money would be paid into the same account used to pay for Ros Sim?
A I do not think at the time, given my specific instructions, this caused me any concern at all. I do not think I associated anything with it.
Q The reference to the conflict of interest, I think more light is shed on that if you turn the page to 493, your reply three days later.
“Further to our conversation the other day and your subsequent letter, I am writing to confirm that there is no conflict of interest in relation to the Legal Aid funding for our clinical study of children with autism and intestinal inflammation.”
I will come back to the beginning of that next sentence but drop down two lines to the sentence beginning,
“Furthermore, there is no intention whatsoever on behalf of the Legal Aid Board or its agents to take action against the National Health Service: it is against the manufacturers of vaccine that any future actions will be taken if and when our studies indicate that is a valid strategy.”
Again, and I do not want to spend an overlong time on this, what was the issue about conflict of interest raised by?
A We had spoken on the phone about this prior to this letter and he had had some discussions with Professor Zuckerman, and at this stage Professor Zuckerman, as I mentioned before, had not enlightened me as to what his particular concerns were with the conflict. He had raised with Martin Else I think the possibility of the Department of Health or the National Health Service being sued. The specific question that Mr Else raised with me was: was there an intention to sue the National Health Service? Martin Else, as a member of the Executive of the Trust, was a representative of the National Health Service and from my understanding at that time there was absolutely no intention for action to be taken either against the Department of Health or the National Health Service. I was able to reassure him on that.
Q From his standpoint, can you understand how an issue about conflict of interest in those respects might have arisen?
A Yes, I can. If he was on the one hand representing the National Health Service and on the other hand permitting a study to go forward that might lead to litigation against the National Health Service, I can see that he would have had reasonable concerns.
Q Let us go back to the second paragraph. “This study, which has been sponsored by the Legal Aid Board….” and then you go on to make a comparison with an investigation in to Gulf War Syndrome, which I am not concerned with. When you said, “This study, which has been sponsored by the Legal Aid Board…” what study were you referring to?
A I am specifically referring once again to that study that I had been requested to undertake by Richard Barr, which was principally the viral detection study.
Q In the third paragraph you say:
“Please find enclosed a copy of our first paper submitted to The Lancet concerning the children under investigation.”
That letter is dated 3 July 1997. Certainly by reference to this document – there may be others – can you help the Panel, please: had at least the first draft of what turned out to be The Lancet paper been submitted to The Lancet by this date?
Q Had the Legal Aid pilot study begun by this date?
A No, and again by definition it could not have begun until the funding was available for that particular study to be spent.
Q At 495, later on in July, on an internal document, Mr Phipps tells Mr Tarhan at the Royal Free Hospital School – so now it is the Trust talking to the School –
“I can confirm that it is in order for you to transfer the total amount of funds in question to the Special Trustees. Please quote the reference G106…”
Did you have any knowledge of those arrangements at the time, Dr Wakefield?
A No, I do not think I had specific knowledge of that but I had assumed that everything was proceeding.
Q In accordance with what?
A With my instructions.
Q In the letter at 471?
Q I just ask you this: did you in fact know or appreciate in July of 1997 that the money would go into this particular account called G106?
A On a matter of clarification, my understanding was that I had a single account with the Special Trustees and that account held a number of funds including that it was the account that paid for the salary of Ros Sim and that this money was to go, according to my instructions to Mr Phipps, into that account.
Q So did you know that, as it may turn out if we look at it, there was more than one account?
A No. In fact I only realised during the course of this hearing that there was more than one account handling my funds within the Special Trustees. That was complete news to me.
Q We will follow the mechanics of this through, not least because it is now many months since this was looked at by the Panel first time around. Can we look again at page 605C, please? This is the cheque drawn on the School of Medicine signed by Professor Zuckerman in favour of the special trustees for £25,000. So the money is coming across – is that right – some nine months after the cheque had been received by the School?
Q That money – if we just turn back one page to 605B, somebody has helpfully drawn a line under the cheque – we can see was paid into account G106 on 4 September 1997. Do you follow that?
Q Again, when did you first see these documents?
A During the course of this hearing.
Q Now we have got to September 1997 and I am going to ask you, please, to assist the Panel, Dr Wakefield, by looking chronologically at the next period of time, which is September 1997 to the very early part of 1999. You have told the Panel that the money which had been paid over by the Legal Aid Board was now available to be drawn down from for the purposes of the Legal Aid study. Is that correct?
Q Authority for the payment having been made almost a year before in August 1996.
A That is right, yes.
Q By this date, September 1997, had you completed and carried out one of the matters which you had agreed to help Richard Barr with, namely, the composition of a safety report?
A Yes, I had.
Q Where had you sent that?
A Just one correction there. The safety report was a living document; it was something that I regularly updated. So to say it was complete at that stage – I would say the interim report was complete, but I continued to update it.
Q Had he had a copy or copies of the document which was a living document?
Q You have told the Panel that the first draft of The Lancet paper, certainly by reference to a letter at page 493, had already been submitted to the publishers.
Q The other matter I want to ask you about by way of background to this period coming up is whether the patients, the children, at or about this date had been identified or selected, whichever term is appropriate, by Richard Barr to be included in the Legal Aid pilot?
A The identification of these patients was a protracted process because, as I referred to last week, it required that the parent indicated to Mr Barr that their child was being or had been investigated at the Royal Free and, when five children with autism and five children with Crohn’s had been identified who overlapped, who effectively had been see at the Royal Free or had tissues taken elsewhere, who were also clients of Richard Barr’s in receipt of a Legal Aid certificate, then that child was considered a possible candidate for inclusion in the study. What remained for me to do at that stage was simply to identify that that child had adequate biopsy material for analysis such that they could be included in a meaningful way. So by August 1997, that list was complete.
Q Again, did you by August 1997 have your five patients from each group?
Q As of September 1997, when the money was available to be drawn down, did you then give instructions to Ros Sim to commence the Legal Aid Board pilot?
A Yes. Her salary will have been paid for September from the existing grant and she will have started on that Legal Aid Board as of October 1997. I told her to focus exclusively from that stage on on viral detection studies as part of the Legal Aid Board pilot.
Q As far as you know, is that what she did?
Q I know you have touched on this matter at a much earlier stage of these proceedings during the course of your evidence, but there is no harm in just drawing a few strands together. Can you be specific, please, in terms of the technique that she was being asked to engage upon at that time as part of this study?
A Certainly. She was being asked to conduct immumo-histo chemistry studies, which required the application of reagents to tissue sections that in this instance were specific, the reagents were specific for a particular virus such as measles virus.
Q In relation to that work, would ethical committee approval be required?
A Yes, it would.
Q Did you have it at that stage?
Q Where was that drawn down from, that EC approval for that set of procedures?
A The approval for the biopsy analysis was actually available under both Professor Walker-Smith’s existing 162-95, but also under 172-96, which by that stage had clearly been approved.
Q Dr Wakefield, looking therefore at the period of just over a year, September 1997 to early 1999, what did you believe during that period that the Legal Aid Board money of £25,000 was being spent on?
A I am sorry. Could you repeat the period again?
Q September 1997 through to early 1999.
A The Legal Aid Board funding was being spent, as designated in the original costings protocol, on the salary of a laboratory technician and the reagents for conducting immuno-histochemical analysis.
Q How did the financing, for example, of the reagents take place?
A What would happen – and this pertains to all grants, all research grants – is that the technician orders an item from a catalogue from a supplier, an invoice is raised, the details of the reagent are sent initially to me and signed off and that is then submitted to the medical school or the trustees for payment.
Q Did that system appear to work without problems?
A Yes, indeed.
Q During this period – and of course if you need to get your bearings, you can look at D8 again – all these children had been investigated by February 1997 and we are now in September. Were you aware during this period that we are looking at that there had been no clinical costs arising in respect of the 12 Lancet children?
Q Did you believe that the expenditure as you have just described on Ros Sim’s salary for the purposes of Legal Aid Board work was within the authority as you had been told of it back in August 1996?
Q As far as you were aware, did Ros Sim work on that Legal Aid Board pilot pretty well throughout that period which I have taken, the two bookends of September 1997 and early 1999?
Q May I ask you, please, to take volume 3 and turn to page 1054? On 26 January did you write to Richard Barr and enclose, as you describe it, the final interim report to the Legal Aid Board?
Q Summarising, as you say:
“ … our findings to date in children with developmental disorders, and their potential relationship to the MMR vaccine.
Please would you arrange for the final payment of £25,000 to be paid to the Special Trustees of the Royal Free Hampstead Trust.
We need now to define the parameters for our future investigations …”
There are three things I want to ask you about. First of all, what was the nature, just in general terms, of the final interim report to the Legal Aid Board?
A It contained broadly two elements. It contained a synthesis of the results that we had obtained from the laboratory and the work of Ms Sim. It also contained a broader, generic summary of the hypothesis and the work from other groups which lent credence to this hypothesis in support of the possibility that MMR vaccines may be associated in this instance with autism.
Q Again, if it is necessary to do so we can look at the document, but why did you think it appropriate to describe it as a final interim report as of January 1999?
A Again, the field was evolving very rapidly at the time and so I looked on these very much as living documents. As new scientific observations came into the literature then I aimed to update that report on behalf of the Legal Aid Board to capture that.
Q From your standpoint, the Legal Aid pilot that you had agreed to undertake to Mr Barr, was that pilot complete?
A Ideally it would have been complete with the peer review and publication of a paper that contained the results of our analysis. As I mentioned last week, Dr Horton himself has said, “If it’s not published, it doesn’t exist” and therefore, if it were to withstand scrutiny in a legal arena, ideally it should have been published. To that extent you are subject to the whim of the reviewers, and you must satisfy the reviewers. By that stage, the paper had not been published. Nonetheless, we felt that the scientific approach to it had been robust. In fact it turned out to be the most detailed controlled study of measles virus using this technique that has ever been attempted or conducted but certainly I was happy that the laboratory work relating to this study was now complete.
Q Just going back to the letter at page 1054, you therefore seek from him for a further payment of £25,000 to be paid. The original authority – I will not bother to ask the Panel to turn up the page again but you will remember it. It was volume 1, page 183 – was for a maximum cost of £55,000. You had had £25,000. The question here is, on what basis were you asking Mr Barr to arrange a second payment, and why £25,000?
A At the end of the first year’s study – and this goes back to some of the description of immuno-histochemistry that I gave last week – we had completed an analysis using what is called a polyclonal antibody. That is a reagent specific for measles that binds to a number of different measles virus proteins. We felt that this was a rigorous study and provided an answer. Nonetheless, when it was submitted for peer review the reviewers came back and, not unreasonably, said, “You need to conduct further work using monoclonal antibodies”; that is antibodies, reagents, that bind to a single measles virus protein which, to their way of thinking, were inherently more specific. To this end we contacted the World Health Organisation reference laboratory on measles virus in Lyons, in France, and obtained from them four standardised measles monoclonal antibodies provided to them by expert laboratories from around the world. So Rosalind Sim’s work continued into a second year, initially characterising those antibodies, selecting two of them as being adequate and applying those to the same tissues in a similar way to determine whether the results were reproducible or not. A series of other specificity studies were conducted, and by the end of that two year period we were satisfied that the original results that we had obtained had held up.
Q The further £25,000: please tell us. What was the basis, the purpose of that money, in terms of its expenditure, if you got it? What was the purpose of the expenditure? On what?
A It was a reiteration of the first year’s funding. It was for the salary costs for Rosalind Sim for the second year and it was, in addition, for the reagents that she would require to conduct the analysis. You will note that it is not the balance of £55,000 but simply a reiteration of the first year’s funding.
Q The balance, of course, would have been £30,000?
Q Did you think, again looking at it prospectively, that that further work would last up to a year?
A Yes, I did.
Q Going back to the letter at 1054, what did you need when you used the phrase “We now need to define the parameters for our future investigations…”?
A The work that we had done had looked for measles virus protein. Sophisticated technology was then becoming available for the detection and characterisation of measles virus genetic material. It was something that we used in our lab but something that we were not particularly expert with, particularly with the newer, more sensitive technologies. It was time at that stage to move forward and answer the question, “We know the protein may be there. Is the gene there and, if so, can we characterise it and distinguish the natural virus, the wild-type virus, from the vaccine strain virus?”
Q Dr Wakefield, it may be very obvious to everybody else in the room except me, but nonetheless it is important. In the context of a potential medico-legal study, a Legal Aid Board study, what was the importance in going forward of the distinction between the presence of protein as opposed to the presence of the gene?
A The presence of the protein was of interest, given the fact that we knew of the children’s exposure. Some children had had measles, some children had had the vaccine. Nonetheless, the technique of immuno-histochemistry does not allow you to distinguish between the natural virus, the wild-type virus and the vaccine strain virus. In contrast, the molecular technique – polymerase chain reaction, PRC – does allow you to do that.
Q That is the acronym, is it, PRC? Was that what Ros Sim was going to be deploying in year two?
A No. In fact by that stage we had identified an expert in the technique who had a technology that was superior to ours and that was Professor John O’Leary in Dublin. The aim at that stage was to set up a collaboration with him to take it forward.
Q Would that still involve a role for Ros Sim? I am sorry – I am just dealing with the position going forward as from January 1999.
A It may well have done, but from that point onwards I did not require any further funding from the Legal Aid Board for her.
Q As of 1999, what was the funding that you were seeking for the Legal Aid Board going to be paid for? Which individual was the salary for?
A Right. I was not seeking further funding beyond that point. Any request for funding would have come directly from Professor O'Leary laboratory.
Q But this second tranche of Legal Aid funding was to be spent on whom?
A I am sorry – that second tranche was retroactive. In other words, she had worked for the second year in arrears and it was the Legal Aid Board who wanted a report before they would make that second tranche available.
Q If we look at page 1055 we see the interim report which was sent to the Legal Aid Board. There is another document at page 1079. I will come back to those in a minute. Did you send a copy of that report, or rather did Richard Barr send a copy of that report, to the Legal Aid Board. Turn back to page 1053.
Q Yes, he did.
Q So you gave it to him and he sends it to the Legal Aid Board?
A Yes, attached to this as referenced to in the interim report was a copy of the results sent to The Lancet as well.
Q Mr Barr has by now changed firms. He is now working out of a firm called Hodge Jones & Allen, not Dawbarns. In the second paragraph:
“We have separately put in a request for the second instalment of the fee for the preparation of this report.”
Would you like to comment on the way he put that to the Legal Aid Board?
A It is slightly odd. I think what it refers to is the requirement of his firm for an interim report before releasing the second year’s funding.
Q Can we just look briefly at this interim report please. We see at the beginning of 1055 a section of 1067 that I would like you to look at please, and comment on. I am not going to read the whole of this out, but I am just taking this particular page for a purpose. Is that of particular relevance to the Legal Aid Board and in relation to the release of the second tranche of the money?
A Yes. This is a brief summary of the immuno-histochemistry, yes.
Q And what is the status of the document at 1079 and 1080?
A This refers back to how one might approach this problem from here on. This is something that has been drawn up in discussion with Professor O'Leary in a very brief summary document suggesting a way forward which seeks to use his technology to detect the virus, to say where it is in the tissues, to determine how much virus is there and to characterise the virus as being wild strain or vaccine strain.
Q We see the nature of the technology at page 1080. I think five lines down you see there a reference there to “… a novel approach to PRC called TaqMan PRC.” Is that the rather more extensive technology?
A It is, and just very, very briefly for clarification to the Panel, the technique for detection of measles virus gene that we had developed at the Royal Free could detect 10,000 copies of the virus in the test tube. Any less than that, and we could not find it. Professor O'Leary’s technique would detect down to one copy of the virus in the test tube, and that made it infinitely more applicable to the investigation of these tissues than the technique that we had developed.
Q Again, looking at 1079 and 1080, was this a “next stage” document?
A It was a proposed next stage, yes.
Q Did you intend that both these documents should go to the Legal Aid Board?
A I believe we did, yes.
Q In respect of this second tranche of money, were you in close contact with Richard Barr from time to time?
A Yes, we were. We talked regularly and particularly I talked with his scientific assistant, Kirsten Limb.
Q Did he know why you wanted the second drawdown?
A From my perspective, yes he did. We kept in regular contact. We discussed the state of the science and where we had got to. He understood that ultimately the requirement was that we were able to pass muster by getting these data peer reviewed and published. In the event, that required him providing a further year’s funding.
Q Did he know that no clinical costs had been incurred?
A Yes. Again, for reasons outlined last week, that would have been self-evident since these would have been billed on an individual per item basis had they been incurred. No costs were incurred. No invoices were raised and therefore he did not have to pay out anything for those.
Q What did you understand, if anything, that Richard Barr would do when he addressed the Legal Aid Board in connection with your request for the second tranche?
A I think that he would have kept them appraised of the situation, and I am sure he did that. I have no reason to suspect that he did not, and I have heard nothing – at least during the proceedings – to suggest that he did not. The Legal Aid Board had made the award. It was a pilot study. I need to just clarify that. A pilot study directs the way in which you should go. You are taking a very, very complex issue and steering a course through what are effectively uncharted waters. You may reach some blind alleys, so you have to turn back. Nonetheless, you are treading carefully, meticulously, through this unknown area and it directs where you should go inherently in that. There has to be some flexibility and to the extent that I thought the first year’s funding would answer the question I was wrong, and it required a second year’s funding. I am sure Richard understood that. Ultimately we were able to provide the answer that was required.
Q You mentioned a few minutes ago and, indeed, referred to it on Friday, I think, the question of the system whereby individual invoices might be raised. Let us just look again at the position that Mr Barr was aware of, for your comment. Would you go back to volume 1, please, at page 340. I want to ask you formally whether you had seen these documents at the time. When did you first see them?
A During the conduct of this hearing.
Q With that caveat, I want you to just look down in the third paragraph of this letter from Ms Cowie to Richard Barr dated 9 December 1996. It is the fifth line down:
“You will also need to let me know which of your clients are taking part in Dr Wakefield’s study. No doubt you will recall that we discussed this at one point in the past as to whether those individual legal aid certificates should be amended and if so in what terms. I think what I am getting at is whether the individual certificates of the children who are taking part in the study should bear some or all of the costs involved in testing them individually.”
She goes on:
“… I am not sure what the answer to the point is, whether individuals should have their certificates amended and bear the brunt of the costs incurred or whether because the outcome of the study will potentially affect all legally aided individuals whether the costs of the individual testing should just be borne by all on a pro rata basis.”
Then at page 360, Mr Barr replies to Ms Cowie on 8 January 1997. I take you down to the fifth paragraph.
“As the financial limit on the individual certificates is quite high might I suggest that the individual certificates bear the cost of the individual testing (stay in hospital, MRI scans etc) and then the generic certificate bears the cost of the overall look at the chosen cases, the setting up costs and the global report when it comes through. Does that make sense?”
I should just ask you for formality’s sake, did you ever see that letter?
Q So far as the subject matter is concerned in the letter, is that subject matter the topic that you had mentioned to the Panel earlier in the course of your evidence?
A Yes. That accords with my understanding.
Q Was that an understanding that you had at the time from Mr Barr?
Q Go back, please, to volume 3. On page 1082, I just run through this in terms of the chronology. We see that the Legal Aid Board received your report. Is that right?
Q Will you turn back to page 1081, please. The Legal Aid Board then authorised the second tranche of moneys payable to Hodge Jones & Allen?
Q Then, would you move on to page 1121, the £25,000 was then paid by Hodge Jones & Allen into the account G106 on 31 March. I will identify that in a minute for you. Would you look just over half way down. You will see the date and the notation “Hodge Jo” and the sum of £25,000. Then turn back a page to 1120. This is a ledger relating to account number G106. Do you see the reference there, half way down?
Q We are, of course, aware of all this. Did you have any knowledge yourselves of all the accounting arrangements within the Trust at that time?
A No. I had no knowledge of the specifics at all.
Q In respect of the second tranche, where did you think, if at all, the second tranche would go?
A Into the account to which I had requested the first tranche to be paid into. That is the only account I held there, the one that paid Ros Sim’s salary.
Q So that, is this right, if your assumption was correct and had been carried through, the same account would have received both sets of money from the Legal Aid Board?
THE CHAIRMAN: Dr Wakefield, once again you are still under oath and still in the middle of giving evidence.
(The Panel adjourned for a short time)
MR COONAN: Dr Wakefield, we had reached the point where in real time terms the second tranche of money had been paid into the Special Trustees’ accounting system by Hodge, Jones & Allen at the end of March 1999. You told us that you instructed Ros Sim to commence work on the Legal Aid pilot at about the time the money became available in principle – in other words, September 1997.
Q Between September 1997 and January 1999 did she work on Legal Aid Board pilot work full time?
Q That period is longer than one year when you say there was the application for the second tranche. When the Special Trustees received the second tranche at the end of March, had she continued to work on Legal Aid Board pilot work?
A Yes, she had.
Q Going forward after the end of March 1999, did she continue to work on Legal Aid Board pilot work, at least for a period?
A I would have to look at the diaries. I do not know precisely when she stopped working on that and moved on to other things, but around that time.
Q It is a simple arithmetic point.
Q Two years’ worth in terms of time, would take one up to September 1999? Here you had two years’ worth of money?
Q Can you help the Panel then about marrying the two up as regards your mind at the time?
A Yes, again it comes back to what was considered to be the state of completion of the work. Sad to say that the papers that derive from that work have still yet to be published and to that extent I have not fulfilled my obligation to the Legal Aid Board, but that is not under my control; that is under the control of the reviewers of medical journal. Nonetheless, she continued. She conducted two years’ worth of work on behalf of the Legal Aid Board under that funding arrangement.
Q Have you any doubt about that at all?
A No, none.
Q Is that what you believed at the time to be the case?
Q Did your receive or have expended or deploy monies from the Legal Aid Board which were outwith the authority originally granted?
A Towards the end of the first year, we had obtained a series of results which we thought were extremely interesting, and at that stage I had been informed of Professor John O’Leary and his technology. John O’Leary had been involved in the detection of a virus called human herpes virus 8 in patients with Kaposi’s sarcoma. He had developed technology which had assisted greatly in that. At the time Professor O’Leary was working at Cornell University in New York and I made arrangements to go to see Professor O’Leary to discuss with him the interim results, to ask him for a critical appraisal of whether he thought the data were of interest or not, whether they stood up to scrutiny, and indeed whether he would be prepared to come on board as a collaborator in the evolution of this work in progress. Part of my remit to the Legal Aid Board was to take this forward and to have it subjected to rigorous scientific scrutiny. To that end, there were travel expenses to America for the purpose of meeting with Professor O’Leary to pursue this work. I saw that as being entirely in line with my obligation to the Legal Aid Board and in the spirit of the agreement to conduct a pilot study.
Q So, putting the question directly, was there any aspect of this Legal Aid Board work that was carried out either directly by you or on your behalf which was outwith the authority?
A Not according to my understanding of the authority, no.
Q Can I just turn by way of background so the Panel can follow the parallel accounting system, and I will just ask you for a comment here and then, first to page 1138? As a matter of fact, it would appear that the Special trustees paid Ros Sim’s salary between April 1998 – we can see on the top left-hand corner—and the notation “Sal;Sims” down to October 1998 at the bottom of the page, again “Sal;Sim”. Did you know anything of their internal accounting arrangement at that time?
A Nothing at all.
Q When did you first see these documents?
A As far as I remember, the first time I have seen them has been during the course of this hearing. I will have been sent an account from the Special Trustees on a regular basis, but it will have been a summary of expenditure and I do not remember having seen these specific documents.
Q Those payments were out of the Special Trustees’ general funds. Going back to 1124, we can see at the top of the page that this is account number 106. From November 1998 – you see the first entry down – “Sal;Sim” and running through. I am not going to take you to all the entries, but if we go through all these pages, pages 1124, 1128 and 1129, one can do it at one’s leisure, it demonstrates that Ros Sim was being paid out of G106 for her salary, where we see the notation “Sal;Sim”. Do you accept that as a fact?
Q Again, did you have any knowledge of the internal accounting arrangements at the time?
Q During the relationship that you had with Richard Barr and the Legal Aid Board – I put it in that way generally – where did you see your obligation in terms of communication and information supplying? Was it directly to the Legal Aid Board or was it to Richard Barr?
A No, it was directly to Richard Barr.
Q Dr Wakefield, did you manage, and I am putting this compendiously, your dealings in respect of the application for funds and the receipt of funds and the management of funds, in so far as you were managing them, and did you deal with those honestly?
Q Did you deal honestly with Richard Barr about these matters?
Q Did you deal – I use the word indirectly in the light of your evidence – albeit indirectly with the Legal Aid Board honestly in respect of these matters?
A Yes, I did.
Q Did you spend any money, any public money, to which you were not entitled?
A No, I did not.
Q I want to leave accounting matters for a moment. I want to ask you about another dimension to these matters. I want to ask you, please, who knew of your involvement with the Legal Aid Board. First of all, did your line manager know?
A Yes, Roy Pounder knew.
Q When was it that he came to know?
A I approached him initially, as I did Dr Peter Harvey, in relation to the amount that an expert would charge in such circumstances acting in litigation.
Q Thereafter did Professor Pounder know that you had in fact agreed to act on a continuing basis?
A Yes, he did.
Q Did he know about the existence of the Legal Aid pilot study?
A Yes, he did and he was the one who recommended the transfer of the funds from the medical school to the Special Trustees for the purpose of conducting that study.
Q Leaving aside Professor Pounder and Dr Harvey, let us look at those at the medical school who might have known. First of all, did people at the medical school know?
A Yes, they did.
Q Did Professor Zuckerman know?
Q Did Dave Wilson know?
Q Did Mr Tarhan know?
Q Is there anybody else you can think of at the medical school who knew?
A Not within the medical school – Bryan Blatch who was at the time the medical school secretary.
Q I should have asked you about him. You are quite right. Now, turning to the Trust, who at the Trust knew?
A Mr Phipps knew and Mr Else knew.
Q Of your clinical colleagues, did Professor Walker-Smith know and if so what of your involvement with the Legal Aid Board?
A There was one very specific circumstance in which Professor Walker-Smith became aware, not of the full details but in the context of a single child, JS. The situation arose that had been anticipated, albeit unlikely, and that is where the doctor, in this case a community paediatrician, had declined to refer this child, albeit that it was felt by Professor Walker-Smith that he needed investigation on a clinical basis. Those were the circumstances in which money was available if that child had a Legal Aid certificate to pay, for example, for the clinical investigations such as MRI or an overnight stay or a colonoscopy. In the end, those funds, the Legal Aid Board funds, were not required or not used to pay for those investigations, and indeed, and it is entirely fair to Professor Walker-Smith to say that he was, I believe, reluctant to use such funds. In the end, the hospital I think picked up the tab for that.
Q Let us pause and consider the position of JS. It may be helpful if you have the Royal Free Hospital notes volume for JS and could you turn to page 71. (Pause while file located and document shown to witness) That is a letter from yourself, Dr Wakefield, dated 16 April 1997. The clinical behavioural aspects I leave to one side. In the fifth line down you say:
“There is legal aid funding to pay for his investigation which I appreciate you will need to discuss with DL”.
Then on page 76, we go back to note the position in November 1996 and you say on the third line:
“JS has been awarded Legal Aid who will pay for the investigations and this is [in] hand.”
Is that right?
Q There is a typo there. The rest of the documentation as I say for the moment I am not concerned with. What do you say is the high water mark of those observations in those two letters?
A I think two things really: one is the fact that there was every intention, in the appropriate circumstances, of using that funding for clinical investigations as and when it was necessary. In the circumstances, ultimately it was not necessary in the case of any child and therefore the Legal Aid Board were never charged and were aware of that. The second is that there was no secret. It has been suggested that this issue was a secret. It was not a secret in any manner at all and this is made evident in this correspondence.
Q Quite apart from those references in November 1996 and April 1997, was the question of you acting as an expert in litigation ever raised with your clinical colleagues?
A We had a meeting in January 1997 where the issue was discussed. My clinical colleagues were, in fairness, very reluctant to become involved in litigation in any form. I perfectly appreciated that.
Q Who was present at the meeting?
A My memory is that Professor Walker-Smith and Simon Murch were there. I will be advised or corrected but I do not remember specifically who else was there. I believe others may have been there.
Q I am not going to ask you to speculate or guess. If you cannot remember, just tell us.
A I cannot remember.
MR COONAN: I am going to ask you to produce an exchange of correspondence relating to this discussion. We have numbered this to go into the chronological bundles. There are numbers on the bottom of the coloured sheets. (New bundle handed and marked) Dr Wakefield, the first document is a letter dated 3 February 1997. Was that a letter from you to Professor Walker-Smith?
Q It is a direct reference to a meeting of Tuesday 21 January. I am going to ask you this time, rather than me, to read it. Would you be so kind as to read this out? It is your letter.
re: Enterocolitis and regressive autism
Further to our meeting on Tuesday 21 January, I thought it important to write to you to clarify my role in the legal issues. I fully appreciate your desire not to become involved in the legal aspect of these cases, but I feel that it is important to express the reasons that I do feel obliged to become involved.
The future for the children with whom we are dealing is very bleak indeed. Not only are the provisions for these children within the community inadequate at present, but looking ahead to the future, there will come a time when the parents of these children die, and the patients, as chronically disabled adults, left to fend for themselves in an extremely hostile world. Were there any long-term institutions left for such children, then that is where they would end up. Since these hospitals are being closed on an almost weekly basis around the country, these hopeless individuals will be left to ‘care in the community’. One does not like to imagine how it will all end. Maybe their only hope is in people taking the possible organic basis of their disease seriously enough to investigate it and institute the appropriate therapies where possible.
Vaccination is designed to protect the majority, and it does so at the expense of a minority of individuals who suffer adverse consequences. Although the case against MMR is far from proven it is one that we are obliged to investigate in view of the consistent history given by these patients’ parents and by the observations made in the United States. If this disease is caused by the MMR vaccination, then these children are the few unfortunates that have been sacrificed to protect the majority of children in this country. If this is the case, our society has an absolute obligation to compensate and care for those who have been damaged by the vaccine for the greater good. This is an inescapable moral imperative and is the principal reason that I have decided to become involved in helping these children pursue their claims. I have considered this issue in great depth and, whilst it may not be the wish of others within the group to become involved, it falls to me to make sure that their legal cases are presented in the best possible light. Fortunately, this is entirely consistent with best clinical practice which, I believe, you are providing for these children. I felt it important, however, to let you know of my feelings on this, and the position that I feel I am obliged to adopt to support these children. Without our help, I genuinely believe that the medical profession would otherwise put them to one side, as it appears to have done in many cases already. My present fears for these children are much less than the horrible imaginings if they do not receive the appropriate help that is due to them at this stage. However, I am an optimist, and I believe that this project will turn out to be both enlightening and rewarding for all those who have been involved, and I am most grateful for your help and encouragement.
Kindest regards & best wishes,
Q Did Professor Walker-Smith reply to your letter on 20 February 1997, with a copy to Dr Murch?
Q Can you read that out to us, please?
Re: Enterocolitis and Regressive Autism
Many thanks for your letter of 3 February concerning the legal issues. I can exactly understand your position and I can appreciate the compassionate human side of your argument.
My position as with measles, MMR and Crohn’s disease is that the link with MMR is so far unproven. It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest. I myself simply will not appear in court on this issue.
I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation.
I am very excited by this work and it is very worthwhile. Simon Murch and I met today and have drawn up a draft for patient selection for your comment please.
I also feel that Dr Harvey’s contribution to the study should now be concluded and Dr Andrew Lloyd-Evans asked to join us. Do you agree with this?
With Kind Regards
Q Was that the exchange between you in relation to the raising of the issue in January of that year?
THE LEGAL ASSESSOR: Can we cross-reference this draft for patient selection? Is that something which is already in the bundles somewhere else?
MR COONAN: It is not Dr Wakefield’s letter, that reference. I am going to ask him about a number of features in the letter. Obviously we can ask Professor Walker-Smith about it.
THE LEGAL ASSESSOR: The only reason I ask, Mr Coonan, is that I know the Panel are, as they get documents at this stage, cross-referencing something they have already read. So if somebody did know whether we have already seen it, it would be helpful.
MR COONAN: We will do what we can. (To the witness) Just looking at your letter first, in the first couple of lines of the letter you say you thought it important to write to clarify your role in the legal issues. What had been the nature of the discussion about legal issues at the January meeting?
A I have to confess, I do not recall them precisely, but it was in essence an expression of my intention to act in this capacity and the concern, the genuine concern, of my colleagues about becoming involved in litigation. The summary was that it was something that I would deal with and there was no need for them to become involved beyond that point. I would take responsibility for that particular aspect.
Q Did you recognise and understand the reluctance on the part of Professor Walker-Smith and/or Dr Murch to become involved in litigation?
A Absolutely. Their concerns were entirely genuine.
Q In relation to Professor Walker-Smith’s letter of 20 February 1997, having received that letter, did you remain understanding and appreciative of his position?
A Yes, indeed.
Q If we look at the second paragraph of that letter, please, he says:
“It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest.”
What did you understand that to be referring to?
A This was now referring to events beyond the conclusion in February 1997 of what was to become The Lancet paper. These were studies in relation to 172-96 and beyond.
Q Again, we will in due course, have a date for when the paper was submitted to The Lancet, but without me pulling out further documents, can you remember now when that was, when the paper was first submitted?
A It must have been prior to the middle of July 1997.
Q In the third paragraph, Professor Walker-Smith makes the point that he had not been confronted by litigant parents of research work in progress. What did you understand him to be referring to when he used the term “research work”?
A This would have been in relation to the laboratory research aspects of 172-96, viral detection work, for example.
Q Finally, Professor Walker-Smith makes the suggestion that Dr Harvey’s contribution to the study should now be concluded and Dr Andrew Lloyd-Evans asked to join. He asks for your agreement on that. Did you ever give it?
A Yes, I did. I think this came about as a result of a suggestion from Dr Mark Berelowitz and I went to Dr Andrew Lloyd-Evans and asked him if he would participate, whether he would collaborate, and he declined.
Q Was there a particular reason advanced by anybody as to why Dr Harvey’s contribution should be concluded and Dr Lloyd-Evans should be asked to consider joining?
A I think that Dr Berelowitz’s concerns related to the fact that Dr Harvey was not a paediatric neurologist and, despite the fact that Andrew Lloyd-Evans was not a paediatric neurologist, he was a developmental paediatrician and therefore may be able to cast a different level of expertise on the problem.
Q Dr Wakefield, I think you may have dealt with this already, but so that the Panel have your response in the round in the light of your answers, was there any way in which your involvement with the Legal Aid Board was kept secret?
Q I am going to ask you, please, to close volume 3 and go back to volume 1. I just want to do this for the record, please. It is a limited exercise. There is a whole series of letters and I want to know whether you ever saw them or were copied into them at the time. We start at page 245. Just for the assistance of people’s notes, this is a series of letters relating to Professor Zuckerman and the British Medical Association. That is the topic. Page 245. I am not going to read these out, because the Panel have seen them before, unless there is a particular comment you make as we go through. I am not going to rush it extremely, but I shall take it smartly. That is dated 11 October 1996. Did you ever see that document?
Q Page 265 is the reply to that document. Did you ever see that document?
Q Page 372. That is from Bryan Blatch to Dr Armstrong at the BMA and follows the same point through. It is dated 24 February 1997. Did you ever see that document?
Q Then at page 398 in volume 2, a letter dated 13 March 1997 from Professor Zuckerman to Dr Armstrong. Did you ever see that letter?
A No, I did not.
Q Just for the Panel’s note, the letter relates to correspondence with Dr Wakefield referred to in the body of the letter, which is a separate issue and I shall deal with that later. If you would go to page 400, did you see the response from Dr Armstrong?
A No, I did not.
Q Then if you turn to pages 405 to 407, you will see a very lengthy letter. Did you ever see that letter?
Q You have read this document for the purposes of these proceedings?
A Yes, I have.
Q Again, just as a generic observation, do you disagree with the sentiments expressed by the BMA in that letter?
A No, not at all. Had I known about these letters, I would have understood the context of Professor Zuckerman’s concern over conflict of interest, that the Department of Health stood to be sued. That was clearly not my understanding at the time. Dr Armstrong’s response, which I think is entirely appropriate, confirms that not to conduct this work because it might embarrass the government is not a sound moral reason.
Q Page 412. That is another response from Professor Zuckerman to Dr Armstrong. Did you see that letter?
Q There was then a separate axis between Professor Zuckerman and Dr Pegg. We now turn to the next page at 413. Did you ever see that letter?
Q Never copied into this?
Q Page 423, Dr Pegg to Professor Zuckerman. Did you ever see this letter?
Q 425. Ever see that letter?
Q 428. Did you ever see that letter?
Q Again, so there is no doubt about how I have been putting this to you, and I have asked you whether you have ever seen it, were you ever copied into it?
Q Dr Wakefield, I want to ask you now just a few questions please about newsletters. The Panel have seen a series of versions of newsletters prepared, obviously, by Dawbarns. I am not going to take you to them each in turn, but I just want to ask you about those documents generally speaking. Did you have a role in drafting the newsletters?
A No, absolutely not. I had no role in those newsletters at all.
Q Have you examined them for the purposes of this hearing?
A Yes, I have.
Q Do you have a general observation to make about them?
A I think – and they clearly are not my documents and Ms Smith was kind enough to say during the opening few days that I cannot be held responsible for what lawyers might write – they are informative. I think that they are useful to a lay audience. I think they contain errors of fact, and some of the literature – the relevant literature – is missing. Nonetheless, they are adequate for their purposes of informing the clients and interested parties of Dawbarns.
Q There is one document, please, I would like you to turn up. It is in volume 1 at page 375. I have used the term “newsletters”. This is a document which is headed “fact sheet”. Did you draft this document?
Q I am going to ask you to look, please, at JS notes. It is convenient to do it in this context – local hospital records at page 162. It is volume 1 of the local hospital records. (Handed to the witness) Dr Wakefield, do you have both those volumes?
A I have one volume.
Q Do you have local hospital records as well?
A I have the local hospital records.
Q Volume 1?
A Volume 1.
Q And do you have also Panel volume 1?
Q Perhaps you could open both at the pages. The fact sheet document in volume 1 of the Panel bundle at 375 is dated 1 March 1997 in the bottom left-hand corner. Yes?
Q And the one in JS’s notes at page 162 is dated, in the bottom left-hand corner, as you can see “Updated 31 October 1996”?
Q Again, it is not my purpose to examine the content of these documents for present purposes but were either of those documents drafted by you?
Q Dr Wakefield, those are all the matters of evidence I am going to ask you to deal with in relation to the Legal Aid Board, but for completeness can I ask you please to look at the charges. We can start at head 3. We are concerned with heads 3 and 4. Dr Wakefield, it is important that we take our time over this – this is a limited exercise – to assist the Panel as much as possible. If you are not sure of the question I am putting, or you need a few moments to consider the position, do say. First, 3(a) and 3(b) you have admitted. In 3(c) there is a limited admission down to the end of the text, save in respect of the phrase in the brackets. Could you indicate to the Panel, please, the basis on which you do not admit the words in the brackets?
A (Pause) I think this relates to the way in which the prosecution have articulated the Legal Aid Board pilot study, the document that they consider to be the Legal Aid Board pilot study is not. It is the proposed protocol and costing that is for my intents and purposes the Legal Aid Board pilot study.
Q It may be if you consider (i) and (ii) together you will see the distinction which is being made?
A Sorry. Right. Again, the Legal Aid Board pilot protocol is not the document that the prosecution refer to here. I submitted that to Richard Barr by way of information only and for the reasons that I have set out, for example, the use of the term, in the title in (ii), “measles and measles/rubella vaccination”, that should now be clear. This refers to natural measles infection, not to measles-containing vaccines. The Legal Aid Board protocol, as referred to by the prosecution, is correct and therefore this is not admitted. The protocol for the Legal Aid Board as I intended it was the protocol and costings document.
Q Lest there be any doubt about it, can we just turn up the document so you can identify exactly what it is you are talking about. Would you go to volume 1 and begin the sequence at page 104 to 120. What is the correct way, you say, of describing that document?
A This is a document that was put together long in advance – certainly in advance of any knowledge of the Legal Aid Board and was a proposed clinical and scientific study, which was the clinical and scientific protocol intended by my colleagues and by me for the investigation of these children.
Q The prosecution have described that in 3(c)(ii) as the “(‘the Legal Aid Board Protocol’)”. Are they right or wrong?
A They are wrong.
Q The second document at page 121, the prosecution have called that 3(c)(i) “(‘the Costing Proposal’)”. Just using those bare words, are they right or wrong?
A Yes are wrong.
Q What should the correct description be?
A As set out in the title, it is the proposed protocol and costings.
Q At (d) in the charges, which remains unadmitted, the description which begins the narrative uses the description “costing proposal”. Is that an adequate description of the document?
A No, this is the protocol and costings, as previously referred to.
Q Apart from that is the rest of the narrative a matter of conjecture or dispute?
A I do not remember seeing the sum of £57,750. I may be wrong.
Q Leave the maths alone, Dr Wakefield. We will work on that.
A All right.
Q In terms of narrative?
A Again, “disintegrative disorder” I would suggest it was signs and symptoms of disintegrative disorder. Otherwise that is acceptable.
Q Little (e): again, the introductory words are the phrase “The Legal Aid Board Protocol”?
A Again, this section is incorrect, in as much that it applies the wrong label, “Legal Aid Board Protocol”, to what was our clinical and scientific study.
Q And (e)(i) asserts that children who had been vaccinated with the measles or measles/rubella vaccine. Do you take issue with that?
A Yes, I do. Again, as I have explained, measles in this instance refers to the natural measles infection, and measles/rubella vaccine by way of clarification refers to vaccines containing measles and/or the rubella component.
Q Any observation about ---
THE CHAIRMAN: I am sorry. Did you say “measles or rubella component”?
A Measles and/or rubella.
MR COONAN: Any observation about (e)(ii)?
A Again, to the extent that notwithstanding the incorrect stem of (e), signs and symptoms of disintegrative disorder more correctly apply.
Q Gastrointestinal symptoms at ((i)i) – any observations about that?
A No. Again not withstanding the inaccuracy of the stem, that is acceptable.
Q (f): there are two descriptive terms, “Costing Proposal” and “Legal Aid Board Protocol”?
A Again, both of these descriptions are wrong and therefore it is not accepted.
Q (g): I immediately take you to the phraseology “Costing Proposal”. Do you have an observation to make about that?
A Again, as before, this is a protocol and costing proposal, and therefore it is an inadequate term.
Q Apart from that inadequacy, what about the rest of the narrative in (g)?
A The agreement between the Legal Aid Board is not with me; it is with Richard Barr. My agreement is with Richard Barr, and to that extent it is also inaccurate.
Q Would you please look at (h) carefully. Do you have any dispute with that as a fact?
A It is only a question of whether it was paid into an account which was held for the purposes of my research generally or whether the amount was for my research generally. The latter is untrue. It is expressly for the purpose of facilitating the Legal Aid Board pilot study.
Q Again, there is an ambiguity which you address there. Is that right?
Q (i) – as a fact?
A As a fact, that is correct.
Q We move now to paragraph 4. I think for my purposes I am going to ask you, please, just to read carefully to yourself in the light of the evidence you have given to the Panel and tell the Panel whether there is any change to your position that you deny the allegations at 4(a), (b) and (c). Can you just read through them carefully.
A (Pause for reading) I have read it, thank you.
Q Is there any change?
A No change at all.
MR COONAN: Dr Wakefield, that is all I ask you about section 7 of the route map. I propose, with the Chairman’s leave, to deal with section 8.
THE CHAIRMAN: If this would be an appropriate moment to adjourn for lunch, we will do so and return at 1.45, so as not to break the continuity.
Dr Wakefield, I give you the usual reminder that you are not to discuss this case during the break.
MR MILLER: Mr Walker-Smith is not present yet, but we could start without him.
THE CHAIRMAN: We will do so.
MR COONAN: I am now going to turn to section 8. We have to turn back in volume 1 in the Panel bundle to look at page 200. Dr Wakefield, we are dealing with what I have generically described as disclosure issues in relation to the completion of this document. Can I just set the scene in order to ask you these questions? You have told the Panel that in the early part of 1996 you had agreed to act as an expert in the MMR litigation and you had agreed to conduct a pilot on behalf of the Legal Aid Board?
Q We have seen and you have given evidence that Richard Barr in June of 1996 had applied for funding in respect of the Legal Aid pilot.
Q I do not want to turn up the documents again. That is the evidence. By the time of the first date on page 200, you also told us that no award had been made by that date.
A That is correct.
MR COONAN: Please turn to page 209. In paragraph 10 there is the heading in bold type relating to “Substances to be given to subjects” and then a subsidiary question in letter font, “How are the substances for this study being provided, and how is the study being funded?” You gave the answer: “Clinical research at the Royal Free Hospital. (E.C.R.).” You gave evidence about that when I asked you about it in another context last week.
THE CHAIRMAN: For the record, Dr Wakefield, you need to say yes or no.
A I was trying to work out from the inflection whether that was a question or not.
MR COONAN: It is my fault and I stand to be corrected. I think you gave evidence about that phrase but I invite you to reiterate that if you would like. When you said, “Clinical research at the Royal Free Hospital. (E.C.R.)” what was that intended to convey when you made it?
A At the time, the clinical investigation was covered by the process of an extra contractual referral.
Q When this form was completed, did you know that you had been awarded funding by the Legal Aid Board?
Q Did you know that an application had been made for funding?
A Yes, indeed.
Q Did you understand there to be any requirement to record in this document the fact that you had applied for funding?
Q When you did get to know about the award in principle – and we went over this in terms of the evidence and the Panel will know that it is Volume 1, page 185 – were you in London at that time?
A No. When the message came through from Richard Barr, the telephone message that he refers to, I was on holiday with my family.
Q Do you know precisely when you got that?
A I do not but I think we were away for the first three weeks of August.
Q When you came to know about the award of funding in principle – again the letter we have looked at – did you have occasion to go back and reconsider the events in this document?
A No. I should have done and I perfectly accept that I was in error for not doing so. The document in various draft forms had gone around to the people who were ultimately to sign it and the senior investigators for their corrections and approval. The final document approved by everybody, the one that was for signature, went out just prior to my leaving on annual vacation. It was duly signed some time after I came back, and this thing takes quite a long time because others are away at that time as well. When it came back, at that stage with the award having been made, it would have been appropriate to re-read it and identify the fact that that should be now amended but I had no reason to re-read it on the basis that everybody had approved it and it just did not cross my mind.
Q If you had known about the grant of legal aid money at the time you were filling this form in, before you went on holiday, if you had known about that, would you have declared it in paragraph 10?
A Absolutely, if I had interpreted the question appropriately, which still confuses me a little, but had I read that as a requirement for disclosure; absolutely, I have no problem with that.
Q How would you have couched the declaration in relation to the grant of Legal Aid Board funding?
A I think I would have said, “This study is funded in part by a grant from the Legal Aid Board.”
Q What would the reference to “a part” have been?
A The part would refer specifically to the viral detection in intestinal biopsies by immunohistic chemistry.
Q When you actually signed the document for submission on 16 September, I think it is, was there anything which suggested then that you should have been re visiting the content of that document?
A No. In mitigation, the document is one of the most confusing that I have come across. That is not in any way a criticism of Dr Pegg. It is as he said: at the time, this was a process in evolution. It was in its infancy and he had designed this document with the best of intentions but the way that it is expressed under “Substances to be given to subjects” as the main section and then a subsidiary question “How are the substances for this study being provided, and how is the study being funded?” it is tucked right away at the every end of an irrelevant section and therefore easily missed. I believe I have missed it on other occasions.
Q When you, as you have frankly said, did not pick up the fact that by the time you came to sign it you had been told you would be in receipt of monies and did not see the need to record that fact, when you say that to the Panel, can you help us, please: were you acting dishonestly in any way?
A No, not at all. There was no secret about my relationship with the Legal Aid Board, and I would have been quite happy to disclose this source of funding.
Q Were you intending to mislead anybody?
A Not at all.
Q Let us turn to a slightly different aspect of this and that is your involvement in the MMR litigation. It is suggested, as I understand it, that there should have been a declaration by you of involvement in the MMR litigation on this form. First of all, do you accept or reject that proposition?
A I think that suggestion was made in the context of it representing a conflict of interest and I reject that completely. The form is set out expecting certain answers to specific questions and no such question exists. Therefore, since it was not asked, it was not answered.
Q It is suggested that if you look at page 201 under the “Objective” paragraph and in brackets “(eg hypothesis which it is intended to test)” that that fact could or should have been declared there. What do you say about that?
A I do have to disagree with Dr Pegg on this particularly matter. He has asked a specific issue, the hypothesis which it is intended to test. That is a scientific question. By analogy, if one were conducting a drug company trial which was intended to measure efficacy of a particular drug in a particular condition, you might similarly argue that the principal aim of the pharmaceutical company is to make a profit, and that is not in any way pejorative; it is a matter of commercial fact. One would not put in the objective here “to make a profit”. One simply would not do that. This is asking a scientific question, as far as I am concerned, and that is articulated clearly in the hypothesis which it is intended to test, and that is set out very clearly here.
Q As matters stood when this form was completed, did you perceive there to be in fact a conflict of interest between on the one hand what the form was intending to describe, the endeavour, and, secondly, your own endeavour in relation to the MMR litigation?
Q No, I did not. I felt that if in the particular studies that were funded specifically by the Legal Aid Board the source of that funding were disclosed, then the issue of conflict of interest was dealt with.
Q I want to examine with you, please, the applications that you had made before to the Ethics Committee. We can pick up the first on page 94 of volume 1. This document begins at 94 and runs through to 100 and was given the notation 77/96. It is an application on page 94 made by Dr Dhillon and Dr Pegg. On page 95 your name appears. First of all, was this your application?
A This is principally Dr Dhillon’s application and I was a co-worker on it.
Q Did you draft this application?
A No, this was drafted by Dr Dhillon.
Q If you look at page 98 at question 10, a question in exactly the same terms as 172/96, the answer is given: “Clinical Research funds at the Royal Free Hospital & School of Medicine.” Is there any observation you want to make about that answer?
A I think the important thing is that it does not specify a source for those funds in terms of who provided them. What it does is describe how they will be administered through the School of Medicine. Having listened to Dr Pegg’s evidence, it is clear now that this answer would satisfy him inasmuch that wherever the funds came from, if they were administered through the Royal Free Hospital as the special trustees or the Medical School, then that was the information he needed to reassure him.
Q Are you in any way critical of that answer, Dr Wakefield?
Q Let us move on to the next on on page 131. For completeness, I should turn to page 99. Does your signature appear there?
A No, it does not.
Q What role did you have with this document, if any?
A I will have read it over, I imagine, and approved it.
Q Page 131. This runs from page 131 through to page 145. Have you refreshed your memory by looking through this document for the purposes of this hearing?
A I have.
Q This is an application given the number 127-96. Whose application was this?
A This was an application by myself and by Professor Roy Pounder on behalf of Danielle Morris.
Q If you look at page 132, do we see your name and Professor Pounder’s name?
A Yes, correct.
Q Did you have anything to do with the drafting of this document?
A This was drafted by Dr Morris and I will have read and approved it.
Q If you look at page 137, again, we see exactly the same question as in 127-96:
“How are the substances for this study being provided, and how is the study being funded?”
And the answer given is “Wellcome Trust”. Is there any comment you want to make about that?
A Dr Morris has correctly picked up on the question and answered it accurately.
Q I think subsequently, subsequent to 127-96, there is an application at page 270. This is an application given the number 203-96. If you look at the top of page 270, are you the responsible consultant named in this document?
Q If you look at page 273, does your signature appear there?
A Yes, it does.
Q The date of submission is 1 November 1996.
Q Just under two months after 172-96 was submitted.
Q If we go to the question at the bottom of page 272 and the top of page 273:
“How are the substances for this study being provided, and how is the study being funded?”
That is exactly the same question, in exactly the same form. Is there any answer given there?
A There is not.
Q Is there anything you want to say about that?
A This was certainly funded and Nick Chadwick’s salary was funded and that question is not answered, not deliberately; I simply missed it again.
Q Are you able to name the funders of that project?
A I think it was the Stanley Thomas Johnson Foundation.
Q Then if we turn to page 679 in volume, the introductory page is page 676 and this tells us that the application was given the number 22-98. We will look at this again later in another context. Halfway down page 679, exactly the same question is being asked in exactly the same terms. Was this an application by yourself?
A Yes, it was.
Q You give your answer, which we can see. What did you say about that answer at that time?
A Here, the question makes a great deal more sense and I suspect this is the reason that Dr Pegg designed it in this way. It was designed specifically for therapeutic trials, or with drug trials in mind, because it asks, “How are the substances for this study being provided?” and then it describes how the drug is being provided. “How is the study being funded?” and then, “Trial is being funded by charitable donations to the Inflammatory Bowel Disease Study Group”. Again, the source is not identified, but the fact that it is being administered through a group recognised by the Royal Free School of Medicine is clearly adequate for Dr Pegg.
Q Then if you can go into volume 3, please, to page 1094. Keep your finger in that page and then turn back to the covering letter at page 1083. This is 29 May 1999, nearly three years down the line. Is this your application to Dr Pegg?
Q That has been given the notation 122-99. We can see that from page 1084. Dr Wakefield, this was evidence given by Dr Pegg. By now, the form has changed.
Q At page 1094 there is a series of questions. Do you want to make any comment about these yourself, particularly since it is a document that you completed and sent in?
A Section 27 asks specifically if the research is being sponsored by the Medical School. This is an insurance-led question I think, or is it pharmaceutical company sponsored research. The answer to the former is yes, the answer to the latter is no.
Q Then if you turn back again to page 1086, paragraph 4.
A This, to Dr Pegg’s credit, was a much clearer form. Here is a separate section with a specific question, “Who is sponsoring the study?” It is unambiguous, it is not tucked behind another question and it is answered.
Q Are there any questions in that document, Dr Wakefield, about conflict of interest in 1999?
A No, there were not.
Q Let me ask you this. I had forgotten to cover it. When you were completing the 172-96 application form, did you have any guidance notes?
A Yes. There were guidance notes attached to the front of the document. I do not have them any more. I think they were provided by the committee itself.
Q From memory, was there any reference in those guidance notes to conflict of interest?
Q There is just one last document I would like you to look at. Perhaps I could just lay the ground for it. Dr Pegg gave some evidence about the current position in relation to application forms. Have you downloaded what appears to be the current, or near current, EC application forms?
A Yes, I have.
Q Are you in a position to produce those now?
A They are downloaded on to my computer. I do not have them.
Q We have copies, so I can ask you to formally produce them. These will be D2, tab 13. (Same distributed) Can we just look at the structure of this bundle? First of all, I think there is a generic document which is described in the bottom left-hand corner as “NHS REC Application Form”. Is that right?
A That is correct.
Q Running to 20 pages. We can see the little numerals on the bottom of the page.
Q Then the second document is a Royal Free Hampstead NHS Trust document entitled “Guidance Notes”. Then the next document is a Royal Free Research and Development Registration form and finally a research and Development Submission Checklist on the last two pages. Does that conform with your bundle?
Q When you went to download this, just tell us what you did and what this purports to be?
A I went through the document with particular reference to looking at the questions which related to disclosure of funding sources and conflicts of interest, the reference to intellectual property, the emphasis for the medical school identifying intellectual property, and one of the other reasons for these forms having evolved over time is the National Health Service or the hospital seeking to reclaim overheads and expenses for research which historically was conducted on their patients using their facilities, but for which they were getting no approval. So largely the elements to it are an improved emphasis, or an increasing emphasis on the ethical process, largely pursuant to the Human Tissue Act, and secondly, National Health Service structure, which was becoming increasingly aware of its own financial commitment to research.
Q All I am going to do in relation to this is take you to a number of pages and invite you to comment. The first page, page 14 of the first document. There is a question at A58, “Has external funding for the research been secured?” Do you see that?
Q The reply was to tick yes or no. On page 15, we see, “If yes, give details of funding organisation(s) and amount secured and duration”. Then A59:
“Has the funder of the research agreed to act as sponsor as set out in the Research Governance Framework?”
“Has the employer of the Chief Investigator agreed to act as sponsor of the research?”
Then on the last page of this document is the question, “Are there any co-sponsors for this research?” Then A60,
“Has any responsibility for the research been delegated to a subcontractor?”
“Will individual researchers receive any other benefits or incentives for taking part in this research?”
And so on and so forth at 63 and 64. Any observation you want to make about that document?
A No. There are a whole series of new searching questions in relation to funding and in relation to possible conflicts of interest that simply did not exist at the time that I was working at the Royal Free and, most certainly, not in any shape or form like this in the time of 172-96.
Q The second document, the guidance notes. Can I take you to the third page in, please? There is a funding section on the top left-hand corner.
“Where appropriate, please document the potential source of R&D funding, total funding requested, total amount received”
and setting out in code form the various sources. There is a specific reference – the third one down – do you see that?
“Funding requested – provide information on funding to be provided”
Any comment there, Dr Wakefield?
A Yes. This is a prospective question. It is saying “To whom have you applied for funds for this project”. Again, that is something entirely new which was not present in 1996 which asked, “Have funds been provided” or “Who has provided funds for the project?”
Q The last reference is the third page of the registration form. It is 3 of 13 in the bottom right-hand corner, just over half way down. There is a question about funding in box shape, the category and a reference back to the guidance notes. “Name of funding body/source” and “Funding Amount”. Do you have that?
A I do.
Q Again, it may be a matter which is self-evident but you are being criticised for the manner in which you handled the form back in 1996, so it is only right you have an opportunity of commenting on that Dr Wakefield. Taking it as a whole, what do you say about that?
A I think that in 1996 the form was imperfect and my approach to it was imperfect. The combination of those two meant that it was not included. What is required of the form is that the ambiguity is removed. Then it was much more easily answered. There was absolutely no intention to hide that funding. Indeed, I think in late 1996 the fact of the pilot study, the Legal Aid Board pilot study, was in the national media, so there can be no secret of the fact. Nonetheless, it was a difficult and confusing form. It remains that and the current form is very, very much explicit and clear.
Q I want now to turn to the relevant charges. Do you have the yellow document there, please? The first section is a section I indicated to the Panel that I would come back to later. I want to pick it up, please, at head of charge 6(g)(v). I am going to read to you the stem of (g), Dr Wakefield, first:
“g. As a named Responsible Consultant you had a duty to ensure that,
v. you declared to the Ethics Committee any disclosable interest including matters which could legitimately give rise to a perception that you had a conflict of interest;”
That is a general proposition. What would you like to say about it as a proposition?
A I simply cannot see how such a charge can be levied against a form which makes no such requirement. There is absolutely no question in the form that requires disclosures of potential or actual conflicts of interest in any shape, manner or form. It is a document which sets out clear – for the most part – questions which require an answer, and it is not for the individual researcher to make additions in the form for issues that have not arisen therein.
Q Let us move to paragraph 7. In the stem of 7(a) there is an implicit or explicit reference back to paragraph 3(c) to 3(g), and the Panel had your evidence on that this morning, and I am not going to go over old ground. It is the same point of construction – all right? Let us get onto more particular and relevant matters. It is alleged in (b) that:
“(i) … you involvement in the MMR litigation ….”
and leaving aside the reference back and the
“ii) receipt of funding for part of Project 172-96 …
constituted a disclosable interest. Let us just break that down for a minute. Was the involvement in the MMR litigation a disclosable interest at that time?
Q Was the receipt of funding for part of project 172-96 a disclosable interest?
A Not in as much that it was a disclosable interest in the terms of a conflict of interest. There was a question that required answering about the source of funding, and that was a different matter.
Q If I put it in this way: was the receipt of funding for part of project 172-96 disclosable?
Q And the Panel have your evidence on that point. It goes on that your non-disclosure –
“(i) was contrary to your duties to the Ethics Committee …”.
What do you say first of all about the involvement in the MMR litigation? Was that a breach of your duty to the ethics committee?
A Not at all, no.
Q What about the non-declaration for the reasons you have given? Was that a breach of your duty?
A For the reasons I have given no, it was not.
Q The final assertion made is that by reason of the matters that I have traversed, it thereby deprived the ethics committee of information material to its consideration of the ethical implication of that. What do you say about that?
A No. I do not think so at all. As Dr Pegg has pointed out, his concern is that the source of funding has been scrutinised by a body within either the Trust or the medical school, and it had. From my perspective the ethical issue relate to harm, potential harm or other adverse consequences for patients as part of this research. The patients who were taking part in the Legal Aid Board pilot study did so with their express consent for being part of the litigation in the first instance, and being part of the investigation at the Royal Free in the second, so there was no information being withheld from them at all. That is the only ethical issue that might be drawn that one might take into consideration here. So no, I do not accept that there was any unethical or breach of ethical practice.
Q Thank you, Dr Wakefield. That is all I am going to ask you about section 8. Sir, would you just give me a moment to clear the decks?
THE CHAIRMAN: Of course.
MR COONAN: (After a short pause) I am going to move on to the next section which concerns the children, and Dr Wakefield’s involvement with the children. On the index of sections you will see that I am going to start with Child 2. You will be able to follow in crib sheet mode, and from the chronology of referrals and admissions, at a glance where the milestones are. This is D8.
Sir, I am going to start with Child 2. You will need, if I can give you advance notice, the Royal Free notes for this child. I am hoping to stick just to the Royal Free notes?
A (Handed to the witness) Yes.
Q Dr Wakefield, some of the evidence I am going to ask you to deal with you covered in a general way on Thursday of last week but I need to bring it back for the purposes of dealing specifically with this child. We are going to start, please, by looking at page 197 of this bundle. This is a letter from Dr Wozencroft, consultant in child and family psychiatry, addressed to Professor Walker-Smith on 29 June 1995. We will see at the top that Professor Walker-Smith was still at that stage at St Bartholomew’s Hospital. Is that right?
Q The first paragraph we will do to set the scene. Perhaps I can read it.
“I write to ask you to see Child 2 and to express an opinion upon him. I know that his parents have contacted you and your colleague, Andrew Wakefield. The family doctor, Dr Cartmel also wants the benefit of your opinion.”
Dr Wozencroft sets out some of the clinical details which we can all see. For my purposes, please, I want to go back to the background to this letter. In or about that time, did you in fact have contact with Mr or Mrs 2?
A Yes, I did. She phone me on, I think it was, May 19 1995 in my office at the Royal Free.
Q Do you have a clear recollection of the date?
A Having reviewed the correspondence since that time, yes.
Q What did she tell you?
A She said to me, in very clear terms, that her normally developing child had received his MMR vaccine and within several weeks had started to develop regression. He had become glazed. He had started to lose language. He had started to lose eye contact and eventually, after some time of progressive deterioration, he had been diagnosed with autism or atypical autism. I said to her, “I am extremely sorry to hear that,” and I clearly had an interest in possible adverse reactions to measles-containing vaccines at that time. I said, “I work in gastroenterology. How can I possibly help you? I know nothing about autism.” She explained that her child had severe gastrointestinal problems; that he had diarrhoea; that he had bloating; that she was sure he was in pain. Her instinct told her that he was in pain but he had lost the ability to articulate that pain. As turned out to be the case for many of these children, self-injury, sudden outbursts of anger, not sleeping at night, waking very fractious, was a reflection of an underlying gastrointestinal pain. Do you want me to go ---
Q Carry on.
A She explained that she had seen many doctors over the years and her own doctors had been extremely sympathetic. She believed the problem may lie in an abnormality in the bowel. She believed her child had some form of bowel disease which possibly led to a failure to absorb vitamin B12, and that there was a link between what was happening in her son’s intestine and his brain, and that these were linked, and had been linked, for many many years to exposure to the MMR vaccine. She made this association between the behavioural problem and the gastrointestinal problem because at times when his behaviour was worst, then his gastrointestinal symptoms were at their worst; conversely, when his behaviour was relatively mild in terms of its presentation, then his gastrointestinal problems were relatively mild. So she believed that these were not two coincidental events, but these were related, and this sounded entirely plausible. She said that she knew of many parents in the same position as her who also had made an association with exposure to measles, or a measles-containing vaccine, and that she believed that there was an explosion in terms of numbers of children with this particular problem.
Q What effect did that account have on you?
A On the basis that the history from the patients or the patients’ parent is paramount in determining what may be wrong with them, it had a major impact. It was presented in a cool, lucid way. It was coherent. She had clearly thought through the problem very carefully. She had done her research. She had retained the confidence of her doctors, which was not the case for many of these parents. There had been a falling out for various reasons. I felt that at the very least this child deserved to be seen by someone who could shed some light on this. There is a fundamental rule of clinical medicine that physical symptoms have an organic origin until proven otherwise. In other words, many of these parents, including at this time this mother, had been dismissed – “Your child is autistic. They are bound to have these bowel problems”. “Well, they have diarrhoea 12 times a day”. “I am afraid that is just toddler diarrhoea.” “But he is nine years old”. You see, the story did not really stack up. In order to exclude an organic origin for this child’s symptoms, then I felt that Professor Walker-Smith was the ideal person to take a look at this child to determine whether or not that was the case. So I said to her, “It is my opinion, since I cannot personally help you, that you should seek a referral from your doctor to Professor Walker-Smith at Barts to see if there is anything that he might do to shed some light on this.”
Q Did you have any contact at that time with Dr Wozencroft?
A No, I did not.
Q Did you have any contact at that time with her GP, who was Dr Cartmel?
Q Did you as it were leave it up to her to seek out a referral?
A Yes, I did.
Q At that stage, did you discuss the matter with Professor Walker-Smith?
A We were in contact at this stage about the possibility of his transfer or perhaps by that stage the actuality of his transfer. I believe I will have called him and said, “Look, John, I have had this contact and I have suggested a possible referral to you. Are you happy with that? Is that OK with you”, as a matter of courtesy.
Q In the same bundle, if you turn to page 25, on 1 August 1995 following the referral letter that we have looked at, Professor Walker-Smith saw this child in the outpatient department. I am not going to go through the detail of this. I am just using this as a milestone. Did you have anything to do yourself with this outpatient appointment?
Q We just want to look briefly at the position following that outpatient appointment. Will you pick it up at page 196? It is Professor Walker-Smith writing back to Dr Wozencroft who had referred the child. He writes, and I am looking at the second paragraph:
“… there is no evidence of Crohn’s disease which concerned the mother, in view of the possible association between measles and Crohn’s disease. Apparently there has been a gastrointestinal problem in the past and I am writing to the various professionals….. I plan to see [Child 2] again in 2 months time.”
At the bottom of the page:
“…I plan to see him myself again in 2 months time when I have more information available. I have done some routine blood tests.”
It is not copied to you, but did you at that time come to know what the result of the outpatient appointment carried out by Professor Walker-Smith was?
A Yes, I think the mother may have communicated this to me by telephone.
Q Then there is a series of letters all written on the same day, 4 August, beginning at 195 and at 194 and 193. Professor Walker-Smith writes to Professor Warner at Southampton, Dr Bhatt at the Vitamin B12 Unit and Dr Cavanagh at the Chelsea and Westminster (page 193). I just want to ask you about an entry on page 193.
“This child was referred to me by Dr Wozencroft, a child psychiatrist…. I am very puzzled by this child and am interested in your letter where you consider the diagnosis of Vitamin B12 malabsorption……..
The child was referred to me via Andy Wakefield of the Royal Free because of mum’s perception of the child’s illness really began with MMR and in view of the possible link of measles with Crohn’s disease.”
Just pausing there, is Professor Walker-Smith’s summary of the position in your opinion accurate?
A Yes, that is entirely accurate. The referral was via me inasmuch that the mother came to me and I made a suggestion to her that she might contact her doctor for the referral to Professor Walker-Smith.
Q Does Professor Walker-Smith, again in the last paragraph, reiterate the plan to review him again in two months’ time? Can we move on to page 178? There is a block of correspondence from Professor Walker-Smith, all dated the same day, 13 September. The correspondence runs from 178 through to 181 inclusive. Can you have a look yourself again at these letters and I will ask you a question or two about them. (Pause for reading) Did you therefore come to know what Professor Walker Smith’s position was by September 1995?
Q What was the mother’s response to that?
A I think that she was extremely grateful for having seen Professor Walker Smith, that he had gone to the trouble of evaluating her son, that he had written to her physicians or various physicians who had been in charge of him in the past to seek their input, that he had taken some tests and decided that the way forward as to have the Schilling test conducted in an expert centre, and he had made the offer to remain involved or at a future stage if that as deemed necessary.
Q Did you have any active role at all in this period in relation to this child’s care?
A None at all.
Q How frequently were you seeing Mrs 2? By that I mean having contact with here?
A Our communication was by telephone and it related in particular to the possible mechanism of the disease. Most of her correspondence with me was about the possible medical basis for this condition rather than specifically about her own child, although she would clearly talk about him from time to time.
Q These last letters were in September. I am going to fast-forward now to May of 1996. We pick up a reference at page 165 from Professor Walker-Smith:
“Dear [Mrs 2]
I think it would be very helpful if I saw [Child 2] again. I have had discussions about [him] 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 the outpatients and discuss and plan what we have in mind. I have arranged an outpatient appointment for… Friday, 14th…”
I just pause there. In fact the outpatient appointment was on 21st, but to more substantive matters: what discussions had you had with Professor Walker-Smith about Child 2 in the intervening period?
A The discussions that I had had were against a background of a large volume of possible referrals of children with a similar story coming through and, as I described last week, the construction of a working or provisional draft clinical protocol and the adjunct research attached to that for the investigation of these children.
Q The adjunct research, was that an activity or an endeavour that you were to carry out?
A That was my endeavour and it was in relation to the biopsy material. The priority throughout this process was defining a clinical mechanism for investigating and caring for these children. So there was the intention, as has been referred in that letter as a plan for investigation, and this was set out in the way that many clinical protocols are set out.
Q Professor Walker-Smith had been at the Royal Free now for about seven months. Is that right?
Q How enthusiastic was Professor Walker-Smith about the underlying nature of the clinical investigations?
A I think we all, Professor Walker-Smith and his team given their experience, saw the clinical imperative for investigating these children. There was an unresolved issue and they were in a position as experts to potentially shed some light on that.
Q There was an outpatient appointment, as I have said, on 21 June. We can pick that up at page 28. In fact there is a stamp on the top of the page for Dr Murch. Are you familiar with the writing of Professor Walker-Smith and Dr Murch?
A I am.
Q Whose writing is that on that page?
A This is Professor Walker-Smith’s writing.
Q On 21 June he sees this child. I take you to the bottom of the page, penultimate line, where he has written: “Arrange admission with Dr Wakefield.” From your standpoint, why might Professor Walker-Smith be making that reference?
A Can I come back just a fraction because I think I failed to answer one of the earlier questions about contact with Mrs 2 in advance of this?
A Just to say that Mrs 2 had remained in contact with me but had called at around that time to inform me that her child had undergone significant clinical deterioration, progressively worsening diarrhoea, progressively worsening behaviour. I think at that time she had also seen Dr John Hunter, who is an adult gastroenterologist in Cambridge. He had intended I think to put her on a probiotic treatment, trying to boost the beneficial bacteria in the intestine. One of the things that he noted was in fact at that time one of Child 2’s inflammatory markers was raised, considerably raised, the erythrocyte sedimentation rate, and this at that point would have been consistent with inflammatory bowel disease or a similar inflammatory condition. So, having been appraised of that by the mother, clearly this will have influenced my decision to make contact with Professor Walker-Smith again on this matter. Then, coming back to ---
Q Not at all. Thank you for that. In fact you had referred to the deterioration when you were giving evidence last week. At any rate, we come to the entry on page 28. Why would it come about, from your standpoint, that Professor Walker-Smith would be making that comment that he did?
A It is Professor Walker-Smith’s document and he may have his own interpretation of this. I imagine this is in relation to making sure that my aspects, the research aspects, of our joint clinical and scientific investigation were ready to go, if you like, that I was aware of the admission and was ready to deal with the tissues.
Q Anything more than that?
A Again, it is not my document; I do not think so, no.
Q If you turn on to page 160, Professor Walker-Smith is now writing to Dr Cartmel, the GP, following the outpatient appointment. It is dated 24 June, the clinic of 21st, as we see on the top, left-hand corner. I just ask you this, Dr Wakefield: would you have taken part in the outpatient clinic appointment?
A There may have been an intention at that stage to sit in on the clinics. Whether I sat in on this one or not, I do not know. Did I play any role in it? No, I did not.
Q Looking at page 160,
“As you know I first met [Mrs 2] via Dr Andy Wakefield who is concerned with measles immunisation and possible Crohn’s disease. I think Crohn’s disease is unlikely. Dr Wakefield has the view that there may be some kind of other inflammation which may be a relevant factor in [Child 2’s] illness and we now have a programme for investigating children who have an association with autism and a possible reaction to immunisation. I am arranging for [Child 2] to come in for investigation in September.”
Whose decision was it that Child 2 should come in for investigation?
A Professor Walker-Smith’s.
Q Did you take part in any way in that decision?
A No, I did not.
Q Looking at the body of the letter, has Professor Walker-Smith captured accurately the assertion that you had the view that there may be some kind of other inflammation which may be relevant?
A Yes, I thought there was. In view of the episodic nature of Child 2’s problem, inflammatory bowel disease characteristically waxes and wanes, and his was similar to that. Professor Walker-Smith had previously volunteered the opinion that he may have some form of food allergy or multiple food intolerance, which can certainly be associated with inflammation. I felt that may be accurate and part of what is going on. So, no, what he says here is entirely accurate.
Q If you look at page 163, Professor Walker-Smith writes to Dr Hunter, to whom you have referred already. I appreciate this is not your document, but I just want to ask you about one assertion:
“I would be very interested to hear your view concerning [Child 2]….. Via Andy Wakefield I have been asked to see him to consider doing a colonoscopy and a general assessment as to consider whether bowel inflammation of some kind might be playing a role in his illness, and also performing Schilling Test…..”
Just taking that on the face of it,
“Via Andy Wakefield I have been asked to see him to consider doing a colonoscopy…”
Is there any observation you want to make about the structure of that sentence?
A Once again, I think it is factually entirely correct. It is not, “Andy Wakefield has asked me to do a colonoscopy”. It refers back to the mechanism referral, “Via Andy Wakefield, I have seen…” On this occasion, “Via Andy Wakefield, I have been asked to…” I think that is a reflection of that.
Q Just going back to page 160, Professor Walker-Smith writes on the fourth line:
“….we now have a programme for investigating children who have an association with autism and a possible reaction to immunisation.”
Again, what would you read that as a reference to?
A Since Professor Walker-Smith came into the Royal Free at the end of the last quarter of 1995, as I mentioned last week, we had been together putting together a combined clinical from his point of view, and experimental from my point of view, protocol and that was a long time in the formulation. A great deal of consultation took place with colleagues and experts, both at the Royal Free and around the country, and the culmination of that was the programmed for investigation. This is what he is referring to there.
Q On page 158 Professor Walker-Smith writes to you on 28 June:
“I last saw Child 2. I think he is now the most appropriate child to begin our programme.”
When you received this letter, how did you respond to that?
A I was in full agreement. He was the most appropriate child to begin Professor Walker-Smith’s clinical programme and therefore he was the most appropriate person to enter into any experimental work that I was going to undertake.
Q It may be suggested that this reference – and there are others – is a direct reference to a research programme that both you and Professor Walker-Smith and his team were planning to get involved in. What do you say to that?
A Professor Walker-Smith has been at pains throughout his correspondence with Dr Pegg and with others that these children are being seen according to clinical need. He has said it not once, not twice, but many, many times. There is absolutely no question that the priority and what is embodied in the terms “programme” and “study” as far as the clinical aspects are concerned, is a clinically driven, clinically motivated programme under the guidance of Professor Walker-Smith.
Q Did you believe that it was a clinical programme at the relevant material time?
Q In a word or two, what was the basis of your belief?
A Because of the presenting condition of the children, because of their gastrointestinal and behavioural symptoms and because of the urgent need, the desperate need, of the parents to seek investigation and potential resolution of those symptoms, that was their concern. They wanted to get their child better and that was the primary motivating force for Professor Walker-Smith and his team and indeed myself.
MR COONAN: Sir, I do not know whether you are contemplating taking a short break this afternoon, but Dr Wakefield has been giving evidence for nearly an hour and a half.
THE CHAIRMAN: Yes. I think this a convenient time. We will have a short break and we will resume at 3.30. Dr Wakefield, I give you the usual reminder.
(The Panel adjourned for a short time)
THE CHAIRMAN: Yes, Mr Coonan?
MR COONAN: Dr Wakefield, we were looking at page 158 and I asked you some questions about that. Can I take you now, please, to page 151? This is in terms of timing following the outpatient appointment, but before admission. It is dated 28 August and in fact is addressed to Mr and Mrs 2:
“This letter is to confirm that [Child 2] is to be admitted …. On Sunday 1st September for colonoscopy and Schilling test.
Any further investigations required will be decided on another occasion following consultation with Dr Wakefield.”
Leaving aside what Dr Casson had to say about this for the minute, do you want to make any observation about that? In particular, were any of the clinical investigations going to be decided upon by you?
Q What investigations might have been a candidate for you deciding on them?
A Research investigations related to intestinal biopsies.
Q As it was, was that letter copied to you?
A It does not appear so, no.
Q Then the admission which took place on 1 September. Can you look at page 8, please? Did you have any involvement in the admission process, in other words, the clerking in and so on?
A No, I did not.
Q You have told us that it was Professor Walker-Smith’s decision that he should be admitted. What was as you understood it Dr Thompson’s role? I assume for present purposes that this is Dr Thompson’s writing.
A That is correct. Again, I stand to be corrected on this, but I think there was a rotation in terms of clinical ward duties amongst the consultants. Dr Murch or Professor Walker-Smith may correct me on that, but it appears that on this occasion Dr Thompson has seen Child 2 on the ward and has taken the initiative in light of his condition to make contact with Dr Surtees, who Child 2 has seen before, particularly in respect of discussion of cerebrospinal fluid analysis.
Q Just remind us. What was Dr Thompson’s specialism?
A He was a paediatric gastroenterologist.
Q There are a whole series of clinical notes following on pages 9 through to 18 in respect of this admission. As you understood it, during this admission, were you to be carrying out any research?
A If colonoscopy was undertaken, which it was, then biopsies would be taken, which were then available for analysis in my laboratory, yes.
Q In respect of the various investigations of a non-laboratory nature, who took the decision that those investigations should be carried out?
A It appears that these were taken by the senior staff, the consultants in the Department of Paediatric Gastroenterology.
Q Did you have any role in decision-making there?
A None whatsoever.
Q I just ask you this generically. In respect of these investigations, did you believe they were or were not clinically justified?
A One has to see this against the background of the level of consultation that had taken place to get to this point. Here you have three senior consultants: Professor Walker-Smith, Dr Thompson and Dr Murch, each having discussed this with other clinicians at other hospital and with other clinicians within the Royal Free, and so there can be absolutely no doubt in my mind that they were clinically indicated.
Q Did you believe that at the time?
A Yes, I did.
Q There is one document which I would like to ask you to look at. Can you turn on, please, to pages 351and 352? I want you for the moment to put to one side the existence of the handwriting on the document and imagine that as a sheet of paper with just the typescript on it. Have you seen that document before?
A Yes, I believe I have.
Q In what context have you seen it?
A This is the clinical protocol from Birmingham Children’s Hospital introduced by Dr Mike Thompson.
Q Is there any of your writing on this document for Child 2?
A No, there is not.
Q In relation to these entries, who would you expect would be completing them?
A This is, as Dr Casson has referred to, a checklist, if you like, a ward protocol which allows the junior staff to tick off those tests that they have been instructed by the consultant staff to undertake.
Q In particular, one of the investigations carried out was a lumbar puncture. We see a reference to this on page 18. There undoubtedly are other references to it, but I just want to put this down as a marker. Halfway down page 18, under the heading “Ward Round”, there is a reference to MRI, sleep EEG, LP and arranging for a Schilling test. As far as you understand it, whose decision was it that a lumbar puncture should be carried out on this child?
A This would have been Professor Walker-Smith’s decision.
Q Did you have any role in that decision that a lumbar puncture should take place?
A None whatsoever.
Q One of the issues – and we will see it time and time again – is an issue in relation to what I am going to call the sequency of the various investigations. Whose decision was it that the investigations should be done in one or other sequence or order?
A This was a joint decision arrived at by the clinical consultants participating in this clinical research programme.
Q Did you take part in any of what I have called sequencing decisions?
A No. That was not my role.
Q Following on from that, there is an entry at page 10 during this admission – the date is slightly cut off – in September:
“Ward round, Dr Thompson, senior registrar to Dr Harvey – bleep. Asked to come and see”.
Then on page 13, over to the top of page 14, Dr Harvey’s name at the top. Is that his writing?
A It is.
Q The date appears, if you read it in the normal English way, to be December. Can you help about the date?
A I have never seen the date written like that before, I have to confess.
Q Can you help one way or the other about the date? Again, I am not trying to complicate matters, but the American way of doing dates is to reverse the month and the day.
MS SMITH: I am sorry to interrupt Mr Coonan, but I have to at this point, just to say that this witness has said that he has not seen before and he cannot explain the date.
MR COONAN: I do not think there is any issue about this.
MS SMITH: I have no idea, since I do not know what point you are trying to make, with respect. It does not seem to me to be a question that Dr Wakefield can answer, whether there is an issue or not.
MR COONAN: Again, I do not want to set hares running, but if you look at the next page at the top, the end of that note is immediately preceding a date in September. I am just trying to be helpful. However, Dr Wakefield, if you cannot shed any light on it, you cannot. End of story.
A I think the only thing I can say is that on page 12, Dr Harvey’s senior registrar says at the end of his clerking:
“I have suggested to Mum – I could bring Dr Harvey to see [Child 2] on Monday at around midday.”
That may shed some light on it.
Q Thank you very much. At any rate, were you aware at that time that Dr Harvey had or had not any particular role in relation to this child’s lumbar puncture?
A Yes. To the extent that Dr Harvey in the construction of the clinical protocol advocated lumbar puncture and investigation of these children, in addition to Dr Thompson introducing the Birmingham Children’s Hospital protocol. So to that extent, he was involved, yes.
Q Would you turn on to page 19, please? It would appear that this child was readmitted in November for colonoscopy. If you look at the top line of page 19. Do you see that?
Q Did you have any role to play in the decision to admit him for colonoscopy in November?
Q Would you look at Professor Walker-Smith’s summary of that admission on page 140? This is following the second admission from Professor Walker-Smith to Dr Cavanagh at Chelsea:
“ … we investigated [Child 2] for evidence of Crohn’s disease. I had been, as you may remember, somewhat reluctant to do this in 1995 but more recently in view of [Mrs 2’s] concern that his gastrointestinal symptoms and his general symptoms may be related to MMR, we went ahead and did a colonoscopy.”
He sets out the evidence as he saw it in his opinion. Is the basis upon which Professor Walker-Smith appears to go ahead and do a colonoscopy in any way surprising to you?
A Again, it is not my document and Professor Walker-Smith will have his own thoughts on this, but there is no doubt that Child 2’s clinical condition had undergone marked deterioration prior to the revision by Professor Walker-Smith of his previous decision to conduct a colonoscopy on this child. So whatever is written here, there can be no doubt that clinical deterioration is the indication for at least assessing him again.
Q I just want to flag up another document which is not your document, and it is at 247. This is a document signed by Dr Murch in relation to the colonoscopy and this is the September date. You can see on the right-hand column the time and entry, “History: disintegrative disorder”. Then, half way down:
“This colonoscopy was performed in the further investigation of disintegrative disorder, and was in fact abnormal.”
Obviously Dr Murch can speak for himself, but from your standpoint, do you have any comment to make given on the one hand the nature of the investigations you believed to be taking place clinically and on the other your research work?
A This document does not contribute or is not influenced by any aspect of research. The history of disintegrative disorder is entirely consistent with the information that we had received from Dr Berelowitz and his team that this child’s loss of skills and onset of gastrointestinal symptoms most likely accord with a diagnosis of disintegrative disorder. Again, I cannot really shed any light on the performance of a colonoscopy exclusively in this indication.
Q On page 18 of the clerking notes we saw a little earlier reference to the MRI, and EEG. Just remind us again, did you make any decision in ordering those?
A No, I did not.
Q I want now to look at evoked potentials and you have to turn back in the notes, but to page 257. There are three documents, 257, 258 and 245. Let us take, please, 257 first. On the face of the document – forget the written entries for a moment – which is it? What is the nature of the document?
A This is an order form for the department of clinical neurophysiology in order to get an electroencephalogram performed.
Q And can you identify which is your writing on that document?
A It is all my writing except where it says “Visual evoked potential – VEP; brain stem auditory evoked potential – BSAEP” and above that, “somatosensory evoked potential – SSEP”.
Q What about the ticks in the box?
A The ticks are mind.
Q The ticks are yours? What about the test number on the right hand side?
A That is not mine. That is put in by a member of the department.
Q What about Child 2’s names and date of birth?
A I have added the name and the date of birth.
Q On the next box, Dr Harvey’s name and Malcolm Ward and the date. Are those in your writing?
Q The reasons set out and the signature: are those yours?
A Yes, they are.
Q There will be some individual questions flowing from this, but Dr Wakefield, what is going on here with this document?
A As I mentioned last week, in accordance with the protocol that had been drawn up, and in light of the considerable added workload for the paediatric gastrointestinal team, I had offered in a purely clerking role, a purely administrative role, to arrange these tests if they ordered them – and if they ordered them. Since my office was close to the department of electrophysiology I filled in the form for that test. In fact, before these investigations started I went to each department that was involved in it – it was just for my own clarification – met with the head of the department in order just for me to try and understand what kind of clinical information might be gained from such an investigation in a child with autism, and it was most instructive. I told them when we would be requesting such investigations, when I would be arranging them and then they would be given the notification “Disintegrative disorder” so that the head of department would recognise them. That is what it amounts to. This role is now undertaken by a ward clerk and does not require a doctor to arrange. It requires a doctor to order the test and that is the role in which I was acting as a clerk.
Q You appreciate the allegation here. It says you either ordered or requested the tests.
A Yes. I made no clinical executive decision in ordering these tests at all.
Q What about the “Reason” box? What is asked for here is the reason for the request, the relevant history and current medication.
A The reason for the request was in accordance with the information that we had been provided with by Dr Berelowitz, that is of disintegrative disorder, or a likely diagnosis of disintegrative disorder, needed to be excluded and a likely part of the background in terms of the possible vitamin B deficiency which, for their purposes, can be reflected in abnormal conduction because the insulation of nerves in the brain, myelin, is abnormal or potentially abnormal.
Q Did you intend to convey the existence of a positive diagnosis of disintegrative disorder?
Q On page 258, any comments you want to make about that?
THE CHAIRMAN: I think there is hardly anything I can actually see on page 258. It is a very poor copy.
MR COONAN: that may be the basis of the comment being alluded to. Dr Wakefield, you heard Dr Kumar’s observation. There is a typed statement on the top.
A And that is helpful if the Panel can see it. It says “Conclusion – A normal study”. It is reassuring, and we see reproducible responses in the visual evoked potentials of appropriate latency. That suggests that when there is, for example, a flash of light and the time for that flash of light to be recorded in the cortex of the brain, when there is an abnormality on myelination of the conducting material, if you like, the insulation of the nerves, then that may be prolonged. That latency period was prolonged in this case.
Q I have completed the document at page 245. Is that the report of the EEG. You see the number 3710?
Q Is that to be read as linked with 257?
A I think that is a reasonable assumption, yes.
Q Thank you very much. I want to ask you about a separate topic. Will you turn to page 143. This is a report from Dr Mark Berelowitz dated 30 September addressed to Dr Murch.
“Thank you for asking me to see [Child 2] who I saw on the Ward on the 5th September 1996. I saw him at the request of yourself and Andy Wakefield, for the purposes of learning more about possible links between his presentation and measles vaccination and bowel disease, but it was not intended that I should have clinical child psychiatry responsibility for him.”
Looking at that paragraph, please, did you in fact ask Dr Berelowitz to see this child?
A No, I did not. Again, this requires some explanation. What I had undertaken to do was to let Dr Berelowitz’s secretary know when this child was going to be on the ward so that he could organise to see him. The referral came, quite appropriately, from the paediatric gastroenterologist – on this occasion Dr Murch. There are two distinct processes here. One is a formal clinical referral from a clinical colleague, and the other is me making contact with his secretary to let him know that the child was on the ward. This sort of minor error of fact occurred several times in the early part of seeing these children. Then you will notice that these letters, referring to referrals by me, letters from Dr Berelowitz, disappear from the correspondence.
Q We will examine those as we go through it. So there is not any doubt about it, was this in any sense a clinical request by you?
Q On the subject of clinical involvement or otherwise, can I just deal smartly with two or three points. In 1998, and you will find this at RF36. On 18 February 1998, there is a stamp at the top of the page at RF36, which says “Wakefield Clinic”. Is any of that your writing?
Q Did you have a clinic in your name?
Q Did you attend this clinic?
A I may well have done, yes.
Q Leaving aside the actual stamp, did you have any clinical role, even on the basis that you attended it, at all?
A None at all.
Q What would have been your role at that stage?
A In the clinic, my role was purely one of an observer, there to learn and to try and understand the basis for these children’s problems in order to articulate relevant hypotheses for investigation.
Q That was in 1998. We just go back, now, to page 92. You will see a letter from Professor Walker-Smith to Dr Cartmel, the GP.
“I review [Child 2] in the outpatient clinic with Dr Wakefield.”
Do you dispute that?
A No, not at all.
Q Again, what would have been your role being with Professor Walker-Smith ---
A I was there as an observer. I am sorry?
Q --- in the outpatient clinic?
A I was there as an observer.
Q Of course, this was a year after his first admission?
Q A general matter which applies in some of the other children, but I will take it now on the 142. This is a letter relating to an outpatient clinic following his first admission. The letter to Dr Beattie, at Peterborough, from Dr Fell, is copied to you. It is a letter relating to treatment to enteral nutrition. What interest would you have had in the topic of nutrition in October 1996?
A Nutritional therapy, and particularly the polymeric diet, has in Professor Walker-Smith’s hands and Dr Murch’s hands been shown to be a highly effective treatment, initially experimentally and now clinically, in the treatment of inflammatory bowel disease. It could be Crohn's disease in children. Therefore this has both a clinical element to it, and a research element to it and it was extremely interesting. The outcome was recorded and sent to me – copied to me – by Professor Walker-Smith.
Q Can I ask you this globally. In relation to the management of this child, both on an outpatient basis and an inpatient basis, did you have any active involvement in the management of this child clinically?
Q What were your activities confined to?
A My activities were confined initially to acting as a signpost for the mother, to get clinical help for her child, and therefore listening to her insights as the mother of a child and also an investigator, if you like, in her own right into a possible cause of her child’s problem in order to take those forward, if plausible, in a scientific context.
Q I want to run through almost coming to the end of this, following the structure of the heads of charge, beginning at head 9. I am going to take them by topic rather than just slavishly following the charges. If members of the Panel want to turn them up, then well and good. First of all, as far as you were concerned, was what was taking place in relation to Child 2 a research programme?
Q At the time investigations were carried out, was ethical approval required for those?
A No. I am sorry, can I just go back? In respect of what I was doing or ---
Q You are quite right to pick me up. In respect of what Professor Walker-Smith and the others were doing?
A No, absolutely not.
Q In respect of what you were doing?
A In respect of what I was doing, which was research, then ethical approval would have been required, yes.
Q Did you have it?
A Yes, I did.
Q Which was?
A Under 162/95.
Q Did the start date, which we see in the approval letter from the ethical committee dealing with 172/96, have any relevance to these matters?
A No. As I mentioned to the Panel last week, the error has been the conflation of the first 12 children with 172/96. They are not and never were part of 172/96 and therefore that date did not apply. One observation I might just make in looking at I think it was page 18 is that you will see a reference to lumbar puncture and a line to cytokines. I have already said that cytokines were a research test. I just want to make it absolutely clear to everybody that no cytokines in fact were ever measured in the cerebrospinal fluid of anyone. It is not a test that was ever conducted.
Q Page 18 is the reference. Entry criteria: did entry criteria or inclusion criteria apply to the investigations on this child?
A No, they did not.
Q That is head of charge 9(c)(ii). What about consent forms? Were consent forms from your standpoint required for clinical investigations?
A The relevant consent forms for the clinical investigation, such as colonoscopy, are, I believe, present in the clinical record.
Q Just turn up page 340. Is that what you had in mind?
Q Would a consent form have been required in connection with any work you were doing?
A There was a standard consent form available under 162/95, which I also believe is present in the record.
Q Turn to page 346. Is that what you had in mind?
Q There is an allegation that the various matters that I have covered collectively, and I am putting this in a general way, were contrary to the clinical interests of this child (head of charge 9(h) ). Do you have a view about that, Dr Wakefield? I am not asking you to adopt a clinical mantel but to express a view from your standpoint.
A Yes, I do. Here, as you have heard from this child’s general practitioner, was a highly complex problem; a child who was extremely unwell and who, despite the attention of a large number of clinicians from various disciplines, remained an enigma and continued to suffer. Through the process of due clinical care, Professor Walker Smith and his team provided a clear insight not at least part of this child’s problem – inflammatory bowel disease of some sort or another – which, once diagnosed appropriately, was then amenable to therapeutic intervention. I do not know what the outcome for this child would have been if that bowel disease had not been diagnosed and treated, and I wonder if we had identified this disease earlier in the course of his life whether the outcome may have been better. The prognosis may not have been quite as hopeless. Nonetheless, everything that was done for this child in complete agreement with his mother and his attending physicians was done in his best interests.
Q I have two other short matters to deal with. When it came to the drafting of The Lancet paper, can we just identify together the materials that you would have had available? First of all, would you have had the referral letters?
Q Would you have had the clinical notes generated at the Royal Free, including correspondence to and from the Royal Free?
Q Would you have had the clinical histopathology documentation generated by the histopathologist including Dr Davis?
Q Just simply to illustrate the point, and I am not going to do this with each and every one of these children, perhaps we could just set the scene for what you mean by that. If you look at page 248, would you have the endoscopy report?
Q A histology written on the right-hand side?
Q Then if you turn on to 263a running through, with the exception of 269 (slightly out of order) but down into 270, would you have had all those documents, and 270a?
A Yes, I would. One thing I would say just by way of clarification is that the information in The Lancet paper was based upon the first colonoscopy and the first histology and some of the information that comes up here is from the November colonoscopy and histology.
Q I am not for the moment attempting to fine-tune anything; I am just dealing with the general principle.
Q Would you have had the product of any Friday afternoon amendments in the notes?
Q We have heard about the role of Dr Dhillon. Did you have the product of Dr Dhillon in relation to this child prior to the drafting of The Lancet paper?
A Yes, indeed; Dr Dhillon’s detailed research, overview, in the pro forma driven format that I have talked about last week was available and in fact was the final determinant of the diagnosis in these children.
Q Just for completeness, would you take volume 7 of the Panel bundles, and look at tab 16? In general terms, what is tab 16?
A Some time during the course of the investigation of these children it became clear that there was a possible new syndrome emerging, that bowel disease was indeed being found, immunological abnormalities were being found. By way of our training in academic medicine, which is largely pro forma driven and database driven, it was felt appropriate to develop a system, albeit rather primitive at the time, to make sure that all the relevant information was being captured. This is not necessarily a research exercise, although it can be; it is a way of making sure that you have ticked the boxes, that you have captured the relevant information in a consistent way across a group of patients. So this is a pro forma or these are draft pro formas in various states of preparation the design of which was mine. What I have attempted to do in this is to capture the salient features of his child’s history, the demographic information, their infancy, their childhood development, their infectious and vaccine exposure, their histology and so on and so forth.
Q Did it include the product from Dr Dhillon?
A Yes. If you turn to page 243, you will see an example of the histology pro forma that I mentioned to you. Now this is a summary pro forma. Each individual biopsy, and there may be seven or eight of them from the colon of a particular child, has one page like this. You will see the designation down the left hand column of: acute inflammation, chronic inflammation, epithelial or laminar propria changes, et cetera. These are just histological matters of interest. Then across the top, if there were none of these features of interest present, there was a zero score. If they were present and mild, then a score of 1, moderate 2, severe 3, and then a total score given. This is Dr Dhillon’s contribution to his work. This was done in co operation with Dr Andrew Anthony.
Q Very briefly, last of all, can you take volume 1, please, and go to page 265d. This is the legal aid certificate granted on 18 October 1996 – you will see that half way down the page – in respect of Child 2.
Q Did you become aware at any time that Child 2 was in receipt of a legal aid certificate?
A Yes, I did.
Q When was that?
A I do not remember specifically but I do know that Child 2’s biopsy was included in the legal aid pilot study.
Q Was Child 2 one of the Legal Aid Board five?
Q More particularly, round about the referral time and the admission to hospital, can you help the Panel whether you were aware at all, either way, of any particular motivation by Mrs 2 in relation to litigation?
A Litigation was not even mentioned by Mrs 2 prior to the admission and investigation. It did not even appear on the radar, and this is starting way back in May 1995 right the way through until her child had been investigated, and it most certainly to my mind had no role in motivating her.
MR COONAN: Thank you, Dr Wakefield.
Sir, that completes my examination in relation to Child 2. I am sorry I have run on a little bit but I thought it better to complete Child 2 tonight.
THE CHAIRMAN: Yes. We will finish for the day now. I know it has been a long day for us and particularly for Dr Wakefield.
Once again, Dr Wakefield, please do not discuss this case overnight.
(The Panel adjourned until 9.30 am on Tuesday 1 April 2008)