Tuesday, January 31, 2012

Day 14 GMC Fitness to Practice hearing for Andrew Wakefield



Thursday 2 August 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


Examined by MS SMITH 1
Cross-examined by MR MILLER 6
Cross-examined by MR HOPKINS 9
Re-examined by MS SMITH 12
Questioned by THE PANEL 12


Examined by MR HOMAS 13
Cross-examined by MR MILLER 25
Re-examined by MR THOMAS 33
Questioned by THE PANEL 34


Examined by MS SMITH 40
Cross-examined by MR MILLER 62
Cross-examined by MR HOPKINS 72
Re-examined by MS SMITH 77

THE CHAIRMAN: Good morning, everyone. May I give everyone the usual reminder that mobile phones are switched off? Ms Smith, we had finished with Dr Berelowitz yesterday.

MS SMITH: Yes, sir. The next witness I propose to call is Professor Hodgson.

Examined by MS SMITH

(Introductions having been made by the Chairman)

Q Good morning, Professor Hodgson. Could you start off, please, by telling the Panel your full name and address?
A I am Humphrey Julian Francis Hodgson. My home address is XXX.

Q As far as your position is concerned, I think it is right that you are employed now by University College London as Professor of Medicine and you have held that post since 1999. Is that correct?
A Correct.

Q Since 2001, you have acted as Vice-Dean and Campus Director for the Faculty of Biomedical Sciences based at the Hampstead site of UCL?
A Correct.

Q You have been asked to come along today to provide some evidence relating to the documents which are now in UCL’s possession which were relevant to Dr Wakefield’s terms of employment.
A Correct.

Q Have you been given the opportunity previously when you made your statement to review those documents?
A I reviewed them at the time, yes.

Q I think save for one, they in fact predate your time of employment at University College London.
A Correct.

Q Can we, just so the Panel are clear, explain the involvement of University College? Is it the case that the Royal Free Hospital School of Medicine, the medical school, merged with UCL in 1998?
A Correct.

Q Can you tell us what happened to the personnel records which had previously been held by the School of Medicine?
A It is my understanding that they were transferred into the care of UCL.

Q I want to take you through the documents which I think it is right formed Dr Wakefield’s personnel file which is now held by UCL. If we go to bundle 1, FTP1, page 16, is this a letter dated 10 December 1992? Unfortunately, the second page of it was missing in the original file, which is why it has not been photocopied in this bundle, but if we look at the first paragraph, you will see:

“Dear Mr Wakefield

I have pleasure in writing to offer you an appointment as Senior Lecturer in the University Department of Medicine & Histopathology at this School from 1 January 1993. The appointment carried with it the honorary status of Senior Registrar for which I have applied to North East Thames Regional Health Authority.”

The remainder of the letter deals with the terms of the contrary and the salary.
A Correct.

Q If you could then go on, please, to page 40, this is a document with Mr Wakefield’s name at the top:

“Senior Lecturer in Medicine and Histopathology and Research Director of the Inflammatory Bowel Disease Study Group Royal Free Hospital School of Medicine

Honorary Consultant in Experimental Gastroenterology with zero clinical sessions Royal Free Hampstead NHS Trust”

Then we see:

“Mr Wakefield is the Research Director of the Inflammatory Bowel Disease Study Group, involved exclusively with laboratory-based research. His job entails being Chairman and Research Director of the Inflammatory Bowel Disease Study Group at the Royal Free Hospital School of Medicine. The Inflammatory Bowel Disease Study Group is a collaborative research effort involving some 50 clinicians and scientists based at the Royal Free Hospital and worldwide. The post involves developing both long-term research strategies for the investigation of ulcerative colitis and Crohn’s disease and non-steroidal enteropathy, combined with the day to day running and supervision of research projects involving two PhD students, four MD students and one MS student. Mr Wakefield is also in charge of the day to day activities of a number of graduate scientists working with the group. In addition, the job involves raising funds for the group from Government-run bodies, research-based charities and other Government departments. The overall aim of the job is to provide leadership and strategic research initiatives that will make the Royal Free Hampstead NHS Trust and Royal Free Hospital School of Medicine the World Leader in inflammatory bowel disease research. His research involves the laboratory investigation of resected human tissues, but he will not be involved either in the clinical management of patients with inflammatory bowel disease or the routine histopathological reporting of tissues from these patients. He will not be involved in the out-patient or in-patient management of patients in the Royal Free Hampstead NHS Trust. He will not practise as a Consultant Surgeon, Physician or Gastroenterologist as part of this appointment.”

Then we see at the bottom a daily timetable which involves research on every day of the week and, in addition to that, one Gut Club meeting and a Grand Round meeting, but other than that, as I say, research both morning and afternoon. Is that correct?
A Yes.

Q If we look at the top left-hand corner, do we see that was approved on 22 November 1992?
A Correct.

Q Then if I can just take you on, Professor. I am sorry. I read it out as 1992, but in fact it is 1993, it has been pointed out to me.
A I think it is ambiguous.

Q Yes. As far as that document is concerned, can you tell us what conclusions we can draw from it? What does it appear to you to be?
A It appears to me to be a statement of Mr Wakefield’s role in the medical school, which was as the leader of a group in laboratory based research, but not involved in the clinical management of patients.

Q From the fact that it was in his personnel file, can we draw any assumption as to whether it was regarded as being relevant to his employment?
A I think it is a fair assumption that it was.

Q If you would then go on to page 44, please. This is a letter from John Cooper, who was the then Chief Executive of the Royal Free Hampstead NHS Trust dated 21 January 1994. We see it says:

“Dear Mr Wakefield,

I am directed by the Royal Free Hampstead NHS Trust to offer you an appointment as Honorary Consultant in Experimental Gastroenterology at the Royal Free Hospital with effect from 1st January 1994 linked to your paid employment with the Royal Free Hospital School of Medicine.

The terms and conditions … are those of the Royal Free Hampstead NHS Trust …”

He is required to be the member of a professional defence organisation and to be registered with the GMC. Then we see the words:

“No specific clinical sessions are designated under the terms of this honorary appointment.”

Turning over, we see that the document has been signed by Dr Wakefield on 1 February 1994, accepting the terms and conditions set out in the letter, and indicating that he is a member of the Medical Protection Society.

Can we go on, please, to page 87. This is a long letter and, in effect, a reference from a gentleman called Leon Fine, addressed to Professor Zuckerman, the Dean of the Royal Free. I do not propose to read out the whole of the letter. Mr Coonan may wish to do so, but we see at the start:

“I wish to propose the promotion of Dr A.J. Wakefield to Reader in Gastroenterology.”

If we look to the end of the letter on page 89:

“Dr Wakefield has no current clinical responsibilities. His presence in the Division of Gastroenterology in the Joint Department of Medicine has galvanised a considerable amount of clinical research and his ongoing collaboration with Prof R. Pounder has always been a productive one.

I recommend his promotion to Readership with enthusiasm and conviction.”

Could we turn on, if you please, to 314, we see that reflected in a letter from the Assistant Secretary, Miss Lewis, on 14 November 1996.

“Dear Mr Wakefield,

I am writing on behalf of the School Council and on the recommendation of Professor Pounder and Professor Revell to offer you renewal of your appointment as Senior Lecturer in the Departments of Medicine & Histopathology on a permanent basis from 1 January 1997.

The appointment, which carries with it the honorary status of Consultant at the Royal Free Hospital, will terminate at the end of the University session in which you attain the age of 65 years.”

Then, going on down to the penultimate paragraph:

“Your appointment is made on the condition that you hold, and continue to hold, an Honorary NHS contract at a designated hospital. The holding of an Honorary NHS contract is essential to the proper performance of your clinical teaching duties.”

Then we see on the next page, 315:

“Clinical Senior Lecturers may perform private clinical practice on the following conditions:”

Then there are a set of conditions which I will not read out which apply to the performance of private practice. Can you explain, Professor, how that document with the reference to private practice fits in with the documents I have already taken you to, which all emphasise the lack of any clinical commitment?
A My interpretation of that was that this document had probably been prepared from a pro forma and that this was attached to the pro forma and would be a routine part of any contract issued to a clinical academic by the medical school. That was my view when asked to formulate my thoughts about that. On the other hand, as qualified medical practitioner, presumably had Mr Wakefield wished to pursue private practice this would delineate the circumstances under which it would be done.

Q But as far as the restrictions that were put on his clinical practice to which we have already referred, would that be affected at all by this provision in relation to private practice?
A I do not think it would.

Q Are there any particular reasons why you would not consider this to be relevant to Dr Wakefield’s case?
A The page 2, I do not think, is relevant to the critical issues of whether his employment by the medical school and his honorary contract by the Trust which, as I have already agreed with you, indicated that he was not involved in clinical practice and I do not think this outweighs that in any way.

Q If I can just for the sake of completeness take you on to one document which is in your FTP bundle 2, which is at 427A. This is a letter from Miss Lewis, 21 April 1997, simply confirming Mr Wakefield’s promotion to Reader?
A That is correct, yes.

Q Would you now go to the third of the FTP bundles, please, at page 1140. This is a document that has to be added to the Panel’s bundles. I am not sure if you have it not, Professor.
A I have 1140a and I have 1139.

Q Then we must hand you one as well. (Page 1140 distributed) This is a letter to Sarah Brant. I think it is right that she is a director of human resources at UCL, is that correct?
A Correct.

Q It is from a Dr Bill Stephenson, who is said on the actual email to be the Admissions Tutor, but was he fulfilling a particular role in this context, do you know?
A I have no idea, I am afraid.

Q Do you know who he is?
A My only awareness of Dr Stephenson is from this piece of paper.

Q Right, and you do not have any recollection as to why he would be writing to the personnel director in relation to Dr Wakefield?
A It would be pure surmise.

Q I will not ask you to surmise. We see the terms of it:

“Dear Sarah

1. Andy is happy with idea of a formal collaboration agreement with Simon Murch and thinks this should be possible.

2. He has an Honorary Non-clinical Contract with the Royal Free and does not think this is a big deal.”

Then it provides details as to his email address. Can I ask you, Professor, generally speaking – and will you remember there are lay members on this Panel, as well as medical members – is there any inherent contradiction between being employed as a clinical academic with an honorary consultant NHS contract and a job description which explicitly excludes clinical work?
A No, there is not an inherent contradiction between the two. I can see that in verbal terms it does sound somewhat paradoxical but within medical schools there are clearly academics who work as clinicians looking after patients; there are also academics whose work has nothing whatever to do with individual patients, but nonetheless is in the general field of human medicine. The honorary contract status confers to any employee of a medical school a status and a protection to the hospital within which they work, that that individual has the ability – I think the most obvious one is – to conduct clinical teaching rounds; to be in the privileged position of seeing and participating in conferences about patients and so on. Thus to have someone who is not clinically engaged, but has an honorary clinical contract, is really quite straightforward.

MS SMITH: Thank you very much, Professor. If you stay there you will be asked some questions.

THE CHAIRMAN: Professor Hodgson, as I did say earlier, counsel for the three practitioners would now be entitled to cross-examine you. Mr Coonan is here on behalf of Dr Wakefield.

MR COONAN: Sir, I do not have any questions for Professor Hodgson, but could I invite the Panel to save time – Ms Smith indicated this – the document at bundle 1, page 87 which is a long letter. She did not take you through it but just took you to the end on page 89. Could I invite the Panel, please, in their own time to read that. It seems a waste of time for me to use the Professor, with his valuable time, to read the whole document into the transcript. I am therefore inviting you, please, as a Panel to read that yourselves.

THE CHAIRMAN: Indeed. Thank you very much indeed, Mr Coonan. So there are no more questions from you?


THE CHAIRMAN: Mr Miller on behalf of Professor Walker-Smith.

Cross-examined by MR MILLER

Q I am going to ask you about different things. I am not going to ask you anything about the contractual status of Dr Wakefield. Part of your medical expertise is in gastroenterology, is it not, although your specialty is haematology?
A That is correct, yes.

Q You were the author of the Royal Free statement which the Panel has in FTP3 at page 1215?
A Yes.

Q I come back to the text at the end, but we see your name at the bottom of it and your position at the Royal Free and University College School of Medicine. I think you were wearing, as it were, two hats at the time that you made that statement because you were making it on behalf of both the Royal Free and University College School of Medicine and the Royal Free Hampstead NHS Trust?
A Correct.

Q And the statement followed, I think, an all day session – not really a meeting but an all day session – on the 18 February 2004 at the Royal Free generally in the sense of paediatric gastroenterology?
A It was not all day, but there was a meeting. I assume the date is correct, yes.

Q An afternoon?
A Yes.

Q I think probably not all day. It was afternoon, going on to early evening, and then as a consequence of that a number of statements were prepared. You were preparing one on behalf of the Royal Free, but also Professor Walker-Smith and Professor Murch also prepared statements?
A Correct.

Q By that stage in February 2004, of course Professor Walker-Smith had been retired for three and a half years or so. I think he retired in October 2000, although he still had emeritus status at the University College Medical School?
A Correct.

Q The meeting had various aspects to it, and I think individual doctors who had been involved in The Lancet paper dealt with different aspects which had to be aired through The Lancet or it was intended would be aired through The Lancet. They were particularly Professor Walker Smith, Dr Murch and Dr Mike Thompson, consultant paediatric gastroenterologist who was there as well.
A My recollection is that that is so, yes.

Q Dr Horton from The Lancet was also there at the Royal Free for some part of the time. Is that correct?
A Correct.

Q Dr Wakefield was not there?
A He was not.

Q One of the tasks was to go through the case notes of the individual children whose cases had been written up in The Lancet. I believe that was something which Dr Thompson did physically, but you were involved in that as well. Is that right?
A My recollection is that it was he who went through the notes, yes.

Q One of the points that he was looking for was to identify the method of referral in each case as how these patients had got to the Royal Free.
A As far as I concerned, that was the particular reason that that was being done at the time, yes.

Q The notes were there, he went through them and that was what he was concentrating on?
A Yes.

Q Dr Murch was looking at the paperwork of the ethical side of things and the application that had been made for ethical approval for what we have been told is 172/96, the original concept, and documentation surrounding that application and following it?
A He was concerned with, I believe it is correct, preparing the statement which I imagine appears elsewhere in this bundle under his name.

Q It is about two pages further back.
A Yes. That was what he was particularly concerned with during that evening.

Q Professor Walker Smith was also preparing his statement, which again all gets published at the same time ultimately, but they were all being done at the same time?
A Whilst I can recall what Dr Murch and Dr Thompson were doing, I cannot in fact recall what Dr Professor Walker Smith was doing.

Q He will tell the Committee in due course that he was dealing there with his statement. There were discussions about what was going to be said - not as far as you were concerned, you prepared your statement on your own - as far the other two were concerned there was some discussion as to the content of those statements with you and with Dr Horton, the editor of The Lancet?
A There was certainly general discussion, yes.

Q As I say, you had the particular task, obviously knowing what was going on, you had to prepare the statement that you were going to make on behalf of the Royal Free, the medicine school and the Trust, and at the end of the exercise in the evening of that day, presumably you were satisfied that the children had been referred by a proper clinical pathway and that the investigations were clinically justified and thought appropriate in the light of the children’s symptoms?
A Yes, that is correct.

Q If we look at the text of the statement which you made on behalf of the Royal Free at page 1215, you say:

*“We are entirely satisfied that the investigations performed on the children reported in The Lancet paper have been subjected to appropriate and rigorous ethical scrutiny. Because the nature of the condition affecting child behaviour and gastroenterological symptoms was unknown and required elucidation, the investigation of these children was properly submitted to and fully discussed by the Ethical Practices Committee at the Royal Free Hampstead in 1996. Specifically that Committee was a sub committee of the then Camden and Islington Health Authority Research Ethics Committee subsequently incorporated to the new central office for research committee arrangements those decisions were independent of the university and the hospital”.

From what had been gleaned from the documentation, presumably you had satisfied yourself about that?
A Correct.

* “The Committee, after clarifying a number of issues, including that the children’s investigations were defined by the clinical symptomtology and diagnostics requirements and having taken expert advice approved the protocols submitted”.

Again, presumably you satisfied yourself of that?
A Correct.

* “The clinical management and investigation of these children was performed at the Free by a dedicated team of consultant paediatric gastroenterologists in full consultation with an agreement of the parents of the affected children that the investigations were those thought appropriate in the light of the severity of the children’s symptoms according to the clinician’s judgment at the time”.

* Document not available to shorthand writer

Again, presumably, you satisfied yourself of that?
A Correct.

Q Those were the issues which affected the clinicians, those who were there at that meeting, as to how the children had been referred to the hospital and how they had been investigated?
A Correct.

MR MILLER: Thank you, Professor.

THE CHAIRMAN: Thank you Mr Miller. Mr Hopkins?

Cross examined by MR HOPKINS

Q Professor, I just want to deal with the same meeting and the points arising from it that Mr Miller has just been asking you about. If we can stop in the bundle that you have open and go back to page 1212, please, and on the right hand column we see a statement by Dr Murch.
A My bundle goes from page 1210 to page 1213.

THE CHAIRMAN: That is right. In my bundle it is page 1210 as well and then there is page 1213.

THE WITNESS: I think I have the latter half of Simon Murch’s on page 1213.

MS SMITH: We will now re insert that document.

MR HOPKINS: We will have to pause while that is done.

THE CHAIRMAN: Can I just make sure with the Legal Assessor that it is appropriate for this document to go in now?


THE CHAIRMAN: Can I check with you, Ms Smith, the page that we now have is page 1212, so page 1211 is still missing out of the bundle?

MS SMITH: That was another document that Mr Coonan had objected to and we will now put that back into the bundle as well.

THE LEGAL ASSESSOR: Ms Smith, you are referring to them as separate documents. I have all these pages and they all seem to be a continuation of the same document to me.

MS SMITH: They are indeed. I will not complicate matters. There is a degree of duplication simply because of the photocopying of The Lancet, but you are quite correct in this context.

MR HOPKINS: If we can then look at page 1212 in the right hand column we see a statement by Dr Murch and then set out below what that statement consists of. I just want to deal with the context of this for the moment. If we look at the opening sentence, it deals does it not with allegations that are being made that need to be addressed?
A Correct.

Q Just by way of background is the position this: before the meeting that you just been telling us about, allegations had been put by a journalist, Mr Deer, and brought to the attention if Dr Horton at The Lancet?
A Correct.

Q As a result of that, there had been a meeting with Dr Horton by some of the authors of the 1998 Lancet paper.
A Correct.

Q As a result of that it was decided to involve you and have the meeting with you on 19 February at the Royal Free.
A I think the chronology of exactly what order the meetings were held in may not be correct, but I had met Dr Horton on a one to one basis in addition to a general meeting.

THE CHAIRMAN: Sorry, can you keep your voice level a little bit up?

A I am not sure the chronology is entirely correct. I had met Dr Horton on a one to one basis before that evening meeting and we had also met together with the paediatricians.

Q On 19 February, the meeting was convened as you have been asked about by Mr Miller to start dealing with the allegations that had been raised?
A Correct.

Q Is it right to say that for the initial part of that meeting there was a problem in identifying the patient names and, therefore, accessing the records of the patients because they had been anonymised in The Lancet article?
A I had no recollection about that form of detail I am afraid.

Q Let me pose it another way. Do you recall it took a while, a few hours before the medical records for the individual patients could be accessed?
A Yes, but unless those records had been kept in an isolated place I would anticipate that they would have been in the general hospital medical store and, if I may say so, I was somewhat impressed that they could all be recalled and brought to the same desk within the course of a relatively small number of hours.

Q What I am suggesting is that those records first became available round about 5 o'clock in the evening of that day?
A I would agree with that, yes.

Q Once they were available, as you describe, Dr Thompson went through them, but also Dr Murch, as he then was, looked at some of these records too. Does that fit with your recollection?
A Yes.

Q Having gone through those records, at approximately 9 o'clock that evening is it right that you then asked Dr Murch to deal with some of the allegations that had been raised by the journalist?
A We were faced with, as members of the Panel may or may not be aware, the likelihood that there was, within a short space of time, going to be an article published by this journalist, which certainly contained allegations which we wished to have reviewed. If they were inappropriate allegations we wished to state our position and we wished to state our position first. There was, therefore, a discussion about the appropriate way to achieve that position, and part of that was to deal with the allegations that we believe we were going to put forward, which we felt that we could take a position on and what was the most appropriate way to put that position forward. There was, I believe, no disagreement that the final outcome, which was these four positions put forward by the editor said, Professor Walker Smith, Dr Simon Murch and myself, I do not think there was any disagreement that that was the appropriate way to go forward.

Q I am not suggesting that at all. I am just interested in the timescale. What I am suggesting is that the notes become available around about 5 o'clock, it takes a while to go through them and it is not until 9 o'clock that Dr Murch is then tasked with dealing with some of those allegations. That is all I am concerned with, the time.
A I suppose the reason why I gave a somewhat round about answer is that I do not precisely recollect at what time it was thought that Dr Murch should, would be charged with making his comments.

Q Can I put it another way round. Would you disagree with the timescales I have just put to you?
A I suppose I can neither agree nor disagree because I have no clear recollection of exactly when those decisions were made.

Q That is sufficient for my purpose. The overall timescale, as I think you have already hinted at, was to get out this response as soon as possible and the intention being it should be with the Lancet by 10.30 the next morning. Is that right?
A That seems reasonable. I cannot remember the exact time, but that seems reasonable.

Q Therefore, the response that we see set out at page 1212 and over the page by Dr Murch was, in effect, prepared overnight?
A It was certainly prepared within a fairly short space of time and seeking back into my mind I believe that when I came in next morning it was on my screen.

Q That was the next thing I was going to put to you. You were shown a copy of the draft that Dr Murch had prepared overnight.
A Yes.

MR HOPKINS: Thank you very much.

Re examined by MS SMITH

MS SMITH: Just a couple of matters, Professor, arising out of the answers that you gave to Mr Miller, who is the representative for Professor Walker Smith in the middle. He asked you whether you, at the end of the exercise that you carried out, were satisfied that the children had been referred by a proper clinical pathway and that they were investigated appropriately in the light of their symptoms. I wanted to ask you in relation to that, first of all as far as the referral process was concerned, what information did you have in relation to that process?
A It is my recollection that there was within the notes of each patient a referral letter from a medical practitioner.

Q As far as the investigation of the children in the light of their symptoms, can you tell us did you exercise, yourself, any independent judgment in relation to the clinical indications or were you reliant on the representations of the clinicians involved?
A I was relying on the representations of the clinicians involved. I do not think it would have been appropriate and it certainly would have taken a longer period of time than I had available. Furthermore, I am not a paediatrician gastroenterologist. I do not think I would either have volunteered or acquiesced in the suggestion that I should make individual clinical judgments.

Q If I can just look back at the statement from the Royal Free, which it at page 1215. If we look at the penultimate paragraph you say the investigations, i.e. the clinical investigations were those thought appropriate in the light of the severity of the children's symptoms according to the clinician's judgment at the time?
A Correct.

Q Were you comfortable with making that statement?
A In as much as the information that I had and the papers that I had seen contained statements from respected paediatric physicians saying that they believed, who were looking at the patients saying that they believed that those were appropriate, I thought I was happy making that statement otherwise I would not have made it.

MISS SMITH: Thank you very much indeed. Thank you, Professor. I have no further questions, but the Panel may have some for you.

Questioned by THE PANEL

THE CHAIRMAN: As I said earlier, if there are any questions from the Panel members I will introduce them to you. Ms Golding is a lay member.

MS GOLDING: Actually, this is not a question to Dr Hodgson, but a matter of clarification. We were taken to page 40 where it says “approved 22/11/92, 93”. I am not sure what was approved in this. Page 40 on F2.1.
A Is that a question to me?

THE CHAIRMAN: Yes. I was just going to ask you: are you in a position to say anything to clarify the question that Ms Golding has posed?
A My surmise would be that this job description had been approved by the directors of, and I think we have had them mentioned elsewhere, but the director of the Department of Medicine and Pathology, and that this meant that the Medical School was happy and accepted this as being the job description, but that is my surmise.

Q Can I just ask you, and you may not be in a position to answer this: the date, you said that it is a bit ambiguous, we do not know whether it is 1992 or 93, right in the left hand corner.
A Yes.

Q Would you know who actually wrote this? Is it your handwriting to start with?
A No, it is not my handwriting. I was not employed by the Medical school until 1999. It is not mine.

Q Again, you may not know: do you know whose handwriting it is? If you do not know just say.
A I could not, with any conviction, say whose it is.

THE CHAIRMAN: I think that is fair enough. I do not think the Panel Members have any questions, but the Council can have another bite of the cherry if they want to. Ms Smith, first of all.

MS SMITH: No, I do not want another bite.

THE CHAIRMAN: Mr Coonan, Mr Miller, Mr Hopkins? No. Can I thank you on behalf of this Panel, Professor Hodgson and say that you are now released. Thank you for coming this morning.
A Thank you for your courtesy.

(The witness withdrew)

MS SMITH: Sir, the next witness we are getting is Mr Kirrage and Mr Thomas will deal with him. The records you are going to need are for child JS. There are four volumes, in fact, of JS records.

THE CHAIRMAN: Are we going to need all records?

MR THOMAS: You will need the first volume of the local hospital records and the Royal Free records. Right at the end you need not take it out now, you will need the GP records.

Examined by MR THOMAS

(Introductions having been made by the Chairman)

Q In fact, you will be disappointed to know it will be me who take you through your evidence. Could I ask you to state your full name and professional address?
A My name is Dr David Christopher Kirrage. My professional address is as director of the West Midlands West Health Protection Unit based in Worcester.

THE CHAIRMAN: I think maybe your voice is very soft, but can you pull the microphone a little closer to you and hopefully it will get a little better?

A Dr David Christopher Kirrage. My address is as director of the West Midlands West Health Protection Unit based in Worcester.

MR THOMAS: Thank you. Dr Kirrage, you are being asked to give evidence this morning in relation to one particular patient. If you look on the table in front of you there should be a laminated sheet that contains anonymised information. Could you confirm on that sheet that the patient that you are being asked to give evidence about is JS?
A That is correct.

Q In your evidence, if you do need to refer to the patient by name we would be grateful if you could refer to him as “JS” and we will try to do the same. There are restrictions in place to prevent his identity becoming public in any event, so do not concern yourself too much if you slip up. You have already stated that you are currently employed by the Health Protection Agency as Director of the West Midlands Health Protection Unit. Could you tell the Panel what your position was in 1997?
A In 1997, I was employed as a consultant in public health medicine with Worcestershire Health Authority.

Q What were your responsibilities in that post?
A Among the responsibilities I had were the responsibilities for providing a medical input into decisions regarding extra-contractual referral requests as well as general public health medicine duties, which covered quite a range of responsibilities.

Q Could you explain your role within the system of extra-contractual referrals at that time?
A At the time, the health authority purchased care for residents of Worcestershire and these were mainly set up through contracts with local hospital providers, plus regional specialist units and in some case national specialist units. Where a patient was referred outside of these contracts, the reason for referral was reviewed by an administration team and there were any points that required clarification or a decision needed to be made which required medical input, they would be referred to myself.

Q In this case, have you had an opportunity to review the relevant correspondence and records in relation to the seeking of an extra contractual referral in respect of JS?
A Yes, I have.

Q Can I ask you to turn to the local hospital records, LHR1 at page 210? Do you have that?
A Yes, I do.

Q This is a letter dated 5 July 1997 from the mother of JS and it is to Dr Mills. Could you just help the Panel with who Dr Mills was?
A Dr Mills was a consultant community paediatrician based in Worcester, looking after Worcestershire patients.

Q What role did he have in relation to JS?
A My understanding was that he had been responsible for part of his care and throughout JS’s life.

Q This letter was copied to Dr Wakefield and then we have in manuscript, “Please copy to David Kirrage, Public Health Doctor”. Do you know who wrote that?
A I do not. I assume it was Dr Mills.

Q It is from the mother of JS and it says:

“Dear Dr Mills

Enclosed is a copy of a letter I have today sent to Dr Wakefield. I am so sorry you feel you are unable to make a referral for JS.

I appreciate it is a difficult decision for you but I feel sure that when such a totally life destroying occurrence has happened to what was a normal, very happy and communicative little boy, any parent would want to look further.”

If you would turn back to page 209, you will see the letter which JS’s mother wrote to Dr Wakefield. This is also dated 5 July. She says:

“Dear Dr Wakefield

I am writing to ask if you could please refer my son, JS, for tests to see if there is any way he can be helped following the devastating damage caused by his MMR injection in 1992.

As you know he is presently a weekly boarder in an autistic unit ….”

And she gives the name of the school –

“His care assistant has noticed he seems to become very agitated before a bowel movement and that he appears to experience some pain or discomfort.

He has a history of diarrhoea – although his stools are more normal now. As he has no communication we cannot tell where his discomfort lies. It is very difficult to know if JS is in pain because he is so active – to the extent of him now scaling a 7ft fence in order to escape.”

Then it describes an incident which had occurred a couple of weeks earlier.

“The whole issue of his security is causing us much worry.

I would very much like to be referred to you as during my last appointment with doctors here it was made very clear that there is nothing they can do to help him medically bar seeing a psychiatrist for drugs and keeping him in an autistic unit.

I feel my doctors do not believe that JS has been damaged by the vaccination – in spite of the fact that he was a perfectly normal baby, and a bright, affectionate and highly verbal toddler. And in spite of the fact that the vaccine he was given was later withdrawn by the government because it carried a high risk of adverse side effects.

My husband and I feel we must explore every possibility to help our son. As it is now JS has no future at all – other than being sedated and confined in an institution.

I look forward to hearing from you soon.”

Do you know why this letter was brought to your attention, Dr Kirrage?
A I believe, or to the best of my knowledge there may well have been some discussions between Dr Mills and the mother of JS requesting a referral which this letter was part of and therefore to give myself some facts, that letter was then copied to me.

Q It appears from JS’s mother’s letter of 5 July that Dr Mills felt unable to make a referral. Is that something you discussed with him at all?
A Yes. I would have discussed it with Dr Mills and took the view that sometimes when you have a health practitioner caring for a patient, it can be difficult because of the patient/practitioner relationship. It is sometimes helpful actually if the decision is made in some cases by somebody remote from that link.

Q What did you ask Dr Mills to provide you with?
A I would have obviously seen the letter from the mother of JS and would have requested a detailed clinical history of JS, which would have taken into account the investigations, treatment and so on.

Q What was Dr Mills’ view as to the appropriateness of the referral?
A I think he felt that the benefits to JS were not likely to outweigh the necessity of travelling to the Royal Free and it was unclear how JS would benefit.

Q Did you yourself draw any conclusions as to the risks and benefits of that proposed referral?
A Yes. I looked at the history and from my own experience in general practice, I could not see, with a child who had a history of agitated behaviour and some special needs that this would actually benefit a trip to London. I felt that if an investigation was deemed to be necessary, it could be undertaken locally to prevent any distress that a journey out of the normal environment might cause.

Q Did you understand what particular investigations would be performed were JS to be referred to the Royal Free?
A My understanding was that it would be a colonoscopy with possible biopsy.

Q How did you view that in the light of your judgment as to his behavioural condition?
A I believed that such a procedure would require a general anaesthetic and I was concerned about the small but significant risk that such a general anaesthetic might have. I could not see that an investigation would necessarily produce a treatment that would benefit the patient.

Q As far as you can recall, did you bear in mind any other factors in arriving at the judgment you have just outlined?
A Yes. There were a number of factors, notably the wishes of the mother of JS, the evidence of a link between the assumption by JS’s mother that JS’s behaviour and condition was caused by the MMR injection and any evidence that an investigation would be founded on a plausible link to MMR and the likelihood that that would result in a treatment that would help JS.

Q Before I take you to a letter which you drafted on this subject, did you speak to anyone else apart from Dr Mills before arriving at that judgment?
A I do not recall – well, I did speak to a specialist in the MMR vaccination, Dr Elizabeth Miller. I cannot recall if I spoke to JS’s GP or not.

Q Can I now take you to page 211 in the same bundle? This appears to be a letter dated 21 July 1997 to JS’s mother. If you look on page 212, you will see that it is signed by you. Is that your signature?
A Yes.

Q If I can ask you, before we look at this letter, to look at page 213. This is a manuscript document dated 21 July 1997. Can you help us with who wrote it?
A Yes. I wrote the letter.

Q It says, “Dear Andy”. Who is Andy?
A That is Dr Mills.

Q You say:

“Re JS

I have drafted a letter to Mrs JS which I think sums up the public health view. I would like you to see it before it I sent in case it does more harm than good.

I feel that you are entirely right in the line you have taken. There is no evidence that this will benefit JS and a literature search has not added anything new. I appreciate the pressure on yourself and the GP and will support funding the investigation if you feel that in the end this is appropriate. My letter ‘sits on the fence’ and hopefully will enable you to act either way. If you feel that it is not helpful then please bin it.

Best wishes

Are you able to say whether the letter was in fact sent, to your knowledge?
A I believe it was.

Q Let us then look at page 211, the body of the letter to JS’s mother. Before I read it out for the purposes of the transcript, could you tell us what the purpose of this letter was?
A As I saw it, the purpose of the letter was to explain to the mother of JS the reasoning behind our refusal to fund the extra-contractual referral and also partly to protect the doctor/patient relationship between JS, the mother of JS and the clinical team that were treating JS locally.

Q It says:

“I am writing to you in connection with your son JS and the ongoing care provided by your GP and Dr Andrew Mills, Consultant Community Paediatrician.

Dr Mills asked me for an opinion on certain aspects of JS’s care and provided me with the clinical background to JS’s condition together with the correspondence between Professor Walker-Smith and himself. As a Public Health Consultant one of my principle duties is to critically appraise the evidence for various investigations or treatments.

To me there appears to be two main concerns. Firstly, was JS affected by his MMR injection in 1992 in such a way that his present autistic behaviour is a direct result of that vaccination. Secondly, in what way can he be helped in the future, and following on from this, would investigation by Professor Walker-Smith contribute to this.

In considering the link between the MMR vaccine and autism I contacted Dr Elizabeth Miller one of the national experts on vaccination based at the public Health Laboratory Service in London. The possible association between autism and MMR vaccine has been studied in depth both in this country and abroad. The conclusions are that there is no epidemiological or biological evidence to support a causal link. In support of this conclusion I think the following points are relevant:”

Then you summarise four points. You say:

“There are no scientific publications which prove an association between MMR vaccination and autism at the current time.”

Then you deal with a comprehensive review by the American Institute of Medicine and I will not read the entirety of that. Paragraph 2:

“The diagnosis of autism is generally made in the second year of life at around the time when MMR vaccine is given. Associations therefore between this diagnosis and prior MMR vaccination could be expected by chance.

There have been no published studies which suggest an association between wild measles virus infection and autism. Autism has not been reported as a sequel of measles encephalitis. There is therefore little biological evidence to support an association between measles vaccine and autism.

If introduction of MMR vaccine was responsible for an increase in the incidence of autism we would expect to see an increase interest he number of cases from the date at which the MMR vaccine was introduced. Good data on the incidence of autism from a Swedish study shows that this has not been the case.

Moving on to whether investigations at the Royal Free Hospital will establish the diagnosis and indicate a means of treating this, I fee that at the present time there is insufficient evidence to support his. I do acknowledge, however, that there could well be benefit from actively addressing symptoms that some children with autism have experienced. My understanding is that Dr Mills has been very exhaustive in his efforts to ensure that JS was not subjected to unnecessary and uncomfortable tests for gastrointestinal symptoms which he was not experiencing. I think this is entirely appropriate in Dr Mills clinical responsibility to JS.

I fully understand the desire not he part of all concerned to help JS. I think at the moment however there are not strong grounds to indicate referral to the Royal Free Hospital. I note from your letter of the 5th July 1997 that his care assistant at [the school] has noticed that he may be experiencing discomfort before bowel movements. If this was to persist or increase in severity then I would suggest that the indications for possible referral may strengthen the balance in favour of investigation at the Royal Free. I think this is a decision that should be made by those directly involved in this care and that my role is merely to provide an objective evaluation of the indications and benefits of investigation and treatment by the study group under Professor Walker-Smith.”

Can I ask you, Dr Kirrage, does that letter accurately summarise the view you had reached by that stage?
A Yes.

Q Can I ask you now to take up the Royal Free Hospital records bundle at page 16? This is a letter from Rachel Lewis, the Deputy Contracts Manager at the Royal Free to Dr Shore at the Demontfort Medical Centre and it relates to JS. It is dated 23 October 1997 and it says:

“As you know this patient has been attending the Royal Free Hospital for treatment, and the following arrangements have been made for their next visit.”

Then it provides an admission date for a colonoscopy on 12 November 1997 in the paediatric gastroenterology department under Professor Walker-Smith. The letter goes on:

“We do not contract with Worcester Health Authority and therefore we have requested funding for this patient on an Extra-Contractual Referral basis. This funding request has been refused, the Health Authority request that you make arrangements for the patient to be referred to an alternative local provider.

I would be grateful if you advise me if you envisage any difficulties with arranging alternative care by 31 October 1997. Should we not hear from you in this period, we will assume that alternative arrangements have been made and therefore the patient no longer requires the above admission date. We will then undertake to write to the parents informing them that this admission is no longer allocated to them.

Please note that JS was originally seen by Professor Walker-Smith as a private patient but has now transferred to the NHS.”

Dr Kirrage, in the middle of that letter there is a sentence which says that the funding request made by the Royal Free has been refused by the Health Authority. Is that consistent with the position as you understood it in October 1997?
A Yes.

Q Can I ask you now to turn back to the local hospital records and on to page 219. Do you have that page?
A Yes, I do.

Q This is a letter from the Worcestershire Health Authority dated 30 October 1997 from Daniel King, who is described as the ECR manager. What was his particular role?
A He was part of a small team that processed extra-contractual referral requests, so he would be receiving ECR requests from a number of different hospitals across the country.

Q He writes to Miss Lewis, the Deputy Contracts Manager, at the Royal Free, and he says:

“ECR Request: [JS]

Further to my fax I have had the opportunity to discuss this ECR with Dr D Kirrage, Consultant in Public Health Medicine. I enclose a copy of a letter that was sent to JS’s parents from Dr Kirrage back in July 1997. You will see that at that time there was no information available that supported the clinical effectiveness of the proposed treatment. We are not aware that this situation has changed from that time and will therefore not be funding this ECR.

Please do not hesitate to contact me if you have any queries. Please could any clinical correspondence be addressed to Dr David Kirrage, Consultant in Public Health Medicine care of myself.”

This letter refers to a discussion that you had with Mr King, Dr Kirrage. Do you happen to remember that discussion?
A Yes. We met on a virtually daily basis to go through ECR requests that had come in, or were being processed. I would have told Mr King that I did not feel the request should be approved, and he would have written back to that effect to the hospital that had requested the approval.

Q Between the time that you wrote your July letter, and the time of this letter – October 1997 – had you been made aware of any new information?
A Not to my knowledge.

Q Can we now go on to another page, page 15 of the Royal Free Hospital records. This is a letter from Norma Rees, Contracts Manager at the Royal Free, dated 6 November 1997, addressed to Professor Walker-Smith. It is at page 15. Do you have that?
A Yes.

Q Again, it relates to JS. It says:

“As you know we are having some difficulty in securing ECR funding for this patient’s admission The Royal Free Hospital, and the admission date of 12 November 1997 has been cancelled.

I contacted Worcestershire Health Authority earlier today with the information you had given to Cally Palmer regarding the clinical need for this patient to be admitted to this hospital. They have requested that you speak directly with the Consultant in Public Health Medicine (contact details are provided below) on this matter before that will reconsider the ECR request.”

I assume it means that the request will be reconsidered and a conversation needs to take place between you and Professor Walker-Smith. Carrying on with the letter:

“I would be grateful if you could let me know when you have had opportunity to do this so that I may contact the authority for their decision.”

Then your contact details appear below that paragraph. Is that correct?
A That is right.

Q Would you now look in the same bundle at page 11, Dr Kirrage, you will see there a letter from Professor Walker-Smith dated 11 November 1997 to you. It begins:

“Following our telephone conversation concerning JS, I am sending you copies of two abstracts concerning this question of autism (or regressive behavioural disorder) and ileo-caecal lymphoid nodular hyperplasia and non-specific colitis.

In the case described in abstract 31 we describe a response to enteral feeding and mesalazine.

I hope you will agree to his admission on 12th November 1997.”

- that being the following day. It refers to a telephone conversation there between you and Professor Walker-Smith, Dr Kirrage. Do you remember that telephone conversation?
A I do remember it taking place. I do not remember all the details.

Q Could you help us with what was discussed?
A I think I received a call from Professor Walker-Smith and we discussed the reason for Worcestershire Health Authority refusing the extra-contractual referral. My recollection is that Professor Walker-Smith made a strong case for the benefits of such an investigation in terms of finding out the link, if there was a link, between the bowel pathology and the possibility that there could be a link to either MMR or wild measles virus.

Q Do you recall what sort of benefits he attached to that discovery?
A I do not. All I recollect is that the research that was being done, I believe he mentioned it was showing some promising findings.

Q When he described to you the benefits that you have just outlined, were you satisfied in relation to those issues?
A I do not think I was. I think the telephone conversation was left unresolved, but with an agreement to look at some copies of abstracts which were faxed subsequently to myself.

Q If you look at the abstracts which are on pages 12 and 13 of that same bundle, following the letter, can I Dr Andrew Wakefield your attention to 30. I should say that these abstracts appear in the Journal of Paediatric Gastroenterology Nutrition (I assume that is), Vol. 25, Supplement 1, 1997. Abstract No. 30 is titled:

“Ileal lymphoid nodular hyperplasia, non-specific colitis and regressive behavioural disorder: a new syndrome?”

That is authority by, among others, Dr Wakefield, Dr Much and Professor Walker-Smith. It states:

“Background: 12 children were investigated for a new syndrome comprising chronic enterocolitis & regressive behavioural disorder. Children … with a history consisting of achievement of developmental milestones followed by loss of acquired skills including language, plus bowel symptoms, including diarrhoea, abdominal pain and, in some, food intolerance.

Methods: Under sedation, ileo-colonoscopy and biopsy, MRI, EEG & lumbar puncture were performed. Barium follow-through was undertaken where possible & chemistry, haematology and immunology profiles.

Results: Onset of behavioural symptoms was associated, by the parents, with MMR vaccination in 8 of the 12 children, & with measles infection in one child and otitis media in another. All 12 children had significant intestinal pathology; this ranged from lymphoid nodular hyperplasia to apthoid ulceration. Histology revealed patchy chronic inflammation in the colon in 11 cases & reactive ileal lymphoid hyperplasia in 7 cases (no granulomas) 1 case had ileal lymphoid nodular hyperplasia alone, diagnosed on barium follow-through. Behaviourally, they formed a heterogeneous group that included autism … disintegrative psychosis … & post-viral/vaccinal encephalitis. All children exhibited features of severe developmental regression. …

Conclusions: We have identified significant gastrointestinal pathology in association with behavioural regression in a selected group of previously, apparently normal children. In the majority there is a clear temporal association with possible environmental triggers.”

THE CHAIRMAN: I am sorry, Mr Thomas, can I just make a request to you. Can you please just go a little slowly. The reason for that is that you may have read that a few times before, but it is the first time that is coming in front of us.

MR THOMAS: Certainly.

THE CHAIRMAN: And we have to go on absorbing the information.

MR THOMAS: I will go a bit more slowly, and also the type on this page is quite small. Can we now look at the next abstract that you sent, 31.

“Ileal-caecal lymphoid nodular hyperplasia, non-specific ileo-colitis with regressive behavioural disorder and food intolerance: A case study.”

This is authored by Professor Walker-Smith, Dr Davies, Professor Murch and Dr Wakefield. It says:

“A boy developed normally till age of 20 months. At 13 months had MMR immunisation. 2 weeks later had head banging & screaming at night. From 20 months he lost vocabulary and had behavioural regression with hyperactivity. He also developed chronic diarrhoea and weight loss with evidence of food intolerance. There was some response of both behavioural and gastrointestinal symptoms at age of 4 years to an elimination diet. He had extensive negative neurological investigations and was diagnosed within autistic spectrum.

At 8 years 8 months, ileo-colonoscopy revealed ileo-caecal lymphoid nodular hyperplasia with apthoid ulcer. There was mild chronic inflammation which was patchy through the ileo-colon with mild crypt distortion and occasional acute cryptitis but no granuloma. He was treated with enteral polymeric feeding … for two months with relief of diarrhoea and improvement of behaviour. Repeat ileo-colonoscopy and biopsy after 2 months showed complete return to normal. Serum tumour necrosis factor …[is given]. Median interleukin … [is given] … in the ileal mucosa pre-treatment was 5.19 … and after 1000.

Subsequent attempts to reintroduce food has revealed persistent food intolerance and behaviour deterioration after some foods. Oral mesalazine therapy has led to further behavioural improvement.

This child has ileo-caecal lymphoid nodular hyperplasia with non-specific entero-colitis associated with a regressive behavioural disorder, chronic diarrhoea and food intolerance. Enteral nutrition led to healing of the ileo-colonic pathology and improvement in behaviour. Further behavioural improvement occurred with oral mesalazine. Does this child have Crohn’s disease or a new syndrome?”

What was your reaction having read those two abstracts to which your attention had been drawn by Professor Walker-Smith?
A I did not feel that they offered strong enough evidence of either a link in abstract number 30. Although there was mention of controls it did not come across how the controls were selected, and I felt this was a fairly small case series. Similarly, abstract number 31 – one case by itself, although of interest, would not be enough evidence to approve a treatment or an investigation.

Q Did you, in fact, change your position as to whether to grant an ECR?
A No. I felt obviously this was a field I was unfamiliar with, and I would be interested to see what the results of research were, but not that it would affect our decision to refuse ECR.

Q You say you would have been interested to see the results of the research. What was your understanding of the nature of the referral you were being asked to make?
A From my position, it was whether it would benefit the patient, JS. That was the fundamental reason for approving an ECR. It would have to demonstrate that the benefit would be real, and that it would not be able to be realised unless the patient was sent to a centre or unit outside of Worcestershire or the West Midlands. That was the very basic requirement that had to be satisfied and I did not feel there was evidence of that benefit.

Q Having seen the contents of Professor Walker-Smith’s letter and read the abstracts, did you form a view as to the nature of the referral that was being sought?
A I believed it was not treatment; it was more based on research.

Q And did that have any relevance in terms of your decision as to funding for an ECR?
A It did have some influence. I was aware, certainly, that research can be based on valid investigations and treatment. From my point of view research being carried out on a patient who was classified as an ECR was not per se reason to refuse, but there had to be a clear benefit to that individual patient.

Q Dr Kirrage, so far as you are aware, was the ECR in this case actually granted?
A No. I do not believe it was. We have checked, but could not find any evidence that it was granted.

Q Finally, Dr Kirrage, could I ask you to turn to the GP records for Child JS at page 97.
A Yes, I have that.

Q Can you see, half way down the page, there is an entry “11/11/97”?
A Yes.

Q It says:

“Dr Kirrage – re cancelled colonoscopy ?Defer until more evidence forthcoming”

Do you remember making a telephone call or having a telephone call with anyone at the GP surgery in relation to the proposed admission on 12 November?
A I am afraid I cannot remember it. It would be my normal practice to try to do that, but I honestly do not recollect it.

Q Just turning to the question of the impact as to whether or not to make an ECR, of the question of whether a particular referral involves research, if you form the view that a referral to hospital is purely for research and does not hold out the prospect of any real benefit to the patient, do you in those circumstances ever make an ECR?
A Not normally. At that time the position on ECRs and research was rather blurred for me. I have subsequently found out that there is clear guidance, or there was clear guidance about that. I suppose that I had a different way of looking at it, which was that there had to be benefit to the individual patient, but felt that research could very easily be done. I would not prevent research if that parameter of benefit could be satisfied.

MR THOMAS: Thank you, Dr Kirrage. I do not have any more questions for this witness. I see that it is ten past eleven, and perhaps it would be a convenient moment to take the break now.

THE CHAIRMAN: Yes, indeed. I think it is ten past eleven. We will now adjourn for our usual 20 minutes mid-morning break.

Dr Kirrage, I have to remind you: you are still under oath and in the middle of giving evidence. Please make sure that you do not discuss this case with anyone, including any lawyers, during this break. I am sure someone will look after you.

We will now adjourn and resume at half past eleven.

(The Panel adjourned for a short time)

THE CHAIRMAN: Mr Thomas, you had finished your examination in chief.

MR THOMAS: Yes, indeed.


MR COONAN: I have no questions, thank you.


MR MILLER: Sir, may I make it clear for the transcript and for the Panel that this case has nothing to do with The Lancet children. It is not part of the 12 Lancet children. This is a totally separate case.

Cross examined by MR MILLER

Q Dr Kirrage, in 1997, when you were acting as a consultant in public health of medicine for Worcestershire Health Authority, did you have any clinical role?
A No, I did not.

Q What had been your substantive posts in clinical medicine before you went into public health medicine?
A By substantive, do you mean consultant post?

Q Any clinical posts obviously I do not want your pre registration posts.
A I had entered the extra vocational training scheme for general practice and as part of that had posts as a senior house officer in a number of specialties, including paediatrics, general medicine, orthopaedics, urology, and Accident and Emergency medicine.

Q The usual GP training vocations?
A Yes. I also spent a year in anaesthetics.

Q At what level?
A At a senior house officer level.

Q When you said that you had some experience in anaesthesia, it is that year as an SHO in anaesthesia that you draw on particularly?
A Yes.

Q We do not need to worry about what your position is now, but then in 1997, you were working for the health authority which, in those days anyway, was the purchaser in the purchaser/provider relationship, so locally based in Worcestershire.
A That is correct.

Q And responsible as a gate keeper, that is your expression, for extra contractual referrals?
A That is correct.

Q The Panel have become familiar with this, but at that time, the health authority would purchase care from local trusts within the Worcestershire area. It would also purchase care from other regional centres and sometimes national centres.
A Yes.

Q It follows from the fact that you had such a responsibility that your health authority obviously permitted such referrals and there were extra contractual referrals if it was considered appropriate?
A Yes.

Q That would be to specialist doctors outside your area and with whose institutions there was no contract?
A Yes.

Q These would be based on a one off application based upon the patients’ needs and if it involved clinical issues, and if you, as the gate keeper, felt that it was appropriate, you would advise the health authority to sanction such a referral to that particular institution or that particular doctor?
A Yes, that is right.

Q You will appreciate that the Committee has heard quite a bit of evidence already from various different sources, but up to now it is unclear where the application for an ECR comes when it is received in this case by the health authority, the purchaser, who makes the application for an extra contractual referral. Can you answer that in respect of your own health authority in 1997?
A Yes. My understanding would be that typically a GP in Worcestershire looking after a Worcestershire resident would make a referral to a specialist provider for which the health authority did not have a contract. Alternatively, they may have made a referral to a local specialist who then went on and suggested a referral to a specialist provider outside of the West Midlands region, for example, but such requests would be activated at some stage by the referring doctor, either the GP or, if you like, an interim specialist. That would be processed from the ECR, the extra contractual referral department, in the named provider who would contact Worcestershire Health Authority’s extra contractual referral office. This is the office in which Daniel King would work. They would be reviewed and, in certain circumstances, when the reason for the referral was unclear, that would be then referred to me for a medical opinion.

Q If there was a clinical aspect to it, presumably Daniel King did not have any clinical expertise?
A That is correct.

Q So it would need to be run past the gate keeper on the clinical side which was you at the time?
A Yes.

Q The suggested provider of the care, just as an example in this case, we use the Royal Free Hospital, would initiate the request to your health authority for cover for an ECR?
A Yes. Essentially it was a request to the effect that the health authority would fund the treatment and therefore the hospital that the patient had been referred to in this case the Royal Free would request that the health authority would support funding for that particular case.

Q Because again at the time, in these enlightened reforms, the purchasers paid for the care provided by the providers. In this case for this purpose the Royal Free was a provider and therefore it would need to be paid by a purchaser whoever that was?
A That is right.

Q If it was a local patient, presumably the local health authority would pay for it, but outside its area it would need to be paid for by a health authority?
A That is right. Each health authority would cover a specific geographical area of the country.

Q In your case, you are the clinical arbiter as to whether or not in a particular case an ECR was merited. That would be based upon your general medical knowledge, about which you have told us, in consultation with anybody else who might have been looking after the patient, or perhaps the general practitioner who wanted to make the referral?
A Yes, that is right. Sometimes, for example, a decision would be made and you would need to ensure that you had taken all factors into consideration. For example, if a patient had been on holiday in another part of the UK and had an accident and been treated in a part of, say, Scotland, it may be that if they had family living locally, it might be appropriate that further treatment would be continued at a distant hospital. It was not just on purely clinical and effectiveness grounds; one also had to take into account what would be best for the patient.

Q That might be something that your colleague, Mr King, might have been able to do on this own that aspect of it because it does not involve an assessment of whether or not there is a benefit to the patient in terms of treatment?
A Yes.

Q We know in this case that the Royal Free made the request to your health authority for an ECR, because we have seen the paper trail internal documentation. It remains to be seen how it got to the Royal Free in order for it to come back to Worcester, but you can look at it from your end because that is the documentation you have been aware of. Your position once there had been a clinical issue to trigger your involvement, you say would be to consider the best interests of the patient. It is a balance for you, is it not? It is a question of whether or not the benefit to the patient is sufficient to justify the extra contractual referral.
A Yes.

Q Bearing in mind that the bottom line is that the health authority is going to have to pay for it?
A Yes.

Q In this case, we have seen a letter that Mrs S sent to Dr Mills, a community paediatrician, with whom I imagine you were well familiar, you knew him well?
A Yes, I did.

Q If you look at page 209 in the local hospital records, there can be no doubt, doctor, that on the face of it this was a letter from a pretty desperate parent was it not? Reading from the second paragraph,

“As you know, he is presently a weekly boarder in an autistic unit at XXX. His care assistant has noticed he seems to become very agitated before a bowel movement and that he appears to experience some pain or discomfort.

He has a history of diarrhoea although his stools are more normal now. As he has no communication we cannot tell where his discomfort lies. It is very difficult to know if [JS] is in pain because he is so active to the extent of him now scaling a 7ft fence in order to escape. Two weeks ago he was found naked playing in some large pipes in a nearby brook. The whole issue of his security is causing us much worry.

I would very much like to be referred to you as during my last appointment with doctors here it was made very clear that there is nothing they can do to help him medically bar seeing a psychiatrist for drugs and keeping him in an autistic unit.

I feel my doctors do not believe that [JS] has been damaged by the vaccination in spite of the fact that he was a perfectly normal baby, and a bright, affectionate and highly verbal toddler. And in spite of the fact that the vaccine he was given was later withdrawn by the government because it carried a high risk of adverse side effects.
My husband and I feel we must explore every possibility to help our son. As it is now, J has no future at all other than being sedated and confined in an institution”.

That is a pretty sad letter, is it not?
A Yes, I would agree.

Q What she was expressing in that letter and she has expressed it on more than one occasion is that she is desperate for help and wants help that she does not feel she was getting at the time. It is clear from that letter that she does not feel the help she was getting was benefiting her child. That is clear from the letter is it not?
A Certainly when I read that letter, it painted a picture for me of what the problem was for both JS and his mother. I have had experience working with autistic children, so, yes, I was aware of the situation that they were facing.

Q She is saying at the last appointment with doctors it was made clear there is nothing they can do for him medically. I am just trying to work how where the balance lies in your decision making because the parent in this case is making it pretty clear, and pretty eloquently, that she wants to have somebody else investigate her child.
A The parent has a perception certainly of what the outlook was. She also had a perception of the cause of JS’s condition. I also had to consider certainly the views of parents and of patients and also have a responsibility for ensuring that the health authority spent its money and resources responsibly.

Q She is identifying in the third paragraph of that letter the history of diarrhoea, the concern about not knowing whether he is in pain or what might be causing the pain. She has clearly flagged up gastroenterological signs and symptoms, has she not?
A Yes.

Q You say that in consultation with Dr Mills you came to the conclusion that what was being proposed was not likely to benefit the child. You say,

“I looked at the efficacy of the proposed treatment and the ability of the proposed treatment to benefit the patient”.

What was it that you considered was either not efficacious or not for the benefit of the child?
A The history of bowel problems I felt could be most appropriately dealt with by clinicians who were looking after JS and, as such, there was nothing to suggest that the Royal Free had a treatment in mind or, if they did, that it would be superior to the treatment which could be available locally.

Q Tell us, if you would, what treatment for the bowel symptoms was this child having locally? First of all, can I start slightly earlier? What investigations had there been for the bowel symptoms and what treatment was being administered locally?
A I cannot recall that from the notes I have in front of me.

Q You must presumably have satisfied yourself, despite what the mother was saying, that he had been appropriately investigated for those symptoms and was being appropriately treated?
A Yes. I had reviewed his clinical record.

Q It may be something we will have to take up with Dr Mills, because I think, with the best will in the world, you could not say that you had effectively taken over as the treating doctor.
A No, but I had certainly discussed it with the doctor looking after JS.

Q We will have to see from Dr Mills what investigations of the bowel symptoms had taken place and what treatment was in place. Is it right that one of the features which you took into account was that he could be and presumably was being appropriately treated locally for those gastroenterological symptoms?
A At this stage, yes.

Q You said that one of the features which concerned you was the travel to London, which clearly did not concern Mr and Mrs S, because they were asking for it, and the fact that there might have to be investigations under a general anaesthetic, which from your experience, one year as an SHO in anaesthetics, raised the possibility of the slight but existing risk of the general anaesthetic.
A The risk of an anaesthetic is known to all doctors as a significant risk of any operation.

Q Exactly so. That might in itself be seen as being a reason for not ever having a general anaesthetic. The risk is always there for any general anaesthetic. Did you not think that would be a matter which this specialist unit at the Royal Free would not consider as a risk?
A No, but I had a view as to the fact that this could be undertaken locally if necessary.

Q A general anaesthetic locally?
A If necessary, a general anaesthetic.

Q In fact, it had really no bearing, because it would be up to whichever unit was involved, either locally or in London, to make the decision as to whether or not it was appropriate to do a general anaesthetic. It would not be your decision.
A It would not be my decision, no.

Q It would depend upon what views were taken at whichever unit had to deal with it.
A If it was to benefit the patient and that benefit outweighed the risk, then yes.

Q That would be a clinical matter for those dealing with him, would it not?
A Yes.

Q You wrote a letter to Mrs S which you ran past Dr Mills first and said, “If you don’t like it, bin it” in which you set out in eloquent terms why you thought that it was inappropriate for an ECR to take place. That is page 211. It is the letter to Mrs S dated 21 July and behind it is the covering letter, the handwritten letter written to “Dear Andy”. This is the letter we went through. You draft a letter, send it to Dr Mills and said at the end, “If you feel it is not helpful, then bin it.” Just looking at page 211, under this section which starts, “In considering the link between the MMR vaccine” you go on with four subparagraphs which deal with the MMR link. Then you go on to the investigation side of things. Lest it be thought, doctor, that this is original thought which follows, you had in fact looked at a document, had you not, which had been circulated by Dr Elizabeth Miller?
A I looked at quite a few documents.

Q That letter could be read as original thought on your part, the subparagraphs 1-4, and you say you had discussed it with Dr Miller. In fact, you received a circular, did you not, from Dr Miller which made these points?
A You might well be right. I cannot recall.

Q If you would look at bundle FTP1, at page 320, it says “Memorandum to all Duty Doctors”. Do you know what the CDSC is?
A It has been renamed, but it was the Communicable Disease Surveillance Centre in Collingdale.

Q It is from Dr Elizabeth Miller dated 2 October 1996, so before this letter. If we look at paragraph 1 of this and put it alongside your subparagraph, unless you had an extremely good memory of what you had been told by Dr Miller, it looks as though your subparagraph 1 is her subparagraph 1. Is that right?
A Yes.

Q Your subparagraph 2 I think is in fact her subparagraph 4. Is that right?
A Yes.

Q Your subparagraph 3 is her subparagraph 2.
A Yes.

Q And in broad terms, your subparagraph 4, in slightly more summary form, is her subparagraph 3.
A Yes.

Q What you did was to lift what Dr Miller had circulated on the MMR topic and simply put that into the letter that you were writing to Mrs S.
A Yes. We were constantly reviewing what the situation and what the level of knowledge was and I did check with Dr Miller and other colleagues and that seemed to be still a relevant and accurate understanding of what we knew about MMR vaccines at that time.

Q My point was a slightly different point. You simply lifted what had come in the circular from the circular and put that forward in this letter.
A We used guidance that we had available, certainly.

Q We have been told that this letter did go off to Mrs S and then you wrote your handwritten personal letter to Dr Mills in which you felt that you were sitting on the fence. It left both doors open. If it came to it and he chose to refer, that would get your support; if he chose not to, that would also get your support. Is that right?
A Yes. The handwritten note was really to try and not interfere with the doctor/patient relationship or the relationship with JS’s family. Should the condition of JS have altered in any way, such that the benefit and the risks changed, then that would enable Dr Mills to refer JS appropriately. It was very difficult without obviously being the clinician responsible for JS to make any firm judgment other than on the grounds of effectiveness. What I did not want to do was to put at risk a relationship with Dr Mills and JS and JS’s parents.

Q Was it at this point, when you say in the middle of page 213, the handwritten letter, that there was no evidence that this will benefit JS, is this when you made the appraisal of what the treatment options might be for him as against what they were at the time in Worcestershire?
A There was no real information regarding the treatment that the Royal Free were proposing to offer. The referral was for investigation.

Q Had you seen all of the correspondence between Professor Walker-Smith and Dr Mills?
A I do not know.

Q Certainly treatment was being discussed and the experience of the benefit that patients had received from that treatment.
A Yes. What I had to go on subsequently I think was the abstract which we have mentioned at page 31. There may well have been some letters between Dr Mills and Professor Walker-Smith which I have not seen.

Q Because it does not look as though you were copied into that correspondence, and I will deal with Dr Mills when he comes to give evidence, ultimately when it came to the benefit of treatment, that was based on the abstract which was sent to you by Professor Walker-Smith.
A Yes. The timing of the letters and the time at which the ECR was refused is slightly unclear. We have a letter from Daniel King which definitively says that the health authority refuses, but I am not sure whether there were any dates prior to that.

Q I am still not sure at what time you addressed your mind to the question of treatment as opposed to any other aspect of the referral.
A To my understanding, there was no mention of treatment in the request for a referral and it was the treatment which – I may well have considered that if a treatment was recommended, that could have been delivered locally. I do not recall that information or a request for treatment coming for our consideration.

Q You say you may not have seen the correspondence between Dr Mills and Professor Walker-Smith, but certainly you were sent the abstract directly which referred to treatment with mesalazine and enteral therapy.
A Yes.

Q You must have taken it that the reason for sending you that was to show that that treatment had, in one case, albeit in one case only in that abstract, been successful. The abstract is in the Royal Free notes bundle at pages 11 and 13. That is a case report about investigation and treatment, is it not?
A Yes.

Q I know you say that you considered this to be a research referral in November 1997, but what you were being sent by Professor Walker-Smith was an abstract relating to the successful treatment of these conditions. That is right, is it not? What other purpose would there be for sending it? If you read that second abstract on page 13, it is a description of a successful response to treatment.
A I actually would require slightly more evidence to show that that would be applicable to other cases.

Q Are you the person to judge this? This is a tertiary referral centre, a gastroenterological specialist referral unit to which the mother wished her child to be referred. The Professor is writing back to you, including an abstract, to point out that in a particular case they had had successful treatment with mesalazine and enteral therapy. Is it your position to judge, as a former general practitioner, in this aspect of public medicine, whether or not the treatment there is not going to benefit the child?
A No, but my position was to judge whether or not there was a need for an extra-contractual referral. If there was evidence that JS would benefit, why could it not be done locally?

Q Presumably your first port of call would then have been a local paediatrician or Dr Mills, who is the community paediatrician, to find out what treatment the child was receiving locally for those symptoms. Did you make inquiries as to what, if any, treatment he was having for his bowel pathology?
A As I said, I had looked through some clinical notes – not all clinical notes – and discussed the case with Dr Mills. There was no reason at the time in my view that the treatment should not be continued locally and that the extra-contractual referral at this stage was justified, although I was prepared, if further evidence became available, that an extra-contractual referral should be withheld. If there was going to be some benefit to the patient, then most people who were in similar posts as I was, which was to review ECRs, would have come to the same conclusion and approved the ECR.

Q Did you respond to this letter? That is page 11 in the Royal Free Hospital notes.
A This is the fax, the letter from I cannot find any record that I did so in writing. We have looked, but I cannot find that I actually replied in writing.

Q I do not think in these notes, bearing in mind this is the Royal Free end of it, there is any evidence of you responding to that letter.
A No, I cannot find any evidence that I did.

Q By that stage, a decision I think had already been made that there should be no referral.
A Well, the decision, I mean after receiving the letter from Professor Walker Smith, of the decision not to approve the ECR would have remained current, if you like.

Q It was an existing refusal, was it not?
A Yes, and this did not alter that.

Q The position stayed as it was and, on the face of it, it does not look as though you responded to this. One way or another, it would follow that if Mrs S had wanted her child to be investigated at the Royal Free she would have had to make other arrangements?
A As things stand, yes.

Q I think you know from the documentation that Mr Thomas went through with you that she did get an appointment at the Royal Free and the child was investigated and was subsequently investigated and treated as a National Health Service patient. You are nodding your head.
A Sorry, yes. I assume that the patient was treated, investigated and treated.

Q It does not look as if you had any further involvement after receiving that letter.
A That is the case.

Q So if we want to look at what happened in terms of treatment we have to follow the story with Dr Mills?
A Yes.

MR MILLER: Thank you, Dr Kirrage.


MR HOPKINS: No, thank you, sir.


Re examined by MR THOMAS

Q I just have a couple of matters, Dr Kirrage. You were asked by Mr Miller the extent to which you took into account when making a referral the parental wishes. You told us that you did take those into account. You also told us that when you were making the decision as to whether or not an extra contractual referral would be approved, you were looking at the best interests of the child. What I want to ask you to clarify is this. If you are faced, as you were in this case, with a letter which, as Mr Miller tells us, is a very sad one expressing very strong wishes indeed from the parents as to whether or not there should be an extra contractual referral, do you simply automatically grant an ECR where there are very strong feelings of that type or do you continue to bear in mind the best interests of the child?
A In a case like this, the parents wishes carry a lot of weight obviously and certainly I have found, I certainly felt for the mother of JS because I think I had some insight as to her concerns and worries. It is an important thing to take into consideration I think, but it does not always mean that one should, or can approve an ECR on that alone. I mean, the first duty really is to the welfare of JS.

Q You were also asked by Mr Miller as to your reason for not making the referral to the Royal Free because, as he pointed out to you, you were being provided with information by a professor of paediatric gastroenterology from a tertiary referral centre. On that basis, Mr Miller asked you effectively what did you consider you had to add to the information he was providing you with from your standpoint as somebody he described as having GP training? Now, at that stage, were you aware that JS was under the care of Dr Mills?
A Yes.

Q Were you aware of any significant hindrance that there was for Dr Mills making any referrals that he considered to be appropriate, whether gastroenterological or indeed any other referrals?
A No.

Q Were you aware of any particular defects that existed in the local paediatric service at that time which would have prevented him from making a referral if he considered it appropriate?
A No.

Q Can you turn to page 212 to the second page of the letter? Mr Miller also asked you as to your involvement in making decisions in relation to gastrointestinal matters. Could I just ask you to look at the penultimate sentence of the first paragraph beginning, "moving on to". If you look at the last penultimate sentence it says: "My understanding is that Dr Mills has been very exhaustive in his efforts to ensure that JS was not subjected to unnecessary and uncomfortable tests for gastrointestinal symptoms which he was not experiencing. I think this is entirely appropriate in Dr Mills' clinical responsibility." Does that accurately reflect what you considered to be the appropriate course in respect of assessment of JS's gastrointestinal symptoms and what to do about them?
A Yes, at this stage I think it was.

Q Mr Miller also asked you about what your information was in respect of JS's gastrointestinal symptoms. Would it be fair to say that in assessing that you had available to you JS's mother's letter at page 209?
A Yes, I did.

MR THOMAS: Yes. Thank you very much. Those are all my questions.

Questioned by THE PANEL

THE CHAIRMAN: Dr Kirrage, the Panel Members may have some questions. If they have any then I will introduce them to you. I have some questions if you do not mind, Dr Kirrage. Can I first of all ask you, I think you said you had the vocational training for general practice.
A Yes.

Q Can you just give me some idea roughly what time it was: early 90s, late 80s?
A I started vocational training for general practice in 1985 and completed it in 1988.

Q As part of the general practice, that vocational training, you said that you did a certain number of jobs and I could not make a note of it. Could you remind me again?
A Yes. I did accident and emergency medicine before entering the vocational training scheme. I did six months of psychiatry, again before entering a vocational training scheme. I then did a six-month paediatric job which included community paediatrics and a special care baby unit. I did a six-month general medicine post. I did a six month in obstetrics and gyneacology post. Then I think that was, without looking at a CV, the extra vocational training and then that was followed obviously by time in general practice as a trainee in two practices.

Q Was that for six months each in two practices?
A The first practice was for three months and I believe the second practice was for longer: eight months.

Q So, altogether, that will be 12 months, including your one month holiday?
A Yes.

Q So that would be your GP registrar attached with a general practitioner?
A Yes.

Q Did you become a substantive GP after that?
A No, I did not.

Q After you finished this three years altogether, the vocational training, including the hospital jobs and your GP attachment, did you do any other work?
A Yes, I did some general practice locums. I did a year of anaesthestics and I did approximately ten months of psychiatry.

Q So your paediatric experience was six months’ paediatric experience somewhere between 1985 to 1988?
A Yes.

Q And also from 1985 to 1987?
A That is correct.

Q Your last year was a GP attachment?
A Yes. I also did some extra community paediatric experience while on the public health medicine training attachment.

Q When did you actually join public health?
A I joined public health training in September 1990.

Q Until when?
A Until 1996.

Q What was your role in public health? Were you in Worchestershire at that time?
A Do you mean during that period of public health medicine training?

Q Yes.
A I was in East Anglia and in Devon.

Q Training in public health means you were attached with somebody, can you give me some idea?
A Yes. You are working within public health medicine departments with an approved trainer carrying out project-based work and general training into a large number of topics, which would consist of commissioning specialist services, reviewing specialist services, doing needs assessment for populations, emergency planning, and community diseases and health protection training.

Q Roughly when did you join Worcestershire Health Authority?
A I joined on 1 April 1996.

Q Your appointment with Worcestershire Health Authority was a consultant in public health?
A That is correct.

Q At that stage, were you given any training in how to deal with the request for the ECRs?
A The extra contractual referrals had been part of my general public health medicine training, albeit a small part. The decision on how you process extra contractual referrals at the time was part of a programme campaign, if you like, to improve evidence-based medicine so that there was a move to critically appraise scientific literature and ensure that only services for which evidence of effectiveness existed were purchased. That was ongoing throughout my early days in Worcestershire Health Authority. I was part of a clinical effectiveness group and other groups looking at evidence-based medicine.

Q That would be very close to the date of this incident because I think you only joined Worcestershire Health Authority in early 1996. Is that right?
A April 1996.

Q The first letter that we actually have from the mother, which was referred to as a ‘sad’ letter, that actually happened on 5 July 1997. That is virtually almost about a year’s time when you had only been working in the health authority.
A Yes.

Q And I think you actually said that you had the discussion with Dr Miller?
A Yes.

Q It was after the discussion, you said, that you came to the conclusion that it will not benefit the child?
A I think I had probably formed a partial view as to the benefit, but this was part of checking that this was the case and that certainly I had also discussed it with colleagues in my department as well, as I did with particularly difficult-to-decide ECR cases.

Q Did you consider this a difficult decision?
A I found every decision where you were running contrary, perhaps, to the wishes of parents in particular, difficult.

Q Surely there are some decisions about requests for ECR which are obviously easier than others?
A Yes. I found it difficult at a personal level. I did not find it difficult on the evidence base.

Q That discussion that you had with Dr Miller – was that a personal meeting? Was that on the telephone?
A Dr Miller was phoned by a number of colleagues, and I phoned her on a number of occasions when I had difficulties about queries regarding vaccination or, I almost say, clinical problems, but quite often we would have some difficult vaccination queries as to what vaccination programme you should do, perhaps, for an individual who had particular circumstances, and she was always very available for advice. So I phoned her and said, essentially, “Is there anything new that we should know about before coming to this decision?” And she was very helpful and provided the advice that at that stage the evidence to show that MMR vaccination was likely to cause autism was very restricted.

Q So that was a telephone discussion you had?
A That was a telephone discussion.

Q And I suspect that you initiated that telephone call?
A Yes. It was really just to double check that I was not making an error.

Q Did that discussion involve at any stage a general practitioner?
A This is something I cannot recall. As I said, I spoke to colleagues, and I spoke to a colleague, a microbiologist, and asked her for advice as well, but I do not recall. I have no recollection. I would normally always speak to the GP.

Q But he would have been in such a case a very useful resource for a lot of other information that he would probably have, that you may not have had at that stage?
A That is right. Often a referral for an extra-contractual referral would be made by a GP, so it was always important, out of courtesy if nothing else, if you were unhappy with it, that you would always speak to them directly and explain what your concerns were and ask for other information.

Q Now to this handwritten note which I think you referred to: it may be that I have misunderstood your position on this. You said that you wrote this handwritten note so that you do not interfere with the continuity of care, or to avoid any interruptions in the continuity of care?
A Yes. In my role as reviewing the extra-contractual referrals, I very often felt quite uneasy about making a decision without taking into account other issues. I also, rightly or wrongly, sometimes felt that it was useful to say no, if necessary. I say “useful”; what I mean is, somebody has to say “no” sometimes and I would rather in a way it was myself, or it would be better for future relationships between a GP and a patient if that came from somebody outside of that relationship. I think it puts a lot of pressure on GPs if they refuse to refer a patient and it can be useful, if you like, for it to be a third party.

Q Again, just to ask about your understanding; I think you said “to my understanding there was no mention of treatment,” and I think that is something like what you said?
A Yes.

Q Maybe I am paraphrasing it.
A Yes.

Q What was your understanding about the treatment? Is it just that treatment means specifically treating somebody either with medication or with surgery, or is treatment actually a much more generic way of describing the whole management of a patient, which includes history-taking, investigations, treatment if necessary, surgery if necessary. So what was your understanding about it?
A My understanding was that treatment is the provision of advice or therapeutics or surgery to a patient, and it was separate from investigation. Taking a history and investigation is not in my view treatment. Treatment is something that one actively gives. It can be advice on a treatment regime, and that advice could be given by a specialist consultant to a GP, for example. That would be treatment. But it is actually physically either giving a medicine or some form of intervention.

Q Even if you advise the treatment is not necessary, there may be an issue here that you do really need to have those tests if you consider them necessary, to be able to advise whether you need a treatment or you do not need a treatment. In a way, investigations themselves are part of the management?
A Certainly, yes, it is part of the management. I agree.

Q I think you said you had a telephone conversation with Professor Walker-Smith?
A Yes.

Q And I think you said Professor Walker-Smith made a strong case for ECR?
A Yes.

Q Do you recollect any details?
A I do not think ---

Q We know that we have seen the abstracts.
A I do not recollect the details. I remember the conversation, but not in great detail. I remember that Professor Walker-Smith obviously felt that this was going to be of benefit to JS and referred to research and to the abstracts which he said he would send me by fax, which is what he did. I am afraid that is about all I can recall from that.

Q My final question to you, Dr Kirrage, is about this letter that you wrote at page 211-212 to the mother.
A Yes.

Q Had you any information at that stage about the ongoing study or the study which had gone on and a paper was to be published, or anything of that kind?
A I was a general public health medicine doctor. There were other doctors within my department called “Consultants in communicable disease control” – “CCDCs”. They are doctors more involved in vaccine-preventable illnesses than me, so I was aware that there was a growing controversy. The one thing that struck me was the opening sentence of the mother of JS, in which she mentioned that JS had had devastating damage caused by his MMR injection. I was therefore aware that, yes, there was some controversy in this area.

Q I think you used the word that you had some insight about it? It was very close to the end.
A Yes. I had some insight ---

Q You told that to Mr Thomas, I think, at the end, in the re-examination.
A I had some insight into her concerns, and putting myself in her shoes I realised that if she genuinely believed that the Royal Free offered help for her child, then I could understand exactly how she must be feeling.

THE CHAIRMAN: Thank you. I do not think Panel members have any more questions, but counsel have another opportunity at this stage if they wish to. First, Mr Thomas?

MR THOMAS: No, thank you.




MR MILLER: No thank you, sir.

THE CHAIRMAN: And Mr Hopkins?


THE CHAIRMAN: Can I thank you, Dr Kirrage, for coming this morning and give your evidence. You will be pleased to know that you are now released and free to go. Thank you very much indeed.

(The witness withdrew)

THE CHAIRMAN: I think it is now 12.35, so maybe it is an appropriate time for us to adjourn for the lunch break at this stage.

MS SMITH: I am entirely in your hands, sir, yes. The next witness is the GP to Child 2. He will be considerably longer than we can possibly deal with before lunch.

THE CHAIRMAN: We will now adjourn, and resume at 1.35.

MS SMITH: Thank you, sir.

(Luncheon adjournment)


MS SMITH: Thank you, sir. I am going to call Dr Cartmel, who is the GP to Child 2. I should tell you that unfortunately the records are going to mean referring to rather a lot of files and interchanging between them. There are four volumes of medical records on Child 2: GP, local hospital, Royal Free and then a volume which is called Additional Royal Free and GP records.

THE CHAIRMAN: Can I just check it with you, Ms Smith, first of all? They are the GP records, Royal Free Hospital, additional Royal Free Hospital and GP records, and then Cambridgeshire and Peterborough.

MS SMITH: That is it, yes, sir.

Examined by MS SMITH

(Introductions having been made by the Chairman)

Q Dr Cartmel, could you begin, please, by telling us your full name and address?
A Richard Michael Cartmel. I practise at the Grange Medical Centre, 144 Mayor’s Walk, Peterborough.

Q I think it is right that you are general practitioner?
A I am.

Q You should have in front of you, Dr Cartmel, a laminated sheet which is entitled “Anonymisation key”?
A Yes.

Q Could you just look down it and tell us: were you the GP of the child whose name is mentioned opposite the Child 2 reference?
A I was.

Q We are calling him Child 2, Doctor, in order to preserve his anonymity. If you make a mistake, do not worry about it because the press have been asked to respect that anonymity in any event, but if you would try and call him 2, and I shall try and do the same.
A I will do my best.

Q Thank you. I think it is right that you acted as Child 2’s GP from October 1991 to December 1997?
A Correct.

Q And since then he has been in boarding school so he has not been permanently registered with you, but you still occasional see him when he is at home on holiday.
A Yes.

Q His medical history is contained in his GP records. Did you have the opportunity to review those GP records?
A Yes.

Q And also records from the Royal Free and from the local hospital, the Cambridgeshire and Peterborough?
A Yes.

Q Just in broad terms, first of all, Dr Cartmel, how would you describe Child 2?
A When I first saw him, I thought he was different – certain disabled, not able to communicate well. Not able to communicate at all well; had very little, at the time that I knew him, command of the English language.

Q Did he fit into a category that you recognised, or did you regard him as being in a category of his own?
A Very much in a category of his own.

Q I think it is right that by the time you became involved it was clear, as you said, that he had developmental problems of some kind or another?
A Yes.

Q Was it his mother’s view that he had developed normally until he was about aged 18 months, and then regressed?
A That is what she said.

Q As well as that, I think he had gastrointestinal problems?
A Yes.

Q But principally diarrhoea. Is that correct?
A Yes.

Q Was he, from the time when you were involved with him, and indeed before you were involved, referred to a wide variety of specialists?
A Yes,

Q I just want to look at his early stage, shortly before you were involved to begin with. But before I do that, would you look in the GP records besides you, please at page 86. That is a record, is it right, of his immunisation history, apparent prepared as a questionnaire for adverse effects, but for our purposes I just want to ask you: does that indicate that he had his MMR vaccination on 8 November 1989?
A That is what I understood, yes.

Q And now, Doctor, you are going to have to go back and forth, I am afraid, between the records, and I apologise for that. I want to look at what I think is the first sign of developmental problems. You have a file of records which is called “Additional Royal Free and GP Records”?
A Yes. I have two of them.

Q You have two saying “Additional Royal Free and GP”?
A Yes.

Q They must be identical then. Would you turn to page 7, please? Do you have a letter dated 25 January 1991?
A Yes.

Q From a health visitor to Dr Dryburgh, who was apparently the Chief Medical Officer at the Child Development Unit of Peterborough District Hospital?
A Yes.

Q I will not read the whole of it, but it says:

“I would welcome your opinion on this child’s development. Both the mother and I feel there may be a problem.

He progressed well and reached his developmental milestones appropriately. He passed his hearing test 16.2.89. There were a few single words before the age of 1 yr but none since.”

Then it refers to behaviour:

“His concentration is extremely poor. He will attend to a few tasks, building a few bricks, etc, but easily is bored, preferring just to stare at you with his large piercing blue eyes. The parents are experiencing many temper tantrums since the new baby was born but mother states that father ‘still has temper tantrums at 40’. They are rather an intense couple but there have been no problems with the elder sibling. I wonder if he has a comprehension disorder at worse, certainly his development appears to have remained at the 18/12 level.”

A Yes.

Q When you first started seeing Child 2, did his parents express the view to you that they thought that he probably was not autistic?
A They thought that at the time and, to be honest, I did not know whether he was or he was not. He was different.

Q If we look we can see that reflected in the main GP records at page 191.
A Yes.

Q We see on 11 October 1991, “Brain scan NAD” and then at the bottom,

“High level language problem. Not autistic”.

Is that your handwriting?

A That is my writing, yes.

Q Where did that information come from?
A Probably mother.

Q In December 1991, there was a referral to Professor Neville at the Wolfson. Do you remember that?
A No.

Q If I can take you to the additional records at page 21, please. This is a letter from you to Professor Neville at the Wolfson Assessment Centre and you say,

“I am told by the mother of this young man that you are the last word in the assessment of children with specific learning difficulties. This young child has been variously labelled as non specific brain injury autistic, suffering from a receptive dysphasia and son.

His mother feels that the actually labelling is less important than to ensure that he ends up in the right educational establishment to maximise his abilities to the full. For this reason she wishes to be seen by you. She informs me that is with the full support of Dr Dryburgh, the Child Development Paediatrician, at the Peterborough District Hospital”.

You enclose photocopies of all the hospital correspondence about the child if they assisted Professor Neville.

It would appear that this referral was motivated by Mrs 2, Doctor. Was that a pattern as far as this child is concerned?
A It had quite a lot to do with it, yes.

Q If we go on in those records to page 26, we will see that there was indeed an assessment by Professor Neville’s unit, apparently prepared by a senior registrar, Hilary Cass, and a speech therapist. Just going very quickly through that, there was an early history of a socially responsive baby. Referring to the second paragraph,

“At 20 months, coincident with his breast feeding being discontinued, he appeared to undergo a regression. He became withdrawn and inaccessible with nightly screaming bouts and head banging followed by a dazed/blank appearance in the mornings. He lost his expressive language and would no longer follow commands. He developed asthma which was treated with Ventolin to which he reacted badly. He had always had loose stools, but this became more marked...

Then turning over to page 27, under the heading “Current situation”,

“In the last six months there have been significant improvements in February 1992 started on the Feingold Diet and more recently on a gluten free diet. He now appears less hyperactive and will focus attention for longer periods...”

There was a speech and language report thereafter. Then at the bottom of the page, under “Conclusions”,

“2 presents as a boy with difficulty in the social communication disorder spectrum. Because of his limited attention span, it is difficult to estimate his non verbal potential. On the basis of the history, he is most like a group of children who progress normally until 20 months of age, when they undergo an autistic like regression. There is often a family and/or personal history of allergy, and indeed [Child 2] has both. Most of this group seem to have some spontaneous recovery at 3 1/2 to 4 years, often with a good eventual outcome, although they continue to have social communication problems. The etiology of this condition is not known, but an allergic origin has been suggested”.

There is a suggestion there that Mr and Mrs 2 should contact the Allergy Induced Autism Group and also a particular specialist called John Richer in Oxford and, at the bottom of the page, suggesting a further assessment there subsequently.

If we then go, Doctor, to the GP records we can follow this through as far as you are concerned, at page 194.
A Yes.

Q There is a note at the top is that your writing?
A Yes.

Q Can you just tell us what it says from “Very positive” from then on?
A “Very positive to the” there is a hole punch through that word, but something “allergy picture of allergy induced autism” and that there is a biochemist working in Birmingham called John Richer who is a clinical psychologist at Oxford with an interest in diet. “Is this milk allergy too?”

Q There again, would that have been a consultation with Mrs 2?
A Yes.

Q Then if we can go back to the additional records at page 37, this is another referral by you to Professor Davis this time, who is in the Chest Department at Bartholomew’s Hospital dated June 1992.
A Yes.

Q This one says,

“Mrs 2 has been informed that you are the non pareil as an allerologist. Her son, 2, suffers severely from learning difficulties and has been labelled somewhat uncomfortably as autistic. However, there is a good deal of information coming in from sometimes rather suspect sources that learning difficulties may have a contributory factor in some form of food allergy. Indeed his behaviour is quite improved since he has been on a formal coeliac diet. He is also known to go extremely wild after Tartrazines have been anywhere near him.”

What are they?

A Food coloured dyes, the things that make Coca cola brown and orange squash orange.

“He has been seen by a number of paediatricians who have produced as many ideas of their number but one’s general feeling is that the interest in any etiological findings would be the corollary as to where we go from here.”

You ask him whether Professor Davis would see him. Is that correct?

A That is correct.

Q Again, Doctor, this association with behavioural disorder and allergies that you referred to there, where did that information come from? Can you recall?
A Originally from the referral that we talked about, Hilary Cass. I suppose most of it must have come from mother. Certainly that was where I had heard of Professor Davis from.

Q Then if you go back to the GP records, please, at page 260, we see there an involvement of a Dr Rolles who is the consultant paediatrician in Southampton.
A Yes.

Q This is a letter into which you were copied dated November 1992 following an assessment by Professor Warner who was the Professor of Child Health when the referral had originally been made. The doctor says,

“Following 2’s assessment by Professor Warner, he had a discussion with me and I agreed to see the patients with a view to bringing 2 into our assessment service for children who are autistic or who may have related disorders.”

He pointed out to the parents that his particular interest was both in coeliac disease and also in autism.

“... Therefore, I found it of particular interest as 2 had been thought at various times have some cross over problems between these two conditions. I work very closely with Professor Warner, whose particular interests are allergy in a variety of settings, so again these interests are complementary”.

Then he sets out the first history. On the second page, under “The First Year” that his milestones were normal, although it was note worthy that he had no clear words at that stage.

Then under “The second year of life” he says,

“During the second year of life 2 was more active and it was during this twelve months that one or two changes appeared which subsequently were looked on as being abnormal. He stopped playing on his own, and demanded companionship”.

Then going down to “Age 2½”,

“At this point he was referred to the Nuffield Assessment Centre in London and was seen by a specialist, Dr Tony Martin, who concluded that he was probably mentally retarded. From that point until he was about 3½ there was no further major assessment but during the beginning of the third year of life he was noted to lose weight fairly rapidly and the family, in their despair, looked for other solutions. Because of the possibility of the effects of food causing his problems he was put on a Feingold diet which, as the parents described it, was a wide and wholesome diet. On that the dribbling stopped, his diarrhoea. which had been a problem, became more normal and it was at that stage that certain clearly allergies were identified in the parent’s minds”.

They noted certain foods caused a rash.

Then going on to the next page,

“At the present time the parents feel that 2 probably is not autistic. They do feel that there is a generic problem and they recognise that there are some interesting family links here”.

Then it refers to the fact that 2 has an 11 year old brother who was thought to be typical of Aspergers.

Going down,

“In addition to the generic problem which they feel relates to the boy’s speech and behaviour problems, they feel that there is a gut problem which causes through foods, behaviour abnormalities and possibly abdominal pain. They were not certain, even on being pushed, whether or not these two problems of the genetic tendency and the bowel difficulties were related by a common causative factor or simply that one might aggravate the other. They brought up the possibility that this is in vogue at the moment in many circles that somehow this child may have chronic candidasis which can influence bowel function and has been thought by some people also to influence brain disorder in such diverse conditions as autisms and ME for example. The parents would like to consider the use of Nystatin impirically and I said that from a personal point of view I could not see any contraindication to this as a short sharp course and it could simply be a test. I certainly do not feel that there is any evidence anywhere for using Nystatin on along term, either continuous of intermittent base.

The other form of treatment that sometimes work well in chronic diarrhoeal illnesses where there is not good evidence of continuing malabsorption is Metronidazole. This probably acts not so muck as an antibiotic to kill off pathogens, but more as a drug which simply stabilises gut flora in a slightly new pattern. I would think it would be entirely reasonably to try this child on a three day or a ten day course of Flagyl for example of you to wanted to try it”.

Going on to the next page,

“I asked the family specifically what they felt was not autistic about this boy and they felt that he did not fit very comfortably in the category because he is very social, he is mischievous and interacts well with other children and adults. He is also not obsessive ... Having discussed the types of problems that this boy was encountering and the common interest that Professor Warner and I have at looking at allergy and related conditions he is said I hope we are agreed we will go ahead put him through our familiar liaised assessment service”.

Then going down to the bottom of the paragraph,

“Following that assessment I would discuss with Professor Warner and the family whether at a later stage other investigations should be done looking more specifically at food allergens or even idiosyncratic responses to food to see if we could find or define ways of modifying his body chemistry on a way that could improve his performance”.

Then at the bottom of the page,

“PS Professor Warner undertook document various including a full blood count”

and various other blood tests. That was the letter from Dr Rolles, who is a consultant paediatrician at Southampton General. Is that correct?
A Yes.

Q So he was your local paediatrician?
A No.

Q I am sorry, no. His involvement was obviously through Professor Warner.
A It was Professor Warner, from what I understood, did the referral to him.

Q Then you referred the child to a Dr Tuck.
A Who was our local paediatrician.

Q That is in the local hospital records at page 208. Can you recall, Doctor, what the reason was for this referral to Dr Tuck, the local consultant paediatrician?
A As I said in the first paragraph there, I was feeling that there was more and more information passing me and I was way out of my depth, and it was well worth contacting the local consultant with somebody I could at least see and talk to on a rather more regular basis.
Q We see what you say there, “This is the little lad who I mentioned to you on the telephone the day before last. As you can see, he has been seen by a great many specialists armed with a great deal of learning. There is obviously considerable anxiety as to why this child who appears to have developed normally up to about 18 months has slipped backwards. The story of odourless vomiting and the suggestions of malabsorption and partial responses to a coeliac diet and B12 injections seems to suggest that there may be an organic cause to his problems.

“As you can tell from this, I am fairly confused about this child, but as you will probably find reading through the enclosed letters I am in fairly illustrious company. As you worked out from our discussion, he never been formally been tested for hypochlorhydria or coeliac disease.

The next question that follows is, if it does turn out that he is malabsorping, as certainly his mineral study suggest, will reversing this state have a positive effect on his intellectual development? If the answer to this question is yes, then I thin probably any heroic activity is justified. If not, then I think this is something that should be discussed too that should be discussed openly with his mother.”

Does that sum up your position at that stage?
A It does, but I cannot find it. Where is the letter you are reading?

Q It is at page 208 of the local hospital records. It is a letter from you to Dr Tuck. Do you have that now?
A Yes.

Q Did that accurately summarise how you were feeling at that stage about the amount of involvement by consultants?
A Yes.

Q Then there is a response to that which is at page 289 in the GP records. This is a letter back to you from Dr Tuck. He says he has gone through all the correspondence – there had obviously been some conversation between you on the telephone – and:

“It seems to me that the whole clinical picture fits well with Asperger’s syndrome. There really is no clear evidence of malabsorption, though the correspondence contains little or no factual information about his physical growth. I note that he is said to have improved on a glutenfree diet, but the pattern of his psychological abnormalities is not at all the kind of thing which I would associate with untreated celiac disease.

I am not impressed that the allegedly low concentrations of various minerals in his sweat constitute good evidence of malabsorption in the sense that you and I would understand it.”

He goes on:

“I also have the distinct impression from this correspondence that the parents are reluctant to accept a diagnosis of Asperger’s syndrome and concentrate on practical management. I have the impression that they are desperately casting about for someone to give them an alternative diagnosis, and a magic cure. Whilst I can readily understand this attitude, I think it is unlikely to prove helpful to 2.

2 has already been assessed by a large number of medical, para medical and quasi medical people. I don’t think there is any useful purpose in adding my name to the long list, particularly as I am very unlikely to offer an opinion which is significantly different from that of Dr Rolles and his Unit.”

Did you find from your own point of view, as the GP, that a satisfactory assistance to you?
A It certainly helped my thought processes as to what was going on.

Q I think shortly thereafter, did you also arrange for Child 2 to be seen by Dr Bhatt at the Chelsea & Westminster Vitamin B12 Unit?
A Yes.

Q I can take you to the notes if you need to see them, so tell me if you do not remember, but was that also because the mother wanted to explore the avenue of a B12 deficiency?
A Yes.

Q Was the child subsequently admitted to the Chelsea & Westminster? If you go to page 283 of the GP records, you will see a reference to an admission with a main diagnosis of vitamin B12 deficiency, an elective admission to the Chelsea & Westminster.
A Yes.

Q I think that was in June 1994. In January 1995, you wrote again to Dr Tuck. I would like just to look at that letter, if I may. It is page 288. This is a letter which you wrote, saying:

“You will remember our discussions this time last year about this lad. Since then he has been seen by all sorts of exceptionally (cerebrally) gifted gentlemen who have sent various letters and things back to me, which to be honest I am totally out of my depth to comment on their value and validity. Mrs 2 and I feel it is important that there is somebody who is at least on the same intellectual level as these good people who is locally driving this chap’s case.

On a personal level I am finding it terribly difficult to answer questions for ECRS from Tony Jewell’s department when I am really totally out of my depth as far as the diagnosis and treatment. My personal thought is that all these various tests and things that are going on are frightfully intellectually interesting; but I am far from convinced of their usefulness as far as 2 himself is concerned. On the other hand, and I think that this is very significant, Mrs 2 finally expressed the fact that she was reaching the end of her tether with 2, in the consulting room the day before yesterday. We would both be, therefore, very grateful if you would take over the clinical driving seat. She has also requested a referral to a Dr G. D. Kewley, who is a paediatrician at the Learning Assessment Centre at the Ashdown Hospital … West Sussex. Exactly who this man is or what he is about I do not know yet and I have written asking him for his CV which I can then present to you and to Tony Jewell who will no doubt want to know a little bit more about him prior to releasing any ECR money.”

Doctor, we have heard in this hearing a bit about the ECR arrangements. Can you just explain to the Panel exactly what that letter was aiming at?
A Tony Jewell was the director of public health at Peterborough, I think it was a health authority at that particular point in time, and we were part of a group of three practices who held a budget under the fund-holding system. We needed to be able to explain to Tony Jewell, who was, as I say, a consultant in public health, exactly what this was all about and to therefore justify the referrals. As we were responsible for up to £5,000 worth of treatment in a year and thereafter the health authority was responsible for all and everything over the top and Tony Jewell was of course interested to see this young lad’s name come up fairly regularly when billed for the costs. This was really the flavour of what the second letter was about. Simon Tuck, not being a local consultant, was therefore not an ECR and I was recruiting him, if you like, partly as a vetting agency to see what this was all about.

Q You obviously had that concern and responsibility as far as the financial side was concerned. As far as the treatment side was concerned, you as a GP expressed doubts. You say you thought it was all frightfully intellectually interesting, but you were far from convinced as to the usefulness of some of these referrals as far as the child was concerned.
A Yes.

Q Why were they coming about? Why were they happening, this large number of specialist referrals?
A They had been requested by mother. Mother is a highly intelligent person and there were times when I could not justifiably say why I would not do a referral. This was a case of a child who I did not really understand at all well and a lot of the letters came back to me were equally incomprehensible and there were moments, as I suggested to Simon Tuck, that they were muddy for a very good reason: that nobody really understood him.

Q If you would go on to page 290, please, we will see a letter also from the Chelsea & Westminster, the Vitamin B12 unit, this time from a consultant paediatric neurologist, Dr Cavanagh, dated January 1995, referring to Dr Bhatt, who is the B12 specialist. There are references as to why there were problems in relation to the B12 testing. He goes on in the third paragraph:

“I wondered what you felt about this and whether you felt that it might be appropriate for you to refer him to a paediatric gastroenterologist, perhaps nearer to home and I did in my conversation with his mother say that there is a good unit at the Birmingham hospital with Professor Ian Booth as a paediatric gastroenterologist there.

I have left it that Mrs 2 will make contact with me here again if she wants us to go along the line of treating 2 symptomatically with Ritalin but I have not made a definite appointment to review him again until then.”

So that was the first suggestion of the involvement of a paediatric gastroenterologist. After that, there was a referral to a local child psychiatrist, Dr Wozencroft. This is page 198 of the local hospital records.
A Yes.

Q It would appear that this is a letter from you to Dr Wozencroft. So it would appear there had been some contact before that. You set out the various problems he has and that there have been problems about B12. You say:

“His parents have access to all the information through the Asperger Society etc., of exactly the right people to see, now personally I do not feel that I am in a position to judge the merits and de-merits of learned paediatricians, my feeling is that he has been seen and had a number of tests done on him which have been extremely good for the intellectual gymnastics of the paediatricians but have not, however, achieved one iota of improving the situation in the 2 household. The situation therefore is that the 2s wish to have a consultant who will act as a partner and assessor of the ways they have been and the ways they wish to go with 2. They may also require him to do a tertiary referral, for which no doubt he will be expected to judge the validity of this tertiary referral. A consultant can do a tertiary referral a GP cannot. If a referral is not deemed to be appropriate by the consultant, they wish to have a frank and open discussion with him as to why this is not the case.”

Then you refer to a particular case at Addenbrooke’s in relation to possible financial rationing. You say:

“The 2s have actually not mentioned rationing at all but … it might become a topic for conversation. The family however, do expect their Mentor to give a valid value judgment of the direction 2’s care should be going. If you feel that you are in a position to be able to do that thing, I am delighted for you to give it a go. Our local paediatricians apparently do not wish to be involved in such a partnership, which I must admit I find rather sad.

Wishing you the compliments of the season.”

Can you tell us how that came about, the involvement of Dr Wozencroft?
A I suspect it was probably because Simon Tuck did not want to get caught in the cross fire and Wozencroft was also a consultant in Peterborough whom I knew.

Q When you say “the cross fire”, can you just spell out what you mean by that?
A If we go back to Dr Tuck’s original letter in 1994, when he said he has seen everybody else, is there really a place to add my name to the list of them.

Q So you turned to Dr Wozencroft and Dr Wozencroft I think was prepared to help. Is that correct?
A Yes.

Q He made a referral, which is at page 184 of the local hospital records. This is a letter to Professor Walker-Smith at St Bartholomew’s Hospital.
A Yes.

Q It is dated June 1995.
A Yes.

Q It says:

“I write to ask you to see 2 and to express an opinion upon him. I know that his parents have contacted you and your colleague, Andrew Wakefield. The family doctor, Dr Cartmel also wants the benefit of your opinion.

2 is a boy who has been seen by a great many doctors over the years. I have become involved only recently. My tasks are to take an overview of the situation … and to help the family find their way to any source of medical help which might be available.

At present, 2’s condition in Child Psychiatric terms falls within the diagnostic category of Autistic Spectrum Disorder. Plainly, such a disorder can arise through more than one mechanism. Mr and Mrs 2 feel that there is a strong physical component to 2’s difficulties. I must say that I agree with them. At the moment, 2’s physical, medical and emotional states are all deteriorating. In the past, just such a deterioration has been nipped in the bud by B12 injections. I think it entirely legitimate for Mr and Mrs 2 to be seeking your expertise.

For my part, I am not familiar with the research evidence which connects immunisation with difficulties like 2’s. Naturally I am trying to educate myself in that area. 2’s condition, however, is going downhill and his parents, his GP and I would all be grateful for an urgent opinion from you.”

Before I ask you about that letter, I want to take you to an undated note in the same bundle at page 188. Is “David” Dr Wozencroft?
A Yes.

Q It refers to a telephone call from you, wanting to talk to Dr Wozencroft about referring 2 on to somewhere in London. The secretary apparently said that Dr Wozencroft would get back to you. This says that on Wednesday Mrs 2 phoned to request the same and gave the details of Professor Walker-Smith’s name.

“She says they are waiting to hear from you before they can offer 2 an urgent appointment. She said the other person involved is:

Mr Andrew Wakefield, Senior Lecturer, who knows 2. He can be contacted on …. ”

And there is another number given. If I can just take you back to the letter at page 184, can you recall, doctor, how all this came about in June 1995? First of all, do you remember how it was that you heard about Professor Walker-Smith and Mr Wakefield?
A It could have come either from David Rozencroft or from Mrs 2.

Q Did you have any understanding of what they were interested in?
A No.

Q Dr Wozencroft said in his letter to Professor Walker-Smith:

“I am not familiar with the evidence which connects immunisation with difficulties like 2’s … ”

Was that something you knew anything about, that connection at that stage in 1995?
A I do not know whether I had heard of it in 1995. During the last 12 years Mrs 2 and I have discussed it considerably, because Mrs 2 remains one of my patients, as until fairly recently did her younger child, who has now gone off to boarding school.

Q Did Mrs 2 express any views to you and, if so, do you remember when, as to the possible link of immunisation with 2’s problems?
A I know she has talked about it considerably, but exactly when, I am afraid I do not.

Q In fact, you had a letter from Professor Walker-Smith after he had seen the child at St Bartholomew’s, and that is at page 178 in the Royal Free Hospital records. This is one you have not looked at before – the Royal Free Hospital.
A Right, yes.

Q Dr Wozencroft made a referral which you were aware of to St Bartholomew’s?
A Yes.

Q And you now have a letter back from Professor Walker-Smith at the Royal Free. Did you know anything about where either he or Dr Wakefield were ---?
A At that time, no.

Q This letter:

“Dear Dr Cartmel

I have now reviewed [2] and I think inflammatory bowel disease is extremely unlikely and I have had a copy of the letter which Dr Bhatt wrote to you and I do believe that the best way forward is for a Schillings Test. This is a test which is best done by experts and I would recommend that this is done in the Chelsea & Westminster. However, I do think it would be very helpful if a Paediatrician could be involved locally and I have suggested that Dr Mark Beattie recently appointed Consultant Paediatrician in Peterborough might be useful to oversee [2’s] overall paediatric management.

I have not arranged to see [2] again but I would be happy to do so should the need arise.”

Was that the first time there had been any mention of inflammatory bowel disease as far as you were aware, Doctor?
A As far as I am aware, yes.

Q Professor Walker-Smith thought that was unlikely. He arranged not to see him again, but we know that shortly thereafter, in January 1996, another consultant paediatric gastroenterologist became involved, and that was Dr Hunter at Addenbrooke’s. Would you go back to your GP records, please, at page 184. I am afraid it is very difficult to see the number. If you find 187 and work backwards, you should get to a letter to you ---
A --- from John Hunter.

Q Are you on the right page? This is a letter to you from Dr Hunter?
A With my note at the bottom, “Hunter Gastro SV, Addenbrookes”.

Q That is it, yes. Department of Gastroenterology, “Dear Dr Cartmel”. He starts off by saying:

“I am sorry that my previous letter to Dr Beattie was apparently not sent to you, I enclosed a copy.”

I am just orientating you. Would you now turn over to the next page, 185, which was his letter to Dr Beattie, which was enclosed.

“Thank you for asking me to see this young boy. Over the past years my main research interest has been in the role of food intolerance in the pathogenesis of gastrointestinal disease. It is clear now that food intolerance is extremely important in Crohn’s disease, and also in many cases of so called irritable bowel syndrome. However, these patients do not have food allergies. Our evidence suggests that there is abnormal fermentation of food residues by the bacteria in the distal bowel and that this is what leads to their symptoms.

In the course of this work I have encountered a number of children who have suffered abdominal symptoms associated with learning and behavioural disorders, some of which have been described as autism.”

He says he is aware of Dr Shattock’s work, and he says:

“I am, therefore, quite interested in [2’s] case, although I should stress that I would aim to improve his gut symptoms in the hope that his mental condition might improve pari passu rather than flattering myself that I have anything to add to his neurological management.

I think there are three possible matters that I might address here…”

And then he refers to the urine tests that have been done at the B12 unit, the possibility of celiac disease and he says that as he has never had a biopsy –

“I have sent off blood for endomysial antibodies. If there is any doubt I will do a biopsy under an anaesthetic.

Secondly, a number of these patients have benefited greatly from our standard exclusion diet which is nutritionally adequately balanced, but which avoids [particular foods]. …

Thirdly, a number of these patients show partial but not complete improvement on diet, although diet has become so limited as to be impracticable.”

He suggests trying bacterio-therapy. He then says, if he cannot gain any benefit he would return him to your care. That was to Dr Beattie. Then, if you turn back to your 184, he sent that letter to you, and we are now on his letter to you of 31 January 1996. He says:

“[Mrs 2] believes that her son has improved considerably on the diet which you gave him. In this situation one has to be very careful because mothers who are desperately trying to help their children will seize on anything as a sign of improvement, and it is very helpful if some objective assessment of the child could be made so that we can confirm that we are not restricting his diet unnecessarily.”

He in fact refers back to Hilary Cass, who was the lady who had assessed him in the first assessment that I took you to at the Wolfson Centre. He said:

“If there is no further improvement on his diet, he might be worth a trial of bacteria for these have helped some other patients considerably. However [Mrs 2] still has some further dietary”

and I cannot read that word –

“to do and I will leave a decision on bacteria until I see [2] again in 2 months time.”

We know after that – and this I want to ask you about carefully, Doctor, but Child 2 was seen again by Professor Walker-Smith. If you look in the Royal Free Hospital records ---
A Yes.

Q --- page 165.
A Yes.

Q This is a letter to [Mrs 2] from Professor Walker-Smith:

“I think it would be very helpful if I saw [2] again.”

I am sorry; I should say this is dated May 1996.

“I have had discussions about [2] with Dr Wakefield. We have a plan for investigation but I think if it were convenient for you, it would be helpful for me to see [2] first in the outpatients and discuss and plan what we have in mind.”

He arranged an outpatient appointment for 14 June 1996. Then he wrote to you about it, Doctor, and I will ask you a question about that letter in a moment. He wrote to you about it in the GP records at page 323.

“Dear Dr Cartmel”

This is dated 28 June 1996.

“I duly saw [2] in the clinic. As you know I first met [Mrs 2] via Dr Andy Wakefield who is concerned with measles immunisation and possible Crohn’s disease. I think that Crohn’s disease is unlikely. Dr Wakefield has the view that there may be some kind of other inflammation which may be a relevant factor in [2’s] illness and we now have a programme for investigating children who have an association with autism and a possible reaction to immunisation. I am arranged for [2] to come in for investigation at the end of August.”

Did you play any part, Doctor, in that situation coming about? We see that Professor Walker-Smith wrote to [Mrs 2] and he then writes to you, explaining to you what he is planning to do. Did you play any part in that arrangement?
A I would have read the letters, and thought, “Okay”.

Q You would have read this one, obviously, because it was addressed to you?
A Yes.

Q Would you necessarily have seen the one to [Mrs 2]?
A No. Well, I do not think so.

Q There is a note on that letter. Is that your handwriting?
A On which letter? The one ---

Q Sorry. The one I have just taken you to, 323, the letter that Professor Walker-Smith wrote to you.
A No. It was the chap who was my partner then who had noted it, probably for computerising as we were putting… We were still fund-holding then, so that may well have been an acknowledgement of a fund-holding bill.

Q We have a clinical note from you in September 1996, which is at page 233?
A Yes.

Q Is this your handwriting?
A Yes.

Q Can you just tell us what it says, the note for 23 September, please?
A I think it is 23 July.

Q Oh, July – you are quite right. It has been changed.
“Mixed messages flying around the school”

and to the GP and to Dr Hunter.

“The Royal Free are looking at this with MMR, and there had been an article in The Mail on Sunday provoking the Government into looking at this as the Royal Free believe this is a finding.”

Q This is your handwriting, not mine, doctor, but at the start of it, is it “The Royal Free are looking” or “linking this with the MMR…”?
A “… linking this with the MMR …”.

Q Where would that information have come from?
A Almost certainly [Mrs 2].

Q You tell us, and I understand this is a long time ago, and you tell us you have had a lot of conversations with [Mrs 2], but do you remember whether this was the beginning of you hearing about the link with behavioural disorders and the MMR, or had you heard about it prior to this?
A As somebody who does not read The Mail on Sunday as a routine….

Q Actually, you are right to pick me up, because I should have made the question clearer. I meant from [Mrs 2]. This is the first time you have mentioned to you or had it been mentioned previously?
A Because she has talked about it so much since then, I do not know whether this was the first time. I have not noted it, as far as I can remember, before that.

Q Do you remember ever having any conversation directly with either Professor Walker-Smith or Dr Wakefield in relation to their treatment of [2]?
A No. I do not remember doing so, no.

Q What was [Mrs 2]’s attitude to this particular issue, the issue of MMR immunisation and the possible link with enteritis and behavioural disorders, generally speaking?
A She felt that there was a case that needed to be answered.

Q Did you have any knowledge as to the nature of the investigations that Child 2 was going to undergo, except what was contained in that letter from Professor Walker-Smith?
A No.

Q In fact I think, ultimately, you had a discharge letter. That is page 341 of the GP records. This is a letter dated 16 September 1996 from Dr Casson, who was a registrar/lecturer in the department.

“[2] was admitted to our ward on the 2nd September 1996 for further investigation of several problems. The main problems are of developmental regression from 20 months of age, diarrhoea from 20 months of age and abdominal pain from the same period.”

Then there is a reference to his previous history – normal developmental progress.

“The diarrhoea started at this time, occurring 10 times a day and contained mucous. There was only one episode where it contained blood. There was also at this time indigested food in the stool.”

It sets out his history:

“Until 20 months of age … normal developmental progress. … Mum does recount that at 13 months of age he had had his MMR immunisation and 2 weeks following this had started with head banging behaviour and screaming throughout the night. He subsequently seemed generally sickly.”

Then he goes on to the diarrhoea and the symptoms that he had. Then he goes on to the next page, there is a sudden loss of weight associated with increased frequency of diarrhoea, general lethargy and pallor. Going down to the middle of the page:

“By this time several reported diagnoses had been made, specifically that of a specific language disorder and also other suggestions of Aspergers syndrome.”

He was seen by Dr Rolles and assessed for autism. At EEG had been taken under anaesthesia and he had become unwell following this. Once again, increased diarrhoea, decreased appetite, lethargy and increasingly withdrawn. Then his mother thought it might be due to B12 metabolism. He had attended the B12 unit. Then he said in summary –

“… his present condition is characterised by odd episodes which occur roughly every 18 months, the last of which was in April of this year. Mum also notes they can be associated with a jaundiced appearance and extremely pale stood.”

Then there is a family history. Then we go on to 343.

“He was extensively investigated. A full panel of blood tests was performed with regard to [his] developmental regression. He had a colonoscopy. He had an MRI. He had a sleep EEG and evoked responses. A Schilling test was performed.


Colonoscopy was performed under sedation. The rectum showed very minor abnormalities … without any frank ulceration … Overall appearances were normal until the ascending colon. Here one definite apthoid ulcer was seen and towards the caecum there were multiple prominent colonic lymphoid follicles. The terminal ileum also appeared abnormal showing marked lymphonodular hyperplasia though there was no ulceration. Histology possibly demonstrates mild chronic inflammation within the lamina propria of the terminal ileum. It should be noted that it is difficult to estimate whether or not this is within normal limits. … Throughout the large bowel there was a patchy increase in chronic inflammatory cells with an occasional prominent lymphoid follicle with a germinal centre. There was also an occasional focus of acute cryptitis within the ascending colon. There was also mild crypt distortion. …. The patchy distribution of this inflammation and the involvement of the terminal ileum are in keeping with a diagnosis of Crohn’s disease.”

There was a Schilling test performed. The MRI did not show any structural abnormalities. There was an EEG, which was within normal limits, although one frequency was a little low.

Then, going on to the next page there is a series of blood tests, cerebrospinal fluid tests, barium meal and follow through reported as being limited due to him having difficulty swallowing the barium but was normal. Several results still await. Significant finding of patchy inflammation within the colon. The significance of it…. That is irrelevant.

“In view of the colonic inflammation it was decided to treat him with an enteral feeding regime … This is a casein based formula with which we have had extremely good results in children with Crohn's disease. …

With regard to [his] neurological problems an opinion of a neurologist and a child psychiatrist have been sought. I am sure that they will forward further information to you.

We will review [him] in 2 weeks time. As with all children who start on … enteral feeding regime he will need a repeat colonoscopy after having been on the diet for 8 weeks.”

Q So was that the first information that you had as to the nature of the investigations that the child was undergoing at the Royal Free, Doctor?
A Yes.

Q Did you have any concerns in relation to what had been undertaken?
A At the time, no. The mother was there and was obviously monitoring things closely. I had no previous or actually subsequent experience of a child exactly like this. My immediate thought was that they were focusing on the one thing that they had found wrong as opposed to what was actually, to my way of thinking, that was the wrong with the child which was above the neck.

Q When you say the one thing that they found wrong?
A The fact that they had found that he had Crohn’s disease. I did not see it as an explanation for his cerebral problems, so I was watching with interest to see how it got there.

Q There was some indication of an improvement and if we look at the Royal Free Hospital records at page 120, we will see a letter to you from Dr Wozencroft.
A Yes.

Q This is a letter suggesting that there had been considerable improvement. Dr Wozencroft said, “I observed a striking change.” This is in April 1997. “He made eye contact twice in the course of an interview” and he sets out various other ways. “I have never seen 2 responding in such an ordinary way. Something has made a significant difference since our last interview and mother believes it is the medical treatment he has been receiving from the Royal Free. If that is the case, it would be a matter of great interest”. He sent copies to the Royal Free. He says:

“Like you I do not pretend to be an expert on the details of the metabolic processes involved but something has made a significant difference to 2.”

Were you in fact by that time in a position to make any assessment yourself? Were you seeing 2 at that point by April 1997?
A That was somewhere near the time he moved away, but I think I had still seen him. He was 9 then and again I was not convinced that he made eye contact or did not. He was looking around the room.

Q If I can just take you to a clinical note in the GP records which is shortly before that, in February 1997, at page 235 in the GP records. We see there that he had been starting on sulphasalazine. Was that a treatment with which you were familiar?
A Yes, though I do not know that I had ever seen it in a child this young.

Q What was it your understanding that it was a treatment for?
A He was being treated presumably for Crohn’s disease.

Q Was it your belief at that stage that the child actually had Crohn’s disease, as a result of the discharge letter?
A That is what the report said.

Q Then there is just one last letter, doctor, which is in the GP records at page 96. This is a letter you to you from Professor Walker Smith.

“I reviewed 2 in the out patient clinic with Dr Wakefield. Unfortunately 2 reached dramatically as far as behaviour is concerned to a number of food challenges. There was a particularly destructive behavioural response to maize bread. Also there was hyperactivity with ingestion of Liga rusks”

and various other foods are referred to.

“This child has had loose stools for some time and mother tells me he has loose stools most of the time.

Plain x ray of the abdomen showed generalised faecal loading and I am sure that constipation with overflow diarrhoea is contributing to his current diarrhoea. However, the situation seems fairly stable and I am not proposing any further medications.”

Then he refers to a dietary supplement. He recommends continuing on that. He says he stopped the anti inflammatory therapy. “... whilst it has initial therapeutic benefits, but now has no therapeutic advantage.” Then he says in passing that the plain x ray showed evidence of a spina bifida abnormality. He says:

“I don’t think this is a relevant clinical finding ... I will review in 7 weeks’ time i.e. off Salazopyrine and on this constant diet and we will then look at his future management.”

Is that correct?
A Yes.

MS SMITH: Sir, I see it is nearly 3 o’clock. You will appreciate it has been quite complicated following through this child’s history. There are two or three references I want to check before I finish with Dr Cartmel, so I wonder if this might be a convenient moment to have our afternoon break.

THE CHAIRMAN: Yes. We will now adjourn. Dr Cartmel, you are under oath and in the middle of giving your evidence, so during this adjournment, please make sure that you do not discuss this case with anyone.

(The Panel adjourned for a short while)

THE CHAIRMAN: Ms Smith, can I pass on a message from Panel members that they have asked me to convey? Although your pace of going through the evidence is much slower than Mr Thomas, they have found it pretty difficult this afternoon to try to absorb the information that has actually been given. They felt that it was a little too fast.

MS SMITH: I am sorry. I will try and go slower.

THE CHAIRMAN: In future, maybe you can get keep that in mind. This is the first time we are looking at all these things and sometimes we have to jump from one file to another. We have not seen any statement from any witness, so we have absolutely no idea what is coming our way.

MS SMITH: I will ensure that I go slower.

THE CHAIRMAN: Thank you.

MS SMITH: (To the witness) Dr Cartmel, you told us that Mrs 2 had discussed with you at length the possibility of the MMR vaccination being implicated in the child’s condition in some way. I asked you whether you could recall when that was or how early it was and you said you could not. I wonder if I could take you to the GP records at page 221?
A Yes.

Q You will see a reference in the middle of the records there on 2 November 1994.
A That is correct, and that is my handwriting.

Q It says “Discussed situations”; is that right?
A Yes.

Q “Nil obvious Re MMR story”.
A Obviously that was the first time.

Q It the first time certainly that we can find a mention in the GP records. Does it accord with your recollection that this was an early interest of Mrs 2’s?
A It has certainly been a great interest of Mrs 2’s. Whether it goes back 14/15 years ago, I cannot remember.

Q Would that note have come from a consultation with her?
A Yes. Almost all the consultations I had in the practice were with mother about child.

Q The other thing I want to ask you arising out of that was were you aware that there was the possibility of Mrs 2 litigating in relation to the MMR vaccination?
A I knew she had it in her mind at some time, but when that came up ...

Q Could I ask you to have a look at page 124 of the GP records, please. Do you have a letter from Drawbars Solicitors to Dr Maule?

THE CHAIRMAN: We have no paginated numbers, Ms Smith, so we are trying to find where we are.

MS SMITH: There is a clear number at 122, if that assists.

THE CHAIRMAN: Yes, I have found that.

MS SMITH: Do you have that, doctor?
A Yes.

Q It is a letter from Dawbarn Solicitors in November 1996 indicating that they are acting for two parents.

“Legal aid has been granted to enable us to investigate a claim for compensation following injury appears to have been caused by a vaccination”.

Can you help us as to who Dr Maule was?
A I have no idea. I wonder whether he was the subsequent GP looking after the child.

Q Could he or she have been the school doctor?
A In Lemington in Hampshire, could have been. The NHS does not tell us where a patient goes when their notes have been withdrawn from us. They simply withdraw them and that is it.

Q This was in November 1996, so you were still the child’s GP in 1996 were you not?
A But they wrote to Dr Maule and he was in Hampshire, so I wonder whether the child had actually moved from us about that time to his practice.

Q There are two letters to him in the GP records. There is that one. Then if we turn back to page 122, we see another letter from Dawbarns Solicitors indicating in the second paragraph:

“My firm is co coordinating claims by as many as 400 parents that their children have been seriously damaged by the MMR/MR vaccination”.

Do you see that letter at page 122?
A Yes.

Q In fact, if you turn back another page to 121, Doctor, you will see the mystery solved because this is the letter from Professor Walker Smith to Dr Maule. Do you see on the left hand side “school doctor”?
A Right.

Q It is clear that there was an involvement of solicitors at that time in 1996. Do you have a recollection of Mrs 2 discussing with you an intention to litigate?
A I have no recollection of that. But, as I say, that was a long time ago and I know that later on she has been talking about all sorts of cases and counter cases.

MS SMITH: Thank you, Dr Cartmel. Would you wait there, you will be asked questions.


MR COONAN: I have no questions, thank you.


Cross examined by MR MILLER

Q Doctor, I am mindful of what the Chairman said earlier about going through these documents, but I am afraid I will have to ask you about some of the letters in those various files. It will involve most of them. Please bear with me if we have to jump from one to the other.
A Yes.

Q The position, as I understand it, is that you were this child’s GP from October 1991 until he went to boarding school in XXX. Is that right?
A Yes.

Q There was a school doctor at the school after that, but obviously if he needed to be seen, or any aspect of his care needed to be discussed during the holidays, then his mother would come to see you. Is that right?
A Yes.

Q The position from April 1996 is that any note that has been made is on the temporary resident card rather than the Gladstone notes?
A Yes.

Q I do not think you insulted the child to say, as you do in your statement, right at the beginning that this was a very peculiar and unique child who presented with extraordinary problems, not only to his family but also to the various medical specialists and non specialists involved in his care.
A Yes.

Q Your first contact I think was when he was about 18 months old.
A That sort of age, yes.

Q I think by that time he had been immunised.
A Yes.

Q Because I think that was in the background when you first got to know him. As we saw earlier this afternoon, the first record of a perceived problem so far as development was concerned I think was in a letter from a health visitor, a Mrs Worsley, to the CMO at the local child development unit in Peterborough, which was in January 1991. Ms Smith went through those records with you. She refers you to Dr Dryburgh and Dr Dryburgh confirmed that at that early stage that the child had, in his view, a major problem.
A Yes.

Q You were asked about an entry which you made in the general practice records – I think it is in fact in the ordinary general practice records – about him not being autistic. It was a note of 11 October 1991, page 191. It says, “High level language problem. Not autistic”. You were asked about that by Ms Smith. She asked you where you got that from and you said you may have got it from the mother. In fact, I think Dr Dryburgh had written to the mother, copied to the general practice, in April 1991 at page 16 in the other bundle. The letter starts at page 14 and the relevant part is at page 16. This is a report in fact and we can see that copies go to Mr and Mrs 2 and Dr Myszka. Is that a name you recognise?
A He is a GP at a different practice in Peterborough and presumably that was his health visitor who did the original referral to Dr Dryburgh.

Q We can see she is the third one down in that list. What he says in the second or main paragraph which starts on page 16 is this:

“I also think it would be inappropriate to use autistic label given his attempts to communicate his needs to adults … ”

Et cetera. So somebody else has said that and that has been directed to Mrs 2, has it not?
A Yes.

Q As far as his gastrointestinal problems are concerned, we have the records going back to 1992 in the ordinary GP records at page 191. On 21 January 1992 we see, “Diarrhoea for a few days.” Then 26 March 1992, on the following page:

“Mum has noted loose motions have stopped since stopping bread and going over to rice.”

But then on 9 April 1992 at page 193, “Reverted to diarrhoea.”
A Yes.

Q There is a detailed report from Dr Hilary Cass which is in the additional general practice records at page 26. Do you have that?
A Yes.

Q This is something of a baseline report, is it not? Is the Wolfson Centre part of Great Ormond Street?
A I had assumed so.

Q It seems to be a multi-disciplinary report, but put together by Dr Cass and Katy Price, a speech therapist. There is quite a detailed discussion about this child’s problems going on to page 28, where Dr Cass says:

“On the basis of history, he is most like a group of children who progress normally until 20 months of age, when they undergo an autistic-like regression. There is often a family and/or personal history of allergy, and indeed, 2 has both. Most of this group seem to have some spontaneous recovery at 3½ to 4 years, often with a good eventual outcome, although they continue to have social communication problems.”

Did that report come about as a result of a referral which you made?
A It must have done, but I am not sure to whom. Mother had asked for her to be sent to the Wolf Centre, but offhand, I cannot remember how that letter got there.

Q It was a referral for an assessment and this is the response.
A Yes, to Professor Neville.

Q He is based at Great Ormond Street, is he not, or was?
A I assume. Presumably Dr Cass was his senior registrar.

Q We have a note in the general practice records, just tying this in, dated the following day, 14 April 1992, from you, which we have seen, in which you put “Allergy induced autism”, which I imagine reflects the fact that somebody else has made that diagnosis, if it is a diagnosis.
A Yes.

Q On the following page, just to deal with the gastroenterological side, at page 195, on 16 June the note is that the child still has diarrhoea.
A Yes.

Q Dr Cartmell, in your statement you say that as a GP without specialist expertise in this area, you did not understand Child 2’s illness and you were therefore prepared to refer him to any reasonable clinician that his parents asked you to. This is not in any way a criticism, but that was the position that you found yourself in, was it not, in this very peculiar case?
A Yes.

Q So, as we have seen, you referred him to a number of different specialists, mostly in what might be regarded as prestigious medical centres: St Bartholomew’s Hospital, Professor Davies; Southampton, Dr Rolles; Birmingham; Chelsea & Westminster. All well-known centres, centres of excellence.
A Yes.

Q As we know, you also referred him in March 1995 to a local psychiatrist, Dr Wozencroft.
A Yes.

Q That referral came about in a slightly unusual way, because the referral to him came through Dr Tuck, a local paediatrician. There was dialogue between them and Dr Tuck said, “Would you see this child?” and then I think Dr Wozencroft wrote back to him, saying, “Yes, I will, if the GP wants me to.”
A And I said ---

Q “Please do”.
A Yes. I think my feeling at the time was that the person who was most of an expert in Child 2 was Child 2’s mum and I knew far less about him than she did. At the same time, because we were involved with fund holding, I needed to know a little bit more about why I was asking him to be seen where he was seen. That was, if you like, just to get a little bit more control over what was going on.

Q You have explained that you had a certain amount of lead, but there might come a time when other people were going to have to pay for it and therefore you wanted to make sure that you were acting within your remit.
A Yes.

Q I think there is a letter somewhere – we do not need to turn it up – saying, “I think we are all right so far. At least, there hasn’t been any concern about referrals so far, but we will keep an eye on it.”
A Yes.

Q That presumably was something which was in the back of your mind, because you cannot just refer and refer for no reason.
A It was also the fact that I was working with two other practices who may have had different views as to large amounts of expenditure on one person.

Q This was your patient and you had to share around.
A Yes.

Q Can I just ask you to turn to page 93 of the additional records, just to deal with the point of the referral? This is a letter from Dr Wozencroft to Dr Tuck, Dr Tuck having asked Dr Wozencroft to become involved. This is Dr Wozencroft’s reply to Dr Tuck:

“I am prepared to see 2. I am not sure from the correspondence whether Dr Cartmel wants a psychiatrist or whether in fact only a paediatrician will do. I note that Dr Dryburgh has been involved in the past.

If Dr Cartmel and you feel that I am a suitable person, I will offer 2 and his family an appointment. I will take no action until I hear about the lad again.”

You get a copy of that letter. As between consultants, there has been some discussion. He says he is prepared to do it if you want it and it is up to you then to say, “Yes, thank you. Would you please see my patient?”
A Yes.

Q From there, at that time in 1995 – I do not want to go through every single step of the way – Dr Wozencroft, the consultant, refers Child 2 to Professor Walker-Smith.
A Yes.

Q As I say, there are several other people whom I have not bothered to deal with, but I am just trying to see how these referrals get to Professor Walker-Smith. At that stage, he was still at Bart’s. Again, in that same bundle at page 101, he passes the ball on. This is a letter of 29 June 1995 and again, this is consultant to consultant:

“I write to ask you to see 2 and to express an opinion upon him. I know that his parents have contacted you and your colleague, Andrew Wakefield. The family doctor … also wants the benefit of your opinion.”

Ms Smith took you to an undated document in the local health records in which I think first there is a communication noted of you I think on the Monday to Dr Wozencroft and then on the Wednesday Mrs 2 also asking for this referral. So there must have been some discussion about a referral to Professor Walker-Smith at Bart’s, but the actual referral in this case comes from consultant to consultant.
A Yes.

Q Because you are the GP, even though the referral has come from the consultant, you receive a letter from Professor Walker-Smith, which is at page 113. This is a letter dated 13 September 1995. Whether you were expecting it or not, it did not surprise you to receive a letter from Professor Walker-Smith, because that had been the intention of Dr Wozencroft which you knew about.
A Yes.

Q He says:

“… I think inflammatory bowel disease is extremely unlikely and I have had a copy of a letter which Dr Bhatt wrote to you and I do believe that the best way forward is for a Schillings Test.”

You were asked if this was the first reference to inflammatory bowel disease, but at this stage this was the first reference to the department of paediatric gastroenterology, was it not?
A As far as I can remember, yes.

Q I think we have been through neurologists, paediatricians, psychiatrists and in due course we will come to Dr Hunter, who is an adult gastroenterologist, is he not?
A Yes.

Q But this is the first one involving a paediatric unit. I am going to come back to Dr Bhatt in a moment briefly. He is writing back to you saying:

“… I do believe that the best way forward is for a Schillings Test. This is a test which is best done by experts and I would recommend that this is done in Chelsea & Westminster. However, I do think it would be very helpful if a paediatrician could be involved locally and I have suggested that Dr Mark Beattie recently appointed consultant paediatrician in Peterborough …

I have not arranged to see 2 again but I would be happy to do so … ”

That is a letter which does not appear to solve any problem, but suggests that it would be better if things were done locally as far as the overall management, which of course you had been trying to get for a number of years.
A Yes.

Q But Dr Beattie was suggested and you took up that suggestion, did you not? He suggested that as far as this particular test was concerned, that should be done at Chelsea and Westminster.

“I have not arranged to see [2] again but I would be happy to do so should the need arise.”

You would not have known, but a similar letter, as you might expect, was written to Dr Wozencroft, who had been the referring doctor. You would expect he would write back to the referring doctor as well, in which substantially the same thing was said, although he also said, “I have left the lines of communication to [Mrs 2] open”, even though he had not made an appointment. In broad terms, he is saying that is what he is going to do, or that is the position. So another referral at that stage, not much positive coming out of it?
A No.

Q But another consultant had been suggested, and he was duly seen – or at least his case was seen, I think by Dr Beattie, who referred him to Dr Hunter who, as you have said, a gastroenterologist, local, but an adult gastroenterologist. Dr Beattie’s letter to Dr Hunter – can we look back at the original GP records, please, at page 302. It is a letter of 20 November 1995. I do not think it is unfair to say it is a familiar refrain. It is a letter from a consultant to another consultant saying, “I would be grateful if you could give me your assistance about this child,” although, in fairness to Dr Beattie, he is concentrating on the gastroenterological side rather than any other side, is he not? He has referred him to a gastroenterologist, albeit an adult one. Dr Beattie also wrote to you on 20 November, on the following page in that bundle?
A Yes.

Q So it is on the day of the referral to Dr Hunter. He writes:

“Dear Dr Carmel,

I met with mother and [2] on 1st November. She is concerned currently that his diarrhoea has increased and that his behaviour has deteriorated and that he is in pain.”

He explains that he went through the tests that he had done, which appeared to be normal. He refers to Dr Bhatt, who was at the Chelsea and Westminster Hospital. In the final paragraph he says:

“We did again discuss [2]’s diagnosis and I have said to mum that we should in our correspondence with others, say that he had autistic spectrum disorder with possible allergic induced component.”

So he has passed it on to somebody else, albeit he is telling you what his discussions were, and what his findings were. Again, that is something which we have seen throughout the correspondence – people examined 2, but came to no particularly clear idea about how they were going to deal with the future.
A No.

Q You did look at a letter in the general practice records, so not the additional, at page 185. This is where I think it was difficult to identify the page numbers. If you go to 187 and then go back ---
A 3 January 1006?

Q Yes, that is right. This is Hunter to Beattie.
A Yes.

Q Reporting. Having taken the referral, consultant to consultant, and reporting back on his findings. He starts in that letter by saying:

“It is clear now that food intolerance is extremely important in Crohn’s disease, and also in many cases of so called irritable bowel syndrome. However, these patients do not have food allergies. Our evidence suggests that there is abnormal fermentation of food residues by the bacteria in the distal bowel and that this is what leads to their symptoms.”

Just going to the last paragraph on that page, Ms Smith did not read it all to you. She jumped over a part of it. I think we should go through it.

“I think there are three possible matters that I might address here. I understand that excretion of methylmalonic acid in the urine performed at a reputable hospital in London suggested that he has B12 deficiency and he has since improved on B12 injections.”

That is reference to the investigations that have been carried out at the Chelsea and Westminster, is it not?
A Yes.

Q Dr Bhatt and Dr Cavanagh.

“This obviously raises the possibility of coeliac disease, and as he has never had a biopsy I have sent off blood for endomysial antibodies. If there any doubt I will do a biopsy under anaesthetic.”

What did you understand a biopsy under anaesthetic to involve?
A I had understood, certainly when they do it for adults, it would be a Crosby capsule; they swallow the capsule and it is done. I guess for a kid this young, he may actually need to be sedated.

Q It says “under anaesthetic”. It could equally well be a colonoscopy or endoscopy of one sort of another to get a biopsy from the gut?
A Yes.

Q He is talking about getting ---- I am sorry. I should have started with this: the biopsy from the gut is what we are talking about, is it not?
A Yes.

Q If there is any doubt. Then he goes on to deal with the dietary exclusion point and how you measure this. Otherwise, if they do not manage well on the diet, then you try a healthy probiotic bacteria administration, to see if that is going to do the trick. What this doctor, Dr Hunter, is saying is that it may be necessary to do a biopsy; there are other alternatives involving diet, or actually giving the child bacteria to improve his bowel symptoms. It is clear that Dr Hunter, anyway, was treating these bowel symptoms as serious?
A Yes.

Q And I think by that stage they had to be taken seriously, did they not?
A Yes.

Q Professor Walker-Smith had suggested that the child might benefit from a Schilling test, but also suggested it would be better done in London, where he had been before, rather than at the Royal Free Hospital, so Chelsea and Westminster rather than the Royal Free. But I think that there was a bit of a dispute, was there not, with Dr Bhatt at the Chelsea and Westminster?
A The problem that we had at the time was that I wanted him to talk to me.

Q Yes. He did not answer your calls or –
A He did not answer any of the calls. As you can tell from one of the letters there, I got fairly shirty and in fact over a telephone call it became ----

Q I put it as neutrally as I could that there was a bit of a dispute. It is charted in the notes?
A Yes.

Q There was a dispute. The Chelsea and Westminster fell out of the picture, I think, at that stage, and the Schilling test was never done, was it?
A As far as I know, no.

Q There was a bit more correspondence with Dr Hunter, but you then got a letter from Professor Walker-Smith in June 1996, so about six months or so, or five months after the correspondence with Dr Beattie and Dr Hunter, in the original general practice notes at page 164.
A June 1996, 164.

Q Yes. June 1996 is 164. I have tried as much as I can to try and keep in the records which you would have seen in the general practice, but we all have access now to the other now. I was looking really to the correspondence. This looks as though it has come from the general practice file. It is dated 28 June 1996. It has written in handwriting “Forum School”, and that was the school to which this went, was it not?
A Yes.

Q It also has “Gastroenterology (Royal Free) – Send letter on to where moved to”. That suggests that by then he had moved to school and under a different jurisdiction?
A Yes.

Q Because you said that is not your handwriting?
A No, although that is the handwriting of the chap who was then my partner. So the letter had arrived in the practice ---

Q Exactly so.
A --- and we copied it and sent it on.

Q I will come back to that in a minute. Taking things generally, this letter is another letter. The last one you had was in 1995. He says that he has seen him in the clinic, and he explains that he first met [Mrs 2] via Dr Wakefield, and the circumstances in which he met him, and explains that Dr Wakefield has the view that there may be some kind of other inflammation which may be a relevant factor in 2’s illness. They now had a programme for investigating children, who have an association with autism and a possible reaction to immunisation.

“I am arranging for [2] to come in for investigation at the end of August.”

You were also shown, for the purposes of this hearing, a letter that [Mrs 2] received from Professor Walker-Smith at about the same time. I think hers was 16 May 1996, which is not in the GP records?
A No.

Q You say in your statement that these letters indicate to me that at some point Child 2 was referred back to the Royal Free Hospital for investigation.

*“This must have happened indirectly as a result of the earlier referral to Professor Walker-Smith who then moved to the Royal Free from St Bart’s. It is possible that [Mrs 2] persuaded Professor Walker-Smith to see the child despite the content of his earlier letter of 13 September.”

*Citation unchecked; document not available to shorthand writers.

That is your reconstruction of the events?
A It was a guess.

Q But it had not come through you, but of course he had been there the year before – nine or eleven months before, eight months before – and he had gone back. You could quite see that it may have been Mrs 2 that had got back in touch to say, “Will you see the child again?”
A It certainly would not surprise me.

Q And to some extent that looks a likely scenario, given the pattern of earlier referrals to various different people in the past?
A Yes.

Q And the original referral to Professor Walker-Smith had, of course, been by Dr Wozencroft, not you. So we have reached the position in the summer of 1996, it looks from that letter, what is written on it, that it is by then the child has moved away from the area, certainly during the term. That would mean that his day to day care would be in the hands of the doctor nominated by the school?
A Yes.

Q We have reached the stage, Dr Cartmel, that quite frankly you were not at all worried that he was going to be admitted for tests to the Royal Free Hospital because somebody was showing an interest in dealing with him, and investigating him?
A And also because his mother was in favour of it.

Q Yes. I may have been oversensitive, but I detected in the questioning from Council for the General Medical Council invitations to you, Dr Cartmel, to tell the Committee that Mrs 2 was making your life difficult, and that she was being unreasonable in her quest to try and find out what was wrong with her child.

MS SMITH: I do object. That was not ever expressly suggested by me at any stage. If Mr Miller is asking a question, it seems to me to be the most curious preface to a question because Dr Cartmel can only answer the questions that are put to him.

MR MILLER: I just ---

THE CHAIRMAN: Just one second. Legal Assessor, let us have some light on this.

THE LEGAL ASSESSOR: It is not for this witness to assess any implication of the questions that were not direct questions to him. So what was in Ms Smith’s mind, or any insinuation that Mr Miller interprets her as making, is not a matter for this witness. He can answer direct propositions put to him by Mr Miller.

MR MILLER: That is exactly what he is being asked.

THE LEGAL ASSESSOR: But not about Ms Smith’s insinuations.

MR MILLER: He was not being invited to say that. He was being invited to say whether or not, if that is being insinuated, that was correct.
A This was a mother with three children, with the middle child who was consuming a great deal of her time and concern. I could not put myself in her position without it being a fairly horrendous position for her to be in. She was looking for an answer, so I did not think it was unreasonable. I just could not answer her, and trying to find somebody, perhaps who could was something I was quite keen on too. A miracle cure would have been wonderful.

Q It was worth a try to see if anybody could do any better ---
A Yes.

Q --- than up to that point. What you have after those investigations, which were being carried out by a specialist paediatric gastroenterology unit at a London teaching hospital, was a really detailed letter from Dr Casson – the letter which you looked at earlier on?
A Yes.

Q In which it was suggested that there was a provisional diagnosis of Crohn's disease. Coming from a specialist unit, you took that as being their best guess as to what was wrong on the gastroenterological side?
A Yes.

Q I think just the GP records at page 351, there is a short letter of 4 October 1996. So by that stage you get the discharge summary on 16 September, or it is dated 16 September, so a couple of weeks later, there is a letter from Dr Fell attached to the same department:

“Child 2 is responding very well to a course of enteral nutrition for his inflammatory bowel disease. He is taking a polymeric diet of greater than 2 litres per day and is gaining weight. We will see him as an inpatient in 5 weeks time for an endoscopy for reassessment.”

Sent to Dr Beattie, who was the local paediatrician still looking after him, but copied to you. Do you see that?
A Yes.

Q And in due course – and it is the only time I want to ask you this – please look at the local health records, the LHR records, at page 143. It is a letter from Dr Wozencroft to you in April 1997.
A Noticing a striking change in him.

Q Exactly and saying,

“I have never seen 2 responding in such an ordinary way. Something has made a significant difference to him since our last interview. Mother believes that it is the medical treatment he has been receiving from the Royal Free”.

Doctor Cartmel, it looks as though some letters were still coming to your practice?
A Yes.

Q Although if we went through, and I am not going to do it with you, the additional records, it is clear that a lot of correspondence is going to Dr Maule, the school doctor, and also subsequent to that Dr Thomas who took over, but there is correspondence following out patient reviews and discussion about treatment with Dr Maule, which would not have concerned you, going forward in time for a number of years after this reference here. You received letters as late as 2004. Is that right?
A I believe that is true, yes.

Q From the Royal Free telling you about a particular treatment or investigation?
A Which was from time to time quite handy as mother has remained to date still my patient and has discussed what is going on.

Q As to what the objective outcome is, other may have to say, but this is at least a unit that has stayed on the case from the time that he went back to be investigated in 1996?
A Yes.

Q And have kept the general practice, whichever one it was, informed at every stage as to what they were doing?
A Yes.

MR MILLER: Thank you.


Cross examined by MR HOPKINS

Q Good afternoon, Dr Cartmel. A couple of documents that you have not been shown this afternoon that relate to a time just before or around the referral of Child 2 to the Royal Free. Can we look at the local hospital records at page 106 to begin with?
A The re assessment summary.

Q Indeed. If we turn on to page 108 we will see who this comes from. It is a letter from Dr Hilary Cass. By now she is a consultant in paediatric disability. We see that you are copied into this letter, as are others involved in Child 2‘s care including the parents. If we go to the front page, you will note that, or at least, I cannot see a date on there, other than a date stamp towards the bottom right hand corner that is indistinct on this photocopy. From other records we believe it is 28 July 1996, but the context will become apparent in a moment.
Can I take you to page 108? This is the last page where Dr Cass a saying a quarter of the way down,

“This pattern of ongoing regression is not one which is normally observed in children with autism even among the group who have an early loss of skills in the latter half of the second year. The expected course for children with autism (including those children in whom there is good evidence of food allergy) is one of continuing progress, albeit with some periods of more rapid development being interspersed with plateau’s and periods of minor behavioural variability. In the light of this situation it now seems important to investigate 2 for the full range of neurodegenerative conditions, and I have therefore arranged a joint appointment with Dr Robert Surtees (neurometabolic consultant at GOS) and myself on 22nd August”.

You are being informed or kept in the loop?
A Yes.

Q And that this child is going off for a joint assessment to Dr Surtees to Great Ormond Street. Can we just pick up the story from Dr Surtees’s point of view? For this, you will need to go to the Royal Free bundle. If you could turn to page 153, please. There we see a later dated 23 August attest to Dr Cass. If we turn to page 154 we see it seem from Dr Surtees, who is described as senior lecturer in paediatric neurology. This letter was copied into the parents as well as to yourself and others. Is that right?
A Yes.

Q You will see from the context this helps date the letter that we were looking at from Dr Cass. If we can just read through it please. Back to page 153,

“Thank for you letting me see this eight year old boy who now has the features of a child with classical infantile autism. What is unusual is that there have been three episodes of regression each proceeded by some months of increased activity and misery. Following each episode of regression he has never regained the skills lost. On formal neurological examination there are no focal findings. I am afraid that I do not recognise this as a defined neurometabolic or immunological disorder. However, I do think reinvestigation in necessary if only to make an authoritative decision on what he does not have. To this end, I would suggest the following investigation:

1. Magnetic resonance imaging of the brain including specific temporal lobe views
(I am sure that this will need to be done under a general anaesthetic that sedation alone will not suffice)

2 A repeat EEG with a drowsy or sleep recording.

3. Repeated metabolic investigations”....

4 Detailed immunological investigations looking both at T and B cell function, an auto antibody screen and an immunological consultation.

5 A detailed dietary review.
6 A gastrointestinal consultation.

I understand that further investigations are being proposed and it would clearly be economic of the above could be combined with these”.

Just looking at that letter, you are being informed, are you not, by Dr Surtees that there is a need for a further series of investigations to work out either what the child has or to exclude what he does not have?
A Yes.

Q This recommendation comes shortly before this child is admitted to the Royal Free?
A Yes.

Q I need not trouble further with those documents. Can I just look at a separate aspect and that is what happened after the child had been investigated at the Royal Free. To take you then back to the GP bundle, if we may. I am anxious to go to a few documents concerning follow up care. If we can go please to page 45 of the GP bundle. Do we there see a letter dated 26 August 1999. If we turn over the page we see it comes from Dr Simon Murch and the letter is copied into you concerning Child 2. Is that right?
A Yes.

Q Just going back to the front of this letter, page 45, the diagnosis that is being listed there:

“Autistic spectrum disorder.
Intestinal inflammation with associated motility disturbance.
Partial response to dietary exclusions.
Recurrent severe constipation”.

Then if we just look at the information that is being relayed here in the next paragraph, there is the reference to Child 2.

“He has not really shown significant improvement while on E028 apart from a brief period when this was first commenced with a few foods diet”.

If we just go down a few lines,

“However, I suspect the underlying problem has been constipation”.

The next paragraph,

“His abdominal x ray was grossly loaded with mega rectum. I do think it would be most for Child 2 to tack this effectively. On a broader front I am concerned that he has lost weight, and I think, on balance, he would be better to return to the polymeric formula MODULEN IBD which is not only of higher calorie density but enriched anti inflammatory molecules”.

Just pausing there, this letter is addressing the child’s nutrition as well as the anti inflammatory properties of the formula. Is that right?
A I suppose.

Q If we turn the page, we see in the second line down,

“There is undoubtedly a minor and probably secondary disturbance of pancreatic function in relation to the gut inflammation of autism”.

So, again, a view being expressed that this child is suffering from inflammation of the gut. Is that right?
A Yes. What I am interested in is who the letter was actually written to.

Q We see that you are being copied into it.
A Yes.

Q And indeed that the mother is being copied into it?
A Yes. But I would have assumed this being three years after the child has left my list that I have been copied in as somebody who might see him while on holiday.

Q I am not suggesting that this was for your ongoing management day in day out; I am just looking at correspondence that you have received and the information contained in it.
A Yes.

Q If we can then turn to page 31, do we there see a letter dated 23 February 2001? We can see that again comes from Dr Murch, this time directly addressed to you. If we look at page 31, again under the “Diagnosis” section halfway down,

“Regressive autistic spectrum disorder with gastrointestinal symptoms.
Ileo colonic lymphoid hyperplasia and low grade colitis.
Chronic constipation and recent deterioration”.

Then we see in the paragraph below it that Dr Murch is informing you that, unfortunately, the child slipped back a little in the last few weeks and that appears to be related to the current constipation. He says,

“In his case this is often manifest by behavioural disturbance, increased toe walking, face pulling and dark rings under his eyes”.

He does he go on to deal with the medication of liquid paraffin and towards the bottom of the page three or four lines up,

“He remains on Nalcrom 4 times daily, Sulphasalazine elixir 5 mls twice daily and rather large dose of enteral nutrition supplement with 200 mls of Modulen daily.”

Then he makes a recommendation about that.

If we move on to see the next correspondence and follow up from Dr Murch page 9 of the same bundle, there is a letter that is clinic dated 16 April 2004 addressed to you again from Dr Murch, halfway down the page again informing you of the diagnosis:

“Autistic spectrum disorder, low grade colitis, recent onset of epilepsy” and points out that it is first time that he has reviewed Child 2 in three years. He then goes on to say in the next paragraph, “From a gastrointestinal viewpoint, things have generally improved. He has had fewer problems with constipation than in the past, and he has stabilised on his therapy of Sulphasalazine 5 ml BD (250 mg), MODULEN, IBD supplements 400 mls daily, and Liquid Paraffin 5 ml BD. I thought his examination was very satisfactory today and there was no evidence of significant faecal loading at all which is a contrast to the past.”

Then he goes onto make mention of the seizures and the fact he is due to see a paediatric neurologist.

Then over the page, here is pointing out, is he not, that the child is on quite a low dose of Sulphasalazine for his weight and,

“... We need to be guided by his current inflammatory markers whether this should be increased. As it is a long time since you have seen him, I have taken a look in more depth at his current status and I am including some micronutrients and basis immunological test in addition to the inflammatory markers. Despite his dietary restrictions, he does appear to be well nourished and I think the MODULEN IBD is likely to be helping with this. Overall, from the gastrointestinal viewpoint, I was very satisfied with his progress today. I suggest that we see him in 6 months routinely”.

Then he sets out, does he not, the results of the various tests that he had set in place?
A Yes.

Q Again, keeping you informed as to this child progress and indeed improvement in his gastrointestinal condition?
A And should I see him during a school holiday, I would have information there that makes sense if I was asked to prescribe something.

Q The final document I wish to refer to, it is not in this bundle. Can we go back to the Royal Free bundle please? If you turn to page 48 in that bundle, do we see there a letter again from Dr Murch to yourself with a clinic date of 27 October 2004?
A Yes.

Q Again halfway down, the problems are listed, there are three:

“Autistic spectrum disorder, low grade colitis, and epilepsy”.

Dr Murch reports that he has reviewed Child 2 in clinic.

“In general things are stable from the gastrointestinal viewpoint and I have recommended no change from his current therapy of Sulphasalazine 5ml bd and enteral nutrition supplementation with Modulen 400 ml daily. His growth has been excellent and his constipation has been kept under control.”

Just pausing there, again it seems that a snapshot is, from the gastrointestinal point of view, things have again remained stable and are progressing satisfactory. Would that be fair?
A Yes.

Q The next paragraph,

“Child 2 has received additional treatment with injections of methyl vitamin B12, following a consultation with an American team, and he has appeared calmer since having these. I think this area is beyond my expertise but I will be interested to hear whether he maintains his improvement.”

Then the last paragraph on this page reads,

“We will be happy to maintain him under gastroenterological follow up while he remains in the paediatric age group”.

Just pausing there, in fact he is aged about 16 at the time of this letter.

A Yes.


“It will be, ideal if possible, to find an adult gastroenterologist who would be happy to take on his care beyond this stage, as Child 2 does indeed have ongoing gastrointestinal issues.”

Has in fact happened; has an adult gastroenterologist been involved to your knowledge?
A I have no idea.

MR HOPKINS: Thank you.

Re-examined by MS SMITH

Q I have just two short matters, you will be pleased to hear, Dr Cartmel. First of all, could I ask you to look in the GP records at page 194? Do you remember, this is an entry which I took you to where there is a reference in inverted commas to “Allergy induced autism”.
A Yes.

Q Mr Miller suggested to you that that was a diagnosis. I wonder if I could just ask you to look in the records again at page 28? It is the end of Dr Cass’ report. If you look at the top of the page, in the second paragraph down, you see:

“In view of 2’s history and his possible food allergy, we have suggested that Mr and Mrs 2 contact the Allergy Induced Autism Group.”

It would appear that that is some sort of organisation for sufferers. Is that correct?
A I know nothing about that particular group at all.

Q The other matter was that you may recall you were taken to a letter by Mr Miller from Dr Hunter, the gastroenterologist, and Mr Miller put to you, as was indeed the case, that there was a suggestion there by Dr Hunter that he might consider a gut biopsy. Do you recall that?
A Yes.

Q Could I just ask you to look at GPR, page 184, please? This is a letter which we looked at before to you from Dr Hunter. What I did not read was the third paragraph, which says:

“For the record his gliadin antibodies are negative, making it extremely unlikely that he has celiac disease and I don’t propose to put him through a duodenal biopsy.”

Do you see that?
A Yes.

Q Could I also ask you to look at the Royal Free Hospital records at page 155? This is a letter in fact from Dr Hunter to Professor Walker-Smith, so you will not have seen it. If you look at the second page of that, you see that Dr Hunter says to Professor Walker-Smith:

“I have understood from Mrs 2 that 2’s guts are greatly improved when he sticks to his diet and his bacteria, and I personally would have been reluctant to do a colonoscopy.”

So it would appear that Dr Hunter did not in the end think that course was appropriate.
A Yes.

MS SMITH: Thank you very much, Dr Cartmel. I have no further questions, you will be pleased to hear, but the Panel may have some.

THE CHAIRMAN: It is now 4.40 and we need to look at our own notes. Therefore I do not think it will be possible for us to release you, Dr Cartmel. Is it possible for you to be here tomorrow morning?
A I would have to go back to Peterborough tonight and I suppose coming back tomorrow morning would be possible, if necessary, but if it could be avoided, it would be appreciated.

THE CHAIRMAN: It seems that we probably do not have any questions. If we do not have any, then obviously you will not be able to come back with any matters of clarification. Can I in that case say thank you, Dr Cartmel. You are now going to be released. Thank you very much for coming to help this Panel.

(The witness withdrew)

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

(The Panel adjourned until 9.30 a.m. on Friday 3 August 2007)

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