GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Wednesday 2 April 2008
Regents Place, 350 Euston Road, London NW1 3JN
Chairman: Dr Surendra Kumar, MB BS FRCGP
Panel Members: Mrs Sylvia Dean
Ms Wendy Golding
Dr Parimala Moodley
Dr Stephen Webster
Legal Assessor: Mr Nigel Seed QC
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 1
THE CHAIRMAN: Good morning, all of you. Good morning, Dr Wakefield. Mr Coonan, you are in the middle of examination in chief.
MR COONAN: Sir, that is right. Thank you.
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued
Q Dr Wakefield, we finished yesterday afternoon by looking at Child 6, and we were looking particularly at the general practitioner notes and we had reached page 123. Can we go back to that, please, just to provide the platform for this morning’s evidence. In the chronology we had reached the 4 October 1996, prior to the admission of Child 6 to the Royal Free Hospital. If you now turn to page 121, for my purposes this is all I am going to look at in relation to the main part of the admission. We can see on the right-hand side the admission date on this document, 27 October 1996, although I should just say for the record there is a counterpart document in the additional records at page 37 which indicates the admission was on 25 October. No matter; I shall work on the basis of this document. In relation to the admission the procedures are there summarised on the right-hand side: colonoscopy, MRI, lumbar puncture, VER and EEG. Did you have any role to play in this admission?
Q As far as you understood it, who was responsible for any decision as to whether this child should undergo any one or other of those procedures summarised on the right-hand column?
A Professor Walker-Smith.
Q Did you have a view at that time as to whether or not the procedures – and I am just taking them compendiously – were clinically justified or not?
A They were clinically justified in my opinion at that time.
Q So far as the order in which any of these investigations were done – whose decision was that?
A That was a matter of consensus between the clinical consultants.
Q Did it involve you in any way? Any input from you?
Q As matters then stood in relation to these investigations, did you view those investigations as being research investigations or clinical investigations?
A They were clinical investigations.
Q What research, if any, did you do in relation to this child either during or after the admission?
A The research was the performance of examination in the laboratory on the biopsies taken during the routine colonoscopy.
Q Was that the same as with the other children that we have looked at so far?
Q One of the procedures on page 121 was the EEG. We can look at this more particularly at page 160, but not of that bundle. You will have to go into the additional records. Would you go to page 160, please? We see on the top right-hand corner at test number. We see the EEG box ticked and the fourth box down, the writing. I think that is “VEP”. Is that right?
Q Is any of the writing on that document yours?
Q We see against “Request Source Consultant/GP” – does that read “Prof JAWS”? Is that right?
Q Then over the page at 161, a different test number now – F3962. The content of the document is, of course, self-evident. Is any writing on that document yours?
Q And to complete the picture, at page 162 there is a report in relation to the VEP request. Is that correct?
Q With Dr Sherratt the reporter. Will you turn on in the same bundle, please, to page 39? The photocopying is very poor, but you will see towards the bottom of the page – if I have this annotation wrong I shall be corrected but I think it reads:
“2 November. See – for routine examination. Letter to follow. L Berelowitz.”
Did you have any direct involvement with Dr Berelowitz himself in relation to any examination of this child?
Q With that entry in mind, I would like you now, please, to turn to the Panel bundle, volume 2. I want to turn to page 605d and 605e-f. I think from memory page 605e and 605f were put in on Day 37.
THE CHAIRMAN: Yes, indeed. I think they were actually put in, if I remember it correctly, by Mr Hopkins.
MR COONAN: That deals with the preliminaries, Dr Wakefield. Can we look at 605d first, please. It is a letter from you to Mrs 6, and it is dated 6 September 1997, so quite some time after the note that I have just shown you in the additional records.
THE WITNESS: I am sorry. Which page are you on now?
MR COONAN: Page 605d.
THE WITNESS: I am sorry. Yes, I have it.
MR COONAN: It is September 1997. The letter is in relation to Child 6 and Child 7.
“Further to our conversation the other day, I am writing to confirm that following assessment of your children at the Royal Free, in particular by Dr Berelowitz, the Consultant Child Psychiatrist, the behavioural diagnosis in [Child 7] is of a developmental disorder on the autistic spectrum between Asperger’s and autism.”
And this is what I am concerned with because we are dealing with Child 6.
“The diagnosis for Child 6 was likely to be Asperger’s Syndrome.”
Can you remember how it came about that you had a conversation with Mrs 6, as this letter says, “the other day”?
A She will have called me following the discharge of both Child 6 and Child 7, and I would imagine, in the absence of having received a communication about the behavioural diagnosis that Dr Berelowitz had arrived at, and this may well have gone directly to her family doctor, Dr N, and I was merely confirming what had been identified clinically by Dr Berelowitz by way of responding to her request for information.
Q If you turn the page at 605e we see a report from Dr Berelowitz dated 3 June 1997. Is that right?
Q And although the heading relates to Child 6 and Child 7, the report in fact is solely in relation to Child 6?
Q And it is copied on page 605f to Dr Simon Murch, signed by Dr Berelowitz and on the first page, as I say, dated 3 June, addressed to you. The body of the document I am not concerned with, but it is the preliminary part that I want to ask you about. First of all, it is addressed to you, and Dr Berelowitz says in the first two lines:
“Thank you for referring [Child 6] to me. I saw him on 11th November 1996…”
Again that is a reference, is it not, to page 39 of the GP records that I showed you earlier?
“… but I see from my records that I did not write to you about him.”
This letter again, in exactly the same way as has occurred before, says, “Thank you for referring 6 to me”. What was the mechanism of connection between you and Dr Berelowitz at that time?
A Firstly I had absolutely no role in making a clinical referral of any child to Dr Berelowitz and, once again, my role was in an administrative capacity, to inform Dr Berelowitz’s secretary that these children would be coming to the ward in order that he could put an appointment into his schedule.
Q I am just going to pause for a minute because in the charges, if you have the yellow sheet there, if we go to head 16(f), that is a factual assertion which was not admitted by you at the outset of the proceedings.
MR COONAN: 16(f).
THE CHAIRMAN: Mr Coonan, 16(f) is about Child 5.
MR COONAN: No. It is Child 6.
THE CHAIRMAN: Yes. I think you are right. I am sorry – I was looking at the wrong page.
MR COONAN: Dr Wakefield, do you have that?
A I do.
Q You can tell from the text in front of you, I think, because that remains a factual assertion which is not admitted.
A I can see that, yes.
Q As I indicated and I think it is agreed, the material at pages 605e and f were put in on Day 37?
Q What is your position in relation to 16(f) now?
A It is factually correct.
THE LEGAL ASSESSOR: If that is accepted, and I am looking at Ms Smith as well, would it be better to have an amendment to the date, to be precise, because it says he saw the child on the 11 November. The charge as it stands says “On or about 1 November”. There does not seem to be any reason to have a ten-day variation.
MR COONAN: No, I entirely agree. I had not spotted that.
THE LEGAL ASSESSOR: Ms Smith, do you agree? If that is now admitted, would it ---
MS SMITH: There is a difficulty about the date. Excuse me for a moment. It may be that Mr Coonan would prefer to leave this and have a word with me about it afterwards than have an argument about the date now. Can I just say, the only reason that we are hesitating over it is because we believe that the date is, in fact, correct – the 1st – not the 11th, as Dr Berelowitz says, because the date of the 1st ties in with the dates when the child was admitted. I am very happy to explain that to Mr Coonan, but he may not want to hear the whole spiel at this particular moment.
THE LEGAL ASSESSOR: I am sorry for wasting time with it.
MR COONAN: I am grateful to Ms Smith. I understand the point entirely and I am grateful to the Legal Assessor for raising it. I had not spotted that there was a potential discrepancy in the dates, but it does not matter for the purposes of the flow of the evidence. The principle Dr Wakefield accepts, the narrative of the allegation in 16(f). All that remains is to have a discussion, as Ms Smith says, about the precise date and I am more than happy to leave it until later on and not to burden the Panel with it now.
THE CHAIRMAN: So you are going to take this later on?
MR COONAN: Absolutely. (To the witness) You can put the yellow documents away, Dr Wakefield, and you can also put the Panel bundle volume 2 away. Could I ask you to go back to the additional records? I would like now to look with you at a number of other events and pieces of correspondence which post date the admission so that you can tell the Panel what your role was or was not. The first document is at page 13 of the additional records. On 17 April 1997 Professor Walker-Smith writes to you following a clinic, according to the top of the letter, the day before on the 16th. He writes:
Re: [Child 6] …
This is just for the record to remind you that [Child 6] is on Olsalazine in a dose of 250mg three times a day. I am just starting his brother [Child 7] on this because although the histology of the rectum was normal, he did have lymphoid nodular hyperplasia and it is at least worth a therapeutic trial as there is a continuing problem.”
Of course, we can ask Professor Walker-Smith about these matters from his standpoint, but from your standpoint, why might you be interested in knowing the nature of the medication for Child 6?
A By this stage, in light of our collective experience with the improvement, the response of the intestinal inflammation and in addition the response of some of the behavioural characteristics of these children’s problems to treatment with standard anti inflammatory medication prescribed by Professor Walker-Smith and his team, it seemed sensible to start contemplating a controlled clinical trial. In other words, seeking to put this into a scientific context to determine whether this treatment was truly efficacious or not. My role and the role of the research liaison nurse, Miss Thomas, was to make a note of who was receiving anti inflammatory medication and indeed to stay in touch with the parents to determine whether there was in their opinion at least clinical improvement in their children. What Professor Walker-Smith is doing here is bringing it to my attention, because I may not have been in this particular clinic, that this child is going to be receiving anti inflammatory medication for his inflammatory bowel disease and that I should be aware of that and Miss Thomas should stay in touch with the parents to determine whether there is a response.
Q Underlying that correspondence is this question, can I pose to you, please? In terms of that interest and the receipt of the information, were you acting in a clinical capacity?
A No, I was not.
Q Can you put that bundle to one side, please, Dr Wakefield, and take the GP bundle and go to page 371? This is a letter which Professor Walker-Smith wrote to Dr N in January 1998, 12 January, following a clinic on 9 January. As the beginning of the letter indicates, Professor Walker-Smith had reviewed Child 6 again in the outpatient department. What follows is self-evident and I am not concerned with that. He says at the end of the major paragraph on page 372:
“However, I do think in fact that further follow-up should be done locally rather than here as basically we have nothing further to offer diagnostically.”
Then in the last paragraph, he says:
“Dr Wakefield will be in touch in due course about the results of research and if there are any new problems emerging I would be happy to see the child again or to give further advice about constipation. For the moment I have not given a further outpatient appointment to be seen again in this Clinic.”
That is copied to you. Does Professor Walker-Smith’s statement there to the GP find agreement with you, or not?
A Yes. This letter capture perfectly the respective roles that Professor Walker-Smith and I had in the investigation of these children. Professor Walker-Smith’s first several paragraphs convey a purely clinical message; his investigation, his clinical investigation and treatment of these children is now complete, the treatment has been beneficial and Child 6 continues on it and he is making the doctor aware that in my capacity as the lead researcher on this I will be in touch with the doctor or with the parent at some stage with the results of any relevant research investigation.
Q Taking this chronologically means jumping around, I am afraid, because of the state of these records. Can I now ask you, please, to go back to the additional records, page 64? We are now on 1 May 1998 and we see in the top left-hand corner a stamp which says “Wakefield Clinic”. Whose writing, if you can identify it positively, is that under the clinic stamp?
A It is Professor Walker-Smith’s writing.
Q Did you hold a clinic on 1 May 1998?
Q There are a number of documents which post date the publication of The Lancet paper which I need to ask you about; they are in the documents and you are entitled to make observations about them. If you would now turn back, please, in the GP bundle, to page 161. We are now on 29 January 1999 and Professor Walker-Smith is writing to the general practitioner, Dr N, about Child 6. This letter, as you can see, is copied to you. Professor Walker-Smith, as the letter makes clear, is referring first of all in the first paragraph to the medication and secondly, to the clinic examination, the clinic being on 27 January, as we can see in the top left-hand corner. At the end of the letter, he says this:
“I have made another appointment to see him again but Dr Wakefield will be in touch with the family in due course.”
Leaving aside the question whether or not that did happen, I want to ask you, please, about your anticipation, if there was any, that you would be in touch with the family in due course and, if so, about what.
A In line with Professor Walker-Smith’s last letter to Dr N referring to the results of research investigations, I would imagine Mrs 6 has asked Professor Walker-Smith during the course of this appointment whether those test results from my laboratory are available and Professor Walker-Smith has said that I will be in touch with the family in due course about that.
Q Would there have been any other reason for you to have been planning, even in Professor Walker-Smith’s mind, to get in touch with the family?
Q Moving further along in the same bundle to page 302, this time it is a letter from a Dr Furman, who is a specialist registrar in paediatric gastroenterology. He writes:
“Dear Dr N
[Child 6] …
I saw [Child 6] today together with Dr Andy Wakefield …”
We note the date of this letter is 25 January 2000. Dr Furman rehearses the medication regime and at the bottom of the letter, he says:
“On discussion with Dr Wakefield, we have decided to give [Child 6] an open appointment and have not booked him for repeat follow-up at this point.”
Can you tell the Panel, please, what was in fact happening at that outpatient appointment?
A Certainly. I think that on this occasion Professor Walker-Smith may have been out of the country at a meeting or otherwise engaged and Dr Mark Furman, a junior doctor in the department, will have taken over the responsibility for the conduct of this particular clinic. I sat in with Dr Furman and, given his inexperience in dealing with autistic children, towards the end of the appointment he may have asked me what Professor Walker-Smith would have done in these circumstances with respect to a future outpatient appointment or he may have suggested that giving an open appointment was one alternative and it appears that I have agreed that Professor Walker-Smith would likely do the same in the circumstances and that is what was done.
Q Again, the question may be raised, were you acting in a clinical capacity in any way by being involved in a discussion with Dr Furman in this outpatient clinic?
A Not at all. I was perfectly entitled within my duties to respond to questions and offer an opinion when that was requested and this is just one such circumstance.
Q The clinic note counterpart, which I think in fairness you ought to look at, is in the additional records at page 68. There is a note after the history and after the notation “O/E”. Just remind us, what does that mean?
A On examination.
Q After that, the note reads, “Seen with Dr Wakefield today.”
Q You can put that to one side, please, and go to page 324. In October 2000 Dr N [name given] wrote a letter to Dr Lloyd-Evans asking if Dr Lloyd-Evans could make an appointment to see Child 6 sooner if possible. He says:
“He has been suffering from severe headaches and behaviour disturbance and his mum is very concerned about him. She has brought him to the surgery on several occasions and I note has attended Casualty and Out-of-Hours Service also on several occasions.
Clinically I think he is suffering from severe headaches with no organic cause but I spoke to Dr Wakefield of the Royal Free who suggested I needed to consider diagnosis of sub-acute sclerosing panencephalitis in view of his other presence of measles vaccine virus in his gut. Apparently this has an insidious onset”,
and he signs off in the way set out. Can you remember the circumstances in which apparently you had a conversation with Dr N?
A Yes, I can. In accordance with Professor Walker-Smith’s previous letters I had communicated the results of the laboratory investigations on measles virus detection to Mrs 6 and the biopsies according to those tests were positive for measles virus for the vaccine strain, or consistent with the vaccine strain, to be precise.
She had communicated this information to Dr N [name given] and had also communicated ---
THE LEGAL ASSESSOR: That is the second time. I have written a note for the shorthand writer, but that is the second time we have had that.
THE WITNESS: So sorry.
THE LEGAL ASSESSOR: It is just that we do not want it in the transcript.
THE CHAIRMAN: Also, if there are any new members in the public gallery, in the press gallery, would they make sure that this name does remain anonymous. That is the direction that I did give very early on, but I am just repeating this direction again.
THE WITNESS: Thank you for that, and my apologies. Where was I? She had mentioned to Dr N that her child was deteriorating with possible severe headaches. He called me and asked me if there was any significance that should be attached to this in light of the finding of measles virus in Child 6’s intestine. I said the only circumstance that I know of that one should be aware of, at least to consider, is the possibility of a persistent measles infection of the central nervous system, that is sub-acute sclerosing panencephalitis. I made no suggestion as to how he might proceed with this other than to say – and he has made this clear in his letter, and I will read that:
“….Dr Wakefield of the Royal Free who suggested I needed to consider diagnosis of sub-acute sclerosing panencephalitis …”.
He had requested information from me and I had passed on one possibility to him. I should say that I do know quite a lot about sub-acute sclerosing panencephalitis and I have studied tissues from patients and published papers on this particular disease.
Q Some criticism emerged during the course of the hearing at the last session – and I hope I do not put this too high – but to the effect that you had no business even suggesting that he should consider it. What do you say to that?
A I think one has to consider the alternative, and that is possessed of the knowledge that this child had or appeared to have, according to the laboratory investigations, a persistent measles virus infection, and with the knowledge that persistent measles virus infection is associated with this rare but fatal encephalitis, and possessed of the knowledge that this child had severe headaches and was apparently deteriorating, it would be unthinkable to sit on the end of the phone to Dr N [name given] and not communicate that information to him.
Q Did you transgress the limits of your consultant appointment?
A No, I did not.
Q If we move on, please, to 2001, I think we have to go to the Royal Free notes for this. Do you have those there, Dr Wakefield?
A I think they are on the way.
Q Could you go to page 61, 21 May 2001, a letter from Dr Harvey now to Dr N. He sets out the content of a letter at some length and for my current purposes I am not going to trouble you with the detail of that, but it is the first paragraph that I want you to look at please:
“Many thanks for your kind referral of this young man, who I have actually met before, when I was on the staff of the Royal Free Hospital and I examined him neurologically at the request of my colleague Dr Andrew Wakefield, who was investigating children with autism and the relationship with chronic inflammatory bowel disease. I did not at the time I saw him today have access to my notes from the Royal Free Hospital.”
Can you help the Panel, please, about the basis upon which you and Dr Harvey had a connection in respect of Child 6?
A Historically, and we are now some years down the line, Dr Harvey took part in discussions in the setting up of the clinical and experimental protocol. Again, no formal clinical referrals came in any way from me; these would have come from clinical colleagues, and as you have seen according to the schedule my role was to communicate to Dr Harvey’s secretary that any patient might be coming to the ward in accordance with Professor Walker-Smith’s instructions.
Q Was that arrangement different or the same compared with the arrangements with Dr Berelowitz?
A It was exactly the same.
Q Can I ask you now to look at the GP bundle at page 237. This is a letter from Dr Khan, you will see on page 238, consultant paediatrician in neurodisability, addressed to Dr N, on 19 July 2001 and is in relation to a clinical appointment that Child 6 attended with his mother. The second paragraph is all I want you to comment on:
“He remains on Olsalazine prescribed by [and I put this in quotation marks] ‘Professor A. Wakefield’ from the Medical Unit at the Royal Free Hospital.”
First of all, I think we understand you were not a professor. Is that right?
A Not ---?
Q A professor.
Q Did you ever prescribe any olsalazine?
A I never prescribed any drug.
Q Finally in this run of correspondence up to, as we shall see, 2002, there is a letter in the Royal Free documents at page 49, dated 17 January 2002. Do you have that, page 49?
A I do.
Q It is a letter from one GP practice in East Sussex, Dr Moore to Dr Murch at the Royal Free:
“Dear Dr Murch
RE: [Child 6]…
This nine year old boy was under the care of Dr Wakefield who had been treating him for a bowel condition.”
Has he got that right or has he got that wrong?
A I think it is evident to the Panel from Professor Walker-Smith’s correspondence with Dr N that this is wrong.
Q Dr Wakefield, I am going to turn now to the backdrop of the charges, please, and the live charges begin at head 17. Dealing with head 17(a) and (b) principally, what, as you understood it, research was being carried out during the relevant time?
A Analysis of biopsies taken during the course of his clinical colonoscopy.
Q Any other research?
Q Do you remember the list of investigations that I drew attention to earlier this morning on page 121 of the GP notes. Did you understand those to constitute a research endeavour?
Q In respect of the matters which you have described as research, would you have needed EC approval for those?
Q Did you have it?
Q What was it?
Q Was the concept of a starting date relevant?
Q That is head of charge 17(c)(i). What about entry criteria? Were they relevant?
Q That is head of charge 17(c)(ii) and 17(c)(iii). Consent forms: in respect of the clinical investigations that you have identified, would you expect there to be consent forms for those?
Q Perhaps you could now just go back to the additional records bundle and begin with page 42 of the additional records. What is the status of this document?
A This is a Royal Free Hampstead NHS Trust consent form for a routine investigation, in this case colonoscopy under sedation.
Q Page 45?
A Similarly this is a Royal Free Hampstead NHS Trust consent form for a routine investigation and in this instance MRI, EEG and lumbar puncture under sedation.
Q Would you expect there to be a research consent form for the research element that you have described?
Q To be kept in the clinical notes?
Q Would you turn to page 7, please? What is the status of that document?
A This is a consent form for research biopsies pursuant of 162/95.
Q Would you expect there to be any other consent form for research purposes in respect of this child?
Q Very briefly could I just turn to the question of legal aid, please. Could you just have to hand the GP records and would you turn to page 247? On 15 May 2001 Dr N writes to Dr Harvey in these terms:
“I understand that you are willing to see this child who is known to be on the autistic spectrum disorder and is one of the children who is currently part of the litigation cohort against the manufacturers of the vaccine MMR.”
Assuming for the moment that that information is correct – I will work on that basis – at the time that this child was referred and was being investigated, did you know whether or not this child had a legal aid certificate?
A At the time, no.
Q Did you become aware that he did have a legal aid certificate?
A I became aware that he did not have a legal aid certificate at the time that you referred to in the last question, but he subsequently came to have one, yes.
Q When did you become aware that he had a legal aid certificate?
A I do not remember. It would have been some time after his admission and investigation.
Q Did he end up being one of the Legal Aid Board 5?
A I believe he did, yes.
Q Can I just turn the clock back a little more? At the time of referral or thereabouts were you aware of any particular motivation or belief by the mother?
A Yes. Firstly in terms of motivation, her concern – her overriding concern – was for the clinical well-being of her child. She had a sick child whom she felt beyond doubt had some organic basis for his symptoms and she had been unable to get to the bottom of that. She was seeking our help and, in particular, seeking the help of Professor Walker-Smith and his team in trying to shed some light on what might be going on with her child.
Q Were you aware – again, I am not putting a precise date on this but in general terms round about the referral time – on the part of the mother of any general litigation interest or involvement at the time?
A No. Litigation was not discussed.
Q Finally this. The same format as with the other children. So far as The Lancet is concerned, when you came to play your part in writing it up, what material was available to you?
A I had the full, contemporaneous clinical record and, in addition, I believe some early development records from the red book.
Q Again so we are clear about it, would the clinical records have included the histology and the records? Again, I am not going to take you to them but they were put in during the course of the proceedings. They are in the additional records. Would you have had all those available to you?
A I would, and in addition I would have had Dr Dhillon’s detailed pro forma investigation on the histopathology
Q Thank you very much, Dr Wakefield. That completes Child 6. I am going to move to Child 7. We will need both the GP and Royal Free notes for this.
THE CHAIRMAN: Mr Coonan, I am just looking at the time. I think it is about ten to eleven. Rather than breaking your continuity when you are in full flow, it is probably right that we have our mid-morning break now. Then you can start in twenty minutes’ time. So it is ten to eleven and we will now adjourn and resume at ten past eleven. Dr Wakefield, you are still on oath, giving evidence.
(The Panel adjourned for a short time)
THE CHAIRMAN: Mr Coonan?
THE CHAIRMAN: Sir, thank you. Child 7, the GP records and the Royal Free records, please. Just by way of introduction, Dr Wakefield, we are concerned again with Dr N. I say that with a lot of emphasis in my voice, you understand. Can we start, please, by looking at GP, page 282. Dr N writes a letter to Professor Walker-Smith and the date on the top right-hand corner is either the 3rd or the 5th. We can discuss that later, but for me perhaps either date will do.
“I would be grateful if you could see this boy who is a child whose brother you have recently investigated as part of your programme for colonoscopy for children with autistic problems. He himself probably does not have autism, although this is not certain at present but he does have convulsions which I believe may make him eligible for your study. He also suffers from bowel problems similar to his brother who is autistic.”
As we can see from the letter, that was written directly to Professor Walker-Smith. By way of background to that letter, did you play any role in that referral, leading up to the letter being sent to Professor Walker-Smith?
A No, I did not.
Q And on 5 December, on page 283 – so probably the date on the page before was the 3rd, but no matter – Professor Walker-Smith writes to Dr N:
“Many thanks for your letter. I would be delighted to see [Child 7] and I have arranged for an outpatient appointment to be sent.”
Did you have anything to do with the decision to offer or arrange an outpatient appointment?
A No, I did not.
Q In the Royal Free bundle at page 11 we see the outpatient appointment noted up.
A Could you bear with me a moment? I have lost the first 54 pages of this bundle. (Handed to the witness)
Q Page 11. That is the outpatient appointment of 15 January 1997. Did you have any role to play in that outpatient appointment?
Q Does it follow that Professor Walker-Smith wrote to Dr N? I am going to ask you to go back. Perhaps we could stay in the same bundle. I think it is page 60. There is a cross-reference to the same page in GP 279, for those who are following it, in that sequence. The clinic date on the top of this letter you can see, 15 January 1997. It is written by Professor Walker-Smith and over the page it is copied to yourself. Do you accept that?
Q And going to the body of the letter, it appears to be a summary of what was established at the outpatient’s appointment and in the second paragraph Professor Walker-Smith says this:
“Particularly in view of the findings in his brother, I think it would be appropriate for this child to be investigated particularly by colonoscopy and I am arranging for him to be admitted on Sunday 26 January 1997 and he will be having other investigations as part of the protocol. We will let you know the results of these investigations in due course.”
Two things: did you have any part to play in the decision to investigate this child and, as Professor Walker-Smith says, “particularly by colonoscopy”?
Q The phraseology here at the bottom of page 60 is “… he will be having other investigations as part of the protocol.” On the basis this was copied to you, how would you have read that? What does it mean to you?
A First and foremost that he would be undergoing other clinical investigations as set out in the protocol and in the same way that his brother had undergone, and that in respect of research I would be analysing, or potentially analysing, biopsies should they be procured at colonoscopy.
Q Can you now look at page 85 of the Royal Free bundle? Do you have that?
A I do.
Q The letter we looked at a minute ago on page 60 was dated 17 January and this is dated exactly the same day, 17 January. It refers again to the clinic date and it is written by Professor Walker-Smith to Dr Berelowitz.
Re: [Child 7] …
This child will be admitted on 26 January 1997. He is a sibling of [Child 6] who is already in our protocol. In this case although there are some autistic features, the GP has not referred the child for full investigation. I would be grateful if we could have your quite detailed opinion concerning [Child 7] while he is in hospital as to whether or not he falls within the autistic spectrum and any appropriate investigations could be done. He will be having the colonoscopy on Monday 27 January … and he will be remaining in for the rest of the week.”
Did you play any part in causing that letter to be written?
Q And in so far as Professor Walker-Smith refers to the fact that Child 6 is already in a protocol, what would you understand that to mean from your standpoint?
A That as with the other children, he has been investigated according to the clinical protocol and the direction of the Professor Walker-Smith, and may well have had biopsies analysed by me under the scientific or research aspects of the protocol.
Q I am going to leave that for the moment, but I would ask you and, indeed, the Panel to make a note because we will come back to it later. Pursuant to the arrangements which we have seen in the correspondence thus far, I just want to have a look very briefly, please, at the admission. Turn to page 6 of the Royal Free notes. We can see that he was admitted on 26 January and the author of this note… Again, I do not want you to act as a handwriting expert, but do you actually recognise this writing?
Q In the body of the clerking notes, you see the bottom of page 7, which I think is probably the 27th, there is a reference to a ward round “WR PROF”.
For Bethlem & Maudsley”
barium meal, presumably –
“To see Dr Berelowitz Re autism.
Dr Lloyd-Evans re developments”
MS SMITH: I am sorry. Could we have the whole note read out, please? Mr Coonan inadvertently left out “Wed” for Wednesday.
MR COONAN: I am sorry. “For BAM + FT Wed.” At the bottom there is a coding number of some sort. On that occasion, or indeed the day before, did you have any role to play in any planning for investigations?
Q In particular, did you have any role in any planning that this child should see Dr Berelowitz?
Q Insofar as the various investigations which had been planned to be carried out, were done, as you understood it, whose decisions were they that they should be done?
A Professor Walker-Smith.
Q In relation to the order in which they were either to be done or were done, did you play any part in that?
Q As you understood it, whose responsibility in terms of decision making was it that that should take place in the way in which it either was to or did?
A That was a consensus arrived at by the senior clinicians.
Q So far as the lumbar puncture is concerned therefore, did you cause the lumbar puncture to be carried out?
Q What was your opinion, your state of mind, at the time about the nature of these investigations, taken compendiously?
A That they were clinically indicated.
Q If you stay in the Royal Free bundle and go to pages 157 and 157A, which we can take together, if you look at page 157, do you see the test number in the top right-hand corner?
A I do, but I do not have page 157A.
THE CHAIRMAN: I do not think we have 157A either.
MR COONAN: Perhaps copies could be made of that. (Same distributed) Do you have that now, Dr Wakefield?
Q If you look at the top right-hand corner of page 157, do you see the test number and also in the top left-hand corner of page 157A. Do you see that?
Q On page 157, looking at the test number and the date, are those in your writing?
Q Is the rest of the writing on that page, 157, yours?
Q You have ticked the EEG box and you have ticked the EP box. Can you just read for us your writing alongside the EP box?
A Yes. “Sensory, B-S”, which is brain stem, “auditory and visual” referring to the evoked responses, “if possible”.
Q The request source is written as “Harvey”, Dr Harvey, and the reason for the request, “Disintegrative disorder + inflammatory bowel disease”. Can you speak to the document and explain to the Panel what was going on in relation to these events?
A Certainly. In accordance with my agreement to arrange these tests once they had been ordered by the clinicians – and you can see earlier in the document that order being given by Professor Walker-Smith – I undertook to arrange it and in this case did arrange it with the department of electrophysiology.
Q Again, with the head of charge – for the Panel’s note, 27(e) and 27(f) – in the back of one’s mind, did you in any sense order these tests?
A No, I did not.
Q What did you intend to convey by the reference to disintegrative disorder and inflammatory bowel disease?
A This was part of the differential diagnosis, or working diagnosis, according to the information provided to us originally by Dr Mark Berelowitz and based upon the symptoms. It was a label that I had agreed in advance with the head of department I would give to these forms when I filled them in so that he would recognise that it was one of these particular children.
Q In the course of your narrative answer a few minutes ago, you referred to the ordering being carried out by Professor Walker-Smith in earlier documents.
Q Can we just turn back now, please, to page 7? Is there an entry there that you would wish to point to to illustrate the point you are making?
A There is. If we go to the bottom of the page, it says “WR”, that is ward round, “Prof”, so that is a ward round with Professor Walker-Smith, and you see four lines down “MRI, EEC”.
Q I think you have already said you did not take any part in that yourself.
A No, I did not.
Q Could I now move on to one other point in the chronology in May? If you move to page 80 of the Royal Free notes, this is a report sent to Dr Bennett, who is a consultant community paediatrician, in respect of both Child 6 and Child 7. Just very briefly, you can see that it is copied to you, amongst others, at the bottom of page 81. It is primarily a reference to Child 6, but I will deal with it in this context. In the second paragraph, he says:
“Child 6 was admitted to our Unit in October of last year. He is one of a group of children we have been investigating of a possible association between part of the autistic spectrum and gastro-intestinal symptoms. There is also a possible association of these problem with measles immunisation.”
That was how Dr Casson understood it. Do you want to make any comment – and I appreciate this is in relation to Child 6 – about the concept which is being spoken about there by Dr Casson?
A No. I think it captures it rather well. “a possible association between part of the autistic spectrum and gastro-intestinal symptoms.” That is precisely the clinical aspects that were undergoing investigation. “a possible association of these problems with measles immunisation.” Again, that is something that was being investigated, particularly under my direction, and you will note also the reference to “measles immunisation”. Clearly this child and the other children received the measles, mumps, rubella vaccine, but it was the measles aspect of their vaccine with which we were particularly concerned and this umbrella term of measles immunisation is something that we see recurring throughout this body of literature.
Q Can you put those bundles to one side, please, and take volume 2 of the Panel bundles and go to page 605d? I am now back to the point at which I invited you to make a mental note of the Royal Free hospital notes, page 85. I am dealing with it now because of the chronology. This is a letter which we have looked at it earlier this morning in the context of Child 6. Can I set the scene now, please, by looking at this letter from the standpoint of Child 7. You are writing to Mrs 6 and 7. I do not think I need read it out again. You record the diagnosis in respect of Child 7: developmental disorder on the autistic spectrum between Asperger’s and autism. You explained this morning how it came about that you were having a conversation and then writing to Mrs 6 and 7.
Q If we then go to pages 605G and H, this is also dated 3 June 1997 and is addressed to you. It is in respect of Child 7, signed by Dr Berelowitz. He says in the first sentence:
“Thank you for referring [Child 7] to me.”
If we just pause there and turn back to page 605E, the same phraseology is used in the first sentence. Is that right?
Q Did he set out to you, Dr Wakefield, Dr Berelowitz’s examination – I use that in a broad sense – and assessment, ending up in the last paragraph with his final assessment:
“I do think that [Child 7] suffers from a developmental disorder, perhaps somewhere between Asperger’s and Autism.”
Did that form the basis of the letter that you then wrote to the mother?
A It did.
Q This letter also on the face of it – and I stress that – attributes the referral to you.
Q Can we now look, please, back, with those matters in mind, to the Royal Free bundle, page 85?
Q On 17 January 1997 Professor Walker-Smith writes directly to Dr Berelowitz, and this is in relation to Child 7:
This child will be admitted on 26 January 1997. He is a sibling of [Child 6] who is already in our protocol”,
and so on.
“… the GP has not referred the child for full investigation”,
and so on, and we looked at this earlier. All right?
Q How do you read that letter?
A I think this may help clarify things in the minds of the Panel. This is a typical clinical referral letter and it comes from Professor Walker-Smith, appropriately, and goes to Dr Mark Berelowitz. You will see nothing of this sort written by me in any of the records, so this is a typical clinical referral, Professor Walker-Smith asking Dr Berelowitz to see and assess this child.
Q Would you turn to page 84? On 17 April 1977:
“[Child 7] is the sibling of [Child 6], a child in our Autistic Study.”
Then I think I can leap from that part to the middle part, where he says:
“However I don’t believe that you have yet seen [Child 7]. There is some confusion as to what his diagnosis is. His mother tells me that his behaviour is rather deteriorating … I would be most grateful if you could send an outpatient appointment to review him and to give us the benefit of your opinion concerning a possible diagnosis.”
First of all, did you have any part to play in that decision making?
Q Is there a point that you want to make about the references generally from the reference in the correspondence from Dr Berelowitz which appears to suggest that you had referred these children or some of the children to him?
A Yes. I think this sequence of letters exemplifies Dr Berelowitz’s error or misunderstanding of my role and what he is receiving here are typical clinical referrals and acting on them in due course, and I had no part in any of this.
Q You did touch on this earlier and perhaps I could just tease it out starkly. Did you at any stage send a written letter of referral to Dr Berelowitz in respect of these children?
Q As with some of the other children, Dr Wakefield, there is some correspondence which post-dates The Lancet publication and it is before the Panel and you should have an opportunity of dealing with it. First of all, if you look at the Royal Free notes again and look at page 64, we are now in August of 1998 and Professor Walker-Smith is writing to you on the 11th about Child 7 following a clinic on the 5th. In this letter – and I am just going to summarise, I hope fairly, the first several lines – he is dealing with matters which had obviously appeared to him during the course of the clinic. I pick it up just about six lines from the bottom;
“However the reason for writing to you particularly at the moment is that [the] fact that we repeated his urinary amino acids which were still strongly abnormal with the picture suggesting dihydropyrimidine dehydrogenase deficiency as it did before. Perhaps you might care to discuss this with the biochemists as to whether this is relevant and whether we need to pursue it further. I also noted that [Child 7] had not had his skin prick tests done and so we need to arrange these on his next visit. I will be asking him to come to the Friday clinic on the next occasion.”
Did you receive that letter in any sense wearing a clinical hat?
A No. I confess I have not heard of this disorder or possible disorder before but I imagine that it was something that Professor Walker-Smith brought to my attention because of its potential significance in the context of what I was doing in this research and whether there was further work that I could do or anything that might contribute to understanding this particular aspect.
Q What about the concept of a discussion with biochemists? Is that within or outside the parameters of your employment?
A No, that is certainly within it, and an information-gathering exercise that has no direct role in either the in-patient or out-patient clinical management of a child.
Q Would you look at the GP records now, please, and look at page 215? This is a document which I think was identified during the last session, dated 21 December 1998 and headed “To whom it may concern”, dictated by you and signed in your absence:
“This is to confirm that [Child 7] is one of the number of children investigated at the Royal Free suffering from a newly identified syndrome comprising of chronic bowel inflammation and autism. The long term natural history of this condition is yet unknown, but it is likely that the bowel disorder as well as the autism will require long term medical supervision.
It is notable that the novelty of the syndrome and the lack of understanding of the origins of developmental disorders in children has often led to conflict between parents, the medical profession and the various authorities.”
A number of points, please, for your consideration. How did it come about that you drafted that document?
A Mrs 7 contacted me and requested a letter in relation to Child 7. I believe the circumstances of this were that she was in an argument for some reason – I do not remember the details – with the social services, the local social services, and I said to her that I was not able to write a clinical letter about her child specifically but what I was able to do was to write a generic summary of what it was we were identifying in our programme at the Royal Free and I hoped that that would suffice in resolving the dispute. That is the reason for adding in the second paragraph this reference to the conflict that this issue has often led to between parents and various authorities.
Q Was this in any sense evidence of you dipping your toe into clinical management, if I can put it that way?
A Not at all. It was in every respect a generic letter and it had no impact whatsoever on the in-patient or out-patient management of this child.
Q I move on again later in time. Perhaps you could turn to page 155. We are now in January1999, a letter dated 29 of that month from Professor Walker-Smith to Dr N, copied to you. It is a reference back to the clinic on 27 January as you can see at the top of the page.
“Dear Dr N
We saw [child 7] again in the outpatient clinic …”
and he sets out the reasons. In the second paragraph he records what was found on examination and gives advice about medication. On the last line he says:
“Dr Wakefield will be in touch in due course with the family about these investigations.”
It is copied to you. How did you read that reference that we see in that last paragraph?
A First and foremost – and this is not my letter and I am sure that Professor Walker-Smith will provide his interpretation – as the Panel have seen, I had no clinical role in the management of this child at all and therefore the clinical investigations referred to in paragraph 2 will have been communicated to the doctor by the clinical team. With reference back to Professor Walker-Smith’s letters to the GP about Child 6’s brother, I might take the last paragraph, the last sentence, to refer to his investigations, in other words, my research investigations, because you may remember that in his letters about Child 6 he referred to me making contact with either the GP or the parents about the results of my investigations. I do not wish to over-interpret or misinterpret someone else’s letter but that would have been my understanding of this at that time.
Q The Panel will be reminded in due course about Dr N’s evidence in relation to that last sentence. The last document, please, is at page 46. (After a pause) I think that may be an erroneous reference. Could I leave that for the time being? It is not particular germane to what I need to adduce at this moment and I may come back to it. I will put that on hold. Therefore, Dr Wakefield, can we just stand back and look at the overall situation with Child 7 and here it may be useful, just so that the Panel have it at the back of their minds, to look at the structure of the charges. The relevant live, if I can put it that way, allegations relating to this child run from head of charge 27. I am going to adopt the same approach as I have done with every single one of these children and will continue to do so. So far as the investigations were concerned in relation to this child, what elements as far as you were concerned were research investigations?
A This was the analysis of biopsies taken during his routine colonoscopy.
Q Just so we are clear about it, were those biopsies in fact analysed?
A Yes, they were.
Q Would you have required EC approval for those biopsies and subsequent analyses?
Q Did you have EC approval for that?
Q Would you have expected EC approval in respect of the other investigations?
Q Again, in relation to this child, and I just ask it in the round, was it relevant that the start date applied to any aspect of the investigations and management of this child?
Q That deals with head 27(a). I want to look at head 27(b)(i) and 17(b)(ii), the concept of entry criteria. As far as you were concerned, were entry criteria relevant?
Q Consent forms, head of charge 27(c). Would you have expected consent forms to be available and put into the clinical notes in relation to the investigations which you have described as being clinical in nature?
Q Take the Royal Free bundle and look at page 107. What is the status of that document?
A This is a Royal Free Hampstead NHS Trust consent form for routine clinical investigation, in this case colonoscopy and biopsy.
Q Would you expect a consent form for the research biopsies and the consequent analyses?
Q Would you turn to page 106 and tell us about the nature of that document?
A This is a consent form for research biopsies pursuant of 162/95.
Q From your standpoint, would you expect there to be any other consent forms in respect of any other aspect of these investigations?
A Not for the research. I imagine that there were consent forms for other clinical investigations such as MRI, but I think they may be missing from these records.
Q Apart from those, would you expect there to be, if I can put it this way, an overarching research consent form?
Q And does that apply to the other children?
Q Legal Aid. There is a reference in the GP notes which I am not suggesting you saw, but it may be helpful just to turn it up. Page 266. It begins at 265, in fact. It is important to get the date here at the top right-hand corner, which is 1 June 1997. It is a letter from Dr N to Dr Baird – Gillian Baird – at Guys’ Hospital. The content of the first page I am not concerned with for present purposes. I take you to the second page. He says this as of June 1997:
“I would add that Mum is very active medico-legally and has been involved with the groups suing The Department of Health for the MMR and its possible association with autism.”
Just two points: quite apart from the concept of suing the Department of Health, to you knowledge did that ever happen?
A I am sorry? Suing the ---?
Q Department of Health.
A No. That did not happen.
Q Leaving that point aside, as matters stood so far as you were concerned, at the time of referral, did you know of any involvement by the mother in medico-legal matters?
A No. There was no mention of litigation at that time.
Q Did you become aware of any medico-legal interest or activity by the mother on some subsequent occasion?
A Yes, at some point during 1997, but I do not remember when.
Q Being active medico-legally may be one thing, but what about the existence or otherwise of the Legal Aid certificate. Did you know one way or the other?
A At the time, no, but I now am aware that she did not have a Legal Aid certificate at the point of referral and investigation.
Q Thank you very much indeed. That is all I seek to ask you about Child 7. Could we move on to Child 8 please. I think you will need the GP notes and the Royal Free notes. Do you have both those volumes there, doctor?
A I do.
Q Could I begin therefore by asking you to turn open the GP records at page 119. Look at the letter first and step back, and look at the background. Dr Jelley is the GP for Child 8 and she wrote to you on 3 October 1996, addressed to “Dr Wakefield” at the Royal Free Hospital.
“[Child 8’s] mother … has been into see me and said that you need a referral letter from me in order to accept [Child 8] into your investigation programme. I gather this is a specific area of expertise relating to the possible effects of vaccine damage and her ongoing GI Tract symptoms. As far as I am concerned if [the mother] is happy to proceed with this and it gives her any further information and peace of mind I am sure it would be beneficial for both her and [Child 8]. I enclose photocopies of some recent correspondence…”
And in so far as we need to look at it, that is in fact pages 23-28 of the Royal Free notes.
“… which gives a fair idea of [Child 8’s] current state. I would simply reiterate Dr Houlsby’s recent comment that both the hospital and members of the Primary Care Team involved with [Child 8] had significant concerns about her development some months before she had her MMR Vaccination. I take Mum’s point that she has video evidence of [Child 8] saying a few words prior to this vaccination being given and her vocal abilities are now nil but I don’t think we can be entirely convinced as yet the vaccine is the central cause of her current difficulties. However I am quite prepared to support [Mrs 8] in her quest for further information and I hope some useful results come from these tests.”
I have read that out in full. It was read out in full perhaps more than once in the last session, but the last session was a long time ago. Do you remember receiving this letter?
A Vaguely, yes.
Q Let us just stand back and look at the background leading up to this. Did you have any contact with Mrs 8?
A Yes. She called me.
Q What did she say?
A She described the events in the evolution of her daughter’s problem. I think her daughter was the second of two children and had had some early problems with respect to the fact that her development was slower than that of her sister. It had been assessed and deemed normal apparently. She was then found to have coarctation of the aorta. Some time following that she had repair of the coarctation, and had progressed well and was rapidly acquiring speech. There were no other concerns, as I understood it. Shortly after her MMR vaccination she had a number of symptoms, and this has been a recurring theme throughout this, that it is not merely development problems but there was a rash and a fever. There may have been convulsions, and the onset of gastrointestinal problems. She was seeking help with respect to her child’s symptoms and asking me – I think she may well have heard through the grapevine, through the internet or otherwise, mechanisms, through other parents – about work that was being undertaken at the Royal Free and asked if she could get help for her daughter.
Q What did you judge her motivation to be?
A She was entirely concerned with the well-being of her daughter, as far as I was concerned.
Q Was there any question of litigation involvement at that stage?
A I do not remember any being discussed. That is not to say that it was not; I simply do not remember it.
Q Did you give her any advice?
A Yes, I did. As with all the other parents, I said that if she wanted to get help for her daughter, particularly with respect to the gastrointestinal problems, then she should ask her GP if they felt it appropriate for referral to Professor Walker-Smith.
Q Was that the only conversation you had with Mrs 8 at that time as far as you recall?
A As far as I recall, yes.
Q Did you have any discussion with Dr Jelley at that time, before the referral letter on page 119?
A I do not think so.
Q Going back now to the letter, the GP, Dr Jelley, sets out on the first line that I have read already, she had been in to see her and “… said that you need a referral letter from me…”. If we can be more specific, how did you put it to Mrs 8?
A Again, there is a common thread of error that runs through many of these letters being sent to me instead of to Professor Walker-Smith, letters going to the wrong department, in this case being addressed to the Royal Free Hospital. Again that is not a criticism of the parents. It is a fact that what they may have heard over the phone is not then passed on to their doctor in quite the same form. Nonetheless, I will have told the mother that if she wants a referral to Professor Walker-Smith then she will require that her doctor make that referral by way of a letter to Professor Walker-Smith.
Q And in relation to the reference to, and I quote from the paragraph, “… you investigation programme”, what were you saying about that? Was it “your investigation programme”?
A No. It was “our investigation programme” and it was composed of the clinical elements under the direction of Professor Walker-Smith and the adjunct research elements under my direction.
Q Would you turn to the Royal Free notes, please, at page 35. Just to cross-reference, the letter we have just been looking at is at page 36 of the Royal Free notes. Let us look at page 35. On 9 October you write to Professor Walker-Smith in these terms:
“Please find enclosed some details of the girl who was referred to me with secondary autism and bowel problems. I requested that a letter of referral be sent to you and I hope that this has been done. Nonetheless, here is confirmation of the referral and some further details.”
Let us just look at that letter, please. When you used the expression “secondary autism and bowel problems” what was the basis for you using that description?
A Secondary autism is a term which I think first appeared in a letter from Dr Rosenbloom in the context about a child. I thought he meant by it and what I meant by it in this context, I imagine, was a child who was normal, or near normal, and then developed a regressive pattern of autism. I cannot think of any other connotation attached to it.
Q Did the information from the mother and the documents from the GP play any part in that description?
A That is a very good question. I cannot remember.
Q The next sentence reads:
“I requested that a letter of referral be sent to you…”
A That is a correct statement and is what I had asked of the mother, but the referral had come to me in error.
Q Again, when you were passing on this information to Professor Walker-Smith and indeed when you were discussing matters with the mother, were you at any stage suggesting referral here for the purposes of research?
A No. The mother’s emphasis was upon clinical care and the overall, the overriding, emphasis of this programme was obtaining clinical care for children. Research was very much a secondary aspect of that.
Q There does not appear to have been an outpatient appointment. Did you have any role to play on the assumption that there was not an outpatient appointment?
Q Professor Walker-Smith then is involved. If we look at page 22 on 3 December, it says:
“Dear [Mrs 8]
I have had documentation concerning [Child 8] and I have heard that you would like us to go ahead with the investigations. I have arranged for [Child 8] to be admitted on Sunday 109 January 1006. The colonoscopy will be the next day and other investigations will be arranged during the week. [Child 8] would be able to go home on the Friday or Saturday.”
It is copied to you and others. Did you have any role in the decision to admit this child?
Q Did you know anything about any communication that there may have been between Mrs 8 and Professor Walker-Smith?
A No – other than this letter, of course.
Q Other than this letter. That is what I was asking. And did you have any part to play in the apparent decision that this child should undergo a colonoscopy?
Q This child was admitted. Just a note where it is: page 7 of the Royal Free notes. In the top left-hand corner, the Panel may also have already noted this, that there appears to be the usual date error at the beginning of the year. That should be 1997 at the top. Again, the same question. Do you actually positively recognise this writing or not?
Q Did you have any role in the clerking in of this child?
Q If we move on to page 9, as part of this admission, we see on that page at the top, “WR Prof”, a ward round, and:
“Behaviour deteriorating since evening primrose stopped”
“Awaiting - MRI, EEG, Dr Berelowitz [tick] histology
BA M + FT looked normal
Plan: Histology report pre D/C”
And then somebody’s coded signature. The rest of that page is self-evident. I just note the rest of the entries on 24 January:
? EEG post MRI”
Then at the bottom of the page, on 21 January 1997, “Histology normal”. So far as these investigations are concerned, first of all, the decision making for them. Did you have any role to play in any of those?
Q In respect of them, at the time – and for these purposes I am using that phrase right up until the time of The Lancet publication – did you have a view about the nature of these investigations?
A My view was that they were clinically indicated.
Q What about the order or the sequence in which these investigations were done? Did you play any part in that?
Q One of the investigations I would like you to look at, please, on pages 87 and 88 concerns the EEG. I say EEG; it says EEG on the form, but in fact more particularly it relates to EP. If you look at pages 88, does that appear to be a report of an EP test?
A It does.
Q Looking back at page 87, the EP box is ticked. Is there any writing on that form which is yours?
Q I would like you to look, please, at pages 90 and 91. This is a photographic consent document that we have looked at in respect of a previous child. There are two areas I would like you to comment on. First of all, what was the purpose for which a consent was taken for a photograph?
A As I mentioned in the context of another child to the Panel, part of my responsibilities, in addition to research, was teaching. Novel clinical signs or aspects of these children were of interest, could be captured by photography and were a very useful teaching tool. Clearly obtaining a photograph and consent to use that photograph requires a consent form such as this signed by the parent.
Q Again, was this in any way you dabbling in clinical matters?
A Not at all.
Q The second aspect concerns the second box down, which is noted “Diagnosis” and you see what you have written there:
“Regressive autism + ? inflammatory bowel disease”.
Again, what did you intend to convey by using that expression on this document?
A Based upon my understanding at the time, that was the likely diagnosis in this child.
Q On page 91, just to complete the picture, have you set out the nature of the photograph which was considered suitable?
Q Again, I am not sure I asked you this formally, but is all the writing on this document yours?
A Yes, it is.
Q At page 93, we have a document which we were told was in Dr Casson’s writing. Halfway down, under the box, it says in his writing, “Dr Wakefield protocol”. As a matter of fact, did you yourself have a protocol?
A Yes. I had a research protocol for the analysis of biopsies which was part of the larger clinical and scientific protocol.
Q Can we just look briefly at three entries relating to Dr Berelowitz? This starts at page 20 of the Royal Free notes. This is dated 21 January 1997 and is addressed to Dr Berelowitz:
“Will you please see the above patient, give your opinion regarding treatment/prognosis/diagnosis and undertake the further care of this patient.”
It is signed by a house physician. We see that circled. Did you have a house physician as part of your team?
A I did not.
Q The house physician writes in the second line:
“[Child 8] is in Malcolm Ward for this week for investigation of ? Disintegrative disorder/Enteritis syndrome ….”
Further detail of the history is set out and it ends up by saying, “Many thanks for your opinion”. Did you have any part to play in that request?
A No, I did not.
Q If you turn back to page 9, which we looked at a little earlier, we see the date of 23 January at the top, which is two days after the house physician’s note and we see a reference there to “awaiting”, amongst other things, “Dr Berelowitz”. Again, for the avoidance of any doubt, were you involved in asking Dr Berelowitz on a clinical basis to get involved with this child?
Q Then we can go to page 18. This is a letter of 28 January 1997 from Dr Berelowitz, copied to you, and we see it is written to Professor Walker-Smith:
Thank you for referring [Child 8] to me …”
The rest of the document I am not concerned with for current purposes. Is that in accordance with your understanding of the arrangements at that time, or not?
A Yes, it is.
Q There is a discharge summary we could look at briefly at pages 76 and 77 in the GP notes written by Dr Casson. As a matter of fact, this arose somewhat late in the day. This is dated November 1997 in relation to the admission in January. That is not my concern. I would like you to look, please, at the first two or three lines:
“[Child 8] was admitted to our ward at the Royal Free Hospital on the 20th January 1997 for further investigation of possible association between developmental delay, gastrointestinal symptoms and vaccination.”
Again, does that sit easy with your understanding of the position?
A I think the expression in this context relates specifically to this child and particularly the reference to developmental delay, gastrointestinal symptoms and vaccination. Otherwise, that is entirely in accord with my understanding.
Q Can you turn, please, to the second page of that letter? Having summarised the results of the colonoscopy at the top of the page, including barium meal and the MRI scan, there are a whole series of blood results. At the bottom of the page, he says:
“These results therefore are not indicative of marked ongoing inflammation. The results from Dr Wakefield’s specific investigations concerning the measles antibody would be available from him.”
Dr Wakefield, can we look at that for a minute? Has Dr Casson got that right?
A Yes, he has. I think by this stage Dr Casson has a clear grasp of the division of labour here and has written a very full clinical discharge summary and has referred at the end to specific investigations from my laboratory concerning the measles antibody. It is the antibody technique which is the immuno-histo chemistry. Those results, correctly, would be available from me.
Q There are about four documents which relate to the post-admission period in 1998 which I would like your help with. The first one is at page 14 of the Royal Free notes. This is a letter dated 15 January 1998 from you to Professor Walker-Smith:
“[Child 8’s] mother has phoned me to say that her gastrointestinal symptoms are particularly severe at present. I note that she has changes typical of the syndrome in her gut, although they are mild. She has not received any 5-ASA and I think she would be an ideal candidate for mesalazine. If you decide to put her on this, Jill and I will keep in touch with [Mrs 8] and Dr Jelley, the general practitioner, to monitor progress in view of the long distances involved.”
Can we just break that down into its constituent parts? First of all, were you in contact with Mrs 8 at this stage?
A Yes, I was. I had not been in contact with her until this point following our original telephone conversation and her attendance at the Royal Free, but she had gone back home and clearly at this stage her child had marked gastrointestinal symptoms and she was calling me to inform me of that.
Q Did you understand that she had not received any 5-ASA?
A Yes, I did. As I mentioned earlier, we were in the early stages of planning a trial of anti inflammatory medication and our nurse, Miss Thomas, and I were scrutinising the notes to look for evidence of clinical improvement in children. By that stage, I remember that the histological profile of this child was of a mild inflammatory change, but she had not been put on any anti inflammatory medication. I think that diagnosis was something which was resolved perhaps later and that may be the reason for that. I felt that it was my duty to pass that information on to Professor Walker-Smith, so that he might then make a decision as to whether he wanted to treat this child with anti inflammatory medication or not.
Q In that letter, you express an opinion, do you not?
A Yes, I do.
Q You say:
“… I think she would be an ideal candidate for mesalazine.”
If it were suggested to you that you have no right to make a suggestion about treatment, what would you say to that?
A Again, I think Professor Booth has been helpful in this respect. It is entirely consistent with my role to make suggestions. It is not consistent with my role to make executive decisions and prescribe and that is what I am doing in this context.
“If you decide to put her on this, Jill and I will keep in touch with [Mrs 8] and Dr Jelley, the General practitioner, to monitor progress.”
What role might there be on your part in monitoring progress? For what purpose?
A Again, in anticipation of a possible clinical trial we were following up to see whether parents had documented or recorded any benefit in their children, whether they had noticed clinical improvement as a basis, a rationale, if you like, for justification for such a trial. So Ms Thomas and I, and she in particular, took it upon ourselves to design a questionnaire that might help capture that information and assist in the justification for an experimental clinical trial.
Q Were you stepping outside the boundaries of your employment?
A Not at all. I had an experimental role; I had a role as a researcher and we were now looking at a research aspect, that is, the merits of an experimental trial of five aminosalicylates in this disorder.
Q We have to look, I think, in the GP bundle at page 74. On the same day you wrote to the GP.
A I have it, yes.
Q The first letter of this date was to Professor Walker-Smith, the second letter is to Dr Jelley.
“I have recently been contacted by [Mrs 8] and realise we have not spoken for some time. We are now coming up to the 38th child investigated for this syndrome and the findings have been remarkably consistent. Please find enclosed the first paper covering the initial 12 children, including [Child 8]. This is due for publication in The Lancet in the next few weeks.”
Again, so we keep our bearings, was that the draft of what in fact became The Lancet paper?
“We have had some success (striking, in some cases) in treating these children with mesalazine. Both gastrointestinal and behavioural improvement have been noted. I have written to Professor John Walker-Smith suggesting that we start [Child 8] on mesalazine, and he will be writing to you in the near future.”
Two points here. When you say in the second paragraph, using the word “we”,
“We have had some success (striking in some cases) in treating these children …”,
did you intend to convey that you personally had been involved in treating these children?
A Not at all, not in terms of treatment. The aspect that I was latterly involved in is trying to help assess the efficacy of that treatment by inquiring from the parents as to what they felt the benefit, if any, had been.
Q Then in the GP bundle at page 73, the previous page, there is a letter from Professor Walker-Smith to Dr Jelley of 14 April 1998, copied to you:
“I understand that [Child 8] continues to have gastrointestinal symptoms. I do believe that it would be appropriate to give her a therapeutic trial of … Pentasa in a dose of 500 mg daily.”
Again, Dr Wakefield, in the light of the correspondence you have been taken to, is there any comment you want to make about that?
A No. This is entirely consistent with Professor Walker-Smith’s executive decision-making role and he copies the letter to me, I imagine so that then Ms Thomas and I can do as I suggested, and that is follow this child by seeking the parental input into whether the child shows improvement or not.
Q In relation to the decision to prescribe Pentasa, were you involved in that executive decision making?
A No, I was not.
Q That is all I ask you about the body of the notes and we come to the backdrop of the charge and the live charge is head 25, and I am looking at head 25(a) and (b), certainly the stem of (b). In relation to this child, Dr Wakefield, as far as you are concerned what aspects of what was done constituted research?
A The laboratory based analysis of biopsies taken during the course of routine colonoscopy.
Q As to the other investigations, and we have looked at them in summary form, how would you characterise those?
A They were clinical.
Q From your standpoint, is it appropriate to take them all together and characterise them as research?
Q In respect of the investigations or the investigation and analysis which you have characterised as research, would you have required EC approval for those?
Q Did you have it?
Q What was it?
Q Was a start date relevant for these activities?
Q So far as entry criteria are concerned – and I have in mind head of charge 25(b)(i) and 25(b)(ii) – were they relevant?
Q Consent forms, head of charge 25(c). In respect of the investigations which you characterise and understand to be clinical in nature, would you expect there to be a consent form for those?
Q If you take the Royal Free notes and look at page 96, what is the status of that document?
A This is a Royal Free Hampstead NHS Trust consent form for routine investigation, in this case colonoscopy under sedation.
Q In respect of the biopsies and consequence laboratory analyses, would you expect a research consent form for that activity?
Q If you look at page 97, how do you characterise that document?
A This is a consent form for research biopsies pursuant to 162/95.
Q The Lancet, again the same question. Insofar as you and your role in the drafting exercise for The Lancet paper, what materials were available to you?
A I had the entire contemporaneous clinical record and I believe some developmental records from the red book held by the mother and the detailed histological proforma available from Dr Dhillon’s analysis.
Q The last matter touches the question of legal aid. If you go to the GP records, please, and turn to page 96, on 17 June 1997 Dawbarns wrote to her and asserted in the first paragraph that not only they were acting for the parents of Child 8, but that:
“Legal aid has been granted to enable us to investigate a claim for compensation following an injury which appears to have been caused by a vaccination.”
That is of 17 June 1997. Again, there is just one other document, which I am not suggesting you saw, I do not think it is being suggested you saw, but if you look at page 28, on 30 September 1996 – this is going right back now, turning the clock right back to the referral stage – there is a telephone call:
“Mum taking her to Dr Wakefield Royal Free Hospital for CT scans/gut biopsies ?Crohn’s – will need ref letter – Dr W to phone me. Funded through legal aid.”
That is a note of a phone call with the mum. So far as you were concerned, Dr Wakefield, did you become aware, and if so, when, that this child was in receipt of legal aid?
A From the letter that you showed just now it would seem to have been some time during the course of 1997. It seemed to be the case that these letters went out soon after an award had been made. So going back now to 1996 I am not entirely sure what this refers to. The mother may have been in touch with JABS or other organisations and there certainly was the emerging concept of a Legal Aid Board pilot study that JABS may have known about, but other than that I cannot really help on that one.
Q Can you help on this? Did this child become one of the Legal Aid Board five?
A It is quite possible. I am afraid I cannot remember.
MR COONAN: Thank you very much indeed. Sir, that is all I ask in relation to Child 8.
THE CHAIRMAN: Thank you very much indeed, Mr Coonan. It is now 1 o’clock and we will adjourn and resume at 2 o’clock. Dr Wakefield, you are still under oath.
THE CHAIRMAN: Good afternoon to you all. First of all, just a couple of things.
I have been informed that Professor Walker-Smith is going to leave at about quarter past three to half past three and I have been informed that he has no objection to the proceedings continuing in his absence.
MR MILLER: That is right, sir. Thank you.
THE CHAIRMAN: That is accepted and is a matter of fact. The second point, I think Mr Coonan, at some stage you are going to come back to head of charge 16. You may not be in a position to do so now, but we can take that later on at your convenience.
MR COONAN: Yes, we are going to have a word about it, but I am not in a position to deal with it now.
THE CHAIRMAN: That is fair enough. I am just giving a reminder.
MR COONAN: Yes, of course.
THE CHAIRMAN: Mr Coonan?
MR COONAN: Sir, I am going to ask Dr Wakefield to deal with Child 9 and we will need the Royal Free records and the local hospital records, volume 2. (To the witness) Which ones have you been provided with?
A I have the Royal Free Hospital.
Q Can we just pause for a moment? (After a short pause) Can we start, please, by looking in the local hospital records volume 2 at page 182. I am going to read this out to remind ourselves of the circumstances of the referral. It is a letter written by Professor Walker-Smith to Dr Clifford Spratt:
We recently have become aware of a syndrome of enteritis and disintegrative disorder or autism. We have in fact investigated two children so far and during treatment they both had evidence of bowel inflammation. Whether this relates to Crohn’s disease or whether it is related to measles immunisation or measles itself is quite unclear. However, I have heard from Dr Wakefield that there is a child called [Child 9] who is resident in XXX whose parents would be quiet keen for us to investigate the child in our protocol. I am just wondering whether you think that this is at all appropriate. If you felt it appropriate I would be happy to see the child.
Just in case you may be interested, I am enclosing a copy of Dr Wakefield’s detailed proposal. I look forward to hearing your comments.”
Instead of just going forward for a minute let us step back. Did you know something of this child and the circumstances prior to this letter?
A Yes, I did.
Q How did that come about?
A The mother of Child 9 is a friend and close contact of the mother of Child 2. Through the mother of Child 2, she had become aware of the work that was being conducted at the Royal Free. Accordingly, and particularly in light of the diagnosis of bowel disease in Child 2, which she had become aware of and I think by that stage of some clinical benefit to Child 2, then the mother of Child 9 made contact with me to seek help in getting care for her child.
Q What did she tell you about the circumstances in relation to her child?
A She told me of a child who had undergone normal early development, and who had at some stage during his second year of life undergone development regression and the onset of bowel problems. Again, like the mother of Child 2, she was extremely well informed, a very intelligent woman and she had made an association between her son’s intestinal symptoms and the neurological problems. He had, in fact, been investigated for this at the Chelsea and Westminster Hospital. This is one of the reasons that this finds inclusion in what was to become our protocol later. Her child had undergone a Schilling test for the investigation of possible abnormality of vitamin B12 absorption and that had in fact been abnormal. So here was a child that I felt fitted well into the sort of cohort of children that might benefit from Professor Walker-Smith’s attention.
Q So what advice, if any, did you give her at that stage?
A My advice to her was the same as my advice to other parents. That was, if she wanted to be seen by Professor Walker-Smith, then she should seek a referral from her general practitioner.
Q In terms of her motivation, as far as you could assess it or perceive it, how would you describe that to the Panel?
A As with the other parents, it was on the basis of seeking help for her child.
Q Having received this information from the mother, and having given her advice in the way you have described, did you speak about this child to Professor Walker-Smith?
A Yes, I did.
Q Why did you do that?
A By then we were working in the same hospital and were in regular contact, and the child was of particular interest because of a demonstrable abnormality of vitamin B12 absorption which had been demonstrated in investigations, I think almost a year before at the Chelsea and Westminster Hospital.
Q Did you ask Professor Walker-Smith to write a letter to Dr Clifford Spratt?
A No, I did not. In fact, Dr Spratt’s name had come up during the course of my conversation with Mrs 9. I had never heard of Dr Spratt before, but when I mentioned his name to Professor Walker-Smith, Professor Walker-Smith informed me that he and Dr Spratt had known each other for many years.
Q If you go back to the bottom of the letter on page 182, the reference in that letter to your “detailed proposal” is a reference to the following pages thereafter, is it?
A That I would imagine to be the case, yes.
Q Again, it may or may not matter but did you give Professor Walker-Smith a copy of that document specifically in relation to this conversation you were having with him?
A No, I do not think so. By this stage all of those within the collaborative group had this document.
Q And when Professor Walker-Smith writes, as he does towards the end of the first paragraph, to the effect that Child 9’s parents – and I am quoting directly from the letter “… would be quite keen for us to investigate the child in our protocol” – how would you read that reference?
A That is entirely correct, as I had articulated it to the mother. We were investigating these children, principally on the basis of clinical need. They were undergoing a series of clinical investigations and, in addition, there was an adjunct analysis of biopsies for research purposes by me. That sentence captures that accurately.
Q Would you like to turn back a page to page 181. We have a letter from Dr Spratt in response to the letter we have just been looking at dated 25 September.
Thank you for your kind letter of 11th September, and enclosures.
I would of course be very pleased to have your opinion of [Child 9’s] distressing case history, and to take your advice about his proposed referral to Dr Wakefield’s service.”
That is his phraseology, obviously. Any comments you want to make about that? Were you running a service?
A No, I was not. It is slightly confusing to me. A detailed clinical and scientific protocol had been enclosed to Dr Spratt by Professor Walker-Smith, but in that it emphasises the various role for the investigators, particularly the clinical role of Professor Walker-Smith and his team. There is no mentioned of a service in that. In my understanding of the term “services”, a clinical service and I have no clinical service. So either Dr Spratt has misunderstood or he has not read this document in detail.
Q Again, so that we have the parameters of the document clear, is the document to be found at pages 183 through to 203?
Q And it has also running sub-pagination running from page 2 at the bottom of 184, right through to page 21 or page 23. It is a complete document?
Q If you please, just briefly turn up the Royal Free notes to page 17. Do you have those?
Q This would appear to be an outpatient appointment on 8 November 1996 and the stamp at the top is in fact a reference Dr Murch. Did you take any part in this outpatient appointment?
A Other than as an observer, no I did not.
Q Do you remember being there as an observer?
A It is likely that I was, but I do not remember it.
Q Any management role there at all?
A None at all.
Q On the same day – that was 8 November – there is actually a bundle of local hospital records. Would you pick it up now at page 180. This is a letter dated 8 November, as I say, relating to the clinic of the same day from Professor Walker-Smith to Dr Spratt, copied to you, at the bottom of the page. There are a number of aspects of this I would like your assistance with.
“I duly saw Child 9 in the outpatients.”
He sets out various aspects of his gastrointestinal symptomatology, and I pick it up on the fifth line:
“We have no seen several children with autism and gastrointestinal symptoms, all of whom on gastrointestinal investigation have proved to [have] some kind of bowel inflammation. It is quite difficult to relate this directly to autism, Dr Wakefield as you know, believes that immunisation may play some part, although I remain neutral on this issue for the moment.”
Again, just stopping there, was that an accurate representation of the position as of November 1996?
“However the parents are keen that we should endeavour to investigate [Child 9] and I have therefore arranged for him to come in to have a colonoscopy. He will be admitted on the 17th November we will then .. endeavour to follow this by barium meal and follow through and also to do a repeat lumbar puncture. We will let you know the results of these investigations.”
Did you have any role to play in any decision to admit this child for investigation?
Q And particularly did you have any part in any decision that he should have a colonoscopy?
Q Or a lumbar puncture?
Q Repeat or otherwise?
Q This child was admitted to hospital on 17 November. Could you just for reference purposes go to the Royal Free notes at page 7. Did you have any part in the admission process of this child?
Q A series of investigations took place, and the succeeding notes demonstrate that fact. Can I take it, please, almost compendiously, in respect to these investigations which included colonoscopy and lumbar puncture. In terms of leaving aside the original planning at an outpatient stage, did you take any part in any decision-making that this child should undergo these investigations at a time when he was in hospital?
Q Who did you understand made those decisions or was responsible for making them?
A Professor Walker-Smith.
Q So far as the order in which the investigations were carried out, the sequencing of them, who did you understand was responsible for making those decisions?
A This was a consensus achieved by the senior clinicians.
Q Did you have any role in that at all?
Q The lumbar puncture was carried out on a re-admission on 9 December 1996, and you can pick that up, please, at page 11, at the bottom of the page – ward round, Dr Murch on 21 November. The second line:
“MRI + LP to be done under GA at a later date;”
then the date in brackets.
“as [Child 9] likely to be distress with local.”
Did you have any role in decision-making surrounding events at that stage?
Q And therefore if I can again borrow the wording of the relevant head of charge, 19(e) and 19(f), did you cause that lumbar puncture to be carried out?
Q The re-admission period also, as we can see from the records, included an EEG. I would like you to look at the relevant forms, please, at page 85 of the Royal Free notes. Can you just take in your hand as well page 86. If you look at the test number in the write hand corner of page 85, does that appear to link with the test number on page 86?
A Yes, it does.
Q And on page 85 the EEG box has been ticked and there are two points here I want to ask you about. Is any of the writing on this document yours?
A No, it is not.
Q Somebody has written in along side the “Request Source Consultant/GP” your name, and underneath “Walker-Smith”. And then, in the “Speciality” box “MED/PAED”. Were you in fact a requesting source for this test?
Q Go back to the local hospital records, please, for the position after admission. On 31 December, Professor Walker-Smith writes to Dr Spratt:
[Child 9] was duly admitted…”
And he sets out some of the findings which are self-evident. He says in the third subparagraph:
“Our diagnosis is indeterminate colitis with lymphoid nodular hyperplasia.”
Then in the next line he says:
“A therapeutic trial of Mesalazine … may be worthwhile.
We have now studied seven children all of whom have had some evidence of enterocolitis …”
That should be “disintegrative”, I think, although it says “disintegration” –
“ … disorder following MMR. Two of these may have Crohn's disease ...
Clearly this is a difficult group of children and our work is only beginning but we will keep you informed. I wonder if you have seen any other similar cases in XXX.”
This is Professor Walker-Smith’s letter and we can ask him about that in due course, but when he says, as he does, halfway down the page:
“Our diagnosis is indeterminate colitis with lymphoid nodular hyperplasia.”
Can you just help the Panel, please? This is a generic question. To what extent were you involved in making a diagnosis of the type we see illustrated here?
A This is a clinical diagnosis and I had no role in making that.
Q When Professor Walker-Smith said that this was a difficult group of children and “our work is only beginning”, would that be a description which could apply to you?
A Yes, indeed.
Q Can you spell that out for us? What work so far as you were concerned was only beginning?
A From my perspective, the research into the characteristics of the inflammation in the bowel on a laboratory basis and the possible association with virus cause.
Q I ask you to turn now to page 163. We are now another nine months down the line: September 1997. It may be necessary also for you to look at the following page, 164. Professor Walker-Smith writes to Dr Spratt on 1 September 1997:
“Thank you for your letter of 22 July.”
Pausing there, that is the letter on page 164.
“I have discussed the situation with Andy Wakefield. If there has been no change in symptoms on Sulphasalazine therapy, I would stop the drug. Ideally perhaps one would consider repeating endoscopy but without any symptomatic improvement this does not seem to be relevant. Later on as our knowledge of this disorder develops we may indeed need to repeat endoscopic and biopsy studies.”
I am not concerned about the latter part. So far as the first part is concerned, can I ask you this? In what respects might you have been discussing the situation with Professor Walker-Smith in relation to this child at this remove of time?
A I think one of the interesting aspects of this child was the high lead level and I think one of our topics of conversation was the possible association between lead toxicity and autism. I was not aware that any such association had been made, albeit that lead is a neurotoxin. Beyond that, I cannot say.
Q Would you have had an interest in discussing treatment?
A To the extent that we were, as I have said before, planning a possible clinical trial of mesalazine, monitoring children or at least monitoring them by their parents’ reports for efficacy of anti inflammatory medication.
Q That is all I ask you about the body of the notes. Can we turn to the background of the live head of charge? It is head 19. In relation to the investigations which were carried out, what aspects of any of those investigations do you say should be characterised as research?
A The analysis, the laboratory based analysis, of intestinal biopsies taken during his routine colonoscopy.
Q What about the other investigations which we have touched on by way of summary? How would you describe those?
A Those are purely clinical.
Q In respect of those clinical investigations, what was your state of mind in relation to those at the material time?
A That they were entirely indicated.
Q In respect of the research investigations you have just described, would you expect there to be ethical committee approval for them?
A Yes, I would.
Q Did you have it?
Q What was that?
Q Would you expect there to be any – and this is my phrase – overarching ethical committee approval for the totality of these investigations?
Q Was the idea or concept of a start date relevant in respect of the investigations which were carried out in respect of this child?
Q That is head 19(c)(i). So far as entry criteria are concerned, were those relevant considerations?
Q Head 19(c)(ii) and 19(c)(iii). So far as consent forms are concerned – the background to this is head 19(d) – would you expect there to be consent forms for the investigations you have characterised as clinical?
Q If you would turn to the Royal Free notes, please, and look first of all at page 44, what is the status of that document?
A This is a Royal Free Hampstead NHS Trust consent form for routine investigation, in this case an MRI and lumbar puncture under general anaesthetic.
Q Is that the sort of document you would expect to see if the investigations were designated as clinical?
Q At page 47, the characterisation of that?
A This is a Royal Free Hampstead NHS Trust consent form for routine investigation, in this case a colonoscopy under sedation.
Q Is that what one might expect in relation to a clinical investigation?
Q In respect of the research biopsies and consequential laboratory analyses, would you expect there to be a consent form for that?
Q Turn to page 46, please. How would you characterise that document?
A This is a consent form for research biopsies pursuant to 162-95.
Q Would you expect any other type of consent form in the light of the conceptual analysis which you have placed before the Panel?
Q So far as The Lancet publication is concerned, when it came to your role in the drafting process, what materials did you have available to you?
A As with the other children, I had the full contemporaneous clinical record, I believe some early developmental records and the detailed histopathology pro forma generated and filled in by Dr Dhillon.
Q Finally, legal aid. When you had your involvement with Mrs 9, which you have described, can you help the Panel, did you have any knowledge about first of all the existence of a legal aid certificate?
Q Did Mrs 9 articulate any motivation on the litigation front?
Q Taking it a stage further down the line, did you become aware at any stage about the existence of a legal aid certificate in relation to Child 9? I am not suggesting positively in that question that there was one; I just want to know whether you were aware of anything one way or the other.
A I do not know.
Q That is all I ask you about Child 9. I am going to turn to Child 10 and, to begin with, we will need the Royal Free notes and the GP notes. Dr Wakefield, there are two volumes of the Royal Free notes, but these references, until I say otherwise, are in volume 1. I am going to read some of this out. I make no apology for doing so, because there is a danger sometimes of blurring one into the other and I want to make sure there is differential between the children. Dr Hopkins was the general practitioner and you can see from the top of page 35 that the relevant date is 14 October 1996. He writes:
“Dear Professor Walker-Smith,
Thank you for seeing this unfortunate 3½ year old boy who has been extensively investigated by our local paediatrician.”
He sets out the history, given apparently by his mother, and says he had had an MMR vaccine in February 1994. Then in the fourth paragraph, he tells the Professor in the fourth line:
“No actual diagnosis has been given for [Child 10’s] condition but the most recent report states ‘severe speech and language disorder with some autistic features’ – 2.9.96.
[Mr 10] – who holds a PhD – has heard of your work and is keen for [Child 10] to be assessed by yourself.
The situation is obviously much more complex than I am able to outline in a brief introductory letter and [Child 10] has been seen by a Consultant Paediatric Neurologist and a Principal Clinical Psychologist in addition to the Community Paediatrician and ENT surgeon.
However, the situation is so difficult and complex that I’ll be grateful for any help you can given. I would be happy to forward photocopies of any letters in my possession or of course you can liaise with the consultants directly.”
I think we heard, just to set the scene, that accompanying that letter were pages 36 to 56 of this set of notes. Stepping back for a moment, Dr Wakefield, that was the referral letter from Dr Hopkins. Did you know directly the family at this stage?
A I do not know. The father in particular was a friend of Mrs 2 and I believe he was alerted to our work following an article in a newspaper. It is possible that I had a conversation with him before, but I cannot remember it.
Q From what you can remember, are you able to help the Panel as to whether you had any involvement in the events and conversations leading up to this referral letter?
A If a conversation had taken place, it would have been along exactly the same lines as with other general practitioners. In other words, suggesting a referral of his son to Professor Walker-Smith.
Q Can you remember now – if you cannot, do say so – Mr 10 telling you anything at that stage about his son’s predicament?
A I cannot remember, I am afraid.
Q Following the letter of referral, let us look at what happened. Open the GP notes, please, at page 80. Professor Walker-Smith responded to that letter of 29 October 1996:
“Dear Dr Hopkins
Many thanks for your letter. I would be delighted to see [Child 10] and I have arranged for an outpatient appointment to be sent.”
Did you have any part to play in any decision by Professor Walker-Smith to arrange for an outpatient appointment?
Q The outpatient appointment you can find at page 17 of the Royal Free notes. That is 8 November 1996 and once again we see a Dr Murch stamp and writing underneath that. Again, just so we have as much completeness as possible, were you in a position to identify that writing?
A That is Professor Walker-Smith’s writing.
Q Did you have any role or part to play in that out-patient appointment?
A Other than as an observer, no.
Q Do you have a positive recollection of actually being there as an observer?
A I do not.
Q On page 33, following that out-patient appointment Professor Walker-Smith writes to Dr Hopkins. The date is 11 November and the reference is directly to the clinic on the 8th, which is in the top left-hand corner. It is copied to you. Professor Walker-Smith thanks Dr Hopkins for the referral:
“From a gastroenterological point of view it is interesting that he has intermittent episodes of watery diarrhoea and has episodes of screaming when he clutches his abdomen which could be related to abdominal pain. The parents are keen that I should investigate him for possible gastrointestinal disease, it is very interesting that he has a high measles antibody and I think that this needs to be taken into account with the possible relationship of measles immunisation and inflammatory bowel disease. I am therefore arranging for him to come in to have a colonoscopy on Sunday 12th January …”
Dr Wakefield, did you have any role or part to play in any decision to admit this child?
Q In particular, to admit for a colonoscopy?
Q When, as is the case here, and we have seen it in other documents, the expression “high measles antibody” is used, what is that the result of? I phrased that very badly. By which means does one come to that conclusion?
A This is a blood test.
Q What does it demonstrate?
A It is a measure of one aspect of the immune response of the child to the measles virus. I should add, a high level suggests that there is an ongoing vigorous immune response to that virus.
Q The child was admitted on 16 February 1997 and we can just see it simply as a milestone for the moment on the Royal Free notes. Did you take any part in the admission process of this child?
Q Did you take part in any of the planning on a ward basis for this child?
Q The child did undergo a series of investigations. Who did you understand was making such decisions?
A Professor Walker-Smith and his team.
Q A lumbar puncture was carried out. In fact, I just mention this in passing, the result is on page 64 of the Royal Free notes. It is probably best if you turn it up; do not just take it from me.
A (After a pause) Correct.
Q Was the performance of that lumbar puncture in any way the result of decision making or input into decision making by you?
Q Did you cause that lumbar puncture to be performed?
A No, I did not.
Q In terms of the sequence or order in which investigations were done, and with particular reference to the lumbar puncture in this case, did you have any input into those arrangements?
Q Whose responsibility did you understand that to be?
A This was a consensus arrived at again by the senior clinicians.
Q Did you have a view at that time, or indeed at any time thereafter, certainly leading up to the publication of The Lancet paper, as to the nature of these investigations?
A I felt that they were entirely clinically indicated.
Q Did you carry out any research on this child?
A Yes, I did.
Q What was it?
A It was an analysis of biopsies taken during the course of his routine clinical colonoscopy.
Q As far as you were concerned at the time, was Professor Walker-Smith and his clinical team engaged on research?
A No, they were not.
Q There are two references I would like you to look at, please, in relation to Dr Berelowitz. In the Royal Free notes, page 16, there is reference I think to
18 February 1997 at the bottom of the page:
“Seen by child psychiatrist
Detailed report to follow
You will see at page 28 a report, dated 20 February 1997, from Dr Berelowitz. It is addressed to Professor Walker-Smith, “Dear John”, signed by him and copied to you. We can see that at the bottom of page 29.
Q He says in the first paragraph:
“I saw [Child 10] … on 18th February, 1997. In fact I saw [Mr 10] only as [Child 10] was sleeping, and father said mother would not wish to participate in a research interview.”
As matters stood in February 1997 was the concept of a research interview in play, if I could put it that way?
A No. It is a little confusing. The research contribution that Dr Berelowitz was to make was the ADI, the autism diagnostic interview, and I think it is the CAPA which is an acronym for another standardised child developmental assessment. It was our understanding – I speak for myself, perhaps I should not speak for the others, they can offer their opinion – that he was being asked to provide a routine assessment of these children by way of assisting with their differential diagnosis in terms of their development. So I have to confess I am a little confused in this respect.
Q The ADI that you refer to you have referred to earlier in your evidence, because it appears in the material which was submitted to the ethical committee in September 1996.
Q Just remind us, please, what was the intention as matters stood in September 1996 in relation to ADI and Dr Berelowitz?
A Again, it was my understanding that since he had seen, read, approved and signed the protocol document which made him responsible for the conduct of the ADI, that he, or possibly someone under his direction, would be performing that test. That was my understanding.
Q In terms of the ADI I think you told the Panel earlier that that was a research endeavour which would have needed ethical committee approval?
A For our purposes, yes.
Q That is all I ask you in relation to those documents and I turn finally to the backdrop of the live charges. That is head of charge 29(a) and (b). Again, I just want to draw the threads together. What research investigations were being carried out in relation to this child?
A Laboratory based analysis of intestinal biopsies taken during the course of his routine clinical colonoscopy.
Q As to the other investigations which you have identified, again were they to be characterised in your view, as matters stood at that time, as research investigations?
Q In relation to the investigations you have identified as being research investigations, did they require EC approval?
Q Did you have it?
Q What was it?
Q Moving on to the issue of entry requirements or inclusion criteria, the backdrop is head 29(b)(i), 29(b)(ii). Were they relevant?
Q The subject matter of the consent forms. I think you will need to have supplied to you the second volume of the Royal Free notes. In relation to the investigations which you have described as clinical and non-research investigations, would you expect there to be appropriate consent forms?
Q If you turn to page 15, how do you characterise that document?
A This is a Royal Free Hampstead NHS Trust consent form for routine investigation, in this case colonoscopy and lumbar puncture.
Q Is that what you would expect in terms of a purely clinical investigation?
Q In relation to the research investigations that you have described, the biopsy followed by analyses in the laboratory, would you expect and require a consent form for that activity.
Q Turn to page 20. What is that?
A This is a consent form for research biopsies pursuant of 162/95.
Q Is that what you would expect there to be in this case in relation to what you were doing?
Q Would you have expected any other sort of consent form, again my expression, any overarching consent form, to apply to the totality of investigations?
Q I have two short matters. In relation to The Lancet publication, when it came to you to play your part in the drafting of it, what materials were available?
A As with all the other children I had his full contemporaneous clinical record,
I believe I had early developmental records and in addition the standardised proforma, the histopathology assessment, designed and completed by Dr Dhillon.
Q Finally this, the question of legal aid. Can you tell the Panel, please, what your state of knowledge was, if any, about the issue of legal aid in relation to this child?
A We had no knowledge of legal aid at the time of his referral for this investigation. I believe at some stage after that he applied for legal aid and it was obtained, but I cannot tell you when.
Q Then going back to the time of referral and investigation, did you have any appreciation of the father or parental motivation on the litigation front?
A They were not motivated by litigation at all as far as I was concerned.
MR COONAN: That is all I ask you about Child 10.
THE CHAIRMAN: I think this is probably the right time to adjourn. It is ten past three and we will resume at half past three.
(The Panel adjourned for a short time)
THE CHAIRMAN: Mr Coonan?
MR COONAN: Sir, could I just direct you to the evidence in chief scheme – the route map, as I have called it. You will see ---
THE CHAIRMAN: Is that D7?
MR COONAN: D7. I had as an adjunct to Child 10 at the time that we drafted this intended to deal with transfer factor. I have decided to do it not as an adjunct to child 10 but deal with it as a separate issue because it cuts across two issues in the series of charges in relation to Dr Wakefield. I think you may find it more helpful if it was dealt with all of a piece, rather than chopping amongst different areas.
What I am going to do now is begin Child 12 with Dr Wakefield; deal with Child JS and then deal with transfer factor, and that will deal with all those in section 9. That is the order at present that I intend to adopt. Dr Wakefield will have heard me say this for the first time, and I hope that does not take him by surprise.
Child 12. You will need the GP notes and the Royal Free notes. For obvious reasons, I am going to keep an eye on the clock, or try to.
THE CHAIRMAN: Never mind. I will remind you!
MR COONAN: Dr Wakefield, can we begin, then, by looking at the GP bundle at page 124, Child 12. I am going to start with this letter and then, as I have done before, step back and deal with the background. This letter, written by Dr Stuart, Child 12’s general practitioner, though it says “Dear Mr Wakefield”, is then addressed to “Professor Walker-Smith” and then, underneath that, “For the Attention of Mr A J Wakefield”.
“Thank you for seeing [Child 12] who we have discussed on the phone recently.”
She then rehearses the history in summary form, highlights the fact that he had a routine MMR vaccine in March 1992.
“He has for some time had bowel problems, but did not present to my surgery until March this year when Mrs 12 came along to discuss his soiling habit.”
He carried out an examination. At the end:
“I look forward to hearing your opinion regarding [Child 12’s] further investigation and outlook.”
Had you had any contact, first, with Mrs 12?
Q We can juggle two letters here, but if you go to page 126, it is a letter from you. It is earlier in time – you see 19 July 1996:
“Dear Mrs 12
Thank you for your letter regarding your son.”
We do not have a letter in the bundle, but can you remember, first, two things. How did the first contact come about?
A Mrs 12 had met the mother of Children 6 and 7 at a playgroup, and they had got into conversation about their children, and their children’s developmental problems. The mother of Children 6 and 7 had informed Mrs 12 of the fact that she had taken her children to the Royal Free, and had received help and effective treatment for their problems. She was seeking a similar referral by making contact with me.
Q Was that contact oral contact, or was that the contact by letter referred to on page 126?
A I think it would be the letter that she refers to here.
Q And what degree of detail and background and history did she set out in the letter?
A I do not remember specifically, but I do remember of this child a very similar history of normal early development, of developmental problems following the MMR vaccination, which the mother did not, and had not at the time, ascribed to the MMR vaccine exposure. She never made that association. The striking element of her story of her son was the development of secondary incontinence. He had gained continence, faecal continence, at an early stage and had lost this. That was reminiscent of the description to us of disintegrative disorder by Dr Berelowitz.
Q Let us look at what you say to her in reply to her letter.
“We have recently taken a profound interest in this subject, particularly in view of the link between bowel problems and Asperger’s Syndrome. I would greatly appreciate if you would mind calling me at the Royal Free before 3rd August and in addition I would like you to seek a referral from your GP to Professor John Walker-Smith, Professor of Paediatric Gastroenterology at the Royal Free Hospital, for investigation. It will be necessary for me to discuss the nature of the referral with your GP and I would be very grateful if you could let me have his/her name telephone number. Also could you please let me have your telephone number so that I can speak to you directly on the subject.”
Again, taking that in its constituent parts, do you remember following that letter up with a telephone call with Mrs 12?
A Yes. I have a vague memory of that.
Q Do you remember whether you called her or she called you?
A She will have called me, according to my instruction here.
Q And why did you judge it appropriate to make the suggestion of her telephoning you?
A I think her letter raised several questions, some of a general nature which was probably able to deal with effectively over the phone, and also to try and reinforce the process that would be necessary. She was requesting a referral and there had been so many mistakes made in the process of referral to this point. Again, it is not a criticism; it is a very complex situation. Nonetheless, there had been so many mistakes made in that process, and I wanted to try and reinforce how such a referral that she was requesting should, in fact, take place.
Q Leaving the telephone conversation to one side, the next element is in the fourth line where you say, “…I would like you to seek a referral from your GP to Professor John Walker-Smith …” What about the apparent emphasis of the language?
A She has requested a referral and I am trying to be absolutely clear about who should make the referral and to whom
Q And then, on the next line:
“It will be necessary for me to discuss the nature of the referral with your GP…”
Again, what about the apparent emphasis of the language?
A Again, there had been a litany of errors, and I wanted to try and make sure that did not happen again. In fact – and I will be very quick – as we see from the doctor’s letter, it did happen again, and the referral was made to me, albeit addressed to Professor Walker-Smith’s department. Beyond this point, as Mr Coonan had pointed out, we decided – Professor Walker-Smith and I – to produce a letter, a very detailed letter of the background to this investigation and how the referral should be made that went out after this patient, which tried to remove this kind of error from the process.
Q Again, as I indicated the other day, we will come to that in due course. Can I just then deal with matters as they then stood. You have had a letter addressed to you from Mrs 12. You have spoken to her on the telephone. Was there any attempt by you to persuade Mrs 12 to go forward and have her child investigated at the Royal Free?
Q When the referral letter was sent, which was in September and the original letter was in July, had you had a conversation with Dr Stuart, do you remember?
A Yes, I think I had.
Q What role were you adopting in speaking to Dr Stuart?
A In exactly the same way as with other general practitioners, my role was to provide them with the background information in a generic sense that enabled them to judge the merits of making a referral to Professor Walker-Smith.
Q If we can just bear in mind the dates we have just been looking at and turn back in the notes to page 11 of the GP notes. I am not suggesting this is a document you would have seen at the time. Halfway down the page – the date is a little obscured in the photocopying, but I think it is 20 or 24 July; others may be able to help – it reads:
“Call from Dr Wakefield – needs colonoscopy. B12 absorption test. [History of] measles vaccination reaction.”
Does that accord with your recollection of events at that time?
A I do not remember this. It is the doctor’s annotation. I do not remember this mother ever ascribing her child’s problem specifically to a vaccine reaction and so this may reflect a generic perspective, if you like, of the overall background rather than something relative to this specific child. I cannot say more than that.
Q You have a memory – is this your evidence? – of speaking to Dr Stuart yourself in or about July?
Q I need you to put that aside and take volume 1 of the Panel bundle and turn, please, to page 129. This is a letter from Dawbarns to Mrs 12 and it is dated 18 July 1996, so at roughly the time when there was contact between Mrs 12 and you, as we have seen. Is that right?
Q Dawbarns write to her:
“Thank you for contacting us regarding the MMR vaccination. We are investigating a number of vaccine damage cases and are also (with Messrs Freeth Cartwright Hung Dickins of Nottingham) co-ordinating and managing the Mumps Measles and Rubella cases on behalf of the Legal Aid Board for the whole country. Recently the Legal Aid Board has also extended our contract to investigate claims following the government’s measles/rubella vaccination campaign in the autumn of 1994.”
In July, at the time of your contact with her, did you know that she had had a contact with Dawbarns?
A No, I did not.
Q Were you aware of any – and this is my phraseology – litigation motivation by the mother at that stage in July 1996?
Q In the same bundle at page 147, as of August 1996, another letter from Dawbarns to Mrs 12 headed “Vaccine Damage Compensation Claim. Legal Aid for [Child 12]”. The preliminary parts of this letter – I am just summarising – indicate in paragraph 2 that this solicitor is putting together a legal aid statement for Child 12 based, as he says, very largely on what you have actually said. Then in the third paragraph:
“I noticed in your statement that you made references to [Child 12’s] intestinal problems and I enclose a copy of a fact sheet from Dr Andrew Wakefield who is investigating the link between inflammatory bowel disease and the MMR vaccine.”
As matters stood at that time, had you in fact prepared – he has described it as a fact sheet – a document of that nature for Dawbarns?
A No, not for Dawbarns. I had, following the publication of our paper in The Lancet linking or possibly linking measles vaccines to inflammatory bowel disease, I had received an enormous number of calls from parents. As a consequence and as a way of dealing with that, I had produced a fact sheet for parents and general practitioners. I provided, I am sure, a copy of that to Dawbarns to send out to anyone who might be interested. I do not remember doing that, but I have no reason to suspect that I did not and no reason for not doing it, and I think this is what he is referring to there.
Q I just want to understand therefore, such a document as you prepared, was that prepared for the purposes of prospective litigation?
A No, absolutely not.
Q Was it prepared in respect of prospective litigation for any child, leaving aside any of these children?
Q If necessary, keep a finger in that page and look at page 152. Is that the document that you have been referring to just now in your evidence?
A Yes, it is. There is an important forensic point in this, and that is, if one looks at page 154 and the reference to Ekborn et al, you see that the date is 1996 and that is submitted for publication. In other words, that paper, which was subsequently to be published in The Lancet, had not at that stage been published. So this was produced some years before, or some time before.
Q Again, if necessary, keep a finger in that and go back to Dawbarns letter at page 147. As Mr Barr says in the third paragraph:
“I enclose a copy of a fact sheet from Dr Andrew Wakefield …”
In our bundle, it follows on immediately from that letter. I want to be clear going forward, because the terminology “newsletter”, “fact sheet” and so forth has been used in these documents by various people at various times. This is your document at page 152. How would you describe that, please, just so that we do not get into the territory of confusion?
A I would call this an information sheet or information document.
Q You can put volume 1 to one side, please. Could you go back to the GP bundle and turn to page 118? I just want to pick up and identify what happened in relation to the letter of referral which we have looked at at page 124 dated 23 September. This document is now 27 September written by Professor Walker-Smith to Dr Stuart:
“Many thanks for your letter. I will be delighted to see [Child 12] and I have arranged for an outpatient appointment to be sent.”
This is Professor Walker-Smith agreeing and arranging for an outpatient appointment to be sent. Did you have any role or part to play in that decision making?
Q An outpatient appointment did take place. Can we just flag it up, please, on page 12 of the Royal Free records? 18 October 1996. Once again we have the Dr Murch stamp and the writing underneath the stamps. Again, do you recognise that writing?
A That is Professor Walker-Smith’s writing.
Q Did you take any part in that outpatient appointment?
A Other than possibly as an observer, no, I did not.
Q Over the page at page 13, again I am not going to go through all the detail. It may be that Professor Walker-Smith can help us about the fine detail when he gives evidence. Under the examination section on page 13 we see a notation for FBC and ESR, C-reactive protein. Is that right?
Q Again, did you have any input at all into any management aspect of this outpatient appointment?
MR COONAN: I see the time. I wonder whether that might be a convenient moment?
THE CHAIRMAN: Yes, I am quite sure that it will be a convenient moment. Thank you again for being very meticulous with the timing. We will now adjourn and resume tomorrow morning at 9.30 and, Dr Wakefield, you are still under oath and still in the middle of giving evidence.
(The Panel adjourned until 9.30 a.m. on Thursday, 3 April 2008)