Tuesday, January 31, 2012

Day 7 GMC Fitness to Practice hearing for Andrew Wakefield



Tuesday 24 July 2007

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)


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 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.


Page No


Cross-examined by MR COONAN 1
Cross-examined by MR MILLER 6
Cross-examined by MR HOPKINS 11
Questioned by THE PANEL 12


Examined by MS SMITH 14
Cross-examined by MR COONAN 26
Cross-examined by MR HOPKINS 31
Questioned by THE PANEL 33

THE CHAIRMAN: Good morning, everyone. Mr Thomas, you had completed your examination-in-chief with Dr Tapsfield.

MR THOMAS: Yes, I have.

THE CHAIRMAN: We were about to start with the cross-examination but can I make one small housekeeping announcement for today. I know we are sitting for only half a day this morning. My understanding is we are going to complete this witness and have one more witness for today. One of the Panellists has got her appointment with the health care professional early in the afternoon. If possible she has asked me to say if we could finish nearer to 12.30 pm rather than 1.00 pm it would be helpful. Again, I do not want anyone to be put in a position of disadvantage. If the witness is in the middle of examination then it has to be finished.

Cross-examined by MR COONAN

MR COONAN: Can we revisit some of the steps that you described yesterday. Can you take the GP records for this child, Child 4. If you start at page 125 I am going to run through this chronology with you for a particular purpose which will be apparent later. Bear with me as we go through it even though you touched on it yesterday. At page 125 we see a letter from Dr Wakefield to the parent of Child 4, actually addressed to the father but for my purposes
I am not concerned with any difference between father and mother here.
A In fact, I do not think the father was involved at this stage and the name on that is fairly similar to the mother’s name. I wonder if that was a typographical error and it was addressed to the mother.

Q Absolutely. I take no issue about that. That could well be the case. At any rate, the letter is written to the parent by Dr Wakefield. If we look together at this document it is apparent, is it not, that Dr Wakefield has received a letter in relation to Child 4 from the mother?
A Yes.

Q That letter to Dr Wakefield, which we have not seen, is a letter which raised clearly many questions as we can see from the third line?
A Yes.

Q We have a situation where the mother is raising many questions of Dr Wakefield.
A Yes.

Q She then brings in that letter to you.
A Yes.

Q You and she discuss it and at some stage you telephone Dr Wakefield.
A Yes.

Q We know, do we not, because, if you look at page 123, when you are writing to the mother you say, on the first line,

“I have received further information from the Royal Free.”

A Yes.

Q There are not any documents that you have pointed to which may be said to have come from the Royal Free so therefore one assumes it was by word of mouth, by telephone?
A Yes.

Q If we needed further confirmation of that we can get it by looking at page 121.
A Yes.

Q If you look at the first line it is quite clear that you had a telephone call with Dr Wakefield.
A Correct.

Q You telephoned Dr Wakefield – the precise day does not matter for my purposes – at the mother’s request.
A Yes.

Q When you telephoned Dr Wakefield at her request, if we go back to page 125, it is likely, is it not, that you obtained from Dr Wakefield a reference to John Walker-Smith?
A Yes. I do not recall that but I would anticipate that annotation there may well have been following a telephone conversation.

Q It may be that you had this letter in front of you when you telephoned Dr Wakefield.
A I would think that would be quite likely.

Q In that telephone call you are obviously being given information by Dr Wakefield in relation to John Walker-Smith. Who did you understand John Walker-Smith to be?
A I have no recollection of that. I cannot recall the conversation.

Q That was really my next question. Can you remember now, 11 years later, what the nature of that conversation was with Dr Wakefield?
A No.

Q I think we can agree, can we not, that he is likely to have raised the question with you of an ECR?
A Yes.

Q In other words, that if a referral was going to be made out of region, or out of area, then at that time, in 1996, the question of an ECR would have to be addressed.
A Yes. As I said yesterday, the situation regarding referrals has been changing and is complicated. I cannot recall the exact details at the time but I presume that was the case at the time.

Q I do not want to go into the detail of this bureaucratic system at that time. As you say, it has changed. Referrals out of area had to face this question of whether or not there would be payment.
A Correct. The letter I wrote of referral, there was also a similar letter on the same date requesting an approval for an ECR.

Q Going back to this telephone call with Dr Wakefield, you can not remember the details - and I am not criticising you, it is 11 years ago - but at the very least you were given some information relating to John Walker-Smith. Did you know he was a Professor?
A I have no recollection.

Q Did you know he was a Professor of gastroenterology?
A I cannot recall any details.

Q At the very least I suspect we get some guidance from page 123 when, following this telephone call with Dr Wakefield, you write this letter to the mother which I suggest is something of a distillation of that phone call, which we see in the first two lines:

“I have received further information from the Royal Free which suggests that Child 4 falls into a group of patients that they are interested in looking at further.”

You must have got that from this phone call from Dr Wakefield.
A Yes, and that would have been my intention in making the phone call: to check that the referral was suitable and appropriate. I must have had enough information to enable me to decide that a referral was appropriate.

Q You have a responsibility to determine whether or not such a referral in those circumstances is justified and is reasonable.
A Yes.

Q And is in the interests of the patient.
A Yes.

Q You then wrote the referral letter which we see at page 121. You actually write the referral letter to Dr Wakefield.
A Yes.

Q Did you think he was a clinician at that time?
A Yes.

Q Having written the referral letter, I think the next documentary information that you received was on page 117 which is the discharge letter.
A Yes.

Q We know that it came from Dr Casson, on page 120, and having sent the referral letter off there is no other letter in between from anybody else.
A Not that I am aware of.

Q Having received the discharge summary from Dr Casson, did you look at the department from whence it came, at the top of page 117?
A Did I look at the time? I do not know if it registered or not. I have no recollection of that.

Q I just draw attention to it. Dr Wakefield’s name does not appear there in that department.
A Right, I doubt I registered that.

Q You receive this discharge summary and I think at that stage you then telephone Dr Wakefield, is that not right?
A I am a little bit unsure of the dates on which I made phone calls. I did suggest yesterday that perhaps there was an entry dated wrongly. I think on reflection it may be that phone call was actually dated correctly and did not refer to the original phone call to Dr Wakefield but referred to a later one, possibly after this admission. I cannot recall.

Q Dr Tapsfield, you clearly have thought about that overnight.
A Yes.

Q May I suggest that rethinking of it overnight is absolutely correct.
A I have not reviewed it since then but that was just a reflection.

Q If you look at page 9 we see that on the Lloyd George card there is an entry at the bottom of the page of the 21 November 1996, is that right?
A That is the one I am referring to.

Q Just so we get our bearings, that follows the discharge summary, does it not?
A If that date is correct, that would follow. I suspect that is correct, yes. That would follow the discharge summary.

Q If we follow the page over to page 10, the rest of the entry is set out. There is, on the last line of that entry on page 10 – I am not going through the whole of it – your note “No idea of treatment yet”.
A Correct.

Q Again, this was as a result of you telephoning Dr Wakefield.
A I suspect so, yes.

Q Following the discharge summary.
A Yes.

Q And you getting this summary from him, which you have noted, and you end up with that note there “No idea of treatment yet”.
A Yes.

Q So we can agree about that.
A Yes.

Q So it is obvious, is it not, that insofar as you have elided a discussion with Dr Wakefield and a reference to the question of treatment, there it is in that note.
A Yes.

Q Because yesterday you told the Panel that you suspected that you had discussed the question of treatment with Dr Wakefield on one or more than one occasion.
A Yes.

Q Now, I want to just explore that with you. Now, there is clearly a reference in this note on page 10 where the question of treatment is mentioned.
A Yes.

Q Because you phoned him, thinking that he was a clinician.
A Yes.

Q Following that telephone call, can I suggest to you that you did not speak to Dr Wakefield ever again?
A I cannot have any recollection of that. I may have spoken to him. As I say, the problem is when we were using paper records it was very difficult to always record telephone conversations because the records might not be available at the time, so obviously there were telephone calls and the records were not completed, which was not unnormal at the time.

Q Dr Tapsfield, the point, you see, is this: it may be that your evidence last evening may have given the Panel the impression there were occasions upon which you, apart from this phone call on 21 November that you had, as it were, discussed the question of treatment with Dr Wakefield, they may have gone away with that idea. All right?
A Yes.

Q Now, when you are giving evidence about these matters, you are giving evidence about matters eleven years down the line.
A Yes.

Q It would be unsafe, would it not, to speculate as to whether or not you did have a phone call with Dr Wakefield?
A Yes.

Q It may be that you telephoned about the question of treatment and spoke to somebody in the Department of Gastroenterology.
A Yes.

Q I am not disputing that. I am going to suggest to you positively that you did not speak to Dr Wakefield again after 21 November.
A I cannot comment, I cannot recall whether or not I spoke to him again after that date.

Q Well, now, I just want to see, again in the context of eleven years later, I have got in front of me a statement you made to Field Fisher Waterhouse, and do by all means if there is a clean copy available you can have a look at it. I do not know whether one is. For my purposes I shall just read out, unless you want to have the document in front of you – are you content if I read it, just to save time?
A Yes.

MS SMITH: Well, we are literally just getting it now.

MR COONAN: All right, if it is available, fine.

MS SMITH: We are giving him the original. (Same handed)

MR COONAN: Dr Tapsfield, can you just confirm that on the last page of this statement there appears your signature?
A Correct.

Q You will see that the statement was made on 5 November 2006, so that is about seven months ago.
A Yes.

Q Again, just to take you, if I may, please, to paragraph 25, and does paragraph 25 say this: “I have not been in contact with Dr Wakefield directly since the telephone call in November 1996”?
A Yes.

Q Was that your best recollection in November 2006?
A As I say, I have no recollection of any phone call, and there is no phone call referred to in the records, so yes.

Q So what I am about is this: when you were saying yesterday that you rather suspected you did have telephone calls with Dr Wakefield, that is going too far, is it not?
A Yes.

Q Now, if we just stand back for a moment, the referral itself, you have told the Panel, was firstly at the mother’s request?
A Yes.

Q But you are in a position of some importance because you are, if I can put it this way, the diagnostic gatekeeper, are you not, for referrals?
A Yes.

Q Although you cannot remember the precise discussion with Dr Wakefield, you were nonetheless sufficiently impressed by that discussion to have agreed to the referral?
A Yes.

MR COONAN: Yes. Thank you very much, Dr Tapsfield.

THE CHAIRMAN: Mr Miller. Mr Miller is representing Professor Walker-Smith.

Cross-examined by MR MILLER

Q Dr Tapsfield, Professor Walker-Smith came into the events with which we are concerned rather late, I think, with the letter that he wrote to you in March which contained recommendation of the treatment, but I would like to start at a slightly earlier stage if I may.
A Yes.

Q By the time we get to June 1996, there was a very long history of gastrointestinal problems going back to 1988, which are charted in the GP notes and the correspondence for this child.
A Yes.

Q A large number of referrals to various different specialists.
A Yes.

Q Considerable concern about the precise diagnosis of his behavioural developmental problems, but by June 1996 it appears that the working diagnosis was autism.
A Yes. Things have changed since then in the frequency with which one makes the diagnosis, and I think it was perhaps used rather more as a label than a diagnosis in 1996. Things have changed.

Q Precisely, because the phrase that you have used is that despite being seen by a multitude of clinicians (your words) there was no clear diagnosis reached for Child 4.
A Yes.

Q We have seen the efforts that you made to try to get referrals to places which might provide that answer.
A Yes.

Q To be fair, Mrs 4 was searching for an explanation for his illness really, regardless of what it was called, an explanation for it.
A yes.

Q You acknowledged, as we saw yesterday in your letter to Dr Wraith, that she was Child 4’s mother and she knew him better than any of you.
A Yes.

Q So in June 1996, the movement, if you like, to approach another specialist team came from Child 4’s mother.
A Yes.

Q The letter that she must have produced at your surgery, at page 125, I just want to ask you a couple of extra questions about it. It is irritating because it looks as though the copy that we have and you have I think is cut off at the top.
A Yes.

Q Because the whole of the address does not appear to be there in the printed part of the document. I just want to ask you about the annotations on it. You say “ECR” with the ringed “John Walker-Smith” is in your handwriting and you wrote on it at the time.
A Yes.

Q There is a handwritten address at the top which may not be the full address:

“Royal Free Hospital
School of Medicine
Rowland Hill [Street]
London NW3 2PF”.

A Yes.

Q Now, you say that was not written by you.
A No. That appears to be in the same handwriting as the “Blood tests history”, and that was not written by me, or to my knowledge anybody else in the practice.

Q If it was not you, it either has to be somebody else in the practice or Mrs 4.
A My assumption is that it was Mrs 4. I would be surprised if anybody else in the practice had written both those annotations.

Q That is the address in fact to which you wrote your referral letter, is it not?
A I notice that my referral letter is to the Department of Experimental Gastroenterology and I do not know where I got that address from; I can only assume it was on this letter, because---

Q Well, that is why I started by saying it looks as thought the top has been cut off, because we come in certainly some way through the printed part.
A It is a fairly unusual address for me to conjure up, the one I referred to.

Q Well, certainly the last five lines of it, as we see it there, are reproduced in the letter that you wrote, are they not?
A I think it would be a reasonable assumption that the first two lines were on top of the letter.

Q Again we know that it was written to Dr Wakefield although you had been given information anyway about a possible ECR and somebody called John Walker-Smith, about whom at the time you had no knowledge.
A I have no recollection of having any knowledge.

Q The other annotations on the left hand side look to be a summary of what might happen at that hospital, do they not?
A Yes.

Q So it is:

“Blood tests
1 week in hospital

underlying problem
treatment to help
diarrhoea – weight loss & Autism”

A Yes.

Q So is it reasonable to say that this was written by Mrs 4, and that is what she was anticipating would happen if he was admitted?
A That would my assumption.

Q Because you had been involved for a number of years looking after this child, it was not simply a question of you just writing off a letter to the Royal Free and saying, “Would you look at this child”, you wanted to find out more about it?
A Yes.

Q Which prompted the telephone call to Dr Wakefield, and I assume, because there is nothing in handwriting on the letter, his telephone number would have been the number that was printed on the top of page 125?
A I assume so.

Q Again, it has been cut off on this copy. Then you wrote the letter at page 121, the referral letter. Just a couple of things about that. Could you just turn that up. You give a history of the most recent investigations that had been contemplated – the question which we saw yesterday with Dr Wraith about whether or not there was a metabolic disorder.
A Yes.

Q Point that out to him, and the letter which Dr Wraith wrote in relation to that, which appears to have been to some extent a dead end, that investigation.
A That was a dead end. I think it was a copy of the letter I wrote to Dr Wraith, rather than the one that Dr Wraith wrote to me.

Q As we have seen, Dr Wraith was pessimistic at the outset and he---
A He did not think it was his province.

Q In the middle of that second paragraph you say:

“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.”

A I am not now entirely sure of that. I think it would appear that he had measles in 1988, and again on reflection I think the computer records that I referred to yesterday are probably incorrect, because going back nearly twenty years our computer was in a very rudimentary system, so I think it was probably measles, not MMR.

Q There are certainly two paper records, are there not, that suggest that it is measles in 1988?
A So I think that entry on page 121 is actually incorrect.

Q You were taken to these letters in the reverse sequence, but it looks as though you write to Dr Wakefield first, and on the same day you write to Mrs 4 telling her what you had discovered from having spoken to Dr Wakefield. That is at page 123.
A Yes.

Q Having had that discussion, you would not have made that referral to the Royal Free if you thought that the referral was inappropriate, would you?
A No.

Q The reason for the referral, as you have said, is to try to get on top of the problem with Child 4, which, for all the investigation, had not really been solved at that stage?
A Yes.

Q You were reassured by the fact that this was an NHS referral from the outset, it was a referral to a London teaching hospital with a reputation, a good reputation, and for that reason you had no qualms about doing so.
A Yes.

Q I think you knew at the outset, from the discussions that you had, that the programme at the Royal Free Hospital would involve colonoscopy and biopsies being taken?
A I would suspect so, yes.

Q Then in terms of sequence you received from a Dr David Casson, the lecturer I think in fact he is described, 16 October, at page 117.
A Yes.

Q It is quite a detailed letter, is it not, the discharge summary, which includes what their findings were anyway, and it concludes by saying that the colon was normal, under “Colonoscopy” on page 119.
A Yes.

Q “Colonoscopy was performed under sedation. There was mild granularity of the rectum with slight distension of the vascular pattern. The colon was normal, however, the ileum shoed marked lymphonodular hyperplasia. Histology of the ileum showed a dense lymphoid aggregate with no obvious acute inflammation and normal architecture. Within the colon there was noted to be several prominent lymphoid follicles but again no active inflammation. Rectum was normal. There were no granulomas.”

Bearing in mind this is written by a gastroenterologist to a GP, it may be that those findings did not mean an awful lot to you at the time?
A They would not have meant very much to me.

Q On the last page, page 120, it says:

An ECG was performed which was normal. An echo cardiogram needs to be performed when we see him next.”

It should, I think, be “An EEG was performed which was normal”. So this does not come up with a conclusion as to what is causing the problems, does it, that discharge letter?
A No.

Q It describes the findings which may or may not have been in this case very helpful to you, but obviously it prompted, from the documentation it must have prompted you, to go back to Dr Wakefield and find out what, if anything, the findings meant?
A I would assume that, yes.

Q With respect, I think you are right about the timings of it, because if you look back at the note, if you would again look at the general practice note on page 9 and over on to page 10, it starts on page 10 with the phrase “re GI abnormalities”, so “re gastrointestinal abnormalities”, and presumably that is a reference to what was being described as an abnormality in the colon in the part that we just looked at?
A I would assume so. As I say, I think this phone call clearly was following the receipt of the discharge letter, so I would assume that was the discussion, whether those were abnormalities, because I would not be very familiar with that.

Q Yes. I think basically you were asking, “Well, what does this all mean?”
A Yes.

Q You get not only the suggestion that this may be a new syndrome and the explanation for it, according to your note, which may be disappointing, “No idea of treatment yet”.
A Yes.

Q Then I think the first time you received correspondence from Professor Walker-Smith in March 1997 was page 111.
A Yes.

Q With a suggestion of treatment, possible treatment, with an anti-inflammatory drug, and that was tried but he did not respond well to it and it was stopped after a very short time.
A Yes.

Q I think your position was that this was not a drug which you would have contemplated prescribing off your own back as a general practitioner, but if it was being recommended by a specialist centre in paediatric gastroenterology then you were prepared to follow that advice?
A Yes.

MR MILLER: Thank you, Doctor.


MR HOPKINS: No questions.


Re-examined by MR THOMAS

Q There is only one matter, Dr Tapsfield. Can I again ask you to look at the note on pages 9 and 10?
A Yes.

Q You were asked some questions about this, both by Mr Coonan and by Mr Miller and Mr Miller suggested to you, and I think you accepted, that this was at least possible, that you had noted “re GI abnormalities” as a result of the discharge summary that you had received giving you the findings on colonoscopy.
A Yes.

Q Where did the rest of the information in that note come from?
A That would have come from the telephone conversation.

Q Yes, and where did the information come from? Who provided you with the information?
A I would assume from the records that it was provided by Dr Wakefield.

Q Does that extend to the comment “No idea of treatment yet”?
A I would assume that, yes.

MR THOMAS: Thank you.

Questioned by THE PANEL

THE CHAIRMAN: Dr Tapsfield, if there are any questions from any of the Panel members then I will now introduce them to you. Mrs Dean is a lay member.

MRS DEAN: Good morning, Dr Tapsfield. I want to ask you just about one thing, the letter on page 111, which I think is from Professor Walker-Smith about the treatment.
A Yes.

Q There are a number of handwritten notes on that letter and I believe you told us yesterday that is your handwriting?
A Yes.

Q I wanted to ask, the comment that says “not recommended for kids”, and the line, is it that you are saying capsules are not recommended for kids or is it that the medication is not recommended for kids?
A I could not comment on that.

Q You cannot comment?
A I cannot recall, and I cannot recall how I got that information, so I would not know whether I was referring to the medication as a whole or the specific preparation. I would imagine it would be the medication as a whole, but I really cannot comment.

MS DEAN: Thank you very much.

THE CHAIRMAN: Dr Tapsfield, I have only got one question for you as well and that is actually the number of telephone calls with Dr Wakefield.
A Yes.

Q What we have seen from the documents, and I think you have actually probably said that that sounds to be correct, is the first telephone call that you actually made with Dr Wakefield was somewhere about 1 July.
A Yes.

Q That is actually on page 121.
A Yes, somewhere between the conversation with his mother, who brought in the letter, and the referral letter, sometime between that I would be sure from the records that I must have had a conversation with ….

Q That is why I said somewhere about 1 July.
A Yes.

Q The second telephone call would have taken place, again according to your handwritten documents and Lloyd George records, on 21 November 1996?
A Yes.

Q There was no telephone call in between that you can remember?
A I have no recollection of one. I cannot recall any conversation.

Q Again, your recollection, and supported by the documents, is that there was no further telephone call after that?
A I would be surprised if there was any telephone call between July and November because there would not have been a reason to make that call. I do not know. After that
I might have made telephone calls to find out about treatment, I do not recall that, so I cannot comment about telephone calls after November. It is possible there were some, it is possible there were none.

Q What is the more likely? I think I am going in the wrong direction, so yes, I take my question back. Thank you. I do not think the Panel have any more questions. Mr Thomas?

MR THOMAS: Nothing arising out of that.

THE CHAIRMAN: Mr Coonan, Mr Miller, Mr Hopkins? (No questions) Dr Tapsfield, you will be very pleased to know that you are at last now released. Thank you for staying overnight, thank you for organising your surgery arrangements for this morning.

THE WITNESS: Thank you.

(The witness withdrew)

MS SMITH: Sir, the next witness is Dr Stuart and there is a very short matter which we need to discuss with the defence. I wonder, would you mind taking a very short break then and then we will run straight through? As I say, it will not take us very long, but we have not had the opportunity to do so.

THE CHAIRMAN: We will now adjourn. I am not giving a time period, so we will just wait until you call us, maybe in the next five, ten minutes.

MS SMITH: Yes, thank you, sir.

(The Panel adjourned for a short time)


MS SMITH: Thank you very much, sir. I am sorry we were a little longer than we hoped to be but I am afraid these issues arise and have to be dealt with, and we try to do so as quickly as possible.

THE CHAIRMAN: We understand and I am sure that these things we will end up resolving one way or the other.

MS SMITH: That is very kind, sir, thank you. We are conscious of the time constraints and we will do our best. I will call Dr Stuart now, please.

THE CHAIRMAN: Can you give us an idea which Child number this is?

MS SMITH: I am so sorry, Child 12, so you will need the GP records for Child 12.

Examined by MS SMITH

(Following introductions by the Chairman)

Q Dr Stuart, I am rather a long way away from you, so please tell me if you cannot hear me.
A I am fine, thank you.

THE CHAIRMAN: If I may request, can you please speak clearly and loudly. Pull the microphone closer to you to make sure that we are able to hear everything that you have to say. I am sorry for interrupting.

MS SMITH: No, not at all. Thank you very much.

(To the witness) Dr Stuart, could you first of all tell us your full name and your professional address, practice address?
A My full name is Dr Mary Helen Stuart and I am a general practitioner at 18 Hove Park Villas in Hove, Sussex.

Q If you look in front of you on the table you should have a laminated sheet which is called the anonymisation key.
A Yes.

Q We are referring to the children in this case by a number in order to protect their confidentiality. If you look down to the bottom, Child 12, is that the child who was at one time your patient in the practice?
A Yes.

Q Can I just say, could you try to refer to him as Child 12 when you give your evidence, but do not be too worried if you slip. We are all doing it and the press are aware that they should preserve confidentiality. I think it is right that you were Child 12’s GP from birth until around about late 1997?
A That is correct.

Q He was born in December 1990. Could I ask you to look in the file in front of you, please, which is his GP records, at page 10?
A Yes.

Q Are you on his vaccination sheet?
A Yes, I am.

Q Thank you, and if we look down at the right-hand column does that show that he had the MMR vaccination on 6 March 1992?
A It does.

Q Then, if we go into the records I just want to ask you a few questions about what they show about his health and development, Doctor. Would you turn to page 15, first of all. There is an entry on 29 July 1994 in the right-hand column. Is that in your handwriting?
A 21 July? Sorry, yes, it is, correct. 29 July, yes.

Q Could you just read it? It is “Vomiting & loose motions”, Is that right?
A Yes.

Q “Sleepy, reluctant to eat”?
A Yes.

Q “Abdomen soft”?
A Yes.

Q What does it say next?
A “Pulse 110.”

Q Then a diagnosis of a viral illness and you gave reassurance. Is that correct?
A That is correct.

Q I think there came a time when there were concerns expressed in relation to his development generally and if we look at page 144 of those records we will see a letter to you in May 1995. That is a letter from the senior registrar in community paediatrics.
A Yes.

Q If I can just run through it:

“[Child 12] was reviewed on 27 April 1995 at home. There had been a very good behavioural response to the star chart with only an episode of soiling over the past week. [His] behaviour continues to be otherwise difficult.”

Then it gives various aspects which were age appropriate, but then says:

“In Eye/Hand coordination however, [Child 12] had considerable difficulty and became frustrated, refusing to perform …”.

Looking down to the next paragraph:

“Although [Child 12’s] comprehension seemed good, his answers to questions were somewhat immature …”,

and then it was set out. Then on the next page:

“The impression is that although [Child 12] has considerable behavioural overlay, he also has genuine difficulty in performing some tasks, particularly fine motor”,

and there is a suggestion of occupational therapy assessment, speech and language therapy and the matter was to be discussed with the health visitor with a possible referral later to Child and Adolescent Mental Health Services. So at that stage it would appear that there had already been some difficulties in relation to soiling which were being addressed. Is that correct?
A That is correct.

Q And also, as we have heard, to developmental delay. Then in May 1996, if you go on to page 129, please, this is a letter from a staff grade doctor in community paediatrics, copied to you, to a consultant psychiatrist. Is he local, Dr Blincow?
A Yes, he is.

Q It says:

“I should be grateful if you would see [Child 12] who has speech and language difficulties and emotional/behavioural difficulties. He is described by his mother as a lovely affectionate child but very over the top about everything.”

Then it says he has extremes on the emotional spectrum, and then going on down in that first paragraph:

“He often complains of pains in his legs and tummy and suffers from recurring unexplained pyrexia [that is temperature] every two months which gets better after staying in bed for a couple of days.”

Then, going on to the next page:

“He is difficult with food, eating only a narrow range and will hardly eat for days, then eats like a horse. He appears to be growing quite well in spite of this.”

There are problems with bedwetting and problems with soiling, three times a week despite daily bowel opening.

“[Child 12] does not soil at school. He is said to be very happy and now well settled after initial boisterousness and aggressive behaviour”,

and there were suggestions in relation to art therapy whilst he was waiting to be seen for assessment. Then we have a reply from the psychiatrist at page 127. Again, this was a letter that was copied to you. If I can just read through this briefly, Dr Stuart, this time he attended with his siblings.

“[Mrs 12] was seeking my attention as to whether [Child 12] had Asbergers Syndrome as well as looking at the strategies for managing him. The current difficulties are that [he] is continually talking or making noises and that his effective response to situations can be extreme and unpredictable. His mother recognised that he has been ‘different’ in some way since 18 months old. He soils most days though he is not apparently constipated. He seems oblivious to this …”,

and then it goes on with various behavioural problems. Going to the bottom of the page:

It has been suggested both by Hugh Clench and Helen Hopkins from Woodlands”,

which is the assessment centre,

“that [Child 12] could be on the autistic spectrum. While Mother had read up about hyper activity and concluded herself that this did not fit [Child 12] she has since …”,

and then there is a blank which I am guessing from the context might be “read about.” I am sorry, are you with me?
A I am sorry, I think I am on the wrong letter. I am in a letter from Dr Ing.

Q That is it, the consultant psychiatrist.
A Okay, yes.

Q I am looking at the top of page 128.
A Fine, okay. I am with you.

Q I do not know if you have got a blank, have you? “… she has since …” and then there is a blank at the top of the page?
A Yes, there is a space.

Q Then:

“Asbergers Syndrome and feels that the description fitted him exactly.

Medically [Child 12] is apparently frequently unwell, being prone to infections and stomach aches. Periodically he has had high temperatures and been delirious after which he may sleep for a couple of days. To illustrate his susceptibility to infections his Mother told me that [Child 12] had Measles months after having had his MMR.”

Then going down to the bottom of the page Dr Ing gives his impression of him and he says in the last paragraph:

“I would agree with the possibility that [Child 12] has Asbergers Syndrome. I intend to get further information from [the school] … to support this and I have arranged to meet [Child 12’s] Mother to discuss the subject further.”

So that would appear to be the first tentative formal diagnosis, the possibility of Asbergers Syndrome. Is that correct?
A Yes.

Q Did there come a time when you became aware of some work that was being done by Dr Wakefield at the Royal Free Hospital?
A Yes.

Q Can you tell us how you first became aware of that work?
A The mother of Child 12 came to discuss it with me.

Q Do you have any recollection of what in fact she said to you, how she herself had come by the information?
A No. I saw relatively little of the child at this period. Most of these assessments were being done by the community paediatricians and psychiatrists and the child’s mother would come in and discuss the child with me but without bringing the child in. As I recall, she had somehow gained knowledge that there was a study being done and she came and said that she was keen for her child to be involved in the study and that I would be contacted by Dr Wakefield with some further information.

Q Could I ask you to go to the clinical records in the GP notes at page 11?
A Yes.

Q There is a note at the top of the page, 19 July 1996. That note says:

“D [diagnosis] ‘Autism’. M [mother] anxious re MMR & Autism & Crohns but no blood pr [per rectum]. 0 [no] symptoms of obstruction.”

Was that note in fact written by one of your partners rather than by you, Doctor?
A Yes.

Q Can we turn on to page 126? This is a letter to Mrs 12 herself from Dr Wakefield, dated 19 July 1996:

“Dear [Mrs 12]

Thank you for your letter regarding your so. We have recently taken a profound interest in this subject, particularly in view of the link between bowel problems and Asperger’s Syndrome. I would greatly appreciate if you would mind calling me at the Royal Free before 3rd August and in addition I would like you to seek a referral from your GP to Professor John Walker-Smith, Professor of Paediatric Gastroenterology at the Royal Free Hospital, for investigation. It will be necessary for me to discuss the nature of the referral with your GP and I would be very grateful if you could let me have his/her name telephone number. Also could you please let me have your telephone number so that I can speak to you directly on the subject.”

Can you help us as to how that letter, which is to Mrs 12 and addressed to her, came into the general practice records or how it would probably have come about?
A As I recall I think she probably bought it in and gave it to me.

Q Did she ask you to make the referral that is suggested in that letter?
A She did.

Q Were you content to do that?
A She told me I would receive a telephone call from Dr Wakefield with some further information and the decision was to be deferred until after that had happened.

Q If we turn back to page 11, was one of the matters that occurred to you, when you were first asked about this referral, the funding issue?
A I think it may have been. I am not entirely sure but I think it probably was considering the note I made on the 11.9.96.

Q That says “Call to Sheila Maxwell”, is that right?
A Yes.

Q “By T” for telephone?
A Yes.

Q “ECR referral”.
A “? ECR”. I was not sure one was required.

Q I will revert later, if I may, to the funding issue because I want to go on and ask you about the call that is referred to just above the note. Can you read the date, first of all, in July 1996?
A I think it was probably 30 July.

Q It is very unclear from my copy of it. Is that a note by you?
A Yes.

Q Can you read out exactly what it says?
A “Call from Dr Wakefield. Needs colonoscopy B12 absorption tests. History of measles vaccination reaction.”

Q The “needs colonoscopy B12 absorption tests”, where would you have got that from?
A From my conversation with Dr Wakefield.

Q Do you happen to recall anything outside that note - we appreciate it is a long time ago - about the contents of that conversation?
A I am afraid I cannot.

Q As far as the words “history of measles reaction”, where would that have come from?
A I am not sure but I would image that was included in the conversation. I think this was an idea that had come from Child 12’s mother.

Q As far as the general practice records are concerned, did you have any record or knowledge of a reaction to the MMR vaccination?
A No.

Q He had the vaccination we know, we have already looked, in March 1992. If we go back to the GP records for that period, which is page 16, you will see, at the bottom of the page, third entry up, 6 March 1992 “MMR given”. There are two prescriptions thereafter in 1992. What do they relate to?
A They were prescriptions for Timodine cream, which was prescribed for nappy rash, candida with nappy rash, or very possibly eczema. I cannot recall. That would be compatible with the child’s age at the time.

Q If we go over to the next page we see there is an entry in July 1993 and then one in March 1994. Do either of those entries have anything to do with reactions to MMR?
A Page 17, do you say?

Q Page 15.
A Could you remind me of the dates?

Q One in July 1993 at the top of the page and the next one is March 1994.
A Yes, the July 1993 refers to a further vaccination, Hib vaccine, and the March 1994 refers to eczema.

Q Taking you back to the history of the measles vaccination reaction that you have recorded when you had the conversation with Dr Wakefield, where do you think that information would have come from?
A I think it either came from that conversation or from the conversation I had with
Child 12’s mother seeking the referral.

Q As far as the note that you have made, if you just turn back so it is in front of you, the note at page 11, the reference to needing a colonoscopy and B12 absorption tests, you say you must have got that information from the contents of the telephone conversation. Would you have had any thoughts of this child needing either of those tests?
A No.

Q In fact the actual referral letter from you to Dr Wakefield is on page 124. It is not dated until September 1996 and then it is addressed to Professor Walker-Smith for the attention of Dr Wakefield. It starts off, “Thank you for seeing 12 who we have discussed on the phone recently.” Would that be a reference back to the July telephone call I have taken you to?
A Yes, it would.

Q Can you explain why there is a significant delay between the July call and the actual referral letter?
A I imagine it was to do with the funding issue. I do not think I was clear as to whether we needed to seek funding. The local PCT, or whatever they called themselves ten years ago, were fairly slow in responding to requests from us at that time.

Q Looking at the contents of that letter:

“Thank you for seeing [Child 12] whom we discussed on the phone recently.
[Child 12] initially presented at his eighteen month check with delay in talking and
communication skills. He was seen locally at the Speech Therapy department and
On examination at that time his abdomen was normal with an empty rectum. He has been seen by Dr Ing, our local Consultant Child and Adolescent Psychiatrist, who has expressed the opinion that [Child 12] may well have Asperger’s Syndrome.

I look forward to hearing your opinion regarding [Child 12’s] further investigation and outlook.”

As far as that letter is concerned, we can presume from that that you were happy to make this referral?
A Yes.

Q To whom did you understand you were making the referral to and what were you making it for?
A I was making it at the request of Child 12’s mother who had been in contact with community paediatricians, psychiatrists and other professionals and had gleaned this idea that there may be an association between the MMR vaccine and autism and bowel disease. She was requesting her child was involved in the study that was being performed at the Royal Free Hospital.

Q Who was it, in your understanding, that the actual referral was to? We see
Professor Walker-Smith’s name at the top of the page and then “for the attention of Mr Wakefield” and the letter addressed to him. Did you have any understanding of the respective roles of the doctors?
A I believe that format was requested as a result of the conversation I had with Dr Wakefield, that the Professor was heading up the department but that it was Dr Wakefield’s project.

Q You had a response to that letter three or four days later, page 118.
A Yes.

Q That was just a brief letter written on the 27 September thanking you for your letter and saying that the doctor would be delighted to see Child 12. In fact, that letter was on behalf of Professor Walker-Smith.
A Yes.

Q Did Professor Walker-Smith write to you again in October having seen Child 12? We can see that letter on page 116.
A Yes, he did.

Q He says:

“Thank you so much for referring [Child 12], certainly he seems to fit the spectrum of autism. I am interested that he in fact does not have very significant gastrointestinal symptoms although as you say he has had some soiling. I note you found his rectum was empty. When I examined him today he certainly had no evidence of faecal loading. He is gaining weight and growing satisfactorily. Some of the previous children I have had referred to me with autism have had clear cut gastrointestinal symptoms with quite severe abdominal pain and intermittent bleeding and we have gone ahead with our programme of colonoscopy and intensive investigation. However in [Child 12’s] case there is relatively minor gastrointestinal symptoms. I felt it right to perform a full blood count ESR, CRP and I will discuss further with [Mrs 12] concerning the need for intensive further investigation and if the parents wish us to proceed we could certainly arrange this. For the moment I have told [Mrs 12] to be in touch about the results of the blood tests and I have not given another out-patient appointment.”

As far as that letter is concerned, did Professor Walker-Smith’s view that there were not very significant gastrointestinal symptoms although there had been some soiling accord with your understanding of his gastrointestinal status?
A Yes, it did.

Q We know that, in fact, Child 12 did go on and was investigated. Did you play any part in the decision as to whether he should undergo what is described by Professor Walker-Smith as the programme of colonoscopy and extensive investigation?
A Not as far as I am aware.

Q It appears to be the case that Professor Walker-Smith intended to discuss the matter further directly with Mrs 12 and the child was investigated. Do you find it at all surprising that Mrs 12 agreed to these investigations?
A No. I think she was quite enthusiastic to look at every option that might help sort things out for her.

Q Normally speaking would you refer a patient outside your area to a clinician who was not a local clinician?
A It is an infrequent occurrence and generally more with adult patients. I would not normally do that for a child. I would usually go through our local paediatric department who would then usually make any secondary referrals on.

Q What was it that made this different?
A The mother’s enthusiasm for it.

Q If we go on in the records to page 113 we see a letter sent to you in November 1996 from Dawbarns Solicitors indicating that legal aid had been granted to enable those solicitors to investigate a claim for compensation following injury which appears to have been caused by vaccination and asking for the child’s medical records. Was that the first you knew of the involvement of lawyers in Child 12’s case?
A Yes, it was.

Q If we look on to page 115, just for completeness, that was the authority by Mrs 12 for her medical records to be released in October 1996?
A Yes, that is right.

Q Were you informed by Mrs 12 as to the fact that Child 12 had had investigations?
A I do not recall that I am afraid.

Q Do you recall when and how you ultimately did receive information as to what
Child 12 had undergone?
A There was a discharge note sent through.

Q We can look at that and it is at page 111. This is a discharge summary from the Royal Free and it gives a diagnosis of autistic spectrum, abdominal pain and started on Paraffin. Under “Procedures undertaken” we see colonoscopy, MRI and LP, lumbar puncture. There is actually a longer discharge summary contained in the Royal Free Hospital records but not in the GP notes. I want to ask you to look at that and tell us if you have any recollection of ever receiving it. It is on page 32 of the other file.
A Yes, I have that.

Q It is addressed to you and I will run through it so you know what the contents are. Having been seen in the clinic Child 12 was admitted to the Royal Free for further investigation of his gastrointestinal problems. He had been followed by paediatricians locally for one year because of poor apgars. Nevertheless his development was recorded as normal until 16 months, subsequent notice loss of language skills, stopped playing, his behaviour had progressively deteriorated.

Then going down to the next paragraph:

“In regard to gastrointestinal symptoms he was noted to be clean and dry by the age of 3 years, subsequent to this his soiling started and he is presently soiling up to 8 times a day. He does not realise he has opened his bowels and that he has soiled. The faeces are very pale, loose and smelly. The abdominal pain occurs approximately once a week, occasionally associated with vomiting and anorexia. He had his measles vaccination at 15 months of age and is fully immunised.”

It he then sets out the results of blood tests and says:

“A colonoscopy was performed under sedation. This recorded almost normal appearance to the caecum. There were minor changes in the rectum and the caecum these consisting of slight changes in vascularity and prominent lymphoid follicles. The ilial-caecal valve could not be identified. Histological report on the biopsies taken on this series do not show any significant abnormality. A barium meal and follow through demonstrated lymphonodular hyperplasia of the terminal ileum.

It was notable that following the bowel clear out prior to the colonoscopy [Child 12’s] behaviour appeared to improve as did his soiling. It is therefore conceivable that many of his problems are associated with a degree of constipation and in view of this he has been started on liquid Paraffin which should continue for six months.”

That discharge letter is not in the GP records. Do you have any recollection, having looked at it, as to whether you received it or not.
A I do not have any recollection of having seen it.

Q Thank you. As far as you were concerned, matters proceeded, because there is in the GP records, if you could go back to those now, a letter from Professor Walker-Smith on page 110, saying:

“We have had quite a remarkable success with the use of Sulphasalazine or 5 ASA derivatives in children with autism and evidence of lymphoid nodular hyperplasia and non-specific colitis as we found in [12]. I think it would be appropriate to consider a therapeutic trial of one of these agents, these drugs appear not only to help gastro-intestinal symptoms but also rather surprisingly helped behavioural symptoms. I have therefore suggested that you might consider a therapeutic trial of Olsalazine 250mgs
3 times a day for [12]. I would be very interested if you decide to do this to hear about his subsequent progress.”

Was he in fact, do you know, prescribed that drug?
A I do not recall. I do not think he was.

Q That was in April 97.
A I have not been given access to my notes covering that time, so I could not say for sure.

Q When you say access to your notes covering that time---
A That was three months after the admission for the investigations. If that medication had been prescribed it would have been recorded in my notes.

Q I see.
A I have not seen any such record.

Q Are you saying in other words the GP records we have have aspects missing?
A No, I cannot comment, basically.

Q Well, if you turn back to the next page, which is 109, that is in June 97 to you from
Dr Casson.
A Right.

Q So that is a couple of months after the previous letter:

“I reviewed [12] in Professor Walker-Smith’s clinic today. Basically he remains as he has previously. Unfortunately he has not persisted in taking the liquid paraffin as mum was concerned that it made his soiling worse. He still experiences occasional abdominal pain. He is otherwise well. Abdominal examination was unremarkable.

An abdominal x-ray was performed today which demonstrated marked faecal loading. I have discussed the situation with Professor Walker-Smith and we feel that we should initially start treatment with Olsalazine ... to asses whether this makes an effect. We should hold fire on treating his constipation.

We will review [him] in a months time at which stage it will be important to re-assess treatment and consider whether any further treatment is required.”

They did indeed review him in a month’s time, because if we go back another page to page 108, this one is from Dr Malik, who is another of the registrars in the department:

“I reviewed [12] in Professor Walker-Smith’s clinic today. He has been on [Olsalazine] for almost 4 weeks. According to mother this has not made a remarkable difference in his behaviour although he has been opening his bowels more regularly. I have not made any further appointments to see him but I [have] taken a plain xray to ensure his abdomen is better. He needs to continue with liquid paraffin. It is advisable that he should continue on [Olsalazine] for at least one year. I would be obliged if you could keep prescribing … In our experience most of the children have improved on anti-inflammatory medicines.”

As far as the paraffin was concerned, Doctor, what was that a prescription for?
A A laxative.

Q If we just have a look at page 12, Doctor, have you got the records for that page?
A Oh yes, I have. That makes it easier, does it not?

Q Yes. If you look down at 2 June 97 you will see that there was indeed olsalazine, and I think that is “Recommended”, is it, “by Royal Free”?
A The Royal Free, that is correct.

Q He did indeed have that prescribed to him. Now, just turning back, Doctor, to the time when you referred this child, can you help us as to what exactly your understanding was of the investigations that were being carried out at the hospital? The reason why you referred, you have told us, was because the mother wanted these investigations done. What was it your understanding that the investigations were for?
A To investigate the possible connection between MMR vaccine reactions, inflammatory bowel disease and autism, and Child 12 had by that stage had a formal diagnosis of autism.

Q Yes. That is the Asperger’s, is it?
A Yes. That is considered to be part of the autistic spectrum disorder.

Q Absolutely. When you say that was your understanding, where did you derive that understanding from?
A From what Child 12’s mother came and told me. I had not been aware of it prior to that.

Q As far as you were concerned, since the mother was keen for this to happen did you have any problem in referring to the Royal Free Hospital?
A No.

Q Did you understand when you referred the exact details of the investigations he was going to undergo, or was that a matter that you would leave to them?
A After the telephone call from Dr Wakefield, the colonoscopy and B12 absorption studies were mentioned.

Q Yes.
A I do not recall if there was any other detail at that time.

Q We know from the brief discharge summary that I have take you to that afterwards you were told that he had had an MRI and a lumbar puncture; do you recall whether or not they were mentioned to you at any time prior to his actually going into hospital?
A I cannot recall that, I am afraid.

Q As far as Dr Wakefield telephoning you and speaking to you directly about these matters, is that a common occurrence in your practice?
A No.

Q How would you describe it?
A Probably a one off. I do not recall any other similar phone calls from any other referral doctors.

Q How long have you been a general practitioner?
A 24 years.

Q Did you think at the time that there was anything in the idea of a possible link between MMR and autism and bowel disease?
A I did not really have a view at that time, but the child had been seen in our local paediatric unit, and I believe had been assessed at Guy’s Hospital, so my feeling was these were both eminent authorities and the idea may have come to the child’s mother following discussions with those people, but I had no previous knowledge of the theory that was going around at that time.

Q Now, I just want to ask you a number of short questions, Doctor, about the finances behind this, which we have already touched on, and we refer to the notes in the records that you made at the time querying whether it was an ECR. Have you in fact thought about this matter and do you have any clear information you can give us as to how you thought this referral was being funded?
A I think at that time, when the request was presented to me, I was not aware of how the funding would be arranged. At that time certain of the London hospitals were in contract, so to speak, to the Brighton authorities and did not require any additional funding, and they used to send through lists, and the list would vary from year to year, and I would imagine at the time that the request was presented to me I needed clarification on it.

Q Right. When you say they were in contract, if a referral was made by a GP to a hospital either inside or indeed outside the contract, who was it your understanding that the ultimate funder was? Where did the money come from?
A My understanding would have been that it was the Sussex/Brighton authorities that would have funded it.

Q When you say Sussex/Brighton authority you mean health authority?
A Yes.

Q In fact, if it helps at all, if you can just go to the Royal Free Hospital records, please, page 131, this is a request in fact signed by Dr Wakefield in relation to one of the investigations that was undertaken on Child 12, and if you look just about two-thirds down the page it says “Ward/Clinic Malcolm”, and then do you see there is an “ECR” circled?
A I am sorry, which page are we on?

Q Page 131 of the Royal Free records, not the GP records.
A Oh, yes, I see it.

Q Do you see where I am?
A Yes.

Q If that were the case, and I appreciate you are not sure whether this was one which came within the contract or was extra contractual as far as the health authority was concerned, but if it was an ECR, again can I ask you where is it your understanding that the money came from for an extra-contractual referral?
A From Brighton.

Q Again – the health authority?
A Yes.

MS SMITH: Thank you very much, Dr Stuart. If you stay there you may be asked some questions.

THE CHAIRMAN: Dr Stuart, I think as I did explain to you earlier, the three doctors’ representatives have the opportunity to cross-question you on the evidence that you have just given, and Mr Coonan on behalf of Dr Wakefield is going to start first.

Cross-examined by MR COONAN

Q Dr Stuart, can you just help a little more about the system of ECRs which existed at that time, and we have been told that the situation has changed over the years, but at that time in 1996 by the sound of it if a GP in your position wanted to refer a patient out of area, as it were – that is my expression – out of the immediate area, there might be a question raised by the local health authority as to whether or not they would be prepared to pay for that referral.
A Yes.

Q So in other words, from the standpoint of a GP considering such a referral there would be possibly a degree of uncertainty as to whether that would eventually happen?
A Yes.

Q Because the situation at that time was that the health authority were given the power in relation to the fund-holding arrangements at that time to exercise some form of financial control over out-of-area referrals?
A Yes, that is my understanding.

Q Sometimes the health authority at that time when considering a proposed referral could say “No”.
A Yes, they could.

Q They could say “No, this referral must be to a local facility, a local provider”.
A Or they may offer an alternative.

Q Yes.
A Yes, to a non-local provider.

Q Whichever way it would be, there was uncertainty?
A Yes.

Q Now, can we just go back to the beginning, as it were, and I just need to seek your assistance really about, and touch on, a maximum of three documents. Mrs 12 brought in a letter which she had received from Dr Wakefield, and that is page 126. Can we just go back to that. This letter is dated 19 July. She brought it in and you obviously read it, did you not, and absorbed its contents?
A Yes.

Q Was it the case then that Mrs 12 was asking you for a referral in effect to Dr Wakefield?
A It was.

Q She told you that she was very keen that a referral should take place and that
Dr Wakefield would in fact be phoning you to explain more about the background.
A Yes, that is correct.

Q I suppose that you were, in the circumstances, and bearing in mind what the mother was saying to you, that no doubt you would have been pleased to have further clarification as to the background of any proposed referral?
A It seemed very reasonable, yes.

Q Because if the mother is coming in and explaining a basis that you were unfamiliar with, it would be extremely helpful to have, as it were, from the horse’s mouth exactly what was going to be involved should a referral take place?
A Yes.

Q When Dr Wakefield telephoned you, and we can see from page 11 that he did telephone you---
A He did.

Q ---from this very poorly photocopied note, clearly that note there is a clear reference to the anticipation raised by the mother to you that Dr Wakefield would be calling, and here it is, he is calling.
A That is correct.

Q Now, your note is quite a short note. It just reads, does it not, as you have told us, “needs colonoscopy . B12 absorption” and then a reference to a history? That is quite a short note.
A Well, it was followed up by a large document that Dr Wakefield sent me in the post.

Q Ah! Well now, where is that document?
A Well, I did not keep it. I mean, I looked at it at the time. It was a document concerning the study that was being carried out, but, I mean, I have disposed of it. The child left our list about a year after this event.

Q Right. So let us just understand it. It is not a criticism, it is just a new piece of information. So Dr Wakefield sent you some information following his phone call?
A Yes, it was background information about the work they were doing.

Q The letter of referral we know was on 23 September 1996, page 124.
A Yes.

Q You were asked about the delay. Now presumably the document or information that Dr Wakefield sent to you was sent to you before the letter of referral?
A Yes.

Q So when you made the referral on 23 September 1996, page 124, you had had the advantage of a telephone call with Dr Wakefield and a document?
A Yes, that is correct.

Q You would have been in a position to make a professional judgement as to whether or not it was in the child’s interests that the child be referred to the Royal Free?
A Yes.

Q You were clearly satisfied, were you not, that it was in the child’s interests that he be referred?
A Yes.

Q Was the document that was received by you a lengthy document?
A It was. It was quite a few pages. I am afraid I cannot remember the contents.

Q Do not worry, it is 11 years ago.
A It was too fat to file in the child’s records.

Q So quite a lot of information, and was there quite a bit, if I can put it this way, of science in it?
A There may well have been.

Q I just want to know, please, whether I can succeed in jogging your memory a little at least about this telephone call. If you say to me there is no way you can remember after
11 years then do not hesitate to say so, but can you remember Dr Wakefield telling you that he had a research interest at the Royal Free?
A I think he did.

Q Can you remember him saying that this research interest was from a scientific standpoint?
A I could not recall that.

Q Do you remember he telling you that he had been told by Mrs 12 of Child 12’s symptoms?
A I understood they had been in communication with each other.

Q Absolutely, but again do you remember him saying to you that he knew about Child 12’s symptoms?
A From what I can recall I understood that he felt that this was a child that would be suitable to be referred, presumably based on the symptoms, but I really do not remember those details.

Q That is fine. Do you remember him saying to you that the child’s symptoms were similar to the symptoms of other children who had been assessed and investigated at the Royal Free?
A I do not remember.

Q The thrust of this conversation, Dr Stuart, was this, was it not, that he was giving you background – more was to follow in the documents – of the sorts of investigations that might be undergone by a child if the child were assessed as suitable?
A Yes.

Q In other words, once a referral took place, the child would have to be assessed at an outpatient appointment by the clinicians to see whether or not further investigations would follow?
A Yes.

Q Is that right?
A I would imagine so, yes.

Q Again, I am going to suggest to you that he mentioned that investigations which some of the children who had been seen at the Royal Free had had included a colonoscopy?
A Yes.

Q It may be a matter of common sense, but let us see whether we can agree. Dr Wakefield himself could not ask you to refer this child, could he? He could only suggest that, on the face of it, the child seemed to be suitable?
A Yes, that is correct.

Q Because you were the one who had to decide whether to refer or not?
A Yes.

Q Did he suggest to you that the referral to clinicians – and I touched on that a minute ago – would, in effect, be a referral to Professor Walker-Smith?
A I suppose at the time I was not clear what function the two of them performed, but
I understood that the Professor was the lead in the department, so referral letters went to him, and that Dr Wakefield was doing the research.

Q The fact that you were not sure about the relationship between the two of them – not a criticism of you at all – but your letter of referral really, as it were, was to both of them?
A Yes.

Q So is what you are saying that at the time of the referral you were not clear who was wearing the clinical hat?
A I assumed they both were.

Q You did make that assumption, did you?
A I would have assumed so, yes.

Q Of course, after the child was referred all the correspondence coming back to you was from Professor Walker-Smith or from others in his department?
A Yes.

Q Not from Dr Wakefield?
A That is correct.

Q Putting it in a nutshell, your understanding was that Dr Wakefield was, as it were, running the science?
A Yes, I guess so. Yes.

Q So if we just look for a minute at the note on page 11, where it says “needs colonoscopy”, would you agree with me that one has got to be a little careful before reading that as a sort of literal request?
A Absolutely.

Q One has got to put this in context. Do you agree?
A Yes. I think these were possible outcomes.

Q Possible outcomes, absolutely, thank you. By that, “possible outcomes” really means “possible investigations”?
A Yes.

Q Depending upon assessment at an outpatient’s appointment?
A Yes.

Q Having had the conversation with Dr Wakefield and having received this documentation, as you have already said, you decided to make the referral, which had been, had it not, in effect entirely at Mrs 12’s instigation?
A Yes.

MR COONAN: Thank you very much indeed, Dr Stuart.

THE CHAIRMAN: Mr Miller will be asking questions on behalf of Professor Walker-Smith.

MR MILLER: In fact, he will not be asking any questions.

THE CHAIRMAN: Thank you. Mr Hopkins?

Cross-examined by MR HOPKINS

Q Could I invite you, please, to go to page 132 of the GP records? Dr Stuart, just so that you understand the purpose of these questions, it is just to explore in a little more detail the background history that Child 12 had before arriving at the Royal Free. If we look at page 132, do we see a letter dated 29 March, 1996, that comes from Helen Hopkins, who is described on page 133 as a family centre worker at the Woodlands Family Centre?
A Yes.

Q If we turn to page 132, so the first page, is she in fact writing to you and setting out some information about a meeting that she had had with Child 12’s parents?
A Yes

Q If we look in the second paragraph, she says:

“When I last met [Mr and Mrs 12] on 28th March 1966, [Mrs 12] was feeling very stressed and low about [Child 12’s] continuing soiling.”

A Yes.


“[Mrs 12] has to change [Child 12’s] underpants up to 4 times before he goes to school in the morning and he often comes home from school heavily soiled.”

Then she goes on to say:

“[Mr and Mrs 12] do not feel that the problem is due to constipation, as [Child 12] passes regular motions once or twice a day. [Child 12] appears unaware that had soiled and when asked he has to check his underpants before he can say. [Mrs 12] describes [Child 12’s] motions as normal, but the soiling as very loose.”

She then goes on to describe Child 12:

“[Child 12] has his bowels open, the smell is often very strong and offensive.

Looking back over [Child 12’s] medical history, given by [Mrs 12], he has had regular bouts of sickness and diarrhoea with a high temperature.”

Just pausing there, that clearly was a history that the mother had given to Helen Hopkins, but would that accord with your understanding of Child 12’s problems at the time?
A I was not aware of some of the symptoms that are described there. The child was not being brought into the surgery regularly to discuss those symptoms, so my understanding is she was coping with it at home. We do not have any records of illnesses when the child had a high temperature.

Q I think you have told us already that this child was sometimes being dealt with by community doctors. Is that right?
A Yes.

Q If we go on to see the purpose behind this letter, if we look in the next paragraph, a few lines down she writes:

“I feel it is possible that [Child 12’s] soiling is part of a psychological/behavioural problem that will be further assessed through …”,

and then there is a reference to a place where it could be assessed, but then asks this:

“I wondered if you would be able to assess [Child 12’s] soiling from the medical point before I pursue my side.”

So, effectively this is an invitation for you to make an assessment of the child to see if there is a medical cause that you can identify?
A Yes.

Q Can we then see how you deal with this matter, please, and turn to page 131? Do we there see a letter that you write back to Miss Hopkins, dated 10 April 1996?
A Yes.

Q Obviously, you are referring to that letter we have just looked at and you write:

“I saw him this week with his mum. On examination there is no evidence of any abdominal abnormality and rectal examination revealed an empty rectum.”

Let us just pause there. Presumably, this means that you carried out a physical examination of the abdomen?
A Yes.

Q As well as an internal examination of the rectum?
A It would appear so, yes.

Q And the purpose in doing that?
A To establish whether he was impacted with constipation.

Q You go on to say:

“It would appear, therefore, that [Child 12] does not have a significant constipation problem and I feel he should be referred back to the MacKeith Centre as outlined in your letter.”

A Yes.

Q So from your assessment at that point in your opinion this child did not have a significant constipation problem to account for the symptoms that had been described to you in Miss Hopkins’s letter?
A Yes, that is right.

MR HOPKINS: Thank you very much.

THE CHAIRMAN: Ms Smith, is there any re-examination?

MS SMITH: No, thank you, sir.

Questioned by THE PANEL

THE CHAIRMAN: Dr Stuart, there may be some questions from the Panel members now, and if they have any then I will introduce them to you. Ms Golding is a lay member.

A Hello.

Q I have just got a couple of questions . If we look at page 126 of the GP records, the letter here says:

“It will be necessary for me to discuss the nature of the referral with your GP.”

When you had a discussion with Dr Wakefield, what was the nature of the referral? Did he discuss that with you?
A The nature? I am not sure quite what you mean, “the nature of the referral.”

Q I am not sure what that means either. This is why I am asking whether you had an idea of what the nature of the referral would be?
A No.

Q When you spoke with Child 12’s mother when she came to you and told you about this study, did you get the impression that it was a new study or it was an ongoing situation?
A I am not sure. I was unaware of it and she came and told me that she had gleaned some information. I do not recall where she had heard it from, but she had information and she was quite clearly keen for her son to be investigated.

Q So when you made the referral did you believe it was to investigate whether the child was suitable for the study or whether he was actually going on to the study? So, therefore, if he was not suitable, then he would not go on it?
A Yes, I think my understanding was that the referral was for an initial assessment for suitability.

MS GOLDING: Thank you very much.

THE CHAIRMAN: Dr Stuart, can you just open page 11 of your GP notes? I think you have been asked questions on this call from Dr Wakefield, the consultation of 30 July 1996?
A Yes

Q Can I just ask you a question because I was not quite clear with the answer that you gave to Mr Coonan. I think you said something first and then I think you said something different, to my understanding, but I just want to have the correct answer.
A Okay.

Q The document that you refer to that was accompanying – well, that actually came either before or after the call, I think your first answer that I understood was that the call followed the document.
A No.

Q But your subsequent, my understanding was, when Mr Coonan was talking to you, that actually the document followed the call.
A That is correct.

Q That is correct, right. Thank you. Following that, the next telephone call took place on 23 September and that is on page 124.
A Yes, that is correct.

MR COONAN: I am not sure there is a reference to a telephone call on page 124.

THE WITNESS: In the letter.

THE CHAIRMAN: Actually it does say:

“…who we have discussed on the phone.”

MR COONAN: Yes, but what you said was “another telephone call.” That was the basis of the question.

THE CHAIRMAN: That is what I want to actually clear. I am sorry, not another call, there is a reference to another telephone call – a reference to a telephone call on page 124.
A That was the same telephone call.

Q It was the same telephone call. There was no other telephone call?
A No. The child’s mother informed me I would receive a telephone call. I had one telephone call and the documentation to explain about the study followed in the post.

Q The telephone call that is mentioned on page 124, it is obviously the same now we have clarified. I was not absolutely sure whether that call from was from Dr Wakefield or Professor Walker-Smith because there are two names mentioned but you have clarified that. Again the word that you have mentioned is “recently”.
A There was definitely one telephone call.

Q If that is the answer, I am quite happy with that. There is nothing you wish to add?
A No.

THE CHAIRMAN: I have an indication there are no further questions. Any questions
Ms Smith?


THE CHAIRMAN: Are there any further questions? (No further questions)

Can I thank you, on behalf of the Panel, and you are now released.

(The witness withdrew)

MS SMITH: We have no other witnesses for today.

THE CHAIRMAN: We will now adjourn and resume tomorrow morning. Would it be possible for you to give some idea how many witnesses are coming tomorrow?

MS SMITH: One witness, Dr Pegg , the chairman of the ethics committee. I am anticipating he will take the day so he will be the only witness for tomorrow.

THE CHAIRMAN: We will now adjourn and resume at 9.30 am tomorrow morning.

(The Panel adjourned until 9.30 a.m. on Wednesday, 25 July 2007)

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