GENERAL MEDICAL COUNCIL
FITNESS TO PRACTISE PANEL (MISCONDUCT)
Tuesday 1 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, everyone. Once again, can I just remind everyone to make sure that their mobiles are switched off? Mr Coonan?
ANDREW JEREMY WAKEFIELD
Examined by MR COONAN, Continued
Q Dr Wakefield, I am now going to turn to Child 1. Can we begin, please, with the referral letter itself, which you will find in the Royal Free bundle at page 57. Dr Barrow was the general practitioner and the referral letter is dated 17 May 1996. Just before we look at the content, the letter also had enclosed with it pages 58 to 62. We see the reference to that in the last two lines. Looking at the body of the letter, which is addressed to
Dr John Walker-Smith:
“I understand that [Mr and Mrs 1] have contacted you regarding their youngest son …
Then the doctor sets out a number of the background clinical features.
“[Mr and Mrs 1’s] most recent concern is that the MMR vaccination given to their son may be responsible for the autism.”
Then just in order to give the complete background, keep that open, would you, and turn up the GP records to page 125. This is a letter written to the Senior Medical Officer at XXX:
“Dear Dr Haughton
I would like you to refer our son …. to the below address immediately. A severe metabolic disorder needs tests done.”
Then the name and address given is John Walker-Smith, Paediatric Gastroenterologist, The Royal Free Hospital. If you put that to one side, we have then in those documents evidence of contact between the mother and the general practitioner. The question I would like to ask you against that background is: did you have any contact with the parents prior to the referral letter?
A Yes. I do not remember it, but I believe the mother called me after reading a newspaper article relating to the observation of a possible association between measles virus and Crohn’s disease.
Q What did the mother say to you?
A She described to me in her child a very similar story to that of other parents. Her normally developing child had received his MMR vaccine during the second year of life and had undergone a developmental regression, had been diagnosed with autism and had at the same time developed gastrointestinal problems.
Q What, if any, advice did you give the mother?
A The other aspect of her description was one of secondary incontinence. Her child had gained faecal continence in particular at an early stage and this was lost. This description was reminiscent of Professor Rutter’s description of childhood disintegrative disorder and with Dr Berelowitz’s reiteration of that. So I suggested, as with all other parents, that while I was unable to offer any help myself, Professor Walker-Smith may be in a position to advice upon the clinical aspects of their problem.
Q If one looks at the attached pages at 58 to 62, particularly page 58, does that background information accord with what you recall the mother telling you?
A Some of it at least is there. The secondary incontinence is not referred to, but nonetheless the rest is consistent.
Q Did you have any contact at that stage with the GP?
A No. As with other parents, I offered, if it was necessary, to explain in a generic sense what we thought might be going on by way of background, but in this instance I do not think that was necessary. I recommended that she seek a referral via her general practitioner to Professor Walker-Smith and that seems to have been the case.
Q Was there any apparent litigation motive being expressed by the mother to you?
A Not at all. It was not mentioned.
Q How would you describe your role vis à vis the parent in this case?
A I merely acted as a signpost, a conduit, if you like, for channelling their concerns to someone who could potentially help them clinically.
Q Let us move on to what happened next. Turn back to the Royal Free notes at page 55, please. On 23 May Professor Walker-Smith then writes back to the general practitioner thanking him for the letter of referral:
“I was delighted to see [Child 1] and I have arranged for an out patient appointment to be sent.”
Dr Wakefield, did you have any role to play in that decision by Professor Walker-Smith?
Q On 20 June, an outpatient appointment took place and, if you turn back to page 13, you will see a note relating to the out patient appointment, which again I am taking to be Professor Walker-Smith’s writing. If that is right, we can ask him about the content of it. At that outpatient appointment, did you have any role to play?
A Other than as an observer, no, I did not.
Q Do you remember being an observer at this outpatient clinic?
A I am afraid I do not.
Q Just so the Panel understand your position on this. Are you excluding the possibility that you might have been there?
A Not at all, no. It was fully my intention to be present during these evaluations.
Q The following day, Professor Walker-Smith wrote two letters, one to the GP and one to yourself. Let us look at both of them, please. Take the first one, the one to Dr Barrow, at page 54 in the Royal Free bundle. The letter, as I say, is dated 21 June and in the top left-hand corner there is a reference to a clinic. That may be a typo, but no matter. Let us look at the body of the letter:
“Many thanks for referring [Child 1] with autism. It is difficult to associate a clear historical link with the MMR and the autism although [Mrs 1] does believe that her son had an illness 7-10 days after MMR when he was pale, ? fever, clearly delirious, but wasn’t actually seen by a doctor …”,
and so on. Did that information there, that history, accord with what the mother told you?
Q He goes on:
“It is very interesting that he has a 5 year old brother who has also been diagnosed as part of the autistic continuum. As part of Dr Wakefield’s and my interest in the relationship between immunisation and chronic inflammatory bowel disease, I have arranged for a routine blood test to be done for screening for C-reactive protein …”
et cetera. Just two questions. Did you have any role in the clinical decision to organise a routine blood test?
Q Is Professor Walker-Smith correct to describe, as he does, that Dr Wakefield and he had an interest in the relationship between immunisation and chronic inflammatory bowel disease? Is that a correct and accurate statement of affairs?
Q I am looking at the last paragraph:
“My plan would be to see him again in three months’ time. Then if [Mrs 1] feels that it is appropriate, we could consider performing endoscopy and further assessments neurologically and psychologically of his autism to explore the possible link between measles immunisation, viral inflammation and autism.”
Again, did you have any role in that planning?
A No, I did not.
Q Would you like to comment to the Panel, please, on the purpose underlying the possible future execution of the plan? In other words, the exploration of a possible link between measles immunisation, viral inflammation and autism. In particular, please, can you address the question of whether you understand that to be a research question or a clinical question?
A The motivation for seeing and investigating this child was purely a clinical one in the first instance. This is a standard clinical referral, assessment and response and it is very deliberate and considered; there is no rush. There is the intention to conduct routine blood tests for screening for inflammation and other abnormalities that might be indicative of bowel inflammation or other abnormalities and the intention to review.
Q I do not know whether you saw this letter at the time.
A I do not remember it.
Q At page 53 there is a letter to yourself of the same date from Professor Walker-Smith:
“ I saw this interesting child with autism which began some weeks following MMR … [Mrs 1] was keen that you would have a look at a document that she got concerning homeopathic remedies and I am passing this on to you.”
Two questions, please. Why might you be interested in receiving a document relating to homeopathic remedies?
A I do not know. I know nothing about homeopathy and I have no specific interest in it, but I know that Mrs 1 did and I imagine that Professor Walker-Smith is acting on the request of Mrs 1 to pass this to me, and that is what he does.
Q The next question is one which applies in many respects in other cases and the Panel will be astute to observe it when it occurs. Why is Professor Walker-Smith writing to you sometimes with the results of outpatient appointments and so forth?
A I think that he is aware, since we have been discussing this for some time, of my interest and he is doing me the courtesy of keeping me informed.
Q In July, Child 1 was admitted to the Royal Free. If you turn back in the bundle, you will see the admission notes. This is 21 July 1996. Could I just mention that there is a small typographical error in the chronology, sir? We have put down for the admission of Child 1 RNH 11. In fact RNH 11 is part of the documents, but in fact the commencement date was RF9. We have these notes. These are not your notes, Dr Wakefield. We have heard that. Did you play any role in the clerking in of this child?
Q At the top of the page, in the first line, it says: “Referred for work up of ? relationship between autism, measles, IBD.” Is there anything you want to comment on on that? I know it is not your note.
A No. I believe this is Dr Casson’s writing and Dr Casson had been part of our joint interdisciplinary group meetings, that is, between my group and Professor Walker-Smith’s group on Tuesday lunchtimes. This is an entirely reasonable assessment from his perspective of what the position is. It does not in any way imply a primary research issue. It is his take, I imagine, on what this child is being admitted for.
Q Did you anticipate yourself exercising a research function when this child was in hospital?
A If, as was the case, it was deemed necessary to conduct a colonoscopy and biopsies would be obtained, and it would be possible that I would be performing research, tests on those biopsies.
Q Perhaps we can deal with this point in this case in the light of what you have said. Did you have any role at any time in determining whether a child should have a colonoscopy?
Q So we have it absolutely clear, whose decision was that?
A Professor Walker-Smith.
Q We know that a colonoscopy was carried out in this case. What do you understand to be the purpose of that colonoscopy?
A I stand to be corrected on this – it is a clinical matter – but I believe that the screening tests identified an anaemia in this child. I think the haemoglobin – and again, as I say, I stand to be corrected – was about 10.7 and that is low. Therefore, that finding against the history given by the mother was suggestive of a possible inflammatory bowel disease and therefore he was undergoing colonoscopy for the exclusion of intestinal inflammation, in particular the possibility of Crohn’s disease or ulcerative colitis.
MS SMITH: Sir, excuse me. I am sorry to interrupt Mr Coonan but I wonder if I can just make an intervention at this point. Using the language that Mr Coonan used with me, you may recall, at the previous hearing, it seems to be that he is verging – and I use the word “verging” – on using Dr Wakefield as an expert on matters which Dr Wakefield himself is saying were not for him. I am simply raising this at this point. As I say, I apologise for interrupting but I am raising it now because I want Mr Coonan to be aware that I shall continue to object if he goes through these children’s records, as I say, asking Dr Wakefield for an expert opinion on matters which it appears to be Dr Wakefield’s case are all clinical and therefore for Professor Walker-Smith. If he wants to deal with those matters he should call an expert to deal with them and, by the way, he should have cross-examined the experts who were called by the General Medical Council.
THE CHAIRMAN: Mr Coonan?
MR COONAN: That is absurd, and I do not shrink from saying it is utterly absurd. What I am asking Dr Wakefield is not to put on a clinical hat but to seek from him an opinion as to whether, at the bottom, he believed at the time that these investigations were clinically justified. That is an important factor, relevant to this case. That being a proper issue I am then entitled to ask him on what basis he thought that this was clinically justified. That is what I am doing.
THE CHAIRMAN: Legal Assessor?
THE LEGAL ASSESSOR: Dr Wakefield is entitled to say what his state of mind was at the time and why he took particular actions and he is entitled to give his reasons for doing that. He would not, however, be entitled to comment, in effect make himself an expert, on his own lack of expertise, as it were. My advice is that Mr Coonan is entitled, to the limited extent, to explore what was in Dr Wakefield’s mind for any action he took and as to why he took it, but he should not take it further than that.
THE CHAIRMAN: Ms Smith, are you content with that?
MS SMITH: I am entirely content with that. That was the point that I was making.
THE CHAIRMAN: Thank you very much. Mr Coonan?
MR COONAN: Indeed, I am content with that, which is precisely the approach that I was adopting. (To the witness) Let us get back on track, Dr Wakefield. Let us go back please so the point is not blunted by the intervention. I ask you again, when the colonoscopy was carried out did you believe that this investigation was or was not clinically justified?
A It was in my opinion entirely clinically justified.
Q That is the colonoscopy. The other investigations that were carried out – lumbar puncture, MRI and EEG and evoked potentials (there may have been others but those were the ones I am particularly concerned about) – who made the decision that those investigations be carried out?
A Professor Walker-Smith.
Q Did you have any role to play in that decision making?
A None whatsoever.
Q So far as the lumbar puncture is concerned we see a reference to this at RF15 and we also see a reference to EEG and EPs. Right?
Q At the time or round about the time when you had any dealings with this child did you have a view at that time as to whether or not a decision to carry out a lumbar puncture was clinically justified?
A Yes, after a long consideration and discussion between colleagues, after the introduction of the Birmingham Children’s Hospital clinical protocol for the exclusion of mitochondrial cytopathy or measles infection, the brain, after discussion with Dr Harvey and in particular in the presence of a history of developmental regression suggesting a possible disintegrative disorder, then this investigation was clearly indicated.
Q Did you take the view at the time that the MRI investigation was clinically justified?
A For similar reasons, yes.
Q And the EEG and evoked potentials, what about those?
A For similar reasons, yes.
Q Following that admission we can see a discharge summary at page 49. There are two aspects of that I would like to ask you about, particularly since the document was copied to you. We can see that at the bottom of page 51.
Q Go back to page 49, the first three lines:
“[Child 1] was admitted for further investigation of his autism and specifically to look into a possible association between his neurological condition and any gastro-intestinal disorders.”
Then at the bottom of page 50:
“We would like to review [Child 1] in clinic to discuss the implication of the mild degree of inflammation seen in his biopsies. It is also not entirely clear whether his neurological condition in fact represents a neurological deterioration in view of lost milestones, or whether it is a classical autistic picture.”
Taking the first page first and that sentence, when you received that document did you consider that to be an accurate analysis of the situation?
A Yes, I thought this was a very reasonable, typical clinical discharge summary.
Q In relation to the last page, was any of that analysis or comment your comment?
A None of it.
Q The day before Dr Casson, who wrote the discharge summary, also wrote to you. Can you turn on to page 52 please? This is Dr Casson to yourself:
When would you like us to review this patient again and are there any other procedures we should be performing?”
When you received that letter how did you respond to it?
A David Casson was at the time, as the Panel will now be aware, a junior member of Professor Walker-Smith’s department and I think particularly in the case of these early children, the children that we saw at the very beginning of this process, there are a number of letters to me in this sort of vein. I think he may have been confused about my role, and that is understandable inasmuch that my position was somewhat unique in the Royal Free. I did not respond. You will notice that in the records there is no response from me because it was not my place to respond suggesting clinical management, further investigations of a clinical nature or otherwise. If Dr Casson was by these letters referring to research matters that is entirely different, but it is his letter and I cannot speak to that. Nonetheless, there are no responses from me, because that is not appropriate, other than verbal responses to say I am not clinically involved and after a while such letters cease appearing in the records.
Q There are altogether four, and we will look at them. Later in August, on the 30th, if you turn to page 48, there is a letter which we will just look at carefully. This is a letter written to Dr Barrow by Professor Walker-Smith and copied to you, at the bottom. Do you see that?
“Further to the discharge summary sent to you concerning [Child 1], [Mrs 1] was unable to keep her Outpatient appointment yesterday, but I have spoken to her on the telephone … I suggest a therapeutic trial …”,
and he sets out the medication.
“I should be grateful if you could prescribe this dose …”,
and then in the last paragraph he says this:
“I have not planned to see him again but Dr Wakefield will be assessing the research aspects of this problem and I would be happy to give further advice.”
As I say, copied to you. When you received that letter, how did you interpret or respond or react to what Professor Walker-Smith was saying about your role?
A What Professor Walker-Smith sets out here very clearly is the distinction. Firstly, that this is the standard management, the clinical management of a child with this sort of presentation. He is recommending treatment based upon the detection of inflammation, and I should come back to that in a moment. He is also separating out the clinical issue very clearly from the research issue, which is my responsibility, and saying that I will be assessing the research aspects of this (that is, the biopsy analysis) and he is also providing an opportunity for the doctor to make contact, re-refer the child if necessary. I just want to emphasise that the finding of focal active colitis (that is, inflammation) in this first child was I think a surprise to everyone and really changed our perception of what might be going on in these children and was certainly influential in that process. I do not think any of us necessarily expected it and there it was and it set the bar, if you like, for the approach to this sort of problem for the future.
Q Two months later, if you turn, please, to page 47, arrangements are made for a second admission and Dr Casson is writing to the mother. The first paragraph is self-evident, and in the second paragraph he says:
“He is due to have a barium meal and follow-through on Wednesday. He will have an EEG and evoked potentials … This will be performed under sedation. In association with this, whilst still sedated, he will need a lumbar puncture. During the admission various blood tests will also be taken …”.
In relation to arrangements for the second admission did you have any role to play?
Q Can I look, please, at a couple of matters which relate to potential clinical involvement of either you or others in the admission as a whole, but first during the first admission in July? Can we turn now, please, to page 134(a)?
THE CHAIRMAN: I do not think I have got 134(a).
MS SMITH: I do not, but I can look at Mr Thomas’s.
MR COONAN: It should be (a), (b) and (c). May I ask, Dr Wakefield, is it in your bundle?
A I do not have it.
THE CHAIRMAN: I think it will probably be better if we just pause until these are copied and circulated. (Long pause while copies are made) I am sorry. I think these are three pages, but I am not quite sure – does Dr Wakefield have these three pages?
A Yes, I do.
THE CHAIRMAN: Right. So this is 134(a), 134(b) and 134(c).
MR COONAN: Have you had an opportunity of just looking at them, Dr Wakefield?
A Yes, I have.
Q Although the top of the photocopy on 134(a) says “Royal Free Hampstead NHS Trust – X-ray”, do you think it is possible to see that there is a request form which is on top of that, which has been photocopied. Is that right?
Q What I am concerned about is the request form. Keep a finger on that and turn back to page 94. Do you see the number on the top right-hand corner – the test number – F3593, and the report number on the top of page 94, and there also appears to be a photocopy of that which is on page 134(a). Does that appear to be the case?
Q Since we have 1354(a) in, let us look at that. Is any of the writing on that form yours?
Q If you turn into 134(b), you will see coupled with that 134(c) for the result, those two are to be read together. Go back to 134(b), is any of the writing on that document yours?
Q Page 26, please. We are now in July 1998, and at the top of the page in a stamp which has not been photocopied terribly well again there is a reference to “Wakefield clinic”, do you recognise the writing underneath that?
A It is Professor Walker-Smith’s writing.
Q Did you have a clinic on that day?
A I did not have a clinic.
Q That is all I am going to ask you about the records in terms of the main issues, save for a couple of other references, but I want now just to turn, please, to the structure of the relevant charges. I am not going to go through each of them slavishly, but the Panel will be able to address this by looking at head of charge 11 as we go through it. With heads of charge 11(a) and 11(b) in mind, just as a backdrop, as far as you are concerned, what research elements were taking place in respect of this child?
A Biopsies were procured and I undertook research on those biopsies.
Q Did you need ethics committee approval for those elements of research?
Q And did you have it at that time?
Q And what was it?
A Under 162-95.
Q As far as you were concerned at that time, was Professor Walker-Smith engaged in research, and by Professor Walker-Smith I include his team. Do you understand? Were they involved in research?
A No. Their primary objective was purely clinical.
Q I am now considering head of charge 11(c)(i), was a start date relevant?
Q Was the issue of entry criteria relevant?
Q That is head of charge 11(c)(ii) and 11(c)(iii). I am going to turn to consent forms. That is head of charge 11(d). Were consent forms required here for clinical investigations?
A It is my understanding that for certain clinical investigations consent forms were required, yes.
Q Can we look to see whether or not they exist? Take the Royal Free bundle again and look at page 93. Is that what you would understand to be a consent form for clinical investigations or not?
Q Page 88.
Q How do you read the status of that?
A This is a standard Royal Free Hampstead NHS Trust consent form for a clinical procedure which in this case is colonoscopy and biopsy.
Q At page 91.
A Again, this is a standard Royal Free Hampstead NHS Trust consent form for a clinical investigation, in this case lumbar puncture under sedation.
Q So far as any research aspect is concerned, in other words the taking of biopsies for research and any research flowing from that, would you expect there to be consent forms for that activity?
A Yes, I would.
Q Would you turn to page 42. What do you understand the status of that to be?
A This is the consent for research biopsies which is part of the approval 162-95.
Q We see the date on that, 25 July 1996. Would you turn to page 89. This is a document dated 21 July 1996. Again, the status of that, please?
A Again, this is a consent for research biopsies under the same EPC approval 162-95.
Q As far as you were concerned, was there any requirement to have a consent form in respect of any of the activities that we have been looking at in the round for the purposes of research?
A In as much as they related to the conduct of research on biopsies, which are both here, yes.
Q But apart from that?
A Apart from that, no.
Q I should go this far. Was there any obligation on you to ensure the placing of a consent form relating to other matters in this child’s clinical notes?
A No. This is not part of my responsibility.
Q And a wholly separate matter now, please – the question of Legal Aid. Can you just reach for the GP records and turn to page 74. This is in June 1997 and it is a letter from Dawbarns to the general practitioner at that time, on 4 June. Dawbarns says:
“We are acting for the parents of [Child 1]. Legal Aid has been granted to enable us to investigate a claim for compensation following injury which appears to have been caused by a vaccination.”
On the assumption that that fact is correct, that the child had been granted Legal Aid, at any time prior to this child’s investigation, did you know that?
Q Did you, can you recall, ever come to know that he had been granted Legal Aid?
A I may well have become aware of it some time around the sending of this letter, because I imagine that this was sent soon after Legal Aid was awarded but other than that, no, I have no memory.
Q Did this child become one of what we have been calling for shorthand purposes “The Legal Aid Board 5”? Can you remember?
A I do not think so, and I think the reason is that ileal biopsies – these are the biopsies in which the swelling of the lymph glands was observed – were not obtained in this child for technical reasons.
Q Finally this. When you came to be involved in the writing up of The Lancet, which we are going to look at separately, can you just remind the Panel, please, and tell the Panel what materials you had available to you when you embarked on that task?
A I had the entire clinical record from the Royal Free Hospital and so it was based on a distillation of the entire clinical record available to us at that time. The other thing that we sought to gather was information on early development. You will remember this comes in the form of the red book. I think it was read at the time. That is a child’s development record – their height, their weight, their growth parameters, their acquisition of various developmental skills. A copy of that was taken at the time, or the findings in that were noted down at the time so that we could confirm or check against the parental history the health visitor’s or the GP’s record of normal or abnormal early development.
Q Thank you very much. That is all I am going to ask you about Child 1. The next child, sir, is Child 3. The Royal Free notes predominate, and with a couple of references to the GP notes. Can we look first of all, Dr Wakefield, in the Royal Free notes at page 56. This is a letter from Dr Shantha, who was the general practitioner, on 19 February 1996 to Professor Walker-Smith.
“Thank you for asking to see this young boy who developed behavioural problems of autistic nature, severe constipation and learning difficulties after MMR vaccination. …”
I leave out the next sentence. Then there is a reference to severe constipation.
“The parents are very convinced that the difficulties in his behaviour etc. started only after the vaccination.
I am extremely for you to have taken on Child 3 for case study.”
That, of course, is a letter to Professor Walker-Smith and we can ask him about aspects of this. I want to know, please, from you whether you had any contact with the parents of this child before that referral letter?
A I do not specifically remember it, but I think it is very likely.
Q Would that have been a contact from a parent to you, or from you to a parent?
A From the parent to me.
Q This was in February 1996. Can you help the Panel as to whether you have any memory of any conversation with a parent at about this time?
A I do not.
Q In so far as you had contact with the parent, what role would you have been adopting?
A Again, the purpose of the parent contacting me will have been to seek help for their child, in this case for his gastrointestinal problems. I was not in a position to offer help personally but, once again, Professor Walker-Smith was in that position. So I was a signpost, again, to the parent, to seek a referral if that is what they wanted from their general practitioner to see Professor Walker-Smith.
Q Just so the Panel have the full picture, there is a note in the GP record at page 43. I do not ask for your comment. It is just to help the Panel to slot it in. It is a note by Dr Shantha for 19 February – half way down the page. Did you have any contact with Dr Shantha?
A No, I did not.
Q On page 57, Professor Walker-Smith writes to Dr Shantha thanking her for the referral letter and he says:
“I would be delighted to see [Child 3] and I have arranged for an outpatient appointment to be sent.”
Did you play any role or any part in that decision by Professor Walker-Smith to see this child?
A No, I did not.
Q The first outpatient appointment we can see occurred on 3 April 1996. If you turn to page 9, again, do you have any memory of playing any part in this outpatient appointment?
A No. I played no part in this appointment.
Q At the top of page 10, there is a note in relation to this outpatient appointment:
“Social services told parents that MMR might have caused problems. Recommended JABS – Dr Wakefield.”
Again, does that jog your memory at all about any conversation you may have had with the parents prior to referral?
A No. I really do not remember.
Q Did you know about the existence of JABS at this stage in February 1996?
A Yes, I am sure I did.
Q What did you understand it to be?
A I think my understanding was that it was a parent self-help group for individuals who felt that their children had been vaccine damaged.
Q Would you turn now to page 55? Following that outpatient appointment,
Professor Walker-Smith writes to Dr Shantha. There is a reference about three or four lines down to the mother having been told by social services that it was likely that MMR might have caused the problem and we have just looked at the note in relation to that on page 10. Professor Walker-Smith’s letter goes on:
“ … had been in touch with the organisation JABS who had mentioned the research that Dr Andy Wakefield has done at this hospital into the role MMR vaccination and Crohn's disease, hence my interest.”
As of April 1996, can you help the Panel with this, please? To what extent had you done research into the role of MMR vaccination and Crohn's disease by this stage?
A I think there is a minor confusion here. The work that I had done historically in relation to Crohn's was with natural wild measles and with the single measles vaccine. I had not at this stage made any association between the MMR vaccine and Crohn's disease, but I think that is just a minor misunderstanding.
Q He goes on:
“We have now seen a number of children who have had features of both Crohn's disease and autistic behaviour following MMR. Whether this is causally related I simply don’t know at present. [Mrs 3] is keen that we pursue this avenue. In the first instance I have screened [Child 3] with routine blood tests et cetera and we will consider in due course whether it is appropriate to go ahead and perform a colonoscopy.”
Just pausing there for a moment, frequently there is the use in correspondence as we go through this to the word “we”. When it is used like that – we will obviously have to ask the author of the letter – what would be your reaction to the use of that word “we”?
A I think it is a matter of style and I tend to use that expression very much so, because I work in a collaborative environment; it is not one person, but a group with the collective intelligence and thinking of that group, and Professor Walker-Smith was working in very much the same way. I think that he uses that term to reflect the broad perception and approach of his group and indeed later my own.
Q As regards the performance of a colonoscopy, were you in fact to have any role in deciding whether to do one?
Q Was it correct that a number of children who had features of both Crohn's disease and autism following behaviour had been seen by that stage?
A 4 April. Just bear with me.
Q You can look at the chronology of referrals. Child 2 had been referred, Child 2 had been seen for a first appointment, Child 3 had been referred, Child 3 had had the first appointment. That is according to The Lancet 12 at any rate.
A Yes. What this I think does not take into account also is that Professor Walker-Smith had on his unit around that time to my memory a child with inflammatory bowel disease and Asperger’s syndrome, part of the autistic continuum. So I only knew peripherally about that child, but clearly his experience of this was greater than mine.
Q Can we look at page 54, please? This is a letter written on the same date as the letter to Dr Shantha. Professor Walker-Smith writes directly to yourself. He sets out a short history in paragraph 1 and in paragraph 2 he says:
“ … I have told the mother that we would like to consider colonoscopy within the next one or two months and she has agreed. I have not yet booked for a colonoscopy until we have got the full details of the investigative protocol worked out.”
Can you help us as to how you interpreted and understood those observations by Professor Walker-Smith when you received that letter?
A Certainly. Up to this point there had been detailed discussions about what should and should not be included in the clinical and, from my perspective, research aspects of the protocol that would be used to investigate these children and this is a reflection of Professor Walker-Smith’s diligence in deferring investigation of this child until in particular, I would imagine, his aspects, the clinical aspects of this protocol, were finalised.
Q On the same date, again he wrote three letters. The third one was to Dr Rosenbloom. That is at page 53:
“This child was referred to me by his GP because of the work of my colleague Dr Andy Wakefield at this hospital concerning the role of MMR in the genesis of Crohn's disease and more recently possibly in relation ship to the association with autistic behaviour.”
I just pause there. Is there any observation you want to make about
Professor Walker-Smith’s description of the work of yourself at the hospital as he described it to Dr Rosenbloom?
A No, other than the minor caveat about MMR and Crohn's rather than wild measles or the single measles vaccine.
Q The point you made earlier?
Q I notice that the letter was in fact copied to yourself.
Q We need to pause there. Can you take the local hospital records, please, and turn to page 182? This is Dr Rosenbloom’s response to the letter of 4 April. I just turn it up for reference purposes. The letter I want your help with is at page 180, where
Professor Walker-Smith writes for the second time to Dr Rosenbloom on 16 May:
“Thank you so much for enclosing [Child 3’s] notes … I am actually passing on your letter to my colleague Dr Andy Wakefield who is the inspiration of our work linking MMR, autistic behaviour and Crohn's disease and I am asking him to write to you to fill you in on our proposed study.”
That letter was not copied to you, but did you come to see this letter at any stage?
A It no doubt will have been part of the clinical record and therefore available to me during the compilation of The Lancet paper.
Q There are two aspects of that letter which your colleague, Professor Walker-Smith, wrote. You are described as “the inspiration of our work linking MMR, autistic behaviour and Crohn's disease”. In respect of that, could you help the Panel, please, sparing your blushes, as to what were you inspiring in relation to, on the one hand, your work and, on the other hand, Professor Walker-Smith’s work?
A I imagine what Professor Walker-Smith is referring to here is my synthesis with the help of my colleagues, including Professor Walker-Smith and his team, of a unifying concept of how a viral exposure, in this case, as a measles containing vaccine, might be involved in the cause of not only a bowel disease, but possibly also of a neurological disease as well.
Q What about the reference to the proposed study? What study in fact was proposed as of May 1996?
A What we were proposing jointly was a clinical and scientific investigation that was from Professor Walker-Smith’s team’s perspective an investigation of the child clinically and from my perspective the investigation of the child’s biopsies in the laboratory setting, research. That is covered under the term “study”. I should perhaps say very briefly in mitigation of Professor Walker-Smith’s perception of Crohn's disease, it was the case – and he will speak to this as well, I am sure – that in the first several cases that we had seen, the thinking was that this may be Crohn's disease and so that may be an explanation for his reference to MMR, autism and Crohn's disease.
Q You can put the local records to one side, please. If we go back to the Royal Free notes to look at the second outpatient appointment and if you go to page 11, you will see that took place on 17 July 1996. Did you have any role to play in that appointment?
Q In the penultimate line of page 11, again what I take to be Professor Walker-Smith’s writing, “Arrange admission for colonoscopy”. Did you play any part in that decision?
Q Can you turn on in the bundle to a sequence of four letters, all dated 18 July 1996, beginning at page 52? We can see in the top left-hand corner of page 52 a reference to the out patient clinic the day before. Professor Walker-Smith writes:
“Initial [blood] screening tests for [Child 3] for inflammatory bowel disease were negative. However we are arranging for [him] to be admitted on … 8th September for colonoscopy followed by a period of investigation …”
Then on page 51, we see a letter written to the school doctor, a reference again to the C-reactive protein being in the normal range and:
“ … we are pursing further the relationship between bowel inflammation and autism …”
Pausing there for a moment, was it your understanding that Professor Walker-Smith’s team was pursing the relationship between bowel inflammation and autism?
A Yes. Autism being part of the autistic spectrum and therefore under the same umbrella as the developmental disorders that we were seeing in these children. Yes, that had been the intention and the reason for putting together the clinical and scientific investigation.
Q In the third of these letters at page 50, Professor Walker-Smith writes to Dr Rosenbloom, thanking him for sending the notes and:
“… the initial blood screens for bowel inflammation were negative, however Dr Wakefield is of the opinion that subtle changes in relation to inflammation may be present in such children, and we have arranged [Child 3’s] admission for a week to 10 days for a period of intensive investigation.”
Dr Wakefield, help the Panel about that, please. Did you have a view that subtle changes in relation to inflammation may be present in such children?
A Yes. Bear with me one second. (After a pause) Yes, I did. This is not my letter and Professor Walker-Smith will clearly be in a much better position to explain it than I am, but, as the Panel have heard, the presence of abnormal markers of inflammation in the blood can be helpful in predicting whether inflammatory bowel disease is present, but their absence most certainly does not mean it is not present, particularly in a subtle form, and it was my belief that there may be some subtle form of inflammation in the intestine. So to that extent Professor Walker-Smith’s position is correct.
Q To what extent, can you help the Panel, expressing that view may have influenced Professor Walker-Smith’s clinical management from your standpoint at the time?
A I do not think that anything that I could add to it could influence the opinion of someone with Professor Walker-Smith’s extraordinary experience. It is unparalleled and I have no experience of paediatric gastroenterology in a clinical context, so the way in which this child manifested, with intractable constipation, laxative dependent constipation, was, I imagine – and Professor Walker-Smith will speak to this – more than enough of an indication from his perspective to investigate this child. I do not think, and I think he may agree, that I was influential in any way in investigating this child.
Q The last of the four letters, page 49, is in fact written to you:
“This child with autism has had no evidence of bowel inflammation on routine blood tests, however we are arranging his admission for colonoscopy on Sunday 8th September, followed by your intensive investigations. I would [be] very grateful if you could arrange the other aspects of his admission.”
Again, two points. First of all, the reference on the face of the document to “your intensive investigations.” Is there any comment you want to make about that?
A There are two possibilities: one, that he is referring to the laboratory investigations that I might be undertaking on any biopsies that were procured, and the alternative is that it is a typo. The reason that I say that is I think later, in a similar letter about Child 12, he refers to “our investigations.” So, there are two possibilities. Again, it is not my letter and Professor Walker-Smith will be in a better position to speak to it.
Q Could I ask you this: Did you in fact have any intensive investigations?
A Not of a clinical sort. Our work might be considered by some in a laboratory to be intensive, but I would not have described it as such.
Q Secondly, the reference to:
“I would be very grateful if you could arrange the other aspects of his admission.”
What did you take that to mean when he wrote to you?
A Again, two possibilities, none of which are mutually exclusive. One is that I was in a position to deal with biopsies for research purposes when they became available. The other possibility is that I had agreed in an administrative role to inform Dr Harvey and Dr Berelowitz, via their secretaries, that this child might be coming to the ward, so that they could make time in their schedule to see the child. So he may well have been referring to that particular administrative aspect.
Q When you received this letter did you read that as referring to the arrangement of clinical investigations?
A No, I did not.
Q On page 45 there is another letter from Dr Casson, this time to the mother, on 28 August 1996. Was this copied to you, Dr Wakefield?
A It does not appear so and I do not remember it.
Q The letter says:
“This letter is to confirm that [Child 3] is to be admitted … on 8th September 1996 for colonoscopy.
Any further investigations required will be decided on another occasion following consultation with Dr Wakefield.”
Were there to be any investigations to be decided upon by you at any later date?
A Certainly no clinical investigations at all. That was not my role. Whether Dr Casson is referring to research is another matter.
Q On 9 September Child 3 was admitted. If you go to page 12 there are a series of investigations which are carried out, and could I take this in the same structure as before. Who decided whether or not these investigations should take place?
A Professor Walker-Smith.
Q Did you have any role to play in the decision making?
A No, I did not.
Q What was your view at that time as to whether or not these investigations were clinically justified?
A It was my opinion that they were clinically justified.
Q More specifically, the Panel will be astute to have in mind head of charge 13(e). Did you have any role to play specifically in the performance of a lumbar puncture?
A No, I did not.
Q The EEGs which were carried out, you can find references to those at pages 81 and 80. Those two can be taken together. Looking at page 81, is there any writing on that form which is yours?
Q The evoked responses you can find at page 78 and 79, the report at page 79. If you look at page 78 is any of that writing yours?
Q Following the admission there is an entry I would like you to look at, please, at page 24 of the notes, for 25 April 1997. You are here writing to Professor Walker-Smith:
“I spoke to [Mrs 3] yesterday. I am sure that he is one that should be included in the treatment protocol, since his biopsy showed clear evidence of colitis. He is currently on liquid paraffin but may well benefit from sulphasalazine.”
The first question arises in relation to contact with Mrs 3. Did you have contact with her?
A Yes. She will have called me.
Q Was that in any way unusual?
A No, I had an ongoing relationship with many of these parents, who would call me and tell me how their child was doing and I was always interested to hear.
Q When you said to Professor Walker-Smith that you were sure that he was one that should be included in the treatment protocol, what were you referring to there?
A Based upon the observations of inflammation in the first two children who had been investigated, and in particular the beneficial response of those children, both in terms of their gastrointestinal symptoms and apparently also their behavioural symptoms, there was clearly the emerging indication for treatment of children with this bowel problem with standard medication that one might use in, say, Crohn’s disease or ulcerative colitis. The mother had called me and said that her child was still suffering very much from his prior gastrointestinal symptoms. At that stage I was scrutinising the records for the purposes of assimilating the information and noted that he had inflammation and that he was not on treatment, so I made that information known to Professor Walker-Smith in addition to the fact that his mother had contacted me indicating that his bowel symptoms were continuing.
Q What would you say to any suggestion that you were overstepping the limits of your appointment?
A I was not putting myself in the position of taking any executive decision in this child’s care. That is clearly my understanding of what I was and was not allowed to do. What I was doing, and as Professor Booth alluded to, I was making a suggestion. It was entirely up to Professor Walker-Smith whether he acted upon that suggestion or not. I was not prescribing and I was not taking any executive role in this child’s management.
Q What would you say to any suggestion that you had no business even making this suggestion since you had no paediatric qualifications?
A Bowel inflammation is bowel inflammation irrespective of whether it occurs in adults or children and I have extensive experience of dealing with inflammatory bowel disease per se, whether in adults or not. In addition, we had seen clinical benefit in those children who had already been through this programme. Not to have brought these matters to Professor Walker-Smith’s attention – the mother’s concern about her child’s continuing symptoms, the fact that the child had demonstrable inflammation that had not as yet been put on treatment – it was my duty to bring those issues, those matters, to
Professor Walker-Smith’s attention, and I made a suggestion, but I made absolutely no executive decisions in the management of this child.
Q Would you turn on to page 23? Professor Walker-Smith writes to the GP five days later and we can see what it says. Is there any comment you want to make about that?
A Professor Walker-Smith has considered this and in fact has taken a decision to treat this child, not with sulphasalazine but with a more modern fibre aminosalicylate preparation, an anti-inflammatory medication, and there it is.
Q Did you play any role in that decision making which we see exemplified on page 23?
A No, other than bring it to Professor Walker-Smith’s attention I had no role in this.
Q There are a number of entries in the notes which post-date the publication of
The Lancet but for completeness I would like you to deal with them.
THE CHAIRMAN: A message is coming through to me whether it is possible that we could have a short break at some stage.
MR COONAN: I had lost track of time.
THE CHAIRMAN: Hopefully sooner rather than later.
MR COONAN: I can do it straight away.
THE CHAIRMAN: Thank you, I think that is very helpful. We will now break. It is quarter past eleven, so we will resume at 11.35, and once again, Dr Wakefield, please do not discuss your evidence. We will now break.
(The Panel adjourned for a short time)
THE CHAIRMAN: Yes, Mr Coonan.
MR COONAN: Dr Wakefield, what I would like to do is to look at a number of documents which postdate The Lancet publication but I want to include them in the global view of your involvement in these children. The first reference we can find, please, is at page 21 of the Royal Free notes when, on 30 March 1998, you write to Professor Walker-Smith about Child 3.
“[Child 3] is having continuing problems to the extent that he is now being taken into residential care in view of aggressive behaviour in association with his autism. The child psychiatrist, Dr Walsh to whom I spoke today on the phone, believes that he has Tourette’s syndrome and may benefit from medical intervention with, for example, Holoperidol or Prozac.”
You go on to say:
“One of [Child 3]’s continuing gastrointestinal problems is severe constipation, and I think this may well be contributing in a large way to his symptoms and signs. They have asked if there is local paediatric gastroenterologist who could manage, on a day-to-day basis, the problem with his chronic constipation, and I said that I would write to you to endorse this recommendation. I am sure they would be very grateful for your advice.”
There are two or three issues that I would like you to address from that letter. The first is that as of March 1998, were you still in contact with the parents or particularly the mother?
A I do not believe so, no.
Q How did it come about that you spoke to Dr Walsh?
A I received a telephone call from Dr Walsh in error, in fact. It would more appropriately have gone through to the department of paediatric gastroenterology.
Q Did you talk to Dr Walsh?
A Yes, I did.
Q We will look from his standpoint of matters in a minute, but in the second paragraph you in effect say to Professor Walker-Smith that “they” – I am just wondering who are the “they” there – “… they would be very grateful for your advice.” In writing that as you did, what role were you adopting?
A I was acting as a conduit for Dr Walsh’s concerns and thoughts to
Professor Walker-Smith. Dr Walsh had wondered if I, or we, knew of a local paediatric gastroenterologist who might be in a position to manage this child’s care on a day to day basis. I was unable to answer that, so I offered to pass this information on to Professor Walker-Smith so that he was able to give an opinion.
Q Would you turn to page 20. About two weeks later, Professor Walker-Smith writes to the GP.
“I understand that [Child 3] is having a deterioration in his general behaviour.”
Then he wonders if it might be helpful to substitute the Sulphasalzine elixir for a therapeutic trial of Pentasa. Any comment to make about that in the light of your letter on page 21?
A It seems that by reference to my description to Professor Walker-Smith in the first paragraph of the fact that this child had been taken into residential care on the basis of his aggressive behaviour, Professor Walker-Smith may have felt that a change in treatment was necessary. I should explain that one of the observations that we made over time was that aggression in children with autism, children who were unable to communicate, non-verbal children, pain often manifested as aggression, outburst of aggression – either against themselves, self-injurious behaviour, or against others. The observation was made in a clinical setting that treatment with anti-inflammatories which led to improvement in their gastrointestinal symptoms also lessened their aggressive behaviour. That may be the basis for Professor Walker-Smith’s recommendation in this instance.
Q We can ask Professor Walker-Smith about that basis, but for my purposes I want to ask you this. Did you take any part in the decision which we see illustrated on page 20?
Q I am going back to page 21. In acting as you did, first of all in having a conversation with Dr Walsh and, secondly, in writing the letter to Professor Walker-Smith, what would you say to any suggestion made that you were stepping outside the bounds of your employment?
A I did not step outsides those bounds in any way. I was acting as a conduit for Dr Walsh’s thoughts and questions to Professor Walker-Smith to enable
Professor Walker-Smith to take an executive decision in this matter.
Q I would like to turn to Dr Walsh’s view of things. You can find that, please, at the GP notes, page 89. The date of this document can be found at page 94, bottom left-hand corner, 1 April 1998. There are two passages I would like your comment about in this report by Dr Janet Walsh. On page 91 under “Past Medical History”:
“[Child 3] has had a history of bowel problems since the age of 17 months. Dr Wakefield at the Royal Free …”
Do you have the reference there?
A Sorry. Could you give me the first, please.
Q Page 91, half-way down the page.
A I have it, yes.
Q If I am going too fast, please say.
“[Child 3] has had a history of bowel problems since the age of 17 months. Dr Wakefield at the Royal Free performed in-patient investigations in 1995 and diagnosed Non Specific Colitis.”
Just pause there. As a statement of fact, is that correct or incorrect?
A No, it is incorrect in many aspects.
Q Did you have anything to do with inpatient investigations in 1995?
Q Did you diagnose non-specific colitis?
Q The second sentence:
“He believes that [Child 3’s] autism and bowel problems are both related to the MMR vaccine.”
Would you like to comment on that?
A I believe there is a possibility that they may be related, but these are Dr Walsh’s words, not mine.
Q Then on page 94 under paragraph 4 “Irregular Bowel Habit”:
“I have discussed this issue with Dr Wakefield, Consultant Gastroenterologist at the Royal Free Hospital.”
Pausing there, was that a correct description of your title?
A No. It carries with it the connotation that I was a clinical gastroenterologist which I was not, and I had never suggested to Dr Walsh that I was.
“He agrees that [Child 3’s] bowel condition, (Non Specific Colitis), should be monitored locally and believes that [Child 3’s] bouts of constipation may well be exacerbating his behaviour problems. The prescribing of Salazopyrin and Ferrous Sulphate also need to be reviewed. He will be writing to [Child 3’s] GP to request a local referral.”
Can you take that in constituent parts, Dr Wakefield, and help the Panel as to the accuracy or otherwise of some of Dr Walsh’s assertions?
A Yes. I will try to provide some interpretation. Dr Walsh asked me if I knew of a local paediatric gastroenterologist because she felt his condition, as I have referred to earlier, should be monitored locally. I will undoubtedly have said, “That sounds like a good idea,” and to that extent, I agreed with her that local monitoring would be in the child’s best interest. Again, as I have mentioned to you and to the Panel, there was a growing impression that behaviour such as aggression might be related to abdominal pain in particular, and I will have mentioned this to her. The issue of Salazopyrin and Ferrous Sulphate finds no mention in my letter to Professor Walker-Smith and this may be something that she felt she needed to review. It clearly it was not my place to write to Child 3’s general practitioner, nor did I at any stage, and this information was passed on to Professor Walker-Smith for his executive decision.
Q We have looked at a letter from Professor Walker-Smith on 14 April, at nearly two weeks later on page 20?
Q Further on still in the chronology, if you go to page 74, this is now in 2001, in July, and it is a letter from a Dr Roberts, who is an associate specialist in community paediatrics, to Dr Shantha, the GP. I just want to ask you, please, about the accuracy or otherwise of one passage in this letter. The second paragraph:
“[Child 3] is a young man with Autism. He was previously under review by Dr Wakefield…”.
“… and [Mrs 3] has been told that Child 3’s autism is MMR-related.”
Had you by this stage told the mother that Child 3’s autism was MMR-related?
A No. That is something that she told us. My belief is that it was possible MMR-related.
“[Child 3] has also been diagnosed as having a ‘leaky gut’ and was placed on Sulphasalazine by Dr Wakefield in 1996.”
A I do not think the diagnosis of leaky gut was made in this child at all.
Q What about the placing on Sulphasalazine by you?
A I did not place any child on any treatment.
Q And finally you go back two pages, please, to page 72. It is a letter from Dr Rosenbloom. Again, this is in November 2001. I am looking at the first paragraph of any bulk on page 72. It is a letter written to Dr Casson.
“His mother was convinced that this was secondary to MMR immunisation and subsequently found her way to the Royal Free Hospital where it is my understanding that Andrew Wakefield on endoscopy found evidence of what he considers to be inflammatory bowel disease …”.
Pausing there, were you involved in any way with the carrying out of an endoscopy?
Q Did you see the result of the endoscopy?
A I will have seen images taken at the time or the histology that resulted from that, but I was in no other way involved.
Q It goes on:
“… and has treated [Child 3] since then with Salazopyrin and Sytron.”
Again, did you ever treat Child 3?
Q Dr Wakefield, that is all the clinical entries I am going to ask you about in terms of the investigation and subsequent treatment, bar a couple. I want now just to follow in broad terms the layout of the outstanding head of charge, which is charge 13. You just need to follow it in broad terms. Head of charge 13(a) and 13(b) has the backdrop. It is the same template approach that I adopted with the other two children. Which, if any, of the investigations carried out on Child 3 were research investigations in your opinion?
A The analysis of biopsies taken during the procedure of colonoscopy.
Q Are any of the other investigations to be counted as research in your opinion?
Q In respect of those elements which you say are properly to be considered as research, would you have needed ethical committee approval?
Q Did you have ethical committee approval?
Q Which was that?
Q In the light of your analysis of this, was a start date relevant to any aspect of this case?
Q And I have there in mind head of charge 13(c)(i). Was the existence or application of entry or inclusion criteria relevant to this case?
Q And in particular the existence of a diagnosis of disintegrative disorder and the existence or pre-existence of a vaccine, was that a requirement?
Q I have in mind there, for the assistance of the Panel, head of charge 13(c)(ii) and 13(c)(iii). As to consent forms, head of charge 13(d), in respect of the investigations which you have considered to be clinical in nature and purpose – you have given evidence about that – would you expect there to be consent forms for those?
A Yes, I would.
Q If you look at page 122 of the Royal Free notes, what is the status of that document?
A This is a Royal Free Hampstead NHS Trust consent form for the clinical investigation, in this case, by colonoscopy.
Q Would you expect there to be a consent form for the research biopsies that you have described, for which you needed ethical committee approval?
A Yes, I would.
Q If you look at page 120, what is the status of that document?
A This is a consent form for research biopsies pursuant of EPC approval 162-95.
Q Would you expect there to be a consent form for matters other than the two categories that you have described?
Q On the Legal Aid front, can you help the Panel as to whether you had any knowledge one way or the other as to the Legal Aid position of this child?
A No, I did not. Certainly not until some time after. Indeed, I am not certain when and if he had Legal Aid.
Q So far as The Lancet is concerned, what materials would you have had when you were engaged, as we will hear about later, in the drafting of that paper?
A Once again, I would have had the entire clinical records, contemporaneous with the preparation of The Lancet paper. Clearly not those documents that arrived afterwards. In addition, his mother would have been asked to provide at some early point evidence of his Red Book, his developmental records from early infancy.
Q For the purposes of The Lancet, did you have any input from either Dr Anthony or Dr Dhillon?
A Yes, in exactly the same way as we did with other children, Dr Dhillon and Dr Anthony, but Dr Dhillon in particular provided a systematic scoring of his intestinal biopsies for the purpose of providing an in-depth detailed analysis.
Q Again, to keep the Panel abreast of the documentation, take volume 7, please, and turn to tab 19. You have given evidence about the nature of this document principally in relation to Child 2, but just help us about the status and purpose of it, would you?
A This is a pro forma method of collecting information in a systematic way, largely for the purpose of making sure that all relevant information on this child is ascertained.
Q Was that available to you either in one form or another at the time of The Lancet paper?
A The information was. I am not certain when these documents were first put together. That was my job, but quite when, dating it, I cannot be precise, I am afraid.
Q I omitted, if I can rectify this now, to ask you this question in relation to Child 1. If you look at tab 23, please, do you have any comment to make about that now?
A This is exactly the same pro forma document on Child 1 in draft form.
Q That is all I seek to ask you about that child. You will now need for Child 4 both the Royal Free and the GP notes. Dr Wakefield, can we start, please, by looking first of all, just to get our bearings and then we will go back, at the referral letter in the Royal Free bundle, page 27. I am just going to turn this up to set the scene, so if you want to refresh your memory for a moment, just cast your eye over it, because we will be going swiftly to look at another document and then come back to this one. Could you now look in the GP records at page 125? You will have noticed that the referral letter is dated 1 July 1996 and this letter is dated 12 June. It is a letter from yourself to the father of Child 4:
“Thank you very much for your letter regarding your son. I would be very grateful if you could phone me or my secretary with your telephone number so that we can discuss this directly. It is much easier to answer many of the questions in this way. I look forward to hearing from you.”
Forget for the moment all the other bits of writing on the page. The reference on the first line, where you thank him for his letter regarding his son, that letter from the father to you is not in the bundle. Can you remember what it was that was in the letter?
A No, I cannot remember precisely, but it will have been his description of his child’s condition, his symptoms and how he came, or how his father believes he came to be in that position.
Q Did you subsequently speak to either the father or the mother?
A Yes. I think that in accordance with the suggestion in my letter, the mother subsequently called me.
Q Why did you invite the father in this letter to telephone so that you could discuss the questions raised?
A Clearly the father or the parents jointly had raised a number of questions. I cannot remember what those were now, but I felt these could be dealt with over the telephone.
Q Can you remember any advice you gave to the mother?
A I think once again, in light of what she perceived to be her son’s chronic gastrointestinal problems, she was seeking help, seeking referral, and I will have given her exactly the same advice as I gave all parents: that the proper procedure was to get their doctor to seek a referral to Professor Walker-Smith.
Q How would you describe your role in first of all sending the letter and, secondly, having the telephone conversation with the mother?
A My response to her was out of politeness and concern, because they had raised a number of questions with me. In light of what she was able to tell me on the phone and in light of her request, then I acted as a conduit by which she might get help from Professor Walker-Smith, if her doctor felt that that was appropriate.
Q Following receipt by the family of this letter, just so the Panel can follow it – I do not think this is controversial – we heard from Dr Tapsfield that the letter was brought into his surgery by the mother and he told the Panel that he then had a telephone conversation with you. Do you accept that?
Q It was following that telephone conversation that he annotated at least part of that document at page 125 that we see.
Q When the telephone conversation took place between you and Dr Tapsfield, what role were you performing then?
A What I had indicated to this parent and indeed all parents was that I would be very happy to discuss this with their doctor in an entirely generic sense. In other words, not necessarily discussing the individual child in question, other than to say, “The parent has called me and described these symptoms. This is the background to our thinking at the Royal Free, if this helps in any way in the decision-making process.” Clearly we were dealing, as you have seen from the protocol, with a complex situation: multiple symptoms in children, a possible link between the bowel and the brain – this is not necessarily intuitive to anyone – and therefore I offered by way of information, which I felt was essential, if there was any confusion, to provide the background information. So what I said to parents is, “I would be happy either for your doctor to call me or for me to speak with your doctor. Would you let them know that I will call and I will discuss this background information with them.” That is what I did on a number of occasions.
Q Again, it perhaps is timely to ask you this question even at this stage. Was it in any way inappropriate for you to discuss these matters generically with the general practitioner?
A Not at all. This was a discussion between colleagues of a complex situation and my job, or at least my role as I saw it was to be in a position to provide background information to the doctors in this matter.
Q So far as your contact with the mother was concerned, either in the letter which we do not have or in the telephone call, can you help the Panel about any apparent motivation on the part of the mother? For example, was she concerned about any potential linkage between MMR and her child’s condition? Was she motivated by litigation? Can you help about those matters?
A I remember this child well. He was one of the sickest children that I have seen. Certainly I have now seen several thousand children with autism and he sticks out in one’s memory. Her concern was for the wellbeing of her child and the possibility that something might be done to help him. It was her conviction from the outset that the vaccine was in some way related to his clinical condition and I have no memory of discussing litigation with her.
Q Let us now look at the referral letter which followed the conversation between you and Dr Tapsfield. The referral letter is at page 27 of the Royal Free notes and is addressed to yourself. Do you have any comment to make about that?
A Yes. I do not intend any criticism of the general practitioners in this, but there is a recurring theme through the various letters that arise in the context of referral. Despite the information that is given, a number of mistakes are made. I can illustrate that by cross-reference to the annotated letter that the GP, Dr Tapsfield, held from the mother. I have indicated, as you will see, on page 125 of the GP notes that there is an annotation from Dr Tapsfield, “ECR, John Walker-Smith”. I have clearly told Dr Tapsfield that if he considered a clinical referral to be appropriate, then it should go to Professor Walker-Smith in the department of paediatric gastroenterology. Nonetheless, when he writes the letter some time later, the letter is sent to me. In this instance, I am correctly identified as the consultant in experimental gastroenterology, which is what I will have communicated to these doctors, indicating that I do not have a clinical role. Just to mention, because a number of these errors do arise through the course of the correspondence, in the end it was decided by Professor Walker-Smith and myself to send a detailed letter setting out the generic background, because then it would make it much easier for doctors, rather than having to refer to their annotations or their notes, to be able to consult that letter to get not only the background, but the mechanism of referral.
Q We will look at that letter at a later stage. Let us look at the body of this letter.
“Following our recent telephone conversation I would be grateful if you could arrange an appropriate ECR appointment for [Child 4] to undergo assessment regarding his possible autism and his bowel problems.”
He sets out some of the previous history and encloses a letter written to a Dr Wraith in Manchester. He says this in the fifth line in the second paragraph:
“I’m aware that you are looking at the possible links between measles vaccine and various difficulties and [Child 4] certainly had MMR in 1988.”
He sets out further features of the history and ends up at the bottom of the paragraph:
“The professionals who have known [Child ] since birth do not entirely agree with this however and there is a suggestion that some of [Child 4’s] problems may have started before vaccination.”
He sets out issues with his bowels and over the page further matters, parental observations about diet, and then in the last paragraph:
“I would be grateful if you could arrange an appropriate appointment and would be very interested if you feel [Child 4] fits into the sort of category of patient that you are interested in looking at further.”
Quite apart from the fact that, as you said, it should have been addressed to Professor Walker-Smith, when you got this letter what was your reaction to it?
A I thought it was a rather good referral letter and I had no argument with any of it. I was again struck by the penultimate paragraph where he referred to the fact that he has not gained weight and when we saw this child at the Royal Free he resembled something from a – a child from a famine zone of Africa. He was, as I say, one of the sickest children that I have seen with this condition.
Q Would you look now at the GP notes at page 123, just to continue the chronology. Dr Tapsfield writes to the mother:
“I’ve received further information from the Royal Free …”.
Just pausing there, do you accept that Dr Tapsfield and you had had a telephone call by this stage?
Q Continuing with the letter:
“… which suggests that [Child 4] falls into a group of patients that they are interested in looking at further. I’ve sent them a letter down asking to see him and I think they will be contacting you in due course with an appointment.”
Then if you go back to the Royal Free notes, page 26, on 4 July 1996 did you write to Professor Walker-Smith passing on the referral letter which we have just seen at page 27?
A Yes, indeed. I passed it on to him. This was the obvious thing to do in light of the fact that this should have gone to him directly.
Q You say in that letter on page 26:
“[Child 4] sounds like a good candidate for our forthcoming study.”
What did you intend to convey by that phraseology?
A By virtue of what the parents had told me and by virtue of the contents of Dr Tapsfield’s referral letter it was quite clear that this child would be just that, suitable for our forthcoming clinical and scientific investigation.
Q That was in July 1996 and unless I am wrong – and I shall be corrected – there does not appear to have been an out-patient appointment for this child. Did you have any role or part to play in any decision that there may have been – we will have to explore that – not to have an out-patient appointment?
Q Let us move on to 28 August on page 25. This is another one of the four Casson letters, a letter from Dr Casson to the parents.
“This letter is to confirm that [Child4] is to be admitted … on Sunday 15th September 1996, for colonoscopy. Any further investigations required will be decided on another occasion following consultation with Dr Wakefield.”
Two things: First of all, did you have any part or role to play in any decision to admit this child for colonoscopy?
Q As you understood it, were you to play any part or role in deciding what further investigations should be done?
A If by this Dr Casson means clinical investigations, absolutely not. If, alternatively, he is referring to analysis of biopsies in a laboratory setting, then the answer may be yes.
Q Was that letter ever copied to you?
A It does not appear so, no.
Q This child was admitted to the Royal Free on 29 September 1996. We can see that by reference to the Royal Free notes at page 5. Did you take any part in the clerking-in process of this child?
Q A series of investigations was carried out. Again, perhaps it may be helpful if I just summarise them: colonoscopy, lumbar puncture, MRI, EEG and evoked responses principally, for my purposes. As far as you understood it at the time, whose decision was it that these investigations should be carried out?
A Professor Walker-Smith.
Q Did you play any part in the decision-making process in respect of those investigations?
A No, I did not.
Q Again, particularly in the context of this case, what about the sequencing or the order in which investigations were carried out? Was that any part of your responsibility?
Q On page 10 we can see the plan written out in respect of those investigations and I think – I shall be corrected if I am wrong – that is Dr Casson’s writing. In relation to the lumbar puncture which was carried out on this child, were you in any way a cause of him having that procedure carried out?
Q What did you understand to be the purpose of the – and this is my phrase – basket of investigations which were carried out? I have just listed them. What did you understand the purpose to be?
A They sought to identify a possible organic basis for his symptoms.
Q What about their justification at the time? What was your state of mind about those?
A That they were entirely clinically justified.
Q Can I ask you then to move to one aspect of the EEGs? You will pick this up first of all, as I say, at page 10; you will see the plan there, EEGs and ERs, item 3 of the list. If you turn on to page 63 and 64, if you take those together, is the test number on both documents the same?
A It is.
Q Looking at page 63, is any of that writing yours?
Q Looking now at page 65 and 66, take those two together, is the test number the same on both?
A It is.
Q Looking at page 65, is any of that writing yours?
Q Move on to page 67 and 68. The first observation is if you look at page 67 at the test number at the top, does that test number appear on page 68?
Q Looking at page 67, first of all, I just want to look at the quality of the photocopying here. Previous forms of this nature, if you just turn back to page 65, you will see come out very well in the photocopy. The first box, which on page 65 is ticked, is a reference in type to “EEG.” Do you see that?
Q On the photocopy on page 67, certainly in my copy, it does not come out. I do not know about your copy. Can you see a reference to EEG there?
A No, I cannot. It has not come out.
Q Should we, in effect, therefore, write in “EEG” in respect of that box?
A Yes, I think we can safely assume that is what it means.
Q Looking at this document can I ask you, please, to look at the writing in respect of the top right-hand corner, the test number and the hospital number. Is that your writing?
Q Looking at the rest of that right-hand box – that is, the personal details – is that your writing?
A Yes, it is.
Q On the left-hand box, the writing opposite the “EEG” section, which is again poorly photocopied, can you tell the Panel whether that is or is not your writing?
A That is not my writing.
Q Looking at the “EP” box, which is ticked, is that your writing, both the surviving writing and the crossed-out writing?
A Yes, it is.
Q Looking at the crossed section, “Request Source”, etc., is that all your writing?
A It is.
Q What about the date? Is that in your writing?
Q The final box, the reason for request and the signature, is that in your writing?
Q What is the status of this document as completed by you?
A This is me acting in my agreed role as, in effect, a clerk arranging these tests, not ordering them, having no clinical executive decision making. That, you can see from the records, has already been taken, and I am merely arranging this test as previously agreed.
Q When would those tests have been previously agreed?
A I think you took us to the clerking-in record in the list.
Q By all means refer back but I think the reference is page 10.
A (After a pause) Correct.
Q Is that right?
Q I should just ask you, for the purposes of completeness, were you present or taking any active part in any ward round at which that plan was arrived at?
Q Can I get back, please, to page 67. You have written down that the request source is Dr Harvey. What is that intended to convey?
A Input into the clinical protocol was, as I have mentioned previously, sought from colleagues in their respective fields, in particular in Dr Harvey in the field of neurology and Dr Berelowitz in the field of child psychiatry and their recommendation was that these – or Dr Harvey’s recommendation in this particular instance was that this test merited inclusion and therefore his name is given as the referral source.
Q On this document what test were you arranging?
A This is an EEG and it looks from this document as though visual evoked response is a part of that request as well.
Q You have circled ECR. Again, there are a number of examples of this, but perhaps it is timely just to deal with it now. What did you intend to convey by circling that?
A For administrative purposes the Trust requires to know whether these are extra-contractual referrals or whether they are previously commissioned referrals through a contract with a particular health authority. Therefore they are able to invoice the particular responsible authority – in this case it was an extra-contractual referral.
Q The final box “Reason for request/relevant history/current medication” – why did you make the entry as you did in those terms?
A This was, as previously discussed, the working diagnosis, or among the differential diagnoses, according to the instruction that we had received from Dr Berelowitz and according to the gastrointestinal symptoms, that is disintegrative disorder and enteritis, and myelopathy is an abnormality of the myelin, the insulation of the nerves in the brain. It would be something that would lead to a conduction defect, detectable upon EEG or during evoked responses.
Q Did you intend to convey that there had in fact been a positive diagnosis of disintegrative disorder?
Q On page 68 there is a report. I just want to assume for the purposes of my following questions that this document does in fact refer to page 67 – all right?
Q On that assumption, we have Dr Sherratt, whose name has appeared previously, saying, in respect of the binocular flash, “Normal waveform. We do not have latency values from control subjects for this test.” Dr Wakefield, it may be at the moment that you are not able to answer this, because we will be looking at many other examples as we go through this. As matters stand, do you accept as a matter of fact that the department did not have latency values?
A I do not know. I do not accept it because my reports had not mentioned it. Indeed, it seems somewhat perplexing to me that a clinical department offering a clinical test would allow that test to be undertaken if it could not be interpreted in the light of what they considered to be normal values. It seems bizarre. Moreover, for my own instruction, I had gone to the various departments such as radiology and, in this case, electrophysiology, to try and understand from the head of department what the merits of these investigations might be, or what information might be gained from them. As I say, purely for my own instruction. This was one of those tests that was under consideration, having been recommended by my clinical colleagues. There was a perfect opportunity for the head of department to say, “I would not recommend this because we do not have control values.” He did not say that, and so the tests, according to the instructions of the clinicians, were undertaken. I remain a little confused.
Q I shall come back to this, so for the assistance of the Panel it is head of charge 15(h). I shall come back to this question, Dr Wakefield, at the end of the eleven children that were the subject of The Lancet paper at the end. All right?
Q I am going to leave head of charge 15(h) pending for the minute. Dr Wakefield, there is one matter that is not, as I understand it, the subject of charge, but for completeness could I deal with it. Would you turn to the last page in the Royal Free notes. The subject matter is “Photography” and this occurs in a couple of these cases – I think occurred in relation to one of the cases this morning as well. I want to deal with this generally, if I may. What is in fact going on here is that at the bottom of the photocopied page you have here a signature. Is that yours?
Q There is a “Consent to Photography” by the parent.
“I understand that the photographs which I have agreed to may be useful for the purpose of teaching & research.”
Q What were you about when you took a consent from the parent for photography?
A Photography is often used in clinical medicine, as the Panel members may be aware, for documenting physical signs. These may be documented for research purposes or for teaching purposes, both of which were part of my role at the Royal Free. As I mentioned, Child 3 exhibited a severe degree of wasting, failure to thrive. He exhibited a feature characteristic of some children with autism, particularly those with bowel disease, and that is toe-walking. Quite what the association between toe-walking and the gastrointestinal problem is we do not know, but nonetheless, there it was. So for the purposes principally of teaching, and being able to communicate these physical signs to others by way of lectures, for example, I asked the mother if I might obtain a photograph of photographs of her son, and she was in agreement.
Q I think just in the course of your answer you referred to Child 3. I think you are now referring to Child 4. In so far as we see other examples of the photography, does your answer apply similarly to those situations?
A Yes, it does.
Q There are two short sections on the notes, please. If you look in the GP notes, page 10, beginning at the bottom of page 9. There is a note in the GP’s records for, I think, 21 November 1996. For current purposes, I am going to ask you please, Dr Wakefield, to assume that that is a correct date. We see that the GP has noted a telephone call with you.
“Discussed Dr Wakefield re GI abnormalities. ? new syndrome ? related to susceptibility to abnormal reaction to MMR → [leading to] modified inflammatory bowel disease → neural lesion → autism. No idea of treatment yet.”
That is Dr Tapsfield’s entry. Do you accept you had a conversation with Dr Tapsfield?
Q And what was the nature of that contact?
A Again, as with all other GPs with whom I had contact, it was by way of providing a generic background which Dr Tapsfield has captured in annotated form here, by what we at the Royal Free collectively thought might be going on in these children, particularly in terms of the relationship between a possible link between a vaccine exposure, a bowel disease and a neurological problem.
Q Were you at any stage during this telephone conversation purporting to be dressed in the clothing of a clinician?
A Not at all.
Q Would you go back to the Royal Free notes, page 19. Part of a report that you can see begins on page 14. The question arises on page 19, but the introduction is on page 14. This is a letter and report by Dr Colver in October 1998 to Professor Walker-Smith. On that page, page 14, he says:
“I enclose a copy of my provisional report.
I originally sent it to Dr Wakefield and he kindly made a fully reply which was helpful to me.
However, he pointed out that the clinical care that [Child 4] has received at the Royal Free has been under your care and I should therefore be grateful for your thoughts.”
Does Dr Colver get it right in that sentence?
A Yes, he does.
Q On page 19, which is in the report as opposed to the letter, half way down, under the heading of 2Details of services needed, follow-up arranged, monitoring or support offered”::
“[Child 4] needs and receives follow-up by Dr Wakefield in London.”
Was that correct or not?
A That was incorrect.
Q Therefore can I turn finally to the approach of the charges. The Panel will be having in mind head of charge 15 – 15(a) and 15(b), please, as a background. What research elements do you say were taking place in relation to Child 4?
A This was research on any biopsies obtained at colonoscopy within my laboratory.
Q And with laboratory work on those biopsies?
Q What about the investigations which you have described as “clinical” – were those part of a research study as you understood it?
Q So far as the extra biopsies and laboratory work consequent upon those, would you require EC approval for them?
Q And did you have it?
Q And what was it?
Q In relation to the investigations which were carried out on this child, was the concept of a start date relevant?
Q Head of charge 15(c)(i). So far as entry criteria or inclusion criteria, head of charge 15(c)(ii), was that a relevant conclusion concept?
Q Consent forms, head of charge 15(d), in relation to the investigations which you have characterised as clinical, would you expect there to be consent forms?
Q Would you turn to page 80 of the Royal Free notes. Is that what you would expect to see in relation to clinical investigations?
Q In respect of the biopsies which you have described as “research driven”, would you expect there to be consent forms for those?
Q Research consents?
A Yes, indeed.
Q If you look at page 79, what do you say about that document?
A This is a consent form for research biopsies pursuant to 162-95.
Q Two final matters, first of all in relation to Legal Aid. Did you have any knowledge one way or the other about the existence of a Legal Aid certificate for this child?
A No at this time, no.
Q So far as The Lancet drafting is concerned, what material would have been available to you when you were engaged in the drafting of The Lancet?
A As with the other children, the full clinical record, contemporaneous clinical record and, I believe, the early developmental record.
Q Would there have been the equivalent of a pro forma at that time?
A There would have been a draft pro forma, yes, at some stage.
Q As I have already said, I shall come back and deal with head of charge 15(h) at a later stage. That completes the questions for Dr Wakefield in relation to this child.
THE CHAIRMAN: I think this is a very appropriate time for everybody to have a lunch break. It is now one o’clock and we will resume at two o’clock. Dr Wakefield, again, you are still under oath and still in the middle of giving evidence.
(In the absence of the witness)
MR COONAN: Can I just mention one housekeeping matter. I am very conscious that this is, again, quite dense material and I am entirely in your hands as to how much you want to hear. I am more than happy to run on for as long as the Panel wish to, but may I invite you to consider the point over the luncheon adjournment.
Obviously it is Dr Wakefield’s opportunity to give evidence about these matters. It would be our wish, naturally, that the Panel were able to give it the fullest attention and analysis as the evidence emerges.
THE CHAIRMAN: In fact we have been talking about it. I actually do think that. This is also my own personal feeling as well – I think by four o’clock I do feel we really have heard enough for a day. The evidence, from our point of view, just does not finish here when we leave the room. Actually the whole thing keeps on going on in the mind in different ways, and we keep reflecting on it all the time.
The second issue that has to be in consideration is actually Dr Wakefield. He has been giving evidence for a few days and it seems that he will continue to give evidence for a further few days. I think it is also important that he is still able to concentrate in continuing to give the evidence.
Keeping all those things in mind – and I am looking at my Panel members again – I do feel that four o’clock is probably the appropriate time to call stumps for the day.
MR COONAN: I was conscious of that last night, but I felt it appropriate to try and complete Child 2 last night, rather than going on till this morning. With that caveat I, for my part, could not agree more. I think four o’clock is a decent time.
THE CHAIRMAN: I do take that into account. Sometimes, of course, you are at a stage when you feel that you may need to go over for a few minutes or, at some time, you might find that a few minutes before is a more appropriate time to conclude for the day. Do feel free to do that, with those caveats – as long as we keep the target of four o’clock in mind, particularly during this stage of the hearing.
MR COONAN: Thank you very much. That is very helpful, sir.
THE CHAIRMAN: As we have run over 1 o’clock, I suggest we come back at five past two.
THE CHAIRMAN: Good afternoon, everyone. Mr Coonan?
MR COONAN: Sir, could I turn to Child 5 and may I invite you, Dr Wakefield, to take the GP records and the Royal Free records, please? May we start by looking at the GP records, first of all, the referral letter, which you will find at page 105. The GP – in fact, there were two; this GP is Dr Shillam; the other GP is Dr Letham. This is a letter from Dr Shillam to Professor Walker-Smith dated 1 October 1996. I am not going to read it all out, just highlight a couple of parts of it:
“This 7¾ year old autistic child’s parents have been in contact with Dr Wakefield and have asked me to refer him to yourself regarding your current study into association between autism and childhood bowel problems.”
In the second paragraph he sets out a series of features of the history, which you will note as we go through it. Then at the bottom of the page:
“His parents are concerned about an association they have read in the ‘Daily Mail’ between MMR vaccine, childhood enteritis, and possible brain damage.”
The first point I seek your help on is this. If you look at the first line, was it correct that the parents had been in contact with you?
A Yes. Specifically the father.
Q How did it come about that the father made contact with you?
A As alluded to at the bottom, he had read an article in The Daily Mail. This had made reference to some work of mine and my group and he had followed it up by tracking me down at the Royal Free and I believe he wrote or contacted me by telephone.
Q What did the father have to tell you?
A Again, as with the other parents, he described a boy who had developed normally and who, shortly after his MMR vaccine, specifically I remember him saying he had developed a change in his voice, a growly voice, and had progressively lost skills, socialisation and eye contact. In association with this, or at least at the same time, he had developed gastrointestinal problems.
Q In terms of what the father had to tell you, is what appears in the second paragraph on page 105, is that description consistent with what the father had to tell you?
A Yes, I think it is.
Q What did the father want?
A He was seeking access to clinical care, someone who might help him with his child’s clinical condition.
Q What advice, if any, did you give him?
A As with the other parents, I suggested that if his general practitioner were agreeable, then a referral to Professor Walker-Smith might be appropriate.
Q How would you describe your role in relation to that contact with the father?
A Again, as with the other children, my role was merely as a signpost to Professor Walker-Smith.
Q Did you have any contact with the GP practice at about this time?
A Yes, I did. As I mentioned before, I had said to the father, “In view of the complexity of this, I would be very happy to describe the generic background to our work to your doctor if it would help. He can either contact me or I will contact him, if you will let him know.”
Q If you turn to page 106, we see a note made by Dr Letham in relation to a telephone conversation which you had with him. Do you accept that you had a telephone conversation with him?
Q How did it come about first of all that you telephoned the practice?
A I believe the father asked me if I would do that on his behalf.
Q Who did you intend to speak to?
A I had intended to speak to Dr Shillam, I think it was, but I got Dr Letham instead.
Q He described to us how he made this note. Can we just go through it and then I will seek your observations on one or two aspects. Child 5’s name is noted at the top and the date of the note and the telephone call, 30 September, the day before the letter of referral.
Q The note reads:
“Dr Wakefield consultant gastroenterologist Royal Free rang & gave a v. lengthy and convincing …”
which he has underlined twice –
“ … case for [Child 5] to be referred to … ”
And Professor Walker-Smith’s details are set out. Obviously these are his words and his subjective assessment. What is your assessment of what you said to him in terms of length and as to the nature of any case that you were putting in relation to referral to Professor Walker-Smith?
A I was not able to, nor would I have done, make a case for any child in particular. I did not know this child, for example, but I would say and did say, “This is what the father has reported to me and what I am calling you to do is to provide you with some background on our thinking about what may be going on.” He seems to have found that case, that generic background, compelling and he goes on to record that below in some detail and accurately.
Q Let us look at it. He goes on after the details:
“As they have findings suggesting that there is an association between inflammatory bowel disease/enteritis causing a failure to absorb B12 which is needed to myelinate till age 10 [leading to] neurological problems/autism.”
Do you have any comments so far?
A I think that, among the various notes from general practitioners, captures it reasonably well.
Q It goes on:
“(Measles vaccine may …”
Underlined I think four times –
“ … be implicated but that is being researched & uncertain of implications.)”
Can you help us about your input to him which led him to make that note?
A Yes. I think it accurately captures what was our relatively cautious perception at that stage, that there may be an association, and that was one of the factors that we were trying to rule in or rule out.
Q The reference to “research” there?
A That was specifically in relation to the work for which I was responsible, that is, the laboratory work.
Q The last three lines:
“Anyway – see fax – parents are keen. Will you refer – presumably is extra contractual.”
We have not been shown a fax. Do you know anything about a fax?
Q Were the parents keen for a referral? Do you know?
A Yes, they were. That was one of the motivating factors in the father contacting me in the first place.
Q In relation to your role in speaking to Dr Letham, how would you describe that?
A It was, as I have mentioned before, by way of providing a generic background and understanding to the doctor of what it was we were thinking at the Royal Free and I hoped that it was useful to the doctors concerned.
Q Was this in any way, if I can put this four-square to you, an attempt to persuade the GP to refer this child?
A No, not at all. I left it entirely to his discretion. He knew the patient, or his partner knew the patient, Child 5, well and he was able within the context of what I had told him about the generic background to determine whether it applied to his patient and therefore whether to make a referral.
Q Given the nature of your role in speaking to this GP and indeed others, what do you say about the observation which has been passed that it was unusual for there to be a contact of this nature?
A I think we were dealing with an unusual situation, unusually complex, and which had clearly been through the hands of many doctors who had not, at least until this stage, been able to shed a great deal of light on what was wrong with these children. The mechanism of referral, that is, the GP seeking a referral to Professor Walker-Smith, after that referral had been initiated by the patient, it is entirely reasonable and routine. Increasingly it is the case that parents or patients seek out particular doctors for particular procedures and this was no different. My job, or my role, which I saw as being entirely reasonable, was, if it was necessary, to provide some background information. I do not see that communication between colleagues, particularly in a complex situation like this, in the best interests of the child is anything but consistent with good medical practice.
Q Did you in any way ask or request Dr Letham to refer or indeed ask Dr Letham to ask Dr Shillam to refer?
A No, I did not.
Q Did you have any contact with Dr Shillam at all?
Q For completeness, if you just go back to page 105, there is a reference in the second line to “your current study into association between autism and childhood bowel problems.” Again – and I appreciate I have asked this question in other contexts, but it is important that I dot the “i”s and cross the “t”s as far as is reasonable – what study was in fact current at that time?
A At that time, there was a clinical programme, clinical protocol, in action, which was designed to define the organic basis, or attempt to define the organic basis for these children’s symptoms and in addition there was an adjunct research programme under my control, which was to analyse biopsies taken from these children during the course of their routine clinical procedures.
Q Professor Walker-Smith having received that letter of referral at page 105, responded to Dr Shillam at page 104 on 4 October 1996:
“I would be delighted to see [Child 5] and I have arranged for an outpatient appointment to be sent.”
Was that decision anything to do with you?
Q If you put that volume to one side and now turn, please, to the Royal Free notes and look at page 40. This would appear to refer to the outpatient appointment on
8 November 1996 and we can see that at the top it has Dr Murch’s stamp, with another stamp of the paediatric food allergy clinic. Leaving aside the first three lines of that, do you recognise the body of the handwriting on that page and the next page?
A Yes. It is that of Professor Walker-Smith.
Q Did you have any role in that outpatient appointment?
Q We can see what the result of that outpatient appointment was if you turn back to the GP records at page 93. This is a letter written by Professor Walker-Smith to the GP, Dr Shillam, dated 12 November 1996 with a reference to the outpatient clinic appointment on 8 November 1996:
“Many thanks for referring this child with autism and disturbed behaviour. He demonstrated how difficult his behaviour can be when I saw him in the clinic and we did not proceed with any blood tests. He has a number of episodes which have been interpreted as abdominal pain when he draws up his legs and appears to suffer from abdominal pain. He has intermittent episodes of diarrhoea … Several of these children with autism have had gastrointestinal symptoms and on investigations have proved to have gastrointestinal pathology. I am arranging for him to come in for a colonoscopy on Sunday 1st December 1996.”
That letter was copied to you. Did you have any role to play or part to play in the decision to admit him for colonoscopy as set out in that letter?
Q If we just now go back to the Royal Free notes and pick it up at page 38, the date at the top of this is noted to be the 10th, but it may be from other sources that that is an error and it should be the 1st, but no matter whether it is the 1st or the 10th. Quite apart from your familiarity with Professor Walker-Smith’s writing, do you recognise that writing?
Q In relation to the clerking of this admission, did you have any role to play?
Q The documents within the body of the clinical records demonstrate a number of investigations which were carried out. Did you have any input into any decision, first of all, to carry out a colonoscopy?
Q Did you have any input into any decision to carry out a lumbar puncture?
Q Specifically, did you cause him to undergo a lumbar puncture?
Q So far as the order in which investigations were done, was that a matter for you in any way, or for others?
A For the clinicians.
Q So far as those investigations were concerned, did you have a view at the time as to whether or not they were clinically justified?
A It was my view that the were clinically justified.
Q There is a particular letter I want you to comment on. Would you turn on, please, to page 354 in the Royal Free notes? This is dated 4 December 1996, a letter from
Dr Berelowitz addressed to you.
Thank you for asking me to see [Child 5]. I saw his mother and observed [him] briefly on the 3rd December 1996.”
Then he sets out details of the history and in the last paragraph he says:
“I think the likely diagnosis is a developmental disorder, such as autism. However, I though he was a slightly unusual looking child and so obviously the usual chromosomal studies need to be done.”
Did you have any contact with Dr Berelowitz before he saw this child?
A No. As I have mentioned, according to the prior arrangement when it was determined that this child was coming in I notified Dr Berelowitz’s secretary that this child would be on the ward in the following week so that he might make time to see the child. The formal clinical referral always came from the clinicians and Dr Berelowitz, I think, early in the course of seeing these children, made this mistake on a number of occasions but later on you will find these letters disappear.
Q There are some request forms which are in the bundle. The first one is at page 453. There are two to look at, beginning at page 453. There are reports at page 454 and there is another request form at page 455. Let us just take them step by step. On page 453 you will see the test number in the right-hand corner, F4124. If you turn the page you see that number in respect of the report towards the bottom part of the page.
A Yes, I do.
Q Let us go back to page 453. If we look at the EEG box, which is ticked with a date and a time, is that your writing?
A No. The tick may well be mine, but the writing is not.
Q The rest of the writing on the form in relation to the EP box, the request source and the reasons, are they in your writing?
A They are.
Q Let us take the “Reason” box first. Did you intend to convey that there had been a positive diagnosis of disintegrative disorder?
Q What was the sense in which that note was made? To convey what?
A It was a provisional diagnosis, but when I had originally gone to the department to speak with the department head I said, “These children, when the order as given for this test to be performed, I’ll include the term ‘disintegrative disorder and enteritis’ or words to that effect, in that box”, so that the department is aware of the source from which they are coming.
Q If we look now at the request source you have written in the name “Harvey” and the name, after a forward slash, “Wakefield.” Why does your name appear there?
A It is a very good question. It does not appear on any other form and was an aberration in completing this form. The request and the ordering of the test came from the clinicians and I was acting in a clerking role to arrange that test as before, but I cannot provide an explanation for that.
Q In terms of the clinicians, would Dr Harvey have been an appropriate clinician to order the test?
A Yes. Dr Harvey was in large part the influence behind including the EEG and evoked potentials in the clinical protocol.
Q If we turn now to page 455 we see a document which has the same test number. The EEG box is also ticked. Is the writing on that form yours, any of it?
Q The entries, apart from the failure to circle the ECR box, appear to be identical, apart from the absence of a date and the writing alongside the EP box. Dr Wakefield, I am not going to ask you to attribute what was in the mind of anybody else who wrote this document, but can you shed any light on the system which may have been operating at that time?
A Yes. I do not quite understand why there should be a replication of the form or the request form in the records. It does not quite make sense, unless within the department – and there seems to be a consistency in the handwriting in these replicate forms. I just wonder whether this is someone from within the department, the electrophysiology department, filling the form in using the form that, for example, I have completed as a template, for the reporting of other elements of the test. Other than that I cannot explain it.
Q It would appear that the lumbar puncture was carried out on a re-admission, certainly on my reading of the notes, and insofar as that is correct did you have any input at all to the decision to carry out the lumbar puncture on the second admission?
Q After this child was admitted there was a series of correspondence which I am going to ask you to look at and we can start this by looking at the GP records at page 79. This is Professor Walker-Smith writing to the GP, Dr Shillam, on 7 March 1997, as I have said, after the admission.
“I was pleased to see [Child 5] again in the clinic”,
and he sets out his observations on the gastrointestinal issue. Similarly, in terms of the basis for medication in the second paragraph, and I just pick it up at the penultimate line of that paragraph:
“I have therefore changed the medication to Pentasa 500 mg twice a day …”,
and again, did you have any role to play in the medication regime applied to this child?
Q In the third paragraph:
“I have not made an appointment to see this child again in the outpatients and will leave it to you and the parents to decide how long he needs to go on Mesalazine for the moment.”
Then in the final paragraph he says this:
“In relation to the research that is being done concerning this group of children I suggest that you or [Mrs 5] should be directly in touch with Dr Andy Wakefield who is directing the research aspect of this study.”
Can you comment on that assertion made by Professor Walker-Smith?
A It is entirely correct and consistent with what the Panel are now aware of. What we have here is a detailed clinical letter, typical of the way in which one would deal with a clinical management of a child like this and then at the end a reference to the fact that I am in charge of the research aspects of this particular investigation.
Q If you just turn back a page to page 78 you will see Dr Shillam’s response, to follow through the correspondence. On 10 April 1997 Dr Shillam says to Professor Walker-Smith:
“His mother would be very grateful if he can have a follow-up appointment with your clinic in the next three months or so …
I note on your recent letter [which we have just looked at] that you suggest [Child 5’s] parents should be in touch with Dr A Wakefield. Would it be possible to arrange that contact via your secretary?”
Then on page 77 Professor Walker-Smith replies to Dr Shillam:
“Many thanks for your letter”,
and we just looked at that:
“I would be delighted to see [Child 5] and I have arranged for an outpatient appointment to be sent. [Mrs 5] can telephone Dr Wakefield’s office to make an appointment.”
Again, just to tie up that end, Dr Wakefield, on what basis would you, in your office, be concerned to make appointments?
A I did not make formal appointments as such but if a parent wanted to make contact with me to find out the results of a research test, for example, then I would be very happy for that to take place.
Q There is a particular document which you can find in a letter which begins at page 73 and continues at page 74, and the issue I am going to ask you to deal with concerns your role, actual or perceived. Dr Brostoff writes to Dr Shillam in June 1997, responding by saying:
“It was very kind of you to refer [Child 5] to me and also to send a copy of Dr Richer’s letter.”
The summary of the background here I am not concerned with for current purposes, but I want to take you to page 74, please, beginning at the paragraph half-way down:
“The recent admission of [Child 5] to the Royal Free Hospital under Dr Wakefield has shown yet another facet which is also being investigated in the USA”,
and then he deals with the clinical features of the current situation. Dr Brostoff, in asserting that he was admitted under Dr Wakefield, is he correct or incorrect about that?
A He is incorrect.
Q In the next paragraph he says this:
“I mention all these threads in the investigation of autistic children and if you agree, I will send a copy of this letter to Dr Wakefield so that we can coordinate the therapy. My view would be that Nystatin is generally useful in these children and is unlikely to conflict with Pentasa. I will, however, ask Dr Wakefield for his opinion.”
Dr Wakefield, that is at the bottom of the page, a letter which was copied to you. Do you accept that?
Q What followed is to be found in the Royal Free notes at page 319. You will have noted when we looked at page 74 that Dr Brostoff’s letter had not been copied to Professor Walker-Smith. Right?
Q We now look at this letter, dated 12 June 1997, from Professor Walker-Smith to Dr Brostoff.
“Your letter to Dr Wakefield was sent on to me. I am the clinician involved, Andy Wakefield is overall directing the research. I enclose a copy of [Child 5’s] discharge summary”,
and he goes on to deal with the medication regime. What do you say about Professor Walker-Smith’s response to the Brostoff letter?
A It is entirely accurate and consistent with the clear theme that he is responsible for clinical care and I am responsible for the research programme.
Q In the same bundle, the Royal Free bundle, would you go now to page 34. On
17 July 1998, again post The Lancet publication, we see what appears to be two stamps, one headed “Food Allergy Clinic” and the next one “Wakefield Clinic”. Leaving aside the numerals next to the weight, height and age, do you recognise the writing which appears immediately below that?
A That is Professor Walker-Smith’s writing.
Q Did you have a clinic on 17 July 1998?
A No. I have never had a clinic.
Q We now move to page 282 in the same bundle. This is now much later in 1998, and there is a letter from Dr Furlano, a fellow in paediatric gastroenterology, to whom I take to be the then GP, Dr Hiorns. The body of the letter deals, as we can see, with medication. The middle of the document refers to medication, as we can see. At the end of the letter, Dr Furlano says:
“We will review [Child 5] in six months time together with Dr Andy Wakefield.”
That letter is apparently copied to you. Can you help about that comment? Were you to have any role in reviewing this child, whether in six months or at all?
A No. Once again, I sat in as an observer in that clinic, and this time Dr Furlano, a junior paediatric gastroenterologist, was taking the clinic, and my role was as before, merely as an observer.
Q Did you in fact sit in later on? Can you remember?
A I cannot remember.
Q The final piece of material which I would like your opinion on is at page 368. This is, I think, an undated immunology request form. Is that right?
Q And, just in summary, what does it tell us was being requested?
A It looks as though it has gone to the attention of Dr Peter Amlot, who was an academic immunologist in the department of immunology, who ran a particular assay, looking at an aspect of immune system activation. This is part of the clinical service. It appears to be a request for that test.
Q In the right-hand side of the document, the consultant box appears to have the initial “JWS”, but there is a box underneath it, where it says “For further clinical information contact:” and then the doctor’s name, and somebody has filled in your name. Can you tell the Panel, is any of the writing on that form yours?
A No, it is not.
Q Can you help the Panel about this. Would you yourself have put yourself forward as a person who would be best placed to obtain clinical information from?
A No. I would not be the best person to obtain clinical information.
Q Who would?
A One of the clinicians.
Q There may be a number of reasons why this has happened but can I ask you this question. Do you know why your name has been put there?
A I cannot remember. I have no idea, I am afraid.
Q The charges that relate to Child 5, the live ones, relate to head of charge 21. I am going to follow the same template as before. During the time that this child was referred and investigated and indeed treated, what research was being carried out?
A Research was being carried out on biopsies taken during his routine clinical colonoscopy.
Q The clinical investigations that you have just described, were any of those properly described as research?
Q In relation to the research biopsies that you described, would you have needed ethical committee approval?
Q And did you have it?
Q And what was it?
A It was 162-95.
Q Was the existence and application of a start date relevant to the referral investigations and management of this child from your standpoint?
Q That is head of charge 21(c)(i).
Q Were entry criteria relevant?
Q Head of charge 21(c)(ii) and 21(c)(iii). So far as consent forms are concerned, that is head of charge 21(d), in relation to the investigations that you have described and identified as clinical in nature, would you expect there to be consent forms?
Q Would you look at page 457, what is the status of that document from your standpoint?
A This is a Royal Free Hampstead NHS Trust consent form for clinical investigation, in this case a diagnostic colonoscopy.
Q In relation to the research biopsies which you described as having a research purpose, would you expect there to be consent forms for those?
Q Look at page 458. Is that what you would expect?
Q Would you expect any other research consent forms in this case?
Q Legal Aid: did you, during the course of the referral and investigation, know anything at all about this child’s Legal Aid position?
A No. This child did not have Legal Aid during that time.
Q Did you subsequently become aware that he had a Legal Aid certificate?
A Yes, I did. In fact this child went on to become one of the lead cases in the MMR litigation.
Q When would you have become aware of the fact that he had a Legal Aid certificate?
A I would imagine probably relatively soon after it was awarded, though I do not know the precise date of that.
Q And so, again so there is no mystery about it, are you saying that he was one of the Legal Aid Board 5?
Q Finally this: in relation to the compilation or I should say your role in the compilation of The Lancet paper, what material did you have available to you when you were engaged in that exercise?
A As with the other children, I had his full contemporaneous clinical record and, I believe, his early developmental record.
Q Again it is a question I ask in relation to all these children: would you have had all the histological reports and results and so forth?
Q All the documents we see in the body of the notes?
Q Would there have been a pro forma, at least a draft of the pro forma, containing the distillation of the information that you had explained before?
A At some stage, yes.
MR COONAN: That is all I ask about that child, sir. You might find it convenient to have a short break.
THE CHAIRMAN: Yes, indeed, and we will now adjourn. It is just about five past three, so we will resume at twenty-five past three.
(The Panel adjourned for a short time)
THE CHAIRMAN: Mr Coonan?
MR COONAN: Thank you. We are going to look at Child 6. You will need, certainly this afternoon, the GP notes and the Additional Record bundle. There are other references in the main bundle and possibly in the Royal Free, but I hazard a guess we may not get to that this afternoon. I am going to start with the GP records.
Dr Wakefield, do you have the GP records?
Q If you turn to page 125, you see that on 9 August 1996 Dr N writes a letter to you.
“Dear Dr Wakefield
Re: [Child 6] …
Following our discussion over the ‘phone the other day Child 6 is a little boy with autism syndrome who does also suffer from bowel disorder. His mother is interested in entering him into your trial and I would be grateful if you could see her for discussion.”
First of all, do you accept that you had a telephone discussion with Dr N over the telephone before this letter was sent to you?
Q Before we come to the content of that discussion, I would like to ask you, please, whether prior to that you had had any contact with the mother?
A Yes. Mrs 6 had called me.
Q When was it, do you think, prior to 9 August that she made contact with you?
A I would think it was in the recent past.
Q Can you remember now?
A No, I cannot.
Q I do not want this to be a memory test, but it may be that you might be assisted by looking at a note at page 29 in the GP notes. There is a note here in the GP notes for 25 March 1996. I think, unless I am wrong about this – I will be corrected if I am as a matter of fact – this was a note made by the GP in respect of the discussion with the mother.
“Dr Wakefield Royal Free. To discuss [association] measles and autism and inflammatory bowel disease.
Discussed general concerns re family.
If we feel relevant can refer to [investigation] to Prof Walker at Royal Free.”
That appears to have been in March. Do you think you may have had a discussion with Mrs 6 prior to that, or at about that time?
Q When you had that discussion with Mrs 6, what did she tell you?
A Mrs 6 had two affected children, both Child 6 and Child 7 as the Panel are now aware. Her story was very similar to that of other parents of a normally developing child – 6 – who shortly after receipt of his MMR vaccine underwent developmental regression, ultimately diagnosed as autism, associated with the onset at the same time of chronic gastrointestinal symptoms.
Q Are there any other details she told you?
A Undoubtedly there were. I think loss of continence was another manifestation of his clinical decline, but without the note or pro forma in front of me, I do not remember.
Q If it becomes necessary, then you can have such assistance as is appropriate. For my purposes, that will do. When she told you these things, what did she appear to be wanting?
A She wanted clinical care for her child, Child 6.
Q What advice, if any, did you give her?
A As with the other parents, I said that what would be appropriate, if she considered it right, would be for her general practitioner to make a referral to Professor John Walker-Smith. I think the note that is made here on page 29 captures that conversation rather well, “if we feel relevant”. In other words, the executive decision-making process is deferred clearly to Dr N, as was the case with other doctors.
Q Following your discussion with the mother, she has a discussion with Dr N and Dr N has a discussion with you on the telephone, as the letter at page 125 makes clear.
Q Let us look at the nature of the discussion between yourself and Dr N. What was that all about?
A Again, this would have followed an identical format to my discussion with other doctors. I would have said that this mother had been in contact with me, had described the following symptoms in her child and, “by way of information, this is what we are thinking and doing at the Royal Free. If you feel that this is appropriate for this child, then you may wish to consider making a referral to Professor Walker-Smith.”
Q As with the other contacts which you had had, how would you describe the role which you had when you had contact first of all with the mother and then subsequently with Dr N?
A To the mother, I was merely a signpost for the mechanism by which she might get help for her child. To the doctor, I was the source of generic information which might help him in his decision making process.
Q That was on 9 August. I now want to move on, please, to the following month. For this, you will have to look in the additional records at page 2. On 4 September you write to Professor Walker-Smith and say:
I received this letter … ”
Pausing there, is that the letter from Dr N which we have just been looking at?
“I received this letter from a GP who has a child with autism and bowel disorder who may be suitable for our study and who I am sure would be appropriate to be seen by you in outpatients.”
First of all, was it appropriate that you should send the letter from the GP that you had received to Professor Walker-Smith?
A Yes. This is another of those instances – and again, this is not in any way a criticism – in the initial doctor’s note from his conversation with the mother, there is reference to Professor Walker; “Smith” is missing. In my telephone conversation with him, I will have reiterated that the referral should go to Professor Walker-Smith in the department of paediatric gastroenterology and it is unfortunately sent to me in the department of paediatrics. So the errors are repeated and I took this letter and clearly passed it on to Professor Walker-Smith, as was appropriate.
Q As you say, there is no criticism of that. You send it to Professor Walker-Smith. In that letter on page 2 of the additional records, you also say that this child may be suitable for “our study”. What did you intend to convey when you used that expression?
A That is correct. The GP’s letter which should have gone to Professor Walker-Smith describes the developmental problem and the gastrointestinal symptoms and therefore he is seeking a clinical referral for investigation and this would be part of our clinical and research study.
Q You go on to say:
“… who, I am sure, would be appropriate to be seen by you in outpatients.”
Was the question of whether in fact it was appropriate for the child to be seen in outpatients a matter for you or for Professor Walker-Smith?
A It was entirely a matter for Professor Walker-Smith or a matter for the GP and Professor Walker-Smith to resolve.
Q On the next page, a week later, Professor Walker-Smith writes to Dr N. I am just going to assume for present purposes that Professor Walker-Smith has actually seen the referral letter. It is not necessarily clear from this, but we can ask him. What the letter says, as written to Dr N, is this:
“I have been asked by Dr Wakefield to see [Child 6] … ”
I just pause there for a moment. Had you in fact asked him to see Child 6?
A In effect, notwithstanding the confusion of Dr N’s letter to me, it was in fact Dr N who was asking for an expert clinical opinion from the Royal Free.
Q The terms of your invitation to Professor Walker-Smith, are they set out on page 2?
Q Let us go back to page 3.
“I have been asked by Dr Wakefield to see [Child 6] as I am the Paediatric Gastroenterologist associated with Dr Wakefield in … ”
And I am putting this in quotes –
“ … ‘our study on autism and bowel disorder’. I have taken the liberty therefore of sending Mr and Mrs 6 an appointment for [Child 6] …”
What about the words I have just put in quotes, “our study on autism and bowel disorder”?
A That is absolutely correct and it refers to his clinical investigation of this issue and my research investigation of this issue.
Q Insofar as Professor Walker-Smith took the decision of sending an appointment for Child 6, did you have any role to play in that?
Q At page 4 – this answers the question I posed to myself earlier – it would appear that Professor Walker-Smith did see that letter, does it not?
Q So we move on to page 5. This is the third letter of the same date:
“Dear [Mr and Mrs 6]
I understand from Dr Wakefield that you are interested in our study of autism and bowel disorder.”
Again, the same phraseology. Is that accurately put to the parents by Professor Walker-Smith in your opinion?
Q We can move on to page 38 in the additional records. I think lest there be any confusion, pages 38 and 47 are to be read together. Certainly that is how I have been treating it. If not, we will be told. Would that appear to make sense to you?
Q In relation to the outpatient appointment on 2 October, therefore in relation to page 38 and 47, leaving out the middles pages for the minute, did you have any role to play in that appointment?
Q Following that appointment, I would like you to look, please, at the first page of the additional records, taking this chronologically. On 4 October 1995, if you look at page 1, we have been told there is a typographical error in the date and that should read 4 October 1996. That would certainly make sense, would it not?
A I am sorry, which page?
Q Page 1.
A That is correct, yes.
Q It is from Professor Walker-Smith to you:
I was very interested to see [Child 6] in the clinic. This is a child who has been diagnosed as Asperger’s syndrome …”,
and he sets out a history which had been distilled and one can check that against the notes. I take you down, please, to the bottom of the letter:
“On examination his nutrition is good but he is clearly quite a disturbed boy. He fits well into the spectrum of children we need to investigate. I have arranged for him to be admitted on Sunday 27th October 1996.”
Would you like to comment upon Professor Walker-Smith’s phraseology of this child fitting well into the spectrum of children needed to be investigated?
A Yes. Given the clear association of developmental regression, gastrointestinal problem, this is a child who would be firstly and foremost suitable for clinical investigation, Professor Walker-Smith’s team as part of the equation and for research on the biopsies taken during any procedure as my part of the equation.
Q The last sentence on that page, and I read it again:
“I have arranged for him to be admitted on Sunday 27th October 1996.”
Did you have any part to play in the decision that this child be admitted for investigation?
Q Can you just remember the date please, Dr Wakefield, 4 October 1996, as corrected? You will now have to go back to the GP notes, and in fact this also appears in the additional notes, but no matter. Looking at the GP notes, page 123, it is the same date as the letter we have just been looking at which Professor Walker-Smith wrote to you. He is now writing to the GP. The first few lines are self-evident:
“I am arranging for him to come in to have a colonoscopy and entering our programme of investigation of children with autistic problems.”
Again, the reference to a programme of investigation of children, does that sit well or unwell with your analysis of the situation that you have been giving and providing to the Panel?
A Yes, absolutely. I think the Panel can take the word “programme” or “study” to be interchangeable in this context and this refers to Professor Walker-Smith’s clinical investigation and my research investigation.
Q You appreciate there are quite a number – I have not added them all up – of different expressions and I needed to have your view about each expression.
MR COONAN: Then we come to the admission to the Royal Free Hospital on 27 October 1996. Sir, I see that it is shortly before 4 o’clock and certainly as far as I am concerned it would be a convenient moment. I am not going to finish Child 6 by 4 o’clock.
THE CHAIRMAN: I think if this is a convenient moment for you then it is probably convenient for all of us to adjourn at this stage, and I am sure Dr Wakefield will also find it quite helpful. We will now adjourn and resume at 9.30 tomorrow morning. Dr Wakefield, you are still under oath and still giving evidence.
THE WITNESS: Yes.
(The Panel adjourned until 9.30 a.m. on Wednesday, 2 April 2008)