Thursday, February 2, 2012

Day 36 GMC Fitness to Practice hearing for Andrew Wakefield



Friday 28 September 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, contd 1

THE CHAIRMAN: Good morning, THE CHAIRMAN: Good morning Professor Rutter. Good morning to you all. Ms Smith?

Examination in chief by MS SMITH contd.

MS SMITH: Professor Rutter, I had finished the questions I wanted to ask you about the first child in the order of admission to the Royal Free, and I am now going to turn if I may to the second child, who is somewhat confusingly Child 1, and that is at page 12 of your report.

The Panel will need the general practice notes for a couple of references and the Royal Free notes, yes. I am going to follow the same format, Professor Rutter, by going through the circumstances in which the child was referred to the Royal Free first, and the first letter is from the mother of Child 1, handwritten, in the GP records at page 125. This letter has been slightly cut off in the photocopying but I think we can see enough of it to understand its relevance. It is a letter to the GP:

“Dear Dr Haughton,

I would like you to refer my son [Child 1] to the below address immediately” – and then we see the words – “a severe metabolic disorder and needs tests done …”

And then the address of Professor Walker-Smith at the Royal Free.

Turn, please to the Royal Free Hospital records. The GP records can be put on one side for the time being. At page 56 we see the actual referral letter – that is the official page of it – dated 17 May 1996 requesting an appointment from Professor Walker-Smith and giving all the patient details, and then if you turn on to page 57 you will see the reasons for referral:

“I understand that [Mr & Mrs 1] have contacted you regarding their youngest son [Child 1] who has been diagnosed as autistic.

[Child 1] initially developed normally, reaching the normal milestones until he was about 15 months old. He then regressed and has now been diagnosed as autistic; his elder brother [name] is also autistic.

[Mr & Mrs 1]’s most recent concern is that the MMR vaccination given to their son may be responsible for the autism.

We do not have very much correspondence regarding [Child 1] but I have photocopied any relevant information that is available.

I would value your opinion regarding this challenging family.”

Attached to that letter was a letter from Dr Hauck, who is a consultant psychiatrist in learning disabilities, and that is at page 58. It is dated March 1996, so a couple months prior to the referral:

“On 7.3.96 I met [Mrs 1] at some length at the XXX ... Initially, the concerns reported to me were that [Child 1’s] sleep caused many problems. As on previous occasions, the conversation ranged widely. It gradually emerged that [Mrs 1] is much exercised about [Child 1’s] eating; he is choosy and a slow eater and she feels he is not adequately nourished. He suffers from loose stools on most days, she tells me. From the Autistic Society she has received information about the benefits for some children of a casein-free and gluten-free diet. She feels she would like to try a diet before considering any other interventions. I suggested that I would contact the dietetic service and ask for help, but also advised that a period of observation and recording of symptoms she hopes will improve with the diet would be useful, before beginning the diet.”

There is then a reference to their personal circumstances, and a plan to meet again in April.

That was the letter from the psychiatrist.

Just turning back to the referral letter from the general practitioner, given that this is a referral to a paediatric gastroenterologist, is there anything striking to you in relation to that letter from the GP?
A Well the thing that is most striking is it makes no mention of any gastroenterological problem.

Q If this had been a clinical referral, as it is suggested it was, is that what you would have expected?
A No, because to refer to a gastroenterological service a child in which the only mention is made of autism seems very unusual. It is not unusual, of course, in relation to the plan to look at the conjunction between the two, but that was not evident at the time of referral.

Q Again, I am sorry if this is a rather obvious question but if for some reason – it does not appear to be apparent from the referral letter – a GP felt that a neuro-psychiatric assessment was necessary, particularly in relation to any possible degenerative disease, would you ever expect a referral to a paediatric gastroenterology service?
A That would be very unusual. That would be peculiar. Obviously, all medics have to have a range of expertise beyond their own specialty, but you would not refer to someone where this is peripheral to their main interest and main practice.

Q We know there was an outpatients appointment with Child 1, and then Professor Walker-Smith wrote on 21 June, and that is at page 54, to the GP:

“Many thanks for referring [Child 1] with autism. It is difficult to associate a clear historical link with the MMR and the answer to autism although [Mrs 1] does believe that [Child 1] had an illness 7-10 days after MMR when he was pale, ? fever, ? delirious, but wasn’t actually seen by a doctor. Between the age of 1 year and 18 months his development slowed and then deteriorated. It is very interesting that he has a 5 year old brother who also has been diagnosed as part of the autistic continuum. As part of Dr Wakefield’s and mine interest in the relationship between immunisation and chronic inflammatory bowel disease, I have arranged for routine blood tests to be done for screening for C-reactive protein, et. The diarrhoea which [Child 1] currently has does have the features of toddler’s diarrhoea. His mother is concerned by the diarrhoea. Loperamide in a dose of 2mgs twice a day could be tried therapeutically. She was concerned that this could have an adverse effect on his neurological development, I am not aware of Loperamide ever having such effects, its only side effects that I am aware of is some abdominal pain and skin rashes occasionally and in children with intestinal obstruction with overdosage you can get paralytic ileus. However I think it is an option to be kept available if the diarrhoea causes concern.

My plan would be to see him again in 3 months time and then if [Mrs 1] feels that it is appropriate we could consider performing endoscopy and further assessments neurologically and psychologically of his autism to explore the possible link between measles immunisation, bowel inflammation and autism.”

That was a plan to see the child again in three months time, but then if we go on to page 53, we see a letter written the same day to Dr Wakefield:

“I saw this interesting child with autism which began some weeks following MMR although there was 7-10 days after the MMR at the age of 1 a brief illness during which he was pale, possibly had fever and his mother said he may have been delirious. [Mrs 1] was keen that you would have a look at a document that she got concerning homeopathic remedies and I am passing this on to you.”

The next step was only one month rather than the three planned after the outpatients, the child was admitted, on 21 July, and if we look at the hospital records at page 9, we will see when that admission was. Those are the clinical notes for 21 July 1996:

“Referred for work-up of ? relationship between autism/measles/IBD. C/o classical autism diagnosed a year ago: diarrhoea and concerns over deterioration of eyesight.”

I will not go through all the notes because they are reproduced in the discharge letter that I am about to take you to where we see a description of apparent regression in the middle of the page:

“Till 1 year appeared very bright – had 5 words … walked at 14 months. Noted that he had lost words and was not progressing normally.”

The discharge summary is at page 49, where we see:

“[Child 1] was admitted for further investigation of his autism and specifically to look into a possible association between his neurological condition and any gastro-intestinal disorders. The main problems are ‘classical’ autism diagnosed 1 year ago, and of diarrhoea.”

Then it gives his birth history:

“[Child 1’s] developmental problems were first noted when he was 18 months. At this time his brother was being investigated for autism. Mum noted that until 1 year of age [he] appeared very bright and had apparently 5 full words. He also walked at 14 months of age. Subsequently he had apparently lost his vocabulary. According to mum he has not progressed normally since then, especially with speech and comprehension. There was no recall of his various social milestones.

As regards present development he has just started, once again, to say recognisable words …”

There is then information about his gastro-intestinal history, and going on to page 50, a third of the way down:

“He is up to date with his immunisations including his MMR … There is obvious parental concern that this has some bearing on his subsequent condition …

Both parents are well. He has a 5 year brother who has a speech problem and is also described as being part of the ‘autistic continuum’. He also has Toddler’s diarrhoea.”

Then we see the investigations: a colonoscopy was attempted; histological examination of the biopsies, a brain MRI, and we see at the bottom of the page:

“We would like to review [Child 1] in clinic to discuss the implication of the mild degree of inflammation seen in his biopsies. It is also not entirely clear whether his neurological condition in fact represents a neurological deterioration in view of lost milestones, or whether it is a classical autistic picture.”

Does that last sentence, Professor Rutter, which seems to encapsulate some of the matters that you were telling us about yesterday, cause you surprise that in fact this department did come to that conclusion that it was not entirely clear? In other words, is it an easy differentiation to make?
A It is relatively straightforward if you have experience in this area, so that the kind of picture presented would be the kind that you would see with many cases of autism.

Q Those were the investigations that took place, and in fact although the discharge does not mention it, we know also that in addition to the investigations that are set out there, including the MRI, there was an EEG. We can tell that from page 64, which gives the result:

“The patient was alert. Muscle and movement artefact troublesome.”

Then the findings from the EEG:

“The patient kept groaning intermittently during which the record shows sharpened waveforms … He resisted eye closure …”.

Then the conclusion:

“There are no EEG signs of major cerebral dysfunction.”

Prior to the discharge on that occasion there was a letter from Dr Casson to Dr Wakefield, which is at page 52. It is a letter to Dr Wakefield saying:

“Dear Andy

When would you like us to review this patient again and are there any other procedures we should be performing?”

Dr Casson told us in evidence that he would have written that letter on instructions by one of the consultants, and that he cannot recall how and to what degree Dr Wakefield was involved in the decision making. If this was a purely clinical admission would you expect to see a letter in those terms from a registrar to a researcher?
A No, because the researcher in this case did not have a contract that allowed him to be involved in clinical care; so if this was an issue in relation to clinical care that is not the person to whom one would turn

Q The next letter in the chronology is from Professor Walker-Smith to the general practitioner again, at page 48:

“Further to the discharge summary sent to you concerning [1], [Mrs 1] was unable to keep her Outpatient appointment …”

Then there are details in relation to the treatment for anti-inflammatories relating to the result of the colonoscopy and saying there should be some symptomatic benefit, and saying:

“I have not planned to see him again but Dr Wakefield will be assessing the research aspects of this problem and I would be happy to give further advice.”

Then arrangements were made for a second admission, and that is on page 47, direct from Dr Casson to Mrs 1 confirming the second admission and saying:

“He is due to have a barium meal and follow-through on Wednesday. He will have an EEG and evoked potentials at 11 am on Thursday. This will be performed under sedation. In association with this, whilst still sedated, he will need a lumbar puncture. During the admission various blood tests will also be taken. I hope this is satisfactory.”

Again I am sorry if this is rather an obvious question, but as far as the barium meal and follow-through are concerned, would there be any other reason other than a gastroenterological one for that investigation, that you know?
A Not that I am aware of.

Q By that time, Professor, there is a matter which you refer to in your report, and which I am going to ask you about in a moment, which is a report of an investigation, on page 114, which in my copy is very difficult to read indeed. Is yours?
A Mine is entirely illegible, I am afraid.

Q Mr Mellor is kindly handing us a very clear one. The point is it indicates an abnormal lead level, of 130 with a reference range of 100.
A Yes.

MS SMITH: I wonder whether my friends might be prepared to accept that for now, and we will have it photocopied.

MR MILLER: We have some better photocopies.

MS SMITH: I am delighted to hear that; that is splendid.
(To the witness) Professor Rutter, can I hand this copy to you, please. (Handed)
A Yes. I obviously did see a clearer one, because I make mention in my report, but the one here ---

MS SMITH: The Panel do not have clear copies; I am sorry about that.

THE CHAIRMAN: Can we just have a quick look at that and then pass it back to the Professor.
MS SMITH: Professor, would you hand it along to the Panel and then you can tell us what it indicates. (Handed to members of the Panel then to the witness)

(To the witness) You refer, as you say in your report, to the evidence of an abnormal lead level. Can you tell us, in a child with a behavioural disorder, and never mind just for the moment the precise nature of it, which we will be coming back to, why is that in your view relevant?
A It is relevant in two sorts of ways. Firstly, it is likely to have arisen through PICA, not necessarily but that would be the usual explanation. In other words, eating things like peeling paint, and so forth. The second thing is that lead is of course a neurotoxin, and therefore the question of whether treatment is required because of an additional effect of the lead in relation to the neuro-developmental, neuro-psychiatric disorder, becomes and issue. So when you get an abnormal finding like that you do have to follow through, both to see where did the lead come from, how did it get into the individual’s body, and is it at a level in which some sort of intervention is needed.

Q Could you find any evidence that that level was followed up?
A No. I looked for that and I could not find it, I am afraid.

Q If this child had been referred clinically for some sort of neuro-psychiatric evaluation or indeed for gastroenterological evaluation clinically, would you expect that result to have been followed up?
A Certainly. It raises warning signals and it would be essential to follow through.

Q On the second admission the child had, which as I have already referred to was on 23 October, the plan was an EEG and barium meal follow-through, but in fact he had previously on his first admission already had an EEG; but we see that other investigations were carried out. First of all he was seen by Dr Harvey, the neurologist, and his notes are on page 19. The history is noted, he says, and after a normal – I cannot read the next word – there is then a deterioration from 18 months or so, and he does some assessments of the central nervous system, does the tiptoes and the plantar reflexes, but he says “not a cooperative child, so nil else possible”.

It is pointed out to me that the word I cannot read is “milestone” – “after normal milestones a deterioration from 18 months or so”.

After that, page 91, he is consented for a lumbar puncture. We see the consent form for “lumbar puncture under sedation”.

Then on page 118 the CSF results, and we see that the sample was taken on 24 October, so that is the day after he was seen by Dr Harvey. In fact, if I can just refer back – I am sorry if this is a little confusing, but it is confusing in the records – the lumbar puncture had been planned although not carried out in the July admission, and if we look back at page 15 we see that plan to carry out the lumbar puncture during the July admission, and we see beside it “LP” and then a reference to the testing for, amongst other things, lactate, glucose, electrophoresis, and then measles antibodies.

So, as I say, the plan was made then, but he did not have it then, he had it when he came in in the October admission, and he had it the day after he saw Dr Harvey. Given that a neurologist saw this child prior to his having the lumbar puncture, what do you conclude about the appropriateness of the investigation in this particular case, Professor Rutter?
A I have tried to lean over backwards to avoid getting entangled in the adequacy of the clinical assessment, in that Dr Harvey is not, as it were, under investigation here. Therefore in my report I said that given that a neurologist had thought that this was required, it seemed to me one had to accept that. But I would have to say that it was based on the most perfunctory of assessments, not in keeping with any of the recommendations of any of the authorities that have been written on the matter. Its timing is wrong in relation to when things happened, so it is unsatisfactory in all sorts of ways. There is no argument put forward here as to why a lumbar puncture was needed in this particular child, so clinically most unsatisfactory. But given that ordinarily one accepts that if a patient is being dealt with clinically, then whatever one may think about the inadequacy of it, the clinician in charge has the right, as it were, to their own decision on that. Hence my report says, as it were – I did not say that I thought this was a very unsatisfactory way of doing things, but it clearly was. Nevertheless a neurologist, who would be someone who ought to know about the needs, had taken that decision.

Q Thank you. That is the neurological assessment. Were you able to find any indication of any kind of psychiatric assessment in this case?
A I do not think I did find that, no.

Q As far as that is concerned, we know in particular that this child had a brother who was also suspected of being autistic.
A Yes.

Q Would that have been a relevant matter to be taken into account psychiatrically?
A Certainly, but also neurologically as well. If you have a first degree relative who has, at least as reported, a similar problem, it would be mandatory to follow that through and determine on the basis of a proper assessment, does the child indeed also have autism or is that simply a misleading report. So, as with the lead finding, this is something that requires further study in whatever way seems appropriate. But as far as I could tell, that had not been done by anybody involved in the Royal Free assessment.

Q You said you would have expected that. Again, if this was a clinical admission would you expect that to be something that somebody would have been interested in?
A Certainly. I cannot imagine how you could not be, because it is so obviously potentially relevant.

Q You said in a number of respects that what was done at this referral was not what you would have expected of a clinical referral. Can I ask you, having gone through the records as we have, what is your overall view as to whether these doctors were in effect carrying out these investigations for research reasons or for clinical reasons?
A I think one has to conclude, or at least I felt that I had to conclude, that it was for research, in that there was a set protocol to be followed, and that there was not an assessment on the basis of the clinical circumstances of this individual child, what should be done. So it was a standard approach, and of course it was a standard approach that was being applied to a child who clearly did not have a disintegrative disorder in the ordinary sense of the word. So it was out of keeping as well with what had been proposed to the ethics committee.

Q You say he did not have a disintegrative disorder. Can you see anything in those records – we do not have a psychiatric assessment in the full sense – that relates to his behavioural condition which would justify his inclusion in a study of children with disintegrative disorder?
A No, I cannot find that. The amount of detail on this in the notes is quite limited, so one has to work on very limited evidence. But no, I could find no evidence for that.

Q If this were research, as you have expressed the view that you think it was, and if one of the inclusion criteria is disintegrative disorder, would you in fact expect to be able to find some sort of evidence not only of the condition but of how the conclusion had been reached that the child should be part of that research?
A Yes. The original protocol quite properly – this is the protocol that was sent to the ethics committee I am referring to – quite properly talked about a structured assessment of a disintegrative disorder. That was not followed at all, as far as I could see, neither in a standardised way nor in any other kind of way.

Q Lastly, two short matters, Professor Rutter. This was an admission in July 1996 and, as we know, the ethics committee gave approval from 18 December 1996. As a matter of fact, did this child qualify in relation to the start date?
A No, it was well before the start date that had been specified.

Q I asked you this yesterday, and at the risk of becoming tedious I am afraid I am going to have to ask you with every case because I want to ask you something at the end of all the cases. Were you able to find the research consent forms and the patient information sheets that were attached by the ethics application?
A No.

Q I am going to turn on to the next child, that was Child 3. Professor Rutter, it is page 14 of the your report. You will need the Royal Free records and the local hospital records for this child. If we turn to the referral letter first of all to Professor Walker Smith, that is in the Royal Free records. You can put the local hospital records to one side, you will not be needing them for a while. The Royal Free records at page 38. That is a letter from Dr Shantha, the GP, to Professor Walker Smith dated 19 February 1996:

“Dear Professor Walker Smith

Thanking you for asking to see this young boy who developed behavioural problems of autistic nature, severe constipation and learning difficulties after MMR vaccination. The batch incriminated was D1433, incidentally, which was the discontinued batch following adverse reactions.

He has seen Dr Oppenheim at Alder Hey Hospital and Dr Rosenbloom at the same hospital. He is attending a special school. His severe constipation is requiring frequent enemas and oral medication.

The parents are very convinced that the difficulties in behaviour etc started only after the vaccination.

I am extremely grateful for you to have taken on [Child 3] for case study.”

We have heard from Dr Shantha, the general practitioner, and I know you have seen the transcripts, but I do not expect you remember exactly what she said. She said she could not recall exactly but she must have received some information from someone asking for the letter that she sent. All I went to ask you is, the start of that letter thanking for a request that the child be seen, is that standard or unusual with regard to a referral letter from a GP to a consultant?
A Sorry, I misheard the beginning of that. Which aspect am I being asked about?

Q I am asking you about the first sentence:

“Thank you for asking to see this young boy.”

We heard from Dr Shantha that she cannot remember, but she said that she must have received information from someone asking for that letter. All I wanted to ask you was whether
A No, that would not be usual, it is the other way round.

Q The child was seen in outpatients and then Professor Walker Smith wrote back to the general practitioner. If you go on to the records to page 39, 4 April 1996:

“Many thanks for referring this child. As you say there is a clear history of the child being completely well until the age of 14 months when he had MMR. On the second day after the injection he developed a fever and rash and since then his mother noticed a dramatic change in his behaviour. He has also been investigated in the Alder Hey Hospital. Recently his mother was told by social services that it is likely the MMR might have caused the problem, had been in touch with organisations JABS who had mentioned the research that Dr Andy Wakefield has done at this hospital into the role of MMR vaccination and Crohn’s disease, hence my interest. We have now seen a number of children who have had features of both Crohn’s disease and autistic behaviour following MMR. Whether this is causally related I simply don’t know at present. Mrs 3 is keen that we pursue this avenue. In the first instance I have screened [Child 3] with routine blood tests etc and we will consider in due course whether it is appropriate to go ahead and perform a colonoscopy. A colonoscopy offers the opportunity to demonstrate if there is any ongoing infection in the gastrointestinal tract which could be in some way cause related to his problems.

Many thanks for referring this interesting child.”

That was his letter to the general practitioner. Later he wrote again at page 52 on 18 July 1996:

“Dear Dr Shantha

Initial screening tests for [Child 3] for inflammatory bowel disease were negative. However we are arranging for [Child 3] to be admitted on Sunday 8 September for colonoscopy followed by a period of investigation in the ward. We will let you know the results of those investigations in due course.”

On page 40, a letter of 4 April 1996:

“Dear Andy

There is a clear history of this child having been well until the age of 14 months and then the second day after the MMR injection there was a change in behaviour which has persisted thereafter and he has been diagnosed of having behavioural problems of autistic nature.

On examination he looks well and fit but clearly has disturbed behaviour. I have the routine bloods etc and I have told the mother that we would like to consider colonoscopy within the next one or two months and she has agreed. I have not yet booked for a colonoscopy until we have got the full details of the investigative protocol worked out.”

I am not asking you to comment on the clinical indications on whether this child should have had a colonoscopy, obviously. I will retain that for our gastroenterology expert. If it was being conducted for clinical reasons, would you expect its timing to be dependent upon an investigative protocol with a researcher?
A No, certainly not. One needs to move ahead when the clinical indication presents itself. The fact that research aspects have not been fully worked out would be neither here nor there. Inevitably in clinical practice you always have to work on the basis on knowledge as it is at the time. You cannot wait, as it were, for a further study to be done. That luxury is not available to you. It would be very unusual, to put it mildly, to wait for a research protocol to be worked out before you deal with the clinical condition that is supposed to be the reason for referral.

Q Going on with the story. Professor Walker Smith then wrote to Dr Rosenbloom at the Alder Hey Hospital. We have the letter at page 53. Dr Rosenbloom is the paediatric neurologist, is that correct?
A That is correct.

Q We referred to him yesterday because we referred to the paper he had written about disintegrative order and I asked you then whether he was known to have an interest in behavioural matters of that kind. I think you said he was.
A Very much so, he had a high reputation for that.

Q We see what Professor Walker Smith said:

“Dear Dr Rosenbloom

This child was referred to me by his GP because of my work of my colleague Dr Andy Wakefield at this hospital concerning the role of MMR in the genesis of Crohn’s disease and more recently possibly in relationship to the association with autistic behaviour. We have seen several children who have had both features of Crohn’s disease and autistic behaviour related to MMR vaccinations. I have therefore seen the child in the clinic. I would be most grateful if I could have a report of your diagnosis and previous investigations and particularly [your] views concerning his autistic behaviour.”

Dr Rosenbloom responded by sending the notes he had relating to the child. We can see his response letter in the local hospital records at page 182. He says:

“I enclose [Child 3’s] notes for what they are worth and would be grateful for their return in due course.

Like you I am interested in the link between MMR and all its sequelae. Do you have references available for the link between MMR, autistic behaviour and Crohn’s disease or even between MMR and autistic behaviour alone.

I shall be most interested to correlate what has been written with my own experience in this field.”

I am going to revert to Dr Rosenbloom’s views and the history that he gave in a moment. I would like to go on in the chronology for the time being. We see Professor Walker Smith’s response on page 180:

“Dear Dr Rosenbloom

Thank you so much for enclosing [Child 3’s] notes which I will let you have in due course. I am actually passing on your letter to my colleague Dr Andy Wakefield who is the inspiration of our work linking MMR, autistic behaviour and Crohn’s disease and I am asking him to write to you to fill you in on are proposed study.”

Then he says he is grateful for Dr Rosenbloom’s help.

Following on from that, there is another letter at page 178, again from Professor Walker Smith to Dr Rosenbloom, again thanking him for sending the notes but this time giving the plan:

“We are arranging his admission for Sunday the 8 September for colonoscopy, however the initial blood screens for bowel inflammation were negative, however Dr Wakefield is of the opinion that subtle changes in relation to inflammation may be present in such children and we have arranged [Child 3’s] admission for a week to 10 days for a period of intensive investigation. We will let you know the results in due course and return his hospital notes to you then.”

Again, I am not asking you to comment on the gastroenterology, but the information that is being given by Professor Walker Smith to Dr Rosenbloom, is that consistent with a clinical referral and a clinical investigation in your view?
A It would be unusual again, because it is referring to a hypothesis that Dr Wakefield had put forward about subtle changes in relation to information and so on. It does not actually deal here with the clinical problem as it presented.

Q We will revert to Dr Rosenbloom’s views, but if we can go on with the history at the Royal Free and go back to the Royal Free records at page 49. This is follows on from the letters to Dr Rosenbloom. We are now on 18 July 1996. It is to Dr Wakefield:

“Dear Andy

This child with autism has had no evidence of bowel inflammation on routine blood tests, however we are arranging his admission for colonoscopy on Sunday 8th September followed by your intensive investigations. I would be very grateful if you could arrange the other aspects of his admission.”

Later that same day, there is a letter from Professor Walker Smith to the general practitioner which is at page 52, slightly different terms, same information:

“Dear Dr Shantha

Initial screening tests for inflammatory bowel disease were negative. However we are arranging [him] for to be admitted on Sunday 8 September for colonoscopy followed by a period of investigation in the ward. We will let you know the results of these investigations in due course.”

Dr Casson, the registrar, writes to Mrs 3 at page 45:

“This letter is to confirm that [Child 3] is to be admitted on Sunday 8th September for colonoscopy. Any further investigations required will be decided on another occasion following consultation with Dr Wakefield.”

THE CHAIRMAN: What date is that?

MS SMITH: Sorry, 28 August 1996. We know that this child was then admitted on September 1996. Again, Professor Rutter, at the risk of being repetitious, that series of correspondence, is it suggestive to you of a clinical or a research admission and investigation?
A A research admission because of the reference to consultation with Dr Wakefield about the investigations to be done. If Dr Wakefield was not involved in clinical care, then the only reason for consulting with him would have to be on the research. That is not what one would ordinarily do.

Q If we turn to the discharge summary so that we can see the investigations that were in fact carried at, that is on page 26. We see:

“[Child 3] was admitted for investigation of possible inflammatory bowel disease and a possible association of this with his autism.”

His birth history is set out – normal pregnancy and delivery; normal developmental milestones until 18 months of age; subsequently he developed tendency to repeated activity. Sorry, I missed out a bit:

“Following this he lost language and developed markedly hyperactive behaviour. Subsequently he de eloped a tendency to repeated activity. He has problems with eye contact. Nevertheless he does have affectionate contact with other members of the family.

Had his MMR injection at 13 months and on the 2nd day after injection he had a fever and rash. Overall Mum considers his developmental regression has progressed since that time.”

He sets out his bowel symptoms which were, as the GP had said, constipation, occasional rectal bleeding although not accompanied by a passage of hard stools.

We see a colonoscopy was performed under sedation. The histology is set out; all the investigations from the blood tests including testing for measles; CSF results, so we know he had a lumbar puncture; barium meal and follow through which were normal; MRI scan of the brain which was normal with a small patch of altered signal; EEG within normal limits; impossible to perform evoked responses; and the observations:

“He does not appear to have significant bowel disease.

We will have to reconsider these findings when we review him again in clinic. As regards the protocol that patients who are being investigated as [Child 3] is concerned, we have been unable to perform the Schilling test and the evoked potentials.”

I ought to say also that in the paragraph above that I missed out:

“There are several mildly aberrant blood results specifically an elevated blood lead and an elevated lactate. No other metabolic abnormalities were detected. The significance of the MRI findings are uncertain.”

This is a case which you rightly point out in your report, Professor Rutter, in which the discharge summary was subsequently revised in relation to the histological findings, but that is a matter I am going to deal with our other expert.

Just as far as the neurological and psychiatric investigations at the Royal Free are concerned, if you look at page 15, we see the plan – the colonoscopy at the top of the page then:

“10 September Barium meal/follow through tomorrow
MRI on Thursday.”

On 11 September:

“Barium cancelled
? Friday.
MRI – LP, EEG and evoked potential investigations tomorrow.”

Going on down the page, we see 12 September:

“EEG today
Back from MRI scan
Has had EEG awake
MRI under sedation
LP under sedation
CSF clear sent ...”

and the various tests that were done – electrophoresis, lactate and glucose, measles antibodies, cytokine. Blood tests were taken and 10 mls used for measles studies, and again, at the bottom of the page:

“EEG under sedation.”

Is there anything in the clinical records that indicates in this child’s case that there was any part played by either a psychiatrist or a neurologist at the Royal Free?
A Not that I could find.

Q Before I ask you to express your views, I want to look at the previous behavioural assessments which had been done which are the background for you to those views. That starts with Professor Rosenbloom, and I have already taken you to some of the letters, the referral to Dr Rosenbloom. If we return to the local hospital records at page 200 we will see that that referral in fact came about through the psychiatrist to whom he had already been referred in Child and Adolescent Psychiatry at the Alder Hey Hospital. It simply said:

“After I saw you in clinic in Casualty, I went to discuss [Child 3’s] problems with one of my problems who takes a particular interest in children with some delay in their development. Dr Rosenbloom has said he would be most happy to see [Child 3] and will be sending you an appointment for his clinic.”

That is how it came about. The Alder Hey is the children’s hospital in Liverpool?
A It is indeed.

Q You tell us about the reputation of the hospital?
A It has a high reputation.

Q I am now going to have to ask you to look at the GP records. This is a letter written to the GP after the referral to Dr Rosenbloom, in fact by Dr Rosenbloom ‘s senior registrar. Page 121, it is dated December 1992 when the child was 2 years 11 months:

“Thank you for referring this little boy where I saw him on behalf of Dr Rosenbloom.

His mother’s main concerns are [Child 3’s] lack of speech.”

It gives the birth history:

“He walked at 13 months of age and used 2 3 words of speech until he was 18 months when this left him. He now has lots of unintelligible babble and appears to understand at one word level.”

It sets at various behavioural aspects:

“He spends most of his time biting the carpet or whatever happens to be in sight and flicking through books.

He enjoys some rough and tumble play with his Dad and hugs from his mother but otherwise is not interested in other children.”

She then describes how he was during the consultation time, very active, totally unaware of dangers. She summarises by saying that the child had already seen a speech therapist, or that the mother thought he had. She said:

“I am very concerned about this little boy’s development and he is really showing very little ability beyond the 12 month stage. I was also very concerned about his constant flicking through books and eating the carpet and very poor eye contact.”

There is then reference to the social circumstances and an indication that the child would be reviewed in the near future and:

“If his odd behavioural traits are still apparent I will refer him to the joint language clinic.”

He is then seen in outpatients by Dr Rosenbloom. If we turn to page 6 in the local hospital records, there is an outpatient’s appointment with Dr Rosenbloom. It starts on page 3. This is Dr Rosenbloom’s assessment setting out in detail the family’s history. If we turn to page 5 we see at the bottom of the page he says:

“Told parents of my concerns. They mentioned autism & I said I suspected that this was the problem.”

That was the part that I wanted to refer you to. Then if we look at the GP records at page 116, we see that followed through by the consultant community paediatrician at the Alder Hey, and he says that he reviewed the child in clinic:

“I had the opportunity to discuss [3’s] problems with [the social worker] … He was able to confirm my observations at the last visit that [3] continues to have very poor social skills, pre-occupations with eating the carpet and flicking through books and he is not flicking his fingers in front of his eyes. Mr and Mrs [3] are aware of [3]’s developmental delay and I expressed again to them my concerns about [his] poor social skills and that I considered that [he] may well fit into the category of childhood autism. They had already heard of this condition and did not look unduly surprised when I mentioned it. They have agreed to full assessment … in our specialist Joint Language Clinic.

I feel it is also important to admit [3] as a day case to carry out some investigations and his parents are agreeable to that.

I will then see [3] again to discuss the results of the tests.”

That was in March 1993.

Still in the GP records, page 115, we see the tests that were carried out by the Alder Hey. A letter this time from the specialist registrar to Dr Rosenbloom, 27 May 1993:

“I reviewed this young man with significant developmental delay, social difficulties and obsessional behaviours. His CT scan, EEG, amino acids, calcium and CPK were all normal. Unfortunately his chromosomes did not grow and therefore I am arranging for him to have the blood repeated when he comes to the Joint Language Clinic …”.

Then he remained under the care of the Alder Hey and we see a long letter from the parents to Dr Rosenbloom in relation to their concerns, which is in the local hospital records, please, if you go back to those. Page 183. This is August 1994 to Dr Rosenbloom, saying that from birth to the age of 13 months he had been a happy and healthy little boy, and then discussing how that had changed, and that when he had had his MMR – I am in the second paragraph –

“… we were told that he might have a slight temperature, which he did … Within 3 days of the injection [he] had started banging his head on his cot, rocking backwards and forwards on a chair or when sitting on the floor ... banging his nose against the wall causing him to have nosebleeds.”

It was attributed to behavioural problems because of the imminent birth of a sibling

Then at the bottom of the page, saying that his behaviour had got worse, they could not get through to him when they were talking to him, had to shout to get his attention; then setting out the history of how it continued to get worse. By the time he was 22 months old he had lost all speech – that is in the middle of the page.

Then at the bottom of the page:

“We first took him to the hospital (Alder Hey) in October ’92 where we saw Audrey Oppenheim” –

and that is the letter I have already taken you to.

“Then in May 1993 an educational psychologist … saw [him] at home …”.

An appointment to see a Dr White, then he was given an assessment at the Alder Hey’s Autistic and told that he was mentally delayed.

Now at the top of page 185:

“[He] has also had blood tests, brain scans and an EEG test which have all been normal …”.

Then at the bottom of the page:

“We both felt that the MMR needle has made [3] go the way he is today, and although it is said that the MMR has never been proven to make children autistic we believe that the injection has caused [3] to be mentally delayed which in turn may have triggered off the autism, and that is what we are fighting for. We are not against the Hospital, GP or health workers, all we want is to get justice from Wellcome the company who made the drug …” –

That is in relation to the side effects. Then we see:

“The legal aid board have refused us legal aid because they also say that there is no proof of the MMR needle to blame, but our argument is that it just” –

I cannot read the next bit, but it is clearly saying that the MMR was to blame. So that is an indication of the attempts at litigation at an early stage for this child, in August 1994. Dr Rosenbloom’s response to that letter is back in the GP records at page 110. It is to the GP, saying:

“I reviewed [his] progress …

I have told them that [3]’s acquired autistic problems in my opinion have occurred quite coincidentally to his MMR immunisation rather than that they have been caused by this procedure. I have however, now arranged for him to have an MR brain scan which will require general anaesthetic and will review [his] progress with the result of this investigation probably at the beginning of next year.”

He then says:

“The Vaccine Damage Payment Unit has asked for sight of [3]’s records and I have now forwarded these to that office.”

So that was his plan, to have the child undergo an MRI scan. On page 109 we see the results of that. The second paragraph:

“We have investigated [3] exhaustively including an MR brain scan which is normal.

I have told Mrs [3] that [he] does have brain problems but that time rather than further tests will determine how he progresses. She is very sad and is looking both for somebody or something to blame and also for specific treatments for [3] and I am afraid I have not been able to help her on either count.

Please therefore could she be supervised by the relevant local services.”

He says:

“I have not routinely arranged to review [his] progress but I will always do so if need be.”

That is the involvement of Dr Rosenbloom. Do you have any comments on it generally in relation to the investigations that he thought appropriate, Professor Rutter?
A As we have heard, he did follow through with investigations of a quite intensive kind, including an MRI using general anaesthetic. This is very much is area of expertise, he obviously had thought things through carefully, expressed doubt whether it was linked in the way that the parents had suggested, but nevertheless followed through in order to have better evidence available to deal with their concerns. That seems to me perfectly responsible, thoughtful, clinical care.

Q Yes. I have already established with you that there is nothing in the records at the Royal Free indicating any part played by a psychiatric or a neurologist, but I want to ask you this: is there any indication that you can find of investigations or assessments by the Royal Free which could have led to a diagnosis of disintegrative disorder in this child?
A Not really, no.

Q Given that lack of neurological assessment, do you have any comments as to the acceptability of the Royal Free carrying out a lumbar puncture on him?
A Yes. It seems to me that when somebody has been thoroughly assessed by an acknowledged expert in the field, that one needs to think carefully why you want to do it all again and add a further thing. So he had had an MRI with general anaesthetic already at Liverpool, so why do another MRI? Of course there are circumstances in which it is reasonable to repeat tests, so in itself that is not an issue, but giving children anaesthetics is not a neutral thing to be doing, and one needs to think carefully what are the indications in this particular child.

So far as the lumbar puncture is concerned, the fact that Dr Rosenbloom, who is very experienced in this field, had not thought it appropriate for that to be done makes one query why people at the Royal Free, who had far less expertise than Dr Rosenbloom had, nevertheless persisted. The issue of course is not whether they could not order a lumbar puncture; the issue is whether they are sufficiently experienced in this range of problems to know whether that was indicated.

Q Bearing in mind the background evidence that you gave us yesterday in relation to the appropriate clinical work-up for autism in your view, is it your view that in fact a lumbar puncture was clinically indicated in this case?
A No, I think it was not.

Q I have asked you this as we have gone along through the records, but overall on this case what is your view as to whether this was a research or a clinical investigation?
A I really fail to see how it could be a clinical case, because none of the ordinary criteria apply, so that I was forced to conclude that it had to be viewed as a research case.

Q Is there anything in your view which justifies the inclusion of this child in a research study of children with disintegrative disorder?
A No, because not only is the clinical picture as obtained not just at the Royal Free by the gastroenterologist but also at Alder Hey, this is not the diagnosis that they had made, nor does the clinical picture fit a disintegrative disorder. So in terms of that set of requirements, not in relation to what had been put forward, and in addition of course, at the Royal Free there was no kind of assessment of disintegrative disorder, standardised or non-standardised.

Q Then two last matters. This is an admission in September 1996, so did it in your view comply with the conditions set down by the ethics committee if it is a research programme?
A No, it is clearly outside that.

Q Again were you able to find any evidence of the research consent forms envisaged?
A No, I was not. Can I mention just one other feature which we passed over, and that is that we have the same problem with this child with the blood lead.

Q Thank you, yes. As you said it I remembered it; you are quite right.
A So the level of 140 is well over the laboratory norm of 100, and what is striking is that as far as I could see there were no investigations to determine where that lead had come from, how it had got into the child’s body, or whether it was responsible in terms of possible need for treatment.

Q Yes, thank you very much. Again, is that something you would have expected if this child was being clinically investigated, either neuro-psychiatrically or psychologically?
A Oh, yes, I would see that as routine. Any paediatrician should respond to a raised blood lead in this way. It does not necessarily mean that you would engage in radical treatment, but it does mean that you would have to find out where the lead had come from and come to a considered view as to whether treatment was needed now; and if not, then one would certainly be monitoring to see what was happening.

MS SMITH: Thank you very much, Professor Rutter. Sir, that is all I have on that child. May I respectfully suggest that it might be a good moment for a cup of coffee?

THE CHAIRMAN: Yes, it is very close to five to eleven. We will now adjourn and resume at a quarter past eleven.
(To the witness) Professor Rutter, my usual reminder again – and I hope you will forgive me for doing that, but I have to keep doing it, for the purposes of the transcript if nothing else. Please do not discuss about this case.

MS SMITH: Sir, may I just tell Professor Rutter, because he might find it helpful to know it, that the next two children that I propose to deal with are Child 4 and Child 6, just in case he wants to remind himself.

THE CHAIRMAN: I am sure he will find that information useful.

(The Panel adjourned for a short time)

THE CHAIRMAN: Ms Smith, just remind me what you are now going on to, please.

MS SMITH: Child 4, sir, and you will need both the GP and the Royal Free records.
(To the witness) This is at page 8 in your report, Professor Rutter. Just to remind you, this is I think the oldest child, nine and a half when he was referred to the Royal Free. If we could go to the GP records first of all, Professor Rutter, following it through chronologically, we begin at page 138, which is a request for information from the Vaccine Damage Unit, on 18 September 1995. So that is the first suggestion of concerns that vaccination might have caused the child’s problems.

Then if we go on, please, to page 125 we see the first letter in relation to the referral. This is a letter in fact from Dr Wakefield to the father of Child 4, dated 12 June 1996:

“Dear [Mr 4]

Thank you very much for your letter regarding your son. I would be very grateful if you could phone me or my secretary with your telephone number so that we can discuss this directly. It is much easier to answer many of the questions in this way. I look forward to hearing from you.”

Thereafter if we can go to the Royal Free hospital records, at page 27, this is a letter from the GP to Dr Wakefield, and the GP has told us that the mother made a request to him, and there was then a telephone conversation with Dr Wakefield, as we can see from this letter, and then this letter. The letter says:

“Dear Mr Wakefield

Following our recent telephone conversation I would be grateful if you could arrange an appropriate ECR appointment for [Child 4] to undergo assessment regarding his possible autism and his bowel problems.

[4] has had long standing difficulties and shows severe learning difficulties and … bowel disturbance and his mother has always found it difficult to accept that there was no known cause for [his] disorder. A few years ago she was chasing the idea that he might have a metabolic disorder and I enclose a copy of a letter I wrote to Dr Wraith in Manchester at that time although his reply was that he did not see any value in further tests along these lines. I’m aware that you are looking at the possible links between measles vaccine and various difficulties and [4] certainly had MMR in 1988. In general [4’s] mother thinks that he developed normally initially and then subsequently his problems worsened and he lost some of the milestones he had achieved but that he has subsequently improved on something of a restrictive exclusion diet. The professionals who have known [4] since birth do not entirely agree with this however and there is a suggestion that some of [4’s] problems may have started before vaccination.

Since 1994 [4] has continued to have intermittent problems with his bowels …” –

and he then sets out the circumstances of those.

“As I say [Mrs 4] is convinced that both [4’s] behaviour and his diarrhoea are triggered by his diet and she has him on something of a restrictive exclusion diet. He has not gained weight and we have been very concerned about this …

I would be grateful if you could arrange an appropriate appointment and would be very interested if you feel [4] fits into the sort of category of patient that you are interested in looking at further.”

Then in the GP records at page 123, Dr Tapsfield writes to Mrs 4:

“I’ve received further information from the Royal Free which suggest that [4] falls into a group of patients that they are interested in looking at further. I’ve sent them a letter down asking them to see him and I think they will be contacting you in due course …” –

And saying “If you have any worries, pop in”, so that they could take matters a little bit further between them.

The next letter is back in the Royal Free records, Dr Wakefield writing to Professor Walker-Smith, and it is at page 26, 4 July 1996:

“Dear John

Please can I pass on this referral which has come to me from Dr Tapsfield. [Child 4] sounds like a good candidate for our forthcoming study.”

I am using the phrase that you have used previously, Professor Rutter, but is that the language of clinical medicine or the language of research?
A The language of research.

Q Does the use of the word “study” in itself
A No, the word “study” can apply either to clinical investigation or research. It is fitting in with a set of criteria which makes it sound as if it is research rather than clinical care.

Q Then we get Dr Casson writing to the parents to arrange admission. That is in Royal Free records at page 25. It is in response to a letter I have asked you about before. It is dated 28 August 1996:

“Dear [Mr and Mrs 4]

This letter is to confirm that [Child 4] is to be admitted to Malcolm Ward at the Royal Free Hospital on Sunday 15 September 196 for colonoscopy. Any further investigations required will be decided on another occasion following consultation with Dr Wakefield.”

I ask you the same two questions relating to that. Leaving aside the gastroenterology aspects for Professor Booth to answer, generally speaking, if a GP makes a clinical referral to a consultant at a tertiary referral centre, are there any steps you would have expected prior to admission for investigations – between referral and admission?
A One would ordinarily get more details in order to decide whether that should be followed.

Q Normally speaking, how would the details be obtained?
A By a systematic assessment in outpatients.

Q As far as this letter is concerned, would you be expecting consultation with Dr Wakefield in relation to clinical investigations?
A No because it was outside the range of his contract, and that he was involved in the research side not the clinical care side, so that, ordinarily, that leads one to assume that the consultation is in relation to research but the investigations were said to be needed in relation to clinical care.

Q We know the child was admitted, and we can see the dates from the Royal Free Hospital records at page 3, where there is a printout, with an inpatient admission between 29 September. In fact, although the printout does not tell us, we know that he was discharged on 4 October 1996 and, we see again, under the care of Professor Walker Smith. If I can just look at page 5, so we can confirm the dates of admission, we see 29 September:

“Admitted for study of disintegrative disorder/colitis/MMR.”

The end of those notes are on page 13, which is the end of admission, which is 4 October. If we can then look at the discharge summary for the tests that were undertaken on page 21, to the GP dated 16 October 1996:

“Diagnoses: 1. Autism/developmental regression 2. Food related symptoms including...”

in particular gastrointestinal symptoms and lymphonodular hyperplasia of the terminal ileum.

“[He] was admitted to the Royal Free for further investigation of a possible link between a disintegrative disorder and colitis.”

It sets out his main problems. They include a behavioural disorder manifest by hyperactivity and developmental regression.

Turning over to page 22, it says that until he was 18 months of age, his development was normal at that time. At that time he began to lose words and developmental disintegration appears to have taken place from this.

“This does not specifically correlate with his measles immunisation.

He had his measles immunisation initially at 15 months of age and a 2nd subsequent measles immunisation at approximately 2½ years. Mum relates a change in his behaviour from a period extending 4 weeks after the 2nd measles immunisation. His play skills did not develop further. He became extremely hyperactive and indulged in destructive play.”

It then sets out the behavioural symptoms from which he was suffering. It says that he lost his eating skills, generally seemed to be more clumsy.

“Socially mum noticed that behaviour responded to dietary variation.”

Then he sets out the gastrointestinal symptoms.

The investigations were a colonoscopy; barium meal and follow through which they were unable to perform; MRI scan – no abnormality; lumbar puncture was not performed; EEG and evoked responses – nothing abnormal and evoked responses were within normal limits; blood results. It has been pointed out there was measles serology when the bloods were taken. Then we see at the bottom of the page an explanation of why the investigations were not all completed, the protocol investigations:

“Unfortunately because [Child 4] had a period of vomiting and being generally unwell scan it was impossible to complete all the investigations. We will therefore need to consider repeating these on a further occasion, ie barium meal and lumbar puncture.”

Just before I go through those, the lead results, does the comments you made previously apply in relation to these results?
A Yes, this was actually a higher level than either of the other two at 160.

Q Again, this is a bit tedious, would you have expected that to be followed up in a clinical investigation?
A Certainly, I would have thought, as was ordinary clinical paediatric practice, that would have to be regarded as essential.

Q If these children were being studied as a group, on the ones we have looked at so far in the order in which they were admitted to the Royal Free, would you have regarded it as at least something of note that there is a pattern about elevated blood lead results?
A Child 3 is striking.

Q As far as when these actual investigations were carried out, as I say we know he had the initial ones planned, he did not have the barium meal and the lumbar puncture because he was unwell. If we turn to the Royal Free records at page 67, we see the order of these investigations. Page 67 is the request dated 30 September 1996 for an EEG and evoked potentials. I will be corrected if I am wrong but there is a reference to barium at the top. I am not sure whether that is barium or not, but I think it says “barium not available”. The request is signed by Dr Wakefield and the reason for the request is given as disintegrative disorder. If these were clinical investigations, would you expect them to be requested by Dr Wakefield?
A No.

Q We are going into this in detail obviously when we conclude this patient, but was there any basis upon which Dr Wakefield would have been able to say that this child needed this investigation because he had disintegrative disorder?
A There is really not evidence of disintegrative disorder. The story is an interesting one in the sense of a later deterioration but it is clear it is against the background of the child having had developmental delay and gut problems long before the MMR. The account that the first immunisation was MMR is actually incorrect. The contemporaneous records indicate that was a monovalent measles and the MMR was only some years later. The clinical picture is not of a disintegrative disorder so it does not fit anything very much.

Q As I say, we will come to a bit more detail on that later, but whether or not the nature of his child’s behavioural order amounted to a disintegrative disorder, would you have expected that to be a reason that Dr Wakefield could have given at that point when ordering the investigations.
A No, not unless there had been systematic study by him which, as far as I can see, is not there in the records.

Q Thereafter, on 2 October, if we turn to the Royal Free Hospital records at page 11 we see that the child was seen by Dr Berelowitz. That is a note at the bottom of the page, 2 October:

“Seen for psychiatric assessment. Detailed report to follow.”

It is signed by Dr Berelowitz. He has told us he cannot recall whether he wrote that report or not, although he believes he did in relation to each of these children. There is no report that can be found in the records. Would you expect such a report to be in the child’s clinical records if one was produced?
A Yes, ordinarily if a systematic assessment has been made, it would routinely either have a detailed report in the records as such or a letter, as it were, summarising the findings. But, so far as I could tell from going through the records, neither was there. All that I could find was that very brief note.

Q In accordance with Dr Wakefield’s previous request, the child has the EEG on 3 October. That is at pages 64 and 66. If we look at 64, we see that it was done under sedation, the child having been sedated for the MRI. Nothing definitely abnormal was evident. There is then a further report, which I think is the evoked potentials report on page 66, also on the 3rd, but this time:

“The patient restless and tearful throughout the test.”

Nothing definitely abnormal was found to be evident. Then he had the MRI. We see the note of that on page 12 at the top of the page:

“MRI today, postpone lumbar puncture to a later date.”

Blood tests, also in accordance with the protocol, were taken. If we look at page 58 we see that some of that blood was used for measles virus antibodies. We have what was actually undertaken in respect of Child 4, at the Royal Free.

I now want to turn to the background of his developmental problems. That takes us back to the GP records at page 269 which is a letter from XXX Health Authority, the Children’s Department at XXX General Hospital on 19 May 1998. It says:

“I saw [Child 4] in clinic. As you know there were initially some worries about this child’s head and appearance. However, he seems to have done well.”

There was reference to his gastrointestinal symptoms and suggestions that he should have some dietary manipulation. In the last paragraph:

“I feel we should see him once more regarding his development.”

On page 263 in the GP records, a letter from the ENT surgeon. It is now apparent that the child seems to have lots of problems:

“At the age of two years and one month he apparently has a few single words only. He does not seem able to communicate his needs to his mother.”

An examination was done to see if it was related to hearing problems. The doctor said:

“Obviously I am more concerned about his increasingly apparent general delay. Mum was asking about this and although initially denying any problem, is obviously concealing quite deepseated worries about him being ‘backward’.”

In 1989 it was apparent that there were significant problems. Page 262, you refer to a letter setting those out in more detail:

“[Mrs 4] is becoming more concerned about his development and in particular about his failure to progress in language. She says that previously he had about six words but now says only ‘mum’. She comments that he seems to wonder about in is own world except when he is at home.”

He does enjoy playing with some things. He walked at the age of 18 months and is still unsteady on his feet and suggesting speech therapy assessment. There are continuing behavioural problems and you refer, in particular to a letter on 258, which is, again, ENT. It is now April 1989:

“[He] is still unable to follow the simplest of commands and does not appear to have made any progress whatsoever in the past two months in general terms. He has definite moments in clinic when he seemed less aware of what was going on than usual. All in all his general behaviour is increasingly abnormal.”

Then referring to his hearing problems and what was to be done about those. We have in 1992 a report from the consultant psychiatrist at page 217. This is from Dr O’Brien at the XXX Hospital saying that they had done an assessment.

“As I indicated before, the most important question is one concerning the prominence of his autistic symptomatology. At the risk of seeming pedantic, I would like to briefly consider the principle components of autism, and the extent to which they apply to [Child 4], separately and together.

First of all, there is the issue of age of onset. Usually, but not invariably, there is some sign of impaired development before the age of 3 years in autism. Now, in [Child 4] there is certainly evidence of some impaired development in these early years. We do seem to have evidence that at certain points in his development he has been more promising, but clearly at this early age he did show global signs of impaired development.”

He then sets out the cardinal features of autism:

“Abnormal functioning in social interaction, communication, and in respect of both restricted and repetitive behaviour.”

I am not going through all of these, but he analyses it by going through each of those heading and says:

“Unquestionably [his] social interaction is of the autistic type.”

On the next page:

“His communication is of course extremely limited and this has been apparent from the start.”

He goes into various linguistic anomalies.

“Thirdly, there is the domain of restricted repetitive behaviour.”

He goes into the nature of that. Then he says:

“It is clear, therefore, that [Child 4] has problems of the autistic type to such an extent that some people would indeed definitely make a diagnosis of autism. I refer here to the fact that there is divergence of opinion regarding autism’s status – some see it as a kind of ‘all or nothing phenomenon, others as a condition which does occur while having greater or lesser degrees or severity. It would be equally appropriate to use a phrase like ‘prominent autistic tendencies’ to describe his state. The overriding importance is that this is taken on board in his development and particularly his education.”

He says the various steps that should be taken for the management of the problem. Just pausing there, Professor Rutter, there is a diagnosis of some form of autism. Do you regard that as the kind of assessment that you would expect to see in terms of thoroughness at that stage by a psychiatrist?
A Yes, Dr O’Brien is experienced and it is a thoughtful sort of report dealing with the different features.

Q Thereafter there were various investigations taken in relation to this child there was a cytogenetic investigations, in particular in relation to Fragile X. This will become apparent in relation to some of the later children. Can I ask you what Fragile X is?
A It is a chromosomal anomaly which is normally picked up through DNA investigations and is associated with a variety of developmental problems, occasionally autism, so that the finding here of a Fragile X apparently on the earlier tests were certainly potentially relevant. As it turned out, it seemed likely not.

Q Absolutely. If we turn on to page 154 we see that those investigations were carried out and the conclusions in relation to them set out there. I will not go into the details of that letter, but it was from a consultant geneticist who was involved in the care. She says:

“There is no way that we can say that [Child 4] has Fragile X and it may turn out that there are many normal individuals in the population who have ...”

the particular genetic peculiarity, if that is the right word, that was investigated in him?
A Yes.

Q He had all those investigations prior to his admission to the Royal Free. Some months after his admission, the GP referred him to another psychiatrist, Dr Birnie, which is in the GP records page 99. This is a letter from the GP asking for Dr Birnie to see Child 4 urgently and saying that:

“He is a child with severe developmental delay and learning difficulties who acquired a diagnosis of autism from Dr O’Brien several years ago. More recently he has been showing increasing behavioural problems particularly around eating when fed by his mother. This has created something of a crisis in her management of him.”

If we turn to page 100, paragraph 6:

“Most recently [Child 4] has been referred to the Royal Free for the investigation of the possibility of the possible syndrome related to MMR vaccination. He had a variety of investigations although I do not have any very helpful summary conclusion of the letters. However, the general impression is that he does fit into the spectrum of children with autism, some GI symptoms and a degree of abnormality of the bowel on colonoscopy.”

Dr Birnie responds and confirms the diagnosis of autism at page 96. He says in the first paragraph:

“[Child 4] is markedly autistic and appears to have profound learning disabilities.”

He sets out the history and behavioural symptoms. On the last page of the letter at page 98:

“I will write to Dr Wakefield to see if I have any better luck of getting a summary of their investigations and conclusions. [Child 4] had a course (I think) sulphasazine after his investigations at the Royal Free. He became acutely distressed apparently with abdominal pain and his autism and behaviour did not improve. It was therefore discontinued after a fortnight.”

He said he would see Child 4 again later to follow that up. Are you aware of Dr Birnie, Professor Rutter?
A Only distantly.

Q You know of him?
A Yes.

Q As I say, that was the assessment which continued on autism. I want to just revert to the comments that you have made in your report. First of all, we know that in accordance with the protocol, investigations a barium meal and follow through and lumbar puncture were planned. They did not take place because the child was unwell. The discharge letter refers to that and to the need to readmit him. They were never undertaken so far as one can see. If those investigations, or investigations of whatever kind, are deemed to be necessary clinically, would you have expected further arrangements to be made for them to be undertaken on a later date?
A Yes, I certainly would. Ordinarily, if you think something is needed and it does not work out for practical reasons, you follow through. Of course, if in the meanwhile there is further information that comes in that makes you change your mind about the need, then ordinarily what you would do is write in the records and write to the referral doctor that, subsequent to finding whatever, “We have changed our mind about the need for this investigation”. I could not actually find anything of that kind in the records so, although personally these are not investigations I would have recommended, given that they were said to have been planned on the basis of clinical need, I would expect a follow through and I could not find that.

Q Can I ask you the same question in relation to the other children. Your overall view of these tests as they were carried out, again does it look to you like research or clinical investigations?
A It looks like research.

Q Could you find any indication of investigations at the Royal Free which could have led to disintegrative disorder?
A No.

Q Was there anything justifying inclusion of this child in a study of children with disintegrative disorder?
A No.

Q Even taking into account matters in his history, just how much was apparent to the Royal Free at that time of course one can only speculate. We know they had a history from the mother, but assuming that they also knew something of the assessments that had been made before, do they support a disintegrative disorder diagnosis?
A No, they do not. What they support is an autism spectrum disorder associated with really quite marked intellectual problems and bowel problems, that preceded the MMR, and there was a further change, as it were, apparently, after the MMR at a later age. But that did not take the form of a disintegrative disorder, and the early phenomena as reflected in all the reasonably detailed clinical records from elsewhere, that does not either. So it does not fit the criteria.

Q On the two points I am asking you in respect of each of them, again the admission date for this child was September 1996, so did he qualify in respect of the start date for the study?
A No, he is specifically outside the exclusion criteria laid down by the ethics committee, i.e. that only after approval had been given would it be allowed.

Q Did you find any sign of the consent forms and patient information sheets envisaged?
A I think I did not, no.

Q Just reverting for a moment, Professor Rutter, to the point that this child was apparently admitted for investigations without being seen in out-patients – you have already told us you would have expected an assessment in out-patients – is that relevant to the overall view you have expressed that this was research rather than clinical investigation?
A It would be one of the elements that led up to that view, yes, but it is really the combination of the various different elements that all point in the same direction rather than any one, as it were, being decisive.

Q Thank you; that is all I have to ask you about Child 4, and I will now turn on to Child 6, which is, for reasons I will explain, a brief one. The records are either in GP records or they are going to be in the file which is marked ‘Additional records for Child 6’. It is page 21 in your report, Professor Rutter. Just so we are all clear about this case – because, as I say, there is a limited amount I need to ask you about it – I think at the time you originally wrote your report you only had the general practice records, you did not have the Royal Free records?
A That is correct.

Q Since then you have had a chance to see those, but they came from an indirect source, through the defence, and we are unsure if they are complete. So there is a warning note with respect to the Panel with regard to those records.

We do have the referral notes in the GP records, and could I ask you to go to page 125 in those, please.

MR COONAN: Just before that is done, there was a possible pregnant implication by Ms Smith.

MS SMITH: No, no.

MR COONAN: What has been handed over by the defence is complete in terms of that which the defence had available to it. That was the possible implication which might appear on the face of the transcript, so I think it is worthwhile clarifying that point. It may be that the notes taken as a whole are not complete, but that is a different point.

THE CHAIRMAN: Thank you.

MS SMITH: It was not remotely meant to be pregnant, it was just meant to be factual, so we understood ---

MR COONAN: I am not suggesting it could, but it could have been construed in that way in the transcript – since we are looking at documents.

MS SMITH: (To the witness) Page 125, please, of the GP records. This is a letter from the GP to Dr Wakefield dated 9 August 1996:

“Following our discussion over the ‘phone the other day [6] is a little boy with autism syndrome who does also suffer from bowel disorder. His mother is interested in entering him into your trial and I would be grateful if you could see her for discussion.”

Then if you look in your additional records file, please, at page 2, we see a letter from Dr Wakefield to Professor Walker-Smith:

“Dear John

I received this letter from a GP who has a child with autism and bowel disorder who may be suitable for our study and who, I am sure, would be appropriate to be seen by you in Outpatients.”

Professor Walker-Smith did indeed see this little boy in out-patients, and then wrote to the GP. Again in the additional records at page 6 we see the letter he wrote. This is dated 4 October 1996:

“Many thanks for referring this boy, he certainly fits into the spectrum of a child diagnosed as autistic who also has bowel symptoms, as there is a history of recurrent abdominal pain …” –

and he sets out the bowel symptoms.

“I am arranging for him to come in to have a colonoscopy and entering our programme of investigation of children with autistic problems. He will be admitted on Sunday 27th October … In the meantime I have arranged for him to have simple screening for inflammatory markers. I will let you know the results in due course.”

With regard to that letter, again, Professor Rutter, what does that suggest to you in terms of clinical or research investigations?
A In that it is presenting the issues in terms of the set of features that are relevant for the study, it sounds more like research, although it is a letter that could be read either way, I suppose.

Q I should have taken you to the interceding letter, which is at page 3, which is Professor Walker-Smith’s explanation to the GP of why he has become involved:

“I have been asked by Dr Wakefield to see [6] as I am the Paediatric Gastroenterologist associated with Dr Wakefield in our study on autism and bowel disorder. I have taken the liberty therefore of sending … an appointment … I would be grateful if you could explain the situation to them.”

I am sorry, I should done that. That is the chronology of it.

The same day as the letter was sent by Professor Walker-Smith to the GP we see Professor Walker-Smith to Dr Wakefield, at page 1 in the additional records file. This is dated 4 October – it says 1995, but it is pretty clear from the context of the letter that it is a typographical error.

“Dear Andy

I was very interested to see [6] in the clinic. This is a child who has been diagnosed as Asperger's … In relationship to the MMR, he apparently had a measles rash a week before MMR at the age of 15 months, but the doctor proceeded with the MMR injection. He had behaviour changes within a week although [his] mother has only relatively recently associated the change of behaviour with the MMR. She also believes that he had a blotchy rash a week or so after MMR which lasted 2 days and she thinks was accompanied by a fever and a cold. He subsequently was diagnosed as Asperger's syndrome by Dr Bennett. Mother is rather vague about precise details, …” –

and it then goes into the gastrointestinal history.

“She says she has seen several doctors about this. On examination his nutrition is good but he is clearly quite a disturbed boy. He fits well into the spectrum of children we need to investigate. I have arranged for him to be admitted on Sunday 27th October 1996.”

He was indeed admitted to the Royal Free, and we can see in the additional records at page 41 the dates of that admission, from 27 October to 1 November, under Professor Walker-Smith. For the investigations that he underwent we have a brief list in the GP records at page 121. This is not a full discharge letter but a brief discharge notification, and we see under “Procedures undertaken” that he had a colonoscopy, MRI, lumbar puncture, evoked potential tests and an EEG. I am sorry to keep taking you from file to file, but we know from the additional records file at page 158 that he had bloods taken, and that they were tested, as we can see there, for the measles virus, and indeed mumps virus, so there was virology testing to the blood samples.

We also know, Professor Rutter, that sometime during his admission he saw Dr Harvey, the neurologist, and we know that because in the GP records at page 245, which is a much later – 2001 – referral to Dr Harvey, Dr Harvey said in his letter to the GP:

“Many thanks for your kind referral of this young man, … I have actually met [him] before, when I was on the staff of the Royal Free Hospital and I examined him neurologically at the request of my colleague Dr Andrew Wakefield, who was investigating XXX with autism and the relationship with chronic inflammatory bowel disease.”

As I say, we do not know when he saw Dr Harvey during his admission at the Royal Free, but I think in those circumstances you are not in a position to express an expert opinion as to whether a lumbar puncture should have been performed?
A That is correct, no, I cannot, because there is no information there.

Q But in fact, just as a matter of record, because it may be relevant to the overall issue that I have already asked you about, as to whether this investigation should be undertaken lightly, he did suffer consequences from his lumbar puncture. If we go to the GP records at page 32 we can see that. At the top of the page we see:

“Lumbar puncture last Thursday.
Vomited on the way home.
Now complaining of headache & pain in his chest …”.

There was general advice following a telephone call to the Royal Free, and in fact – I will not take you to the record – it involved a short visit to the hospital for observation. As I say, you are not in a position to criticise the lumbar puncture being undertaken, but is this some indication of what you said to us yesterday, which is that it is a relatively safe and routine procedure in good hands, but nonetheless it is not to be taken lightly.
A Exactly.

MS SMITH: We also now know, even more recently and from another source, that this little boy did in fact see Dr Berelowitz. I just want to hand in for completeness, sir, in the records that we do have, the report that Dr Berelowitz did on Child 6. it is on yellow paper, and the reason for that is that it was produced during the course of this trial by Professor Murch’s representatives. I am trying to say this in a non-pregnant way. I am not suggesting there was anything curious about it, except that plainly it came to light. As I say, it is on yellow paper so you know the source from which it came. (Handed)

THE CHAIRMAN: Which file is it going into?

MS SMITH: I am afraid it has to go into the FTP file, FTP2, at page 605e. You will see the reason why it is being inserted there – there is very considerable method in what might seem like madness – is because at 605d there is a letter from Dr Wakefield to the mother of this child, and indeed the other child, setting out the diagnoses which were obtained from Dr Berelowitz, so we are just slipping behind there, and in a moment we will be getting the one for Child 7.

(To the witness) Just so we know what this says, Professor Rutter, first of all it is a letter dated 3 June 1997, so it is some months after the actual admission to the Royal Free in April 1996; and it appears that the child was seen after the Royal Free admission. He says:

“Dear Andy

Thank you for referring [child 6] to me. I saw him on the 11th November 1996 but I see from my records that I did not write to you about him.”

Then he sets out the history, and the mother’s account.

“His mother was a little unclear about his developmental history, but said that he sat late because of obesity. He walked at 13 months. She was not sure when he began to speak, but said he had perfect speech, though it was a little stilted.

In terms of his present state, she said there was little imaginative play …” –

and she goes into the various imaginative play he was able to indulge in.

“He had accurate memories of all he saw on TV and liked to talk in an adult voice. He would not go to his parents for comfort and reassurance. He was far more likely, in fact, to try and tell off the object that upset him. He has little interesting conversation and he is hard to empathize with. He laughs when he hurts his brother. His understanding of emotions is slightly off. He has an accurate memory. He prefers the company of adults to children. He is obsessional with his food and with play. His behaviour is worse when he has diarrhoea; on those occasions he seems drunk. He is not trying to read yet and has some problems with writing.

Because of the mother’s uncertainty about the timing of his developmental history, it is a little hard for me to be as confident as I would like about the diagnosis. However, it would seem that the most likely diagnosis is Asperger's Syndrome.”

So that was the conclusion apparently that Dr Berelowitz reached in relation to this child, and the only other information we had. The only limited questions I have for you, Professor Rutter, are firstly, we see that the tests that he underwent were a colonoscopy, MRI, LP, EEG, evoked potentials and blood tests. Do those seem to you to be consistent with the protocol of investigation that was covered in respect of the other children?
A In that those are the same ones, yes.

Q Are you able to express any opinion at all as to whether this child qualified for a study into disintegrative disorder on the basis of the information we have?
A On the information now from Dr Berelowitz I would have thought not. He quite rightly expresses where there is good evidence and where there is not, but a diagnosis of Asperger's syndrome is quite a long way away from disintegrative disorder.

Q Within the spectrum of autism spectrum disorders, where does Asperger's come?
A It is at the milder end.

Q We know the admission was in October 1996, so do the observations that you have made already as to the start date of the protocol apply?
A Yes, indeed, it is before approval was given?

Q I am sorry?
A It is before approval was given.

MS SMITH: Thank you very much; that is all I have to ask you about Patient 6. Would you excuse me for a moment.

The next child I want to look at is Child 9, and that is page 25 in your report. As far as the Panel is concerned, they will need the GP records and the Royal Free records for Child 9.

Just to identify, this is the child who comes from XXX, and the referral to the Royal Free begins with a letter in the GP records at page 91. It is a letter dated 11 September 1996 from Professor Walker-Smith to Dr Spratt, who we know is a consultant paediatrician.

“Dear Clifford

“We recently have become aware of a syndrome of enteritis and disintegrative disorder or autism. We have in fact investigated two children so far and during treatment they both had evidence of bowel inflammation. Whether this relates to Crohn’s disease or whether it is related to measles immunisation or measles itself is quite unclear. However, I have heard from Dr Wakefield that there is a child called [9] who is resident in XXX whose parents would be quite keen for us to investigate the child in our protocol. I am just wondering whether you think that this is at all appropriate. If you felt it appropriate I would be happy to see the child.

Just in case you may be interested, I am enclosing a copy of Dr Wakefield’s detailed proposal. I look forward to hearing your comments.”

Attached to that letter, Professor Rutter, was a document which is familiar to you, starting on the next page, page 92, which is the proposed clinical and scientific study that was attached to the Ethics Committee application.
I want to ask you, firstly, do you have any comments about the way that that referral came about? In other words, how would you describe that as a clinical referral? Is that the normal way you would expect it to come about?
A No, it is a bit unclear exactly how there was an awareness about this child but, as it were, the letter indicates that it was a prompted referral and, moreover, it was a prompted referral in relation to a specific study. A protocol was enclosed with the letter making it clear what was involved.

Q Yes.
A So it certainly reads I am sorry, it certainly reads as if this is in relation to a research study, not an ordinary clinical referral.

Q We see Dr Spratt’s response to it which is at page 38 in the Royal Free records.

“Thank you for your kind letter of 11 September ..”

he writes, and this is on 25 September 1996.

“I would of course be very pleased to have your opinion of [9’s] distressing case history, and to take your advice about his proposed referral to Dr Wakefield’s service.

If convenient, could I suggest you send his parents notice of a clinic appointment or short-stay admission to your ward - as you prefer - directly.”
Now, given that this is a referral to a gastroenterology unit, albeit using the word that you have used, a prompted one, does anything strike you as being curious in its absence?
A Well, there is no mention of gastrointestinal problems in the referral letter.

Q There was an outpatient appointment and, again, I will ask Professor Booth to deal with the gastroenterological issues that arise, but if I can refer you to Professor Walker-Smith's letter, which is at page 36, dated 8 November 1996:

“I duly saw [9] in outpatients. From a gastrointestinal point of view it is interesting that he does pass one loose stool a day which in fact seems to be his pattern from the age of 2. He also has screaming attacks which are clearly related to food which his parents attribute to abdominal pain, it is difficult to interpret this.”

Then there are references to his diet.

“We have now seen several children with autism and gastrointestinal symptoms, all of whom on gastrointestinal investigation have proved to some kind of bowel inflammation. It is quite difficult to relate this directly to autism, Dr Wakefield as you know, believes that immunisation may play some part, although I remain neutral on this issue for the moment. However the parents are keen that we should endeavour to investigate [9], and I have therefore arranged for him to come in to have a colonoscopy. He will be admitted on the 17 November we will then endeavour to follow this by barium meal and follow through and also to do a repeat lumbar puncture. We will let you know the results of these investigations.”

So there is a reference by Professor Walker-Smith to the fact that the lumbar puncture would be a repeat. Can I ask you, would you expect in a clinical referral of this kind to see a plan to do a repeat lumbar puncture prior apparently to anything other than an outpatient gastrological assessment?
A No, that would be unusual and ordinarily one would certainly want to track down what the previous lumbar puncture had shown and under what circumstances that had been obtained. I was unable to find that in the records.

Q Yes. Now, in fact, what we can find is that there was one previously and that I am sorry, sir, it is in another set of records, the Chelsea and Westminster Hospital records, for child 9. If we go to page 36, that is the consent form for a lumbar puncture to be undertaken under general anaesthetic, and it is signed 18 May 1995. We know he had the lumbar puncture that day, if we look at page 76. These are the nursing notes but they make the plan clear from the top entry:

“Lumbar puncture under sedation attempted but unsuccessful. To go to theatre tomorrow morning for lumbar puncture under general anaesthetic.”

Then we see steps that are taken in relation to anaesthesia. We know that that lumbar puncture I am having pointed out to me on page I am sorry, it is my page 76 and for some obscure reason it is my junior’s page 75. Whatever the page number, it does indeed say just down from the middle:

“Had lumbar puncture under general anaesthetic. Sleep for few hours pm.”

Are you with me?
A Yes, I am, indeed.

Q It simply shows that he did indeed have a lumbar puncture at the Chelsea and Westminster.
A Yes. What I meant when saying I could not find it was that I could not find it in the Royal Free notes.

Q Exactly. I understand that and, indeed, there is no evidence that we can find of them having made the inquiry but we know that it took place and so presumably the doctor must have been told by the mother. It was in the context in fact of about 12 investigations and if you look at page 17, still in the Chelsea and Westminster records, at the top of the page we see the words “Consultant: Bhatt Cav”. Dr Bhatt is a doctor with a specialist interest in B12 and Dr Cavanagh, we know it is my page 17. There is obviously something wrong with either my or everybody else's numbering. Professor, do you have --
A Mine is 17 too.

Q So you and I are in accord. Do the Panel have page 17? In that case, everyone but Mr Miller has page 17. As long as the Panel have got it, perhaps everyone will agree that I will make sure that they have copies afterwards. I am sure my friends will take it from me that at the top of the page it says “Consultant: Bhatt Cav” and Dr Bhatt is a specialist, as we know, in B12 investigations, Professor Rutter, and the “Cav”, C-A-V, is a shortening for Dr Nicholas Cavanagh. I think it is right that he is the paediatric neurologist at the Chelsea and Westminster.
A Yes.

Q So it appears that there was a paediatric neurologist involved in that investigation and the note says that he was to be readmitted for B12 investigations and so that was the context of his previous lumbar puncture. Now, if we can revert, please, with some relief, to the Royal Free records, page 36, which is the letter that I have already asked you about, we will go to the history behaviourally in a minute but, on the basis of that letter that Professor Walker-Smith knew by whatever course and was correct in his knowledge
A Yes.

Q that this child apparently had a diagnosis of autism and in fact had had a lumbar puncture 18 months previously, is there any clinical reason for a planned admission for, amongst other things, a lumbar puncture that you can see?
A Not in terms of the records that I have been able to see.

Q In fact, child 9 was admitted to the Royal Free on two occasions. We can see the dates of those on page 4 of the Royal Free records. At the bottom of the page, under patient episode summary, inpatient admission from 17 November to 22 November 1996 under Professor Walker Smith and from 9 December to 11 December 1996, again, under Professor Walker-Smith. If I may, I am going to look at the investigations he underwent. I am going to go through them before I go to the discharge letter because the discharge letter was composite to both admissions. We know that on 18 November he had a colonoscopy, and that is in the Royal Free Hospital records at page 9, which shows that he was admitted on the 18th and we see, at the top, complaining of autism and query Crohn’s disease, and there was a behavioural history set out, that he smiled at five to six weeks, down in the middle of the page, sat up without support at 29 weeks, but then around 18 to 20 months regressed progressively with his speech, MMR at 16 months, walking on his own at a year, and then setting out the gastrointestinal history. If we go to page 73, that indicates that he did indeed have a colonoscopy, because that is a report from it, and is dated 18 November, so that is the day after admission. Then the records at page 11 show that he had a barium meal and follow through, we see, in the middle of the page. Then, as we have already seen, he was discharged on 22 November but we can also see from page 11 that there was a plan, and I am looking at the 21 November ward round, in this case, Dr Murch:

“MRI and LP to be done under GA at a later date as [9] likely to be distressed with a local.”

He is readmitted on 9 December and if we turn over to the next page, page 12, you will see that re-admission for MRI, LP, and bloods with the MRI and the LP to be under general anaesthetic and there is simply a note saying that he is otherwise well and then a arrow, “autism”.

There is a consent form for those procedures on page 44, MRI and LP under general anaesthetic. The CSF results are at page 53 and we see there CSF and the results. It would appear that in addition to those he also had an EEG on 10 September, and we can see that from page 86. We see the EEG was also performed under general anaesthetic and did not appear to show any significant abnormalities in so far as they were able to tell, but assessing the background or ongoing EEG was impossible due to the anaesthetic cocktail that the child had been given. So those are the investigations that he had and, albeit he had them spread over the two admissions, apparently because the lumbar puncture had to be performed under general anaesthetic, do they again accord with the investigations which were planned investigations in the study protocol?
A Yes, indeed.

Q Subsequently, Professor Walker-Smith wrote to Dr Spratt on page 33 of the Royal Free records on 31 December 1996.

“Dear Clifford,

[Child 9] was duly admitted ..”

and then the results of the endoscopy and histology.

“Other investigations were however normal and are being collected and you will have a discharge summary soon.”

Diagnosis, and a therapeutic trial of anti-inflammatories. He says:

“We have now studied seven children all of whom have some evidence of enterocolitis and disintegration disorder following MMR. Two of these may have Crohn’s disease. One of these has improved significantly on enteral feeding.

Clearly this is difficult group of children and our work is only beginning but we will keep you informed.

I wonder if you have seen any other similar cases in XXX.”

Thereafter, there is a full discharge summary sent which, as I say, is composite to both admissions, and that is at page 31. This is dated 14 January 1997.

“Diagnosis: Autistic Spectrum
Indeterminate Colitis, Lymphoid Nodular Hyperplasia.

[9] was admitted to [the] ward on 17/11/96 for investigation of his autistic behaviour of gastrointestinal symptoms.”

Then it says that he started off apparently normally.

“At 18-20 months of age he started to regress mentally. His mother links for that with MMR which was given at 16 months of age. He started having loose stools around the age of 2-3 years ..”

Then there are various gastrointestinal symptoms. His motor development was appropriate for age.

“When he was with us he also underwent neurodevelopment assessment, the results of which will be forwarded to you.”

Then the colonoscopy and the results of that and the other investigations that he had.

“All his investigations were normal except for a very high lead level which was 266 I.U. The normal range of 100.”

Dr Malik, who was the registrar, says:

“I’ll be obliged if you can repeat this. As part of the investigation protocol he also had an MRI of his brain which was normal.”

Then they set out the gastroenterological conclusions and said there was no arrangement for a follow-up. Now, as far as the lead level is concerned, is this exceptionally high from what you have said about the previous ones?
A It certainly is.

Q Yes. There is a request that it be repeated by the local paediatrician in this case. We do know that it was subsequently followed up, including a referral to a specialist in that area, by the local paediatrician. Again, would you have expected the Royal Free Hospital to be interested in that elevated lead level?
A Yes. I think it was reasonable that there was coordination with local services for that to be done but obviously, in terms of the clinical assessment at the Royal Free, yes, it had to be part of what they were interested in. The question as to whether the further investigations were done at the Royal Free or in XXX is a separate issue and, in this particular case, it was followed through in a perfectly appropriate manner in XXX really in line with the point I was making in relation to another child earlier, that is to say, there was the investigation as to where this had come from, and in this case it was lead in the paint, and that the investigation then looked at other members of the family and found that it was only in this child. Presumably, he was the only one eating the paint. So that is the sort of thorough approach that one would expect and I would regard it as perfectly appropriate that that be done locally if that was the agreement between the Royal Free and Dr Spratt.

Q Yes, thank you. I am not going to take you to all the letters in relation to that. It is fair to say that Professor Walker-Smith was kept informed of the investigations that were being undertaken in this case.
A Yes.

Q You said it certainly was high. I mean, it was very significantly higher than the previous ones we have looked at which were also elevated.
A Yes.

Q A request that it be repeated, might that have been a reflection of the fact that it was so very high?
A Yes. One always is concerned with one very unusual finding to check that there was not some methodological error that took place. Those are not common but they can occur even in the best run services. So it would have been appropriate to repeat it and check whether you have still got a high level and I understand from what is said that it was still high.

Q Yes. But that local follow-up, you have criticised the lack of follow-up in relation to the previous children that we have looked at.
A Yes.

Q Would you expect either that sort of arrangement to have been made in respect of them or for the Royal Free themselves to have
A One or other of those, yes.

Q Now, turning to the behavioural history pre the referral to the Royal Free Hospital, there were considerable concerns about delay in relation to this little boy from an early age and he was referred for an assessment at the Autism Service at Southampton in November 1993. That is in the GP records at page 143. This, as I say, is November 1993, 4 November, and the letter is from consultant paediatrician Dr Rolles. It says:

“Clifford Spratt has asked us to see [the child] for assessment in our autism service.

[9] is now three and a half and his parents say they would like ‘clarification’ of his condition. They feel that he has already been labelled as having some degree of autism but they want to know more about the type and the severity.”

Then, at the bottom of the page:

“During his first year his parents felt there was nothing untoward even in hindsight. They say that his development was normal and healthy and neither they nor anyone else felt there were any problems at all. He was walking before his twelve month mark and he also had one or two words such as ‘mumma’ and ‘dadda’ around the age of one.

During the second year of life he tended to be fairly well without anything untoward at that stage that was noted by anybody.”

Then there is some suggestion that, with hindsight, he had ceased a particular type of play at 16 to 18 months.

“During his second year he had an assessment from the health visitor and he was found to have no speech. The parents were obviously very worried about this but they claimed that the health visitor and general practitioner said that he was probably okay ..”

Then there were concerns in relation to his hearing.

“When he had reached the age of almost three, he was seen by an educational psychologist who thought he had a number of autistic characteristics.”

Then he sets those out, and I will not go through them all. He asks about various particular categories relating those autistic symptoms. Then he says at the end, on page 146:

“My own impression, just in this first visit, and with the information sent to me from XXX is that this child certainly has a number of autistic characteristics.”

Although he thought at first it was a severe problem with no communication, as the interview progressed the outlook was a bit better. He said:

“I pointed out that with autism there are dangers of making a very firm diagnosis early because children change and from the history it is clear that this child is at the stage where he is presently making progress. I felt that there was no harm in the fact that our assessment service does have a waiting time because with the rapid change the boy is making at the moment, a further few months delay may show further continuing change and make assessment more reliable. The family were very happy with my plan to have this child come over for full formal assessment which I said might not be until the early spring.”

So, again, Professor Rutter, is that in your view as far as you can tell obviously just from the documentation, a full and careful assessment of this child's condition?
A Yes, it was.

Q Apparently, in what is called an autism service, that is a known department in a hospital, is it, a service that particularly assesses a child's
A In some centres, it is. Because of the particular features of autism there has been the development in several centres of a service that particularly is concerned with children who either have this disorder or thought might have this disorder. So it is a building up of expertise so that it would often be not just a tertiary referral but in relation to a more general service there would be a sub section dealing with this, and there is so in Southampton.

Q We have already seen, and I will not go back to it, that prior to the referral to the Royal Free Hospital he had indeed seen Dr Cavanagh, the paediatric neurologist, who had admitted him for investigations.
A Yes.

Q Can I ask you the overall question first? With regard to the programme of tests that were performed on this child, what is your overall view as to whether it was a clinical or a research admission?
A The overall pattern is much more consistent with it being a research case.

Q Can you tell us what specific aspects of that make you conclude that?
A As with others, it is several features. The manner of referral, we have talked about. The lack of taking account of what has been done elsewhere, where there are quite thorough assessments, but those do not seem to have played a part in the decision-making at the Royal Free, that there was a standard set of investigations, one of which involved an investigation that had been done before which could be clinically justified but only if one looked into what had been done at the previous time, and although records were available, as far as I could see, they had not been checked through by the Royal Free, and that the indication in terms of the feedback to Dr Spratt, the letter initially dealt with I am afraid I have lost the place now but it dealt only with the gastroenterology and did not mention the raised lead levels. The subsequent one did but what did not happen was a consideration as to whether that had any implications, as it were, to the overall clinical picture. So I am perfectly happy about that having been handled locally and, indeed, it would have been much easier to do so locally, so that made good sense. What I was slightly puzzled by is that, that having been done, it was not clear that note was taken in terms of anything else.

Q Yes. Now, turning to the lumbar puncture, there is no indication of any kind of neurodevelopmental assessment at the Royal Free, no evidence that this child was seen by either a neurologist or a psychiatrist. First of all, can you see anything justifying inclusion of this child in a study of children with disintegrative disorder?
A No, because on the evidence available that is not the kind of pattern that is shown by him.

Q Do you think that the lumbar puncture which was undertaken was an acceptable decision, given the lack of a psychiatric or neurological assessment?
A No I think it was not.

Q Was a lumbar puncture in fact, in your view, clinically indicated in this case?
A No. As far as I could see, there was no indication, particularly as a lumbar puncture had been done before but, as I have mentioned in relation to earlier cases, obviously clinicians must be able to make up their own mind as to what is required and inevitably there will be differences among clinicians as to exactly what they see is required. My concern is not whether or not I personally would have dealt with it in the same way, but with the fact that it was done as far as I could tell without the kind of systematic assessment that all authorities recommend precedes decisions on investigations.

Q The last two short matters. The last of this child's two admissions was on 9 December 1996 so, again, as a matter of fact was that prior to the Ethics Committee conditions?
A Yes.

Q And, again, did you find any of the consent or patient information sheets that were envisaged?
A No.

MS SMITH: That is all I have to ask, thank you, about child 9. I do not know whether this would seem an appropriate place.

THE CHAIRMAN: Yes. It is now one o'clock so we will now break for lunch and we will resume at two o'clock. Once again, Professor Rutter, you are under oath. Please do not discuss this case.

MS SMITH: Sir, can I just mention here that I am obviously, to some extent, in the Panel's hands about what time they want to conclude this afternoon, not just in relation to the actual time chronologically but how many of these they feel comfortable with going through in one day. So you might like to give some consideration to how you would like me to time the afternoon when you come back from the luncheon adjournment. As I say, I am entirely in the Panel's hands. I am rather conscious that it is a long, tiring day for the witness as well.

THE CHAIRMAN: Yes. I think it is obviously important how much information the Panellists can also absorb in one day. What I will do, if it is acceptable to you, is during this lunch break I will have a word with the Panellists and maybe I can give you some indication when we resume at two o'clock.

MS SMITH: Of course, sir. Thank you very much.

THE CHAIRMAN: We will now adjourn and resume at two o'clock.

(The luncheon adjournment)

THE CHAIRMAN: Ms Smith. We had a small meeting to consider the suggestion that you had actually made. The Panel gave consideration not only to the aspect of how much they can absorb within a day, but also how much the witness can go through within one day. We felt that, maybe, we can go up to 4 o’clock if necessary, but as long as it does not cover more than two more children, so it is one or the other, you can take whichever you like.

MS SMITH: Whichever be the sooner.

THE CHAIRMAN: Up to 4 o’clock but no more than two more children.

MS SMITH: I think that is very helpful indication. Let us see where we are at the end of the next child. Professor Rutter, I am going to look at Child 5, page 10 in your report. As far as the Panel is concerned, you will need the GP and Royal Free records – in the GP records, as far as the referral circumstances are concerned, at page 106 please. This is the note, just so you are filled in, between the two, two of the GPs at the practice which this child went to, one GP writing a note, dated 30 September 1996, to the other saying:

“Re [Child 5]

Dr Wakefield, consultant gastroenterologist, Royal Free, rang and gave a very lengthy and convincing case for [Child 5] to be referred to Professor Walker Smith.”

Then the address and telephone numbers:

“As they have findings suggesting that there is an association between inflammatory bowel disease, enteritis causing a failure to absorb B12 which is needed to myelinate until age 10 [leading to] neurological problems/autism. Measles vaccine may be implicated but that is being researched and uncertain of implications. Anyway – see fax...”

which has disappeared.

“Parents are keen – will you refer – presumably is extra contractual.”

At this stage I am going to be asking about the pattern of referral when we have looked at all the cases, but at this stage I want to ask you what I have asked you previously in relation to other children. Is that, in your experience, a normal way for a referral to start?
A Not usual.

Q If we go to he GP records at page 105 we see the actual referral letter. To Professor Walker Smith dated 1 October 1996.
A Sorry, can I interrupt, I seem to be on the wrong file. We are on Child 10, are we?

Q Child 5.
A Sorry, my confusion.

Q It is because I said page 10 to you.
A Apologies.

Q It is page 10 in your report, Child 5. If you could turn to page 106 first of all. You were obviously listening to me read it out. That is the note I was reading out. I will not read it again but if you would run your eye down it.
A My answer is the same.

Q We are all clear you are referring to the right child?
A Yes, I was listening to you.

Q Then if you turn back to the previous page, page 105, you see the actual letter of referral?
A Yes.

“This 7¾ autistic child’s parents have been in contact with Dr Wakefield, and have asked me to refer him to yourself regarding your current study into the association between autism and childhood bowels problems.

[Child 5] has presented with developmental delay and severe communication problems and autism was diagnosed when he was aged 3. He had the classic systems of autism and appears to be continually frustrated by his inability to communicate with anybody. His behaviour has been very bizarre and he is often very difficult to contain within a room, house or garden. His parents have managed him remarkably well, but he needs one to one attention virtually all the time. His behaviour has become more violent in recent months and it is possible that he may be excluded from the school for mentally handicapped children. He has also seen...”

Then it lists Dr Williams, Consultant Clinical Psychologist; Dr Wallis Consultant Paediatrician; Dr Van Boxel at the Child Guidance Clinic and Dr Richer, Consultant Psychologist:

“His parents are concerned about an association they have read in the “Daily Mail” between MMR vaccine, childhood enteritis and possible brain damage. [Child 5] had his MMR vaccine on 10.04.90. He did not have pertussis vaccine, but three doses of diptheria, tetanus and polio, followed by another dose at age 3/12 years.”

That was the letter that was sent by the GP. Again I would ask you what I have asked in relation to other children, given to whom the GP was referring this child, is there anything striking to you with regard to the symptoms that he sets out in that letter?
A Yes, what is striking is that the referral is to a gastroenterological department, but there is no mention of gastroenterological problems. It is entirely in relation to autism on the one hand, contact with Dr Wakefield on the other and also the concern about allegations in the Daily Mail about MMR.

Q We can see that there were indeed those concerns because the next thing chronologically in the GP records is at page 98, which is a letter the vaccine damage unit indicating that the parents had concerns in relation to damage from inoculation. This child did indeed attend an outpatients’ appointment and Professor Walker Smith wrote after that letter to the general practitioner. We have that letter at page 361 of the Royal Free records. That is dated 12 November 1996 to the GP:

“Many thanks for referring this child with autism and disturbed behaviour. He demonstrated how difficult his behaviour can be when I saw him in the clinic and we did not proceed with any blood tests.”

It sets out the gastroenterological symptoms had that had been elicited in outpatients and it says:

“Several of these children with autism have had gastrointestinal symptoms and on investigations have proved to have gastrointestinal pathology. I am arranging him to come in for a colonoscopy on Sunday 1 December 1996.”

He was indeed admitted on that day. We can see what investigations he underwent and what they elicited by going to the discharge summary which is on page 360, the page before, which is the short form discharge notification. Although I should, just say in passing, that refers to an admission date of 2 December, we in fact know it was the 1st because he was clerked on 1 December. The procedures are colonoscopy, MRI scan, barium meal and follow through, EEG and evoked potentials. Just going through those investigations, the colonoscopy was on 2 December. Also on 2 December there was a request made for EEG and evoked responses. That is at page 453. This is again a request which is signed by Dr Wakefield. Again, can I ask you if this was a clinical investigation would you expect Dr Wakefield to be requesting?
A No.

Q The reason given for it was disintegrative disorder. Bearing in mind the chronology, the fact that this child had been admitted the day before and what had been said about his behaviour and history by the GP, was there any basis for Dr Wakefield giving that as a diagnosis justifying this investigation?
A Not as far as I can see on the evidence available in the records.

Q Then the next day, 3 December, the child was seen by Dr Berelowitz. We can see that both from the clinical records at page 9 and at the top of the page, the 3 December 1996:

“Seen by child psychiatry – letter to follow.”

There is then Dr Berelowitz’s signature. The actual report he subsequently wrote is on page 354, a letter this time to Dr Wakefield with a copy to Professor Murch dated 4 December 1996:

“Dear Andy

Thank you for asking me to see [Child 5]. I saw his mother and observed [Child 5] briefly on 3 December 1996.

His mother reported that the birth and pregnancy were fine and that [Child 5] was born a healthy baby and he initially seemed to be advanced in his milestones. However, from 18 months he began to lose his language, became less sociable and less responsive. Now he has few words, his play is not purposeful and his affection is muddled with aggression. Certain foods make his behaviour worse, but there is no correlation between bowel problems and his behavioural problems.

[Child 5] was diagnosed autistic at the age of 3 and was in special school but has now been excluded because of his aggression.

I think the likely diagnosis is a developmental disorder such as autism. However, I thought he was a slightly unusual looking child and so, obviously, the usual chromosomal studies need to done.”

Is there any indication that you have seen, Professor Rutter, that suggestion that the chromosomal study was done followed up at the Royal Free?
A I could not see it.

Q If this had been a clinical assessment of a child and that suggestion had been made by the psychiatrist, would you expect some sort of follow up with that observation?
A Certainly. One of the prompts, as it were, for the possibility of a chromosomal abnormality is an unusual physical appearance, what used to be called a funny looking child but that is no longer a politically correct statement. Nevertheless, the kind of noting that this child has an unusual physiognomy is an important lead.

Q The point being that the diagnosis might be completely different if there was some chromosome abnormality?
A Yes, certainly.

Q That is a brief letter Professor Rutter. With regard to previous letters we have looked at in relation to other children and what you have said about the depth of the assessment there, if this had been a full clinical assessment, would you have expected any more information in it?
A Yes, it is pretty brief and does not go into things at all thoroughly.

Q Are there any matters in particular that you would have expected a clinical assessment to have seen and investigated?
A A variety of things, for example, family history would be one obvious thing that should be considered and it may have been considered by Dr Berelowitz, but is not mentioned, certainly in the letter.

Q If we go on with the list of investigations he had, that is a psychiatric assessment, then there is an MRI which took place. We have a record of that on page 451. It indicates that the examination took place on 5 December and there was no abnormality to be seen within the brain substance.

Then there is an EEG also on 5 December, and that is at page 454. We can see from that that the patient was asleep throughout the test because he had already been sedated for the MRI earlier, and the conclusion was “within normal limits”. Also on the same page was the evoked potentials, which was reported on 6 December, and we see the conclusion that they were also a normal study.
A Yes, indeed.

Q In fact on 5 December this child also saw Dr Harvey, the neurologist, and if we go back to page 39 we see the note:

“In so far as I can get near him – CNS” –

that is central nervous system –

“Nothing abnormal detected.”

Then a reference to his plantar reflexes. He says:

“Parents have

(1) No doubt about the relationship to MMR or onset
(2) No doubt of normal earlier development” –

I think that says. I will ask you for your comments on that in a moment, but just running on first of all through the history, so that we can see that he had the programme of investigations, he had a barium meal and follow through on 5 December – the same day as he saw Dr Harvey – and a full discharge summary from that admission is on page 351. We see the diagnosis at the top – this is 27 December 1996, Child 5.

“Diagnosis: 1. Part of autistic spectrum
2. Persistent diarrhoea

… admitted to our ward at the Royal Free on 10th December for assessment of his persistent diarrhoea.”

All normal, no neo-natal problems, well to 18 months of age. During this period he had achieved his normal milestones. Walking at seven to nine months, and at 18 months was saying three or four words.

“He subsequently stopped talking and started making bizarre noises. He appeared to lose interest in his surroundings and was diagnosed at 3 years of age as having autism. Presently his condition is exacerbated by violent episodes which his parents find difficult to control. He has frequent mood swings … [and] a vocabulary of roughly 30 words …”.

Then it sets out the gastrointestinal history.

“His parents feel that the onset of his neuro-developmental symptoms stems from the period 2 months after having had the MMR vaccination which he received on the 10th April 1990. A few months subsequent to this he started losing his skills.

He had a colonoscopy …” –

and the results of that are set out. Blood tests were performed, and we see at the bottom:

“We are still awaiting results of his central nervous system MRI scan and lumbar puncture.”

Going over to the next page, no evidence of overt bowel disease, some hyperplasia.

“The barium would suggest the presence of a stricture which would be in keeping with Crohn’s disease. We will need to consider these findings at greater length when we review him in clinic.”

I refer to that because although it is gastroenterological, it explains why he was subsequently admitted again.

Before I go on to that next admission, Professor Rutter, could I just take you back to page 36, because it has been pointed out to me that I did not complete Dr Harvey’s note, because it goes on to the next page. If you go to 36, that is actually the completion of the note that I took you to on page 39. It simply says:

“3. Videos of his pre-MMR/autism behaviour”.

That is the third thing that the parents were referring to.

As I say, there was a discharge which suggested that he needed to be readmitted because there was a question of a stricture in keeping with Crohn’s disease, and he was readmitted on 15 January, apparently for a barium meal and follow through because of the stricture. That is on page 7 of the Royal Free notes. We see that at the top of the page, 15 January, “Admission for barium meal and follow through under sedation”, but it appears also on the same page that he underwent a lumbar puncture – half-way down the page. We see then that the lumbar puncture was unsuccessful at the first attempt, OK at second attempt, and that the CSF, at the bottom of the page, was sent for testing of electrophoresis and lactate, glucose and measles analysis”.

MR MILLER: Bloods ---

MS SMITH: I am sorry, Mr Miller is saying something to me, and I cannot hear what it is.

MR MILLER: It says “Bloods for”, above “CSF”.

MS SMITH: Yes. “Bloods for – fragile X” – and I cannot read the other two, I am afraid, so if Mr Miller wants me to ---

MR MILLER: Chromosomes.

MS SMITH: Chromosomes. And PBM?
(To the witness) I will take you through it, Professor Rutter, and Mr Miller can ask you anything he wants to.

He was discharged – and this also a case, I would say in passing, where the lumbar puncture caused problems. If we look at page 18 of the GP records, we see:

“Lumbar puncture under general anaesthetic, 15 January 1997, Royal Free London.
Drowsy since, screams when awake, complaining of back pains, vomiting twice this afternoon, screaming overnight.”

In fact there was an admission again to the Royal Berkshire Hospital for observation.

I will come back to your views on that lumbar puncture, Professor Rutter. With regard to his behavioural development, I have referred you to what Dr Berelowitz had to say, and if we look back into his past, which requires the GP records, he was referred first of all in January 1992 to a clinical psychologist, Dr Williams. That is at page 138 of the GP records. Dr Williams was writing to the psychiatric registrar from the community psychology team. Going down to the bottom of the first page:

“At one year he had convulsions which led to a further hospital admission but these appear to have been due to a high fever. From then on his parents noticed a difference in his development and feel that these febrile epileptic seizures continue to the present day. In general he showed a good physical development, sitting up at 3 months, walking round the furniture at 6 months and walk king properly at 11 months. At 10 months of age he was saying mummy and daddy but then became very miserable and appeared to lose ground in his development after he had been in hospital.

His parents record that [he] has always related to people well and in an affectionate manner. They describe how he runs over to his mother when she comes in but on the basis of my own observations I would suggest that this was in a fairly automatic manner …”.

Then in the next paragraph he says:

“[He] also shows a number of rituals which include carrying objects around from which he will not be parted.”

In the next paragraph:

“He is able to feed himself, climbs well, … not yet properly toilet trained. … does not wet the bed rather he gets out of bed and wets the floor beside the bed.

[He] presents a number of behaviour problems.”

Then on to the next page:

“Since first seeing the family in November, [he] has developed a habit of taking all his clothes off. This has resulted … in him being cold and being difficult to take out … but also in inappropriate defecation and urination. This is unlikely to be sorted out before the temper tantrums because as soon as any clothes are put on him he has a temper tantrum.

In conclusion then [he] is a boy with uneven development. It seems very likely to me that he is suffering from autism, that is he shows delays and deviance in language and communication development and social development together with rituals or other routines that sorted before the age of 3. This is a lifelong condition and whilst he will show some impairment in sociability over the years, he is unlikely to recover fully. His behaviour problems compound the difficulty of his management …” –

and he then goes into various suggestions in relation to that. So that is the first assessment of the problems that he has, that you refer to in your report. That is 1992. Then we go on for three years to March 1995, at page 123. This is a long letter from Dr Wallis, consultant paediatrician. Again I will not read the whole of it, but she says at the beginning that “the parents raised the following concerns”:

“1. Confirmation of the diagnosis of autism as they found the unevenness of [his] skills confusing. They had also read about newer forms of brain scan such as MRI and SPECT and wondered whether these would be helpful.”

Then indications that they wondered if a specific diet would be helpful, and sought information as to the way to encourage appropriate play.

Then turning on to the next page:

“Diagnosis of autism

This is usually made by completing a check list of behaviours” –

and she refers to those which she had looked at during the clinical session that she had with the child.

“Investigations into the cause of autism”.

She notes the complex family history, which she then sets out, and difficulties in relation to both autism and learning difficulties within the family. She says:

“I understand the family have been investigated in detail by the Clinical Genetics Department …

In 1991 Dr Newman carried out a number of investigations … and excluded a diagnosis of Fragile X … Other investigations which included a full blood count, biochemical screen, blood and urinary amino acids, were normal. Brain scan was not carried out as there were no indications to do so from either the history or physical examination and I found no further clinical signs to indicate a scan would be helpful. Reports on a series of MRI scans carried out in autistic children have shown evidence of congenital malformations, or non-specific brain damage in some children, but these findings have not been helpful in management.”

Can I just interrupt myself there to ask you, Professor Rutter, is that an allusion to one of the matters which you told us about when you were talking generally about the investigations that would assist, namely whether these investigations show anything or not, actually make a difference to how you mange the child thereafter?
A Yes, indeed.

Q Is that relevant – it may always be very interesting to know what a scan shows, but is that relevant to the clinical management of the child?
A That is the key question that clinicians always need to ask. It may be relevant either on diagnosis or management, but if the answer is that it is of theoretical interest only, but neither informs diagnosis nor informs management, then clearly that is not the sort of investigation that one would consider very useful.

Q Then she goes on:

“PET or SPECT studies are currently only used as a research tool and again I am not aware they have shown any specific features in autistic patients that either helped to confirm the diagnosis of alter management. I have asked [Mr 5] if he would let me have a photocopy of the information he has read … so we can discuss this together.”

So this was the family making enquiries, plainly, about further investigations that could be made, and we go on. Dr Wallis looked at the management of the behaviour, having looked at the signs that the child was showing, what might have caused it. We then see “Housing”, “Diet”, “Respite care” and a plan as to the possible future. Again can I ask you, is that in your view a thorough study of the position in 1995?
A Yes, it is thoughtful and well informed.

Q I am sorry?
A Thoughtful and well informed.

Q This is another case where we know that Dr Harvey in fact did see this child prior to him undergoing a lumbar puncture, and I have taken you to the notes that Dr Harvey wrote. Because he saw Dr Harvey, what conclusions do you draw as to the appropriateness of the lumbar puncture investigation?
A The same difficulty I had before, that is to say Dr Harvey as a consultant neurologist clearly ought to be able to take appropriate decisions on that, and given the need, if it is done on the basis of clinical care, to accept what is decided by the consultant concerned, then I think you have to accept that. If one asks a different sort of question, as to whether there is evidence in his own notes or others justifying it, then the answer is, “Well, no, that is strikingly absent”. It is a very perfunctory assessment. No mention is made of the unusual family history, no mention is made of looking for congenital anomalies; no mention is made linking up with the previous investigations, and so on.

The videotapes – I know he comments that they were available, but the question is did he look at them? Presumably he did not, in that no mention is made of anything that derives out of it. It is of course very time consuming looking at videos, but if one is going to draw conclusions from it, you cannot rely on what parents say is on the video, you have to see for yourself.

Q So, as I understand what you are saying, you are saying given that the neurologist saw him, you do not criticise the investigations undertaken but you cannot personally quite understand why Dr Harvey thought it was appropriate, is that fair?
A Exactly.

Q We know also that there had been a psychiatric assessment by Dr Berelowitz and that he echoed the previous views which had been that the child had a developmental disorder such as autism. Is there anything suggestive either in Mr Berelowitz's assessment or previously of disintegrative disorder?
A No.

Q Can you see anything that would justify his inclusion in a study on children with disintegrative disorder?
A No, because that is not the pattern he shows, or rather he showed at that time.

Q Again, this is a first admission on 1 December 1996 so does the same apply in relation to approval by the Ethics Committee on the condition that children were seen after December 1996?
A It does, indeed.

Q Were there any research consent forms in the form that they were submitted to the Ethics Committee that you can find?
A I do not think so.

Q Overall, Professor Rutter, the same question that I have asked you previously, what is your feeling as to whether this admission or these two admissions were for research or for clinical purposes?
A The overall impression given for the same sort of reasons discussed in relation to other cases is that it is much more in line with a research admission following the standard protocol, and that it is particularly striking that here there are quite a lot of things that are unusual about this case and have been considered in relation to earlier assessments, but those were not integrated in coming to decision making.

Q Yes, thank you. Just so that we are clear as to which child this is, I am not going to go into what is a very lengthy subsequent history because it is very much gastroenterological expertise rather than your own.
A Yes.

Q Having said that, I think you are aware, and can confirm, that there is a long history of PICA, of the eating of inappropriate objects, and that ultimately this child had to have surgery on two occasions for that purpose, to remove objects.
A Yes. PICA in children with these particular problems is very common and I would expect a systematic assessment to be made in relation to that. We have seen its relevance in relation to other children in relation to lead levels. In this case, that is not the issue, it is a question of an eating extraordinary mixture of metal objects, but that is of relevance of course in relation not only to the autism spectrum disorder but in terms of the gastroenterological implications so that this, in relation to the sort of children that I have seen over the years, is quite a common problem and it is one that is a matter of considerable concern. I cannot, of course, comment on the specific gastroenterological approaches, that is not my expertise, but I can comment that this is a common problem in relation to autism spectrum disorders.

Q Thank you very much, prove. That is all I have to ask about child 5. I am now going to go on to child 12. Child 12 is at page 16 in your report, Professor Rutter. I am going to move to the GP records and the Royal Free records.
A I am sorry, where is it in my report?

Q It is in your report at page 16.
A I am with you.

Q In fact, you say in your report that the process of referral was unclear and, just to remind everybody of what the factual situation is, we have in fact heard evidence from Mrs 12, and the process was that she met the mother of child 6 and 7 at a mother and toddler group and that she told her of the possible link between the type of problems that her child appeared to be experiencing and MMR and, in that context, gave to her Dr Wakefield's name. She contacted Dr Wakefield directly herself and then there was a phone call and a letter between them and then ultimately we have the formal documentation in relation to that. Just chronologically, I am sorry to have to ask you to go through another bundle, but if we go to FTP1, and that is page 129, prior to the admission to the Royal Free on 18 July 1996 there was a letter from Dawbarns, the solicitors in the MMR litigation, to Mrs 12 indicating that legal aid was being granted to the child. We see in the middle of the page:

"Legal aid is now being granted in vaccine damage cases where we can show a close link up in time between the vaccine being administered and the onset of recognised side effects."

In fact, as I say, this child was granted legal aid shortly thereafter. If you go on to FTP1 at page 242, that is the legal aid certificate for the little boy and was dated 9 October 1996. So that is the background which you mentioned in your report in relation to the litigation.
A Yes.

Q Now, if I can ask you to go back to the GP records, page 126, this is the letter that Dr Wakefield sent to Mrs 12 after she had contacted him in the circumstances I have described. He says:

“Dear Mrs 12,

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

We know that the next day he had a telephone conversation with Dr Stuart, the GP, and if we go to page 11 of these records, the GP records, you see in the middle of the page a note which starts “Call from Dr Wakefield”. Are you with me, the middle of the left hand column and the date of 20 July?
A Yes, I see.

Q "Call from Dr Wakefield. Needs colonoscopy, B12 absorption tests, history of measles vaccination reaction", I think that is.

Then, ultimately, there is the referral letter from the GP which is at page 124, from Dr Stuart, the address at the top, Professor John Walker Smith, but the letter addressed for the attention of Dr Wakefield.

"Thank you for seeing [12] who we have discussed on the phone recently. [12] initially presented at his eighteen month check with delay in talking and communication skills. He was seen locally at the Speech Therapy department and has been under the care of our local community paediatrician since that time with behavioural difficulties. He has been rather hyperactive and difficult to control and became easily distressed when his routine was changed. His early years with unremarkable apart from the usual upper respiratory infections. He had chicken pox in January 1992 and his routine MMR vaccine in March 1992. He has for sometime had bowel problems, but did not present to my surgery until March this year when Mrs 12 came along to discuss his soiling habit.

On examination at that time his abdomen was normal with an empty rectum. He has seen Dr Richard Ing, our local Consultant Child and Adolescent Psychiatrist, who has expressed the opinion that [12] may well have Asperger's Syndrome. He has two siblings, both of whom are well.

I look forward to hearing your opinion regarding [12's] further investigation and outlook."

Looking at that process of referral, Professor, again, is it your experience that it is a normal way for a clinical referral to come about?
A No, it is not.

Q Can you tell us what is unusual about it? What would you expect in a standard clinical referral process? How would it begin?
A Well, it would be a request to see the child in relation to whatever problem is being presented. Ordinarily, that problem would be in whatever was the area of expertise with respect to the consultant to whom referral is being made. Here there had already been discussion with the research worker concerned, i.e. Dr Wakefield, and that the focus in the letter is primarily on other things although, it does mention that he has had bowel problems for some time.

Q Yes. I think I can ask you this. I do not want to drag you into gastrointestinal issues so tell me if you do in the feel able to answer it. In the context of a child who apparently has behavioural problems and is thought to have some form of autism, would soiling in itself be necessarily indicative of a gastrointestinal problem?
A No. It is known to be very common so that in various series that had been looked at about a third of children have soiling problems. Now, of course, it could be argued that the aetiology of the soiling is uncertain and I am aware that the argument has been put that the children with gastrointestinal symptoms have been inadequately assessed elsewhere and hence the need for full assessment here. It is a common problem and it is associated with known things like PICA, like rituals in relation to going to the lavatory, reluctance to use the lavatory, of getting constipated and then getting blockage. So there are a variety of known causes as well as query additional causes so that, to give a shorter answer, soiling in itself would not necessarily indicate some additional problem. So you would want to know why, in this particular case, it was thought that that might be so.

Q I have asked you about whether you feel this was a normal referral. It resulted, in any event, in an outpatient appointment and blood tests were taken. Then there were two letters from Professor Walker Smith that I want to take you to. The first of 21 October 1996 is in the records at page 67. I am sorry, this is in the Royal Free records at page 67. It is dated 21 October 1996.

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

Then he writes to Dr Wakefield on the same day, which is the previous page, page 66:

"Dear Andy

It is interesting to see this child who really has the features of autism but rather minimal gastrointestinal symptoms. I did not feel it right in fact to proceed with our intensive programme at the moment until we have had Ethical Committee approval and it is clear that the parents wish us to proceed."

Now, in relation to those two letters, Professor Rutter, do they in your mind have any significance with regard to whether these were research investigations or clinical investigations?
A Well, I need to answer at a little bit of length.

Q Please.
A On the one hand, Professor Walker Smith is showing entirely appropriate caution about proceeding because, to link up with my answer to the previous question, his judgment was that actually this child, despite the fact of soiling, had rather minimal gastrointestinal symptoms in terms of the kind of things that one might link up with a enteritis of one kind or another. So that is responding, as it were, to the clinical side and is indicating a responsiveness to the particular features of this child. He then is expressing caution to Dr Wakefield about whether it is appropriate to proceed, at this stage, not giving a view one way or the other but saying we need to wait. The letter, of course, is also significant in indicating that he let Dr Wakefield know that ethical approval has not yet been obtained.

Q As far as the latter matter is concerned, if these investigations were clinically indicated, can you understand why he is saying that it does not feel it right to proceed without Ethical Committee approval?
A No, if it is on clinical need alone then one not only can but should proceed with whatever is indicated in relation to the individual child. The fact that the child does not have, apparently, the kind of gastroenterological disorder that fits in with the criteria for the study is really neither here nor there. It is directly relevant in relation to the research protocol but it is not relevant in terms of dealing with particular clinical issues.

Q That is dealing with the clinical side of it: if in fact the investigations were proposed as research investigations would you then agree with Professor Walker-Smith that they should not be proceeded with without the Ethics Committee approval for research investigations?
A Certainly.

Q We have again heard from Mrs 12 with regard to how the next events unrolled, but if we go to page 68 of the Royal Free records, that is a letter which was written on 20 October but apparently received on the 28th, so it is after the correspondence that I have just taken you to. It is addressed to Professor Walker-Smith:

“I am writing following [child 12’s] visit to the Royal Free Hospital last Friday … My husband and I have thought long and hard about this situation since the appointment. We have also reread Dr Wakefield’s proposed clinical and scientific study notes.

We do feel that [child 12] does have a problem in that most children his age do not soil themselves a number of times a day”

Then she goes into the details of the nature of the soiling and the fact she thinks it is very loose although she would not say it was diarrhoea:

“Obviously I do not wish to put my son through any procedures unnecessarily but there must be a reason why he has these problems. Also, as I mentioned to you at our meeting, [child 12] is not growing or putting on weight like my other two children.

I keenly await the results of the blood tests and if you feel they warrant further investigations my husband and I are happy for him to be referred on to Dr Wakefield’s study project. As you pointed out, it might not help [child 12] but if not hopefully it will be of benefit to others. There is also the chance that [child 12] has a problem that can be detected and helped.

I do hope to hear from you in due course.”

If Professor Walker-Smith did indeed say that to Mrs 12, that it might not help child 12 but if not hopefully it would be of benefit to others, again, can you tell us, is that consistent with a clinical or a research approach to the investigations that were proposed?
A No, that would be the sort of answer that one would always give in relation to a research study: that is to say the purpose is to gain knowledge. It may be that it will be of benefit to your child, but, as it were, that is ancillary, and if there happen to be benefits, great, everybody will welcome that but what you are requesting is permission for a study that is designed to gain knowledge – to gain knowledge in relation to the kind of disorder that your child has, so it is relevant in that broader sense but not relevant in the sense of being focused on providing help with the problems at that time, so that a perfectly appropriate way of responding in relation to a request to participate in research but it is not the way one would do it in relation to a clinical need.

Q Ultimately, a decision was made to admit this child because one of the blood results was slightly abnormal – and I am going to ask Professor Booth, our other expert, to deal with the significance or otherwise of that abnormality gastro intestinally, but I am going to take you to the letter to make the history of the admission clear. It is on page 38 of the Royal Free records:

“Dear [Mrs 12]

Many thanks for your letter of 20 October. I have now got back the blood tests. One was slightly abnormal. As I see that you are keen for us to proceed with investigation I think it would be appropriate for us to arrange for [child 12] to come in for a colonoscopy. I explained in the outpatients what this involved.”

Then he sets out the basic procedure:

“The children are usually admitted for the course of a week and various other aspects of the protocol are undertaken. If you would like to proceed with this please let my secretary know and we will arrange a date for [child 12] to come in in the new year.”

Then in November we see there is a letter at page 39 from Messrs Dawbarns solicitors to Professor Walker-Smith, a formal letter asking for the medical records in respect of Child 12 because of the proposed litigation. The child was admitted, and we can see the date of that on page 3, which is the printout., as an inpatient, at the bottom under “Patient episode summary” from 5 to 10 January 1997, again under the care of Professor Walker-Smith.

In order to see what tests the child underwent we can go to the discharge summary at page 32:

“Further to having been seen in clinic [child 12] was admitted to the Royal Free Hospital for further investigations of his gastro-intestinal problems ... He had been followed by paediatricians locally for one year because of poor apgars scores. Nevertheless, his development was recorded as normal until the age of 16 months. Subsequent to this is parents noticed a loss of language skills. He was also noted to stop playing and his behaviour has progressively deteriorated. Presently, he is noted to talk but often talks nonsense. Apparently, he finds it quite difficult to express himself and has poor social skills. He also manifests temper tantrums. These are not noted to be associated with any particular food substance.”

His gastrointestinal symptoms are set out:

“He had his measles vaccination at 15 months of age and is fully immunised …”

It then sets out a family history: blood tests performed and the results are given:

“A colonoscopy was performed under sedation, this recorded almost normal appearances to the caecum.”

The details of those are set out. Histology is recorded:

“A barium meal and follow through demonstrated lymphonodular hyperplasia of the terminal ileum.

It was notable that following the bowel clear out, prior to the colonoscopy, [child 12’s] behaviour appeared to improve, as did his soiling. It is therefore conceivable that many of his problems are associated with a degree of constipation in view of this he has been started on liquid paraffin medication.”

So the tests there are the colonoscopy, blood tests and the barium meal and follow through, and there are not any other tests set out there but if we go to the clinical notes we can see that there are references to others. The day of admission, on 6 January, which is page 19:

“Admitted for investigation of autism and bowel problems.

autism – ‘autistic spectrum’.” In inverted commas:
abdominal pain.

Development normal until age 16 months.
Had MMR at age 15 months.
Initially – noticed loss of language skills.
- stopped playing
- progressively deteriorated.

Now - can talk .
- finds it very difficult to express himself.”

The other details are also set out in the discharge summary.

If you go on to page 21, which is the same admission clerking notes, we see that the plan actually is not only the investigations which were subsequently in the discharge summary, bloods, colonoscopy, barium meal and follow through, but also MRI and LP (lumbar puncture).

Then further down on page 21, on 6 January, the next day, a ward round with Professor Walker-Smith, the results of the colonoscopy and then: “Not to have MRI or LP” and Wednesday to have his barium meal, so there were apparently instructions that he should not have those investigations, but despite that he did have a lumbar puncture and an MRI on 9 January. We have heard the evidence from Mrs 12 that those procedures were indeed carried out and we also see at page 104 the CSF results, and at page 120 are the results of the MRI scan showing that there had been no abnormality from that investigation.

So those took place on 9 January. On 9 January an attempt was made at an examination by Dr Harvey but he did not in fact do so, and that is at page 22. You will see the note in his distinctive handwriting at the top of the page:

“Fast asleep. I’ll call on him at home – I’m often in XXX.”

We have heard from Mrs 12 that in fact she has no recollection of the child subsequently being seen at home.

On 10 January child 12 has his EEG and that is at page 130. Again, that is apparently requested by Dr Wakefield, it is his signature at the bottom. Can I ask the same question: if that was a clinical investigation would you expect to see the request signed by him?
A No.

Q It has just been pointed out to me, it was an inadvertence by me, that it was not an EEG, it was the evoked potentials which were requested by him. Does the answer still stand in that case?
A The answer is still the same.

Q Then on 10 January the boy was seen child 12 was seen by Dr Berelowitz, and that we can see on page 18. These are the notes that Dr Berelowitz made … Forgive me a moment, I am being handed a note: could we go back so I am clear about the request. I do not want to be unfair to anyone, can I take you back to the investigations which were ordered by Dr Wakefield before I take you to Dr Berelowitz? If you go back to page 131 we see Dr Wakefield’s signature and the reason for the request is given as autistic spectrum disorder and bowel disorder following MMR, and the request is for both evoked potentials and for an EEG, and we can see the ticks in those boxes.
A Yes.

Q I took you to the wrong page and I apologise for that, so can I ask you the question again: if these were clinical investigations, either or both of them, would you expect to see the request from Dr Wakefield?
A No.

Q If I can go back to Dr Berelowitz’s notes on 10 January, page 18? We see a note which sets out the previous history: “Absolutely fine at 1 year … MMR at 15 months” then there is reference to the developmental delay from which he suffers, and at the bottom we see his diagnosis:

“Language delay, ?ADD; ? features of Asperger’s.”

What is “ADD”?
A Attention deficit disorder, so that is referring to his over activity.

Q Is that a component of autism or a different diagnosis?
A It is a different diagnosis but it is common also as a component of autism.

Q Asperger’s again you say ---
A It is a milder variety.

Q --- is a milder variety of autism. Those results did not filter through to the discharge summary. They were requested subsequently by the mother some time afterwards, some months later in fact, in June 1997, and that is at page 75. This is a telephone recorded note from Nurse Thomas, who we know was the research nurse involved:

“[Mrs 12] left a message 17.06.97. Returned call. Discussed with [Mrs 12] the results of the MRI, EEG and LP, which were reported as normal. I have explained that we do have some immunology results but I am unable to interpret them. Dr Wakefield will see [Mrs 12] in clinic on 4 July. I have also explained to [Mrs 12] that ideally we need more blood for immunology (T cell subsets) and we have planned to send Emla cream through the post to apply before visit.”

In other words, that is an antiseptic cream so that further bloods could be taken, is that correct?
A Yes.

Q Going back to the investigations which were ordered and took place: I have taken you to the history of how Professor Walker-Smith apparently said this child was not to have an MRI or an LP.

Q Were you able to see anything in the records which explained why, despite that instruction, this child went ahead and had those investigations?
A No, I looked but could not locate a request form as to who signed it and when, so that it does reflect the muddle, at least as experienced by me, in sorting out who was deciding what. To come back to my earlier response, Professor Walker Smith was showing entirely appropriate clinical decision making in relation to his approach for the admission, saying that, in this particular case, it did not seem relevant to move ahead in the way planned. It was slightly muddied then by the letter saying that in view of the parents wanting to go ahead so much, that maybe they should go ahead, but the parents had been clear that they were keen to go ahead for a research investigation and so that is where there is the confusion as to whether we are talking now about clinical need or research. Then, to come back to the admission, there is a clear statement in the records that on Professor Walker Smith’s ward round he made an explicit statement, which I have to presume is accurately reported in the notes, that this child should not have the MRI and lumbar puncture. It is baffling as to why the child, despite the senior consultant, Professor, making a statement of that kind, on the basis of a ward round – so it is not just a passing comment in the corridor – why this went ahead. This is the kind of worry that one has, that on the one hand there are experienced clinicians some times taking entirely appropriate decisions and on the other hand there is this steam rollering ahead with a set of decisions that are driven by research needs not by clinical needs. As I do not know who ordered what investigations when, I cannot comment any further than that, other than to say that one is left with a clear statement as to what should not happen but is then immediately followed by equally clear statements that it did happen.

Q In that context, if I could ask you to turn back to page 21, Royal Free Child 12. Above the instruction from Professor Walker Smith we see the plan when this child is first admitted, which is the bloods, colonoscopy, barium meal and follow through, MRI, LP. Does that accord with the investigations in the research protocols submitted to the ethics committee?
A It does.

Q I am going to ask you some overall questions about this case, but I want to refer you to the two letters that you refer yourself to informing yourself as to the behavioural background. Sir, I do not know if you would like me to go straight on. I can tell you that, in so far as I am able to assess it, I am never very brilliant at this, you do have time for a short tea break and finish the second child and it not be later than a very few minutes past 4 o’clock. It is more by luck than judgment I have to say.

THE CHAIRMAN: We will have a 15 minute break and return at 3.40 pm. Can I, again Professor, remind you that you are still under oath and in the middle of giving evidence.

(The Panel adjourned for a short while)


MS SMITH: If we can turn to the documents that you felt were helpful on the behavioural background. It is summarised in an informative letter in the GP records at page 127. We can see from that that there had already been a referral in 1996 to Dr Ing, who is the Consultant Psychiatrist who is referred to in the GP referral to the Royal Free. It is a letter to the Community Paediatrician at the school, so the referral had come from there:

“[Mrs 12] was seeking my attention as to whether [Child 12] had Asperger’s Syndrome as well as looking at the strategies for managing him. The current difficulties are that [Child 12] is continually talking or making noises and that his effective response to situations can be extreme and unpredictable. His mother has recognised that he has been ‘different’ in some way since 18 months old. He soils most days though he is not apparently constipated. He seems oblivious to this, though on one occasion his mother found that he had hidden some pants which were dirty. He is very messy at feeding and it appears that for several days he may be uninterested in food only to compensate later by eating greedily. He is recognised to have delay in language and in motor skills, but is quite skilled at numeracy. He has a hand flapping habit and a habit of twisting ribbons attached to his teddy bear, such that these have had to be replaced several times. He copes poorly with changes in routine, such as a different teacher and become extremely distressed if his ribbons are missing. He collects small discarded objects...”

Going down to the next paragraph:

“At his 18 month check the health visitor detected his deficits in talking and drawing...Attention Deficit Disorder was mentioned and [Child 12] was referred to Speech Therapy...”

It was suggested by the psychologist who saw him that he was on the autistic spectrum.

“While mother had read about hyperactivity and concluded herself that this did not fit [Child 12] she has since...”

and I think it should be “read about”:

“Asperger’s syndrome and feels that the description fitted him exactly. Medically frequently unwell and prone to infection and stomach aches.”

Then it is just refers to the family history and says at the bottom:

“I would agree with the possibility that [Child 12] has Asperger’s syndrome. I intend to get further information from [the school] and I have arranged to meet [Child 12’s] mother to discuss the matter further.”

In September 1996 there is a GP record at page 121. This was an assessment at the Newcomen Centre at Guy's Hospital, in fact, to help with the research project into communication development. You mention in your report, if we look down under formal assessment, an assessment done by Dr Baird. Is she also a child consultant psychiatrist?
A She is a developmental paediatrician, but very experienced in this field.

Q Yes. It says that on a particular assessment which she did that on the test of thinking ability he scores average but his achieved level of reading ability is below average. The rest of the findings were that there was impairment in respect of language. You then refer to a later assessment which you say is undated in your report but, in fact, it is undated but the context suggests that it is 2003. I am going to it because it informs your views and confirms the findings of this report. It is at page 195. If we look at page 195, this assessment came up with a verbal IQ of 96, a performance IQ of 97, a full scale IQ of 96 and, on page 194, a total language score which shows that the child was in the fourth percentile. This, as I say, is in the context of a report, again if we look back to page 190, which was done at the Newcomen Centre at Guy's. Overall that tells us what about the psychological testing that was done on this child, Professor?
A Yes, it does, it is a very thorough assessment and it is at a clinic which is widely known as very expert in this area.

Q Just turning, and I hope you have not forgotten during the tea break the chronology of this, but I can remind you, to the neuro-psychiatric assessment at the Royal Free, or the lack of it, we know there is no report from Dr Berelowitz and you will recall that the only time Dr Harvey saw the child he was unable to assess him because he was asleep. In those circumstances, was there any indication of investigations or assessments at the Royal Free which could lead to a diagnosis of disintegrative disorder?
A No, there is not.

Q Or, indeed, any indication of why it might have been thought that there was any significant regressive elements about his behavioural disorder?
A No, no evidence that I could identify.

Q In those circumstances, was there anything justifying his inclusion in a study of disintegrative disorder?
A No.

Q With regard to the lumbar puncture, we have seen the slightly odd circumstances in which that was carried out but, whatever they were, given that there was no psychiatric or neurological assessment done at the Royal Free I am sorry, I should have said that there was no neurological assessment done at the Royal Free. Was it, in your view, an acceptable decision to carry out a lumbar puncture?
A No, I do not think it was.

Q If I can just take you back, Professor Rutter, to the previous question that I asked you in relation to the neuro-psychiatric assessment so that we are clear, we know that Dr Berelowitz did see the child, that was my mistake, but that the assessment that he made was query attention deficit disorder, query Asperger's, which you have been told is a mild form of autism
A Yes.

Q I will ask the question again. Was there any evidence that you could see that was acquired at the Royal Free that would have led to a diagnosis of disintegrative disorder?
A No. Although Dr Berelowitz's account is really quite brief, it is in keeping with the Newcomen Centre's much fuller appraisal. Asperger's Syndrome, as we have discussed, is a milder variety on the autism spectrum. It is not at all like disintegrative disorder.

Q Then, reverting to the lumbar puncture, you have told us that in the light of the lack of neurological input, you did not think that it was acceptable to make that decision. Given the clinical picture as far as you can ascertain it from records was it, in your view, clinically indicated?
A No, I do not think it was.

Q Given that, what is your view again as to the overall pattern of this case in relation to its research or clinical nature?
A I think both in terms of the referral but more particularly in terms of the fact that the research protocol was proceeded with come what may, in spite of a clear statement that the child should not have MRI and lumbar puncture, one has to see this as driven by research rather than clinical need. Of course, one has got to go on to say that even if one viewed it as a research case, it clearly does not fit the criteria put forward in the research protocol.

Q The last matter, as I always ask you, could you find any consent form or patient information leaflet which was envisaged in relation to the research study included in these records?
A I think not.

Q But you have told us that if the information was given to Mrs 12 in the terms that she sets out in her letter, then that would indeed have been appropriate information to give if this had been a research study?
A Yes.

MS SMITH: Thank you, Professor Rutter. That is all I have, sir, on that child.

THE CHAIRMAN: Thank you very much indeed, Ms Smith. Professor Rutter, you heard me saying before, we will now be adjourning for the weekend. I think that it is not appropriate to leave any witness under oath over the weekend but I am afraid we have no choice.

THE WITNESS: That is quite all right. I understand and accept.

THE CHAIRMAN: Thank you very much indeed. Please make sure that you do not discuss this case with anyone, including any of the lawyers. We will now adjourn and resume at 9.30 am on Monday morning. Have a nice weekend.

(The Panel adjourned until 9.30 am on Monday, 1 October 2007)

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